Leica BOND-PRIME Manuel utilisateur

BOND-PRIME

FULLY AUTOMATED IHC AND ISH STAINING SYSTEM

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

(NOT for use in China)

BOND-PRIME User Manual, 91.7500.501 A07

Table of contents

Table of contents 2

1 BOND-PRIME hardware 25

1.1 About the BOND System 26

1.1.1 BOND System ancillary materials and consumable items 27

1.2 The BOND-PRIME Processing Module 29

1.2.1 Front view 29

1.2.2 Rear view 30

1.3 The Hood 31

1.4 Preload and Unload Drawers 32

1.5 Slide Drawer Inserts, Waste Drains and Sumps, and Pickup Filter 33

1.5.1 Slide Drawer Inserts 33

1.5.2 Waste Drains 34

1.5.3 Sumps and Pickup Tube with Filter 35

1.6 Reagent Platform 36

1.7 Bulk Containers 37

1.8 Reservoir Cabinet 39

1.9 AC power switch 40

1.10 Reagent Trays 41

1.11 The Work Surface (under the Hood) 42

1.12 Work Surface (front view) 43

1.12.1 High-Speed Robot 44

1.12.2 Probe Selector 45

1.12.3 Wash Robots 46

1.12.4 ARC (Active Reagent Control) Modules 47

1.12.5 Wash/Prime Stations 49

1.12.6 Mixing Well Plate 50

1.12.7 Slide Preparation Station 51

1.13 Connect the processing module and switch on 52

1.14 Disconnect the processing module 54

1.15 Move a processing module to a new location 56

1.16 Decommission and dispose of a processing module 58

Table of contents

BOND-PRIME User Manual, 91.7500.501 A07

2 Touchscreen 59

2.1 Log in and log out 60

2.1.1 Log in 60

2.1.2 Log out 61

2.2 Navigation Bar 62

2.3 Status Screen 63

2.3.1 Slides Loaded Segment 63

2.3.2 Slides Processing Segment 65

2.3.3 Slides Processing Complete Segment 67

2.3.4 View more slide information 68

2.3.5 Unexpected events during processing 69

2.4 Action Queue and Alert Banner 71

2.4.1 Show and hide the Action Queue 71

2.4.2 Complete a task suggested in an Action Queue Item 72

2.4.3 Manually hide the Alert Banner 73

2.5 Preload slides 74

2.6 Preload Screen 76

2.6.1 Preload Drawer view 77

2.6.2 Preload Case view 79

2.7 Unload slides 81

2.8 Unload Screen 83

2.8.1 Unload Drawer view 84

2.8.2 Unload case view 85

2.9 Detailed case and slide information 87

2.9.1 View each slide in a case 89

2.9.2 Stop a slide in progress 90

2.10 Reagents Screen 91

2.10.1 Prepare Reagent Container and Reagent Trays 91

2.10.2 Load Reagent Trays 93

2.10.3 Examples of reagent system icons 94

2.10.4 Examples of Reagent Container icons 94

2.10.5 View reagent system and Reagent Container details 95

2.10.6 Unload Reagent Trays 97

Table of contents

BOND-PRIME User Manual, 91.7500.501 A07

2.11 Maintenance Screen 98

3 Quick start 99

3.1 Introduction 100

3.2 Start the processing module 101

3.3 Load the Reagent Tray and DS9824 Detection System 103

3.4 Preload, process, and unload the slides 105

4 Cleaning and maintenance 109

4.1 Maintenance schedules 110

4.1.1 Preventative service reminder 110

4.1.2 Cleaning and maintenance schedule 110

4.1.3 Cleaning and maintenance checklist 112

4.2 Refill the DI Water Container 113

4.3 Refill the Alcohol Container 115

4.4 Refill the Lot Tracked Bulk Containers 118

4.5 Empty the Waste Containers 121

4.6 Use the BOND-PRIME Cleaning Kit 123

4.7 Start Maintenance 127

4.8 Wipe internal surface of ARC Modules 129

4.9 Wipe down Reagent Platform and ARC Bank Surfaces 133

4.10 Clean the Suction Cup 137

4.11 Replace the Suction Cup 141

4.12 Clean the Slide Drawer Inserts, Waste Drains and Sumps, and Pickup Filter 145

Clean the Slide Drawer Inserts 145

Clean the Waste Drains and Sump 149

Clean the Pickup Tube and Filter 150

4.13 Clean the Wash/Prime Stations 154

4.14 Use the BOND-PRIME ARC Refresh Kit 158

4.15 Clean the Bulk DI Water Container 163

4.16 Clean the Locked Bulk Reagent Containers 166

4.17 Clean the Waste Containers 176

4.18 Clean the Sump Tray 179

4.19 Stop maintenance 181

4.20 Shutdown the processing module 183

Table of contents

BOND-PRIME User Manual, 91.7500.501 A07

4.21 Replace power supply fuses 185

5 Troubleshooting 188

5.1 Failure to initialize 189

5.2 Network connectivity error 189

5.3 Manually retrieve slides from the processing module 190

5.3.1 Manually retrieve slides from Preload and Unload Drawers 190

5.3.2 Manually retrieve slides from the Work Surface 191

5.3.3 Manually retrieve slides from ARC Modules 193

5.3.4 Manually retrieve slides from ARC Modules during a power failure 196

5.4 Remove a slide fragment from an ARC Module 198

6 Specifications 200

6.1 System specifications 201

6.2 Physical specifications 201

6.3 Electrical power and UPS requirements 201

6.4 Environmental specifications 202

6.5 Operating specifications 202

6.6 Microscope slide specifications 203

6.7 Transport and storage specifications 204

Index 205

BOND-PRIME User Manual, 91.7500.501 A07

Legal notices

Trademarks

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

System, BOND-III, BOND-MAX, BOND-PRIME, BOND-ADVANCE, Covertile, Bond Polymer Refine Detection, Bond

Polymer Refine Red Detection, Parallel Automation, Compact Polymer, and Oracle are trademarks of Leica

Biosystems Melbourne Pty Ltd ACN 008 582 401. Other trademarks are the property of their owners.

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.

Product identification

Doc. 91.7500.501 A07

Manufacturer

Leica Biosystems Melbourne Pty Ltd

495 Blackburn Road

Mount Waverley VIC 3149

Australia

Important information for all users

This manual contains important information on how to use BOND-PRIME. For the latest information on Leica

Biosystems products and services, please visit www.leicabiosystems.com.

Due to a policy of continuous improvement, Leica Biosystems reserves the right to change specifications without

notice.

BOND-PRIME User Manual, 91.7500.501 A07

Terminology

The following terms are used in this document:

lLeica Biosystems—refers to Leica Biosystems Melbourne Pty Ltd.

lBOND System - the Leica Biosystems platform that includes the BOND-III, BOND-MAX, and BOND-PRIME

lBOND-PRIME - a type of automated IHC and ISH staining instrument

lBOND System software - the software application through which users can configure and operate the BOND-

III, BOND-MAX, or BOND-PRIME system

Intended users

The intended users of BOND-PRIME are adequately trained laboratory personnel.

Persons operating a BOND Processing Module must have received sufficient training to ensure that it is used in

accordance with this document and be fully aware of any potential hazards or hazardous procedures, before

operating the processing module. Only trained staff are to remove any covers or parts from the processing module,

and only if instructed within this manual.

Installation and repairs

Installation and repairs must only be carried out by qualified service personnel authorized by Leica Biosystems.

Warranty claims can be made only if the product has been used for the specified application and operated according

to the instructions in this document. Damage resulting from inappropriate handling and/or misuse of the product will

invalidate the warranty. Leica Biosystems cannot assume liability for any such damage.

Serious incident reporting

The occurrence of any serious incident(s) that either has led to, or may lead to, death of a patient or user, or the

temporary or permanent deterioration in the state of health of a patient or user must be reported to a local Leica

Biosystems representative and the relevant local Regulatory Authority.

Statement for User Data Security and Privacy

Leica Biosystems respects, and is committed to protecting, personal data security and privacy. The Leica Biosystems

Privacy Notice below describes the personal data that we may collect, use and retain.

Privacy Notice

The licensee shall comply with all applicable data protection and privacy laws in processing personal data using the

BOND, without limitation, by making all required notifications to, and obtaining all required consents from, patients

and other data subjects prior to processing their personal data.

BOND-PRIME User Manual, 91.7500.501 A07

The following types of Personal Data exist on the BOND Processing Module:

lPatient Name — is held temporarily on the BOND for tracking the run details of the slide whilst the slide is

processed.

lDoctor Name — is held temporarily on the BOND for tracking the run details of the slide whilst the slide is

processed.

lSlide ID — is held temporarily on the BOND for tracking the run details of the slide whilst the slide is processed.

lUser account details — User account details are encrypted in the data files and retained in the BOND System

Controller until deleted by a Supervisor. No user data is stored on the BOND Processing Module.

lSlide Images — Images of processed slides are collected for tracking the run details of the slide. Slide images

are encrypted in the data files and retained on the BOND System Controller indefinitely. The images are

automatically removed from the BOND Processing Module after one day.

Contacting Leica Biosystems

For service or support contact your local Leica Biosystems representative or see www.leicabiosystems.com.

BOND-PRIME User Manual, 91.7500.501 A07

Revision record

Rev Issued Sections affected Detail

A07 January

2023

All

4.14Use the BOND-PRIME ARC Refresh Kit

6Specifications

5Troubleshooting

Legal notices

Changed layout of the manual.

Added slide count equivalency table.

Enhanced slide specifications image.

Added Service life and cybersecurity

certificate life.

Added Troubleshooting chapter.

Added Statement of Intended Use of Personal

Data.

A06 July 2022 2.10.4Examples of Reagent Container

icons

4.14Use the BOND-PRIME ARC Refresh Kit

4.1Maintenance schedules

Removed obsolete reagent container icons.

ARC Refresh kit maintenance period changed

to 4 months.

A05 April 2022 1.8Reservoir Cabinet

1.9AC power switch

1.4Preload and Unload Drawers

2.5Preload slides

2.6Preload Screen

2.7Unload slides

2.8Unload Screen

3.4Preload, process, and unload the slides

4.12Clean the Slide Drawer Inserts, Waste

Drains and Sumps, and Pickup Filter

4.14Use the BOND-PRIME ARC Refresh Kit

4.16Clean the Locked Bulk Reagent

Containers

1.12.3Wash Robots

5.3.3Manually retrieve slides from ARC

Modules

1BOND-PRIME hardware

4.21Replace power supply fuses

1.2The BOND-PRIME Processing Module

Updated images of Reservoir Cabinet.

Updated images of Preload and Unload

Drawers.

Updated image to remove and install

Covertile.

Added information about refilling the

containers.

Added notes about being able to manually

move Wash Robots.

Removed part numbers.

A04 January

2022

5.3Manually retrieve slides from the

processing module

Glossary of symbols

All

Added instructions for removing slides from

the processing module.

Updated Glossary of Symbols.

Updated Intended Use statement.

Various corrections and updates to reflect

the latest touchscreen interface and to

improve the usability of the manual.

Removed Clean the Slide Preparation

section.

BOND-PRIME User Manual, 91.7500.501 A07

Rev Issued Sections affected Detail

A03 June 2021 Front cover

General cautions

1.1About the BOND System

1.2The BOND-PRIME Processing Module

1.7Bulk Containers

1.11The Work Surface (under the Hood)

1.12.5Wash/Prime Stations

1.12.7Slide Preparation Station

2.3Status Screen

2.3.1.1Slides not accepted

2.3.5Unexpected events during processing

2.4Action Queue and Alert Banner

2.5Preload slides

3Quick start

3.2Start the processing module

4.1Maintenance schedules

4.2Refill the DI Water Container

4.4Refill the Lot Tracked Bulk Containers

4.5Empty the Waste Containers

4.6Use the BOND-PRIME Cleaning Kit

4.8Wipe internal surface of ARC Modules

4.14Use the BOND-PRIME ARC Refresh Kit

4.11Replace the Suction Cup

4.13Clean the Wash/Prime Stations

4.12Clean the Slide Drawer Inserts, Waste

Drains and Sumps, and Pickup Filter

4.15Clean the Bulk DI Water Container

4.16Clean the Locked Bulk Reagent

Containers

4.17Clean the Waste Containers

4.18Clean the Sump Tray

6Specifications

Rebranding.

Various corrections, updates and additions

etc. in all listed sections affected.

A02 April 2021 All First release.

A01 - - Not released.

Ce manuel convient aux modèles suivants

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