Roche cobas 8000 / ISE Module User manual

cobas

®

8000 modular analyzer

series

Operator’s Manual – Version 5.3

Software Version 06-06

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

2

Publication information

Edition notice This publication is intended for operators of the

cobas

®

8000 modular analyzer series.

Publication

version

Software version Revision date Change description

1.0 01–01 2009-06 First version

2.0 02–01 2010-01 e 602 module added

3.0 03–01 2010-10 c 702 module added

4.0 04–01 2013-04 General update including, by way of example:

o New software features such as review of calibrator status,

PT link, rack unloading, change rack priority, reagent

cassette masking

o Revised software features such as download of

applications, calibrators, and QC material

o Hitergent was replaced by EcoTergent

4.0.1 04–01 2013-05 Manual cleaning revised

4.0.2 04–01 2013-06 Cleaning of pipetter probes revised

4.1 04–02 2013-11 o Changed ISE measuring ranges

o Use of different sample tubes on a rack

o Other changes and corrections

4.2 05–01 2014-10 New software features added

u What is new in publication version 4.2? (18)

5.0 06–02 2016-05 Publication redesigned according to the new Roche

documentation concept.

e 801 module added.

u What is new in publication version 5.0? (18)

5.1 06–03 2016-10 o Inclusion of information on the ISE support box

o Inclusion of the addendum "Cleaning rack trays"

o New section about fluorinated greenhouse gas

o Updated cobas link information

o Minor changes throughout the document

u What is new in publication version 5.1? (17)

5.2 06–05 2017-12 o Inclusion of the addendum "Sample foam detection"

o Inclusion of the addendum 1.0 to Operator’s Manual

version 5.1 (specifications of radio equipment)

o Minor changes throughout the document

u What is new in publication version 5.2? (17)

5.3 06–06 2018-12 o Inclusion of the addendum 1.0 to Operator's Manual

version 5.2 (instrument approvals)

o Inclusion of the addendum 1.0 to Safety Guide version 5.2

(cyber security)

o Inclusion of information on extended power off for 2-17

days procedure

o Minor changes throughout the document

u What is new in publication version 5.3? (16)

y Revision history

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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The cobas

®

8000 modular analyzer series is composed of

2 main components:

• The instrument includes the analytical modules, the

control unit, and other core components.

• The cobas

®

8000 data manager consists of a PC

which coordinates data in real time between the

instrument and the host.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product may need to update the publication information

as output of product surveillance activities, leading to a

new version of this publication.

Where to find information The Online Help contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• A software reference

• Configuration information

• Background information

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

instrument.

The Quick Reference Guide provides you with an

overview of pre-routine and routine tasks on the data

manager and instrument.

The Operator’s Manual focuses on routine operation

and maintenance. The chapters are organized according

to the normal operation workflow.

A separate Operator’s Manual is available for the

cobas

®

8000 data manager.

The PC manufacturer’s manual contains all information

about the control unit hardware.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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!

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the system and safety information before you

use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

described in this publication.

r Store all publications in a safe and easily retrievable

place.

Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Screenshots The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data, such as tests, results, or path names visible

therein must not be used for laboratory purposes.

Warranty Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Always leave software updates to a Roche Service

representative or perform such updates with their

assistance.

License information

cobas

®

8000 modular analyzer series software is

protected by contract law, copyright law, and

international treaties. cobas

®

8000 modular analyzer

series contains a user license between F. Hoffmann-La

Roche Ltd. and a license holder, and only authorized

users may access the software and use it. Unauthorized

use and distribution may result in civil and criminal

penalties.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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License agreement for UltraVNC software and

Linux Kernel

UltraVNC and Linux Kernel are pieces of free software for

all commercial uses, which are installed on the control

unit PC.

You can redistribute the software and/or modify it under

the terms of the GNU General Public License (version 2 or

later), as published by the Free Software Foundation. A

copy of the GNU General Public License (version 2) is

stored on the control unit PC. The path for the license is

C:\Program Files\uvnc bvba\UltraVNC.

The software is distributed without warranty. There is no

implied warranty of merchantability or fitness for a

particular purpose. For more information, see the GNU

General Public License at http://www.gnu.org/licenses.

The source code for the software is stored on the control

unit PC. The path for the source code is

C:\DriversAndTools\UltraVNC.

Open Source and Commercial Software

cobas

®

8000 modular analyzer series may include

components or modules of commercial or open-source

software. For further information on the intellectual

property and other warnings, as well as licenses

pertaining to the software programs included in

cobas

®

8000 modular analyzer series, refer to the

electronic distribution included with this product.

This open source and commercial software and

cobas

®

8000 modular analyzer series as a whole can

constitute a device regulated in accordance with

applicable law. For more detailed information, refer to the

user documentation and labeling.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to cobas

®

8000 modular

analyzer series.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS E, COBAS INTEGRA, and LIFE

NEEDS ANSWERS are trademarks of Roche.

All other trademarks are the property of their respective

owners.

Feedback Every effort has been made to ensure that this publication

fulfills the intended purpose. All feedback on any aspect

of this publication is welcome and is considered during

updates. Contact your Roche representative, should you

have any such feedback.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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Approvals

The cobas

®

8000 modular analyzer series meets the

requirements laid down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical

devices.

Directive 2014/53/EU of the European Parliament and of

the Council of 16 April 2014 on the harmonization of the

laws of the Member States relating to the making

available on the market of radio equipment and repealing

Directive 1999/5/EC.

To view the full text of the 2014/53/EU declaration of

conformity, go to the Roche DiaLog Global Web Site

(https://dialog1.roche.com/) and choose the eLabDoc

link.

If you are unable to access Roche DiaLog, contact a

Roche Service representative.

Directive 2011/65/EU of the European Parliament and of

the Council of 8 June 2011 on the restriction of the use of

certain hazardous substances in electrical and electronic

equipment.

Compliance is provided by means of the Declaration of

Conformity.

The following marks demonstrate compliance:

Instrument approvals Furthermore, the instrument is manufactured and tested

according to the following international safety standards:

• IEC 61010-1

• IEC 61010-2-101

The instrument complies with the emission and immunity

requirements described in standard IEC 61326-2-

6/EN 61326-2-6.

For in vitro diagnostic use.

Complies with the IVD directive 98/79/EC on in vitro

diagnostic medical devices

Issued by Intertek for Canada and the US.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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Contact addresses

Inside the European Union and

EFTA member states

Outside the European Union and

EFTA member states

Manufacturer of the

instrument

Hitachi High-Technologies

Corporation

1-24-14 Nishi-Shimbashi

Minato-ku Tokyo 105-8717

Japan

Manufacturer of

cobas

®

8000 data

manager

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Authorized

representative

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Manufactured by: Hitachi High-Technologies

Corporation

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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Table of contents 9

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

Table of contents

Publication information 2

Contact addresses 7

Table of contents 9

Intended use 13

Symbols and abbreviations 13

What is new in publication version 5.3? 16

What is new in publication version 5.2? 17

What is new in publication version 5.1? 17

What is new in publication version 5.0? 18

What is new in publication version 4.2? 18

Operation

1 Overview of the system

About the system 25

About the data manager 28

About the control unit 29

About the core components 31

About the cobas

®

ISE module 41

About the cobas c 701 module 54

About the cobas c 702 module 69

About the cobas c 502 module 88

About the cobas e 801 module 104

About the cobas e 602 module 125

2 Overview of operation

Overview of the user interface 145

Using the help system 159

Overview of cobas

®

link 165

3 Before operation

Quick reference: Main workflow 177

Starting the instrument 181

Troubleshooting system alarms 204

Preparing the instrument for operation 205

Measuring samples 219

4 Reagents

About reagent statuses 227

Working with reagent masking 230

Reagents of the ISE module 234

Reagents of the c 701 module 244

Reagents of the c 702 module 258

Reagents of the c 502 module 282

Reagents and consumables of the e 801

module 297

Reagents and consumables on the e 602

module 348

5 Calibration

Calibration 371

Calibrating tests on the ISE and cobas c

modules 390

Calibrating tests on the cobas e modules 394

6 Quality control

About quality control (QC) 405

About QC types 407

Performing routine QC 409

Performing QC for standby reagents 411

Performing timeout QC 413

Performing QC after calibration 415

Performing manual QC 417

Checking QC results 419

Deactivating tests for QC material 421

Assigning non-barcoded QC material to rack

positions 422

Unloading auto QC racks from the auto QC

compartment 424

7 Orders and results

About sample processing 429

About data distribution 430

About barcode and non-barcode mode 432

Switching between barcode and non-barcode

mode 434

About the Rack Reception mode 436

Ordering tests 437

Working with barcodes 446

Loading samples 449

Processing samples 459

Working with sample results 467

Processing rerun tests 481

Unloading samples manually 486

About the Calibration Review submenu 487

8 After operation

Performing manual finalization on cobas e

modules 493

Performing data backup and archiving 496

Preparing the instrument for powering off 508

Powering off the instrument 509

9 Special operation

Overview of masking functions 525

Operating with a pre-analytical system 528

Operating the instrument in backup operating

mode 531

10 Table of contents

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

Maintenance

10 Overview of maintenance

Maintenance definitions 541

About performing maintenance 543

About modes for maintenance 544

About maintenance pipes and maintenance

pipe functions 556

Checking maintenance due time 565

Checking maintenance status 566

Requesting the maintenance report 567

List of maintenance actions 570

List of maintenance checks 575

List of maintenance schedules for all

modules 579

List of cleaning solutions 582

List of spare parts and replacement

intervals 583

List of maintenance videos 585

11 Maintenance of the core unit and the MSBs

List of maintenance actions on the core unit and

the MSBs 589

Daily maintenance of the core unit and the

MSBs 590

Monthly maintenance of the core unit and the

MSBs 592

Maintenance as required on the core unit and

the MSBs 597

12 Maintenance of the ISE module

List of maintenance actions on the ISE

module 605

Daily maintenance of the ISE module 607

Weekly maintenance of the ISE module 616

Monthly maintenance of the ISE module 619

Every 2 months maintenance of the ISE

module 626

Quarterly maintenance of the ISE module 632

Every 6 months maintenance of the ISE

module 638

Maintenance as required on the ISE

module 642

13 Maintenance of the c 701 and c 702 modules

List of maintenance actions on the c 701 and

c 702 modules 661

Daily maintenance of the c 701 and c 702

modules 663

Weekly maintenance of the c 701 and c 702

modules 671

Monthly maintenance of the c 701 and c 702

modules 682

Quarterly maintenance of the c 701 and c 702

modules 699

Every 6 months maintenance of the c 701 and

c 702 modules 704

Maintenance as required on the c 701 and

c 702 modules 709

14 Maintenance of the c 502 module

List of maintenance actions on the c 502

module 737

Daily maintenance of the c 502 module 739

Weekly maintenance of the c 502 module 746

Monthly maintenance of the c 502 module 753

Quarterly maintenance of the c 502

module 771

Every 6 months maintenance of the c 502

module 775

Maintenance as required on the c 502

module 781

15 Maintenance of the e 801 module

List of maintenance actions on the e 801

module 789

Daily maintenance of the e 801 module 791

Every 2 weeks maintenance of the e 801

module 796

Maintenance as required on the e 801

module 818

16 Maintenance of the e 602 module

List of maintenance actions on the e 602

module 843

Daily maintenance of the e 602 module 844

Weekly maintenance of the e 602 module 848

Every 2 weeks maintenance of the e 602

module 864

Quarterly maintenance of the e 602

module 868

Maintenance as required on the e 602

module 874

Table of contents 11

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

Appendix

17 Specifications

General specifications 893

Specifications of the control unit 900

Specifications of the core components 901

Specifications of the ISE module 903

Specifications of the cobas c modules 905

Specifications of the cobas e modules 908

List of available accessories and

consumables 911

Specifications of barcodes 921

18 Glossary

Index 931

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Intended use

The cobas

®

8000 modular analyzer series is a fully

automated random-access software-controlled system

for immunoassays and photometric analysis intended for

qualitative and quantitative in vitro determinations using a

wide variety of tests.

The cobas

®

8000 modular analyzer series is an in vitro

diagnostic (IVD) medical equipment.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Symbols used in the publication

Product name Descriptor

cobas

®

8000 modular analyzer

series

System

cobas

®

8000 data manager

Data manager

cobas

®

ISE module

cobas c 702 module c 702 module

cobas c 701 module c 701 module

cobas c 502 module c 502 module

cobas e 801 module e 801 module

cobas e 602 module e 602 module

cobas c pack reagent cassette

cobas e pack reagent cassette

cobas e pack green reagent cassette

cobas e flow cobas e flow test

Self-Contained ISE Support Box ISE support box

Sample Cup standard cup

Micro-Sample Cup micro cup

Sarstedt micro tube cryo cup

AssayTip/AssayCup tray magazine

Wasteliner solid waste box

y Product names

Symbol Explanation

o List item

u Related topics containing further information

q

Tip. Extra information on correct use or useful

hints

r Start of a task

I Extra information within a task

y Symbols used in the publication

Roche Diagnostics

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Symbols used on products

Abbreviations The following abbreviations are used:

f Result of an action within a task

c Frequency of a task

n Duration of a task

d Materials that are required for a task

j Prerequisites of a task

u Topic. Used in cross-references to topics

p Task. Used in cross-references to tasks

w

Figure. Used in figure titles and cross-

references to figures

y

Table. Used in table titles and cross-references

to tables

z

Equation. Used in cross-references to

equations

Symbol Explanation

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number

Quantity contained in the package

Orientation of the package during

transportation

Complies with the directive 2011/65/EU on

RoHS

y Symbols used on products

Abbreviation Definition

ACN Application Code Number

ANSI American National Standards Institute

CleanCell (CC) Wash solution for measuring cells after

measurement

y Abbreviations

Roche Diagnostics

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CellCln1 Basic reaction cell wash solution

(NaOH-D)

CellCln2 Acid reaction cell wash solution

CFAS Calibrator for automated systems

(C.f.a.s.)

CSV Comma-separated values

CV Coefficient of variation

DIL ISE Diluent

EC European Community

ECL Electrochemiluminescence

ECO-D EcoTergent, additive to the incubation

bath to reduce surface tension

EFTA European Free Trade Association

EN European standard

ICVC Initial cassette volume check

IEC International Electrotechnical

Commission

IS ISE Internal Standard

ISE Ion-selective electrode

ISE COMP ISE Standard High, used as calibrator 3

ISE HIGH ISE Standard High, used as calibrator 2

ISE LOW ISE Standard Low, used as calibrator 1

IVD In vitro diagnostic

LED Light-emitting diode

LIS Laboratory information system

LLD Liquid level detection

MSB Module sample buffer

n/a Not applicable

NACL NaCl solution, used as diluent

NaOHD Wash solution for reagent probes and

reaction cells (D1)

ProCell (PC) Signal generating buffer for the ECL

detection

QC Quality control

RCM Reaction calculation mode

REF ISE Reference Electrolyte solution

RFID Radio-frequency identification

SCCS Additive to prevent reaction cell

carryover in long HbA1c batches (D3)

SD Standard deviation

SmpCln1 Basic sample probe wash solution

SmpCln2 Acid sample probe wash solution

SMS Wash solution for reagent probes and

reaction cells (D2)

Abbreviation Definition

y Abbreviations

Roche Diagnostics

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What is new in publication version 5.3?

This section provides an overview of all major changes in

this publication and the software.

Safety Guide The safety precaution Bubbles or foam inside a cobas

c pack has been renamed to Bubbles or foam inside a

reagent cassette.

The description about Data security has been revised.

Instrument approvals The following standards have been deleted from the

instrument approvals:

• IEC 61010-2-081 and A1

• UL 61010-1

• CAN/CSA C22.2 No. 61010-1

• CAN/CSA C22.2 No. 61010-2-101

• CAN/CSA C22.2 No. 61010-2-081

u Instrument approvals (6)

Extended Power off and on The description for extended power-on and power-off

has been reworked.

u Powering on cobas e modules after extended power-

off (190)

u Powering off the instrument (509)

Reagent loader e 801 The description and naming of the status indicator and

reset button has been reworked.

New function, expired ProCell II M bottles are masked

automatically, has been described.

STAT Short turn-around time

SysClean ISE Cleaning Solution/Elecsys SysClean

WEEE Waste Electrical and Electronic

Equipment

Abbreviation Definition

y Abbreviations

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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What is new in publication version 5.2?

This section provides an overview of all major changes in

this publication and the software.

Sample foam detection This document contains a revision/addition to the

following sections:

This revision was necessary due to the activation of the

sample foam detection with camera for the e 801 module.

u Specifications of the sampling system of cobas e

modules (909)

Specifications of radio equipment The c 701, c 702, and e 801 modules contain RFID

readers.

u Specifications of radio equipment (895)

What is new in publication version 5.1?

This section provides an overview of all major changes in

this publication and the software.

ISE support box The ISE support box is used in conjunction with the

ISE module and is available for the cobas

®

8000 modular

analyzer series without a c 702 module or c 701 module

in the configuration.

u The Self-Contained ISE Support Box (53)

Cleaning rack trays The cleaning procedure for rack trays has been added.

u Cleaning the rack tray (599)

Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the

hermetically sealed refrigeration.

u Fluorinated greenhouse gas (896)

Update of cobas

®

link information

Update of the cobas

®

link chapter.

u Overview of cobas

®

link (165)

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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What is new in publication version 5.0?

This section provides an overview of all major changes in

this publication and the software.

New layout and structure Resulting from customer feedback, we have updated the

layout and the structure of this publication to help you

find information easier and perform tasks quicker.

cobas e flow (e 801 module) cobas e flow is a feature of the data manager and the

e 801 module. cobas e flow tests are a pre-defined

combination of conventional immunology tests.

cobas e flow tests can be ordered from the data

manager and the host. They are managed via the data

manager. The involved immunology tests are performed

automatically on the e 801 module.

u About cobas e flow tests on the e 801 module (298)

Multi-application tests (e 801 module) Multi-application tests use the same reagent cassette,

but with different measurement protocols from different

applications.

Up to 4 applications can be part of 1 multi-application

test. The different applications have individual application

code numbers. Multi-application tests are pre-defined in

the application file.

Unlike cobas e flow tests, multi-application tests can be

ordered manually on the control unit or automatically by

the host.

u About multi-application tests on the e 801

module (305)

Quick Start Mode (e 801 module) When you enable the quick start mode, the instrument

can start a run in approximately 6:30 minutes instead of

about 12 minutes. Some steps, such as the reagent prime,

are only performed once when the instrument is powered

on, not during preparation for a run. You need

administrator access rights to enable the quick start

mode.

What is new in publication version 4.2?

This section provides an overview of all major changes in

this publication and software version 05-01.

This version requires Windows 7 on the control unit,

Windows XP is not supported.

Roche Diagnostics

cobas® 8000 modular analyzer series · Software Version 06-06 · Operator’s Manual · 5.3

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Mixing sample types and container types on a

rack

You can consolidate different sample types and container

types on a single rack. Sample consolidation can be

useful, for example, if the instrument is connected with a

CLAS. The CLAS can use the same rack range for pre-

processing of different samples types.

On the Standard tab of the Rack Assignment dialog

box, you must define a rack range for the sample type

None to consolidate samples. The information about the

sample type and in some cases also the information

about the container type is sent via HL7 protocol to the

control unit.

u About mixing different sample types on a rack (453)

Reagent registration by maintenance pipe You can include registration of reagents in a

maintenance pipe. Then new reagents are registered on

c 701/c 702 modules and the maintenance action

inventory update is performed on e 602 modules.

If you execute a maintenance pipe with this option, you

do not need to register new reagents manually. After

returning from manual cleaning mode, the required

reagent registration can be executed by a maintenance

pipe. If the reagent registration was already performed

before, it is skipped in the maintenance pipe.

u Creating a maintenance pipe (557)

Overwriting editable parameters when

updating an application

When you download an updated application from the

data manager, you can now choose between the

Overwrite option and the Partial Overwrite option:

• To download the application with all new settings,

choose the Overwrite option.

• To keep the settings of all editable application

settings, choose Partial Overwrite option.

In previous software versions, editable application

settings were not updated when you downloaded an

updated application from the data manager.

New ISE calibration scheme ISE Standard High is also used as compensator (S3).

u About calibration methods for ISE tests (374)

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Further changes and improvements • By limiting the number of racks on the instrument via

the new Rack Delivery dialog box, the turnaround

time of racks is improved.

• Integration of ISE data alarms: If an ISE.N or ISE.E data

alarm occurs, it is attached to all ISE test results for

this sample.

• For ISE calibrations, the software now uses separate

compensated limit checks for slope and calibrator S3

concentration.

• The user rights for downloading application settings,

calibrator data, QC material data, and special wash

data are reorganized.

u For links to the associated topics, refer to the Online

Help.

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