Roche VENTANA DP 200 User manual

2019-03-15

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VENTANA DP 200 slide scanner

IVD User Guide

1017149EN Rev. C

Software version 1.1

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · Part No.: 1017149EN Rev. C

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VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

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Publication information

Edition notice This publication is intended for operators of the

VENTANA DP 200 slide scanner.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, Ventana Medical Systems,

Inc. reserves the right to modify its hardware and

software at anytime.

Where to find information This User Guide contains information on configuration,

routine operation, maintenance, safety, and

troubleshooting.

Training Do not carry out operation tasks or maintenance actions

unless you have received training from Roche Service.

Leave tasks that are not described in the user

documentation to be performed by trained Roche Service

representatives.

Screenshots The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data, such as tests, results, or path names visible

therein must not be used for laboratory purposes.

reserved.

License information VENTANA DP 200 software is protected by contract law,

copyright law, and international treaties. The software

contains a user license between Ventana Medical

Systems, Inc. and a license holder, and only authorized

users may access the software and use it. Unauthorized

use and distribution may result in civil and criminal

penalties.

Publication

version

Software version Revision date Change description

Rev. A 1.0 March 2018 First version

Rev. B 1.0 March 2019 Updated manufacturer address and EC REP address. Updated

the version letter in manual part number.

Rev. C 1.1 November 2019 Release of version 1.1

y Revision history

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

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Open Source and Commercial Software VENTANA DP 200 slide scanner may include components

or modules of commercial or open-source software. For

further information on the intellectual property and other

warnings, as well as licenses pertaining to the software

programs included in the scanner, refer to the electronic

distribution included with this product and below.

This open source and commercial software and the

VENTANA DP 200 slide scanner as a whole can

constitute a device regulated in accordance with

applicable law.

Please note that the respective authorization is no longer

valid according to the corresponding legislation should

any unauthorized changes be made to the

VENTANA DP 200 slide scanner.

Permission to use, copy, modify, distribute, and sell this

software and its documentation for any purpose is hereby

granted without fee, provided that (i) the above copyright

notices and this permission notice appear in all copies of

the software and related documentation, and (ii) the

names of Sam Leffler and Silicon Graphics may not be

used in any advertising or publicity relating to the

software without the specific, prior written permission of

Sam Leffler and Silicon Graphics.

THE SOFTWARE IS PROVIDED "AS-IS" AND WITHOUT

WARRANTY OF ANY KIND, EXPRESS, IMPLIED, OR

OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY

WARRANTY OF MERCHANTABILITY OR FITNESS FOR A

PARTICULAR PURPOSE. IN NO EVENT SHALL SAM

LEFFLER OR SILICON GRAPHICS BE LIABLE FOR ANY

SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL

DAMAGES OF ANY KIND, OR ANY DAMAGES

WHATSOEVER RESULTING FROM LOSS OF USE, DATA

OR PROFITS, WHETHER OR NOT ADVISED OF THE

POSSIBILITY OF DAMAGE, AND ON ANY THEORY OF

LIABILITY, ARISING OUT OF OR IN CONNECTION WITH

THE USE OR PERFORMANCE OF THIS SOFTWARE.

Trademarks The following trademarks are acknowledged:

VENTANA, CAREGIVER, UPATH, VENTANA VECTOR,

VIRTUOSO, and the VENTANA logo are trademarks of

Roche. All other trademarks are the property of their

respective owners.

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

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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 DP 200 slide scanner meets the

requirements laid down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro diagnostic medical

devices.

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:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

directives.

ETL by Intertek.

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Contact addresses

FFEI Ltd.

The Cube, Hemel Hempstead Industrial Estate

Maylands Ave.

Hemel Hempstead HP2 7DF

UK

Made in the UK

Manufactured for

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive

Tucson, Arizona 85755

USA

www.ventana.com

Distributed in the USA by

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana 46256

USA

Distributed globally by

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Table of contents 7

VENTANA DP 200 slide scanner · Software version 1.0.0 · IVD User Guide · 1017149EN Rev. C

Table of contents

Publication information 3

Contact addresses 6

Table of contents 7

Intended use 9

Symbols and abbreviations 9

What is new in publication version 1.1 12

Safety

1 General safety information

Introduction 17

Safety classifications 17

Safety precautions 18

Warning messages 21

Cautions 24

Notices 25

Safety labels on the VENTANA DP 200 slide

scanner 29

Safety information for disposal 33

Operation

2 Overview of the VENTANA DP 200 slide scanner

The VENTANA DP 200 slide scanner 39

3 Overview of the VENTANA DP 200 Scan Application

VENTANA DP 200 Scan Application

overview 47

Overview of status indicators, notifications, and

warning messages 75

4 Scanning workflow

Starting the scanner 83

Performing a scan workflow 85

Shutting down the scanner 92

5 VENTANA DP 200 Scan Application configuration

About VENTANA DP 200 Scan Application

configuration 97

6 Calibration, diagnostics, and maintenance

Calibration and diagnostics 109

Maintenance 117

7 Troubleshooting and diagnostics

About calibration and diagnostic tests for

troubleshooting 123

Troubleshooting 129

Error codes 138

Appendix

8 Specifications

VENTANA DP 200 slide scanner

specifications 147

Supporting Materials 149

Slide preparation requirements 152

9 Glossary

8 Table of contents

VENTANA DP 200 slide scanner · Software version 1.0.0 · IVD User Guide · 1017149EN Rev. C

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

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Intended use

VENTANA DP 200 The VENTANA DP 200 slide scanner is a computer and

imaging based device that has the capability to scan,

digitize, compress, store, retrieve, and view digitized

images of slide specimens.

When used with VENTANA Image Viewer, the

VENTANA DP 200 slide scanner provides automated

digital slide creation, management, and viewing

capabilities to aid pathologists with in-vitro examination

of human tissue specimens.

VENTANA DP 200 with Virtuoso software The VENTANA DP 200 slide scanner is a computer and

imaging based device that has the capability to scan,

digitize, compress, store, retrieve, and view digitized

images of slide specimens.

When used with Virtuoso Image Management Software,

the VENTANA DP 200 slide scanner provides automated

digital slide creation, management, and viewing to aid

pathologists with in-vitro examination of human tissue

specimens. The VENTANA DP 200 slide scanner with

Virtuoso software is intended for digital read applications

of immunohistochemically stained tissue slides of

cytoplasmic, nuclear, or membranous staining.

Symbols and abbreviations

Product names and definitions Except where the context clearly indicates otherwise, the

following product names and descriptors are used:

Product name Descriptor

VENTANA DP 200 slide

scanner

Instrument, scanner, slide

scanner, or system

VENTANA DP 200 PC PC

VENTANA DP 200 Scan

Application

Scan Application

VENTANA DP 200 Instrument

Instrument, scanner, or slide

scanner

VENTANA DP 200 slide trays Slide trays

VENTANA DP 200 software

Software (All software

included with the slide

scanner; e.g., Scan

Application and Calibrations

and Diagnostics Utility

(CDU))

y Product names

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

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Symbols used in the publication

Symbols used on product

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.

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.

y Symbols used in the publication

Symbol Explanation

2D barcode containing the instrument’s serial

number, GTIN number, REF number, and

Roche product code.

Biohazardous materials warning.

European Conformity marking for the product.

Consult user documentation.

Date of manufacture.

Eject slide tray (found on the Eject button

located on the front of the instrument).

ETL mark.

y Symbols used on product

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Abbreviations The following abbreviations are used.

General warning.

Global Trade Item Number.

High-intensity LEDs present that may be

harmful to the eye.

For in vitro diagnostic use.

Magnetic field present in the vicinity of the

label.

Manufacturer's name and address.

Pacemakers and implantable cardioverter-

defibrillators (ICDs) may be adversely affected.

Reference number (manufacturer's product

code).

Serial number.

Authorized representative in the European

community.

Symbol Explanation

y Symbols used on product

GTIN

Abbreviation Definition

AOI Area of interest

CDU

Calibrations and Diagnostics

Utility

DICOM

Digital Imaging and

Communications in Medicine

EC European Community

EN European Standard

HR High resolution

ICC International Color Consortium

ICD

Implantable cardioverter-

defibrillator

y Abbreviations

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

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What is new in publication version 1.1

The changes listed in this section describe the major

differences between the VENTANA DP 200 slide scanner

User Guide for software version 1.0 and version 1.1.

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

guide.

• Spot Check Viewer is now an embedded Viewer.

• Focus Method changed to Scan Method.

• Label Anonymization changed to De-identify Label.

• White Balance Calibration can be configured.

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

u Interactive White Balance Calibration (62)

u Configuring instrument (105)

IEC

International Electrical

Commission

IMS Image Management System

IVD In vitro diagnostic

MTF Modulation transfer function

N/A Not applicable

PC Personal computer

PM Preventative maintenance

SDS Safety data sheet

UI User interface

Abbreviation Definition

y Abbreviations

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

Safety

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

1 General safety information

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

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Table of contents

General safety information 1

In this chapter

1

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

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Operator qualification . . . . . . . . . . . . . . . . . . . . . . . 19

Installation and relocation . . . . . . . . . . . . . . . . . . . . 19

Operating conditions . . . . . . . . . . . . . . . . . . . . . . . . 20

Safe and proper use of the VENTANA DP 200

slide scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Miscellaneous safety precautions . . . . . . . . . . . . . 21

Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Electrical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Biohazardous materials . . . . . . . . . . . . . . . . . . . . . . 23

Pacemaker or ICD safety . . . . . . . . . . . . . . . . . . . . . 23

Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Cuts and eye injuries from broken slides . . . . . . . 24

Eye injury from intense light from LEDs . . . . . . . . 24

Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Damage to the operating system . . . . . . . . . . . . . . 25

Damage from strong magnetic field . . . . . . . . . . . 26

Spillage and foreign objects . . . . . . . . . . . . . . . . . . 26

Data security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Opening and removing panels . . . . . . . . . . . . . . . . 28

Damage to optical components . . . . . . . . . . . . . . . 28

Damage to mechanical components . . . . . . . . . . . 28

Safety labels on the VENTANA DP 200 slide scanner 29

List of safety labels on the VENTANA DP 200

slide scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Location of safety labels on the VENTANA DP

200 slide scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Safety information for disposal. . . . . . . . . . . . . . . . . . . 33

Disposal information . . . . . . . . . . . . . . . . . . . . . . . . 33

1 General safety information

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Table of contents

1 General safety information

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

General safety information 17

Introduction

!

General attention

To avoid injury, read this publication thoroughly before

you use the VENTANA DP 200 slide scanner.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication and

heed all warnings posted on the system.

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

this publication.

r Keep this publication in a safe place to ensure that it

is not damaged and remains available for use. This

manual must always be easily accessible.

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

VENTANA DP 200 slide scanner, 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 injury.

CAUTION

!

Caution...

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

could result in minor or moderate injury.

1 General safety information

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

18 Safety precautions

NOTICE

Notice...

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

may result in damage to the VENTANA DP 200 slide

scanner.

Important information that is not safety relevant is

indicated with the following icon:

q Tip...

...indicates additional information on correct use or useful

tips.

Safety precautions

!

To avoid serious or fatal injury, read and

comply with the following safety precautions.

In this section

Operator qualification (19)

Installation and relocation (19)

Operating conditions (20)

Safe and proper use of the VENTANA DP 200 slide

scanner (20)

Miscellaneous safety precautions (21)

1 General safety information

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

General safety information 19

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

Roche has trained you to do so.

r Leave maintenance, installation, or service that is not

described in this user guide to trained Roche Service

representatives.

r Carefully follow the procedures specified in the

instructions for operation and maintenance of the

VENTANA DP 200 slide scanner.

r Follow standard laboratory practices, especially when

you work with biohazardous material.

Installation and relocation

Errors in installation Only trained Roche Service representatives may install

the scanner.

r Wait for Roche Service representatives to set up the

scanner.

Errors in moving Only trained Roche Service representatives may relocate

or prepare the scanner for shipping.

r If you need to move or ship the scanner to a new site,

contact Roche Support.

1 General safety information

VENTANA DP 200 slide scanner · Software version 1.1 · IVD User Guide · 1017149EN Rev. C

20 Safety precautions

Operating conditions

Unsuitable operating conditions Operation outside of the ranges and conditions specified

below may lead to incorrect results or malfunction of the

system.

r Refer to the Specifications chapter for the operating

temperature range, relative humidity, and setback

requirements.

r Do not place the system on any cart, stand, tripod,

bracket, or table that is unstable.

r Do not place the system in close proximity to other

devices that generate vibrations.

r Do not use the system near any heat sources such as

radiators, heat registers, stoves, or other products that

produce heat.

r Do not place the system near large windows to avoid

prolonged exposure to direct sunlight.

r Make sure that the system’s ventilation openings

remain unobstructed. These openings must not be

blocked or covered during operation.

r Do not use the system near water, such as a water

bath, wash bowl, or sink. Avoid other possible water

hazards.

u Related topics

• Specifications (145)

Safe and proper use of the VENTANA DP 200 slide

scanner

Personal protective equipment r Follow your laboratory’s standard operating

procedures regarding personal protective equipment.

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Roche VENTANA DP 200 User manual

Roche VENTANA DP 200 User manual

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