Roche cobas b 123 <4> User manual

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User manual

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cobas b 123 POC system
Instructions for Use
COBAS, COBAS B and LIFE NEEDS ANSWERS
are trademarks of Roche.
©2018 Roche
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
www.roche.com
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 3
cobas b 123 POC system
Publication information
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.
War ranty 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.
Always leave software updates to a Roche Service representative, or perform such
updates with their assistance.
Copyright © 2009-2018, F. Hoffmann-La Roche Ltd. All rights reserved.
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
Table 1 Revision history
cobas b 123 POC system
Roche Diagnostics February 2018
4 Instructions for Use · Version 11.0
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
Software
cobas b 123 POC system may include components or modules of commercial or
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.
Issued by TÜV SÜD for Canada and the US.
Laboratory Equipment is the product identifier as shown on the
name plate.
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 5
cobas b 123 POC system
Contact addresses
Manufacturer
Edition
Version 11.0, February 2018
First edition: November 2009
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
www.roche.com
cobas b 123 POC system
Roche Diagnostics February 2018
6 Instructions for Use · Version 11.0
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 7
cobas b 123 POC system
Table of contents
Publication information 3
Contact addresses 5
Edition 5
Table of contents 7
Intended use 9
Intended user 9
Use environment 9
Symbols and abbreviations 9
What is new in publication version 11.0 14
Introduction and specifications
1 Safety information
Safety classifications 19
Safety precautions 20
Safety labels on the instrument and
consumables 27
2 General description
System information 31
System components 33
Consumable information 42
3 Specifications
Performance data 57
Sample throughput 81
Sample measurement time 82
Sample volumes 83
Sample types 84
Calibrations 85
Environmental parameters 86
Product data 88
Printer 90
User interface module 91
Barcode scanner 92
Imaging scanner (optional) 93
4 Theoretical foundations
Assigning unit formats to parameters 97
Selecting between pH and H
+
unit formats 98
Parameters and calculations 99
Calibration principle 115
Oximeter module (optional) 116
Reference and critical values 117
Assigning reference and critical ranges 120
Monitoring reference and critical ranges on
measurement reports 123
Assigning a correlation factor to a parameter 124
Operation
5 Installation and put out of operation
Installation 131
Installing the instrument 132
Put out of operation 134
6 Measurement
Preanalytics 139
Interferences 144
Limitations of clinical analysis 151
Configuring measurement input values 153
Configuring the measurement results screen 155
Configuring the parameter selection field 156
Performing a measurement 159
Measurement modes 167
Entering measurement input values 168
Measurement results and reports 171
Measuring database 173
Acid base maps 174
Patient trend diagrams 175
7 Quality control
General QC concept 179
Important information for evaluating QC
results 181
Performing QC measurements 182
QC results and reports 189
QC database 190
Levey-Jennings graphs 191
Performing a proficiency test measurement 192
Configuring the QC scheduler 197
Defining and configuring QC materials 201
Configuring QC rules and consequences 205
Configuring QC settings 207
Evaluating QC measurement results 209
Multirules 210
Removing QC consequences 213
QC troubleshooting 216
Troubleshooting AutoQC module blockages 217
8 Calibration
General information 221
Automatic calibrations 223
User-activated calibrations 226
Calibration database 227
Configuring calibration settings 228
Roche Diagnostics February 2018
8 Instructions for Use · Version 11.0
cobas b 123 POC system
9 Calibration verification control
General information 233
Installing AutoCVC Packs 234
Performing an AutoCVC measurement 236
Managing CVC results in the QC database 238
Configuring analytical measurement ranges 239
10 Software functions
General software information 245
Overview tab 249
Description of the screen areas 250
Workplace tab 253
Instrument tab 254
Utilities tab 255
Instrument databases 256
Logging on and off 258
Connecting USB storage devices 259
Configuring system settings 260
Configuring network connection settings 267
Configuring operator settings 276
Changing security levels 280
Performing software and language updates 282
Exporting and importing configuration
settings 283
Audit trail 284
Available printout reports 286
Consumable change
11 Consumable change
Disinfection procedures 297
Disinfecting the instrument 298
Changing consumables 300
Additional information for consumable
changes 303
Troubleshooting
12 Troubleshooting
General information 309
Alarm area and buttons 310
System stops 312
Defects 316
Warnings 317
Information alarms 318
Status messages on the measurement report 319
Calibration and QC troubleshooting for
parameters 320
Performing Sensor Cartridge wetting
routines 322
Checking the Fluid Pack valve positions 323
Barcode scanner troubleshooting 324
Creating troubleshooting reports and log files 325
Depot repair 326
Appendix
13 Available accessories and consumables
Available accessories and consumables 331
14 Copyright information
Software license information 337
15 Glossary
Index
Index 345
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 9
cobas b 123 POC system
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 (O
2
Hb,
HHb, COHb, MetHb), oxygen saturation (SO
2
) 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 instrument 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.
Symbols used in the publication
Product name Descriptor
cobas b 123 POC system system
cobas b 123 POC systems 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
Symbol Explanation
o List item
r Start of a task
Table 3 Symbols used in the publication
cobas b 123 POC system
Roche Diagnostics February 2018
10 Instructions for Use · Version 11.0
Symbols used on the instrument
Symbols used on consumables
s End of a task
u Related topics containing further information
q Tip. Extra information on correct use or useful hints.
Symbol Explanation
Table 3 Symbols used in the publication
Symbol Description
Catalog number
Serial number
Global Trade Item Number
Manufacturer
Date of manufacture
Direct current
Caution
Table 4 Symbols used on the instrument
Symbol Description
Catalog number
Batch code
Global Trade Item Number
Use by date
Table 5 Symbols used on consumables
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 11
cobas b 123 POC system
Temperature limitation
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
Operators manual/operating instructions
Caution, consult accompanying documents
Handle with care
Symbol Description
Table 5 Symbols used on consumables
cobas b 123 POC system
Roche Diagnostics February 2018
12 Instructions for Use · Version 11.0
Abbreviations
Software symbol for the Fluid Pack
Software symbol for the AutoQC Pack
Software symbol for the Sensor Cartridge
Symbol Description
Table 5 Symbols used on consumables
Abbreviation Definition
1P 1-point calibration
2P 2-point calibration
AMR Analytical measurement range
A
rate
Assisted breathing rate
ASTM American Society for Testing and Material
AutoQC Automatic Quality Control
BG Blood gas
Bili Bilirubin
BSA Bovine serum albumin
Ca
2+
Ionized calcium
CCD Charge coupled device
CE Conformité Européenne
CF Compact flash
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
HHb Deoxyhemoglobin
Table 6 Abbreviations
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 13
cobas b 123 POC system
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
O
2
Hb Oxyhemoglobin
PCO
2
Partial pressure of carbon dioxide
PEEP Positive end-expiratory pressure
PIP Peak inspiratory pressure
PO
2
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
SIM Sample input module
SO
2
Oxygen saturation
S
rate
Spontaneous breathing rate
STDBY Standby
Te Expiratory time
tHb Total hemoglobin
Ti Inspiratory time
UIM User interface module
USB Universal Serial Bus
VT Tidal volume
Abbreviation Definition
Table 6 Abbreviations
cobas b 123 POC system
Roche Diagnostics February 2018
14 Instructions for Use · Version 11.0
What is new in publication version 11.0
“What is new in publication
version section
This section describes new content that is found in this version of the Instructions for
Use.
Editorial changes Considerable editorial changes have been made to the Instructions for Use to make it
easier for you to find content and perform your tasks on the
cobas b 123 POC system.
New plausibility check to perform
neonatal bilirubin measurements
A new plausibility check feature has been added to the software to identify erroneous
bilirubin results.
u Plausibility check for neonatal bilirubin measurements (p. 151)
New barcode scanner The Datalogic Touch 90 barcode scanner replaces the Unitech MS 180 barcode
scanner. Datalogic Touch 90 barcode scanners include a wider scanner area to help
scan longer barcodes on consumable material sheets.
u Barcode scanner (p. 39)
u Barcode scanner troubleshooting (p. 324)
New consumable information Plastic capillary tubes (material 05174791001) and sterile capillary holders (material
05174830001) have been discontinued.
u Available accessories and consumables (p. 329)
Revised reference ranges for
glucose and lactate
u Reference and critical values (p. 117)
Status message information on
measurement reports
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.
A list of these messages is now found in this version of the Instructions for Use.
u Status messages on the measurement report (p. 319)
New approvals section Compliance of all applicable directives and guidelines for the
cobas b 123 POC system can now be found in the approvals section at the front of the
Instructions for Use.
u Approvals (p. 4)
February 2018
Introduction and specifications
1 Safety information ........................................................................................................................... 17
2 General description.......................................................................................................................... 29
3 Specifications.................................................................................................................................... 53
4 Theoretical foundations ................................................................................................................... 95
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 17
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.............................................................................................................19
Safety precautions.................................................................................................................20
Operator qualification...................................................................................................20
Installation and deinstallation......................................................................................20
Operating conditions.....................................................................................................21
Safe and proper use of the system................................................................................21
Electrical safety...............................................................................................................21
Biohazardous materials .................................................................................................22
Mechanical safety...........................................................................................................23
Consumables...................................................................................................................23
Reagents and working solutions...................................................................................24
Incorrect results..............................................................................................................24
Software and data security............................................................................................25
Instrument damage........................................................................................................26
Safety labels on the instrument and consumables ...........................................................27
Roche Diagnostics February 2018
18 Instructions for Use · Version 11.0
1 Safety information cobas b 123 POC system
Table of contents
Roche Diagnostics February 2018
Instructions for Use · Version 11.0 19
cobas b 123 POC system 1 Safety information
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
WARNING
r ... indicates a hazardous situation that, if not avoided, could result in death or serious
injury.
CAUTION
CAUTION
r ... indicates a hazardous situation that, if not avoided, could result in minor or moderate
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 February 2018
20 Instructions for Use · Version 11.0
1 Safety information cobas b 123 POC system
Safety precautions
Safety precautions
To avoid serious or fatal injury, read and comply with the following safety
precautions.
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.
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 18 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. 89)
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.
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Roche cobas b 123 <4> User manual

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