Roche cobas b 123 <4> User manual

cobas b 123 POC system

Instructions for Use

COBAS, COBAS B and LIFE NEEDS ANSWERS

are trademarks of Roche.

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

www.roche.com

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 3

cobas b 123 POC system

Publication information

Revision history

Edition notice This publication is intended for operators of the cobas b 123 POC system.

Every effort has been made to ensure that all information contained in this

publication is correct at the time of publishing. However, Roche may need to update

the publication information as output of product surveillance activities, leading to a

new version of this publication.

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 or your trainer

have received training from a Roche representative. 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.

War ranty 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.

Manual Version Software Version Revision date Changes

1.0 November 2009 not delivered

2.0 2.0 November 2010 Launch

2.1 April 2011 FDA submission draft

3.0 2.3 August 2011

4.0  2.4 December 2011

5.0  3.0 July 2012

6.0 4.0 December 2012 internal release - not launched

7.0  4.0 January 2013

8.0 4.1 July 2013

9.0  4.5 April 2014

10.0  4.7 February 2015

10.1  4.8 September 2016 Software update

11.0  4.13 October 2017 Software update

Table 1 Revision history

cobas b 123 POC system

Roche Diagnostics February 2018

4 Instructions for Use · Version 11.0

License information cobas b 123 POC system software is protected by contract, copyright law and

international treaties. cobas b 123 POC system 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.

Open Source and Commercial

Software

cobas b 123 POC system 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 the

cobas b 123 POC system, refer to the electronic distribution included with this

product.

This open source and commercial software and the cobas b 123 POC system as a

whole can constitute a device regulated in accordance with applicable law. For more

detailed information, refer to the Instructions for Use and labeling.

Please note that the respective authorization is no longer valid according to the

corresponding legislation should any unauthorized changes be made to the

cobas b 123 POC system.

Trademarks The following trademarks are acknowledged: COBAS, COBAS B, LIFE NEEDS

ANSWERS, AUTOQC, ROCHE MICROSAMPLER and COMBITROL 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 use. 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.

Approvals The cobas b 123 POC system 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 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.

This instrument complies with the emission and immunity requirements described

in this part of the IEC 61326 series.

Compliance is provided by means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU directives.

Issued by TÜV SÜD for Canada and the US.

Laboratory Equipment is the product identifier as shown on the

name plate.

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 5

cobas b 123 POC system

Contact addresses

Manufacturer

Edition

Version 11.0, February 2018

First edition: November 2009

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

www.roche.com

cobas b 123 POC system

Roche Diagnostics February 2018

6 Instructions for Use · Version 11.0

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 7

cobas b 123 POC system

Table of contents

Publication information 3

Contact addresses 5

Edition 5

Table of contents 7

Intended use 9

Intended user 9

Use environment 9

Symbols and abbreviations 9

What is new in publication version 11.0 14

Introduction and specifications

1 Safety information

Safety classifications 19

Safety precautions 20

Safety labels on the instrument and

consumables 27

2 General description

System information 31

System components 33

Consumable information 42

3 Specifications

Performance data 57

Sample throughput 81

Sample measurement time 82

Sample volumes 83

Sample types 84

Calibrations 85

Environmental parameters 86

Product data 88

Printer 90

User interface module 91

Barcode scanner 92

Imaging scanner (optional) 93

4 Theoretical foundations

Assigning unit formats to parameters 97

Selecting between pH and H

+

unit formats 98

Parameters and calculations 99

Calibration principle 115

Oximeter module (optional) 116

Reference and critical values 117

Assigning reference and critical ranges 120

Monitoring reference and critical ranges on

measurement reports 123

Assigning a correlation factor to a parameter 124

Operation

5 Installation and put out of operation

Installation 131

Installing the instrument 132

Put out of operation 134

6 Measurement

Preanalytics 139

Interferences 144

Limitations of clinical analysis 151

Configuring measurement input values 153

Configuring the measurement results screen 155

Configuring the parameter selection field 156

Performing a measurement 159

Measurement modes 167

Entering measurement input values 168

Measurement results and reports 171

Measuring database 173

Acid base maps 174

Patient trend diagrams 175

7 Quality control

General QC concept 179

Important information for evaluating QC

results 181

Performing QC measurements 182

QC results and reports 189

QC database 190

Levey-Jennings graphs 191

Performing a proficiency test measurement 192

Configuring the QC scheduler 197

Defining and configuring QC materials 201

Configuring QC rules and consequences 205

Configuring QC settings 207

Evaluating QC measurement results 209

Multirules 210

Removing QC consequences 213

QC troubleshooting 216

Troubleshooting AutoQC module blockages 217

8 Calibration

General information 221

Automatic calibrations 223

User-activated calibrations 226

Calibration database 227

Configuring calibration settings 228

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8 Instructions for Use · Version 11.0

cobas b 123 POC system

9 Calibration verification control

General information 233

Installing AutoCVC Packs 234

Performing an AutoCVC measurement 236

Managing CVC results in the QC database 238

Configuring analytical measurement ranges 239

10 Software functions

General software information 245

Overview tab 249

Description of the screen areas 250

Workplace tab 253

Instrument tab 254

Utilities tab 255

Instrument databases 256

Logging on and off 258

Connecting USB storage devices 259

Configuring system settings 260

Configuring network connection settings 267

Configuring operator settings 276

Changing security levels 280

Performing software and language updates 282

Exporting and importing configuration

settings 283

Audit trail 284

Available printout reports 286

Consumable change

11 Consumable change

Disinfection procedures 297

Disinfecting the instrument 298

Changing consumables 300

Additional information for consumable

changes 303

Troubleshooting

12 Troubleshooting

General information 309

Alarm area and buttons 310

System stops 312

Defects 316

Warnings 317

Information alarms 318

Status messages on the measurement report 319

Calibration and QC troubleshooting for

parameters 320

Performing Sensor Cartridge wetting

routines 322

Checking the Fluid Pack valve positions 323

Barcode scanner troubleshooting 324

Creating troubleshooting reports and log files 325

Depot repair 326

Appendix

13 Available accessories and consumables

Available accessories and consumables 331

14 Copyright information

Software license information 337

15 Glossary

Index

Index 345

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 9

cobas b 123 POC system

Intended use

The cobas b 123 POC system is a fully automated POC system for in vitro

measurement of pH, blood gases (BG), electrolytes (ISE), hematocrit (Hct),

metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O

2

Hb,

HHb, COHb, MetHb), oxygen saturation (SO

2

) and neonatal bilirubin (Bili).

In addition, the cobas b 123 POC system calculates derived parameters.

It is dedicated for use in a Point-of-Care environment and laboratory.

The integrated AutoQC module and the oximeter module are available as an option.

Intended user

Users of the instrument are trained professionals in the laboratory and trained

healthcare professionals in a point-of-care environment.

Use environment

The cobas b 123 POC system is intended to be operated in point-of-care settings and

hospital laboratories.

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the following product names

and abbreviations are used.

Symbols used in the publication

Product name Descriptor

cobas b 123 POC system system

cobas b 123 POC systems system

cobas b 123 Fluid Pack Fluid Pack

cobas b 123 Sensor Cartridge Sensor Cartridge

cobas b 123 AutoQC Pack AutoQC Pack

cobas b 123 AutoCVC Pack AutoCVC Pack

cobas b 123 Printer Paper printer paper

Table 2 Product names

Symbol Explanation

o List item

r Start of a task

Table 3 Symbols used in the publication

cobas b 123 POC system

Roche Diagnostics February 2018

10 Instructions for Use · Version 11.0

Symbols used on the instrument

Symbols used on consumables

s End of a task

u Related topics containing further information

q Tip. Extra information on correct use or useful hints.

Symbol Explanation

Table 3 Symbols used in the publication

Symbol Description

Catalog number

Serial number

Global Trade Item Number

Manufacturer

Date of manufacture

Direct current

Caution

Table 4 Symbols used on the instrument

Symbol Description

Catalog number

Batch code

Global Trade Item Number

Use by date

Table 5 Symbols used on consumables

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 11

cobas b 123 POC system

Temperature limitation

Do not use if package is damaged

Consumable contents

Control material

Fragile handle with care

Store upright

Do not reuse

Manufacturer

Sterilized using irradiation

Sterilized using ethylene oxide

Sufficient for <n> tests

Operator’s manual/operating instructions

Caution, consult accompanying documents

Handle with care

Symbol Description

Table 5 Symbols used on consumables

cobas b 123 POC system

Roche Diagnostics February 2018

12 Instructions for Use · Version 11.0

Abbreviations

Software symbol for the Fluid Pack

Software symbol for the AutoQC Pack

Software symbol for the Sensor Cartridge

Symbol Description

Table 5 Symbols used on consumables

Abbreviation Definition

1P 1-point calibration

2P 2-point calibration

AMR Analytical measurement range

A

rate

Assisted breathing rate

ASTM American Society for Testing and Material

AutoQC Automatic Quality Control

BG Blood gas

Bili Bilirubin

BSA Bovine serum albumin

Ca

2+

Ionized calcium

CCD Charge coupled device

CE Conformité Européenne

CF Compact flash

CLIA Clinical Laboratory Improvement Amendments

CLSI Clinical and Laboratory Standards Institute

COHb Carboxyhemoglobin

COOX Co-oximetry

CPAP Continuous positive airway pressure

CSV Comma-separated values

CVC Calibration verification control

DHCP Dynamic host configuration protocol

DIN German national organization for standardization

DNS Domain name server

e.g. for example

EC European community

EN European standard

EQA External Quality Assurance

Glu Glucose

H

+

Hydrogen ion concentration

Hb Hemoglobin

Hct Hematocrit

HHb Deoxyhemoglobin

Table 6 Abbreviations

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 13

cobas b 123 POC system

i.e. that is to say

IEC International Electrotechnical Commission

ISE Ion-selective electrode

ISO International Organization for Standardization

IT Information technology

IVD In vitro diagnostic

K

+

Potassium

Lac Lactate

LCD Liquid crystal display

LED Light-emitting diode

LIS Laboratory Information System

MAP Mean airway pressure

MCHC Mean corpuscular hemoglobin concentration

MCT Medium chain triglycerides

MetHb Methemoglobin

mm millimeter

MSDS Material safety data sheet

MV Mean value

Na

+

Sodium

NIST National Institute of Standards and Technology

O

2

Hb Oxyhemoglobin

PCO

2

Partial pressure of carbon dioxide

PEEP Positive end-expiratory pressure

PIP Peak inspiratory pressure

PO

2

Partial pressure of oxygen

POC Point-of-care

POCT1-A Connectivity standard for point of care devices

QC Quality control

RAM Random access memory

RECAL Recalibration

RQ Respiratory quotient

SD Standard deviation

SIM Sample input module

SO

2

Oxygen saturation

S

rate

Spontaneous breathing rate

STDBY Standby

Te Expiratory time

tHb Total hemoglobin

Ti Inspiratory time

UIM User interface module

USB Universal Serial Bus

VT Tidal volume

Abbreviation Definition

Table 6 Abbreviations

cobas b 123 POC system

Roche Diagnostics February 2018

14 Instructions for Use · Version 11.0

What is new in publication version 11.0

“What is new in publication

version” section

This section describes new content that is found in this version of the Instructions for

Use.

Editorial changes Considerable editorial changes have been made to the Instructions for Use to make it

easier for you to find content and perform your tasks on the

cobas b 123 POC system.

New plausibility check to perform

neonatal bilirubin measurements

A new plausibility check feature has been added to the software to identify erroneous

bilirubin results.

u Plausibility check for neonatal bilirubin measurements (p. 151)

New barcode scanner The Datalogic Touch 90 barcode scanner replaces the Unitech MS 180 barcode

scanner. Datalogic Touch 90 barcode scanners include a wider scanner area to help

scan longer barcodes on consumable material sheets.

u Barcode scanner (p. 39)

u Barcode scanner troubleshooting (p. 324)

New consumable information Plastic capillary tubes (material 05174791001) and sterile capillary holders (material

05174830001) have been discontinued.

u Available accessories and consumables (p. 329)

Revised reference ranges for

glucose and lactate

u Reference and critical values (p. 117)

Status message information on

measurement reports

Status messages appear on measurement reports to provide you additional

information about your measurement result, or to explain why a measurement result

could not be determined.

A list of these messages is now found in this version of the Instructions for Use.

u Status messages on the measurement report (p. 319)

New approvals section Compliance of all applicable directives and guidelines for the

cobas b 123 POC system can now be found in the approvals section at the front of the

Instructions for Use.

u Approvals (p. 4)

February 2018

Introduction and specifications

1 Safety information ........................................................................................................................... 17

2 General description.......................................................................................................................... 29

3 Specifications.................................................................................................................................... 53

4 Theoretical foundations ................................................................................................................... 95

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 17

cobas b 123 POC system 1 Safety information

Table of contents

Safety information 1

The chapter provides information about the safe operation of the system.

In this chapter

Chapter

1

Safety classifications.............................................................................................................19

Safety precautions.................................................................................................................20

Operator qualification...................................................................................................20

Installation and deinstallation......................................................................................20

Operating conditions.....................................................................................................21

Safe and proper use of the system................................................................................21

Electrical safety...............................................................................................................21

Biohazardous materials .................................................................................................22

Mechanical safety...........................................................................................................23

Consumables...................................................................................................................23

Reagents and working solutions...................................................................................24

Incorrect results..............................................................................................................24

Software and data security............................................................................................25

Instrument damage........................................................................................................26

Safety labels on the instrument and consumables ...........................................................27

Roche Diagnostics February 2018

18 Instructions for Use · Version 11.0

1 Safety information cobas b 123 POC system

Table of contents

Roche Diagnostics February 2018

Instructions for Use · Version 11.0 19

cobas b 123 POC system 1 Safety information

Safety classifications

This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the ANSI

Z535.6 Standard. Familiarize yourself with the following meanings and icons:

Safety alert

The safety alert symbol is used to alert you to potential physical injury hazards. Obey all

safety messages that follow this symbol to avoid possible damage to the system, injury, or

death.

These symbols and signal words are used for specific hazards:

WARNING

r ... indicates a hazardous situation that, if not avoided, could result in death or serious

injury.

CAUTION

r ... indicates a hazardous situation that, if not avoided, could result in minor or moderate

injury.

NOTICE

r ... indicates a hazardous situation that, if not avoided, may result in damage to the

instrument.

Protective gloves and goggles, suitable protective clothing, and if necessary, mouth

protection has to be worn.

Important information that is not safety relevant is indicated with the following

symbol:

q

Tip

... indicates additional information on correct use or useful tips.

Roche Diagnostics February 2018

20 Instructions for Use · Version 11.0

1 Safety information cobas b 123 POC system

Safety precautions

To avoid serious or fatal injury, read and comply with the following safety

precautions.

Operator qualification

Insufficient knowledge and skills As an operator, ensure that you know the relevant safety precaution guidelines and

standards and the information and procedures contained in these instructions.

o Do not carry out operation and maintenance unless a Roche representative has

trained you or your trainer to do so.

o Leave maintenance, installation, or service that is not described to trained Roche

Service representatives.

o Carefully follow the procedures specified in the instructions for operation and

maintenance.

o Follow standard laboratory practices, especially when you work with

biohazardous material.

Installation and deinstallation

Transport Risk of personal injury when lifting. The cobas b 123 POC system, without

consumables in the bottle compartment and AutoQC materials in the AutoQC

module, weighs approximately 18 kg.

o Perform the put out of operation procedure before moving the system.

u Put out of operation (p. 134)

o Do not attempt to relocate or transport the system without the assistance of

another individual.

o Do not attempt to lift the system with a Fluid Pack and AutoQC Pack in the

system. In addition, make sure that before lifting, there are no other objects

attached to the system.

o Lift the system only from its designated holding points.

u Holding points (p. 89)

Errors in installation Only trained Roche Service representatives may install the system.

o Leave installation that is not described to trained Roche Service representatives.

Disposal A biohazardous system may lead to infection.

o Treat the system as biohazardous waste. Decontamination (the combination of

processes including cleaning, disinfection, and/or sterilization) is required before

reuse, recycling, or disposal of the system.

o Dispose of the system according to the local regulations. For more information,

contact your Roche service representative.

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