Roche Multiplate 5 Analyzer User manual

Multiplate

®

analyzer

Operator’s Manual

Version 3.0

Software version 2.05

Multiplate® analyzer

Roche Diagnostics

2 Operator’s Manual · Version 3.0

Document information

Revision histor y

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:

o Part A — System Description: The system description provides information on

how the analyzer is installed, on its safe operation, and on its hardware and

software.

o Part 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.

o Part C — Maintenance: The maintenance part provides instructions on how to

ensure problem-free operation of the system.

o Par t 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.

q

o Keep this Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use.

o This 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.

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:

o IEC 61326-2-6

o 61010-1

o 61010-2-101

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

4 Operator’s Manual · Version 3.0

Contact address

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Germany

Roche Diagnostics

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

Roche Diagnostics

6 Operator’s Manual · Version 3.0

Multiplate® analyzer

Roche Diagnostics

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

Multiplate Transferpette electronic pipette or autopipette

Table 2 Descriptors

Symbol Comment

o List item

P Start of procedure

S End of procedure

U Cross-reference

f Navigation path indication

Q Tip

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

8 Operator’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:

u Operator qualification (p. 16)

u Barcode read errors (p. 20)

u Patient misidentificatio n (p. 20)

u Sharps, rough edges, and/or moving parts (p. 18)

u Malicious software and hacker attacks (p. 22)

u Unauthorized access (p. 22)

u Data security (p. 24)

u Data 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.

u Installing the printer (p. 48)

Supported barcode types A list of supported barcode types was added.

u Barcodes (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.

u Configuration 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

Roche Diagnostics

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:

o Download orders from the LIS.

o Assign orders to channels.

o Start autopipette measurements.

o Upload results to the LIS.

o Manage orders.

u Worklist (p. 81)

u Performing measurements using the worklist (p. 107)

u Sending results to LIS from measurements created on the analyzer (p. 128)

u Deleting orders from the worklist (p. 134)

The LIS communication is configured in the LIS configuration window.

u LIS configuration (p. 161)

Electronic QC Information about the Electronic QC window was added.

u Electronic 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).

u Rerunning an order (p. 129)

Result deletion Information on how to delete result data was added.

u Deleting result data (p. 133)

M ul tiplate 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.

u Passwords (p. 149)

Test ID A unique test ID used on the LIS was introduced.

u Test ID (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 a dded A target range has been added for each test. The target range can be displayed on the

main screen.

Graphic zoom factors ex panded 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

Roche Diagnostics

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

Roche Diagnostics

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

Roche Diagnostics

Operator’s Manual · Version 3.0 15

Multiplate® analyzer 1 Safety

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

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.

Important information that is not safety relevant is indicated by the following

symbol:

q

Tip

Indicates additional information on correct use or useful tips.

Roche Diagnostics

16 Operator’s Manual · Version 3.0

1 Safety Multiplate® analyzer

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.

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 analyzer.

o Leave maintenance, installation or service that is not described in the Operator’s

Manual to trained Roche Service representatives.

o Follow standard laboratory practices, especially when working with biohazardous

material.

o Perform 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

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.

Accuracy/precision of measured

results

An incorrect measuring result may lead to an error in diagnosis, therefore posing

danger to the patient.

o Do not use consumables that have exceeded their expiration date, otherwise

inaccurate data may be obtained.

o For diagnostic purposes always assess the results in conjunction with the patient’s

medical history, clinical examination, and other findings.

Installation o Leave installation tasks that are not described in the Operator’s Manual to trained

Roche Service representatives.

o Follow the installation instructions carefully.

Operating conditions o Operation outside of the specified ranges may lead to incorrect results or

malfunction of the analyzer.

u See Environmental conditions (p. 62).

Roche Diagnostics

Operator’s Manual · Version 3.0 17

Multiplate® analyzer 1 Safety

Safety precautions

o Use the analyzer indoors only and avoid heat and humidity.

u See Environmental conditions (p. 62).

o Perform maintenance according to the specified intervals to maintain the

required operating conditions for the analyzer.

o Keep 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.

Approve d 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.

u See 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.

u See 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.

Roche Diagnostics

18 Operator’s Manual · Version 3.0

1 Safety Multiplate® analyzer

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

r Before 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.

r Wear 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.

r Your 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.

r Do not attempt to work in any electronic compartment.

r Installation, service, and repair must only be performed by personnel authorized and

qualified by Roche.

r Observe 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.

r Follow standard laboratory practices, especially when working with biohazardous

material.

r 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.

r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

r If 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.

Roche Diagnostics

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.

r Be 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.

r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

r If waste solution comes into contact with your skin, wash it off immediately with water

and apply a disinfectant. Consult a physician.

r Observe the safety labels on the equipment.

WARNING

Contamination of the environment by liquid and solid waste

The waste of the analyzer is potentially biohazardous.

r When 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.

r Do not operate the analyzer in the presence of flammable liquids or gases.

r Do not operate the electronic pipette in the presence of flammable liquids or gases.

r Do not use the electronic pipette in an atmosphere with a danger of explosion.

r Do 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.

r When 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.

r The original battery must not be replaced with non-rechargeable batteries or

rechargeable batteries of other manufacturers.

Roche Diagnostics

20 Operator’s Manual · Version 3.0

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.

r Only use the electronic pipette for pipetting liquids that conform with the intended use

of the instrument and the environmental conditions defined in this documentation.

r Always use the instrument in such a way that neither the user nor any other person is

endangered. Avoid splashes. Only use suitable vessels.

r Do not attempt to make any technical alterations. Do not dismantle the electronic

pipette any further than is described in the Operator’s Manual.

r Do 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.

r When creating patient barcodes, always adhere to the applicable international IEC/ISO

standards for the respective barcode symbology.

r In particular, ensure that barcode size and print quality (as defined in ISO/IEC 15416

and 15415) are adequate.

r In 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.

r In the Worklist window, use always a barcode reader to enter patient or sample IDs.

r In the Worklist window, make sure to enter the correct patient or sample ID.

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Roche Multiplate 5 Analyzer User manual

Roche Multiplate 5 Analyzer User manual

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