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cobas p 612
pre-analytical system (63x)
User Guide
Publication version 3.2
Software version 2.1.0
2
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Publication information
Revision history
Publication
version
Software version Revision date Change description
3.0 2.1.0 or higher April 2019 First version of the separated safety guide and user guide from the
operators manual.
3.1 2.1.0 or higher December 2019 Updated Maintenance menu screen shots, information about
analog and digital QSI camera, barcode clarifications.
Modification of the decapping module requires additional cleaning
procedures.
3.2 2.1.0 or higher March 2021 Safety Guide
Update of: Data security, labeling on protective covers
New information about: Name plate for systems with serial
number starting 632xxxxx
User Guide
Update of: cleaning agents for protective covers, cleaning
procedures for modified decapping module, tube specifications,
switching on the system
New information about: 24 position rack for 16 mm tubes, new
barcode label printer, samples to be processed, loading collapsible
rack trays
y Revision history
Edition notice This publication is intended for operators of cobas p 612
pre-analytical system (63x).
Every effort has been made to ensure that all the
information contained in this manual is correct at the
time of printing. However, Roche Diagnostics GmbH
reserves the right to make any changes necessary
without notice as part of ongoing product development.
Where to find information The User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• Configuration information
• Background information such as measurement
principle
The Safety Guide contains important safety information.
It includes grouped safety messages and topics such as
Safety information for laser exposure. You must read the
safety guide before operating the system.
3
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
The User Guide consists of the chapters: system
description, operation, maintenance, troubleshooting,
glossary, and appendix. Embedded safety information is
incorporated in the User Guide. The chapters are
organized according to the normal operation workflow.
General attention
To avoid serious or fatal injury, ensure familiarization
with the system and safety information before use.
rPay attention to all safety precautions.
rAlways follow the instructions in this publication.
rDo not use the system in a way that is not described
in this publication.
rStore all publications in a safe and retrievable place.
Privacy notice When you use User Assistance online, viewing events
(topics viewed and searches performed) and IP
addresses are logged. The data collected is for Roche
internal use only and is never forwarded to third parties.
It is anonymized, and after one year it is automatically
deleted. Viewing events are analyzed to improve User
Assistance content and search functionality. IP addresses
are used to classify regional behavior
Training Do not carry out operation tasks, maintenance actions, or
troubleshooting tasks without training from Roche
Diagnostics. 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.
4
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
wAn example of the type of screenshots used in this document
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 © 2021, Roche Diagnostics GmbH. All rights reserved.
Open source and commercial software Portions of the pre-analytical system include one or more
open source or commercial software programs.
Copyright, notices, and licensing information regarding
the software programs are available in the system.
Trademarks The following trademarks are acknowledged: cobas and
cobas p are the trademark of Roche.
All other trademarks are the property of their respective
owners.
5
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Feedback Every effort has been made to ensure that this
publication fulfils the intended purpose. All feedback on
any aspect of this publication is welcome and is
considered during updates. Contact the Roche Service
representative for any feedback.
Approvals The cobas p 612 pre-analytical system meets the
protection requirements specified in IVD Directive 98/79/
EC.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU
directives.
Issued by Intertek (Electrical Testing Laboratory) for
Canada and the US.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Germany
6
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
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7Table of contents
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Table of contents
Publication information 2
Intended use 9
About Good Laboratory Practice 9
Lists of symbols & abbreviations 10
What is new in publication version 3.2 13
System Description
1 Overview of the system
About the system 19
2 Hardware description
About control unit 25
About QNX operating system 26
About QSI computer 27
About interface panel 28
About input sorter module 29
About primary tube transport 30
About tube type identification camera 31
About Laser LLD 36
About spin status detection 39
About barcode reader 41
About decapping module 42
About tube separator 43
About Series A4+ barcode label printer 44
About SQUIX barcode label printer 45
About print transport 46
About secondary tube transport 47
About aliquoting module 48
About the pipetting process 49
About recapping module 50
About output sorter module 51
About CCM integration 52
About status light 55
About compressed air connection 56
About accessories 57
About waste containers 58
Schematic representation of the hardware 59
3 Sample flow and processing
The system workflow 63
Schematic representation of sample
processing 64
About communication mode 65
About record transmission 66
About sorting list transmission 67
Barcode types 68
About sorting and error racks 69
About open sample tubes 70
About archiving sample tubes 71
About dynamic interface 72
About standard interface 73
4 Overview of the user interface
Software description 79
Serum TeachIn QSI 116
5 Overview of the User Assistance
About the User Assistance 129
Overview of User Assistance functions 131
Accessing the User Assistance online 133
Accessing the User Assistance offline 134
Operation
6 Before routine operation
About the protective covers 139
Adjusting the position of monitor and
keyboard 140
Workflow before the operation 141
Prerequisites for scanning a barcode 142
Emptying waste containers 155
Reloading secondary tubes 157
About pipette tip racks 159
Inserting pipette tip racks 160
Emptying the condensate container 165
Inserting sealing foil for the recapping
module 166
Setting up the barcode label printers 170
Loading the input sorter module 195
Loading the output sorter module with
sorting racks 199
Loading the CCM with rack trays 200
Using the guide angle to load racks 201
Switching on the system 203
Login info 204
7 During routine operation
About workflow during operation 209
Selecting and starting the work cycle 210
Feeding primary samples 212
Loading input sorter with samples, racks,
and trays during operation 213
Emptying and replacing full sorting racks 215
Loading a 24-position centrifuge rack 217
Loading collapsible rack trays 218
Processing STAT samples 220
Processing recursive samples 221
Accessing sample data 223
Tracking sample status 224
Synchronizing the SQUIX paper feed 225
Starting the SQUIX peel-off mode 226
Activating standby mode 227
Toggling between QSI and QNX 228
Error messages during the operation 229
8 After routine operation
Logging off from the system 233
Reorganizing for next use 234
8Table of contents
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Emptying output sorter 235
Shutting down the system 236
9 Non-routine operation
Emptying waste containers 239
Activating standby mode 241
Using main switch to power off 242
Adjusting the label edge sensor 243
Setting Date/Time 244
Rack feeds (CCM Hitachi®) 245
Rack feeds (CCM Sysmex®) 248
Archiving samples 251
Reorganizing database 252
Connecting the compressed air hose 253
Disconnecting the compressed air hose 254
Maintenance
10 Maintenance overview
About maintenance 259
Maintenance schedule 261
11 Weekly maintenance
Cleaning the pipetting unit 265
Cleaning the barcode label printers 269
Cleaning the print transport turning unit 278
Cleaning the decapping module 279
12 Monthly maintenance
About general monthly maintenance 291
Cleaning the barcode reader 292
Cleaning the primary tube transport sensors 294
Cleaning the Laser LLD 295
13 As needed maintenance
As needed maintenance 299
Replacing the main fuse 308
About the TTI module lighting 310
Emptying the condensate container 311
Troubleshooting
14 General troubleshooting
Resolving general problems 317
Troubleshooting the barcode label printers
and readers 320
Barcode reading problems 323
Sorting area 324
Recapping, decapping, and camera modules 330
CCM connection 333
Laser-LLD, separator unit, and the aliquoting
module 336
15 System and error messages
General problems 345
List of error messages 346
List of informative messages 383
Appendix
16 System specifications
List of items included in delivery 397
List of electrical specifications 398
List of dimensions and weight specifications 399
List of compressed air supply specifications 400
List of environmental conditions
specifications 401
List of barcode reader specifications 402
Barcode reader 404
List of SQUIX 4.3 barcode label printer
specifications 405
List of pipetting unit specifications 406
QSI system (optional) 407
List of recapping module specifications 409
List of system interface specifications 410
List of system operating time 411
List of cleaning solutions and equipments 412
17 Supported material
List of consumable materials 415
List of accessories 416
List of sample tube specifications 417
List of cap specifications 419
List of rack specifications 420
Glossary
Index
9
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Intended use
cobas p 612 pre-analytical system (63x) is a computer-
controlled fully automatic system for sorting of open and
closed barcoded, centrifuged, and non-centrifuged
sample tubes. It is used with analyzers that perform tests
in the area of clinical chemistry, immuno chemistry,
coagulation, hematology, urinanalysis, and nucleic acid
testing.
It includes modules for registration and decapping of
sample tubes, liquid level detection, and sample quality
assessment (optional), recapping of sample tubes
(optional), barcode printing, as well as aliquoting of
primary and secondary tubes.
In case of standalone use of the pre-analytical system,
the transfer of tubes processed on the pre-analytical
system to any other workstation within the laboratory is a
subject of validation performed by laboratory itself.
About Good Laboratory Practice
Good Laboratory Practice Some area of the instrument may have sharps, rough
edges, and/or moving parts.
rGood Laboratory Practice can reduce the risk of
injury. Be aware of your laboratory environment, be
well-prepared, and follow the Instructions for Use.
rWear personal protective equipment to minimize the
risk of injury and contamination from bodily contact
with such parts, especially in less accessible areas, or
while cleaning the instrument.
rYour personal protective equipment should be
appropriate to the degree and type of potential
hazard such as suitable lab gloves, eye protection, lab
coat, and footwear.
10 Lists of symbols & abbreviations
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Lists of symbols & abbreviations
This list is applicable to the entire user documentation.
Symbols used in the publication Symbol Explanation
oList item
uRelated topics containing further information
uTopic
wFigure
yTable
qTip
IAdditional information
rTask
dMaterial
fProcedure result
jPrerequisites
lChecklist
cFrequency
Caution
y Symbols used in the publication
Symbols used on product Symbol Explanation
In vitro diagnostic device
Catalog number
Serial number
Intertek Electrical Testing Laboratory
Manufacturer
y Symbols used on product
11Lists of symbols & abbreviations
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Symbol Explanation
Date of manufacture
Caution
Alternating current
Fuse
Disposal of control unit components
y Symbols used on product
Abbreviations used in the publication Abbreviation Explanation
A Ampere
AC Alternating Current
ADP Air-displacement pipettor (pipetting module)
Ah Ampere hour
ASTM American Society for Testing and Materials
BGV Berufsgenossenschaftliche Vorschriften
CCM cobas® connection modules
CE Communauté Européenne
CPU Central processing unit
CU Control unit
dB Decibel
DC Direct current
DIN Deutsche Industrie Norm (German industry
standard)
DVD Digital versatile disc
ebox-one Control unit of the CCM
EC European community
EDP Event distribution protocol
EMC Electromagnetic compatibility
EN European standard
EPROM Erasable programmable read only memory
ETL Electrical Testing Laboratories
FCC Food chemicals codex
GB Gigabyte
GS1 Global Standard 1
GTIN Global Trade Item Number (trade item
identifier to look up product information in a
database)
GUI Graphical user interface
y Abbreviations used in the publication
12 Lists of symbols & abbreviations
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Abbreviation Explanation
Hz Hertz
IEC International Electrotechnical Commission
IT Information technology
IQ/OQ Installation Qualification/Operation
Qualification
IVD In vitro diagnostic
LASER Light Amplification by Stimulated Emission of
Radiation
LCD Liquid crystal display
LED Light emitting diode
LIS Laboratory Information System
LLD Liquid level detection
MB Megabyte
Mbps Megabits per second
MTH Multi-tube holder
NN Normal null (mean sea level)
NW Nominal width
PCS Print Contrast Signal
PE Protective earth
PIO Parallel I-O interface
PRT Print transport
PTT Primary tube transport
QC Quality control
QSI Quality system one
RAM Random access memory
RCM Rack conveyor module
RFM Rack feed module
RJ45 Registered jack 45
ROI Region of Interest
RS232/422 Recommended standard 232/422
RSR Roche Service representative
SI Sample Image
STAT Short turn around time
STT Secondary tube transport
TCP/IP Transmission control protocol/ internet
protocol
TTI Tube type identification
UTC Universal Time Coordinated
UPS Uninterruptible power supply
V Volt
VA Volt-Ampere
WEEE Waste of Electrical and Electronic Equipment
cobas p 612 cobas p 612 pre-analytical system (63x)
y Abbreviations used in the publication
13What is new in publication version 3.2
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
What is new in publication version 3.2
This section provides an overview of all major changes in
this publication and the software.
New topics Following sections include new additions and updates
related to cobas p 612 (63x) pre-analytical system in the
User Guide.
uSwitching on the system (203)
uLoading collapsible rack trays (218)
uCleaning steps for modified decapping module (279)
uLoading a 24-position centrifuge rack (217)
uCleaning the housing and component surfaces (299)
uPrimary tube dimension range (418)
uAbout SQUIX barcode label printer (45)
uCleaning the rotary gripper (284)
uList of rack specifications (420)
uSamples to be processed (418)
14 What is new in publication version 3.2
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
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Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
System Description
1 Overview of the system...............................................................................17
2 Hardware description ..................................................................................23
3 Sample flow and processing.....................................................................61
4 Overview of the user interface .................................................................77
5 Overview of the User Assistance...........................................................127
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18 Table of contents
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
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1 Overview of the system
19Overview of the system
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
About the system
System definition cobas p 612 pre-analytical system (63x) is a computer-
controlled fully automatic system for sorting of open and
closed barcoded, centrifuged, and non-centrifuged
sample tubes. It is used with analyzers that perform tests
in the area of clinical chemistry, immuno chemistry,
coagulation, hematology, urinanalysis, and nucleic acid
testing.
• The system operates with an online connection to the
LIS.
Hardware overview
A
B
C
D
E F G
H
I
AStatus light FBarcode label printer and applicator
BControl unit GAliquoting module
CTube type identification module HOutput sorter
DPower switch IRecapping module
EInput sorter
wcobas p 612 pre-analytical system (63x)
System components
Component Function
Input sorter module Sample tubes are loaded onto this part of the instrument and
subsequently sorted.
y Main components of the cobas p 612 pre-analytical system (63x)
1 Overview of the system
20 About the system
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2
Component Function
Aliquoting module A module that uses an air-displacement pipetter (ADP) with
pipette tips to aspirate and dispense sample material from
primary containers into secondary containers.
Output sorter module Sample tubes are sorted to designated targets and
subsequently unloaded from this module.
Control unit External PC that communicates with the instrument and
manages data.
Primary and secondary tube transport Units responsible for transporting primary and secondary
tubes.
Barcode readers Devices that read barcode labels on primary and secondary
tubes.
Barcode label printer and applicator Device that prints barcode labels and applies it on tubes.
Optical tube type identification Options: QSI full version, TTI camera
Decapping module Module where caps are removed from sample tubes.
Secondary tube separation and loading Unit separating a part of the sample from the primary samples.
Recapping module (optional) Module that closes sample containers with sealing foil.
CCM module (optional) Module that enables an unidirectional connection of the pre-
analytical system to analysis instruments.
Connectivity to centrifuge units or BLM Device that is used for the automatic separation and
reorientation of closed sample containers.
y Main components of the cobas p 612 pre-analytical system (63x)
Intended user cobas p 612 pre-analytical system (63x) is intended to
be used by trained laboratory technicians.
Training • A Roche Service representative is present during the
system installation to train the operator.
• This training prepares the operator to perform routine
operation and maintenance actions safely without
close supervision.
Using the User Guide • The document contains information useful for the
operator of the cobas p 612 pre-analytical system
(63x)
• It is not intended for the laboratory administrator or
Roche Service representatives.
• Failure to observe risk and safety notices present in
this user documentation can result in serious health
and safety implications and/or material damage.
• Read the User Guide with careful attention before
using the system for the first time.
• Pay particular attention to descriptions of hazards and
precautions.
• Keep the document accessible for all system
operators in the laboratory.
Customer configuration • The system software is pre-configured with all
required processing parameters for daily operations
before the installation at the customer's location.
1 Overview of the system
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