Roche Multiplate User manual

Multiplate®analyzer
Operator’s Manual
Version 3.0
Software version 2.05

Multiplate® analyzer
Roche Diagnostics
2Operator’s Manual · Version 3.0
Document information
Revision history
Edition notice This publication is intended for users of the Multiplate®analyzer.
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 documentation is divided into the following parts:
oPart A —System Description: The system description provides information on
how the analyzer is installed, on its safe operation, and on its hardware and
software.
oPart B — Operation: The operation part describes how to perform the various
tasks that are required when analyzing samples, and how to set up the analyzer.
oPart C — Maintenance: The maintenance part provides instructions on how to
ensure problem-free operation of the system.
oPart D — Troubleshooting: The troubleshooting part provides assistance on
how to react to messages that are displayed on screen and on how to deal with
exceptional situations.
qoKeep this Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use.
oThis Operator’s Manual should be easily accessible at all times.
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 in screenshots, such as tests,
results, or path names 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 © 2012–2019, F. Hoffmann-La Roche Ltd. All rights reserved.
Manual
version
Revision
version
Software
version
Revision date Change description
1.0 2.03.11 April 2012 First publication.
1.0 1.0 2.03.13 October 2012 Available languages changed
2.0 2.04 May 2013 Changes in the user interface
3.0 2.05 June 2019 LIS connectivity
Table 1 Revision history

Roche Diagnostics
Operator’s Manual · Version 3.0 3
Multiplate® analyzer
License information Multiplate®analyzer software is protected by contract law, copyright law, and
international treaties. Multiplate®analyzer 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 Multiplate®analyzer may include components or modules of commercial or open-
source software. Copyright and other notices and licensing information regarding
such Software programs can be found on the Multiplate®analyzer.
This open-source and commercial software and Multiplate®analyzer as a whole can
constitute a device regulated in accordance with applicable law. For more detailed
information, refer to the corresponding user documentation and labeling.
Note that the respective authorization is no longer valid according to the
corresponding legislation should any unauthorized changes be made to Multiplate®
analyzer.
Trademarks The following trademarks are acknowledged:
Multiplate is a trademark of Roche. Transferpette is a trademark of BRAND.
All other trademarks are the property of their respective owners.
Approvals The Multiplate®analyzer 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.
The Multiplate®analyzer is manufactured and tested according to the following
international standards:
oIEC 61326-2-6
o61010-1
o61010-2-101
Compliance with the applicable directive(s) is provided by means of the Declaration
of Conformity.
The following mark demonstrates compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU directives.

Multiplate® analyzer
Roche Diagnostics
4Operator’s Manual · Version 3.0
Contact address
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Germany

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Operator’s Manual · Version 3.0 5
Multiplate® analyzer
Table of contents
Document information 2
Contact address 4
Table of contents 5
Preface 7
System description
1 Safety
Safety classification 15
Safety precautions 16
Safety summary 18
Data security 24
Safety labels on the equipment 25
Disposal of the equipment 26
2 Installation
Setting up the analyzer 29
Unpacking the analyzer 30
Installing the analyzer 31
Setting up the software 34
Installing the electronic pipette 46
Installing the printer 48
Verifying the installation 52
3 Overview
Multiplate technology 55
Components 56
Electronic pipette 58
Technical specification 62
Consumables and accessories 64
4 Software
Introduction 67
Main screen 69
Menu options 76
Operation
5 Operation
Safety 101
Starting the analyzer 102
Using the electronic pipette 103
Performing a measurement 107
Result handling 130
Deleting orders from the worklist 134
Reconstituting reagents and preparing
aliquots 135
Multiplate system control 137
Shutting down the analyzer 145
6 Configuration
Passwords 149
Setting up a printer 150
Adjusting the internal control parameters for data
alarms 151
Configuring the analyzer 152
Changing the language 157
Editing test parameters 158
LIS configuration 161
Electronic QC 162
Maintenance
7 Maintenance
Overview 167
Cleaning and disinfecting the analyzer 168
Maintenance and cleaning of the electronic
pipette 169
Checking the proper functioning of the
printer 185
Checking the temperature 186
Troubleshooting
8 Troubleshooting
Dealing with exceptional situations 191
Troubleshooting the electronic pipette 198

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6Operator’s Manual · Version 3.0
Multiplate® analyzer

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Operator’s Manual · Version 3.0 7
Multiplate® analyzer
Preface
Intended use
The Multiplate (multiple platelet function) analyzer is an instrument designed for in-
vitro diagnostic use in hospitals and other medical and scientific institutions.
Symbols and abbreviations
Product names Except where the context clearly indicated otherwise, the following product names
and descriptors are used.
Symbols used in the publication The following symbols are used:
Symbols used on product
Abbreviations The following abbreviations are used:
Product name Descriptor
Multiplate®analyzer analyzer
Multiplate Transferpette electronic pipette or autopipette
Table 2 Descriptors
Symbol Comment
oList item
PStart of procedure
SEnd of procedure
UCross-reference
fNavigation path indication
QTip
Safety alert
Electrical and electronic equipment marked with this symbol are
covered by the European directive WEEE.
Table 3 Symbols used for easy recognition of information
Symbol Explanation
Date of manufacture
Global Trade Item Number.
Table 4 Symbols used on product

Multiplate® analyzer
Roche Diagnostics
8Operator’s Manual · Version 3.0
What is new in publication version 3.0
Safety In the following safety sections new safety statements have been added or existing
statements have been adapted:
uOperator qualification (p. 16)
uBarcode read errors (p. 20)
uPatient misidentification (p. 20)
uSharps, rough edges, and/or moving parts (p. 18)
uMalicious software and hacker attacks (p. 22)
uUnauthorized access (p. 22)
uData security (p. 24)
uData alarms (p. 141)
Roche-provided firewall Information about Roche-provided firewall added.
Barcode reader Information about hand-held barcode reader added.
Supported printers Installation information about the Lexmark MS310d printer added.
uInstalling the printer (p. 48)
Supported barcode types A list of supported barcode types was added.
uBarcodes (p. 63)
Service menu The Service menu was removed from the menu bar. All menu commands that are not
service related have been moved to the Configuration menu.
uConfiguration menu (p. 92)
Abbreviation Explanation
EC European community
EN European standard
HL7 Health level 7
IEC International electrical commission
IVD In vitro diagnostics
LIS Laboratory information system
LQC Liquid quality control
MEA Multiple electrode aggregometry
n/a Not applicable
PDF Portable document format
PNG Portable network graphics
QC Quality control
XML Extensible markup language
Table 5 Abbreviations used

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Operator’s Manual · Version 3.0 9
Multiplate® analyzer
LIS support and Worklist window LIS support was added. Use the new Worklist window to do the following:
oDownload orders from the LIS.
oAssign orders to channels.
oStart autopipette measurements.
oUpload results to the LIS.
oManage orders.
uWorklist (p. 81)
uPerforming measurements using the worklist (p. 107)
uSending results to LIS from measurements created on the analyzer (p. 128)
uDeleting orders from the worklist (p. 134)
The LIS communication is configured in the LIS configuration window.
uLIS configuration (p. 161)
Electronic QC Information about the Electronic QC window was added.
uElectronic QC (p. 95)
Reruns Use the worklist to rerun an order. Rerun orders are indicated in the Test field in the
Worklist window with Rerun and the rerun number (for example Rerun 1).
uRerunning an order (p. 129)
Result deletion Information on how to delete result data was added.
uDeleting result data (p. 133)
Multiplate passwords The purpose of the level 1 and level 2 Multiplate passwords has been changed: the
level 1 password is an operator password and the level 2 password is an administrator
password. Both passwords have different access levels for the configuration options.
uPasswords (p. 149)
Test ID A unique test ID used on the LIS was introduced.
uTest I D (p. 158)

Multiplate® analyzer
Roche Diagnostics
10 Operator’s Manual · Version 3.0
What is new in publication version 2.0
Main screen redesigned The main screen of the Multiplate software has been optimized and redesigned.
Target range added A target range has been added for each test. The target range can be displayed on the
main screen.
Graphic zoom factors expanded The zoom factors for the channel graphics have been extended to 6 levels covering up
to 600 AU.
Menus and windows restructured The Multiplate menus and the corresponding windows have been restructured. The
former Service menu has been split into two menus: Configuration for user
configuration tasks and Service for Roche Service tasks.
Multiplate tests Manufacturer defined tests cannot be edited anymore. Only user defined tests are
fully editable.
User interface terms reworked The terminology of the user interface terms (all the text that is visible on screen) has
been reworked and adapted to Roche standards.
Operating system changed to
Windows 7
The operating system has been changed to Windows 7 for new Multiplate
installations. The installation instruction has been changed accordingly.
Keyboard shortcuts updated Keyboard shortcuts have been updated for all menus.
Printer installation procedure Procedures for installing new printers have been added to the manual.

System description
1 Safety ................................................................................................................................................ 13
2 Installation ....................................................................................................................................... 27
3 Overview .......................................................................................................................................... 53
4 Software ............................................................................................................................................ 65

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Operator’s Manual · Version 3.0 13
Multiplate® analyzer 1 Safety
Table o f contents
Safety 1
In this chapter you find information about the safe operation of the equipment.
In this chapter Chapter 1
Safety classification ..............................................................................................................15
Safety precautions.................................................................................................................16
Operator qualification ...................................................................................................16
Safe and proper use of the analyzer .............................................................................16
Miscellaneous safety precautions.................................................................................17
Safety summary ....................................................................................................................18
Warning messages..........................................................................................................18
Sharps, rough edges, and/or moving parts...........................................................18
Electrical safety.........................................................................................................18
Biohazardous materials ...........................................................................................18
Waste..........................................................................................................................19
Fire .............................................................................................................................19
Use..............................................................................................................................20
Barcode read errors .................................................................................................20
Patient misidentification.........................................................................................20
Caution messages...........................................................................................................21
Reagents and other working solutions..................................................................21
Cross contamination of samples............................................................................21
Fatigue due to long hours of operation.................................................................21
Malfunction due to interfering electromagnetic fields .......................................21
Use..............................................................................................................................22
Malicious software and hacker attacks..................................................................22
Unauthorized access ................................................................................................22
Notices .............................................................................................................................23
Circuit breakers and fuses.......................................................................................23
Spillage.......................................................................................................................23
Data security .........................................................................................................................24
Cyber security and privacy awareness.........................................................................24
Data transfer and data entry on analyzer....................................................................24
Backup security ..............................................................................................................24

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14 Operator’s Manual · Version 3.0
1 Safety Multiplate® analyzer
Table o f contents
Safety labels on the equipment ...........................................................................................25
Disposal of the equipment ..................................................................................................26

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Operator’s Manual · Version 3.0 15
Multiplate® analyzer 1 Safety
Safety classification
Safety classification
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 hazard statements
rThe 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
rIndicates a hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION
Caution
rIndicates a hazardous situation which, if not avoided, could result in minor or moderate
injury.
NOTICE Notice
rIndicates a hazardous situation which, if not avoided, could result in damage to
equipment.
Important information that is not safety relevant is indicated by the following
symbol:
qTip
Indicates additional information on correct use or useful tips.

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1 Safety Multiplate® analyzer
Safety precautions
Safety precautions
Generic hazard statements
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
The intended users of the analyzer are appropriately trained healthcare professionals
operating the analyzer in a laboratory setting.
Operators are required to have a sound knowledge of relevant guidelines and
standards as well as the information and procedures contained in the Operator’s
Manual.
oDo not carry out operation and maintenance unless you have been trained by
Roche Diagnostics.
oCarefully follow the procedures specified in the Operator’s Manual for the
operation and maintenance of the analyzer.
oLeave maintenance, installation or service that is not described in the Operator’s
Manual to trained Roche Service representatives.
oFollow standard laboratory practices, especially when working with biohazardous
material.
oPerform regular security and privacy awareness trainings for staff handling
personal data in a compliant way and according to the privacy principles that are
mandatory by customer regulations.
Safe and proper use of the analyzer
Personal protective equipment oBe sure to wear appropriate protective equipment, including, but not limited to,
safety glasses with side shields, fluid resistant lab coat, and approved disposable
gloves.
oWear a face shield if there is a chance of splash or splatter.
Accuracy/precision of measured
results
An incorrect measuring result may lead to an error in diagnosis, therefore posing
danger to the patient.
oDo not use consumables that have exceeded their expiration date, otherwise
inaccurate data may be obtained.
oFor diagnostic purposes always assess the results in conjunction with the patient’s
medical history, clinical examination, and other findings.
Installation oLeave installation tasks that are not described in the Operator’s Manual to trained
Roche Service representatives.
oFollow the installation instructions carefully.
Operating conditions oOperation outside of the specified ranges may lead to incorrect results or
malfunction of the analyzer.
uSee Environmental conditions (p. 62).

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Operator’s Manual · Version 3.0 17
Multiplate® analyzer 1 Safety
Safety precautions
oUse the analyzer indoors only and avoid heat and humidity.
uSee Environmental conditions (p. 62).
oPerform maintenance according to the specified intervals to maintain the
required operating conditions for the analyzer.
oKeep the Operator’s Manual in a safe place to ensure that it is not damaged and
remains available for use. It must be easily accessible at all times.
Approved parts Use of non-approved parts or devices may result in malfunction and may render the
warranty null and void. Only use parts and devices approved by Roche.
Approved accessories Use of non-approved accessories may result in malfunction. Only use accessories
approved by Roche.
uSee Consumables and accessories (p. 64).
Third-party software Installation of any third-party software that is not approved by Roche Diagnostics
may result in incorrect behavior of the analyzer. Do not install any non-approved
software. Non-compliance will void the warranty.
uSee Setting up the software (p. 34).
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage may damage the analyzer or lead to
data loss. Perform regular backups of measurement results. Do not switch off power
while the computer equipment accesses the hard disk.
Analyzer unused for an extended
period of time
If the analyzer is not used for an extended period of time, it must be shut down and
switched off. Handle the reagents as described in their respective package inserts. For
further information, call your Roche Service representative.

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1 Safety Multiplate® analyzer
Safety summary
Safety summary
This safety summary contains the most important and general warning, caution, and
notice messages. Additionally, you will find specific safety information in the task
descriptions throughout the manual.
Warning messages
WARNING
List of warning messages
rBefore operating the analyzer, read the warning messages contained in this summary
carefully. Failure to observe them may result in death or serious injury.
Sharps, rough edges, and/or moving parts
WARNING
Personal injury and infection due to sharps, rough edges, and/or moving parts
Good Laboratory Practice can reduce the risk of injury. Be aware of your laboratory
environment, well-prepared, and follow the instructions for use. Some areas of the
instrument may have sharps, rough edges, and/or moving parts.
rWear personal protective equipment to minimize the risk of injury from bodily contact
with such parts, especially in less accessible areas, or while cleaning the instrument.
rYour personal protective equipment should be appropriate to the degree and type of
potential hazard, e.g. suitable lab gloves, eye protection, lab coat, and footwear.
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.
rDo not attempt to work in any electronic compartment.
rInstallation, service, and repair must only be performed by personnel authorized and
qualified by Roche.
rObserve the safety labels on the equipment.
Biohazardous materials
WARNING
Infection by samples and associated materials
Contact with samples containing material of human origin may result in infection. All
materials and mechanical components associated with samples of human origin are
potentially biohazardous.
rFollow standard laboratory practices, especially when working with biohazardous
material.
rBe sure to wear appropriate protective equipment, including, but not limited to, safety
glasses with side shields, fluid resistant lab coat, and approved disposable gloves.
rIf any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
rIf sample or waste solution comes into contact with your skin, wash it off immediately
with soap and water and apply a disinfectant. Consult a physician.

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Operator’s Manual · Version 3.0 19
Multiplate® analyzer 1 Safety
Safety summary
Waste
WARNING
Infection by waste solution
Contact with waste solution may result in infection. All materials and mechanical
components associated with the waste systems are potentially biohazardous.
rBe sure to wear protective equipment. Take extra care when working with protective
gloves; these can easily be pierced or cut which can lead to infection.
rIf any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
rIf waste solution comes into contact with your skin, wash it off immediately with water
and apply a disinfectant. Consult a physician.
rObserve the safety labels on the equipment.
WARNING
Contamination of the environment by liquid and solid waste
The waste of the analyzer is potentially biohazardous.
rWhen disposing of any waste, do so in accordance with the appropriate local
regulations.
Waste must be treated in accordance with the relevant laws and regulations. Any
substances contained in reagents, calibrators, and quality controls, which are legally
regulated for environmental protection, must be disposed of according to the
relevant water discharge facility regulations.
Fire
WARNING
Fire and explosion due to use of inflammable materials
Electric sparks from electronic equipment can ignite flammable liquids and gases.
rDo not operate the analyzer in the presence of flammable liquids or gases.
rDo not operate the electronic pipette in the presence of flammable liquids or gases.
rDo not use the electronic pipette in an atmosphere with a danger of explosion.
rDo not pipette highly flammable liquids.
WARNING
Fire and explosion due to inappropriate use of the electronic pipette
Inappropriate use of the electronic pipette or the batteries (short circuit, mechanical
damage, overheating, incorrect AC adapter, etc.) can lead to battery explosion.
rWhen handling batteries, always follow the descriptions given in this documentation.
WARNING
Fire and explosion due to use of non-appropriate batteries
Using the electronic pipette with non-appropriate batteries can lead to battery explosion.
rThe original battery must not be replaced with non-rechargeable batteries or
rechargeable batteries of other manufacturers.

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1 Safety Multiplate® analyzer
Safety summary
Use
WARNING
Personal injury and incorrect results due to inappropriate use
Inappropriate use of the electronic pipette may lead to personal injuries and incorrect
results.
rOnly use the electronic pipette for pipetting liquids that conform with the intended use
of the instrument and the environmental conditions defined in this documentation.
rAlways use the instrument in such a way that neither the user nor any other person is
endangered. Avoid splashes. Only use suitable vessels.
rDo not attempt to make any technical alterations. Do not dismantle the electronic
pipette any further than is described in the Operator’s Manual.
rDo not use force when handling any part of the electronic pipette.
Barcode read errors
WARNING
Patient misidentification due to barcode read errors
If a barcode is read incorrectly, this may lead to patient misidentification and therefore to
inappropriate therapy decisions.
Inadequate print size and/or quality of the barcode labels may lead to erroneous decoding.
rWhen creating patient barcodes, always adhere to the applicable international IEC/ISO
standards for the respective barcode symbology.
rIn particular, ensure that barcode size and print quality (as defined in ISO/IEC 15416
and 15415) are adequate.
rIn addition, every user must carry out a plausibility check on all data scanned into and
displayed by the analyzer.
Patient misidentification
WARNING
Patient misidentification due to entering a wrong patient or sample ID
If a wrong patient or sample ID is entered before sending a result to the LIS, this may lead
to patient misidentification and therefore to inappropriate therapy decisions.
rIn the Worklist window, use always a barcode reader to enter patient or sample IDs.
rIn the Worklist window, make sure to enter the correct patient or sample ID.