Leica THERMOBRITE ELITE Manual de usuario

THERMOBRITE®ELITE

MODEL NUMBER S600

USER MANUAL

A D V A N C E D S T A I N I N G I N S T R U M E N T S

Revision Record

Revision Issued Sections Affected Detail

A01 May 2020 - First release

B01 June 2020 Using the ThermoBrite Software Updated screen images to support FFPE.

B02 November

2021

Glossary of symbols on page 9

Software on page 44

Intended Use on page 7

2.12-Leica Biosystems Contact

Information

CE Mark on page 18

Important Information for All

Users on page 18

Disposition on page 85

The ThermoBrite Interface on

page 51

Network Requirements on page

Pause Step on page 78

Assign Waste Bottles on page

Module Manifold on page 40

Reagent Step on page 66

Flush on page 74

Removed Authorized Representative in the

European Community details.

Added Authorized Representative in the

European Community details to the Symbols

glossary.

Updated with new information to support

IVDR.

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1. Table of Contents

1. Table of Contents 3

2. Introduction 7

2.1 Intended Use 7

2.2 Trademarks 7

2.3 Copyright 7

2.4 How to use the User Manual 7

2.5 Notes, Precautions, and Warnings 8

2.5.1 Notes 8

2.5.2 Cautions 8

2.5.3 Warnings 8

2.5.4 Biological Warnings 8

2.6 Glossary of symbols 9

2.6.1 Regulatory symbols 9

2.6.1.1 ISO 15223-1 9

2.6.1.2 ISO 7000 10

2.6.1.3 IEC 60417 11

2.6.1.4 Other symbols and markings 12

2.6.2 Safety symbols 14

2.6.2.1 ISO 7010 14

2.7 Warnings, Precautions, Limitations 15

2.8 Instructions for In Vitro Diagnostic Equipment for Professional Use 15

2.9 FCC compliance 15

2.10 Classification of Equipment Under CISPR 11 (EN 55011) 16

2.11 Precautions and Safety 16

2.12 Leica Biosystems Contact Information 18

2.12.1 CE Mark 18

2.12.2 Manufacturer 18

2.12.3 Important Information for All Users 18

2.13 Warranty 19

2.13.1 Leica Biosystems Warranty 19

2.13.2 Limitation of Liability 19

2.13.3 Use of Third Party Computer Products 19

2.13.4 Use of External USB device to Netbook 20

3. Installation 21

3.1 Unpacking 21

3.2 Contents 22

3.2.1 ThermoBrite Elite System 22

3.2.2 Preventative Maintenance Kits 23

3.3 Requirements 24

3.3.1 Electrical Requirements 24

3.3.2 Temperature Requirements 24

3.3.3 Space Requirements 24

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1. Table of Contents

3.3.4 Environmental Requirements 24

3.3.5 Network Requirements 25

3.4 Installation 26

3.4.1 Fluid Management System 29

3.5 End User License Agreement 34

4. System Description 37

4.1 Theory of Operation 37

4.2 Components 37

4.2.1 Front 37

4.2.2 Back 38

4.2.3 Fluidic System 39

4.2.3.1 Reagent Manifold 39

4.2.3.2 Waste Manifold 39

4.2.3.3 Pumps 40

4.2.4 Slide Carriers 41

4.2.4.1 Sample Chambers 42

4.2.5 Electrical and Communication Connections 43

4.2.5.1 Power Port and Power Switch 43

4.2.5.2 Netbook Communication Port 43

4.2.6 Software 44

5. Preparing the System for Run 45

5.1 Reagents 45

5.1.1 Compatible Reagents 45

5.1.2 Reagent Preparation and Connection 46

5.2 Slide Preparation 49

5.3 System Ready 49

6. Using the ThermoBrite Elite Software 51

6.1 Before operating the instrument 51

6.2 The ThermoBrite Interface 51

6.3 Running a Protocol 52

6.3.1 Before running a protocol 52

6.3.2 Select a Protocol to Run 53

6.3.3 Add Slides to Module 54

6.3.4 Start the Protocol 56

6.3.5 Monitor the Protocol Run Status 58

6.3.5.1 Slide Position 58

6.3.5.2 Current Module Temperature 58

6.3.6 Review the Protocol Completion Summary 60

6.3.6.1 View Summary Log 61

6.3.6.2 View Detail Log 61

6.3.6.3 Drain Chambers 62

6.3.6.4 Save and Run Line Wash 62

6.3.6.5 Save Notes and Close 62

6.3.7 After running a protocol 62

6.4 Creating a New Protocol 63

6.4.1 Add Protocol Steps 66

6.4.1.1 Reagent Step 66

6.4.1.2 Prime Step 77

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1. Table of Contents

6.4.1.3 Pause Step 78

6.4.1.4 Drain Step 79

6.4.2 Assign Waste Bottles 79

6.4.3 Check Alerts 81

6.4.3.1 Warning Protocol Issues 81

6.4.3.2 Warning Invalid Protocol Name 81

7. Maintenance 83

7.1 Cleaning and maintenance checklist 84

7.2 Disposition 85

7.2.1 Discarding Liquid Waste 85

7.2.2 Discarding Instrument Parts 85

7.3 Line Wash 85

7.3.1 Run a line wash 86

7.4 Cleaning 89

7.4.1 After each run 89

7.4.1.1 Clean Sample Chambers 89

7.4.1.2 Clean the Upper Drip Plate 89

7.4.1.3 Clean the Pepsin Bottle 90

7.4.1.4 Clean the Pepsin Line 90

7.4.2 Monthly 90

7.4.2.1 Clean Instrument Surfaces 90

7.4.2.2 Clean Slide Carriers 90

7.4.2.3 Clean Reagent Bottles and Filters 91

7.4.2.4 Clean Waste Bottles 91

7.4.2.5 Clean the Netbook 91

7.5 Back up Data 92

7.5.1 Back up Log Files on Netbook 92

7.5.2 Back up Protocol Files on Netbook 92

7.6 As Needed Maintenance 93

7.6.1 Replace the Module Manifold Filters 93

7.6.2 Replace the Peristaltic Pump Tubes 94

7.6.3 Replace the Fuses 97

8. Troubleshooting 99

8.1 Troubleshooting by Symptoms 99

8.2 Error Messages 102

8.2.1 Cannot load protocol 102

8.2.2 Could not switch the # to # 102

8.2.3 Drain Side Low Flow 102

8.2.4 Error loading Protocol 102

8.2.5 Exit valve failed to switch to bypass position 103

8.2.6 Inlet valve failed to switch to bypass position 103

8.2.7 Inlet valve failed to switch to chamber 103

8.2.8 Instrument failed self-test 103

8.2.9 Instrument thread is either terminated or unresponsive within 20sec. Software

will terminate 103

8.2.10 Modules did not reach target temperature(s) within 1 hour 104

8.2.11 Internal software error 104

8.2.12 Internal instrument error 104

8.2.13 Internal operation error 104

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8.2.14 Internal runner module error 104

8.2.15 No ThermoBrite Elite found 105

8.2.16 Reagent valve failed to switch to reagent line # 105

8.2.17 Self-test failed to communicate with Instrument 105

8.2.18 Sensors indicate a critical flow error 106

8.2.19 Sensors indicate reduced flow rate warning(s) 106

8.2.20 The protocol has failed 107

8.2.21 This protocol contains errors and it cannot be run 107

8.2.22 Unhandled exception 107

8.2.23 USB Communication interruption 107

8.3 Checking USB Connections 108

9. Specifications 109

9.1 References 110

Index 111

6 ThermoBrite Elite User Manual

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1. Table of Contents

ThermoBrite Elite User Manual

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2. Introduction

2.1 Intended Use

For in-vitro diagnostic use only.

ThermoBrite Elite automates protocols for FISH testing of pathology specimens mounted on microscope slides.

ThermoBrite Elite fully automates pre and post hybridization steps while providing temperature control for on-board

denaturation and hybridization. Microscope slides subsequently undergo interpretation by a qualified healthcare

professional to aid diagnosis.

2.2 Trademarks

Leica and the Leica logo are registered trademarks of Leica Microsystems IR GmbH and used under license. ThermoBrite

is a trademark of Leica Biosystems. Other trademarks are the property of their owners.

2.3 Copyright

Leica Biosystems Melbourne Pty Ltd owns the copyright on this document and any associated software. Under law, our

written permission is required before either the documentation or the software is copied, reproduced, translated, or

converted to electronic or other machine-readable form, in whole or in part.

Doc. 3855-7500-501 Rev. B02

2.4 How to use the User Manual

This document is the User Manual for the ThermoBrite Elite System. Read this manual carefully before operating the

instrument, since the manual contains instructions for safe installation, operation, maintenance, and troubleshooting. A

thorough knowledge of the system is recommended before any installation or use of the system.

System operations are explained in detail, and as such, the manual may be used for user training. The system operations

detailed in the manual include Theory of Operation, System Component review, sample and reagent preparation, and

protocol development using the ThermoBrite Elite System.

Please retain this manual for future use.

2.5 Notes, Precautions, and Warnings

The User Manual includes information and warnings that must be observed by the user in order to ensure safe operation

of the system. Important messages are highlighted with borders and special icons identifying the type of message

enclosed.

There are four types of messages: Notes, Cautions, Warnings, and Biological Warnings. These are explained below:

2.5.1 Notes

Highlights important facts, gives helpful information and tips, and clarifies procedures.

2.5.2 Cautions

Electrical hazard! Unplug before handling.

Important information on the proper operation of the ThermoBrite Elite System. This information is crucial

for preventing instrument damage and maintaining the system.

2.5.3 Warnings

Identifies potentially hazardous situations that could result in serious injury to laboratory personnel.

2.5.4 Biological Warnings

Use care when handling specimens. Always use personal protective equipment to prevent exposure to

pathogens; i.e., bloody specimens. Incorrect or imprecise procedures may result in exposure to pathogens.

This unit must be used only by users trained in proper procedures for clinical testing and handling of

biohazardous waste.

2. Introduction

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2.6 Glossary of symbols

2.6.1 Regulatory symbols

Explanation of the regulatory symbols used for Leica Biosystems products.

Note: This glossary provides images of the symbols as presented in the relevant standards, however,

some of the symbols may vary in color.

The following is a list of symbols used on the product labeling and their meaning.

2.6.1.1 ISO 15223-1

Medical devices – symbols to be used with medical device labels, labeling and information to be supplied – Part 1:

General requirements.

Symbol Standard/

Regulation

Reference Description

ISO 15223-1 5.1.1 Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1 5.1.2 Authorized representative in the European community

Indicates the Authorized representative in the European

Community.

ISO 15223-1 5.1.3 Date of manufacture

Indicates the date when the medical device was manufactured.

ISO 15223-1 5.1.4 Use by (expiration date)

Indicates the date after which the medical device is not to be

used.

ISO 15223-1 5.1.5 Batch code

Indicates the manufacturer's batch code so that the batch or lot

can be identified.

ISO 15223-1 5.1.6 Catalog number / Reference number

Indicates the manufacturer's catalog number so that the medical

device can be identified.

ISO 15223-1 5.1.7 Serial number

Indicates the manufacturer's serial number so that a specific

medical device can be identified.

ISO 15223-1 5.3.1 Fragile; handle with care

Indicates a medical device that can be broken or damaged if not

handled carefully.

2. Introduction

ThermoBrite Elite User Manual

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Symbol Standard/

Regulation

Reference Description

ISO 15223-1 5.3.4 Keep away from rain

Indicates that the transport package shall be kept away from

rain and in dry conditions.

ISO 15223-1 5.3.7 Temperature limit

Indicates the temperature limits to which the medical device can

be safely exposed.

ISO 15223-1 5.4.2 Do not re-use

Indicates a medical device that is intended for one use, or for

use on a single patient during a single procedure.

ISO 15223-1 5.4.3 Consult instructions for use

Indicates the need for the user to consult the instructions for

use.

ISO 15223-1 5.4.4 Caution

Indicates the need for the user to consult the instructions for use

for important cautionary information such as warnings and

precautions that cannot, for a variety of reasons, be presented

on the medical device itself.

ISO 15223-1 5.5.1 In Vitro Diagnostic medical device

Indicates a medical device that is intended to be used as an in

vitro diagnostic medical device.

ISO 15223-1 5.1.8 Importer

Indicates the entity importing the medical device into the

European Union.

2.6.1.2 ISO 7000

Graphical symbols for use on equipment — Registered symbols.

Symbol Standard/

Regulation

Reference Description

ISO 7000 1135 Recycle

Indicates that the marked item or its material is part of a

recovery or recycling process.

ISO 7000 1640 Technical manual; manual for service

Identifies the location where the handbook is stored or to

identify information that relates to the servicing instructions for

the equipment. To indicate that the service manual or handbook

should be considered when servicing the device close to where

the symbol is placed.

2. Introduction

10 ThermoBrite Elite User Manual

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