Roche VENTANA HE 600 User manual

VENTANA HE 600 System

User Guide

101496700EN Version G

Software version 1.9.4

Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

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Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

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Publication information

Edition notice This publication is intended for operators of the

VENTANA HE 600 system.

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 User Guide contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• Configuration information

In addition, the User Assistance includes videos and a

hardware explorer.

Publication

version

Software version Revision date Change description

B September 2015 First manual

C May 2016 The following updates were made:

o Updated software version

o Updated protocol selection

o Updated Maintenance and Troubleshooting chapter

o Updated warranty

o Added operator language to footers

D December 2016 The following updates were made:

o Updated Intended User Statement

o Added System Setting Sleep

o Added System Setting Alerts

o Updated Maintenance and Troubleshooting chapter

E January 2017 Updated coverslip cassette logic description

F 1.9.2 December 2017 Updated document format, and added updates for software

version 1.9.2

G 1.9.4 September 2018 Added updates for software version 1.9.4 and associated

hardware updates.

y Revision history

Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

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!

General attention

To avoid serious or fatal personal injury, ensure that you

are familiar with the system and safety information before

you use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

described in this publication.

!

General attention

To avoid incorrect results, ensure that you are familiar

with the instructions and safety information.

r Pay particular attention to all safety notices.

r Always follow the instructions in this publication.

r Do not use the software in a way that is not described

in this publication.

Training Do not carry out operation tasks or maintenance actions

unless you have received training. Leave tasks that are

not described in the user documentation to trained Roche

Service representatives.

Images The screen shots and hardware images in this publication

have been added exclusively for illustration purposes.

Configurable and variable data in screen shots, 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.

License information System software is protected by contract law, copyright

law, and international treaties. The system contains a user

license and only authorized users may access the

software and use it. Unauthorized use and distribution

may result in civil and criminal penalties.

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VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

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Open Source and Commercial Software VENTANA HE 600 system software may include

components or modules of commercial or open-source

software.

This open source and commercial software and

VENTANA HE 600 system software as a whole can

constitute a device regulated in accordance with

applicable law. For more detailed information, refer to the

user manual and labeling.

Please note that the respective authorization is no longer

valid according to the corresponding legislation should

any unauthorized changes be made to the VENTANA HE

600 system software. For further information on the

intellectual property and other warnings, as well as

licenses pertaining to the software programs included in

VENTANA HE 600 system software, refer to the Appendix.

u Open Source License Notifications and Notices (193)

Trademarks The following trademarks are acknowledged:

VENTANA, CareGiver, VANTAGE, VENTANA HE, and the

VENTANA logo are trademarks of Roche.

All other trademarks are the property of their respective

owners.

Feedback Every effort has been made to ensure that this publication

fulfills the intended use. All feedback on any aspect of

this publication is welcome and is considered during

updates. Contact your Roche representative, should you

have any such feedback.

Approvals The VENTANA HE 600 system is manufactured and

compliant to the following applicable international

standards:

EN 61010-1 Safety requirements for electrical equipment

for measurement, control, and laboratory use – Part 1:

General requirements.

IEC 61010-2-010 Safety requirements for electrical

equipment for measurement, control, and laboratory use,

Part 2-010: Particular requirements for laboratory

equipment for the heating of materials.

IEC 61010-2-081 Safety requirements for electrical

equipment for measurement, control, and laboratory use

– Part 2-081: Particular requirements for automatic and

semi-automatic laboratory equipment for analysis and

other purposes.

Roche Diagnostics

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EN 61010-2-101 Safety requirements for electrical

equipment for measurement, control, and laboratory use

– Part 2-101: Particular requirements for in vitro

diagnostic (IVD) medical equipment.

EN 61326-1 Electrical equipment for measurement,

control and laboratory use—EMC requirements - Part 1:

General requirements.

EN 61326-2-6 Electrical equipment for measurement,

control, and laboratory use - EMC requirements – Part 2-

6: Particular requirements - in vitro diagnostic (IVD)

medical equipment.

EN ISO 18113-1:2011 In vitro diagnostics medical devices

- Information supplied by the manufacturer (labeling) -

Part I: Terms, definitions, and general requirements.

EN ISO 18113-1:2011 In vitro diagnostics medical devices

- Information supplied by the manufacturer (labeling) -

Part II: In vitro diagnostic reagent for professional use.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the European Union Directive 98/79/EC.

Issued by Canadian Standards Association (CSA) Group

for Canada and the US.

CUS

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FCC information This equipment generates, uses, and can radiate radio

frequency energy; if not installed and used in accordance

with the operator manual, it may cause interference to

radio communications. Operation of this equipment in a

residential area is likely to cause interference, in which

case users will be required to correct the interference at

their own expense. There is no guarantee that

interference will not occur in a particular installation.

If this equipment does cause interference to radio or

television reception, which can be determined by turning

the equipment off and on, the user is encouraged to try to

correct the interference by one or more of the following

measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and

receiver.

• Connect the equipment to an outlet on a different

circuit from the one the receiver is connected to.

• Consult the dealer or an experienced radio/TV

technician for help.

Changes or modifications not expressly approved by the

party responsible for compliance with Part 15 of the

Federal Communication Commission (FCC) rules could

void the user’s authority to operate the equipment.

Canadian DOC Information This digital apparatus does not exceed the Class A limits

for radio noise emissions from digital apparatuses as set

out in the Radio Frequency Regulations of the

Department of Communications (DOC).

Contact addresses

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive

Tucson, Arizona 85755

USA

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Roche Diagnostics

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Table of contents 9

Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

Table of contents

Publication information 3

Contact addresses 7

Table of contents 9

Intended use 11

Symbols and abbreviations 11

What is new in publication version G 13

Safety

1Safety

Introduction 19

Safety classifications 20

Safety training 21

Safety precautions 22

Warning messages 25

Caution messages 27

Notices 31

Safety labels on the system 33

Safety information for disposal 39

System Description

2 System overview

Staining process workflow 45

System overview 46

User interface overview 53

3 Specifications

List of system specifications 65

Supported material 68

Operation

5 System operation

Slide processing quick start guide 77

Preparing to process slides 78

Processing a slide tray 85

Managing reagents and consumables 105

Managing waste containers 123

Generating reports 128

6 Configuration

Creating and modifying staining protocols 133

Changing system settings 138

7Maintenance

System maintenance 149

Preparing the system for non-use 152

8 Errors and troubleshooting

Viewing and filtering the error log 155

List of error messages 157

Troubleshooting tray recovery 172

Troubleshooting coverslip issues 184

Error recovery procedures 187

Appendix

9 Open Source License Notifications and Notices

Open source license notifications and

notices 195

The MIT License (MIT) Simple MVVM

Toolkit 196

Mozilla Public License Version 2.0 197

Apache License, Version 2.0, January 2004 205

GNU General Public License 210

10 Table of contents

Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

Roche Diagnostics

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Intended use

VENTANA HE 600 system is a platform consisting of

instrument, software, and reagents, used for hematoxylin

and eosin staining of histologic sections from formalin-

fixed, paraffin-embedded tissues. The product’s intended

use environment includes anatomic pathology (AP)

laboratories and histology facilities located within

hospital, clinic, reference, or private lab settings. The

product is to be operated by qualified users in the AP

laboratory who are trained on VENTANA HE 600 system.

Symbols and abbreviations

Product names The following product names and descriptors are used in

this publication.

Symbols used in the publication

Product name Descriptor

VENTANA HE 600 system

VENTANA HE 600 user interface

VENTANA HE 600 system software

VENTANA HE 600 Wash

VENTANA HE 600 Hematoxylin

VENTANA HE 600 Bluing

VENTANA HE 600 Eosin

VENTANA HE 600 Organic Solution

VENTANA HE 600 Differentiating Solution

VENTANA HE 600 Transfer Fluid

VENTANA HE 600 Cleaning Solution

VENTANA HE 600 Cleaning Agent

VENTANA HE 600 Coverslip Activator

y Product names

Symbol Explanation

o List item.

u Related topics containing further information.

q

Tip. Extra information on correct use or useful

hints.

r Start of a task.

I Extra information within a task.

f Result of an action within a task.

c Frequency of a task.

n Duration of a task.

d Materials that are required for a task.

y Symbols used in the publication

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Abbreviations The following abbreviations are used.

j Prerequisites of a task.

u Topic. Used in cross-references to topics.

p Task. Used in cross-references to tasks.

w

Figure. Used in figure titles and cross-

references to figures.

y

Table. Used in table titles and cross-references

to tables.

z

Equation. Used in cross-references to

equations.

k

Code example. Used in code titles and cross-

references to codes.

Symbol Explanation

y Symbols used in the publication

Abbreviation Definition

AFM Automated fluidics module

ANSI American National Standards Institute

AP Anatomic pathology

CSA Canadian Standards Association

CSC Customer support center

CSV Comma-separated values

DOC Department of Communications

dPGPE Dipropylene glycol propyl ether

EC European Community

EN European standard

FCC Federal Communications Commission

H&E Hematoxlyin and eosin

IEC International Electrical Commission

IHC Immunohistochemistry

ISH In situ hybridization

ISO International Organization for

Standardization

IT Information technology

IVD In vitro diagnostic

LIS Laboratory information system

PDF Portable document format

PHI Personal healthcare information

PPE Personal protective equipment

QR code Quick response code

RFID Radio-frequency identification

RJ45 Registered jack 45

SDS Safety data sheets

TCP/IP Transmission control protocol/internet

protocol

UPS Uninterruptible power supply

USB Universal serial bus

y Abbreviations

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What is new in publication version G

New topics This lists the topics that were added or updated for the

VENTANA HE 600 System User Guide Revision G.

u Slide tray handling guidelines (82)

u Using the H&E Coverslip Recovery protocol (91)

u Stopping and shutting down the system (100)

u Creating a new staining protocol (133)

u Modifying a staining protocol (135)

u Viewing and filtering the error log (155)

u List of error messages (157)

u Turning off the system (173)

u Recovering a tray from the garage (183)

u Restarting the user interface if software

unresponsive (187)

u Disabling a stainer module (189)

User Assistance The VENTANA HE 600 system user documentation is

available in portable document format (PDF) as well as an

interactive help system (User Assistance). The User

Assistance contains unique features, which include the

following:

• Hardware explorer

•Videos

• Tray recovery troubleshooter

Roche Diagnostics

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Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

Safety

1 Safety .......................................................................................................................... 17

1 Safety

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Table of contents

Safety 1

In this chapter

1

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Safety training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

About operator qualification . . . . . . . . . . . . . . . . . . 22

About safe and proper use of the system . . . . . . . 22

Miscellaneous safety precautions overview . . . . . 24

Warning messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Electrical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Instrument location . . . . . . . . . . . . . . . . . . . . . . . . . 26

Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Burns due to hot surfaces . . . . . . . . . . . . . . . . . . . . 27

Mechanical safety . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Reagents and other working solutions . . . . . . . . . 28

Electromagnetic interference . . . . . . . . . . . . . . . . . 30

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

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Safety labels on the system. . . . . . . . . . . . . . . . . . . . . . 33

List of safety labels on the system . . . . . . . . . . . . . 33

Location of safety labels on the system . . . . . . . . 34

Safety information for disposal. . . . . . . . . . . . . . . . . . . 39

Disposal information . . . . . . . . . . . . . . . . . . . . . . . . 39

1 Safety

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Table of contents

1 Safety

Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

Safety 19

Introduction

!

General attention

To avoid serious or fatal personal injury, read this

publication thoroughly before you use the instrument.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not

described in this publication.

All safety-related regulations, local codes, and

instructions that appear in this document or on

equipment must be observed. To ensure personal safety

and to prevent damage to the instrument or equipment

connected to it, observe the safety information. If

equipment is used in a manner not specified by the

manufacturer, the protection provided by the equipment

could be impaired.

1 Safety

Roche Diagnostics

VENTANA HE 600 System · Software version 1.9.4 · User Guide · 101496700EN Version G

20 Safety classifications

Safety classifications

The safety precautions and important user notes are

classified according to the ANSI Z535.6-2011 standard.

Familiarize yourself with the following meanings and

icons:

!

Safety alert

r The safety alert symbol is used to alert you to potential

physical injury hazards. Obey all safety messages that

follow this symbol to avoid possible damage to the

system, personal injury, or death.

These symbols and signal words are used for specific

hazards:

WARNING

!

Warning...

r ...indicates a hazardous situation that, if not avoided,

could result in death or serious personal injury.

CAUTION

!

Caution...

r ...indicates a hazardous situation that, if not avoided,

could result in minor or moderate personal injury.

NOTICE

Notice...

r ...indicates a hazardous situation that, if not avoided,

may result in damage to the system.

Important information that is not safety relevant is

indicated with the following icon:

q Tip...

...indicates additional information on correct use or useful

tips.

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Roche VENTANA HE 600 User manual

Roche VENTANA HE 600 User manual

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