Page is loading ...
cobas p 512
pre-analytical system (64x)
Operator’s manual version 2.1
cobas p 512 pre-analytical system (64x)
Roche Diagnostics
2 Operator’s Manual · Version 2.1
Document information
Revision history
Edition notice This Operator’s Manual is for users of the cobas p 512 pre-analytical system.
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.
Intended use The cobas p 512 pre-analytical system is a computer controlled fully automatic
system for sorting of open and closed barcoded and centrifuged and non-centrifuged
sample tubes.
It includes modules for registration and de-capping of sample tubes, liquid level
detection and sample quality assessment (optional), as well as re-capping of sample
tubes (optional).
The cobas p 512 pre-analytical system is intended for use with analyzers that perform
tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology,
urinalysis, nucleic acid testing.
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.
Copyright © 2017, Roche Diagnostics GmbH. All rights reserved.
Off the shelf software Portions of the cobas p 512 pre-analytical system might include one or more Open
Source or Commercial Software programs. Copyright and other notices and licensing
information regarding such Software programs can be found on the cobas p 512 pre-
analytical system.
Trademarks The following trademarks are acknowledged:
COBAS is a trademark of Roche.
All other trademarks are the property of their respective owners.
Manual Version Software Version Revision date Changes
2.0 2.0.0 April 2016 First release
2.1 2.0.6 August 2017 Spin status detection
improvements and
re-labeling
Roche Diagnostics
Operator’s Manual · Version 2.1 3
cobas p 512 pre-analytical system (64x)
System approvals
The cobas p 512 pre-anaytical system meets the protection requirements specified in
IVD Directive 98/79/EC.
Compliance is demonstrated by the following marks:
Contact address
For in vitro diagnostic use.
Complies with the Directive 98/79/EC on in vitro
diagnostic medical devices
Issued by Intertek (Electrical Testing Lab) for the US and
Canada.
Manufacturer
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
cobas p 512 pre-analytical system (64x)
Roche Diagnostics
4 Operator’s Manual · Version 2.1
Roche Diagnostics
Operator’s Manual · Version 2.1 5
cobas p 512 pre-analytical system (64x)
Table of contents
General Information Part A
1 General information
Preface A–5
Using the operator’s manual A–5
Abbreviations A–8
Safety precautions A–9
Prerequisites for scanning a barcode A–23
System Description Part B
2 System description
Introduction B–7
Hardware description B–9
Consumable material B–31
Accessories B–36
Sample flow and sample processing B–38
Basic information about the software B–46
Software description B–52
Operation Part C
3Operation
Commissioning the system C–5
Daily routine C–5
Preparation C–12
Operation C–29
Terminating operation after daily routine C–48
Maintenance Part D
4Maintenance
Device care and maintenance D–5
Cleaning agents and equipment D–6
Care and maintenance schedule D–6
Weekly device care D–7
Monthly device maintenance D–16
Device care, as and when required D–20
Troubleshooting Part E
5 Troubleshooting
What do I do if ... E–5
Important questions for customer service E–15
System and error messages E–16
Appendix Part F
6 Appendix
Included in delivery F–5
Technical data F–6
Consumable materials F–10
Accessories F–11
Sample tubes F–11
Caps F–12
Racks F–13
Floorplan F–16
Glossary F–17
Roche Diagnostics
6 Operator’s Manual · Version 2.1
cobas p 512 pre-analytical system (64x)
Roche Diagnostics
Operator’s Manual · Version 2.1 A-3
cobas p 512 pre-analytical system (64x) 1 General information
Table of contents
General information
Preface ............................................................................................................................... A–5
Using the operator’s manual ......................................................................................... A–5
Units and conventions used in this document ..................................................... A–6
Screen graphics, signs and symbols ........................................................................ A–6
Command entries ............................................................................................... A–7
Safety symbols ........................................................................................................... A–7
Abbreviations ................................................................................................................... A–8
Safety precautions ........................................................................................................... A–9
Product IT security ................................................................................................... A–9
Operator qualification ............................................................................................ A–10
Warning labels on the system ............................................................................... A–11
Rating plate ........................................................................................................ A–13
Protective hoods ............................................................................................... A–14
Interlocks of protective hoods ........................................................................ A–14
Camera enclosure ............................................................................................. A–15
Input sorter (rear side) ..................................................................................... A–16
LASER-LLD ....................................................................................................... A–16
Decapper ............................................................................................................ A–17
Recapper ............................................................................................................. A–18
Maintenance doors ........................................................................................... A–19
Mains socket ...................................................................................................... A–19
Compressed air connection ............................................................................. A–20
Electrical safety ........................................................................................................ A–20
Samples ..................................................................................................................... A–20
Tubes ........................................................................................................................ A–21
Processing of open tubes ........................................................................................ A–21
LASER exposure ...................................................................................................... A–21
LASER-LLD ....................................................................................................... A–21
Barcode scanner ................................................................................................ A–22
In this chapter
Chapter
1
Roche Diagnostics
A-4 Operator’s Manual · Version 2.1
1 General information cobas p 512 pre-analytical system (64x)
Table of contents
Drawers .................................................................................................................... A–22
Sorting unit .............................................................................................................. A–22
Acrylic glass cover ................................................................................................... A–22
Prerequisites for scanning a barcode .......................................................................... A–23
Barcode quality, printing and labeling material ................................................. A–23
Barcode label ..................................................................................................... A–24
Specifications for the barcode labels .................................................................... A–25
Placement of the barcode label ............................................................................. A–27
Sample images of correct and incorrect barcode labels ..................................... A–29
Blood sample tubes with faulty or wrongly placed barcode labels ................... A–29
Disposal of device ................................................................................................... A–32
Information on waste of electrical and electronic equipment (WEEE) .... A–32
Roche Diagnostics
Operator’s Manual · Version 2.1 A-5
cobas p 512 pre-analytical system (64x) 1 General information
Preface
Preface
The cobas p 512 (64x) pre-analytical system is a computer controlled, stand-alone
system capable of sorting of barcoded sample tubes. The system operates with an
online connection to the LIS.
It consists of the following components:
o Input sorter with sorting unit
o Tube transport
o Barcode scanner
o Optical tube type identification (options: QSI full version, QSI-LLD-SI, TTI
camera)
o Decapping module
o Recapping module (optional)
o Output sorter with sorting unit (optional: with cobas connection module (CCM)
in the output sorter area)
o Control unit
Using the operator’s manual
This operator’s manual is valid for the cobas p 512 (64x) pre-analytical system. It
contains information for the system operators at the application level. The
information contained in this manual is not intended for administrators or service
technicians.
The operator’s manual is divided into the following sections:
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 notices 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.
NOTICE
Keep this manual in a safe place accessible to all operators of the system.
Part Label Contents
A General information Manual description, safety information
B System description System overview, description of the hardware,
description of the software, sample flow, reports
C Operation Working with the system
D Maintenance Maintenance and cleaning instructions
E Troubleshooting Describing and remedying faults
F Appendix Glossary, technical details
Roche Diagnostics
A-6 Operator’s Manual · Version 2.1
1 General information cobas p 512 pre-analytical system (64x)
Using the operator’s manual
Units and conventions used in this document
Visual cues are used to help locate and interpret information in this manual quickly.
This section explains formatting conventions used in this manual.
The following symbols are used:
Screen graphics, signs and symbols
Screen displays are presented in the operator’s manual as shown in the following
example:
Symbol Used for
a Start of procedure
End of procedure
o List item
e
Cross-reference
f Call-up (software reference)
Tip
Safety alert
Electrical and electronic equipment marked with this symbol are
covered by the European directive WEEE.
The symbol denotes that the equipment must not be disposed of in
the municipal waste system.
Figure A-1 Screenshot
Roche Diagnostics
Operator’s Manual · Version 2.1 A-7
cobas p 512 pre-analytical system (64x) 1 General information
Using the operator’s manual
Command entries
A 15" touch screen monitor mounted on a swivel arm between the input sorter and
the output sorter is used to program or control the system. This manual depicts
keyboard entries and buttons as follows:
Safety symbols
Throughout the operator’s manual, the safety instructions are labeled as follows:
Enter key
[ENTER]
Page up key
[PAGE UP]
Page down key
[PAGE DN]
Scroll up key
[ï‚]
Scroll down key
[]
Scroll right key
[ï‚®]
Scroll left key
[]
NOTICE
This symbol indicates advice that users should observe to ensure errors do not occur when
operating the system.
This symbol indicates a potential hazard. The operator or the system may be at risk if the
warning is not heeded.
CAUTION
Caution: Indicates a hazardous situation that, if not avoided, can result in injury to the
operator and/or damage to the system.
WARNING
Warning: Indicates a hazardous situation that, if not avoided, could result in death or
serious injury.
Roche Diagnostics
A-8 Operator’s Manual · Version 2.1
1 General information cobas p 512 pre-analytical system (64x)
Abbreviations
Abbreviations
The list below contains an explanation of the abbreviations used in this manual:
Abbreviation Meaning
AAmpere
AC Alternating Current
Ah Ampere hour
ASTM American Society for Testing and Materials
BGV Berufsgenossenschaftliche Vorschriften
CCM cobas connection module
CE Communauté Européenne
CPU Central Processing Unit
dB Decibel
DC Direct Current
DIN Deutsche Industrie Norm (German industry standard)
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
IVD In-Vitro Diagnostics
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
PE Protective Earth
PIO Parallel I-O Interface
PTT Primary Tube Transport
RAM Random Access Memory
RCM Rack Conveyor Module
RFM Rack Feed Module
RJ45 Registered Jack 45
Roche Diagnostics
Operator’s Manual · Version 2.1 A-9
cobas p 512 pre-analytical system (64x) 1 General information
Safety precautions
Safety precautions
Safety regulations IEC 61010-1 and the applicable national electrical safety guidelines
must be observed! Safe operation and reliability of the system can only be ensured if
o the electrical installation of the system meets appropriate IEC requirements.
o prescribed installation is performed by a trained expert.
o visual inspection, PE conductor test, insulation test and leakage current test are
carried out by a qualified electrician, if necessary (e.g. according to BGV A3 or
other applicable safety guidelines).
o the system is operated in accordance with the operating instructions.
Product IT security
RS232/422 Recommended Standard 232/422
TCP/IP Transmission Control Protocol/ Internet Protocol
VVolt
VA Volt-Ampere
WEEE Directive 2002/96/EG covering Waste of Electrical and Electronic
Equipment
Abbreviation Meaning
CAUTION
Pay attention to the following safety precautions!
If you ignore these precautions, you can suffer minor to moderate injury. Each precaution
is important.
CAUTION
Loss of data integrity or unavailability of the system due to malicious software or
unauthorized system access
To avoid infection of malicious software or the unauthorized misuse of the system, the
following recommendations are essential:
o Make sure other computers and services on the network (for example: the LIS,
archiving share or -service, backup share or -service) are properly secured and
protected against malicious software and unauthorized access.
o Laboratory IT is responsible for the security of their local area network, especially in
protecting it against malicious software and attacks. This protection might include
measures, such as a firewall, to separate the device from uncontrolled networks as well
as measures that ensure that the connected network is free of malicious code.
o Restrict physical access to the system and all attached IT infrastructure (computer,
cables, network equipment etc.).
Roche Diagnostics
A-10 Operator’s Manual · Version 2.1
1 General information cobas p 512 pre-analytical system (64x)
Safety precautions
Operator qualification
As a user, you are required to have sound knowledge of relevant safety precaution
guidelines and standards and of the information and procedures found in the
operator’s manual.
o Do not carry out any operation or maintenance procedures unless you are trained
to do so by Roche Diagnostics.
o Carefully follow the procedures specified in the operator’s manual for operation
and maintenance.
o Leave maintenance, installation, or service that is not described in the operator’s
manual to trained Roche Service representatives.
o Follow good laboratory practices, especially when working with biohazardous
material.
Roche Diagnostics
Operator’s Manual · Version 2.1 A-11
cobas p 512 pre-analytical system (64x) 1 General information
Safety precautions
Warning labels on the system
Warning labels are used to indicate potential safety hazards and point out any
remaining risk.
All warning labels on the module and in areas that can be accessed by the operator
are documented below.
ß
Figure A-2 Location of warning labels on the front side
Roche Diagnostics
A-12 Operator’s Manual · Version 2.1
1 General information cobas p 512 pre-analytical system (64x)
Safety precautions
Figure A-3 Location of warning labels on the rear side
Roche Diagnostics
Operator’s Manual · Version 2.1 A-13
cobas p 512 pre-analytical system (64x) 1 General information
Safety precautions
Rating plate
The rating plate is located on the lower rear side of the system besides the interface
block.
A Required voltage, frequency and power
consumption
B Serial number of the system
C Reference number (order number) of the
system
D Type of system
E Warning label F C/N key of the system
G Date of manufacture H Required mains fuse
Figure A-4 Rating plate
E
C
B
A
F
G
D
H
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 notices 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.
Roche Diagnostics
A-14 Operator’s Manual · Version 2.1
1 General information cobas p 512 pre-analytical system (64x)
Safety precautions
Protective hoods
A pinching hazard warning label is attached to each of the protective hoods on the
front of the system.
Interlocks of protective hoods
A biohazard warning label is attached besides each of the interlocks for the protective
hoods.
A Protective hood B Warning label
Figure A-5 Pinching hazard warning label
A
B
CAUTION
Pinching hazard!
Contact with moving parts may cause serious injury.
Do not reach into the running system without putting it in standby mode.
A Interlock B Warning label
Figure A-6 Biohazard warning label
A
B
WARNING
Risk of infection!
This warning label warns you of the potential hazards posed by sample material. Always
wear gloves when working on the system and comply with applicable laboratory
regulations.
/
