User mamual-PC400

Clinical Chemistry Analyzer
User Manual
Ref: 1300029947
Int. Ref. Doc.: RAB281EEN

User Manual
User Manual
Ref: 1300029947 - Int. Ref. Doc.: RAB281EEN
Contents
Foreword..........................................................................................................................................5
1. Document Update.................................................................................................................. 6
2. Legal Information....................................................................................................................8
Introduction................................................................................................................................. 11
1. Warning and Precautions.................................................................................................. 12
2. Operational Conditions...................................................................................................... 16
3. Instrument Overview........................................................................................................... 21
4. Labels and Connections.................................................................................................... 23
5. Printer .......................................................................................................................................32
Specifications.............................................................................................................................33
1. Technical Specifications....................................................................................................34
2. Physical Specifications...................................................................................................... 38
3. Reagent Specifications...................................................................................................... 40
4. Analysis Specifications...................................................................................................... 42
5. Limitations............................................................................................................................... 43
Software......................................................................................................................................... 45
1. Software Overview............................................................................................................... 46
2. Menus Description............................................................................................................... 47
3. Software Buttons Description......................................................................................... 50
4. Using the Software...............................................................................................................57
Quality Assurance................................................................................................................... 61
1. Quality Control Overview...................................................................................................62
User Manual i
2. Quality Control by Control................................................................................................ 63
3. Quality Control by Test.......................................................................................................73
4. Westgard Rules..................................................................................................................... 82
5. Logs............................................................................................................................................86
6. Test Counter (On Request)............................................................................................... 92
Workflow......................................................................................................................................101
1. Sample Materials................................................................................................................ 102
2. Workflow Overview............................................................................................................ 104
3. Start of Day........................................................................................................................... 105
4. Reagent Status.................................................................................................................... 111
5. Calibration and Control.................................................................................................... 114
6. Patient Samples.................................................................................................................. 158
7. Common Tasks in a Working Day................................................................................206
8. End of Day..............................................................................................................................212
Settings......................................................................................................................................... 217
1. Reagent Management...................................................................................................... 218
2. Calibration and Control Configuration.......................................................................232
3. Application Configuration............................................................................................... 252
4. System Configuration....................................................................................................... 301
Maintenance and Troubleshooting.......................................................................... 335

1. Customer Services Overview........................................................................................ 336
2. Maintenance......................................................................................................................... 339
3. Troubleshooting.................................................................................................................. 372
ii User Manual
Alarms............................................................................................................................................399
1. System Warnings and Alarms....................................................................................... 400
2. Sampling Alarms................................................................................................................. 420
3. Analytical and Quality Flags........................................................................................... 423
4. ISE Error Codes................................................................................................................... 448
Description and Technology......................................................................................... 451

1. Instrument Description.....................................................................................................452
2. Data Analysis........................................................................................................................ 466
User Manual iii

iv User Manual
Foreword
1. Document Update.................................................................................................................. 6
1.1. Revisions........................................................................................................................................6
1.2. What's New?..................................................................................................................................6
2. Legal Information....................................................................................................................8
2.1. Declaration of Conformity.............................................................................................................. 8
2.2. Notice of Liability............................................................................................................................8
2.3. Trademarks.................................................................................................................................... 8
2.4. Graphics.........................................................................................................................................8
2.5. Document Symbols........................................................................................................................9
2.6. Typographical Conventions........................................................................................................... 9
2.7. Copyright © 2016 by HORIBA ABX SAS..................................................................................... 10
User Manual 5
Foreword
Document Update
1. Document Update
1.1. Revisions
Reference Internal Reference Software Version Document Date Issued

RAB281AEN RAB281AEN 1.1.X April 2013
RAB281BEN RAB281BEN 1.1.X November 2013
1300015907 RAB281CEN 1.2.X December 2015
1300025147 RAB281DEN 1.2.X June 2016
1300029947 RAB281EEN 1.2.X October 2016
This document applies to the latest software version listed and higher versions.
When a subsequent software version changes the information in this document, a new electronic
edition (USB flash drive and/or online help) is released and supplied by HORIBA Medical.
To update a paper document, please contact your local HORIBA Medical representative.
Documentation instructions (USB flash drive)

To view or to print the user manual or any other document included in the Documentation USB flash
drive, plug it in a USB drive and follow the instructions.
1.2. What's New?
Here is the list of major updates in this document release:
Software Version 1.2.X
Item Description Chapter

Excluded Control When you delete a control result, this one is excluded from To Delete a Control
Results the statistical analyses but it is still present in the Quality Graphs Interpretation
Control. Graphs Interpretation
The excluded control results are symbolized by a red triangle
on the Quality Control graphs, both on screen and on the
printouts.
Sub-Ratio Possibility to add, in an existing ratio, a secondary ratio To Add a Sub-Ratio
calculation using the same tests than the main ratio. To Modify a Sub-Ratio
To Delete a Sub-Ratio
6 User Manual
Foreword
Document Update
User Manual Corrections and Additions
Item Description Chapter

Package Addition of package information. Package
New computer Connections and characteristics of the new computer. Peripherals
Connections
Computer
Characteristics
Tubes Labelling Addition of tubes labelling information. Tubes Labelling Best
Practices
Calibration Results On the calibration results printouts, flagged results are To Print Calibration
Printouts indicated by an asterisk (*) in the column marked F. Results
Documentation USB The Pentra C400 documentation is provided on USB flash To Update the Online
flash drive drive. Help
New reference system Addition of new references for consumables and spare parts. Consumables and
The old references (that contain letters and numbers) are still Spare Parts
indicated, the new references (10-digit numbers) are indicated
in brackets. Both references are functional.
New lamp reference The lamp reference has changed. To Replace the Lamp
New quality control A new procedure to check pipetting accuracy and precision is Performing the
solution added. Precision Test
Instrument The procedure to decontaminate your instrument is updated. To Decontaminate your
Decontamination Instrument
User Manual 7
Foreword
Legal Information
2. Legal Information
2.1. Declaration of Conformity
This product complies with the Standards and Directives named in the Declaration of Conformity.
The latest version of the EC Declaration of Conformity for this product is available on www.horiba-
abx.com/documentation.
2.2. Notice of Liability
The information in this manual is distributed on an "As Is" basis, without warranty. While every
precaution has been taken in the preparation of this manual, HORIBA Medical will not assume any
liability to any persons or entities with respect to loss or damage, caused or alleged to be caused
directly or indirectly by not following the instructions contained in this manual, or by using the
computer software and hardware products described herein in a manner inconsistent with our
product labelling.
2.3. Trademarks
Microsoft and Windows are registered trademarks of Microsoft Corporation.

Other product names mentioned within this publication may be trademarks or registered trademarks
of their respective owners.
2.4. Graphics
All graphics including screens, printouts and photographs are for illustration purposes only and are
not contractual.
8 User Manual
Foreword
Legal Information
2.5. Document Symbols
To alert the operator of potentially hazardous conditions, symbols described in this chapter are
provided wherever necessary throughout the manual.
Emphasizes information that must be followed to avoid hazard to either the operator or the
environment, or both.
Emphasizes information that must be followed to avoid possible damage to the instrument
or erroneous test results.
Emphasizes information that can be helpful to the operator before, during or after a
specific operational function.
Gives a summary of what can be achieved if the task is performed.
2.6. Typographical Conventions
Before you start using this documentation, you should become familiar with the following
typographical conventions.
Indicates, from the main screen, the
sequence of menus you have to go
through to begin the procedure.
Indicates, from the main screen, the

Go in Main menu > Services > Customer Services. sequence of menus you have to go
through.
Used for interface items (buttons,

Press Validate.
check boxes, fields, etc.).
Used for windows titles, dialog boxes

The Shutdown window is displayed.
titles or tabs titles.
External links can be used to retrieve

More information on www.horiba-abx.com/documentation.
information from a web site.
User Manual 9
Foreword
Legal Information
Internal links can be used when

Refer to the Workflow > Start of day chapter. referring to related information
located in another chapter.
The Related information box provides

clickable internal links to navigate
throughout the user manual.
2.7. Copyright © 2016 by HORIBA ABX SAS
All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written
permission of HORIBA Medical.
HORIBA ABX SAS

Parc Euromédecine - Rue du Caducée
B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Phone: +33 (0)4 67 14 15 16
Fax: +33 (0)4 67 14 15 17
10 User Manual
Introduction
1. Warning and Precautions.................................................................................................. 12

1.1. Limited Warranty.......................................................................................................................... 12
1.2. Safety Precautions....................................................................................................................... 13
1.3. Graphics and Symbols.................................................................................................................14
2. Operational Conditions...................................................................................................... 16
2.1. Environment................................................................................................................................. 16
2.2. Location....................................................................................................................................... 16
2.3. Grounding.................................................................................................................................... 17
2.4. Humidity and Temperature Conditions........................................................................................ 17
2.5. Electromagnetic Environment Check...........................................................................................17
2.6. Main Power Supply...................................................................................................................... 18
2.7. Environmental Protection.............................................................................................................18
2.8. Storage Conditions and Transportation.......................................................................................18
2.9. Installation.................................................................................................................................... 19
2.10. Package..................................................................................................................................... 20
3. Instrument Overview........................................................................................................... 21
4. Labels and Connections.................................................................................................... 23

4.1. Serial Number Label.....................................................................................................................23
4.2. Power Supply Connection........................................................................................................... 23
4.3. Fluidic System Connections........................................................................................................ 24
4.4. Peripherals Connections.............................................................................................................. 25
4.5. Warnings and Biological Hazards Labels.................................................................................... 27
4.6. Cassette and Rack Labels........................................................................................................... 30
5. Printer .......................................................................................................................................32
User Manual 11
Introduction
Warning and Precautions
1. Warning and Precautions
Work safety reliability and general characteristics are guaranteed by HORIBA Medical under the
following conditions:
■ User manual must be entirely read, and personnel trained by a HORIBA Medical representative
before attempting to operate the instrument.
■ The user always operates with full knowledge and appreciation of instrument warnings and alarms.
■ Always refer to labelling and HORIBA Medical instructions in order to avoid compromising system
integrity.
This instrument must be operated as instructed in the user manual. Any other use might compromise
system integrity and might be hazardous for the operator.
This instrument complies with Standards and Directives named in the Declaration of Conformity. The
latest version of the Declaration of Conformity for this instrument is available online at www.horiba-
abx.com/documentation.
■ The reagents and accessories stipulated by HORIBA Medical have been validated in
accordance with the European Directive for in vitro medical devices (98/79/EC).
■ The use of any other reagents and accessories may place the performance of the
instrument at risk, thus engaging user responsibility. In this case, HORIBA Medical
takes no responsibility for the device nor for the results rendered.
■ Disposable gloves, eye protection and lab coat must be worn by the operator.
■ Local or national regulations must be applied in all the operations.
■ Mobile phones should not be used in proximity of the instrument.
■ All peripheral devices should comply with relevant standards.
1.1. Limited Warranty
The duration of warranty is stipulated in the Sales conditions associated with the purchase of this
instrument. To validate the warranty, ensure the following is adhered to:
■ The system is operated under the instructions of this manual.
■ Only software or hardware specified by HORIBA Medical is installed on the instrument. This
software must be the original copyright version.
■ Services must be done by recommendation from HORIBA Medical, provided by an authorized
technician using only approved spare parts and at least once per year or more, depending on the
number of samples.
■ The electrical supply of the laboratory adheres to national or international regulations.
■ The system is operated according to HORIBA Medical recommendations.
■ Specimens are collected and stored in normal conditions.
■ Reagents used are those specified or recommended by HORIBA Medical.
■ Proper tools are used when maintenance or troubleshooting operations are performed.
If this instrument has been supplied to you by anyone other than HORIBA Medical or an
authorized representative, HORIBA Medical cannot guarantee this product in terms of
specification, latest revision and latest documentation. Further information may be
obtained from your authorized representative.
12 User Manual
Introduction
1.2. Safety Precautions
1.2.1. Electronic and Moving Parts
The following parts must not be handled or checked by the user:

■ Electrical Power supply
■ Electronic circuit boards
Operator injury may occur from an electric shock. Electronic components can shock and
injure the user. Do not dismantle the instrument nor remove any components (covers,
doors, panels, etc.) unless otherwise instructed within this document.
Danger of explosion if battery is not replaced correctly! When replacing the battery, always
use the same and/or equivalent type recommended by the manufacturer. Dispose of used
batteries according to the manufacturer specific instructions.
Moving parts: It is strictly forbidden to disable sensors as it may cause operator injuries.
Protection covers must not be opened during instrument operations. Opening the doors
and covers during instrument operations triggers the instrument emergency stop.
1.2.2. Biological Hazard
Consider all specimens, reagents, calibrators, controls, etc. that contain human
specimen extracts as potentially infectious! Use established, good laboratory working
practices when handling specimens. Wear protective gear, gloves, lab coats, safety
glasses and/or face shields, and follow other biosafety practices as specified in OSHA
Blood borne Pathogens Rule (29 CFR part 1910. 1030) or equivalent biosafety
procedures.
All accessible surfaces of the instrument can be potentially contaminated by human

specimens. Disposable gloves and lab coat must be worn by the operator. Local and
national regulations must be applied in all the operations.
The manufacturer uses disinfectant products for instrument decontamination and highly recommends
it to decontaminate your instrument. Refer to the Maintenance and Troubleshooting > Maintenance >
Other Procedures > To Decontaminate your Instrument chapter to perform the instrument cleaning
and decontamination procedure.
Related information:
■ To Decontaminate your Instrument, p.368
User Manual 13
Introduction
1.3. Graphics and Symbols
Switch off position Switch on position
Alternating current Manufacturer
This product conforms to the EC

In Vitro Diagnostic medical
Directives named in the Declaration of
device
Conformity
Caution, consult accompanying

Biological hazard
documents
Laser Electrostatic sensitive device
Pinch point! Be careful not to

Low temperature
trap your hands/fingers.
This product should be disposed of and

recycled at the end of the useful life in
accordance with European Directive
Hot surface 2002/96/EC on Waste Electrical and
Electronic Equipment (WEEE) and/or
European Directive 2006/66/EC on
batteries and accumulators.
Notice of environment-friendly
Up
use period
Fragile, handle with care Keep dry
Do not stack Temperature limitation
14 User Manual
Introduction
Batch code Reference Number
Use by Install before
Reagent Buffer
Calibrator Control
Content Single use only
Consult Instruction for Use Packaging recycling mark
Green Dot: participation in RESY: cardboard recycling symbol in

packaging recycling in Germany Germany
ERP (Enterprise Resource

Trademark certification TUV
Planning) Number
User Manual 15
Introduction
Operational Conditions
2. Operational Conditions
2.1. Environment
The operation of the Pentra C400 should be restricted to indoor location use only.
The instrument is operational at an altitude of maximum 3000 m (9840 ft).
The instrument is designed for safety from voltage surges according to INSTALLATION CATEGORY II
and POLLUTION DEGREE 2 (IEC 61010-1).
Please contact your local representative for information regarding operation locations when it does
not comply with the recommended specifications.
2.2. Location
Keep in mind that the instrument weighs approximately 120 kg (265 lb).
To move the instrument, four persons are required.
The lifting handles provided in the installation kit must be used.
■ Place your instrument on a clean and leveled table or workbench.

■ Avoid exposure to sunlight.
■ Place your instrument where it is not exposed to water or vapor.
■ Place your instrument where it is not exposed to dust.
■ Avoid direct exposure to air conditioner.
■ Place your instrument where it is free from vibration or shock.
■ Place your instrument where an independent power receptacle can be used.
■ Use a receptacle different from the one used by a device that easily generates noise such as a
centrifuge, etc.
■ Provide a space of at least 20 cm (7.9 in) at the back of the instrument for a proper ventilation.
■ Make sure to provide enough space to open the main cover easily. The instrument height is
approximately 63 cm (24.8 in) closed cover and 105 cm (41.3 in) open cover.
■ Make sure to provide enough space on both sides of the instrument to access the computer
connections and power supply connection.
16 User Manual
Introduction
The Power switch and Power supply connection should always be accessible. When
positioning the system for operational use, leave the required amount of space for easy
access to these items.
2.3. Grounding
Proper grounding is required when installing the system. Check the wall outlet ground (earth) for
proper grounding to the facilities electrical ground. If you are unsure about the outlet grounding,
contact your facilities engineer to verify the proper outlet ground.
2.4. Humidity and Temperature Conditions
Instrument operating temperature: from +15°C (+59°F) to +32°C (+90°F). If the instrument is stored
at a temperature lower than +10°C (+50°F), it should stand for one hour at normal room temperature
before use.
Humidity Conditions: Relative humidity of 20% - 85% maximum, without condensation.
Temperature gradient: 2°C (3.6°F) per hour.
2.5. Electromagnetic Environment Check
The instrument has been designed to produce less than the accepted level of electromagnetic
interference in order to operate in conformity with its destination, allowing the correct operation of
other instruments also in conformity with their destination.
In case of suspected electromagnetic noise, make sure that the instrument has not been placed in the
proximity of electromagnetic fields or short wave emissions, e.g. Radar, X-rays, Scanners, Cell
phones, etc.
Do not perform analysis while cover is open or not correctly fixed. Electromagnetic noise
can affect the data or disrupt a nearby instrument.
User Manual 17
Introduction
2.6. Main Power Supply
It is recommended to install the system on UPS (Uninterruptible Power Supply).
Grounding is required. Make sure the earth wall-plug is correctly connected to the laboratory
grounding system. If there is no such system, a ground stake should be used.
Use only the main supply cable delivered with the instrument.
Main power supply voltage fluctuations must not exceed +/- 10% of the nominal voltage.
■ Always disconnect the system from the supply before servicing.

■ To prevent the risk of electrical shock, do not remove the covers or the back panel.
■ Connections to the supply have to be done by your local representative.
2.7. Environmental Protection
Used Accessories and Consumables Disposal

Disposable used accessories and consumables must be collected by a laboratory specialized in
elimination and recycling of this kind of material according to the local legislation.
Instrument Disposal
This product should be disposed of and recycled at the end of the useful life in
accordance with European Directive 2002/96/EC on Waste Electrical and Electronic
Equipment (WEEE) and/or European Directive 2006/66/EC on batteries and
accumulators.
If any doubt, please contact your local representative.
2.8. Storage Conditions and Transportation
Instrument storage and transportation temperatures: from -20°C (-4°F) to +50°C (+122°F).
Analyzer exposure to rainfall and extended sunlight must be avoided. The outdoors storage of the
analyzer is prohibited.
18 User Manual
Introduction
Before the shipping of an instrument by transporter, whatever the destination, an

external decontamination of the instrument must be carried out.
Keep in mind that the instrument weighs approximately 120 kg (265 lb).
To move the instrument, four persons are required.
The lifting handles provided in the installation kit must be used.
Before instrument removal from use, transportation or disposal, perform a general cleaning and a
draining of your instrument.
■ To Decontaminate your Instrument, p.368
2.9. Installation
A representative will install your instrument, printer and software.
The cooling unit will be installed with your instrument.
For further information about the cooling unit, refer to the cooling unit manual.
Package content:
■ Pentra C400 with or without ISE module (option)
■ Cooling unit
■ Ethylene glycol 2 x 1 L
■ Keyboard (for computer connection)
■ Power supply cable
■ Power strip
■ Software version USB flash drive
■ Reagent Application USB flash drive
■ Documentation USB flash drive
■ Safety Information booklet
■ Installation kit
■ Accessory kit
■ Printer
■ Lifting handles
■ Waste tank
■ Water tank
■ External sample cover
User Manual 19
Introduction
Only HORIBA Medical approved accessories should be used with the Pentra C400.
2.10. Package
Factory package of the analyzer Pentra C400 and its implements consists of firm corrugated
cardboard, polyethylene foil and inner foam plastic framework. Package protects analyzer and its
implements from adverse factors of outside environment.
20 User Manual
Introduction
Instrument Overview
3. Instrument Overview
The Pentra C400 includes several parts.

■ The reagent tray contains 52 positions including 44 refrigerated at 4°C - 10°C (39°F - 50°F) and
eight positions at room temperature. The reagent tray can hold reagent cassettes, reagent racks
and calibrator/control reagent racks. A barcode reader allows reagent identification.
■ The sample tray contains six positions, each position can hold a ten-sample rack for a total
capacity of 60 samples. The sample tray can hold sample racks, sample cup racks and
calibrator/control sample racks. A barcode reader allows sample identification.
■ The sampling system includes a reagent syringe and a reagent needle for pipetting, preheating at
37°C +/- 0.5°C (99°F +/- 0.9°F) and dispensing reagents; a sample syringe and a sample needle
for pipetting and dispensing samples and reagents. Both needles are washed in their respective
wash towers between each sampling.
■ The cuvette changer includes a "new cuvette" holder with a 360-cuvette capacity; a "used
cuvette" holder with a 360-cuvette capacity; a grabber for loading and unloading cuvettes into the
reaction tray.
■ The reaction tray contains six positions, each position can hold a 12-cuvette segment for a total
capacity of 72 cuvettes. The reaction tray temperature is regulated at 37°C +/- 0.2°C
(99°F +/- 0.36°F).
■ The mixer homogenizes reagents and samples in the cuvette. The mixer paddle is washed in its
wash tower between each use.
■ The spectrophotometer measures the solution absorbance from 340 nm to 700 nm.
■ The Ion Selective Electrode (ISE) module (option) is designed to determine sodium, potassium and
chloride concentrations in serum, plasma or urine samples.
User Manual 21
Introduction
Instrument Overview
1 = ISE module
2 = Sample tray
3 = Reagent tray
4 = Sampling system
5 = Mixer
6 = Cuvette changer
7 = Computer connections
8 = Reaction tray
22 User Manual
Introduction
Labels and Connections
4. Labels and Connections
4.1. Serial Number Label
The serial label is located at the back of the instrument.
4.2. Power Supply Connection
The Power switch and Power supply connection should always be accessible. When
positioning the system for operational use, leave the required amount of space for easy
access to these items.
The main power switch is located at the back of the instrument.
User Manual 23
Introduction
1 = Power supply connector

2 = Fuses location
3 = ON/OFF switch
To replace fuses, refer to the Maintenance and Troubleshooting > Troubleshooting > Analyzer Power
Problems chapter.
■ Analyzer Power Problems, p.372
4.3. Fluidic System Connections
1 = Distilled water input

2 = ISE waste output
3 = Waste output
4 = Distilled water level detection
5 = Waste level detection
6 = Cooling unit output
7 = Cooling unit control cable
8 = Cooling unit input
Condensation water evacuation is made by gravity. Make sure that the tube goes
downward and never upward, and that it does not bend.
24 User Manual
Introduction
Condensation water evacuation
Dispose of waste according to your local/national guidelines for biohazard waste disposal.
4.4. Peripherals Connections
1 = Printer connection (parallel port) until the CCC014N (1201848014) computer reference
2 = Host connection
Since the 1300013734 computer reference, the printer should be connected into a USB
port.
Host connection must be set up by an authorized technician.
User Manual 25
Introduction
Computer connections until the CCC014N (1201848014) computer reference
3 = VGA
4 = Mouse
5 = Keyboard
6 = LAN (Local Area Network)
7 = USB
8 = Loudspeaker
Computer connections since the 1300013734 computer reference
3 = USB
4 = LAN (Local Area Network)
5 = USB
6 = Loudspeaker
26 User Manual
Introduction
4.5. Warnings and Biological Hazards Labels
Warning! Biological hazard
On the cuvette changer
Near waste outputs
On the waste tank
Caution, consult accompanying documents
Back of the instrument
Near waste outputs
User Manual 27
Introduction
On the reagent tray cover inside the instrument
Pinch point! Risk to trap hands / fingers
On the cuvette changer
On the reaction tray inner door
Warning! Electrostatic Sensitive Device (ESD)
On the needles
28 User Manual
Introduction
Warning! Hot surface
Near the spectrophotometer lamp inside the instrument
Caution - Class 2 laser radiation
On the sample tray cover
To minimize environmental interferences, the ISE module cover must always be

closed during ISE module operation.
On the ISE module inside the instrument
User Manual 29
Introduction
4.6. Cassette and Rack Labels
Reagent cassette labels

Reagent cassettes are identified by a single barcode which allows the solutions automatic
configuration in the Reagent Configuration menu. However, solutions in an open cassette must be
previously registered in Main menu > Services > Application Configuration > Reagents and
identified by barcode labels (PC400/P400 Open Cas. sticker sheet1 HAX0334 (1207230334) and
PC400/P400 Open Cas. sticker sheet2 HAX0335 (1207230335)) provided by HORIBA Medical.
1 = Barcode label
location
2 = 11.5 mm
Barcode label location
Reagent rack labels

Three rack types are used on the reagent tray, they are differentiated by a color code on the rack
label:
■ White: reagent rack
■ Yellow: calibrator reagent rack
■ Green: control reagent rack
3 = Reagent rack
4 = Calibrator reagent rack
5 = Control reagent rack
Refer to the Maintenance and Troubleshooting > Maintenance > Consumables and Spare Parts
chapter for rack labels references.
Sample rack labels

Four rack types are used on the sample tray, they are differentiated by a color code on the rack label:
■ White: sample rack and sample cup rack
■ Yellow: calibrator sample rack
■ Green: control sample rack
30 User Manual
Introduction
6 = Sample rack
7 = Sample cup rack
8 = Calibrator sample rack
9 = Control sample rack
You should preferably use the sample rack labels from HAX0166 (1207230166) to
HAX0174 (1207230174). Nevertheless, if you use the 2 of 5 interleaved barcode type
without check digit, you must use the sample rack labels from HAX0273 (1207230273) to
HAX0281 (1207230281).
Reagent and calibrator/control stickers

Reagent and calibrator/control stickers (Sticker, Reagent Rack P400 HAX0230 (1207230230)) are
used to identify reagents, calibrators and controls on the racks. They are differentiated by a color
code:
■ White: reagent sticker
■ Yellow: calibrator sticker
■ Green: control sticker
10 = Reagent stickers
11 = Control stickers
12 = Calibrator stickers
■ Consumables and Spare Parts, p.369
■ To Register a Reagent, p.299
User Manual 31
Introduction
Printer
5. Printer
Use the printer supplied or approved by HORIBA Medical.
Contact your local HORIBA Medical representative for more information about printer
compatibility and consumable part numbers.
32 User Manual
Specifications
1. Technical Specifications....................................................................................................34
1.1. Intended Use................................................................................................................................34
1.2. Analysis Methods.........................................................................................................................34
1.3. Throughput...................................................................................................................................34
1.4. Reagent........................................................................................................................................34
1.5. Sample......................................................................................................................................... 35
1.6. Calibrator and Control..................................................................................................................36
1.7. Computer Characteristics............................................................................................................ 36
1.8. Measurement............................................................................................................................... 36
2. Physical Specifications...................................................................................................... 38
2.1. Power Requirements....................................................................................................................38
2.2. Humidity and Temperature Conditions........................................................................................ 38
2.3. Dimension and Weight................................................................................................................. 39
2.4. Sound Level................................................................................................................................. 39
2.5. Water Requirement...................................................................................................................... 39
3. Reagent Specifications...................................................................................................... 40
3.1. Reagent Notices...........................................................................................................................40
3.2. Performance Data........................................................................................................................ 41
3.3. Waste Handling Precautions........................................................................................................41
4. Analysis Specifications...................................................................................................... 42
5. Limitations............................................................................................................................... 43
5.1. Maintenance.................................................................................................................................43
5.2. Interferences................................................................................................................................ 43
User Manual 33
Specifications
Technical Specifications
1. Technical Specifications
1.1. Intended Use
The Pentra C400 system is a fully automated chemistry analyzer using colorimetry, turbidimetry and
potentiometry technologies. It is mostly meant to be used for in vitro diagnostic analyses based on
homogeneous samples such as serum, plasma, urine and whole blood.
1.2. Analysis Methods
The Pentra C400 system allows analysis by:

■ Colorimetry
■ Turbidimetry
■ Potentiometry: direct for serum and plasma, indirect for urine (ISE module option)
1.3. Throughput
■ Up to 300 tests per hour without ISE

■ Up to 400 tests per hour with ISE
1.4. Reagent
Packaging accepted
■ Twin compartment cassette 30/10 from HORIBA Medical
■ Single compartment cassette 100 from HORIBA Medical
■ Reagent rack
34 User Manual
Specifications
On board conditions
■ Capacity: 52 cassettes (39 tests with reagent racks)
■ Temperature: 44 positions refrigerated at 4°C - 10°C (39°F - 50°F) and eight positions at room
temperature
Reagent management
■ Barcode reagent identification
■ Back-up for same reagent
■ Remaining volume calculation
■ Automated reagent on board stability check
Reagent sampling
■ Volume:
■ Minimum: 2 µL with sample needle and 15 µL with reagent needle
■ Maximum: 600 µL
■ Capacitive level detection
■ Insufficient volume detection
■ Reagent preheating at 37°C +/- 0.5°C (99°F +/- 0.9°F)
1.5. Sample
Sample types
■ Serum
■ Plasma
■ Urine
■ Cerebrospinal fluid (CSF)
■ Whole blood
■ Homogeneous liquid
Sample tube types accepted

■ Primary and secondary tubes:
■ 4 and 5 mL (diameter: 13 mm)
■ 7 and 10 mL (diameter: 16 mm)
■ Sample cups (700 µL)
On board conditions
■ Capacity: 60 samples
■ Continuous loading
Sample management
■ Barcode sample identification
■ Tube/cup detector
Sampling
■ Volume:
User Manual 35
Specifications
■ Minimum: 2 µL
■ Maximum: 95 µL for one step and 380 µL for four steps
■ Automatic sample dilution: 1/2 to 1/22500
■ Automatic post-concentration: x2 to x10
■ Capacitive level detection
■ Shock detection
■ Clot detection and insufficient volume detection
1.6. Calibrator and Control
Calibrator/Control positioning
Sample tray and reagent tray
Automatic standard dilution series

■ Main direct dilution ratio: 1/2 - 1/150
■ Main indirect dilution ratio: 1/2 - 1/1508
1.7. Computer Characteristics
The following characteristics concern computers since the 1300013734 reference.

■ Color LCD touch screen: 12 in
■ Operating System: Windows 7™
■ Processor: Atom™ 1.46 GHz
■ RAM (Random Access Memory): 4 GB
■ Hard drive: 250 GB
■ RS232C, RJ45 LAN (Local Area Network), USB 2.0 (7 ports), Audio
1.8. Measurement
Reaction system
■ Reaction cuvettes: disposable acrylic cuvettes
■ Cuvette volume: 150 µL - 600 µL
■ Automatic loading and unloading of cuvettes
■ "New cuvette" holder capacity: 360 cuvettes
■ "Used cuvette" holder capacity: 360 cuvettes
■ Mixing: stirring paddle
■ Reaction temperature: 37°C +/- 0.2°C (99°F +/- 0.36°F), air bath controlled
■ Measurement cycle: 12 seconds
■ Sampling cycle: 12 seconds
■ Reaction time: 12 seconds - 20 minutes
36 User Manual
Specifications
Optical system
■ Measurement principle: absorbance measurement (Bichromatic or Monochromatic)
■ Light source: tungsten-halogen lamp
■ Diffraction: concave reflective grating spectrograph
■ Detector: photodiode array
■ Wavelengths: 340, 380, 405, 420, 455, 490, 505, 520, 550, 560, 580, 600, 620, 660, 700 nm
■ Optical linearity:
Wavelength Linearity Wavelength Linearity Wavelength Linearity

340 nm 2.95 490 nm 2.5 580 nm 2.5
380 nm 2 505 nm 2.5 600 nm 2.5
405 nm 2.5 520 nm 2.5 620 nm 2.5
420 nm 3.5 550 nm 2.5 660 nm 2
455 nm 2 560 nm 2.5 700 nm 2
Algorithms supported
■ Factor
■ Slope average
■ Linear regression
■ Linear interpolation
■ LOGIT/LOG4
■ LOGIT/LOG5
■ Exponential
User Manual 37
Specifications
Physical Specifications
2. Physical Specifications
2.1. Power Requirements
■ Power supply:
■ Instrument: from 100 V to 240 V (+/- 10%), 50 Hz to 60 Hz
■ Cooling unit:
■ 100 V (+/- 10%), 50 Hz to 60 Hz
■ 115 V (+/- 10%), 60 Hz
■ 230 V (+/- 10%), 50 Hz
■ 230 V (+/- 10%), 60 Hz
■ Maximum power consumption:
■ Instrument: 250 VA
■ Cooling unit: 700 W
■ Maximum heat output (instrument + cooling unit): 1940 BTU/h (2010 kJ/h)
Fuses characteristics:
Slow-blow internal fuses having the following characteristics: 2 x T 6.3 A H 250 V (5x20 mm)
Printer
Refer to your printer manual.
2.2. Humidity and Temperature Conditions
Instrument operating temperature: from +15°C (+59°F) to +32°C (+90°F). If the instrument is stored
at a temperature lower than +10°C (+50°F), it should stand for one hour at normal room temperature
before use.
Humidity Conditions: Relative humidity of 20% - 85% maximum, without condensation.
Temperature gradient: 2°C (3.6°F) per hour.
38 User Manual
Specifications
Physical Specifications
2.3. Dimension and Weight
■ Instrument dimensions: 101 x 71 x 63 cm (Width x Depth x Height)

■ Instrument height open cover: 63 cm (24.8 in) closed cover and 105 cm (41.3 in) open cover
■ Instrument weight: 120 kg (265 lb)
■ Cooling unit:
■ Dimensions: 25 x 50 x 60 cm (Width x Depth x Height)
■ Weight: 39 kg (86 lb)
2.4. Sound Level
The maximum sound level is < 60 dB (A).
2.5. Water Requirement
■ De-ionized/distilled water
■ Water specifications:
■ Resistivity > 5 MOhm.cm
■ Conductivity < 0.2 µS/cm
User Manual 39
Specifications
Reagent Specifications
3. Reagent Specifications
In order for the instrument to operate correctly, high-quality reagents must be used.
HORIBA Medical provides a full range of reagents.
These reagents are used for in vitro diagnostic.
All these reagents are manufactured by:

HORIBA ABX SAS
Parc Euromédecine - Rue du Caducée
B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Phone: +33 (0)4 67 14 15 16
Fax: +33 (0)4 67 14 15 17
Refer to the reagent notices for Pentra C400 available on the Pentra C400 reagent online help or
online at www.horiba-abx.com/documentation for all reagent specifications.
The reagents specified for this instrument have been approved in accordance with the
European Directive 98/79/EC (Annex III) for in vitro medical devices.
HORIBA Medical manufactures and markets reagents, calibrators and control bloods
specially designed for use with this analyzer. The use of products not recommended may
give erroneous results or cause instrument operation problems. For all information
regarding the recommended products, please contact your local representative.
3.1. Reagent Notices
Reagent, Control and Calibrator notices/MSDS can be displayed on the Pentra C400
reagent online help. Latest versions of these documents are available online at
www.horiba.com.
40 User Manual
Specifications
Reagent Specifications
3.2. Performance Data
For any information on reagent performance data such as Accuracy, Precision, Linearity,
etc., please refer to the reagent notices for Pentra C400 available on the Pentra C400
reagent online help or online at www.horiba.com.
3.3. Waste Handling Precautions
When disposing of waste, protective clothing must be worn (lab coat, gloves, eye
protection, etc.). Follow your local and/or national guidelines for biohazard waste disposal.
■ At the beginning of each day, before startup, check if the waste container needs to be
emptied.
■ During instrument operation, do not remove the liquid waste tube under any
circumstance.
■ If required, waste can be neutralized before being discarded. Follow your laboratory protocol when
neutralizing and disposing of waste.
■ Dispose of the waste container according to your local and/or national regulatory requirements.
User Manual 41
Specifications
Analysis Specifications
4. Analysis Specifications
Items Specifications
Number of applications Up to 999 applications
Reference range Three ranges: Man/Default, Woman, Child (< 12 years)
Rerun range Three ranges: Man/Default, Woman, Child (< 12 years)
Calibrators Unlimited number of calibrators
Controls Unlimited number of controls
Ratio Up to 200 ratios
Profile Unlimited number of profiles
Patient orders Up to 60 samples on board, continuous loading
Patient, calibration and control results Up to 100000 results in current database, unlimited results archiving
42 User Manual
Specifications
Limitations
5. Limitations
5.1. Maintenance
In the Maintenance and Troubleshooting section, specific maintenance procedures are listed. The
maintenance procedures identified are mandatory for proper use and operation of the Pentra C400.
Failure to execute any of these recommended procedures may result in poor reliability of
the system.
5.2. Interferences
The known interfering substances for each reagent are listed in the corresponding reagent notice
available on the Pentra C400 reagent online help or online at www.horiba.com.
User Manual 43
Specifications
Limitations
44 User Manual
Software
1. Software Overview............................................................................................................... 46
2. Menus Description............................................................................................................... 47
3. Software Buttons Description......................................................................................... 50

3.1. Generic Toolbar............................................................................................................................50
3.2. Menu Access Buttons.................................................................................................................. 52
3.3. Reagent and Sample Trays..........................................................................................................53
3.4. Status Buttons............................................................................................................................. 54
3.5. Contextual Buttons...................................................................................................................... 55
4. Using the Software...............................................................................................................57

4.1. Software Functionalities...............................................................................................................57
4.2. Columns Configuration................................................................................................................ 58
4.3. Scientific Notation........................................................................................................................ 58
4.4. Contextual Help........................................................................................................................... 59
User Manual 45
Software
Software Overview
1. Software Overview
The Pentra C400 includes a control station with a software installed on the embedded computer. The
touch screen allows you to navigate easily in the application.
The main menu includes the following items:

■ (1) The generic toolbar (top of the screen), present on all the screens.
■ (2) The menu access buttons (both sides of the screen), to enter submenus.
■ (3) The reagent and sample trays (middle of the screen).
■ (4) The status buttons (bottom of the screen).
■ (5) The information bar (bottom of the screen), which indicates the current software version, the
current menu in use and the date and time.
Either pressing the screen or using a computer mouse activates the keys.
46 User Manual
Software
Menus Description
2. Menus Description
Generic toolbar
Start Access rights:
User/Admin/Sales/Tech
Pause
Admin/Sales
Test Result
Admin/Sales/Tech
Sampling Exception
Test Review Sales/Tech
Error Report
Tech
Sequencing
Tray
Reagent Configuration
Configuration
Reagent Help
Stop Audible Alarm
Exit/Back
Data Print/Send to Host
All
Warning
System Warnings
Alarm
Alert
Help
Stop/Startup
User Manual 47
Software
Menus Description
Main menu
Patient Access rights:
Worklist Calibration
Admin/Sales
Control
Admin/Sales/Tech
Patient
Sales/Tech
Result Validation Calibration
Tech
Control
Worklist/SID Search
Archives
Search by PID/
Patient Name
Calibration
Calibration/Control Control
ISE Calibration (option)
Logs
Application Configuration
Services Diagnostics
System Configuration
Customer Services
Session
Control Monthly
Annual
Quality Control
Session
Test Monthly
Annual
Cuvette Status
Timing
Reagent supply
Work Balance
Sampling Exception
ISE Module Status (option)
48 User Manual
Software
Menus Description
Services menu
Calibration Access rights:
Reagent
Admin/Sales
Error
Admin/Sales/Tech
Logs System configuration
Sales/Tech
Applications
Tech
Sequencing
Maintenance
Applications
Ratio
Application Configuration Profiles
Incompatibility
Reagents
Diagnostics
Analyser
Local Settings
Host connection
Printer
System Configuration Results validation
Audible alarm
Maintenance
Users
Channel configuration
Cycles
ISE (option)
Customer Services Analyser
Barcode
Test Counter (on request)
User Manual 49
Software
Software Buttons Description
3. Software Buttons Description
Place your mouse pointer over a button to display a tooltip.
3.1. Generic Toolbar
The generic toolbar is located at the top of the screen and is present in all screens.
Generic toolbar buttons

Button Name Action and Description
Start To run patient sample, calibration or control.
To stop samplings on the sample tray.

■ The sample tray LED turns green.
Pause ■ The instrument turns to the "Reagent
processing" status, then to the "Analysing"
status.
To open the Test Review menu.

Test Review Red when a sampling alarm or an analytical flag
is triggered.
Reagent
To open the Reagent Configuration menu.
Configuration
To open the reagent online help (reagent notices/

Reagent Help
MSDS).
To stop the sound alarm in progress

(simple-click).
Stop Audible To switch on/off the sound (double-click).
Alarm ■ Blue when the sound is switched on.
■ Red when the sound is switched off.
■ Dimmed when sound alarms are disabled.
50 User Manual
Software
Instrument
Indicates the instrument status.
status
To open the Shutdown window.

Exit
Displayed only on the main menu.
To go to the previous screen.

Back
Not displayed on the main menu.
Data Print/Send
To print data/to send data to the host.
to Host
To open the System Warnings menu.

■ Red triangle when a system warning or a
System Warnings system alarm is triggered.
■ Red exclamation mark when a maintenance
alert is triggered.
To open the Pentra C400 online help (user

Help
manual).
Stop To stop the instrument in emergency.
To initialize the instrument.

Startup Displayed when the instrument is in "Emergency
Stop" status.
Instrument status
Status Description
"Start-Up" The instrument initializes.
"Ready" The instrument is ready for use.
"Sampling" The instrument is performing samplings and analyses.
"Reagent processing" The instrument is performing samplings only on the reagent tray and is
performing analyses.
"Analysing" The instrument is performing analyses.
User Manual 51
Software
"Emergency Stop" The instrument is stopped by the user or a system alarm.
"Archive" A search for archived results in the archive files saved on the hard disk or
a USB key is in process.
■ To Configure Sound Alarms, p.328
3.2. Menu Access Buttons
The menu access buttons are located on both sides of the main menu. These buttons allow you to
access the main functions of the system.
To open the Worklist menu.

Worklist
To order patient sample, calibration or control.
To open the Result Validation menu.

Result Validation
To validate patient sample, calibration or control.
To open the Archives menu.

Archives
To review archived results.
To open the Calibration/Control menu.

Calibration/Control
To configure calibrators, controls and ISE calibration.
Services To open the Services menu.
To open the Quality Control menu.

Quality Control
To review quality control results.
The Services menu also displays menu access buttons. These buttons give access to five submenus.
To open the Logs menu.

Logs
To consult instrument logs.
52 User Manual
Software
To open the Application Configuration menu.

Application
To configure applications, ratios, profiles and
Configuration
incompatibilities.
To open the Diagnostics menu.

Diagnostics
Only available for technicians (Tech).
To open the System Configuration menu.

System To configure instrument settings.
Configuration Only available for administrators (Admin) or technicians
(Tech).
To open the Customer Services menu.

Customer Services
To perform maintenance and troubleshooting cycles.
3.3. Reagent and Sample Trays
Reagent and sample trays are symbolized in the middle of the main menu. They allow you to visualize
solutions and samples configured on the trays and to access their details.
The colored circle around the reagent tray indicates if the reagent tray is accessible (green) or in
progress (blue).
User Manual 53
Software
The reagent tray contains 52 positions, the status of each solution is indicated by a color code to
which a legend is available by pressing the blue background outside the reagent tray.
For detailed information concerning the solution status, refer to the Workflow > Reagent
Management > Reagent Status > Reagent Tray Description chapter.
You can access solution details by pressing a position on the reagent tray.
The sample tray contains 60 sample positions, the status of each sample is indicated by a color code
to which a legend is available by pressing the blue background inside the sample tray.
For detailed information concerning the sample status, refer to the Workflow > Patient
Samples > Sample Status > Sample Tray Description chapter.
You can access sample rack details by pressing a position on the sample tray.
■ Reagent Tray Description, p.111
■ Sample Tray Description, p.178
3.4. Status Buttons
The status buttons are located at the bottom of the main menu.
To open the Cuvettes window and to check cuvettes.
Green when there is no error on cuvettes.
Red when:
■ The "new cuvette" holder is empty.
■ The "used cuvette" holder is full.
Cuvette ■ There are less than four new cuvettes remaining on the reaction
Status tray.
The Cuvettes window displays:
■ if the "new cuvette" holder is OK or empty,
■ if the "used cuvette" holder is OK or full,
■ the number of cuvettes available on the reaction tray (taking
into account the cuvettes already reserved for ordered tests).
Indicates the measurement start time and finish time during

analyses.
Timing ■ The finish time may change during analyses if samples are
automatically rerun.
■ The finish time is an estimation, and the exact finish time may
slightly vary from the one estimated by the instrument.
54 User Manual
Software
To open the Work Balance menu.

Work
To assess the reagents on board relative to the analyses to be
Balance
performed.
ISE
To check the ISE module status and to open the ISE calibration
Module
results screen.
Status
3.5. Contextual Buttons
Contextual buttons are displayed at the bottom of most screens.

Edit To edit or to modify data.
OK To validate an action.
Cancel To cancel an action.
Details To display more information.
Add new To add new data.
To duplicate data.
Duplicate
To change the lot number of a calibrator or a control.
Target values To display the target values configured for a calibrator or a control.
Position To display the position configured for a calibrator or a control.
Close control To close a control or target values configured for a control.
Delete To delete data.
Select all To select all data.
User Manual 55
Software
Erase To erase all data.
Import To import data.
Export To export data.
Previous To go back to the previous item.
Next To go to the next item.
Order To input data order.
Up To move data up.
Down To move data down.
Rerun To rerun calibration or control.
Close To close the active window.
56 User Manual
Software
Using the Software
4. Using the Software
4.1. Software Functionalities
Buttons
Buttons are not always active, depending on the screen currently displayed, the instrument status or
the login profile.
Tooltips
A tooltip is a short piece of information describing a button. Place your mouse pointer over a button to
display a tooltip.
Dropdown lists
A dropdown list is a list of predefined items. Select one item from the list. Only one item can be
selected from the list.
Check boxes
Check boxes are options you can select. Click the check box to select the option. Several options can
be selected in a list of check boxes.
Radio buttons
Radio buttons are options you can select. Click the radio button to select the option. Only one option
can be selected in a list of radio buttons.
User Manual 57
Software
Using the Software
Data fields
Data fields can have a predefined format, like a date field, or can be empty. Use the keyboard to enter
data.
Scroll bars
Scroll bars can be either vertical or horizontal. Use them to display hidden parts of the screen or a list.
Calendars
Calendars help you to select a date. To choose a month, use the left and right arrows. Then choose
the day. When done, click outside the calendar to close it.
4.2. Columns Configuration
In most of the Pentra C400 software lists (worklist, result list, etc.), you can modify the columns order
and size.
■ Drag and drop the column to move it.
■ Place your mouse pointer between two columns to display a double arrow, and drag the column
separator to change the column size.
The columns configuration is kept in memory.
4.3. Scientific Notation
In the Pentra C400 software, data fields that display a concentration value have the following format:
six numerical characters maximum + decimal position configured in the application with seven
significant digits maximum.
If the concentration value is too high to be displayed with this format, the scientific notation is used.
The value is then displayed: "1.234567E+38" for example.
58 User Manual
Software
Using the Software
4.4. Contextual Help
Help is context-sensitive. The Help button allows you to open a help page corresponding to the
current screen.
If no help is available for the current screen, the home page is displayed.
Contents tab
Once you have entered the embedded help, you can navigate to find further information. In the left
frame, you can expand (+) or collapse (-) the entries of the table of contents. You can also use the
following buttons to navigate through the help application:
displays the table of contents.
hides the table of contents.
synchronizes the table of contents with the page currently displayed in the right frame.
displays the home page.
goes back to the previously visited page.
goes to the next page (based on history).
closes the application.
Index tab
The index provides an alphabetical list of terms. Each index entry is clickable and allows you to
display the page relating to the subject matter.
Search tab
The search functionality allows you to perform a search on all help pages. Matching results are
displayed in the left frame and provide direct links to display the pages required.
User Manual 59
Software
Using the Software
60 User Manual
Quality Assurance
1. Quality Control Overview...................................................................................................62
2. Quality Control by Control................................................................................................ 63

2.1. To Check Control Results by Control.......................................................................................... 63
2.2. Session Values Interpretation...................................................................................................... 64
2.3. Monthly Values Interpretation...................................................................................................... 65
2.4. Annual Values Interpretation........................................................................................................ 66
2.5. Graphs Interpretation................................................................................................................... 67
2.6. To Print Control Results by Control............................................................................................. 69
2.7. To Export Control Results for QCP..............................................................................................71
3. Quality Control by Test.......................................................................................................73

3.1. To Check Control Results by Test............................................................................................... 73
3.2. Session Values Interpretation...................................................................................................... 74
3.3. Monthly Values Interpretation...................................................................................................... 75
3.4. Annual Values Interpretation........................................................................................................ 76
3.5. Graphs Interpretation................................................................................................................... 77
3.6. To Print Control Results by Test.................................................................................................. 79
4. Westgard Rules..................................................................................................................... 82
5. Logs............................................................................................................................................86
5.1. Calibration.................................................................................................................................... 86
5.2. Reagent........................................................................................................................................87
5.3. Error............................................................................................................................................. 87
5.4. System configuration................................................................................................................... 87
5.5. Applications................................................................................................................................. 88
5.6. Sequencing.................................................................................................................................. 88
5.7. Maintenance.................................................................................................................................90
6. Test Counter (On Request)............................................................................................... 92

6.1. To Check Test Statistics.............................................................................................................. 92
6.2. Test Statistics Interpretation........................................................................................................ 94
6.3. To Check Detailed Test Statistics for One Application................................................................ 95
6.4. Detailed Test Statistics Interpretation.......................................................................................... 97
User Manual 61
Quality Assurance
Quality Control Overview
1. Quality Control Overview
The Quality Control (QC) allows you to check the quality of the measurements performed by the
instrument.
Statistical analyses of control results are performed. These statistical analyses consist in calculating
the average, the standard deviation and the coefficient of variation of the measurements over a
defined period.
Three periods are selectable:
■ the current worklist,
■ a month,
■ a year.
Additionally, Westgard rules may be implemented by the user if required. Westgard rules are detailed
in the Quality Assurance > Westgard Rules chapter, and the procedure to configure them is described
in the Settings > System Configuration > Results Validation > To Configure Controls Automatic
Validation chapter.
A control can control several tests and similarly several controls can control a test. That is why the QC
is done by reviewing either the results and statistical analyses of a selected control for each test
controlled with this control (QC by control) or the results and statistical analyses of all controls used
for a selected test (QC by test).
In addition, the QCP Export tab allows you to export control results for the Quality Control Program
(QCP) of HORIBA Medical.
HORIBA Medical offers an Online Interlaboratory Comparison Program (QCP) which provides internet
access to:
■ Submit Internal Quality Control results online.
■ Monitor analytical performance and compare directly with hundreds of laboratories worldwide.
■ Obtain real time peer group statistical reports from QCP.
More information on http://qcp.horiba-abx.com.
■ Quality Control by Control, p.63
■ Quality Control by Test, p.73
■ Westgard Rules, p.82
■ To Configure Controls Automatic Validation, p.326
■ To Export Control Results for QCP, p.71
62 User Manual
Quality Assurance
Quality Control by Control
2. Quality Control by Control
2.1. To Check Control Results by Control
Follow this procedure to check control results by control over the current worklist, a
month or a year.
Access: Main menu > Quality Control > Control
1. Select a control (and lot number) from the Control dropdown list.
The controls that are expired or closed are not displayed by default in the Control dropdown list.
Only the current controls are displayed in the list. If you want to display all the controls, including
those that are expired or closed, select the All Controls option.
The control expiration date is displayed in the Expiration date field.
2. Press either Session, Monthly or Annual tab.
For the Monthly and Annual tabs, select a month and/or a year from the Month and Year
dropdown lists.
The statistical analyses over the current worklist, a month or a year for each test controlled with
the selected control are displayed in the table at the top of the screen.
3. Select an item from the table to display the detailed control results for a test.
The control results for the selected test are displayed as values (in the table at the bottom of the
screen) and as graphs.
4. Press either the Values, the Graph or the Both tab to display the results as values, graphs or
both.
User Manual 63
Quality Assurance
For detailed information concerning values interpretation or graphs interpretation, refer to

the chapters below:
■ Quality Control by Control > Session Values Interpretation,
■ Quality Control by Control > Monthly Values Interpretation,
■ Quality Control by Control > Annual Values Interpretation,
■ Quality Control by Control > Graphs Interpretation.
■ Session Values Interpretation, p.64
■ Monthly Values Interpretation, p.65
■ Annual Values Interpretation, p.66
■ Graphs Interpretation, p.67
■ To Print Control Results by Control, p.69
2.2. Session Values Interpretation
Access: Main menu > Quality Control > Control > Session
For detailed information concerning the procedure to check control results by control,
refer to the Quality Control by Control > To Check Control Results by Control chapter.
Session Mean table

The Session Mean table displays the statistical analyses over the current worklist for each test
controlled with the selected control.
Heading Description
Test Application local code for the controlled test
N Total number of controls performed over the current worklist
N Calculation Number of controls used for the statistical analyses
Mean Session mean value of control results
SD Session standard deviation of control results
CV Session coefficient of variation of control results
Target Value Control target value
Confidence Range Low and high limit values of confidence range
Tests Details table

The Tests Details table displays the session control results for the selected test.
The results are sorted by run date.
Heading Description
Run Date Date and time of control run
Validator Session Name User name or login used when validating the result
Final Result Final result
64 User Manual
Quality Assurance
Heading Description
Quality flag Quality flag
Flag Analytical flag
If several analytical flags exist, the flag having priority is displayed.
Decision A (Accept) or D (Delete)
Unit Test unit configured in the application
The control results which have been excluded from the Result Validation menu are
grayed.
■ To Check Control Results by Control, p.63
2.3. Monthly Values Interpretation
Access: Main menu > Quality Control > Control > Monthly
Monthly Mean table

The Monthly Mean table displays the statistical analyses over the month for each test controlled with
the selected control.
Heading Description
N Total number of controls performed over the month
Mean Monthly mean value of control results
SD Monthly standard deviation of control results
CV Monthly coefficient of variation of control results
Daily Detail table

The Daily Detail table displays the monthly control results for the selected test.
Heading Description
User Manual 65
Quality Assurance
Heading Description
grayed.
2.4. Annual Values Interpretation
Access: Main menu > Quality Control > Control > Annual
Year Mean table

The Year Mean table displays the statistical analyses over the year for each test controlled with the
selected control.
Heading Description
N Total number of controls performed over the year
Mean Annual mean value of control results
SD Annual standard deviation of control results
CV Annual coefficient of variation of control results
Monthly Detail table

The Monthly Detail table displays the monthly statistical analyses over the year for the selected test.
Heading Description
Save Date Month and year of the displayed statistical analyses
66 User Manual
Quality Assurance
Heading Description
2.5. Graphs Interpretation
Graphs display the control results for the selected test over the current worklist, a month or a year.
For a year, the monthly mean values are displayed. Two graphs are selectable:
■ Accuracy Cumulative Control
■ Precision Cumulative Control
Accuracy Cumulative Control
The Accuracy Cumulative Control graph displays the following data:

■ X-axis: run date,
■ Y-axis: concentration,
■ Blue line: target value,
■ Red lines: low and high limit values of the confidence range.
■ Control results are displayed in green when they are into confidence range or in red when they are
out of confidence range. Click a control result to display the control run date and concentration.
User Manual 67
Quality Assurance
symbolized by a red triangle .
Drag your mouse pointer from left to right to zoom in or from right to left to zoom out.
Precision Cumulative Control
The Precision Cumulative Control graph displays the following data:

■ Blue line: mean value,
■ Yellow lines: mean value +/- 1SD (Standard Deviation),
■ Red lines: mean value +/- 2SD.
■ Control results are displayed in green when they are lower than mean value +/- 1SD, in yellow
when they are lower than mean value +/- 2SD, or in red when they are higher than mean value
+/- 2SD. Click a control result to display the control run date and concentration.
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2.6. To Print Control Results by Control
Follow this procedure to print control results by control over the current worklist, a month
or a year.
1. Select a control (and lot number) from the Control dropdown list.
The controls that are expired or closed are not displayed by default in the Control dropdown list.
Only the current controls are displayed in the list. If you want to display all the controls, including
those that are expired or closed, select the All Controls option.
The control expiration date is displayed in the Expiration date field.
2. Press either Session, Monthly or Annual tab.
For Monthly and Annual tabs, select a month and/or a year from Month and Year dropdown lists.
The results and statistical analyses over the current worklist, a month or a year for each test
controlled with the selected control are displayed.
3. Press Data Print/Send to Host from the generic toolbar.
The Print window is displayed.
4. Configure your printout as follows:

a. Select the Current Control option to print control results of the selected control or the All
Controls with Data option to print control results of all controls having results.
b. Select the printout format from the following options.
■ Standard by Accuracy: To print the statistical analyses and to visualize the mean value
relative to the target value and the low and high limit values of the confidence range.
■ Detailed by Accuracy: To print the detailed control results and to visualize each control
result relative to the target value and the low and high limit values of the confidence range.
■ Detailed by Precision: To print the detailed control results and to visualize each control
result relative to the mean value, the mean value +/- 1SD (Standard Deviation) and the
mean value +/- 2SD.
For the Annual tab, Detailed by Accuracy and Detailed by Precision options are
unavailable.
c. To print the graphs, select Accuracy Graph and/or Precision Graph options.
5. Press OK to validate.
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Printout format: Standard by Accuracy
Printout format: Detailed by Accuracy with Accuracy Graph
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Printout format: Detailed by Precision with Precision Graph
2.7. To Export Control Results for QCP
Follow this procedure to export control results for the Quality Control Program (QCP) of
HORIBA Medical.
Access: Main menu > Quality Control > QCP Export
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1. Select the period as follows:

a. Press the arrow from the From: field to open the calendar. To choose a month, use the left and
right arrows. Then choose the day. When done, click randomly outside the calendar to close it.
b. Press the arrow from the To: field to open the calendar. To choose a month, use the left and
2. Press the Search button:
Results are listed as a table which indicates the control name, the control lot number, the date of
the first result and of the last result, if the control results are selected to be exported.
3. By default, all control results are selected to be exported. If necessary, deselect the control results
that should not be exported.
Press the Select all button to select all the tests or the Deselect all button
to deselect all the tests.
4. Press Export:
A dialog box asks you to confirm that the USB key is in place.
5. Install your USB key on the instrument.
HORIBA Medical recommends you to make sure that all materials like CD-ROM or USB
key used on the Pentra C400 and non-referenced by HORIBA Medical are free of
viruses. These materials must imperatively be cleaned before being used on the
instrument.
A dialog box informs you when the export is completed.
7. Press OK.
The selected control results are saved in an .xml file (one file per control) located in a folder named
"Export" on the USB key.
"Export" folder example
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Quality Control by Test
3. Quality Control by Test
3.1. To Check Control Results by Test
Follow this procedure to check control results by test over the current worklist, a month or
a year.
Access: Main menu > Quality Control > Test
1. Select a test from the Select Test dropdown list.

2. Press either the Session, the Monthly or the Annual tab.
For Monthly and Annual tabs, select a month and/or a year from the Month and Year dropdown
lists.
The statistical analyses over the current worklist, a month or a year for all controls used for the
selected test are displayed in the table at the top of the screen.
3. Select an item from the table to display the detailed control results for a control.
The control results for the selected control are displayed as values (in the table at the bottom of
the screen) and as graphs.
4. Press either the Values, the Graph or the Both tab to display the results as values, graphs or
both.
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For detailed information concerning values interpretation or graphs interpretation, refer to

the chapters below:
■ Quality Control by Test > Session Values Interpretation,
■ Quality Control by Test > Monthly Values Interpretation,
■ Quality Control by Test > Annual Values Interpretation,
■ Quality Control by Test > Graphs Interpretation.
■ Session Values Interpretation, p.74
■ Monthly Values Interpretation, p.75
■ Annual Values Interpretation, p.76
■ Graphs Interpretation, p.77
■ To Print Control Results by Test, p.79
3.2. Session Values Interpretation
Access: Main menu > Quality Control > Test > Session
For detailed information concerning the procedure to check control results by test, refer to
the Quality Control by Test > To Check Control Results by Test chapter.
Session Mean table

The Session Mean table displays the statistical analyses over the current worklist for all controls used
for the selected test.
Heading Description
Name Control name
Lot Control lot number
N Total number of controls performed over the current worklist
Mean Session mean value of control results
SD Session standard deviation of control results
CV Session coefficient of variation of control results
Tests Details table

The Tests Details table displays the session control results for the selected control.
Heading Description
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Heading Description
grayed.
■ To Check Control Results by Test, p.73
3.3. Monthly Values Interpretation
Access: Main menu > Quality Control > Test > Monthly
Monthly Mean table

The Monthly Mean table displays the statistical analyses over the month for all controls used for the
selected test.
Heading Description
Name Control name
Daily Detail table

The Daily Detail table displays the monthly control results for the selected control.
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Heading Description
grayed.
3.4. Annual Values Interpretation
Access: Main menu > Quality Control > Test > Annual
Year Mean table

The Year Mean table displays the statistical analyses over the year for all controls used for the
selected test.
Heading Description
Name Control name
N Total number of controls performed over the year
Mean Annual mean value of control results
SD Annual standard deviation of control results
CV Annual coefficient of variation of control results
Monthly Detail table

The Monthly Detail table displays the monthly statistical analyses over the year for the selected
control.
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Heading Description
Save Date Month and year of the displayed statistical analyses
3.5. Graphs Interpretation
Graphs display the control results for the selected control over the current worklist, a month or a year.
For a year, the monthly mean values are displayed. Two graphs are selectable:
■ Accuracy Cumulative Control
■ Precision Cumulative Control
Accuracy Cumulative Control
The Accuracy Cumulative Control graph displays the following data:
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■ Blue line: target value,
■ Red lines: low and high limit values of the confidence range.
■ Control results are displayed in green when they are into confidence range or in red when they are
out of confidence range. Click a control result to display the control run date and concentration.
Precision Cumulative Control
The Precision Cumulative Control graph displays the following data:

■ Blue line: mean value,
■ Yellow lines: mean value +/- 1SD (Standard Deviation),
■ Red lines: mean value +/- 2SD.
■ Control results are displayed in green when they are lower than mean value +/- 1SD, in yellow
when they are lower than mean value +/- 2SD, or in red when they are higher than mean value
+/- 2SD. Click a control result to display the control run date and concentration.
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3.6. To Print Control Results by Test
Follow this procedure to print control results by test over the current worklist, a month or a
year.
1. Select a test from the Select Test dropdown list.

2. Press either the Session, the Monthly or the Annual tab.
For the Monthly and the Annual tabs, select a month and/or a year from the Month and Year
dropdown lists.
The results and statistical analyses over the current worklist, a month or a year for all controls
used for the selected test are displayed.
4. Configure your printout as follows:

a. Select the Current Control option to print control results of the selected test or the All
Controls with Data option to print control results of all tests having results.
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b. Select the printout format from the following options.

■ Standard by Accuracy: To print the statistical analyses and to visualize the mean value
relative to the target value and the low and high limit values of the confidence range.
■ Detailed by Accuracy: To print the detailed control results and to visualize each control
result relative to the target value and the low and high limit values of the confidence range.
■ Detailed by Precision: To print the detailed control results and to visualize each control
result relative to the mean value, the mean value +/- 1SD (Standard Deviation) and the
mean value +/- 2SD.
For the Annual tab, Detailed by Accuracy and Detailed by Precision options are
unavailable.
c. To print the graphs, select the Accuracy Graph and/or the Precision Graph options.
Printout format: Standard by Accuracy
Printout format: Detailed by Accuracy with Accuracy Graph
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Printout format: Detailed by Precision with Precision Graph
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Westgard Rules
4. Westgard Rules
Westgard rules are additional checks that apply to default controls for validation.
For detailed information concerning the procedure to configure Westgard rules, refer to
the Settings > System Configuration > Results Validation > To Configure Controls
Automatic Validation chapter.
Definitions
■ When configuring a control for a test, the target value and the low and high limit values of the
confidence range are entered. These three values allow you to define the following thresholds:
■ target value +/- 1SD (Standard Deviation),
■ target value +/- 2SD,
where 1SD = (high limit of confidence range - low limit of confidence range) / 4.
■ Control level: Up to three default controls can be configured for a test. Each default control is a
control level for the test.
■ Intra-control rule: The rule applies to the last results of each control level independently of other
control levels.
■ Inter-control rule: The rule applies to the last results of all control levels.
Westgard rules
Westgard rules allow you to characterize whether a control result outside the confidence range is a
random error non specific to the system or if it is due to a problem on the system.
■ If the control result is outside the confidence range and no Westgard rule is true, then the result is
flagged with CONF_RANGE_HIGH_W / LOW_W but the automatic validation is not blocked.
■ If the control result is outside the confidence range and the Westgard rule 1, 2, 3, 4, 5 or 6 is true,
then the result is flagged with CONF_RANGE_HIGH_W1-6 / LOW_W1-6 and the automatic
validation is blocked.
When Westgard rules are enabled, the following rules are checked one after the other.
Starting rule, 12S rule
The last control result is higher than + 2SD or lower than - 2SD.
QC values
26
+ 3SD
24
high limit = + 2SD
22
+ 1SD
Values
20 target value
- 1SD
18
low limit = - 2SD
16
- 3SD
14
1 2 3 4 5 6 7 8 9 10
Runs
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Westgard Rules
■ If true, then the rule 1 is checked.

■ If false, the Westgard rules 1, 2, 3, 4, 5 and 6 are not checked except if the Apply rules 4, 5 and 6
(drift) to values inside confidence range option is enabled.
Rule 1, 13S rule
The last control result is higher than + 3SD or lower than - 3SD.
QC values
26
+ 3SD
24
high limit = + 2SD
22
+ 1SD
Values
20 target value
- 1SD
18
low limit = - 2SD
16
- 3SD
14
1 2 3 4 5 6 7 8 9 10
Runs
■ If true, then the result is flagged with CONF_RANGE_HIGH_W1 / LOW_W1.
■ If false, then the rule 2 is checked.
Rule 2, 22S rule

Intra-control rule: The two last control results are higher than + 2SD or lower than - 2SD.
Inter-control rule: The last results of two different control levels are higher than + 2SD or lower than
- 2SD.
QC values
26
+ 3SD
24
high limit = + 2SD
22
+ 1SD
Values
20 target value
- 1SD
18
low limit = - 2SD
16
- 3SD
14
1 2 3 4 5 6 7 8 9 10
Runs
Rule 3, R4S rule

Intra-control rule: The difference between the two last control results is higher than 4SD.
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Westgard Rules
Inter-control rule: The difference between the last results of two different control levels is higher than
4SD.
QC values
26
+ 3SD
24
high limit = + 2SD
22
+ 1SD
Values
20 target value
- 1SD
18
low limit = - 2SD
16
- 3SD
14
1 2 3 4 5 6 7 8 9 10
Runs
Rule 4, 41S rule

Intra-control rule: The last four control results are higher than + 1SD or lower than - 1SD.
Inter-control rule: The last four control results, regardless of the control level, are higher than + 1SD or
lower than - 1SD.
QC values
26
+ 3SD
24
high limit = + 2SD
22
+ 1SD
Values
20 target value
- 1SD
18
low limit = - 2SD
16
- 3SD
14
1 2 3 4 5 6 7 8 9 10
Runs
Rule 5, 10x rule

Intra-control rule: The last ten control results are all higher than the target value or all lower than the
target value.
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Westgard Rules
Inter-control rule: The last ten control results, regardless of the control level, are all higher than the
target value or all lower than the target value.
QC values
26
+ 3SD
24
high limit = + 2SD
22
+ 1SD
Values
20 target value
- 1SD
18
low limit = - 2SD
16
- 3SD
14
1 2 3 4 5 6 7 8 9 10
Runs
Rule 6, 7T rule
The last seven control results are strictly increasing or decreasing.
QC values
26
+ 3SD
24
high limit = + 2SD
22
+ 1SD
Values
20 target value
- 1SD
18
low limit = - 2SD
16
- 3SD
14
1 2 3 4 5 6 7 8 9 10
Runs
■ If false, then the result is flagged with CONF_RANGE_HIGH_W / LOW_W that means the control
result is outside the confidence range and no Westgard rule is true.
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Logs
5. Logs
Access: Main menu > Services > Logs
Logs list events notified while the instrument is operating. Seven logs are available:
■ Calibration
■ Reagent
■ Error
■ System configuration
■ Applications
■ Sequencing
■ Maintenance
Events are listed in a table format which indicates the event date and time, the user name or login
used when the event occurred, the event name and description except for Error and Sequencing
logs which display specific information.
Events of the last six months are stored from the most recent to the oldest except for the Sequencing
log which displays events of the last seven days from the oldest to the most recent.
5.1. Calibration
Access: Main menu > Services > Logs > Calibration
The Calibration log lists the following events:

■ every calibration validation (either automatic or manual),
■ every calibration deletion,
■ every target value modification.
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Logs
The Calibration log displays the events by test. Select a test from the Name dropdown
list.
5.2. Reagent
Access: Main menu > Services > Logs > Reagent
The Reagent log lists the following events:

■ every cassette or reagent rack loading/unloading,
■ every solution activation/deactivation (either automatic or manual),
■ every cassette deletion.
5.3. Error
Access: Main menu > Services > Logs > Error
The Error log lists the system warnings and alarms triggered while the instrument is operating.
The system warnings and alarms are listed in a table format which indicates the event level (warning
or alarm), the event date and time, the user name or login used when the event occurred, the event
code and message.
For detailed information on system warnings and alarms, refer to the Alarms > System
Warnings and Alarms chapter.
■ System Warnings and Alarms, p.400
5.4. System configuration
Access: Main menu > Services > Logs > System configuration
The System configuration log lists the following events:
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Logs
■ every system parameter modification from the Analyser, the Local Settings and the Results
validation tabs,
■ every host connection modification from the Host connection tab,
■ every printer settings modification from the Printer tab,
■ every modification of the sound alarms configuration from the Audible alarm tab,
■ every maintenance configuration modification from the Maintenance tab,
■ every user account creation, deletion or modification from the Users tab,
■ every modification of the user channels number (configured by your local HORIBA Medical
representative).
5.5. Applications
Access: Main menu > Services > Logs > Applications
The Applications log lists every application addition, deletion or modification.
For an application provided by HORIBA Medical or your local representative, the following
events are specified:
■ every modification of the application version number,
■ every modification of a user parameter.
5.6. Sequencing
Access: Main menu > Services > Logs > Sequencing
The Sequencing tab lists the following events:

■ every reagent needle sampling,
■ every sample needle sampling,
■ every mixing,
■ every cuvette segment loading/unloading.
Events are listed in a table format which are described below.
Reagent Arm
Heading Description
Date Sampling date and time
Nature Sampling nature:
■ for a test: Application local code,
■ for a dilution: Dilution,
■ for a cleaning: Cleaner.
Reagent needle Solution pipetted by the reagent needle
Volume Volume pipetted by the reagent needle (µL)
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Logs
Heading Description
Sampling position Position where the solution is pipetted:
■ on the reagent tray: R (for reagent tray) + position number on the tray +
position number in the cassette or on the reagent rack.
Type Container type where the solution is pipetted:
■ for a cassette: Cassette,
■ for a reagent rack: Rack ID + position number on the reagent rack.
Dispensing position Position where the solution is dispensed:
■ on the reaction tray: C (for cuvette) + position number on the tray +
position number in the cuvette segment.
Sample Arm
Heading Description
■ for an ISE test: ISE,
Sample needle Solution pipetted by the sample needle
Volume Volume pipetted by the sample needle (µL)
H2O Distilled water volume pipetted by the sample needle (µL) to push the sample
volume
■ on the sample tray: S (for sample tray) + rack number + position number
on the rack,
position number in the cassette or on the reagent rack,
■ for a sample tube: Tube,
■ for a sample cup: Sample cup,
■ for a reagent rack or a calibrator/control reagent rack: Rack ID + position
number on the reagent rack,
■ for a cuvette: Cuvette.
position number in the cuvette segment,
■ in the ISE module sample cup: ISE bowl.
Other
Heading Description
Date Date and time of mixing or cuvette segment loading/unloading
Mixing speed Mixing speed used to homogenize solutions into the cuvette
Cuvette loader Cuvette segment loading/unloading: Loading or Unloading + position
number on the tray
Events of the last seven days are stored from the oldest to the most recent.
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Logs
5.7. Maintenance
Access: Main menu > Services > Logs > Maintenance
The Maintenance log lists the maintenance procedures that are performed on the instrument. These
procedures must be configured in Main menu > Services > System Configuration > Maintenance
to be listed in the log.
Most of the maintenance procedures use a software function from the Customer Services menu.
These procedures are automatically notified in the log when they are performed.
Some maintenance procedures do not use a software function. These procedures must be manually
notified in the log when they are performed.
The Maintenance log displays all maintenance procedures by default. You can select a
frequency from the Occurrence dropdown list to display the maintenance procedures by
frequency.
The maintenance procedures are listed in a table format which indicates the event date and time, the
user level, and the user name or login used when the event occurred, the event name and description
and the event comment.
An item in red means that the maintenance procedure has not been performed on time.
■ Configuring Maintenance Alerts, p.329
■ To Add a Maintenance Procedure, p.90
■ To Add a Comment, p.91
5.7.1. To Add a Maintenance Procedure
Follow this procedure to manually notify a maintenance procedure in the log.
When a maintenance procedure (which does not use a software function) is performed on the
instrument, you must manually notify this procedure in the log.
1. Press Add new.

The data capture screen is displayed.
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Logs
2. Select the maintenance procedure from the Event dropdown list.

■ Instrument cleaning and decontamination
■ Filter replacement
■ Glycol level checking
■ Qualitest / Precitest
Only the maintenance procedures which do not use a software function are selectable.
The maintenance procedures which use a software function are automatically notified
in the log when they are performed.
3. Type the event description (255 characters maximum).

4. Add a comment (255 characters maximum).
5.7.2. To Add a Comment
Follow this procedure to add a comment to a maintenance procedure in the log.
1. Select the maintenance procedure in the list.

2. Press Details.
The data capture screen is displayed.
3. Press Edit.
4. Add a comment (255 characters maximum).
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Test Counter (On Request)
6. Test Counter (On Request)
Contact your local HORIBA Medical representative to activate the Test Counter.
The Test Counter allows you to monitor your activity balance.

The tests performed on the instrument since its installation are counted. The Test Counter displays
test statistics for each application over a defined period.
Four periods are selectable:
■ since the instrument installation,
■ a year,
■ a month,
■ a day.
Test statistics give the following data:
■ the number of patient, calibration and control tests,
■ the number of validated results,
■ the number of reruns,
■ the number of deleted results,
■ the number of failed tests.
6.1. To Check Test Statistics
Follow this procedure to monitor your activity balance for all the applications.
Access: Main menu > Services > Customer Services > Test Counter
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1. Select the applications to be displayed from the following options.

■ Residents: To display test statistics for the applications provided by HORIBA Medical or your
local representative.
■ Others: To display test statistics for the user applications.
■ All: To display test statistics for all the applications.
2. Define a period as follows:
a. Select the period from the following options.
■ Since installation: To display statistics of tests performed on the instrument since its
installation.
■ Year: To display statistics of tests performed on the instrument during a year.
■ Month: To display statistics of tests performed on the instrument during a month.
■ Day: To display statistics of tests performed on the instrument during a day.
b. Select the year, the month and/or the day.
Results are displayed in the test statistics table.
3. To display cumulative test statistics for several applications, select the applications in the test
statistics table.
Press Select all to select all the applications or Deselect all to deselect all the
applications.
Results are displayed in the cumulative test statistics table.
4. To print test statistics for several applications, proceed as follows:

a. Select the applications in the test statistics table and press Data Print/Send to Host from the
generic toolbar.
b. Select the Test counter. Selected channels option to print test statistics for the selected
applications or the Test counter. All channels option to print test statistics for all the
applications.
c. Press OK to validate.
For detailed information concerning test statistics interpretation, refer to the Test Counter
(On Request) > Test Statistics Interpretation chapter.
■ Test Statistics Interpretation, p.94
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6.2. Test Statistics Interpretation
For detailed information concerning the procedure to check test statistics, refer to the Test
Counter (On Request) > To Check Test Statistics chapter.
Test statistics table

The test statistics table displays statistics of tests performed on the instrument during the defined
period. Results are sorted by application.
Heading Description
Selection To select or to deselect an application.
If selected, the tests for this application are taken into account in the
cumulative test statistics table.
Channel # Application channel number
Current code Application local code
Control Number of control tests performed
Calibrator Number of calibration tests performed
Patient Number of patient tests performed
Reportable Number of patient test results having the decision Accept or Modify
Rerun Number of patient tests with a rerun (manual or automatic)
% rerun Percentage of reruns compared with the number of patient test results
having the decision Accept or Modify (Reportable column)
Reportable deleted Number of patient test results having the decision Delete
Failure Number of failed patient tests, calculated as follows:
Failure column = Patient column - (Reportable + Rerun + Reportable
deleted) columns.
Total Total number of patient, calibration and control tests
An item in gray means that the application is deleted.
Cumulative test statistics table

The cumulative test statistics table displays statistics of all tests for the applications selected in the
test statistics table (Total selected line) and for all the applications (Total all line).
Heading Description
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Heading Description
deleted) columns.
■ To Check Test Statistics, p.92
6.3. To Check Detailed Test Statistics for One Application
Follow this procedure to monitor your activity balance for one application.
Access: Main menu > Services > Customer Services > Test Counter
1. Select the applications to display from the following options.

■ Residents: To display test statistics for the applications provided by HORIBA Medical or your
local representative.
■ Others: To display test statistics for the user applications.
■ All: To display test statistics for all the applications.
2. Define a period as follows:
a. Select the period from the following options.
■ Since installation: To display statistics of tests performed on the instrument since its
installation.
■ Year: To display statistics of tests performed on the instrument during a year.
■ Month: To display statistics of tests performed on the instrument during a month.
b. Select the year and/or the month.
Results are displayed in the test statistics table.
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3. Select the application in the test statistics table and press Detail.
Results are displayed in the detailed test statistics table.
4. To sort the results, select either the Year, the Month or the Day option.
The selectable options depend on the defined period.
5. To display cumulative test statistics for several periods, select the periods in the detailed test
statistics table.
Press Select all to select all the periods or Deselect all to deselect all the periods.
Results are displayed in the cumulative test statistics table.
6. To display detailed test statistics for several periods as a graph, select the periods in the detailed
test statistics table (100 periods maximum are selectable) and press Graph.
Results are displayed in a graph format.
7. To print detailed test statistics for several periods, proceed as follows:
a. Select the periods in the detailed test statistics table and press Data Print/Send to Host from
the generic toolbar.
A dialog box asks for user confirmation.
b. Press OK to validate or Cancel to cancel.
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For detailed information concerning detailed test statistics interpretation, refer to the Test
Counter (On Request) > Detailed Test Statistics Interpretation chapter.
■ Test Statistics Interpretation, p.94
■ Detailed Test Statistics Interpretation, p.97
6.4. Detailed Test Statistics Interpretation
For detailed information concerning the procedure to check test statistics, refer to the Test
Counter (On Request) > To Check Detailed Test Statistics for One Application chapter.
Detailed test statistics table

The detailed test statistics table displays detailed statistics of tests performed on the instrument
during the defined period for one application. Results are sorted by period.
Heading Description
Selection To select or to deselect a period.
If selected, the tests for this period are taken into account in the cumulative
test statistics table.
Time Period Period
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Heading Description
deleted) columns.
Cumulative test statistics table

The cumulative test statistics table displays statistics of all tests for the periods selected in the
detailed test statistics table (Total selected line) and for all the periods (Total all line).
Heading Description
deleted) columns.
Graph
The graph displays detailed test statistics for the periods selected in the detailed test statistics table.
The graph displays the following data:

■ X-axis: period,
■ Y-axis: number of tests performed,
■ Green line: number of control tests,
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■ Yellow line: number of calibration tests,

■ Black line: number of patient tests,
■ Red line: total number of patient, calibration and control tests.
■ To Check Detailed Test Statistics for One Application, p.95
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100 User Manual

Workflow
1. Sample Materials................................................................................................................ 102

1.1. Sample Type and Volume.......................................................................................................... 102
1.2. Tubes Labelling Best Practices..................................................................................................102
2. Workflow Overview............................................................................................................ 104
3. Start of Day........................................................................................................................... 105

3.1. To Check the Instrument............................................................................................................105
3.2. To Switch the Printer On............................................................................................................ 106
3.3. Starting the Instrument.............................................................................................................. 107
3.4. To Perform ISE Module Activation (Option)............................................................................... 110
4. Reagent Status.................................................................................................................... 111

4.1. Reagent Tray Description...........................................................................................................111
4.2. To Check Reagent Status.......................................................................................................... 112
5. Calibration and Control.................................................................................................... 114

5.1. ISE Calibration (Option)..............................................................................................................114
5.2. Calibration and Control Worklists.............................................................................................. 117
5.3. To Load Calibrators and Controls on the Analyser....................................................................123
5.4. Work Balance.............................................................................................................................124
5.5. To Start Analyses....................................................................................................................... 129
5.6. Test Review................................................................................................................................130
5.7. Calibration and Control Results Validation................................................................................ 138
6. Patient Samples.................................................................................................................. 158

6.1. Patient Worklist.......................................................................................................................... 158
6.2. To Load Patient Samples on the Analyser................................................................................. 169
6.3. Work Balance.............................................................................................................................170
6.4. To Start Analyses....................................................................................................................... 175
6.5. To Run Additional Patient Samples or a Stat Sample............................................................... 176
6.6. Sample Status............................................................................................................................178
6.7. Test Review................................................................................................................................180
6.8. Patient Results Validation.......................................................................................................... 188
6.9. Patient Results Archives............................................................................................................ 199
7. Common Tasks in a Working Day................................................................................206

7.1. Standby Mode............................................................................................................................206
7.2. To Change User......................................................................................................................... 208
7.3. To Create a New Worklist.......................................................................................................... 209
8. End of Day..............................................................................................................................212
8.1. To Check the Patient Worklist....................................................................................................212
8.2. To Check the Instrument............................................................................................................213
8.3. To Shut Down the Instrument.................................................................................................... 214
8.4. To Switch the Printer Off............................................................................................................216
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Sample Materials
1. Sample Materials
1.1. Sample Type and Volume
Samples such as serum, plasma, urine, cerebrospinal fluid (CSF), whole blood and homogeneous
liquid can be used on the Pentra C400.
Ensure that a sufficient sample volume without air bubbles or foam is placed in the
instrument, whatever the sample type (calibrator, control, patient sample).
Refer to each reagent notice to determine the sample volume required (refer to the Performance on
Pentra C400 > Sample Volume paragraph) and take into account the following dead volumes:
■ primary and secondary tubes: 1 mL,
■ sample cups: 100 µL.
For any further information or special care regarding samples such as pretreatment or sample
stability, please refer to the corresponding reagent notice.
1.2. Tubes Labelling Best Practices
Only one barcode label can be stuck on the tube.
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Sample Materials
Recommendations on Tubes Labelling

■ The length of the barcode symbol shall not exceed 50 mm including the required minimum quiet
zone of 5 mm at each end of the symbol.
■ The height of the barcode symbol on the collection tube shall not be less than 10 mm.
■ The total size of the label may be more than 10 by 50 mm to allow for human readable information
to be printed.
■ The label shall be placed with the bars perpendicular to the axis of the tube. The label skew shall
be less than ± 5° with respect to the axis of the sample container.
■ Instrument readers shall accommodate a barcode symbol including quiet zone placed within a
zone of 16 to 68 mm from rim of sample container. The label shall be applied to the cylindrical
portion of the tube below the rim, skirt, or cap of the sample container.
Recommendations on Printing the Barcode Labels
Misprinted patient identification barcodes or barcodes with bad interpretation may

generate incorrect patient identification numbers.
Caution About Partial Scans using Interleaved 2 of 5 encoded identification: It should

be noted that where variable length ITF symbols are used without a check digit, there is a
danger of the scanner misinterpreting a partially scanned code as a complete code. We
suggest that Interleaved 2-of-5 always be used with the Check Digit option enabled or
that you standardize on a single character length of Interleaved 2-of-5 barcodes.
The size of a barcode varies within certain limits depending on print conditions. The width of the
symbol must be selected so that each bar corresponds to the entire number of the printer dots except
when the width of the barcode bars varies within +/- 1 printer dot and especially for low printing
resolution with larger size dots. The margins on the left and right sides of the barcode must always be
proportional to the width of the symbol. Therefore, ensuring high quality of each barcode as well as
accuracy and correct data structure.
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Workflow Overview
2. Workflow Overview
Start of day
Check the instrument

- Distilled water level
- Waste level
- "New cuvette" holder
- "Used cuvette" holder
- Levels of ISE reagents (option)
Switch the printer on
Start the instrument
Perform ISE module activation (option)
Check reagent status
Check ISE module status (option)
Run calibrations and controls
Check calibration and control results
Run patient samples
Check patient results
End of day
Check the patient worklist
Check the instrument

- Distilled water level
- Waste level
- "New cuvette" holder
- "Used cuvette" holder
- Levels of ISE reagents (option)
Shut down the instrument
- Clean ISE module with Etching (option)
- Clean needles with Deproteinizer
Switch the printer off
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Start of Day
3. Start of Day
3.1. To Check the Instrument
At the beginning of each day (before startup) or at the end of each day (before shutdown),
check the following items:
■ distilled water level,
■ waste level,
■ "new cuvette" holder,
■ "used cuvette" holder,
■ levels of ISE reagents.
1. Check the distilled water level in the tank. Fill the tank if necessary.
2. Check the waste level in the tank. Empty the tank if necessary.
protection, etc.). Follow your local and/or national guidelines for biohazard waste
disposal.
■ At the beginning of each day, before startup, check if the waste container needs to
be emptied.
circumstance.
3. Check the "new cuvette" holder.

4. If it needs to be filled, add cuvette segments as follows:
a. Take a new rack of cuvette segments (Cuvette Segments A11A01891).
b. Remove the plastic cover from the rack.
c. Place the open end of the rack against the "new cuvette" holder and push the cuvette
segments into the holder.
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Start of Day
■ Do not wash and re-use cuvettes. They are designed for single use only.
■ Cuvette segments with at least one used cuvette must never be loaded in the
reaction tray.
5. Check the "used cuvette" holder.

6. If it needs to be emptied, discard the cuvette segments as follows:
a. Press the clip and pull out the "used cuvette" holder.
b. Discard the cuvette segments and reinstall the holder.
Dispose of used cuvettes according to your local and/or national guidelines for
biohazard waste disposal.
7. For Pentra C400 with ISE module (option), open the ISE module cover to check levels of ISE
reagents.
8. If an ISE reagent needs to be replaced, refer to the Maintenance and Troubleshooting >
Maintenance > Other Procedures > To Replace ISE Reagents (Option) chapter.
■ ISE reagents running dry can damage the electrodes.

Ensure that there is always enough ISE reagents to perform the ISE module
calibrations.
■ To minimize environmental interferences, the ISE module cover must always be
■ To Replace ISE Reagents (Option), p.363
3.2. To Switch the Printer On
Start and check the printer at the beginning of the day.
1. Check if the printer has enough paper for daily operations. If not, add some paper following the
instructions of the printer user guide.
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Start of Day
2. Press the ON/OFF switch.

3. Wait during printer initialization.
4. Make sure the control LEDs are on.
If the printer does not work properly, refer to its user guide.
3.3. Starting the Instrument
The Pentra C400 hardware has to remain on 24 hours a day. This is necessary to keep the cooling
unit functional and therefore maintain the temperature in the refrigerated area of the reagent tray. Only
the Pentra C400 software must be started, at the beginning of the day, either manually or
automatically if automatic startup is programmed.
3.3.1. To Start the Instrument
Follow this procedure to start the instrument at the beginning of the day, either manually
or automatically if automatic startup is programmed.
The Pentra C400 hardware has to remain on at the instrument shutdown.

The following items must be checked before startup:
■ waste level,
1. If the automatic startup is programmed, the instrument is automatically started every day at the
time specified.
2. If not, press the button located on the right side of the instrument for a few seconds.
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Start of Day
The Pentra C400 software is started after a few seconds:

■ the computer and the spectrophotometer lamp are switched on,
■ temperature regulation of the reaction tray and the reagent needle,
■ computer boot,
■ operating system and Pentra C400 software launch.
If not, make sure that the main switch at the back of the analyzer is on (I).
3. Wait for the end of Pentra C400 software startup.
The Startup window is displayed and the instrument initialization is performed:
■ databases check and compacting,
■ computer/instrument synchronisation,
■ mechanical initialization,
■ barcodes reading on reagent and sample trays,
■ spectrophotometer gain adjustment and check,
■ lamp stability on air,
■ reference intensity (I0) on water,
■ reaction tray check (used cuvette segments are unloaded from the reaction tray and new
cuvette segments are loaded),
■ temperature check.
4. Wait for the end of instrument initialization.
The Startup window becomes accessible.
You can now log in to the application.
■ To Check the Instrument, p.105
■ To Configure the Automatic Startup, p.305
■ To Log in to the Application, p.108
3.3.2. To Log in to the Application
Follow this procedure to log in to the application with your user name and password.
■ The Startup window must be accessible.

■ Your user account has previously been created.
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Start of Day
1 = Name dropdown list

2 = Password field
3 = New Worklist option
4 = OK
1. Select your user name or login from the Name dropdown list.
2. Type your password in the Password field.
3. The New Worklist option is selected by default.
This option allows you to begin a new day of work. This means that a new worklist is created and
the previous worklist is archived.
Samples of the previous worklist are either deleted if they are ordered or pending, or archived if
they are incomplete, for validation or validated.
Sample identifiers (sample ID or rack position, depending on sample identification mode) are
cleared for the new worklist.
Patient ID are not cleared for the new worklist.
4. Press OK to validate and to enter the application.
The main menu is displayed.
■ To Start the Instrument, p.107
■ To Create a User Account, p.332
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Start of Day
3.4. To Perform ISE Module Activation (Option)
Follow this procedure to perform an ISE module activation at the beginning of the day
before running samples or during the day of work after an ISE module cleaning.
Access: Main menu > Services > Customer Services > ISE
The ISE module should not be busy.
The ISE module activation consists in running a serum or plasma sample in order to condition the
electrodes before running samples.
1 = Rack dropdown list

2 = Pos. dropdown list
3 = ISE activation
1. Select an available rack position on the sample tray from the Rack and Pos. dropdown lists.
2. Press ISE activation.
A dialog box asks you to place the activator at the selected rack position.
3. Place a serum or plasma sample on the sample tray at the selected rack position.
4. Press OK.
The activator is pipetted and dispensed into the ISE module sample cup. At the end, a dialog box
asks you to remove the activator from the selected rack position.
5. Remove the activator from the sample tray.
6. Press OK.
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Reagent Status
4. Reagent Status
4.1. Reagent Tray Description
The reagent tray is symbolized in the middle of the main menu. It allows you to visualize solutions
configured on the tray and to access their details.
The instrument checks the solutions on board (barcodes reading) during the initialization
and when closing the reagent tray cover.
The colored circle around the reagent tray indicates if the reagent tray is accessible or in progress.
■ Green when the reagent tray is accessible (solutions can be loaded/unloaded).
■ Blue when the reagent tray cover is locked.
The reagent tray contains 52 positions including 44 refrigerated at 4°C - 10°C (39°F - 50°F) and eight
positions at room temperature. The reagent tray can hold reagent cassettes, reagent racks and
calibrator/control reagent racks.
The status of each solution is indicated by a color code to which a legend is available by pressing the
blue background outside the reagent tray.
Color code Legend Description

OK ■ Cassette: The cassette is available for analysis with
sufficient volume.
■ Reagent rack: A solution is configured on this rack
sector.
Reserve backup Back-up cassette (only for cassette)
Low Volume There is less than 10% of the initial volume remaining
(only for cassettes).
To be checked The solution needs to be checked because of one of the
following reasons:
■ The cassette is empty.
■ The solution is unknown (bad barcode for example).
■ Not enough solution for the pending analyses.
■ The solution is inactive.
■ The solution has reached its use limit date or has
expired.
Available Empty position
Control Control reagent rack
Calibrator Calibrator reagent rack
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Reagent Status
You can access the solution details by pressing a position on the reagent tray. The information below
is displayed depending on whether the solution is in a cassette, in an open cassette, on a reagent
rack or on a calibrator/control reagent rack.
Cassette
Heading Description
Solution Name Solution short name
Position Position number on the reagent tray
Tests Available Number of tests that can be performed with the solution volume remaining
in the cassette.
Tests to be done Number of tests to be performed on the samples present in the instrument.
Expiry Date Expiration date before opening.
Open cassette
Heading Description
Reagent rack
Heading Description
Reagent Rack Rack ID
Tray Position First position number on the reagent tray
Position Rack sector: A, B or C
Tests to be done Number of tests to be performed on the samples present in the instrument.
Calibrator/control reagent rack
Heading Description
Reagent Rack Rack ID
Name Calibrator/control name
Lot Number Calibrator/control lot number
Expiry Date Calibrator/control expiration date
4.2. To Check Reagent Status
Follow this procedure to check the status of each solution configured on the reagent tray.
The main menu must be displayed.
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Reagent Status
1 = Reagent tray
2 = Solution requiring an additional check
1. Check the status of each solution configured on the reagent tray from the main menu.
The status of each solution is indicated by a color code on the reagent tray. The solutions
appearing in red require an additional check.
2. Physically check the solutions in red and replace them if necessary.
The colored circle around the reagent tray on the main menu must be green. This
means that the reagent tray is accessible.
When you use reagent racks or calibrator/control reagent racks, you must ensure that a
sufficient solution volume without air bubbles or foam is placed in the instrument.
■ Reagent Tray Description, p.111
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Calibration and Control
5. Calibration and Control
Every day before running samples, you have to perform a new calibration for the tests that require one
and you have to check all of your tests with the appropriate control materials.
The ISE module remains on 24 hours a day and is calibrated regularly. At the beginning of each day
before running samples, you have to check the ISE module status.
5.1. ISE Calibration (Option)
■ Check the ISE module status.

■ Run an ISE calibration when necessary.
5.1.1. To Check ISE Module Status
Follow this procedure to check the ISE module status.
1. Check the ISE module status from the main menu.

Button Legend Description
The ISE module is disabled.
To enable the ISE module, refer to the Settings > System
Unavailable
Configuration > Analyser > ISE Module Configuration
(Option) > To Enable or To Disable ISE Module chapter.
Red Indicates an error on the ISE module.
Blue with a red

Indicates an error on the ISE calibration.
circle
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The ISE module is busy (performing an ISE calibration for

Blue example).
Wait until the ISE module is ready.
Blue with a green

The ISE module is ready.
circle
2. In case of error on the ISE module, perform a global initialization of the ISE module as follows:
a. Enter Main menu > Services > Customer Services > ISE.
b. Press Global Initialization.
A global initialization of the ISE module is performed. It takes a few minutes.
If the error persists, refer to the Maintenance and Troubleshooting > Troubleshooting > ISE Module
(Option) chapter.
3. In case of error on the ISE calibration, run a new ISE calibration.
Refer to the ISE Calibration (Option) > To Run an ISE Calibration chapter.
■ To Enable or Disable ISE Module, p.308
■ To Run an ISE Calibration, p.115
■ ISE Module (Option), p.386
5.1.2. To Run an ISE Calibration
Follow this procedure to run a 2-point calibration in case of error on the ISE calibration.
■ The main menu must be displayed.

■ The ISE module should not be busy.
1. Press the ISE Module Status button.

The ISE calibration results screen is displayed.
2. Check the ISE calibration results.
For detailed information concerning ISE calibration results interpretation, refer to the
ISE Calibration (Option) > ISE Calibration Results chapter.
3. Press Calibrate.
The 2-point calibration is performed. It takes a few minutes.
4. Wait for the end of the 2-point calibration.
The new ISE calibration results are displayed.
5. Make sure that no ISE analytical flag has been triggered in 1 Point Cal Error and 2 Point Cal
Error fields.
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6. If an error persists on the ISE calibration, refer to the Maintenance and Troubleshooting >
Troubleshooting > ISE Module (Option) > Error on the ISE Calibration chapter.
■ Error on the ISE Calibration, p.388
■ ISE Calibration Results, p.116
5.1.3. ISE Calibration Results
Access: Main menu > ISE Module Status
The ISE calibration results screen displays the date and time of the last ISE calibration (at the top of
the screen) as well as the last ISE calibration results for each electrode.
Heading Description
Slope Slope (A) of the regression line y = A * x + B
Intercept Intercept (B) of the regression line y = A * x + B
1 Point Cal Error ISE analytical flag on the low standard value.
mV(1) Low standard value in mV.
2 Point Cal Error ISE analytical flag on the high standard value.
mV(2) High standard value in mV.
For detailed information concerning ISE analytical flags, refer to the Alarms > Analytical
and Quality Flags > ISE Analytical Flags chapter.
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The expected values of the slope and the sensitivity (difference between the low and high standard
values) for each electrode are given in the following table:
Electrode Slope normal range (mV/dec) Sensitivity normal range (mV)

Chloride -53.0 to -28.0 5.0 - 9.4
Potassium 37.0 to 67.0 9.0 - 16.3
Sodium 38.0 to 65.0 8.5 - 14.4
■ ISE Analytical Flags (Option), p.445
5.2. Calibration and Control Worklists
5.2.1. Calibration Worklist Overview
Access: Main menu > Worklist > Calibration
The calibration worklist lists all calibration requests that are ordered, pending or incomplete. As soon
as samplings of an incomplete calibration are finished, the request is deleted from the worklist. It is
then transferred to the result list.
Calibration requests are sorted by date and are listed in a table format which gives the following
information.
Heading Description
Status Calibration status: Ordered, Pending or Incomplete
Test Application local code for the test to be calibrated
Position Rack position of calibrator
Name Calibrator name
Lot Calibrator lot number
Order Date Request date
The Calibration tab allows you to add and to delete calibration requests.
■ To Add Calibration Requests, p.118
■ To Delete Calibration Requests, p.119
5.2.2. Adding Calibration Requests
5.2.2.1. Tests Selection in the Request Capture Screen
Display Meaning Implications

The test is not requested and the The test can be requested.
corresponding reagent is active.
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The test is not requested and the The test cannot be requested (except from
corresponding reagent is inactive. the host).
The test is requested but it is not in The test can be canceled.

progress. The number of replicates is modifiable.
The test is requested and it is in The test cannot be canceled.

progress. The number of replicates can be increased
but it cannot be decreased.
The test cannot be requested again until
the previous result is validated.
The test is requested but the The test cannot be canceled.

corresponding reagent is inactive. The number of replicates cannot be
modified.
5.2.2.2. To Add Calibration Requests
Follow this procedure to order calibrations.
1. Press Add new.

The request capture screen is displayed.
1 = All parameters option

2 = All calibrations expired only option
3 = All calibrations expired in window option
4 = Tests selection
5 = OK
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2. Select the tests to be displayed from the following options.

■ All parameters: To display all tests that can be calibrated.
■ All calibrations expired only: To display the tests for which the calibration has expired.
■ All calibrations expired in window: To display the tests for which the calibration will expire in
a programmed time lapse.
The time lapse must be previously programmed in Main menu > Services >
System Configuration > Analyser.
3. If the All calibrations expired only or All calibrations expired in window option is chosen, the
tests that require a new calibration are selected by default. You can deselect the tests that you do
not wish to calibrate.
4. If the All parameters option is chosen, select the tests that you want to calibrate.
For detailed information concerning tests selection, refer to the Adding Calibration
Requests > Tests Selection in the Request Capture Screen chapter.
Calibration requests are added in the worklist.
■ For tests using the Factor calibration mode, a reagent blank is carried out.
For tests using the other calibration modes, a reagent blank is performed with the
calibration if configured in the application.
■ If, for a test, the Control required option is selected in the application and the
required default controls are configured, then the default controls are automatically
performed with the calibration.
■ To Program the Time Lapse for Displaying Calibrations that Will Expire, p.310
■ Tests Selection in the Request Capture Screen, p.117
5.2.3. To Delete Calibration Requests
Follow this procedure to delete calibration requests from the worklist.
1. Select the calibration request and press Delete.

The calibration request must be ordered or pending but not incomplete.
2. Press OK to validate or Cancel to cancel.
3. Repeat steps 1 and 2 for each calibration request that you want to delete.
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5.2.4. Control Worklist Overview
Access: Main menu > Worklist > Control
The control worklist lists all control requests that are ordered, pending or incomplete. As soon as
samplings of an incomplete control are finished, the request is deleted from the worklist. It is then
transferred to the result list.
Control requests are sorted by date and are listed in a table format which gives the following
information.
Heading Description
Status Control status: Ordered, Pending or Incomplete
Test Application local code for the test to be controlled
Position Rack position of control
Name Control name
The Control tab allows you to add and to delete control requests.
■ Adding Control Requests, p.120
■ To Delete Control Requests, p.123
5.2.5. Adding Control Requests




modified.
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5.2.5.2. To Add Default Control Requests
Follow this procedure to order default controls.
If, for a test, the Control required option is selected in the application and the required
default controls are configured, then the default controls are automatically performed with
the calibration.
1. Press Add new.

1 = Default Control option

2 = Tests selection
3 = OK
2. Select the Default Control option to display the tests for which default controls are configured.
Up to three default controls can be configured for a test on condition that the default controls are
required in the application.
3. Select the tests that you want to control.
■
Press Select all to select all the tests or Erase to deselect all the
tests.
■ For detailed information concerning tests selection, refer to the Adding Control
Default control requests are added in the worklist.
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If several default controls are configured for a test, then a control request is created for
each default control.
5.2.5.3. To Add Control Requests Selecting the Control
Follow this procedure to order controls.
1. Press Add new.

1 = Control Selection area

2 = Tests selection
3 = OK
2. Select a control from the Control Selection area.
Press Down to display the next controls.
The control name, the rack position of control, the control lot number and expiration date are
displayed.
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3. Select the tests that you want to control.
■
Press Select all to select all the tests or Erase to deselect all the
tests.
■ For detailed information concerning tests selection, refer to the Adding Control
4. For each selected test, configure the number of replicates (from 1 to 20 replicates) as follows:
a. Select the test.
b. Press the up or down arrows (right side of the screen) to increase or to decrease the
number of replicates.
The number of replicates is set to 1 by default.
Control requests are added in the worklist.
5.2.6. To Delete Control Requests
Follow this procedure to delete control requests from the worklist.
1. Select the control request and press Delete.

The control request must be ordered or pending but not incomplete.
3. Repeat steps 1 and 2 for each control request that you want to delete.
5.3. To Load Calibrators and Controls on the Analyser
Follow this procedure to place calibrators and controls on the sample tray and/or on the
reagent tray.
Access: Main menu > Worklist
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1. Press the Calibration tab to view the calibration worklist.
1 = Configured positions
2. Place the required calibrators on racks according to the configured positions.
3. Press the Control tab to view the control worklist.
4. Place the required controls on racks according to the configured positions.
5. Load the racks on the sample tray and/or on the reagent tray.
■ Before loading racks on the sample tray, ensure that the sample tray LED is green.
If not, press Pause to stop samplings on the sample tray and wait for the LED to
turn green.
■ If automatic reruns must be performed, the instrument turns to "Sampling" status
and the LED turns to orange for a few seconds before turning red. Never load
racks on the sample tray when the LED is orange or red.
Before loading racks on the reagent tray, make sure that the colored circle around the
reagent tray on the main menu is green. This means that the reagent tray is accessible.
■ Sample Type and Volume, p.102
5.4. Work Balance
The Work Balance menu allows you to assess the reagents on board relative to the analyses to be
performed.
This menu is divided into two tabs:
■ Reagent supply
■ Sampling Exception
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5.4.1. Reagent supply
Access: Main menu > Work Balance > Reagent supply
The Reagent supply tab lists the solutions necessary for the pending tests.
You can display either the pending tests for the samples present on the instrument or those for the
samples programmed in the worklist.
■ Tubes on tray: To display the pending tests for the samples present on the instrument.
■ Worklist: To display the pending tests for the samples programmed in the worklist.
ISE tests are not taken into account.
The solutions are associated with a color code:

■ Green when the solution volume remaining in the cassette is sufficient for the pending tests.
■ Red when the solution will be missing.
■ Black when the solution is not provided in a cassette. The work balance is then not effective.
The solutions are listed in a table format which gives the following information.
Heading Description
Solution requested Solution short name
Capacity requested ■ Cassette: Number of tests to be performed.
■ Open cassette or reagent rack: Solution volume necessary for the tests
to be performed (without taking into account the dead volume).
Present on reagent tray ■ Reagent: Number of tests that can be performed with the solution
volume remaining in the cassette.
■ Diluent or cleaner: Solution volume remaining in the cassette.
Only for cassette.
Lot # Solution lot number
Position ■ Cassette or open cassette: Position number on the reagent tray.
■ Reagent rack: First position number on the reagent tray + rack sector.
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Heading Description
Status Solution status: Active or Inactive
On tray If selected, the solution is present on the reagent tray.
The Host request button allows you to manually ask the host if there are
additional tests programmed for a validated patient sample. This function is available only
if the Sending validated samples option is enabled in Main menu > Services > System
Configuration > Host Connection.
■ To Configure the Host Connection, p.319
5.4.2. Sampling Exception
Access: Main menu > Work Balance > Sampling Exception
The Sampling Exception tab displays the pending tests for which a sampling alarm will be triggered.
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The tests are listed in a table format which gives the following information:
Heading Description
Sample ID ■ Blank: "BLANK" on yellow background.
■ Calibration: Calibrator name on yellow background.
■ Control: Control name on green background.
■ Patient sample: Sample ID.
Position Rack position of the sample tube
Test Application local code for the test
Sampling Alarms Sampling alarm
To display additional information concerning the sampling alarm.
Sampling Alarm Date Sampling alarm date and time
5.4.3. To Anticipate Reagent Shortage and Sampling Alarms
Follow this procedure to assess the reagents on board relative to the analyses to be
performed.
The instrument checks the solutions on board (barcodes reading) on reagent and sample trays. It
takes a few minutes.
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1 = Tubes on tray option

2 = Worklist option
1. Select either Tubes on tray or Worklist option.

The solutions appearing in red will be missing.
2. Physically check the solutions in red and replace them if necessary. Physically check the solutions
in black and if necessary refill them with the requested volume (do not forget to add the dead
volume). Solutions in green do not require an additional check.
3. Press the Sampling Exception tab.

The Sampling Exception tab displays the pending tests for which a sampling alarm will be
triggered.
4. Check the expected sampling alarms.
Refer to the Alarms > Sampling Alarms chapter.
■ Reagent supply, p.125
■ Sampling Exception, p.126
■ Sampling Alarms, p.420
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5.5. To Start Analyses
Follow this procedure to a run patient sample, calibration or control.
Before running samples, the following conditions must be fulfilled:

■ The instrument must be in the "Ready" status.
■ The following items must have been checked:
■ waste level,
■ The mixer must be in place.
■ Covers must be closed.
1. Press Start.
Before performing the analyses, the reagent tray temperature is checked and if it is out of range, a
dialog box is displayed: The current reagent tray temperature [temperature] is out of the range
(acceptable range). The results can be affected by this malfunction. We recommend you to perform
controls. Do you still want to run analysis?
This message means that the reagents refrigeration does not work properly and this
can generate erroneous test results.
■ Press Cancel to cancel the analyses without any warning. This will allow you to perform the
appropriate controls before performing the analyses.
■ Press OK to perform the analyses in spite of this message. The analyses are performed and
the warning #642 Worklist performed with reagent tray temperature [temperature] out of the
range (acceptable range) is triggered.
The instrument turns to the "Sampling" status, then to the "Analysing" status.
1 = Instrument status
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2. Wait for the end of analyses.

The instrument turns to the "Ready" status.
5.6. Test Review
The Test Review menu allows you to review the tests in progress, to check sampling alarms and
analytical flags that may have been triggered and to manually export results to a USB key at each end
of run.
This menu is divided into four tabs:
■ Test Result
■ Error Report
■ Sequencing
5.6.1. Test Result
Access: Main menu > Test Review > Test Result
The Test Result tab displays the tests in progress as soon as they are pipetted.
The tests are sorted by run date.
■ Up to 200 items are displayed from the oldest to the most recent. Beyond this number,
the oldest are deleted.
■ The tab is cleared at instrument startup, when starting analyses and when a new
worklist is created.
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Heading Description
Status Ordered, Pending, Incomplete, For validation or Validated
For Ordered and Pending status, at least one test of the sample is finished.
Result(s) ■ Blank and Calibration: Absorbance value.
■ Control: Final result. On red background if out of confidence range.
■ Patient sample: Final result.
"--.-----" means that the result is not given because of a sampling alarm or
an analytical flag.
QF Quality flag (only the flag having the highest priority is displayed).
D/C The sample was automatically rerun with post-dilution (Dil) or post-
concentration (Conc).
Only for patient sample.
Analysis flag Sampling alarm or analytical flag (only the flag having the highest priority is
displayed).
If both are triggered, only the sampling alarm is displayed.
Dec. Decision:
■ Blank: Accept or Delete.
■ Calibration: Not displayed.
■ Control: Accept or Delete.
■ Patient sample: Accept, Rerun, Modify or Delete.
Run date Sample run date and time
You can access the sample details by selecting a test and pressing Details.
You can also search for a sample either by sample ID or by position using the search tools at the
bottom of the screen.
The Export button allows you to manually export results to a USB key. Refer to
the Test Review > To Manually Export Results to a USB Key chapter.
■ To Manually Export Results to a USB Key, p.137
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Access: Main menu > Test Review > Sampling Exception
The Sampling Exception tab displays the tests for which a sampling alarm is triggered.
The tab is cleared at instrument startup and when starting analyses.
Heading Description
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5.6.3. Error Report
Access: Main menu > Test Review > Error Report
The Error Report tab displays the tests for which an analytical flag or a quality flag blocking the
automatic validation is triggered.
An item is deleted as soon as a decision on the test is made.
Heading Description
an analytical flag.
Analysis flag Analytical flag (only the flag having the highest priority is displayed).
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5.6.4. Sequencing
Access: Main menu > Test Review > Sequencing

■ every mixing,
Events are listed in table formats which are described below.

Reagent Arm
Heading Description
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Heading Description
Sample Arm
Heading Description
volume
on the rack,
Other
Heading Description
number on the tray
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5.6.5. To Check Sampling Alarms and Analytical Flags
Follow this procedure to check sampling alarms and analytical flags that may have been
triggered.
The Test Review button becomes red when a sampling alarm or an analytical flag is triggered.
1. Check the tests for which a sampling alarm is triggered.

2. Press the Error Report tab.
3. Check the tests for which an analytical flag is triggered.
Refer to the Alarms > Analytical and Quality Flags chapter.
■ Error Report, p.133
■ Analytical and Quality Flags, p.423
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5.6.6. To Manually Export Results to a USB Key
Follow this procedure to manually export results to a USB key at the end of run.
■ The Test Result tab should not be empty.

■ The instrument must be in the "Ready" or the "Emergency Stop" status.
Results are automatically exported to a USB key at each end of run if the Activate export
of the results on USB key option is selected in Main menu > Services > System
Configuration > Analyser. Refer to the Settings > System Configuration > Analyser > To
Enable or To Disable Automatic Export of Results chapter.
instrument.
2. Press the Export button:
All the completed test results are saved in a .csv file located in a folder named "Export" on the USB
key. ISE test results and ratio results are not exported.
.csv file example
■ To Enable or To Disable Automatic Export of Results, p.310
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5.7. Calibration and Control Results Validation
5.7.1. Calibration Results
Access: Main menu > Result Validation > Calibration
The calibration result list displays all calibration results that are incomplete, for validation or validated.
You can select the calibration results to be displayed from the following options.
■ For validation: To display the calibration results that are incomplete or for validation.
■ Current: To display the calibration results that are validated.
■ All: To display all calibration results.
Calibration results are listed in a table format which gives the following information.
Heading Description
Status Calibration status: Incomplete, For validation or Validated
Test Application local code for the calibrated test
Position ■ Blank: Reagent position
■ Calibration: Rack position of calibrator
Name ■ Blank: "BLANK"
■ Calibration: Calibrator name
Lot ■ Blank: Reagent lot number
■ Calibration: Calibrator lot number
Flag Calibration analytical flag.
Run Date Date and time of calibration run
■ For tests using the Factor calibration mode, a reagent blank is carried out.
■ An item in red means that the calibration is flagged with a calibration analytical flag or
a quality flag blocking the automatic validation.
The Calibration tab allows you to validate, to rerun or to delete a calibration or a reagent blank.
5.7.1.1. Calibration Results Interpretation
For detailed information concerning the procedure to check calibration results, refer to the
Calibration Results > To Validate a Calibration chapter.
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Calibration results
The result validation screen displays the new calibration results as well as the current calibration
results (at the bottom of the screen).
New calibration results
Heading Description
Position Rack position of calibrator
Name Calibrator name
Lot Calibrator lot number
Calibration Flag Calibration analytical flag.
Displayed in red.
New Calibration Date Date and time of calibration run
New blank (ΔO.D.) Absorbance value of reagent blank (if configured in the application).
Displayed in red if flagged.
Target Target value for each calibrator level
Run1 Absorbance value of the first run for each calibrator level.
Run2 Absorbance value of the second run (if configured in the application) for
each calibrator level.
Run3 Absorbance value of the third run (if configured in the application) for each
calibrator level.
Dev_Rep Deviation concerning replicates in %.
Displayed in red if it exceeds the authorized value.
"--.--" means that the deviation cannot be calculated because only one run
is configured.
Dev_C Deviation to the curve in %.
Displayed in red if it exceeds the authorized value.
"--.--" means that the deviation cannot be calculated because only one
calibrator level is configured.
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■ If several runs are configured, you can deactivate a defective result by double-clicking
the result. The result is then displayed in gray and the calibration results are updated.
■ For detailed information concerning analytical flags or quality flags, refer to the Alarms
> Analytical and Quality Flags chapter.
Current calibration results
Heading Description
In Progress Calibration Date Date and time of calibration run
Previous blank (ΔO.D.) Absorbance value of reagent blank (if configured in the application).
Run1 Mean absorbance value for each calibrator level.
Calibration curves
You can display the calibration curves by selecting a result in the new calibration results table.
The graph (right side of the screen) displays the following data:
■ X-axis: concentration,
■ Y-axis: rate,
■ Green continuous line: new calibration curve,
■ Blue dotted line: current calibration curve.
■ The calibration curve points are displayed in green for the new calibration curve or in blue for the
current calibration curve. Click a point to display the point concentration and rate.
■ For linear calibration modes (Slope average, Linear regression), the calculated calibration factor is
displayed in green for the new calibration curve or in blue for the current calibration curve.
■ For the Linear regression calibration mode, the intercept (B) of the regression line y = A * x + B is
displayed in green for the new calibration curve or in blue for the current calibration curve.
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Kinetic curves per level

You can display the kinetic curves per level by selecting a column heading in the new calibration
results table.
■ X-axis: time,
■ Y-axis: absorbance value,
■ Purple line: kinetic curve of the first run,
■ Yellow line: kinetic curve of the second run,
■ Green line: kinetic curve of the third run.
Kinetic curves per run

You can display the kinetic curves per run by selecting a result in the new calibration results table and
pressing the OD tab.
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■ X-axis: time,
■ Green or blue lines: kinetic curves for each calibrator level as well as for the reagent blank (if
configured in the application).
■ If the absorbance deviation check on linear regression is configured in the application, the
correlation coefficient r2 is calculated and displayed for each calibrator level. Click a kinetic curve
to display the corresponding correlation coefficient r2.
Data of kinetic curves for each calibrator level as well as for the reagent blank (if configured in the
application) are also displayed in a table format (left side of the screen).
If analytical flags are triggered, they are displayed in a second table.
■ Calibration Parameters, p.260
■ Calculation Parameters, p.267
■ To Validate a Calibration, p.142
5.7.1.2. To Validate a Calibration
Follow this procedure to manually validate a calibration.
If the calibration automatic validation is configured in Main menu > Services > System
Configuration > Results validation, calibration results are automatically validated on condition that:
■ No point used for calculation is flagged (except with the analytical flag CALC_RANGE_HIGH /
LOW).
■ For each calibrator level, deviations (Dev_Rep and Dev_C) do not exceed the authorized values.
■ The calibration factor is not out of the programmed values.
■ The reagent blank (if configured in the application) is not flagged.
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1 = For validation option

2 = Calibration results selection
3 = Details
1. Select the For validation option to display the calibration results that are incomplete or for
validation.
2. Select the calibration results that you want to review and press Details.
This function is unavailable if the selected calibration is incomplete.
The result validation screen is displayed.
4 = Edit
5 = Accept
6 = OK
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3. Check the calibration results and make sure that no analytical flag or quality flag has been
triggered.
■ For detailed information concerning calibration results interpretation, refer to the

Calibration Results > Calibration Results Interpretation chapter.
■ In case an analytical flag or a quality flag has been triggered, do not validate the
calibration. Refer either to the Calibration Results > To Rerun a Calibration or a
Reagent Blank chapter to rerun the calibration or to the Calibration Results > To
Delete a Calibration or a Reagent Blank chapter to delete the calibration.
4. Press Edit.
5. Select Accept and press OK to validate.
■ When the calibration cannot be calculated, it cannot be validated and must be deleted. If
several runs are configured, you can deactivate a defective result in order to calculate the
calibration.
■ OK is unavailable if a default control for this test is in progress.
The new calibration becomes the current calibration.
■ To Configure Calibrations Automatic Validation, p.326
■ To Rerun a Calibration or a Reagent Blank, p.147
■ To Delete a Calibration or a Reagent Blank, p.148
■ Calibration Results Interpretation, p.138
5.7.1.3. Reagent Blank Results Interpretation

For detailed information concerning the procedure to check reagent blank results, refer to
the Calibration Results > To Validate a Reagent Blank chapter.
Reagent blank results
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Heading Description
Run Date Date and time of calibration run
Expiration date Reagent expiration date.
Only for cassette.
Position Reagent position
Lot Reagent lot number
Flag Calibration analytical flag.
Report Absorbance value of the new reagent blank
Previous Report Absorbance value of the previous reagent blank
For detailed information concerning analytical flags or quality flags, refer to the Alarms >
Analytical and Quality Flags chapter.
Kinetic curve
You can display the reagent blank kinetic curve by pressing the OD tab.
■ X-axis: time,
■ Green line: reagent blank kinetic curve.
Data of the reagent blank kinetic curve are also displayed in a table format (left side of the screen).
■ To Validate a Reagent Blank, p.145
5.7.1.4. To Validate a Reagent Blank
Follow this procedure to manually validate a reagent blank.
If calibrations automatic validation is configured in Main menu > Services > System Configuration >
Results validation, reagent blank results are automatically validated on condition that they are not
flagged.
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2 = Reagent blank results selection
3 = Details
validation.
2. Select the reagent blank results that you want to review and press Details.
This function is unavailable if the selected reagent blank is incomplete.
4 = Edit
5 = Accept
6 = OK
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3. Check the reagent blank results and make sure that no analytical flag or quality flag has been
triggered.
■ For detailed information concerning reagent blank results interpretation, refer to the
Calibration Results > Reagent Blank Results Interpretation chapter.
reagent blank. Refer either to the Calibration Results > To Rerun a Calibration or a
Reagent Blank chapter to rerun the reagent blank or to the Calibration Results > To
Delete a Calibration or a Reagent Blank chapter to delete the reagent blank.
4. Press Edit.
■ If the reagent blank is flagged with HIGH_ABS, it cannot be validated and must be deleted.
■ OK is unavailable if a default control for this test is in progress.
The new reagent blank becomes the current reagent blank.
■ To Configure Calibrations Automatic Validation, p.326
■ To Rerun a Calibration or a Reagent Blank, p.147
■ To Delete a Calibration or a Reagent Blank, p.148
■ Reagent Blank Results Interpretation, p.144
5.7.1.5. To Rerun a Calibration or a Reagent Blank
Follow this procedure to rerun a calibration or a reagent blank.
validation.
2. Select the calibration that you want to rerun and press Rerun:
This function is unavailable if the calibration is incomplete (unless it is flagged with a sampling
alarm) or validated.
A dialog box informs you that the calibration will be deleted and a new calibration will be ordered.
■ In case the calibration is deleted, the previous calibration will be the current calibration
and all following results are flagged with C (CAL_ERROR).
■ If default controls are required for this calibration, results are calculated using the
current calibration. If no current calibration exists, the default controls are deleted.
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5.7.1.6. To Delete a Calibration or a Reagent Blank
Follow this procedure to delete a calibration or a reagent blank.
validation.
2. Select the calibration that you want to delete and press Delete.
This function is unavailable if the calibration is incomplete or validated or if a default control for this
test is in progress.
■ In case the calibration is deleted, the previous calibration will be the current calibration
and all following results are flagged with C (CAL_ERROR).
■ If default controls are required for this calibration, results are calculated using the
current calibration. If no current calibration exists, the default controls are deleted.
5.7.1.7. To Print Calibration Results
Follow this procedure to manually print calibration results.
The calibration results must be previously validated.
Calibration results are automatically printed when validated if configured in Main menu > Services >
System Configuration > Printer.
1. Select the Current option to display the calibration results that are validated.
2. Select the calibration results that you want to print and press Data Print/Send to Host from the
generic toolbar.
3. Select the printout format from the following options:
■ standard,
■ detailed.
If reagent blank results are selected, the printout format is not selectable. The reagent
blank kinetic curve will be printed by default.
The selected calibration results are printed.
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Printout format: standard
Printout format: detailed
On the printouts, flagged results are indicated by an asterisk (*) in the column marked
F.
5. To print kinetic curves, proceed as follows:

a. Select the calibration results that you want to print and press Details.
b. Press the OD tab.
c. If several runs have been performed, select the run that you want to print from the Run spin
box.
d. Press Data Print/Send to Host from the generic toolbar.
e. Press OK to validate or Cancel to cancel.
■ To Configure Automatic Printouts, p.323
5.7.2. To Convert Current Calibration Results
Follow this procedure to modify some application parameters in order to convert the
current calibration results as well as the associated patient and control results.
The calibration results must be validated.
1. Select the Current option to display the calibration results that are validated.
2. Select the calibration results that you want to convert and press Details.
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3. Press the CONV button:
A screen divided into three tabs is displayed:

■ App. Param.
■ Calibration
■ Patients and Controls
4. Modify the application parameters from the App. Param. tab as follows:
a. Press Edit.
b. Change the application parameters where necessary.
Only the parameters below are modifiable:
■ Correlation, Linearity, Reference Range and Rerun Range areas in the General
Parameters tab.
■ The Calibration mode parameter and the Checks area in the Calibration Parameters tab.
■ All parameters in the Calculation Parameters tab.
For detailed information concerning absorbance applications parameters, refer to

the Absorbance Applications > Absorbance Applications Parameters chapter.
5. Once you modified the application parameters, press the Calibration tab to review the converted
calibration results.
6. Press the Patients and Controls tab to review the converted patient and control results.
■ Only the patient and control results that are for validation are displayed.
■ Ratio results and test results used in ratios are not displayed.
7. Modify some patient and control results by the converted results as follows:
a. Select a result.
b. Press OK.
c. Repeat steps a and b for each result.
The converted results are then flagged with R (CAL_CONV).
■ Absorbance Applications Parameters, p.253
5.7.3. Control Results
Access: Main menu > Result Validation > Control
The control result list displays all control results that are incomplete, for validation or validated.
Control results are sorted per control block. A control block contains either all the required default
controls for a test (up to three default controls can be configured for a test) or a single control if the
control is not configured as a default control for the test. Alternation of white and blue materializes the
separation between control blocks.
You can select the control results to be displayed from the following options.
■ Block for validation: To display the control results that are incomplete or for validation.
■ Current block: To display the control results that are validated.
Control results are listed in a table format which gives the following information.
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Heading Description
Status Control status: Incomplete, For validation or Validated
Name Control name
Run date Date and time of control run
Flag Sampling alarm or analytical flag (only the flag having the highest priority is
displayed).
An item in red means that the control is flagged with an analytical flag or a quality flag
blocking the automatic validation.
The Control tab allows you to validate, to rerun or to delete a control.
5.7.3.1. Control Results Interpretation
For detailed information concerning the procedure to check control results, refer to the
Control Results > To Validate a Control chapter.
Control results
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Heading Description
Name Control name
Report Final result. On red background if out of confidence range.
an analytical flag.
Flag Sampling alarm or analytical flag (only the flag having the highest priority is
displayed).
Quality flag Quality flag (only the flag having the highest priority is displayed).
Decision Accept or Delete
Kinetic curve
You can display the control kinetic curve by pressing the OD tab.
■ X-axis: time,
■ Green line: control kinetic curve.
correlation coefficient r2 is calculated and displayed.
Data of the control kinetic curve are also displayed in a table format (left side of the screen).
■ Calculation Parameters, p.267
■ To Validate a Control, p.152
5.7.3.2. To Validate a Control
Follow this procedure to manually validate a control.
If controls automatic validation is configured in Main menu > Services > System Configuration >
Results validation, control results are automatically validated on condition that they are not flagged
(except with the analytical flag CONF_RANGE_HIGH_W / LOW_W).
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1 = Block for validation option

2 = Control results selection
3 = Details
1. Select the Block for validation option to display the control results that are incomplete or for
validation.
2. Select the control results that you want to review and press Details.
This function is unavailable if the selected control is incomplete or, for a control block, if at least
one default control of the selected block is incomplete.
4 = Edit
5 = Accept
6 = OK
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3. Check the control results and make sure that no analytical flag or quality flag has been triggered.
■ For detailed information concerning control results interpretation, refer to the

Control Results > Control Results Interpretation chapter.
control. Refer either to the Control Results > To Rerun a Control chapter to rerun
the control or to the Control Results > To Delete a Control chapter to delete the
control.
4. Press Edit.
When the control result cannot be calculated, it cannot be validated and must be deleted.
The new control is validated.
■ To Rerun a Control, p.154
■ To Delete a Control, p.155
■ Control Results Interpretation, p.151
5.7.3.3. To Rerun a Control
Follow this procedure to rerun a control.
validation.
2. Select the control that you want to rerun and press Rerun:
This function is unavailable if the control is incomplete or validated.

However, an incomplete control can be rerun if it is flagged with a sampling alarm or if the
instrument is in "Ready" or "Emergency Stop" status.
This function is also unavailable if several replicates were requested for the control.
A dialog box informs you that the control will be deleted and a new control will be ordered.
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5.7.3.4. To Delete a Control
Follow this procedure to delete a control.
validation.
2. Select the control that you want to delete and press Delete.
This function is unavailable if the control is incomplete or validated.
However, an incomplete control can be deleted if it is flagged with a sampling alarm or if the
instrument is in "Ready" or "Emergency Stop" status.
When you delete a control result, this one is excluded from the statistical analyses but it is
still present in the Quality Control.
5.7.3.5. To Print Control Results
Follow this procedure to manually print control results.
Control results are automatically printed when validated if configured in Main menu > Services >
validation or the Current block option to display the control results that are validated.
2. Select the control results that you want to print and press Data Print/Send to Host from the
generic toolbar.
■ condensed,
■ standard,
■ detailed.
The selected control results are printed.
Printout format: condensed
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5. To print the control kinetic curve, proceed as follows:
a. Select the control results that you want to print and press Details.
This function is unavailable if the selected control is incomplete or, for a control block, if at
least one default control of the selected block is incomplete.
b. Press the OD tab.
c. Press Data Print/Send to Host from the generic toolbar.
d. Press OK to validate or Cancel to cancel.
5.7.3.6. To Send Control Results to the Host
Follow this procedure to manually send control results to the host.
The control results must have been previously validated.
Control results are automatically sent by test when validated if configured in Main menu > Services >
System Configuration > Host Connection.
1. Select the Current block option to display the control results that are validated.
2. Select the control results that you want to send and press Data Print/Send to Host from the
generic toolbar.
3. Press Send.
The Send window is displayed.
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The selected control results are sent.
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Patient Samples
6. Patient Samples
6.1. Patient Worklist
Access: Main menu > Worklist > Patient
The patient worklist lists all patient sample requests that are ordered, pending or incomplete. As soon
as samplings of an incomplete patient sample are finished, the request is deleted from the worklist. It
is then transferred to the result list.
Patient sample requests are sorted by patient ID and by date. Alternation of white and blue
materializes the separation between patient ID.
Patient sample requests are listed in a table format which gives the following information.
Heading Description
Status Sample status: Ordered, Pending or Incomplete
Sample ID Sample ID
Patient ID Patient ID
Last Name Patient last name
First Name Patient first name
The Patient tab allows you to add, to modify and to delete patient sample requests.
■ Creating a Patient Worklist, p.161
■ To Modify a Patient Sample Request, p.168
■ To Delete Patient Sample Requests, p.169
6.1.1. Patient Identification
Patient demographic data is registered in patient files. Each patient file is identified by a unique
patient number named patient ID. This patient ID is either captured by the operator or automatically
assigned by the instrument: "AUTO_PIDXXXXXXXX".
■ If the operator enters a patient ID that already exists, the patient demographic data is
displayed.
■ At least one field of the patient demographic data must be captured so that the
instrument automatically assigns a patient ID.
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Patient Samples
The patient demographic data can be modified from the instrument only if it was manually entered
from the instrument. If it was programmed from the host, it must be modified from the host. When a
patient file is modified (either from the instrument or from the host), all validated and archived sample
ID for this patient are flagged with an asterisk.
6.1.2. Sample Identification
Patient sample requests are identified in the worklist by a unique sample number named sample ID.
This sample ID is either captured by the operator or automatically assigned by the instrument:
"AUTO_SIDXXXXXXXX".
If the operator enters a sample ID that already exists in the worklist, all information about
this sample ID is displayed.
As soon as the analysis process begins on a sample tube, the associated request is searched in the
worklist upon two criteria:
■ the sample ID (identification mode),
■ the rack position of the sample tube (position mode).
It is important to previously configure the sample identification mode according to your

laboratory working method. Refer to the Settings > System Configuration > Analyser > To
Configure Loading Mode chapter.
When the corresponding request is found, the instrument automatically performs the analyses
requested in the worklist. As soon as samplings are finished, the request is deleted from the worklist.
It is then transferred to the result list.
The association between a sample tube and a request can be done only on the two following
conditions.
■ The sample tube must be present on the instrument.
If a request exists in the worklist but the associated sample tube is not found on the instrument,
the sample tube and the request are unmatched and the request stays pending.
■ The request must exist in the worklist.
If a sample tube is read on the tray and no associated request is found in the worklist, the sample
tube is displayed as unknown:
Identification mode
The identification mode is recommended on the Pentra C400 as it ensures security and flexibility.
As soon as the instrument reads a sample tube barcode, the associated sample ID is searched in the
worklist.
For example, the read barcode is "123" and the sample ID "123" is found in the worklist. The sample
tube and the request are matched. The instrument fills in the rack position of sample tube in the
worklist.
The identification mode is made to use the sample ID, however it is possible to force a rack position
from the request capture screen (refer to the Patient Worklist > Creating a Patient Worklist > Patient
Sample Request Fields chapter). In that case, the following cases can occur.
1. For example, the rack position "01.01" is forced in the worklist and a tube without barcode is
found on this position. The sample tube and the request are matched.
2. The rack position "01.01" is forced in the worklist and a tube with barcode is found on this
position.
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Patient Samples
a. The sample ID was not entered by the operator, it is then filled in by the instrument. The
sample ID is identical to the read barcode. The sample tube and the request are matched.
b. The sample ID was not entered by the operator, it is then filled in by the instrument. The
sample ID is different from the read barcode. The sample tube and the request are
mismatched.
c. The sample ID was entered by the operator and it is identical to the read barcode. The sample
tube and the request are matched.
d. The sample ID was entered by the operator and it is different from the read barcode. The
sample tube and the request are mismatched.
When a rack position is forced, you must ensure that the sample tube is physically
positioned as programmed in the worklist.
Position mode
Samples are identified by rack position. In this mode, the rack position of the sample tube must be
filled in by the operator. The sample ID can be entered by the operator but it is not mandatory.
Working with the position mode, you must ensure that the sample tube is physically
As soon as the instrument reads a sample tube, the associated rack position is searched in the
worklist. The following cases can occur.
1. For example, a tube without barcode is read on the rack position "01.01" and this position is
found in the worklist. The sample tube and the request are matched.
2. A tube with barcode is read on the rack position "01.01" and this position is found in the worklist.
a. The sample ID was not entered by the operator, it is then filled in by the instrument. The
sample ID is identical to the read barcode. The sample tube and the request are matched.
b. The sample ID was not entered by the operator, it is then filled in by the instrument. The
sample ID is different from the read barcode. The sample tube and the request are
mismatched.
c. The sample ID was entered by the operator and it is identical to the read barcode. The sample
tube and the request are matched.
d. The sample ID was entered by the operator and it is different from the read barcode. The
sample tube and the request are mismatched.
Normally, barcodes are not used in this mode. However, when a tube with barcode is
read, the barcode has priority.
■ Patient Sample Request Fields, p.161
■ To Configure Loading Mode, p.302
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6.1.3. Creating a Patient Worklist
6.1.3.1. Patient Sample Request Fields
Patient demographic data
Heading Description Format

Patient ID Patient ID 25 characters maximum
Last Name Patient last name 20 characters maximum
To search for a patient file and to select it. Button
First Name Patient first name 20 characters maximum

Date of Birth Patient date of birth Depending on the configured date
format
Age Patient age 3 numerical characters maximum
Not to be captured by the user.
Gender Man, Woman or Unknown Dropdown list
Displayed when the patient demographic data -
were programmed or modified from the host.
Sample characteristics

Sample ID Sample ID 16 characters maximum
Rack Rack number Dropdown list
Pos. Position number on the rack Dropdown list
To force a rack position in identification mode. Button
Sample type Serum/Plasma, Urine or Other. Dropdown list

Priority Normal or High Dropdown list
Displayed when the sample characteristics were -
programmed or modified from the host.
Batch Number of samples of the batch. From 1 to 100
Relevant only when ordering patient samples by
batch.
Department Department requesting the tests 20 characters maximum
Physician Physician requesting the tests 20 characters maximum
Comment Comment about the sample 50 characters maximum
Collection Date Sample collection date and time Depending on the configured date
and time format
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In order to ensure security of patient identification and sample identification, the space
character is allowed in the patient ID and the sample ID only when this one is placed
inside the capture. The space character is not authorized and is systematically deleted
when this one is the first character or the last character of the capture.
This rule also applies to the host connection and the sample barcode types Code 39 and
Code 128.
Also refer to the Settings > System Configuration > Host Connection > To Configure the
Host Connection chapter.




modified.
6.1.3.3. To Create a Worklist by Position
Follow this procedure to order patient samples by position.
The sample identification mode must be previously configured in position mode. Refer to the Settings
> System Configuration > Analyser > To Configure Loading Mode chapter.
1. Press Add new.

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1 = Patient demographic data

2 = Sample characteristics
3 = Tests selection
4 = Profile tab
5 = OK
2. Fill in the patient demographic data and the sample characteristics.
In position mode, the rack position of the sample tube must be filled in by the operator. The
sample ID can be entered by the operator but it is not mandatory.
For detailed information concerning patient sample request fields, refer to the Creating
a Patient Worklist > Patient Sample Request Fields chapter.
3. Select the tests and ratios to be performed on the sample tube.
■ Press Erase to deselect all the tests and ratios.
■ For detailed information concerning tests selection, refer to the Creating a Patient
Worklist > Tests Selection in the Request Capture Screen chapter.
4. To select several tests using the profiles, proceed as follows:

a. Press the Profile tab.
b. Select the profiles by pressing the corresponding buttons.
■ Profiles must be previously configured in Main menu > Services > Application
Configuration > Profiles.
■ When a profile is selected, all tests included in the profile are selected (unless
the corresponding reagent is inactive).
c. Go back to the Test tab.
5. For each selected test or ratio, configure the number of replicates (from 1 to 20 replicates) as
follows:
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a. Select the test or ratio.

7. Repeat steps 2 to 6 for each patient sample.
Patient sample requests are added in the worklist.
■ To Add a Profile, p.292
6.1.3.4. To Create a Worklist in Batch Mode
Follow this procedure to order patient samples by batch.
1. Press Add new.

1 = Rack dropdown list

2 = Pos. dropdown list
3 = Rack Pos. button
4 = Batch spin box
6 = Tests selection
7 = Profile tab
8 = OK
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Do not fill in the patient demographic data. If at least one field of the patient
demographic data is captured, you will not be able to order samples by batch.
However, once the patient samples are ordered, it is possible to add the patient
demographic data to each sample. Refer to the Patient Worklist > To Modify a Patient
Sample Request chapter.
2. Depending on sample identification mode, proceed as follows to select the rack position of the
first sample tube:
a. In position mode, select the rack position from the Rack and Pos. dropdown lists.
b. In identification mode, press the Rack Pos. button to force the position mode. Then, select the
rack position from the Rack and Pos. dropdown lists.
3. Configure the number of samples of the batch from the Batch spin box.
The maximum value of this field is restricted by the number of consecutive rack positions available
that follow the rack position of the first sample tube.
4. Fill in the sample characteristics.
In position mode, the sample ID can be entered by the operator but it is not mandatory.
In addition, to use the sample ID in batch mode, you have to enter the sample ID of the first
sample tube and this one must contain only digit characters. This sample ID will automatically be
incremented by one for each sample of the batch.
5. Select the tests and ratios to be performed on the batch.

follows:
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9. Repeat steps 2 to 8 for each batch.
■ To Modify a Patient Sample Request, p.168
6.1.3.5. To Create a Worklist by Barcode Identification
Follow this procedure to order patient samples by barcode identification.
■ The sample identification mode must be previously configured in identification mode. Refer to the
Settings > System Configuration > Analyser > To Configure Loading Mode chapter.
■ Sample tubes must be identified by barcode labels.
1. Press Add new.


3 = Tests selection
4 = Profile tab
5 = OK
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In identification mode, the sample ID is mandatory. The rack position of the sample tube must not
be filled in by the operator, it will be filled in by the instrument. However it is possible to force a
rack position by pressing the Rack Pos. button.
When a rack position is forced, you must ensure that the sample tube is physically

follows:
6.1.3.6. Creation of a Worklist from the Host
To order patient samples from the host, the following conditions must be met:
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■ The sample identification mode must be previously configured in identification mode. Refer to the
Settings > System Configuration > Analyser > To Configure Loading Mode chapter.
■ The host connection must be configured. Refer to the Settings > System Configuration > Host
Connection > To Configure the Host Connection chapter.
If the two conditions above are met, the patient sample requests programmed from the host are sent
to the instrument and added in the worklist.
6.1.4. To Modify a Patient Sample Request
Follow this procedure to modify a patient sample request.
1. Select the patient sample request and press Details.

2. Press Edit.
The patient sample request must be ordered or pending but not incomplete.
3. Modify the patient demographic data if necessary.
The patient demographic data can be modified from the instrument only if it was manually entered
from the instrument. If it was programmed from the host, it must be modified from the host. When
a patient file is modified (either from the instrument or from the host), all validated and archived
sample ID for this patient are flagged with an asterisk.
4. Modify the sample characteristics if necessary.
The sample characteristics can be modified from the instrument only if they were manually entered
from the instrument. If they were programmed from the host, they must be modified from the host
(except the sample tube priority).
The sample ID and the sample type cannot be modified (either from the instrument or from the
host).
5. Modify the tests and ratios to be performed on the sample tube.
follows:
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6.1.5. To Delete Patient Sample Requests
Follow this procedure to delete patient sample requests from the worklist.
1. Select the patient sample request and press Delete.

The patient sample request must be ordered or pending but not incomplete.
3. Repeat steps 1 and 2 for each patient sample request that you want to delete.
6.2. To Load Patient Samples on the Analyser
Follow this procedure to place patient samples on the sample tray.
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1 = Configured positions
1. Place the patient samples on racks.
In identification mode, the sample tubes with barcode labels can be placed randomly
on the sample tray.
2. Load the racks on the sample tray.
turn green.
6.3. Work Balance
The Work Balance menu allows you to assess the reagents on board relative to the analyses to be
performed.
This menu is divided into two tabs:
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■ Reagent supply
6.3.1. Reagent supply
The solutions are associated with a color code:

■ Green when the solution volume remaining in the cassette is sufficient for the pending tests.
■ Red when the solution will be missing.
■ Black when the solution is not provided in a cassette. The work balance is then not effective.
Heading Description
Solution requested Solution short name
Capacity requested ■ Cassette: Number of tests to be performed.
■ Open cassette or reagent rack: Solution volume necessary for the tests
to be performed (without taking into account the dead volume).
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Heading Description
Present on reagent tray ■ Reagent: Number of tests that can be performed with the solution
volume remaining in the cassette.
■ Diluent or cleaner: Solution volume remaining in the cassette.
Only for cassette.
Position ■ Cassette or open cassette: Position number on the reagent tray.
■ Reagent rack: First position number on the reagent tray + rack sector.
On tray If selected, the solution is present on the reagent tray.
Access: Main menu > Work Balance > Sampling Exception
The Sampling Exception tab displays the pending tests for which a sampling alarm will be triggered.
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Heading Description
6.3.3. To Anticipate Reagent Shortage and Sampling Alarms
Follow this procedure to assess the reagents on board relative to the analyses to be
performed.
The instrument checks the solutions on board (barcodes reading) on reagent and sample trays. It
takes a few minutes.
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1 = Tubes on tray option

2 = Worklist option
1. Select either Tubes on tray or Worklist option.

The solutions appearing in red will be missing.
2. Physically check the solutions in red and replace them if necessary. Physically check the solutions
in black and if necessary refill them with the requested volume (do not forget to add the dead
volume). Solutions in green do not require an additional check.
3. Press the Sampling Exception tab.

The Sampling Exception tab displays the pending tests for which a sampling alarm will be
triggered.
4. Check the expected sampling alarms.
■ Reagent supply, p.125
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6.4. To Start Analyses
Follow this procedure to a run patient sample, calibration or control.
Before running samples, the following conditions must be fulfilled:

■ The following items must have been checked:
■ waste level,
■ The mixer must be in place.
■ Covers must be closed.
1. Press Start.
Before performing the analyses, the reagent tray temperature is checked and if it is out of range, a
dialog box is displayed: The current reagent tray temperature [temperature] is out of the range
(acceptable range). The results can be affected by this malfunction. We recommend you to perform
controls. Do you still want to run analysis?
This message means that the reagents refrigeration does not work properly and this
can generate erroneous test results.
■ Press Cancel to cancel the analyses without any warning. This will allow you to perform the
appropriate controls before performing the analyses.
■ Press OK to perform the analyses in spite of this message. The analyses are performed and
the warning #642 Worklist performed with reagent tray temperature [temperature] out of the
range (acceptable range) is triggered.
1 = Instrument status
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6.5. To Run Additional Patient Samples or a Stat Sample
Follow this procedure to run additional patient samples or a stat sample when the
instrument is in "Sampling" status.
1. Press Pause to stop samplings on the sample tray and wait for the LED to turn green.
2. Place the additional patient samples or the stat sample on the sample tray.
turn green.
In identification mode, the sample tubes with barcode labels can be placed randomly
on the sample tray.
3. Enter Main menu > Worklist > Patient.

4. Press Add new.
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3 = Tests selection
4 = Profile tab
5 = OK
■ For a stat sample, set the sample tube priority to High.

■ For detailed information concerning patient sample request fields, refer to the
Creating a Patient Worklist > Patient Sample Request Fields chapter.

follows:
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11. Press Start.
The additional patient samples or the stat sample are run. For a stat sample, this one is run in priority
before any sample remaining in the worklist.
If the instrument is in "Reagent processing" or "Analysing" status, skip steps 1 and 11.
6.6. Sample Status
6.6.1. Sample Workflow
Samples successively go through the status listed below.
Status Description
Ordered The sample is requested in the worklist.
Pending The sample is read on the tray.
Incomplete At least one test of the sample is pipetted.
For validation All tests of the sample are finished and for validation.
Validated All tests of the sample are validated.
Archived The sample is archived.
6.6.2. Sample Tray Description
The sample tray is symbolized in the middle of the main menu. It allows you to visualize samples
The sample tray contains 60 sample positions and can hold sample racks, sample cup racks and
calibrator/control sample racks.
The status of each sample is indicated by a color code to which a legend is available by pressing the
blue background inside the sample tray.

Available The sample is validated.
Unknown The sample is detected on the tray but not associated

with a request in the worklist yet.
In Progress The sample is pending, incomplete or for validation.
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For Verification The sample needs to be checked because of a
sampling alarm.
Empty Empty position
You can access the sample rack details by pressing a position on the sample tray.
Heading Description
Status Pending, Incomplete, For validation or Validated
Sample ID Sample ID
Last Name Patient last name
Sample Type Serum/Plasma, Urine or Other.
6.6.3. To Check Sample Status
Follow this procedure to check the status of each sample configured on the sample tray.
1 = Sample tray
2 = Sample requiring an additional check
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1. Check the status of each sample configured on the sample tray from the main menu.
The status of each sample is indicated by a color code on the sample tray. The samples appearing
in red require an additional check because of a sampling alarm.
2. Check the samples in red by referring to the Patient Samples > Test Review > To Check Sampling
Alarms and Analytical Flags chapter.
■ To Check Sampling Alarms and Analytical Flags, p.136
■ Sample Tray Description, p.178
6.7. Test Review
The Test Review menu allows you to review the tests in progress, to check sampling alarms and
analytical flags that may have been triggered and to manually export results to a USB key at each end
of run.
■ Test Result
■ Error Report
■ Sequencing
6.7.1. Test Result
The Test Result tab displays the tests in progress as soon as they are pipetted.
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Heading Description
Status Ordered, Pending, Incomplete, For validation or Validated
an analytical flag.
displayed).
Dec. Decision:
■ Blank: Accept or Delete.
■ Calibration: Not displayed.
■ Control: Accept or Delete.
■ Patient sample: Accept, Rerun, Modify or Delete.
The Export button allows you to manually export results to a USB key. Refer to
the Test Review > To Manually Export Results to a USB Key chapter.
■ To Manually Export Results to a USB Key, p.137
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The tab is cleared at instrument startup and when starting analyses.
Heading Description
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6.7.3. Error Report
Access: Main menu > Test Review > Error Report
An item is deleted as soon as a decision on the test is made.
Heading Description
an analytical flag.
Analysis flag Analytical flag (only the flag having the highest priority is displayed).
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6.7.4. Sequencing
Access: Main menu > Test Review > Sequencing

■ every mixing,
Events are listed in table formats which are described below.

Reagent Arm
Heading Description
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Heading Description
Sample Arm
Heading Description
volume
on the rack,
Other
Heading Description
number on the tray
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6.7.5. To Check Sampling Alarms and Analytical Flags
Follow this procedure to check sampling alarms and analytical flags that may have been
triggered.
The Test Review button becomes red when a sampling alarm or an analytical flag is triggered.
1. Check the tests for which a sampling alarm is triggered.

2. Press the Error Report tab.
3. Check the tests for which an analytical flag is triggered.
Refer to the Alarms > Analytical and Quality Flags chapter.
■ Error Report, p.133
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6.7.6. To Manually Export Results to a USB Key
Follow this procedure to manually export results to a USB key at the end of run.
■ The Test Result tab should not be empty.

■ The instrument must be in the "Ready" or the "Emergency Stop" status.
Results are automatically exported to a USB key at each end of run if the Activate export
of the results on USB key option is selected in Main menu > Services > System
Configuration > Analyser. Refer to the Settings > System Configuration > Analyser > To
Enable or To Disable Automatic Export of Results chapter.
instrument.
2. Press the Export button:
All the completed test results are saved in a .csv file located in a folder named "Export" on the USB
key. ISE test results and ratio results are not exported.
.csv file example
■ To Enable or To Disable Automatic Export of Results, p.310
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6.8. Patient Results Validation
Access: Main menu > Result Validation > Patient
The patient result list displays all patient sample results that are incomplete, for validation or validated,
as well as the patient sample results that are ordered or pending and having at least one test of the
sample finished.
Patient sample results are sorted by patient ID and by date. Alternation of white and blue materializes
the separation between patient ID.
You can select the patient sample results to be displayed from the following options:
■ Incomplete: To display patient sample results that are incomplete as well as patient sample
results that are ordered or pending and having at least one test of the sample finished.
■ For validation: To display patient sample results that are for validation.
■ Validated: To display patient sample results that are validated.
■ All: To display all patient sample results.
This list is cleared when a new worklist is created.
Patient sample results are listed in a table format which gives the following information.
Heading Description
Status Sample status: Ordered, Pending, Incomplete, For validation or Validated
Sample ID Sample ID
Run Date Sample run date and time
Collection Date Sample collection date and time
The Patient tab allows you to check patient results.
6.8.1. Patient Results Interpretation
For detailed information concerning the procedure to check patient results, refer to the
Patient Results Validation > To Make a Decision on Patient Results chapter.
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The result validation screen displays the following items:

■ The patient demographic data and the sample characteristics (top of the screen).
■ The patient results in the Result tab.

■ The kinetic curve for each test in the O.D. Values tab.
■ The last control results for each test in the Control tab.
Patient results
Heading Description
Pos. Rack position of the sample tube
To display several results for a test in case of rerun or result modification.
Result(s) Final result.
an analytical flag.
displayed).
DC Delta check flag (D+ or D-)
Dec. Decision: Accept, Rerun, Modify or Delete
Previous Previous result
Previous date Sample run date and time
Reference Range Low and high limit values of the Man/Default reference range
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■ For a ratio result, the ratio is displayed on the first line and then its included tests and
sub-ratio (if any) are displayed in gray on the following lines.
■ For detailed information concerning analytical flags or quality flags, refer to the Alarms
> Analytical and Quality Flags chapter.
Kinetic curve for a test

You can display the kinetic curve for a test by selecting a result in the Result tab and pressing the
O.D. Values tab.
The O.D. Values tab is unavailable for ISE test results, ratio results and for results coming
from rerun or result modification.
■ X-axis: time,
■ Green line: kinetic curve.
correlation coefficient r2 is calculated and displayed.
Data of the kinetic curve is also displayed in a table format (left side of the screen).
Control results for a test

You can display the last control results for a test by selecting a result in the Result tab and pressing
the Control tab.
The Control tab is unavailable for ratio results and for results coming from rerun or result
modification.
Heading Description
Default If selected, the control is a default control for this test.
Name Control name
Run date Date and time of control run
On orange background if the control and the sample are not performed the
same day or if the control and the sample do not use the same calibration.
Result(s) Final result. On red background if out of confidence range.
an analytical flag.
displayed).
Dec. Decision: Accept or Delete
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■ To Make a Decision on Patient Results, p.191
6.8.2. To Make a Decision on Patient Results
Follow this procedure to manually validate or to manually modify a patient result, as well
as to rerun or to delete a patient test.
Patient results are automatically validated depending on the patients automatic validation configured
in Main menu > Services > System Configuration > Results validation.

2 = Patient results selection
3 = Details
1. Select the For validation option to display the patient sample results that are for validation.
2. Select the patient results that you want to review and press Details.
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4 = Edit
5 = Test selection
6 = Result selection
7 = Decision selection
8 = OK
3. Check the patient results and make sure that no analytical flag or quality flag has been triggered.
For detailed information concerning patient results interpretation, refer to the Patient
Results Validation > Patient Results Interpretation chapter.
4. Press Edit.
5. Make a decision for each test as follows:
a. Select a test.
b. In case of rerun or result modification, press to display all results for the test and select a
result by double-clicking the corresponding colored button.
The colored button is:
■ Green when the result is selected,
■ Orange when the result is selectable,
■ Red when the result is not selectable.
The selected result becomes the final result.
c. Select a decision from the following options:
■ Accept: To validate the test result.
■ Rerun: To rerun the test. Up to three reruns can be performed (manual or automatic).
■ Modify: To manually modify the test result.
A ratio result cannot be manually modified.
■ Delete: To delete the test.

Decisions are authorized depending on the test status.
Status Accept Rerun Modify Delete

Test in progress No No No No
Not given result No No No Yes
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Status Accept Rerun Modify Delete

Result without flag Yes Yes Yes Yes
Invalid result (sampling alarm) No No No Yes
Invalid result (flag) No Yes Yes Yes
Validated result No No No No
Press Erase to cancel the decision.
d. Repeat steps a to c for each test.
You can make a decision on a ratio result but not on its included tests and sub-ratio (if
any).
■ To Configure Patients Automatic Validation, p.327
■ Patient Results Interpretation, p.188
6.8.3. To Add Tests on a Patient Sample
Follow this procedure to add tests on a patient sample from the result validation screen.
1. Select the All option to display all patient sample results.

2. Select the patient sample on which you want to add tests and press Details.
3. Press Add new.

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follows:
6.8.4. To Print Patient Results
Follow this procedure to manually print patient results.
Patient results are automatically printed when validated if configured in Main menu > Services >
1. Select the For validation option to display the patient sample results that are for validation or the
Validated option to display the patient sample results that are validated.
2. Select the patient results that you want to print and press Data Print/Send to Host from the
generic toolbar.
3. Select the Order option to print all results of the selected patient (results of all samples) or the
Selected Sample option to print only results of the selected sample.
■ condensed,
■ standard,
■ detailed,
■ portrait.
Detailed and portrait printout formats are unavailable if the Order option is selected.
The validated results of the selected patient (results of all samples) or of the selected sample are
printed.
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Printout format: condensed
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Printout format: portrait

6. To print the kinetic curve for a test, proceed as follows:
a. Select the patient results that you want to print and press Details.
b. Display the kinetic curve that you want to print by selecting a result in the Result tab and
pressing the O.D. Values tab.
c. Press Data Print/Send to Host from the generic toolbar.
d. Press OK to validate or Cancel to cancel.
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6.8.5. To Print Patient Results of a Working Day
Follow this procedure to print all patient results of a working day as a condensed list.
Access: Main menu > Archives > Worklist/SID Search
1. Search for the worklist that you want to print as follows:

a. Type the worklist date in Beginning Date and Ending Date fields.
b. Press Search.
The worklists corresponding to the search criteria are displayed.
c. Select the worklist that you want to print.
Patient results of the selected worklist are printed as a condensed list.
6.8.6. To Print Patient Results Sorted by Test
Follow this procedure to print patient results sorted by test.
Access: Main menu > Archives > Export
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2. The Patient option is selected by default.
This option allows you to print the patient results. Do not deselect the Patient option nor select
the Controls or Calibration option.
3. The Validated only option is selected by default.
This option allows you to print only validated results.
4. Select the tests that you want to print from the Tests list.
By default, all tests are selected to be printed. If necessary, deselect the tests that should not be
printed.
Results are displayed in the Results found table.

6. Select the test results that you want to print from the Results found table.
By default, all test results are selected to be printed. If necessary, deselect the test results that
should not be printed.
The selected test results are printed.
6.8.7. To Send Patient Results to the Host
Follow this procedure to manually send patient results to the host.
The patient results must be previously validated.
Patient results are automatically sent when validated if configured in Main menu > Services >
System Configuration > Host Connection.
1. Select the Validated option to display the patient sample results that are validated.
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2. Select the patient results that you want to send and press Data Print/Send to Host from the
generic toolbar.
3. Press Send.
The Send window is displayed.
4. Select the Order option to send all results of the selected patient (results of all samples) or the
Selected Sample option to send only results of the selected sample.
The validated results of the selected patient (results of all samples) or of the selected sample are
sent.
6.9. Patient Results Archives
Access: Main menu > Archives
Results are archived when a new worklist is created.

Up to 100000 results (patient, calibration and control results) are archived in the current database.
Beyond this number, the oldest are deleted from the current database and saved in archive files on
the hard disk.
Archive files are automatically saved at instrument startup every six months or when more than
100000 results are archived in the current database. Up to 100000 results are stored in one archive
file.
The Archives menu allows you to search for archived results in the current database as well as in the
archive files saved on the hard disk or a USB key. The search is done either by worklist and sample ID
(only in the current database) or by patient.
The Archives menu allows:
■ To search for archived results in the current database. The search is done either by worklist and
sample ID or by patient.
■ To search for archived results in the archive files saved on the hard disk or a USB key. The search
is done only by patient.
■ To export archived results from the current database in a .csv file on a USB key.
■ To Search for Archived Results by Worklist/SID, p.200
■ To Search for Archived Results by Patient, p.201
■ To Search for Results in the Archive Files, p.202
■ To Export Archived Results to a USB Key, p.204
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6.9.1. To Search for Archived Results by Worklist/SID
Follow this procedure to search for archived results in the current database by worklist
and sample ID.
Access: Main menu > Archives > Worklist/SID Search
1. Search for the worklist that you want to review as follows:

a. Type the worklist date in Beginning Date and Ending Date fields.
b. Press the Search button:
The worklists corresponding to the search criteria are displayed.

c. Select the worklist that you want to review.
Patient sample results of the selected worklist are displayed at the bottom of the screen.
2. Search for the sample ID that you want to review as follows:
a. Type the sample ID (16 characters maximum) in the Sample ID field.
The sample ID corresponding to search criteria are displayed.

c. Select the sample ID that you want to review.
3. Press Details to review the selected patient sample results.
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6.9.2. To Search for Archived Results by Patient
Follow this procedure to search for archived results in the current database by patient.
Access: Main menu > Archives > Search by PID/Patient Name
1. Search for the patient that you want to review as follows:

a. Type either the patient ID in the Patient ID field or the patient name in the Patient Name field.
Type the first characters of patient ID or patient name followed by an asterisk to

search patient ID or patient names starting with the entered characters.
The patients corresponding to the search criteria are displayed.

c. Select the patient that you want to review.
Results of the selected patient are displayed at the bottom of the screen. Results are listed by run
date in a table format which indicates the tests performed, the test unit, the test result and the
2. Select the run date that you want to review and press Details.
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Patient Samples
6.9.3. To Search for Results in the Archive Files
Follow this procedure to search for results in the archive files saved on the hard disk or a
USB key.
1. Search for the patient that you want to review as follows:

a. Type either the patient ID in the Patient ID field or the patient name in the Patient Name field.
Type the first characters of patient ID or patient name followed by an asterisk to

search patient ID or patient names starting with the entered characters.
b. Press the Archive Search button:
A dialog box allows you to select the support type:

■ hard disk (internal),
■ USB key.
c. If you use a USB key, install it on your instrument.
HORIBA Medical recommends you to make sure that all materials like CD-ROM or
USB key used on the Pentra C400 and non-referenced by HORIBA Medical are free
of viruses. These materials must imperatively be cleaned before being used on the
instrument.
d. Select the support type and press OK to validate.

The patients corresponding to the search criteria are displayed.
2. Select the patient that you want to review from the Patient List area (left side of the screen).
The archive files available for the selected patient are displayed in the Archives List area (right
side of the screen).
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Patient Samples
If no patient is selected from the Patient List area, all available archive files are
displayed in the Archives List area.
3. Select the archive file that you want to open and press Details.
Once you have selected an archive file, you can consult logs and control results of the selected
archive file by pressing respectively Logs or Quality Control.
Results of the selected patient are displayed at the bottom of the screen. Results are listed by run
date in a table format which indicates the tests performed, the test unit, the test result and the
Refer to the Patient Results Archives > To Search for Archived Results by Patient chapter.
If no patient is selected from the Patient List area, worklists of the selected archive file
are displayed.
Refer to the Patient Results Archives > To Search for Archived Results by Worklist/SID
chapter.
■ To Search for Archived Results by Worklist/SID, p.200
■ To Search for Archived Results by Patient, p.201
■ To Save the Archive Files on a USB Key, p.203
6.9.4. To Save the Archive Files on a USB Key
Follow this procedure to save the archive files from the hard disk on a USB key.
1. Press the Archive Search button:

■ USB key.
2. Select the hard disk and press OK to validate.
The archive files saved on the hard disk are displayed in the Archives List area.
instrument.
4. Press Export:
The archive files are saved on the USB key.
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Patient Samples
6.9.5. To Export Archived Results to a USB Key
Follow this procedure to export archived results from the current database in a .csv file to
a USB key.
Access: Main menu > Archives > Export

2. Select the results that you want to export from the following options.
■ Patient
■ Controls
■ Calibration
By default, only the Patient option is selected.
3. The Validated only option is selected by default.
This option allows you to export only validated results.
4. Select the tests that you want to export from the Tests list.
By default, all tests are selected to be exported. If necessary, deselect the tests that should not be
exported.
Results are displayed in the Results found table.
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Patient Samples
6. Select the test results that you want to export from the Results found table.
By default, all test results are selected to be exported. If necessary, deselect the test results that
should not be exported.
7. Select the Include OD option to export the absorbance values of kinetic curves.
8. Press Export:
A dialog box asks you to confirm that the USB key is in place.
instrument.

A dialog box informs you when the export is completed.
11. Press OK.
The selected test results are saved in a .csv file located in a folder named "Export" on the USB key.
.csv file example
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Common Tasks in a Working Day
7. Common Tasks in a Working Day
7.1. Standby Mode
7.1.1. Entering Standby Mode
The instrument can be switched to standby mode either manually or automatically if automatic
standby mode is programmed.
The instrument standby mode consists in switching the spectrophotometer lamp to standby mode.
7.1.1.1. To Manually Enter Standby Mode
Follow this procedure to manually enter standby mode.

The instrument must be in the "Ready" status.
1. Press Exit from the generic toolbar.

1 = Stand by option
2 = ISE Cleaning option
3 = ISE Cleaning dropdown list
4 = System Cleaning option
5 = System Cleaning dropdown list
6 = OK
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2. Select the Stand by option.

3. If you programmed an ISE module cleaning during the instrument shutdown by default, you can
clean the ISE module before entering standby mode as follows:
a. Select the ISE Cleaning option.
b. Choose ETCH (ABX Pentra Etching CP A11A01769) from the ISE Cleaning dropdown list.
■ The ISE module should be cleaned with ABX Pentra Etching CP A11A01769 every
day only if more than 20 samples are run daily.
■ If less than 20 samples are run daily, deselect the ISE Cleaning option and perform
a complete ISE module cleaning every week. Refer to the Maintenance and
Troubleshooting > Maintenance > Weekly Procedures > To Clean the ISE Module
(Option) chapter.
The ABX Pentra Etching CP A11A01769 must be previously configured in the

Reagent Configuration menu and placed on the reagent tray at room temperature.
4. If you programmed a needle cleaning during the instrument shutdown by default, you can clean
the needles before entering in standby mode as follows:
a. Select the System Cleaning option.
b. Choose DEPR (ABX Pentra Deproteinizer CP A11A01754) from the System Cleaning
dropdown list.
The ABX Pentra Deproteinizer CP A11A01754 must be previously configured in the

Reagent Configuration menu and placed on the reagent tray.
■ ISE module and/or needles are cleaned if required.

■ The instrument enters standby mode and the Startup window is displayed.
■ To Configure Automatic Standby Mode, p.207
■ To Configure Automatic Cleanings, p.306
7.1.1.2. To Configure Automatic Standby Mode
Follow this procedure to configure automatic standby mode.
Access: Main menu > Services > System Configuration > Analyser
If an automatic standby mode is programmed, the instrument automatically enters standby mode after
a specified inactivity time.
1. Press Edit.
2. Select the Standby mode check option to enable automatic standby mode.
3. Specify the inactivity time.
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7.1.2. To Quit Standby Mode
Follow this procedure to restart the instrument when it is in standby mode.
The Startup window must be displayed.

2 = Password field
3 = OK
The main menu is displayed and the instrument initialization is performed.
7.2. To Change User
Follow this procedure to change the user name or login during the day of work without
instrument initialization.


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1 = Change User
2 = OK
2. Select the Change User option.
The Startup window is displayed.

4 = Password field
5 = OK
7.3. To Create a New Worklist
Follow this procedure to create a new worklist during the day of work without instrument
initialization.
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1 = Change User
2 = OK
2. Select the Change User option.
The Startup window is displayed.

4 = Password field
5 = New Worklist option
6 = OK
6. Select the New Worklist option.
This option allows you to begin a new day of work. This means that a new worklist is created and
the previous worklist is archived.
Samples of the previous worklist are either deleted if they are ordered or pending, or archived if
they are incomplete, for validation or validated.
Sample identifiers (sample ID or rack position, depending on sample identification mode) are
cleared for the new worklist.
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Patient ID are not cleared for the new worklist.
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End of Day
8. End of Day
8.1. To Check the Patient Worklist
Before performing end of day procedure, make sure that no analysis is pending in the
patient worklist.
1. Make sure that the patient worklist is empty.

2. If not, check each patient sample request and either run or delete the patient sample.
3. Enter Main menu > Result Validation > Patient.
4. Select the Incomplete option to display the patient sample results that are incomplete as well as
the patient sample results that are ordered or pending and having at least one test of the sample
finished.
5. If patient sample results are displayed, make a decision on each test (refer to the Workflow >
Patient Samples > Patient Results Validation > To Make a Decision on Patient Results chapter).
6. Select the For validation option to display the patient sample results that are for validation.
7. If patient sample results are displayed, make a decision on each test (refer to the Workflow >
Patient Samples > Patient Results Validation > To Make a Decision on Patient Results chapter).
■ To Delete Patient Sample Requests, p.169
■ To Make a Decision on Patient Results, p.191
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End of Day
8.2. To Check the Instrument
At the beginning of each day (before startup) or at the end of each day (before shutdown),
check the following items:
■ waste level,
1. Check the distilled water level in the tank. Fill the tank if necessary.
2. Check the waste level in the tank. Empty the tank if necessary.
protection, etc.). Follow your local and/or national guidelines for biohazard waste
disposal.
■ At the beginning of each day, before startup, check if the waste container needs to
be emptied.
circumstance.

reaction tray.

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End of Day
7. For Pentra C400 with ISE module (option), open the ISE module cover to check levels of ISE
reagents.
8. If an ISE reagent needs to be replaced, refer to the Maintenance and Troubleshooting >
■ ISE reagents running dry can damage the electrodes.

Ensure that there is always enough ISE reagents to perform the ISE module
calibrations.
■ To minimize environmental interferences, the ISE module cover must always be
8.3. To Shut Down the Instrument
Follow this procedure to shut down the instrument at the end of the day.
■ Automatic cleanings must be programmed in Main menu > Services > System Configuration >
Analyser.
■ The main menu must be displayed.

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End of Day
1 = Shutdown option
2 = Startup date
3 = ISE Cleaning option
4 = ISE Cleaning dropdown list
5 = System Cleaning option
6 = System Cleaning dropdown list
7 = OK
2. Select the Shutdown option.
3. If an automatic startup is programmed, the instrument automatically starts the next day at a
specified time. In case of day off, change the startup date.
4. If you programmed by default an ISE module cleaning at the instrument shutdown, the ISE
Cleaning option is selected by default. Choose ETCH (ABX Pentra Etching CP A11A01769) from
the ISE Cleaning dropdown list.
■ If less than 20 samples are run daily, deselect the ISE Cleaning option and perform
a complete ISE module cleaning every week. Refer to the Maintenance and
Troubleshooting > Maintenance > Weekly Procedures > To Clean the ISE Module
(Option) chapter.
The ABX Pentra Etching CP A11A01769 must be previously configured in the

Reagent Configuration menu and placed on the reagent tray at room temperature.
5. If you programmed by default a needles cleaning at the instrument shutdown, the System
Cleaning option is selected by default. Choose DEPR (ABX Pentra Deproteinizer CP
A11A01754) from the System Cleaning dropdown list.
The ABX Pentra Deproteinizer CP A11A01754 must be previously configured in the

Reagent Configuration menu and placed on the reagent tray.
ISE module and/or needles are automatically cleaned before the instrument shutdown:
■ reaction tray check (used cuvette segments are unloaded from the reaction tray),
■ temperature regulation switching off,
■ computer and spectrophotometer lamp switching off.
7. Wait for the end of instrument shutdown. If the ABX Pentra Etching CP A11A01769 was
previously placed on the reagent tray, remove it from the tray, close it and store it at room
temperature.
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End of Day
8. Ensure that position 36 of the reagent tray is in front of the yellow triangle.
The Pentra C400 hardware has to remain on 24 hours a day. This is necessary to keep the
cooling unit functionnal and therefore maintain the temperature in the refrigerated area of
the reagent tray. Do not switch off neither the Pentra C400 nor the cooling unit.
If you want to switch the Pentra C400 and the cooling unit off for several days, remove the
reagents from the tray, close them and place them in a refrigerated area. For Pentra C400
with ISE module (option), refer to the Maintenance and Troubleshooting > Maintenance >
Other Procedures > ISE Module Shutdown (Option) chapter.
■ To Configure the Automatic Startup, p.305
■ To Clean the ISE Module (Option), p.341
8.4. To Switch the Printer Off
Switch the printer off at the end of the day.
1. Make sure that no printout has been launched.

2. Switch the printer off.
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Settings
1. Reagent Management...................................................................................................... 218

1.1. Reagent Configuration Overview............................................................................................... 219
1.2. Managing Cassettes.................................................................................................................. 221
1.3. Managing Reagents in an Open Cassette................................................................................. 224
1.4. Managing Reagents on a Reagent Rack................................................................................... 227
2. Calibration and Control Configuration.......................................................................232

2.1. Calibrators Configuration........................................................................................................... 232
2.2. Controls Configuration............................................................................................................... 241
2.3. ISE Calibration Configuration (Option)....................................................................................... 250
3. Application Configuration............................................................................................... 252

3.1. Application Configuration Overview...........................................................................................252
3.2. Absorbance Applications........................................................................................................... 253
3.3. ISE Applications (Option)........................................................................................................... 275
3.4. To Configure the Applications Order......................................................................................... 280
3.5. Updating the Applications..........................................................................................................280
3.6. Ratios......................................................................................................................................... 284
3.7. Profiles....................................................................................................................................... 291
3.8. Incompatibilities......................................................................................................................... 293
3.9. Reagents.................................................................................................................................... 297
4. System Configuration....................................................................................................... 301

4.1. Analyser......................................................................................................................................301
4.2. Local Settings............................................................................................................................ 312
4.3. Host Connection........................................................................................................................ 318
4.4. Printer.........................................................................................................................................322
4.5. Results Validation.......................................................................................................................325
4.6. To Configure Sound Alarms.......................................................................................................328
4.7. Configuring Maintenance Alerts.................................................................................................329
4.8. Users.......................................................................................................................................... 331
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Reagent Management
1. Reagent Management
Three solution types are programmable on the Pentra C400:

■ reagents,
■ diluents,
■ cleaners.
Reagents mean the reagents that are programmed in the application as R1, R2 and R3. These
reagents are directly linked to the application by the reagent short name. Diluents and cleaners are
shared between several applications.
positions at room temperature.
The reagent tray can hold reagent cassettes, reagent racks and calibrator/control reagent racks.
■ The cassettes and the open cassettes occupy one position per cassette on the tray. The cassettes
are either single compartment or twin compartment containers. One cassette is dedicated to a
single solution: either a reagent, a diluent or a cleaner.
■ The reagent racks occupy four positions per rack on the tray. The reagent racks are cut into three
sectors (each of three positions) and can accomodate either three reagents, diluents or cleaners or
a combination of the above (for example: one reagent and two diluents) in reagent vials of 4 mL,
10 mL and 15 mL.
■ The calibrator reagent racks occupy one position per rack on the tray. These racks can
accomodate up to three different calibrators in sample cups (with adaptors).
■ The control reagent racks occupy one position per rack on the tray. These racks can accomodate
up to three different controls in sample cups (with adaptors).
■ The temperature of the refrigerated positions 1, 2, 43 and 44 may be higher than

required depending on the room temperature. It is recommended to use these
positions for diluents, cleaners, calibrators or controls.
■ To use reagent racks or calibrator/control reagent racks, you must ensure that the
solutions are physically positioned as configured in the Reagent Configuration menu.
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1.1. Reagent Configuration Overview
Access: Main menu > Reagent Configuration
The Reagent Configuration menu is divided into two tabs:

■ Tray
■ Configuration
Tray
The 52 positions of the reagent tray are symbolized in the Tray tab. It allows you to visualize solutions
The status of each solution is indicated by a color code to which a legend is available by pressing the
blue background.

OK ■ Cassette: The cassette is available for analysis with
sufficient volume.
■ Reagent rack: A solution is configured on this rack
sector.
Reserve backup Back-up cassette (only for cassette)
Low Volume There is less than 10% of the initial volume remaining
(only for cassettes).
To be checked The solution needs to be checked because of one of the
following reasons:
■ The cassette is empty.
■ The solution is unknown (bad barcode for example).
■ Not enough solution for the pending analyses.
■ The solution is inactive.
■ The solution has reached its use limit date or has
expired.
Available Empty position
You can access solution details by pressing a position. The displayed information varies depending
on whether the solution is in a cassette, in an open cassette, on a reagent rack or on a calibrator/
control reagent rack.
■ Cassette: Refer to the Reagent Management > Managing Cassettes > Cassette Screen chapter.
■ Open cassette: Refer to the Reagent Management > Managing Reagents in an Open Cassette >
Open Cassette Screen chapter.
■ Reagent rack: Refer to the Reagent Management > Managing Reagents on a Reagent Rack >
Reagent Rack Screen chapter.
■ Calibrator/control reagent rack: Displays the rack ID and the position number on the reagent
tray as well as the characteristics (name, lot number and expiration date) of each calibrator/control
configured on the rack.
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Configuration
The Configuration tab lists the solutions configured on the instrument. Solutions are either
automatically configured after installation on board (for solutions in a cassette or in an open cassette)
or manually configured on a reagent rack.
You can select the solutions to display from the following options.
■ Current: To display all solutions currently configured on the instrument.
■ Active current: To display only the active solutions currently configured on the instrument.
■ Inactive current: To display only the inactive solutions currently configured on the instrument.
■ ABX cassettes run out: To display the deleted cassettes.
Cassettes are automatically deleted when they are empty or definitively deactivated.
Heading Description
Solution Solution type: Reagent, Diluent or Cleaner
Rack ID Cassette barcode or rack ID
Rack Type Container type: Cassette or Reagent Rack
Reagent Short Name Solution short name
Configuration Number of reagents: Reagent 1, Reagent 2 or Reagent 3
Filling Volume R1 initial volume.
Only for cassette.
Expiration Date Expiration date before opening.
Only for cassette.
Installation Date Installation on board date and time.
Only for cassette.
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Heading Description
Use Limit Date Expiration date after installation on board.
Only for cassette.
Available Tests Number of tests that can be performed with the solution volume remaining
in the cassette.
Only for cassette.
You can access solution details by selecting a solution and pressing Details. The displayed
information varies depending on whether the solution is in a cassette, in an open cassette or on a
reagent rack.
■ Cassette: Refer to the Reagent Management > Managing Cassettes > Cassette Screen chapter.
■ Open cassette: Refer to the Reagent Management > Managing Reagents in an Open Cassette >
Open Cassette Screen chapter.
■ Reagent rack: Refer to the Reagent Management > Managing Reagents on a Reagent Rack >
Reagent Rack Screen chapter.
■ Cassette Screen, p.221
■ Open Cassette Screen, p.225
■ Reagent Rack Screen, p.228
1.2. Managing Cassettes
The solutions provided by HORIBA Medical in a cassette are automatically configured in Reagent
Configuration menu after installation on board.
1.2.1. Cassette Screen
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This screen is accessible either from the Tray tab by pressing a position or from the
Configuration tab by selecting a solution and pressing Details.
The Cassette screen displays the selected cassette (left side of the screen) and the selected solution
characteristics (right side of the screen).
Heading Description
ID Cassette barcode
Tray Sector Position number on the reagent tray
Solution Type Solution type: Reagent, Diluent or Cleaner
Reagent Solution Name Solution short name
Lot Solution lot number
Analysis Method Number of reagents: Reagent 1 or Reagent 2
Reagent Status Solution status: Active or Inactive
Installation Date Installation on board date and time.
Expiration Date Expiration date before opening.
Use Limit Date Expiration date after installation on board.
Volume R1 initial volume.
When a new cassette is installed on the reagent tray, it is automatically activated unless a cassette of
the same solution is already active.
Several cassettes of the same solution cannot be active simultaneously on the reagent tray. If several
cassettes of the same solution are installed on the reagent tray, then the first installed cassette is
active and the next cassettes are inactive.
If the automatic back-up cassette option is enabled, the next cassettes are called back-up cassettes.
Back-up cassettes are automatically activated when the cassette in use is empty.
Refer to the Settings > System Configuration > Analyser > To Configure the Automatic
Back-up Cassette Option chapter to configure the automatic back-up cassette option.
Empty cassettes are automatically deactivated.

When a new cassette is activated (manually or automatically), the following checks are performed
before resuming analyses on this new cassette:
1. New cassette (n+1) with a different lot number from the previous one (n)
The current calibration is disabled and a new calibration must be performed with the default
controls if configured in the application.
2. New cassette (n+1) with the same lot number as the previous one (n)
a. In case a calibration or a default control is ordered, pending or incomplete, then no check
described below is done and a new calibration must be performed with the default controls if
configured in the application.
b. If the Backup time frame without calibration required option is unselected in the application,
then the current calibration is disabled and a new calibration must be performed with the
default controls if configured in the application.
c. If the Backup time frame without calibration required option is selected in the application,
the following checks are performed:
■ If Activation date of cassette (n+1) - Installation date of cassette (n) > Back-up time frame,
then the current calibration is disabled and a new calibration must be performed with the
default controls if configured in the application.
■ If Activation date of cassette (n+1) - Installation date of cassette (n) ≤ Back-up time frame,
then the installation date of cassette (n+1) is checked.
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■ If Installation date of cassette (n+1) < Installation date of cassette (n), then the current
calibration is disabled and a new calibration must be performed with the default
■ If Installation date of cassette (n+1) ≥ Installation date of cassette (n), then the current
calibration stays valid and the default controls, if configured in the application, must be
performed.
■ If the Backup time frame without calibration required option is selected, it is

mandatory to configure at least one default control in the application.
■ Refer to the Settings > Application Configuration > Absorbance Applications >
Absorbance Applications Parameters > Calibration Parameters chapter to
configure the Backup time frame without calibration required option.
■ To Configure the Automatic Back-up Cassette Option, p.309
1.2.2. To Activate a Cassette
Follow this procedure to activate a cassette once it has been installed on the reagent tray.
Access: Main menu > Reagent Configuration > Configuration
When a new cassette is installed on the reagent tray, it is automatically activated unless a cassette of
the same solution is already active. In this case, you have to deactivate the active cassette before
activating the new cassette.
1. Select the Active current option to display only the active solutions currently configured on the
instrument.
2. Select the solution that you want to deactivate and press Details.
The Cassette screen is displayed.
3. Press Edit.
This function is unavailable if a calibration for this test is ordered, pending, incomplete or for
validation.
4. Select Inactive from the Reagent Status dropdown list.
6. Press Back to go back to the Configuration tab.
7. Select the Inactive current option to display only the inactive solutions currently configured on
the instrument.
8. Select the solution that you want to activate and press Details.
The Cassette screen is displayed.
9. Press Edit.
10. Select Active from the Reagent Status dropdown list.
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Settings
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■ Cassette Screen, p.221
1.3. Managing Reagents in an Open Cassette
The solutions in an open cassette are automatically configured in the Reagent Configuration menu
after installation on board.
However, they must be previously registered in Main menu > Services > Application Configuration
> Reagents and identified by barcode labels (PC400/P400 Open Cas. sticker sheet1 HAX0334
(1207230334) and PC400/P400 Open Cas. sticker sheet2 HAX0335 (1207230335)) provided by
HORIBA Medical.
The barcode label must match the reagent number previously registered.
1 = Barcode label
location
2 = 11.5 mm
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1.3.1. Open Cassette Screen
The Open Cassette screen displays the selected cassette (left side of the screen) and the selected
solution characteristics (right side of the screen).
Heading Description
ID Cassette barcode
Tray Sector Position number on the reagent tray
Analysis Method Number of reagents: Reagent 1 or Reagent 2
When a new open cassette has been installed on the reagent tray, it stays inactive. Therefore, it is
necessary to activate it before performing analyses on this new cassette.
Several open cassettes of the same solution cannot be installed on the reagent tray.
Empty open cassettes are automatically deactivated.
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1.3.2. To Activate an Open Cassette
Follow this procedure to activate an open cassette once it has been installed on the
reagent tray.
When a new open cassette has been installed on the reagent tray, it stays inactive. Therefore, it is
necessary to activate it before performing analyses on this new cassette.
the instrument.
The Open Cassette screen is displayed.
3. Press Edit.
4. Type the lot number (16 characters maximum).
1.3.3. To Change the Lot Number of a Reagent in an Open Cassette
Follow this procedure to change the lot number of a solution in an open cassette.
1. Select the solution and press Delete.

This function is unavailable if associated patient or control tests are ordered, pending, incomplete
or for validation.
A dialog box informs you that all associated calibrations (ordered, pending, incomplete, for
validation or validated) will be lost.
4. Replace the solution on the reagent tray using either a new open cassette (see step a) or the same
open cassette (see step b).
a. Replace the cassette by a new one previously identified by a barcode label matching the
reagent number previously registered in Main menu > Services > Application Configuration
> Reagents.
b. Clean the cassette with distilled water and dry it before refilling it with the new solution lot
number.
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The solution is automatically reconfigured in the Reagent Configuration menu.
5. Select the solution and press Details.

The Open Cassette screen is displayed.
6. Press Edit.
7. Type the new lot number (16 characters maximum).
After you changed the solution lot number, a new calibration must be performed with the default
1.3.4. To Delete an Open Cassette
Follow this procedure to delete an open cassette.

or for validation.
1.4. Managing Reagents on a Reagent Rack
The solutions on a reagent rack must be manually configured in the Reagent Configuration menu.
They must also be previously registered in the Main menu > Services > Application Configuration >
Reagents if they are not already pre-configured on the instrument.
■ To Add a Reagent on a Reagent Rack, p.229
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Settings
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1.4.1. Reagent Rack Screen
The Reagent Rack screen displays the selected rack (left side of the screen) and the selected
solution characteristics (right side of the screen).
Heading Description
ID Rack ID
Rack Sector Rack sector: A, B or C
Tray Sector First position number on the reagent tray
Analysis Method Number of reagents: Reagent 1, Reagent 2 or Reagent 3
When a new solution is configured on the reagent tray, it is automatically activated unless an identical
solution is already active.
Several identical solutions cannot be active simultaneously on the reagent tray. If several identical
solutions are configured on the reagent tray, then the first configured solution is active and the next
solutions are inactive.
Empty solutions are automatically deactivated.
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1.4.2. To Add a Reagent on a Reagent Rack
Follow this procedure to configure a solution on a reagent rack.
1. Press Add new.

The Reagent Rack screen is displayed.
2. Select a rack ID from the ID dropdown list.
3. Select an available rack sector from the Rack Sector dropdown list.
4. Choose the solution type from the Solution Type dropdown list.
■ Reagent
■ Diluent
■ Cleaner
5. Select the solution short name from the Reagent Solution Name dropdown list.
6. Type the lot number (16 characters maximum).
The solution is configured on the reagent tray, it is automatically activated unless an identical solution
is already active.
1.4.3. To Activate a Reagent on a Reagent Rack
Follow this procedure to activate a solution on a reagent rack once it is configured on the
reagent tray.
When a new solution is configured on the reagent tray, it is automatically activated unless an identical
solution is already active. In this case, you have to deactivate the active solution before activating the
new solution.
1. Select the Active current option to display only the active solutions currently configured on the
instrument.
2. Select the solution that you want to deactivate and press Details.
3. Press Edit.
4. Select Inactive from the Reagent Status dropdown list.
6. Press Back to go back to the Configuration tab.
the instrument.
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Reagent Management
9. Press Edit.
1.4.4. To Change the Lot Number of a Reagent on a Reagent Rack
Follow this procedure to change the lot number of a solution on a reagent rack.

or for validation.
4. Press Add new.
5. Reconfigure the solution with the new lot number (16 characters maximum).
After you changed the solution lot number, a new calibration must be performed with the default
1.4.5. To Delete a Reagent on a Reagent Rack
Follow this procedure to delete a solution on a reagent rack.

or for validation.
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Reagent Management

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Settings
Calibration and Control Configuration
2. Calibration and Control Configuration
2.1. Calibrators Configuration
Access: Main menu > Calibration/Control > Calibration
The Calibration tab lists the calibrators configured on the instrument. Calibrators are listed in a table
format which indicates the calibrator name, the rack position of calibrator, the calibrator lot number
and expiration date.
To configure a calibrator, three steps are needed:
■ Enter the calibrator characteristics,
■ Add the target values,
■ Configure the calibrator position.
■ To Enter the Calibrator Characteristics, p.232
■ To Add Target Values, p.233
■ To Configure the Calibrator Position, p.234
2.1.1. Adding a Calibrator
2.1.1.1. To Enter the Calibrator Characteristics
Follow this procedure to enter the calibrator name, lot number and expiration date.
1. Press Add new.

The Calibrator Selection screen is displayed.
2. Type the calibrator name (20 characters maximum), the lot number (16 characters maximum) and
the expiration date.
■ A single lot number can be configured and used on the instrument for a calibrator name.
■ The expiration date is not mandatory, however the instrument checks the calibrator expiration
date only if a valid date is entered.
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After you entered the calibrator characteristics, add the target values and configure the calibrator
position.
2.1.1.2. To Add Target Values
Follow this procedure to add the calibrator target values.
To add the calibrator target values, the calibrator characteristics must have already been entered.
Always ensure that the entered target values correspond to the calibrator name and lot
number used. Refer to the calibrator annex.
1. Select the calibrator and press Target values:
The target values list for the selected calibrator is displayed.

Target values are listed in a table format which indicates the calibrated test name, the target value
for each calibrator level and the test unit.
2. Press Add new.
The Target Values Entry screen is displayed.
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3. Select the test name from the Test dropdown list.

■ A test cannot be associated with several calibrators. Therefore, only the unassociated tests are
suggested in the dropdown list.
■ All tests associated with the same calibrator must have the same calibrator level number and
the same calibration pre-dilution configuration.
The application channel number and the test unit are displayed.
4. Enter either the main standard value or the target value for each calibrator level.
a. If the application features a calibration pre-dilution with Main direct or Main indirect dilution
type, type the main standard value.
The target value for each calibrator level is automatically calculated.
b. If the application does not feature a calibration pre-dilution or features a calibration pre-dilution
with Factor diluent dilution type, type the target value for each calibrator level in ascending or
descending order.
If the application features a calibration pre-dilution with Main direct or Main indirect
dilution type and a sample pre-dilution is programmed in the application, the calibrator
target values entered in the Target Values Entry screen have to be multiplied by the
pre-dilution factor. Example: If a sample pre-dilution with a pre-dilution factor of 21 is
programmed in the application and the calibrator target value mentions 2.22 g/L, the
value that must be entered is 2.22 * 21 = 46.62 g/L.
5. If you want to perform a recalibration with a single calibrator level, select the Standard Correction
option and choose the calibrator level from the spin box.
This function is unavailable if:
■ The calibration mode configured in the application is Factor or Slope average,
■ A calibration pre-dilution with Main direct or Main indirect dilution type is configured in the
application,
■ No calibration was previously performed for the test.
After you added the target values, configure the calibrator position.
2.1.1.3. To Configure the Calibrator Position
Follow this procedure to configure the calibrator position.
To configure the calibrator position, the calibrator characteristics and the target values must have
already been entered.
1. Select the calibrator and press Position.

The position selection screen is displayed.
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1 = Position on the rack

2 = Rack number
2. Press Edit.
This function is unavailable if associated tests are ordered, pending or incomplete.
3. Select the rack number by pressing the corresponding button (right side of the screen).
■ R-01 to R-29: calibrator reagent racks,
■ S-71 to S-84: calibrator sample racks,
■ B-41 to B-70: sample cup racks,
■ S-01 to S-40: sample racks.
The racks used on the instrument must be previously configured in the Main menu >
Services > System Configuration > Analyser.
The selected rack is displayed (left side of the screen). The status of each position is indicated by
a color code.
Available The position is available.
The position is occupied by an unknown sample but

Unknown
can be selected.
Occupied The position is occupied.
Calibrator The calibrator is configured on this position.
4. Select the position on the rack (left side of the screen).

As many positions as calibrator levels are needed, the positions must be one after the other on the
same rack.
■ If the calibrator has a single level, the selected position is assigned to the calibrator.
■ If the calibrator has several levels, the selected position is assigned to the first level and the
next positions are automatically assigned to the next levels.
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Settings
■ To Configure Racks, p.307
2.1.1.4. To Import the Calibrator Configuration
Follow this procedure to import the calibrator configuration (calibrator characteristics and
target values) provided by HORIBA Medical.
The calibrator configuration is provided by HORIBA Medical online at www.horiba.com for

the multi-parameters calibrators only.
1. Connect to the Web site: http://toolkits.horiba-abx.com/documentation/search.php.

2. Enter Clinical Chemistry > calibrator and control targets.
3. Choose the calibrator that you want to import.
4. Choose the lot number that you want to import and click the corresponding file in the Download
Target values column.
A dialog box asks you if you want to open or save the file.
5. Click Save and save the CiblesCalibrant.xml file in the root directory of a USB key.
Given that the .xml file has always the same name, you must import the calibrators one
by one.
6. On the Pentra C400, enter Main menu > Calibration/Control > Calibration.
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7. Press Import:

■ CD-ROM,
■ USB key.
instrument.
9. Select the support type and press OK to validate.

The calibrator name, the calibrator lot number and expiration date are displayed.
10. Press Edit.
This function is unavailable if calibrations are ordered, pending, incomplete or for validation.
The rules below apply when importing the calibrators.
■ If the calibrator to be imported does not exist on the instrument, the calibrator is imported.
■ If the calibrator to be imported already exists on the instrument with a different lot number, the
calibrator is imported and replaces the previous one.
■ If the calibrator to be imported already exists on the instrument with the same lot number, the
calibrator cannot be imported.
■ If the calibrator to be imported has expired, the calibrator cannot be imported.
■ Target values for a test are imported on condition that the application is configured on the
instrument and the target values comply with the application configuration.
■ A test cannot be associated with several calibrators. Therefore, if target values for a test are
already associated with another calibrator, the target values cannot be imported.
■ In case a current calibration exists for a test, a dialog box informs you that the calibration will
be lost.
■ After you imported the calibrator configuration (calibrator characteristics and target values),
configure the calibrator position.
■ After you modified the target values, a new calibration must be performed with the default controls
if configured in the application.
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2.1.2. Changing a Calibrator
2.1.2.1. To Modify the Calibrator Characteristics
Follow this procedure to modify the calibrator name, lot number and expiration date.
1. Select the calibrator and press Details.

2. Press Edit.
This function is unavailable if a test associated with this calibrator was requested.
3. Modify the calibrator name (20 characters maximum), the lot number (16 characters maximum)
and/or the expiration date.
■ A single lot number can be configured and used on the instrument for a calibrator name.
■ The expiration date is not mandatory, however the instrument checks the calibrator expiration
2.1.2.2. To Change the Calibrator Lot Number
Follow this procedure to change the calibrator lot number and expiration date.
1. Select the calibrator and press Duplicate.

This function is unavailable if associated tests are ordered, pending, incomplete or for validation.
2. Modify the lot number (16 characters maximum) and the expiration date.
After you changed the calibrator lot number, modify the target values.
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2.1.2.3. To Modify Target Values
Follow this procedure to modify the calibrator target values.
Always ensure that the entered target values correspond to the calibrator name and lot
number used. Refer to the calibrator annex.

Target values are listed in a table format which indicates the calibrated test name, the target value
for each calibrator level and the test unit.
2. Select the test and press Details.
3. Press Edit.
or for validation.
4. Modify either the main standard value or the target value for each calibrator level.
a. If the application features a calibration pre-dilution with Main direct or Main indirect dilution
type, type the main standard value.
The target value for each calibrator level is automatically calculated.
b. If the application does not feature a calibration pre-dilution or features a calibration pre-dilution
with Factor diluent dilution type, type the target value for each calibrator level in ascending or
descending order.
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If the application features a calibration pre-dilution with Main direct or Main indirect
dilution type and a sample pre-dilution is programmed in the application, the calibrator
target values entered in the Target Values Entry screen have to be multiplied by the
pre-dilution factor. Example: If a sample pre-dilution with a pre-dilution factor of 21 is
programmed in the application and the calibrator target value mentions 2.22 g/L, the
value that must be entered is 2.22 * 21 = 46.62 g/L.
5. If you want to perform a recalibration with a single calibrator level, select the Standard Correction
option and choose the calibrator level from the spin box.
This function is unavailable if:
■ The calibration mode configured in the application is Factor or Slope average,
■ A calibration pre-dilution with Main direct or Main indirect dilution type is configured in the
application,
■ No calibration was previously performed for the test.
If a calibration for this test is ordered, pending, incomplete or for validation or in case a current
calibration exists for this test, a dialog box informs you that the calibration will be lost.
After you modified the target values, a new calibration must be performed with the default controls if
2.1.2.4. To Delete Target Values
Follow this procedure to delete the calibrator target values.

2. Select the test and press Delete.
In case a current calibration exists for this test, a dialog box informs you that the calibration will be
lost.
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2.1.2.5. To Delete the Calibrator Position
Follow this procedure to delete the calibrator position.
1. Select the calibrator and press Position.

2. Press Delete to delete the calibrator position.
2.1.3. To Delete a Calibrator
Follow this procedure to delete a calibrator.
1. Select the calibrator and press Delete.

lost.
2.2. Controls Configuration
Access: Main menu > Calibration/Control > Control
The Control tab lists the controls configured on the instrument. Controls are listed in a table format
which indicates the control name, the rack position of control, the control lot number and expiration
date.
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Settings
To configure a control, three steps are needed:

■ Enter the control characteristics,
■ Add the target values,
■ Configure the control position.
■ To Enter the Control Characteristics, p.242
■ To Configure the Control Position, p.244
2.2.1. Adding a Control
2.2.1.1. To Enter the Control Characteristics
Follow this procedure to enter the control name, lot number and expiration date.
1. Press Add new.

The Control Selection screen is displayed.
2. Type the control name (20 characters maximum), the lot number (16 characters maximum) and the
expiration date.
■ A single lot number can be configured and used on the instrument for a control name.
■ The expiration date is not mandatory, however the instrument checks the control expiration
After you entered the control characteristics, add the target values and configure the control position.
2.2.1.2. To Add Target Values
Follow this procedure to add the control target values.
To add the control target values, the control characteristics must have already been entered.
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Always ensure that the entered target values correspond to the control name and lot
number used. Refer to the control annex.
1. Select the control and press Target values:
The target values list for the selected control is displayed.

Target values are listed in a table format which indicates the controlled test name, if the control is
a default control for this test, the test unit, the control target value and confidence range.
2. Press Add new.
3. Select the test name from the Test dropdown list.

The application channel number and the test unit are displayed.
4. Enter the control target value and confidence range.
5. To configure the control as a default control for this test, select the Default Control option.
The default controls already configured for the test are listed at the bottom of the screen.
After you added the target values, configure the control position.
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Settings
2.2.1.3. To Configure the Control Position
Follow this procedure to configure the control position.
To configure the control position, the control characteristics and the target values must already be
entered.
1. Select the control and press Position.

1 = Position on the rack

2 = Rack number
2. Press Edit.
This function is unavailable if associated tests are ordered, pending or incomplete.
3. Select the rack number by pressing the corresponding button (right side of the screen).
■ R-30 to R-59: control reagent racks,
■ S-85 to S-99: control sample racks,
■ B-41 to B-70: sample cup racks,
■ S-01 to S-40: sample racks.
The racks used on the instrument must be previously configured in the Main menu >
Services > System Configuration > Analyser.
The selected rack is displayed (left side of the screen). The status of each position is indicated by
a color code.
Available The position is available.
The position is occupied by an unknown sample but

Unknown
can be selected.
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Occupied The position is occupied.
Control The control is configured on this position.
4. Select the position on the rack (left side of the screen).

The selected position is assigned to the control.
2.2.1.4. To Import the Control Configuration
Follow this procedure to import the control configuration (control characteristics and
target values) provided by HORIBA Medical.
The control configuration is provided by HORIBA Medical online at www.horiba.com for

the multi-parameters controls only.
1. Connect to the Web site: http://toolkits.horiba-abx.com/documentation/search.php.

2. Enter Clinical Chemistry > calibrator and control targets.
3. Choose the control that you want to import.
4. Choose the lot number that you want to import and click the corresponding file in the Download
Target values column.
A dialog box asks you if you want to open or save the file.
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5. Click Save and save the CiblesControle.xml file in the root directory of a USB key.
Given that the .xml file has always the same name, you must import the controls one
by one.
6. On the Pentra C400, enter Main menu > Calibration/Control > Control.
7. Press Import:

■ CD-ROM,
■ USB key.
instrument.

The control name, the control lot number and expiration date are displayed.
10. Press Edit.
This function is unavailable if controls are ordered, pending, incomplete or for validation.
The rules below apply when importing the controls.
■ If the control to be imported does not exist on the instrument, the control is imported.
■ If the control to be imported already exists on the instrument with a different lot number, the
control is imported and replaces the previous one.
■ If the control to be imported already exists on the instrument with the same lot number, the
control cannot be imported.
■ If the control to be imported has expired, the control cannot be imported.
■ Target values for a test are imported on condition that the application is configured on the
instrument.
After you imported the control configuration (control characteristics and target values), configure the
control position.
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2.2.2. Changing a Control
2.2.2.1. To Modify the Control Characteristics
Follow this procedure to modify the control name, lot number and expiration date.
1. Select the control and press Details.

2. Press Edit.
This function is unavailable if a test associated with this control was requested.
3. Modify the control name (20 characters maximum), the lot number (16 characters maximum)
and/or the expiration date.
■ A single lot number can be configured and used on the instrument for a control name.
■ The expiration date is not mandatory, however the instrument checks the control expiration
2.2.2.2. To Change the Control Lot Number
Follow this procedure to change the control lot number and expiration date.
1. Select the control and press Duplicate.

2. Modify the lot number (16 characters maximum) and the expiration date.
The previous control lot number is closed.
After you changed the control lot number, modify the target values.
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2.2.2.3. To Modify Target Values
Follow this procedure to modify the control target values.
Always ensure that the entered target values correspond to the control name and lot
number used. Refer to the control annex.

Target values are listed in a table format which indicates the controlled test name, if the control is
a default control for this test, the test unit, the control target value and confidence range.
2. Select the test and press Details.
3. Press Edit.
4. Modify the control target value and confidence range.
5. To configure the control as a default control for this test, select the Default Control option.
The default controls already configured for the test are listed at the bottom of the screen.
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2.2.2.4. To Close Target Values
Follow this procedure to close the control target values.

2. Select the test and press Close control.
If the control was configured as a default control for this test, a new default control must be configured
for this test.
2.2.2.5. To Delete the Control Position
Follow this procedure to delete the control position.
1. Select the control and press Position.

2. Press Delete to delete the control position.
2.2.3. To Close a Control
Follow this procedure to close a control.
1. Select the control and press Close control.

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If the control was configured as a default control for one or several tests, a new default control must
be configured for these tests.
2.3. ISE Calibration Configuration (Option)
To operate correctly, the ISE module remains on, 24 hours a day, and is calibrated regularly whether
the Pentra C400 is operational or shut down.
ISE reagents running dry can damage the electrodes.

Ensure that there is always enough ISE reagents to perform the ISE module calibrations.
■ The 2-point calibration determines a slope and an intercept using the low and high standards (of
known concentrations). The determined slope and intercept are then used to calculate the
concentrations of patient samples.
The 2-point calibration should be performed every 2 hours whether the Pentra C400 is operational
or shut down.
■ The 1-point calibration checks the electrode stability and recalculates the intercept using the low
standard.
This calibration should be performed every 15 minutes only when the Pentra C400 is operational.
■ The Ready cycle ensures the electrode stability when the Pentra C400 is operational.
This cycle circulates low standard through the electrodes and should be performed every 5
minutes.
■ The Keep ready cycle ensures the electrode stability when the Pentra C400 is shut down.
This cycle circulates low standard through the electrodes and should be performed every 15
minutes.
The ISE module calibrations as well as the Ready and Keep ready cycles are configured
by default as mentioned above. To modify this configuration, refer to the ISE Calibration
Configuration > To Modify ISE Calibration Configuration chapter.
■ To Modify ISE Calibration Configuration, p.251
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2.3.1. To Modify ISE Calibration Configuration
The ISE module calibrations as well as the Ready and Keep ready cycles are configured
by default. Follow this procedure to modify the default configuration.
Access: Main menu > Calibration/Control > ISE Calibration
1. Press Edit.
2. To enable or to disable a calibration or a cycle, select or deselect the corresponding check box.
3. To change the frequency of a calibration or a cycle, press the up or down arrows from the
corresponding spin box.
Frequency
Parameter Configurable range Default value (recommended)
1-point calibration 5-480 min. 15 min.
2-point calibration 15-480 min. 120 min.
Keep ready 10-480 min. 15 min.
Ready 5-15 min. 5 min.
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3. Application Configuration
3.1. Application Configuration Overview
Access: Main menu > Services > Application Configuration > Applications
Many applications are provided by HORIBA Medical. These applications are maintained and updated
by HORIBA Medical with the Reagent Application media (USB flash drive).
Your local representative may also provide you with some applications.
The applications provided by HORIBA Medical or your local representative are configured on reserved
channels. Only a few parameters are modifiable in these applications.
User channels allow you to add your own applications. The number of user channels is limited and
configured by your local HORIBA Medical representative. All parameters are configurable and
modifiable in these applications.
The Applications tab lists the applications configured on the instrument.

You can select the applications to be displayed from the following options.
■ Resident: To display the applications provided by HORIBA Medical or your local representative.
■ Other: To display the user applications.
■ All: To display all the applications.
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The applications are listed in a table format which gives the following information.
Heading Description
Code Application short name.
Local Code Application short name defined by the user.
Enable If selected, the application is enabled and then selectable in the request
capture screen.
Unit Unit used to display the results.
Reference Range Low Low limit value of the Man/Default reference range
Reference Range High High limit value of the Man/Default reference range
Calibrator Used Name of the calibrator used for this test.
Contr. Required If selected, default controls are required to validate the calibration.
Up to three default controls can be configured.
Control Used Name of the default controls used for this test
Reagent Short Name Short name of the reagent used for this test.
Cassette If selected, the reagent is in a cassette.
Release Application version number.
Modified on Application modification date and time.
■ The version number of the last Reagent Application media installed on the instrument
is displayed in the Current revision field.
■ An item in gray means that the application was not updated during the last Reagent
Application media installation.
3.2. Absorbance Applications
3.2.1. Absorbance Applications Parameters
The absorbance applications configuration screen is divided into five tabs:

■ General Parameters
■ Calibration Parameters
■ Analysis Parameters
■ Calculation Parameters
■ Unit Parameters
For detailed information concerning the procedures to manage the absorbance

applications, refer to the Absorbance Applications > Managing Absorbance Applications
chapter.
■ Managing Absorbance Applications, p.272
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3.2.1.1. General Parameters
Access: Main menu > Services > Application Configuration > Applications > General Parameters
Application identification fields

Test Name Test name corresponding to the application. 15 characters maximum
Must be unique.
Code Application short name. 7 characters maximum
Must be unique.
Local code Application short name defined by the user. 7 characters maximum
Must be unique.
Channel Application channel number. From 1 to 999
Must be unique.
Enable If selected, the application is enabled and then Check box
selectable in the request capture screen.
Release Application version number. 4 numerical characters: nn.nn
Modified on Application modification date and time. Depending on the configured date
and time format
■ Channel: The channels from 1 to 800 are reserved for the applications provided by
HORIBA Medical. Your local representative may also provide you with some applications on the
channels from 801 to "800 + X" where X is the number of channels reserved for your local
representative. Depending on the number of user channels configured on your instrument, the
user channels are from "1000 - Y" to 999 where Y is the number of user channels configured on
your instrument. Example: If the number of channels reserved for your local representative is set to
10 and the number of user channels is set to 5, the channels from 801 to 810 ("800 + 10") are
reserved for your local representative and the user channels are from 995 ("1000 - 5") to 999.
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Characteristics

Sample Type Serum/Plasma, Urine or Other. Dropdown list
Number of Reagents Number of reagents: Reagent 1, Reagent 2 or -
Reagent 3
Updated when the reagent short name is
selected.
Reagent Short Name Short name of the reagent used for this test. Dropdown list
Reagent Number Reagent number. 3 numerical characters maximum
selected.
On Board Stability Reagent on board stability in days (only for From 0 to 365 days
(days) cassette).
This will be used to calculate the use limit date on
the Pentra C400.
Not to be configured by the user.
Cassette If selected, the reagent is in a cassette. Check box
selected.
■ Reagents must have been previously registered on the instrument.

■ For the applications provided by HORIBA Medical or your local representative, the reagents
are already registered on the instrument.
■ For the user applications, the reagents must have been previously registered in Main menu >
Services > Application Configuration > Reagents. Only the reagents registered by your local
representative or yourself are selectable in the Reagent Short Name dropdown list.
Pre-dilution

Pre-dilution If selected, patient samples and controls are pre- Check box
diluted.
Diluent Name Pre-dilution diluent Dropdown list
Factor Pre-dilution factor From 2.0 to 22500.0
Incubation time (in Incubation time of pre-diluted sample (in number From 1 to 99 cycles
cycles) of cycles)
■ Factor: If a pre-dilution is programmed, it follows the dilution procedure with FD = FPre-dil

If a post-dilution has to be configured, FPost-dil * FPre-dil must be ≤ 22500.0.
For detailed information concerning the dilution procedure, refer to the Description and
Technology > Sampling System > Dilutions Management chapter.
■ Incubation time (in cycles): For applications not linked to a ratio, this incubation time represents
the minimum time of delay between the dilution and its use in the analysis sequence.
For applications linked to a ratio, this time is fixed. The analysis sequence cycles and cleaning
cycles (if a needle cleaning is required) must be taken into account for the incubation time
configuration.
That is illustrated by the example below.
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Cycle # 1 2 3 4 5 6 7 8
R1 R2 + Sample
Incubation time
Sample
pre-dilution
Cycle 1: R1 is pipetted by the reagent needle.

Cycle 5: R2 and Sample are pipetted respectively by the reagent and sample needles.
If the programmed incubation time of the pre-diluted sample is 4, the pre-dilution must be
performed during cycle 1.
Cycle 1 is already used, so the pre-dilution cannot be performed. In that case, a dialog box
informs you that the incubation time of the pre-diluted sample and the analysis sequence cycles
are incompatible.
Result

Unit Unit used to display the results. Dropdown list
Decimal Position Decimal position used to display the results. From 0 to 5
Manual Patient If selected, all patient samples for this application Check box
Validation must be manually validated.
■ Unit: Units must be previously configured in Main menu > Services > Application Configuration
> Applications > Unit Parameters.
■ Manual Patient Validation: If unselected, only patient samples that are not automatically
validated must be manually validated. It then depends on the patients automatic validation
configured in Main menu > Services > System Configuration > Results Validation.
Correlation
The Correlation area allows the user to convert results in order to correlate them with an alternative
method or another temperature. This result correlation area is dedicated to the user.

Slope Slope (A) of the regression line y = A * x + B From 0.00001 to 99.99999
Default value: 1
Intercept Intercept (B) of the regression line y = A * x + B From -9999.99999 to 9999.99999
Default value: 0
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The intercept is always expressed in the reference unit. If an alternative unit is chosen to
display the results, it is necessary to make the following calculation before programming
the intercept: B = b / FU where:
■ B is the intercept to be programmed in the application,
■ b is the intercept to be applied to the final result,
■ FU is the unit conversion factor. The unit conversion factor is displayed in Main menu
> Services > Application Configuration > Applications > Unit Parameters.
For example, in an application the reference unit is g/L and the alternative unit mmol/L is
used. 1 g/L converts to 10 mmol/L, so in this example FU = 10. The user wishes to add an
intercept of 20 mmol/L to all results. In this case, B = b / FU = 20 / 10 = 2. 2 must be
programmed in the Intercept field.
Linearity

Linearity If selected, the linearity range check is enabled. Check box
Low Limit Low limit value of the linearity range 6 numerical characters maximum +
decimal position configured in the
application with 7 significant digits
maximum
High Limit High limit value of the linearity range 6 numerical characters maximum +
maximum
■ Linearity range check: The sample result is checked to ensure that it is within the programmed
linearity range. If not, the analytical flag LINEARITY_HIGH or LINEARITY_LOW is triggered and an
automatic rerun with post-dilution or post-concentration is performed if configured in the
application.
Automatic Rerun

Post Dilution If selected, the automatic rerun with post-dilution Check box
is enabled.
Dilution Factor Post-dilution factor From 2.0 to 22500.0
Post Concentration If selected, the automatic rerun with post- Check box
concentration is enabled.
Concentration Factor Post-concentration factor From 2.0 to 10.0
■ Post-dilution:
■ Post-dilution without pre-dilution configured:
If, at each analysis line where a "SAMPLE" pipetting is programmed, a H2O volume to push the
sample volume is programmed and SV ≥ FPost-dil * 2, then the dilution is performed in the
needle and no cuvette is used for dilution.
If one of the two conditions above is not met, then the dilution procedure applies with
FD = FPost-dil
■ Post-dilution with pre-dilution configured:
The dilution procedure applies with FD = FPost-dil * FPre-dil
FPost-dil * FPre-dil must be ≤ 22500.0.
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■ Post-concentration: An automatic rerun with post-concentration is programmable only if a pre-

dilution is configured or if, at each analysis line where a "SAMPLE" pipetting is programmed, a
H2O volume to push the sample volume is programmed.
■ Post-concentration with pre-dilution and without H2O volume configured:
One of the following conditions must be met:
■ FPost-conc ≤ FPre-dil / 1.2 or
■ FPost-conc = FPre-dil
FD = FPre-dil / FPost-conc
If FPost-conc ≤ FPre-dil / 1.2, then the dilution procedure applies with FD = FPre-dil / FPost-conc
If FPost-conc = FPre-dil then FD = 1 and no dilution is performed.
■ Post-concentration without pre-dilution and with H2O volume configured:
■ FPost-conc ≤ (SV + H2OV - 2) / SV or
■ FPost-conc = (SV + H2OV) / SV
FD = 1 / FPost-conc and the dilution (or concentration) is performed in the needle and no cuvette
is used for dilution.
■ Post-concentration with pre-dilution and with H2O volume configured:
■ FPost-conc ≤ FPre-dil * (SV + H2OV - 2) / SV and FPost-conc ≥ 2 * FPre-dil / SV or
■ FPost-conc = FPre-dil * (SV + H2OV) / SV or
■ FPost-conc ≤ FPre-dil / 1.2
FD = FPre-dil / FPost-conc
If FD < 1.2, then the dilution (or concentration) is performed in the needle and no cuvette is
used for dilution.
If FPost-conc ≤ FPre-dil / 1.2, then the dilution procedure applies with FD = FPre-dil / FPost-conc
Delta Check

Delta Check If selected, the delta check is enabled. Check box
Delta Check Validity Time in days which determines if the delta check From 0 to 999 days (depending on
must be performed. the number of results stored in the
database)
Absolute Variation Authorized absolute variation expressed in the 6 numerical characters maximum +
unit chosen to display the result. decimal position configured in the
maximum
Relative Variation Authorized relative variation (%) From 0.01 to 99.99%
■ Delta check: The delta check is used to check the variation between the current result and the
previous result to ensure that it is not higher than the authorized absolute and/or relative
variations. If it is, the delta check flag (D+ or D-) is triggered.
The delta check is performed only if:
Run date of the current result - Run date of the previous result ≤ Delta Check Validity
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where the previous result is a result for this test, previously run and validated, for the same patient
but for a different sample.
Reference Range

Low Check If selected, the low reference value check is Check box
enabled.
Man/Default Low limit value of the Man/Default reference 6 numerical characters maximum +
range decimal position configured in the
Woman Low limit value of the Woman reference range
maximum
Child (< 12 years) Low limit value of the Child reference range
High Check If selected, the high reference value check is Check box
enabled.
Man/Default High limit value of the Man/Default reference 6 numerical characters maximum +
Woman High limit value of the Woman reference range
maximum
Child (< 12 years) High limit value of the Child reference range
■ Low reference value check: The sample result is checked to ensure that it is not lower than the
low limit value of the reference range. If it is, the analytical flag REF_RANGE_LOW is triggered.
If the Low Check option is selected, at least the low limit value of the Man/Default reference range
must be programmed.
■ High reference value check: The sample result is checked to ensure that it is not higher than the
high limit value of the reference range. If it is, the analytical flag REF_RANGE_HIGH is triggered.
If the High Check option is selected, at least the high limit value of the Man/Default reference
range must be programmed.
Rerun Range

Low Check If selected, the low critical value check is enabled. Check box
Man/Default Low limit value of the Man/Default critical range 6 numerical characters maximum +
Woman Low limit value of the Woman critical range
Child (< 12 years) Low limit value of the Child critical range maximum
High Check If selected, the high critical value check is Check box
enabled.
Man/Default High limit value of the Man/Default critical range 6 numerical characters maximum +
Woman High limit value of the Woman critical range
Child (< 12 years) High limit value of the Child critical range maximum
■ Low critical value check: The sample result is checked to ensure that it is not lower than the low
limit value of the critical range. If it is, the analytical flag CRITICAL_LOW is triggered and the
sample is automatically rerun without post-concentration (a new test is requested).
If the Low Check option is selected, at least the low limit value of the Man/Default critical range
must be programmed.
■ High critical value check: The sample result is checked to ensure that it is not higher than the
high limit value of the critical range. If it is, the analytical flag CRITICAL_HIGH is triggered and the
sample is automatically rerun without post-dilution (a new test is requested).
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If the High Check option is selected, at least the high limit value of the Man/Default critical range
must be programmed.
■ Unit Parameters, p.271
■ Dilutions Management, p.459
3.2.1.2. Calibration Parameters
Access: Main menu > Services > Application Configuration > Applications > Calibration Parameters
Calibration

Calibration mode Factor, Slope average, Linear regression, Linear Dropdown list
interpolation, LOGIT/LOG4, LOGIT/LOG5 or
EXPONENT5
Level Number of calibrator levels. From 1 to 8
Restrictions apply depending on the calibration
mode chosen.
Calibration Factor Only available for Factor and Slope average 5 significant digits maximum
calibration modes. From 0.01 to 99999
■ Factor: Theoretical factor to be captured.
■ Slope average: Displays the calculated factor.
Not to be captured in this case.
Run(s) Number of runs. From 1 to 3
Dev_Rep (%) If selected, the deviation concerning replicates is Check box
checked.
Authorized Dev_Rep in % From 0.1 to 99.9%
Dev_C (%) If selected, the deviation to the curve is checked. Check box
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Authorized Dev_C in % From 0.1 to 99.9%
Calibrator Used Name of the calibrator used for this test. -
Displayed when previously configured in Main
menu > Calibration/Control > Calibration.
■ Calibration mode and Level: The calibration modes and the number of calibrator levels that they
require are described in the following table.
Calibration mode Description Calibrator level

number
Factor Theoretical factor which defines the relationship between the 0
measured absorbance change and the selected concentration
unit.
Slope average The factor is derived from a calibration. For linear calibration From 1 to 3
curves using from 1 to 3 standards.
Linear regression The curve parameters are derived from a linear regression. For From 2 to 8
linear calibration curves using from 2 to 8 standards.
Linear interpolation Linear interpolation from point to point. For non-linear From 3 to 8
calibration curves using from 3 to 8 standards.
LOGIT/LOG4 The curve parameters are derived from the four parameter From 4 to 8
logit/log algorithm. For non-linear calibration curves using
from 4 to 8 standards.
LOGIT/LOG5 The curve parameters are derived from the five parameter From 5 to 8
logit/log algorithm. For non-linear calibration curves using
EXPONENT5 The curve parameters are derived from the five parameter From 5 to 8
exponential algorithm. For non-linear calibration curves using
If the Factor calibration mode is selected:

■ The Level field and the Pre-dilution area are unavailable.
■ The calibration factor must be captured in the Calibration Factor field.
■ The number of runs is set to 1 and cannot be modified.
■ The reagent blank must be programmed in Main menu > Services > Application
Configuration > Applications > Analysis Parameters.
■ Dev_Rep (%) and Dev_C (%): Two types of deviation are checked.
■ Deviation concerning replicates (Dev_Rep): For each calibrator level, the absorbance values
of replicates are compared with the mean value. The maximum deviation is calculated
(Dev_Rep) and then checked to ensure that it is not higher than the authorized Dev_Rep. If it is,
the analytical flag DEVIATION is triggered.
■ Deviation to the curve (Dev_C): For each calibrator level, the concentration of the mean value
is compared with the theoretical value. The deviation is calculated (Dev_C) and then checked
to ensure that it is not higher than the authorized Dev_C. If it is, the analytical flag DEVIATION
is triggered.
Validity
The Validity area allows you to configure the calibration validity. Two options are available:
■ On Request: The current calibration is valid until a new calibration is requested.
■ Time Validity: The current calibration is valid for the defined period. When the defined period has
expired, the current calibration is disabled. As soon as a test for this application is requested, a
new calibration is automatically ordered.
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On Request If selected, the current calibration is valid until a Radio button
new calibration is requested.
Time Validity If selected, the current calibration is valid for the Radio button
defined period.
Interval Validity duration of the current calibration Depending on the chosen time unit:
■ From 0 to 23 hours
■ From 0 to 365 days
Time Unit Time unit: Hours or Days Dropdown list
Factor calibration
The Factor calibration area allows you to configure the calibration factor checks. These checks apply
to the calculated calibration factor and are only available for Slope average and Linear regression
calibration modes.

Low limit check If selected, the low limit check is enabled. Check box
Authorized low limit value 5 significant digits maximum
High limit check If selected, the high limit check is enabled. Check box
Authorized high limit value 5 significant digits maximum
Relative variation check If selected, the relative variation check is enabled. Check box
Authorized relative variation in % From 0.1 to 100.0%
■ Low limit check: The calculated calibration factor is checked to ensure that it is not lower than
the authorized low limit value. If it is, the analytical flag FACTOR_FLAG is triggered.
■ High limit check: The calculated calibration factor is checked to ensure that it is not higher than
the authorized high limit value. If it is, the analytical flag FACTOR_FLAG is triggered.
■ Relative variation check: The relative variation check consists in checking the variation between
the calculated calibration factor and the previous validated calibration factor to ensure that it is not
higher than the authorized relative variation. If it is, the analytical flag FACTOR_FLAG is triggered.
Control required

Control required If selected, default controls are required to Check box
validate the calibration.
Control 1 If selected, a first default control is required to Check box
Name of the first default control used for this test. -
menu > Calibration/Control > Control.
Control 2 If selected, a second default control is required to Check box
Name of the second default control used for this -
test.
Control 3 If selected, a third default control is required to Check box
Name of the third default control used for this -
test.
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■ If the Control required option is selected, the required default controls must be configured for this
test in Main menu > Calibration/Control > Control.
The default controls are automatically performed with the calibration. Ordered sample tests are not
carried out until the calibration and the default controls are validated.
To deselect the required default controls, the default controls configured for this test must be
previously disabled in Main menu > Calibration/Control > Control.
Validity Backup
The Validity Backup area allows you to configure a period during which the current calibration stays
valid when a new cassette, with the same lot number as the previous one, is activated (manually or
automatically). This period is called back-up time frame.

Backup time frame If selected, the backup time frame is taken into Check box
without calibration account when a new cassette, with the same lot
required number as the previous one, is activated
(manually or automatically).
Only available if the reagent is provided in a
cassette.
Interval Back-up time frame Depending on the chosen time unit:
■ From 0 to 23 hours
■ From 0 to 365 days
Time Unit Time unit: Hours or Days Dropdown list
If the Backup time frame without calibration required option is selected and when a new cassette
(n+1), with the same lot number as the previous one (n), is activated (manually or automatically), the
following checks are performed:
■ If Activation date of cassette (n+1) - Installation date of cassette (n) > Back-up time frame, then the
current calibration is disabled and a new calibration must be performed with the default controls if
■ If Activation date of cassette (n+1) - Installation date of cassette (n) ≤ Back-up time frame, then the
installation date of cassette (n+1) is checked.
■ If Installation date of cassette (n+1) < Installation date of cassette (n), then the current
calibration is disabled and a new calibration must be performed with the default controls if
■ If Installation date of cassette (n+1) ≥ Installation date of cassette (n), then the current
calibration stays valid and the default controls if configured in the application must be
performed.
■ If the Backup time frame without calibration required option is selected, it is

mandatory to configure at least one default control in the application.
■ Please note that the Backup time frame without calibration required option does
not work if the solution used has expired.
Pre-dilution

Pre-dilution If selected, calibrators are pre-diluted. Check box
Type Main direct, Main indirect or Factor diluent Dropdown list
Calibrator Diluent Pre-dilution diluent Dropdown list
Factor 1 to Factor 8 Dilution factors 0
1
From 2.0 to 150.0
■ Type: Three dilution types are available to pre-dilute calibrators.
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■ Main direct: The main standard is diluted in order to obtain a series of standards. Each dilution
is performed starting from the main standard. Dilution factors must be captured by the user.
■ Main indirect: The main standard is diluted in order to obtain a series of standards. Each
dilution is performed starting from the previous one. Dilution factors must be captured by the
user.
■ Factor diluent: This dilution type is only available if a sample pre-dilution has been configured
in the application. The series of standards is pre-diluted as patient samples and controls (with
the same dilution factor and incubation time). Factor fields are unavailable.
■ Factor 1 to Factor 8: For Main direct and Main indirect dilution types, dilution factors must be
captured by the user. The number of dilution factors to be captured equals the number of
calibrator levels configured in the application.
Factors are configured as follows:
■ 0: This means that no dilution has to be performed for this level, pure diluent is dispensed.
■ 1: This means that no dilution has to be performed for this level, pure main standard is
dispensed.
■ From 2.0 to 150.0: The corresponding dilution is performed with the configured dilution factor,
the associated concentration is calculated accordingly.
Using the Main direct dilution type, dilution factors must be captured in ascending or descending
order.
■ In ascending order, only the first factor can be equal to 1 and only the last factor can be equal
to 0.
■ In descending order, only the first factor can be equal to 0 and only the last factor can be equal
to 1.
Using the Main indirect dilution type, the only restrictions on dilution factors are that only the first
factor can be equal to 1 and only the last factor can be equal to 0.
Checks
The Checks area is only available if the reagent blank has been previously programmed in Main
menu > Services > Application Configuration > Applications > Analysis Parameters.

Reagent Limit If selected, the reagent range check is enabled. Check box
Absorbance Check
Reagent Range Low Low limit value of the reagent range From -3.00000 to 3.00000 OD
Reagent Range High High limit value of the reagent range From -3.00000 to 3.00000 OD
Reagent Blank Limit If selected, the blank range check is enabled. Check box
Absorbance Check
Blank Range - Low Low limit value of the blank range From -3.00000 to 3.00000 ΔOD
Limit
Blank Range - High High limit value of the blank range From -3.00000 to 3.00000 ΔOD
Limit
■ Reagent range check: All reagent blank absorbance values used for calculations are checked to
ensure that they are not out of the programmed reagent range. If they are, the analytical flag
REAG_RANGE_HIGH or REAG_RANGE_LOW is triggered.
■ Blank range check: The absorbance variation of the reagent blank is checked to ensure that it is
not out of the programmed blank range. If it is, the analytical flag BLK_RANGE is triggered.
■ Analysis Parameters, p.265
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3.2.1.3. Analysis Parameters
Access: Main menu > Services > Application Configuration > Applications > Analysis Parameters
Cleaner
The Cleaner area allows you to require a needle cleaning and to configure this cleaning.

Cleaner If selected, a needle cleaning is required. Check box
Cleaner Solution Cleaner name Dropdown list
Before If selected, the cleaning cycle is carried out Radio button
before the analysis sequence sampling.
After If selected, the cleaning cycle is carried out after Radio button
R1 has been dispensed.
H2O If selected, a cleaning cycle with distilled water is Check box
added.
■ If a needle cleaning is required, the cleaning cycles must be taken into account for the analysis
sequence cycles configuration. In addition, if a sample pre-dilution is programmed, the cleaning
cycles must also be taken into account for the incubation time configuration.
Wavelength

Primary Wavelength Wavelength used to measure the component Dropdown list
absorbance. From 340 nm to 700 nm
Secondary Wavelength Wavelength used to measure an absorbance due Dropdown list
to a cuvette defect, a variation of lamp intensity From 340 nm to 700 nm
or some sample interferences.
If configured, must be different from the primary
wavelength.
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Blank

Reagent Blank If selected, a reagent blank is performed with the Check box
calibration (one reagent blank regardless of the
number of calibration runs).
Diluent Diluent used for the reagent blank. Dropdown list
■ Reagent Blank: If unselected, the Checks area in Main menu > Services > Application
Configuration > Applications > Calibration Parameters is unavailable.
Analysis Sequence
Up to four analysis lines are programmed in the analysis sequence. Each analysis line is configured
with the following parameters.

Cycle Sampling cycle number From 1 to 99
Reagent Needle Solution pipetted by the reagent needle Dropdown list
Volume (µL) Volume pipetted by the reagent needle (µL) From 15.0 µL to 600.0 µL
Sample Needle Solution pipetted by the sample needle Dropdown list
Volume (µL) Volume pipetted by the sample needle (µL) From 2.0 µL to 95.0 µL
H2O Vol (µL) Distilled water volume pipetted by the sample 0 (zero)
needle (µL) to push the sample volume From 2.0 µL to 93.0 µL
■ Cycle: For the first analysis line, the cycle number is set to 1 and cannot be modified. For the
other analysis lines, the cycle numbers must be captured in ascending order.
If a needle cleaning is required, the cleaning cycles must be taken into account for the analysis
sequence cycles configuration. In addition, if a sample pre-dilution is programmed, the incubation
time of pre-diluted sample must also be taken into account for the analysis sequence cycles
configuration.
If a needle cleaning is required and the cleaning cycle is carried out after R1 has been
dispensed, then the cycle number following R1 dispensing must be:
■ ≥ R1 dispensing cycle number + 2, if one cleaning cycle is performed,
■ ≥ R1 dispensing cycle number + 3, if two cleaning cycles are performed.
■ Reagent Needle and Sample Needle: For the first analysis line, a solution must be selected from
the Reagent Needle dropdown list.
R1, R2 and/or R3 are pipetted once in the analysis sequence.
A solution cannot be pipetted twice in the same analysis line.
Moreover, if no sample is pipetted in the analysis sequence, sample pre-dilution, automatic rerun
and calibration pre-dilution must not be configured in the application.
■ Volume (µL) and H2O Vol (µL): For the first analysis line, the volume pipetted by the reagent
needle must be ≥ 95.0 µL.
For each analysis line, the total volume pipetted by the sample needle must be ≤ 95.0 µL.
A "SAMPLE" pipetting can be programmed at each analysis line. In this case, the total maximum
sample volume is 4 * 95.0 µL = 380 µL.
Depending on the configuration of sample pre-dilution, automatic rerun and calibration

pre-dilution in the application, restrictions apply on the maximum sample volume
pipetted in the analysis sequence. For more information on these restrictions, please
contact your local HORIBA Medical representative.
The addition of all volumes pipetted in the analysis sequence must be included between 150.0 and
600.0 µL.
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Mixing Speed

Mixing Speed Speed used to homogenize solutions into the From 1% to 100%
cuvette Default value: 40%
HORIBA Medical recommends not to use mixing speeds lower than 40%.
■ General Parameters, p.254
3.2.1.4. Calculation Parameters
Access: Main menu > Services > Application Configuration > Applications > Calculation Parameters
Correlation Factor
The Correlation Factor area allows the conversion of results in order to correlate them with an
alternative method or another temperature. This result correlation area is dedicated to
HORIBA Medical.

Default value: 1
Default value: 0
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Reaction Direction

Reaction Direction If selected, the reaction direction check is Check box
Check enabled.
Reaction Direction Expected reaction direction: Increase or Dropdown list
Decrease.
■ Reaction direction check: The reaction direction is checked to ensure that it corresponds to the
expected reaction direction. If not, the analytical flag SIGN is triggered.
Sample Limit Check

Sample Limit Check If selected, the sample limit check is enabled. Check box
Sample Limit (ΔO.D.) Sample limit value From -3.00000 to 3.00000 ΔO.D.
Sample Limit Cycle Cycle number for measuring the sample limit From 1 to 99
value.
Must be ≤ last reading cycle.
■ Sample limit check: The sample limit value is used to determine the sample-specific absorbance.
The reagent blank absorbance is subtracted from the sample absorbance, both measured at the
defined cycle. The calculated value is checked to ensure that it is not higher than the programmed
sample limit value. If it is, the analytical flag SAMPLE_LIMIT is triggered.
Antigen excess activation

Antigen excess If selected, the antigen excess check is enabled. Check box
activation
Antigen Excess Limit Antigen excess limit value From 0% to 100%
(%)
Antigen Excess Point Cycle number for the antigen excess check. From 0 to 99
Must be included between first reading cycle and
last reading cycle.
The antigen excess check is configurable only if the application answers to the three
following criteria:
■ One of the following calibration modes is used: Linear regression, Linear interpolation,
LOGIT/LOG4, LOGIT/LOG5 or EXPONENT5.
■ Only one calculation step is configured.
■ The Endpoint calculation type is used.
■ Antigen excess check: The antigen excess check is used to detect the presence of excess
antigen. The concentration measured at the defined cycle (CCP) is divided by the concentration
measured at the last reading cycle (C) and multiplied by 100. The calculated ratio is checked to
ensure that it is higher than the programmed antigen excess limit value. If not, the analytical flag
AG_EXCESS is triggered and an automatic rerun with post-dilution is performed if configured in
the application.
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■ If C = 0, then the analytical flag AG_EXCESS is triggered.

■ If CCP or C < 0, then the analytical flag AG_EXCESS is triggered.
■ If CCP is flagged with CALC_RANGE_HIGH or CALC_RANGE_LOW, then the antigen excess
check is not performed. The analytical flag CALC_RANGE_HIGH or CALC_RANGE_LOW is not
triggered (CCP).
■ If C is flagged with CALC_RANGE_HIGH or CALC_RANGE_LOW, then the antigen excess
check is not performed. The analytical flag CALC_RANGE_HIGH or CALC_RANGE_LOW is
triggered (C).
Please note that the concentrations used for this calculation do not take into account
the result correlations (user or HORIBA Medical) nor the unit conversion.
The areas Definition, Steps and Formula allow you to configure the reaction rate calculation.
■ The reaction can be divided in up to four calculation steps. The number of calculation steps is
defined in the Steps area.
■ For each calculation step, the step rate calculation is configured in the Definition area.
■ Then, the global reaction rate calculation is defined in the Formula area.
Steps
The Steps area allows you to define the number of calculation steps for the reaction rate calculation.

Step A Selected by default and not modifiable. The first Check box
calculation step is mandatory.
Step B If selected, a second calculation step is enabled. Check box
Step C If selected, a third calculation step is enabled. Check box
Step D If selected, a fourth calculation step is enabled. Check box
Definition
The Definition area is divided into four tabs: Step A, Step B, Step C and Step D. This allows you to
configure the step rate calculation for each calculation step according to the number of calculation
steps defined in the Steps area.

Calculation Type Endpoint, Kinetic or Kinsearch Dropdown list
Reaction Limit Check Only available for Kinetic and Kinsearch Check box
calculation types.
If selected, the reaction limit check is enabled.
Reaction Limit Reaction limit value From -3.00000 to 3.00000 ΔO.D.
Absorbance
Cycle Cycle number for measuring the reaction limit From 1 to 99
value.
Must be ≤ last reading cycle.
First Reading Cycle Cycle number corresponding to the first point From 0 to 99
used for calculation
Last Reading Cycle Cycle number corresponding to the last point From 1 to 99
used for calculation
■ Calculation Type: For detailed information concerning the calculation types, refer to the
Description and Technology > Data Analysis > Absorbance Measurements > Calculation Types
chapter.
■ Reaction limit check: The reaction limit value is used to determine substrate depletion. For the
Kinetic calculation type, the absorbance measured at the defined cycle is subtracted from the
absorbance value of the first reading point. For the Kinsearch calculation type, the absorbance
measured at the defined cycle is subtracted from the absorbance value of the first point within the
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linear range. The calculated value is checked to ensure that it is not higher than the programmed
reaction limit value. If it is, the analytical flag REAC_LIMIT is triggered and an automatic rerun with
post-dilution is performed if configured in the application.
■ First Reading Cycle: In order to read correctly, the volume into the cuvette must be greater than
150 µL.
■ If the total volume pipetted in the first analysis line is lower than 150 µL, then the first reading
cycle must be ≥ 2.
■ If the total volume pipetted in the first analysis line is greater than 150 µL but the volume
pipetted by the reagent needle is lower than 150 µL, then the first reading cycle must be ≥ 1.
■ If the volume pipetted by the reagent needle in the first analysis line is greater than 150 µL,
then the first reading cycle could be 0. This means that the first reading takes place after the
reagent needle dispensing and before the sample needle dispensing.
■ Last Reading Cycle: The last reading cycle should answer to the three following criteria:
■ last reading cycle > first reading cycle,
■ last reading cycle ≥ last cycle number of the analysis sequence,
■ for Kinetic and Kinsearch calculation types, last reading cycle - first reading cycle ≥ 4.
OD deviation check
The OD deviation check area allows you to configure the absorbance deviation checks. These
checks are performed during the reaction rate calculation in order to flag optical density jumps and
are configurable for each calculation step according to the number of calculation steps defined in the
Steps area.

Linear Regression Only available for Kinetic and Kinsearch Check box
calculation types.
If selected, the absorbance deviation check on
linear regression is enabled.
r2 threshold r2 threshold used for the absorbance deviation From 0.00 to 1.00
check on linear regression
SD SD threshold used for the absorbance deviation From 0.00000 to 1.00000
check on linear regression
First point Only available for the Endpoint calculation type. Check box
first point is enabled.
First point threshold First point threshold used for the absorbance From 0.00 to 1.00
deviation check on first point
Last point Only available for the Endpoint calculation type. Check box
last point is enabled.
SD Factor SD factor used for the absorbance deviation From 1 to 100
check on last point
■ Absorbance deviation check on linear regression: The correlation coefficient r2 and the
standard deviation SD are calculated. For the Kinetic calculation type, the measurement points
used to calculate r2 and SD are those included between the first reading cycle and the last reading
cycle. For the Kinsearch calculation type, the measurement points used to calculate r2 and SD are
those included in the linear range found with the linear search program. If r2 is lower than the
configured r2 threshold and SD is higher than the configured SD threshold, then the analytical flag
DIV_ABS is triggered.
■ Absorbance deviation check on first point: Two different algorithms can be used for this check:
one if the first reading cycle < 4, another if the first reading cycle ≥ 4.
■ If the first reading cycle < 4, a calculated absorbance difference is checked to ensure that it is
included in the configured blank range. If not, the analytical flag DIV_ABSi is triggered.
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The blank range must be programmed in Main menu > Services > Application
Configuration > Applications > Calibration Parameters.
■ If the first reading cycle ≥ 4, three calculated absorbance differences are checked to ensure
that they are lower than the configured threshold. If at least two absorbance differences are
greater than or equal to the configured threshold, the analytical flag DIV_ABSi is triggered.
The first point threshold is used and must then be configured only when the first
reading cycle ≥ 4.
■ Absorbance deviation check on last point: The difference between absorbance values at time n
and at time n-1 (where n = last reading cycle) is calculated and checked to ensure that it is
included in a calculated range. If not, the analytical flag DIV_ABSf is triggered.
This algorithm applies only when the last reading cycle is ≥ 11.
For detailed information concerning the absorbance deviation checks, refer to the
Description and Technology > Data Analysis > Absorbance Measurements > Calculation
Types > Absorbance Deviation Checks chapter.
Formula
The Formula area allows you to define the global reaction rate calculation when several calculation
steps are configured.
■ Absorbance Deviation Checks, p.473
3.2.1.5. Unit Parameters

Access: Main menu > Services > Application Configuration > Applications > Unit Parameters
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The Unit Parameters tab allows you to configure several units that can be used to display the results.
These units are then selectable from the Unit dropdown list (in Main menu > Services > Application
Configuration > Applications > General Parameters).
The first Unit and Conversion Factor fields correspond to the reference unit for this application. The
reference unit is mandatory and selectable from the Unit dropdown list. The conversion factor is set
to 1.000000 and cannot be modified.
The five other Unit and Conversion Factor fields correspond to the other units configured for this
application. Each unit is selectable from the Unit dropdown list and the conversion factor between the
reference unit and the chosen unit must be captured in the Conversion Factor field (from 10-6 to 107).
This multiplication factor is then used to display the results in the chosen unit.
For the applications provided by HORIBA Medical or your local representative, the reference unit and
up to five other units are configured and cannot be modified.
For the user applications, the reference unit and one other unit are programmable.
The table below lists the units that can be configured on the instrument.
mol/L g/L U/L kU/L

mol/dL g/dL U/dL kIU/L
mmol/L mg/L U/mL Unit
mmol/dL mg/dL mU/L µkat/L
µmol/L mg/mL mU/dL nkat/L
µmol/dL µg/L mU/mL mval/L
nmol/L µg/dL IU/L mEq/L
nmol/dL µg/mL IU/dL %
pmol/L ng/L IU/mL Δ%
pmol/dL ng/dL mIU/L s
g/mol ng/mL mIU/dL ΔA
mg/g pg/mL mIU/mL ΔA/min
3.2.2. Managing Absorbance Applications
3.2.2.1. To Add an Absorbance Application
Follow this procedure to add an absorbance application.
1. Press Add new.

This function is unavailable if all user channels are already configured or no reagent was registered
by your local representative or yourself.
The absorbance applications configuration screen is displayed.
2. Type the test name (15 characters maximum), the application code (7 characters maximum) and
the application local code (7 characters maximum).
The test name, the application code and the application local code must be unique.
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3. Configure the application parameters in the five tabs of the screen:

■ Unit Parameters
For detailed information concerning absorbance applications parameters, refer to the

Absorbance Applications > Absorbance Applications Parameters chapter.
3.2.2.2. To Duplicate an Absorbance Application
Follow this procedure to add an absorbance application by copying parameters of an

existing application.
1. Select the application of which you want to copy parameters and press Duplicate.
This function is unavailable if all user channels are already configured or no reagent was registered
by your local representative or yourself.
The absorbance applications configuration screen is displayed with the selected application
parameters.
2. Type the test name (15 characters maximum), the application code (7 characters maximum) and
the application local code (7 characters maximum).
The test name, the application code and the application local code must be unique.
3. Change the selected application parameters where necessary in the five tabs of the screen:
■ Unit Parameters

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3.2.2.3. To Modify an Absorbance Application
Follow this procedure to modify an absorbance application.
1. Select the application and press Details.

The absorbance applications configuration screen is displayed with the selected application
parameters.
2. Press Edit.
This function is also unavailable if the application is linked to a ratio. An application linked to a
ratio cannot be modified without deleting the ratio first.
3. Change the selected application parameters where necessary in the five tabs of the screen:
■ Unit Parameters

Only a few parameters are modifiable in the applications provided by HORIBA Medical or your
local representative. These parameters are called user parameters. For detailed information
concerning user parameters, refer to the Application Configuration > Updating the Applications >
Major, Minor and User Parameters chapter.
All parameters are modifiable in the user applications. However, the following restrictions apply:
■ The number of calibrator levels and the calibration pre-dilution (in Main menu > Services >
Application Configuration > Applications > Calibration Parameters) cannot be modified
without deleting the calibrator target values for this test first.
■ If the application is linked to a profile, the sample type (in Main menu > Services >
Application Configuration > Applications > General Parameters) cannot be modified
without deleting the profile first.
■ In case a current calibration exists for this test, the calibration will be lost if a major parameter
is modified. For detailed information concerning major parameters, refer to the Application
Configuration > Updating the Applications > Major, Minor and User Parameters chapter.
In case a current calibration exists for this test and if a major parameter was modified, a dialog box
informs you that the calibration will be lost.
■ Major, Minor and User Parameters, p.282
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3.2.2.4. To Delete an Absorbance Application
Follow this procedure to delete an absorbance application.
1. Select the application and press Delete.

This function is also unavailable for the applications provided by HORIBA Medical or your local
representative.
Moreover, the following conditions must be met to delete an application.
■ If the application is linked to a ratio or a profile, the ratio or the profile must be deleted first.
■ If calibrator or control target values are configured for this test, they must be deleted first.
■ The reagent used for this test must be deleted first from Reagent Configuration menu.
lost.
3.3. ISE Applications (Option)
3.3.1. ISE Applications Parameters
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Settings
For detailed information concerning the procedure to modify the ISE applications, refer to
the ISE Applications > To Modify an ISE Application chapter.

Test Name Test name corresponding to the application. 15 characters maximum
Must be unique.
Code Application short name. 7 characters maximum
Must be unique.
Local code Application short name defined by the user. 7 characters maximum
Must be unique.
Channel Application channel number. From 100 to 105
Must be unique.
Enable If selected, the application is enabled and then Check box
Release Application version number. 4 numerical characters: nn.nn
Modified on Application modification date and time. Depending on the configured date
and time format
Characteristics

Sample Type Serum/Plasma, Urine or Other. -
Result

Reference Unit Reference unit for this application Dropdown list
Decimal Position Decimal position used to display the results. From 0 to 5
Manual Patient If selected, all patient samples for this application Check box
Validation must be manually validated.
Conversion Factor Conversion factor between the reference unit and From 10-6 to 107
the chosen unit.
This multiplication factor is then used to display
the results in the chosen unit.
■ Manual Patient Validation: If unselected, only patient samples that are not automatically
validated must be manually validated. It then depends on the patients automatic validation
configured in Main menu > Services > System Configuration > Results Validation.
Correlation
The Correlation area allows the user to convert results in order to correlate them with an alternative
method or another temperature. This result correlation area is dedicated to the user.

Default value: 1
Default value: 0
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The intercept is always expressed in the reference unit. If an alternative unit is chosen to
display the results, it is necessary to make the following calculation before programming
the intercept: B = b / FU where:
■ B is the intercept to be programmed in the application,
■ b is the intercept to be applied to the final result,
■ FU is the unit conversion factor.
For example, in an application the reference unit is g/L and the alternative unit mmol/L is
used. 1 g/L converts to 10 mmol/L, so in this example FU = 10. The user wishes to add an
intercept of 20 mmol/L to all results. In this case, B = b / FU = 20 / 10 = 2. 2 must be
programmed in the Intercept field.
Reference Range

enabled.
maximum
enabled.
maximum
must be programmed.
Rerun Range

Woman Low limit value of the Woman critical range decimal position configured in the
enabled.
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Settings
must be programmed.
must be programmed.
Delta Check

Delta Check Validity Time in days which determines if the delta check From 0 to 999 days
must be performed.
maximum
Control required

Control required If selected, default controls are required to Check box
Control 1 If selected, a first default control is required to Check box
Name of the first default control used for this test. -
Control 2 If selected, a second default control is required to Check box
Name of the second default control used for this -
test.
Control 3 If selected, a third default control is required to Check box
Name of the third default control used for this -
test.
■ If the Control required option is selected, the required default controls must be configured for this
test in Main menu > Calibration/Control > Control.
Ordered sample tests are not carried out until the default controls are validated.
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To deselect the required default controls, the default controls configured for this test must be
previously disabled in Main menu > Calibration/Control > Control.
Linearity

Linearity If selected, the linearity range check is enabled. Check box
Low Limit Low limit value of the linearity range 6 numerical characters maximum +
maximum
High Limit High limit value of the linearity range 6 numerical characters maximum +
maximum
■ Linearity range check: The sample result is checked to ensure that it is within the programmed
linearity range. If not, the analytical flag LINEARITY_HIGH or LINEARITY_LOW is triggered.
■ To Modify an ISE Application, p.279
3.3.2. To Modify an ISE Application
Follow this procedure to modify an ISE application.
1. Select the application and press Details.

The ISE applications configuration screen is displayed with the selected application parameters.
2. Press Edit.
3. Change the selected application parameters where necessary.
For detailed information concerning ISE applications parameters, refer to the ISE
Applications > ISE Applications Parameters chapter.
Only a few parameters are modifiable in the ISE applications (provided by HORIBA Medical).
These parameters are called user parameters. For detailed information concerning user
parameters, refer to the Application Configuration > Updating the Applications > Major, Minor and
User Parameters chapter.
■ ISE Applications Parameters, p.275
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Settings
3.4. To Configure the Applications Order
Follow this procedure to configure the applications order, which is then used to display
the tests in the request capture screen, in the result validation screen and to print patient
results.
1. Press Order.
The applications order configuration screen is displayed.
2. Select the applications to be displayed from the following options.
■ Serum/Plasma: To display the applications which sample type is Serum/Plasma.
■ Urine: To display the applications which sample type is Urine.
■ Other: To display the applications which sample type is Other.
3. Press Edit.
4. To modify the applications order:
a. Select an application.
b. Press Up to move the application up or press Down to move the application down.
c. Repeat steps a and b for each application.
When a new application is configured on the instrument, this one takes the last
position in the applications order.
3.5. Updating the Applications
3.5.1. To Update the Applications
Follow this procedure to update the applications provided by HORIBA Medical on your
instrument.
1. Press Import:
This function is unavailable if tests are ordered, pending, incomplete or for validation.
■ CD-ROM,
■ USB key.
2. Install your support on the instrument.
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The applications update screen is displayed.
The applications for which an update is available on your support are listed in two tables: one for
major parameter updates, another for minor parameter updates.
■ When a major parameter is updated in an application, the current calibration for this test is lost.
A new calibration must be performed. If the number of calibrator levels or the calibration pre-
dilution is modified, the calibrator target values for this test are also deleted and must be
reconfigured.
■ When a minor parameter is updated in an application, the current calibration for this test is
kept in memory. A new calibration is not required.
For detailed information concerning major and minor parameters, refer to the Updating the
Applications > Major, Minor and User Parameters chapter.
Each table indicates the application code, the current application version number and modification
date and time, the update application version number, if the application is selected to be updated.
4. Press Edit.
5. By default, all applications are selected to be updated. If necessary, deselect the applications that
should not be updated.
If an application is already present on the instrument with the same test name, the
same application code or the same application local code but a different channel
number, then the application is unselected by default and cannot be updated. The
following message is displayed: At least one application has the same name or code
with different channel in the media. In this case, the test name, the application code or
the application local code must be modified before updating this application.
The restrictions below apply when updating the applications.
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■ If an application is linked to a ratio and the parameters modified in this application are
incompatible with the ratio, then the application cannot be updated. In this case, the ratio must
be deleted before updating the applications.
■ If an application is linked to a profile and the sample type is modified in this application, then
the application cannot be updated. In this case, the profile must be deleted before updating
the applications.
■ If a reagent is already present on the instrument with the same reagent short name but a
different reagent number, then the reagent cannot be updated. In this case, the reagent short
name must be modified before updating the applications.
■ If the container type is changed for a solution having a reagent number between 600 and 799,
a dialog box informs you that the solution will be deleted from the Reagent Configuration
menu.
■ Press OK to validate. In this case, after the applications update, you will have to
reconfigure the container type in Main menu > Services > Application Configuration >
Reagents and the solution in Reagent Configuration menu.
■ Press Cancel to cancel the applications update.
■ When an update of the reagent online help is available on your support and at least one
application is unselected, a dialog box informs you that the whole reagent online help is going
to be updated whereas at least one application will not be updated.
■ Press OK to validate.
■ Press Cancel to cancel the applications update.
The selected applications are updated as well as:
■ the reagents used in these applications,
■ all diluents and cleaners,
■ the incompatibilities related to these applications and configured by HORIBA Medical,
■ the reagent online help (when an update is available on your support).
It takes a few minutes.
User parameters are never affected when the applications are updated. For detailed information
concerning user parameters, refer to the Updating the Applications > Major, Minor and User
Parameters chapter.
A dialog box informs you when the update is completed.
7. Press OK.
■ To Modify an Absorbance Application, p.274
■ To Delete a Ratio, p.289
■ To Delete a Profile, p.293
■ To Modify a Reagent, p.299
3.5.2. Major, Minor and User Parameters
Applications parameters are divided into three categories:

■ Major parameters: When a major parameter is modified in an application, the current calibration
for this test is lost. A new calibration must be performed. If the number of calibrator levels or the
calibration pre-dilution is modified, the calibrator target values for this test are also deleted and
must be reconfigured.
■ Minor parameters: When a minor parameter is modified in an application, the current calibration
for this test is kept in memory. A new calibration is not required.
■ User parameters: Only a few parameters are modifiable in the applications provided by
HORIBA Medical or your local representative. These parameters are called user parameters. User
parameters are never affected when the applications are updated.
The table below indicates for each application parameter if this is a major, minor or user parameter.
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Parameter or Area Type

Test Name Major
Code Major
Local code User
Channel Minor
Enable User
Release Minor
Modified on User
Characteristics
Sample Type Minor
Number of Reagents Major
Reagent Short Name Major
Reagent Number Major
On Board Stability (days) Minor
Cassette Major for solutions having a reagent
number between 1 and 599.
User for solutions having a reagent
number between 600 and 799.
Pre-dilution (patient samples and controls) Major
Result User
Correlation (user) User
Linearity Minor
Automatic Rerun Minor
Delta Check User
Reference Range User
Rerun Range User
Calibration
Calibration mode Major
Level Major
Calibration Factor Minor
Run(s) Major
Dev_Rep (%) Major
Dev_C (%) Major
Validity Minor
Factor calibration Minor
Control required User
Validity Backup
Backup time frame without calibration required User
Interval Minor
Time Unit Minor
Pre-dilution (calibrators) Major
Checks Major
Cleaner Major
Wavelength Major
Blank Major
Analysis Sequence Major
Mixing Speed Major
Correlation Factor (HORIBA Medical) Major
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Parameter or Area Type

Reaction Direction Major
Sample Limit Check Minor
Antigen excess activation Minor
Steps Major
Definition
Calculation Type Major
Reaction Limit Check Minor
Reaction Limit Absorbance Minor
Cycle Minor
First Reading Cycle Major
Last Reading Cycle Major
OD deviation check Minor
Formula Major
Unit Parameters Minor
3.6. Ratios
Access: Main menu > Services > Application Configuration > Ratio
The Ratio tab lists the ratios configured on the instrument. Ratios are listed in a table format which
gives the following information.
Heading Description
Ratio name Ratio name
Enable If selected, the ratio is enabled and then selectable in the request capture
screen.
Unit Unit used to display the results.
Reference Range Low Low limit value of the Man/Default reference range
Reference Range High High limit value of the Man/Default reference range
Test A Name of the test A used in the ratio.
Test B If enabled, name of the test B used in the ratio.
Test C If enabled, name of the test C used in the ratio.
Test D If enabled, name of the test D used in the ratio.
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3.6.1. Ratio Parameters
For detailed information concerning the procedures to manage the ratios, refer to the
Ratios > Managing Ratios chapter.
Definition

Ratio name Ratio name. 7 characters maximum
Must be unique and different from test names
and application short names configured on the
instrument.
Ratio Ratio channel number. From 1000 to 1200
Must be unique.
Enable If selected, the ratio is enabled and then Check box
Sample Type Serum/Plasma, Urine or Other. Dropdown list
Test A Selected by default and not modifiable. The test Check box
A is mandatory.
Name of the test A used in the ratio. Dropdown list
Test B If selected, the test B is enabled. Check box
Name of the test B used in the ratio. Dropdown list
Test C If selected, the test C is enabled. Check box
Name of the test C used in the ratio. Dropdown list
Test D If selected, the test D is enabled. Check box
Name of the test D used in the ratio. Dropdown list
■ Enable: If one of the applications used in the ratio is disabled, then the ratio is automatically
disabled.
■ Sample Type: The applications used in a same ratio must have the same sample type configured.
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Formula
The Formula area allows you to define the ratio calculation with the tests enabled.
Result

Reference Unit Reference unit for this ratio Dropdown list
Decimal Number Decimal position used to display the results. From 0 to 5
Conversion Factor Conversion factor between the reference unit and From 10-6 to 107
the chosen unit.
This multiplication factor is then used to display
the results in the chosen unit.
Reference Range

enabled.
maximum
enabled.
maximum
must be programmed.
Rerun Range

Woman Low limit value of the Woman critical range decimal position configured in the
enabled.
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must be programmed.
must be programmed.
Delta Check

Delta Check Validity Time in days which determines if the delta check From 0 to 999 days
must be performed.
maximum
■ Managing Ratios, p.287
3.6.2. Managing Ratios
3.6.2.1. To Add a Ratio
Follow this procedure to add a ratio.
1. Press Add new.

The ratios configuration screen is displayed.
2. Type the ratio name (7 characters maximum).
The ratio name must be unique and different from test names, application codes and application
local codes configured on the instrument.
3. Enter the ratio channel number.
The ratio channel number must be unique.
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4. Configure the ratio parameters.
For detailed information concerning ratios parameters, refer to the Ratios > Ratio
Parameters chapter.
When validating the ratio, a check is performed on the cycles involved in pre-dilutions
of all the applications used in the ratio. A dialog box informs you if the pre-dilution
cycles are incompatible. For detailed information on pre-dilution cycles, refer to the
Application Configuration > Absorbance Applications > Absorbance Applications
Parameters > General Parameters chapter.
■ Ratio Parameters, p.285
3.6.2.2. To Duplicate a Ratio
Follow this procedure to add a ratio by copying parameters of an existing ratio.
1. Select the ratio of which you want to copy parameters and press Duplicate.
The ratios configuration screen is displayed with the selected ratio parameters.
2. Type the ratio name (7 characters maximum).
3. Enter the ratio channel number.
4. Change the selected ratio parameters where necessary.
Parameters chapter.
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3.6.2.3. To Modify a Ratio
Follow this procedure to modify a ratio.
1. Select the ratio and press Details.

The ratios configuration screen is displayed with the selected ratio parameters.
2. Press Edit.
3. Change the selected ratio parameters where necessary.
If the ratio was requested, the sample type and the tests used in the ratio cannot be modified.
Parameters chapter.
3.6.2.4. To Delete a Ratio
Follow this procedure to delete a ratio.
1. Select the ratio and press Delete.

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3.6.2.5. To Add a Sub-Ratio
Follow this procedure to add, in an existing ratio, a secondary ratio calculation using the
same tests than the main ratio. This avoids creating another main ratio with the same tests
and therefore this avoids running the same tests twice.
The main ratio is saved and is not being modified.

The sub-ratio is not already created. Only one sub-ratio can be configured.
1. Select the main ratio and press Details.

2. Press Add new from the Formula area.
A new tab is created to define the secondary ratio calculation.
3. Type the sub-ratio name (7 characters maximum).
4. Enter the sub-ratio channel number.
5. Define the secondary ratio calculation from the Formula area.
You cannot use other tests than those selected in the main ratio. However, you do not need to use
all of them in the calculation.
This means that you have to select all the tests needed for both calculations in the main ratio. And
also that you can define two calculations which do not use all the tests.
6. Configure the sub-ratio parameters.
Parameters chapter.
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The sub-ratio is created but it is neither displayed in the Ratio tab nor selectable in the request
capture screen. Only the main ratio is displayed and selectable.
3.6.2.6. To Modify a Sub-Ratio

2. Press the sub-ratio tab and press Edit.
3. Change the sub-ratio parameters where necessary.
Parameters chapter.
3.6.2.7. To Delete a Sub-Ratio
The sub-ratio is saved and is not being modified.

2. Press the sub-ratio tab and press Delete from the Formula area.
3.7. Profiles
Access: Main menu > Services > Application Configuration > Profiles
The Profiles tab lists the profiles configured on the instrument. Profiles are listed in a table format
which indicates the profile name and the profile sample type.
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Settings
3.7.1. To Add a Profile
Follow this procedure to add a profile.
1. Press Add new.

The profiles configuration screen is displayed.
2. Type the profile name (15 characters maximum).
The profile name must be unique.
3. Select the sample type from the following options.
■ Serum/Plasma: To display the applications for which the sample type is Serum/Plasma.
■ Urine: To display the applications for which the sample type is Urine.
■ Other: To display the applications for which the sample type is Other.
The applications included in a same profile must have the same sample type
configured.
The applications having the selected sample type are displayed.
4. Select the applications that you want to include in the profile.

3.7.2. To Modify a Profile
Follow this procedure to modify a profile.
1. Select the profile and press Details.

The profiles configuration screen is displayed.
2. Press Edit.
3. Select the applications that you want to add in the profile or deselect the applications that you
want to remove from the profile.
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3.7.3. To Delete a Profile
Follow this procedure to delete a profile.
1. Select the profile and press Delete.

3.8. Incompatibilities
Access: Main menu > Services > Application Configuration > Incompatibility
Test samplings are said to be incompatible when they can pose contamination problems if they are
performed one after the other.
A test sampling is defined by the application local code and the solution pipetted. To configure an
incompatibility, a first and a second test sampling must be specified in the order in which they must
not be performed. The following restrictions apply:
■ An incompatibility must be unique.
■ Both applications must be different.
■ Both applications must not be used in a same ratio.
■ ISE applications having the same sample type cannot configure an incompatibility.
The configured incompatibilities are taken into account when the instrument performs samplings.
Samplings are organized in order to avoid performing incompatible test samplings one after the other.
In case of incompatibility, the instrument inserts by order of priority a compatible test sampling or a
cleaning between both incompatible test samplings.
In case the cleaning is not performed, the second test sampling is not carried out and the test is
flagged with the sampling alarm relative to the cleaning failure. If both tests are already in progress,
the second test is flagged with I (INCOMPATIBILITY).
Incompatibilities are either configured by HORIBA Medical or added by the user. Those configured by
HORIBA Medical are maintained and updated at the same time as the applications by
HORIBA Medical with the Reagent Application media (refer to the Application Configuration >
Updating the Applications > To Update the Applications chapter).
The Incompatibility tab lists the incompatibilities configured on the instrument. Incompatibilities are
listed in a table format which gives the following information.
Heading Description
Needle Type Needle that performs both incompatible test samplings.
Reagent Needle or Sample Needle.
Code 1 Application local code of the first test sampling
Sampling Type 1 Solution pipetted of the first test sampling
Code 2 Application local code of the second test sampling
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Settings
Heading Description
Sampling Type 2 Solution pipetted of the second test sampling
Cleaner Cleaner used when the instrument inserts a cleaning between both
incompatible test samplings.
An item in red means that the incompatibility is disabled.
■ To Update the Applications, p.280
3.8.1. Incompatibility Parameters
For detailed information concerning the procedures to manage the incompatibilities, refer
to the Incompatibilities > Managing Incompatibilities chapter.
Needle Type and Active

Needle Type Needle that performs both incompatible test Dropdown list
samplings.
Reagent Needle or Sample Needle.
Active If selected, the incompatibility is enabled and Check box
then taken into account when the instrument
performs samplings.
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A test sampling is defined by the application local code and the solution pipetted. To configure an
incompatibility, a first and a second test sampling must be specified in the order in which they must
not be performed. The following restrictions apply:
■ An incompatibility must be unique.
■ Both applications must be different.
■ Both applications must not be used in a same ratio.
■ ISE applications having the same sample type cannot configure an incompatibility.
First Sequence Incompatibility

Abreviation Application local code of the first test sampling Dropdown list
Sampling Solution pipetted of the first test sampling Dropdown list
Following Sequence Incompatibility

Abreviation Application local code of the second test Dropdown list
sampling
Sampling Solution pipetted of the second test sampling Dropdown list
Cleaner
The Cleaner dropdown list allows you to configure which cleaner is used when the instrument inserts
a cleaning procedure between both incompatible test samplings.
■ Managing Incompatibilities, p.295
3.8.2. Managing Incompatibilities
3.8.2.1. To Add an Incompatibility
Follow this procedure to add an incompatibility.
1. Press Add new.

The incompatibilities configuration screen is displayed.
2. Configure the incompatibility parameters.
For detailed information concerning incompatibility parameters, refer to the

Incompatibilities > Incompatibility Parameters chapter.
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Settings
■ Incompatibility Parameters, p.294
3.8.2.2. To Modify an Incompatibility
Follow this procedure to modify an incompatibility.
1. Select the incompatibility and press Details.

The incompatibilities configuration screen is displayed with the selected incompatibility
parameters.
2. Press Edit.
This function is unavailable for the incompatibilities configured by HORIBA Medical.
3. Change the selected incompatibility parameters where necessary.
For detailed information concerning incompatibility parameters, refer to the

Incompatibilities > Incompatibility Parameters chapter.
■ Incompatibility Parameters, p.294
3.8.2.3. To Delete an Incompatibility
Follow this procedure to delete an incompatibility.
1. Select the incompatibility and press Delete.

This function is unavailable for the incompatibilities configured by HORIBA Medical.
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3.9. Reagents
Access: Main menu > Services > Application Configuration > Reagents
Any reagent to be used on the Pentra C400 must be previously registered on the instrument.
HORIBA Medical provides a full range of reagents. These reagents are already pre-configured on the
instrument.
Your local representative may also provide you with some reagents and register them on your
instrument.
The Reagents tab allows you to add your own reagents.
The Reagents tab lists the solutions registered on the instrument. Solutions are listed in a table
format which gives the following information.
Heading Description
Reagent Short Name Solution short name
Reagent # Reagent number.
Solution type Solution type: Reagent, Diluent or Cleaner
Solution information Solution information: Deproteinization or Etching solution (only for cleaner).
On Board Stability Reagent on board stability in days (only for cassette).
Number of Reagents Number of reagents: Reagent 1, Reagent 2 or Reagent 3
Cassette If selected, the reagent is in a cassette.
Dead volume Dead volume used to calculate the solution initial volume into the cassette
(only for cassette).
Sensibility Sensitivity level used for the reagent level detection.
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Settings
3.9.1. Reagent Parameters
For detailed information concerning the procedures to manage the reagents, refer to the
Reagents > Managing Reagents chapter.

Reagent Short Name Solution short name 7 characters maximum
Must be unique.
Reagent # Reagent number. From 1 to 999
Must be unique.
Solution Type Solution type: Reagent 1, Reagent 2, Reagent 3, Dropdown list
Diluent, Cleaner, Deproteinization or Etching
solution
Rack If selected, the reagent is on a reagent rack. Radio button
Cassette If selected, the reagent is in a cassette. Radio button
Sensibility Sensitivity level used for the reagent level Dropdown list
detection.
Only for solutions having a reagent number
between 600 and 799.
Not to be configured by the user.
■ Reagent #: The reagent numbers from 1 to 799 are reserved for the reagents provided by
HORIBA Medical. These reagents are already pre-configured on the instrument. The reagent
numbers from 800 to 999 can be used to register new reagents on the instrument.
■ Managing Reagents, p.299
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3.9.2. Managing Reagents
3.9.2.1. To Register a Reagent
Follow this procedure to register a new reagent on the instrument.
1. Press Add new.

This function is unavailable if all reagent numbers are already used.
The solutions configuration screen is displayed.
2. Type the reagent short name (7 characters maximum).
The reagent short name must be unique.
3. Enter the reagent number (from 800 to 999, starting by default on 901).
You must use a reagent number which is not already used.
4. Select the number of reagents from the Solution Type dropdown list.
5. Select the container type from the following options.
■ Rack: If selected, the reagent is on a reagent rack.
■ Cassette: If selected, the reagent is in an open cassette.
The Cassette option cannot be selected if the number of reagents is Reagent 3.
After you registered a new reagent, configure this reagent in the Reagent Configuration menu.
■ If the reagent is on a reagent rack, refer to the Reagent Management > Managing Reagents on a
Reagent Rack > To Add a Reagent on a Reagent Rack chapter.
■ If the reagent is in an open cassette, refer to the Reagent Management > Managing Reagents in an
Open Cassette chapter.
■ Managing Reagents in an Open Cassette, p.224
■ To Add a Reagent on a Reagent Rack, p.229
3.9.2.2. To Modify a Reagent
Follow this procedure to modify a solution previously registered on the instrument.
1. Select the solution and press Details.

The solutions configuration screen is displayed with the selected solution parameters.
2. Press Edit.
This function is unavailable if tests are ordered, pending, incomplete or for validation.
The solutions registered by HORIBA Medical are modifiable only if:
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■ they have a reagent number included between 600 and 799;

■ their solution type is different from Reagent 3.
3. Change the selected solution parameters where necessary.
■ If the solution was registered by HORIBA Medical, the reagent short name and the
solution type cannot be modified.
■ If the solution is programmed in an application or an incompatibility, the solution
type cannot be modified.
■ If the solution type is Reagent 3, the container type cannot be modified.
■ The reagent number and the sensitivity are never modifiable.
For detailed information concerning reagents parameters, refer to the Reagents >
Reagent Parameters chapter.
If you changed the container type, a dialog box informs you that all associated calibrations
(ordered, pending, incomplete, for validation or validated) will be lost. In addition, the solution will
be deleted from the Reagent Configuration menu.
If you changed the container type, the solution must be reconfigured in the Reagent Configuration
menu and a new calibration must be performed with the default controls if configured in the
application.
■ Reagent Parameters, p.298
3.9.2.3. To Delete a Reagent
Follow this procedure to delete a reagent.
1. Select the reagent and press Delete.

This function is unavailable if the solution was registered by HORIBA Medical or if the reagent is
programmed in an application or an incompatibility.
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4. System Configuration
Only available for administrators (Admin) or technicians (Tech).
4.1. Analyser
■ Configure the sample identification mode.

■ Enter the instrument serial number.
■ Enable or disable the sample and reagent level detections.
■ Enable or disable the cuvette changer.
■ Enable or disable the pressure detection of sample and reagent needles.
■ Enable or disable the sample and reagent barcode readers.
■ Configure automatic startup.
■ Configure automatic standby mode.
■ Configure automatic cleanings.
■ Configure the racks used on the instrument.
■ Enable or disable the ISE module.
■ Activate or deactivate an electrode.
■ Enable or disable the automatic back-up cassette option.
■ Enable or disable the cooling unit.
■ Configure the time lapse for displaying calibrations that will expire.
■ Enable or disable the automatic export of results to a USB key.
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4.1.1. To Configure Loading Mode
Follow this procedure to configure the sample identification mode according to your
laboratory working method.
This parameter cannot be modified if tests are ordered, pending, incomplete or for validation.
1. Press Edit.
2. Select the sample identification mode from the Loading Mode dropdown list.
■ Identification: Select this mode if all tubes are identified by barcode (default option).
■ Position: Select this mode if tubes without barcode are used on the instrument.
4.1.2. To Enter the Instrument Serial Number
Follow this procedure to enter the instrument serial number in the Pentra C400 software.
1. Press Edit.
2. Type your instrument serial number in the Serial # field.
You will find your instrument serial number on the serial label located at the back of the
instrument.
4.1.3. To Configure the Level Detection
Follow this procedure to enable or to disable the sample and reagent level detections.
1. Press Edit.
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2. To enable or to disable the sample level detection, select or deselect the Sample option in the
Level detection area.
■ If selected, the sample level detection is enabled.
■ If unselected, the sample level detection is disabled.
If the sample level detection is disabled, only sample cups must be used.
3. To enable or to disable the reagent level detection, select or deselect the Reagent option in the
Level detection area.
■ If selected, the reagent level detection is enabled.
■ If unselected, the reagent level detection is disabled.
Working with the reagent level detection disabled can pose important
contamination problems, and erroneous test results may occur.
4.1.4. To Enable or Disable the Cuvette Changer
Follow this procedure to enable or to disable the cuvette changer.
1. Press Edit.
2. To enable or to disable the cuvette changer, select or deselect the Cuvettes changer option.
■ If selected, the cuvette changer is enabled.
■ If unselected, the cuvette changer is disabled.
If the cuvette changer is disabled, cuvettes must be manually loaded and unloaded
(refer to the Maintenance and Troubleshooting > Troubleshooting > Analytical
Module > Cuvette Changer > To Manually Load Cuvettes chapter).
■ To Manually Load Cuvettes, p.383
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4.1.5. To Configure the Pressure Detection
Follow this procedure to enable or to disable the pressure detection of sample and
reagent needles.
1. Press Edit.
2. To enable or to disable the sample needle pressure detection, select or deselect the Sample
detection option in the Pressure Detections area.
■ If selected, the sample needle pressure detection is enabled.
■ If unselected, the sample needle pressure detection is disabled.
3. To enable or to disable the reagent needle pressure detection, select or deselect the Reagent
detection option in the Pressure Detections area.
■ If selected, the reagent needle pressure detection is enabled.
■ If unselected, the reagent needle pressure detection is disabled.
4.1.6. To Enable or Disable Barcode Readers
Follow this procedure to enable or disable the sample and reagent barcode readers.
1. Press Edit.
2. To enable or disable the sample barcode reader, select or deselect the Sample option in the
Barcode Reader area.
■ If selected, the sample barcode reader is enabled.
■ If unselected, the sample barcode reader is disabled.
If the sample barcode reader is disabled:

■ Samples are identified by rack position (position mode) and you must therefore
ensure that the sample tube is physically positioned as programmed in the
worklist.
■ Only the sample racks numbered from 01 to 06 must be used and must be
respectively positioned on the sample tray positions numbered from 01 to 06.
■ No more than 60 requests can be programmed in the worklist.
■ Calibrators and controls must also be configured on the sample racks numbered
from 01 to 06.
This parameter cannot be modified if tests are ordered, pending, incomplete or for
validation.
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3. To enable or to disable the reagent barcode reader, select or deselect the Reagent option in the
Barcode Reader area.
■ If selected, the reagent barcode reader is enabled.
■ If unselected, the reagent barcode reader is disabled.
Working with the reagent barcode reader disabled, you must ensure that solutions
are physically positioned as programmed in the Reagent Configuration menu.
4.1.7. To Configure the Automatic Startup
Follow this procedure to configure the automatic startup.
If an automatic startup is programmed, the instrument automatically starts every day at a specified
time.
1. Press Edit.
2. Select the Automatic startup option to enable automatic startup.
3. Specify the startup time.
4.1.8. To Configure Automatic Standby Mode
Follow this procedure to configure automatic standby mode.
If an automatic standby mode is programmed, the instrument automatically enters standby mode after
a specified inactivity time.
1. Press Edit.
2. Select the Standby mode check option to enable automatic standby mode.
3. Specify the inactivity time.
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4.1.9. To Configure Automatic Cleanings
Follow this procedure to configure automatic cleanings.
If automatic cleanings are programmed, ISE module and/or needles are automatically cleaned at the
instrument shutdown.
1. Press Edit.
2. Select the ISE cleaning option to program by default an ISE module cleaning at the instrument
shutdown.
3. Select the System cleaning option to program by default a needles cleaning at the instrument
shutdown.
■ If you selected the ISE cleaning option, you will have to choose the cleaner from the ISE Cleaning
dropdown list at the instrument shutdown.
■ If you selected the System cleaning option, you will have to choose the cleaner from the System
Cleaning dropdown list at the instrument shutdown.
Refer to the Workflow > End of Day > To Shut Down the Instrument chapter.
■ To Shut Down the Instrument, p.214
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4.1.10. To Configure Racks
Follow this procedure to configure the racks used on the instrument.
1 = List of rack types

2 = List of available racks
3 = List of racks used on the instrument
1. Press Edit.
2. Select a rack type.
Rack numbers displayed in the list of available racks and the list of racks used on the instrument
are updated.
Racks used on the instrument by

Rack type Available racks
default
Sample rack # 01 to 40 # 01 to 06
Sample cup rack # 41 to 70 # 41 to 42
Calibrator sample rack # 71 to 84 # 71 to 72
Control sample rack # 85 to 99 # 85 to 86
Reagent rack # 60 to 99 # 60 to 65
Calibrator reagent rack # 01 to 29 # 01 to 02
Control reagent rack # 30 to 59 # 30 to 31
3. To add or to remove racks used on the instrument:

a. Select a rack number.
b. Press Next to add the rack number in the list of racks used on the instrument or press
Previous to remove the rack number from the list of racks used on the instrument.
c. Repeat steps a and b for each rack number.
A rack number cannot be removed from the list of racks used on the instrument if a
solution is still configured on this rack number.
4. Repeat steps 2 and 3 for each rack type.

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4.1.11. ISE Module Configuration (Option)
4.1.11.1. To Enable or Disable ISE Module
Follow this procedure to enable or disable the ISE module.
This parameter cannot be modified if associated tests are ordered, pending, incomplete or for
validation.
1. Press Edit.
2. Select or deselect the Activate ISE Module check box to enable or disable the ISE module.
■ If selected, the ISE module is enabled.
■ If unselected, the ISE module is disabled.
If the ISE module is disabled, the ISE Module Status button of the main menu is
unavailable, the ISE applications are not displayed anymore in the request capture
screen nor in Main menu > Services > Application Configuration > Applications,
all ISE functionalities of Customer Services menu are not displayed anymore.
4.1.11.2. To Activate or Deactivate an Electrode
Follow this procedure to activate or deactivate an electrode.
1. Press Edit.
2. To activate or deactivate an electrode, select or deselect the corresponding check box in the
Activated electrode area.
■ If selected, the electrode is activated.
■ If unselected, the electrode is deactivated.
■ An electrode cannot be deactivated if associated tests are ordered, pending,

incomplete or for validation.
■ If an electrode is deactivated, the calibration results for this electrode are not
displayed anymore in the ISE calibration results screen, the ISE applications for
this electrode are not displayed anymore in the request capture screen.
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4.1.12. To Configure the Automatic Back-up Cassette Option
Follow this procedure to enable or to disable the automatic back-up cassette option.
1. Press Edit.
2. To enable or to disable the automatic back-up cassette option, select or deselect the Activate
dynamic cassette change option.
■ If selected, the automatic back-up cassette option is enabled.
If several cassettes of the same solution are installed on the reagent tray, the first cassette
installed is active and the next cassettes are inactive. If the automatic back-up cassette option
is enabled, the next cassettes are called back-up cassettes. Back-up cassettes are
automatically activated when the cassette in use is empty.
■ If unselected, the automatic back-up cassette option is disabled.
4.1.13. To Enable or To Disable Cooling Unit
Follow this procedure to enable or disable the cooling unit.
1. Press Edit.
2. To enable or disable the cooling unit, select or deselect the Activate Cold Area option.
■ If selected, the cooling unit is enabled.
■ If unselected, the cooling unit is disabled.
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4.1.14. To Program the Time Lapse for Displaying Calibrations that Will
Expire
Follow this procedure to configure the time lapse for displaying calibrations that will
expire.
When adding a calibration request, you can display calibrations that will expire in a programmed time
lapse (refer to the Workflow > Calibration and Control > Calibration and Control Worklists > To Add
Calibration Requests chapter). The Calibrations expired time windows area allows you to configure
this time lapse (from 0 to 96 hours).
1. Press Edit.
2. Configure the time lapse from the Hour(s) spin box in the Calibrations expired time windows
area.
■ To Add Calibration Requests, p.118
4.1.15. To Enable or To Disable Automatic Export of Results
Follow this procedure to enable or to disable the automatic export of results to a USB key.
1. Press Edit.
2. To enable or to disable the automatic export of results to a USB key, select or deselect the
Activate export of the results on USB key option.
■ If selected, the automatic export of results is enabled.
If the automatic export of results is enabled, all the completed test results are saved in a .csv
file on a USB key at each end of run. ISE test results and ratio results are not exported.
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.csv file example
instrument.
■ If unselected, the automatic export of results is disabled.
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4.2. Local Settings
■ Configure date and time.

■ Change software language.
■ Change keyboard configuration.
■ Configure sample barcode reader.
■ Update online help.
■ Manage database and client parameters.
Access: Main menu > Services > System Configuration > Local Settings
4.2.1. Configuring Date and Time
4.2.1.1. To Change the Date Format
Follow this procedure to select one of the three available date formats.
By default, the date format is MM/dd/yyyy.
1. Press Edit.
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2. Choose a date format from the Date Format dropdown list.

■ MM/dd/yyyy
■ dd/MM/yyyy
■ yyyy/MM/dd
dd stands for days, MM stands for months and yyyy stands for years.
The instrument is restarted after user confirmation.
4.2.1.2. To Change the Time Format
Follow this procedure to select one of the two available time formats.
By default, the time format is HH:mm:ss.
1. Press Edit.
2. Choose a time format from the Time Format dropdown list.
■ hh:mm:ss ampm
■ HH:mm:ss
hh stands for hours, mm stands for minutes and ss stands for seconds.
4.2.1.3. To Change the Date and Time
Follow this procedure to change the date and time of the instrument.
The date and time cannot be modified if tests are ordered, pending, incomplete or for validation.
1. Press Edit.
2. Modify the date as follows:
a. Press the arrow from the Date field to open the calendar.
b. To choose a month, use the left and right arrows. Then choose the day.
c. When done, click randomly outside the calendar to close it.
3. Set the hours, minutes and seconds in the Time field.
4. If the hh:mm:ss ampm time format is selected, either choose am or pm.
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4.2.2. To Change Software Language
Follow this procedure to change the language of user interface, printouts and data sent to
host.
1. Press Edit.
2. Choose the software language from the Language List dropdown list.
■ English
■ French
■ German
■ Italian
■ Spanish
■ Portuguese
■ Greek
■ Polish
4.2.3. To Change Keyboard Configuration
Follow this procedure to change the keyboard language.
1. Press Edit.
2. Press Change Configuration.
A dialog box is displayed.
3. Choose the keyboard language in the dialog box.
4. Press OK in the dialog box.
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4.2.4. To Configure Sample Barcode Reader
Follow this procedure to configure the barcode types used in your laboratory.
1. Press Edit.
2. Select the barcode types used in your laboratory from the following options.
■ ITF 2/5 (2 of 5 interleaved)
■ Code 39
■ Code 128
■ Codabar
3. If the ITF 2/5 barcode type is selected, configure the ITF 2/5 Check Digit option.
■ If unselected, the ITF 2/5 barcode type is used without check digit.
HAX0174 (1207230174). Nevertheless, if you use the 2 of 5 interleaved barcode
type without check digit, you must use the sample rack labels from HAX0273
(1207230273) to HAX0281 (1207230281).
■ If selected, the ITF 2/5 barcode type is used with check digit.
4. If the Code 39 barcode type is selected, configure the Code 39 Check Digit option.
■ If unselected, the Code 39 barcode type is used without check digit.
■ If selected, the Code 39 barcode type is used with check digit.
4.2.5. To Update the Online Help
Follow this procedure to update the Pentra C400 online help (user manual).
The Pentra C400 online help is maintained and updated by HORIBA Medical with the Documentation
media (USB flash drive).
The contents of this media can also be viewed on any computer having the Adobe™
Acrobat™ Reader software (version 6.0 or later).
1. Install the Documentation media on the instrument.
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2. Press Edit.
3. Press Update help.
The Documentation media application is launched.
4. Choose your language.
5. Press Update Help.
The Pentra C400 online help is updated.

4.2.6. Managing Database and Client Parameters
4.2.6.1. To Save Client Parameters
Follow this procedure to save your instrument configuration.
The Serial # field in Main menu > Services > System Configuration > Analyser must be completed.
Refer to the System Configuration > Analyser > To Enter the Instrument Serial Number chapter.
The client parameters backup includes the current database, the columns configuration, the
parameters of System Configuration menu and Customer Services menu. The parameters
configured by your local representative and the default printer are not saved.
1. Press Edit.
2. Press Save in the Save client parameters area.
■ USB key.
3. If you use a USB key, install it on your instrument.
instrument.
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The client parameters are saved in a file named with the backup date and time and the instrument
serial number.
■ To Enter the Instrument Serial Number, p.302
4.2.6.2. To Restore Client Parameters
Follow this procedure to restore your instrument configuration previously saved on the
hard disk or a USB key.
1. Press Edit.
2. Press Restore in the Restore client parameters area.
■ USB key.
3. If you use a USB key, install it on your instrument.
instrument.
4. Select the support type.

The list of backup files saved on the selected support is displayed.
5. Select the backup file that you want to restore.
6. Select the client parameters that you want to restore from the following options.
■ Size and order of columns: If selected, the columns configuration is restored and the warning
#635 Restore column configuration the [date and time] by [user name] is triggered.
■ System configuration: If selected, the parameters of System Configuration menu and
Customer Services menu are restored and the warning #634 Restore system configuration the
[date and time] by [user name] is triggered.
This parameter cannot be restored if tests are ordered, pending, incomplete or for
validation.
■ Database: If selected, the database is updated (if necessary) then restored, and the warning
#628 Restore database saved on [date and time] by [user name] is triggered.
■ If necessary, the database is updated after user confirmation.
■ The instrument is restarted after user confirmation.
The selected client parameters are restored and the corresponding warnings are triggered.
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4.2.6.3. To Restore Database
Follow this procedure to restore a database previously saved on the instrument.
Each time a new worklist is created, the current database is saved on the instrument. Up to eight
databases are saved and numbered from the most recent to the oldest.
1. Press Edit.
2. Press Restore database.
The list of databases saved on the instrument is displayed.
3. Select the database that you want to restore.
The selected database is restored and the warning #628 Restore database saved on [date and time]
by [user name] is triggered.
4.3. Host Connection
■ Configure the host connection.

■ Check the host connection and reset it if necessary.
■ Delete all pending data.
■ Test the host connection.
■ View the communication frames and search for a message in these frames.
Access: Main menu > Services > System Configuration > Host Connection
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4.3.1. To Configure the Host Connection
Follow this procedure to configure the host connection.
Host connection must be configured by an authorized technician using the Output format
for host connection document. This document is available online at www.horiba.com.
1. Press Edit.
2. Configure the connection parameters as follows:
a. Select the speed in Baud from the following options: 1200, 2400, 4800, 9600, 19200, 38400,
57600, 115200.
Set to 9600 by default.
b. Select the parity from the following options: None, Odd, Even.
Set to None by default.
c. Select the stop bit from the following options: 1 Stop, 2 Stop.
Set to 1 Stop by default.
d. Select the protocol from the following options: Xon/Xoff, None.
Set to Xon/Xoff by default.
3. Configure the Query Mode option.
■ If selected, the Query Mode option is enabled. If a sample tube is read on the tray and no
associated request is found in the worklist, the instrument automatically asks the host if there
is a programmed request for this tube.
■ If unselected, the Query Mode option is disabled.
This option is selectable only if the sample identification mode is set to Identification
in the Main menu > Services > System Configuration > Analyser.
4. If the Query Mode option is enabled, configure the Sending validated samples option.
■ If selected, the Sending validated samples option is enabled. The Host request button is
available in the Work Balance menu or in the result list. This button allows you to manually ask
the host if there are additional tests programmed for a validated patient sample.
■ If unselected, the Sending validated samples option is disabled.
5. Configure the Handling spaces on the left side of SID option.
■ If selected, the space character is allowed on the left side of the sample ID. In this case, the
space character is indicated by a rectangle on printouts.
■ If unselected, the space character is not allowed on the left side of the sample ID. In this case,
the space character is systematically deleted.
6. Configure the automatic transmission of patient results to the host from the following options.
■ Nothing: If selected, patient results are not automatically sent.
■ Order: If selected, patient results are automatically sent by request after validation of all results
of the request.
■ Test: If selected, patient results are automatically sent by test after result validation.
7. Configure the automatic transmission of control results to the host from the following options.
■ Nothing: If selected, control results are not automatically sent.
■ Test: If selected, control results are automatically sent by test after result validation.
8. Enter the instrument identification number for the host in the Analyser Id field.
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4.3.2. Checking the Host Connection
4.3.2.1. To Reset the Host Connection
Follow this procedure to check the host connection and to reset it if necessary.
1. Press Edit.
2. Press the Reset connection button:
The host connection is checked:

■ If it works properly, a dialog box informs you that the host connection is ok.
■ If it does not work, the host connection is reset after user confirmation.
4.3.2.2. To Purge the Host Orders
Follow this procedure to delete all pending data (receipt and transmission).
1. Press Edit.
2. Press the Purge host orders button:
Pending data is purged after user confirmation.
4.3.2.3. To Test the Host Connection
Follow this procedure to test the host connection.
No data receipt nor data transmission in progress.
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1. Press Edit.
2. Press the Test communication button:
The instrument sends a message to the host and waits for the host to confirm the message
receipt. The Received Character field displays the test result:
Message Description
ACK The host confirms the message receipt.
XXX The host does not confirm the message receipt.
Time out The host did not confirm within the expected time.
Process NOK The host connection does not work.
4.3.2.4. To Search Within the Communication Frames
Follow this procedure to view the communication frames and to search for a message
within these frames.
1. Press Edit.
2. Press the Connection Spy button:
The communication frames (data receipt and transmission) are displayed from the oldest to the
most recent. The screen is continuously refreshed.
Search tools are available. The screen is not refreshed anymore.

4. Type the message you want to search for in the Text to Find field (30 characters maximum).
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5. Select the Case Sensitive option to distinguish between uppercase and lowercase letters.
6. Select the Whole Words option to search for the complete message.
7. Choose the search direction from the following options.
■ Search Forward: To search from the oldest to the most recent.
■ Search Backward: To search from the most recent to the oldest.
8. Press Next to launch the search.
■ The message is highlighted if found.
■ A dialog box informs you if the message was not found.
4.4. Printer
■ Customize the printouts headers.

■ Configure automatic printouts.
■ Add a new printer.
Contact your local HORIBA Medical representative for detailed information concerning
the procedure to add a new printer.
■ Configure the printer properties.
■ Select the default printer.
■ Remove a printer.
Access: Main menu > Services > System Configuration > Printer
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4.4.1. To Configure Printouts Headers
Follow this procedure to customize the printouts headers.
1. Press Edit.
2. Fill in the Header fields to customize the header of the condensed, standard and detailed printout
formats.
Six fields of 20 characters maximum each are available.
3. Fill in the Portrait header fields to customize the header of the portrait printout format.
Eight fields of 40 characters maximum each are available.
4. Add a logo to customize the header of the portrait printout format as follows:
a. Save your logo on a CD-ROM or a USB key.
Logo characteristics:
■ Size: 55 x 45 mm (Width x Height)
■ Format: .jpeg file
instrument.
b. Install your support on the instrument.

c. Press the Windows™ Explorer button:
d. Select the support type from the dropdown list.

e. Select the logo and press OK.
4.4.2. To Configure Automatic Printouts
Follow this procedure to configure automatic printouts.
1. Press Edit.
2. Configure automatic printouts of patient results as follows:
a. Select the Complete option to automatically print patient results when validated.
b. Select the order in which patient results are printed from the following options.
■ Sort by Order: If selected, results are sorted by patient.
■ Sort by sample result: If selected, results are sorted by run date.
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c. Select the printout format from the following options:

■ condensed,
■ standard,
■ detailed,
■ portrait.
Detailed and portrait printout formats are unavailable if the Sort by Order option is
selected.
3. Configure automatic printouts of control results as follows:

a. Select the Complete option to automatically print control results when validated.
b. Select the printout format from the following options:
■ condensed,
■ standard,
■ detailed.
4. Configure automatic printouts of calibration results as follows:
a. Select the Complete option to automatically print calibration results when validated.
b. Select the printout format from the following options:
■ standard,
■ detailed.
4.4.3. Configuring Printers
4.4.3.1. To Configure the Printer Properties
Follow this procedure to configure the printer properties.
1. Press Edit.
2. Select the printer of which you want to configure the properties from the Printer List dropdown
list.
3. Press Printer Properties.
The selected printer properties window is displayed.
4. Change the selected printer properties where necessary and press OK.
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4.4.3.2. To Select the Default Printer
Follow this procedure to select the default printer.
1. Press Edit.
2. Select the printer that you want to configure by default from the Printer List dropdown list.
3. Press Set Default Printer.
The selected printer becomes the default printer.
4.4.3.3. To Delete a Printer
Follow this procedure to remove a printer.
1. Press Edit.
2. Select the printer that you want to remove from the Printer List dropdown list.
3. Press Delete Printer.
The selected printer is removed from the list.
4.5. Results Validation

■ Configure calibrations automatic validation.
■ Configure controls automatic validation and Westgard rules.
■ Configure patients automatic validation.
Access: Main menu > Services > System Configuration > Results validation
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4.5.1. To Configure Calibrations Automatic Validation
Follow this procedure to configure automatic validation of calibration results.
1. Press Edit.
2. Select the Automatic validation option in the Calibrator area to enable calibrations automatic
validation.
If selected, calibration results are automatically validated on condition that:
■ No point used for calculation is flagged (except with the analytical flag CALC_RANGE_HIGH /
LOW).
■ For each calibrator level, deviations (Dev_Rep and Dev_C) do not exceed the authorized
values.
■ The calibration factor is not out of the programmed values.
3. Select the Quality flag option in the Calibrator area to block the automatic validation when the
calibration is flagged with a quality flag.
4.5.2. To Configure Controls Automatic Validation
Follow this procedure to configure automatic validation of control results and to configure
Westgard rules.
1. Press Edit.
2. Select the Automatic validation option in the Control area to enable controls automatic
validation.
If selected, control results are automatically validated on condition that they are not flagged
(except with the analytical flag CONF_RANGE_HIGH_W / LOW_W).
3. Select the Quality flag option in the Control area to block the automatic validation when the
control is flagged with a quality flag.
4. Select the Westgard rule validation option to enable Westgard rules.
For detailed information concerning Westgard rules, refer to the Quality Assurance >
Westgard Rules chapter.
If Westgard rules are enabled, the Apply to values outside confidence range option is selected
by default and cannot be unselected. In this case, Westgard rules apply when the control results
are outside the confidence range.
5. If Westgard rules are enabled, you can select the Apply rules 4, 5 and 6 (drift) to values inside
confidence range option to apply the Westgard rules 4, 5 and 6 to control results inside the
confidence range (suspicion of drift).
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4.5.3. To Configure Patients Automatic Validation
Follow this procedure to configure automatic validation of patient results.
1. Press Edit.
2. Choose the validation mode of patient results from the following options.
■ Automatic validation: If selected, all patient results are automatically validated.
■ Review of all results: If selected, all patient results must be manually validated.
■ Review of exception: If selected, patient results are automatically validated on defined
criteria.
3. If the Review of exception option is selected, choose the criteria on which patient results are
automatically validated.
■ Analytical flag: Selected by default and not modifiable, patient results are automatically
validated on condition that they are not flagged (except with the analytical flag
REF_RANGE_HIGH / LOW).
■ Reference range flag: If selected, patient results flagged with REF_RANGE_HIGH / LOW must
be manually validated.
■ Delta check flag: If selected, patient results flagged with the delta check flag must be
manually validated.
■ Quality flag: If selected, patient results flagged with a quality flag must be manually validated.
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Settings
4.6. To Configure Sound Alarms
Follow this procedure to configure sound alarms.
Access: Main menu > Services > System Configuration > Audible alarm
1. Press Edit.
2. Choose the sound alarms language from the dropdown list at the top of the screen.
■ English
■ French
■ German
■ Italian
■ Spanish
■ Portuguese
■ Greek
■ Polish
3. Select the events for which you want to hear a sound alarm from the following options.
■ System alarm: If selected, an alarm sounds when a system alarm is triggered.
■ Warning: If selected, an alarm sounds when a system warning is triggered.
■ Pre-analytical alarm: If selected, an alarm sounds when a sampling alarm is triggered.
■ Manual validation: If selected, an alarm sounds when a manual validation is required.
■ Maintenance warning: If selected, an alarm sounds when a maintenance alert is triggered.
■ Reagent processing: If selected, an alarm sounds when the instrument turns to "Reagent
processing" status.
■ Ready: If selected, an alarm sounds when the instrument turns to "Ready" status.
■ Sample tray reading: If selected, an alarm sounds when the sample tray is not accessible
anymore.
For each event, press Test to hear the corresponding alarm sound.
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4. For each selected event, press the up or down arrows from the Repeat spin box to configure the
number of times the alarm should sound (from one to five times).
5. Set the sound volume using the slider.
When several sound alarms are simultaneously triggered, only the alarm having the
highest priority sounds.
Sound alarms priority (from highest to lowest): System alarm > Warning > Pre-analytical
alarm > Manual validation > Maintenance warning > Reagent processing > Ready >
Sample tray reading.
4.7. Configuring Maintenance Alerts
4.7.1. To Configure Maintenance Alerts
Follow this procedure to configure the maintenance procedures that must be performed
on the instrument and when they must be performed.
Access: Main menu > Services > System Configuration > Maintenance
Once the maintenance procedures are configured, the instrument checks that they are performed
when necessary. If a maintenance procedure is not performed on time, a maintenance alert is
triggered.
Moreover, the configured maintenance procedures are listed in the Maintenance log when they are
performed.
Most of the maintenance procedures use a software function from the Customer Services menu.
These procedures are automatically notified in the log when they are performed.
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Settings
Some maintenance procedures do not use a software function. These procedures must be manually
notified in the log when they are performed.
1. Press Edit.
2. Select the maintenance procedures that must be performed on your instrument from the Active
area.
3. For each selected procedure, configure when it must be performed from the Occurrence area.
The following frequencies are selectable:
■ On request,
■ Daily,
■ Weekly,
■ Monthly,
■ Every 2 months,
■ Every 6 months,
■ Annually.
Refer to the Configuring Maintenance Alerts > Maintenance Alerts Default Configuration
chapter to know the maintenance alerts default configuration.
■ Maintenance, p.90
■ Maintenance Alerts Default Configuration, p.330
4.7.2. Maintenance Alerts Default Configuration
The table below gives the maintenance alerts default configuration and indicates, for each procedure,
if it is automatically notified in the Maintenance log when performed or if it must be manually notified.
For detailed information concerning the procedure to configure maintenance alerts, refer
to the Configuring Maintenance Alerts > To Configure Maintenance Alerts chapter.
Maintenance procedure Frequency Notified in the log

Syringes replacement Every 6 months Automatically
Sample needle replacement Annually Automatically
Reagent needle replacement Annually Automatically
Mixer paddle replacement On request Automatically
Lamp replacement On request Automatically
Instrument cleaning and decontamination On request Manually
Filter replacement Every 2 months Manually
Glycol level checking Every 2 months Manually
ISE module activation Daily Automatically
ISE module cleaning Weekly Automatically
ISE module etching Weekly Automatically
Needle deproteinization (with mixer) Weekly Automatically
Wash tower cleaning Monthly Automatically
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Maintenance procedure Frequency Notified in the log

Syringe plunger tips Monthly Automatically
Qualitest / Precitest Monthly Manually
■ To Configure Maintenance Alerts, p.329
4.8. Users
■ Create a new user account.

■ Modify a previously created user account.
■ Delete a previously created user account.
Access: Main menu > Services > System Configuration > Users
4.8.1. Users Accounts Management
Each user account has a personal and unique user name or login and an associated password.
Four user levels are available in the Pentra C400 software.
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Settings
■ User: Users have access to daily working operations.

■ Admin: Administrators have access to system configuration, user accounts management and
applications configuration.
■ Sales: Sales have access to specific system configuration parameters (number of user channels,
Test Counter accessibility, possible use of expired calibrations, calibrators, controls and
solutions).
■ Tech: Technicians have access to the Diagnostics menu.
4.8.2. To Create a User Account
Follow this procedure to create a new user account.
Only administrators (Admin) can create, modify and delete user accounts.
1. Press Add new.

2. Type the user name (three to ten characters) in the Login field.
The user name must be unique.
3. Type the password (ten characters maximum) in the Current Password field.
The password must be unique.
4. Confirm the password in the Confirm Current Password field.
5. Choose the user level from the Level dropdown list.
The new user account is added in the users list.
4.8.3. To Modify a User Account
Follow this procedure to modify a previously created user account.
1. Select the user account in the users list.

2. Press Edit.
3. Type the password in the Old Password field.
4. Type the new password (ten characters maximum) in the Current Password field.
The password must be unique.
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5. Confirm the password in the Confirm Current Password field.

6. If necessary, change the user level from the Level dropdown list.
The user account is modified.
4.8.4. To Delete a User Account
Follow this procedure to delete a previously created user account.
1. Select the user account in the users list.

2. Press Delete.
3. Type the password in the Current Password field.
The user account is removed from the users list.
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Settings
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Maintenance and Troubleshooting
1. Customer Services Overview........................................................................................ 336
2. Maintenance......................................................................................................................... 339
2.1. Daily Procedures........................................................................................................................ 339
2.2. Weekly Procedures.................................................................................................................... 341
2.3. Monthly Procedures................................................................................................................... 344
2.4. Bimonthly Procedures (Every Two Months)............................................................................... 352
2.5. Other Procedures.......................................................................................................................355
2.6. Consumables and Spare Parts.................................................................................................. 369
2.7. Maintenance Schedule...............................................................................................................371
3. Troubleshooting.................................................................................................................. 372
3.1. Analyzer Power Problems.......................................................................................................... 372
3.2. Printer Operation Problems....................................................................................................... 373
3.3. Reagent and Sample Trays........................................................................................................373
3.4. Sampling System....................................................................................................................... 378
3.5. Analytical Module.......................................................................................................................380
3.6. ISE Module (Option)................................................................................................................... 386
3.7. Water and Waste Tanks............................................................................................................. 389
3.8. Cooling Unit............................................................................................................................... 390
3.9. Result Problems.........................................................................................................................392
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Customer Services Overview
1. Customer Services Overview
The table below gives a summary of what can be achieved from the Customer Services menu.
Cycles tab
Heading Description Refer to

System
Replace Lamp To replace the lamp Maintenance > Other Procedures > To Replace
the Lamp
Replace Sample needle To replace the sample needle Maintenance > Other Procedures > To Replace
the Sample Needle
Replace Reagent ■ To clean the reagent needle ■ Maintenance > Monthly Procedures > To
needle external part Clean the Reagent Needle (External Part)
■ To replace the reagent needle ■ Maintenance > Other Procedures > To
Replace the Reagent Needle
Replace Mixer Paddle To replace the mixer paddle Maintenance > Other Procedures > To Replace
the Mixer Paddle
Replace Syringe To replace the syringes Maintenance > Other Procedures > To Replace
Syringes
Initialize To perform a mechanical initialization -
of the instrument
Clean wash tower To clean wash towers Maintenance > Monthly Procedures > To Clean
Wash Towers
Replace syringe plunger To replace the syringe plunger tips Maintenance > Monthly Procedures > To Replace
tips Syringe Plunger Tips
Sample pressure To calibrate the sample needle ■ Maintenance > Monthly Procedures > To
calibration pressure detection Replace Syringe Plunger Tips
■ Maintenance > Other Procedures > To
Replace Syringes
Replace Sample Needle
Reagent pressure To calibrate the reagent needle ■ Maintenance > Monthly Procedures > To
calibration pressure detection Replace Syringe Plunger Tips
Replace Syringes
Reagent level detection To calibrate the reagent level ■ Maintenance > Monthly Procedures > To
calibration detection Clean Reagent Needle (External Part)
Cleaning To clean needles and mixer ■ Maintenance > Daily Procedures > To Clean
Needles with Deproteinizer
■ Maintenance > Weekly Procedures > To
Clean Needles and Mixer with Deproteinizer
Loader To check the cuvette changer Troubleshooting > Analytical Module > Cuvette
Changer > To Check Cuvette Changer
Priming
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Priming Cycle To prime the fluidic system ■ Maintenance > Monthly Procedures > To
Clean Wash Towers
■ Maintenance > Monthly Procedures > To
Replace Syringe Plunger Tips
■ Maintenance > Bimonthly Procedures (Every
Two Months) > To Replace Filter
Replace Syringes
Replace the Sample Needle
■ Troubleshooting > Sampling System >
Syringes Problem
■ Troubleshooting > Sampling System >
Reproducibility Problems
Filling up To fill up the fluidic system after -
having drained it or after having
replaced the distilled water tank
Draining To drain the fluidic system after -
having disconnected the distilled
water tank
ISE tab

Activated electrode To activate or to deactivate an Settings > System Configuration > Analyser > ISE
electrode Module Configuration (Option) > To Activate or To
Deactivate an Electrode
Cycles
Stop ISE cycle To stop the cycle in progress -
Change electrode To replace the electrodes Maintenance > Other Procedures > To Replace
Electrodes (Option)
Fluidic Initialization To prime the reagents in the fluidic Maintenance > Other Procedures > ISE Module
system Shutdown (Option) > To Shut Down the ISE
Module Over 3 Days
Stabilization of Fluidic To rinse the fluidic system -
system
Prime flow system To prime the reagents in the fluidic -
system
Drain To drain the reagents from the fluidic Maintenance > Other Procedures > ISE Module
system Shutdown (Option) > To Shut Down the ISE
Module Over 3 Days
Global Initialization To perform a global initialization of ■ Maintenance > Other Procedures > To
the ISE module Replace ISE Reagents (Option)
Replace Electrodes (Option)
■ Maintenance > Other Procedures > ISE
Module Shutdown (Option) > To Shut Down
the ISE Module Within 3 Days
■ Maintenance > Other Procedures > ISE
Module Shutdown (Option) > To Shut Down
the ISE Module Over 3 Days
Mechanical Initialization To initialize the syringes -
Shutdown To shutown the ISE module Maintenance > Other Procedures > ISE Module
Shutdown (Option) > To Shut Down the ISE
Module Within 3 Days
ISE Cleaning Solution To clean the ISE module Maintenance > Daily Procedures > To Clean the
ISE Module with Etching (Option)
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ISE activation To perform an ISE module activation Workflow > Start of Day > To Perform ISE Module
Activation (Option)
ISE automatic To perform a complete ISE module Maintenance > Weekly Procedures > To Clean the
maintenance cleaning ISE Module (Option)
ISE Status ■ To check the ISE module status Troubleshooting > ISE Module (Option) > To
before a maintenance operation Check ISE Module Status and ISE Error Code
■ To check the ISE error code from Customer Services Menu
when you have the ISE Module
Status button displayed in red
on the main menu
Analyser tab

Sample Tray To check the sample barcode reader Troubleshooting > Reagent and Sample Trays >
Sample Tray > To Check the Sample Barcode
Reader
Temperatures
Reaction Tray To check the reaction tray Troubleshooting > Analytical Module > Reaction
temperature Tray > Reaction Tray Temperature Problem
Expected value: 37°C +/- 0.2°C
(99°F +/- 0.36°F)
Reagent Tray To check the temperature in the Troubleshooting > Reagent and Sample Trays >
refrigerated area of reagent tray Reagent Tray > Reagent Tray Temperature
Expected value: 4°C - 10°C Problem
(39°F - 50°F)
Needle To check the reagent needle Troubleshooting > Sampling System > Reagent
temperature Needle Temperature Problem
Expected value: 37°C +/- 0.5°C
(99°F +/- 0.9°F)
Ambient temperature To check the room temperature Troubleshooting > Analytical Module > Reaction
Tray > Reaction Tray Temperature Problem
Spectro Gain To check the spectrophotometer Troubleshooting > Analytical Module > Lamp and
gains for each wavelength Spectrophotometer > To Check
Spectrophotometer Gains
Barcode tab
The Barcode tab allows you to make sure that the sample barcode reader correctly reads a barcode
label. Refer to the Troubleshooting > Reagent and Sample Trays > Sample Tray > To Check Correct
Reading of a Barcode Label chapter.
Test Counter tab (On Request)

The Test Counter allows you to monitor your activity balance. Refer to the Quality Assurance > Test
Counter (On Request) chapter.
■ Troubleshooting, p.372
■ Test Counter (On Request), p.92
■ To Activate or Deactivate an Electrode, p.308
■ To Perform ISE Module Activation (Option), p.110
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2. Maintenance
The maintenance procedures identified in this chapter are mandatory for proper use and operation of
the Pentra C400.
Failure to execute any of these recommended procedures may result in poor reliability of
the system.
HORIBA Medical recommends you to perform maintenance procedures at the end of the
day.
2.1. Daily Procedures
2.1.1. To Clean the ISE Module with Etching (Option)
Clean the ISE module with the ABX Pentra Etching CP A11A01769 on a daily basis if
more than 20 samples are run daily.
■ Consumables and spare parts: ABX Pentra Etching CP A11A01769

■ The ABX Pentra Etching CP A11A01769 must be previously configured in the Reagent
Configuration menu and placed on the reagent tray at room temperature.
■ The ISE module status must be ≥ 4 (module sleeping).
■ If less than 20 samples are run daily, perform a complete ISE module cleaning every
week. Refer to the Maintenance and Troubleshooting > Maintenance > Weekly
Procedures > To Clean ISE Module (Option) chapter.
1. Choose ETCH (ABX Pentra Etching CP A11A01769) from the ISE Cleaning Solution dropdown
list.
2. Press ISE Start to clean the ISE module.
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The ISE module can be automatically cleaned during instrument shutdown if programmed
in Main menu > Services > System Configuration > Analyser.
After the ISE module has been cleaned:

■ Remove the ABX Pentra Etching CP A11A01769 from the tray, close it and store it at room
temperature.
■ Perform an ISE module activation.
2.1.2. To Clean Needles with Deproteinizer
Clean the needles with ABX Pentra Deproteinizer CP A11A01754 on a daily basis.
Access: Main menu > Services > Customer Services > Cycles
■ Consumables and spare parts: ABX Pentra Deproteinizer CP A11A01754

■ The ABX Pentra Deproteinizer CP A11A01754 must be previously configured in the Reagent
Configuration menu and placed on the reagent tray.
1. Choose the ABX Pentra Deproteinizer CP A11A01754 from the Needle Cleaning Solution
dropdown list.
2. If the Mixer cleaning option is selected, clear it.
3. Press Needle Cleaning to clean the needles.
The needles can be automatically cleaned during the instrument shutdown if programmed
in Main menu > Services > System Configuration > Analyser.
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2.2. Weekly Procedures
2.2.1. To Clean the ISE Module (Option)
Perform a complete ISE module cleaning on a weekly basis.
■ Consumables and spare parts: ABX Pentra Deproteinizer CP A11A01754, ABX Pentra Etching
CP A11A01769, 200 µL of serum or plasma into a sample cup, ABX Pentra Dummy Electrode
A11A01851, Cleaning kit for Chloride electrode XEA935AS (1209159935)
■ The ABX Pentra Etching CP A11A01769 must be previously configured in the Reagent
Configuration menu and placed on the reagent tray at room temperature.
■ The ISE module status must be ≥ 4 (module sleeping).
1. Press the ISE automatic maintenance button:
The ISE module automated maintenance screen is displayed.
The steps to be carried out during the maintenance are listed. The status of each step is indicated
by a color code:
■ Gray: The step must be performed.
■ Orange: The step is in progress.
■ Green: The step has successfully been completed.
■ Red: An error appeared during the step.
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2. Select an available rack position on the sample tray from the Rack and Pos. dropdown lists.
3. Put 200 µL of serum or plasma into a sample cup and place it in the selected rack position.
4. Press Next to launch step 1.
The instrument checks the following items:
■ the required solutions are present on the reagent and sample trays,
■ the required cleaners are active and there remains a sufficient volume.
Then, the ISE module drains the reagents from the electrodes.
If an error appears during the step, check and correct the error before launching again either the
step or the whole maintenance.
5. Wait for the end of step 1 and replace the chloride electrode with the ABX Pentra Dummy
Electrode A11A01851 as follows:
a. Open the ISE module cover.
b. Open the Faraday cage by loosening the fixing screw.
c. Replace the chloride electrode with the ABX Pentra Dummy Electrode A11A01851.
d. Close the Faraday cage by tightening the fixing screw.
e. Close the ISE module cover.
The ISE module is cleaned with the ABX Pentra Deproteinizer CP A11A01754. It takes a few
minutes.
7. Manually clean the chloride electrode as follows:
a. Use one thread provided in the Cleaning kit for Chloride electrode XEA935AS (1209159935).
b. Pull one thread only once slowly and carefully through the sample channel of the electrode in
the direction indicated below.
Do not wash and re-use the threads. They are designed for single use only.
c. Make sure that the O-ring is well-positioned on one side of the electrode.
8. Wait for the end of step 2 and replace the ABX Pentra Dummy Electrode A11A01851 with the
chloride electrode.
The following substeps are carried out:
■ the ISE module is cleaned with the ABX Pentra Etching CP A11A01769,
■ the ISE module activation is performed,
■ the ISE module rinses the fluidic system,
■ the 2-point calibration is performed.
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10. Wait for the end of step 3 and press the Quit button:
After the ISE module has been cleaned:

■ Remove the ABX Pentra Etching CP A11A01769 from the tray, close it and store it at room
temperature.
■ Remove the activator from the sample tray.
■ Check the ISE calibration results.
■ Check ISE tests with the appropriate control materials.
■ ISE Calibration Results, p.116
2.2.2. To Clean Needles and Mixer with Deproteinizer
Clean needles and mixer with the ABX Pentra Deproteinizer CP A11A01754 on a weekly
basis.
■ Consumables and spare parts: ABX Pentra Deproteinizer CP A11A01754

1. Choose the ABX Pentra Deproteinizer CP A11A01754 from the Needle Cleaning Solution
dropdown list.
2. Select the Mixer cleaning option.
3. Press Needle Cleaning to clean needles and mixer.
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Maintenance
2.3. Monthly Procedures
2.3.1. To Clean the Reagent Needle (External Part)
Clean the reagent needle (external part) on a monthly basis.
1. Press Replace Reagent needle.

The temperature regulation of the reagent needle is switched off and the reagent needle is
positioned so as to make its cleaning easier.
A dialog box asks you to replace the needle.

Reagent and sample needles are susceptible to cause ESD damage to the instrument
motherboard when they are handled without ESD safe handling tools. Make contact
with the instrument ground (cover screw for example) before proceeding on needles in
order to prevent electrostatic discharges.
2. Open the main cover.

3. Wipe the external part of the needle gently from top to bottom with a soft cloth slightly moistened
with distilled water.
4. Dry the needle external part with a soft cloth.
5. Close the main cover and press OK.
The reagent needle is positioned above its wash tower.
6. Open the main cover to make sure that the needle is centred above its wash tower.
If the reagent level detection is enabled, a dialog box informs you that the reagent level detection
will be automatically calibrated.
8. Press OK.
The reagent level detection is calibrated.
If the calibration fails, the alarm #157 Error card reagent detection [error code: message] is
triggered.
2.3.2. To Clean Wash Towers
Clean wash towers with ABX Pentra Deproteinizer CP A11A01754 on a monthly basis.
Consumables and spare parts: A cotton swab, ABX Pentra Deproteinizer CP A11A01754
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Maintenance
1. Press Clean wash tower.

The reagent and sample needles as well as the mixer are positioned so as to make the wash
towers cleaning easier.
A dialog box asks you to clean the wash towers.
3. Press the front of the optic hatch (1) to open it and lift the mixer up by pressing the red button (2).
1 = Front of the optic hatch

2 = Mixer red button
4. Clean the three wash towers (reagent and sample needles, mixer) with a cotton swab moistened
with ABX Pentra Deproteinizer CP A11A01754.
3 = Reagent needle wash tower

4 = Sample needle wash tower
5 = Mixer wash tower

5. Reassemble in reverse order and press OK.
6. Press Priming Cycle and make sure that the reagent and sample needles correctly dispense
distilled water for a few seconds in their respective wash towers.
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Maintenance
2.3.3. To Replace Syringe Plunger Tips
To ensure good pipetting precision, replace the syringe plunger tips on a monthly basis.
Consumables and spare parts: 1000 µL + 500 µL O'rings B8086583 (1228086583), 1000 µL Teflon
Seal B8086605 (1228086605), 100 µL Teflon Seal B8086648 (1228086648), Seal Replacement Tool
B8088454 (1228088454)
1. Press Replace syringe plunger tips.

The syringes are positioned halfway down so as to make the plunger tips replacement easier.
A dialog box asks you to replace the plunger tips.
3. Remove the reagent syringe (1) and the sample syringe (2) as follows:
a. Loosen the fixing screw.
b. Carefully unscrew the syringe to remove it.
c. Repeat steps a and b for each syringe.
1 = Reagent syringe
2 = Sample syringe
4. Replace the reagent syringe plunger tip as follows:
a. Remove the plunger from the glass barrel.
b. Pull off the tip as well as the O-ring.
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Maintenance
When removing the tip never bend the plunger.
c. Install a new O-ring and a new tip.

d. Carefully put the plunger back into the glass barrel.
3 = O-ring
4 = Tip
5. Replace the sample syringe plunger tip as follows:

a. Remove the plunger from the glass barrel.
b. Pull off the tip.
c. Put a new tip in the replacement tool, hold the plunger vertically and insert the tip.
5 = Tip
6 = Replacement tool
d. Carefully put the plunger back into the glass barrel.
6. Manually fill and empty each syringe with distilled water several times.
Ensure that each syringe is filled with water and that no air bubbles are visible in the syringe.
7. Reassemble the syringes in reverse order.
10. Calibrate the pressure detection of reagent and sample needles as follows:
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Maintenance
a. Press Reagent pressure calibration.

This function is unavailable if the pressure detection is disabled. Refer to the Settings > System
Configuration > Analyser > To Configure Pressure Detection chapter.
The reagent needle pressure detection is calibrated. The slope (A) and the intercept (B) of the
regression line y = A * x + B are displayed.
If the calibration fails, the slope (A) and the intercept (B) are displayed in red and the warning
#627 Pressure Reagent calibration failed is triggered.
b. Press Sample pressure calibration.
The sample needle pressure detection is calibrated. The slope (A) and the intercept (B) of the
#626 Pressure Sample calibration failed is triggered.
■ To Configure the Pressure Detection, p.304
2.3.4. Performing the Precision Test
Check the pipetting accuracy and precision once a month. Depending on the control
solution you have, follow either the To Perform the T1 Test procedure (ABX Pentra
Qualitest Solution A11A01758) or the To Perform the P1 Test procedure (ABX Pentra
Precitest Solution 1300017438).
2.3.4.1. To Perform the T1 Test
Follow this procedure to check pipetting accuracy and precision on a monthly basis.
■ Consumables and spare parts: ABX Pentra Qualitest Solution A11A01758

■ The ABX Pentra Qualitest Solution A11A01758 must be previously configured as a control for
the T1 test in Calibration/Control menu and placed in the configured position.
■ Two reagent vials of distilled water (15 mL and 10 mL) must be previously configured as a reagent
for the T1 test in the Reagent Configuration menu and placed on the reagent tray.
1. Order a calibration for the T1 test as follows:

a. Enter Main menu > Worklist > Calibration.
b. Press Add new.
c. Select the test T1 and press OK to validate.
2. Press Start.
4. If the calibration results are not automatically validated, refer to the Workflow > Calibration and
Control > Calibration and Control Results Validation > Calibration Results > To Validate a
Calibration chapter.
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5. Order a control for the T1 test as follows:

a. Enter Main menu > Worklist > Control.
b. Press Add new.
c. Select the ABX Pentra Qualitest Solution A11A01758 from the Control Selection area.
displayed.
d. Select the T1 test and configure 15 replicates by pressing the up or down arrows (right
side of the screen) to increase or to decrease the number of replicates.
e. Press OK to validate.
6. Press Start.
8. If the control results are not automatically validated, refer to the Workflow > Calibration and
Control > Calibration and Control Results Validation > Control Results > To Validate a Control
chapter.
9. Check the control results as follows:
a. Enter Main menu > Quality Control > Test.
b. Select the test T1 from the Select Test dropdown list.
The Session Mean table displays the statistical analyses over the current worklist for the T1
test.
c. Make sure that the session coefficient of variation (CV) is ≤ 1.0%.
If not, refer to the Troubleshooting > Sampling System > Reproducibility Problems chapter.
■ Reproducibility Problems, p.379
2.3.4.2. To Perform the P1 Test
Follow this procedure to check pipetting accuracy and precision on a monthly basis.
■ Consumables and spare parts: ABX Pentra Precitest Solution 1300017438

■ The ABX Pentra Precitest Solution 1300017438 must be previously configured as a control for
the P1 test (target value: 600 ΔA +/- 100) in the Calibration/Control menu and placed in the
configured position.
■ A reagent vial of distilled water (15 mL) must be previously configured as a reagent for the P1 test
in the Reagent Configuration menu and placed on the reagent tray.
1. Order a calibration for the P1 test as follows:

a. Enter Main menu > Worklist > Calibration.
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Maintenance
b. Press Add new.

c. Select the P1 test and press OK to validate.
2. Press Start.
4. If the calibration results are not automatically validated, refer to the Workflow > Calibration and
Control > Calibration and Control Results Validation > Calibration Results > To Validate a
Calibration chapter.
5. Order a control for the P1 test as follows:
a. Enter Main menu > Worklist > Control.
b. Press Add new.
c. Select the ABX Pentra Precitest Solution 1300017438 from the Control Selection area.
displayed.
d. Select the P1 test and configure 15 replicates by pressing the up or down arrows (right side of
the screen) to increase or to decrease the number of replicates.
e. Press OK to validate.
6. Press Start.
8. If the control results are not automatically validated, refer to the Workflow > Calibration and
Control > Calibration and Control Results Validation > Control Results > To Validate a Control
chapter.
9. Check the control results as follows:
a. Enter Main menu > Quality Control > Test.
b. Select the P1 test from the Select Test dropdown list.
The Session Mean table displays the statistical analyses over the current worklist for the P1
test.
c. Make sure that the session coefficient of variation (CV) is ≤ 1.0%.
If not, refer to the Troubleshooting > Sampling System > Reproducibility Problems chapter.
■ Reproducibility Problems, p.379
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Maintenance
2.3.5. To Clean the Cooling Unit Condenser
To maintain a good cooling capacity, clean the cooling unit condenser on a monthly basis.
Consumables and spare parts: A vacuum cleaner
1. Disable the cooling unit as follows:

a. Press Edit.
b. Deselect the Activate Cold Area check box.
2. Switch the cooling unit off and disconnect the power supply cable.
3. Pull the ventilation grid and remove it.
4. Remove dust from the condenser with a vacuum cleaner.
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Maintenance
5. Put the ventilation grid back.
When you close the ventilation grid, take care to arrange the drainage tube up as
indicated below.
6. Connect the power supply cable and switch the cooling unit on.
Wait ten minutes minimum, between switching off and switching on the cooling unit.
7. Enable the cooling unit as follows:

a. Press Edit.
b. Select the Activate Cold Area check box.
2.4. Bimonthly Procedures (Every Two Months)
2.4.1. To Check Glycol Level
Check the cooling unit glycol level on a bimonthly basis (every two months).
1. Make sure that the glycol level indicator is between the high and low marks.
2. If the glycol level indicator is below the low mark, follow steps 3 to 9 to add distilled water.
3. Disable the cooling unit as follows:
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Maintenance
a. Press Edit.
b. Deselect the Activate Cold Area check box.
4. Switch the cooling unit off and disconnect the power supply cable.
5. Slightly push to unlock and to open the lid as shown below.
6. Add distilled water until the glycol level indicator is between the high and low marks.
Take care that no liquid enters the cooling unit.
7. Close the lid.

8. Connect the power supply cable and switch the cooling unit on.
Wait ten minutes minimum, between switching off and switching on the cooling unit.
9. Enable the cooling unit as follows:

a. Press Edit.
b. Select the Activate Cold Area check box.
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Maintenance
2.4.2. To Replace Filter
Replace the filter at the back of the instrument on a bimonthly basis (every two months).
■ Consumables and spare parts: Liq. Elem + Gasket Ring Filter B8089078 (1228089078)
1. Unscrew the two tube clamps.
2. Tighten both parts of the filter assembly and unscrew to open it.
3. Replace the filter as well as the O-rings.

4. Reassemble the filter in reverse order.
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Maintenance
2.5. Other Procedures
2.5.1. To Replace Syringes
Follow this procedure to replace either the reagent syringe or the sample syringe or both.
Consumables and spare parts: Reagent Syringe (1000 µL) B8078955 (1228078955), Sample Syringe
(100 µL) B8076812 (1228076812)
1. Press Replace Syringe.

The syringes move halfway down so as to make their replacement easier.
A dialog box asks you to replace the syringe.
3. Remove the reagent syringe (1) and/or the sample syringe (2) as follows:
a. Loosen the fixing screw.
b. Carefully unscrew the syringe to remove it.
c. Repeat steps a and b for each syringe.
1 = Reagent syringe
2 = Sample syringe
4. Manually fill and empty each new syringe with distilled water several times.
Ensure that each syringe is filled with water and that no air bubbles are visible in the syringe.
5. Reassemble the new syringes in reverse order.
8. Calibrate the pressure detection of the reagent and sample needles as follows:
a. Press Reagent pressure calibration.
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Maintenance
#627 Pressure Reagent calibration failed is triggered.
b. Press Sample pressure calibration.
#626 Pressure Sample calibration failed is triggered.
2.5.2. To Replace Reagent Needle
Follow this procedure to replace the reagent needle.
Consumables and spare parts: Reagent Needle XBA564DT (1209119564)
1. Press Replace Reagent needle.

The temperature regulation of the reagent needle is switched off and the reagent needle is
positioned so as to make its replacement easier.


3. Remove the reagent arm cover by unscrewing the two screws.
4. Disconnect the reagent needle teflon tubing from the syringe block.
1 = Reagent needle teflon tubing

2 = Sample needle teflon tubing
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Maintenance
5. Unscrew the two plastic collars maintaining the reagent needle teflon tubing.
6. Disconnect the level detection cable and loosen the two screws to free the needle.
3 = Reagent needle screws

4 = Reagent level detection cable
7. Disconnect the reagent needle connector and remove the needle.
5 = Reagent needle connector

8. Replace the reagent needle and reassemble in reverse order.
The reagent needle is positioned above its wash tower.
If the reagent level detection is enabled, a dialog box informs you that the reagent level detection
will be automatically calibrated.
12. Press OK.
The reagent level detection is calibrated.
If the calibration fails, the alarm #157 Error card reagent detection [error code: message] is
triggered.
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Maintenance
14. Press Reagent pressure calibration.
If the calibration fails, the slope (A) and the intercept (B) are displayed in red and the warning #627
Pressure Reagent calibration failed is triggered.
2.5.3. To Replace the Sample Needle
Follow this procedure to replace the sample needle.
Consumables and spare parts: Sample Needle XBA847AT (1209119847)
1. Press Replace Sample needle.

The sample needle is positioned so as to make its replacement easier.


3. Remove the sample arm cover by unscrewing the two screws.
4. Disconnect the sample needle teflon tubing from the syringe block.
1 = Reagent needle teflon tubing

2 = Sample needle teflon tubing
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Maintenance
5. Unscrew the two plastic collars maintaining the sample needle teflon tubing.
6. Disconnect the level detection cable and loosen the screw to free the needle.
3 = Sample level detection cable

4 = Sample needle screw
7. Remove the needle.
8. Replace the sample needle and reassemble in reverse order.
■ Before the sample arm cover reassembly: position, as much as possible, the
sample needle locking screw towards the sample arm inside.
■ Take care that the tubing is correctly positioned in the sample arm cover and be
careful not to clamp the tubing nor the wires of the sample arm when you tighten
the screw on the sample arm cover.

The sample needle is positioned above its wash tower.
13. Press Sample pressure calibration.
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Maintenance
If the calibration fails, the slope (A) and the intercept (B) are displayed in red and the warning #626
Pressure Sample calibration failed is triggered.
2.5.4. To Replace the Mixer Paddle
Follow this procedure to replace the mixer paddle.
Consumables and spare parts: Mixer Paddle GBM0134 (1203600134)
1. Press Replace Mixer Paddle.

The reagent and sample needles as well as the mixer are positioned so as to make the mixer
paddle replacement easier.
A dialog box asks you to replace the mixer paddle.
3. Remove the mixer cover by unscrewing the three screws.
4. Lift the mixer up by pressing the red button.
5. Loosen the screw to free the mixer paddle and remove the mixer paddle by pulling it down.
1 = Mixer paddle screw

2 = Pull down
6. Replace the mixer paddle and reassemble in reverse order.
Make sure that the mixer paddle is pushed up to the maximum in its support.
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Maintenance
2.5.5. To Replace the Lamp
Follow this procedure to replace the lamp.
Consumables and spare parts: Lamp bulb GBM1326 (1203601326), Light Bulb Dismantling Allen
Key MAB086A (1207821086)
1. Press Replace Lamp.

The lamp is switched off and the reagent and sample needles are positioned so as to make the
lamp replacement easier.
A dialog box asks you to replace the lamp.
Warning! Hot surface

Risk of personal injury due to hot surfaces within the instrument. Wait for the lamp to
cool down before proceeding.

3. Press the front of the optic hatch to open it.
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Maintenance
4. Disconnect the lamp supply cable by pressing the clip and pulling it. Loosen the light lock screws
with the Light Bulb Dismantling Allen Key MAB086A (1207821086) and turn the light lock to
remove the lamp.
1 = Press
2 = Pull
3 = Light lock screws
5. Replace the lamp and reassemble in reverse order.
■ Do not touch the lamp with fingers. If necessary use a soft cloth.
■ When reassembling, ensure that the lamp is correctly positioned as indicated
above.

7. Press Back to exit the Customer Services menu.
The instrument turns to the "Emergency Stop" status.
8. Press Startup from the generic toolbar to initialize the instrument.
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2.5.6. To Replace ISE Reagents (Option)
Follow this procedure to replace ISE reagents every month.
■ Consumables and spare parts: ABX Pentra Standard 1 A11A01717, ABX Pentra Standard 2
A11A01718, ABX Pentra Reference 280 mL A11A01901
1. Open the ISE module cover.

2. Remove the straw from the empty reagent bottle.
3. Replace the empty reagent bottle with a new one.
4. Plunge the straw into the new reagent bottle.
5. Make sure that the tubing corresponds to the reagent.
■ L: low standard (ABX Pentra Standard 1 A11A01717),
■ H: high standard (ABX Pentra Standard 2 A11A01718),
■ R: reference (ABX Pentra Reference 280 mL A11A01901).
6. Close the ISE module cover.
7. If the reagent bottle you changed was completely empty, press Global Initialization.
2.5.7. To Replace Electrodes (Option)
Follow this procedure to replace the electrodes.
■ Consumables and spare parts: ABX Pentra Sodium-E A11A01738, ABX Pentra Chloride-E
A11A01739, ABX Pentra Potassium-E A11A01740 or ABX Pentra Reference-E A11A01741
■ The ISE module status must be ≥ 3 (mechanical part initialised).
1. Press Change electrode.

The ISE module drains the reagents from the electrodes.
3. Open the Faraday cage by loosening the fixing screw.
4. Remove the used electrode. If the reference electrode needs to be changed, disconnect the two
tubings.
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Maintenance
5. Unpack the new electrode.
■ Please note that the electrodes can be installed up to the date mentioned on the
packaging label.
■ After opening, the electrodes are stable for:
■ 12 months for the reference electrode,
■ 12 months for the sodium electrode,
■ 4 months for the chloride electrode,
■ 6 months for the potassium electrode.
6. For the reference electrode, remove the protection from one side of the electrode and disconnect
the tubing between the two connectors.
7. Make sure that the O-ring is well-positioned on one side of the electrode and make sure that the
electrode is clean.
8. Install the new electrode.
■ When facing the ISE module, the electrodes have to be positioned as follows (from
left to right): reference electrode > sodium electrode > chloride electrode >
potassium electrode > air sensor.
■ For the reference electrode, reconnect the two tubings as follows:
■ The tubing labeled U must be connected to the upper position of the reference
electrode.
■ The tubing labeled D must be connected to the lower position of the reference
electrode.
9. Close the Faraday cage by tightening the fixing screw.

11. Press Global Initialization.
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Maintenance
2.5.8. ISE Module Shutdown (Option)
2.5.8.1. To Shut Down the ISE Module Within 3 Days
Follow this procedure to shut down the ISE module within three days.

ISE reagents running dry can damage the electrodes.

Ensure that there is always enough ISE reagents to perform the ISE module calibrations.
1. If the ISE module status is not ≥ 3, press Global Initialization.

2. Press Shutdown.
The ISE module fills up the electrodes with the low standard and air in order to prevent the
reference solution contamination.
3. You can now switch the Pentra C400 off.
Refer to the Workflow > End of Day chapter.
■ End of Day, p.212
2.5.8.2. To Shut Down the ISE Module for Over 3 Days
Follow this procedure to shut down the ISE module for over three days.

1. If the ISE module status is not ≥ 3, press Global Initialization.

3. Remove the straws from the reagent bottles and wrap them in absorbent paper.
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Maintenance
4. Close the reagent bottles with caps.
After opening, ISE reagents are stable for one month if stored at 5 - 30°C and
protected from light.
5. Press Drain.
The ISE module drains the reagents from the fluidic system.
6. Plunge the straws into a distilled water bottle and press Fluidic Initialization.
The ISE module primes the distilled water in the fluidic system.
7. Remove the straws from the distilled water bottle and wrap them into absorbent paper.
8. Press Drain.
The ISE module drains the distilled water from the fluidic system.
9. You can now switch the Pentra C400 off.
Refer to the Workflow > End of Day chapter.
11. Remove the four electrodes as well as the air sensor. For the reference electrode, disconnect the
two tubings.
■ For the reference electrode, connect a tube filled with reference solution between the two
connectors and seal the inner tube with a cellophane tape.
■ For the sodium, chloride and potassium electrodes as well as for the air sensor, ensure there is
no liquid in the inner tube.
Store the electrodes in a dry and clean area in their original packaging.

■ End of Day, p.212
■ To Put the Electrodes Back after an ISE Module Shutdown, p.366
2.5.8.3. To Put the Electrodes Back after an ISE Module Shutdown
Follow this procedure to start up the ISE module after a shutdown exceeding three days.

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3. Install the four electrodes as well as the air sensor.
■ When facing the ISE module, the electrodes have to be positioned as follows (from
left to right): reference electrode > sodium electrode > chloride electrode >
potassium electrode > air sensor.
■ For the reference electrode, reconnect the two tubings as follows:
■ The tubing labeled U must be connected to the upper position of the reference
electrode.
■ The tubing labeled D must be connected to the lower position of the reference
electrode.

5. Plunge the straws into the reagent bottles.
6. Make sure that the tubing corresponds to the reagent.
■ L: low standard (ABX Pentra Standard 1 A11A01717),
■ H: high standard (ABX Pentra Standard 2 A11A01718),
■ R: reference (ABX Pentra Reference 280 mL A11A01901).
8. Perform a global initialization of the ISE module as follows:
a. Enter Main menu > Services > Customer Services > ISE.
9. Perform an ISE module activation.
■ To Shut Down the ISE Module for Over 3 Days, p.365
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Maintenance
2.5.9. To Decontaminate your Instrument
Follow this procedure to decontaminate your instrument considering the biological

environment.
■ Systematically use safety gloves when cleaning the device.

■ In case of liquid spillage, switch the instrument off.
■ Never use alcohol or disinfectant product* containing alcohol on painted covers.

■ Never use bleach.
■ Never use scrubbing sponge on any surfaces.
■ Never spill liquid onto any cover or external surfaces.
■ Never use any soaked material i.e. sponge, soft cloth, towel, etc. to clean/rinse
external surfaces.
* Disinfectant product must have the following microbiological properties:

■ Bactericidal
■ Fungicidal
■ Active on Aspergillus fumigatus
■ Active on Mycobacterium tuberculosis (BK)
■ Antiviral (HIV, HBV and rotavirus)
Product example recommended by HORIBA Medical: ANIOS detergent disinfectant; Wip’Anios.
See also the WHO (World Health Organization) guidelines: "Laboratory Biosafety
Manual, 3rd edition" for more information.
1. Wipe all dirty surfaces thoroughly.

2. Dry all the stainless steel parts with a soft cloth.
3. Wipe the touch screen gently.
4. Dry the touch screen with a soft cloth to remove any trace of moisture.
5. Clean the external part of the reagent needle by referring to the Maintenance > Monthly
Procedures > To Clean the Reagent Needle (External Part) chapter.
6. Clean the needles and the mixer with ABX Pentra Deproteinizer CP A11A01754 by referring to
the Maintenance > Weekly Procedures > To Clean Needles and Mixer with Deproteinizer chapter.
7. Perform a complete ISE module cleaning by referring to the Maintenance > Weekly Procedures >
To Clean the ISE Module chapter.
■ To Clean the Reagent Needle (External Part), p.344
■ To Clean Needles and Mixer with Deproteinizer, p.343
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Maintenance
2.6. Consumables and Spare Parts
The table below provides you with a complete list of consumables and spare parts that may be
needed on the instrument.
Consumables
Designation Reference
4 mL Nalgene Vials A11A01572
ABX Pentra Deproteinizer CP A11A01754
ABX Pentra Clean-Chem CP A11A01755
ABX Pentra Qualitest Solution A11A01758
ABX Pentra Precitest Solution 1300017438
Sample Cup - Blue A11A01765
Sample Cup - Green A11A01766
Sample Cup - White A11A01767
Sample Cup - Yellow A11A01768
ABX Pentra Clean-Chem 99 CP A11A01789
30/10 cassettes kit (x 6) A11A01922
10 mL Reag Cup B1034626
Cuvette Segments A11A01891
Sample Syringe (100 µL) B8076812 (1228076812)
Reagent Syringe (1000 µL) B8078955 (1228078955)
1000 µL + 500 µL O'rings B8086583 (1228086583)
1000 µL Teflon Seal B8086605 (1228086605)
100 µL Teflon Seal B8086648 (1228086648)
Seal Replacement Tool B8088454 (1228088454)
Liq. Elem + Gasket Ring Filter B8089078 (1228089078)
Mixer Paddle GBM0134 (1203600134)
Lamp bulb GBM1326 (1203601326)
Sample Rack Stickers - # 01 to 10 HAX0166 (1207230166)
Sample Cup Rack Stickers - # 41 to 50 HAX0170 (1207230170)
Calibrator Sample Rack Stickers - # 71 to 84 HAX0173 (1207230173)
Control Sample Rack Stickers - # 85 to 99 HAX0174 (1207230174)
Reagent Rack Stickers - # 60 to 69 HAX0175 (1207230175)
Reagent Rack Stickers - # 70 to 79 HAX0176 (1207230176)
Calibrator Reagent Rack Stickers - # 01 to 15 HAX0188 (1207230188)
Control Reagent Rack Stickers - # 30 to 44 HAX0190 (1207230190)
Control Reagent Rack Stickers - # 45 to 59 HAX0191 (1207230191)
Sticker, Reagent Rack P400 HAX0230 (1207230230)
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Maintenance
Sample Rack Stickers - # 01 to 10 (2 of 5 Int.) HAX0273 (1207230273)
Sample Rack Stickers - # 11 to 20 (2 of 5 Int.) HAX0274 (1207230274)
Sample Cup Rack Stickers - # 41 to 50 (2 of 5 Int.) HAX0277 (1207230277)
Calibrator Sample Rack Stickers - # 71 to 84 (2 of 5 Int.) HAX0280 (1207230280)
Control Sample Rack Stickers - # 85 to 99 (2 of 5 Int.) HAX0281 (1207230281)
PC400/P400 Open Cas. sticker sheet1 HAX0334 (1207230334)
PC400/P400 Open Cas. sticker sheet2 HAX0335 (1207230335)
Water Container LBH004A (1207791004)
Sample Cup Rack XDA805B (1209132805)
Reagent Rack + Adaptors XDA849A (1209131849)
Cal/Ctrl Reagent Rack + Adaptors XDA850A (1209131850)
Tube Adaptors XDA968A (1209131968)
Sample Rack + Adaptors XEA778CS (1209159778)
4 mL Vial Adaptors XEA780AS (1209159780)
10 mL Vial Adaptors XEA781AS (1209159781)
Sample Cup Adaptors XEA782AS (1209159782)
Waste Container XEA783AS (1209159783)
HAX0281 (1207230281).
Spare parts
Light Bulb Dismantling Allen Key MAB086A (1207821086)
Reagent Needle XBA564DT (1209119564)
Sample Needle XBA847AT (1209119847)
ISE consumables and spare parts
ABX Pentra Standard 1 A11A01717
ABX Pentra Standard 2 A11A01718
ABX Pentra Sodium-E A11A01738
ABX Pentra Chloride-E A11A01739
ABX Pentra Potassium-E A11A01740
ABX Pentra Reference-E A11A01741
ABX Pentra Etching CP A11A01769
ABX Pentra Dummy Electrode A11A01851
ABX Pentra Reference 280 mL A11A01901
Cleaning kit for Chloride electrode XEA935AS (1209159935)
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2.7.
User Manual
MONTH:
DAILY
DAY: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
ISE module activation (beginning of the day)
ISE module cleaning with Etching (shutdown if > 20 samples)
Needles cleaning with Deproteinizer (shutdown)
WEEKLY
WEEK:

ISE module cleaning (complete)
Needles and mixer cleaning with Deproteinizer
Maintenance Schedule
MONTHLY BIMONTHLY (every two months)
DATE DATE
Reagent needle cleaning (external part) Glycol level checking
Wash towers cleaning Filter replacement
Syringe plunger tips replacement
DATE CV (%)
Test T1/P1
Cooling unit condenser cleaning
ON REQUEST
DATE ISE reagents replacement DATE LOT #

Syringes replacement
Standard 1
Reagent needle replacement
Sample needle replacement Standard 2
Mixer paddle replacement Reference
Lamp replacement Electrodes replacement DATE LOT #
Instrument decontamination Reference
DATE VERSION Sodium
Applications update Chloride
Software update Potassium
371
Maintenance
Troubleshooting
3. Troubleshooting
This chapter provides instructions for solving problems that may occur when using the Pentra C400
analyzer.
If a mechanical or electrical problem is suspected, do not perform inspection of the

analyzer by yourself. Contact your HORIBA Medical representative.
3.1. Analyzer Power Problems
Follow this procedure if you have problems starting your analyzer.
1. Make sure the main switch, at the back of the analyzer is on (I).
2. Make sure the power cord is properly connected.
3. Make sure the instrument is receiving power from the wall outlet.
4. Check the main fuses:
a. Make sure the main switch, at the back of the instrument is off (0).
b. Unplug the power cable from the analyzer.
c. Pull out the fuse holder.
d. Check the two fuses.
e. If necessary replace the fuses by new ones provided in the accessory kit.
Use only slow-blow internal fuses having the following characteristics:

2 x T 6.3 A H 250 V (5x20 mm)
f. Put back the fuse holder.

g. Plug the power cable.
5. Switch the instrument on.
If the problem persists, please contact your local HORIBA Medical representative.
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Troubleshooting
3.2. Printer Operation Problems
Follow this procedure if the printer does not work.
1. Make sure that the printer power cord is properly connected.

2. Switch the printer on and off.
3. Check the paper feed.
4. Refer to your printer user manual.
3.3.1. Reagent Tray
3.3.1.1. Cassette or Rack Displayed in Red
Follow this procedure if you have a cassette or a rack displayed in red on the main menu.
1. If you have a solution (in a cassette or on a reagent rack) appearing in red:

a. Make sure that the solution is active.
If not, check if an identical solution is already active. In this case, you have to deactivate the
active solution before activating the new solution.
b. Make sure that the solution is neither absent nor empty.
c. Make sure that the solution has not expired.
d. Make sure that the solution is correctly registered in Main menu > Services > Application
Configuration > Reagents.
2. If you have a reagent rack appearing totally in red:
a. Make sure that the rack was previously configured in Main menu > Services > System
Configuration > Analyser.
b. Check if a rack having the same rack ID is placed on the reagent tray and remove it if
necessary.
3. If you have a calibrator/control reagent rack appearing in red:
a. Make sure that the rack was previously configured in Main menu > Services > System
b. Check if a rack having the same rack ID is placed on the reagent tray and remove it if
necessary.
c. Make sure that each calibrator/control configured on the rack is neither absent nor empty.
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Troubleshooting
d. Make sure that each calibrator/control configured on the rack has not expired.
■ To Activate a Cassette, p.223
■ To Activate an Open Cassette, p.226
■ To Activate a Reagent on a Reagent Rack, p.229
3.3.1.2. Cassette or Rack Not Displayed
Follow this procedure if you have a cassette or a rack not displayed on the main menu
whereas it is present on the reagent tray.
1. Make sure that the barcode label is well-positioned and not dirty.
2. The reagent barcode reader may be out of service.
Please contact your local HORIBA Medical representative.
3.3.1.3. Reagent Tray Cover Open
Follow this procedure if a warning or an alarm Reagent Door Open is triggered.
1. Make sure that the reagent tray cover is properly closed.

2. If not, close it properly.
3.3.1.4. Reagent Tray Temperature Problem
Follow this procedure if the warning #305 Reagent tray temperature exceeds limits or the
alarm #055 Refrigerated Compartment Temperature regulation failed is triggered. This
means that the temperature in the refrigerated area of the reagent tray is out of range or
the temperature regulation of the reagent tray is out of service.
1. Check the temperature in the refrigerated area of the reagent tray in Main menu > Services >
Customer Services > Analyser.
Expected value: 4°C - 10°C (39°F - 50°F)
2. Check the glycol level. Refer to the Maintenance > Bimonthly Procedures (Every Two Months) > To
Check Glycol Level chapter.
■ To Check Glycol Level, p.352
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Troubleshooting
3.3.2. Sample Tray
3.3.2.1. Rack Displayed in Red
Follow this procedure if you have a rack appearing totally in red on the main menu.
1. Check if a rack having the same rack number is placed on the sample tray.
2. Remove it if necessary.
3.3.2.2. Rack Not Displayed
Follow this procedure if you have a rack not displayed on the main menu whereas it is
present on the sample tray.
1. Make sure that the rack was previously configured in Main menu > Services > System
2. Make sure that the barcode label is well-positioned and not dirty.
3. Make sure that the barcode type of the label is configured in Main menu > Services > System
Configuration > Local Settings.
4. The sample barcode reader may be out of service.
■ To Configure Sample Barcode Reader, p.315
■ To Check the Sample Barcode Reader, p.376
3.3.2.3. Rack Wrongly Displayed
Follow this procedure if you have a rack displayed full on the main menu whereas it is
empty on the sample tray.
1. The sample tray may not be correctly adjusted.

2. The tube/cup detector or the sample barcode reader may not be correctly adjusted.
■ To Check the Sample Barcode Reader, p.376
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Troubleshooting
3.3.2.4. Sample Displayed in Red
Follow this procedure if you have a patient sample, a calibrator or a control displayed in
red on the main menu.
1. Make sure that the sample is not empty.

2. Make sure that the sample tube or the sample cup is not capped.
3. The sample needle may be clogged.
a. Check the sample.
b. Clean the sample needle. Refer to the Maintenance > Daily Procedures > To Clean Needles
with Deproteinizer chapter.
c. If the problem persists, replace the sample needle. Refer to the Maintenance > Other
Procedures > To Replace the Sample Needle chapter.
4. If you have a calibrator or a control appearing in red:
a. Make sure that the calibrator or the control is not absent.
b. Make sure that the calibrator or the control has not expired.
■ To Clean Needles with Deproteinizer, p.340
■ To Replace the Sample Needle, p.358
3.3.2.5. To Check the Sample Barcode Reader
Follow this procedure to make sure that the sample barcode reader works properly.
Access: Main menu > Services > Customer Services > Analyser
1 = Sample tray positions

2 = Rack positions
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Troubleshooting
1. Press Read to perform a barcode reading on the sample tray.

The Sample Tray area displays the following data:
■ For each sample tray position, when a rack is read, the rack number is indicated. "Nothing"
means that no rack is read in this position.
■ For each rack position, when a sample tube is read, the sample ID is indicated. "NO" means
that a sample tube is detected in this position but no barcode label is read.
2. Make sure that racks and sample tubes are correctly read.
Press a sample tray position (left side of the area) to display the corresponding rack
positions (right side of the area).
If the sample barcode reader does not work properly, please contact your local HORIBA Medical
representative.
3.3.2.6. To Check Correct Reading of a Barcode Label
Follow this procedure to make sure that the sample barcode reader correctly reads a
barcode label.
Access: Main menu > Services > Customer Services > Barcode
1. Select an available rack position on the sample tray from the Sector and Position spin boxes.
2. Place a sample tube with barcode at the selected rack position.
3. Press Polling.
■ The sample tube is positioned in front of the sample barcode reader.
■ The sample barcode reader starts continuous reading of the barcode label.
■ The barcode, the barcode type as well as the correct reading percentage are displayed. "No
code" means that no barcode label is read.
4. Press Stop to stop the continuous reading of the barcode label.
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Troubleshooting
If the sample barcode reader does not work properly, make sure that the barcode label is well-
positioned and that it is not dirty.
3.4. Sampling System
3.4.1. Syringe Problems
Follow this procedure if you have problems with the reagent syringe, the sample syringe or
both.
1. Make sure that no air bubbles are visible in the syringe.

2. If there are, prime the fluidic system as follows:
a. Enter Main menu > Services > Customer Services > Cycles.
b. Press Priming Cycle and make sure that the reagent and sample needles correctly dispense
3. If the problem persists, the syringe may be damaged. In this case, replace the syringe by referring
to the Maintenance > Other Procedures > To Replace Syringes chapter.
■ To Replace Syringes, p.355
3.4.2. Needle Problems
Follow this procedure if you have problems with the reagent needle, the sample needle or
both.
1. If you have problems with the reagent needle, this one may be damaged. In this case, replace the
reagent needle by referring to the Maintenance > Other Procedures > To Replace the Reagent
Needle chapter.
2. If you have problems with the sample needle, this one may be damaged. In this case, replace the
sample needle by referring to the Maintenance > Other Procedures > To Replace the Sample
Needle chapter.
■ To Replace Reagent Needle, p.356
■ To Replace the Sample Needle, p.358
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Troubleshooting
3.4.3. Reagent Needle Temperature Problem
Follow this procedure if the warning #124 Heating needle temperature exceeds limits or
the alarm #054 Heating Needle Temperature regulation failed is triggered. This means that
the reagent needle temperature is out of range or the temperature regulation of reagent
needle is out of service.
1. Check the reagent needle temperature in Main menu > Services > Customer Services >
Analyser.
Expected value: 37°C +/- 0.5°C (99°F +/- 0.9°F)
2. The temperature regulation of the reagent needle may be out of service.
3.4.4. Reproducibility Problems
Follow this procedure if you have a coefficient of variation (CV) > 1.0% when performing
the precision test (T1 or P1).
1. Make sure that no air bubbles are visible in the syringes.

2. If there are, prime the fluidic system as follows:
a. Enter Main menu > Services > Customer Services > Cycles.
b. Press Priming Cycle and make sure that the reagent and sample needles correctly dispense
3. If the problem persists, the syringe plunger tips may be replaced. Refer to the Maintenance >
Monthly Procedures > To Replace Syringe Plunger Tips.
4. If the problem persists, the syringes may be replaced. Refer to the Maintenance > Other
Procedures > To Replace Syringes chapter.
5. Perform the precision test (T1 or P1) to check pipetting accuracy and precision.
■ To Replace Syringe Plunger Tips, p.346
■ To Replace Syringes, p.355
■ Performing the Precision Test, p.348
User Manual 379

Troubleshooting
3.5. Analytical Module
3.5.1. Cuvette Changer
3.5.1.1. "Used Cuvette" Holder Missing
Follow this procedure if a warning or an alarm Used Cuvette Holder Missing is triggered.
1. The "used cuvette" holder may be absent.

2. Reinstall the holder.
3.5.1.2. "Used Cuvette" Holder Full
Follow this procedure if a warning or an alarm Used Cuvette Holder Full is triggered.

3. Make sure that the used cuvette sensor is not dirty and clean it if necessary.
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Troubleshooting
Disable the cuvette changer and manually load cuvettes by referring to the Cuvette Changer > To
Manually Load Cuvettes chapter.
3.5.1.3. "New Cuvette" Holder Empty
Follow this procedure if the warning #301 Cuvette Holder Empty is triggered.

reaction tray.
3. If the problem persits, the new cuvette sensor may be out of service.
3.5.1.4. Noise in the Reaction Tray
Follow this procedure if you hear noise in the reaction tray and if a warning or an alarm is
triggered.
The instrument must be in the "Emergency Stop" status.
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Troubleshooting
If not, press Stop and wait for the instrument to turn to "Emergency Stop" status.
A cuvette segment may not be correctly loaded in the reaction tray.
1. Pull the cuvettes hatch to remove it.

2. Open the reaction tray door.
Pinch point! Be careful not to trap your hands/fingers.

Be careful when loading/unloading cuvette segments in the reaction tray.
3. Manually turn the reaction tray and make sure that each cuvette segment is correctly loaded in the
reaction tray by pressing it down.
4. Close the reaction tray door.
5. Put the cuvettes hatch back.
3.5.1.5. To Check Cuvette Changer
Follow this procedure to make sure that the cuvette changer works properly.
1. Select the first position of the reaction tray from the Sector spin box.
2. Press Unload to unload a used cuvette segment from the first position of the reaction tray.
This function is unavailable if the "used cuvette" holder is full.
3. Press Load to load a new cuvette segment into the first position of the reaction tray.
This function is unavailable if the "new cuvette" holder is empty or if the used cuvette holder is full.
4. Make sure that there is no abnormal noise when loading/unloading cuvette segments in the
reaction tray.
5. Repeat steps 1 to 4 for each reaction tray position.
If the cuvette changer does not work properly, please contact your local HORIBA Medical
representative.
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Troubleshooting
3.5.1.6. To Manually Load Cuvettes
Follow this procedure if you have problems with the cuvette changer and you have to
disable it.
1. Disable the cuvette changer as follows:

a. Press Edit.
b. Deselect the Cuvette changer check box to disable the cuvette changer.
A dialog box asks you to manually load cuvettes whenever necessary.
2. Manually load and unload cuvettes in the reaction tray as follows:
a. Pull the cuvettes hatch to remove it.
b. Open the reaction tray door.

Be careful when loading/unloading cuvette segments in the reaction tray.
c. If necessary, unload the used cuvette segment from the reaction tray.
d. Load the new cuvette segment in the reaction tray.
■ Ensure that the cuvette segment is correctly loaded in the reaction tray by
pressing it down.
reaction tray.
e. Close the reaction tray door and press OK.

f. Repeat steps b to e for each cuvette segment.
g. Put the cuvettes hatch back.
User Manual 383

Troubleshooting
3.5.2. Reaction Tray
3.5.2.1. Reaction Tray Door Open
Follow this procedure if a warning or an alarm Manual Cuvette Loading Door Open is
triggered.
1. Pull the cuvettes hatch to remove it.

2. Make sure that the reaction tray door is properly closed.
3. If not, close it properly.
4. Put the cuvettes hatch back.
3.5.2.2. Reaction Tray Temperature Problem
Follow this procedure if the warning #123 Reaction tray temperature exceeds limits or the
alarm #053 Reaction Tray Temperature regulation failed is triggered. This means that the
reaction tray temperature is out of range or the temperature regulation of reaction tray is
out of service.
1. Check the reaction tray temperature in Main menu > Services > Customer Services > Analyser.
Expected value: 37°C +/- 0.2°C (99°F +/- 0.36°F)
2. Check the room temperature.
3. The temperature regulation of the reaction tray may be out of service.
3.5.3. Lamp and Spectrophotometer
3.5.3.1. Lamp Stability Problem
Follow this procedure if the alarm #505 Light stability Not OK or the alarm #517 Light
intensity out of range is triggered.
1. Check if the lamp is on as follows:

a. Open the main cover.
b. Press the front of the optic hatch to open it.
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Troubleshooting
c. Check if the lamp is on.

d. Put the optic hatch back and close the main cover.
2. If the lamp is off, replace the lamp. Refer to the Maintenance > Other Procedures > To Replace the
Lamp chapter.
■ To Replace the Lamp, p.361
3.5.3.2. To Check Spectrophotometer Gains
Follow this procedure to check the spectrophotometer gains for each wavelength.
Access: Main menu > Services > Customer Services > Analyser
Spectrophotometer gains are adjusted and checked for the fifteen wavelengths at each instrument
initialization.
1. Check the spectrophotometer gains for each wavelength from the Spectro Gain area.
Spectrophotometer gains are expressed in % and should be included between 1% and 95%.
■ If one of the gains is included between 95% and 98%, the warning #629 The lamp is dying, it is
still operational but you will need to change it soon. [wavelength nm / gain in % of Gain]. is
triggered. This means that spectrophotometer gains are reaching limits. You will have to
replace the lamp soon.
■ If one of the gains is < 1% or > 98%, the alarm #520 The lamp has failed the gain check.
[wavelength nm / gain in % of Gain] Please change the lamp. is triggered. This means that
spectrophotometer gains are out of range. You have to replace the lamp.
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Troubleshooting
2. To replace the lamp, refer to the Maintenance > Other Procedures > To Replace the Lamp chapter.
■ To Replace the Lamp, p.361
3.6. ISE Module (Option)
3.6.1. To Check the ISE Module Status and ISE Error Code from
Customer Services Menu
■ Check the ISE module status before a maintenance operation.

■ Check the ISE error code when you have the ISE Module Status button displayed in
red on the main menu.
1 = ISE module status code

2 = ISE module status message
3 = ISE error code
1. Check the ISE module status in the ISE Status area.
Code Message
000 Module not initialised
001 Module initialised
002 Module configured
003 Mechanical part initialised
004 Module sleeping
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Code Message
005 Fluidic part initialised
006 Module calibrated
2. If the ISE module status is lower than expected, press Global Initialization.
3. If you have the ISE Module Status button displayed in red on the main menu, check the ISE error
code which has been triggered in the ISE Status area.
For detailed information concerning ISE error codes, refer to the Alarms > ISE Error
Codes chapter.
4. In case of mechanical error on the ISE module, refer to the ISE Module (Option) > Mechanical Error
on the ISE Module chapter.
5. In case of reagent/fluidic error on the ISE module, refer to the ISE Module (Option) > Reagent/
Fluidic Error on the ISE Module chapter.
■ Mechanical Error on the ISE Module, p.387
■ Reagent/Fluidic Error on the ISE Module, p.387
3.6.2. Mechanical Error on the ISE Module
Follow this procedure if you have a mechanical error on the ISE module.
1. Press Global Initialization.

2. If the problem persists after several global initializations of the ISE module, please contact your
local HORIBA Medical representative.
3.6.3. Reagent/Fluidic Error on the ISE Module
Follow this procedure if you have a reagent/fluidic error on the ISE module.
1. Check the levels of the ISE reagents.
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Troubleshooting
a. If an ISE reagent needs to be replaced, refer to the Maintenance > Other Procedures > To
Replace ISE Reagents (Option) chapter.
2. If you have just replaced an electrode:
a. Make sure that you removed the protection on each side of the electrode.
b. If not, remove it and press Global Initialization.
c. Make sure that the O-ring is well-positioned on one side of the electrode, make sure that the
electrode is well-positioned by referring to the Maintenance > Other Procedures > To Replace
Electrodes (Option) chapter.
d. If not, reinstall the electrode and press Global Initialization.
3. If the ISE module has been shut down for a long period, salt-crystals may have formed.
a. Remove the electrodes by referring to the Maintenance > Other Procedures > To Replace
Electrodes (Option) chapter.
b. Clean the electrodes with distilled water.
c. Reinstall the electrodes and press Global Initialization.
4. If the problem persists after several global initializations of the ISE module, please contact your
local HORIBA Medical representative.
■ To Replace Electrodes (Option), p.363
3.6.4. Error on the ISE Calibration
Follow this procedure if you have the ISE Module Status button displayed in blue with a
red circle on the main menu. This indicates an error in the ISE calibration.
1. Make sure that the ISE module maintenance procedures have been performed on time.
If not, refer to the Maintenance > Daily Procedures > To Clean the ISE Module with Etching
(Option) chapter for daily maintenance or to Maintenance > Weekly Procedures > To Clean the ISE
Module chapter for weekly maintenance.
2. Check the volume and expiration date of Standard 1, Standard 2 and Reference bottles.
a. If an ISE reagent needs to be replaced, refer to the Maintenance > Other Procedures > To
Replace ISE Reagents (Option) chapter.
3. Make sure that the Reference bottle and the Standard 1 bottle are not inverted by referring to the
a. If necessary, put the bottles back in place.
4. An electrode may have expired.
a. Press the ISE Module Status button from the main menu.
The ISE calibration results screen is displayed.
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Troubleshooting
b. Check the ISE calibration results.
c. If the ISE calibration results are bad for one electrode, the concerned electrode may have
expired. Replace the concerned electrode by referring to the Maintenance > Other Procedures
> To Replace Electrodes (Option) chapter.
d. If the ISE calibration results are bad for all electrodes, the reference electrode may have
expired. Replace the reference electrode by referring to the Maintenance > Other Procedures >
To Replace Electrodes (Option) chapter.
5. If you have just replaced the electrodes, run successively five 2-point calibrations to stabilize the
electrodes.
Refer to the ISE Calibration (Option) > To Run an ISE Calibration chapter.
■ To Clean the ISE Module with Etching (Option), p.339
■ To Replace Electrodes (Option), p.363
■ To Run an ISE Calibration, p.115
3.7. Water and Waste Tanks
3.7.1. Water Tank Empty
Follow this procedure if the warning #610 Water Tank Empty is triggered.
1. Check the distilled water level in the tank.

2. Fill the tank if necessary.
3. If the water tank is full:
a. Make sure that the water tank sensor is not dirty and clean it if necessary.
b. The water tank sensor may be out of service.
3.7.2. Waste Tank Full
Follow this procedure if a Waste Tank Full warning is triggered.
1. Check the waste level in the tank.
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Troubleshooting
2. Empty the tank if necessary.

3. If the waste tank is empty:
a. Make sure that the waste tank sensor is not dirty and clean it if necessary.
b. The waste tank sensor may be out of service.
3.7.3. No Level Detection on Water and Waste Tanks
Follow this procedure if the water tank is empty or if the waste tank is full and no warning
is triggered.
1. If the water tank is empty and no warning is triggered:

a. Make sure that the water tank sensor is not dirty and clean it if necessary.
b. The water tank sensor may be out of service.
2. If the waste tank is full and no warning is triggered:
a. Make sure that the waste tank sensor is not dirty and clean it if necessary.
b. The waste tank sensor may be out of service.
3.8. Cooling Unit
3.8.1. Glycol Level Problem
Follow this procedure if the warning #307 Water level of the cold group is insufficient is
triggered.
1. Check the glycol level. Refer to the Maintenance > Bimonthly Procedures (Every Two Months) > To
Check Glycol Level chapter.
2. The glycol level sensor may be out of service.
■ To Check Glycol Level, p.352
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Troubleshooting
3.8.2. Compressor Overload
Follow this procedure if a warning or an alarm Compressor overload is triggered.
1. Make sure that the cooling unit is switched on.

2. Check the cooling unit connections at the back of the Pentra C400 and cooling unit.
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392
PROBLEM ACTION 3.9.
Troubleshooting
3.9.1.
Yes Yes Remove bubbles
Alarm on blank Reagent bubbles (reagent or diluent)
No No
Yes Check water quality

Fresh reagent Run T1/P1 and check
maintenance
Result Problems
No
Use new reagent
Calibration Results
Yes
Yes Yes No
Factor alarm Correct lot/target Fresh calibrator Use new calibrator
No No
Change lot/target
Yes
Deviation alarm Well-mixed calibrator
Yes
No No
Mix calibrator
Remove bubbles
Analytical alarm*
Yes
No
Run control
Follow this troubleshooting diagram if calibration results are flagged.
* Refer to Alarms > Analytical and Quality Flags > Analytical Flags chapter.

User Manual
User Manual
PROBLEM ACTION 3.9.2.
No
Analytical alarm* Run patient sample
Yes
Correct Yes Yes Yes Yes Correct configuration Yes Run T1/P1 and check
confidence range Same result on rerun New calibration New reagent of application maintenance
No No No No No

Check application
Control Results
Use new reagent
Rerun calibration
Well-mixed and Yes Enough volume Yes Run T1/P1 and check
reconstituted control in sample cup maintenance
No No
Use new sample cup
Mix control
Remove bubbles
Follow this troubleshooting diagram if control results are flagged.
Use new control
Check lot/target
* Refer to Alarms > Analytical and Quality Flags > Analytical Flags chapter.
393
Troubleshooting
394
PROBLEM ACTION
Troubleshooting
3.9.3.
Yes Yes Icteric, hemolytic, Yes Dilute manually 1/2

Analytical alarm* Sample limit alarm lactescent sample or 1/3
No No No
Rerun sample
Yes Correct configuration Yes Correct sample type Yes Yes Check patient history
Same result on rerun of application (serum, plasma) Control ok
to validate
Patient Results
No No No No
Rerun control,
calibration
Refer to reagent
notice
Check application
Yes Yes Enough volume Yes Run T1/P1 and check

Repeatability problem Sample without fibrin in sample tube maintenance
No No No
Transfer sample
in sample cup
Follow this troubleshooting diagram if patient results are flagged.
Centrifuge correctly
Remove bubbles,
fibrin
Check patient history

to validate
* Refer to the Alarms > Analytical and Quality Flags > Analytical Flags chapter.

User Manual
User Manual
PROBLEM ACTION 3.9.4.
No
ISE control problem Run patient sample
Yes
Correct Yes Yes Correct configuration Yes Yes Change reference

confidence range Same result on rerun of application Problem on all ISE electrode
No No No No Perform ISE module

maintenance
Change concerned
electrode
Check ISE application
Well-mixed and Yes Enough volume Yes Run T1/P1 and check
reconstituted control in sample cup maintenance
ISE Control Results (Option)
No No
Use new sample cup
Before any investigation, check the following items:
Mix control
Remove bubbles
Use new control
Check lot/target
Follow this troubleshooting diagram if ISE control results are flagged.
■ ISE module maintenance procedures have been performed on time.

■ volume and expiration date of Standard 1, Standard 2 and Reference bottles,
395
Troubleshooting
Troubleshooting
3.9.5. ISE Patient Results (Option)
Follow this troubleshooting diagram if ISE patient results are flagged.
Before any investigation, check the following items:

■ volume and expiration date of Standard 1, Standard 2 and Reference bottles,
■ ISE module maintenance procedures have been performed on time.
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PROBLEM ACTION
ISE patient sample Yes Yes Correct configuration Yes Correct sample type Yes Yes Check patient history
problem Same result on rerun of application (serum, plasma) Control ok
to validate
No No No No No
Refer to ISE control
problem
Refer to ISE notice

Check ISE application
Yes Enough volume Yes Run T1/P1 and check

Sample without fibrin in sample tube maintenance
No No
Transfer sample
in sample cup
Centrifuge correctly
Remove bubbles,
fibrin
Check patient history

to validate
397
Troubleshooting
Troubleshooting
398 User Manual

Alarms
1. System Warnings and Alarms....................................................................................... 400

1.1. System Warnings Overview....................................................................................................... 400
1.2. Warnings and Alarms................................................................................................................. 401
1.3. Additional Information................................................................................................................ 417
2. Sampling Alarms................................................................................................................. 420
3. Analytical and Quality Flags........................................................................................... 423

3.1. Analytical Flags.......................................................................................................................... 423
3.2. Quality Flags.............................................................................................................................. 444
3.3. ISE Analytical Flags (Option)...................................................................................................... 445
4. ISE Error Codes................................................................................................................... 448
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Alarms
System Warnings and Alarms
1. System Warnings and Alarms
1.1. System Warnings Overview
Access: Main menu > System Warnings
The System Warnings menu lists the system warnings and alarms as well as the maintenance alerts
that are triggered during instrument operation.
The System Warnings button becomes:

■ Red triangle when a system warning or a system alarm is triggered,
■ Red exclamation mark when a maintenance alert is triggered.

■ All
■ Warning
■ Alarm
■ Alert
All, Warning and Alarm tabs
The All tab displays the system warnings and alarms that are triggered.
The system warnings and alarms are sorted by date and are listed in a table format which indicates
the event level (warning or alarm), the event date and time, the event code and message.
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Alarms
You can display either the system warnings or the system alarms, or both by pressing Warning,
Alarm or All tab.
For detailed information on system warnings and alarms, refer to the System Warnings
and Alarms > Warnings and Alarms chapter.
Alert tab
The Alert tab displays the maintenance procedures that must be performed on your instrument.
These procedures must be configured in Main menu > Services > System Configuration >
Maintenance.
The maintenance procedures are sorted by frequency and are listed in a table format which indicates
the procedure name and frequency, when the procedure must be performed. If a maintenance
procedure is not performed on time, a maintenance alert is triggered and indicated by a red
exclamation mark.
■ Configuring Maintenance Alerts, p.329
■ Warnings and Alarms, p.401
1.2. Warnings and Alarms
The table below lists the system warnings and alarms that can appear during instrument operation.
When a system warning or a system alarm is triggered, the System Warnings button becomes red
until you press it to open the System Warnings menu.
■ System warnings do not block the instrument and are displayed to warn the user. When a warning
is triggered, the instrument is not stopped and turns to "Ready" status.
■ System alarms block the instrument. When an alarm is triggered, the instrument is stopped and
turns to "Emergency Stop" status.
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Alarms
When a system warning or a system alarm is triggered, follow the instructions given in the table
below.
1.2.1. Warnings and Alarms from #001 to #100
Code Level Message Description Action

001 Warning ISE Module Initialization ISE module initialization failed Shutdown the instrument.
Problem Switch the instrument off and
on.
002 Alarm Sample Barcode Reader Sample barcode reader Run an initialization.
Initialization Problem initialization failed
003 Alarm Reagent Barcode Reader Reagent barcode reader Run an initialization.
004 Alarm Temperature Regulation Temperature regulation Run an initialization.
005 Alarm Measurement Module Measurement module Run an initialization.
006 Alarm Sample Vertical Motor Sample arm vertical motor Run an initialization.
007 Alarm Sample Rotation Motor Sample arm rotation motor Run an initialization.
008 Alarm Reagent Vertical Motor Reagent arm vertical motor Run an initialization.
009 Alarm Reagent Rotation Motor Reagent arm rotation motor Run an initialization.
010 Alarm Sample Tray Motor Sample tray motor Run an initialization.
011 Alarm Reagent Tray Motor Reagent tray motor Run an initialization.
012 Alarm Reaction Tray Motor Reaction tray motor Run an initialization.
013 Alarm Mixer Initialization Problem Mixer initialization failed Run an initialization.
014 Alarm Sample Syringe Motor Sample syringe motor Run an initialization.
015 Alarm Reagent Syringe Motor Reagent syringe motor Run an initialization.
016 Alarm Cuvette Vertical Motor Cuvette changer vertical Run an initialization.
Initialization Problem motor initialization failed
017 Alarm Cuvette Horizontal Motor Cuvette changer horizontal Run an initialization.
Initialisation Problem motor initialization failed
018 Alarm Cuvette Motion Initialisation Cuvette motion motor Run an initialization.
Problem initialization failed
019 Alarm Sample Vertical Motor The sample arm vertical home Run an initialization.
Reference Position Error position is not reached on
time during the initialization.
020 Alarm Sample Rotation Motor The sample arm rotation Run an initialization.
Reference Position Error home position is not reached
on time during the
initialization.
021 Alarm Reagent Vertical Motor The reagent arm vertical home Run an initialization.
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Alarms

022 Alarm Reagent Rotation Motor The reagent arm rotation Run an initialization.
on time during the
initialization.
023 Alarm Sample Tray Motor Reference The sample tray home Run an initialization.
Position Error position is not reached on
024 Alarm Reagent Tray Motor The reagent tray home Run an initialization.
025 Alarm Reaction Tray Motor The reaction tray home Run an initialization.
026 Alarm Mixer Initialization Problem The mixer home position is Run an initialization.
not reached on time during
the initialization.
027 Alarm Sample Syringe Motor The sample syringe home Run an initialization.
028 Alarm Reagent Syringe Reference The reagent syringe home Run an initialization.
Position Error position is not reached on
029 Alarm Cuvette Vertical Motor The cuvette changer vertical Run an initialization.
on time during the
initialization.
030 Alarm Cuvette Horizontal Motor The cuvette changer Run an initialization.
Reference Position Error horizontal home position is
not reached on time during
the initialization.
031 Alarm Cuvette Motion Position Error The cuvette motion home Run an initialization.
position is not reached on
032 Alarm Sample Vertical Position Error The sample arm vertical home Run an initialization.
position is not reached with
the acceptable motor number
of steps during the
initialization.
033 Alarm Sample Rotation Position The sample arm rotation Run an initialization.
Error home position is not reached
with the acceptable motor
number of steps during the
initialization.
034 Alarm Reagent Vertical Motor The reagent arm vertical home Run an initialization.
Position Error position is not reached with
of steps during the
initialization.
035 Alarm Reagent Rotation Motor The reagent arm rotation Run an initialization.
Position Error home position is not reached
initialization.
036 Alarm Sample Tray Position Error The sample tray home Run an initialization.
of steps during the
initialization.
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Alarms

037 Alarm Reagent Tray Position Error The reagent tray home Run an initialization.
of steps during the
initialization.
038 Alarm Reaction Tray Position Error The reaction tray home Run an initialization.
of steps during the
initialization.
039 Alarm Mixer Position Error The mixer home position is Run an initialization.
not reached with the
acceptable motor number of
steps during the initialization.
040 Alarm Sample Syringe Position Error The sample syringe home Run an initialization.
of steps during the
initialization.
041 Alarm Reagent Syringe Position The reagent syringe home Run an initialization.
Error position is not reached with
of steps during the
initialization.
initialization.
Position Error horizontal home position is
not reached with the
acceptable motor number of
steps during the initialization.
044 Alarm Cuvette Changer Problem: The cuvette motion home Run an initialization.
Moving Forward position is not reached with
of steps during the
initialization.
045 Alarm Shock Detection Stop Sample arm shock detection Run an initialization.
during the initialization.
046 Alarm Shock Detection Out of Sample arm shock detection Run an initialization.
Service during the initialization.
047 Alarm Sample Level Detection Error Sample level detection error Check the solution level.
during pipetting in the reagent
tray at the instrument
shutdown.
048 Alarm Reagent Level Detection Error Reagent level detection error Check the solution level.
tray at the instrument
shutdown.
053 Alarm Reaction Tray Temperature Reaction tray temperature out Run an initialization.
regulation failed of range
Refer to the System Warnings
and Alarms > Additional
Information > Temperature
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Alarms

054 Alarm Heating Needle Temperature Reagent needle temperature Run an initialization.
regulation failed out of range
055 Alarm Refrigerated Compartment Temperature in the Run an initialization and
Temperature regulation failed refrigerated area of reagent restart the cooling unit.
tray out of range Check the cooling unit glycol
Refer to the System Warnings level.
056 Alarm Measurement Module Out of Measurement module out of Run an initialization.
Service service
Service service
058 Alarm Sample Tray Identification Sample barcode reader Shutdown the instrument.
Failure initialization failed Switch the instrument off and
on.
059 Alarm Reagent Tray Identification Reagent barcode reader Shutdown the instrument.
Failure initialization failed Switch the instrument off and
on.
060 Warning Non recoverable material error ISE module error Shutdown the instrument.
on the ISE module Switch the instrument off and
on.
061 Warning ISE command invalid The ordered ISE cycle cannot Shutdown the instrument.
be performed. Switch the instrument off and
on.
062 Alarm Main Cover Open Main cover open Close the main cover.
Run an initialization.
063 Alarm Reagent Door Open Reagent tray cover open Close the reagent tray cover.
065 Alarm Mixer not Positioned Mixer absent Push the mixer down.
066 Alarm Low pressure on the Sample Water supply defective during Check the distilled water level
or Reagent hydraulic system the initialization. in the tank. Fill the tank if
necessary.
Check the fluidic system.
067 Alarm No Clean Cuvettes Present "New cuvette" holder empty Add cuvette segments.
■ Temperature Warnings and Alarms, p.417

101 Alarm Sample Vertical Position Error The sample arm vertical home Run an initialization.
time during a run.
102 Alarm Sample Rotation Position The sample arm rotation Run an initialization.
on time during a run.
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Alarms

103 Alarm Reagent Vertical Position The reagent arm vertical home Run an initialization.
Error position is not reached on
time during a run.
104 Alarm Reagent Rotation Position The reagent arm rotation Run an initialization.
105 Alarm Sample Tray Position Error The sample tray home Run an initialization.
time during a run.
106 Alarm Reagent Tray Position Error The reagent tray home Run an initialization.
time during a run.
107 Alarm Reaction Tray Position Error The reaction tray home Run an initialization.
time during a run.
108 Alarm Mixer Position Error The mixer home position is Run an initialization.
not reached on time during a
run.
109 Alarm Sample Syringe Position Error The sample syringe home Run an initialization.
time during a run.
110 Alarm Reagent Syringe Position The reagent syringe home Run an initialization.
Error position is not reached on
time during a run.
Position Error horizontal home position is
not reached on time during a
run.
113 Alarm Cuvette Changer Problem: The cuvette motion home Run an initialization.
Moving Forward position is not reached on
time during a run.
114 Alarm Low pressure on the Sample Water supply defective during Check the distilled water level
or Reagent hydraulic system a run. in the tank. Fill the tank if
necessary.
115 Alarm Main Cover Open Main cover open Close the main cover.
116 Alarm Manual Cuvette Loading Door Reaction tray door open Close the reaction tray door.
Open Run an initialization.
117 Alarm Used Cuvette Holder Missing "Used cuvette" holder absent Reinstall the holder.
118 Alarm Sample Identification Failure Sample identification failed Check racks and sample
tubes.
119 Alarm Reagent Identification Failure Reagent identification failed Check cassettes and racks.
Service service
123 Warning Reaction tray temperature Reaction tray temperature out Run an initialization.
exceeds limits of range
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Alarms

124 Warning Heating needle temperature Reagent needle temperature Run an initialization.
exceeds limits out of range
Service during a run.
126 Alarm Sample Level Detection Out of Sample level detection error Check the solution or sample
Service three consecutive times level.
during pipetting in reagent or Run an initialization.
sample tray.
127 Alarm Sample Level Detection Out of Air detection two consecutive Check the solution or sample
Service times during the sampling. (level, air bubble, foam).
Make sure that no air bubbles
are visible in the syringe.
Calibrate the sample needle
pressure detection.
128 Alarm Reagent Level Detection Out Reagent level detection error Check the solution level.
of Service three consecutive times Run an initialization.
tray.
129 Alarm Reagent Level Detection Out Air detection two consecutive Check the solution (level, air
of Service times during the sampling. bubble, foam).
Make sure that no air bubbles
are visible in the syringe.
Calibrate the reagent needle
pressure detection.
130 Alarm Over pressure on the sample High pressure on the sample Make sure that the sample
hydraulic system fluidic system needle is not clogged and
clean it if necessary.
131 Alarm Over pressure on the reagent High pressure on the reagent Make sure that the reagent
132 Alarm Sample Needle Clogged Clog detection two Check the solution or sample.
consecutive times during the Make sure that the sample
sampling. needle is not clogged and
Calibrate the sample needle
pressure detection.
133 Alarm Reagent needle clogged Clog detection two Check the solution.
consecutive times during the Make sure that the reagent
sampling. needle is not clogged and
Calibrate the reagent needle
pressure detection.
Service during a run.
135 Alarm Maximum quantity of cycles Number of cycles Contact your local
exceeded incompatible with the HORIBA Medical
embedded software version. representative.
136 Alarm Peripheral busy [peripheral Incompatible cycle, time out Run an initialization.
number] on a motor.
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Alarms

137 Alarm Unknown Cycle The requested cycle does not Contact your local
exist. HORIBA Medical
representative.
138 Alarm Manual Cuvette Loading Reaction tray door open Close the reaction tray door.
Cover Open Run an initialization.
139 Alarm Used Cuvette Holder Missing "Used cuvette" holder absent Reinstall the holder.
140 Alarm Used Cuvette Holder Full "Used cuvette" holder full Discard the cuvette segments.
141 Alarm Reaction Tray Temperature Temperature sensor of the Run an initialization.
Sensor Out of Order reaction tray out of service
142 Alarm Reagent Needle Temperature Temperature sensor of the Run an initialization.
Sensor Out of Order reagent needle out of service
145 Alarm Reagent Tray Temperature Temperature sensor of the Run an initialization.
Sensor Out of Order reagent tray out of service
146 Alarm Shock Detection on Sample arm shock detection Run an initialization.
dispensing during dispensing.
147 Alarm Compressor overload: The cooling unit is stopped. Make sure that the cooling
Refrigeration has been Refer to the System Warnings unit is switched on.
stopped and Alarms > Additional Check the cooling unit
Information > Compressor connections.
Overload Alarm chapter.
148 Alarm Reagent Door Open Reagent tray cover open Close the reagent tray cover.
149 Alarm Over pressure on the sample High pressure on the sample Make sure that the sample
150 Alarm Over pressure on the reagent High pressure on the reagent Make sure that the reagent
151 Alarm Pressure controller Pressure detection Run an initialization.
initialization error initialization failed
152 Alarm Water Tank Low Level Insufficient distilled water level Check the distilled water level
in the tank. Fill the tank if
necessary.
153 Alarm Pressure controller of sample Air detection two consecutive Run an initialization.
arm out of order times during the sampling.
154 Alarm Pressure controller of reagent Air detection two consecutive Run an initialization.
arm out of order times during the sampling.
156 Alarm Mixer not Positioned Mixer absent Push the mixer down.
157 Alarm Error card reagent detection Error on the reagent level Refer to the System Warnings
[error code: message] detection board and Alarms > Additional
Information > Reagent Level
Detection Board Errors
chapter.
■ Temperature Warnings and Alarms, p.417
■ Compressor Overload Alarm, p.417
■ Reagent Level Detection Board Errors, p.418
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Alarms

301 Warning Cuvette Holder Empty "New cuvette" holder empty Add cuvette segments.
302 Warning Used Cuvette Holder Full "Used cuvette" holder full Discard the cuvette segments.
303 Warning Water Tank Low Level Insufficient distilled water level Check the distilled water level
necessary.
304 Warning Waste Tank Full Waste tank full Check the waste level in the
tank. Empty the tank if
necessary.
305 Warning Reagent tray temperature Temperature in the Run an initialization and
exceeds limits refrigerated area of the restart the cooling unit.
reagent tray out of range Check the cooling unit glycol
Refer to the System Warnings level.
307 Warning Water level of the cold group Insufficient cooling unit glycol Check the cooling unit glycol
is insufficient level level.
308 Warning Power supply problem Power supply problem Contact your local
HORIBA Medical
representative.
309 Warning SOLUTION_EMPTY/SN on The sampling alarm Check the solution and
liquid [solution name] SOLUTION_EMPTY/SN has replace it if necessary.
been triggered on the solution Activate the solution in the
in brackets during the Reagent Configuration
shutdown. menu.
Rerun the shutdown.
310 Warning SOLUTION_EMPTY/RN on The sampling alarm Check the solution and
liquid [solution name] SOLUTION_EMPTY/RN has replace it if necessary.
shutdown. menu.
Rerun the shutdown.
311 Warning SOLUTION_FOAM/SN on The sampling alarm Check the solution and
liquid [solution name] SOLUTION_FOAM/SN has replace it if necessary.
shutdown. menu.
Rerun the shutdown.
312 Warning SOLUTION_FOAM/RN on The sampling alarm Check the solution and
liquid [solution name] SOLUTION_FOAM/RN has replace it if necessary.
shutdown. menu.
Rerun the shutdown.
313 Warning SOLUTION_CLOGGING/SN The sampling alarm Check the sample needle and
on liquid [solution name] SOLUTION_CLOGGING/SN the teflon tubing.
has been triggered on the Calibrate the sample needle
solution in brackets during the pressure detection.
shutdown. Check the solution and
replace it if necessary.
Activate the solution in the
menu.
Rerun the shutdown.
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Alarms

314 Warning SOLUTION_CLOGGING/RN The sampling alarm Check the reagent needle and
on liquid [solution name] SOLUTION_CLOGGING/RN the teflon tubing.
has been triggered on the Calibrate the reagent needle
solution in brackets during the pressure detection.
shutdown. Check the solution and
replace it if necessary.
Activate the solution in the
menu.
Rerun the shutdown.
315 Warning SOLUTION_SHOCK on liquid The sampling alarm Check the solution and
[solution name] SOLUTION_SHOCK has been remove the caps if necessary.
triggered on the solution in Activate the solution in the
brackets during the shutdown. Reagent Configuration
menu.
Rerun the shutdown.
316 Warning INC_SOLUTION_PIPET/SN on The sampling alarm Check the solution and
liquid [solution name] INC_SOLUTION_PIPET/SN replace it if necessary.
has been triggered on the Activate the solution in the
solution in brackets during the Reagent Configuration
shutdown. menu.
Rerun the shutdown.
317 Warning INC_SOLUTION_PIPET/RN on The sampling alarm Check the solution and
liquid [solution name] INC_SOLUTION_PIPET/RN replace it if necessary.
has been triggered on the Activate the solution in the
solution in brackets during the Reagent Configuration
shutdown. menu.
Rerun the shutdown.
318 Warning Timeout error on ISE syringe 1 ISE module mechanical error. Perform a global initialization
(error code 1) ISE syringe 1 assy (Standard of the ISE module.
1/waste) home position is not
reached on time.
319 Warning Position error on ISE syringe 1 ISE module mechanical error. Perform a global initialization
(error code 2) ISE syringe 1 assy (Standard of the ISE module.
1/waste) home position is not
reached.
320 Warning Timeout error on ISE syringe 2 ISE module mechanical error. Perform a global initialization
(error code 11) ISE syringe 2 assy (Reference/ of the ISE module.
Standard 2) home position is
not reached on time.
321 Warning Position error on ISE syringe 2 ISE module mechanical error. Perform a global initialization
(error code 12) ISE syringe 2 assy (Reference/ of the ISE module.
Standard 2) home position is
not reached.
322 Warning Can't detect ISE low solution ISE module reagent/fluidic Check the Standard 1 bottle
(error code 21) error. and the fluidic system.
Air sensor cannot detect Perform a global initialization
Standard 1. of the ISE module.
323 Warning Can't detect ISE low solution ISE module reagent/fluidic Check the Standard 1 bottle
inlet (error code 22) error. and the fluidic system.
Air sensor cannot detect the Perform a global initialization
arriving of Standard 1. of the ISE module.
324 Warning Too much ISE low solution ISE module reagent/fluidic Check the Standard 1 bottle
Air sensor detects Standard 1. Perform a global initialization
of the ISE module.
325 Warning ISE low solution inlet excess ISE module reagent/fluidic Check the Standard 1 bottle
on timeout (error code 24) error. and the fluidic system.
Air sensor still detects Perform a global initialization
Standard 1 flow after the of the ISE module.
specified time of aspiration.
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Alarms

326 Warning ISE low solution inlet excess ISE module reagent/fluidic Check the Standard 1 bottle
on start of measuring (error error. and the fluidic system.
code 25) Air sensor detects Standard 1 Perform a global initialization
at the beginning of of the ISE module.
measurement.
327 Warning Can't detect ISE high solution ISE module reagent/fluidic Check the Standard 2 bottle
(error code 31) error. and the fluidic system.
Air sensor cannot detect Perform a global initialization
Standard 2. of the ISE module.
328 Warning Can't detect ISE high solution ISE module reagent/fluidic Check the Standard 2 bottle
Air sensor cannot detect the Perform a global initialization
arriving of Standard 2. of the ISE module.
329 Warning Too much ISE high solution ISE module reagent/fluidic Check the Standard 2 bottle
Air sensor detects Standard 2. Perform a global initialization
of the ISE module.
330 Warning ISE high solution inlet excess ISE module reagent/fluidic Check the Standard 2 bottle
on timeout (error code 34) error. and the fluidic system.
Air sensor still detects Perform a global initialization
Standard 2 flow after the of the ISE module.
specified time of aspiration.
331 Warning Can't detect ISE sample (error ISE module reagent/fluidic Make sure that there is no
code 41) error. fibrin clot in the sample.
Air sensor cannot detect Check the sample needle and
sample. the teflon tubing.
332 Warning Can't detect ISE sample inlet ISE module reagent/fluidic Make sure that there is no
(error code 42) error. fibrin clot in the sample.
Air sensor cannot detect the Check the sample needle and
arriving of sample. the teflon tubing.
333 Warning Too much ISE sample inlet ISE module reagent/fluidic Check the fluidic system.
(error code 43) error. Perform a global initialization
Air sensor detects sample. of the ISE module.
334 Warning ISE sample inlet excess on ISE module reagent/fluidic Check the fluidic system.
timeout (error code 44) error. Perform a global initialization
Air sensor still detects sample of the ISE module.
flow after the specified time of
aspiration.
335 Warning ISE electrode [electrode The difference between the Run a 2-point calibration.
name] sensibility error for [low low and high standard values Perform the ISE module
or high standard value] point is out of the sensitivity normal maintenance. Change the
(error code 50) range for the electrode in concerned electrode.
brackets.
336 Warning ISE electrode [electrode The low or high standard Run a 2-point calibration.
name] offset error for [low or value is out of the acceptable Perform the ISE module
high standard value] point range for the electrode in maintenance. Change the
(error code 51) brackets. concerned electrode.
337 Warning ISE electrode [electrode Repeatability error on the low Make sure that there are no
name] repeatability error for standard value for the air bubbles in the Standard 1
[low or high standard value] electrode in brackets. bottle. Change the Standard 1
point (error code 52) bottle. Perform the ISE
module maintenance. Change
the concerned electrode.
Check the spring contact of
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Alarms

338 Warning ISE electrode [electrode The potential difference during Make sure that there are no
name] response error for [low the three last seconds of a air bubbles in the Standard 1
or high standard value] point measurement is ≥ 0.40 mV for or Standard 2 bottle. Change
(error code 55) the electrode in brackets. the Standard 1 or Standard 2
bottle. Perform the ISE
module maintenance. Change
Check the spring contact of
339 Warning ISE LB check response error ISE module mechanical error. Perform a global initialization
(error code 91) of the ISE module.
340 Warning Compressor overload: The cooling unit is stopped for Make sure that the cooling
Refrigeration is stopped ten minutes and automatically unit is switched on.
temporarily for 10 minutes restarted after ten minutes Check the cooling unit
stopping. connections.
Information > Compressor
Overload Alarm chapter.
■ ISE Error Codes, p.448
■ Compressor Overload Alarm, p.417

501 Alarm Database version [version Bad database version Contact your local
number] Not OK, version HORIBA Medical
required [version number] representative.
502 Alarm Compacting database Not OK Database compacting failed Contact your local
HORIBA Medical
representative.
503 Alarm Bad Embedded Software Bad embedded software Contact your local
Version Required [version version HORIBA Medical
number], Current [version representative.
number]
504 Alarm Bad CPLD version Required Bad CPLD version Contact your local
[version number], Current HORIBA Medical
[version number] representative.
505 Alarm Light stability Not OK The lamp stability is not Check the lamp and replace it
reached during the if necessary.
initialization. Run an initialization.
506 Alarm Bad Embedded exchange Bad embedded exchange Contact your local
table: Version Required table version HORIBA Medical
[version number], Current representative.
[version number]
507 Alarm Bad PC exchange table: Bad computer exchange table Contact your local
Version Required [version version HORIBA Medical
number]
508 Alarm Bad Embedded exchange Bad embedded exchange Contact your local
table size: Version Required table size HORIBA Medical
[version number], Current representative.
[version number]
412 User Manual

Alarms

509 Alarm Bad PC exchange table size: Bad computer exchange table Contact your local
Version Required [version size HORIBA Medical
number]
510 Alarm Loading Module [module Loading failed for the module Run an initialization.
name]: Not OK in brackets (IHM,
COMPROCESS)
511 Alarm Unable to found empty No new cuvette on the Add cuvette segments.
cuvette on a reaction tray reaction tray Run an initialization.
513 Alarm Communication Problem Internal communication failed Run an initialization.
514 Alarm At least 2 identical Barcodes Two cassettes or racks having Check and remove one of
detected the same barcode have been them if necessary.
placed on the reagent tray. Run an initialization.
515 Alarm Problem when configuring the Sample barcode reader Shutdown the instrument.
Sample Barcode Reader configuration failed Switch the instrument off and
on.
516 Alarm Problem when configuring the Reagent barcode reader Shutdown the instrument.
Reagent Barcode Reader configuration failed Switch the instrument off and
on.
517 Alarm Light intensity out of range The light intensity is out of Check the lamp and replace it
range during the initialization. if necessary.
518 Alarm Motor [motor name], function Motor offset value out of Contact your local
position [position name], value range HORIBA Medical
[old value, new value] has representative.
changed
519 Alarm Bad ISE version Required Bad ISE module version Contact your local
[version number], Current HORIBA Medical
[version number] representative.
520 Alarm The lamp has failed the gain Spectrophotometer gains are Replace the lamp.
check. [wavelength nm / gain out of range. Run an initialization.
in % of Gain] Please change
the lamp.

600 Warning Loading Module [module Loading failed for the module Check the module
name]: Not OK in brackets (PRINTER, connections.
COMSIL) Run an initialization.
601 Warning Language database version Bad language database Contact your local
[version number] Not OK, version HORIBA Medical
version required [version representative.
number]
602 Warning Not Enough Clean Cuvettes Less than four new cuvettes Add cuvette segments.
on Reaction Tray to Start on the reaction tray
Analysis
603 Warning No Ordered Sample on No ordered sample tube on Place sample tubes on the
Sample Tray the sample tray sample tray.
604 Warning This Sample ID [sample ID] is The sample ID in brackets, Modify the sample ID from the
a reserved code programmed from the host, host.
contains the "AUTO_SID"
prefix.
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Alarms

605 Warning This Patient ID [patient ID] is a The patient ID in brackets, Modify the patient ID from the
reserved code programmed from the host, host.
contains the "AUTO_PID"
prefix.
606 Warning Main Cover Open Main cover open Close the main cover.
607 Warning Reagent Door Open Reagent tray cover open Close the reagent tray cover.
608 Warning Manual Cuvette Loading Door Reaction tray door open Close the reaction tray door.
Open
609 Warning Used Cuvette Holder missing "Used cuvette" holder absent Reinstall the holder.
610 Warning Water Tank Empty Water tank empty Check the distilled water level
necessary.
611 Warning Waste Tank Full Waste tank full Check the waste level in the
tank. Empty the tank if
necessary.
612 Warning Mixer missing Mixer absent Push the mixer down.
613 Warning System cleaning failed Needles cleaning failed Make sure that the cleaning
solution is placed on the
reagent tray.
614 Warning ISE cleaning failed ISE module cleaning failed Make sure that the cleaning
solution is placed on the
reagent tray.
616 Warning ISE Module busy The ISE module is busy Wait until the ISE module is
(performing an ISE calibration ready.
for example).
617 Warning Sample Rack Duplicate Two racks having the same Check and remove one of
Detected rack number are placed on them if necessary.
the sample tray.
618 Warning Database save not OK Database save failed Contact your local
HORIBA Medical
representative.
619 Warning Sample Rack Duplicate Two racks having the same Check and remove one of
Detected rack number are placed on them if necessary.
the sample tray.
620 Warning L.I.S. order can't be A request, programmed from Check and modify the request
performed for SID [sample ID]: the host, does not comply from the host.
incorrect value [value] in field with the ASTM format. The
[field] fields sample ID, action code
or sample type contain an
incorrect value.
621 Warning Write error on the electronic The serial number recording Contact your local
key on the electronic key has HORIBA Medical
failed. representative.
622 Warning Serial ## on the electronic key The instrument serial number Check the instrument serial
is incompatible with serie ## is different from the serial number in the System
on memory number recorded on the Configuration menu.
electronic key.
623 Warning Access to electronic key is The communication between Contact your local
impossible the instrument and the HORIBA Medical
electronic key has failed. representative.
624 Warning Duplicate barcode: Sample Two sample tubes having the Check and remove one of
[read barcode] was detected same barcode are placed on them if necessary.
in [rack position of sample the sample tray.
tube no.1] and in [rack
position of sample tube no.2]
414 User Manual

Alarms

625 Warning Completed Sample [rack The sample tube has been Place the sample tube back to
position of sample tube, moved (for a sample that is for its previous position.
sample ID] is now detected on validation or validated).
Rack.Pos: [rack position of
sample tube]
626 Warning Pressure Sample calibration The calibration of the sample Check the sample needle and
failed needle pressure detection has clean it if necessary.
failed. Check the sample syringe and
the fluidic system.
Recalibrate the sample needle
pressure detection.
627 Warning Pressure Reagent calibration The calibration of reagent Check the reagent needle and
failed needle pressure detection has clean it if necessary.
failed. Check the reagent syringe
and the fluidic system.
Recalibrate the reagent needle
pressure detection.
628 Warning Restore database saved on The database in brackets has -
[date and time] by [user name] been restored.
629 Warning The lamp is dying, it is still Spectrophotometer gains are You will have to replace the
operational but you will need reaching limits. lamp soon.
to change it soon. [wavelength
nm / gain in % of Gain].
630 Warning Rack label not read on sector The barcode label of the Check the barcode label.
[sample tray position] sample rack is not read.
631 Warning Rack label not read on sector The barcode label of the Check the barcode label.
[sample tray position] for SID: sample rack is not read.
[sample ID]
632 Warning SID [sample ID] on position The sample tube has been Place the sample tube back to
[rack position of sample tube] removed during the analysis. its previous position.
no longer displayed
633 Warning SID [sample ID] on position The barcode label of the Check the barcode label.
[rack position of sample tube] sample tube is not read.
not read
634 Warning Restore system configuration The system configuration has -
the [date and time] by [user been restored.
name]
635 Warning Restore column configuration The columns configuration -
the [date and time] by [user has been restored.
name]
636 Warning Rack [rack number] on sector The rack is not configured. Configure the rack in System
[sample tray position] not Configuration menu.
configured
637 Warning Not enough cleaner solution Not enough solution to Check the solution and
[solution name] perform the cleaning required replace it if necessary.
from Customer Services Activate the solution in the
menu or at the instrument Reagent Configuration
shutdown. menu.
Rerun the cleaning from
Customer Services menu or
rerun the shutdown.
638 Warning Unable to save results onto Results save on a USB key Check your USB key.
USB stick failed
639 Warning Saving archive database failed Archive file save failed Contact your local
HORIBA Medical
representative.
640 Warning Rack position modified [rack The sample rack has been Place the sample rack back to
number] moved during the analysis. its previous position.
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Alarms

641 Warning Rack position modified [rack The sample rack has been Place the sample rack back to
number] for SID: [sample ID] moved during the analysis. its previous position.
642 Warning Worklist performed with The analyses have been Rerun the analyses after
reagent tray temperature performed though the performing the appropriate
[temperature] out of the range temperature in the refrigerated controls.
(acceptable range) area of reagent tray was out of
range.
644 Warning LIS order cannot be The patient ID in brackets, Check and modify the request
performed. No order programmed from the host, from the host.
information available for PID has no related request.
[patient ID].
645 Warning LIS order cannot be Host communication/protocol Contact your Information
performed: communication/ error Technology Services
protocol error. Order company to check the host
information for SID [sample connection configuration.
ID] could not be processed.
protocol error. Patient company to check the host
information for PID [patient ID] connection configuration.
could not be processed.
protocol error. Information for company to check the host
PID [patient ID] and related connection configuration.
orders SID(s): [sample ID]
could not be processed.
648 Warning LIS communication/protocol Host communication/protocol Contact your Information
error. Comment information error Technology Services
could not be processed. company to check the host
connection configuration.
649 Warning LIS communication/protocol Host communication/protocol Contact your Information
error. Query information could error Technology Services
not be processed. company to check the host
connection configuration.
650 Warning L.I.S. order with SID [sample A request, programmed from Check and modify the request
ID] error. The following tests the host, has one or several from the host.
are rejected: [test no.1 (reason rejected tests. Each rejected
no.1), test no.2 (reason no.2), test contains one of the
etc]. following errors.
■ "Channel error": The test
field does not contain a
channel number.
■ "Disabled": The test is
disabled on the
instrument.
■ "Not configured": The test
is not configured on the
instrument.
■ "Sample type
incompatible": The
sample type of the test
does not match the
sample.
654 Warning Position change: Sample [read The sample tube has been Place the sample tube back to
barcode] was detected in moved during analysis (strictly its previous position.
[rack position of the sample forbidden).
tube], but it is expected to be
in [rack position of the sample
tube]
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Alarms

655 Warning Mismatch: Sample [read For a rack position, the Check the sample.
barcode] was detected in sample ID in the worklist is Modify the sample ID in the
[rack position of the sample different from the read worklist or move the sample
tube] instead of expected barcode. tube to its correct position.
sample [expected barcode]
1.3. Additional Information
1.3.1. Temperature Warnings and Alarms
The table below describes how the temperature warnings and alarms are triggered.
Code Level Message Acceptable range Time of

stabilization
The stability was not reached during the instrument initialization.
053 Alarm Reaction Tray Temperature regulation failed 37°C +/- 0.25°C < 15 minutes
054 Alarm Heating Needle Temperature regulation failed 37°C +/- 1.5°C < 10 minutes
055 Alarm Refrigerated Compartment Temperature 4-10°C < 4 hours*
regulation failed
The stability was reached during the instrument initialization but the temperature is now out of range.
123 Warning Reaction tray temperature exceeds limits 37°C +/- 0.25°C < 2 minutes
053 Alarm Reaction Tray Temperature regulation failed 37°C +/- 0.5°C None
124 Warning Heating needle temperature exceeds limits 37°C +/- 1.5°C < 24 seconds
054 Alarm Heating Needle Temperature regulation failed 37°C +/- 3°C None
305 Warning Reagent tray temperature exceeds limits 4-10°C < 30 minutes
055 Alarm Refrigerated Compartment Temperature 2-12°C None
regulation failed
* Every hour from the start of the cooling unit, the temperature in the refrigerated area of
the reagent tray (if it is still out of the acceptable range) is checked to ensure that it is
decreasing by at least two degrees per hour. If not, the alarm #055 Refrigerated
Compartment Temperature regulation failed is triggered.
1.3.2. Compressor Overload Alarm
This chapter describes how the Compressor Overload alarm is managed.

If the Compressor Overload alarm is triggered for the first time, the warning #340 Compressor
overload: Refrigeration is stopped temporarily for 10 minutes is triggered. This means that the cooling
unit has stopped for ten minutes and automatically restarted afterwards.
Once the cooling unit has automatically been restarted:
■ If a second Compressor Overload alarm is triggered within five minutes, the alarm #147
Compressor overload: Refrigeration has been stopped is triggered. This means that the cooling
unit has stopped.
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Alarms
ON
OFF
0 5 10 15 20 25 Time
First alarm -> Second alarm within 5 min. ->

warning #340 alarm #147
■ After five minutes, the cooling unit operation is back to normal. If a new Compressor Overload
alarm is triggered, it is considered as the first one.
ON
OFF
0 5 10 15 20 25 Time
First alarm -> New alarm after 5 min. ->

warning #340 warning #340
1.3.3. Reagent Level Detection Board Errors
The table below lists the errors that can appear on the reagent level detection board and can trigger
the alarm #157 Error card reagent detection [error code: message].
Code Message Description Action

001 Defective card (Autotest) The reagent level detection board Shutdown the instrument.
is defective. Switch the instrument off and on.
If the problem persists, disable the
reagent level detection and contact
the manufacturer local
representative.
002 Defective card (Category) The reagent level detection board Disable the reagent level detection
or the embedded software version and contact the manufacturer local
is defective. representative.
004 Calibration not performed No valid calibration Calibrate the reagent level
detection.
005 Reference error Reference measurement on air out Recalibrate the reagent level
of range detection.
Replace the reagent needle.
007 Calibration failed The calibration has failed. Recalibrate the reagent level
detection.
Replace the reagent needle.
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Alarms
Code Message Description Action

008 Card busy The reagent level detection board Disable the reagent level detection
is busy. and contact the manufacturer local
representative.
009 Absent or incompatible The reagent level detection board Disable the reagent level detection
card is absent or incompatible. and contact the manufacturer local
representative.
1.3.4. Instrument Initialization Special Message
During the instrument initialization, the following dialog box may be displayed: Transmission not
successful, do you want to continue to process queued messages?. This message means that data
sent to the host is pending.
■ Press OK to send the pending data to host as soon as the connection is running.
■ Press Cancel to delete the pending data.
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Alarms
Sampling Alarms
2. Sampling Alarms
The table below lists the sampling alarms that can appear during instrument operation.
When a sampling alarm is triggered, the Test Review button becomes red until you press it to open
Test Review menu.
When a sampling alarm is triggered, follow the instructions given in the table below.
Message Description Action

INTERRUPT A sampling alarm has interrupted the The tests not completed will be
tests in progress. performed at the next start.
SAMPLE_EMPTY Insufficient volume (detected by the Check the sample.
sample needle).
Tests in progress for this sample are
interrupted.
SOLUTION_EMPTY/SN Insufficient volume (detected by the Check the solution and replace it if
sample needle). necessary.
The solution is then deactivated. Activate the solution in the Reagent
Tests in progress for this solution are Configuration menu.
interrupted.
SOLUTION_EMPTY/RN Insufficient volume (detected by the Check the solution and replace it if
reagent needle). necessary.
The solution is then deactivated. Activate the solution in the Reagent
Tests in progress for this solution are Configuration menu.
interrupted.
SAMPLE_FOAM Air bubbles or insufficient volume Check the sample.
(detected by the sample pressure
sensor).
interrupted.
SOLUTION_FOAM/SN Air bubbles or insufficient volume Check the solution and replace it if
(detected by the sample pressure necessary.
sensor). Activate the solution in the Reagent
The solution is then deactivated. Configuration menu.
Tests in progress for this solution are
interrupted.
SOLUTION_FOAM/RN Air bubbles or insufficient volume Check the solution and replace it if
(detected by the reagent pressure necessary.
interrupted.
SAMPLE_FIBRIN The sample needle may be clogged Check the sample.
(detected by the sample pressure Make sure that the sample needle is
sensor). not clogged and clean it if
Tests in progress for this sample are necessary.
interrupted. Calibrate the sample needle
pressure detection.
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Alarms
Sampling Alarms

SOLUTION_CLOGGING/SN The sample needle may be clogged Check the sample needle and the
(detected by the sample pressure teflon tubing.
sensor). Calibrate the sample needle
The solution is then deactivated. pressure detection.
Tests in progress for this solution are Check the solution and replace it if
interrupted. necessary.
Activate the solution in the Reagent
Configuration menu.
SOLUTION_CLOGGING/RN The reagent needle may be clogged Check the reagent needle and the
(detected by the reagent pressure teflon tubing.
sensor). Calibrate the reagent needle
The solution is then deactivated. pressure detection.
Tests in progress for this solution are Check the solution and replace it if
interrupted. necessary.
Activate the solution in the Reagent
Configuration menu.
SAMPLE_SHOCK The sample may be capped. Check the sample.
interrupted.
SOLUTION_SHOCK The solution may be capped. Check the solution and remove the
The solution is then deactivated. caps if necessary.
Tests in progress for this solution are Activate the solution in the Reagent
interrupted. Configuration menu.
INC_SAMPLE_PIPET Air bubbles or insufficient volume Check the sample.
(detected by the sample pressure
sensor).
interrupted.
INC_SOLUTION_PIPET/SN Air bubbles or insufficient volume Check the solution and replace it if
(detected by the sample pressure necessary.
interrupted.
INC_SOLUTION_PIPET/RN Air bubbles or insufficient volume Check the solution and replace it if
(detected by the reagent pressure necessary.
interrupted.
REAG_MISSING The reagent is missing. Place the reagent on the reagent
tray.
DIL_MISSING The diluent is missing. Place the diluent on the reagent tray.
CLEANER_MISSING The cleaner is missing. Place the cleaner on the reagent
tray.
REAG_LOCKED The reagent is deactivated. Activate the solution in the Reagent
It then cannot be used for the Configuration menu.
pending analyses.
DIL_LOCKED The diluent is deactivated. Activate the solution in the Reagent
pending analyses.
CLEANER_LOCKED The cleaner is deactivated. Activate the solution in the Reagent
pending analyses.
REAG_EXPIRED The reagent has expired. Replace the reagent.
It then cannot be used for the
pending analyses.
DIL_EXPIRED The diluent has expired. Replace the diluent.
pending analyses.
User Manual 421

Alarms
Sampling Alarms

CLEANER_EXPIRED The cleaner has expired. Replace the cleaner.
pending analyses.
NOT_ENOUGH_REAG Not enough reagent for the pending Replace the reagent.
analyses.
Insuf. Diluent Not enough diluent for the pending Replace the diluent.
analyses.
Insuf. Cleaner Not enough cleaner for the pending Replace the cleaner.
analyses.
Calibrator Exp. The calibrator has expired. Replace the calibrator.
CTRL_EXPIRED The control has expired. Replace the control.
Pos. not set The calibrator or control position is Configure the calibrator or control
not configured. position in Calibration/Control
menu.
Calibrator Miss The calibrator is missing Place the calibrator.
CTRL_MISSING The control is missing Place the control.
No Cal. in Memory No current valid calibration for this Perform a new calibration for this
test. test.
No Ctrl in Memory No current valid control for this test. Perform a new control for this test.
NOT_ENOUGH_CUV Not enough new cuvettes in the Add cuvette segments.
cuvette changer.
Mismatch For a rack position, the sample ID in Check the sample.
the worklist is different from the read Modify the sample ID in the worklist
barcode. or move the sample tube to its
correct position.
POS_CHANGE The sample tube has been moved Place the sample tube back to its
during analysis (strictly forbidden). previous position.
Barcode Dup. Two sample tubes having the same Check and remove one of them if
barcode are placed on the sample necessary.
tray.
TUBE_LABEL_NOT_READ The barcode label of the sample Check the barcode label.
tube is not read.
TUBE_DISAPPEAR The sample tube has been removed Place the sample tube back to its
during the analysis. previous position.
TUBE_NOT_PRESENT The sample tube has been removed Place the sample tube back to its
whereas all tests of the sample are previous position.
not finished.
RACK_NOT_READ The barcode label of the sample rack Check the barcode label.
is not read.
POSCHANGE_RACK The sample rack has been moved Place the sample rack back to its
during the analysis. previous position.
ACTIVE_REAGENT_ABX_CASSETTE No active cassette for this reagent. Activate the solution in the Reagent
_MISSING Configuration menu.
ACTIVE_DILUANT_ABX_CASSETTE_ No active cassette for this diluent. Activate the solution in the Reagent
MISSING Configuration menu.
ACTIVE_CLEANER_ABX_CASSETTE No active cassette for this cleaner. Activate the solution in the Reagent
_MISSING Configuration menu.
Electrode disabled The electrode is deactivated. Activate the electrode in Customer
Services menu.
422 User Manual

Alarms
Analytical and Quality Flags
3. Analytical and Quality Flags
3.1. Analytical Flags
The absorbance analytical flags are divided into three subcategories:

■ kinetic analytical flags,
■ calibration analytical flags,
■ result analytical flags.
3.1.1. Kinetic Analytical Flags
This chapter describes the analytical flags that apply to kinetic curves for all cuvettes (Blank,
Calibrator, Control, Patient sample).
HIGH_ABS
Message HIGH_ABS
Definition At least one absorbance point used in the calculation has exceeded 3.0 A if the
wavelength is 340 nm, or 3.5 A for other wavelengths.
Applies on Blank, Calibration, Control, Patient sample
Implications The result is not displayed.
■ Blank and calibration: The calibration is then flagged with CALCHK_ERROR.
■ Control: The control cannot be validated.
■ Patient sample: The sample is automatically rerun with post-dilution if programmed in
the application.
Actions ■ Blank and calibration: Reassay with fresh reagent.
■ Control: Reassay with fresh control. Check pipetting process (needles, run T1 or P1).
■ Patient sample: If no post-dilution is programmed in the application, manually dilute
the sample and reassay.
normal run
OD run with flag
OD > 3.0
at 340 nm
0 36 72 108 144 180 216

time (s)
User Manual 423

Alarms
SAMPLE_LIMIT
Message SAMPLE_LIMIT
Definition The sample limit value is used to determine the sample-specific absorbance.
The reagent blank absorbance is subtracted from the sample absorbance, both measured
at the defined cycle. The calculated value is checked to ensure that it is not higher than the
programmed sample limit value.
Applies on Patient sample
Implications The result is displayed and flagged.
Actions Check the sample visually for any interferences; it may be icteric, hemolytic or lipemic.
Dilute it manually and reassay.
normal run
run with flag
OD blank
Sample
limit
0 12 24 36 48 60 72 84 96 108 120 132 144 156 168

time (s)
Sample limit cycle
424 User Manual

Alarms
REAG_RANGE_HIGH / LOW
Message REAG_RANGE_HIGH
REAG_RANGE_LOW
Definition All reagent blank absorbance values used for calculations are checked to ensure that they
are not out of the programmed reagent range.
Applies on Blank
The calibration is then flagged with CALCHK_FLAG.
Actions Reassay with fresh reagent. Check the water quality and verify the maintenance. Check
the quality of the cuvettes.
run with flag

blank
OD
Reagent
range OD
0 12 24 36 48 60 72 84 96 108 120 132 144 156 168

time (s)
User Manual 425

Alarms
BLK_RANGE
Message BLK_RANGE
Definition The absorbance variation of the reagent blank is checked to ensure that it is not out of the
programmed blank range.
Applies on Blank
Actions Reassay with fresh reagent. Check the water quality and verify the maintenance. Check
the quality of the cuvettes.
OD blank range high

blank
ΔOD
Blank range
0 12 24 36 48 60 72 84 96 108 120 132 144 156 168

time (s)
426 User Manual

Alarms
NON_LIN
Message NON_LIN_A, NON_LIN_B, NON_LIN_C, NON_LIN_D
Definition The Kinsearch calculation type failed to find a linear portion of the reaction curve or less
than 5 data points are within the linear portion. This flag applies to each calculation step
(Steps A, B, C and D).
■ Blank and calibration: The calibration is then flagged with CALCHK_ERROR.
the application.
Actions ■ Blank and calibration: Reassay with fresh reagent.
■ Control: Reassay with fresh control and/or reagent.
Reassay with fresh reagent if more than one sample gets the alarm.
normal run
run with flag
OD
Reading zone
0 24 48 72 96 120 144 168

time (s)
User Manual 427

Alarms
NOISE
Message NOISE_A, NOISE_B, NOISE_C, NOISE_D
Definition Only for the Kinsearch calculation type. One or more data points within the linear portion of
the reaction curve exceed a calculated difference from the regression line. This flag applies
to each calculation step (Steps A, B, C and D).
Implications The result is displayed.
■ Blank and calibration: Does not flag nor block the calibration calculation.
■ Control: The control cannot be automatically validated. If a default control is manually
validated, all following results are flagged with Q (CTRL_ERROR).
■ Patient sample: The result is flagged.
Actions ■ Blank and calibration: Rerun if necessary.
■ Control: Reassay with fresh control and/or reagent.
■ Patient sample: Reassay with fresh reagent if more than one sample gets the alarm.
normal run
OD run with flag
Reading zone
0 60 120 180 240 300 360

time (s)
HIGH_ACTIV
Message HIGH_ACTIV
Definition This flag appears if the reaction limit check and the reaction direction check fail
simultaneously.
Applies on Control, Patient sample
the application.
Actions ■ Control: Reassay with fresh control. Check pipetting process (needles, run T1 or P1).
428 User Manual

Alarms
REAC_LIMIT
Message REAC_LIMIT_A, REAC_LIMIT_B, REAC_LIMIT_C, REAC_LIMIT_D
Definition Only for Kinetic and Kinsearch calculation types.
The reaction limit value is used to determine substrate depletion.
■ For the Kinetic calculation type: the absorbance measured at the defined cycle is
subtracted from the absorbance value of the first reading point.
■ For the Kinsearch calculation type: the absorbance measured at the defined cycle is
subtracted from the absorbance value of the first point within the linear range.
The calculated value is checked to ensure that it is not higher than the programmed
reaction limit value. This flag applies to each calculation step (Steps A, B, C and D).
the application.
OD normal run
run with flag
Reaction
limit Abs
0 60 120 180 Cycles 240 300 360

time (s)
User Manual 429

Alarms
SIGN
Message SIGN
Definition The absorbance change for the flagged sample minus the absorbance change of the
reagent blank does not agree with the reaction direction programmed in the application.
Applies on Calibration, Control, Patient sample
■ Calibration: The calibration is then flagged with CALCHK_ERROR.
■ Patient sample: The sample is flagged.
Actions ■ Calibration: Check no air bubbles. Check pipetting process (needles, run T1 or P1).
■ Control: Check no air bubbles. Check pipetting process (needles, run T1 or P1).
■ Patient sample: Check no air bubbles, no fibrin clot. Check sample type (serum,
plasma, EDTA).
Reassay with fresh reagent if more than one sample gets the alarm.
normal run
run with flag
OD
+
0 12 24 36 48 60 72 84 96 108 120 132 144 156 168 180

time (s)
DIV_ABS
Message DIV_ABS_A, DIV_ABS_B, DIV_ABS_C, DIV_ABS_D
Definition Only for Kinetic and Kinsearch calculation types.
The correlation coefficient r2 and the standard deviation SD are calculated.
■ For the Kinetic calculation type, the measurement points used to calculate r2 and SD
are those included between the first reading cycle and the last reading cycle.
■ For the Kinsearch calculation type, the measurement points used to calculate r2 and
SD are those included in the linear range found by the linear search program.
If r2 is lower than the configured r2 threshold and SD is higher than the configured SD
threshold, then the analytical flag DIV_ABS is triggered. This flag applies to each
calculation step (Steps A, B, C and D).
430 User Manual

Alarms
DIV_ABS
■ Calibration: The calibration is then flagged with CALCHK_FLAG.
Actions Check the absorbances. Make sure that there are no air bubbles. Reassay.
normal run
run with flag
OD
r2 = 0.99
r2 = 0.70
0 60 120 180 240 300 360

time (s)
DIV_ABSi
Message DIV_ABSi_A, DIV_ABSi_B, DIV_ABSi_C, DIV_ABSi_D
Definition Only for the Endpoint calculation type.
Two different algorithms can be used for this check: one if the first reading cycle < 4,
another if the first reading cycle ≥ 4.
■ If the first reading cycle < 4, a calculated absorbance difference is checked to ensure
that it is included in the configured blank range.
■ If the first reading cycle ≥ 4, three calculated absorbance differences are checked to
ensure that they are lower than the configured threshold. If at least two absorbance
differences are greater than or equal to the configured threshold, the analytical flag
DIV_ABSi is triggered.
This flag applies to each calculation step (Steps A, B, C and D).
User Manual 431

Alarms
Reagent blank
OD Normal run
Run with flag
Diff > blank range
A0
An
Blank range
0 12 24 36 48 60 72
Time (s)
First reading cycle < 4
Normal run
Run with flag
OD
A0
D1
0 60 120 180 240 300

Time (s)
First reading cycle ≥ 4
DIV_ABSf
Message DIV_ABSf_A, DIV_ABSf_B, DIV_ABSf_C, DIV_ABSf_D
Definition Only for the Endpoint calculation type.
The difference between absorbance values at time n and at time n-1
(where n = last reading cycle) is calculated and checked to ensure that it is included in a
calculated range. This flag applies to each calculation step (Steps A, B, C and D).
432 User Manual

Alarms
DIV_ABSf
normal run
run with flag
OD
n
D1
0 60 120 180 240 300

time (s)
■ Calibration Analytical Flags, p.433
■ Quality Flags, p.444
■ Absorbance Deviation Checks, p.473
3.1.2. Calibration Analytical Flags
This chapter describes the analytical flags that apply when calculating calibration curves.
CALCHK_FLAG
Message CALCHK_FLAG
Definition At least one calibrator level is flagged with REAG_RANGE_HIGH / LOW, BLK_RANGE,
DEVIATION, DIV_ABS, DIV_ABSi or DIV_ABSf.
Applies on Calibration
User Manual 433

Alarms
CALCHK_FLAG
Implications The calibration is calculated and flagged. The calibration cannot be automatically
validated. If manually validated, all following results are flagged with C (CAL_ERROR).
Actions Check the absorbances. Make sure that there are no air bubbles and that the calibrator is
properly mixed. Check the pipetting precision (run T1 or P1). Reassay with fresh calibrator
and/or reagent. Check the water quality and verify the maintenance. Check the quality of
cuvettes.
CALCHK_ERROR
Message CALCHK_ERROR
Definition At least one calibrator level is flagged with HIGH_ABS, NON_LIN or SIGN.
Implications The calibration cannot be calculated and must be deleted. Then, the previous calibration
will become the current calibration and all following results are flagged with C
(CAL_ERROR).
Actions Make sure that there are no air bubbles. Check pipetting process (needles, run T1 or P1).
Reassay with fresh reagent.
CALC_ERROR
Message CALC_ERROR
Definition Three cases trigger this analytical flag:
■ For linear calibration modes (Slope average, Linear regression), the calculated
calibration factor is negative.
■ For non-linear calibration modes, the calculation algorithm cannot generate an
acceptable standard non-linear curve fit.
■ For mathematical algorithms (LOGIT/LOG4, LOGIT/LOG5, EXPONENT5), the curve fit
is not monotonic.
Implications The calibration cannot be calculated and must be deleted. Then, the previous calibration
will become the current calibration and all following results are flagged with C
(CAL_ERROR).
Actions Check the calibrator position. Reassay with fresh calibrator and/or reagent.
CAL_NOT_OPTIMISED
Message CAL_NOT_OPTIMISED
Definition For non-linear calibration modes, a maximum of 150 iterations is performed to optimize the
curve fit. If the number of 150 iterations is reached, the calibration is flagged. This means
that the calibration has been calculated but not with the best optimization.
Implications The calibration is calculated and flagged. The calibration can be validated manually or
automatically. If validated, all following results are flagged with C (CAL_ERROR).
Actions Reassay with fresh calibrator and/or reagent.
FACTOR_FLAG
Message FACTOR_FLAG
Definition For linear calibration modes (Slope average, Linear regression), the calculated calibration
factor failed one of the three calibration factor checks.
434 User Manual

Alarms
FACTOR_FLAG
Implications The calibration is calculated and flagged. The calibration cannot be automatically
validated. If manually validated, all following results are flagged with C (CAL_ERROR).
Actions Ensure that the entered target values correspond to the calibrator name and lot number
used. Reassay with fresh calibrator and/or reagent.
ΔOD
Calibration curve
Factor low
Factor high
Calibrator Concentrations
concentration
■ Kinetic Analytical Flags, p.423
■ Result Analytical Flags, p.435
3.1.3. Result Analytical Flags
This chapter describes the analytical flags that apply to results.
DEVIATION
Message DEVIATION
Definition Two types of deviation are checked.
■ Deviation concerning replicates (Dev_Rep): For each calibrator level, the
absorbance values of replicates are compared to the mean value. The maximum
deviation is calculated (Dev_Rep) and then checked to ensure that it is not higher than
the authorized Dev_Rep.
■ Deviation to the curve (Dev_C): For each calibrator level, the concentration of the
mean value is compared to the theoretical value. The deviation is calculated (Dev_C)
and then checked to ensure that it is not higher than the authorized Dev_C.
Actions Make sure that there are no air bubbles and that the calibrator is properly mixed. Check
pipetting precision (run T1 or P1). Reassay with fresh calibrator and/or reagent.
User Manual 435

Alarms
ΔOD
- Replicate 1'
- Replicate 1 too big difference

OK between replicates
- Mean
- Replicate 2
- Replicate 2'
Calibrator Concentrations
concentration
Deviation concerning replicates
ΔOD
calibration
curve
Calculated
concentration
0 50 100 150 200 250

Theorical Concentrations
concentration
Too big
difference
Deviation to the curve
RESULT_CALC_ERR
Message RESULT_CALC_ERR
Definition For the Linear regression calibration mode and the non-linear calibration modes, at least
one result could not be calculated using the selected algorithm.
436 User Manual

Alarms
RESULT_CALC_ERR
■ Patient sample: The sample is flagged.
■ Patient sample: Reassay with fresh reagent if more than one sample gets the alarm.
LINEARITY_HIGH / LOW
Message LINEARITY_HIGH
LINEARITY_LOW
Definition The sample result is checked to ensure that it is within the programmed linearity range.
■ Patient sample: The sample is automatically rerun with post-dilution or post-
concentration if programmed in the application.
■ Patient sample: In case of LINEARITY_HIGH flag and if no post-dilution is programmed
in the application, dilute the sample manually and reassay.
ΔOD
Linearity Low => post-conc Linearity High => post-dilution
Linearity Low Linearity High Concentrations
Linearity for linear calibration modes
User Manual 437

Alarms
ΔOD
Linearity
High
calibration
curve
Linearity
Low
0 50 100 150 200 250 Concentrations

Low cal High cal
value value
Linearity for non-linear calibration modes
CALC_RANGE_HIGH / LOW
Message CALC_RANGE_HIGH
CALC_RANGE_LOW
Definition Only for non-linear calibration modes.
■ Calibration: If, for the highest calibrator level, one absorbance value is higher than the
theoretical value, the analytical flag CALC_RANGE_HIGH is triggered. If, for the lowest
calibrator level, one absorbance value is lower than the theoretical value, the analytical
flag CALC_RANGE_LOW is triggered.
■ Control and Patient sample: If the absorbance value is between the calculated mean
value and the theoretical value of the highest calibrator level, the analytical flag
CALC_RANGE_HIGH is triggered. If the absorbance value is between the calculated
mean value and the theoretical value of the lowest calibrator level, the analytical flag
CALC_RANGE_LOW is triggered.
438 User Manual

Alarms
CALC_RANGE_HIGH / LOW
Implications In case of CALC_RANGE_HIGH flag, the result equals the highest calibrator level
concentration. In case of CALC_RANGE_LOW flag, the result equals the lowest calibrator
level concentration.
■ Calibration: Does not flag nor block the calibration calculation.
■ Patient sample: In case of CALC_RANGE_HIGH flag and if no post-dilution is
programmed in the application, dilute the sample manually and reassay.
ΔOD
Cal range
high
calibration
curve
Cal range low

Low cal High cal
value value
User Manual 439

Alarms
TEST_RANGE_HIGH / LOW
Message TEST_RANGE_HIGH
TEST_RANGE_LOW
Definition Only for non-linear calibration modes.
If the absorbance value is higher than the calculated mean value of the highest calibrator
level, the analytical flag TEST_RANGE_HIGH is triggered. If the absorbance value is lower
than the calculated mean value of the lowest calibrator level, the analytical flag
TEST_RANGE_LOW is triggered.
Actions ■ Control: Reassay with fresh control and/or reagent.
■ Patient sample: In case of TEST_RANGE_HIGH flag and if no post-dilution is
programmed in the application, dilute the sample manually and reassay.
ΔOD
Test range
high
calibration
curve
Test range low

Low cal High cal
value value
440 User Manual

Alarms
AG_EXCESS
Message AG_EXCESS
Definition The antigen excess check is used to detect the presence of excess antigen. The
concentration measured at the defined cycle (CCP) is divided by the concentration
measured at the last reading cycle (C) and multiplied by 100. The calculated ratio is
checked to ensure that it is higher than the programmed antigen excess limit value.
The sample is automatically rerun with post-dilution if programmed in the application.
Actions If no post-dilution is programmed in the application, dilute the sample manually and
reassay.
Ccp C
OD
Last reading
First reading
AGE
0 50 100 150 200 250 300

time (s)
CONF_RANGE_HIGH / LOW
Message CONF_RANGE_HIGH
CONF_RANGE_LOW
Definition The control result is outside the programmed confidence range. For a default control,
Westgard rules are disabled.
Applies on Control
User Manual 441

Alarms
CONF_RANGE_HIGH / LOW
The control cannot be automatically validated. If a default control is manually validated, all
following results are flagged with Q (CTRL_ERROR).
Actions Ensure that the entered target values correspond to the control name and lot number
used. Reassay with fresh control. Rerun calibration.
Concentration
CONF range High
High value
TARGET
Low value
CONF range Low
Date
CONF_RANGE_HIGH_W / LOW_W
Message CONF_RANGE_HIGH_W
CONF_RANGE_LOW_W
Definition The default control result is outside the programmed confidence range and no Westgard
rule is true.
Applies on Control
CONF_RANGE_HIGH_W1-6 / LOW_W1-6
Message CONF_RANGE_HIGH_W1-6
CONF_RANGE_LOW_W1-6
Definition The default control result is outside the programmed confidence range and the Westgard
rule 1, 2, 3, 4, 5 or 6 is true.
Applies on Control
WESTGARD_RULE_4-6
Message WESTGARD_RULE_4
WESTGARD_RULE_5
WESTGARD_RULE_6
Definition The default control result is inside the programmed confidence range and the Westgard
rule 4, 5 or 6 is true.
Applies on Control
442 User Manual

Alarms
WESTGARD_RULE_4-6
Actions Reassay with fresh control. Check pipetting precision (run T1 or P1).
For detailed information concerning Westgard rules, refer to the Quality Assurance >
Westgard Rules chapter.
REF_RANGE_HIGH / LOW
Message REF_RANGE_HIGH
REF_RANGE_LOW
Definition The result is outside the programmed reference range.
Actions Check the patient history.
ΔOD
REF_RANGE_LOW REF_RANGE_HIGH
Normal range
Low High Concentrations
CRITICAL_RANGE_HIGH / LOW
Message CRITICAL_RANGE_HIGH
CRITICAL_RANGE_LOW
Definition The result is outside the programmed critical range.
The sample is automatically rerun without post-dilution or post-concentration (a new test is
requested).
Actions Check the critical range programmed in the application. Check the patient history.
User Manual 443

Alarms
3.1.4. Analytical Flags Priority
When several analytical flags are triggered for the same result, only the flag having the highest priority
is displayed.
Analytical flags priority (from highest to lowest):
■ HIGH_ABS
■ SAMPLE_LIMIT
■ REAG_RANGE_HIGH / LOW
■ NON_LIN
■ HIGH_ACTIV
■ REAC_LIMIT
■ NOISE
■ AG_EXCESS
■ BLK_RANGE
■ SIGN
■ DIV_ABS, DIV_ABSi, DIV_ABSf
■ TEST_RANGE_HIGH / LOW
■ RESULT_CALC_ERR
■ DEVIATION
■ LINEARITY_HIGH / LOW
■ CONF_RANGE_HIGH / LOW, CONF_RANGE_HIGH_W / LOW_W, CONF_RANGE_HIGH_W1-6 /
LOW_W1-6, WESTGARD_RULE_4-6
■ CRITICAL_RANGE_HIGH / LOW
■ REF_RANGE_HIGH / LOW
■ CALC_RANGE_HIGH / LOW
3.2. Quality Flags
Message Quality flag Definition and Implications

R CAL_CONV Patient and control results converted using the CONV function
are flagged with R (CAL_CONV).
C CAL_ERROR Two cases trigger this quality flag:
■ If the calibration is flagged with CALCHK_FLAG,
CAL_NOT_OPTIMISED or FACTOR_FLAG and if validated,
all following results are flagged with C (CAL_ERROR).
■ In case the calibration is deleted, the previous calibration
will be the current calibration and all following results are
flagged with C (CAL_ERROR).
Q CTRL_ERROR If a default control is flagged (except with the analytical flag
CONF_RANGE_HIGH_W / LOW_W) and if validated, all
KE CAL_EXPIRED If the current calibration used has expired, the calibration is
flagged with KE (CAL_EXPIRED) and all following results are
CE CALIBRATOR_EXPIRED If the calibrator used has expired, the calibration is flagged
with CE (CALIBRATOR_EXPIRED) and all following results are
QE CTRL_EXPIRED If the control used has expired, the control is flagged with QE
(CTRL_EXPIRED).
If a default control is flagged with QE (CTRL_EXPIRED), all
444 User Manual

Alarms
Message Quality flag Definition and Implications

SE SOL_EXPIRED If the solution used has expired, the result is flagged with SE
(SOL_EXPIRED).
If the calibration is flagged with SE (SOL_EXPIRED), all
following results are flagged with C (CAL_ERROR).
If a default control is flagged with SE (SOL_EXPIRED), all
I INCOMPATIBILITY If two incompatible test samplings are performed one after the
other without the programmed cleaning, the second test result
is flagged with I (INCOMPATIBILITY).
If the calibration is flagged with I (INCOMPATIBILITY), all
following results are flagged with C (CAL_ERROR).
If a default control is flagged with I (INCOMPATIBILITY), all
Expired current calibrations, calibrators, controls and solutions can be used on your
instrument only if configured by HORIBA Medical or your local representative.
When several quality flags are triggered for the same result, only the flag having the highest priority is
displayed.
Quality flags priority (from highest to lowest):
■ R (CAL_CONV)
■ C (CAL_ERROR)
■ Q (CTRL_ERROR)
■ KE (CAL_EXPIRED)
■ CE (CALIBRATOR_EXPIRED)
■ QE (CTRL_EXPIRED)
■ SE (SOL_EXPIRED)
■ I (INCOMPATIBILITY)
■ Kinetic Analytical Flags, p.423
■ Result Analytical Flags, p.435
3.3. ISE Analytical Flags (Option)
The ISE analytical flags are divided into two subcategories:

■ calibration analytical flags,
■ result analytical flags.
Calibration analytical flags
Sensibility error
Message Sensibility error
Definition The difference between the low and high standard values is out of the sensitivity normal
range.
This flag is triggered by the ISE error code 050.
User Manual 445

Alarms
Sensibility error
Implications The ISE Module Status button is blue with a red circle. This means that the ISE module is
not calibrated.
Actions Run a 2-point calibration. Perform the ISE module maintenance. Change the concerned
electrode.
Offset error
Message Offset error
Definition The low or high standard value is out of the acceptable range.
not calibrated.
Actions Run a 2-point calibration. Perform the ISE module maintenance. Change the concerned
electrode.
Repeatability error
Message Repeatability error
Definition Repeatability error on the low standard value.
not calibrated.
Actions Make sure that there are no air bubbles in the Standard 1 bottle. Change the Standard 1
bottle. Perform the ISE module maintenance. Change the concerned electrode. Check the
spring contact of the concerned electrode.
Response error
Message Response error
Definition The potential difference during the three last seconds of a measurement is ≥ 0.40 mV.
not calibrated.
Actions Make sure that there are no air bubbles in the Standard 1 or Standard 2 bottle. Change the
Standard 1 or Standard 2 bottle. Perform the ISE module maintenance. Change the
concerned electrode. Check the spring contact of the concerned electrode.
Result analytical flags
ISE_ERROR
Message ISE_ERROR
Definition Two cases trigger this flag:
■ Repeatability error on the low standard value. The flag is triggered by the ISE error
code 052.
■ The potential difference during the three last seconds of a measurement is ≥ 0.40 mV.
The flag is triggered by the ISE error code 055.
Actions Reassay with fresh control or patient sample.
Check no air bubbles in the Standard 1 or Standard 2 bottle. Change the Standard 1 or
Standard 2 bottle. Perform the ISE module maintenance. Change the concerned electrode.
Check the spring contact of the concerned electrode.
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Alarms
For detailed information concerning ISE error codes, refer to the Alarms > ISE Error Codes
chapter.
■ ISE Error Codes, p.448
User Manual 447

Alarms
ISE Error Codes
4. ISE Error Codes
The table below lists the errors that can appear on the ISE module.
When an ISE error code is triggered, follow the instructions given in the table below.
Code Warning Description Action

001 #318 Timeout error on ISE syringe ISE module mechanical error. Perform a global initialization of
1 (error code 1) ISE syringe 1 assy (Standard 1/ the ISE module.
waste) home position is not
reached on time.
002 #319 Position error on ISE syringe ISE module mechanical error. Perform a global initialization of
1 (error code 2) ISE syringe 1 assy (Standard 1/ the ISE module.
waste) home position is not
reached.
011 #320 Timeout error on ISE syringe ISE module mechanical error. Perform a global initialization of
2 (error code 11) ISE syringe 2 assy (Reference/ the ISE module.
Standard 2) home position is not
reached on time.
012 #321 Position error on ISE syringe ISE module mechanical error. Perform a global initialization of
2 (error code 12) ISE syringe 2 assy (Reference/ the ISE module.
Standard 2) home position is not
reached.
021 #322 Can't detect ISE low ISE module reagent/fluidic error. Check the Standard 1 bottle and
solution (error code 21) Air sensor cannot detect the fluidic system.
Standard 1. Perform a global initialization of
the ISE module.
022 #323 Can't detect ISE low ISE module reagent/fluidic error. Check the Standard 1 bottle and
solution inlet (error code 22) Air sensor cannot detect the the fluidic system.
arriving of Standard 1. Perform a global initialization of
the ISE module.
023 #324 Too much ISE low solution ISE module reagent/fluidic error. Check the Standard 1 bottle and
inlet (error code 23) Air sensor detects Standard 1. the fluidic system.
Perform a global initialization of
the ISE module.
024 #325 ISE low solution inlet excess ISE module reagent/fluidic error. Check the Standard 1 bottle and
on timeout (error code 24) Air sensor still detects Standard 1 the fluidic system.
flow after the specified time of Perform a global initialization of
aspiration. the ISE module.
025 #326 ISE low solution inlet excess ISE module reagent/fluidic error. Check the Standard 1 bottle and
on start of measuring (error code Air sensor detects Standard 1 at the fluidic system.
25) the beginning of measurement. Perform a global initialization of
the ISE module.
031 #327 Can't detect ISE high ISE module reagent/fluidic error. Check the Standard 2 bottle and
solution (error code 31) Air sensor cannot detect the fluidic system.
Standard 2. Perform a global initialization of
the ISE module.
032 #328 Can't detect ISE high ISE module reagent/fluidic error. Check the Standard 2 bottle and
solution inlet (error code 32) Air sensor cannot detect the the fluidic system.
arriving of Standard 2. Perform a global initialization of
the ISE module.
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Alarms
ISE Error Codes
Code Warning Description Action

033 #329 Too much ISE high solution ISE module reagent/fluidic error. Check the Standard 2 bottle and
inlet (error code 33) Air sensor detects Standard 2. the fluidic system.
Perform a global initialization of
the ISE module.
034 #330 ISE high solution inlet ISE module reagent/fluidic error. Check the Standard 2 bottle and
excess on timeout (error code 34) Air sensor still detects Standard 2 the fluidic system.
flow after the specified time of Perform a global initialization of
aspiration. the ISE module.
041 #331 Can't detect ISE sample ISE module reagent/fluidic error. Make sure that there is no fibrin
(error code 41) Air sensor cannot detect sample. clot in the sample.
Check the sample needle and the
teflon tubing.
042 #332 Can't detect ISE sample ISE module reagent/fluidic error. Make sure that there is no fibrin
inlet (error code 42) Air sensor cannot detect the clot in the sample.
arriving of sample. Check the sample needle and the
teflon tubing.
043 #333 Too much ISE sample inlet ISE module reagent/fluidic error. Check the fluidic system.
(error code 43) Air sensor detects sample. Perform a global initialization of
the ISE module.
044 #334 ISE sample inlet excess on ISE module reagent/fluidic error. Check the fluidic system.
timeout (error code 44) Air sensor still detects sample Perform a global initialization of
flow after the specified time of the ISE module.
aspiration.
050 #335 ISE electrode [electrode The difference between the low Run a 2-point calibration. Perform
name] sensibility error for [low or and high standard values is out of the ISE module maintenance.
high standard value] point (error the sensitivity normal range for Change the concerned electrode.
code 50) the electrode in brackets.
051 #336 ISE electrode [electrode The low or high standard value is Run a 2-point calibration. Perform
name] offset error for [low or high out of the acceptable range for the ISE module maintenance.
standard value] point (error code the electrode in brackets. Change the concerned electrode.
51)
052 #337 ISE electrode [electrode Repeatability error on the low Make sure that there are no air
name] repeatability error for [low standard value for the electrode in bubbles in the Standard 1 bottle.
or high standard value] point brackets. Change the Standard 1 bottle.
(error code 52) Perform the ISE module
maintenance. Change the
concerned electrode. Check the
spring contact of the concerned
electrode.
055 #338 ISE electrode [electrode The potential difference during Make sure that there are no air
name] response error for [low or the three last seconds of a bubbles in the Standard 1 or
high standard value] point (error measurement is ≥ 0.40 mV for the Standard 2 bottle. Change the
code 55) electrode in brackets. Standard 1 or Standard 2 bottle.
Perform the ISE module
maintenance. Change the
concerned electrode. Check the
spring contact of the concerned
electrode.
091 #339 ISE LB check response error ISE module mechanical error. Perform a global initialization of
(error code 91) the ISE module.
101 #060 Non recoverable material ISE module error Shutdown the instrument.
error on the ISE module Switch the instrument off and on.
User Manual 449

Alarms
ISE Error Codes
450 User Manual

Description and Technology
1. Instrument Description.....................................................................................................452
1.1. Reagent and Sample Trays........................................................................................................452
1.2. Sampling System....................................................................................................................... 458
1.3. Analytical Module.......................................................................................................................461
1.4. ISE Module (Option)................................................................................................................... 463
1.5. Analysis Cycle Diagram............................................................................................................. 465
2. Data Analysis........................................................................................................................ 466

2.1. Absorbance Measurements....................................................................................................... 466
2.2. Electrolyte Measurements..........................................................................................................483
User Manual 451

Instrument Description
1. Instrument Description
The Pentra C400 includes several parts:

■ Reagent tray
■ Sample tray
■ Sampling system
■ Cuvette changer
■ Reaction tray
■ Mixer
■ Spectrophotometer
■ ISE module (option)
1.1.1. Reagent Tray
positions at room temperature. The temperature in the refrigerated area of reagent tray is maintained
at 4°C - 10°C (39°F - 50°F) 24 hours a day by a cooling unit with glycol circulation.
The reagent tray can hold reagent cassettes, reagent racks and calibrator/control reagent racks.
■ The cassettes and the open cassettes occupy one position per cassette on the tray. The cassettes
are either single compartment or twin compartment containers. One cassette is dedicated to a
single solution: either a reagent, a diluent or a cleaner.
■ The reagent racks occupy four positions per rack on the tray. The reagent racks are cut into three
sectors (each of three positions) and can accomodate either three reagents, diluents or cleaners or
a combination of the above (for example: one reagent and two diluents) in reagent vials of 4 mL,
10 mL and 15 mL.
■ The calibrator reagent racks occupy one position per rack on the tray. These racks can
accomodate up to three different calibrators in sample cups (with adaptors).
■ The control reagent racks occupy one position per rack on the tray. These racks can accomodate
up to three different controls in sample cups (with adaptors).
Reagents are loaded/unloaded on the reagent tray by the reagent tray cover.
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The colored circle around the reagent tray on the main menu indicates if the reagent tray
is accessible (green) or in progress (blue).
■ Pinch point! Be careful not to trap your hands/fingers.

Be careful when loading/unloading reagents on the reagent tray.
■ Warning! Reagents, diluents and cleaners should be handled cautiously according to
their corresponding notice.
A barcode reader allows reagent identification.
■ The cassettes are identified by a single barcode which allows the solutions automatic
configuration in Reagent Configuration menu. However, solutions in an open cassette must be
■ The reagent racks are identified by a specific barcode which indicates the rack ID. The solutions
on the reagent racks are manually configured in Reagent Configuration menu.
■ The calibrator/control reagent racks are identified by a specific barcode which indicates the rack
ID and if the rack is dedicated to calibrators or controls.
1.1.2. Sample Tray
The sample tray contains six positions, each position can hold a ten-sample rack for a total capacity
of 60 samples.
The sample tray can hold sample racks, sample cup racks and calibrator/control sample racks.
■ The sample racks have ten positions including five external positions and five internal positions.
The external positions can accomodate sample tubes of 7 and 10 mL (diameter: 16 mm) and the
User Manual 453

internal positions sample tubes of 4 and 5 mL (diameter: 13 mm). Samples tubes of 4 and 5 mL
(diameter: 13 mm) can also be positioned on the external positions with adaptors.
■ The sample cup racks have ten positions and can accomodate only sample cups.
■ The calibrator/control sample racks have ten positions and can accomodate only sample cups.
■ Do not wash or re-use sample tubes or sample cups. They are designed for single use
only.
■ When filling sample tubes or sample cups, dispense the sample slowly in order to
avoid the formation of foam.
■ Sample tubes or sample cups must always be uncapped before being positioned on
the sample tray or on the reagent tray.
Dispose of used sample tubes or sample cups according to your local/national guidelines
for biohazard waste disposal.
The sample tray access allows continuous loading of patient samples, calibrators and controls.
■ Before loading racks on the sample tray, ensure that the sample tray LED is green. If
not, press Pause to stop samplings on the sample tray and wait for the LED to turn
green.
■ If automatic reruns must be performed, the instrument turns to "Sampling" status and
the LED turns to orange for a few seconds before turning red. Never load racks on the
sample tray when the LED is orange or red.
The sample tray is equipped with a tube/cup detector and with a barcode reader which allows sample
identification.
Warning! Class 2 laser barcode reader

Do not stare directly into the beam or with optical instrument, as it may cause permanent
eye damage. Switch the instrument off before opening the barcode reader cover.
The sample barcode reader reads barcodes from two to 16 digits of the following types:
■ ITF 2/5 (2 of 5 interleaved) with or without check digit
■ Code 39 with or without check digit
■ Code 128
■ Codabar
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The sample barcode reader frequency (550 Hz) allows the reading of high resolution
barcodes (higher than or equal to 0.16 mm). However, this frequency does not allow the
reading of higher resolution barcodes (lower than 0.16 mm).
In order to ensure security of patient identification and sample identification, the space
character is allowed in the patient ID and the sample ID only when this one is placed
inside the capture. The space character is not authorized and is systematically deleted
when this one is the first character or the last character of the capture.
This rule also applies to the host connection and the sample barcode types Code 39 and
Code 128.
Also refer to the Settings > System Configuration > Host Connection > To Configure the
Host Connection chapter.
■ The sample racks are identified by a specific barcode which indicates the rack number. For
samples identified by a barcode, the barcode allows to automatically associate a sample tube on
the tray with a request in the worklist.
■ The sample cup racks are identified by a specific barcode which indicates the rack number.
■ The calibrator/control sample racks are identified by a specific barcode which indicates the rack
number and whether the rack is dedicated for calibrators or controls.
1.1.3. Cassette and Rack Labels
Reagent cassette labels

Reagent cassettes are identified by a single barcode which allows the solutions automatic
configuration in the Reagent Configuration menu. However, solutions in an open cassette must be
User Manual 455

1 = Barcode label
location
2 = 11.5 mm
Reagent rack labels

Three rack types are used on the reagent tray, they are differentiated by a color code on the rack
label:
■ White: reagent rack
■ Yellow: calibrator reagent rack
■ Green: control reagent rack
3 = Reagent rack
4 = Calibrator reagent rack
5 = Control reagent rack
Sample rack labels

Four rack types are used on the sample tray, they are differentiated by a color code on the rack label:
■ White: sample rack and sample cup rack
■ Yellow: calibrator sample rack
■ Green: control sample rack
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6 = Sample rack
7 = Sample cup rack
8 = Calibrator sample rack
9 = Control sample rack
HAX0281 (1207230281).
Reagent and calibrator/control stickers

Reagent and calibrator/control stickers (Sticker, Reagent Rack P400 HAX0230 (1207230230)) are
used to identify reagents, calibrators and controls on the racks. They are differentiated by a color
code:
■ White: reagent sticker
■ Yellow: calibrator sticker
■ Green: control sticker
10 = Reagent stickers
11 = Control stickers
12 = Calibrator stickers
User Manual 457

1.2. Sampling System
The sampling system includes a reagent syringe and a reagent needle for pipetting, preheating at
37°C +/- 0.5°C (99°F +/- 0.9°F) and dispensing reagents; a sample syringe and a sample needle for
pipetting and dispensing samples and reagents. Both needles are washed in their respective wash
towers between each sampling.
1 = Reagent syringe
2 = Sample syringe
3 = Sample needle
4 = Reagent needle
5 = Reagent needle wash tower
6 = Sample needle wash tower

motherboard when they are handled without ESD safe handling tools. Make contact with
the instrument ground (cover screw for example) before proceeding on needles in order to
prevent electrostatic discharges.
1.2.1. Syringes
Each syringe assembly consists of a glass barrel, a metal plunger fitted with a teflon tip, a valve and a
screw fitting to hold the syringe head.
Reagent syringe
This 1000 µL syringe controls the volume of reagents. It must be filled with water at all times and no
air bubbles should be visible in the syringe or tubing. This syringe performs samplings from 15 µL to
600 µL by steps of 0.1 µL.
Sample syringe
This 100 µL syringe controls the volume of sample, distilled water and additional reagents. It must be
filled with water at all times and no air bubbles should be visible in the syringe or tubing. This syringe
performs samplings from 2 µL to 95 µL by steps of 0.1 µL.
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1.2.2. Needles
Needles are sharp and may contain biohazardous materials. When opening the main
cover, wait for the arms to stop before proceeding.
Reagent needle
The reagent needle is a stainless steel needle with an external teflon coating and an internal sleeving
made of a teflon capillary tube from one end to the other.
The reagent needle preheats reagents at 37°C +/- 0.5°C (99°F +/- 0.9°F).
The reagent arm is equipped with capacitive level detection and insufficient volume detection.
The reagent needle is washed between each sampling in its wash tower.
Sample needle
The sample needle is a stainless steel needle with an external and internal teflon coating.
The sample arm is equipped with shock detection, the sample needle does not pierce neither sample
tubes nor sample cups.
Sample tubes or sample cups must always be uncapped before being positioned on the
sample tray or on the reagent tray.
The sample arm is also equipped with capacitive level detection, clot detection and insufficient
volume detection.
The sample needle is washed between each sampling in its wash tower.
1.2.3. Dilutions Management
Definitions
All volumes are in micro-litres (µL).
FD is the dilution factor.
FPre-dil is the pre-dilution factor.
FPost-dil is the post-dilution factor.
FPost-conc is the post-concentration factor.
SV is the sample volume.
H2OV is the H2O volume pipetted by the sample needle to push the sample volume (programmed in
the application).
DV is the diluent volume.
The sample needle can aspirate from 2.0 to 95 µL.
When possible, 300 µL of diluted material is prepared when using a cuvette. For example: if FD = 10.0,
30 µL of sample is pipetted and mixed with 270 µL of diluent. The total volume is 300 µL.
In some cases, this is not possible due to the limitations of pipetting volumes. For example: if
FD = 2.0, 95 µL of sample is pipetted and mixed with 95 µL of diluent. The total volume is not 300 µL
but 190 µL. This exception is true when 2.0 ≤ FD < 3.1.
User Manual 459

One or two cuvettes are used to perform dilution depending on FD.

■ If FD ≤ 150.0, then one cuvette is used for dilution.
If only one cuvette is required, sample volume and diluent volume are simply mixed in a cuvette as
shown in the figure below.
1 = SV
2 = DV
■ If FD > 150.0, then two cuvettes are used in series for dilution.
If two cuvettes are required, the first one is performed as above. For the second one, SV2 is
pipetted in the first cuvette and then mixed with DV2 in the second one as shown in the figure
below.
1 = SV1
2 = DV1
3 = SV2
4 = DV2
Dilution procedure
■ If 2.0 ≤ FD < 3.1, then one cuvette is used for dilution and:
SV = 95
DV = 95 * (FD - 1)
The total volume in the cuvette is then: 95 * FD
■ If 3.1 ≤ FD ≤ 150.0, then one cuvette is used for dilution and:
SV = 300 / FD
DV = SV * (FD - 1)
The total volume in the cuvette is then: 300 µL
■ If 150.0 < FD ≤ 22500.0, then two cuvettes are used in series for dilution and:
FDCuv = √ (FD)
SV = 300 / FDCuv
DV = SV * (FDCuv - 1)
The total volume in each cuvette is then: 300 µL
Post-dilution with no cuvette required

For a post-dilution, the sample volume and the H2O volume are adapted when possible in order not to
use cuvettes (the dilution is then performed in the needle).
In this case, the new SV and the new H2OV are calculated as follows:
New SV = SV / FD
New H2OV = New SV * {[FD * (SV + H2OV) / SV] - 1}
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1.3. Analytical Module
1.3.1. Cuvette Changer
The cuvette changer includes several parts:

■ The "new cuvette" holder with a 360-cuvette capacity.
■ The "used cuvette" holder with a 360-cuvette capacity.
■ The grabber, located behind the holders, for loading and unloading cuvettes into the reaction tray.

Switch the instrument off before any intervention on the grabber.
1 = "Used cuvette" holder

2 = "New cuvette" holder
Cuvette segments
Cassettes of 15 cuvette segments are used to fill the "new cuvette" holder (Cuvette Segments
A11A01891). Each disposable cuvette segment consists of 12 identically moulded cuvettes. The total
volume in a cuvette must be included between 150 µL to 600 µL.
■ Care should be taken in the storage and handling of the cuvette segments in order to
prevent breakage, damage or contamination.
■ Cuvette segments should be left in the plastic wrapping until use to prevent dust
contamination.
■ Cuvette segments should be handled only by the upper part.
■ Cuvette segments with at least one used cuvette must never be loaded in the reaction
tray.
Dispose of used cuvettes according to your local and/or national guidelines for biohazard
waste disposal.
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1.3.2. Reaction Tray
The reaction tray contains six positions, each position can hold a 12-cuvette segment for a total
capacity of 72 cuvettes.
The reaction tray is located in a chamber of which the temperature is regulated at 37°C +/- 0.2°C
(99°F +/- 0.36°F) by air circulation. A temperature sensor controls the temperature within the reaction
tray chamber. If the reaction tray temperature is out of range, the warning #123 Reaction tray
temperature exceeds limits or the alarm #053 Reaction Tray Temperature regulation failed is triggered.
1.3.3. Mixer
The mixer is a stainless steel paddle with an external teflon coating.

The mixer homogenizes reagents and samples in the cuvette. The mixing speed varies according to
the application.
The mixer paddle is washed between each use in its wash tower.
1 = Mixer paddle
2 = Mixer wash tower
1.3.4. Spectrophotometer
The Pentra C400 spectrophotometer disposes of 15 wavelengths: 340, 380, 405, 420, 455, 490, 505,
520, 550, 560, 580, 600, 620, 660, 700 nm.
Principle
White light from the tungsten-halogen lamp is collected by the condensing lens.
Once reflected by the folding mirror and shaped by the second lens, the white light beam passes
through the cuvette where it travels through the reactive solution.
White light emerging from the cuvette is then coupled with the spectrograph entrance slit by the third
lens.
The concave reflective grating spreads the incoming white light into monochromatic radiations and
reflects them onto the photodiode array.
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1 = Tungsten-halogen lamp
2 = Condensing lens
3 = Folding mirror
4 = Shaping lens
5 = Cuvette
6 = Coupling lens
7 = Spectrograph entrance slit
8 = Concave reflective grating
9 = Photodiode array
1.4. ISE Module (Option)
The ISE module (option) is designed to determine sodium, potassium and chloride concentrations in
serum, plasma or urine samples. It uses three Ion Selective Electrodes (ISE) for the measurement of
sodium, potassium and chloride concentrations and one reference electrode.
■ The sodium electrode consists of a glass membrane selective to Na+ ions.
■ The potassium electrode consists of a PVC crown ether membrane which is selective to K+ ions.
■ The chloride electrode is a plastic membrane electrode selective to Cl- ions.
■ The reference electrode consists of an open liquid junction.
The four electrodes are compact and located in a Faraday cage to minimize the influence of
electromagnetic fields. The electrodes are supplied ready to be used and no assembly is required.
To minimize environmental interferences, the ISE module cover must always be closed
during ISE module operation.
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Principle
Sodium, potassium and chloride are measured on:
■ undiluted serum and plasma samples,
■ diluted urine samples.
For serum and plasma samples, 60 µL of sample is pipetted by the sample needle and 50 µL is
dispensed into the ISE module sample cup. For urine samples, 20 µL of sample is pipetted by the
sample needle and 10 µL is dispensed and diluted with 60 µL of low standard directly into the ISE
module sample cup.
The sample flows through the air sensor to reach the ISE block. The air detection by air sensor
indicates the end of sample transfer from the sample cup to the ISE block. The reference solution
flows through the reference electrode and merges with the sample downstream of the ISE block.
The electrical potential is measured between each ion selective electrode and the reference electrode.
This measured potential is function of the ion concentration.
Valve 4 Valve 3 Valve 2 Valve 1

High standard
Low standard
Reference
Waste
Syringe 2 Syringe 1
Valve 6
High standard
Low standard
Reference
Air sensor
Ref Na+ Cl- K+
Sample cup
Valve 5
Isolator
Air
Waste
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1.5. Analysis Cycle Diagram
The figure below illustrates the Pentra C400 analysis cycle giving a mono-reagent/sample cycle
example.
Time (sec.) 0 1 2 3 4 5 6 7 8 9 10 11 12
Sample arm Sample

dispensing Washing
Sample Flush if necessary
pipetting
Sample syringe
Reagent Washing
Reagent arm dispensing
Reagent
pipetting
Reagent syringe
Mixing
Mixer
Automatic loading or
unloading of a cuvette
segment, if necessary
Reaction tray
Absorbance
reading Reading of
T0 Reading cuvettes 1 to 72
Reagent tray
Tray motion
Sample tray
Tray motion and
sample identification
if necessary
User Manual 465

Data Analysis
2. Data Analysis
2.1. Absorbance Measurements
2.1.1. Absorbance Values
Absorbance
A = log [(I0 - IB) / (I - IB)]
Where:
A is the absorbance.
I is the intensity measured.
I0 is the reference intensity. The reference intensity is measured for each wavelength during the
instrument initialization, it corresponds to the lamp intensity measured through a water-filled cuvette.
IB is the black intensity. The black intensity is measured for each wavelength during the instrument
initialization, it corresponds to the residual intensity measured in the black (the lamp is masked).
Bichromatism
The instrument measures the absorbance at two wavelengths.
■ The primary wavelength (λ1) is used to measure the component absorbance.
■ The secondary wavelength (λ2) is used to measure an absorbance due to a cuvette defect, a
variation of lamp intensity or some sample interferences.
AMeas = Aλ1 - Aλ2
Where:
AMeas is the absorbance measured.
Aλ1 is the absorbance measured at the primary wavelength.
Aλ2 is the absorbance measured at the secondary wavelength.
Volume correction
Absorbance values are corrected for volume differences if more than one pipetting step is performed
in a cuvette.
AEnd = AMeas * (VMeas / VEnd)
Where:
AMeas is the absorbance measured.
AEnd is the absorbance based on final total volume in the cuvette.
VMeas is the volume at time of measurement.
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Data Analysis
VEnd is the final total volume in the cuvette.
Checks
The three checks below are performed after the volume correction:
■ HIGH_ABS
■ SAMPLE_LIMIT
■ REAG_RANGE_HIGH / LOW
2.1.2. Calculation Types
2.1.2.1. Endpoint
Two absorbance readings are used to determine the reaction rate (ΔA).
ALast
ΔA
AFirst
Time
T0 Tn
A = ALast - AFirst
Where:
A is the absorbance.
AFirst is the first absorbance reading.
ALast is the last absorbance reading.
The checks below are performed for Endpoint calculation type:
■ DIV_ABSi
■ DIV_ABSf
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Data Analysis
2.1.2.2. Kinetic
Linear regression analysis is performed on all the measurement points included between the first and
the last absorbance readings. The slope of the regression line is the reaction rate (ΔA/min).
ALast
ΔA/min
AFirst
Time
TFirst TLast
ΔA/min = slope of the regression line between AFirst and ALast

Where:
ΔA/min is the reaction rate.
AFirst is the first absorbance reading.
ALast is the last absorbance reading.
The checks below are performed for Kinetic calculation type:
■ REAC_LIMIT
■ DIV_ABS
2.1.2.3. Kinsearch
For the determination of enzymatic activities, a linear search is performed on each cuvette to find the
linear range. Linear regression is then done on all the measurement points within this linear range. The
slope of the regression line is the reaction rate (ΔA/min).
If the change in absorbance between the first and the last absorbance readings is less
than 0.002 absorbance units, a linear regression (Kinetic calculation type) will be
performed instead of a linear search (Kinsearch calculation type) to determine the ΔA/min.
The following abbreviations are used:

A0 is the absorbance value at time of the first reading.
A1, A2, ... is the absorbance value at each time interval.
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Data Analysis
An is the absorbance value at time of the last reading.

Δa is the absorbance difference between A1 and A0.
Δb is the absorbance difference between A2 and A1.
Δc is the absorbance difference between A3 and A2.
Δd is the absorbance difference between A4 and A3.
T0 is the first reading cycle.
T1, T2, ... is each reading cycle.
Tn is the last reading cycle.
Two linear search programs are used.
■ The special program applies if the curve complies with the following conditions: decreasing curve
(A0 > A1) and non-linear beginning of curve (0.9 * Δa > Δb).
■ The normal program is used for all other curves.
Special program
To find the end of the linear range, the consecutive absorbance changes are compared until the
following absorbance change becomes greater than or equal to the previous one.
Δa > Δb
Δb > Δc
Δc ≤ Δd
The measurement point used in both intervals is established as point I.
An auxiliary point end (APE) is set 12 seconds prior to I in time and at the same absorbance as I.
To find the end of the linear range, straight lines are drawn from the point APE to each absorbance
point, in sequence starting with An. The tangents of the angles formed by each of these lines are
sequentially compared.
Tangent of angle = ΔAbsorbance / ΔTime
Example: tn (αn) = (An - A3) / (Tn - T3 + 12 sec)
tn (αn) < tn (αn-1)
tn (αn-1) < tn (αn-2)
tn (αn-2) < tn (αn-3)
tn (αn-3) < tn (αn-4)
tn (αn-4) ≥ tn (αn-5)
When the tangent of the compared angle becomes less than or equal to the previous tangent, the
point used to draw the associated line is defined to be the end (E) of the linear range.
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Data Analysis
A0
Δa
A1
Δb
A2
Δc APE I
A3
Δd
A4
αn-4 αn-2 αn
αn-5 αn-3 αn-1
E
12 sec
An
Time
T0 T1 T2 T3 T4 ... Tn-4 Tn-3 Tn-2 Tn-1 Tn
To find the beginning of the linear range, an auxiliary point beginning (APB) is set 12 seconds prior to
E in time and at the same absorbance as E.
Straight lines are drawn from the point APB to each absorbance point, in sequence starting with A0.
The tangents of the angles formed by each of these lines are sequentially compared.
Tangent of the angle = ΔAbsorbance / ΔTime
Example: tn (α0) = (An-5 - A0) / (Tn-5 - T0 - 12 sec)
tn (α0) > tn (α1)
tn (α1) ≤ tn (α2)
When the tangent of the compared angle becomes greater than or equal to the previous tangent, the
point used to draw the associated line is defined to be the beginning (B) of the linear range.
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Data Analysis
A0
A1 B
A2
α0
α1
α2
E
APB
12 sec
An
Time
Normal program
To find the end of the linear range, an auxiliary point end (APE) is set 12 seconds prior to A0 in time
and at the same absorbance as A0.
Straight lines are drawn from the point APE to each absorbance point, in sequence starting with An.
Example: tn (αn) = (An - A0) / (Tn - T0 + 12 sec)
tn (αn) < tn (αn-1)
tn (αn-1) < tn (αn-2)
tn (αn-2) ≥ tn (αn-3)
point used to draw the associated line is defined to be the end (E) of the linear range.
User Manual 471

Data Analysis
A
An
αn
αn-1
αn-2
αn-3
APE
A0
12 sec
Time
To find the beginning of the linear range, an auxiliary point beginning (APB) is set 12 seconds after An
in time and at the same absorbance as An.
Straight lines are drawn from the point APB to each absorbance point, in sequence starting with A0.
Example: tn (α0) = (An - A0) / (Tn - T0 + 12 sec)
tn (α0) < tn (α1)
tn (α1) < tn (α2)
tn (α2) < tn (α3)
tn (α3) ≥ tn (α4)
point used to draw the associated line is defined to be the beginning (B) of the linear range.
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Data Analysis
APB
An
E
α1 α2 α3 α4 α5
12 sec
A0
Time
The checks below are performed for Kinsearch calculation type:

■ NON_LIN
■ NOISE
■ REAC_LIMIT
■ DIV_ABS
2.1.2.4. Absorbance Deviation Checks
The absorbance deviation checks are performed during the reaction rate calculation in order to flag
optical density jumps.
DIV_ABSi
This check is only available for the Endpoint calculation type.
The goal of this check is to verify that the absorbance difference between the first point and a
reference point is included in a defined range.
Two different algorithms can be used for this check: one if the first reading cycle < 4, another if the
first reading cycle ≥ 4.
■ First reading cycle < 4
User Manual 473

Data Analysis
Reagent blank
A Normal run
An of reagent blank
blank range high
blank range low
A0 of run
T0 Tn Time
The difference |An of reagent blank - A0 of run| is calculated and checked to ensure that it is
included in the configured blank range. If not, the analytical flag DIV_ABSi is triggered.
Where:
A0 is the absorbance value at the first reading cycle.
An is the absorbance value at the last reading cycle.
■ First reading cycle ≥ 4
An
A0-1
A0
D1
T0 Tn Time
Three absorbance differences are calculated as follows:

D1 = |A0 - A0-1|
D2 = |A0 - A0-2|
D3 = |A0 - A0-3|
Where:
D1, D2, D3 are the absorbance differences.
A0 is the absorbance value at first reading cycle.
A0-1, A0-2, A0-3 is the absorbance value at the first reading cycle -1, -2, -3.
The three calculated absorbance differences are checked to ensure that they are lower than the
configured first point threshold. If at least two absorbance differences are greater than or equal to
the configured threshold, the analytical flag DIV_ABSi is triggered.
DIV_ABSf
This check is only available for the Endpoint calculation type.
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Data Analysis
The goal of this check is to verify that the absorbance difference between the last point and the
previous one is included in a calculated range.
A
D1
An-6 An-4 An-2 An
T0 Tn-6 Tn-4 Tn-2 Tn Time
1. The ten last absorbance differences are calculated as follows:

D1 = |An - An-1|; D2 = |An-1 - An-2|
D3 = |An-2 - An-3|; D4 = |An-3 - An-4|
D5 = |An-4 - An-5|; D6 = |An-5 - An-6|
D7 = |An-6 - An-7|; D8 = |An-7 - An-8|
D9 = |An-8 - An-9|; D10 = |An-9 - An-10|
Where:
D1, D2, ... are the absorbance differences.
n are the last reading cycles.
An, An-1, An-2, ... is the absorbance value at time n, n-1, n-2, ...
The two highest absorbance differences are not taken into account in the next step.
2. The mean DMean and the standard deviation SD of absorbance differences are calculated as
follows:
■ Mean DMean:
DMean = ∑Dx / a
Where:
DMean is the mean absorbance difference.
a is the number of absorbance differences taken into account (a = 8).
∑Dx is the sum of the absorbance differences taken into account.
■ Standard deviation SD:
SD = √ {[a * ∑Dx2 - (∑Dx)2] / [a * (a - 1)]}
Where:
SD is the standard deviation of absorbance differences.
a is the number of absorbance differences taken into account (a = 8).
∑Dx is the sum of the absorbance differences taken into account.
∑Dx2 is the sum of squares of the absorbance differences taken into account.
3. D1 is checked to ensure that it is included in a range calculated as follows:
[DMean - FSD * SD; DMean + FSD * SD ]
Where:
D1 is the absorbance difference between the last point and the previous one.
DMean is the mean absorbance difference.
SD is the standard deviation of absorbance differences.
FSD is the SD factor (set to 30 by default).
If not, the analytical flag DIV_ABSf is triggered.
User Manual 475

Data Analysis
This algorithm applies only when the last reading cycle is ≥ 11.
DIV_ABS
This check is only available for Kinetic and Kinsearch calculation types.
The goal of this check is to calculate the correlation coefficient r2 of the reaction and to flag any
reaction with a r2 lower than 0.80.
An
r2
T0 Tn Time
The correlation coefficient r2 and the standard deviation SD are calculated as follows:
■ Correlation coefficient r2:
r = (b * ∑XY - ∑X * ∑Y) / √ {[b * ∑X2 - (∑X)2] * [b * ∑Y2 - (∑Y)2]}
Where:
r2 is the correlation coefficient.
b is the number of measurement points used for the linear regression.
X is the absorbance values of the used measurement points.
Y is the times in seconds of the used measurement points.
∑X is the sum of absorbance values of the used measurement points.
∑Y is the sum of times in seconds of the used measurement points.
∑X2 is the sum of squares of absorbance values of the used measurement points.
∑Y2 is the sum of squares of times in seconds of the used measurement points.
∑XY is the sum of absorbance values multiplied by times in seconds of the used measurement
points.
■ Standard deviation SD:
SD = √ {[b * ∑X2 - (∑X)2] / [b * (b - 1)]}
Where:
SD is the standard deviation.
b is the number of measurement points used for the linear regression.
X is the absorbance values of the used measurement points.
∑X is the sum of absorbance values of the used measurement points.
∑X2 is the sum of squares of absorbance values of the used measurement points.
■ For the Kinetic calculation type, the measurement points used to calculate r2 and SD
are those included between the first reading cycle and the last reading cycle.
■ For the Kinsearch calculation type, the measurement points used to calculate r2 and
SD are those included in the linear range found within the linear search program.
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Data Analysis
If r2 is lower than the configured r2 threshold (set to 0.80 by default) and SD is higher than the
configured SD threshold, then the analytical flag DIV_ABS is triggered.
2.1.3. Rates
Reagent blank correction

If a reagent blank is programmed in the application, all rates (ΔA or ΔA/min) are corrected for the
reagent blank absorbance change.
This correction applies to rates of calibrator, control and patient sample.
R = ΔA - ΔARB
Where:
R is the corrected rate of calibrator, control or patient sample.
ΔA is the absorbance difference or rate of calibrator, control or patient sample.
ΔARB is the absorbance difference of reagent blank.
The reagent blank absorbance change is stored in memory until another calibration is
performed.
Sign correction
If the reaction direction is programmed as decreasing in the application, the calculated rate is
multiplied by (- 1) to make the rate a positive number.
This correction applies to rates of calibrator, control and patient sample and occurs before the
reaction direction check.
R' = R * (- 1)
Where:
R is the rate of calibrator, control or patient sample.
R' is the corrected rate of calibrator, control or patient sample.
Rate correction factor for recalibrations

For the Linear regression calibration mode and non-linear calibration modes, if a recalibration with a
single calibrator level is performed, the calculated rate correction factor applies to rates of control and
patient sample.
R'' = R' * FRC
Where:
R' is the rate of control or patient sample.
R'' is the corrected rate of control or patient sample.
FRC is the rate correction factor.
The rate correction factor FRC is calculated as follows:
FRC = ROld / RNew
Where:
ROld is the old calibrator rate.
RNew is the new calibrator rate.
FRC is the rate correction factor.
User Manual 477

Data Analysis
Checks
The three checks below are performed after rate corrections:
■ BLK_RANGE
■ SIGN
■ HIGH_ACTIV
2.1.4. Calibration Modes
Mean rate calculation

When using calibration modes with one or more standards, every standard can be run once, twice or
three times. The replicate rates are averaged to provide a mean rate for the standard.
The example below illustrates the use of three replicates:
RStd-n = (RStd-n1 + RStd-n2 + RStd-n3) / 3
Where:
RStd-n is the mean rate of standard n.
RStd-n1 is the first run rate of standard n.
RStd-n2 is the second run rate of standard n.
RStd-n3 is the third run rate of standard n.
Calibration modes
The calibration modes used on the Pentra C400 are described in the chapters below:
■ Factor
■ Slope average
■ Linear regression
■ Linear interpolation
■ Multiparameter mathematical algorithms (LOGIT/LOG4, LOGIT/LOG5 or EXPONENT5)
Checks
The checks below are performed on calibrations:
■ CALCHK_FLAG
■ CALCHK_ERROR
■ CALC_ERROR
■ CAL_NOT_OPTIMISED
■ FACTOR_FLAG
■ Factor, p.478
■ Slope Average, p.479
■ Linear Regression, p.480
■ Linear Interpolation, p.480
■ Multiparameter Mathematical Algorithms (LOGIT/LOG4, LOGIT/LOG5 or EXPONENT5), p.481
2.1.4.1. Factor
A theoretical factor is entered in the application to multiply the calculated rate to obtain test results.
■ For enzyme activities:
U/L = ΔA/min * F
478 User Manual

Data Analysis
Where:
F is the theoritical factor.
ΔA/min is the rate.
U/L is the result.
■ For concentrations:
C = ΔA * F
Where:
F is the theoretical factor.
ΔA is the rate.
C is the result.
2.1.4.2. Slope Average
This calibration mode is used for assays when the observed change in absorbance and the
concentration of the analyte have a linear relationship.
One to three standards can be programmed to derive the factor required in order to calculate test
results.
The example below illustrates the use of three standards:
Rate
RStd-3
RS
RStd-2
RStd-1
Conc.
CStd-1 CStd-2 CS CStd-3
F = (CStd-1 / RStd-1 + CStd-2 / RStd-2 + CStd-3 / RStd-3) / 3

CS = RS * F
Where:
CStd-1, CStd-2, CStd-3 is the known concentration of standard 1, 2 or 3.
RStd-1, RStd-2, RStd-3 is the rate of standard 1, 2 or 3.
F is the calculated factor.
RS is the rate of control or patient sample.
CS is the concentration of control or patient sample.
User Manual 479

Data Analysis
2.1.4.3. Linear Regression
For linear calibration curves, two to eight standards can be programmed to derive the curve
parameters required in order to calculate test results.
Linear regression is performed through all data points to find the most corrected line.
Rate
Individual
data point
R0
Conc.
R = a * C + R0
C = (R - R0) / a
Where:
R is the rate of control or patient sample.
a is the slope of the regression line.
R0 is the intercept of the regression line.
C is the concentration of control or patient sample.
2.1.4.4. Linear Interpolation
For non-linear calibration curves, three to eight standards can be programmed to derive the curve
parameters required in order to calculate test results.
Linear interpolation amounts to draw a straight line from standard to standard.
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Data Analysis
Rate
Std-3
Std-2
RS
Std-1
Conc.
CS
CS = (RStd-L - RS) * (CStd-H - CStd-L) / (RStd-L - RStd-H) + CStd-L

RStd-L is the rate of the previous lower standard.
RStd-H is the rate of the next higher standard.
RS is the rate of the control or patient sample.
CStd-L is the concentration of the previous lower standard.
CStd-H is the concentration of the next higher standard.
CS is the concentration of the control or patient sample.
2.1.4.5. Multiparameter Mathematical Algorithms (LOGIT/LOG4, LOGIT/

LOG5 or EXPONENT5)
These calibration modes are used for assays when the observed change in absorbance and the
concentration of the analyte does not follow a linear relationship.
Calibration Standard Function Parameters

mode number
LOGIT/LOG4 From 4 to 8 R = R0 + KC / {1 + exp [- (a + b * lnC)]} R0, KC, a, b
LOGIT/LOG5 From 5 to 8 R = R0 + KC / {1 + exp [- (a + b * lnC + c * C)]} R0, KC, a, b, c
EXPONENT5 From 5 to 8 R = R0 + K * exp [a * lnC + b * (lnC)2 + c * (lnC)3] R0, K, a, b, c
Where:
R0 is the predicted rate for a standard with zero concentration.
R is the rate of control or patient sample.
KC is the scale parameter for LOGIT/LOG4 and LOGIT/LOG5 (= difference between the predicted rate
for a standard with infinite concentration and R0).
K is the scale parameter for EXPONENT5.
a, b, c are various parameters which define the non-linear elements of each mathematical function.
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Data Analysis
2.1.5. Results
Concentration calculation
The conversion of rates to concentrations is based on a function which depends on the calibration
mode programmed. The function parameters are derived from the standard rates and concentrations
except for the factor calibration mode.
Calibration mode Function

Factor U/L = ΔA/min * F
C = ΔA * F
Slope average CS = RS * F
Linear regression C = (R - R0) / a
Linear interpolation CS = (RStd-L - RS) * (CStd-H - CStd-L) / (RStd-L - RStd-H) + CStd-L
LOGIT/LOG4 R = R0 + KC / {1 + exp [- (a + b * lnC)]}
LOGIT/LOG5 R = R0 + KC / {1 + exp [- (a + b * lnC + c * C)]}
EXPONENT5 R = R0 + K * exp [a * lnC + b * (lnC)2 + c * (lnC)3]
For detailed information concerning the calibration modes, refer to the Absorbance
Measurements > Calibration Modes chapter.
Result correlation
A correlation factor and an offset can be entered in the application to convert results in order to
correlate them with an alternative method or another temperature. The correlation factor and the
offset correspond respectively to the slope (A) and the intercept (B) of the regression line y = A * x + B
determined by a correlation study between the two methods.
y=A*x+B
Where:
A is the correlation factor or slope (A) of the regression line.
B is the offset or intercept (B) of the regression line.
x is the concentration of calibrator, control or patient sample.
y is the correlated concentration of calibrator, control or patient sample.
Two result correlations are programmable in the application: one dedicated to the user, another
dedicated to HORIBA Medical.
Unit conversion factor

The unit conversion factor is the conversion factor between the reference unit and the unit chosen to
display the results. It applies to results in order to express them in the concentration unit chosen by
the user.
C’ = C * FU
Where:
F is the unit conversion factor.
C is the concentration of calibrator, control or patient sample.
C' is the converted concentration of calibrator, control or patient sample.
482 User Manual

Data Analysis
Checks
The checks below are performed on results:
■ DEVIATION
■ RESULT_CALC_ERR
■ CALC_RANGE_HIGH / LOW
■ TEST_RANGE_HIGH / LOW
■ AG_EXCESS
■ CONF_RANGE_HIGH / LOW
WESTGARD_RULE_4-6
■ Calibration Modes, p.478
2.2. Electrolyte Measurements
2.2.1. Principle
The measurement principle of the ISE module is based on the interaction between moveable free ions
in a sample solution and an active sensing unit (ion selective sensing electrode).
An ion selective membrane separates the sample solution, where the electrolyte concentration is
unknown, from the electrode electrolyte, where the concentration is known.
1 = Reference electrode
2 = Selective electrode (for the ion measured)
3 = Electrolyte (known concentration)
4 = Voltage measurement
5 = Selective membrane
In order to measure this potential change, a reference electrode with a fixed potential is immersed in
the same solution. The potential of the reference electrode is kept fixed and constant, by filling it with
an electrolyte that has a constant concentration.
User Manual 483

Data Analysis
The electrical potential is measured between each ion selective electrode and the reference electrode.
This measured potential is function of the ion concentration.
The potential of an ion selective electrode depends on the logarithm of the activity of this ion. This
relationship is described by the Nernst equation:
E = E0 + S * log ai
Where:
E is the measured potential between ion selective electrode and reference electrode.
E0 is the standard potential of electrode assembly.
S is the electrode slope (Nernst factor).
ai is the activity of measured ion.
S = (2.303 * R * T) / (n * F)
Where:
2.303 is the conversion factor for ln to log.
R is the gas constant.
T is the absolute temperature (°K).
n is the Valency of the ion.
F is the Faraday constant.
If the ionic strength of the calibration solution is equal to that of the sample, the electrode system can
be calibrated with accuracy using concentration instead of activity.
E = E0 + S * log C
Where:
E is the measured potential between ion selective electrode and reference electrode.
E0 is the standard potential of electrode assembly.
C is the concentration of measured ion.
Relative measurements are performed to eliminate temperature influence.
2.2.2. Calibration
The slope of the measuring system is defined as being the variation in voltage obtained when the ion
concentration is multiplied by 10. It is determined by measuring two different standard solutions.
Taking into account the logarithm relationship between concentration and voltage in the Nernst
equation, the slope is calculated as follows.
S = (EStd-1 - EStd-2) / log (CStd-1 / CStd-2)
Where:
EStd-1, EStd-2 is the measured potential of Standard 1 or Standard 2.
CStd-1, CStd-2 is the known concentration of Standard 1 or Standard 2.
S is the slope.
The slope is checked to ensure that it is included in the slope normal range.
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Data Analysis
2.2.3. Results
Concentration calculation
The unknown concentration is calculated by comparing the measured potential with the potential of
the standard solution which has a known concentration.
C = CStd-1 * 10^[(E - EStd-1) / S]
Where:
EStd-1 is the measured potential of Standard 1.
E is the measured potential of control or patient sample.
CStd-1 is the known concentration of Standard 1.
S is the slope.
Result correlation
A correlation factor and an offset can be entered in the application to convert results in order to
correlate them with an alternative method or another temperature. The correlation factor and the
offset correspond respectively to the slope (A) and the intercept (B) of the regression line y = A * x + B
determined by a correlation study between the two methods.
y=A*x+B
Where:
A is the correlation factor or slope (A) of the regression line.
B is the offset or intercept (B) of the regression line.
x is the concentration of calibrator, control or patient sample.
y is the correlated concentration of calibrator, control or patient sample.
Unit conversion factor

The unit conversion factor is the conversion factor between the reference unit and the unit chosen to
display the results. It applies to results in order to express them in the concentration unit chosen by
the user.
C’ = C * FU
Where:
F is the unit conversion factor.
C is the concentration of calibrator, control or patient sample.
C' is the converted concentration of calibrator, control or patient sample.
Checks
The checks below are performed after the unit conversion:
■ CONF_RANGE_HIGH / LOW
WESTGARD_RULE_4-6
User Manual 485

Data Analysis
486 User Manual

Index
A Background Noise, 17
Absorbance deviation checks, 473 Barcode position, 102
Absorbance measurements, 466 Barcode reader configuration, 304, 315
AG_EXCESS, 441 Barcode
Alarms Print Recommendations, 102
Analytical flags, 423 BLK_RANGE, 426
ISE analytical flags, 445 Buttons description, 50
ISE error codes, 448
Maintenance alerts, 329, 330 C
Quality flags, 444 CALCHK_ERROR, 434
Sampling alarms, 420 CALCHK_FLAG, 433
Sound alarms, 328 Calculation types
System alarms, 401 Endpoint, 467
System warnings, 401 Kinetic, 468
System Warnings menu, 400 Kinsearch, 468
Temperature alarms, 417 CALC_ERROR, 434
Alerts configuration, 329, 330 CALC_RANGE_HIGH / LOW, 438
Analysis cycle, 465 Calibration modes, 478
Analytical flags, 423 EXPONENT5, 481
ISE analytical flags, 445 Factor, 478
Priority, 444 Linear interpolation, 480
Test Review, 133, 183 Linear regression, 480
Applications LOGIT/LOG4, 481
Absorbance parameters, 253 LOGIT/LOG5, 481
Addition, 272, 273 Slope average, 479
Analysis parameters, 265 Calibration
Calculation parameters, 267 Analyses start, 129, 175
Calibration parameters, 260 Deletion, 148
Configuration, 252 ISE module, 114, 250, 251
Deletion, 275 Requests addition, 118
General parameters, 254 Requests deletion, 119
ISE parameters, 275 Rerun, 147
Major parameters, 282 Results conversion, 149
Minor parameters, 282 Results interpretation, 138, 144
Modification, 274, 279 Results printout, 148
Order configuration, 280 Results problem, 392
Unit parameters, 271 Results validation, 138, 142, 145
Update, 280 Tests selection, 117, 120, 162
User parameters, 282 Time lapse configuration, 310
Archives, 199 Worklist, 117
Archive files save on a USB key, 203 Calibrator
Results save on a USB key, 204 Addition, 232, 233, 234
Results search by patient, 201 Change, 234, 238, 239
Results search by worklist/SID, 200 Characteristics, 232, 238
Results search in the archive files, 202 Configuration, 232, 236
Audible alarms, 328 Deletion, 240, 241
Loading, 123
B Lot number change, 238
Back-up cassette, 221 MSDS, 40
Configuration, 309 Notice, 40
User Manual 487

Position, 234, 241 Target values, 242, 248, 249
Reagent rack in red, 373 Tests selection, 117, 120, 162
Reagent rack not displayed, 374 Upload, 245
Sample in red, 376 Worklist, 120
Target values, 233, 239, 240 Cooling unit
Upload, 236 Bimonthly maintenance, 352
CAL_NOT_OPTIMISED, 434 Condenser cleaning, 351
Cassette Configuration, 309
Activation, 223 Connections, 24
Deactivation, 223 Glycol level check, 352
Screen, 221 Monthly maintenance, 351
Cleaning, 368 Problem, 390
Cleaning configuration, 306 Copyright, 10
Client parameters CRITICAL_RANGE_HIGH / LOW, 443
Restoration, 317 Customer parameters
Save, 316 Restoration, 317
Columns configuration, 58 Save, 316
Computer, 36 Customer Services menu, 336
Connections, 25 Cuvette changer
CONF_RANGE_HIGH / LOW, 441 "New cuvette" holder, 105, 213
CONF_RANGE_HIGH_W / LOW_W, 442 "Used cuvette" holder, 105, 213
CONF_RANGE_HIGH_W1-6 / LOW_W1-6, Configuration, 303
442 Cuvette segments, 461
Connections Cuvettes manual loading, 383
Cooling unit, 24 Deactivation, 383
Peripherals, 25 Description, 461
Power supply, 23 Operation check, 382
Waste, 24 Problem, 380
Water, 24 Cuvette segments, 461
Consumables, 369 Cuvette Status button, 54
Control
Addition, 242, 244 D
Analyses start, 129, 175 Database restoration, 318
Change, 244, 247, 248 Date
Characteristics, 242, 247 Change, 313
Close, 249 Format, 312
Configuration, 241, 245 Declaration of Conformity, 8
Deletion, 155, 249 Decontamination, 368
Loading, 123 DEVIATION, 435
Lot number change, 247 Dilutions management, 459
MSDS, 40 Dimensions, 39
Notice, 40 Disposal
Position, 244, 249 Accessories, 18
Reagent rack in red, 373 Consumables, 18
Reagent rack not displayed, 374 Instrument, 18
Requests addition, 121, 122 DIV_ABS, 430
Requests deletion, 123 DIV_ABSf, 432
Rerun, 154 DIV_ABSi, 431
Results interpretation, 151
Results printout, 155 E
Results problem, 393 Electrode configuration, 308
Results transmission to host, 156 Electromagnetic Environment Check, 17
Results validation, 150, 152 Electronic and Moving Parts, 13
Sample in red, 376 Endpoint, 467
488 User Manual

Environment, 16 Status, 51
Environmental Protection, 18 Interferences, 43
European Legislation, 40 ISE analytical flags, 445
EXPONENT5, 481 ISE_ERROR, 446
Offset error, 446
F Repeatability error, 446
Factor, 478 Response error, 446
FACTOR_FLAG, 434 Sensibility error, 445
Filter replacement, 354 ISE module
Flags Activation, 110
Analytical flags, 423 Calibration, 114, 115, 250, 251
ISE analytical flags, 445 Calibration results interpretation, 116
Priority, 444 Cleaning, 339, 341
Quality flags, 444 Configuration, 308
Fuses replacement, 372 Control results problem, 395
Daily maintenance, 339
G Description, 463
Generic toolbar, 50 Electrodes replacement, 363
Grounding, 17 Error on ISE calibration, 388
ISE analytical flags, 445
H ISE error codes, 386, 448
Help, 50, 59 ISE reagents replacement, 363
Update, 315 Keep ready, 250, 251
HIGH_ABS, 423 Measurements, 483
HIGH_ACTIV, 428 Mechanical error, 387
Host Patient results problem, 396
Communication frames, 321 Ready, 250, 251
Configuration, 319 Reagent/fluidic error, 387
Connection, 25 Shutdown for over 3 days, 365
Connection check and reset, 320 Shutdown within 3 days, 365
Connection parameters, 319 Startup, 366
Connection test, 320 Status, 114, 386
Initialization special message, 419 Weekly maintenance, 341
Orders purge, 320 ISE reagents check, 105, 213
Query Mode, 319 ISE_ERROR, 446
Results transmission, 319
Search, 321 K
Humidity conditions, 17, 38 Keyboard configuration, 314
Kinetic, 468
I Kinsearch, 468
Incompatibility
Addition, 295 L
Configuration, 293 Labels
Deletion, 296 Cassettes, 30, 455
Modification, 296 Racks, 30, 456
Parameters, 294 Tubes, 102
Initialization special message, 419 Lamp
Installation, 19 Gain check failed, 385
Instrument Replacement, 361
Description, 452 Stability problem, 384
Login, 108 Language configuration, 314
Overview, 21 Level detection configuration, 302
Shutdown, 214 Light stability problem, 384
Startup, 107 Linear interpolation, 480
User Manual 489

Linear regression, 480 Mixer
LINEARITY_HIGH / LOW, 437 Cleaning, 343
Login, 108 Description, 462
LOGIT/LOG4, 481 Paddle replacement, 360
LOGIT/LOG5, 481 Weekly maintenance, 343
Logos
Definition, 9 N
Logs, 86 Needle
Applications, 88 Problems, 378
Calibration, 86 Needles
Error, 87 Cleaning, 340, 343
Maintenance, 90, 91 Daily maintenance, 340
Reagent, 87 Description, 459
Sequencing, 88 Monthly maintenance, 344
System configuration, 87 Reagent needle cleaning, 344
Reagent needle replacement, 356
M Sample needle replacement, 358
Main menu, 46 Temperature problem, 379
Maintenance, 339 Weekly maintenance, 343
Alerts configuration, 329, 330 NOISE, 428
Bimonthly maintenance, 352, 354 NON_LIN, 427
Cleaning, 368 Notice of Liability, 8
Cooling unit condenser cleaning, 351
Daily maintenance, 339, 340 O
Decontamination, 368 Offset error, 446
Electrodes replacement, 363 Open cassette
Filter replacement, 354 Activation, 226
Glycol level check, 352 Deactivation, 226
ISE module cleaning, 339, 341 Deletion, 227
ISE module shutdown, 365 Screen, 225
ISE module startup, 366
ISE reagents replacement, 363 P
Lamp replacement, 361 Package Content, 19
Logs, 90, 91 Patient sample
Mixer cleaning, 343 Analyses start, 129, 175
Mixer paddle replacement, 360 Archive files save on a USB key, 203
Monthly maintenance, 344, 346, 348, Archives, 199
349, 351 Batch mode, 164
Needles cleaning, 340, 343 Loading, 169
Reagent needle cleaning, 344 Patient ID, 158
Reagent needle replacement, 356 Request capture screen, 161
Sample needle replacement, 358 Request modification, 168
Syringe plunger tips replacement, 346 Requests addition by barcode
Syringes replacement, 355 identification, 166
Test P1, 349 Requests addition by position, 162
Test T1, 348 Requests addition from the host, 167
Wash towers cleaning, 344 Requests addition in batch mode, 164
Weekly maintenance, 341, 343 Requests deletion, 169
Measurements Results interpretation, 188
Absorbance, 466 Results printout, 194, 197
ISE module, 483 Results problem, 394
Menu access buttons, 52 Results save on a USB key, 204
Menus description, 47 Results search by patient, 201
Results search by worklist/SID, 200
490 User Manual

Results search in the archive files, 202 R
Results transmission to host, 198 Racks configuration, 307
Results validation, 188, 191 Ratios
Stat run, 176 Addition, 287, 288
Tests addition, 193 Configuration, 284
Tests selection, 117, 120, 162 Deletion, 289
Worklist, 158 Modification, 289
Pictograms Parameters, 285
Definition, 9 Sub-ratio, 290, 291
Power Reaction tray
Problem, 372 Description, 462
Requirements, 38 Door open, 384
Supply, 38 Noise, 381
Precautions, 12 Temperature problem, 384
Pressure detection REAC_LIMIT, 429
Calibration, 347, 355 Reagent blank
Configuration, 304 Deletion, 148
Printer operation problems, 373 Rerun, 147
Printer, 32 Results interpretation, 144
Connection, 25 Results printout, 148
Default printer, 325 Results validation, 138, 145
Deletion, 325 Reagent help, 50
Properties, 324 Reagent tray access, 111
Startup, 106 Reagent tray description, 111, 452
Switching off, 216 Reagent tray problem, 373
Printouts Cassette in red, 373
Configuration, 323 Cassette not displayed, 374
Headers, 323 Cover open, 374
Profiles Reagent rack in red, 373
Addition, 292 Reagent rack not displayed, 374
Configuration, 291 Temperature, 374
Deletion, 293 Reagent
Modification, 292 Addition on a reagent rack, 229
Cassette activation, 223
Q Cassette deactivation, 223
Quality Control Cassette in red, 373
Annual control results, 63, 73 Cassette not displayed, 374
Annual values interpretation, 66, 76 Cassette screen, 221
By control, 63 Configuration, 219
By test, 73 Deletion, 300
Export for QCP, 71 Deletion on a reagent rack, 230
Graphs interpretation, 67, 77 Identification, 35
Monthly control results, 63, 73 Lot number change in an open
Monthly values interpretation, 65, 75 cassette, 226
Overview, 62 Lot number change on a reagent rack,
Printout, 69, 79 230
Session control results, 63, 73 Management, 218
Session values interpretation, 64, 74 Modification, 299
Quality flags, 444 MSDS, 40
Priority, 445 Notice, 40
Test Review, 133, 183 On board capacity, 35
Query Mode On board temperature, 35
Configuration, 319 Open cassette activation, 226
Open cassette deactivation, 226
User Manual 491

Open cassette deletion, 227 Sample in red, 376
Open Cassette screen, 225 Sample
Packaging, 34 Dilution, 35
Parameters, 298 Identification, 35, 302
Performance, 41 On board capacity, 35
Preheating, 35 Rack in red, 375
Reagent rack activation, 229 Rack not displayed, 375
Reagent rack deactivation, 229 Rack wrongly displayed, 375
Reagent rack in red, 373 Sample ID, 159
Reagent rack not displayed, 374 Sample in red, 376
Reagent Rack screen, 228 Status, 178, 179
Recommendations, 40 Tube, 35
Registration, 297, 299 Type, 35, 102
Status, 111, 112, 219 Volume, 35, 102
Volume, 35 Workflow, 178
Work Balance, 125, 171 SAMPLE_LIMIT, 424
REAG_RANGE_HIGH / LOW, 425 Sampling alarms, 420
References Test Review, 132, 182
Consumables, 369 Work Balance, 126, 172
Spare parts, 369 Sampling system description, 458
REF_RANGE_HIGH / LOW, 443 Dilutions management, 459
Repeatability error, 446 Needles, 459
Reproducibility problem, 379 Syringes, 458
Response error, 446 Sampling system problem
Results export Needles, 378
Configuration, 310 Reagent needle temperature, 379
Manual export, 137, 187 Reproducibility, 379
Results problem Syringes, 378
Calibration, 392 Scientific notation, 58
Control, 393 Sensibility error, 445
ISE module, 395, 396 Serial number label, 23
Patient sample, 394 Serial number
Results transmission to host, 319 Configuration, 302
Results validation Shutdown, 214
Calibration, 138 Instrument check, 105, 213
Configuration, 326, 327 Worklist check, 212
Control, 150 SIGN, 430
Patient, 188 Slope average, 479
Reagent blank, 138 Software
Westgard rules, 326 Buttons Description, 50
RESULT_CALC_ERR, 436 Columns configuration, 58
Contextual buttons, 55
S Cuvette Status button, 54
Sample barcode reader Finish time, 54
Barcode label, 377 Generic toolbar, 50
Check, 376, 377 Menu access buttons, 52
Problem, 376, 377 Menus description, 47
Sample tray description, 178, 453 Overview, 46
Sample tray problem, 375 Reagent tray, 111
Barcode label, 377 Sample tray, 178
Barcode reader, 376, 377 Scientific notation, 58
Rack in red, 375 Start time, 54
Rack not displayed, 375 Status buttons, 54
Rack wrongly displayed, 375 Sound alarms, 50, 328
492 User Manual

Sound level, 39 Format, 313
Spare parts, 369 Trademarks, 8
Spectrophotometer Transportation, 18
Description, 462 Tubes Labelling, 102
Gain check, 385
Standby mode, 206 U
Configuration, 207, 305 Users
Manual, 206 Addition, 332
Startup, 208 Change in a working day, 208
Start, 129, 175 Deletion, 333
Startup, 107 Levels, 331
Configuration, 305 Modification, 332
Instrument check, 105, 213
Stat run, 176 W
Status buttons, 54 Warnings, 401
Storage Conditions, 18 Warranty, 12
Switching off Wash towers
Printer, 216 Cleaning, 344
Symbols definition Monthly maintenance, 344
Caution, 9 Waste
Danger, 9 Check, 105, 213
Nota, 9 Connections, 24
Target, 9 Handling precautions, 41
Syringes Level detection problem, 390
Description, 458 Tank full, 389
Monthly maintenance, 346 Water
Plunger tips replacement, 346 Check, 105, 213
Problem, 378 Conductivity, 39
Replacement, 355 Connections, 24
Level detection problem, 390
T Requirement, 39
Temperature conditions, 17, 38 Resistivity, 39
Test Counter Tank empty, 389
Detailed test statistics check, 95 Weight, 39
Detailed test statistics interpretation, Westgard rules, 82, 326
97 WESTGARD_RULE_4-6, 442
Graph, 98 Work Balance, 124, 170
Overview, 92 Check, 127, 173
Test statistics check, 92 Reagent supply, 125, 171
Test statistics interpretation, 94 Sampling Exception, 126, 172
Test P1, 349 Worklist
Problem, 379 Calibration, 117
Test Review, 130, 180 Control, 120
Alarms check, 136, 186 New worklist, 209
Error Report, 133, 183 Patient, 158
Sampling Exception, 132, 182
Sequencing, 134, 184
Test Result, 130, 180
Test T1, 348
Problem, 379
TEST_RANGE_HIGH / LOW, 440
Throughput, 34
Time
Change, 313
User Manual 493

494 User Manual

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Clinical Chemistry Analyzer

Int. Ref. Doc.: RAB281EEN

4. Labels and Connections.................................................................................................... 23

3. Software Buttons Description......................................................................................... 50

4. Using the Software...............................................................................................................57

3. Quality Control by Test.......................................................................................................73

6. Test Counter (On Request)............................................................................................... 92

2. Workflow Overview............................................................................................................ 104

3. Start of Day........................................................................................................................... 105

4. Reagent Status.................................................................................................................... 111

5. Calibration and Control.................................................................................................... 114

6. Patient Samples.................................................................................................................. 158

7. Common Tasks in a Working Day................................................................................206

2. Calibration and Control Configuration.......................................................................232

3. Application Configuration............................................................................................... 252

4. System Configuration....................................................................................................... 301

Maintenance and Troubleshooting.......................................................................... 335

2. Sampling Alarms................................................................................................................. 420

3. Analytical and Quality Flags........................................................................................... 423

4. ISE Error Codes................................................................................................................... 448

Description and Technology......................................................................................... 451

2. Data Analysis........................................................................................................................ 466

User Manual iii

Reference Internal Reference Software Version Document Date Issued

Documentation instructions (USB flash drive)

1.2. What's New?

Here is the list of major updates in this document release:

Software Version 1.2.X

Item Description Chapter

User Manual Corrections and Additions

Item Description Chapter

2.1. Declaration of Conformity

2.2. Notice of Liability

Microsoft and Windows are registered trademarks of Microsoft Corporation.

2.5. Document Symbols

Gives a summary of what can be achieved if the task is performed.

2.6. Typographical Conventions

Indicates, from the main screen, the

Used for interface items (buttons,

Used for windows titles, dialog boxes

External links can be used to retrieve

Internal links can be used when

The Related information box provides

2.7. Copyright © 2016 by HORIBA ABX SAS

HORIBA ABX SAS

1. Warning and Precautions.................................................................................................. 12

4. Labels and Connections.................................................................................................... 23

1. Warning and Precautions

1.1. Limited Warranty

1.2. Safety Precautions

1.2.1. Electronic and Moving Parts

The following parts must not be handled or checked by the user:

1.2.2. Biological Hazard

All accessible surfaces of the instrument can be potentially contaminated by human

1.3. Graphics and Symbols

Switch off position Switch on position

Alternating current Manufacturer

This product conforms to the EC