Cobas B 123 POC System: Instructions For Use, Version 13.0 Software Version 4.17

cobas b 123 POC system
Instructions for Use, Version 13.0

Software version 4.17
Publication information
Revision history Manual Version Software Version Revision date Changes

1.0 November 2009 not delivered
2.0 2.0 November 2010 Launch
2.1 April 2011 FDA submission draft
3.0 2.3 August 2011
4.0  2.4 December 2011
5.0  3.0 July 2012
6.0 4.0 December 2012 internal release - not launched
7.0  4.0 January 2013
8.0 4.1 July 2013
9.0 ≥ 4.5 April 2014
10.0 ≥ 4.7 February 2015
10.1 ≥ 4.8 September 2016 Software update
11.0 ≥ 4.13 October 2017 Software update
12.0 ≥ 4.15 February 2019 o Safety messages update
o Data protection (GDPR)
update
o Software updates
13.0 ≥ 4.17 August 2020 o Hardware update
o Safety message updates
o Added hypodermic needle as
consumable
Table 1 Revision history
Edition notice This publication is intended for operators of the cobas b 123 POC system.
Every effort has been made to ensure that all information contained in this
publication is correct at the time of publishing. However, Roche may need to update
the publication information as output of product surveillance activities, leading to a
new version of this publication.
General attention
To avoid serious or fatal injury, ensure that you are familiar with the system and safety
information before you use the system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not described in this publication.
r Store all publications in a safe and easily retrievable place.
Training Do not carry out operation tasks or maintenance actions unless you or your trainer
have received training from a Roche representative. Leave tasks that are not described
in the user documentation to trained Roche Service representatives.
Screenshots The screenshots in this publication have been added exclusively for illustration
purposes. Configurable and variable data, such as tests, results, or path names visible
therein must not be used for laboratory purposes.
Roche Diagnostics
2 Instructions for Use · Version 13.0
Warranty Any customer modification to the system renders the warranty or service agreement
null and void.
For conditions of warranty, contact your local sales representative or refer to your
warranty contract partner.
Copyright © 2009-2020, F. Hoffmann-La Roche Ltd. All rights reserved.
License information cobas b 123 POC system software is protected by contract, copyright law and
international treaties. cobas b 123 POC system contains a user license between F.
Hoffmann-La Roche Ltd. and a license holder, and only authorized users may access
the software and use it. Unauthorized use and distribution may result in civil and
criminal penalties.
Open Source and Commercial cobas b 123 POC system may include components or modules of commercial or
Software open-source software. For further information on the intellectual property and other
warnings, as well as licenses pertaining to the software programs included in the
cobas b 123 POC system, refer to the electronic distribution included with this
product.
This open source and commercial software and the cobas b 123 POC system as a
whole can constitute a device regulated in accordance with applicable law. For more
detailed information, refer to the Instructions for Use and labeling.
Please note that the respective authorization is no longer valid according to the
corresponding legislation should any unauthorized changes be made to the
cobas b 123 POC system.
Trademarks The following trademarks are acknowledged: COBAS, COBAS B, LIFE NEEDS
ANSWERS, AUTOQC, ROCHE MICROSAMPLER and COMBITROL are
trademarks of Roche.
All other trademarks are the property of their respective owners.
Feedback Every effort has been made to ensure that this publication fulfills the intended use. All
feedback on any aspect of this publication is welcome and is considered during
updates. Contact your Roche representative, should you have any such feedback.
Approvals The cobas b 123 POC system meets the requirements laid down in:
Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices.
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011
on the restriction of the use of certain hazardous substances in electrical and
electronic equipment.
This instrument complies with the emission and immunity requirements described
in this part of the IEC 61326 series.
Compliance is provided by means of the Declaration of Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU directives.
Roche Diagnostics
Instructions for Use · Version 13.0 3
Issued by TÜV SÜD for Canada and the US.
Laboratory Equipment is the product identifier as shown on the

name plate.
Contact addresses
Manufacturer Roche Diagnostics GmbH

Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
www.roche.com
Edition
Version 13.0, August 2020

First edition: November 2009
Roche Diagnostics
Table of contents
Publication information 2 Operation

Contact addresses 4
Edition 4
5 Installation and put out of operation
Table of contents 5
Installation 129
Intended use 7
Installing the instrument 131
Intended user 7
Put out of operation 134
Use environment 7
Symbols and abbreviations 7
6 Measurement
What is new in this version 12
Preanalytics 139
Interferences 145
Introduction and specifications Limitations of clinical analysis 152
Configuring measurement input values 154
Configuring the measurement results screen 156
1 Safety information
Configuring the parameter selection field 157
Safety classifications 17
Performing a measurement 160
Safety precautions 18
Measurement modes 169
Safety labels on the instrument and
Entering measurement input values 170
consumables 26
Measurement results and reports 173
Measuring database 175
2 General description
Acid base maps 176
System information 29
Patient trend diagrams 177
System components 31
Consumable information 41
7 Quality control
General QC concept 181
3 Specifications
Important information for evaluating QC
Performance data 55
results 183
Sample throughput 79
Performing QC measurements 184
Sample measurement time 80
QC results and reports 191
Sample volumes 81
QC database 192
Sample types 82
Levey-Jennings graphs 193
Calibrations 83
Performing a proficiency test measurement 194
Environmental parameters 84
Configuring the QC scheduler 199
Product data 86
Defining and configuring QC materials 203
Printer 88
Configuring QC rules and consequences 207
User interface module 89
Configuring QC settings 209
Barcode scanner 90
Evaluating QC measurement results 211
Imaging scanner (optional) 92
Multirules 212
Removing QC consequences 215
4 Theoretical foundations
QC troubleshooting 218
Assigning unit formats to parameters 95
Troubleshooting AutoQC module blockages 219
Selecting between pH and H+ unit formats 96
Parameters and calculations 97
8 Calibration
Calibration principle 113
General information 223
Oximeter module (optional) 114
Automatic calibrations 225
Reference and critical values 115
User-activated calibrations 228
Assigning reference and critical ranges 118
Calibration database 229
Monitoring reference and critical ranges on
Configuring calibration settings 230
measurement reports 121
Assigning a correlation factor to a parameter 122
Roche Diagnostics
9 Calibration verification control Appendix

Installing AutoCVC Packs 236
13 Available accessories and consumables
Performing an AutoCVC measurement 238
Available accessories and consumables 335
Managing CVC results in the QC database 240
Configuring analytical measurement ranges 241
14 Copyright information
Software license information 341
10 Software functions
General software information 247
15 Glossary
Overview tab 251
Description of the screen areas 252
Workplace tab 255 Index
Instrument tab 256
Index 349
Utilities tab 257
Instrument databases 258
Logging on and off 260
Connecting USB storage devices 261
Configuring system settings 262
Configuring network connection settings 269
Configuring operator settings 278
Changing security levels 282
Performing software and language updates 284
Exporting and importing configuration
settings 285
Audit trail 286
Available printout reports 288
Consumable change
11 Consumable change
Disinfection procedures 299
Disinfecting the instrument 301
Changing consumables 303
Additional information for consumable
changes 307
Troubleshooting
12 Troubleshooting
Alarm area and buttons 314
System stops 316
Defects 320
Warnings 321
Information alarms 322
Status messages on the measurement report 323
Calibration and QC troubleshooting for
parameters 324
Performing Sensor Cartridge wetting routines 326
Checking the Fluid Pack valve positions 327
Barcode scanner troubleshooting 328
Creating troubleshooting reports and log files 329
Depot repair 330
Roche Diagnostics
Intended use
The cobas b 123 POC system is a fully automated POC system for in vitro
measurement of pH, blood gases (BG), electrolytes (ISE), hematocrit (Hct),
metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb,
HHb, COHb, MetHb), oxygen saturation (SO2) and neonatal bilirubin (Bili).
In addition, the cobas b 123 POC system calculates derived parameters.
It is dedicated for use in a Point-of-Care environment and laboratory.
The integrated AutoQC module and the oximeter module are available as an option.
Intended user
Users of the cobas b 123 POC system are trained professionals in the laboratory and
trained healthcare professionals in a point-of-care environment.
Use environment
The cobas b 123 POC system is intended to be operated in point-of-care settings and
hospital laboratories.
Symbols and abbreviations
Product names Except where the context clearly indicates otherwise, the following product names
and abbreviations are used.
Product name Descriptor

cobas b 123 POC system system
cobas b 123 Fluid Pack Fluid Pack
cobas b 123 Sensor Cartridge Sensor Cartridge
cobas b 123 AutoQC Pack AutoQC Pack
cobas b 123 AutoCVC Pack AutoCVC Pack
cobas b 123 Printer Paper printer paper
Table 2 Product names
Symbols used in the publication Symbol Explanation

o List item
r Start of a task
s End of a task
u Related topics containing further information
q Tip. Extra information on correct use or useful hints.
Table 3 Symbols used in the publication
Roche Diagnostics
Symbols used on the instrument Symbol Description
Catalog number
Serial number
Global Trade Item Number
Manufacturer
Date of manufacture
Direct current
Caution
Biohazard
Table 4 Symbols used on the instrument
Symbols used on consumables Symbol Description
Catalog number
Batch code
Global Trade Item Number
Use by date
Temperature limitation
Table 5 Symbols used on consumables
Roche Diagnostics
Symbol Description
Do not use if package is damaged
Consumable contents
Control material
Fragile handle with care
Store upright
Do not reuse
Manufacturer
Sterilized using irradiation
Sterilized using ethylene oxide
Sufficient for <n> tests
Operator’s manual/operating instructions
Caution, consult accompanying documents
Handle with care
Software symbol for the Fluid Pack
Roche Diagnostics
Symbol Description
Software symbol for the AutoQC Pack
Software symbol for the Sensor Cartridge
Biohazard
Abbreviations Abbreviation Definition

1P 1-point calibration
2P 2-point calibration
AMR Analytical measurement range
Arate Assisted breathing rate
ASTM American Society for Testing and Material
AutoQC Automatic Quality Control
BG Blood gas
Bili Bilirubin
BSA Bovine serum albumin
Ca2+ Ionized calcium
CCD Charge coupled device
CE Conformité Européenne
CF Compact flash
Cl- Chloride
CLIA Clinical Laboratory Improvement Amendments
CLSI Clinical and Laboratory Standards Institute
COHb Carboxyhemoglobin
COOX Co-oximetry
CPAP Continuous positive airway pressure
CSV Comma-separated values
CVC Calibration verification control
DHCP Dynamic host configuration protocol
DIN German national organization for standardization
DNS Domain name server
e.g. for example
EC European community
EN European standard
EQA External Quality Assurance
Glu Glucose
H + Hydrogen ion concentration
Hb Hemoglobin
Hct Hematocrit
Table 6 Abbreviations
Roche Diagnostics
Abbreviation Definition
HHb Deoxyhemoglobin
i.e. that is to say
IEC International Electrotechnical Commission
ISE Ion-selective electrode
ISO International Organization for Standardization
IT Information technology
IVD In vitro diagnostic
K + Potassium
Lac Lactate
LCD Liquid crystal display
LED Light-emitting diode
LIS Laboratory Information System
MAP Mean airway pressure
MCHC Mean corpuscular hemoglobin concentration
MCT Medium chain triglycerides
MetHb Methemoglobin
mm millimeter
MSDS Material safety data sheet
MV Mean value
Na+ Sodium
NIST National Institute of Standards and Technology
O2Hb Oxyhemoglobin
PCO2 Partial pressure of carbon dioxide
PEEP Positive end-expiratory pressure
PIP Peak inspiratory pressure
PO2 Partial pressure of oxygen
POC Point-of-care
POCT1-A Connectivity standard for point of care devices
QC Quality control
RAM Random access memory
RECAL Recalibration
RQ Respiratory quotient
SD Standard deviation
SD card Secure digital memory card
SIM Sample input module
SO2 Oxygen saturation
Srate Spontaneous breathing rate
STDBY Standby
Te Expiratory time
tHb Total hemoglobin
Ti Inspiratory time
Roche Diagnostics
Abbreviation Definition
UIM User interface module
USB Universal Serial Bus
VT Tidal volume
What is new in this version
o Updates for new hardware version

o Updated safety messages
o Added Hypodermic needle as consumable
o Editorial updates.
Roche Diagnostics
Introduction and specifications
1 Safety information ........................................................................................................................... 15

2 General description .......................................................................................................................... 27
3 Specifications .................................................................................................................................... 51
4 Theoretical foundations ................................................................................................................... 93
cobas b 123 POC system 1 Safety information
Table of contents
Safety information 1
The chapter provides information about the safe operation of the system.
In this chapter Chapter 1

Safety classifications.............................................................................................................17
Safety precautions.................................................................................................................18
Operator qualification ...................................................................................................18
Safe and proper use of the system................................................................................18
Installation and deinstallation ......................................................................................19
Operating conditions.....................................................................................................19
Electrical safety...............................................................................................................20
Biohazardous materials .................................................................................................20
Mechanical safety ...........................................................................................................21
Consumables...................................................................................................................21
Reagents and working solutions...................................................................................22
Incorrect results..............................................................................................................23
Software and data security ............................................................................................24
Instrument damage........................................................................................................25
Safety labels on the instrument and consumables ...........................................................26
Roche Diagnostics
1 Safety information cobas b 123 POC system
Table of contents
Roche Diagnostics
Safety classifications
Safety classifications
This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the ANSI
Z535.6 Standard. Familiarize yourself with the following meanings and icons:
Safety alert
The safety alert symbol is used to alert you to potential physical injury hazards. Obey all
safety messages that follow this symbol to avoid possible damage to the system, injury, or
death.
These symbols and signal words are used for specific hazards:
WARNING
r ... indicates a hazardous situation that, if not avoided, could result in death or serious
WARNING injury.
CAUTION
r ... indicates a hazardous situation that, if not avoided, could result in minor or moderate
CAUTION injury.
NOTICE NOTICE
r ... indicates a hazardous situation that, if not avoided, may result in damage to the
instrument.
Protective gloves and goggles, suitable protective clothing, and if necessary, mouth
protection has to be worn.
Important information that is not safety relevant is indicated with the following
symbol:
q Tip
... indicates additional information on correct use or useful tips.
Roche Diagnostics
Safety precautions
Safety precautions
To avoid serious or fatal injury, read and comply with the following safety
precautions.
CAUTION
Operator qualification
Insufficient knowledge and skills As an operator, ensure that you know the relevant safety precaution guidelines and
standards and the information and procedures contained in these instructions.
o Do not carry out operation and maintenance unless a Roche representative has
trained you or your trainer to do so.
o Leave maintenance, installation, or service that is not described to trained Roche
Service representatives.
o Carefully follow the procedures specified in the instructions for operation and
maintenance.
o Follow standard laboratory practices, especially when you work with
biohazardous material.
Safe and proper use of the system
Personal injury and infection due to sharps, rough edges, and/or moving parts
r Good Laboratory Practice can reduce the risk of injury. Be aware of your laboratory
WARNING environment, well-prepared, and follow the instructions for use. Some areas of the
instrument may have sharps, rough edges, and/or moving parts. Wear personal
protective equipment to minimize the risk of injury from bodily contact with such parts,
especially in less accessible areas, or while cleaning the instrument. Your personal
protective equipment should be appropriate to the degree and type of potential hazard,
e.g. suitable lab gloves, eye protection, lab coat, and footwear.
Missing personal protective equipment

Working without personal protective equipment means danger to life or health. Using the
WARNING instrument in a way that is not described by the manufacturer can impair the protection
provided.
r Wear appropriate personal protective equipment, such as:
o Lab gloves
o Lab coat
o Eye protection
o Face shield if there is a chance of splashing or splattering
System not used for an extended o If the system will not be used for more than 24 hours, put the system out of
period operation.
o Remove and refrigerate any remaining reagents.
o For further information, call your Roche Service representative.
Non-approved parts Use of non-approved parts or devices may result in malfunction of the system and
may render the warranty null and void.
o Use only parts and devices approved by Roche Diagnostics.
Roche Diagnostics
Safety precautions
Installation and deinstallation
Transport Risk of personal injury when lifting. The cobas b 123 POC system, without
consumables in the bottle compartment and AutoQC materials in the AutoQC
module, weighs approximately 20 kg.
o Perform the put out of operation procedure before moving the system.
u Put out of operation (p. 134)
o Do not attempt to relocate or transport the system without the assistance of
another individual.
o Do not attempt to lift the system with a Fluid Pack and AutoQC Pack in the
system. In addition, make sure that before lifting, there are no other objects
attached to the system.
o Lift the system only from its designated holding points.
u Holding points (p. 87)
Errors in installation Only trained Roche Service representatives may install the system.
o Leave installation that is not described to trained Roche Service representatives.
Disposal A biohazardous system may lead to infection.

o Treat the system as biohazardous waste. Decontamination (the combination of
processes including cleaning, disinfection, and/or sterilization) is required before
reuse, recycling, or disposal of the system.
o Dispose of the system according to the local regulations. For more information,
contact your Roche service representative.
Operating conditions
NOTICE Unsuitable operating conditions

Operation outside of the specified ranges may lead to incorrect results or malfunction of
the system.
r Use the system indoors only, and avoid heat and humidity outside of the specified
range.
r Make sure that the system’s ventilation openings always remain unobstructed.
r Keep the analyzer away from all sources of liquids, such as sinks and wash basins.
r Keep the operating instructions undamaged and available for use. Operating
instructions have to be easily accessible for all users.
Electromagnetic interference Strong electromagnetic fields (originating from unshielded radio-frequency sources)
can interfere with proper operation and may lead to malfunction of the system and
incorrect results.
o Do not use this system near sources of strong electromagnetic fields because these
fields can interfere with its proper operation.
o Evaluate the electromagnetic environment before you operate the system.
o Take measures to mitigate the interference.
Roche Diagnostics
Safety precautions
Electrical safety
Electrical shock
Removing the covers of electronic equipment can cause electric shock because there are
CAUTION high-voltage parts inside.
r Do not attempt to work in any electronic equipment.
r Do not remove any cover of the system except those covers specified in the
instructions.
r Only Roche Service representatives may install, service, and repair the system
Electrical specifications Comply with the following electrical specifications when operating the
cobas b 123 POC system:
o The power cable has to be connected into a grounded power socket. If you
connect the instrument to an extension cable, the extension cable has to be
connected into a grounded power socket.
o The power cable has to conform to country-specific requirements. Contact your
Roche Service representative for more information.
o Only use electrical accessories, such as power cables, provided by Roche. Do not
alter any electrical equipment on the instrument, or any electrical accessories that
accompany the system.
Biohazardous materials
Infectious samples Contact with samples containing material of human origin may result in infection.
All materials and mechanical components associated with samples containing
material of human origin are potentially biohazardous.
o Follow standard laboratory practices, especially when working with biohazardous
material.
o Keep all covers closed while the system is operating.
o Follow the instructions in this manual when performing procedures with the top
cover of the system removed.
o Wear appropriate personal protective equipment.
o If any biohazardous material is spilled, wipe it up immediately and apply a
disinfectant.
o If sample or waste comes into contact with your skin, wash the affected area
immediately with soap and water and apply a disinfectant. Consult a physician.
Sharp objects Contact with probes or needles may result in infection.

o When you wipe probes or needles, use several layers of gauze and wipe from the
top down.
o Take care not to puncture yourself.
o Wear appropriate personal protective equipment. Take extra care when working
with lab gloves, which can easily be pierced or cut, leading to infection.
Roche Diagnostics
Safety precautions
Infectious waste Contact with waste (liquid and/or solid) may result in infection. All materials and
mechanical components associated with the waste systems are potentially
biohazardous.
o Wear appropriate personal protective equipment. Take extra care when working
with lab gloves. They can be easily pierced or cut, leading to infection.
o If any biohazardous material is spilled, wipe it up immediately and apply a
disinfectant.
o If waste comes into contact with your skin, wash the affected area immediately
with soap and water and apply a disinfectant. Consult a physician.
Environmental harm The system generates liquid and/or solid waste. This waste contains concentrated
reaction solutions and is potentially biohazardous. Improper disposal may
contaminate the environment.
o Treat this waste as infectious waste.
o Dispose of waste in accordance with the local regulations.
Mechanical safety
Opening and closing the instrument’s door

Opening and closing the instrument’s door may result in personal injury to your hands.
CAUTION r Always open and close the door with both hands.
r When opening and closing the door, do not hold other objects.
Consumables
Incorrect handling of consumables

Incorrect handling of the consumables may result in infection, and errors in diagnosis, both
WARNING posing danger to the patient.
r Always handle consumables correctly. The Fluid Pack has to be carried by its handle in
an upright position.
r Do not use consumables that have exceeded their expiry dates. The expiry date of
consumables is shown on its packaging.
r When handling used consumables, observe relevant laboratory procedures on safe
usage. Wear appropriate personal protective equipment, such as:
o Lab gloves
o Lab coat
o Eye protection
r Dispose of consumables according to the local regulations. For more information,
contact your Roche service representative
Handling QC material and AutoCVC packs

r QC material and AutoCVC packs must have adjusted to room temperature for at least
WARNING 24 hours before performing a measurement.
Roche Diagnostics
Safety precautions
NOTICE Inserting damaged consumables

Inserting damaged consumables may result in damage to the system.
r Check for possible damage to the Fluid Pack, AutoQC Pack and AutoCVC Pack during
transportation. If it shows evidence of damage, do not insert it into the system.
Incorrect storage Incorrect storage of the consumables may lead to errors in diagnosis, posing danger
to the patient.
o Always store consumables according to the specified storage conditions as stated
in the Instructions for Use.
u Environmental parameters (p. 84)
o Acclimatize the Fluid Pack, AutoQC Pack and AutoCVC Pack to ambient
temperature before installing it in the system.
Disinfection Trace amounts of hazardous liquids may be found in the consumables area. Direct
contact with hazardous liquids may lead to biohazardous contamination, resulting in
infection.
o Regularly disinfect the consumables area with disinfectant. Follow standard
laboratory practices.
Reagents and working solutions
Skin inflammation or injury

Direct contact with reagents, detergents, cleaning solutions, or other working solutions
CAUTION may cause skin irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions required for handling laboratory
reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the package insert.
r Observe the information given in Material Safety Data Sheets (available for Roche
Diagnostics reagents and cleaning solutions).
r If reagents, detergents, or other cleaning solutions come into contact with your skin,
wash the affected area immediately with soap and water and apply a disinfectant.
Consult a physician.
Fire and burns Alcohol is a flammable substance.

o Keep all sources of ignition (such as sparks, flames, or heat) away from the system
when you perform maintenance or checks that involve alcohol.
o When you use alcohol on or around the system, use no more than 20 mL at a
time.
Roche Diagnostics
Safety precautions
Incorrect results
Poor accuracy and precision Incorrect results may lead to errors in diagnosis, posing danger to the patient.
o For the proper use of the system, run QC tests and monitor the system during
operation.
o Do not use reagents or consumables that have exceeded their expiry date,
otherwise you may obtain inaccurate data. Do not use damaged Fluid Packs.
o For diagnostic purposes, always assess the results with the patient’s medical
history, clinical examination, and results from other consultations.
Incorrect reagent volume Incorrect reagent handling may cause an undetectable loss of reagent.
o Always store reagents according to the specified storage conditions as stated in
the package insert or the Instructions for Use.
Foam, clots, films, or bubbles Incorrect results may occur due to foam, fibrin clots, films, or bubbles in reagents or
samples.
o Avoid the formation of foam, clots, and bubbles in all reagents, samples,
calibrators, and controls.
Evaporation of samples or Evaporation of samples or reagents may lead to incorrect or invalid results.
reagents
o Sample material may evaporate if left open. Do not leave samples open for any
length of time.
o Do not use improperly stored reagents. Ensure that reagents are stored according
to the package insert or the Instructions for Use.
Roche Diagnostics
Safety precautions
Software and data security
Unauthorized system access and data loss

Malicious software or unauthorized system access can result in data loss or system
WARNING unavailability. External storage devices can transmit computer malware, which may be
used to gain unauthorized access to data or cause unwanted changes to software.
The operators are responsible for the IT security of their IT infrastructure and for protecting
it against malicious software and hacker attacks.
Users of the instrument should be trained on appropriate handling, including data privacy
and cybersecurity, of the instrument.
r To avoid infection by malicious software or the unauthorized access and misuse of the
system, Roche recommends the following precautions:
o Connect the system to safe, closed networks only.
o Make sure other computer and services on the network (e.g., the LIS, archiving
share, backup share, or service) are properly secured and protected against
malicious software and unauthorized access.
o Ensure that attached networks are secure. Customers are responsible for the
security of their local network, especially in protecting it against malicious software
and attacks. This protection might include measures, such as a firewall, to separate
the device from uncontrolled networks as well as measures that ensure that the
connected network is free of malicious code.
o Restrict physical access to the system and all attached IT infrastructure (computer,
cables, network equipment, etc.).
o Allow connection only to authorized external devices.
o To protect all external devices, make sure that you use appropriate security
software.
o To protect access to all external devices, make sure that you use appropriate
security equipment. Your Roche Service representative can recommend a suitable
firewall.
o Do not copy or install any software on the system unless it is part of the system or
your Roche Service representative tells you to do so.
o If extra software is required, contact your Roche Service representative to ensure
validation of the software in question.
o Do not use the USB ports to connect other storage devices unless your Roche
Service representative or an operating instruction tells you to do so.
o Exercise care when you use external storage devices such as USB drives. Do not
connect to the system any external storage device that you use on public or home
computers.
o Back up your data regularly. Make sure that system backup and archive files are
physically secured and are protected from any unauthorized access and disaster.
This includes remote storage location, disaster recovery sites and secure transfer of
backup files.
o Update to latest software versions for the specified system configuration provided
by Roche as soon as possible.
o Only data required for its purpose shall be entered on a Roche device. Avoid use of
direct identifiers with sensitive data or free-text fields.
o Request from Roche service the deletion of data on a regular basis, if direct
identifiers are to be processed by the instrument.
o Enable encryption on network communication.
Roche Diagnostics
Safety precautions
Corrupt data due to a disclosed The security of the system and its data depends on the password-protected access. If
password an unauthorized person discovers your user ID and password, they could
compromise this security.
o Create a separate user account for each operator with appropriate operator level.
o Use strong passwords.
o Always enter your password unobserved.
o Do not write down your password anywhere, including in a contact form, in the
address book, or in a file on the computer.
o Do not disclose your password to anyone. Roche never asks you for your
password.
o If you ever disclose your password to anyone, change it immediately afterwards.
o Do not share user accounts.
o Contact your local Roche affiliate if you think your account has been
compromised.
o Remove the credentials of employees who have left the company.
Non-approved third-party Installation of any third-party software that is not approved by Roche Diagnostics
software may result in incorrect behavior by the system.
o Install only Roche approved third-party software.
Unreliable validation due to Roche shall not be held liable for any consequences resulting from subsequent,
unauthorized changes to the unauthorized modifications to the accepted validation settings included in the system
validation settings at the customer’s request.
o Ensure that only authorized personnel can change, if necessary, the validation
settings.
Unreliable validation due to Roche shall not be held liable for any consequences resulting from subsequent,
unauthorized changes to the unauthorized modifications to the accepted validation and calculation rules included
validation and calculation rules in the system at the customer’s request, as well as test results.
o Ensure that only authorized personnel can change, if necessary, the validation and
calculation rules, and test results.
Instrument damage
NOTICE Circuit breakers and fuses

Improper use may result in damage to the system.
r If one of the circuit breakers or fuses blow, do not attempt to operate the system before
contacting your Roche Service representative.
Spilled liquid Any liquid spilled on the system may result in malfunction or damage.
o Place samples, reagents, or any other liquid only at the intended positions. Do not
place samples, reagents, or any other liquid on the covers or other surfaces of the
system.
o When you remove or replace consumables, do not spill any liquid on the system.
o If liquid does spill on the system, wipe it up immediately and apply a disinfectant.
Wear appropriate personal protective equipment. Dispose waste according to the
local regulations.
Roche Diagnostics
Safety labels on the instrument and consumables
Safety labels on the instrument and consumables
The instrument and its consumables have warning labels to draw your attention to
areas of potential hazard.
The safety labels on the system comply with the following standards: ANSI Z535, IEC
61010-2-101, IEC 61010-1, IEC 60417, ISO 7000, or ISO 15223-1.
q Only Roche Service representatives may replace damaged labels. For replacement labels,
contact your Roche Service representative.
Safety labels on the instrument Biohazard

Potentially biohazardous materials are used near this label.
Observe relevant laboratory procedures on safe usage.
Safety labels on consumables Biohazard

Fluid Packs, AutoQC Packs, AutoCVC Packs, and Sensor Cartridges
contain potentially biohazardous materials.
When handling Fluid Packs, AutoQC Packs, AutoCVC Packs, and
Sensor Cartridges, observe relevant laboratory procedures on safe
usage. Wear appropriate personal protective equipment, such as:
o Lab gloves
o Lab coat
o Eye protection
Roche Diagnostics
cobas b 123 POC system 2 General description
Table of contents
General description 2
This chapter contains a general description of the system, and detailed descriptions of
its individual modules and consumables.

System information..............................................................................................................29
Accessory information ..................................................................................................30
System components..............................................................................................................31
Visual identification.......................................................................................................31
Printer..............................................................................................................................32
Front door .......................................................................................................................32
Measuring chamber module.........................................................................................32
Rear panel........................................................................................................................33
Interfaces: Hardware version 1.....................................................................................35
Interfaces: Hardware version 2.....................................................................................37
Barcode scanner .............................................................................................................38
Imaging scanner (optional) ..........................................................................................39
User interface module ...................................................................................................40
Consumable information ....................................................................................................41
Sensor Cartridge.............................................................................................................41
Sensor phases............................................................................................................42
BG sensors ................................................................................................................43
ISE sensors ................................................................................................................44
Glu/Lac sensors ........................................................................................................45
Fluid Pack........................................................................................................................46
cobas b 123 AutoQC Pack (optional)..........................................................................49
Roche Diagnostics
2 General description cobas b 123 POC system
Table of contents
Roche Diagnostics
System information
System information
Figure 2-1 cobas b 123 POC system
The cobas b 123 POC system is a fully automated POC system for in vitro
measurement of pH, blood gases (BG), electrolytes (ISE), hematocrit (Hct),
metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb,
HHb, COHb, MetHb), oxygen saturation (SO2) and neonatal bilirubin (Bili).(1)
In addition, the system determines calculated values.
It is intended for use in POC and laboratory environments. Integrated AutoQC and
oximeter modules are available as optional features.
The following parameters are available to be measured by the system in human whole
blood, dialysis solutions, and QC materials. This list depends on your system’s
variant, and the type of Sensor Cartridge and Fluid Pack you use.
Instrument variants Measured parameters

Instrument variant Optional modules
cobas b 123 <1> POC system pH, BG (PO2, PCO2 ), ISE (Na+, K+, Cl–, Ca2+), Hct, Glu, Lac
Table 2-1 Instrument variants
(1) total bilirubin
Roche Diagnostics
System information
Instrument variant Measured parameters Optional modules

cobas b 123 <2> POC system pH, BG (PO2, PCO2 ), ISE (Na+, K+, Cl–, Ca2+), Hct, Glu, Lac AutoQC module
cobas b 123 <3> POC system pH, BG (PO2, PCO2), ISE (Na+, K+, Cl–, Ca2+), Hct, Glu, Lac, Oximeter module
tHb, O2Hb, HHb, COHb, MetHb, SO2, Bili
cobas b 123 <4> POC system pH, BG (PO2, PCO2), ISE (Na+, K+, Cl–, Ca2+), Hct, Glu, Lac, AutoQC & Oximeter
tHb, O2Hb, HHb, COHb, MetHb, SO2, Bili module
Table 2-1 Instrument variants
Sample type Sample types Measured parameters

Whole blood, QC material pH, BG (PO2, PCO2), ISE (Na+, K+, Cl–, Ca2+), Hct, Glu, Lac, tHb, O2Hb, HHb, COHb,
MetHb, SO2, Bili
Dialysis solution Na+, K+, Ca2+
Table 2-2 Sample types
Hardware versions
u User interface module (p. 89)
Hardware version Instrument variant Serial numbers

Version 1 cobas b 123 <1> POC system 16'000 and below
cobas b 123 <2> POC system 21'000 and below
Version 2 cobas b 123 <1> POC system 16'001 and above
cobas b 123 <2> POC system 21'001 and above
Table 2-3 Hardware versions
Accessory information
The following accessories are delivered as standard equipment with the

cobas b 123 POC system:
o 1 barcode scanner
o 1 power supply
o 1 USB flash drive
o 1 roll printer paper
Roche Diagnostics
System components
System components
Visual identification
C
F
D
H
A Printer (part of the user interface module) E Screen (part of the user interface module)
B USB port F Sample input module (part of the Fluid Pack)
C Measuring chamber module with Sensor Cartridge G Fluid Pack
D AutoQC module with AutoQC Pack H Front door
Figure 2-2 cobas b 123 POC system
Roche Diagnostics
System components
Printer
Figure 2-3 Thermal printer
The thermal printer is a part of the user interface module.
Paper feed button on the printer
Front door
The measuring chamber module with the Sensor Cartridge, the Fluid Pack with the
sample input module, and the AutoQC module with the AutoQC Pack (optional) are
located behind the front door.
Measuring chamber module
The measuring chamber module is located behind the front door.
q Make sure that the green area of the measuring chamber is visible before removing the
Sensor Cartridge from the measuring chamber module.
The measuring chamber has a red and a green area. When you see the red area, the
Sensor Cartridge cannot be removed from the measuring chamber module. When
you see the green area, the Sensor Cartridge can be removed.
A Position for replacement (green) B Position in normal operation (red)
Figure 2-4 Measuring chamber module

Roche Diagnostics
System components
Inappropriate handling of Sensor Cartridges may result in infection

Sensor Cartridges may contain trace amounts of hazardous liquids. Inappropriate handling
WARNING of Sensor Cartridges may lead to direct exposure of these liquids, which may lead to
serious skin burns, eye damage, and other serious health risks.
r When handling Sensor Cartridges, prevent direct contact by wearing appropriate
personal protective equipment, such as:
o Lab gloves
o Lab coat
o Eye protection
r When handling Sensor Cartridges, keep them upright, with the inlet and outlet of the
Sensor Cartridge pointed upwards, to avoid spillage.
r If any biohazardous material is spilled, wipe it up immediately and apply a disinfectant.
r If contents from the Sensor Cartridge come into contact with your skin, wash the
affected area immediately with soap and water and apply a disinfectant. Consult a
physician.
Rear panel
A D
B
A Power switch C Power supply

B Interfaces D Connection socket for power supply
Figure 2-5 Rear panel
Roche Diagnostics
System components
Button (on/off)
q Pressing the on/off button does not disconnect the instrument from the power supply.
To disconnect the instrument from the power supply, disconnect the power cable plug
from the mains socket.
A On/off button
Figure 2-6 On/off button: Hardware version 1
A On/off button: Hardware version2
Figure 2-7 On/off button: Hardware version 2
u Hardware versions (p. 30)
Power supply The power supply supplies the instrument with 12 V DC (10 A).
q Use the power supply in the horizontal position only.
Power cable
q The power cable has to conform to country-specific requirements. To place an order for a
power cable, contact your Roche Service representative.
The power cable has to meet these minimum specifications:
Supply Cable type Cable Rated Rated Min. Connector Connection(1) Additional
voltage cross- current voltage length requirements
Power supply
section
100-125 V(2) SVT, SJT, 3- 18 AWG 15 A 125 V 2 m (6 ft.) Molded; IEC320- Locally permitted
core locally EN60320/C13 (e.g. UL. CSA. JET.
permitted; CCC. etc.); suitable
hospital grade for medical use
230-240 V 3-core, PVC min. 10 A 300 V 2 m (6 ft.) Molded; IEC320- Locally permitted;
insulated 0.75 mm2 locally EN60320/C13 HAR mark on plug
(18 AWG) permitted or socket; suitable
for medical use
Roche Diagnostics
System components
(1) IEC320-EN60320/C13: Plugs and Socket-Outlets for Household and Similar Purposes
(2) Standard for the US, Canada, and Japan.
Name plate Refer to Symbols used on the instrument (p. 8) to find the meaning of the symbols
used on the name plate.
Interfaces: Hardware version 1
A B C D E F G H I
A USB ports F Equipotential bonding plug

B Barcode scanner G Button (on/off)
C External ticket printer (RS 232) H Status LEDs (2x) and fuses (2x) (Fuse 5A slow 250V)
D CompactFlash card I Power supply
E Network: Ethernet (RJ45)
Figure 2-8 Interfaces: Hardware version 1
o 2 USB ports
o Barcode scanner: PS/2 DIN - 6p female socket
o 1x RS 232 interface (e.g. external ticket printer)
o 1x CompactFlash card slot
o 1x 100BaseTX Ethernet (RJ45)
o 2x LED: control lamps for supply voltage
o 2x fuses: 5A slow blow 250 V
o Power supply: connection socket for external power supply
Each voltage supply circuit has a “Power ON” display (green LEDs next to the fuses).
The LEDs are wired into the circuit downstream of the fuses.
RS 232 interface assignment RS 232 interface connections may be used to establish connections with other
(Hardware version 1 only) devices, such as external ticket printers. 9-pin SUBMIN D is available for these
interface connections.
5 4 3 2 1
9 8 7 6
Figure 2-9 RS 232 interface assignments

Roche Diagnostics
System components
Pin 1 DCD Data carrier detected

Pin 2 RxD Receive data
Pin 3 TxD Transmit data
Pin 4 DTR Data terminal ready
Pin 5 GND Signal ground
Pin 6 DSR Data set ready
Pin 7 RTS Request to send
Pin 8 CTS Clear to send
Pin 9 RI Ring indicator
Barcode scanner assignments A PS/2 DIN-6p socket is used to connect the barcode scanner.
(Hardware version 1 only)
Figure 2-10 PS/2 DIN-6p socket assignments
Pin 1 PC data
Pin 2 NC
Pin 3 GND Signal ground
Pin 4 Vcc +5 V power supply
Pin 5 PC-CLK Clock
Pin 6 NC
Network interface assignments Ethernet plug standard (RJ-45) to establish four-core unshielded twisted pair (UTP)
Ethernet connections.
Figure 2-11 Ethernet socket assignments
USB port assignments USB is an industry standard used for connecting various peripheral devices (e.g.,
USB barcode scanner, USB ticket printer).
Figure 2-12 USB port assignments
Pin 1 VCC5
Pin 2 D-
Pin 3 D+
Pin 4 GND
Roche Diagnostics
System components
Interfaces: Hardware version 2
A A B C D E F
A 3x USB Ports for barcode scanner and ticket printer D Button (on/off)
B SD card E Status LEDs (2x) and fuses (2x) (Fuse 5A slow 250V)
C Network: Ethernet (RJ45) F Power supply
Figure 2-13 Interfaces: Hardware version 2
o 3x USB ports (for USB barcode scanner and external USB ticket printer)
o 1x SD card slot
o 1x 1000BaseT Ethernet (RJ45)
o 2x LED: control lamps for supply voltage
o 2x fuses: 5A slow blow 250 V
o Power supply: connection socket for external power supply
Each voltage supply circuit has a “Power ON” display (green LEDs next to the fuses).
The LEDs are wired into the circuit downstream of the fuses.
Network interface assignments Ethernet plug standard (RJ-45) to establish eight-core unshielded twisted pair (UTP)
Ethernet connections.
Figure 2-14 Ethernet socket assignments
USB port assignments USB is an industry standard used for connecting various peripheral devices.
Figure 2-15 USB port assignments
Roche Diagnostics
System components
Pin 1 VCC5
Pin 2 D-
Pin 3 D+
Pin 4 GND
Barcode scanner
Figure 2-16 Barcode scanner
The barcode scanner is used for easily scanning manual QC materials (lot number,
target values, etc.) and patient or user IDs.
u Barcode scanner (p. 90)
q You see a brief illumination of the LED light on the top of the barcode scanner when you
have successfully scanned in a barcode.
q If a manual, non-Roche QC material is used, reprogramming of barcode types “Code 39”

and “Interleaved 2 of 5” (without check digits) is not allowed. The corresponding data can
no longer be scanned.
If you use one of the 2 barcodes with check digits, contact your Roche Service
representative.
Barcode printing quality To assure optimal barcode scanning performance, it is required that sample barcodes
have a print quality of ISO/IEC 15416 grade 2.5 to 4.0 (corresponds to ANSI X3.182
grade A or B).
To further assure barcode scanning performance, follow these recommendations:
o The label or piece of paper with the printed barcode should be smooth and
unfolded.
o The printed barcode must not be distorted in the printing process. Make sure that
quality printing ink, ribbon and/or toner is used.
o Do not use special color ink and non-white paper or labels, as they can impact the
scanner function. For example, avoid the use of red ink or red paper, because the
light source of the barcode scanner is red.
o Do not use printing materials with shiny or reflective surfaces.
Roche Diagnostics
System components
q For more information, see the manufacturer’s Reference Guide. The Reference Guide is
available from your Roche representative.
Imaging scanner (optional)
Using the non-directional imaging scanner, you can scan patient and product
information into the system.
u Imaging scanner (optional) (p. 92)
q For more information, refer to the imaging scanner’s manual. The manual is available from
your Roche Service representative.
Figure 2-17 Imaging scanner
Roche Diagnostics
System components
User interface module
I
C
D
J
F
M
G N
A Status area H Consumable status area

B Menu tab I Logon button
C Next calibration message window J Cancel button
D Next AutoQC measurement message window K Print button
E Parameter selection field L Info button
F Start measurement buttons M Legend button
G Alarm area and button N Online help button
Figure 2-18 User interface
Screen The screen consists of a color touch screen.

All information (results, error messages, alarms, warnings, etc.) is displayed on the
screen.
NOTICE Using sharp objects may damage the screen

If you use a sharp object on the screen, the touch screen may be damaged.
r Only use your finger or a stylus pen to navigate the system’s user interface.
Roche Diagnostics
Consumable information
Sensor Cartridge
A B C D
A Sensor Cartridge handle D BG sensor part

B ISE sensor part E Smart memory chip
C Glu/Lac sensor part
Figure 2-19 Sensor Cartridge
Sensor Cartridge types cobas b 123 Sensor Cartridge BG, Hct(1)

cobas b 123 Sensor Cartridge BG, ISE, Hct(1)
cobas b 123 Sensor Cartridge BG, ISE, Hct, Glu(1)
cobas b 123 Sensor Cartridge BG, ISE, Hct, Glu, Lac(2)
(1) up to 700 tests or up to 28 days
(2) up to 500 tests or up to 21 days
u Sensor Cartridge types (p. 335)
Memory chip A memory chip is attached to the Sensor Cartridge to store and transmit data to the
instrument, and vice versa.
The following data is saved on the memory chip:
o Lot number o Installation date o Number of samples

o Expiration date o Sensor variant o Storage period outside of the instrument
Hold the Sensor Cartridge by its handle.
Roche Diagnostics
Sensor phases
Phase Instrument performance

START-UP phase No measuring operation
RUN-IN phase Measuring operation with longer time-to-display or time-to-
ready
Stable phase Regular operation
IN-USE time Sensor Cartridge in-use time
Table 2-4 Sensor phases
After inserting a new Sensor Cartridge, allow up to 60 minutes (typically) for the
cartridge to perform START-UP phase actions.
START-UP phase The START-UP phase begins when a new Sensor Cartridge is inserted into the
system. During the START-UP phase, the system performs actions on the
Sensor Cartridge to prepare it for its first measurement.
These actions are:
o WET-UP procedure: A standby solution moistens the Sensor Cartridge and
activates it at an increased temperature
o Couple check: This ensures that the correct temperatures for BG (37° C) and
ISE/Glu/Lac (30° C) parameters can be maintained
o Swelling time: Time between the end of the couple check and the first system
calibration
o First system calibration: New calibration data are generated during this
calibration. It takes longer than a normal system calibration
RUN-IN phase The RUN-IN phase begins after the START-UP phase and continues for a specific
time, which is defined on the Sensor Cartridge.
During the RUN-IN phase, you can measure without any impact to their accuracy or
precision. However, sample measurement times are longer.
Stable phase The stable phase begins at the end of the RUN-IN phase and ends when the in-use
time of the Sensor Cartridge expires.
IN-USE time The IN-USE time is the time from the beginning of the RUN-IN phase to the end of
the stable phase.
Roche Diagnostics
BG sensors
BG sensors measure pH, PO2, PCO2 and Hct parameters.
A
B
C
D
E
F
G
A Conductivity contact E CO2 measuring contact

B O2 measuring contact F pH sensor (BG)
C O2 reference contact G Conductivity contact
D CO2 reference contact
Figure 2-20 BG sensor
PO2 sensor Uses the Clark measurement principle. Oxygen is diffused through a membrane to a
gold multi-wire system with negative electric potential inside of the sensor. Oxygen is
reduced here, which generates an electric current that is proportional to the amount
of oxygen in the sample. This measurement is amperometric.
PCO2 sensor Uses the Severinghouse principle. CO2 diffuses through a membrane similar to the
PO2 sensor. In the sensor, change in CO2 concentration affects the pH. This
measurement is potentiometric.
pH sensor The pH sensor consists of a pH-sensitive membrane. Depending on the pH value of

the sample, electric potential is generated at the boundary layer between the
membrane and the sample. This potential can be measured potentiometrically by a
second sensor, the reference sensor (in the ISE sensor part).
Roche Diagnostics
ISE sensors
ISE sensors measure Na+, K+, Ca2+, and Cl- electrolyte values.
A
B
C
D
E
F
G
A Cl- sensor E Na+ sensor

B pH sensor (ISE) F Conductivity contact
C Ca2+ sensor G ISE reference sensor
D K+ sensor
Figure 2-21 ISE sensor
Na+, K+, Ca2+, Cl- sensors These sensors consist of electrolyte-sensitive membranes. Their measurement is
potentiometric.
Reference sensor The reference sensor uses a reference solution, containing a high KCl concentration,
to compare electrolyte concentrations for each sample.
Roche Diagnostics
Glu/Lac sensors
Glu/Lac sensors measure glucose and lactate.
A
B
C
D
E
F
G
H
A BSA sensor E Glucose reference sensor

B Lactate counter electrode F Glucose sensor
C Lactate sensor G Glucose counter electrode
D Lactate reference sensor H Conductivity contact
Figure 2-22 Glu/Lac sensors
Glucose sensor Glucose oxidizes to form gluconolacton using atmospheric oxygen and the glucose-
oxidase enzyme. The generated H2O2 is determined amperometrically by using the
manganese dioxide/carbon electrode at 350 mV.
Lactate sensor Lactate oxidizes to form pyruvate using the lactate-oxidase enzyme. The generated
H2O2 is determined amperometrically by using the manganese dioxide/carbon
electrode at 350 mV.
Roche Diagnostics
Fluid Pack
A B C D E
A Tubing (peristaltic pump) D Docking parts (measuring chamber module)

B Cuvette (oximeter module) E Sample input module
C Sample sensor contacts
Figure 2-23 cobas b 123 Fluid Pack
The Fluid Pack contains:

o 7 bags:
O 2 waste water containers
O 1 reference solution
O 1 wetting solution (to wet the Sensor Cartridge)
O 1 standby solution (STDBY) (for recalibration and standby calibration)
O Calibration solution CAL 1
O Calibration solution CAL 2
o Sample input module (fill port and needle)
o Tubing
o Cuvette for oximeter module (optional)
An air filter is integrated in the base of the Fluid Pack to control the temperature of
the system’s modules.
Fluid Pack types Different Fluid Packs are available to support your testing frequency.
Roche Diagnostics
All Fluid Packs have to be changed after 42 days.

u Fluid Pack types (p. 335)
q If you perform fewer tests than the test frequency for your Fluid Pack, you will not be able
to perform as many tests as expected with your Fluid Pack.
Memory chip A memory chip is attached on the rear side of the Fluid Pack to exchange data
between the Fluid Pack and the instrument.
A Smart memory chip
Figure 2-24 Smart memory chip
q Do not touch the memory chip.
Operating fluids All calibration and wash solutions for operating the instrument, and 2 waste water
containers are located in the Fluid Pack. Operating fluids are filled into heat-sealed
bags.
The bag valves are controlled by the instrument and release fluid from the bags, but
can also be set to the shutoff or air position.
Tubing All tubing for operation, including the pump tubes for both peristaltic pumps and the
valve tubing, are integrated into the Fluid Pack.
The valves and peristaltic pumps are at the back of the Fluid Pack.
Sample sensor contacts The sample sensor contacts form the electrical interface between the Fluid Pack and
the measuring chamber module.
Roche Diagnostics
A Sample sensor contacts on the Fluid Pack B Sample sensor contacts inside the
measuring chamber module
Figure 2-25 Sample sensor contacts
q Do not touch the sample sensor contacts on the Fluid Pack.
Sample input module The fill port aspirates samples from syringes, capillaries,
Roche MICROSAMPLER PROTECT, and ampoule adapters.
A Sample input module B Fill port (capillary position) C Fill port (syringe position)
Figure 2-26 Sample input module
Roche Diagnostics
Cuvette
A
B
A Sample sensor contacts B Cuvette
Figure 2-27 Cuvette
The cuvette is connected to the oximeter module.
q Do not touch the cuvette on the Fluid Pack.
cobas b 123 AutoQC Pack (optional)
Figure 2-28 cobas b 123 AutoQC Pack TRI-LEVEL
AutoQC modules are available for the cobas b 123 POC system to provide regular,
automated quality control.
The advantage of this system is that the QC fluid is withdrawn directly from the
ampoule using the sample needle. The QC measurement procedure for transporting
and handling samples is the same procedure as for sample measurements. Special
sample handling for QC materials is therefore not needed.
Roche Diagnostics
This module is included in the cobas b 123 <2> POC system and
cobas b 123 <4> POC system variants.
AutoQC Packs are found inside AutoQC modules, and contain 24 glass ampoules in
a revolving carousel. These ampoules are filled with QC material from 3 different
levels.
AutoQC Pack types Currently, the following versions of the cobas b 123 AutoQC Pack are available:
cobas b 123 AutoQC Pack TRI-LEVEL Level 1–3 for low, normal and high values
u QC material (p. 336)
Memory chip
A Smart memory chip of the cobas b 123 AutoQC Pack
Figure 2-29 cobas b 123 AutoQC Pack
Turning over an AutoQC Pack may result in spilled liquid

Reinstalling an AutoQC Pack that has been turned over may result in spilled AutoQC
CAUTION material.In addition, glass splinters from broken QC ampoules may impair the functioning
of the AutoQC module.
r If you plan on reinstalling a used AutoQC Pack, keep it in an upright position when it is
outside of the instrument.
r If liquid does spill from the AutoQC Pack, wipe it up immediately and apply a
disinfectant. Wear appropriate personal protective equipment.
A memory chip is attached on the rear side of the AutoQC Pack to exchange data
between the AutoQC Pack and the instrument.
q Do not touch the memory chip.
Roche Diagnostics
cobas b 123 POC system 3 Specifications
Table of contents
Specifications 3
In this chapter, the system’s performance, product and environmental data are
provided.

Performance data..................................................................................................................55
Measurement parameters..............................................................................................55
Precision (sample mode: normal)................................................................................55
pH ..............................................................................................................................56
PO2.............................................................................................................................56
PCO2 ..........................................................................................................................57
Na+ .............................................................................................................................57
K+ ...............................................................................................................................58
Cl- ...............................................................................................................................59
Ca2+ ...........................................................................................................................60
Hct..............................................................................................................................60
Lac..............................................................................................................................61
Glu..............................................................................................................................62
tHb .............................................................................................................................62
SO2 .............................................................................................................................63
O2Hb .........................................................................................................................64
COHb ........................................................................................................................64
MetHb .......................................................................................................................65
HHb ...........................................................................................................................65
Bili ..............................................................................................................................66
Precision (sample mode: micro sample) .....................................................................66
pH ..............................................................................................................................67
PO2.............................................................................................................................67
PCO2 ..........................................................................................................................68
Hct..............................................................................................................................68
tHb .............................................................................................................................68
SO2 .............................................................................................................................69
O2Hb .........................................................................................................................69
COHb ........................................................................................................................70
MetHb .......................................................................................................................70
Roche Diagnostics
3 Specifications cobas b 123 POC system
Table of contents
HHb ...........................................................................................................................71
Bili ..............................................................................................................................71
Linearity (normal sample) ............................................................................................72
Material: tonometered whole blood ......................................................................72
Material: prepared whole blood.............................................................................72
Material: prepared whole blood, including bilirubin..........................................73
Material: prepared dialysis solution ......................................................................73
Linearity (micro sample)...............................................................................................73
Material: tonometered whole blood ......................................................................73
Material: prepared whole blood.............................................................................74
Material: prepared whole blood, including bilirubin..........................................74
Correlation to other methods.......................................................................................74
pH ..............................................................................................................................74
PO2.............................................................................................................................74
PCO2 ..........................................................................................................................75
tHb (cobas b 123 POC system with COOX module).........................................75
O2Hb (cobas b 123 POC system with COOX module) .....................................75
HHb (cobas b 123 POC system with COOX module).......................................75
MetHb (cobas b 123 POC system with COOX module) ...................................75
COHb (cobas b 123 POC system with COOX module) ....................................76
Bili ..............................................................................................................................76
SO2 (cobas b 123 POC system with COOX module).........................................76
Hct..............................................................................................................................76
Na+ .............................................................................................................................76
K+ ...............................................................................................................................77
Ca2+ ...........................................................................................................................77
Cl- ...............................................................................................................................77
Glu..............................................................................................................................78
Lac..............................................................................................................................78
Comparison of micro samples to normal samples ....................................................78
Sample throughput...............................................................................................................79
Sample measurement time ..................................................................................................80
Sample volumes ....................................................................................................................81
Sample types..........................................................................................................................82
Calibrations ...........................................................................................................................83
Environmental parameters..................................................................................................84
Temperature/humidity/stability ...................................................................................84
Instrument ................................................................................................................84
Sensor Cartridge ......................................................................................................84
Fluid Pack..................................................................................................................85
QC material ..............................................................................................................85
Product data..........................................................................................................................86
Electrical data .................................................................................................................86
Classification (according IEC/ISO) .............................................................................86
Dimensions .....................................................................................................................86
Weight..............................................................................................................................86
Acoustic noise level........................................................................................................86
Holding points................................................................................................................87
Printer ....................................................................................................................................88
User interface module..........................................................................................................89
Roche Diagnostics
Table of contents
Barcode scanner ...................................................................................................................90

Imaging scanner (optional).................................................................................................92
Roche Diagnostics
Table of contents
Roche Diagnostics
Performance data
Performance data
Measurement parameters
Parameter Specified sample types Specified ranges

PO2 B/Q/C 10–700 mmHg
PCO2 B/Q/C 10–150 mmHg
pH B/Q/C 6.5–8.0
Na+ B/Q/C 100–200 mmol/L
DS 120–155 mmol/L
K + B/Q/C 1.0–15 mmol/L
DS 1.0–6.0 mmol/L
Cl- B/Q/C 70–150 mmol/L
Ca2+ B/Q/C 0.1–2.5 mmol/L 0.4008–10.02 mg/dL

DS 0.9–1.85 mmol/L 3.6072–7.42 mg/dL
Hct B/Q 10–75%
Glu B/Q/C 1.0–30 mmol/L 18.016–540.48 mg/dL
Lac B/Q/C 1.0–20 mmol/L 9.0080–180.16 mg/dL
tHb (COOX) B/Q 4–25 g/dL
SO2 (COOX) B/Q 30–100%
HHb (COOX) B/Q 0–70%
COHb (COOX) B/Q 0–70%
O2Hb (COOX) B/Q 30–100%
MetHb (COOX) B/Q 0–70%
Bili (neonatal) (COOX) B/Q 3–50 mg/dL 51.3–855 μmol/L
Baro 530–800 mmHg
Table 3-1 Measurement parameters
B Whole blood
DS Dialysis solution
Q Aqueous QC material(1)
C Aqueous solution
(1) with approximate physiological ion matrix and buffer capacity.
Precision (sample mode: normal)
“Repeatability (SR)” and “Intermediate precision (SI)” were determined from 2 runs
per day with 2 replicated per run for 20 days using the cobas b 123 POC system.
The mean value is the measured value of the corresponding parameter for which SR
and SI are representative or have been determined.
Roche Diagnostics
Performance data
Tonometered whole blood Whole blood was tonometered at 37°C with high-precision gas mixtures.
Prepared whole blood Expected values for prepared whole blood are based on reference methods.
pH
Unit: [pH units]
Material: prepared human whole blood, n=40
Mean SR (CV%) SI (CV%)

Sample 1 7.237 0.0029 0.04 0.0033 0.04
Sample 2 7.441 0.0029 0.03 0.0032 0.04
Sample 3 7.568 0.0054 0.07 0.0050 0.06
Table 3-2 pH material
Material: cobas b 123 AutoQC Pack TRI-LEVEL, n=80

Level 1 7.149 0.0026 0.04 0.0059 0.08
Level 2 7.393 0.0016 0.02 0.0043 0.06
Level 3 7.543 0.0016 0.02 0.0044 0.06
Material: cobas b 123 AutoCVC Pack, n=80

Level 4 6.883 0.0017 0.02 0.0083 0.12
Level 5 7.731 0.0015 0.02 0.0061 0.08
PO2
Unit: [mmHg]
Material: tonometered human whole blood, 20 different probands, n=80

Sample 1 145.4 0.7404 0.51 3.2402 2.23
Sample 2 40.5 0.6888 1.70 2.4680 6.09
Sample 3 352.2 2.0866 0.59 8.7645 2.49
Table 3-5 PO2 material

Level 1 58.5 1.0476 1.79 1.7558 3.00
Level 2 98.7 1.6680 1.69 3.5239 3.57
Level 3 147.6 1.1515 0.78 4.6708 3.17
Roche Diagnostics
Performance data

Level 4 28.9 1.8232 6.32 2.3972 8.31
Level 5 448.5 5.6049 1.25 16.8744 3.76
PCO2
Unit: [mmHg]
Material: tonometered human whole blood, 20 different probands, n=80

Sample 1 23.5 0.1174 0.50 0.5186 2.21
Sample 2 72.7 0.3728 0.51 2.3130 3.18
Sample 3 128.6 1.7942 1.39 3.3567 2.61
Table 3-8 PCO2 material

Level 1 64.2 0.4441 0.69 1.0526 1.64
Level 2 41.9 0.2699 0.64 0.6055 1.44
Level 3 25.7 0.0935 0.36 0.4348 1.69

Level 4 123.5 0.7458 0.60 3.3313 2.70
Level 5 19.2 0.1436 0.75 0.4081 2.12
Na+
Unit: [mmol/L]

Sample 1 117.7 0.2845 0.24 0.5352 0.45
Sample 2 138.6 0.2709 0.19 0.4388 0.31
Sample 3 156.2 0.5890 0.37 0.5361 0.34
Table 3-11 Na+ material
Roche Diagnostics
Performance data

Level 1 117.4 0.3946 0.34 0.5152 0.44
Level 2 141.0 0.1519 0.11 0.4866 0.35
Level 3 153.7 0.4462 0.29 0.8063 0.52
+
Table 3-12 Na material

Level 4 113.2 0.1765 0.16 0.7363 0.65
Level 5 177.5 0.2032 0.11 1.2176 0.69
+
Table 3-13 Na material
Material: plasma, n=80

Normal level 140.7 0.6789 0.48 1.8788 1.34
High level 160.9 0.2104 0.13 0.9028 0.56
Material: prepared dialysis solution, n=80

Level 1 122.5 0.3801 0.31 0.5162 0.42
Level 2 139.1 0.3207 0.23 0.4397 0.32
Level 3 150.5 0.2882 0.19 0.4577 0.30
K+
Unit: [mmol/L]

Sample 1 3.05 0.0221 0.72 0.0228 0.74
Sample 2 5.00 0.0148 0.29 0.0198 0.39
Sample 3 6.10 0.0198 0.32 0.0238 0.39
Table 3-16 K+ material

Level 1 2.98 0.0110 0.37 0.0170 0.57
Level 2 4.72 0.0070 0.15 0.0174 0.37
Level 3 7.01 0.0225 0.32 0.0515 0.74
Roche Diagnostics
Performance data

Level 4 9.25 0.0152 0.16 0.1166 1.26
Level 5 2.02 0.0060 0.30 0.0292 1.44
+
Table 3-18 K material

Normal level 3.67 0.0161 0.44 0.0476 1.30
High level 6.45 0.0104 0.16 0.1259 1.95
+
Table 3-19 K material

Level 1 1.28 0.0086 0.67 0.0239 1.87
Level 2 3.97 0.0061 0.15 0.0131 0.33
Level 3 5.76 0.0053 0.09 0.0157 0.27
Cl-
Unit: [mmol/L]

Sample 1 78.2 0.3529 0.45 0.6415 0.82
Sample 2 101.4 0.3478 0.34 0.4932 0.48
Sample 3 126.6 0.7057 0.55 0.7989 0.63
Table 3-21 Cl- material

Level 1 81.5 0.5086 0.62 1.3698 1.68
Level 2 99.5 0.2633 0.26 1.0743 1.08
Level 3 115.6 0.3831 0.33 1.0635 0.92

Level 4 89.4 0.0815 0.09 0.4791 0.54
Level 5 133.5 0.3652 0.27 1.9308 1.45
Roche Diagnostics
Performance data

Normal level 105.0 0.3959 0.38 1.5632 1.49
High level 125.6 0.2029 0.16 1.1795 0.94
-
Table 3-24 Cl material
Ca2+
Unit: [mmol/L]

Sample 1 0.72 0.01 1.07 0.01 1.85
Sample 2 1.18 0.01 0.79 0.02 1.79
Sample 3 1.40 0.02 1.25 0.02 1.25
2+
Table 3-25 Ca material

Level 1 1.709 0.0105 0.61 0.0132 0.77
Level 2 1.219 0.0029 0.24 0.0045 0.37
Level 3 0.661 0.0049 0.74 0.0061 0.92
Table 3-26 Ca2+ material

Level 4 2.157 0.0053 0.25 0.0168 0.78
Level 5 0.400 0.0025 0.63 0.0076 1.89

Normal level 1.079 0.0129 1.20 0.0389 3.61
High level 1.026 0.0066 0.64 0.0088 0.86

Level 1 1.831 0.0126 0.69 0.0189 1.03
Level 2 1.338 0.0066 0.49 0.0100 0.75
Level 3 0.953 0.0036 0.38 0.0062 0.65
Hct
Unit: [%]
Roche Diagnostics
Performance data

Sample 1 22.1 0.2461 1.11 0.3649 1.65
Sample 2 38.5 0.1597 0.41 0.4427 1.14
Sample 3 62.3 0.2370 0.38 0.5559 0.89
Table 3-30 Hct material

Level 1 58.9 0.1416 0.24 0.4716 0.80
Level 2 40.9 0.0874 0.21 0.4306 1.05
Level 3 32.5 0.0732 0.22 0.3460 1.06

Level 5 19.0 0.0731 0.38 0.2233 1.18
Level 6 63.6 0.0573 0.09 0.4745 0.75
Lac
Unit: [mmol/L]

Sample 1 0.90 0.01 1.18 0.07 8.11
Sample 2 1.40 0.01 0.69 0.10 7.10
Sample 3 3.60 0.06 1.56 0.20 5.55
Table 3-33 Lac material

Level 1 10.7 0.0399 0.37 0.2491 2.34
Level 2 3.2 0.0076 0.24 0.0647 2.03
Level 3 1.7 0.0056 0.32 0.0464 2.65

Level 5 6.3 0.0653 1.04 0.1489 2.37
Level 6 14.2 0.1022 0.72 0.4257 3.00
Roche Diagnostics
Performance data

Normal level 5.6 0.0894 1.61 0.1525 2.75
High level 5.3 0.0462 0.87 0.2002 3.75
Glu
Unit: [mmol/L]

Sample 1 2.60 0.06 2.28 0.16 6.11
Sample 2 5.00 0.06 1.27 0.25 4.91
Sample 3 27.10 0.15 0.56 1.42 5.24
Table 3-37 Glu material

Level 1 6.1 0.0361 0.59 0.1015 1.67
Level 2 2.6 0.0221 0.85 0.0584 2.23
Level 3 25.0 0.0930 0.37 0.5734 2.29

Level 5 2.5 0.0229 0.91 0.0886 3.55
Level 6 25.5 0.1963 0.77 0.7065 2.77
Material: aqueous solution with increased glucose value, n=80

Sample 1 28.1 0.3642 1.30 0.8414 3.00

Normal level 4.1 0.0623 1.52 0.1431 3.48
High level 28.6 0.1678 0.59 0.8775 3.07
tHb
Unit: [g/dL]
Roche Diagnostics
Performance data

Sample 1 6.5 0.1058 1.62 0.0938 1.44
Sample 2 12.9 0.0874 0.67 0.1298 1.00
Sample 3 20.7 0.0703 0.33 0.1402 0.67
Table 3-42 tHb material

Level 1 7.1 0.0469 0.66 0.1624 2.29
Level 2 11.5 0.0830 0.72 0.1281 1.12
Level 3 19.6 0.1613 0.82 0.2362 1.21

Level 5 6.1 0.0368 0.60 0.1303 2.12
Level 6 21.7 0.1368 0.63 0.2309 1.06
SO2
Unit: [%]
Material: tonometered human whole blood, n=40

Sample 1 82.6 1.2561 1.52 1.1740 1.42
Sample 2 96.8 0.4976 0.51 0.6130 0.63
Sample 3 99.7 0.1190 0.11 0.1639 0.16
Table 3-45 SO2 material

Level 1 73.4 0.0937 0.13 0.2069 0.28
Level 2 90.3 0.2058 0.23 0.2343 0.26
Level 3 97.1 0.1434 0.15 0.1490 0.15

Level 5 68.2 0.1057 0.16 0.1868 0.27
Level 6 98.0 0.1434 0.15 0.1370 0.14
Roche Diagnostics
Performance data
O2Hb
Unit: [%]

Sample 1 80.6 1.2296 1.52 1.1741 1.45
Sample 2 94.5 0.5108 0.54 0.6363 0.67
Sample 3 97.4 0.1342 0.13 0.2651 0.27
Table 3-48 O2Hb material

Level 1 48.3 0.1188 0.25 0.2616 0.54
Level 2 75.8 0.4170 0.55 0.4746 0.63
Level 3 92.0 0.3703 0.40 0.3849 0.42

Level 5 42.1 0.1177 0.28 0.2080 0.49
Level 6 94.3 0.3817 0.40 0.3647 0.39
COHb
Unit: [%]

Sample 1 2.0 0.0946 4.73 0.2316 11.58
Sample 2 5.4 0.0688 1.27 0.2238 4.14
Sample 3 13.4 0.0894 0.66 0.1997 1.49
Table 3-51 COHb material

Level 1 22.4 0.0530 0.24 0.1164 0.52
Level 2 10.4 0.1860 1.78 0.2115 2.03
Level 3 3.5 0.1633 4.63 0.1699 4.82
Roche Diagnostics
Performance data

Level 5 25.1 0.0525 0.21 0.0926 0.37
Level 6 2.5 0.1685 6.65 0.1611 6.36
MetHb
Unit: [%]

Sample 1 1.3 0.0672 5.16 0.0975 7.50
Sample 2 5.8 0.1125 1.93 0.1106 1.90
Sample 3 30.7 0.3221 1.04 0.3181 1.03
Table 3-54 MetHb material

Level 1 11.7 0.0242 0.21 0.0537 0.46
Level 2 5.7 0.0849 1.49 0.0968 1.70
Level 3 2.0 0.0783 3.98 0.0812 4.13

Level 5 13.1 0.0240 0.18 0.0426 0.33
Level 6 1.4 0.0804 5.67 0.0768 5.41
HHb
Unit: [%]

Sample 1 5.2 0.1828 3.51 0.3268 6.28
Sample 2 9.5 0.2190 2.31 0.3718 3.91
Sample 3 17.0 1.2248 7.20 1.1417 6.71
Table 3-57 HHb material
Roche Diagnostics
Performance data

Level 1 17.6 0.0414 0.24 0.0909 0.52
Level 2 8.2 0.1451 1.78 0.1651 2.02
Level 3 2.7 0.1279 4.73 0.1329 4.92

Level 5 19.7 0.0410 0.21 0.0723 0.37
Level 6 1.9 0.1319 6.88 0.1260 6.58
Bili
Unit: [mg/dL]

Level 1 5.8 0.0247 0.43 0.1176 2.03
Level 2 11.7 0.0988 0.84 0.1532 1.31
Level 3 20.2 0.2123 1.05 0.2663 1.32
Table 3-60 Bili material

Level 5 4.7 0.0183 0.39 0.0915 1.96
Level 6 22.2 0.1650 0.74 0.2292 1.03
Material: prepared whole blood, including bilirubin, n=40

Sample 1 5.3 0.113 2.12 0.245 4.60
Sample 2 14.74 0.132 0.90 0.255 1.73
Sample 3 23.20 0.111 0.48 0.389 1.68
Precision (sample mode: micro sample)
“Repeatability (SR)” and “Intermediate precision (SI)” were determined using the
cobas b 123 POC system for 10 days.
The mean value is the measured value of the corresponding parameter for which SR
and SI are representative or have been determined.
Roche Diagnostics
Performance data
Prepared whole blood including. Expected bilirubin values for human whole blood, including bilirubin, are NIST
bilirubin traceable, based on weighted samples or reference methods.
pH
Unit: [pH units]
Parameter group: BG only

Sample 1 7.143 0.0049 0.07 0.0087 0.12
Sample 2 7.433 0.0031 0.04 0.0061 0.08
Sample 3 7.702 0.0077 0.10 0.0085 0.11
Parameter group: BG and COOX

Sample 1 7.146 0.0060 0.08 0.0079 0.11
Sample 2 7.426 0.0044 0.06 0.0066 0.09
Sample 3 7.694 0.0051 0.07 0.0060 0.08
PO2
Unit: [mmHg]

Sample 1 140.5 0.7496 0.53 2.9134 2.10
Sample 2 45.7 0.5529 1.21 3.0277 6.62
Sample 3 327.8 2.2800 0.70 8.8025 2.69

Sample 1 140.8 1.0871 0.77 3.4533 2.45
Sample 2 45.8 0.6555 1.43 3.4589 7.54
Sample 3 332.5 3.7003 1.11 10.0589 3.03
Roche Diagnostics
Performance data
PCO2
Unit: [mmHg]

Sample 1 68.4 0.4721 0.69 1.0934 1.60
Sample 2 122.7 1.4066 1.15 2.4542 2.00
Sample 3 24.3 0.1840 0.76 0.5821 2.40

Sample 1 69.3 0.7461 1.08 1.0505 1.52
Sample 2 126.3 1.8925 1.50 2.7580 2.18
Sample 3 24.3 0.2841 1.17 0.6432 2.65
Hct
Unit: [%]

Sample 1 22.9 1.3787 6.01 1.5121 6.59
Sample 2 47.9 0.5614 1.17 0.6163 1.29
Sample 3 66.3 0.8662 1.31 1.1438 1.73

Sample 1 22.7 0.5613 2.48 0.6156 2.72
Sample 2 48.3 1.5060 3.12 1.5797 3.27
Sample 3 67.1 1.1035 1.64 1.6227 2.42
tHb
Unit: [g/dL]
Roche Diagnostics
Performance data

Sample 1 7.1 0.0639 0.90 0.1016 1.43
Sample 2 16.2 0.1978 1.22 0.3517 2.17
Sample 3 19.9 0.3303 1.66 0.2962 1.49
Parameter group: COOX only

Sample 1 7.0 0.1643 2.36 0.1584 2.27
Sample 2 16.4 0.1985 1.21 0.3125 1.91
Sample 3 20.3 0.1113 0.55 0.2787 1.37
SO2
Unit: [%]

Sample 1 81.5 0.9869 1.21 1.1530 1.42
Sample 2 96.3 0.6119 0.64 0.6813 0.71
Sample 3 99.8 0.0725 0.07 0.1437 0.14

Sample 1 82.5 0.7237 0.88 0.9243 1.12
Sample 2 96.7 0.3895 0.40 0.5919 0.61
Sample 3 99.7 0.1283 0.13 0.1902 0.19
O2Hb
Unit: [%]
Roche Diagnostics
Performance data

Sample 1 79.8 0.9521 1.19 1.1771 1.48
Sample 2 94.3 0.5132 0.54 0.6293 0.67
Sample 3 97.8 0.0734 0.08 0.2777 0.28

Sample 1 80.8 0.7441 0.92 0.9247 1.15
Sample 2 94.7 0.3349 0.35 0.6138 0.65
Sample 3 97.8 0.1145 0.12 0.2440 0.25
COHb
Unit: [%]

Sample 1 1.4 0.0676 4.78 0.1780 12.58
Sample 2 4.0 0.1092 2.70 0.1915 4.73
Sample 3 13.9 0.0823 0.59 0.1766 1.27

Sample 1 1.4 0.0613 4.34 0.1824 12.91
Sample 2 4.0 0.0677 1.67 0.1893 4.67
Sample 3 13.9 0.0655 0.47 0.1577 1.14
MetHb
Unit: [%]
Roche Diagnostics
Performance data

Sample 1 0.9 0.1104 12.94 0.1329 15.59
Sample 2 5.3 0.0851 1.61 0.1105 2.09
Sample 3 36.4 0.9648 2.65 0.7701 2.12

Sample 1 0.9 0.1470 17.10 0.1653 19.22
Sample 2 4.4 0.1368 3.12 0.1554 3.54
Sample 3 38.5 0.7735 2.01 0.5996 1.56
HHb
Unit: [%]

Sample 1 0.2 0.0712 34.88 0.1407 68.96
Sample 2 3.6 0.6032 16.55 0.6698 18.38
Sample 3 18.2 0.9752 5.37 1.1243 6.19

Sample 1 0.3 0.1258 48.71 0.1866 72.29
Sample 2 3.2 0.4958 12.03 0.5058 18.17
Sample 3 17.1 0.7014 4.11 0.9031 5.29
Bili
Unit: [mg/dL]
Roche Diagnostics
Performance data
Material: prepared whole blood including, bilirubin, n=20

Sample 1 5.2 0.3588 6.93 0.6710 12.95
Sample 2 9.8 0.6240 6.38 0.8738 8.93
Sample 3 14.7 0.4676 3.18 0.8140 5.53
Table 3-83 Bilirubin material
Material: prepared whole blood including, bilirubin, n=20

Sample 1 5.2 0.1721 3.31 0.6081 11.71
Sample 2 9.7 0.2864 2.94 0.6832 7.03
Sample 3 13.7 0.3169 2.31 0.4290 3.12
Table 3-84 Bilirubin material
Linearity (normal sample)
bilirubin traceable, based on weighted samples or reference methods.
Prepared dialysis solution Expected values for prepared dialysis solution are based on reference methods.
Material: tonometered whole blood

Number of cobas b 123 <4> POC system instruments: 4
Parameter Unit Coefficient (Pearson) Range n

PCO2 [mmHg] 0.9990 10.27–172.81 197
PO2 [mmHg] 0.9966 8.90–604.68 200
Table 3-85 Material: tonometered whole blood
Material: prepared whole blood


pH [---] 0.9996 6.499–8.319 40
Na+ [mmol/L] 0.9993 88.16–212.3 36
K+ [mmol/L] 0.9989 0.752–16.61 34
Cl- [mmol/L] 0.9990 58.5-167.4 36

2+ [mmol/L] 0.985 0.756–12.84 36
Ca
Lac [mmol/L] 0.9969 4.1–214.3 36
Table 3-86 Material: prepared whole blood
Roche Diagnostics
Performance data

Glu [mmol/L] 0.9942 11.1–543.4 36
Hct [%] 0.9934 8.3–81.0 66
tHb [g/dL] 0.9972 3.132–27.01 194
SO2 [%] 0.9990 31.8–99.6 80
O2Hb [%] 0.9991 3.2–98.1 615
COHb [%] 0.9999 1.0–78.9 167
MetHb [%] 1.0000 0.6–79.2 295
HHb [%] 0.9989 0.0–95.0 615
Material: prepared whole blood, including bilirubin


Bili [mg/dL] 0.998 3.08–48.3 80
Table 3-87 Material: prepared whole blood, including bilirubin
Material: prepared dialysis solution

Na+ [mmol/L] 0.9998 108.3–169.1 42
K+ [mmol/L] 0.9996 0.62–7.01 42

2+ [mmol/L] 0.9998 0.764–1.971 42
Ca
Table 3-88 Material: prepared dialysis solution
Linearity (micro sample)
bilirubin traceable, based on weighted samples or based on reference methods.
Material: tonometered whole blood

Number of cobas b 123 POC system instruments: 8

PCO2 [mmHg] 1.000 3.6–183.3 127
PO2 [mmHg] 1.000 0–659.5 144
Table 3-89 Material: tonometered whole blood
Roche Diagnostics
Performance data
Material: prepared whole blood


pH [---] 1.000 6.34–8.12 70
Hct [%] 1.000 11.7–81.7 198
tHb [g/dL] 1.000 3–29 580
SO2 [%] 1.000 29–100 404
O2Hb [%] 1.000 28.4–98.0 403
COHb [%] 1.000 5.7–79.7 438
MetHb [%] 1.000 4.3–80.9 449
HHb [%] 1.000 0–69.57 403
Material: prepared whole blood, including bilirubin


Bili [mg/dL] 1.000 3.4–47.9 566
Table 3-91 Material: prepared whole blood, including bilirubin
Correlation to other methods
pH
Unit: [pH units]
Material: whole blood
Comparison instrument No. of samples [n] Bias(1) Slope [b] Intercept [a] Pearson’s Corr. coeff. [r]
cobas b 221 system 691 0.009 0.99 0.08 0.99
Table 3-92 pH
(1) Median absolute bias
PO2
Unit: [mmHg]
cobas b 221 system 677 --- 0.97 -0.76 1.00
Table 3-93 PO2
Roche Diagnostics
Performance data
PCO2
Unit: [mmHg]
cobas b 221 system 687 -0.2 0.95 1.85 0.99
Table 3-94 PCO2
tHb (cobas b 123 POC system with COOX module)

Unit: [g/dL]
cobas b 221 system 682 -0.3 0.95 0.25 0.98
Table 3-95 tHb
O2Hb (cobas b 123 POC system with COOX module)

Unit: [%]
cobas b 221 system 666 0.5 1.01 -0.17 1.00
Table 3-96 O2Hb
HHb (cobas b 123 POC system with COOX module)

Unit: [%]
cobas b 221 system 668 -0.6 1.01 -0.72 1.00
Table 3-97 HHb
MetHb (cobas b 123 POC system with COOX module)

Unit: [%]
cobas b 221 system 682 0.1 1.00 0.10 0.67
Table 3-98 MetHb
Roche Diagnostics
Performance data
COHb (cobas b 123 POC system with COOX module)

Unit: [%]
cobas b 221 system 682 0.0 1.00 0.00 0.97
Table 3-99 COHb
Bili
Unit: [mg/dL]
Material: whole blood (neonatal)
cobas b 221 system 162 0.02 1.0 -0.15 0.994
Table 3-100 Bili
SO2 (cobas b 123 POC system with COOX module)

Unit: [%]
cobas b 221 system 484 0.431 0.9861 1.5720 0.9992
Table 3-101 SO2
Hct
Unit: [%]
cobas b 221 system 691 -0.1 0.95 1.62 0.99
Table 3-102 Hct
Na+
Unit: [mmol/L]
cobas b 221 system 691 0.02 1.03 -4.57 0.94
Table 3-103 Na+
Roche Diagnostics
Performance data
cobas b 221 system 229 1.43 0.97 6.65 0.98
+
Table 3-104 Na
K+
Unit: [mmol/L]
cobas b 221 system 682 -0.03 0.96 0.15 0.99
+
Table 3-105 K
cobas b 221 system 230 0.00 1.00 0.01 1.00
Table 3-106 K+
Ca2+
Unit: [mmol/L]
cobas b 221 system 689 -0.010 0.95 0.05 0.94
Table 3-107 Ca2+
cobas b 221 system 227 2.93 1.03 -0.01 0.99
Table 3-108 Ca2+
Cl-
Unit: [mmol/L]
cobas b 221 system 657 1.2 1.15 -14.91 0.98
Table 3-109 Cl-
Roche Diagnostics
Performance data
Glu
Unit: [mmol/L]
cobas® 6000 686 -2.4 0.98 -0.04 0.98
Table 3-110 Glu
Lac
Unit: [mmol/L]
cobas® 6000 590 --- 1.00 0.06 0.99
Table 3-111 Lac
Comparison of micro samples to normal samples
The trueness of measurement values in micro sample mode, BG-only (40 μL) and BG
with COOX (55 μL), have been confirmed by comparing measurement values in
normal sample mode (150 μL).
Number of instruments: 8 cobas b 123 POC systems
Parameter Unit No. of samples [n] Bias(1) Slope [b] Intercept [a] Pearson’s Corr. coeff. [r]
pH [pH units] 149 0.00 0.9932 0.0506 0.9996
PO2 [mmHg] 205 0.564 0.994 1.0251 0.9995
PCO2 [mmHg] 133 0.09 0.9646 1.4684 0.9989
Hct [%] 370 -0.026 1.0034 -0.1195 0.9988
tHb [g/dL] 244 -0.044 1.033 -0.4168 0.9998
O2Hb [%] 403 0.571 0.9806 2.1444 0.9993
HHb [%] 403 -0.558 0.9799 -0.2087 0.9993
MetHb [%] 176 -0.332 0.9948 -0.0827 0.9999
COHb [%] 278 -0.034 1.0001 -0.038 1.0000
SO2 [%] 484 0.431 0.9861 1.572 0.9992
Bili [mg/dL] 232 -0.506 0.9975 -0.4805 0.9982
Table 3-112 Sample comparison data
Roche Diagnostics
Sample throughput
Sample throughput
Activated/installed modules Sample throughput [samples/hours]

Syringe/Capillary
BG - ISE - Hct - Glu - Lac 30
BG - ISE - Hct - Glu - Lac - AutoQC 30
BG - ISE - Hct - Glu - Lac - COOX 30
BG - ISE - Hct - Glu - Lac - COOX - AutoQC 30
Table 3-113 Sample throughput
Roche Diagnostics
Sample measurement time
Sample measurement time
Measurement times [seconds]

Activated/installed modules
Total time Until display
BG - ISE - Hct - Glu - Lac 120 120
BG - ISE - Hct - Glu - Lac - COOX 120 120
Table 3-114 Sample measurement time
q During the RUN-IN phase, you can measure without any impact to their accuracy or
precision. However, sample measurement times are longer.
u Sensor phases (p. 42)
Roche Diagnostics
Sample volumes
Sample volumes
q Minimum sample volumes depend on Hct concentration.

Maximum sample volumes depend on which modules are installed. It does not depend on
whether the modules are activated or deactivated.
Activated/installed modules Typical sample volume [μL](1) Maximum sample volume [μL](2)
BG - ISE - Hct - Glu - Lac 102 188
BG - ISE - Hct - Glu - Lac - COOX 123 211
COOX only 25 87
BG(3) (micro sample) 37 --
BG(3) - COOX (micro sample) 55 --
Table 3-115 Sample volumes

(1) Valid for Hct concentrations between 10% and 75%.
(2) Maximum sample volume that can be aspirated from the container.
(3) Hct is measured in BG and BG-COOX micro sample modes.
Roche Diagnostics
Sample types
Sample types
NOTICE Sample types

r Only use the following sample types:
o Whole blood
o Dialysis solutions
o Aqueous solutions
o Recommended QC material(1)
(1) With approximate physiological ion matrix and buffer capacity.
Roche Diagnostics
Calibrations
Calibrations
Calibrations Time intervals Duration [min]

System calibration every 24 hours 16
1P calibrations every 60 minutes 3
2P calibrations every 12 hours (alternatively 4, 8 or 12 hours) 12
Table 3-116 Calibrations
Roche Diagnostics
Environmental parameters
Temperature/humidity/stability
Instrument
NOTICE Operate the system only within the specified conditions.
o Ambient temperature 15–32 °C
o Ambient air pressure 530–800 mmHg (-100 m to + 2500 m above sea
level)
o Relative humidity 15–90% (not condensed)
Table 3-117
NOTICE Store and transport the instrument only within the specified conditions.
Storage and transportation conditions

o Temperature -20 °C to +50 °C
o Humidity 15–85% (not condensed)
o Shock resistance < 30 g
Table 3-118
Sensor Cartridge
o Temperature: BG, Hct up to 28 days at 37 °C
o Temperature: ISE, Glu up to 28 days at 30 °C
o Temperature: Lac up to 21 days at 30 °C
Table 3-119
Storage conditions in original packaging

o Temperature up to 5 months at 2-8 °C
o Humidity 20–85% (not condensed)
Table 3-120
Stability during operation

o BG - Hct up to 28 days or up to 700 tests
o BG - ISE - Hct up to 28 days or up to 700 tests
o BG - ISE - Hct - Glu up to 28 days or up to 700 tests
o BG - ISE - Hct - Glu - Lac up to 21 days or up to 500 tests
Table 3-121
Roche Diagnostics
Fluid Pack
o Ambient temperature up to 42 days at 15-32 °C
Table 3-122

o Temperature up to 9 months at 15-25 °C
Table 3-123

o cobas b 123 Fluid Pack COOX 200 up to 200 tests or up to 42 days(1)
o cobas b 123 Fluid Pack 200 up to 200 tests or up to 42 days(1)
Table 3-124
(1) All Fluid Packs can be used for up to 42 days. The indicated number of tests will be achieved when a
minimum number of measurements are performed per day.
QC material

Temperature
o COMBITROL PLUS B (Level 1–3) o up to 24 months at 2-8 °C
o cobas b 123 AutoQC Pack o up to 24 months at 2-8 °C
o cobas b 123 AutoCVC Pack o up to 24 months at 2-8 °C
Relative humidity 15–85% (not condensed)
Table 3-125

o COMBITROL PLUS B (Level 1–3) up to 3 months at room temperature (up to 28 °C)
o cobas b 123 AutoQC Pack up to 3 months in the instrument
o cobas b 123 AutoCVC Pack up to 3 months in the instrument
Table 3-126
Roche Diagnostics
Product data
Product data
Electrical data
The power supply supplies the instrument with 12 V DC (10 A).
Mains voltage range: 100–240 V AC (+/- 10%)

Frequency: 50–60 Hz (+/- 5%)
Required power: max. 120 W
Classification (according IEC/ISO)
Protection class: III (external power adaptor is class I)

Overvoltage category: I
Contamination level: 2
Dimensions
Width: 32 cm
Height: 47 cm
Depth: 33 cm
Weight
cobas b 123 POC system (instrument): 20 kg (without Fluid Pack and AutoQC Pack)
24.5 kg (with Fluid Pack and AutoQC Pack)
Acoustic noise level
In normal operating conditions: <60 dB(A)

Printing noise: <65 dB(A)
Alarm signal noise: <80 dB(A)
Roche Diagnostics
Product data
Holding points
Lift and carry the instrument using the 2 slots on each side of the instrument. Use
both hands to lift and carry the instrument.
A Holding points
Figure 3-1 Holding points
Roche Diagnostics
Printer
Printer
Type: Thermal printer

Resolution: 203 dpi (8 dots/mm)
Full graphics: 832 dots/line
Printing speed: Standard measurement report < 10 seconds
Paper width: 113.5 ± 0.5 mm
Paper length: about 45 m
Roche Diagnostics
Hardware version 1 PC: Intel Atom N270 1.6 GHz

Memory: 512 MB RAM
Hard disk: ≥40 GB storage capacity
CompactFlash card: ≥1 GB storage capacity
USB storage device: ≥ Version 2.0
Screen type: LCD technology with touch screen
Format: 10.4 inches
Resolution: 800 x 600 pixel
Compatible SW version: 4.16
Hardware version 2 PC: Intel Atom x5-E3930 1.3 GHz

Memory: 2 GB RAM
Hard disk: ≥32 GB storage capacity
SD memory card: ≥1 GB storage capacity
USB storage device: ≥ Version 2.0
Screen type: LCD technology with touch screen
Format: 10.4 inches
Resolution: 800 x 600 pixel
Compatible SW version: 4.17
u Related topics
o Hardware versions (p. 30)
Roche Diagnostics
Barcode scanner
Barcode scanner
Hardware version 1 Manufacturer: Datalogic

Type: Touch 90 TD1170-90 PS2 hand-held scanner with
integrated decoder
Resolution: 0.127 mm
Reading window: 90 mm
Reading distance(1): up to 18.5 cm
(1) Depending on symbol length, scan angle, printing resolution, contrast and ambient light
Manufacturer: Unitech
Type: MS180 PS2 hand-held scanner with integrated
decoder
Resolution: 0.1 mm
Reading distance (1): up to 5 cm
Manufacturer: Marson
Type: MT9060 PS2 hand-held scanner with integrated
decoder
Resolution: 0.1 mm
Reading distance (1): up to 12 cm
Preprogrammed code types(1): o UPC-A

o UPC-E
o EAN-8
o EAN-13
o EAN-128
o Interleave 2 of 5
o Code 39
o Code 93
o Code 128
(1) Roche default settings applied. Further available barcode types can be programmed in accordance with
the manufacturer’s PS2 scanner Reference Guide. The Reference Guide is available via your Roche
representative on demand.

Type: Touch 90 TD1100 USB hand-held scanner with
integrated decoder
Roche Diagnostics
Barcode scanner
Reading distance(1): Code 39 5 mils: up to 2.5 cm

Code 39 7.5 mils: up to 8.5 cm
Code 39 10 mils: up to 13.5 cm
EAN-13 13 mils: up to 18.5 cm
Preprogrammed code types(1): o UPC-A

o UPC-E
o EAN-8
o EAN-13
o EAN-128
o Interleave 2 of 5
o Code 39
o Code 93
o Code 128
(1) Roche default settings applied. Further available barcode types can be programmed in accordance with
the manufacturer’s PS2 scanner Reference Guide. The Reference Guide is available via your Roche
representative on demand.
Roche Diagnostics

Type: Magellan® 1100i Imaging Scanner with optional holder
Reading speed 1768 digital scan/s.
Reading width (1): 0 to 17.1 cm
(1) Depending on the barcode length and the scanning angle.
Manufacturer: Datalogic
Type: Magellan® 1000i Imaging Scanner with optional holder
Reading speed 1000 digital scan/s.
Reading width(1): 0 to 17.15 cm
(1) Depending on the barcode length and the scanning angle.

Type: Magellan® 1500i Imaging Scanner with holder
Reading width (1): 0 to 30.0 cm
(1) Depending on the printing resolution, barcode length, scanning angle, contrast, and ambient light.
Pre-programmed code types o UPC-A

Pre-programmed code types(1):
o UPC-E
o EAN-8
o EAN-13
o Standard 2 of 5
o Interleave 2 of 5
o Code 39
o Code 128
o Codabar
o MSI Plessey
(1) Further available barcode types can be programmed in accordance with the manufacturer’s Product
Reference Manual.
Roche Diagnostics
cobas b 123 POC system 4 Theoretical foundations
Table of contents
Theoretical foundations 4
This chapter contains background information on how calculated values are derived
and how calibrations are performed on the system. In addition, unit conversion
tables, standard values and reference ranges for measured parameters are provided.

Assigning unit formats to parameters ...............................................................................95
Selecting between pH and H+ unit formats......................................................................96
Parameters and calculations ...............................................................................................97
Conversion table for units.............................................................................................97
Temperature..............................................................................................................97
Standard values and ranges...........................................................................................97
Equations.........................................................................................................................98
cH+ .............................................................................................................................98
cHCO3- ......................................................................................................................98
ctCO2(P) ...................................................................................................................98
FO2Hb .......................................................................................................................98
BE ...............................................................................................................................99
BEecf ...........................................................................................................................99
BB...............................................................................................................................99
SO2 .............................................................................................................................99
SO2(c) ........................................................................................................................99
P50 ........................................................................................................................... 100
ctO2 ......................................................................................................................... 101
ctCO2(B) ................................................................................................................ 101
pHst ......................................................................................................................... 101
cHCO3-st ................................................................................................................ 102
PAO2 ....................................................................................................................... 102
AaDO2 .................................................................................................................... 102
a/AO2 ...................................................................................................................... 103
avDO2 ..................................................................................................................... 103
RI............................................................................................................................. 103
Shunt (Qs/Qt)........................................................................................................ 104
Shunt estimated (Qs/Qtest) .................................................................................. 105
nCa2+ ...................................................................................................................... 105
Roche Diagnostics
4 Theoretical foundations cobas b 123 POC system
Table of contents
AG ........................................................................................................................... 105
pHt .......................................................................................................................... 106
cHt ........................................................................................................................... 106
PCO2t...................................................................................................................... 106
PO2t......................................................................................................................... 106
PAO2t ...................................................................................................................... 106
AaDO2t ................................................................................................................... 107
a/AO2t ..................................................................................................................... 107
RI t ........................................................................................................................... 107
Hct(c)...................................................................................................................... 108
MCHC .................................................................................................................... 108
BO2 ......................................................................................................................... 108
BEact ........................................................................................................................ 108
Osm......................................................................................................................... 109
Osmopt .................................................................................................................... 109
Osmopt Gap............................................................................................................ 109
OER......................................................................................................................... 110
Heart minute volume (Qt) ................................................................................... 110
PF index ................................................................................................................. 110
Lacclearance 1h ......................................................................................................... 111
Bibliography........................................................................................................... 111
Calibration principle......................................................................................................... 113
Oximeter module (optional)............................................................................................ 114
Functional principle.................................................................................................... 114
Reference and critical values............................................................................................ 115
Reference/normal ranges ........................................................................................... 115
Critical ranges.............................................................................................................. 117
Assigning reference and critical ranges .......................................................................... 118
Monitoring reference and critical ranges on measurement reports ........................... 121
Assigning a correlation factor to a parameter ............................................................... 122
Roche Diagnostics
Assigning unit formats to parameters
Assigning unit formats to parameters
p To assign a unit format to parameters
q You can only assign unit formats for parameters that have more than one unit format.
1 Utilities > Configuration > Measurement > Parameter > Units
Figure 4-1 Unit formatting for parameters setup screen
2 In the Set units panel, choose the parameter from the drop-down list. Then, press
the button.
The Set unit for [parameter] dialog box is displayed.
q In the dialog box the left-most unit is the default unit.

The currently selected unit is indicated by a darker color
3 In the dialog box, select your desired units.

4 To set all parameters to their default units, press the Set all to default button.
A dialog box displays informing you that all parameters will be reset to their
default units, and asking you if you wish to proceed.
s
Roche Diagnostics
+
Selecting between pH and H unit formats
Selecting between pH and H+ unit formats
p To select between pH and H+ unit formats
q Switching between pH and H+ unit formats changes reference and critical ranges and QC
rules and consequences, and deactivates correlation factors from the previous unit format.
1 Utilities > Configuration > Measurement > Parameter > pH / H+
Figure 4-2 Selecting pH and H+ unit format screen
2 To select between pH and H+ unit formats, press the and buttons on the
Configure parameter view panel.
s
Roche Diagnostics
Parameters and calculations
Conversion table for units
The system provides an array of useful parameters, which are calculated from the
measurement values of each sample. Refer to the following table for an explanation of
the symbols used in the equations. Unless stated otherwise, all measurement values
that are used in the equations were measured at 37 °C.
Parameter Unit 1 Unit 2 Unit 3 Unit 4

(Default)
ctO2, avDO2, ctCO2 1 vol% = 1 mL/dL = 0.4464 mmol/L
Ca 2+ 1 mmol/L = 4.008 mg/dL

tHb 1 g/dL = 10 g/L = 0.6202 mmol/L
Glucose 1 mmol/L = 18.02 mg/dL
Lactate 1 mmol/L = 9.008 mg/dL
Bilirubin 1 mg/dL = 17.1 μmol/L
Osmolality 1 mOsm/kg = 1 mmol/kg
MCHC 1 g Hb/dL Ery = 0.155 mmol Hb/L Ery
Air pressure (PCO2, PO2) 1 mmHg = 1.3333 mbar = 0.1333 kPa = 39.37x10-3 inch Hg
Table 4-1 Conversion table for units
Temperature
9
T  F  = ---  T  C  + 32
Equation 4-1
5
5
T  C  = ---   T  F  – 32 
Equation 4-2 9
Standard values and ranges
Parameter Standard value Possible range

tHb 15.0 g/dL 1.0–26.0 g/dL
150 g/L 1–260 g/L
9.0 mmol/L 1.0–16.0 mmol/L
FIO2 0.21 0.10–1.00
R (Respiratory quotient) 0.84 0.70–2.00
Patient's temperature 37.0 °C 2.0–44.0 °C
98.6 °F 35.6–111.0 °F
Hb factor 3.0 2.7–3.3
Table 4-2 Standard values and ranges
Roche Diagnostics
Equations
If calculated values exceed their critical ranges, verify the validity of your results
with a medical specialist before making any clinical decisions.
WARNING
q Default units are used for the calculation of the equations.
q Calculated values that require measurement results from arterial blood are only provided
for “arterial” and “capillary” blood types.
q You can find all referenced publications in the bibliography at the end of this section.
cH+
Hydrogen ion concentration[1]

Unit: [nmol/L]
FH+ = 10(9-pH)
Equation 4-3
cHCO3-
Bicarbonate concentration in plasma[1]

Unit: [mmol/L]
cHCO3- = 0.0307 * PCO2 * 10(pH-6.105)
Equation 4-4
ctCO2(P)
Total concentration of CO2 in plasma[1]

Unit: [mmol/L]
ctCO2(P) = cHCO3- + (0.0307 * PCO2)
Equation 4-5
FO2Hb
Fractional oxygen saturation[1]

Unit: [-]
O 2 Hb
FO 2 Hb = --------------
-
100
Equation 4-6
Roche Diagnostics
BE
The base deviation of blood determines the titratable base of the blood. Theoretically,
this is measured by titrating blood with a strong acid or base to a pH = 7.4 with PCO2
= 40 mmHg at 37 °C.[1]
Unit: [mmol/L]
BE = (1 − 0.014 ⋅ tHb) ⋅ [(1.43⋅tHb + 7.7 ) ⋅ (pH − 7.4 ) − 24.8 + cHCO 3 ]

−
Equation 4-7
u BEact (p. 108)
BEecf
The base deviation of extracellular fluid determines the non-respiratory components
of the acid-base balance.[1]
Unit: [mmol/L]
BE ecf = 16.2⋅(pH − 7.4 ) − 24.8 + cHCO 3

−
Equation 4-8
BB
The buffer base is the concentration of buffering anions, which is available in whole
blood, to buffer strong acids and consists mainly of protein anions and bicarbonate.
Of the protein anions, hemoglobin is the most significant.[2]
Unit: [mmol/L]
BB = BE + 41.7 + 0.42 ⋅ tHb

Equation 4-9
SO2
The quantity of oxyhemoglobin in the blood in proportion to the quantity of
hemoglobin in the blood that can bind to oxygen.[1]
Unit: [%]
O 2 Hb
SO 2 = ⋅100
O 2 Hb + HHb
Equation 4-10
SO2(c)
q Measured SO2 has a higher priority than the calculated SO2(c). Calculating SO2(c) requires
pH, PCO2, and PO2 values, and input value, Age (a/f).
The quantity of oxyhemoglobin in the blood in proportion to the quantity of

hemoglobin in the blood that can bind to oxygen.[1]
Roche Diagnostics
Unit: [%][3][4]
Q
SO 2 (c ) = SO ( P O 2 , pH, P 50, a/f, BE) = ⋅ 100
Q +1
Equation 4-11
where
k
k
lgQ = 2.9 ⋅ lgPO 2 + F1 ⋅10 − F 2⋅PO 2 − F3
P 50
lgPO k2 = lgPO 2 + 0.48 ⋅ (pH - 7.4) - lg( ) + 0.0013 ⋅ BE
26.7
Equation 4-12
Adult[3] P50 = 26.7

o F1 = 1.661
o F2 = 0.074
o F3 = 4.172
Fetal[3] P50 = 21.5

o F1 = 1.3632
o F2 = 0.0533
o F3 = 4.113
P50
The PO2 value at which 50% of the hemoglobin is saturated with oxygen. P50 can only
be calculated if measured SO2 is available.
Unit: [mmHg]
P 50 = 26.7⋅10 (lgPO 2 −lgPO 2 )

k
Equation 4-13
where
(lg Q + F3)
k
lg PO 2 =
2 .9
SO 2
Q=
100% − SO 2
Equation 4-14
Adult[3] F3 = 4.172
Fetal[3] F3 = 4.113
Roche Diagnostics
ctO2
Oxygen content is the sum of oxygen bound to hemoglobin as O2Hb and the amount
of oxygen dissolved in the plasma.[1] ctO2 can only be calculated if measured SO2 is
available.
Unit: [vol%]
X
ctO 2 ( PO 2 , SO 2 , tHb) = 1.39 ⋅ ⋅ tHb + 0.00314 ⋅ PO 2
100
Equation 4-15
where
O2Hb present: X = O2Hb
O2Hb not present: X = SO2(c)
u SO2(c) (p. 99)
If PO2 is not available, ctO2 is calculated with PO2 = 90 mmHg.
ctCO2(B)
ctCO2(B) is the sum of the total CO2 in plasma and red blood cells (erythrocyte fluid
= ERY).[5]
Unit: [mmol/L]
ctCO 2 (B) =
tHb
0.000768 ⋅ PCO 2 ⋅ tHb ⋅ (1 + 10(pH ERY − pK ERY ) ) + ctCO 2 (P) ⋅ (1 − )
33.8
Equation 4-16
where
SO 2
pH ERY = 7.19 + 0.77 ⋅ (pH − 7.4) + 0.035 ⋅ (1 − )
100
so 2
(pH ERY − 7.84 − 0.06⋅ )
pK ERY = 6.125 − lg(1 + 10 100
)
Equation 4-17
SO2 or if SO2 not available, see SO2(c) (p. 99).
q Correct calculation of the calculated value is only possible after measuring a whole blood
sample with the sample type setting “blood”.
pHst
Standard pH value of the blood is defined as the pH value of a blood sample which
has been equilibrated at 37 °C with a gas mixture having a PCO2 = 40 mmHg.[3]
Unit: [pH unit]
Roche Diagnostics
pH st = (0.8262 − 0.01296 ⋅ tHb + 0.006942 ⋅ BE) ⋅ lg(0.025 ⋅ PCO 2 ) + pH
Equation 4-18
cHCO3-st
Standard bicarbonate of the blood, defined as the plasma bicarbonate concentration
in blood, which has been equilibrated at 37 °C with a gas mixture having a PCO2 =
40 mmHg.[3]
Unit: [mmol/L]
= 10 (pH st − 6.022 )
−
cHCO3 st
Equation 4-19
PAO2
The alveolar oxygen partial pressure is used to calculate several parameters used for
oxidation and breathing.[6]
Unit: [mmHg]
ª 1 − FIO 2 º
PAO 2 = ( Ptotal − 47)⋅FIO2 − PACO 2 ⋅« FIO2 +
¬ R »¼
Equation 4-20
If the result of the calculation is PAO2 < PO2, then PAO2 is set to equal PO2.
Therefore, PACO2 corresponds to the measured PCO2.
q PAO2 values are only provided for “arterial” or “capillary” blood types.
Ptotal = Baro
R = RQ
u PAO2t (p. 106) for patient temperatures other than 37 °C.
AaDO2
The alveolar arterial oxygen partial pressure gradient (PAO2 - PaO2) is the difference
between the alveolar oxygen partial pressure, as calculated above, and the measured
oxygen partial pressure of arterial blood.[6]
Unit: [mmHg]
AaDO2 = PA O2 - Pa O2
Equation 4-21
PaO2 = PO2
u AaDO2t (p. 107) for patient temperatures other than 37 °C.
q AaDO2 values are only provided for “arterial” or “capillary” blood types.
Roche Diagnostics
a/AO2
Arterial alveolar oxygen partial pressure ratio.[5]

Unit: [%]
PaO 2
a/AO 2 = ⋅100
PAO2
Equation 4-22
PaO2 = PO2
u a/AO2t (p. 107) for patient temperatures other than 37 °C.
avDO2
Arterial venous oxygen tension ratio.[1]

Unit: [vol%]
avDO 2 = ctO 2 ( a ) – ctO 2 ( v )
Equation 4-23
Calculated ctO2(a) and ctO2(v) according to the calculation for ctO2 for arterial and
venous blood.
u ctO2 (p. 101).
Calculating avDO2 requires the following conditions:

o Same patient numbers for both measurements
o 2 consecutive measurements
o Sample type is arterial and mixed venous blood
RI
The respiratory index is calculated as the ratio of the alveolar-arterial oxygen tension
gradient to the arterial oxygen tension.[6]
Unit: [%]
( PAO2 − PaO 2 )
RI = ⋅ 100
PaO 2
Equation 4-24
q RI values are only provided for “arterial” or “capillary” blood types.
PaO2 = PO2
u RI t (p. 107) for patient temperatures other than 37 °C.
Roche Diagnostics
Shunt (Qs/Qt)
The shunt parameter is a measure of the direct mixing of venous blood into the
oxygenated blood circulation. The shunt parameter gives the short circuit volume
relating to the total volume (% - value).[6]
To determine it, 2 independent measurements are needed.
Both measurements have to be carried out with the same patient ID. Define the
patient ID as an input value. To do this, press the following buttons: Utilities
> Configuration > Measurement > Data input > Input values
1. Measurement with the “mixed venous” blood type:
Select the “mixed venous” blood type
2. Measurement with the “arterial” blood type:
Select the “arterial” blood type. The desired value for Qs/Qt is determined.
q You cannot calculate the shunt value with a combination of arterial and venous blood.
You cannot change input values, such as patient ID, after a measurement in order to
calculate the shunt value.
You can measure samples from other patients while you wait for the 2 Qs/Qt partial
measurements.
The maximum time between 2 Qs/Qt partial measurements is 30 minutes.
Additional information Calculating shunt requires the following measurement and calculation values:
o tHb, SO2 (arterial)
o PO2 (arterial)
o PAO2
o ctO2 (arterial)
To obtain these measured and calculated values, select the “arterial” blood type.
Also, calculating shunt requires a ctO2 (mixed venous) value. To calculate this, select
the “mixed venous” blood type.
To select the blood type for a measurement, define blood type as an input value. To
do this, press the following buttons: Utilities > Configuration > Measurement
> Data input > Input values
Unit: [%]
SaO 2
100 ⋅ [1.39 ⋅ tHb ⋅ (1 − ) + (PAO 2 − PaO 2 ) ⋅ 0.00314]
Qs 100
=
Qt SaO 2
[(ctO 2 (a) − ctO 2 (v)) + 1.39 ⋅ tHb ⋅ (1 − ) + (PAO 2 − PaO 2 ) ⋅ 0.00314]
100
Equation 4-25
Qs shunt flow
Qt heart minute volume
Qs/Qt fraction of shunted cardiac output
SaO2 arterial oxygen saturation fraction
avDO2 is used for the calculation instead of ctO2(a) and ctO2(v).

u avDO2 (p. 103)
Roche Diagnostics
Shunt estimated (Qs/Qtest)

To calculate an estimated shunt value, a fixed value of 5.15 vol% (=2.3 mmol/L) is
used for avDO2.[5] To determine this, 1 independent measurement of arterial blood is
required.
o Select “arterial” blood type. The desired value for Qs/Qtest is determined.
Additional information Calculating shunt requires the following measurement and calculation values:
o tHb, SO2 (arterial)
o PO2 (arterial)
o PAO2 (arterial)
Unit: [%]
ܱܵ (ܽ)
100 ή ൤1.39 ή ‫ )ܽ(ܾܪݐ‬ή ൬1 െ ଶ ൰ + ൫ܲ‫ܱܣ‬ଶ (ܽ) െ ܱܲଶ (ܽ)൯ ή 0.00314൨
ܳ௦ 100
(݁‫= )ݐݏ‬
ܳ௧ ܱܵଶ (ܽ)
൤5.15 + 1.39 ή ‫)ܽ(ܾܪݐ‬ ή ൬1 െ ൰ + ൫ܲ‫ܱܣ‬ଶ (ܽ) െ ܱܲଶ (ܽ)൯ ή 0.00314൨
100
Equation 4-26
Qs shunt flow
Qt heart minute volume
Qs/Qt (est) estimated fraction of shunted cardiac output
SaO2 arterial oxygen saturation fraction
(a) arterial measurement value
nCa2+
The ionized calcium value is standardized to pH = 7.40.[7]

Unit: [mmol/L]
nCa 2+ ( pH = 7.4) = Ca 2+ ⋅ 10 F5⋅(pH−7.4)
Equation 4-27
Blood: F5 = 0.22
This equation is valid for pH values between 7.2 and 7.6.
AG
The anion gap is a calculated parameter used to express the difference in
concentration of major cations and anions in the blood sample.[2]
Unit: [mmol/L]
−
AG = Na + + K + - Cl - - cHCO 3
Equation 4-28
Roche Diagnostics
pHt
Corrected pH value for patient temperatures other than 37 °C.[1]
pHt = pH − [0.0147 + 0.0065 ⋅ (pH − 7.4)] ⋅ (t − 37)
Equation 4-29
cHt
Corrected hydrogen ion concentration for patient temperatures other than 37 °C.[1]
Unit: [nmol/L]
t
FHt =10(9− pH )
Equation 4-30
PCO2t
Corrected CO2 value for patient temperatures other than 37 °C.[1]

Unit: [mmHg]
PCO 2 t = PCO 2 ⋅ 100.019⋅( t−37)
Equation 4-31
PO2t
Corrected O2 value for patient temperatures other than 37 °C.[1]

Unit: [mmHg]
ª 5.49⋅10 −11⋅PO 2 3.88 + 0.071º

« −9 3.88 » ⋅( t − 37 )
t «¬ 9.72⋅10 ⋅PO 2 + 2.30 »¼
PO 2 = PO 2 ⋅ 10
Equation 4-32
PAO2t
Corrected alveolar oxygen partial pressure for patient temperatures other than
37 °C.[6]
Unit: [mmHg]
§ 1 − FIO 2 ·º
t
( ) t ª
PAO 2 = Ptotal − PH 2 O t ⋅ FIO 2 − PACO 2 ⋅ « FIO 2 + ¨ ¸»
¬ © R ¹¼
Equation 4-33
where
PAO 2t ≤ PO 2t otherwise PAO 2 t = PO 2t
Roche Diagnostics
Equation 4-34
and
[ 0.0237 − 0.0001 ⋅ ( t − 37 )]⋅ ( t − 37 )

PH 2 O t = 47 ⋅10
Equation 4-35
Ptotal = Baro
R = RQ
AaDO2t
Corrected alveolar oxygen partial pressure for patient temperatures other than
37 °C.[6]
Unit: [mmHg]
AaDO 2 t = PAO 2 t − PaO 2 t
Equation 4-36
PaO2t = PO2t
q AaDO2t values are only provided for “arterial” or “capillary” blood types.
a/AO2t
Corrected arterial alveolar oxygen partial pressure ratio for different patient
temperatures.[6]
Unit: [%]
t
t PaO 2
a/AO2 = t
⋅100
PAO 2
Equation 4-37
RI t
Corrected respiratory index for patient temperatures other than 37 °C.[6]

Unit: [%]
t t
( PAO 2 − PaO 2 )
RI t = t
⋅100
PaO 2
Equation 4-38
PaO2t = PO2t
q RIt values are only provided for “arterial” or “capillary” blood types.
Roche Diagnostics
Hct(c)
Hct as a function of tHb.[8]

Unit: [ - ]
F
Hct(c) = tHb ⋅
100
Equation 4-39
Default value of Hb factor, F = 3.00 (F = 100/MCHC [g/dL])[9]

Input range: 2.70–3.30. This corresponds to an MCHC of 30.3 g/dL to 37 g/dL (=
reference range for adults).[8]
q Only measured tHb is allowed.
MCHC
Mean corpuscular hemoglobin concentration.[8]

Units: [g (Hb)/dL (Ery)]
tHb
MCHC = ⋅ 100
Hct
Equation 4-40
Only displayed as a calculated value if both values are measured.
BO2
Oxygen capacity.[1]
Unit: [vol%]
ª (COHb − MetHb − SulfHb ) º

BO 2 = tHb ⋅ «1 − »¼ ⋅1.39
¬ 100
Equation 4-41
If SulfHb is not measured, SulfHb = 0.
BEact
Base deviation at actual oxygen saturation.[2]
q To calculate BEact, you have to define age as an input value.
Unit: [mmol/L]
BEact = (1 - 0.0143⋅ tHb) ⋅ [(1.63 ⋅ tHb + 9.5) ⋅ (pH − 7.4) − 24.26 + cHCO3− ] −
§ SO ·
− 0.2 ⋅ tHb⋅ ¨1− 2 ¸
© 100 ¹
Roche Diagnostics
Equation 4-42
The calculation takes place with SO2 or, if not available, with SO2(c).
Osm
Osmolality.[10]
Unit: [mOsm/kg]
Equation for blood, plasma, serum:
Osm = 1.86 ⋅ Na + + Glu + Urea + 9

Equation 4-43
Equation for aqueous solution, acetate, bicarbonate:
Osm = 2 ⋅ (Na + + K + ) + 3 ⋅ (Ca 2+ + Mg 2+ ) + Glu + Urea
Equation 4-44
Default parameter values for calculating Osm:
o K+ = 4.3 mmol/L
o Ca2+ = 1.25 mmol/L
o Mg2+ = 0.6 mmol/L
o Glu = 4.5 mmol/L
o Urea = 5 mmol/L
Conditions for calculating Osm:
Na+: If no measured value is available, osmolality is not calculated.

K+: If no measured value is available, the default value is used.
Ca2+: If no measured value is available, the default value is used.
Mg2+: The default value is used.
Urea: The default value is used.
Glu: If no measured value is available, the default value is used.
Osmopt
Osmolatity (optimized).[11]
Unit: [mOsm/kg]
Equation for blood, plasma, serum:
Osmopt = (Na+ + K+ + Cl- + Lac + Glu + HCO3- + Urea(e) + 6.5) * 0.985

Equation 4-45
q Osmopt is only calculated if all measured, calculated and input values are available.
Osmopt Gap
Difference (gap) between measured and calculated osmolality.[11]

Unit: [mOsm/kg]
Roche Diagnostics
ܱ‫݉ݏ‬opt‫ )݁(݉ݏܱ = ݌ܽܩ‬െ ܱ‫݉ݏ‬opt
Equation 4-46
q Osmopt Gap is only calculated if the input value, Osm(e) (measured osmolality with an
osmometer) and the calculated value, Osmopt, are available.
OER
Oxygen extraction ratio.[1]

Unit: [%]
(ctO 2(a) − ctO 2(v) )

OER = ⋅ 100
ctO 2(a)
Equation 4-47
u ctO2 (p. 101)
Calculating OER requires the following conditions:

q Different OER calculations are used, depending on whether measured COOX values are
available or not.
If you have a measured O2Hb value, the X parameter in the ctO2 formula is the O2Hb value.
If you do not have a measured O2Hb value, the X parameter in the ctO2 formula is SO2(c).
Heart minute volume (Qt)
Unit: [vol%][6]
Q t = ctO2 (C) −ctO2(v)

SaO 2
= [(ctO 2 (a) − ctO 2 (v)) + 1.39 ⋅ tHb ⋅ (1 − ) + (PAO2 − PaO 2 ) ⋅ 0.00314]
100
Equation 4-48
SaO2: arterial oxygen saturation fraction

ctO2(a) - ctO2(v) = avDO2
Calculating Qt requires the following conditions:
PF index
Ratio of alveolar oxygen partial pressure to the proportion on inspiratory oxygen[6]

Unit: [mm/Hg]
Roche Diagnostics
PaO
PF index = FIO 2
2
Equation 4-49
PaO2 = PO2
Lacclearance 1h
Lactate Clearance calculates, in percent, the hourly change of measured lactate.[12],

[13]
. It requires 2 independent measurements.
q Both measurements must be carried out with the same patient ID.
Define patient ID as an input value.
q Samples from patients with other patient IDs can be measured between the 2 Qs/Qt partial
measurements.
When calculating lactate clearance, either the current or the previous lactate value has to
be greater than 4 mmol/L.
A minimum of 2 hours, but no more than 8 hours, has to pass between 2 lactate partial
measurements.
Unit: [%]
Lac hist – Lac h

LacClear = -------------------------------- ⋅ 100 ⋅ ---
Lac hist Δ
Equation 4-50
Lac is the latest measured lactate value

Lachist is the historical lactate value
h h=1
Δ is the time interval between the lactate measurements
Bibliography
[1] Clinical and Laboratory Standards Institute, Blood gas and pH related measurements,
CLSI document C46-A2; Approved Guideline (2001), Vol. 29 No. 8
[2] Müller-Plathe, Oswald: Säure-Basen-Haushalt und Blutgase/ Breuer, Büttner,

Stamm, Stuttgart; New York: Georg Thieme Verlag, 1982.
[3] Marsoner, Hermann J.: Medequip 82 - Geräte, Instrumente, Materialien,

Diagnostica, Einrichtungen für die Medizin- Jahrgang 1982, Heft 2, Seite 37–42
[4] Marsoner, H. J.; Harnoncourt, K.: The calculation of the oxygen saturation as
function of pO2, pH, temperature and base deviation; Anaesthesist 25, 345–348
(1976)
[5] Siggaard-Anderson. O.; Wimberley. P. D.; Fogh-Anderson. N.; Gøthgen. I. H.:

Measured and derived quantities with modern pH and blood gas equipment:
calculation algorithms with 54 equations; Scand. J. Clin. Lab. Invest. 1988, 48. Suppl.
189: 7–15
Roche Diagnostics
[6] National Committee on Clinical Laboratory Standards, Defintions of Quantities and

Conventions Related to Blood pH and Gas Analysis, NCCLS Document C12-A;
Approved Standard (1994), Vol. 14 No. 11.
[7] Thode, J. Fogh-Andersen, N. Wimberley, P.D. Moller Sorensen, A. Siggaard-

Andersen, O.: Relation between pH and ionized calcium in vitro and in vivo man.
Scand. J. Clin. Lab. Invest., 43. Suppl. 165, 79–82, 1983
[8] Thomas, Lothar: Labor und Diagnose: Indikation und Bewertung von
Laborbefunden für die medizinische Diagnostik; 7. Auflage, Frankfurt am Main: TH-
Books- Verl.- Ges. 2008, S. 677 f.
[9] Despopoulos, Agamemmon; Silbernagel, Stefan: Color Atlas of Physiology, Georg

Thieme Verlag Stuttgart, New York 1991, 4th edition, p. 60
[10] Burtis, Carl A,; Ashwood, Edward R.: Tietz Textbook of Clinical Chemistry, 4th
edition, W.B. Saunders Company, 2006; p. 992
[11] Fazekas, A. S.; Funk, G.-Ch.; Klobassa, D. S.; Rüther, H., Ziegler, I., Zander, R.,
Semmelrock, H.-J.: Evaluation of 36 formulas for calculating plasma osmolality;
Intensive Care Med (2013), 39: 302–308
[12] Alan E. Jones; Nathan I. Shapiro; Stephen Trzeciak; Ryan C, Arnold; Heather A.
Claremont; Jeffrey A. Kline: Lactate clearance vs central venous oxygen saturation as
goals of early sepsis therapy. a randomized clinical trial; JAMA, February 24. 2010,
Vol. 303, No. 8, 739–746
[13] H. Bryant Nguyen; Manisha Loomba; James J. Yang; Gordon Jacobsen; Kant Shah;
Ronny M. Otero; Arturo Suarez; Hemal Parekh; Anja Jaehne; Emanuel P. Rivers:
Early lactate clearance is associated with biomarkers of inflammation, coagulation,
apoptosis, organ dysfunction and mortality in severe sepsis and septic shock; Journal
of Inflammation 2010. 7:6
Roche Diagnostics
Calibration principle
Calibration principle
u Calibration (p. 221)
The Fluid Pack contains 3 stable aqueous solutions to calibrate the system’s
parameters.
PO2 sensor Calibrated using ambient air, corresponding to the oxygen concentration in the
standby solution, and a zero point solution (CAL 2 solution). The oxygen
concentration in the standby solution is calibrated hourly.
PCO2, ISE and pH sensors ISE, pH and PCO2 parameters are calibrated using CAL 2 and standby solutions.
These solutions contain specific electrolyte concentrations, and acidic or basic
components of a pH buffer system. PCO2 concentration is kept stable because the
calibration solutions in the Fluid Pack are sealed.
Hct Calibrated using conductivity measurements based on an electronic reference point,

and the standby solution, which has a high conductivity.
Glu/Lac sensors Three calibration points are used from CAL 1, CAL 2, and standby solutions.
Oximeter module (tHb, SO2, Hb Calibrated using a wavelength calibration of the polychromator and a calibration of
derivatives, and bilirubin) the cuvette layer thickness.
Polychromator calibration: The known intensity maxima of the spectral light source
are used as a reference to calibrate the measured signal from the module.
Cuvette layer thickness: The measured absorption of a dye in the CAL 2 solution is
used to calibrate the cuvette layer thickness.
Roche Diagnostics
Oximeter module (optional)
Oximeter module (optional)
This module is included in the cobas b 123 <3> POC system and
cobas b 123 <4> POC system variants.
The oximeter module is an optical sensor module for determining total hemoglobin
(tHb), hemoglobin derivatives oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb),
carboxyhemoglobin (COHb), methemoglobin (MetHb), and neonatal bilirubin
(Bili).
Functional principle
Hemoglobin derivatives and bilirubin are determined spectrophotometrically based

on the Lambert-Beer law.
* C * d
where,
A() Absorption value, A, at each wavelength, 

() Absorption coefficient for individual components, at each wavelength 
C Concentration value of the component
d Cuvette layer thickness
The basic components of the optical system are:

o Light source (LED)
o Hemolyzer
o Cuvette
o Polychromator
Emitted light from a white light LED is guided to the cuvette. In the cuvette, the light
is partially absorbed by the sample and partially allowed to pass through. The light
that has passed through the cuvette is guided through a light guide to the
polychromator, where it is divided and mapped onto the surface of a photosensitive
receiver (CCD). An electric signal in the photosensitive receiver is generated, which is
used to calculate the absorption and the parameter’s concentrations.
Preanalytical issues can affect the amount of light absorbed by the sample, and thus
influence your results. To avoid these issues, follow appropriate sample collection
procedures.
u Sample collection (p. 139)
Measured bilirubin concentrations from whole blood samples are converted to

plasma concentrations at specific hematocrit levels. Hematocrit levels are determined
from the amount of total hemoglobin.
Samples are hemolyzed inside the cuvette to minimize light scattering from red blood
cells. Hemolysis applies a strong ultrasonic field to samples, in order to rupture red
blood cells and release hemoglobin.
Some limitations also apply for the optical determination of hemoglobin derivatives.
All substances, other than hemoglobin derivatives that absorb or scatter light affect
results. Some examples of these substances are diagnostic or therapeutic dyes, such as
cardio green and methylene blue, and high concentrations of fatty emulsions, such as
Liposyn.
Roche Diagnostics
Reference and critical values
The results of laboratory tests have little practical utility until clinical studies have
ascribed various states of health and disease to intervals of values(1).
Reference intervals are useful because they attempt to describe the typical results
found in a defined population of apparently healthy people. Different methods may
yield different values, depending on calibration and other technical considerations.
Hence, different reference intervals and results may be obtained in different
laboratories. However, reference ranges may need to be adapted for specific patient
groups, whose physiological data are known to differ from the healthy population.
Reference intervals, although useful as a guideline for clinicians, should not be used
as absolute indicators of health and disease (2).
The reference intervals presented in this chapter are for general information
purposes only. Individual laboratories should generate their own set of reference
intervals.
WARNING
Be sure to consider the QC and physiological ranges.
Reference/normal ranges
Parameter Normal range Sample matrix Unit Displayed/printed Source

default range (1)
pH 7.35–7.45 Whole blood arterial 7.350–7.450 Tietz Textbook of Clinical
Chemistry and Molecular
Diagnostics, 5th edition 2012, p.
2162
PO2 83–108 Whole blood arterial mmHg 83.0–108.0 Tietz Textbook of Clinical
2162
PCO2 32–45 (female adult) Whole blood, mmHg 32–48 (all)(2) Tietz Textbook of Clinical
35–48 (male adult) arterial heparin Chemistry and Molecular
32–45 (female)
35–48 (male) 2137
Na+ 136–145 Serum, plasma mmol/L 136.0–145.0 Tietz Textbook of Clinical
2168
K+ 3.5–5.1 Serum mmol/L 3.50–5.10 Tietz Textbook of Clinical
2164
Clˉ 98–107 Serum, plasma mmol/L 98.0–107.0 Tietz Textbook of Clinical
2139
Table 4-3 Reference/normal ranges
(1) Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th Edition 2006, p. 2252
(2) See Chapter 16 of “Tietz' Textbook of Clinical Chemistry and Molecular Diagnostics”. 4th Edition 2006
Roche Diagnostics
Parameter Normal range Sample matrix Unit Displayed/printed Source

default range (1)
Ca2+ 1.15–1.33 Serum, plasma mmol/L 1.150–1.330 Tietz Textbook of Clinical

heparin Chemistry and Molecular
2137
Hct 36–48 (Caucasian female) Whole blood, % 36–53 (all)(3) Lothar Thomas, Labor und
40–53 (Caucasian male) Capillary blood Diagnose, 8. Auflage, p. 840
36–48 (female)
40–53 (male)
tHb 11.5–16.0 (female adult) Capillary blood g/dL 11.5–17.8 (all)(2) Lothar Thomas, Labor und
13.5–17.8 (male adult) Diagnose, 8. Auflage, p. 827
11.5–16.0 (female)
13.5–17.8 (male)
SO2/O2 94–98 Whole blood arterial % 94.0–98.0 Tietz Textbook of Clinical
2162
O2Hb 94.0–98.0 Arterial blood % 94.0–98.0 Lothar Thomas, Labor und
Diagnose, 8. Auflage, p. 535
HHb <3 % 0.0–2.9 Kenneth A. Wyka, Paul J.
Mathews, John Rutkowski:
Foundations of respiratory care, p.
153
COHb ≤3 nonsmoker Whole blood % 0.0–3.0(4) Lothar Thomas, Labor und
heparin Diagnose, 8. Auflage, p. 848
MetHb 0.04–1.52 Whole blood % 0.0–1.5(5) Tietz Textbook of Clinical
heparin Chemistry and Molecular
2160
Bili 2.0–6.0 (0–1 d full term) Serum mg/dL 3.0–10.0 (all)(6) Tietz Textbook of Clinical
6.0–10.0 (1–2 d full term) Chemistry and Molecular
3.0–10.0
4.0–8.0 (3–5 d full term) Diagnostics, 5th edition 2012, p.
(newborn)(6) 2136
6.0–10.0 (2nd day)
4.0–8.0 ( 1 year)
Glu 4.1–5.6 Serum mmol/L 4.1–5.6 Tietz Textbook of Clinical
2149
Lac <1.8 Arterial whole blood mmol/L 1.0–1.8 Lothar Thomas, Labor und
plasma, bed rest Diagnose, 8. Auflage, p. 336
Table 4-3 Reference/normal ranges
(1) By default, the reference/normal ranges are implemented into the instrument software for unspecified: gender, age and sample type. All exceptions
to this general approach are clearly stated. Note that the instrument software does not allow a reference range beyond the specified measuring range.
(2) Refers to the lower limit for females to the upper limit of males.
(3) Refers to the lower limit for Caucasian females to the upper limit of Caucasian males.
(4) Upper limit refers to nonsmokers.
(5) Default value rounded to one tenth place value.
(6) The proposed default reference range for newborns (3.0 - 10.0) mg/dL refers to the lower level of the specified bilirubin measuring range to the upper
level for 1-2 days old full term patients. This lower limit is truncated due to the specified bilirubin measuring range. The same default reference range
for newborn is applied to unspecified ages (all).
Roche Diagnostics
Critical ranges
Normal values depend, among other factors, on the patient, age, gender, lifestyle
habits (e.g. smoking), underlying disease (e.g. asthma), and therapy (e.g. state after an
infusion). This especially applies to critical ranges, as these are based on the normal
values. Therefore, critical ranges can only be approximated and need special
attention if used for therapy decision. By default, critical values are not contained in
the default setting. Laboratories have to adjust critical ranges to fulfill their own
requirements.
u To edit a reference or critical range for a parameter (p. 119)
Roche Diagnostics
Assigning reference and critical ranges
q Default reference and critical ranges are defined on the instrument during installation.
However, individual laboratories should generate their own set of reference and critical
ranges.
p To add a reference or critical range for a parameter

1 Utilities > Configuration > Measurement > Parameter > Ranges
Figure 4-3 Reference/critical ranges setup screen
2 To select a parameter, press the and buttons at the top of the

Set reference/critical ranges panel.
3 To add a reference or critical range for this parameter, press the New button.
A dialog box appears on the screen.
Figure 4-4 Adding reference/critical ranges screen
4 In the upper panel of the screen, press the and buttons to select which
input values you want your new reference or critical value to be valid for.
5 To enter your new reference or critical ranges, press the button in the bottom
panel of the screen. Enter your new reference and/or critical ranges using the
numeric keyboard box that appears on the screen.
6 To apply your new reference or critical range, press the OK button.
s
Roche Diagnostics
p To edit a reference or critical range for a parameter


3 To edit a reference or critical range for this parameter, select the reference or
critical range you want to edit.
o To set the reference and critical ranges for a parameter to its default values,
press the Default button.
or,
o To set the reference and critical ranges for a parameter to another value, press
the Edit button.
Figure 4-6 Editing reference/critical ranges screen
4 To edit the reference or critical range, press the button in the bottom panel of
the screen. Enter your new reference or critical ranges using the numeric
keyboard box that appears on the screen.
5 To apply your new reference or critical range, press the OK button.
s
Roche Diagnostics
p To delete reference and critical ranges for a parameter


Set reference/critical ranges panel
3 To delete all reference and critical ranges for this parameter, press the Delete
button.
s
Roche Diagnostics
Monitoring reference and critical ranges on measurement reports
Monitoring reference and critical ranges on measurement

reports
p To activate reference and critical ranges monitoring on measurement

reports

3 To activate this feature, make sure that the Range check button is checked and
highlighted. If the Range check button is not checked and highlighted, press it.
4 Follow this procedure for your desired parameters.
s
Roche Diagnostics
Assigning a correlation factor to a parameter
Incorrect patient results due to incorrect correlation factors

Correlation factors allow you to adapt your results to account for technical or laboratory-
WARNING specific factors that may affect the accuracy of your results. However, applying incorrect
correlation factors may lead to inaccurate results, which may endanger patient lives.
r If you use correlation factors to adapt your results to another analytical instrument or
method, you are responsible to ensure that these values are valid.
u Correlation to other methods (p. 74)
r Verify the behavior of the analytical instrument and/or the accuracy of the analytical
method that you are using as a reference before performing comparative
measurements.
q Assigning a correlation factor to a parameter may shift measurement results that would be
outside of the measuring range to be inside the measuring range.
Roche does not guarantee measurement results for which correlation factors have been
assigned to parameters.
Correlation factors are used to align results for a parameter between different
analytical systems or methods.
p To add a correlation factor to a parameter

1 Utilities > Configuration > Measurement > Correlations
Figure 4-9 Correlations setup screen
Roche Diagnostics
2 To add a correlation factor to a parameter, press the New button.

Figure 4-10 Adding correlation factors screen
3 In the upper panel of the screen, press the and buttons to select which
parameter you want to add a correlation factor to, and which sample type you
want your new correlation factor to be valid for.
4 To add the offset and/or slope for a parameter, press the button in the bottom
panel of the screen. Enter the offset and/or slope using the numeric keyboard box
that appears on the screen.
5 To apply your new correlation factor, press the OK button.
s
p To edit a correlation factor to a parameter

2 To edit a correlation factor, use the drop-down list to choose which correlation
factors that you want to edit.
o To set a correlation factor for a parameter to its default value, press the
Default button.
or,
o To set a correlation factor for a parameter to another value, press the Edit
button.
Roche Diagnostics
Figure 4-12 Editing correlation factors screen
3 To edit this correlation factor, press the button in the bottom panel of the
screen. Enter your new offset and/or slope using the numeric keyboard box that
appears on the screen.
4 To apply your new correlation factor, press the OK button.
s
p To delete a correlation factor to a parameter

2 In the Set correlation factors panel, use the drop-down list to choose which
correlation factors that you want to delete. Then, press the Delete button.
s
Roche Diagnostics
Operation
5 Installation and put out of operation ............................................................................................ 127

6 Measurement.................................................................................................................................. 137
7 Quality control ............................................................................................................................... 179
8 Calibration ..................................................................................................................................... 221
9 Calibration verification control ..................................................................................................... 233
10 Software functions.......................................................................................................................... 245
cobas b 123 POC system 5 Installation and put out of operation
Table of contents
Installation and put out of operation 5
This chapter describes how to install the instrument, and put the instrument out of
operation.

Installation.......................................................................................................................... 129
Location........................................................................................................................ 129
Installing the instrument.................................................................................................. 131
Put out of operation .......................................................................................................... 134
For less than 24 hours................................................................................................. 134
For more than 24 hours.............................................................................................. 134
Putting the instrument out of operation............................................................ 135
Preparing the instrument for transportation .................................................... 136
Roche Diagnostics
5 Installation and put out of operation cobas b 123 POC system
Table of contents
Roche Diagnostics
Installation
Installation
Location
q Never set up the instrument in the immediate vicinity of patients. Maintain a safety
distance of 1.5 meters (5 feet).
NOTICE Instrument location

r To ensure proper and trouble-free operation, place the instrument in a level location
that is not exposed to direct sunlight.
When installing an instrument that was stored in a cool room or was transported
at low temperatures, condensation may have formed and could have caused
disturbances to the instrument. The instrument has to acclimatized at room
CAUTION
temperature for at least 1 hour before starting operation.
The following conditions have to be met:

o Elevation: -100–2500 m
Ambient air pressure: 530–800 mmHg (70.66 kPa–106.66 kPa)
o Ambient temperature: 15–32°C
o Avoid direct sunlight, vibration, and strong electromagnetic fields (electric
motors, transformers, X-ray equipment, cellular phones, etc.)
o A stable, horizontal working surface (max. 1° angle with installed consumables)
NOTICE Install the instrument only on a stable horizontal surface.

o Relative humidity: 15–90% (non-condensing)
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 Correct voltage: 100–240 VAC (± 10%), 50–60 Hz (± 5%)
After the system has been set up at a location that meets these conditions, carry out
the following steps to prepare the instrument for operation:
o Check the instrument and its accessories for completeness and potential damage.
Verify that the shipment is complete by comparing components with the shipping
order.
If anything is missing, inform your Roche representative immediately.
Roche Diagnostics
Installation
o If the delivery has suffered damage despite careful packing, inform the
transportation company immediately. Retain the packing material and products
as evidence for the damage claim.
NOTICE Inserting damaged consumables may damage the system

If damaged consumables are inserted into the system, locations where consumables
come into contact with the system, such as the measuring chamber module, may
become damaged.
r Before inserting consumables into the system for the first time, check for possible
damage during transportation. If a consumable shows evidence of damage, do not
insert it into the system.
Roche Diagnostics
Installing the instrument

r You must perform a QC measurement on 3 levels after installing the instrument.
WARNING
p To install the instrument

1 Connect the barcode scanner and, if necessary, the network connection to their
corresponding interfaces on the back of the instrument.
A B
A Barcode scanner interface

B Network connection interface: Ethernet (RJ 45)
Figure 5-1 Barcode scanner and network connection interface locations:

Hardware version 1
A A B
A USB interface
B Network connection interface: Ethernet (RJ 45)
Figure 5-2 Barcode scanner and network connection interface locations:

Hardware version 2
q Do not hotplug the Barcode scanner. It will not be recognized when the instrument is
already running and the PS/2 port is electrically not specified for hot-plugging.
Roche Diagnostics
2 Connect the power supply to the instrument, and then connect it to the power
supply network.
A Power supply interface
Figure 5-3 Power supply interface location: Hardware version 1
A Power supply interface
Figure 5-4 Power supply interface location: Hardware version 2
3 To turn on the instrument, press the on/off button.
A On/off button
Figure 5-5 On/off button location
Roche Diagnostics
After the instrument has finished loading, the installation wizard appears on the
screen.
Figure 5-6 Installation wizard
4 Follow the instructions on the screen.

u To change the Sensor Cartridge (p. 303)
u To change the Fluid Pack (p. 304)
u To change the AutoQC Pack (p. 305)
u To change the printer paper (p. 306)
q Complete all installation steps in their correct order.

If the installation wizard fails, press the following buttons to start the installation wizard
again: Utilities > Installation
5 Perform QC measurements on 3 levels.

u Quality control (p. 179)
s
Roche Diagnostics
Put out of operation
For less than 24 hours
If the instrument is not needed for less than 24 hours, switch it off by pressing the
following buttons: Utilities > Switch off. Follow the instructions on the screen.
Instrument is off for more than 1 hour

r Perform a system calibration and QC measurements on 3 levels when you turn the
WARNING instrument on again.
If the instrument is off for less than 1 hour, perform a 2P calibration when you turn
the instrument on again.
q Do not use previously installed Fluid Packs and Sensor Cartridges that have been outside
of an instrument for more than 24 hours.
Do not use previously installed AutoQC Packs that have been outside of an instrument for
more than 7 days.
Do not use previously installed AutoQC Packs, Fluid Packs and Sensor Cartridges that
have exceeded the following cumulative offboard times:
o AutoQC Packs: 7 days
o Fluid Packs: 40 days
o Sensor Cartridges: 10 days
q To disconnect the instrument from the power supply, the power supply has to be
disconnected from the power socket.
For more than 24 hours
If the instrument is not needed for more than 24 hours, put the instrument out of
operation.
Roche Diagnostics
Putting the instrument out of operation
p To put the instrument out of operation

Infection due to contact with the Fluid Pack and the Sensor Cartridge
The Fluid Pack and the Sensor Cartridge may contain materials of human origin. Contact
WARNING with materials of human origin is potentially biohazardous and may result in infection.
r Follow standard laboratory practices.
r Prevent direct contact by wearing appropriate personal protective equipment, such as:
o Lab gloves
o Lab coat
o Eye protection
physician.
1 Utilities > Put out of operation

q Complete all installation steps in their correct order.
q Do not use previously installed Fluid Packs and Sensor Cartridges that have been
outside of an instrument for more than 24 hours.
Do not use previously installed AutoQC Packs that have been outside of an instrument
for more than 7 days.
Do not use previously installed AutoQC Packs, Fluid Packs and Sensor Cartridges that
have exceeded the following cumulative offboard times:
o AutoQC Packs: 7 days
o Fluid Packs: 40 days
o Sensor Cartridges: 10 days
u To change the Sensor Cartridge (p. 303)

u To change the Fluid Pack (p. 304)
u To change the AutoQC Pack (p. 305)
u To change the printer paper (p. 306)
3 To turn off the instrument, press the Switch off button.
q To disconnect the instrument from the power supply, the power supply has to be
disconnected from the power socket.
4 Immediately after putting the instrument out of operation, disinfect the

instrument.
u Disinfection procedures (p. 299)
s
Roche Diagnostics
Preparing the instrument for transportation
p To prepare the instrument for transportation

1 Remove the printer paper from the printer.
2 Remove the USB storage device.
3 Disconnect the barcode scanner and the network connection on the rear panel of
the instrument.
4 Disconnect the power supply from the instrument.
s
Roche Diagnostics
cobas b 123 POC system 6 Measurement
Table of contents
Measurement 6
This chapter describes how to collect and handle samples, perform measurements
and configure measurement settings.

Preanalytics ........................................................................................................................ 139
Sample collection ........................................................................................................ 139
Whole blood .......................................................................................................... 139
Anticoagulants ...................................................................................................... 140
Sample collection, specifically for tHb, SO2 and Hct measurements ............ 140
Sample collection, specifically for glucose and lactate measurements .......... 140
Sample collection, specifically for bilirubin measurements............................ 141
Sample collection, specifically for dialysis solution measurement................. 141
Sample collection containers ..................................................................................... 141
Syringes .................................................................................................................. 142
Capillary tubes....................................................................................................... 142
Roche MICROSAMPLER PROTECT................................................................ 142
Sample collection container accessories ............................................................ 142
Sample handling.......................................................................................................... 143
Whole blood .......................................................................................................... 143
Dialysis solution .......................................................................................................... 144
Interferences....................................................................................................................... 145
Substances without effect on BG, pH, ISE, Glu, Lac and Hct ............................... 145
Substances without effect on tHb, SO2, Hb derivatives and bilirubin ................. 147
Substances with effect on BG, pH, ISE, Glu, Lac and Hct ..................................... 148
Substances with effect on tHb, SO2, bilirubin and Hb derivatives ....................... 149
Limitations of clinical analysis......................................................................................... 152
General information ................................................................................................... 152
Plausibility check for neonatal bilirubin measurements........................................ 152
Configuring measurement input values......................................................................... 154
Configuring the measurement results screen................................................................ 156
Configuring the parameter selection field ..................................................................... 157
Creating user-defined parameter groups................................................................. 158
Performing a measurement.............................................................................................. 160
Measurement modes......................................................................................................... 169
Roche Diagnostics
6 Measurement cobas b 123 POC system
Table of contents
Entering measurement input values ............................................................................... 170

Measurement results and reports.................................................................................... 173
Measuring database........................................................................................................... 175
Acid base maps .................................................................................................................. 176
Patient trend diagrams...................................................................................................... 177
Roche Diagnostics
Preanalytics
Preanalytics
Sample collection
Inappropriate collecting and handling of samples of human origin may result in

infection
WARNING Inappropriate collecting and/or handling samples of human origin may lead to the
transmission of blood or urine borne pathogens.

r Wear appropriate personal protective equipment, such as laboratory clothing,
protective gloves, safety glasses, face masks, and safety visors, to prevent direct
contact.
o Lab gloves
o Lab coat
o Eye protection
r If a sample of human origin is spilled, wipe it up immediately and apply a disinfectant.
r If a sample of human origin comes into contact with your skin, wash the affected area
immediately with soap and water and apply a disinfectant. Consult a physician.
u Clinical and Laboratory Standards Institute. Protection of laboratory workers from

occupationally acquired infections; CLSI document M29-A4; Approved Guidelines
(2014), Vol. 34, No. 8
Whole blood
NOTICE Incorrect patient results due to inappropriate sample collection

Squeezing the puncture site adds tissue fluid to the blood sample and may lead to the
premature onset of clotting despite sufficient heparinization of the sample collection
containers. This may lead to errors and discrepancies in the measurement values.
r Do not squeeze the puncture site before collecting your sample.
r Use the correct sample container for your measurement. Roche recommends using the
Roche MICROSAMPLER PROTECT for blood collection.
Incorrect tHb and bilirubin results due to inappropriate sample handling

tHb and bilirubin concentrations in whole blood samples are sensitive to light. Light
WARNING absorption in whole blood samples may lead to incorrect results, which may endanger
patient lives.
r Immediately measure your whole blood sample after collecting it.
r If you cannot measure your whole blood sample immediately after collecting it, wrap
aluminum foil around your sample collection container.
Roche Diagnostics
Preanalytics
Incorrect calcium results due to inappropriate sample handling

Exposing samples for measuring ionized calcium values to ambient air reduce the amount
WARNING of ionized calcium. This may lead to incorrect ionized calcium results, which may endanger
patient lives.
r Immediately measure your sample after collecting it.
r If you cannot measure your sample immediately after collecting it, do not expose it to
ambient air.
Deviations in measurement results

Measuring hemolyzed blood samples may lead to deviations in measurement results.
WARNING r After you measure a hemolyzed blood sample, perform a 2P calibration.
u Clinical and Laboratory Standards Institute. Procedures for the collection of arterial
blood specimens; CLSI document H11-A4; Approved Standard (2004), Vol. 24, No. 28
Localized hemolysis is possible when collecting blood from regions that have been
compressed. This can vary a patient’s potassium value by up to 20% from its normal
state. Avoid compressing sample collection sites before drawing blood from a patient.
Risk of incorrect results due to air in the sample

Air within blood samples may falsify measurement values.
WARNING r To avoid incorrect patient results, perform measurements on samples as soon as you
have collected your sample.
Metabolite measurements are only possible in samples with an approximate

physiological ion background and pH value, and an average physiological buffer
capacity of the sample.
Anticoagulants
NOTICE Permitted anticoagulants

r Heparin salts are the only permitted anticoagulants for analyses with the
cobas b 123 POC system. Other anticoagulants, such as EDTA, citrate, oxalates,
fluorides and ammonia-containing anticoagulants have a significant effect on the
blood pH value and other parameters and cannot be used.
Sample collection, specifically for tHb, SO2 and Hct measurements

Whole blood samples have to be thoroughly mixed immediately before measuring in
order to have an even distribution of red blood cells and plasma.
To ensure optimum mixing, roll the syringe in your hands, invert and roll it again.
Repeat this for 30 seconds. If there are sedimented red blood cells in the syringe,
repeat the mixing procedure for 1-2 minutes.
Sample collection, specifically for glucose and lactate measurements
Glucose Patient preparation: 12 hour abstinence from food for fasting blood glucose.
Optimum postprandial blood draw 1 hour after eating.
Blood samples should be analyzed immediately after they are collected, and no longer
than 30 minutes after collection. Blood samples can metabolize quickly and cause a
decrease in glucose concentration within a few minutes.
Roche Diagnostics
Preanalytics
Lactate Patient preparation: Draw after at least 2 hours of physical rest. Small amounts of
physical exertion can cause an increase in lactate concentration.
Blood samples should be analyzed immediately after they are collected, and no longer
than 15 minutes after collection. Blood samples can metabolize quickly and cause an
increase in lactate concentration within a few minutes.
Significant arteriovenous differences exist depending on forearm activity and the
oxygenation of the forearm musculature. Deproteinize samples using ice-cold
perchloric acid immediately after they are collected. When using glycolytic inhibitors,
you can work with heparin blood without deproteinization. These samples are stable
for up to 2 hours after its collection.
Sample collection, specifically for bilirubin measurements
Bilirubin sample collection

r Treat whole blood samples as light-sensitive samples:
WARNING o Protect sample containers from light during transport.
o Avoid leaving sample containers in direct sunlight
r Samples should be analyzed immediately after collection.
r Switch off phototherapy light before and during sampling from neonatal patients.
Sample collection, specifically for dialysis solution measurement
Fresh dialysis solution sample collection

r Samples from the fresh dialysis solution may only be taken with an untreated syringe
WARNING free from coagulant inhibitors.
Sample collection containers
Sample collection containers

r Use only Roche sample collection containers.
WARNING
q Roche recommends that you use its sample collection containers.
Roche Diagnostics
Preanalytics
Syringes
If you use another manufacturer’s product with liquid heparin as a clot inhibitor,
sample collection containers should not be larger than required for the blood volume.
This minimizes the effect of the clot inhibitor on blood thinning. Plastic syringes are
normally used, 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 high
PO2 values are expected, the sample should be analyzed as quickly as possible after its
collection.
NOTICE Using non-heparinized syringes or syringes with liquid heparin may lead to
inaccurate patient results
Non-heparinized syringes and syringes filled with liquid heparin, whose volume exceeds
the sample volume, does not prevent blood clotting in the syringe. Blood clots compromise
the integrity of the blood sample, which may lead to inaccurate patient results.
r Use syringes containing balanced heparin salts. Roche recommends using the
Roche MICROSAMPLER PROTECT for blood collection
Capillary tubes
Microhematocrit capillary tubes or capillary tubes with ceramic caps should not be
used because they can damage the fill port of the instrument.
To prevent damage to your instrument, Roche recommends using
Roche MICROSAMPLER PROTECT for blood collection. If you use glass capillary
tubes from other manufacturers, ensure that they have heat-polished ends.
When using stirring rods offered by some manufacturers, remove these rods before
inserting the sample to avoid clogging the sample path of the system.
Roche MICROSAMPLER PROTECT

To make arterial sample collection easier and provide more comfort for the patient,
the Roche MICROSAMPLER PROTECT(1) 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
collection.
Sample collection container accessories
NOTICE Preventing clogging of the sample path during measurement

To prevent clogging of the sample path during measurement of critical blood (for example,
when sampling blood of newborns from earlobes or heels).
r The use of the Clot Catcher is recommended.
Clot Catcher The Clot Catcher, which is placed on top of a capillary or

Roche MICROSAMPLER PROTECT, prevents blood clots and tissue particles from
entering the cobas b 123 POC system.
The Clot Catcher is only suitable for measurements in capillary mode.
(1) is a trademark of Roche
Roche Diagnostics
Preanalytics
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 123 POC system.
The Clot Catcher PRO is only suitable for measurements in capillary mode.
q For more information, refer to the accompanying package inserts for the Clot Catcher and
Clot Catcher PRO.
Sample handling
Whole blood
Withdraw whole blood samples using heparinized syringes, capillaries, or the
Roche MICROSAMPLER PROTECT and analyze them as soon after their collection
as possible. Remove air bubbles from the sample collection container immediately
after collecting the sample.
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
gently rotating. Properly label the samples, following the standard documentation
procedure.
Despite following correct sample collection procedures, errors can still arise in the
blood gas analysis:
o Insufficient mixing of the sample after its collection and before its measurement
o Ambient air contamination caused by air bubbles that were not removed after
sample collection
o Metabolic changes in the sample
Failure to measure samples for tHb, SO2 and Hct parameters immediately after
collecting the sample in a capillary may lead to incorrect patient results
WARNING Failure to measure samples for tHb, SO2 and Hct values, which were collected in
capillaries, immediately after collecting the sample may lead to incorrect patient results,
which may endanger patient lives.
r When measuring samples for tHb, SO2 and Hct values, which were collected in
capillaries, perform the measurement immediately after collecting the sample.
Glass sample container o Samples collected in glass sample containers can be kept up to 15 minutes at room
temperature.
o If you are not able to measure these samples within 15 minutes of their collection,
place them temporarily in ice water. Measure these samples within 30 minutes of
their collection. If you have not measured these samples 60 minutes after their
collection, dispose them.
o Samples with a PO2 level above 200 mmHg (26 kPa) should be collected in a glass
container if you are not able to measure them within 15 minutes of their
collection.
Plastic sample container Samples collected in plastic sample containers can be kept up to 30 minutes at room
temperature.
Roche Diagnostics
Preanalytics
Dialysis solution
Failure to follow sample handling protocols for dialysis solutions may lead to
incorrect patient results
WARNING Failure to follow sample handling protocols for dialysis solutions may lead to incorrect
patient results, which may endanger patient lives.
r When collecting dialysis solution to perform a measurement, collect fresh dialysate
with a syringe that does not contain any anticoagulants. Do not collect used dialysate.
Roche Diagnostics
Interferences
Interferences
A study was carried out to evaluate the influence of chemical substances and
pharmaceuticals that could interfere with measurement parameters.
The study was designed in accordance with the following CLSI guideline:
u Clinical and Laboratory Standards Institute. Interference testing in clinical chemistry,
CLSI document EP07-A2; Approved Guideline (2005), Vol. 25, No. 27
Incorrect results due to interference

r Find the list of potential interfering substances for BG/ISE/MSS and COOX parameters
WARNING in the tables below:
Substances without effect on BG, pH, ISE, Glu, Lac and Hct
Substance Concentration Tested analyte

3-beta-hydroxybutyric acid 20.0 mmol/L pH, ISE, Glu, Lac
Acetoacetic acid(1) 2.0 mmol/L pH, ISE, Glu, Lac
Acetone(1) 12.0 mmol/L BG, pH, ISE, Glu, Lac

Acetylcysteine 10.2 mmol/L Na+, K+, Cl-, Hct
Albumin > 9% BG, Na+, K+, Cl-, Glu, Lac, Hct
Ammonium chloride(1) 0.107 mmol/L BG, pH, ISE, Glu, Lac
Ampicillin(1) 0.15 mmol/L BG, pH, ISE, Glu, Lac
Ascorbic acid(1) 0.34 mmol/L ISE, Glu, Lac
Aspirin (acetylsalicylic acid)(1) 3.62 mmol/L Na+, K+, Cl-, Glu, Lac
Benzalkonium chloride 0.028 mmol/L pH, K+, Ca2+, Cl-, Glu, Lac
Bilirubin(1) 0.342 mmol/L BG, pH, ISE, Glu, Lac
Calcium chloride(1) 5.0 mmol/L ISE, Glu, Lac
Cefoxitin(1) 1.546 mmol/L ISE, Glu, Lac
Chlorpromazine(1) 0.0063 mmol/L BG, pH, ISE, Glu, Lac
Creatinine(1) 0.442 mmol/L BG, pH, ISE, Glu, Lac

Cyanide 0.1 mmol/L BG, pH, ISE, Glu, Lac
Cyclosporine 0.0043 mmol/L BG, pH, ISE, Glu, Lac
Dobesilate 0.88 mmol/L BG, ISE, Glu, Lac
Dobutamine 0.66 mmol/L pH, K+, Ca2+, Cl-, Glu, Lac
Dopamine(1) 0.00587 mmol/L BG, pH, ISE, Glu, Lac
Doxycycline(1) 0.068 mmol/L BG, pH, ISE, Glu, Lac
EDTA(1) 0.003 mmol/L ISE, Glu, Lac
Ethanol(1) 86.8 mmol/L BG, pH
Ethylen glycol(1) 4.83 mmol/L BG, pH, ISE, Glu, Lac

Gallamine triethiodide 0.056 mmol/L pH, ISE, Glu, Lac
Table 6-1 Substances without effect on BG, pH, ISE, Glu, Lac and Hct
Roche Diagnostics
Interferences
Gentamicin (1) 0.021 mmol/L BG, ISE, Glu, Lac
Gentisic acid(1) 0.117 mmol/L BG, pH, ISE, Glu, Lac
Glutathione, reduced(1) 3.0 mmol/L ISE, Glu, Lac

Glycolic acid 13.05 mmol/L PO2, Na+, K+, Cl-, Glu
Guaiacol 0.4 mmol/L BG, pH, ISE, Glu, Lac
HAES (hydroxyethylstarch) 50.0% BG, ISE, Glu, Lac, Hct
Halothane(1) 0.759 mmol/L PO2
Hemoglobin(1) 2.0 g/L BG, pH, ISE, Glu, Lac

Hydroxycarbamide (hydroxyurea) 2.50 mmol/L BG, pH, ISE
Ibuprofen(1) 2.425 mmol/L ISE, Glu, Lac
Isoflurane 3.0% BG, pH, ISE, Glu, Lac
Isoniazid(1) 0.292 mmol/L BG, pH, ISE, Glu, Lac
L-DOPA (Levodopa) 0.12 mmol/L BG, pH, ISE, Glu, Lac
Lactate(1) 6.6 mmol/L ISE, Glu
Lithium acetate(1) 3.20 mmol/L BG, pH, ISE, Glu, Lac

Magnesium acetate 15.0 mmol/L pH, ISE, Lac
Maltose 14.62 mmol/L BG, pH, ISE, Glu, Lac
Methyldopa(1) 0.071 mmol/L BG, pH, ISE, Glu, Lac
Metronidazole(1) 0.701 mmol/L pH, ISE, Glu, Lac
Monosodium phosphate(1) 9.0 mmol/L ISE, Glu, Lac

Nitrous oxide 85% PO2
Norepinephrine 0.12 mmol/L BG, pH, ISE, Lac
Paracetamol(1) 1.32 mmol/L BG, pH, ISE, Glu, Lac
PCO2 85.0 mmHg ISE, Glu, Lac
PCO2 0.0 mmHg PO2, ISE, Glu, Lac
Perphenazine(1) 0.223 μmol/L BG, pH, ISE, Glu, Lac
Phenobarbital(1) 0.431 mmol/L BG, pH, ISE, Glu, Lac

Phenylbutazone 1.3 mmol/L ISE, Glu, Lac
Phenytoin(1) 0.198 mmol/L BG, pH, ISE, Glu, Lac
PO2 600.0 mmHg BG, pH, ISE, Glu, Lac
PO2 < 25 mmHg BG, pH, ISE, Glu, Lac
Potassium chloride(1) 7.0 mmol/L BG, pH, ISE, Glu, Lac
Potassium oxalate(1) 0.081 mmol/L ISE, Glu, Lac

Potassium thiocyanate 6.88 mol/L BG, pH, Na+, Ca2+, Lac
Propofol 1.0% BG
Rifampicin(1) 0.078 mmol/L BG, pH, ISE, Glu, Lac
Salicylic acid 4.34 mmol/L K+, Ca2+, Glu, Lac
Sodium bromide 37.5 mmol/L pH, K+, Ca2+, Lac
Roche Diagnostics
Interferences
Sodium chloride(1) 45 mmol/L BG, pH, ISE, Glu, Lac
Sodium fluoride(1) 0.105 mmol/L BG, pH, ISE, Glu, Lac

Sodium glutamate 0.86 mmol/L ISE, Glu, Lac
Sodium heparin(1) 3000 IU/L BG, ISE, Glu, Lac
Sodium hydrogen carbonate 35 mmol/L ISE, Glu, Lac
(sodium bicarbonate)(1)
Sodium iodide 2.99 mmol/L BG, pH, K+, Ca2+, Glu, Lac
Sodium nitroprusside 4.00 mmol/L pH, K+, Ca2+, Glu, Lac
Sodium perchlorate 1.50 mmol/L K+, Glu, Lac
Sodium pyruvate(1) 0.309 mmol/L BG, pH, ISE, Glu, Lac
Theophylline(1) 0.222 mmol/L ISE, Glu, Lac
Thiopental (Trapanal)(1) 0.248 mmol/L pH, ISE, Glu, Lac

Triglyceride 37.0 mmol/L BG, pH, K+, Ca2+, Glu, Lac
Urea(1) 49.2 mmol/L BG, pH, ISE, Glu, Lac
Uric acid 1.40 mmol/L ISE, Glu, Lac
Vancomycin(1) 0.069 mmol/L BG, pH, ISE, Glu, Lac
Xylose 4.0 mmol/L BG, pH, ISE, Glu, Lac
(1) The substance and its concentrations are recommended in Clinical and Laboratory Standards Institute.
Interference testing in clinical chemistry, CLSI document EP07-A2; Approved Guideline (2005), Vol.
25, No. 27.
Substances without effect on tHb, SO2, Hb derivatives and bilirubin
Beta-carotin(1) 2.0 mg/L tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Evans blue 5 mg/L tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Gelofusine 1:1 dilution tHb. HHb. O2Hb, COHb, MetHb, SO2, Bili
HAES-sterile, 10% 1:1 dilution tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Hydroxocobalamin 0.25 mg/mL tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Indocyanine green 5 mg/L tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Intralipid, 20% 10 mg/mL tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Lipidem 10 mg/mL tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Lipofundin, 20% with MCT(1) 10 mg/mL tHb, HHb, O2Hb, COHb, MetHb, SO2
Methylene blue 2.5 mg/L tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Omegaven(1) 5 mg/mL tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili

Patent blue 2.5 mg/L tHb, HHb, O2Hb, COHb, MetHb, SO2
pH high 7.9 tHb, HHb, O2Hb, COHb, MetHb, SO2
pH high 8.0 Bili
Table 6-2 Substances without effect on tHb, SO2, Hb derivatives and bilirubin
Roche Diagnostics
Interferences

pH low 7.1 tHb, HHb, O2Hb, COHb, MetHb, SO2
pH low 6.7 Bili
Propofol, 2% 0.11 mg/mL tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
SMOF lipid, 20%(1) 10 mg/mL tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Total protein (Albumin)(1) 12 g/dL tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Voluven, 6%(1) 1:1 dilution tHb, HHb, O2Hb, COHb, MetHb, SO2, Bili
Table 6-2 Substances without effect on tHb, SO2, Hb derivatives and bilirubin
(1) The substance and its concentrations are recommended in Clinical and Laboratory Standards Institute.
Interference testing in clinical chemistry, CLSI document EP07-A2; Approved Guideline (2005), Vol.
25, No. 27.
Substances with effect on BG, pH, ISE, Glu, Lac and Hct
Parameter
Substance Effect of the substance ± Trueness
Substance Parameter concentration (MV)
concentration [mmol/L] [mmol/L]
[mmol/L]
Acetylcysteine 10.2 mmol/L(1) Glu 4.1 -1.4 ± 0.5 0.5
Lac 5.5 -1.4 ± 0.3 0.7
2.55 mmol/L Lac(2) 5.2 -0.6 ± 0.1 0.7
1.75 mmol/L Glu(2) 4.0 -0.1 ± 0.1 0.5
Benzalkonium chloride 0.0285 mmol/L Na+ 132.2 5.3 ± 0.9 2.9
0.0280 mmol/L Na+ 116.47 2.81 ± 0.42 2.940
152.20 4.07 ± 0.83 3.630
Na+
0.0143 mmol/L Na+(2) 138.4 2.1 ± 0.3 3.1
Dobutamine 0.066 mmol/L Na+ 137.4 21.2 ± 2.3 3.1
0.05 mmol/L Na+(2) 138.0 1.6 ± 0.2 3.1
Glycolic acid 13.05 mmol/L Lac 5.2 0.7 ± 0.5 0.7
(hydroxyacetic acid)
2.5 mmol/L Lac(2) 5.4 0.4 ± 0.2 0.7
Uric acid 1.4 mmol/L(1) Lac 6.0 -0.9 ± 0.1 0.7
0.35 mmol/L Lac(2) 5.4 -0.3 ± 0.1 0.7
Hydroxycarbamide 2.5 mmol/L Glu 4.0 1.2 ± 0.7 0.5
(hydroxyurea) Lac 4.8 -1.2 ± 0.6 0.7
0.63 mmol/L Glu (2) 3.8 0.1 ± 0.2 0.5
4.5 -0.4 ± 0.2 0.7
Lac(2)
Potassium thiocyanate 6.88 mmol/L(1) Cl- 107.7 176.5 ± 56.5 4.4
79.42 130.39 ± 43.09 4.0
Cl-
119.93 356.92 ± 120.59 4.8
Cl-
4.0 1.2 ± 0.4 0.5
Glu
3.44 mmol/L Glu(2) 3.9 0.4 ± 0.2 0.5
Table 6-3 Substances with effect on BG, pH, ISE, Glu, Lac and Hct
Roche Diagnostics
Interferences
Parameter
Substance Effect of the substance ± Trueness
Substance Parameter concentration (MV)
concentration [mmol/L] [mmol/L]
[mmol/L]
0.5 mmol/L Cl-(2) 104.8 3.5 ± 0.9 4.3
Sodium chloride 45 mmol/L(1) Hct (3) 43.3% -9.4± 0.2% 3%
20 mmol/L Hct (3) 45.6% -3.8 ± 0.3% 3%
10 mmol/L Hct(2)(3) 45.6% -0.9 ± 0.2% 3%
Sodium bromide 37.5 mmol/L(1) Cl- 80.09 147.99 ± 24.5 4.0
103.7 111.1 ± 12.0 4.2
Cl-
119.01 147.04 ± 17.87 4.77
Cl-
4.0 0.5 ± 0.3 0.5
Glu
18.75 mmol/L Glu(2) 4.0 0.2 ± 0.1 0.5
1.0 mmol/L(1) Cl-(2) 105.5 4.0 ± 0.4 4.3

Sodium iodide 2.99 mmol/L(1) Cl- 80.63 26.74 ± 7.25 4.0
102.3 35.8 ± 13.8 4.2
Cl-
122.55 55.71 ± 19.11 4.9
Cl-
0.45 mmol/L Cl-(2) 105.3 1.3 ± 0.7 4.3
Sodium nitroprusside 4 mmol/L Cl- 102.5 10.4 ± 6.7 4.2
1 mmol/L Cl-(2) 104.4 3.3 ± 1.6 4.3
Sodium perchlorate 1.5 mmol/L Cl- 104.9 11.4 ± 3.8 4.3
0.375 mmol/L Cl-(2) 103.5 2.3 ± 0.8 4.3
Norepinephrine 0.118 mol/L Glu 4.1 -0.5 ± 0.2 0.5
0.06 mmol/L Glu(2) 4.5 -0.3 ± 0.1 0.5
Salicylic acid 4.34 mmol/L(1) Cl- 79.02 15.55 ± 2.84 4.0
117.3 20.48 ± 4.77 4.71
Cl-
104.0 20.3 ± 6.0 4.3
Lac
1.09 mmol/L Cl-(2) 103.6 1.8 ± 0.5 4.3
Table 6-3 Substances with effect on BG, pH, ISE, Glu, Lac and Hct
(1) The substance and its concentrations are recommended in Clinical and Laboratory Standards Institute. Interference testing in clinical chemistry,
CLSI document EP07-A2; Approved Guideline (2005), Vol. 25, No. 27.
(2) Within trueness specifications
(3) When determining interference for hematocrit, sample matrix modification (morphology of the erythrocytes, hemolysis, and osmosis effect) has to
be considered when adding substances. Therefore, sample modification was determined with an absolute reference measurement using
centrifugation (hemofuge), and the values determined with the cobas b 123 POC system were corrected.
Substances with effect on tHb, SO2, bilirubin and Hb derivatives
Roche Diagnostics
Interferences
Substance Parameter
Substance Parameter Effect of the substance ± Trueness
concentration concentration (MV)
Methylene blue 40.00 mg/L tHb 13.7 g/dL -1.1 g/dL 0.5 g/dL
O2Hb 97% -3.3% 3%
MetHb 0.5% 4.50% 1%
Bili 4.1 mg/dL -2.94 mg/dL 1.2 mg/dL
13.4 mg/dL -3.80 mg/dL 1.2 mg/dL
20.00 mg/L tHb(1) 13.7 g/dL -0.5 g/dL 0.5 g/dL
97% -3% 3%
O2Hb(1)
0.5% 3.6% 1%
MetHb
4.1 mg/dL -1.10 mg/dL (1) 1.2 mg/dL
Bili
13.4 mg/dL -1.43 mg/dL 1.2 mg/dL
10.00 mg/L MetHb 0.5% 2.3% 1%
Bili(1) 4.1 mg/dL -0.55 mg/dL 1.2 mg/dL
13.4 mg/dL -0.73 mg/dL 1.2 mg/dL
5 mg /L MetHb 0.5% 1.5% 1%
13.4 mg/dL -0.28 mg/dL 1.2 mg/dL
2.5 mg/L MetHb (1) 0.5 1.0% 1%
Evans blue 10 mg/L MetHb 0.5% 1.3% 1%
Bili 5.2 mg/dL 1.12 mg/dL 1.2 mg/dL
13.3 mg/dL 1.17 mg/dL 1.2 mg/dL
5 mg/L MetHb (1) 0.5% 0.6% 1%
Patent blue 10 mg/L MetHb 0.5% 3.2% 1%
13.7 mg/dL 5.6 mg/dL 1.2 mg/dL
5 mg/L MetHb 0.5% 1.6% 1%
13.7 mg/dL 2.94 mg/dL 1.2 mg/dL
2.5 mg/L MetHb (1) 0.5% 0.8% 1%
4.9 mg/dL 1.25 mg/dL 1.2 mg/dL
Bili(1)
13.7 mg/dL 1.40 mg/dL 1.2 mg/dL
Hydroxocobalamin 0.9 mg/mL tHb 13.6 g/dL 0.6 g/dL 0.5 g/dL
HHb 0.5% 4.2% 1.5%
O2Hb 97.7% -4.1% 3.0%
SO2 99.5% -4.3% 2%
14.2 mg/dL -1.39 mg/dL 1.2 mg/dL
0.5 mg/mL tHb (1) 13.6 g/dL 0.4 g/dL 0.5 g/dL
HHb 0.5% 2.5% 1.5%
97.7% -2.4% 3.0%
O2Hb(1)
99.5% -2.5% 2%
SO2
4.8 mg/dL -0.96 mg/dL 1.2 mg/dL
Bili
14.2 mg/dL -0.72 mg/dL 1.2 mg/dL
Table 6-4 Substances with effect on tHb, SO2, bilirubin and Hb derivatives
Roche Diagnostics
Interferences
Substance Parameter
Substance Parameter Effect of the substance ± Trueness
concentration concentration (MV)
0.25 mg/mL HHb(1) 0.5% 1.3% 1.5%
99.5% -4.3% 2.0%
SO2(1)
4.8 mg/dL -0.54 mg/dL 1.2 mg/dL
Bili(1)
14.2 mg/dL -0.36 mg/dL 1.2 mg/dL
Cyanomethemoglobin 10% HHb 2.1% 3.8% 1.5%
O2Hb 95.8% -3.4% 3.0%
SO2 97.9% -3.8% 2%
13.9 mg/dL 0.39 mg/dL 1.2 mg/dL
Sulfhemoglobin 10% tHb(2) ---(2) --- ---
--- ---
COHb(2) ---(2)
--- ---
HHb(2) ---(2)
--- ---
MetHb(2) ---(2) --- ---
O2Hb(2) ---(2) --- ---
SO2(2) ---(2) --- ---
5.2 mg/dL(2) --- ---
Bili(2)
-5.29 mg/dL 1.2 mg/dL
15.4 mg/dL(2)
5% Bili 15.4 mg/dL -2.10 mg/dL 1.2 mg/dL
2.5% Bili 15.4 mg/dL -1.04 mg/dL 1.2 mg/dL
Fluorescein 0.4 mg/mL tHb (2)
---(2) --- ---
--- ---
COHb(2) ---(2)
--- ---
HHb(2) ---(2)
--- ---
MetHb(2) ---(2) --- ---
O2Hb(2) ---(2) --- ---
SO2(2) ---(2) --- ---
Bili(2) ---(2)
0.25 mg/mL tHb(2) ---(2) --- ---

--- ---
COHb(2) ---(2)
--- ---
HHb(2) ---(2)
--- ---
MetHb(2) ---(2) --- ---
O2Hb(2) ---(2) --- ---
SO2(2) ---(2) --- ---
Bili(2) ---(2)
Table 6-4 Substances with effect on tHb, SO2, bilirubin and Hb derivatives
(1) Within trueness specifications
(2) No result displayed. “Spectral interference detected” message appears on the Results tab and the measurement printout.
Roche Diagnostics
Limitations of clinical analysis
Measured performance data can be influenced by known and unknown factors.

u Interferences (p. 145)
General information
Relevant literature lists various substances that can negatively impact measurement
results from blood samples. A detailed discussion of these phenomena can be found
at different places in the technical literature. Concerning the
cobas b 123 POC system, an attempt has been made to identify and evaluate these
possible influences. Since it is not possible to check all medication or substances, you
should be immediately informed with abnormal deviations of the measurement
results—as with every clinical analysis—and evaluate the complete picture of the
patient or perform more measurements in your own laboratory area, if necessary.
Plausibility check for neonatal bilirubin measurements
Incorrect bilirubin results due to inappropriate sample collection and handling

practices
WARNING Failing to follow appropriate sample collection and handling practices may lead to the
presence of cellular particles in blood samples. These cellular particles may lead to errors
and discrepancies in bilirubin measurement values.
r Do not squeeze the puncture site before collecting your blood sample.
r Immediately after collecting your blood sample, thoroughly mix it. This can be done by
rolling the sample between both hands and lightly inverting the sample collection
container, or using a mechanical instrument that rotates the sample on 2 axes. Then,
remove all air bubbles in the sample collection container.
r Analyze your blood samples as soon after sample collection as possible. If you have to
store blood samples before measuring, store them in the appropriate sample container
at the correct temperature.
u Sample handling (p. 143)
Cellular particles in blood samples may lead to the overestimation of neonatal

bilirubin results. Therefore, bilirubin measurements are run through a plausibility
check to identify erroneous results. This plausibility check is automatically
performed if the bilirubin result is greater than 15 mg/dL (256.5 μmol/L). To validate
the bilirubin results, the plausibility check compares tHb and/or MCHC results from
the same blood sample to their respective medical decision values.
q Critical values are set to default values based on reference ranges found in clinical
chemistry and molecular diagnostics textbooks. However, you have to configure critical
values to meet your own requirements. Use the table below to determine your neonatal
MCHC reference ranges.
Roche Diagnostics
Age MCHC (g/dL) MCHC (mmol/L)
1st day 31.0–35.0 4.805–5.425
2nd to 6th day 24.0–36.0 3.720–5.580
7th to 13th day n/a n/a
14th to 23rd day 26.0–34.0 4.030–5.270
24th to 37th day 25.0–34.0 3.875–5.270
Table 6-5 MCHC reference ranges for neonates
p To measure neonatal bilirubin

1 In the Configuration tab, press the following buttons: Measurement
> Result view > Display.
Make sure that bilirubin is in the Selected values column.
u Configuring the measurement results screen (p. 156)
2 In the Overview tab, measure your sample.
If the bilirubin result is less than 15 mg/dL (256.5 μmol/L), the bilirubin result is
displayed.
If the bilirubin result is greater than 15 mg/dL (256.5 μmol/L), the plausibility
check is performed.
o If the tHb, and, if Hct is measured, the MCHC results are less than each of
their respective medical decision values (22 g/dL, or 13.64 mmol/L, for tHb
and 36 g/dL, or 5.58 mmol/L, for MCHC), the bilirubin result is displayed.
o If the tHb and/or MCHC results, if Hct is measured, are greater than their
respective medical decision values (22 g/dL, or 13.64 mmol/L, for tHb and 36
g/dL, or 5.58 mmol/L, for MCHC), the bilirubin result is not displayed. If no
result for tHb is available, the bilirubin result is also not displayed.
Figure 6-1 Measurement display screen after a bilirubin measurement fails the
plausibility check
Roche Diagnostics
Configuring measurement input values
You can assign input values that can be edited in the Input values tab during a
measurement. This feature allows you to change measurement-specific information,
such as patient ID.
If you choose to make an input value mandatory, it will have the following properties:
o An asterisk beside the input.
o A yellow background.
o An acoustic warning indicating there is no input value, when detaching the
sample container.
o An acoustic and visual warning if you switch to the result screen when there is no
input value.
o An acoustic and visual warning when there is a timeout and no input value.
p To configure measurement input values

1 Utilities > Configuration > Measurement > Data input > Input values
Figure 6-2 Configuring measurement input values screen
2 To change the order of the input values in the Input values tab, select the input
value in the Input values panel and press the Move up and Move down buttons.
3 To add or remove input values, press the Edit list button.
Figure 6-3 Adding and removing input values screen
Roche Diagnostics
4 To add an input value, choose it from the list on the left panel of the screen and
press the button.
5 To remove an input value, choose it from the list on the right panel of the screen
and press the button.
6 To assign an input value as a mandatory input, choose it from the list on the right
panel of the screen and press the Mandatory input button.
An asterisk appears next to the input value on the right panel of the screen.
Mandatory input values have to be entered for each measurement.
In the screen in which they appear, mandatory inputs will have a flashing yellow
background together with an audible warning.
7 To set a default value for an input value, choose it from the list on the right panel
of the screen and press the Set default value button.
This feature is not available for all input values. If it is available for your selected
input value, the screen displays a numeric keyboard or a dialog box.
8 Enter your new default value in the numeric keyboard box or select it in the dialog
box. To apply it, press the OK button.
s
Roche Diagnostics
Configuring the measurement results screen
Configuring the measurement results screen
You can assign which measured and calculated values are displayed on the Results
tab during a measurement. This feature allows you to quickly display and record
specific values for all measurements.
p To add or remove parameters on the measurement results screen

1 Utilities > Configuration > Measurement > Results view > Display
Figure 6-4 Configuring measurement results display screen
2 To add a parameter, choose it from the Available values list and press
the button.
3 To remove a parameter, choose it from the Selected values list and press
the button.
4 To add all parameters from the Available values list, press the button.
5 To remove all parameters from the Selected values list, press the button.
s
Roche Diagnostics
Configuring the parameter selection field
The parameter selection field in the Overview tab makes it easier to view which
parameters are available before performing a measurement.
You can permanently disable parameters for measurements and calibrations, so these
parameters do not appear in the parameter selection field. In addition, you can
temporarily disable parameters for a measurement.
p To permanently enable and disable parameters for measurements and

calibrations
1 Utilities > Configuration > Measurement > Parameter > Activ./deactiv.
Figure 6-5 Permanently activating and deactivating parameters screen
2 To enable or disable a parameter for measurements, press on the parameter’s

button.
Parameters, which are shown in dark green, are permanently enabled for
measurements.
Parameters, which are shown in light green, are permanently disabled for
measurements.
3 To enable or disable a parameter for calibrations, press on the parameter’s
ON/OFF button.
Parameters, which have an ON button, are permanently enabled for calibrations.
Parameters, which have an OFF button, are permanently disabled for
calibrations.
s
p To temporarily enable and disable parameter for measurements
q If you disable a parameter on the Overview tab for a measurement, it is automatically

available for the next measurement.
1 In the Overview tab, select the parameters that you want to measure.
Parameters colored in dark green will be measured.
Parameters colored in light green will not be measured.
Roche Diagnostics
Figure 6-6 Overview tab
Creating user-defined parameter groups
Creating user-defined parameter groups makes it easier for you to activate the
measurement parameters you use most on the Overview tab. You can create up to 3
user-defined parameter groups with this feature.
p To create user-defined parameter groups

1 Utilities > Configuration > Measurement > Parameter > Edit panels
Figure 6-7 User-defined parameter group setup screen
2 To select a panel for the user-defined parameter group, press

the and buttons at the top of the Edit panels panel to choose one of the 3
panel buttons.
3 To change the name of the group, press the button. Enter your name using the
keyboard box that appears on the screen. To apply your name change, press the
OK button.
Roche Diagnostics
4 To add parameters to or remove parameters from the user-defined group, press

each parameter’s button.
Parameters, which are shown in dark green, are part of the group.
Parameters, which are shown in light green, are not part of the group.
s
Roche Diagnostics
Performing a measurement
Inappropriate collecting and handling of samples of human origin may result in

infection
WARNING Inappropriate collecting and/or handling samples of human origin may lead to the
transmission of blood or urine borne pathogens.

o Lab gloves
o Lab coat
o Eye protection
r If a sample of human origin is spilled, wipe it up immediately and apply a disinfectant.
r If a sample of human origin comes into contact with your skin, wash the affected area
immediately with soap and water an apply a disinfectant. Consult a physician.
Failure to follow QC protocols or ignoring QC results may lead to incorrect patient

results
WARNING Failure to follow QC protocols or ignoring QC results may lead to incorrect patient results,
r Follow quality control practices according to local regulations.
r Perform a minimum of one QC measurement each day. In addition, alternate through
the 3 levels of available QC materials over the course of 3 days. For example, perform a
QC measurement on day 1 with a level 1 QC material, on day 2 with a level 2 QC
material and on day 3 with a level 3 QC material.
r Perform QC tests on 3 levels after each of these actions: Fluid Pack and
Sensor Cartridge replacement, and installing and turning on the instrument.
r If QC results do not match their expected results, perform the QC measurements again.
If QC results still do not match their expected results, refer to the QC troubleshooting
section (QC troubleshooting (p. 218)). If the error persists, contact your Roche Service
representative.
r Do not use the system for diagnostic purposes until QC results match their expected
results.
NOTICE Using non-heparinized syringes or syringes with liquid heparin may lead to
inaccurate patient results
Non-heparinized syringes and syringes filled with liquid heparin, whose volume exceeds
the sample volume, does not prevent blood clotting in the syringe. Blood clots compromise
the integrity of the blood sample, which may lead to inaccurate patient results. In addition,
it may clog the instrument’s tubing paths.
r Use syringes containing balanced heparin salts. Roche recommends using the
Roche MICROSAMPLER PROTECT for blood collection.
Roche Diagnostics
q Proficiency test materials, also known as EQA materials, have to be measured in the
Proficiency test menu.
u Performing a proficiency test measurement (p. 194)
You can measure samples from syringes (without cannulae), capillaries and the
Roche MICROSAMPLER PROTECT.
p To perform a syringe measurement

1 Collect and prepare your sample for the measurement.
Make sure that there are no air bubbles in your sample. Gently roll the syringe in
between your hands for 10-15 seconds.
Figure 6-8 Proper rolling technique for sample mixing
Roche Diagnostics
3 To start the measurement, press the Start syringe measurement.
Improper docking of the syringe or injecting a sample into the fill port during a
syringe measurement may result in infection
WARNING Injecting your sample into the fill port or improper docking of the syringe while
performing a syringe measurement may lead to the sample leaking from the fill port.
This may result in the transmission of blood and urine borne pathogens. In addition, it
may lead to a loss of sample.
r Do not inject the sample into the fill port while performing a syringe measurement.
r Do not hold onto the syringe after attaching it to the fill port.
r If a sample of human origin is spilled, wipe it up immediately and apply a
disinfectant.
r If a sample of human origin comes into contact with your skin, wash the affected
area immediately with soap and water, and apply a disinfectant. Consult a
physician.
r Firmly attach the syringe to the fill port.
4 Firmly attach the syringe to the fill port. Then, remove your hand from the
syringe.
Figure 6-10 Attaching the syringe to the fill port
Roche Diagnostics
5 To aspirate your sample, press the Yes button.
Figure 6-11 Aspirating your sample from the syringe
6 When you receive the prompt on the screen to remove the syringe, remove the
syringe from the fill port and press Yes.
The instrument performs the syringe measurement.
Figure 6-12 Removing the syringe from the fill port
Roche Diagnostics
7 In the Input values tab, press the button to enter your input values.
To avoid incorrect results, enter the correct sample type for each syringe
measurement.
WARNING
Figure 6-13 Input values tab during a syringe measurement
8 To view your results, enter the Results tab.
Figure 6-14 Results tab after a syringe measurement
9 To return to the Overview tab, press the button.

s
Roche Diagnostics
p To perform a measurement with a capillary or a

NOTICE Using inappropriate capillary tubes may result in damage to the analyzer
Performing capillary measurements with inappropriate capillary tubes may damage the
analyzer.
r Roche recommends using its glass capillary tubes or
Roche MICROSAMPLER PROTECT for blood collection. If you use glass capillary tubes
from other manufacturers, ensure that they have heat-polished ends.
u Available accessories and consumables (p. 335)
1 Collect your sample for the measurement.

Measure your sample no later than 15 minutes after you have collected it.
3 To start the measurement, press the Start capillary measurement.
Roche Diagnostics
4 Firmly attach the capillary or the Roche MICROSAMPLER PROTECT to the fill
port. Then, remove your hand from the sample collection container.
Figure 6-16 Attaching the capillary to the fill port
Figure 6-17 Attaching the Roche MICROSAMPLER PROTECT to the fill port
Roche Diagnostics
5 To aspirate your sample, press the Yes button.
Figure 6-18 Aspirating your sample from the capillary or the

6 When you receive the prompt on the screen to remove the capillary, remove the
capillary or the Roche MICROSAMPLER PROTECT from the fill port and press
Yes.
The instrument performs the capillary measurement.
Figure 6-19 Removing the capillary or the Roche MICROSAMPLER PROTECT from the fill
port
Roche Diagnostics
7 In the Input values tab, press the button to enter your input values.
To avoid incorrect results, enter the correct sample type for each capillary
measurement.
WARNING
Figure 6-20 Input values tab during a capillary measurement
8 To view your results, enter the Results tab.
Figure 6-21 Results tab after a capillary measurement
9 To return to the Overview tab, press the button.

s
Roche Diagnostics
Measurement modes
Measurement modes
Micro mode When you perform a capillary measurement, the instrument automatically switches
to micro mode if it aspirates a blood sample with a volume less than 123 μL.
The Input values tab indicates if the instrument has performed a measurement in
micro mode.
u Input values tab in micro mode (p. 169)
A Sample mode: Normal/Micro
Figure 6-22 Input values tab in micro mode
Minimum sample volumes Minimum sample volumes to measure specific parameter groups (BG, ISE, COOX
and Glu/Lac) depend on the number of activated parameters and the sample volume.
The following table shows the minimum sample volumes to measure these parameter
groups:
Sample volume BG ISE Glu/Lac COOX

 37 μL Insufficient Insufficient Insufficient
volume(1) volume(1) volume(1)
55 μL Insufficient Insufficient
volume(1) volume(1)
Table 6-6 Sample volumes
(1) This message appears on the Results tab and the measurement printout.
Roche Diagnostics
Entering measurement input values
You can enter various patient, operator, and sample-specific input values during a
measurement in the Input values tab. This can be done manually, or using a barcode
scanner.
NOTICE Measurement results acceptance

Measurement results are not accepted and do not appear in the measuring database.
r Always input a value for a mandatory input for a measurement.
r Always confirm a standard value or enter a new standard value for a measurement.
q If a patient’s information is already in the measuring database, its data will automatically be
entered during a measurement.
If you have activated an external query to the LIS, patient data will be transmitted from the
LIS to the instrument.
u Configuring measurement input values (p. 154)
Mandatory inputs Mandatory inputs have the following properties:

o An asterisk beside the input.
o A yellow background.
o An acoustic warning indicating there is no input value, when detaching the
sample container.
o An acoustic and visual warning if you switch to the result screen when there is no
input value.
o An acoustic and visual warning when there is a timeout and no input value.
Figure 6-23 Mandatory inputs in the Input values tab
If a standard value is defined as a mandatory input, this value has to be confirmed or

a new value has to be entered for each measurement.
u Standard values and ranges (p. 97)
Roche Diagnostics
Measurement results are not accepted and do not appear in the measuring database
o if you do not input a value for mandatory input for a measurement
o if you do not confirm a standard value or enter a new standard value for a
measurement
p To manually enter measurement input values

1 In the Input values tab, select the input value that you want to enter data for.
Figure 6-24 Input values tab
2 To enter data for the input value, press the button.

A numerical keyboard, keyboard or dialog box appears on the screen.
3 Enter the data for the input value on the instrument.
4 To confirm your entry, press the OK button.
s
Roche Diagnostics
p To enter measurement input values using a barcode scanner

Incorrect results due to errors in scanning barcodes
Errors in scanning barcodes may lead to patient-specific information being incorrectly
WARNING entered into the system. This leads to incorrect results, which may lead to incorrect patient
diagnoses and endanger patient lives.
r Immediately after scanning a barcode, check that the displayed patient information on
the system matches the registered patient information.
1 In the Input values tab, select the input value that you want to enter using the
barcode scanner.
Figure 6-25 Input values tab
2 Using the barcode scanner, scan the barcode that contains the input value data.
3 Verify that the barcode was scanned correctly by checking the displayed
information on the instrument.
s
Roche Diagnostics
Measurement results and reports
Results tab When one measured value is available, the Results tab automatically appears. You
can continue to enter input values by returning to the Input values tab.
You can assign which measured and calculated values are displayed on the Results
tab during a measurement.
u Configuring the measurement results screen (p. 156)
Figure 6-26 Results tab after a syringe measurement
This is the legend for the symbols shown in the Results tab. These symbols also
appear on measurement reports.
The value is below the physiological range.
The value is above the physiological range.
The value is below the critical range.
The value is above the critical range.
The value exceeds the upper limit of the measuring range.
The value is below the lower limit of the measuring range.
No measured value is available.
(c) Correlation factors have been applied to this measurement result.
Roche Diagnostics
(q) This measurement result was determined by a parameter with a QC warning.
u Status messages on the measurement report (p. 323)
You can increase the time-to-display setting to get a more accurate control of
measured values.
u To configure timeout settings (p. 266)
To return to the Overview tab after a measurement, press the button.
Measurement reports If one measured value is available and all mandatory inputs are entered, you can print
the measurement report by pressing the . button.
If a measurement is still in progress and the result is not available, the “Measurement
in progress” status message appears on the measurement report.
You can continue to edit input values after the first printout of the measurement
report.
Roche Diagnostics
Measuring database
Measuring database
You can find all measurements performed by your instrument in the measuring
database.
To enter the measuring database, press the following buttons: Workplace
> Measuring database
Figure 6-27 Measuring database
To sort database entries by start time, patient ID or last name, press their respective
column headers.
Roche Diagnostics
Acid base maps
Acid base maps
Acid base maps allow you to identify acid-base physiology disorders, such as
metabolic and respiratory acidosis and alkalosis, from pH and PCO2 measurements.
Figure 6-28 Acid base map
If pH and PCO2 results are available and all mandatory inputs have been entered, you
can view the acid base map for a measurement in the Acid base map tab.
In addition, you can view the acid base map for all measurements in the measuring
database.
Interpreting acid base maps Acid base map caption Acid base map information
A Metabolic acidosis
B Mixed met. & resp. acidosis
C Acute respiratory acidosis
D Mixed ac. & chr. resp. acidosis
E Chronic respiratory acidosis
F Mixed met. alkalosis & resp. acidosis
G Metabolic alkalosis
H Mixed resp. & met. alkalosis
I Acute respiratory alkalosis
J Mixed ac. & chr. resp. alkalosis
K Chronic respiratory alkalosis
L Mixed met. acidosis & resp. alkalosis
N Normal area
Table 6-7 Acid base map information
Roche Diagnostics
Patient trend diagrams
You can monitor all measured parameters for up to 10 days for a patient using
patient trend diagrams. You can only view up to 2 parameters on the same diagram.
Figure 6-29 Patient trend diagram
If all measured values are available, all mandatory inputs have been entered and you
have 2 or more measurements available from the same patient within the last 10 days,
you can view patient trending diagrams in the Patient trending tab.
In addition, you can view patient trending diagrams in the measuring database.
To change which parameters are shown in the patient trending diagram, press
the and buttons.
To view the measured values for a specific measurement on the patient trending
diagram, press the and buttons.
To change the time range of the diagram or the number of measurements shown on
the diagram, press the Change selection button. This is only available when viewing
the patient trend diagram from the measuring database.
Roche Diagnostics
Roche Diagnostics
cobas b 123 POC system 7 Quality control
Table of contents
Quality control 7
In this chapter, a detailed description of quality control procedures is provided. This

includes how to perform QC measurements and proficiency tests, how to
troubleshoot QC warnings and locks, and how to assess QC results.

General QC concept.......................................................................................................... 181
Important information for evaluating QC results ........................................................ 183
Performing QC measurements........................................................................................ 184
QC results and reports...................................................................................................... 191
QC database ....................................................................................................................... 192
Levey-Jennings graphs...................................................................................................... 193
Performing a proficiency test measurement.................................................................. 194
Configuring the QC scheduler ........................................................................................ 199
Defining and configuring QC materials ........................................................................ 203
Configuring QC rules and consequences ...................................................................... 207
Configuring QC settings .................................................................................................. 209
Evaluating QC measurement results .............................................................................. 211
Multirules ........................................................................................................................... 212
Removing QC consequences ........................................................................................... 215
QC troubleshooting .......................................................................................................... 218
Troubleshooting AutoQC module blockages ................................................................ 219
Roche Diagnostics
7 Quality control cobas b 123 POC system
Table of contents
Roche Diagnostics
General QC concept
General QC concept

results
representative.
results.
q Remember that a new AutoQC Pack must be adjusted to room temperature for at least
24 hours before use.
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.
To ensure the quality of measurement results, complete a quality control test on 3

levels (1 = low, 2 = normal, 3 = high) after each Sensor Cartridge replacement,
Fluid Pack replacement and after installation of the instrument.
In addition, complete a quality control test on one 1 level between 2 automatic 2P
calibrations. The levels have to be alternated (1 = low, 2 = normal, 3 = high).
For example, (2P calibration interval: 12 hours):
24 hours
2P-Cal. Level 1 2P-Cal. Level 2 2P-Cal. Level 3 2P-Cal. Level 1
Figure 7-1 Graphic illustration of the general QC concept
q A system calibration can be performed instead of a 2P calibration. Automatic system

calibrations include a complete 2P calibration.
Complete at least 2 quality control tests on different levels once daily or more often in
accordance with local regulations.
q QC measurements should not be run immediately before a 2P calibration.
Roche Diagnostics
General QC concept
A quality control program includes the analysis of sample materials with known
ranges of expected values and the comparison of these values with instrument results.
The following control materials are recommended:
o cobas b 123 AutoQC Pack TRI-LEVEL: This control material is only available for
instruments with an AutoQC module.
o COMBITROL PLUS B: This control material is to be used for manual QC
measurements.
Color codes for

COMBITROL PLUS B ampoules Red Level 1
Yellow Level 2
Blue Level 3
The target ranges specified in the package text should be taken as 2 ranges ( =
standard deviation; e.g. for PO2, 2 = 12 mmHg, 1 = 6 mmHg).
u Important information for evaluating QC results (p. 183)
Roche Diagnostics
Important information for evaluating QC results
Important information for evaluating QC results
QC measurement results are evaluated based on their  ranges:

o Measured value is within the target value range ± 2
O The QC result is acceptable and the parameter is/remains active for
measurements.
o Measured value is outside the target value range ± 2
O Consequence: A QC consequence is assigned to the parameter.
O The QC result is not acceptable. The parameter is locked for further
measurements. It is unlocked for further measurements when the cause of the
QC consequence has been determined and the error has been resolved.
O Repeat the QC measurement.
u Removing QC consequences (p. 215)
Roche Diagnostics
Performing QC measurements
You can perform the following types of QC measurements:

o AutoQC measurement
o User-activated AutoQC measurement
o Manual QC measurement
NOTICE Manual QC measurement
r When performing a manual QC measurement, enter or check the QC ranges from the
package insert.
AutoQC measurements AutoQC measurements are performed automatically at predefined times that you can
configure.
Figure 7-2 QC scheduler
q The results of an AutoQC measurement are not shown on the screen at the end of a
measurement. You can view the results of AutoQC measurements in the QC database.
u QC database (p. 192)
p To perform a user-activated AutoQC measurement
q User-activated QC measurements are only possible if the instrument is ready for a

measurement.
1 Workplace > QC measurement

The following window appears on the screen:
Figure 7-3 Quality control menu screen
Roche Diagnostics
2 In the AutoQC panel, press the button of one of the 3 QC levels that you want to
perform the QC measurement for.
The instrument performs the user-activated AutoQC measurement.
Figure 7-4 QC values tab during a user-activated AutoQC measurement
3 To enter the operator ID, press the button on the Operator ID field.
4 To accept or reject the results of the QC measurement, press the Accept or Reject
button.
Figure 7-5 QC values tab after a user-activated AutoQC measurement
p To perform a manual QC measurement
q Define your QC materials before performing a manual QC measurement.

u Defining and configuring QC materials (p. 203)
Roche Diagnostics
q COMBITROL PLUS B control material has to be acclimated to room temperature at least 24

hours before its use.
1 Workplace > QC measurement

Figure 7-6 Quality control menu screen
2 To enter the QC material information, scan the barcode on the ampoule’s label.
Alternatively, you can manually enter this information by pressing
the button on the Manual QC panel and using the keyboard box that
appears on the screen. Then, press the OK button.
Use the QC material Insert Sheet to check the QC ranges entered.
3 Make sure that the QC material information that appears on the screen is correct.
Figure 7-7 QC measurement overview screen
4 To start the QC measurement, press the Start capillary measurement button.
Roche Diagnostics
5 Gently tap the head of the ampoule with your fingernail to remove any liquid
from the top.
Figure 7-8 Tapping the head of the ampoule
6 Break open the ampoule using gauze.
Figure 7-9 Opening the ampoule
Personal injury due to contact with glass splinters from broken QC ampoules
Glass splinters created when breaking QC ampoules may result in personal injury.
CAUTION r When you break QC ampoules, use several layers of gauze and wear appropriate
personal protective equipment, such as:
o Lab gloves
o Lab coat
o Eye protection
Roche Diagnostics
Failure to follow QC protocols may lead to incorrect patient results

Failure to follow QC protocols may lead to incorrect patient results, which may
WARNING endanger patient lives.
r Perform QC measurements within 30 seconds of opening the QC ampoule.
Immediately discard the ampoule after performing the manual QC measurement.
r Use an ampoule adapter to carry out the manual QC measurement.
7 Firmly attach the ampoule adapter to the fill port.
Figure 7-10 Attaching the ampoule adapater to the fill port
8 To aspirate the contents of the ampoule, press the Yes button.
Figure 7-11 Aspirating the contents from the ampoule
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ampoule adapter from the fill port and press Yes.
Figure 7-12 Removing the ampoule adapter from the fill port
The instrument performs the manual QC measurement.
Figure 7-13 QC values tab during a manual QC measurement
Roche Diagnostics
11 To accept or reject the results of the QC measurement, press the Accept or Reject
button.
Figure 7-14 QC values tab after a manual QC measurement
Roche Diagnostics
QC results and reports
QC results and reports
QC values tab
Figure 7-15 QC values tab after a manual QC measurement
This is the legend for the text shown in the QC values tab. This text also appears on
measurement reports.
OK The value is inside the target range.

nOK The value is outside the target range.
Roche Diagnostics
QC database
QC database
You can find all QC measurements performed by your instrument in the QC

database.
To enter the QC database, press the following buttons: Workplace > QC database
Figure 7-16 QC database
The first column in the database shows the overall status of all of the parameters after
the QC measurement. The following symbols are used:
No parameters were assigned a QC warning or lock after this QC measurement.
1 or more parameters were assigned a QC warning or lock after this QC

measurement.
To sort database entries by start time, QC type, level or lot, press their respective
column headers.
Roche Diagnostics
Levey-Jennings graphs
Levey-Jennings graphs
Levey-Jennings graphs show the progress of QC measurement results, in order to

help you find errors in how the system measures.
These graphs are created for each parameter using QC measurement results
performed on the same QC material and level.
Figure 7-17 Levey-Jennings graph
q Levey-Jennings graphs are not available for proficiency test measurements.
If you have performed at least 1 other QC measurement with the same QC material
and level, you can view these graphs in the Levey-Jennings graph tab.
In addition, you can view Levey-Jennings graphs in the QC database.
To change which parameters are shown in the Levey-Jennings graph, press
the and buttons on the Parameter field.
To view the measured values for a specific QC measurement on the Levey-Jennings
graph, press the and buttons.
To change the time range of the graph, press the buttons on the Date/time from
and Date/time to: fields. Enter your desired date and time using the schedule dialog
box that appears on the screen.
Roche Diagnostics
Performing a proficiency test measurement
NOTICE To verify the accuracy of measurement values, perform proficiency testing.
Roche recommends that you perform proficiency testing to verify the accuracy of
measurement values. Proficiency test materials may contain interfering components,
missing or insufficient buffer systems, and differences in ionic strength and diffusion
potential compared to biological samples, and may affect the accuracy of
measurement values.
NOTICE The cobas b 123 POC system can measure proficiency test or EQA materials.
However, results are not obtained if they are outside of the measuring range or
outside of the system specifications. This may occur because the concentration of
these materials is unknown, or the materials’ formulations are incompatible with
the instrument.
r Roche recommends that you carefully establish and monitor your participation in
external programs, and compare your results within your peer group using
cobas b 123 POC systems.
r Follow material instructions related to its transportation and storage conditions,
temperature equilibrium and mixing before use.
q In cases where security level 3 or 4 is activated, the proficiency test function is available
only for the following operator profiles: trusted operator, service operator, key operator,
and supervisor.
u Configuring operator settings (p. 278)
q Correlation factors are not applied to proficiency test results.
q Before you perform a proficiency test, regularly measure QC materials and make sure that
their results are within expected ranges.
Sensor interference
Some proficiency QC materials can interfere with the sensor.
WARNING r After completing the proficiency test, perform a system calibration and QC
measurement on 3 levels.
Roche Diagnostics
p To perform a proficiency test measurement

1 Workplace > QC measurement > Proficiency test
Figure 7-18 Proficiency material setup screen
2 To enter the material name, level and lot number of the proficiency test material,
scan the barcode on the ampoule’s label.
Alternatively, you can manually enter this information by pressing
the button and using the keyboard box that appears on the screen.
3 Press the Start measurement button.
4 Make sure that the proficiency test material information that appears on the
screen is correct.
Figure 7-19 Proficiency test overview screen
5 To start the proficiency test, press the Start capillary measurement button.
Roche Diagnostics
6 Follow the instructions of the proficiency material manufacturer for handling and
preparation.
Failure to follow proficiency test protocols may lead to incorrect proficiency

test results
WARNING Failure to follow proficiency test protocols may lead to incorrect proficiency test results.
r Follow proficiency test practices according to local regulations.
r Perform proficiency tests within 30 seconds of opening the proficiency test material
ampoule. Immediately discard the ampoule after performing the proficiency test.
r Use an ampoule adapter to carry out the proficiency test.
7 Firmly attach the ampoule adapter to the fill port.
Figure 7-20 Attaching the ampoule adapater to the fill port
8 To aspirate the contents of the ampoule, press the Yes button.
Figure 7-21 Aspirating the contents from the ampoule
Roche Diagnostics
ampoule adapter from the fill port and press Yes.
Figure 7-22 Removing the ampoule adapter from the fill port
The instrument performs the proficiency test.
Figure 7-23 Proficiency test values tab during a proficiency test
Roche Diagnostics
11 To accept or reject the results of the proficiency test, press the Accept or Reject
button.
Figure 7-24 Proficiency test values tab after a proficiency test
q Target ranges do not apply for proficiency tests.

Levey-Jennings graphs are not created for proficiency tests.
12 After completing the proficiency test, perform a system calibration and QC

measurement on 3 levels.
s
Roche Diagnostics
Configuring the QC scheduler
You can configure the QC scheduler to load manufacturer QC schemes, or create

your own QC times.
p To load the manufacturer QC scheme

1 Utilities > Configuration > Quality control > Times / intervals
2 Press the Load manufacturer QC scheme button.
A QC scheme is added into the QC scheduler.
The scheme contains the correct number of daily QC measurements needed for
the entire week. It also matches the QC scheduler with the scheduled 2P and
system calibration start times.
q The manufacturer QC scheme is not affected by additional 2P and system calibrations

performed during the RUN-IN phase or by drift-related changes to the calibration
scheme.
However, if you change the scheduled 2P calibration interval, you have to load the
manufacturer QC scheme again.
p To create a new time in the QC scheduler

Figure 7-25 QC scheduler screen
2 To select the day of the week for the new time, press the and buttons at the
top of the QC scheduler panel.
Roche Diagnostics
3 In the QC scheduler panel, press the New button.

Figure 7-26 AutoQC time configuration screen
4 To set a start time, press the button in the Start time field. Enter your start
time using the numeric keyboard box that appears on the screen. Then, press the
OK button.
5 To select a QC level for the new time, press the button in the
AutoQC time setting dialog box that corresponds to the QC level that you want
to assign.
6 To apply your changes, press the OK button.
s
p To copy times in QC scheduler for one day to another day

2 To select the day of the week that you want to copy times in QC scheduler for,
press the and buttons at the top of the QC scheduler panel.
Roche Diagnostics
3 To copy the times in QC scheduler for the selected day of the week, press the
Copy button.
Figure 7-28 Copying times in QC scheduler screen
4 To copy the times in QC scheduler to another day of the week, press the
corresponding button on the dialog box.
s
p To edit a time in the QC scheduler

2 To select the day of the week that you want to edit a time, press
the and buttons at the top of the QC scheduler panel.
Roche Diagnostics
3 To edit a time in the QC scheduler, select it from the drop-down list on the
QC scheduler panel. Then, press the Edit button.
Figure 7-30 AutoQC time configuration screen
4 To edit a start time, press the button in the Start time field. Enter your new
start time using the numeric keyboard box that appears on the screen. Then, press
the OK button.
5 To select a QC level for the new time, press the button in the
AutoQC time setting dialog box that corresponds to the QC level that you want
to assign.
s
p To delete a time in the QC scheduler

2 To select the day of the week that you want to delete a time, press
the and buttons at the top of the QC scheduler panel.
3 To delete a time in the QC scheduler, select it from the drop-down list on the
QC scheduler panel. Then, press the Delete button.
s
Roche Diagnostics
Defining and configuring QC materials
q AutoQC Packs do not need to be defined when they are installed.
Setting individual range limits Setting individual range limits are subject to the following limitations:
o Starting value is the currently valid value for the upper/lower limit:
O Factory values (2SD)
O RiliBÄK (Guidelines of the German Federal Medical Society) value (calculated
from the factory value)
O Previously configured multirules
o Make sure that the upper limit value for a QC material is higher than the lower
limit value.
o The permitted range for entering individual limits is limited to the range of the
factory limits. These limits cannot be extended because this would not ensure that
system specifications are fulfilled.
Range limit correction due to new Correction of range limits due to new Roche specifications for known QC materials is
manufacturer specifications performed using a modification barcode sheet provided by Roche after-sales service.
An accompanying letter lists the parameter(s) for which the new range limits are
provided.
u To edit the ranges for a QC material (p. 204)
q If individual range limits have been configured for one of the parameters affected by the
range limit correction, these are overwritten and the new factory values (2SD) and the
German RiliBÄK limits derived from them are taken over.
The identifier (E) is deleted in the “Type” column.
The limits of parameters that are not affected by the range limit correction are unchanged.
Any existing individual limits are maintained and identified using an (E).
p To define a new QC material

1 Utilities > Configuration > Quality control > Material definition > Setup
Roche Diagnostics
2 In the Setup QC material panel, press the New button.

Figure 7-33 QC setup wizard window
3 To enter the QC material’s information, scan the material and range codes from
its package insert using a barcode scanner.
4 Verify that the barcodes were scanned correctly by checking the displayed
information on the instrument. Then, press the OK button.
s
p To edit the ranges for a QC material

Roche Diagnostics
2 To edit the ranges for a QC material, select it from the drop-down list on the
Setup QC material panel. Then, press the Ranges button.
Figure 7-35 Editing QC material ranges screen
3 To edit the ranges for a specific parameter, select it from the drop-down list on
the window. If you want to edit the lower or upper limit of the ranges, press the
corresponding button. Enter your new range in the numeric keyboard box that
The parameter appears with an “(E)” in the Type column.
Figure 7-36 Editing QC material ranges screen
4 To reset the ranges for a specific parameter, select it from the drop-down list on
the window. Then, press the Reset line button.
5 To reset the ranges for all of the parameters, press the Reset all button.
s
Roche Diagnostics
p To delete a defined QC material

2 To delete the QC material, select it from the drop-down list on the

Setup QC material panel. Then, press the Delete button.
s
Roche Diagnostics
Configuring QC rules and consequences

results
representative.
results.
To ensure that there is a QC consequence when the rules for QC evaluation are
broken, you should assign all parameters to the QC consequence “QC lock”.
p To define QC rules and consequences for a parameter

1 Utilities > Configuration > Quality control > Rules / conseq
Figure 7-38 Rules and consequences
2 To select a parameter to define QC rules and consequences for, press

the and buttons at the top of the QC rules and consequences panel.
Roche Diagnostics
3 To define a QC rule for this parameter, press the and buttons in the Rules
panel.
The following QC rules are available:
None No rule
RiliBÄK RiliBÄK ranges(1)
Set 1 Rule 1 & Rule 2
Set 2 Rule 1, Rule 2 & Rule 4
Set 3 Rule 1, Rule 2, Rule 4 & Rule 5
Set 4 Rule 1, Rule 2, Rule 4, Rule 5 & Rule 6
2SD Default
(1) Default RiliBÄK ranges for software versions 4.5 and lower are from the 2008
RiliBÄK release. Default RiliBÄK ranges for software versions 4.7 and higher are
from the 2014 RiliBÄK release.
4 To define a QC consequence for this parameter, press the corresponding button

in the Consequences panel.
To apply no QC consequences for this parameter, press the None button.
s
p To enable QC repeats for a parameter
q Enabling the QC repeats feature allows the instrument to automatically repeat a QC

measurement at the same QC level if the rules for QC evaluation for selected parameters
are broken.
1 Utilities > Configuration > Quality control > Rules / conseq
Figure 7-39 Rules and consequences
2 To select a parameter to define QC rules and consequences for, press

the and buttons at the top of the QC rules and consequences panel.
3 To enable QC repeats for this parameter, make sure that the QC repeats button is
checked and highlighted. If the QC repeats button is not checked and
highlighted, press it.
s
Roche Diagnostics
Configuring QC settings
You can configure QC settings, such as automatic AutoQC measurements and

automatic QC measurement printouts, in the Utilities > Configuration
> Quality control menu.
p To configure automatic AutoQC measurements after specific instrument

actions
1 Utilities > Configuration > Quality control > AutoQC as follow-up
Figure 7-40 Configuring AutoQC measurement as follow-up screen
2 To configure automatic AutoQC measurements after Sensor Cartridge and

Fluid Pack changes and restarts, press the and buttons on each respective
field.
You can set the instrument to perform AutoQC measurements for specific QC
levels, all levels or to disable this feature.
s
Roche Diagnostics
p To activate/deactivate automatic QC measurement printouts
q Activating the automatic QC measurement printouts feature does not enable the printing
of AutoQC measurement results.
1 Utilities > Configuration > Quality control > Result view > Auto report
Figure 7-41 Configuring automatic QC measurement printouts
2 To activate automatic QC measurement printouts, press the and buttons

to display On on the Activate automatic report panel. Then, press the Close
button.
q The internal printer also has to be activated for the automatic QC measurement
printout feature to work.
u To activate/deactivate the internal printer (p. 267)
3 To select the number of copies of the QC measurement printout to print for each
QC measurement, press the and buttons on the Number of copies panel.
Then, press the Close button.
s
Roche Diagnostics
Evaluating QC measurement results
Evaluating QC measurement results
q If a parameter is not calibrated, no QC evaluation can take place. If this occurs, calibrate
the parameter and repeat the QC measurement.
The following methods for evaluating QC measurement results are available:
Verifying the ± 2σ range If the current QC result is within the ± 2 range corresponding to the specified target
value range (refer to package text or stored data on the memory chip), the respective
parameter is evaluated as “OK”.
If the current QC result is outside the ± 2 range, the respective parameter is
evaluated as “nOK”.
u Configuring QC rules and consequences (p. 207).
Multirules The evaluation of QC results is based on the Westgard(1) rules and their
interpretation for blood gas analysis(2). The Multirules process was derived from
these rules. It permits early detection of random and systematic errors associated
with the measuring device and its operation.
The aim of using a Multirule evaluation of your QC results is to keep false rejections
low while the error detection rate is kept high.
Within the Multirule evaluation, Rule 1 (2 SD limits) is not the only criteria for
evaluating but it is the precondition for any further evaluation by the other rules. QC
results within the 2 SD limits are in any case ok but a violation of the 2 SD limit is the
precondition to take the other rules into consideration. So, a QC measurement
always has to violate a combination of rules to be evaluated as nOK.
q The Multirules process can only be applied with a suitable control material.
(1) James O. Westgard. et al: A Multi-Rule Shewhart Chart for Quality Control in Clinical Chemistry.
Clinical Chemistry, Vol. 27, No.3, 1981
(2) 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
Roche Diagnostics
Multirules
Multirules
Overview 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
 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 of 3)2σ(1) 2 of 3 QC measurement values are outside x ± 2σ
NL = 3
4. 22σ 2 QC measurement values (m) are outside x ± 2σ
NL  2
5. 61σ 6 QC measurement values (m) are outside x ± 1σ
NT  6
6. 9m 9 QC measurement values (m) are on the same side as the mean value
NT  9
2SD range Defined target values (ranges)
Table 7-1 Multirules
(1) This rule is not used for QC evaluation on the system
q The Multirules process is applied after each individual QC measurement. The Multirules
are always applied only to the respective level.
The QC concept of the system uses combinations of multiple Multirules rules for
evaluation.
Rule combinations
q The activation of range 2SD automatically deactivates all other rules (rules 1–6).
The following Multirules rule combinations are possible on the system:
Set 1 Rule 1 and Rule 2.
OUT OF
OK
CONTROL 2
+3σ +3σ
+2σ +2σ
XM XM
–2σ –2σ
–3σ –3σ
A (Rule 1 = NOK) AND (Rule 2 = OK) = OK B (Rule 1 = NOK) AND (Rule 2 = NOK) = NOK
Figure 7-42 Multirules set 1
Roche Diagnostics
Multirules
Set 2 Rule 1, Rule 2 and Rule 4.
OUT OF
OK OK
CONTROL 4
+3σ +3σ +3σ

+2σ +2σ +2σ
XM XM XM
–2σ –2σ –2σ
–3σ –3σ –3σ
A (Rule 1 = NOK) AND ((Rule B (Rule 1 = NOK) AND ((Rule C (Rule 1 = NOK) AND ((Rule
2 = OK) OR (Rule 4 = OK)) 2 = OK) OR (Rule 4 = OK)) 2 = OK) OR (Rule 4 =
= OK = OK NOK)) = NOK
Set 3 Rule 1, Rule 2, Rule 4 and Rule 5.
OUT OF
OK OK
CONTROL 5
+3σ +3σ +3σ

+1σ +1σ +1σ
XM XM XM
–1σ –1σ –1σ
–3σ –3σ –3σ
A (Rule 1 = OK) AND ((Rule 2 B (Rule 1 = OK) AND ((Rule 2 C (Rule 1 = NOK) AND ((Rule
= OK) OR (Rule 4 = OK) = OK) OR (Rule 4 = OK) 2 = OK) OR (Rule 4 = OK)
OR (Rule 5 = OK)) = OK OR (Rule 5 = NOK)) = OK OR (Rule 5 = NOK)) = NOK
Roche Diagnostics
Multirules
Set 4 Rule 1, Rule 2, Rule 4, Rule 5 and Rule 6.
OUT OF
OK
CONTROL 6
+3σ +3σ
+1σ +1σ
XM XM
–1σ –1σ
–3σ –3σ
A (Rule 1 = OK) AND ((Rule 2 = OK) OR (Rule B (Rule 1 = NOK) AND ((Rule 2 = OK) OR
4 = OK) OR (Rule 5 = OK) OR (Rule 6 = (Rule 4 = OK) OR (Rule 5 = OK) OR (Rule 6
OK)) = OK = NOK)) = NOK
Roche Diagnostics
Removing QC consequences
You can view all QC locks or warnings on the instrument by pressing the Info button
on the Overview tab.
Figure 7-46 Parameter information screen
The “Parameter information” screen lists all parameters that have a QC lock or
warning. It also shows which QC material and level the QC lock or warning
corresponds to.
q Calibration and/or replacement of a Sensor Cartridge do not result in a QC lock.
Automatic correction To remove a QC consequence automatically, perform a user-activated AutoQC or

manual QC measurement with the correct QC level.
Roche Diagnostics
p To remove a QC consequence from a parameter manually
q If you have to manually remove a QC consequence, repeat the QC measurement with the
same level using a new QC ampoule for either manual or automatic QC from the same or a
different lot.
u Evaluating QC measurement results (p. 211)
1 In the Overview tab, press the Info button.

The following window appears on the screen.
2 To remove a parameter’s QC lock or warning, select the parameter and the

correct QC level from the drop-down list in the Parameter information screen.
Then, press the Remove parameter QC lock/warning button.
3 Perform a QC measurement with your new QC material.
s
p To remove QC consequences from all parameters manually

1 In the Overview tab, press the Info button.
The following window appears on the screen.
Roche Diagnostics
2 To remove QC locks or warnings from all parameters, press the

Remove all QC locks/warnings button.
3 Perform a QC measurement with your new QC material.
s
Roche Diagnostics
QC troubleshooting
QC troubleshooting
Description of the current problem After a QC measurement, one or more parameters are assessed as “nOK” (QC
warning or QC lock).
The affected parameters and the QC material (material type, level) causing the error
are listed under Workplace > QC database. If you want to remove a QC
consequence, repeat the QC measurement with the same level using a new QC
ampoule for either manual or automatic QC from the same or a different lot.
Classification of QC problems Group A: The cause is an aspirating or positioning problem with the QC sample. In
this case, more than one parameter is usually affected. You can identify a cause in
Group A in the QC database, where you see an error message instead of a result for
the affected parameters.
Group B: The cause is a QC result that exceeds the target range value. You can
identify a cause in Group B in the QC database, where you see that a result is available
but exceeds the target value range.
p To troubleshoot group A QC problems

1 Make sure that all of the parameters are calibrated.
2 Repeat the QC measurement with same QC material and level.
3 If the error still persists, contact your Roche Service representative.
s
p To troubleshoot group B QC problems

1 Perform a system calibration: Instrument > System calibration
2 If you performed a QC measurement after a Fluid Pack replacement, check that
the Fluid Pack was stored according to specifications before installation.
If you did not store it correctly, install a new Fluid Pack.
If you performed a manual QC measurement, check that the QC material was
acclimated to room temperature for at least 24 hours before its use.
If you acclimated the QC material correctly, check that the target value ranges in
the software match the target value ranges in the package insert.
If you performed an AutoQC measurement, check that the QC material was
acclimated to room temperature for at least 24 hours before its use.
Repeat the AutoQC measurement. If the issue persists, perform a manual QC
measurement with the same QC level.
3 Repeat the QC measurement with the same QC level.
If the issue persists and the oximeter parameters are affected, replace the
Fluid Pack. Then, repeat the QC measurement with the same QC level.
4 If the issue persists and the sensor parameters are affected, replace the
Sensor Cartridge. Then, repeat the QC measurement with the same QC level.
5 If the issue still persists, contact your Roche Service representative.
s
Roche Diagnostics
Troubleshooting AutoQC module blockages
Fragments of ampoules from the AutoQC Pack may escape and get stuck inside the
AutoQC module. This leads to blockages in the AutoQC module.
This issue is identified by the system with error ID 3001 (AutoQC module defective).
p To troubleshoot AutoQC module blockages

Removing ampoules fragments from the AutoQC module may result in injury
Ampoules are made of fragile glass that splinters easily, which may result in personal
CAUTION injury.
r Wear appropriate personal protective equipment, such as protective gloves and safety
glasses. Take extra care when working with protective gloves, which can easily be
pierced or cut, leading to personal injury
r To remove the fragments from the module, gently brush them out. Brush the fragments
away from you.
1 Press the AutoQC recovery button.

Loud sounds may be heard from the system because the movement of AutoQC
module components is blocked by ampoule fragments.
3 Using a fine brush, remove all loose ampoule fragments from inside the AutoQC
module.
Examples of typical AutoQC module blockages are shown below.
Figure 7-49 Ampoule head lost under the AutoQC module lift
Roche Diagnostics
Figure 7-50 Head and basket of an ampoule lost under the AutoQC module lift
Figure 7-51 Ampoule basket lost under the AutoQC module lift
4 Install a new AutoQC Pack.

5 If this error persists, contact your Roche Service representative.
s
Roche Diagnostics
cobas b 123 POC system 8 Calibration
Table of contents
Calibration 8
In this chapter, all automatic and user-activated calibrations are described.

General information ......................................................................................................... 223
Calibration schemes.................................................................................................... 223
Automatic calibrations...................................................................................................... 225
System calibration ....................................................................................................... 225
2P calibration............................................................................................................... 225
1P calibration............................................................................................................... 225
PO2 calibration ............................................................................................................ 225
Recalibration................................................................................................................ 226
Oximeter calibration................................................................................................... 226
Standby calibration ..................................................................................................... 226
Monitoring ................................................................................................................... 226
Standby shifting........................................................................................................... 226
Wash cycle.................................................................................................................... 227
User-activated calibrations............................................................................................... 228
Calibration for “Ready”.............................................................................................. 228
Calibration database ......................................................................................................... 229
Configuring calibration settings...................................................................................... 230
Roche Diagnostics
8 Calibration cobas b 123 POC system
Table of contents
Roche Diagnostics
General information
General information
Calibration compares the results of a known standard from your instrument with the
results for the same standard with other instruments. It ensures that there is
consistency between your measurements with the system, and determines that all of
your measurements are accurate and reliable.
Calibrations on the cobas b 123 POC system are performed with 3 stable aqueous
solutions found inside the Fluid Pack.
Calibrations are performed automatically at specific times. In addition, you can
perform manual calibrations at any time.
Calibration schemes
After inserting a new Sensor Cartridge, measurements from some parameters may
drift. Usually, this occurs in the RUN-IN phase. The system automatically monitors
drift in parameter values. If there is considerable sensor drift, the system
automatically switches to a different calibration scheme that performs 2P and PO2
calibrations more regularly.
Calibration scheme A Calibrations are performed at default intervals.

Calibration scheme B Calibrations are performed twice as often as in calibration
scheme A.
In addition, a standby calibration is run.
Calibration scheme C Calibrations are performed 4 times as often as in calibration
scheme A.
In addition, a standby calibration is run and the post-calibration
mode is enabled.
Calibration scheme D Calibrations are performed 4 times as often as in calibration
scheme A.
In addition, a standby calibration is run, the post-calibration
mode is enabled, and the PO2 parameter is assigned a calibration
alarm.
To view which calibration scheme your Sensor Cartridge is set to, press the following
buttons: Instrument > Consumable status. Then, select the Sensor Cartridge tab.
Roche Diagnostics
General information
A Calibration scheme
Figure 8-1 Consumable status window of the Sensor Cartridge
Roche Diagnostics
Automatic calibrations
q You cannot perform measurements, QC measurements or replacement routines during

most automated calibrations.
You can stop a 2P calibration or system calibration by pressing the button. 1P
calibrations cannot be stopped by pressing the button.
System calibration
q You can set a permanent start time for the system calibration, so it can occur when the
system is not in use, or the system’s workload is lower.
This calibration is performed every 24 hours (fixed interval, user-defined starting

time). It consists of:
o Wavelength calibration of the polychromator (optional)
o Calibration of the oximeter module lamp (optional)
o Cuvette layer thickness calibration (optional)
o 2-point calibration of all parameters
o O2 air calibration
o Determining the O2 value of the standby solution
u Configuring calibration settings (p. 230)
2P calibration
2P calibrations are performed every 4, 8 or 12 hours (default). The measurement

parameters are calibrated with 3 solutions (CAL 1, CAL 2 and standby solution) of
different concentrations. It consists of:
o Cuvette layer thickness calibration (optional)
o 2-point calibration of all parameters
u Configuring calibration settings (p. 230)
1P calibration
The time interval between 1P calibrations is 60 minutes. The measurement

parameters are calibrated using CAL 1 solution. It consists of:
o 1-point calibration of sensor parameters
PO2 calibration
The PO2 calibration measures the oxygen content in the standby solution.
The PO2 calibration is only available when your Sensor Cartridge is in the RUN-IN
phase. After the RUN-IN phase, the PO2 calibration is part of the system calibration.
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Recalibration
Recalibrations are carried out after each measurement. The measurement parameters
are calibrated using a standby solution.
Oximeter calibration
Oximeter calibration consists of a wavelength calibration of the polychromator, and a

calibration of the integration time and layer thickness calibration of the cuvette.(1)
Wavelength calibration of the It is performed during the system calibration. The known intensity maxima of the
polychromator built-in neon lamp, which is used as the spectral light source, is used as a reference to
calibrate the measured signal from the module.
A shortened wavelength calibration of the polychromator (1P calibration) occurs
with each measurement.
Calibration of the integration time It is also determined during system calibrations.
Cuvette layer thickness calibration
q After installing a new Fluid Pack, the cuvette has a 24-hour run-in time. During this time,
layer thickness calibrations are automatically performed at specified times.
It is performed during 2P and system calibrations. The measured absorption of a dye

in the CAL 2 solution is used to calibrate the cuvette layer thickness.
Standby calibration
If a change occurs in a parameter’s status, standby calibrations are performed every

30 minutes at the end of the last 1P calibration. The measurement parameters are
calibrated using the standby solution (2).
Monitoring
If there is a temporary change in the PO2 status between 2 calibrations, “Monitoring”

is entered in the calibration database, and the PO2 parameter is set to “Not
calibrated”.
Standby shifting
Standby shifting is the movement of standby solution in the measuring chamber.

This occurs 20 minutes after the last fluidic action (measurement or calibration) on
the instrument. In the calibration database, this is recorded as a STDBY shifting
entry.
(1) For instruments with COOX module only.

(2) Corresponds to BG 1P calibration for USA.
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Wash cycle
Wash cycle is the filling of the measuring chamber with new standby solution. This
occurs every hour on the instrument during the RUN-IN phase. In the calibration
database, this is recorded as a Wash cycle entry.
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User-activated calibrations
User-activated calibrations
User-activated calibrations are available in the Instrument tab.
Figure 8-2 Instrument tab
You can perform the following calibrations manually:

o Calibration for “Ready”
o 1-point calibration
o 2-point calibration
o System calibration
o Oximeter calibration(1)
u Automatic calibrations (p. 225)
q Manual calibrations can postpone scheduled automatic calibrations.
You can stop a 2P calibration or system calibration by pressing the button. 1P
calibrations cannot be stopped by pressing the button.
Calibration for “Ready”
The system automatically selects a calibration that sets all measurement parameters
to the “Ready” state.
(1) For instruments with COOX module only.
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Calibration database
Calibration database
You can find all calibrations performed by your instrument in the calibration
database.
To enter the calibration database, press the following buttons: Workplace
> Calibration database
Figure 8-3 Calibration database
The first column in the database shows the overall status of all of the measurement
parameters after the calibration. The following symbols are used:
All parameters were calibrated after this calibration.
1 or more parameters were not calibrated after this calibration.
To sort database entries by date and time or calibration type, press their respective
column headers.
Roche Diagnostics
Configuring calibration settings
You can configure when your instrument performs 2P and system calibrations in the
Calibration scheduler. In addition, you can activate or deactivate automatic printing
of calibration reports.
p To define the system calibration’s start time

1 Utilities > Configuration > Calibration > Times / intervals
2 To define the system calibration’s start time, press the button on the
System calibration panel.
Figure 8-4 Calibration scheduler screen
The screen displays a numeric scroll box.
Figure 8-5 Numeric scroll box for defining the system calibration’s start time
3 To set the correct start time, press the and buttons on the Start time panel.
Then, press the OK button.
s
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p To define the daily frequency of 2P calibrations
q To enable the automatic printing of calibration reports, the internal printer has to be
activated.
1 Utilities > Configuration > Calibration > Times / intervals

2 To define the daily frequency of 2P calibrations, select 1 of the 3 interval options
on the 2 point calibration panel.
Figure 8-6 Calibration scheduler screen
The starting time of each 2P calibration is based on the starting time of the system
calibration.
For example, if you select the 8 h interval for 2P calibrations, and your start time
for system calibrations is 6:00 AM, 2P calibrations are performed on your
instrument at 2:00 PM, 10:00 PM and 6:00 AM.
s
p To activate/deactivate automatic printing of calibration reports

1 Utilities > Configuration > Calibration > Report > Auto report
Figure 8-7 Activate automatic report panel screen
Roche Diagnostics
2 To activate this feature, press the and buttons to display On in the

Activate automatic report panel. Then, press the Close button.
3 To deactivate this feature, press the and buttons to display Off in the
Activate automatic report panel. Then, press the Close button.
s
Roche Diagnostics
cobas b 123 POC system 9 Calibration verification control
Table of contents
Calibration verification control 9
Calibration verification allows you to test the accuracy of your instrument using
controls of known concentrations. This chapter describes the calibration verification
workflow on this system.

Installing AutoCVC Packs................................................................................................ 236
Performing an AutoCVC measurement......................................................................... 238
Managing CVC results in the QC database ................................................................... 240
Configuring analytical measurement ranges................................................................. 241
Roche Diagnostics
9 Calibration verification control cobas b 123 POC system
Table of contents
Roche Diagnostics
General information
General information
Calibration verification is used to test your instrument’s accuracy. Materials of

known concentration are used to assure that the instrument is accurately measuring
values throughout its measuring ranges.
This CVC has to be performed to fulfill CLIA-88 regulations at 42CFR493.1255(b)(3)
at least once every 6 months, or more often if:
o Fluid Pack and/or Sensor Cartridge lot numbers are changed, unless the
laboratory can demonstrate that changing reagent lot numbers does not affect the
ranges used to report patient test results, and control values are not adversely
affected by reagent lot number changes,
o There is major preventive maintenance or a replacement of critical parts that may
influence the instrument’s performance,
o After depot repair, or
o Control materials reflect an unusual trend or shift, or are outside of the specified
ranges.
Roche Diagnostics
Installing AutoCVC Packs
Removing the AutoQC Pack from the instrument may result in injury
Glass splinters from broken ampoules inside the AutoQC Pack may escape when you
CAUTION remove the AutoQC Pack. This may result in personal injury.
glasses.
r When handling and disposing AutoQC Packs, wear appropriate personal protective
equipment, such as laboratory clothing, protective gloves, safety glasses, face masks,
and safety visors, to prevent personal injury.
r When handling and disposing AutoQC Packs, prevent personal injury by wearing
appropriate personal protective equipment, such as:
o Lab gloves
o Lab coat
o Eye protection
r Take extra care when working with protective gloves, which can easily be pierced or
cut, leading to personal injury.
Turning over an AutoCVC Pack may result in spilled liquid

Reinstalling an AutoCVC Pack that has been turned over may spill AutoCVC material. In
CAUTION addition, glass splinters from broken ampoules may destroy the AutoQC module.
r If you plan on reinstalling a used AutoCVC Pack, keep it in an upright position when it
is outside of the instrument.
r If liquid does spill from the AutoCVC Pack, wipe it up immediately and apply a
NOTICE Inserting damaged AutoCVC Packs may damage the instrument

If damaged AutoCVC Packs are inserted into the cobas b 123 POC system, the AutoQC
module may become damaged.
r Before inserting AutoCVC Packs into the instrument for the first time, check for
possible damage during transportation. If an AutoCVC Pack shows evidence of
damage, do not insert it into the instrument.
q AutoCVC Packs have to be acclimated to room temperature at least 24 hours before its
use.
Roche Diagnostics
p To install an AutoCVC Pack

1 Workplace > Change AutoQC Pack
When you have installed the AutoCVC material, AutoCVC text replaces
AutoQC Pack information on the Overview tab.
A AutoCVC
Figure 9-1 Overview tab with an installed AutoCVC Pack
Roche Diagnostics
Performing an AutoCVC measurement
p To perform an AutoCVC measurement

1 Workplace > Calibration verification
The following dialog box appears on the screen:
Figure 9-2 Configuring AutoCVC measurement screen
2 To start the measurement, press one of the level buttons (Level 1–Level 6).
The CVC column on the dialog box represents the number of performed CVC
measurements at this level with the installed AutoCVC module.
The Ampoules column on the dialog box represents the number of remaining
ampoules at this level in the installed AutoCVC module.
3 To view your results, enter the CVC values tab.
Figure 9-3 CVC values tab after an AutoCVC measurement
If a parameter’s CVC result is within the target range, OK text is displayed next to
the parameter’s CVC result in the CVC values tab.
If a parameter’s CVC result is not within the target range, the parameter’s CVC
results in the CVC values tab is shaded in red and nOK text is displayed next to it.
Roche Diagnostics
4 To accept or reject the AutoCVC measurement’s results, press the Accept or

Reject button in the CVC values tab.
Accepted AutoCVC measurement results are stored in the QC database.
Rejected AutoCVC measurement results are not stored in the QC database.
q If you do not press the Accept or Reject button after 30 seconds and there are no
mandatory inputs to enter, the AutoCVC measurement’s results are automatically
accepted.
If you do not press the Accept or Reject button after 30 seconds and there are
missing mandatory inputs, the AutoCVC measurement’s results are automatically
rejected.
Roche Diagnostics
Managing CVC results in the QC database
Managing CVC results in the QC database
You can find all CVC measurements performed by your instrument in the QC
database.
To enter the QC database, press the following buttons: Workplace > QC database.
Figure 9-4 CVC measurement results in the QC database
The first column in the database shows the overall status of all of the measurement
parameters for the CVC measurement. The following symbols are used:
All parameters for this measurement were within the target ranges.
1 or more parameters for this measurement were not within the target ranges.
To sort the database entries by start time, QC type, level or lot, press their respective
column headers.
Roche Diagnostics
Configuring analytical measurement ranges
AMRs are ranges of values that an instrument can report directly without needing to
dilute or increase the sample concentration. You may need to create or edit your
instrument’s AMR values based on CVC measurement results or local regulations.
p To add a new AMR

1 Utilities > Configuration > Measurement > Parameter > AMR
2 Press the New button.
Figure 9-5 Configuring AMR screen
3 To select a parameter, press the and buttons on the Parameter panel.
Figure 9-6 Adding an AMR screen
Roche Diagnostics
4 To enter the lower or upper limit, press the button. Then, enter your lower or
upper limit using the numeric keyboard box that appears on the screen. To apply
them, press the OK button.
q New ranges have to be within the measuring ranges.
5 To save your new AMRs, press the OK button.

s
p To edit an AMR
1 Utilities > Configuration > Measurement > Parameter > AMR
2 Press the Edit button.
Figure 9-7 Configuring AMR screen
3 To edit the lower or upper limit, press the button. Then, enter your lower or
upper limit using the numeric keyboard box that appears on the screen. To apply
them, press the OK button.
Figure 9-8 Editing an AMR screen
Roche Diagnostics
q New ranges have to be within the measuring ranges.
4 To save your changes, press the OK button.

s
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Roche Diagnostics
cobas b 123 POC system 10 Software functions
Table of contents
Software functions 10
This chapter describes the system’s software tabs, icons and databases. In addition,
instructions on how to configure system settings, such as network connections and
user access, are provided.

General software information ......................................................................................... 247
Overview tab...................................................................................................................... 251
Description of the screen areas........................................................................................ 252
Workplace tab .................................................................................................................... 255
Instrument tab ................................................................................................................... 256
Utilities tab ......................................................................................................................... 257
Instrument databases........................................................................................................ 258
Logging on and off ............................................................................................................ 260
Connecting USB storage devices..................................................................................... 261
Configuring system settings ............................................................................................ 262
Configuring network connection settings ..................................................................... 269
Configuring operator settings ......................................................................................... 278
Changing security levels................................................................................................... 282
Performing software and language updates................................................................... 284
Exporting and importing configuration settings .......................................................... 285
Audit trail ........................................................................................................................... 286
Available printout reports ................................................................................................ 288
Roche Diagnostics
10 Software functions cobas b 123 POC system
Table of contents
Roche Diagnostics
General software information
Software tabs The software on the system has 4 different tabs. You can configure specific settings or
get general information while measurements or calibrations are being performed, or
while other procedures are executing database actions.
All information (results, error messages, alarms, warnings, etc.) is

Overview
displayed, and measurements can be started.
You can perform individual replacement routines, manual QC
Workplace
measurements and individual databases.
All instrument data (e.g. status display) is displayed, and manual
Instrument
calibrations and various maintenance tasks can be started.
You can perform installation and put out of operation operations,
Utilities troubleshooting routines, and software updates. Also, you can
configure various settings.
Action buttons on the software The following buttons are available on the far right-hand side of the screen. The
buttons can be enabled or disabled depending on the operating status or software
function.
Log on/Log off

Press this button to log on or log off to or from the instrument.
You are required to log on to the system to perform specific functions.
Cancel
Press this button to interrupt an operation in progress, such as a calibration.
Print
Press this button to print results and other data that can be outputted from
the databases.
Legend
Press this button to get more information about the symbols shown on the
screen.
Help
Press this button to open the online help.
The online help contains references to other relevant topics. Use the table of
contents or index to find topics more easily.
Other software buttons

First entry
Move up
Move down
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Last entry
To the left
To the right
Edit sort
Menu closed – Menu open – Menu entry
Selection disabled – Selection enabled
Start a procedure (without input values)
Start a function (with input values)
Exit a function
Active function
Temporarily inactive function
Edit
Detail
Notation of measurement, input, Measured values (depending on the configuration):

and calculation values
PO2 Oxygen partial pressure
PCO2 Carbon dioxide partial pressure
pH Negative common logarithm of the hydrogen ion activity
Na+ Sodium ion concentration
K+ Potassium ion concentration
Cl– Chloride ion concentration
Ca2+ Calcium ion concentration

Hct Hematocrit
tHb Total hemoglobin concentration
O2Hb Oxyhemoglobin
HHb Deoxyhemoglobin
COHb Carboxyhemoglobin
MetHb Methemoglobin
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SO2 Functional oxygen saturation

Bili Bilirubin (neonatal)
Glu Glucose
Lac Lactate
Calculation values:
H+ Hydrogen ion concentration
cHCO3– Bicarbonate concentration in plasma
ctCO2(P) Total CO2 concentration in the plasma

ctCO2(B) Total CO2 concentration in the 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 O2 concentration
pHst Standard pH value
cHCO3–st Standard bicarbonate concentration in plasma
PAO2 Alveolar oxygen partial pressure

RI Respiratory index
nCa2+ Standardized ionized calcium (pH = 7.4)
Qs/Qt Shunt - quotient between both oxygen concentration differences
Qt Difference of oxygen concentration between alveolar and mixed venous
blood
P50 Oxygen partial pressure at 50% oxygen saturation calculated with SO2 as
measured value
FO2Hb Fractional oxygen saturation
SO2 Oxygen saturation
SO2(c) Functional oxygen saturation calculated with P50 as input value
AaDO2 Alveolar-arterial oxygen partial pressure
a/AO2 Alveolar-arterial oxygen partial pressure ratio
avDO2 Arterial-venous oxygen level difference
AG Anion gap
MCHC Mean corpuscular hemoglobin concentration
Osm Osmolality
OER Oxygen extraction ratio
Osmopt Optimized osmolality
Osmopt Gap Optimized osmolality gap
Hct(c) Hct calculated from tHb
PF index PaO2/FIO2 ratio
BO2 Oxygen capacity
Calculated values at the patient's temperature:
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PAO2t Alveolar oxygen partial pressure at patient's temperature
RIt Respiratory index at patient's temperature
AaDO2t Alveolar arterial pressure at patient's temperature
a/AO2t Alveolar-arterial oxygen partial pressure at patient's temperature
pHt pH at patient's temperature
PCO2t PCO2 at patient's temperature
PO2t PO2 at patient's temperature
cHt Hydrogen ion concentration at patient's temperature
Input parameters:
R Gas exchange quotient

FIO2 Inspiratory oxygen ratio
tHb(e) Entered tHb value (not measured)
Hb factor Serves to calculate Hct(c) values from tHb values
Osm(e) Entered osmolality value
Urea(e) Entered urea value
Additional items:
o Patient ID o Operator ID o Diagnosis

o Insurance code o Admission date/time o Medication
o First name o Admission status o Diagnostic code type
o Last name o Date/time drawn o Danger code
o Middle name o Sample type o Isolation status
o Suffix o Blood type o Vent. mode
o Maiden name o Puncture site o Oxygenation device
o Title o Specimen ID o VT
o Gender o Sample container o Srate
o Date of birth o Clinic o PEEP
o Age (A/F) o Hospital Service o CPAP
o Marital status o Ward o PIP
o Religion o Department o MAP
o Ethnic origin o Location o Ti
o Patient language o Doctor o Te
o Address o Accepted by o MV (Minute volume)
o Phone number o Billing code o Arate
o Size o Order ID o Flowrate
o Weight o Accession number o 24h urine
o Temperature o Discharge date/time o ALLEN Test
o Diet o Changed date/time o Remark 1 - 5
o Temporary Pat ID o Comment
Roche Diagnostics
Overview tab
Overview tab
All information (results, error messages, alarms, warnings, etc.) is displayed on this
tab. Measurements are also started in this menu.
I
C
D
J
F
M
G N
A Status area H Consumable status window

B Menu tab I Logon button
C Next calibration message window J Cancel button
D Next AutoQC measurement message window K Print button
E Parameter selection field L Info button
F Start measurement buttons M Legend button
G Alarm area and button N Online help button
Figure 10-1 User interface
Roche Diagnostics
Description of the screen areas
Status area The status of the instrument, and the date and time are displayed in this area. If a user
is logged on to the instrument, their user name is also displayed.
Figure 10-2 Status area
Additional information that may appear in this area:
[Username] Logged on user (first and last name in the second line)
Network connection is active
Network connection is not active
Service connection is active
ASTM/POCT1-A connection is active
ASTM/POCT1-A connection not active
If the status area is highlighted in yellow, there is an active service connection on the
instrument.
Figure 10-3 Active service connection
Next calibration message window The scheduled time for the next calibration is displayed.
Figure 10-4 Next calibration message window
u Calibration (p. 221)
Next AutoQC measurement The scheduled time for the next AutoQC measurement is displayed.
message window
Figure 10-5 Next AutoQC measurement message window
Roche Diagnostics
u Quality control (p. 179)
Parameter selection field You can select parameters or a parameter group for a specific measurement. Also, the
status of the individual parameters is indicated.
A Parameter group button B Parameter buttons
Figure 10-6 Parameter selection field
If a parameter is not ready, you can press its parameter button to view its status
report.
Parameter is activated and ready for measurement.
Parameter is temporarily deactivated, but ready for measurement.
Parameter is activated and ready for measurement, but there is a QC warning

assigned.
Parameter is temporarily deactivated, but ready for measurement. However,

there is a QC warning assigned.
Parameter is not ready for measurement because it is not calibrated, or has

been remotely locked.
Parameter is not ready for measurement because there is a QC lock on this

parameter.
Parameter is permanently deactivated.
The Info button shows the status report for all parameters that are not ready.
Parameter groups make it easier for you to activate the measurement parameters you
use most on the Overview tab. You can create up to 3 user-defined parameter groups
with this feature.
Parameter group button
Roche Diagnostics
Starting a measurement You can measure samples from syringes, without a needle or cannulae, capillaries
and the Roche MICROSAMPLER PROTECT.
Press the following buttons to start a measurement:
Start Roche MICROSAMPLER PROTECT or

capillary measurement
Start syringe measurement
u Performing a measurement (p. 160)
Consumable status window The status of the consumables is indicated in this area. The following symbols are
used:
Sensor Cartridge
AutoQC Pack
Fluid Pack
The remaining period of use or the remaining number of measurements is shown in

this window. In addition, a color bar indicates the consumable’s usage status. The
individual bars represent 10% increments in the consumable’s usage status.
Consumable level is OK
Warning level reached

The maximum period of use, or the maximum number of tests will soon be reached.
Only 20% of the consumable usage status is available and you and will need to soon
replace the consumable.
Alarm level reached
The maximum period of use, or the maximum number of tests has been reached. You
have to exchange the consumable immediately.
q If the Sensor Cartridge or Fluid Pack fill status reaches the alarm level, this results in a
system stop.
If the AutoQC Pack reaches the alarm level, this results in a warning.
u Consumable change (p. 297)
Roche Diagnostics
Workplace tab
Workplace tab
You can perform consumable changes, manual QC and CVC measurements, and
view databases in this tab.
E F
A I
B J
C G
D H
A Measuring database F Change Sensor Cartridge

B Calibration database G Change AutoQC Pack
C QC database H Change printer paper
D Instrument database I QC measurement
E Change Fluid Pack J Calibration verification
Figure 10-7 Workplace menu
Roche Diagnostics
Instrument tab
Instrument tab
All instrument data (i.e. status display) are displayed, and manual calibrations and
various maintenance tasks can be started from this tab.
F G
A I
B J
C H
A Calibration for "Ready F Instrument status

B 1 point calibration G Consumables status
C 2 point calibration H Parameter status
D System calibration I Disinfection of consumable area
E Oximeter calibration J Disinfection of touch screen
Figure 10-8 Instrument menu
Roche Diagnostics
Utilities tab
Utilities tab
You can perform installation and put out of operation procedures, troubleshooting
routines, and software updates in this tab. Also, you can configure various settings.
D E
A H
B I
C F
A Installation F Sensor Cartridge wetting routine

B Put out of operation G Sensor Cartridge internal wetting routine
C Switch off H Configuration
D Software update I Export/Import
E Language update
Figure 10-9 Utilities menu
Roche Diagnostics
Instrument databases
The instrument stores all measurement, calibration and quality control results, and
instrument activities from the last 90 days in its databases.
u Measuring database (p. 175)
u QC database (p. 192)
u Calibration database (p. 229)
To enter the measuring database, press the following buttons: Workplace

> Measuring database
To enter the quality control database, press the following buttons: Workplace
> QC database
To enter the calibration database, press the following buttons: Workplace
> Calibration database
To enter the instrument database, press the following buttons: Workplace
> Instrument database
To view more information about a specific result or instrument activity, press
the button.
p To search for an entry in the instrument’s database

1 Select the database that you want to search for an entry. Then, press
the button.
2 In the dialog box, enter your search criteria. Then, press the Search button.
A dialog box appears on the screen with all database entries that follow your
search criteria.
s
p To export data from a database to a storage device

1 From the following databases, select the one from which you want to export data:
o Measuring database
or,
o Calibration database
or,
o QC database
Note that data cannot be exported from the Instrument database by this method.
u Creating troubleshooting reports and log files (p. 329)
Roche Diagnostics
2 To add a database entry for export, use the drop-down list to choose it. Then,
press the button.
Figure 10-10 Export to USB storage device screen
p To print out a report from the instrument’s databases

1 Select the database that you want to export data from.
Figure 10-11 Calibration database
2 To select a database entry for printing, use the drop-down list to choose it. Then,
press the button.
s
Roche Diagnostics
Logging on and off
Logging on and off
p To log on to the system

1 In the Overview tab, press the button
Figure 10-12 Logon screen
2 To enter your operator ID and password, press the button.

The screen displays a keyboard box.
3 Enter your operator ID and password using the keyboard box. To confirm your
input, press the OK button.
4 To log on, press the OK button on the logon screen.
If your logon attempt is successful, your operator ID appears in the status area of
the Overview tab.
s
p To log off from the system

1 In the Overview tab, press the button.
s
Roche Diagnostics
Connecting USB storage devices
Connecting USB storage devices
p To connect a USB storage device

1 Press down on the gray cover on the left-hand side of the instrument.
u cobas b 123 POC system (p. 31)
The USB interface appears.
A B
A Gray cover B USB storage device
Figure 10-13 USB interfaces
2 To connect your USB storage device, insert it into the USB interface.
s
Roche Diagnostics
Configuring system settings
You can configure your system settings, such as instrument time, language and data
import and export preferences, in the Utilities > Configuration > System menu.
u To configure the instrument’s time (p. 263)
u To configure the instrument’s region and time zone (p. 263)
u To change the language (p. 264)
u To configure instrument’s volume settings (p. 265)
u To change the instrument name and hospital information (p. 265)
u To configure timeout settings (p. 266)
u To configure data imports and exports (p. 267)
When you press the Close button in the Utilities > Configuration > System menu, a
dialog box appears on the screen.
Figure 10-14 Confirming configuration changes screen
To save your changes, press the OK button.

To discard your changes, press the Discard button.
To return to the previous screen and change additional settings, press the Cancel
button.
Roche Diagnostics
p To configure the instrument’s time

1 Utilities > Configuration > System > Date / time
Figure 10-15 Configuring the date and time screen
2 To set the instrument’s time, press the button in the Set time field.
3 To enter your desired time, press the and buttons on the dialog box.
5 To set the time format, press the button in the Time format field.
6 In the dialog box, choose your desired time format from the drop-down list.
s
p To configure the instrument’s region and time zone

1 Utilities > Configuration > System > Date / time
Figure 10-16 Configuring the date and time screen
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2 To set your region and time zone, press the button in the Time zone field.
Figure 10-17 Selecting region and time zone dialog box
3 In the dialog box, choose your desired region and time zone from their
corresponding drop-down lists.
4 To apply your changes, press the OK button
s
p To change the language

1 Utilities > Configuration > System > Language
Figure 10-18 Language setup screen
2 In the Set language panel, choose your desired language from the drop-down list.
3 To apply your changes, press the Close button.
s
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p To configure instrument’s volume settings

1 Utilities > Configuration > System > Instrument > Volume
Figure 10-19 Configuring instrument volume screen
2 To set the general instrument volume, press the and buttons at the top of
the Set volume panel.
Setting the general volume to off turns off the instrument volume. Each increased
general volume level is louder than the previous level. max. is the loudest volume
level.
3 To activate the sound tone for touch clicks, information signals and alarm signals
1 and 2, make sure that the respective sound tone is checked and highlighted. If
the sound tone is not checked and highlighted, press it.
4 To test these tones, press the Test button.
s
p To change the instrument name and hospital information
q If you assign instrument names that exceed 30 characters, POCT1-A connections using
cobas bge link cannot be established.
1 Utilities > Configuration > System > Instrument > Information
Figure 10-20 Configuring instrument information screen
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2 To enter a new instrument name, press the button in the Instrument name
field.
3 To enter new hospital information, press the button in the
Hospital information field.
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p To configure timeout settings

1 Utilities > Configuration > System > Instrument > Timeouts
Figure 10-21 Configuring timeouts screen
2 To edit a timeout’s settings, use the drop-down list to choose which timeout that
you want to edit.
o To set a timeout to its default value, press the Default button.
or,
o To set a timeout to another value, press the Edit button.
Figure 10-22 Configuring timeouts dialog box
3 To edit this timeout, press the and buttons to enter your desired timeout
value.
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4 To apply your new timeout value, press the OK button.

s
p To activate/deactivate the internal printer

1 Utilities > Configuration > System > Instrument > Printer
Figure 10-23 Activate/deactivate internal printer panel screen
2 To activate the internal printer, press the and buttons to display Activated
in the Activate/deactivate internal printer panel. Then, press the Close button.
3 To deactivate the internal printer, press the and buttons to display
Deactivated in the Activate/deactivate internal printer panel. Then, press the
Close button.
s
p To configure data imports and exports

1 Utilities > Configuration > System > Export/import > CSV export
Figure 10-24 Configuring CSV exports screen
2 To select between the different delimiter formats, press the and buttons on
the Delimiter panel.
3 To select between the different decimal point formats, press
the and buttons on the Decimal point settings panel.
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s
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Configuring network connection settings
You can configure various network connection settings, such as how your system
sends patient results to information systems, or how your system connects to other
networks in the Utilities > Configuration > System > Connectivity menu.
u To automatically connect your system to a network using a DHCP server (p. 270)
u To manually connect your system to a network using an IP address (p. 271)
u To manually connect your system to a network using DHCP and DNS servers (p. 271)
u To configure ASTM protocol settings (p. 272)
u To configure POCT1-A protocol settings (p. 274)
u To activate/deactivate cobas® e-support (p. 275)
u To select a protocol for performing queries (p. 276)
u To enable remote operator management (p. 276)
u To add or remove parameters from an ASTM or a POCT1-A data transmission (p. 277)
When you press the Close button in the Utilities > Configuration > System
> Connectivity menu, a dialog box appears on the screen.
Figure 10-25 Confirming configuration changes screen
To save your changes, press the OK button.

To discard your changes, press the Discard button.
To return to the previous screen and change additional settings, press the Cancel
button.
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p To automatically connect your system to a network using a DHCP server

1 Utilities > Configuration > System > Connectivity > Network
Figure 10-26 Configuring network connection screen
2 In the IP address panel, press the and buttons on the upper part of the
panel to display DHCP.
The DNS panel becomes active.
3 In the DNS panel, press the and buttons on the upper part of the panel to
display Automatic.
s
Roche Diagnostics
p To manually connect your system to a network using an IP address

panel to display Manual.
3 To enter an IP, subnet mask and/or gateway address, press the button on their
respective fields. Enter your addresses using the numeric keyboard box that
s
p To manually connect your system to a network using DHCP and DNS

servers
Roche Diagnostics
panel to display DHCP.
The DNS panel becomes active.
3 In the DNS panel, press the and buttons on the upper part of the panel to
display Manual.
4 To enter a DNS IP address, press the button on the DNS 1 field. If you have to
enter a second DNS IP address, press the button on the DNS 2 field. Enter
your IP addresses using the numeric keyboard box that appears on the screen.
Then, press the OK button.
s
p To configure ASTM protocol settings

1 Utilities > Configuration > System > Connectivity > ASTM
Figure 10-31 ASTM configuration screen
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2 To activate the ASTM protocol on your instrument, press the and buttons
to display Activated in the upper panel of the screen.
The bottom panel of the screen becomes active.
Figure 10-32 ASTM configuration screen
q To send encrypted data using the ASTM protocol, activate the SSLv3/TLSv1 security
feature.
3 To activate SSLv3/TLSv1 security feature to the ASTM protocol, press

the and buttons on the Security field to display SSLv3/TLSv1.
4 To enter an IP address for the ASTM protocol, press the button on the
IP address field. Enter your IP address using the numeric keyboard box that
5 To enter a port number for the ASTM protocol, press the button on the Port
field. Enter your port number using the numeric keyboard box that appears on
the screen. Then, press the OK button.
6 To deactivate the ASTM protocol on your instrument, press
the and buttons to display Deactivated in the upper panel of the screen.
s
Roche Diagnostics
p To configure POCT1-A protocol settings

1 Utilities > Configuration > System > Connectivity > POCT1-A
Figure 10-33 POCT1-A configuration screen
2 To activate the POCT1-A protocol on your instrument, press

the and buttons to display Activated in the upper panel of the screen.
The bottom panel of the screen becomes active.
Figure 10-34 POCT1-A configuration screen
q To send encrypted data using the POCT1-A protocol, activate the SSLv3/TLSv1 security
feature.
3 To activate SSLv3/TLSv1 security feature to the POCT1-A protocol, press

the and buttons on the Security field to display SSLv3/TLSv1.
q The Keepalive feature automatically checks if there is an active connection between

your instrument and the corresponding information system (LIS or HIS).
4 To activate the Keepalive feature to the POCT1-A protocol, press

the and buttons on the Keepalive field to display Activated.
5 To enter an IP address for the POCT1-A protocol, press the button on the
IP address field. Enter your IP address using the numeric keyboard box that
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6 To enter a port number for the POCT1-A protocol, press the button on the
Port field. Enter your port number using the numeric keyboard box that appears
on the screen. Then, press the OK button.
7 To deactivate the POCT1-A protocol on your instrument, press
the and buttons to display Deactivated in the upper panel of the screen.
s
p To activate/deactivate cobas® e-support

1 Utilities > Configuration > System > Connectivity > cobas® e-support
Figure 10-35 Activate cobas® e-support screen
2 To activate cobas® e-support, press the and buttons to display Activated

on the Activate cobas® e-support panel. Then, press the Close button.
3 To deactivate cobas® e-support, press the and buttons to display
Deactivated on the Activate cobas® e-support panel. Then, press the Close
button.
s
Roche Diagnostics
p To select a protocol for performing queries
q ASTM or POCT1-A protocols have to be activated on the instrument to perform queries

with their respective protocols.
1 Utilities > Configuration > System > Connectivity > Queries
Figure 10-36 Configuring queries screen
2 To perform queries using the ASTM or POCT1-A protocols, make sure that their
respective buttons are highlighted in the Configure queries panel.
3 To disable queries, make sure that the Off button is highlighted.
s
p To enable remote operator management

Instrument unavailability when remote operator management is enabled
When remote operator management is enabled and being used, there is a possibility of the
WARNING instrument being locked and unavailable.
r Use caution when enabling remote operator management
1 Utilities > Configuration > System > Connectivity > Protocols
Figure 10-37 Remote operator management screen
Roche Diagnostics
2 To enable remote operator management, make sure that the

Remote operator management button is checked and highlighted. If the
Remote operator management button is not checked and highlighted, press it.
s
p To add or remove parameters from an ASTM or a POCT1-A data

transmission
1 Utilities > Configuration > System > Connectivity > Parameter
Figure 10-38 Configuring ASTM and POCT1-A data transmissions screen
2 To select between the ASTM and the POCT1-A protocols, press

the and buttons on the upper part of the Select values for parameters
panel.
3 To add a parameter, choose it from the Available values list and press
the button.
4 To remove a parameter, choose it from the Selected values list and press
the button.
5 To add all parameters from the Available values list, press the button.
6 To remove all parameters from the Selected values list, press the button.
7 To copy your settings for one of the protocols and add it to the other protocol,
press the Copy to button.
s
Roche Diagnostics
Configuring operator settings
To manage user access on the system, you can assign operator profiles for each user.
Operator profiles
Key Service Trusted Normal Trainee

Supervisor
operator operator operator operator operator
Measurement + + + + + +
Edit operator during measurement + + - + - -
QC measurement + + + + + +
Edit operator during QC
+ + - + - -
measurement
Proficiency test + + + + - -
Calibration + + + - - -
Calibration for “Ready” + + + + + +
Consumable changes + + + + + +
Remove QC lock + + + + - -
View measurement results + + + + + +
Edit measurement results + + - - - -
View QC results + + + + + +
Edit QC results + + - - - -
View calibration + + + - - -
View instrument data + + + - - -
View audit trail + + + - - -
Disinfection of the touch screen + + + + + +
Installation and put out of
+ + + - - -
operation
Switch off + + + + + +
Software update + + + - - -
Configuration + + + + - -
Configuration of security levels
+ - - - - -
and operator profiles
User service area + + + - - -
Export/import configurations + - - - - -
Export CSV + + + - - -
Troubleshooting + + + + + +
Remote lock + + + - - -
Send button + + - - - -
Cancel button + + + + + +
Set up QC materials + + + + - -
Table 10-1 cobas b 123 POC system operator profile settings
+ This function is enabled for this operator profile.

- This function is disabled for this operator profile.
Table 10-2 cobas b 123 POC system operator profile settings key
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p To create an operator
1 Utilities > Configuration > Operators
Figure 10-39 Operator settings screen
2 To create an operator, press the New button.

Figure 10-40 Creating operators screen
3 To enter the operator’s information, choose the corresponding parameter from

the drop-down list. Then, press the button. Enter your operator’s information
using the alphanumeric keyboard or dialog box that appears on the screen.
4 To add the operator to the system, press the OK button.
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Roche Diagnostics
p To edit an operator’s settings

2 To edit the operator’s settings, press the Edit button.

Figure 10-42 Editing operators screen
3 To edit the operator’s information, choose the corresponding parameter from the
drop-down list. Then, press the button. Enter your operator’s information
using the alphanumeric keyboard or dialog box that appears on the screen.
s
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p To delete an operator
2 Select the operator that you want to delete. Then, press the Delete button.
s
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Changing security levels
Security levels on the cobas b 123 POC system provide a defined set of instrument
functions that users can perform on their instruments. Each increased security level
disables more functions that the user can perform on the instrument.
Security levels Security off No security provided

Security level 1 Minimal security provided
Security level 2 Data security provided
Security level 3 Service security provided
Security level 4 Full security provided
Security off Security level 1 Security level 2 Security level 3 Security level 4
Measurement + + + + -
Edit operator during
+ + + + -
measurement
QC measurement + + + + -
Edit operator during QC
+ + + + -
measurement
Proficiency testing + + + - -
Calibration + + + - -
Calibration for “Ready” + + + + -
Consumable changes + + + + -
Remove QC lock + + + + -
View measurement results + + + + -
Edit measurement results + + - - -
View QC results + + + + -
Edit QC results + + - - -
View calibration + + + - -
View instrument data + + + - -
View audit trail + + + - -
Disinfection of the touch
+ + + + -
screen
Installation and put out of
+ + + - -
operation
Switch off + + + + -
Software update + + + - -
Configuration + + + - -
Configuration of security levels
+ - - - -
and operator profiles
User service area + + + - -
Export/import configurations + - - - -
Export CSV + + + - -
Troubleshooting + + + + -
Remote lock + - - - -
Send button + + - - -
Table 10-3 cobas b 123 POC system security level settings
Roche Diagnostics
Security off Security level 1 Security level 2 Security level 3 Security level 4
Cancel button + + + + -
Set up QC materials + + - - -
Table 10-3 cobas b 123 POC system security level settings
+ This function is available.

- This function is not available. You have to be an authorized user to perform this
function.
Table 10-4 cobas b 123 POC system security levels key
p To change the instrument’s security level
q Before changing the instrument’s security level, make sure that at least one user with the
supervisor user profile has been added to the system.
1 Utilities > Configuration > Security
Figure 10-44 Configuring the instrument security level screen
2 In the Instrument security level panel, select your desired security level.
s
Roche Diagnostics
Performing software and language updates
Performing software and language updates
Software and language updates add new and remove outdated features, deliver bug
fixes and update drivers to the software running the cobas b 123 POC system. Roche
recommends that you perform these updates as soon as you receive them from your
Roche representative.
Before performing a software or language update, move its associated files to your
USB storage device.
p To perform a software update

1 Instrument > Software update
Figure 10-45 Software update from USB storage device screen

s
p To perform a language update

1 Instrument > Language update
Figure 10-46 Language update from USB storage device screen

s
Roche Diagnostics
Exporting and importing configuration settings
Exporting and importing configuration settings
This feature allows you to efficiently import and export configuration settings
between different systems.
p To export configuration settings

1 Insert a USB storage device into the USB interface.
u To connect a USB storage device (p. 261)
2 Utilities > Export / import > Export configuration
4 Remove the USB storage device from the USB interface.
s
p To import configuration settings

1 Utilities > Export / import > Import configuration
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Roche Diagnostics
Audit trail
Audit trail
You can find all changes in instrument settings and input values in the audit trail.
To enter the audit trail, press the following buttons: Instrument > Audit trail.
q Audit trail is only available for users with the following user profile types: Supervisor, key
operator, service operator.
Figure 10-47 Audit trail
To sort audit trail entries by date and time or operator, press their respective column
headers.
p To export data to a storage device from the Audit trail

1 Instrument > Audit trail
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Audit trail
2 To add an audit trail entry for export, use the drop-down list to choose it. Then,
press the button.
Figure 10-49 Export to USB storage device screen
p To print out a report from the Audit trail

1 Instrument > Audit trail
2 To select an audit trail entry for printing, use the drop-down list to choose it.
Then, press the button.
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Roche Diagnostics
Available printout reports
Measurement report The measurement report displays input values and results for all measurements. It
can be configured to suit your needs.
Figure 10-51 Measurement report printout
Acid base report The acid base report is a graphical representation of a patient’s acid-base
physiological state based on the Henderson-Hasselbalch equation. pH and PCO2
measurements are used to identify acid-base physiology disorders, such as metabolic
and respiratory acidosis and alkalosis.
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Figure 10-52 Acid base report printout
Patient trending report The patient trending report shows trends for specific parameters in a patient over
time.
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Figure 10-53 Patient trending report printout
Proficiency test report The proficiency test report displays input values and results for proficiency tests.
These reports may be sent to the organizers of your interlaboratory comparison
scheme to assess your laboratory’s results.
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Figure 10-54 Proficiency test report printout
QC report The QC report displays input values and results for all QC measurements.
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Figure 10-55 QC report printout
Levey-Jennings report The Levey-Jennings report display QC statistics to help you identify errors in how the
system performs measurements.
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Figure 10-56 Levey-Jennings report printout
Sensor status report The sensor status report displays status information for all of the measuring
parameters on the instrument. This information is used to help identify specific
errors on the instrument that you cannot troubleshoot.
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Figure 10-57 Sensor status report printout
Roche Diagnostics
Consumable change
11 Consumable change ....................................................................................................................... 297

cobas b 123 POC system 11 Consumable change
Table of contents
Consumable change 11
This chapter describes the process of changing the consumables that enable the
proper operation of the instrument.

Disinfection procedures ................................................................................................... 299
Disinfecting the instrument............................................................................................. 301
Changing consumables..................................................................................................... 303
Additional information for consumable changes.......................................................... 307
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11 Consumable change cobas b 123 POC system
Table of contents
Roche Diagnostics
Disinfection procedures
Failure to follow disinfection procedures may result in infection

Failure to follow disinfection procedures may lead to contact with biohazardous materials,
WARNING which may result in infection.

o Lab gloves
o Lab coat
o Eye protection
r If biohazardous material comes into contact with your skin, wash the affected area
immediately with soap and water, and apply a disinfectant. Consult a physician.
Disinfection minimizes the risk of infection when replacing items that were in
contact with blood. Regularly perform these procedures.
Roche recommends adding a disinfection procedure to your standard laboratory
practices.
q Use only liquid surface disinfectants containing alcohol (approximately 70%), e.g.
isopropanol 70%, and/or disinfectants containing 0.5–1% dimethyl benzyl ammonium
chloride.
Do not use bleaching agents.
Roche recommends using these ready-to-use disinfectants:
Application
Name Sales manufacturer Active agent
time (min)
Incidin liquid(1) Ecolab GmbH & Co OHG Alcohols 5
B. Braun Medical AG Sales: B.
Meliseptol(2) Alcohol aldehyde 5
Braun Melsungen AG
(1) Incidin is a registered trademark of Ecolab GmbH & Co OHG.
(2) Meliseptol is a registered trademark of B. Braun Medical AG.
NOTICE Spraying disinfectant onto the instrument may damage the system
Spraying disinfectant onto the instrument may damage the system’s electronics.
r When using disinfectants, first spray the disinfectant onto a damp cloth. Then, wipe the
desired location with this cloth.
r Do not spray disinfectant on parts that cannot be removed, or that are inside the
instrument.
Roche Diagnostics
Immediate use after disinfection may lead to fire or explosion

Traces of disinfectant on the instrument after a disinfection may provoke a fire or
WARNING explosion.
r After disinfecting the instrument, allow the disinfectant to evaporate from the
instrument for 15 minutes.
Roche Diagnostics
Disinfecting the instrument
Regularly disinfect the following parts of the instrument:

o Touch screen
o Surfaces of the instrument (including all covers)
o Consumable area
p To disinfect the instrument’s screen

NOTICE Spraying water or disinfectant onto the screen may damage the instrument
Disinfecting the instrument’s screen by directly spraying water, disinfectants, or other
liquids may damage the instrument.
r When using liquids to disinfect the screen, first spray the liquid onto a damp cloth.
Then, wipe the desired location with this cloth.
r Do not directly spray any liquids onto the screen.
1 Instrument > Disinfection of touch screen

The touch screen is deactivated for 30 seconds.
2 Clean the screen with a damp cloth moistened with disinfectant.
s
p To disinfect the instrument’s surfaces

NOTICE Spraying disinfectant onto the instrument may damage the instrument
Spraying disinfectant onto the instrument may damage the instrument’s electronics.
instrument.
1 Clean all surfaces with a damp cloth moistened with disinfectant.

If there are locations that need more cleaning, clean these surfaces first with a
swab or cellulose sponge moistened with distilled water, and then clean with a
damp cloth moistened with disinfectant.

WARNING explosion.
2 Allow the disinfectant to evaporate from the surfaces for 15 minutes.

s
Roche Diagnostics
p To disinfect the instrument’s consumable area

Disinfecting the Sensor Cartridge or the measuring chamber module may lead to
incorrect patient results
WARNING Disinfecting the Sensor Cartridge or the measuring chamber module may deteriorate the
performance of the Sensor Cartridge’s sensors, which may lead to incorrect patient results.
r Do not disinfect the Sensor Cartridge or the measuring chamber module. Do not
disinfect any part that cannot be removed, or that are inside the instrument.
r Do not spray any water or disinfectants on the Sensor Cartridge, or inside the
measuring chamber module.
Displaced valve levers

Displaced valve levers cause problems when inserting the Fluid Pack.
CAUTION r During disinfection, be absolutely certain not to displace the valve levers.
NOTICE Disinfecting the consumables area with water or sprays may damage the
instrument’s electronics
Disinfecting the consumables area by directly spraying water, disinfectants, or other liquids
may damage the instrument’s electronics.
instrument.
q Disinfect the instrument’s consumable area as part of each consumable change and the
put out of operation routine. Do not disinfect the instrument’s consumable area at any
other time.
1 Clean the consumable area with a damp cloth moistened with disinfectant.
To protect the Sensor Cartridge and the hemolyzer, avoid disinfecting the left wall
of the consumable area. The left wall is the separation between the measuring
chamber and oximeter modules.
If there are locations that need more cleaning, clean these surfaces first with a
swab or cellulose sponge moistened with distilled water, and then clean with a
damp cloth moistened with disinfectant.

WARNING explosion.
2 Allow the disinfectant to evaporate from the surfaces for 15 minutes.

s
Roche Diagnostics
Changing consumables
p To change the Sensor Cartridge

Inappropriate handling and disposal of Sensor Cartridges may result in infection
and environmental harm
WARNING Sensor Cartridges may contain trace amounts of hazardous liquids. Inappropriate handling
of Sensor Cartridges may lead to direct exposure of these liquids, which may lead to
serious skin burns, eye damage, and other serious health risks. In addition, inappropriate
disposal may contaminate the environment.
r Treat used Sensor Cartridges as hazardous waste and dispose them according to local
regulations. For more information, contact your Roche Service representative.
r When handling and disposing Sensor Cartridges, prevent direct contact by wearing
o Lab gloves
o Lab coat
o Eye protection
r When handling Sensor Cartridges, keep them upright, with the inlet and outlet of the
Sensor Cartridge pointed upwards, to avoid spillage.
physician.
Sensor Cartridge exchange

r Perform QC measurements on 3 levels after each Sensor Cartridge exchange.
WARNING u Quality control (p. 179)
1 Workplace > Change Sensor Cartridge

q Before inserting a new Sensor Cartridge, disinfect the consumable area.

u To disinfect the instrument’s consumable area (p. 302)
q When inserting a new Sensor Cartridge, touch it by its handle only.
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p To change the Fluid Pack

Inappropriate handling and disposal of Fluid Packs may result in infection and
environmental harm
WARNING Fluid Packs may contain trace amounts of hazardous liquids. Inappropriate handling of
Fluid Packs may lead to direct exposure of these liquids, which may lead to serious skin
burns, eye damage, and other serious health risks. In addition, inappropriate disposal may
contaminate the environment.
r Treat used Fluid Packs as hazardous waste and dispose them according to local
r When handling and disposing Fluid Packs, prevent direct contact by wearing
o Lab gloves
o Lab coat
o Eye protection
r When handling Fluid Packs, keep them upright to avoid spillage.
r If contents from the Fluid Pack come into contact with your skin, wash the affected
area immediately with soap and water and apply a disinfectant. Consult a physician.
Exchanging a Fluid Pack

r Perform QC measurements on 3 levels after each Fluid Pack exchange.
WARNING u Quality control (p. 179)
q When removing the Fluid Pack, do not move its valves.
1 Workplace > Change Fluid Pack

q Before inserting a new Fluid Pack, disinfect the consumable area.

During disinfection, be absolutely certain not to displace the valves. Displaced valves
cause problems inserting the Fluid Pack.
q When inserting a new Fluid Pack, do not touch its cuvette or sample sensor contacts. If
the new Fluid Pack is not detected, check the smart memory chip on the rear side of
the Fluid Pack for dirt. If necessary, remove the dirt with a dry cloth.
Roche Diagnostics
p To change the AutoQC Pack

Inappropriate disposal of AutoQC Pack may cause environmental harm
Used AutoQC Packs may contain trace amounts of hazardous liquids. Inappropriate
WARNING disposal may result in infection and environmental harm.
r Treat used AutoQC Packs as biohazardous waste and dispose it according to the local
o Lab gloves
o Lab coat
o Eye protection
r If you spill contents from the AutoQC Pack, wipe it up immediately and apply a
disinfectant.
r If contents from the AutoQC Pack come into contact with your skin, wash the affected
area immediately with soap and water and apply a disinfectant. Consult a physician.
Removing the AutoQC Pack from the instrument may result in injury
Glass splinters from broken ampoules inside the AutoQC Pack may escape when you
CAUTION remove the AutoQC Pack. This may result in personal injury.
glasses.
r Prevent personal injury when handling and disposing AutoQC Packs by wearing
o Lab gloves
o Lab coat
o Eye protection
r Take extra care when working with protective gloves, which can easily be pierced or
cut, leading to personal injury.
Turning over an AutoQC Pack may result in spilled liquid

Reinstalling an AutoQC Pack that has been turned over may spill AutoQC material. In
CAUTION addition, glass splinters from broken QC ampoules may destroy the AutoQC module.
r If you plan on reinstalling a used AutoQC Pack, keep it in an upright position when it is
outside of the instrument.
r If liquid does spill from the AutoQC Pack, wipe it up immediately and apply a
NOTICE Inserting damaged AutoQC Packs may damage the instrument

If damaged AutoQC Packs are inserted into the cobas b 123 POC system, the AutoQC
module may become damaged.
r Before inserting AutoQC Packs into the instrument for the first time, check for possible
damage during transportation. If an AutoQC Pack shows evidence of damage, do not
insert it into the instrument.
Roche Diagnostics
q A new AutoQC Pack has to be adjusted to room temperature at least 24 hours before use.
1 Workplace > Change Auto QC Pack

q Before inserting a new AutoQC Pack, disinfect the consumable area.

p To change the printer paper
q The printer paper is heat-sensitive on one side only. Ensure that you insert the paper roll
correctly, with the heat-sensitive side up.
1 Workplace > Change printer paper

s
Roche Diagnostics
Additional information for consumable changes
Additional consumable changes At the end of a consumable change, you can perform additional changes for the other
consumables by pressing its respective button.
Figure 11-1 Additional consumable changes screen
To display the status of each consumable, press its respective Info button.
The color of the Info button represents its status:
Consumable does not need to be exchanged
Warning level for the consumable has been reached

The consumable has to be exchanged in the next 2 days.
Alarm level for the consumable has been reached
The consumable has to be exchanged immediately.
Displaying the consumable status To display the status of your instrument’s consumables, press the following buttons:
Instrument > Consumable status.
Roche Diagnostics
Figure 11-2 Consumable status window
To display the status of each consumable, press its respective tab in the window.
Unlocking the front door When you perform a Fluid Pack, a Sensor Cartridge or an AutoQC Pack change, you
are asked to open the front door. You have 30 seconds to open the front door. After
this time, the front door is automatically locked.
To unlock the front door, press the Unlock front door button.
Roche Diagnostics
Troubleshooting
12 Troubleshooting.............................................................................................................................. 311
cobas b 123 POC system 12 Troubleshooting
Table of contents
Troubleshooting 12
In this chapter, error messages that appear in the software, their causes and
troubleshooting actions are described.

Alarm area and buttons .................................................................................................... 314
System stops ....................................................................................................................... 316
Defects ................................................................................................................................ 320
Warnings............................................................................................................................. 321
Information alarms ........................................................................................................... 322
Status messages on the measurement report ................................................................. 323
Calibration and QC troubleshooting for parameters ................................................... 324
Calibrating sensor parameters that are not calibrated ........................................... 324
Calibrating oximeter parameters that are not calibrated ....................................... 324
Removing QC locks or warnings from sensor parameters.................................... 325
Removing QC locks or warnings from oximeter parameters ............................... 325
Performing Sensor Cartridge wetting routines ............................................................. 326
Checking the Fluid Pack valve positions........................................................................ 327
Barcode scanner troubleshooting ................................................................................... 328
Creating troubleshooting reports and log files.............................................................. 329
Depot repair ....................................................................................................................... 330
Roche Diagnostics
12 Troubleshooting cobas b 123 POC system
Table of contents
Roche Diagnostics
General information
General information
Infection and injury due to contact with used components

Contact with used components, such as Fluid Packs, AutoQC Packs, AutoCVC Packs, and
WARNING Sensor Cartridges, may lead to biohazardous contamination, resulting in personal injury
and/or infection.
r Treat these components as infectious waste. Dispose consumables according to the
local regulations. For more information, contact your Roche Service representative.
r Wear appropriate personal protective equipment, such as laboratory clothing,
protective gloves, safety glasses, face masks, and safety visors, during disposal to
prevent direct contact.
r Take extra care when working with protective gloves. They can easily be pierced or cut,
leading to infection.
r If waste comes into contact with your skin, wash the affected area immediately with
soap and water and apply a disinfectant. Consult a physician.
The system can monitor air bubbles, clots, leaks and blockages in the system. If your
system detects one of these issues, an error message appears as a system stop, module
stop, or status message.
Roche Diagnostics
Alarm area and buttons
Alarm button If there is an error, the Alarm button is activated and the alarm name is displayed.
The Alarm button changes color depending on the error type.
There are no warnings or errors on the system. The alarm screen is not
available.
There is information for you on the system. There are no interruptions to

operations or routines on the system, but there are pending actions for you to
complete.
There is a warning on the system. Normal operation of the system may be

limited.
There is an error on the system. You may not be able to perform specific
functions, or all functions, on the system until the error has been resolved.
Alarm screen When you press the Alarm button, the Alarm screen opens and displays details about
the cause of the warning or error, and possible troubleshooting actions.
Figure 12-1 Alarm screen
Alarm list The Alarm list is found at top of the Alarm screen. It shows the error type, ID and
message, and the date and time of the error.
! Type of error:
o SS = System stop
o D = Defect
o W = Warning
o I = Information
Roche Diagnostics
Date/Time Date and time of the error

Message Error description:
e.g., Fluid Pack Error
ID Error ID
Roche Diagnostics
System stops
System stops
A system stop is a critical error which stops the instrument. You cannot perform
measurements or calibrations during a system stop.
When a system stop occurs on the instrument, a system stop window with a red box
appears on the Overview tab. If the system stop is due to a consumable issue, a red bar
appears below the affected consumable.
The system stop window displays the following information:
Category (1) Type of error, e.g. Fluid Pack Error

Cause Fluid Pack exhausted or expired
Corrective Action Change Fluid Pack
(1) Category information is not displayed for expected systems stops due to normal operation, such as an
empty Fluid Pack, or Sensor Cartridge with no remaining tests.
Figure 12-2 System stop window
To remedy a system stop, follow the instructions on the screen.
If you have to resolve a system stop and it is not listed, contact your Roche Service
representative.
WARNING
ID Category Cause Type of error Action

1 Instrument error Analyzer defective AutoQC system stop o Press the Shutdown system button.
o Turn on the instrument again.
o If this error persists, contact your Roche Service
representative.
2 Instrument error Internal control Microcontroller system o Press the Restart system button.
module not stop o If this error persists, contact your Roche Service
responding representative.
3 Fluid Pack error Fluid Pack defective SIM system stop o Press the Change Fluid Pack button.
representative.
Table 12-1 System stops
Roche Diagnostics
System stops

4 Fluid Pack error Fluid Pack defective Sample sensor system o Press the Change Fluid Pack button. Follow the
stop instructions on the screen.
representative.
5 Fluid Pack error Fluid Pack defective Valve system stop o Press the Change Fluid Pack button. Follow the
instructions on the screen.
representative.
6 Fluid Pack error Fluid Pack defective System stop due to o Press the Change Fluid Pack button. Follow the
washing error instructions on the screen.
representative.
7 Fluid Pack error Fluid Pack defective System stop due to o Perform an internal wetting routine: Utilities
insufficient filling with > Sensor Cartridge internal wetting routine
reference solution o Remove and reinstall the Sensor Cartridge:
Workplace > Change Sensor Cartridge
o If this error persists, remove and reinstall the
Fluid Pack: Workplace > Change Fluid Pack
o If this error still persists, contact your Roche Service
representative.
8 Fluid Pack error Fluid Pack defective System stop due to o Press the Change Fluid Pack button. Follow the
empty system instructions on the screen.
representative.
positioning of solution > Sensor Cartridge internal wetting routine
o Remove and reinstall the Sensor Cartridge:
representative.
positioning of sample > Sensor Cartridge internal wetting routine
o Remove and reinstall the Sensor Cartridge:
representative.
11 Operator cancel Operator canceled o Press the Accept button.
action o If this error persists, contact your Roche Service
representative.
12 Instrument error Analyzer defective Valves hardware defect o Press the Shutdown system button.
representative.
13 Sensor Cartridge Sensor Cartridge Filling of o Press the Change Sensor Cartridge button. Follow
error defective Sensor Cartridge not the instructions on the screen.
possible o If this error persists, contact your Roche Service
representative.
14 Instrument error Analyzer defective Measuring chamber o Press the Shutdown system button.
module defective o Turn on the instrument again.
representative.
Roche Diagnostics
System stops

15 Instrument error Analyzer defective Fluidics control board o Press the Shutdown system button.
defective o Turn on the instrument again.
representative.
16 Instrument error Analyzer defective Oximeter module board o Press the Shutdown system button.
defective o Turn on the instrument again.
representative.
17 Instrument error Analyzer defective UIM hardware/power o Press the Shutdown system button.
supply defective o Turn on the instrument again.
representative.
18 Sensor Cartridge Sensor Cartridge o Press the Change Sensor Cartridge button. Follow
error dirty the instructions on the screen.
o Inspect the rear side of the Sensor Cartridge for dirt.
Remove any dirt with a dry cloth.
o Reinstall the Sensor Cartridge.
o If this error persists, remove the Fluid Pack:
Workplace > Change Fluid Pack
o Inspect the docking parts of the Fluid Pack for dirt.
Remove any dirt with a moist cloth.
o Reinstall the Fluid Pack.
representative.
19 Fluid Pack error Fluid Pack defective Fluidics tightness o Press the Change Fluid Pack button. Follow the
problem instructions on the screen.
representative.
20 Fluid Pack error Fluid Pack defective Fluidics system blocked o Press the Change Fluid Pack button. Follow the
representative.
21 Instrument error Spare part not Unknown μC board o Press the Restart system button.
initialized o If this error persists, contact your Roche Service
representative.
22 Instrument error Spare part not EEPROM data o Press the Restart system button.
compatible conversion error o If this error persists, contact your Roche Service
representative.
23 Instrument error Analyzer defective μC power connection o Press the Shutdown system button.
error o Turn on the instrument again.
representative.
24 Sensor Cartridge Sensor Cartridge Read/write chip error o Press the Change Sensor Cartridge button. Follow
chip chip error the instructions on the screen.
communications o Inspect the Sensor Cartridge chip for dirt. Remove
error any dirt with a dry cloth.
o Reinstall the Sensor Cartridge.
representative.
Roche Diagnostics
System stops

25 Fluid Pack chip Fluid Pack chip error Read/write chip error o Press the Change Fluid Pack button. Follow the
communications instructions on the screen.
error o Inspect the Fluid Pack chip for dirt. Remove any
dirt with a dry cloth.
o Reinstall the Fluid Pack.
representative.
1000 Instrument error Internal software Database server not o Press the Restart system button.
error started o If this error persists, contact your Roche Service
representative.
1001 Sensor Cartridge Power fail during o Remove and reinstall the Sensor Cartridge: Press
error Sensor Cartridge the Change Sensor Cartridge button and follow
change the instructions on the screen.
representative.
1002 Sensor Cartridge Exhausted or expired Sensor Cartridge invalid o Press the Change Sensor Cartridge button. Follow
error the instructions on the screen.
representative.
1003 Fluid Pack error Exhausted or expired Fluid Pack invalid o Press the Change Fluid Pack button. Follow the
representative.
1004 Instrument error Internal software Scheduler timeout o Press the Restart system button.
error o If this error persists, contact your Roche Service
representative.
1005 Timeout Sample container not o Remove the capillary. Press the Capillary removed
removed button.
representative.
1006 Timeout Sample container not o Remove the syringe. Press the Syringe removed
removed button.
representative.
1007 Instrument error Memory card cannot o Insert a valid memory card:
be accessed o CF card for hardware version 1
o SD card for hardware version 2
o Press the Shutdown system button.
representative.
1008 Instrument error Software update Software version o Press the Restart system button.
failed mismatch o If this error persists, contact your Roche Service
representative.
1009 Instrument error Internal software Data synchronization o Press the Restart system button.
error error on memory card o If this error persists, contact your Roche Service
representative.
1010 Instrument error Internal software Database corrupted o Press the Shutdown system button.
error o Turn on the instrument again.
representative.
Roche Diagnostics
Defects
Defects
Defects are module-specific issues that do not affect the operation of the instrument.
You can perform measurements, but you may not be able to perform specific
functions if it involves the affected module.
To remedy a defect, follow the instructions on the screen.
q If you have to resolve a defect and it is not listed, contact your Roche Service
representative.
ID Category Cause Action

3000 AutoQC Pack error Exhausted or expired o Press the Change AutoQC Pack button. Follow the
representative.
3001 AutoQC module error AutoQC module defective o Press the AutoQC recovery button. Follow the
o Install a new AutoQC Pack.
representative.
3002 Oximeter module error Oximeter module defective o Press the Shutdown system button.
representative.
3003 Printer module error Printer module defective o Press the Shutdown system button.
representative.
3004 Printer module error No printer paper o Press the Change printer paper button. Follow the
3005 AutoQC Pack error AutoQC Pack defective o Press the Change AutoQC Pack button. Follow the
representative.
3006 AutoQC Pack chip AutoQC Pack chip error o Press the Change AutoQC Pack button. Follow the
communication error instructions on the screen.
o Inspect the AutoQC Pack chip for dirt. Remove any
dirt with a dry cloth.
o Reinstall the AutoQC Pack.
representative.
Table 12-2 Defects
Roche Diagnostics
Warnings
Warnings
Warnings are advance notifications of possible issues with the instrument or

consumables. You can perform measurements, but you may not be able to perform
specific functions if it involves the affected module of the instrument or the
consumable.
To remedy a warning, follow the instructions on the screen.
q If you have to resolve a warning and it is not listed, contact your Roche Service
representative.

5000 Fluid Pack warning Critical fill level in Fluid Pack o Press the Change Fluid Pack button. Follow the
representative.
5001 Fluid Pack warning Fluid Pack nearly expired o Press the Change Fluid Pack button. Follow the
representative.
5002 AutoQC Pack warning Critical fill level in AutoQC Pack o Press the Change AutoQC Pack button. Follow the
representative.
5003 AutoQC Pack warning AutoQC Pack nearly expired o Press the Change AutoQC Pack button. Follow the
representative.
5004 Sensor Cartridge warning Total number of tests close to limit o Press the Change Sensor Cartridge button. Follow
the instructions on the screen.
representative.
5005 Sensor Cartridge warning Sensor Cartridge nearly expired o Press the Change Sensor Cartridge button. Follow
the instructions on the screen.
representative.
5006 Temperature warning Temperature range exceeded o Press the Restart system button.
representative.
5007 Instrument warning Magnetic switch defective o Contact your Roche Service representative.
Table 12-3 Warnings
Roche Diagnostics
Information alarms
Information alarms
Information alarms refer to actions that you have to perform. You can perform all
functions with the instrument while information alarms are active.
To remedy an information alarm, follow the instructions on the screen.
q If you have to resolve an information alarm and it is not listed, contact your Roche Service
representative.

7000 Service action Deleting of instrument database o To remove all data and configurations from the
requested instrument database, press the Restart system
button.
o To abort the request, press the Cancel button.
7001 Service action Software update pending o To install the software update, press the
Restart system button.
o To abort the software update, press the Cancel
button.
7002 Service action Configuration file pending o To apply the new configuration, press the
Restart system button.
o To abort the request, press the Cancel button.
Table 12-4 Information alarm
Roche Diagnostics
Status messages on the measurement report
Status messages on the measurement report
Status messages appear on measurement reports to provide you additional

information about your measurement result, or to explain why a measurement result
could not be determined.
Messages Explanation
(c) Correlation factors have been applied to this measurement result.
(q) This measurement result was determined by a parameter with a QC warning.
Base value not available Calculated value cannot be determined because an input value or measurement result is missing
or not available.
Hemolysis error Hemolysis cycle could not be successfully performed during the COOX measurement.
Improper sample type Measurement was attempted to be performed with an improper sample type.
Inhomogeneous sample Sample was not properly mixed before performing the measurement.
Insufficient volume Sample volume was not sufficient to measure the activated parameters.
Measurement in progress Measurement is still in progress and the result is not yet available.
Not calibrated Parameter was not calibrated before performing the measurement.
Operator cancel You have canceled the measurement before the results are available.
Spectral interference / Considerable percentage of the detected signal at the oximeter module comes from an interfering
Interference error substance. Results may be compromised.
Value above... Result is above the upper limit of the measuring range or the AMR.
Value below... Result is below the lower limit of the measuring range or the AMR.
Signal distorted Considerable percentage of the detected signal comes from an interfering substance.
Range error Calibration value is outside of the measuring range or the AMR.
Insufficient sample Air bubbles were aspirated while performing the measurement.
Slope error Result is outside of the measuring range or the AMR.
Linearity error Result is outside of the measuring range or the AMR.
Table 12-5 Status messages on the measurement report
Roche Diagnostics
Calibration and QC troubleshooting for parameters
Before troubleshooting calibration and QC errors on the instrument, identify the

affected parameters, and in which category each affected parameter belongs to.
The following table shows which parameters belong to the sensor and oximeter
parameter categories.
Sensor parameters (BG - ISE - Glu - Lac)

The sensor parameters include the following parameters:
o pH o Na+ o Glu
o PCO2 o K+ o Lac
o PO2 o Ca2+
o Hct o Cl–
Oximeter parameters (tHb - COOX)
The oximeter parameters include the following parameters:
o tHb
o COOX (including COHb, MetHb, O2Hb, HHb, SO2 and bilirubin)
Calibrating sensor parameters that are not calibrated
If one or more sensor parameters are not calibrated, perform the following
procedure.
p To calibrate sensor parameters that are not calibrated

1 To perform the Calibration for Ready, press Instrument
> Calibration for Ready.
2 Carry out the internal wetting routine.
Press Utilities > Sensor Cartridge internal wetting routine to call up the wetting
routine:
Call up another Calibration for ready.
s
Calibrating oximeter parameters that are not calibrated
If one or more oximeter parameters are not calibrated, perform the following
procedure.
p To calibrate oximeter parameters that are not calibrated

1 To perform the oximeter calibration, press the following buttons: Instrument
> Oximeter calibration.
s
Roche Diagnostics
Removing QC locks or warnings from sensor parameters
If one or more sensor parameters have a QC lock or warning, perform the following
procedure.
p To remove a QC lock or warning from sensor parameters

1 To perform a manual QC measurement, press the following buttons: Workplace
> QC measurement.
2 If this error persists, perform a system calibration. Press the following buttons:
Instrument > System calibration.
3 Perform a manual QC measurement. Press the following buttons: Workplace
> QC measurement.
4 To perform a Sensor Cartridge internal wetting routine, press the following
buttons: Utilities > Sensor Cartridge internal wetting routine.
5 To perform a system calibration, press the following buttons: Instrument
> System calibration. Then, perform a manual QC measurement by pressing the
following buttons: Workplace > QC measurement.
6 If this error still persists, contact your Roche Service representative.
s
Removing QC locks or warnings from oximeter parameters
If one or more oximeter parameters have a QC lock or warning, perform the

following procedure.
p To remove a QC lock or warning from oximeter parameters

1 To perform a manual QC measurement, press the following buttons: Workplace
> QC measurement.
2 If this error persists, perform an oximeter calibration. Press the following buttons:
Instrument > Oximeter calibration.
3 Perform a manual QC measurement. Press the following buttons: Workplace
> QC measurement.
4 To remove the Fluid Pack, press the following buttons: Workplace
> Change Fluid Pack. Then, follow the instructions on the screen.
5 Reinstall the Fluid Pack. Then, perform a manual QC measurement by pressing
the following buttons: Workplace > QC measurement.
6 If this error still persists, contact your Roche Service representative.
s
Roche Diagnostics
Performing Sensor Cartridge wetting routines
Performing Sensor Cartridge wetting routines
To activate the internal contents of the Sensor Cartridge, the system performs an
automatic internal wetting routine each time you insert a new Sensor Cartridge.
p To perform an internal wetting of the Sensor Cartridge

1 Utilities > Sensor Cartridge internal wetting routine
A 2P calibration is automatically performed at the end of the internal wetting.
s
p To perform an external wetting of the Sensor Cartridge

Incorrect results due to using inappropriate wetting fluids
Performing an external wetting routine without using a whole blood sample may lead to
WARNING incorrect patient results, which may endanger patient lives.
r Use only whole blood samples to perform the external wetting routine. Whole blood
samples have to be collected within the last 24 hours, and use heparin as an
anticoagulant.
q When you perform the external wetting routine in syringe mode, the minimum sample
volume is 1 mL in a 2 mL syringe.
When you perform the external wetting routine in capillary mode, the minimum sample
volume is 180 μL.
1 Prepare a whole blood sample for the wetting.

2 Utilities > Sensor Cartridge wetting routine
3 Select one of the following options:
o If the whole blood sample is in a syringe, press the Syringe: start wetting
button.
or,
o If the whole blood sample is in a capillary, press the Capillary: start wetting
button.
5 To perform a Calibration for Ready, press the following buttons: Instrument
> Calibration for Ready
s
Roche Diagnostics
Checking the Fluid Pack valve positions
Checking the Fluid Pack valve positions
The Fluid Pack valve positions can change when removing and reinstalling
Fluid Packs into the system. Before you reinstall a Fluid Pack into the system, make
sure that all of the valves are in the correct position.
A Correct valve positions B Third valve in the incorrect valve position (circled)
Figure 12-3 Fluid Pack valve positions
p To move a displaced Fluid Pack valve

Inappropriate handling of the Fluid Pack during troubleshooting may result in
infection
WARNING The Fluid Pack may contain liquid and/or solid waste. Inappropriate handling of the
Fluid Pack during troubleshooting may lead to biohazardous contamination, resulting in
personal injury and/or infection.

o Lab gloves
o Lab coat
o Eye protection
r If waste comes into contact with your skin, wash the affected area immediately with
soap and water an apply a disinfectant. Consult a physician.
1 Insert the tip of a pen into the valve hole, and move the valve into its correct
position.
u Fluid Pack valve positions (p. 327)
2 Reinstall the Fluid Pack.
s
Roche Diagnostics
Barcode scanner troubleshooting
Barcode scanner troubleshooting
If you are having issues with your barcode scanner, follow the steps below:
p To find possible issues with your barcode scanner

1 Verify that your barcode scanner is securely connected to the interface connector
of the instrument.
u Interfaces: Hardware version 1 (p. 35)
2 Verify that there is an LED light visible inside the barcode scanner.
3 If your issues still persist, contact your Roche Service representative.
s
Roche Diagnostics
Creating troubleshooting reports and log files
Creating troubleshooting reports and log files
Troubleshooting reports and log files allow your Roche Service representative to
assess and solve errors that appear on your system.
p To create a troubleshooting report

1 Utilities > Export / import > Export Troubleshooting-Report
Figure 12-4 Creating the Troubleshooting-Report screen

s
p To create a log file

1 Utilities > Export / import > Export log files
Figure 12-5 Exporting log files screen
2 To set the time range for the log file, press the button in the Date from: and
Date to: fields. Then, press the Start export to USB button.
s
Roche Diagnostics
Depot repair
Depot repair
q Before sending your instrument for depot repair, put the instrument out of operation. Make
sure that there are no consumables in the instrument.
u Put out of operation (p. 134)
Depot repair allows you to exchange your defective system for a replacement
cobas b 123 POC system while it is being repaired. This service is only available in
selected countries. Contact your Roche Service representative for more information.
Roche Diagnostics
Appendix
13 Available accessories and consumables ......................................................................................... 333

14 Copyright information................................................................................................................... 339
15 Glossary .......................................................................................................................................... 343
cobas b 123 POC system 13 Available accessories and consumables
Table of contents
Available accessories and consumables 13
In this chapter, all available accessories and consumables, and their order numbers
are listed.

Available accessories and consumables .......................................................................... 335
Sensor Cartridge types ............................................................................................... 335
Fluid Pack types........................................................................................................... 335
QC material.................................................................................................................. 336
Accessories ................................................................................................................... 336
Roche Diagnostics
13 Available accessories and consumables cobas b 123 POC system
Table of contents
Roche Diagnostics
Available accessories and consumables
Below is a list of globally available accessories and consumables. For ordering

information, contact your Roche Service representative.
Sensor Cartridge types
Parameter
Cl- Na+ K+ Ca2+ PCO2 PO2 pH Hct tHb SO2 COOX Glu Lac
cobas b 123 Sensor Cartridge BG
(1) 05170397001 - - - - X X X X + + + - -
cobas b 123 Sensor Cartridge

X X X X X X X X + + + - -
BG/ISE(1) 05170460001
X X X X X X X X + + + X -
BG/ISE/Glu(1) 05331781001
X X X X X X X X + + + X X
BG/ISE/Glu/Lac(2) 05170478001
Table 13-1 Sensor Cartridge types
(1) up to 28 days or up to 700 tests
(2) up to 21 days or up to 500 tests
- Parameter is not measured

X Parameter is measured
Parameter is measured via the oximeter module. Only possible for
+ cobas b 123 <3> POC system and cobas b 123 <4> POC system together with one of
the cobas b 123 Fluid Pack COOX types
Table 13-2 Sensor Cartridge types table key
Fluid Pack types
Parameter
cobas b 123 Fluid Pack COOX 200(1) X X X X X X X X X X X X X

05169992001
05170036001
05170052001
cobas b 123 Fluid Pack 200(1) X X X X X X X X - - - X X
05403308001
05403154001
05403286001
Table 13-3 Fluid Pack types
Roche Diagnostics
(1) This Fluid Pack can be used for up to 200 tests or up to 42 days.
X Parameter is available (depending on the used Sensor Cartridge type)

- Parameter is not available
Table 13-4 Fluid Pack types table key
QC material
Parameter
cobas b 123 AutoQC Pack Tri-
+ + + + + + + + + + + + +
Level 05169933001
cobas b 123 AutoCVC Pack
+ + + + + + + + + + + + +
05231183001
COMBITROL PLUS B Level 1
O O O O O O O O O O O O O
03321193001
03321207001
03321215001
Table 13-5 QC material types
+ Only for cobas b 123 <2> POC system and cobas b 123 <4> POC system
O For all cobas b 123 POC system instruments
Table 13-6 QC material table key
Accessories
Parameter
cobas b 123 Printer Paper
05082595001
Adapter for Capillaries
03069931001
Ampoule Adapter 03066762001 O O O O O O O O O O O O O
Adapter for Sample Containers
03112101180
Clot Catcher(1) 03112012180 O O O O O O O O O O O O O
Clot Catcher PRO(1) O O O O O O O O O O O O O

05689856001
Caps for Roche
MICROSAMPLER 03112152180
Table 13-7 Accessories
Roche Diagnostics
Parameter
Roche MICROSAMPLER PROT
ECT, sterile 05772583001 (50 O O O O O O O O O O O O O
pcs.)
Hypodermic needle
09251561001 (100 pcs.)
BS2 Blood Sampler 03113493035
(MC0028)
Capillary Tubes, ~ 200 μL
03113477180 (MC0024)
Capillary Tubes, ~ 115 μL
03113507035 (MG0002)
Caps for Capillary Tubes
03113647035 (RE0410)
Table 13-7 Accessories
(1) Not suitable for measurements in syringe mode.
O Can be used.
Table 13-8 Accessories table key
Roche Diagnostics
Roche Diagnostics
cobas b 123 POC system 14 Copyright information
Table of contents
Copyright information 14

Software license information ........................................................................................... 341
Roche Diagnostics
14 Copyright information cobas b 123 POC system
Table of contents
Roche Diagnostics
cobas b 123 POC system 14 Copyright information
Software license information
cobas b 123 POC system software The cobas b 123 POC system software is protected by contract law, copyright laws,
and international treaties. The cobas b 123 POC system software is licensed for use
between F. Hoffmann-La Roche Ltd and a licensee, and only users authorized there
under are permitted to access and use the software. Unauthorized use and
distribution may result in civil and criminal penalties.
Open Source and Third Party Portions of the cobas b 123 POC system software include one or more open source
software or other third party software programs. For notices, copyright, and licensing terms
regarding open source or other third party software programs included in the
cobas b 123 POC system software, see section Third Party Licenses and License
Notifications within the cobas b 123 POC system software. References to “software”,
“Software”, “Program”, or “program” refer to the applicable open source or other
third party software program. These terms and notices do not apply to the
proprietary cobas b 123 POC system software.
Third party packages o Qt GUI Toolkit - GNU LESSER GENERAL PUBLIC LICENSE Version 2.1
o Firebird RDBMS - INTERBASE PUBLIC LICENSE. Initial Developer's PUBLIC
LICENSE Version 1.0
o QuaZIP - GNU LESSER GENERAL PUBLIC LICENSE Version 2.1
o DejaVu TrueType-Fonts - see copyright notice
o FireFlySung TrueType-Font - ARPHIC PUBLIC LICENSE
o Sazanami TrueType-Font - see copyright notice
The source code of the open source software can be requested on a standard data
exchange medium from the following address:
Roche Diagnostics International Ltd., Forrenstrasse 2, 6343 Rotkreuz, Switzerland
Roche Diagnostics
14 Copyright information cobas b 123 POC system
Roche Diagnostics
1P - Information alarm
Glossary 15
cobas b 123 AutoQC Pack Consumable containing
QC materials in ampoules that is inserted into the
1P 1-point calibration: an automatic calibration of AutoQC module for cobas b 123 <2> POC system and
sensor parameters using CAL1 solution. cobas b 123 <4> POC system variants. It allows for the
automatic controlling of BG, ISE, Glu, Lac, and
2P 2-point calibration: an automatic calibration of all
COOX/Bilirubin parameters.
parameters using CAL1, CAL2, and standby solutions of
different concentrations. Alternatively, cuvette layer cobas b 123 Fluid Pack Consumable containing all
thickness can also be calibrated. operating fluids, 2 waste bags, a sample input module, a
cuvette for the oximeter module (optional), and tubing
Acid base map A graphical representation of acid-
for the 2 peristaltic pumps and valves.
base physiology in a patient based on the Henderson-
Hasselbalch equation. pH and PCO2 measurements are cobas b 123 Sensor Cartridge Consumable
used to identify acid-base physiology disorders, such as containing a thick-film sensor that is used to translate
metabolic and respiratory acidosis and alkalosis. electrochemical and electrical signals from samples into
measurement values for BG, ISE, Glu, and Lac
Alkaline Basic, or a solution, whose pH value is greater parameters.
than 7.
COMBITROL PLUS B QC material for controlling BG,
AMR Range of values that an instrument can report ISE, Glu, Lac, COOX/Bilirubin in manual QC
directly without diluting or increasing the concentration measurements.
of a sample.
CVC Control materials that help assess whether the
Arate The assisted breathing rate when a patient is on a instrument is accurately measuring values throughout
ventilator. the measuring range.
Arterial blood Blood taken from the artery. Defects Module-specific issues that do not affect the
AutoQC module A unit that automatically takes QC operation of the instrument. You can perform
measurements programmed by the user. measurements, but you may not be able to perform
specific functions if it involves the affected module.
Barcode scanner Hand-held scanner with integrated
decoder for simple input of QC and electrode data, and Depot repair Allows you to exchange your defective
patient and operator information. system for a replacement system while it is being
repaired. This service is only available in selected
BG sensors Part of the cobas b 123 Sensor Cartridge. countries.
They measure pH, PO2, PCO2 and Hct parameters.
Fill port Enables a sample to be aspirated from syringes,
Bilirubin Yellow decomposition product of the red capillaries, ampoule adapters, and
blood pigment, hemoglobin. Roche MICROSAMPLER PROTECT.
Calibration for Ready A calibration type that brings Glu/Lac sensors Part of the
all activated parameters into the “Ready” state. cobas b 123 Sensor Cartridge. They measure glucose and
Clot Catcher Coagulum catcher for use with capillaries lactate parameters..
and Roche MICROSAMPLER PROTECT. Hematocrit The ratio of blood cell volume (mainly
Clot Catcher PRO Coagulum catcher for use with from red blood corpuscles) to the total blood volume.
syringes. Hemoglobin Main component of erythrocytes and
cobas b 123 AutoCVC Pack Consumable serves for transporting oxygen.
containing CVC materials in ampoules that is inserted Hemolyzer It applies a strong ultrasound field to
into the AutoQC module for samples to destroy the cell membranes of erythrocytes.
cobas b 123 <2> POC system and This releases hemoglobin for analysis.
cobas b 123 <4> POC system variants. It helps to assess
whether the instrument is accurately measuring values Heparin salts The only permitted anticoagulant for
throughout the measuring range. use with the system.
Information alarm Actions that you have to perform.
You can perform all functions with the instrument while
information alarms are active.
Roche Diagnostics
Instrument tab - START-UP phase
Instrument tab Location on the user interface where Plasma Liquid part of blood that contains water, salts,
you can manually start calibrations and disinfection enzymes, antibodies and other proteins. Plasma samples
tasks, and view the instrument, consumable and are collected by centrifuging heparinized whole blood.
parameter status.
Polychromator Light is refracted and focused onto the
IN-USE time Time from the beginning of the RUN-IN surface of a photosensitive receiver (CCD).
phase until the end of the stable phase
Printer A low-noise thermal printer, which is part of
ISE sensors Part of the cobas b 123 Sensor Cartridge. the user interface module.
They measure Na+, K+, Ca2+ and Cl- parameters. Proficiency test Monitors the continuing
Levey-Jennings graph Illustrates QC statistics to find performance of a laboratory to provide accurate results
errors in how the system performs measurements. in an interlaboratory comparison scheme. The
organizers send homogeneous materials to each of the
Measuring chamber module Controls the contact of participating laboratories, who analyze the material and
the Sensor Cartridge with the Fluid Pack and controls report their results to the organizers. The organizers
the temperature of the Sensor Cartridge. assess the results and notify the participating laboratories
Micro mode Sample mode for capillary measurements of the results.
that is automatically used when the instrument detects Quality control, QC A process used to verify that an
sample volumes less than 123 μL. instrument’s output is not affected by issues with the
Multirules Decision criteria used for determining instrument. This is done by measuring a certified sample
whether a parameter falls inside or outside of the with the instrument, and testing the results against the
specified range for a quality control run. It is based on sample’s specifications.
Westgard rules. Recalibration An automatic calibration performed
NIST standards Defines precise sera with certified after each measurement with standby solution.
expected values. RiliBÄK Guidelines of the German Federal Medical
Overview tab Main tab of the user interface. You can Council for quality assurance of test results in medical
start measurements, and view results, operating laboratories. They determine the minimum quality
instructions, alarms, warnings, and other general requirements for medical laboratory tests.
information on this screen. RUN-IN phase It begins after the START-UP phase
Oximeter calibration Oximeter module-specific and continues for a specific time, which is defined on the
calibrations performed during 2P and system Sensor Cartridge. During the RUN-IN phase, you can
calibrations on cobas b 123 <2> POC system and perform measurements without any impact to their
cobas b 123 <4> POC system variants. Consists of the accuracy or precisions, but sample measurement times
wavelength calibration of the polychromator, the are longer.
calibration of the intergration time and layer thickness Sample sensor contacts The electrical interface
calibration of the cuvette. between the Fluid Pack and the measuring chamber
Oximeter module Consists of the hemolyzer and the module.
COOX measuring chamber. It is an optical sensor Sensor parameters Parameters that are measured
module for determining total hemoglobin (tHb), using the Sensor Cartridge. These parameters are pH,
hemoglobin derivatives, and bilirubin (Bili).
PCO2, PO2, Hct, Na+, K+, Ca2+, Cl-, Glu and Lac.
Oximeter parameters Parameters that are measured
with the oximeter module. These parameters are tHb, Srate The spontaneous breathing rate when a patient is
COHb, MetHb, O2Hb, HHb, SO2, and bilirubin. on a ventilator.
Stable phase It begins at the end of the RUN-IN phase
Patient trend map Software feature in the system that
and ends when the in-use time of the Sensor Cartridge
is designed to graphically show trends in patient results
expires.
over time.
START-UP phase The first phase of the
Peristaltic pump Responsible for transporting sample
Sensor Cartridge after it is installed on the system.
and operating fluids in the system. 1 or 2 peristaltic
During the START-UP phase, the system performs
pumps are found on the system, depending on its
actions on the Sensor Cartridge to prepare it for its first
configuration. The tubing of the peristaltic pumps are
measurement.
part of the Fluid Pack.
Roche Diagnostics
System calibration - Workplace tab
System calibration Consists of the wavelength

calibration of the polychromator (optional), calibration
of the oximeter module lamps (optional), cuvette layer
thickness calibration (optional), O2 air calibration, the
determining of the O2 value of the standby solution, and
the 2-point calibration of all of the parameters. It is
performed every 24 hours.
System stop Critical error which stops the instrument.
You cannot perform measurements or calibrations
during a system stop.
Tonometered whole blood Whole blood is set with
the aid of precision gas to expected values to be
calculated for PO2 and PCO2.
Tonometry Modifying PO2 and PCO2 partial pressures
in a fluid using precision gas.
Troubleshooting report User-generated report of
errors that the user cannot successfully troubleshoot on
the system. It is intended to help Roche Service
representatives assess and solve these errors.
Utilities tab Location on the user interface where you
can perform installation, put out of operation and
shutdown procedures, software updates, system
configurations and export and import of troubleshooting
information.
Warnings Advance notifications of possible issues with
the instrument or consumables. You can perform
measurements, but you may not be able to perform
specific functions if it involves the affected module of the
instrument or the consumable.
Workplace tab Location on the user interface where
you can start consumable changes, perform QC and
CVC measurements, and view databases.
Roche Diagnostics
Workplace tab - Workplace tab
Roche Diagnostics
Index
Index ............................................................................................................................................... 349

cobas b 123 POC system Index
Index
Numerics – Specifications, 90
– Troubleshooting, 328
1P calibration, 225 Barcode scanner assignments, 36
2P calibration, 225
C
A
Calibration, 221
Abbreviations, 10 – 1P calibration, 225
Accessories – 2P calibration, 225
– Instrument, 30 – Automatic calibrations, 225
– Sample collection containers, 142 – Calibration database, 229
Acid base map, 176 – Calibration for "Ready", 228
Action buttons, 247 – Calibration intervals, 83
Alarm area and buttons, 314 – Calibration principle, 113
AMR – Calibration schemes, 223
– Configuration, 241 – Configuring calibration settings, 230
Anticoagulants, 140 – General information, 223
Assigning a correlation factor to a parameter, 122 – Oximeter calibration, 226
Assigning reference and critical ranges, 118 – PO2 calibration, 225
Assigning unit formats to parameters, 95 – Recalibration, 226
Audit trail, 286 – Standby calibration, 226
Automatic calibrations – Standby shifting, 226
– 1P calibration, 225 – System calibration, 225
– 2P calibration, 225 – User-activated calibrations, 228
– Monitoring, 226 Calibration database, 229
– Oximeter calibration, 226 Calibration for "Ready", 228
– PO2 calibration, 225, 226 Calibration principle, 113
– Standby calibration, 226 Calibration schemes, 223
– Standby shifting, 226 Calibration troubleshooting for parameters, 324
– System calibration, 225 Calibration verification control, 233
– Wash cycle, 227 – AutoCVC measurements, 238
AutoQC measurements, 184 – Configuring AMRs, 241
AutoQC Pack, 49 – CVC results in the QC database, 240
– Consumable change, 305 – General information, 235
– Types, 50 – Installing AutoCVC Packs, 236
Available accessories and consumables, 333 Capillary tubes, 142
– Accessories, 336 Changing printer paper, 306
– Fluid Pack, 335 Checking Fluid Pack valve positions, 327
– QC materials, 336 Clot Catcher, 142
– Sensor Cartridge, 335 Clot Catcher PRO, 143
Available printout reports, 288 Comparison of micro samples to normal samples, 78
– Acid base report, 288 Configuring AMRs, 241
– Levey-Jennings report, 292 – Adding new AMRs, 241
– Measurement report, 288 – Editing new AMRs, 242
– Patient trending report, 289 Configuring calibration settings, 230
– Proficiency test report, 290 – Activating automatic printing of calibration reports,
– QC report, 291 231
– Sensor status report, 293 – Defining daily frequency of 2P calibrations, 231
– Defining start times for system calibrations, 230
Configuring measurement input values, 154
B Configuring network connection settings, 269
– Activating cobas e-support, 275
Barcode scanner, 38
Roche Diagnostics
Index cobas b 123 POC system
– Adding and removing parameters from data Creating user-defined parameter groups, 158
transmission, 277
– Automatic network connection using DHCP server,
270
D
– Configuring ASTM protocol settings, 272
Database
– Configuring POCT1-A protocol settings, 274
– Calibration database, 229
– Enabling remote operator management, 276
Databases, 258
– Manual network connection using an IP address, 271
– Exporting data to a storage device, 258
– Manual network connection using DHCP and DNS
– Measuring database, 175
servers, 271
– Printing reports, 259
– Selecting protocols for performing queries, 276
– QC database, 192
Configuring operator settings, 278
– Searching for entries, 258
– Creating operators, 279
Defects, 320
– Deleting operators, 281
Defining and configuring QC materials, 203
– Editing operators, 280
– Defining new QC materials, 203
– Operator profiles, 278
– Deleting new QC materials, 206
Configuring QC rules and consequences, 207
– Editing the ranges for QC materials, 204
– Defining QC rules and consequences for parameters,
Depot repair, 330
207
Description of the screen areas, 252
– Enabling QC repeats for parameters, 208
– Consumable status window, 254
Configuring QC settings, 209
– Parameter selection field, 253
– Activating automatic QC measurement printouts, 210
– Status area, 252
– Configuring automatic AutoQC measurements, 209
Disinfecting the instrument, 301
Configuring system settings, 262
– Consumable area, 302
– Activating the internal printer, 267
– Screen, 301
– Changing the instrument name and hospital
– Surfaces, 301
information, 265
Disinfection procedures, 299
– Changing the language, 264
– Configuring data imports and exports, 267
– Configuring instrument volume settings, 265 E
– Configuring the instrument region and time zone, 263
– Configuring the instrument time, 263 Edition information, 4
– Configuring timeout settings, 266 Entering measurement input values, 170
Configuring the measurement results screen, 156 Environmental parameters, 84
Configuring the parameter selection field, 157 – Temperature / humidity / stability, 84
– Creating user-defined parameter groups, 158 Equations, 98
Configuring the QC scheduler, 199 Evaluating QC measurement results, 211
– Copying times in the QC scheduler, 200 – Multirules, 211
– Creating new times in the QC scheduler, 199 Exporting configuration settings, 285
– Deleting times in the QC scheduler, 202 External wetting, 326
– Editing times in the QC scheduler, 201
– Loading manufacturer QC schemes, 199
Consumable change, 297
F
– Additional information, 307
Fluid Pack, 46
– AutoQC Pack, 305
– Checking Fluid Pack valve positions, 327
– Fluid Pack, 304
– Consumable change, 304
– Sensor Cartridge, 303
– Cuvette, 49
Consumable information, 41
– Memory chip, 47
– AutoQC Pack, 49
– Operation fluids, 47
– Fluid Pack, 46
– Sample input module, 48
– Sensor Cartridge, 41
– Sample sensor contacts, 47
Consumable status window, 254
– Specifications, 85
Conversion table for units, 97
– Tubing, 47
Copyright information, 339
– Types, 46
– Software licenses, 341
Front door, 32
Correlation to other methods, 74
Roche Diagnostics
G M
Glossary, 343 Mandatory inputs, 170

Manual QC measurements, 185
Measurement, 137
H – Acid base map, 176
– Capillary measurements, 165
Holding points, 87
– Configuring measurement input values, 154
– Configuring the measurement results screen, 156
I – Configuring the parameter selection field, 157
– Entering measurement input values, 170
Imaging scanner, 39 – Interferences, 145
– Specifications, 92 – Limitations of clinical analysis, 152
Importing configuration settings, 285 – Mandatory inputs, 170
Information alarms, 322 – Measurement modes, 169
Installation, 129 – Measurement results and reports, 173
– Instrument location, 129 – Measuring database, 175
– Procedure, 131 – Patient trend diagrams, 177
Installing AutoCVC Packs, 236 – Plausibility check for neonatal bilirubin measurements,
Instrument 152
– Installation, 129 – Preanalytics, 139
– Put out of operation, 134 – Syringe measurements, 161
– For less than 24 hours, 134 Measurement modes, 169
– For more than 24 hours, 134 – Micro mode, 169
– Specifications, 84 – Minimum sample volumes, 169
Instrument tab, 256 Measurement parameters, 55
Intended use, 7 Measurement results and reports, 173
Intended user, 7 – Measurement reports, 174
Interfaces, 35, 37 – Results tab, 173
– Barcode scanner assignments, 36 Measuring chamber module, 32
– Network interface assignments, 36, 37 Measuring database, 175
– RS 232 interface assignment, 35 Monitoring reference and critical ranges on
– USB interface assignments, 36, 37 measurement reports, 121
Interferences, 145 Multirules, 211
– Substances with effect on BG, pH, ISE, Glu, Lac and
Hct, 148
– Substances with effect on tHb, SO2, bilirubin and Hb
N
derivatives, 149
Name plate, 35
– Substances without effect on BG, pH, ISE, Glu, Lac and
Network interface assignments, 36, 37
Hct, 145
Notation of measurement, input and calculation values,
– Substances without effect on tHb, SO2, Hb derivatives
248
and bilirubin, 147
Internal wetting, 326
O
L Operator profiles, 278
Overview tab, 251
Language update, 284
– Description of the screen areas, 252
Levey-Jennings graphs, 193
Oximeter calibration, 226
Limitations of clinical analysis, 152
Oximeter module
– General information, 152
– Functional principle, 114
Linearity
– Micro sample mode, 73
– Normal sample mode, 72 P
Log files, 329
Logging on and off, 260 Parameter selection field, 253
Patient trend diagrams, 177
Roche Diagnostics
Perfomance data Q
– Measurement parameters, 55
Performance data, 55 QC database, 192
– Comparison of micro samples to normal samples, 78 QC results and reports, 191
– Correlation to other methods, 74 – QC values tab, 191
– Linearity QC scheduler, 199
– Micro sample mode, 73 QC troubleshooting, 218
– Normal sample mode, 72 QC troubleshooting for parameters, 324
– Precision Quality control, 179
– Micro sample mode, 66 – AutoQC measurements, 184
– Normal sample mode, 55 – Configuring QC rules and consequences, 207
Plausibility check for neonatal bilirubin measurements, – Configuring QC settings, 209
152 – Configuring the QC scheduler, 199
PO2 calibration, 225 – Defining and configuring QC materials, 203
Power cable, 34 – Evaluating QC measurement results, 211
Power supply, 34 – General QC concept, 181
Preanalytics, 139 – Important information for evaluating QC results, 183
– Dialysis Solution, 144 – Levey-Jennings graphs, 193
– Sample collection, 139 – Manual QC measurements, 185
– Sample collection containers, 141 – Multirules, 211
– Sample handling, 143 – QC database, 192
Precision – QC materials
– Micro sample mode, 66 – Specifications, 85
– Normal sample mode, 55 – QC results and reports, 191
Printer, 32 – QC troubleshooting, 218
– Change printer paper, 306 – Removing QC consequences, 215
– Specifications, 88 – Troubleshooting AutoQC module blockages, 219
Product data, 86 – User-activated AutoQC measurements, 184
– Acoustic noise level, 86
– Classifications, 86
– Dimensions, 86
R
– Electrical data, 86
Recalibration, 226
– Weight, 86
Reference and critical ranges
Product names, 7
– Assigning a correlation factor to a parameter, 122
Proficiency test, 194
– Assigning reference and critical ranges, 118
– Proficiency test measurements, 195
– Critical ranges, 117
Publication information, 2
– Monitoring reference and critical ranges on
– Approvals, 3
measurement reports, 121
– Contact addresses, 4
– Reference/normal ranges, 115
– Copyright, 3
Reference and critical values, 115
– Edition notice, 2
Removing QC consequences, 215
– Feedback, 3
Roche MICROSAMPLER PROTECT, 142
– License information, 3
RS 232 interface assignment, 35
– Open source and commercial software, 3
– Revision history, 2
– Screenshots, 2 S
– Trademarks, 3
– Training, 2 Safety information, 15
– Warranty, 3 – Safety classifications, 17
Put out of operation, 134 – Safety labels on the instrument and consumables, 26
– For less than 24 hours, 134 – Safety precautions, 18
– For more than 24 hours, 134 – Biohazardous materials, 20
– Procedure, 135 – Electrical safety, 20
– Incorrect results, 23
– Installation and deinstallation, 19
– Instrument damage, 25
Roche Diagnostics
– Mechanical safety, 21 – Logging on and off, 260

– Operating conditions, 19 – Software update, 284
– Operator qualification, 18 Software licenses, 341
– Reagents and working solutions, 22 Software tab
– Safe and proper use of the system, 18 – Instrument tab, 256
– Software and data security, 24 – Utilities tab, 257
Sample collection, 139 Software tabs, 247
– Anticoagulants, 140 – Overview tab, 251
– Bilirubin measurements, 141 – Workplace tab, 255
– Dialysis solution measurements, 141 Software update, 284
– Glucose and lactate measurements, 140 Specifications, 51
– tHb, SO2 and Hct measurements, 140 – Barcode scanner, 90
– Whole blood measurements, 139 – Calibrations, 83
Sample collection containers, 141 – Environmental parameters, 84
– Accessories, 142 – Fluid Pack, 85
– Clot Catcher, 142 – Imaging scanner, 92
– Clot Catcher PRO, 143 – Instrument, 84
– Capillary tubes, 142 – Performance data, 55
– Roche MICROSAMPLER PROTECT, 142 – Printer, 88
– Syringes, 142 – Product data, 86
Sample handling, 143 – QC material, 85
– Whole blood, 143 – Sample measurement time, 80
– Glass sample container, 143 – Sample throughput, 79
– Plastic sample container, 143 – Sample types, 82
Sample measurement time, 80 – Sample volumes, 81
Sample throughput, 79 – Sensor Cartridge, 84
Sample types, 82 – User interface module, 89
Sample volumes, 81 Standard values and ranges, 97
Security levels, 282 Standby calibration, 226
– Changing security level, 283 Standby shifting, 226
Sensor Cartridge, 41 Status area, 252
– BG sensors, 43 Status messages on the measurement report, 323
– Consumable change, 303 Symbols, 7
– External wetting, 326 – Symbols used in the instrument, 8
– Glu/Lac sensors, 45 – Symbols used in the publication, 7
– Internal wetting, 326 – Symbols used on consumables, 8
– ISE sensors, 44 Syringes, 142
– Memory chip, 41 System calibration, 225
– Sensor phases, 42 System components, 31
– IN-USE time, 42 – Barcode scanner, 38
– RUN-IN phase, 42 – Front door, 32
– Stable phase, 42 – Imaging scanner, 39
– START-UP phase, 42 – Interfaces, 35, 37
– Specifications, 84 – Measuring chamber module, 32
– Types, 41 – Oximeter module
– Wetting routines, 326 – Functional principle, 114
Software functions, 245 – Power cable, 34
– Audit trail, 286 – Power supply, 34
– Changing security levels, 282 – Printer, 32
– Configuring network connection settings, 269 – Rear panel, 33
– Configuring operator settings, 278 – Screen, 40
– Configuring system settings, 262 – User interface module, 40
– Connecting USB storage devices, 261 – Visual identification, 31
– Exporting and importing configuration settings, 285 System information, 29
– General information, 247 – Accessory information, 30
– Language update, 284 – Instrument versions, 29
Roche Diagnostics
– Sample types, 30
System stops, 316
Troubleshooting, 311
– Alarm area and buttons, 314
– Barcode scanner, 328
– Calibration troubleshooting for parameters, 324
– Checking Fluid Pack valve positions, 327
– Creating log files, 329
– Creating troubleshooting reports, 329
– Defects, 320
– General information, 313
– Information alarms, 322
– QC troubleshooting for parameters, 324
– Quality control, 218
– Status messages on the measurement report, 323
– System stops, 316
– Troubleshooting AutoQC module blockages, 219
– Warnings, 321
Troubleshooting AutoQC module blockages, 219
Troubleshooting reports, 329
USB interface assignments, 36, 37

Use environment, 7
User interface module, 40
– Specifications, 89
User-activated AutoQC measurements, 184
User-activated calibrations, 228
– Calibration for "Ready", 228
Utilities tab, 257
Warnings, 321
Wash cycle, 227
Wetting routines, 326
What is new in publication version 11.0, 12
Workplace tab, 255
Roche Diagnostics

Cobas B 123 POC System: Instructions For Use, Version 13.0 Software Version 4.17

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Cobas B 123 POC System: Instructions For Use, Version 13.0 Software Version 4.17

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cobas b 123 POC system

Instructions for Use, Version 13.0

Revision history Manual Version Software Version Revision date Changes

Copyright © 2009-2020, F. Hoffmann-La Roche Ltd. All rights reserved.

For in vitro diagnostic use.

Complies with the provisions of the applicable EU directives.

Issued by TÜV SÜD for Canada and the US.

Laboratory Equipment is the product identifier as shown on the

Manufacturer Roche Diagnostics GmbH

Version 13.0, August 2020

Publication information 2 Operation

9 Calibration verification control Appendix

Symbols and abbreviations

Product name Descriptor

Symbols used in the publication Symbol Explanation

Symbols used on the instrument Symbol Description

Global Trade Item Number

Table 4 Symbols used on the instrument

Symbols used on consumables Symbol Description

Global Trade Item Number

Table 5 Symbols used on consumables

Do not use if package is damaged

Fragile handle with care

Sterilized using irradiation

Sterilized using ethylene oxide

Sufficient for <n> tests

Operator’s manual/operating instructions

Caution, consult accompanying documents

Handle with care

Software symbol for the Fluid Pack

Table 5 Symbols used on consumables

Software symbol for the AutoQC Pack

Software symbol for the Sensor Cartridge

Table 5 Symbols used on consumables

Abbreviations Abbreviation Definition

What is new in this version

o Updates for new hardware version

1 Safety information ........................................................................................................................... 15

In this chapter Chapter 1

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

Safe and proper use of the system

Missing personal protective equipment

Installation and deinstallation

Disposal A biohazardous system may lead to infection.

NOTICE Unsuitable operating conditions

Sharp objects Contact with probes or needles may result in infection.

Opening and closing the instrument’s door

Incorrect handling of consumables

Handling QC material and AutoCVC packs

NOTICE Inserting damaged consumables

Reagents and working solutions

Skin inflammation or injury

Fire and burns Alcohol is a flammable substance.

Software and data security

Unauthorized system access and data loss

NOTICE Circuit breakers and fuses

Safety labels on the instrument and consumables

Safety labels on the instrument Biohazard

Safety labels on consumables Biohazard

In this chapter Chapter 2

Figure 2-1 cobas b 123 POC system

Instrument variants Measured parameters

(1) total bilirubin