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Elecsys E411 Operator's Manual
Elecsys E411 Operator's Manual
Operators Manual
Software Version 01-01
Revision history
Manual Version Template Version Revision date Changes
1.0
Order numbers
Edition notice
3.0
Language
Order number
English
French
German
Italian
Portuguese
Spanish
Intended use
Copyrights
Trademarks
Instrument Approvals
The cobas e 411 analyzer meets the requirements of Directive 98/79/EC of the
European Parliament and the Council of the European Union (EU) on in vitro
diagnostic medical devices. Furthermore, the cobas e 411 analyzer is manufactured
and tested according to International Standard IEC 61010-1, 2nd edition, Safety
requirements for electrical equipment for measurement, control and laboratory use,
Part 1: General requirements. This International Standard is equivalent to the
national standards Underwriters Laboratories (UL) 61010-1 2nd edition for the USA,
and CAN/CSA C22.2 No. 61010-1:2004 for Canada. Compliance is demonstrated by
the following marks:
Roche Diagnostics
2
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the USA.
US
The purchase of this product allows the purchaser to use it solely for detection by ECL
Technology for human in vitro diagnostic uses. No general patent or other license of
any kind other than this specific right of use from purchase is granted hereby. This
product may not be used by purchaser to conduct life science research or
development, patient self-testing, drug discovery or development or in any veterinary,
food, water or environmental testing or use.
US Pat. 5,147,806; US Pat. 5,779,976; US Pat. 6,325,973; US Pat. 5,466,416; US Pat.
5,624,637; US Pat. 5,720,922; US Pat. 5,061,445; US Pat. 5,068,088; US Pat. 5,247,243;
US Pat. 5,296,191, and corresponding patents in other countries.
Contact addresses
Manufacturer
Authorized Representative
EC REP
Roche Diagnostics
Operators Manual Version 1.0
Roche Diagnostics
4
Table of contents
Revision history
Contact addresses
Table of contents
Preface
Where to find information
Online Help system
Customer information
Conventions used in this manual
System description
2
3
5
7
7
8
9
9
Part A
1 Safety information
Safety classifications
Safety precautions
System safety labels
A-5
A-5
A-18
2 System overview
A-27
A-30
A-30
A-34
A-34
A-37
3 Control unit
Components
Software basics
A-55
A-60
Overview
B-93
How to apply barcode labels to tubes and vials B-94
How to upload results manually
B-96
How to select two or more samples in Data Review
B-98
How to archive sample data
B-99
How to rerun a sample
B-100
How to reset the system
B-101
How to delete a single open request
B-103
How to assign calibrator and control positions B-104
How to install and define Roche controls
B-106
How to install and define non-Roche controls B-107
How to edit control values
B-109
How to request standby bottle QC
B-110
How to cancel a print job
B-111
How to print a daily Alarm Trace report
B-112
How to print a System Communication Trace report
B-113
How to change documentation settings
B-114
How to program calculated tests
B-115
How to change test settings
B-116
How to change calibration settings
B-118
How to change the sample disk mode
B-119
Maintenance
Part C
8 Maintenance
4 Analyzer components
Operation
A-71
A-72
A-89
A-97
Part B
5 Overview
Operation Guide
Disk and rack systems
Software keyboard
B-5
B-5
B-5
6 Daily operation
Overview
Pre-start inspection
Pre-routine operation
Routine operation
Results
Post-operation data management
Daily maintenance
Switch off the analyzer
B-11
B-12
B-18
B-31
B-81
B-87
B-87
B-88
Overview
Maintenance schedule
Maintenance log
Daily maintenance
Weekly maintenance
Every two weeks maintenance
Every two months maintenance
As needed maintenance
Troubleshooting
C-5
C-8
C-9
C-12
C-15
C-19
C-24
C-30
Part D
9 Troubleshooting
Introduction
Alarms
Problem categories
Contacting Technical Support
Basic troubleshooting flow chart
Immunoassay troubleshooting
Instrument troubleshooting
Chemistry troubleshooting
D-5
D-5
D-5
D-8
D-10
D-11
D-14
D-24
Roche Diagnostics
Operators Manual Version 1.0
10 Data alarms
Introduction
List of data alarms
Data alarms
Data problems without an alarm
Instrument problems without an alarm
Appendix
D-33
D-34
D-36
D-48
D-49
Part E
11 Appendix
Glossary
Glossary
Index
Index
Notes
Part F
F-3
Part G
G-3
Part H
Roche Diagnostics
6
Preface
The Roche Diagnostics cobas e 411 analyzer is a fully automated, random-access,
software controlled system for immunoassay analysis. It is available as both a disk
system and a rack system. The differences between the two configurations are detailed
throughout this operator's manual.
The cobas e 411 analyzer was designed for both quantitative and qualitative in vitro
determinations using a wide variety of tests. Both disk and rack systems have a
throughput of approximately 85 tests per hour.
The cobas e 411 analyzer can be placed on a bench top, so saving space in the
laboratory environment. Handling of the system is easy; potential for manual errors is
reduced to a minimum. All assay reagent, calibrator, and control information is
automatically entered into the software through the use of barcodes.
The system consists of the analyzer, which performs all functions required for fully
automated sample and assay processing, and a control unit, which controls the
analyzer through the user software. This entirely automated process begins with the
recording of patient samplesprovided that they are in barcode labeled tubesup to
the electrochemiluminescence detection and results transmission.
Data transmission to and from the analyzer, results evaluation, documentation, and
quality control are performed automatically by the software. Also, the software is
responsible for the management of data between a connected Pre-Analytic Systems
Manager (PSM)(1) and the cobas e 411 analyzer. Several cobas analyzers can be
centrally controlled when integrated with the PSM.
This manual has detailed descriptions of cobas e 411 analyzer features and general
operational concepts, specification functions and use of controls, operating
techniques, emergency procedures, product labeling, and maintenance procedures.
Keep this manual in a safe place to ensure that it is not damaged and remains available for use.
The Operators Manual contains information about safety, hardware, and operating
the system, as well as maintenance and troubleshooting. A table of contents at the
beginning of the book and each chapter, and an index at the end of this book help you
to find information quickly.
Online Help
The online Help contains a detailed description of the software of the cobas e 411
analyzer. In addition to the software description, the whole Operators Manual is
included in the online Help. This makes it possible to retrieve information from both
online Help and Operators Manual using the search functions available for
electronically stored documents.
Roche Diagnostics
Operators Manual Version 1.0
Short Guide
COBI-CD
Also available with this manual is the Short Guide. This small document is designed
to complement your Operators Manual. The Short Guide tells you exactly what is
necessary to operate the analyzer, without the level of detail found in the Operators
Manual.
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 e 411 analyzer. The information can be read
and printed using Adobe Acrobat Reader.
You cannot use the COBI-CD on the cobas e 411 system because the COBI-CD
requires Adobe Acrobat Reader to be viewed correctly. Adobe Acrobat Reader is not
installed on the control unit and such third-party software must not be installed.
Roche Diagnostics
8
Customer information
Customer training
Contact your local Roche service representative for any questions or information
regarding cobas e 411 analyzer system training and training material.
Contact your local Roche service representative for further information regarding the
cobas e 411 analyzer system service agreement.
Ordering information
Used for
Procedural step
List item
Cross-reference
Call up of screen
Note
Caution
Warning
Biohazard
Disk system-specific
Rack system-specific
Roche Diagnostics
Operators Manual Version 1.0
Abbreviations
Definition
ANSI
CBT
CCITT
CE
Conformit Europenne
CLAS 2
CLIA
COBI-CD
CSA
dBA
DIL
diluent
EC
European Community
ECL
electrochemiluminescence
EMC
electromagnetic compatibility
EN
european standard
FIFO
HCFA
IEC
IVD
KVA
LDL
LIS
LLD
MSDS
NCCLS
PC/CC
ProCell/CleanCell
QC
quality control
Roche Diagnostics
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Abbreviation
Definition
SD
standard deviation
S/R
sample/reagent
SVGA
TPA
tripropylamine
UL
VDE
This manual includes examples of screens from the cobas e 411 analyzer software.
The equivalent screens might be different on your analyzer because the appearance of
a screen depends on the specific configuration of an instrument and on the access
level of the person operating it.
Roche Diagnostics
Operators Manual Version 1.0
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Roche Diagnostics
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System description
1 Safety information
Table of contents
Safety information
Before operating the cobas e 411 analyzer, it is essential that you read and understand
the warnings, cautions, and safety requirements contained in this manual.
The following safety precautions and instructions are intended for operators and also
for anyone responsible for the management of the analyzer.
In this chapter
Chapter
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Operators Manual Version 1.0
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1 Safety information
Table of contents
Roche Diagnostics
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1 Safety information
Safety classifications
Safety classifications
This section explains how precautionary information is formatted in the manual.
e Throughout this manual, safety icons are used to draw your attention to certain
information. You should familiarize yourself with the following symbols, stickers,
and icons: See System safety labels on page A-18.
Warning
Indicates a possibly hazardous situation which, if not avoided, may result in death or serious injury.
Caution
Indicates a possibly hazardous situation which, if not avoided, may result in slight or minor
injuries, or damage to equipment.
Biohazard
Indicates a possibly hazardous situation which, if not avoided, may result in infection.
Indicates a possibly hazardous situation which, if not avoided, may result in harm to your eyesight.
Safety precautions
Pay particular attention to each of the following safety precautions. If these safety
precautions are ignored, you may suffer serious or fatal injury.
Warnings
Air bubbles or films in system reagents
Perform a reagent prime after replacing the ProCell and CleanCell bottles back on the analyzer to
ensure that there are no air bubbles or films in the fluid system.
Application
This instrument is designed for clinical immunological test analysis using water-soluble samples
and reagents. Other analyses may not be applicable to this instrument. For clinical tests, the
instrument should be used under the management of a doctor or clinical inspector.
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1 Safety information
Safety precautions
Do not use bleach, SysClean, or alkaline disinfectant (pH > 9.5) to clean the liquid waste container.
If such solutions are mixed with the contents of the liquid waste container, this could cause
potentially harmful fumes.
Do not bend the microbead mixer during cleaning. If the microbead mixer is damaged it will have
to be replaced, as incorrect mixing may cause incorrect results.
The system must be in Standby or switched off before continuing with this operation.
Do not touch the System Reset or Reagent Scan buttons, or switch on the analyzer, while
changing the Clean-Liner.
If any of the instrument circuit breakers trip or fuses blow, contact your Roche service representative
before you try to operate the system again.
Do not touch the sample/reagent probe until the analyzer enters S.Stop status as damage to the
probe may result.
Take care not to damage the lower end of the sample/reagent probe during cleaning.
Avoid direct contact with reagents and cleaning solutions. Follow the package insert information for
Roche Diagnostics reagents and cleaning solutions. Direct contact with these solutions may result in
irritation or injury to the skin.
Correct use
Always follow the instructions in the Operators Manual, as failure to do so may result in a risk to
your safety. Ensure that the Operators Manual is easily accessible at all times.
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1 Safety information
Safety precautions
Do not open the detection unit cover or service cover while the main circuit breaker is On.
Otherwise, damage to the photomultiplier may result.
To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off)
position and the power cord must be removed. Rack systems are provided with more than one
power supply cord. All power supply cords must be removed to disconnect the equipment from the
mains power supply.
Disposal of ProCell
Do not dispose of undiluted ProCell together with any strong alkaline solution, for example
CleanCell.
Do not attempt to gain access to parts of the instrument marked with this label. Do not open the
back cover or attempt to work in any electronic compartment. As with any electronic equipment,
electric shock can occur. Installation, service, and repair must only be performed by authorized and
qualified personnel.
Do not open the cover of the photomultiplier tubes high voltage supply circuit board with the power
switch or circuit breaker turned On. Touching the board may cause death or severe injury.
Environmental conditions
This analyzer is approved for indoor use only. Refer to the system specifications in the System
overview chapter for details of the safe environmental operating conditions.
Flammables
Keep flammables away from the instrument when conducting maintenance or checks using alcohol.
When using isopropyl alcohol or ethanol on or around the instrument, use no more than 20 mL at a
time. Isopropyl alcohol and ethanol (70%) are flammable substances, and there is a danger of fire,
explosion, or burns.
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1 Safety information
Safety precautions
Always wear protective (chemical-resistant) gloves and safety glasses when handling cleaning
solutions. Roche Diagnostics cleaning solutions have corrosive properties. The handling of cleaning
solutions with bare hands may result in injury to your skin, and failure to wear suitable eye
protection may result in injury to your eyes.
Handling of reagents
Avoid direct contact with reagents. Direct contact may result in irritation or injury to the skin.
Refer to the labels on the reagent boxes for specific handling instructions.
Avoid direct contact with CleanCell. Direct contact may result in irritation or injury to the
skin. Refer to the Clean Cell box label for specific handling instructions.
Do not use reagents that are expired. Otherwise, inaccurate data may be obtained.
Do not store reagents at a temperature of less than 2C as the microbeads should not be frozen.
Before loading reagents on the analyzer, ensure that they contain no bubbles, foam, or films as
these may cause pipetting volume shortage and deterioration in measurement accuracy.
Importance of maintenance
Provide the system with proper maintenance and care to ensure consistent and accurate
functioning. Modifying or omitting the maintenance procedures may result in the loss of
performance or reliability of the system, which are the responsibility of the operator.
Impurities in samples
Ensure that samples contain no insoluble impurities when loading on the instrument. Insoluble
impurities such as fibrin, dust, or air bubbles in samples may cause pipetting volume shortage and
deterioration in measurement accuracy.
Only trained Roche Support personnel, or similarly qualified personnel supervised by authorized
service agents of Roche Diagnostics, are qualified to install, transport, and dispose of a cobas e 411
analyzer.
The customer is responsible for providing the necessary facilities. See the system specifications for
details of the necessary facilities with suitable environmental conditions.
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1 Safety information
Safety precautions
Instrument covers
Close the top cover before starting operation. Take care not to pinch your fingers or hand.
Keep all covers closed and in place while the instrument is operating.
When you close the rack sample cover, take care not to pinch your fingers or hand.
Follow the procedures in the Operators Manual when opening the top cover for maintenance
and checks.
Certain instrument problems may arise that the system does not monitor. If this is the case, no
alarm is issued to alert the operator. Erroneous control measurements provide an important
indicator of analyzer problems even when no alarms are issued. Such problems may include worn
parts, air leaks in the syringe system, or reagent contamination. 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 system or reporting erroneous test results.
It is sometimes necessary to manually assign a vial or other sample or calibrator container to a rack
or a specific sample disk position, for example, due to an unreadable barcode.
o
Ensure that the position is not already assigned before manually assigning a position.
Do not manually assign calibrator vials with barcodes to racks or sample disks.
Refer to the Operators Manual or online Help for more details on making manual assignments.
Moving parts
Do not touch moving parts when the instrument is operating, and do not wear loose garments or
jewelry that could catch in moving mechanisms. Otherwise, you may be injured or infected, or the
instrument may be damaged.
Do not touch any parts of the instrument other than those specified.
Otherwise, you may be injured or infected, the instrument may be damaged, or may stop running.
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1 Safety information
Safety precautions
Operator qualification
Do not perform operation and maintenance unless you have been trained by authorized Roche
Diagnostics personnel or processes. Carefully follow the procedures specified in the Operators
Manual for the operation and maintenance of the system. Leave maintenance that is not described
in the Operators Manual to trained Roche Technical Support personnel. Follow standard
laboratory practices, especially when working with biohazardous material.
The operator is responsible for taking all necessary precautions against hazards associated with the
use of clinical laboratory chemicals. Specific recommendations for each reagent used on the analyzer
are found on the box label, package insert, or product information sheet for each chemistry.
Material Safety Data Sheets (MSDS) are available for Roche Diagnostics reagents.
An incorrectly measured result may lead to an error in diagnosis, therefore posing danger to the
patient.
o
Check that quality control measurements are within the specified range before accepting the
sample results. The frequency of quality control depends upon the system settings and your local
legal requirements.
Do not use reagents, calibrators, or controls that are expired. Otherwise, inaccurate data may
be obtained.
Refer to package inserts for example assigned values and sample/control stability.
Do not detach the cover. Because racks are moving at a high speed beneath the cover, you may be
injured if you touch racks in the A-line and C-line during operation.
If you open the reagent rotor cover during operation, your fingers may be entangled in it and
cause you injury.
Roche Diagnostics
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1 Safety information
Safety precautions
When replacing the pinch valve tubing, take care to avoid contact with any residual liquid
remaining in the old tubing. The liquid that flows through this tubing comes from the measuring
cell and so is potentially biohazardous. Wear approved disposable gloves. If you get any of the liquid
on your skin, wash it off immediately, apply disinfectant according to your own laboratory
practices, and consult a physician.
Sample evaporation
If the sample has been on board for more than two hours, repeat the analysis with a fresh sample.
Evaporation of samples that have been on board for more than two hours may lead to false results.
Biohazards
Biohazardous materials
Material of human or animal origin, and material from tissue cultures or in vitro cultures, must be
treated as potentially biohazardous. Always wear suitable protective equipment such as approved
disposable gloves, a fluid-resistant laboratory coat, and safety goggles, when handling biohazardous
materials. Handle all biohazardous materials according to your facility's biohazard procedure.
The following materials must be treated as potentially biohazardous materials and handled
accordingly:
o
Everything that comes into contact with these potentially biohazardous materials, such as
syringes, tubes, waste containers, reservoirs, S/R probe, sipper probe, rinse stations, and sample
disk protective cover.
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1 Safety information
Safety precautions
Handling of waste
Contents of the waste solution reservoirs, and subsequently the water used to rinse the containers,
are all potentially biohazardous. Contact with waste solution may result in infection.
o
Handle all waste materials and mechanical components associated with the waste systems
according to your facility's biohazard procedures, and always wear adequate protective
equipment.
Immediately wash off with water any waste solution that comes into contact with your skin,
apply disinfectant according to your own laboratory practices, and consult a physician.
Dispose of waste according to the appropriate local regulations for handling biohazardous
waste.
If your system is installed with a direct drain option, follow all local, state, and federal
regulations for waste disposal.
Take special care when disposing ProCell and CleanCell, as these may produce toxic gases.
When pouring waste down the drain, run the faucet (tap) continuously to ensure the waste is
diluted with plenty of water.
Consult the reagent manufacturer for information on the concentrations of heavy metals and
other toxic constituents in each reagent.
Preventing infection
Always wear approved protective equipment when operating or maintaining this system.
Protective equipment should include (but not be limited to) approved protective gloves, a fluidresistant laboratory coat, and safety goggles.
Take extra care when working with protective gloves because these can be pierced or cut by
sharp edges, which can lead to infection.
When wiping probes, use several layers of gauze and wipe from the top down to reduce the risk
of puncturing your protective gloves or skin.
If any biohazardous material is spilled on the instrument, wipe it up immediately, wash off any
residual material, and apply disinfectant.
If you get any biohazardous material on your skin, wash it off immediately, apply disinfectant
according to your own laboratory practices, and consult a physician.
Cautions
Aluminum parts
Do not use an acidic or an alkaline solution to clean the system reagent compartment or incubator.
The compartment is made of aluminum and these solutions degrade the metal.
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1 Safety information
Safety precautions
Approved parts
Use only parts and devices approved by the manufacturer. Use of non-approved parts or devices
may result in instrument malfunction and incorrect results and may render the warranty null and
void.
Switch off the analyzer power before manually moving any motorized components. If power is on,
the motors are engaged and attempted movement may damage them.
Do not bend the probe during cleaning, as this can crimp it. Be careful not to damage the tip of the
probe. If the probe is damaged, it will have to be replaced.
Use only barcodes with check digits. Barcode scanning errors could potentially go undetected when
a check digit is not used.
When loading additional samples on the sample disk after testing has begun, do not place a new
sample in a position where measurement has not been completed for the sample previously assigned
there. Otherwise, the new sample will be measured rather than the registered sample.
Cooling fan
Avoid touching the cooling fan of the detection unit while the analyzer is operating. Otherwise,
personal injury may result. Do not touch the fan unless the circuit break of the analyzer is turned
Off.
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1 Safety information
Safety precautions
Data backup
If a momentary drop in power voltage occurs due to a power interruption or lightning, the control
unit of the instrument may become faulty or the system software, application software, or data may
be damaged. In addition, instrument malfunctions or operating errors may cause damage to result
data or assay parameters. To prevent such losses, be sure to back up result data and assay
parameters periodically.
Make sure that the incubator surface and its positions are dry or you may experience gripper
problems when you resume operation.
Electromagnetic devices
Do not operate the following devices in the same room where the system is installed:
o
Mobile/cellular telephones
Transceivers
Cordless telephones
Devices that emit electromagnetic radiation may cause the instrument to malfunction.
Verify that the light on the rack sampler is green before you add a new rack or tray to the A-Line or
remove a tray of processed samples from the C-Line while the analyzer is in operation. Otherwise,
the instrument may be damaged or operation may stop. Do not add or remove single AssayCups
and AssayTips to a tray when it is on the analyzer.
Verify that sampling has stopped before you load additional samples on the sample disk, remove
processed samples from the sample disk, or replace the sample disk while the analyzer is in
operation. When sampling has stopped, raise the sample disk cover before changing samples.
Otherwise, personal injury may result or the instrument may be damaged or operation may stop.
Be sure to load samples and reagents only into the specified positions on the instrument.
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1 Safety information
Safety precautions
When loading racks on the system from the STAT rack position, ensure the rack is inserted the right
way around.
Memory problems
If any message from the operating system indicates a problem with the Flash memory, contact your
Roche service representative.
Non-Roche controls
When measuring a non-Roche control, use only recommended sample tubes, cup-on-tube, or cupon-rack. Do not use the Roche control vials, as the system would register this as cup-on-tube and
would not be able to pipette the control material.
Organic solvents
Do not use organic solvents on the AssayCups, AssayTips, and waste solution flow path, as these
parts are not guaranteed to be chemically resistant against organic solvents.
Do not use organic solvents, other than isopropyl alcohol or ethanol, for maintenance and
checkup.
Photosensors
Take care not to scratch or smear the photosensors in compartment positions 2 and 3.
The sensors are rectangular windows located at the back of the compartment, just below the top
edge. These sensors check for the presence of a ProCell/CleanCell bottle set.
Power interruption
Roche recommends that an uninterruptible power supply be used with this equipment. A
momentary voltage drop or surge caused by power interruption or lightning may damage the
control section of this instrument or corrupt the system software, application software, or data.
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1 Safety information
Safety precautions
Reagent rotor
Do not touch the reagent rotor or the reagent cover during operation. Otherwise, the
instrument may be damaged, or may stop running.
Do not insert your fingers into the openings in the reagent rotor cover or into the opening of the
reagent cap open/close mechanism. Otherwise, personal injury may result.
Check that the reagent rotor cover is locked on the reagent disk during operation unless you are
exchanging reagents. If the cover is kept open, the cooling efficiency and temperature control
may be compromised and the reagents may deteriorate. Opening the cover during analysis also
causes an instrument alarm and stops the instrument operation.
A reduced residual volume may only be used with Hitachi standard cups (not with primary or
secondary tubes).
Restrictions on samples
Do not use sample and cleaning or disinfectant solutions that are likely to adhere to the sample
probe, reagent probes, or measuring channel.
Make sure that you lay down the sample disk protective cover before you start operation.
Sipper shield
To open the sipper shield, push the white metal area at the top to release the latch. Do not pull
the sipper shield without releasing the latch in this way, otherwise the latch may be damaged.
Do not open the sipper shield while the analyzer is in operation, otherwise the analyzer will
immediately stop processing and an alarm will be issued.
Close the sipper shield after replacing a system reagent or performing maintenance, otherwise
the instrument will not operate.
Spillage
Wipe up any liquid spilled on the instrument immediately. Liquid spilled on the instrument may
cause it to malfunction. Do not place any liquid on the analyzer except where recommended or
requested in the Operators Manual or online Help.
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1 Safety information
Safety precautions
Stop processing
Choosing the Stop button causes all sampling and sample processing to be stopped. Results from
samples currently being processed are lost.
After switching off the analyzer, wait for at least ten seconds before switching on again.
Third-party software
Do not install any third-party software products on the instruments control unit. Installing thirdparty software may result in incorrect behavior of the system. The installation and use on the
instruments control unit of any third-party software is not approved or permitted by the
manufacturer. Installing third-party software may invalidate your warranty.
Do not crimp the replacement pinch tubing or damage the fittings during this operation.
Use of microcups
Take a rest for 10 to 15 minutes every hour to relax your eyes and body. Avoid spending more than
six hours per day looking at the monitor screen. Looking at the screen over long periods may tire
your eyes or body.
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Analyzer unit
Warning
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1 Safety information
System safety labels
Figure A-1
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1 Safety information
Figure A-2
Roche Diagnostics
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1 Safety information
System safety labels
Figure A-3
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1 Safety information
Power supply
Electrical safety precautions
Do not attempt to gain access to parts of the instrument marked with this label. Do not open the
back cover or attempt to work in any electronic compartment. As with any electronic equipment,
electric shock can occur. Installation, service, and repair must only be performed by authorized and
qualified personnel.
To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off)
position and the power cord must be removed. Rack systems are provided with more than one
power supply cord. All power supply cords must be removed to disconnect the equipment from the
mains power supply.
Circuit breaker
The following figure shows the circuit breaker and power cord.
Figure A-4
Roche Diagnostics
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1 Safety information
System safety labels
Figure A-5
Use only parts and devices approved by the manufacturer. Use of non-approved parts or devices
may result in instrument malfunction and incorrect results and may render the warranty null and
void.
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1 Safety information
Roche Diagnostics
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2 System overview
Table of contents
System overview
This chapter provides an overview of the cobas e 411 analyzer system, system
specifications, and product labeling.
In this chapter
Chapter
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Table of contents
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2 System overview
Overview of the cobas e 411 analyzer
Easy operation by means of a color touchscreen. Very few manual entries are
required.
Real-time monitoring of the analyzer allows the system to run unattended. Alarm
messages notify the operator of any problems.
STAT (Short Turn Around Time) samples are prioritized and processed as soon as
possible as the first priority, once the current operation has been completed.
Reagents are kept at a constant temperature (20 3C) on the analyzer, allowing
on-analyzer storage.
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Overview of the cobas e 411 analyzer
Disk system
The following figure shows a cobas e 411 analyzer disk system:
Figure A-6
Rack system
The following figure shows a cobas e 411 analyzer rack system:
Figure A-7
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System components
System components
This chapter provides an overview of the following main components and functional
areas:
o
Analyzer unit
Control unit
Power components
Analyzer unit
The analyzer unit on the disk system consists of the:
o
Sample/reagent area
Consumables area
Measuring area
Operation switch
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Analyzer unit
Operation switch
Figure A-8
C
B
Sample/reagent area
D
C
Measuring area
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Analyzer unit
Rack sampler
Operation switch
Reagent area
Measuring area
Figure A-9
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Analyzer unit
A
B
C
D
E
C-Line
B-Line (hidden)
A-Line
Figure A-10
Rack sampler
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Control unit
Control unit
The control unit is located at the top left of the analyzer and consists of the following
components:
o
Touchscreen monitor
Connections located on the left side for data storage, an external printer, and a
host interface.
Figure A-11
Control unit
Power components
The power components include the following:
o
Operation switch
Circuit breaker
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Power components
Operation switch
The operation switch is located on the lower left front side of the analyzer. Use the
operation switch to switch off the analyzer in order to perform certain maintenance
procedures or when the system is not in use for extended periods of time (for
example, overnight). The operation switch also switches off the power to the
touchscreen.
Provided that the circuit breaker is on, the reagent rotor and system reagent
compartment temperatures are maintained while the operation switch is off.
Operation switch
Figure A-12
Operation switch
Circuit breaker
The circuit breaker is located on the right side panel of the analyzer, above the power
supply cord. The circuit breaker controls the power supplied to the temperaturecontrolled reagent compartments when the operation switch is off. The circuit
breaker must be in the I (on) position whenever reagents are stored on the analyzer to
maintain liquid in the measuring cell.
When connecting or disconnecting the host cable, power the analyzer off at the circuit
breaker only.
For essential safety information, see Disconnecting the power supply on page A-7.
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Power components
Circuit breaker
Figure A-13
Power cord
Circuit breaker
For essential safety information, see Disconnecting the power supply on page A-7.
Figure A-14
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System specifications
System specifications
Technical data
A plate located on the right side of the analyzer displays the part number, serial
number, and power requirements.
The following figure shows an example of the analyzer plate.
Figure A-15
Instrument dimensions
The following table lists the dimensions of the cobas e 411 analyzer, for both the disk
and rack systems:
Analyzer
Height
Depth
Width
Weight
31.4 in(a)
80 cm(a)
(43 in, 109 cm with
top cover opened)
28.7 in
73 cm
47.2 in
120 cm
397 lbs
180 kg
31.4 in(a)
80 cm(a)
(43 in or109 cm
with top cover
opened)
37.4 in(b)
95 cm(b)
67 in
170 cm
551 lbs
250 kg
Instrument dimensions
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System specifications
Electrical
The following table lists the power requirements and heat output of the cobas e 411
analyzer:
Installation requirements:
Europe
220 to 240 V
Temperature rate
Whole length
Safety Standard
AC250V-10A /31.16AWG
Minimum 60C
250050 mm
CENELEC HD21
Supply voltage/frequency:
Power consumption:
1000 VA
Electrical specifications
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System specifications
Electrical specifications
Environmental conditions
The cobas e 411 analyzer is designed for indoor use only. The following table lists the
range of acceptable environmental conditions under which cobas e 411 analyzers will
reliably and accurately operate:
Temperature:
Operation: 18 to 32C
Storage and transport: -20 to 75C
Temperature variation:
Maximum 2C/h
Altitude:
Operation up to 2000 m
Table A-3
Environmental conditions
Noise level
The following table lists the acoustic noise levels generated by the cobas e 411
analyzer in various operating modes:
Noise level requirement:
Standby level:
60 dBA
63 dBA
70 dBA
Table A-4
Noise levels
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System specifications
Water supply
The following table lists the requirements for the water supply:
Water container:
3L
Water requirements:
Water consumption
(approximate):
Table A-5
Water supply
Liquid waste
Liquid waste container:
Table A-6
Liquid waste
The liquid waste container is not installed if the direct drain option is used.
Solid waste
Disposable solid waste container:
Table A-7
Solid waste
Throughput rate
Assay measurements:
Table A-8
Up to 86 tests/hour
Throughput rate
Sampling system
The following table lists the specifications for the sampling system. Certain capacities
vary between the disk and rack systems.
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System specifications
10 to 50 L
Sample/Reagent pipetter precision: For 10 L volumes, the coefficient of variance is < 1.2%
at an ambient temperature of 18 to 25C and < 2.4% at
an ambient temperature of 25 to 32C.
< 0.8% CV for 50 L volumes.
Sample detection:
Barcode symbologies:
PDF417
NW7 (Codabar)
Code 39
Code 128
Interleaved 2 of 5
Assay tips:
Assay cups:
Sample cups:
13 x 75 mm
16 x 75 mm
13 x 100 mm
16 x 100 mm
Table A-9
Sampling system
For essential safety information, see Check digits in barcodes on page A-13
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System specifications
Reduced
200 L
100 L
75 mm
200 L
150 L
100 mm
200 L
150 L
75 mm
600 L
100 mm
600 L
75 mm
1000 L
100 mm
1000 L
Calibrator/control vial:
Table A-10
(a)
150 L
(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials.
For essential safety information, see Reduced sample volume on page A-16.
Depending on sample volumes and type of vial (for example, primary sample tube or sample cup),
the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air aspiration.
Reduced
200 L
100 L
75 mm
200 L
100 L
100 mm
150 L
100 L
75 mm
600 L
100 mm
600 L
75 mm
1000 L
100 mm
1000 L
Calibrator/control vial:
Table A-11
(a)
150 L
(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials.
For essential safety information, see Reduced sample volume on page A-16.
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System specifications
Depending on sample volumes and type of vial (for example, primary sample tube or sample cup),
the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air aspiration.
Reagent system
Assay reagents
The following table lists the specifications for the assay reagents:
Reagent rotor temperature:
20C 3C
Reagent capacity:
R1/R2 consumption:
Microbead consumption:
Reagent detection:
Automatic dilution:
Evaporation protection:
Table A-12
System reagents
The following table lists the specifications for the system reagents:
Temperature:
28C 2C
Inventory control:
ProCell consumption:
CleanCell consumption:
Table A-13
Incubation system
The following table lists the specifications for the incubation system:
Incubator capacity:
32 AssayCups
Volume of AssayCups:
200 L
Incubation temperature:
37.0C 0.3C
Table A-14
Incubation system
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System specifications
Measuring system
The following table lists the specifications for the measuring system:
Measuring method:
Calibration mode:
2-point calibration
ProCell consumption
CleanCell consumption
Cycle time:
42 s
Temperature:
28C 2C
Table A-15
Measuring system
Control unit
The following table lists the specifications for the control unit:
Type:
Data storage:
System interfaces:
Host interface:
External printer:
Operating system
Table A-16
Control system
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System specifications
B
A
Figure A-16
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System specifications
Reagent packs
The following figure shows an example of a reagent pack (e-pack) used on the
cobas e 411 analyzer.
Figure A-17
Reagent pack
Each reagent pack is a single ready-to use unit that consists of three bottles:
o
The reagent pack and reagent rotor are keyed to prevent you from placing reagents on
the analyzer incorrectly.
Test number
Lot number
Instrument settings
Expiration date
Calibration frequency
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System specifications
A
B
C
D
E
F
G
H
I
Test code
Storage temperature
Expiration date
Figure A-18
Package inserts
Each reagent kit comes with a package insert, which provides detailed information
required to perform the assay. This information includes, but is not limited to:
o
Intended use
Test principle
Measuring range
Dilution
Expected values.
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Calibrator kits
For most tests, calibrators for the Elecsys reagents can be ordered separately (for
example, Elecsys FT3 or Troponin-T CalSet). Each kit contains barcoded calibrator
vials. Some calibrators are in a ready to use liquid form and require no further action
other than to place them on the sample disk or rack when a calibration is necessary.
A few of the calibrators are lyophilized in glass bottles and must be reconstituted
before being transferred into plastic barcode-labeled vials. (Empty barcode-labeled
vials are packaged in these kits with lyophilized calibrators.) You can store
reconstituted calibrators in the plastic vials after transfer.
Calibrators also have color-coded caps to assist you in identification. A level 1
calibrator has a white cap, and a level 2 calibrator has a black cap.
C
A
D
B
E
Package inserts
Calibrator kit
Each calibrator bottle has a traditional linear barcode label that contains an identifier
to link it to information encoded in the reagent barcode label and the calibrator
barcode card.
Each calibrator kit contains calibrator barcode cards.
e For further information, see Calibrator barcode cards on page A-49.
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System specifications
Test number
Expiration date
Roche Diagnostics produces a factory master calibration for each calibration lot. The
results are encoded into the corresponding reagent barcode. Scan the new barcode
card when you use a new lot.
e For additional information, refer to Reagent concept on the COBI-CD.
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Control kits
For most tests, controls for the Elecsys reagents come packaged separately (for
example, Elecsys PreciControl Universal). Each kit contains barcoded control vials for
use on the analyzer.
Most of the controls are lyophilized in glass bottles and must be reconstituted before
being transferred into plastic barcode-labeled vials. (Empty barcode-labeled vials are
packaged in these kits with lyophilized controls.) You can store reconstituted controls
in the plastic vials after transfer.
Controls also have color-coded caps to assist you in identification. A level 1 control
has a light brown cap and a level 2 control normally has a dark brown cap. Read the
package insert to check the color of the caps on the level 1 and level 2 controls.
Each control bottle has a traditional linear barcode label that contains an identifier to
link it to information encoded in the reagent barcode label and the control barcode
card.
Control barcode cards come packed in each control kit. These cards are described in
more detail in the next section.
A
B
C
D
F
G
controls
C
inserts
inserts
Package inserts
be kept separately
Figure A-20
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System specifications
Test number
Control ranges
Expiration date
Scan the new barcode cards when you use a a new control lot.
Figure A-21
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System specifications
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Table of contents
Control unit
This chapter provides a detailed description of the control unit and its components
and an overview of the system software.
In this chapter
Chapter
Components .................................................................................................................. 55
Touchscreen monitor .............................................................................................. 55
Software keyboard ................................................................................................... 56
Numeric keyboard ............................................................................................. 56
Full keyboard ..................................................................................................... 57
Keyboard transparency ..................................................................................... 57
Data storage ............................................................................................................ 58
External printer ....................................................................................................... 58
Service interface ....................................................................................................... 59
Host interface ........................................................................................................... 59
Software basics ............................................................................................................... 60
Status line ................................................................................................................. 61
Guidance prompt .................................................................................................... 61
Main menu screens .................................................................................................. 62
System Overview ............................................................................................... 62
Workplace .......................................................................................................... 62
Reagent ............................................................................................................... 62
Calibration ......................................................................................................... 63
QC ...................................................................................................................... 63
Utility ................................................................................................................. 63
Menu tabs ................................................................................................................ 63
List boxes .................................................................................................................. 63
Text boxes ................................................................................................................. 64
Options buttons ....................................................................................................... 64
Buttons ..................................................................................................................... 64
Standard buttons ............................................................................................... 64
Global buttons ................................................................................................... 65
Windows .................................................................................................................. 66
Selection menu for multiple items ......................................................................... 66
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Table of contents
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Components
Components
The control unit consists of the following components:
o
Software keyboard
Data storage
External printer
Service interface
Host interface
Touchscreen monitor
The 39 cm (15 in) color touchscreen monitor is located on the top left of the analyzer
and is used to:
o
Display information
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Components
Figure A-22
Touchscreen monitor
Software keyboard
The cobas e 411 analyzer software has an on-screen keyboard function. When you
touch a text box, a software keyboard pops up around the text box. The required
input determines whether the display is a full keyboard or numeric only.
Numeric keyboard
Full keyboard
mode button
Figure A-23
Transparency
button
Use the numeric keyboard to type numeric values, touching each field in turn to enter
the required values. When all the numeric entries are complete, choose Close to
return to the previous screen.
Choose the Full keyboard mode button (A) to switch from the numeric keyboard to
the full keyboard mode.
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Components
Full keyboard
A B
Transparency button
Figure A-24
Use the full keyboard to type alphabetical or numeric values, either touching the Tab
key or touching each field in turn to move between fields. You can either:
o
Move to the next text box either by choosing Tab or by touching the required box.
The software keyboard moves aside automatically from the selected text box.
Choose the Numeric keyboard mode button to switch from the full keyboard to the
numeric keyboard mode.
Keyboard transparency
You can control the transparency of the software keyboards by choosing the
Transparency button (B). This enables you to see what is behind the keyboard
without having to move or close it.
There are three transparency states:
o
No transparency (default)
Normal transparency
Increased transparency
Each time you choose the Transparency button, the transparency button will move to
the next transparency state.
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Components
Data storage
The system uses flash memory, memory cards, and CD-ROMs for data storage. There
is no mechanical hard drive; the Windows XP operating system is embedded.
The memory contains a number of data files necessary for the analyzer and the
software to work together. These files include the following:
o
Reagent data
O
Sample data
O
Up to 160 calibrators
QC data
O
Up to 2000 test records (for routine samples, STAT samples, and controls)
Calibration data
O
Up to 100 controls
Parameter data
O
Up to 20 operator IDs
Log data
O
The data CD-ROM contains read-only data, including assay reference tables
containing information that is linked to data encoded in the reagent barcode (for
example, test number, test code, available units, and unit conversion factors)
External printer
The instrument is designed to be used with one of the following printers:
o
Brother HL-2040
Canon LBP3000
The printers in the list above have been tested for use with the cobas e 411 analyzer and are
supported by Roche Diagnostics. You may be able to use an alternative USB printer that is not on
this list. However, Roche Diagnostics would be unable to provide support for use of any printer that
is not recommended for use with the cobas e 411 analyzer.
Connect the printer to the USB port marked PRINTER on the left side of the analyzer.
See the following figure for the location of this port.
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Components
Figure A-25
e For more information, see Reports in the Software description section of the online Help.
Service interface
The service port is used to connect an external storage device. This can be DVDRAM, or a removable USB service device if the data is to be backed up onto a PC.
Contact Roche Technical Support for information or assistance concerning the use of
this port.
Host interface
The instrument can be bidirectionally interfaced with a host.
Contact Roche Technical Support for information or assistance concerning the
interfacing of the cobas e 411 analyzer to the host.
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Software basics
Software basics
This section provides an overview of the system software, with a brief description of
the following screen elements:
o
Status line
Guidance prompt
Menu tabs
List boxes
Text boxes
Option buttons
Buttons
Windows
The main menus and online Help system are also described.
e For more information, see the Software description section of the online Help.
The screen representations shown in this chapter and throughout this manual are for illustrative
purposes only. The screens do not necessarily show valid results. Also, the availability and
appearance of any specific screen depends on the access level assigned to the operator.
The screen is divided into various areas. Some of these areas do not change, and some
differ according to the currently active function. Following is an example of a screen
showing the various areas.
C
A
Status line
Online Help
Global buttons
Figure A-26
Screen configuration
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Software basics
Status line
The status line is displayed across the top of each screen.
Figure A-27
Status line
The status line displays the current operational mode, operator ID, date, and time.
The double status icon on the left changes colors to reflect the current operational
status of the system. The color codes, listed from lowest to highest priority, are:
Icon
Color
Meaning.
Host
Blue
Green
Blue
Green
Yellow
Red
Table A-17
Choose the status icon at any time to display the System Overview screen.
Guidance prompt
The guidance prompt is shown in the lower left of each screen.
Guidance prompt
Figure A-28
In this area, the software explains how you can use a specific text box. When you select
a text box, the guidance prompt defines the information that you can enter. It may
also give an action to take, such as choosing a button or pressing a key.
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System Overview
Workplace
Reagent
Calibration
QC
Utility
Through these screens all instrument functions are controlled. Access to some
screens, especially those of the Utility menu, is confined to the access level of the user.
e For more information, see User access levels in the Software description section of the
online Help.
System Overview
The System Overview screen is the central screen used for performing daily operation.
From here you can view the status of reagents, calibrations, and quality control. You
can also check the quantities of consumables available on the analyzer.
The System Overview screen consists of the following areas:
o
Inventory area
e For more information, see System Overview screen in the Software description section of
Workplace
The Workplace menu screen consists of two main tabs: Test Selection and Data
Review.
o
Test Selection is used to enter and review test selections for a sample.
Data Review is used to search, review, backup, delete, and send data to the host.
e For more information, see Workplace menu in the Software description section of the
online Help.
Reagent
The Reagent menu screen is used to view detailed reagent and consumables
information.
e For more information, see Reagent menu in the Software description section of the online
Help.
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Calibration
The Calibration menu screen consists of three tabs: Status, Calibrator, and Install.
They are used to request calibrations, define calibrators, and view calibration results.
e For more information, see Calibration menu in the Software description section of the
online Help.
QC
The QC menu screen consists of six tabs: Status, Run Status, Individual, Cumulative,
Control, and Install. Use these screens to install, view and edit controls, and to
evaluate and accumulate quality control results.
e For more information, see QC menu in the Software description section of the online
Help.
Utility
The Utility menu screen consists of four tabs: System, Maintenance, Application, and
Calculated Test. These screens are used to enter system settings, application
parameters, and access maintenance and service functions.
e For more information, see Utility menu in the Software description section of the online
Help.
Menu tabs
You can use the menu tabs to select screens and windows that are grouped together
and used to perform related tasks. The menu tabs are accessible from every screen
(but not from popup windows). This makes the software navigation within the
menus, and between menus, very easy.
The menu tabs are for the five menus: Workplace, Reagent, Calibration, QC, and
Utility.
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.
Touchscreen: Choose the item within the list box on the screen by touching it. If a
scroll bar is displayed next to the list box, you can 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 to view the available item choices.
Software Keyboard: You can use the Arrow keys to move quickly through the list by
pressing the Arrow key that points in the required direction. The currently selected
choice is indicated by the selection cursor, which appears as a highlight. You can also
use the Home, End, Page Up, and Page Down keys of the full software keyboard to
move through the list. When the required item is highlighted, press Enter.
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Text boxes
A text box provides a place for you to type information on a screen. Some text boxes
are read-only and used to display information. Other text boxes may be unavailable
for you to enter information if the content of the text box is appropriate for the
current mode or configuration.
Move to a text box by touching it on the screen to choose it. The full or numerical
software keyboard will be displayed, depending on the entry field.
After you have typed in a text box, press Enter or Tab, or just touch the next field, for
your information to be accepted. Press Tab (full keyboard only) or touch the required
field to move the cursor to the next text box or option button.
Options buttons
Option buttons are used to select a particular function. Sometimes when an option is
selected, other option buttons or text boxes become available.
Choose an option by touching it on the screen. An option is selected when the
corresponding option button is colored light blue. If it is dark blue, the option is not
selected.
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 tab
that is active.
The black triangle in the upper right-hand corner of a button indicates that choosing
this button displays another window. The black triangle in the lower left corner of a
button indicates that choosing this button performs the specified function and closes
the window.
Choose a button by touching it on the touchscreen.
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
Cancel
Choose this button to accept the changes and entries made in a window and to close
the window.
Choose this button to close the window without saving the changes and entries made
in a window
Yes
Choose this button to accept the changes made in a window, perform the action of
the window (for example, Delete), and close the window.
No
Choose this button to close the window without saving the changes made in a
window or without executing the function of the window (for example, Delete).
Close
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Save
Update
Page Buttons
Choose this button to save any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.
Choose this button to update any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.
Some screens have page buttons that can be used to display additional buttons to
display new screens. These page buttons are numbered (for example, x/3), to indicate
the page that you are on.
The page buttons only change the displayed buttons and not the entire appearance of the screen.
Global buttons
Use the global buttons to display screens that are used for specific functions. The
global buttons are accessible from every screen and are located on the right side of the
screen (except for the Help button which is located in the lower left corner of the
screen). The global buttons include: Stop, Logoff, S. Stop, Alarm, Print, Start, and
Help. The Stop, S. Stop, STAT Rack (rack systems only), and Start buttons are also the
system control buttons. You can select the global buttons using the touchscreen.
Global buttons
Figure A-29
Global buttons
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Windows
Windows containing additional information are displayed, overlaying part of
currently displayed screens or windows.
Windows function in a similar way to screens. Information in a window can be
entered or edited through list boxes, text boxes, and option buttons. Action buttons
are also available.
Confirmation Window
Many functions require confirmation before they are performed (for example,
Delete).
Confirmation windows are used to confirm these functions. Choose Yes to confirm
the function and to close the confirmation window, or choose No to close the
confirmation window without carrying out the function.
online Help.
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A
A
? Help button
Figure A-30
To view online Help, choose the ?Help button at the bottom left of the screen.
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Table of contents
Analyzer components
In this chapter
Chapter
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Table of contents
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Overview of the analyzer components
Sample disk
Rack sampler
Barcode reader
Reagent rotor
Microbead mixer
Gripper unit
Pipetting station
Incubator
Sipper probe
Sipper pipetter
Detection unit
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Barcode reader
Reagent rotor
Microbead mixer
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Sample/reagent area components
Sample disk
The sample disk has 30 positions for samples, calibrators, and controls. You may place
patient samples in either primary sample tubes or sample cups. Built-in adapters
allow intermixing of different-sized primary sample tubes.
e For details of sample tubes that may be used, see Sampling system on page A-40.
You may place sample cups [2 mL (Standard) Hitachi cups only] directly on the
sample disk or on top of 16 mm primary sample tubes.
Figure A-31
Sample disk
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Rack sampler
The rack sampler consists of an A-Line, B-Line, C-Line, and STAT (Short Turn
Around Time) rack position.
A-Line
Specimens are placed in five-position racks and are loaded onto a tray. Once a tray has
been loaded, you can add additional racks to the tray one at a time during operation,
provided the tray indication light is green (on). If the light is out (off), the pusher arm
is preparing to move. The pusher arm, which is located at the far left of the A-Line,
pushes the racks forward and onto the B-Line.
The A-Line shown in the following figure, holds a tray that accommodates 15 racks at
one time.
5 racks
Ouput
buffer
5 racks
A-Line
5 racks
5 racks
Input
buffer
STAT
tray
indication
light
Tray
Part 1
C-Line
tray
indication
light
Tray
Part 2
B-Line
Tray
Part 3
B
A
Figure A-32
Input buffer
The input buffer, shown in the following figure, has space for an additional five racks.
Therefore, added to the 15 racks on the A-Line, you can have a total of 20 racks
holding 100 specimens on board at any one time.
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Sample/reagent area components
Tray
Part 2
Tray
Part 1
Ouput
buffer
C-Line
tray
indication
light
5 racks
5 racks
5 racks
Input
buffer
A-Line
STAT
tray
indication
light
5 racks
B-Line
Tray
Part 3
Figure A-33
B-Line
The B-Line transports the racks to the rack barcode reader. Here each position in the
rack is scanned for a sample barcode. After the last position is scanned, the barcode
reader scans the rack ID. After the last specimen is sampled, the rack is transferred
through the output buffer onto the tray on the C-Line.
5 racks
Figure A-34
Output
buffer
5 racks
A-Line
5 racks
5 racks
Input
buffer
STAT
tray
indication
light
Tray
Part 1
C-Line
tray
indication
light
Tray
Part 2
B-Line
Tray
Part 3
Rack in B-Line
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Output buffer
Racks are off-loaded from the B-Line into the output buffer, shown in the following
figure. If there is no tray, up to five racks can enter the output buffer. At this point the
sampling procedure stops.
Tray
Part 1
Output
buffer
C-Line
tray
indication
light
5 racks
5 racks
A-Line
5 racks
5 racks
Input
buffer
STAT
tray
indication
light
Tray
Part 2
B-Line
Tray
Part 3
Figure A-35
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Sample/reagent area components
C-Line
When the sixth rack moves into the output buffer, a rack is pushed onto the tray on
the C-Line, shown in the following figure. You can remove the tray from the C-Line
any time the tray indication light is green (on). If the light is out (off), the system is
preparing to push a rack onto the C-Line tray.
Tray
Part 1
Output
buffer
C-Line
tray
indication
light
5 racks
5 racks
A-Line
5 racks
5 racks
Input
buffer
STAT
tray
indication
light
Tray
Part 2
B-Line
Tray
Part 3
A
A
Output buffer
Figure A-36
You cannot remove single racks from the C-Line; you must remove an entire tray at
one time. If you remove the tray, the system continues to push racks into the output
buffer. If the buffer fills and there is no tray, the analyzer issues an alarm and stops
sampling racks.
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Tray
Part 1
Output
buffer
C-Line
tray
indication
light
5 racks
5 racks
A-Line
5 racks
5 racks
Input
buffer
STAT
tray
indication
light
Tray
Part 2
B-Line
Tray
Part 3
A
A
STAT position
Figure A-37
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Sample/reagent area components
Racks
Sample cups, primary sample tubes, calibrator vials, or control vials are placed in
racks shown below. Each rack holds a maximum of five samples. Each tube slot
contains adapters that allow the rack to hold different sizes of primary sample tubes.
Each rack has a unique ID found on the barcode label on the back end of the rack.
This rack ID is read by the barcode reader and transferred to the system. It appears
both on the screens and on the reports.
A
A
Rack ID barcode
Figure A-38
C
B
Tray guide
Racks
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AssayTip
Figure A-39
Barcode readers
Sample barcode reader
The sample barcode reader is located toward the back wall of the analyzer.
During a sample scan, the barcode reader scans the information on the barcodelabeled primary sample tubes, calibrators, or controls and transmits it to the software.
During a reagent scan, the barcode reader rotates to the reagent rotor side to read the
two-dimensional barcode labels on the reagent packs.
e For further information, see Reagent barcode label on page A-46.
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Sample/reagent area components
e For additional information, refer to Reagent concept on the COBI-CD.
You can see the barcode reader on a rack system when the reagent rotor is removed.
To read barcode labels, the barcode reader rotates between the reagent rotor and the
barcode card reading station.
e For further information, see Barcode card reading station on page A-84.
on page A-83.
You can see the barcode reader on a disk system when either the sample disk or
reagent rotor is removed.
e For the location of the barcode reader on a disk system, see Figure A-40 (viewed from the
sample disk side) and Figure A-41 (viewed from the reagent rotor side).
To read barcode labels, the barcode reader rotates between the sample and reagent
rotors and the barcode card reading station.
e For further information, see Barcode card reading station on page A-84.
Figure A-40
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4 Analyzer components
Figure A-41
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Sample/reagent area components
NW7 (Codabar)
Code 39
Code 128
Interleaved 2 of 5
In addition to the barcode reader, there is also a sample sensor which detects whether
there is a tube available in the rack position.
Figure A-42
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4 Analyzer components
On a disk system, the barcode reading station is located between the sample disk and
reagent rotor.
Figure A-43
On a rack system, the barcode reading station is located to the back left of the reagent
rotor.
Figure A-44
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Sample/reagent area components
Reagent rotor
The reagent rotor contains 18 positions for assays, diluent, or pretreatment reagents.
These 18 positions can be used in any combination. There are restrictions on the
maximum number of each type of reagent that can be placed on the disk.
Figure A-45
Reagent rotor
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4 Analyzer components
Figure A-46
The reagent cap open/close mechanism is normally hidden beneath the cover of the reagent disk
and cannot be seen in use.
Microbead mixer
The mixer is used to mix the microbeads to ensure a homogeneous suspension before
aspiration. The mixer is located to the right of the reagent rotor. In its home position,
it occupies the space directly to the left of the S/R probe.
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Sample/reagent area components
Figure A-47
Microbead mixer
A
B
Figure A-48
Rinse station
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Sample/reagent pipetter
Figure A-49
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4 Analyzer components
Consumables area components
Gripper unit
One AssayTip tray holds up to 120 AssayTips, and one AssayCup tray holds up to 60
AssayCups. Therefore, a total of 360 AssayTips and 180 AssayCups can be placed on
the analyzer.
Figure A-50
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4 Analyzer components
Gripper unit
The gripper can move in three directions:
o
It is equipped with gripping fingers for gripping AssayTips or AssayCups. The gripper
takes an AssayTip from the AssayTip tray, or an AssayCup from the AssayCup tray,
and delivers it to the pipetting station. The gripper then moves the AssayCup to the
incubator, then to the aspiration station, and finally to the AssayCup disposal
opening.
During operation, the analyzer starts using AssayTips and AssayCups from tray 1,
position 1. As soon as tray 1 is empty, the analyzer starts using tray 2. As soon as tray
2 is empty, the analyzer continues with tray 3.
e For further information, see To replace AssayCup and AssayTip trays on page B-30.
z axis
D
y axis
x axis
A
Position 1
Position 2
Tray 3
Tray 2
Tray 1
Figure A-51
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Consumables area components
Pipetting station
A five-position pipetting station is located to the upper left of the incubator.
AssayCups and AssayTips are moved by the gripper to this location for sample
pipetting, reagent pipetting, sample dilution, and sample pretreatment.
The AssayTips are discarded at the AssayTip eject station at the far right of the station.
Positions 1 and 2 are used for AssayTips, and positions 3 and 4 are used to hold
AssayCups for dilution or pretreatment. The S/R probe pipettes samples and reagents
at position 5.
D
A
Figure A-52
Pipetting station
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Removing the system water container during operation causes the analyzer to enter P. Stop status.
Figure A-53
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4 Analyzer components
Consumables area components
Figure A-54
Tank inlet
Figure A-55
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4 Analyzer components
The tank can hold up to one Liter of waste solution, and the analyzer will enter S. Stop
mode when the liquid reaches a predetermined level. A tube extends from the right
side of the analyzer to the tank.
A
A
Drain port
Figure A-56
Flow stagnation, or leaks may occur if the drain tube is bent or pinched. Check the condition of the
drain tube every day.
Do not connect any extension to the drain tube. It may cause flow stagnation.
If the reserve tank gets full, the analyzer will enter S. Stop mode. Check if the drain tube is bent or
pinched, and ensure that it is correctly placed. If you cannot find the cause, or if the tube is clogged,
contact a Roche service representative. Do not try to unclog the drain tube.
Figure A-57
Figure A-57 shows two examples of correctly installed drain tubes, running
horizontally or sloping downwards. The tube must not be bent, pinched, placed
above the level of the drain port, or form a U-bend along any part of its course.
Hands shown in photos and illustrations in the Operators Manual and online Help are to be
considered as hands covered with approved disposable gloves.
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4 Analyzer components
Consumables area components
Figure A-58
The drain tube must not be placed as shown in the examples in Figure A-58. The tube
on the left runs upward from the drain port. The tube on the right is forming a Ubend. In both cases, flow stagnation will occur.
A
A
Incorrect
Figure A-59
Correct
Make sure that the end of the tube does not touch the liquid surface, as this may stop
the flow (see Figure A-59).
To prevent clogging in the flowpath, pour approximately 100mL distilled or deionized water into
the tank inlet after each day's operation. See Clean the Direct Drain Flowpath in the Maintenance
chapter.
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4 Analyzer components
Removing the solid waste tray during operation causes the analyzer to enter E. Stop status.
Figure A-60
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Measuring area components
Incubator
Sipper pipetter
Detector unit
The sipper probe aspirates the incubated reaction mixture into the detector unit for
determination of results.
Incubator
The incubator is maintained at a specific temperature (37.0C 0.3C) for the
reaction of the sample and the reagents that have been dispensed into an AssayCup.
The incubator has 32 positions.
When an assay is ready for measurement, the AssayCup is transferred by the gripper
to the aspiration station, and the sipper probe aspirates the reaction mixture for
measurement. The aspiration station, located in the lower right corner of the
incubator, is not temperature controlled.
A
A
Incubator positions
Figure A-61
Aspiration station
Incubator
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Figure A-62
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Measuring area components
Sipper pipetter
The sipper pipetter is located directly to the right of the sample/reagent pipetter,
behind the liquid waste container. It uses positive displacement of system water to
aspirate and dispense from the sipper probe.
Figure A-63
Sipper pipetter
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4 Analyzer components
CleanCell is the cleaning solution used to clean the measuring cell after
measurement. CleanCell bottles are identified by black caps.
Two bottles of each reagent are stored on the analyzer, temperature controlled at
28.0C 2.0C. The keyed shape of the reagent compartment ensures that the reagent
can only be placed in the proper position.
A transparent sipper shield is fitted to the pipetter area. The sipper shield must be
opened to gain access to the system reagent bottles. It is opened and closed by
applying pressure to the white metal area at the top until the latch is released or
engaged. The sipper shield should not be opened during operation, otherwise the
analyzer will immediately stop processing and an alarm will be issued.
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Measuring area components
FG
Bottle set 2
Bottle set 1
Photosensor
Figure A-64
When starting from Standby, the sipper probe always attempts to first use ProCell and
CleanCell from bottle set 1. If the quantity is insufficient, bottle set 2 is used. When
starting from S. Stop or R. Stop, the bottle set in use when the analyzer was previously
in operation is pipetted.
The analyzer can operate with just one bottle of ProCell and one bottle of CleanCell
reagent, but they must be placed together either as bottle set 1 or as bottle set 2.
Detector unit
The detector unit receives the incubated reaction mixture aspirated from the sipper
probe.
e Information on the detector unit measuring cell is provided on the COBI-CD.
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Operation
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
5 Overview
Table of contents
Overview
This chapter describes the Operation Guide, the disk and rack symbols, and the
software keyboard associated with the cobas e 411 analyzer.
In this chapter
Chapter
Roche Diagnostics
Operators Manual Version 1.0
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Table of contents
Roche Diagnostics
Operators Manual Version 1.0
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5 Overview
Operation Guide
Operation Guide
This Operation Guide contains quick reference procedures for operating the Roche
Diagnostics cobas e 411 Immunoassay Analyzer. This Operation Guide can be used
for training purposes. More detailed information can be found in the Reference
Guide, Software Guide and Users Guide.
In the Operation Guide, you will find:
o
Procedures for special tasks that are not usually part of the daily work flow.
Software keyboard
A software keyboard of the appropriate type is displayed on the touchscreen as
required. Depending on the type of input allowed, either numeric keys or a full
keyboard are displayed as required.
The figures below show both types of software keyboard.
Figure B-1
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Software keyboard
Figure B-2
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Table of contents
Daily operation
This chapter describes the everyday tasks that are required for running the
cobas e 411 analyzer. Common procedures that are performed as part of the daily
work flow are also described here.
In this chapter
Chapter
Overview ........................................................................................................................ 11
Pre-start inspection ....................................................................................................... 12
Check list for daily operation ................................................................................. 12
Switch the printer on .............................................................................................. 13
Switch the analyzer on ............................................................................................. 13
Check system alarms ............................................................................................... 17
Pre-routine operation ................................................................................................... 18
System Overview screen .......................................................................................... 18
Color scheme of the System Overview screen ........................................................ 19
Reagent overview ..................................................................................................... 19
Inventory area ................................................................................................... 20
Reagent Detail window .................................................................................... 21
Work Flow Guide .................................................................................................... 22
Maintenance ...................................................................................................... 22
Sample Data Clear ............................................................................................. 22
Reagent Load List .............................................................................................. 22
Calibration/QC Load List ................................................................................. 23
Replacing required reagents and consumables ...................................................... 23
Replacing reagent packs .................................................................................... 23
Replacing system reagents ................................................................................. 25
Checking the system water container ............................................................... 26
Checking the liquid waste container ................................................................ 27
Checking the external direct drain system (if fitted) ....................................... 29
Emptying the solid waste tray ........................................................................... 29
Replacing AssayCup and AssayTip trays .......................................................... 30
Routine operation ......................................................................................................... 31
Perform calibration and QC ................................................................................... 32
Prepare calibrators and controls ....................................................................... 32
Load calibrators and controls ........................................................................... 32
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Table of contents
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Table of contents
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Table of contents
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6 Daily operation
Overview
Overview
Daily operation encompasses the routine tasks that are required to prepare the
system, analyze samples and maintain the system. The layout of the System Overview
screen gives the operator an intuitive guide for the tasks required for routine
operation.
The sections in this chapter contain detailed descriptions explaining how to
accomplish various daily operational tasks. The following diagram gives an overview
of the daily operation process.
Pre-start inspection
Switch on
(Initialization and Standby)
Check alarm button
Pre-routine operation
Routine operation
Calibration and control
Rerun
Assigned
-----------------------------------------------------Results
Sampling Stop
(Finalization, Stop, and Standby)
Maintenance
Switch off
Additional maintenance
(a)
Figure B-3
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6 Daily operation
Pre-start inspection
Pre-start inspection
Before switching on, check the following aspects of the system:
o
The system water container is full of distilled water with SysWash added to a
dilution ratio of 100+1.
Probes and microbead mixer paddle are in good condition and not bent.
Pipetter syringes and associated tubing are free of bubbles and are not leaking
system water.
Startup procedures
(None)
m Switch on
(None)
m Log on
Logon screen
(None)
Alarm screen
(None)
(None)
(None)
(None)
(None)
m Request controls
(None)
(None)
(None)
Table B-1
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6 Daily operation
Pre-start inspection
Procedure
Sample Processing
(None)
m Start processing
Result evaluation
m Print reports
m Review results
Daily maintenance
(None)
Finalization window
m Switch off
Shutdown window
Table B-1
with several printer models. For further information, and a list of recommended printers,
see External printer on page A-58.
In normal operation, the monitor will remain powered for prolonged periods. To preserve the image
quality of the monitor, Roche recommends that you enable the screen saver.
Use the Utility > System screen to activate the screen saver.
When the system is switched on, it performs initialization before entering Standby
mode.
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6 Daily operation
Pre-start inspection
Figure B-4
A small green light on the switch lights when the system is on, and the Logon
screen is displayed while the system performs initialization. During initialization,
the mechanisms are reset to their home positions.
2 After initialization is complete, ensure that the screen displays a Standby status.
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6 Daily operation
Pre-start inspection
1 Open the sipper shield by pressing the white metal area at the top, as shown in the
following figure, until the latch is released.
Figure B-5
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6 Daily operation
Pre-start inspection
Figure B-6
3 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
Do not open the sipper shield during a run, as the action will interrupt the run.
Figure B-7
Logon window
2 Choose the Logon button on the window to log on and gain access to the software.
The Operator ID will be shown at the top of all screens, next to the date.
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Pre-start inspection
Figure B-8
Alarm screen
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Pre-routine operation
Pre-routine operation
Before you can start routine operation you must first prepare the system.
Figure B-9
The System Overview screen has a central role within the cobas e 411 analyzer
software. From here you have an overview of the whole system at any time. This
screen displays the status of each reagent, the details of the reagents loaded, and
details of the inventory. You can access other windows by choosing the corresponding
button or area of the screen. You can use the Work Flow Guide to prepare the system
for daily routine operation.
You can open the System Overview screen from any screen by choosing the double
status icon in the top left corner of the screen. The colors of the two halves of this icon
show you the status of the host communication and the analyzer.
Icon
Color
Meaning
Host
Blue
Green
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6 Daily operation
Pre-routine operation
Icon
Color
Meaning
Blue
Green
Yellow
An instrument alarm has been raised with a caution level. This could
mean the number of tests remaining for a reagent is less than the caution
level specified on the Reagent Level Check window.
Red
Maintenance
Color
Meaning
Blue
System ready
Yellow
Red
Blue
System ready
Yellow
Red
Blue
System ready
Yellow
Red
Blue
System ready
Yellow
Reagent overview
Figure B-10
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6 Daily operation
Pre-routine operation
Use the Reagent Overview area of the System Overview screen to view the status of the
consumables on board. Reagent Overview area consists of two sub-areas: the Reagent
area and the Inventory area.
Reagent Rotor Graphic
Outer block: QC
Choosing a position segment of the reagent rotor section displays the Reagent Detail
window, with details of the reagent loaded in the chosen position. The color of the
segments of the Reagent Rotor graphic indicate the status of reagents, calibrators, and
controls.
Active
Warning
Caution
Stand-by
The reagent pack has been used and is empty. There is still
reagent available in another reagent pack on the analyzer.
Free Pos.
Expired.
Valid
Requested
Failed
Valid
Requested
Violated
Expired.
Inventory area
This area displays the amount of system reagents, AssayCups, AssayTips, and solid
waste on the analyzer by means of seven bar-charts.
PC1/PC2
The blue bar indicates the amount of ProCell (PC) remaining, with a % figure below.
The PC1 column represents bottle 1 and PC2 bottle 2.
CC1/CC2
The blue bar indicates the amount of CleanCell (CC) remaining, with a % figure
below. The CC1 column represents bottle 1 and CC2 bottle 2.
Solid waste
Vessel
The gray bar indicates the amount of solid waste present in the solid waste container,
with the quantity displayed below (0=empty).
The blue bar indicates the amount of AssayCup trays remaining, with the quantity
displayed below.
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6 Daily operation
Pre-routine operation
Tip
The blue bar indicates the amount of AssayTip trays remaining, with the quantity
displayed below.
Figure B-11
Use this window to view detailed information about the reagent loaded in the
position selected in the Reagent area of the System Overview screen.
Test
Position
Reagent Type
Reagent Lot No.
Reagent Pack No.
Lot Expiration Date
First Registration Date and Time
No. of determinations
The short name of the test for which the reagent pack is used.
The position the reagent pack occupies in the reagent rotor.
The type of reagent used (for example, ASSAY).
The lot number of the current reagent pack.
The sequence number of the current reagent pack.
The expiration date of the current reagent pack lot.
The date and time that the current reagent pack was first registered by the system.
This column displays the number of determinations remaining for the corresponding
reagent.
The date of the last lot calibration of the current reagent pack.
The recommended date for the next lot calibration
The date of the last reagent pack calibration of the current reagent pack
The recommended date for the next reagent pack calibration
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6 Daily operation
Pre-routine operation
Figure B-12
The Work Flow Guide area consists of six buttons: Maintenance, Sample Data Clear,
Reagent Load List, Calib/QC Load List, Parameter Download, and Sample Tracking.
The color of each button varies, depending on the status. Choosing these buttons,
displays screens and windows that enable users to take actions appropriate to the
situation.
Maintenance
Use Maintenance on the System Overview screen to perform maintenance actions.
Choosing Maintenance displays the Maintenance screen.
Sample Data Clear
Choose Sample Data Clear when the button is red or yellow to display the Sample
Data Clear window.
Figure B-13
Use the Sample Data Clear button to delete the sample results. Sample Data Clear
deletes all records of the samples and moves QC data to the QC view. Regular backing
up is recommended. If your system is connected to a host, make sure that all data has
been uploaded before performing Sample Data Clear.
e See How to archive sample data on page B-99.
Sample clear
6 Daily operation
Pre-routine operation
You can also print a Reagent Load List from the Reagent tab of the Print global screen.
You can also print a Calibration/QC Load List from the Reagent tab of the Print global screen.
For essential safety information, see Replacing reagent packs on page A-10.
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6 Daily operation
Pre-routine operation
Figure B-14
2 Place the required reagents in the reagent rotor, ensuring that the reagent packs
are correctly oriented in the rotor.
Reagents on the reagent rotor are stored in temperature controlled conditions. If you plan to run
assays that currently are not stored on the analyzer, you must allow them to reach reagent rotor
temperature (20 3C) before starting analysis.
Figure B-15
3 Close the reagent rotor cover. The analyzer will not operate without the cover on
the disk.
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Pre-routine operation
The reagent rotor cover is keyed. It must be properly oriented, so that the cover fits into the key,
before it can be closed.
4 Choose Scan Reagent on the System Overview screen to activate a reagent scan.
When the reagent scan is complete, the reagent rotor indicator on the System
Overview screen is updated to displays the status of each reagent pack placed on
the reagent rotor.
Replacing system reagents
You must always replace ProCell and CleanCell bottles as sets. You must not exchange
them during a run.
e See System reagents (ProCell and CleanCell) on page A-100.
For essential safety information, see Replacing system reagents on page A-10.
2 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
e For the location of the sipper shield, see Figure B-5 on page B-15.
Always replace ProCell and CleanCell bottles as sets. If you remove and replace a full (100%
volume) bottle from one of the system reagent compartment positions containing a photosensor, the
analyzer assumes that you have loaded a new bottle set, even if the bottle has been on the analyzer
for several hours or days. The analyzer consequently waits 15 minutes for temperature
equilibration, as is normal for a new bottle set.
If you need to load two new bottle sets of ProCell/CleanCell, load these new bottles as your first
inventory check. By the time you are ready to operate, the system reagents should be at the correct
temperature. If they are not, you will receive ProCell/CleanCell reagent temperature alarms.
e For further information on these alarms, refer to Data alarms on page D-31.
The bottles on the right (Set 1) are consumed first. If replacing the bottles on the right, move the
bottles from the left (Set 2) to the right. Then load the new bottles in the correct positions of Set 2.
3 Remove the empty ProCell and CleanCell bottles, indicated in the inventory area
on the System Overview screen, and replace them with a set of full bottles. Ensure
that each bottle is firmly in place in the correct position with the correct
orientation. Place ProCell only in the left hand position of each bottle set and
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CleanCell in the right hand position. The keyed shapes of the reagent
compartment and reagent bottles ensure that the reagents are placed in the proper
position.
Bottle set 2
Bottle set 1
Figure B-16
4 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
5 Close the instrument cover.
6 If a ProCell bottle with a new lot number was loaded, select Reagent and choose
the Inventory Set button. The Inventory Set pop-up window is displayed. Here
you can type in the lot number for each of the ProCell and CleanCell.
For essential safety information, see Air bubbles or films in system reagents on page A-5
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6 Daily operation
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Figure B-17
page C-30.
For essential safety information, see Avoid use of bleach on page A-6.
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Figure B-18
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6 Daily operation
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For essential safety information, see Changing the Clean-Liner on page A-6.
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C
A
Sliding lid
Waste tray
Figure B-19
4 Remove the Clean-Liner from the tray and dispose of it according to the waste
procedures that apply in your laboratory for potentially biohazardous material.
5 Place a fresh Clean-Liner in the tray.
6 Verify that the sliding door is open and that the opening is located at the back of
the tray.
7 Insert the tray into the analyzer and close the door.
The counter for the solid waste, which is located on the System Overview screen,
automatically resets to zero (0) when the tray is removed.
If you remove the solid waste tray for any reason you should discard the solid waste or replace the
Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during the
course of operation. When the analyzer senses that the solid waste tray is removed, the counter
resets to 0 (zero), and starts counting as if the tray is empty.
1 Replace any empty AssayCup or AssayTip trays with full ones as required. Do not
add or remove single AssayTips or AssayCups.
2 Make sure that the trays are seated properly with the correct orientation. Trays are
keyed for proper placement.
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6 Daily operation
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Figure B-20
The level is checked and the inventory is automatically updated the next time the
system changes to another tray.
e For information on how you can also load AssayCups and AssayTips when the analyzer is
Routine operation
After completing pre-routine operation, you are ready to start routine operation.
Routine operation involves procedures related to the following areas:
o
Dilution
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6 Daily operation
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2 Use QC materials to verify calibration as well as the precision and accuracy of the
instrument. Follow the regulatory requirements for your local area to establish
additional control runs for your laboratory.
3 Load calibrators and controls onto the sample disk.
For essential safety information, see Manual assignment of sample containers on page A-9.
2 Use QC materials to verify calibration as well as the precision and accuracy of the
instrument. Follow the regulatory requirements for your local area to establish
additional control runs for your laboratory.
3 Load calibrators and controls onto the racks and place the racks on the loader.
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6 Daily operation
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e For more information, see:
For essential safety information, see Manual assignment of sample containers on page A-9.
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6 Daily operation
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2 Place the CalSet vials and control vials correctly in their keyed positions on the
sample disk, as shown in the following figure, with the barcode facing outward.
B
A
Keyed vial
Figure B-21
Keyed disk
3 Open each CalSet vial lid to the vertical position (see Figure B-22).
Load the racks and request calibration
a To load the rack
1 Place one CalSet (vials Cal1 and Cal2) of open, barcode-labeled calibrator vials on
the rack. Ensure that both levels of calibrators are next to each other on the rack.
When the calibrator barcode is scanned by the barcode reader, calibration is
automatically requested for the assay.
2 Place the CalSet vials and control vials correctly in their keyed positions on the
rack, with the barcode facing outward as shown in the following figure.
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6 Daily operation
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A
B
Keyed vial
Figure B-22
Keyed rack
3 Open each CalSet vial lid to the vertical position as shown above.
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Activate QC test
If a new control lot is loaded, you will need to activate the required tests.
a To activate or deactivate tests
1 Choose QC > Install.
Figure B-23
For essential safety information, see Instrument problems without alarms on page A-9.
For essential safety information, see Air bubbles or films in system reagents on page A-5.
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6 Daily operation
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For essential safety information, see Manual assignment of sample containers on page A-9.
Figure B-24
2 If the analyzer is running in the multiple sample disk mode, make sure that the
number in the Disk No. box reflects the sample disk currently loaded. Correct the
number if necessary.
When the calibrator barcode is scanned by the barcode reader, calibration is
automatically requested for the assay.
3 Choose Start. The monitor displays the previous screen and the calibration and
control run begins.
If automatic printout has been selected at Utility > System (Page 2/3) > Documentation Setup, the
Calibration Result report will be printed automatically when calibration is complete.
4 Remove calibrators and controls from the sample disk or rack when sampling is
complete. Close the lids of the calibrator and control vials and return them to the
refrigerator.
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S/N 0703-37
********************************************************************************************
Calibration Result
Operator-ID:Admin
2006-05-23, 12:35
------------------
-----------------
: TSH 0
Unit
: ulU/ml
: 139709
: 32700
: 2006/07
L Calibration
L calibration date
: 2005/12/14
: 32700
: 168530
: 2006/04
Recalibration recommended at
: 2006/01/11
RP Calibration
RP Calibration date
: 2006/12/14
: 32700
: 168530
: 2006/04
Recalibration recommended at
: 2005/12/21
Monotony of curve
Calibration factor
1.00
Minimum signal
----------
-----
Deviation of duplicates
-----
System errors
-----
Calibrators
1. signal
2. signal
--------------
Target value
842.7
799.0
0.100 ulU/ml
26488
25430
1.61 ulU/ml
Figure B-25
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6 Daily operation
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Figure B-26
Calibration status.
None
Red
Green (in
Calibration is selected. Calibration can be performed manually or by the system.
Select field)
Table B-2
In the case of a rejected or failed calibration without a previous valid calibration, the instrument
stops test-specific sample pipetting (depending on the system settings), and it will be necessary to
perform a new calibration.
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2 Select the calibration to be checked in the Status list and choose the Calibration
Result button to display the Calibration Result window. This window is different
for quantitative and for qualitative assays.
Figure B-27
Figure B-28
3 Choose the Calibration Trace button to check the calibration trace. The
Calibration Trace window is displayed.
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6 Daily operation
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Figure B-29
Accumulate QC results
The results of controls measured are saved in the database and appear on the Data
Review screen as well as the QC > Individual screen. To ensure good quality statistical
data, it is important to accumulate these results regularly for the long-term quality
control data.
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D
C
A
C
in the grommet)
Figure B-30
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6 Daily operation
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Figure B-31
To improve the alignment of 13 mm tubes on the rack, Roche recommend that the
Roche Cup-Adapters (part name: CUP-ADAPTER FOR STANDARD RACK) is used.
Cup-Adapters are placed as an insert to the Standard Rack, as shown in the following
figure.
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A
B
Cup-Adapters
Figure B-32
The Roche Cup-Adapters should be used only for the sample tubes specified for use
with the cobas e 411 analyzer. Tubes with an outer diameter greater than 13mm should
not be used in combination with Cup-Adapters, because the barcode label might be
damaged.
e For details of the various sample tubes specified for use with the cobas e 411 analyzer,
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For essential safety information, see Loading and unloading the sample disk on page A-14.
Figure B-33
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6 Daily operation
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a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).
Figure B-34
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
Check the following:
o
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
If the host does not answer within 15 seconds, the position is skipped and the disk advances to the
next position.
If you are using the batch mode for the analyzer-host-communication, make sure that all requests
are loaded from the host to the analyzer.
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For essential safety information, see Loading and unloading the sample disk on page A-14.
Figure B-35
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a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).
Figure B-36
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
Patient programming for non-interfaced, barcoded samples
In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to Yes.
a To load patient samples
1 Place the barcoded samples on the sample disk. Make sure the barcodes are facing
out so the barcode reader scans them properly.
For essential safety information, see Loading and unloading the sample disk on page A-14.
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6 Daily operation
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Figure B-37
a To start processing
The first step is to do a sample scan.
1 Choose Sample Tracking.
2 Choose Sample Scan. Wait for the system to go to Standby.
3 Choose Workplace > Test Selection
4 Choose Start (global button).
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Figure B-38
5 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
Check the following:
Disk number displayed in the window is correct.
Host Communication setting is On (if a host connection is being used)
6 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
Patient programming for non-interfaced, non-barcoded samples
In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.
Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.
When not using sample barcodes, you can either use a numeric sample ID or
alternatively type in characters using the software keyboard.
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6 Daily operation
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Figure B-39
2 Select the Routine option from the Sample area on the top left of the screen.
3 Type the disk number in the Disk No. text box.
4 Type the position number for the sample in the Pos. text box.
5 Type the sample number in the Sample ID text box if necessary.
6 Select the Pre-dilution button if the sample has already been diluted
7 Select the Normal or Reduced Sample Cup button.
8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
9 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
10 Choose Save to save the test selection.
11 Place a stop barcode in the next open position on the disk.
If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.
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a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).
Figure B-40
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
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Figure B-41
Roche Diagnostics
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6 Daily operation
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a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).
Figure B-42
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each barcode is
scanned, the analyzer queries the host and receives test requests for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.
Patient programming for interfaced, non-barcoded samples
In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.
a To perform sample programming for real-time queries
1 Perform sample programming at the host. Make sure to program the rack ID and
position number at the host.
2 Print a work list at the host.
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Figure B-43
a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).
Figure B-44
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
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6 Daily operation
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3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each rack position
is encountered, the host is queried to download the sample ID and test selections
to the analyzer.
Patient programming for non-interfaced, barcoded samples
In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to Yes.
Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.
You can only use a numeric sample ID when not using a host. This is because you
cannot perform a sample scan (as on the disk system); you must type all sample ID
numbers manually.
a To perform sample programming
1 Choose Workplace > Test Selection.
Figure B-45
2 Select the Routine option from the Sample area on the top left of the screen.
3 Choose the Sample ID field to open the software keyboard. Type in the sample ID
of the sample in the Sample ID text box.
4 Select the Pre-dilution On button if the sample has already been diluted manually.
5 Select the Normal or Reduced button for Sample Cup.
6 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
7 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
8 Choose Save to save the test selection.
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It is not necessary to program a rack ID and position when the sample is barcoded.
Figure B-46
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each barcode is
scanned, the analyzer queries the host and receives test requests for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.
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Figure B-47
2 Select the Routine option from the Sample area on the top left of the screen.
3 Type the rack number in the Rack No. text box.
4 Type the position number for the sample in the Pos. text box.
5 Type the sample number in the Sample ID text box, if necessary.
6 Select the Pre-dilution check box if the sample has already been diluted.
7 Select the Normal or Reduced button for Sample Cup.
8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
9 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
10 Choose Save to save the test selection.
a To load patient samples
1 Load the racks on a tray.
2 Place the tray on the A-Line (supply). At the same time, verify there is a tray on the
C-Line (output buffer). If necessary, place a tray on the C-Line.
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Figure B-48
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).
Figure B-49
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
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e If you wish to track samples, add patients during routine operation, or process a STAT
(Short Turn Around Time) patient sample, proceed to one of the following sections:
Sample tracking: rack system on page B-77
Measurement of additional routine samples on page B-60
STAT test selections: rack system on page B-67.
For essential safety information, see Continuous sample loading on sample disks on page A-13.
For essential safety information, see Loading and unloading the sample disk on page A-14.
If you forget to place the Stop barcode on the disk, the disk turns continuously. If calibrators or
controls are present, they will be pipetted again.
4
5
6
7
STOP
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2 When the sample in position 4 is complete, add seven more samples to the disk.
Move the Stop barcode to position 15.
1 2
3
X X
X
4
5
6
7
8
9
10
11
STOP
12
14
15
13
All 14 samples have been pipetted. The analyzer goes into Sampling Stop when it
reaches the Stop barcode in position 15.
1 2
3
X X
X
4
5
X
6
X
X 7
X 8
X 9
X
10
X
11
X
STOP
15
X
14
12
13
3 Add samples starting at position 15 (the previous position of the Stop barcode).
After choosing Start the system continues sampling past position 30 until it sees
the Stop barcode again (here in position 6).
28
29
30
2 3
4
5
27
26
25
STOP
24
23
22
21
20
19
18 17
16 15
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6 Daily operation
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For essential safety information, see Loading and unloading the sample disk on page A-14.
If you forget to place the Stop barcode on the disk, the disk stops at position 30.
Figure B-50
Loading/unloading of racks
You can add single racks to the A-Line only when the tray indication light is green. When the light
is out, do not load racks onto the analyzer.
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6 Daily operation
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Tray
Part 3
Tray
Part 2
Tray
Part 1
Output
buffer
C-Line
A green light
indicates that you
can remove or
replace a tray
5 racks
A-Line
5 racks
5 racks
Input
buffer
STAT
Tray
indication
light
5 racks
B-Line
Tray
indication
light
Figure B-51
You can add racks during operation. When the rack system is in sampling stop mode,
choose Start to continue sampling.
Test selections must be made at the host system before a sample query from the analyzer.
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Figure B-52
2 Select the Stat option from the Sample area on the top left of the screen.
o
In non-barcode mode the cursor moves to the Pos. text box. Go to step 3.
In barcode mode the cursor moves to the Sample ID text box. Go to step 4.
3 Type in the position number of the sample in the Pos. text box.
For essential safety information, see Loading samples and reagents on page A-14.
For essential safety information, see Manual assignment of sample containers on page A-9.
7 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box and press Tab.
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8 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
9 Choose Save to save the test selection.
a To start processing STAT samples
1 Choose Stat Rack (global button).
Figure B-53
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.
STAT patient programming for non-interfaced, barcoded or non-barcoded samples
In the STAT mode, when the Test Selection screen is opened, an available disk
position is suggested by the software. You can override the position suggested by the
system.
a To program barcoded STAT samples
1 Load the sample at a vacant position behind the Stop barcode.
2 Choose S.Stop, and perform Sample Scan.
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Figure B-54
2 Select the Stat option from the Sample area on the top left of the screen.
3 Type in the position number of the sample in the Pos. text box.
For essential safety information, see Loading samples and reagents on page A-14.
For essential safety information, see Manual assignment of sample containers on page A-9.
7 Select the required dilution, if any, for the sample from the Sample Volume/
Dilution list box.
8 Select the test, combination of tests or test profiles for the sample from the test key
matrix. Selected tests and profile keys appear white.
9 Choose Save to save the test selection.
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Figure B-55
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.
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6 Daily operation
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Refer to the label on the STAT rack position to ensure correct orientation of the rack.
Figure B-56
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Figure B-57
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples. As each barcode is
scanned, the analyzer queries the host and receives test selections for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.
If multiple STAT racks are necessary, you must choose Stat each time a STAT rack is loaded in the
STAT rack position.
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Figure B-58
3 Select the Stat option from the Sample area on the top left of the screen.
o
In non-barcode mode the cursor moves to the Rack No. text box. Go to step 4.
In barcode mode the cursor moves to the Sample ID text box. Go to step 6.
4 Type in the rack ID of the sample in the Rack No. text box.
5 Type in the position number of the sample in the Pos. text box.
For essential safety information, see Loading samples and reagents on page A-14.
For essential safety information, see Manual assignment of sample containers on page A-9.
9 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
10 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
11 Choose Save to save the test selection.
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For essential safety information, see Loading STAT racks on page A-15.
Figure B-59
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Figure B-60
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.
If multiple STAT racks are necessary, you must choose Stat each time a STAT rack is loaded in the
STAT rack position.
Refer to the label on the STAT rack position to ensure correct orientation of the rack.
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Figure B-61
Figure B-62
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples. As each STAT rack
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position is encountered, the host is queried to download the sample ID and test
selections to the analyzer.
If multiple STAT racks are necessary, you must choose the Stat key each time a STAT rack is loaded
in the STAT rack position.
Dilution
Sample results that exceed the measuring range of the assay must be diluted and
measured again. Dilutions can be requested from the Workplace > Test Selection
screen and are performed automatically by the analyzer.
Figure B-63
The Sample Volume/Dilution menu is activated only when both the following apply:
o
The assays are encoded in the reagent barcode as being suitable for dilution.
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After changes have been made on the Test Selection screen, the Save button turns
yellow.
4 Choose Save to save the entries. A predilution flag is added to the sample ID.
After measurement, the target sample is flagged Prediluted on the Test Review
screen and on the result report.
The results for prediluted samples are not calculated using the dilution factor. The operator must
calculate the final results for manually prediluted samples.
5 Choose Save. The test key button appears with the dilution rate you have just
specified.
When measurement starts, the sample is automatically diluted by the analyzer. When
calculating the final sample concentration, the software calculates the result based on
the selected dilution factor.
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Figure B-64
Stat
Control
Calibrator
Empty (E)
Processing (P)
Incomplete (I)
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6 Daily operation
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Occupied (O)
Completed (C)
Stop BC (S)
Sample positions that contain a STAT sample appear red throughout the operation, even though
their actual status changes.
3 To obtain more detailed information on the result of a specific sample, select the
sample from the Sample disk information area on the right side, and then choose
the Show Result button. The Test Review window is displayed.
Figure B-65
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Figure B-66
Thirty positions (six rows) are listed on the screen, each row representing a rack. To
the right of each row is the rack ID number. The upper right corner of each button
corresponds to a position on the rack. Each position also lists a status.
The status conditions are as follows:
Routine
Stat
Control
Calibrator
Empty (E)
Processing (P)
Incomplete (I)
Occupied (O)
Completed (C)
Sample positions that contain a STAT sample appear red throughout operation, even though their
actual status changes.
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6 Daily operation
Routine operation
Figure B-67
A
B
C
Tray 3
Tray 1
Figure B-68
Tray 2
When the AssayCup and AssayTip compartments are fully loaded, the analyzer begins
by using AssayCups and AssayTips from tray 1.
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6 Daily operation
Routine operation
When tray 1 is empty, the analyzer starts using tray 2, followed by tray 3.
When tray 3 is empty, the analyzer returns to tray position 1 to check if a new tray has
been loaded.
The analyzer indicates the current gripper position for AssayCups (Vessel) and
AssayTips (Tip) on the System Overview screen. In Figure B-69, the Inventory area
shows the gripper position markers at the tray 1 position for both AssayCups and
AssayTips. Trays 2 and 3 for both are full.
Figure B-69
When the AssayCup and AssayTip compartments are only partly loaded, the analyzer
starts using AssayCups and AssayTips from the positions last in use during the
previous run. The AssayCup position may be different from the AssayTip position in
this case.
Table B-3 shows how you can use to Vessel and Tip symbols in the System Overview
screen to determine when you can safely load additional consumables at the tray
positions.
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6 Daily operation
Results
Loading options
(Vessel/Tip)
Table B-3
Results
You can evaluate control and patient results on printed reports or on the Workplace >
Data Review screen. All samples can be viewed, deleted, printed, or uploaded from
this screen.
As results are generated on the instrument, they are saved in the database located on
the control unit. The database stores up to 2000 results, depending upon the number
of orders in the system. Once the figure of 2000 documents is reached, the system
automatically deletes the oldest documented result. You can manually delete any
results, documented or undocumented, from the database to free additional space.
As soon as results are printed, uploaded or printed/uploaded, they are considered to
be documented (the documentation mode is defined in the Utility > System >
Documentation Setup window).
After documentation, an H appears at the top of the row. Partial sample results can
be viewed from this screen as soon they are made available by the system.
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6 Daily operation
Results
e For more information, see:
Figure B-70
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6 Daily operation
Results
Figure B-71
2 Choose Search to display the Sample Search window, used to search for a sample
in the database.
Figure B-72
3 Select either the Sequence Number option to search for a sample by sequence
number, or the Sample ID option to search by sample number.
4 Type the sequence or sample number, depending on the option selected in the
previous step.
5 Choose Down to search the sample list of the Data Review screen downward from
the currently selected sample, or Up to search upward from the currently selected
sample, until you find the required sample.
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6 Daily operation
Results
6 Choose Cancel to close the Sample Search window and return to the Data Review
Screen. The chosen sample is highlighted.
Figure B-73
Filter window
2 Enter filter criteria as required, and choose OK to save the selected filter criteria,
close the Filter window, and return to the Data Review Screen.
3 Select On in the Filter area of the Data Review screen to activate the filter. The
results are filtered according to the filter criteria you selected.
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6 Daily operation
Results
Upload
Print/Upload
Send reports to the printer and also upload results to the host.
Control Sample
STAT Sample
Routine Sample
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6 Daily operation
Results
Figure B-74
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6 Daily operation
Post-operation data management
Daily maintenance
Before the end of routine operation, it is important to ensure that all required
maintenance is performed. In addition to the routine daily maintenance, this could
also include other scheduled maintenance, for example, weekly and monthly
maintenance.
Perform the following tasks each day:
o
Finalization maintenance.
e For information about daily maintenance items to be performed, refer to your laboratory
maintenance schedule, Maintenance schedule on page C-8 and the Maintenance chapter.
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6 Daily operation
In normal operation, the monitor will remain powered for prolonged periods. To preserve the image
quality of the monitor, Roche recommends that you activate the screen saver.
Use the Utility > System screen to activate the screen saver.
Figure B-75
Sleep window
In the Sleep window, do not choose Shutdown unless you wish to shut down all of the analyzer
functions and components.
If choose Shutdown by mistake, turn off the main circuit breaker once, wait for at least ten seconds,
and then turn it on again to revive the analyzer.
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6 Daily operation
Switch off the analyzer
1 Open the sipper shield by applying pressure to the white metal area at the top, as
shown in the following figure, until the latch is released.
Figure B-76
Figure B-77
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6 Daily operation
3 Close the sipper shield by applying pressure to the white metal area at the top until
you hear the click of the latch engaging.
page C-44.
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In this chapter
Chapter
Overview ........................................................................................................................ 93
How to apply barcode labels to tubes and vials ........................................................... 94
How to upload results manually ................................................................................... 96
How to select two or more samples in Data Review .................................................... 98
How to archive sample data .......................................................................................... 99
How to rerun a sample ................................................................................................ 100
How to reset the system .............................................................................................. 101
How to delete a single open request ........................................................................... 103
How to assign calibrator and control positions ......................................................... 104
How to install and define Roche controls .................................................................. 106
How to install and define non-Roche controls .......................................................... 107
How to edit control values .......................................................................................... 109
How to request standby bottle QC ............................................................................. 110
How to cancel a print job ............................................................................................ 111
How to print a daily Alarm Trace report ................................................................... 112
How to print a System Communication Trace report ............................................... 113
How to change documentation settings ..................................................................... 114
How to program calculated tests ................................................................................ 115
How to change test settings ......................................................................................... 116
How to change calibration settings ............................................................................ 118
How to change the sample disk mode ........................................................................ 119
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Overview
The sections in this chapter contain detailed descriptions explaining how to
accomplish specific non-routine tasks.
e For details of the differences for disk and rack systems, see Disk and rack systems on
page B-5.
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Figure B-78
2 For sample tubes, position your barcode labels according to restriction shown in
Figure B-79. For calibrator and control vials, position your barcode labels
according to the restriction shown in Figure B-80.
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Upper margin: 12 mm minimum (for both 100 mm and 75mm sample tubes)
Figure B-79
Figure B-80
3 Press and smooth the labels to ensure that all the label edges adhere to the tubes or
vials.
Place all sample tubes upright and settled in their positions, with the barcode labels fully visible to
the barcode reader.
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Figure B-81
2 Select an individual sample to upload from the open requests (status O).
3 Select the result to upload from the Data Review list on the right of the screen.
e See How to select two or more samples in Data Review on page B-98
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The Send to Host window closes, and the system returns to the Workplace Data
Review window. The sample status changes to H (documented/sent to host) if all
results are sent to the host.
If you wish to validate the result before uploading, switch off Automatic Upload.
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Choose QC View at Step 2 if you wish to display only the control results.
3 Select a sample from the list on the left of the screen. The selected sample is
highlighted in blue.
4 Choose Select. The Select button turns white, indicating that sample selection is
activated.
5 Select the next sample from the list. The selected sample is highlighted in blue (in
addition to the previous selection).
6 Choose Select.
7 Repeat steps 5 and 6 until all the samples required are selected.
8 Choose Print (global button). The Print window opens.
9 Choose Print in the Print window to confirm the print. The Print window closes.
To clear a complete selection, select any sample previously selected. The highlight will
disappear from all the samples.
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3 Select samples for which data is to be backed up, from the list on the left of the
screen.
4 Choose Backup Data. The Backup Data window is displayed.
Figure B-82
If choosing External, ensure that the target device is connected and able to receive the data.
6 Type a folder name for the current backup in the Folder name box, and choose
OK.
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Figure B-83
6 Select the sample dilution from the list box on the right of the screen.
7 Choose Save. The Save button changes from yellow to blue, and the test buttons
change back from white to blue.
8 Choose Data Review (see Figure B-81). Note that the sample is now listed twice on
the left of the screen - once for the original tests and once for the rerun selection.
9 Place the sample on the instrument and choose Start (global button).
10 Choose Start (large button) in the Start Conditions window.
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Any movement of the pipetter shield away from the fully closed position during
operation.
Resetting the system returns mechanical parts to their home or standby positions. It
does not reset any of the line mechanisms on a rack system.
a To reset the system
1 Choose Utility > Maintenance.
Figure B-84
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Figure B-85
4 Choose Start. The system reset begins and the System Reset window closes.
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Figure B-86
4 Confirm the deletion in the Delete Record window. The window closes
automatically and the selected sample is no longer listed in the Data Review
window.
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Figure B-87
4 Select a calibrator from the list on the left of the screen, and a position for the
calibrator from the list on the right.
5 Choose Assign to assign the selected calibrator to the position selected. The
calibrator and the corresponding lot number appear on the right of the screen,
and the Assign button becomes inactive. The OK button turns yellow and remains
yellow until you save the changes in step 7. You can assign a calibrator to one
position only.
6 Repeat steps 4 to 5 to assign further calibrators.
7 Choose OK to save the changes when each of the desired calibrators has an
assigned position. The Position Assignment window closes.
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Figure B-88
5 Choose Assign to assign the selected control to the position selected. The control
and the corresponding lot number appear on the right of the screen, and the
Assign button becomes inactive. The OK button turns yellow and remains yellow
until you save the changes in step 7. You can assign a control to one position only.
6 Repeat steps 4 to 5 to assign further controls.
7 Choose OK to save the changes when each of the desired controls has an assigned
position. The Position Assignment window closes.
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Figure B-89
During the reading process the system status changes from Standby to BC card
scan. When scanning is complete, the list on the left of the QC > Install >
Individual screen shows the control and its lot number, and the system status
returns to Standby. The right of the screen displays the tests that are on board and
encoded in the control barcode, together with the reagent lot number, T.Mean,
and T.SD. The Active Test button color is green.
5 Select a test you wish to activate, and choose Active Test. The selected test name
displays a green highlight, the caption of Active Test button changes to Inactive
Test, and the button color changes to blue.
6 Repeat step 5 for every test you wish to activate.
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Figure B-90
4 Enter the control information into the Add Control fields using the software
keyboard. The Material Code for non-Roche controls must be in the range 64-78.
5 Choose OK to confirm the entries. The Add Control window closes.
6 Select the non-Roche control on the left of the screen.
7 Choose Edit. The Edit Control window opens.
8 Choose Test Assign. The Test Assign window opens.
Figure B-91
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Figure B-92
Figure B-93
4 Select the test to be edited, and enter the values given in the package into the
Individual T.Mean and T.SD fields.
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5 Choose Update to transfer the entries to the list of tests. The Calculate button is
only active for tests that are set for QC violation.
6 Choose OK to confirm the changes to the control values. The Edit Control
window closes.
Figure B-94
4 Choose a required test from the list. The chosen line is highlighted.
5 Choose Select. A tick and a change of background in the Selection column identify
the selected test.
6 Repeat steps 4 and 5 for any other selections required.
7 Choose OK to confirm the selection. The Stand By Bottle QC screen closes. The
chosen tests are now identified in the Selection column on the QC > Status screen.
To deselect manually selected standby bottle QC controls, navigate to the Stand By
Bottle QC screen, highlight the reagents required, choose Deselect, followed by OK to
confirm the deselection.
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Figure B-95
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Figure B-96
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Figure B-97
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Figure B-98
This programming generates two test requests. If one test fails then the calculation will fail.
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Figure B-99
4 Select a default dilution ratio from the list box. Refer to the reagent package insert
for the recommended dilution ratio.
5 Choose Save to confirm the dilution change.
6 Choose Utility > Application > Range.
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Figure B-100
7 Change the User Test No., the Unit, and the Expected Values as required.
The User Test No. defines the order of the test keys in Workplace > Test Selection.
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Figure B-101
Roche Diagnostics
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Figure B-102
2 Choose Change in the Sample Rotor Mode area. The Sample Rotor Mode window
opens.
Figure B-103
3 Select Single or Multiple to change the mode, and choose OK. A yellow
Confirmation window appears.
4 Choose Yes to change the mode. The yellow Confirmation window will close. The
OK button in the Utility > System screen changes to yellow.
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Maintenance
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
8 Maintenance
Table of contents
Maintenance
In this chapter
Chapter
Overview .......................................................................................................................... 5
Maintenance procedures ........................................................................................... 5
Performing maintenance .......................................................................................... 6
Maintenance items .................................................................................................... 6
Maintenance schedule ..................................................................................................... 8
Daily ........................................................................................................................... 8
Weekly ........................................................................................................................ 8
Every two weeks ......................................................................................................... 8
Every two months ...................................................................................................... 9
As needed ................................................................................................................... 9
Maintenance log .............................................................................................................. 9
Daily maintenance ......................................................................................................... 12
Clean the sample/reagent probe ............................................................................. 12
Clean the direct drain flow path ............................................................................. 13
Check for condensation inside compartments ...................................................... 14
Weekly maintenance ..................................................................................................... 15
Clean the sipper probe ............................................................................................ 15
Clean the incubator and aspiration station ........................................................... 17
Every two weeks maintenance ...................................................................................... 19
Clean the rinse stations ........................................................................................... 19
Liquid flow cleaning ................................................................................................ 22
Every two months maintenance ................................................................................... 24
Replace the pinch valve tubing ............................................................................... 24
As needed maintenance ................................................................................................ 30
Perform finalization maintenance .......................................................................... 30
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8 Maintenance
Table of contents
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8 Maintenance
Overview
Overview
This chapter contains an overview of maintenance on the system including the
following topics:
o
Types of maintenance
All of the software screens shown are examples only. Your screens may vary
depending on your system setup.
The maintenance procedures are listed in order of descending frequency. Each
procedure is presented in the same way, with planning information at the beginning,
followed by the procedure.
Maintenance procedures
Each maintenance task section is divided into two parts: Introduction and Procedure.
The introduction provides important information about the procedure including the
following matters:
o
Materials required
Time required
Precautions
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8 Maintenance
Overview
For essential safety information, see Operation and maintenance on page A-9.
Performing maintenance
There are two types of maintenance on the system:
o
Maintenance items
Figure C-1
Roche Diagnostics
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8 Maintenance
Overview
Figure C-2
This section lists all system-controlled maintenance items and a brief description of
their function.
System Reset
Resets mechanical parts to their home or standby positions. A system reset is often
necessary if the analyzer is in a P. Stop or Stop status due to an alarm condition. This
button does not reset any of the line mechanisms on a rack system.
The system will stop during reagent scan or after a start if the PC/CC bottles have not
been manually opened. A reset must then be done because the sipper needle path is
blocked over the bottles. Close the sipper shield, select System Reset and choose Start.
Rack Clear
(rack system only)
Sipper Pipetter Prime
Washes the sipper flow paths and the measuring cell with SysClean.
Initiates a complete system and line reset for the rack analyzer A-, B-, and C-lines, and
returns all analyzer mechanisms to their home or standby positions. An L. and A.
Reset All is often necessary if the analyzer is in a Stop or P. Stop status due to an alarm
condition.
Clears the B-line of any racks and transfers them to the C-line.
Primes sipper flow paths with system water to purge them of air, for the specified
number of cycles.
Purges the sample/reagent pipetter flow path of air for the specified number of cycles.
Conditions the measuring cell for the specified number of cycles.
Primes the system with water, and fills the measuring cell with ProCell. This allows
the analyzer to stand unused for several hours, such as when left overnight.
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8 Maintenance
Maintenance schedule
Media Write
Opens the Media Write window to select the internal or external target device for data
storage.
Purges tubing. Also used by Roche service representatives.
Maintenance schedule
It is important that you keep to the recommended schedule for all maintenance
actions. You can find detailed descriptions of the maintenance tasks later in this
chapter.
Daily
Maintenance task
Operator
System
time (min)
time (min)
C-12
C-13
C-14
Page
Table C-1
Page
Weekly
Maintenance task
Operator
System
time (min)
time (min)
C-15
C-17
Operator
System
Page
time (min)
time (min)
Table C-2
C-19
17
C-22
Table C-3
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8 Maintenance
Maintenance log
Operator
System
time (min)
time (min)
Page
15
C-24
Page
As needed
Maintenance task
Operator
System
time (min)
time (min)
0.5
C-30
10
C-31
C-33
C-35
C-36
15
C-39
C-42
0-10
C-44
Table C-5
Maintenance log
Use the Maintenance log to record the dates when the maintenance tasks were
performed and the initials of the person who performed them.
For convenience, the cobas e 411 analyzer maintenance log is printed on two sheets.
You can make photocopies of both parts of the maintenance schedule sheet provided
on the following pages for your own records.
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8 Maintenance
Maintenance log
Clean:
10 11 12 13 14 15 16
10 11 12 13 14 15 16
10 11 12 13 14 15 16
10 11 12 13 14 15 16
Sample/Reagent probe
Direct drain flow path (if fitted)
Check:
Weekly
Clean:
Sipper probe
Incubator and aspiration stations
Operator
Clean:
Rinse stations
Replace:
As needed
10 11 12 13 14 15 16
For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operators Manual
Version 1.0.
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8 Maintenance
Maintenance log
Clean:
17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Sample/Reagent probe
Direct drain flow path (if fitted)
Check:
Weekly
Clean:
17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Sipper probe
Incubator and aspiration stations
Operator
Clean:
17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Rinse stations
Replace:
17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
As needed
17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operators Manual
Version 1.0.
2006 Roche Diagnostics
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8 Maintenance
Daily maintenance
Daily maintenance
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
Recommended frequency:
Daily
Operator time:
System time:
None
Precautions:
Table C-6
Materials
Planning considerations
Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Table C-7
Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Avoid damage to the probe on page A-13.
2 Move the sample/reagent probe to an area where you can readily access it.
3 Wipe the outer surfaces of the sample/reagent probe and its tip with a gauze pad
soaked in distilled or deionized water.
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8 Maintenance
Daily maintenance
Sample/reagent probe
Figure C-3
4 Inspect the probe. If any dirt is visible, wipe the outer surfaces with a gauze pad
soaked in 70% isopropyl alcohol, and a second wipe with a gauze pad soaked in
distilled or deionized water.
5 Switch on the analyzer.
The analyzer performs a start-up reset operation, and each mechanism returns to
its home or standby position.
Operator time:
System time:
None
Precautions:
Table C-8
Planning considerations
Item
Required materials
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8 Maintenance
Daily maintenance
Tank inlet
Figure C-4
If the tube is clogged, contact your Roche service representative. Do not try to unclog the tube
yourself.
Planning
Recommended frequency:
Daily
Operator time:
System time:
None
Precautions:
Table C-10
Materials
Planning considerations
Item
Gauze pads
Table C-11
Required materials
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8 Maintenance
Weekly maintenance
Weekly maintenance
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
Recommended frequency:
Weekly
Operator time:
System time:
None
Precautions:
Table C-12
Planning considerations
Materials
Item
Gauze pads
Cotton swabs
70% isopropyl alcohol
Table C-13
Required materials
3 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
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8 Maintenance
Weekly maintenance
Figure C-5
Sipper shield
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Avoid damage to the probe on page A-13.
4 Move the sipper probe to an area where you can readily access it.
5 Wipe the outer surfaces of the sipper probe with a gauze pad soaked in 70%
isopropyl alcohol, followed by a wipe with a gauze pad soaked in distilled or
deionized water.
A
B
Sipper probe
Figure C-6
6 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
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8 Maintenance
Weekly maintenance
Recommended frequency:
Weekly
Operator time:
System time:
None
Precautions:
Table C-14
Materials
Planning considerations
Item
Gauze pads
Cotton swabs
Distilled or deionized water
Table C-15
Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
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8 Maintenance
Weekly maintenance
7 Wet a cotton swab with distilled or deionized water and swab each of the 32
positions on the incubator, as well as the aspiration station.
A
A
Aspiration station
Figure C-7
B
B
8 Use a dry gauze pad to dry the incubator when you have finished cleaning.
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8 Maintenance
Every two weeks maintenance
Recommended frequency:
Operator time:
System time:
None
Precautions:
Table C-16
Materials
Planning considerations
Item
Cotton swabs
Distilled or deionized water (approx 300 mL)
Syringe with attached tubing
70% isopropyl alcohol
Table C-17
Required materials
You may find it easier to use two syringes for this procedureone for aspirating liquid and the
other for refilling the rinse stations.
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Avoid damage to the probe on page A-13.
2 Move the sample/reagent probe, the microbead mixer, and the sipper probe to an
area away from the rinse stations.
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8 Maintenance
A
C
Figure C-8
Rinse station
3 Aspirate the water out of the microbead mixer rinse station using a syringe with
tubing attached.
Microbead mixer
Attached tube
Syringe
Figure C-9
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8 Maintenance
Every two weeks maintenance
4 Use a cotton swab soaked in 70% isopropyl alcohol to clean thoroughly the
microbead mixer rinse station and the sipper rinse stations.
A
B
Swab
Figure C-10
Rinse station
5 Wipe the microbead mixer rinse station and the sipper rinse station again using a
fresh cotton swab soaked in distilled or deionized water.
6 Fill the syringe with distilled or deionized water, and refill the microbead mixer
rinse station. This should take approximately 50-100 mL of water.
7 Flush the sample/reagent probe and sipper rinse stations with water (50-100 mL).
8 Aspirate the water out of the microbead mixer rinse station again, by using the
syringe.
9 Refill the microbead mixer rinse station, and flush all the rinse stations with
distilled or deionized water again.
10 Switch on the analyzer at the operation switch.
The analyzer performs a start-up reset operation, and each mechanism
automatically returns to its home or standby position.
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8 Maintenance
Recommended frequency:
Operator time:
Approximately 4 minutes.
System time:
Approximately 17 minutes.
Precautions:
Table C-18
Materials
Planning considerations
Item
SysClean
SysClean adapter
Distilled or deionized water
Table C-19
Required materials
For essential safety information, see Handling of cleaning solutions (detergents) on page A-8.
For essential safety information, see Contact with solutions on page A-6.
For essential safety information, see Avoid use of bleach on page A-6.
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8 Maintenance
Every two weeks maintenance
A B
Figure C-11
5 Remove the liquid waste container and clean it thoroughly with distilled or
deionized water. Replace the empty liquid waste container.
e For additional information on cleaning the liquid waste container, see Clean the liquid
6 Verify that ProCell and CleanCell bottles are correctly located in the other three
positions, with the lids open and adequate ProCell and CleanCell in the bottles.
7 Close the sipper shield.
8 Choose Utility > Maintenance.
9 Choose Maintenance from the Maintenance Type list.
10 Select Liquid Flow Cleaning from the Maintenance Items list.
11 Choose Select to display the Liquid Flow Cleaning window.
Figure C-12
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8 Maintenance
12 Type 1 in the Cycles text box and choose Start. Wait for the analyzer to return to
Standby.
13 Remove the liquid waste container and rinse it thoroughly with distilled or
deionized water. Return the liquid waste container to the analyzer.
e For additional information on cleaning the liquid waste container, see Clean the liquid
16 Return the ProCell bottle to its correct position in bottle set 1 in the system
reagent compartment.
17 Close the sipper shield.
Recommended frequency:
Operator time:
System time:
Approximately 15 minutes
Precautions:
Table C-20
Planning considerations
Roche Diagnostics
C-24
8 Maintenance
Every two months maintenance
Materials
Item
Required materials
It is highly recommended that you keep a spare Tube joint B on-site. There is a risk that this part
may be damaged during replacement of the Pinch valve tubing.
For essential safety information, see Residual liquid in pinch valve tubing on page A-11
For essential safety information, see Tubing and fittings on page A-17.
Roche Diagnostics
Operators Manual Version 1.0
C-25
8 Maintenance
Figure C-13
Roche Diagnostics
C-26
8 Maintenance
Every two months maintenance
Figure C-14
4 Carefully remove the tubing from the fittings on the metal plate and discard.
There may still be some liquid in the tubing. The liquid that flows through this
tubing comes from the measuring cell and is potentially biohazardous. Use gauze
pads and paper towels to prevent spillage.
Figure C-15
Roche Diagnostics
Operators Manual Version 1.0
C-27
8 Maintenance
Pinch valve
Figure C-16
Tubing
8 Carefully slide the ends of the tubing over each of the fittings in turn.
A B
Fitting
Figure C-17
Tubing
Roche Diagnostics
C-28
8 Maintenance
Every two months maintenance
A
B
C
Fitting
Valve block
Figure C-18
O-ring
Replacing a fitting
Roche Diagnostics
Operators Manual Version 1.0
C-29
8 Maintenance
As needed maintenance
As needed maintenance
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
Recommended frequency:
Operator time:
Approximately 30 seconds
System time:
Precautions:
None
Table C-22
Materials
Planning considerations
None
Roche Diagnostics
C-30
8 Maintenance
As needed maintenance
Recommended frequency:
As needed
Operator time:
Approximately 10 minutes
System time:
None
Precautions:
Table C-23
Materials
Planning considerations
Item
Gauze pads
Cleaning brush
Distilled or deionized water
Paper towels
70% isopropyl alcohol
Table C-24
Required materials
Figure C-19
C-31
8 Maintenance
As needed maintenance
5 Inspect the inside of the container and scrub away any visible dirt or
contamination using a large cleaning brush immersed in 70% isopropyl alcohol.
Rinse thoroughly with distilled or deionized water.
6 Remove the valve on the bottom of the system water container.
Figure C-20
7 Clean the valve with a wet brush, then rinse with distilled or deionized water. If
the valve appears to be dirty, use a brush immersed in 70% isopropyl alcohol to
clean the valve. Then, rinse thoroughly with distilled or deionized water.
8 Use a gauze pad to wipe and clean the aspiration inlet for the distilled or deionized
water supply.
9 Connect the valve to the container bottom and fill the container with distilled or
deionized water.
10 Add 35 mL of SysWash to the distilled or deionized water, pouring carefully to
avoid creating air bubbles. This gives a SysWash dilution of 1+100.
11 Dry the outside of the container with paper towels, attach the cap to the container,
and return the container to the analyzer.
Aspiration inlet
Figure C-21
Roche Diagnostics
C-32
8 Maintenance
As needed maintenance
As needed
Operator time:
System time:
None
Precautions:
Table C-25
Materials
Planning considerations
Item
Required materials
For essential safety information, see Avoid use of bleach on page A-6.
Roche Diagnostics
Operators Manual Version 1.0
C-33
8 Maintenance
As needed maintenance
Figure C-22
Roche Diagnostics
C-34
8 Maintenance
As needed maintenance
8 Position the drain tubing with no upwards slope or U-bend. See Analyser
Components - Direct drain system (optional).
9 Replace the container window plate.
Recommended frequency:
As needed
Operator time:
System time:
None
Precautions:
Table C-27
Materials
Planning considerations
Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Table C-28
Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Bent or damaged microbead mixer paddle on page A-6.
Roche Diagnostics
Operators Manual Version 1.0
C-35
8 Maintenance
As needed maintenance
Mixer paddle
Figure C-23
3 Wipe the outer surface of the microbead mixer paddle carefully, using a gauze pad
soaked in 70% isopropyl alcohol. Repeat with a new gauze pad soaked in distilled
water. Take care not to bend the mixer paddle during cleaning.
4 Switch on the power to the analyzer. The analyzer performs a start-up reset and
each mechanism returns to its home or standby position.
Recommended frequency:
As needed
Operator time:
System time:
None
Precautions:
Table C-29
Materials
Planning considerations
Item
Gauze pads
Cotton swabs
Distilled or deionized water
70% isopropyl alcohol
Table C-30
Required materials
Roche Diagnostics
C-36
8 Maintenance
As needed maintenance
3 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
e For the location of the sipper shield, see Figure C-5 on page C-16.
For essential safety information, see Avoid damage to motorized components on page A-13.
4 Move the sipper arm manually as far to the left as the arm will allow.
5 Remove all four ProCell and CleanCell reagent bottles from their compartments.
6 Wipe the sipper shield with a damp gauze pad and repeat with a dry gauze pad.
Figure C-24
Roche Diagnostics
Operators Manual Version 1.0
C-37
8 Maintenance
As needed maintenance
7 Wipe the inside of the compartments with damp (not wet) gauze pads. Do not
allow water to pool in the bottom of the compartments. Avoid the photosensors in
the two inside compartments, that check for the presence of ProCell/CleanCell
bottle sets. Each sensor is in a rectangular window at the back of its compartment,
just below the top edge. If you wet the sensors, dry them with a cotton swab.
B
A
C
B
removed)
C
Figure C-25
Roche Diagnostics
C-38
8 Maintenance
As needed maintenance
Recommended frequency:
As needed
Operator time:
Approximately 15 minutes
System time:
None
Precautions:
Table C-31
Materials
Planning considerations
Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Cloth or lint-free towels
Table C-32
Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
Roche Diagnostics
Operators Manual Version 1.0
C-39
8 Maintenance
As needed maintenance
B
A
Thumbscrews
Figure C-26
Alignment pin
A
B
A
Compartment
Figure C-27
Roche Diagnostics
C-40
8 Maintenance
As needed maintenance
7 Inspect the reagent rotor, and use gauze pads soaked with 70% isopropyl alcohol
to clean any visible dirt from the rotor. Wipe the cleaned rotor with gauze pads
soaked with distilled or deionized water.
8 Dry the reagent rotor with a cloth or lint-free towels.
9 Set the reagent rotor to one side while cleaning the reagent rotor compartment.
a Procedure 2: To clean the reagent rotor compartment
1 Ensure that the analyzer is switched off at the Operation switch.
2 If you find any condensation inside the compartment, wipe it off with dry gauze
pads.
3 Wipe the reagent rotor compartment and the barcode reader window with gauze
pads soaked with distilled or deionized water.
For essential safety information, see Barcode reader window on page 13.
Figure C-28
4 Inspect the reagent rotor compartment and the barcode reader window. Remove
any visible dirt or contamination using gauze pads soaked with 70% isopropyl
alcohol. Then wipe the cleaned reagent rotor compartment and barcode reader
window with gauze pads soaked with distilled or deionized water.
5 Dry the reagent rotor compartment and the barcode reader window with a cloth
or lint-free towels.
6 Return the reagent rotor to the compartment.
7 Note that the rotor is keyed; make sure that the alignment pin on the center plate
is aligned with the hole on the rotor.
8 Replace and secure the thumbscrews.
Roche Diagnostics
Operators Manual Version 1.0
C-41
8 Maintenance
As needed maintenance
Recommended frequency:
As needed
Operator time:
System time:
None
Precautions:
Table C-33
Materials
Planning considerations
Item
Clean-Liner
Table C-34
Required materials
For essential safety information, see Changing the Clean-Liner on page A-6.
Roche Diagnostics
C-42
8 Maintenance
As needed maintenance
C
A
Sliding lid
Waste tray
Figure C-29
4 Remove the Clean-Liner from the tray and dispose of it according to the waste
handling and disposal procedures that apply in your laboratory.
5 Place a fresh Clean-Liner into the tray.
6 Verify that the sliding door is open and that the opening is located at the back of
the tray.
7 Insert the tray into the analyzer and close the door.
On the System Overview screen, the solid waste counter automatically resets to 0
(zero) when the solid waste tray is removed.
8 Dispose of the Clean-Liner appropriately, as it contains potentially biohazardous
material.
If you remove the solid waste tray for any reason you should also discard the solid waste or replace
the Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during
the course of operation. When the analyzer senses that the solid waste tray was removed, the
counter resets to 0 (zero).
Roche Diagnostics
Operators Manual Version 1.0
C-43
8 Maintenance
As needed maintenance
Shutdown procedure
Startup process
One week
No special action
One to four weeks After operation, perform a sipper prime (5 times) Perform measuring
cell preparation (30
to fill the measuring cell with system water. The
times).
measuring cell will remain in the instrument.
Four weeks and
longer
Table C-35
Roche Diagnostics
C-44
Troubleshooting
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
10
9 Troubleshooting
Table of contents
Troubleshooting
In this chapter
Chapter
Introduction .................................................................................................................... 5
Alarms .............................................................................................................................. 5
Problem categories .......................................................................................................... 5
Sample/reagent problems ......................................................................................... 6
Instrument/hardware problems ............................................................................... 6
Computer/software problems .................................................................................. 6
Facility problems ...................................................................................................... 7
Operator's primary responsibility ............................................................................ 7
Contacting Technical Support ....................................................................................... 8
General information ............................................................................................ 8
Immunoassay problems ...................................................................................... 8
Software problems ............................................................................................... 8
Instrument problems .......................................................................................... 9
Basic troubleshooting flow chart .................................................................................. 10
Immunoassay troubleshooting ..................................................................................... 11
Reagents, calibrators, and controls ......................................................................... 11
When handling reagents ................................................................................... 11
When reconstituting/handling calibrators ....................................................... 12
When reconstituting/handling controls ........................................................... 12
For problems with a single sample ................................................................... 13
For problems with a single assay ...................................................................... 13
When handling system water ............................................................................ 14
When using a diluent ........................................................................................ 14
Instrument troubleshooting ......................................................................................... 14
Troubleshooting at power up .................................................................................. 14
General mechanical problem isolation .................................................................. 14
The instrument does not power up ........................................................................ 15
Cannot access another software screen .................................................................. 15
The touchscreen does not switch on ...................................................................... 16
Roche Diagnostics
Operators Manual Version 1.0
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9 Troubleshooting
Table of contents
Roche Diagnostics
Operators Manual Version 1.0
D-4
9 Troubleshooting
Introduction
Introduction
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 information in this chapter will help you to recognize the causes of various
operational problems, find information to resolve operational problems, and
minimize the potential for operator-induced problems.
e If you are unable to resolve the problem, and you need support, see Contacting Technical
Support on page D-8 for a list of information that Roche might request if you call for
assistance.
Alarms
If any abnormality occurs while the system is switched on, the system notifies the
operator of the potential problem by issuing an alarm.
There are two types of alarm:
o
Instrument alarms
These are displayed alarms that indicate abnormal instrument conditions, such as
reagent rotor temperature, and mechanical malfunctions.
Data alarms
These are printed or displayed alarms or flags that indicate unusual reaction
conditions, such as insufficient sample or reagent, or measures values outside the
limits.
e For further information, see Data alarms on page D-31.
Problem categories
The problems that may be encountered can be separated into the following categories:
o
Sample/reagent problems
Instrument/hardware problems
Computer/software problems
Facility problems
Roche Diagnostics
Operators Manual Version 1.0
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9 Troubleshooting
Problem categories
Sample/reagent problems
o
Sample cups
Sample tubes
e See:
Reagent packs not loaded correctly with the white bottle furthest from the center
of the reagent rotor
Diluent bottles not loaded with the correct barcode label facing outwards
Proper reconstitution
Aliquoting/labeling
Refrigerating
Freezing
Thawing
Operator error
Instrument/hardware problems
o
Electrical/electronic
Mechanical:
AssayCup/AssayTip jammed
Operator error:
O
Computer/software problems
o
Disk system:
O
Roche Diagnostics
D-6
9 Troubleshooting
Problem categories
Orders/result database capacity exceeded (up to 2000 results can be stored, for
routine samples, STAT (Short Turn Around Time) samples, and controls)
Alarms
Operator error
Temperature
Humidity
Power supply
Water supply
Drain
Facility problems
Maintenance
For essential safety information, see Electrical safety precautions on page A-7.
When troubleshooting, review the alarms and isolate the problem to the area denoted
by the alarms. In many cases, you may be able to find the problem, correct it, and
resume test processing. The remainder of this section provides you with instructions
and guidelines to assist you in isolating problems.
If there is a problem with barcode reading, first check the position of the barcode label.
Roche Diagnostics
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D-7
9 Troubleshooting
Description of the problem, including relevant alarm(s) and alarm code numbers
When the problem first occurred (for example, after reagent pack lot change)
Whether the problem was observed with just one system or with all systems
Immunoassay problems
The following general information is required for immunoassay problems:
o
Whether the problem was observed with just one assay or with all assays
Whether the problem was observed with just one sample type or with all sample
types
Catalog number, lot numbers, and expiration dates of calibrators and controls
Software problems
The following general information is required for software problems:
o
Roche Diagnostics
D-8
9 Troubleshooting
Contacting Technical Support
Instrument problems
The following general information is required for instrument problems:
o
Roche Diagnostics
Operators Manual Version 1.0
D-9
9 Troubleshooting
Problem detected
Was an
instrument alarm
generated?
Yes
No
Yes
Yes
No
Was a
data alarm
generated?
Continue normal
operation
Does
the alarm
recur?
Does
the alarm
recur?
Yes
No
No
Continue normal
operation
Yes
Was a
description of this
problem
found?
Yes
No
Does the
problem
recur?
No
Yes
Continue normal
operation
Call
Technical Support
Figure D-1
Roche Diagnostics
D-10
9 Troubleshooting
Immunoassay troubleshooting
Immunoassay troubleshooting
Mechanical problems are evident when the analyzer displays an alarm message. A
chemistry problem may display a data alarm, or may only become evident with an
unexpected result.
Deciding that a problem exists is the first step in the process. The following situations
may require troubleshooting:
o
When troubleshooting a problem, open the Print screen (using the Print global
button), choose Utility tab, and print an alarm list. Use this list to assist you with
troubleshooting.
To troubleshoot effectively, eliminate extraneous information and pinpoint the
problem. Use the calibration documentation, quality control results, or patient results
to decide which of the following conditions apply, and perform the associated checks
outlined in the following sections:
e See also:
For essential safety information, see Contact with solutions on page A-6.
Have the lot numbers changed? Do they match the lot numbers in the Reagent
Detail window?
Was the reagent kit stored in an upright position and at the correct temperature
(2-8C)?
Roche Diagnostics
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9 Troubleshooting
Immunoassay troubleshooting
Was the reagent allowed to reach the correct temperature on board (15 minutes
from room temperature or one hour from 4C) before starting the instrument?
Were the reagent packs within the allowed stability after opening and the
expiration dates not exceeded?
Were the partly used ProCell/CleanCell bottles replaced from the left to right side?
Were the calibrators brought to room temperature before starting the instrument?
Was the calibrator on board the analyzer for longer than the time recommended
in the package insert? (Due to possible evaporation effects, no more than five
calibration procedures should be carried out.)
Were the calibrators checked and found to be within the allowed stability after
opening?
Was crystallized material observed on the CalSet cap? (If so, discard the CalSet
vial.)
Roche Diagnostics
D-12
9 Troubleshooting
Immunoassay troubleshooting
Were the lyophilized controls carefully reconstituted with, for example, 3 mL for
PreciControl Universal and PreciControl Tumor Marker (stand closed for 30
minutes), and 2 mL for PreciControl Cardiac (stand closed for 15 minutes)?
Were the controls checked and found to be within the allowed stability after
opening, and the expiration date not exceeded?
Were drops observed hanging on the control vial cap? (You need to clean the
control caps carefully with a paper tissue.)
Was crystallized material observed on the control vial cap? (If so, discard the
control vial.)
Were the controls aliquoted and frozen? (This is recommended for controls such
as PreciControl Universal, Cardiac, and Tumor Marker.)
Sample reproducibility.
Correct preparation of the sample material (allow 30 minutes waiting time for
clotting, and centrifuge the samples before putting them on the analyzer).
Expired reagent(s).
Expired calibrators.
Roche Diagnostics
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9 Troubleshooting
Instrument troubleshooting
Was distilled water used according to the specification (conductivity <10 S/cm)?
Was the system water container carefully refilled with distilled water in order to
avoid air bubbles?
Was the correct amount (35 mL) of SysWash added to the system water?
Was the end concentration after dilution still within stated linearity?
Was the diluent checked and found to be within the allowed stability after
opening, and the expiration date not exceeded?
Instrument troubleshooting
When troubleshooting a problem, open the Print screen (using the Print global
button), choose Utility tab, and print an alarm list. Use this list to assist you with
troubleshooting.
Troubleshooting at power up
If the instrument does not power up, this could be caused by one of the conditions
listed in the following table.
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.
Cause or description
Remedy
Table D-1
Troubleshooting at power up
9 Troubleshooting
Instrument troubleshooting
recognized by the system. An audible alarm sounds, if enabled on the Alarm Sound
Setting window (Alarm > Sound), and the alarm indicator on the global Alarm
button lights, alerting you to the problem. Choose 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. Choose a specific alarm to display the alarm details and
appropriate remedy.
For certain problems affecting the instrument's performance, the system terminates
the operation mode and enters the sampling stop or stop mode. In the sampling stop
mode, the system allows completion of the samples in process unaffected by the
failure. If the problem affects all samples in process, the computer immediately
terminates the operation mode with a stop or emergency stop.
For essential safety information, see Instrument problems without alarms on page A-9.
If yes, go to step 2.
If no, go to step 3.
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 7.
If no, go to step 6.
Roche Diagnostics
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9 Troubleshooting
Instrument troubleshooting
If yes, go to step 2.
If no, go to step 3.
2 Switch the operation switch on. Does the touchscreen switch on?
o
If no, go to step 3.
If yes, go to step 2.
If no, go to step 3.
If yes, go to step 4.
If no, go to step 5.
4 Either reduce the brightness of the ambient lighting or change the direction of the
adjustable monitor face.
5 Call Technical Support.
The solid waste tray does not come out or produces unusual sounds
If you are having problems removing the solid waste tray or unusual sounds are
coming from the solid waste tray area, follow the steps below:
1 Are the tray and Clean-Liner seated correctly?
o
If yes, go to step 3.
If no, go to step 2.
If yes, go to step 4.
If no, go to step 5.
4 Remove the stray cups and tips and replace the tray and Clean-Liner.
5 Call Technical Support.
Roche Diagnostics
D-16
9 Troubleshooting
Instrument troubleshooting
If yes, go to step 3.
If no, go to step 2.
2 Make sure that the reagent rotor cover fits into the key, which is there to prevent
the cover being placed in the wrong orientation.
3 Is there an obstacle around the cover?
o
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 3.
If no, go to step 2.
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 3.
If no, go to step 2.
2 Reorient the reagent pack (the transparent cap and the barcode should face the
outside of the reagent rotor).
Roche Diagnostics
Operators Manual Version 1.0
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9 Troubleshooting
Instrument troubleshooting
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 6.
If no, go to step 7.
If yes, go to step 3.
If no, go to step 2.
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 6.
If no, go to step 7.
If yes, go to step 3.
If no, go to step 2.
2 Remove the bottle and check the position before placing the reagent into its
correct position. ProCell must only be placed in positions 1 and 3, and CleanCell
in positions 2 and 4.
Roche Diagnostics
D-18
9 Troubleshooting
Instrument troubleshooting
The analyzer can operate with just one bottle set of ProCell and CleanCell reagent, but they must be
placed either in positions 1 (ProCell) and 2 (CleanCell), or in positions 3 (ProCell) and 4
(CleanCell).
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 6.
If no, go to step 7.
If yes, go to step 3.
If no, go to step 2.
2 Reseat the container and gently push down until you feel a snap indicating that
the bottle is connected.
3 Is there an obstacle around the system water container?
o
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 6.
If no, go to step 7.
Roche Diagnostics
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9 Troubleshooting
Instrument troubleshooting
If yes, go to step 3.
If no, go to step 2.
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 6.
If no, go to step 7.
If yes, go to step 2.
If no, go to step 3.
If yes, go to step 3.
If no, go to step 2.
Roche Diagnostics
D-20
9 Troubleshooting
Instrument troubleshooting
If yes, go to step 2.
If no, go to step 3.
If yes, go to step 4.
If no, go to step 5.
If yes, go to step 3.
If no, go to step 2.
If yes, go to step 5.
If no, go to step 4.
Roche Diagnostics
Operators Manual Version 1.0
D-21
9 Troubleshooting
Instrument troubleshooting
Actions/Prevention
Is there a
removable storage device
connected to the
USB port?
Yes
Yes
No
Does
the alarm
recur?
No
Does
the alarm
recur?
No
Continue normal operation
Yes
No
Yes
Call
Technical Support
Figure D-2
Roche Diagnostics
D-22
9 Troubleshooting
Instrument troubleshooting
Bubbles in syringes
If you see bubbles in either the S/R syringe or sipper syringe, follow the steps below:
1 Perform S/R pipetter prime (item 7 on the Maintenance Items list) or sipper
pipetter prime (item 6 on the Maintenance Items list), or both primes if bubbles
are seen in both syringes, from Utility > Maintenance. Choose Parameter and type
10 in the Prime Cycles text box.
2 If there are still bubbles in the syringe, repeat this process for the appropriate
syringe.
3 If bubbles remain in the syringe after the second pipetter prime, call Technical
Support.
Roche Diagnostics
Operators Manual Version 1.0
D-23
9 Troubleshooting
Chemistry troubleshooting
Chemistry troubleshooting
False measurements
Values out of measuring range
Problem
Possible causes
Actions/Prevention
Values out of measuring range (values below the lower detection limit or values above
the measuring range).
o
Foam on sample.
Foam on controls.
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
Drift
Problem
Possible causes
Actions/Prevention
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Roche Diagnostics
D-24
9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention
Foam on sample.
Foam on controls.
Have you handled the reagents, samples and controls according to package
inserts?
Assay calibration
Calibration cannot be performed
Problem
Possible causes
Actions/Prevention
Calibrator vial barcode or calibrator lot-specific barcode card not read, or wrong
calibrator barcode card is used.
The calibration data link is not available for the current reagent pack and CalSet
combination.
Vials Cal1 and Cal2 not on same rack, or empty space between calibrator vials.
Check the barcodes of calibrator vial, calibrator barcode card, and reagent pack. Is
the barcode damaged, or not in the correct position?
Roche Diagnostics
Operators Manual Version 1.0
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9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
The calibration is not released because the monotony has not been fulfilled.
Possible causes
Calibrator not transferred to the correct barcoded calibrator vials (for example,
content of bottle Cal1 transferred to vials Cal1 and Cal2).
Actions/Prevention
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Missing values
Problem
Possible causes
Actions/Prevention
Foam on calibrator.
Empty calibrator.
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Possible causes
The calibration is not released because of values below the minimum signal (valid for
quantitative and qualitative assays), or the signal difference between vials Cal1 and
Cal2 or the maximum signal is out of limits (valid for qualitative assays only).
o
Roche Diagnostics
D-26
9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention
Foam on calibrator.
Have you handled the reagents, calibrators, and controls according to the package
inserts?
The calibration is not released because the calibration factor is out of limits.
This problem is only valid for quantitative assays, and applies to reagent pack
calibration only.
Possible causes
Actions/Prevention
Foam on calibrator.
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Roche Diagnostics
Operators Manual Version 1.0
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9 Troubleshooting
Chemistry troubleshooting
Recovery of controls
Problem
Possible causes
Actions/Prevention
Foam on controls.
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Perform a new reagent pack calibration (new reagent pack and CalSet).
Actions/Prevention
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
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9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention
Have you handled the reagents, calibrators, and controls according to the package
inserts?
Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
Actions/Prevention
There is a deviation of control and samples when measured with different systems.
o
Have you handled the reagents, system reagents, calibrators, and controls
according to the package inserts?
Method comparison
Problem
Possible causes
The number of samples is too small, or all results are within a very limited range
compared to the measuring range of the assay.
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Operators Manual Version 1.0
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9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention
Have you handled the reagents, calibrators, and samples according to the package
inserts?
Possible causes
Actions/Prevention
Take care to position the Elecsys Universal Diluent or Elecsys Diluent MultiAssay
Reagent Pack carefully, so that the cobas e 411 (Elecsys) barcode is read, and not the
one for the MODULAR ANALYTICS.
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10 Data alarms
Table of contents
Data alarms
This chapter describes the data alarms generated by the cobas e 411 analyzer system,
together with the cause of each alarm and suggested remedies.
In this chapter
Chapter
10
Introduction .................................................................................................................. 33
List of data alarms ......................................................................................................... 34
Data alarms .................................................................................................................... 36
>AB ......................................................................................................................... 36
>Curr ...................................................................................................................... 36
<SigL ....................................................................................................................... 37
>Test ........................................................................................................................ 37
<Test ........................................................................................................................ 37
AB.E ......................................................................................................................... 38
ADC.E ..................................................................................................................... 38
Cal.E ........................................................................................................................ 38
Calc.? ........................................................................................................................ 39
Cancel [Power Fail/Power Off Cancel] .................................................................. 39
Cancel [E.STOP Cancel] ......................................................................................... 39
Cancel [STOP Cancel] ............................................................................................ 39
Cancel [P.STOP/A.STOP Cancel] .......................................................................... 40
Cancel [S.STOP Cancel] ......................................................................................... 40
Cancel [Recovery Cancel] ....................................................................................... 40
Cancel [Sample ID Error Cancel] .......................................................................... 40
CarOvr .................................................................................................................... 41
ClcT.E ...................................................................................................................... 41
Cell.T ....................................................................................................................... 41
Curr.E ...................................................................................................................... 41
FacA ......................................................................................................................... 42
H ............................................................................................................................... 42
Inc.T ........................................................................................................................ 42
L ................................................................................................................................ 43
Over.E ...................................................................................................................... 43
ReagEx ..................................................................................................................... 43
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Table of contents
Reag.F ...................................................................................................................... 44
Reag.H ..................................................................................................................... 44
Reag.S ...................................................................................................................... 44
Reag.T ..................................................................................................................... 45
Samp.C .................................................................................................................... 45
Samp.S ..................................................................................................................... 45
SLLD.E .................................................................................................................... 46
SLLD.N .................................................................................................................... 46
SysR.S ...................................................................................................................... 46
SysR.T ...................................................................................................................... 47
SysR.U ..................................................................................................................... 47
Data problems without an alarm ................................................................................ 48
Drift of result data ................................................................................................... 48
Erroneous operation ............................................................................................... 48
Poor reproducibility ................................................................................................ 48
Result data at high level ........................................................................................... 48
Result data at low level ............................................................................................ 49
Trouble for each test ............................................................................................... 49
Trouble for all tests ................................................................................................. 49
Instrument problems without an alarm ...................................................................... 49
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10 Data alarms
Introduction
Introduction
If any abnormality occurs while the system is switched on, the system notifies the
operator of the potential problem by issuing an alarm. These alarms comprise data
alarms (referring to irregular measuring results or conditions) and instrument alarms
(referring to irregular system conditions).
Alarm levels
Alarm indication
Warning
Sampling stop
This alarm concerns troubles on the instrument. For the pipetted sample,
measurement is continued.
Stop
Emergency stop
Data alarms are indicated on the Workplace > Data Review screen, on the Test Review
window (Workplace > Data Review > Test Review), and on printed reports. 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
lights up. Its color indicates the alarm level: yellow indicates warning level; red
indicates 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.
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10 Data alarms
Alarm
>AB
>Curr
<SigL
>Test
<Test
AB.E
ADC.E
ADC abnormal
Cal.E
Calc.?
Cancel
Cancel
E.STOP Cancel
Cancel
STOP Cancel
Cancel
P.STOP/A.STOP Cancel
Cancel
S.STOP Cancel
Cancel
Recovery Cancel
Cancel
CarOvr
Cell.T
Cell temperature
ClcT.E
Curr.E
FacA
Inc.T
Incubator temperature
Over.E
Overflow
Reag.F
Reag.H
Reag.S
Reag.T
ReagEx
Reagent expired
Samp.C
Sample clot
Samp.S
Sample short
SLLD.E
SLLD.N
Table D-2
Roche Diagnostics
D-34
10 Data alarms
List of data alarms
Flag
Alarm
SysR.S
SysR.T
SysR.U
Table D-2
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10 Data alarms
Data alarms
Data alarms
For each data alarm, this section gives the nature of the alarm, a fuller description of
the problem, the cause or causes, and appropriate remedies.
>AB
Alarm
Description
Cause
Remedy
>Curr
Alarm
Description
Cause
Remedy
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10 Data alarms
Data alarms
<SigL
Alarm
Description
Cause
Remedy
1 Replace ProCell.
2 Rerun the sample.
3 If the alarm persist, call Technical Support.
>Test
Alarm
Description
Cause
Remedy
<Test
Alarm
Description
Cause
Remedy
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10 Data alarms
Data alarms
AB.E
Alarm
Description
Cause
Remedy
ADC.E
Alarm
Description
Cause
Remedy
ADC abnormal
The analog-digital converter data is abnormal.
o
1 If other instrument alarms exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance > Maintenance and perform the System Reset
maintenance item.
3 If the alarm recurs call Technical Support.
Cal.E
Alarm
Description
Cal.E appears on each control and patient sample for the affected test until the problem is resolved.
Cause
Remedy
Roche Diagnostics
D-38
10 Data alarms
Data alarms
Calc.?
Alarm
Description
Cause
Remedy
Remedy
Roche Diagnostics
Operators Manual Version 1.0
D-39
10 Data alarms
Data alarms
Remedy
Remedy
Roche Diagnostics
D-40
10 Data alarms
Data alarms
CarOvr
Alarm
Description
Cause
Remedy
ClcT.E
Alarm
Description
Cause
Remedy
Cell.T
Alarm
Description
Cause
Remedy
1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the alarm recurs, call Technical Support.
Curr.E
Alarm
Description
Cause
Remedy
Roche Diagnostics
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10 Data alarms
Data alarms
FacA
Alarm
Description
Cause
Remedy
H
Alarm
Description
Cause
Remedy
Inc.T
Alarm
Description
Cause
Remedy
Incubator temperature
Incubator temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.
o
1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the error recurs, call Technical Support.
Roche Diagnostics
D-42
10 Data alarms
Data alarms
L
Alarm
Description
Cause
Remedy
Over.E
Alarm
Description
Cause
Remedy
Overflow
The result is mathematically overflowed.
Wrong calibrator. The data contains more than six digits (including a negative sign
and decimal point).
Minimize the difference in concentration between the sample and the calibrator.
ReagEx
Alarm
Description
Cause
Remedy
Reagent expired
An expired reagent was used for the measurement.
For information only.
Not applicable
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10 Data alarms
Data alarms
Reag.F
Alarm
Description
Cause
Remedy
Assay reagent film detected; Diluent film detected; Pretreatment film detected
Foam or film was detected above reagent.
o
Remove foam or air bubbles with an applicator stick and rerun the affected sample.
Reag.H
Alarm
Description
Cause
Remedy
Reag.S
Alarm
Description
Cause
Remedy
There is no reagent in the reagent pack, the assay reagent volume is insufficient.
1 Verify that reagent, diluent, and pretreatment volumes are adequate. Replace the
low reagent, if necessary, and perform a reagent scan after the replacement.
2 If adequate reagent volumes are present, verify volumes on the Reagent screen.
3 Resume operation and rerun the sample.
4 If the alarm recurs, call Technical Support.
Roche Diagnostics
D-44
10 Data alarms
Data alarms
Reag.T
Alarm
Description
Cause
Remedy
Samp.C
Alarm
Description
Cause
Remedy
Sample clot
A sample clot is detected during aspiration.
o
1 Check sample volume, and fill the required volume in the sample container as
necessary.
2 Check the sample for fibrin. Remove any clots.
3 Rerun the sample.
Samp.S
Alarm
Sample short
e See also: Samp.C on page D-45.
Description
Cause
Remedy
Roche Diagnostics
Operators Manual Version 1.0
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10 Data alarms
Data alarms
SLLD.E
Alarm
Description
Cause
Remedy
SLLD.N
Alarm
Description
Cause
Remedy
SysR.S
Alarm
Description
Liquid short signal is detected, or the liquid level cannot be detected in the ProCell
reservoir.
Cause
The volumes in the system reagent bottles (ProCell and CleanCell) are insufficient.
Remedy
Roche Diagnostics
D-46
10 Data alarms
Data alarms
SysR.T
Alarm
Description
Cause
Remedy
1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the alarm recurs, call Technical Support.
SysR.U
Alarm
Description
Cause
Remedy
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10 Data alarms
Remedy
Avoid leaving the sample in the sample cup for a long time.
Erroneous operation
Cause
Remedy
Poor reproducibility
Cause
Remedy
1 Carry out daily checks and periodic maintenance according to the specified
maintenance procedure.
2 Set a new reagent pack.
3 Set new ProCell or CleanCell bottles.
4 The water quality must be 10 S/cm (microsiemens per cm) or less.
5 Use the recommended reagent handling.
The reagent, control, and standard handling was not done as recommended.
Roche Diagnostics
D-48
10 Data alarms
Instrument problems without an alarm
Remedy
1 If the sample has been loaded for more than two hours, repeat the analysis with a
fresh sample.
2 Set a new ProCell/CleanCell bottle.
3 Use the recommended reagent, control and standard handling.
Remedy
Remedy
Roche Diagnostics
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10 Data alarms
Roche Diagnostics
D-50
Appendix
11
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
11 Appendix
Table of contents
Appendix
In this chapter
Chapter
11
Roche Diagnostics
Operators Manual Version 1.0
E-3
11 Appendix
Table of contents
Roche Diagnostics
Operators Manual Version 1.0
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11 Appendix
Table of contents
Day______________Month______________Year__________
Customer information
Immunoassay problems
dm
Software problems
dm
Instrument problems
dm
Immunoassay problems
Details
Roche Diagnostics
Operators Manual Version 1.0
E-5
11 Appendix
Table of contents
Details
Details
Roche Diagnostics
Operators Manual Version 1.0
E-6
Glossary
12
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
Glossary
2-dimensional barcode -AssayCup disposal opening
Glossary
This glossary is a compendium in which to look up the
meaning of technical terms used in conjunction with the
cobas e 411 automatic analyzer.
Numbers
2-dimensional barcode A type of barcode on reagent
packs, calibrators, and control barcode cards or sheets.
These matrix barcodes, which use PDF417 symbology,
contain more information than traditional linear
barcodes.
A
accuracy The absolute deviation of a result from a predefined target value in percent or absolute units.
action key A key, on the keyboard, that has a predefined function. For example, START, STAT, or
ALARM.
adequate sample volume A starting sample volume
that exceeds the combination of the volume of sample
that will be required for assays and the residual volume
specified for the container that holds the sample.
Roche Diagnostics
Operators Manual Version 1.0
F-3
Glossary
AssayTip -BC
B
backup 1. The saving of data onto supplementary
storage media such as disks or tape. If such data is
required again but is no longer available from the main
storage (instrument hard disk), it can be restored from a
backup copy.
2. An internal instrument-specific process to establish the
data for a backup; only used in a case of routine
instrument break down. See also restore.
Roche Diagnostics
F-4
Glossary
BC card scan -calibration trace
Roche Diagnostics
Operators Manual Version 1.0
F-5
Glossary
Roche Diagnostics
F-6
Glossary
cobas TeleService -data disk
D
DAT Abbreviation for Drugs of Abuse Testing. The
abbreviation DAU is also used.
data alarm An alarm that occurs if a measurement
result or calibration result is abnormal.
data disk 1. The floppy disk or Zip Disk used to store
patient data.
2. The floppy disk contains files that enable
Roche Diagnostics
Operators Manual Version 1.0
F-7
Glossary
Roche Diagnostics
F-8
Glossary
duplicate limit -functional sensitivity
E
ECL Abbreviation for electrochemiluminescence, the
detection technology used on immunoassay analyzers.
emergency stop An instrument alarm level that
immediately stops all instrument functions.
electromotive force (EMF) The physical principle
that provides the basis for electrolyte measurement.
endpoint assay An analytical technique taking
measurements after a reaction is completed or has been
halted.
error handling A process during which the analyzer
attempts to recover from an error condition (for
example, an AssayTip is not picked up from the
magazine). If the analyzer cannot successfully recover
from error, an alarm is issued and the instrument is
halted.
ESC key The Escape key on a computer keyboard
typically used to close a window in the software.
E-stopped A status indicating that the system has
performed an emergency stop (E. Stop). This could be
due to hardware failure or because any of the safety
devices have requested an emergency stop. The system
requires either complete power off, or at least
initialization, to resume normal operation.
F
FDA Abbreviation for Food and Drug Administration.
A US government-controlled agency responsible for
regulating diagnostic and pharmaceutical products.
FIFO Abbreviation for first in, first out. A logistic
process for handling goods or data.
filter A process that sorts data for viewing,
documenting, or printing according to pre-defined
criteria
first registration The date and time when a reagent
pack or sample was successfully recognized by the
barcode reader for the very first time
fixing knob A screw lid that fixes the reaction disk.
flag An identifier used to call an operator's attention to
a result.
float sensor A sensor that detects the surface of
solutions. The sensor position moves up and down
depending on the surface level.
front access panel A door behind which the floppy
disk drive and solid waste tray are located.
function key 1. An analyzer button that an operator
can use to control various analyzer actions (for example,
moving specific items), depending on the current
operational mode.
2. Any one of a set of keys (F1 to F12), located along the
top of the keyboard, used to enter a specific command.
functional sensitivity The concentration of an analyte
at which a pre-defined level of imprecision is obtained.
Roche Diagnostics
Operators Manual Version 1.0
F-9
Glossary
G
global action key A keyboard key that remains active
on all screens
global button A button that allows access to the global
software screens and that can be used at any time.
gripper A technical device that transports AssayCups
and AssayTips to their required destination on the
analyzer (for example, to the incubator). The gripper
moves in three directions (X, Y, and Z).
I
IA Abbreviation for immunoassay.
IC Abbreviation for immunochemistry.
ID A unique alphanumerical set of data that clearly
identifies a patient sample or rack. Also known as an ID
no.
H
hardware (HW) The mechanical and electrical
components of a computer and its peripheral devices.
Roche Diagnostics
F-10
Glossary
intranet -master calibration
L
lab automation The process of managing the entire
analytical process with minimal operator intervention.
LDL Abbreviation for lower detection limit.
See analytical sensitivity.
level detection A check for the availability of sufficient
liquid in a container.
LIMS Abbreviation for Laboratory Information
Management System. See LIS.
linear barcode A conventional one-dimensional
barcode with limited data capacity.
liquid level detection (LLD) The ability of an
analytical instrument to sense liquid by using the sample
or reagent probes.
liquid waste container A reservoir for liquid waste
generated by an analyzer; its size and location vary
between instruments.
LIS Abbreviation for Laboratory Information System. A
clinical laboratory computer system for the management
and storage of patient data and results. An LIS
communicates with analytical instruments.
list box On a screen, a type of box that lists available
choices: for example, a list of available tests from which
the operator can choose.
loader A section of an analyzer that hold trays and racks
waiting to be processed. Also known as the input buffer
or the A-line.
M
maintenance item A maintenance procedure
performed by the system or the operator.
maintenance key A button for position movement,
used for a probe position check.
maintenance procedure A procedure that must be
performed on a regular basis (for example daily, weekly,
monthly, or every three months) to secure reliable
operation of the analyzer.
manual dilution An off-system, pre-analytical step
performed by laboratory staff to reduce the analyte
concentration in a sample.
master calibration A reference standardization that
uses master test kit reagents and certified reference
standard material (for example, World Health
Organization reference material) measured at Roche
Diagnostics. The resulting reference standard curve,
typically using 10 to 12 points, is the basis for the
production of in-house master calibrators.
Roche Diagnostics
Operators Manual Version 1.0
F-11
Glossary
N
NaOH-D A detergent used in cell wash and probe wash.
nipple A part for connecting a syringe and the flow
path.
non-barcode mode A mode of instrument operation
during which the instrument identifies samples by using
the rack and position numbers.
normal range See expected values.
O
onboard 1. A technical device or function that is part of
the analytical instrument and can be used by the
instrument at any time.
2. The availability of reagents and consumables on an
analytical instrument for use at any time.
Roche Diagnostics
F-12
Glossary
one-way serial processing -plunger
P
parallel interface The interface (Centronics type)
through which the analyzer can be connected to an
external printer.
Roche Diagnostics
Operators Manual Version 1.0
F-13
Glossary
prozone The lack of agglutination in an antibodyantigen mixture where the concentration of antibody is
high. The antibody excess leads to the formation of small
complexes that do not clump to form visible
agglutination. Agglutination occurs if the sample is
subsequently diluted. The cobas product range can
identify the presence of prozone phenomena by
determining the change in test sample absorbance when
additional antigen is added in a separate pipetting step.
Q
QA Abbreviation for quality assurance. All the planned
and systematic activities implemented within the quality
system and demonstrated as needed to provide adequate
confidence that an entity will fulfill requirements for
quality.
QC Abbreviation for quality control. The operational
techniques and activities that are used to fulfill
requirements for quality.
QC error An alarm generated in real-time when either a
low value or a high value exceeds the limit of 3SD (QC
error 1) or 2.5 SD (QC error 2).
qualitative assay An assay that does not allow the
determination of the concentration of an analyte, only a
classification of the analyte (for example, positive or
negative).
qualitative measurement The determination of a
substance without calculating and reporting the
concentration with a qualitative assay.
quantitative assay An assay that allows the
determination of the concentration of an analyte.
quantitative measurement The determination of a
substance by calculating and reporting the concentration
with a quantitative assay.
Roche Diagnostics
F-14
Glossary
query download -recalibration
Roche Diagnostics
Operators Manual Version 1.0
F-15
Glossary
S
S. Stop button Abbreviation for sampling stop. A
button used to stop the pipetting of samples but process
already scheduled activities without interruption or loss.
S.Stop Abbreviation for sampling stop. A system
operating mode in which no new samples are pipetted,
but samples already pipetted will be completed without
interruption or loss.
S/R arm See sample/reagent arm.
Roche Diagnostics
F-16
Glossary
sample probe -solid waste tray
Roche Diagnostics
Operators Manual Version 1.0
F-17
Glossary
standard -tip
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.
TDM Abbreviation for Therapeutic Drug Monitoring.
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).
text box A box, on a screen, where a user can type
information or a command.
time-out calibration An instrument mode that
automatically generates a calibration request after a predefined interval.
tip See AssayTip.
Roche Diagnostics
F-18
Glossary
tip eject station -web tunnel
U
ultrasonic unit A mechanical unit, in a waterproof
pack, that generates ultrasound used to stir samples.
W
WAM Workarea management: PC-based software that
controls and monitors sample tracking and offers
extended data management for a defined workarea in a
clinical laboratory environment.
waste Anything discarded by the analyzer; waste can be
liquid or solid.
waste solution reservoir Container that collects
reaction waste.
water level sensor A sensor that monitors the water
level of temperature-controlled water.
Roche Diagnostics
Operators Manual Version 1.0
F-19
Glossary
Roche Diagnostics
F-20
Index
Index
Index
Symbols
<SigL (data alarm), D-37
<Test (data alarm), D-37
>AB (data alarm), D-36
>Curr (data alarm), D-36
>Test (data alarm), D-37
replacing, B-30
tray positions, A-90
Assigning
calibrator positions, B-104
control positions, B-104
Automatic Printout area options, B-85
A
AB level check error (data alarm), D-38
AB level range over (data alarm), D-36
AB.E (data alarm), D-38
Abbreviations, 10
Abnormal reagent disk temperature (data alarm), D-45
Access levels, software screens, A-66
Accumulating QC results, B-41
ADC abnormal (data alarm), D-38
ADC.E (data alarm), D-38
Administrator logon, A-66
Alarm screen
reviewing, B-17
Alarm types, D-5
Alarms, issued by the system, B-17
A-Line (of rack sampler), A-74
Analyzer
components, A-71
dimensions, A-37
safety labels, A-18
troubleshooting, D-14
unit, A-30
Analyzer compartments
cleaning, C-36, C-39
removing condensation, C-14
Approvals, instrument, 2
Approved parts, A-13, A-23
Archiving sample data, B-99
Assay calibration, troubleshooting, D-25
Assay reagent film detected (data alarm), D-44
Assay reagent hovering (data alarm), D-44
Assay reagent short (data alarm), D-44
AssayCup trays
replacing, B-30
troubleshooting, D-18
AssayCups
disposal opening, A-91
inventory, B-20, B-21
tray positions, A-90
AssayTip trays
replacing, B-30
troubleshooting, D-18
AssayTips
inventory, B-20, B-21
B
Barcode card reading station, A-84
Barcode cards, calibrator, A-49
Barcode labels
applying correctly, B-94
calibrator, A-49
control, A-50
reagent, A-46
Barcode readers
rack, A-83
sample, A-80
Barcodes
supported symbologies, A-41
use of check digits, A-13
B-Line (of rack sampler), A-75
Boxes
list, A-63
text, A-64
Bubbles, in syringes, D-23
Buttons
global, A-65
options, A-64
standard, A-64
types, A-64
C
Cal.E (data alarm), D-38
Calc.? (data alarm), D-39
Calc.Test Error (data alarm), D-41
Calculated tests, programming, B-115
Calculation not possible (data alarm), D-39
Calibration
assay troubleshooting, D-25
measuring, B-36
performing, B-32
validating, B-38
Calibration result abnormal (data alarm), D-38
Calibration settings, changing, B-118
Calibration/QC Load List
in daily operation, B-23
loading calibrators, B-32
loading controls, B-32
Roche Diagnostics
Operators Manual Version 1.0
G-3
Index
printing, B-23
Calibrators
assigning positions, B-104
barcode cards, A-49
kits, A-48
loading, B-32
preparing, B-32
troubleshooting, D-11
Cancel [E.STOP Cancel] (data alarm), D-39
Cancel [P.STOP/A.STOP Cancel] (data alarm), D-40
Cancel [Power Fail/Power Off Cancel] (data alarm),
D-39
Cancel [Recovery Cancel] (data alarm), D-40
Cancel [S.STOP Cancel] (data alarm), D-40
Cancel [Sample ID Error Cancel] (data alarm), D-40
Cancel [STOP Cancel] (data alarm), D-39
Canceling print jobs, B-111
Cap open/close mechanism, reagent, A-86
CarOvr (data alarm), D-41
Cell temperature (data alarm), D-41
Cell.T (data alarm), D-41
Checking
liquid waste container, B-27
system alarms, B-17
system water container, B-27
Checks, final power off, B-90
Circuit breaker
main, A-35
rack sampler, A-36
ClcT.E (data alarm), D-41
CleanCell
cleaning compartments, C-36
inventory, B-20
preventing evaporation, B-88
use, A-100
Cleaning
CleanCell compartments, C-36
liquid flow path, C-22
liquid waste container, C-33
microbead mixer, C-35
ProCell compartments, C-36
reagent probe, C-12
reagent rotor/compartment, C-39
rinse stations, C-19
sample probe, C-12
sample/reagent probe, C-12
sipper probe, C-15
Clean-Liner, solid waste, A-96
C-Line (of rack sampler), A-77
Compartments
See, Analyzer compartments
Consumables
loading during operation, B-79
replacing, B-23
Consumables area, A-89
Contact addresses, 3
Containers
direct liquid drain, A-93
liquid waste, A-92
solid waste, A-96
system water, A-92
Continuous loading
using multiple disk mode, B-62
using rack systems, B-62
using single disk mode, B-60
Control kits, A-50
Control unit, A-34, A-53
components, A-55
specifications, A-44
Control values, editing, B-109
Controls
assigning positions, B-104
loading, B-32
measuring, B-36
preparing, B-32
troubleshooting, D-11
Copyrights, 2
Cups
See, AssayCups
Curr.E (data alarm), D-41
D
Daily Alarm Trace reports, printing, B-112
Daily maintenance, C-12
Daily Maintenance button, operation, B-22
Daily operation
routine operation, B-31
work flow, B-11
Data
post-operation management, B-87
storage, A-58
Data alarms
<SigL, D-37
<Test, D-37
>AB, D-36
>Curr, D-36
>Test, D-37
AB level check error, D-38
AB level range over, D-36
AB.E, D-38
abnormal reagent disk temperature, D-45
ADC abnormal, D-38
ADC.E, D-38
assay reagent film detected, D-44
assay reagent hovering, D-44
assay reagent short, D-44
Cal.E, D-38
Calc.?, D-39
Calc.Test Error, D-41
Roche Diagnostics
G-4
Index
E
Editing control values, B-109
Electrical specifications, A-38
Electromagnetic compatibility, A-23
EMC
See, Electromagnetic compatibility.
Emptying
solid waste, B-29
solid waste tray, C-42
Environmental conditions, A-39
Erroneous operation, D-48
Evaporation of system reagents, preventing, B-88
Extended shutdown, C-44
F
FacA (data alarm), D-42
False measurements, troubleshooting, D-24
Final power off checks, B-90
Finalization maintenance, C-30
Flash memory, A-58
Roche Diagnostics
Operators Manual Version 1.0
G-5
Index
G
Global buttons, A-65
Gripper unit, A-90
Guidance prompt, A-61
H
H (data alarm), D-42
Help
See, Online Help
Host interface, A-59
I
IEC 61010 (noise levels), A-39
Inc.T (data alarm), D-42
Incubation, specifications, A-43
Incubator temperature (data alarm), D-42
Incubator, description, A-97
Input buffer (of rack sampler), A-74
Inserts, package, A-47
Installation, safety precautions, A-8
Installing
non-Roche controls, B-107
Roche controls, B-106
Instrument
approvals, 2
dimensions, A-37
troubleshooting, D-11, D-14
Instrument factor A reset (data alarm), D-42
Intended use, 2
Interface
host, A-59
USB, A-58
Inventory
AssayCups, B-20, B-21
AssayTips, B-20, B-21
CleanCell, B-20
ProCell, B-20
solid waste, B-20
Inventory area, B-20
K
Keyboard
See, Software keyboard
Kits
calibrator, A-48
controls, A-50
reagent, A-46
L
L (data alarm), D-43
Labels, reagent barcode, A-46
License, 3
Liner
See, Clean-Liner
Liquid flow path cleaning, C-22
Liquid waste
container, A-92
direct drain, A-93
specifications, A-40
Liquid waste container
checking, B-27
cleaning, C-33
List boxes, A-63
Load list, reagents, B-23
Loading
calibrators, B-32
consumables during operation, B-79
continuous, using multiple disk mode, B-62
continuous, using rack systems, B-62
continuous, using single disk mode, B-60
controls, B-32
Logging on, B-16
Low signal level (data alarm), D-37
M
Main circuit breaker, A-35
Maintenance, C-3
as needed, C-30
cleaning liquid waste container, C-33
cleaning reagent rotor/compartment, C-39
cleaning the CleanCell compartments, C-36
cleaning the microbead mixer, C-35
cleaning the ProCell compartments, C-36
cleaning the rinse stations, C-19
cleaning the sample/reagent probe, C-12
cleaning the sipper probe, C-15
daily, B-87, C-12
emptying the solid waste tray, C-42
every two months, C-24
every two weeks, C-19
finalization maintenance, C-30
items, C-6
liquid flow path cleaning, C-22
performing, C-6
procedures, C-5
protecting the measuring cell, C-44
replacing the pinch valve tubing, C-24
weekly, C-15
Maintenance log, C-9
Maintenance schedule, C-8
Measurement range
lower (data alarm), D-37
upper (data alarm), D-37
Measurements, troubleshooting false values, D-24
Roche Diagnostics
G-6
Measuring
additional routine samples, B-60
calibrators, B-36
controls, B-36
Measuring area, components, A-97
Measuring cell current check (data alarm), D-41
Measuring cell current range over (data alarm), D-36
Measuring cell, protecting during extended shutdown,
C-44
Measuring system, specifications, A-44
Memory
cards, A-58
saving space, B-22
Menu tabs, A-63
Microbead mixer
cleaning, C-35
description, A-86
rinse station, A-87
Mixer
See, Microbead mixer
Monitor, touchscreen, A-55
N
Noise levels (IEC 61010-1), A-39
Non-Roche controls, installing and defining, B-107
O
Online Help, A-67
Operation
overview, B-11
System Overview screen, B-18
Operation switch, A-35
Operator, responsibility for troubleshooting, D-7
Operators Manual
conventions used, 9
finding information, 7
version, 2
Option buttons, A-64
Organic solvents, safety precautions, A-15
Output buffer (of rack sampler), A-76
Outside expected higher value (data alarm), D-42
Outside expected lower value (data alarm), D-43
Over.E (data alarm), D-43
Overflow (data alarm), D-43
P
Package inserts, A-47
Parts, approved, A-13, A-23
Patents, 3
Patient programming
calculated tests, B-115
interfaced, barcoded samples (disk systems), B-45
Index
Roche Diagnostics
Operators Manual Version 1.0
G-7
Index
ProCell
cleaning compartments, C-36
inventory, B-20
preventing evaporation, B-88
use, A-100
Programming
See, Patient programming
Prompt, guidance, A-61
PSM (Pre-Analytic Systems Manager), 1-7, A-27
Q
QC
accumulating results, B-41
activating a test, B-36
measuring, B-36
performing, B-32
R
Rack barcode reader, A-83
Rack sampler
A-Line, A-74
B-Line, A-75
C-Line, A-77
input buffer, A-74
output buffer, A-76
Rack sampler circuit breaker, A-36
Rack systems, A-28, B-5
Reading station, barcode card, A-84
Reag.F (data alarm), D-44
Reag.H (data alarm), D-44
Reag.S (data alarm), D-44
Reag.T (data alarm), D-45
Reagent
pipetter, A-88
Reagent area, A-72
Reagent barcode labels, A-46
Reagent cap open/close mechanism, A-86
Reagent Detail window (Reagent Overview), B-21
Reagent disk
See, Reagent rotor
Reagent expired (data alarm), D-43
Reagent kits, A-46
Reagent Load list
daily operation, B-22
Reagent load/unload list
printing, B-23
Reagent overview area, B-19
Reagent packs
description, A-46
replacing, B-24
Reagent probe, cleaning, C-12
Reagent rotor, A-85
Reagent rotor/compartment, cleaning, C-39
S
S/R probe
See, Sample/reagent probe
Safety
classifications, A-5
information, A-3
precautions, A-5
Safety labels
analyzer unit, A-18
power supply, A-22
Safety standards, peripheral devices, A-23
Samp.C (data alarm), D-45
Samp.S (data alarm), D-45
Sample area, A-72
Sample barcode reader, A-80
Roche Diagnostics
G-8
Index
Roche Diagnostics
Operators Manual Version 1.0
G-9
Index
T
Tabs, menu, A-63
Technical data, system, A-37
Technical Support
contacting, D-8
information required, D-8
Test settings, changing, B-116
Text boxes, A-64
Throughput rate, A-40
Tips
Inventory, B-21
See, AssayTips
Touchscreen monitor, A-55
TPA (Tripropylamine), A-100
Trademarks, 2
Tray, solid waste, A-96
Trays
See, AssayCup trays
See, AssayTip trays
Tripropylamine (TPA), A-100
Troubleshooting
assay calibrations, D-25
auto dilution not possible, D-30
bubbles in syringes, D-23
calibrator problems, D-11
chemistry problems, D-24
computer problems, D-6
contacting Technical Support, D-8
control problems, D-11
control unit problems, D-6
data backup, D-22
drift, D-24
U
Uploading results manually, B-96
USB interface, A-58
User access levels
See, Access levels
User interface
See, Software basics
V
Validating calibration, B-38
Vessels inventory
See AssayCups, inventory
W
Waste containers
direct liquid drain, A-93
liquid waste, A-92
Waste tray, solid
emptying, C-42
replacing, D-20
Roche Diagnostics
G-10
Index
Waste, solid
emptying, B-29
inventory, B-20
Water container, system, A-92
Water supply, requirements, A-40
Weekly maintenance, C-15
Windows
confirmation type, A-66
description, A-66
Work Flow Guide, preventive action, B-22
Roche Diagnostics
Operators Manual Version 1.0
G-11
Index
Roche Diagnostics
G-12
Notes