Roche DISCOVERY ULTRA User manual

VENTANA DISCOVERY ULTRA

Instrument

(Research Use Only)

User Guide

D135664 Version 1

Software Version 12.5

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

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Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

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Publication information

Edition notice This publication is intended for operators of the

DISCOVERY ULTRA 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

!

General attention

To avoid serious or fatal 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.

r Store all publications in a safe and easily retrievable

place.

!

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.

r Store all publications in a safe and easily retrievable

place.

Publication

version

Software version Revision date Change description

1 12.5 - 12.5.2 August 2018 First version. Documentation to cover software version 12.5

through 12.5.2.

y Revision history

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

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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 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.

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.

Trademarks The following trademarks are acknowledged:

VENTANA, DISCOVERY, BENCHMARK, VANTAGE, and

the VENTANA logo are trademarks of Roche.

Other product names and 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, if you have

any such feedback.

Approvals The DISCOVERY ULTRA instrument meets the

requirements laid down in:

IEC/EN 61010-1 Safety requirements for electrical

equipment for measurement, control, and laboratory use.

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.

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

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EN 61010-2-101 Safety requirements for electrical

equipment for measurement, control, and laboratory use.

EN 61326-2-6 Electrical equipment for measurement,

control and laboratory use - EMC requirements.

IEC/EN 60825-1 Safety of laser products - Part 1:

Equipment classification and requirements.

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.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

Contact addresses

For research use only. Not for use in diagnostic

procedures.

Complies with the provisions of the applicable EU

directives.

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive

Tucson, Arizona 85755

USA

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

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Table of contents 7

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

Table of contents

Publication information 3

Contact addresses 5

Table of contents 7

Intended use 9

Intended purpose 9

Symbols and abbreviations 9

What is new in publication version 1.0 11

Safety

6 General safety information

Introduction 17

Safety classifications 18

Safety training 19

Safety precautions 20

Warning messages 23

Caution messages 26

Notices 30

Safety labels on the instrument 32

Safety information for lasers 34

Safety information for disposal 35

System description

8 System overview

Instrument overview 41

Computer and peripherals overview 47

Ventana System Software overview 50

About the data network 56

List of system specifications 58

Operation

10 System operation

Slide staining run quick start guide 67

Preparing for a staining run 69

Performing a staining run 92

After a staining run 117

Managing orders 127

Preparing bulk reagents 143

Managing waste carboys 150

11 Configuration

Starting and stopping the system 161

Setting up the system 170

Setting up users 186

Managing staining protocols 200

Creating and modifying slide label

templates 222

Maintaining the slide label printer 239

Managing inventory 255

Maintaining quality control 286

12 Maintenance

List of maintenance intervals 301

Logging completed maintenance 302

List of allowed cleaning fluids 304

Daily maintenance 305

Weekly maintenance 308

Monthly maintenance 311

Quarterly maintenance 314

Other scheduled maintenance 334

Printing maintenance reports 340

13 Error messages

Managing error messages 343

List of error messages 347

Troubleshooting by using function tests 387

8 Table of contents

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

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Intended use

The DISCOVERY ULTRA Research Staining System is

intended to automatically stain histological or cytological

specimens on microscope slides with specific

immunohistochemistry or in situ hybridization reagents

for research use only. Evolved from the DISCOVERY

series of instruments, the DISCOVERY ULTRA instrument

fully automates the processes of baking,

deparaffinization, and staining.

Intended purpose

The system is intended to be run by trained laboratory

personnel, such as histotechnologists and laboratory

technicians, who are researchers experienced in histology

processes and have basic computer operation skills. The

system is intended to be installed in a research laboratory

environment and must be used in a manner consistent

with industry practices for safety, security, regulatory,

environmental, ergonomic, workflow, and information

technology.

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the

following product names and descriptors are used.

Symbols used in the publication

Product name Descriptor

DISCOVERY ULTRA instrument

DISCOVERY ULTRA system

DISCOVERY ULTRA staining system

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.

Symbol Explanation

y Symbols used in the publication

Abbreviation Definition

CC Cell conditioning

CSA Canadian Standards Association

IEC International Electrical

Commission

ISH In situ hybridization

IVD In vitro diagnostic

LCS Liquid coverslip

LIS Laboratory information system

n/a Not applicable

PDF Portable document format

QC Quality Control

RAP Reagent access point

RUO Research Use Only

SSC Sodium chloride sodium citrate

SLS Slide Labeling System

UL Underwriters Laboratories Inc.

VLM Ventana Lab Manager

VSS Ventana System Software

y Abbreviations

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

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What is new in publication version 1.0

The changes listed in this section describe the major

differences between the VENTANA DISCOVERY ULTRA

Instrument (Research Use Only) User Guide and for

Ventana System Software 12.3/12.4 (D12373) and the

VENTANA DISCOVERY ULTRA Instrument (Research Use

Only) User Guide for Ventana System Software 12.5

(D135664).

New Functionality This is a list of the new functionality documented in this

guide.

• User name and password creation are required for

Create/Edit Protocols and Manage Protocols views.

• Multiple types of BenchMark and/or DISCOVERY

instruments can be connected to 1 host PC

• VENTANA Connect replaces VIP

• Use of a Zebra slide label printer

• Protocols can be marked as active and validated

• Protocol version history can be viewed and compared

New topics This lists the topics that are new in this guide.

u About VLM and VENTANA Connect (179)

u Maintaining the Zebra slide label printer (239)

u About Active and Validated Protocols (200)

u Viewing and comparing a protocol’s history (214)

Roche Diagnostics

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Roche Diagnostics

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Safety

6 General safety information ................................................................................. 15

6 General safety information

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Table of contents

General safety information 6

In this chapter

6

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Safety training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

About operator qualification . . . . . . . . . . . . . . . . . . 20

About safe and proper use of the instrument . . . 20

Miscellaneous safety precautions overview . . . . . 22

Warning messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Electrical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 24

Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Instrument location . . . . . . . . . . . . . . . . . . . . . . . . . 25

Caution messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Burns due to hot surfaces . . . . . . . . . . . . . . . . . . . . 26

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

Reagents and other working solutions . . . . . . . . . 27

Fatigue due to long hours of operation . . . . . . . . . 28

Electromagnetic interference . . . . . . . . . . . . . . . . . 28

Data security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Safety labels on the instrument . . . . . . . . . . . . . . . . . . 32

List of safety labels on the instrument. . . . . . . . . . 32

Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 34

Laser presence detector and bar code reader . . . 34

Safety information for disposal. . . . . . . . . . . . . . . . . . . 35

Disposal information . . . . . . . . . . . . . . . . . . . . . . . . 35

6 General safety information

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Table of contents

6 General safety information

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

General safety information 17

Introduction

!

General attention

To avoid serious or fatal injury, read the safety information

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

may be impaired.

6 General safety information

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

18 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 injury, or death.

The following 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 injury.

CAUTION

!

Caution...

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

could result in minor or moderate injury.

NOTICE

Notice...

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

may result in damage to the instrument.

Important information that is not safety relevant is

indicated with the following icon:

q Tip...

...indicates additional information on correct use or useful

tips.

6 General safety information

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

General safety information 19

Safety training

All operators must be trained in the safe use of the

DISCOVERY ULTRA instrument. After training, operators

must demonstrate an understanding of the following:

• The instrument must be connected to a grounded

outlet.

• The instrument must be connected to a voltage source

that complies with the rating label.

• Using instruments in a manner not specified by Roche

may impair protection provided by the equipment.

• Only Roche service representatives can replace filters

and tubing.

• Because of the moving parts, operators must use

caution when interacting with the reagent carousel

and dispensers or when changing reagents during a

reagent access point.

• Operators must consult the Safety Data Sheets (SDS)

for instructions for safe handling and disposal of

reagents used with the instrument.

6 General safety information

Roche Diagnostics

VENTANA DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5 · User Guide · D135664 Version 1

20 Safety precautions

Safety precautions

!

To avoid serious or fatal injury, read and

comply with the following safety precautions.

In this section

About operator qualification (20)

About safe and proper use of the instrument (20)

Miscellaneous safety precautions overview (22)

About operator qualification

Insufficient knowledge and skills As an operator, ensure that you know the relevant safety

precaution guidelines and standards and the information

and procedures contained in these instructions.

r Do not carry out operation and maintenance unless

you have been trained to do so.

r Leave maintenance, installation, or service that is not

described to trained Roche service representatives.

r Carefully follow the procedures specified in the

instructions for operation and maintenance.

About safe and proper use of the instrument

Missing personal protective equipment Working without personal protective equipment means

danger to life or health.

r Wear appropriate personal protective equipment,

including, but not limited to, the following items:

o Eye protection with side shields

o Fluid-resistant laboratory coat

o Approved laboratory gloves

o Face shield (if there is a chance of splashing or

splattering)

r Follow good laboratory practices and regularly change

gloves to minimize the risk of infection and

contamination (especially after contact with waste or

sample material).

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