Roche iScan HT IVD User manual

Ventana Medical Systems, Inc.

www.ventana.com

Part No.: Part No.: PL-000119-EN Rev. H

May 2019

VENTANA iScan HT User Guide

Version 1.1

ii VENTANA iScan HT User Guide

VENTANA iScan HT User Guide

Copyright

Trademarks

VENTANA, VIRTUOSO, ISCAN, and the VENTANA logo are trademarks of Roche. All other trademarks are the property of their

respective owners.

Open Source And Commercial Software

Portions of the VENTANA iScan HT slide scanner might include one or more Open Source or Commercial Software programs. For

copyright and other notices and licensing information regarding such Software programs included with the VENTANA iScan HT slide

scanner please see Appendix D of the reference guide and the product on-line help pages included with the product.

The VENTANA iScan HT slide scanner as a whole may form a regulated device in accordance with the applicable laws - please refer to

the reference guide and the labeling for details. Please note that the respective authorization in accordance with the applicable laws lapse

in case of any unauthorized changes to the VENTANA iScan HT slide scanner. Any patient information depicted in this guide is fictitious

and for exemplary purpose only.

Contact

www.ventana.com

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive

Tucson, AZ 85755

USA

+1 520 887 2155

+1 800 227 2155 (USA)

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

+49 621 7590

Part No.: PL-000119-EN Rev. H iii

Table of Contents

About the VENTANA iScan HT Slide Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Welcome!. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

This Guide Includes Instructions to:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Intended Use for the VENTANA iScan HT Slide Scanner: . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Who Should Read this Guide? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

What’s in this Guide?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1: Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Instrument Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Work Surface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

AC Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Local Area Network (LAN) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Telephone Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Software Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Computer and Monitor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Compliance Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Hardware Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Cyber Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Securing Networks and Servers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Protecting Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Evaluate Your Software Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Backup and Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Environmental Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Slide Specifications and Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Standard Slide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2: Operating the Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

General Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Starting the VENTANA iScan HT Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Main View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Main View Menu Pull-Downs . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Scanner LCD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

The Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Selecting Racks in the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Viewing Rack Status in the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Worklist Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Modifying the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Interrupting the Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Aborting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

3: Setting System Defaults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

General Tab - Application Settings and Values: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Changing General Settings Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

File Management Tab - Settings and Values: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Changing File Management Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

iv Ventana Medical Systems, Inc.

VENTANA iScan HT User Guide

Scan Profile Tab - Settings and Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Scan Profile Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Creating a Scan Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Viewing a Scan Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Updating a Scan Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Deleting a Scan Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4: Rack Level Processing and Editing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Create Thumbnails and/or Scans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Scan Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Interrupting the scan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Changing Settings and Controls For the Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Selecting Racks for Editing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Changing the Scan Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Saving Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Focus Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Magnification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

AOI Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Enable Volume Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Folder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Annotations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

5: Slide Level Editing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Slide List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Slide List Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Slide List Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Changing Slide Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Saving Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Changing the Scan Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Creating a Thumbnail or Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Editing Slides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Open/View a Slide in the Thumbnail Pane . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Inspect AOI and Focus Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Modifying the AOI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Scan the Slide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Using the Image Viewer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Re-Scan a Slide after a Successful Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

6: File Management Utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

To access the File Management Utility: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

A: Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

System Abort . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Recovery Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Possible Recovery Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Hard Restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Power Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Unrecoverable Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Starting the Recovery Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Error Handling in General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Power Failure or Abort. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Scanner Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Part No.: PL-000119-EN Rev. H 1

About the VENTANA iScan HT Slide Scanner

Welcome!

The VENTANA iScan HT slide scanner incorporates cutting edge optical, focus, and slide handling technologies to address

the high-volume needs of the anatomic pathology laboratory. Combining accurate area of interest (AOI) detection and industry

leading scan times, with reliable slide handling, the VENTANA iScan HT slide scanner empowers your laboratory to manage

high-throughput exceptional quality digital pathology images.

The VENTANA iScan HT slide scanner is fully integrated with the Virtuoso workflow management software, making it a

complete digital pathology solution from image acquisition through reporting. Only the VENTANA iScan HT slide scanner

from Ventana Medical Systems, Inc., a global leader in anatomic pathology delivers true workflow optimization in your

pathology laboratory.

This Guide Includes Instructions to:

• Safely handle and work with the scanner.

• Use the scanner to perform a one-touch, walk-away scan of one or more slides.

• Use the scanner to perform a manual scan of one or more slides.

• Use the Image Viewer to view digital-scanned slides locally or remotely.

Intended Use for the VENTANA iScan HT Slide Scanner:

Ventana's VENTANA iScan HT slide scanning system is a computer and imaging based device for in-vitro examination of

human tissue specimens. The system has the capability to scan, digitize, compress, store, retrieve and view digitized images of

human tissue slide specimen.

Who Should Read this Guide?

• Pathologists and/or Technologists using the scanner to scan slides

• Pathologists and/or Technologists using Image Viewer to view digital images of slides. See the Image Viewer Reference

Guide for additional information.

What’s in this Guide?

Safety Requirements and Notifications

“1: Safety Information” on page 3

Scanner Operations

“2: Operating the Scanner” on page 13

System Defaults

“3: Setting System Defaults” on page 23

Rack Process and Editing

“4: Rack Level Processing and Editing” on page 41

Slide Level Editing

“5: Slide Level Editing” on page 49

File Management Application

“6: File Management Utility” on page 71

Troubleshooting Information

“A: Troubleshooting” on page 75

2 Ventana Medical Systems, Inc.

About the VENTANA iScan HT Slide Scanner VENTANA iScan HT User Guide

Related Documents

For additional information, see the VENTANA iScan HT Reference Guide, the Virtuoso Reference Guide, and the Image

Viewer Reference Guide.

Part No.: PL-000119-EN Rev. H 3

1: Safety Information

You must read and understand and follow the safety requirements and notifications in this chapter before using the VENTANA

iScan HT slide scanner.1:

Instrument Labels

CAUTION: THE VENTANA iScan HT SLIDE SCANNER GENERATES, USES, AND

CAN RADIATE RADIO FREQUENCY ENERGY.

If not installed and used in accordance with the instructions in this guide, the scanner may cause

interference to radio communications. The scanner has been tested and found to comply with the

limits for a Class A computing device (pursuant to Subpart B of Part 15 FCC Rules), which are

designed to provide reasonable protection against such interference when the scanner is operated

in a commercial environment. Operation of the scanner in a residential area can cause

interference, in which case the user, at his own expense, will be required to take whatever

measures necessary to correct the interference.

CSA

ATTENTION: CONSULT ACCOMPANYING DOCUMENTS.

CAUTION: REPLACE FUSE ONLY WITH A UL LISTED OR RECOGNIZED 250V

2A RATED FUSE.

ATTENTION: DISPOSAL OF THE SCANNER UNIT MUST BE PERFORMED UNDER WASTE

ELECTRICAL AND ELECTRIC EQUIPMENT (WEEE) GUIDELINES.

4 Ventana Medical Systems, Inc.

1: Safety Information VENTANA iScan HT User Guide

Safety Instructions

Operating Instructions

• Read all safety and operating instructions before operating the scanner.

• Retain all safety and operating instructions for future reference.

Posted and Written Warnings

• Heed all warnings posted on the scanner and listed in the operating instructions.

Product Use Instructions

• Follow all operating and product use instructions.

Heat

• The scanner must be situated away from any heat sources such as radiators, heat

registers, stoves, or other products that produce heat.

Ventilation

• Slots and openings in the scanner provide ventilation. They insure reliable

operation of the scanner, keeping it from overheating. These openings must not be

blocked or covered during operation.

Water and Moisture

• Do not use the scanner near water; for example, near a water bath, wash bowl,

kitchen sink or laundry tub; in a wet basement; or near an open pool of water, or

other possible water hazards.

Attachments

• Do not use any attachments that are not recommended, as they may cause

hazards.

Power Sources

• The scanner must be operated from the type of power source indicated on the

marking label and in the installation instructions. If you are not sure of the type of

power supply to your facility, consult your local power company.

Grounding and Polarization

• The scanner is equipped with a polarized AC plug with integral safety ground pin.

Do not defeat the safety ground in any way, shape, or form.

Power Cord Protection

• Power supply cords must be routed so that they are not walked on or pinched by

items placed on or against them. Pay particular attention to the cords at AC wall

plugs and convenience receptacles, and at the point where the cord enters the

product.

• Power supply cords must be readily accessible in case power to the unit must be

intentionally interrupted.

Lightning

• For added protection for the scanner during a lightning storm, or when the scanner

is left unattended and unused for long periods of time, unplug the scanner from the

AC wall outlet. This will prevent damage to the scanner due to lightning and power

line surges.

Power Loss

• In the event of a loss of power during the scanning or thumbnailing process, the

VENTANA iScan HT slide scanner will rely on power from the universal power

supply (UPS) to keep the vacuum on. You should use the Recovery Console and

follow the procedures to return slides to the rack.

Overloading

• Do not overload AC wall outlets, extension cords, or integral convenience outlets;

this can result in a fire or an electric shock hazard.

Object and Liquid Entry

• Never push objects of any kind into the scanner through openings in the scanner;

they may touch dangerous voltage points or short out parts, possibly resulting in a

fire or electric shock. Never spill liquid of any kind on the scanner. Do not place

liquids on the scanner.

Accessories

• Do not place the scanner on an unstable cart, stand, tripod, bracket, or table. The

scanner could fall, causing serious personal injury and/or damage to the scanner.

• Any mounting of the scanner must be done according to the installation

instructions.

• Do not attempt to connect accessories or use cabling not explicitly provided for the

scanner.

Stationary Equipment

• The scanner should be moved only with extreme care. Quick stops, excessive

force, and uneven surfaces may cause the scanner to overturn.

VENTANA iScan HT User Guide 1: Safety Information

Part No.: PL-000119-EN Rev. H 5

Operating Environment

Work Surface

Neighboring Devices

• Electromagnetic interference (EMI) from external sources could affect scanner

operation. The scanner should be set off far enough from neighboring devices to

prevent any problems with EMI.

• Vibrations or jolts from neighboring devices can skew scanner performance. The

scanner should be set off far enough from neighboring devices to prevent any

problems caused by vibrations or jolts.

Network Connections

• The scanner must be set up and configured as specified in this document in order

to work properly over the Internet.

Insects

• Do not allow insects to find their way into the scanner. They could damage internal

parts and negatively impact scanner operation or performance.

Servicing

• Refer all servicing to Certified Service personnel.

Damage Requiring Service

• Unplug the scanner from the wall AC outlet and refer all servicing to Certified

Service personnel under the following conditions:

- When the AC cord or plug is damaged.

- If liquid is spilled on the scanner.

- If objects are dropped inside the scanner.

- If the scanner is exposed to rain or water.

- If the scanner does not operate normally (according to operating instructions).

- If the scanner is dropped or is damaged in any way.

- When the scanner exhibits a distinct change in performance. (This may indicate a

need for service.)

Replacement Parts

• When replacement parts are required, confirm that the Service Technician uses the

specified replacement parts. Unauthorized substitutions may result in fire, electric

shock, or other hazards.

Safety Check

• Upon completion of any repairs to the scanner, ask the Service Technician to

perform safety checks to determine that the scanner is in proper operating

condition.

Cleaning

• Do not use chemical cleaners or solvents. Use warm water with mild soap on a

damp, soft cloth; rinse and dry with a clean, damp cloth.

Product Disposal Instructions

• Dispose of any and all scanner parts according to the guidelines and regulations

specified by your city for electronic equipment and/or electronic component

disposal.

Lighting In work area: good and bright.

Air

In the room: clean and cool (67 to 76 degrees F / 19 to 24 degrees C), with maximum

humidity 30 to 80 percent.

Rigid Lab Bench Tabletop space: 60 x 30 (deep)

Weight Support To hold scanner unit and monitor: 800 lbs. (~363 kg)

User Access

In front of scanner: 3 ft. (minimum)

NOTE: The rear of the scanner near the power switch and the power connection

should be readily accessible so power to the unit can be cut or disconnected.

Space Beneath Bench To store computer that comes with scanner: 24 x 12 x 24 (high)

CAUTION: Replace fuse only with a UL Listed or

Recognized 250V 2A rated fuse.

6 Ventana Medical Systems, Inc.

1: Safety Information VENTANA iScan HT User Guide

AC Power

Figure 1-1. Electrical Plug and ON/OFF Switch.

Local Area Network (LAN)

Telephone Use

UPS

120 Volts

230 Volts

CAUTION: USE THE CORRECT POWER CORD.

If the power cord supplied with the scanner does not match the wall plug configuration, do not use

the cord. Contact Ventana Medical Systems, Inc. to obtain the proper cord. At least one grounded

dual AC wall socket (3-conductor) is recommended for a power source. A surge protector is also

recommended.

Network Internet access is required, with a fixed IP (or access through firewalls)

Transfer rate 100 Megabits per second

LAN connection, with Internet

access

Required for remote maintenance of the scanner over the Internet.

NOTE: A LAN connection is not required to operate the scanner. A LAN connection

is required only if remote access is necessary.

Location Near the scanner work area in the lab.

Use

Facilitates communication between technical personnel and scanner Operator (as

needed).

Fuse

Plug

On - Off switch

VENTANA iScan HT User Guide 1: Safety Information

Part No.: PL-000119-EN Rev. H 7

Software Compatibility

Please feel free to contact Ventana Technical Support if you have any additional questions regarding software compatibility.

Computer and Monitor Specifications

Compliance Specifications

CAUTION: DO NOT INSTALL MEMORY UPGRADES, DRIVERS, GRAPHIC,

VIDEO CARDS, EXTERNAL DEVICES, OR ANY OTHER HARDWARE

AND SOFTWARE ON THE WORKSTATION CONNECTED TO THE

SCANNER.

Such installations can interfere with the operation of the scanner. Contact Ventana Technical

Support (Tel (USA): +1 800 227 2155, or Tel: +1 520 887 2155; for Technical Support, press 1)

before installing any of the above items.

Do not install any other

software or hardware on the

system.

• Other software or hardware could interfere with scanner operation and void the

warranty.

The controller computer

comes with virus detection

software installed.

• The Antivirus software that comes with the scanner has been tested and validated

by Ventana. Ventana can guarantee the scanner's performance ONLY with

supported versions of Antivirus software. Ventana currently supports Symantec

Endpoint Protection v. 11, 64-bit.

• Virus definition files can be updated automatically.

• Do not update the Antivirus software to a new version. If you have any questions

regarding this or need to upgrade your Antivirus software, please call Ventana

Technical Support to verify that this will not create any performance issues.

Do not allow your scanner

to accept automatic

operating system updates

over the Internet.

• Automatic operating system updates over the Internet can interfere with scanner

operation.

• Please do not update your operating system without consulting someone from

Ventana Technical Support.

Scheduled or unscheduled

system software or

hardware backup or

maintenance.

• Backup or maintenance can interfere with scanner operation. Please call Ventana

Technical Support to verify that this will not create any performance issues.

Work Station Microsoft Windows; 64-bit Operating System

Storage Customer Usable Storage]- 2TB, SATA

Connectivity 2 GIGABIT Ethernet ports

Monitor 24 flat-panel, high-resolution monitor (1920 x 1200)

CE Safety EN61010-2

This device meets the safety requirements for electrical equipment for measurement,

control, and laboratory use.

8 Ventana Medical Systems, Inc.

1: Safety Information VENTANA iScan HT User Guide

Hardware Specifications

Cyber Security

Any device that is connected to a network (internally or externally) has the potential to be compromised by unauthorized

access or viruses. As with most devices, the VENTANA iScan HT slide scanner is designed to run on a computer utilizing

Micros oft Windows and virus protection software which requires the validation and implementation of the appropriate

patches.

Some of the potential cyber security hazards are:

• Malicious software that alters the device software (such as viruses)

• Unauthorized access to the scanner that could compromise data safety

• Security of data transmitted over the internet

Cyber security involves protecting data by preventing, detecting, and responding to malicious cyber attacks. Cyber attacks

could involve computer viruses which can completely erase data or hackers who alter files or even use the device as a host to

attack other devices. As serious as these hazards are, steps can be taken to maximize cyber security.

Securing Networks and Servers

Network security consists of the provisions made in the computer network infrastructure, policies adopted by the network

administrator to protect the network, and the network resources that prevent unauthorized access.

The following are critical steps for securing a network server:

• Physical security (servers and network infrastructure behind locked doors)

• Use of robust passwords

• System and data backups (at regular intervals)

• Data protection

• Terminating unused services

• Restricting access to used services

The following are critical steps and methodologies used to secure network and servers:

• Data protection

• Data backups (at regular intervals)

Input Format 25 mm x 75 mm microscope slides; 26 mm x 76 mm microscope slides

Slide Capacity 1 to 360 slides, using 18 integrated racks

Scanning Magnification 20X and 40X

Barcode Capability 1D and 2D option

Light Source Integrated LED

Touch-Screen LCD 10.1“ (257 mm) Diagonal, 1024 x 600 Resolution

Scan Viewing 24-bit true color

Slide Storage Format BIF and TIF

Dimensions

35.6” W x 27.5” D x 25.5” H

90.424 cm W x 69.85 cm D x 64.77 cm H

904.24 mm W x 698.5 mm D x 647.7 mm H

Scanner Weight Approximately 370 lbs. (~170 kg)

Power 100-220 VAC, 50/60 Hz, 400 W (includes light source)

Current 5 Amps

VENTANA iScan HT User Guide 1: Safety Information

Part No.: PL-000119-EN Rev. H 9

• Refusal of automatic updates from off-the-shelf software

• Antivirus software for computers and servers

Protecting Data

Establishment of a network firewall and protection of the network against viruses using anti-virus software are effective

methods to protect data. Virus definitions should be kept up to date and regular scans of computers for spyware should be

performed using a legitimate anti-spyware application. If viruses or spyware are found, remove them immediately.

Evaluate Your Software Settings

The default settings of most software enable all available functionality. However, hackers may be able to take advantage of

this functionality to access devices. It is especially important to check the settings for software that connects to the internet

(browsers, e-mail clients, etc.). Apply the highest level of security available that still provides needed functionality.

Backup and Recovery

In order to develop a successful backup and recovery plan, comprehension of data accessibility needs and the potential impact

of data loss is essential. Automatic backup procedures need to be adopted using a data backup utility.

Environmental Specifications

NOTE: Routine set up and alignment is required by certified technicians.

Use

The scanner is intended for use indoors in an office or lab environment, with a standard

connection to the MAINS electric power supply (115V/20A or 230V/16A). The unit falls

under the following category, as defined in IEC 61010-2 and IEC 60664: Pollution

Degree 2, Overvoltage Category 2.

Lab Standard lab cleanliness procedures

Altitude Up to 2000 meters

Room temperature Range: 70 ±4 degrees F; 21 ± 2 degrees C

Maximum humidity 90% (non-condensing)

Recommended Operating

Temperature

70 degrees F; 21 degrees C

Maximum Operating

Humidity

30-80%, non-condensing

Maximum Elevation 2000 Meters

Transportation Temperature -4 to +122 degrees F; -20 to +50 degrees C

MAINS supply voltage

fluctuations

• Up to ± 10% of 100-120 V in Japan/US

• Up to 220-240 V in Europe

• Transient overvoltages (category II of IEC 60364-4-443) typically present on

MAINS supply

10 Ventana Medical Systems, Inc.

1: Safety Information VENTANA iScan HT User Guide

Slide Specifications and Barcodes

The VENTANA iScan HT scanner allows you to scan up to 360 slides at the touch of a button and supports the use of standard

slides. This chapter includes specifications for slides and slide handling recommendations for use with the scanner and

configuring barcodes.

Standard Slide

Figure 1-2. Standard Slide.

Slide Length, Width, Thickness

NOTE: In order to work with the scanner, your slides must meet these specifications.

Slide Scannable Region

WARNING: DO NOT USE CRACKED OR BROKEN SLIDES.

Cracked or broken slides can adversely affect the operation of the scanner.

WARNING: DO NOT PLACE ANY BIOHAZARDOUS MATERIALS ON YOUR

SLIDES.

Length

2.965—3.013 inches (75.311—76.5302 mm)

Width

0.970—1.030 inches (24.6379—26.162 mm)

Thickness

0.038—0.055 inches (0.9652—1.397 mm); at label end, includes slide, label, and cover

slip.

Scannable Slide Region

Up to 1.816 x 1.030 Inches (46.1264 mm x 26.162 mm) maximum

The label and border is not scanned

(See Figure 1-3)

.

VENTANA iScan HT User Guide 1: Safety Information

Part No.: PL-000119-EN Rev. H 11

Slide Label Region

NOTE: One label can be placed over another (overlapping labels, or overlabeling), but a 0.157-inch (4-

mm) buffer must be maintained between the top edge of the label and the top edge of the slide.

For more information, see “Overlapping Labels (Overlabeling)” on page 12.

Figure 1-3. Slide Specifications.

Length

1 inch (25.40 mm)

Width

Same as Slide Width: 0.970—1.030 inches (24.6379—26.162 mm)

Thickness

Same as Slide Thickness: 0.038—0.055 inches (0.9652—1.397 mm). Includes slide and

label.

Barcode/Label

Slide Length: 2.965 — 3.013 Inches (75.311 — 76.5302 MM)

Slide Width:

0.970 — 1.030

Inches

Slide Thickness: 0.038 — 0.055 Inches (0.9652 — 1.397 MM)

(24.6379 —

26.162 mm)

At label End (Includes Slide and Label)

123456789

|||||||||

1 Inch

(25.40 mm)

Top Edge

of Slide

Scannable Region

2.013 x 1.030 Inches Max

(51.1302 mm x 26.162 mm)

1.965 x 0.970 Inches Min

(49.911mm x 24.638 mm)

= Not Scannable

12 Ventana Medical Systems, Inc.

1: Safety Information VENTANA iScan HT User Guide

Slide Label

Requirements:

• Each label must be placed on the same side of the slide as the tissue:

• Each label must fit in the designated label area.

• Each label must fit inside the boundary of the slide, without protruding over any edge.

• Each label must adhere securely to the slide.

• All label adhesive must be removed from each slide (adhesive can stick to the slide grabber, causing a slide to break).

• If one label is placed over another (overlapping labels, or overlabeling, see below), ensure that a 0.157 inch (4 mm) buffer

exists between the top edge of the label and the top edge of the slide.

Overlapping Labels (Overlabeling)

Labels can be overlapped, but this practice is not recommended.

Overlabeling Rule

If one label is placed over another, a 0.157 inch (4 mm) buffer must be maintained between the top edge of the label and the

Roche iScan HT IVD User manual

This manual is also suitable for

Roche iScan HT IVD User manual

Related papers

Other documents