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Instructions For Use Cobas B 121 en Rev12 GRIPS
Instructions For Use Cobas B 121 en Rev12 GRIPS
©2011 Roche
Revision History
Edition notice
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.
Copyright
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
Edition
Table of contents
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
Roche September 2011
Instructions for Use · Version 12.0 5
cobas b 121 system
Index Part F
Index F-3
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.
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.
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
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
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.
Catalogue number
(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
Symbol Description
Do not reuse
Keep dry
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).
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.
Symbol Description
Store upright
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
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!
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.
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.
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.
General description
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
General notes
Application area
Operating instructions
Buttons Description
Button "Info"
More functions
Buttons Description
Confirm
Cancel
Activate / deactivate
Start action
e For more information, see Chapter 8 Operating modes, section Buttons on page B-54!
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.
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).
e For more information, see Chapter 6 Quality control!
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!
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).
Handling solutions
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
System description
Visual identification
A J
I
B
H
C G
D
E
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.
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
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.
Figure A-3
Reverse side
Interface
A B C D
Figure A-4
*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.
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)
Roche September 2011
Instructions for Use · Version 12.0 A-19
2 General description cobas b 121 system
System description
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).
A Identification label
Figure A-7
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.
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
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.
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.
Accessories
The following parts are delivered as standard equipment with the instrument:
Installation
Figure A-8
A Docking mechanism
Figure A-9
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)!
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
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.
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.
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:
Press:
h [Setup] > [Times & intervals] > [Date/Time]
e For a detailed description, see Reference Manual chapter Setup!
Press:
h [Setup] > [Parameters] > [Misc. settings] > [Act. / deact. f. measurement]
e For a detailed description, see Reference Manual chapter Setup!
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!
Press:
h [Setup] > [Instrument] > [AutoQC]
9. Installation
Press:
h [More functions] > [System] > [Tools] > [Installation]
o Follow the instructions on the screen!
Figure A-15
Figure A-16
Pump closed
A Tension lever C Linear clamp
B Pump head
Figure A-17
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).
4 Snap the fill port holder evenly onto the axis (see Figure A-19/3).
Figure A-19
The printer paper is heat sensitive on one side only. Please make sure that you insert the
paper roll correctly.
A Printer lever
Figure A-20
6 Close the printer cover and feed the paper outward through the slit in the printer
cover.
Figure A-21
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).
Figure A-22
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.
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
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).
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.
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).
A A
Figure A-29
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
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.
Shutdown
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.
1. Remove bottles
Open the bottle compartment cover and remove bottles C1, C2 and C3.
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
Figure A-33
Figure A-34
Remove the remaining fluid from the tubes of the shutdown kit by briefly holding the tubes
vertically, allowing the fluid to run back into the container.
2 Start the procedure for emptying the tubes by pressing the [Start] button.
Figure A-35
A Tension lever
B Pump head
C Linear clamp
Figure A-36
A Locking lever B
Figure A-37
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).
Figure A-38
Figure A-39
If available (option):
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.
A Unlocking knob
Figure A-40
2 Remove both tube ends in the bottle compartment from the docking port.
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.
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.
Figure A-43
Specifications
In this chapter, the performance data, as well as product and environmental data are
described.
Performance data
Measured parameters
Sample throughput
Sample volume
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
Environmental parameters
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.
Electrodes
Operating conditions
o Ambient temperature +15 °C to +33 °C
o Measurement chamber temp. +37 °C ± 0,2 °C
o Relative humidity 20 - 95%, if T > +15 °C to ≤ +31 °C
20 - 90%, if T > +31 °C to < +33 °C
Solutions
Operating conditions
o Ambient temperature +15°C to +33 °C
o Relative humidity 20 - 95%, if T > +15 °C to ≤ +31 °C
20 - 90%, if T > +31 °C to < +33 °C
QC material
Product data
Electrical data
Protection class: I
Overvoltage category: II
Contamination level: 2
Dimensions
Weight
Printer
Screen
Barcode scanner
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
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.
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.
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.
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.
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.
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
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
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.
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.
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.
Syringe mode
Improper heparinization of syringes with liquid heparin may cause false results. ISE
parameters are particularly susceptible.
Figure B-3
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
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
1 Open the flap to the labelled capillary position (completely open position).
The aspiration process is started.
Open the flap slowly to avoid splattering small drops of liquid that are on the needle tip.
Figure B-6
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!
Figure B-7
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!
Data input
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
Go to additional views
Start a printout
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.
e See Reference Manual, Chapter Setup!
h [Setup] > [Displays & reports] > [Measuring data] > [Measurement report]
e See Reference Manual, Chapter Setup!
Figure B-10
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.
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.
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).
For example (2P calibration interval: 12 hours):
24 hours
Figure B-11
Complete at least two quality control tests on different levels once daily or more often
in accordance with local regulations.
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.
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.
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!
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
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.
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.
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.
Figure B-14
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.
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
The assignment of the mat can be freely defined by selecting or deselecting individual
ampoules.
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).
Select the day from the "Day of Week" list on which the QC measurement
should be performed.
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]).
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.
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
QC measurement
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).
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).
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!
Figure B-20
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.
Figure B-22
AutoQC measurement
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:
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".
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
Rule Description
1. 12σ QC measurement value (m) is outside x ± 2σ
2. 13σ QC measurement value (m) is outside x ± 3σ
3. (2 von 3)2σ Two of three QC measurement values are outside x ± 2σ
Observation time period: 1 series (within run)
NT = 3
4. 22σ 2 QC measurement values (m) are outside x ± 2σ
Observation time period: 2 series
NL ≥ 2
5. 61σ 6 QC measurement values (m) are outside x ± 1σ
Observation time period: 3 series
NT ≥ 6
6. 9m QC measurement values (m) are on the same side as the mean
value
Observation time period: 5 series
NT ≥ 9
2SD range Defined target values (ranges)
Table B-4
QC consequences
Figure B-24
QC unlock
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).
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!
QC troubleshooting
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.
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.
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].
3 Repeat the QC measurement (with same material / level combination)
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.
4 Repeat the QC measurement (with same material / level combination)
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!
Calibration
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.
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.
Recalibration
This calibration is a 1 point calibration (without O2) performed after every
measurement taken.
Figure B-26
Using the [line up] / [line down] buttons you may now select the desired calibration.
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.
Operating modes
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:
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").
A I
D E F G H
Figure B-27
e For more detailed information refer to the respective chapters in these Instructions for Use
as well as the Reference Manual.
Parameter
Additional
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
Buttton Description
button "Info"
More functions
confirm
cancel
activate / deactivate
start
add
remove
password
data input
details
Analyzer mode
"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".
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).
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:
Figure B-31
System
Figure B-32
Quick access
Using these functions, you can start the following actions or change the following
settings:
Figure B-33
QC measurement
Setup
Figure B-34
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!
Database
Figure B-35
You can activate the desired database directly by pressing the respective line on the
screen.
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 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.
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.
A Printer cover
Figure B-37
A
B
Figure B-38
Figure B-39
Patient data
Figure B-40
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.
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
Select the marked entry - details about the entry are displayed.
Info
Figure B-45
Roche info
This displays the name, address, telephone number, and e-mail address that you
defined under:
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
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
Figure B-48
Part 1 Part 2
Figure B-49
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
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.
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. 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.
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!
e See sections Clean needle and fill port on page C-8 and Cleaning the drip tray and wash plate
on page C-17!
Touch screen
Tubing paths
Recommended decontaminant
Surfaces
Tubing paths
Daily
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:
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 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!
The printer paper is heat sensitive on one side only. Please make sure that you insert the
paper roll correctly.
Weekly
h [More functions] > [System] > [Wash and clean] > [Decont. sample port
module]
t
Figure C-2
2 Open the flap to the labelled capillary position (completely open position).
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).
Figure C-3
Semi annual
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.
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.
e See Chapter 6 Quality control!
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.
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
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.
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
Figure C-7
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!
Remove the sticker from the empty bottle of C1 solution (see Figure C-11).
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
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.
5 Close the bottle compartment cover.
The fill port holder is part of the sample port module and should be exchanged every
3000 measurements.
h [More functions] > [System] > [Wash and clean] > [Decont. sample port
module]
1 Open the flap to the labelled capillary position (completely open position).
2 Rotate the fill port holder in the direction of the arrow (see the marking on the fill
port holder). It will come out of the axis and snap out of place (see
Figure C-12/1).
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
Figure C-14
Dispose of the used fill port holder in accordance with local regulations (hazardous
waste!).
Unscheduled
1 Open the bottle compartment cover. The bottle exchange image appears on the
display.
e See Figure C-7 on page C-12!
h [More functions] > [System] > [Tools] > [Fluid actions] > [Auto preparation
routines]
Select successively "Prepare Calibration Solution C1" and "Prepare Calibration
Solution C2".
The drip tray and the wash plate are parts of the sample port module.
h [More functions] > [System] > [Wash and clean] > [Decont. sample port
module]
Figure C-15
1 Open the flap to the labelled capillary position (completely open position).
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.
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.
10 Close the bottle compartment cover.
The printer paper is heat sensitive on one side only. Please make sure that you insert the
paper roll correctly.
A printer lever
Figure C-17
Figure C-18
Figure C-19
A B B
Figure C-20
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)
Figure C-21
Figure C-22
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".
Figure C-23
A B
A locking lever
B reference electrode
Figure C-24
A A
A white plug
Figure C-25
Figure C-26
If the tube does not lie precisely inside the guides, it may become pinched and thereby
prevent aspiration of the reference solution, resulting in calibration and measurement
errors.
7 Affix the white plug at the end of the reference electrode tube (see Figure C-25).
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.
Removing obstructions
First determine whether the electrodes have any obstructions and replace them, if
necessary.
Figure C-27
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.
h [More functions] > [System] > [Wash & clean] > [Automatic routines]
13 Then call up a system calibration.
Press:
h [More functions] > [System] > [Wash & clean] > [Decontaminate all tubes]
Follow the instructions on the screen.
1 Open the bottle compartment cover and remove bottles C1, C2, C3.
2 Fill the shutdown kit about halfway with Deproteinizer.
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
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).
Remove the remaining fluid from the tubes by briefly holding the tubes vertically, allowing
the fluid to run back into the container.
For cleaning excessive contamination in the bypass, press the following buttons:
h [More functions] > [System] > [Wash & cleaning] > [Decontaminate all tubes]
Follow the instructions on the screen.
e For an exact description of the procedure, see Decontaminate the tubing paths on
page C-26!
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
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).
Figure C-31
After leaving the window, the new correction values take effect.
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
Maintenance overview
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.
Maintenance scheduler
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
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.
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 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
For example:
Figure D-1
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.
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
Cause o Fundamental software functions can not be performed (memory problems, file
system problems), the correct operation of the instrument can not be guaranteed
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")
o In case of recurrence, call technical support.
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
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)
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
Cause o The pump calibration (rotational speed adjustment of the pump) failed
Cause o The sample detection with sample sensors (SS1 and SS2) failed
o The sample sensor board is defective
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 In case of recurrence, call technical support.
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
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!
Cause o The data access onto objects in the analyzer area failed, the correct operation of
the instrument can not be guaranteed
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
Figure D-5
e An exact description of this function can be found in the Reference Manual, chapter
System, section Tools > Diagnostics!
Sensor status
Figure D-6
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
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
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+
Cl Na K Ca PCO2 PO2 pH tHb SO2
AUTO-TROL TS+. Level 1 O O O O O O O O O
03321223001 (BP9106)
AUTO-TROL TS+. Level 2 O O O O O O O O O
03321231001 (BP9107)
AUTO-TROL TS+. Level 3 O O O O O O O O O
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
Accessories
Parameter
- + + 2+
Cl Na K Ca PCO2 PO2 pH tHb SO2
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!
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