Instructions for Use Cobas b121 en[1]

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cobas b 121 systemInstructions for Use


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COBAS, COBAS B and LIFE NEEDS ANSWERS

are trademarks of Roche.

©2008 Roche Diagnostics

Roche Diagnostics GmbH

D-68298 Mannheim

Germany

www.roche-diagnostics.com


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Roche Diagnostics June 2008

Instructions for Use · Version 10.0 1

cobas b 121 system

Revision History

Edition notice

cobas b 121 system

In the course of 2005 the Roche OMNI C system was rebranded under the RocheDiagnostics professional IVD user brand cobas®.

Systems with a serial number of 5000 or above are cobas b 121 system.

Systems with a serial number up to 4999 are Roche OMNI C systems.

Copyright

© 2008, Roche Diagnostics GmbH. All rights reserved

The contents of this document may not be reproduced in any form or communicatedto any third party without the prior written consent of Roche Diagnostics.While every effort is made to ensure its correctness. Roche Diagnostics assumes noresponsibility for errors or omissions which may appear in this document.Subject to change without notice.

Brands

COBAS, COBAS B, COBAS BGE LINK, LIFE NEEDS ANSWERS, ROCHE OMNI,AUTOQC, ROCHE MICROSAMPLER, COMBITROL and AUTO-TROL aretrademarks of Roche.

Manual Version Software Version Revision date Changes

2.0 October 2001

3.0 1.2 January 2002

4.0 1.31 December 2002

5.0 1.60 December 2004

6.0 1.70 May 2005 English only!

7.0 1.71 Juni 2006 cobas branding

8.0 1.71 Juni 2006

9.0 1.72 May 2007

10.0 1.74 June 2008 Change of the template


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cobas b 121 system


2 Instructions for Use · Version 10.0

Contact addresses

Manufacturer

Edition

Revision 10.0, June 2008

First edition: October 2001

REF/No. 03260992001

Roche Diagnostics GmbH

D-68298 Mannheim / Germany

www.roche.com


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cobas b 121 system

Table of contents

Revision History 1

Edition notice 1Copyright 1Brands 1Contact addresses 2Edition 2Table of contents 3Preface 5How to use this manual 5Where to find information 5Conventions used in this manual 5

Introduction and specifications Part A

1 Safety information

Important information A-5Operating safety information A-6

2 General description

Introduction A-9General notes A-10Measurement and calibration procedure A-12Safety instructions for specific dangers A-13System description A-15

3 Installation and shutdown

Installation A-21Shutdown A-36

4 Specifications

Performance data A-47Default and input values A-49Sample throughput A-49Sample volume A-49Sample types A-50Calibrations A-50Environmental parameters A-51

Product data A-53Printer A-53Screen A-54Barcode scanner A-54

Operation Part B

5 Measurement

Preanalytics B-5Measuring procedure B-8

6 Quality control

Quality control - general B-17General QC concept B-17

Important information concerning the analysis

of QC measurement results B-19Material setup B-20QC measurement B-26Multirules B-28QC consequences B-30QC unlock B-31QC troubleshooting B-32

7 Calibration

Calibration - general B-37

8 Operating modes

Operating modes - general B-43User interface B-43Analyzer mode B-49Software overview B-61

Maintenance Part C

9 Maintenance

Maintenance - general C-5Decontamination C-5Daily C-7Weekly C-8

Semi annual C-9Sample-dependent maintenance procedures C-10Unscheduled C-17Additional maintenance procedures C-30Maintenance overview C-31Maintenance scheduler C-32

Troubleshooting Part D

10 Troubleshooting

Troubleshooting - general D-5

System stops D-5List of system stops D-7Electrode status D-14

Appendix Part E

11 List of consumables

Order information E-5

Index Part F

Index F-3


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cobas b 121 system


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cobas b 121 system

Preface

This manual has detailed descriptions of cobas b 121 system features and general

operational concepts, specification functions and use of controls, operatingtechniques, emergency procedures, product labeling and maintenance procedures.

How to use this manual

To help you find information quickly, there is a table of contents at the beginning ofthe book and each chapter. In addition, a complete index can be found at the end.

Where to find information

In addition to the Instructions for Use, the following documents are also provided toassist in finding desired information quickly:

o cobas b 121 system Reference Manual

o cobas b 121 system Short Instruction

Conventions used in this manual

Visual cues are used to help locate and interpret information in this manual quickly.This section explains formatting conventions used in this manual.

Symbols Helping to locate and interpret information in this manual the following symbols areused:

Keep this manual in a safe place to ensure that it is not damaged and remains available for

use.

This Instructions for Use should be easily accessible at all times.

Symbol Description

a Procedural step

o List item

e Cross-reference

h Call up of screen

Note


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cobas b 121 system



IVD symbols The IVD symbols are used in accordance with DIN EN 980:2003, ISO 15223:2000 (asper the In Vitro Diagnostics Directive 98/79/EC), and DIN EN ISO 780:1997.

Attention, Warning, Danger

All sections / passages that are marked with this symbol describe

procedures and/or indicate conditions or dangers that could damage

or lead to a malfunction in the cobas b 121 system, and which

therefore should never be attempted and/or must be observed to

avoid potential injuries (to patients, users and third parties).

Risk of infection!

All sections and parts of texts that are marked with this symbol

describe procedures that may involve risk of infection.

Symbol Description

Symbol Description

This product complies with the requirements in the guideline for In

Vitro Diagnostic 98/79/EC.

Lot designation

Consumables: use by,.. (expiry date)

The consumables must be completely consumed by the indicated

date.

If a day is not indicated, apply the last day of the respective month.

Store at ,..The conditions necessary to preserve the product's shelf life before

opening.

For in vitro diagnostic use

"Grüner Punkt" (in Germany)

Manufacturer — according to In Vitro Diagnostic guidelines 98/79/

EG

Store upright

Risk of infection!

(according to the standard DIN EN 61010-2-101:2002) (Instrument)

Risk of infection!

(according to the standard DIN ISO 15223-1:2005)(Consumables)

Catalogue number


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cobas b 121 system

Other symbols The following symbols are listed as additional information:

Caution (refer to accompanying documents). Please refer to safety-

related notes in the manual, accompanying this instrument.

Please consult instructions for use

Serial number (model plate)

Symbol Description

Symbol Description

Electrodes:This date indicates the limit of the maximum storage time of

an electrode. The electrode must be installed in the instrument

no later than the imprinted date.

If the installation takes place on the imprinted date, it still falls

within the specifications. The calculation of the “Install

before” date is based on the production date of the elctrode.

Danger symbol: "Irritant" (on the label and the packaging of

C3 Fluid Pack)

Rating: Although not corrosive, momentary, longer-lasting, or

repeated contact with skin or mucous membrane may result in

inflammation. Danger of sensitization during contact with

skin (when classified with R 43).

Caution: Avoid contact with eyes and skin, do not inhale

vapors.

Do not use content if the packaging is damaged

Protective gloves, protective goggles and suitable protective

clothing must be worn.


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cobas b 121 system



Abbreviations The following abbreviations are used:

Abbreviation Definition

A

ANSI American National Standards Institute

AQC Automatic Quality Control

B

BG Blood gas

C

CLIA Clinical Laboratory Improvement Amendments

CLSI Clinical and Laboratory Standards Institute

cond Conductivity

CSA Canadian Standards Association

C1 Calibration Solution 1

C2 Calibration Solution 2

C3 Fluid Pack

D

dBA Decibel weighted against the A-frequency response curve. This curve

approximates the audible range of the human ear.

DIL Diluent

DNS Domain Name Server

E

EC European community

e.g. exempli gratia – for example

EN European standard

F

FMS Fluid mixing system

H

Hct Hematrocrit

HIV Human immunodeficiency virus

HW Hardware

I

i.e. id est – that is to say

ISE Ion selective electrode

IVD In vitro Diagnostic Directive

L

LCD Liquid cristal display

LIS Laboratory Information System

LJ Levey Jennings

M

MAC Media Access Control

MC Measuring chamber

MCon Measuring contact

MSDS Material safety data sheet

MSS Metabolite sensitive sensor

MV Mean value


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cobas b 121 system

e For writing the measuring, calculated and input values see Chapter 8 Operating modes >

Parameter on page B-73!

P

PP Peristaltic pump

Q

QC Quality control

R

REF Reference solution

S

SIP Sample inlet path

SD Standard deviation

SDC Sample distributor cartridge

SO2 Oxygen saturation

T

tHb Total hemoglobinU

UL Underwriters Laboratories Inc.

V

VDE Association of German Electrical Engineers (Verband Deutscher

Elektrotechniker)

Abbreviation Definition

http://../cobas%20b%20221%20System/Operator%20Manual/Book%20DE/Softwaremodi.pdfhttp://../cobas%20b%20221%20System/Operator%20Manual/Book%20DE/Softwaremodi.pdfhttp://../cobas%20b%20221%20System/Operator%20Manual/Book%20DE/Softwaremodi.pdf


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cobas b 121 system




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June 2008

1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

3 Installation and shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-19

4 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-45

Introduction and specifications A


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Instructions for Use · Version 10.0 A-3

cobas b 121 system 1 Safety information

Table of contents

Safety information

The information provided in this chapter is essential for the safe, trouble-free

operation of the instrument and must be read and understood by the user.

Important information ...............................................................................................A-5

Operating safety information .....................................................................................A-6

In this chapter Chapter 1


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A-4 Instructions for Use · Version 10.0

1 Safety information cobas b 121 system

Table of contents


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cobas b 121 system 1 Safety information

Important information

Important information

These Instructions for Use contain vital warnings and safety information.

This instrument is intended to be used only for the specialized purpose described in

the instructions. The most important prerequisites for use, operation, and safety areexplained to ensure smooth operation. No warranty or liability claims will be coveredif the machine is used in ways other than those described or if the necessaryprerequisites and safety measures are not observed.

The instrument may be operated only by persons whose qualifications enable them tocomply with the safety measures that are necessary during operation of theinstrument.

Suitable protective equipment, like laboratory clothing, protective gloves, protectivegoggles and if necessary mouth protectors, must be worn to prevent direct contactwith biological working materials. In addition, a face mask is required if there is a

risk.

Adjustments and maintenance performed with covers removed and power connectedmay be attempted only by a qualified technician who is aware of the associateddangers.

Instrument repairs are to be performed only by the manufacturer or qualified servicepersonnel.

Only accessories and supplies either delivered by or approved by Roche are to be usedwith the instrument. These items are manufactured especially for use with thisinstrument and meet the highest quality requirements.

Operation of the instrument with solutions whose composition is not consistent with

that of the original solutions can negatively affect the long-term measurementaccuracy. Deviations in the composition of the solutions can also decrease the servicelife of the electrodes.

For safety reasons, quality control measurements must be performed daily. Since themeasurements of the instrument depend not only on the correct characteristicfunction, but also on a series of marginal conditions (e.g. pre-analysis), resultsobtained from the instrument should be submitted for an expert opinion beforetaking additional measures based on the supplied measurements.

WARNING

Caution (refer to accompanying documents)!

Please refer to safety-related notes in the manual accompanying this instrument.


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1 Safety information cobas b 121 system

Operating safety information

Operating safety information

The instrument has been constructed and tested according to the following European

Standards:

o IEC/EN 61010-1:2001

o IEC/EN 61010-2-101:2002

o IEC/EN 61010-2-081:2002 + A1:2003

It was delivered from the factory in flawless condition with regards to safety features.In order to preserve this condition and ensure safe operation, the user must respectthe notices and warnings that are contained in these Instructions for Use.

o This instrument is classified under the protection class I according toIEC/EN 61010-1.

o The instrument meets the conditions for overvoltage category II.

o The instrument meets the conditions for contamination level 2.o Do not operate the instrument in an explosive environment or in the vicinity of

explosive anesthetic mixtures containing oxygen or nitrous oxide.

o If objects or liquids enter the internal areas of the instrument, remove theinstrument from its power supply and allow an expert to check it thoroughlybefore using it again.

o The instrument is suitable for long-term operation indoors.

WARNING

o The power cord must be plugged into a grounded power receptacle. When using an

extension cord, make sure it is properly grounded.

o Any rupture of the ground lead inside or outside the instrument or a loose ground

connection may result in hazardous operating conditions for the operating personnel.Intentional disconnection of the grounding is not permitted.

o The instrument is not suitable for operation with a direct current power supply.

o Use only the original power plug delivered with the cobas b 121 system.


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cobas b 121 system 2 General description

Table of contents

General description

This chapter contains a general description of the instrument, as well as

precautionary measures against special dangers and the proper handling of sensorsand solutions.

Introduction ................................................................................................................A-9

General notes .............................................................................................................A-10

Application area ...................................................................................................A-10

Operating instructions ........................................................................................A-10Important buttons on the screen ........................................................................A-10

Measurement and calibration procedure .................................................................A-12

Measurement procedure .....................................................................................A-12

Calibration procedure .........................................................................................A-12

Measurement evaluation .....................................................................................A-12

Safety instructions for specific dangers ....................................................................A-13

Handling samples ................................................................................................A-13

Disposal of waste water, bottles, electrodes, and the instrument ..................... A-13

Decontamination ................................................................................................A-13

Handling solutions ..............................................................................................A-13

Handling electrodes ............................................................................................A-14System description ....................................................................................................A-15

Visual identification ............................................................................................A-15

Screen ...................................................................................................................A-15

Printer ..................................................................................................................A-15

Measurement chamber ........................................................................................A-16

Pump ....................................................................................................................A-16

Flap .......................................................................................................................A-16

Bottle compartment ............................................................................................A-16

Power supply ........................................................................................................A-16

Position of the power switch .........................................................................A-16

Reverse side ..........................................................................................................A-17Interface .........................................................................................................A-17



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2 General description cobas b 121 system

Table of contents

Barcode scanner .............................................................................................A-18

Warning and identification labels .................................................................A-18


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Introduction

Introduction

The cobas b 121 system is a modular analyzer for measuring blood gases, electrolytes,total hemoglobin, oxygen saturation and hematocrit in whole blood, serum, plasma,acetate and bicarbonate containing dialysis solutions, and QC materials.

It is possible to complete database procedures or to make simultaneous adjustmentsduring measurement or calibration.

The individual, mutually independent operating modes are defined as follows:

o Analyzer: measuring, QC, system, calibration, commonly used functions

o Database: data about patients, measurement, calibration, QC, and the instrument

o Setup: instrument settings

o Info: Roche info, version number, fill levels, help, sensor report

The instrument is currently available in the following configuration:

o BG (pH, P O2, P CO2) / ISE (Na+, K+, Cl–, Ca2+) and tHb/SO2

A new fluid calibration system eliminates the need for expensive calibration gases.This change results in easier handling, a smaller footprint, and reduced costs.

An easily understood "Touch Screen" interface facilitates easy operation and savescostly and time-consuming user training.

The patented electrodes are completely maintenance-free, and only require a verysmall sample volume.

Figure A-1


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General notes

General notes

Application area

The instrument is designed to measure BG / ISE / tHb/SO2 in whole blood. Theaccuracy of measurement values is checked accordingly.

In order to achieve accurate measurements of recommended aqueous controlsolutions (with regards to deviations from biological samples), choose the propercomponents and make the corresponding corrections in the QC measurement mode.

The accuracy of measurement values of undefined aqueous solutions cannot beguaranteed (e.g. due to the possibility of interfering components and/or missing orinsufficient buffer systems, and/or differences in ionic strength and diffusionpotential when compared to biological samples).

Operating instructions

The instrument should be powered on at all times!

If the instrument will remain turned off for longer than 24 hours, it is necessary tocarry out shutdown procedures.

e For more information, see Chapter 3 Installation and shutdown!

Prevent fluids leaking inside the analyzer.

In order to ensure the quality of the measurement results, complete a quality control

test on 3 levels (low, normal, high) after each electrode exchange, after each exchangeof solutions and packs and after startup of the instrument.

Additionally complete a quality control test on one level between two automatic2P calibrations. The levels have to be alternated (low, normal, high).

e For more information, see Chapter 6 Quality control !

Important buttons on the screen

Buttons Description

Operating mode "Analyzer"

Operating mode "Database"

Operating mode "Setup"

Button "Info"

More functions


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General notes

e For more information, see Chapter 8 Operating modes, section Buttons on page B-47!

Confirm

Cancel

Activate / deactivate

Start action

Buttons Description


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Measurement and calibration procedure

Measurement and calibration procedure

Measurement procedure

Use the following methods are used to determine the various measurement variables:

P O2 : Use of the Clark measurement principle: measurement of current generated bythe reduction of oxygen

P CO2 : Use of the Severinghouse principle: potentiometric measurement of the pHchange in the electrode caused by CO2.

pH, Na+, K+, Ca2+ and Cl– are potentiometric electrodes. Special glasses are used asthe sensitive element for pH and Na+. The potassium and calcium membranescontain special neutral carriers. A special ion exchanger is used for chloridemembranes. Calculation of these variables also requires the use of a reference

electrode - a permanently contacted chloride electrode in the instrument.

tHb /SO2 : Light absorption in whole blood is measured at four different wavelengths,whereby on one hand the sample is subjected to light radiation and on the other handthe dispersed light is also evaluated.

Hematocrit : Measurement of the sample's conductivity

Calibration procedure

tHb and SO2 are factory calibrated. Ambient air and a zero point solution are used tocalibrate oxygen. The remaining parameters are calibrated using two solutions, which

are mixed in various ratios. Gas containers are not used. The use of at least twocalibration points for each measurement variable and constant internal monitoring ofthe calibrations ensures the accuracy and precision of the measurement values.

Measurement evaluation

The results from the instrument must be carefully examined by a clinical-medicalspecialist who will take the patient's clinical condition into consideration before anyclinical decisions are reached based on the test results.

In order to ensure the quality of the measurement results, complete a quality control

test on 3 levels (low, normal, high) after each electrode exchange, after each exchangeof solutions and packs and after startup of the instrument.

Additionally complete a quality control test on one level between two automatic2P calibrations. The levels have to be alternated (low, normal, high).

e For more information, see Chapter 6 Quality control !


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Safety instructions for specific dangers


Handling samples

Respect the necessary hygienic regulations when handling samples because samplesmay contain dangerous viruses.

e For more detailed information, see Chapter 5 Measurement !

Disposal of waste water, bottles, electrodes, and the instrument

Decontamination

The purpose of this procedure is to minimize risk when handling items that were incontact with biological samples.

Roche recommends following a decontamination procedure in addition toregulations specific to the laboratory.

These decontamination procedures should be performed periodically to minimize therisk of infections (incl. hepatitis virus and HIV).

e For more detailed information about decontamination, see Chapter 9 Maintenance!

Handling solutions

Store the instrument solutions according to the specified packaging requirements.The solutions should be adapted to the ambient temperature before use.

The shelf life of the solutions is limited.

Please read the bottle label and the packaging for the correct storage temperature andthe maximum shelf life.

Dispose waste water, bottles, electrodes and the instrument according to local and/or

labour regulations (biologically contaminated—hazardous waste!)

Always wear gloves!

ATTENTION

CAUTION! DO NOT FREEZE!

If frozen, the solution's concentration may change and cause calibration errors!

Do not use damaged C3 Fluid Packs! Do not mix the individual components!


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Handling electrodes

Store the electrodes according to the packaging specifications.

The shelf life of the electrodes is limited.

See the electrode label and the packaging for the correct storage temperature and themaximum shelf life.

NOTE IMPORTANT! Installation note for theP CO2 electrode

Insert the electrode into the measuring chamber within 5 minutes of opening the ALU-PE

packaging.

A special protective gas atmosphere designed to condition the P CO2 electrode during

storage is found inside the ALU-PE packaging.

This gas atmosphere ensures immediate potential stability during insertion of the electrode

into the measurement chamber and/or immediate readiness for measuring after the

2P calibration is completed.

If more than 5 minutes elapse after opening the ALU-PE packaging, the level of gas

conditioning could be lost and the time required for the first-time calibration could be

increased.


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System description

System description

Visual identification

Screen

All information (results, error messages, warnings, etc.) is displayed on the screen.The screen consists of a 5.7" colour LCD that is covered with a touch-sensitive film("touch screen").

Printer

The low-noise 2" thermal printer with integrated paper cutter for roll paper is locatedunderneath the printer cover.

A Printer cover

B Pump

C Power pack / main switch

D Unlocking knob for the AutoQC module

E Bottle compartment

F Measurement chamber with the electrodes

and tHb/S O2 module

G Flap

H Contrast setting

I Screen

Figure A-2

A

C

B

D

E

I

F

H

G


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System description

Measurement chamber

The measurement chamber with the electrodes and the tHb/SO2 module are locatedbeneath the instrument cover.

The electrodes are flow-through electrodes with a visible sample channel.

The tHb/SO2-module is an optical sensor module for determining the levels of totalhemoglobin (tHb) and oxygen saturation (SO2) in whole blood.

Pump

A peristaltic pump transports the sample and the operating fluids inside theinstrument.

Flap

When opening the flap, notice two definitive locking positions:

o Flap position 1 (half opened) – Syringe mode—for syringes and ampoules

o Flap position 2 (completely opened) – Capillary mode—for capillaries andRoche MICROSAMPLERs

Bottle compartment

The calibration solutions and the waste container are located behind the bottle

compartment cover.

Power supply

This unit contains the power switch and the power connector.

Position of the power switch

Power switch "OFF" Power switch "ON"

Figure A-3


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System description

Reverse side

Interface

Only data processing units manufactured according to the standards IEC 950(UL1950) may be attached to the interface connections!

COM 1 This interface can be assigned to a ticket printer and Host FMT.

e For an exact description of the assignment, see Reference Manual chapter Setup, section

Interfaces > COM 1.

COM 2 This interface can be assigned as serial interface to ASTM.

e For an exact description of the assignment, see Reference Manual chapter Setup, section

Interfaces > COM 2.

A COM 1

B COM 2

C Barcode Scanner

D Network connection

Figure A-4

COM 1* RS 232 Schnittstelle

COM 2* RS 232 Schnittstelle

Barcode PS/2 DIN - 6p Buchse

Network 10BaseT Ethernet (RJ45)

A B C D

*TIP:

Always use a filter adapter when using the serial interface. Order this part from your

customer service representative!


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System description

Barcode scanner

o Scanning of solution data (type, lot number, expiration date current composition,etc.)

o Scanning of electrode data (type, lot number, expiration date)

o Scanning of patient or user identity

o Scanning of QC data (QC material, lot number, basis, expiration date,target values, etc.)

o Scanning of desired alphanumeric code

e For further information, see the enclosed manual for the PS2 hand-held scanner (included

in scope of delivery).

Warning and identification labels

Figure A-5

ATTENTION

Press the button on the underside to activate the scanner! A beeping sound and a brief

illumination of the LED on the upper side indicate the successful scanning of the barcode.

Figure A-6 Identification label

A Identification label

Figure A-7

A


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cobas b 121 system 3 Installation and shutdown

Table of contents

Installation and shutdown

In this chapter, the software-guided installation and shutdown of the instrument are

described step by step. The sequence of the steps described must be strictly followed.

Installation .................................................................................................................A-21

Location ...............................................................................................................A-21

Accessories ...........................................................................................................A-22

Installation ...........................................................................................................A-22

1. Attach power cord and barcode scanner ..................................................A-22

2. Installing the AutoQC module (Automatic Quality Control Module) ..A-23

3. Switch on ....................................................................................................A-25

4. Select language ...........................................................................................A-25

5. Setting the date and time ............................ ............................. ................. A-25

6. Check/Activate the parameters tHb and SO2 ...........................................A-25

7. Checking the barometer value ..................................................................A-26

8. Checking the AutoQC module .............................. ................................. .. A-26

9. Installation .................................................................................................A-26

10. Check tubes at V2 and V9 .......................................................................A-26

11. Insert FMS tubes (Fluid Mixing System) ........................... .................... A-27

12. AutoQC module (option) .......................................................................A-27

13. Attach pump tube ....................................................................................A-28

14. Insert needle and fill port holder ............................................................A-28

15. Insertion of printer paper ............................. .............................. ............ A-29

16. Insertion of bottles .............................. ............................. ....................... A-30

17. Insert electrodes .......................................................................................A-32

18. Insertion of the reference electrode ........................................................A-33

19. Begin installation routines ......................................................................A-35

20. Quality control ............ .............................. ............................ .................. A-35

Shutdown ...................................................................................................................A-36

Less than 24 hours ...............................................................................................A-36

Longer than 24 hours ..........................................................................................A-36

1. Remove bottles ...........................................................................................A-36



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3 Installation and shutdown cobas b 121 system

Table of contents

2. Remove the V2 and V9 tube ends from the guides ..................................A-37

3. Insert the shutdown kit and connect it ............................... ..................... A-37

4. Remove the shutdown kit ..........................................................................A-38

5. Remove the waste container ......................................................................A-38

6. Return the V2 and V9 tube ends to the guides ............................. ........... A-387. Remove the pump tube .............................................................................A-39

8. Remove the electrodes ...............................................................................A-39

9. Remove needle and fill port ......................................................................A-40

10. Remove the printer paper ............................... .............................. .......... A-40

11. Remove the tube under V1 and V2 ........................... ............................. A-41

12. Shutting down the AutoQC module ............................. ......................... A-41

13. Uninstall the AutoQC module ................................................................A-42


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Installation

Installation

Location

For best results, choose a suitable, level location that is not subject to direct sunlightfor the device.

When installing an instrument that was stored in a cool room or was transported atlow temperatures, be aware that condensation may have formed and could causedisturbances to the instrument. Be sure that the instrument is climatized for at leastone hour at room temperature before beginning operation.

The following conditions must be fulfilled:

o Ambient temperature: + 15 °C to + 33 °C

o Ambient air pressure: 462 - 800 mmHg (61.63 - 106.60 kPa)

o Avoid direct sunlight, vibration and strong electromagnetic fields (electricmotors, transformers, X-ray equipment, cellular phones, ...).

o Use a stable and level work surface (max. 1° incline with bottles installed).

o Relative humidity:

O 20 to 95 % (at ≥ +15 °C to ≤ 31 °C)

O 20 to 90 % (at > +31 °C to ≤ +33 °C)

o Allow sufficient free space around the instrument for air circulation and the

electrical connections.o Check for the correct voltage: 100 to 240 VAC (±10%)

After setting up the instrument at a location that meets the necessary conditions,execute the following steps to ensure the instrument is ready for operation:

o Check that the instrument and all accessories are present by comparing contentswith the delivery packing slip. If anything is missing, inform your Rocherepresentative immediately.

o Inspect the instrument and the accessories for damage. If damage is noted, informthe transportation company immediately. Retain the packaging material andproducts as evidence for the damage claim.

An atmospheric pressure of 462 mmHg (61.63 kPa) corresponds to approx. 4.000 m above

sea level.


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Installation

Accessories

The following parts are delivered as standard equipment with the instrument:

Installation

1. Attach power cord and barcode scanner

1 Plug the power cord into the power supply (Figure A-8/1).

2 Connect the barcode scanner and. if necessary, the network cable (Figure A-8/2)to the respective interface(s) (Figure A-8/2) on the reverse side of the instrument.

3 Open the bottle compartment cover and the docking mechanism.

1 barcode scanner 1 shutdown kit1 power cord 1 micro electrode dummy

2 pump tubes 2 fill port holders

1 drip tray 2 needles

1 paper roll 2 MCon

(1) Power supply (2) Interfaces

Figure A-8

A Docking mechanism

Figure A-9

A


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Installation

a If available (optional equipment), install the AutoQC module.

2. Installing the AutoQC module (Automatic Quality Control Module)

1 Open the AutoQC cover and remove the transport safety band and both safetyscrews (see Figure A-11/1).

2 Remove the red plastic relief clamp by lifting from the AutoQC valve V17, which islocated toward the back of the AutoQC unit on the inside (see Figure A-11/2).

ATTENTION

Attempt to install and operate an AutoQC module only if the instrument is prepared for usewith the AutoQC module. The valves V12 and V13 must be present in the bottle compart-

ment (see Figure A-10)!

Not prepared Prepared

Figure A-10

ATTENTION

Check to be sure that the power cord is connected to the power supply. After engaging the

AutoQC module, it will no longer be possible to connect the cord to the power supply!

The safety screws are intended to fix the longitudinal and transversal slides and should

only be re-inserted whenever the AutoQC module will be transported.

(1) (2)

A Transport safety band B Red plastic relief clamp

Figure A-11

A

B


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Installation

3 On the right side of the instrument. remove the gray plastic cover from theAutoQC docking port. Close the AutoQC cover and push the AutoQC moduleinto the tracks on the instrument until it locks into place. The module's dockingport will slide into the opening on the side wall on the instrument and lock intoplace.

4 Connect both tube ends in the bottle compartment to the docking part accordingto Figure A-13.

5 Connect the cable of the AutoQC module to the jack on the reverse side of theinstrument.

A AutoQC docking port

Figure A-12

A

A

Figure A-13


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Installation

3. Switch on

Switch the instrument on and wait until the program has loaded completely and hasstarted. The instrument is in the "System stop" mode. Before beginning the start upprocedures, you must select the language with which the instrument will be operated,set the date and time, verify/activate the parameters tHb and SO2, check the baro-meter value and if the AutoQC module is activated.

4. Select language

1 Press:

h [Setup] > [Instrument] > [Language]

2 Select the language and confirm your selection.

e For a detailed description, see Reference Manual chapter Setup!

5. Setting the date and time

Press:

h [Setup] > [Times & intervals] > [Date/Time]


6. Check/Activate the parameters tHb and S O2

Press:

h [Setup] > [Parameters] > [Misc. settings] > [Act. / deact. f. measurement]


Figure A-14

Should a hardware problem occur during the booting process, the system is stopped and

an error message is given.

The Customer Service should be informed if the error occurs again.


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Installation

7. Checking the barometer value

Press:

h [More functions] > [System] > [Test] > [Control Sensors] > [Barosensor]

If the barometer value deviates by more than +/- 2 mmHg from the value indicated by

a precision barometer, it will be necessary for technical support to calibrate yourbarometer!

8. Checking the AutoQC module

Press:

h [Setup] > [Instrument] > [AutoQC]

If the AutoQC module is not activated, press this button.

Changes will be accepted after reboot.Press [Yes].

9. Installation

Press:

h [More functions] > [System] > [Tools] > [Installation]

o Follow the instructions on the screen!

Confirm every step by pressing the [Confirm] button.

10. Check tubes at V2 and V9

Check the bottle compartment's back wall to make sure that the air mixture tube(valve V2) and the ventilation tube (valve V9) are in the guides (see Figure A-15).

A Air mixture tube B Ventilation tube

Figure A-15

A

A

B


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Installation

11. Insert FMS tubes (Fluid Mixing System)

1 Slide the feed tube of the C1 solution under the tube clip (valve V1).

2 Slide the feed tube of the C2 solution under the tube clip (valve V2)(see Figure A-16).

3 Both of these valves are located on the back wall of the bottle compartment.

12. AutoQC module (option)

1 Open the cover of the AutoQC module.

2 Insert the AutoQC ampoule block.

3 Close the cover of the AutoQC module.

4 Perform the mat assignments and program the AutoQC times.

e See Chapter 6 Quality control !

A Tube of the C1 solution B Tube of the C2 solution

Figure A-16

B

A


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Installation

13. Attach pump tube

1 Open the instrument cover.

2 Open the peristaltic pump's clear plastic cover (tension lever). Push the linearbracket (white plastic part) upwards (Figure A-17).

3 Place the tube around the rolling wheel.

4 Close the clear plastic cover (tension lever). The tubing holder is then pressed intothe sealer.

14. Insert needle and fill port holder

1 Open the flap to the labelled capillary position (completely open position).

2 Insert the needle to the left into the sealing piece and then push the needlecarefully down until it clicks into place.

3 Rotate the fill port holder so that the underside shows on the top (seeFigure A-19/1) and then push this over the needle (see Figure A-19/2).

4 Snap the fill port holder evenly onto the axis (see Figure A-19/3).

Pump closed

A Tension lever

B Pump head

C Linear clamp

Figure A-17

A

B

C

Figure A-18

Do not bend the needle when pushing it up!


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Installation

5 Close the flap.

15. Insertion of printer paper

1 Open the printer cover.

2 Place the new paper roll into the holder.

3 Make sure that the printer lever is in the "down" position (see Figure A-20).

4 Cut off, at a right angle, the start of the paper.

5 Feed in the start of the paper according to the sticker on the inside of the printercover. The paper is automatically pulled into the printer.

(1) (2) (3)

Figure A-19

The printer paper is heat sensitive on one side only. Please make sure that you insert the

paper roll correctly.

A Printer lever

Figure A-20

A


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Installation

6 Close the printer cover and feed the paper outward through the slit in the printercover.

16. Insertion of bottles

1 To do this. place the bottle tool on the screw cap of the C1 or C2 (Figure A-22/1).

2 Press the grips together and press the transparent disk downward Figure A-22/2).

3 Rotate the transparent disk in the clockwise direction. Stop when you notice (aftera short distance) resistance (Figure A-22/3).

4 Scan the barcodes on the bottles of C1 calibration solution 1. C2 calibrationsolution 2 and the C3 fluid pack (the waste water bottle does not have a barcode)(see Figure A-23).

A Slit in the printer cover.

Figure A-21

A

If your facility is 3000 meters above sea level or higher deaerate the bottle before inserting

to avoid splashing the C1 and C2 solutions.

(1) (2) (3)

Figure A-22


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Installation

5 The instrument recognizes the correct solution and checks the expiration date.On the screen, the respective bottle starts blinking. If the bottle has passed the

expiration date, the screen displays a warning.

6 Confirm with this button.

7 Insert the bottle completely into the appropriate position, following theinstructions on the docking mechanism (see Figure A-24/2). The bottles areopened automatically.

8

Close the docking mechanism.Check the positions of the bottles by matching the labels on the dockingmechanisms to the labels on the bottles (see Figure A-24/3).

9 Close the bottle compartment cover.

Figure A-23

Remove rubber sealings from C3 Fluid Pack before inserting it!

(1) (2)

Figure A-24


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Installation

17. Insert electrodes

1 Open the measuring chamber cover.

2 Open locking lever.

3 Follow the instructions on the screen.

4 If necessary, remove air bubbles by holding the electrode vertically and by tappinglightly with your fingernail against the electrode body (see Figure A-26).

5 Insert the electrodes, beginning at the right and proceeding left according to thecolour code.

6 Push all electrodes slightly to the right so that they are lined up together withoutgaps.

Figure A-25

Make sure that no air bubbles have formed in the inner electrolytes of the electrodes (see

Figure A-26). If there are air bubbles between the contact pin and the membrane, there

will not be effective electrical conduction. Result: calibration and measurement errors!

A Fee of air bubbles

Figure A-26

A


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Installation

18. Insertion of the reference electrode

1 Insert the reference electrode.

2 Place the tube into the tube guide slot (seeFigure A-28/2).

3 Affix the white plug at the end of the reference electrode tube (see Figure A-29).

Figure A-27

Be sure that the tube lies precisely in the guide slot. Otherwise it may be pinched, thereby

preventing aspiration of the reference solution.

Result: calibration and measurement errors!

(1) (2)

A Locking lever

B Reference electrode

Figure A-28

A B

Push the plug in completely.


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Installation

4 Close the locking lever.

5 Inspect the electrical contact of the electrodes by checking if they fit tightly. Thecorrect position of the various electrodes is easy to recognize by looking at thecolours of the contact strips or at their labels.

6 Scan the barcodes located on the inner packaging of each electrode or enter thebarcodes manually with the help of the keyboard.

7 The corresponding electrode starts blinking on the screen.Confirm with this button.

A White plug at the end of the reference

electrode

Figure A-29

Figure A-30

A A

Always save the inside packaging materials! Whenever the instrument is taken out of

service and then brought back into service, the barcodes of the remaining functional

electrodes must be scanned again!

Figure A-31


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Installation

8 Close the measuring chamber and then the instrument cover.

19. Begin installation routines

1 Press [Start].

2 All solutions are aspirated and the system is calibrated; this may take longer thanthe respective actions during operation.

3 Installation is complete.

20. Quality control

1 You must define the material before executing a quality control measurement.

e For instructions, see Chapter 6 Quality control !

2 Perform a quality control on all 3 levels (low, normal, high).Make sure that the results agree with the target values.

e See Chapter 6 Quality control !

If an error occurs during one of the steps, a system stop is displayed, but the instrument

has been brought "into operation".

See Chapter 10 Troubleshooting , for instructions on clearing the system stop.


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Shutdown

Shutdown

Less than 24 hours

If the instrument will be needed within the next 24 hours, press:

h [More functions] > [System] > [Tools] > [Software shutdown]

Switch off the instrument.

Longer than 24 hours

If the instrument will be shut down for longer than 24 hours, perform the following

procedure.

e See Chapter 8 Operating modes, section Database > Data export – PCMCIA card (for

example) on page B-55

e See Chapter 9 Maintenance, section Decontamination on page C-5 for a detailed

description!

While in the "Analyzer" operating mode, press:

h [More functions] > [System] > [Tools] > [Shutdown]

Follow the instructions on the screen.

Confirm every step by pressing this button!

1. Remove bottles

Open the bottle compartment cover and remove bottles C1, C2 and C3.

Before shutting down the instrument, backup the data to a PCMCIA card or an interface.

Roche Diagnostics recommends decontaminating all surfaces and tubing before shutting

down the instrument.


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Shutdown

2. Remove the V2 and V9 tube ends from the guides

1 Remove the air mixture valve tube (valve V2) from the guide.

2 Remove the ventilation tube (valve V9) from the guide.

3 Place both ends of the tube onto an absorbent pad, such as a paper towel or gauze(see Figure A-33).

3. Insert the shutdown kit and connect it

1 Fill the shutdown kit about halfway with distilled water.

2 Insert the shutdown kit into space C3.

3 Connect the tubes of the set with the connectors from C1 and C2.

A Ventilation tube V9 B air mixture valve tube V2

Figure A-32

A End of the tubes

Figure A-33

A

A

B

A A


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Shutdown

4 Begin the tube washing procedure by pressing the [Start ] button.

4. Remove the shutdown kit

1 Remove the shutdown kit.

2 Start the procedure for emptying the tubes by pressing the [Start] button.

5. Remove the waste container

Remove the waste container (W waste container).

6. Return the V2 and V9 tube ends to the guides

1 Return the air mixture valve tube (valve V2) to the guides.

2 Return the ventilation tube (valve V9) to the guides (see Figure A-35).

3 Close the docking mechanisms.

Figure A-34

Remove the remaining fluid from the tubes of the shutdown kit by briefly holding the tubes

vertically, allowing the fluid to run back into the container.

A Ventilation tube B Air mixture valve tube

Figure A-35

A

A

B


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Shutdown

7. Remove the pump tube

1 Open the instrument cover.

2 Open the peristaltic pump's clear plastic cover (tension lever). Push the linearclamp (white plastic piece) upwards (see Figure A-36).

3 You can now remove the entire tube set (tube holder with tubes)(see Figure A-36).

4 Close the tension lever (clear plastic cover).

8. Remove the electrodes1 Open the measuring chamber cover.

2 Open the locking lever.

3 Remove the electrodes.

4 Close the locking lever and the measurement chamber cover.

A Tension lever

B Pump head

C Linear clamp

Figure A-36

B

A

C

A Locking lever B

Figure A-37

A


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Shutdown

9. Remove needle and fill port

1 Open the flap to the labelled capillary position (completely open position).

2 Rotate the fill port holder in the direction of the arrow (see the marking on the fillport holder). It will come out of the axis and snap out of place (seeFigure A-38/1).

3 Carefully remove the fill port holder from the needle (see Figure A-38/2).

4 Remove the needle.

5 Push the needle to the left and into the sealer. Then carefully pull it upward(see Figure A-38/3).

6 Close the flap.

10. Remove the printer paper

1 Open the printer cover.

2 Pull out the printer paper to the rear and remove it.

3 Close the printer cover.

Do not bend the needle!

(1) (2) (3)

Figure A-38


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Shutdown

11. Remove the tube under V1 and V2

1 Slide the feed tube of the C1 solution under the tube clip (valve V1) and out.

2 Slide the feed tube of the C2 solution under the tube clip (valve V2) and out.

3 Pressure is removed from the tubes.

If available (option):

12. Shutting down the AutoQC module

1 Open the cover and remove the AutoQC ampoule block.2 The carriage in the AutoQC module moves to the service position.

3 Close all covers.

4 Switch the instrument OFF.

5 Shut down is complete.

A Feed tube C1 solution B feed tube: C2 solution

Figure A-39

B

A

After successfully shutting down the instrument, it will be in the system stop mode (shut

down). Only a renewed installation procedure can alter this status.


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Shutdown

13. Uninstall the AutoQC module

1 Pull the cable of the AutoQC module from the jack on the reverse side of theinstrument (see Figure A-40).

2 Remove both tube ends in the bottle compartment from the docking port.

3 Unlock the AutoQC module by pulling the unlocking knob (see Figure A-40) onthe reverse side of the instrument and remove the AutoQC module from thetracks on the instrument.

A Unlocking knob

Figure A-40

A Tube ends B

Figure A-41

A

A

A


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Shutdown

4 Insert the red plastic relief clamp for the AutoQC valve V17.

5 If you plan to transport the instrument, be sure to unplug the power cord, thescanner, and the network cable. Then install the transport safety device for theAutoQC module.

6 Use the original packaging when transporting the instrument!

A Relief clamp for the AutoQC valve V17

Figure A-42

A Transport safety band

Figure A-43

A

A


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Shutdown


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cobas b 121 system 4 Specifications

Table of contents

Specifications

In this chapter, the performance data, as well as product and environmental data are

described.

Performance data ......................................................................................................A-47

Measured parameters ..........................................................................................A-47

Default and input values ...........................................................................................A-49

Sample throughput ...................................................................................................A-49

Sample volume ..........................................................................................................A-49

Sample types ..............................................................................................................A-50

Calibrations ...............................................................................................................A-50

Environmental parameters .......................................................................................A-51

Temperature / humidity / stability .............................. ............................. .......... A-51

Product data ..............................................................................................................A-53

Electrical data ......................................................................................................A-53

Classification (according IEC/ISO) ....................................................................A-53

Dimensions ..........................................................................................................A-53

Weight ..................................................................................................................A-53

Printer ........................................................................................................................A-53

Screen .........................................................................................................................A-54

Barcode scanner ........................................................................................................A-54



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4 Specifications cobas b 121 system

Table of contents


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Performance data

Performance data

Measured parameters

specified

for

Specified range Precision(a) (b)

(within-run)

Precision (a) (b)

(day-day)

Accuracy(a)

P O2 B 0 - < 60 mmHg SD < 4.0 mmHg SD < 6.0 mmHg < ± 8.0 mmHg

60 - 140 mmHg SD < 2.0 mmHg SD < 3.0 mmHg ± 4.0 mmHg

> 140 - 500 mmHg SD < (2% - 0.8 mmHg) SD < (4% - 2.6 mmHg) < ± (6% - 4.4 mmHg)

> 500 - 800 mmHg SD < (4% - 11.8 mmHg) SD < (8% - 22.6 mmHg) < ± (12% - 34.4 mmHg)

0 - > 7.998 kPa SD < 0.533 kPa SD > 0.800 kPa < ± 1.066 kPa

7.998 - 18.662 kPa SD < 0.267 kPa SD < 0.400 kPa ± 0.533 kPa

> 18.662 - 66.650 kPa SD < (2% - 0.107 kPa) SD < (4% - 0.347 kPa) < ± (6% - 0.587 kPa)> 66.650 - 106.640 kPa SD < (4% - 1.573 kPa) SD < (8% - 3.013 kPa) < ± (12% - 4.586 kPa)

Q 0 - < 60 mmHg SD < (10.7 - 12%) mmHg SD < (12.2 - 12%) mmHg < ± (16.8 - 13%) mmHg


> 200 - 800 mmHg SD < (7% - 10.5) mmHg SD < (7% - 9.0) mmHg < ± (6..5% - 4) mmHg

0 -< 7.998 kPa SD < (1.426 - 12%) kPa SD < (1.626 - 12%) kPa < ± (2.239 - 13%) kPa


26.660 - 106.640 kPa SD < (7% - 1.400) kPa SD < (7% - 1.200) kPa < ± (6.5% - 0.533) kPa

P CO2 B/Q 4 - < 15 mmHg SD < 2 mmHg SD < 3 mmHg ± 4 mmHg


> 80 - 200 mmHg SD < 4.5 mmHg SD < 6 mmHg ± 8 mmHg0.533 - < 2.00 kPa SD < 0.267 kPa SD < 0.400 kPa ± 0.533 kPa



pH B/Q 6.0 - < 6.8 SD < 0.020 SD < 0.035 ± 0.06

6.8 - 7.6 SD < 0.008 SD < 0.015 ± 0.02

> 7.6 - 8.0 SD < 0.015 SD < 0.030 ± 0.04

Na+ B/S/A/D/Q 20 - < 120 mmol/L SD < 4.5 mmol/L SD < 6 mmol/L ± 8 mmol/L

120 - 170 mmol/L SD < 1.5 mmol/L SD < 2.0 mmol/L ± 2.5 mmol/L

> 170 - 250 mmol/L SD < 6 mmol/L SD < 8 mmol/L ± 10 mmol/L

K +

B/S/A/D/Q 0.2 - < 3.0 mmol/L SD < 0.15 mmol/L SD < 0.35 mmol/L ± 0.5 mmol/L3.0 - 6.0 mmol/L SD < 0.06 mmol/L SD < 0.15 mmol/L ± 0.2 mmol/L

> 6.0 - 20 mmol/L SD < 0.4 mmol/L SD < 1 mmol/L ± 1.4 mmol/L

Cl- B/S/A/D/Q 20 - < 70 mmol/L SD < 3 mmol/L SD < 4 mmol/L ± 8.0 mmol/L

70 - 130 mmol/L SD < 1.5 mmol/L SD < 2.0 mmol/L ± 4.0 mmol/L

> 130 - 250 mmol/L SD < 4.5 mmol/L SD < 6 mmol/L ± 12.0 mmol/L

Table A-1


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Performance data

Ca2+ B/S/A/D/Q 0.1 - < 0.6 mmol/L SD < 0.06 mmol/L SD < 0.1 mmol/L ± 0.2 mmol/L

0.6 - 1.5 mmol/L SD < 0.03 mmol/L SD < 0.05 mmol/L ± 0.1 mmol/L

> 1.5 - 4.0 mmol/L SD < 0.15 mmol/L SD < 0.25 mmol/L ± 0.5 mmol/L

0.4008 - < 2.4048 mg/dL SD < 0.2405 mg/dL SD < 0.4008 mg/dL ± 0.8016 mg/dL

2.4048 - 6.0120 mg/dL SD < 0.1202 mg/dL SD < 0.2004 mg/dL ± 0.4008 mg/dL

> 6.0120 - 16.0320 mg/dL SD < 0.6012 mg/dL SD < 1.0020 mg/dL ± 2.0040 mg/dL

Hct B/Q 10 - < 20% SD < 3% SD < 5% ± 6.0%

20 - 60% SD < 1.5% SD < 2.5% ± 3.0%

< 60 - 80% SD < 3% SD < 5 % ± 6.0%

0.100 - < 0.200 SD < 0.030 SD < 0.050 ± 0.060

0.200 - 0.600 SD < 0.015 SD < 0.025 ± 0.030

< 0.600 - 0.800 SD < 0.030 SD < 0.050 ± 0.060

tHb B 3 - < 6 g/dL SD< (3.0% + 0.27 g/dL) SD < (3.3% + 0.30 g/dL) < ± (-3.3% + 0.70 g/dL)

6 - 18 g/dL SD < 0.45 g/dL SD < 0.5 g/dL < ± 0.5 g/dL

> 18 - 25 g/dL SD < (2.1% + 0.06 g/dL) SD < (2.1% + 0.11 g/dL) 180.00 - 250.00 g/L SD < (2.1% + 0.60 g/L) SD < (2.1% + 1.10 g/L)


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Default and input values

Default and input values

Sample throughput

Sample volume

Parameter Default values Range (default values) Range (input values)

tHb 15.0 g/dL 11,0 - 16.0 g/dL 1.0 - 26.0 g/dL

150.0 g/L 110.0 - 160.0 g/L 10.0 - 260.0 g/L

9.3 mmol/L 6.8 - 9.9 mmol/L 6.2 - 161.3 mmol/L

P 50 Adult 26.7 mmHg not editable not editable

3.56 kPa

P 50 Fetal 21.5 mmHg not editable not editable

2.87 kPa

F IO2 0.21 0.1 - 1.0 0.1 - 1.0

R 0.84 0.7 - 2.0 0.7 - 2.0

Patient temperature 37.0 °C 2.0 - 44.0 °C 2.0 - 44.0 °C

98.6 °F 35.6 - 111.0 °F 35.6 - 111.0 °F

Table A-2

Activated / installed

electrodes

Typical sample throughput

[samples / hours]

Syringe Capillary

BG - tHb/SO2 30 30

BG - ISE - tHb/SO2 30 30

Table A-3

If the sample contains a higher Hct concentration, a sample volume of up to 70 µL is

required!

Activated / installed electrodes Typical sample volume

[µL](a) Typical specimen volume

(capillary position)

[µL](b)

Typical specimen volume

(syringe position)

[µL](c)

BG - ISE - tHb/SO2 60 68 90

(a) typical for Hct≤ 45%

(b) Volume limitation through sample sensor: If the specified volume is reached, an aspiration stop occurs (approx. 1 second). If the capillary is notremoved, the aspiration process continues.

(c) No aspiration stop in the syringe position.


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Sample types

Sample types

o Whole blood

o Serum

o Plasma

o Dialysis solutions containing acetate

o Dialysis solutions containing bicarbonate

o QC material

Calibrations

Calibrations Time intervals Length (typical)

[min]

Sys cal every 24 hours

(alternatively 8, 12 or 24 hours)

< 15

1P cal every 30 minute (alternatively 1 hour) < 2

2P cal every 12 hours

(alternatively 4, 8, 12 hours)

< 7

Warm-up phase when turning (a)

(a) incl. calibration

< 25

Warm-up phase power fail < 1 minute < 2

Electrode exchange as needed < 27

Table A-4


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Environmental parameters


Temperature / humidity / stability

Instrument

Electrodes

Operating conditions

o Ambient temperature +15 °C to +33 °C

o Ambient air pressure 462 - 800 mmHg (61.63 - 106.60 kPa)(a)

(a) TIP: An atmospheric pressure of 462 mmHg (61.63 kPa) corresponds to approx. 4,000 m above sea level.

o Sea level -400 m to +4000 m

o Relative humidity 20 - 95%, if T > +15 °C to ≤ +31 °C

20 - 90%, if T > +31°C to +15 °C to ≤ +31 °C

20 - 90%, if T > +31 °C to


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Solutions

QC material

Operating conditions

o Ambient temperature +15°C to +33 °C

o Relative humidity 20 - 95%, if T > +15 °C to ≤ +31 °C

20 - 90%, if T > +31 °C to


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Product data

Product data

Electrical data

Classification (according IEC/ISO)

Dimensions

Instrument

AutoQC-Modul

Weight

Printer

Mains voltage range: 100 to 240 VAC (±10% permissible tolerance)

Frequency: 50/60 Hz

Required power: 150 W

Protection class: I

Overvoltage category: IIContamination level: 2

Width: 35.4 cm

Heigth: 46.7 cm

Depth: 41.0 cm

Width: 19.5 cmHeigth closed: 19.8 cm (open: 38.7 cm)

Depth: 39.5 cm

cobas b 121 system (instrument): about 17 kg (without calibration solutions)

cobas b 121 system ready for shipment: about 23 kg

AutoQC module: 5.9 kg (without ampoule mats)

Type: thermal printer with integrated paper cutter

Resolution: 12 dots/ mm

Full graphics: 576 dots / line

Printing speed: 8 mm / sec

Paper width: 58 mm

Paper length: ca. 30 m


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Screen

Screen

Barcode scanner

Type: integrated flat LCD screen

Format: 5.7 inch

Resolution: 320 x 240 pixel

Type: PS2 hand-held scanner with integrated decoder

Reading speed: up to 45 scans/sec.

Resolution: 0.1 mmReading distance: up to 5 cm

Reading width: up to 8 cm

Preprogrammed code types(a):

(a) Further available barcode types can be programmed in accordance with the enclosed manual of thePS2 hand-held scanner (included in scope of delivery).

o China Postal Code

o Codabar

o Code 39

o Code 128

o EAN-8

o EAN-13

o EAN-128

o Interleaved 2 of 5

o UPC-A

o UPC-E


67/192

June 2008

5 Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

6 Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-15

7 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-35

8 Operating modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-41

Operation B


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Instructions for Use · Version 10.0 B-3

cobas b 121 system 5 Measurement

Table of contents

Measurement

In this chapter, all information necessary for carrying out measurements is described.

Preanalytics .................................. ................................. ............................... ................ B-5

Sample collection ............................. ................................ ................................ ..... B-5

Sample acquisition ............................ ............................... ............................... B-5

Acceptable anticoagulants ........................... ............................. ....................... B-5

Sample collection especially for tHb, SO2 and Hct measurement ................ B-5

Sample collection containers ....................................... ............................... .......... B-6

Syringes ............................... ................................. ............................... ............. B-6

Capillary tubes ............................ .................................. ................................. .. B-6

Roche MICROSAMPLER® ........................... ............................ ...................... B-6

Clot catcher .......................... ................................ .............................. .............. B-6

Sample handling .............................. ................................ ................................ ...... B-7

Whole blood ......................................................... .............................. ............. B-7

Serum ............................. ................................ .............................. .................... B-7

Plasma ............................ ................................ ............................. ..................... B-7

Measuring procedure ........................... ................................ ................................ ....... B-8

Syringe mode ........................... ................................ .............................. ................ B-9

Capillary mode ............................ ................................ ............................. ........... B-10

Data input .............................. ................................ .............................. ................ B-12

Results display / measurement report ........................... ............................. ........ B-13



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Instructions for Use · Version 10.0 B-5

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Preanalytics

Preanalytics

Sample collection

e Please refer to CLSI document M29-A3, "Protection of Laboratory Workers from

occupationally acquired infections." Approved guidelines - Third Edition 2005.

Sample acquisition

Only qualified personnel may perform the collection of blood needed for analyticalpurposes.

e For detailed information about blood sampling, storage and handling, see for example

CLSI document H11-A4, "Procedures for the collection of arterial blood specimes;

Approved Standard (Fourth Edition 2004)".

Acceptable anticoagulants

The only clot inhibitors that may be used for analyses in the cobas b 121 system areheparin salts. Other clot inhibitors, such as EDTA, citrate, oxalate, fluoride, andammonium-based materials have significant influence on the blood's pH and otherparameters and may not be used for this reason.

Sample collection especially for tHb, S O2 and Hct measurement

Whole blood, especially for the analysis of tHb, SO2 and Hct, must be thoroughly

mixed immediately before analysis in order to achieve consistent distribution of redblood cells and plasma before insertion of the sample.

Carefully rotate the sample about two axes using your hand or a mechanical device orinsert a metal disk or ball in the syringe before collecting the sample. Shortly beforeusing the sample, carefully shake the syringe. The up and down motion of the disk orball inside the syringe cylinder ensures consistent mixing.

e Refer to CLSI document C46-A "Blood gas an pH analysis related measurements;

Approved Guideline 2001".

Follow the usual applicable safety precautions when drawing blood samples. When

handling blood samples, there always exists the danger of transmission of HIV, hepatitis B

and C viruses or other pathogens transmissible by blood. Employ suitable blood sampling

techniques in order to reduce risk to personnel.

Suitable protective equipment, like laboratory clothing, protective gloves, protective

goggles and if necessary mouth protectors, must be worn to prevent direct contact with

biological working materials. In addition, a face mask is required if there is a risk.

The puncture site may never be squeezed! Mixing the blood sample with tissue fluid may

lead to the premature onset of clotting despite sufficient heparinization of the sample

collection containers! Incorrect sample collection or the use of an unsuitable sample

collection container may lead to errors and discrepancies in the measurement values.


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Preanalytics

Sample collection containers

Syringes

If using another manufacturer's product with liquid heparin as a clot inhibitor, thecollection container should not be larger than required for the blood volume. Thiswill minimize the effects of the clot inhibitor on the thinning of the blood. The use ofplastic syringes is common, but there are cases when the use of plastic syringes is notappropriate, for example, when P O2 values are expected to be outside the normalrange. If very high P O2 values are expected, the sample should be analyzed as quicklyas possible after the specimen collection.

Capillary tubes

The capillary tubes must have a minimum volume of 100 μ L.

Capillary tubes with ceramic sealing caps should not be used because the fracture thatforms when opening the capillary can damage the fill port of the instrument. Use onlycapillary tubes with heat-treated ends to avoid damage to the instrument. When usingstirring rods like those offered by a few manufacturers, remove these rods beforeinserting the sample in order to avoid clogging the instrument.

Roche MICROSAMPLER®

The Roche MICROSAMPLER, which consists of two capillary tubes (115 μL each) ina plastic container, is ideally suited to atraumatic arterial blood collection.

Each laboratory should document the permissibility of sample containers that areused. These products vary from manufacturer to manufacturer and sometimes fromlot to lot.

Clot catcher

The use of a clot catcher is recommended to prevent clogging of the sample path dur-ing measurement of critical

Documents

Instructions for Use Cobas b121 en[1]