Roche cobas p 612 LCP1 User guide

Type
User guide
cobas p 612
pre-analytical system (63x)
User Guide
Publication version 3.1
Software version 2.1.0
2
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
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.
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
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.
The Safety Guide contains important safety information.
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 3.1
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.
r Pay attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the system in a way that is not described
in this publication.
r Store all publications in a safe and retrievable place.
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 3.1
wAn 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
© 2020, 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 3.1
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 3.1
7Table of contents
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
Table of contents
Publication information 2
Intended use 10
About Good Laboratory Practice 10
Lists of symbols & abbreviations 11
What is new in publication version 3.1 14
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 barcode label printer 44
About print transport 45
About secondary tube transport 46
About aliquoting module 47
About the pipetting process 48
About recapping module 49
About output sorter module 50
About CCM integration 51
About status light 54
About compressed air connection 55
About accessories 56
About waste containers 57
Schematic representation of the hardware 58
3 Sample flow and processing
The system workflow 61
Schematic representation of sample
processing 62
About communication mode 63
About record transmission 64
About sorting list transmission 65
Barcode types 66
About sorting and error racks 67
About open sample tubes 68
About archiving sample tubes 69
About dynamic interface 70
About standard interface 71
4 Overview of the user interface
Software description 77
Serum TeachIn QSI 112
5 Overview of the User Assistance
About the User Assistance 125
Using User Assistance 126
Operation
6 Before routine operation
About commissioning the system 133
About the protective covers 134
Adjusting the position of monitor and
keyboard 135
Workflow before the operation 136
Prerequisites for scanning a barcode 137
Emptying waste containers 150
Reloading secondary tubes 152
About pipette tip racks 154
Inserting pipette tip racks 155
Emptying the condensate container 160
Inserting sealing foil for the recapping
module 161
Setting up the barcode label printer 165
Loading the input sorter module 174
Loading the output sorter module with
sorting racks 178
Loading the CCM with rack trays 179
Using the guide angle to load racks 180
Switching on the system 182
Login info 183
7 During routine operation
About workflow during operation 187
Selecting and starting the work cycle 188
Feeding primary samples 190
Loading input sorter with samples, racks,
and trays during operation 191
Emptying and replacing full sorting racks 193
Loading the 24-position centrifuge rack 195
Processing STAT samples 196
Processing recursive samples 197
Accessing sample data 199
Tracking sample status 200
Activating standby mode 201
Toggling between QSI and QNX 202
Error messages during the operation 203
8 After routine operation
Logging off from the system 207
Reorganizing for next use 208
Emptying output sorter 209
Shutting down the system 210
9 Non-routine operation
Emptying waste containers 213
8 Table of contents
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
Activating standby mode 215
Using main switch to power off 216
Adjusting the label edge sensor 217
Setting Date/Time 218
Rack feeds (CCM Hitachi®) 219
Rack feeds (CCM Sysmex®) 222
Archiving samples 225
Reorganizing database 226
Connecting the compressed air hose 227
Disconnecting the compressed air hose 228
Maintenance
10 Maintenace overview
About maintenance 233
Maintenance schedule 235
11 Weekly maintenance
Cleaning the pipetting unit 239
Cleaning the barcode label printer 243
Cleaning the print transport turning unit 247
Cleaning the decapping module 248
12 Monthly maintenance
About general monthly maintenance 257
Cleaning the barcode reader 258
Cleaning the primary tube transport sensors 260
Cleaning the Laser LLD 261
13 As needed maintenance
As needed maintenance 265
Replacing the main fuse 274
About the TTI module lighting 276
Emptying the condensate container 277
Troubleshooting
14 General troubleshooting
Resolving general problems 283
Troubleshooting on the barcode label printer
and reader 286
Barcode reading problems 288
Sorting area 289
Recapping, decapping, and camera modules 295
CCM connection 298
Laser-LLD, separator unit, and the aliquoting
module 301
15 System and error messages
General problems 311
List of error messages 312
List of informative messages 349
Appendix
16 System specifications
List of items included in delivery 361
List of electrical specifications 362
List of dimensions and weight specifications 363
List of compressed air supply specifications 364
List of environmental conditions
specifications 365
List of barcode reader specifications 366
Barcode reader 368
List of barcode label printer specifications 369
List of pipetting unit specifications 370
QSI system (optional) 372
List of recapping module specifications 374
List of system interface specifications 375
List of system operating time 376
List of cleaning solutions and equipments 377
17 Supported material
List of consumable materials 381
List of accessories 382
List of sample tubes specifications 383
List of caps specifications 385
List of racks specifications 386
Glossary
Index
9
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
10
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
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.
r Good Laboratory Practice can reduce the risk of
injury. Be aware of your laboratory environment, be
well-prepared, and follow the Instructions for Use.
r Wear 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.
r Your 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.
11Lists of symbols & abbreviations
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
Lists of symbols & abbreviations
This list is applicable to the entire user documentation.
Symbols used in the publication
Symbol Explanation
o
List item
u
Related topics containing further information
u
Topic
w
Figure
y
Table
q
Tip
I
Additional information
r
Task
d
Material
f
Procedure result
j
Pre-requisites
l
Checklist
c
Frequency
Caution
y Symbols used in the publication
Symbols used on product
Symbol Explanation
In vitro diagnostic device
Catalogue number
Serial number
Manufacturer
Date of manufacture
y Symbols used on product
12 Lists of symbols & abbreviations
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
Symbol Explanation
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 module
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
FCC Food chemicals codex
GB Gigabyte
GUI Graphical user interface
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
y Abbreviations used in the publication
13Lists of symbols & abbreviations
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
Abbreviation Explanation
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
14 What is new in publication version 3.1
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
What is new in publication version 3.1
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.
u QSI quality system with camera and image
processing computer (32)
u Cleaning steps for modified decapping module (248)
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
System Description
1 Overview of the system...............................................................................17
2 Hardware description ..................................................................................23
3 Sample flow and processing.....................................................................59
4 Overview of the user interface .................................................................75
5 Overview of the User Assistance...........................................................123
17
Table of contents
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
Overview of the system
In this chapter
1
About the system ................................................................... 19
1 Overview of the system
18
Table of contents
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
1 Overview of the system
19Overview of the system
Roche Diagnostics
cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1
About the system
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
A Status light F Barcode label printer and applicator
B Control unit G Aliquoting module
C Tube type identification module H Output sorter
D Power switch I Recapping module
E Input sorter
wcobas 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 3.1
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 container with sealing foils.
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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Roche cobas p 612 LCP1 User guide

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User guide

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