Instructions for Use Cobas b121 en[1]

cobas b

121 system

Instructions for Use

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

coba cobas s b 121 121 syst system em

Revision History Manual Version

Software Version

2.0

Revision date

Changes

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

Edition notice coba cobass b 121 system system

In the course course of 2005 the Roche Roche OMNI C system system was rebranded rebranded under the Roche Roche Diagnostics professional IVD user brand cobas®. cobass b 121 system Systems with a serial number of 5000 or above are coba system..

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

Copyright © 2008, Roche Diagnostics GmbH. All rights reserved The contents of this document may not be reproduced in any form or communicated to any third party without the prior written consent of Roche Diagnostics. While every effort is made to ensure ensure its correctness. correctness. Roche Diagnostics assumes no responsibility for errors or omissions which may appear in this do cument. Subject to change without notice.

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

Roche Diagnostics Instructions for Use · Version 10.0

June 2008 1


Contact addresses Manufacturer

Roche Diagnostics GmbH D-68298 Mannheim / Germany www.roche.com

Edition Revision 10.0, June 2008 First edition: October 2001 REF/No. 03260992001

Roche Diagnostics 2

June 2008 Instructions for Use · Version 10.0


Table Table of contents Revision History Edition notice Copyright Brands Contact addresses Edition Table of contents Preface How to use this manual Where to find information Conventions Conventions used in this manual

Introduction and specifications 1

Calibration - general 8

A-9 A-10 A-12 A-13 A-15

A-21 A-36

Spec Specif ific icat atio ions ns

Performance data Default and input values Sample throughput Sample volume Sample types Calibrations Environmental parameters Product data Printer Screen Barcode scanner

A-47 A-49 A-49 A-49 A-50 A-50 A-51 A-53 A-53 A-54 A-54

Oper Operat atin ing g mode modes s

B-43 B-43 B-49 B-61

Part C

Maint intenance

Maintenance - general Decontamination Daily Weekly Semi annual Sample-dependent maintenance procedures Unscheduled Additional maintenance procedures Maintenance overview Maintenance scheduler

Troubleshoot Troubleshooting ing

C-5 C-5 C-7 C-8 C-9 C-10 C-17 C-30 C-31 C-32

Part D

10 Troubleshoo roubleshooting ting

Troubleshooting - general System stops List of system stops Electrode status

Appendix Operation

B-37

Operating modes - general User interface Analyzer mode Software overview

9

B-19 B-20 B-26 B-28 B-30 B-31 B-32

Calib alibrratio ation n

Maintenance

Inst Instal allat lation ion and and shut shutdo down wn

Installation Shutdown 4

7

A-5 A-6

Gene Generral desc descri ript ptio ion n

Introduction General notes Measurement Measurement and calibration procedure Safety instructions for specific dangers System description 3

Part A

Important information concerning the analysis of QC measurement results Material setup QC measurement Multirules QC consequences consequences QC unlock QC troubleshooting

Safe Safety ty inf infor orma mati tion on

Important information Operating safety information 2

1 1 1 1 2 2 3 5 5 5 5

D-5 D-5 D-7 D-14

Part E

Part B 11 List List of consuma consumable bles s

5

Mea eas surement

Preanalytics Measuring procedure 6

Order information B-5 B-8

Index

E-5

Part F

Qual Qualit ity y con contro trol

Quality control - general General QC concept Roche Diagnostics Instructions for Use · Version 10.0

B-17 B-17

Index

F-3 June 2008 3


Roche Diagnostics 4



Preface cobass b 121 system features This manual has detailed descriptions of coba features and general operational concepts, specification functions and use of controls, operating techniques, emergency procedures, product labeling and maintenance procedures.

How to use this manual 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.

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

Where to find information In addition to the Instructions for Use, the fol lowing documents are also provided to assist in finding desired information quickly: o

coba cobass b 121 system Reference Reference Manual

o

system Short Instruction coba cobass b 121 system

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

Helping to locate and interpret information in this manual the following symbols are used: Symbol

Description

a

Procedural step

o

List item

e

Cross-reference

h

Call up of screen Note


June 2008 5


Symbol

Description Attention, Warning, Warning, Danger

All sections / passages that are marked with this symbol describe procedures and/or indicate conditions conditions or dangers that could damage cobass b 121 system, and which or lead to a malfunction in the coba 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.

IVD symbols

The IVD symbols are used in accordance with DIN EN 980:2003, ISO 15223:2000 (as per the In Vitro Diagnostics Directive 98/79/EC), and DIN EN ISO 780:1997. 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 Manufacturer — according 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 (according to the standard DIN ISO 15223-1:2005)(Consumables) 15223-1:2005)(Consumables) Catalogue number

Roche Diagnostics 6



Symbol

Description

Caution (refer to accompanying documents). Please refer to safetyrelated notes in the manual, accompanying this instrument. Please consult instructions for use

Serial number (model plate)

Other symbols

The following symbols are listed as additional information: 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 Fluid Pack Pack)) Rating: Although not corrosive, momentary, 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 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.


June 2008 7


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 approximates the audible range of the human ear.

DIL

Diluent

DN S

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

Roche Diagnostics 8

MAC

Media Access Control

MC

Measuring chamber

MCon

Measuring contact

MSDS

Material safety data sheet

MSS

Metabolite sensitive sensor

MV

Mean value June 2008 Instructions for Use · Version 10.0


Abbreviation

Definition

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 hemoglobin

U

UL

Under writers Laboratories Inc.

V

VDE

e


Association of German Electrical Engineers (Verband (Verband Deutscher Elektrotechniker)

For writing the measuring, calculated and input values see Chapter 8 Operating modes > Parameter on on page B-73! B-73!

June 2008 9


Roche Diagnostics 10


Introduction and specifications

A

1

Safe Safety ty info informa rmatio tion n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 A-3

2

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

3

Inst Instal alla latio tion n and and shu shutd tdown own . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-19 A-19

4

Speci Specifi fica catio tions ns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-45 A-45

June 2008

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.

In this chapter

Chapter

1

Important information ...............................................................................................A-5 Operating safety information .....................................................................................A-6


June 2008 A-3

1 Safety information

cobas b 121 system

Table of contents

Roche Diagnostics A-4


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 are explained to ensure smooth operation. No warranty or liability claims will be covered if the machine is used in ways other than those described or if the necessary prerequisites and safety measures are not observed. The instrument may be operated only by persons whose qualifications enable them to comply with the safety measures that are necessary during operation of the instrument. 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 t here is a risk. Adjustments and maintenance performed with covers removed and power connected may be attempted only by a qualified technician who is aware of the associated dangers. Instrument repairs are to be performed only by the manufacturer or qualified servi ce personnel. Only accessories and supplies either delivered by or approved by Roche are to be used with the instrument. These items are manufactured especially f or use with this instrument and meet the highest quality qualit y requirements. Operation of the instrument with solutions whose composition is not consistent with that of the original ori ginal solutions can negatively affect the long-term measurement accuracy. accuracy. Deviations in the composition of the solutions can also decrease the service life of the electrodes. For safety reasons, quality qualit y control measurements must be performed daily. Since the measurements of the instrument depend not only on the correct characteristic function, but also on a series ser ies of marginal conditions (e.g. pre-analysis), results obtained from the instrument should be submitted for an expert opinion before taking additional measures based on the supplied measurements. Caution (refer to accompanying documents)! WARNING


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

June 2008 A-5

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 61010-1:2001

o

IEC/EN 61010-2-101:2002 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 safet y features. In order to preserve this condition and ensure safe operation, the user must respect the notices and warnings that are contained in these Instructions for Use.

WARNING


o

This instrument is classified under the protection class I according to IEC/EN IEC/EN 6101 61010-1. 0-1.

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 i n an explosive environment environment or in the vicinity vi cinity of explosive anesthetic mixtures containing oxygen or nitrous oxide.

o

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

o

The instrument is suitable for long-term operation i ndoors.

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

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


cobas b 121 system

2 General description Table of contents

General description

This chapter contains a general description of the instr ument, as well as precautionary measures against special dangers and the proper handling of sensors and solutions.

In this chapter

Chapter

2

Introduction ................................................................................................................A-9 General notes .............................................................................................................A-10 Application area ...................................................................................................A-10 Operating instructions ........................................................................................A-10 Important 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, water, bottles, electrodes, and the instrument ..................... A-13 Decontamination ................................................................................................A-13 Handling solutions ..............................................................................................A-13 Handling electrodes ............................................................................................A-14 System 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-17 Interface .........................................................................................................A-17 Roche Diagnostics Instructions for Use · Version 10.0

June 2008 A-7

2 General description

cobas b 121 system

Table of contents

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



cobas b 121 system

2 General description Introduction

Introduction

Figur Figure e A-1

cobass b 121 system is a modular analyzer for measuring blood gases, electrolytes, The coba 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 adjust ments during 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, pat ients, measurement, calibration, QC, and the instrument

o

Setup: instrument settings

o

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

The instrument is currently available in the following configuration: o

BG (pH, P O2, P CO 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 footpr int, and reduced costs. An easily understood "Touch "Touch Screen" interface facilitates easy operation and saves costly and time-consuming user training. The patented electrodes are completely maintenance-free, and only require a very small sample volume.


June 2008 A-9


cobas b 121 system

General notes

General notes Application area The instrument is designed to measure BG / ISE / tHb/SO2 in whole blood. The accuracy of measurement values is checked accordingly. accordingly. In order to achieve accurate measurements of recommended aqueous control solutions (with regards to deviations from f rom biological samples), choose the proper components and make the corresponding corrections in the QC measurement mode. The accuracy of measurement values of undefined aqueous solutions cannot be guaranteed (e.g. due to the possibility poss ibility of interfering components and/or missing or insufficient buffer systems, and/or differences in ionic strength and diffusion potential 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 to carry out shutdown procedures. e

For more information, see Chapter 3 Installation and shutdown !

Prevent fluids leaking inside the analyzer. 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 exchange of solutions and packs and after startup of the instrument. Additionally complete a quality control test on one le vel between two automatic 2P calibrations. The levels have to be alternated (low, (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



cobas b 121 system

2 General description General notes

Buttons

Description

Confirm

Cancel

Activate / deactivate

Start action

e


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

June 2008 A-11


cobas b 121 system

Measurement and calibration procedure

Measurement and calibration procedure 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 by the reduction of oxygen

CO2 : Use of the Severinghouse principle: potentiometric measurement of the pH P CO change in the electrode caused by CO2. pH, Na+, K+, Ca2+ and Cl– are potentiometric electrodes. Special glasses are used as the sensitive element for pH and Na+. The potassium and calcium membranes contain special neutral carriers. A special ion exchanger is used for chloride membranes. Calculation of these variables also requires the use of a reference electrode - a permanently contacted chloride electrode in the instrument. tHb /SO2 : Light absorption absorpti on in whole blood is measured at four different di fferent wavelengths, wavelengths, whereby on one hand the sample is subjected to light radiation and on the other hand the 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 to calibrate 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 two calibration points for each measurement variable and constant internal monitoring of the calibrations ensures the accuracy and precision of the measurement values.

Measurement evaluation The results from the instrument must be carefully examined by a clinical-medical specialist who will take t ake the patient's clinical condition into consideration before any clinical 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 exchange of solutions and packs and after startup of the instrument. Additionally complete a quality control test on one le vel between two automatic 2P calibrations. The levels have to be alternated (low, (low, normal, high). e


For more information, see Chapter 6 Quality control !


cobas b 121 system

2 General description Safety instructions for specific dangers

Safety instructions for specific dangers Handling samples Respect the necessary hygienic regulations when handling samples because samples may contain dangerous viruses. e

For more detailed information, see Chapter 5 Measurement !

Disposal of waste water, bottles, electrodes, and the instrument Dispose waste water, bottles, electrodes and the instrument according to local and/or labour regulations (biologically contaminated—hazardous waste!)

Decontamination The purpose of this procedure is to minimize r isk when handling items that were in contact with biological samples. Roche recommends following a decontamination procedure in addition to regulations specific to the laboratory. laborator y. These decontamination procedures should be performed periodically to minimize the risk of infections (incl. hepatitis virus and HIV). Always wear gloves! e

For more detailed information about decontamination, 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 t he correct storage temperature and the maximum shelf life. CAUTION! CAUTION! DO NOT FREE ZE! If frozen, the solution's concentration may change and cause calibration errors! ATTENTION


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

June 2008 A-13


cobas b 121 system

Safety instructions for specific dangers

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 the maximum shelf life. NOTE

IMPORTANT! Installation note for the P CO 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 CO 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 calibration is completed. 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.



cobas b 121 system

2 General description System description

System description Visual identification

I

A

H

B

G

C F

D E

A

Printer cover

B

Pump

C

Power pack / main switch

G

Flap

D

Unlocking knob for the AutoQC module

H

Contrast setting

E

Bottle compartment

I

Screen

F

Measurement chamber with the electrodes and tHb/ S O2 module

Figur Figure e A-2

Screen All information (results, error messages, warnings, etc.) is di splayed 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 i s located underneath the printer cover.


June 2008 A-15


cobas b 121 system

System description

Measurement chamber The measurement chamber with the electrodes and the tHb/ SO2 module are located beneath 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 total hemoglobin (tHb) and oxygen saturation (SO2) in whole blood.

Pump A peristaltic pump transports the sample and the operating fluids inside the instrument.

Flap When opening the flap, notice two definitive lo cking positions: o

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

o

Flap position 2 (completely opened) – Capillary mode—for capillaries and Roche Roche MICROSAMPL MICROSAMPLERs ERs

Bottle compartment The calibration solutions and the waste container are located b ehind 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"

Figur Figure e A-3



cobas b 121 system

2 General description System description

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

A

B

C

D

A

COM 1

C

Barcode Scanner

B

COM 2

D

Network connection

Figur Figure e A-4

COM 1*

RS 232 Schnittstelle

COM 2*

RS 232 Schnittstelle

Barcode

PS/2 DIN - 6p Buchse

Network

10BaseT Ethernet (RJ45)

*TIP: Always use a filter adapter when using the serial interface. Order this part from your customer service representative!

COM 1

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

COM 2

This interface can be assigned as serial interface to ASTM. e


For an exact description of the assignment, see Reference Manual chapter chapter Setup, section Interfaces > COM 1 .

For an exact description of the assignment, see Reference Manual chapter chapter Setup, section Interfaces > COM 2 .

June 2008 A-17


cobas b 121 system

System description

Barcode scanner

Figur Figure e A-5 o

Scanning of solution data (ty pe, lot number, expiration date current composition, etc.)

o

Scanning of electrode data (type, (ty pe, 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

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. ATTENTION e

For further information, see the enclosed manual for the PS2 hand-held scanner (included in scope of delivery).

Warning and identification labels

Figur Figure e A-6

Identification label

A A

Identification label

Figur Figure e A-7 Roche Diagnostics A-18


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.

In this chapter

Chapter

3

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 AutoQC module (Automatic (Automatic Quality Control Module) 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 Checking the AutoQC AutoQC module ............................................................... .............................. ..................................... A-26 9. Installation .................................................................................................A-26 10. Check tubes at V2 and V9 .......................................................................A-26 11. Insert 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 Roche Diagnostics Instructions for Use · Version 10.0

June 2008 A-19

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-38 7. 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 Remove the tube under V1 and V2 ........................................................ ........................... ............................. A-41 12. Shutting down the AutoQC module ...................................................... ............................. ......................... A-41 13. Uninstall the AutoQC module ................................................................A-42



cobas b 121 system

3 Installation and shutdown Installation

Installation Location For best results, choose a suitable, level location that is not subject to direct sunlight for the device. When installing an instrument that was stored in a cool room or was transported at low temperatures, be aware that condensation may have formed and could cause disturbances to the instrument. Be sure that the instrument is climatized for at least one 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)

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

Avoid Avoid direct sunlight, vibration and strong electromagnetic fields (electric motors, 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 contents contents with the delivery packing slip. If anything is missing, inform your Roche representative immediately. immediately.

o

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

June 2008 A-21


cobas b 121 system

Installation

Accessories The following parts are delivered as standard equipment with the instr ument: 1 barcode scanner

1 shutdown kit

1 power cord

1 micro electrode dummy

2 pump tubes

2 fill port holders

1 drip tray

2 needles

1 paper roll

2 MCon

Installation 1. Attach power cord and barcode scanner 1

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

2

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

(1) Power supply

(2) Inter faces

Figur Figure e A-8 3

Open the bottle compartment cover and the docking mechanism.

A

A

Docking mechanism

Figur Figure e A-9 Roche Diagnostics A-22


cobas b 121 system


a

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

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

ATTENTION

Attempt to install and operate an AutoQC module only if the instrument is prepared for use with the AutoQC module. The valves V12 and V13 must be present in the bottle compartment (see Figure Figure A-10 A-10)!

Not prepared

Prepared

Figure Figure A-10 A-10

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! ATTENTION 1

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

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. 2

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

B A (1)

A

Transport safety band

( 2)

B

Red plastic relief clamp

Figure Figure A-11


June 2008 A-23


cobas b 121 system

Installation

3

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

A

A

A

AutoQC docking port

Figure Figure A-12 4

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

5

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

Figure Figure A-13



cobas b 121 system



3. Switch on Switch the instrument on and wait until the program has loaded completely and has started. The instrument is in the "System stop" mode. Before beginning the start up procedures, 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 barometer value and if the AutoQC module is activated. 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.

4. Select language 1

Press:

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

2 e

Select the language and confirm your selection. For a detailed description, see Reference Manual chapter chapter Setup!

5. Setting the date and time Press: h [Setup] > [Times & i ntervals] > [Date/Time] e

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

6. Check/Activate the parameters tHb and S O2 Press: h [Setup] > [Parameters] > [Misc. settings] e


> [Act. / deact. f. measurement]

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

June 2008 A-25


cobas b 121 system

Installation

7. Checking the barometer value Press: h [More functions] >

[System] > [Test] [Test] > [Control Sensors] > [Barosensor]

If the barometer value deviates by more than +/- 2 mmHg from the value indicated by a precision barometer, barometer, it will be necessary for technical support to calibrate your barometer! 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] > o

[System] > [Tools] [Tools] > [Installation]

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 Figure A-15 A-15). B

A

A

A

Air mixture tube

B

Ventilation tube

Figure Figure A-15



cobas b 121 system


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 Figure A-16 A-16).

3

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

B

A A

Tube of the C1 solution

B

Tube Tube of the C2 solution

Figure Figure A-16

12. AutoQC module (option) 1

Open the cover of the AutoQC module.

2

Insert the AutoQC ampoule block.

3

Close the cover of the t he AutoQC module.

4

Perform the mat assignments and program the AutoQC times.

e


See Chapter 6 Quality control !

June 2008 A-27


cobas b 121 system

Installation

13. Attach pump tube 1

Open the instrument cover. cover.

2

Open the peristaltic pump's clear plastic plasti c cover (tension lever). Push the linear bracket (white plastic part) upwards (Figur (Figuree A-17 A-17).

3

Place the tube around the rolling wheel.

4

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

A

B C

Pump closed

A

Tension leve r

B

Pump head

C

Linear clamp


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 needle carefully down until it clicks into place.


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

Do not bend the needle when pushing it up!

4


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


cobas b 121 system


( 1)

(2)

(3)


Close the flap.

15. Insertion of printer paper The printer paper is heat sensitive on one side only. Please make sure that you insert the paper roll correctly. correctly. 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 Figure A-20 A-20).

A

A

Printer lever

Figure 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 printer cover. cover. The paper is automatically pulled into the printer.

June 2008 A-29


cobas b 121 system

Installation

6

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

A

A

Slit in the printer cover.

Figure Figure A-21

16. Insertion of bottles 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

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

2

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

3

Rotate the transparent disk in the clockwise direction. Stop when you notice (after a short distance) resistance (Figur (Figuree A-22 A-22/3).

(1)

(2)

(3)



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


cobas b 121 system



The instrument recognizes the correct solution and checks the expiration date. On the screen, the respective bottle starts blinking. bl inking. If the bottle has passed the expiration date, the screen displays a warning.

6

Confirm with this button.

Remove rubber sealings from C3 Fluid Pack before inserting it!

7

Insert the bottle completely into the appropriate positi on, following the instructions on the docking mechanism (see Figure Figure A-24 A-24/2). The bottles are opened automatically.

8

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

( 1)

(2)



Close the bottle bott le compartment cover.

June 2008 A-31


cobas b 121 system

Installation

17. Insert electrodes 1

Open the measuring chamber cover.

2

Open locking lever. lever.

3

Follow the instructions on the screen.

Figure Figure A-25

Make sure that no air bubble s have formed in the inner electrolytes of the electrodes (see Figure Figure A-26 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! 4

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

A

A

Fee of air bubbles

Figure Figure A-26


5

Insert the electrodes, beginning at the right r ight and proceeding left according to the colour code.

6

Push all electrodes slightly to the right so that they are lined up together without gaps.


cobas b 121 system


18. Insertion of the reference electrode 1

Insert the reference electrode.


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

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!

A

B (1)

A

Locking lever

B

Reference electrode

(2)


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

Push the plug in completely. completely.


June 2008 A-33


cobas b 121 system

Installation

A A

A

White plug at the end of the reference electrode


Close the locking lever.

5

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


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

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!



The corresponding electrode starts blinking on the screen. Confirm with this button. June 2008 Instructions for Use · Version 10.0

cobas b 121 system


8

Close the measuring chamber and then the i nstrument cover. cover.

1

Press [Start].

2

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

3

Installation is complete.

19. Begin installation routines

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.

20. Quality control 1

You must define the material before executing a qualit y control measurement. e

2

e


For instructions, see Chapter 6 Quality control !

Perform a quality control on all 3 levels (low, normal, high). Make sure that the results agree with the target values. See Chapter 6 Quality control !

June 2008 A-35


cobas b 121 system

Shutdown

Shutdown Less than 24 hours If the instrument will be needed within the next 24 hours, press: h [More functions] > [System] >

[Tools] [Tools] > [Software [Sof tware shutdown]

Switch off the instrument.

Longer than 24 hours If the instrument will be shut down for longer than 24 hours, perform the following f ollowing procedure. Before shutting down the instrument, backup the data to a PCMCIA card or an interface. e

See Chapter 8 Operating modes, section Database > Data export – PCMCIA card (for example) on page B-55

Roche Diagnostics recommends decontaminating decontaminating all surfaces and tubing before shutting down the instrument. e

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

While in the "Analyzer" operating mode, press: h [More functions] > [System] >

[Tools] [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.



cobas b 121 system

3 Installation and shutdown 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 t he guide. B

A

A

A

Ventilation tube V9

B

air mixture valve tube V2


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

A A

A

End of the tubes

Figure 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.

June 2008 A-37


cobas b 121 system

Shutdown


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

1

Remove the shutdown kit.

4. Remove the shutdown kit

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. 2

Start the procedure for emptying the tubes t ubes 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 Figure A-35 A-35). B

A

A

A

Ventilation tube

B

Air mixture valve tube



Close the docking mechanisms. June 2008 Instructions for Use · Version 10.0

cobas b 121 system


7. Remove the pump tube 1

Open the instrument cover. cover.

2

Open the peristaltic pump's clear plastic plasti c cover (tension lever). Push the linear clamp (white plastic piece) upwards (see Figure Figure A-36 A-36).

3

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

A

B C

A

Tension leve r

B

Pump head

C

Linear clamp


Close the tension lever le ver (clear plastic cover).

1

Open the measuring chamber cover.

2

Open the locking lever. lever.

8. Remove the electrodes

A A

Locking lever

B



3

Remove the electrodes.

4

Close the locking lever l ever and the measurement chamber cover. cover.

June 2008 A-39


cobas b 121 system

Shutdown

9. Remove needle and fill port 1


2

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

Do not bend the needle!

3

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

( 1)

( 2)

(3)


Close the flap.

1


2

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

3

Close the printer cover. cover.

10. Remove the printer paper



cobas b 121 system


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.

B

A A

Feed tube C1 solution

B

feed tube: C2 solution


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 positio n.

3

Close all covers.

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.


4

Switch the instrument OFF.

5

Shut down is complete.

June 2008 A-41


cobas b 121 system

Shutdown

13. Uninstall the AutoQC module 1

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

A A

Unlocking knob


Remove both tube ends in the bottle compartment from the docking por t.

A A

A

Tube ends

B



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


cobas b 121 system


4

Insert the red plastic relief clamp for the t he AutoQC valve V17.

A A

Relief clamp for the AutoQC valve V17


If you plan to transport the instrument, be sure to unplug the power p ower cord, the scanner, scanner, and the network cable. Then install instal l the transport safety saf ety device for the t he AutoQC module.

A A

Transport safety band



Use the original packaging when transporting the i nstrument!

June 2008 A-43


cobas b 121 system

Shutdown



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.

In this chapter

Chapter

4

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 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


June 2008 A-45

4 Specifications

cobas b 121 system

Table of contents



cobas b 121 system

4 Specifications Performance data

Performance data Measured parameters specified

Precision(a) (b)

Precision (a) (b)

(within-run)

(day-day)

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 (8% - 3.013 kPa)

< ± (12% - 4.586 kPa)

0 - < 60 mmHg

SD < (10.7 - 12%) mmHg

SD < (12.2 - 12%) mmHg < ± (16.8 - 13%) mmHg

60 - 200 mmHg

SD < 3.5 mmHg

SD < 5.0 mmHg

± 9.0 mmHg

> 200 - 800 mmHg

SD < (7% - 10.5) mmHg

SD < (7% - 9.0) mm mmHg

< ± (6..5% - 4) mmHg

0 -< 7.998 kPa

SD < (1.426 - 12%) kPa

SD < (1.626 - 12%) kPa

< ± (2.239 - 13%) kPa

7.998 - 26.660 kPa

SD < 0.467 kPa

SD < 0.667 kPa

± 1.200 kPa

26.660 - 106.640 kPa

SD < (7% - 1.400) kPa

SD < (7% - 1.200) kPa

< ± (6.5% - 0.533) kPa

4 - < 15 mmHg

SD < 2 mmHg

SD < 3 mmHg

± 4 mmHg

15 - 80 mmHg

SD < 1.5 mmHg

SD < 2.0 mmHg

± 2.5 mmHg

> 80 - 200 mmHg

SD < 4.5 mmHg

SD < 6 mmHg

± 8 mmHg

0.533 - < 2.00 kPa

SD < 0.267 kPa

SD < 0.400 kPa

± 0.533 kPa

2.00 - 10.664 kPa

SD < 0.200 kPa

SD < 0.267 kPa

± 0.333 kPa

10.664 - 26.660 kPa

SD < 0.600 kPa

SD < 0.800 kPa

± 1.066 kPa

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

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

SD < 0.15 mmol/L

SD < 0.35 mmol/L

± 0.5 mmol/L

3.0 - 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

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

Specified range

for P O2

B

Q

P CO CO2

pH

+

Na

+

K

Cl-

B/Q

B/Q

B/S/A/D/Q 20 - < 120 mmol/L

B/S/A/D/Q 0.2 - < 3.0 mmol/L

B/S/A/D/Q 20 - < 70 mmol/L

Accuracy(a)

Table Table A-1


June 2008 A-47

4 Specifications

cobas b 121 system

Performance data

Precision(a) (b)

Precision (a) (b)

for

(within-run)

(day-day)

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

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

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)

<± (7.1% - 0.78 g/dL)

30.00 - < 60.00 g/L

SD < (3.0% + 2.70 g/L)

SD < (3.3% + 3.00 g/L)

< ± (-3.3% + 7.00 g/L)

60.00 - 180.00 g/L

SD < 4.50 g/L

SD < 5.00 g/L

< ± 5.00 g/L

> 180.00 - 250.00 g/ g/L

SD < (2 (2.1% + 0.60 g/L)

SD < (2.1% + 1. 1.10 g/L)

<± (7.1% - 7. 7.80 g/ g/L)

1.8 .86 6 - < 3. 3.772 mm mmol/L l/L

SD < (3. (3.0% 0% + 0.1 0.17 7 mm mmol/L) l/L) SD < (3.3%+0.19 mmol/L) <±(-3.3%+0.43 mmol/L)

3.72 - 11.16 mmol/L

SD < 0.28 mmol/L

> 11. 11.16 16-1 -15. 5.51 51 mmol mmol/L /L

SD < (2. (2.1% 1% + 0. 0.04 04 mmol mmol/L /L)) SD < (2.1%+0.07 mmol/L) <± (7.1%-0.48 mmol/L)

3 - < 12 g/dL

SD < 0.36 g/dL

SD < 0.40 g/dL

< ± 0.36 g/dL

12 - 25 g/dL

SD < 3.0%

SD < 3.3%

< ± 3.0%

30.00 - < 120.00 g/L

SD < 3.60 g/L

SD < 4.00 g/L

< ± 3.60 g/L

120.00 - 250.00 g/L

SD < 3.0%

SD < 3.3%

< ± 3.0%

1.86 - < 7.4 4 mmol/L

SD < 0.22 mmol/L

SD < 0.25 mmol/L

< ± 0.22 mmol/L

7.44 - 15.51 mmol/L

SD < 3.0%

SD < 3.3%

< ± 3.0%

50 - < 60%

SD < (-5.0% + 4.0 %)

---------------------------- < ± (-20% + 14%)

60 - 100%

SD < 1.0%

----------------------------

< ± 2.0%

50 - 100%

SD < 1.0%

SD < 1.1%

< ± 2.0%

300 - 800 mm mmHg

----------------------------

---------------------------- < 55..0 m mm mHg

39.9 39.990 90 - 106 106.6 .640 40 kPa kPa

-------------------------------------------

------------------------------------------- 0. 0.66 667 7 kP kPa

specified Ca2+

Hct

tHb

B/Q

B

Q

S O2

B Q

Baro(c)

Specified range

Accuracy(a)

SD < 0.31 mmol/L

< ± 0.31 mmol/L

Table Table A-1 (a) Accuracy Accuracy and standard deviations: deviations: specified for the standard temperature temperature range range of 15 - 31 °C! (b) According According to CLSI CLSI within the the specific range range (c) When used within the range of 300...450 300...450 mmHg, the barosensor barosensor must be calibrated by technical technical support before initial start up!

B....whole blood

A....dialysis solutions containing acetate

Q... ....aqu .aqueo eous us QC mate aterial rial

D.. ....dial dialyysis sis solu soluti tio ons contai tainin ning bic bicarbo arbon nate ate


S...serum or plasma


cobas b 121 system

4 Specifications Default and input values

Default and input values Parameter tHb

50 Adult P 50

Default values

Range (default values)

Range (input values)

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

26.7 mmHg

not editable

not editable

not editable

not editable

3.56 kPa 50 P 50

Fetal

21.5 mmHg 2.87 kPa

F IO IO2

0.21

0.1 - 1.0

0.1 - 1.0

R

0.84

0.7 - 2.0

0.7 - 2.0

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

Patient temperature

Table Table A-2

Sample throughput Activated / installed installed

Typical Typical sample throughput throughput

electrodes

[samples / hours] Syringe

Capillary

BG - tHb/SO2

30

30

BG - ISE - tHb/SO2

30

30

Table Table A-3

Sample volume If the sample contains a higher Hct concentration, a sample volume of up to 70 µL is required! Activated / installed installed electrodes electrodes

Typical Typical sample volume (a)

[µL]

Typical Typical specimen volume

Typical Typical specimen volume

(capillary position)

(syringe position)

(b)

[µL]

BG - ISE - tHb/SO2

60 60

68

[µL](c)

90

(a) (a) typical typical for Hct ≤ 45% (b) Volume limitation through through sample sensor: If the specified volume is reached, an aspiration stop occurs occurs (approx. 1 second). second). If the capillary is not removed, the aspiration process continues. (c) No aspiratio aspiration n stop in the syringe syringe position. position.


June 2008 A-49

4 Specifications

cobas b 121 system

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)

< 25

Warm-up phase

power fail < 1 minute

<2

as needed

< 27

Electrode exchange Table Table A-4 (a) incl. incl. calibra calibratio tion n



cobas b 121 system

4 Specifications Environmental parameters

Environmental parameters Temper Temperature ature / humidity humidity / stability Instrument Operating conditions o

Ambient temperature

+15 °C to +33 °C

o

Ambie bient air pressur sure

462 - 800 mmHg (61.63 - 106.60 .60 kPa) (a)

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

o

< +33

°C

Measu Measure remen mentt chamber chamber temp temp.. 37°C 37°C ± 0.2 °C

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

Storage and transportation conditions o

Temperature

-20°C to 50 °C

o

Humidity

to 95% (not condensed)

o

Shock resistance

< 30 g

Electrodes Operating conditions o

Ambient temperature

+15 °C to +33 °C

o

Measurem Measurement ent chamber chamber temp. temp. +37 °C ± 0,2 °C

o

Relative humidity

20 - 95%, if T > +15 °C to ≤ +31 °C 20 - 90%, if T > +31 °C to

< +33

°C

Storage conditions in original packaging o

Temperature

+15 °C to +30 °C

o

Humidity

20 to 85% (not condensed)

Transportation Transportation conditions in original packaging

Roche Diagnostics Instructions for Use · Version Version 10.0

o

Temperatur

+2 °C to +30 °C

o

Humidity

20 to 80 % (not condensed) over a period of 3 days

o

Shock resistance

< 50 g

June 200 8 A-51

4 Specifications

cobas b 121 system

Environmental parameters

Solutions 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

< +33

°C

Storage conditions in original packaging o

Temperature

+2 °C to +30 °C (24 months (a))

o

Relative humidity

20 to 95%

(a) storage time contains transportation time and the storage storage from delivery from the the factory!

Transportation Transportation conditions in original packaging o

Temperatur

+2 °C to +45 °C over a period of 7 days

o

Relative humidity

20 - 95%

o

Shock resistance

< 30 g

Stability during operation Solutions

Description

With ambient temperature of +15 °C to +33 °C [weeks]

o

C1 Calibr Calibrati ation on Solutio Solution n 1 Calibra Calibration tion Solution

min. 4 up to 6 (depending on the remaining volume)

o

C2 Calibr Calibrati ation on Solutio Solution n 2 Calibra Calibration tion Solution

min. 4 up to 6 (depending on the remaining volume)

o

C3 Fluid Pack

Solution pack

8

QC material Storage conditions in original packaging o

COMBITROL TS+

up to 3 months at +2°C to +28 °C

o

AUTO-TROL TS+

up to 2 months at +2°C to +28 °C

o

COMBITROL TS+

up to 24 months at 2°C to 8 °C

o

AUTO-TROL TS+

up to 24 months at 2°C to 8 °C

or

Transportation Transportation conditions in original packaging o

COMBITROL TS+

0 °C to +30 °C over a period of 5 days

o

AUTO-TROL TS+

0 °C to +30 °C over a period of 5 days

Stability during operation o


AUTO-TROL TS+

28 days (wit with ambient temperature of +15 °C to +33 °C)

June 200 8 Instructions for Use · Version Version 10.0

cobas b 121 system

4 Specifications Product data

Product data Electrical data Mains voltage range:

100 to 240 VAC (±10% permissible tolerance)

Frequency:

50/60 Hz

Required power:

150 W

Classification (according IEC/ISO) Protection class:

I

Over voltage categor y:

II

Contamination level:

2

Width:

35.4 cm

Heigth:

46.7 cm

Depth:

41.0 cm

Width:

19.5 cm

Heigth closed:

19.8 cm (open: 38.7 cm)

Depth:

39.5 cm

Dimensions Instrument

AutoQC-Modul AutoQC-Modul

Weight coba cobass b 121 system (instrument):

about 17 kg (without calibration solutions)

system ready ready for shipment: shipment: about 23 kg coba cobass b 121 system AutoQC module:

5.9 kg (without ampoule mats)

Printer


Type:

t hermal 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

June 2008 A-53

4 Specifications

cobas b 121 system

Screen

Screen 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 mm

Reading distance:

up to 5 cm

Reading width:

up to 8 cm

Preprogrammed code types (a):

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

Barcode scanner

(a) Further available available barcode types can be programmed programmed in accordance accordance with the enclosed enclosed manual manual of the PS2 hand-held scanner (included in scope of delivery).



Operation

B

5

Mea easu sure reme ment nt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 B-3

6

Qual Quality ity contr control ol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-15 B-15

7

Cali Calibr brati ation on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-35 B-35

8

Opera Operatin tingg mode modess . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-41 B-41

June 2008

cobas b 121 system

5 Measurement Table of contents

Measurement

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

In this chapter

Chapter

5

Preanalytics ................................................................... .................................. ................................................................ ............................................... ................ B-5 Sample collection ............................................................. ............................. ................................................................ ..................................... ..... B-5 Sample acquisition ........................................................... ............................ .............................................................. ............................... B-5 Acceptable anticoagulants ........................................................ ........................... .................................................... ....................... B-5 Sample collection especially for tHb, SO2 and Hct measurement 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 measurement report ........................................................ ........................... ..................................... ........ B-13


June 2008 B-3

5 Measurement

cobas b 121 system

Table of contents

Roche Diagnostics B-4


cobas b 121 system

5 Measurement Preanalytics

Preanalytics Sample collection Follow the usual applicable safety precautions when drawing blood s amples. 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 s ampling techniques in order to reduce risk to personnel. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necess ary 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. e

Please refer to CLSI document M29-A3, "Protection of Laboratory Workers from occupationally acquired infections." Approved Approved guidelines - Third Edition 2005.

Sample acquisition Only qualified personnel may perform the collection of blo od needed for analytical purposes. The puncture site may never be squeezed! Mixing the blood s ample 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. 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 anticoa gulants cobass b 121 system The only clot inhibitors that may be used for analyses in the coba system are heparin salts. Other clot inhibitors, such as EDTA, citrate, oxalate, fluoride, and ammonium-based materials have significant influence on the blood's pH and other parameters 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 red blood cells and plasma before insertion of the sample. Carefully rotate the sample about two axes using your hand or a mechanical device or insert a metal disk or ball in the syringe before collecting the sample. Shortly before using the sample, carefully shake the syringe. The up and down motion of the disk or ball inside the syringe cylinder ensures consistent mixing. e


Refer to CLSI document C46-A "Blood gas an pH analysis related measurements; Approved Guideline 2001".

June 2008 B-5

5 Measurement

cobas b 121 system

Preanalytics

Sample collection containers When possible, use the sample collection systems recommended by Roche Diagnostics.

Syringes If using another manufacturer's product with liquid heparin as a clot inhibitor, the collection container should not be larger than required for the blo od volume. This will minimize the effects of the clot inhibitor on the thinning of the blood. The use of plastic syringes is common, but there are cases when the use of plastic syringes is not appropriate, for example, when P O2 values are expected to be outside the normal range. If very high P O2 values are expected, the sample should be analyzed as quickly as possible after the specimen collection. Use only heparinized syringes. Improper use of syringes with liquid heparin will affect the parameters, especially the ISE parameters!

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 that forms when opening the capillary can damage the fill port of the instrument. Use only capillary tubes with w ith heat-treated ends to avoid damage to the instrument. When using stirring rods like those offered by a few manufacturers, remove these rods before inserting the sample in order to avoid clogging the instrument. Roche MICROSAMPLER® The Roche MICROSAMPLER, which consists consists of two capillary capillar y tubes (115 μL each) in a plastic container, is ideally suited to atraumatic arterial blood collection. Each laboratory should document the permissibility permissibil ity of sample containers that are used. These products vary from f rom manufacturer to manufacturer and sometimes from lot to lot. The use of sample containers or clot inhibitors other than those manufactured by Roche Diagnostics may lead to adulteration of the samples and errors and differences in the measurement values. Roche developed a specialized sample collection container for this purpose and recommends its use for this reason.

Clot catcher The use of a clot catcher is recommended recommended to prevent clogging of the sample path during measurement of critical blood, for example, when sampling blood of newborns, blood from ear lobes, and blood from heels. The clot catcher prevents blood clots and tissue part icles from entering the instrument. The clot catcher cannot be used in "Syringe mode" and not be connected in "Capillary "Capillary mode". mode". ATTENTION


The capillary with attached clot catcher must be held in position!


cobas b 121 system

5 Measurement Preanalytics

Sample handling Whole blood Withdraw whole blood samples using heparinized syringes, capillaries, or the Roche MICROSAMPLER. Analyze the samples as soon as possible after after sampling. Remove air bubbles from the sample collection container immediately after the sampling procedure. Immediately after withdrawing the sample with syri nges, thoroughly mix the sample with anticoagulant. This can be done by rolling the sample between both hands or shaking. Properly label the samples, following the standard do cumentation procedure. o

Samples that are measured within 15 minutes may be retained at room temperature.

o

If unable to measure samples within 15 minutes, place them temporarily in ice water. water. Complete the measurement within 30 minutes (but not after more than 60 minutes).

o

Samples with a P O2 level above 200 mmHg (26 kPa) should be collected in i n a glass container if the measurement can not be performed within 15 minutes.

When using capillaries analyze samples for tHb, S O2 O2 and Hct measurements immediately after sampling to ensure correct and accurate measurement results.

Despite proper sampling procedures, errors can arise in the blood gas analysis: o

due to insufficient mixing of the sample following removal and before the measurement

o

due to ambient air contamination caused by air bubbles that are not removed following removal of the sample

o

due to changes in metabolism in the sample

Serum After the appearance of spontaneous clotting, process the sample i n a centrifuge to separate the cellular, solid components and the fibrin from t he watery serum. Transfer the serum to a suitable sample container and seal. If it is necessary to store the sample, close the sample container tightly and cool it to 4 - 8 °C. If a sample has been cooled, warm it to room temperature (15 - 33 °C) before analysis. Plasma Plasma samples are obtained by centrifuging heparinized whole blood, during which the cellular components of the blood are removed from plasma. Complete the analysis as quickly as possible. If it is necessary to store the sample, close the sample container tightly and cool it to 4 - 8 °C. If a sample has been cooled, warm it to room temperature (15 - 33 °C) before analysis. Plasma samples older than 1 hour must be re-centrifuged in order to remove fibrin clumps that may have formed.


June 2008 B-7

5 Measurement

cobas b 121 system

Measuring procedure

Measuring procedure QC measurements must be performed in their entirety (i.e., all three QC levels must be measured). Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health. e

For detailed information, see Chapter 6 Quality control !

In order to start a measurement, the instrument must be "Ready" and in the "Analyzer" operating mode. Depending on the settings, the entry of a password or a mandatory input (value) may be required. e

A

Password protection active

See Reference Manual , chapter Setup!

B

Mandatory input

C

"Ready" - without another function like password, etc.

Figure Figure B-1

You have the option of measuring samples from syringes (without needles), ampoules and capillaries.



cobas b 121 system

5 Measurement Measuring procedure

Syringe mode Improper heparinization of syringes with liquid heparin may cause false results. ISE parameters are particularly susceptible. 1

Open the flap to the designated syringe position (half-opened position). The aspiration process is started.

Figur Figure e B-2 2

Attach the syringe (always remove the cannula first). Be sure that the needle sufficiently penetrates the interior of the syringe (or ampoule) in order to remove the sample without air bubbles.

Be sure that the needle does not make contact with the fill port while inserting the needle into the interior of the syringe. WARNING

If the opening of the needle is covered by the fill port, the aspiration is blocked and the sample is rejected! If using an ampoule instead of a syringe (during a QC measurement), be sure that the ampoule does not make contact with the fill port when inserting the needle into the ampoule. The sharp edge can cause damage to the fill port. The clot catcher cannot be used in "Syringe mode".

Figur Figure e B-3


June 2008 B-9

5 Measurement

cobas b 121 system

Measuring procedure

3

The sample is automatically aspirated (it is unnecessary to press any buttons).


Upon display of the instruction "Close flap", remove the syringe and close the flap.

5

The measurement starts.

Never open the flap during measurement. Doing this will result in rejection of the sample!

Capillary mode 1

Open the flap to the labelled capillary position (completely open position). The aspiration process is started.

Open the flap slowly to avoid splattering small drops of liquid that are on the needle tip.

Figur Figure e B-5



cobas b 121 system


2

Insert the capillaries or the Roche MICROSAMPLER into the fill port.

The end of the capillary must be open, otherwise the aspiration process is blocked and the sample is rejected. WARNING

The capillary with attached clot catcher must be held in position! Never inject the sample into the instrument! Danger of infection!


The sample is aspirated automatically into the analyzer.


Upon display of the instruction "Close flap", remove the capillary and close the flap.

5

The measurement starts.

Never open the flap during measurement. Doing this will result in rejection of the sample!


June 2008 B-11

5 Measurement

cobas b 121 system

Measuring procedure

Data input During measurement, various patient, operator, and sample-specific data may be entered. You You may use a standardized or a user-specific form for m when entering data. Scanning of patient and operator dat a is possible! The user must carry out a plausibility check for all barcode data read in and displayed by the instrument!

You can create a user-specific form that contains the desired parameters by selecting selecti ng h [Setup] > [Displays & e

reports] > [Measuring data] > [Input values]

See Reference Manual , Chapter Setup!

Press the [More functions] button to select the predefined form. This form remains the standard until a new form is selected. A

A

More functions

Figure Figure B-8

Use the [line up] / [line down] buttons to select the entry that you would like to modify or use your finger to select the appropriate line directly. By pressing these buttons, you can complete the following steps: Input data Edit the underlying entry Go to additional views Start a printout



cobas b 121 system


Results display / measurement report After the measurement is complete and all parameters have been entered, the instrument displays the results on a standardized or user-specific form on the screen before printing the results. Use the menu selection h [Setup] > [Displays &

reports] > [Measuring data] > [Result screen]

to create a user-specific results display. display. e

See Reference Manual, Chapter Setup!

Press these buttons to select a predefined form. >

This remains the standard until a new form is selected. Create a user-specific measurement report by selecti ng h [Setup] > [Displays & e

reports] > [Measuring data] > [Measurement report]

See Reference Manual, Chapter Setup!

Press these buttons to select a predefined report. >

This remains the standard until a new report is selected.

Figure Figure B-9

Subsequent correction of the input parameters is possible by pushing this button, even after ending the measurement, as long as the measurement results are still visible on the screen. The results are entered automatically into the database. Change to the "Database" operating mode in order to view the database entry. Additional entries can be completed or edited i n the database. e


For more information, refer to Chapter 8 Operating modes, section Database in these Instructions for Use and to the respectively titled chapters in the Reference Manual!

June 2008 B-13

5 Measurement

cobas b 121 system

Measuring procedure



cobas b 121 system

6 Quality control Table of contents

Quality control

For safety reasons, quality control measurements must be carried out on a daily basis. In this chapter, all steps are described that are necessary for a successful QC measurement.

In this chapter

Chapter

6

Quality control - general ............................................................................ ............................................... ............................................ ............... B-17 General QC concept .................................................................................... ...................................................... ............................................ .............. B-17 Important information concerning concerning the analysis of QC QC measurement results results ....... B-19 Material setup ............................................................... ............................... .............................................................. ............................................. ............... B-20 Inserting AutoQC mats ................................................................. ................................... .................................................... ...................... B-21 Material assignment - AutoQC materials .......................................................... ........................... ............................... B-22 [New mat] ............................................................. ............................. .............................................................. ......................................... ........... B-22 AutoQC mat detail screen ................................................................ ................................... .......................................... ............. B-22 Setting QC times .............................................. ............... ............................................................ ................................................... ...................... B-23 Setting start time(s) .................................................................................. ................................................... .................................... ..... B-24 Copying a time entry ......................................................................... ......................................... ............................................ ............ B-24 Measurement Measurement retries .............................................................. ............................ .......................................................... ........................ B-25 QC measurement ............................................................ .......................... ................................................................ .......................................... ............ B-26 Manual QC measurement ............................................................ .......................... ......................................................... ....................... B-26 AutoQC measurement ........................................................................................ ....................................................... ................................. B-27 Multirules .............................................................. ............................. ................................................................ .................................................... ..................... B-28 Overview of the Multirules ........................................................ ........................... ...................................................... ......................... B-29 QC consequences consequences ........................................................................ ....................................... ............................................................... .............................. B-30 QC unlock ................................................................ ............................... ................................................................ .................................................. ................... B-31 QC warning ............................................................ ............................ .............................................................. ............................................. ............... B-31 QC error .............................................................. .............................. .............................................................. ................................................. ................... B-31 Automatic lockout reversal ......................................................... ........................... ................................................ .................. B-31 Manual lockout reversal .............................................................................. .............................................. .................................... B-31 Exchange the electrode ........................................................................ ............................................ ...................................... .......... B-31 QC troubleshooting ............................................................. ............................. ................................................................ ..................................... ..... B-32 Description of the current current problem ................................. . ................................................................ .................................... B-32 Classification of of QC problems ............................................................................ .............................................. .............................. B-32 Roche Diagnostics Instructions for Use · Version 10.0

June 2008 B-15

6 Quality control

cobas b 121 system

Table of contents

Group A ........................................................... ........................... ............................................................. .............................................. ................. B-32 Group B ............................................................. ............................. .............................................................. ............................................. ............... B-32 Troubleshooting – Group Group A (aspirating or positioning problem) ................... B-32 Troubleshooting – Group B (QC result exceeds the target value range) .......... B-33



cobas b 121 system

6 Quality control Quality control - general

Quality control - general QC measurements must be performed in their entirety (i.e., all three QC levels must be measured). Omitting QC measurements or ignoring QC measurement results may lead to incorrect patient measurements, which may result in incorrect clinical decisions, possibly endangering the patient's health.

WARNING

General QC concept Roche Diagnostics always strives to ensure the highest quality standards for it s products. This quality awareness is the result of a sense of responsibility toward the customer and the well-being of the patient. The quality control is an important import ant element of this claim. Aqueous blood gas/ electrolyte QC materials, such as COMBITROL TS+, AUTO-TROL AUTO-TROL TS+, etc., are offered to ensure that the instrument provides measurements of high quality to protect customers or their patients. 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 exchange of solutions and packs and after startup of the instrument. Additionally complete a quality control test on one le vel between two automatic 2P calibrations. The levels have to be alternated (low, (low, normal, high). For example (2P calibration interval: 12 hours):

24 hours

--------

2P-Cal.

Level 1

2P-Cal.

Level 2

2P-Cal.

Level 3

2P-Cal.

Level 1

Figure Figure B-10 B-10 NOTE

The automatic system calibration includes a complete 2P calibration.

Complete at least two quality control tests on dif ferent levels once daily or more often in accordance with local regulations. Run quality control tests ideally prior to s ample measurements.

A quality control program includes the analysis of sample materials with known ranges of expected values and the comparison of these values with analyzer results.


June 2008 B-17

6 Quality control

cobas b 121 system

General QC concept

The following control material is recommended: o

COMBITROL TS+

o

AUTO-TROL TS+ (AutoQC material)

The target areas listed in the package text should be taken as 2SD areas (SD = standard deviation) (e.g. for P O2, 2SD = 12 mmHg, 1SD = 6 mmHg). The QC measurement results within the target value range ± 2SD are acceptable. If QC measurement results fall outside the target value range ± 3SD, the parameter must be locked! QC measurement results that are greater than the target value ± 2SD, but less than the target value ± 3SD, cause QC warning and must be treated accordingly .



cobas b 121 system

6 Quality control Important information concerning the analysis of QC measurement results

Important information concerning the analysis of QC measurement results Ensure (specifically for software versions earlier than 1.31!), that "Multirules" rule 1 and 2 are activated and the QC consequence "QC error" was assigned to the parameters. WARNING

With software version 1.31 and later, a Multirule violation automatically generates a parameter lockout, as long as the default settings were not changed. e

See section Multirules on page B-28! B-28!

e

See section QC consequences on page B-30! B-30!

The evaluation depends upon which SD areas are featured in t he QC measurement results: o

Measured value is within the target value range ± 2SD

The parameter is acceptable. The QC measurement results are within ± 2SD from the target value and the parameter is/remains activated for measurements. o

Measured value is outside the target value range ± 3SD

Consequence: A "QC Error" is assigned to the parameter. The QC measurement result is not acceptable. The parameter is locked for additional measurements and may only be released for further patient measurements, after the cause of the lockout has been determined and the er ror has been corrected e

o

See section QC unlock on page B-31! B-31!

Measured value is larger than target value ± 2SD, but less than target value ± 3SD

Consequence: A "QC Warning" is assigned to the parameter. The user must now analyze the QC measurement results in accordance with applicable regulations or repeat the measurement. Call up the QC statistics in the QC database to aid in the analysis. e

See Chapter 8 Operating modes, section QC data on page B-58! B-58!

The analysis can be automated by activating additional multir ules e

See section Multirules on page B-28! B-28!

If a second measurement is greater than target value ± 2SD, but less than target value ± 3SD, the parameter is not locked, but must not be used for further pat ient measurements.

To eliminate the error, replace the electrode and/or contact technical support. WARNING


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6 Quality control

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Material setup

Material setup Take the lot number, expiration date, sample type, and t arget values (ranges) as well as the corresponding barcodes from the text included in the recommended QC material.

The QC material must be defined prior to the QC measurement. The barcode scanner facilitates easy entry of the required information. Press the following buttons: h [Setup]

> [QC materials] > [Set ranges]

Up to 4 different QC materials with 4 levels each can be entered.

Figure Figure B-11

Use the [line up] / [line down] button to select the material to be changed or to select a new "QC "QC material". material". Using the barcode scanner to enter data

Use the barcode scanner to enter the material code found on the packaging insert. The material code contains the information for the material, the proper level, lot number, number, expiration date, and sample ty pe. Scan in two barcodes (the BG and tHb/SO2 code and the ISE code) for the set ranges. The instrument automatically assigns these.

Manual entry

Use the [Data input] button to manually enter lot number, number, expiration date, sample type and target values. Complete and save the entry by pressing this button twice.



cobas b 121 system

6 Quality control Material setup

Inserting AutoQC mats Insert the mats as follows in the t he ampoule block: 1

Open the cover of the AutoQC module.

2

Take a full mat (20 ampoules) from the package.

3

To mix the QC material, turn tur n the mat twice so that the ampoules point up. Next, insert the mats in the ampoule block with the ampoule necks pointing down (see Figur Figuree B-12 B-12/1).

B

A

A

AutoQC ampoule block

B

Inserted mats

(1)

(2)

Figure Figure B-12 4

Place the mat in the assigned position (A-F). When fully inserted only the rubber mat will be seen, the glass ampoules will no longer be visible (see Figure Figure B-12 B-12/2).

5

Repeat the same process for all additional mats.

6

Close the cover of the t he AutoQC module.

If only 3 full ampoules are left in a mat for a QC material, it is labeled as used.


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6 Quality control

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Material setup

Material assignment - AutoQC materials Before beginning an AutoQC measurement, the selected AutoQC material must b e assigned.


Use the [line up] / [line down] buttons to select the mat to be defined (A-F).

2

The selected material/level combination is assigned to this mat location by pressing [Material].

[New mat] An existing and defined mat is replaced by a new one from the same batch (e.g. in case of insufficient or empty ampoules). The number of ampoules is reset to 20. The selected material can be deleted from f rom the mat position.

The preprogrammed times must be deleted before the material is deleted. e

See section Setting QC times on page B-23! B-23!

AutoQC mat detail screen Press the button [Details] to display the following fol lowing details:

Figure Figure B-14 B-14

This screen shows detailed information about the AutoQC material placed on this mat. Roche Diagnostics B-22


cobas b 121 system


Press the [Details] button again to change to the mat assignment screen.

Figure Figure B-15

This screen shows the assignment of the selected mat. corresponds to a full ampoule corresponds to an empty ampoule The assignment of the mat can be freely defined by selecting or deselecting individual ampoules. The AutoQC cover must be open for this purpose.

Setting QC times Depending on the selected material, this function is used to select the start t ime(s) for the AutoQC measurement(s) measurement(s) and/or the time for performing a manual QC measurement. After reaching the set time, a note appears in the message window.


Up to 16 time entries per day can be made to initiate when an AutoQC measurement should be started. Up to 6 materials (= 6 mats for the AutoQC) can be specified for each time. A little marker (small magenta-colored triangles) on the time scale indicates the defined start time(s). Roche Diagnostics Instructions for Use · Version 10.0

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6 Quality control

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Material setup

Setting start time(s) Select the day from the "Day of Week" list on which the QC measurement should be performed. Add a new time entry / remove it again. The following screen appears (for example):

Figure Figure B-17 B-17 1

Select the material/level combination from the list (this list contains all material/ level combinations that were created under [Setup] > [QC Material] > [AutoQC Material] or [Setup] > [QC Material] > [Set ranges]).

2

Confirm the selection.

3

Enter the start time. Any number of materials and times can be selected.

4

Press this button.

5

The attributes of the time entries can be edited

Copying a time entry Select a day of the week and a time entry and press – the selected time entry of this weekday will be copied. Select another day of the week and press – the copied time entry will be entered for the new weekday. These entries can be transferred to as many other weekdays as required.



cobas b 121 system


Press [More functions]:

Measurement retries The number of repeated measurements (none=0, 1, 2) that are allowed in the case of an incorrect measurement can be adjusted here. A faulty measurement is present if the measurement lies outside the display range or no measurements can be output due to a suction fault.


The measurement repetition is automatically started in case of a faulty measurement.


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6 Quality control

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QC measurement

QC measurement 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 exchange of solutions and packs and after startup of the instrument. Additionally complete a quality control test on one le vel between two automatic 2P calibrations. The levels have to be alternated (low, normal, high) e

See section General QC concept on on page B-17! B-17!

Manual QC measurement Make sure, that the ampoules do not come directly out of the refrigerator or from a hot spot. They should rest for approximately 24 hours to slowly adapt to room temperature (25° C, 77° F).

Press the following buttons: h [More functions] > [QC

measurement]

1

Activate the corresponding QC material (for example, COMBITROL TS+) and the selected level (for example, level 1).

2

Remove the ampoule of the corresponding level of the desired QC material from the packaging or of the AutoQC material from the mat.

3

Mix the content well by gently swaying the ampoule with a rotating movement (do not shake it).

4

Gently tap the head of the ampoule with your fingernail to remove any liquid from the top.

5

Break open the ampoule.

To avoid injury, protect your hands with gloves and tissues when breaking open the ampoule. GEFAHR

Use the control material within 30 seconds of opening. Never reuse the ampoule! 6

Open the flap to the designated syringe position (half-opened position).

Figure Figure B-19



cobas b 121 system

6 Quality control QC measurement

Suction the QC material directly from the ampoule! 7

Insert the needle into the ampoule. The needle should be inserted deep enough into the fluid to avoid air bubbles.

Figure Figure B-20

When inserting the needle into the ampoule, it is absolutely necessary to avoid contact between the ampoule and the filling port. The sharp edge can cause damage to the fill port. 8

The aspiration process ist started.


Remove the ampoule and close the flap.

10

The measurement starts automatically. automatically.

11

If the user does not reject the results, they are printed and automatically saved in the QC database.

e

Details about the operating mode see Chapter 8 Operating modes section Database > QC data and in the Reference manual !

AutoQC measurement The AutoQC measurement measurement can be performed in programmed or manual mode. To start measurement of the control material, activate the corresponding AutoQC material (AUTO-TROL (AUTO-TROL TS) and the selected level (e.g. level 1). Start the AutoQC measurement measurement by pressing [AutoQC]. Roche Diagnostics Instructions for Use · Version 10.0

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6 Quality control

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Multirules

Multirules The evaluation of QC results is based on the Westgard(a) rules and their interpretation for blood gas analysis(b). The Multirule process was derived from these rules. It permits early detection of random r andom and systematic errors associated with the measuring device and its operation. The Multirules procedure can only be applied in connection with a suitable control material (e.g. COMB ITROL TS+, AUTO-TROL AUTO-TROL TS+). ATTENTION

The Multirule procedures produce the best results when 3 QC measurements with randomly selected levels are completed per series (time between two 2-point calibrations). A minimum of 2 QC measurements / series or 6 QC measurements / 3 series is requir required. ed. The QC concept expects Multirules rule 1 and 2 to be activated. Press the following buttons to check the settings: h [Setup] > [Parameters] > [Miscellaneous settings] >

[Multirules]

Figure Figure B-22

Select additional desired rules in the left window and assign it to the corresponding parameter which is listed in the right window under "Parameters". "Parameters". NOTE

It is not possible to activate all rules at the same time!

The activation of range 2SD automatically deactivates all other rules (rules 1-6).

(a) James O. O. Westgard, Westgard, et al: A Multi-Rule Shewhart Chart for Quality Control Control in Clinical Chemistry. Clinical Chemistry, Vol. 27, No.3, 1981 (b) Elsa F. F. Quam BS, Lorene K. Haessig BS, Marlene Marlene J. Koch BS: A Comprehensiv Comprehensivee Statistical Quality Control Program for Blood Gas Analyzers. Journal of Medical Technology 2:1 January 1985 Roche Diagnostics B-28


cobas b 121 system

6 Quality control Multirules

Overview of the Multirules Run

time between two 2-point calibrations

N T

number of individual measurements of all levels ( T=total)

NL

number of individual measurements per level (L=Level)

m

QC measurement value of one level and one parameter

x

mean value, taken from the insert sheet or calculated based on at least 20 and no more than 100 individual measurements

σ

standard deviation

Rule

Description

1. 12σ

QC measurement value (m) is outside x ± 2σ

2. 13σ

QC measurement value (m) is outside x ± 3σ

3. (2 von 3)2σ

Two of three QC measurement values are outside x ± 2σ Observation time period: 1 series (within run) NT = 3

4. 22σ

2 QC measurement values (m) are outside x ± 2σ Observation time period: 2 series NL ≥ 2

5. 61σ

6 QC measurement values (m) are outside x ± 1σ Observation time period: 3 series NT ≥ 6

6. 9m

QC measurement values (m) are on the same side as the mean value Observation time period: 5 series NT ≥ 9

2SD range

Defined target values (ranges)

Table Table B-1

The Multirule process is applied after each individual measurement. Multirules are only applied to the corresponding control material (e.g. COMBITROL TS+).


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6 Quality control

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QC consequences

QC consequences By default, the QC consequence "QC error" should be assigned to all parameters. Press the following buttons to set or check the t he assigned QC consequences: h [Setup] > [Parameter] > [Miscellaneous settings] >

[QC Consequences]

Figure Figure B-23

Description of the QC consequences: Ignore:

if one of the set rules is broken, no consequences will be set. QC warning: through a warning, the respective parameter will be marked in the "Ready" screen, but remains ready for measurement. QC error: the parameter will be blocked if one of the adjusted rules is broken. The parameter will be identified accordingly in the Ready screen.



cobas b 121 system

6 Quality control QC unlock

QC unlock QC warning Performing a QC measurement using the same material/level combination removes a QC warning.

QC error A locked parameter may be unlocked only if the c ause of the lockout is known and the error is corrected (e.g., timeout or measurement of wrong ampoule).

Automatic lockout reversal After the error has corrected, performing a QC measurement using the same material/level combination automatically unlocks the locked parameter. Manual lockout reversal A locked parameter may be un locked manually only if the same material/level combination is no longer available. WARNING

In this case, repeat the QC measurement with a new material/level combination of a different batch. When performing QC measurements, follow the guidelines described in section General QC concept and and analyze it as described under Important information on page page B-19 B-19. concerning the analysis of QC measurement results on To ignore the result violates the accepted QC rules!

Press the following buttons to unlock the QC lock: h [Setup] > [Parameter] > [Miscellaneous settings] > [QC unlock]

An overview displays all parameters locked as a result of non-compliant QC measurements. Pressing this button unlocks each of the locked parameters individually.

Pressing [All] unlocks all parameters.

Exchange the electrode e


See Chapter 9 Maintenance, section Replacement of the electrodes and the MCon on page page C-20 C-20!

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QC troubleshooting

QC troubleshooting Description of the current problem After a QC measurement, one or more parameters are assessed as "not OK" (QC warning or QC block). The relevant parameters are shown accordingly in the "Ready" screen. When the respective parameter button is pressed, a status report appears. e

See Chapter 10 Troubleshooting , section Electrode status !

The QC problem can only be solved by a correct QC measurement within the range r ange if the same material / level combination is measured.

Classification of QC problems Group A The cause is an aspirating or positioning problem with the QC sample. In this case, usually more than one parameter is affected. aff ected. A cause belonging to Group A can be identified in the data base under "QC data" when an error message appears for the corresponding parameter instead of a result. Group B The cause is a QC result that exceeds the target value range. A cause belonging to Group B can be identified in the data base under "QC data" when there is a QC result, but it exceeds the target value range.

Troubleshooting Troubleshooting – Group A (aspirating or positioning problem) 1

Check whether all parameters are calibrated.

2

Repeat the QC measurement (with same material / le vel combination)

3

In event of repeat error: o

If an AutoQC module is in use, a manual QC measurement with the same material / level combination must be carried out.

o

If the manual QC measurement shows the same problem, continue with Point 4.

o

If the manual QC measurement is "OK", clean the sample port, needle and washing plate and compare the ampoule status in the AutoQC mat detail screen with the actual availability of the ampoules in the AutoQC module. e

4


See Figure Figure B-17 on page B-24! B-24!

o

Repeat the QC measurement (with same material / le vel combination).

o

If the error persists, contact customer service.

For the measuring chamber, call up an "Internal cleaning of sample path" ([System] > [Wash & clean] > [Automatic routines]). Then, carry out a blood blo od sample measurement in order to wet the liquid paths. June 2008 Instructions for Use · Version 10.0

cobas b 121 system

6 Quality control QC troubleshooting

5

Repeat the QC measurement (with same material / le vel combination) o

If the error persists, contact customer service.

Troubleshooting Troubleshooting – Group B (QC result exceeds the target value range) range) 1

A system calibration must be carried out for the affected parameters.

2

The following points must be checked:

3

o

It must be checked whether the target value ranges under [Setup] > [QC material] > [QC material] > (select appropriate material) > [Ranges] correspond to the target value ranges stated in i n the package insert.

o

If an AutoQC module is in use, it must be checked whether the lot number printed on the AutoQC mat corresponds to that under [Setup] > [QC material] > [QC material].

o

It must be checked whether before use the QC ampoules have been stored for at least 24 hours at room temperature or in the AutoQC module.

o

In event of manual QC measurement, it must be ensured that the t ime between opening the ampoules and the QC measurement is kept as short as possible. Furthermore, it must be ensured that the ampoule adapter is used.

o

If an AutoQC module is in use, it must be ensured that the AutoQC temperature deviates by less than 5 °C from the ambient temperature. Check under [System] > [Component test] > [Control sensors] > [Temperature [Temperature control] > [AutoQC temperature].


4


5


If the error persists, call up an "Internal cleaning of sample path" ([System] > [Wash [Wash & clean] > [Automatic routines]). Then, carry out a blood sample measurement in order to wet the liquid paths.

If the error persists, replace the affected electrode/sensor. If all parameters are affected at the same time, t ime, replace the reference electrode.

If the problem cannot be solved successfully, successfully, the Customer Service Serv ice must be notified.

June 2008 B-33

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QC troubleshooting



cobas b 121 system

7 Calibration Table of contents

Calibration

In this chapter, all automatic and user-activated calibrations are described.

In this chapter

Chapter

7

Calibration - general ............................................................ ............................ ................................................................ ..................................... ..... B-37 Calibration progress indicator ............................................................................ ................................................. ........................... B-37 Automatic calibrations .............................................................. .............................. .......................................................... .......................... B-38 System calibration .............................................................................. ................................................. ........................................ ........... B-38 2P calibration (2P cal) ....................................................................... .......................................... ......................................... ............ B-38 1P calibration (1P cal) ....................................................................... .......................................... ......................................... ............ B-38 Recalibration ............................................................ ............................ .............................................................. ...................................... ........ B-38 User activated calibrations ................................................................... ...................................... ............................................ ............... B-39 Calibration for "Ready" ......................................................................... ........................................... ...................................... ........ B-39 System calibration .............................................................................. ................................................. ........................................ ........... B-39 Conductivity calibration ........................................................... .............................. ................................................. .................... B-39 1P calibration ............................................................ ............................ ................................................................ ..................................... ..... B-39 2P calibration incl. O2 ........................................................... ............................. ...................................................... ........................ B-39 2P O2 calibration ............................................................. .............................. ............................................................. .............................. B-40 2P calibration without O2 .......................................................... ............................ ................................................. ................... B-40


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Table of contents



cobas b 121 system

7 Calibration Calibration - general

Calibration - general cobass b 121 system employs a patented method that allows the simultaneous The coba calibration of P CO CO2, pH, Na+, K+, Ca2+ and Cl– electrodes while using only two calibration solutions (C1 calibration solution 1 and C2 calibration solution 2).

The chemical properties of the solutions and the concentration of their components make the system insensitive to environmental influences during storage and use.

Calibration progress indicator

Figure Figure B-24

The progress bar visible in the calibration calibr ation progress indicator is divided into the following sections:


o

The gray area indicates the maximum time how long the respective calibration may last.

o

The yellow area in the bar indicates the estimated duration of the calibration. An average value is used as the basis. This area does not change during the calibration.

o

The green bar is the actual progress indicator.

o

The green marking above the bar indicates the minimum possible duration of the respective calibration.

June 2008 B-37

7 Calibration

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Calibration - general

Automatic calibrations The following calibrations are automatically initiated and performed by the analyzer. System calibration Every 8, 12 or 24 hours (default) which includes the following: o

Cleaning with internal cleaning solution

o

Automatic conditioning of the Na electrode (every 24 hours)

o

Calibration of the mixing system

o

2 point calibration of all parameters

The user can set a permanent start time for the system calibration. This enables completion of calibration tasks while the instrument is not in use or when the workload in the laboratory or station is smaller. e


2P calibration (2P cal) This calibration is a 2 point calibration of all parameters. Adjustable: 4, 6, 8, and 12 hours (standard). 1P calibration (1P cal) This calibration is a 1 point calibration (incl. O2) of all parameters. Adjustable: every 30 minutes, 1 hour (standard). Recalibration This calibration is a 1 point calibration (without O2) performed after every measurement taken.



cobas b 121 system

7 Calibration Calibration - general

User activated calibrations o

Calibration for "Ready"

o

System calibration

o

Conductivity calibration

o

1P calibration

o

2P calibration incl. O2

o

2P O2 calibration

o

2P calibration without O2

Press: h [More functions] > [System]

Figure Figure B-25

Using the [line up] / [line down] buttons you may now select the desired cali bration. Start the selected calibration by pressing this button.

Calibration for "Ready" The instrument automatically selects the calibration that is required to transfer all parameters to the "Ready" status. System calibration e

See System calibration on page B-38! B-38!

Conductivity calibration Calibrate the conductivity system with the C1 and C2 calibration solutions in order to determine the actual mixing ratio in combination with the mixing system. 1P calibration This calibration is a 1 point calibration (incl. O2) of all parameters. 2P calibration incl. O2 This calibration is a 2 point calibration of all parameters. Roche Diagnostics Instructions for Use · Version 10.0

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7 Calibration

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Calibration - general

2P O2 calibration This calibration is a 2 point calibration for the P O2 electrode. 2P calibration without O2 This calibration is a 2 point calibration of all parameters except P O2.



cobas b 121 system

8 Operating modes Table of contents

Operating modes

In this chapter, all the individual, independent software modes (analyzer, (analyzer, setup, data manager and info) are described.

In this chapter

Chapter

8

Operating modes - general ................................. .. ............................................................ ...................................................... ......................... B-43 User interface ............................................................ ............................ ............................................................. ................................................. .................... B-43 Parameter ............................................................... ............................... .............................................................. .............................................. ................ B-44 Parameter – Display on the "Ready" "Ready" screen ................................................. ............................. .................... B-44 Additional ........................................................ ......................... ............................................................ .............................................. ................. B-44 Input parameters parameters - patient information ....................................................... ........................... ............................ B-44 Input parameters - measurement measurement information ............................................ B-45 Notation of the measurement, measurement, input, and calculation parameters ............. B-45 Buttons .............................................................. ............................. ................................................................ ............................................. .............. B-47 Analyzer mode .................................................................. ................................ ................................................................. ......................................... .......... B-49 "Ready" screen ................................................................................... ..................................................... ................................................ .................. B-49 System ................................................................. ................................ ................................................................ ................................................. .................. B-51 Quick access ............................................................ ............................. ........................................................... ............................................. ................. B-51 QC measurement ............................................................ ............................ ................................................................ .................................... .... B-52 Setup ........................................................... ............................... ........................................................... ......................................................... .......................... B-52 Database .............................................................. .............................. .............................................................. ................................................. ................... B-53 Description of the buttons and their function ............................................. B-54 More functions of the database ...................................................... .......................... .......................................... .............. B-54 Data export – PCMCIA card (for example) example) ................................................. ............................. .................... B-55 Patient data ................................................................ ............................... .................................................................. .................................... ... B-56 Measuring data .......................................................................................... ......................................................... ..................................... .... B-57 Calibration data ........................................................ ......................... ............................................................ ..................................... ........ B-57 QC data ................................................................ ................................ .............................................................. .......................................... ............ B-58 Instrument data .......................................................... ........................... ............................................................. ................................... ..... B-58 Info ................................................................. ................................ ................................................................ ...................................................... ....................... B-59 Roche info .............................................................. .............................. .............................................................. ........................................ .......... B-59 Version numbers ............................................................ ............................. ............................................................. .................................. B-59 Fill levels ........................................................... ........................... .............................................................. .............................................. ................ B-59 Roche Diagnostics Instructions for Use · Version 10.0

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Table of contents

Help .............................................................. .............................. .............................................................. .................................................. .................... B-59 Sensor status ............................................................ ............................ .............................................................. ...................................... ........ B-60 Counter overview .............................................................. .............................. ............................................................ ............................ B-60 Software overview ..................................................................................... ....................................................... .............................................. ................ B-61 Software overview - Setup ................................................................................. ................................................... .................................. B-62



cobas b 121 system

8 Operating modes Operating modes - general

Operating modes - general cobass b 121 system is a combined The coba combined bloodgas, electrolyte, and tHb/SO2 analyzer. It is possible to complete database procedures or to make simultaneous adjustments during measurement or calibration.

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

Analyzer

Measuring, QC, system, calibration, commonly used functions

o

Setup

Instrument settings

o

Database

Data about patients, measurements, calibration, QC, and the instrument

o

Info

Roche info, version numbers, fill levels, help, sensor status

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

Top level of the analyzer mode - "Ready" J

A

I

B

C D

E

F

G

H

A

Operating mode - selection button

F

Act. status

B

Parameter status and selection

G

Type and time of next calibration

C

Status line

H

Current time

D

AutoQC act. / deact.

I

More functions

E

Network act. / deact.

J

Info

Figure Figure B-26 e


For more detailed information refer to the respective chapters in these Instructions for Use as well as the Reference Manual .

June 2008 B-43

8 Operating modes

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User interface

Parameter Parameter – Display on the "Ready" screen Depending on the settings and the status of the instrument, the parameter buttons may have the following appearance: Parameter activated and ready Parameter temporarily deactivated (but calibrated) Parameter activated with QC warning Parameter temporarily deactivated with QC warning Parameter not ready (not calibrated)(a) Parameter not ready (due to QC lock) Parameter not ready due to remote lock lo ck Parameter permanently deactivated (under "Setup") (a) Pressing the parameter parameter button button produces produces a status status report e

See Chapter 10 Troubleshooting , section Electrode status on page D-14! D-14!

Additional o

Operator ID

o

Sample type

o

Blood type

o

Specimen ID

o

Puncture site

o

ALLEN test

o

A/F (adult/fetal)

o

Pat ID

o

Last name

o

First name

o

Middle initials

o

Date of birth

o

Gender

o

Pract. Pat ID

o

Height

o

Weight

Input parameters - patient information


o

Insurance code

o

Suffix

o

Title

o

Maiden name

o

Ethnic origin

o

Address

o

Phone no.

o

Diagnosis

o

Medication

o

Diet

o

Admission date

o

Admission time

o

Discharge date

o

Discharge time

o

Admission status

o

Location

o

Diagnose code

o

Relig. denom.


cobas b 121 system

8 Operating modes User interface

o

Marital status

o

Isolation status

o

Patient language

o

Hospital service (KH service)

o

Hospital institute

o

Dosage cat.

o

Remark

o

o

Input parameters - measurement information o

Physician

o

Remark

o

Acceptor

o

Date drawn

o

Time drawn

o

Place drawn

o

Danger code

o

Clinic info

o

Container

o

24 hr. urine

o

Ventilation mode

o

VT

o

MV

o

PIP

o

Ti

o

Te

o

SRATE

o

ARATE

o

PEEP

o

MAP

o

Flow rate

Notation of the measurement, input, and calculation parameters(a) Measured parameters

P O2

Oxygen partial pressure

P CO CO2

Carbon dioxide partial pressure

pH

Negative lo logarithm of of th the hy hydrogen io ion ac activity

+

Calculated parameters

Na

Sodium concentration

K+

Potassium concentration

Cl–

Chloride concentration

Ca2+

Calcium concentration

Hct

Hematocrit

t Hb

Total he hemoglobin concentration

SO2

Functional oxygen saturation

Baro

Air pressure

H+

Hydrogen Hydrogen ion concentration

cHCO3–

Bicarbonate concentration in plasma

ctCO2(P)

Total CO2 concentration in plasma

ctCO2(B) (B)

Tota otall carb carbon on diox dioxid idee con conce cent ntrat ratio ion n in in blo blood od

BE

Base excess of blood

BEact

Base excess of blood at current oxygen saturation

BEecf

Base excess of the extracellular fluid

BB

Buffer bases

ctO2

Total oxygen concentration

pHst

Standard pH value

cHCO3–st

Standard bicarbonate concentration in plasma

AO2 P AO

Alveolar oxygen partial pressure

RI

Respiratory index

nCa2+

Standardized ionized calcium (pH = 7.4)

(a) Details Details and calcu calculatio lation, n, see Reference Manual Roche Diagnostics Instructions for Use · Version 10.0

June 2008 B-45

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User interface

Additional calculated parameters

SO2(c) (c)

Func unction tional al oxyg xygen satu satura rati tion on calcu alcula late ted d wit with h P 50 50 as default value

AaDO2

Alveolar-arterial Alveolar-arterial oxygen partial pressure

a/AO2

Alveolar-arterial Alveolar-arterial oxygen partial pressure ratio

AG

Anion gap

MCHC MCHC

Middl iddlee corp corpus uscu cula larr hem hemoglo oglobi bin n con conccentr entrat atio ion n

Osm

Osmolality

Hct(c)

Hct calculated from tHb

P/F Index

P aO aO2/F IO IO2 ratio

Qs/Q Qs/Qtt

Shun Shuntt - quo quoti tien entt betw betwee een n bot both h oxy oxyge gen n con conccentr entrat atio ion n dif diffe ferrenc ences

Qt

Differ ference of ox oxygen concentra tration between alveolar and and mixed venous blood

avDO2

Arterial-venous oxygen level difference dif ference

OER

Oxygen extraction ratio

Calculation after the second measurement if the following conditions are fulfilled:

Calculated parameters at the patient's temperature

Input parameters


o

Two sequential measurements with wit h the same Patient ID

o

One measurement of arterial and one of mixed venous blood

o

Maximum time interval = 30 minutes

AO2t P AO

Alveolar oxygen partial pressure at patient's temperature

RIt

Respiratory index at patient's temperature

AaDO2t

Alveolar-arterial oxygen partial pressure at patient's temperature

a/AO2t

Alveolar-arterial oxygen oxygen partial pressure ratio at patient's temperature

pHt

pH at patient's temperature

CO2t P CO

CO2 at patient's temperature P CO

P O2t

P O2 at patient's temperature

H+t

Hydrogen concentration at patient's temperature

50 P 50

Oxygen partial pressure at 50% oxygen saturation (default value depending on A/F setting, no manual input possible)

R

Respiratory quotient (=gas exchange ratio)

IO2 F IO

Proportion of inspiratory oxygen

tHb

Total hemoglobin

Tempe empera ratur tur

Pati Patien entt temp temper eratu ature re


cobas b 121 system

8 Operating modes User interface

Buttons Buttton

Description

return to the highest level of the operating mode "Analyzer"

operating mode "Analyzer"

operating mode "Database"

operating mode "Setup"

button "Info"

More functions

confirm

cancel

activate / deactivate

start

move one line up / down page to the left / right, additional selection possible select the marked entry

move one level up / back

got ot additional views print add remove password


June 2008 B-47

8 Operating modes

cobas b 121 system

User interface

Buttton

Description

data input details



cobas b 121 system

8 Operating modes Analyzer mode

Analyzer mode The "Analyzer" operating mode contains parameter information (for example, "Ready"), system settings, and the QC measurement. The highest level of this operating mode is the "Ready" screen.

"Ready" screen The Ready screen is the central starting point for all operations. The instrument is is usually in the "Ready" state.


If a "mandatory input" field has been modified (in the "Setup" operating mode), measurement can begin only after entering the data associated wit h this input field. Every possible input value can be defined as a "mandatory input". NOTE

IMPORTANT: only one input value can be defined.

In the following example, the Pat ID has been defined as a mandatory entry.

Figure Figure B-28

Press this button and enter the Pat ID. The measurement can then be started. If the measurement is equipped with password protection, the "Ready" screen is covered by the password window but the parameter section remains visible (parameter information). Roche Diagnostics Instructions for Use · Version 10.0

June 2008 B-49

8 Operating modes

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Analyzer mode

Figure Figure B-29

Press this button and enter the required password. The measurement can then be started. When a mandatory input or password is activated and the flap is opened without completing the input, one of the following messages appears: "Complete mandatory inputs" or "Close flap and enter password."

The system section can be reached directly and only from the "Ready" screen. This occurs by pressing the button [More functions]. This button calls up a window with which the following functions may be activated: act ivated: B

A

A

The window is automatically closed when

B

More functions

this button is pressed or after a time-out.

Figure Figure B-30



cobas b 121 system


System The following main menus are available:

Figure Figure B-31

Select the appropriate function.

Activate the marked entry.

Back to the top level of the analyzer mode (= "Ready" screen).

Quick access Using these functions, you can start the following fol lowing actions or change the following settings:

Figure Figure B-32


Start the selected function.


June 2008 B-51

8 Operating modes

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Analyzer mode

QC measurement This function helps start a quality control measurement. e

For more detailed information, see Chapter 6 Quality control !

Setup Use this function to make the following settings:

Figure Figure B-33



Back to the top level of the analyzer mode (= "Ready" screen)

You can activate the de sired setting directly by pressing the re spective line on the screen. e


For an exact description of this operating mode refer to the Reference Manual , Chapter Setup!


cobas b 121 system


Database Use this function to retrieve the following data:

Figure Figure B-34

Select the respective database.


You can activate the de sired database directly by pressing the respective line on the screen.

The following query criteria are possible: o

All All data of the selected database are listed.

o

From DD.MM.YYYY till DD.MM.YYYY The data of a random date range are listed. The older date must be entered in the first input field.

o

From DD.MM.YYYY till today The data of a random date to today are listed.

o

From 15.10.2001 till DD.MM.YYYY The data with the oldest date up to a random date are listed.


June 2008 B-53

8 Operating modes

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Analyzer mode

Description of the buttons and their function The buttons described here are used only in the "Dat abase" operating mode. mark ark

The co comple pleted ted li line is mark arked, ed, th the cur curso sorr mo moves to to the the next lin line.

sear search ch

This This func functi tion on ena enabl bles es the the sear search ch acc accor ordi ding ng to to sear search ch cri crite teria ria in in asce ascend ndin ingg or desc descen endi ding ng ord order er..

sort

This function enables sorting of records. Sort criteria:

Date Date / Time Time (Only (Only for for meas measur urem emen ent, t, calib calibra ratio tion, n, QC, QC, and and inst instru rume ment nt data data))

Up arr arro ow:

the the rec recor ords ds are are aarr rran ange ged d in in asc ascen endi ding ng orde orderr (ol (olde dest st date date is at the the top top))

Down Down arrow: arrow:

the recor records ds are arrange arranged d in in desc descen endin dingg orde orderr (yo (youn unges gestt date date is at the top). top).

Sort criteria:

OpID (Only for measurement data)

Up arro rrow:

the records ar are arr arraanged in ascendin ding or order.

Down Down arro arrow: w:

the the rec recor ords ds are are aarr rran ange ged d in in des desccendi ending ng orde orderr

Sort criteria:

PatientenID (Only for measurement data)

Up arro rrow:

the records are arra rranged in ascendin ding order

Down Down arro arrow: w:

the the rec recor ords ds are are aarr rran ange ged d in in des desccendi ending ng orde orderr

Sort criteria:

Last name(Only for measurement data) The records are arranged alphabetically according to the patients' names.

Up arr arrow ow::

the the rec recor ords ds are are arra arrang nged ed alph alphab abet etic ical ally ly in asce ascend ndin ingg ord order er (for (for exam exampl ple, e, from from top top to to bottom - Z->A)

Down arrow:

the records are arranged alphabetically in descending order (for example, from top to bottom - A->Z)

QC statistics

Only for QC data:

The marked ranged is depicted as a Levey Jennings chart. Only for patient data:

The measurement data associated with the selected entry is shown. More functions of the database

Figure Figure B-35


Mark Mark the date date rang rangee

Using Using this this functi function on allo allows ws for for mark markin ingg a random random date range.

Expor t data

The marked data range is exported to a PCMCIA card or through an interface. June 2008 Instructions for Use · Version 10.0

cobas b 121 system


Delete data

Delete the marked data range. e

Screen shot of the database overview

A list of all available forms is displayed (userspecific and standard). This se lection remains the defined standard until a new form is s elected. e

Optim Optimiz izee data databa base se

See the Reference Manual , chapter Database section Delete data!

See the Reference Manual , chapter Setup section Displays & reports > Measuring data > Measurement > DB - Overview !

The The data databa base se is is opti optimi mize zed. d. Mor Moree disc disc-s -spa pace ce is is available.

Data export – PCMCIA card (for example) 1


A

Printer cover

A


Insert the PCMCIA card into the port.

Please be sure that the card is inserted correctly (see below).

A

A

B

Front side

B

Reverse side



June 2008 B-55

8 Operating modes

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Analyzer mode

3

Press [More functions] and then [Export data]. The following screen appears:


After completing all entries, press [Start]. The data is exported.

e

For an exact description of this operating function, see the Reference Manual , chapter Database!

Patient data

Figure Figure B-39

Press these buttons to scroll through all parameters. Select the marked entry - the patient's data is shown.



cobas b 121 system


Measuring data

Figure Figure B-40

Press these buttons to scroll through all parameters. Select the marked entry - the results screen associated with this measurement is then displayed.

Calibration data

Figure Figure B-41

Starting this function, the instrument displays an overview of the saved calibration data. Every line displays a short record of a calibrati on and contains the date, time, type ty pe of calibration, as well as the t he parameter's condition after the calibration. Press these buttons to scroll through all parameters. Select the marked entry - the results screen of this calibration is then displayed.


June 2008 B-57

8 Operating modes

cobas b 121 system

Analyzer mode

QC data

Figure Figure B-42

Starting this function, t he instrument displays an overview of the saved QC data. This screen shows you, based on selected query criteria, all QC materials that were measured up to this point, the level, lot lo t numbers, and the date on which the QC files were begun. After you have selected and completed an entry, press the [Zoom] button to receive all available information on the completed QC file. Every line shows the date, t ime, operator ID (when available), and the corresponding status of the available parameters. Press these buttons to scroll through all parameters. Select the marked entry - the results display of the selected QC data are displayed.

Instrument data

Figure Figure B-43

Starting this function, an overview of the saved instrument data is displayed. Press these buttons to scroll through all parameters. Select the marked entry - details about the entry are displayed.



cobas b 121 system


Info Use this function to retrieve the following information:

Figure Figure B-44

Roche info This displays the name, address, telephone number, and e-mail address that you defined under: h [Setup] > [Instrument] > [Roche info] e


Version numbers This lists the software version. Fill levels Use this function to check the fill level. e

See Chapter 9 Maintenance, section Check fill levels on page page C-7! C-7!

Help Use this function to retrieve online-help information.

Figure Figure B-45


June 2008 B-59

8 Operating modes

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Analyzer mode

Sensor status e

See Chapter 10 Troubleshooting , section Sensor status on page D-16! D-16!

Counter overview

Figure Figure B-46


Lifetime Lifetime sample sample counte counter: r:

Number Number of all measur measured ed samples samples since since initial initial startup startup

Sample counter:

Number of measurements

QC counter:

Number of QC measurements

Clea Clean ning ing count ounteer:

Numbe umberr of measu easurrements ents sinc ince the the las lastt au automa tomati ticc cleaning


cobas b 121 system

8 Operating modes Software overview

Software overview

A

B

A

Software overview - Database

B

Software overview - Info



June 2008 B-61

8 Operating modes

cobas b 121 system

Software overview

Software overview - Setup

Par t 1

Part 2

Figure Figure B-48



Maintenance

9

C

Maint ainten enan ance ce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3 C-3

June 2008

cobas b 121 system

9 Maintenance Table of contents

Maintenance

In this chapter, all maintenance maintenance work is described that is necessary for trouble-free operation of the instrument.

In this chapter

Chapter

9

Maintenance - general .................................................................................................C-5 Decontamination ........................................................................................................C-5 General information .............................................................................................C-5 Sample port module ..............................................................................................C-5 Touch screen ..........................................................................................................C-6 Surfaces of the instrument ....................................................................................C-6 Tubing paths ..........................................................................................................C-6 Recommended decontaminant .............................................................................C-6 Surfaces ............................................................................................................C-6 Tubing paths ....................................................................................................C-6 Daily .............................................................................................................................C-7 Check fill levels ......................................................................................................C-7 Check printer paper ........................................ ..... ................................................................... ...................................................... ...................... C-7 Weekly ..........................................................................................................................C-8 Clean needle and fill port ......................................................................................C-8 Semi annual .................................................................................................................C-9 Replacement of the peristaltic pump tubes ..........................................................C-9 Sample-dependent maintenance procedures ...........................................................C-10 Exchanging the solutions ....................................................................................C-10 C1 calibration solution 1 and C2 calibration solution 2 .............................C-10 C3 fluid pack ..................................................................................................C-10 Waste material .....................................................................................................C-12 Remove the waste container (W waste container) .......................................C-12 Empty the waste container ............................................................................C-13 Using the empty C1 calibration solution 1 bottle as W waste container ....C-14 Installing the waste container .................................. .. ............................................................. ..................................... ........C-14 C-14 Exchanging the fill port holder ...........................................................................C-15 Unscheduled ..............................................................................................................C-17 Roche Diagnostics Instructions for Use · Version 10.0

June 2008 C-3

9 Maintenance

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Table of contents

Cleaning the bottle compartment compartment ........................................................ ............................ .......................................... ..............C-17 C-17 Cleaning the drip tray and wash plate ................................................................C-17 Replacing printer paper ............................................................. ............................ .......................................................... ......................... C-19 Replacement of the electrodes and the MCon ...................................................C-20 Replacement of the reference electrode ..............................................................C-23 Cleaning the measurement chamber ..................................................................C-25 Removing obstructions .......................................................................................C-25 Decontaminate the tubing paths ........................................................................C-26 Cleaning the bypass .............................................................................................C-27 Cleaning the screen .............................................................................................C-28 Surfaces ................................................................................................................C-28 Adjusting the screen ............................................................................................C-28 Additional maintenance procedures ........................................................................C-30 Annual maintenance ...........................................................................................C-30 Maintenance overview ..............................................................................................C-31 Maintenance scheduler .............................................................................................C-32

Roche Diagnostics C-4


cobas b 121 system

9 Maintenance Maintenance - general

Maintenance - general After use, components of the instrument, including tubing, waste container, fill port, etc., contain biological fluids and represent a possible infectious risk. Handle these components with care and according to regulations surrounding potentially infectious material. Avoid contact with skin. Always wear gloves! Danger of infection!

Decontamination General information The purpose of this procedure is to minimize the risk of infections when replacing items that were in contact with blood. Perform these decontamination procedures regularly. regularly. Roche recommends following a decontamination procedure in addition to regulations specific to the laboratory. laborator y. Use only liquid disinfectant such as protein remover (Roche deproteinizer) or an alcohol-based (about 70%) surface disinfectant. Do not spray disinfectant directly onto the instrument bec ause this could cause malfunctions in the electronics. Do not use any type of bleaching agent. Exception: Roche Deproteinizer Do not attempt to decontaminate any par t of the instrument before shutting it down and unplugging it from the power source. ATTENTION

Before plugging the instrument back in and turning it on, always wait 15 minutes to allow the disinfectant to evaporate – Danger of fire and explosion! For safety reasons, only authorized technical service personnel may decontaminate the power pack!

Regularly decontaminate the following parts of the inst rument: o

Sample port module (incl. drip tray)

o

Touch screen

o

Surfaces of the instrument

o

Tubing paths

Sample port module e


See sections Clean needle and fill port on on page page C-8 and C-8 and Cleaning the drip tray and wash plate on page page C-17 C-17!

June 2008 C-5

9 Maintenance

cobas b 121 system

Decontamination

Touch Touch screen See section Cleaning the screen on page C-28! C-28!

e

Surfaces of the instrument e

See section Surfaces on page C-28! C-28!

e

See section Decontaminate the tubing paths on page C-26! C-26!

Tubing Tubing paths

Recommended decontaminant Do not use any type of bleaching agent. Exception: Roche Deproteinizer!

Surfaces Avoid contact with skin. Always wear gloves! Danger of infection!

70% alcohol decontaminant for bottles Tubing Tubing paths Avoid contact with skin. Always wear gloves! Danger of infection!

Protein remover (Roche Deproteinizer) Deproteinizer)

o

Potential dangers Due to the alkaline and oxidizing character of this preparation, we cannot rule out local irritation to the skin, eyes, and mucous membranes.

o

First Aid measures After inhalation: breath fresh air, drink large amounts of water After skin contact: wash with w ith generous amounts of water, remove contaminated clothing After eye contract: rinse eyes with generous amounts of water, contact contact an eye doctor After drinking: drink large amounts of water, water, avoid vomiting, contact a doctor.



cobas b 121 system

9 Maintenance Daily

Daily Check fill levels Check daily the fill levels of the solutions (C1 calibration solution 1, C2 calibration solution 2) and the waste container (W waste container). Perform visual checks or select: h [Info] > [Fill levels]

Figur Figure e C-1

Exchange empty bottles, bottles whose usage date has expired, and full waste water bottles. e

See section Exchanging the solutions on page C-10! C-10!

Check printer paper Check daily to be sure that sufficient suff icient printer paper is available and exchange it if necessary (paper is sufficient for about ab out 200 measurements with 15 cm / measurement). e

See section Check printer paper on on page page C-7! C-7!

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


June 2008 C-7

9 Maintenance

cobas b 121 system

Weekly

Weekly Clean needle and fill port Handle these parts with care – danger of injury! Always wear gloves! Danger of infection! 1

While in the "Analyzer" operating mode, press:

h [More functions] > [System] > [Wash [Wash and clean] > [Decont. sample port module]

t

Figur Figure e C-2 2


3

Use a moist (Deproteinizer for example) paper towel or gauze to clean the fill port and remove any deposits on the needle (see Figure Figure C-3/1+2). C-3/1+2).

4

Close the flap to the syringe position (half-opened position).

5

Clean the tip of the needle (see Figure Figure C-3/3). C-3/3).

(1)

(2)

(3)



Close the flap.


cobas b 121 system

9 Maintenance Semi annual

Semi annual Replacement of the peristaltic pump tubes While in the "Analyzer" operating mode, press: h [More

functions] > [System] > [Tools] > [Tubing exchange] > [Replace PP

tubing] Follow the instructions on the screen and proceed as follows: 1

Open the top cover.

2

Open the peristaltic pump's clear plastic plast ic cover (tension lever).

3

Push the linear clamp (white plastic part) upwards (seeFig (seeFigure ure C-4/1). C-4/1).

4

Remove the complete tubing set (tubing holder and tubing) (see Figure Figure C-4/2). C-4/2).

A

B C

(1)

A

Tension leve r

B

Pump head

C

Linear clamp

(2)


Check if the five rollers on the peristaltic peristalt ic pump rotate easily. If defective, please contact Roche Technical Support.

6

Place the new tube around the rolling wheel.

7

Close the acrylic glass cover (tension lever). This presses the tubing holder into the sealer.

8

Close the top cover. cover.

The tubes may drip after disconnection. Remove excess fluids with a clean, absorbent cloth.


June 2008 C-9

9 Maintenance

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Sample-dependent maintenance procedures

Sample-dependent maintenance procedures Exchanging the solutions Use of calibration solutions that were not produced by Roche may lead to an invalidation of the instrument's guarantee. All reagents are suitable only for diagnostic in-vitro use!

Use of calibration solutions that were not produced by Roche may lead to an invalidation of the instrument's guarantee. All reagents are suitable only for diagnostic in-vitro use! After replacing a solution, a quality control measurement must be performed with all 3 levels (low, normal, high). Make sure that the results agree with the target values. e


C1 calibration solution 1 and C2 calibration solution 2 Depending on the rate of measurement and/or the on-board stabilit y, these solutions should be exchanged every 2-4 weeks. The screen displays the appropriate information. The bottles of C1 and C2 solution must always be exchanged simultaneously. Fluids remaining in the bottles may never be mixed together because this may result in calibration errors! Reuse of this bottle can lead to errors during calibration! Insert another bottle that has not yet expired.

C3 fluid pack Depending on the rate of measurement and/or the on-board stabilit y, this fluid pack should be exchanged every 4-6 weeks. The screen displays the appropriate information. Reuse of this bottle can lead to errors during calibration! Insert another bottle that has not yet expired.

It contains the following solutions:


o

Solution for calibrating the P O2 zero point

o

Solution for conditioning the Na+ electrode

o

Cleaning solution

o

Reference Reference solution sol ution


cobas b 121 system

9 Maintenance Sample-dependent maintenance procedures

Implementation:

1

Open the bottle compartment cover. cover. The following fol lowing screen appears:


Open the docking mechanism and remove the bottles that are to be exchanged (see Figure Figure C-6). C-6).

Figur Figure e C-6

Dispose of the bottles according to local regulations (hazardous waste!)

NOTE

3

Next, scan in the barcode of new bottle.

4

If a barcode scanner is not available, enter the correct barcode with the numerical keyboard and confirm your entry. entr y.

Remove rubber sealings from C3 Fluid Pack before inserting it! 5

The instrument recognizes the correct solution and checks the expiration date. The respective bottle blinks on the screen. If the bottle has passed the expiration date, the screen displays a warning.

Reuse of this bottle can lead to errors during calibration! Insert another bottle that has not yet expired. 6

Push the bottle onto the proper position positi on until it engages.

7

Close the docking mechanism. After inserting a full bottle, confirm with this button.


June 2008 C-11

9 Maintenance

cobas b 121 system


If inserting a bottle that has already been partially used, press this button and enter the fill level. Use the markings on the label to estimate the fill level of a bottle that is partially full. 8

A numerical keyboard appears on the display. Enter the correct fill level in % and confirm with the [OK] button.

9

Close the bottle compartment compart ment cover. cover. The solutions are automatically aspirated upwards (detection in the flap).

Waste material Remove the waste container (W waste container) 1

Open the bottle compartment cover. cover. The bottle bott le exchange image appears on the display (see Figure Figure C-7). C-7).

Figur Figure e C-7

Always wear gloves! Danger of infection! 2

Open the docking mechanism and remove the waste container. container.

Dispose of the waste container according to local regulations (hazardous waste!).



cobas b 121 system


Empty the waste container Always wear gloves! Danger of infection! 1

Place the bottle tool on the screw cap (Fig (Figure ure C-8). C-8).


Open the screw cap by pressing the grips together and rotating t hem counter clockwise (Fig (Figure ure C-9). C-9).


When removing the screw cap, make sure that the green e lement inside the bottle is not moved or removed (Fig (Figure ure C-10 C-10).

Figure Figure C-10

Empty the waste material and decontaminate the container according to loc al regulations (hazardous waste material!). Flush the waste container cap with plenty of water. 4


Screw the cap back onto the bottle. The cap must be screwed shut until completely closed! June 2008 C-13

9 Maintenance

cobas b 121 system


Using the empty C1 calibration solution 1 bottle as W waste container Flush the C1 bottle cap with plenty of water.

Remove the sticker from the empty bottle of C1 solution (see Figure Figure C-11 C-11). This sticker may not be reused – discard immediately. immediately.

A

A

Remove the C1 sticker from the bottle at this

Pull off the sticker beginning from the

position.

lower right corner (arrow) until the

"W" sticker on the bottle of C1.

sticker "Waste" is completely visible.

Figure Figure C-11

Installing the waste container 1

Push the bottle to the position for "W" until it engages.

2

Close the docking mechanism and confirm.

3

The fill level monitoring feature recognizes the waste container as "empty".

4

When inserting a bottle that is not completely empty, empty, press this button. A numerical keyboard appears on the display. Enter the approximate fill level in % and confirm with the [OK] button.

5


CAUTION! If the W waste container is mistakenly reused as C1 calibration solution 1, a section of the tubing must be exchanged! Please contact technical support immediately!



cobas b 121 system


Exchanging the fill port holder The fill port holder is part of the sample port module and should be exchanged every 3000 measurements.

Handle these parts with care. Danger of injury! CAUTION

Always wear gloves! Danger of infection!


[Wash [Wash and clean] > [Decont. sample port

module] 1


2

Rotate the fill port holder in the direction of the arrow (see the marking on the fil l port holder). It will come out of the axis and snap out of place (see Figur Figuree C-12 C-12/1).

CAUTION: Do not bend the needle! 3

Carefully remove the fill port holder from the needle (see Figure Figure C-12 C-12/2).

A

( 1)

A

(2)

Axis

Figure Figure C-12


June 2008 C-15

9 Maintenance

cobas b 121 system


4

Place the new fill port holder (with integrated fill port) over the needle. It is easier if you turn the holder around so that t hat the bottom side is showing on top (see Figur Figuree C-13 C-13).

Figure Figure C-13 5

Snap the fill port holder evenly onto the axis.

Do not bend the needle!


Close the flap.

Dispose of the used fill port holder in accordance with local regulations (hazardous waste!).



cobas b 121 system

9 Maintenance Unscheduled

Unscheduled Cleaning the bottle compartment 1

Open the bottle compartment cover. cover. The bottle bott le exchange image appears on the display. e

See Figure Figure C-7 on page C-12! C-12!

2

Open the docking mechanisms and remove all bottles.

3

Clean the bottle compartment with a towel soaked in disinfectant (deproteinizer for example).

4

Re-insert the bottles e

See section Using the empty C1 calibration solution 1 bottle as W waste container on page page C-14 C-14 and Installing the waste container on on page C-14! C-14!

Do not scan a barcode!

While in the "Analyzer" operating mode, press: h [More functions] > [System] > [Tools] [Tools] > [Fluid actions] > [Auto preparation routines]

Select successively "Prepare Calibration Solution C1" and "Prepare Calibration Solution C2". Start the process.

Cleaning the drip tray and wash plate The drip tray and the wash plate are parts of the sample port module. Handle these parts with care. Danger of injury!

Always wear gloves! Danger of infection!


[Wash [Wash and clean] > [Decont. sample port

module]


June 2008 C-17

9 Maintenance

cobas b 121 system

Unscheduled

A

Drip tray

B

Wash plate



2

Remove the sample drop cup and clean it according to local regulations (see Figur Figuree C-16 C-16/1).

3

Open the bottle bot tle compartment cover. cover.

4

Remove the red tube connector from the wash plate (see Figure Figure C-16 C-16/2)

5

Push the wash plate down (to unlock) and pull it out (see Figur Figuree C-16 C-16/3). The wash plate is locked when the plug is sticking out and cannot be removed.

( 1)

( 2)

( 3)

Figure Figure C-16


6

It is best to clean the wash plate under running water, then, dry well.

7

Push the wash plate back in completely and attach the tub e plug.

8

Push the drip tray in.

9

Close the flap.

10



cobas b 121 system


Replacing printer paper The printer paper is heat sensitive on one side only. Please make sure that you insert the paper roll correctly. correctly. 1


2

Remove the empty cardboard roll.

3

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

4

Place the new paper roll into the holder.

5

Make sure that the printer lever is in the "down" position (see Figure Figure C-17 C-17).

6

Feed in the beginning of the paper according to the sticker on the inside of the printer cover (see Figure Figure C-18 C-18).

A

A

printer lever

Figure Figure C-17 C-17 7

The paper is automatically pulled into the printer.

8

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

A

A

slit in the printer cover

B

Figure Figure C-18


June 2008 C-19

9 Maintenance

cobas b 121 system

Unscheduled

Replacement of the electrodes and the MCon 1

Open the top cover and measurement chamber cover. The following image appears on the screen:

Figure Figure C-19

A A

B

B

locking lever

B

MCon



3

Take the appropriate electrode/MCon and move it to the left.

4

Remove the particular electrode/MCon.

Dispose the electrode(s)/MCon according to local regulations (hazardous waste!) 5

If necessary, clean the measuring chamber with a towel soaked in disinfectant (Deproteinizer for example).

If a new electrode is not available, inser t a dummy electrode instead. MCon and the reference electrode may not be replaced with a dummy electrode.



cobas b 121 system


WARNING

If an electrode is replaced by a dummy electrode, it must be immediately and permanently deactivated for calibration under [Setup] > [Parameters] > [Misc. settings] > [Act./deact. f. calibration]. The parameter(s) are not calibrated and ca nnot be measured. 6

Prevent the formation of gas bubbles in the t he inner electrolyte of the electrodes (see Figure Figure C-21 C-21/1). If necessary, remove remove air bubbles by holding the electrode vertically and by tapping lightly with your fingernail against the electrode body (see Figure Figure C-21 C-21/2). (1)

(2)

A

A

free of air bubbles


Insert the new electrode/MCon according to the t he colour code.

8

Push all electrodes slightly to the right so that they are lined up together without gaps.

9


10

Inspect the electrical contact of the electrodes by checking if they fit tightly. t ightly.

11

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



The corresponding electrode begins blinking on the screen.

June 2008 C-21

9 Maintenance

cobas b 121 system

Unscheduled

13


14

Carefully close the measuring chamber and then the top cover. cover.

15

A system calibration automatically starts.

16

After completing the calibration, perform a quality control measurement on all three levels (low, normal, high). While doing so, note the conformance of the results with the target values e


If a drift alarm of the P O2 electrode is remedied by manual cleaning, bacterial contamination is most likely present. In this case, optimize the cleaning interval to 3 days (see Reference Manual , Chapter ). If the drift alarm persists after 7 days, correct it by replacing the P O2 Operating modes ). electrode. After replacing the P O2 electrode, the 1-point calibration is performed at shorterintervals during the first hour. NOTE


After inserting a new pH electrode, the pH parameter may change to the non-calibrated status during the first hours. The pH electrode is not defective. To remedy remedy the situation, start a "Calibration for "Ready".


cobas b 121 system


Replacement of the reference reference electrode 1

Open the top cover and measurement chamber cover. The following image appears on the display:



3

Remove the reference electrode.

A A

locking lever

B

reference electrode

B

Figure Figure C-24


June 2008 C-23

9 Maintenance

cobas b 121 system

Unscheduled

4

Pull off the white plug (see Figure Figure C-25 C-25).

A A

A

white plug


Insert the new reference electrode.

6

Place the tube back into the tube guide slot.

Figure Figure C-26

If the tube does not lie precisely inside the guides, it may become pinched and thereby prevent aspiration of the reference solution, resulting in c alibration and measurement errors. 7

Affix the white plug at t he end of the reference electrode tube (see Figure Figure C-25 C-25).

Push the plug in completely. completely.


8


9

Inspect the electrical contact of the electrodes by checking if they fit tightly. t ightly.

10

Scan the barcode on the packaging of the inserted inser ted electrodes or enter it manually with the help of the [Data input] button.

11

The corresponding electrode begins blinking on the screen.

12


13

Close the measurement chamber and the top cover. cover. June 2008 Instructions for Use · Version 10.0

cobas b 121 system


14

A calibration is performed after a warm-up period.

15

After finishing the calibration, a quality control measurement must be performed with all 3 levels le vels (low, (low, normal, high). Make sure that the results agree wit h the target values. e


Cleaning the measurement chamber 1

Open the top cover and measurement chamber covers.

2

Remove all electrodes. e

See section Replacement of the electrodes and the MCon on page C-20! C-20!

3

Clean the measuring chamber with a towel soaked in disinfectant (Deproteinizer for example).

4

Re-insert the electrodes.

Do not scan a barcode! 5

Close the measurement chamber and the top cover. cover.

6

A calibration is performed after a warm-up period.

7



Removing obstructions For removing obstructions in the sample path, proceed as follows: First determine whether the electrodes have any obstructions and replace them, if necessary.

If no obstructions are found in the electrodes, proceed as follows: 1

Open the instrument cover and the MC cover. cover. The following picture is displayed on the screen:

Figure Figure C-27 Roche Diagnostics Instructions for Use · Version 10.0

June 2008 C-25

9 Maintenance

cobas b 121 system

Unscheduled

2

Release the locking lever.

3

Open the flap to the marked capillary position (fully opened position).

4

The instrument is now in system stop.

Do not open the flap too quickly as there is a risk of small droplets on the point of the needle being squirted. The flap can also be opened to the marked syringe position (half-open position). While the flap is in this position, the needle and the syringe must be joined carefully by a tube. 5

Attach the syringe to the fill port.

6

Now draw the syringe carefully until fluid or air comes.

7

If necessary, repeat (several times).

8

Remove the syringe.

9

Close the flap again.

10


11

Carefully close the MC cover and then the instrument cover.

12

After the warming-up phase, call up "Internal cleaning of the sample path":

h [More functions] > [System] >

[Wash [Wash & clean] > [Automatic routines]

13

Then call up a system calibration.

14



Decontaminate the tubing paths Press: h [More functions] >

[System] > [Wash [Wash & clean] > [Decontaminate all tubes]

Follow the instructions on the screen.


1

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

2

Fill the shutdown kit about halfway with Deproteinizer. Deproteinizer.

3

Insert the shutdown kit into space C3.

4

Connect the tubes of the set with the connectors from C1 and C2 (Fig (Figur uree C-28 C-28).


cobas b 121 system



Press the [Start] button to begin beg in decontaminating the tubes.

6


Remove the remaining fluid from the tubes by briefly holding the tube s vertically, allowing the fluid to run back into the container. 7

Empty the container according to local regulations and fill the shutdown kit halfway with distilled water. water.

8

Replace the shutdown kit to the position of C3.

9

Connect the tubes of the set with the connectors from C1 and C2 (Fig (Figure ure C-28 C-28).

10

Press this button to begin cleaning the tubes.

11


Remove the remaining fluid from the tubes by briefly holding the tube s vertically, allowing the fluid to run back into the container. 12

Press the [Start] button to begin emptying the tubes.

13

Re-insert the bottles C1, C2, and C3. e

14

See section Exchanging the solutions on page C-10! C-10!


Cleaning the bypass For cleaning excessive excessive contamination in the bypass, press the following buttons: h [More functions] >

[System] > [Wash [Wash & cleaning] > [Decontaminate all tubes]

Follow the instructions on the screen. e


For an exact description of the procedure, see Decontaminate the tubing paths on page page C-26 C-26!

June 2008 C-27

9 Maintenance

cobas b 121 system

Unscheduled

Cleaning the screen While in the "Analyzer" operating mode, press: h [More functions] > [System] >

[Wash [Wash & clean] > [Clean screen]

The keys on the screen are deactivated for 30 seconds. Clean only with a moist cloth (for example, one that is soaked with disinfectant). Do not use sprays!

After 30 seconds, the display changes back into its active condition.

Surfaces Do not attempt to decontaminate any par t of the instrument before shutting it down and unplugging it from the power source. ATTENTION

Before plugging the instrument back in and turning it on, always wait 15 minutes to allow the disinfectant to evaporate – Danger of fire and explosion! For safety reasons, only authorized technical support personnel may decontaminate the power pack!

Regularly decontaminate all outside surfaces of the instrument, including all covers (for example, printer cover, bottle compartment cover, top cover). For these tasks, use the decontaminant in accordance with local regulations. Very dirty surfaces should first be cleaned with w ith swabs or paper towel of gauze that have been soaked in distilled distil led water. Spray all removable covers (top cover, cover, bottle compartment cover) with surface disinfectant and then wipe them down with swabs or paper towel of gauze. Allow some time for solutions to soak for proper cleaning effects.

Never spray parts that cannot be removed or that are inside the instrument! ATTENTION

Adjusting the screen While in the "Analyzer" operating mode, press: h [More

functions] > [System] > [Test] > [PC components] > [Touch screen]

Use this test function to test the functionality of the touch screen and to adjust the screen.



cobas b 121 system


Figure Figure C-29

By pressing the [Test] [Test] button, you can check if the entire (black) area is active as a touch-sensitive surface (see Figur Figuree C-30 C-30).

Figure Figure C-30

By pressing the [Calibrate] button, you can use a pencil or ot her pointed object (but which is not too hard, to avoid scratching the surface) to touch the white points in the upper left and lower right corners. After release, the instrument will accept the exact position. From this time on, the instrument will use the touched points to calculate the t he offset between the displayed pixels and the touch screen. After a point has been accepted, the arrow disappears. The point itself remains visible and active (pressing the position again re-establishes the point) (see Figure Figure C-31 C-31).

Figure Figure C-31

After leaving the window, the new correction values take effect. Roche Diagnostics Instructions for Use · Version 10.0

June 2008 C-29

9 Maintenance

cobas b 121 system

Additional maintenance procedures

Additional maintenance procedures procedures The maintenance work listed here must be conducted by customer service or fully qualified technicians only. The components have been tested during development of the device to identify worn parts. They must be replaced at the annual service to prevent potential malfunctions.

Annual maintenance Decontamination/cleaning :

Replace the following components:

o

Sample port module (incl. sample drip tray)

o

Screen

o

Surfaces

o

Tube paths

o

Pump tube

o

Needle seal

o

Sample port

o

Pump head

o

Measuring chamber tube set

o

Replace the entire tube system

Only for coba cobass b 121 systems with AutoQC module:

Test/check:


o

AutoQC needle

o

AutoQC washing port

o

AutoQC washing tube

o

Test the barometer value and calibrate if necessary

o

Fill level measurement – waste water bottle: check accuracy

o

Determine the FMS volume

o

Check cleaning counter

o

Carry out system calibration

o

Carry out quality qualit y control measurement with all 3 levels (low, normal, high)


cobas b 121 system

9 Maintenance Maintenance overview

Maintenance overview While in the "Analyzer" operating mode, press: h [More functions]

> [System] > [Tools] [Tools] > [Maintenance]

The overview shows a list of all maintenance entries.

Figure Figure C-32

The following warnings are default entries and can neither be deactivated nor modified: o

Annual service

o

Replace PP tubing

o

Decontaminate bottle compartment

o

Decontaminate sample port module

o

Decontaminate screen

o

Replace fill port holder

Upcoming services are displayed in "red" in the list. marks the service as performed. p erformed. The next cycle period is calculated.

marks the service as "skipped" in the instrument database.

is used to create an independent entry to be stored in the instrument database.


June 2008 C-31

9 Maintenance

cobas b 121 system

Maintenance scheduler

Maintenance scheduler Additional services can be added to the list in the menu. h [Setup] > [Times & intervals]

> [Maintenance scheduler]

starting with the top level of the analyzer mode. e


For the exact description, see the Reference Manual , chapter Setup!


Troubleshooting Troubleshooting

10

D

Troubl roublesh eshooti ooting ng . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3

June 2008

cobas b 121 system

10 Troubleshooting Table of contents

Troubleshooting Troubleshooting

In this chapter, all fault messages, their causes and remedies are described. These are also displayed directly on the instrument screen. All messages are arranged according to info number.

In this chapter

Chapter

10

Troubleshooting - general ......................................................... .......................... ............................................................. ................................. ... D-5 System stops ............................................................. ............................. .............................................................. ................................................... ..................... D-5 General information ........................................................... ............................. ............................................................. ................................... D-6 List of system stops ................................................................ .............................. ................................................................... ..................................... .... D-7 3001 Measuring chamber cover open ........................................................ ............................ ..................................... ......... D-7 3002 Bottle compartment compartment cover open ................................................... ....................... .......................................... .............. D-7 3003 Flap open ................................................................... ................................... ................................................................ .................................... D-8 3004 Analyzer error ..................................................................................... ....................................................... ....................................... ......... D-8 3005 Memory error ............................................................................. ................................................ .............................................. ................. D-8 3006 Temperature error .................................................. ................... ........................................................... ..................................... ......... D-8 3009 Conductivity cal. error ................................................................. ..................................... ........................................... ............... D-9 3010 AQC cover open ................................ .. .............................................................. .......................................................... .......................... D-9 3012 User system stop .................................................... .................... ................................................................ ...................................... ...... D-9 3013 Fluid pack switch ......................................................................... ............................................ ............................................. ................ D-9 3014 Fill level alarm ............................................................ ............................. ............................................................. .................................. D-10 3015 Waste container full ............................................................... .................................. ................................................. .................... D-10 3016 Waste container container switch .......................................................................... ........................................... ................................... .... D-10 3017 Pump cal. error ............................................................................ .............................................. ............................................ .............. D-11 3018 Sample detection failed .................................................... ..................... ........................................................ ......................... D-11 3019 Out of operation ............................................................................. ................................................ ........................................ ........... D-11 3020 Economy mode ......................................................... .......................... .............................................................. ................................... D-11 3023 Waste Container Container level undefined ....................................................... .......................... .................................... ....... D-12 3024 Flash memory full ........................................................ ......................... ............................................................ ............................. D-12 3025 PCMCIA memory full ....................................................... ........................... .................................................... ........................ D-12 3026 Data object error ....................................... ........ ........................................................... ................................................ .................... D-13 3028 Hardware error ...................................................................... ........................................ .................................................. .................... D-13 3029 Hardware error ...................................................................... ........................................ .................................................. .................... D-13 Roche Diagnostics Instructions for Use · Version 10.0

June 2008 D-3

10 Troubleshooting

cobas b 121 system

Table of contents

3070 Hardware error ...................................................................... ........................................ .................................................. .................... D-13 Electrode status ............................................................ ............................. ............................................................ ............................................. ................ D-14 Sensor status .......................................................... .......................... .............................................................. ............................................. ............... D-16

Roche Diagnostics D-4


cobas b 121 system

10 Troubleshooting Troubleshooting Troubleshooting - ge neral

Troubleshooting Troubleshooting - general general cobas s b 121 system, including tubing, waste container, fter use, components of the coba container, fill port, etc., contain biological fluids and represent therefore a possible infectious risk. Handle these components with care and according to regulations surrounding potentially infectious materials. Suitable protective equipment, like laboratory clothing, protective gloves, protective goggles and if necess ary 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 of splashes. Suitable disinfection and sterilisation procedures must be applied.

A diagnostics function is available to facilitate fault removal. Pressing this button lists suggestions for the fault removal. e

An exact description of this function can be found in the Reference manual in in chapter System, section Tools > Diag nostics!

System stops

System stops should be corrected as quickly as possible! ATTENTION

For example:

Figur Figure e D-1


June 2008 D-5

10 Troubleshooting

cobas b 121 system

System stops

General information During situations when the proper function of the analyzer is not possible, System stops are displayed on the screen. The purpose is to display the errors, to remove the cause of the System stops and to bring the analyzer back to "Ready". A stop of all running actions will occur if danger for the user (e.g. by an overflow of the waste while opening the docking mechanism of the waste container) or for the analyzer exists or the proper operation of the analyzer is not possible because of technical problems. If proper operation is not possible, but the complete control of the functions of the analyzer is available (e.g. temperature alarm, measuring chamber cover open, flap open, fill level alarm) all running actions will be finished and Mix 1 will be aspirated into the measuring chamber; the resulting measuring data will be marked resp. discarded. Unrecoverable Unrecoverable System stops remain on the screen and fulfill an emergency program if possible, so that the analyzer stays operating (wetting of the electrodes / keeping the tubing free). It is possible to access the menu "System" if no automatic act ions are currently performed. When changing to the menu "System" during a "System stop", the "System stop" will not be b e terminated, but reactivated when the menu "System" is closed again. If e.g. there is a change from a "Temperature "Temperature system stop" to the menu "System" and the menu "System" is closed again, the analyzer will display the system stop "Temperature" "Temperature" again. In the case a system calibration has been started in the menu "System", it can not be conducted immediately because the "system stop" has to be removed first. After all "system stops" have been removed, "system stop consequence actions" will be executed. There is a common list of consequence actions, which impedes double actions. This means that if e.g. "washing" was activated several times, it is i s then performed only once. Possible consequence actions are:


o

Warm-up

o

Sample sensor calibration

o

Prepare solution C1

o

Prepare solution C2

o

Prepare Pack C3 solutions

o

Fill the AutoQC wash tube

o

Fill the FMS reservoir

o

Wash

o

Wash AutoQC

o


o

System calibration

o

Waste container fill level l evel measurement

o

Aspirate Mix1


cobas b 121 system

10 Troubleshooting List of system stops

List of system stops 3001 Measuring chamber cover open Cause

Remedy h

Consequence actions

o

The measuring chamber cover is open

o

The measuring chamber cover sensor (hall sensor) is defective

o

The measuring chamber cover cable is defective

o

Close measuring chamber cover

o

Check the measuring chamber cover sensor (

[More functions] > [System] > [Test] > [Control sensors] > [Monitoring sensors] o

Check cable

o

In case of recurrence, call technical support.

o

After opening for longer than 5 seconds: Warm-up Warm-up

o

Wash

o

After changing (an) electrode(s): system calibration

3002 Bottle compartment cover open Cause

Remedy

h

Consequence actions


o

The bottle compartment is open

o

The bottle compartment cover micro switch is defective

o

Close bottle compartment cover

o

Check to be sure that the bottles bottl es are inserted completely

o

Check the bottle compartment cover micro switch


In case of recurrence, call technical support

o

C1 changed: prepare solution C1, fill FMS reservoir, conductivity calibration

o


o

C3 changed resp. C3 docking mechanism micro switch operated: prepare C3 solutions

o

Waste container changed resp. micro switch operated: Waste container fill level l evel measurement

June 2008 D-7

10 Troubleshooting

cobas b 121 system

List of system stops

3003 Flap open Cause

Remedy h

Consequence actions

o

The flap was opened: O

during a measurement

O

during a calibration

O

during another system stop

O

in menu "System" and menu "System" is being closed

o

The flap detection is defective

o

Close flap

o

Check function of the flap detection board



o

Wash

o

The measurement progress was incorrect

o

Press the [OK] button

o

Switch the analyzer off/on

o

In case of recurrence, call technical support (the electronics is defective).

o

Wash

o

Fundamental software functions can not be performed (memory problems, fil e system problems), the correct operation of the instrument can not be guaranteed

o

Press the [Reboot] button

o


3004 Analyzer error Cause Remedy

Consequence actions

3005 Memory error Cause

Remedy

3006 Temperature error Cause

Remedy


o

The module temperature is outside of the specified range:

o

Measuring chamber (left and right): 37.00 °C ± 0.2 °C

o

Measuring chamber cover: cover: 37.00 °C ± 0.2 °C

o

tHb-/SO2 module: 37.00 °C ± 0.2 °C

o

A heating device is defective

o

The measuring chamber cover cable is defective defect ive

o

A temperature sensor is defective

o

Reduce / raise the room temperature

o

In case of recurrence, call technical support. June 2008 Instructions for Use · Version 10.0

cobas b 121 system


3009 Conductivity cal. error Cause Remedy

Consequence actions

o

The conductivity calibration has failed

o

Press the [OK] button (start a system calibration)

o


o

System calibration

o

The AutoQC cover is open

o

The AutoQC cover sensor (Hall sensor) is defective

o

Close the AutoQC cover

o

Check the AutoQC cover sensor

3010 AQC cover open Cause

Remedy h

[More functions] > [System] > [Test] > [Control sensors] > [Monitoring Sensors] o


o

The automatic fluidic procedure completion of some system stops can be interrupted by a User system stop (by pressing the [Stop] button), e.g. in order to get immediate access to the [More functions] button.

o

Press the [OK] button (terminate the "User system stop")

o


o

Aspirate Mix1

o

The docking mechanism of Fluid Pack C3 has been opened (micro switch activated)

o

The Fluid Pack C3 docking mechanism micro switch is defective

o

Close docking mechanism Fluid Pack C3

o

Check micro switch

3012 User system stop Cause

Remedy

Consequence actions

3013 Fluid pack switch Cause

Remedy h

Consequence actions




o

Auto-preparing Auto-preparing of Fluid Pack C3 solutions

June 2008 D-9

10 Troubleshooting

cobas b 121 system


3014 Fill level alarm Cause

Remedy

Consequence actions

o

The solutions C1, C2 and/or C3 are empty (below alarm level) or are set to "empty"

o

The Waste Waste container W is full (above alarm level) l evel)

o

The expiry date of the solutions is exceeded

o

The on-board lifetime of the solutions soluti ons is exceeded (C1/C2 = 28 days; C3 = 42 days)

o

Change solutions C1, C2 and Pack C3

o

Change or empty the Waste container W according to the instructions

o


o


o


o

C3 changed resp. C3 docking mechanism micro switch operated: prepare C3 solutions

o

Waste container changed resp. micro switch operated: Waste container fill level l evel measurement

3015 Waste container full o

Waste container is full

Remedy

o

Change or empty Waste container according to the instructions

Consequence actions

o


Cause

3016 Waste container switch Cause

Remedy h

Consequence actions


o

The Waste container (W) has been removed

o

The Waste container micro switch is defective

o

Reinsert the Waste container

o

Check Waste container micro switch



o



cobas b 121 system


3017 Pump cal. error Cause Remedy

h

o

The pump calibration (rotational speed adjustment of the pump) failed

o

Check PP tube

o

Check fill levels of solutions C1 and C2

o

Check under:

[More functions] > [Test] [Test] > [Valves [Valves & Aggregates] > [Peristaltic pump] if values inside the following limits are displayed:

Consequence actions

O

Pump volume: 40 - 70 μl

O

FMS volume: 920 - 1050 μl

o

If the displayed values are outside of the limit s, perform a FMS volume determination and correct the FMS volume value.

o


o

Aspirate Mix1

o


3018 Sample detection failed Cause

Remedy

Consequence actions

o

The sample detection with sample sensors (SS1 and SS2) failed

o

The sample sensor board is defective

o

Press the [OK] button (start a Sample sensor calibration)

o

Check fill level of solution C2

o


o

Sample sensor calibration

o

Fill FMS reservoir

o

Wash

o

The instrument has been taken out of operation operat ion

o

Perform the installation procedure

3019 Out of operation Cause Remedy

e

See Chapter 3 Installation and shutdown , section Installation on page A-21! A-21!

3020 Economy mode Cause Remedy


o

The economy mode has been started manually or automatically

o

Manual termination by pressing the [Abort] button

o

Automatic termination by preset stop time

June 2008 D-11

10 Troubleshooting

cobas b 121 system


3023 Waste Container level undefined Cause

Remedy

Consequence actions

o

The actually measured waste container fill level differs by more than 4 cm from the calculated/set value

o

The waste container fill level must be set roughly (+/- 4 cm) corresponding to the actual fill level in the t he waste container

o

Change the Waste Container W

o


o

Wash

o


o

The internal flash memory has less than t han 8 KB space left for saving additional data

o

Delete data records (database entries, protocols, log data) in order to free up additional memory

3024 Flash memory full Cause Remedy

e

See Chapter 8 Operating modes, section Database on page B-53 or B-53 or Reference Manual , chapter Setup, section Displays and reports!

In order to effectively free up additional memory, the functions "Delete data" and "Optimize database" have to be activated in this order. ATTENTION

3025 PCMCIA memory full full Cause Remedy

o

The PCMCIA card has less than 8 KB space spa ce left for saving additional data dat a

o

Delete data records from the PCMCIA card in order to free up additional memor y capacity.

data" and "Optimize In order to actually free up additional memory, the functions "Delete "Delete data" "Optimize database" database" have to be activated in this order ATTENTION

h

o

Insert the PCMCIA card in a PC with a suitable slot, copy or import the data, then delete the data from the card or format fo rmat the card

o

Format the PCMCIA card in the instrument.

[More functions] > [System] > [Test] [Test] > [PC [P C Components] > [PCMCIA card] > [More functions] e


See Reference Manual, chapter System section Test Test > PC Components > PCMCIA card !


cobas b 121 system


3026 Data object error Cause

Remedy

o

The data access onto objects in the analyzer a nalyzer area failed, the correct operation of the instrument can not be guaranteed

o

Press the [Reboot] button.

o


o

Internal bus system does not respond correctly

o

Wait! These errors are automatically self-repaired.

o


o

24 V supply voltage is not OK

o


o


o

Electronic components do not respond properly

o


o


3028 Hardware error Cause Remedy




June 2008 D-13

10 Troubleshooting

cobas b 121 system

Electrode status

Electrode status If a parameter is not ready (not calibrated), the symbol will be crossed out with grey and red lines (see below).

Figur Figure e D-2

After you press the parameter button, a status report will give you information about why the parameter could not be calibrated (see below). be low). e

The exact description of the short texts can be found in the Reference Manual , chapter Troubleshooting .

Figur Figure e D-3

Pressing this button lists suggestions for the fault removal (see below).

Figur Figure e D-4



cobas b 121 system

10 Troubleshooting Electrode status

Follow the instructions on the screen. Start automatic routines using this button.

Confirm actions performed with this button.

By using this button, this removal routine is aborted without action. After successful removal, the following screen appears:

Figur Figure e D-5 e


An exact description of this function can be found in the Reference Manual , chapter System, section Tools > Diag nostics!

June 2008 D-15

10 Troubleshooting

cobas b 121 system

Electrode status

Sensor status For additional information about the sensor status, press: h [Info] > [Sensor status]

Press [line up] / [line down] and select a sensor from the list on the t he left. The following information about the selected s elected sensor will be displayed:

Figur Figure e D-6

Pressing this button the printout of the report can be started.



Appendix

11

E

List List of of cons consuma umable bless . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

June 2008

cobas b 121 system

11 List of consumables Table of contents

List of consumables

In this chapter, all nessary consumables and order o rder numbers are listed.

In this chapter

Chapter

11

Order information ............................................................ ............................ .............................................................. .......................................... ............ E-5 Electrodes ............................................................... ............................... .............................................................. ................................................ .................. E-5 Solutions .............................................................. .............................. .............................................................. .................................................. .................... E-6 QC material ............................................................ ............................ ............................................................. ............................................... .................. E-6 Accessories ............................................................. ............................. .............................................................. ................................................ .................. E-7


June 2008 E-3

11 List of consumables

cobas b 121 system

Table of contents

Roche Diagnostics E-4


cobas b 121 system

11 List of consumables Order information

Order information To measure the respective parameter following products are required:

Electrodes Parameter Cl

-

+

+

2+

Na

K

Ca

P CO CO2

P O2

pH

tH b

S O2

Chloride Electrode 03111571180 (BP1729)

X

+

+

+

+

+

+

+

+

Sodium Electrode 03111598180 (BP1730)

+

X

+

+

+

+

+

+

+

Potassium Electrode 03111628180 (BP1731)

+

+

X

+

+

+

+

+

+

CalciumElectrode 03111644180 (BP1732)

+

+

+

X

+

+

+

+

+

CO2 Electrode P CO 03111679180 (BP1733)

+

+

+

+

X

+

+

+

+

P O 2 Electrode 03111695180 (BP1734)

+

+

+

+

+

X

+

+

+

pH Electrode 03111717180 (BP1735)

+

+

+

+

+

+

X

+

+

Reference Reference Electrode 03111873180 (BP2081)

X

X

X

X

X

X

X

X

X

MCon 03144062001 (BP2613)

X

X

X

X

X

X

X

X

X

SCon 03260909184 (BP2608)

X

X

X

X

X

X

X

X

X

Dummy Electrode (a ) 03111849035 (BP1959)

+

+

+

+

+

+

+

+

+

Tabelle Tabelle E-1 (a) Dummy or electrode has to to be used for proper proper filling of the measuring measuring chamber chamber


X

Has to be installed

+

Dummy or electrode has to be used for proper filling of the measuring chamber

June 2008 E-5


cobas b 121 system

Order information

Solutions Paramenter Cl-

Na+

K +

Ca2+

P CO CO2

P O2

pH

t Hb

S O2

C3 Fluid Pack 03144038001 (BP2655)

X

X

X

X

X

X

X

X

X

C1 Calibration Solution 03144046001 (BP2661)

X

X

X

X

X

X

X

X

X

C1 Calibration Solution 03144020001 (BP2662)

X

X

X

X

X

X

X

X

X

W Waste 03144054001 (BP2663)

X

X

X

X

X

X

X

X

X

Tabelle Tabelle E-2

Has to be installed

X

QC material Parameter Cl

-

+

+

2+

Na

K

Ca

P CO CO2

P O2

pH

tH b

S O2

AUTO-TROL TS+. Level 1 03321223001 (BP9106)

O

O

O

O

O

O

O

O

O


O

O

O

O

O

O

O

O

O


O

O

O

O

O

O

O

O

O

COMBITROLTS+. Level 1 03321258001 (BP9109)

O

O

O

O

O

O

O

O

O

COMBITROL TS+. Level 2 03321266001 (BP9110)

O

O

O

O

O

O

O

O

O

COMBITROLTS+. Level 3 03321274001 (BP9111)

O

O

O

O

O

O

O

O

O

TS/MSS Verification Material 03354601001 (BP9407)(a)

O

O

O

O

O

O

O

O

O

Tabelle Tabelle E-3 (a) Only for USA availa available! ble!

O


Can be used


cobas b 121 system

11 List of consumables Order information

Accessories Parameter Cl-

Na+

K +

Ca2+

P CO CO2

P O2

pH

tH b

S O2

Deproteinizer 03110435180 (BP0521)

O

O

O

O

O

O

O

O

O

Adapter for Capillaries 03069931001 (BP0959)

O

O

O

O

O

O

O

O

O

Ampoule Adapter 03066762001 (BP1938)

O

O

O

O

O

O

O

O

O

Clot Catcher 03112012180 (BP2243)

O

O

O

O

O

O

O

O

O

Cl-Cleaning Kit 03112098035 (BP2276)

O

-

-

-

-

-

-

-

-

Adapters for Sample Container 03112101180 (BP2277)

O

O

O

O

O

O

O

O

O

Caps for Roche MICROSAMPLER 03112152180 (BP2288)

O

O

O

O

O

O

O

O

O

Printer Paper 03113353180 (HP0070)

O

O

O

O

O

O

O

O

O

Roche MICROSAMPLER. non sterile 03113434035 (MC0015)

O

O

O

O

O

O

O

O

O

Roche MICROSAMPLER. sterile 03113442180 (MC0017)

O

O

O

O

O

O

O

O

O

Roche MICROSAMPLER. with accessories 03113663160 (US0600)(a)

O

O

O

O

O

O

O

O

O

Roche MICROSAMPLER. w/o. accessories 03113671160 (US0601)(b)

O

O

O

O

O

O

O

O

O

Capillary Tubes. ~ 200 μL 03113477180 (MC0024)

O

O

O

O

O

O

O

O

O

BS2 Blood Sampler 03113493035 (MC0028)

O

O

O

O

O

O

O

O

O

Capillary Tubes. ~ 115 μL 03113507035(MG0002)

O

O

O

O

O

O

O

O

O

Caps for Capillary Tubes 03113647035 (RE0410)

O

O

O

O

O

O

O

O

O

Customer Accessory Kit 04975600001

O

O

O

O

O

O

O

O

O

Tabelle Tabelle E-4 (a) Only for USA availa available ble (b) Only for for USA USA availabl availablee


O

Can be used

-

Do not use!

June 2008 E-7


cobas b 121 system

Order information



Index

12

F

Index Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3

June 2008

cobas b 121 system

Index

Index Numerics 1P calibration, B-39 1P calibration (1P cal), B-38 2P calibration (2P cal), B-38 2P calibration incl. O2, B-39 2P calibration without O2, B-40 2P O2 calibration, B-40

A Abbreviations, 8 Accessories, A-22 – List of consum consumables, ables, E-7 Adjusting the screen, screen, C-28 Analyzer mode, B-49 – "Ready" screen, B-49 – Database, Database, B-53 B-53 – Calibration Calibration data, B-57 – Data export, export, B-55 – Description of the buttons and their function, B-54 – Instrumen Instrumentt data, B-58 – Measuring Measuring data, B-57 – More functions of the database, B-54 – Patient Patient data, B-56 – QC data, B-58 – Info, Info, B-59 B-59 – QC measureme measurement, nt, B-52 – Quick access, access, B-51 – Setup, Setup, B-52 B-52 – System, System, B-51 B-51 Annual maintenance, C-30 Application area, A-10 Automatic calibrations, B-38 – 1P calibrat calibration ion (1P (1P cal), cal), B-38 – 2P calibrat calibration ion (2P (2P cal), cal), B-38 – Recalibratio Recalibration, n, B-38 – System calibration, B-38 AutoQC – AutoQC measurement, B-27 – Inserting AutoQC mats, B-21 – Material assignment, B-22 – Setting QC times, B-23

B Barcode scanner, A-18 – Specification Specifications, s, A-54 Bottle compartment, A-16 – Cleaning, Cleaning, C-17 C-17 Roche Diagnostics Instructions for Use · Version 10.0

Bottles – Insertion Insertion of bottles, bottles, A-30 – Remove Remove bottles, bottles, A-36 Brands, 1 Buttons, B-47 – Important buttons buttons on the screen, A-10 Bypass – Cleaning, Cleaning, C-27 C-27

C C1 calibration solution 1 – Exchang Exchange, e, C-10 C2 calibration solution 2 – Exchang Exchange, e, C-10 C3 fluid pack – Exchang Exchange, e, C-10 Calculated parameters, B-45 Calculated parameters at the t he patient’s temperature, B-46 Calibration, B-35 – Automatic calibrations, B-38 – 1P calibration (1P cal), B-38 – 2P calibration (2P cal), B-38 – Recalibrati Recalibration, on, B-38 – System System calibration, calibration, B-38 – Calibration progress indicator, indicator, B-37 – General, General, B-37 B-37 – User activated calibrations, B-39 – 1P calibration, calibration, B-39 – 2P calibration calibration incl. incl. O2, B-39 – 2P calibration calibration without without O2, B-40 – 2P O2 calibration, B-40 – Calibration for "Ready", B-39 – Conductivity Conductivity calibration, calibration, B-39 – System System calibration, calibration, B-39 Calibration data, B-57 Calibration for "Ready", B-39 Calibration procedure, A-12 Calibrations, A-50 Capillary mode, B-10 Capillary tubes, B-6 Check fill levels, C-7 Check printer paper, C-7 Checking the barometer value, value, A-26 Classification (according (according IEC/ISO), IEC/ISO), A-53 Clean needle and fill port, C-8 Cleaning the bottle compartment, C-17 Cleaning the bypass, bypass, C-27 Cleaning the drip tray tray and wash plate, C-17 Cleaning the measurement measurement chamber, chamber, C-25 June 2008 F-3

Index

Cleaning the screen, screen, C-28 Clot catcher, B-6 COM 1, A-17 COM 2, A-17 Conductivity calibration, B-39 Consumable list, E-3 – Accessori Accessories, es, E-7 – Electrodes, Electrodes, E-5 – QC material, material, E-6 – Solutions, Solutions, E-6 Contact addresses, 2 Copyright, 1 Counter overview, B-60

cobas b 121 system

– Replacement of the electrodes and the MCon, MCon, C-20 – Sensor Sensor status, status, D-16 – Temperature / humidity / stability, A-51 – Troubleshooting, D-14, D-16 Empty the waste container, container, C-13 Environmental parameters, A-51 – Temperature / humidity / stability, A-51 Exchanging the fill port holder, holder, C-15 Exchanging the solutions, C-10 – C2 calibrati calibration on solution solution 2, C-10 – C3 fluid pack, C-10

F D Data export – Database, Database, B-55 B-55 Data input – Measuring pocedure, B-12 Database, B-53 – Calibration Calibration data, B-57 – Data export, B-55 – Description of the buttons and their function, B-54 – Instrument Instrument data, B-58 – Measuring Measuring data, B-57 – More functions of the database, B-54 – Patient Patient data, B-56 – QC data, B-58 Decontamination, A-13, C-5 – Decontaminate the surfaces, C-28 – Decontaminate the tubing paths, C-26 – Recommended decontaminant, C-6 – Sample port module, module, C-5 – Surfaces of the instrument, C-6 – Touch screen, C-6 – Tubing paths, C-6 Default and input values, A-49 Dimensions, A-53 Disposal of waste water, bottles, electrodes, and the instrument, A-13 Document information, 1 Drip tray – Cleaning, Cleaning, C-17 C-17

E Edition, 2 Edition notice, 1 Electrodes – Handling Handling electrodes, electrodes, A-14 – Insert Insert electro electrodes, des, A-32 – Insertion of of the reference electrode, A-33 – List of consum consumables, ables, E-5 Roche Diagnostics F-4

Fill levels, B-59 – Check Check fill fill levels levels,, C-7 Fill port – Clean fill port, C-8 – Remove needle and fill port, A-40 Fill port holder – Exchang Exchange, e, C-15 Flap, A-16

G General description, A-7 General notes, A-10

H Help, B-59 How to Use This This Manual, 5

I Important information, A-5 Info, B-59 – Counter overview, B-60 – Fill levels, levels, B-59 – Help, Help, B-59 B-59 – Roche Roche info, info, B-59 – Sensor Sensor status, status, B-60 – Version numbers, B-59 Input parameters, B-46 – Measurement Measurement information, B-45 – Patient Patient information, information, B-44 Installation, A-21, A-22 – Accessori Accessories, es, A-22 – Attach power power cord and barcode scanner, scanner, A-22 – Attach Attach pump pump tube, A-28 – AutoQC AutoQC module, module, A-27 – Begin installation routines, A-35 June 2008 Instructions for Use · Version 10.0

cobas b 121 system

– Check tubes at V2 and V9, V9, A-26 – Check/Activate the parameters tHb and and SO2, A-25 – Checking the AutoQC module, A-26 – Checking the barometer barometer value, A-26 – Insert Insert electro electrodes, des, A-32 – Insert Insert FMS FMS tubes, tubes, A-27 – Insert needle needle and fill port holder, A-28 – Insertion Insertion of bottles, bottles, A-30 – Insertion of printer printer paper, A-29 – Insertion of of the reference electrode, A-33 – Installing the AutoQC module, A-23 – Location, Location, A-21 A-21 – Quality control, control, A-35 – Select language, language, A-25 – Setting the date date and and time, A-25 – Switch Switch on, A-25 Installation and and shutdown, shutdown, A-19 Instructions for Use – Abbreviation Abbreviations, s, 8 – Conventions Conventions used in this manual, 5 – How to use, 5 – IVD symbols, symbols, 6 – Operating safety information, A-6 – Other symbols, symbols, 7 – Symbols Symbols,, 5 – Where to find information, 5 Instrument – Temperature / humidity / stability, A-51 Instrument data, B-58 Interface, A-17 – Barcode scanner, scanner, A-18 – COM 1, A-17 – COM 2, A-17 Introduction, A-9 IVD symbols, 6

Index

List of consumables, E-3 – Accessori Accessories, es, E-7 – Electrodes, Electrodes, E-5 – QC material, material, E-6 – Solutions, Solutions, E-6 List of system stops, stops, D-7 Location, A-21

– Check printer paper, C-7 – Decontamina Decontamination, tion, C-5 – General, General, C-5 – Maintenance Overview in the the software, software, C-31 – Maintenance scheduler, scheduler, C-32 – Sample-dependent maintenance procedures, C-10 – Exchanging the fill port holder, holder, C-15 – Exchanging the solutions, C-10 – Waste material, C-12 – Semi annual, annual, C-9 – Replacement of the peristaltic pump tubes, C-9 – Unsched Unscheduled, uled, C-17 – Adjusting the screen, C-28 – Cleaning the bottle compartment, C-17 – Cleaning Cleaning the bypass, bypass, C-27 – Cleaning the drip tray and wash plate, C-17 – Cleaning the measurement measurement chamber, chamber, C-25 – Cleaning the screen, C-28 – Decontaminate the surfaces, C-28 – Decontaminate the tubing paths, C-26 – Removing obstructions, C-25 – Replacement of the electrodes and the MCon, MCon, C-20 – Replacement of the reference electrode, C-23 – Replacing printer paper, C-19 – Weekly, C-8 – Clean needle and fill port, port, C-8 Manual QC measurement, B-26 Measured parameters, B-45 Measurement, B-3 – Preanalytic Preanalytics, s, B-5 Measurement Measurement and calibration procedure, procedure, A-12 – Calibration procedure, A-12 – Measurement Measurement evaluation, A-12 – Measurement Measurement procedure, A-12 Measurement chamber, A-16 – Cleaning, Cleaning, C-25 C-25 Measurement evaluation, A-12 Measurement Measurement procedure, procedure, A-12 Measurement report, B-13 Measuring data, B-57 Measuring pocedure, B-8 – Capillary Capillary mode, B-10 – Data input, B-12 – Results display / measurement measurement report, B-13 – Syringe Syringe mode, B-9 Multirules, B-28

M

N

Maintenance, C-3 – Additional maintenance procedures, C-30 – Annual maintenance, C-30 – Annual maintenance, C-30 – Daily, Daily, C-7 – Check Check fill fill levels levels,, C-7

Needle – Clean needle, needle, C-8 – Remove needle and fill port, A-40

L


June 2008 F-5

Index

O Obstructions – Removing Removing obstructions, obstructions, C-25 Operating instructions, A-10 Operating modes, B-41 – Analyzer Analyzer mode, B-49 – Database, Database, B-53 B-53 – Info, Info, B-59 B-59 – QC measureme measurement, nt, B-52 – Quick access, access, B-51 – Setup, Setup, B-52 B-52 – System, System, B-51 B-51 – General, General, B-43 B-43 – Software overview, B-61 – User Interface, B-43 Operating safety information, A-6 Operation – Calibration, Calibration, B-35 B-35 – Measurem Measurement, ent, B-3 – Quality Quality control, control, B-15 Operator’s Manual – version, version, 1 Order information, E-5 – Accessori Accessories, es, E-7 – Electrodes, Electrodes, E-5 – QC material, material, E-6 – Solutions, Solutions, E-6

P Parameter, B-44 – Additional calculated parameters, B-46 – Calculated Calculated parameters, parameters, B-45 – Calculated parameters at the patient’s patient’s temperature, B-46 – Input Input paramete parameters, rs, B-46 – Input parameters - measurement measurement information, B-45 – Input parameters - patient information, information, B-44 – Measured parameters, B-45 – Parameter appearance on the "Ready" screen, B-44 Patient data, B-56 Performance data, A-47 – Measured parameters, A-47 Plasma – Sample handling, handling, B-7 Power supply, A-16 Preanalytics, B-5 – Sample collection collection,, B-5 – Sample collection containers, B-6 – Sample handling, handling, B-7 Preface, 5 Printer, A-15 – Check printer paper, C-7 – Replacing printer paper, C-19 Roche Diagnostics F-6

cobas b 121 system

– Specification Specifications, s, A-53 Product data, A-53 – Classification (according IEC/ISO), A-53 – Dimensions Dimensions,, A-53 – Electrical Electrical data, A-53 – Weight, A-53 A-53 Pump, A-16 – Remove the pump tube, A-39 – Replacement of the peristaltic pump tubes, C-9

Q QC concept – General, General, B-17 B-17 QC consequences, B-30 QC data, B-58 QC error, B-31 QC material – List of consum consumables ables,, E-6 – Material Material setup, setup, B-20 – Inserting AutoQC mats, B-21 – Material assignment - AutoQC AutoQC materials, materials, B-22 – Setting Setting QC QC times, times, B-23 – Temperature / humidity / stability, A-52 QC measurement, B-26, B-52 – AutoQC measurement, B-27 – Manual QC measurement, B-26 QC troubleshooting, B-32 QC unlock, B-31 – QC error, error, B-31 – QC warning, warning, B-31 QC warning, B-31 Quality control, B-15 – General, General, B-17 B-17 – General QC concept, B-17 – Important information concerning concerning the analysis of QC measurement measurement results, B-19 – Material Material setup, setup, B-20 – Inserting AutoQC mats, B-21 – Material assignment - AutoQC AutoQC materials, materials, B-22 – Setting Setting QC QC times, times, B-23 – Multirule Multirules, s, B-28 – QC consequences, B-30 – QC measuremen measurement, t, B-26 – AutoQC measurement, B-27 – Manual QC measurement, B-26 – QC troubleshooti troubleshooting, ng, B-32 – QC unlock, unlock, B-31 – QC error, error, B-31 – QC warning, warning, B-31 Quick access, B-51


cobas b 121 system

R Ready screen, B-49 Recalibration, B-38 Reference Reference electrode – Replaceme Replacement, nt, C-23 Remove needle and fill port, A-40 Remove the electrodes, A-39 Remove the printer paper, paper, A-40 Remove the waste container (W waste container), C-12 Removing obstructions, C-25 Replacement of the the electrodes and the MCon, C-20 Replacement of the peristaltic pump tubes, C-9 Replacement of the the reference electrode, C-23 Replacing printer paper, paper, C-19 Results display, B-13 Reverse side, A-17 – Interface, Interface, A-17 A-17 – Warning and identification labels, A-18 Revision history, 1 Roche info, B-59 Roche MICROSAMPLER ®, B-6

S Safety information, A-3 – Important Important information, information, A-5 Safety instructions for specific dangers, A-13 – Decontamin Decontamination, ation, A-13 – Disposal of waste water, water, bottles, electrodes, and the instrument, A-13 – Handling Handling electrodes, electrodes, A-14 – Handling Handling samples, samples, A-13 – Handling Handling solutions, solutions, A-13 Sample collection, B-5 – Acceptable Acceptable anticoagulants, B-5 measurement, B-5 – Especially Especially for tHb, tHb, SO2 and Hct measurement, – Sample acquisition acquisition,, B-5 Sample collection collection containers, containers, B-6 – Capillary Capillary tubes, B-6 – Clot catcher catcher,, B-6 – Roche Roche MICROSAMP MICROSAMPLER LER ®, B-6 – Syringes, Syringes, B-6 B-6 Sample handling, B-7 – Plasma, Plasma, B-7 B-7 – Serum, Serum, B-7 B-7 – Whole Whole blood, B-7 Sample port module – Decontamin Decontamination, ation, C-5 Sample throughput, A-49 Sample types, A-50 Sample volume, A-49 Samples – Handling Handling samples, samples, A-13 Scheduler Roche Diagnostics Instructions for Use · Version 10.0

Index

– Maintenance scheduler, scheduler, C-32 Screen, A-15 – Cleaning the screen, C-28 – Specification Specifications, s, A-54 Sensor status, B-60, D-16 Serum – Sample handling, handling, B-7 Setting QC times, B-23 Setup, B-52 Shutdown, A-19, A-36 – Insert the shutdown kit and connect it, A-37 – Less than 24 hours, hours, A-36 – Longer than 24 hours, A-36 – Remove Remove bottles, bottles, A-36 – Remove needle and fill port, A-40 – Remove the electrodes, A-39 – Remove the printer paper, A-40 – Remove the pump tube, A-39 – Remove the shutdown kit, A-38 – Remove the tube under under V1 and V2, A-41 – Remove the V2 and and V9 tube ends from the guides, A-37 – Remove the waste waste container container,, A-38 – Return the V2 and V9 tube ends to the guides, A-38 – Shutting down the AutoQC AutoQC module, A-41 – Uninstall the AutoQC module, A-42 Software – version, version, 1 Software overview, B-61 Solutions – Exchanging the solutions, C-10 – C1 calibration solution 1, C-10 – C2 calibration solution 2, C-10 – C3 fluid pack, C-10 – Handling Handling solutions, solutions, A-13 – List of consum consumables ables,, E-6 – Temperature / humidity / stability, A-52 Specifications, A-45 – Barcode scanner, scanner, A-54 – Calibrations Calibrations,, A-50 – Default and input input values, values, A-49 – nvironmental parameters, A-51 – Performan Performance ce data, A-47 – Printer Printer,, A-53 – Product Product data, A-53 – Sample throughput throughput,, A-49 – Sample types, A-50 – Sample volume, volume, A-49 – Screen, Screen, A-54 A-54 Surfaces – Decontamina Decontamination, tion, C-28 Surfaces of the instrument – Decontamina Decontamination, tion, C-6 Symbols, 5, 7 Syringe mode, B-9 Syringes, B-6 System, B-51 June 2008 F-7

Index

System calibration, B-38, B-39 System description, A-15 – Bottle compartmen compartment, t, A-16 – Flap, A-16 – Measurement Measurement chamber, chamber, A-16 – Power supply, A-16 – Printer Printer,, A-15 – Pump, Pump, A-16 A-16 – Reverse Reverse side, A-17 – Screen, Screen, A-15 A-15 System stops, D-5 – List of system system stops, stops, D-7

cobas b 121 system

W Warning and identification identification labels, A-18 Wash plate – Cleaning, Cleaning, C-17 C-17 Waste material, C-12 – Empty the waste container, container, C-13 – Installing the waste waste container, container, C-14 – Remove the waste container (W waste container), container), C-12 – Using the empty C1 calibration solution 1 bottle as W waste container, container, C-14 Whole blood – Sample handling, B-7

T Temperature / humidity / stability, stability, A-51 – Electrodes, Electrodes, A-51 A-51 – Instrument, Instrument, A-51 A-51 – QC material, material, A-52 – Solutions, Solutions, A-52 A-52 Touch screen – Adjusting the screen, C-28 – Decontamin Decontamination, ation, C-6 Troubleshooting, D-3 – Electrode Electrode status, status, D-14 – Sensor Sensor status, D-16 – General, General, D-5 – QC troubleshoot troubleshooting, ing, B-32 – System System stops, stops, D-5 – List of system system stops, D-7 Tubing paths – Decontamination, C-6, C-26

U User activated calibrations, B-39 – 1P calibration, calibration, B-39 – 2P calibration calibration incl. incl. O2, B-39 – 2P calibration calibration without without O2, B-40 – 2P O2 calibration, B-40 – Calibration for "Ready", B-39 – Conductivity Conductivity calibration, calibration, B-39 – System calibration, B-39 User interface, B-43 – Buttons, Buttons, B-47 B-47 – Parameter Parameter,, B-44

V Version numbers, B-59

Roche Diagnostics F-8


Instructions for Use Cobas b121 en[1]

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