Cobas C 311 Analyzer: Operator's Manual Software Version 01-04

cobas c 311 analyzer
Operator’s Manual
Software Version 01-04
Document information
Revision history Manual version Software version Revision date Changes

1.0 01-01 November 2007
2.0 01-04 December 2010 o General Update
o Implementation of the
addendum
Edition notice Operator’s Manual for users of the cobas c 311 analyzer.
Every effort has been made to ensure that all the information contained in this
document is correct at the time of issue. However, Roche Diagnostics GmbH reserves
the right to make any changes necessary without notice as part of ongoing product
development.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Software updates may only be carried out by Roche service representatives.
Intended use The cobas c 311 analyzer is an automated, discrete clinical chemistry analyzer
intended for the in vitro quantitative/qualitative determination of analytes in body
fluids. It is important that the operator reads this manual thoroughly before using the
analyzer.
Copyright  2007-2010, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS INTEGRA and LIFE NEEDS ANSWERS are trademarks
of Roche.
All other trademarks are the property of their respective owners.
Roche Diagnostics
2 Operator’s Manual · Version 2.0
Instrument approvals The cobas c 311 analyzer meets the protection requirements laid down in IVD
Directive 98/79/EC. Furthermore, our instruments are manufactured and tested
according to the following international standards:
o IEC 61010-1: 2001
o IEC 61010-2-010: 2003
o IEC 61010-2-081: 2001
o IEC 61010-2-101: 2002
o UL 61010-1: 2001
o CAN/CSA C22.2 No. 61010-1-04
o EN 61326-2-6:2006
The Operator’s manual meets the requirements of European Standard EN 591.
Compliance is demonstrated by the following marks:
Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

US.
C ® US
Contact addresses
Manufacturer Hitachi High-Technologies Corporation

24-14. Nishi-shimbashi. 1-chome. Minato-ku
Tokyo. 105-8717 JAPAN
Authorized Representative Roche Diagnostics GmbH

Sandhofer Strasse 116
D-68305 Mannheim
Germany
Roche Diagnostics
Operator’s Manual · Version 2.0 3
Roche Diagnostics
Table of contents
Document information 2 6 Daily operation

Contact addresses 3 Overview B–37
Table of contents 5 Starting the analyzer B–38
Preface 7 Preroutine operation B–48
Where to find information 7 Routine Operation B–65
Online help system 8 Shutting down the analyzer B–81
Customer information 8
Conventions used in this manual 9 7 Orders and results
Overview B–87
Test Selection screen B–88
System description Part A Data Review screen B–105
Open test requests B–112
1 General safety information General pipetting priority B–121
Safety classifications A–5 Preparing a DVD disk B–122
Safety precautions A–6
Safety summary A–8 8 Reagents
Safety labels of the system A–14 Reagent concept B–129
Disposal of the analyzer A–20 cobas c packs B–133
Handling of reagents B–135
2 Description of the analyzer Reagent screen overview B–138
Overview A–23 Reagent Setting screen B–139
Power switches A–27 Reagent Status screen B–140
Control unit A–28 Reagent Overview button B–143
cobas link A–31
Sampling area components A–37 9 Calibration
Reagent area components A–44 Calibration concept B–151
Reaction disk area components A–49 Calibration Screen Overview B–156
ISE area components A–59 Calibration Status screen B–156
Behind the front doors A–64 Calibration Install screen B–166
Rear view A–66 Calibration Calibrator screen B–174
System Overview screen B–176
3 Specifications
System specifications A–71 10 QC
Control unit A–73 QC concept B–179
Analytical unit A–74 QC Status screen B–184
Other specifications A–77 QC Run Status screen B–188
QC Individual screen B–190
QC Cumulative screen B–199
Operation Part B QC Control screen B–200
QC Install screen B–202
4 Safety information for operation Programming auto QC measurements B–209
5 Software basics 11 Configuration

General description of the user interface B–7 Application B–213
Fixed areas B–8 System configuration B–235
Main menus B–11 Module Set B–247
Software elements B–17 Calculated Tests B–249
The help system of the instrument B–24 Special Wash B–255
Shortcut keys B–32 Report Format B–261
Saving system parameters B–265
Restoring system parameters B–267
Roche Diagnostics
Maintenance Part C
12 Safety information for maintenance
13 General maintenance
Overview C–7
Maintenance items C–8
Maintenance pipes C–10
Maintenance types C–19
Maintenance report C–23
List of maintenance items C–24
List of maintenance checks C–28
14 Maintenance of the analyzer

Maintenance schedules C–33
Periodic replacement of parts C–45
Daily maintenance C–46
Weekly maintenance C–58
Monthly maintenance C–68
Every two months maintenance C–87
Quarterly maintenance C–92
Every six months maintenance C–110
As needed maintenance C–122
Troubleshooting Part D
15 Data alarms
Introduction D–7
Data alarm list D–8
Data alarms (ISE unit) D–10
Data alarms (photometric unit) D–19
Alarms for calibrations D–28
Data alarms for controls D–39
Data problems without alarm D–43
Rerun list D–47
16 Troubleshooting
General troubleshooting D–51
General instrument troubleshooting D–56
ISE troubleshooting D–59
Troubleshooting of the photometric unit D–66
Glossary Part E
Glossary E–3
Index Part F
Index F–3
Roche Diagnostics
Preface
The cobas c 311 analyzer is an automated, software-controlled analyzer for clinical

chemistry analysis. It is designed for both quantitative and qualitative in vitro
determinations using a large variety of tests for analysis. The cobas c 311 analyzer
performs photometric assays and ion-selective electrode measurements and uses
serum/plasma, urine, CSF, and supernatant sample types.
This manual contains a detailed description of the cobas c 311 analyzer’s features and
general operational concepts, specification functions and use of controls, operating
techniques, emergency procedures, product labeling and maintenance procedures.
Observe the instructions of the Operator’s Manual for safe operation of the system
o If the system is used in a manner not specified in this Operator’s Manual, the
protection provided by the system may be impaired.
o Keep this manual in a safe place to ensure that it is not damaged and remains available
for use.
o This Operator’s Manual must be easily accessible at all times.
Where to find information
The following documents are provided to assist you in finding desired information
quickly:
Operator’s Manual Contains information about safety, hardware components and operating the analyzer
as well as maintenance and troubleshooting. A table of contents at the beginning of
the manual as well as at the beginning of each chapter, and an index at the end of this
manual help you to find information quickly.
Online Help Contains a detailed description of the software of the cobas c 311 analyzer. In
addition to the software description, the whole Operator’s Manual is included in the
Online Help. This makes it possible to retrieve information from both Online Help
and Operator’s Manual using the search functions available for electronically stored
documents.
COBI CD The COBI CD (Compendium of Background Information) provides you with

background information about the technologies, test principles, their theory and the
calibration methods used by the cobas c 311 analyzer. It also provides a complete
glossary. The information can be read and printed using Adobe Acrobat Reader.
You cannot run the COBI CD on the cobas c 311 analyzer because you need Adobe
Acrobat Reader to view the COBI CD. Adobe Acrobat Reader is not installed on the control
unit and must not be installed.
Roche Diagnostics
Online help system
The software of the cobas c 311 analyzer has a context-sensitive online help feature to
aid you in operating the instrument. “Context-sensitive” means that wherever you
are located within the cobas c 311 software, choosing the help feature displays help
text relating to that area of the software. The online help system offers a quick and
convenient way to find information, such as explanations of screens and dialog boxes
and how to perform particular processes.
F1 Help There are two ways to enter the online help system: Via the help icon in the bottom
left of the screen or by pressing F1 on the keyboard. The context-sensitive entry
displays information relating to your current location in the software.
Customer information
Customer training Contact your local Roche service representative for any questions or information
regarding cobas c 311 analyzer training.
Contact customer service Contact your local Roche service representative for further information regarding the
cobas c 311 analyzer service agreement.
Ordering information Replacement parts, consumable materials, reagents, calibrators and controls should
be ordered from Roche Diagnostics. When ordering, please use the Roche
Diagnostics catalog number and reference name for each item. Contact your local
Roche service representative for the detailed ordering list.
Roche Diagnostics
Conventions used in this manual
Visual cues are used to help you locate and interpret information in this manual
quickly. This section explains the formatting conventions used in this manual.
Symbols The following symbols are used:
Symbol Used for

Safety alert symbol
Tip
a Start of procedure
 End of procedure
o List item
e Cross-reference
f Path to the active window or screen
Electrical and electronic equipment marked with this symbol are
covered by the European directive WEEE.
The symbol denotes that the equipment must not be disposed of in
the municipal waste system.
Abbreviations The following abbreviations are used:
Abbreviation Definition
A
ANSI American National Standards Institute
ASCII American Standard Code for Information Interchange
AU Analytical Unit. In the analyzer software this abbreviation is
sometimes also used to distinguish the photometric unit (AU) from
the ISE unit (ISE).
C
Cfas Calibrator for automated systems
CLAS 2 Clinical Laboratory Automation System 2
COBI CD compendium of background information
CSA Canadian Standards Association
CSF cerebrospinal fluid
CV coefficient of variation (%)
D
DAT Drugs of Abuse Testing
dB(A) decibel weighted against the A-frequency response curve. This curve
approximates the audible range of the human ear.
DIL diluent
E
EC European Community
EMF electromotive force
EN European Standard
Roche Diagnostics
Abbreviation Definition
H
HbA1c Hemoglobin A1c, glycosylated hemoglobin
I
ICVC initial cassette volume check
IEC International Electrotechnical Commission
INC. incubator bath
IS internal standard for the ISE unit
ISE ion selective electrode (ISE unit)
IVD in vitro diagnostic
IVDD In vitro diagnostics directive
K
KCL potassium chloride, reference solution for ISE unit
kVA kilovolt-Ampere. Unit for expressing rating of AC electrical
machinery.
L
LIS laboratory information system
LLD liquid level detection
M
MSDS material safety data sheet
N
n/a not applicable
P
P photometric unit of the analyzer
Q
QC quality control
R
RCM reaction calculation mode
REF reference solution for ISE unit
S
SD standard deviation
SIP ISE sipper syringe
STAT short turn around testing
Std standard, commonly used for calibrator
T
TDM Therapeutic Drugs Monitoring
U
UDF Universal Disk Format
UL Underwriters Laboratories Inc.
Roche Diagnostics
System description A
1 General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Description of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
3 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-69
cobas c 311 analyzer 1 General safety information
Table of contents
General safety information
Before you start working with the cobas c 311 analyzer, it is essential that the
warnings, cautions, and safety requirements contained in this manual, as well as the
explanations of the safety labels to be found on the analyzer are read and understood
by the user.
In this chapter Chapter 1

Safety classifications ........................................................................................................ A-5
Safety precautions ........................................................................................................... A-6
Operator qualification .............................................................................................. A-6
Safe and proper use of the analyzer ........................................................................ A-6
Miscellaneous safety precautions ............................................................................ A-7
Safety summary ............................................................................................................... A-8
Warning messages .................................................................................................... A-8
Electrical safety .................................................................................................... A-8
Biohazardous materials ...................................................................................... A-8
Reagents and other working solutions ............................................................ A-9
Waste .................................................................................................................... A-9
Caution messages .................................................................................................... A-10
Mechanical safety .............................................................................................. A-10
Reagents and other working solutions .......................................................... A-10
Insoluble contaminants in samples ................................................................ A-11
Evaporation of samples or reagents ............................................................... A-11
Cross contamination of samples .................................................................... A-11
Fatigue due to long hours of operation ......................................................... A-11
Spillage ............................................................................................................... A-11
Data security ...................................................................................................... A-12
Notices ...................................................................................................................... A-13
Moving parts ..................................................................................................... A-13
Circuit breakers and fuses ............................................................................... A-13
Safety labels of the system ............................................................................................ A-14
Front view ................................................................................................................ A-16
Side view ................................................................................................................... A-17
Top view ................................................................................................................... A-18
Rear view .................................................................................................................. A-19
Disposal of the analyzer ............................................................................................... A-20
Roche Diagnostics
Operator’s Manual · Version 2.0 A-3
1 General safety information cobas c 311 analyzer
Table of contents
Roche Diagnostics
A-4 Operator’s Manual · Version 2.0
Safety classifications
Safety classifications
This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the
ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons:
The safety alert symbol by itself (without a signal word) is used to promote awareness to
hazards which are generic or to direct the reader to safety information provided elsewhere
in the document.
These symbols and signal words are used for specific hazards:
WARNING
Indicates a hazardous situation which, if not avoided, could result in death or serious
WARNING injury.
CAUTION
Indicates a hazardous situation which, if not avoided, could result in minor or moderate
CAUTION injury.
NOTICE NOTICE
Indicates a hazardous situation which, if not avoided, may result in property damage.
e For more information about the product safety labels, see

Safety labels of the system on page A-14.
Important information which is not safety relevant is indicated by the following

symbol:
Tip
Indicates additional information on correct use of the analyzer or useful tips.
Roche Diagnostics
Safety precautions
Safety precautions
Particular attention must be paid to the following safety precautions. If these safety
precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is
important.
Operator qualification
Operators are required to have a sound knowledge of relevant guidelines and

standards as well as the information and procedures contained in the Operator’s
Manual.
o Do not carry out operation and maintenance unless you have been trained by
Roche.
o Carefully follow the procedures specified in the Operator’s Manual for the
operation and maintenance of the analyzer.
o Leave maintenance, installation or service that is not described in the Operator’s
Manual to trained Roche service personnel.
o Follow standard laboratory practices, especially when working with biohazardous
material.
Safe and proper use of the analyzer
Personal protective equipment o Be sure to wear appropriate protective equipment, including, but not limited to,
safety glasses with side shields, fluid resistant lab coat, and approved disposable
gloves.
o Wear a face shield if there is a chance of splash or splatter.
Accuracy/precision of measured An incorrect result may lead to an error in diagnosis, therefore posing danger to the
results patient.
o For proper use of the instrument, measure control samples and monitor the
instrument during operation.
o Do not use reagents, calibrators, or quality controls that have exceeded their
expiration dates. Observe the specified storage conditions. Otherwise, inaccurate
results may be obtained.
o For diagnostic purposes always assess the results in conjunction with the patient’s
medical history, clinical examination and other findings.
Installation o Installation must be performed by trained Roche service personnel only.

o Leave installation that is not described in the Operator’s Manual to trained Roche
service personnel. Follow the described installation instructions carefully.
Roche Diagnostics
Safety precautions
Operating conditions o Operation outside of the specified ranges may lead to incorrect results or
malfunction of the instrument (see Specifications on page A-69).
o Use the instrument indoors only and avoid heat and humidity.
o Make sure that the analyzer's ventilation openings remain unobstructed at all
times.
o Perform maintenance according to the specified intervals to maintain the
operating conditions of the instrument.
o Keep the Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use. This manual must be easily accessible at all times.
Approved parts Use of non-approved parts or devices may result in malfunction of the instrument
and may render the warranty null and void. Only use parts and devices approved by
Roche.
Third-party software Installation of any third-party software that is not approved by Roche may result in
incorrect behavior of the analyzer. Do not install any non-approved software.
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage may damage the analyzer or lead to
data loss. Perform regularly backups of measurement results. Operate only with an
uninterruptible power supply. Do not switch off power while the PC accesses the
hard disk or diskette.
Electromagnetic fields Devices that emit electromagnetic waves may cause the instrument to malfunction.
Do not operate the following devices in the same room where the analyzer is
installed:
o Mobile phone
o Transceiver
o Cordless phone
o Other electrical devices that generate electromagnetic fields
Instrument unused for an If the instrument is not used for an extended period of time, the main circuit breaker
extended period of time switch must be set to OFF. Remove and refrigerate any remaining reagents. For
further information, call technical support.
Relocation and transportation Do not attempt to relocate or transport the analyzer. Leave relocation and
transportation to personnel trained or authorized by Roche.
e For information about disposal of the analyzer, see:
Disposal of the analyzer on page A-20
Roche Diagnostics
Safety summary
Safety summary
This safety summary contains the most important and general warning and caution
messages. Additionally, you will find specific safety information at the beginning of
Part Operation and Part Maintenance.
Warning messages
List of warning messages

Before operating the analyzer, read the warning messages contained in this summary
WARNING carefully. Failure to observe them may result in death or serious injury.
Electrical safety
Electrical shock by electronic equipment

Removing the covers of electronic equipment can cause electrical shock, as there are high
WARNING voltage parts inside. In addition, opening the top cover and touching the ultrasonic mixing
mechanism during operation can also cause electrical shock.
o Do not attempt to work in any electronic compartment.
o Do not remove any cover of the instrument other than those specified in the Operator’s
Manual.
o Do not open the top cover and touch the ultrasonic mixing unit during operation or
when the analyzer performs maintenance.
o Installation, service, and repair must only be performed by personnel authorized and
qualified by Roche.
o Observe the system safety labels illustrated on pages A-16 to A-19 and in particular the
following: F-5, R-1.
Biohazardous materials
Infection by samples and associated materials

Contact with samples containing material of human origin may result in infection. All
WARNING materials and mechanical components associated with samples of human origin are
potentially biohazardous.
o Follow standard laboratory practices, especially when working with biohazardous
material.
o Keep the top cover and the front cover closed and in place while the instrument is
operating.
o When working with open top cover while the instrument is powered on (e.g., for
cleaning or maintenance), always put the analyzer in Maintenance mode or in
Shutdown status first.
o Be sure to wear appropriate protective equipment, including, but not limited to, safety
glasses with side shields, fluid resistant lab coat, and approved disposable gloves.
o Wear a face shield if there is a chance of splash or splatter.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If sample or waste solution comes into contact with your skin, wash it off immediately
with soap and water and apply a disinfectant. Consult a physician.
Roche Diagnostics
Safety summary
Infection and injury due to sharp objects

When wiping probes, use several layers of gauze and wipe from the top down.
WARNING o Be careful to not puncture yourself.
o Be sure to wear appropriate protective equipment, for example gloves. Take extra care
when working with protective gloves; these can easily be pierced or cut, which can
lead to infection.
Reagents and other working solutions
Skin inflammation or injury caused by reagents and other working solutions

Direct contact with reagents, detergents, cleaning solutions, or other working solutions
WARNING may cause skin irritation, inflammation, or burns.
o When handling reagents, exercise the precautions required for handling laboratory
reagents. Be sure to wear protective equipment (such as goggles, gloves).
o Observe the cautions given in the package insert, instructions for use in cobas link
and observe the information given in the Material Safety Data Sheets available for
Roche reagents and cleaning solutions.
o If a reagent, detergent or other working solution comes into contact with your skin,
wash it off immediately with water and apply a disinfectant. Consult a physician.
Waste
Infection by waste solution

Contact with waste solution may result in infection. All materials and mechanical
WARNING components associated with the waste systems are potentially biohazardous.
o Be sure to wear protective equipment. Take extra care when working with protective
gloves; these can easily be pierced or cut which can lead to infection.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If waste solution comes into contact with your skin, wash it off immediately with water
and apply a disinfectant. Consult a physician.
o Observe the system safety labels illustrated on pages A-16 to A-19 and in particular the
following: F-3, F-6, S-1, R-3.
Waste must be treated in accordance with the relevant laws and regulations. Any
substances contained in reagents, calibrators, and quality controls, which are legally
regulated for environmental protection, must be disposed of according to the
relevant water discharge facility regulations. For the legal regulations on water
discharge, please contact the reagent supplier.
Two kinds of liquid waste are discharged by the analyzer:
o Concentrated waste solution that contains highly concentrated reaction solution.
This waste must be treated as infectious waste as specified by the relevant
regulations.
o Dilute waste: A non-concentrated waste solution diluted with rinsing water from
cell wash or water from the incubation bath. When using NaOH-D for washing
the reaction cells, alkaline concentration is 0.1 to 1.0 mmol/L in terms of sodium
hydroxide equivalence.
Roche Diagnostics
Safety summary
Contamination of the environment due to inappropriate treatment of waste

All materials that have come into contact with human blood or blood products are
WARNING potentially biohazardous. Therefore liquid waste and replacement parts such as reaction
cells and ISE electrodes must be treated as infectious medical waste.
o When disposing of any waste generated by the analyzer, do so according to the
relevant laws and local regulations.
e For information about disposal of the instrument, see

Disposal of the analyzer on page A-20
Caution messages
List of caution messages

Before operating the analyzer, read the caution messages contained in this summary
CAUTION carefully. Failure to observe them may result in minor or moderate injury.
Mechanical safety
Personal injury due to contact with moving parts

o Keep the top cover and the front cover closed and in place while the instrument is
CAUTION operating.
cleaning or maintenance), always put the analyzer in Maintenance mode or in
o Only trained personnel should have access to the keys to the protective covers of the
instrument.
o Do not touch any parts of the instrument other than those specified. Keep away from
moving parts during instrument operation.
o Only load samples onto the sample disk when the green Access Sample Disk lamp
next to the sample disk is on. This indicates that the sample disk will not rotate until
renewed operation is actively initiated by the operator.
o During operation and maintenance of the instrument, proceed according to the
instructions.
o Observe the system safety labels illustrated from page A-16 to A-19 and in particular
the following: F-1.
Reagents and other working solutions
Incorrect results due to incorrect reagent volume

Application faults may cause an undetectable loss of reagent.
CAUTION o Store reagents always according to specified storage conditions.
o Do not reuse a cobas c pack or other cassette whose reagent has been spilled.
o Do not use a single cobas c pack for different instruments.
Roche Diagnostics
Safety summary
Insoluble contaminants in samples
Incorrect results and interruption of analysis due to contaminated samples

Insoluble contaminants in samples and bubbles or films inside a sample container may
CAUTION cause clogging or pipetting volume shortage and lead to deterioration in measurement
accuracy.
When loading samples on the instrument, make sure that samples contain no insoluble
contaminants such as fibrin or dust.
Evaporation of samples or reagents
Incorrect results due to evaporation of samples or reagents

Evaporation of samples or reagents may lead to incorrect results.
CAUTION o Do not leave samples, calibrators, or quality controls that have been pipetted into a
sample container for any length of time.
o Do not use expired reagents. Do not leave reagents on the analyzer for a protracted
period of time.
Cross contamination of samples
Incorrect results due to carryover

Traces of analytes or reagents may be carried over from one test to the next.
CAUTION Take adequate measures to safeguard additional testing and to avoid potentially false
results.
e For more information about avoiding carryover and cross-contamination between tests,
see Special Wash on page B-255.
Fatigue due to long hours of operation
Fatigue due to long hours of operation

Looking at the monitor screen over an extended period of time may lead to eye strain or
CAUTION body fatigue.
o Take a break for 10 to 15 minutes every hour to relax.
o Avoid spending more than 6 hours per day looking at the monitor screen.
Spillage
Malfunction due to spilled liquid

Any liquid spilled on the instrument may result in malfunction, or damage of the analyzer.
CAUTION o Do not place samples, reagents or any other liquid on the surface of the analyzer.
o If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be
sure to wear protective equipment.
Roche Diagnostics
Safety summary
Data security
Unauthorized access and data loss due to malicious software and hacker attacks
Portable storage media can be infected with and transmit computer malware, which may
CAUTION be used to gain unauthorized access to data or cause unwanted changes to software.
The cobas c 311 analyzer is not protected against malicious software and hacker attacks.
The customers are responsible for IT security of their IT infrastructure and for protecting it
against malicious software and hacker attacks. Failure to do so may result in data loss or
render the cobas c 311 analyzer unusable.
Roche recommends the following precautions:
o Allow connection to authorized external devices only.
o Ensure that all external devices are protected by appropriate security software.
o Ensure that access to all external devices is protected by appropriate security
equipment. Roche strongly recommends the use of a cobas IT Firewall.
o Do not copy or install any software on the cobas c 311 analyzer unless it is part of the
system software or you are instructed to do so by a Roche service representative.
o If additional software is required, contact your Technical support to ensure validation of
the software in question.
o Do not use the USB ports to connect other storage devices unless you are instructed to
do so by official user documentation or a Roche service representative.
o Exercise utmost care when using external storage devices such as USB flash drives,
CDs, or DVDs. Do not use them on public or home computers while connecting to the
cobas c 311 analyzer.
o Keep all external storage devices in a secure place and ensure that they can be
accessed by authorized persons only.
Roche Diagnostics
Safety summary
Notices
NOTICE List of notices

Before operating the analyzer, read the notices contained in this summary carefully. Failure
to observe them may result in damage to equipment.
Moving parts
NOTICE Damage to the analyzer due to contact with moving parts

Contact with moving parts may bend the probes or damage some other component. If the
analyzer detects a collision, an alarm will be issued and operation will be stopped
immediately.
o Keep all covers closed and in place while the instrument is operating.
o Do not touch any parts of the instrument other than those specified. Keep away from
moving parts during instrument operation.
o Only load samples onto the sample disk when the green Access Sample Disk lamp
next to the sample disk is on. This indicates that the sample disk will not rotate until
renewed operation is actively initiated by the operator.
Circuit breakers and fuses
NOTICE Damage to the analyzer due to improper use

Should one of the instrument circuit breakers or fuses blow, do not attempt to operate the
analyzer before contacting either your Roche service representative or technical support.
Roche Diagnostics
Safety labels of the system
Warning labels have been placed on the analyzer to draw your attention to areas of
potential hazard. The labels and their definitions are listed below according to their
location on the instrument.
The safety labels on the analyzer comply with the following standards: ANSI Z535,
IEC 61010, IEC 60417, or ISO 7000.
If the labels are damaged, they must be replaced by Roche service personnel. For
replacement labels, contact your local Roche representative.
Spillage warning
This label indicates that the instrument may be damaged if a spillage
occurs within the vicinity of this label.
Do not place liquids in this area.
Infection warning
This label indicates that touching the instrument mechanism can cause
infection or injury to your fingers or hands.
Do not open the top cover while the instrument is in operation. Stop every
mechanism, then open the top cover.
Protective equipment warning
This label indicates that there is a danger of coming into contact with
corrosive material within the vicinity of this label.
Wear appropriate protective equipment (such as goggles and gloves).
Warning
This label indicates that there is a danger of hazardous situations arising
within the vicinity of this label, which may result in death or serious injury.
Refer to the Operator's Manual for instructions on safe operation.
Biohazard warning
This label indicates that there are potential biohazards within the vicinity
of this label.
The relevant laboratory procedures on safe use must be observed.
Electrical warning
This label indicates that there is a danger of coming into contact with
electrical components when gaining access to parts of the analyzer marked
with this label.
Refer to the Operator's Manual for instructions on safe operation.
Hot surface warning
This label indicates that the area within the vicinity of this label may be
hot.
Do not touch this area as you may be burned.
Barcode label direction
This label indicates that the barcode label has to be on the right side when
inserting the cobas c pack or other cassette into the reagent compartment.
Do not turn the cobas c pack the other way around as severe malfunctions
may occur.
Roche Diagnostics
The following sections briefly describe the meaning of the safety labels in the context
of where they occur on the instrument.
e For detailed information about the safety labels on the instrument, see:
Front view on page A-16
Side view on page A-17
Top view on page A-18
Rear view on page A-19
In addition to safety labels on the instrument there are safety notes in the
corresponding parts of the Operator’s Manual and Online Help.
e For more information, see:
Part Operation on page B-1
Part Maintenance on page C-1
These safety notes give more detailed information about potentially hazardous
situations that may arise during daily operation or when carrying out maintenance
procedures.
When working with the analyzer, be sure to observe both the safety labels on the
instrument and the safety notes in the Operator’s Manual and Online Help.
Roche Diagnostics
Front view
F-1
F-1
F-2
F-2
F-3
F-3
F-4
F-4
F-5
F-5 F-6
F-4 F-7
F-5
Figure A-1 Front view of the analyzer
F-1 Warning: Possibility of infection or injury due to contact with

operating mechanisms!
Keep top cover closed whenever possible.
F-2 Warning: Fingers or skin may be pinched by syringe (when
plunger is moving).
Do not touch any moving parts.
Caution: Loose tube connector may lower measurement
precision.
After performing maintenance, tighten connector securely.
F-3 Warning: Possibility of infection due to contact with sipper
syringe!
Keep front cover closed during operation.
F-4 Caution: Detergent and/or reagent may cause skin irritation!
Observe safety precautions. Wear protective equipment.
F-5 Warning: Possibility of electrical shock inside the instrument.

Do not remove the cover!
Roche Diagnostics
F-6 Warning: Possibility of infection due to contact with waste from

the vacuum tank!
Follow standard laboratory practices for working with biohazardous
materials.
F-7 Caution: Malfunction due to spilled liquid
Follow all instructions for water tank maintenance carefully!
Side view
S-1
S-1
Figure A-2 Right side of the analyzer
S-1 Warning: Possibility of infection due to contact with waste

solution in waste solution tank!
materials.
Roche Diagnostics
Top view
T-1 T-2 T-3 T-4
T-5 T-6 T-7 T-8
Figure A-3 Top view of the analyzer
T-1 Warning: Possibility of burning yourself on the lamp or the lamp

housing when replacing the photometer lamp!
Wait until the lamp housing has cooled down.
T-2 Warning: Possibility of injury or infection due to contact with
moving mechanism!
Keep top cover closed whenever possible.
T-3 Caution: Touching the ISE Ref. tube during analysis may lower
measurement precision!
Do not touch ISE Ref. tube during analysis.
T-4 Incorrect results due to incorrect placement of reagent
Make sure the cobas c pack is facing in the right direction when
inserting cassettes!
T-5 Warning: Possibility of infection due to contact with parts of the

ISE measuring compartment!
materials.
T-6 Caution: Opening the cover of the ISE measuring compartment
may lower measurement precision!
Keep ISE cover closed during analysis.
Roche Diagnostics
T-7 Warning: Your fingers or hand may be pinched by the reagent

disk during operation!
Do not reach into the reagent disk during operation.
T-8 Spilled liquids, e.g. samples or detergents, may cause
instrument damage.
Wipe up spilled liquids immediately.
Rear view
R-1
R-1 R-2
R-2 R-3
R-3
Figure A-4 Rear view of the analyzer
R-1 Warning: Possibility of electrical shock.

Do not remove the cover!
R-2 Caution: Incorrect results due to loose tube sockets

Follow instructions for inlet water filter maintenance carefully!
R-3 Warning: Possibility of infection due to contact with ISE waste

solution!
materials.
Roche Diagnostics
Disposal of the analyzer
Disposal of the analyzer
Infection by a potentially biohazardous instrument

The instrument must be treated as potentially biohazardous waste. Decontamination (i.e., a
WARNING combination of processes including cleaning, disinfection and/or sterilization) is required
before reuse, recycling, or disposal of the instrument.
Dispose of the instrument according to the appropriate local regulations. For more
information, contact your Roche representative.
Disposal of control unit components

Components of your control unit (such as the computer, monitor, keyboard) which are
marked with this symbol are covered by the European Directive on Waste Electrical and
Electronic Equipment (WEEE, 2002/96/EC).
These items must be disposed of via designated collection facilities appointed by
government or local authorities.
For more information about disposal of your old product, please contact your city office,
waste disposal service or your Roche representative.
Constraint:
It is left to the responsible laboratory organization to determine whether control unit
components are contaminated or not. If contaminated, treat them in the same way as the
instrument.
Roche Diagnostics
cobas c 311 analyzer 2 Description of the analyzer
Table of contents
Description of the analyzer
This chapter provides a detailed description of the control unit, the sampling unit, the
components of the reaction disk and the reagent area as well as the ISE unit. The
sample containers and other system components are also described in this chapter.

Overview ......................................................................................................................... A-23
Areas and components of the analyzer ................................................................ A-24
Photometric unit ............................................................................................... A-24
ISE unit ............................................................................................................... A-25
Other Components ........................................................................................... A-25
Basic specifications and system characteristics .................................................. A-26
Power switches .............................................................................................................. A-27
Control unit ................................................................................................................... A-28
Computer ................................................................................................................. A-29
Touchscreen Monitor ............................................................................................. A-29
Keyboard .................................................................................................................. A-29
Mouse ....................................................................................................................... A-30
Printer ....................................................................................................................... A-30
System interface port .............................................................................................. A-30
cobas link ........................................................................................................................ A-31
Overview .................................................................................................................. A-31
Main functions ........................................................................................................ A-32
Working with cobas link functions ...................................................................... A-33
Using e-barcodes via download ...................................................................... A-33
Using the backup function .............................................................................. A-34
Using e-package inserts ................................................................................... A-34
Brief introduction to the cobas e-library ....................................................... A-34
Sampling area components .......................................................................................... A-37
Sample disk .............................................................................................................. A-38
STAT positions ................................................................................................. A-38
Sample detectors and barcode readers ........................................................... A-38
Sample pipetting system ........................................................................................ A-40
Sample pipetter ................................................................................................. A-40
Sample probe rinse station .............................................................................. A-40
Sample syringe .................................................................................................. A-41
Roche Diagnostics
2 Description of the analyzer cobas c 311 analyzer
Table of contents
Sample tubes and cups ........................................................................................... A-42

Categories of samples ....................................................................................... A-42
Sample containers ............................................................................................. A-42
Barcoded and non-barcoded samples ............................................................ A-43
Reagent area components ............................................................................................ A-44
Reagent compartment ............................................................................................ A-44
Reagent pipetting system ....................................................................................... A-45
Reagent pipetter ................................................................................................ A-45
Reagent probe rinse station ............................................................................. A-46
Reagent syringe ................................................................................................. A-46
Reagent management system ................................................................................ A-47
Reagent loading station .................................................................................... A-47
Barcode reader .................................................................................................. A-48
Piercer ................................................................................................................. A-48
Reaction disk area components .................................................................................. A-49
Reaction disk ........................................................................................................... A-49
Ultrasonic mixer ..................................................................................................... A-50
Reaction bath ........................................................................................................... A-51
Top cover ................................................................................................................. A-51
Photometer .............................................................................................................. A-52
Cell rinse unit .......................................................................................................... A-53
Flow of photometric analysis ................................................................................ A-55
Reaction monitoring .............................................................................................. A-58
ISE area components .................................................................................................... A-59
ISE sipper mechanism ............................................................................................ A-60
ISE measuring system ............................................................................................. A-61
ISE reagent compartments .................................................................................... A-61
Flow of an ISE analysis ........................................................................................... A-62
Behind the front doors ................................................................................................. A-64
Vacuum system ....................................................................................................... A-64
Water supply ............................................................................................................ A-64
Sound volume adjustment knob ........................................................................... A-65
Auxiliary reagents and cleaning solutions ........................................................... A-65
Rear view ........................................................................................................................ A-66
Roche Diagnostics
Overview
Overview
The Roche/Hitachi cobas c 311 analyzer is an automated, software-controlled system

for clinical chemistry analysis. It is designed for both quantitative and qualitative in
vitro determinations using a large variety of tests for analysis.
The cobas c 311 analyzer:
o performs photometric assays and ion-selective electrode measurements and
o uses serum/plasma, urine, CSF, and supernatant sample types.
It is ready for use 24 hours a day and well-suited for all small to medium workload
requirements.
Main components The main components of the cobas c 311 analyzer are:
o Analytical unit: performs the measurements.
o Control unit: controls and monitors the complete analytical process, saves and
outputs measurement results and supports maintenance functions.
A Analytical unit (analyzer) B Control unit
Figure A-5 The cobas c 311 analyzer
Roche Diagnostics
Overview
Areas and components of the analyzer
The analyzer comprises a photometric unit and an ISE unit (for ion-selective
electrode [ISE] determinations).
A
E
F
C
A Reaction disk area D ISE area

B Sampling area with the sample pipetter E Reagent pipetter
C Sample disk F Reagent loading area (for cobas c packs)
G Reagent compartment
Figure A-6 Areas of the cobas c 311 analyzer
Photometric unit
The photometric unit provides the analyzer with a flexible photometric method of
assaying up to 300 in vitro tests per hour on a wide range of analytes. The following
are the main components of the cobas c 311 analyzer:
o Sampling system
o Reagent system
o Reaction disk system
Sampling system The sampling system is composed of a sample disk, a sample pipetter (consisting of a
pipetter arm and the sample probe), a sample syringe, and a rinse station for internal
and external rinsing of the sample probe.
e See Sampling area components on page A-37.
Roche Diagnostics
Overview
Reagent system The reagent system is composed of a refrigerated reagent compartment consisting of
two storage rings for cobas c packs, and a reagent pipetting system. The reagent
pipetting system consists of a reagent pipetter (consisting of a pipetter arm and the
reagent probe), cap piercing device, a reagent syringe, and a rinse station for internal
and external rinsing of the reagent probe.
e See Reagent area components on page A-44.
Reaction disk system The reaction disk system is composed of a reaction disk, immersed in a reaction bath,
an ultrasonic mixing unit, a photometric measuring system, and a cell rinse unit for
cleaning the reaction cells once test measurement is complete.
e See Reaction disk area components on page A-49.
ISE unit
Moreover, the cobas c 311 analyzer has an integrated ISE unit, which provides the
system with a potentiometric method for assaying sodium, potassium and chloride
samples. The ISE unit can process up to 150 samples per hour. The following are the
main components of the ISE unit:
o ISE measuring compartment with measuring cartridges for Cl-, K+, Na+ and
Reference cartridge
o ISE sipper mechanism
o ISE reagent compartment
e See ISE area components on page A-59.
Other Components
Other components of the analyzer are the following:
o Water supply
o Vacuum system
o System interface port
o Waste solution container
Roche Diagnostics
Overview
Basic specifications and system characteristics
Figure A-7 Front view of the cobas c 311 analyzer
Basic specifications cobas c 311 analyzer
o Up to 300 photometric tests/h

o Up to 450 ISE tests/h (150 samples/h)
o 42 positions for cobas c packs (or COBAS INTEGRA cassettes)
100 applications:
o 86 photometric applications
o + 3 ISE applications + 3 serum indices + 8 calculated tests
Table A-1 Basic specifications of the cobas c 311 analyzer
System characteristics o Quick STAT sample processing

o Automated maintenance functions
o Automatic rerun capability
o Automatic calibration notification
o Automatic quality controls (Auto QC)
o Automatic sample dilution capabilities
o Non-contact ultrasonic mixing
o Reduced water consumption
o HbA1c whole blood support
e For detailed specifications of the analyzer, see:
Specifications on page A-69
Roche Diagnostics
Power switches
Power switches
There are two types of power switches: One power switch each for the analytical unit
and the control unit, and in addition the superordinate power switch (main circuit
breaker).
NOTICE Damage to the analyzer due to improper power connection

o The analyzer must only be connected to a power supply source with the specified
power supply cable and by trained personnel.
o Always make sure that the power switch is in the off position before plugging in the
analyzer.
A B C D
A Power switch of the analytical unit D Main circuit breaker of the analytical unit
B Maintenance switch
C Power switch of the control unit
Figure A-8 Power switches of the analyzer
Power switch Dependent components

Power switch of analytical unit Analytical unit except for cooling unit (at the right side),
used for powering on or shutting down the instrument
Maintenance switch Turns off the low voltage power to the pipetters, the
sample disk and the reaction disk, used for any actions
which require the top cover to be open while the analyzer
remains powered on
Power switch of control unit Personal computer
Main circuit breaker Whole analyzer including the cooling unit (at the rear
side), usually turned on for keeping the reagent cooling
unit active.
Table A-2 Power switches of the analytical unit and dependent components
Roche Diagnostics
Control unit
Correct order for switching on Please note that there is a prescribed order for switching on and off. The following
and off order must be observed:
o Warning: Do not switch on the analyzer unless you have been trained by Roche
and unless you are familiar with the safety precautions.
o For switching on, the analytical unit has to be switched on before the control unit.
o For switching off (shutdown), the control unit has to be switched off first by
choosing Shutdown from the software. After the computer power supply has
turned off, switch off power for the analytical unit, monitor and printer.
Control unit
The control unit uses a graphic user interface to control all instrument functions. The
following are components of the control unit:
A Touchscreen Monitor C Height adjusting lever

B Keyboard/Mouse D Computer
(the cobas link data station is not visible here)
Figure A-9 Control unit
NOTICE Damage to the analyzer due to magnetic fields

Keep the touchscreen, computer and any disks away from magnetic fields.
Components of the control unit are subject to change without prior notice.
Roche Diagnostics
Control unit
Computer
The computer monitors the functions and operational modes of the analyzer.
A hard disk drive is used to store system operating parameters as well as data from
patient samples, controls, and calibrators.
A 3 1/2 inch floppy disk drive and a DVD-RW rewrite device are available for reading
and writing parameters and other information for backup purposes. The DVD drive
is also used for installation of software.
Only Roche technical support may install software onto the analyzer.
e For a description of the analyzer software, see:

General description of the user interface on page B-7
Main menus on page B-11
Software elements on page B-17
Touchscreen Monitor
The system is equipped with a 15" color monitor with touchscreen adapter. The
monitor is used:
o To display information
o To navigate through the software
o To initiate instrument functions
Use your finger to touch what you want to request or change directly on the screen.
Most of the items within the software can be accessed using the touchscreen. Touch
the item desired (for example, menu bar, list box, text box, button, etc.) to complete
your task. For example, to display the Data Review screen in the Workplace menu,
touch Workplace, then the Data Review tab.
When touching the screen, be sure to “tap”, not “press”. The tap must be of short duration.
Selecting Items To select a consecutive range of items in a list, press the <Shift> key and touch the
first item in the range. While continuing to press the <Shift> key, touch the last item
in the range. All items, including the first and last items touched in the range, are
highlighted. You may also touch the first item in the list and drag your finger to the
last item in the list.
To select multiple, nonconsecutive items, press the <Ctrl> key, then touch the desired
items.
Height adjusting lever To adjust the height of the monitor base, lift the lever.
Keyboard
A 101-key enhanced keyboard is used to navigate through the software and to enter
information.
Most items that can be accessed by means of the touchscreen can also be accessed by
means of the keyboard.
e For more information, see Shortcut keys on page B-32
Roche Diagnostics
Control unit
Mouse
A mouse is available to navigate through the software.

The mouse can be used to select items on the screen and to place the cursor at an
insertion point in a text box. To select an item using the mouse, move the mouse over
the item and then click.
Printer
The system supports a graphics-capable printer. Patient results can be printed in

report format (long) or in monitor format (short). The printer can be ordered as an
optional accessory.
e See Report Format on page B-261.
Only Roche technical support may install and connect the printer.
System interface port
The following components take part in the data communication within the analyzer
and its network environment:
o Connected analyzer
o cobas link
o Host computer
There are two devices to accomplish the data communication: A serial port for
bidirectional communication with the Host computer and a hub for network
connections. The hub is located on the PC stand.
e See System interface on page A-77.
Incorrect results or damage to the analyzer due to wrong installation

o The connection between control unit and analytical unit must be done by Roche
CAUTION technical support only.
o Do not use connection cables other than the cables provided by Roche technical
support.
Roche Diagnostics
cobas link
cobas link
Overview
cobas link platform The cobas link platform is the gateway for retrieving and distributing information -
such as instructions for use, value sheets, important notes, and test- and lot-specific
analyzer settings - from Roche TeleService-Net to cobas analyzers in the laboratory.
cobas link is an integral and mandatory part of the cobas modular platform
analyzers.
TeleService-Net (TSN) TeleService-Net is the technical infrastructure to provide cobas analyzers and
operators with important product information from Roche. TeleService-Net offers
several applications to manage and display data and information of remotely
connected instruments.
TeleService-Net
cobas link
data station
cobas analyzers
Figure A-10 The cobas link platform
cobas link data station The cobas link data station is a dedicated desktop computer with keyboard, mouse,
monitor, and printer.
cobas e-library The cobas e-library (e-library) is the user interface for working with cobas link on the
cobas link data station.
The main application on cobas link for the operator is the cobas e-library, consisting
of e-package inserts and e-barcodes. This application is used for searching, reviewing,
and printing of e-package inserts.
There is a separate Operator’s Manual for the cobas e-library available.
e For more information on working with the e-library, refer to the cobas e-library
Operator’s Manual.
Roche Diagnostics
cobas link
cobas link update process cobas link receives data from TSN about the applications, calibrators, and controls
used on cobas analyzers. This ensures that the most up-to-date product information
is always available in the laboratory. All information relevant for the analyzer can be
downloaded from cobas link.
cobas link is updated daily via an automatic download if connected to the internet or
a phone line. The cobas link data station connects to TSN, typically overnight,
depending on the customer's requirements (configured by Roche service engineers
during installation). While connected, all newly available data are downloaded from
the TSN to your cobas link data station.
If your laboratory does not have an online connection to TSN, the TSN data is
provided on a CD, distributed by your local Roche organization.
e For more information on working with CD, refer to the cobas e-library Operator’s
Manual.
Main functions
From the operator’s point of view the main functions of cobas link are:
Analyzer control unit

Upload
backups
Download
e-barcodes
Provide
e-package inserts
cobas link data station
Figure A-11 cobas link - main functions
e-package inserts o The cobas e-library stores many documents (e-package inserts) such as the
instructions for use for the applications, information on controls, calibrators, and
announcements.
e See Using e-package inserts on page A-34
e-barcodes o Providing e-barcodes (e-BC) like application parameters to be downloaded from

cobas link to the analyzer by the operator. e-BCs are instrument readable only.
e See Using e-barcodes via download on page A-33
Backup function o Providing the possibility of important data backup for the cobas c 311 analyzer.
e See Using the backup function on page A-34
Roche Diagnostics
cobas link
Working with cobas link functions
This section explains the working principles of the main cobas link functions.
Using e-barcodes via download

The operator downloads the required e-barcodes from the cobas link data station to
the analyzer.
The following types of e-barcodes are available:
o Application data
o Calibrator data
o Control data
The following figure gives an overview of the installation process.
Figure A-12 Installation process of a new cobas application
If the data of a particular application (application parameters, calibrator data, and

control data) is not available on the analyzer, it has to be downloaded from
cobas link.
Loading or updating applications on page B-214
Reassigned calibrator or control values have to be downloaded manually!

If calibrator or control values for a particular calibrator or control have been reassigned,
you are informed by means of the cobas e-library. In this case, you must manually update
the calibrator and control data.
e For reassignment of calibrator or control values, see:
Reassignment of control values on page B-207
A detailed description for installing new applications, calibrators, and controls is

given in the corresponding chapters.
e For a more detailed description see:
To download application parameters from cobas link on page B-215
To download calibrator data from cobas link on page B-167
To download control data from cobas link on page B-203
Roche Diagnostics
cobas link
Using the backup function

Instrument and process related data can be stored to the hard disk of the cobas link
data station for disaster recovery. In order to initiate this backup function it is
necessary to include the cobas link Essential Information Upload function in a
maintenance pipe that is carried out daily (e.g., the Power On pipe).
This item can only be performed in a Maintenance Pipe.
e For more information, see
Defining and editing maintenance pipes on page C-11
Recommended maintenance pipes on page C-17
cobas link Essential Information Upload on page C-27
Perform daily backups to preserve the operational availability of the analyzer!

Include the cobas link Essential Information Upload function into a maintenance pipe that
is executed daily. If a hard disk error on the control unit occurs, the last backup can be
restored from the cobas link data station.
Using e-package inserts

You can view and print package inserts as required through the e-library. The
following electronic documents are provided via the e-library:
o e-package inserts (e-PI)
O Instructions for use
O Value sheets of calibrators and controls
O Important notices (for example reassigned control values)
O Announcements of the local Roche organizations
Check your cobas e-library daily to obtain important information!

It is important to check your cobas e-library daily because important information that is
necessary for analysis—like reassigned control values—is announced through the
cobas e-library.
Brief introduction to the cobas e-library

The following section explains how to start the e-library application and gives an
overview over the user interface.
a To start the e-library

1 Log on to the cobas link data station, by entering the user name and password for
the e-library.
2 Confirm with OK.
The start screen of the e-library is displayed (New Entries).
Roche Diagnostics
cobas link
Overview of the user interface The screen in Figure A-13 is for illustrative purposes only. It shows the New Entries
for an analyzer with clinical chemistry and immunological modules.
D
B
Figure A-13 Introduction to the cobas e-library user interface
The e-library user interface comprises the following components:
A Navigation bar has a tab for the e-library application. Links to other applications
can also appear in this bar. The e-library application opens by
default.
B Navigation menu provides links to the e-library application screens.
C Online Help accesses the context-sensitive online help. A quick and
convenient way to find information, such as explanations of
screens and dialog boxes and how to perform particular
processes.
D Screen header displays the path of your active screen. The active operator name
is displayed on the right hand side of the Screen header.
E Message List displays the list of bulletins, letters, package inserts, value sheets
and product announcements.
F Footer explains the icons used in the document and version columns.
Roche Diagnostics
cobas link
The e-library offers the following important functions:

o Show new e-library documents (New Entries screen), based on Preferences
Screen
o Search for documents in the e-library archive (Search screen)
o Specify applications, calibrators, and controls currently used on the system
(Preferences screen)
o Check the New Entries screen on a daily basis to make sure that you receive all
important information from Roche.
o Whenever you load a new application, make sure that you always add it to your
Preferences. Only the items you have selected in Preferences will be displayed on
the New Entries screen.
o If the cobas link data station is not connected to TeleService-Net, you have to update
regularly via CD (Update e-library screen).
e For more information on working with the e-library, refer to the cobas e-library
Operator’s Manual.
Roche Diagnostics
Sampling area components
The following components belong to the sampling area:

o A sample disk
o A sample pipetter (consisting of pipetter arm and probe) for pipetting samples
from the sample tubes to the reaction cells on the reaction disk
o A shield pipe that protects the sample probe against electrostatic noise
o The detergent bottles for the auxiliary reagents Sample Cleaner 1 and Sample
Cleaner 2
o A rinse station for internal and external rinsing of the sample probe
F
A
D
G
A Sample pipetter E Reaction disk

B Shield pipe (against electrostatic noise) F Rinse station with drying cylinder
C Sample probe detergent bottles: G Access Sample Disk lamp
1: Sample Cleaner 1 (SmpCln 1)
2: Sample Cleaner 2 (SmpCln 2)
D Sample disk
Figure A-14 Sampling area components
Roche Diagnostics
Sample disk
The sample disk is located at the front on the left side. The rotor consists of two
concentrical rings with a total number of 108 positions for samples.
It is possible to reserve some positions for STAT samples. In addition, the sample
disk can hold different sample types, QCs and calibrators. When working without
barcode the positions for auto QC and calibrators must be defined by means of the
software. The position W1 is reserved for tubes with ISE cleaning solution/SysClean
and the position W2 for ISE Activator.
For easier adding and removing of samples, the sample disk could be taken out of the
analyzer. Make sure that the shield pipe is lifted up first.
Personal injury due to touching moving parts

Only load samples onto the sample disk when the green Access Sample Disk lamp next to
CAUTION the sample disk is on. This indicates that the sample disk will not rotate until renewed
operation is actively initiated by the operator.
Access Sample Disk lamp The green Access Sample Disk lamp displays the following statuses:
Access lamp Sample disk ...

Green Can be accessed
Blinking Starts to rotate soon
OFF Must not be accessed
Table A-3 Statuses of the Access Sample Disk lamp
STAT positions
Use the STAT positions to start analysis of any samples directly, by-passing all
samples in the sample disk. The number of reserved positions for STAT samples is
definable (on the inner ring). A sample loaded in a STAT position will be processed
with higher priority than other samples on the sample disk.
Sample detectors and barcode readers

When samples are loaded onto the sample disk, they pass by a sample detector and a
barcode reader. A sample detector and a barcode reader are located on the inner and
outer sides of the sample disk area. They scan the inner and the outer ring of the
sample disk for the presence of samples and barcodes (see Figure A-15 on
page A-39).
Sample detector The sample detectors detect if there is a sample present in a sample position.
Roche Diagnostics
Barcode reader The barcode readers scan the barcode on each sample.
B
C
A Barcode reader (long slot) for outer ring C Barcode reader and sample detector for
B Sample detector (short slot) for outer ring inner ring
Figure A-15 Barcode readers and sample detectors in sample disk area
Barcode scan range The barcode label must be positioned so that it can be scanned through the opening
in the sample disk (see Figure A-16 on page A-39).
A
max. 88 mm
A Sample tube (100 mm) C Barcode scan range

B Opening for barcode scanning
Figure A-16 Sample tubes on the outer ring with their barcode facing outwards
e For specifications of the correct position of the barcode label, see:

Barcode specifications on page A-78
Ensure that the sample barcodes are facing the right way so the two barcode readers can
scan them. Samples placed in the inner ring must have their barcodes facing inwards,
samples placed in the outer ring must have their barcodes facing outwards.
Roche Diagnostics
Sample pipetting system
The sample pipetting system is composed of a sample pipetter and a sample syringe.
After each pipetting, the sample probe is rinsed by the sample probe rinse station.
A Sample pipetter C Tip water aspiration position

B Shield pipe D Sample probe rinse station
E Drying cylinder
Figure A-17 Sample pipetting system
Sample pipetter
The sample pipetter consists of the pipetter arm and the sample probe.
When a sample tube is in the sampling position, the barcode is read three times for
safety reasons. Then the pipetter transports sample liquid from a sample tube to a
reaction cell. When aspirating, liquid level detection (LLD) is accomplished by a
highly sensitive capacitance measurement, as well as a clot detection by means of
pressure measurements.
To protect the probe against electrostatic noise, which would interfere with the
capacitance measurement, a shield pipe is mounted over the sampling position.
After sample has been aspirated, the probe is raised from the sample and is moved to
the reaction disk. The sample probe arm lowers the probe into the reaction cell at the
sample dispense position. Sample is dispensed while the beveled sample probe tip is
in contact with the bottom of the reaction cell. This ensures that a precise volume of
sample is deposited into the bottom of the cell even when using a low dispense
volume. The sample probe is spring-mounted on the arm to avoid damage to the
probe or reaction cell.
Sample probe rinse station

The sample probe rinse station is located between the sample disk and the reaction
disk (see Figure A-17 on page A-40). To prevent carryover, the sample probe is
rinsed here with deionized water both externally and internally before aspirating
from a new sample. After rinsing, the sample probe is dried at the drying cylinder.
Roche Diagnostics
The rinse station is the home position for the sample probe when the pipetter is in
Standby.
In addition to the rinsing between pipetting, the sample probe is washed with Sample
Cleaner 1 and/or 2 from the sample probe detergent bottles:
o The daily and weekly maintenance actions include the washing of the sample
probe.
o Special washes can be programmed to prevent carryover.
Auxiliary reagents and cleaning solutions on page A-65
Daily maintenance on page C-46
Weekly maintenance on page C-58
Carryover evasion on page B-137
Sample syringe
The sample pipetter is connected by tubing to the sample syringe, which controls the
pipetting action.
A C
B
A Reagent syringe C ISE sipper syringe

B Sample syringe
Figure A-18 Position of the sample syringe (inside the left front door)
The sample syringe, which is located behind the left front door of the analyzer, is
filled with degassed and deionized water. The syringe uses positive displacement to
aspirate and dispense samples by means of the sample probes.
The syringe motor retracts the plunger within the chamber of the syringe, and sample
is aspirated into the tip of the sample probe. The pipetter arm moves the sample
probe to the reaction disk. The sample probe lowers into the reaction cell and the
syringe motor reverses to dispense the sample. The pipetter arm lifts the sample
probe from the reaction cell and moves it to the sample probe rinse station.
Roche Diagnostics
Sample tubes and cups
This section describes the different containers—sample tubes or cups—used to

supply samples to the analyzer.
Categories of samples
The cobas c 311 analyzer distinguishes the following categories of samples:
o Patient samples
O Routine samples
O STAT samples
O Rerun samples
o Calibrators
o Quality controls (QCs)
Sample containers
The following kinds of containers can be loaded onto the sample disk:
o Sample cups
O Hitachi standard cups
O Hitachi micro cups(a)
o Sample tubes (13 mm or 16 mm in diameter and 75 mm or 100 mm in length)
o In addition, non-standard tubes and false-bottom tubes can also be used.
G
H
A
B I
C J
D
E
F
A 13 mm x 100 mm tube F Hitachi standard cup

B 13 mm x 75 mm tube G Standard cup on 16 mm x 100 mm tube
C 16 mm x 100 mm tube H Micro cup on 16 mm x 100 mm tube
D 16 mm x 75 mm tube I Standard cup on 16 mm x 75 mm tube
E Hitachi micro cup J Micro cup on 16 mm x 75 mm tube
Figure A-19 Sample containers on sample disk
(a) Not applicable to calibrators and QCs
Roche Diagnostics
Sample cups can be inserted into 16-millimeter sample tubes (cup on tube) or they
can be used without tubes.
In this document, "container" is used as a generic term for all kinds of cups and tubes.
e For sample container specifications, see
Sample cups and tubes on page A-77
Barcoded and non-barcoded samples
Sample identification When operating in barcode mode, each sample’s barcode label is scanned by the
barcode reader of the sample disk. The sample barcode label provides the sample ID,
which is used for sample identification and test selection purposes.
e For specifications of barcodes and barcode labels, see
Barcode specifications on page A-78
Specifications of barcode labels on page A-79
The sample ID number provides tracking for the system. To track samples by means
of the software, select Sample Tracking from the System Overview screen.
When working with barcoded samples, only the STAT positions must be defined in
the software.
When working with Patient IDs, positions have to be assigned in the software for
routine and STAT samples for all sample types.
Non-barcode mode When operating in non-barcode mode, samples are identified by a sequence number
and their position in the sample disk. This assignment has to be done on the
Workplace > Test Selection screen.
When working with non-barcoded samples, define the position of each sample
category (controls, calibrators, and STAT positions) in the software.
Incorrect results due to sample mismatch

If samples are not placed in the proper position, incorrect measurement results may occur.
CAUTION When manually assigning positions, ensure the position is not already assigned.
Roche Diagnostics
Reagent area components
The following components belong to the reagent area:

o A refrigerated reagent compartment for storing up to 42 cobas c packs
o A reagent pipetter for aspirating reagents from the reagent compartment and
dispensing them to the reaction cells on the reaction disk
o A piercer for the cobas c packs
o A rinse station for internal and external rinsing of the reagent probe
o A reagent management system that controls the positions of the cobas c packs
within the reagent compartment
D
A
B
C
F
A Rinse station and drying cylinder D Cutouts for the reagent probe
B Piercer compartment E Reagent pipetter
C Reagent compartment (with cutout) F Gate to the reagent loading station
G Barcode reader
Figure A-20 Reagent area components
Reagent compartment
Reagents for photometric applications are stored in a closed, temperature-controlled

(5-15C) compartment containing two concentric rings with a total of 42 positions
for cobas c packs. There are 14 positions on the inner and 28 positions on the outer
ring.
To prevent reagents from evaporating, the reagent compartment is equipped with a
cover. By design, this cover is not meant to be opened or removed. The cobas c packs
are placed into and removed from the compartment by way of a gate (software-
controlled access).
Roche Diagnostics
Reagent pipetting system
The reagent pipetting system is composed of a reagent pipetter and a reagent syringe.
After each pipetting, the reagent probe is rinsed by the reagent probe rinse station.
B C D
A Reagent pipetter B Reagent probe rinse station

C Reagent probe drying cylinder
D Piercer compartment
Figure A-21 Reagent pipetting system (detail view)
Reagent pipetter
The reagent pipetter transports the reagents from the reagent compartment to the
reaction disk. The pipetter is mounted on an independent x-y-motion mechanism.
Before each pipetting, the reagent probe is externally and internally rinsed with
deionized water and dried. After reagent has been aspirated, the probe moves from
the reagent compartment to the reaction disk. There, the reagent volume is dispensed
into a reaction cell containing the sample. The mechanical cycle of the cobas c 311
analyzer allows for three different reagent timings: R1, R2, and R3.
The reagent probe is equipped with a pressure sensor and a liquid level detector
(LLD). When a new cobas c pack is loaded, the pressure sensor performs an initial
volume check—also referred to as initial cassette volume check (ICVC)—for each of
the bottles in a cobas c pack, if this option has been selected. The liquid level detector
is used for measuring the volume of the ISE reagents (ISE Dil. and ISE IS). Moreover,
the reagent pipetter picks up the piercer to open the cobas c pack by piercing the
tops.
e See Piercer on page A-48.
Roche Diagnostics
Reagent probe rinse station

The reagent probe rinse station is located between the reagent compartment and the
reaction disk. After reagent has been dispensed, the probe is always flushed internally
and externally with deionized water, and dried by the drying cylinder.
The rinse station is the home position for the reagent probe when the analyzer is in
Standby mode.
In addition to the rinsing between pipetting, the reagent probe is washed with
auxiliary reagents from cobas c packs:
o The weekly maintenance actions include the washing of the reagent probe.
o Special washes can be programmed to prevent carryover.
Auxiliary reagents and cleaning solutions on page A-65
Carryover evasion on page B-137
Reagent syringe
A C
B

B Sample syringe
Figure A-22 Position of the reagent syringe (inside the left front door)
The reagent syringe is located behind the left front door of the analyzer. It is filled
with degassed and deionized water, using positive displacement to aspirate and
dispense reagents.
Roche Diagnostics
Reagent management system
Reagents for all Roche applications are provided in cobas c packs (COBAS
INTEGRA cassettes can also be used). These cassettes contain from one to three
specially designed reagent bottles and have barcode labels with detailed reagent and
test-related information.
The following components belong to the reagent management system:
o Reagent disk (inside the reagent compartment)
o Reagent loading station
o Barcode reader
o Piercer
Reagent loading station

Use the reagent loading station to load and unload cobas c packs. Both processes
have to be started by means of the software (see Loading cobas c packs on page B-55).
After clicking the Loading button, the analyzer turns the reagent disk to a free
position. The reagent loading station is designed in such a way that a cobas c pack
can be loaded to only one position on the reagent disk. This rules out any possibility
of placing a cassette in a wrong position on the reagent disk or using inappropriate
reagents.
A Gate to the reagent loading station B Barcode reader

C Barcode label
Figure A-23 Scanning the barcode label on a cobas c pack
Incorrect results due to incorrect placement of reagent

If a cobas c pack (or COBAS INTEGRA cassette) is inserted the wrong way around,
CAUTION reagents will be pipetted in the wrong order, leading to incorrect results. The instrument
may also be damaged.
When inserting the cobas c pack, make sure the barcode is facing the barcode reader.
Roche Diagnostics
Barcode reader
The barcode reader scans data from the barcode label on the cobas c pack and checks
its integrity.
e For more information about the encoded data on the barcode label, see
Barcode label on page B-134.
After opening the gate of the reagent loading station, the operator scans the barcode
label and places the cobas c pack into the free position.
If the barcode of a cobas c pack or other cassette is unreadable, this cassette is not
accepted. The operator is requested to close the gate.
If the cobas c pack currently being scanned has not been on the analyzer before, the
analyzer registers the initial capacity, pierces the caps of the bottles and performs an
initial cassette volume check (ICVC)—if this option has been selected.
e For more information about the registration of cobas c packs, see
Reagent registration on page B-136.
Piercer
When a new cobas c pack is loaded into the reagent compartment, the reagent
pipetter picks up the piercer, which is kept near the rinse station. The piercer lowers
and pierces the caps of the reagent bottles in the cassette through the cutouts in the
compartment cover.
Roche Diagnostics
Reaction disk area components
The following components belong to the reaction disk area:

o A reaction disk with the reaction cells, which are immersed in the reaction bath
o An ultrasonic mixing unit for non-contact mixing of reaction mixtures (15 levels)
o A photometric measuring system that continually measures the absorbance of the
reaction mixture in each of the reaction cells
o A cell rinse unit for cleaning the reaction cells once test measurement is complete
E
A
F
B
G
C
A Photometer detector (hidden) E Reaction bath overflow

B Reaction cell rinse unit F One segment of 11 reaction cells
C Reaction disk G Cell covers
D Water level sensor H Ultrasonic mixing unit
Figure A-24 Reaction disk area
Reaction disk
The reaction disk of the cobas c 311 analyzer carries 66 semi-disposable plastic
reaction cells (cuvettes). These reaction cells are grouped together in six segments
with 11 cells each. All reaction cells are seated in a controlled-temperature bath. This
reaction bath maintains the cells at the required temperature of 37  0.1C. Therefore
it is also referred to as the incubator bath.
Cell covers Two cell covers protect the contents of the reaction cells from light. Some reactions
are light sensitive and intrusion of light could lead to faulty measurements. The cell
covers also serve to prevent contamination by reagents.
Roche Diagnostics
We recommend replacing the reaction cells once a month as they gradually deteriorate
over a prolonged period of use. Always carry out wash reaction parts and cell blank
measurement after replacing the reaction cells.
e See M8: Replacing reaction cells and cleaning incubator bath and drain filter on page C-68
C
F
A Reaction disk D One segment of 11 reaction cells

B Water level sensor E Reaction bath overflow
C Photometer lamp unit F Reaction bath (incubator bath)
Figure A-25 Reaction disk
Ultrasonic mixer
The ultrasonic mixing unit mixes the reagents within each of the reaction cells to
ensure a homogeneous distribution of reactants.
To avoid spillage, the water level of the incubator bath is checked before mixing by
calculating the volume. If the liquid level is too low or too high, an alarm (Mix.E) is
issued and mixing is not performed.
Contamination of the polished surface of the ultrasonic mixing unit will cause
inadequate mixing. It must be cleaned at least once every three months. The
ultrasonic output intensity is continually monitored. If the intensity falls below a
certain limit, an alarm (<Mix) is issued, and replacement of the ultrasonic mixing
unit is required. Contact your service representative for the replacement.
e See M15: Cleaning the ultrasonic mixer on page C-93.
Roche Diagnostics
Reaction bath
The circular reaction bath, positioned beneath the reaction disk, maintains the
reaction mixtures in the reaction cells at a temperature of 37C. Water in the reaction
bath is circulated by a pump through a refrigeration unit where it is cooled and then
onto the heater where it is heated, as necessary, to maintain the temperature
( 0.1C).
Two glass windows (inner and outer) are positioned in opposite walls of the reaction
bath. These windows permit light from the photometer lamp to pass through the
reaction bath water and through the reaction cells in the bath. The light beam
emerges from the outer window of the reaction bath and enters the instrument
photometer.
A liquid level sensor detects the water level of the bath. Deionized water is
automatically added to the reaction bath, as determined by the liquid level sensor, to
compensate for evaporation. This occurs even in Standby mode.
Hitergent Hitergent is a non-ionic, bacteriostatic detergent automatically added to the reaction

bath by the reagent pipetter whenever the water is exchanged. It acts as a surfactant to
minimize the formation of bubbles that could potentially interfere with the
photometer readings. Hitergent for the reaction bath is supplied in a cobas c pack.
Top cover
The reaction disk area (as well as most of the sampling area and the reagent area) is
covered by the top cover.
Injury to fingers by top cover dropping suddenly

Be careful when opening or closing the top cover. If you let go of the handle, the top cover
WARNING may drop onto your fingers.
o Always keep a firm grip on the handle and do not let go when opening or closing the
top cover.
o If the top cover does not stay open properly, please contact your local Roche service
representative.
The top cover protects the operator from:

o injury due to contact with the moving parts
o the risk of infection through contact with splashed sample material or through
inhaling reaction solution aerosol.
Therefore, always keep the top cover closed during operation. Before opening the
cover, make sure that the analyzer is in Maintenance mode or Shutdown status first.
e For information about instrument statuses, see:
Instrument statuses on page B-40.
Roche Diagnostics
Photometer
The cobas c 311 analyzer is equipped with a photometer to measure the absorbencies
of the reaction mixtures in the reaction cells.
The photometer lamp is located against the inner ring of the incubator bath beneath
the reaction disk. The detector is outside the incubator bath ring, near the cell rinse
unit.
e To locate the photometer detector, see Figure A-24 on page A-49.
Measurements are taken of all the 66 reaction cells, as the reaction disk is turning.
A B C D E F G H I J K L M
A Grating F Reaction cell and contents K Infrared cut filter

B Photometer G Incubator bath L Water jacket
C Slit H Slit (in) M Photometer lamp
D Imaging lens I Condenser lens N Detector
E Slit (out) J Mask
Figure A-26 Illustration of light path through photometer components
Photometer lamp The photometer lamp beneath the reaction disk, is encased in a constant-temperature
water jacket, which helps to maintain a constant energy output from the lamp, and
also extends the lamp life. Replace the photometer lamp if the photometer check
value at 340 nm exceeds 14000, or if lamp has been used for 750 hours or more.
e See M21: Replacing the photometer lamp on page C-113.
Light path The light from the photometer lamp passes through the following main components:
o Inner reaction bath window
o Reaction bath water
o Reaction cell and its contents
o Reaction bath water
o Outer reaction bath window
o ...and into the photometer
When the light beam enters the photometer, it strikes a diffraction grating. This
separates the light into its constituent wavelengths and reflects them onto a fixed
array of 12 photodiodes. Each photodiode is permanently positioned to detect light at
a different wavelength.
Roche Diagnostics
The computer uses the available assay parameter information to select the
wavelengths and the times at which a reaction mixture’s absorbance is read and
results calculated.
The instrument computer keeps track of which test is being performed in each
reaction cell. It also knows when each reaction cell passes through the photometer
light path. The computer uses this tracking ability and the programmed read
instructions to obtain test results.
Cell rinse unit
A Cell rinse unit B Cell rinse nozzles

C Reaction disk
Figure A-27 Reaction cell rinsing system
The cell rinse unit is located to the left of the reaction disk. It cleans, rinses, and dries
the reaction cells once the chemical reaction of the reaction mixture has been
measured. To ensure cell integrity (optical characteristics), a photometric reading of
a cell containing water is performed during the cleaning process (cell blank) and
compared with the stored value from the weekly cell blank measurement.
e For information about the used rinsing reagents, see
Auxiliary reagents and cleaning solutions on page A-65.
Roche Diagnostics
Cell rinse sequence The following sequence reflects the order in which cleaning, rinsing, and cell
blanking of the reaction cells takes place.
1. A: Liquid aspiration at end of reaction 5. I: Rinse water aspiration

B: Rinse water dispense J: Rinse water dispense
2. C: Rinse water aspiration 6. K: Rinse water aspiration (nozzle tip)
D: Detergent 1 dispense (CellCln I) 7. L: Water blank dispense
3. E: Detergent 1 aspiration M: Cell blank measurement (3 x)
F: Detergent 2 dispense (CellCln II)(a) 8. N: Water blank aspiration (nozzle tip)
4. G: Detergent 2 aspiration O: Water blank aspiration (nozzle tip)
H: Rinse water dispense
Figure A-28 Flow of the cell rinse mechanism
(a) CellCln II (acid wash) is only used if application requires.
Roche Diagnostics
Flow of photometric analysis
The following figures and descriptions help to understand the flow of photometric
analysis:
o Figure A-29 on page A-55 shows the main functions and their positions on the
reaction disk area.
o Figure A-30 on page A-56 shows the main steps of photometric analysis flow.
o Table A-4 on page A-57 explains the operating principle and the photometric
analysis flow.
A Sampling (diluted sample) E Reagent adding

B Sampling F Aspirating diluted sample and internal
C Cell rinse nozzles standard solution for ISE
D Photometer G Mixing
Figure A-29 Main functions and their positions on the reaction disk area
Roche Diagnostics
1 Start
2 Resetting
3 Rinsing of reaction cell
4 Measurement of water blank (cell blank measurement)
5 Aspiration of water
6 Sampling
7 Addition of R1, mixing

Reaction time No. of measurements per
(minutes): reaction cell:
8 Addition of R2, mixing
3 14
4 19
9 Addition of R3, mixing 5 24
6 28
7 33
8 43
9 52
10 57
10 Completion of all measurements
11 Rinsing of reaction cell
12 Automatic stop
Figure A-30 Flow chart of the photometric analysis
Roche Diagnostics
Step Action
1–2 Upon start, the instrument resets the mechanisms, and then starts rinsing the
reaction cell.
In a single cycle (12 s), the reaction disk rotates by 65 reaction cells, divided into six
steps with temporary stops. The rotation steps are: +17  +24  +17  -12 
+2  +17 reaction cells (+: forward, -: backward rotation, : temporary stop).
3 o Using the cell rinse nozzles A/B/C in the rinsing mechanism, reaction solution
is aspirated and the reaction cell is rinsed with deionized water.
o In the next 2 cycles, the reaction cell is washed with cell detergent 1 dispensed
from the cell rinse nozzle D and aspirated from nozzle E.
o In the next 2 cycles, the reaction cell is washed with cell detergent 2 dispensed
from the cell rinse nozzle F and aspirated from nozzle G.
o Deionized water is dispensed with nozzle H, it is aspirated with nozzle I.
o Using the nozzles J/K, the reaction cell is rinsed once again with deionized
water.
Note: The numbers of the cell rinse nozzles refer to Figure A-28 on page A-54.
4 Then a cell blank measurement is performed 3 times (M) after dispensing deionized
water with cell rinse nozzle L.
If the cell blank value differs by 0.1Abs or more from the stored value from the
weekly cell blank measurement, that cell will not be used for analysis.
5–6 When the reaction cell after rinsing and cell blank measurement advances to the
sampling position, sampling begins.
Sampling is carried out in the order starting from the sample that will take the
longest reaction time in order to shorten the time needed for completion of data
output.
7–9 Reagents R1, R2, and R3 are usable, and will be added at the determined time points
(0, 1.5 and 5 minutes).
After one of the reagents R1, R2, and R3 has been added, the liquid in the reaction
cell will be mixed at the mixing position by means of the ultrasonic mixer.
10 Sampling is carried out every 12 s (1 cycle), and measurement is performed once in
one full turn, that is 57 times in 10 minutes. On completion of measurement, the
concentration is calculated by use of the absorbance at the specified photometric
point.
11 The instrument dispenses the reaction solution with the rinsing mechanism and
conducts washing with cell detergents and rinsing with water.
12 Then the instrument goes into Standby.
Table A-4 Schedule of the photometric analysis
Roche Diagnostics
Reaction monitoring
The reaction disk rotates one turn in 12 seconds and during this time, the absorbance
is measured and stored for all of the reaction cells that cross the optical path of the
photometer. These absorbance values are recorded in the reaction monitoring
system. For each reaction cell, cell blank (absorbance 0) is measured, and then
photometry is performed 57 times in 10 minutes. Therefore, photometry is less
affected by time lapse. Also, the concentration can be calculated by using desired
photometric points.
Absorbance
G
E
24 57
BC
7
A
1
H
F
D
0 5 10
Time / min.
A Cell blank measurement E Addition of reagent 2 (R2)

B Addition of sample F Mixing of reagent 2
C Addition of reagent 1 (R1) G Addition of reagent 3 (R3)
D Mixing of reagent 1 H Mixing of reagent 3
Figure A-31 Example of a reaction course
Roche Diagnostics
ISE area components
ISE area components
The ISE unit provides an electronic method for measuring sodium, potassium, and
chloride ion activities in samples. It is designed to process up to 150 samples per hour
(450 tests/h).
The following components belong to the ISE unit:
o ISE sipper mechanism—for aspirating ISE IS and diluted sample from reaction
cells into the measuring system
o ISE measuring compartment
o Two ISE reagent compartments —containing bottles for ISE IS, ISE Dil., and
ISE Ref. (KCL)
The ISE analysis uses the reagent pipetter for pipetting ISE IS and ISE Dil. into
reaction cells.
A
D
E
B
A ISE sipper (beneath sipper cover) D Reagent pipetter

B ISE measuring compartment E ISE reagent compartment for ISE IS bottle
C ISE reagent compartment for ISE Dil. bottle F ISE reagent compartment for ISE Ref. bottle
Figure A-32 ISE area
Roche Diagnostics
ISE area components
ISE sipper mechanism
The ISE sipper mechanism consists of a sipper nozzle and a sipper syringe.
D
A
A ISE sipper nozzle B ISE reference cartridge

C Pinch valve
D ISE measurement cartridges
Figure A-33 ISE sipper and ISE measuring system (covers removed)
Sipper nozzle The sipper nozzle aspirates either ISE IS solution or sample solution diluted with
diluent from a reaction cell into the ISE measuring flow path. The ISE IS solution and
the sample with the diluent are heated up to the measuring temperature (37C) in the
reaction bath.
The sipper nozzle is cleaned during daily maintenance.
Sipper syringe The sipper syringe is positioned behind the left front door of the cobas c 311
analyzer. It is the rightmost syringe (to the right of the sample syringe). The syringe
not only provides the negative pressure for the sipper, it also aspirates ISE Ref. from
its container and into the reference cartridge flow path when the pinch valve is
closed.
Roche Diagnostics
ISE area components
ISE measuring system
The ISE measuring system is contained in a temperature-controlled compartment

(37 C). It is composed of three separate sample/ISE IS measurement cartridges and
one reference cartridge.
Measurement cartridges Three cartridges, each containing an ion-selective electrode, are directly connected to
form a flow path for the diluted sample and the ISE IS solutions.
Reference cartridge The reference cartridge contains the reference electrode. ISE Ref. is aspirated through
a separate flow path by the sipper syringe. A reference electrode potential is
registered.
Colors of the cartridges The electrode potentials are measured in the color-coded cartridges as follows:
1 Green Chloride Cl-

2 Red Potassium K+
3 Yellow Sodium Na+
Light blue Reference electrode
The difference between the potentials at the reference electrode and the ion-selective
electrode equals the electromotive force (EMF). For every test, the EMF of both
ISE IS and diluted sample solution are measured for each sort of ions (Cl-, K+, and
Na+). From these EMF values the results are calculated.
ISE reagent compartments
The two ISE reagent compartments contain three reagent bottles: Internal standard
(ISE IS), diluent (ISE Dil.) and reference solution (ISE Ref.).
e To locate the ISE reagent bottles, see ISE area on page A-59 (E and F).
The front reagent compartment contains a ISE Ref. (KCl) bottle. The sipper syringe
aspirates ISE Ref. to reference electrode when the pinch valve of the ISE measuring
system is closed.
The rear reagent compartment for ISE IS and ISE Dil. is equipped with level sensors
for each reagent bottle.
Roche Diagnostics
ISE area components
Flow of an ISE analysis
It usually takes three cycles to complete one ISE measurement, since internal
standard (ISE IS) is measured before and after sample. However, if only ISE is
continuously measured, two cycles are sufficient for one measurement, since the
ISE IS measured after sample can be used in common with the ISE IS to be measured
before the following sample. The final ISE measurement always requires three cycles.
In case of continuous ISE measurements In case of measurement of ISE and

(two cycles) photometric assay (three cycles)
ISE IS ISE IS
Meas. 1
Meas. 1
Sample and diluent Sample and diluent
ISE IS ISE IS
Meas. 2
Sample and diluent Photometric assay test

ISE IS ISE IS
Meas. 2
Sample and diluent
ISE IS
Table A-5 ISE measurement sequence
For every measurement, the analyzer measures three electromotive force values
(EMF); for chloride, potassium, and sodium, where EMF denotes the difference in
potential between the respective ion-selective electrode and reference electrode.
Roche Diagnostics
ISE area components
Finally, the results are calculated from the electromotive forces of ISE IS and diluted
sample. Table A-6 on page A-63 summarizes the flow of an ISE analysis:
Step Actor Action

Preparation of measurement
1 Reagent pipetter Pipettes ISE IS to reaction cell (450 L(a))
2 Ultrasonic mixing unit Mixes ISE IS
3 Sample pipetter Pipettes sample (9.7 L) to a second cell
4 Reagent pipetter Pipettes diluent (291 L(a)) to cell containing the
sample
5 Ultrasonic mixing unit Mixes sample and diluent
6 Reagent pipetter Pipettes ISE IS to a third cell (450 L(a))
7 Ultrasonic mixing unit Mixes ISE IS
Internal standard (ISE IS) measurement
8 Sipper nozzle Aspirates ISE IS to Cl/K/Na cartridges (400 L)
9 Sipper syringe Aspirates ISE Ref. to reference cartridge (65 L)
10 Electrodes Measure ISE IS
Diluted sample measurement
11 Sipper nozzle Aspirates diluted sample to Cl/K/Na cartridges (250 L)
13 Electrodes Measure sample
If there are more samples to be analyzed, go to step 3.
Internal standard (ISE IS) measurement
14 Sipper nozzle Aspirates ISE IS to Cl/K/Na cartridges (400 L)
16 Electrodes Measure ISE IS
17 Automatic stop
Table A-6 Flow of ISE analysis
(a) For detailed information about the pipetted ISE reagent volumes, see ISE unit on page A-76.
Roche Diagnostics
Behind the front doors
The following figure provides a front view of the cobas c 311 analyzer. The legend
lists the main components behind the front doors of the analyzer.
F
A
B
C
G
D
H
E
A Reagent syringe F Sound volume adjustment knob

B Sample syringe G Water supply tank (deionized water)
C ISE sipper syringe H Drain tube of the vacuum tank
D CellCln I / NaOH-D I Cooling unit (with radiator filter)
E CellCln II / Acid Wash
Figure A-34 cobas c 311 analyzer with open front doors
Vacuum system
The vacuum system is located at the front of the analyzer. It consists of a vacuum
pump, a vacuum tank, vacuum sensors, and connecting tubing. The vacuum system
aspirates reaction mixture waste from the reaction cells to the reaction waste
container and removes reaction cell rinse water from the analyzer through the main
drain line.
Water supply
The deionized water supply system consists of the water tank, located behind the left
front door, connecting tubing, and a series of electronic valves. Water is
automatically added to the water tank when necessary. Water from this source is
supplied directly to the cell rinse unit, to the rinse stations, and to the incubator bath.
Water for the cobas c 311 analyzer is to be deionized to a conductivity of 1 S/cm or
less. Deionized water will be consumed in about 12 L/h on average. The supply of
deionized water must have a capacity of 40 L/h or more.
Roche Diagnostics
Sound volume adjustment knob
The sound volume adjustment knob allows adjustment of the sound volume level of
the alarm buzzer.
Auxiliary reagents and cleaning solutions
o Two bottles with detergents for the cell rinse process are located behind the left
front door of the analyzer:
O Cell Wash Solution I / NaOH-D (CellCln I)
O Cell Wash Solution II / Acid Wash (CellCln II)
To replace a cell detergent bottle on page B-141
To locate the bottles, see Figure A-34 on page A-64 (D and E).
o Two small detergent bottles (70 mL) are located close to the sample pipetter. They
are used for cleaning the sample probe.
O Position 1: Sample Cleaner 1
O Position 2: Sample Cleaner 2
To replace a sample probe detergent bottle on page B-142
To locate the bottles, see Figure A-14 on page A-37 (C).
o Three detergents are supplied in cobas c packs:
O NaOH-D/Basic Wash for reagent probe cleaning
O SMS/Acid Wash for reagent probe cleaning
O SCCS detergent (Special Cell Cleaning Solution)
o Hitergent is supplied in a cobas c pack. Hitergent is an additive to the reaction
bath to reduce surface tension and algal proliferation.
e For more information about those reagents, see:
Auxiliary reagents and detergents on page B-132
cobas c packs on page B-133.
Roche Diagnostics
Rear view
Rear view
The Figure A-35 provides a rear view of the cobas c 311 analyzer. The legend lists the
main components on the back of the analyzer.
F
A
G
B
H
D I
A Cooling fan F Water supply tube for deionized water

B Power supply outlets (US only, behind cover) G ISE drain port
C Ethernet connector H Dilute waste line
D Mains connection I Waste solution container for highly
E Main circuit breaker concentrated waste
J Tray for condensation water
Figure A-35 Rear view of cobas c 311 analyzer
Power supply (US only) There are two outlets (100 V AC, 5 A) inside the cover. One is for the PC (control
unit), and the other is for the monitor only. Use these only if the power cord is too
short to reach an external power source.
The connection of PC or monitor to outlets must be done by Roche technical support only.
Ethernet connector The Ethernet connector is used for communication between the analytical unit and
the control unit.
The supplied Ethernet cable must be used. Only trained Roche technical support personnel
(or similarly qualified personnel supervised by authorized service agents of Roche
Diagnostics GmbH) are qualified to connect the Ethernet cable.
Main circuit breaker The main circuit breaker is usually turned on for keeping the reagent cooling unit
active.
e See Power switches on page A-27.
Do not place any obstacles in front of the main circuit breaker. You must have
unobstructed access at all times so that you can immediately turn off the power in case of
emergency.
Roche Diagnostics
Rear view
ISE drain port and waste The ISE drain port is used for discharging highly concentrated waste solution from
solution container the ISE unit into the waste solution container.
The waste solution container also contains the highly concentrated waste from the
reaction cells and is equipped with a liquid level sensor for issuing an alarm when it
becomes full.
Dilute waste line This line is used for discharging dilute waste solution.
Roche Diagnostics
Rear view
Roche Diagnostics
cobas c 311 analyzer 3 Specifications
Table of contents
Specifications
This chapter gives an overview of the specifications of the cobas c 311 analyzer.

System specifications .................................................................................................... A-71
Dimensions .............................................................................................................. A-71
Operating conditions .............................................................................................. A-71
Environmental conditions ..................................................................................... A-72
Control unit ................................................................................................................... A-73
Analytical unit ............................................................................................................... A-74
Reaction system ....................................................................................................... A-74
Sampling system ...................................................................................................... A-74
Reagent system ........................................................................................................ A-75
Photometric unit ..................................................................................................... A-75
ISE unit ..................................................................................................................... A-76
Other specifications ...................................................................................................... A-77
System interface ...................................................................................................... A-77
Sample cups and tubes ........................................................................................... A-77
Barcode specifications ............................................................................................ A-78
Roche Diagnostics
3 Specifications cobas c 311 analyzer
Table of contents
Roche Diagnostics
System specifications
The following specifications apply to the cobas c 311 analyzer.
Dimensions
Dimension International (Europe) US

Depth Total 859 mm 33.8 in
Height cobas c 311 analyzer 1260 mm 49.6 in
Top height level of the monitor 1380-1570 mm 54.3-61.8 in
is adjustable approx. between
Length Total 1325 mm 52.2 in
Weight Analytical unit about 250 kg 551 lb
Control unit about 20 kg 44 lb
Table A-7 Dimensions of the cobas c 311 analyzer
Operating conditions
The power distribution panel and the water supply and drainage facilities must be
available within 5 m of the analyzer.
Electric power supply Power rating Single phase/230 V AC/50 Hz (international/Europe) or

208 V AC/60 Hz (US/Canada)
Power supply fluctuation No significant power supply fluctuation (operating on
208/230 V AC, max. power supply change:  10 %)
Overvoltage category II
Pollution degree 2
Power consumption 1.5 kVA for analytical unit, 0.5 kVA for control unit
Electrical installation Technical standard class C
Required earthing < 10 
Bonding impedance < 0.1  at 30 A
Insulation resistance >10 M at 500 V

o The power supply must be grounded.
WARNING o The analyzer must only be connected to a power supply source with the specified
power supply cable and only by authorized personnel.
Incorrect results due to improper grounding of the electrical installations within a

building
CAUTION If grounding is poor, external noise will have a greater influence on the instrument.
o Comply with the specifications for electrical installation.
Roche Diagnostics
Water requirements Bacteria-free, deionized water < 10 cfu/mL

Conductivity 1.0 S/cm or less (1.5 M resistance)
Water pressure 50-340 kPa (0.5-3.4 kg/cm2)
Water consumption 12 L/h during operation
Required water supply 40 L/h
Environmental conditions
The following environmental conditions must be followed in order to ensure correct

operation of the analyzer:
Ambient temperature During operation:

o 15 to 32C (59.0-89.6F)
with changes <  2C ( 3.6F) during analysis
During transportation and storage:
o -20 to 75C (-4 to 167F)
Ambient humidity During operation:
o 30-85% (non-condensing)
During transportation and storage:
o 5-95%
Altitude up to 2000 m
Electromagnetic interference o No equipment generating electromagnetic waves in
the near vicinity (e.g., cell phones, transceivers,
cordless phones, etc.)
o No machines discharging ultrahigh frequencies (e.g.,
electric discharger)
Noise emission < 65 dB(A) to surrounding areas
Other environmental conditions o Dust-free environment with adequate ventilation
o No direct sunlight
o No perceptible vibration
o Indoor use only
Floor condition Level (angle: less than 1/200); strong enough to hold the
weight of the instrument, see Dimensions on page A-71.
Roche Diagnostics
Control unit
Control unit
The following specifications apply to the control unit of the cobas c 311 analyzer.
PC Supplied by Roche/Hitachi according to instrument

requirements
DVD drive 4.7 GB capacity
Applicable data media DVD-R, DVD+R, DVD-RW,
DVD+RW
e See Preparing a DVD disk on page B-122
Monitor 15"TFT color monitor with touch screen system
Keyboard 101-key enhanced, country-specific
Monitor and keyboard base Height adjustable
Data storage Sample data (routine/STAT) 10 000 samples (routine, STAT and quality control
samples)
Reaction process data 10 000 tests (routine, STAT and quality control samples)
Quality control data Individual: 2500 samples, 100 tests/sample
Cumulative: 100 tests, 500 points/test
Roche Diagnostics
Analytical unit
Analytical unit
The following specifications apply to the analytical unit of the cobas c 311 analyzer.
Reaction system
Applications Up to 100 applications:

o 86 photometric applications
o 3 electrolyte applications
o 8 calculated tests
o 3 serum indices
Number of cobas c packs Up to 42
on board
Throughput Up to 300 tests/h
Reaction volume 100-250 L
Reaction temperature 37  0.1C circulating incubator bath
Reaction disk Turntable system with 66 reaction cells
Reaction cells 6 segments of 11 reaction cells each (semi-disposable
cuvettes for photometry)
Reaction times 3-10 min, in 1-minute steps
Pipetting cycle 12 s
System start-up time 6 min (power on to standby)(a)
Mixing method Non-contact ultrasonic mixing (15 levels)
(a) If no Power Up Pipe function has been programmed to occur.
Processing capacity varies depending on measuring conditions, test selection and system
configuration.
Sampling system
Sample types Serum/plasma, urine, CSF, supernatant, other

Sample pipetting volume 1.0-35 L, in 0.1 L increments
1.0-1.9 L – water extrusion (15 L)
2.0-35 L – sample dummy (10 L)
20.1-35 L – two cycles used (24 s)
Detection of sample clogging Pressure sensitive clot detection system
Liquid level sensor Capacitance sensing technology
e For information about the minimum sample volume, see:

Sample cups and tubes on page A-77
Roche Diagnostics
Analytical unit
Reagent system
Reagent identification Barcode identification, manual placement

Reagent pipetting volume 5-180 L, in 1 L increments (5-19 L: + 20 L water)
Reagent pipetting timing 3 timings possible (R1: 0 min; R2: 1.5 min; R3: 5 min)
Reagent storage Refrigerated compartment for up to 42 cobas c packs
Reagents 4 different configurations available with up to 3 reagent
bottles/cassette:
o cobas c packs: bottles of 20 mL, 40 mL, or 60 mL:
(20/40/20 mL, 40/40 mL, 60/20 mL)
o COBAS INTEGRA cassette: Pos. A: 22.6 mL, Pos. B/C:
11.0 mL
Reagent cooling 5-15C
Remaining reagent volume Automatic test countdown with each pipetting
control
e For information about the reagents used on the analyzer, see:

Reagent concept on page B-129
Photometric unit
Light source Tungsten halogen lamp, 12 V / 50 W

Photometer Multiple wavelength spectrophotometer
Wavelengths 12 wavelengths available: 340, 376, 415, 450, 480, 505, 546,
570, 600, 660, 700, 800  2 nm
Optical path length 5.6 mm
Optical range 0.0000-3.0000 absorbance
Linearity Up to 2.5 absorbance
Optical mode Monochromatic and bichromatic
Roche Diagnostics
Analytical unit
ISE unit
Applications Na+, K+, Cl- in serum and urine

Detection system Ion-selective electrode system
Throughput 150 samples/h (corresponding to 450 tests/h)
Sample pipetting volume 9.7 L (6.5 L for urine manual rerun only)
Reagent consumption ISE Dil. 355 L/sample (dilution to 1/31)
ISE IS 710 L/sample (measurements in succession)
1420 L/sample (single measurement)
ISE Ref. 130 L/sample (measurements in succession)
(KCl) 195 L/sample (single measurement)
Measuring range (serum) Na+ 80-180 mmol/L
K+ 1.5-10.0 mmol/L
-
Cl 60-140 mmol/L
Measuring range (urine) Na+ 10-250 mmol/L
+
K 1-100 mmol/L
Cl- 10-250 mmol/L
Measuring range (urine rerun Na+ 250-375 mmol/L
with reduced sample volume) K +
100-150 mmol/L
-
Cl 250-375 mmol/L
Measuring temperature 37  2C (during operation  0.5C)
Cycle time 24 s
Liquid level sensor Capacitance sensing technology
Mixing method Non-contact ultrasonic mixing
Bottle volume ISE IS 600 mL
ISE Dil. 300 mL
ISE Ref. 300 mL
Reagent pipetting volumes Volume ISE IS ISE Dil. ISE Ref.

during analysis Aspirated from reagent bottle 710 L 355 L –
Discharged to reaction cell (a) 450 L 291 L –
Aspirated by the ISE sipper 400 L 250 L(b) 65 L
Table A-8 Reagent pipetting volumes during analysis
(a) The discharged volumes are lower because of the required dummy volume of the reagent pipetter.
(b) Diluted sample. Dilution ratio 1:31
e For a description of an ISE analysis flow, see:

Flow of ISE analysis on page A-63.
Roche Diagnostics
Other specifications
In addition to specifications of the control unit and the analytical unit themselves,
this section provides an overview of specifications of the system interface, barcodes,
and sample containers.
System interface
The instrument can be bidirectionally interfaced with a Host.
System interface RS-232C serial interface
e For information about the serial interface, refer to the Host Interface Manual.
All data processing equipment connected to the system must comply with the relevant
standards (IEC 950, UL 1950, CSA 22.2 No. 950).
Sample cups and tubes
Sample cups (both standard and micro cups) can be inserted into sample tubes with
16 mm diameter (cup on tube) or they can be used without tubes.
Container Diameter  length Minimum sample

volume (dead volume)
Primary sample tube 16 mm  100 mm 1000 L
13 mm  75 mm 500 L
Hitachi standard cup 17 mm  38 mm, 2.5 mL 100 L
Hitachi micro cup (a) 8 mm  37 mm, 1.5 mL 100 L(b)
Roche false bottom tube(c) 13 mm  75 mm 70 L
Freely definable type of 12-16 mm  73-102 mm
false bottom tube /
non-standard tube(c)
Table A-9 Sample containers
(a) Not applicable to calibrators and QCs
(b) A dead volume of 50 L is available if the Hitachi micro cup is directly loaded on the sample disk (not
as a cup on tube) and the sample cup size is set to Micro on the Workplace > Test Selection screen.
(c) Only one type of false bottom / non-standard tube can be used on the analyzer at the same time.
Avoid overfilling sample tubes and cups

Leave approx. 10 mm clearance between the liquid and the top of the tube or cup.
e For a figure of sample cups and tubes, see

Sample containers on page A-42.
Roche Diagnostics
Barcode specifications
Barcodes used with the cobas c 311 analyzer must be in compliance with one of the
following standards:
o NW7 (Codabar)
o Code 39
o ITF
o Code 128
Incorrect results due to undetected scanning errors

Barcode scanning errors could potentially go undetected when a check digit is not used.
CAUTION o Use only barcodes with check digits.
o Use only barcode labels of a good printout quality.
Sample barcodes The following specifications apply to the various barcode types:
Reading method Scanning with CCD sensor

Used barcode symbol NW7 (Codabar), Code 39, ITF, Code 128
Check digit Must be used to prevent scanning errors.
Number of ID digits NW7 2-22 digits + 1 digit (with check digit)
Code 39 2-22 digits + 1 digit (with check digit)
ITF 3-21 digits + 1 digit (with check digit)
Code 128 3-22 digits + 2 digits (with check digit)
Characters usable for ID NW7 o 0 to 9 (without check digit)
o 0 to 9, -, /, ., , $, :, + (with check digit)
Code 39 0 to 9, A to Z, -, ., [ ], /, +, $, %
ITF 0 to 9
Code 128 Alphanumerics (excluding those assigned to
functions and communications)
Check digit NW7 Modulus 16, Modulus 11, Modulus 10/2 weight,
Modulus 10/3 weight, 7 check DR, weighted
Modulus 11
Code 39 Modulus 43
ITF Modulus 10/3 weight
Code 128 Modulus 103
Roche Diagnostics
Scan range for sample barcodes Stick the label in exact alignment with the centerline of the sample tube in order to
prevent scanning errors.
100 mm 75 mm
sample tube sample tube
Scan range
88 mm
Figure A-36 Scan range of sample barcode reader
Specifications of barcode labels Secure a margin of 5 mm or more on each edge of barcode label.
 66 mm for 100 mm sample tubes
 53 mm for 75 mm sample tubes
Figure A-37 Specifications of barcode labels
Bar and space Minimum bar (space) width 0.19 up to 0.20 mm

Ratio of narrow bar (space) to wide bar 1 : 2.5 to 3
(space)
Reflectance and Space reflectance  75%
PCS value PCS value  0.7
Colors Bar black
Space white
Other Bar print must not be blurred.
Label indications must not be contaminated.
This is the last page of Part A.
Roche Diagnostics
Roche Diagnostics
Operation B
4 Safety information for operation . . . . . . . . . . . . . . . . . . . . . . . B-3

5 Software basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-5
6 Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-35
7 Orders and results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-85
8 Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-127
9 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-149
10 QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-177
11 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-211
cobas c 311 analyzer 4 Safety information for operation
Safety information for operation

Make sure that you have read and understood the chapter General safety information. The
following safety messages in particular are relevant:
Warning messages:
o Electrical shock by electronic equipment on page A-8
o Infection by samples and associated materials on page A-8
o Infection and injury due to sharp objects on page A-9
o Skin inflammation or injury caused by reagents and other working solutions on
page A-9
o Infection by waste solution on page A-9
o Contamination of the environment due to inappropriate treatment of waste on
page A-10
Caution messages:
o Personal injury due to contact with moving parts on page A-10
o Incorrect results due to incorrect reagent volume on page A-10
o Incorrect results and interruption of analysis due to contaminated samples on
page A-11
o Incorrect results due to evaporation of samples or reagents on page A-11
o Incorrect results due to carryover on page A-11
o Fatigue due to long hours of operation on page A-11
o Spillage on page A-11
Observe the system safety labels illustrated and described starting on page A-14.
Before starting to work with the analyzer, read the following safety messages
carefully. If you ignore these safety messages, you may suffer serious or fatal injury.
Infection and injury due to contact with instrument mechanism

Contact with the sampling mechanism or other mechanisms may result in personal injury
WARNING and infection.
o Whenever possible, keep the top cover and the front cover of the analytical unit closed.
replacement of ISE reagents), always put the analyzer in Maintenance mode or in
o Do not open the top cover while the analyzer is operating.
o Do not touch any parts of the instrument other than those specified.
o Observe all instructions given in this manual very carefully.
Infection due to contact with splashes of reaction solution or by inhaling reaction

solution aerosol from the ultrasonic mixer
Keep the top cover closed and in place while the instrument is operating.
Roche Diagnostics
Operator’s Manual · Version 2.0 B-3
4 Safety information for operation cobas c 311 analyzer
Incorrect results due to position mismatch

o Be sure to load samples and reagents only into the specified positions on the
CAUTION instrument.
o When operating in non-barcode mode, make sure to load the samples according to the
Requisition list provided by the analyzer.
Incorrect results due to expired reagents or mixing reagents

Data obtained using expired reagents are not reliable. Mixing together new reagent and
residues of old reagent may also lead to incorrect results.
o Do not use reagents that have exceeded their expiration dates.
o Do not top off old reagent with new reagent. When a bottle is empty, replace it with a
new one.
Incorrect results due to missing covers of the ISE unit

If the cover of the ISE measuring compartment or the cover of the sipper nozzle are not
reinstalled after maintenance, the temperature level or the noise level may be affected,
leading to incorrect results. Touching any ISE component or opening the front doors may
also affect the noise level and lower measurement precision.
o Only perform measurement, if the covers of the ISE unit are installed.
o Do not open the front doors during measurement.
o Do not touch the ISE Ref. tube, the ISE unit, or the sipper nozzle cover during
measurement.
Incorrect results due to aspiration of air

Incorrect pipetting of the probes as well as incorrect adjustment of the probe position may
result in aspiration of air, leading to incorrect results.
o Check the instrument performance by performing control measurements.
o Perform maintenance procedures regularly.
Incorrect results due to incorrect mixing volume

The permissible volume of reaction solution to be mixed by the ultrasonic mixer is 100 to
250 L. If the volume is outside this range, the reaction solution may not be mixed
correctly, leading to incorrect results.
o Make sure that the volume of reaction solution stays in the range of 100 to 250 L,
especially when loading a new application onto the analyzer.
o For information on analytical parameters of each reagent, contact its manufacturer.
Roche Diagnostics
B-4 Operator’s Manual · Version 2.0
cobas c 311 analyzer 5 Software basics
Table of contents
Software basics
This chapter is an introduction to the basic operational procedures for the


General description of the user interface ...................................................................... B-7
Fixed areas ......................................................................................................................... B-8
Status line .................................................................................................................... B-8
Help button and guidance prompt .......................................................................... B-9
Global buttons .......................................................................................................... B-10
Main menus .................................................................................................................... B-11
System Overview ...................................................................................................... B-11
Workplace ................................................................................................................. B-12
Reagent ...................................................................................................................... B-13
Calibration ................................................................................................................ B-14
QC .............................................................................................................................. B-15
Utility ......................................................................................................................... B-16
Software elements .......................................................................................................... B-17
Menus, screens and tabs .......................................................................................... B-17
Buttons ...................................................................................................................... B-19
Buttons with black triangles and gray buttons .............................................. B-19
Standard buttons ................................................................................................ B-20
List boxes ................................................................................................................... B-21
Text boxes ................................................................................................................. B-22
Check boxes .............................................................................................................. B-22
Options ...................................................................................................................... B-23
Windows ................................................................................................................... B-23
Roche Diagnostics
5 Software basics cobas c 311 analyzer
Table of contents
The help system of the instrument .............................................................................. B-24

About F1 Help .......................................................................................................... B-24
The F1 Help window ............................................................................................... B-25
Button bar ........................................................................................................... B-25
Navigation pane ................................................................................................. B-26
Topic area ........................................................................................................... B-26
Searching for information in the help system ...................................................... B-27
Search options and recommendations ........................................................... B-29
Using favorites .......................................................................................................... B-30
Printing F1 Help topics ........................................................................................... B-31
Shortcut keys ................................................................................................................... B-32
Roche Diagnostics
General description of the user interface
General description of the user interface
The screen representations shown in this chapter and throughout this manual are for
illustrative purposes only. The screens do not necessarily show valid results.
The screen of the analyzer software is divided into four different areas. Following is
an example of a screen showing the different areas.
A Status line C Global buttons

B Menu area D Help button and guidance prompt
Figure B-1 Screen configuration
Fixed areas The three outer areas are fixed and accessible from every screen:
o The status line provides information about the current status.
o The Help button and the guidance prompt provide support that is specific to the
current menu and the location of the cursor.
o The global buttons provide access to specific functions.
e See Fixed areas on page B-8
See The help system of the instrument on page B-24
Menu area The menu area in the center changes according to the currently active menu or
function. Standard software elements like buttons, menu tabs, windows, etc. are used
in the menus. If you are not familiar with these elements, we recommend that you
read the section Software elements first.
e See Main menus on page B-11
See Software elements on page B-17
The software can be operated by touchscreen, mouse or keyboard.

e For information about operation with the keyboard, see
Shortcut keys on page B-32.
Roche Diagnostics
Fixed areas
Fixed areas
This section discusses the three areas that appear at the top, the lower left and the
right side of each screen.
Status line
The status line appears across the top of each screen.
A BC D E F
A Status icon for the host D Operational mode of the analyzer

B Status icon for the core unit E Operator ID (logon name)
C Status icon for the analytical unit F Current date and time
Figure B-2 Status line
The status line displays the current status of the units, operational mode, operator ID,
date and time, and the time remaining when performing maintenance.
Status icons The three status icons on the left display the current statuses of the units:
o Host: external system. This icon is only visible if the host communication is
enabled in the Start Conditions window.
o Core unit
o Analytical unit (AU)
Call up the System Overview screen from any other screen

Touching one of the status icons on any screen will display the System Overview screen.
The System Overview screen provides information about the selected unit.
Roche Diagnostics
Fixed areas
Status colors The status colors represent the operational mode and additional information of each
unit or component. The following describes the status colors from the highest to the
lowest priority:
Color Meaning
Red Indicates an instrument alarm at the Stop, S.Stop or E.Stop level
or that a reagent is empty and there is no second cobas c pack
placed on this analyzer.
Yellow Indicates an instrument alarm at a caution level or that the
number of remaining tests is below the yellow alarm level
threshold.(a)
Purple Indicates that the number of tests remaining for a diluent, test
reagent or detergent volume is less than the daily requirement(a) -
only applicable if the Preventive Action check box has been
selected.
Light blue Indicates a status other than Standby (e.g., Operation or
Maintenance).
Light green Indicates Standby mode.
Table B-1 Color scheme of the status icons for each unit
(a) Specified on the Utility > System (Page 2/5) > Reagent Level Check window.
Screen accessibility
Some screens are not accessible with the operator level logon, or can be viewed with a
supervisor level logon but not edited. Some fields are viewed only at the administrator level
logon.
Help button and guidance prompt
The Help button and the guidance prompt are shown in the lower left of each screen.
A B
A Help button B Guidance prompt
Figure B-3 Help button and guidance prompt
Help button The Help button displays context-sensitive help.

e For information about using the Help button, see
The help system of the instrument on page B-24.
Guidance prompt In this area, the software prompts you as to what kind of information to type and
what format to use when typing that information. The guidance prompt may also tell
what action to take, such as touching a button or pressing a key. For example, “Touch
screen or press <Enter>”. Each prompt is specific to the location of the cursor.
Roche Diagnostics
Fixed areas
Global buttons
Use the global buttons to display screens that are used for specific functions. The
global buttons are accessible from every screen and appear on the right side of the
screen.
Figure B-4 Global buttons
The global buttons include the following functions:
Global button Function

Stop To stop operation, e.g. a running analysis or maintenance
procedure. All results currently being processed will be lost.
Shut down o To log-off the operator
o To put the analyzer in Sleep mode
o To shut down the analyzer
S. Stop To stop sampling.
Alarm To display the alarm list and the countermeasures. If an alarm
was issued, the Alarm global button flashes yellow or red.
Print To print information, e.g. the requisition list, calibration and QC
results, or patient reports.
Pause/Scan o To pause the sample disk, e.g. to add samples on the disk
o To scan sample cups before analysis. The sample disk rotates
and checks if a position on the sample disk is occupied.
Start To select start conditions and to start analysis.
Table B-2 Functions of the global buttons
The Stop, S. Stop and Start buttons are also the system control buttons. The global
buttons can be selected by touchscreen, mouse or keyboard.
e For information about operation with the keyboard, see
Roche Diagnostics
Main menus
Main menus
The graphical user interface used by the control unit consists of the System Overview
screen and 5 main menus, Workplace, Reagent, Calibration, QC and Utility. Each
menu consists of two or more screens. Through these screens all instrument
functions are controlled.
Access to some screens, especially those of the Utility menu, is restricted by the
access level of the user. For this reason, the screen may not appear exactly as shown
here.
Standard software elements like buttons, menu tabs, windows, etc. are used in the
menus. If you are not familiar with these elements, we recommend that you read the
section Software elements first.
e See Software elements on page B-17
System Overview
The System Overview screen has a central role within the cobas c 311 analyzer
software. This screen provides an overview of the whole system at any given time. It
can be used to prepare the analyzer for daily routine operation.
A Work Flow Guide, guides you through the preroutine operation

B Overview area, provides information about the selected unit
C Print View button, displays a preview of current data
D Buttons to open the main menus
Figure B-5 System Overview screen

System Overview screen on page B-44
Roche Diagnostics
Main menus
Workplace
The Workplace menu consists of 2 screens: Test Selection and Data Review.
The Test Selection screen is used to perform the following:
o To make test selections
o To specify patient demographics
o To assign patient ID numbers and disk positions to samples
The Data Review screen is used to perform the following:
o To review data
o To backup data
o To edit data
o To delete data
o To send data to the Host
Figure B-6 Workplace menu

Test Selection screen on page B-88
Data Review screen on page B-105
Roche Diagnostics
Main menus
Reagent
The Reagent menu consists of 2 screens: Setting and Status. These screens are used
to view detailed reagent information and to load and unload reagents.
Figure B-7 Reagent menu

Reagent Setting screen on page B-139
Reagent Status screen on page B-140
Roche Diagnostics
Main menus
Calibration
The Calibration menu consists of 3 screens: Status, Calibrator and Install. These
screens are used to request calibrations, define calibrators and view the reaction
curves for calibrators installed on the system. The calibration mode for the next start
up calibration or for an intermediate calibration can be determined from here. If an
intermediate calibration is necessary, it can be requested by test and calibration type.
Figure B-8 Calibration menu

Calibration Status screen on page B-156
Calibration Install screen on page B-166
Calibration Calibrator screen on page B-174
Roche Diagnostics
Main menus
QC
The QC menu consists of 6 screens: Status, Run Status, Individual, Cumulative,

Control, and Install. Use these screens to install, view and edit controls, and to
evaluate, accumulate and print quality control results.
Figure B-9 QC menu

QC Status screen on page B-184
QC Run Status screen on page B-188
QC Individual screen on page B-190
QC Cumulative screen on page B-199
QC Control screen on page B-200
QC Install screen on page B-202
Roche Diagnostics
Main menus
Utility
The Utility menu consists of 7 screens: System, Maintenance, Application,

Calculated Test, Special Wash, Report Format, and Module Set. These screens are
used to enter system parameters, application parameters, maintenance settings and
system settings.
A Page button
Figure B-10 Utility menu
Page buttons The Utility > System screen displays page buttons that can be used to display
additional buttons to display new screens. These page buttons are numbered (X/5), to
indicate which page you are on.
The page buttons only change the displayed buttons and not the entire appearance of the
screen.

System configuration on page B-235
Performing maintenance items on page C-9
Application on page B-213
Calculated Tests on page B-249
Special Wash on page B-255
Report Format on page B-261
Module Set on page B-247
Roche Diagnostics
Software elements
Software elements
These elements are used to navigate through the software, to select a choice or
function, and to type in information.
Menus, screens and tabs
The menu tabs are displayed below the status line.
A
B
C
A A tab
B Menu tabs
C Screen tabs (for submenus)
D A screen (the Utility > System screen)
Figure B-11 Menus, screens and tabs
Menus The menu tabs are used to select screens and windows that are grouped together and
perform related tasks. The menu tabs are accessible from every screen, except the
global screens. This makes the software navigation within the menus and between
menus very easy.
The menu tabs are only for the 5 menus: Workplace, Reagent, Calibration, QC and
Utility. The menu tabs can be selected by touchscreen, mouse or keyboard. The
selected menu is colored blue.
Screens Each menu contains of two or more screens. Screens are frequently also called
submenus. The example asks you to select the Utility menu and therein the System
screen.
Example: Choose the Utility > System screen.
Roche Diagnostics
Software elements
Tabs Tab is the common name for a special kind of button, with which you can switch
between menus.
Menus
Screens
A Tabs(a)
A The Calib. tab in the Utility > Application screen (cutout)
Figure B-12 Example of a tab and the hierarchical structure of menus, screens and tabs
(a) Tabs appear only in the Utility > Application screen, in the Workplace > Test selection screen, in a few
windows and a few global menus.
In this document, the term tab is mostly used as a generic term for subscreens or
subwindows. Subscreens appear in two screens (see Figure B-12) and a few windows
and global menus use subwindows (see Figure B-13, C).
Example: Choose the Calib. tab on the Utility > Application screen.
This is equal to: Choose the Utility > Application > Calib. screen.
Roche Diagnostics
Software elements
Buttons
Buttons are used for execution of functions, confirmation of entries and selections,
and displaying pop-up windows. The available buttons depend on the menu or
screen that is active.
B D
A Normal button C Utility tab of the Print menu

B Button that displays another window (black D Button that performs the function and closes
triangle in the upper right corner) the window (black triangle in the lower left
corner)
Figure B-13 Examples of buttons
There are several ways to choose a button:

1. Touchscreen: Choose a button by touching it on the screen.
2. Keyboard: Press the <Arrow> keys or the <Tab> key to highlight a button. Press
the <Enter> key to initiate the action.
Buttons with black triangles and gray buttons
Black triangle The black triangle in the upper right corner of a button indicates that touching this
button displays another window (see Figure B-13, B).
The black triangle in the lower left corner of a button indicates that touching this
button performs the specified function and closes the window (see Figure B-13, D).
Text color on buttons If the text on the button is black, the button is available in the current mode. If the
text on the button is gray, the button is not available in the current mode.
Roche Diagnostics
Software elements
Standard buttons
The following buttons are used throughout the software. These buttons are explained
below and will not be explained again with each individual screen.
OK Touch this button to accept the changes and entries made on a window and to close
the window.
Cancel Touch this button to close the window without saving the changes and entries made
on a window.
Yes Touch this button to accept the changes made on a window, execute the action of the
window (e.g., Delete) and close the window.
No Touch this button to close the window without saving the changes made on a window
or without executing the function of the window (e.g., Delete).
Close Touch this button to close the window.
Save Touch this button to save any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.
Update Touch this button to update any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.
Execute Touch this button to accept the changes made on a window, to execute the action of
the window and to close the window.
Roche Diagnostics
Software elements
List boxes
List boxes display a list of choices. If there are more choices than can fit in the box, a
scroll bar is displayed. List box is a generic term for any type of dialog box option
containing a list of items the user can select.
A Open list box B Drop-down list box

C Drop-down list box currently not available
Figure B-14 Examples of list boxes
To select an item in a list box:

1. Touchscreen: Touch the desired area within the list box on the screen. If a scroll
bar is displayed next to the list box, touch the scroll bar above or below the
current display position, or touch the arrows on the scroll bar to move up or
down the list.
2. Keyboard: The <Arrow> keys can be used to move quickly through the list. Press
the <Arrow> key that points in the direction you want to move. The currently
selected choice is indicated by the selection cursor, which appears as a highlight.
The <Home>, <End>, <Page Up>, and <Page Down> keys can also be used to
move through the list. When the desired item is highlighted, press <Enter>.
Roche Diagnostics
Software elements
Text boxes
Text boxes are used to type information. When you move to an empty text box, the
box is highlighted.
Figure B-15 Example of a text box
To type in information in a text box:

1. Touchscreen: Move to a text box by touching it on the screen. The text box
highlights when you touch it.
2. Keyboard: Move to a text box by pressing the <Tab> key. The text box highlights
when you move to it.
Press the <Enter> key to accept information typed. The cursor then moves to the next
field.
Check boxes
Check boxes are used to select a particular function. Sometimes when an option is
selected, additional fields become available. Multiple check boxes can be selected in
the same area of the screen.
es
Figure B-16 Example of a check box
To select a check box:

1. Touchscreen: Move to the check box by touching it on the screen. A check mark
appears in the check box when it is selected. When the check box is blank, it is not
selected.
2. Keyboard: Move to the check box by pressing the <Tab> key. If multiple check
boxes are available, the <Up Arrow> and <Down Arrow> keys move to the
different check boxes.
Roche Diagnostics
Software elements
Options
Options are used to select a particular function. Sometimes when an option is

selected, other fields become available.
Figure B-17 Example of options
An option is selected when a black circle is displayed within the white circle for the
option. Only one option can be selected at a time.
1. Touchscreen: Move to the option by touching it on the screen. The option
displays a black circle within the white circle when you touch the option.
2. Keyboard: Move to the option by pressing the <Tab> key. If multiple options are
available, the <Up Arrow> and <Down Arrow> keys move to the different
options.
Windows
Windows contain additional information that pops up over existing screens.
Figure B-18 Example of a window
Windows function similar to screens. Information on a window can be entered or

edited through list boxes, text boxes, options, check boxes and action buttons.
Confirmation Window Many functions require confirmation prior to their execution (e.g., Delete).
Confirmation windows are used to confirm these functions. Touch Yes to confirm
the function and to close the confirmation window, or touch No to close the
confirmation window without carrying out the function.
Roche Diagnostics
The help system of the instrument
The software of the cobas c 311 instrument has a context-sensitive online help system
to support you in operating the instrument.
Context-sensitive means that the help system always displays information related to
the current window or software element. Therefore, the help system offers a quick
and convenient way to find information.
A
A F1 Help button
Figure B-19 Online Help button
e For more information on F1 Help, see:

About F1 Help on page B-24
Searching for information in the help system on page B-27
Printing F1 Help topics on page B-31.
About F1 Help
This help feature displays information related to the current window.
a To display the F1 Help feature for the current window

1 Open the menu or window for which you want detailed information.
2 Choose the Help icon in the bottom left corner of the screen or press <F1> on the
keyboard.
The help window opens displaying the desired help information. Hypertext links
guide you to additional information and procedures related to this window.
Operator’s Manual included in the F1 Help system

The Operator’s Manual is included in the F1 Help system. This allows you to search for
information throughout the software reference and the manual. All cross-references are
implemented as hyperlinks.
Roche Diagnostics
The F1 Help window
The F1 Help window comprises three main areas:

o Button bar
o Navigation pane
o Topic area
A Button bar C Topic area

B Navigation pane
Figure B-20 Area of the F1 Help window (example screenshot from the English version)
Button bar
The buttons at the top of the help window provide the following functions:
Hide / Show Allows you to show or hide the navigation pane. This feature
provides more space in the topic area, which may be desired for
displaying large figures.
Previous / Next Use these buttons to open the topic above or below the current
topic. If there is no topic to view above, the Previous button is
unavailable.
Back / Forward Use these buttons to backtrack through the topics you have
previously reviewed in the order in which you viewed them. The
record of topics viewed is deleted each time you exit the
F1 Help.
Refresh This is a standard function of Internet browsers for refreshing
the screen. You do not need this button to display the F1 Help.
Print Prints the topic currently displayed in the topic area.
Help Directs you to information about the help system (help on help).
Roche Diagnostics
Navigation pane
The navigation pane appears to the left of the help window. There are four tabs
available at the top of the pane: Contents, Index, Search, and Favorites.
o The Contents tab uses book and page symbols to display the contents of the
F1 Help and remains synchronized with the topic displayed in the topic area.
o The Index tab provides access to the help index.
o The Search tab provides access to a full-text search feature.
o The Favorites tab allows organizing important topics with your personal
bookmarks.
A Button bar C Topic area

B Navigation pane
Figure B-21 Areas of the F1 Help window (example screenshot from the English version)
e For information on the Contents, Index, Search, and Favorites tabs, see:
Searching for information in the help system on page B-27
Using favorites on page B-30.
Topic area
Help topics appear in the area to the right of the navigation pane. The topic area
comprises the description related to the topic selected in the navigation pane.
If the topic extends beyond the window, scrollbars allow you to view the rest of the
topic.
Related topics All subtopics to the current topic are listed at the end of each topic.
Alternatively, you can navigate to subtopics using the Next button or using the
Contents tab.
Links Cross-references to associated topics are indicated by blue text. When you hover over
a link, the mouse pointer changes to a hand icon.
Roche Diagnostics
Searching for information in the help system
There are various methods of finding the desired information in the F1 Help. Select
your preferred method.
o The Contents tab displays the structure and contents of the cobas c 311 help
system allowing you to navigate to the desired location.
o The Index tab displays a list of predefined keywords based on the topic titles and
words or phrases in the help system.
o The Search tab allows you to perform a full-text search in the help system.
a To use the Contents tab

1 Choose the Help icon in the bottom left corner of the screen or press <F1>.
The F1 Help window appears displaying information related to the current
window of the user interface.
2 If you require information about another topic, use the navigation pane on the
left:
o Double-click on a book symbol to further expand the contents structure (or

click on the plus symbol). The structure in the navigation pane expands
showing the available topics.
o Click on a book symbol or a page symbol to display the corresponding topic.

o Use the scroll bar of the navigation pane to scroll up and down within the
topics of the help system.
a To use the Index tab

1 In the F1 Help window, choose the Index tab to display the list of index entries.
2 Type the desired index entry or scroll through the index list. As soon as you start
typing the index entry, the entries that most closely match the text that you type
are displayed in the index list.
3 When you have found the desired index entry, double-click the entry or select the
entry followed by Display to display the topic in the topic area.
Roche Diagnostics
a To use the Search tab

1 In the F1 Help window, choose the Search tab.
Figure B-22 Search tab (example screenshot from the English version)
2 In the text box, type search term(s) you want to find.

3 Choose the List Topics button to show the search results.
4 The bottom list displays the titles of topics that match the search term(s).
5 Double-click a topic title to display this topic in the topic area.
Or: Select the topic title and choose the Display button.
Roche Diagnostics
Search options and recommendations
Recommendations for better The number of search results is displayed above the result list (Found: xx).
search results
Problem Recommendation
Too many search results 1. Select the Search titles only check box.
2. Deselect the Match similar words check box.
3. Select the Search previous results check box and enter a
new search term(s) that is associated with your desired
information.
4. Connect two or more search terms with AND, OR,
NEAR, or NOT (see arrow button on the right of the text
box).
The desired information is 1. Select the Match similar words check box.
not contained in the search 2. Deselect the Search previous results and the Search
results titles only check boxes.
3. Maybe you are using terms that are different from the
terms used in the help system. Use the Index tab for your
search.
Table B-3 Recommendations
Search options The following describes the search options for the F1 Help:
AND Use this option to join words or phrases when both (or all) terms
must appear in the search results.
OR Use this option to join synonymous or related terms when either
(or both) of the terms must appear in the search results.
NEAR Use this option to find words within 10 words of each other.
NOT Use this option to exclude a particular word or combination of
words from your search results.
Search previous results Select this check box to limit the search results and search
through your results list from previous search.
Deselect this check box if you want to search through all of the
files in the online help.
Match similar words Select this check box to find similar words and minor
grammatical variations for the phrase you search.
Search titles only Select this check box to search titles only.
Deselect this check box for a full text search.
Table B-4 Search options
Roche Diagnostics
Using favorites
You can add a favorite, also called bookmark, to online help topics that you want to
visit again. The favorites work similar to the favorites in your web browser.
a To add a favorite
1 In the F1 Help, search for or navigate to the desired topic.
Figure B-23 Favorites tab (example screenshot from the English version)
2 Choose the Favorites tab to display the list of favorites.

The topic title is displayed in the Current Topic text box.
3 To rename the topic, enter another name.
4 Choose the Add button. The new favorite is inserted in alphanumeric order.
Any time you want to open that topic again, choose the Favorites tab and then
select it from the Topics list.
Organizing favorites by prefixes

To organize a number of favorites, we recommend using a numeric prefix at least for each
main menu (e.g., 1 = Workplace, 2 = Reagents, ). All topics from the Workplace
menu will be appear together under the prefix 1.
a To rename a favorite
1 In the Favorites tab, select the desired favorite.
2 Right-click the favorite name and select Rename.
3 Type the new name and press <Enter>.
Roche Diagnostics
Printing F1 Help topics
You may find it useful to print a topic from the cobas c 311 online help.
a To print a help topic

1 In the F1 Help, search for or navigate to the desired topic.
2 To print the current topic, choose the Print button.
3 Check the printer settings and choose Print to print the selected topic.
Roche Diagnostics
Shortcut keys
Shortcut keys
All functions can be initiated via the keyboard or the touchscreen for selection of
screen items.
All special keys and their functions are described below.
Shortcut Description
<F1> Use this key to display the online help.
<F2> Use this key to display the Start Conditions screen.
<F3> Use this key to display the Sample Stop screen.
<F4> Use this key to display the Stop screen.
<F5> Use this key to display the Workplace menu. This key does not
work if you are in a global screen.
<F6> Use this key to display the Reagent menu. This key does not
<F7> Use this key to display the Calibration menu. This key does
not work if you are in a global screen.
<F8> Use this key to display the QC menu. This key does not work if
you are in a global screen.
<F9> Use this key to display the Utility menu. This key does not
<F10> Use this key to display the Sample Pause/Scan screen.
<F11> Use this key to display the Alarm screen.
<F12> Use this key to display the System Overview screen.
<Print/Print Screen> Use this key to display the Print screen.
Press <Shift>+<Print Screen> simultaneously to print the
current screen.
<Scroll Lock> Use this key to display the Cancel Print window.
<Pause/Break> Use this key to display the Shutdown screen with the options
Logoff, Sleep and Shutdown.
<Esc> Use this key to exit a window or global screen.
<Tab> Use this key to move to the next field in a window or screen. To
go from a field to the previous one, press <Shift>+<Tab>
simultaneously.
<Enter> Use this key to confirm an entry.
<Shift> Simultaneously pressing <Shift> and a character key generates
a capital letter or a special character, for example on an English
keyboard <Shift>+<,> generates the character “<”.
<Backspace> Use this key to delete a character to the left of the cursor.
<Space> Use this key to generate a space.
<Delete> Use this key to delete a character to the right of the cursor.
<Home> Use this key to place the cursor at the beginning of a list or text
box.
<End> Use this key to place the cursor at the end of a list.
<Page Up> Use this key to scroll upward in a list, one page at a time.
<Page Down> Use this key to scroll downward in a list, one page at a time.
Table B-5 Shortcut keys (Sheet 1 of 2)
Roche Diagnostics
Shortcut keys
Shortcut Description
<Arrow> Use these keys to move the cursor to the right, left, upwards or
downwards within a text box.
<Caps Lock> Use this key to lock the letter keys into the upper case mode.
<Num Lock> Use this key to activate the numerical keypad for entering
numbers and mathematical operators such as +, -, /, *.
Table B-5 Shortcut keys (Sheet 2 of 2)
Roche Diagnostics
Shortcut keys
Roche Diagnostics
cobas c 311 analyzer 6 Daily operation
Table of contents
Daily operation
This chapter provides a description of the everyday tasks which are required for
running the cobas c 311 analyzer. Common procedures that are performed as part of
the daily workflow are also described here.

Overview .......................................................................................................................... B-37
Starting the analyzer ...................................................................................................... B-38
Start-up inspection .................................................................................................. B-38
Instrument statuses .................................................................................................. B-40
Overview of instrument statuses ..................................................................... B-40
Maintenance mode ............................................................................................ B-42
Check system alarms ............................................................................................... B-43
System Overview screen .......................................................................................... B-44
Color scheme of the System Overview screen ............................................... B-45
Work Flow Guide .............................................................................................. B-47
Preventive action ............................................................................................... B-47
Preroutine operation ..................................................................................................... B-48
Daily Maintenance button ...................................................................................... B-48
Sample Data Clear button ....................................................................................... B-50
Reagent Preparing button ....................................................................................... B-51
ISE reagents ........................................................................................................ B-52
Loading cobas c packs ....................................................................................... B-55
Unloading cobas c packs ................................................................................... B-57
Calibration And QC Select button ........................................................................ B-58
Requesting calibration and QC and printing load lists ................................ B-59
Measuring calibrators and controls ................................................................ B-62
Validating calibration and QC results ............................................................ B-63
Parameter Download button .................................................................................. B-64
Sample Tracking button .......................................................................................... B-64
Roche Diagnostics
6 Daily operation cobas c 311 analyzer
Table of contents
Routine Operation ......................................................................................................... B-65

Processing routine samples .................................................................................... B-66
Test selection ...................................................................................................... B-66
Loading routine samples ................................................................................... B-67
Starting the measurement ................................................................................. B-68
Interruption of measurements ......................................................................... B-69
Processing STAT samples ....................................................................................... B-70
Test selection ...................................................................................................... B-70
Loading STAT samples ..................................................................................... B-70
Checking results and handling of data .................................................................. B-71
Sample tracking .................................................................................................. B-72
Checking for open test requests ....................................................................... B-73
Processing open test requests (with SBS mode) ............................................ B-75
Processing open test requests (without SBS mode) ...................................... B-76
Sending data to the Host ................................................................................... B-77
Archiving data and performing data backups ............................................... B-77
Printing sample information ............................................................................ B-79
Sampling Stop ........................................................................................................... B-80
Shutting down the analyzer .......................................................................................... B-81
Maintenance before shutdown .............................................................................. B-81
Analyzer shutdown and sleep mode ..................................................................... B-81
Checks after shutdown ............................................................................................ B-84
Roche Diagnostics
Overview
Overview
Daily operation Daily operation encompasses the routine tasks that are required to prepare and
maintain the analyzer, and to analyze samples. The layout of the System Overview
screen provides the operator with an intuitive guide to the tasks required for routine
operation.
The following diagram gives an overview of daily operation.
Starting inspection
Analyzer start-up
(Initialization and standby)
• Check Alarm button
Preroutine operation
• Preventive action
• Calibration and QC
Routine operation
• Routine or STAT sampling Rerun assigned
------------------------------------------------------
Results
Stop and standby
Maintenance
Shutdown
Figure B-24 Workflow diagram
Certain maintenance items must be performed every day before the start of analysis.
We recommend performing the Power ON pipe every day during the Power ON procedure.
e For detailed information see:
Power ON pipe on page C-17
Roche Diagnostics
Starting the analyzer
Before you can start routine operation, you must first prepare the analyzer for
operation.
Start-up inspection
Before start-up, it is important to check that all of the following conditions are met. If
a condition is not met, take the necessary remedial action.
Before performing the following actions, observe the following safety precautions:
page A-9
o Before starting the instrument, always check that:
Check that: Page

Control unit There is no floppy disk in drive A.
There is sufficient paper in the printer.
Analyzer The water supply is switched on. A-66
The container for highly concentrated waste is clean and A-66
empty, and placed in the correct position.
All connections and fittings of tubes and containers are
connected properly and are not leaking.
The cell covers are free of contamination. If necessary, clean C-62
the cell covers using a gauze pad moistened with alcohol.
There is enough volume in the auxiliary reagent bottles and B-52
ISE reagents.
e See also: ISE area components on page A-59
Auxiliary reagents and detergents on page B-132
The sample probe, reagent probe, sipper nozzle and rinse C-51
nozzles are clean. In case cleaning is necessary, take the C-55
appropriate maintenance actions described.
No liquid is leaking inside the ISE compartment and the C-96
electrode wires are connected properly.
Table B-6 Checks before starting the instrument
During operation, always check for any abnormal sound, water leakages or other abnormal
condition. If a trouble occurs, take suitable safety measures according to the condition and
contact your Roche service representative.
Roche Diagnostics
a To switch on the analyzer

System time: approximately 6 minutes (unless a Power Up Pipe function has been
programmed)
Please note that there is a prescribed order for switching on and off. The following
order has to be observed:
1 Switch on the power switch located on the right of the analytical unit.
The analyzer starts the initialization routine.
A B
A Power switch of analytical unit B Power switch of control unit
Figure B-25 Power switches
2 Switch on the computer of the control unit, the monitor, and the printer.
After initialization, the Logon screen is displayed.
3 Enter your operator ID and password to log on.
4 Choose OK to gain access to the software and begin operation.
When initialization has been completed, the system goes into Standby.
Some maintenance items must be performed daily at start-up of the analyzer. We

recommend performing them automatically by a maintenance pipe function.
e For information about maintenance pipes and about daily maintenance, see:
Maintenance pipes on page C-10
Daily maintenance—at power on or start up on page C-37
Sleep mode
Instead of switching off power after the working day, the analyzer can also be put into
sleep mode. Sleep mode provides the possibility of an automatic start-up on the next day.
Note that when the analyzer wakes up from sleep mode, the control unit performs a
shutdown to reset the PC operation software (Windows XP).
e For information about sleep mode and shutting down the analyzer, see:
Analyzer shutdown and sleep mode on page B-81.
Roche Diagnostics
Instrument statuses
This section explains the most important operational statuses (modes). The status is
displayed in the upper left of the monitor.
Figure B-26 Instrument status, e.g. Standby mode
Check the upper left of the monitor before starting a new analysis or a maintenance
item:
o Stand By: If Stand By is displayed with a white background, the analyzer is ready
to start a new analysis or a system-controlled maintenance item. The top cover
must be closed.
o Maintenance mode: If the status line is displayed with a yellow background, the
analyzer is ready for maintenance actions that are performed with the top cover
open.
e For information about the required status for each maintenance item, see:
Overview of maintenance schedules on page C-34
Overview of instrument statuses

The following table shows the most important statuses:
Status Explanation
Power Up Status while the instrument is loading programs, performing
self-checks etc.
Initialize Status while the instruments performs any kind of initialization
– after power up or before being operative.
Standby Status when the instrument does not perform any measurement
activities or automatic maintenance procedures – but only a
limited initialization or preparation is required.
Preparation Status while the instrument prepares any kind of reagent or
other liquid.
Operation Status while the instrument is pipetting, measuring or
calculating.
Sample Reception Mode After all test requests are completed, the instrument waits for
additional samples. New samples will be processed immediately
after pressing the Start button.
Table B-7 Instrument statuses (modes) (Sheet 1 of 2)
Roche Diagnostics
Status Explanation
Sampling Pause After pressing Pause on the Sample Pause / Scan window
during operation, the status changes to Sampling Pause.
Additional samples can be loaded onto the sample disk. The
analyzer continues operation after pressing the Start button.
S.Stop After pressing the S.Stop button, the status changes to Sampling
Stop and then to Standby. Already pipetted samples will be
completed before sample processing is stopped.
E.Stop Status indicating that the system has performed an emergency
stop due to hardware failure or because any of the safety devices
requested an emergency stop. The system requires either a
complete power off or at least a reset (Utility > Maintenance) to
resume normal operation.
Standby with yellow Maintenance mode: Status for all actions that are performed
background with the top cover open. The low voltage power to the pipetters
and the reaction disk is switched off by means of the
maintenance switch without having to go into complete
shutdown.
e See: Maintenance mode on page B-42
Shutdown status The analyzer and control unit are disconnected and the
operation power switch is switched off. However, power for
keeping the reagents cool is still supplied.
Table B-7 Instrument statuses (modes) (Sheet 2 of 2)
Procedure for shutdown

If power to the analyzer is switched off prior to the complete shutdown of the computer,
the instrument may not start up properly when power is supplied again.
o Make sure the monitor indication has changed from shutdown to a state where
nothing is displayed.
o Then, switch off the analyzer power switch.
e See: To shut down the analyzer on page B-83
Roche Diagnostics
Maintenance mode
In Maintenance mode, the motors driving the pipetter probes, the sample disk and
the reaction disk are turned off, while the analyzer remains powered on.
Any actions which require the top cover to be open (such as replacing ISE reagents or
maintenance actions, or checks) may only be performed in Maintenance mode (or
shutdown).
A Maintenance switch
Figure B-27 Maintenance switch
a To put the analyzer in Maintenance mode (yellow bar in status line)
NOTICE Damage to the analyzer due to improper use

Always confirm that the analyzer is in Standby status before you activate the
maintenance switch. If you use the maintenance switch to change to Maintenance
mode while the analyzer is in Operation status or Sampling Stop status, the analyzer
stops operation and may be damaged.
o Make sure that the analyzer is in Standby before you put it into Maintenance mode.
1 Turn the maintenance switch (located on the right side of the analytical unit) to
Maintenance Mode.
The status line turns bright yellow. The yellow color indicates that the analyzer is
in Maintenance mode, even if Stand By is still displayed.
Figure B-28 Maintenance mode indicated by the yellow status line
2 Unlock and open the top cover of the analyzer.
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a To terminate Maintenance mode

1 Close and lock the top cover of the analyzer.
2 Turn the maintenance switch to Operation mode.
The status line turns back to white. Stand By is displayed.
3 Perform a reset in Utility > Maintenance to return all mechanical parts to their
home positions.
Check system alarms
If an alarm was issued, the Alarm global button flashes. The color of this button
stands for the alarm level. Yellow indicates the caution level and red the stop level.
When the global button Alarm flashes, it is necessary to open the Alarm screen to
view the alarm. The Alarm screen identifies all system alarm conditions.
Figure B-29 Alarm screen
a To review the Alarm screen

1 Choose Alarm (global button) to display the Alarm screen.
2 Select an alarm to view the description and remedies (displayed in the lower half
of the screen).
3 Correct any alarm conditions by following the remedies.
e If any problems arise, refer to the specific troubleshooting chapter Data alarms on
page D-3.
4 After you have carried out remedial actions, choose Delete.

The relevant alarm indication will disappear and the color of the Alarm will
return to its original state (blue).
5 Choose Close to close the Alarm screen.
Roche Diagnostics
System Overview screen
The System Overview screen plays a central role within the cobas c 311 analyzer
software. This screen provides the operator with an overview of the whole system at
any given time and the analyzer can be prepared for daily routine operation (via the
Work Flow Guide).
Figure B-30 System Overview screen
It is possible to call up the System Overview screen from any point of the
software—Workplace, Reagent, Calibration, QC, or Utility— by choosing this icon
in the top left corner of the screen or by pressing <F12>.
e For a list of all shortcut keys, see:
The Work Flow Guide area at the top of the System Overview screen guides you
through the preroutine operation.
The Overview area provides a view of the current status of the analyzer and
components of the cobas c 311 analyzer.
The lower section of the Overview area displays information relevant to the
component currently selected such as incubator temperature (INC.).
Before performing any measurements, check that the temperature of the

incubator is within 37C  0.1C.
o A wrong temperature may result in incorrect measurement results and lead to
incorrect results for the photometer check (maintenance item (2) Photometer Check).
o An alarm will be issued when the temperature reaches 37C  0.5C.
o Depending on the ambient temperature, it can take up to 30 minutes to reach the
correct temperature after switching on the analyzer or after exchange of incubation
water (maintenance item (4) Incubation Water Exchange).
Roche Diagnostics
Alarm This button displays the color corresponding to the highest priority alarm of the
currently selected component. Choose this button to display the global Alarm screen.
The alarm(s) corresponds to the component currently selected.
e See Check system alarms on page B-43.
e For a detailed description of the Alarm screen, refer to the Online Help.
Reagent Overview Choose this button to display an overview of the reagents currently loaded. This
button is only visible if you have selected AU (analyzer unit).
e See Reagent Overview button on page B-143.
Color scheme of the System Overview screen

The System Overview screen uses colors to display the status of the system. The color
scheme is different when preventive action is activated by selecting the Preventive
Action check box. The following table describes the meaning of the color scheme for
each button on the System Overview screen.
Colors in the Work Flow Guide
Figure B-31 Work Flow Guide area of the System Overview screen
Buttons in Work Flow Guide area Color Meaning
Daily Red A maintenance item is overdue.

Maintenance Yellow A maintenance item is almost due.
Sample Data Red The database is full (10 000 records). No additional samples can
Clear be processed until the hard disk is cleared.
Yellow The database is nearly full (more than 9400 records).
Reagent Red Reagent for at least one test or detergent required for the test is
Preparing not on board (mandatory) or is empty.
Yellow The number of tests remaining for a reagent, diluent, or wash
solution is below the yellow alarm threshold.
Purple The number of tests remaining for a diluent, test reagent or
detergent volume is less than the daily requirement - only
applicable if the Preventive Action check box has been selected.
Calibration and Yellow The system has recommended a calibration or quality control.
QC Select
Parameter Red A reagent, calibrator, or QC was loaded onto the analyzer, which
Download has not been installed before. New information for applications,
controls, and calibrators must be downloaded from cobas link.
Sample Blue This button is used to track samples, it does not change color.
Tracking
Table B-8 Color scheme Work Flow Guide area
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Colors in the Overview area
Figure B-32 Overview area of the System Overview screen
Buttons in the Overview area Color Meaning

Host, Core, and Control Unit Red An instrument alarm at the Stop, S.Stop or E.Stop level.
Yellow An instrument alarm at a caution level.
Maintenance).
Analyzer (AU and ISE) Red Indicates an instrument alarm at the Stop, S.Stop or E.Stop level
or that a reagent is empty and there is no second cobas c pack
placed on this analyzer.
Yellow Indicates an instrument alarm at a caution level or that the
number of remaining tests is below the yellow alarm level
threshold.(a)
Purple Indicates that the number of tests remaining for a diluent, test
reagent or detergent volume is less than the daily requirement(a) -
only applicable if the Preventive Action check box has been
selected.
Maintenance).
Red A reagent is empty and there is no second cobas c pack placed on
Reagent Overview
the analyzer.
Yellow The number of tests remaining for a reagent is below the yellow
alarm level threshold.(a)
Purple The number of tests remaining for a reagent is below the purple
alarm level.
Red Indicates an instrument alarm at the Stop, S.Stop or E.Stop level
Alarm
Yellow Indicates an instrument alarm at a caution level

Table B-9 Color scheme of the Overview area
(a) Specified on the Utility > System (Page 2/5) > Reagent Level Check window.
Roche Diagnostics
Work Flow Guide

Figure B-33 Work Flow Guide
The Work Flow Guide area consists of 6 buttons: Daily Maintenance, Sample Data
Clear, Reagent Preparing, Calibration and QC Select, Parameter Download, and
Sample Tracking. The first five buttons are placed in the suggested sequence of
preventive action. If a button is not highlighted, that action is not necessary.
The Sample Tracking button is used to search for samples on the analyzer. This is
possible at any time during operation as long as no samples have been removed from
the sample disk and no new run has been started.
e For more information about the meaning of the colors, see:
Color scheme Work Flow Guide area, Table B-8 on page B-45.
Preventive action
Preventive action is a look ahead at what might be required during daily routine
operation. When activated, preventive action triggers the following items:
o Reagent purple alarm
o Calibrate Now
At logon, the Preventive Action check box on the System Overview screen is
selected and therefore active.
For routine operation we recommend deselecting the Preventive Action check box
because it is not necessary to be informed about the triggered alarms.
Roche Diagnostics
Before you can start routine operation you must first prepare the system for
operation. Preroutine operation involves the following tasks:
o Performing maintenance actions
o Clearing and backing up data, if necessary
o Preparation of reagents, detergents and diluents
o Calibration
o Measurement of quality controls
o Download of parameters, if necessary
Daily Maintenance button
Requirements: Define The Daily Maintenance button indicates when maintenance intervals are about to
maintenance types expire. However this function is available only if maintenance intervals for
maintenance items are defined.
Color scheme Work Flow Guide area, Table B-8 on page B-45.
Maintenance types—scheduling and tracking maintenance items on page C-8.
Choosing Daily Maintenance on the Work Flow Guide area displays the
Maintenance screen. Use the Maintenance screen to execute maintenance actions or
maintenance pipe functions.
e See Performing maintenance items on page C-9.
Define a Power Up Pipe For a proper use of the analyzer Roche recommends performing some maintenance
items regularly. We recommend making these maintenance items automatic by
means of maintenance pipes.
e See Recommended maintenance pipes on page C-17.
o Daily maintenance items may be programmed as a Power Up Pipe and will then be
performed automatically when powering on or waking up the system.
o To backup the data of your analyzer to cobas link we recommend including the
maintenance item cobas link Essential Information Upload into the Power Up Pipe.
o The date of execution is updated each time a maintenance item is executed. It will be
updated even if operation is interrupted due to an alarm, etc. In this case, execute the
relevant maintenance item again and terminate it normally.
Power Up Pipe function on page C-14
Start Up Pipe function on page C-15
Roche Diagnostics
a To perform daily maintenance items and checks

1 After power-on, make sure that the daily maintenance items are executed by the
Power Up Pipe function, or perform them manually.
e See: Daily maintenance—at power on or start up on page C-37.
2 While the analyzer executes the Power Up Pipe, perform the visual checks as
described (with top cover closed).
3 When the Power Up Pipe is finished, perform the visual checks as described.
4 Choose the System Overview screen.
o Choose the Daily Maintenance button if it is yellow or red. Perform the
indicated maintenance items.
o Before starting analysis, check that the temperature of the incubator bath is
within 37C  0.1C.
5 Continue with the following preroutine steps.
Roche Diagnostics
Sample Data Clear button
Use the Sample Data Clear button to delete all measurement results of routine and
Stat samples. Less sample data on the hard disk allows faster access to the data.
Backing up on a periodic basis is recommended.
NOTICE Deleting patient results

Clearing the sample database deletes all patient results currently stored on the hard disk.
Any control results are moved to the QC view of data review.
o If your analyzer is connected to a Host, make sure that all data have been uploaded
before clearing the sample database.
o Back up all results when clearing the sample database.
Figure B-34 Sample Data Clear window
e See Archiving patient data on page B-106.
o Once the hard disk is full, no more sample data can be saved. In the System
Overview screen the Sample Data Clear button turns to red. To save further data,
the hard disk must be cleared.
o It is strongly recommended that a sample clear is performed daily to minimize the risk
of data loss.
e For more information, see Color scheme Work Flow Guide
Table B-8 on page B-45
If a sample is measured with the same sample ID or same number as an already measured
sample, the results will be displayed with the original sample number or ID.
Roche Diagnostics
Reagent Preparing button
Requirements: Define reagent The Reagent Preparing button indicates that insufficient amounts of reagent remain.
warning levels and mandatory However, this function is available only if the test counts (or volumes) for the reagent
tests level check and the mandatory tests were defined.
Define reagent warning levels The Reagent Preparing button changes its color to yellow or purple if the
corresponding alarm has been selected for one or more tests. Define reagent warning
levels for the yellow and purple alarm under Utility > System (2/5) > Reagent Level
Check for each reagent and detergent.
For the purple alarm, we recommend setting the volume of reagents to be used in one
day.
The purple alarm however, will only appear if the Preventive Action check box in the
System Overview screen has been selected.
Define mandatory tests The Reagent Preparing button changes its color to red if a reagent or detergent is
empty or if a reagent has been defined as mandatory and is not on board. Mandatory
tests are defined under Utility > Module Set > Test Assignment. Detergents and
diluents can not be defined as mandatory.
e For more information, see Color scheme Work Flow Guide:
Color scheme Work Flow Guide area on page B-45
Define reagent warning levels on page B-51.
Print Reagent Load/Unload List The Reagent Load/Unload List displays the cobas c packs and auxiliary reagents that
need to be replenished on the system.
a To print a Reagent Load/Unload List

1 Choose Reagent Preparing on the System Overview screen.
2 Choose Reagent Load/Unload List on the Reagent Preparing window.
A confirmation window appears.
3 Choose Yes to print the Reagent Load/Unload List.
Now, replace any required reagent, diluent, detergent, or wash solution according to
the Reagent Load/Unload List. Ensure that reagents have not exceeded their
expiration dates.
Roche Diagnostics
ISE reagents
The ISE auxiliary reagents (ISE IS, ISE Dil., and ISE Ref.) are stored in reagent bottles
in corresponding ISE reagent compartments.
Replace all required reagents as indicated on the Reagent Load List. Make sure to
place them according to their correct positions.
The analyzer must be in Maintenance mode (bright yellow status line) or shutdown
during replacement.
After replacement, the following steps must be performed:
1. Reagent level reset:
The volume must be reset under Reagent > Setting > Reagent Level Reset. For
ISE IS and ISE Dil., the remaining volume is then reset after the first reagent level
detection. This is automatically performed by the reagent probe before starting a
measurement.
2. Reagent prime:
After the replacement of ISE IS or ISE Ref., a Reagent Prime is required to fill the
flow path with the new liquid.
3. ISE calibration:
A changeover calibration will be requested in the Calibration Status screen.
ISE IS ISE Dil. ISE Ref.

Reagent level reset x x x
Reagent prime x - x
ISE calibration x x x
Table B-10 Required steps after replacement of ISE reagent bottles
e For more information about ISE reagents, see:

Reagents for ISE applications on page B-129
ISE reagent registration on page B-135
Notes on replacement of ISE reagents on page B-135.
page A-9
o Infection and injury due to contact with instrument mechanism on page B-3
o Incorrect results due to expired reagents or mixing reagents on page B-4
a To replace ISE IS or ISE Dil.

1 Put the analyzer in Maintenance mode or Shutdown status.
3 Place a new bottle into the reagent position. Make sure to place it in the correct
position.
4 Close the top cover of the analyzer and lock it.
5 Turn the maintenance switch back to Operation mode (or power up the analyzer
if it was in Shutdown status).
Roche Diagnostics
home positions.
7 Select the Reagent > Setting screen and select the reagent bottle that has been
replaced.
8 Choose Reagent > Setting > Reagent Level Reset and choose Yes.
A blank space is provided in the column Available Tests. The remaining volume
will be displayed after the first reagent level detection.
9 After replacing the ISE IS bottle, perform a Reagent Prime and an ISE calibration.
After replacing the ISE Dil. bottle, perform an ISE calibration.
e See To perform a Reagent Prime on page B-54.
e See To replace a cell detergent bottle on page B-141
a To replace ISE reference solution (ISE Ref.)

3 Remove the tubing from the ISE Ref. bottle and clean the ISE Ref. aspiration filter.
e See M9: Cleaning the ISE Ref. aspiration filter on page C-73.
4 Replace the ISE Ref. bottle, and place the tubing into the new bottle.
Make sure that the end of the tube touches the bottom of the bottle. Otherwise,
reagent may not be dispensed properly.
Incorrect results due to incorrect insertion of the ISE Ref. aspiration tube
If the aspiration tube is not inserted correctly, the reagent may not be dispensed
CAUTION properly. This may lead to incorrect results.
o Insert the aspiration tube so that the end of the tube touches the bottom of the
bottle.
o Do not bend the aspiration tube.

if it was in Shutdown status).
home positions.
8 Select the Reagent > Setting screen and select the reagent bottle that has been
replaced.
9 Choose Reagent > Setting > Reagent Level Reset and choose Yes.
After reset, an initial value of 279 ml is displayed in the column Available Tests.
10 After replacing the ISE Ref. bottle, perform a Reagent Prime and an ISE
calibration.
Roche Diagnostics
a To perform a Reagent Prime

1 Choose one of the following options to open the Reagent Prime window:
o Reagent > Setting > Reagent Prime
o Utility > Maintenance > maintenance item (7) Reagent Prime
o System Overview > Reagent Preparing > Reagent Prime
2 Choose Parameter on the Reagent Prime window.
3 Select the type of reagent to be primed (ISE Ref. and ISE IS) and choose OK.
4 Back in the Reagent Prime window, choose Execute.
The prime is complete when the system returns to Standby.
If you have replaced a reagent bottle, calibrate the ISE unit before you resume routine
operation.
e For details on the ISE calibration, see:
Calibration And QC Select button on page B-58
ISE calibration on page B-173.
a To request an ISE calibration manually

1 Make sure that the calibrators ISE Low, ISE High and ISE Comp. are on the
sample disk.
2 Choose Calibration > Status.
3 If there are entries in the Calib. Method column for ISE, continue with step 6.
Otherwise continue with the next step.
4 From the Test list, select ISE-A and ISE-B calibration curves (if both are
available).
5 Select the Full button in the Method area
6 Choose Save to save the changes.
The entries in the Calib. Method column are highlighted in green for all
requested tests.
e For details on how to start the ISE calibration, see:
To measure calibrators and controls on page B-62.
Roche Diagnostics
Loading cobas c packs

Replace all required photometric reagents and auxiliary reagents as indicated by the
Reagent Load List. Ensure that reagents have not exceeded their expiration date.
Incorrect results due to insufficient reagent volume

When using cobas c pack MULTI, it must be filled with the exact filling volume specified
CAUTION in the instructions for use in cobas link. If this is not the case, measurement accuracy may
deteriorate. Additionally, an alarm (reagent short) may occur if the analyzer detects that
the reagent volume is low.
o Ensure that the cobas c pack MULTI contains the correct filling volume. Refer to the
instructions for use in cobas link.
Loading cobas c packs It is only possible to load a cobas c pack when the analyzer is in Standby mode and
the applications have been downloaded from cobas link. Reagent registration takes a
few minutes as it includes piercing the cap and checking reagent volume.
The cobas c packs containing diluent for pre-dilution of samples, Hitergent for the
incubator water bath, and detergents for the reagent probe (NaOH-D and SMS) are
registered in the same way as other cobas c packs. For these solutions all relevant data
must be downloaded first from cobas link via Utility > Application > Download.
a To load a cobas c pack

1 Make sure that the analyzer is in Standby.
2 Choose Loading on the Reagent > Setting screen. The Cassette Loading window
opens.
3 Choose Execute. The analyzer turns the reagent disk to a free position and
unlocks the gate to the reagent loading station.
A Gate to the reagent loading station B Barcode reader

C Barcode label
Figure B-35 Scanning the barcode label on a cobas c pack
4 Open the gate to the reagent loading station.
Roche Diagnostics
5 Slide a cobas c pack with the barcode label facing to the right side past the barcode
reader.
6 If reading is successful, you will be asked to confirm the cassette information. If
reading is not successful, an alarm occurs.

CAUTION reagents will be pipetted in the wrong order, leading to incorrect results. The
instrument may also be damaged.
Problems occurring during scanning of barcode label

o If the barcode of a cobas c pack is facing the wrong way or the barcode is partly
covered by your fingers, the barcode information cannot be read and the
cobas c pack is not registered. Scan again.
o If the barcode label is unreadable an alarm occurs and the cobas c pack is not
accepted. In this case do not use this cobas c pack and close the gate.
7 Place the cobas c pack in the empty position on the reagent disk.
8 Close the gate covering the reagent loading station.
If the reagent disk cover is left open for more than ten minutes, an alarm will occur.
9 The contents of Cassette Information is now displayed in the window.

10 If there are multiple cobas c packs, steps 4 to 9 above must be repeated as
required.
11 After all cobas c packs are registered, click End.
Reagent registration is performed automatically when a new cobas c pack is
loaded. A manual reagent registration is not available. The analyzer automatically
registers all new cobas c packs and uses the reagent probe to physically check the
reagent level in each reagent bottle. Then, this initial reagent volume is counted
down with each pipetting.
Reagent registration on page B-136
Replacing auxiliary reagents e For instructions on how to replace auxiliary reagents, see:
Roche Diagnostics
Unloading cobas c packs

If you need space on the reagent disk for other reagents, cobas c packs can be
unloaded. Use the same procedure to unload empty reagents.
a To unload a cobas c pack

2 In the Reagent > Setting screen, select the cobas c pack that is to be unloaded
(you can also select multiple packs by using the <Ctrl> key on the keyboard and
selecting each pack).
3 Choose Unloading to open the Cassette Unloading window.
4 Choose Execute.
The reagent disk turns to the slot position of the reagent in the lowest numbered
position. The gate to the reagent loading station will be unlocked.
5 Open the gate and take out the cobas c pack.
6 Close the gate.
In case multiple cassettes have been selected, repeat steps 5 and 6.
7 After unloading all of the cobas c packs, choose End.
Roche Diagnostics
Calibration And QC Select button
It is necessary to calibrate all applications and measure quality control (QC) samples
regularly to verify the stability of reagents and the entire system. Make sure that
calibration has been completed successfully and that all QC results are OK before you
start routine operation.
Calibration and QC intervals vary from application to application and therefore each
application has its own configuration. In line with this configuration, the system
automatically recommends calibrations and QC measurements for all registered
applications.
Every time the system recommends a calibration this is indicated by the Calibration
And QC Select button turning yellow.
The following sections describe how to carry out a recommended calibration. The
instructions are based on the assumption that all calibration and QC configurations
have already been set.
e For general information on calibration, see:
Calibration concept on page B-151
Triggers for automatic calibration requests on page B-152
e For information on calibration settings, see:
Description of application parameters - Calib. tab on page B-224
To select tests for start-up group calibration on page B-158
e For information on QC settings, see:
To perform controls for active reagents on page B-186
To perform controls for standby reagents on page B-186
To perform QC after calibration on page B-187.
The entire calibration and QC process comprises the following parts:

1. Requesting calibration and QC and printing load lists.
2. Measuring calibrators and controls.
3. Validating calibration and QC results.
In the following each of these parts is described. However, some details may vary
depending on your laboratory’s choice of a specific calibration workflow (e.g., time-
triggered calibration or QC-triggered calibration).
Roche Diagnostics
Requesting calibration and QC and printing load lists

Use the Calibration And QC Select button to select the calibrations and QC to be
performed. Choose this button to display the Calibration And QC Select window,
from which calibration and quality controls are programmed and calibrator and QC
load lists can be printed.
Incorrect results due to expired calibrators or controls

Data obtained using expired calibrators or controls are not reliable.
CAUTION Do not use calibrators or controls that have exceeded their expiration dates.
Calibration or QC failure
If you have to manually assign a calibrator or QC container or other sample container—for
CAUTION example, due to an unreadable barcode—do not place any containers with barcodes in
manually assigned positions.
It is possible to do a calibration with a mixture of barcoded and non-barcoded calibrators.
However, you must assign the position of the non-barcoded calibrator and no position
should be assigned for the barcoded calibrator. If you put a barcoded container on a
position that was assigned manually, the calibration is not measured.
o Note that Hitachi micro cups are not applicable to calibrators and QCs.
o Before placing calibrators and controls in the sample disk, check that no bubbles or
foam are visible on the surface of the liquid.
o If you perform QC after calibration, QC samples do not have to follow directly after
calibrator samples. Other samples can be placed in between them.
Use the following procedure to request the recommended calibrations and controls.
If you need to select additional calibrations manually, select these from the
Calibration > Status screen.
e See Requesting and cancelling calibrations manually on page B-157.
Roche Diagnostics
a To request calibration and QC

1 Choose Calibration And QC Select in the Work Flow Guide area.
Figure B-36 Calibration And QC Select window
2 Choose the buttons that are yellow in both the Calibration area and the QC area
to select the recommended calibrations and controls for measurement.
In case there are reagents on board with less than ten tests remaining, a confirmation
window opens and it is possible to cancel the calibration/QC request for these
reagents.
3 Select the list you want to print from the Load List area:
o QC comprises all requested QCs including QC after calibration.
o Calibration comprises all requested calibrations.
4 Choose Print to print the selected Load Lists. The Calibrator and QC Load Lists
display all calibrators and controls that are necessary for performing the
requested measurements.
If you need to run QC for standby cassettes, do one of the following:

o Choose Stand By Bottle QC to request a QC for all standby bottles.
o Choose QC > Status > Stand By Bottle QC, select individual tests from the list,
and choose OK.
5 Load the calibrators and controls onto the analyzer as directed by the Calibration
load list and the QC Load List, see: To load required calibrators and controls on
page B-61.
Roche Diagnostics
QC Load List 07/07/31 11:12
-----------------------------------------System Specific Position--------------------------------
NAME LOT POS.NO.

HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
biorad 90909 C088
HBCP 67983300 C084
-----------------------------------------QC after Calib.-----------------------------------------

NAME LOT POS.NO.
HBCN 67553600 C083
PNP 17482100 C087
PNU 17349900 C081
PPU 17304300 C082
PN PUC 17601000 C085
PP PUC 17659900 C086
HBCP 67983300 C084
Table B-11 QC Load List report
Calibration Load List 07/07/09 10:39
NAME LOT Pos.NO.

CFA1C 17514200 S073
CFAS 17272700 S080
H2O 99999900 S079
C-PUC 17600900 S075
ISELOW 67873301 S068
ISEHIGH 67872901 S069
ISECOMP 17682800 S070
Table B-12 Calibration Load List report
e For more information about the different information on printouts, refer to the Online
Help of the particular report.
a To load required calibrators and controls

1 Using the load list as a guide, prepare all required calibrator and control materials
according to the manufacturer's instructions.
2 Load calibrators and controls onto the sample disk.
Roche Diagnostics
Measuring calibrators and controls

Once calibrations and QCs are requested and the calibrators and controls are placed
in the sample disk, the measurements can be started.
Calibration and QC is usually performed at the beginning of routine operation before
sample processing begins. However, it can be carried out anytime during routine
operation.
a To measure calibrators and controls

1 Make sure that the calibrator and control samples are loaded according to the
load list.
2 Choose Start (global button).
Figure B-37 Start Conditions screen (barcode mode)
3 Verify the settings on the Start Conditions screen.

Only when operating in non-barcode mode and if patient samples are already
onboard, enter the sequence number of the first patient sample to be analyzed
into the Start Sample No. text box. This number refers to the Sequence No. in
the Test Selection screen.
4 Choose Start on the Start Conditions screen. The Start Conditions screen closes
and the calibration and control run begins.
The sample disk rotates and checks to see if a position on the sample disk is
occupied. In barcode mode, each sample ID will be read.
If running barcoded calibrator or QC samples and the lot read is not installed, the
Parameter Download button on the System Overview screen turns red and the
samples are not run. Choose Parameter Download and download the necessary lot
number of the calibrators or QCs.
If automatic printout of calibration and QC is selected on Utility > System (Page 4/5) >
Automatic Printout, the Calibration Monitor and Control Result Monitor reports are
automatically printed when the measurements are completed.
Roche Diagnostics
Validating calibration and QC results

It is important to verify that calibrations and QC results are valid before measuring
routine samples. Validation can be performed either through the Host or on the
system. For routine operation it is sufficient to validate calibrations and QC by means
of the System Overview screen:
o A failed or newly recommended calibration is indicated on the System Overview
screen by the Calibration and QC Select button turning yellow.
e Detailed information on calibration results can be viewed on the Calibration > Status
screen, see:
Calibration Status screen on page B-156
Reviewing calibration data on page B-159.
e Detailed information on quality control results can be viewed on the QC > Individual
screen, see:
QC Individual screen on page B-190.
If the automatic printout of calibration or QC results is configured (under Utility >

System (Page 4/5) > Automatic Printout), it is possible to use these printouts for
validation, too.
If calibration or QC failed… In case a calibration fails or a QC result falls outside the expected range, check for QC
data alarms on the Workplace > Data Review screen and calibration alarms on the
printouts.
Data alarms are issued when measurement values or results are in any way unusual or
unexpected. Data alarms appear on screen and on reports as short strings also
referred to as data flags. Look up the meaning of each data flag and possible remedies
in the troubleshooting part of this manual.
e See Chapter 15 Data alarms.
After taking the necessary measures, repeat the calibration or QC before you begin
routine analysis.
If a realtime QC rule is violated, the system issues a realtime QC alarm. Make sure that you
check the results of the QC to see if the values are within the range.
Quality control results The results of QC measurements are saved in the database and displayed on the Data
Review screen as well as on the QC > Individual screen. QC can also be checked in
the Run Status screen instead of in the Individual QC screen.
It is important to regularly consolidate these results (by pressing the Accumulate
button) in order to generate long term quality control data (QC > Cumulative).
e For information on accumulation of control data, see:
Accumulation of QC measurement data on page B-181.
Roche Diagnostics
Parameter Download button
When the Parameter Download button is red, new parameters for applications,
calibrators, and controls must be downloaded from cobas link. Choose Parameter
Download in the System Overview screen to open the To Do List window.
e For an overview of downloading parameters from cobas link, see:
Loading or updating applications on page B-214.
a To download new information

1 Choose the Parameter Download button in the System Overview screen.
Figure B-38 To Do List window
2 Choose the tab corresponding to the item you want to download.

3 Select an item from the list and choose Download.
The corresponding screen will be opened, e.g. the Utility > Application screen
for application parameters.
4 Choose the Download button to open the Download window.
e The following steps are described in the corresponding chapters:

Loading application parameters on page B-215
Loading calibrator data on page B-167
Loading control data on page B-203
Sample Tracking button
The Sample Tracking window provides an overview of the samples in the sample
disk and allows the operator to search for samples which have already been registered
by the system.
Sample tracking is part of the routine workflow. Therefore, the Sample Tracking
window is described in the next section.
e See: Sample tracking on page B-72
Roche Diagnostics
Routine Operation
Routine Operation
After completing preroutine operation, you are ready to start routine operation.
Before continuing with routine operation, deselect the Preventive Action check box on
the System Overview screen. Otherwise, the system will issue purple and other irrelevant
alarms in the course of routine operation.
Routine operation involves the following items:

1. Processing routine samples
2. Processing STAT samples
3. Checking results and handling of data
4. Sampling Stop
The way in which routine operation works will vary depending on the following
system settings and sample properties:
o Whether routine or STAT samples are being analyzed
o Whether the analyzer is operating in barcode mode or not (set in the Barcode
Setting area under Utility > System)
o Whether the analyzer is operating in connection with a Host computer
o Whether the SBS mode is activated or not (for processing of open test requests)
o Infection and injury due to contact with instrument mechanism on page B-3
o Incorrect results and interruption of analysis due to contaminated samples on
page A-11
o Incorrect results due to evaporation of samples or reagents on page A-11
o Incorrect results due to carryover on page A-11
o Incorrect results due to position mismatch on page B-4
o Incorrect results due to missing covers of the ISE unit on page B-4
o Incorrect results due to aspiration of air on page B-4
Restrictions for the use of micro cups

Do not use micro cups for calibrators and controls.
Roche Diagnostics
Routine Operation
Processing routine samples
In this section, we describe the workflow for an analyzer that operates in connection
with a Host and is set to process routine samples in barcode mode. Processing
samples always includes the following steps:
1. Test selection
2. Loading samples
3. Starting the measurement
4. Checking the results
This includes to check for open test requests.
Test selection
Test selections for routine samples are usually downloaded from the Host. However,
these test selections may be changed manually—regardless of the mode (Standby,
Stop, Operation, or Sample Stop) the analyzer is in. When working without a Host,
the test selection must be entered manually.
e For information on manual test selections, see Requesting a test manually on page B-91.
Roche Diagnostics
Routine Operation
Loading routine samples

Once test selections have been made on your Host system or on the analyzer, put the
samples into the sample disk observing the notes below. If needed, print a requisition
list from Print (global button) > Workplace > Requisition List.
e For more details on printing the Requisition List, refer to the Online Help.
a To load patient samples

1 Prepare patient samples.
Personal injury due to touching moving parts

The green Access Sample Disk lamp next to the sample disk indicates that the sample
CAUTION disk will not rotate until renewed operation is actively initiated by the operator.
Only load samples when the green Access Sample Disk lamp is on.

When operating in non-barcode mode, make sure to load the samples to their
CAUTION registered positions. The registered tests and sequence numbers can be checked by
printing a Requisition list (Print (global button) > Workplace > Requisition List).
2 Load the patient samples onto the sample disk.
Make sure that you place samples on a permitted position.

Do not place barcoded samples on a manually assigned position.
A
max. 88 mm
A Sample tube (100 mm) C Barcode scan range

B Opening for barcode scanning
Figure B-39 Sample tubes on the outer ring with their barcode facing outwards
3 Ensure that the sample barcodes are facing the right way so the two barcode
readers can scan them. Samples placed in the inner ring must have their barcodes
facing inwards, samples placed in the outer ring must have their barcodes facing
outwards (see Figure B-39 on page B-67).
e For specifications of the correct position of the barcode label, see:
Scan range for sample barcodes on page A-79
Roche Diagnostics
Routine Operation
Starting the measurement

Before starting a run, ensure that all test selections have been made and all necessary
samples (calibrators and controls if requested) have been loaded.
a To start processing
Figure B-40 Start Conditions screen (barcode mode)
Figure B-41 Start Conditions screen (non-barcode mode)
2 Verify the settings on the Start Conditions screen.

When operating in non-barcode mode, enter the sequence number of the first
patient sample to be analyzed into the Start Sample No. text box. This number
refers to the Sequence No. in the Test Selection screen.
e For more information on setting the start conditions, see:
To activate the automatic rerun function (system-wide) on page B-96.
Roche Diagnostics
Routine Operation
3 Choose Start (on the Start Conditions screen).

The system performs a short preparation routine (approx. 5 minutes) and then
begins to process the samples. The sample disk rotates and checks to see which
positions on the sample disk are occupied. In barcode mode, each sample ID will
be read.
4 After the run, always check the Data Review screen for open test requests.
It may happen that some of the tests you requested could not be performed. These
open test requests (or open orders) may occur, for example, if you request
additional tests for a sample, or if a data alarm occurs while automatic rerun is
inactive.
e For information on checking the results, see:
To check for open test requests on page B-73.
e For information on additional test requests during a run, see:
To order additional tests in SBS mode on page B-101
To process additional samples during operation on page B-102
Interruption of measurements
If you press the Stop button or a serious red alarm stops the analyzer, then no results
will be calculated for already pipetted samples. Sample status will change to Masked
or Ordered. Eliminate the cause and restart the measurement.
Incorrect results due to exchange of sample positions during interruption

o When operating in barcode mode, do not exchange any samples highlighted in green
CAUTION on the Sample Tracking window.
o When operating in non-barcode mode, do not move or exchange any samples that are
already on the disk.
Roche Diagnostics
Routine Operation
Processing STAT samples
In this section, we describe the workflow for an analyzer that operates in connection
with a Host and is set to process STAT samples in barcode mode.
Reserve sample disk positions for STAT samples

o To ensure that a STAT sample can be processed immediately, reserve a certain number
of positions on the sample disk for STAT samples in the Sample Disk Setting window
(Utility > System (3/5) > Sample Disk Setting).
o If Patient ID is selected for the barcode mode, assign each of the sample type
positions for routines and STATS. This is performed on the Utility > System screen by
choosing the Change button in the Position Assignment area.

Using patient IDs on page B-238
Sample Disk Setting button on page B-245
Test selection
Test selection for STAT samples is the same as for routine samples. That is, test
selections for samples are downloaded from the Host in realtime but may still be
changed from the analyzer’s control unit.
e For information on changing test selections, see Requesting a test manually on page B-91.
Loading STAT samples

Once test selections have been made on your Host system or on the analyzer, load the
STAT samples onto the analyzer observing the notes below.
a To load STAT samples

1 Prepare the STAT samples.
To verify the correct sample positions for each STAT sample type, refer to the
Position Assignment area on the Utility > System screen.
You can check the Sample Tracking window for reserved STAT positions in both
Patient ID mode and barcode mode (Sample ID mode).
2 Continue as described in To process additional samples during operation on

page B-102.
Roche Diagnostics
Routine Operation
Checking results and handling of data
As results are generated on the instrument, they are saved in the database located on
the internal hard disk of the control unit. When all the test results requested for a
particular sample are available, the analyzer sends them to the Host where they can be
validated (automatic Host communication is activated by default).
Figure B-42 Data Review screen (barcode mode)
Status of results To view or edit results on the analyzer, use the Workplace > Data Review screen; all
test results in the database are displayed here.
The St. column on the left side displays the status of each sample:
O (Ordered) Sample registered by user or Host.

P (Processing) Sample is being processed.
I (Incomplete) Sample is measured, but a data flag is present.
No symbol (Complete) Sample successfully processed (no alarm present).
H (Sent to Host) Sample results have been sent to the Host.
e For a detailed description of the Data Review screen, refer to the Online Help.
Data Review screen on page B-105
Archiving patient data on page B-106
Editing or deleting sample data on page B-107
Tracking samples on the analyzer on page B-111
When checking results, it may become necessary to locate a certain sample for further
inspection. If a sample is still on the analyzer, use System Overview > Sample
Tracking to locate it.
Roche Diagnostics
Routine Operation
Sample tracking
In the Sample Tracking window, the analytical status of each sample in the sample
disk is displayed.
Figure B-43 Sample Tracking window
The Sample Tracking window provides an overview of all samples in the sample
disk. The Track Sample area on the right side of the screen displays detailed
information about each sample in the sample disk.
Position status The following statuses are displayed in the Sample Tracking window:
Empty The sample position is empty.
Cup Present A cup is present in this position but no request has been made or
no process has been started.
Processing The sample is being processed.
Completed Sample is complete with no flags.
Wrong A sample whose ID is duplicated in barcode mode.
Failed The result is outside the measurement range, the measurement

result contains one or more data alarms, or if a test is masked, or
sample mismatch has occurred.
Sample Error Sampling could not be performed for this sample due to one of
the following reasons:
o Sample volume is too low
o Sample clot
If an alarm sample short or sample clot occurs, all subsequently
ordered tests for this particular sample and automatic rerun are
canceled. A manual rerun is required.
Barcode Error The barcode is unreadable (displayed in barcode mode only).

Refer to the Online Help of the particular window.
Roche Diagnostics
Routine Operation
Checking for open test requests

After a run has been completed, you may find that some of the tests you requested
could not be performed. These open test requests (or open orders) may occur, for
example, if you request additional tests for a sample, or if a data alarm occurs while
automatic rerun is inactive.
With SBS mode If the SBS mode function is activated, the sample database is scanned for open test
requests after a run (SBS = scan before sample stop). This allows the analyzer to
process open test requests automatically in most cases. In some exceptional cases,
however, intervention by the operator may still be required.
e For detailed information, see: Open test requests (with SBS mode) on page B-113.
Without SBS mode If the SBS function is not activated, open test requests will require operator
intervention. You must check each open test request and eliminate the cause before
the open test request can be processed. Therefore we strongly recommend using the
SBS mode.
e For detailed information, see: Open test requests (without SBS mode) on page B-114.
a To check for open test requests

1 After a run, the following Confirmation window may appear.
This window does not appear if the SBS mode is active or if additional tests were
requested via the host (e.g., reruns, 3rd results).
Additional tests requested by the host are not indicated in the analyzer software.
Information about additional tests to be measured must be provided by the host.
Figure B-44 Confirmation window
Do not remove affected samples from the disk

o Do not remove samples from the sample disk for which there are open or
additional test requests.
o Identify and eliminate the cause first.
2 Choose OK to close the window (if present).

3 Whether a Confirmation window was displayed or not, always check for open
test requests.
4 Choose Workplace > Data Review.
o Check for samples which have the status Ordered (O) in the status (St.)
column. This status would indicate open test requests.
o Check these samples if any data alarms are displayed.
Roche Diagnostics
Routine Operation
5 Choose System Overview > Sample Tracking.

o Check for samples which have the status Cup Present (light blue) in the status
(St.) column.
o Check for samples with status Failed, Sample Error, or Barcode Error.
6 Identify and eliminate the cause of the open test request using Table B-13.
If no such samples can be found, all test requests have been performed
successfully.
Checks Cause of open test requests Remedies

With SBS mode:
A m Check Data Review screen for samples with A rerun was ordered but could not be e To process open test requests
status Ordered (O). performed automatically (auto-rerun is that could not be processed
inactive; or the specific data alarm does not automatically on page B-75
invoke an auto-rerun).
B m Check Sample Tracking window for An incorrect sample ID or Application e To process samples not
samples with status Cup Present. Code No. (ACN) was sent via host; or no measured yet on page B-75
tests were requested for a sample.
Without SBS mode - without a confirmation window:
C m Check the host software for additional test Additional tests were requested by the host o Check host settings.
requests. during a run. Additional requests should
Note: The status Ordered (O) is not indicated not be sent during a run.
on the Data Review screen.
Without SBS mode - with a confirmation window:
D m Check Data Review screen for samples with Additional samples were requested via the e Processing open test requests
status Ordered (O). analyzer software. (without SBS mode) on
page B-76
E m Check Data Review screen for any data Sample Short (Samp.S) or Sample Clot o Check alarm description.
alarms. (Samp.C) occurred; or another data alarm e Data alarms on page D-3,
occurred (e.g., <Test) and auto-rerun is Rerun list on page D-47
inactive.
F m Check Start Conditions > Masking. The test could not be performed because o Unmask the test.
test or patient masking is active.
G m For all applications: Check Utility > System The calibration of this test has failed and o Perform a new calibration
(Page 2/5) > Calib Mask setting. automatic calibration masking is active. or reject the failed
m For each test: Check Utility > Application > calibration.
Calib.
H m Check Sample Tracking window for Cup An incorrect sample ID or Application o Correct the sample ID or
Present indicated in blue. Code No. (ACN) was sent via host; or no ACN.
m Check for yellow alarms: Host receiving Text tests were requested for a sample. o Enter test selection or send
error, or Host communication Error. it via batch manually from
m Check Data Review screen if tests are listed. host.
Table B-13 Causes of open test requests
7 In non-barcode mode, note the sequence number (S. No.) of the affected samples.
Do not change the disk position of these samples.
8 After performing the remedy, perform the corresponding procedure described on
the following pages.
e Processing open test requests (with SBS mode) on page B-75
Processing open test requests (without SBS mode) on page B-76.
Roche Diagnostics
Routine Operation
Processing open test requests (with SBS mode)

In a few exceptional cases, open test requests cannot be processed automatically in
SBS mode and the status Ordered or Cup Present remains after the run.
a To process open test requests that could not be processed automatically

1 If there are Ordered samples without results, perform the following checks and
remedies:
o Check the Workplace > Data Review screen for data alarms which do not
cause an automatic rerun (Cal.E, ClcT.E, >Index, Mix.E, Reag.S, Samp.C,
Samp.S).
Perform the remedies described in chapter Data alarms of the Operator’s
Manual.
o Check that test-specific auto rerun is active. Choose Utility > Application >
Range for the specific test.
2 When the cause of the open test request has been eliminated, choose
Workplace >Test Selection.
3 Ensure that the instrument is in Sampling Pause or Sampling Stop status.
4 Choose Rerun Assignment and select the sample that need to be rerun. Enter the
test selection on the Test Selection screen.
Alternatively, you may move the affected sample to another position on the
sample disk.
5 Choose Start (global button) and start the analysis.
The analyzer scans the sample disk and processes the samples entered in the
manual rerun list. Ordered tests are measured as in normal operation.
a To process samples not measured yet

1 If there are samples indicated by Cup Present, perform the following checks and
remedies:
o Check and correct the sample ID or the Application Code Number (ACN)
that was sent from the host.
o Choose Alarm (global button) and check for yellow alarms. If a Host
Receiving Text error or Host Communication error occurred, check the
entered test requests made in the host program or the host connection,
respectively.
o Check Data Review screen. If no tests are listed for this sample, manually
enter the test selections through Workplace > Test Selection.
2 Ensure that the instrument is in Sampling Pause status.
3 Remove the affected sample from the sample disk and place it in a new position
on the disk. By changing the disk position, the test selection will be requested
again from the host after reading the barcode label.
4 Choose Start (global button) > Start to restart the measurement.
All samples with open test requests are processed. No further action is required.
Roche Diagnostics
Routine Operation
Processing open test requests (without SBS mode)

Open test requests can be processed either from Standby, Sampling Stop, or Sampling
Pause status.
Barcode mode For barcoded samples, you have the following options:
o Move the sample to another position.
e See To restart measurement (barcode mode) on page B-76.
o Perform a manual rerun.
e See Requesting manual reruns (barcode or non-barcode mode) on page B-100.
a To restart measurement (barcode mode)

1 Make sure the cause of the open test request is eliminated.
2 Remove the affected sample from the sample disk and check the sample container
visually for sample clot or sample short.
3 Place the sample into a new position on the disk.
All samples with test requests are processed. No further action is required.
Notes
o If the analyzer is in Standby, open or additional requests are performed
automatically when you restart measurement. The position of the affected samples
may be changed (or you can leave them in their original position). All samples with
test requests will be processed, not only those samples that were not measured
during the previous run.
o If the analyzer is in Sampling Stop (Sample Reception) or Sampling Pause
status, the position of the affected samples must be changed before you press
Start. Repositioned samples will be measured after all other samples are processed.
Non-barcode mode Depending on the status, you have the following options:
status, perform a manual rerun.
e See Requesting manual reruns (barcode or non-barcode mode) on page B-100.
o If the analyzer is in Standby, the sequence number must be changed before you
press Start.
e See Restart measurement from Standby (non-barcode mode) (5) on page 120.
Roche Diagnostics
Routine Operation
Sending data to the Host

If results have been edited or if automatic Host communication is deactivated, always
make sure to choose the Send To Host button. You can select multiple test results
and transmit them collectively.
If an automatic rerun is performed, the results for the original test and the rerun are
reported separately to the Host.
To check whether the automatic Host communication is activated or not, choose the
Result Upload Setting tab on the Utility > System (Page 1/5) > Host
Communication Setting window (available in administrator level only).
Archiving data and performing data backups

The analyzer software manages several types of data and provides the following
storage routines.
Data type Storage routine Target To be performed

Test results Sending/Archiving after a) to Host automatically (or manually via Workplace > Data Review >
(patient data) measurement Send To Host)
b) to a DVD via Workplace > Data Review > Backup Data, or
via System Overview > Sample Data Clear > Backup And
Clear
Important data, Backup function to cobas link via cobas link Essential Information Upload
configurable(a) (daily) data station (performed automatically by a Maintenance Pipe)
System parameters Backup after to a floppy disk via Utility > Maintenance > Parameter Read/Write
(re)programming
Reports Backup after printing to a floppy disk via Print > View > Backup Disk Write
or DVD
Figure B-45 Overview of data types and possible storage routines
(a) The data types to be stored on cobas link data station are configured by Roche service personnel during installation (e.g., calibrator and control
data).
NOTICE Data loss due to erroneous operation or instrument troubles

Back up your data (measurement results and system parameters) at regular intervals.
Roche Diagnostics
Routine Operation
a To minimize the risk of data loss, perform the following routines:

1 Make sure that all test results are archived on the Host or make a backup copy on
a DVD.
e For more information about backups, see
2 We recommend using the backup function in a daily maintenance pipe to store

relevant data on the hard disk of the cobas link data station.
cobas link Essential Information Upload on page C-27
3 Make a backup copy if you have changed any system parameters (e.g., application
parameters, see Table B-37 on page B-266).
Saving system parameters on page B-265
Roche Diagnostics
Routine Operation
Printing sample information

It is possible to print out sample information from the database if needed. The Data
Print report displays all test information about a particular sample ID (for example
tests performed and the results).
a To print a Data Print report

2 Select a single sample, a range of samples or nonconsecutive samples to be printed
from the sample list on the left side of the screen.
3 Choose Print (global button).
Figure B-46 Workplace Print screen
4 Choose Data Print in the report list.

5 Select the desired print format, Monitor or Report, from the Print Format area.
6 Select the appropriate run type, 1st, Rerun, Both or Chosen, from the Run Type
area.
7 Choose All in the Print Data area to print all results on the currently selected
sample(s) or choose Edited to select printing of only edited results of the
currently selected sample(s).
8 You can display the currently selected report on the screen without printing or
you can print the report:
o To display a preview of the currently selected report, choose Preview and then
View.
o To print the report, choose Print.
For STAT samples, the results will be printed automatically if automatic printout of
Emergency Samples is selected on Utility > System (Page 4/5) > Automatic Printout.
e For more information about the different information on printouts, refer to the Online
Help of the particular report.
Roche Diagnostics
Routine Operation
Sampling Stop
After all test requests are completed, sampling stops. After the last result is calculated,
the system remains in Sample Reception mode for a set period of time. This time
period is set in Utility > System > Sample Reception area. Thereafter, the entire
system goes into Standby.
The period of time that is to elapse before the analyzer switches from operation to
Standby mode is defined under Utility > System. A time must be entered in the
combo box to specify the interval between starting operation and Standby. If the
Sample Reception Mode is disabled in the Start Conditions screen, the system goes
into Standby immediately after the last result is calculated.
Roche Diagnostics
Shutting down the analyzer
This section discusses the tasks to be performed at the end of analysis. It gives a
detailed description of the shutdown including both complete shutdown and sleep
mode.
Maintenance before shutdown
At the end of routine operation, it is important that all required maintenance is

performed. In addition to routine daily maintenance, this may also include other
scheduled maintenance—for example, weekly and monthly maintenance.
e For information about maintenance items to be performed, refer to your laboratory
maintenance schedule and see the following maintenance chapters:
Chapter 13 General maintenance
Chapter 14, Maintenance schedules on page C-33
Analyzer shutdown and sleep mode
After routine operation is finished and all required maintenance has been performed,
the analyzer can be shut down. There are two options for analyzer shutdown:
o Complete shutdown
o Entering sleep mode
Shutdown In Shutdown status the analytical unit and the control unit are powered off. Only the
power for keeping reagents cooled is supplied.
Sleep mode During sleep mode most of the parts are powered off. Only the control unit, cooling
compartment and control board are powered on. The monitor is automatically
powered off to reduce power consumption when it is not used for a fixed period of
time. Move the mouse to wake up the monitor.
Sleep mode provides the possibility of an automatic start-up on the next day. This
way, the system can perform initialization and any programmed start up
maintenance items in the absence of an operator, before the beginning of a working
session. When the operator arrives, the analyzer is ready for operation.
Note that when the analyzer wakes up from sleep mode, the control unit performs a
shutdown to reset the PC operation software (Windows XP).
e For more information about checks after waking-up from sleep mode, see:
Start-up inspection on page B-38.
Perform one of the following procedures to shut down the analyzer after all required
daily maintenance has been performed.
e For information about the daily maintenance items that must be performed before
shutdown, see:
Daily manual maintenance on page C-38.
Sleep mode can be entered manually or automatically after a maintenance pipe.
Roche Diagnostics
a To enter sleep mode manually

1 Choose Shut down (global button) to display the Shutdown window.
2 Select the Sleep option and choose OK.
The analyzer goes into sleep mode until the specified wake up time. The wake-up
time is displayed.
3 Check that the monitor is powered off.
4 Perform the regular checks after shutdown.
a To enter sleep mode automatically using a maintenance pipe

1 Verify the settings for the Sleep pipe function (Utility > System (Page 2/5) > Pipe
Setting).
e See Sleep Pipe function on page C-16.
2 If the maintenance item ISE Wash is included in the sleep pipe, make sure that
Sample Cleaner 1 and the cups with Activator and SysClean are on board.
3 Choose Utility > Maintenance and execute the pipe (e.g., daily sleep pipe).
The analyzer goes to sleep mode as soon as the pipe is finished.
4 Perform the regular checks after shutdown.
The complete shutdown procedure should be performed at least once a week.
Roche Diagnostics
Wake up after sleep mode Wake up can be programmed to a set time using the Power Up Pipe function. Of
course you can also wake up the analyzer manually at any time.
In case a Wake Up Time is set, a maintenance pipe can be performed automatically
after wake up.
e See Power Up Pipe function on page C-14.
a To shut down the analyzer

1 Choose Shut down (global button) to display the Shutdown window.
2 Select the Shutdown option and choose OK to confirm the shutdown.
3 Wait until the screen goes completely black (computer has shut down).
4 Switch off the power switches of the monitor and printer.
If power to the analyzer is switched off prior to the complete shutdown of the
computer, the instrument may not start up properly when power is supplied again.
5 Switch off the power switch on the right side of the analytical unit.
6 Turn off the water supply, if necessary.
After shutting down the analyzer, check individual parts of the instrument according
to the given maintenance recommendations.
e See Checks after shutdown on page B-84.
Roche Diagnostics
Checks after shutdown
The checks and maintenance actions required after shutdown are the same as those
required before start-up.
e See Start-up inspection on page B-38.
If the analyzer has been set for automatic start-up, it is essential to perform all
required maintenance actions either at the beginning or the end of each working
session working session.
e See Overview of daily maintenance schedules on page C-34.
Below is the list of conditions that are to be checked before start-up. Check that:
Control unit o There is no floppy disk in drive A.

o There is sufficient paper in the printer.
Analytical unit o The water supply is switched on.

o The container for highly concentrated waste is empty.
o There are no samples in the sample disk.
o All surfaces are clean and clear of loose articles. Clean up spills immediately using
a paper towel moistened with alcohol.
o No tubing is pinched or bent.
Either before shutting down or after powering up, check that:
o Syringes are not leaking.
o Auxiliary reagents (cleaning solutions) required for start-up pipes are loaded.
o All empty reagents are removed and new ones loaded according to your daily
workload.
ISE unit o All electrode cables and tubings are correctly connected. Tubing is not leaking.
If a trouble occurs, take suitable measures according to the condition and contact
your Roche service representative.
Roche Diagnostics
cobas c 311 analyzer 7 Orders and results
Table of contents
Orders and results
This chapter provides descriptions of special tasks that are not usually part of the
daily workflow. It is meant to complement the chapter Daily operation, where
everyday tasks and common procedures for running the cobas c 311 analyzer are
described.

Overview .......................................................................................................................... B-87
Test Selection screen ...................................................................................................... B-88
Test selection matrix ................................................................................................ B-89
Colors .................................................................................................................. B-89
Markings ............................................................................................................. B-90
Requesting a test manually ..................................................................................... B-91
Requesting a test in barcode mode .................................................................. B-91
Requesting a test in non-barcode mode ......................................................... B-93
Processing reruns ..................................................................................................... B-95
Automatic reruns ............................................................................................... B-95
Manual reruns .................................................................................................... B-96
Reruns with changed sample volumes ............................................................ B-97
Prediluted samples ............................................................................................. B-98
Performing manual reruns ..................................................................................... B-98
Manual reruns in barcode mode ..................................................................... B-99
Manual reruns in non-barcode mode ............................................................. B-99
Requesting manual reruns (barcode or non-barcode mode) ................... B-100
Extended sample processing ............................................................................... B-101
Processing additional tests ............................................................................ B-101
Processing additional samples ...................................................................... B-101
Entering unreadable sample barcodes ............................................................... B-103
Data Review screen ..................................................................................................... B-105
Archiving patient data .......................................................................................... B-106
Editing or deleting sample data .......................................................................... B-107
Displaying archived patient data ........................................................................ B-110
Tracking samples on the analyzer ...................................................................... B-111
Roche Diagnostics
7 Orders and results cobas c 311 analyzer
Table of contents
Open test requests ....................................................................................................... B-112

Open test requests (with SBS mode) .................................................................. B-113
Configuration of SBS mode ........................................................................... B-113
SBS basic functionality ................................................................................... B-113
Workflows when using SBS mode ................................................................ B-114
Open test requests (without SBS mode) ............................................................ B-114
How to proceed with open test requests ..................................................... B-116
Identifying the cause of open test requests (1) ........................................... B-117
Identifying additional test requests (2) ........................................................ B-118
Processing open test requests (without SBS mode) ......................................... B-119
Restarting measurement (barcode mode) (3) ............................................. B-119
Manual rerun (4) ............................................................................................ B-119
Restart measurement from Standby (non-barcode mode) (5) ................. B-120
General pipetting priority .......................................................................................... B-121
Preparing a DVD disk ................................................................................................ B-122
Formatting a disk .................................................................................................. B-123
Making a disk compatible .................................................................................... B-125
Roche Diagnostics
Overview
Overview
The following sections describe tasks and data that can be accessed by the screens
under the Workplace menu. The Workplace menu comprises two screens: The
Workplace > Test Selection and the Workplace > Data Review screen.
Workplace > Test Selection Use this screen to enter test selections and demographics for a sample. The available
screen fields for sample identification vary, depending whether STAT or routine test
selections are being entered and whether the analyzer is operating in barcode mode
or not.
e For information on special operation procedures, see:
Requesting a test manually on page B-91
Entering unreadable sample barcodes on page B-103
Workplace > Data Review Use this screen to perform tasks related to reviewing and editing routine and STAT
screen results. Control results can also be viewed here. Other tasks that can be performed
from this screen include editing demographic information, sending data to the Host,
deleting data individually or in batches, backing up data and editing data.
Displaying archived patient data on page B-110
e For a complete description of all fields and commands under the Workplace menu, refer
to the Online Help.
Roche Diagnostics
Test Selection screen
To display this screen, choose Workplace > Test Selection.
Figure B-47 Test Selection screen
Use this screen to enter test selections and demographics for a sample. The available
fields for sample identification vary, depending whether STAT or routine test
selections are being entered and whether the analyzer is operating in barcode mode
or non-barcode mode.
Fields Barcode mode Non-barcode mode

(sequence mode)
Routine Stat Routine Stat
Sequence No. – – l –
Disk Pos. – – l l
Sample ID l l l (a) l(a)
Table B-14 Test Selection screen - available fields for sample identification
(a) Recommended, but not required.
If test selections are downloaded from a Host, this screen is commonly not used.
e For more information about the different sample information fields and the buttons on
this screen, refer to the Online Help of the particular field or button.
e For information about the test selection matrix, see Test selection matrix on page B-89
Requesting a test manually on page B-91
Entering unreadable sample barcodes on page B-103
Sample Type Serum/plasma, urine, CSF, supernatant, other

o CSF: Use this sample type for cerebrospinal fluids.
o Supernatant: Use this sample type for whole blood and other supernatants.
o Other: This sample type is designed only for especially programmed applications.
Roche Diagnostics
Test selection matrix
A maximum of 160 test keys can be programmed on the analyzer. The test matrix has
32 keys in each group and up to 5 groups of test keys can be programmed on
Utility > System (Page 1/5) > Key Setting. One group at a time is displayed on the
Test Selection screen. Use the tabs above the test matrix to switch between the
groups. Group names are defined under Utility > System (Page 1/5) > Key Setting.
e For more information about Key Setting, refer to the Online Help.
Figure B-48 Test selection matrix
Colors
The test keys display different colors to indicate the status of the test for the sample
ID displayed in the Sample ID text box. The following colors are available:
This test has been selected.
This test has been performed, a result is available, and can be ordered again.
A rerun has been performed for this test and the result is available.
Roche Diagnostics
Markings
One test or profile can be assigned to each key. The test keys display special markings
depending on the test's status or programming. The different markings and their
meanings are outlined below:
Blank test key indicates no test is assigned.
Normal test key for a test or profile without any masking indicators. The
reagent is on board of the analyzer and registered.
Mask (test channel or patient samples are masked)
o Test manually masked on the Masking window (Start (global button) >
Masking > T-Mask)
o Measurement of patient samples is manually masked (Start (global
button) > Masking > P-Mask). However, calibrations and controls can
be performed.
o The test can be requested. However, the test is performed only after the
test is manually unmasked.
o The test is not assigned to the analyzer in Utility > Module Set.
Reagent mask (no reagent available)
o Test is automatically masked by the analyzer. The volume of reagent, or
detergent, that is required for the respective test is either insufficient or
the reagent is not present on the analyzer. The test can be requested;
however, the test is performed only if a new reagent or detergent is placed
on the analyzer (e.g., Sample Cleaner 1, when a special wash is
programmed, see Special Wash on page B-255).
Calibration mask (calibration failed)
Test is automatically masked by the system if no valid calibration is available
and the test requires a calibration.
The purple bar will not be displayed on the test key if:
o Calibration auto masking setting for the individual test is not selected on
Utility > Application > Calib.
o Calibration auto masking setting for the analyzer is not selected on
Utility > System (Page 2/5) > Calib Mask Setting.
Increased sample volume
o Test will run with an increased sample volume.
Decreased sample volume
o Test will run with a decreased sample volume.
Dilution
o Test will run with a dilution. The number after the triangle indicates the
ratio of the dilution (for example, 3 is 1:3).
Profile
o A brown bar on the key indicates the key has been assigned to a profile.
When selected, all tests assigned to that profile are highlighted.
o If the reagent for a test is not on board, the corresponding test key is marked with
reagent mask and calib. mask.
o If a diluent for a test is insufficient, this test will not be performed. However, the
corresponding test key is NOT marked with a red bar. The test will only be marked with
a "M" in the Status column of the Test Review window (M status flag).
Roche Diagnostics
Requesting a test manually
Tests can be manually selected for STAT and routine samples when the analyzer is in
either barcode or non-barcode mode.
This manual procedure is necessary if the test selection is not received from an
external system (host).
Requesting a test in barcode mode
a To request a STAT or routine sample

1 Load the sample onto the sample disk.
2 Choose Workplace > Test Selection.
3 Select the Stat or Routine option from the Sample area on the top left of the Test
Selection screen.
4 Make sure the Type list box is set according to the sample type.
5 Type in the barcoded sample ID into the Sample ID text box and press <Enter>.
The Pre-dilution check box is active.
6 Select the Pre-dilution check box if the sample has already been diluted and press
<Enter>. The cursor moves to the Sample Cup box.
Samples which have been manually prediluted can be measured, but the
corresponding dilution factors are NOT taken into consideration when the results are
calculated by the analyzer. It is the operator's responsibility to calculate the final
results.
7 Select the sample container type and press <Enter>. The cursor moves to the
Sample Volume / Dilution box.
8 Select the necessary dilution, if any, for the sample and press <Enter>. The cursor
moves to the test key.
o Application-specific dilutions are performed automatically by the system.

o Not all dilution ratios are available.
o If you choose a dilution ratio in the S. Vol./D.Ratio field, this selection will
overwrite the pre-programmed dilution ratio indicated in the Utility >
Application > Analyze screen.
If for example the test has a pre-programmed dilution ratio of 1:5 and you select a
dilution ratio of 1:3 for S. Vol./D.Ratio, the test is processed with a dilution of 1:3.
o If the sample volume of a test is higher than 20 L, a manual dilution request is not
accepted and a pop-up window is displayed.
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9 Select the test, combination of tests, or test profiles for the sample. Selected tests
and profile keys appear white.
10 If necessary, type in demographic information about the sample and the patient,
such as the draw date, the sex and the age, and a comment in the Demographics
window.
11 Choose Save to save the test selection.
Completing the test selection for all samples, continue with To check and correct
registered tests and to start analysis on page B-92.
a To check and correct registered tests and to start analysis

After all test selections have been registered, we recommend checking the test
selection. For routine samples, the Requisition List can be used for this purpose.
1 Print the Requisition list (Print (global button) > Workplace > Requisition List)
or check the registered tests on the screen as described in the following.
2 In the Test Selection screen, type in the sample ID number of the first sample in
the sample ID text box.
3 Check the registered tests:
o Choose Next to display the next sample without correction.
o Or correct the selected tests. Choose Save to save the corrected test selection.
4 Repeat the previous procedure up to the last sample to be checked.
5 Start analysis.
e For information on start of analysis, see
Starting the measurement on page B-68
Roche Diagnostics
Requesting a test in non-barcode mode
a To request a STAT or routine sample

1 Load the sample onto the sample disk.

When operating in non-barcode mode, make sure to register the samples according to
CAUTION the loaded positions. The registered tests and sequence numbers can be checked by
printing a Requisition list (Print (global button) > Workplace > Requisition List).

3 Select the Stat or Routine option from the Sample area on the top left of the Test
Selection screen.
4 Make sure the Type list box is set according to the sample type.
5 When requesting routine samples, type in the sequence number for the sample in
the Sequence No. text box and press <Enter>. The cursor moves to the Disk Pos.
text box.
6 Type in the position for the sample in the Disk Pos. text box and press <Enter>.
The cursor moves to the Sample ID text box.
7 Type in the sample ID into the Sample ID text box (recommended) and press
<Enter>. The cursor moves to the Pre-dilution check box.
8 Select the Pre-dilution check box if the sample has already been diluted and press
<Enter>. The cursor moves to the Sample Cup box.
Samples which have been manually prediluted can be measured, but the
corresponding dilution factors are NOT taken into consideration when the results are
calculated by the analyzer. It is the operator's responsibility to calculate the final
results.
9 Select the sample container type and press <Enter>. The cursor moves to the
Sample Volume / Dilution box.
10 Select the necessary dilution, if any, for the sample and press <Enter>. The cursor
moves to the test key.
11 If necessary, type in demographic information about the sample and the patient,
such as the draw date, the sex and the age, and a comment.
12 Select the test, combination of tests, or test profiles for the sample. Selected tests
and profile keys appear white.
13 Choose Save to save the test selection.
Completing the test selection for all samples, continue with To check and correct
registered tests and to start analysis on page B-94.
Roche Diagnostics
a To register a specific test selection to multiple samples

This option is only available in non-barcode mode.
1 Carry out all steps in one of the two previous procedures.
2 Choose Repeat to open the Repeat Test Selection window.
Figure B-49 Repeat Test Selection window
3 Type in the number of samples for repeating the test selection in the Repeat
Count text box.
4 Choose OK.
In the Repeat operation, demographic data are not copied. When the demographic data
are necessary, they have to be entered with each sample ID after collective entry.
a To check and correct registered tests and to start analysis

When operating in non-barcode mode, you must confirm that all samples are loaded
to their registered positions.
1 In the Test Selection screen, note the first sequence number from which analysis
is to be started. This number must be entered into the Start Conditions screen.
2 Print the Requisition list (Print (global button) > Workplace > Requisition List)
or check the registered tests on the screen as described in the following.
3 In the Test Selection screen, type in the first sequence number in the Sequence
No. text box.
4 Check the registered tests:
o Choose Next to display the next sample without correction.
o Or correct the selected tests. Choose Save to save the corrected test selection.
5 Repeat the previous procedure up to the last sample to be checked.
7 Type the first sequence number from which analysis is to be started in the Start
Sample No. text box in the Start Conditions screen.
8 Start analysis.
e For information on start of analysis, see
Starting the measurement on page B-68
Roche Diagnostics
Processing reruns
Rerun samples can be processed in two ways: as automatic reruns or as manual

reruns.
Automatic reruns
If a test result is flagged with a data alarm (e.g., the result is outside the technical
limits, >Test alarm) and the automatic rerun function is activated, this test will be
measured again.
Automatic reruns can be performed for most of the data alarms, except for some
alarms according to the rerun list.
e For information on data alarms that can cause an automatic rerun, see:
Rerun list on page D-47.
Automatic reruns can be activated system-wide or application-specific:

o Automatic reruns can be activated for all tests (system-wide setting) in the Start
Conditions screen.
o By means of the application-specific setting you can include or exclude tests from the
automatic rerun (Utility > Application > Range).
The following table shows in which cases an automatic rerun will be performed for a
specific test if the result of this test is flagged with a data alarm:
Automatic rerun setting Rerun

System-wide Application-specific is requested is performed
YES YES l l
YES NO l (a)
–
NO YES l (a)
–
NO NO l(a) –
Table B-15 Correlation between the system-wide and the application-specific rerun setting
(a) The sample status changes back to Ordered (O). An automatic rerun can be performed by restarting the
measurement.
System-wide setting The system-wide setting is displayed in the Automatic Rerun area on the Start
Conditions window.
Roche Diagnostics
a To activate the automatic rerun function (system-wide)

2 Choose Change in the Automatic Rerun area to verify the system-wide rerun
setting.
Figure B-50 Automatic Rerun window
3 Select the Routine check box or STAT check box (or both) to process reruns
without operator intervention. Routine and STAT reruns can be selected
separately.
4 Choose OK to save the rerun setting.
5 Choose Cancel to close the Start Conditions screen.
Application-specific setting Automatic reruns are performed depending on whether the Automatic Rerun check
box on Utility > Application > Range is selected or not for each test. If it is, the test is
automatically requested for rerun and remeasured whenever a result is flagged with a
specific data alarm. This applies to data alarms which indicate that a result is outside
the technical or repeat limit (>Test, <Test, >Rept, <Rept data alarms). Selection of the
Automatic Rerun check box is an application-specific setting; that is, it has to be set
for each individual application.
e For information on using the application-specific rerun setting, see:
Automatic Rerun on page B-229
Repeat limit on page B-230.
Manual reruns
If Automatic Rerun is set to NO in the Start Conditions window, all reruns are to be
processed manually (regardless of application-specific settings). This is an advantage
when you aim for an optimized throughput.
e For information about performing manual reruns, see:
Performing manual reruns on page B-98.
Roche Diagnostics
Reruns with changed sample volumes

Tests that need to be rerun can be measured with normal, decreased, or increased
sample volumes or with diluted samples.
Photometric unit ISE unit

Decreased sample volume l l(a)
Increased sample volume l –
Diluted sample l –
Table B-16 Availability of dilutions for reruns
(a) only for urine samples, only manual rerun
These dilutions, performed by the system, can either be programmed to be

performed automatically or they can be requested manually by the operator or they
can be requested by the Host.
e Refer to the method sheet of the respective application for recommended dilutions.
o Not all displayed dilution ratios are available for every test.
o If you choose a dilution ratio in the S. Vol./D.Ratio field, this selection will overwrite
the pre-programmed dilution ratio indicated in the Utility > Application > Analyze
screen.
If for example the test has a pre-programmed dilution ratio of 1:5 and you select a
dilution ratio of 1:2 for S. Vol./D.Ratio, the test is processed with a dilution of 1:2.
o If the sample volume of a test is higher than 20 L, a manual dilution request is not
accepted and a pop-up window is displayed.
Make sure that sufficient diluent is loaded for the system to dilute samples.
Automatic dilutions Individual tests can be configured with a dilution for the first run and/or rerun.
Dilutions defined in the system are automatically performed and calculated by the
system. Administrator access is required to define these dilution parameters
(Utility > Application > Analyze).
Sample Volume area on page B-223
Manually requested dilutions Dilutions can be requested by the operator. Choose the Sample Volume / Dilution
box on Workplace > Test Selection and select Decrease, Increase, or a dilution ratio
(1:3 - 1:50).
e For more information, see Requesting a test manually on page B-91.
Request from Host Dilutions can also be requested by a Host computer. In this case, the samples are in
the sample disk and processed again.
Roche Diagnostics
Prediluted samples
Manually prediluted samples are samples which have been prediluted before they
were put on the analyzer. (These are not to be confused with manually requested
dilutions.)
Samples which have been manually prediluted can be measured, but the corresponding
dilution factors are NOT taken into consideration when the results are calculated by the
system. It is the operator's responsibility to calculate the final results.
In case you predilute a sample before you reload it onto the analyzer, make sure to
select the Pre-dilution check box on Workplace > Test Selection. The results will
then be flagged with a P (either on the printout or when sending the result to the
host). This indicates that the sample was prediluted and the customer must calculate
the final result.
Performing manual reruns
Samples can be manually selected for rerun if a single test result is flagged with a data
alarm. Even if a result is not flagged with a data alarm, it may sometimes be desirable
to verify a result by a rerun.
This manual procedure is necessary if the Automatic Rerun setting in the Start
Conditions screen is disabled.
e For general information about reruns, see:
Automatic reruns on page B-95.
Roche Diagnostics
Manual reruns in barcode mode

The analyzer software provides several ways to perform a manual rerun in barcode
mode, as shown in the following table.
Case Automatic Instrument Description

rerun(a) status
1 NO Sampling Pause Request a manual rerun using the Rerun
or S.Stop Assignment window, see To request a manual rerun
using the Rerun Assignment window on page B-100.
2 NO Standby Request a manual rerun like a normal test request
(using the Test Selection screen), see Requesting a
test in barcode mode on page B-91.
Advantages: The positions of barcoded samples can
be changed for rerun. New samples can be measured
at the same time if already completed samples are
removed from the sample disk. You can change the
sample volume or request a dilution for rerun.
3 YES If 3rd Results Acceptance is enabled (Utility >
System screen), a manual rerun can be performed to
receive a third result.
The first and second (auto rerun) result must have
been transmitted to host before. Use one of the
methods described in case 1 or 2 to request a manual
rerun.
Table B-17 Possibilities of manual rerun in barcode mode
(a) Setting on the Start Conditions screen.
e For information about 3rd Results Acceptance, see:

Generating multiple results for a single test on page B-240.
Manual reruns in non-barcode mode

The analyzer software provides two ways to perform a manual rerun in non-barcode
mode, as shown in the following table.
Case Automatic Instrument Description

rerun(a) status
1 NO Sampling Pause Request a manual rerun using the Rerun
or S.Stop Assignment window, see To request a manual rerun
using the Rerun Assignment window on page B-100.
2 NO Standby Request a manual rerun like a normal test request
(using the Test Selection screen), see Requesting a
test in non-barcode mode on page B-93.
In the Test Selection screen, note the first sequence
number from which the rerun is to be started. This
number must be entered into the Start Conditions
screen.
Advantage: You can change the sample volume or
request a dilution for rerun.
Table B-18 Possibilities of manual rerun in non-barcode mode
(a) Setting on the Start Conditions screen.
Roche Diagnostics
Requesting manual reruns (barcode or non-barcode mode)
a To request a manual rerun using the Rerun Assignment window

1 Make sure that the analyzer is in Sampling Pause or S.Stop status. Choose Pause
(global button) if the analyzer is in Operation status.
3 Select one sample that requires a manual rerun.
5 Choose the Rerun Assignment button to request a manual rerun for this sample.
Figure B-51 Rerun Assignment window (barcode mode)
6 Choose Add in the Rerun Assignment window to add this sample to the Manual
Rerun list in the bottom of this window.
7 Choose OK to close the Rerun Assignment window.
8 On the Test Selection screen, select the tests that require a manual rerun.
The color of a selected test key changes from yellow to white (manual rerun) or
from gray to white (3rd result). Tests may also be added which have not been
measured before.
9 Choose Save on the Test Selection screen.
10 Repeat the previous procedure up to the last sample that requires a rerun.
12 Choose Start to initiate the rerun.
When pipetting of a rerun sample begins, this sample will be deleted from the
Manual Rerun List.
If a sample listed in the Manual Rerun List is not placed on the sample disk, this
request will be deleted.
Roche Diagnostics
Extended sample processing
This section describes optional routines that may be used during a run:
o Additional tests
o Additional samples
Processing additional tests

During a run, additional tests for samples on the sample disk can be requested
manually or via the host.
The workflow differs depending on whether SBS mode is used or not:
o When operating without SBS mode, additional tests can be requested during
Standby, Sampling Stop, or Sampling Pause. They will be processed in the next
run.
Note that additional requests should not be sent from the host during a run.
o When operating in SBS mode, additional tests are processed automatically.
Additional tests can be requested during normal operation if the sample is already
completed, or during Sampling Pause.
e For an explanation of SBS mode, see:
Open test requests (with SBS mode) on page B-113.
a To order additional tests in SBS mode

1 Choose Workplace > Data Review and select a sample that has already been
measured.
3 Select the desired additional tests and choose Save.
The status of the sample changes to Ordered ("O") on the Data Review screen.
The SBS internal database check is performed.
The analyzer processes all open test requests identified in the SBS database check.
If the 6th and final SBS database check has already been performed before additional
tests are ordered, restart the measurement to perform the tests during the next run.
e See: Additional samples or tests on page B-113.
Processing additional samples

There are two priority levels for additional samples: STAT (emergency) and routine,
where the first takes priority over the second. In either case, test selections for
additional samples are downloaded from the Host in realtime.
e For more information on priority levels, see:
General pipetting priority on page B-121
o STAT samples can be requested during normal operation. They are measured
through interruption of the routine samples using the following procedure.
o Routine samples can be requested using the following procedure.
Roche Diagnostics
a To process additional samples during operation

1 Choose Pause/Scan (global button).
2 Choose Pause on the Sample Pause/Scan window.
In non-barcode mode, a window appears warning you not to exchange any
samples.
o If you choose Pause/S.Stop, you can add additional samples once pipetting
stops and the green Sample Disk Access Lamp comes on. The status line
shows Sampling Pause.
o If you do not want to add any samples, choose Continue and then Close.

o When operating in non-barcode mode, make sure to load the samples to their
CAUTION registered positions.
o Do not move or exchange any samples that are already on the disk.
3 Wait until the Access Sample Disk lamp comes on.
o If a routine sample is currently being pipetted, it takes about 3-4 pipetting cycles
before the instrument enters Sampling Pause status.
o If a STAT sample is currently being pipetted, pipetting of all tests of the STAT
sample will be completed before entering Sampling Pause status.
o Pipetting of calibrator or QC samples cannot be paused. Press the Pause button
again when pipetting of all requested calibrators and QCs is completed.
4 Load the additional samples onto the disk.

5 Choose Start (global button) to open the Start Conditions screen.
6 Choose Start on the Start Conditions screen to initiate the run.
In non-barcode mode, a window opens asking you to confirm that no samples
have been exchanged. If you choose Not Exchanged, the instrument goes back to
Operation.
The sample disk rotates and checks to see which positions on the sample disk are
occupied. In barcode mode, each sample ID will be read.
If non-barcoded samples have been exchanged, all test requests must be deleted.
Choose Exchanged and the Start Conditions screen appears again. Now, choose
S.Stop (global button) to put the analyzer into Standby and delete the test requests.
After deletion, all test selections must be re-entered or re-downloaded from the host.
Roche Diagnostics
Entering unreadable sample barcodes
The barcode label must be attached in such a way that it is visible through the
openings in the sample disk.
A Sample tube (100 mm) B Openings for barcode scanning
Figure B-52 Samples on the outer ring with their barcode facing outwards
For a sample without a barcode, or an unreadable barcode an extra registration step is

necessary. The sample with the barcode read error is marked with in the Sample
Tracking window.
Roche Diagnostics
a To enter an unreadable sample barcode

2 Choose Barcode Read Error.
Figure B-53 Barcode Read Error window
3 Select Stat or Routine in the Sample area and press <Enter>.

4 Select the sample material from the Type list box and press <Enter>.
Incorrect results due to position mismatch

Check the manually entered ID against the sample ID on the sample container.
Make sure that the samples are loaded in the correct position on the sample disk.
5 Type the position in the Disk Pos. text box and press <Enter>.
6 Type the sample ID of the sample in the Sample ID text box and press <Enter>.
7 Choose Add. The sample type, position, and sample ID are displayed.
8 Repeat steps 3 to 7 for any further samples with a barcode read error.
9 Choose OK.
Disk position assignment is deleted after the sample has been measured
If you want to manually rerun a sample with unreadable barcode, you have to reassign the
position of this sample in the Barcode Read Error window. Then this sample can be put
in the Manual Rerun list in the Rerun Assignment window.
e See: Requesting manual reruns (barcode or non-barcode mode) on page B-100
Roche Diagnostics
Data Review screen
Data Review screen
To display this screen, choose Workplace > Data Review.
Figure B-54 Data Review screen (barcode mode)
Use this screen to perform tasks related to reviewing and editing routine and STAT
results. Control results can also be viewed here.
Other tasks that can be performed from this screen include editing demographic
information, sending data to the Host, editing, and deleting data individually or in
batches, backing up data.
Status column The St. column displays the sample status codes.

I (Incomplete) Sample is processed, but a data alarm is present.
No symbol (Complete) Sample is successfully processed (no alarm present).
H (Sent to Host) Sample results has been sent to the Host.
Roche Diagnostics
Data Review screen
Disk column This column displays the disk position number (001-108) of the current sample. It
also shows how the sample was run, using the following code:
Code Sample
N Routine (normal sample)
E STAT (emergency sample)
C QC (control sample)
Table B-19 Disk position codes in the Data Review screen
e For more information about the different sample information fields and the buttons on
this screen, refer to the Online Help of the particular field or button.
Displaying archived patient data on page B-110
Archiving patient data
Use this function to make backup copies of test results on a DVD (when operating
without a Host or for a backup additionally to the Host).
a To archive patient data

2 Select the samples for which data is to be backed up from the list on the left of the
Data Review screen.
3 Choose Backup Data to display the Backup Data window.
Figure B-55 Backup Data window
4 Select the medium to which the data will be written, for example Floppy Disk,
from the Media area.
o If only one medium is available, for example, floppy disk, the Media area is not
active.
o Mass Storage denotes the DVD disk.
5 Insert the chosen medium into the corresponding disk drive.

6 Type the name to be given to the file in the File Name text box.
Roche Diagnostics
Data Review screen
7 Select the format in which the data is to be written, ASCII or Binary, and select
the Base Data or All Data option in the File Format area.
o ASCII files can be read by other PC systems, but cannot be reloaded into the
o Binary files can be reloaded into the cobas c 311 analyzer (Workplace > Data
Review > choose Backup Media from the data list box), but cannot be read by
other PC systems.
o Base Data will only save the measurement results and the data alarms.
o All Data will additionally save the units of the measurement results and the sample
volume/dilution ratio.
8 Choose OK to back up the selected data after confirmation. The Save Data
window is displayed. This closes after the data has been backed up.
If a confirmation window with the message Mass storage media is full or Floppy disk is
full is displayed during backup, no data is stored on the media.
o Insert an empty medium and repeat the backup process
e For applicable DVD media types, see: Control unit on page A-73.
Editing or deleting sample data
Sample data displayed on the Data Review screen can be edited or deleted if required.
Use the following procedures to edit or delete sample data.
a To select a result to be edited or deleted

2 Select the data source, Routine View or Backup Media, from the list box in the
Data area from which the sample data is to be reviewed.
QC View is also available as an option in the list box in the Data area, but this view
displays only QC data.
e For information on using a Backup Disk, see Displaying archived patient data on
page B-110.
3 Select a sample from the list on the left of the screen. The results, 1st and Rerun, of
the tests performed on this sample are displayed in the list on the right of the
screen.
Roche Diagnostics
Data Review screen
4 Choose Test Review to display the Test Review window. This window displays
more information on the test results.
Figure B-56 Test Review window
5 Select the test result in the Data column. The result is activated (blue background)
and highlighted white.

No symbol (Complete) Sample successfully processed. All test results are available
without a data flag.
H (Sent to Host) Sample results have been sent to the Host.
M (Mask Test) Test has been masked due to an abnormality during processing.
No alarm will be displayed or shown on the printout.
o Reagent or diluent for a requested test is not on board or
empty
o Auto masking due to failed calibration
o Test is manually masked (Start Condition > Masking)
E (Edited Test) Sample results have been manually edited on Workplace > Data
Review > Test Review.
I (Incomplete) Sample is processed, but a data alarm is present.
Roche Diagnostics
Data Review screen
a To edit sample data
Edited test results will always be flagged.
1 Select the test result to be edited.

2 Enter the new result (the old result is overwritten) and press <Enter>. The Update
button turns yellow.
3 Choose Update to save the changes or Cancel to reset the entry to the original
value.
a To delete sample data

1 Select the test result to be deleted.
2 Choose Delete Test to delete the test after confirmation.
a To delete a sample
2 Select an individual sample, or a number of samples, to delete from the list on the
left of the screen.
3 Choose Delete Record to delete the sample(s) selected after confirmation.
When a QC sample is deleted from Routine View, this will be transferred to the QC View
Database. To delete this you have to delete the QC sample from the QC View Database.
The Sample Count is unchanged after a record has been deleted. To delete all records,
use Delete All. This will reset the sample count to 0.
Roche Diagnostics
Data Review screen
Displaying archived patient data
Only data saved in binary format can be reloaded onto the control unit.
e See Archiving patient data on page B-106
Reloaded data can only be viewed on the Data Review screen.
Mismatching versions of analyzer system software

Patient data written by a newer version cannot be read onto an analyzer with an older
version of system software.
a To display archived patient data

1 Select Backup Media from the Data list box on the Workplace > Data Review
screen to display the Read Backup Disk window.
Figure B-57 Read Backup disk window
2 Insert the DVD into the DVD drive.

3 Type the file name in which the data is saved in the File Name text box.
4 Choose OK. The saved data is displayed on Workplace > Data Review.
Roche Diagnostics
Data Review screen
Tracking samples on the analyzer
o Only STAT and routine samples can be searched for in the Sample Tracking window.
o The location of a sample is only indicated on the Sample Tracking window once a
sample has been scanned.
a To track a sample on the analyzer

1 Choose the graphical icon representing the analyzer in the status line (top left of
the screen) to display the System Overview screen.
2 Choose Sample Tracking to display the Sample Tracking window.
Figure B-58 Sample Tracking window
3 Choose Sample Search to display the Sample Search window.
Figure B-59 Sample Search window (non-barcode mode)
Roche Diagnostics
Open test requests
4 Choose the Stat or Routine tab, depending on what kind of sample you are
searching for.
5 Select one of the following search options (e.g., to search by sample type):
o Sample Type
o Sample ID (barcode mode only)
o Sequence No. (non-barcode mode only)
o Disk position (non-barcode mode and STAT only)
o Main comment
6 Choose OK.
The samples that match the search criteria will be marked in the graphics
representing the sample disk.
e For information about the Position Status area, see:

Position status on page B-72.
Open test requests
After a run has been completed, you may find that some of the tests you requested
could not be performed. These open test requests (or open orders) may occur, for
example, if you request additional tests for a sample, or if a data alarm occurs while
automatic rerun is inactive.
With SBS mode The SBS mode function allows the analyzer to process open test requests
automatically without operator intervention in most cases. In some exceptional cases,
e See Open test requests (with SBS mode) on page B-113.
Without SBS mode If the SBS function is not activated, open test requests will require operator
intervention. You must check each open test request and eliminate the cause before
the open test request can be processed. Therefore we strongly recommend using the
SBS mode.
e See Open test requests (without SBS mode) on page B-114.
Roche Diagnostics
Open test requests
Open test requests (with SBS mode)
If SBS mode is activated, the analyzer scans the sample database after a run to check
for open test requests (SBS = scan before sample stop). The analyzer processes the
following categories of open test requests without operator intervention:
o Test orders without results (exceptions see below)
o Additional test orders for first run or rerun
o Tests which you have previously unmasked during operation (P-Mask, T-Mask,
Calib. Mask)
Exceptions The following open test requests require user intervention:

o Rerun orders caused by data alarms, which do not invoke an automatic rerun
(Cal.E, ClcT.E, >Index, Mix.E, Reag.S, Samp.C, Samp.S)
o Rerun orders for tests where the test-specific automatic rerun is switched OFF
o Samples not measured yet (marked blue on Sample Tracking screen)
Configuration of SBS mode

The SBS mode must be activated on the Barcode Setting window (Utility >System).
The automatic rerun and host communication settings are also relevant for the
correct functioning.
e See: To activate SBS mode on page B-239
SBS basic functionality

At the end of the run, when all first run and rerun results are available, the analyzer
checks the internal sample database to collect open test requests (test orders without
results and orders for additional tests). This SBS database check is running in the
background and takes no more than 10 seconds.
A new arrival time is displayed in the Data Review screen for samples with open test
requests that are performed by SBS mode.
Pause/Scan and S.Stop buttons Both buttons can be used during SBS mode, as in normal operation.
Additional samples or tests You may add additional samples when the Pause/Scan button is pressed (Sampling
Pause). The additional samples are measured after restarting from Pause.
Additional tests can be requested during normal operation if the sample is already
completed, or during Sampling Pause.
The SBS database can be checked several times during a run (up to six times). So even
if the first database check has already been performed, additional tests or samples will
be measured in the next cycle. (After the sixth database check during a run, the
analyzer goes into Sample Reception mode or Standby. If you have added samples,
calibrators or controls several times during a run, there may still be some open orders
remaining after six database checks. In this case you only need to initiate a restart.)
To order additional tests in SBS mode on page B-101
To process additional samples during operation on page B-102.
Roche Diagnostics
Open test requests
Pipetting priority If samples are added during Sampling Pause in SBS mode, they are processed with a
lower priority than samples already identified during the SBS database check.
e For more information on priority levels, see:
General pipetting priority on page B-121
Workflows when using SBS mode

As described before, open test requests may occur in some exceptional cases even
though SBS mode is activated.
Therefore, it is important to check for open requests after each run. Check for the
cause and process the exceptions manually.
e For the procedures required in these cases, see:
To check for open test requests on page B-73
To process open test requests that could not be processed automatically on page B-75
To process samples not measured yet on page B-75.
Open test requests (without SBS mode)
After a run has been completed, you may find that some requested tests could not be
performed. These leftover tests or open test requests (or open orders) fall into the
following categories:
o Open test requests with a Confirmation window
o Additional test requests:
a) Requested by user (with a Confirmation window)
b) Requested by host (cannot be detected by the analyzer software)
Do not remove affected samples from the disk

Do not remove samples for which there are open or additional test requests from the
sample disk.
Open test requests with a Although a test request exists, it is not carried out. This may occur under certain
Confirmation window circumstances (see Table B-20 on page 117). This category of open test requests is
identified by the following Confirmation window.
Roche Diagnostics
Open test requests
Additional test requests The cobas c 311 analyzer only scans the sample disk at the beginning of a run.
Therefore, the analyzer cannot automatically process any additional tests requested
during the run (by user or host).
Additional test request is used as a generic term for the following cases:
o Manual reruns
o 3rd results
o Additional test selections
Two subcategories of additional test requests must be distinguished:
a) In case the user requested additional tests via the analyzer software, the same
confirmation window (Figure B-60) appears after the run.
b) Additional tests requested by the host are not indicated in the analyzer
software. Information about additional tests to be measured must be sent
manually from host to the analyzer.
Roche Diagnostics
Open test requests
How to proceed with open test requests

The following flow chart shows you how to proceed if a requested test was not
performed during a run.
Additional tests
Open test requests
with a Confirmation window requested requested
by user by host
1. Be aware of issue Additional tests

requested during the run
(2) Page B-118
Identify and eliminate Identify and eliminate the

2.
cause cause
(1) Page B-117
Working in barcode or
3. Yes No
non-barcode mode? Barcode mode?
4. Check analyzer status

Status?
Sampling Stop (Sample Reception) Standby

Sampling Pause
or:
Perform appropriate Check sample and change Change sequence number on

5.
measures position Start Conditions screen
(3) (4) (5)

Page B-119 Page B-119 Page B-120
Restart Perform a manual Restart

measurement rerun measurement
Page B-98
Figure B-61 Workflow for open test requests
Roche Diagnostics
Open test requests
Identifying the cause of open test requests (1)

Perform the following steps to identify and eliminate the cause of open test requests.
a To identify and eliminate the cause of open test requests

1 After the run, choose OK to confirm the Confirmation window.
2 On the Workplace > Data Review screen, check for samples with status Ordered
("O") in the status (St.) column.
If there are Ordered samples without results, this indicates open test requests.
Alternatively, choose System Overview > Sample Tracking and check for
samples with Position Status Failed, Sample Error, or Barcode Error.
3 In non-barcode mode, note the sequence number (S. No.) of the affected samples.
Do not change the disk position of these samples.
4 Identify and eliminate the cause of the open test request using Table B-20:
Checks Cause of open test requests Remedies

A m Check Data Review screen for any data Sample Short (Samp.S) or Sample Clot See chapter Data alarms in the
alarms. (Samp.C) occurred; or another data alarm Operator’s Manual.
occurred (e.g., <Test) and auto-rerun is
inactive.
B m Check Start Conditions > Masking. The test could not be performed because Unmask the test.
test or patient masking is active.
C m For all applications: Check Utility > System The calibration of this test has failed and Perform a new calibration or
(Page 2/5) > Calib Mask setting. automatic calibration masking is active. reject the failed calibration.
m For each test: Check Utility > Application >
Calib.
D m Check Sample Tracking window for Cup An incorrect sample ID or Application o Correct the sample ID or
Present indicated in blue. Code No. (ACN) was sent via host; or no ACN.
m Check for yellow alarms: Host receiving Text tests were requested for a sample. o Enter test selection or send
error, or Host communication Error. it via batch manually from
m Check Data Review screen if tests are listed. host.
Table B-20 Causes of open test requests with a Confirmation window
5 After performing the remedy, follow the procedures described in Processing open
test requests (without SBS mode) on page 119.
Roche Diagnostics
Open test requests
Identifying additional test requests (2)

Additional tests may have been requested during the run (by user or host). In this
case, they cannot be processed automatically.
Therefore, always check for additional test requests before you remove samples from
the disk.
a To check for additional test requests

1 After the run, choose OK to confirm the Confirmation window (if present).
3 Check for samples with status Ordered ("O") in the status (St.) column for which
results are NOT available.
If results are NOT available for Ordered samples, this indicates additional tests
have been requested (by the user).
Additional tests requested by the host are not indicated in the analyzer software.
Information about additional tests to be measured must be provided by the host.
4 Follow the procedures described under Processing open test requests (without SBS
mode) on page 119.
Roche Diagnostics
Open test requests
Processing open test requests (without SBS mode)
The procedure for restarting the measurement depends on whether the analyzer is in
barcode or non-barcode mode.
Restarting measurement (barcode mode) (3)

Open test requests can be processed either from Standby, Sampling Stop, or Sampling
Pause status.
a To restart measurement
2 Remove the affected sample from the sample disk and check the sample container
visually for sample clot or sample short.
3 Place the sample into a new position on the disk.
All samples with test requests are processed. No further action is required.
Notes
o If the analyzer is in Standby, open or additional requests are performed
automatically when you restart measurement. The position of the affected samples
may be changed (or you can leave them in their original position). All samples with
test requests will be processed, not only those samples that were not measured
during the previous run.
status, the position of the affected samples must be changed before you press
Start. Repositioned samples will be measured after all other samples are processed.
Manual rerun (4)
Barcode mode For barcoded samples, you have the following options:
o Move the sample to another position.
e See To restart measurement on page B-119.
o Perform a manual rerun.
e See Requesting manual reruns (barcode or non-barcode mode) in the Operator’s
Manual.
Non-barcode mode Open test requests can be processed either from Standby, Sampling Stop, or Sampling
Pause status.
status, perform a manual rerun using the Rerun Assignment window.
e See Requesting manual reruns (barcode or non-barcode mode) in the Operator’s
Manual.
o If the analyzer is in Standby, the sequence number must be changed before you
press Start.
e See Restart measurement from Standby (non-barcode mode) (5) on page 120.
Roche Diagnostics
Open test requests
Restart measurement from Standby (non-barcode mode) (5)

In non-barcode mode, make sure that any removed samples are reloaded to their originally
CAUTION registered positions. The registered tests and sample positions can be checked on the
Workplace > Data Review screen.
a To restart measurement
2 On the Data Review screen, note the lowest sequence number (S. No.) of the
affected samples.
3 Change the test selection if required. Make sure to save the test selection.
5 In the Start Sample No. text box, enter the lowest sequence number.
Figure B-62 Start Conditions screen
6 Choose Start to restart the measurement.

All samples beginning from the entered sequence number with open test requests
will be processed.
Roche Diagnostics
General pipetting priority
General pipetting priority
This overview shows in which priority samples are processed, regardless of whether
SBS mode is activated or not.
Basic pipetting priority: During normal operation as well as in SBS mode, samples are pipetted with the
following priority:
1. STAT sample(a) with rerun orders
2. STAT sample with 1st run orders
3. Routine sample with rerun orders
4. Routine sample with 1st run orders
Calibration and QC requests: Calibration and QC can be requested during Sampling Pause. This affects the
pipetting priority.
1. Calibration
2. QC after calibration
3. STAT sample with rerun orders
5. Routine QC / auto QC
Additional samples If samples are added during Sampling Pause in SBS mode, they are processed with a
lower priority than samples already identified during the SBS database check.
1. STAT sample with rerun orders
3. STAT sample added (during Sampling Pause)
6. Routine sample added (during Sampling Pause)
(a) Regarding to SBS mode, STAT sample here always means a STAT sample already identified during the
last SBS database check.
Roche Diagnostics
Preparing a DVD disk
The cobas c 311 control unit computer is optionally equipped with a optical disk
drive. The optical disk drive can be used for installing software updates and backing
up and restoring data.
Supported disk types The following disk types can be used for backing up data.
Disk type Recordable / Rewritable

DVD-R Recordable
DVD+R Recordable
DVD-RW Rewritable
DVD+RW Rewritable
Table B-21 Disk types: Supported types
Unsupported disk types All disks that are not listed in Supported disk types cannot be used for backing up
data, e.g. the following disk types:
o CD-R
o CD-RW
o DVD-R DL
o DVD+R DL
o DVD-RW DL
o DVD+RW DL
o DVD-RAM
o All types of Blu-ray disks
Formatting is required All disks must be formatted (initialized) on the cobas c 311 control unit computer,
before they can be used for backing up data on them.
e See Formatting a disk on page B-123
Compatibility to other Most disks must be made compatible so they can be read by other computers than the
computers cobas c 311 control unit computer.
e See Making a disk compatible on page B-125
The following disks must be made compatible:

o DVD-R
o DVD+R
o DVD-RW
The disks are formatted with UDF (Universal Disk Format). The disks can only be
read on computers that support UDF.
Roche Diagnostics
Recordable and rewritable disks Recordable disks (DVD-R, DVD+R):

o Each burn is permanent. It is not possible to delete data.
o It is not possible to reformat and rewrite a recordable disk.
o It is not possible to add data after the disk has made compatible.
o If you perform backups repeatedly without removing the disk from the
cobas c 311 control unit, recordable disk can be used.
Rewritable disks (DVD-RW, DVD+RW):
o It is possible to delete data.
o It is possible to reformat the disk.
o It is possible to add data after the disk has made compatible.
o It is possible to make the disk compatible for several times.
o If you want to use a disk in other computers and then add more backups at the
cobas c 311 control unit, rewritable disks are required.
Formatting a disk
All disks must be formatted (initialized) on the cobas c 311 control unit computer,
before you can backing up data on it.
Danger of data loss

Formatting a disk deletes all data on the disk.
CAUTION o Before formatting a disk, make sure that no important data is stored on the disk.
Formatting several times Recordable disks can be formatted once only. Rewritable disks can be formatted
several times. The formatting function can be used to delete all data from rewritable
disk.
e For Information about the disk types, see Supported disk types on page B-122
Formatting on other computers Only format disks on the cobas c 311 control unit computer. The cobas c 311 control
unit computer may not be able to read disks formatted on any other computer.
Roche Diagnostics
Different types of formatting The cobas c 311 control unit computer can perform either a Quick (erase) or Full
format of the discs. The following table describes the fundamental differences
between the two.
Quick (erase) format Full format

Faster (generally taking less than 60 seconds). Depending on the speed of the drive and the
size of the disk, this can take up to 20 minutes
or more.
Can be performed on all recordable disks and Only available for rewritable disks.
on previously formatted rewritable disks.
Must be initially performed for all recordable Must be initially performed for all rewritable
disks. disks
Will not repair disc errors. Repairs some errors by preventing data from
being written on damaged sections of the
disk.
Table B-22 Formatting: Comparison of the different types
a To format a disk
o The procedure for formatting a disk may differ, depending on the configuration of your
system.
o Once the formatting operation is started, it cannot be cancelled.
o Formatting a disk deletes all data on the disk.
1 Make sure the analyzer is in standby.

2 Insert a new disk into the disk drive.
e For information about supported disk types, see Supported disk types on page B-122
3 Press <Ctrl>+<F7> to display the Format window.
Figure B-63 DLA format window
4 Type a name for the disk in the Volume label text box if desired.
5 Choose Quick (erase) or Full from the Format type area.
Depending on the type of disk only one option is available.
e For more information about format types, see Different types of formatting on
page B-124
6 Choose Start and confirm the formatting process with Yes.

The disk is formatted. This may take several minutes.
7 After formatting is finished confirm with OK.
The disk is ready for a data backup now.
Roche Diagnostics
Making a disk compatible
Most disks must be made compatible so they can be read by other computers than the
cobas c 311 control unit computer.
Availability for disk types The make compatible function is not for all disk types available. The following table
describes the availability for the disk types.
Disk type Make compatible available? Can more data be added after using
make compatible?
DVD-R Yes No
DVD+R Yes No
DVD-RW Yes Yes
DVD+RW No n/a
Table B-23 Make compatible: Availability for disk types
Adding data after making After a disk has been made compatible usually it is not possible to add data on it.
compatible However, for some disk types it is possible to add data after the disk has been made
compatible. After adding data the disk must be made compatible again so it can be
read by another computer than the cobas c 311 core unit computer.
e For information about the disk types, see Availability for disk types on page B-125
a To make a DVD disk compatible
o The procedure for making a disk compatible may differ, depending on the
configuration of your system.
o Once the making compatible operation is started, it cannot be cancelled.
1 Make sure the analyzer is in standby.

2 Insert the disk into the disk drive.
3 Press <Ctrl>+<F8> to display the Compatibility window.
Figure B-64 Compatibility window
4 Choose Start and confirm the process with Yes.

The disk is made compatible. This may take several minutes.
5 After making compatible is finished confirm with OK.
The disk is ready to be used on other computers.
Roche Diagnostics
Roche Diagnostics
cobas c 311 analyzer 8 Reagents
Table of contents
Reagents
This chapter describes all types of reagents used on the cobas c 311 analyzer. It
provides information about the system’s reagent management as well as detailed
information on how the operator can monitor the status of loaded reagents
(operator-related reagent management).

Reagent concept .......................................................................................................... B-129
Reagents for ISE applications .............................................................................. B-129
Reagents for photometric applications .............................................................. B-131
Diluents ............................................................................................................ B-131
Auxiliary reagents and detergents ................................................................ B-132
Calibrators and controls ................................................................................ B-133
cobas c packs ................................................................................................................ B-133
Barcode label .......................................................................................................... B-134
Handling of reagents .................................................................................................. B-135
ISE reagent registration ........................................................................................ B-135
Notes on replacement of ISE reagents ............................................................... B-135
Reagent registration .............................................................................................. B-136
Remaining volume control .................................................................................. B-136
Unloading and reloading cobas c packs ............................................................ B-137
Carryover evasion ................................................................................................. B-137
Reagent screen overview ............................................................................................ B-138
Reagent Setting screen ................................................................................................ B-139
Reagent Status screen ................................................................................................. B-140
Replacing auxiliary reagents ................................................................................ B-140
Reagent Overview button ........................................................................................... B-143
Reagent Overview window .................................................................................. B-144
Roche Diagnostics
8 Reagents cobas c 311 analyzer
Table of contents
Roche Diagnostics
Reagent concept
Reagent concept
Reagents This section provides information about reagents used on the cobas c 311 analyzer,
how they are used for ISE applications and photometric applications. It describes the
reagent containers and explains how the analyzer registers new reagents and how it
monitors reagent consumption.
Reagents for ISE applications
This section describes all reagents necessary to run the cobas c 311 analyzer’s ISE unit
and the reagents that are specific for each available ISE application. The following ISE
applications are available:
ISE applications ISE applications

Potassium serum/plasma Potassium urine
Sodium serum/plasma Sodium urine
Chloride serum/plasma Chloride urine
Table B-24 List of ISE applications
Reference information for ISE The following table compiles reference information for all ISE reagents, such as
reagents auxiliary reagents, calibrators, and controls.
Product name Short name(a) Containers on the Localization or

analyzer code
Reagents for measurements ISE Internal Standard Gen.2 ISE IS 1 bottle of 600 mL ISE reagent
ISE Diluent Gen.2 ISE Dil. 1 bottle of 300 mL compartments
ISE Reference Electrolyte ISE Ref. 1 bottle of 300 mL

Calibrators(b) ISE Standard low ISE Low Cup or cup on 502
ISE Standard high ISE High tube(c) 503
ISE Compensator (global use) ISE Comp. 504
ISE Standard high ISE High (compensated) 763
(compensated) (use in US only) (use in US only)
Quality controls Precinorm U/Precinorm U Plus PNU/PNU Plus Cup or cup on 300
Precipath U/Precipath U Plus PPU/PPU Plus tube(c) 301
(d)
Auxiliary reagents for maintenance ISE cleaning solution SysClean Cup or cup on Position W1
ISE Activator Activator tube(c) or tube Position W2
Table B-25 ISE reagents
(a) used in this documentation
(b) The calibration interval is 24 hours for all ISE applications. Calibrators are also named standards.
(c) Hitachi cup or cup on standard tube in the sample disk, see Sample cups and tubes on page A-77.
(d) For washing of ISE electrodes (maintenance item (10) ISE Wash).
Roche Diagnostics
Reagent concept
Reagents for measurements Each ISE measurement uses the following reagents:
o Internal standard (ISE IS), used for one-point calibrations performed before and
after each sample determination
o Reference solution (ISE Ref.), used for reference electrode measurements
o Diluent (ISE Dil.), used for 1:31 dilution of sample
ISE auxiliary reagents (ISE IS, ISE Ref., ISE Dil.) are supplied in reagent bottles and
do not use a barcode for registration. ISE auxiliary reagents are to be replaced only
when the instrument is in Maintenance mode or in Shutdown status.
After the replacement of an ISE reagent, the following steps are required:
1. Reset the initial volume.
2. Perform a Reagent Prime to fill the flow path with the new liquid (not required
after replacement of ISE Dil.).
3. Calibrate the ISE unit.
e For more information about replacement of ISE reagents, see:
ISE reagents on page B-52.
Calibrators The following ISE calibrators are used depending on the calibration method:
o Std (1) or S1: ISE Low, a water-based solution
o Std (2) or S2: ISE High, a water-based solution
o Std (3) or S3:
o For global use: ISE Comp., a serum-based solution, used for blank
calibrations, full calibrations as well as for conditioning the electrodes
o For use in US only: ISE High (compensated) with compensated set points is used
for full calibrations.
The calibration interval for all ISE applications is 24 hours.
Quality controls The following products are used for quality controls:
o PNU or PNU Plus
o PPU or PPU Plus
Quality controls can be used either with barcode or without. The operator can decide
whether to use barcodes, change the settings in the software if necessary (Barcode
Setting area on Utility > System), but then has to stick to the respective mode for QC
measurements.
Do not put barcoded sample tubes to assigned positions for calibrators or quality controls.
Be consistent with the software settings (Position Assignment under Calibration >
Calibrator and under QC > Control).
e For more information on ISE reagents, see:

ISE reagent registration on page B-135
ISE reagents on page B-52.
Roche Diagnostics
Reagent concept
Reagents for photometric applications
This section describes all reagents necessary to run the photometric unit. It provides
an overview of diluents, auxiliary reagents (such as basic and acidic detergents), as
well as calibrators and controls.
Diluents
Short name Long name Comment

NaCl NaCl 9% Diluent for photometric tests
A1CD2 Hemolyzing Reagent Gen.2 Diluent for HbA1c whole blood test
Table B-26 Diluents for photometric tests
NaCl For photometric applications, either water or a NaCl solution is used as diluent. The
water is deionized water from the analyzer’s water tank. NaCl solution is supplied in
cobas c packs NaCl 9%.
Whenever used as diluent, the 9% solution from the cobas c pack is diluted with
water to a concentration of 0.9% by the analyzer.
Make sure you have sufficient diluent on the analyzer—especially if a higher demand of
diluent can be expected.
A1CD2 The diluent for HbA1c whole blood tests is also supplied in a cobas c pack.
e For information about the HbA1c whole blood application, see:
Loading the HbA1c Whole blood application on page B-217.
Roche Diagnostics
Reagent concept
Auxiliary reagents and detergents

The analyzer uses the following auxiliary reagents and detergents:
Product name Short Description Containers on the Localization

name(a) analyzer
Cell Wash Solution CellCln I NaOH-D, used for rinsing and cleaning of reaction 1 bottle of 1.8 L Behind the
I / NaOH-D cells left front door
Cell Wash Solution CellCln II Acid wash, test specific, used for rinsing and 1 bottle of 2.0 L
II / Acid Wash cleaning of reaction cells
Sample Cleaner 1 SmpCln 1 Sample probe wash solution 1, NaOH 1 mol/L 1 bottle of 70 mL Near sample
Sample Cleaner 2 SmpCln 2 Sample probe wash solution 2, 200 mmol/L HCl 1 bottle of 70 mL probe
Hitergent Hitergent Surfactant for incubator bath to prevent algae 1 cobas c pack of Reagent disk
proliferation and foaming 50 mL
NaOHD NaOH-D Detergent 1 for special washes (carryover evasion, 1 cobas c pack of Reagent disk
reagent probe and cell wash, if necessary) and cell 50 mL
wash (Maintenance item (6) Wash Reaction Parts)
SMS SMS Detergent 2 for special washes (carryover evasion, 1 cobas c pack of
reagent probe and cell wash, if necessary) 50 mL
Table B-27 Photometric auxiliary reagents and detergents
(a) used in this documentation
e To locate these reagents and detergents on the analyzer, see:

Behind the front doors on page A-64
Sampling area components on page A-37
e For information about replacing detergents and reagents, see:
To load a cobas c pack on page B-55
e For information about special washes, see:
Special Wash on page B-255
Remaining volume control for The remaining volumes of the auxiliary reagents are monitored by countdown,
reagent bottles starting from a given initial volume. The remaining volumes are displayed on the
Reagent > Status screen. Whenever a reagent bottle is replaced, the operator has to
reset the initial volume. Reagent registration is not performed automatically
whenever a new bottle is placed on the analyzer.
e For more information on monitoring the reagent status, see:
Replacing auxiliary reagents on page B-140
Roche Diagnostics
cobas c packs
Calibrators and controls

For photometric applications, there are universal calibrators and special calibrators
available. The same universal calibrator is used for a large number of applications
whereas a special calibrator covers only a few or only one application.
Universal calibrators are Cfas or Cfas Proteins.
Likewise, there are universal and special controls (e.g., PNU/PPU and HBCN/HBCP
respectively).
e For information about calibrators and quality control reagents for specific applications,
refer to the respective instructions for use in cobas link.
Most of the calibrators and controls have to be reconstituted and pipetted into cups.
cobas c packs
Apart from a number of reagent bottles for auxiliary reagents, the principal reagent
container is the cobas c pack (COBAS INTEGRA cassettes can also be used).
All information about cobas c packs in this manual also applies to COBAS INTEGRA
cassettes.
In addition to the cobas c packs and COBAS INTEGRA cassette types, there is the
cobas c pack MULTI, which is an empty barcoded cobas c pack. These kits are used
for development channel applications and lyophilized reagents, which have to be
mixed with solvent just prior to use. To prepare a cobas c pack MULTI for use on the
analyzer follow the instructions given in the instructions for use in cobas link.
Figure B-65 cobas c pack with position designations
A cobas c pack can contain up to three reagent bottles. The center position is
position A. With the barcode facing to the rear, the left position is position B and the
right position is position C. Pipettings at different timings (R1, R2, or R3) are not
restricted to any position.
Roche Diagnostics
cobas c packs
Barcode label
Each cobas c pack is equipped with a barcode label. The analyzer scans this barcode
label each time a cassette is loaded onto the analyzer at the reagent loading station.

CAUTION reagents will be pipetted in the wrong order, leading to incorrect results. The instrument
may also be damaged.
The following data are encoded on the barcode label:

o System ID (for example, 07-3755-0)
o Lot number
o Cassette number (serial number, for example, 01983)
o Expiration date
o Bottle configuration information (on cobas c packs only)
If the barcode of a cobas c pack or other cassette is unreadable, this cassette is not
accepted. The operator is requested to close the gate.
e For information about the registration of reagents, see

Reagent registration on page B-136.
Roche Diagnostics
Handling of reagents
This section describes how the analyzer registers reagents and how it keeps track of
the remaining volumes of reagents in the course of their consumption. The
unloading and reloading of reagents is explained. The last sub-section covers
carryover evasion.
ISE reagent registration
ISE IS and ISE Dil. are stored in reagent bottles in one of the ISE reagent
compartments. At analyzer startup, the remaining volume is checked for those ISE
reagents. The reagent pipetter probe is equipped with a level detector (capacitance
method), which monitors the liquid level in the reagent bottles.
The ISE Ref. reagent bottle is not equipped with a level detector. The remaining
volume of ISE Ref. is counted down with each test.
When you replace a reagent bottle, you have to reset the remaining volume manually.
After replacement, the liquid level is not detected. Therefore, use only new bottles for
replacement. The Reagent Overview screen displays the present remaining volume
of each reagent (System Overview > Reagent Overview screen).
If the ISE IS or ISE Dil. bottle is not on board at analyzer startup or if the liquid level
falls below the limit where the bottle needs to be replaced, a yellow alarm (Reagent
Short) is issued on the Alarm screen. The AU Unit and the Reagent Overview
button turn red.
When the number of available tests is “0”, all ISE tests will be masked and thus no
subsequent measurement is possible.
e For instructions on how to replace ISE reagents, see ISE reagents on page B-52.
Notes on replacement of ISE reagents
Be sure to observe the following safety precaution:

o Incorrect results due to expired reagents or mixing reagents on page B-4
o Make sure bubbles do not form in the ISE IS and ISE Dil. bottle. If bubbles form,
reagent level may not be detected correctly by liquid level detection.
o ISE reagents are to be replaced only when the instrument is in Maintenance mode
or in Shutdown status.
o Make sure that you place the reagents in their correct positions (refer to labels on
the analyzer).
o For ISE Ref., make sure that the end of the tube touches the bottom of the bottle.
Otherwise, reagent may not be pipetted properly.
o After replacing an ISE IS or ISE Ref. bottle, reagent priming must be carried out
to fill the flow path with the new liquid.
o Whenever replacing any ISE reagent, perform an ISE calibration before you
resume routine operation.
Roche Diagnostics
Reagent registration
In order to register a new cobas c pack (or other cassette) the analyzer must read the
information stored on the barcode label. The operator clicks the Loading button in
the Reagent Setting screen and the analyzer unlocks the gate. The operator opens the
gate and scans the barcode label. After the cobas c pack is accepted, the operator
places the cassette in the reagent loading station.
e For information about the reagent loading station, see
Reagent loading station on page A-47.
If the cobas c pack currently being scanned has not been on the analyzer before, the
analyzer proceeds with the following actions:
o By reading the cassette barcode, the system checks the availability of the
corresponding test application.
o The piercer pierces the caps of the bottles in the cobas c packs.
o For standard cobas c packs, the analyzer registers the initial capacity encoded in
the barcode of the cobas c pack.
o For cobas c packs MULTI and COBAS INTEGRA cassettes, the reagent pipetter
probe performs an initial volume check—also referred to as initial cassette
volume check (ICVC)—for each of the bottles in the cobas c pack, if this ICVC
option has been selected.
Remaining volume control
After a cobas c pack has been registered the analyzer counts every pipetting out of
this cassette. Thus, the cassette’s initial number of available test is counted down.
When the number of remaining tests is lower than a defined limit, an alarm is issued
(yellow or purple alarm, according to configuration under Utility > System
(Page 2/5) > Reagent Level Check). When the number of remaining tests becomes
zero, an alarm is issued (red alarm) and the test is masked.
e For more information on monitoring the reagent status, see:
Roche Diagnostics
Unloading and reloading cobas c packs
The analyzer counts down each cassette’s initial number of available tests with every
pipetting out of that cassette. The thus obtained number of available tests is stored by
the analyzer for up to 3000 cobas c packs. If you unload a cobas c pack and reload it
later, the analyzer recognizes the cassette and continues the test count at the point
where it was unloaded.
Incorrect results and interruption of analysis due to false reagent volumes

Reload a cobas c pack only if you are sure the reagent volumes remained unchanged
CAUTION while it was not on the analyzer.
Never load a used cobas c pack onto another analyzer.
When reloading a cobas c pack onto the same analyzer, the analyzer does not
perform a second volume check—like the initial cassette volume check (ICVC) when
the cassette was new. It is assumed that the cassette’s reagent volumes remain
unchanged while the cobas c pack is not on the analyzer.
e For further instructions, see Unloading cobas c packs on page B-57
Carryover evasion
Even though all pipetter probes and reaction cells are washed and rinsed thoroughly
after each use, it could be possible that traces of sample liquid or reagent remain on
contacted parts (probes or reaction cells) and are carried over at the next pipetting.
By means of the special wash function, the cobas c 311 analyzer prevents traces of
sample liquid or reagent of one test from being carried over to another test and bias
the result of the latter.
e A current carryover evasion list is available on cobas link. Refer to the important note for
NaOHD / SMS / SmpCln 1.
e For more information on programming special washes, see:
Programming a reagent probe wash on page B-255
Programming a cell wash on page B-257
Programming a sample probe wash on page B-258
Roche Diagnostics
Reagent screen overview
Reagent screen overview
Reagents The following sections describe tasks and data that can be accessed by the screens
under the Reagent menu. The Reagent menu comprises two screens: The Reagent >
Setting screen and the Reagent > Status screen. In addition, the Reagent Overview
button on the System Overview screen as well as windows accessed via this button
are explained.
Reagent > Setting screen The Reagent > Setting screen provides detailed information about each test reagent
and position. The compiled data include the numbers of available and remaining
tests, reagent codes, lot numbers, sequence numbers, expiration dates (shelf-life) as
well as on board stability of reagents (in days). The following tasks can be performed
from this screen:
o Loading and unloading cobas c packs
o Reagent level reset of ISE reagents
o Priming ISE reagents
o Registration of Development Channel reagents
Reagent > Status screen The Reagent > Status screen provides all important data about test reagents to
monitor the reagent status on the analyzer. The data are sorted according to the
names of the applications. Moreover, there is an additional list, which provides
information about auxiliary reagents. The following task can be performed from this
screen:
o Resetting the remaining volume control for auxiliary reagents
e For a complete description of all fields and commands under the Reagent menu, refer to
the Online Help.
Reagent Setting screen on page B-139
System Overview > Reagent By changing its color, the Reagent Overview button indicates potentially insufficient
Overview button amounts of reagent. Choose this button to view details about the status of loaded
reagents.
e See Reagent Overview button on page B-143.
Roche Diagnostics
Reagent Setting screen
Reagent Setting screen
To display this screen, choose Reagent > Setting.
Figure B-66 Reagent Setting screen
This screen comprises a large test list and several buttons.

e For more information about the different fields and buttons on this screen, refer to the
Online Help of the particular field or button.
Loading Choose this button to load cobas c pack.

e For more information, see Loading cobas c packs on page B-55.
Reagent Level Reset Choose this button to reset the initial volume of ISE reagents.
To replace ISE IS or ISE Dil. on page B-52
To replace ISE reference solution (ISE Ref.) on page B-53
Reagent Prime Choose this button to prime reagents of the ISE unit. Both ISE IS and ISE Ref can be
primed.
e For more information on replacing and priming ISE reagents, see:
ISE reagents on page B-52
To perform a Reagent Prime on page B-54.
Unloading Choose this button to unload a cobas c pack.

e For more information, see Unloading cobas c packs on page B-57.
Development Channel Choose this button to reserve a Development Channel application to be assigned to a
cobas c pack MULTI.
Roche Diagnostics
Reagent Status screen
To display this screen, choose Reagent > Status.
A Test list
B Reagent Details list
C Auxiliary Reagent list (for photometric assays only)
Figure B-67 Reagent Status screen
The Reagent > Status screen displays reagent data for all tests on the analyzer. The
screen comprises a test list, a Reagent Details list (on the top right), and an Auxiliary
Reagent list (on the bottom right).
Replacing auxiliary reagents
When replacing auxiliary reagent bottles (such as cell detergent or sample probe
detergent bottles), you have to manually reset the software’s reagent volume count.
o A detergent whose expiration date has expired must not be used. Otherwise,
measurement may fail to achieve a correct result.
o Avoid adding a new detergent to the old one. Otherwise, measurement may fail to
achieve a correct result.
o Always replace empty detergent bottles with new and full ones. Otherwise the volume
cannot be correctly determined.
Follow the procedures below to replace auxiliary reagent bottles and reset their
volume count:
Roche Diagnostics
a To replace a cell detergent bottle

2 Open the left front door of the analyzer and take out the detergent bottle(s).
4
3
A Filter for CellCln I (with square end)

B Filter for CellCln II (with round end)
Figure B-68 Cleaning the detergent aspiration filters
3 Remove the tubing from the detergent bottle(s) and unscrew the filter from the
tube end.
CellCln I has a filter with a square end.

CellCln II has a filter with a round end.
4 Wash the filter with tap water.

5 Rinse the filter with deionized water.
Roche Diagnostics
6 Screw the filter onto the tube end.
Incorrect results due to incorrect insertion of the aspiration tube

If the aspiration tube is not inserted correctly, the detergent may not be dispensed
bottle.
7 Insert the tube back into the bottle.

8 Choose Reagent > Status > Reagent Volume Reset to reset the volume count.
9 Choose OK to confirm the reset.
10 Perform maintenance item (8) Cell Detergent Prime from the Utility >
Maintenance screen.
a To replace a sample probe detergent bottle

2 Put the analyzer in Maintenance mode.
Improper aspiration of detergent due to foam or air bubbles

If you shake the new detergent bottle before placing them on the analyzer, the
CAUTION detergent may form foam or air bubbles.
o Do not shake the detergent bottles before placing them on the analyzer.
4 Replace required reagent bottle. Two kinds of 70 mL bottles can be used. Sample
Cleaner 1 and Sample Cleaner 2 bottles must be placed on detergent positions 1
and 2 respectively.
5 Choose Reagent > Status > Reagent Volume Reset to reset the volume count.
6 Choose OK to confirm the reset.
Resetting initial volumes of The remaining volumes of cell detergents and other auxiliary reagents are monitored
auxiliary reagents by counting down from the initial volume of a full reagent bottle. When you place a
new reagent bottle, you always have to manually reset this volume countdown.
Always replace empty detergent bottles with new and full ones. Otherwise the volume
cannot be correctly determined.
Roche Diagnostics
Reagent Overview button
By changing its color, the Reagent Overview button in the System overview screen
indicates potentially insufficient amounts of reagent:
Button in Overview area Color Meaning

Red A reagent is empty and there is no second cobas c pack on this
Reagent Overview
analyzer.
Yellow The number of tests remaining for a reagent is below the yellow
alarm threshold (caution level).
For ISE reagents, the remaining volume is below the yellow alarm
threshold (caution level).
Purple The number of tests remaining for a reagent is below the purple
alarm level.
Table B-28 Colors of Reagent Overview button in Overview area of System Overview screen
Choose the Reagent Overview button to display the Reagent Overview window.
This window displays an overview of the consumables currently loaded on the
analyzer.
Roche Diagnostics
Reagent Overview window
Choose System Overview > Reagent Overview to display this screen. It consists of
three areas, the Reagent area, Inventory area, and ISE area.
A
B
C
A Inner subring: Cas (Cassette) D Remaining volumes of cleaner solutions

B Middle subring: Cal (Calibration) E Remaining volumes of ISE reagents
C Outer subring: QC (Quality Control)
Figure B-69 Reagent Overview window
A reagent mandatory message is displayed on the Reagent Overview screen when the
analytical unit is shown red on the System Overview screen. This may occur if a
mandatory reagent is not on board.
This function is available only, if the test of the missing reagent has been defined as
mandatory under the Utility > Module Set > Test Assignment.
Reagent area Use this area to view the status of the cobas c packs loaded on the analyzer. This area
comprises a graphic representing the reagent disk and a legend.
The graphic is divided into 2 large rings. The 14 segments of the inner large ring and
the 28 segments of the outer large ring represent the 42 positions for cobas c packs.
Each of the segments is subdivided into 3 subrings. The colors of each segment
correspond to the following statuses:
o Cas: Reagent status (inner subring)

o Cal: Status of the calibration (middle subring)
o QC: Status of the QC (outer subring)
Choosing a segment displays detailed information about the cobas c pack (Position,
Status, Test Name and Available Tests) in the center of the graphic.
Roche Diagnostics
Legend of the Reagent area The legend at the bottom of the Reagent area explains the colors represented in the
sections of the reagent disk graphic.
1. Inner subring: Cas (Cassette)
Active Reagent currently in use for this test.
Warning Remaining tests in this cobas c pack below yellow alarm level
(Utility > System (Page 2/5) > Reagent Level Check).
Zero tests, Used up The cobas c pack has been used up and is empty. There is still
reagent available in another cassette on this analyzer.
Caution There is no more reagent available for this assay on this
analyzer.
Stand-by This is a standby cassette.(a)
Free Pos. There is no cobas c pack in this position.
Expired The reagent has exceeded its expiration date.
(a) Standby reagents are reagent cassettes already on board but not in use at present. Opposite of active
reagents.
2. Middle subring: Cal (Calibration)
Valid A valid calibration is available.
Requested The reagent is requested for calibration.
Failed Calibration of the reagent has failed.
3. Outer subring: QC (Quality Control)
Valid A valid Control result is available.
Requested Requested for QC measurement.
Violated QC result is not within the confidence limits.
N.A. Not applicable (no QC values available)(a)
(a) In case QC samples have never been measured, the outer subring is shown as N.A.
Inventory area The Inventory area displays the amount of auxiliary reagents on the analyzer
previously selected on the System Overview screen.
A Bar-chart for the remaining volume

B Color-coded bar
Figure B-70 Inventory area of Reagent Overview window
Roche Diagnostics
ISE area
A
C
B
D
A Bar-chart for the remaining volume C Color-coded bar for the remaining volume of
B Color-coded bar for the calibration status ISE reagents
D Color-coded bar for the QC status
Figure B-71 ISE area of Reagent Overview window
The ISE area displays the amount of reagents by way of bar-charts. The first bar
below each bar-chart indicates the remaining volume of each ISE reagent. The second
and the third bar below the bar-charts provide additional, color-coded information
on the statuses of calibration and QC.
1. Remaining volume of ISE reagent:
Abbreviation Unit Description

IS mL Internal standard solution (ISE IS)
DIL mL Diluent
REF mL Reference solution (ISE Ref. solution)
Table B-29 ISE reagent types
2. Second colored bar: Calibration
Valid A valid calibration is available.
Requested The reagent is requested for calibration.
Failed Calibration of the reagent has failed.
3. Third colored bar: QC
Valid A valid QC result is available.
Requested Requested for QC measurement.
Violated QC result is not within the confidence limits.
N.A. Not applicable (no QC values available)(a)
(a) In case QC samples have never been measured, this is shown as N.A.
Roche Diagnostics
Detail Choose the Detail button to display the Detail window. This window displays more
detailed information about the selected cassette, namely: Reagent Type, Test Name,
Remaining Tests, Calibration Date, Calibration Type, Reagent Lot No., Reagent
Sequence Number, First Registration Date, and Expiration Date.
Figure B-72 Detail window
Date format
All dates are displayed according to the selected Set Date/Time setting on the Utility >
System screen.
Month and Year of expiration are indicated by 2 digits each. The format can be mm/yy or
yy/mm depending on the Set Date/Time setting on the Utility > System screen.
Example: For the settings dd/mm/yy and mm/dd/yy, the Expiration Date format is mm/yy.
Roche Diagnostics
Roche Diagnostics
cobas c 311 analyzer 9 Calibration
Table of contents
Calibration
This chapter provides descriptions of special tasks that are not usually part of the
daily workflow. It is meant to complement the chapter Daily operation, where
everyday tasks and common procedures for running the cobas c 311 analyzer are
described.

Calibration concept ..................................................................................................... B-151
Triggers for automatic calibration requests ...................................................... B-152
Calibration concept .............................................................................................. B-153
Calibration rules for the photometric unit .................................................. B-154
ISE calibration concept .................................................................................. B-154
Lot and cassette calibrations for the photometric unit .............................. B-155
Calibration masking ............................................................................................. B-155
Calibration Screen Overview ..................................................................................... B-156
Calibration Status screen ............................................................................................ B-156
Requesting and cancelling calibrations manually ............................................ B-157
Selecting tests for start-up calibrations .............................................................. B-158
Reviewing calibration data .................................................................................. B-159
Checking calibrations of photometric tests ................................................ B-159
Checking calibrations of ISE tests ................................................................ B-163
Calibration Factors ............................................................................................... B-165
Calibration Install screen ........................................................................................... B-166
Loading calibrator data ........................................................................................ B-167
Checking information about currently installed calibrators .......................... B-169
Editing concentration values ............................................................................... B-170
Reassignment of calibrator values ...................................................................... B-172
ISE calibration ....................................................................................................... B-173
Calibration Calibrator screen .................................................................................... B-174
Assigning calibrator positions ............................................................................. B-175
System Overview screen ............................................................................................. B-176
Calibrating tests during operation ...................................................................... B-176
Roche Diagnostics
9 Calibration cobas c 311 analyzer
Table of contents
Roche Diagnostics
Calibration concept
Calibration concept
Calibration The following section gives an overview of the calibration concept applied by the
cobas c 311 analyzer; it provides you with a basic understanding of the various
calibration functionalities implemented on the analyzer and its software.
e For instructions on how to perform calibrations, see Calibration And QC Select button on
page B-58.
What is calibration? Calibration is the process that establishes a relation between measurement values
(such as absorbance values) and corresponding results (concentration of an analyte).
This process may comprise the complete setting up of a new calibration curve or it is
only the update of one or two parameters of an existing calibration curve.—In either
case the term calibration is appropriate.
Automatic calibration The relation between measurement values and results is subject to various
environment and reagent conditions and may drift in the course of time. Therefore it
is necessary to repeat calibrations regularly. To keep the resulting calibration
management simple and efficient the analyzer automatically recommends
calibrations.
To get an overview of the functions provided by the cobas c 311 analyzer for
automating calibration refer to the following section.
e See Triggers for automatic calibration requests on page B-152.
Manually requesting calibration The operator can manually order a calibration. It is possible to request a single test
for calibration or a group of calibration tests.
If a predefined set of calibration tests are to be carried out at the start of analysis run,
it is advisable to define a start-up setting calibration. The tests for Start up calibration
are defined under Calibration > Status > Start Up Setting.
e See To select tests for start-up group calibration on page B-158.
The following calibration settings are defined under the Utility > Application >
Calib. screen.
e See Description of application parameters - Calib. tab on page B-224.
Validation of calibration After a calibration is performed, it needs to be validated. The analyzer performs this
task by means of automatic calibration checks. Whenever it detects an irregular
condition or result, the calibration is classified as failed, a calibration alarm is issued,
and the calibration is automatically recommended to be repeated.
Calibration masking If a calibration fails one or more quality criteria applied in the validation process,
tests are no longer performed with the affected reagent. This is achieved
automatically by means of the auto masking function.
e For more information, see Calibration masking on page B-155.
Roche Diagnostics
Calibration concept
Triggers for automatic calibration requests
The following conditions (calibration causes) will automatically trigger a calibration

request from the analyzer:
o Automatic calibration at change of reagents (Changeover calibration):
O Calibration at lot change
O Calibration at cassette change
o Automatic calibration without reagent change:
O Calibration in regular intervals (Timeout)
O Calibration in combination with Preventive action (Calib Now)
O Calibration due to failed QC (QC-triggered calibration (QC Violation))
o Automatic recommendation for recalibration if a calibration failed (Failed)
The different calibration functions can be combined. Only for automatic calibration
without reagent change you have to decide for one workflow: Timeout calibration or
QC violation.
If two or more calibration requests are posed simultaneously for one reagent, only
one of them is indicated according to the following priority:
Failed > Changeover > Timeout / QC Violation > Calib Now > Manual.
Failed If a calibration fails one or more quality criteria, this calibration gets the status Failed.
Failed calibration data are not available for the corresponding cobas c pack.
Changeover calibration Calibrations have to be performed if certain physical events occur. These include:
o A change in reagent lot (of cobas c packs)
o A change of a cobas c pack (regardless of the lot; if requested by application)
Timeout Calibrations are performed at regular intervals to compensate changes over time in
reagents and in the measurement systems. Timeout calibrations can be performed for
lot timeout and for cassette timeout.
QC-triggered calibration Calibration will be initiated if the QC results are outside the confidence limit. Three
(QC Violation) different controls can be defined.
For each application you have to decide whether calibration should be performed
time-triggered (Timeout) or QC-triggered (QC violation).
We recommend to decide for one calibration workflow—time-triggered or QC-

triggered—for all applications. Only few specific applications require a time-triggered
calibration.
If a new application is loaded, time-triggered calibration is preselected and the

intervals recommended by Roche are predefined. If you prefer a workflow with QC-
triggered calibration you have to activate QC violation.
Calib Now This automatic calibration function is active only if Preventive Action is activated in
the System Overview screen. If a calibration runs out of time during the period
specified in the Remaining Time box on the Calibration > Status screen, the
analyzer recommends a calibration indicating Calib Now as a calibration trigger.
e For information on the necessary QC violation settings, see Auto Calibration on
page B-225.
Roche Diagnostics
Calibration concept
Calibration concept
Types of calibration curves There are six different types of calibration curves possible on a cobas c 311 analyzer.
That is, there are six different types of mathematical functions possible to describe
the relation between measurement value and result. In this document and in the user
interface (UI), these types of calibration curves are called calibration types. The
names of the calibration types are:
Linear RCM2T1 Spline

RCM (Reaction Calculation Mode) RCM2T2 Line Graph
Table B-30 Calibration types for photometric tests
Each calibration type corresponds to one type of mathematical function. For

example, Linear corresponds to a linear equation, RCM1 to an exponential function.
e For more details, refer to the COBI CD.
Calibration curve parameters A specific calibration curve is defined by its calibration type (mathematical function)
and its parameters. The names of these parameters in the user interface are:
o S1Abs., K, A, B, C, (L, H, I only for serum indices)
A Linear calibration curve, for example, is defined by two parameters (S1Abs. and K),
an RCM calibration curve is defined by four, and a Spline can require up to six
parameters. When the analyzer performs a calibration, it redetermines these
parameters to fit the calibration curve to new measurement values.
For the Spline calibration curve the calculation are neither printed out nor displayed on the
Calibration Result screen. Only S1Abs. is displayed.
Calibration methods Calibrations are performed with varying numbers of calibrators. Up to six calibrators
are used for a full calibration of certain photometric tests. However, not all calibrators
available for a test need to be used in every calibration. To define which calibrators
are used there is a choice of up to four different calibration methods.
The availability of calibration methods depends on the kind of test that has to be
calibrated. The following table displays all calibration methods and the
corresponding calibrators.
Photometric tests ISE tests

Blank Std (1)(a) is used Only ISE Comp. [Std (3)] is used
(not recommended in US)
Span Only one calibrator out of Not available
Std (2)-Std (6)(b) is used
2 Point Std (1) and a second calibrator are ISE Low [Std (1)] and ISE High
used [Std (2)] are used
Full All calibrators [Std (1)-Std (6)] are ISE Low [Std(1)], ISE High [Std(2)],
used (for nonlinear calibration types) and ISE Comp. [Std (3)] are used
(global use)
ISE Low [Std(1)], ISE High [Std(2)],
and ISE High (compensated)[Std (3)]
are used (in US only)
(a) Std (1) is the first standard solution, that is, the calibrator with the lowest analyte concentration. For
most photometric applications water is used as a blank calibrator.
(b) Std (2)-Std (6) refers to calibrators assigned to an application under Utility > Application > Others.
Roche Diagnostics
Calibration concept
Calibration rules for the photometric unit

o Calibration is best done as a part of the daily preroutine operation. However, it
can be done at any time during operation as well.
o Multi-calibrators are usually used. Calibrator data is downloaded via
cobas link /cobas e-library.
o Calibrations are carried out in duplicate.
o Hitachi micro cups are not applicable to calibrators and QCs.
o Barcoded calibrators:
Roche calibrators are always supplied with barcode labels (inserted in the
calibrator kit). A barcode for water is also available but must be ordered
separately.
The labels must be placed on a tube.
o Non-barcoded calibrators can be used as well. In this case calibrators have to be
assigned to specific positions (position assignment).
o Calibrators can be used several times for calibrations.
ISE calibration concept
ISE calibrators can be used with or without barcodes. The labels for the ISE Standards 1
and 2 (ISE Low and ISE High) can be found on the back of the boxes. The label for the
ISE Comp. can be found inside the box.
o Calibrations are carried out in triplicate.
Full calibration Full calibration for Na+, K+, and Cl- requires the following 3 calibrator solutions:
o ISE Standard 1 (ISE Low)
o ISE Standard 2 (ISE High)
o ISE Standard 3 (ISE Comp.)
o ISE Standard 3 (ISE High) for US only
The slope of the calibration curve is calculated from ISE Standards 1 and 2. ISE Low
and ISE High are aqueous standards. ISE Comp. / ISE High (compensated) is
designed to reduce matrix effects. A full calibration is required every 24 hours.
One-point calibration The ISE internal standard (ISE IS) is measured before and after each routine sample
(only one measurement for sample analyses in succession). These measurements are
used to correct for system-related drifts (junction potential differences, differences in
electrode conditions, etc.).
The ISE IS is also measured during calibration as well.
Sample type specific ISE It is possible to set up and use two independent sets of calibration curves (ISE-A and
calibration curves ISE-B) for different sample types for Na+, K+, and Cl-.
If only one calibration curve is used for the different sample types, only one
calibration is performed.
e For information on configuration and assignment of calibrations, see
ISE calibration on page B-173
Roche Diagnostics
Calibration concept
Lot and cassette calibrations for the photometric unit
Lot calibration Lot calibration data are reagent lot specific for the test. Lot calibration data are
transferred to other cobas c packs belonging to the same reagent lot. The lot
calibration data are applied to result calculations of all patient samples and controls.
A lot calibration can only be generated from a fresh cobas c pack, which means that
the calibration must be performed within 24 hours after the cassette has been loaded
on the analyzer.
Cassette calibration Cassette calibration data are cassette-specific. A cassette calibration is generated if a
cobas c pack is calibrated which is loaded on the analyzer more than 24 hours ago
and all calibration quality criteria are met.
Most of the photometric tests need to be calibrated only if the reagent lot is changed
(lot calibration). Some of the tests, however, need to be calibrated whenever a new
cobas c pack is inserted (cassette calibration).
Newest calibration Newest calibration is a function that permits to replace empty cobas c packs without
performing a calibration.
For a reagent cassette for which no applicable calibration data exists, the newest
calibration result is transferred at the time of reagent registration. This function is
used to avoid the following situation: A cassette of a new lot, that was loaded on the
system, does not have any calibration data. Always the newest calibration data (the
data of the last valid lot calibration) are transferred.
Calibration masking
Automatic calibration masking is a function which masks a cobas c pack. This

function is activated (or deactivated) for the entire analyzer under Utility >
System (Page 2/5) > Calib Mask Setting. If activated, the function can be selected
individually for each application on the Utility > Application > Calib. screen.
Failed calibrations If a calibration is successful, the calibration data are available for the measurement of
patient samples and controls. If a calibration fails one or more quality criteria, this
calibration gets the status Failed. Failed calibration data are not available for the
corresponding cobas c pack.
If automatic calibration masking is activated, the corresponding test with the Failed
calibration data is masked. If automatic calibration masking is not activated, the test
is not masked but data alarms are attached to the results.
The Failed calibration can be rejected by the operator (Reject button on
Calibration > Status). In this case, the last successful calibration will be used.
However, the original calibration recommendation still remains for the cobas c pack.
Roche Diagnostics
Calibration Screen Overview
Calibration Screen Overview
Calibration The Calibration menu contains three screens: Calibration > Status, Calibration >
Calibrator, and Calibration > Install. This chapter describes important commands
accessed via these screens as well as various information displayed on them.However,
this chapter does not cover all possible commands. For a complete description of all
fields of the software’s user interface, refer to the Online Help.
e For more information about the calibration menu, refer to the Online Help.
Calibration Status screen
The following sections explain certain tasks associated with the Calibration > Status
screen. Not all tasks are described but the most important ones.
e For a complete description of all elements of the user interface, refer to the Online Help.
To display this screen choose Calibration > Status.
A Exclamation Point column header
Figure B-73 Calibration > Status screen
e For information about particular tasks associated with this screen, see:
Requesting and cancelling calibrations manually on page B-157
Reviewing calibration data on page B-159
Selecting tests for start-up calibrations on page B-158
Calibration Factors on page B-165.
Exclamation Point
This column header turns yellow if the displayed status list should be updated. The
displayed information may be out-of-date, e.g., if a calibration has been performed in the
meantime. Choose the Exclamation Point to update the status list.
Roche Diagnostics
Requesting and cancelling calibrations manually
According to the intended use, calibrations will be automatically requested from the
analyzer and from the operator via the System Overview screen. Regardless of these
requests from the analyzer calibrations can be manually selected and deselected as
well.
a To request a calibration for a test manually

2 Select the test and the cobas c pack that needs to be calibrated from the list.
The selected line is highlighted in blue.
3 Select the appropriate button in the Method area for a Blank, 2 Point, Full, or
Span calibration.
The selected option appears in the Calib. Method column highlighted in green,
the Cause column indicates Manual, and the Save button turns yellow.
4 To request calibrations for additional reagents and tests repeat steps 2 and 3.
5 Choose Save.
All listed tests and reagents that have an entry in the Calib. Method column
highlighted in green correspond to a requested calibration.
a To cancel a calibration request manually

2 Select the reagent and test whose calibration request is to be cancelled.
The selected line is highlighted in blue, the entry in the Calib. Method column is
highlighted in green, and the corresponding button in the Method area is
highlighted in white.
3 Select the highlighted button in the Method area.
The entries in the Calib. Method and Cause column for this reagent disappear
and the Save button turns yellow.
4 To cancel further calibration requests repeat steps 2 and 3.
Roche Diagnostics
Selecting tests for start-up calibrations
The start-up calibration function allows you to select a number of tests and treat
them as a group. Tests selected for start-up calibration will be requested for
calibration when the Start Up button is chosen either from the Calibration and QC
Select window, or directly from Calibration > Status.
The set of tests that are selected in a start-up calibration group, including the
respective calibration methods, is defined under the Calibration > Status > Start Up
Setting window.
a To select tests for start-up group calibration

1 Choose Calibration > Status > Start Up Setting.
Figure B-74 Start Up Setting window
2 Choose Start Up Group Setting.

3 Select a Start Up Group.
4 Enter a group name and choose OK.
Up to seven groups can be set in the Start Up Group Setting window.
5 Select the Start Up Group from the drop-down list.

6 Select one or more tests from the list and specify your calibration method.
The selected test is highlighted in blue and the calibration method is highlighted in
green. For ISE assay, specify Full.
7 Choose Update.
8 Repeat steps 2-7 for each group.
9 After completing settings for all of the groups, choose OK.
10 Select Start Up Group from the drop-down box and choose Start Up on the
Calibration > Status screen to activate the selected calibrations or from the
Calibration and QC Select button on the System Overview screen.
11 Choose Save to confirm the start-up calibrations.
Roche Diagnostics
Reviewing calibration data
After a calibration is completed it must be reviewed. Details for each calibration

performed on any of the analyzer’s units can be retrieved from the Calibration >
Status screen. The following sections describe the possibilities to check calibration
data according to the different kinds of test calibrated.
e For further information, see:
Checking calibrations of photometric tests on page B-159
Checking calibrations of ISE tests on page B-163.
Checking calibrations of photometric tests

For each successful calibration of a photometric test, the following information is
available:
o Calibration Monitor report: The report is printed out automatically (depending
on the setting on Utility > System (Page 4/5) > Automatic Printout).
o Calibration factor: Parameters that determine shape of the calibration curve.
e See Calibration Factors on page B-165.
o Calibration curve: Mathematical relation between the measured signal (for
example, absorbance or rate of change in absorbance) and the corresponding
concentration value for the concerned analyte.
o Reaction monitor: A graph showing the measured absorbance in the course of a
test measurement.
o Calibration trace: A graph used to review the measurements of the 50 most
recent calibrations for a specific test. It shows signal values for both the Std (1)
calibrator and the calibrator with the maximum concentration on one plot.
a To review photometric Calibration Monitor reports

1 The Calibration Monitor report is printed automatically after the calibration
results are present. It is also displayed in the Print View window. Choose Print
(global button) > View.
2 Review the printout using the following information.
o Check for any calibration alarm listed below the results. In case a calibration
alarm occurred, take the necessary remedial actions (see Alarms for
calibrations on page D-28).
o Compare the calibration results to previous calibrations if available.
e Please refer to the Online Help for an example and a description of the Calibration
Monitor Report.
Roche Diagnostics
a To review calibration data

2 Select a photometric test from the list on Calibration > Status.
3 Choose Calibration Result to display the Calibration Result window.
S1Abs., K, A, B, and C = Calibration curve parameters (S1Abs. and K for linear calibration
curves)
Figure B-75 Calibration Result (Photometry) window
This window gives information about the most recent calibrations for the
displayed photometric tests.
o To display the calibration curve of a selected test choose Working
Information.
o To display the calibration factors for the cassette calibration, lot calibration,
and newest calibration of a selected test choose Calibration Factor.
e For more details about calibration factors, see
Calibration curve parameters on page B-153
Calibration Factors on page B-165.
Roche Diagnostics
a To review measurement details of the most recent calibration

3 Choose Reaction Monitor to display the Reaction Monitor window.
This window displays reaction graphs for each of the duplicate measurements of
each calibrator used for the calibration selected.
Figure B-76 Reaction Monitor window of a 2 Point End assay
4 Use the drop-down list above the graph to select a specific measurement. The
extensions 1st and 2nd in the list correspond to the first and second measurement
of each calibrator, respectively.
e For a complete description of all fields and buttons, refer to the Online Help.
e For background information about photometric principles, refer to the COBI CD.
The measuring points of the reaction monitor of a calibration can be printed out: First,
select a test from the Calibration > Status screen, then, choose Print (global button),
select Reaction Monitor from the list on the left, and choose Print.
Roche Diagnostics
a To review results of previous calibrations

3 In order to review the results of previous calibrations of the selected test, choose
Calibration Trace.
Figure B-77 Calibration Trace window
This window displays a graph showing calibration results for both the Std (1)
calibrator and the calibrator with the maximum concentration on one plot.
The left and right y-axes are scaled independently:
o The left axis refers to the Std (1) calibrator represented by .
In case of a rate assay, it indicates the primary wavelength absorbance at
photometric measuring point 1 of Std (1).
o The right axis refers to the maximum calibrator represented by .
The calibration trace list can be printed out. First, select a test from the Calibration >
Status screen, then, choose Print (global button), select Calibration Trace from the list
on the left, enter date range, and choose Print.
Roche Diagnostics
Checking calibrations of ISE tests

For each successful calibration of an ISE test, the following information is available:
o Calibration Monitor report: The report is printed out automatically (depending
on the setting on Utility > System (Page 4/5) > Automatic Printout).
o Calibration Result button — Working Information (ISE): Results from the
most recent successful ISE calibration for the test selected.
o Calibration trace: A graph used to review the measurements of the 50 most recent
calibrations for a specific test. It shows both the measured data for the selected
test’s compensator ISE Comp. (in mmol/L) and slope values (in mV) on one plot.
For US only, ISE High (compensated) is used instead of ISE Comp.
a To review ISE Calibration Monitor reports

1 The Calibration Monitor report is printed automatically after the calibration
results are available. It is also displayed in the Print View window. Choose Print
(global button) > View.
2 Review the printout using the following information.
o Check for any calibration alarm listed below the results. In case a calibration
alarm occurred, take the necessary remedial actions (see Alarms for
calibrations on page D-28).
o Compare the calibration results to previous calibrations if available.
e Please refer to the Online Help for an example and a description of the Calibration
Monitor Report.
a To review calibration data

2 Select an ISE test from the list on Calibration > Status.
The entries ISE-A and ISE-B refer to two different calibration curves that can be
assigned to different sample types. For example, ISE-A is assigned to serum/plasma
and ISE-B to urine samples. This assignment is set on Utility > System (Page 3/5) >
ISE Calib Setting.
Roche Diagnostics
3 Choose Calibration Result to display the Working Information (ISE) window.
Figure B-78 Working Information (ISE) window
This window displays information about the most recent successful ISE
calibration: Electromotive force (EMF), slope, and target concentration values.
The three Compensated Value text boxes display the difference between the
target value of the ISE compensator [ISE Std (3)] and its measured values for Na+,
K+, and Cl-. This difference is added to all measured routine samples and
controls. This is done to compensate for the fact that the internal standard
(ISE IS) and the calibrators Std (1) and Std (2) are aqueous solutions whereas the
patient samples being measured are serum-based solutions.
The slope of the calibration curve is calculated from ISE Standards 1 and 2.
ISE Comp. is designed to reduce matrix effects. It only affects the intercept and
not the slope.
a To review results of previous ISE calibrations

2 Select an ISE test from the list on Calibration > Status.
3 Choose Calibration Trace to open the Calibration Trace window.
4 Select a test from the drop-down list on the top left of the window.
The graph shows calibration results for the selected ISE test. The left and right
y-axes are scaled independently: The left axis refers to the measured
concentration values of the ISE compensator [ISE Std (3)]represented by . The
right axis refers to the calculated slope values represented by .
Roche Diagnostics
Calibration Factors
The term calibration factors refers to coefficients (S1Abs, K, A, B, C) used for setting
up calibration curves for photometric tests. The analyzer stores calibration factors for
each calibration curve of all registered cobas c packs.
The following kinds of calibration factors are available: Cassette, Lot, and Newest.
Lot calibration factors Lot calibration factors are reagent lot specific for the test. Lot calibration factors are
transferred to other cassettes belonging to the same reagent lot. The lot calibration
data are applied to result calculations of all patient samples and controls.
A lot calibration can only be generated from a fresh cobas c pack, which means that
the calibration must be performed within 24 hours after the cassette has been loaded
on the analyzer.
Cassette calibration factors Cassette calibration factors are cassette-specific. A cassette calibration is generated
when a cobas c pack is calibrated which is older than 24 hours after being loaded on
the analyzer for the first time and all calibration quality criteria are met.
Most of the photometric tests need to be calibrated only when the reagent lot is
changed (lot calibration). Some tests, however, need to be calibrated whenever a new
cobas c pack is inserted (cassette calibration).
Newest calibration factors Newest calibration is a function that allows you to replace empty cobas c packs
without performing a calibration (if no changeover calibration is recommended for
this application).
For a reagent cassette for which no applicable calibration data exists, the newest
calibration is transferred at the time of reagent registration. The newest calibration is
always the last generated lot calibration of this test. This is used to prevent that a
cobas c pack of a new lot loaded on the analyzer does not have any calibration data.
Always the newest calibration data are transferred.
a To check calibration factors

2 Select a photometric test from the test list.
3 Choose Calibration Result.
4 On the Calibration Result window, choose Calibration Factor.
The Calibration Factor window opens.
Roche Diagnostics
Calibration Install screen
The following sections contain certain tasks associated with the Calibration > Install
To display this screen choose Calibration > Install.
Figure B-79 Calibration > Install
The Calibration > Install screen is used to review information about currently
registered calibrators, to update calibrator data, and to install new calibrators.
Roche Diagnostics
Loading calibrator data
Information regarding calibrator codes, lot numbers, expiration dates, and

concentration values can be downloaded to the analyzer from cobas link. An
operator ID of supervisor level or higher is required for this operation.
This operation is a part of the installation process for a new application.
e For an overview of the complete installation process of a new application, see:
Loading or updating applications on page B-214.
In case calibrators are used without barcodes, assign the calibrator positions manually.
a To download calibrator data from cobas link

1 Make sure that the analyzer is in standby.
2 Choose Calibration > Install > Download to open the Download window.
Figure B-80 Download window for calibrator data
3 Select one of the available search options (Required Item, Calibrator Name, Lot
Number, or Release Date).
o Lot Number is the recommended search condition.
o The Lot Number must always be entered with 8 digits. The last two digits are
zeros (XXXXXX00).
o The option Release Date refers to the date when the calibrator was released by
Roche Diagnostics.
Roche Diagnostics
4 Choose Search to start searching for the selected criteria. The search results are
displayed.
Figure B-81 Download window with search results
In the column Note you can find additional information about the calibrator such
as reason for change.
To change the order of the list select the Sort By option.
5 Select the Selection check box of each list item to be downloaded.
6 Choose Download and confirm with OK.
7 Choose OK to start the download process.

8 Choose Close to return to the Calibration > Install screen and verify the
downloaded information has been registered correctly.
9 Choose OK to save the data.
Using calibrators without barcodes requires the assignment of the calibrator to a
specific position.
e See To assign a calibrator to a specific position on page B-175.
Roche Diagnostics
a To add calibrators manually (without cobas link)

1 Select a blank line from the control list on the Calibration > Install screen.
2 Choose Add.
3 Type all necessary data in the Add Calibrator window.
The Code range is from 1-998. Ensure that the calibrator code is not already in
use.
Figure B-83 Add Calibrator window
4 Choose OK. The new calibrator appears on the calibrator list.

Using calibrators without barcodes requires the assignment of the calibrator to a
specific position.
5 Enter the concentration values of the calibrator.
e See: To enter or edit concentration values of a calibrator on page B-170
e See: To assign a calibrator to a specific position on page B-175.
Checking information about currently installed calibrators
This section describes how to check registered calibrator data.
In case calibrators are used without barcodes, assign the calibrator positions manually.
a To check registered calibrator data

1 Choose Calibration > Install.
2 Select a calibrator from the list on the left.
The list on the right displays the registered concentration values for this
calibrator.
3 In order to look up a calibrator’s calibrator code, position, lot number, or
expiration date choose Calibration > Calibrator.
Roche Diagnostics
Editing concentration values
The concentration value of a calibrator can be edited on the Calibration > Install
screen. You can use this function to define the number of decimal places for Std (1)
used for reportable data.
a To enter or edit concentration values of a calibrator

1 Choose Calibration > Install.
2 Select the calibrator to be edited from the list on the left.
3 Choose Edit. The Edit Calibrator window opens.
Figure B-84 Edit Calibrator window
4 Select a test (analyte) from the list whose calibrator concentration value is to be
entered or edited.
5 Select a box in the Std Concentration area and type the appropriate
concentration value. Observe the respective unit of measure displayed below the
Std Concentration area.
Std (1) is used for the blank calibrator. Std (2) through Std (6) are used for all
other calibrators.
The number of decimal places used for Std (1) defines the number of decimal places
used for reportable data.
It is recommended to select the number of decimal places at the time of installing the
application.
6 After the value is entered, complete the input by choosing Update.

7 If you need to edit additional tests, repeat steps 4 through 6.
Roche Diagnostics
8 Choose OK to save all changes and close the window.
Incorrect results due to wrong calibration

After changing the calibrator concentration for any calibrator [Std (1)-Std (6)] or the
CAUTION number of decimal places for Std (1), always recalibrate the test with a full calibration
in order to ensure no incorrect results are reported.
Generate a new lot calibration for the test.
9 Calibrate the test.

10 Perform QC measurements.
No update of manually edited concentration values

In case a value has been manually edited, this value will not be updated when you
download new calibrator values from cobas link.
If you want to return to the original concentration value, delete the calibrator and
download it again from cobas link. Perform calibration before you resume routine
operation.
a To change the decimal places or calibrator target values for a previously

calibrated application
Incorrect results due to wrong calibration

You can change the decimal places or calibrator target values after an application has
CAUTION been installed. However, if the decimal places or calibrator target values are changed after
the test in question has already been calibrated, we strongly recommend deleting that test
application and reinstalling it.
After changing the calibrator target values or the number of decimal places for Std (1), the
calibration is immediately updated, that is, even before the actual calibration measurement
is performed.
o After changing the decimal places or calibrator target values, always recalibrate and
run controls in order to ensure no incorrect results are reported.
o Make sure to perform the calibration measurement prior to any other determinations.
1 Backup the database and delete patient data (System Overview > Sample Data
Clear > Backup and Clear).
If Sample data clear is executed, all the records of the samples are deleted and QC
data are moved to the QC View.
e For details see
Sample Data Clear button on page B-50.
2 Unload all the cobas c packs for this test (Reagent > Setting > Unloading).
e For details see Unloading cobas c packs on page B-57.
3 Delete the test application (Utility > Application > Delete).

4 Reinstall the test application (Utility > Application > Download).
e For details see Loading or updating applications on page B-214.
Roche Diagnostics
5 Load new cobas c packs.

e For details see Loading cobas c packs on page B-55.
Any cobas c packs for this test that were already in use on the analyzer cannot be
reloaded onto the analyzer after the test has been deleted.
6 Install the calibrator values for this test under Calibration > Install > Download.
e For details see Loading calibrator data on page B-167.
7 Change the decimal places of calibrator 1 (Std (1) (Calibration > Install > Edit).
8 Install the control values for this test under QC > Install > Download.
e For details see Loading control data on page B-203.
9 Calibrate the test and perform control measurements.

e For details see Requesting calibration and QC and printing load lists on page B-59.
Reassignment of calibrator values
If concentration values for a particular calibrator have been reassigned, you are
informed by means of the cobas e-library (Value Sheets or Important Notes). In this
case you have to reassign the calibrator values on the cobas c 311 analyzer.
Calibrator values are not updated by download

When downloading reassigned calibrator values from cobas link, the cobas c 311
analyzer will not overwrite the existing values. The values will not be updated for this
particular lot.
To update calibrator values you must reassign the calibrator values manually.
e For reassign calibrator values, see To reassign calibrator values manually on page B-172
a To reassign calibrator values manually

1 Enter the calibrator values for a calibrator that must be reassigned on the Edit
Calibrator window.
e See To change the decimal places or calibrator target values for a previously calibrated
application on page B-171
2 Perform a new lot calibration for the current reagent lot and for all previously
registered reagent lots that will be reused.
e See Requesting and cancelling calibrations manually on page B-157
3 In addition perform a cassette calibration for the currently used cobas c pack and
for all temporary unloaded cobas c packs.
e See Requesting and cancelling calibrations manually on page B-157
Roche Diagnostics
ISE calibration
ISE calibrators low and high can be used with or without barcode labels. Without a
barcode you have to register the calibrators, assign a calibrator position to them, and
enter the relevant concentration values for each calibrator as described above.
When the analyzer configuration is completed, the three calibrators —ISE Low,
ISE High, and ISE Comp.—used in an ISE calibration must always be placed in their
assigned positions.
e For details see:
Editing concentration values on page B-170
Assigning calibrator positions on page B-175.
Two ISE calibration curves For ISE tests it is possible to apply one of two independent calibration curves. After
installation and assignment, the respective calibrator values are displayed under
ISE-A and ISE-B on Utility > Application > Other.
The assignment of one or the other calibration curve to a certain sample type is set on
Utility > System (Page 3/5) > ISE Calib Setting.
Figure B-85 Utility > System (Page 3/5) > ISE Calib Setting window
Roche Diagnostics
Calibration Calibrator screen
The following sections contain certain tasks associated with the Calibration >
Calibrator screen. Not all tasks are described, but the most important ones.
To display this screen choose Calibration > Calibrator.
Figure B-86 Calibration > Calibrator window
The Calibration > Calibrator screen is used to review information about currently
registered calibrators and to manually assign calibrators to specific positions. The
position assignment is necessary for calibrators that are used without barcode
identification.
Assigning calibrator positions on page B-175.
Roche Diagnostics
Assigning calibrator positions
Use the following procedure to assign a calibrator to a position if you are using cups
without a barcode, or if the analyzer cannot read the barcode on the calibrator.
It is possible to do a calibration with barcoded and non-barcoded calibrators mixed.

However, you have to assign the position of the non-barcoded calibrator and no position
should be assigned for the barcoded calibrator. If you put a barcoded container on a
position which was assigned manually, the calibration is not measured.
a To assign a calibrator to a specific position

1 Choose Calibration > Calibrator > Position Assignment.
Figure B-87 Calibrator Position Assignment window
2 Select the calibrator to be assigned to a position from the list on the left.
3 Select a position from the list on the right. The position selected for the
assignment has to be an empty line in the list.
4 Choose Assign to assign the selected calibrator to the selected position.
To undo the assignment choose Remove or choose Cancel to leave the Calibrator
Position Assignment window without saving any changes.
5 To assign further calibrators repeat steps 2 to 4.
6 After all necessary assignments are completed, choose OK to save the changes.
Roche Diagnostics
The following section explains calibration tasks associated with the System Overview
screen.
Choose the graphical icon representing the configuration in the status line (top left of
the screen), or press F12 to display the System Overview screen.
Calibrating tests during operation
Calibration is usually performed at the beginning of routine operation before sample

processing begins. However, it can be done any time during routine operation as well.
The procedure for calibrating tests during operation is essentially the same as the
calibration at the beginning of routine operation:
a To perform calibrations during operation

1 Request the recommended calibrations via the Calibration and QC Selection
button (highlighted yellow) on the System Overview screen.
2 Select an option from the Load List area to select the respective lists for printing.
3 Print the selected load lists.
4 Choose Pause/Scan (global button), then Pause. Wait for the green Access
Sample Disk lamp to turn on.
5 Load calibrators onto the sample disk as described on the Calibration load list.
6 Choose Start (global button). Choose Start on the Start Conditions screen. The
Start screen closes and the calibration and control run begins.
e For a detailed description of the calibration process at the beginning of routine operation,
see:
Calibration And QC Select button on page B-58
Requesting calibration and QC and printing load lists on page B-59
Measuring calibrators and controls on page B-62.
Roche Diagnostics
cobas c 311 analyzer 10 QC
Table of contents
QC
This chapter explains certain tasks associated with the QC menu. Not all tasks are
described but the most important ones.

QC concept .................................................................................................................. B-179
QC methods ........................................................................................................... B-179
System implementations for QC measurements .............................................. B-179
Definitions concerning QC ................................................................................. B-180
Accumulation of QC measurement data ........................................................... B-181
Handling of QC results ........................................................................................ B-182
Working in barcode or non-barcode mode ...................................................... B-183
QC Status screen ......................................................................................................... B-184
Timeout QC ........................................................................................................... B-185
Requesting QC measurements ............................................................................ B-186
QC Run Status screen ................................................................................................. B-188
QC Individual screen .................................................................................................. B-190
Excluding an individual QC point or adding a comment ............................... B-192
Configuring and using realtime QC ................................................................... B-193
Configuring realtime QC ..................................................................................... B-196
Accumulation of QC results ................................................................................ B-198
System settings for QC accumulation .......................................................... B-198
Accumulating QC results .............................................................................. B-198
QC Cumulative screen ............................................................................................... B-199
QC Control screen ...................................................................................................... B-200
QC Install screen ......................................................................................................... B-202
Loading control data ............................................................................................ B-203
Editing control values ........................................................................................... B-206
Reassignment of control values .......................................................................... B-207
Activating control tests ........................................................................................ B-208
Programming auto QC measurements .................................................................... B-209
Roche Diagnostics
10 QC cobas c 311 analyzer
Table of contents
Roche Diagnostics
QC concept
QC concept
Regularly perform QC measurements to continually monitor the instrument

performance. After measurement of QC samples, data can either be transferred to
and processed on a Host or they can be processed on the analyzer.
QC methods
The following QC methods are available on a cobas c 311 analyzer: Individual (intra-
day) QC, cumulative (long-term) QC, and realtime QC.
Individual and cumulative QC All results of QC measurements can be viewed on the QC > Run Status screen and
the QC > Individual screen. It is recommended to transfer QC data at the end of a
day from the individual QC to the cumulative QC. Under cumulative QC you find all
the long-term quality control data stored on the analyzer.
e For more information see:
QC Run Status screen on page B-188
QC Individual screen on page B-190
QC Cumulative screen on page B-199
e For more details on the accumulation of QC data (from individual to cumulative QC), see:
Accumulation of QC measurement data on page B-181
Accumulation of QC results on page B-198.
Realtime QC Independent of individual and cumulative QC, the realtime QC function allows the
evaluation of QC measurement immediately after their results become available
(realtime) utilizing the Westgard algorithm.
Realtime QC for one test always uses two kinds of controls and compares QC results
against the controls’ known standard deviation (SD) and mean values.
e For more information on realtime QC, see Configuring and using realtime QC on
page B-193.
System implementations for QC measurements
In addition to the QC methods explained above, there are six types of

implementations which are available to manage the measurement of QC samples:
o Routine QC
o Standby reagent QC
o Timeout QC
o Automatic QC
o QC after calibration
o Manual QC
Roche Diagnostics
QC concept
Routine QC Each test has one or more controls assigned to it. Moreover, a test must be not only
assigned to a control but also activated for that control to make a QC measurement
possible. Routine QC comprises all activated tests of all installed controls. You can
request a QC measurement for all of these tests—for example at the beginning of a
work shift—with one single command (System Overview > Calibration and QC
Select > Routine QC).
e For more information about routine QC, see:
Requesting QC measurements on page B-186
Standby reagent QC QC measurements can be requested individually for standby cobas c packs. Standby
cobas c packs are already on board but not in use at present.
e For more information about standby reagent QC, see:
Timeout QC QC measurements can be performed at predefined (test-specific) time intervals.

When the time interval has elapsed, the analyzer issues a recommendation for a QC
measurement. This is indicated by the Calibration and QC Select button on the
System Overview screen highlighted in yellow.
In case an automatic QC sample is on the sample disk, this QC is performed
automatically.
e See Timeout QC on page B-185.
Automatic QC It is possible to keep frequently used controls on the sample disk—ready to be used
any time before or during routine operation. Thus, in combination with Timeout
QC, the analyzer is able to perform QC measurements without any intervention by
the operator.
e See Programming auto QC measurements on page B-209.
QC after calibration For this kind of QC measurements no special settings are needed. QC measurements
are performed for all calibrated tests without explicit requests from the operator,
when the control is activated and on board.
e See To perform QC after calibration on page B-187.
Manual QC This function allows you to measure QCs of any test based on your judgment.
e See Requesting QC measurements on page B-186.
Definitions concerning QC
This section explains some QC expressions that are used in the following:
o Active cobas c packs are currently in use. Sometimes called current reagents. The
opposite are standby cobas c packs.
o Controls or control samples are used synonymously for quality controls (QCs).
Controls are special samples that are used for QC.
Roche Diagnostics
QC concept
Accumulation of QC measurement data
At the end of daily operation, QC measurement data should be accumulated. When

accumulating QC results, the corresponding data are deleted from the QC >
Individual screen and transferred to the QC > Cumulative screen.
Two accumulation methods There are two accumulation methods available: Mean-R and X-R. The choice for one
or the other method is made under Utility > System (Page 1/5) > QC Setting.
o X-R transfers only one QC result from individual QC to cumulative QC.
Therefore you must specify a measurement when accumulating QC data.
o Mean-R calculates cumulative QC data on the basis of all individual QC results
being accumulated.
Two calculation methods If Mean-R is set as accumulation method, two methods are available for the
calculation of mean values and SD values in cumulative QC: DayToDay and Overall.
o The Overall method uses a weighting factor for each accumulated set of data.
o In the DayToDay calculation method all accumulations have the same weight.
The calculation method is selected under Utility > System (Page 1/5) > QC Setting.
Roche Diagnostics
QC concept
Handling of QC results
The following chart shows the handling of QC results starting with the measurement
of QC samples and ending with the deletion of QC results. It shows the different
screens that display QC results, and shows the particular action that moves (deletes,
accumulates) the results from one screen to another screen.
QC measurements
displayed in… displayed in…
performed
Data Review QC Individual

Routine view
Delete Record Accumulate
Delete All
transfer to…
transfer to…
Data Review QC Cumulative

QC view
Delete All Delete Delete

Delete Record
o Deletes QC in QC View
o Deletes QC in QC Individual
o Deletes QC in QC View o Deletes QC in QC View o Deletes QC in QC Cumulative

o Deletes QC in QC Individual o Deletes QC in QC Individual
Recommendation
Workflow for handling QC results in order to keep as little QC data as possible
Data Review QC Individual Data Review QC Cumulative

Routine view QC View
Delete All Accumulate Delete All Delete All
Figure B-88 Workflow for handling QC results
Roche Diagnostics
QC concept
Summary QC View is linked with the QC individual database. If a QC result is deleted in the
QC View database, it is as well deleted in the QC individual database and vice versa.
Therefore it is recommended to first accumulate individual QC results before
deleting QC data on Data Review > QC View.
QC data of the QC cumulative database should only be deleted, if the particular data
is no longer required.
Working in barcode or non-barcode mode
On the Utility > System screen under Barcode Setting, you can verify or change
whether the analyzer uses barcodes for controls or not.
When working with barcodes, controls are automatically identified. In case controls
are processed in non-barcode mode, it is necessary to assign a position for each
control.
The current position assignment is listed on the QC > Control screen. To provide
additional assignments or remove existing assignments choose Position
Assignment.
o For assigned controls (without barcode), be sure to use the specified position. A
misplacement would go undetected by the analyzer and yield invalid results.
o Do not use barcoded and assigned controls on the same QC position.
e For more information see QC Control screen on page B-200.
Roche Diagnostics
QC Status screen
QC Status screen
The following sections explain certain tasks associated with the QC > Status screen
To display this screen choose QC > Status.
Figure B-89 QC > Status screen
The QC > Status screen displays all installed controls with the corresponding
assigned and activated tests.
The test display can be sorted by test name (alphabetical order), control name
(alphabetical order), QC test selection, or QC cause. Tests can be selected with the
Select/Deselect button. Selected tests are highlighted in green. A control test
selection is made for the subsequent control run. The control test selections of the
status list disappear after the control is measured.
Only the test selection of pipetted control tests disappear. If a test is requested but the
control sample is not on board, the QC request remains.
Routine QC Assign The Routine QC Assign button selects all Routine QC tests (active reagents only) for
a control measurement. Routine QC tests are all activated tests for all installed
controls.
Tests that are not to be measured can be deselected on the Status screen: Highlight
the tests on the status list and then use the Deselect button.
Routine QC To display a list of all currently activated Routine QC tests, choose Routine QC.
Stand By Bottle QC Use this button to select cobas c packs for stand by QC.
Roche Diagnostics
QC Status screen
Stability Timer Reset Use this button to reset the On Board Stability Time (set in Utility > Application >
Range). In case the on board stability time of the control is expired (highlighted
yellow in QC > Status plus a yellow alarm message), the timer can be reset with this
button after the control material is exchanged. This function is only available in
Standby or Pause.
Direct access from System From the System Overview screen, select the Calibration and QC Select button and
Overview screen then the Routine QC button in the QC area on the right. This is essentially the same
as selecting the Routine QC Assign button on QC > Status.
Timeout QC
A control interval in hours can be defined for each application on the Range tab on
Utility > Application. Select the Control Interval Time check box and type the
appropriate time in the adjacent text box.
Figure B-90 Range tab on Utility > Application
The analyzer checks the timeout every 30 minutes. When the specified time has
elapsed, a QC request is triggered. This QC request is indicated on the QC > Status
screen by the word Timeout in the Cause column.
Be sure to place an appropriate QC sample on the sample disk in advance if the
control is defined as auto QC.
The control is measured with the active (in use) cobas c pack.
Roche Diagnostics
QC Status screen
Requesting QC measurements
QC measurements can be requested individually for active and standby

cobas c packs. Active cobas c packs are currently in use. Standby cobas c packs are
already on board but not in use at present.
e For more information about requesting QC manually, see:
To perform QC after calibration on page B-187
a To perform controls for active reagents

1 Choose QC > Status.
2 If routine QC is to be performed, choose Routine QC to select all tests that are
currently loaded on the analyzer and activated for QC.
If individual tests are to be selected, go to step 3.
3 Choose the appropriate test and control. Multiple tests and controls can be
highlighted.
4 Choose Select. A green bar appears in the Selection column. Manual is displayed
in the Cause column. The Select button toggles to Deselect.
Choosing Deselect deselects a highlighted item and Deselect toggles to Select.
5 Choose Save to request the selected controls for measurement.

Now, continue with the procedure: To print a QC load list and to load controls on
page B-187.
a To perform controls for standby reagents

1 On QC > Status choose Stand By Bottle QC to display the Stand By Bottle QC
window.
Figure B-91 Stand By Bottle QC window
2 Select the appropriate test and control. Multiple tests and controls can be
highlighted.
Roche Diagnostics
QC Status screen
3 Choose Select to select all highlighted tests and controls. A green bar appears in
the Selection column. The Select button toggles to Deselect.
Choosing Deselect deselects a highlighted control and the Deselect button toggles
to Select.
4 Choose OK to request the selected controls for measurement.

Now, continue with the next procedure: To print a QC load list and to load
controls.
a To print a QC load list and to load controls

1 Choose Print (global button) > QC and select QC Load List.
You can also print a QC load list from System Overview > Calibration and QC
Select. Select the QC option in the Load List area.
2 Choose Print. The analyzer prints a QC load list.
Calibration or QC failure
If you have to manually assign a calibrator or QC container or other sample
CAUTION container—for example, due to an unreadable barcode—do not place any containers
with barcodes in manually assigned positions.
It is possible to do a QC with a mixture of barcoded and non-barcoded QCs. However,
you must assign the position of the non-barcoded QC and no position should be
assigned for the barcoded QC. If you put a barcoded container on a position that was
assigned manually, the QC is not measured.
3 Load the controls onto the sample disk.
If you perform QC after calibration, QC samples do not have to follow directly after
calibrator samples. Other samples can be placed in between them.
a To perform QC after calibration

1 A calibration request automatically triggers a QC request for that cobas c pack
(active and standby cobas c packs). Controls have to be loaded on the sample
disk.
Roche Diagnostics
QC Run Status screen
To display this screen choose QC > Run Status.
Figure B-92 QC > Run Status screen
Use the Run Status screen to get an overview of the last 500 quality control (QC)
measurements performed on the analyzer or to view the most recent QC
measurements for one particular test specified.
Use the Test box to select all tests or one specific test to be displayed on the chart. Use
the scroll bar at the bottom of the chart to move the focus from one result to the next.
QC run status details The Run Status screen consists of a details area in the upper part of the screen and a
run status chart in the center of the screen. The details area displays information that
relates to the QC measurement selected on the run status chart. The chart in the
center of the Run Status screen displays up to 500 results of QC measurements.
Chart background A white background refers to today’s measurements. A blue background refers to
past days’ measurements.
Roche Diagnostics
Chart symbols Shape: Circles are used if QC violation is activated for a test in Utility >
Application > Calib; otherwise triangles are used.
e For more information on QC violation, see QC-triggered calibration (QC Violation) on
page B-152.
Color: Red denotes that a QC result falls outside the confidence limits, and yellow
denotes that it is outside 2 SD limits. Green symbols are used for results within the
relevant limits.
Displayed if QC violation is QC result exceeds confidence limit (right axis of

activated chart). A calibration is automatically
recommended for the affected test.
Displayed if QC violation is QC result within confidence limits
activated
Displayed if QC violation is not QC result falls outside  2 SD (left axis of chart)
activated and confidence limits
are not checked
Displayed if QC violation is not QC result within  2 SD
activated
Special fields in the details area Status: This field displays a reagent’s status of precedence. Possible values are
Current, SB1, SB2, SB3…
Current cobas c pack currently in use, same as active cobas c pack

SB1 (Standby cobas c pack 1): The cobas c pack which will be used after the active
cobas c pack.
SB2 (Standby cobas c pack 2): The cobas c pack which will be used after SB1.
The order of precedence of standby cobas c packs within the same lot is assessed by the
time of registration; the oldest standby cobas c pack is used first.
cl-low / cl-high: These fields display the confidence limits specified for the selected
test. If the selected test is not configured for QC violation but for timeout calibration,
the fields under cl-low and cl-high are blank.
Roche Diagnostics
QC Individual screen
The following sections explain certain tasks associated with the QC > Individual
To display this screen choose QC > Individual.
Figure B-93 QC > Individual screen
The QC > Individual screen lists all non accumulated QC results.

The list can be sorted by test name and control name. The table below explains the
most important columns of the list.
Control Name of the control

Lot No. Lot number of control material
Target Mean Control target mean
Target SD Control target standard deviation
N Number of QC runs carried out on this control since the last
accumulation
Mean Calculated mean of N measurement results
SD Standard deviation calculated from N control measurements
CV [%] Coefficient of variation calculated from the mean value
Result Most recent QC result of this control
To exclude an individual QC point and add a comment on page B-192
Roche Diagnostics
Individual QC Chart window On the QC > Individual screen, choose Chart to open the Individual QC Chart
window.
Figure B-94 Individual QC Chart window
This window displays all non-accumulated QC results of the selected test in a Levey-
Jennings chart. A Levey-Jennings chart provides a visual method of monitoring
trends in QC results. The result values are scaled to the standard deviation (SD) of the
respective test.
Up to three controls can be selected (Select button) and displayed on one chart.
Comment Use the Comment button to comment, exclude, or comment and exclude a single
measurement. The chart uses three special symbols with the following meaning:
A comment is attached to this point (in QC >Individual QC > Chart > Comment).
The point is excluded (in QC >Individual QC > Chart > Comment).
The point is excluded and a comment is attached (in QC >Individual QC > Chart >
Comment).
o Excluded points are removed from statistics but still displayed on the chart. Excluded
points cannot be included later.
o Control values of standby cobas c packs are always excluded.
Roche Diagnostics
Excluding an individual QC point or adding a comment
Individual QC points on a QC chart can be excluded from QC calculations if

required. It is also possible to annotate individual QC points.
a To exclude an individual QC point and add a comment

1 Choose QC > Individual > Chart.
2 Select the QC point to be excluded from QC calculations.
3 Choose Comment on the Individual QC Chart window to display the Comment
window.
4 If necessary type a comment in the Comment box.
5 Choose Exclude. The window is closed after confirmation.
6 Choose OK.
Roche Diagnostics
Configuring and using realtime QC
In realtime QC the analyzer uses the Westgard algorithm to evaluate QC

measurements. The Westgard algorithm is based on a multi-rule Shewhart-type
method and applies a set of rules to each QC. These rules are selected in QC >
Individual > Realtime QC > Select Rules for each test.
Quality control by the Shewhart The instrument measures two controls (X and Y) in pairs, whose mean value ( X ) and
method standard deviation (SD) are known for each test. Each QC result is processed
according to the judgment standard (multi-rule) and it is judged whether it can be
reported or not.—When the algorithm yields an error, an alarm is generated
indicating whether the error is a random error, a QC error, or a systematic error.
The kinds of realtime QC samples are 100 at a maximum. The following figure shows
an illustration of the multi-rule chart. The abbreviations used in this figure are
described in Table B-31 on page B-194.
Control values X and Y
No
1-2SD Inside control range
Yes
No
No No No No No No No No
1-2.5SD 1-3SD 2-2SA R-4SD 2-2SW 4-1SA 4-1SW 10XA 10XW
Yes Yes Yes Yes Yes Yes Yes Yes Yes
Outside control range (error message)
Figure B-95 Application of multi-rule Shewhart-type method in realtime QC
Configuration of realtime QC Configure realtime QC in Realtime QC window (QC > Individual > Realtime QC):
Choose Select to specify control (X) and control (Y) for each relevant test. Then,
choose Rules to select the rules.
Only QC results of active reagents are evaluated.
e For more details see Configuring realtime QC on page B-196.
The following table briefly explains all rules that are selectable for realtime QC and
lists the corresponding alarms.
e For more details, refer to the COBI CD.
Roche Diagnostics
Rule Order Judgement Judgment area Alarm

1-2SD 1 Either X or Y data 1-2SD None
Y
value is above +2SD
or below -2SD. 2SD
X
1-2.5SD 2 Either X or Y data 1-2.5SD Q2.5SD

Y
value is above +2.5SD
or below -2.5SD. 2.5SD
1-3SD 3 Either X or Y data 1-3SD Q3SD

Y
value is above +3SD
3SD
or below -3SD.
X
2-2SD 4 Both of X and Y data 2-2SA S2-2Sa

Y
values are above
3SD
+2SD or below -2SD. 2SD
X
6 The last two X or Y 2-2SW S2-2Sw

Y
data values are above
-2SD
2SD
+2SD or below -2SD.

2SD
X
-2SD
R-4SD 5 One of X and Y data R-4SD R-4SD

Y
value is above +2SD
3SD
and the other is below 2SD
-2SD. X
Table B-31 QC evaluation by Shewhart multi-rule method and corresponding alarms (Sheet
1 of 2)
Roche Diagnostics
Rule Order Judgement Judgment area Alarm

4-1SD 7 The last two X and Y 4-1SA S4-1Sa
Y
+1SD or below -1SD.
(Total 4 values) 1SD
X
-1SD
8 The last four X or Y 4-1SW S4-1Sw
Y
-1SD
1SD
+1SD or below -1SD.
1SD
X
-1SD
10X 9 The last five X and Y 10XA S10Xa

Y
data values fall on the
+ or - side of the
mean value. (Total X
10 values)
10 The last ten X or Y 10XW S10Xw

Y
data values fall on the
+ or - side of the
mean value. X
Table B-31 QC evaluation by Shewhart multi-rule method and corresponding alarms (Sheet
2 of 2)
Deselecting realtime QC In cases where quality control using one QC sample is conducted instead of realtime
QC, specify None for X and Y corresponding to each analytical item and enter 0 for
SD. If in QC > Install the SD value is 0, a realtime QC check is not performed.
Roche Diagnostics
Configuring realtime QC
Choose QC > Individual > Realtime QC to display the Realtime QC window.
Figure B-96 Realtime QC window
This window shows a diagram with the QC results for a selected test and a selected
pair of controls. The diagram is scaled to the target SD of control (X) and control (Y),
respectively. The newest QC result is shown in red.
Select Choose this button to assign two controls—control (X) and control (Y)— to be
evaluated by the multi-rule method.
Roche Diagnostics
Rules Choose this button to select rules used to evaluate the QC results. A pair of controls is
compared against a known standard deviation (SD) and mean. If one or both of the
controls fail a rule, the analyzer continues applying the testing criteria for all selected
rules. When at least one rule violation is found, the corresponding data alarm is
issued.
Figure B-97 Select Rules window
The following symbols are used in the realtime QC plot:
Normal: Without QC errors
Random: Random QC errors
System: System QC errors
With intermediate QC errors
Reject Choose this button to reject realtime QC results that have specific data alarms
attached. Affected result points are removed from the plot.
Roche Diagnostics
Accumulation of QC results
At the end of daily operation, QC measurement data should be accumulated. There

are two accumulation methods available: Mean-R and X-R. The choice for one or the
other method is made under Utility > System (Page 1/5) > QC Setting.
e For an explanation of the two accumulation methods, see
Accumulation of QC measurement data on page B-181.
System settings for QC accumulation

Choose Utility > System (Page 1/5) > QC Setting to display the QC Setting window.
Figure B-98 Utility > System (Page 1/5) > QC Setting window
Accumulation Method Select one of the two accumulation methods, Mean-R or X-R, from this box.
e See Accumulation of QC measurement data on page B-181.
QC Calculation If the accumulation method is Mean-R, select one of the two calculation methods,
DayToDay or Overall, from this box to specify how mean and SD values are
calculated in the cumulative QC.
This box is not available if X-R is selected in the Accumulation Method box.
Accumulating QC results
a To accumulate QC data
1 Select the data to be accumulated from the list on the QC > Individual screen.
2 Choose Accumulate.
3 If Mean-R is set as accumulation method, go to step 4.
If X-R is set as accumulation method, type the consecutive number of the QC
results to be used for the accumulation in the box or type 0 (zero) to transfer the
mean value; then choose OK.
4 In the confirmation window choose OK to accumulate the selected data.
After accumulation the corresponding data are deleted from the QC > Individual
screen and a new standard deviation (SD) and mean value is calculated and
displayed on QC > Cumulative.
Roche Diagnostics
QC Cumulative screen
QC Cumulative screen
To display this screen choose QC > Cumulative.
Figure B-99 QC > Cumulative screen
The QC > Cumulative screen lists all accumulated QC results.

The list can be sorted by test name and control name. The table below explains
columns whose meaning is different from that on the QC > Individual screen:
N Number of accumulations (max. 500)

Mean Accumulated mean for each test (using the accumulation method
selected on Utility > System > QC Setting)
Roche Diagnostics
QC Control screen
QC Control screen
The QC > Control screen provides an overview of all controls that are downloaded
and assigned to a position on the sample disk.
When working with barcodes, controls are automatically identified. In case controls
are processed in non-barcode mode, it is necessary to assign a disk position number
for each control. The current position assignment is listed on the QC > Control
screen.
Choose QC > Control to display this screen.
Figure B-100 QC > Control screen
To provide additional assignments or remove existing assignments follow the

procedure below.
Roche Diagnostics
QC Control screen
a To assign a control to a specific position

1 On QC > Control choose Position Assignment.
Figure B-101 QC > Control > Position Assignment window
2 On the Position Assignment window select the control from the list on the left
and an unassigned disk position from the list on the right.
3 Choose Assign to register the new assignment.
4 To remove an existing assignment select the concerned disk position from the list
on the right and choose Remove.
5 Choose OK to save the changes and close the window.
Roche Diagnostics
QC Install screen
QC Install screen
The following sections explain certain tasks associated with the QC > Install screen
To display this screen choose QC > Install.
Figure B-102 QC > Install screen
Use this screen to add and delete controls from the analyzer and to assign control
values.
The list on the left of the screen displays all controls that are installed on the analyzer.
For all installed controls the control name is highlighted in green. Up to a 100
controls can be installed on the analyzer.
Editing control values on page B-206
Activating control tests on page B-208
Roche Diagnostics
QC Install screen
Loading control data
Control data for all available applications can be downloaded to the analyzer from
cobas link. An operator ID of supervisor level or higher is required for this operation.
This operation is a part of the installation process for a new application.
e For an overview of the complete installation process of a new application, see:
Loading or updating applications on page B-214
o In case controls are used without barcodes, assign the control positions manually.
o Controls may be added to the analyzer but the control tests will not run until they are
activated on the QC > Install screen.
a To download control data from cobas link

1 Choose QC > Install > Download to open the Download window.
Figure B-103 Download window for control data
2 Select one of the available search options (Required Item, Control Name, Lot
Number, or Release Date).
o Lot Number is the recommended search condition.
o The Lot Number must always be entered with 8 digits. The last two digits are
zeros (XXXXXX00).
o The option Release Date refers to the date when the calibrator was released by
Roche Diagnostics.
Roche Diagnostics
QC Install screen
displayed.
In the column Note you can find additional information about the control such as
reason for change.

All necessary information (such as applications covered by the control, target
mean values, and target SD values) is automatically stored on the analyzer.
7 To run control tests with a newly installed control it is necessary to activate these
tests: Select the tests from the list on the right in the QC > Install screen and
choose Activate Test. The test name is highlighted in green when a test is
activated.
e See Activating control tests on page B-208.
If necessary it is possible to edit the downloaded target values and/or confidence

limits.
e See Editing control values on page B-206.
Roche Diagnostics
QC Install screen
a To add controls manually (without cobas link)

1 Select a blank row in the control list on the QC > Install screen.
2 Choose Add.
3 Type all necessary data in the Add Control window.
The Material Code range is from 801-999.
Figure B-106 Add Control window
4 Choose OK. The new control appears on the control list.

To run control tests with the newly installed control it is necessary to manually
enter the target values for each test and then to activate these tests.
5 Choose Edit to enter target mean and target SD. If necessary, enter the confidence
limits.
Then choose Activate Test to activate the tests for the new control.
e For more details see:
Activating control tests on page B-208
Roche Diagnostics
QC Install screen
Editing control values
Control values can be edited on the QC > Install screen. You can use this function,
for example, if an Important Note concerning reassigned target values for a particular
lot of controls is released. Instead of downloading the control values from cobas link
you may also edit them manually.
a To edit control values

1 On the QC > Install screen choose the name of the control to be edited in the
Control list on the left side of the screen.
2 Choose Edit to display the Edit Control window.
Figure B-107 Edit Control window
3 Select the test to be edited from the list.

4 Type the new target mean and SD (standard deviation) values, cumulative and
individual, in the appropriate text boxes on the right side of the screen.
If the test uses this control for its QC Violation assessment, the Calculate button
is active; if not, go to step 6.
e For more information on QC violation, see
QC-triggered calibration (QC Violation) on page B-152.
5 Choose Calculate to recalculate the confidence limits on the basis of the edited
target and SD values and the QC violation rule (set under Utility > Application >
Calib.).
In case target and SD values are edited or entered manually, the calculation of
confidence limits is achieved by choosing the Calculate button. However, the
confidence limits can also be typed directly into the text boxes under Confidence
Limit.
The Calculate button and the boxes High and Low are not available if the selected
test is not configured for QC Violation.
Roche Diagnostics
QC Install screen
6 Choose Update to update the window.

7 Repeat steps 3 to 6 for all tests assigned to this control that need to be edited.
8 Choose OK to save the changes and close the Edit Control window.
Incorrect results due to wrong control values

If you manually edit control values, you must ensure that the QC results are correct.
CAUTION Perform QC measurements before you resume routine operation.
9 Perform QC measurements for all tests assigned to the edited control.
No update of manually edited control values

In case a value has been manually edited, this value will not be updated when you
download new control values from cobas link.
If you want to return to the original control value, delete this control data and download it
again from cobas link. Perform QC measurements before you resume routine operation.
Reassignment of control values
If target values for a particular control have been reassigned, you are informed by
means of the cobas e-library (Value Sheets or Important Notes). In this case you have
to reassign the control values on the cobas c 311 analyzer.
Control values are not updated by download

When downloading reassigned control values from cobas link, the cobas c 311 analyzer
will not overwrite the existing values. The values will not be updated for this particular lot.
To update control values you must reassign the control values manually.
e For reassign control values, see To reassign control values manually on page B-207
a To reassign control values manually

1 Enter the control values for a controls that must be reassigned on the Edit
Control window.
e See Editing control values on page B-206
Roche Diagnostics
QC Install screen
Activating control tests
Tests can only be activated when the analyzer is in Standby.
a To activate control tests

1 On the QC > Install screen choose the appropriate control name in the list box on
the left side of the screen.
2 Choose the test to be activated in the list on the right of the screen.
3 Choose Activate Test. The test name is highlighted in green when the test is
activated.
4 Repeat step 2 and 3 for all tests to be activated for that control.
To activate a test the test must have target and SD values entered for the
control.
e See Editing control values on page B-206.
Roche Diagnostics
Programming auto QC measurements
When a control interval time is specified on Utility > Application > Range for an
application, it is possible to let the analyzer automatically perform necessary QC
measurements with controls that permanently reside in the sample disk.
At intervals of 30 minutes, the instrument checks whether a preset time is exceeded
or not. If a time period after the last QC measurement exceeds the preset time, the
instrument issues a recommendation of execution of QC measurement.
In case an automatic QC selection was made and quality control samples are on the
sample disk, the instrument will carry out automatic QC measurement by
intervening the current measurement of routine samples.
An on board stability time of QC samples on the instrument can be set for each test.
An alarm will be issued if the on board stability time of QC samples is exceeded.
a To program auto QC measurements

1 Choose Utility > Application > Range.
2 Select the Control Interval Time check box for the relevant tests and specify a
control interval from 1 to 1000 hours.
3 Select the On Board Stability Time check box and specify an on board stability
time for the QC sample from 1 to 99 hours.
4 Choose QC > Install.
5 Select a quality control sample to be subjected to automatic QC measurement.
The selected quality control sample is highlighted.
6 Choose Select Auto QC. The asterisk mark (*) is indicated at the upper left of the
control number concerned.
Roche Diagnostics
Roche Diagnostics
cobas c 311 analyzer 11 Configuration
Table of contents
Configuration
This chapter describes the configuration of the cobas c 311 analyzer for customers.

Application ................................................................................................................... B-213
Overview ................................................................................................................ B-213
Loading or updating applications ....................................................................... B-214
Loading application parameters ................................................................... B-215
Loading the HbA1c Whole blood application .................................................. B-217
Overview .......................................................................................................... B-217
Installing and configuring the HbA1c application .................................... B-219
Notes for the use of the application ............................................................. B-220
Description of application parameters .............................................................. B-221
Description of application parameters - Analyze tab ...................................... B-222
Description of application parameters - Calib. tab .......................................... B-224
Auto masking .................................................................................................. B-225
Auto Calibration ............................................................................................. B-225
Description of application parameters - Range tab ......................................... B-227
Unit of measure ............................................................................................... B-228
Report name .................................................................................................... B-229
Automatic Rerun ............................................................................................ B-229
Technical limit (photometric tests) .............................................................. B-229
Repeat limit ...................................................................................................... B-230
Qualitative fields (photometric tests) .......................................................... B-231
L, H, I fields (serum index check) ................................................................ B-231
Expected values ............................................................................................... B-232
Description of application parameters - Others tab for ISE tests .................. B-233
Setting up individual calibration curves for each ISE sample type .......... B-234
Roche Diagnostics
11 Configuration cobas c 311 analyzer
Table of contents
System configuration .................................................................................................. B-235

Programming system parameters ....................................................................... B-236
Using patient IDs .................................................................................................. B-238
Using SBS mode (scan before sample stop) ...................................................... B-239
Generating multiple results for a single test ...................................................... B-240
Host Communication settings ............................................................................ B-241
Communication Setting tab .......................................................................... B-241
Text Setting tab ............................................................................................... B-242
Result Upload Setting tab .............................................................................. B-242
Assigning tests or profiles to test keys ................................................................ B-243
Maintenance / Pipe Setting / Power Up Pipe buttons ..................................... B-245
Sample Disk Setting button ................................................................................. B-245
Using false bottom tubes ...................................................................................... B-246
Module Set ................................................................................................................... B-247
Assigning a test ...................................................................................................... B-248
Calculated Tests ........................................................................................................... B-249
Programming calculated tests ............................................................................. B-250
Programming compensated tests ....................................................................... B-253
Special Wash ................................................................................................................ B-255
Programming a reagent probe wash .................................................................. B-255
Programming a cell wash ..................................................................................... B-257
Programming a sample probe wash ................................................................... B-258
Report Format ............................................................................................................. B-261
Customizing patient report format .................................................................... B-261
Comparison of data monitor format and report format ................................. B-264
Data Print report (monitor format) ............................................................. B-264
Data Print report (report format) ................................................................. B-264
Saving system parameters .......................................................................................... B-265
Restoring system parameters ..................................................................................... B-267
Roche Diagnostics
Application
Application
When the system was installed by your Roche Service representatives all required
applications are installed. This section explains how to add new applications and
configure specific application parameters.
Overview
General information Up to 100 tests (86 photometric tests, 3 electrolyte tests, 8 calculated tests, and
3 serum indices) can be installed on the analyzer.
The following test numbers are fixed:
Test number Test name

87 Na
88 K
89 Cl
90 Serum index L
91 Serum index H
92 Serum index I
Table B-32 Fixed test numbers
Loading a new application Before you can load a cobas c pack of a new application onto the analyzer, the
application parameters have to be downloaded from cobas link. Otherwise, the
cobas c pack will be rejected by the system.
e Refer to the following sections to get information about:
cobas link on page A-31
Description of application parameters on page B-221
A description for loading Development Channel applications is available on cobas link.

Refer to the Instructions for Use for the cobas c pack MULTI. Please contact your Roche
representative for more information.
Roche Diagnostics
Application
Loading or updating applications
The cobas c 311 analyzer requires application parameters, calibrator data, and
control data for each application. All data required for a new application can be
downloaded from cobas link. Existing applications can be updated via cobas link.
Installation Guide To be able to use a new application on the analyzer, you have to perform the
following steps:
1. Load the application parameters from cobas link. Customize the default
parameters if necessary.
Description of application parameters on page B-221
2. Load the calibrator data from cobas link. Or: Check and/or edit the number of
decimal places for Std (1) manually.
e See Loading calibrator data on page B-167
3. Load and activate the control data for the new application.
e See Loading control data on page B-203.
4. Assign sample disk positions for calibrators and controls (only necessary when
working with non-barcoded calibrators or controls).
To assign a calibrator to a specific position on page B-175
To assign a calibrator to a specific position on page B-175
To assign a control to a specific position on page B-201
5. Add special washes if applicable.
e See Special Wash on page B-255
6. Load the cobas c pack(s) onto the analyzer.
e See Loading cobas c packs on page B-55
7. Define a key setting for the new application.
e See To assign a test or a profile to a key on page B-244.
8. Define reagent level check alarms if necessary. Choose Utility > System
(Page 2/5) > Reagent Level Check.
e For more information, please refer to the Online Help for that particular window.
Roche Diagnostics
Application
Loading application parameters

The following procedure describes how you can download new or update existing
application parameters from cobas link. It can be performed by an operator with
administrator level password only.
a To download application parameters from cobas link

1 Choose Utility > Application > Download to open the Download window.
Figure B-108 Download window for application parameters
2 Select one of the available search options (Required Item, Application Code,
Application Name, Cassette No., or Release Date).
o Application Code: Select the application code (ACN) from the list box.
The application code number (ACN) is available in the instructions for use of
the corresponding cobas c pack. Up to four applications (ACN) per
cobas c pack are possible.
The Application Code is the recommended search condition.
o Application Name: Select the application name from the list box.
o Cassette No.: Enter the Cassette number in the text box.
Cassette No., catalogue number, system-ID

Various terms for Cassette No. are used:
o Cassette No. on the Download window
o Catalogue number on cobas link
o System-ID on cobas c packs
Roche Diagnostics
Application
displayed.
In the column Note you can find additional information about the application
such as reason for change.
If the required item is not contained in the list, you can go to the next page by clicking
on the page number (e.g., 1/2) in the upper right corner of the list.
The short test name assigned to the application automatically displays in the Test
Name box. However, it is possible to assign a different test name if needed.
It is also possible to change the channel number. This may be needed to change
the pipetting sequence.
Roche Diagnostics
Application

7 Choose OK to read all parameter information.
The application parameters of the downloaded application are displayed on the
Application screen. Some parameters are user-definable.
e See Description of application parameters on page B-221.
Loading the HbA1c Whole blood application
This section describes the necessary steps to utilize HbA1c whole blood application
on the system.
Information on the general installation procedure for a new application is given in
the previous section.
e See Loading or updating applications on page B-214
Overview
Necessary applications To obtain results for HbA1c (%), the following applications are necessary:
Application/Reagent Short name Application code (ACN)

Hemolyzing Reagent A1CD2 952
Hemoglobin Hb-W3 871
Hemoglobin A1c A1-W3 881
% Ratio of Hemoglobin/Hemoglobin A1c RWI3 891
Table B-33 Applications and reagents of the HbA1c (%) application
Two cassettes are necessary for the HbA1c test. One cobas c pack contains the
hemolyzing reagent (application code number 952). The application code numbers
871 and 881 refer to the second cobas c pack which contains reagent for both
applications (Hb-W3 and A1-W3).
Roche Diagnostics
Application
Reaction course The following figure shows the reaction course of the application:
1 Sample pipetting 2 Hemolyzing process 3 Hemoglobin analysis 4 Hemoglobin A1c analysis

For pipetting EDTA whole blood EDTA whole blood sample is Hemolyzed (prediluted) sample R3 (A1-W3 reagent) is added.
sample, the sample probe lowers pipetted into predilution cuvette and R1 (Hb-W3 reagent) is o 2 Point assay
down to 70% of the filling volume. and is hemolyzed with pipetted. o Cycle 24-57
hemolyzing reagent (A1CD2). o 1 Point assay
o Cycle 1-23
EDTA whole blood A1CD2 reagent Hb-W3 reagent A1-W3 reagent
70%
Reaction cuvette Reaction cuvette

30%
Predilution cuvette
Cycle (time)
0 6 23 57
Hemoglobin analysis Hemoglobin A1c analysis

Absorbance
o Sample (prediluted) + o R3 (A1-W3 reagent) is added

R1 (Hb-W3 reagent)
R3
S, R1
0 34 Cycle (time) 70
Figure B-111 Reaction course of the HbA1c application
Result calculation The result for the Hemoglobin A1c analysis is calculated according to IFCC
standardization:
A1-W3 HbA1c
Equation B-1 RWI3 = -----------------  100% (that means HbA1c % = ------------------  100% )
HB-W3 Hb
This calculated test can be downloaded as application RWI3 (Application code 891)
Roche Diagnostics
Application
Installing and configuring the HbA1c application

To be able to utilize the HbA1c application on the system and to obtain results
according to IFCC reporting range, you have to perform the following installation
procedure:
a To install and configure the HbA1c application

1 Download application parameters for the following applications:
o Hemoglobin (Hb-W3, ACN 871)
o Hemoglobin A1c (A1-W3, ACN 881)
o % Ratio of Hemoglobin/Hemoglobin A1c (RWI3, ACN 891)
o Hemolyzing Reagent (A1CD2, ACN 952)
2 Download calibrator data for the following calibrator:

o C.f.a.s HbA1c (674)
Loading calibrator data on page B-167
3 Download control data for the following controls:

o HbA1c Control N (357), or PreciControls HbA1c Norm.
o HbA1c Control P (358), or PreciControls HbA1c Path.
4 Update the control values to the IFCC reporting range values.

These values can be obtained from the control value sheets.
5 Program a calculated test for the HbA1c values according to Protocol 1 (IFCC).
Use following settings:
o Sample Type: Suprnt
o Unit of Measure: mM/M
o Report Name: HbA1c Gen.3 IFCC
o Item: RWI3
o Formula: (A1-W3 / HB-W3)*1000
Programming calculated tests on page B-250
6 Set the decimal places of the calculated test RWI3:

Roche Diagnostics recommends reporting the results with one decimal place.
To set range parameters on page B-251
7 Assign the RWI3 test to a module.

Module Set on page B-247
Assigning a test on page B-248
Roche Diagnostics
Application
8 Assign the RWI3 test to a key on the Suprnt tab of the Key Setting window.
To assign a test or a profile to a key on page B-244
9 Load cassettes for the following applications:

o A1C-2: Hemoglobin (Hb-W3, ACN 871)/Hemoglobin A1c (A1-W3, ACN
881)
o A1CD3: Hemolyzing Reagent (A1CD2, ACN 952)
To load a cobas c pack on page B-55
10 Calibrate the following test and perform QC measurements:

o Hb-W3
o A1-W3
Notes for the use of the application
Result calculation according to Roche Diagnostics provides the application RWI3 (Application code 891) to calculate
DCCT/NGSP reporting range the Hemoglobin A1c% results according to DCCT/NGSP reporting range.
A1-W3
Equation B-2 RWD3 = -----------------  91.5 % + 2.15
HB-W3
To report the results according to IFCC reporting range, you have to configure the
calculated test ACN 891 (Formula tab of the Calculated Test Formula window):
A1-W3
Equation B-3 RWD3 = -----------------  1000
HB-W3
Downloading control data for Control data for HbA1c Control N (357) and HbA1c Control P (358), or
IFCC reporting range PreciControls Hba1c Norm/Path are downloaded with values for the DCCT/NGSP
reporting range. The control data must be manually updated to the IFCC reporting
range values. These values can be obtained from the control value sheets.
e See Editing control values on page B-206
Sample container, sample For processing the HBA1c whole blood application only standard tubes with the
pipetting following specifications can be used:
o 13 mm x 75 mm
o 13 mm x 100 mm
o 16 mm x 75 mm
o 16 mm x 100 mm
For HbA1c whole blood QC measurements, sample cups directly placed on a sample
disk can be used.
For the use of blood collection systems as sample tubes, please contact your technical
support.
Clot detection Clot detection is automatically deactivated when pipetting whole blood samples.
Roche Diagnostics
Application
Description of application parameters
It is possible to change some of the default parameters installed with an application to

suit individual laboratory practice. These procedures can be performed by an
operator with administrator level password only.
Incorrect results due to modifying application parameters

Changing any application settings may affect the validity of results.
CAUTION Check the new settings before using it.
e For instructions on changing default application parameters on the Calib. tab, see:
To define calibration timeouts on page B-226
To define application auto masking on page B-225
e For instructions on changing default application parameters on the Range tab, see:
To change the unit of measure for an application after calibration on page B-228
To define application report name on page B-229
e To change the technical limit on page B-230
To change the repeat limit on page B-230
To change qualitative fields (photometric tests) on page B-231
To change expected values on page B-232
To change default settings on page B-233
Roche Diagnostics
Application
Description of application parameters - Analyze tab
The following sections explain certain settings associated with the Analyze tab on
Utility > Application screen. Not all settings are described, but the most important
ones.
To display this screen, choose Utility > Application > Analyze.
Figure B-112 Analyze tab on Utility > Application screen (photometric tests)
Roche Diagnostics
Application
Sample Volume area It is possible to perform automatic dilution on patient samples. Usually the first run is
performed with the normal sample volume settings.
The dilution settings are displayed as follows:
A B C
Photometric test
A Sample volume [L] (undiluted)
B Volume of the diluted sample [L]
C Diluent volume [L]
Figure B-113 Sample Volume area
Example for normal sample volume (Magnesium (MG) test):

o 2.0 L
A rerun is performed with decreased or increased volume settings. If a >Test Flag
appears (technical limit high) the decrease sample volume settings is used for
automatic rerun.
Example for decreased sample volume (Magnesium (MG) test):
o 15 L - Sample volume of the undiluted sample
o 135 L - Diluent volume
o 10 L - Sample volume of the prediluted sample
The sample volume of 15 L is diluted with 135 L diluent (0.9% NaCl) and
afterwards 10 L of the diluted sample is taken for rerun.
If a dilution is selected on the Workplace > Test Selection screen, it takes priority.
Roche Diagnostics
Application
Description of application parameters - Calib. tab
The following sections explain certain settings associated with the Calib. tab on
ones.
To display this screen, choose Utility > Application > Calib.
Figure B-114 Calib. tab on Utility > Application screen (Photometric test)
Figure B-115 Calib. tab on Utility > Application screen (ISE test)
e For instructions on changing default application parameters on the Calib. tab, see:
To define application auto masking on page B-225
Roche Diagnostics
Application
Auto masking
If Auto Masking is selected, the particular test requiring calibration due to a failed
calibration will be masked automatically.
a To define application auto masking

1 Choose Utility > Application > Calib.
2 Select the test to be edited from the Test list on the left.
3 Select the Auto Masking check box to select the test for auto masking.
4 Repeat steps 2 and 3 for all necessary tests.
To activate the auto masking function, select the Auto Masking check box on Utility >
System (Page 2/5) > Calib Mask Setting.
Auto Calibration
Calibration can be requested automatically in the following cases:
o Changeover (Cassette or lot change): If a new cobas c pack or a new reagent lot is
loaded on the analyzer.
o Timeout: If the calibration time period for a cobas c pack or the reagent lot has
expired.
o QC Violation: If a QC result falls outside the confidence limit.
When you load a new application onto the system, the changeover- and time-
triggered calibration is activated by default. If you intend to work with QC-triggered
calibration, you must configure the QC violation parameters and activate QC-
triggered calibration (QC Violation).
To activate QC violation on page B-225
a To activate QC violation
1 On the Calib. tab of the Utility > Application screen select the test to be edited
from the Test list on the left.
2 Select QC Violation.
3 Select the calibration update method (Blank, Span, 2 Point, or Full) from the
Method list box.
e For more information about calibration methods, see:
Calibration concept on page B-151
Roche Diagnostics
Application
4 Select the rule for checking the QC measurement from the Rule list box.
Calibration will be recommended if a QC result falls out of the specified range
(expressed in multiples of one standard deviation).
5 Select the controls that should trigger a calibration.
Up to three controls can be assigned. If any of the QC results falls out of the
specified range, a new calibration is recommended.
For each of the assigned controls, an individual confidence interval must be
specified. The confidence interval can be calculated automatically using the
standard deviation selected in the Rule field or it can be entered manually.
e For more information, see Editing control values on page B-206.
Important notes for QC violation:

o At least one control must be selected for Control 1, 2, or 3.
o If a control is deleted, the setting will be changed to None automatically.
o Make sure that at least one control selection for QC violation is other than None.
Otherwise the QC violation function keeps activated if the corresponding radio button
is selected but can not be carried out.
e For more information about calibration, see:

Triggers for automatic calibration requests on page B-152
Calibration rules for the photometric unit on page B-154.
a To define calibration timeouts

1 On the Calib. tab of the Utility > Application screen select the test to be edited
2 Select Timeout.
3 Define the required calibration method and the timeout period:
o For photometric applications:
O Select the calibration method for lot calibration from the corresponding
list box.
O Type the required timeout period for lot calibration in the corresponding
text box and select the time unit from the corresponding list box.
O Repeat the last two steps for cassette calibration.
o For ISE applications:
O Select the calibration method from the corresponding list box.
O Type the required timeout period for ISE calibration, in days, in the
corresponding text box.
Roche Diagnostics
Application
Description of application parameters - Range tab
The following sections explain certain settings associated with the Range tab on
ones.
To display this screen, choose Utility > Application > Range.
Figure B-116 Range tab on Utility > Application screen (Photometric test)
Figure B-117 Range tab on Utility > Application screen (ISE test)
e For instructions on changing default application parameters on the Range tab, see:
To change the unit of measure for an application after calibration on page B-228
To define application report name on page B-229
To define application automatic rerun on page B-229
To change the technical limit on page B-230
To change the repeat limit on page B-230
To change qualitative fields (photometric tests) on page B-231
To define serum indices on page B-231
To change expected values on page B-232
To change default settings on page B-233
Roche Diagnostics
Application
Unit of measure
The current unit of measure is displayed in this field. The unit has first been selected
when the application was downloaded from cobas link.
Changing the unit also recalculates the concentration based application data, for
example, repeat limit, expected value. The list box can offer up to four different units.
a To change the unit of measure for an application after calibration
Incorrect calibration and QC results

You can change the unit of measurement after an application has been installed. You can
WARNING only change the unit once after the test in question has been calibrated. We strongly
recommend deleting that test application and then reinstalling it.
After changing the unit of measurement, always recalibrate and run controls in order to
ensure no false results are reported.
1 Backup the database and delete patient data (System Overview > Sample Data
Clear > Backup and Clear).
If Sample data clear is executed, all the records of the samples are deleted and QC
data are moved to the QC View.
e For details see
Sample Data Clear button on page B-50.
2 Unload all the cobas c packs for that test (Reagent > Setting > Unloading).
e For details see Unloading cobas c packs on page B-57.
3 Delete the test application (Utility > Application > Delete).

4 Reinstall the test application (Utility > Application > Download).
e For details see Loading or updating applications on page B-214.
5 Change the unit of measure (Utility > Application > Range).

6 Load new cobas c packs.
e For details see Loading cobas c packs on page B-55.
Any cobas c packs for this test that were already in use on the analyzer cannot be
reloaded onto the analyzer after the test has been deleted.
7 Install the calibrator values for this test under Calibration > Install > Download.
e For details see Loading calibrator data on page B-167.
8 Install the control values for this test under QC > Install > Download.
e For details see Loading control data on page B-203.
9 Calibrate the test and perform control measurements.

e For details see Requesting calibration and QC and printing load lists on page B-59.
Roche Diagnostics
Application
Report name
If specified, the report name will be used for printouts instead of the short test name.
For the example in Figure B-116 on page B-227, Test02 will be printed out for
SGLUC reports.
a To define application report name

1 On the Range tab of the Utility > Application screen select the test to be edited
2 Type the desired report name for the test in the Report Name text box.
Automatic Rerun
a To define application automatic rerun

2 Select Automatic Rerun.

Processing reruns on page B-95
Rerun list on page D-47
o If automatic rerun is selected, the sample has to remain on the sample disk until the
results of the sample are available.
o To perform automatic reruns, the automatic rerun function must be selected (Start
(global button) > Automatic Rerun).
Technical limit (photometric tests)

A lower and upper technical limit is set for each application. Recommended values
are transferred via cobas link for photometric tests.
For photometric tests: Any result below the lower technical limit (<Test data alarm) is
repeated with increased volume. Any result over the upper technical limit (>Test data
alarm) is repeated with decreased volume.
For ISE results which are below the technical limit (<Test data alarm), an automatic
rerun is performed with the same sample volume 9.7 L. When the result is above the
upper technical limit (>Test data alarm), the rerun is also done with the same sample
volume as for the first run. Only ISE results for urine samples can be rerun-ed with
decreased sample volume (6.5 L), but this can only be requested manually.
Roche Diagnostics
Application
a To change the technical limit

2 In the first Technical Limit box, type the lower limit.
In the second box, type the upper limit.
Repeat limit
For each test a clinical relevant range can be typed in here. If the test result is outside
this limit but inside the Technical Limit of the application, the test is repeated using
the same sample volume and dilution as in the first run.
a To change the repeat limit

2 In the first Repeat Limit box, type the lower limit of the range.
In the second box, type the upper limit of the range.
o The concentration range of the Repeat Limit must lie within the Technical Limit.
o A Repeat Limit Flag (>Rept / < Rept) is only added to a result if this is enabled in
Utility > System (Page 1/5) > Alarm.
4 Choose Alarm on the Utility > System (Page 1/5) screen.
Figure B-118 Alarm Setting window
5 Verify the settings of the Repeat Limit Flag and the With Automatic Rerun
check boxes. If both are selected, an automatic rerun will be performed if the
result is outside the repeat limit (>Rept, <Rept data alarms).

Processing reruns on page B-95.
Roche Diagnostics
Application
Qualitative fields (photometric tests)

This function is important for DAT (Drugs of Abuse Testing) especially. Qualitative
reporting can be chosen instead of quantitative reporting for each photometric test.
In the text boxes of the first column (1-5) the upper limit concentration range has to
be entered. Any result less than or equal to the value defined here will be printed with
the text defined in the second box.
If a result is higher than range (5) the text defined in text box (6) is taken.
a To change qualitative fields (photometric tests)

2 Select the Qualitative check box to activate the qualitative fields.
3 Type the correct information in the first qualitative text box for (1).
4 Type the symbol that will be printed on the report in the second text box for (1).
5 Repeat steps 3 to 4 for numbers (2) to (6).
L, H, I fields (serum index check)

The serum index reference values can be defined individually for each photometric
and ISE test. In the serum index fields L (lipemic), H (hemolytic), I (icteric) the
ranges that are loaded with the application are displayed.
Limits for H, I and L index are implemented in conventional units in all application
settings. When using international units for H, I and L index the respective serum
index limits have to be changed in all applications.
If at least one serum index field has a value other than 0, serum indexes are checked.
If 0 is entered, the corresponding serum index interference check is not performed.
a To define serum indices

2 Select the text box of the corresponding serum index L, H, or I.
3 Enter the recommended values from the instructions for use of the corresponding
test.
Remember to enter the values in the same unit as those used for the test results
(conventional units or international units).
To use the serum index function, the serum index application must be installed and the
serum index requested on the Workplace > Test Selection screen.
e For more information on serum indices:

refer to the Online Help of the Range tab of the Utility > Application screen or
refer to the COBI CD.
Roche Diagnostics
Application
Expected values
Expected values area is used to define the normal range for men and women in three
different age groups. If the result for this test falls outside the ranges entered here, the
system issues an alarm (H, L (only on printouts)). The last row of the field does not
allow an age limit to be defined. These expected values include patients older than the
upper limit of the second age group.
A C
B D
E
A Age threshold 1 C Range 1 (ages < age threshold 1)

B Age threshold 2 D Range 2 (ages < age threshold 2)
E Range 3 (ages > age threshold 2)
Figure B-119 Expected values
a To change expected values

Now, you can change the settings in the Expected Values area.
a To change normal-value ranges and corresponding age

1 In the Expected Values area, choose the first text box and enter a patient age for
cutoff of the first expected value range. Then select the unit (Day, Month, Year)
for that age in the list box.
2 Type the lower and upper normal-values for males in the Male area in the last
2 text boxes in the row for the specified test.
3 Repeat steps 1 and 2 for the second age cutoff in the second row of text boxes in
the Male area.
4 In the third row of text boxes, type the lower and upper normal-values for males
of all ages above the second age cutoff.
5 Repeat steps 1 to 4 for female age cutoff ranges.
Now, you can change the default settings.
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Application
a To change default settings

1 In the Default Sex area, select either the Male or Female option as the default if
no sex is specified.
2 In the Default Range area, select the default age range (Range 1, Range 2 or
Range 3) to be used if no age range is specified.
Description of application parameters - Others tab for ISE tests
The following section explains how to set up two independent sets of calibration
curves for different sample types for each ISE test Na+, K+, and Cl-.
To display this screen select Utility > Application > Others.
Figure B-120 Others tab on Utility > Application screen (ISE test)
Use the Others tab to set up two independent sets of calibration curves for different
sample types for each ISE test Na+, K+, and Cl-. Choose an ISE test from the test list to
display calibrator codes, concentration values, and disk position numbers.
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Application
Setting up individual calibration curves for each ISE sample type

The Others tab of the Na, CI and K contains two areas, ISE-A and ISE-B, where each
area relates to one of the two independent calibration curves.
To use these calibration curves for a specific sample type, the following settings have
to be done:
o Set the calibrators used for generating the calibration curve type A and B.
o Assign an ISE calibration curve for each sample type.
a To set the calibrators for calibration curve type A and B

1 On the Others tab of the Utility > Application screen select the ISE test to be
edited from the Test list on the left.
2 Enter the codes of the calibrators used for generating the calibration curve ISE-A
in the corresponding text boxes for each calibrator, Low, High and Comp.
3 Repeat steps 2 for calibration curve ISE-B.
4 Choose Save to save the changes made.
If only one calibration type is used—if you use the same calibration curve for all sample
types— then you must enter the same calibrator codes for ISE-A and ISE-B. It is not
possible to inactivate one of the calibrator curves.
a To assign an ISE calibration curve for each sample type

1 Choose Utility > System (Page 3/5) > ISE Calib Setting.
2 Select the calibration curve type (ISE-A or ISE-B) for each sample type.
3 Choose OK to save the changes made.

ISE calibration concept on page B-154
ISE calibration on page B-173
If a field is grayed out, the field is read only for the password level logged onto the system.
At an administrator level, if the field is not grayed out, it can be edited.
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System configuration
This section explains how to perform certain tasks associated with the Utility >
System menu.
e For a complete description of all fields and commands under the System menu, refer to
the Online Help.
The entire system parameter settings should be set before the other settings (control,
calibrator settings).
To display this screen, choose Utility > System.
Figure B-121 Utility > System screen
Programming system parameters on page B-236
Saving system parameters on page B-265
Restoring system parameters on page B-267
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Programming system parameters
Many system parameter settings can be customized according to your laboratory’s

needs. Your Roche technical representative programs these according to your
specifications during installation.
After (re)programming system parameters, it is strongly recommended that you make a

backup disk. However, some items cannot be saved to disk.
e See Saving system parameters on page B-265.
You can adjust the following system parameter settings:
System parameter screen/window

Position Assignment(a) Utility > System
Printer Page Size Utility > System
Set Date / Time Utility > System
Screen Saver Setting Utility > System
Test Name Order Utility > System
Barcode Setting Utility > System
Print Dilution Ratio Utility > System
Start Cell No. Incremental Utility > System
Wash Sampling cycles Utility > System
Sample Reception Setting Utility > System
3rd Results Acceptance Utility > System
Define Alarm Settings Utility > System (Page 1/5) > Alarm
Define Host Communication Settings Utility > System (Page 1/5) > Host Comm.
Define Comment Titles Utility > System (Page 1/5) > Comment
Assign Test Keys Utility > System (Page 1/5) > Key Setting
Define Test Group Names Utility > System (Page 1/5) > Key Setting
Add/Edit a test Profile Utility > System (Page 1/5) > Key Setting >
Profile Setting
Define QC Settings Utility > System (Page 1/5) > QC Setting
Define Reagent Level Check Alarms Utility > System (Page 2/5) > Reagent Level
Check
Activate Calibration Mask Settings Utility > System (Page 2/5) > Calib. Mask
Setting
Maintenance Settings Utility > System (Page 2/5) > Maintenance
Setting
Pipe Settings Utility > System (Page 2/5) > Pipe Setting
Power Up Pipe Settings Utility > System (Page 2/5) > Power Up Pipe
Setting
Assign Operator IDs Utility > System (Page 3/5) > Operator ID
Define Check Digit Settings - Barcode Mode Utility > System (Page 3/5) > Check Digit
Define ISE Calib Setting Utility > System (Page 3/5) > ISE Calib Setting
Define Sample Disk Setting Utility > System (Page 3/5) > Sample Disk
(Number of STAT samples) Setting
Table B-34 System parameters (Sheet 1 of 2)
(a) Can only be edited in Patient ID mode (Barcode Setting)
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System parameter screen/window

Check Diluents and Cleaners Utility > System (Page 3/5) > Dil. + Cln.
Setting
Activate Automatic Printout Utility > System (Page 4/5) > Automatic
Printout
Review By Exception Utility > System (Page 4/5) > Review By
Exception
False bottom tubes Utility > System (Page 5/5) > FBT Setting
Activate Automatic Rerun Start (global button)
Activate Host Communication Setting Start (global button)
Program Default Profiles Start (global button) > Default Profile
Set Alarm Sounds Alarm (global button) > Sound
Table B-34 System parameters (Sheet 2 of 2)
(a) Can only be edited in Patient ID mode (Barcode Setting)
1/5
2/5
3/5
4/5
5/5
Figure B-122 System parameters (administrator level)
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Using patient IDs
By default, the analyzer uses Sample IDs. If there are several sample types of the same
patient, each sample has a different ID.
Using Patient IDs means to assign the same ID to all samples types (serum/plasma,
urine, CSF, and supernatant) of one patient. To distinguish the different sample
types, they have to be assigned to different position areas on the sample disk.
To assign positions, the Patient ID mode has to be activated first. The Change button in
the Position Assignment area will only be displayed in this mode. Therefore you have to
delete all data in the Data Review screen.
a To assign position ranges for sample types

1 On the Utility > System screen, choose Change in the Barcode Setting area. The
Barcode Setting window is displayed.
2 Select Patient ID and choose OK.
3 On the Utility > System screen, choose Change in the Position Assignment area.
The Position Assignment window is displayed.
Figure B-123 Position Assignment window
Before performing this action, observe the following safety precaution:

o Incorrect results due to position mismatch on page B-4
4 With regard to routine and STAT samples, assign each of the positions for each of
sample types.
5 Choose OK to save the changes made.
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Using SBS mode (scan before sample stop)
The SBS mode function allows the analyzer to process open test requests
automatically without operator intervention in most cases. In some exceptional cases,
e For detailed information about this function, see
Open test requests on page B-112.
a To activate SBS mode

1 On the Utility > System screen, choose Change in the Barcode Setting area. The
Barcode Setting window is displayed.
Figure B-124 Utility > System > Barcode Setting window
2 Make sure that the STAT/Routine check box is selected.

3 Select S.B.S. mode and choose OK.
4 Choose Start (global button) and check the following settings:
o Make sure that automatic reruns are enabled at least for routine samples.
Otherwise neither additional tests nor previously unmasked tests can be
measured during SBS mode.
o Sample Reception mode can be used, but is not necessary.
5 Choose Utility > System (page 1/5) > Host Communication window.
Figure B-125 Utility > System (page 1/5) > Host Communication window
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6 Check the setting of the Ignore host orders for samples with already existing
1st results check box.
This check box determines which host orders are measured in SBS mode.
o Select this check box if host orders for tests which already have 1st results
should be ignored and not be measured again. In this case only additional
orders sent from host (manually via batch) will be measured, host requests for
rerun and 3rd results will be ignored.
o Deselect this check box if all orders from host should be measured in SBS
mode, even if not necessary. In this case the complete test selection sent from
host will be measured, resulting in unneccessary rerun orders.
Generating multiple results for a single test
It is always possible to generate 2 results for each test: 1st run and rerun. Select the
3rd Results Acceptance check box on Utility > System to expand the ability to
generate multiple results for a single test.
Description of 3rd Results When 3rd Results Acceptance is activated, it is possible to request a test more than
Acceptance two times after confirming a safety warning. Any third or subsequent result will
overwrite the previous rerun result.

Be aware that in non-barcode mode there is a risk of sample mismatch.
CAUTION Do not exchange or remove samples.
The repeated rerun is only performed if the previous rerun result has been sent to the
Host. In case the previous result is not transmitted prior to the repetition request, the
sample is not pipetted.
Preconditions for 3rd Results Before activating 3rd Result Acceptance it is necessary to check the following
Acceptance conditions.
a To activate 3rd Results Acceptance

1 Choose Start (global button) to open the Start Conditions window.
2 Verify if in the Host Setting area, that the Host communication is enabled. If not,
choose Change, select the Communication On check box, and choose OK.
3 Choose Workplace > Data Review > Send To Host and send all results to the
Host. Then delete all data from the database by choosing Delete All.
4 Choose Utility > System (Page 1/5) > Host Comm. > Text Setting.
5 Select the Manual Rerun TS check box and choose OK.
6 Choose Utility > System.
7 Select the 3rd Results Acceptance check box in the Other area.
8 Choose OK and confirm the warning message.
With this confirmation you allow the system to overwrite rerun results by third
and subsequent results.
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Repeat Limit Flag / With When this feature is enabled, the system utilizes the repeat limit flag and repeat limit
Automatic Rerun values as defined under Utility > Application > Range. Whenever a sample result is
outside the specified repeat limit for a particular test, a data flag >Rept / <Rept is
attached to each result.
e For information on how to define the repeat limit, see: Repeat limit on page B-230.
When the Repeat Limit Flag check box is selected, the With Automatic Rerun check
box also is available. If it is selected as well, the particular test for this is sample is
repeated with the same sample volume as the in the first run.
To perform automatic reruns, the automatic rerun function must be selected (Start (global
button) > Automatic Rerun).
e For more information about the Alarm Setting window, refer to the Online Help for that
particular window.
Host Communication settings
The Host Communication Setting window is used to define all Host computer
interface parameters. The parameters are defined during installation by a Roche
Service engineer and should not be changed as this may cause data transferring
problems.
The Host Communication Setting window is divided into 3 tabs, which are
described in the following.
Communication Setting tab
Figure B-126 Host Communication Setting window - Communication Setting tab
Use this tab to define the Host computer communication settings.

e For a detailed description, refer to the Host Manual.
e For information about the Ignore host orders for samples with already existing 1st
results check box, see:
Using SBS mode (scan before sample stop) on page B-239.
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Text Setting tab
Figure B-127 Host Communication Setting window - Text Setting tab
Use this tab to define the text settings used for Host communications.
The abbreviation TS stands for Test Selection.
e For a detailed description, refer to the Host Manual.
Result Upload Setting tab
Figure B-128 Host Communication Setting window - Result Upload Setting tab
Use this tab to define the upload settings used for the transfer of result data from the
analyzer to the Host.
Option Meaning
by sample All results of one sample are collected before uploading
ISE/Chemistry ISE and all clin.-chem. results are uploaded separately
by Test (only for STAT samples) As soon as the result is available
Table B-35 Routine Sample Host upload setting
No Automatic Result Upload When this function is enabled, no result is uploaded in real time. In this case, the
results can be uploaded manually by selecting samples from the Workplace > Data
Review screen and choosing Send To Host.
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Assigning tests or profiles to test keys
To display this window, choose Utility > System (Page 1/5) > Key Setting.
Figure B-129 Key Setting window
This window is used to assign tests or profiles to test keys. One test or profile can be
assigned to each test key. Tests can be assigned for up to 5 groups of 32 keys per
sample type. In total 160 test keys are available for each sample type.
a To define a group name

The group name can be defined individually, for example, TDM (Therapeutic Drugs
Monitoring), DAT (Drugs of Abuse Testing), or substrate.
1 Choose the sample type tab, for example, Ser/Pl.
2 Select the Group tab (Group 1 - 5).
3 Type the name of the group in the Group Name box.
The group name is not displayed on the Key Setting window. It is displayed in the
Test Selection screen.
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a To assign a test or a profile to a key

1 Choose a key on the Key Setting window. The Test Key Assignment window is
displayed.
Figure B-130 Test Key Assignment window
2 Select a test or a profile from the list and choose OK.
o If you want to delete a test key assignment, select Undefined at the end of the list.
o Before you can select a profile, the profile has to be defined.
a To define a profile
Profiles are sample type specific, this means the sample type has to be selected.
1 Choose the tab of a sample type on the Key Setting window, for example, Ser/Pl.
2 Choose Profile Setting on the Key Setting window. The Profile Setting window
is displayed.
Figure B-131 Profile Setting window
A maximum of 20 profiles in total can be defined in the Profile Name list.

3 Select an empty row in the Profile Name list.
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4 Type in the profile name in the Profile Name box.

5 Add the tests that should be included in the profile to the Assigned Test list.
6 Choose Update to update the information and choose OK to save the profile
settings.
7 If a profile is assigned to a key, the key is marked with a brown bar.
Maintenance / Pipe Setting / Power Up Pipe buttons
Configuration of Maintenance related items is described in the corresponding

maintenance chapters.
e For information, see:
Defining and editing maintenance types on page C-19
Sample Disk Setting button
Figure B-132 Sample Disk Setting window
Use this window to set the number of sample disk positions that are reserved for
STAT samples (0 to 53 positions). The assignment of the STAT positions is displayed
on the top left of the Utility > System screen.
At least one position should be reserved for a STAT sample!

If no position is reserved for a STAT sample and all positions are occupied by other
samples, the STAT sample can not be processed until another sample is removed from the
sample disk.
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Using false bottom tubes
Use this window to define the dimensions of false bottom tubes/cup on non standard
tubes. The following measures must be defined:
o Container height - the length of the tube: 73 mm - 102 mm
o Bottom Level (see Figure B-134): 0.1 mm - (Container height - 20) mm
If you use tubes with conical bottom, select Conical Bottom.
Figure B-133 False bottom/Cup on non-Standard tube Setting window
When using false bottom tubes or cup on non-standard tubes, the distance between
the upper edge of the tube and the bottom level must be more than 20 mm.
90 mm (for example)
Container Height
> 20 mm
Bottom Level
15 mm (for example)
Figure B-134 False bottom tube dimensions
o Note that only one false bottom tube or non-standard tube can be specified.
o The analyzer automatically detects whether a false bottom tube is set in a sample disk
position. You do not need to assign positions for false bottom tubes.
o For exact specifications of the sample containers, contact its manufacturer.
a To assign false bottom tubes

1 Choose Utility > System (Page 5/5).
2 Choose the FBT Setting button.
3 Enter the specifications of the relevant sample container.
Roche Diagnostics
Module Set
Module Set
This section explains how to perform certain tasks associated with entire modules
(photometric unit or ISE unit) rather than specific samples or tests. For the
cobas c 311 analyzer, the word module is used synonymously to unit.
The entire module set (module configuration, test assignment) should be performed before
the other settings (control, calibrator settings).
To display this screen, choose Utility > Module Set.

This screen can be accessed by an operator with service or administrator level
password only.
Figure B-135 Utility > Module Set screen
This screen is used to access the Test Assignment window.
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Module Set
Assigning a test
a To assign a test to the photometric or ISE unit

1 Choose Test Assignment on the Utility > Module Set screen. The Test
Assignment window is displayed.
Figure B-136 Test Assignment window
2 Select a test in the Test Name list box of the Test Assignment window.
3 Select the Assign check box.
4 Select the Mandatory check box if the reagent has to be on board all the time.
5 Select Na, K, Cl or Na, K.
o Na, K, Cl: This option allows sodium (Na+), potassium (K+) and chloride
(Cl-) ion testing on this ISE unit.
o Na, K: This option allows only sodium (Na) and potassium (K) testing on this
ISE unit.
6 Choose OK.
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Calculated Tests
Calculated Tests
This section explains how to program calculated tests and compensated tests.
To display this screen, choose Utility > Calc. Test.
Figure B-137 Calc. Test screen
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Calculated Tests
Programming calculated tests
Calculated test results are not performed on the system but are derived by applying a
test formula to the results of clinical chemistry tests performed on the analyzer. Yet,
test formulas are not to be applied on control material.
If test data to be used in the calculation is unavailable, the program does not perform
the calculation. Calculated test results cannot be edited. Use the following procedures
to add, edit or delete a calculated test formula.
Incorrect results due to modifying a calculated test formula

Editing a calculated test formula will change the calculated test result displayed on the
CAUTION Data Review screen.
Check the new formula for the calculated test before using it.
a To program a calculated test and enter a calculated test formula

1 Choose Utility > Calc. Test.
2 Select an empty line from the Calculated Test list at the top of the screen.
3 Choose Edit to display the Calculated Test Formula window.
Figure B-138 Calculated Test Formula window
4 Select the type of sample (Ser/Pl, Urine, CSF, Suprnt) for which the calculated
test formula is being created from the Sample Type list.
5 Type the unit of measure in the Unit Of Measure box.
6 Type a name for the calculated test as it should appear on the report in the Report
Name box.
7 Type the short name of the calculated test in the Test box.
8 Use the Test list to select a test that is part of the formula. After highlighting the
test, choose Select to add the test to the formula. The formula appears to the right
of the Test text box, after the equal sign. Use the Calculator area in the window to
enter mathematical operators and numerals in the correct sequence along with
test names until the formula is complete.
9 Now, set the range parameters.
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Calculated Tests
a To set range parameters

1 Choose the Range tab.
Figure B-139 Calculated Test Formula - Range tab
2 Type the expected value ranges or the qualitative parameters in the Range area, if
needed. Select the Default setting, if needed.
e For information about editing the expected values, see:
Expected values on page B-232
3 Choose OK to save the new formula and close the Calculated Test Formula
window. The new formula is shown in the Calculated Test list box at the top of
the Calc. Test screen.
The number of digits displayed to the right of the decimal in the calculated test result is
determined by the number of digits entered to the right of the decimal for the first
Male Expected Value field on the Range tab of the Calculated Test Formula
window.
4 Choose Utility > Report Format.

5 Select the defined test in the Print Order area.
6 Type an unused line number into the Line field.
7 Choose Update and Save to save the changes.
Roche Diagnostics
Calculated Tests
a To edit a calculated test formula

2 Select the calculated test formula to be edited from the Calculated Test list box at
the top of the screen.
3 Choose Edit to display the Calculated Test Formula window.
4 Use C in the Calculator area of the window to clear the entire formula or CE to
clear components of the formula one at a time from right to left.
5 Use the Test list to select the first test that is part of the formula. After
highlighting the test, choose Select to add the test to the formula. The formula
appears to the right of the Test text box, after the equal sign. Use the Calculator
area in the window to enter mathematical operators and numerals in the correct
sequence with test names until the formula is complete.
6 Choose the Range tab. Type the expected value ranges or the qualitative
parameters in the Range area, if needed. Change the Default settings, if needed.
7 Choose OK to save the formula programming and close the Calculated Test
Formula window. The revised formula appears in the Calculated Test list box at
the top of the Calc. Test screen.
a To delete a calculated test formula

2 In the Calculated Test list box, select the calculated test to be deleted.
3 Choose Delete to the right of the Calculated Test list box. A confirmation
window appears.
4 Choose Yes to delete the calculated test and close the window.
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Calculated Tests
Programming compensated tests
Clinical chemistry test results can be processed on the system and adjusted by
applying a compensated test formula. Use the following procedures to add, edit or
delete a compensated test formula.
a To enter a compensated test formula

2 Select an empty line in the Compensated Test list box at the bottom of the screen.
3 Choose Edit to display the Compensated Test Formula window.
Figure B-140 Compensated Test Formula window
4 Select the test and sample type to be compensated from the Test Name/Sample
Type list box in the upper left corner of the window.
5 Use the Test list to select any test that is part of the formula. Choose Select after
selecting the test to add it to the formula, which is shown at the top of the
window. Use the Calculator area to enter mathematical operators and numerals
in the correct sequence with test names.
6 Choose OK to save the new formula and close the Compensated Test Formula
window. The new formula is shown in the Compensated Test list box at the
bottom of the Calc. Test screen.
Roche Diagnostics
Calculated Tests
a To edit a compensated test formula

2 Select the compensated test formula to be edited from the Compensated Test list.
3 Choose Edit to display the Compensated Test Formula window.
4 Choose C in the Calculator area of the window to clear the entire formula, or CE
to clear components of the formula, one at a time, from right to left. Use the Test
list to select any test that is part of the formula. Choose Select after selecting the
test to add it to the formula, which is shown at the top of the window. Use the
Calculator area to enter mathematical operators and numerals in the correct
sequence with test names.
5 Choose OK to save the formula programming and close the Compensated Test
Formula window. The revised formula appears in the Compensated Test list box
at the bottom of the Calc. Test screen.
a To delete a compensated test formula

2 Select the compensated test formula to be deleted from the Compensated Test
list.
3 Choose Delete. A confirmation window is displayed.
4 Choose Yes to delete the compensated test and close the window.
Roche Diagnostics
Special Wash
Special Wash
The cobas c 311 analyzer is a random access system. Therefore, there is potential for
sample probe, reagent probe and reaction cell carryover and thus interferences
between tests.
To avoid carryover and cross-contamination between tests use the special wash
function. This function allows you to preset combinations of reagents or samples
where carryover may occur. The analyzer then performs a special wash cycle
whenever this combination is encountered during analysis.
The following section explains how to set the carryover avoiding function.
Programming a reagent probe wash
The reagent probe dips into the reagents when aspirating. To avoid a reagent
carryover, program a special wash cycle for the reagent probe.
e For more information refer to the package insert NaOHD/SMS/SmpCln 1 and the
carryover list.
a To program a reagent probe wash

1 Choose Utility > Special Wash.
Figure B-141 Special Wash screen
2 Select an empty line in the Reagent Probe list to add a reagent probe wash. To
edit an existing reagent probe wash, select the corresponding line.
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Special Wash
3 Choose Edit, on the right of the Reagent Probe list, to display the Edit Reagent
Probe Wash window.
Figure B-142 Edit Reagent Probe Wash window
4 In the From Reagent area, select the test name for the causal reagent in the Test
list box. Select the appropriate reagent type (R1, R2, or R3) in the Reagent Type
list box.
5 In the To Reagent area, select the test name for the affected test in the Test list
box. Select the appropriate reagent type (R1, R2, or R3) in the Reagent Type list
box.
6 Select the Detergent type (D1, D2, D3, or Water) from the Type list box for each
reagent probe selected.
o D1 = NaOH-D (application code 947)
o D2 = SMS (application code 948)
o D3 = SCCS (application code 949)
7 Then type the wash solution volume (from 20 to 180 L) in the Volume text box.
8 Choose OK to add the new special wash to the list on the Special Wash screen
and close the window.
9 Check the amount of the appropriate detergent cassette on the instrument on the
Reagent > Status screen.
a To delete a reagent probe wash

2 Select the line in the Reagent Probe list to be deleted.
3 Choose Delete located below the Reagent Probe area to delete the reagent probe
wash after confirmation.
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Special Wash
Programming a cell wash
To avoid the carryover of traces of the test mixture from one test to the next test
measured in that same reaction cell, program a special wash cycle for the reaction
cell.
a To program a cell wash

2 Select an empty line in the Cell list to add a cell wash. To edit an existing cell
wash, select the corresponding line.
3 Choose Edit located below the Cell area to display the Edit Cell Wash window.
Figure B-143 Edit Cell Wash window
4 Select a test from the Test list box that requires cell washing.
5 Select the R1 check box to activate a cell wash for this test.
6 If more than 180 L detergent solution is needed, select the R2 check box as well.
7 Select the Detergent Type (D1, D2, D3, or Water) from the Type list box.
o D1 = NaOH-D (application code 947)
o D2 = SMS (application code 948)
o D3 = SCCS (application code 949)
8 Enter the detergent solution volume (from 20 to 180 L) in the Volume text box.
After Sampling area

For the HbA1c application this window shows the After Sampling area additionally. In
this area you can define special washes for the hemolysate reaction cell. In this case a
special wash is carried out after the corresponding test was performed.
9 Choose OK to save the settings, add the programming to the Cell list box and
close the window.
10 Check the amount of the appropriate detergent cassette on the instrument on the
Reagent > Status screen.
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Special Wash
a To delete a cell wash

2 Select the test to be deleted from the Cell list.
3 Choose Delete located below the Cell list box to delete the cell wash after
confirmation.
Programming a sample probe wash
The sample probe dips into the sample when it aspirates sample liquid. To avoid a
carryover of sample liquid, program a special wash cycle for the sample probe.
a To program sample probe wash

2 Select an empty line in the Sample Probe list to add a sample probe wash. To edit
an existing sample probe wash, select the corresponding line.
3 Choose Edit located below the Sample Probe area to display the Edit Sample
Probe Wash window.
Figure B-144 Edit Sample Probe Wash window
4 Select a test from the Test list box.
The Whole Blood Detergent Type is only available when HbA1c calculation is
selected as the test. This will wash the sample probe after the whole blood sample is
pipetted.
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Special Wash
5 Select the detergent type from the Detergent Type list box.
This solution is used for washing the sample probe.
o 1 (Sample Cleaner 1)
o 2 (Sample Cleaner 2)
o 1+2 (D1+D2)
o water
The detergent aspiration volume is 45 L.
6 Choose OK to save the settings.
7 Check that the appropriate wash solution is placed on the instrument in the
correct position.
A (1) Sample Cleaner 1

B (2) Sample Cleaner 2
Figure B-145 Sample probe cleaners
8 Check the amount of the appropriate detergent on the Reagent > Status screen.
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Special Wash
a To delete a sample probe wash

2 Select the test to be deleted from the Sample Probe list.
3 Choose Delete located below the Sample Probe list to delete the sample probe
wash after confirmation.
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Report Format
Report Format
This section explains how to customize the report format of the patient report.
The patient report (Print (global button)> Workplace> Data Print) can be printed
in two formats: Monitor format or Report format. Only the Report format can be
customized.
Customizing patient report format
a To customize patient report format

1 Choose Utility > Report Format to display the Report Format screen.
Figure B-146 Report Format screen
Customizing the report format of the patient report consists of the following
steps:
o Choose the page layout.
e To choose the page layout on page B-262
o Define the title, the positions of all other items, and the print order.
e To define the title and the positions of all other items on page B-262
o Choose Save to save the changes.
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Report Format
a To choose the page layout

1 Select the number of reports per page (1 or 2) from the Report/Page list.
2 Type the page length in lines in the Page Length box.
o for US letter (8 1/2" x 11") type 66
o for A4 (21cm x 29,7 cm) type 72
3 Select the number of pages per sample (1 or 2) from the Page/Sample list.
4 Select the Report Format check box to print patient reports in report format or
deselect it to print in monitor format.
If automatic printout is activated (Utility > System (Page 4/5) > Automatic
Printout, select Calibration Monitor, Control Result, or Emergency Sample)
the Calibration, QC, and STAT patient reports are printed in the selected format
(report format or monitor format).
If you print the patient report from the Data Print screen (Print (global button)>
Workplace> Data Print) you can select the format regardless of the setting on the
Report Format screen.
a To define the title and the positions of all other items

1 Type the title to be used for the report header in the Title text boxes.
2 Assign a print line and column to each of the items of report information, as
appropriate.
Printout failures due to wrong assignment of print lines and columns

Take care of the maximum character length of the items, especially when assigning
more than one demographic item to a line. For example, if the arrived date is assigned
to line 4, column 47 and the arrived time is also assigned to line 4, it must be assigned
to column 56 or higher since the character length for the arrived date is 8. If the second
item is assigned to a column that is used by the first item, one of the items is not
printed or only partially printed.
Check that all items are printed out correctly before using this report format.
Roche Diagnostics
Report Format
a To alter the print order
Incomplete printout of results due to missing Print Order Line number

If there is no Line number defined, the result is not printed out or displayed in the
CAUTION Print View screen, although the test itself is measured. The setting of Line number
corresponds to the test order in the printout.
For each test, a Line number must be defined.
1 In the Print Order area, select the test from the list.
2 Type the line number on which the test is to print in the Line text box.
Overwritten items due to wrong assignment of Print Order Lines

Do not assign the same line number to a test that is assigned to any demographic
information in step 2 from To define the title and the positions of all other items on
page B-262.
3 Choose Update to update the print order information.

To check the report setup, print a report example from Print (global button) > Utility >
Report Example.
Roche Diagnostics
Report Format
Comparison of data monitor format and report format
Data Print report (monitor format)
Data Monitor 07/06/20 09:59
Ser/Pl N 001 ID 000448

07/06/18 ALTL GGTI2 CHO2A TP2 CA MG
10:34:03 6.2 29 3.16 71 6 1
Admin
Figure B-147 Data Print report (monitor format, barcode mode)
Data Print report (report format)
* HITACHI AUTOMATIC ANALYZER *
ID 000180 DATE 07/07/30 16:29:02

S.NO. N 001 OPERATOR ID admin
S.TYPE Ser/Pl Comment-001
AGE
SEX
DRAW DATE
DRAW TIME
PRE-DILUTED NO
TEST RATIO RESULT UNIT EXPECTED VALUE ALARM
ALTL 54.0 U/L ( -99999- 999999)
GGT liquid 46 U/L ( -99999- 999999)
CHO2A 2.40 mmol/L ( -99999- 999999)
SCRE2 111 umol/L ( -99999- 999999)
CREJ2 123 umol/L ( -99999- 999999)
TP2 66.0 g/L ( -99999- 999999)
CA 8.0 mg/dL ( -99999- 999999)
MG 2.1 mg/dL ( -99999- 999999)
GLUC2 5.1 mmol/L ( -99999- 999999)
Na 113 mmol/L ( -99999- 999999)
K 3.7 mmol/L ( -99999- 999999)
Cl 80 mmol/L ( -99999- 999999)
L 14
H 1
I 2
Table B-36 Data Print report (report format)
Roche Diagnostics
Saving system parameters
Use the following procedure to make a backup of system parameters. This

information can be restored by using the Read Floppy Disk option in the Parameter
Read/Write window, if required.
e See Restoring system parameters on page B-267.
a To save system parameters on a floppy disk

1 Switch on the system and wait until it is in standby mode.
2 Insert a new, blank floppy disk (3.5", 1.44 MB, formatted, PC compatible) into
disk drive A.
You can format a floppy disk using the maintenance item (13) Floppy Disk Utility, if
required.
3 Choose Utility > Maintenance.
Figure B-148 Maintenance screen
4 Select 1 Maintenance from the Maintenance Type list.

5 Select (14) Parameter Read/Write from the Maintenance Items list.
6 Choose Select to display the Parameter Read/Write window.
7 Select the Write Floppy Disk option and choose Execute to save parameters to
floppy disk after confirmation.
Do not eject the floppy disk when the access lamp of the floppy disk drive is lit.
8 When processing is complete, remove the floppy disk from the disk drive and set
aside for use later in this procedure.
Roche Diagnostics
The following system parameters are stored:
No. Item Details

1 Application parameters
2 Calculation test parameters
3 Carryover evasion for reagent probe and reaction cell
programming
4 Carryover evasion for sample probe
programming
5 Report format
6 System parameters Page size, Date format, QC settings, Calibration
mask settings, Barcode settings, Sample reception
settings, Screen saver settings, Automatic printout,
Print dilution ratio, Test name order
7 Alarm setting parameters
8 Host communication
parameters
9 Comment settings
10 Host communication
exception settings
11 Maintenance Log
12 Barcode check digit
parameters
13 Pipe function setting
14 Key setting parameters
15 Profile settings
16 Power up pipe settings
17 Reagent level check
parameters
18 ISE calibration settings ISE-A or ISE-B
19 Sample disk setting STAT position number
20 Start Cell No. Incremental
21 Scale setting for each graph
22 Start condition settings
23 Mandatory setting for each
test
24 Test assignment of ISE “Na, K” or “Na, K, Cl”
25 Host test code settings
26 Download settings cobas link settings
Table B-37 System parameters, stored by Parameter Read/Write function
Roche Diagnostics
Restoring system parameters
Use the following procedure to restore system parameters from a backup floppy disk.
a To restore system parameters to the system

2 Select 1 Maintenance from the Maintenance Type list on the left of the screen.
3 Select (14) Parameter Read/Write from the Maintenance Items list on the right.
4 Choose Select to open the Parameter Read/Write window.
5 Insert the floppy disk into the disk drive.
6 Select the Read Floppy Disk option.
7 Choose Execute and confirm with Yes to start loading the data.
This is the last page of Part B.
Roche Diagnostics
Roche Diagnostics
Maintenance C
12 Safety information for maintenance . . . . . . . . . . . . . . . . . . . . . C-3

13 General maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-5
14 Maintenance of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . C-31
cobas c 311 analyzer 12 Safety information for maintenance
Safety information for maintenance

Make sure that you have read and understood the chapter General safety information. The
following safety messages in particular are relevant:
Warning messages:
page A-9
page A-10
Caution messages:
Observe the system safety labels illustrated and described starting on page A-14.
Before performing any maintenance, read the following safety messages carefully. If
you ignore these safety messages, you may suffer serious or fatal injury.

o Whenever possible, keep the top cover and the front cover of the analytical unit closed.
cleaning pipetter probes), always put the analyzer in Maintenance mode or in
o Do not open the top cover while the analyzer is performing maintenance.
o Do not touch any parts of the instrument other than those specified.
o Observe all instructions given in this manual very carefully.
Fire and burns due to the use of alcohol

Alcohol is a flammable substance.
o Keep all sources of ignition (e.g. sparks, flames or heat) away from the analyzer when
conducting maintenance or checks using alcohol.
o When using alcohol on or around the instrument, use no more than 20 mL at a time.
Roche Diagnostics
Operator’s Manual · Version 2.0 C-3
12 Safety information for maintenance cobas c 311 analyzer
Incorrect results due to low level of incubator bath

If the water supply is insufficient, the incubator bath can not be filled up properly. An alarm
CAUTION will be issued.
o Check that the tap at the outlet of the water tank is open.
o Check that the external water supply is turned on and that the water pressure meets
requirements.
o When the cause is eliminated, perform maintenance item (4) Incubation Water
Exchange to refill the incubator bath.
e For information about water pressure, see Operating conditions on page A-71.
Malfunction due to spilled liquid

Any liquid spilled on the instrument may result in malfunction or damage of the analyzer.
o Do not place samples, reagents or any other liquid on the surface of the analyzer.
o When removing and replacing the reaction cells, be careful not spill water from the
incubator bath.
o If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be
sure to wear protective equipment.
Roche Diagnostics
C-4 Operator’s Manual · Version 2.0
cobas c 311 analyzer 13 General maintenance
Table of contents
General maintenance
This chapter provides general information about maintenance of the cobas c 311
analyzer. Concepts, such as maintenance pipes, maintenance pipe functions and
maintenance types are described as well as instrument care. Lists of maintenance
items and checks are also provided.

Overview ........................................................................................................................... C-7
Definitions ................................................................................................................. C-7
Maintenance concept ............................................................................................... C-8
Maintenance items .......................................................................................................... C-8
Performing maintenance items ............................................................................... C-9
Maintenance pipes ........................................................................................................ C-10
Defining and editing maintenance pipes ............................................................. C-11
Performing maintenance pipes ............................................................................. C-13
Deleting maintenance pipes .................................................................................. C-13
Using Maintenance pipe functions ...................................................................... C-14
Power Up Pipe function .................................................................................. C-14
Start Up Pipe function ..................................................................................... C-15
Sleep Pipe function ........................................................................................... C-16
Recommended maintenance pipes ....................................................................... C-17
Power ON pipe .................................................................................................. C-17
Sleep pipe ........................................................................................................... C-17
Weekly pipe ....................................................................................................... C-18
Maintenance types ........................................................................................................ C-19
Defining and editing maintenance types ............................................................. C-19
Tracking maintenance ............................................................................................ C-22
Maintenance report ...................................................................................................... C-23
List of maintenance items ............................................................................................ C-24
List of maintenance checks .......................................................................................... C-28
Roche Diagnostics
13 General maintenance cobas c 311 analyzer
Table of contents
Roche Diagnostics
Overview
Overview
Personal injury or damage to the analyzer due to non-observance of safety

information
o Before performing maintenance tasks on any part of the instrument, read the safety
notes for the corresponding maintenance item in the chapter on page C-3.
o It is the responsibility of the operator to properly care for and maintain the system in
order to ensure consistent and accurate functioning. Modifying or omitting the
maintenance procedures may result in a loss of performance or system reliability.
The part Maintenance contains information about the following topics:

o General maintenance
This is the current chapter. It describes the general maintenance concept and
software functions, which support you in performing maintenance tasks.
o Specific maintenance actions
The maintenance actions are described in the following chapter Maintenance of
the analyzer on page C-31.
All of the software screens shown in this part are used as examples only. Your screens
may differ depending on your system setup.
Definitions
Maintenance item A single maintenance procedure, such as (2) Photometer Check.

e For a list of maintenance items see List of maintenance items on page C-24
System-controlled maintenance Maintenance items that are performed without operator interaction (such as Air
Purge).
Operator-controlled Maintenance items that require operator interaction (such as Cleaning Sample
maintenance Probe).
User-definable maintenance Users may define their own maintenance items for the laboratory. User-definable
maintenance items are always maintenance actions that have to be performed
manually.
Maintenance pipe A combination of sequential maintenance items programmed into a fully automated
procedure, which can be performed by the analyzer without operator intervention.
Maintenance pipe function A function that automatically starts a maintenance pipe at a particular time (e.g., at
power-up).
Maintenance type A set of maintenance items (system-controlled, operator-controlled and user-

definable) and maintenance pipes grouped according to certain functions (such as
daily or weekly maintenance).
Roche Diagnostics
Maintenance items
Maintenance concept
Performing maintenance items Maintenance items can be performed manually on the Utility > Maintenance screen.
manually
Operator-controlled and user-definable maintenance items cannot be part of a
maintenance pipe. Thus they have to be performed manually.
e See Performing maintenance items on page C-9
Maintenance pipes—performing A maintenance pipe is a set of system-controlled maintenance items (batch set). You
maintenance items can use a maintenance pipe so that certain maintenance items occur in a certain
automatically sequence.
Before usage, maintenance pipes must be defined under Utility > System
(Page 2/5) > Pipe Setting. Up to 20 pipes can be defined and each pipe can have up
to ten maintenance items including parameters belonging to them.
Maintenance pipes can be executed in two different ways:
o Manually by the user
o Automatically by means of maintenance pipe functions at power up of the system
(Power Up Pipe function) or before start of analysis (Start Up Pipe function)
e For more information on maintenance pipes, see:
Maintenance types—scheduling Maintenance items and maintenance pipes can be grouped together in a maintenance
and tracking maintenance items type according to certain functions (such as daily or weekly maintenance).
Within a maintenance type you can assign maintenance intervals (Period) and
warning levels to each maintenance item and maintenance pipe. Thus, you can create
and customize a maintenance schedule for every periodic maintenance task.
If a maintenance item or a maintenance pipe has been scheduled, you can track its
status (date of last execution and warning level) on the Maintenance screen. The
status of maintenance types is also displayed on the System Overview screen.
Maintenance types are configured in Utility > System (Page 2/5) > Maintenance
Setting.
e For more information on defining and using maintenance types, see:
Defining and editing maintenance types on page C-19
Tracking maintenance on page C-22.
Maintenance report—recording The analyzer records the execution of maintenance items in the Maintenance
maintenance Report.
The Maintenance Report is requested through Print (global button) > Utility >
Maintenance Report.
e See Maintenance report on page C-23
Maintenance items
Maintenance items can be performed as a single item or grouped together to a

maintenance pipe.
Roche Diagnostics
Maintenance items
Performing maintenance items
This section describes how to perform a single maintenance item.

e For information about the available maintenance items, see:
List of maintenance items on page C-24
a To execute a maintenance item

1 Choose Utility > Maintenance to display the Maintenance screen.
Figure C-1 Maintenance screen
2 Choose an entry from the Maintenance Type list.

o The entries Maintenance and Check are predefined. They include only
maintenance items, no pipes.
o A self-defined maintenance type can include both: Maintenance items and
maintenance pipes.
3 Select the maintenance item to be performed from the Maintenance Item list.
4 Choose Select.
5 Define any parameters required.
6 Choose Execute.
The maintenance item is performed. The date of the maintenance item is
updated.
The date of execution will also be updated even if operation is interrupted due to an
alarm, etc. In this case, perform the relevant maintenance item again and terminate it
normally.
Roche Diagnostics
Maintenance pipes
Maintenance pipes
A maintenance pipe is a set of system-controlled maintenance items (batch set).

Using maintenance pipes saves time by allowing the system to perform a series of
maintenance items without operator intervention.
Be sure to note the relation between maintenance pipes and maintenance pipe
functions:
Maintenance pipes Before usage, maintenance pipes must be defined under Utility > System
(Page 2/5) > Pipe Setting. The name of a pipe is freely definable, e.g. Power On pipe.
Roche recommends using maintenance pipes for automating instrument care, but
there are no pre-defined pipes on the system by default.
Maintenance pipes can be executed manually by the user. Alternatively, they can be
executed automatically by means of maintenance pipe functions.
Maintenance pipe functions A maintenance pipe function triggers the system to start a maintenance pipe at one of
those three particular times (events):
o At power-up or wake up (Power Up Pipe function)
o Before start of analysis (Start Up Pipe function)
o Before entering sleep mode after the last maintenance item is completed (Sleep
Pipe function)
e Using Maintenance pipe functions on page C-14
Example The Power On pipe contains multiple maintenance items (Figure C-2). It can be
executed manually or be assigned e.g., to the Power Up Pipe function. In the latter
case, the pipe function will automatically start the maintenance pipe at power-up or
wake up.
Maintenance pipe:
Power On pipe Manual execution

- (4) Incubation Water Exchange
Automatic execution:
- (5) Air Purge
- (7) Reagent Prime Power Up Pipe function
- (2) Photometer Check
Start Up Pipe function
Figure C-2 Example of maintenance pipes and maintenance pipe functions
Note that:
o Power On is used as a name for a maintenance pipe. (This name is freely definable.)
o Power Up Pipe is a fixed name of a maintenance pipe function.
The following sections describe how maintenance pipes are defined, executed, and
deleted.
Roche Diagnostics
Maintenance pipes
Defining and editing maintenance pipes
Use the following procedure to program a series of maintenance items into a specific
maintenance pipe. Up to 20 maintenance pipes are definable and up to ten items can
be defined in each pipe. These items are performed one after the other. When a
maintenance item is performed as part of a pipe, an asterisk appears on the left side of
the date on the Maintenance Report.
e See Maintenance report on page C-23
a To edit a maintenance pipe or to define a new pipe

1 Choose Utility > System (Page 2/5) > Pipe Setting to display the Maintenance
Pipe Setting window.
Figure C-3 Maintenance Pipe Setting window
2 Choose an existing pipe in the Pipe Name list to edit the pipe or choose the first
blank line to define a new pipe.
3 Choose Edit to display the Edit Pipe window.
Figure C-4 Edit Pipe window
4 Type an unused name for the new pipe in the Pipe Name text box or edit the
name of the existing pipe if you want to change its name.
Roche Diagnostics
Maintenance pipes
5 Add a maintenance item to the Pipe Item List by choosing the maintenance item
on the Maintenance Item List, then choose Add.
For automatic transition to sleep mode after completion of a maintenance pipe,
select the Sleep check box.
6 Choose Parameter to define the parameters such as the number of cycles to be
performed depending on the maintenance item highlighted.
e For more information about the different maintenance items, see:
List of maintenance items on page C-24.
e For more information about the parameters of the different maintenance items, refer
to the Online Help for that particular window.
7 Choose OK to save the settings and return to the Edit Pipe window.
8 Repeat steps 5 to 7 for all items that are to be included in the pipe.
9 Delete items from the pipe by choosing the appropriate item on the Pipe Item
List, then choose Remove.
Items must be listed in the sequence that they are to be performed by the system. If the
items are not in the desired order, choose the item to be moved to highlight it, then
choose the appropriate arrow to move the item up or down in the list.
10 Choose OK when the pipe settings are complete. The pipe then appears in the
Pipe Name list in the Maintenance Pipe Setting window and as an option on
Utility > System (Page 2/5) > Power Up Pipe.
Roche Diagnostics
Maintenance pipes
Performing maintenance pipes
The pipe must have been defined as a maintenance type first (see Defining and editing
maintenance types on page C-19).
a To execute a maintenance pipe

1 Choose Utility > Maintenance to display the maintenance screen.
2 Follow the procedure to execute a maintenance item, see To execute a
maintenance item on page C-9.
The maintenance pipe is performed. The date of the maintenance pipe or item is
updated. If the pipe is defined as a Sleep pipe, the system will enter Sleep mode
after the pipe has been performed.
Deleting maintenance pipes
a To delete a maintenance pipe

1 Choose Utility > System (Page 2/5) > Pipe Setting.
2 In the Pipe Name list, select the name of the pipe to be deleted.
3 Choose Delete and confirm with Yes to delete the maintenance pipe.
Roche Diagnostics
Maintenance pipes
Using Maintenance pipe functions
Maintenance pipes can be performed automatically by the system by means of

maintenance pipe functions. The system provides three maintenance pipe functions,
which are described in the following.
Power Up Pipe function

Use the Power Up Pipe function to select a pipe to be performed at power up or wake
up of the system. However, the wake-up time takes effect only if the system was put in
sleep mode before (and not put into Shutdown status).
a To activate a Power Up pipe

1 Choose Utility > System (Page 2/5) > Power Up Pipe.
Figure C-5 Power Up Pipe window
2 Select the pipe to be performed at power up from the drop-down list box for each
day of the week.
3 In case you want to set a wake-up time, do the following:
o Select the check box to the right of the weekday for which you want to set a
wake-up time. (If the check box is deselected, the specified maintenance pipe
is executed manually, e.g after power up.)
o Set the time in the two boxes to the right of the check box.
4 Choose OK.
The PC will be restarted and the analytical unit initialized 10 minutes before the
specified time. Thereafter the maintenance pipe will be performed.
During sleep mode the wake-up time is displayed in the Logon window.
Roche Diagnostics
Maintenance pipes
Start Up Pipe function

The Start Up Pipe function is used to automatically perform a selected pipe before the
start of analysis.
a To activate a Start Up Pipe function

1 Choose Start (global button) or press the <F2> key to open the Start Conditions
window.
Figure C-6 Start Conditions screen (barcode mode)
The Start Up Pipe Setting area displays the maintenance pipe currently selected
as Start Up pipe. If no maintenance pipe is selected, None is displayed.
2 Choose Change in the Start Up Pipe Setting area.
3 Select the desired start up pipe from the list box on the Pipe Function window.
4 Choose OK to accept the change.
5 Choose Start (global button) to perform the displayed pipe.
After completion of the start up pipe, analysis will be started automatically.
Once the start up pipe begins, the Start Up Pipe Setting changes back to None.
Roche Diagnostics
Maintenance pipes
Sleep Pipe function

The Sleep Pipe function enables the system to enter in sleep mode after a pipe has
been performed. If the Sleep Pipe function is not activated (Sleep check box is not
selected), the system returns to Standby when a pipe is completed.
e For information about Sleep mode, see:
Analyzer shutdown and sleep mode on page B-81
a To activate the Sleep Pipe function

1 Choose Utility > System (Page 2/5) > Pipe Setting to display the Maintenance
Pipe Setting window.
2 Choose the pipe in the Pipe Name list to be performed as a sleep pipe.
3 Choose Edit to display the Edit Pipe window.
Figure C-7 Edit Pipe window
4 Select the Sleep check box to activate the Sleep Pipe function.
The system automatically enters Sleep mode after the pipe is completed.
e See Recommended maintenance pipes on page C-17
5 Choose OK to save the settings and return to the Maintenance Pipe setting
window.
Manual executing is required

The Sleep Pipe must be executed manually. After completion of the maintenance items,
the system would automatically go to Sleep.
Roche Diagnostics
Maintenance pipes
Recommended maintenance pipes
A maintenance pipe is a set of system-controlled maintenance items. This section

shows the maintenance pipes that Roche recommends for a proper use of the
analyzer. The maintenance items must be programmed in the order listed here for
the pipe to be performed correctly.
Automating instrument care We recommend using the maintenance pipe functions to perform maintenance pipes
automatically. This ensures a maximum of instrument care with minimal operator
intervention.
e For information about maintenance pipes and maintenance pipe functions, see:
Using Maintenance pipe functions on page C-14
Power ON pipe
We recommend performing this maintenance pipe by means of a maintenance pipe
function—either after initialization of the analyzer (Power Up Pipe function) or
before start of analysis (Start Up Pipe function).
Note that even though a maintenance pipe can be executed automatically some
maintenance items require visual checks by the operator.
Maintenance Item Page

(4) Incubation Water Exchange C-24
(5) Air Purge C-25
(7) Reagent Prime; select the REF option C-25
cobas link Essential Information Upload C-27
(2) Photometer Check(a) C-24
Table C-1 Recommended maintenance pipe—Power ON
(a) It can take up to 30 minutes after an (4) Incubation Water Exchange for the incubator to reach the
correct temperature (37  0.1C). Therefore perform the Photometer Check in a separate pipe if your
Power On pipe does not include a cobas link Essential Information Upload.

Sleep pipe
By use of the Sleep Pipe function the analyzer will automatically turn to sleep mode
after the maintenance pipe is completed.

(10) ISE Wash C-26
Table C-2 Recommended maintenance pipe—Sleep

Analyzer shutdown and sleep mode on page B-81
Sleep Pipe function on page C-16
Roche Diagnostics
Maintenance pipes
Weekly pipe
We recommend performing this maintenance pipe every week before shutdown or
start up.

(6) Wash Reaction Parts C-25
(3) Cell Blank Measurement C-24
Table C-3 Recommended maintenance pipe—Weekly
Before you shut down the analyzer, check the cell blank values in the Print View window.
The values will be lost after shutdown.
Roche Diagnostics
Maintenance types
Maintenance types
Maintenance items and maintenance pipes can be grouped together into a

maintenance type according to certain functions (such as daily, weekly, or monthly
maintenance).
By using maintenance types you can create a maintenance schedule. A separate
maintenance interval can be assigned to each maintenance item and maintenance
pipe within a maintenance type.
Predefined maintenance types Two Maintenance types are predefined: Maintenance and Check.
o Maintenance: Contains all available maintenance items except check routines
and service routines.
o Check: Contains all check routines.
Due time For each maintenance item or maintenance pipe, the control term (due time) is
definable. A maintenance item or pipe which has passed its scheduled term will be
indicated in yellow or red (depending on criticality) on screen:
o Indication in yellow: At warning level
o Indication in red: Due or overdue
Defining and editing maintenance types
Use the following procedure to group a series of maintenance items into a specific
maintenance type.
a To edit a maintenance type or define a new type

1 Choose Utility > System (Page 2/5) > Maintenance Setting.
Figure C-8 Maintenance Parameter Setting window
2 If a new Maintenance Type is to be defined, select a free line from the

Maintenance Type list, choose Edit, and proceed with step 3.
If an existing Maintenance Type is to be edited, select the appropriate line from
the Maintenance Type list, choose Edit, and proceed with step 4.
Roche Diagnostics
Maintenance types
3 Enter a name for the Maintenance Type in the text box at the top of the window.
Figure C-9 Edit Maintenance Type window
4 Select an item from the Maintenance Items list box.

This list includes both maintenance items and user-defined maintenance pipes.
5 If different parameter options are available, select the Maintenance Parameter
Setting check box to activate the Parameter button.
6 Choose Parameter to display the Maintenance Parameter window for the
selected maintenance item, if available. Use this window to define parameters for
the selected maintenance item.
e For more information about the different Maintenance Parameter windows, refer to
the Online Help for that particular window.
7 For maintenance tracking, enter the frequency period in the text box and select
the time period (Hours, Days, Months) from the Period list box.
If a frequency period is not required, enter 0 in the field to cancel.
8 Select a timer function from the Timer list box:
o Realtime: The actual time
o Power On: Cumulative power-on time of the analyzer (excluding sleep time)
o Operation: Cumulative operation time
Power On time and Operation time are both listed on the Maintenance
Report (Print > Utility > Maintenance Report).
e See Maintenance report on page C-23.
9 Enter the warning level (%) in the Warning Level text box.
Example:
If you define a period of 10 hours in real time and a warning level of 90%, the
analyzer will remind you to perform the maintenance item after 9 hours.
If a warning level is not required, enter 0 in the field to cancel.
10 By selecting the Comment check box you can add a comment during execution
that will be printed out on the Maintenance Report.
11 Choose Update to add the item to the Maintenance Items list.
Roche Diagnostics
Maintenance types
12 Repeat steps 3 to 11 for all maintenance items for the maintenance type.
13 Choose OK to save the group and its settings.
14 Choose Close to close the Edit Maintenance Type window.
Roche Diagnostics
Maintenance types
Tracking maintenance
If you have assigned a maintenance interval to a maintenance item or a maintenance

pipe within a maintenance type, the analyzer reminds you when a maintenance item
or pipe has to be performed.
Maintenance tracking is done on the Maintenance screen. The status of maintenance
types is also displayed on the System Overview screen.
a To display the maintenance status

1 Choose Utility > Maintenance to display the Maintenance screen.
The following information is displayed:

o The date the maintenance item or pipe was last performed.
o The maintenance type is highlighted in yellow or red if any item or pipe for
this maintenance type exceeds its warning level or its maintenance interval.
o The date in the item list is highlighted in yellow if the maintenance item or
pipe exceeds its warning level.
o The date in the item list is highlighted in red if the maintenance item or pipe
exceeds its maintenance interval.
2 If you need more information about the maintenance status of a particular
maintenance type, select a maintenance type and then a maintenance item or pipe
from the Maintenance Item list.
3 Choose Monitor to view the status of the selected maintenance item or pipe.
e For more information about the Maintenance Monitor window, refer to the Online
Help for that particular window.
Roche Diagnostics
Maintenance report
Maintenance report
The analyzer records the execution of maintenance items in the Maintenance

Report.
The Maintenance Report is requested through Print (global button) > Utility >
Maintenance Report. When a maintenance item is performed as a part of a pipe, an
asterisk appears on the left side of the date on the Maintenance Report.
Maintenance Report 07/06/20 14:27
POWER ON TIME 1847 HOURS

OPERATION 316 HOURS
MAINTENANCE TYPE: Maintenance Page 1

MODULE: Analyzer Unit
MAINTENANCE
DATE TIME OP.ID COMMENTS
Reset
07/06/20 09:53 Admin
07/06/20 09:27 Admin
07/06/19 16:37 Admin
… … …
Photometer Check
* 07/06/20 09:53 Admin
* 07/06/19 08:31 Admin
Cell Blank Measurement
07/06/19 15:57 Admin
Incubation Water Exchange
* 07/06/20 08:43 Admin
* 07/06/19 08:21 Admin
Air Purge
* 07/06/20 08:49 Admin
* 07/06/19 08:27 Admin
Wash Reaction Parts
Reagent Prime
* 07/06/20 08:51 Admin
* 07/06/19 08:29 Admin
Cell Detergent Prime
Incubator Bath Cleaning
* 07/06/19 08:58 Admin
ISE Wash
07/06/19 17:06 Admin
Sample Probe Wash
Flow Path Wash
Table C-4 Maintenance report
To print out a report for a certain maintenance item, choose Utility > Maintenance and
select the desired maintenance item. Then choose Print (global button).
e For more information about the Maintenance Report, refer to the Online Help for
that particular window.
Roche Diagnostics
List of maintenance items
The following section lists all maintenance items and a brief description of their
function. The time period in brackets denotes the approximate system time of the
maintenance item in (min:sec).
(ISE): Denotes that a function applies to the ISE unit only.
(P): Denotes that a function applies to the photometric unit only. In the maintenance
windows, the abbreviation AU is used to refer to the photometric unit (P).
(P+ISE): Denotes that a function applies to both units.

o Keep the top cover closed whenever performing one of the maintenance items or
checks listed below.
o Make sure that the analyzer is in Standby before executing a maintenance item or
check.
(1) Reset (P+ISE) (0:30): Mechanical parts are reset to their home positions.
(2) Photometer Check (P) (2:40): Photometer output is checked by measuring a water blank of cell no. 1.
Perform this maintenance item daily.
Check the photometer values on Print > Photometer Check. Measurement results
must be below 14000. If results are higher, check the light path; if necessary, replace
the photometer lamp, then perform a cell blank measurement.
Before performing this maintenance item, check that the incubator temperature is
within 37  0.1C (see System Overview screen on page B-44).
Depending on the ambient temperature it can take up to 30 minutes after switching
on the analyzer or after maintenance item (4) Incubation Water Exchange for the
incubator to reach the correct temperature.
e See To check the light intensity on page C-113.
(3) Cell Blank Measurement (P) (16:50): Water blanks of all cells are measured. If there is a difference greater than
0.1 absorbance units in the results for one cell compared to the cell No. 1, that cell
number is written to the Abnormal Cell List. To view this list choose Print (global
button) > View. Perform this maintenance item weekly.
e For information about the cell blank measurement, see:
To perform a cell blank measurement on page C-60
To check the Cell Blank Measurement report on page C-60.
(4) Incubation Water Exchange (P) (5:30): Incubator bath water is exchanged and Hitergent (4.3 mL) is added.
Perform this maintenance item daily. Incubator bath is also referred to as reaction
bath.
After this maintenance item has been performed, check that the incubator
temperature is within 37  0.1C (see System Overview screen on page B-44) before
performing maintenance item (2) Photometer Check. Depending on the ambient
temperature it can take up to 30 minutes for the incubator to reach the correct
temperature.
Roche Diagnostics
(5) Air Purge (P) (1:45): Any air is purged which may have become trapped in the sample and
reagent syringes. Water as well as any air are discharged at the rinse stations. Perform
this maintenance item daily.
With top cover closed, visually check that water is dispensed from the sample probe
and/or the reagent probe in a straight flow.
After air purge (in Standby mode), visually check the syringes and the tubing system
for leakage and air bubbles.
e See To perform an air purge (sample syringe or reagent syringe) on page C-106.
(6) Wash Reaction Parts (P) (29:30): All cells and probes are washed. The sample probe is washed with Sample
Cleaner 1 from the 70 mL detergent bottle (approx. 300 L). The reagent probe and
reaction cells are washed with detergent from a cobas c pack (NaOH-D, application
code 947, 26 mL).
Perform this maintenance item weekly or with new cells. If you are running DAT
assays, then perform this item daily. For more information please refer to the
instructions for use in cobas link of the assay.
e See To wash the reaction parts on page C-59.
(7) Reagent Prime (ISE): Reagents are primed according to the option chosen (IS+REF or REF).
Perform a REF reagent prime daily.
Whenever you replace either the ISE IS or ISE Ref. bottle, a reagent prime and an ISE
calibration must be carried out to fill the flow path with the new liquid and to
calibrate the ISE unit.
Options System Description Reagent

time consumption
IS+REF 9:30 Both ISE IS and ISE Ref. are primed. ISE IS: 9230 L
ISE Ref.: 1690 L
REF 1:50 ISE Ref. is aspirated through the reference ISE IS: 0 L
cartridge to prime the reference electrode. ISE Ref.: 3120 L
Table C-5 Reagent prime options
e For the REF option, see: To prime the ISE Ref. tubing on page C-75
For the IS+REF option, see: To prime lines on page C-90.
(8) Cell Detergent Prime (P) (8:55): Reagent lines for Cell Wash Solution I and II are primed; reagent lines are
purged of air and cells are filled up and emptied by vacuum.
You must select which detergents need to be primed (Detergent 1, Detergent 2, or
both). Perform when new bottles are loaded or when the filters are cleaned.
e See To perform a cell detergent prime on page C-79.
(9) Incubator Bath Cleaning (P): Performs transition to incubator bath cleaning mode: the photometer lamp is
switched off and the incubator bath water is automatically drained. Then the analyzer
will perform a complete system shutdown.
Switch off the analyzer after the control unit has powered off. After cleaning, power
on the analyzer as usual; the incubator bath is refilled with some water. A yellow
alarm is issued, indicating that the level of incubation water is below the lower limit.
Perform maintenance item (4) Incubation Water Exchange to exchange the
incubator bath water and to add Hitergent (4.3 mL).
Perform this maintenance item monthly to clean the incubator bath and the drain
filter, and quarterly to clean the ultrasonic mixer.
Roche Diagnostics
e See To remove reaction cells and to clean the incubator bath on page C-69
To clean the surface of the ultrasonic mixer on page C-93.
(10) ISE Wash (P+ISE) (28:15): The sample probe and the flow path of the ISE unit are washed. The
sample probe is washed with Sample Cleaner 1 from the 70 mL detergent bottle. The
ISE flow path is washed with SysClean from position W1 on sample disk. The ISE
electrodes are conditioned with Activator from position W2.
Perform this maintenance item daily if running ISEs. This item can be performed in a
sleep pipe.
Sleep pipe on page C-17
To wash ISE flow path, ISE electrodes and the sample probe on page C-50.
(11) Sample Probe Wash (P) (6:10 for 5 cycles): The sample probe is washed with Sample Cleaner 1 from the
70 mL detergent bottle (approx. 300 L). This item can be used in case of a clogged
probe.
e See To wash the sample probe on page C-123.
(12) Flow Path Wash (P) (20:30): The flow path, the drain port and the drainage tube of concentrated waste
solution are cleaned with CellCln II (detergent consumption: approximately 30 mL).
Perform this maintenance item monthly.
e See To wash the reaction system on page C-86.
(13) Floppy Disk Utility A floppy disk inserted into the floppy disk drive will be formatted after confirmation.
(14) Parameter Read/Write Parameter settings are read from or written to a floppy disk.
e See To save system parameters on a floppy disk on page B-265
See To restore system parameters to the system on page B-267.
(15) Test Count Write Test count is written to a floppy disk.
(16) QC Timer Reset (P): Resets the control interval timer.

For example, the control interval timer is set to 10 hours. When 5 hours are left, the
user can reset the timer to 10 hours.
Roche Diagnostics
cobas link Essential Information Important data such as calibrator and control data is uploaded and stored on the
Upload cobas link data station. The last 5 backups will be stored, the oldest backup will be
overwritten with the newest backup. Hence the last 5 backups are available to restore
to the analyzer if required.
It is recommended performing this maintenance item every day. This maintenance
item can only be performed in a maintenance pipe. Please contact either your Roche
service representative or technical support to include cobas link Essential
Information Upload in a maintenance pipe.
Roche Diagnostics
List of maintenance checks
The following section lists all maintenance checks and gives a brief description of
their function.
(1) Disk Check Files are checked on hard disk or floppy disk and a directory listing is printed out. If a
malfunction occurs, the system issues an alarm. The hard disk check can also be used
to determine the software version.
If the Backup Datafile option is selected, the system collects and stores system data
for maintenance purposes.
e For using the Backup Datafile option, see Backup of the system data files (getlog
procedure) on page D-53
(2) ISE Check (ISE) (18:00 for 10 cycles): The electrode output of ISE cartridges (Cl, K, Na and REF
cartridges) is measured with ISE IS and a listing of EMF values is printed out.
Perform this check twice after replacing the ISE cartridges and ISE tubing. Wait
10 minutes between each check.
e See To perform an ISE Check and calibrate the ISE unit on page C-90.
(3) Mechanisms Check (P+ISE) (9:30 for 30 cycles): Performs a functional check of mechanical parts of the
entire sample line of the analyzer (according to the number of cycles).
If the check box With Photo Interrupter Check is selected, the system checks
automatically all relevant photocoupler sensors during this maintenance function.
Only the defective sensors are shown in the Print View window.
Choose Stop (global button) to end this maintenance check. Perform this check as
needed after replacing the sample or reagent probe and after replacing the nozzle tips
on the cell rinse nozzles.
e See To perform a Mechanisms Check on page C-130.
(4) Barcode Reader Check (P) The barcode on a sample tube or cobas c pack is scanned. After pressing Stop, the
data are printed out for verification.
To check the function of the barcode reader:
o Select Sample Barcode Reader or Reagent Barcode Reader.
o In the former case, place a barcoded tube onto the sample disk and start the
Barcode Reader Check.
In the latter case, start the Barcode Reader Check and scan a cobas c pack.
If the check box With Photo Interrupter Check is selected, the system checks
automatically all relevant photocoupler sensors during this maintenance function.
Only the defective sensors are shown in the Print View window.
The reading results are shown in the Print View window.
(5) Probe Check (P+ISE) Puts the analyzer in probe adjust mode. In this mode, a probe—selected in
the Probe Check window—can be moved to designated positions by means of the
S.Stop button. As this function must be performed with closed cover, it is not
possible to sight check the alignment of the probe.
Select Stop to stop the Probe Check.
(6) Cuvette Mixing (P+ISE) (5:05 for 10 cycles): Performs a functional check on the ultrasonic mixer.
Roche Diagnostics
The reagent probe pipettes deionized water into the corresponding cuvette. Then the
cuvette is moved to the mixing position and ultra sonic mixing will be executed.
Perform this check after the quarterly cleaning of the ultrasonic mixer.
e See To check the intensity of the ultrasonic output on page C-95.
Roche Diagnostics
Roche Diagnostics
cobas c 311 analyzer 14 Maintenance of the analyzer
Table of contents
Maintenance of the analyzer
This chapter describes the maintenance actions required for correct and efficient
running of the cobas c 311 analyzer. The maintenance of both the ISE unit and the
photometric unit is discussed. The schedule of required periodic maintenance actions
(daily, weekly, monthly…) is provided as well as maintenance actions that are
performed as needed.

Maintenance schedules ................................................................................................ C-33
Overview of maintenance schedules .................................................................... C-34
Overview of daily maintenance schedules .................................................... C-34
Overview of maintenance schedules—weekly and longer intervals .......... C-35
Scheduling periodic maintenance tasks ......................................................... C-36
Brief description of maintenance schedules ........................................................ C-36
Daily maintenance—at power on or start up ................................................ C-37
Daily manual maintenance .............................................................................. C-38
Weekly maintenance ........................................................................................ C-39
Monthly maintenance ...................................................................................... C-40
Every two months maintenance ..................................................................... C-41
Quarterly maintenance .................................................................................... C-41
Every six months maintenance ....................................................................... C-42
As needed maintenance ................................................................................... C-43
Periodic replacement of parts ...................................................................................... C-45
Daily maintenance ........................................................................................................ C-46
M1: Washing ISE flow path and sample probe ................................................... C-47
M2: Cleaning pipetter probes and ISE sipper nozzle ......................................... C-51
M3: Cleaning cell rinse nozzles ............................................................................. C-55
M4: Cleaning the ISE drain port ........................................................................... C-57
Weekly maintenance .................................................................................................... C-58
M5: Washing the reaction parts ............................................................................ C-59
M6: Cleaning the cell covers .................................................................................. C-62
M7: Cleaning the rinse stations ............................................................................. C-65
Roche Diagnostics
14 Maintenance of the analyzer cobas c 311 analyzer
Table of contents
Monthly maintenance .................................................................................................. C-68

M8: Replacing reaction cells and cleaning incubator bath and drain filter .... C-68
M9: Cleaning the ISE Ref. aspiration filter .......................................................... C-73
M10: Cleaning the detergent aspiration filters ................................................... C-76
M11: Cleaning the radiator filter .......................................................................... C-80
M12: Checking and cleaning the water tank ....................................................... C-81
M13: Washing flow path of concentrated waste solution ................................. C-85
Every two months maintenance .................................................................................. C-87
M14: Replacing ISE measuring cartridges (Cl, K, Na) ...................................... C-87
Quarterly maintenance ................................................................................................. C-92
M15: Cleaning the ultrasonic mixer ..................................................................... C-93
M16: Replacing the ISE pinch valve tubing ......................................................... C-96
M17: Replacing the ISE sipper tubing .................................................................. C-98
M18: Replacing the syringe seals ........................................................................ C-101
Every six months maintenance ................................................................................. C-110
M19: Cleaning the inlet water filter .................................................................... C-110
M20: Cleaning the cooling fan ............................................................................ C-112
M21: Replacing the photometer lamp ............................................................... C-113
M22: Replacing the ISE reference cartridge ...................................................... C-119
As needed maintenance ............................................................................................. C-122
M23: Replacing sample and reagent probes—elimination of clogging ......... C-122
M24: Replacing nozzle tips on cell rinse nozzles .............................................. C-131
M25: Draining the vacuum tank ......................................................................... C-133
M26: Cleaning instrument surfaces ................................................................... C-134
Roche Diagnostics
Maintenance schedules
This section provides you with an overview of the maintenance actions that are
required for proper instrument care. The information is divided into a tabular
overview and a brief description of the maintenance actions.
The information is sorted according to the frequency with which the actions must be
performed.
Personal injury or damage to the analyzer

This section Maintenance schedules comprises only a brief description for operators who
are familiar with performing maintenance actions on the cobas c 311 analyzer.
o Observe the safety precautions given in the detailed description of the maintenance
actions (see also on page C-3).
o For the first several times, follow the detailed description of the maintenance actions as
listed below.
e For a detailed description of performing maintenance actions, see:
Monthly maintenance on page C-68
Every two months maintenance on page C-87
Quarterly maintenance on page C-92
Every six months maintenance on page C-110
As needed maintenance on page C-122
Incorrect results after longtime power off

If the instrument has been powered off for a week or more, accuracy may deteriorate.
CAUTION Check the instrument performance before starting up operation again. For performance
check details, consult your local service representative.
Roche Diagnostics
Overview of maintenance schedules
The intervals for maintenance and checkup recommended in this document are
independent of the system operation time unless otherwise noted (e g. maintenance
actions which are based on test count or time).

o Whenever possible, keep the top cover of the analytical unit closed.
o Make sure that the analyzer is in Standby before executing a maintenance item or
check.
o If a check or maintenance action requires open covers (e.g., cleaning pipetter probes),
always make sure that the analyzer is in Standby before using the maintenance switch
to put the analyzer into Maintenance mode (or before shutting down the instrument).
Overview of daily maintenance schedules
Action Mode(a) Operator System time Page

time (min) (min)
approx. approx.
Daily—at (4) Incubation Water Exchange SB 6 C-24
starting-up (5) Air Purge (All) SB 2 C-25
(Power ON pipe)
(7) Reagent Prime; select the REF option SB 2 C-25
cobas link Essential Information Upload SB C-27
(2) Photometer Check SB 3 C-24
Daily manual M2: Cleaning pipetter probes and ISE sipper nozzle MA/PO 3 (2)(c) C-51
maintenance(b) M3: Cleaning cell rinse nozzles MA/PO 3 (2) C-55
M4: Cleaning the ISE drain port SB/MA/PO 3 C-57
Check that the drain tube of the vacuum tank is empty SB/MA/PO 1 C-133
Empty the waste solution container SB/MA/PO 3 C-38
Daily—items M1: Washing ISE flow path and sample probe, includes SB 1 29 C-47
that can be (10) ISE Wash C-26
performed in a Only if running DAT assays: SB 1 58 C-59
Sleep Pipe (10) ISE Wash; plus (6) Wash Reaction Parts
Table C-6 Overview of daily maintenance schedules
(a) We recommend using the instrument status in bold, see Table C-8 on page C-35.
(b) Make sure to check the daily items either at the beginning or the end of each working session. See also Starting the analyzer on page B-38.
(c) A system time in brackets refers to the time for changing the instrument status before and after performing this maintenance item.
Roche Diagnostics
Overview of maintenance schedules—weekly and longer intervals
Action Mode(a) Operator System time Page

time (min) (min)
approx. approx.
Weekly M5: Washing the reaction parts(b) SB 1 47 C-59
M6: Cleaning the cell covers MA/PO 3 (2) C-62
M7: Cleaning the rinse stations MA/PO 5 (2) C-65
Monthly M8: Replacing reaction cells and cleaning incubator bath PO(c) 10 47 C-68
and drain filter
M9: Cleaning the ISE Ref. aspiration filter MA/PO 5 (2) C-73
M10: Cleaning the detergent aspiration filters SB/MA/PO 5 C-76
M11: Cleaning the radiator filter SB/MA/PO 5 C-80
M12: Checking and cleaning the water tank PO 10 C-81
M13: Washing flow path of concentrated waste solution SB 1 21 C-85
Every 2 months M14: Replacing ISE measuring cartridges (Cl, K, Na) MA/PO 10 56 C-87
Quarterly M15: Cleaning the ultrasonic mixer PO(c) 10 5 C-93
M16: Replacing the ISE pinch valve tubing MA/PO 6 46 C-96
M17: Replacing the ISE sipper tubing MA/PO 6 46 C-98
M18: Replacing the syringe seals MA/PO 15 10 C-101
Every 6 months M19: Cleaning the inlet water filter PO 5 C-110
M20: Cleaning the cooling fan PO 5 C-112
M21: Replacing the photometer lamp PO 10 17 C-113
M22: Replacing the ISE reference cartridge MA/PO 5 48 C-119
As needed M23: Replacing sample and reagent probes—elimination of PO(d) 7 12 C-122
clogging
M24: Replacing nozzle tips on cell rinse nozzles MA/PO 6 10 C-131
M25: Draining the vacuum tank SB/MA/PO 5 C-133
M26: Cleaning instrument surfaces MA/PO 1 C-133
Table C-7 Overview of maintenance schedules—weekly and longer intervals
(a) We recommend using the instrument status in bold, see Table C-8 on page C-35.
(b) Perform daily if running DAT (Drugs of Abuse Testing) assays. For more information please refer to the instruction for use in cobas link of the assay.
(c) Start the maintenance item (9) Incubator Bath Cleaning from Standby. Then power off the analyzer as described.
(d) Start the maintenance item (11) Sample Probe Wash from Standby. Then power off the analyzer as described.
Instrument statuses (modes) PO Power OFF (shutdown)

SB Standby mode
MA Maintenance mode (using the maintenance switch)
Table C-8 Abbreviations for instrument statuses (modes)

Instrument statuses on page B-40
Sleep pipe on page C-17.
Roche Diagnostics
Scheduling periodic maintenance tasks

Create a maintenance schedule that is customized to your laboratory’s individual
requirements. We recommend letting the analyzer software remind the operator of
all periodic maintenance tasks. You can do this by configuring maintenance types (in
Utility > System (Page 2/5) > Maintenance Setting). Within a maintenance type,
you can assign maintenance intervals (Period) and warning levels to each
maintenance item and maintenance pipe.
e For more information on scheduling maintenance tasks, see
Maintenance types—scheduling and tracking maintenance items on page C-8
Maintenance types on page C-19.
Brief description of maintenance schedules
The following section provides you with a brief description of the maintenance items
and maintenance actions that are required for proper instrument care.
Personal injury or damage to the analyzer

This section comprises only a brief description for operators who are familiar with
performing maintenance actions on the cobas c 311 analyzer.
o Observe the safety precautions given in the detailed description of the maintenance
actions (see also on page C-3).
o For the first several times, follow the detailed description of the maintenance actions
(see the following cross-references).
e For detailed description of performing maintenance actions, see:
Monthly maintenance on page C-68
Every two months maintenance on page C-87
Quarterly maintenance on page C-92
Every six months maintenance on page C-110
As needed maintenance on page C-122
Roche Diagnostics
Daily maintenance—at power on or start up

The following table provides you with an overview of the maintenance actions that
must be performed on a daily basis.
Checks before start-up of the There are various conditions that need to be checked before an analyzer start-up.
analyzer Therefore it is important to inspect the analyzer before starting up.
e For more information, see Start-up inspection on page B-38.
Maintenance items that can be Below is a list of maintenance items that are suitable for use in a maintenance pipe. In
performed in a Power Up pipe connection with the Power Up Pipe function this maintenance pipe will be executed
automatically at power or wake up on of the analyzer.
e For information about maintenance pipe functions, see:
Using Maintenance pipe functions on page C-14
e For information about power on and sleep pipes, see:
Item Description Page

(4) Incubation Water Power ON pipe C-24
Exchange Check that the temperature of the incubator is within 37  0.1C on the System Overview
screen before starting analysis.
(5) Air Purge Power ON pipe; select the All option C-25
With top cover closed, visually check that water is being discharged at all rinse stations as C-129
well as through sample probe and reagent probe.
After air purge (in Standby mode), visually check the syringes and the tubing system for C-108
leakage and air bubbles.
(7) Reagent Prime Power ON pipe; select the REF option C-25
cobas link Essential Power ON pipe C-27
Information Upload
(2) Photometer Check(a) Power ON pipe C-24
Check the photometer values on the Print View window. C-113
Table C-9 Instrument care - daily (power on)
(a) It can take up to 30 minutes after an (4) Incubation Water Exchange for the incubator to reach the correct temperature (37  0.1C). Therefore
perform the Photometer Check in a separate pipe if your Power On pipe does not include a cobas link Essential Information Upload.
Visual checks at power ON

Note that even though a maintenance pipe can be executed automatically some of the
maintenance items listed above require visual checks with top cover closed.
e See also: Start-up inspection on page B-38.
Roche Diagnostics
Daily manual maintenance

must be performed on a daily basis.
Action Description Page

M1: Washing ISE flow path o (10) ISE Wash: The inside of the sample probe is cleaned as well as the ISE flow path and C-47
and sample probe the electrodes; after cleaning, the ISE electrodes are reconditioned with Activator.
Sample probe detergent, position 1 (on the left of the shield pipe): SmpCln 1 (cycles: 5)
Pos. W1: SysClean (cycles: 15)
Pos. W2: Activator (cycles: 15)
o Only if running DAT assays: Perform M5: Washing the reaction parts additionally. For
more information please refer to the instructions for use in cobas link of the assay.
Can be included in a sleep pipe.
M2: Cleaning pipetter o Put the analyzer in Maintenance mode or Shutdown status. C-51
probes and ISE sipper o Clean the probes, the ISE sipper nozzle, and the shield pipe with gauze pads moistened
nozzle with alcohol (e.g., isopropyl alcohol or ethanol).
Upon detection of abnormal sample aspiration caused by a clot, the sample probe is washed
automatically by the analyzer.
M3: Cleaning cell rinse o Put the analyzer in Maintenance mode or Shutdown status. C-55
nozzles o Clean the nozzle tips of the cell rinse unit with gauze pads moistened with deionized
water.
M4: Cleaning the ISE drain o Use deionized water to rinse crystals from the outlet of the drain port at the rear of the C-57
port analyzer.
Check the drain tube of the o Check that the drain tube of the vacuum tank is empty. C-133
vacuum tank
Empty the waste solution o Empty the waste container for highly concentrated waste at the rear of the analyzer.
container Wear protective gloves when performing this procedure. Contents of the ISE drain port are
potentially biohazardous.
Table C-10 Instrument care - daily (before shutdown or sleep)
Roche Diagnostics
Weekly maintenance
must be performed on a weekly basis.

M5: Washing the reaction Perform this maintenance action daily, if DAT assays are performed on the analyzer. For C-59
parts more information please refer to the instructions for use in cobas link of the assay.
o (6) Wash Reaction Parts: Cleans sample probe with SmpCln 1 (300 L) and reagent
probe and reaction cells with NaOH-D from a cobas c pack (application code 947,
26 mL).
o (3) Cell Blank Measurement: Perform maintenance item (3) Cell Blank Measurement to
obtain new photometric reference.
o Check the cell blank values in the Print View window before you shut down the analyzer.
Can be included in a weekly pipe.
M6: Cleaning the cell covers o Put the analyzer in Maintenance mode or Shutdown status. C-62
o Wipe front and rear faces of cell covers using a gauze pad moistened with alcohol (e.g.,
isopropyl alcohol or ethanol).
o Wipe openings of cell covers using a cotton swab dipped in alcohol.
M7: Cleaning the rinse o Put the analyzer in Maintenance mode or Shutdown status. C-65
stations for the sample o Clean rinse stations using cotton swabs moistened with 2% Hitergent solution.
probe and the reagent probe o Inject 2% Hitergent solution (approx. 10 mL) into each rinse station.
o Inject deionized water (approx. 100 mL) into each rinse station.
o Clean the drying cylinders of both rinse stations with cotton swabs moistened with
alcohol.
Table C-11 Instrument care - weekly
Roche Diagnostics
Monthly maintenance
must be performed on a monthly basis.

M8: Replacing reaction cells Replacing the reaction cells: C-68
and cleaning incubator bath o Put the analyzer in (9) Incubator Bath Cleaning mode. The water is drained from the
and drain filter incubator bath and the control unit is powered off.
o Power off the analytical unit.
o Remove the cell rinse unit, the sipper covers and the reaction cells.
o Mount new reaction cells or continue with cleaning the incubator bath.
Cleaning the incubator bath and drain filter: C-69
o Make sure that the analyzer is still powered off.
o Clean incubator bath and photometer windows using lint-free gauze pads.
o Clean drain filter of incubator bath with tap water and rinse with deionized water.
o Put the reaction cells back in place.
o Return cell rinse unit, sipper cover and cell covers.
o Switch on the analyzer. A yellow alarm will indicate low level of incubator water.
o Perform maintenance item (4) Incubation Water Exchange to exchange incubator bath
water.
o Perform maintenance items (6) Wash Reaction Parts and (3) Cell Blank Measurement.
M9: Cleaning the ISE Ref. Clean aspiration filter each time you replace the ISE Ref. bottle but at least once a month. C-73
aspiration filter o Put the analyzer in Maintenance mode or Shutdown status.
o Remove the filter from the tube end.
o Clean the filter with tap water and rinse it with deionized water.
o Reset remaining volume if the reagent bottle is replaced.
o Perform maintenance item (7) Reagent Prime with the REF option selected.
M10: Cleaning the Clean aspiration filters, which are attached to the tube ends, each time you replace a C-76
detergent aspiration filters detergent bottle (CellCln I and CellCln II) but at least once a month.
o Remove the filter from the tube end.
o Wash the filter with tap water and rinse it with deionized water.
o Reset remaining volume if a detergent bottle is replaced.
o Perform maintenance item (8) Cell Detergent Prime and select the appropriate detergent.
M11: Cleaning the radiator o Clean the radiator filter and radiator fins with a vacuum cleaner. C-80
filter
M12: Checking and o Shut down the analyzer. C-81
cleaning the water tank o Turn off the external water supply.
o Disconnect the water tank and remove the float assembly.
o Visually check that the water is clear.
o If it is clear, empty the water tank and rinse it with deionized water three times.
o If not, clean with 0.5% sodium hypochlorite solution using a brush. Rinse tank
thoroughly with deionized water three times.
o Wipe float assembly with gauze pads moistened with deionized water.
o Replace tank filled at least 1/3 full with deionized water, then reconnect.
M13: Washing flow path of o (12) Flow Path Wash: Cleans flow path of concentrated waste solution with acidic C-85
concentrated waste solution detergent (CellCln II, approx. 30 mL).
Table C-12 Instrument care - monthly
Roche Diagnostics
Every two months maintenance

must be performed at least every two months.

M14: Replacing ISE Replace cartridges (Cl, K, Na) every two months or after 9000 tests, whichever occurs first. C-87
measuring cartridges (Cl, K, o Put the analyzer in Maintenance mode or Shutdown status.
Na) o Replace ISE measuring cartridges.
o Perform maintenance item (7) Reagent Prime (IS+REF).
o Perform maintenance check (2) ISE Check (two times with 10 minutes in between,
10 cycles each) to condition the electrodes. Then, calibrate the ISE unit.
Table C-13 Instrument care - every two months
Quarterly maintenance
must be performed on a quarterly basis.

M15: Cleaning the Cleaning: Include this maintenance in the monthly cleaning of the incubator bath. C-93
ultrasonic mixer o Put the analyzer in (9) Incubator Bath Cleaning mode. The water is drained from the
incubator bath and the control unit is powered off (shutdown).
o Power off the analytical unit.
o Remove the cell cover and the segment of reaction cells near the ultrasonic mixer.
o Wipe surface of ultrasonic mixer with a cotton swab moistened with 2% Hitergent
solution.
o Wipe off the detergent with a cotton swab moistened with deionized water.
o Put the reaction cells and the cell cover back in place. In case you are re-using used
reaction cells, be sure to put them back in their previous positions.
o Switch on the analyzer. A yellow alarm will indicate low level of incubator water.
o Perform maintenance item (4) Incubation Water Exchange to exchange the incubator
bath water.
o Perform maintenance check (6) Cuvette Mixing (10 cycles).
M16: Replacing the ISE Exchange: If possible, replace sipper tubing and pinch valve tubing at the same time. C-96
pinch valve tubing o Put the analyzer in Maintenance mode or Shutdown status.
and o Exchange the ISE pinch valve tubing.
M17: Replacing the ISE o Exchange the ISE sipper tubing. C-98
sipper tubing o Perform maintenance check (2) ISE Check (two times with 10 minutes in between,
M18: Replacing the syringe Exchange: Replace the syringe seals if they have been used for more than three months or C-101
seals after 112,500 tests for the sample syringe or reagent syringe (or 56,250 tests for the sipper
syringe, respectively), whichever occurs first.
o Put the analyzer in Maintenance mode or Shutdown status.
o Remove the syringe.
o Replace the syringe seals and reattach the syringe.
o When replacing the reagent syringe seals or sample syringe seals, perform maintenance
item (5) Air Purge.
o When replacing the ISE sipper syringe seals, perform maintenance item (7) Reagent
Prime (IS+REF).
o After the reagent prime or air purge (in Standby mode), check all connections for
leakages and the syringe barrel for air bubbles.
Table C-14 Instrument care - quarterly
Roche Diagnostics
Every six months maintenance

must be performed at least every six months.

M19: Cleaning the inlet o Shut down the analyzer. C-110
water filter o Turn off the external water supply.
o Place a 500 mL beaker beneath the inlet water manifold.
o Disconnect the inlet water hose.
o Clean the filter thoroughly with deionized water, then reinstall the filter.
o Turn on the external water supply.
M20: Cleaning the cooling o Shut down the analyzer. C-112
fan o Vacuum dust from the cooling fan at the rear of the analyzer.
M21: Replacing the Exchange: Replace the photometer lamp if it has been used for more than six months or C-113
photometer lamp 750 hours(a), or if a photometer check value exceeds 14000.
o Power off the analyzer. Wait 30 minutes for the photometer lamp to cool down.
o Replace the photometer lamp.
o Wait 30 min for the photometer lamp to stabilize, then perform maintenance item
(3) Cell Blank Measurement (necessary to compensate for a change in light intensity).
M22: Replacing the ISE Exchange: If possible, combine this replacement with the two-monthly replacement of the C-119
reference cartridge measuring cartridges (Cl, K, Na).
o Put the analyzer in Maintenance mode or Shutdown status.
o Replace ISE reference cartridge.
o Perform maintenance item (7) Reagent Prime (REF).
o Perform maintenance check (2) ISE Check (two times with 10 minutes in between,
Table C-15 Instrument care - every six months
(a) This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the analyzer by looking at the printed Maintenance
Roche Diagnostics
As needed maintenance
must be performed as needed.
Action Cause Measure Page

Waste solution Despite emptying the container at the beginning Empty the waste container at the rear of the
container for highly or at the end of the day, it can fill up in the course analyzer.
concentrated waste of a working session. Wear protective gloves when performing this
An alarm is issued when the waste container gets procedure. The contents of the waste container
too full. are potentially biohazardous.
M9: Cleaning the When replacing ISE reference solution bottle. o Put the analyzer in Maintenance mode or C-73
ISE Ref. aspiration An alarm is issued on the System Overview Shutdown status.
filter screen when the ISE reference solution bottle is o Remove the filter from the tube end.
empty (Reagent Preparing > Reagent o Wash the filter with tap water and rinse it
Load/Unload List). with deionized water.
o Reset remaining volume.
o Perform maintenance item (7) Reagent
Prime with the REF option selected.
M10: Cleaning the When replacing cell detergents (CellCln I or II) o Remove the filter from the tube end. C-76
detergent aspiration behind the front doors. o Wash the filter with tap water and rinse it
filters An alarm is issued on the System Overview with deionized water.
screen when a detergent bottle gets empty o Reset remaining volume.
(Reagent Load/Unload List in the Work Flow o Perform maintenance item (8) Cell
Guide) Detergent Prime.
Rinsing the sample When the sample probe gets clogged, this is o Perform maintenance item (11) Sample
probe – elimination automatically detected by the probe. Sampling Probe Wash.
of clogging stops and an alarm is issued. o If the clogging is not eliminated, clean the C-122
sample probe manually.
M23: Replacing Sample aspiration error occurs frequently. o Shut down the analyzer. C-122
sample and reagent An alarm for clogging of the sample probe occurs o Remove the probe, clean it, and eliminate
probes—elimination and is not reset after cleaning (maintenance item clogging.
of clogging (11) Sample Probe Wash). o If a probe is bent or damaged, replace it.
o Perform maintenance item (5) Air Purge.
A probe is bent or otherwise damaged.
With top cover closed, visually check that
Upon detection of abnormal sample aspiration water is dispensed from the tip of the probe
caused by a clot, the sample probe is washed in a straight flow.
automatically by the analyzer. o Perform maintenance check
(3) Mechanisms Check (30 cycles).
M21: Replacing the The lamp has been used for more than o Perform maintenance item (2) Photometer C-113
photometer lamp 750 hours(a). Check.
A photometer check value exceeds 14000. o If any of the current data exceeds 14000,
check the light path for contamination or
scratches. Check that cell no. 1 is at least
half filled with water.
o Shut down the analyzer. Wait 30 minutes
for the photometer lamp to cool down.
o Replace the photometer lamp.
o Wait 30 minutes for the photometer lamp
to stabilize.
o Perform maintenance item (3) Cell Blank
Measurement.
Table C-16 Instrument care - as needed (Sheet 1 of 2)
Roche Diagnostics
Action Cause Measure Page

M14: Replacing ISE The cartridge has been used for 2 months. o Put the analyzer in Maintenance mode or C-87
measuring cartridges The test count has reached 9000 tests. Shutdown status.
(Cl, K, Na) o Replace ISE measuring cartridges.
The slope value of the cartridge falls outside the
o Perform maintenance item (7) Reagent
normal range. See Figure C-32: ISE data alarms
Prime (IS+REF).
and corresponding slope values (EMF values) on
o Perform maintenance check (2) ISE Check
page C-87.
(two times with 10 minutes in between,
10 cycles each).
o Calibrate the ISE unit.
M18: Replacing the The syringe seals have been used for more than o Put the analyzer in Maintenance mode or C-101
syringe seals three months. Shutdown status.
The test count has reached 112,500 tests for the o Remove the syringe.
sample syringe or reagent syringe (or 56,250 tests o Replace the syringe seals and reattach the
for the sipper syringe, respectively). syringe.
o When replacing the reagent syringe seals or
sample syringe seals, perform maintenance
item (5) Air Purge.
o When replacing the ISE sipper syringe
seals, perform maintenance item
(7) Reagent Prime (IS+REF).
o Afterwards (in Standby mode), check all
connections for leakages and the syringe
barrel for air bubbles.
M24: Replacing The cell rinse nozzle tips are worn so that water o Put the analyzer in Maintenance mode or C-131
nozzle tips on cell remains in the reaction cell. Shutdown status.
rinse nozzles The replacement cycle is typically one to two o Remove the cell rinse unit.
years depending on conditions of use. o Replace nozzle tip.
o Attach the cell rinse unit.
o Check the alignment of the new nozzle tip.
o Perform a (3) Mechanisms Check
(30 cycles).
M25: Draining the Alarm (Liquid in Vacuum Tank) is issued. o Remove the cap holding the drain tube of C-133
vacuum tank the vacuum tank.
o Drain the waste solution into a beaker.
Clean up instrument Spills on the instrument surface could be o Put the analyzer in Maintenance mode or C-134
surfaces potentially biohazardous and may damage the Shutdown status.
surface. o Remove samples. Clean up spills
immediately using a paper towel moistened
with disinfectant.
o Check the cell covers for contamination. If
necessary, clean the cell covers using a
gauze pad moistened with disinfectant.
Table C-16 Instrument care - as needed (Sheet 2 of 2)
Roche Diagnostics
Periodic replacement of parts
Periodic replacement of parts
Some parts require periodic replacement for preventive maintenance. Replace these
parts regularly and in accordance with your workload and the recommendations
given in this document. For purchase, inform your local service representative of the
part number.
ISE unit Item As required 2 months 3 months 6 months Page

ISE measuring cartridges x(a) C-87
(Cl, K, Na)
ISE pinch valve tubing x C-96
ISE sipper tubing x C-98
Syringe seals x (b)
C-101
ISE reference cartridge x C-119
Table C-17 Periodic replacement of parts for the ISE unit
(a) Replace the ISE measuring cartridges after two months or after measuring 9000 samples.
(b) Replace the sipper syringe seals after three months or after measuring 56,250 samples.
Photometric unit Item As required Monthly 3 months 6 months Page

Reaction cells x C-68
Syringe seals x (a)
C-101
Photometer lamp x (b)
C-113
Sample and reagent probe x C-122
Nozzle Tips of cell rinse unit x C-131
Table C-18 Periodic replacement of parts for the photometric unit
(a) Replace the sample and reagent syringe seals after three months or after measuring 112,500 samples.
(b) Replace the lamp if the photometer check value exceeds 14000 or when used for more than 750 hours.
This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the
analyzer by looking at the printed Maintenance Report (Print > Utility > Maintenance Report).
Spare parts
For proper instrument care use only original spare parts provided by Roche.
o The necessary spare parts are listed in the description of the corresponding
maintenance action.
o To order spare parts, please contact your Roche representative.
Roche Diagnostics
Daily maintenance
Daily maintenance
In this section you will find all the maintenance actions that must be performed every
day.
Before performing any maintenance actions, observe the following safety

precautions:
o Infection and injury due to contact with instrument mechanism on page C-3
page A-9
e This section discusses the following maintenance actions:

M1: Washing ISE flow path and sample probe on page C-47
M2: Cleaning pipetter probes and ISE sipper nozzle on page C-51
M3: Cleaning cell rinse nozzles on page C-55
M4: Cleaning the ISE drain port on page C-57
Contamination of flow paths or pipetter probes may cause incorrect measurement

results or clogging. Therefore, make sure to regularly perform the stated maintenance
procedures.
The maintenance items listed in the Power ON pipe and the Sleep Pipe must also be
performed every day.
Sleep pipe on page C-17.
Roche Diagnostics
Daily maintenance
M1: Washing ISE flow path and sample probe
At the end of analysis each day, the ISE flow path and the sample probe have to be
washed. This is a combined maintenance procedure for both ISE and photometric
unit.
The inside of the sample probe is cleaned as well as the ISE flow path and the
electrodes; after cleaning, the electrodes are reconditioned with Activator.
This maintenance action comprises the following procedures:
1. To set the number of washing cycles
2. To check the detergents and ISE reagents for the amounts remaining
3. To wash ISE flow path, ISE electrodes and the sample probe (maintenance item
(10) ISE Wash)
Operator time: approximately 1 minute
System time: approximately 29 minutes
Materials required m Detergent and ISE reagent consumption:

e See Table C-19 on page C-48
o Roche recommends performing the cleaning of the ISE flow path and the sample probe
and the conditioning of the electrodes within a sleep pipe. Then you do not have to
perform this maintenance step manually. Make sure that there are sufficient quantities
of reagent remaining.
o Even if you are not using the ISE unit, you must nevertheless perform a wash after daily
operation. You can use either ISE Wash or Sample Probe Wash to do this.
e See Sleep Pipe function on page C-16.
a To set the number of washing cycles

1 Set the number of cycles for detergent pipetting:
o Choose Utility > System.
o Enter the number of cycles for both Photometric and ISE in the Wash
Sampling area (recommended are 5 cycles for Photometric and 15 for ISE).
2 Choose OK to save the settings.
Roche Diagnostics
Daily maintenance
a To check the detergents and ISE reagents for the amounts remaining
2 Choose System Overview > Reagent Overview button
A Sample Cleaner 1 (SmpCln 1) B ISE reagents
Figure C-11 Reagent overview screen
3 Check the detergents and ISE reagents for the amounts remaining in the Reagent
Overview screen.
o If inadequate, replace detergent or reagent bottles.
e See To replace ISE IS or ISE Dil. on page B-52.
e See To replace ISE reference solution (ISE Ref.) on page B-53.
e See To replace a sample probe detergent bottle on page B-142.
o Set detergents onto sample disk. Pipette suitable amounts of SysClean and
Activator into sample cups as shown in Figure C-12.
Detergents and reagents Name Position Consumption

Sample Cleaner 1 SmpCln 1 approx. 230 L
ISE cleaning solution SysClean W1(a) approx. 300 L
ISE Activator Activator W2 (a) approx. 300 L
Internal standard ISE IS approx. 22 mL
Diluent ISE Dil. approx. 6 mL
Reference solution ISE Ref. approx. 2 mL
Table C-19 Detergent and ISE reagent consumption (for 5 photometric washing cycles
and 15 ISE washing cycles)
(a) On the sample disk
Roche Diagnostics
Daily maintenance
A
F
A Sample Cleaner 1 (SmpCln 1) D Internal standard ISE IS

B W1: ISE cleaning solution SysClean E Diluent ISE Dil.
C W2: Activator F Reference solution ISE Ref.
Figure C-12 Positions of required reagents
If the amount of detergent in the cups is insufficient or if no cup is present, an alarm is

issued (ISE Cleaning Solution Short).
Roche Diagnostics
Daily maintenance
a To wash ISE flow path, ISE electrodes and the sample probe
2 Check the detergents and ISE reagents for the amounts remaining in the Reagent
Overview screen.
e See To check the detergents and ISE reagents for the amounts remaining on page C-48.
3 Place the cups on their positions W1 and W2.

5 Select Maintenance (1) from the Maintenance Type list on the left.
6 Select (10) ISE Wash from the Maintenance Items list on the right.
7 Choose Select to open the ISE Wash window.
8 Choose Execute.
The inside of the sample probe is cleaned as well as the ISE flow path and the
electrodes.
Make sure that you calibrate the ISE unit before you resume routine analysis.
e For details on how to calibrate the ISE unit, see:
Requesting and cancelling calibrations manually on page B-157.
If ISE wash is interrupted for some reason, perform maintenance item (6) Wash
Reaction Parts. Afterwards perform maintenance item (7) Reagent Prime and select
IS+REF.
e For information on how to perform these maintenance items, see:
M5: Washing the reaction parts on page C-59
To prime lines on page C-90.
9 If DAT (Drugs of Abuse Testing) assays are measured on the analyzer, perform
M5: Washing the reaction parts on page C-59 additionally.
Roche Diagnostics
Daily maintenance
M2: Cleaning pipetter probes and ISE sipper nozzle
At the end of analysis each day, clean the outside of the pipetter probes (sample
probe, reagent probe) and the ISE sipper nozzle to remove residual solution and
precipitation. This is a combined maintenance procedure for both ISE and
photometric unit.
Replace pipetter probes when they are bent or otherwise damaged.
When sample aspiration error occurs frequently or if an alarm for clogging of the
sample probe occurs and is not reset after cleaning (maintenance item (11) Sample
Probe Wash, page C-123), you must remove the sample probe and eliminate
clogging.
e For instructions on how to eliminate clogging, see:
M23: Replacing sample and reagent probes—elimination of clogging on page C-122
Operator time: approximately 3 minutes

Materials required m Lint-free gauze pads

m Paper towels
m Alcohol (e.g., isopropyl alcohol or ethanol)
Before performing this maintenance action, observe the following safety

precautions:
o Fire and burns due to the use of alcohol on page C-3
a To clean the outside of pipetter probes and ISE sipper

In both statuses, the pipetter probes can be easily moved by hand to accessible
positions.
To put the analyzer in Maintenance mode (yellow bar in status line) on page B-42
To shut down the analyzer on page B-83
Roche Diagnostics
Daily maintenance
Figure C-14 Cleaning the sample probe and the shield pipe
Use a new lint-free gauze pad for each probe to prevent cross-contamination. Be
careful not to soak the gauze pad so that liquid does not drip down into the reaction
cells.
3 Wipe (from top to bottom) the outside of the sample probe with gauze pads
moistened with alcohol.
4 Lift up the shield pipe and moving the sample probe by hand to a position above
the sample disk.
5 Also wipe the shield pipe with a gauze pad moistened with alcohol.
Roche Diagnostics
Daily maintenance
A Screw on the right side of the sipper cover

B Two screws on the left side of the sipper cover
Figure C-15 Cleaning the ISE sipper nozzle and the reagent probe
6 Remove the sipper cover:

o Loosen and remove the screw on the right side (A).
o Loosen the two screws on the left side (B).
7 Wipe (from top to bottom) the outside of the sipper nozzle with a gauze pad
8 Attach the sipper nozzle cover.
9 Wipe (from top to bottom) the outside of the reagent probe with gauze pads
Roche Diagnostics
Daily maintenance
10 Close the top cover of the analyzer and lock it (or: continue with the next
maintenance action using Maintenance mode).
if it was in Shutdown status). The analyzer returns to Standby.
12 Perform a Reset in Utility > Maintenance to return all mechanical parts to their
home positions.
Roche Diagnostics
Daily maintenance
M3: Cleaning cell rinse nozzles
At the end of analysis each day, clean the cell rinse nozzles. Regular cleaning prevents
contamination, crystal formation, and clogging.
Replace the nozzle tip if it has worn down. The replacement cycle is typically 1 to
2 years, depending on the conditions of use.
e For instructions on how to replace nozzle tip, see:
M24: Replacing nozzle tips on cell rinse nozzles on page C-131


m Cleaning wire (stainless steel) of 0.5 mm diameter
m Deionized water
Roche Diagnostics
Daily maintenance
a To clean the cell rinse nozzles

Figure C-16 Dismounting the cell rinse unit and cleaning the nozzles
3 Loosen the retaining screw of the cell rinse unit and lift off the entire unit.
4 Moisten a lint-free gauze pad with deionized water and gently wipe all tips of the
cell rinse nozzles in a downward motion.
5 If a nozzle is clogged, insert the probe cleaning wire (stainless steel wire, 0.5 mm
diameter) into the tip of the nozzle and eliminate the clogging.
6 Attach the cell rinse unit.
9 Perform a Reset in Utility > Maintenance to return all mechanical parts to their
home positions.
Roche Diagnostics
Daily maintenance
M4: Cleaning the ISE drain port
At the end of analysis each day, clean the outlet of the ISE drain port. Regularly
perform this maintenance to prevent the accumulation of crystals and clogging of the
drain port.

m Deionized water

precautions:
page A-10
a To clean the outlet of the ISE drain port
Figure C-17 Cleaning the ISE drain port
1 The analyzer can be either in Standby, Maintenance mode, or Shutdown status.

2 Use deionized water to rinse crystals from the outlet of the ISE drain port at the
rear of the analyzer.
3 Wipe up spilled water.
Roche Diagnostics
Weekly maintenance
Weekly maintenance
In this section you will find all the maintenance actions that must be performed at
least once a week.

precautions:
page A-9

M5: Washing the reaction parts on page C-59
M6: Cleaning the cell covers on page C-62
M7: Cleaning the rinse stations on page C-65
M12: Checking and cleaning the water tank on page C-81
The maintenance items listed in the weekly pipe must also be performed.
Weekly pipe on page C-18.
Roche Diagnostics
Weekly maintenance
M5: Washing the reaction parts
Contamination of the reaction cells or the waste solution flow path will result in
incorrect measurement results. Wash the reagent probe and reaction cells at least
once a week. Perform this maintenance action daily, if DAT (Drugs of Abuse
Testing) assays are performed on the analyzer. For more information please refer to
the instructions for use in cobas link of the assay.
After washing the reaction system, perform a cell blank measurement to check the
condition of the reaction cells.
System time: approximately 47 minutes (30 minutes for (6) Wash Reaction Parts and
17 minutes for (3) Cell Blank Measurement)
1. To wash the reaction parts (maintenance item (6) Wash Reaction Parts)
2. To perform a cell blank measurement (maintenance item (3) Cell Blank
Measurement)
3. To check the Cell Blank Measurement report
a To wash the reaction parts

2 Check how much detergent remains for the sample probe, reagent probe and
reaction cells. If the quantity is insufficient, add new detergent.
o For Sample Cleaner 1: Choose System Overview > Reagent Overview in the
Inventory area.
o For reagent probe and reaction cell detergent: Choose System Overview >
Reagent Overview in the Reagent area.
Detergent Reagent Consumption

Sample probe detergent Sample Cleaner 1 approximately 300 L
Reagent probe and reaction NaOH-D cassette approximately 26 mL
cell detergent (application code 947)
Table C-20 Detergent consumption for washing reaction parts
o If it is necessary to replace a detergent bottle or to add a new cobas c pack, see:

e To load a cobas c pack on page B-55
e To replace a sample probe detergent bottle on page B-142

4 Choose Maintenance (1) on the Maintenance Types list on the left.
5 Choose (6) Wash Reaction Parts on the Maintenance Items list on the right.
6 Choose Select to open the Wash Reaction Parts window.
Roche Diagnostics
Weekly maintenance
7 Choose Execute.
The procedure is finished when the analyzer returns to Standby.
8 Perform a cell blank measurement.
e See To perform a cell blank measurement on page C-60
a To perform a cell blank measurement

2 Choose (3) Cell Blank Measurement on the Maintenance Items list on the right.
3 Choose Select to open the Cell Blank Measurement window.
4 Choose Execute.
After performing the cell blank measurement, the Cell Blank Measurement
report will be printed automatically.
5 Check the Cell Blank Measurement report if replacement of reaction cells is
required.
e See To check the Cell Blank Measurement report on page C-60
a To check the Cell Blank Measurement report

1 If no printed Cell Blank Measurement report is available, it can also be printed
manually. Choose Print (global button) > Utility > Cell Blank Measurement.
2 Check if any cells are listed in the Abnormal Cell List area at the top of the report.
Whenever the cell blank value of a reaction cell falls out of the normal range, that
reaction cell’s number is printed in this area. These cells will be excluded from
measurements.
Normal cell blank values are:
o Value < 14 000 for the no. 1 cell and
o A difference between the no. 1 cell and all other cells of less than  1000
( 0.1).
3 If only a few cells are listed in the Abnormal Cell List area, you can continue
without any further action.
If more than about 5 reaction cells are affected, remove all reaction cells from the
reaction disk and replace the listed cells by new ones.
e For detailed informations, see To remove reaction cells and to clean the incubator bath
on page C-69
The reaction cell numbers are inscribed on the reaction disk.
Roche Diagnostics
Weekly maintenance
Cell Blank Measurement 07/06/20 14:26
--------------------------------------- ABNORMAL CELL LIST ---------------------------------------
07/06/19 14:43 --------------------------------- WAVELENGTH (nm) ---------------------------------
CELL NO. 340 376 415 450 480 505 546 570 600 660 700 800
001 12953 11414 11152 10756 10519 10333 10057 9918 9705 9442 9283 8938
002 12972 11444 11170 10771 10534 10350 10072 9932 9717 9459 9299 8952
003 12973 11446 11172 10776 10538 10354 10075 9934 9719 9459 9297 8949
004 12976 11444 11172 10775 10538 10354 10075 9933 9716 9455 9296 8949
005 12991 11468 11191 10793 10555 10369 10091 9949 9734 9475 9314 8963
006 12985 11460 11184 10790 10553 10367 10088 9947 9730 9469 9309 8959
007 12975 11450 11177 10780 10544 10359 10080 9938 9722 9462 9304 8954
008 12949 11413 11148 10752 10513 10327 10049 9909 9695 9436 9276 8930
009 12970 11451 11175 10779 10540 10356 10079 9937 9723 9465 9307 8956
010 12964 11433 11165 10771 10532 10346 10068 9927 9712 9449 9290 8940
… … … … … … … … … … … … …
065 12950 11423 11157 10763 10526 10341 10063 9922 9709 9446 9288 8943
066 12965 11440 11169 10775 10538 10354 10077 9937 9723 9462 9303 8956
Table C-21 Example of a Cell Blank Measurement report with Abnormal Cell List
Roche Diagnostics
Weekly maintenance
M6: Cleaning the cell covers
Two cell covers protect the contents of the reaction cells from light. Some reactions
are light sensitive and intrusion of light could lead to faulty measurements. The cell
covers also serve to prevent contamination by reagents. If reagent adheres to the front
or rear face of a cell cover, the analytical accuracy may decrease.
At the end of analysis each day, check the cell covers for contamination. Clean the cell
covers at least once a week.
Materials required m Cotton swabs

m Lint-free gauze pads
m Deionized water

precautions:
a To clean the cell covers

Figure C-18 Removing cell covers
3 Remove the cell covers.
Roche Diagnostics
Weekly maintenance
6/7
A U-cover
Figure C-19 Cleaning cell covers and U-cover
4 Wipe the front and rear faces of the cell covers using a gauze pad moistened with
alcohol.
5 Wipe the openings of cell covers using a cotton swab moistened with alcohol.
6 Pinch the sides of the U-cover (A) and pull it off the cell cover.
7 Wash the U-cover with deionized water. In case dust and dirt do not come off,
wipe the U-cover using a cotton swab moistened with alcohol.
In case you are also performing monthly maintenance, we recommend
continuing with the following action:
e See M8: Replacing reaction cells and cleaning incubator bath and drain filter on
page C-68.
8 Attach the dried U-cover and put the cell covers back in place.
Roche Diagnostics
Weekly maintenance
home positions.
Roche Diagnostics
Weekly maintenance
M7: Cleaning the rinse stations
Clean the rinse stations of the sample probe and the reagent probe at least once a
week to prevent bacterial growth or precipitation that may clog the rinse stations.
Materials required m 50 mL syringe with tubing

m Cotton swabs
m 2% Hitergent solution
m Deionized water

precautions:
o Malfunction due to spilled liquid on page C-4
a To clean the rinse stations

In both statuses, the pipetter probes can be easily moved by hand to accessible
positions.
Maintenance mode on page B-42
To shut down the analyzer on page B-83
Roche Diagnostics
Weekly maintenance
5
3 6
B C
A Rinse station C Drying cylinder

B Tip water aspiration position
Figure C-20 Cleaning the rinse station of sample probe
3 Using a cotton swab moistened with 2% Hitergent solution, clean the inside of the
sample probe rinse station.
Be careful not to splash liquid (water or Hitergent) into the drying cylinder.
4 Inject about 10 mL of 2% Hitergent solution into the sample probe rinse station.
5 Inject about 100 mL of deionized water into the rinse station to rinse it.
6 Wipe the drying cylinder (used for vacuum suction in the sample probe rinse
stations) with a cotton swab moistened with alcohol.
Roche Diagnostics
Weekly maintenance
3
5
6
A B
A Rinse station B Drying cylinder
Figure C-21 Cleaning the rinse station of reagent probe
7 Clean the rinse station and the drying cylinder for the reagent probe in the same
way as you clean the sample probe rinse station.
home positions.
Roche Diagnostics
Monthly maintenance
Monthly maintenance
least once a month.

precautions:
page A-9

M8: Replacing reaction cells and cleaning incubator bath and drain filter on page C-68
M9: Cleaning the ISE Ref. aspiration filter on page 73
M10: Cleaning the detergent aspiration filters on page C-76
M11: Cleaning the radiator filter on page C-80
M13: Washing flow path of concentrated waste solution on page C-85
M8: Replacing reaction cells and cleaning incubator bath and drain filter
Replace the reaction cells once a month because they gradually deteriorate over a
prolonged period of use. We recommend cleaning the incubator bath and incubator
bath filter at the same time.
Contamination inside the incubator bath (reaction bath) or on the photometric
window will reduce the reproducibility of measurement results. Clean the incubator
bath and photometric window at least once a month.
1. To remove reaction cells and to clean the incubator bath
2. To clean the drain filter of the incubator bath
3. To reinstall reaction parts and to terminate the incubator bath cleaning mode
System time: approximately 47 minutes (30 minutes for (6) Wash Reaction Parts and
17 minutes for (3) Cell Blank Measurement)
Materials required m Hitergent cassette (surfactant for the incubator, consumption 4.3 mL)
m Deionized water or 2% Hitergent solution

precautions:
Roche Diagnostics
Monthly maintenance
a To remove reaction cells and to clean the incubator bath

1 Switch on the analyzer (if it was in Shutdown status).
2 Choose System Overview > Reagent Overview screen.
3 Check the remaining amount of Hitergent. If insufficient, add a new cobas c pack.
4 Put the analyzer in incubator bath cleaning mode:
o Choose Utility > Maintenance.
o Select Maintenance (1) from the Maintenance Type list on the left.
o Select (9) Incubator Bath Cleaning from the Maintenance Items list on the
right.
o Choose Select to open the Incubator Bath Cleaning window.
o Choose Execute. The water is drained from the incubator bath and the control
unit is powered off (shutdown).
5 After the computer power supply has powered off, switch off power for the
analytical unit.
Do not open the top cover until the analyzer is in shutdown.
Figure C-22 Removing cell rinse unit and segments of reaction cells
7 Remove the cell rinse unit, the sipper cover and the cell covers.
Roche Diagnostics
Monthly maintenance
8 Remove each segment of the reaction cells from the reaction disk. Be careful not
to touch the surfaces of the reaction cells.
11 10
A Indented part of ultrasonic mixer
Figure C-23 Cleaning the incubator bath
While the analyzer is in Maintenance mode or Shutdown status, perform the

following to clean the incubator bath.
9 Using a clean lint-free gauze pad, wipe the inside surfaces of the incubator bath.
NOTICE Damage to the photometer windows

o Do not scratch the photometer windows when cleaning.
o Use only gauze pads moistened with deionized water or 2% Hitergent solution.
10 Moisten a clean lint-free gauze pad with deionized water or 2% Hitergent

solution. Wipe the photometer windows carefully in order to avoid scratching
them.
11 Wipe the surface of the ultrasonic mixer (A) with a cotton swab moistened with
DI water.
Now, continue with the next procedure: To clean the drain filter of the incubator
bath.
Roche Diagnostics
Monthly maintenance
a To clean the drain filter of the incubator bath
Figure C-24 Removing the drain filter of the incubator bath
1 Remove the incubator bath drain filter. Grasp the filter by its handle and pull the
filter out.
2 Wash the filter with tap water, rinse it with deionized water and return it to its
place.
In case you are only performing monthly maintenance, continue with the next
procedure: To reinstall reaction parts and to terminate the incubator bath
cleaning mode.
Otherwise we recommend continuing with the following items:
e For quarterly maintenance, see
M15: Cleaning the ultrasonic mixer on page C-93
e For every six months maintenance, see
M21: Replacing the photometer lamp on page C-113
Roche Diagnostics
Monthly maintenance
a To reinstall reaction parts and to terminate the incubator bath cleaning

mode
1 Place all segments of reaction cells (cleaned or new cells).
2 Return the cell rinse unit, the sipper cover and the cell covers.
4 Switch on the analytical unit and the control unit.
The incubator bath is filled with some water. A yellow alarm is issued, indicating
that the level of incubation water is below the lower limit.
5 Perform maintenance item (4) Incubation Water Exchange.
The incubator is exchanged and Hitergent (4.3 mL) is added.
6 Perform maintenance item (6) Wash Reaction Parts.
7 Perform maintenance item (3) Cell Blank Measurement to verify the integrity of
the reaction cells and to compensate for a potential change in light intensity after
the cleaning of the photometric windows.
e For detailed instructions, see:
To wash the reaction parts on page C-59
To perform a cell blank measurement on page C-60
Roche Diagnostics
Monthly maintenance
M9: Cleaning the ISE Ref. aspiration filter
Inspect the ISE Ref. aspiration filter, which is attached to the tube end in the ISE Ref.
bottle. Clean the filter each time you replace the ISE Ref. bottle but at least once a
month. Clogging of the filter will reduce the accuracy of ISE Ref. aspiration and data
reliability.
1. To clean the ISE Ref. aspiration filter
2. To reset the remaining volume of ISE Ref.
3. To prime the ISE Ref. tubing
Materials required m Paper towel

m Deionized water
a To clean the ISE Ref. aspiration filter

Roche Diagnostics
Monthly maintenance
Figure C-25 Cleaning the ISE Ref. aspiration filter
3 Remove the tubing from the ISE Ref. bottle and unscrew the filter from the tube
end.
4 Wash the filter with tap water.
5 Rinse the filter with deionized water.
6 Replace the ISE Ref. bottle if necessary.
7 Finally, screw the filter on the tube end and place it back into the bottle.
if it was in Shutdown status).The analyzer returns to Standby.
home positions.
11 If you have replaced the ISE Ref. bottle, reset the remaining volume.
e See: To reset the remaining volume of ISE Ref. on page C-75
Roche Diagnostics
Monthly maintenance
a To reset the remaining volume of ISE Ref.

1 Choose Reagent > Setting.
2 Select REF in the Type column.
The line ISE REF is highlighted.
3 Choose Reagent Level Reset button.
4 A confirmation window opens; choose Yes.
After reset, an initial value of 279 ml is displayed in the column Available Tests.
a To prime the ISE Ref. tubing

When the ISE Ref. aspiration filter was cleaned or the ISE Ref. bottle was replaced, air
may have entered into the ISE electrodes. So it is important to perform a reagent
prime for the ISE Ref. tubing.
e For information about the reagent consumption, see:
(7) Reagent Prime on page C-25
1 Choose Reagent > Setting.

2 Choose Reagent Prime to open the Reagent Prime window.
3 Choose Parameter to open the Reagent Parameter Setting window.
4 Select REF and choose OK.
The Reagent Prime window reappears.
5 Choose Execute.
The prime is complete when the system returns to Standby.
6 If you have replaced the ISE Ref. bottle, perform an ISE calibration before you
resume routine operation.
Roche Diagnostics
Monthly maintenance
M10: Cleaning the detergent aspiration filters
Inspect the detergent aspiration filters, which are attached to the tube end in the cell
detergent bottles. The cell detergent bottles (CellCln I and CellCln II) are located
behind the left front door. Clean the filter each time you replace a bottle but at least
once a month. Clogging of the filter will reduce the accuracy of detergent aspiration
and will lead to insufficient cell cleaning.
1. To clean the detergent aspiration filters
2. To reset the remaining volume
3. To perform a cell detergent prime
Materials required m Paper towel

m Deionized water
Roche Diagnostics
Monthly maintenance
a To clean the detergent aspiration filters

2 Open the left front door of the analyzer and take out the detergent bottle(s).
4
3
A Filter for CellCln I (with square end)

B Filter for CellCln II (with round end)
Figure C-26 Cleaning the detergent aspiration filters
3 Remove the tubing from the detergent bottle(s) and unscrew the filter from the
tube end.
CellCln I has a filter with a square end.

CellCln II has a filter with a round end.
4 Wash the filters with tap water.

5 Rinse the filters with deionized water.
Roche Diagnostics
Monthly maintenance
6 Screw the filter onto the tube end.
Incorrect results due to incorrect insertion of aspiration tube

If the aspiration tube is not inserted correctly, the detergent may not be dispensed
bottle.
7 Insert the tube back into the bottle.

8 If you have replaced a detergent bottle, it is necessary to reset the remaining
volume and to perform maintenance item (8) Cell Detergent Prime.
a To reset the remaining volume

1 If the analyzer was in Maintenance mode or shutdown:
o Ensure the top cover of the analyzer is locked.
o Turn the maintenance switch back to Operation mode (or power up the
analyzer if it was in Shutdown status).
home positions.
3 Choose Reagent > Status.
4 Select the detergent which you have replaced.
5 Choose Reagent Volume Reset and confirm with OK.
Cell wash I and II is reset.
Roche Diagnostics
Monthly maintenance
a To perform a cell detergent prime

After replacing a bottle, the detergent in the tubing is purged of air before starting
analysis.
2 Choose (8) Cell Detergent Prime on the Maintenance Items list on the right.
3 Choose Select to open the Cell Detergent Prime window.
Figure C-27 Cell Detergent Prime window
4 Select an option in the Detergent area to specify which line is to be primed:

Detergent 1 (CellCln I), Detergent 2 (CellCln II), or Detergent 1 & 2 (CellCln I
and II).
5 Choose Execute.
Roche Diagnostics
Monthly maintenance
M11: Cleaning the radiator filter
Clean the radiator filter of the cooling unit at least once a month to prevent dust or
dirt accumulation. Clogging of the filter may cause the analyzer to overheat.
Materials required m Vacuum cleaner

m Paper towels
m Water for rinsing
a To clean the radiator filter

2 Open the front doors.
3
5
Figure C-28 Cleaning the radiator filter
3 Vacuum the radiator filter and the radiator fins.

4 If there is a lot of particulate matter (i.e. dust), remove the filter by pulling it
forward from the retaining brackets.
5 Wash the filter with tap water and dry it completely with paper towels.
6 Reinstall the filter.
7 Close the front doors of the analyzer.
Roche Diagnostics
Monthly maintenance
M12: Checking and cleaning the water tank
Contamination inside the tank will result in contamination of the entire flow path
and adversely affect all measurements. Check the water tank at least once a month
and clean the tank if necessary.

m Paper towels
m Waste solution receptacle
m 0.5% sodium hypochlorite solution
m Deionized water
a To disconnect the water tank

1 Shut down the analyzer.

Cleaning of the water tank without turning off the power of the instrument allows the
WARNING deionized water supply unit to supply water during cleaning. Water supplied from the
deionized water supply unit may damage the instrument and lead to malfunction.
There is also a danger of electrical shock since there are some parts at high voltage
inside the analytical unit.
o Make sure that the analyzer is switched off before you continue.
o Do not reach into the analyzer without switching off power first.
2 Turn off the external water supply.

3 Open the left front door.
Roche Diagnostics
Monthly maintenance
A Closed tap
Figure C-29 Disconnecting the joint of the water tank
4 Close the tap at the outlet of the water tank.

5 Place a waste solution receptacle (or paper towels) under the hose unit to absorb
spilled water.
6 Separate the joint that connects the water tank and the water hose.
Roche Diagnostics
Monthly maintenance
Figure C-30 Removing the float assembly
7 Remove the float assembly from the tank while pulling out the tank and place the
float on a paper towel.
8 Visually check that the water is clear. If not, perform thorough cleaning.
e See: To thoroughly clean the water tank on page C-84
9 If the water is clear, empty the water from the tank and rinse it with deionized
water three times.
10 Fill the tank at least 1/3 full of deionized water.
11 Reconnect the water tank.
e See: To reconnect the water tank on page C-84
Roche Diagnostics
Monthly maintenance
a To thoroughly clean the water tank

1 Empty the water from the tank and rinse it thoroughly with 0.5% sodium
hypochlorite solution. For thorough cleaning use a brush to clean the interior
surface. Then wash with tap water to eliminate the sodium hypochlorite solution.
2 Rinse the tank thoroughly with deionized water three times.
3 Fill the tank at least 1/3 full of deionized water.
4 Reconnect the water tank.
e See: To reconnect the water tank on page C-84
a To reconnect the water tank

1 Wipe the float assembly with gauze pads moistened with deionized water.
2 Return the float assembly and place the tank back in its original position.
NOTICE Malfunction due to spilled liquid

If the joints of the water tank are not connected properly, water may leak and cause
damage to circuit boards.
Ensure that all joints are connected properly.
3 Reconnect the water hose to the water tank and open the tap (Figure C-29).
4 Close left front door.
5 Turn on the external water supply.
6 Ensure the top cover is locked, before you switch on the analyzer again.
Roche Diagnostics
Monthly maintenance
M13: Washing flow path of concentrated waste solution
The concentrated waste solution may be clogged if dirt or crystallizations accumulate

in the flow path. Wash the flow path with acidic detergent once a month.
Materials required m CellCln II (Acid Wash)
Roche Diagnostics
Monthly maintenance
a To wash the reaction system

2 Choose System Overview > Reagent Overview.
Figure C-31 Check the remaining amount of Cell Cleaner 2
3 Check the remaining amount of detergent. If insufficient, add a new detergent

bottle.
Detergent Detergent Position Consumption

Cell cleaner 2 CellCln II/Acid Wash Left front door approx. 30 mL
Table C-22 Detergent consumption
o If it is necessary to replace a detergent bottle:

e To replace a cell detergent bottle on page B-141
e To clean the detergent aspiration filters on page C-77

5 Choose Maintenance (1) on the Maintenance Types list on the left.
6 Choose (12) Flow Path Wash on the Maintenance Items list on the right.
7 Choose Select to open the Flow Path Wash window.
8 Choose Execute.
The flow path, the concentrated waste reservoir, and the drainage tube are
cleaned. The procedure is finished when the analyzer returns to Standby.
Roche Diagnostics
least once every two months.

precautions:
page A-9
M14: Replacing ISE measuring cartridges (Cl, K, Na)
The electrical response level and the slope value (sensitivity) of each measuring
cartridge slightly decrease with time and use. Replace an ISE measuring cartridge if
one of the following criteria is met:
o The cartridge has been in service more than 2 months.
o The test count has reached 9000 tests.
o The slope value of the cartridge falls outside of the normal range.
In the latter case, an alarm is issued as described in the figure below.
Na+, K+ Slop.E Prep.E (Normal range) Cond.E
+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV
Cl- Cond.E (Normal range) Prep.E Slop.E
- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV
Figure C-32 ISE data alarms and corresponding slope values (EMF values)
Judgement on ISE measuring cartridge replacement

o If the alarm “ISE slope marginal (Prep.E)” appears, you may continue the day’s analyses
but the cartridges must be replaced the next day. Check the QC to verify that the slope
is acceptable.
o If the alarm “ISE slope error (SlopeE)” appears, replace the cartridges at once.
o Normally, the slope values slightly decrease with time and use. If there is a large
change, the cause may be other than the electrodes. Check for air bubbles in or
leakage from the flow path, an error in substitution of standard solution, contamination
of the flow path, etc.

1. To replace ISE measuring cartridges
2. To prime lines
3. To perform an ISE Check and calibrate the ISE unit
Roche Diagnostics
System time: approximately 56 minutes (10 minutes for (7) Reagent Prime (IS+REF),
2*18 minutes for (2) ISE Check, plus 10 minutes in between)
Materials required m Sodium (Na+) cartridge

m Potassium (K+) cartridge
m Chloride (Cl-) cartridge
m Tweezers
m Reference solution ISE Ref.
m Internal standard ISE IS
a To replace ISE measuring cartridges

Figure C-33 Removing ISE covers and disconnecting electrode wires
3 Remove the sipper cover and the cover of the ISE measuring compartment.
4 Disconnect the three electrode wires (Cl, K and Na).
Roche Diagnostics
Figure C-34 Removing ISE cartridges and wiping up spilled liquid
5 Pull the release lever toward the RELEASE position to loosen the cartridges from
the mounting block. The lever is equipped with a spring—take care of your
fingers.
6 Use large tweezers to remove the cartridges from the mounting block.
7 During the replacement:
o Thoroughly wipe up any spilled liquid or liquid adhering to connecting parts.
Remaining liquid on ion selective electrodes may lower measurement
precision.
o If an O-Ring from the cartridges remains inside the ISE measuring
compartment, use tweezers to remove it.
8 Insert the new cartridges in the right color-coded position into the ISE measuring
compartment while holding the lever at RELEASE.
Verify that the connecting part and the new cartridges are provided with O-rings, but
be sure to remove the black rubber protectors that are located over the O-ring
receptacles on the cartridges.
9 Set the lever at LOCK to fasten the cartridges, then reconnect the four color-
coded electrode cords to their respective cartridges.
10 Replace the sipper cover and the cover of the ISE measuring compartment.

CAUTION reinstalled after maintenance, the temperature level or the noise level may be affected,
leading to incorrect results.
Always reinstall the covers of the ISE unit after performing maintenance.
Roche Diagnostics
a To prime lines
e For information about reagent consumption, see:

home positions.
6 Select (7) Reagent Prime from the Maintenance Items list on the right.
7 Choose Select to open the Reagent Prime window.
9 Choose IS+REF in the ISE area (or REF after replacement of the reference
cartridge) and OK.
The reagent prime is complete when the analyzer returns to Standby.
a To perform an ISE Check and calibrate the ISE unit

After installing new ISE cartridges, proceed with an ISE check to condition the
electrodes and then calibrate the ISE unit before you resume routine analysis.
2 Select Check (2) from the Maintenance Type list on the left.
3 Select (2) ISE Check from the Maintenance Items list on the right.
4 Choose Select, to open the ISE Check window.
5 Enter 10 at Cycles and choose Execute.
The electromotive force (EMF) values of the internal standard solution are
printed 10 times for each electrode. At this point, the results can be ignored.
Roche Diagnostics
6 After waiting ten minutes, execute another ISE check (10 cycles).
Make sure the printed EMF values of the internal standard solution are normal
and the difference in successive values for the same electrode are stable within
 0.2 mV. Otherwise retry ISE check.
Normal IS EMF values lie between NA: -10 to -90 mV, K -10 to -90 mV and Cl 80
to 160 mV, Ref -7 to 7 mV. The maximum deviation for Ref EMF over all values
should be no more than  2 mV.
If an EMF value is abnormal (level error or noise error for example), the
corresponding alarm name will be printed out.
e See ISE data alarms and corresponding slope values (EMF values) on page C-87.
ISE Check 07/07/31 10:46
NO NA EMF K EMF CL EMF REF EMF

1 -65.2 -71.5 102.7 0.2
2 -65.2 -71.6 102.8 0.2
3 -65.1 -71.7 102.8 0.2
4 -65.0 -71.8 102.9 0.3
5 -65.0 -72.0 103.1 0.2
6 -64.9 -72.0 103.2 0.3
7 -64.8 -72.1 103.4 0.3
8 -64.7 -72.1 103.6 0.2
9 -64.6 -72.1 103.7 0.1
10 -64.5 -72.1 103.8 0.0
Figure C-35 ISE Check report
7 Calibrate the ISE unit according to the procedure described.

Roche Diagnostics
least once every three months.

precautions:
page A-9

M15: Cleaning the ultrasonic mixer on page C-93
M16: Replacing the ISE pinch valve tubing on page C-96
M17: Replacing the ISE sipper tubing on page C-98
M18: Replacing the syringe seals on page C-101
Roche Diagnostics
M15: Cleaning the ultrasonic mixer
Clean the ultrasonic mixer at least once every three months. Contamination and
precipitation on the surface of the ultrasonic mixer may cause inadequate mixing and
thus lead to inaccurate results.
Replacement of ultrasonic mixer

The ultrasonic output intensity is continually monitored during measurement. If the data
alarm <MIX occurs frequently, the ultrasonic mixer needs to be replaced. Contact your
service representative for a replacement.
This maintenance action can be combined with the monthly maintenance action M8:
Replacing reaction cells and cleaning incubator bath and drain filter on page C-68.

1. To clean the surface of the ultrasonic mixer
2. To check the intensity of the ultrasonic output
Materials required m Cotton swabs

m Paper towels
m Hitergent cassette (surfactant for the incubator, consumption 4.3 mL)
m 2% Hitergent solution
m Deionized water

precautions:
a To clean the surface of the ultrasonic mixer

1 Choose System Overview > Reagent Overview screen.
2 Check the remaining amount of Hitergent. If insufficient, add a new cobas c pack.
3 Put the analyzer in incubator bath cleaning mode.
To put the analyzer in incubator bath cleaning mode:
o Choose Utility > Maintenance.
o Select Maintenance (1) from the Maintenance Type list on the left.
o Select (9) Incubator Bath Cleaning from the Maintenance Items list on the
right.
o Choose Select to open the Incubator Bath Cleaning window.
o Choose Execute. The water is drained from the incubator bath and the control
unit is powered off.
4 After the computer power supply has powered off, switch off power for the
analytical unit.
Do not open the top cover of the analyzer until the analyzer is in shutdown.
Roche Diagnostics
6/7
A
A Polished surfaces of the ultrasonic mixer
Figure C-36 Cleaning the surfaces of the ultrasonic mixer with cotton swabs
6 Remove the cell cover attached to the ultrasonic mixer.

7 Remove the segment of reaction cells near the ultrasonic mixer. Be careful not to
touch the surfaces of the reaction cells.
8 Gently wipe the polished surfaces of the ultrasonic mixer (A) with a cotton swab
moistened with 2% Hitergent solution. Then, wipe off the detergent with a cotton
swab moistened with deionized water.
9 Put the reaction cells back in place. In case you are re-using used reaction cells, be
sure to put them back in their previous positions.
10 Return the cell cover.
Roche Diagnostics
12 Switch on the analytical unit and the control unit.

The incubator bath is filled with some water. A yellow alarm is issued, indicating
that the level of incubation water is below the lower limit.
13 Perform maintenance item (4) Incubation Water Exchange.
The incubator is filled up completely and Hitergent (4.3 mL) is added.
a To check the intensity of the ultrasonic output

3 Select (6) Cuvette Mixing from the Maintenance Items list on the right.
4 Choose Select to open the Cuvette Mixing window.
5 Enter 10 in the Cycles text box and choose Execute.
In case an alarm occurs, follow the remedies described in the alarm message.
In case you are also performing monthly maintenance action M8: Replacing reaction
cells and cleaning incubator bath and drain filter, continue with Step 6 of To reinstall
reaction parts and to terminate the incubator bath cleaning mode on page C-72.
In case you also want to perform every six months maintenance action M21:
Replacing the photometer lamp, continue with M21: Replacing the photometer lamp
on page C-113.
Roche Diagnostics
M16: Replacing the ISE pinch valve tubing
After long use, the tubing will gradually wear out and the accuracy of sample
aspiration will decrease. Replace the ISE pinch valve tubing once every three months.
System time: approximately 46 minutes (2*18 minutes for (2) ISE Check, plus
10 minutes in between)
Materials required m Pinch valve tubing
a To replace the ISE pinch valve tubing

A Pinch valve
Figure C-37 Replacing the ISE pinch valve tubing
Roche Diagnostics
4 Gently remove both ends of the ISE pinch valve tubing from their tube connectors
and pull the tubing through the pinch valve (A). Discard the old tubing.
5 Insert the new tubing through the pinch valve and attach both ends of the tubing
to the connectors. Make sure that there is no slack in the tubing.
In case you also want to replace the ISE sipper tubing, continue with Step 4 of
M17: Replacing the ISE sipper tubing on page C-98. Perform the ISE Check
afterwards.

home positions.
10 Perform maintenance check (2) ISE Check (10 cycles) to condition the electrodes.
11 After waiting 10 minutes, perform maintenance check (2) ISE Check (10 cycles)
again. Check the printed EMF values. Then calibrate the ISE unit before you
resume routine analysis.
Roche Diagnostics
M17: Replacing the ISE sipper tubing
After long use, the tubing will gradually wear out and the accuracy of sample
aspiration will decrease. Replace the ISE sipper tubing once every three months.
System time: approximately 46 minutes (2*18 minutes for (2) ISE Check, plus
10 minutes in between)
Materials required m ISE sipper tubing
Roche Diagnostics
a To replace the ISE sipper tubing

A Arm cover of the sipper nozzle
Figure C-38 Replacing the ISE sipper tubing
3 Remove the sipper cover, the arm cover of the sipper nozzle, and the cover of the
ISE measuring compartment.
4 Gently remove both ends of the ISE sipper tubing from the tube connectors.
Discard the old tubing.
Roche Diagnostics
5 Attach both ends of the new tubing to the tube connectors.

In case you also want to replace the ISE pinch valve tubing, continue with Step 4
of M16: Replacing the ISE pinch valve tubing on page C-96.

6 Replace the arm cover of the sipper nozzle, the cover of the ISE measuring
compartment, and the sipper cover.
home positions.
10 Perform maintenance check (2) ISE Check (10 cycles) to condition the
electrodes.
11 After waiting 10 minutes, perform maintenance check (2) ISE Check (10 cycles)
again. Check the printed EMF values. Then calibrate the ISE unit before you
resume routine analysis.
Roche Diagnostics
M18: Replacing the syringe seals
Replace the syringe seals every three months or after 112,500 samples for the reagent
and sample syringe or after 56,250 samples for the ISE sipper syringe. Worn-out
syringe seals can cause leakage and inaccurate pipetting.
There are three syringes behind the left front door of the cobas c 311 analyzer
(Figure C-39). The procedure for replacing the syringe seals is the same for all
syringes. Note, however, that there are different spare parts for each of the three
syringe types (sample, reagent, and ISE sipper syringe).
o The reagent syringe is used as an example in the rest of this section. All illustrations
show the reagent syringe.
o We recommend completing the procedures for the first syringe before starting with the
next. Do not dismount more than one syringe at the same time because the internal
parts of the syringes differ and may be mistaken easily with each other.

precautions:
WARNING o Infection by samples and associated materials on page A-8
A
B

B Sample syringe
Figure C-39 Syringe positions
Roche Diagnostics

1. To remove the syringe
2. To replace the syringe seals
3. To reattach the syringe
4. To perform an air purge (sample syringe or reagent syringe)
5. To perform a reagent prime (ISE sipper syringe)
6. To check syringe connections
Materials required m Seals

m Spanner wrench
m Deionized water
Roche Diagnostics
a To remove the syringe

2 Open the left front door of the analyzer and locate the syringes.
3 4 5
A
B
C
D
B
A Tube connectors B Syringe holder C Syringe

D Thread of the syringe holder
Figure C-40 Removing the syringes
3 To disconnect the tubing at the top and bottom of the syringe, loosen and remove
the upper and lower tube connectors (A). Use a dry gauze pad to absorb any liquid
leaking from the tubing or syringe.
4 Loosen the syringe holder (B) and lift it up about 1 cm (lift it up over the
thread (D) of the syringe holder).
5 Remove the syringe (C) by carefully pulling it toward you.
6 Place the removed syringe on a dry gauze pad.
NOTICE Damage to the syringe tubes by alcohol, grease or detergent.

Alcohol, grease or detergent that adheres to the syringe tubes may damage the tubes.
Avoid to apply alcohol, grease or detergent to the syringe tubes.
Roche Diagnostics
a To replace the syringe seals
D
H
A Spanner wrench C Upper seal piece F Spring

B Syringe barrel D Spacer G Retaining screw
E Lower seal piece H Plunger
Figure C-41 Replacing the syringe seals
1 Loosen the retaining screw (G) with the spanner wrench (A). Be careful not to
bend the plunger.
2 Carefully remove the plunger (H) together with the retaining screw (G) and the
syringe seals (C, E) from the syringe barrel.
Roche Diagnostics
Reagent syringe Sample syringe ISE sipper syringe
I
E
G
I
A Spanner wrench (see Figure C-41) F Spring

B Syringe barrel (see Figure C-41) G Retaining screw
C Upper seal piece H Plunger
D Spacer I Grooves of ISE sipper seals
E Lower seal piece
Figure C-42 Mounting order of syringe parts
3 Remove the upper seal piece (C), spacer (D), and lower seal piece (E) from the
plunger (H).
4 If the plunger, syringe or spacer are contaminated, wipe them with a gauze pad or
cotton swab moistened with deionized water.
5 Mount the retaining screw, spring, new lower seal piece, spacer, and new upper
seal piece onto the plunger as shown in Figure C-42.
o Be careful not to mistake the orientation of syringe seals and spacer!

o The seals are different in shape for each of the three types of syringe. Check the
part numbers that you have the correct seal before mounting.
NOTICE Damage to the syringe seals

Do not overtighten the retaining screw. If the retaining screw is overtightened, the
syringe seals wear out quickly and the plunger may bend or break, requiring
replacement.
Roche Diagnostics
6 Place the plunger (H) in the syringe barrel (B). Check that the spring (F) is
centered on the lower seal piece (E). If the spring is not centered, it could be
damaged during tightening.
7 Tighten the retaining screw with the spanner wrench.
a To reattach the syringe

1 To reattach the syringe, follow the instructions for removing in the reverse order.
e To remove the syringe on page C-103
2 Finally, it is important to check the connections. To do this you must first

perform either maintenance item (5) Air Purge or (7) Reagent Prime.
o If you are working on the ISE sipper syringe, perform maintenance item
(7) Reagent Prime and select IS+REF.
e For detailed instructions, see To perform a reagent prime (ISE sipper syringe) on
page C-107.
o If you are working on the sample syringe or the reagent syringe, perform an
air purge following the instructions below:
a To perform an air purge (sample syringe or reagent syringe)

4 Select (5) Air Purge from the Maintenance Items list on the right.
5 Choose Select to open the Air Purge window.
AU = Analytical Unit (refers to the photometric unit here)
Figure C-43 Air Purge window
6 Choose the syringe to be purged of air in the Syringe area and choose Execute.
The respective pipetter will operate. At the rinse station, water as well as any air
are discharged from the probe.
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7 After air purge, check connections following the instructions below.

e See To check syringe connections on page C-108.
8 Repeat steps 2-7 for other syringe.
a To perform a reagent prime (ISE sipper syringe)

e For information about the reagent consumption, see:
4 Select (7) Reagent Prime from the Maintenance Items list on the right.
5 Choose Select to open the Reagent Prime window.
7 Choose IS+REF in the ISE area and OK.
9 After reagent prime, check connections following the instructions below.
Roche Diagnostics
a To check syringe connections

1 After the reagent prime or air purge (in Standby mode), open the front door.
2 Check the following conditions:
o There is no leakage from any of the connections (see Figure C-44).
o There are no air bubbles in the syringe barrel (see Figure C-44).
Incorrect results due to loose tube connectors

A loose tube connector may cause insufficient pipetting and result in inaccurate
CAUTION measurement.
o Tighten the tube connector securely and make sure there is no liquid leakage.
o Observe the system safety labels illustrated from page A-16 to A-19 and in
particular the following: F-2.
A Check for leakage B Check for air bubbles
Figure C-44 Checking syringe for leakage and air bubbles
Roche Diagnostics
3 Inspect the syringe to ensure that no air remains in the syringe and no leaks are
visible at any of the fittings.
o If leakage is found at the syringe holder or tube connector, try to tighten.
o If leakage is found at the bottom of the syringe, try to attach again.
o If there are any air bubbles visible in the syringe, remove them by lightly
tapping your finger against the syringe while the liquid is flowing.
If bubbles cannot be removed, disconnect the syringe again (see To remove the syringe
on page C-103). Then wipe the plunger with gauze moistened with deionized water
(see To replace the syringe seals on page C-104).
4 Close the front door.
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least once every six months.

precautions:
page A-9

M19: Cleaning the inlet water filter on page C-110
M20: Cleaning the cooling fan on page C-112
M21: Replacing the photometer lamp on page C-113
M22: Replacing the ISE reference cartridge on page C-119
M19: Cleaning the inlet water filter
Clean the inlet water filter at least once every six months to prevent clogging of the
water system.
Materials required m Water pump filter (in case replacement is required)

m Paper towels
m Beaker or container, 500 mL
m Deionized water
Incorrect results due to loose water filter cap

If the water supply filter is clogged or the inlet water hose is not reconnected to the inlet
CAUTION water manifold correctly, it may cause instrument malfunction and result in inaccurate
measurement.
o Clean the filter regularly.
o Reconnect the inlet water hose to the inlet water manifold correctly.
the following: R-2.
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a To clean the inlet water filter

1 Turn off the external water supply.
2 Shut down the analyzer.
A Inlet water filter
Figure C-45 Cleaning the inlet water filter
3 Hold the hose up when it is disconnected to prevent spilling of water.

Or: Place a 500 mL beaker (or similarly appropriate container) beneath the inlet
water manifold.
4 Turn the ring on the water filter cap counterclockwise and disconnect the inlet
water hose.
5 Remove the water filter and place the hose in the container. Be careful not to
overturn the container.
6 Clean the filter thoroughly with deionized water, then reinstall the filter.
After cleaning, tighten the filter cap securely and make sure there is no water leakage.
7 Reconnect the inlet water hose to the inlet water manifold.

8 Turn on the external water supply.
Roche Diagnostics
M20: Cleaning the cooling fan
Clean the cooling fan at the rear of the analyzer to remove dust and dirt.
Materials required m Vacuum cleaner
a To clean the cooling fan
Personal injury through touching the fan

There is a grill to protect the operator from coming into contact with the moving fan. Do
WARNING not insert your fingers in the openings of the ventilation grill. If the fan is cleaned when the
analyzer is not in Shutdown status, there is a danger of injury.
Therefore shut down the analyzer before cleaning.
Figure C-46 Cleaning the cooling fan
1 Make sure that the analyzer is in Shutdown status.

2 Vacuum dust, dirt, and other debris from the cooling fan at the back of the
analyzer.
maintenance action in Shutdown status).
Roche Diagnostics
M21: Replacing the photometer lamp
The reproducibility of measurement will decrease if the photometer lamp

deteriorates. Replace the photometer lamp if the lamp has been used for more than
six months (or 750 hours(a)) or if the photometer check value exceeds 14000.
We recommend combining this maintenance action with the monthly cleaning of the
incubator bath and with the quarterly cleaning of the ultrasonic mixer.
1. To check the light intensity
2. To remove the photometer lamp
3. To install a new photometer lamp
4. To perform a cell blank measurement

m Photometer lamp
a To check the light intensity

We recommend checking the light intensity daily to maintain reproducibility of
measurement. The photometer check can be included in a Start Up or Power ON
pipe.
3 Select (2) Photometer Check from the Maintenance Items list on the right.
4 Choose Select to open the Photometer Check window.
5 Select Execute.
Water is injected from the rinsing mechanism into reaction cell no. 1 and the
absorbance of the water is measured for each available wavelength.
6 After the photometer check, select Print (global button) to open the Print
window.
7 Select Print (or View) > Utility > Photometer Check to check the absorbance
values of the current photometer check.
(a) This is Power On Time, i.e. the time the analyzer is ON. You can check the Power on time of the
analyzer by looking at the printed Maintenance Report (Print > Utility > Maintenance Report).
Roche Diagnostics
Photometer Check 8:20

---------------PREVIOUS DATA--------------- ---------------CURRENT DATA---------------
c311 DATE 07/08/1 8:20 DATE 07/08/2 8:18
340 nm 10386 340 nm 10386
376 nm 10358 376 nm 10358
415 nm 9534 415 nm 9534
450 nm 9275 450 nm 9275
480 nm 9195 480 nm 9195
505 nm 9130 505 nm 9130
546 nm 8984 546 nm 8984
570 nm 8967 570 nm 8967
600 nm 8929 600 nm 8929
660 nm 8676 660 nm 8676
700 nm 8657 700 nm 8657
800 nm 8594 800 nm 8594
Figure C-47 Photometer check report
If the current readings exceed 14000 at any wavelength, check the following points
and then replace the photometer lamp:
o Verify that the reaction cells, the incubator bath, and the photometric windows
are free of contamination or bubbles.
o Verify that the reaction cells are not scratched or cracked.
o Verify that reaction cell no. 1 is at least half filled with water.
If the current data value is quite different from the previous one, check if one of the
above applies.
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Burns due to hot surface!

You may burn yourself if you touch any part of the photometer lamp unit.
WARNING o Wait about 30 minutes after turning off lamp power.
o Check that the photometer lamp unit has cooled down before replacing the lamp.
the following: T-1.

precautions:
a To remove the photometer lamp

1 Shut down the analyzer. This is necessary to switch off power for the photometer
lamp.
2 Wait about 30 minutes for the lamp and lamp housing to cool down.
Figure C-48 Removing the reaction disk
4 Remove cell rinse unit, sipper cover and cell covers.

5 Remove each segment of reaction cells from the reaction disk. Be careful not to
touch the surfaces of the reaction cells.
If the reaction disk is detached with the reaction cells left in place, water drops
adhering to the outside of the reaction cells may drip onto the space surrounding the
photometer lamp. This may cause an alarm to be issued.
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6 Loosen the three retaining screws and remove the reaction disk from the system.
A Connector cover
Figure C-49 Removing the photometer lamp
7 Rotate the connector cover (A) counterclockwise and disconnect the connector of
the lamp wire.
8 Loosen the two lamp retaining screws and take out the photometer lamp.
When the screws become loose and turn easily, the lamp can be detached.
9 Carefully remove the retaining screws from the lamp base. These are needed to
install the new lamp.
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a To install a new photometer lamp
2/3
Figure C-50 Installing a new photometer lamp
1 Insert the retaining screws in the new lamp.

2 Insert the new photometer lamp.
3 Align the pin hole in the lamp base with the guide pin of the lamp housing and
tighten the two lamp retaining screws.
Be careful not to touch the glass part of the new photometer lamp. If you do touch the
glass, wipe it off with a gauze pad.
4 Connect the connectors of the lamp wires.

Secure the lamp wires by wrapping them around the plastic retaining hook.
5 Reinstall the reaction disk and reaction cells and put the cell covers and sipper
cover back in place.
6 Return the cell rinse unit to its original position.
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maintenance action in Shutdown status).
8 Switch on the analyzer again.
9 Wait 30 minutes for the photometer lamp to stabilize and perform a cell blank
measurement before you resume routine operation. This is necessary to
compensate for a potential change in light intensity.
e For instructions, see To perform a cell blank measurement on page C-60.
In case you are also performing the monthly maintenance action M8: Replacing
reaction cells and cleaning incubator bath and drain filter, continue with Step 6 of
To reinstall reaction parts and to terminate the incubator bath cleaning mode on
page C-72. This includes a cell blank measurement.
Roche Diagnostics
M22: Replacing the ISE reference cartridge
Like any ISE cartridge, the ISE reference cartridge slowly deteriorates with use over
time. Eventually, the electromotive force (EMF) values of all cartridges may become
unstable. Therefore, replace the reference cartridge every six months.
1. To replace the ISE reference cartridge
2. To prime lines
3. To perform an ISE Check and calibrate the ISE unit
System time: approximately 48 minutes (2 minutes for (7) Reagent Prime (REF),
2*18 minutes for (2) ISE Check, plus 10 minutes in between)
Materials required m ISE reference cartridge

m Tweezers
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a To replace the ISE reference cartridge

e
4
3
Figure C-51 Removing ISE covers and disconnecting the reference electrode wire
4 Disconnect the electrode wire of the ISE reference cartridge.
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6
7
Figure C-52 Removing the ISE reference cartridge and wiping up spilled liquid
5 Pull the release lever toward the RELEASE position to loosen the cartridges from
the mounting block.
6 Use tweezers to remove the reference cartridge from the mounting block.
7 During the replacement:
o Thoroughly wipe up any spilled liquid or liquid adhering to connecting parts.
Remaining liquid on ion selective electrodes may lower measurement
precision.
o If an O-Ring from the cartridges is remaining inside the ISE measuring
compartment, use tweezers to remove it.
8 Insert the new ISE reference cartridge into the ISE measuring compartment while
holding the lever at RELEASE.
Verify that the connecting part and the new cartridge is provided with O-rings, but be
sure to remove the black rubber protectors that are located over the O-ring receptacles
on the cartridge.
9 Set the lever at LOCK to fasten the cartridge, then reconnect the wire to the
cartridge.

11 Go through the following procedures before you resume routine operation. Select
the REF option for the reagent prime.
e See: To prime lines on page C-90
To perform an ISE Check and calibrate the ISE unit on page C-90
Roche Diagnostics
In this section you will find all the maintenance actions that must be performed as
needed and are not subject to a regular time schedule.
M23: Replacing sample and reagent probes—elimination of clogging on page C-122
M24: Replacing nozzle tips on cell rinse nozzles on page C-131
M25: Draining the vacuum tank on page C-133
M23: Replacing sample and reagent probes—elimination of clogging
It is necessary to remove a probe to clean its inside, eliminate clogging, as well as for
replacement. Replace the sample, ISE or reagent probes when they are bent or
otherwise damaged.
1. To wash the sample probe
2. To remove the sample probe
3. To remove the reagent probe
4. To eliminate clogging
5. To put back the sample probe
6. To put back the reagent probe
7. To check the tubing system for leakage
8. To perform an air purge and check the operation of the probe
9. To perform a Mechanisms Check
Materials required m Sample Cleaner 1 (SmpCln 1): approximately 300 L (in case the sample probe is
to be washed)
m Sample or reagent probe (in case replacement is required)
m Sample probe seal (in case it has been pulled-off and the probe is not replaced)
m Cleaning wire (stainless steel) of 0.2 and 0.5 mm diameter
m Deionized water
Roche Diagnostics
Before performing these maintenance actions, observe the following safety

precautions:
page A-9
a To wash the sample probe

This procedure can be used to wash a clogged sample probe.
1 Put the analyzer in Standby.
4 Select (11) Sample Probe Wash from the Maintenance Items list on the right.
5 Choose Select to open the Sample Probe Wash window.
6 Specify a number of cycles for washing in the Cycles input box (5 cycles are
recommended).
7 Choose Execute.
The inside of the sample probe is cleaned with Sample Cleaner 1 (SmpCln 1).
Roche Diagnostics
a To remove the sample probe

1 Shut down the analyzer. (In Maintenance mode, the liquid level sensor would be
electrified.)
5
4
A Probe seal
Figure C-53 Removing the sample probe
3 Remove the pipetter arm cover by pressing the arm cover releases—located on
either side of the fixed bottom part of the pipetter arm—and gently lift up the
cover. This exposes the wires and the tubing.
4 Disconnect the wire of the liquid level sensor.
5 Loosen the tubing from the probe by unscrewing it, taking care not to drop and
lose the probe seal (A). Check that the probe seal stays either on the end of the
probe tubing or in the retaining nut.
6 Lift the probe from the probe arm.
Roche Diagnostics
a To remove the reagent probe
Figure C-54 Removing the reagent probe
1 Disconnect the tube connector of the reagent tubing.

2 Loosen the probe retaining nut by turning it counterclockwise.
3 Lift the probe from the probe arm.
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a To eliminate clogging
Sample probe Reagent probe
Figure C-55 Eliminate clogging from the probes
1 To eliminate clogging use probe cleaning wire (stainless steel) with the following
diameters:
o For the sample probe: 0.2 mm diameter
o For the reagent probe: 0.5 mm diameter
2 Insert the probe cleaning wire into the probe tip and run it through the probe.
Roche Diagnostics
a To put back the sample probe

1 To put the sample probe back in place, follow the instructions in the note below
and the instructions for removing in the reverse order.
Observe the following when replacing the sample probe:

o When replacing the probe into the pipetter arm, the tab (Figure C-56, C) must slide
into the holding slot on the pipetter arm to ensure proper alignment.
o Make sure that the tubing is inserted and held in the slit of the foam cushion (A).
o A probe seal (B), once pulled off, should not be reused since the edge will be
deformed. A new probe always comes with a new seal.
o Reconnect the tubing making sure the probe seal is in place.
o Do not replace the arm cover of the probes until the tubing has been checked for
leakage.
e For the instructions for removing, see:

To remove the sample probe on page C-124.
A B C
A Foam cushion with holding slit for tubing C Tab for aligning the pipetter in the
B Probe seal pipetter arm
Figure C-56 Putting back the sample probe
2 Check the tubing system for leakage.

e See To check the tubing system for leakage on page C-128
Roche Diagnostics
a To put back the reagent probe

1 To put the reagent probe back in place, follow the instructions for removing in the
reverse order.
e To remove the reagent probe on page C-125
2 Check the tubing system for leakage.

e See To check the tubing system for leakage on page C-128
a To check the tubing system for leakage

2 Switch on the analyzer.
3 After initialization, put the analyzer in Maintenance mode.
5 Check the tubing joints of the probes for leakage.
o Sample pipetter
O Visually check for any water leakage from the connecting parts (while arm
cover is detached).
o Reagent pipetter
O Visually check for any water leakage from the connecting parts.
6 If there is a leak, perform the following:
o Close the top cover and turn the maintenance switch back to Operation mode.
o Shut down the analyzer temporarily.
o Wipe up the leaked water.
o Check for the cause and eliminate any leaks.
o Repeat steps 1-5 to check for leakages again.
7 If there are no leaks, perform the following:
o Replace the arm cover of the sample pipetter, the rear part first and then the
front part.
o Close the top cover of the analyzer and lock it.
home positions.
10 Go through the following procedures before you resume routine operation:
o To perform an air purge and check the operation of the probe
e To perform an air purge and check the operation of the probe on page C-129
o To perform a Mechanisms Check
e To perform a Mechanisms Check on page C-130
Roche Diagnostics
a To perform an air purge and check the operation of the probe

4 Select (5) Air Purge from the Maintenance Items list on the right.
5 Choose Select to open the Air Purge window.
Figure C-57 Air Purge window
6 In the Syringe area select the appropriate option (Sample Syringe, Reagent
Syringe or All).
7 Choose Execute to initiate the air purge.
The respective pipetter will operate (System time: 1:45). At the rinse station, water
as well as any air which may have become trapped are discharged.
8 With top cover closed, visually check that water is dispensed from the tip of the
probe in a straight flow.
If water is not dispensed in a straight flow, eliminate clogging of the probe.
M23: Replacing sample and reagent probes—elimination of clogging on page C-122.
Now, continue with the mechanisms check.
Roche Diagnostics
a To perform a Mechanisms Check

4 Select (3) Mechanisms Check from the Maintenance Items list on the right.
5 Choose Select to open the Mechanisms Check window.
Figure C-58 Mechanisms check window
6 Enter 30 at Cycles and choose Execute.

All mechanisms of the analyzer selected will operate (system time: 9:40).
After mechanisms check, the analyzer returns to Standby. If an error is detected, an

alarm will be issued.
Roche Diagnostics
M24: Replacing nozzle tips on cell rinse nozzles
Replace the nozzle tips on the cell rinse nozzles if they are worn. The replacement
cycle is typically one to two years depending on conditions of use.
Replace a nozzle tip if its corner or bottom is worn so that water remains in the
reaction cell.
Materials required m Nozzle tips

m Radio pliers

precautions:
a To replace the cell rinse nozzle tips

Figure C-59 Dismounting the cell rinse unit and the nozzle tips
3 Loosen the retaining screw of the cell rinse unit and lift off the entire unit.
Roche Diagnostics
4 Grip the nozzle tip with radio pliers and pull it off.
A Correct alignment Incorrect alignment
7
A
A Guide bar
Figure C-60 Alignment of a nozzle tip in relation to reaction cells
5 Attach a new nozzle tip by hand and align it with the guide bars (A).
6 Attach the cell rinse unit.
7 Make sure that the new nozzle tip is correctly aligned with the reaction cell.
home positions.
11 Perform maintenance check (3) Mechanisms Check (30 cycles).
e See To perform a Mechanisms Check on page C-130.
Roche Diagnostics
M25: Draining the vacuum tank
At the end of analysis each day, we recommend checking the vacuum tank. An alarm
will be issued (Liquid in vacuum tank) when there is water or waste solution in the
vacuum tank. If this alarm appears, the vacuum tank must be drained. If this happens
frequently, contact your local service representative.
Materials required m Beaker

precautions:
page A-10
a To drain the vacuum tank

2 Open the front doors of the analyzer and locate the vacuum tank.
Figure C-61 Draining the vacuum tank
3 Remove the cap holding the drain tube of the vacuum tank.
4 Drain the waste solution into a beaker.
5 Reattach the cap to secure the drain tube.
Roche Diagnostics
M26: Cleaning instrument surfaces
Spills on the instrument surface could be biohazardous and may damage the surface.
Clean up all spills immediately. Use this procedure to ensure that all surfaces are
clean.
Materials required m Disposable cloth or paper towels

m Laboratory disinfectant (no bleach)

precautions:
page A-9
NOTICE Damage to instrument surfaces

Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
a To clean instrument surfaces

2 Remove all samples from the instrument.
3 Clean the instrument surfaces using a cloth or paper towel moistened with
disinfectant.
Clean up all spills immediately. Ensure that all surfaces are clean.
4 Check the cell covers for contamination. If necessary, clean the cell covers using a
gauze pad moistened with disinfectant.
This is the last page of Part C.
Roche Diagnostics
Troubleshooting D
15 Data alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

16 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-49
cobas c 311 analyzer 15 Data alarms
Table of contents
Data alarms
This chapter contains the data alarms generated by the cobas c 311 analyzer. In
addition to a description of the cause of each alarm and remedy, the analytical unit of
origin and automatic rerun conditions are described here.

Introduction ..................................................................................................................... D-7
Data alarm list .................................................................................................................. D-8
Data alarms (ISE unit) .................................................................................................. D-10
ADC.E ....................................................................................................................... D-10
Calc.? ......................................................................................................................... D-10
Cal.E (Sample flag) ................................................................................................. D-11
ClcT.E ....................................................................................................................... D-11
CmpT.? ..................................................................................................................... D-12
CmpT.E .................................................................................................................... D-12
Edited ........................................................................................................................ D-12
H (only on printouts) ............................................................................................. D-13
>Index ....................................................................................................................... D-13
ISE.E .......................................................................................................................... D-13
ISE.N ......................................................................................................................... D-14
L (only on printouts) .............................................................................................. D-15
<Mix .......................................................................................................................... D-15
Mix.E ......................................................................................................................... D-15
Over.E ....................................................................................................................... D-15
Reag.S ........................................................................................................................ D-16
>Rept / <Rept .......................................................................................................... D-16
Samp.S ...................................................................................................................... D-16
Samp.C ..................................................................................................................... D-17
>Test ......................................................................................................................... D-17
>Test / <Test ............................................................................................................ D-18
Roche Diagnostics
Operator’s Manual · Version 2.0 D-3
15 Data alarms cobas c 311 analyzer
Table of contents
Data alarms (photometric unit) .................................................................................. D-19

>Abs .......................................................................................................................... D-19
ADC.E ....................................................................................................................... D-20
Calc.? ......................................................................................................................... D-20
Cal.E (Sample flag) ................................................................................................. D-20
ClcT.E ....................................................................................................................... D-21
CmpT.? ..................................................................................................................... D-21
CmpT.E .................................................................................................................... D-21
>Cuvet ...................................................................................................................... D-22
Det.S .......................................................................................................................... D-23
Edited ........................................................................................................................ D-23
H (only on printouts) ............................................................................................. D-23
>Index ....................................................................................................................... D-23
>Kin .......................................................................................................................... D-24
>Lin ........................................................................................................................... D-24
L (only on printouts) .............................................................................................. D-24
Mix.E ......................................................................................................................... D-25
<Mix .......................................................................................................................... D-25
Over.E ....................................................................................................................... D-25
>Proz ......................................................................................................................... D-26
>React ....................................................................................................................... D-26
ReagEx ...................................................................................................................... D-26
>Rept / <Rept .......................................................................................................... D-27
Samp.? ....................................................................................................................... D-27
Samp.C ..................................................................................................................... D-27
Samp.S ...................................................................................................................... D-27
>Test / <Test ............................................................................................................ D-27
Alarms for calibrations ................................................................................................. D-28
Cal.E (Calib flag) ..................................................................................................... D-28
Cond.E ...................................................................................................................... D-29
Dup.E ........................................................................................................................ D-30
IStd.E ........................................................................................................................ D-31
Prep.E ....................................................................................................................... D-32
Rsp1.E ....................................................................................................................... D-33
Rsp2.E ....................................................................................................................... D-33
S1A.E ......................................................................................................................... D-34
SD.E .......................................................................................................................... D-34
Sens.E ........................................................................................................................ D-35
Slop.E ........................................................................................................................ D-36
Std.E (ISE) ................................................................................................................ D-37
Std.E (P) ................................................................................................................... D-38
Roche Diagnostics
D-4 Operator’s Manual · Version 2.0
Table of contents
Data alarms for controls ............................................................................................... D-39

Q3SD ......................................................................................................................... D-39
Q2.5SD ..................................................................................................................... D-40
R4SD ......................................................................................................................... D-40
S2-2Sa ....................................................................................................................... D-40
S2-2Sw ...................................................................................................................... D-41
S4-1Sa ....................................................................................................................... D-41
S4-1Sw ...................................................................................................................... D-42
S10Xa ........................................................................................................................ D-42
S10Xw ....................................................................................................................... D-42
Data problems without alarm ...................................................................................... D-43
Drift of result data ................................................................................................... D-43
Erroneous operation ............................................................................................... D-43
Poor reproducibility ............................................................................................... D-44
Result data at high level .......................................................................................... D-45
Result data at low level ........................................................................................... D-45
Trouble attributed to characteristics of reagent ................................................. D-45
Trouble with a test .................................................................................................. D-46
Rerun list ........................................................................................................................ D-47
Roche Diagnostics
Table of contents
Roche Diagnostics
Introduction
Introduction
If any abnormality occurs while the analyzer is switched on, the analyzer notifies the
operator of the potential problem by issuing an alarm. These alarms comprise data
alarms (referring to irregular measurement results or conditions) and instrument
alarms (referring to irregular system conditions). Alarms are classified into five levels:
Alarm levels Data alarm This alarm is attached to the results of calibrations or to measurement
results of QC or patient samples. If a data alarm occurs at calibration or
QC sample measurement and if it will affect subsequent measurements,
an instrument alarm of the warning level occurs at the same time. The
analyzer does not stop operation.
Warning This alarm is generated by data alarms or troubles on the instrument. If
this alarm occurs during operation, the analyzer does not stop operation.
The operator must judge whether to continue or interrupt measurement.
Sampling stop This alarm concerns troubles on the instrument. For the pipetted sample,
measurement is continued. The analyzer stops pipetting new samples.
Stop This alarm concerns troubles on the instrument. The analyzer stops
operation within one cycle (12 seconds). For the sample under
measurement, no result data are obtained and the measurement must be
repeated.
Emergency stop This alarm concerns troubles on the instrument. The analyzer
immediately stops operation. For the samples under measurement, no
result data are obtained and the measurement must be repeated.
Alarm indication Data alarms are indicated on the Workplace > Data Review screen, on the Test
Review window (Workplace > Data Review > Test Review), on printed reports, and
are sent to Host. If a data alarm occurs, a symbol (also referred to as flag) is attached
to the measurement result. These flags are strings of three to six characters, which are
all explained in this chapter.
Instrument alarms are indicated by the Alarm button (global button) on the System
Overview screen as well as by an audible alarm. If an alarm occurs, the Alarm button
flashes. Its color indicates the alarm level: Yellow indicates warning level, red
indicates sampling stop, stop, or emergency stop.
In case of an alarm choose the Alarm button to open the Alarm window. This
window provides an alarm list and descriptions and remedies for each listed alarm.
Automatic rerun If a data alarm occurs on a test for which automatic rerun is selected (check box on
Utility > Application > Range), a rerun is automatically requested. For execution of
the automatic rerun during measurement, however, automatic rerun needs to be
activated on the Start Conditions screen as well.
For QC and patient samples, a data alarm consists of an alarm message and a result
message. The result messages are specific to the cobas c 311 analyzer tests.
Roche Diagnostics
Data alarm list
Data alarm list
The following table displays the data alarms applicable to the ISE unit, the
photometric unit, and their presentation (flag) on screens and reports.
Flag Alarm ISE unit Photometric unit

>Abs ABS over – l
ADC.E ADC abnormal l l
Calc.? Calculation not possible l l
Cal.E (Sample flag) Calibration result abnormal (Sample flag) l l
ClcT.E Calculated test error l l
CmpT.? Unable to calculate compensated test l l
CmpT.E Data error in compensated test l l
>Cuvet Cell blank abnormal – l
Det.S Detergent short (carryover evasion) – l
Edited Edited test l l
H (only on the report) Outside of the upper expected value (a)
l l
>Index Serum index check l l
ISE.E ISE voltage level error l –
ISE.N ISE noise error l –
>Kin Prozone error 2 / Kinetic unstable – l
>Lin Linearity abnormal – l
L (only on the report) Outside of the lower expected value (a)
l l
Mix.E Ultrasonic mixing error l l
<Mix Mixing power low level l l
Over.E Overflow l l
>Proz Prozone error 1 – l
Q2.5SD 1-2.5SD (QC error 2) (b) l l
Q3SD 1-3SD (QC error 1) (b) l l
R4SD R-4S (Random error in realtime QC) (b) l l
>React Reaction limit over (substrate depletion) – l
ReagEx Reagent expired – l
Reag.S Reagent short l –
>Rept / <Rept Repeat limit over (upper / lower) l l
S2-2Sa 2-2SA (Syst. error 1 - 2 results) (b)
l l
S2-2Sw 2-2SW (Syst. error 2 - 2 samples / 4 results) (b)
l l
S4-1Sa 4-1SA (Syst. error 3 - 4 results) (b)
l l
S4-1Sw 4-1SW (Syst. error 4 - 4 samples / 8 results) (b)
l l
S10Xa 10XA (Syst. error 5 - 10 results) (b)
l l
S10Xw 10XW (Syst. error 6 - 10 samples / 20 results) (b)
l l
Samp.? ABS maximum over (non-lin curve) – l
Samp.C Sample clot l l
Table D-1 Data alarm list (Sheet 1 of 2)
(a) Only on printouts.
(b) QC alarms, see: Data alarms for controls on page D-39, Configuring and using realtime QC on page B-193.
Roche Diagnostics
Data alarm list

Samp.S Sample short l l
>Test ISE range over l –
>Test / <Test ISE sample range outside technical limit, l l
photometric unit: Upper/Lower technical Limit
Table D-1 Data alarm list (Sheet 2 of 2)
(a) Only on printouts.
(b) QC alarms, see: Data alarms for controls on page D-39, Configuring and using realtime QC on page B-193.
Roche Diagnostics
Data alarms (ISE unit)
ADC.E
Alarm ADC abnormal
Description The analog/digital converter does not work normally.
Cause Numerical conversion of the electromotive force is abnormal.
Remedy 1 If other instrument alarm exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance and perform maintenance item (1) Reset. If the
alarm recurs call technical support.
Calc.?
Alarm Calculation not possible
Description The denominator becomes zero in calculation.

1 During calculation the denominator became zero.
2 An overflow occurred in logarithmic or exponential calculation.
3 Result was left blank.
Cause Internal calculation error has occurred.
Roche Diagnostics
Remedy 1 Check the test that is flagged with an error message in the calculation. Dilute the
sample and rerun the sample.
2 Check the calibration type list box on Utility > Application > Calib.
3 Resume operation. If alarm recurs, call technical support.
Cal.E (Sample flag)
Alarm Calibration result abnormal (Sample flag)
Description No calibration data or previous calibration data used.
Cal.E appears on each QC and patient sample for the affected test until the problem is
resolved.
Cause Any alarm, for example, Std.E, ISE.E, ISE.N, …, occurred during calibration.
Remedy 1 Correct the condition causing the alarm that occurred during the latest
calibration.
2 Recalibrate.
ClcT.E
Alarm Calculated test error
Description Calculation error has occurred.
Cause A data alarm has occurred for a test needed in the calculation. This is not valid for the
following errors and alarms:
o Calculation not possible (Calc.?)
o Unable to calculate compensated test (CmpT.?)
Remedy 1 Correct the data alarm of the test to be used on the calculation.
2 Recalibrate.
Roche Diagnostics
CmpT.?
Alarm Unable to calculate compensated test
Description During test-to-test compensation calculation, the denominator became zero. Blank
space is left in the report.
Cause o The test used for test-to-test compensation has not been measured yet.
o Any test used for test-to-test compensation has data alarm calculation not
possible (Calc.?) or data error in compensated test (CmpT.E).
o Any test used in the compensation formula has a data alarm that leaves the result
blank (for example, Samp.S, Reag.S).
Remedy 1 Correct the data alarm of the test to be used for compensation.
2 Rerun the sample.
CmpT.E
Alarm Data error in compensated test
Description 1 In test-to-test compensation calculation, a data alarm other than those shown
below is indicated for the compensation test data.
2 Calculation not possible, test-to-test compensation disabled, overflow.
Cause The test to be used for compensation has a data alarm.
Remedy Correct the data alarm on the test to be used for compensation. Rerun the sample.
Edited
Alarm Edited test
Description An edited first result or replaced rerun result is marked with an Edited alarm on the
Data Review screen. This also prints on the patient report.
Cause The result data has been edited.
Remedy Check the result of measurement.
Roche Diagnostics
H (only on printouts)
Alarm Outside of the upper expected value
Description For patient samples, the calculated concentration is greater than the upper limit of
the expected value range.
For control samples, a concentration exceeded the 2 SD values specified on QC >
Install.
Cause o The sample concentration is higher than the expected value.

o A proper expected value range is not specified.
Remedy Follow laboratory protocol for high samples.
This alarm does NOT cause an incomplete sample status alarm.
>Index
Alarm Serum index check
Description In one or more tests, the L, H, I value is larger than the specified reference value
(Utility > Application > Range).
The serum index check is performed after all test results are generated. If a data alarm
is already attached to the result, no serum index check will be performed.
Cause A highly lipemic, hemolytic, or icteric sample has been measured.
ISE.E
Alarm ISE voltage level error
Description During measurement of internal reference, the EMF was not within the following
ranges (Internal standard solution):
Na+ -90.0 to -10 mV

+
K -90.0 to -10 mV
Cl- 80.0 to 160 mV
Cause o The reference electrode is deteriorated.

o Insulation is poor due to liquid leakage from the reference electrode mounting
section.
o The internal standard solution (ISE IS) is not set properly.
Roche Diagnostics
Remedy 1 Set the reagent and perform maintenance item (7) Reagent Prime for the ISE unit
(IS+REF).
2 Replace the electrode and perform maintenance item (7) Reagent Prime for the
ISE unit (IS+REF).
3 Make sure that the O-ring is attached to the electrode joint and then perform
maintenance item (7) Reagent Prime for the ISE unit (IS+REF).
4 Set the internal standard solution (ISE IS) properly and perform maintenance
item (7) Reagent Prime for the ISE unit (IS+REF).
5 Connect the cord correctly.
ISE.N
Alarm ISE noise error
Description In ISE measurement, the fluctuation in electromotive force exceeds the following
value:
Na+ 0.7 mV
K+ 1.0 mV
Cl- 0.8 mV
Cause o Entry of air bubbles because of lack of reagent

o Entry of air bubbles due to improper attachment of electrode
o Entry of air bubbles through sipper tube
o Poor insulation of waste solution drain port
o Poor insulation due to liquid leakage from sipper pipetter
o Missing covers of the ISE unit
Remedy 1 Check for sufficient reagent volume, make sure the tubing sits correctly in the
ISE Ref. bottle, and perform maintenance item (7) Reagent Prime for the ISE unit
(IS + REF).
2 Make sure that the O-ring is attached to the electrode joint and perform
maintenance item (7) Reagent Prime for the ISE unit (IS + REF).
3 Replace the sipper tube and perform maintenance item (7) Reagent Prime for the
ISE unit (IS + REF).
4 Eliminate deposits.
5 Carry out cleaning, checkup, and maintenance of the sipper syringe.
6 Make sure that the ISE compartment cover and the cover of the ISE sipper are
reinstalled after maintenance.
Roche Diagnostics
L (only on printouts)
Alarm Outside of the lower expected value
Description For patient samples, the calculated concentration is less than the lower limit of the
expected value range. For control samples, a concentration was less than the 2 SD
values entered on QC > Install.
Cause o The sample concentration is lower than the expected value.

o A proper expected value range is not specified.
Remedy Follow laboratory protocol for low samples.
This alarm does NOT cause an incomplete sample status alarm.
<Mix
Alarm Mixing power low level

e Cause and remedy are identical to the data alarm of the photometric unit.
See <Mix on page D-25.
Mix.E
Alarm Ultrasonic mixing error

e Cause and remedy are identical to the data alarm of the photometric unit.
See Mix.E on page D-25.
Over.E
Alarm Overflow
Description Display is not possible because the output figure exceeds 6 digits
Cause o The data is obtained in more than six digits including a negative sign and decimal
point.
Remedy o Minimize the difference in concentration between the sample and calibrator.
o Obtain the result data with six characters including negative sign and decimal
point.
Roche Diagnostics
Reag.S
Alarm Reagent short
Description There is insufficient ISE reagent volume when alarm is associated with sodium,
potassium and chloride values.
Cause There is not enough reagent in the reagent bottle.
Remedy 1 Verify adequate reagent volumes. Replace low reagent, as necessary. Update the
new reagent volume manually. Prime new reagent and recalibrate.
2 If adequate reagent volumes are present, verify volumes on the Reagent screen.
Update the values manually, if necessary. Rerun the sample.
>Rept / <Rept
Alarm Repeat limit over (upper / lower)
Description The result falls outside the repeat limit range programmed on Utility >
Application > Range.
Cause The sample concentration is higher (>Rept) or lower (<Rept) than the set value.
Remedy This alarm can be activated on Utility > System (Page 1/5) > Alarm. If activated, the
analyzer can also be programmed to automatically repeat this test with normal
sample volume.
Samp.S
Alarm Sample short
Description The liquid level cannot be detected in the sample container.
Cause 1 The sample volume is insufficient in the sample container.

2 The sample probe wire is disconnected.
Remedy 1 Add sample and rerun.

2 If alarm recurs, check sample probe alignment and sample probe wire
connections.
Roche Diagnostics
Samp.C
Alarm Sample clot
Description The specified volume of sample is not aspirated.
Cause A clot is detected.
Remedy 1 Perform maintenance procedure To wash the sample probe on page C-123.
2 If alarm recurs, remove the sample probe, clean it manually, and eliminate clog. If
a probe is bent or damaged, replace it with a new one.
e See M23: Replacing sample and reagent probes—elimination of clogging on page C-122
>Test
Alarm ISE range over
Description If the data is out of following ranges, ISE range over is issued.
Na+ 10-250 mmol/L

K+ 1-100 mmol/L
Cl- 10-250 mmol/L
Cause o The electrode is deteriorated.

o The flow path is contaminated.
Remedy 1 Are controls in range?

If Yes, go to 2.
If No, go to 3.
2 Continue with routine analysis. Continue with step 3 at the end of the day.
3 Replace the appropriate cartridge according to the procedure in the Maintenance
Guide.
e See M14: Replacing ISE measuring cartridges (Cl, K, Na) on page C-87.
4 Resume operation.
If alarm recurs, call technical support.
Roche Diagnostics
>Test / <Test
Alarm ISE sample range outside technical limit
Description The measured value is outside the technical limit range entered on Utility >
o Over the technical limit: Value is greater than the upper limit (>Test).
o Under the technical limit: Value is less than the lower limit (<Test).
Cause 1 The sample concentration is higher than the set value (>Test).
2 The sample concentration is lower than the set value (<Test).
3 An improper technical limit range is specified.
Remedy 1 Manually dilute and rerun the diluted sample until the measured concentration is
within the specified range. Be sure to calculate the original concentration from the
measured value, using the correct dilution factor.
In case of urine sample s with a <Test alarm, a manual rerun can be performed
with decreased volume (6.5 L instead of normal volume).
2 Perform maintenance item (11) Sample Probe Wash.
3 Clean the sample probe manually.
4 Call technical support.
Roche Diagnostics
Data alarms (photometric unit)
>Abs
Alarm ABS over
Description The absorbance value to be used for calculation after cell blank correction exceeded
3.3.
Cause o The sample concentration is too high or the sample is lipemic.

o The reagent has not been prepared properly.
o Obstructions are in the optical path of the photometer.
Remedy o If only one sample is affected: Check whether the sample is grossly lipemic or has
an extremely high value. Follow your laboratory protocol for this situation.
o If only one application is affected: Check reagent preparation for that test.
o If all samples are affected:
O Remove any obstructions in the optical path of the photometer. Make sure the
lamp is on.
O Choose Utility > Maintenance and perform maintenance item
(4) Incubation Water Exchange
O Clean the incubator bath if it is contaminated.
e For further instructions, see:
M8: Replacing reaction cells and cleaning incubator bath and drain filter on
page C-68.
O Choose Utility > Maintenance and perform maintenance item
(2) Photometer Check.
O Check the Photometer Check results on the printout (Abs < 14000).
O Replace the photometer lamp, if necessary.
O Resume operation. If alarm recurs, call technical support.
o If all samples are affected sporadically:
O Check if some reaction cells are scratched. Replace all cells if necessary.
M8: Replacing reaction cells and cleaning incubator bath and drain filter on
page C-68
Roche Diagnostics
ADC.E
Alarm ADC abnormal
Description The analog-digital converter does not work normally.
Cause 1 Numerical conversion is abnormal.

2 The cell count is abnormal.
Remedy 1 If other instrument alarms exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance and perform maintenance item (1) Reset.
3 If the alarm recurs, remove the reaction disk and check for water droplets or dust
on sensors. Clean if necessary.
4 If the alarm recurs call technical support.
Calc.?
Alarm Calculation not possible
Description The denominator becomes zero in calculation.

e Cause and remedy are identical to the data alarm of the ISE unit.
See Calc.? on page D-10.
Cal.E (Sample flag)
Alarm Calibration result abnormal (Sample flag)
Description No calibration data or previous calibration data used.
Cal.E appears on each QC and patient sample for the affected test until the problem is
resolved.
Cause Any alarm (for example, Std.E) occurred during calibration.
Remedy 1 Correct the condition causing the alarm that occurred during the latest
calibration.
2 Recalibrate.
Roche Diagnostics
ClcT.E
Alarm Calculated test error
Description Calculation error has occurred.
See ClcT.E on page D-11.
CmpT.?
Description During test-to-test compensation calculation, the denominator became zero. Blank
space is left in the report.
See CmpT.? on page D-12.
CmpT.E
Description 1 In test-to-test compensation calculation, a data alarm for other than those shown
below is indicated for the compensation test data.
2 Calculation not possible (Calc.?), data error in compensated test (CmpT.E),
overflow (Over.E), random error (R4SD), systematic error (S2-2Sa, S2-2Sw,
S4-1Sa, S4-1Sw, S10Xa, S10Xw), QC error (Q2.5SD, Q3SD), and outside of
expected value (H/L only on the printout).
See CmpT.E on page D-12.
Roche Diagnostics
>Cuvet
Alarm Cell blank abnormal
Description For a diluted test the cell blank value of the second reaction cell exceeds the reference
by more than 0.1Abs. The reference is the stored value from the (3) Cell Blank
Measurement.
If a reaction cell fails the cell blank measurement, the system excludes it from any
measurements.
For diluted tests however, the system uses two reaction cells:
o 1st cell: Contains sample and diluent.
o 2nd cell: Used for discharging diluted sample from the 1st cell, adding reagent,
and performing measurement.
The >Cuvet alarm indicates a failed cell blank measurement for the 2nd cell.
e For more information about cell blank measurement, see
Cell rinse unit on page A-53
Flow of photometric analysis on page A-55
Cell Blank Measurement window on page E-284
Cause Reaction cells are contaminated or damaged.
Remedy 1 Check that the reaction cell is not contaminated or cracked.

2 Choose Utility > Maintenance and perform maintenance item (6) Wash
Reaction Parts.
3 Check that there is no excessive foaming or particles in the incubator bath. If you
notice excessive foaming or particles, perform maintenance item (4) Incubation
Water Exchange.
4 Wipe the outside of the reaction cells with a gauze pad moistened with incubator
bath water. Perform maintenance item (4) Incubation Water Exchange.
5 Resume operation. If alarm recurs, ensure there is adequate rinse water and cell
blank water from the rinse mechanism. The cells must be completely filled.
6 Resume operation. If alarm recurs, choose Utility > Maintenance and perform
maintenance item (3) Cell Blank Measurement.
If an Abnormal Cell List is displayed on the Cell Blank Measurement report, the
cell blank failed. The cells listed in the Abnormal Cell List did not compare to cell
no. 1. These cells need to be inspected and the (3) Cell Blank Measurement must
be performed again.
M8: Replacing reaction cells and cleaning incubator bath and drain filter on page C-68.
Roche Diagnostics
Det.S
Alarm Detergent short (carryover evasion)
Description If a special wash for the reagent probe is defined, the reagent probe plunges into the
cobas c pack with the specified detergent. This alarm occurs, if the test is carried out
even though the detergent volume is insufficient.
Cause The residual volume of the special wash detergent is insufficient.
Remedy 1 Load a new cobas c pack with the specified detergent.

2 Check the results of the measurement and rerun the sample if necessary.
Edited
Alarm Edited test
Description An edited first result or replaced rerun result is marked with an Edited alarm on the
Data Review screen. This also prints on the patient report.
Cause The result data has been edited.
H (only on printouts)
Alarm Outside of the upper expected value

e Description, cause, and remedy are identical to the data alarm of the ISE unit.
See H (only on printouts) on page D-13.
>Index
Alarm Serum index check
Description In one or more tests, the L, H, I value is larger than the specified reference value
(Utility > Application > Range).
The serum index check is performed after all test results are generated. If a data alarm
is already attached to the result, no serum index check will be performed.
Cause A highly lipemic, hemolytic, or icteric sample has been measured.
Roche Diagnostics
>Kin
Alarm Prozone error 2 / Kinetic unstable
Description The prozone check value exceeds the specified limit value. (Reaction rate method)
Cause o The sample concentration is too high.

o The limit value is not set properly.
Remedy 1 Dilute and rerun the sample or rerun the sample with a decreased sample volume.
2 To avoid check, set [0] [0] [0] [0] [0] [0] [Inside] [0] [0] for Prozone Limit (on
Utility > Application > Analyze).
>Lin
Alarm Linearity abnormal
Description In a rate assay, the reaction linearity exceeds the specified limit value.
Cause o The photometer lamp is deteriorated.

o The linearity check value is not set properly.
o The sample is extremely lipemic.
o The ultrasonic mixers are defective.
o Debris are in the incubation bath.
Remedy 1 Check the photometer lamp.

2 Dilute and rerun the sample.
3 Choose Utility > Application > Analyze to check the Linearity Limit.
4 Choose Utility > Maintenance > Check (on Maintenance Type list) and perform
maintenance check (6) Cuvette Mixing to check the ultrasonic mixing
mechanisms.
5 Ensure the incubator bath is free of debris. Clean the incubator bath, if necessary.
e See M8: Replacing reaction cells and cleaning incubator bath and drain filter on
page C-68.
L (only on printouts)
Alarm Outside of the lower expected value

e Description, cause, and remedy are identical to the data alarm of the ISE unit.
See L (only on printouts) on page D-15.
Roche Diagnostics
Mix.E
Alarm Ultrasonic mixing error
Description There is no ultrasonic output for mixing.
Cause o The water level in the incubator bath is too low.

o The water level sensor of the incubator bath is abnormal.
Remedy Supply water to the incubator bath.
<Mix
Alarm Mixing power low level
Description The ultrasonic monitor value is lower than the reference value.
Cause The ultrasonic mixer is deteriorated.
Remedy 1 Clean the surface of the ultrasonic mixers.

e See M15: Cleaning the ultrasonic mixer on page C-93.
Over.E
Alarm Overflow
Description Display is not possible because the output figure exceeds 6 digits
Cause o The K factor has more than six digits due to the use of a wrong calibrator.
o The data is obtained in more than six digits including a negative sign and decimal
point.
Remedy o Minimize the difference in concentration between the sample and calibrator.
o Obtain the result data with six characters including negative sign and decimal
point.
Roche Diagnostics
>Proz
Alarm Prozone error 1
Description The prozone check value exceeds the specified limit value. (Antigen readdition
method)
Cause o The sample concentration is too high for immunological test.

o The limit value is not set properly.
Remedy 1 Check the reagent preparation.

2 Dilute and rerun the sample or rerun the sample with decreased sample volume.
3 Choose Utility > Application > Analyze to check the upper prozone limit.
4 Resume operation. If the alarm recurs, call technical support.
>React
Alarm Reaction limit over (substrate depletion)
Description In a rate assay, main wavelength absorbance exceeds the specified limit value.
Cause o The sample concentration is too high.

o The reagent has been prepared improperly or is deteriorated.
o On Utility > Application > Analyze there is an improper setting in the
Increase/Decrease box in the Abs. Limit line.
Remedy 1 Verify the setting in the Increase/Decrease box on Utility > Application >
Analyze.
2 Dilute and rerun the sample or rerun the sample with a decreased sample volume.
3 Prepare the reagent newly.
ReagEx
Alarm Reagent expired
Description The alarm indicates that an expired reagent was used; the test result is not
guaranteed. The alarm can be inactivated under Utility > Application > Alarm.
Cause The analyzer detected an expired reagent on board.
Remedy 1 Expired reagents are listed on the reagent unload list with the ReagEx alarm.
2 Exchange expired reagents.
Roche Diagnostics
>Rept / <Rept
Alarm Repeat limit over (upper / lower)
Description The result falls outside the repeat limit range programmed on Utility >
See >Rept / <Rept on page D-16.
Samp.?
Alarm ABS maximum over (non-lin curve)
Description The absorbance of a sample is found equal or greater than the theoretical maximum
absorbance (for infinite analyte concentration). The result field will be left blank on
the report and Data Review screen. This blank result is transmitted, together with the
alarm code “>” to the Host.
Cause The sample concentration is too high.
Remedy Dilute the sample, if required, and rerun. If automatic rerun is programmed, the
sample will be rerun with a decreased sample volume.
Samp.C
Alarm Sample clot
Description The specified volume of sample is not aspirated.

See Samp.C on page D-17.
Samp.S
Alarm Sample short
Description The liquid level cannot be detected in the sample container.

See Samp.S on page D-16.
>Test / <Test
Alarm Upper/Lower technical Limit
Description The measured value is outside the technical limit range entered on Utility >
See >Test / <Test on page D-18.
Roche Diagnostics
Alarms for calibrations
The following table displays all calibration data alarms applicable to ISE tests,
photometric tests, and their presentation (flag) on screens and reports.

Cal.E (Calib flag) CALIB error (Calib flag) l –
Cond.E Conditioning (ISE) abnormal l –
Dup.E Duplicate error – l
IStd.E Internal standard concentration abnormal l –
Prep.E Preparation abnormal l –
Rsp1.E Response (ISE) abnormal 1 l –
Rsp2.E Response (ISE) abnormal 2 l –
S1A.E Standard solution 1 absorbance (S1Abs) abnormal – l
SD.E Standard Deviation limit error – l
Sens.E Sensitivity error – l
Slop.E ISE slope abnormal l –
Std.E Standard error l l
Table D-2 List of data alarms for calibrations
Cal.E (Calib flag)
Alarm CALIB error (Calib flag)

Displayed in Calibration > Status > Calibration Trace.
Description The current ISE calibrator concentration value or slope value differs from the
previous one by more than the specified Compensated Limit. The Compensated
Limit is a limit for the difference | previous value – current value | expressed as
percentage of the average (previous value + current value)/2.
The Cal.E alarm is a warning only, not necessarily indicative of a problem with the
calibration. Check the test’s control recovery before accepting the new calibration result.
Cause o The ISE calibrators or ISE reagents are not placed in proper position.
o The ISE reagents have deteriorated or the ISE calibrators have become
concentrated due to evaporation.
Remedy o Correct any other instrument and/or data alarms.

o Check calibrators, reagents, and controls. If controls are in range, and calibrators
and reagents are acceptable, resume operation. Otherwise, correct abnormalities
and recalibrate.
o Check Compensated Limit on Utility > Application > Calib.
Roche Diagnostics
Cond.E
Alarm Conditioning (ISE) abnormal
Description The slope value is 68.1 mV or greater for Na+ or K+ electrodes, or it is -68.1 mV or
less for the Cl- electrode. The conditioning is inadequate.
+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV
- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV
Figure D-1 ISE data alarms and corresponding slope values (EMF values)
Cause o Conditioning of a new electrode is unsatisfactory.

o The concentration of the calibrators ISE Low [Std(1)] or ISE High [Std(2)] is
improper.
Remedy 1 Run 10 dummy samples of human serum.

2 Prepare fresh calibrators ISE Low [Std(1)], ISE High [Std(2)], and ISE Comp.
[Std (3)], place them onto the sample disk and recalibrate the ISEs.
Roche Diagnostics
Dup.E
Alarm Duplicate error

Description The difference between the first and second measurement (absorbance) of a
calibrator is outside the specified range.
The following steps describe how a decision is made to flag a calibration for violating
the duplication limit.
1 The absorbance for a calibrator (N) is measured twice.
2 The % of error and absorbance error are calculated.
3 Is the absorbance error < Duplicate Limit Abs. that appears on Utility >
Application?
If no, go to step 5.
If yes, go to step 4.
4 Continue with result calculations. No Dup.E alarm is issued.
5 Is the % error < the % Duplicate Limit?
If no, go to step 6.
If yes, go to step 4.
6 Dup.E alarm is issued for this result.
Cause The difference between the first and second measurement (absorbance) of a
calibrator is greater than Duplicate Limit Abs and greater than the % Duplicate Error.
Remedy 1 Recalibrate.
2 Check reagent preparation and expiration date. Prepare new reagent if necessary
and recalibrate.
3 If alarm recurs, call technical support.
If this alarm occurs, a Std.E alarm is issued. The Std.E alarm prevents updating of
calibration for the affected test.
Roche Diagnostics
IStd.E
Alarm Internal standard concentration abnormal

Displayed on Calibration > Status > Calib Trace
Description The concentration of the Internal Standard solution (ISE IS) was not within the
following ranges:
Na+ 120.0-160.0 mmol/L

+
K 3.0-7.0 mmol/L
-
Cl 80.0-120.0 mmol/L
Cause o The flow path is contaminated.

o The reagent has deteriorated.
Remedy 1 If the EMF of ISE IS is abnormal on the calibration report, check the ISE IS
reagent volume and preparation. If necessary, prepare fresh reagent, prime and
recalibrate.
2 If the EMF of ISE IS is normal on the calibration report, check ISE reagent
syringe. The EMF of ISE IS lies ideally midway between the low and the high
standard. The ideal ISE IS concentrations values are: Na+: 140 mmol/L; K+:
5 mmol/L; Cl-: 100 mmol/L.
4 Perform maintenance item (10) ISE Wash to wash the flow path of the ISE unit.
e See M1: Washing ISE flow path and sample probe on page C-47
5 Replace the diluent and internal standard solution.
Roche Diagnostics
Prep.E
Alarm Preparation abnormal

Displayed on Calibration > Status > Calib Trace.
Description The slope value is within the following range: 45.0 to 49.9 mV for Na+ or K+
electrodes, -39.9 to -35.0 mV for the Cl- electrodes.
+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV
- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV
If the alarm “ISE slope marginal (Prep.E)” appears, you may continue the day’s
analyses but the cartridges must be replaced the next day. Check the QC to verify that
the slope is acceptable

o The electrode is deteriorated.
Remedy 1 Perform maintenance item (10) ISE Wash to wash the flow path of the ISE unit.
2 Replace the electrode.
Roche Diagnostics
Rsp1.E
Alarm Response (ISE) abnormal 1
Description The A Factor (response compensation factor) is outside the following limits:
Na+ A > 0.154

K+ A > 0.107
Cl- A > 0.330

o The electrode is contaminated or deteriorated.
Remedy 1 Check ISE controls for correct levels.

2 If incorrect, go to step 3 before continuing routine analysis. If correct, go to step 3
after finishing routine analysis at the end of the day.
4 Run 10 dummy samples of human serum.

5 Prepare fresh calibrators, place them onto the sample disk and recalibrate the
ISEs.
6 Resume operation. If alarm recurs, repeat steps 3 through 5 a maximum of two
times. If alarm recurs, replace the ISE cartridges.
Rsp2.E
Alarm Response (ISE) abnormal 2
Description The A Factor is outside the following limits:
Na+ A > 0.232

K+ A > 0.160
-
Cl A > 0.490

o The electrode is contaminated or deteriorated.
Remedy e See Rsp1.E on page D-33.
Roche Diagnostics
S1A.E
Alarm Standard solution 1 absorbance (S1Abs) abnormal

Description During calibration, expected absorbance is outside the S1 Abs Limit. S1 is read
bichromatically for endpoint assays, monochromatically for rate assays.
Cause o The reagent has been prepared improperly or has deteriorated.

o An improper absorbance range is specified for calibrator 1.
Remedy 1 Check reagent preparation and calibration.

2 Recalibrate.
3 Check S1 Abs. Limit values on Utility > Application > Calib.
SD.E
Alarm Standard Deviation limit error
Description During nonlinear or multipoint linear calibration, the SD value was larger than the
SD limit programmed on Utility > Application.
The result of the calibration is updated.
Cause o The calibrator is not placed at the correct position.

o An improper SD limit value is specified.
Remedy 1 Check calibrator positions on Calibration > Calib.

2 Choose Utility > Application > Calib. to check the SD Limit.
3 Check preparation and expiration dates of calibrators and reagents. Recalibrate
the affected test.
4 Check the standard concentrations on Calibration > Install. For a calibration
with automatic standard dilution; check whether the ratio between concentration,
sample, diluent volume and diluted sample is correct on Utility > Application >
Others.
Roche Diagnostics
Sens.E
Alarm Sensitivity error
Description Sensitivity is checked for both linear (2 to 6 points) and nonlinear calibrations. This
alarm is indicated if the sensitivity value obtained in a calibration falls out of the
sensitivity limits specified on Utility > Application > Calib.
A sensitivity value is calculated from the measured absorbance values ( Abs ) and
given concentration values ( Conc ) of the blank calibrator ( S1 ) and the calibrator
SN :
Abs  S N  – Abs  S 1   Conc  S N  – Conc  S 1  , where
S N = Std 2 for 2 Point calibrations and span calibrator for multipoint calibrations
For span calibration, the previous S1 Abs (linear) or previous mean absorbance (nonlinear)
of calibrator (1) is used for the sensitivity check.
Cause o An improper sensitivity limit is specified.

o The calibrator or reagent is not placed at a proper position.
o The reagent has been prepared improperly or has deteriorated.
Remedy 1 Check preparation and expiration dates of calibrators and reagents. Recalibrate
the affected test.
2 Check sample pipetter for leaks and recalibrate the affected test.
3 Choose Utility > Application > Calib. to check the sensitivity limit and
recalibrate the affected test.
Roche Diagnostics
Slop.E
Alarm ISE slope abnormal

Displayed on Calibration > Status > Calib Trace.
Description The slope value is less than 45.0 mV for Na+ or K+ electrodes, or
greater than -35 mV for the Cl- electrode.
+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV
- 68 - 65 - 60 - 45 - 40 - 35 - 30 mV
Cause o The electrode is deteriorated.

o The calibrators ISE Low [Std(1)] or ISE High [Std(2)] are not placed in the proper
positions.
o The sample probe is clogged.
Remedy 1 Replace the appropriate ISE cartridge before continuing routine analysis.
e See M14: Replacing ISE measuring cartridges (Cl, K, Na) on page C-87.
2 Run 10 dummy samples of human serum.

3 Prepare fresh calibrators; place them onto the sample disk and recalibrate the
ISEs.
Roche Diagnostics
Std.E (ISE)
Alarm Standard error
Description 1 During ISE calibration, any one of the following alarms was encountered:
Data alarm Data flag

ADC abnormal ADC.E
Calculation not possible Calc.?
ISE voltage level error ISE.E
ISE noise error ISE.N
Mixing power low level <Mix
Ultrasonic mixing error Mix.E
Sample short Samp.S
Table D-3 ISE data alarms giving rise to an Std.E alarm when occurring in calibration
2 During calibration, calculation was disabled.
The calibration is not updated if this alarm is issued; i.e. the prior calibration remains in
effect.
Cause o The reagent is empty and has to be replaced.

o The concentration of calibrator is improper or the calibrator is not placed in the
proper position.
o An improper check value is specified.
Remedy 1 Correct any other instrument and/or data alarms.

2 Prepare fresh calibrators; place them onto the sample disk and recalibrate.
3 Replace reagent, prime, and recalibrate.
4 Choose Utility > Application to check the calibration parameters.
Roche Diagnostics
Std.E (P)
Alarm Standard error
Description 1 During photometric calibration, any one of the following alarms was
encountered:
Data alarm Data alarm

ABS over (absorbance exceeds 3.0) >Abs
ADC abnormal (analog/digital converter) ADC.E
Calculation not possible Calc.?
Cell blank abnormal >Cuvet
Duplicate error (difference between 1st and 2nd Dup.E
calibrator measurement)
Linearity abnormal (for rate assays) >Lin
Mixing power low level <Mix
Ultrasonic mixing error Mix.E
Reaction limit over (substrate depletion) >React
Reagent short Reag.S
Sample short Samp.S
Standard solution 1 absorbance (S1Abs) abnormal S1A.E
Table D-4 Photometric data alarms giving rise to an Std.E alarm when occurring in
calibration
2 During calibration, calculation was disabled.

3 During nonlinear calibration, an extreme value appeared.
The calibration is not updated if this alarm is issued; i.e. the prior calibration remains in
effect.
Cause o The reagent has not been prepared properly or is empty and has to be replaced.
o The concentration of calibrator is improper or the calibrator is not placed in the
proper position.
o An improper check value is specified.
Remedy 1 Correct any other instrument and/or data alarms.

2 Prepare fresh calibrators; place them onto the sample disk and recalibrate.
3 Replace reagent and recalibrate.
4 Choose Utility > Application to check the calibration parameters.
Roche Diagnostics
Data alarms for controls
Q3SD
Alarm 1-3SD (QC error 1)
Description In Realtime QC the control X or control Y data value is above 3 SD or below -3 SD.
Cause o The control is not properly prepared.

o The control is not properly positioned on the analyzer.
o The control is concentrated or deteriorated.
o Control values (mean value, standard deviation) are not correctly specified.
o The reagents are not properly prepared.
o Reagent is deteriorated (e.g., linearity of working curve degraded).
o Poor precision due to leakage of the pipetter joint.
This check is performed only when RULE 1-3 SD is selected (in QC > Individual >
Realtime QC > Rules).
Remedy 1 Check that controls and reagents are properly prepared, positioned, and stored.
2 Check correct lot number and expiration dates of controls and reagents.
3 Check that the control values (mean value, standard deviation) are entered
correctly on QC > Install.
4 Prepare a new control and analyze it.
5 Prepare a new calibrator and perform a calibration.
6 Load a new cobas c pack or replace with a new cobas c pack.
7 Check the pipetter (Maintenance Check).
Roche Diagnostics
Q2.5SD
Alarm 1-2.5SD (QC error 2)
Description In Realtime QC the control X value or control Y data value is above 2.5 SD or below
-2.5 SD.
This check is performed only when RULE 1-2.5SD is selected (in QC > Individual >
e For cause and remedy description, see:

Q3SD on page D-39
R4SD
Alarm R-4S (Random error in realtime QC)
Description In Realtime QC one of X and Y data values is above 2 SD and the other is below
-2 SD.
This check is performed only when RULE R-4SD is selected. N = run size entered on
Select Rules window (in QC > Individual > Realtime QC > Rules).

Q3SD on page D-39
S2-2Sa
Alarm 2-2SA (Syst. error 1 - 2 results)
Description In Realtime QC the control X and Y values are above 2 SD or below -2 SD.
This check is performed only when RULE 2-2SD is selected (in QC > Individual >

Q3SD on page D-39
Roche Diagnostics
S2-2Sw
Alarm 2-2SW (Syst. error 2 - 2 samples / 4 results)
Description In Realtime QC the last two control X or last two control Y values were above 2 SD or
below -2 SD.
Cause o Control values (mean value, standard deviation) are not correctly specified.
o The reagents are not properly prepared.
o Reagent is deteriorated (e.g., linearity of working curve degraded).
o Poor precision due to leakage of the pipetter joint.
Remedy 1 Check that the control values (mean value, standard deviation) are entered
correctly on QC > Install.
2 Check that reagents are properly prepared, positioned, and stored.
3 Check correct lot number and expiration dates of reagents.
4 Load a new cobas c pack or replace with a new cobas c pack.
5 Prepare a new calibrator and perform a calibration.
6 Prepare a new control and analyze it.
7 Check the pipetter (Maintenance Check).
S4-1Sa
Alarm 4-1SA (Syst. error 3 - 4 results)
Description In Realtime QC the last two X and Y data values are above +1 SD or below -1 SD.

S2-2Sw on page D-41
Roche Diagnostics
S4-1Sw
Alarm 4-1SW (Syst. error 4 - 4 samples / 8 results)
Description In Realtime QC the last four control X or last four control Y values are above 1 SD or
below -1 SD.

S2-2Sw on page D-41
S10Xa
Alarm 10XA (Syst. error 5 - 10 results)
Description In Realtime QC the last five X and Y data values fall on the + or - side of the mean
value.
This check is performed only when RULE 10X is selected (in QC > Individual >

S2-2Sw on page D-41
S10Xw
Alarm 10XW (Syst. error 6 - 10 samples / 20 results)
Description In Realtime QC the last 10 control X or last 10 control Y values are positive-above the
mean value or negative-below the mean value.
This check is performed only when RULE 10X is selected (in QC > Individual >

S2-2Sw on page D-41
Roche Diagnostics
Data problems without alarm
Drift of result data
Cause o Concentration or deterioration of sample.

o The calibrator is concentrated or deteriorated.
o The reagent flow path is contaminated (ISE unit).
Remedy 1 Avoid leaving the sample in the sample cup for a long time.
Erroneous operation
Cause o Neglect of preliminary or periodical check(s).

o Carryover between tests.
o Fibrin contained in sample or dust contained in reagent.
o The sample container that was used, was not recommended.
Remedy 1 Carry out preliminary and/or periodical check according to the specified
procedure.
2 Change the channel, use the wash program, or take any other measure after
consulting with the reagent manufacturer.
3 Eliminate fibrin or dust. Be sure to check the sample and reagent before setting
them.
4 Perform maintenance item (11) Sample Probe Wash.
5 Use the recommended sample container.
Roche Diagnostics
Poor reproducibility
Cause o A maintenance item is overdue.

o Deterioration of reagent or precipitation of insoluble matter.
o Deterioration of ISE reagents.
o Poor deionized water quality.
o Reagent handling was not done as recommended.
o Test parameters are not set properly.
o Air bubbles in the sample or reagent syringe (poor reproducibility).
o Liquid leakage from sample or reagent syringe (poor reproducibility).
o One of the ISE electrodes is contaminated or deteriorated (high value or low
value).
Remedy 1 Carry out daily checks and periodical maintenance according to the specified
maintenance procedure.
2 Replace with a new cobas c pack.
3 Replace with new ISE reagents. Do not add or mix old and new reagent.
4 The water quality must be 1 S/cm (microsiemens per cm) or less.
5 Use the recommended reagent handling.
6 Check the completeness of the special wash list. If necessary, install the special
wash list according to the recommendation of the manufacturer.
7 Check for air bubbles and liquid leakage at the syringes.
o For sample syringe or reagent syringe perform an air purge (see To perform an
air purge (sample syringe or reagent syringe) on page C-106).
o For ISE sipper syringe perform a reagent prime (see To perform an air purge
(sample syringe or reagent syringe) on page C-106).
8 Perform maintenance item (10) ISE Wash to clean the ISE flow path or replace
the ISE measuring cartridges with new ones.
e See:
M14: Replacing ISE measuring cartridges (Cl, K, Na) on page C-87
M22: Replacing the ISE reference cartridge on page C-119
Roche Diagnostics
Result data at high level
Cause o Concentration of control or sample.

o Deterioration of calibrator.
o The reagent, control and calibrator handling was not done as recommended.
Remedy 1 Avoid leaving the sample or control in the sample cup for a long time.
2 Avoid leaving the calibrator in the sample cup open for a long time.
4 Use the recommended reagent, control and calibrator handling.
Result data at low level
Cause o Concentration of calibrator.

o Reagent handling was not done as recommended.
o The test parameters are not set properly.
Remedy 1 Use the calibrator immediately after opening the cap of the vial.
2 Prepare the reagent again by the correct method.
3 Set the concentration of calibrator, measuring wavelength, etc. properly.
Trouble attributed to characteristics of reagent
Cause o Cross contamination (high value, low value)

o Colored matter from the reagent or due to the reaction may adhere to the reaction
cell.
Remedy 1 Perform maintenance item (6) Wash Reaction Parts.

2 Check whether the special wash list is complete. Install the special wash list
according to the recommendations of the manufacturer.
e Special Wash on page B-255
Roche Diagnostics
Trouble with a test
Cause o Improper preparation or management of calibrator or control (high value, low

value).
o Improper management of reagent (low value).
Remedy 1 Prepare a new calibrator or control.

2 Replace with a new reagent.
3 Set the test parameters properly according to the setting table given by the reagent
manufacturer.
Roche Diagnostics
Rerun list
Rerun list
The following table indicates whether a rerun is automatically requested by the

analyzer when a data alarm is attached to a result. The rerun conditions are displayed
under the ISE unit and photometric unit. The automatic rerun column indicates
whether a rerun is automatically requested by the analyzer.
Increase Sample is rerun at an increased sample volume

Normal Sample is rerun at same sample volume (repeat)
Decrease Sample is rerun at a decreased sample volume
Alarm ISE unit Photometric Auto rerun

unit
ABS over >Abs - Decrease Yes
ADC abnormal ADC.E Normal Normal Yes
Calibration result abnormal (Sample flag) Cal.E (Sample flag) Normal Normal No
Calculation not possible Calc.? Normal Normal Yes
Calculated test error ClcT.E No rerun No rerun No
Unable to calculate compensated test CmpT.? Normal Normal Yes
Data error in compensated test CmpT.E Normal Normal Yes
Cell blank abnormal >Cuvet - Normal Yes
Detergent short (carryover evasion) Det.S - Normal No
Edited test Edited No rerun No rerun No
Serum index check >Index - No rerun No
ISE voltage level error ISE.E Normal - Yes
ISE noise error ISE.N Normal - Yes
Prozone error 2 / Kinetic unstable >Kin - Decrease Yes
Linearity abnormal >Lin - Normal Yes
Ultrasonic mixing error Mix.E Normal Normal No
Mixing power low level <Mix Normal Normal Yes
Prozone error 1 >Proz - Decrease Yes
Reaction limit over (substrate depletion) >React - Decrease Yes
Reagent expired ReagEx No rerun No rerun No
Reagent short Reag.S Normal Normal No
Repeat limit over (upper / lower) >Rept / <Rept Normal Normal Yes/No due to
setting
ABS maximum over (non-lin curve) Samp.? - Decrease Yes
Sample clot Samp.C Normal Normal No
Sample short Samp.S Normal Normal No
ISE range over >Test Normal - Yes
ISE sample range outside technical limit, >Test For urine: Decrease Yes
photometric unit: Upper/Lower technical Limit Decrease (a)
For others:
Normal
<Test Normal Increase Yes
Table D-5 Rerun list
(a) For Urine Decrease: Can only be requested manually.
Roche Diagnostics
Rerun list
Roche Diagnostics
cobas c 311 analyzer 16 Troubleshooting
Table of contents
Troubleshooting
This chapter provides general information about troubleshooting problems on the


General troubleshooting .............................................................................................. D-51
Troubleshooting procedures ................................................................................. D-51
Operator's primary responsibility .................................................................. D-51
Calling technical support ....................................................................................... D-52
General information needed: .......................................................................... D-52
Chemistry problem ........................................................................................... D-52
Instrument problem ......................................................................................... D-52
Backup of the system data files (getlog procedure) ............................................ D-53
General instrument troubleshooting .......................................................................... D-56
Troubleshooting at Power Up ............................................................................... D-56
Instrument does not power up ....................................................................... D-56
General mechanical problem isolation ................................................................ D-57
Electrical power not available ................................................................................ D-57
Cannot access another screen ............................................................................... D-57
Touchscreen does not come on ............................................................................ D-58
Touchscreen is difficult to see ............................................................................... D-58
Bubbles in syringe ................................................................................................... D-58
ISE troubleshooting ...................................................................................................... D-59
ISE, results are erratic ............................................................................................. D-59
ISE, all results are erratic, excessive air in sipper syringe .................................. D-60
ISE, only one wrong result ..................................................................................... D-62
ISE, high or low internal standard values ............................................................ D-63
ISE, high sodium or low chloride values ............................................................. D-64
Low ISE values ......................................................................................................... D-65
Roche Diagnostics
16 Troubleshooting cobas c 311 analyzer
Table of contents
Troubleshooting of the photometric unit .................................................................. D-66

High test results ....................................................................................................... D-66
Low test results ........................................................................................................ D-67
Erratic test results .................................................................................................... D-68
Erratic or biased test results ................................................................................... D-69
Single sample or control ........................................................................................ D-70
Single test (1 reagent) ............................................................................................. D-70
Tests with more than 1 calibration point ............................................................ D-71
Multiple photometric tests (more than 1 reagent) ............................................. D-71
All photometric tests .............................................................................................. D-72
Biased enzyme results ............................................................................................. D-72
Roche Diagnostics
General troubleshooting
This chapter provides general information about troubleshooting problems on the

Troubleshooting procedures
To identify and isolate problems effectively, you must understand the theory of
operation, operating procedures, emergency procedures and test reaction
descriptions covered in this manual. The following areas are covered:
Application problems o Photometric or ISE

o Reagents
o Samples, controls or calibrators
o Operator error
Instrument problems o Electrical/electronic

o Mechanical
o Operator error
Computer problems o Problems during download procedure, incorrect parameters

o System parameter reading
o Operator error
Facility problems o Heat

o Humidity
o Power supply
o Water supply
o Drain
Operator's primary responsibility

o Reagent, calibrator and control preparation and storage according to instruction
for use.
o Sample preparation
o Software configuration and general computer input/output operations
o Basic operator technique, including computer operation
o Maintenance
The basic operator is not responsible for troubleshooting electrical problems except as
covered in this part of the Operator’s Manual.
When troubleshooting, observe and record the alarms and isolate the problem to the
area denoted by the alarms. Follow instructions of the alarm message and follow the
remedies herein. In many cases, you may be able to find the problem, correct it and
then resume processing. The remainder of this chapter provides instructions and
guidelines to aid in isolating problems.
Roche Diagnostics
Calling technical support
If it becomes necessary to consult technical support to troubleshoot a test or

instrument problem, be prepared with the following information:
e The items are divided into the following categories:
General information needed: on page D-52
Chemistry problem on page D-52
Instrument problem on page D-52
General information needed:

o account number / customer ID number
o instrument serial number
o software version
o when the problem first occurred
o description of the problem including relevant alarm(s)
o alarm code number, if possible printout
o additional instrument or maintenance related information
Chemistry problem
o test(s) affected and other tests on board
o special wash programming
o catalog number, lot numbers and expiration dates of reagents
o catalog number, lot numbers and expiration dates of calibrators and controls
o lot number of ISE cartridges
o calibration monitor printout from the last few calibrations performed and/or
calibration trace printout
o control results from the last few controls performed
o patient results (with correlation results, if relevant)
o Reaction Monitor report for affected test(s) printed out via Print > Workplace >
Reaction Monitor
Instrument problem
o account number/customer ID number
o instrument serial number and software version
o description of the problem including relevant alarm(s) and alarm code numbers
o other instrument or maintenance related information.
Roche Diagnostics
Backup of the system data files (getlog procedure)
For further investigation by the technical support it could be necessary to compile a

backup of the system data files (so-called getlog files). Follow the procedure below, if
the technical support prompts you to make a backup of the system data files.
a To compile a backup of the system data files

1 Check if the following conditions are fulfilled:
o No alarm is active
O The Alarm global button is not flashing
e For checking the alarms, see Check system alarms on page B-43
o The host communication is OFF
O No icon for the host in the status line
e For deactivating the host communication, see Host Setting window on page E-125
o The analyzer is in standby mode
2 Choose Utility > Maintenance > Check (Maintenance Type) > (1) Disk Check >
Select.
Figure D-4 Disk Check window
3 Select the Backup DataFile option and choose Execute.
Roche Diagnostics
4 Choose Yes to confirm the following Confirmation window.

o The Processing window pops up.
o After the Processing window is closed the files are compressed automatically.
Figure D-5 Backup data files process
5 Press <Windows> + <e> on the control unit keyboard to access the Windows
Explorer.
6 Browse to C:\7600\GetLog and open the directory named after the respective
date.
Figure D-6 Windows Explorer
7 Right-click on the file MERGE.TXT and select Rename. Change the file name to
MERGE.BAT and press <Enter>.
8 Choose Yes to confirm the confirmation window about changing the file name
extension.
The file name changes to MERGE.BAT.
Roche Diagnostics
9 Double-click on the file MERGE.BAT.

This process compresses the set of files to a single file (bkup.lzh).
Figure D-7 Compressing system backup data files
Transfer the file bkup.lzh to the technical support.
Roche Diagnostics
General instrument troubleshooting
This chapter provides information about troubleshooting procedures for the analyzer
as a whole. Procedures for troubleshooting general instrument problems as well as
problems during power up are described.
Troubleshooting at Power Up
Conditions that can affect instrument power up are presented in Table D-6.
To troubleshoot a problem, determine the category below that best describes the
problem, and follow the recommended remedy. If all remedies are unsuccessful, call
technical support.
Instrument does not power up
Description: The instrument does not power up when the power switch of the analytical unit is
switched on.
e For the power switch of the analytical unit, see Power switches on page A-27
Cause / Remedy: Cause or description Remedy

1. Instrument is unplugged. Plug instrument power cord into socket.
2. Main circuit breaker (at the rear of the Switch main circuit breaker to the ON
analytical unit, see Figure A-8 on position.
page A-27) in OFF position.
3. Power switch for the analytical unit is Switch on the power switch of the analytical
switched off. unit.
4. The circuit breaker for the instrument Have your facility electrician check the
power line in your facility is in the OFF appropriate circuit breaker.
position.
5. Control unit power cable is unplugged. Plug the power cable into socket. If the
instrument still does not power up, call
technical support.
Table D-6 Troubleshooting instrument: Does not power up
Roche Diagnostics
General mechanical problem isolation
The control unit controls and monitors all mechanical functions of the instrument.
When a mechanical problem arises within the instrument, it is immediately
recognized. The alarm indicator on the global Alarm button flashes, alerting you to
the problem. Touch Alarm (global button) to display the Alarm screen with the
specific alarm code, date and time the alarm occurred and a description of the alarm.
Touch a specific alarm to display the alarm details and appropriate remedy.
For certain problems affecting the instrument's performance, the analyzer terminates
the operation mode and enters the sampling stop or stop mode. In the sampling stop
mode, the analyzer allows completion of the samples in process unaffected by the
failure. In the stop mode the analyzer stops immediately and terminates the
operation mode.
Incorrect results or damage to the instrument due to unrecognized instrument

problems
CAUTION Certain instrument problems may arise that the analyzer does not monitor. If this is the
case, no alarm will be issued to alert the operator. Such problems may include worn parts,
air leaks in the syringe system, reagent contamination, etc.
When you encounter these types of problems, you must decide whether to continue to
process samples or to terminate the operation, depending on the possibility of causing
damage to the analyzer or reporting erroneous test results.
Electrical power not available
e If you have problems powering the analyzer on, see

Instrument does not power up on page D-56
Cannot access another screen
Description: Access of another screen in the software is not possible.

1. A system error occurred. 1. Power OFF the computer by pressing the
power switch of the control unit for at
least 5 seconds (?).
2. Power off the analyzer at the power
switch of the analytical unit.
3. Switch on the power switch of the
analytical unit.
4. switch on the power switch of the control
unit.
2. Access of another screen in the software Call technical support.
is still not possible.
Table D-7 Troubleshooting instrument: Cannot access another screen
e For the power switches and circuit breaker, see Power switches on page A-27
Roche Diagnostics
Touchscreen does not come on
Description: The touchscreen does not come on when the power switch of the control unit is
switched on.

1. The touchscreen is switch off. Switch on the touchscreen.
2. The cable between the touchscreen and Connect the cable between the touchscreen
the control unit is disconnected. and the control unit.
3. The touchscreen still does not come on. Call technical support.
Table D-8 Troubleshooting instrument: Touchscreen does not come on
Touchscreen is difficult to see
Description: The content of the touchscreen is difficult to see.

1. The touchscreen is dirty. Wipe the surface of the touchscreen with a
dry cloth.
2. The ambient light is too bright. Reduce the brightness of the ambient lighting
or change the direction of the monitor.
3. The content of the touchscreen still is Call technical support.
difficult to see.
Table D-9 Troubleshooting instrument: Touchscreen is difficult to see
Bubbles in syringe
Description: Bubbles in reagent and/or sample syringe.

1. Analyzer was not in use for a longer time. Perform maintenance item (5) Air Purge
from Utility > Maintenance. Select the
affected syringe
Repeat if there are still bubbles in the syringe
2. The syringe seal is worn out. Perform maintenance action M18: Replacing
the syringe seals on page C-101.
3. Bubbles remain in reagent and/or sample Call technical support.
syringe.
Table D-10 Troubleshooting instrument: Bubbles in syringe
Roche Diagnostics
ISE troubleshooting
ISE troubleshooting
This chapter provides information about troubleshooting procedures specific to the

ISE unit.
ISE, results are erratic
Description: Erratic ISE results.

1. ISE tubing is not correctly placed in the Place the tubing of the ISE Ref. bottle
ISE Ref. bottle. correctly.
Perform maintenance (7) Reagent Prime on
the ISE unit (REF).
e For information about ISE Ref. tubing
and aspiration filter, see
on page C-73
2. Salt build up on electrodes. Clean all salt build up with wet gauze.
the ISE unit.
3. Loose connection of ISE tubing. Tighten any loose or leaky connection.
the ISE unit.
4. Kinks or occlusions in ISE tubings. Remove all kinks and occlusions.
5. Air bubbles in sipper syringe. Replace the syringe seals of the ISE sipper
syringe.
e See M18: Replacing the syringe seals on
page C-101
6. Microbial growth in the reagent system. Replace the ISE reagent bottles.
e For more information about replacing
the ISE bottles, see ISE reagents on
page B-52
Perform maintenance action M1: Washing
ISE flow path and sample probe on page C-47.
7. Loose signal cable connection. Reconnect the signal cable.
8. ISE unit check: Perform maintenance (7) Reagent Prime on
the ISE unit.
Perform maintenance check (2) ISE Check.
and calibrate the ISE unit.
e See To perform an ISE Check and
calibrate the ISE unit on page C-90
Perform controls for ISE.
e See To perform controls for active
reagents on page B-186
9. ISE results are still erratic. Call technical support.
Table D-11 Troubleshooting ISE: All results are erratic
Roche Diagnostics
ISE troubleshooting
ISE, all results are erratic, excessive air in sipper syringe
Description: Erratic ISE results and excessive air in sipper syringe.

1. Excessive air in sipper syringe. Check and correct the position of the ISE Ref.
tubing and the aspiration filter.
the ISE unit (REF).
e For information about ISE Ref. tubing
and aspiration filter, see
on page C-73
2. Air bubbles in the tubes of ISE Ref. bottle. Perform maintenance (7) Reagent Prime on
the ISE unit (REF).
3. The tubing do not touch the bottom of Correct the position of the tubing.
the ISE Ref. bottle. Perform maintenance (7) Reagent Prime on
the ISE unit (REF).
4. Leaking of the system. Check all tubings and connections for leaks.
Tighten loose fittings.
Check seals of the ISE sipper syringe.
the ISE unit.
5. Leaking of the ISE sipper syringe. Replace the syringe seals of the ISE sipper
syringe.
e See M18: Replacing the syringe seals on
page C-101
6. Leaking of the ISE sipper tubing. Replace the ISE sipper tubing.
e See M17: Replacing the ISE sipper tubing
on page C-98
Table D-12 Troubleshooting ISE: All results are erratic, excessive air in sipper syringe (Sheet
1 of 2)
Roche Diagnostics
ISE troubleshooting
Cause or description Remedy

7. Incorrect position of ISE measuring and Place the cartridge in its proper position.
reference cartridge. Perform maintenance (7) Reagent Prime on
the ISE unit.
e For information about ISE measuring
cartridge, see M14: Replacing ISE
measuring cartridges (Cl, K, Na) on
page C-87
For information about ISE reference
cartridge, see M22: Replacing the ISE
reference cartridge on page C-119
the ISE unit.
9. ISE results are still erratic. Call technical support.
Table D-12 Troubleshooting ISE: All results are erratic, excessive air in sipper syringe (Sheet
2 of 2)
Roche Diagnostics
ISE troubleshooting
ISE, only one wrong result
Description: Only one wrong ISE result.

1. Wrong sample collection tubes (e.g. Follow the recommendation in the
heparin sample tubes). instructions for use.
2. Small air bubbles in ISE reference tubing. Perform maintenance (7) Reagent Prime on
the ISE unit (REF).
3. Signal cable connection of affected Reconnect the signal cable.
electrode (parameter) is loose.
4. Salt build up on affected electrode. Clean all salt build up with wet gauze.
(parameter) Perform maintenance (7) Reagent Prime on
the ISE unit.
the ISE unit.
6. Only one ISE result is still wrong. Call technical support.
Table D-13 Troubleshooting ISE: Only one wrong result
Roche Diagnostics
ISE troubleshooting
ISE, high or low internal standard values
Description: High or low ISE IS EMF values.

1. Old or wrong ISE calibration material. Use only fresh ISE calibration materials.
2. Wrong position of ISE calibration Place ISE calibration material on the correct
material. position.
3. Leaking of the ISE sipper syringe. Replace the syringe seals of the ISE sipper
Wrong assembling of the ISE sipper syringe.
syringe. e See M18: Replacing the syringe seals on
page C-101
the ISE unit.
5. ISE internal standard values are still high Call technical support.
or low.
Table D-14 Troubleshooting ISE: High or low internal standard values
Roche Diagnostics
ISE troubleshooting
ISE, high sodium or low chloride values
Description: High sodium or low chloride values.

1. Old ISE calibration material. Use only fresh ISE calibration materials.
2. Exceeded on board stability of ISE Replace the ISE reagents.
reagent or e See ISE reagents on page B-52
Expired ISE reagent. Perform maintenance (7) Reagent Prime on
the ISE unit.
3. Expired reference cartridge. Replace the ISE reference cartridge.
e See M22: Replacing the ISE reference
cartridge on page C-119
the ISE unit.
5. Still high sodium or low chloride values. Call technical support.
Table D-15 Troubleshooting ISE: High sodium or low chloride values
Roche Diagnostics
ISE troubleshooting
Low ISE values
Description: Low ISE values.

1. Old ISE calibration material. Use only fresh ISE calibration materials.
2. Exceeded on board stability of ISE Replace the ISE reagents.
reagent or e See ISE reagents on page B-52
Expired ISE reagent. Perform maintenance (7) Reagent Prime on
the ISE unit.
3. Expired reference cartridge. Replace the ISE reference cartridge.
e See M22: Replacing the ISE reference
cartridge on page C-119
the ISE unit.
5. Still low ISE values. Call technical support.
Table D-16 Troubleshooting ISE: Low values
Roche Diagnostics
Troubleshooting of the photometric unit
This chapter provides information about troubleshooting procedures specific to the

photometric unit.
High test results
For problems with high test results on the photometric unit, troubleshoot according
to the steps below:
1 Incubation bath temperature is incorrect.
o If the bath temperature does not read 37  0.1C, call technical support.
2 Poor calibration results.
o Check calibrator preparation.
o Check proper calibration programming and calibration results. Repeat
calibration if necessary.
3 Calibrators were not properly prepared.
o Check calibrator preparation and calibration results. Repeat calibration.
4 Evaporation of sample, calibrator or control.
o Repeat analysis with fresh sample, calibrator and/or control.
If calibrators and controls have been loaded on the sample disk for more than
2 hours, evaporation of calibrator may lead to lower results for patient
samples.
5 Reagents are expired.
o Check the expiration date of the reagent.
6 Information is not correct Calibration > Install.
o Verify the calibration points on Calibration > Install and compare the
displayed data with the documentation for a specific test.
o Verify the calibration sample volume in the application parameters.
7 Incorrect sampling or dilution of sample.
o Check correct assembly of sample probe and pipetter parts.
o Check all fittings for leaks.
o Replace O-rings and seals.
8 Insufficient reagent volume.
o Check reagent pipetting system for leaks.
o Replace cobas c pack and repeat analysis.
9 Check that the ultrasonic mixer operates properly.
o Perform maintenance check (6) Cuvette Mixing.
10 If you are still experiencing problems, call technical support.
Roche Diagnostics
Low test results
For problems with low test results on the photometric unit, troubleshoot according to
the steps below:
1 Reagents are expired.
o Prepare new reagents (see instructions for use in cobas link for stability of the
prepared reagent).
2 Reagents were not properly stored.
o Prepare new reagents (see instructions for use in cobas link for proper
storage).
3 Reagents were not properly prepared.
o Prepare new reagents (see instructions for use in cobas link for proper
preparation instructions).
4 Incubation bath temperature is incorrect.
o If the bath temperature does not read 37  0.1C, call technical support.
5 Calibrators were not properly prepared.
o Check calibrator preparation and repeat the calibration with fresh calibrators.
6 Information is not correct on Calibration > Install.
o Check Calibration > Install and compare the displayed data with the
documentation for a specific test.
o Verify the calibration sample volume in the application parameters.
7 Ensure there is sufficient sample in the container. Check instrument
specifications for minimum sample volumes.
8 Check sample for fibrin clotting.
9 Check sample pipetting systems for leaks and air bubbles.
10 Check sample probe for contaminants and obstructions.
11 Repeat analysis with appropriate sample volume.
12 Check sample probe for barbs and proper alignment.
13 Check the cell rinse nozzles are not dripping.
Roche Diagnostics
Erratic test results
For problems with erratic test results on the photometric unit, troubleshoot
according to the steps below:
1 Fibrin clot in 1 sample container or in sample probe (if low values printed for
several samples).
o Check sample for fibrin clot; remove fibrin and repeat analysis.
o Check sample probe for fibrin clot; clean probe (perform maintenance item
(11) Sample Probe Wash) and perform an air purge.
e See also M2: Cleaning pipetter probes and ISE sipper nozzle on page C-51.
o Replace sample probe and sample probe seal.
2 Sample probe does not reach the bottom of the reaction cell when dispensing
sample.
o Perform mechanisms check and verify that the probe reaches the bottom of
the cell.
o Check the spring mechanism to make sure the probe moves up and down
freely.
o The sample probe tip may be damaged. Replace the sample probe.
3 Maintenance was not performed properly or at the recommended frequency on
sample or reagent pipetter or probe.
o Check the Maintenance screen and perform any overdue maintenance
functions.
o If maintenance was recently performed on the sample probe, reagent probe,
rinse nozzles, or any pipetters:
O Was an air purge performed after maintenance?
O Were all parts correctly assembled?
O Have all tubings and seals been checked for air leaks?
O Were sample and reagent probe seals replaced?
4 Insufficient sample volume.
o Repeat analysis with sufficient sample.
5 Contaminated incubation bath.
o Check for particles in the incubation bath. If particles exist, perform the
incubation cleaning procedure
e See: M8: Replacing reaction cells and cleaning incubator bath and drain filter on
page C-68
o Check for foaming, perform incubation bath exchange.
o Check for sufficient Hitergent on the analyzer. Perform incubation water
exchange.
6 Check for sufficient volumes of cell cleaning detergents.
7 Observe cell wash for proper operation:
o Are wash/rinse solutions being properly added and aspirated?
o Are cells being dried?
Roche Diagnostics
8 Check proper probe wash and cell wash programs are in place.
Erratic or biased test results
For problems with erratic or biased test results on the photometric unit, troubleshoot
1 Verify that the deionized water supply is free from contamination.
2 Check calibrators used on all units.
o Calibrators were not properly prepared. Repeat calibration with fresh
calibrator.
o Check calibrator preparation.
3 Information is not correct on Calibration > Install.
o Verify the calibration points on Calibration > Install and compare the
displayed data with the documentation for a specific test.
o Check that the calibration sample volume in the application parameters is
correct.
4 Check sample for fibrin clotting.
5 Ensure there is sufficient sample in the container. Check instrument
specifications for minimum sample volumes.
o Repeat analysis with appropriate sample volume.
Roche Diagnostics
Single sample or control
For problems with a single sample or control on the photometric unit, troubleshoot
1 Verify samples and controls are placed in the proper positions. If necessary,
correct the sample or control placement and rerun the sample.
2 Verify the control value ranges and lot numbers entered on QC > Install are
correct. If necessary, correct the control value range or lot number on QC >
Install.
3 Verify the sample and/or control volume is sufficient. Verify the selected sample
cup on Workplace > Test Selection.
4 Verify the sample integrity is acceptable (fibrin, lipemia, hemolysis, icterus). If
necessary, collect fresh sample and rerun.
5 Verify the appropriate sample type is selected (serum/plasma, CSF, urine,
supernatant, other) and the specimen was collected appropriately. If necessary,
correct the sample type; check the instructions for use in cobas link for acceptable
specimen types. Check the specimen collection; check the instructions for use in
cobas link for acceptable specimen collection methods.
6 Verify the collection time and date of the sample are correct. If necessary, collect
fresh sample.
7 Verify correct test selections were made on Workplace > Test Selection. If
necessary, correct any selections and rerun the sample.
Single test (1 reagent)
For repeated or consistent problems with a single test on the photometric unit,
troubleshoot according to the steps below:
1 Verify that reagents have not expired, or are not contaminated or discolored. If
necessary, insert a new cobas c pack.
2 Verify the correct calibrator code and setpoints are used. If necessary, correct the
calibrator code and setpoints and repeat the calibration.
3 Verify the special wash programming, if applicable.
Roche Diagnostics
Tests with more than 1 calibration point
For problems with tests with more than 1 calibration point on the photometric unit,
troubleshoot according to the steps below:
1 Verify calibrators were properly prepared and stored. If necessary, prepare new
calibrators and recalibrate.
2 Verify the assigned calibrators are in the correct positions. If necessary, place
calibrator(s) in correct position(s), recalibrate and rerun samples. Verify that
required diluents are on board.
Multiple photometric tests (more than 1 reagent)
For problems with multiple tests on the photometric unit, follow the steps below:
1 Verify there are sufficient volumes of special wash solutions and detergents. If
necessary, replace needed special wash solutions, detergent and rerun samples.
2 Check the reagent probe for barbs, obstructions or leaks.
3 Verify the reagent system is not leaking. Perform an air purge. If the system is
leaking, check connections in the reagent pipetter and check connections in the
reagent syringe.
4 Verify the incubation bath is free of debris and foam. If necessary, perform
incubation bath maintenance.
5 Perform a photometer check. Verify the Photometer Check report is within
acceptable limits (< 14000). If it is not, replace the photometer lamp. Perform a
cell blank. Calibrate all photometric tests.
Roche Diagnostics
All photometric tests
For problems with all photometric tests on the photometric unit, troubleshoot
1 Verify the sample probe is not blocked or does not have barbs at the tip. If
necessary, clean/replace the probe. Perform an air purge. Check proper dispense.
2 Verify the sample system is not leaking. If necessary, check tubings and
connections. Perform an air purge and check if there are air bubbles in the
syringe.
3 Verify controls/calibrators were properly prepared and stored. If necessary,
prepare new controls/calibrators.
5 Check photometer lamp.
Biased enzyme results
For problems with biased enzymes on the photometric unit, troubleshoot according
to the steps below:
1 Verify the incubation bath level is above the photometer lens.
2 Verify the incubation bath temperature displayed on the System Overview screen
is 37  0.1C. Verify there is no Incubation Bath Temperature alarm present.
If the temperature is out of range, perform an incubation water exchange, allow
the temperature to stabilize and recheck the bath temperature. If the temperature
is still unacceptable, call technical support.
3 Verify the sample and reagent syringe seals are in good condition. If necessary,
change the syringe seals.
4 Verify the syringe fittings are not loose. If necessary, correct any loose fittings.
5 Verify controls were prepared using volumetric pipettes. If not, prepare new
controls using a volumetric pipette.
6 Perform a full calibration or blank update.
7 Perform a Photometer Check. Verify the Photometer Check report is within
acceptable limit (< 14000). If not, replace the photometer lamp. Perform a cell
blank. Calibrate all photometric tests.
This is the last page of Part D.
Roche Diagnostics
Glossary E
cobas c 311 analyzer Glossary
absorbance (Abs) - calibration quality criteria
Glossary
This glossary is a compendium in which to look up the bichromatic measurement Photometric technique
meaning of technical terms used in conjunction with the measuring absorbance values at two different
cobas c 311 analyzer. wavelengths (primary and secondary wavelength).
A C
absorbance (Abs) The instrument displays an calculated result See calculated test.
absorbance by ten-thousandfold value.
calculated test A test result calculated from different
assay 1. A specific test. individual tests with a given formula such as ratio A/B.
2. A procedure where the concentration of an analyte in a
sample is determined. calibration The process that establishes the relation
between measured signals (e.g. from a photometer,
assigned value (Roche-defined) Roche-defined photomultiplier, or ion-selective electrodes) and
concentration for calibration material that is encoded on corresponding concentration values of a calibrator.
the calibrator barcode card or transfer sheet.
calibration curve A plot of measured signal values
Automated Download (ADL) A service that provides (determined during calibration) versus known
information necessary for analysis (such as analytical concentration values of calibrators.
parameters) from the data center. ADL is a cobas
TeleService application. See also cobas TeleService. calibration factor The reciprocal value of the slope
(K) of a calibration curve (only applicable to linear
automatic calibration 1. Automatic timeout calibrations). One of the factors used to create a
calibration. A calibration of a parameter performed if a calibration curve (S1Abs, K, A, B, C).
specified time interval expires. The calibration can be
defined for each method separately. calibration frequency A specified interval at which
2. Automatic calibration after a cassette or a cassette of a an assay should be calibrated. Also referred to as
new lot is registered. The calibration can be defined for calibration stability. It is implemented in the application
each method separately. parameters which are downloaded via cobas link.
3. Automatic calibration on QC failure. A calibration
request is generated by the system if a QC value is outside calibration function The type of calibration (for
a predefined range. example, Rodbard function, linear function, or cutoff
function). A mathematical model that describes the
automatic QC A quality-control function that relationship between a signal and a concentration in the
automatically samples QC material, test-specifically calibration curve. See calibration curve.
according to defined time intervals.
calibration masking A function that masks a reagent
automatic rerun The repetition, without operator when no valid calibration is available.
intervention, of tests that have results with data alarms.
calibration monitor A function that prints the
auxiliary reagent A non-test-specific reagent that is measured absorbance of the standard solution and the
needed to wash and rinse reaction cells, sample probes calibration factors, at the time of calibration, for every
and reagent probes. measurement item.
B calibration NOW A system-generated

recommendation to carry out calibration within a
barcode mode The operational mode when a system forthcoming defined time interval (Remaining Time on
is configured to operate using barcoded samples. Calibration > Status screen).
barcode type Typical sample barcode types used in calibration quality criteria Calibration checks
the IVD industry are Code39, NW7 (Codabar), ITF, and applied to the auto-validation of every calibration on the
Code 128. analyzer.
Roche Diagnostics
Operator’s Manual · Version 2.0 E-3
Glossary cobas c 311 analyzer
calibration trace - compensated test
calibration trace A graph used to review the check digit A verification number used in barcodes
measurements of the 50 most recent calibrations for a and software.
specific test.
check sum The result of a mathematical procedure to
calibration type 1. One of the following: Linear, RCM, validate the integrity of a set of data.
RCM2T1, RCM2T2, Spline, Line Graph. Each calibration
type corresponds to one specific type of mathematical circuit breaker See main circuit breaker.
function. See calibration function.
2. Lot calibration or cassette calibration. clot detection 1. A device built into the pipetting
system to detect clots and to avoid false pipetting.
calibration validation Analysis, performed by 2. The procedure of detecting a clot.
software, to check a calibration data set against specific
criteria. Calibration validation results are: successful or cobas The "umbrella brand name" for a broad range
failed. of products and services for use in professional IVD
laboratories and physician's office settings.
calibrator A material of known composition and
properties that can be presented to the analytical cobas c pack The name of the reagent cassette used
instrument for calibration purposes. on cobas c systems and COBAS INTEGRA systems.
COBAS INTEGRA cassettes can also be used on the
calibrator code The identification number of the cobas c 311 analyzer.
standard solution in calibration measurement.
cobas c pack MULTI The name given to an empty,
capacitance An electrical property that provides the but assembled and barcoded kit cassette that can be used
basis for liquid level detection in sample probes. The for Roche or non-Roche reagents. The word MULTI in
probes carry a high-frequency, low-voltage electrical this name stands for multi-purpose. The cobas c pack
charge. Frequency and electrical charge characteristics MULTI has to be assigned to a development channel
are altered and sensed when the probe touches liquid. application before loading it onto the analyzer.
carryover Contamination of a reaction mixture of one cobas link The infrastructure of network connections
assay by reagent(s) or sample material of another that enables cobas TeleService to exchange information
(previous) assay. between the Roche service network and a customer's
laboratory.
cassette The integrated reagent carrier consisting of
one or more reagent bottles and barcoded labels. The cobas link data station A dedicated desktop
term cassette, on cobas systems, is used generically to computer, located in the laboratory, that has been
refer to cobas c packs, cobas c pack MULTI, or COBAS configured to act as a gateway between Roche systems
INTEGRA cassettes. and the Internet. As well as providing a communication
link, the data station also stores data and documentation
cassette calibration Calibration data are specific to a for assay processing and can provide a data archive.
single cobas c pack. Most of the photometric tests need
to be calibrated only if the reagent lot is changed (lot cobas TeleService The set of software applications
calibration). See lot calibration. that use cobas link to exchange service information
between Roche service network and a customer's
cell blank The process of measuring the absorbance of laboratory. cobas TeleService provides remote
all reaction cells, filled with water, at all wavelengths. The monitoring and diagnosis, hotline support, and software
cell blank values are stored on the hard disk. By periodic and documentation updates.
cell blank measurement, reaction cells can be screened
for contamination or damage. Code39 A barcode type for sample tubes that can be
read by the barcode reader.
cell rinse unit A device for cleaning the reaction cells
with detergent and water and for dispensing and coefficient of variation A statistical measure used to
aspirating cell blank water. describe imprecision. Often abbreviated to CV.
cerebrospinal fluid (CSF) The fluid in the ventricles compensated test A test that has the result modified
of the brain, between the arachnoid and pia mater, and by a formula that takes account of known or defined
surrounding the spinal cord. interference factors.
Roche Diagnostics
E-4 Operator’s Manual · Version 2.0
Complete - dynamic range
Complete A system status found on several screens

D
indicating that all requested determinations have been
completed. data alarm Printed or displayed notification that
occurs if a result (including calibration or QC results) is
conditioning The process of letting serum-type liquid unexpected or abnormal; an indication of unusual
flow through the flow path before electrolyte reaction or instrument conditions, for example,
measurement. insufficient sample or reagent.
control ID The abbreviated name for a control data flag See data alarm.
material, for example PNU and PPU. Control IDs are
used on software screens and windows where limited dead volume See minimum sample volume.
space prevents the use of longer names.
default profile A predefined set of tests that the
control material A material of known composition analyzer automatically applies to a sample unless the
used to assess the performance of an analytical procedure operator specifies a different set of tests.
or part of an analytical procedure. Also called the control
sample. demographics Patient-related data such as name, date
of birth, and gender.
control name The name of a control material, for
example Precinorm Universal. development channel An open application where all
parameters must be set manually. Any non-standard
control SD value The acceptable variation SD value of reagents can be used but must be filled into the
a quality control sample. cobas c pack MULTI. A development channel
application has to be downloaded and installed via
control unit A computer by which an analytical system cobas link.
is controlled. The control unit also serves as the user
interface. deviation of duplicate measurements See
duplicate limit.
correction item A function that corrects the
measurement result of one item by using figures or the dilute waste solution A waste solution resulting after
measurement result of other tests. rinsing with water.
cumulative QC The accumulated data and associated dilution factor A software preset or manually assigned
statistics of individual QC data. dilution ratio that is used by the analyzer to perform a
requested dilution.
cup-on-tube The placement of a smaller secondary
sample container (for example a Hitachi Cup) on top of a disk position A dedicated position on the reagent or
primary sample tube. sample disk.
cycle The instrument time interval during which down time The period of non-operation between an
pipetting or measurement can be carried out. instrument failure and the resumption of operation.
cyclic QC Controls run at fixed intervals. dual value method A mode of expression of the
control chart in real-time quality control. For X-axis and
Y-axis, measure simultaneously the average and the
standard deviation of control of a low value and a high
value, and display them by X and Y coordinates,
respectively.
duplicate limit A calibration quality criterion. For a

successful calibration, duplicate measurements must be
within a specified limit.
dynamic range The reportable range of an assay. This

range extends from the lower detection limit to the limit
of linearity.
Roche Diagnostics
electromotive force (EMF) - ISE check
E H
electromotive force (EMF) The physical principle Hitergent 1. A detergent, with antibacterial properties,
that provides the basis for electrolyte measurement. The that can be added to the reaction bath where it acts as a
EMF is measured in millivolts surfactant, reducing the formation of foam.
2. A surfactant diluted for use in some cleaning
emergency stop An instrument alarm level that procedures.
immediately stops all instrument functions. See also E-
stopped. homogeneous immunoassay (HIA) An analytical
technique employing antigens and antibodies. An HIA
endpoint assay An analytical technique taking uses assay protocols similar to clinical chemistry without
measurements after a reaction is completed or has been a bound-free separation (for example, latex assays).
halted. See also rate assay.
Host communication Data exchange with a clinical
error handling A process during which the analyzer laboratory information system (LIS).
attempts to recover from an error condition. If the
analyzer cannot successfully recover from error, an alarm Host computer 1. A computer used for overall
is issued and the instrument is halted. management and control of the computer network.
2. A clinical laboratory computer that stores and
E-stopped A status indicating that the system has processes patient requests and results. A Host is able to
performed an emergency stop (E. Stop). This could be communicate with analytical instruments.
due to hardware failure or because any of the safety
devices have requested an emergency stop. The system Host interface protocol A technical description that
requires either complete power off, or at least defines data transfer between a Host computer and an
initialization, to resume normal operation. analytical system.
expected range The predefined range of test result

I
values expected for a defined group of healthy patients or
materials. Also known as "normal" range or "reference" ID reader Typically an optical device that reads the
range. identification code of a patient sample and transfers it to
the instrument database.
expected value A value for a test result that can be
considered as a "normal" result. increased volume rerun A rerun performed after
increasing the amount of sample used for the
expiration date Also called the expiry date. The end of determination.
a period until which Roche guarantees product claims for
its reagents, calibrators, and controls. incubation bath See reaction bath.
extended dynamic range The measuring range for Initialization The operational mode of an analyzer that
an assay at its highest dilution. occurs immediately after power on and during which the
instrument prepares itself for operation.
F instrument alarm A displayed alarm that indicates an
first registration The date and time when a reagent or unusual instrument condition such as an abnormal
sample was successfully recognized by the barcode reader reaction bath temperature or a mechanical malfunction.
for the very first time.
Instrument Manager Typically, PC-based software
functional sensitivity The concentration of an analyte that controls or supervises one or more analytical
at which a predefined level of imprecision is obtained. instruments.
internal standard solution (ISE IS) An internal

G
reference solution, assayed between every ISE sample,
global button A button that allows access to the global that compensates for electronic drift.
software screens and that can be used at any time.
ISE check A maintenance function for checking
whether electrolyte analysis can be performed correctly.
Roche Diagnostics
ISE drain port - Online Help
ISE drain port Port that discharges reaction waste manual rerun A retest function. Although a list of
from the ISE unit and collects it in a container. samples required for a rerun is created by following data
alarms, rerun is not carried out automatically. After
ISE Ref. See reference solution (ISE Ref.). organizing the rerun sample list, the operator directs the
rerun.
K
masking A function that temporarily suspends the
K factor A factor used in conversion of absorbance measurement or calibration of a specific test, depending
values to concentration values or activities. on the condition of the instrument or reagent.
L Material Safety Data Sheets (MSDS) Documents

that list components of chemical solutions and
liquid level detection (LLD) The ability of an precautions for the handling and disposal of the
analytical instrument to sense liquid by using the sample solutions.
or reagent probes.
measure point Time at which absorbance reading is
liquid waste container A reservoir for liquid waste taken and used to calculate results.
generated by an analyzer; its size and location vary
between instruments. measuring range See reportable range.
log file A set of data, typically stored in the control unit, Microcup A secondary sample cup made by Hitachi
that traces instrument-related or operator-related with a small dead (residual) volume.
activities such as maintenance.
minimum sample volume The sample volume that
lot calibration A mandatory calibration when a new must be present in a container to ensure faultless sample
lot of reagents is introduced to an analytical instrument. aspiration. Otherwise, a Sample Short alarm will occur.
The minimum sample volume depends on the size and
M shape of the sample container. Also called dead volume.
main circuit breaker Main power switch at the rear of Sample Cleaner 1 1 N NaOH solution for cleaning
the instrument. It controls the power supply of the entire the sample probe.
analyzer including the cooling unit (usually not switched
off).
N
maintenance item A maintenance procedure non-barcode mode A mode of instrument operation
performed by the system or the operator. in which the instrument identifies samples by sequence
numbers corresponding to their positions on the sample
maintenance key A button for position movement, disk.
used for a probe position check.
normal range See expected range.
maintenance pipe A combination of sequential
maintenance items programmed into a fully automated
procedure, which can be performed by the analyzer O
without operator intervention. on board 1. A technical device or function that is part
of the analytical instrument and can be used by the
maintenance procedure A procedure that must be instrument at any time.
performed on a regular basis (for example daily, weekly, 2. The availability of reagents and consumables on an
monthly, or every three months) to secure reliable analytical instrument for use at any time.
operation of the analyzer.
one-way serial processing Sample flow and
manual dilution An off-system, preanalytical step processing along a single, serial process lane that allows
performed by laboratory staff to reduce the analyte no bypass function and no rerun.
concentration in a sample.
Online Help On-screen documentation that a user can
request in a context-sensitive manner and search for any
given term.
Roche Diagnostics
online support - prozone
online support A service that supports the preparation post-analytical The sample management process,
for analysis and maintenance management by typically storage and archiving, after results have been
exchanging information over networks. See also cobas reported.
TeleService.
potentiometric assay An assay in which analytes (for
open request An ordered test that has not yet been example Na, K, or Cl) are measured in millivolts by ion-
performed or completed. Results for a sample may be selective electrodes.
partially available while some tests are not yet completed.
Power Up The system status while it is loading
Operate The operational mode during which the programs, performing self-checks, and so on.
instrument processes samples.
pre-analytical The sample management process
operator ID An alphanumeric ID that a system uses to before the analytical phase. Preanalytical processing
identify a particular operator. There are several levels typically involves actions such as sorting and aliquoting.
including operator, supervisor, and administrator.
precision The closeness of agreement between
order Also called a request. A test selected for a specific independent test results obtained under prescribed
sample or control. conditions.
order date/time A field used to maintain the arrival pre-dilution A dilution step performed before samples
date and time of an order in the laboratory. The are analytically processed on the analyzer.
date/time data may be entered manually or transmitted
by LIS protocols. preventive action A series of actions, suggested by the
system, that the operator should perform before daily
order ID The sample order identification refers to a operation to ensure sufficient inventory during the day
number of sample tubes (one or more specimen types) of (for example, the replenishment of reagents and
a given patient collected for a panel of different tests. consumables).
Typically, the sample order identification is printed on
order sheets. primary tube The original tube containing the sample
that has been drawn from the patient.
P
profile A user-defined set of test requests.
patient ID A set of alphanumeric data that
unmistakably identifies a particular patient. For example, protocol 1. A convention or standard that controls or
a social security number and a sample number. enables the connection, communication, and data
transfer between two computing end points. Protocols
photometric assay An assay in which analytes are can be implemented by hardware, software, or a
measured by a photometer. combination of the two.
2. A set of rules that guides how an activity must be
photometric window A window that enables light to performed.
pass from the light source lamp and into the reaction
bath. prozone The antigen/antibody complex formation is
predictable as long as an excess of reagent (antibody)
piercer A device that pierces the caps of a cobas c pack. exists. However, in patient samples with very high levels
of antigen, the reaction may begin to reverse
pinch valve A valve that pinches the suction tube and (deagglutination) because of the effect of the excess
switches the flow path. antigen. This is called a prozone effect, and without
checking for this phenomenon, abnormally high samples
pipe See maintenance pipe. may give incorrect or even false normal results. There are
two prozone check methods available: Antigen
pipetter A device used for pipetting (aspirating and readdition method and reaction rate method.
dispensing) a fixed amount of sample or reagent from a
sample or reagent container to reaction vessel.
plunger A rod that connects with the drive arm and

moves up or down, depending on the pipetting amount.
Roche Diagnostics
QC error - rinse bath
reagent prime A procedure that fills the ISE reagent

Q
lines and syringe with reagent.
QC error An alarm generated in realtime QC when
either a low value or a high value exceeds the limit of reagent probe Probe used to transfer reagents from
3 SD (QC error 1) or 2.5 SD (QC error 2). the reagent bottles to the reaction cells.
qualitative assay An assay that does not allow the reagent probe rinse station An area located between
determination of the concentration of an analyte, but the reagent disks and reaction disk where reagent probes
yields a classification of the sample, such as are rinsed both internally and externally with water.
reactive/nonreactive or positive/negative, with regard to
a certain analyte. realtime QC Real-time quality control. A method in
which two quality control samples of low and high values
quantitative assay An assay that allows the are measured, the quantitative values are judged in real
determination of the quantity (concentration or activity) time, and an alarm is generated if necessary.
of an analyte.
recalibration The repetition of a calibration.
query download A communication process between
instrument PC and LIS by which a predefined data set is reference electrode Electrode through which the
transmitted upon request of the analytical instrument. reference solution flows to provide a reference potential
for ISE measurements (also called reference cartridge).
R
reference solution (ISE Ref.) A KCl solution
random access The ability of an analytical instrument aspirated through the ISE reference cartridge. Also
to process requests from a patient sample in any order. known as ISE Ref. or reference electrode solution. See
reference electrode.
rate assay A determination in which measurements
are taken as the reaction proceeds. The rate of the reflex testing A request for additional testing based on
reaction is proportional to the sample component being customer-defined algorithms or rules and previous test
analyzed. Also known as a kinetic assay. results.
raw data The unprocessed values obtained during the repeat limit A user-definable limit at which a test is
analytical process on an instrument (for example mVolt run again under unchanged conditions.
or absorbance).
reportable range The range of results that can be
reaction bath A bath for keeping reaction cells at a reported for the assay. It stretches from the lower
defined temperature (37C). Also called incubation bath detection limit to the high end of the calibration curve.
or incubator bath.
request See order.
reaction cell A plastic cuvette into which sample and
reagents are pipetted for the chemical or immunological rerun The performance of the same test on a sample
reactions. again under changed conditions.
reaction disk A rotatable disk that holds the semi- rerun – concentrated The performance of the same
disposable reaction cells used for photometric test with a less diluted sample, either by decreasing the
measurement. diluent or by increasing the sample volume.
reagent compartment A temperature-controlled Reset Operational mode during which the analyzer sets
section on an analyzer that holds reagents and diluents. and aligns all mechanical parts to their home positions.
reagent disk The device in the reagent compartment Result Date/Time The instrument fills the result date
into which cobas c packs are placed. and time after the result calculation is finished. It may be
maintained by work area management systems for
reagent mask A function that automatically stops information purpose.
analysis of the current test when a required reagent is
empty or not present on the system. A red bar appears on rinse bath See rinse station.
the test key in the test selection screen.
Roche Diagnostics
rinse nozzle - STAT sample position
rinse nozzle A nozzle that supplies or drains detergent sampling stop An instrument alarm level that
or water used for rinsing reaction cells. indicates a problem with the sampling system. See also
S.Stop.
rinse station A technical device that cleans probes or
disposable tips with deionized water or cleaning secondary tube A sample container of variable size
solutions to avoid contamination and carryover. into which aliquots are transferred
Rodbard function A mathematical function used to sequence number When operating in non-barcode
convert measured signals into concentrations. It uses mode, samples are identified by a sequence number and
four parameters to define the shape and position of their position in the sample disk. This assignment has to
calibration curves. be done on the Workplace > Test Selection screen.
serum index A function by which the absorbance

S
characteristics of the samples are described to assess the
S.Stop Abbreviation for sampling stop. A system presence of lipemia, hemolysis, and icterus.
operating mode in which no new samples are pipetted,
but samples already pipetted will be completed without sipper A device to aspirate liquid from a vessel into a
interruption or loss. flow path, for example, ISE measuring flow path.
S1Abs The absorbance of standard solution 1. The Sleep mode Also called sleeping. A mechanical and
displayed value is 10000 times greater than the actual electrical status of an analytical instrument during which
measured absorbance. no immediate processing can be initiated by the
operator.
sample blank The absorbance of the sample plus
reagent 1 of a photometric test. The sample blank is SMS Selective Mode Solution, 0.2N HCl in a
subtracted from the actual absorbance reading to obtain cobas c pack for cleaning the reagent probe and in a
the absorbance value relevant for the result calculation. 70 mL bottle for cleaning the sample probe.
sample cleaner SmpCln 1 and SmpCln 2. See Sample Stand By An operational mode of the analyzer during
Cleaner 1 and SMS. which power is on but no sample analysis or
maintenance procedures are being performed.
sample cup A small container that is used for samples
and also for calibrator and control material. Sample cups standard Traceable reference material used to create a
can be inserted into 16-millimeter sample tubes (cup on (master) calibration curve. Also referred to as calibrator.
tube) or can be used without tubes. Compared to a
sample tube, a sample cup allows the use of smaller liquid standard deviation A statistic used as a measure of
volumes and so reduces the dead volume. the dispersion or variation in a distribution of data.
sample ID A set of alphanumeric data that standby reagent QC The measurement of a quality
unmistakably identifies a particular sample. See also control sample from a reagent that is on board the
patient ID. analyzer but not presently in use for routine testing.
sample probe Pipetter probe used to transfer sample Start up An operational mode of an analyzer, following
material from sample containers to reaction cells. power-on, during which the instrument prepares itself
for operation.
sample tube A glass or plastic container for liquid
samples to be used with the system. It may or may not STAT application A special test application (for
have a barcode label, which may be used for positive example, reduced incubation time) for STAT or
sample identification. A sample tube contains sample of emergency samples to achieve faster result reporting.
one specific specimen (sample) type.
STAT sample Emergency sample. Results will be
sample type One of four types of sample that can be available within shortest possible time.
analyzed: serum/plasma, urine, cerebrospinal fluid
(CSF), and supernatant. The sample volume and normal STAT sample position Reserved positions in the
value are settable for each type. sample disk for STAT samples, which will be processed
with priority.
Roche Diagnostics
Supernatant - water supply tube
Supernatant The usually clear liquid overlying

U
material deposited by settling, precipitation, or
centrifugation. ultrasonic mixer A mechanical unit, in a waterproof
pack, that generates ultrasound used to stir samples.
SysClean An auxiliary reagent used for the periodic
cleaning of the ISE unit. V
system error 1. A calibration quality criterion that validation The process of checking results or data
originates from a hardware failure while a calibration against defined rules or ranges in clinical laboratories.
measurement is performed. Validation can be against technical or clinical criteria.
2. The generic term for a case of instrument-related
problems. W
system reagent See auxiliary reagent. water supply tank A tank used to store deionized
water.
systematic error An error that is generated by a cause
giving deviation to measured values. An alarm generated water supply tube A tube for connecting a water
when control of a low value or a high value is changed in supply tank and an analyzer.
the same direction in realtime quality control.
T
target range The allowed range of recovery for an
analyte in a control material.
target value The mean of all participant responses

after removal of outlying values.
technical limit The dynamic range of an assay.
test code The abbreviated name for a test. This code is

displayed on test buttons shown on software screens or
windows.
test principle A technique that serves as the basis for

designing an assay to detect or quantify analytes.
test protocol The sequence of test steps used to

perform an assay (for example, volumes and timings).
timeout calibration An instrument mode that

automatically generates a calibration request after a
predefined interval.
timeout QC A function that measures the quality

control sample for the specified item at certain time
intervals.
turn-around-time 1. The time between the decision to

perform a test and the time when the doctor receives the
result and can act on it.
2. Inside the laboratory (Lab-TAT): Time between
receiving a sample and sending out the validated result.
Roche Diagnostics
water supply tube - water supply tube
Roche Diagnostics
Index F
cobas c 311 analyzer Index
Index
Symbols Application
– configuring, HbA1c, B–219
<Mix (data alarm), ISE unit, D–15 – installing HbA1c, B–219
<Mix (data alarm), photometric unit, D–25 – loading new application parameters, B–215
>Abs (data alarm), photometric unit, D–19 – troubleshooting, D–51
>Cuvet (data alarm), photometric unit, D–22 Application auto masking, B–225
>Index (data alarm), photometric unit, D–13, D–23 Application data, A–33
>Kin (data alarm), photometric unit, D–24 Application parameters
>Lin (data alarm), photometric unit, D–24 – description, B–221
>Proz (data alarm), photometric unit, D–26 – installation process, A–33
>React (data alarm), photometric unit, D–26 Application report name, B–229
>Rept / <Rept (data alarm) Application settings
– ISE unit, D–16 – autmatic rerun, B–229
– photometric unit, D–27 – auto masking, B–225
>Test (data alarm), ISE unit, D–17 – calibration timeouts, B–226
>Test / <Test (data alarm) – expected values, B–232
– ISE unit, D–18 – qualitative fields, B–231
– photometric unit, D–27 – repeat limit, B–230
– report name, B–229
Numerics – technical limit, B–230
Approvals, 3
3rd Results Acceptance, B–240 Approved parts, A–7
Archive
A – saving patient data, B–106
– saving system parameters, B–265
Abbreviations, 9 Areas of the analyzer, overview, A–24
Abnormal conditions, during operation, B–38 Assigning
Absorbance, reaction course, A–58 – barcoded samples to calibrator positions, B–130
Access – calibrator positions, B–175
– cannot access another software screen, D–57 – STAT positions, B–238
– no access due to operator level, B–9 – tests to units, B–248
– random access, E–9 Assignment
Access lamp for sample disk, A–37–A–38 – calibration curve, B–173
Accessory – Key setting window, B–244
– cobas c pack MULTI, B–133 – mandatory tests, B–51
– printer, A–30 – non-barcode mode, A–43
Accuracy/precision of measured results, A–6 – Test Assignment window, B–248
Activate AU, abbreviation, 9
– control, B–208 Auto masking, Utility > Application screen, B–225
– test, B–208 Automatic Printout, B–62, B–79
ADC.E (data alarm) Auxiliary reagents
– ISE unit, D–10 – for ISE applications, B–129
– photometric unit, D–20 – for photometric applications, B–132
Alarm – ISE applications, B–129
– check for, B–43 – overview, A–65
Alarm indication, D–7 – sample probe, A–37
Alarm levels, D–7
Alarm screen, reviewing, B–43
Analytical unit (analyzer), location, A–23
Roche Diagnostics
Operator’s Manual · Version 2.0 F-3
Index cobas c 311 analyzer
B Calibration
– Calibration > Calibrator screen, B–174
Backup – Calibration > Install screen, B–166
– Data files, D–53 – ISE unit, B–157
– overview, B–77 – load calibrator, B–176
– patient data, B–106 – request, B–60
– system parameters, B–265 – review data, B–159
– test results, B–77 – reviewing measurements, B–161
Backup function, A–32, A–34 – start-up calibration, B–158
Barcode – validating, B–63
– read error, B–103 Calibration > Calibrator screen, B–174
– scan range on sample containers, A–79 Calibration > Install screen, B–166
– specification of barcode types, A–78 Calibration and QC Load List
– specification of labels, A–79 – load calibrators and controls, B–61
Barcode reader – printing, B–60
– for cobas c packs, A–47, A–48 Calibration and QC Select, operation, B–58
– for samples, A–38 Calibration causes, B–152
Biased results Calibration error, ISE unit, D–28
– enzyme results, D–72 Calibration failure data
– troubleshooting, D–69 – ISE unit, D–11
Biohazardous materials, A–8 – photometric unit, D–20
Blood Calibration Load List report, B–61
– Whole > see HbA1c Calibration masking, B–155
Bubbles, in syringes, D–58 Calibration methods, B–153
Buttons Calibration timeouts, B–226
– global buttons, B–10 Calibration triggers, B–152
– software basics, B–19 Calibrator
– standard buttons, B–20 – assign position, B–175
– with black triangles and gray buttons, B–19 – for ISE applications, B–130
– load calibrator, B–61
C – measuring, B–62
– reassign calibrator values, B–172
Cal.E (Calib flag), ISE unit, D–28 Calibrator data, A–33
Cal.E (Sample flag) – loading, B–167
– photometric unit, D–20 Calling technical support, D–52
Cal.E (Sample flag), ISE unit, D–11 Carryover
Calc.? (data alarm) – auxiliary reagents, B–132
– ISE unit, D–10 – evasion, B–255
– photometric unit, D–20 – rinse station, A–40, A–46
Calculated test Cartridge
– program, B–250 – ISE measurement, A–61
– programming, B–249 – reference, A–61
Calculated test formula Caution, safety classification, A–5
– deleting, B–252 Cell blank, A–53
– entering, editing, B–250 Cell blank, abnormal (data alarm), D–22
Calculation Cell cleaners
– not possible (ISE unit), D–10 – See cell wash.
Cell covers, A–49
– cleaning, C–62
Cell detergents
– See cell wash.
Cell rinse unit, A–53
Roche Diagnostics
F-4 Operator’s Manual · Version 2.0
Cell wash cobas link

– clean aspiration filter, C–77 – backup function, A–32, A–34
– overview of solutions, B–132 – data station, A–31
– programming special washes, B–257 – e-barcodes, A–32
– replacement, B–141 – e-library, A–31, A–35
Changeover calibration, B–152 – e-package inserts, A–32, A–34
Characteristics, of the system, A–26 – Essential Information Upload, C–27
Check boxes, B–22 – loading application parameters, B–215
Checking – loading calibrator data, B–167
– abnormal sound, B–38 – loading control data, B–203
– alarms, B–43 – Overview, A–31
– calibration and QC results, B–63 – update process, A–32
– water leakages, B–38 Color scheme
Chloride – Alarm button, B–43
– ion-selective electrode, A–61 – QC Run Status screen, B–189
– low values, D–64 – Reagent Overview button, B–143
Circuit breakers and fuses, A–13 – Reagent Overview window, B–145
ClcT.E (data alarm) – status icons for units, B–9
– ISE unit, D–11 – System Overview screen, B–46
– photometric unit, D–21 – Test Review window, B–107
Cleaning – Test Selection matrix, B–89
– cell rinse nozzles, C–55 – Workflow Guide area, B–45
– detergent aspiration filters, C–76 Compensated test
– inlet water filter, C–110 – formula editing, B–254
– ISE drain port, C–57 – programming, B–253
– ISE Ref. aspiration filter, C–73 Compensation error
– ISE sipper, C–51 – calculation error (ISE unit), D–12
– probes, C–51 – data error (ISE unit), D–12
– radiator filter, C–80 Components
– reaction cells, C–68 – behind the front doors, A–64
– rinse stations, C–65 – control unit, A–28
– water tank, C–81 – ISE area, A–59
Cleaning solutions, overview, A–65 – overview, A–24
CmpT.? (data alarm) – reaction disk, A–49
– ISE unit, D–12 – reagent area, A–44
– photometric unit, D–21 – rear view, A–66
CmpT.E (data alarm) – sampling area, A–37
– ISE unit, D–12 Computer
– photometric unit, D–21 – control unit components, A–29
cobas c pack – troubleshooting, D–51
– loading of reagents, B–55 Cond.E (data alarm), ISE unit, D–29
– reagent loading station, A–47 Conditions, safety information, A–7
– Registration, B–136 Configuration
– scanning problems, B–56 – Module Set, B–247
cobas c pack MULTI, B–133 – report format, B–261
– Development Channel applications, B–213 – system configuration, B–235
– insufficient filling volume, B–55 Configuring
cobas e-library, A–34 – HbA1c application, B–219
COBAS INTEGRA cassette, A–47, B–133 Confirmation window, B–23
Confirmation window, open test requests, B–73
Contact addresses, 3
Containers (cups and tubes)
– on sample disk, A–42
– specifications, A–77
Roche Diagnostics
Contents tab Data files

– F1 Help, B–26 – Backup, D–53
– F1 Help, using, B–27 Data monitor report
Control – customizing patient reports, B–261
– activate, B–208 – monitor format, report format, B–264
– edit values, B–206 Data Print, operation, B–79
– load, B–61 Data problems without alarms, D–43
– measuring, B–62 Data Review screen, B–105
– request, B–60 Date format, B–147
– troubleshooting, Photometric unit, D–70 Dead volume, A–77
– validating, B–63 Decreased sample volume, D–47
Control data, A–33 Deionized water, water supply tube, A–66
– loading, B–203 Det.S (data alarm)
Control unit – photometric unit, D–23
– components, A–28 Detergents
– location, A–23 – cell wash, A–64
– specifications, A–73 – overview, A–65
Controls – sample probe, A–37
– reassign control values, B–207 Development Channel
Conventions used in this manual, 9 – description, B–213
Cooling fan, A–66 – Reagent Setting screen, B–139
– cleaning, C–112 Diluents for photometric tests, B–131
Cooling unit, A–64 Dilute waste line, A–66
– power switches, A–27 Dilution
– radiator filter, A–64, C–80 – automatic, B–97
Copyright, 2 – from Host, B–97
Cover – manual, B–97
– see top cover – prediluted sample, B–98
Cover, safety information, A–10 Dimensions, A–71
Cross contamination of samples, A–11 Disinfectant
Cross contamination, see Carryover – for cleaning instrument surfaces, C–134
CSF (cerebrospinal fluid), sample type, B–88 Disk column, Data Review screen, B–106
Cups and tubes, specifications, A–77 Disk position (codes N, E, C), B–106
Customer information, 8 Disposal, A–7
Cutouts, for the reagent probe, A–44 – of control unit components, A–20
– of the analyzer, A–20
D – of waste, A–10
Document information, 2
Daily Maintenance button, B–48 Download
Daily maintenance schedules, overview, C–34 – application data, A–33
Daily operation – calibration data, A–33
– check system alarms, B–43 – control data, A–33
– preroutine, B–48 – e-barcodes, A–32
– processing samples, B–66 – parameters, B–64
– start processing, B–68 Drying cylinder
– starting inspection, B–3, B–38 – reagent probe, A–45
– System Overview screen, B–44 – sample probe, A–40
– workflow, B–37 Dup.E (data alarm), photometric unit, D–30
Data Duplicate error, photometric unit, D–30
– archive patient data, B–106 DVD
– calibration, B–159 – Finalizing a DVD disk, B–125
Data alarms – Formatting a disk, B–123
– all listed, D–8 – Preparing a disk, B–122
– for controls, D–39 DVD drive, computer components, A–29
– ISE unit, D–10 DVD, specifications, A–73
– photometric unit, D–19
Roche Diagnostics
E Favorites tab
– F1 Help, B–30
E.Stop, B–41 Filters
e-barcodes, A–32 – detergent aspiration filters, C–76
– application data, A–33 – ISE Ref. aspiration filter, C–73
– calibrator data, A–33 – radiator filter, C–80
– control data, A–33 – water filter, C–110
Edited (data alarm) Finalizing a DVD disk, B–125
– ISE unit, D–12 Flow path
– photometric unit, D–23 – cleaning, C–47
Editing – ISE measuring system, A–61
– control values, B–206 Formatting a disk, B–123
– maintenance pipes, C–11 Fuses and circuit breakers, A–13
– maintenance types, C–19
Edition notice, 2 G
Electrical safety, A–8
Electrical supply, power not available, D–57 Gate, to the reagent loading station, A–44
Electromotive force, ISE analysis, A–62 GetLog file, D–53
e-library, A–31, A–35 Global buttons, B–10
– e-barcodes, A–32
– e-package inserts, A–32, A–34 H
– introduction, A–34
– user interface, A–35 H (data alarm)
Emergency stop, E–6 – ISE unit, D–13
Environmental conditions, A–72 – photometric unit, D–23
e-package inserts, A–32, A–34 Hard disk
Erratic result – control unit components, A–29
– ISE unit, D–60 – saving space on, B–50
– Photometric unit, D–68, D–69 HbA1c
Erroneous operation, D–43 – Calculation, B–220
Evaporation of samples, A–11 – Control data, B–220
Exclamation Point, Calibration Status screen, B–156 – Loading Application, B–217
Expected values Height adjusting lever, A–28, A–29
– changing, B–232 Help
Expected values, changing, B–232 – system, instrument, B–24
Expiration Date format, B–147 – See F1 Help
High result, Photometric unit, D–66
F High value
– ISE internal standard, D–63
F1 Help, B–24 – sodium, D–64
– areas in the help window, B–25 Hitachi cups, specifications, A–77
– buttons, B–25 Hitachi micro cup, A–42
– contents tab, B–27 Hitergent, A–51, B–132
– Favorites tab, B–30 Host interface, specifications, A–77
– index tab, B–27
– navigation, B–26 I
– printing topics, B–31
– search options, B–29 ICVC (initial cassette volume check)
– search recommendations, B–29 – registration of cobas c packs, B–136
– search tab, B–28 INC., abbreviation, 10
– searching for information, B–27 Increased sample volume, D–47
– topic area, B–26 Incubator bath, A–51
False bottom tube, A–42 Incubator bath, see also Reaction bath
– settings, B–246 Index tab, F1 Help, B–27
– specifications, A–77 Individual QC Chart window, B–191
Fatigue due to long hours of operation, A–11 Information, where to find, 7
Roche Diagnostics
Insoluble contaminants in samples, A–11 Loading

Inspection, before starting-up, B–38 – application parameters, B–215
Installation of the analyzer, A–6 – calibrator data, B–167
Installing – calibrators, B–61, B–176
– HbA1c application, B–219 – control data, B–203
Instrument – controls, B–61
– approvals, 3 – routine samples, B–67
– care, C–36 – STAT samples, B–70
– troubleshooting, D–56 Low results
Insufficient reagent alarm, ISE unit, D–16 – ISE unit, D–65
Interface port, A–30, A–77 – Photometric unit, D–67
Interface, Host (specifications), A–77 Low values
Internal standard, high/low values, D–63 – chloride, D–64
Interruption of measurement, B–69 – ISE internal standard, D–63
Intervals, for replacement of parts, C–45 – ISE unit, D–65
ISE
– auxiliary reagents, B–129 M
– drain port, A–66
– measuring system, A–61 M, status flag in Test Review window, B–90
– notes for replacement of reagents, B–130 Magnetic fields, A–28
– performing a reagent prime, B–54 Main components, overview, A–23
– replacing reagent bottles, B–52 Maintenance
– sipper mechanism, A–60 – checks, list of, C–28
ISE Calibration Monitor report, B–163 – general maintenance, C–5
ISE reagents – instrument care, C–36
– replacement of bottles, B–52 – maintenance types, adding and editing, C–19
ISE unit – overview, definitions, and concept, C–7
– calibration, B–157 – performing items and checks, C–9
– components, A–59 – preventive (periodic replacement), C–45
– erratic result, D–60 – recommended intervals, C–34
– flow of analysis, A–62 Maintenance items, C–24
– introduction, A–25 Maintenance mode, B–42
– low values, D–65 – to put the analyzer into, B–42
– reagent compartments, A–61 Maintenance pipe
ISE.E (data alarm), D–13 – defining, C–11
ISE.N (data alarm), D–14 – editing, C–11
IStd.E (data alarm), D–31 – pipe and pipe function, differences, C–10
– Power ON pipe, C–17
K – Power Up Pipe function, C–14
– recommended maintenance pipes, C–17
Keyboard, A–29 – Sleep pipe, C–17
– Sleep Pipe function, C–16
L – Start Up Pipe function, C–15
– Weekly pipe, C–18
L (data alarm) Maintenance schedules
– ISE unit, D–15 – brief description, C–36
– photometric unit, D–24 – overview, C–33, C–34
L, H, I (serum index), B–231 Maintenance switch, B–42
Light path, of photometer, A–52 Maintenance type
Liquid level detection – defining, C–19
– reagent probe, A–45 – editing, C–19
– sample probe, A–40 – indication on System Overview screen, B–48
List boxes, software basics, B–21 Maintenance works
Load list – cleaning instrument surfaces, C–134
– calibrator and QC load list, B–59 Markings, test selection matrix, B–90
– reagent load/unload list, B–51
Roche Diagnostics
Measurement Ordering information, 8

– start processing, B–68 Other, sample type, B–88
Measurement cartridges (ISE), A–61 Out of order
Measuring calibrators and controls, B–62 – instrument unused for an extended period of time, A–7
Mechanical problems, isolation, D–57 Over.E (data alarm)
Mechanical safety, A–10 – ISE unit, D–15
Menu tabs, software basics, B–17 – photometric unit, D–25
Minimum sample volume, A–77 Overview
Mix.E (data alarm) – areas and components, A–24
– ISE unit, D–15 – main components, A–23
– photometric unit, D–25
Modes, of the instrument P
– explanations, B–40
– maintenance schedules, C–35 P, abbreviation, 10
Module Set screen, B–247 Page button
Multiclean, B–132 – Utility menu, B–16
Parameter Download button, B–64
N Parameters, system, B–236
Pause/Scan (global button), B–10
NaOH-D, B–132 Periodic replacement of parts, C–45
Navigation pane Personal protective equipment, A–6
– F1 Help, B–26 Photometer, A–52
Non-barcode mode, A–43 Photometric Calibration Monitor report, B–159
Non-standard tube Photometric tests
– settings, B–246 – configuration, B–213
Notice, safety classification, A–5 – troubleshooting, D–72
Photometric unit
O – calibratin failure, D–20
– data alarm, Cal.E, D–20
Online help – flow of analysis, A–55
– F1 Help, B–24 – introduction, A–24
– instrument, B–24 – reaction course, A–58
Online Help system, 8, B–24 – specifications, A–75
Open test requests, B–112 Photometric unit troubleshooting, D–66
open test requests, B–73 – biased enzyme results, D–72
Operating conditions, A–7 – biased results, D–69
– electrical, A–71 – erratic results, D–68, D–69
– environmental, A–72 – high results, D–66
– water requirements, A–72 – low results, D–67
Operation – troubleshooting control, D–70
– overview, B–37 – troubleshooting sample, D–70
– preroutine operation, B–48 – troubleshooting single test, D–70
– preventive action, B–47 Piercer, for cobas c packs, A–45, A–48
– processing samples, B–66 Pinch valve
– safety information, B–3 – location, A–60
– start measurement, B–68 – replace tubing, ISE unit, C–96
– starting inspection, B–3, B–38 Pipetting priority, B–121
– System Overview screen, B–44 Pipetting volumes, ISE reagent, A–76
Operator Position
– qualifications, A–6 – assign barcoded samples to calibrator positions, B–130
– troubleshooting responsibility, D–51 – assign calibrators, B–175
Operator’s Manual – assign STAT positions, B–238
– conventions used, 9 Position Status
– find information, 7 – Sample Tracking window, B–72
– version, 2
Options, option buttons, B–23
Roche Diagnostics
Power ON QC results
– order for switching on the analyzer, order, B–39 – handling, B–182
– troubleshooting, D–56 Qualitative fields,
Power ON pipe, C–17 photometric application parameters, B–231
Power supply, specifications, A–71 Quality controls
Power switches, A–27 – for ISE applications, B–130
Power Up Pipe function, activating, C–14
Pre-diluted sample R
– requesting a test manually, B–91
Prediluted sample, B–98 R4SD (data alarm), D–40
– requesting a test manually, B–91 Radiator filter, A–64
Prep.E (data alarm), ISE unit, D–32 – cleaning, C–80
Preparing a disk, B–122 Random access, E–9
Preroutine operation, B–48 Random error, realtime QC, D–40
Preventive action Reaction bath, A–51, C–68
– check box, B–47 Reaction cell, A–49
– in daily routine, B–47 – rinse unit, A–53
Print Reaction course, of photometric analysis, A–58
– Automatic Printout, B–62, B–79 Reaction disk, A–49
– customizing report format, B–261 Reaction Monitor
– Data Print, B–79 – calibration measurements, B–161
– load list, B–59 Reaction system, specifications, A–74
– QC load list, B–187 Reag.S (data alarm), ISE unit, D–16
– reagent load/unload list, B–51 Reagent
– Report format, B–264 – barcode label of cobas c packs, B–134
– report name, B–229 – handling, B–135
– Requisition List, B–67 – ISE applications, B–129
Print order, B–261 – loading cobas c packs, A–47
Printer, A–30 – notes for replacement of ISE reagents, B–130
Printing – photometric applications, B–131
– help topic, B–31 – registration of cobas c packs, B–136
Printout – registration of ISE reagents, B–135
– Sample No. (S. No.), B–106 – replacement of ISE reagents, B–52
Priority, sample pipetting, B–121 Reagent area components, A–44
Processing Reagent cassettes
– reruns, B–95 – reagent compartment, A–44
– routine samples, B–66 Reagent compartment, A–44
– STAT samples, B–70 Reagent load/unload list
Programming – daily operation, B–51
– calculated tests, B–249, B–250 – printing, B–51
– compensated tests, B–253 Reagent loading station, A–47
– system parameters, B–236 Reagent management system, A–47
Reagent Overview window, B–143
Q Reagent pipetting system, A–45
Reagent Preparing button, B–51
Q2.5SD (data alarm), D–40 Reagent prime
Q3SD (data alarm), D–39 – for ISE reagents, B–54
QC Reagent probe, A–45
– request, B–60 – programming special washes, B–255
– validating, B–63 Reagent storage, location, A–44
QC error 1 (1-3S), D–39 Reagent syringe, A–46
QC error 2 (1-2.5S), D–40 – bubbles in, D–58
QC Load List report, B–61 Reagent system, specifications, A–75
QC points Reagent troubleshooting, photometric unit, D–70
– adding comments, B–192 ReagEx (data alarm), photometric unit, D–26
– excluding, individual points, B–192
Roche Diagnostics
Reassign Routine operation, B–65

– calibrator values, B–172 – workflow, B–37
– control values, B–207 Routine QC Assign, B–184
Recycling, of the analyzer, A–20 Rsp1.E (data alarm), ISE unit, D–33
Reference cartridge Rsp2.E (data alarm), ISE unit, D–33
– ISE measuring system components, A–61
– periodic replacement, C–119 S
Registration
– cobas c packs, B–136 S. Stop (global button), B–10
– ISE reagents, B–135 S.Stop, B–41
Relocation, A–7 S10Xa (data alarm), D–42
Repeat limit S10Xw (data alarm), D–42
– changing, B–230 S1A.E (data alarm), photometric unit, D–34
Repeat limit (data alarm) S2-2Sa (data alarm), D–40
– ISE unit, D–16 S2-2Sw (data alarm), D–41
– photometric unit, D–27 S4-1Sa (data alarm), D–41
Repeat Limit Flag, check box, B–241 S4-1Sw (data alarm), D–42
Replacement Safe and proper use of the analyzer, A–6
– cell detergents, B–141, C–77 Safety information
– ISE reagents, B–52 – classifications, A–5
– notes for ISE reagents, B–130 – for daily operation, B–3
– of ISE reagents, B–135 – for maintenance, C–3
– of parts, intervals, C–45 – general safety information, A–3
– sample probe detergent, B–142 – precautions, A–6
Report Samp.? (data alarm), photometric unit, D–27
– customize, B–261 Samp.C (data alarm)
Report format, B–261 – ISE unit, D–17
Report name, B–229 – photometric unit, D–27
Reproducibility, poor, D–44 Samp.S (data alarm)
Requesting – ISE unit, D–16
– calibrations, B–60 – photometric unit, D–27
– controls, B–60 Sample
– tests manually, B–91 – categories of samples, A–42
Rerun – detergent bottles, A–37
– automatic rerun settings, B–95 – identification, A–43
– decreased/increased volume, B–97 – loading routine samples, B–67
– diluted sample, B–97 – loading STAT samples, B–70
– introduction, B–95 – prediluted, B–98
– performing manual reruns, B–98 – priority, B–121
Result data – processing, B–66
– at high level, D–45 – processing additional samples, B–101
– at low level, D–45 – rerun, B–95
– drifting, D–43 – results, B–71
Results – tracking, B–72, B–111
– handle of QC results, B–182 – troubleshooting, Photometric unit, D–70
– printing individual, B–79 – tubes and cups, A–42
– ready for validation, B–71 – volume for rerun, D–47
Reuse, of the analyzer, A–20 Sample barcodes, unreadable, B–103
Review Alarm screen, B–43 Sample clogging (data alarm), D–17
Reviewing calibration measurements, B–161 Sample containers, A–42
Revision history, 2 – minimum sample volume, A–76
Rinse station – specifications, A–77
– cell rinse unit, A–53 Sample Data Clear, B–50
– cleaning, C–65 Sample detectors, A–38
– reagent probe rinse station, A–46 Sample disk, A–38
– sample probe rinse station, A–40 – barcode reader, A–39
Roche Diagnostics
Sample identification (barcode and non-barcode), A–43 Software

Sample No. (S. No.), printout, B–106 – cannot access screen, D–57
Sample pipetter, A–40 – general description, B–7
Sample probe, A–37, A–40 – main menu screens, B–11
– programming special washes, B–258 – version, 2
Sample Reception Mode, B–40 Software elements, B–17
Sample Reception mode, B–80 Software version, determining, C–28
Sample search, B–111 Sound volume adjustment knob, A–64
Sample status Sound, abnormal, B–38
– Data Review screen, B–71 Spare parts, for maintenance, C–45
Sample syringe Special wash, programming, B–255
– bubbles in, D–58 Specifications
– location, A–41 – barcode, A–78
Sample Tracking window, B–64, B–111 – basic specifications, A–26
Sampling area components, A–37 – detailed specifications, A–69
Sampling Pause, B–41 – sample containers, A–77
Sampling stop, B–80 Spillage, safety precaution, A–11
SBS mode, B–113 Stability Timer Reset, B–185
Screen Standard buttons, B–20
– accessibility, B–9 Standard cup, A–42
– general description, B–7 Standby
Screens, software basics, B–17 – with yellow background (maintenance mode), B–41
SD.E (data alarm), photometric unit, D–34 Start a run, B–68
Search tab Start Conditions screen, B–68
– F1 Help, B–28 Start Up Pipe function, activating, C–15
Searching Start, processing samples, B–68
– F1 Help, B–27 STAT
Selecting – positions, A–38
– items on touchscreen, A–29 – processing samples, B–70
– tests, B–66, B–70 – request test manually, B–91
Sens.E (data alarm), photometric unit, D–35 Status
Sensitivity error, D–35 – icon colors for units, B–9
Serum index Status line (top of screen), B–8
– check, B–231 Statuses, of the instrument
Shield pipe – explanations, B–40
– cleaning, C–52 – maintenance schedules, C–35
– location, A–40 Std, abbreviation, 10
Shortcut keys, B–32 Std.E (data alarm), ISE unit, D–37
Shutdown Std.E (data alarm), photometric unit, D–38
– analyzer, B–81 Stop (global button), B–10
– checks after, B–84 Stop button
– order for, B–83 – interruption of measurement, B–69
Shutdown status, B–41 Stop, sampling, B–80
Sleep mode, B–81, C–14 Supernatant, sample type, B–88
– entering, B–82 Surfaces
Sleep pipe, C–17 – cleaning, C–134
Sleep Pipe function, activating, C–16 Switching on the analyzer, B–39
Slop.E (data alarm), ISE unit, D–36 Symbols, 9
SMS, B–132 Syringes
Sodium – location, A–41
– high values, D–64 System interface port, A–30, A–77
– ion-selective electrode, A–61 System Overview screen, B–44
– color scheme, B–46
– color scheme, Workflow Guide, B–45
– preventive action, B–47
Roche Diagnostics
System parameters Troubleshooting

– how to program, B–236 – application, D–51
System reagents, see Auxiliary reagents – barcode read error, B–103
System specifications, A–71 – computer, D–51
– general, D–51
T – operator’s responsibility, D–51
– Photometric unit, D–66
Tabs – procedures, D–51
– software basics, B–18 – test, D–52
Technical limit Tubes and cups
– change, B–230 – description, A–42
– data alarm, photometric unit, D–18 – specifications, A–77
Technical support, calling, D–52
TeleService Net (TSN), cobas link, A–31 U
Test
– 3rd Results Acceptance, B–240 Ultrasonic mixer, A–50
– assigning a test, B–248 Unit of measure
– assigning to units, B–248 – defining and changing, B–228
– define automatic rerun, B–229 – for an application, B–228
– define report name, B–229 Unloading
– request manually, B–91 – cobas c pack, B–57
Test matrix, B–89 Unreadable sample barcodes, B–103
– markings, B–90 Updating
Test selection – application parameters, B–215
– downloaded from Host, B–66 User interface
– for STAT samples, B–70 – buttons, B–19
– manual selection, B–91 – general description, B–7
Test selection matrix – See also, Software.
– colors, B–89 Using Help system, 8
– overview, B–88 V
– test matrix, B–89
Text boxes, software basics, B–22 Vacuum pump and tank, A–64
Third-party software, A–7 Vacuum system, A–64
Tip water aspiration position, A–40 Validating
Top cover, A–51 – calibration, B–63
– description – QC, B–63
– instrument statuses, B–40 Value
– safety information for maintenance, C–3 – reassign calibrator values, B–172
– safety information for operation, B–3 – reassign control values, B–207
Touchscreen Values
– does not come on, D–58 – edit control values, B–206
– hard to see, D–58 – expected value ranges, B–232
Touchscreen monitor, A–29
Tracking samples, B–111 W
Trademarks, 2
Transportation, A–7 Wake-up time, C–14
Triangles on buttons, B–19 Warning, safety classification, A–5
Trouble Waste, A–9
– attributed to characteristics of reagent, D–45 – container for highly concentrated waste, A–66, C–38,
– for each test, D–46 C–43
Waste solution container, A–66
Water leakages, B–38
Water level sensor, reaction disk, A–49, A–50
Water requirements, A–72
Roche Diagnostics
Water supply, A–64

– tank, A–64
– tube, A–66
Wavelengths, photometric measuring system, A–75
Weekly pipe, C–18
Whole blood > see HbA1c
Windows
– confirmation, B–23
– software basics, B–23
With Automatic Rerun, check box, B–241
Work Flow Guide
– color scheme, B–45
– guide through preventive action, B–47
Workplace menu
– Data Review screen, B–105
– Test Selection screen, B–88
Roche Diagnostics

Cobas C 311 Analyzer: Operator's Manual Software Version 01-04

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Cobas C 311 Analyzer: Operator's Manual Software Version 01-04

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cobas c 311 analyzer

Revision history Manual version Software version Revision date Changes

Copyright  2007-2010, Roche Diagnostics GmbH. All rights reserved.

Trademarks The following trademarks are acknowledged:

Complies with the IVD directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

Manufacturer Hitachi High-Technologies Corporation

Authorized Representative Roche Diagnostics GmbH

Document information 2 6 Daily operation

5 Software basics 11 Configuration

12 Safety information for maintenance

14 Maintenance of the analyzer

The cobas c 311 analyzer is an automated, software-controlled analyzer for clinical

Where to find information

COBI CD The COBI CD (Compendium of Background Information) provides you with

Online help system

Conventions used in this manual

Symbols The following symbols are used:

Symbol Used for

Abbreviations The following abbreviations are used:

1 General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

General safety information

In this chapter Chapter 1

This section explains how precautionary information is presented in this manual.

e For more information about the product safety labels, see

Important information which is not safety relevant is indicated by the following

Operators are required to have a sound knowledge of relevant guidelines and

Safe and proper use of the analyzer

Installation o Installation must be performed by trained Roche service personnel only.

Miscellaneous safety precautions

List of warning messages

Electrical shock by electronic equipment

Infection by samples and associated materials

Infection and injury due to sharp objects

Reagents and other working solutions

Skin inflammation or injury caused by reagents and other working solutions

Infection by waste solution

Contamination of the environment due to inappropriate treatment of waste

e For information about disposal of the instrument, see

List of caution messages

Personal injury due to contact with moving parts

Reagents and other working solutions

Incorrect results due to incorrect reagent volume

Insoluble contaminants in samples

Incorrect results and interruption of analysis due to contaminated samples

Evaporation of samples or reagents

Incorrect results due to evaporation of samples or reagents

Cross contamination of samples

Incorrect results due to carryover

Fatigue due to long hours of operation

Fatigue due to long hours of operation

Malfunction due to spilled liquid

NOTICE List of notices

NOTICE Damage to the analyzer due to contact with moving parts

Circuit breakers and fuses

NOTICE Damage to the analyzer due to improper use

Safety labels of the system

Figure A-1 Front view of the analyzer

F-1 Warning: Possibility of infection or injury due to contact with

F-5 Warning: Possibility of electrical shock inside the instrument.

F-6 Warning: Possibility of infection due to contact with waste from

Figure A-2 Right side of the analyzer

S-1 Warning: Possibility of infection due to contact with waste