Roche cobas p 701 User manual

Type
User manual

This manual is also suitable for

cobas p 501 / p 701 post-analytical unit
Operator’s Manual
Version 1.9
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
2 Operator’s Manual · Version 1.9
Document information
Revision histor y
Edition notice This publication is intended for users of the cobas p 501 / p 701 post-analytical unit.
Every effort has been made to ensure that all the information contained in this
publication is correct at the time of publishing. However, the manufacturer of this
product may need to update the publication information as output of product
surveillance activities, leading to a new version of this publication.
Manual version Software version Revision date Changes
1.0 1.0 September 2009
1.1 1.1 May 2010 Improved user interface,
configuration, MPA
connection.
1.2 1.2 May 2011 Minor changes throughout
the manual.
1.3 1.3 August 2012 Status light changed.
New Workflow chapter.
Minor changes.
1.4 1.4 December 2013 User interface was
redesigned and procedures
were improved.
1.5 1.5 February 2015 Bidirectional transport line
function was introduced.
1.6 1.6 June 2015 Increased throughput due to
dynamic robot driver.
1.7 1.7 June 2016 Enhanced performance.
Support for STAT retrieval
racks.
Support for flexible archive
racks.
Fill level indication of the
error positions in the sample
store.
About button on the global
action bar.
1.7.1 1.7.2 May 2017 Intended use changed
1.8 1.8 September 2017 Support for cobas t
conductive sample racks.
Single diameter verification.
Single rack input shutter
collision situation can be
recovered.
Processing priority
depending on rack input
location.
Report global action button
replaced.
1.9 1.9 August 2018
u What is new in
publication version 1.9
(p. 10)
Table 1 Revision history
Roche Diagnostics
Operator’s Manual · Version 1.9 3
cobas p 501 / p 701 post-analytical unit
Where to find information The Operators Manual contains all information about the product.
CAUTION
General attention
To avoid serious or fatal injury, ensure that you are familiar with the system and safety
information before you use the system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument in a way that is not described in this publication.
r Store all publications in a safe and easily retrievable place.
Training Do not carry out operation tasks or maintenance actions unless you have received
training from Roche Diagnostics. Leave tasks that are not described in the user
documentation to trained Roche Service representatives.
Images The screenshots and hardware images in this publication have been added exclusively
for illustration purposes. Configurable and variable data visible therein must not be
used for laboratory purposes.
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.
Always leave software updates to a Roche Service representative, or perform such
updates with their assistance.
Copyright © 2009-2018, F. Hoffmann-La Roche Ltd. All rights reserved.
License information cobas p 501 / p 701 post-analytical unit software is protected by contract law,
copyright law, and international treaties. cobas p 501 / p 701 post-analytical unit
contains a user license between F. Hoffmann-La Roche Ltd. and a license holder, and
only authorized users may access the software and use it. Unauthorized use and
distribution may result in civil and criminal penalties.
Open-source and commercial
software
cobas p 501 / p 701 post-analytical unit may include components or modules of
commercial or open-source software. For further information on the intellectual
property and other warnings, as well as licenses pertaining to the software programs
included in cobas p 501 / p 701 post-analytical unit, refer to the electronic
distribution included with this product.
This open-source and commercial software and cobas p 501 / p 701 post-analytical
unit as a whole can constitute a device regulated in accordance with applicable law.
For more detailed information, refer to the Operator’s Manual and labeling.
Note that the respective authorization is no longer valid according to the
corresponding legislation should any unauthorized changes be made to
cobas p 501 / p 701 post-analytical unit.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS P, and LIFE NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective owners.
Feedback Every effort has been made to ensure that this publication fulfills the intended use. All
feedback on any aspect of this publication is welcome and is considered during
updates. Contact your Roche representative, should you have any such feedback.
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
4 Operator’s Manual · Version 1.9
Approvals cobas p 501 / p 701 post-analytical unit meets the requirements laid down in:
Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices.
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011
on the restriction of the use of certain hazardous substances in electrical and
electronic equipment.
Compliance with the applicable directive(s) is provided by means of the Declaration
of Conformity.
The following marks demonstrate compliance:
Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the hermetically sealed
refrigeration.
The insulation of the chamber includes foam blown with fluorinated greenhouse gas.
u For details, see Re frigerant (p. 42).
Contact addresses
For in vitro diagnostic use.
Complies with the IVD directive 98/79/EC of the European
Parliament and of the Council of 27 October 1998 on in vitro
diagnostic medical devices.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the
US.
'Laboratory Equipment' is the product identifier as shown on the type
plate.
CUS
®
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Distributed in the USA by:
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
USA
Made in Switzerland
Roche Diagnostics
Operator’s Manual · Version 1.9 5
cobas p 501 / p 701 post-analytical unit
Table of contents
Document information 2
Contact addresses 4
Table of contents 5
Intended use 7
Symbols and abbreviations 7
What is new in publication version 1.9 10
What is new in publication version 1.8 10
What is new in publication version 1.7.1 10
What is new in publication version 1.7 11
What is new in publication version 1.6 11
System description
1 General safety information
Safety classifications 17
Safety precautions 18
Safety summary 20
Safety labels on the system 25
Emergency stop buttons 30
Disposal of the instrument 30
2 Overview
Overview 33
Hardware variants 35
Operation 36
Workflows 38
User interface 40
Technical specifications 41
3 Hardware
Main components 47
Doors and flaps 48
Touch screen 51
Rack handling 52
Tube handling 63
Stopper handling 66
Refrigerated sample store 69
Trays, racks and tubes 74
Status light 81
Emergency stop buttons 82
4 Software
Basic software elements 85
Overview work area 89
Workplace work area 94
Instrument work area 98
Configuration work area 103
5 Configuration
Overview 107
System tab 109
Application tab 112
RD5 rack number ranges tab 114
Issue report tab 123
Operation
6 Workflow
Startup check 129
Daily routine 133
7 Operation
Safety 137
Operating the instrument 138
Maintenance
8 Maintenance
Safety information 173
Instrument maintenance 174
Troubleshooting
9 Troubleshooting
Safety 183
Opening the maintenance doors 184
Status indications 186
Alarms and messages 187
Issue reports 191
Refrigerated sample store 192
Restopper and destopper modules 195
Exception output 200
Connection unit 201
Recovery procedures 202
Glossary
10 Glossary
Index
Index 213
Revisions
Roche Diagnostics
6 Operator’s Manual · Version 1.9
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
Operator’s Manual · Version 1.9 7
cobas p 501 / p 701 post-analytical unit
Intended use
The cobas p 501 / p 701 instrument stores primary and secondary sample tubes. The
tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for
add-on testing is possible at any time. Expired samples are disposed of automatically
when their storage time has elapsed. The instrument is intended as accessory for
diagnostic use.
The cobas p 501 / p 701 instrument is intended for use in the area of clinical
chemistry, immunochemistry, coagulation, hematology, urinalysis, and nucleic acid
testing.
Restrictions in the US: In US blood establishments:
o The LIS middleware interface is limited to 510(k) cleared Data Innovation (DI).
o The product must be operated in standalone mode (no physical connection to
automation systems and class II devices)
Symbols and abbreviations
Product names
Except where the context clearly indicates otherwise, the following product names
and descriptors are used.
Symbols used in the publication
Product name Descriptor
cobas p 501 / p 701 post-analytical unit
instrument
instrument
cobas p 501 / p 701 post-analytical unit
software
software
cobas t conductive sample rack conductive sample rack
Table 2 Product names
a Start of procedure
End of procedure
o List item
u Cross-reference
f Call-up (software reference)
Tip
Safety alert
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
8 Operator’s Manual · Version 1.9
Symbols used on product
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.
Symbol Explanation
Global trade item number.
Catalog number
Serial number
Indicates that the equipment is suitable for
alternating current only; to identify relevant
terminals.
Date of manufacture
Caution
Table 3 Symbols used on product
Roche Diagnostics
Operator’s Manual · Version 1.9 9
cobas p 501 / p 701 post-analytical unit
Abbreviations
The following abbreviations are used:
Abbreviation Definition
A Ampère
ANSI American National Standards Institute
ca. Circa (about)
CCD Charge coupled device
CISPR Comité international spécial des perturbations radioélectriques
CSA Canadian Standards Associantion
e.g. Exempli gratia – for example
EC European community
EN European standard
Hz Hertz
i.e. Id est – that is to say
IEC International Electrical Commission
IVD In vitro diagnostic
IT Information technology
LLiter
LIS Laboratory information system
mm Millimeter
MPA Modular Pre- or Post-Analytics
nm Nanometer
RF Radio frequency
STAT Short turn around test
TÜV Technischer Überwachungsverein
UL Underwriters Laboratories Inc.
UPS Uninterrupted power supply
VVolt
VA Volt-ampère
VAC Volt alternating current
WWatt
WEEE European directive on waste electrical and electronic equipment
Table 4 Abbreviations
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
10 Operator’s Manual · Version 1.9
What is new in publication version 1.9
Emergency buttons The use and effect of the emergency buttons has been updated. To release the
emergency button on the sample store, turn it clockwise.
u Emergency stop buttons (p. 30)
u Emergency stop buttons (p. 82)
u Recovering from an emergency stop (p. 204)
Rack position numbe r ing The rack position numbering on the tube transfer area and the storage rack parking
area have been clearly indicated.
Maintenance schedule A maintenance schedule was added.
u Maintenance schedule (p. 175)
Product names The product names have been aligned throughout this publication.
General changes and
improvements
General changes and improvements have been made throughout this publication.
What is new in publication version 1.8
cobas t conductive sample racks Conductive sample racks can now be stored.
Single diameter ver ification The instrument can be set up to allow 13 mm or 16 mm tubes only. Tubes with
different diameters would be rejected.
Single rack input collision In the single rack input, should the shutter jam because you inserted the rack too
early, you have 3 seconds to retrieve the rack. You can then re-insert the rack.
Processing priority Rack processing is prioritized according to where they were loaded: 1: single rack
input, 2: connection unit, 3: tray input.
Issue report button The Report global action button was replaced.
What is new in publication version 1.7.1
The intended use of the instrument was changed.
Roche Diagnostics
Operator’s Manual · Version 1.9 11
cobas p 501 / p 701 post-analytical unit
What is new in publication version 1.7
Increased throughput Throughput was improved both for storing and retrieval.
Flexible archive racks The flexible archive rack provides more flexibility for storing.
Rack input Rack processing is prioritized according to the input location:
1. Single rack input
2. Input line
3. Tray input
ST A T racks Support for dedicated STAT retrieval racks.
Overview tab o About button on the global action bar.
o Fill level indication of the error positions in the sample store.
o The instrument is fully identified with name and serial number.
Disposal You can delete manual disposal orders.
Issue report Improved Issue report screen. Screen closes automatically when the report is created.
What is new in publication version 1.6
Increased throughput Increased throughput due to dynamic robot driver.
u Throughput (p. 42)
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
12 Operator’s Manual · Version 1.9
System description
1 General safety information .............................................................................................................. 15
2 Overview .......................................................................................................................................... 31
3 Hardware.......................................................................................................................................... 45
4 Software............................................................................................................................................ 83
5 Configuration ................................................................................................................................. 105
Roche Diagnostics
Operator’s Manual · Version 1.9 15
cobas p 501 / p 701 post-analytical unit 1 General safety information
Table of c o nt e nts
General safety information 1
This chapter provides information about safe operation of the instrument.
In this chapter
Chapter
1
Safety classifications.............................................................................................................17
Safety precautions.................................................................................................................18
Operator qualification...................................................................................................18
Safe and proper use of the instrument ........................................................................18
Miscellaneous safety precautions.................................................................................19
Safety summary ....................................................................................................................20
Warning messages..........................................................................................................20
Electrical safety.........................................................................................................20
Optical safety............................................................................................................20
Biohazardous materials...........................................................................................21
Waste..........................................................................................................................21
Caution messages...........................................................................................................22
Incorrect results .......................................................................................................22
Mechanical safety.....................................................................................................22
Data security.............................................................................................................23
Notices.............................................................................................................................24
Moving parts.............................................................................................................24
Circuit breakers and fuses.......................................................................................24
Spillage.......................................................................................................................24
Safety labels on the system..................................................................................................25
Front view .......................................................................................................................25
Side views ........................................................................................................................27
Rear view.........................................................................................................................29
Emergency stop buttons ......................................................................................................30
Disposal of the instrument..................................................................................................30
Roche Diagnostics
16 Operator’s Manual · Version 1.9
1 General safety information cobas p 501 / p 701 post-analytical unit
Table of c o nt e nts
Roche Diagnostics
Operator’s Manual · Version 1.9 17
cobas p 501 / p 701 post-analytical unit 1 General safety information
Safety classifications
Safety classifications
This section explains how precautionary information is presented in this manual.
The safety precautions and important user notes are classified according to the
ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons:
Generic safety precaution
r The safety alert symbol by itself without a signal word is used to promote awareness to
hazards which are generic or to direct the reader to safety information provided
elsewhere in the document.
These symbols and signal words are used for specific hazards:
WARNING
WARNING
r Indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION
CAUTION
r Indicates a hazardous situation which, if not avoided, could result in minor or moderate
injury.
NOTICE
NOTICE
r Indicates a hazardous situation which, if not avoided, could result in damage to
equipment.
u For more information about the product safety labels, see Safety labels on the system
(p. 25)
Important information which is not safety relevant is indicated by the following
symbol:
q
Tip
Indicates additional information on correct use of the instrument or useful tips.
Roche Diagnostics
18 Operator’s Manual · Version 1.9
1 General safety information cobas p 501 / p 701 post-analytical unit
Safety precautions
Safety precautions
Generic safety precautions
r Particular attention must be paid to the following safety precautions. If these safety
precautions are ignored, the operator may suffer serious or fatal injury. Each
precaution is important.
Operator qualification
Operators are required to have a sound knowledge of relevant guidelines and
standards as well as the information and procedures contained in the Operators
Manual.
o Do not carry out operation and maintenance unless you have been trained by
Roche Diagnostics.
o Carefully follow the procedures specified in the Operator’s Manual for the
operation and maintenance of the instrument.
o Leave maintenance, installation or service that is not described in the Operator’s
Manual to trained Roche Service personnel.
o Follow standard laboratory practices, especially when working with biohazardous
material.
Safe and proper use of the instrument
Pers onal protective equipment o Be sure to wear appropriate protective equipment, including, but not limited to,
safety glasses with side shields, fluid resistant lab coat, and approved disposable
gloves.
o Wear a face shield if there is a chance of splash or splatter.
Installation o Installation must be performed by trained Roche Service personnel only.
o Leave installation that is not described in the Operator’s Manual to trained Roche
Service personnel. Follow the described installation instructions carefully.
Operating c onditions o Operation outside of the specified ranges may lead to incorrect results or
malfunction of the instrument.
u Environmental conditions (p. 41)
o Use the instrument indoors only and avoid heat and humidity.
o Make sure that the instrument's ventilation openings remain unobstructed at all
times.
o Perform maintenance according to the specified intervals to maintain the
operating conditions of the instrument.
o Keep the Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use. This manual must be easily accessible at all times.
Approve d parts Use of non-approved parts or devices may result in malfunction of the instrument
and may render the warranty null and void. Only use parts and devices approved by
Roche Diagnostics.
Roche Diagnostics
Operator’s Manual · Version 1.9 19
cobas p 501 / p 701 post-analytical unit 1 General safety information
Safety precautions
Third-party software Installation of any third-party software that is not approved by Roche Diagnostics
may result in incorrect behavior of the instrument. Do not install any non-approved
software.
Third-party materials The use of any third-party materials that are not approved by Underwriters
Laboratories Inc. (UL) may result in malfunction of the instrument. Only use UL
certified supplies.
Data security Malicious software or unauthorized system access can result in data loss or system
unavailability.
To avoid infection by malicious software or the unauthorized access and misuse of
the system, the following recommendations are essential:
o Do not connect any external storage devices (such as USB flash drives or external
hard drives) to the system.
o Do not install and/or execute any other software on the system.
o Make sure other computers and services on the network (for example, the LIS,
archiving, backup share, or service) are properly secured and protected against
malicious software and unauthorized access.
o Customers are 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 A Windows firewall is part of the system and active.
o Restrict physical access to the system and all attached IT infrastructure
(computer, cables, network equipment, etc.).
o Make sure that system backup and archive files are protected from any
unauthorized access and disaster, this includes: remote storage location; disaster
recovery sites; secure transfer of backup files.
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage may damage the instrument or lead to
data loss. Do not switch off power while the PC accesses the hard disk.
Electromagnetic fields This instrument has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
o The electromagnetic environment should be evaluated prior to operation of the
device.
o Do not operate this instrument in close proximity to sources of strong
electromagnetic fields (for example unshielded intentional RF sources), as these
may interfere with the proper operation.
Devices that emit electromagnetic waves may cause the instrument to malfunction.
Do not operate the following devices in the same room where the instrument is
installed:
o Mobile phone
o Transceiver
o Cordless phone
o Other electrical devices that generate electromagnetic fields
Roche Diagnostics
20 Operator’s Manual · Version 1.9
1 General safety information cobas p 501 / p 701 post-analytical unit
Safety summary
Relocation and transportation Do not attempt to relocate or transport the instrument. Leave relocation and
transportation to personnel trained or authorized by Roche.
u For information about disposal of the instrument, see: Disposal of the instrument (p. 30)
Safety summary
This safety summary contains the most important and general warning and caution
messages. Additionally, you will find specific safety information at the beginning of
chapters Operation and Maintenance.
Warning messages
WARNING
List of warning messages
r Before operating the instrument, read the warning messages contained in this
summary carefully. Failure to observe them may result in death or serious injury.
Electrical safety
WARNING
Electrical shock by electronic equipment
Removing the covers of electronic equipment can cause electric shock, as there are high
voltage parts inside.
r Do not attempt to work in any electronic compartment.
r Do not remove or open any cover of the instrument other than those specified in this
Operator’s Manual.
r Installation, service, and repair must only be performed by personnel authorized and
qualified by Roche.
r Observe the system safety labels.
Optical safety
WARNING
Loss of sight due to staring into laser beam
The intense light of the laser equipment may severely damage your eyes.
The instrument is equipped with three barcode scanners (rack, tube, and storage rack
barcode scanner) and two laser proximity switches (located on the storage rack barcode
handler in the sample store). The barcode scanners and laser proximity switches contain a
class II laser diode.
r Do not stare into laser transmitter beam as eyesight may be severely damaged.
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