Instructions For Use Cobas B 121 en Rev12 GRIPS

cobas b 121 system
Instructions for Use

COBAS, COBAS B and LIFE NEEDS ANSWERS
are trademarks of Roche.
©2011 Roche
Roche Diagnostics GmbH

D-68298 Mannheim
Germany
www.roche.com
cobas b 121 system
Revision History
Manual Version Software Version Revision date Changes

2.0 October 2001
3.0 1.2 January 2002
4.0 1.31 December 2002
5.0 1.60 December 2004
6.0 1.70 May 2005 English only!
7.0 1.71 Juni 2006 cobas branding
8.0 1.71 Juni 2006
9.0 1.72 May 2007
10.0 1.74 June 2008 Change of the template
11.0 1.75 March 2011 Not released
12.0 1.76 September 2011
Edition notice
cobas b 121 system

In the course of 2005 the Roche OMNI C system was rebranded under the Roche
professional IVD user brand cobas®.
Systems with a serial number of 5000 or above are cobas b 121 system.
Systems with a serial number up to 4999 are Roche OMNI C systems.
Intended Use
The cobas b 121 system is an analyzer for measuring blood gases, electrolytes, total
hemoglobin, oxygen saturation and hematocrit in whole blood, serum, plasma,
acetate and bicarbonate containing dialysis solutions, and QC materials.
This product complies with the requirements in the guideline for

In Vitro Diagnostic 98/79/EC
Copyright
© 2011, 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 its correctness. Roche Diagnostics assumes no
Roche September 2011

Instructions for Use · Version 12.0 3
cobas b 121 system
responsibility for errors or omissions which may appear in this document.

Subject to change without notice.
Brands
COBAS, COBAS B, COBAS BGE LINK, LIFE NEEDS ANSWERS, ROCHE OMNI,
AUTOQC, ROCHE MICROSAMPLER, COMBITROL and AUTO-TROL are
trademarks of Roche.
Contact addresses
Manufacturer Roche Diagnostics GmbH

D-68298 Mannheim / Germany
www.roche.com
Edition
Revision 12.0, September 2011

First edition: October 2001
REF/No. 03260992001

4 Instructions for Use · Version 12.0
cobas b 121 system
Table of contents
Revision History 3 6 Quality control

Edition notice 3 Quality control - general B-25
Intended Use 3 General QC concept B-25
Copyright 3 Important information concerning the
Brands 4 analysis of QC measurement results B-27
Contact addresses 4 Material setup B-28
Edition 4 QC measurement B-34
Table of contents 5 Multirules B-36
Preface 7 QC consequences B-38
How to use this manual 7 QC unlock B-38
Where to find information 7 QC troubleshooting B-39
Conventions used in this manual 7
7 Calibration
Calibration - general B-45
Introduction and specifications Part A
8 Operating modes
1 Safety information Operating modes - general B-51
Important information A-5 User interface B-51
Operating safety information A-6 Analyzer mode B-56
IT Security Advisory A-7 Software overview B-68
2 General description
Introduction A-11
Maintenance Part C
General notes A-12
Measurement and calibration procedure A-14 9 Maintenance
Safety instructions for specific dangers A-15 Maintenance - general C-5
System description A-17 Decontamination C-5
Daily C-7
3 Installation and shutdown Weekly C-8
Installation A-23 Semi annual C-9
Shutdown A-38 Sample-dependent maintenance procedures C-10
Unscheduled C-17
4 Specifications Additional maintenance procedures C-29
Performance data A-47 Maintenance overview C-30
Default and input values A-49 Maintenance scheduler C-31
Sample throughput A-49
Measurement times of the samples A-49
Sample volume A-50
Troubleshooting Part D
Sample types A-50
Calibrations A-50 10 Troubleshooting
Environmental parameters A-51 Troubleshooting - general D-5
Product data A-53 System stops D-5
Printer A-53 List of system stops D-7
Screen A-54 Electrode status D-14
Barcode scanner A-54
Appendix Part E
Operation Part B
11 List of consumables
5 Measurement Order information E-5
Preanalytics B-5
Interferences B-9
Measuring procedure B-17
cobas b 121 system
Index Part F
Index F-3

cobas b 121 system
Preface
This manual has detailed descriptions of cobas b 121 system features and general
operational concepts, specification functions and use of controls, 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 the end.
Where to find information
In addition to the Instructions for Use, the following documents are also provided to
assist in finding desired information quickly:
o cobas b 121 system Reference Manual
o cobas b 121 system Short Instruction
Conventions used in this manual
Visual cues are used to help locate and interpret information in this manual quickly.
This section explains formatting conventions used in this manual.
Symbols Helping to locate and interpret information in this manual the following symbols are
used:
Symbol Description
a Procedural step
o List item
e Cross-reference
h Call up of screen
Note

cobas b 121 system
Symbol Description
Attention
All sections / passages that are marked with this symbol describe
procedures and/or indicate conditions or dangers that could damage
or lead to a malfunction in the cobas b 121 system.
Warning
Sections marked with this symbol contain information that 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 symbols are used in accordance with DIN EN 980(a) and DIN EN ISO 780(b).
Symbol Description
Conformité Européenne:
This product complies with the requirements in the guideline for
In Vitro Diagnostic 98/79/EC.
Batch code
Use by...
The product should not be used after expiry of the specified date.
If a day is not indicated, apply the last day of the respective month.
Temperature limitation
The conditions necessary to preserve the product's shelf life before
opening.
In Vitro Diagnostic Medical Device
Manufacturer — according to In Vitro Diagnostic guidelines 98/79/EG
Catalogue number
Attention, consult accompanying documents
Please consult instructions for use
Serial number (model plate)
(a) DIN EN 980: Medical devices - Symbols to be used with medical device labels, labelling and information
to be supplied (Part 1: General requirements)
(b) DIN EN ISO 780: Packaging - Pictorial marking for the handling of goods

cobas b 121 system
Symbol Description
Do not use if package damaged
Do not reuse
Fragile. Handle with care
Handle with care
Keep dry
Valid only for Roche MICROSAMPLER PROTECT:

Method of sterilization using ethylene oxide
Valid only for BS2 Blood Sampler:
Method of sterilization using irradiation
Biological risk!
(according to the standard IEC/EN 61010-2-101)(a) (Instrument)
Biological risk!
(according to the standard DIN EN ISO 980)(b) (Consumables)
(a) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control, and
laboratory use - (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment).
(b) DIN EN ISO 980: Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied (Part 1: General requirements).
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 Pack)
Rating: Although not corrosive, momentary, longer-lasting, or
repeated contact with skin or mucous membrane may result in
inflammation. Danger of sensitization during contact with
skin (when classified with R 43).
Caution: Avoid contact with eyes and skin, do not inhale
vapors.

cobas b 121 system
Symbol Description
"Grüner Punkt" (in Germany)
Store upright
Protective gloves, protective goggles and suitable protective

clothing must be worn.
Abbreviations The following abbreviations are used:
Abbreviation Definition
A
ANSI American National Standards Institute
AQC Automatic Quality Control
B
BG Blood gas
C
CE Conformité Européenne (European Conformity)
CLIA Clinical Laboratory Improvement Amendments
CLSI Clinical and Laboratory Standards Institute
cond Conductivity
CSA Canadian Standards Association
C1 Calibration Solution 1
C2 Calibration Solution 2
C3 Fluid Pack
D
dBA Decibel weighted against the A-frequency response curve. This curve
approximates the audible range of the human ear.
DIL Diluent
DNS Domain Name Server
E
EC European community
e.g. exempli gratia – for example
EN European standard
F
FMS Fluid mixing system
H
Hct Hematrocrit
HIV Human immunodeficiency virus
HW Hardware
I
i.e. id est – that is to say
ISE Ion selective electrode

cobas b 121 system
Abbreviation Definition
IVD In vitro Diagnostic Directive
L
LCD Liquid cristal display
LIS Laboratory Information System
LJ Levey Jennings
M
MAC Media Access Control
MC Measuring chamber
MCon Measuring contact
MV Mean value
N
NIST National Institute of Standards and Technology
NRTL Nationally Recognited Testing Laboratory
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
e For writing the measuring, calculated and input values see Chapter 8 Operating modes,
section Parameter on page B-69!

cobas b 121 system

Introduction and specifications A
1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 General description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
3 Installation and shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
4 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-45
September 2011
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
IT Security Advisory ................................................................................................... A-7
Description ...................................................................................................... A-7
Security precautions ........................................................................................ A-7

Instructions for Use · Version 12.0 A-3
1 Safety information cobas b 121 system
Table of contents

A-4 Instructions for Use · Version 12.0
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 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 service
personnel.
Only accessories and supplies either delivered by or approved by Roche are to be used
with the instrument. These items are manufactured especially for use with this
instrument and meet the highest quality requirements.
Operation of the instrument with solutions whose composition is not consistent with
that of the original solutions can negatively affect the long-term measurement
accuracy. Deviations in the composition of the solutions can also decrease the service
life of the electrodes.
In order to ensure the quality of the measurement results, complete a quality control
test on 3 levels (1 = low, 2 = normal, 3 = 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 level between two automatic
2P calibrations. The levels have to be alternated (1 = low, 2 = normal, 3 = high).
Since the measurements of the instrument depend not only on the correct
characteristic function, but also on a series 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.
Please refer to safety-related notes in the manual accompanying this instrument.

ATTENTION

Operating safety information
Operating safety information
The instrument has been constructed and tested according to the following European
Standards:
o IEC/EN 61010-1(a)
o IEC/EN 61010-2-101(b)
o IEC/EN 61010-2-081(c)
It was delivered from the factory in flawless condition with regards to safety features.
In order to preserve this condition and ensure safe operation, the user must respect
the notices and warnings that are contained in these Instructions for Use.
o This instrument is classified under the protection class I according to
IEC/EN 61010-1.
o The instrument meets the conditions for overvoltage category II.
o The instrument meets the conditions for contamination level 2.
o Do not operate the instrument in an explosive environment or in the vicinity of
explosive anesthetic mixtures containing oxygen or nitrous oxide.
o If objects or liquids enter the internal areas of the instrument, remove 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 indoors.
o The power cord must be plugged into a grounded power receptacle. When using an
extension cord, make sure it is properly grounded.
WARNING o Any rupture of the ground lead inside or outside the instrument or a loose ground
connection may result in hazardous operating conditions for the operating personnel.
Intentional disconnection of the grounding is not permitted.
o The instrument is not suitable for operation with a direct current power supply.
o Use only the original power plug delivered with the cobas b 121 system.
(a) IEC/EN 61010-1: Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 1: General requirements)
(b) IEC/EN 61010-2-101: Safety requirements for electrical equipment for measurement, control, and
laboratory use (Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment)
(c) IEC/EN 61010-2-081: Safety requirements for electrical equipment for measurement, control and
laboratory use (Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes)

IT Security Advisory
Description
All devices based on common off-the-shelf operating systems (Microsoft Windows,
Linux, etc.) with the capability to connect external storage devices (USB memory
drives/sticks, hard disks, floppy disks, CD-ROM, DVS, cameras, PDA, wireless
communication devices, etc.) are concerned. This usually applies but is not limited to
all products which come with a PC or notebook.
External storage media can be infected with and transmit computer malware (e.g.
Virus, Trojan Horse, Spyware, etc.)
cobas b 121 system does not contain anti-virus protection software. Therefore, it is
essential to follow the necessary precautions listed below to prevent the transmission
of malware.
Security precautions
Failure to observe the following recommendations may result in data loss, loss of integrity
of patient results or unavailability of the system, which may put patients at risk.
ATTENTION
o Check all external storage devices with an anti-virus program (on another PC) to
ensure that they are malware free before using them on the system.
o Recheck the external storage device between use on different systems in order to
avoid cross-interference.
o Keep all external storage devices in a secure place so that they can be accessed only
by authorized personnel.
o Do not add, move or delete any files or software unless stated in
cobas b 121 system-specific documentation.
o Never copy and install any non-Roche software on the system.
o If a system requires additional software please contact the appropriate system
hotline.
o Use any remote services capability (e.g. cobas® e-support) only to connect to the
Roche Service Network.
o Do not connect to the Internet unless stated in cobas b 121 system-specific
documentation.
o Make sure only validated computers are connected to the instrument system
network.
o Ensure other computers on attached networks (e.g. the LIS, FTP) are properly
secured and protected from malware. This is the responsibility of the customer
and their IT specialists.
o The use of a cobas IT firewall is strongly recommended or even mandatory
depending on the system installation.


cobas b 121 system 2 General description
Table of contents
General description
This chapter contains a general description of the instrument, as well as

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

Introduction .............................................................................................................. A-11
General notes ............................................................................................................. A-12
Application area ................................................................................................... A-12
Operating instructions ........................................................................................ A-12
Important buttons on the screen ........................................................................ A-12
Measurement and calibration procedure ................................................................. A-14
Measurement procedure ..................................................................................... A-14
Calibration procedure ......................................................................................... A-14
Measurement evaluation ..................................................................................... A-14
Safety instructions for specific dangers .................................................................... A-15
Handling samples ................................................................................................ A-15
Disposal of waste water, bottles, electrodes, and the instrument ..................... A-15
Decontamination ................................................................................................ A-15
Handling solutions .............................................................................................. A-15
Handling electrodes ............................................................................................ A-16
System description .................................................................................................... A-17
Visual identification ............................................................................................ A-17
Screen ................................................................................................................... A-17
Printer .................................................................................................................. A-17
Measurement chamber ........................................................................................ A-18
Pump .................................................................................................................... A-18
Flap ....................................................................................................................... A-18
Bottle compartment ............................................................................................ A-18
Power supply ........................................................................................................ A-18
Position of the power switch ......................................................................... A-18
Reverse side .......................................................................................................... A-19
Interface ......................................................................................................... A-19
2 General description cobas b 121 system
Table of contents
Barcode scanner ............................................................................................. A-19

Warning and identification labels ................................................................. A-20

Introduction
Introduction
Figure A-1
The cobas b 121 system is a modular analyzer for measuring blood gases, electrolytes,
total hemoglobin, oxygen saturation and hematocrit in whole blood, serum, plasma,
acetate and bicarbonate containing dialysis solutions, and QC materials.
It is possible to complete database procedures or to make simultaneous 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 Database: data about patients, measurement, calibration, QC, and the instrument
o Setup: instrument settings
o Info: Roche info, version number, fill levels, help, sensor report
The instrument is currently available in the following configuration:

o BG (pH, PO2, PCO2) / ISE (Na+, K+, Cl–, Ca2+) and tHb/SO2
A new fluid calibration system eliminates the need for expensive calibration gases.
This change results in easier handling, a smaller footprint, and reduced costs.
An easily understood "Touch Screen" interface facilitates easy operation and saves
costly and time-consuming user training.
The patented electrodes are completely maintenance-free, and only require a very
small sample volume.

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.
In order to achieve accurate measurements of recommended aqueous control
solutions (with regards to deviations from 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 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.

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

General notes
Buttons Description
Confirm
Cancel
Activate / deactivate
Start action
e For more information, see Chapter 8 Operating modes, section Buttons on page B-54!

Measurement and calibration procedure
Measurement and calibration procedure
Measurement procedure
Use the following methods are used to determine the various measurement variables:
PO2 : Use of the Clark measurement principle: measurement of current generated by
the reduction of oxygen
PCO2 : Use of the Severinghouse principle: potentiometric measurement of the pH
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 in whole blood is measured at four different 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 measurement results that are output by the cobas b 121 system must always be
checked for plausibility by medical specialists with consideration of the clinical situation of
WARNING the patient before a clinical decision is made based on the results.
e For more information, see Chapter 6 Quality control!

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 risk when handling items that were in
contact with biological samples.
Roche recommends following a decontamination procedure in addition to
regulations specific to the laboratory.
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, see Chapter 9 Maintenance!
Handling solutions
Store the instrument solutions according to the specified packaging requirements.

The solutions should be adapted to the ambient temperature before use.
The shelf life of the solutions is limited.
Please read the bottle label and the packaging for the correct storage temperature and
the maximum shelf life.
DO NOT FREEZE!
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!

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.
IMPORTANT! Installation note for the PCO2 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 PCO2 electrode during
storage is found inside the ALU-PE packaging.
This gas atmosphere ensures immediate potential stability during insertion of the electrode
into the measurement chamber and/or immediate readiness for measuring after the
2P calibration is completed.
If more than 5 minutes elapse after opening the ALU-PE packaging, the level of gas
conditioning could be lost and the time required for the first-time calibration could be
increased.

System description
System description
Visual identification
A J
I
B
H
C G
D
E
A Printer cover F AutoQC module (option)

B Pump G Measurement chamber with the electrodes
C Power pack / main switch and tHb/SO2 module
D Unlocking knob for the AutoQC module H Flap
E Bottle compartment I Contrast setting
J Screen
Figure A-2
Screen
All information (results, error messages, warnings, etc.) is displayed on the screen.
The screen consists of a 5.7" colour LCD that is covered with a touch-sensitive film
("touch screen").
Printer
The low-noise 2" thermal printer with integrated paper cutter for roll paper is located
underneath the printer cover.

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 locking 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 MICROSAMPLER PROTECT]
Bottle compartment
The calibration solutions and the waste container are located behind the bottle
compartment cover.
Power supply
This unit contains the power switch and the power connector.
Position of the power switch
Power switch "OFF" Power switch "ON"
Figure A-3

System description
Reverse side
Interface
A B C D
A COM 1 C Barcode Scanner

B COM 2 D Network connection
Figure A-4
COM 1* RS 232 Schnittstelle

COM 2* RS 232 Schnittstelle
Barcode PS/2 DIN - 6p Buchse
Network 10BaseT Ethernet (RJ45)
*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 For an exact description of the assignment, see Reference Manual chapter Setup, section
Interfaces > COM 1.
COM 2 This interface can be assigned as serial interface to ASTM.

e For an exact description of the assignment, see Reference Manual chapter Setup, section
Interfaces > COM 2.
Barcode scanner
Figure A-5
o Scanning of solution data (type, lot number, expiration date current composition,
etc.)
o Scanning of electrode data (type, lot number, expiration date)
System description
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
For further information, see the enclosed manual for the PS2 hand-held scanner (included
in scope of delivery).
Warning and identification labels
Figure A-6 Identification label
A Identification label
Figure A-7

cobas b 121 system 3 Installation and shutdown
Table of contents
Installation and shutdown
In this chapter, the software-guided installation and shutdown of the instrument are
described step by step. The sequence of the steps described must be strictly followed.

Installation ................................................................................................................. A-23
Location ............................................................................................................... A-23
Accessories ........................................................................................................... A-24
Installation ........................................................................................................... A-24
1. Attach power cord and barcode scanner .................................................. A-24
2. Installing the AutoQC module (Automatic Quality Control Module) .. A-25
3. Switch on .................................................................................................... A-27
4. Select language ........................................................................................... A-27
5. Setting the date and time .......................................................................... A-27
6. Check/Activate the parameters tHb and SO2 ........................................... A-27
7. Checking the barometer value .................................................................. A-28
8. Checking the AutoQC module ................................................................. A-28
9. Installation ................................................................................................. A-28
10. Check tubes at V2 and V9 ....................................................................... A-28
11. Insert FMS tubes (Fluid Mixing System) ............................................... A-29
12. AutoQC module (option) ....................................................................... A-29
13. Attach pump tube .................................................................................... A-29
14. Insert needle and fill port holder ............................................................ A-30
15. Insertion of printer paper ....................................................................... A-31
16. Insertion of bottles .................................................................................. A-32
17. Insert electrodes ....................................................................................... A-34
18. Insertion of the reference electrode ........................................................ A-35
19. Begin installation routines ...................................................................... A-37
20. Quality control ........................................................................................ A-37
Shutdown ................................................................................................................... A-38
Less than 24 hours ............................................................................................... A-38
Longer than 24 hours .......................................................................................... A-38
1. Remove bottles ........................................................................................... A-38
3 Installation and shutdown cobas b 121 system
Table of contents
2. Remove the V2 and V9 tube ends from the guides .................................. A-39
3. Insert the shutdown kit and connect it .................................................... A-39
4. Remove the shutdown kit .......................................................................... A-40
5. Remove the waste container ...................................................................... A-40
6. Return the V2 and V9 tube ends to the guides ........................................ A-40
7. Remove the pump tube ............................................................................. A-41
8. Remove the electrodes ............................................................................... A-41
9. Remove needle and fill port ...................................................................... A-42
10. Remove the printer paper ....................................................................... A-42
11. Remove the tube under V1 and V2 ........................................................ A-42
12. Shutting down the AutoQC module ...................................................... A-43
13. Uninstall the AutoQC module ................................................................ A-43

Installation
Installation
Location
NOTE:
Never set up the cobas b 121 system in the immediate vicinity of patients. Maintain a
safety distance of 1.5 meters (5 feet).
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 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 For proper air circulation and the electrical connections, the following clearances
should be observed around the instrument:
O 8 cm on each side
O 15 cm behind the instrument
O 13 cm above the instrument
o Check for the correct voltage: 100 to 240 VAC (±10%)
After the cobas b 121 system has been set up at a location that meets the mandatory
requirements, carry out the following steps to prepare the instrument for operation:
o First, check the instrument and accessories for completeness and potential
damage. Verify that the shipment is complete by comparing components with the
shipping order.
Should anything be missing, please notify a Roche representative immediately.
If the shipment has been damaged despite careful packaging, notify the forwarder
immediately. Keep the delivered goods and packaging material until your damage
claim is resolved.
Do not under any circumstances insert consumables into the instrument if the packaging
of these consumables suffered massive damage!
ATTENTION Using damaged consumables can cause malfunctions of the instrument.

Installation
Accessories
The following parts are delivered as standard equipment with the instrument:
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 (Figure A-8/1).
2 Connect the barcode scanner and. if necessary, the network cable (Figure A-8/2)
to the respective interface(s) (Figure A-8/2) on the reverse side of the instrument.
(1) Power supply (2) Interfaces
Figure A-8
3 Open the bottle compartment cover and the docking mechanism.
A Docking mechanism
Figure A-9

Installation
a If available (optional equipment), install the AutoQC module.
2. Installing the AutoQC module (Automatic Quality Control Module)
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 compart-
ATTENTION ment (see Figure A-10)!
Not prepared Prepared
Figure 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 the transport safety band and both safety
screws (see Figure 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 A-11/2).
(1) (2)
A Transport safety band B Red plastic relief clamp
Figure A-11

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 instrument 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 AutoQC docking port
Figure A-12
4 Connect both tube ends in the bottle compartment to the docking part according
to Figure A-13.
Figure A-13
5 Connect the cable of the AutoQC module to the jack on the reverse side of the
instrument.

Installation
Figure A-14
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 baro-
meter 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 Select the language and confirm your selection.

e For a detailed description, see Reference Manual chapter Setup!
5. Setting the date and time
Press:
h [Setup] > [Times & intervals] > [Date/Time]
6. Check/Activate the parameters tHb and SO2
Press:
h [Setup] > [Parameters] > [Misc. settings] > [Act. / deact. f. measurement]

Installation
7. Checking the barometer value
Press:
h [More functions] > [System] > [Test] > [Control Sensors] > [Barosensor]
If the barometer value deviates by more than +/- 2 mmHg from the value indicated by
a precision barometer, it will be necessary for technical support to calibrate 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] > [System] > [Tools] > [Installation]
o Follow the instructions on the screen!
Confirm every step by pressing the [Confirm] button.
10. Check tubes at V2 and V9

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

Installation
11. Insert FMS tubes (Fluid Mixing System)

1 Slide the feed tube of the C1 solution under the tube clip (valve V1).
2 Slide the feed tube of the C2 solution under the tube clip (valve V2)
(see Figure A-16).
3 Both of these valves are located on the back wall of the bottle compartment.
A Tube of the C1 solution B Tube of the C2 solution
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 AutoQC module.
4 Perform the mat assignments and program the AutoQC times.
e See Chapter 6 Quality control!
13. Attach pump tube

1 Open the instrument cover.
2 Open the peristaltic pump's clear plastic cover (tension lever). Push the linear
bracket (white plastic part) upwards (Figure A-17).
3 Place the tube around the rolling wheel.
4 Close the clear plastic cover (tension lever). The tubing holder is then pressed into
the sealer.

Installation
Pump closed
A Tension lever C Linear clamp
B Pump head
Figure A-17
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.
Figure A-18
3 Rotate the fill port holder so that the underside shows on the top (see
Figure A-19/1) and then push this over the needle (see Figure A-19/2).
Do not bend the needle when pushing it up!
4 Snap the fill port holder evenly onto the axis (see Figure A-19/3).

Installation
(1) (2) (3)
Figure A-19
5 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.
1 Open the printer cover.

2 Place the new paper roll into the holder.
3 Make sure that the printer lever is in the "down" position (see Figure A-20).
A Printer lever
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. The paper is automatically pulled into the printer.

Installation
6 Close the printer cover and feed the paper outward through the slit in the printer
cover.
A Slit in the printer cover.
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 tool on the screw cap of the C1 or C2 (Figure A-22/1).
2 Press the grips together and press the transparent disk downward Figure A-22/2).
3 Rotate the transparent disk in the clockwise direction. Stop when you notice (after
a short distance) resistance (Figure A-22/3).
(1) (2) (3)
Figure A-22
4 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 A-23).

Installation
Figure A-23
5 The instrument recognizes the correct solution and checks the expiration date.
On the screen, the respective bottle starts blinking. If the bottle has passed the
expiration date, the screen displays a warning.
6 Confirm with this button.
Remove rubber sealings from C3 Fluid Pack before inserting it!
7 Insert the bottle completely into the appropriate position, following the
instructions on the docking mechanism (see Figure A-24/2). The bottles are
opened automatically.
8 Close the docking mechanism.
Check the positions of the bottles by matching the labels on the docking
mechanisms to the labels on the bottles (see Figure A-24/3).
(1) (2)
Figure A-24
9 Close the bottle compartment cover.

Installation
17. Insert electrodes

1 Open the measuring chamber cover.
2 Open locking lever.
3 Follow the instructions on the screen.
Figure A-25
Make sure that no air bubbles have formed in the inner electrolytes of the electrodes (see
Figure A-26). If there are air bubbles between the contact pin and the membrane, there
will not be effective electrical conduction. Result: calibration and measurement errors!
4 If necessary, remove air bubbles by holding the electrode vertically and by tapping
lightly with your fingernail against the electrode body (see Figure A-26).
A Fee of air bubbles
Figure A-26
5 Insert the electrodes, beginning at the right 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.

Installation
18. Insertion of the reference electrode

1 Insert the reference electrode.
Figure A-27
2 Place the tube into the tube guide slot (seeFigure 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) (2)
A Locking lever
B Reference electrode
Figure A-28
3 Affix the white plug at the end of the reference electrode tube (see Figure A-29).
Push the plug in completely.

Installation
A A
A White plug at the end of the reference

electrode
Figure A-29
4 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.
Figure A-30
6 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!
Figure A-31
7 The corresponding electrode starts blinking on the screen.

Confirm with this button.

Installation
8 Close the measuring chamber and then the instrument cover.
19. Begin installation routines
1 Press [Start].
2 All solutions are aspirated and the system is calibrated; this may take longer than
the respective actions during operation.
3 Installation is complete.
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 quality control measurement.
e For instructions, see Chapter 6 Quality control!
2 Perform a quality control on all 3 levels (1 = low, 2 = normal, 3 = high).

Make sure that the results agree with the target values.

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

Switch off the instrument.
Longer than 24 hours
If the instrument will be shut down for longer than 24 hours, perform the following
procedure.
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-62
Roche recommends decontaminating all surfaces and tubing before shutting down the
instrument.
e See Chapter 9 Maintenance, section Decontamination on page C-5 for a detailed

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

Follow the instructions on the screen.
Confirm every step by pressing this button!
1. Remove bottles
Open the bottle compartment cover and remove bottles C1, C2 and C3.

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

1 Remove the air mixture valve tube (valve V2) from the guide.
2 Remove the ventilation tube (valve V9) from the guide.
A Ventilation tube V9 B air mixture valve tube V2
Figure A-32
3 Place both ends of the tube onto an absorbent pad, such as a paper towel or gauze
(see Figure A-33).
A A
A End of the tubes
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.

Shutdown
Figure A-34
4 Begin the tube washing procedure by pressing the [Start ] button.
4. Remove the shutdown kit

1 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 by pressing the [Start] button.
5. Remove the waste container

Remove the waste container (W waste container).
6. Return the V2 and V9 tube ends to the guides

1 Return the air mixture valve tube (valve V2) to the guides.
2 Return the ventilation tube (valve V9) to the guides (see Figure A-35).
A Ventilation tube B Air mixture valve tube
Figure A-35
3 Close the docking mechanisms.

Shutdown
7. Remove the pump tube

1 Open the instrument cover.
2 Open the peristaltic pump's clear plastic cover (tension lever). Push the linear
clamp (white plastic piece) upwards (see Figure A-36).
3 You can now remove the entire tube set (tube holder with tubes)
(see Figure A-36).
A Tension lever
B Pump head
C Linear clamp
Figure A-36
4 Close the tension lever (clear plastic cover).
8. Remove the electrodes

1 Open the measuring chamber cover.
2 Open the locking lever.
A Locking lever B
Figure A-37
3 Remove the electrodes.

4 Close the locking lever and the measurement chamber cover.

Shutdown
9. Remove needle and fill port

2 Rotate the fill port holder in the direction of the arrow (see the marking on the fill
port holder). It will come out of the axis and snap out of place (seeFigure A-38/1).
Do not bend the needle!

ATTENTION
3 Carefully remove the fill port holder from the needle (see Figure A-38/2).
4 Remove the needle.
5 Push the needle to the left and into the sealer. Then carefully pull it upward
(see Figure A-38/3).
(1) (2) (3)
Figure A-38
6 Close the flap.
10. Remove the printer paper

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

Shutdown
A Feed tube C1 solution B feed tube: C2 solution
Figure A-39
3 Pressure is removed from the tubes.
If available (option):
12. Shutting down the AutoQC module

1 Open the cover and remove the AutoQC ampoule block.
2 The carriage in the AutoQC module moves to the service position.
3 Close all covers.
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.
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 A-40).
A Unlocking knob
Figure A-40
2 Remove both tube ends in the bottle compartment from the docking port.

Shutdown
A
A
A Tube ends B
Figure A-41
3 Unlock the AutoQC module by pulling the unlocking knob (see Figure A-40) on
the reverse side of the instrument and remove the AutoQC module from the
tracks on the instrument.
4 Insert the red plastic relief clamp for the AutoQC valve V17.
A Relief clamp for the AutoQC valve V17
Figure A-42
5 If you plan to transport the instrument, be sure to unplug the power cord, the
scanner, and the network cable. Then install the transport safety device for the
AutoQC module.
A Transport safety band
Figure A-43
6 Use the original packaging when transporting the instrument!

cobas b 121 system 4 Specifications
Table of contents
Specifications
In this chapter, the performance data, as well as product and environmental data are
described.

Performance data ...................................................................................................... A-47
Measured parameters .......................................................................................... A-47
Default and input values ........................................................................................... A-49
Sample throughput ................................................................................................... A-49
Measurement times of the samples .......................................................................... A-49
Sample volume .......................................................................................................... A-50
Sample types .............................................................................................................. A-50
Calibrations ............................................................................................................... A-50
Environmental parameters ....................................................................................... A-51
Temperature / humidity / stability ..................................................................... A-51
Product data .............................................................................................................. A-53
Electrical data ...................................................................................................... A-53
Classification (according IEC/ISO) .................................................................... A-53
Dimensions .......................................................................................................... A-53
Weight .................................................................................................................. A-53
Printer ........................................................................................................................ A-53
Screen ......................................................................................................................... A-54
Barcode scanner ........................................................................................................ A-54

4 Specifications cobas b 121 system
Table of contents

Performance data
Performance data
Measured parameters
specified Specified range Precision(a) (b) Precision (a) (b) Accuracy(a)

for (within-run) (day-day)
PO2 B 0 - < 60 mmHg SD < 4.0 mmHg SD < 6.0 mmHg < ± 8.0 mmHg
60 - 140 mmHg SD < 2.0 mmHg SD < 3.0 mmHg ± 4.0 mmHg
> 140 - 500 mmHg SD < (2% - 0.8 mmHg) SD < (4% - 2.6 mmHg) < ± (6% - 4.4 mmHg)
> 500 - 800 mmHg SD < (4% - 11.8 mmHg) SD < (8% - 22.6 mmHg) < ± (12% - 34.4 mmHg)
0 - > 7.998 kPa SD < 0.533 kPa SD > 0.800 kPa < ± 1.066 kPa
7.998 - 18.662 kPa SD < 0.267 kPa SD < 0.400 kPa ± 0.533 kPa
> 18.662 - 66.650 kPa SD < (2% - 0.107 kPa) SD < (4% - 0.347 kPa) < ± (6% - 0.587 kPa)
> 66.650 - 106.640 kPa SD < (4% - 1.573 kPa) SD < (8% - 3.013 kPa) < ± (12% - 4.586 kPa)
Q 0 - < 60 mmHg SD < (10.7 - 12%) mmHg SD < (12.2 - 12%) mmHg < ± (16.8 - 13%) mmHg
> 200 - 800 mmHg SD < (7% - 10.5) mmHg SD < (7% - 9.0) mmHg < ± (6..5% - 4) mmHg
0 -< 7.998 kPa SD < (1.426 - 12%) kPa SD < (1.626 - 12%) kPa < ± (2.239 - 13%) kPa
26.660 - 106.640 kPa SD < (7% - 1.400) kPa SD < (7% - 1.200) kPa < ± (6.5% - 0.533) kPa
PCO2 B/Q 4 - < 15 mmHg SD < 2 mmHg SD < 3 mmHg ± 4 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
pH B/Q 6.0 - < 6.8 SD < 0.020 SD < 0.035 ± 0.06
6.8 - 7.6 SD < 0.008 SD < 0.015 ± 0.02
> 7.6 - 8.0 SD < 0.015 SD < 0.030 ± 0.04
+
Na B/S/A/D/Q 20 - < 120 mmol/L SD < 4.5 mmol/L SD < 6 mmol/L ± 8 mmol/L
120 - 170 mmol/L SD < 1.5 mmol/L SD < 2.0 mmol/L ± 2.5 mmol/L
> 170 - 250 mmol/L SD < 6 mmol/L SD < 8 mmol/L ± 10 mmol/L
K+ B/S/A/D/Q 0.2 - < 3.0 mmol/L SD < 0.15 mmol/L SD < 0.35 mmol/L ± 0.5 mmol/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
Cl- B/S/A/D/Q 20 - < 70 mmol/L SD < 3 mmol/L SD < 4 mmol/L ± 8.0 mmol/L
70 - 130 mmol/L SD < 1.5 mmol/L SD < 2.0 mmol/L ± 4.0 mmol/L
> 130 - 250 mmol/L SD < 4.5 mmol/L SD < 6 mmol/L ± 12.0 mmol/L
Table A-1

Performance data
specified Specified range Precision(a) (b) Precision (a) (b) Accuracy(a)

for (within-run) (day-day)
Ca2+ B/S/A/D/Q 0.1 - < 0.6 mmol/L SD < 0.06 mmol/L SD < 0.1 mmol/L ± 0.2 mmol/L
0.6 - 1.5 mmol/L SD < 0.03 mmol/L SD < 0.05 mmol/L ± 0.1 mmol/L
> 1.5 - 4.0 mmol/L SD < 0.15 mmol/L SD < 0.25 mmol/L ± 0.5 mmol/L
0.4008 - < 2.4048 mg/dL SD < 0.2405 mg/dL SD < 0.4008 mg/dL ± 0.8016 mg/dL
2.4048 - 6.0120 mg/dL SD < 0.1202 mg/dL SD < 0.2004 mg/dL ± 0.4008 mg/dL
> 6.0120 - 16.0320 mg/dL SD < 0.6012 mg/dL SD < 1.0020 mg/dL ± 2.0040 mg/dL
Hct B/Q 10 - < 20% SD < 3% SD < 5% ± 6.0%
20 - 60% SD < 1.5% SD < 2.5% ± 3.0%
< 60 - 80% SD < 3% SD < 5 % ± 6.0%
0.100 - < 0.200 SD < 0.030 SD < 0.050 ± 0.060
0.200 - 0.600 SD < 0.015 SD < 0.025 ± 0.030
< 0.600 - 0.800 SD < 0.030 SD < 0.050 ± 0.060
tHb B 3 - < 6 g/dL SD< (3.0% + 0.27 g/dL) SD < (3.3% + 0.30 g/dL) < ± (-3.3% + 0.70 g/dL)
6 - 18 g/dL SD < 0.45 g/dL SD < 0.5 g/dL < ± 0.5 g/dL
> 18 - 25 g/dL SD < (2.1% + 0.06 g/dL) SD < (2.1% + 0.11 g/dL) <± (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/L SD < (2.1% + 0.60 g/L) SD < (2.1% + 1.10 g/L) <± (7.1% - 7.80 g/L)
1.86 - < 3.72 mmol/L SD < (3.0% + 0.17 mmol/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 SD < 0.31 mmol/L < ± 0.31 mmol/L
> 11.16-15.51 mmol/L SD < (2.1% + 0.04 mmol/L) SD < (2.1%+0.07 mmol/L) <± (7.1%-0.48 mmol/L)
Q 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%
SO2 B 50 - < 60% SD < (-5.0% + 4.0 %) ---------------------------- < ± (-20% + 14%)
60 - 100% SD < 1.0% ---------------------------- < ± 2.0%
Q 50 - 100% SD < 1.0% SD < 1.1% < ± 2.0%
(c)
Baro 300 - 800 mmHg ---------------------------- ---------------------------- < 5.0 mmHg
39.990 - 106.640 kPa ---------------------------- ---------------------------- 0.667 kPa
Table A-1
(a) Accuracy and standard deviations: specified for the standard temperature range of 15 - 31 °C!
(b) According to CLSI within the specific range
(c) When used within the range of 300...450 mmHg, the barosensor must be calibrated by technical support before initial start up!
B....whole blood A....dialysis solutions containing acetate S...serum or plasma

Q....aqueous QC material D...dialysis solutions containing bicarbonate

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

tHb 15.0 g/dL 11,0 - 16.0 g/dL 1.0 - 26.0 g/dL
150.0 g/L 110.0 - 160.0 g/L 10.0 - 260.0 g/L
9.3 mmol/L 6.8 - 9.9 mmol/L 6.2 - 161.3 mmol/L
P50 Adult 26.7 mmHg not editable not editable
3.56 kPa
P50 Fetal 21.5 mmHg not editable not editable
2.87 kPa
FIO2 0.21 0.1 - 1.0 0.1 - 1.0
R 0.84 0.7 - 2.0 0.7 - 2.0
Patient temperature 37.0 °C 2.0 - 44.0 °C 2.0 - 44.0 °C
98.6 °F 35.6 - 111.0 °F 35.6 - 111.0 °F
Table A-2
Sample throughput
Activated / installed Typical sample throughput

electrodes [samples / hours]
Syringe Capillary
BG - tHb/SO2 30 30
BG - ISE - tHb/SO2 30 30
Table A-3
Measurement times of the samples
Measurement times [seconds]

Total time Until display
cobas b 121 system 120 50
Table A-4

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

required!
Activated / installed electrodes Typical sample volume Typical specimen volume Typical specimen volume
[µL](a) (capillary position) (syringe position)
[µL](b) [µL](c)
BG - ISE - tHb/SO2 60 68 90
(a) typical for Hct ≤ 45%
(b) Volume limitation through sample sensor: If the specified volume is reached, an aspiration stop occurs (approx. 1 second). If the capillary is not
removed, the aspiration process continues.
(c) No aspiration stop in the syringe position.
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 < 15
(alternatively 8, 12 or 24 hours)
1P cal every 30 minute (alternatively 1 hour) <2
2P cal every 12 hours <7
(alternatively 4, 8, 12 hours)
Warm-up phase when turning (a) < 25
Warm-up phase power fail < 1 minute <2
Electrode exchange as needed < 27
Table A-5
(a) incl. calibration

Environmental parameters
Temperature / humidity / stability
Instrument
Operating conditions
o Ambient temperature +15 °C to +33 °C
o Ambient air pressure 462 - 800 mmHg (61.63 - 106.60 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 < +33 °C
o Measurement chamber temp. 37°C ± 0.2 °C
(a) TIP: An atmospheric pressure of 462 mmHg (61.63 kPa) corresponds to 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
o Ambient temperature +15 °C to +33 °C
o Measurement chamber temp. +37 °C ± 0,2 °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 conditions in original packaging

o Temperatur +2 °C to +30 °C
o Humidity 20 to 80 % (not condensed)
over a period of 3 days

Solutions
o Ambient temperature +15°C to +33 °C
20 - 90%, if T > +31 °C to < +33 °C

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 from delivery from the factory!
Transportation conditions in original packaging

o Temperatur +2 °C to +45 °C over a period of 7 days
o Relative humidity 20 - 95%
Stability during operation

Solutions Description With ambient temperature
of +15 °C to +33 °C [weeks]
o C1 Calibration Solution 1 Calibration min. 4 up to 6 (depending on the
Solution remaining volume)
o C2 Calibration Solution 2 Calibration min. 4 up to 6 (depending on the
Solution remaining volume)
o C3 Fluid Pack Solution pack 8
QC material

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
or
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
Stability during operation

o COMBITROL TS+ Up to 3 months at room temperature up to 28 °C
o AUTO-TROL TS+ Up to 3 months at room temperature up to 28 °C
(incl. max. 1 month in the AutoQC module)

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
Overvoltage category: II
Contamination level: 2
Dimensions
Instrument Width: 35.4 cm

Heigth: 46.7 cm
Depth: 41.0 cm
AutoQC-Modul Width: 19.5 cm

Heigth closed: 19.8 cm (open: 38.7 cm)
Depth: 39.5 cm
Weight
cobas b 121 system (instrument): about 17 kg (without calibration solutions)

cobas b 121 system ready for shipment: about 23 kg
AutoQC module: 5.9 kg (without ampoule mats)
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

Screen
Screen
Type: integrated flat LCD screen

Format: 5.7 inch
Resolution: 320 x 240 pixel
Barcode scanner
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
(a) Further available barcode types can be programmed in accordance with the enclosed manual of the
PS2 hand-held scanner (included in scope of delivery).

Operation B
5 Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
6 Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-23
7 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-43
8 Operating modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-49
September 2011
cobas b 121 system 5 Measurement
Table of contents
Measurement
In this chapter, all information necessary for carrying out measurements is described.

Preanalytics .................................................................................................................. B-5
Sample collection .................................................................................................. B-5
Sample acquisition .......................................................................................... B-5
Acceptable anticoagulants ............................................................................... B-5
Sample collection especially for tHb, SO2 and Hct measurement ................ B-5
Sample collection containers ................................................................................ B-6
Syringes ............................................................................................................ B-6
Capillary tubes ................................................................................................. B-6
Roche MICROSAMPLER PROTECT ............................................................ B-7
Sample collection container accessories ......................................................... B-7
Sample handling .................................................................................................... B-8
Whole blood .................................................................................................... B-8
Serum ............................................................................................................... B-8
Plasma .............................................................................................................. B-8
Interferences ................................................................................................................ B-9
Effect of the substances on pH, BG ...................................................................... B-9
Effect of the substances on ISE ........................................................................... B-12
Effect of the substances on tHb/SO2 .................................................................. B-16
Measuring procedure ................................................................................................ B-17
Syringe mode ....................................................................................................... B-18
Capillary mode .................................................................................................... B-19
Data input ............................................................................................................ B-21
Results display / measurement report ................................................................ B-22

Instructions for Use · Version 12.0 B-3
5 Measurement cobas b 121 system
Table of contents

B-4 Instructions for Use · Version 12.0
Preanalytics
Preanalytics
Sample collection
Follow the usual applicable safety precautions when drawing blood samples. When
handling blood samples, there always exists the danger of transmission of HIV, hepatitis B
and C viruses or other pathogens transmissible by blood. Employ suitable blood sampling
techniques in order to reduce risk to personnel.
goggles and if necessary mouth protectors, must be worn to prevent direct contact with
biological working materials. In addition, a face mask is required if there is a risk.
e Please refer to CLSI document M29-A3, "Protection of Laboratory Workers from

occupationally acquired infections." Approved guidelines - Third Edition 2005.
Sample acquisition
Only qualified personnel may perform the collection of blood needed for analytical
purposes.
The puncture site may never be squeezed! Mixing the blood sample with tissue fluid may
lead to the premature onset of clotting despite sufficient heparinization of the sample
collection containers! Incorrect sample collection or the use of an unsuitable sample
collection container may lead to errors and discrepancies in the measurement values.
e For detailed information about blood sampling, storage and handling, see for example
CLSI document H11-A4, "Procedures for the collection of arterial blood specimes;
Approved Standard (Fourth Edition 2004)".
Acceptable anticoagulants
The only clot inhibitors that may be used for analyses in the cobas b 121 system 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, SO2 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".

Preanalytics
Sample collection containers
When possible, use the sample collection systems recommended by Roche.
A BS2 Blood Sampler C Roche MICROSAMPLER PROTECT

B Capillary tubes
Figure B-1 Sample collection systems recommended by Roche
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 blood 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 PO2 values are expected to be outside the normal
range. If very high PO2 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 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.

Preanalytics
Roche MICROSAMPLER PROTECT(a)

To make arterial sample collection technically easier, the
Roche MICROSAMPLER PROTECT was developed.
The Roche MICROSAMPLER PROTECT consists of one curved plastic capillary tube
(~220 µL) in a plastic container and is ideally suited to atraumatic arterial blood col-
lection.
Each laboratory should document the permissibility of sample containers that are
used. These products vary from manufacturer to manufacturer and sometimes from
lot to lot.
The use of sample containers or clot inhibitors other than those manufactured by Roche
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.
Sample collection container accessories

The use of a clot catcher is recommended to prevent clogging of the sample path
during measurement of critical blood, for example, when sampling blood of
newborns from earlobes or heels.
Clot Catcher The Clot Catcher, which is placed on top of the capillary or
Roche MICROSAMPLER PROTECT, prevents blood clots and tissue particles from
entering the cobas b 121 system.
Using the Clot Catcher is suitable for the capillary mode of the cobas b 121 system
only.
The Clot Catcher cannot be used in "Syringe mode" and not be connected in
"Capillary mode".
WARNING The capillary with attached Clot Catcher must be held in position!
Clot Catcher PRO The Clot Catcher PRO, which is placed on top of a syringe, prevents blood clots and
tissue particles from entering the cobas b 121 system.
Using the Clot Catcher PRO is suitable for the capillary mode of the
cobas b 121 system only.
The Clot Catcher PRO is not suitable for syringe mode of the cobas b 121 system.
WARNING
For additional information, refer to the accompanying package insert:

o Clot Catcher
o Clot Catcher PRO.
(a) is a trademark of Roche

Preanalytics
Sample handling
Whole blood
Withdraw whole blood samples using heparinized syringes, capillaries, or the
Roche MICROSAMPLER PROTECT. Analyze the samples as soon as possible after
sampling. Remove air bubbles from the sample collection container immediately after
the sampling procedure.
Immediately after withdrawing the sample with syringes, 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 documentation proce-
dure.
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. Complete the measurement within 30 minutes (but not after more than 60
minutes).
o Samples with a PO2 level above 200 mmHg (26 kPa) should be collected in a glass
container if the measurement can not be performed within 15 minutes.
When using capillaries analyze samples for tHb, SO2 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 in a centrifuge to
separate the cellular, solid components and the fibrin from the 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.

Interferences
Interferences
The measuring module and measuring sensors were tested with respect to their inter-
ference stability with the given chemical substances and pharmaceuticals. Respective
concentrations of the interference substances were added to the serum samples, as
suggested by the CLSI, and then measured again.
(I) Control serum + interference substance

(K) Control serum
MV Mean value
SD Standard deviation
Effect of the substances on pH, BG
Substance Concentration of Parameter MW (I)-(K) ± SD MW (I) MW (K)

the substance (n=40)
Acetaminophen (Paracetamol) 200 mg/L pH 0.135 ± 0.003 7.591 7.456
PCO2 -12.6 ± 0.2 26.6 39.2
PO2 -14.0 ± 0.4 173.5 187.5
Acetaminophen (Paracetamol) 20 mg/L pH 0.130 ± 0.001 7.602 7.472
PCO2 -11.6 ± 0.2 25.9 37.5
PO2 -12.2 ± 0.4 172.9 185.1
Acetylcystein 150 mg/L pH 0.062 ± 0.002 7.566 7.504
PCO2 -6.6 ± 0.3 27.4 34.1
PO2 -40.6 ± 1.6 139.2 180.0
Acetylcystein 30 mg/L pH 0.077 ± 0.002 7.606 7.529
PCO2 -6.9 ± 0.1 24.8 31.7
PO2 -19.0 ± 0.9 154.6 173.9
Acetylsalycilic acid 1000 mg/L pH -0.239 ± 0.002 7.300 7.538
PCO2 16.8 ± 0.7 47.4 31.0
PO2 -8.1 ± 0.2 170.5 178.6
Acetylsalycilic acid 300 mg/L pH -0.026 ± 0.000 7.517 7.543
PCO2 -0.5 ± 0.1 30.0 30.6
PO2 -3.3 ± 0.1 168.7 172.0
Ampicillin-Na 150 mg/L pH 0.141 ± 0.005 7.636 7.496
PCO2 -11.2 ± 0.2 23.4 34.6
PO2 -10.8 ± 0.7 173.4 184.5
Ampicillin-Na 30 mg/L pH 0.128 ± 0.001 7.639 7.511
PCO2 -10.1 ± 0.2 22.9 33.0
PO2 -6.6 ± 0.3 173.0 179.5
Ascorbic acid 300 mg/L pH -0.005 ± 0.002 7.558 7.563
PCO2 -1.5 ± 0.2 27.5 29.0
PO2 -10.6 ± 0.7 159.3 170.0
Table B-1 Effect of the substances on pH, BG

Interferences

Ascorbic acid 30 mg/L pH 0.061 ± 0.002 7.652 7.591
PCO2 -4.7 ± 0.1 22.1 26.8
PO2 -1.1 ± 0.4 167.0 167.9
Cefoxitin 2500 mg/L pH 0.123 ± 0.003 7.644 7.521
PCO2 -9.4 ± 0.2 22.8 32.2
PO2 -7.0 ± 0.2 166.1 173.1
Cefoxitin 250 mg/L pH 0.127 ± 0.002 7.668 7.541
PCO2 -9.4 ± 0.2 20.9 30.4
PO2 -3.6 ± 0.2 167.7 171.4
Ciclosporine 5 mg/L pH 0.022 ± 0.003 7.704 7.682
PCO2 -1.2 ± 0.1 19.3 20.5
PO2 -0.7 ± 0.2 169.9 170.6
Ciclosporine 1 mg/L pH 0.026 ± 0.002 7.828 7.802
PCO2 -1.0 ± 0.1 13.2 14.2
PO2 -1.5 ± 0.2 163.8 165.3
Doxycyclin 50 mg/L pH 0.093 ± 0.002 7.620 7.527
PCO2 -8.2 ± 0.1 24.1 32.3
PO2 -5.6 ± 0.1 172.3 177.9
Doxycycline 11mg/L pH 0.098 ± 0.002 7.638 7.540
PCO2 -7.9 ± 0.1 23.2 31.1
PO2 -3.1 ± 0.2 171.1 174.2
Heparin 5000 IU/L pH 0.035 ± 0.006 7.703 7.667
PCO2 -2.1 ± 0.2 19.1 21.2
PO2 -14.6 ± 1.4 173.1 188.4
Heparin 10 IU/L pH 0.053 ± 0.002 7.734 7.681
PCO2 -2.9 ± 0.1 17.2 20.1
PO2 -15.1± 0.2 167.3 182.5
Ibuprofen 500 mg/L pH -0.032 ± 0.002 7.601 7.634
PCO2 0.4 ± 0.1 24.0 23.6
PO2 -16.8± 0.5 169.9 186.8
Ibuprofen 50 mg/L pH 0.075 ± 0.004 7.725 7.651
PCO2 -4.6 ± 0.3 17.7 22.3
PO2 -14.6 ± 0.4 170.2 184.9
Intralipid 10 g/L pH 0.108 ± 0.005 7.706 7.595
PCO2 -6.6 ± 0.2 17.5 24.1
PO2 -12.7 ± 0.6 170.3 182.9
Intralipid 2 g/L pH 0.098 ± 0.002 7.702 7.603
PCO2 -6.0 ± 0.3 17.7 23.7
PO2 -9.8 ± 0.6 172.8 182.7
Dobesilate 200 mg/L pH 0.103 ± 0.005 7.602 7.497
PCO2 -8.5 ± 0.3 25.5 34.1
PO2 2.8 ± 0.4 169.7 166.8

Interferences

Dobesilate 20 mg/L pH 0.131 ± 0.002 7.628 7.497
PCO2 -10.8 ± 0.3 23.3 34.1
PO2 4.5 ± 0.2 166.8 162.5
Levodopa 20 mg/L pH 0.011 ± 0.002 7.586 7.576
PCO2 -1.1 ± 0.1 26.8 27.9
PO2 -4.3 ± 0.7 170.0 174.7
Levodopa 4 mg/L pH 0.099 ± 0.003 7.697 7.598
PCO2 -6.5 ± 0.3 19.6 26.1
PO2 -5.3± 0.3 168.1 173.3
Methyldopa 20 mg/L pH 0.025 ± 0.006 7.599 7.574
PCO2 -1.9 ± 0.3 25.3 27.1
PO2 -0.4 ± 0.3 170.4 170.9
Methyldopa 2 mg/L pH 0.107 ± 0.003 7.709 7.601
PCO2 -6.8 ± 0.3 18.3 25.1
PO2 -0.2 ± 0.3 168.4 168.6
Metronidazole 200 mg/L pH 0.033 ± 0.003 7.729 7.696
PCO2 -1.6 ± 0.2 16.0 17.6
PO2 -15.4 ± 1.1 174.9 190.4
Metronidazole 10 mg/L pH 0.036 ± 0.002 7.735 7.699
PCO2 -1.8 ± 0.1 15.5 17.2
PO2 -11.5 ± 0.4 176.0 187.4
Phenylbutazone 400 mg/L pH -0.012 ± 0.002 7.530 7.542
PCO2 -0.5 ± 0.3 30.6 31.0
PO2 -14.6 ± 0.6 167.8 182.8
Phenylbutazone 100 mg/L pH 0.101 ± 0.003 7.719 7.618
PCO2 -6.5 ± 0.1 18.1 24.7
PO2 -8.3 ± 0.3 169.9 178.3
Rifampicin 60 mg/L pH 0.125 ± 0.003 7.612 7.487
PCO2 -10.6 ± 0.2 24.9 35.5
PO2 -10.3 ± 0.4 173.4 183.7
Rifampicin 20 mg/L pH 0.127 ± 0.002 7.625 7.498
PCO2 -10.6 ± 0.3 23.9 34.5
PO2 -11.0 ± 0.7 171.5 182.5
Theophyline 100 mg/L pH 0.112 ± 0.001 7.624 7.512
PCO2 -9.3 ± 0.1 24.1 33.4
PO2 -15.2 ± 0.3 172.8 188.0
Theophyline 10 mg/L pH 0.116 ± 0.001 7.641 7.524
PCO2 -9.3 ± 0.1 22.9 32.2
PO2 -13.7 ± 0.5 171.4 185.0

Interferences
Effect of the substances on ISE

Acetaminophen (Paracetamol) 200 mg/L Na+ -0.2 ± 0.1 139.2 139.5
+
K -0.01 ± 0.0 3.81 3.82
Cl- 0.3 ± 0.2 101.8 101.5
Ca2+ -0.07 ± 0.0 1.10 1.17
Acetaminophen (Paracetamol) 20 mg/L Na+ -0.2 ± 0.1 139.3 139.5
+
K 0.00 ± 0.0 3.82 3.82
Cl- 0.2 ± 0.0 101.9 101.7
Ca2+ -0.06 ± 0.0 1.09 1.15
Acetylcystein 150 mg/L Na+ -0.2 ± 0.1 138.8 139.0
+
K 0.00 ± 0.0 3.82 3.82
Cl- 0.2 ± 0.1 101.9 101.8
Ca2+ -0.03 ± 0.0 1.12 1.15
Acetylcystein 30 mg/L Na+ -0.2 ± 0.0 139.0 139.2
+
K -0.01 ± 0.0 3.82 3.83
Cl- 0.2 ± 0.1 102.2 102.0
Ca2+ -0.04 ± 0.0 1.09 1.13
Acetylsalycilic acid 1000 mg/L Na+ 0.5 ± 0.1 139.8 139.3
+
K 0.01 ± 0.01 3.81 3.81
Cl- 4.1 ± 0.5 106.4 102.3
Ca2+ 0.15 ± 0.01 1.31 1.16
Acetylsalycilic acid 300 mg/L Na+ 0.1 ± 0.1 139.5 139.4
+
K 0.00 ± 0.0 3.82 3.82
Cl- 1.4 ± 0.1 103.6 102.3
Ca2+ 0.02 ± 0.0 1.18 1.16
Ampicillin-Na 150 mg/L Na+ 1.8 ± 0.2 141.0 139.2
+
K -0.02 ± 0.01 3.88 3.89
Cl- 1.8 ± 0.2 103.5 101.7
Ca2+ -0.07 ± 0.01 1.10 1.16
Ampicillin-Na 30 mg/L Na+ 0.3 ± 0.1 139.8 139.5
+
K -0.01 ± 0.01 3.91 3.92
Cl- 0.5 ± 0.1 102.3 101.8
Ca2+ -0.06 ± 0.01 1.10 1.16
+
Ascorbic acid 300 mg/L Na -0.2 ± 0.1 140.0 140.2
+
K -0.01 ± 0.01 4.01 4.02
Cl- 0.1 ± 0.2 103.0 103.0
Ca2+ 0.01 ± 0.01 1.17 1.16
+
Ascorbic acid 30 mg/L Na -0.1 ± 0.1 140.2 140.3
+
K 0.01 ± 0.01 4.03 4.02
Cl- 0.1 ± 0.2 103.1 103.0
Ca2+ -0.03 ± 0.01 1.13 1.15
Table B-2 Effect of the substances on ISE

Interferences

Cefoxitin 2500 mg/L Na+ 3.5 ± 0.2 142.8 139.4
+
K -0.01 ± 0.01 3.91 3.91
-
Cl 2.7 ± 0.5 104.8 102.0
2+
Ca -0.11 ± 0.01 1.04 1.15
Cefoxitin 250 mg/L Na+ 0.3 ± 0.1 139.7 139.4
K+ 0.01 ± 0.01 3.92 3.91
-
Cl 0.5 ± 0.1 102.5 102.0
2+
Ca -0.05 ± 0.01 1.09 1.14
Ciclosporine 5 mg/L Na+ -0.1 ± 0.1 140.5 140.6
K+ 0.01 ± 0.01 3.84 3.84
-
Cl 0.1 ± 0.1 103.0 102.9
2+
Ca -0.01 ± 0.01 1.10 1.11
Ciclosporine 1 mg/L Na+ -0.1 ± 0.1 140.5 140.6
K+ 0.01 ± 0.01 3.84 3.84
-
Cl 0.1 ± 0.1 103.5 103.4
2+
Ca -0.01 ± 0.01 1.05 1.06
Doxycycline 50 mg/L Na+ -0.2 ± 0.1 140.0 140.2
K+ 0.00 ± 0.01 4.01 4.01
-
Cl 0.2 ± 0.1 103.1 102.9
2+
Ca -0.07 ± 0.01 1.11 1.18
Doxycycline 11 mg/L Na+ -0.2 ± 0.1 140.0 140.1
K+ 0.00 ± 0.01 4.01 4.01
-
Cl 0.2 ± 0.1 103.1 102.9
2+
Ca -0.06 ± 0.01 1.12 1.18
Heparin 5000 IU/L Na+ -0.1 ± 0.2 139.1 139.2
K+ 0.02 ± 0.01 3.88 3.86
-
Cl 0.2 ± 0.1 102.8 102.7
2+
Ca -0.02 ± 0.01 1.15 1.17
Heparin 10 IU/L Na+ -0.1 ± 0.1 139.2 139.3
K+ 0.01 ± 0.01 3.87 3.87
-
Cl 0.1 ± 0.1 102.8 102.8
2+
Ca -0.02 ± 0.01 1.15 1.16
Ibuprofen 500 mg/L Na+ 0.1 ± 0.1 139.1 139.1
K+ 0.0 ± 0.1 3.81 3.81
-
Cl 1.3 ± 0.2 103.8 102.5
2+
Ca 0.04 ± 0.01 1.22 1.18
Ibuprofen 50 mg/L Na+ -0.1 ± 0.1 139.0 139.2
K+ 0.0 ± 0.1 3.82 3.82
-
Cl 0.2 ± 0.2 102.9 102.7
2+
Ca -0.02 ± 0.01 1.15 1.17

Interferences

Intralipid 10 g/L Na+ -1.2 ± 0.2 137.6 138.8
+
K -0.02 ± 0.01 3.82 3.84
-
Cl -0.6 ± 0.2 102.6 103.1
2+
Ca -0.05 ± 0.01 1.11 1.17
Intralipid 2 g/L Na+ -0.4 ± 0.1 138.8 139.1
K+ -0.01 ± 0.01 3.85 3.86
-
Cl 0.1 ± 0.1 103.4 103.4
2+
Ca -0.04 ± 0.01 1.12 1.16
Dobesilate 200 mg/L Na+ -0.6 ± 0.1 139.2 139.8
K+ 0.97 ± 0.03 5.19 4.21
-
Cl 1.1 ± 0.2 104.0 102.9
2+
Ca -0.06 ± 0.01 1.10 1.17
Dobesilate 20 mg/L Na+ -0.3 ± 0.1 139.6 140.0
K+ 0.25 ± 0.01 4.34 4.09
-
Cl 0.4 ± 0.1 103.2 102.8
2+
Ca -0.07 ± 0.01 1.10 1.17
Levodopa 20 mg/L Na+ -0.1 ± 0.1 139.1 139.1
K+ 0.01 ± 0.01 4.00 4.00
-
Cl 0.1 ± 0.1 102.9 102.9
2+
Ca -0.01 ± 0.01 1.14 1.14
Levodopa 4 mg/L Na+ -0.1 ± 0.1 139.9 139.9
K+ 0.00 ± 0.01 4.04 4.04
-
Cl 0.2 ± 0.1 103.6 103.3
2+
Ca -0.04 ± 0.01 1.08 1.13
Methyldopa 20 mg/L Na+ 0.1 ± 0.2 139.5 139.5
K+ 0.00 ± 0.01 4.08 4.08
-
Cl 0.1 ± 0.1 102.9 102.9
2+
Ca -0.04 ± 0.01 1.17 1.18
Methyldopa 2 mg/L Na+ -0.2 ± 0.1 139.3 139.6
K+ 0.00 ± 0.01 4.08 4.08
-
Cl 0.1 ± 0.1 103.0 103.0
2+
Ca -0.04 ± 0.01 1.12 1.17
Metronidazole 200 mg/L Na+ 0.1 ± 0.1 138.6 138.6
K+ 0.01 ± 0.01 3.85 3.85
-
Cl 0.2 ± 0.1 103.9 103.7
2+
Ca -0.01 ± 0.01 1.23 1.24
Metronidazole 10 mg/L Na+ -0.1 ± 0.1 138.7 138.8
K+ 0.00 ± 0.01 3.86 3.86
-
Cl 0.1 ± 0.1 103.5 103.4
2+
Ca -0.01 ± 0.01 1.23 1.24

Interferences

Phenylbutazone 400 mg/L Na+ 0.0 ± 0.1 140.5 140.6
+
K -0.01 ± 0.01 3.81 3.82
-
Cl 0.7 ± 0.1 103.4 102.6
2+
Ca 0.02 ± 0.01 1.20 1.18
Phenylbutazone 100 mg/L Na+ -0.1 ± 0.1 140.4 140.6
K+ -0.01 ± 0.01 3.83 3.84
-
Cl 0.3 ± 0.1 103.1 102.7
2+
Ca -0.03 ± 0.01 1.10 1.14
Rifampicin 60 mg/L Na+ -0.2 ± 0.1 138.9 139.1
K+ -0.01 ± 0.01 4.16 4.18
-
Cl 0.2 ± 0.1 102.1 102.0
2+
Ca -0.07 ± 0.01 1.11 1.17
Rifampicin 20 mg/L Na+ -0.2 ± 0.1 139.0 139.2
K+ -0.01 ± 0.01 4.17 4.18
-
Cl 0.2 ± 0.1 102.4 102.2
2+
Ca -0.07 ± 0.01 1.10 1.17
Theophylline 100 mg/L Na+ -0.2 ± 0.1 139.2 139.4
K+ -0.01 ± 0.01 3.81 3.82
-
Cl 0.3 ± 0.1 101.9 101.7
2+
Ca -0.05 ± 0.01 1.09 1.14
Theophylline 10 mg/L Na+ -0.2 ± 0.1 139.2 139.4
K+ 0.00 ± 0.01 3.82 3.82
-
Cl 0.3 ± 0.1 102.1 101.8
2+
Ca -0.05 ± 0.01 1.08 1.13

Interferences
Effect of the substances on tHb/SO2
Substance Concentration of Parameter MW (I)-(K) MW (I) MW (K)

the substance (n=5)
Methylene Blue(a) 5.0 mg/dL tHb [g/dL] 0.7 9.2 8.5
SO2 [%] -47.1 52.8 99.9 (b)
0.5 mg/dL tHb [g/dL] 0.2 17.7 17.5
SO2 [%] 0.0 99.9 99.9 (f)
2.0 mg/dL SO2[%] n.a. Interferenz --
Indocyanine Green 0.5 mg/dL tHb [g/dL] 2.9 11.4 8.5
SO2 [%] 0.0 99.9 99.9 (c)
0.5 mg/dL tHb [g/dL] 5.2 22.9 17.7
(a)
Evan’s Blue tHb [g/dL] n.a. Interferenz --
SO2 [%] n.a. Interferenz --
Hemolysis 10 % tHb [g/dL] -0.3 9.6 9.9
tHb [g/dL] -0.6 17.7 18.3
SO2 [%] 0.0 99.9 99.9(d)
Ringer-lactate 50 % tHb [g/dL] 0.2 8.4 8.2
SO2 [%] 0.0 99.9 99.9
Dextran 50 % tHb [g/dL] -0.1 8.1 8.2
SO2 [%] 0.0 99.9 99.9
Beta Carotine 3 mg/dL tHb [g/dL] 0.2 8.5 8.3
SO2 [%] 0.0 99.9 99.9(e)
3 mg/dL tHb [g/dL] 0.0 18.0 18.0
SO2 [%] 0.0 99.7 99.7(f)
Bilirubin 40 mg/dL tHb [g/dL] -0.2 8.3 8.5
SO2 [%] 0.0 99.9 99.9
40 mg/dL tHb [g/dL] 0.4 18.9 18.5
SO2 [%] 0.2 99.9 99.7
Table B-3 Effect of the substances on tHb/SO2
(a) For some interferent substances it was not possible to measure the required test range (according CLSI).
In all those cases the cobas b 121 system gives an error message "tHb Interferences".
(b) at tHb 8.5 g/dL
(c) at tHb 8.5 and 17.7 g/dL
(d) at tHb 9.9 and 18.3 g/dL
(e) at tHb 8.6 g/dL
(f) at tHb 17.5 g/dL

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 See Reference Manual, chapter Setup!
A Password protection active B Mandatory input C "Ready" - without another function like
password, etc.
Figure B-2
You have the option of measuring samples from syringes (without needles), ampoules
and capillaries.

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.
Figure B-3
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 PRO cannot be used in "Syringe mode".
Figure B-4

Measuring procedure
3 The sample is automatically aspirated (it is unnecessary to press any buttons).
Figure B-5
4 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
The aspiration process is started.
Open the flap slowly to avoid splattering small drops of liquid that are on the needle tip.
Figure B-6

Measuring procedure
2 Insert the capillaries or the Roche MICROSAMPLER PROTECT 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!
Figure B-7
3 The sample is aspirated automatically into the analyzer.
Figure B-8
4 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!

Measuring procedure
Data input
During measurement, various patient, operator, and sample-specific data may be

entered. You may use a standardized or a user-specific form when entering data.
Scanning of patient and operator data 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
h [Setup] > [Displays & reports] > [Measuring data] > [Input values]
e 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 More functions
Figure B-9
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

Measuring procedure
Results display / measurement report
After the measurement is complete and all parameters have been entered, the instru-
ment 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.
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 selecting
h [Setup] > [Displays & reports] > [Measuring data] > [Measurement report]
Press these buttons to select a predefined report.

>
This remains the standard until a new report is selected.
Figure B-10
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 in 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!

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.

Quality control - general ........................................................................................... B-25
General QC concept .................................................................................................. B-25
Important information concerning the analysis of QC measurement results ....... B-27
Material setup ............................................................................................................ B-28
Inserting AutoQC mats ....................................................................................... B-29
Material assignment - AutoQC materials .......................................................... B-29
[New mat] ...................................................................................................... B-30
AutoQC mat detail screen ............................................................................. B-30
Setting QC times ................................................................................................. B-31
Setting start time(s) ....................................................................................... B-31
Copying a time entry ..................................................................................... B-32
Measurement retries ...................................................................................... B-33
QC measurement ...................................................................................................... B-34
Manual QC measurement ................................................................................... B-34
AutoQC measurement ........................................................................................ B-35
Multirules .................................................................................................................. B-36
Overview of the Multirules ................................................................................. B-37
QC consequences ...................................................................................................... B-38
QC unlock .................................................................................................................. B-38
QC warning ......................................................................................................... B-38
QC error ............................................................................................................... B-38
Automatic lockout reversal ........................................................................... B-39
Manual lockout reversal ................................................................................ B-39
Exchange the electrode .................................................................................. B-39
QC troubleshooting .................................................................................................. B-39
Description of the current problem ................................................................... B-39
Classification of QC problems ............................................................................ B-40
6 Quality control cobas b 121 system
Table of contents
Group A ......................................................................................................... B-40

Group B .......................................................................................................... B-40
Troubleshooting – Group A (aspirating or positioning problem) ................... B-40
Troubleshooting – Group B (QC result exceeds the target value range) .......... B-40

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
WARNING incorrect patient measurements, which may result in incorrect clinical decisions, possibly
endangering the patient's health.
General QC concept
Roche always strives to ensure the highest quality standards for its 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 element of this claim. Aqueous blood gas/
electrolyte QC materials, such as COMBITROL TS+, AUTO-TROL TS+, etc., are
offered to ensure that the instrument provides measurements of high quality to
protect customers or their patients.
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 B-11
The automatic system calibration includes a complete 2P calibration.
Complete at least two quality control tests on different levels once daily or more often
in accordance with local regulations.
Run quality control tests ideally prior to sample 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.

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 PO2, 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 .

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-36!

e See section QC consequences on page B-38!
The evaluation depends upon which SD areas are featured in the 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 error
has been corrected
e See section QC unlock on page B-38!
o 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-65!
The analysis can be automated by activating additional multirules

e See section Multirules on page B-36!
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 patient
measurements.
To eliminate the error, replace the electrode and/or contact technical support.
WARNING

Material setup
Material setup
Take the lot number, expiration date, sample type, and target 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 B-12
Use the [line up] / [line down] button to select the material to be changed or to select
a new "QC material".
Using the barcode scanner to Use the barcode scanner to enter the material code found on the packaging insert.
enter data
The material code contains the information for the material, the proper level, lot
number, expiration date, and sample type.
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, expiration date, sample
type and target values.
Complete and save the entry by pressing this button twice.

Material setup
Inserting AutoQC mats
Insert the mats as follows in the 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 the mat twice so that the ampoules point up. Next,
insert the mats in the ampoule block with the ampoule necks pointing down (see
Figure B-13/1).
A AutoQC ampoule block B Inserted mats

(1) (2)
Figure B-13
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 B-13/2).
5 Repeat the same process for all additional mats.
6 Close the cover of the AutoQC module.
If only 3 full ampoules are left in a mat for a QC material, it is labeled as used.
Material assignment - AutoQC materials
Before beginning an AutoQC measurement, the selected AutoQC material must be

assigned.
Figure B-14

Material setup
1 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 the mat position.
The preprogrammed times must be deleted before the material is deleted.
e See section Setting QC times on page B-31!
AutoQC mat detail screen
Press the button [Details] to display the following details:
Figure B-15
This screen shows detailed information about the AutoQC material placed on this
mat.
Press the [Details] button again to change to the mat assignment screen.
Figure B-16
This screen shows the assignment of the selected mat.

Material setup
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 time(s) for
the AutoQC measurement(s) and/or the time for performing a manual QC
measurement. After reaching the set time, a note appears in the message window.
Figure B-17
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).
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.

Material setup
The following screen appears (for example):
Figure B-18
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.
Press [More functions]:

Material setup
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.
Figure B-19
The measurement repetition is automatically started in case of a faulty measurement.

QC measurement
QC measurement
e See section General QC concept on page B-25!
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 B-20

QC measurement
Aspirate 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 B-21
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.
Figure B-22
9 Remove the ampoule and close the flap.

10 The measurement starts 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 can be performed in programmed or manual mode.

To start measurement of the control material, activate the corresponding AutoQC
material (AUTO-TROL TS) and the selected level (e.g. level 1).
Start the AutoQC measurement by pressing [AutoQC].

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 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. COMBITROL TS+, 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 required.
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 B-23
Select additional desired rules in the left window and assign it to the corresponding
parameter which is listed in the right window under "Parameters".
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. Westgard, et al: A Multi-Rule Shewhart Chart for Quality Control in Clinical Chemistry.
Clinical Chemistry, Vol. 27, No.3, 1981
(b) Elsa F. Quam BS, Lorene K. Haessig BS, Marlene J. Koch BS: A Comprehensive Statistical Quality
Control Program for Blood Gas Analyzers. Journal of Medical Technology 2:1 January 1985

Multirules
Overview of the Multirules
Run time between two 2-point calibrations

NT 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
NT ≥ 6
6. 9m QC measurement values (m) are on the same side as the mean
value
NT ≥ 9
2SD range Defined target values (ranges)
Table B-4
The Multirule process is applied after each individual measurement.

Multirules are only applied to the corresponding control material (e.g. COMBITROL TS+).

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 assigned QC consequences:
h [Setup] > [Parameter] > [Miscellaneous settings] > [QC Consequences]
Figure B-24
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.
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 cause of the lockout is known and the
error is corrected (e.g., timeout or measurement of wrong ampoule).

QC troubleshooting
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 unlocked 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 analyze it as described under Important information
concerning the analysis of QC measurement results on page B-27.
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 C-20!
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 if
the same material / level combination is measured.

QC troubleshooting
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. 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 – Group A (aspirating or positioning problem)
1 Check whether all parameters are calibrated.

2 Repeat the QC measurement (with same material / level 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 See Figure B-18 on page B-32!
o Repeat the QC measurement (with same material / level combination).
o If the error persists, contact customer service.
4 For the measuring chamber, call up an "Internal cleaning of sample path"
([System] > [Wash & clean] > [Automatic routines]). Then, carry out a blood
sample measurement in order to wet the liquid paths.
o If the error persists, contact customer service.
Troubleshooting – Group B (QC result exceeds the target value range)
1 A system calibration must be carried out for the affected parameters.

2 The following points must be checked:
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 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].

QC troubleshooting
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 time
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
control] > [AutoQC temperature].
o If the error persists, call up an "Internal cleaning of sample path" ([System] >
[Wash & clean] > [Automatic routines]). Then, carry out a blood sample
measurement in order to wet the liquid paths.
o If the error persists, replace the affected electrode/sensor. If all parameters are
affected at the same time, replace the reference electrode.
5 If the problem cannot be solved successfully, the Customer Service must be
notified.
NOTE:
For optimal display of the QC results on the screen and the printout, the QC values are
rounded. However, unrounded values are used for evaluating the individual QC results.
This can cause a "nOK" evaluation of a QC result, even if the QC result shown lies within
the target range.
This procedure is necessitated by the software and does not result in an increased patient
risk!

QC troubleshooting

cobas b 121 system 7 Calibration
Table of contents
Calibration
In this chapter, all automatic and user-activated calibrations are described.

Calibration - general ................................................................................................. B-45
Calibration progress indicator ............................................................................ B-45
Automatic calibrations ........................................................................................ B-45
System calibration ......................................................................................... B-45
2P calibration (2P cal) ................................................................................... B-46
1P calibration (1P cal) ................................................................................... B-46
Recalibration .................................................................................................. B-46
User activated calibrations .................................................................................. B-46
Calibration for "Ready" ................................................................................. B-47
System calibration ......................................................................................... B-47
Conductivity calibration ............................................................................... B-47
1P calibration ................................................................................................. B-47
2P calibration incl. O2 ................................................................................... B-47
2P O2 calibration ........................................................................................... B-47
2P calibration without O2 ............................................................................. B-47

7 Calibration cobas b 121 system
Table of contents

Calibration - general
The cobas b 121 system employs a patented method that allows the simultaneous
calibration of PCO2, 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 B-25
The progress bar visible in the calibration 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.
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.
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.
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 B-26

Using the [line up] / [line down] buttons you may now select the desired calibration.
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-45!
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.
2P O2 calibration
This calibration is a 2 point calibration for the PO2 electrode.
2P calibration without O2
This calibration is a 2 point calibration of all parameters except PO2.


cobas b 121 system 8 Operating modes
Table of contents
Operating modes
In this chapter, all the individual, independent software modes

(analyzer, setup, data manager and info) are described.

Operating modes - general ....................................................................................... B-51
User interface ............................................................................................................. B-51
Parameter ............................................................................................................. B-52
Parameter – Display on the "Ready" screen ................................................. B-52
Additional ...................................................................................................... B-52
Input parameters - patient information ....................................................... B-52
Input parameters - measurement information ............................................ B-53
Notation of the measurement, input, and calculation parameters ............. B-53
Buttons ........................................................................................................... B-54
Analyzer mode ........................................................................................................... B-56
"Ready" screen ..................................................................................................... B-56
System .................................................................................................................. B-58
Quick access ......................................................................................................... B-58
QC measurement ................................................................................................ B-59
Setup .................................................................................................................... B-59
Database ............................................................................................................... B-60
Description of the buttons and their function ............................................. B-61
More functions of the database .................................................................... B-61
Data export – PCMCIA card (for example) ................................................. B-62
Patient data .................................................................................................... B-63
Measuring data .............................................................................................. B-64
Calibration data ............................................................................................. B-64
QC data .......................................................................................................... B-65
Instrument data ............................................................................................. B-65
Info ....................................................................................................................... B-66
Roche info ...................................................................................................... B-66
Version numbers ............................................................................................ B-66
Fill levels ......................................................................................................... B-66
8 Operating modes cobas b 121 system
Table of contents
Help ................................................................................................................ B-66

Sensor status .................................................................................................. B-67
Counter overview .......................................................................................... B-67
Software overview ..................................................................................................... B-68
Software overview - Setup ................................................................................... B-69

Operating modes - general
Operating modes - general
The cobas b 121 system is a 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:
Analyzer Measuring, QC, system, calibration, commonly used functions

Setup Instrument settings
Database Data about patients, measurements, calibration, QC, and the instrument
Info Roche info, version numbers, fill levels, help, sensor status
User interface
All information (results, error messages, warnings, etc.) is displayed on the screen.
The screen consists of a 5.7" colour LCD that is covered with a touch-sensitive film
("touch screen").
For example Top level of the analyzer mode - "Ready"
A I
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 B-27
e For more detailed information refer to the respective chapters in these Instructions for Use
as well as the Reference Manual.

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
Parameter permanently deactivated (under "Setup")
(a) Pressing the parameter button produces a status report

e See Chapter 10 Troubleshooting, section Electrode status on page D-14!
Additional
o Operator ID o Sample type o Blood type o Weight

o Specimen ID o Puncture site o ALLEN test o Gender
o A/F (adult/fetal) o Pat ID o Last name o Pract. Pat ID
o First name o Middle initials o Date of birth o Height
Input parameters - patient information
o Insurance code o Suffix o Title o Remark

o Maiden name o Ethnic origin o Address o Hospital service (KH service)
o Phone no. o Diagnosis o Medication o Hospital institute
o Diet o Admission date o Admission time o Dosage cat.
o Discharge date o Discharge time o Admission status o Patient language
o Location o Diagnose code o Relig. denom. o Isolation status
o Marital status

User interface
Input parameters - measurement information
o Physician o Remark o Acceptor o Flow rate

o Date drawn o Time drawn o Place drawn o MAP
o Danger code o Clinic info o Container o PEEP
o 24 hr. urine o Ventilation mode o VT o ARATE
o MV o PIP o Ti o SRATE
o Te
Notation of the measurement, input, and calculation parameters(a)
Measured parameters PO2 Oxygen partial pressure

PCO2 Carbon dioxide partial pressure
pH Negative logarithm of the hydrogen ion activity
Na+ Sodium concentration
+
K Potassium concentration
–
Cl Chloride concentration
Ca2+ Calcium concentration
Hct Hematocrit
tHb Total hemoglobin concentration
SO2 Functional oxygen saturation
Baro Air pressure
Calculated parameters H+ Hydrogen ion concentration

– Bicarbonate concentration in plasma
cHCO3
ctCO2(P) Total CO2 concentration in plasma
ctCO2(B) Total carbon dioxide concentration in blood
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
PAO2 Alveolar oxygen partial pressure
RI Respiratory index
2+
nCa Standardized ionized calcium (pH = 7.4)
SO2(c) Functional oxygen saturation calculated with P50 as default value
AaDO2 Alveolar-arterial oxygen partial pressure
a/AO2 Alveolar-arterial oxygen partial pressure ratio
AG Anion gap
(a) Details and calculation, see Reference Manual

User interface
MCHC Middle corpuscular hemoglobin concentration

Osm Osmolality
Hct(c) Hct calculated from tHb
P/F Index PaO2/FIO2 ratio
Additional calculated parameters Qs/Qt Shunt - quotient between both oxygen concentration differences
Qt Difference of oxygen concentration between alveolar and mixed venous blood
avDO2 Arterial-venous oxygen level difference
OER Oxygen extraction ratio
Calculation after the second measurement if the following conditions are fulfilled:
o Two sequential measurements with the same Patient ID
o One measurement of arterial and one of mixed venous blood
o Maximum time interval = 30 minutes
Calculated parameters at the PAO2t Alveolar oxygen partial pressure at patient's temperature
patient's temperature t
RI Respiratory index at patient's temperature
AaDO2 t Alveolar-arterial oxygen partial pressure at patient's temperature
t
a/AO2 Alveolar-arterial oxygen partial pressure ratio at patient's temperature
t pH at patient's temperature
pH
PCO2 t PCO2 at patient's temperature
t
PO2 PO2 at patient's temperature
+t Hydrogen concentration at patient's temperature
H
Input parameters P50 Oxygen partial pressure at 50% oxygen saturation (default value depending
on A/F setting, no manual input possible)
R Respiratory quotient (=gas exchange ratio)
FIO2 Proportion of inspiratory oxygen
tHb Total hemoglobin
Temperatur Patient temperature
Buttons
Buttton Description
return to the highest level of the operating mode "Analyzer"
operating mode "Analyzer"
operating mode "Database"
operating mode "Setup"

User interface
Buttton Description
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
data input
details

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
usually in the "Ready" state.
Figure B-28
If a "mandatory input" field has been modified (in the "Setup" operating mode),
measurement can begin only after entering the data associated with this input field.
Every possible input value can be defined as a "mandatory input".
Only one input value can be defined.
In the following example, the Pat ID has been defined as a mandatory entry.
Figure B-29
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).

Analyzer mode
Figure B-30
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:
A The window is automatically closed when B More functions

this button is pressed or after a time-out.
Figure B-31

Analyzer mode
System
The following main menus are available:
Figure B-32
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 actions or change the following
settings:
Figure B-33
Start the selected function.

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 B-34
Back to the top level of the analyzer mode (= "Ready" screen)
You can activate the desired setting directly by pressing the respective line on the screen.
e For an exact description of this operating mode refer to the Reference Manual, Chapter
Setup!

Analyzer mode
Database
Use this function to retrieve the following data:
Figure B-35
Select the respective database.
You can activate the desired 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.

Analyzer mode
Description of the buttons and their function

The buttons described here are used only in the "Database" operating mode.
mark The completed line is marked, the cursor moves to the next line.
search This function enables the search according to search criteria in ascending or descending order.
sort This function enables sorting of records.
Sort criteria: Date / Time (Only for measurement, calibration, QC, and instrument data)
Up arrow: the records are arranged in ascending order (oldest date is at the top)
Down arrow: the records are arranged in descending order (youngest date is at the top).
Sort criteria: OpID (Only for measurement data)
Up arrow: the records are arranged in ascending order.
Down arrow: the records are arranged in descending order
Sort criteria: PatientenID (Only for measurement data)
Up arrow: the records are arranged in ascending order
Down arrow: the records are arranged in descending order
Sort criteria: Last name(Only for measurement data)
The records are arranged alphabetically according to the patients' names.
Up arrow: the records are arranged alphabetically in ascending order (for example, from top 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 B-36
Mark the date range Using this function allows for marking a random date range.
Export data The marked data range is exported to a PCMCIA card or through an interface.

Analyzer mode
Delete data Delete the marked data range.

e See the Reference Manual, chapter Database section Delete data!
Screen shot of the A list of all available forms is displayed (user-

database overview specific and standard). This selection remains the defined standard until a new form is
selected.
e See the Reference Manual, chapter Setup section Displays & reports > Measuring data
> Measurement > DB - Overview!
Optimize database The database is optimized. More disc-space is available.
Data export – PCMCIA card (for example)

A Printer cover
Figure B-37
2 Insert the PCMCIA card into the port.
Please be sure that the card is inserted correctly (see below).
A
B
A Front side B Reverse side
Figure B-38

Analyzer mode
3 Press [More functions] and then [Export data].

The following screen appears:
Figure B-39
4 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 B-40
Press these buttons to scroll through all parameters.
Select the marked entry - the patient's data is shown.

Analyzer mode
Measuring data
Figure B-41
Select the marked entry - the results screen associated with this
measurement is then displayed.
Calibration data
Figure B-42
Starting this function, the instrument displays an overview of the saved calibration
data.
Every line displays a short record of a calibration and contains the date, time, type of
calibration, as well as the parameter's condition after the calibration.
Select the marked entry - the results screen of this calibration is then
displayed.

Analyzer mode
QC data
Figure B-43
Starting this function, the 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 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, time,
operator ID (when available), and the corresponding status of the available
parameters.
Select the marked entry - the results display of the selected QC data are
displayed.
Instrument data
Figure B-44
Starting this function, an overview of the saved instrument data is displayed.
Select the marked entry - details about the entry are displayed.

Analyzer mode
Info
Use this function to retrieve the following information:
Figure B-45
Roche info
This displays the name, address, telephone number, and e-mail address that you
defined under:
h [Setup] > [Instrument] > [Roche info]

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 C-7!
Help
Use this function to retrieve online-help information.
Figure B-46

Analyzer mode
Sensor status
e See Chapter 10 Troubleshooting, section Sensor status on page D-15!
Counter overview
Figure B-47
Lifetime sample counter: Number of all measured samples since initial startup
Sample counter: Number of measurements
QC counter: Number of QC measurements
Cleaning counter: Number of measurements since the last automatic cleaning

Software overview
Software overview
A Software overview - Database

B Software overview - Info
Figure B-48

Software overview
Software overview - Setup
Part 1 Part 2
Figure B-49

Software overview

Maintenance C
9 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
September 2011
cobas b 121 system 9 Maintenance
Table of contents
Maintenance
In this chapter, all maintenance work is described that is necessary for trouble-free
operation of the instrument.

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-12
Using the empty C1 calibration solution 1 bottle as W waste container ....C-14
Installing the waste container .......................................................................C-14
Exchanging the fill port holder ...........................................................................C-15
Unscheduled ..............................................................................................................C-17
Instructions for Use · Version 12.0 C-3
9 Maintenance cobas b 121 system
Table of contents
Cleaning the bottle compartment ......................................................................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-22
Cleaning the measurement chamber ..................................................................C-24
Removing obstructions .......................................................................................C-25
Decontaminate the tubing paths ........................................................................C-26
Cleaning the bypass .............................................................................................C-27
Cleaning the screen .............................................................................................C-27
Surfaces ................................................................................................................C-27
Adjusting the screen ............................................................................................C-28
Additional maintenance procedures ........................................................................C-29
Annual maintenance ...........................................................................................C-29
Maintenance overview ..............................................................................................C-30
Maintenance scheduler .............................................................................................C-31

C-4 Instructions for Use · Version 12.0
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.
biological working materials. In addition, a face mask is required if there is a risk. 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.
Roche recommends following a decontamination procedure in addition to
regulations specific to the laboratory.
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 because this could cause
malfunctions in the electronics.
Do not use any type of bleaching agent. Exception: Roche Deproteinizer
Do not attempt to decontaminate any part 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 instrument:

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 page C-8 and Cleaning the drip tray and wash plate
on page C-17!

Decontamination
Touch screen
e See section Cleaning the screen on page C-27!
Surfaces of the instrument
e See section Surfaces on page C-27!
Tubing paths
e See section Decontaminate the tubing paths on page C-26!
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 paths
Avoid contact with skin. Always wear gloves! Danger of infection!
Protein remover o Potential dangers

(Roche Deproteinizer)
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 generous amounts of water, remove contaminated
clothing
After eye contract: rinse eyes with generous amounts of water, contact an eye
doctor
After drinking: drink large amounts of water, avoid vomiting, contact a doctor.

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]
Figure 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!
Check printer paper
Check daily to be sure that sufficient printer paper is available and exchange it if
necessary (paper is sufficient for about 200 measurements with 15 cm / measure-
ment).
e See section Check printer paper on page C-7!

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 and clean] > [Decont. sample port
module]
t
Figure C-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 C-3/1+2).
4 Close the flap to the syringe position (half-opened position).
5 Clean the tip of the needle (see Figure C-3/3).
(1) (2) (3)
Figure C-3
6 Close the flap.

Semi annual
Semi annual
Replacement of the peristaltic pump tubes
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 cover (tension lever).
3 Push the linear clamp (white plastic part) upwards (seeFigure C-4/1).
4 Remove the complete tubing set (tubing holder and tubing) (see Figure C-4/2).
(1) (2)
A Tension lever
B Pump head
C Linear clamp
Figure C-4
5 Check if the five rollers on the peristaltic 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.
The tubes may drip after disconnection. Remove excess fluids with a clean, absorbent
cloth.

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 (1 = low, 2 = normal, 3 = high). Make sure that the results agree with the
target values.
C1 calibration solution 1 and C2 calibration solution 2

Depending on the rate of measurement and/or the on-board stability, 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 stability, 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 PO2 zero point
o Solution for conditioning the Na+ electrode
o Cleaning solution
o Reference solution

Implementation: 1 Open the bottle compartment cover. The following screen appears:
Figure C-5
2 Open the docking mechanism and remove the bottles that are to be exchanged
(see Figure C-6).
Figure C-6
Dispose of the bottles according to local regulations (hazardous waste!)
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.
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 until it engages.

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

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 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. The bottle exchange image appears on the
display (see Figure C-7).
Figure C-7
2 Open the docking mechanism and remove the waste container.
Dispose of the waste container according to local regulations (hazardous waste!).
Empty the waste container

1 Place the bottle tool on the screw cap (Figure C-8).
Figure C-8
2 Open the screw cap by pressing the grips together and rotating them counter
clockwise (Figure C-9).
Figure C-9
3 When removing the screw cap, make sure that the green element inside the bottle
is not moved or removed (Figure C-10).
Figure C-10
Empty the waste material and decontaminate the container according to local 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!

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 C-11).
This sticker may not be reused – discard immediately.
A Remove the C1 sticker from the bottle at this Pull off the sticker beginning from the "W" sticker on the bottle of C1.
position. lower right corner (arrow) until the
sticker "Waste" is completely visible.
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, press this button.
A numerical keyboard appears on the display. Enter the approximate fill level in %
and confirm with the [OK] button.
If the W waste container is mistakenly reused as C1 calibration solution 1, a section of the

tubing must be exchanged!
ATTENTION Please contact technical support immediately!

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
module]
2 Rotate the fill port holder in the direction of the arrow (see the marking on the fill
port holder). It will come out of the axis and snap out of place (see
Figure C-12/1).

ATTENTION
3 Carefully remove the fill port holder from the needle (see Figure C-12/2).
(1) (2)
A Axis
Figure C-12

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 the bottom side is showing on top (see
Figure C-13).
Figure C-13
5 Snap the fill port holder evenly onto the axis.

ATTENTION
Figure C-14
6 Close the flap.
Dispose of the used fill port holder in accordance with local regulations (hazardous
waste!).

Unscheduled
Unscheduled
Cleaning the bottle compartment
1 Open the bottle compartment cover. The bottle exchange image appears on the
display.
e See Figure C-7 on page 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 C-14 and Installing the waste container on page C-14!
Do not scan a barcode!
h [More functions] > [System] > [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!

WARNING
module]

Unscheduled
A Drip tray B Wash plate
Figure C-15
2 Remove the sample drop cup and clean it according to local regulations (see
Figure C-16/1).
3 Open the bottle compartment cover.
4 Remove the red tube connector from the wash plate (see Figure C-16/2)
5 Push the wash plate down (to unlock) and pull it out (see Figure C-16/3). The
wash plate is locked when the plug is sticking out and cannot be removed.
(1) (2) (3)
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 tube plug.
8 Push the drip tray in.
9 Close the flap.

Unscheduled
Replacing printer paper

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 C-17).
6 Feed in the beginning of the paper according to the sticker on the inside of the
printer cover (see Figure C-18).
A printer lever
Figure 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 slit in the printer cover B
Figure C-18

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 C-19
A B B
A locking lever B MCon
Figure C-20

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, insert a dummy electrode instead.

MCon and the reference electrode may not be replaced with a dummy electrode.

Unscheduled
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.
WARNING calibration].
The parameter(s) are not calibrated and cannot be measured.
6 Prevent the formation of gas bubbles in the inner electrolyte of the electrodes
(see Figure C-21/1).
If necessary, remove air bubbles by holding the electrode vertically and by tapping
lightly with your fingernail against the electrode body (see Figure C-21/2).
(1) (2)
A free of air bubbles
Figure C-21
7 Insert the new electrode/MCon according to the colour code.

8 Push all electrodes slightly to the right so that they are lined up together without
gaps.
10 Inspect the electrical contact of the electrodes by checking if they fit tightly.
11 Scan the barcodes located on the inner packaging of each electrode or enter the
barcodes manually with the help of .
Figure C-22
12 The corresponding electrode begins blinking on the screen.

Unscheduled

14 Carefully close the measuring chamber and then the top cover.
15 A system calibration automatically starts.
16 After completing the calibration, perform a quality control measurement on all
three levels (1 = low, 2 = normal, 3 = high). While doing so, note the conformance
of the results with the target values
If a drift alarm of the PO2 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
Operating modes). If the drift alarm persists after 7 days, correct it by replacing the PO2
electrode.
After replacing the PO2 electrode, the 1-point calibration is performed at shorterintervals
during the first hour.
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 the situation,
start a "Calibration for "Ready".
Replacement of the reference electrode
1 Open the top cover and measurement chamber cover.

The following image appears on the display:
Figure C-23

3 Remove the reference electrode.

Unscheduled
A B
A locking lever
B reference electrode
Figure C-24
4 Pull off the white plug (see Figure C-25).
A A
A white plug
Figure C-25
5 Insert the new reference electrode.

6 Place the tube back into the tube guide slot.
Figure C-26

Unscheduled
If the tube does not lie precisely inside the guides, it may become pinched and thereby
prevent aspiration of the reference solution, resulting in calibration and measurement
errors.
7 Affix the white plug at the end of the reference electrode tube (see Figure C-25).
Push the plug in completely.

9 Inspect the electrical contact of the electrodes by checking if they fit tightly.
10 Scan the barcode on the packaging of the inserted electrodes or enter it manually
with the help of the [Data input] button.
11 The corresponding electrode begins blinking on the screen.

13 Close the measurement chamber and the top cover.
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 (1 = low, 2 = normal, 3 = high). Make sure that the results agree
with the target values.
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!
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.

6 A calibration is performed after a warm-up period.

Unscheduled
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.
The following picture is displayed on the screen:
Figure C-27
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.
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 & clean] > [Automatic routines]
13 Then call up a system calibration.

Unscheduled

Decontaminate the tubing paths
Press:
h [More functions] > [System] > [Wash & clean] > [Decontaminate all tubes]
1 Open the bottle compartment cover and remove bottles C1, C2, C3.
2 Fill the shutdown kit about halfway with Deproteinizer.
3 Insert the shutdown kit into space C3.
4 Connect the tubes of the set with the connectors from C1 and C2 (Figure C-28).
Figure C-28
5 Press the [Start] button to begin decontaminating the tubes.

Remove the remaining fluid from the tubes by briefly holding the tubes 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.
8 Replace the shutdown kit to the position of C3.
9 Connect the tubes of the set with the connectors from C1 and C2 (Figure C-28).
10 Press this button to begin cleaning the tubes.

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

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

13 Re-insert the bottles C1, C2, and C3.
e See section Exchanging the solutions on page C-10!
Cleaning the bypass
For cleaning excessive contamination in the bypass, press the following buttons:
h [More functions] > [System] > [Wash & cleaning] > [Decontaminate all tubes]
e For an exact description of the procedure, see Decontaminate the tubing paths on
page C-26!
Cleaning the screen
h [More functions] > [System] > [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 part 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 swabs or paper towel of gauze that
have been soaked in distilled water. Spray all removable covers (top 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

Unscheduled
Adjusting the screen
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.
Figure C-29
By pressing the [Test] button, you can check if the entire (black) area is active as a
touch-sensitive surface (see Figure C-30).
Figure C-30
By pressing the [Calibrate] button, you can use a pencil or other 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 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 C-31).

Additional maintenance procedures
Figure C-31
After leaving the window, the new correction values take effect.
Additional maintenance 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 : o Sample port module (incl. sample drip tray)

o Screen
o Surfaces
o Tube paths
Replace the following o Pump tube

components: o Needle seal
o Sample port
o Pump head
o Measuring chamber tube set
o Replace the entire tube system
Only for cobas b 121 systems with AutoQC module:
o AutoQC needle
o AutoQC washing port
o AutoQC washing tube

Maintenance overview
Test/check: 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 control measurement with all 3 levels (1 = low, 2 = normal,
3 = high)
Maintenance overview
h [More functions] > [System] > [Tools] > [Maintenance]

The overview shows a list of all maintenance entries.
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. 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.

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 D
10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
September 2011
cobas b 121 system 10 Troubleshooting
Table of contents
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.

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 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 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 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
Instructions for Use · Version 12.0 D-3
10 Troubleshooting cobas b 121 system
Table of contents
3070 Hardware error .......................................................................................... D-13

Electrode status ......................................................................................................... D-14
Sensor status ....................................................................................................... D-15

D-4 Instructions for Use · Version 12.0
Troubleshooting - general
Troubleshooting - general
fter use, components of the cobas b 121 system, including tubing, waste 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.
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 chapter
System, section Tools > Diagnostics!
System stops
System stops should be corrected as quickly as possible!

ATTENTION
For example:
Figure D-1

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 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 actions are currently
performed. When changing to the menu "System" during a "System stop", the "System
stop" will not be terminated, but reactivated when the menu "System" is closed again.
If e.g. there is a change from a "Temperature system stop" to the menu "System" and
the menu "System" is closed again, the analyzer will display the system stop
"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 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 System calibration
o Waste container fill level measurement
o Aspirate Mix1

List of system stops
3001 Measuring chamber cover open
Cause 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
Remedy o Close measuring chamber cover

o Check the measuring chamber cover sensor (
h [More functions] > [System] > [Test] > [Control sensors] > [Monitoring sensors]
o Check cable
o In case of recurrence, call technical support.
Consequence actions o After opening for longer than 5 seconds: Warm-up

o Wash
o After changing (an) electrode(s): system calibration
3002 Bottle compartment cover open
Cause o The bottle compartment is open

o The bottle compartment cover micro switch is defective
Remedy o Close bottle compartment cover

o Check to be sure that the bottles are inserted completely
o Check the bottle compartment cover micro switch
o In case of recurrence, call technical support
Consequence actions o C1 changed: prepare solution C1, fill FMS reservoir, conductivity calibration
o C2 changed: prepare solution C2, fill FMS reservoir, conductivity calibration
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 measurement

3003 Flap open
Cause 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
Remedy o Close flap

o Check function of the flap detection board
Consequence actions o Wash
3004 Analyzer error
Cause o The measurement progress was incorrect
Remedy o Press the [OK] button

o Switch the analyzer off/on
o In case of recurrence, call technical support (the electronics is defective).
3005 Memory error
Cause o Fundamental software functions can not be performed (memory problems, file
system problems), the correct operation of the instrument can not be guaranteed
Remedy o Press the [Reboot] button

3006 Temperature error
Cause 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: 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
o A temperature sensor is defective
Remedy o Reduce / raise the room temperature


3009 Conductivity cal. error
Cause o The conductivity calibration has failed
Remedy o Press the [OK] button (start a system calibration)

Consequence actions o System calibration
3010 AQC cover open
Cause o The AutoQC cover is open

o The AutoQC cover sensor (Hall sensor) is defective
Remedy o Close the AutoQC cover

o Check the AutoQC cover sensor
h [More functions] > [System] > [Test] > [Control sensors] > [Monitoring Sensors]
3012 User system stop
Cause 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.
Remedy o Press the [OK] button (terminate the "User system stop")
Consequence actions o Aspirate Mix1
3013 Fluid pack switch
Cause 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
Remedy o Close docking mechanism Fluid Pack C3

o Check micro switch
Consequence actions o Auto-preparing of Fluid Pack C3 solutions

3014 Fill level alarm
Cause o The solutions C1, C2 and/or C3 are empty (below alarm level) or are set to
"empty"
o The Waste container W is full (above alarm level)
o The expiry date of the solutions is exceeded
o The on-board lifetime of the solutions is exceeded (C1/C2 = 28 days;
C3 = 42 days)
Remedy o Change solutions C1, C2 and Pack C3

o Change or empty the Waste container W according to the instructions
Consequence actions o C1 changed: prepare solution C1, fill FMS reservoir, conductivity calibration
o C2 changed: prepare solution C2, fill FMS reservoir, conductivity calibration
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 measurement
3015 Waste container full
Cause o Waste container is full
Remedy o Change or empty Waste container according to the instructions
Consequence actions o Waste container fill level measurement
3016 Waste container switch
Cause o The Waste container (W) has been removed

o The Waste container micro switch is defective
Remedy o Reinsert the Waste container

o Check Waste container micro switch
Consequence actions o Waste container fill level measurement

3017 Pump cal. error
Cause o The pump calibration (rotational speed adjustment of the pump) failed
Remedy o Check PP tube

o Check fill levels of solutions C1 and C2
o Check under:
h [More functions] > [Test] > [Valves & Aggregates] > [Peristaltic pump]
if values inside the following limits are displayed:
O Pump volume: 40 - 70µl
O FMS volume: 920 - 1050µl
o If the displayed values are outside of the limits, perform a FMS volume
determination and correct the FMS volume value.
Consequence actions o Aspirate Mix1

3018 Sample detection failed
Cause o The sample detection with sample sensors (SS1 and SS2) failed
o The sample sensor board is defective
Remedy o Press the [OK] button (start a Sample sensor calibration)

o Check fill level of solution C2
Consequence actions o Sample sensor calibration

o Fill FMS reservoir
o Wash
3019 Out of operation
Cause o The instrument has been taken out of operation
Remedy o Perform the installation procedure

e See Chapter 3 Installation and shutdown, section Installation on page A-23!
3020 Economy mode
Cause o The economy mode has been started manually or automatically
Remedy o Manual termination by pressing the [Abort] button

o Automatic termination by preset stop time

3023 Waste Container level undefined
Cause o The actually measured waste container fill level differs by more than 4 cm from
the calculated/set value
Remedy o The waste container fill level must be set roughly (+/- 4 cm) corresponding to the
actual fill level in the waste container
o Change the Waste Container W

o Waste container fill level measurement
3024 Flash memory full
Cause o The internal flash memory has less than 8 KB space left for saving additional data
Remedy o Delete data records (database entries, protocols, log data) in order to free up
additional memory
e See Chapter 8 Operating modes, section Database on page B-60 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
Cause o The PCMCIA card has less than 8 KB space left for saving additional data
Remedy o Delete data records from the PCMCIA card in order to free up additional memory
capacity.
In order to actually free up additional memory, the functions "Delete data" and "Optimize
database" have to be activated in this order
ATTENTION
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 the card
o Format the PCMCIA card in the instrument.
h [More functions] > [System] > [Test] > [PC Components] > [PCMCIA card] >
[More functions]
e See Reference Manual, chapter System section Test > PC Components > PCMCIA card!

3026 Data object error
Cause o The data access onto objects in the analyzer area failed, the correct operation of
the instrument can not be guaranteed
Remedy o Press the [Reboot] button.

3028 Hardware error
Cause o Internal bus system does not respond correctly
Remedy o Wait! These errors are automatically self-repaired.

3029 Hardware error
Cause o 24 V supply voltage is not OK

3070 Hardware error
Cause o Electronic components do not respond properly


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).
Figure 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).
e The exact description of the short texts can be found in the Reference Manual, chapter
Troubleshooting.
Figure D-3
Pressing this button lists suggestions for the fault removal (see below).
Figure D-4

Electrode status
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:
Figure D-5
e An exact description of this function can be found in the Reference Manual, chapter
System, section Tools > Diagnostics!
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 left.
The following information about the selected sensor will be displayed:
Figure D-6
Pressing this button the printout of the report can be started.

Electrode status

Appendix E
11 List of consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
September 2011
cobas b 121 system 11 List of consumables
Table of contents
List of consumables
In this chapter, all nessary consumables and order numbers are listed.

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

Instructions for Use · Version 12.0 E-3
11 List of consumables cobas b 121 system
Table of contents

E-4 Instructions for Use · Version 12.0
Order information
Order information
To measure the respective parameter following products are required:
Electrodes
Parameter
Cl- Na+ K+ Ca2+ PCO2 PO2 pH tHb SO2
Chloride Electrode X + + + + + + + +
03111571180 (BP1729)
Sodium Electrode + X + + + + + + +
03111598180 (BP1730)
Potassium Electrode + + X + + + + + +
03111628180 (BP1731)
CalciumElectrode + + + X + + + + +
03111644180 (BP1732)
PCO2 Electrode + + + + X + + + +
03111679180 (BP1733)
PO2 Electrode + + + + + X + + +
03111695180 (BP1734)
pH Electrode + + + + + + X + +
03111717180 (BP1735)
Reference Electrode 03111873180 X X X X X X X X X
(BP2081)
MCon X X X X X X X X X
03144062001 (BP2613)
SCon X X X X X X X X X
03260909184 (BP2608)
Dummy Electrode(a) + + + + + + + + +
03111849035 (BP1959)
Tabelle E-1
(a) Dummy or electrode has to be used for proper filling of the measuring chamber
X Has to be installed
+ Dummy or electrode has to be used for proper filling of the measuring chamber

Order information
Solutions
Paramenter
- + + 2+
Cl Na K Ca PCO2 PO2 pH tHb SO2
C3 Fluid Pack X X X X X X X X X
03144038001 (BP2655)
C1 Calibration Solution X X X X X X X X X
03144046001 (BP2661)
C1 Calibration Solution X X X X X X X X X
03144020001 (BP2662)
W Waste X X X X X X X X X
03144054001 (BP2663)
Tabelle E-2
X Has to be installed
QC material
Parameter
- + + 2+
AUTO-TROL TS+. Level 1 O O O O O O O O O
03321223001 (BP9106)
03321231001 (BP9107)
03321240001 (BP9108)
COMBITROLTS+. Level 1 O O O O O O O O O
03321258001 (BP9109)
COMBITROL TS+. Level 2 O O O O O O O O O
03321266001 (BP9110)
COMBITROLTS+. Level 3 O O O O O O O O O
03321274001 (BP9111)
TS/MSS Verification Material O O O O O O O O O
03354601001 (BP9407)(a)
Tabelle E-3
(a) Only for USA available!
O Can be used

Order information
Accessories
Parameter
- + + 2+
Deproteinizer O O O O O O O O O
03110435180 (BP0521)
Adapter for Capillaries O O O O O O O O O
03069931001 (BP0959)
Ampoule Adapter O O O O O O O O O
03066762001 (BP1938)
Clot Catcher (a) O O O O O O O O O
03112012180 (BP2243)
Clot Catcher PRO(b) O O O O O O O O O
05689856001
Cl-Cleaning Kit O - - - - - - - -
03112098035 (BP2276)
Adapters for Sample Container O O O O O O O O O
03112101180 (BP2277)
Caps for Roche MICROSAMPLER O O O O O O O O O
03112152180 (BP2288)
Printer Paper O O O O O O O O O
03113353180 (HP0070)
Roche MICROSAMPLER PROTECT, non sterile O O O O O O O O O
05772494001 (200 pcs.)
Roche MICROSAMPLER PROTECT, sterile O O O O O O O O O
05772583001 (50 pcs.)
Roche MICROSAMPLER PROTECT, with accessories O O O O O O O O O
05772591001(c)
Capillary Tubes. ~ 115 µL O O O O O O O O O
03113507035(MG0002)
Capillary Tubes. ~ 200 µL O O O O O O O O O
03113477180 (MC0024)
Plastic Capillary Tubes, ~ 140 µL O O O O O O O O O
05174791001
BS2 Blood Sampler O O O O O O O O O
03113493035 (MC0028)
Sterile Capillary Holder - - - - O O O - -
05174830001
Caps for Capillary Tubes O O O O O O O O O
03113647035 (RE0410)
Customer Accessory Kit O O O O O O O O O
04975600001
Tabelle E-4
(a) The Clot Catcher is not suitable for the cobas b 121 system syringe mode.
(b) The Clot Catcher PRO is not suitable for the cobas b 121 system syringe mode.
(c) Only for USA available!
O Can be used
- Do not use!

Order information

Index F
12 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-3
September 2011
cobas b 121 system Index
Index
Numerics Bottles
– Insertion of bottles, A-32
1P calibration, B-47 – Remove bottles, A-38
1P calibration (1P cal), B-46 Brands, 4
2P calibration (2P cal), B-46 Buttons, B-54
2P calibration incl. O2, B-47 – Important buttons on the screen, A-12
2P calibration without O2, B-47 Bypass
2P O2 calibration, B-47 – Cleaning, C-27
A C
Abbreviations, 10 C1 calibration solution 1

Accessories, A-24 – Exchange, C-10
– List of consumables, E-7 C2 calibration solution 2
Adjusting the screen, C-28 – Exchange, C-10
Analyzer mode, B-56 C3 fluid pack
– "Ready" screen, B-56 – Exchange, C-10
– Database, B-60 Calculated parameters, B-53
– Calibration data, B-64 Calculated parameters at the patient’s temperature, B-54
– Data export, B-62 Calibration, B-43
– Description of the buttons and their function, B-61 – Automatic calibrations, B-45
– Instrument data, B-65 – 1P calibration (1P cal), B-46
– Measuring data, B-64 – 2P calibration (2P cal), B-46
– More functions of the database, B-61 – Recalibration, B-46
– Patient data, B-63 – System calibration, B-45
– QC data, B-65 – Calibration progress indicator, B-45
– Info, B-66 – General, B-45
– QC measurement, B-59 – User activated calibrations, B-46
– Quick access, B-58 – 1P calibration, B-47
– Setup, B-59 – 2P calibration incl. O2, B-47
– System, B-58 – 2P calibration without O2, B-47
Annual maintenance, C-29 – 2P O2 calibration, B-47
Application area, A-12 – Calibration for "Ready", B-47
Automatic calibrations, B-45 – Conductivity calibration, B-47
– 1P calibration (1P cal), B-46 – System calibration, B-47
– 2P calibration (2P cal), B-46 Calibration data, B-64
– Recalibration, B-46 Calibration for "Ready", B-47
– System calibration, B-45 Calibration procedure, A-14
AutoQC Calibrations, A-50
– AutoQC measurement, B-35 Capillary mode, B-19
– Inserting AutoQC mats, B-29 Capillary tubes, B-6
– Material assignment, B-29 Check fill levels, C-7
– Setting QC times, B-31 Check printer paper, C-7
Checking the barometer value, A-28
Classification (according IEC/ISO), A-53
B Clean needle and fill port, C-8
Cleaning the bottle compartment, C-17
Barcode scanner, A-19 Cleaning the bypass, C-27
– Specifications, A-54 Cleaning the drip tray and wash plate, C-17
Bottle compartment, A-18 Cleaning the measurement chamber, C-24
– Cleaning, C-17 Cleaning the screen, C-27

Instructions for Use · Version 12.0 F-3
Index cobas b 121 system
COM 1, A-19 – Temperature / humidity / stability, A-51

COM 2, A-19 – Troubleshooting, D-14, D-15
Conductivity calibration, B-47 Empty the waste container, C-12
Consumable list, E-3 Environmental parameters, A-51
– Accessories, E-7 – Temperature / humidity / stability, A-51
– Electrodes, E-5 Exchanging the fill port holder, C-15
– QC material, E-6 Exchanging the solutions, C-10
– Solutions, E-6 – C2 calibration solution 2, C-10
Contact addresses, 4 – C3 fluid pack, C-10
Copyright, 3
Counter overview, B-67
F
D Fill levels, B-66

– Check fill levels, C-7
Data export Fill port
– Database, B-62 – Clean fill port, C-8
Data input – Remove needle and fill port, A-42
– Measuring pocedure, B-21 Fill port holder
Database, B-60 – Exchange, C-15
– Calibration data, B-64 Flap, A-18
– Data export, B-62
– Description of the buttons and their function, B-61
– Instrument data, B-65 G
– Measuring data, B-64
– More functions of the database, B-61 General description, A-9
– Patient data, B-63 General notes, A-12
– QC data, B-65
Decontamination, A-15, C-5
– Decontaminate the surfaces, C-27 H
– Decontaminate the tubing paths, C-26
– Recommended decontaminant, C-6 Help, B-66
– Sample port module, C-5 How to Use This Manual, 7
– Surfaces of the instrument, C-6
– Touch screen, C-6
– Tubing paths, C-6 I
Default and input values, A-49
Dimensions, A-53 Important information, A-5
Disposal of waste water, bottles, electrodes, and Info, B-66
the instrument, A-15 – Counter overview, B-67
Document information, 3 – Fill levels, B-66
Drip tray – Help, B-66
– Cleaning, C-17 – Roche info, B-66
– Sensor status, B-67
– Version numbers, B-66
E Input parameters, B-54
– Measurement information, B-53
Edition, 4 – Patient information, B-52
Edition notice, 3 Installation, A-23, A-24
Electrodes – Accessories, A-24
– Handling electrodes, A-16 – Attach power cord and barcode scanner, A-24
– Insert electrodes, A-34 – Attach pump tube, A-29
– Insertion of the reference electrode, A-35 – AutoQC module, A-29
– List of consumables, E-5 – Begin installation routines, A-37
– Replacement of the electrodes and the MCon, C-20 – Check tubes at V2 and V9, A-28
– Sensor status, D-15 – Check/Activate the parameters tHb and SO2, A-27

F-4 Instructions for Use · Version 12.0
– Checking the AutoQC module, A-28 M

– Checking the barometer value, A-28
– Insert electrodes, A-34 Maintenance, C-3
– Insert FMS tubes, A-29 – Additional maintenance procedures, C-29
– Insert needle and fill port holder, A-30 – Annual maintenance, C-29
– Insertion of bottles, A-32 – Annual maintenance, C-29
– Insertion of printer paper, A-31 – Daily, C-7
– Insertion of the reference electrode, A-35 – Check fill levels, C-7
– Installing the AutoQC module, A-25 – Check printer paper, C-7
– Location, A-23 – Decontamination, C-5
– Quality control, A-37 – General, C-5
– Select language, A-27 – Maintenance Overview in the software, C-30
– Setting the date and time, A-27 – Maintenance scheduler, C-31
– Switch on, A-27 – Sample-dependent maintenance procedures, C-10
Installation and shutdown, A-21 – Exchanging the fill port holder, C-15
Instructions for Use – Exchanging the solutions, C-10
– Abbreviations, 10 – Waste material, C-12
– Conventions used in this manual, 7 – Semi annual, C-9
– How to use, 7 – Replacement of the peristaltic pump tubes, C-9
– IVD symbols, 8 – Unscheduled, C-17
– Operating safety information, A-6 – Adjusting the screen, C-28
– Other symbols, 9 – Cleaning the bottle compartment, C-17
– Symbols, 7 – Cleaning the bypass, C-27
– Where to find information, 7 – Cleaning the drip tray and wash plate, C-17
Instrument – Cleaning the measurement chamber, C-24
– Temperature / humidity / stability, A-51 – Cleaning the screen, C-27
Instrument data, B-65 – Decontaminate the surfaces, C-27
Intended use, 3 – Decontaminate the tubing paths, C-26
Interface, A-19 – Removing obstructions, C-25
– Barcode scanner, A-19 – Replacement of the electrodes and the MCon, C-20
– COM 1, A-19 – Replacement of the reference electrode, C-22
– COM 2, A-19 – Replacing printer paper, C-19
Interferences, B-9 – Weekly, C-8
– Effect of the substances on ISE, B-12 – Clean needle and fill port, C-8
– Effect of the substances on pH, BG, B-9 Manual QC measurement, B-34
– tHb/SO2, B-16 Measured parameters, B-53
Introduction, A-11 Measurement, B-3
IT Security Advisory, A-7 – Preanalytics, B-5
– Security precautions, A-7 Measurement and calibration procedure, A-14
IVD symbols, 8 – Calibration procedure, A-14
– Measurement evaluation, A-14
– Measurement procedure, A-14
L Measurement chamber, A-18
– Cleaning, C-24
List of consumables, E-3 Measurement evaluation, A-14
– Accessories, E-7 Measurement procedure, A-14
– Electrodes, E-5 Measurement report, B-22
– QC material, E-6 Measurement times of the samples, A-49
– Solutions, E-6 Measuring data, B-64
List of system stops, D-7 Measuring pocedure, B-17
Location, A-23 – Capillary mode, B-19
– Data input, B-21
– Results display / measurement report, B-22
– Syringe mode, B-18
Multirules, B-36

N – Sample collection, B-5

– Sample collection containers, B-6
Needle – Sample handling, B-8
– Clean needle, C-8 Preface, 7
– Remove needle and fill port, A-42 Printer, A-17
– Check printer paper, C-7
– Replacing printer paper, C-19
O – Specifications, A-53
Product data, A-53
Obstructions – Classification (according IEC/ISO), A-53
– Removing obstructions, C-25 – Dimensions, A-53
Operating instructions, A-12 – Electrical data, A-53
Operating modes, B-49 – Weight, A-53
– Analyzer mode, B-56 Pump, A-18
– Database, B-60 – Remove the pump tube, A-41
– Info, B-66 – Replacement of the peristaltic pump tubes, C-9
– QC measurement, B-59
– Quick access, B-58
– Setup, B-59 Q
– System, B-58
– General, B-51 QC concept
– Software overview, B-68 – General, B-25
– User Interface, B-51 QC consequences, B-38
Operating safety information, A-6 QC data, B-65
Operation QC error, B-38
– Calibration, B-43 QC material
– Measurement, B-3 – List of consumables, E-6
– Quality control, B-23 – Material setup, B-28
Operator’s Manual – Inserting AutoQC mats, B-29
– version, 3 – Material assignment - AutoQC materials, B-29
Order information, E-5 – Setting QC times, B-31
– Accessories, E-7 – Temperature / humidity / stability, A-52
– Electrodes, E-5 QC measurement, B-34, B-59
– QC material, E-6 – AutoQC measurement, B-35
– Solutions, E-6 – Manual QC measurement, B-34
QC troubleshooting, B-39
QC unlock, B-38
P – QC error, B-38
– QC warning, B-38
Parameter, B-52 QC warning, B-38
– Additional calculated parameters, B-54 Quality control, B-23
– Calculated parameters, B-53 – General, B-25
– Calculated parameters at the patient’s – General QC concept, B-25
temperature, B-54 – Important information concerning the analysis of
– Input parameters, B-54 QC measurement results, B-27
– Input parameters - measurement information, B-53 – Material setup, B-28
– Input parameters - patient information, B-52 – Inserting AutoQC mats, B-29
– Measured parameters, B-53 – Material assignment - AutoQC materials, B-29
– Parameter appearance on the "Ready" screen, B-52 – Setting QC times, B-31
Patient data, B-63 – Multirules, B-36
Performance data, A-47 – QC consequences, B-38
– Measured parameters, A-47 – QC measurement, B-34
Plasma – AutoQC measurement, B-35
– Sample handling, B-8 – Manual QC measurement, B-34
Power supply, A-18 – QC troubleshooting, B-39
Preanalytics, B-5 – QC unlock, B-38

– QC error, B-38 – Serum, B-8

– QC warning, B-38 – Whole blood, B-8
Quick access, B-58 Sample port module
– Decontamination, C-5
Sample throughput, A-49
R Sample types, A-50
Sample volume, A-50
Ready screen, B-56 Samples
Recalibration, B-46 – Handling samples, A-15
Reference electrode Scheduler
– Replacement, C-22 – Maintenance scheduler, C-31
Remove needle and fill port, A-42 Screen, A-17
Remove the electrodes, A-41 – Cleaning the screen, C-27
Remove the printer paper, A-42 – Specifications, A-54
Remove the waste container (W waste container), C-12 Sensor status, B-67, D-15
Removing obstructions, C-25 Serum
Replacement of the electrodes and the MCon, C-20 – Sample handling, B-8
Replacement of the peristaltic pump tubes, C-9 Setting QC times, B-31
Replacement of the reference electrode, C-22 Setup, B-59
Replacing printer paper, C-19 Shutdown, A-21, A-38
Results display, B-22 – Insert the shutdown kit and connect it, A-39
Reverse side, A-19 – Less than 24 hours, A-38
– Interface, A-19 – Longer than 24 hours, A-38
– Warning and identification labels, A-20 – Remove bottles, A-38
Revision history, 3 – Remove needle and fill port, A-42
Roche info, B-66 – Remove the electrodes, A-41
Roche MICROSAMPLER PROTECT, B-7 – Remove the printer paper, A-42
– Remove the pump tube, A-41
– Remove the shutdown kit, A-40
S – Remove the tube under V1 and V2, A-42
– Remove the V2 and V9 tube ends from the guides, A-39
Safety Information – Remove the waste container, A-40
– IT Security Advisory, A-7 – Return the V2 and V9 tube ends to the guides, A-40
– Security precautions, A-7 – Shutting down the AutoQC module, A-43
Safety information, A-3 – Uninstall the AutoQC module, A-43
– Important information, A-5 Software
Safety instructions for specific dangers, A-15 – version, 3
– Decontamination, A-15 Software overview, B-68
– Disposal of waste water, bottles, electrodes, and Solutions
the instrument, A-15 – Exchanging the solutions, C-10
– Handling electrodes, A-16 – C1 calibration solution 1, C-10
– Handling samples, A-15 – C2 calibration solution 2, C-10
– Handling solutions, A-15 – C3 fluid pack, C-10
Sample collection, B-5 – Handling solutions, A-15
– Acceptable anticoagulants, B-5 – List of consumables, E-6
– Especially for tHb, SO2 and Hct measurement, B-5 – Temperature / humidity / stability, A-52
– Sample acquisition, B-5 Specifications, A-45
Sample collection container accessories, B-7 – Barcode scanner, A-54
– Clot Catcher, B-7 – Calibrations, A-50
– Clot Catcher PRO, B-7 – Default and input values, A-49
Sample collection containers, B-6 – Measurement times of the samples, A-49
– Capillary tubes, B-6 – nvironmental parameters, A-51
– Roche MICROSAMPLER PROTECT, B-7 – Performance data, A-47
– Syringes, B-6 – Printer, A-53
Sample handling, B-8 – Product data, A-53
– Plasma, B-8 – Sample throughput, A-49

– Sample types, A-50 – Conductivity calibration, B-47

– Sample volume, A-50 – System calibration, B-47
– Screen, A-54 User interface, B-51
Surfaces – Buttons, B-54
– Decontamination, C-27 – Parameter, B-52
Surfaces of the instrument
Symbols, 7, 9 V
Syringe mode, B-18
Syringes, B-6 Version numbers, B-66
System, B-58
System calibration, B-45, B-47
System description, A-17 W
– Bottle compartment, A-18
– Flap, A-18 Warning and identification labels, A-20
– Measurement chamber, A-18 Wash plate
– Power supply, A-18 – Cleaning, C-17
– Printer, A-17 Waste material, C-12
– Pump, A-18 – Empty the waste container, C-12
– Reverse side, A-19 – Installing the waste container, C-14
– Screen, A-17 – Remove the waste container (W waste container), C-12
System stops, D-5 – Using the empty C1 calibration solution 1 bottle as
– List of system stops, D-7 W waste container, C-14
Whole blood
– Sample handling, B-8
T
Temperature / humidity / stability, A-51

– Electrodes, A-51
– Instrument, A-51
– QC material, A-52
– Solutions, A-52
tHb/SO2
– Interferences, B-16
Touch screen
– Adjusting the screen, C-28
Troubleshooting, D-3
– Electrode status, D-14
– Sensor status, D-15
– General, D-5
– QC troubleshooting, B-39
– System stops, D-5
– List of system stops, D-7
Tubing paths
– Decontamination, C-6, C-26
User activated calibrations, B-46

– 1P calibration, B-47
– 2P calibration incl. O2, B-47
– 2P calibration without O2, B-47
– 2P O2 calibration, B-47
– Calibration for "Ready", B-47


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cobas b 121 system

Instructions for Use

Roche Diagnostics GmbH

Manual Version Software Version Revision date Changes

cobas b 121 system

This product complies with the requirements in the guideline for

© 2011, Roche Diagnostics GmbH. All rights reserved

Roche September 2011

responsibility for errors or omissions which may appear in this document.

Manufacturer Roche Diagnostics GmbH

Revision 12.0, September 2011

Roche September 2011

Revision History 3 6 Quality control

Roche September 2011

How to use this manual

Where to find information

Conventions used in this manual

Roche September 2011

In Vitro Diagnostic Medical Device

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

Attention, consult accompanying documents

Please consult instructions for use

Serial number (model plate)

Roche September 2011

Do not use if package damaged

Fragile. Handle with care

Handle with care

Valid only for Roche MICROSAMPLER PROTECT:

Other symbols The following symbols are listed as additional information:

Roche September 2011

"Grüner Punkt" (in Germany)

Protective gloves, protective goggles and suitable protective

Abbreviations The following abbreviations are used:

Roche September 2011

Roche September 2011

Roche September 2011

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

In this chapter Chapter 1

Roche September 2011

Roche September 2011

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

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

Roche September 2011

Operating safety information

Roche September 2011

Roche September 2011

Roche September 2011

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

In this chapter Chapter 2

Barcode scanner ............................................................................................. A-19

Roche September 2011

The instrument is currently available in the following configuration:

Roche September 2011

The instrument is designed to measure BG / ISE / tHb/SO2 in whole blood. The

The instrument should be powered on at all times!

Prevent fluids leaking inside the analyzer.

Important buttons on the screen

Operating mode "Analyzer"

Operating mode "Database"

Operating mode "Setup"

Roche September 2011

Roche September 2011

Measurement and calibration procedure