Roche DISCOVERY ULTRA User manual

DISCOVERY ULTRA Instrument

(Research Use Only)

User Guide

D138340 Version 4

Software Version 12.5.4

Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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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.

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. User Assistance was not included.

2 12.5 - 12.5.2 October 2018 Minor corrections to content, reformatting graphics, and

addition of User Assistance.

3 12.5.3 November 2019 Made minor corrections to content, replaced screenshots, and

added updates for software version 12.5.3.

4 12.5.4 June 2020 Removed VENTANA from cover, title page, footer, and other

content.

Added new topics:

o Slide label and printer sections for new Zebra printer.

o Statements in the Safety section for system not used for an

extended period and use of QC tests for proper use of the

system.

o Setting up user groups for daily, advanced, and super user.

In the Safety section, updated text in the following sections:

o Safety Precautions

o Electrical safety

o Waste

o Mechanical safety

o Reagents and other working solutions

o Electromagnetic interference

o Data security

o Notices

o Disposal information

Updated text in the following sections:

o List of System Specifications, added table for Zebra printer.

o Creating and printing slide labels, added recommendation

for reviewing protocol on printed slide labels.

o Deleting an order, added tip for discarding labels.

o Setting Katakana and slide data type options, added tip for

checking fields on printed labels.

o Registering a new user-fillable dispenser, added use by

date.

o Adding a user group, updated to create daily, advanced,

and super user groups and recommended privileges.

y Revision history

Roche Diagnostics

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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.

!

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.

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 Roche

support.

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 Roche support, or

perform such updates with their assistance.

Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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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, VENTANA

CONNECT, 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 Roche support, 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.

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:

Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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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

···

7

Publication information 3

Contact addresses 6

Intended use 9

Intended purpose 9

Symbols and abbreviations 9

What is new in publication version 1 11

Safety

1 General safety information

Introduction 17

Safety classifications 18

Safety training 19

Safety precautions 20

Warning messages 24

Caution messages 27

Notices 33

Safety labels on the instrument 35

Safety information for lasers 37

Safety information for disposal 38

System description

2 System overview

Instrument overview 43

Computer and peripherals overview 49

Ventana System Software overview 52

About the data network 58

List of system specifications 60

3 User Assistance

About the User Assistance 67

Starting the User Assistance 68

Searching in the User Assistance 69

Browsing in the User Assistance 70

Using the hardware explorer in the User

Assistance 71

Viewing a list of recent topics in the User

Assistance 72

Bookmarking a topic in the User Assistance 73

Viewing a video in the User Assistance 74

List of videos in the User Assistance 75

Operation

4 System operation

Slide staining run quick start guide 83

Preparing for a staining run 85

Performing a staining run 108

After a staining run 134

Managing orders 144

Preparing bulk reagents 159

Managing waste carboys 166

Roche Diagnostics

···

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5 Configuration

Starting and stopping the system 177

Setting up the system 186

Setting up users 202

Managing staining protocols 218

Creating and modifying slide label

templates 241

Maintaining the slide label printer 258

Managing inventory 280

Maintaining quality control 311

6Maintenance

List of maintenance intervals 325

Logging completed maintenance 326

List of allowed cleaning fluids 328

Daily maintenance 329

Weekly maintenance 332

Monthly maintenance 335

Quarterly maintenance 338

Other scheduled maintenance 357

Printing maintenance reports 364

7 Error messages

Managing error messages 367

List of error messages 371

Zebra printer error messages and

troubleshooting 412

Troubleshooting by using function tests 414

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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.

Search. Used on the search tab in the User

Assistance.

Table of contents. Used on the table of

contents tab in the User Assistance.

History. Used on the history tab to show

previously viewed topics in the User

Assistance.

Favorites. Used on the favorites tab and on the

content panel in the User Assistance.

Enlarge. Button used on images in the User

Assistance.

Settings. Button used to open the settings

dialog in the User Assistance.

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

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What is new in publication version 1

The following changes were made for the VENTANA

DISCOVERY ULTRA Instrument User Guide and User

Assistance for Ventana System Software 12.5.4.

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

guide.

• Maintenance sections for loading label rolls and

thermal ribbons for the Zebra printer

• Label type options in the Slide Labeling System (SLS)

for the Zebra printer

• Error messages and troubleshooting for the Zebra

printer

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

u FortiGate firewall (63)

u Loading a label roll onto the Zebra slide label

printer (269)

u Loading a thermal transfer ribbon onto the Zebra slide

label printer (271)

u Cleaning the Zebra printhead (273)

u Zebra printer error messages and

troubleshooting (412)

u To add the daily user group p (212)

u To add the advanced user group p (213)

u To add the super user group p (214)

User Assistance The DISCOVERY ULTRA user guide is available in

portable document format (PDF) and an interactive help

system (User Assistance). The User Assistance contains

videos and a hardware explorer that are not included in

the PDF.

Roche Diagnostics

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Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

Safety

1 General safety information.................................................................................. 15

1 General safety information

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Table of contents

General safety information 1

In this chapter

1

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 . . . . . 23

Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Electrical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 25

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

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

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

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

Mechanical safety . . . . . . . . . . . . . . . . . . . . . . . . . . 28

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

Fatigue due to long hours of operation . . . . . . . . . 29

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

Data security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Safety labels on the instrument . . . . . . . . . . . . . . . . . . 35

List of safety labels on the instrument. . . . . . . . . . 35

Safety information for lasers . . . . . . . . . . . . . . . . . . . . . 37

Laser presence detector and bar code reader . . . 37

Safety information for disposal. . . . . . . . . . . . . . . . . . . 38

Disposal information . . . . . . . . . . . . . . . . . . . . . . . . 38

1 General safety information

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Table of contents

1 General safety information

Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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.

r Keep this manual in a safe place to ensure that it is

not damaged and remains available for use. This

manual must always be easily accessible.

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.

1 General safety information

Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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.

1 General safety information

Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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 support 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.

1 General safety information

Roche Diagnostics

DISCOVERY ULTRA Instrument (Research Use Only) · Software Version 12.5.4 · User Guide · D138340 Version 4

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 (23)

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 Roche support.

r Carefully follow the procedures specified in the

instructions for operation and maintenance.

r Follow standard laboratory practices and regularly

change gloves to minimize the risk of infection and

contamination when you work with biohazardous

material (especially after contact with waste or sample

material).

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)

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