Roche BenchMark GX User manual

BenchMark and BenchMark GX Operator Manual

Ventana Medical Systems, Inc.

www.ventanamed.com

BenchMark and BenchMark GX Operator Manual

Copyright

be copied, reproduced, or distributed by any means or for any purpose without the express prior written

Ventana Medical Systems, Inc.

Trademark

BENCHMARK, NEXES, DISCOVERY, SLS, INFORM, VENTANA, and the Ventana Logo are trademarks

of Roche. All other trademarks are the property of their respective owners.

Licenses

Ventana’s products may be governed by one or more license agreements, including third-party licenses.

Users of the products or software discussed in this operator manual, including NexES Software Version 10.6,

and other Ventana products are subject to the terms of such licenses. Other products, components, modules,

features and/or functions referenced in this operator manual that are not part of the BenchMark base products

or package of products discussed herein may not be received or used by any person unless the relevant license

fees are paid and the relevant license agreements are duly executed.

Disclaimer and Waiver of Warranty

Ventana makes no warranty of any kind with regard to the material contained in this operator manual,

including but not limited to, the implied warranties of merchantability and fitness for a particular purpose.

Receipt or use of the products discussed herein are subject to the product warranty, statement of intended use,

and other regulatory information, if any, contained in this manual.

This publication is furnished “as is” and is for informational use only and should not be construed as a

commitment of any kind by Ventana. Every effort has been made to ensure that the information contained in

this operator manual is accurate as of the time of printing. However, Ventana shall not be liable for errors or

omissions contained in this operator manual or for any damages, including incidental or consequential damages,

in connection with the furnishing, performance, or use of the material in this operator manual.

Information in this operator manual is subject to change without notice. Ventana reserves the right to make

any changes to this operator manual as necessary as part of ongoing product development. Users should

check the latest version of this operator manual for any updates or additions to the information herein.

Governing Law

All copyrights, trademarks, patents, and license agreements shall be governed and construed in accordance

with the laws of the State of Arizona and the laws of the United States, unless otherwise provided in

agreements governing such copyrights, trademarks, patents, or licenses.

Contact

Ventana Medical Systems, Inc.

1910 E. Innovation Park Drive

Tucson, Arizona 85755

USA

+1 520 887 2155

+1 800 227 2155 (USA)

www.ventanamed.com

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

BenchMark and BenchMark GX Operator Manual 2010-08-04 20656EN Rev K

BenchMark and BenchMark GX Operator Manual 20656EN Rev K i

Compliance with Standards

The BenchMark instrument is manufactured and certified to comply with the following safety standards:

EN 61010-1 Safety requirements for electrical equipment for measurement, control, and

laboratory use – Part 1: General requirements

EN 61010-2-081 Safety requirements for electrical equipment for measurement, control, and

laboratory use – Part 2-081: Particular requirements for automatic and semi-

automatic laboratory equipment for analysis and other purposes

EN 61010-2-101 Safety requirements for electrical equipment for measurement, control, and

laboratory use – Part 2-101: Particular requirements for in vitro diagnostic

(IVD) medical equipment

EN 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC

requirements – Part 2-6: Particular requirements - In vitro diagnostic (IVD)

medical equipment; IEC 61326-2-6:2005

IEC 61010-2-010 Safety Requirements for Electrical Equipment for Measurement, Control, and

Laboratory Use, Part 2-010: Particular Requirements for Laboratory Equipment

for the Heating of Materials

IEC/EN 60825-1 Ed. 2:2007 Safety of laser products - Part 1: Equipment classification and

requirements.

Federal Communications Commission (FCC) Information

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to

Part 15 of the FCC rules. These limits are designed to provide reasonable protection against interference

when the equipment is operated in a commercial environment. This equipment generates, uses, and can

radiate radio frequency energy, and if not installed and used in accordance with the instruction manual, may

cause interference to radio communications. Operation of this equipment in a residential area is likely to

cause interference, in which case the user will be required to correct the interference at his own expense.

However, there is no guarantee that interference will not occur in a particular installation. If this equipment

does cause interference to radio or television reception, which can be determined by turning the equipment

off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver.

• Connect the equipment into an outlet on a different circuit from that into which the receiver is

connected.

• Consult the dealer or an experienced radio/TV technician for help.

CAUTION: CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED BY THE PARTY

RESPONSIBLE FOR COMPLIANCE WITH PART 15 OF THE FCC RULES COULD VOID THE

USER’S AUTHORITY TO OPERATE THE EQUIPMENT.

Canadian Department of Communications (DOC) Information

This digital apparatus does not exceed the Class A limits for radio noise emissions from digital apparatuses as

set out in the Radio Frequency Regulations of the DOC.

ii Regulatory Notices

INTENTIONALLY BLANK

BenchMark and BenchMark GX Operator Manual 20656EN Rev K iii

INSTRUMENT SPECIFICATIONS

Physical

Characteristics:

Staining Module (SM) Automated Fluidics

Module (AFM)

Base Cabinet Module

Size (W x D x H): 16.25” x 22” x 13.75”

(41.3 x 55.9 x 34.9 cm)

20” x 21.5” x 15.25”

(50.8 x 54.6 x 38.7 cm)

20” x 21.5” x 38”

(50.8 x 54.6 x 96.5 cm)

with drawer and AFM

Weight 55 lbs (25 kg) 58 lbs (26.4 kg) empty 40 lbs (18.2 kg)

without AFM

Clearances Top 15” (38.1 cm)

Sides 4” (10.2cm)

Rear 6” (15.2 cm)

Top 0.0” (0.0 cm)

Sides 4” (10.2cm)

Rear 6” (15.2 cm)

SM Electrical

Characteristics:

BenchMark (750-800), BenchMark GX (750-850)

Voltage

100-120 / 200-230 VAC

Current

4 / 2 Amps

Frequency

50 / 60 Hz

Power Connection Cord suited to country. For U.S., standard 3-prong grounded.

Fuse 6.3 Amps, 250 Volts, 5 x 20 mm, fast-acting.

AFM Electrical Characteristics:

BenchMark

BenchMark GX

AFM 750-801*

AFM 750-851*

AFM 750-821*

AFM 750-871**

AFM 750-811*

AFM 750-861*

Voltage ~120 VAC ~100 VAC ~230 VAC

Current 4 Amps 4 Amps*, 2 Amps** 2 Amps

Frequency 60 Hz. 50/60 Hz. 50/60 Hz.

Power Connection Cord suited to country. For U.S., standard 3-prong grounded.

Fuse * 6.3 Amps, 250 Volts, 5 x 20 mm, fast-acting.

**2.0 Amps, 250 Volts, 5 x 20 mm, time lag.

Environmental Requirements:

BTU/Hr Output 1200 BTU/Hr

Room Temperature 15°C to 30°C (59°F to 86°F) {Note: The instrument may be unable to maintain

proper reaction temperature if laboratory ambient temperature exceeds the

specified maximum temperature.}

Humidity 10% to 90%, non-condensing

Location Flat, level surface. No direct sunlight or drafts. Remove from sources of direct

heat and moisture. Maximum altitude 2000m. For indoor use only. Do not

position the instrument so that it is difficult to remove the main plug from the

power outlet.

Temperature Control:

Slide Heater Pad

Temperature Range

37°C to 95°C ±2.0°C

General Characteristics:

Capability IHC, ISH, and FITC slide processing

Slide Carousel 1-20 slides with independent temperature control for each position.

Reagent Carousel 25 reagent positions

Slides 25 x 75 mm, 1 x 3 inches or 26 x 76 mm Superfrost Plus

Modularity 1-8 BenchMark systems may be controlled from one computer system.

Water Quality NCCLS Type II water or equivalent (referred to as deionized water).

Bulk Reagents Up to seven different bulk reagents in 3- to 6-liter on-board containers.

Configurations Floor mounted using waste module with 20-liter waste bottle, or bench mounted

with 20-liter waste bottle.

Certifications CSA, CE

Figure 1. System Setup Diagram

The power strip that accompanies the staining system should not be placed on the floor. Electrical hazard

may occur if this power strip comes into contact with liquid. This power strip should be used to connect the

computer components only in a dry environment.

iv Instrument Specifications

Transportation and Storage

Transporting and storing the instrument is performed under the same conditions as stated in the Instrument

Specifications.

Relocating the Instrument

Relocating the instrument should be performed only by Ventana personnel.

Installing the Instrument

Installation of the instrument should be performed only by Ventana personnel or its representatives.

IEC Installation Category

BenchMark belongs in IEC Installation Category II, which is defined as local level, special equipment or

parts of equipment, telecommunications, electronic, etc, with smaller transient voltages than Installation

Category III.

Parts Supplied by Ventana

Fuses are supplied and installed by Ventana.

User-Replaceable Fuses

No fuses are user-replaceable.

Disposal at End of Useful Life

At the end of its useful life, this equipment must be disposed of in accordance with local and/or national

environmental requirements.

Symbols

For In Vitro Diagnostic Use

Catalog Number

Serial Number

CE Mark

Mark of conformity to electrical safety standards issued by Canadian Standards

Association (CSA)

Lot Number

Keep Out Of Direct Sunlight

Temperature Limitations

BenchMark and BenchMark GX Operator Manual 20656EN Rev K v

Single Use Only

Expiration Date

Caution, consult accompanying documents

Laser

Hot Surface

Electric Shock

Electric Shock Hazard

Disconnect Power

Slip Hazard

Biological Risk

Pinch Hazard

Protective Earth

vi Instrument Specifications

BenchMark and BenchMark GX Operator Manual 20656EN Rev K vii

Preface

The BenchMark system has hardware, software, and reagent components. This manual covers operation,

safety information, and maintenance of the BenchMark and BenchMark GX systems. Any features or

instructions that apply only to the BenchMark GX system are noted in the manual. Details for each reagent

product are covered in their respective package inserts.

First, you are given a quick review of the components of a BenchMark system, focused on the hardware. The

section “Basic Instrument Operation,” covers virtually all of the hands-on information you need to operate a

BenchMark instrument on a daily basis.

In “Preventive Maintenance” we cover periodic requirements for cleaning, disinfecting, and system checks.

The maintenance chores are very important, and you should read, understand, and follow these directions

faithfully.

Intended Use

The BenchMark system is intended to automatically stain histological or cytological specimens on

microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic

use.

The system is intended to be run by trained laboratory personnel, such as histotechnologists and laboratory

technicians, who are expert in histology processes and have basic computer operation skills. The system is

intended to be installed in an anatomical laboratory environment, either clinical or research, and must be used

in a manner consistent with industry practices for safety, security, regulatory, environmental, ergonomic,

workflow and information technology.

viii Preface

INTENTIONALLY BLANK

BenchMark and BenchMark GX Operator Manual 20656EN Rev K ix

TABLE OF CONTENTS

Compliance with Standards.......................................................................i

Federal Communications Commission (FCC) Information.....................i

Canadian Department of Communications (DOC) Information ..............i

Instrument Specifications........................................................................iii

Transportation and Storage................................................................v

Relocating the Instrument...................................................................v

Installing the Instrument......................................................................v

IEC Installation Category....................................................................v

Parts Supplied by Ventana .................................................................v

User-Replaceable Fuses ....................................................................v

Disposal at End of Useful Life.............................................................v

Symbols ............................................................................................v

Preface.......................................................................................................ix

Intended Use..............................................................................................ix

1.0 HOW BENCHMARK WORKS............................................................1

Instrument Function............................................................................1

Carousel and Bar Codes.........................................................2

Dual Rinse Station...................................................................3

Jet Drain Station......................................................................3

Multispense Station.................................................................4

LCS Dispense Station.............................................................5

Air Knife Station.......................................................................5

ThermoClean Dispense Station ..............................................6

Mixing Stations........................................................................7

Temperature Control...............................................................8

Importance of Leveling............................................................8

2.0 SAFETY INFORMATION ...................................................................9

Stainer Subassembly..........................................................................9

Warning Labels...................................................................................9

x Table of Contents

Caution: Hot Surface—Do Not Touch....................................9

Caution: Refer to Accompanying Documents ......................10

Caution: Risk of Electric Shock............................................10

Caution: Shock Hazard - Do not Expose to Water (ISO 3864)10

Caution: Disconnect Power Before Servicing.......................11

Caution: Laser on Board ......................................................11

Caution: Biological Risk........................................................12

Caution: Pinch Hazard .........................................................12

Warning: Slip Hazard (ISO 3864/ANSIZ535.4).....................12

Safety Training......................................................................13

Safety Compliance................................................................13

3.0 BENCHMARK COMPONENTS........................................................15

BenchMark Modules.........................................................................16

The Staining Module..............................................................16

The Automated Fluidics Module (AFM).................................17

Priming the System...........................................................................17

The Waste Module................................................................18

The Computer .......................................................................18

NexES Software ...............................................................................19

4.0 BASIC INSTRUMENT OPERATION................................................21

Slides ..........................................................................................21

What is a Run? .................................................................................21

Hardware ..........................................................................................21

Turning on the Instrument.....................................................21

Instrument Control Panel.......................................................21

Opening Slide Doors.............................................................22

Operator Actions before a Run..............................................23

Mounting Slides in the Carousel............................................23

Initialization before a Run......................................................25

Removable Reagent Tray .....................................................26

Registration Wand for Kits and Ventana Products............................27

Cleaning BenchMark ........................................................................28

Manual Applications..........................................................................28

Automatic and Manual Backup..............................................29

Software ..........................................................................................29

Starting a Run .......................................................................29

BenchMark and BenchMark GX Operator Manual 20656EN Rev K xi

Pre-Run Checklist.........................................................30

Reading Bar Codes...............................................................30

Duplicate Product Usage.......................................................32

Exiting the Program...............................................................35

During a Run.........................................................................35

Monitoring Run Progress.......................................................36

Viewing Run Times ...............................................................36

When Something Goes Wrong..............................................37

Signing Off Messages...........................................................38

Stopping a Run......................................................................38

Post-Run Reports..................................................................39

Print Report (Run Summary).................................................41

Print Extended (Full Run Report)..........................................43

5.0 BULK FLUIDS..................................................................................45

Refill Bulk Bottles (BenchMark GX Instrument )...............................45

Remove a BenchMark GX Instrument Bulk Bottle ................45

Install a BenchMark GX Instrument Bulk Bottle ....................45

Refill Bulk Bottles (BenchMark Instrument) ......................................46

Remove a BenchMark Instrument Bulk Bottle.......................46

Install a BenchMark Instrument Bulk Bottle...........................46

EZ Prep (Position 1)..........................................................................46

LCS (Position 2)................................................................................47

SSC (Position 3) (only for ISH applications).....................................47

Reaction Buffer (Position 4)..............................................................47

CC1 (Position 5) ...............................................................................48

CC2 (Position 6) ...............................................................................48

Optional (Position 7) .........................................................................48

Instructions for Installing and Maintaining Spigots............................48

6.0 Registering and Logging Reagents ..............................................53

Ventana Reagents and Refillable Dispensers ..................................53

Customer-Supplied Products............................................................53

Logging Customer-Supplied Antibodies............................................54

Log New Antibody Tab..........................................................56

QC Notice......................................................................56

Expiration and Received Dates.............................................57

xii Table of Contents

Multiple Suppliers for the Same Antibody .............................57

Log Antibody Tab..................................................................57

Viewing and Deactivating Antibodies....................................58

Logging Other Customer-Supplied Reagents...................................60

Log New Reagents Tab....................................................................61

QC Notice..............................................................................61

Expiration and Received Dates.............................................62

Multiple Suppliers for the Same Reagent..............................62

Log Reagents Tab.................................................................62

Viewing and Deactivating Reagents......................................63

Filling the Dispenser with the Reagent..................................65

Filling an Empty (Never-Used) Dispenser.............................66

Emptying and Refilling a Dispenser ......................................68

Refilling a Partially Filled Dispenser......................................70

7.0 PROTOCOL EDITING AND PRINTING...........................................73

Using the Protocol Editor..................................................................73

Editing an Existing Protocol...................................................73

Creating a New Protocol .......................................................75

Automating Your ISH Protocol..........................................................76

General Information...............................................................77

Bulk Solutions........................................................................77

Slide Volume.........................................................................77

Deleting a Protocol ...........................................................................77

Converting a Protocol .......................................................................78

Titration ..........................................................................................80

Reviewing the Steps in a Protocol....................................................80

Creating a Protocol Report....................................................82

Printing a Protocol Report.....................................................82

Viewing a Protocol.................................................................83

Printing a Protocol Usage Report .....................................................83

8.0 NAMES AND PASSWORDS............................................................87

Login and Sign-Off Passwords and Name........................................87

Using Names without Passwords .....................................................88

Administrator.....................................................................................88

About Privileges ....................................................................88

The Most Important Privileges...............................................89

BenchMark and BenchMark GX Operator Manual 20656EN Rev K xiii

Entering and Changing Names and Passwords...............................89

To Remove a User................................................................90

Disabling or Enabling Passwords..........................................91

Login Timeout........................................................................92

9.0 SYSTEM SETUP AND MAINTENANCE..........................................93

Setup Staining Modules....................................................................93

Setup Host........................................................................................96

Host Options Tab ..................................................................96

Institution Tab........................................................................97

Security Tab..........................................................................97

Slide Data Tab.......................................................................98

Stainer Options Tab ..............................................................98

VLM Options Tab—for Optimal Connectivity Solutions.........99

SLS Options Tab.................................................................106

Keycodes ............................................................................106

Staining Module Code Download....................................................108

Archive NexES System Data..........................................................110

Freshening the Backup...................................................................112

About NexES Screen......................................................................112

Print Contact Report............................................................114

Service Functions, the TESTS Button ............................................117

Protected Procedures..........................................................117

10.0 SYSTEM MAP................................................................................119

Functions by Button........................................................................119

Functions by Use............................................................................121

11.0 PREVENTIVE MAINTENANCE......................................................125

Download Tests..............................................................................125

Opening the Upper Chassis............................................................127

Homing the Carousels ....................................................................127

Homing the Reagent Carousel............................................127

Function ......................................................................127

Use..............................................................................127

Homing the Slide Carousel..................................................128

Function ......................................................................128

xiv Table of Contents

Use..............................................................................128

Jog Reagent Carousel.........................................................129

Function ......................................................................129

Use..............................................................................129

Jog Slide Carousel..............................................................130

Function ......................................................................130

Use..............................................................................130

Vortex Mixer Test................................................................131

Function ......................................................................131

Use..............................................................................131

Barcode Blowoff Test..........................................................133

Function ......................................................................133

Use..............................................................................133

Using Daily, Monthly, and Quarterly Checklists..............................134

Viewing Maintenance History..............................................135

Logging Periodic Maintenance Tasks .................................138

Daily Checklist ................................................................................143

Wipe External Surfaces.......................................................143

Pre-Run Checklist ...............................................................144

Monthly Checklist............................................................................145

Rinse Each Bulk Fluid Container.........................................145

Level Instrument..................................................................146

Wash and Brush Slide Heater Pads....................................147

Wash and Brush Nozzles....................................................147

Clean Bar Code Reader Mirror....................................148

Clean Waste Drain..............................................................149

Clean Bulk Solution Bottle Inlet Filters................................149

Quarterly Checklist .........................................................................150

Run Temperature Verifiers..................................................150

Run Scandisk (Older Systems)...........................................151

Run Scandisk (Newer Systems)..........................................152

Defragment Hard Drive (Older Systems) ............................152

Defragment Hard Drive (Newer Systems)...........................154

Decontaminate Instrument..................................................157

BenchMark and BenchMark GX Operator Manual 20656EN Rev K xv

Decontaminate Bulk Carboys..............................................158

Decontaminate Bulk Fluid Bottles .......................................159

12.0 THE EBAR PRINTER.....................................................................163

Slide Labeling System Basics.........................................................163

Label Printing and Templates..............................................163

Customizing Printing ...........................................................163

The Labels......................................................................................163

Tearing off Labels................................................................164

Applying a Label to a Slide..................................................164

Label Do’s and Don’ts.........................................................164

Printer Components........................................................................165

Buttons and Indicators.........................................................166

Setup ........................................................................................167

Setting Up the Printer..........................................................167

Loading Label and Tag Stock..............................................167

Label Supply Roll Spindle...............................................................168

Ribbon Loading Instructions ...........................................................169

Using The Ebar Printer ...................................................................171

Power-on Utilities ................................................................171

Self Test Utility ....................................................................171

Gap Sensor Calibration Utility.............................................172

Printer Initialization..............................................................172

Printer Error Messages .......................................................172

Troubleshooting Guide ...................................................................173

Mylar Shield Information......................................................173

Using The Ebar II Printer ................................................................174

Loading the Ebar II Label Roll.............................................175

Loading the Ebar II Ribbon..................................................177

Setting up the Ebar II Printer...............................................179

Ebar II Printer Maintenance.................................................180

Ebar II Printer Operation and Troubleshooting....................181

SLS Software..................................................................................182

Starting and Exiting SLS .....................................................182

The Main Screen.................................................................182

Printing a Test Label ...........................................................183

Anatomy of a Label .............................................................185

xvi Table of Contents

Printing with Pauses for Input..............................................185

Exiting the Program.............................................................186

Printing Labels with SLS.................................................................186

Before You Print..................................................................186

Previewing a Label..............................................................188

Removing a Label ...............................................................189

Adding a Label ....................................................................190

Starting Fresh......................................................................190

Selecting History Labels .................................................................190

Caution for Laboratories with Multiple Systems..................191

Start Printing...................................................................................192

Entering Prompted Information ...........................................193

Monitoring Print Quality.......................................................194

If Something Goes Wrong While Printing............................195

Running out of Labels .........................................................195

Missing Label on a Roll.......................................................196

Running out of Ribbon.........................................................197

13.0 SLS TEMPLATES: DESIGNING YOUR OWN LAYOUT...............199

What Is a Template?.......................................................................199

Using Extra Lines on the Label ...........................................199

Entering Information as You Print .......................................199

Designing Labels with a Template ......................................199

Creating or Modifying a Template.......................................200

Template Fields...................................................................202

Edit Button and Field Properties..........................................203

Fixed Text ...................................................................206

Text.............................................................................206

List...............................................................................209

Date.............................................................................216

Mask............................................................................216

14.0 ERROR MESSAGES......................................................................223

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Roche BenchMark GX User manual

Roche BenchMark GX User manual

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