Roche Multiplate 5 Analyzer User manual

Multiplate

®

analyzer

Operator’s Manual version 4.0

Software version 2.06

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

2

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:

• 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.

• 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.

• Part C — Maintenance: The maintenance part

provides instructions on how to ensure problem-free

operation of the system.

• Part 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 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.

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

4.0 2.06 April 2020 Windows 10 operating system

New layout

Kiosk mode

Supported printer

Menu items

y Revision history

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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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.

reserved.

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:

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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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:

• IEC 61326-2-6

• 61010-1

• 61010-2-101

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following mark demonstrates compliance:

Contact address

For in vitro diagnostic use.

Complies with the provisions of the applicable EU directives.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Germany

Table of contents 5

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

Table of contents

Document information 2

Contact address 4

Table of contents 5

Preface 7

Intended use 7

Symbols and abbreviations 7

What is new in publication version 4.0 9

What is new in publication version 3.0 10

What is new in publication version 2.0 12

System description

1Safety

Safety classification 17

Safety precautions 18

Safety summary 21

Data security 30

Safety labels on the equipment 31

Disposal of the equipment 32

2 Installation

Setting up the analyzer 35

Unpacking the analyzer 35

Installing the analyzer 36

Setting up the software 38

Installing the electronic pipette 41

Installing the printer 43

Verifying the installation 47

3Overview

Multiplate technology 51

Components 51

Electronic pipette 54

Technical specification 58

Consumables and accessories 60

4 Software

Introduction 63

Main screen 65

Menu options 73

Operation

5 Operation

Safety 103

Starting the analyzer 105

Using the electronic pipette 106

Performing a measurement 108

Result handling 129

Deleting orders from the worklist 134

Reagent storage conditions and

preparation 135

Multiplate system control 138

Shutting down the analyzer 146

Taking the analyzer out of operation 146

Logging on as administrator (LabAdmin) 147

6 Configuration

Passwords 151

Setting up a printer 152

Adjusting the internal control parameters for

data alarms 153

Configuring the analyzer 154

Changing the language 159

Editing test parameters 160

LIS configuration 164

Electronic QC 165

Maintenance

7 Maintenance

Overview 171

Cleaning and disinfecting the analyzer 173

Maintenance and cleaning of the electronic

pipette 174

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

6 Table of contents

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

7

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:

Product name Descriptor

Multiplate

®

analyzer

Multiplate Transferpette electronic pipette or autopipette

y Descriptors

Symbol Comment

o List item

P Start of procedure

S End of procedure

U Cross-reference

f Navigation path indication

Q Tip

%1, %2 Placeholder for software provided

values.

Safety alert

Electrical and electronic equipment

marked with this symbol are covered by

the European directive WEEE.

y Symbols used for easy recognition of information

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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Symbols used on product

Abbreviations The following abbreviations are used:

Symbol Explanation

Date of manufacture

Global Trade Item Number.

y Symbols used on product

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

y Abbreviations used

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Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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What is new in publication version 4.0

Operating system Operating system changed to Windows 10

The operating system has been changed to Windows 10

for new Multiplate installations. The installation

instruction has been changed accordingly.

Layout Content migrated into new page layout.

Kiosk mode

The Multiplate

®

analyzer starts automatically in operator

mode without log on request.

Supported printer New Kyocera printer added.

u Installation of the printer (45)

New menu items The following menu items are directly available and

supported in the Multiplate software:

• Start IrfanView

u See:

Using keyboard shortcuts (63)

Start IrfanView (91)

To generate printouts using IrfanView p (120)

• Start PDF Reader

u See:

Using keyboard shortcuts (63)

PDF Reader (91)

• Logoff

u See:

Using keyboard shortcuts (63)

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Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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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 (18)

u Barcode read errors (24)

u Patient misidentification (24)

u Sharps, rough edges, and/or moving parts (21)

u Malicious software and hacker attacks (27)

u Unauthorized access (28)

u Data security (30)

u Data alarms (142)

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 (43)

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

u Barcodes (59)

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 (94)

LIS support and Worklist window LIS support was added. Use the new Worklist window to

do the following:

• Download orders from the LIS.

• Assign orders to channels.

• Start autopipette measurements.

• Upload results to the LIS.

• Manage orders.

u Worklist (79)

u Performing measurements using the worklist (108)

u Sending results to LIS from measurements created on

the analyzer (127)

u Deleting orders from the worklist (134)

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Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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The LIS communication is configured in the LIS

configuration window.

u LIS configuration (164)

Electronic QC Information about the Electronic QC window was added.

u Electronic QC (97)

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 (128)

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

u Deleting result data (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.

u Passwords (151)

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

u Test ID (161)

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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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.

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

System description

1 Safety .......................................................................................................................... 15

2 Installation................................................................................................................. 33

3 Overview .................................................................................................................... 49

4 Software..................................................................................................................... 61

1 Safety

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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Table of contents

Safety 1

In this chapter you find information about the safe

operation of the equipment.

In this chapter

1

Safety classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Operator qualification . . . . . . . . . . . . . . . . . . . . . . . 18

Safe and proper use of the analyzer . . . . . . . . . . . 18

Miscellaneous safety precautions . . . . . . . . . . . . . 19

Safety summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Sharps, rough edges, and/or moving parts. . . 21

Electrical safety . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Biohazardous materials . . . . . . . . . . . . . . . . . . . 22

Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Fire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Barcode read errors . . . . . . . . . . . . . . . . . . . . . . 24

Patient misidentification. . . . . . . . . . . . . . . . . . . 24

Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Reagents and other working solutions . . . . . . 25

Cross contamination of samples . . . . . . . . . . . 25

Fatigue due to long hours of operation . . . . . . 26

Malfunction due to interfering

electromagnetic fields . . . . . . . . . . . . . . . . . . . . 26

Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Malicious software and hacker attacks. . . . . . 27

Unauthorized access . . . . . . . . . . . . . . . . . . . . . 28

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Circuit breakers and fuses . . . . . . . . . . . . . . . . 29

Spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Data security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Safety labels on the equipment . . . . . . . . . . . . . . . . . . 31

1 Safety

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Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

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Table of contents

Disposal of the equipment . . . . . . . . . . . . . . . . . . . . . . 32

1 Safety

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

Safety classification 17

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.

1 Safety

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

18 Safety precautions

Safety precautions

!

Generic hazard statements

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

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.

• Do not carry out operation and maintenance unless

you have been trained by Roche Diagnostics.

• Carefully follow the procedures specified in the

Operator’s Manual for the operation and maintenance

of the analyzer.

• Leave maintenance, installation or service that is not

described in the Operator’s Manual to trained Roche

Service representatives.

• Follow standard laboratory practices, especially when

working with biohazardous material.

• 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

Personal protective equipment • 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.

• Wear a face shield if there is a chance of splash or

splatter.

1 Safety

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

Safety precautions 19

Accuracy/precision of measured results An incorrect measuring result may lead to an error in

diagnosis, therefore posing danger to the patient.

• Do not use consumables that have exceeded their

expiration date, otherwise inaccurate data may be

obtained.

• For diagnostic purposes always assess the results in

conjunction with the patient’s medical history, clinical

examination, and other findings.

Installation • Leave installation tasks that are not described in the

Operator’s Manual to trained Roche Service

representatives.

• Follow the installation instructions carefully.

Operating conditions • Operation outside of the specified ranges may lead to

incorrect results or malfunction of the analyzer.

u See Environmental conditions (58).

• Use the analyzer indoors only and avoid heat and

humidity.

u See Environmental conditions (58).

• Perform maintenance according to the specified

intervals to maintain the required operating conditions

for the analyzer.

• 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.

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.

u See Consumables and accessories (60).

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 (38).

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.

1 Safety

Roche Diagnostics

Multiplate® analyzer · Software version 2.06 · Operator’s Manual · version 4.0

20 Safety precautions

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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Roche Multiplate 5 Analyzer User manual

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