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BenchMark GX

Roche BenchMark GX User manual

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BenchMark and BenchMark GX Operator Manual
BenchMark and BenchMark GX Operator Manual
Ventana Medical Systems, Inc.
www.ventanamed.com
BenchMark and BenchMark GX Operator Manual
Copyright
© 2003-2010 Ventana Medical Systems, Inc. All Rights Reserved. No portion of this operator manual may
be copied, reproduced, or distributed by any means or for any purpose without the express prior written
permission of Ventana Medical Systems, Inc. (Ventana). NexES Software Version 10.6, © 1996-2009
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
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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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