Roche cobas p 512 User manual

cobas p 512 pre-analytical instrument
Operator’s Manual

cobas p 512
II Operator's Manual - Version 1.6 - 10/2015

cobas p 512
Operator's Manual - Version 1.6 - 10/2015 III
Manual version
Version
Creation date
1.0
June 2007
1.1
February 2008
1.3
September 2011
1.3.1
February 2012
1.3.2
April 2013
1.4
December 2013
1.5
February 2014
1.6
October 2015
Intended use
The cobas p 512 pre-analytical system and cobas p 512 CCM variant pre-analytical system
are computer controlled fully automatic systems for sorting of open and closed barcoded and
centrifuged sample tubes as well as decapping and recapping of such.
They further include modules for registration of barcoded sample tubes, liquid level and
sample quality detection.
In case of standalone use of the cobas p 512 pre-analytical system, the transfer of tubes,
processed on the cobas p 512 pre-analytical system, to any other workstation within the
laboratory is subject of validation performed by the laboratory itself.
Software compatibility
The Operator's Manual has been written for the cobas p 512 with software version 1.6.1 or
higher.
Copyrights
This manual is a product of Roche PVT GmbH.
All rights are reserved. No part of this manual may be reproduced in any form (print,
photocopy, microfilm or another procedure) or processed using electronic systems, copied
or distributed without the written permission of the company.
The company assumes no liability for any errors, omissions or damages resulting from the
use of the information contained in this manual.
Note: All of the product names contained in this manual are trademarks of the respective
companies. If the trademark symbols © or ® are not included, it cannot be assumed that the
name is an unregistered product name.
The content of this manual is subject to change without any communicative obligations by
the company.
Copyright© Roche PVT GmbH, Waiblingen 2014

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IV Operator's Manual - Version 1.6 - 10/2015
Norms and standards
The cobas p 512 sorting system conforms to the currently applicable directives of the
European Union. Compliance with all standards and legal obligations is guaranteed.
CE labeling corresponds to the EU directives 98/79/EU (IVD Directive).
The requirements, limits and tolerances stated in the following standards are complied with:
•DIN EN 61326 (EMC requirements for electrical laboratory instruments)
•DIN EN 61010-1 (Safety requirements for electrical laboratory instruments)
•DIN EN 60825-1 (Safety requirements for laser equipment)
The instrument complies with
IVD Directive 98/79/EC
Guarantee and warranty
Current guarantee information can be found in your purchase contract or by asking at your
appointed dealer.
Neither Roche PVT GmbH nor its subsidiaries assume any liability to the purchaser of this
product or any third parties for damages, losses, costs or expenses incurred by the purchaser
or third parties due to accident, misuse of the product or unapproved modifications, repairs
or improvements to the instrument.
Roche PVT GmbH assumes no liability for damages or disruptions resulting from the use of
options or accessories that are not original products or that do not have express approval
from Roche PVT GmbH.
Contact address
Manufacturer
Roche Diagnostics GmbH
Roche Professional Diagnostics
Sandhofer Strasse 116
D
-68305 Mannheim
Germany

cobas p 512
Operator's Manual - Version 1.6 - 10/2015 V
Table of contents
1. General information..............................................................................1-1
1.1. Preface..........................................................................................................1-1
1.2. Using the Operator’s Manual ...................................................................1-1
1.3. Screen graphics, signs and symbols ...................................................... 1-1
1.4. Abbreviations............................................................................................... 1-1
1.5. Hazards and precautionary measures ...................................................1-1
1.5.1 Safety instructions ........................................................................................................1-1
1.5.2 Warning labels on the unit ........................................................................................1-1
1.5.3 Notes on safety ..............................................................................................................1-1
1.5.4 Electrical safety ..............................................................................................................1-1
1.5.5 Samples.............................................................................................................................1-1
1.5.6 Laser exposure...............................................................................................................1-1
1.6. Preconditions for scanning a barcode................................................... 1-1
1.6.1 Barcode quality, printing and labeling material ................................................1-1
1.6.2 Specifications for the barcode labels....................................................................1-1
1.6.3 Placement of the barcode label...............................................................................1-1
1.6.4 Sample images of correct and incorrect barcode labels...............................1-1
1.7. Disposal of device ...................................................................................... 1-1
1.7.1 Information on Waste of Electrical and Electronic Equipment (WEEE)....1-1
2. System description ...............................................................................2-1
2.1. Introduction.................................................................................................. 2-1
2.1.1 Operator training...........................................................................................................2-1
2.1.2 Customer configuration..............................................................................................2-1
2.1.3 Specifications..................................................................................................................2-1
2.1.4 Level of automation......................................................................................................2-1
2.1.5 Device reliability.............................................................................................................2-1
2.2. Hardware description ................................................................................ 2-1
2.2.1 Schematic diagram.......................................................................................................2-1
2.2.2 System safety devices..................................................................................................2-1
2.2.3 Control unit......................................................................................................................2-1
2.2.4 QNX Computer...............................................................................................................2-1
2.2.5 QS I computer (optional)............................................................................................2-1
2.2.6 Input sorter ......................................................................................................................2-1
2.2.7 Tube transport (RT-Transport).................................................................................2-1
2.2.8 Tube recognition ...........................................................................................................2-1
2.2.9 Infrared liquid level detection (IR-LLD)................................................................2-1

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2.2.10 Laser liquid level detection (Laser-LLD)..............................................................2-1
2.2.11 Decapping module .......................................................................................................2-1
2.2.12 Recapping module (optional)...................................................................................2-1
2.2.13 Output sorter...................................................................................................................2-1
2.2.14 Signal lamp......................................................................................................................2-1
2.2.15 Operating modes...........................................................................................................2-1
2.2.16 Mains connection and system interfaces............................................................2-1
2.2.17 Compressed air connection ......................................................................................2-1
2.2.18 The waste container for the decapping module ...............................................2-1
2.2.19 Air pressure maintenance unit (interior)..............................................................2-1
2.3. Consumable material.................................................................................2-1
2.3.1 Sealing foils (optional) ................................................................................................2-1
2.4. Accessories..................................................................................................2-1
2.4.1 Carriers, racks and rack trays...................................................................................2-1
2.4.2 Compressor .....................................................................................................................2-1
2.4.3 Cleaning brush...............................................................................................................2-1
2.4.4 Cleaning sets ..................................................................................................................2-1
2.5. Sample flow and sample processing ..................................................... 2-1
2.5.1 The route that the sample takes through the system .....................................2-1
2.5.2 Processing profiles and priorities............................................................................2-1
2.5.3 Defining sorting racks.................................................................................................2-1
2.5.4 Processing open sample tubes................................................................................2-1
2.5.5 Processing recursive sample tubes........................................................................2-1
2.5.6 Processing multiple patient samples with the identical barcode ...............2-1
2.5.7 Archiving the sample tubes ......................................................................................2-1
2.6. Basic information about the software....................................................2-1
2.6.1 Structure of the software ...........................................................................................2-1
2.6.2 QNX operating system ................................................................................................2-1
2.6.3 Communication with the laboratory host computer........................................2-1
2.6.4 Graphic user interface.................................................................................................2-1
2.6.5 How to use the menu system...................................................................................2-1
2.6.6 Online Help......................................................................................................................2-1
2.6.7 System status and messages....................................................................................2-1
2.6.8 Error messages...............................................................................................................2-1
2.7. Software description.................................................................................. 2-1
2.7.1 Login and user rights...................................................................................................2-1
2.7.2 System test.......................................................................................................................2-1
2.7.3 Log out / shut down system .....................................................................................2-1
2.7.4 Structure of the menus ...............................................................................................2-1
2.7.5 Routine menu .................................................................................................................2-1
2.7.6 Routine – Control ..........................................................................................................2-1
2.7.7 Routine menu – Sorting lists.....................................................................................2-1
2.7.8 Routine menu – Information system......................................................................2-1

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2.7.9 Routine menu – Clear Data.......................................................................................2-1
2.7.10 Routine menu – Statistics ..........................................................................................2-1
2.7.11 Maintenance menu ......................................................................................................2-1
2.7.12 Maintenance menu – Error history.........................................................................2-1
2.7.13 Maintenance menu – Daily Backup.......................................................................2-1
2.7.14 Maintenance menu – Date, time, day ...................................................................2-1
3. Operation.................................................................................................3-1
3.1. Commissioning the system ...................................................................... 3-1
3.2. Daily routine................................................................................................. 3-1
3.2.1 Trouble-free operating procedures........................................................................3-1
3.3. Preparation................................................................................................... 3-1
3.3.1 Emptying the waste container..................................................................................3-1
3.3.2 Emptying the condensation container ..................................................................3-1
3.3.3 Inserting sealing foils for the recapper (optional)............................................3-1
3.3.4 Switching the system on ............................................................................................3-1
3.3.5 Login ..................................................................................................................................3-1
3.3.6 System test.......................................................................................................................3-1
3.3.7 Performing a reorganization .....................................................................................3-1
3.3.8 Selecting the work cycle (optional)........................................................................3-1
3.3.9 Loading the system ......................................................................................................3-1
3.4. Operation......................................................................................................3-1
3.4.1 Start sample processing.............................................................................................3-1
3.4.2 Interrupt sample processing .....................................................................................3-1
3.4.3 React to error messages.............................................................................................3-1
3.4.4 Input sorter during operation, with loaded samples, racks and trays ......3-1
3.4.5 Emptying and replacing full sorting racks...........................................................3-1
3.4.6 Processing urgent samples .......................................................................................3-1
3.4.7 Processing recursive samples ..................................................................................3-1
3.4.8 Sample tracking (position, processing status)...................................................3-1
3.4.9 Archive samples ............................................................................................................3-1
3.5. Terminating routine operation after daily routine ...............................3-1
3.5.1 Perform data backups.................................................................................................3-1
3.5.2 Logout/System, shutdown and switching off.....................................................3-1
3.5.3 Checking the sorting area and the work area ...................................................3-1
3.5.4 Emptying the waste container..................................................................................3-1
3.5.5 Care and maintenance procedures........................................................................3-1
4. Maintenance ..........................................................................................4-1
4.1. Device care and maintenance ................................................................. 4-1
4.2. Cleaning agents and equipment .............................................................4-1
4.3. Care and maintenance schedule ............................................................ 4-1
4.3.1 Preventative maintenance..........................................................................................4-1

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4.4. Weekly device care ....................................................................................4-1
4.4.1 Cleaning the decapper module ...............................................................................4-1
4.5. Monthly device maintenance...................................................................4-1
4.5.1 Cleaning system components ..................................................................................4-1
4.5.2 Cleaning the barcode reader....................................................................................4-1
4.5.3 Cleaning the sensors on the RT-Transport .........................................................4-1
4.5.4 Cleaning the infrared liquid level detection (IR-LLD).....................................4-1
4.5.5 Cleaning the laser liquid level detection (Laser-LLD) ....................................4-1
4.6. Device care, as and when required........................................................4-1
4.6.1 Cleaning the housing and component surfaces...............................................4-1
4.6.2 Cleaning the display.....................................................................................................4-1
4.6.3 Cleaning the sorting module grippers ..................................................................4-1
4.6.4 Cleaning the sensors on the feed-in and output modules ...........................4-1
4.6.5 Emptying the condensation container ..................................................................4-1
4.6.6 Cleaning the tube type identification module (BlueLynx camera).............4-1
4.6.7 Cleaning the quality module (QS I, QS I-LLD)...................................................4-1
4.6.8 Cleaning the recapper module ................................................................................4-1
4.7. Replacing parts ...........................................................................................4-1
4.7.1 Replacing the mains fuse...........................................................................................4-1
4.7.2 Replacing the lighting of tube type identification module............................4-1
5. Troubleshooting.....................................................................................5-1
5.1. What do I do if...? ........................................................................................5-1
5.1.1 ... the system is not working? ...................................................................................5-1
5.1.2 ... the control unit (computer) is not working? ..................................................5-1
5.1.3 ... the touch screen monitor is not working? ......................................................5-1
5.1.4 ... the communication in the network is not working?....................................5-1
5.1.5 ... the control unit (QNX PC) fails during operation?.......................................5-1
5.1.6 ... a power failure has occurred?.............................................................................5-1
5.1.7 ... no button is active on the touch screen monitor? .......................................5-1
5.1.8 ... daily data backup is causing problems?..........................................................5-1
5.1.9 ... the sorter unit does not put down the tubes properly? .............................5-1
5.1.10 ... problems occur when reading a barcode?.....................................................5-1
5.1.11 ... the recapping module is not working?.............................................................5-1
5.1.12 ... a tube is set down into an already-occupied position on the rack?.....5-1
5.1.13 ... the recapping module isn’t working? ...............................................................5-1
5.1.14 ... the decapper does not release the cap or is jammed?..............................5-1
5.1.15 ... the QS I camera fails to classify the sample? ................................................5-1
5.2. Important questions for customer service............................................ 5-1
5.2.1 General information .....................................................................................................5-1
5.2.2 Air pressure too low.....................................................................................................5-1
5.2.3 Problems with the motor control.............................................................................5-1
5.2.4 Problems with the tube transport at the in/ output sections .......................5-1

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5.2.5 If there are problems with the input sorter/output sorter .............................5-1
5.3. System and error messages..................................................................... 5-1
5.3.1 (Error) messages which require intervention.....................................................5-1
5.3.2 Informative messages..................................................................................................5-1
6. Appendix .................................................................................................6-1
6.1. Included in delivery.................................................................................... 6-1
6.2. cobas p 512 system, technical data ....................................................... 6-1
6.2.1 Dimensions and weight..............................................................................................6-1
6.2.2 Current and voltage supply.......................................................................................6-1
6.2.3 Compressed air supply................................................................................................6-1
6.2.4 Operating conditions ...................................................................................................6-1
6.2.5 Ambient climatic conditions .....................................................................................6-1
6.2.6 Noise levels......................................................................................................................6-1
6.2.7 Heat emission .................................................................................................................6-1
6.2.8 Color of module .............................................................................................................6-1
6.3. Barcode scanner, technical data ............................................................ 6-1
6.3.1 Readable barcodes.......................................................................................................6-1
6.3.2 The definition of readable barcodes......................................................................6-1
6.3.3 Calculating the barcode check digit......................................................................6-1
6.3.4 Maximum number of digits.......................................................................................6-1
6.4. BlueLynx camera, technical data ............................................................6-1
6.5. QS I / QS I-LLD system (optional), technical data.............................. 6-1
6.6. Recapping module (optional), technical data......................................6-1
6.7. System interfaces ....................................................................................... 6-1
6.8. Device reliability .........................................................................................6-1
6.9. Accessories..................................................................................................6-1
6.10. Consumable materials............................................................................... 6-1
6.11. Sample tubes............................................................................................... 6-1
6.11.1 Dimensions of allowed tube types: ........................................................................6-1
6.12. Floorplan .......................................................................................................6-1
6.13. Glossary ........................................................................................................6-1

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cobas p 512 Part A - General information
Operator's Manual - Version 1.6 - 10/2015 1-1
Part A
1. General information

Part A - General information cobas p 512
1-2 Operator's Manual - Version 1.6 - 10/2015

cobas p 512 Part A - General information
Operator's Manual - Version 1.6 - 10/2015 1-3
1. General information..............................................................................1-1
1.1. Preface..........................................................................................................1-5
1.2. Using the Operator’s Manual ...................................................................1-6
1.3. Screen graphics, signs and symbols ...................................................... 1-7
1.4. Abbreviations............................................................................................... 1-9
1.5. Hazards and precautionary measures .................................................1-11
1.5.1 Safety instructions ..................................................................................................... 1-11
1.5.2 Warning labels on the unit ..................................................................................... 1-11
1.5.3 Notes on safety ........................................................................................................... 1-20
1.5.4 Electrical safety ........................................................................................................... 1-20
1.5.5 Samples.......................................................................................................................... 1-20
1.5.6 Laser exposure............................................................................................................ 1-21
1.6. Preconditions for scanning a barcode.................................................1-22
1.6.1 Barcode quality, printing and labeling material ............................................. 1-22
1.6.2 Specifications for the barcode labels................................................................. 1-23
1.6.3 Placement of the barcode label............................................................................ 1-25
1.6.4 Sample images of correct and incorrect barcode labels............................ 1-27
1.7. Disposal of device ....................................................................................1-28
1.7.1 Information on Waste of Electrical and Electronic Equipment (WEEE). 1-28

Part A - General information cobas p 512
1-4 Operator's Manual - Version 1.6 - 10/2015

cobas p 512 Part A - General information
Operator's Manual - Version 1.6 - 10/2015 1-5
1.1. Preface
The cobas p 512 sorting system is a computer-controlled stand-alone device for sorting
barcoded sample tubes. It has an online connection to a laboratory computer (host).
It consists of the following components:
•Input sorter with sorting unit
•Tube transport
•Camera module with integrated barcode scanner for sample recognition
•Decapping module
•Output sorter with sorting unit
•Control unit
•Cap recognition for tube-type identification (optional)
•Recapping module (optional)
•QS I / QS I-LLD quality module (optional)
•Optional connection to automatic centrifuge unit
NOTICE
Read the Operator’s Manual with the utmost care and attention before using the system for the
first time. Particular attention should be paid to descriptions of hazards and precautions.
Failure to observe notes pertaining to risks and safety contained in this Operator’s Manual can
have serious implications for health and safety as well as result in material damage.

Part A - General information cobas p 512
1-6 Operator's Manual - Version 1.6 - 10/2015
1.2. Using the Operator’s Manual
This Operator's Manual is valid for cobas p 512 sorting system. It contains information for
system operators at the application level. The information contained in this manual is not
intended for administrators or service technicians.
NOTICE
Keep this manual in a safe place accessible to all operators of the system.
The Operator’s Manual is divided into the following sections:
Parts
Name
Contents
A
General information
Manual description, safety information
B
System description
System overview, description of the hardware,
description of the software, sample flow
C
Operation
Working with the system
D
Maintenance
Maintenance and cleaning instructions
E
Troubleshooting
Describing and remedying faults
F
Appendix
Glossary, technical details, index

cobas p 512 Part A - General information
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1.3. Screen graphics, signs and symbols
Screen displays are presented in the Operator's Manual as shown in the following example:
Figure 1-1: Screenshot
Command entries
A 15" touch screen monitor mounted on a swivel arm between the input sorter and the
output sorter is used to enter commands in the system. This manual depicts keyboard entries
and buttons as follows:
[ENTER]
[SCROLL UP]
[SCROLL DOWN]
[↑]
[↓]
[→]
[←]
↵
Scroll
Scroll
↑
←
→
↓

Part A - General information cobas p 512
1-8 Operator's Manual - Version 1.6 - 10/2015
Signs and Symbols
Various symbols are used in this manual for the localization and interpretation of
information. They are explained below.
[Tab]
Key (keyboard)
[OK]
Button (screen)
'Menu 1 
Menu 2'
Menu hierarchy in the so
ftware
Reference
This symbol references another section of the Operator's Manual.
NOTICE
Notice: This indicates advice which the operator should observe in order to guarantee optimal
operation of the unit.
CAUTION
Caution: This symbol indicates a potential hazard. If this warning is not
heeded, the system can be damaged.
WARNING
Warning: This symbol indicates a potential hazard. The operator may be at risk
if the warning is not heeded.
WARNING
Crush hazard: This symbol warns the operator not to reach inside areas where
there is a risk of injury from moving parts of the system.
WARNING
Risk of infection: This symbol warns of the risk from infectious samples.
WARNING
Mains voltage: This symbol warns of areas in which the mains voltage is
applied.

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1.4. Abbreviations
The table below contains an explanation of the abbreviations used in this manual.
Abbreviation
Meaning
A
Ampere
AC
Alternating current
AH
Ampere-hour
ASTM
American Society for Testing and Materials
CE
Communauté Européenne
CPU
Central Processing Unit
dB
Decibel
DI
Dynamic Interface
DIN
Deutsche Industrie Norm (German Industry Standard)
EC
European Community
EDP
Event Distribution Protocol
ElektroG
German law covering recycling of electrical and electronic equipment
EMC
Electro-magnetic Compatibility
EN
European Standard
EPROM
Erasable Programmable Read Only Memory
FCC
Food Chemicals Codex
GB
Gigabyte
GUI
Graphical User Interface
Hz
Hertz
I/O
Input/output
IEC
Integrated Electronic Component
ISM
Industrial, Scientific, Medical
IVD
In-Vitro Diagnostics
LED
Light Emitting Diode
LIS
Laboratory Information System
LLD
Liquid Level Detection
LPT
Line Printing Terminal
MB
Megabyte
MSL
Mean Sea Level
NAT
NW
Nominal width
PC
Personal Computer
PCR
Polymerase Chain Reaction
QNX
Operating system for the system software
QS I
Quality system I

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1-10 Operator's Manual - Version 1.6 - 10/2015
Abbreviation
Meaning
RAM
Random Access Memory
RAST
Radio-alergo-sorbent-Test
RJ45
Registered Jack 45
RS232/422
Recommended Standard 232/422
RTT
Transport conveyor for primary tubes
SI
Standard Interface
TCP/IP
Transmission Control Protocol/Internet Protocol
V
Volt
VA
Volt-Ampere