Roche cobas p 701 User manual

Type
User manual

This manual is also suitable for

cobas p 501 post-analytical unit
cobas p 701 post-analytical unit
Operator’s Manual
Version 1.11
Software version 1.11
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
2 Operator’s Manual · Version 1.11
Document information
Revision history
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. 14)
1.10 1.10 October 2019
u What is new in
publication version
1.10 (p. 14)
1.11 1.11 March 2021
u What is new in
publication version
1.11 (p. 13)
Table 1 Revision history
Roche Diagnostics
Operator’s Manual · Version 1.11 3
cobas p 501 / p 701 post-analytical unit
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.
Where to find information The Operator’s 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 accessible place.
CAUTION
Incident reporting
r Inform your Roche representative and your local competent authority about any serious
incidents which may occur when using this product.
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 © 2009-2021, 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.
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
4 Operator’s Manual · Version 1.11
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.
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.
For in vitro diagnostic use.
Complies with the provisions of the applicable EU Directives.
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
Operator’s Manual · Version 1.11 5
cobas p 501 / p 701 post-analytical unit
u
For details, see Refrigerant (p. 48).
Contact addresses
Roche affiliates A list of all Roche affiliates can be found at:
www.roche.com/about/business/roche_worldwide.htm
eLabDoc Electronic user documentation can be downloaded using the eLabDoc e-service on
Roche DiaLog:
www.dialog.roche.com
For more information, contact your local affiliate or Roche Service representative.
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
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
6 Operator’s Manual · Version 1.11
Roche Diagnostics
Operator’s Manual · Version 1.11 7
cobas p 501 / p 701 post-analytical unit
Table of contents
Document information 2
Contact addresses 5
Table of contents 7
Intended use 9
Symbols and abbreviations 9
What is new in publication version 1.11 13
What is new in publication version 1.10 14
What is new in publication version 1.9 14
What is new in publication version 1.8 15
What is new in publication version 1.7 15
What is new in publication version 1.6 15
System description
1 General safety information
Safety classifications 21
Safety precautions 22
Safety summary 24
Safety labels on the system 30
Emergency stop buttons 35
Disposal of the instrument 35
2Overview
Overview 39
Hardware upgrades 41
Operation 42
Workflows 44
User interface 46
Technical specifications 47
List of available accessories 50
3 Hardware
Main components 53
Doors and flaps 54
Touch screen 57
Rack handling 58
Tube handling 69
Stopper handling 72
Refrigerated sample store 75
Trays, racks and tubes 80
Status light 86
Emergency stop buttons 87
4 Software
Basic software elements 91
Overview work area 95
Workplace work area 100
Instrument work area 104
Configuration work area 109
5 Configuration
Overview 113
System tab 115
Application tab 118
RD5 rack number ranges tab 120
Issue report tab 129
Operation
6Workflow
Startup check 135
Daily routine 139
7 Operation
Safety 143
Operating the instrument 144
Maintenance
8 Maintenance
Safety information 179
Instrument maintenance 180
Troubleshooting
9 Troubleshooting
Safety 189
Opening the maintenance doors 190
Status indications 192
Alarms and messages 193
Issue reports 197
Refrigerated sample store 198
Condensation water 201
Restopper and destopper modules 202
Exception output 207
Connection unit 208
Recovery procedures 209
Glossary
10 Glossary
Index
Index 221
Revisions
Roche Diagnostics
8 Operator’s Manual · Version 1.11
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
Operator’s Manual · Version 1.11 9
cobas p 501 / p 701 post-analytical unit
Intended use
The cobas p 501 / p 701 post-analytical unit 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 cobas p 501 / p 701 post-analytical unit is intended for storage and management
of samples, to be used in the area of clinical chemistry, immuno chemistry,
coagulation, hematology, urinalysis, nucleic acid testing.
Restrictions in the US: In US blood screening / blood establishments:
o The LIS middleware interface is limited to Instrument Manager manufactured by
Data Innovations Llc. (510 (k) cleared).
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.
When the combined product name is used (cobas p 501 / p 701 post-analytical unit),
it always refers to both instruments, cobas p 501 post-analytical unit and cobas p 701
post-analytical unit.
Product name Descriptor
cobas p 501 / p 701 post-analytical unit
instrument
instrument
cobas p 501 and p 701 post-analytical unit
Instrument Software
software
cobas t conductive sample rack conductive sample rack
B-Gate Interface connection unit
Table 2 Product names
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
10 Operator’s Manual · Version 1.11
Symbols used in the publication
Symbols used on product
a Start of procedure
End of procedure
o List item
u 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.
Symbol Explanation
Global trade item number.
Catalog number
Serial number
Indicates that the equipment is suitable for
alternating current only; to identify relevant
terminals.
Table 3 Symbols used on product
Roche Diagnostics
Operator’s Manual · Version 1.11 11
cobas p 501 / p 701 post-analytical unit
Date of manufacture
Unique device identifier
Caution
Symbol Explanation
Table 3 Symbols used on product
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
12 Operator’s Manual · Version 1.11
Abbreviations
The following abbreviations are used:
Abbreviation Definition
AAmpère
ANSI American National Standards Institute
ca. Circa (about)
CCD Charge coupled device
CISPR Comité international spécial des perturbations radioélectriques
CSA Canadian Standards Association
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 Vo l t - a m p è r e
VAC Volt alternating current
WWatt
WEEE European directive on waste electrical and electronic equipment
Table 4 Abbreviations
Roche Diagnostics
Operator’s Manual · Version 1.11 13
cobas p 501 / p 701 post-analytical unit
What is new in publication version 1.11
Workf low settings The upper values for storage time and retrieval holding time have been adapted.
u
Workf low settings (p. 115)
Tray input and exception output
flaps
A notice statement was added not to pull on the tray input and exception output flaps
during opening.
u
To load samples for storage using the tray input (p. 150)
u To unload racks from the exception output (p. 157)
Condensation water In operating conditions above average temperature in combination with humidity at
70% and higher, condensation can build up especially around and in the refrigerated
sample store. Water can condensate on the walls and around the door which can
collect and form puddles on the floor.
u
Condensation water (p. 201)
General changes and
improvements
The following information was added as part of this version:
o Information about incident reporting
o Link to the worldwide list of Roche affiliates
o Download information about electronic user documentation
o Unique device identifier symbol
o List of available accessories
u
Document information (p. 2)
u Roche affiliates (p. 5)
u eLabDoc (p. 5)
u Symbols used on product (p. 10)
u List of available accessories (p. 50)
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
14 Operator’s Manual · Version 1.11
What is new in publication version 1.10
Safety In the following safety sections new safety statements have been added:
u
Sharps, rough edges, and/or moving parts (p. 24)
u Mechanical safety (p. 27)
Hardware upgrades The list of optional hardware components has been replaced by a list of available
hardware upgrades.
u
Hardware upgrades (p. 41)
Tray input f lap A caution about the safe handling of the tray input flap has been added.
u
Tray input (p. 59)
u Loading samples for storage (p. 149)
u Refilling the retrieval rack buffer (p. 159)
Door handles for sample store
door
The new door handle design for the sample store door has been added.
u
Opening, closing, and locking the sample store door (p. 77)
Tubes The list of supported primary and secondary tube types has been updated.
u
Tubes (p. 84)
Data protection A recommendation has been added to establish a policy governing the content of free
text fields to avoid the presence of personal data.
u
Issue reports (p. 197)
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. 35)
u Emergency stop buttons (p. 87)
u Recovering from an emergency stop (p. 211)
Rack position numbering 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. 181)
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.
Roche Diagnostics
Operator’s Manual · Version 1.11 15
cobas p 501 / p 701 post-analytical unit
What is new in publication version 1.8
cobas t conductive sample racks Conductive sample racks can now be stored.
Single diameter verification 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
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
STAT 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. 48)
cobas p 501 / p 701 post-analytical unit
Roche Diagnostics
16 Operator’s Manual · Version 1.11
System description
1 General safety information...............................................................................................................19
2 Overview ...........................................................................................................................................37
3 Hardware...........................................................................................................................................51
4 Software.............................................................................................................................................89
5 Configuration................................................................................................................................. 111
Roche Diagnostics
Operator’s Manual · Version 1.11 19
cobas p 501 / p 701 post-analytical unit 1 General safety information
Table of contents
General safety information 1
This chapter provides information about safe operation of the instrument.
In this chapter
Chapter
1
Safety classifications.............................................................................................................21
Safety precautions.................................................................................................................22
Operator qualification...................................................................................................22
Safe and proper use of the instrument ........................................................................22
Miscellaneous safety precautions.................................................................................23
Safety summary ....................................................................................................................24
Warning messages..........................................................................................................24
Sharps, rough edges, and/or moving parts...........................................................24
Electrical safety ........................................................................................................25
Optical safety............................................................................................................25
Biohazardous materials...........................................................................................25
Waste .........................................................................................................................26
Caution messages...........................................................................................................27
Incorrect results .......................................................................................................27
Mechanical safety.....................................................................................................27
Data security.............................................................................................................28
Notices.............................................................................................................................29
Moving parts.............................................................................................................29
Circuit breakers and fuses.......................................................................................29
Spillage ......................................................................................................................29
Safety labels on the system..................................................................................................30
Front view .......................................................................................................................30
Side views ........................................................................................................................32
Rear view.........................................................................................................................34
Emergency stop buttons ......................................................................................................35
Disposal of the instrument..................................................................................................35
Roche Diagnostics
20 Operator’s Manual · Version 1.11
1 General safety information cobas p 501 / p 701 post-analytical unit
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Roche cobas p 701 User manual

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