Roche BenchMark ULTRA User manual

Type
User manual
Ventana Medical Systems, Inc.
www.ventana.com
Part No.: 750-600
November 2012, 24814EN Rev E
BenchMark ULTRA
Advanced Staining System
Operator Guide
ii BenchMark ULTRA Advanced Staining System
BenchMark ULTRA Advanced Staining System Operator Guide
Copyright © 2012. Ventana Medical Systems, Inc.
All rights reserved.
BENCHMARK, NEXES, DISCOVERY, SLS, VENTANA, and the VENTANA logo are trademarks of Roche.
All other trademarks are the property of their respective owners.
The Ventana System Software (VSS) 12.1 is protected by contract law, copyright laws, and international treaties.
The Ventana System Software (VSS) 12.1 is licensed for use between Ventana Medical Systems, Inc.and a licensee, and only users authorized
there under are permitted to access and use the software. Unauthorized use and distribution may result in civil and criminal penalties.
Warranty
Ventana warrants and represents that when used per instructions, the Products will perform in accordance with the relevant Product specification
for a period of 12 months from the date of delivery or installation of system or instrument. Reagents are warranted until their respective expiry
dates. Ventana reserves the right to change the design or specifications of the Products at any time. Ventana will provide Customer prior notice
of any change in design or specification that materially affects Product performance. Ventana further warrants that the Products do not infringe
the patent rights of third parties. In the event of a court order of patent infringement results in an interruption in the Customer's continued use of
the Products, Ventana shall, at its option, either (a) ) provide for the Customer at Ventana's expense the right to continue using the affected
products; or (b) ) modify or replace the affected products so that the products become non-infringing, but only if the modification or replacement
does not negatively affect the performance of the products or their use by the Customer. THE FOREGOING WARRANTY IS IN LIEU OF ALL
OTHER WARRANTIES. VENTANA DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ALL WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE., Ventana will have no liability for any claim of infringement to
the extent that it is based on materials or modifications made by Customer or a third party at the request of Customer. This Section 4 states the
entire liability of Ventana and the exclusive remedy of Customer with respect to any alleged infringement. Ventana's warranty obligations are
contingent upon Customer: (i) ) notifying Ventana of a warranty claim within ten (10) days after having knowledge of same; (ii) ) providing
sufficient detail of the facts associated with a warranty claim in writing so as to allow Ventana to reasonably reproduce any alleged defects in the
Products, or demonstrate to Ventana such defect.
Contact
Ventana Medical Systems, Inc.
a Member of the Roche Group
1910 Innovation Park Drive
Tucson, AZ 85755
USA
+1 520 887-2155
+1 800 227-2155 (USA)
www.ventana.com
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
Revision History
Manual Version Revision date Changes
12.1 November 2012 Updated instructions for cleaning waste tub and drain.
Regulatory Notices, removed reference to clinical or research in Intended Purpose section.
Chapter 7, clarified that after a staining run completes, slide specific information is listed
on the Run Report or Case Report.
24814EN Rev E iii
Contents
List of Figures ........................................................................................... xvii
Regulatory Notices .....................................................................................xxv
Compliance with Standards ..................................................................................... xxv
Intended Use ........................................................................................................... xxvi
Intended Purpose .................................................................................................... xxvi
FCC Information ...................................................................................................... xxvi
Canadian DOC Information ..................................................................................... xxvi
Specifications ......................................................................................................... xxvii
Disposal at End of Useful Life ................................................................................xxviii
Chapter 1. Welcome .......................................................................................1
Description .................................................................................................................. 1
System Capabilities ..................................................................................................... 2
Staining Capabilities ............................................................................................... 2
Operating Capabilities ............................................................................................ 2
Staining Management ................................................................................................. 2
IHC ......................................................................................................................... 2
ISH .......................................................................................................................... 2
Dual Stains ............................................................................................................. 2
Integration into Your Workflow .................................................................................... 2
Connectivity ............................................................................................................ 2
Vantage Compatibility ............................................................................................. 3
Chapter 2. Warnings and Precautions ............................................................5
Safety Compliance ...................................................................................................... 5
Avoiding Injury ............................................................................................................. 5
Biological and Chemical Hazards ........................................................................... 5
Spills ....................................................................................................................... 5
Cleaning and Maintenance ..................................................................................... 6
Instrument Location ................................................................................................ 6
Safety Training ....................................................................................................... 6
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Contents BenchMark ULTRA Advanced Staining System Operator Guide
Electrical Hazards .................................................................................................. 6
Stainer Subassembly Operation ............................................................................. 7
Symbols ...................................................................................................................... 8
Chapter 3. The BenchMark ULTRA System .............................................. 11
Theory and Principles of Instrument Operation ......................................................... 11
System Components ................................................................................................. 11
Staining Instrument .............................................................................................. 11
Computer .............................................................................................................. 11
Product Registration Probe .................................................................................. 12
Label and Report Printers .................................................................................... 12
USB Flash Disk .................................................................................................... 12
Products ............................................................................................................... 12
How the System Works ............................................................................................. 13
Starting a Staining Run ........................................................................................ 13
Monitoring a Run .................................................................................................. 13
Continuous Access Processing ............................................................................ 13
Bulk Fluids and Waste ..................................................................................... 13
Ultimate Reagent Access Feature ................................................................... 14
Staining Slides ...................................................................................................... 14
The BenchMark ULTRA Instrument .......................................................................... 14
Reagent Hood ...................................................................................................... 14
Reagent Carousel ................................................................................................ 14
Slide Drawers ....................................................................................................... 15
Instrument Status Panel ....................................................................................... 15
Bulk Reagents ...................................................................................................... 15
Waste Containers ................................................................................................. 15
The Ventana System Software ................................................................................. 16
System Information and Software Version Control ................................................... 16
Global Navigation ................................................................................................. 16
Instrument Bar ...................................................................................................... 16
Communicator ...................................................................................................... 16
Home View ........................................................................................................... 17
Instrument View .................................................................................................... 17
Reagent and Slide Histograms ............................................................................. 19
Inventory and Orders ............................................................................................ 20
Steps to Staining Slides ............................................................................................ 20
Chapter 4. Perform a Staining Run .............................................................. 21
Start Up ..................................................................................................................... 21
Refill Bulk Bottles ...................................................................................................... 21
Remove or Replace a Bulk Bottle ........................................................................ 21
Empty Waste Containers .......................................................................................... 21
Create Labels ............................................................................................................ 22
Apply Slide Labels ..................................................................................................... 23
Print a Pick List of Required Reagents ..................................................................... 24
Install a Reagent Tray ............................................................................................... 25
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24814EN Rev E v
Load Slides ............................................................................................................... 25
Start the Staining Run ............................................................................................... 26
Unload Completed Slides .......................................................................................... 26
Rinse Slides and Apply Coverslips ........................................................................... 26
Chapter 5. Start and Stop the System ...........................................................27
About Starting and Stopping ..................................................................................... 27
Start the Ventana System Software ........................................................................ 27
Start an Instrument .................................................................................................... 28
Startup Modes ...................................................................................................... 29
Stop an Instrument .................................................................................................... 29
Shut Down the Software and Computer .................................................................... 30
Chapter 6. Operate the Staining Instrument .................................................31
Instrument Parts ........................................................................................................ 31
Connect and Define Instruments ............................................................................... 32
Monitor Instrument Status ......................................................................................... 33
Instrument Status Panel ....................................................................................... 33
Software Status Indicators .................................................................................... 33
About Startup Modes ................................................................................................ 34
Sleep Mode .......................................................................................................... 34
Ready Mode ......................................................................................................... 34
Running Mode ...................................................................................................... 34
Processing Slides ............................................................................................ 34
Adding Slides While Running .......................................................................... 35
When Slides Are Finished ............................................................................... 35
Start and Stop an Instrument .................................................................................... 36
Start an Instrument .............................................................................................. 36
Stop an Instrument ............................................................................................... 36
Open the Reagent Hood ........................................................................................... 36
Operate Slide Drawers .............................................................................................. 37
On the Instrument ................................................................................................. 37
Single Drawers ................................................................................................ 37
Groups of Drawers ........................................................................................... 37
On the Computer .................................................................................................. 37
Selected Drawers ............................................................................................ 37
Groups of Drawers ........................................................................................... 38
Add Slides While Slides Are Running ....................................................................... 38
Add a Single Slide ................................................................................................ 38
Add a Group of Slides .......................................................................................... 38
Cancel Slides ............................................................................................................ 39
Find a Slide on an Instrument ................................................................................... 39
Reagent Access Points ............................................................................................. 39
About Reagent Access Points .............................................................................. 39
When a Reagent Access Point is Reached .......................................................... 40
View Status of Reagent Access Points ................................................................ 40
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Contents BenchMark ULTRA Advanced Staining System Operator Guide
Reagent Access and Reagent Qualification ......................................................... 40
Schedule Reagent Access Points From the Instrument View .............................. 41
Select a Reagent Access Time ....................................................................... 41
View the Selected Reagent Access Time and the Reagent Pick List .............. 42
Schedule Reagent Access Points From Slide and Reagent Histogram Views .... 42
About Histogram Blue Bands ...................................................................... 43
Histogram Reagent Access Buttons ................................................................ 44
Select Reagent Access Point in a Histogram .................................................. 44
Information and Error Messages .......................................................................... 44
Maintenance .............................................................................................................. 45
Maintenance Check List ....................................................................................... 45
Daily Maintenance ................................................................................................ 45
Wipe External Surfaces ................................................................................... 45
Pre-Run Check List .......................................................................................... 45
Clean Slide Drawers ........................................................................................ 45
Monthly and Quarterly Maintenance .................................................................... 46
Chapter 7. Manage Slide Orders ................................................................. 47
About the Order List .................................................................................................. 47
Order List .............................................................................................................. 47
Orders Sent from an LIS ...................................................................................... 48
How Orders Are Organized .................................................................................. 48
Organize the Order List ............................................................................................. 49
Column Options .................................................................................................... 49
Move or Resize Columns ..................................................................................... 49
Sort Column Up or Down ..................................................................................... 50
Return to Default Settings .................................................................................... 50
Custom Filters ...................................................................................................... 50
Order Maintenance ............................................................................................... 51
Find Orders ............................................................................................................... 51
Find Orders by Requester .................................................................................... 51
Sort Orders by Printed Labels .............................................................................. 51
Sort Orders by Slide ID ........................................................................................ 51
Sort Orders by Status and Protocol ...................................................................... 51
Group Orders by Label ......................................................................................... 52
Print Orders ............................................................................................................... 52
Find Slides on the Instrument ................................................................................... 52
View Order Details .................................................................................................... 53
Create a New Order .................................................................................................. 53
Change Order Information ....................................................................................... 54
Create Multiple Orders .............................................................................................. 54
Order List View ..................................................................................................... 55
Order Details View ............................................................................................... 55
Select Protocol View ............................................................................................ 56
Create Multiple New Orders for a Patient ............................................................. 57
Re-create an Order .............................................................................................. 58
Edit an Order ........................................................................................................ 58
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Delete an Order ......................................................................................................... 58
Print Reports and Labels ........................................................................................... 59
Print an Order Report ........................................................................................... 59
Print or Reprint Slide Labels ................................................................................. 59
Print a Reagent Pick List ...................................................................................... 60
Chapter 8. Create Staining Protocols ...........................................................61
About Staining Protocols ........................................................................................... 61
Instrument Protocols Option ...................................................................................... 61
Search, View, and Print Features in the Protocol Editor ........................................... 62
Selectable Protocol Options ................................................................................. 63
Protocol Views ...................................................................................................... 63
To use the pop-up selection window ............................................................. 64
To use the sidebar view instead of the pop up window ................................... 65
How to Search Protocol Steps by Keyword .......................................................... 66
How to Print from the Protocol Editor ................................................................... 66
How to Use the Zoom Feature ............................................................................. 67
How to Scroll with the Mouse Wheel .................................................................... 67
Create and Print a Protocol ....................................................................................... 68
Modify a Protocol ...................................................................................................... 69
Delete a Protocol ....................................................................................................... 70
View Protocol Definitions .......................................................................................... 70
Print Protocol Steps and Details ............................................................................... 70
Print a Protocol Usage Report .................................................................................. 71
Chapter 9. Generate Slide Labels .................................................................73
About Slide Labels .................................................................................................... 73
Label Handling .......................................................................................................... 74
Create a Slide Label .................................................................................................. 74
Create a Batch of Slide Labels .................................................................................. 76
Print a Batch of Slide Labels ..................................................................................... 76
Remove a Label from the Print List ........................................................................... 76
Cancel Slide Label Printing ....................................................................................... 77
Apply a Slide Label ................................................................................................... 77
Reprint Slide Labels .................................................................................................. 78
Print Labels from the Order List ................................................................................ 79
Print Labels from the Order Details Panel ................................................................. 79
Change Label Information ......................................................................................... 79
Change Case Protocol Selection .......................................................................... 79
Chapter 10. Work with Slides ......................................................................81
About Slides .............................................................................................................. 81
Load and Remove Slides .......................................................................................... 81
Load a Slide into a Drawer ................................................................................... 81
Remove a Slide from a Drawer ............................................................................ 81
viii Ventana Medical Systems A Member of the Roche Group
Contents BenchMark ULTRA Advanced Staining System Operator Guide
Cancel a Slide ...................................................................................................... 82
Monitor Slides ........................................................................................................... 82
Instrument Bar Status ........................................................................................... 82
Slide Details ......................................................................................................... 83
Slide Processing Time .......................................................................................... 85
Find Slides on an Instrument .................................................................................... 86
Create Slide Reports ................................................................................................. 87
Print Run Reports ................................................................................................. 87
Protocol Steps in the Stopped Run Report .......................................................... 88
Edit Slide Data ...................................................................................................... 89
Design a New Case Report .................................................................................. 89
Print a Case Report .............................................................................................. 90
Delete a Case Report ........................................................................................... 90
Modify a Case Report ........................................................................................... 91
Consolidated Run Reports ................................................................................... 91
Print Consolidated Run Reports ........................................................................... 91
Chapter 11. Manage Reagents ..................................................................... 93
About Reagents ........................................................................................................ 93
Status Indicators ................................................................................................... 93
Dispensers ........................................................................................................... 93
Duplicate Products ............................................................................................... 93
Pick Lists .............................................................................................................. 93
Manage Reagents with Ultimate Reagent Access ............................................... 94
About Ultimate Reagent Access Hardware .................................................... 94
Set User Privileges for Ultimate Reagent Access ............................................ 95
Set Pre-Reagent Access Alarm Warning ......................................................... 95
When a Reagent Access Point is Reached ..................................................... 95
Load a Dispenser onto a Tray .................................................................................. 96
Install and Remove Trays ......................................................................................... 97
Install a Tray ......................................................................................................... 97
Remove a Tray ..................................................................................................... 97
Monitor Reagents ...................................................................................................... 98
Check Reagent Status ......................................................................................... 98
View Details in Instrument View ........................................................................... 98
View Details in the Histogram .............................................................................. 99
View and Print the Reagent Grid ............................................................................. 100
Sorting Reagent Grid Columns .......................................................................... 102
View a Reagent Access Pick List ............................................................................ 102
View Last Reagents ................................................................................................ 103
View Last Reagents in the Histogram ................................................................ 103
View Last Reagents in a Run Report ................................................................. 103
Register a VENTANA Reagent ............................................................................... 103
Register a Non-Ventana Reagent ........................................................................... 104
Manage Reagent Inventory ..................................................................................... 104
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Chapter 12. Titrating ..................................................................................105
About Titration ......................................................................................................... 105
Create a Titration Protocol ...................................................................................... 106
Run Titration Slides ................................................................................................. 107
Manual Applications List ......................................................................................... 108
Apply Reagent to a Slide ......................................................................................... 109
Unload Titration Slides ............................................................................................ 109
Print a Run Report .................................................................................................. 109
Chapter 13. Prepare Bulk Products ............................................................111
About Bulk Products ................................................................................................ 111
Remove or Replace a Bulk Bottle ........................................................................... 111
Prepare Bulk Reagents ........................................................................................... 111
Position 1: EZ Prep ............................................................................................. 111
Position 2: ULTRA Liquid Coverslip ................................................................... 112
Position 3: SSC .................................................................................................. 112
Position 4: Reaction Buffer ................................................................................. 112
Position 5: ULTRA CC1 ...................................................................................... 113
Position 6: ULTRA CC2 ...................................................................................... 113
Position 7: Optional ............................................................................................ 113
Manage Waste Containers ...................................................................................... 113
Monitor Waste Containers .................................................................................. 113
Set Waste Container Levels ............................................................................... 114
Empty and Replace a Waste Container ............................................................. 115
Install a Carboy Spigot ....................................................................................... 115
Chapter 14. Quality Control .......................................................................117
About Control Slides ............................................................................................... 117
Managing Blocks and Control Slides ...................................................................... 117
Record Control Block Information ....................................................................... 118
Log Control Slides .............................................................................................. 119
View Control Block Information .......................................................................... 120
View a Series of Control Slides .......................................................................... 120
Deactivate a Control Block ................................................................................. 120
Deactivate a Series of Control Slides ................................................................. 121
Enter a Request for Control Slides ..................................................................... 121
View Control Slide Requests .............................................................................. 122
Deactivate a Requester Record ......................................................................... 122
Deactivate Control Slide Requests ..................................................................... 122
Enter Control Results .............................................................................................. 123
Select a Staining Run ......................................................................................... 123
Enter and Print Results ....................................................................................... 123
Quality Control Reports ........................................................................................... 125
Print a Quality Control Report ............................................................................. 125
x Ventana Medical Systems A Member of the Roche Group
Contents BenchMark ULTRA Advanced Staining System Operator Guide
Chapter 15. Reports ................................................................................... 127
Case Report ............................................................................................................ 127
Contact Reports ...................................................................................................... 127
Contact List ........................................................................................................ 128
Contact Form ...................................................................................................... 128
Daily Maintenance Log ............................................................................................ 128
Inventory Reports .................................................................................................... 129
Inventory Report ................................................................................................. 129
Inventory Product Usage .................................................................................... 129
Inventory Detail Usage Report for Dispensers .................................................. 130
Inventory Detail Usage Report for Vials ............................................................ 130
Inventory Detail Usage Report for Bulks ........................................................... 131
Reagent Access Point Pick List .............................................................................. 132
Manual Application List ........................................................................................... 132
Order List Reports ................................................................................................... 132
Order Grid .......................................................................................................... 132
Pick List for Selected Orders .............................................................................. 133
Protocol Reports ..................................................................................................... 133
Protocol Report .................................................................................................. 133
Protocol Summary Report .................................................................................. 133
Protocol Usage Report ....................................................................................... 134
Quality Control Reports ........................................................................................... 134
Case Control Report ........................................................................................... 134
Antibody QC Report ........................................................................................... 134
Probe QC Report ................................................................................................ 135
Dispensed Reagent QC Report .......................................................................... 135
Kit QC Report ..................................................................................................... 135
Bulk QC Report .................................................................................................. 136
Control Block QC Report .................................................................................... 136
Slide Series QC Report ...................................................................................... 136
Staining Run Reports .............................................................................................. 137
Run Report Messages and Reagent Access ..................................................... 137
Completed Staining Run Report ......................................................................... 138
Stopped Staining Run Report ............................................................................. 138
Consolidated Completed Staining Run Report .................................................. 139
Print Preview ........................................................................................................... 140
Chapter 16. Label Printer .......................................................................... 141
About the Printer ..................................................................................................... 141
Set Up the Printer .................................................................................................... 141
Load a Label Roll .................................................................................................... 142
Load a Ribbon ......................................................................................................... 143
Update SLS for New Label Roll or Ribbon .............................................................. 143
Clean the Printer ..................................................................................................... 144
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Chapter 17. Messages and Errors ...............................................................145
About the Communicator ........................................................................................ 145
Manage Messages .................................................................................................. 146
Sign off on a Critical Error .................................................................................. 146
Add Comments for a Critical Error ...................................................................... 146
If a Fatal Error Occurs ........................................................................................ 146
Message Classes ................................................................................................... 147
HASP Key .......................................................................................................... 148
Product Registration .......................................................................................... 149
Communication with the Instrument .................................................................. 150
Serial Numbers .................................................................................................. 152
Software Application .......................................................................................... 153
Run Compilation ................................................................................................ 156
Database ........................................................................................................... 167
Database Access ............................................................................................... 170
Reagent Database .............................................................................................. 171
Printing .............................................................................................................. 171
Communication Port .......................................................................................... 172
Remote Software ............................................................................................... 172
Instrument Tray Scan ........................................................................................ 187
Staining Run ...................................................................................................... 189
Reagent Access Point ....................................................................................... 191
Database Table Repair ...................................................................................... 192
Ultimate Reagent Access ................................................................................... 193
Reagent Access Points and Adding New Slides ........................................... 193
Reagent Access Points and Manual Reagent Application ............................. 193
Expired, Exhausted, Ownership, Registration, Duplication Issues .............. 193
Missing Reagents – New Slides ................................................................... 194
Missing Reagents – Processing Slides ......................................................... 194
Reagent Positioning ..................................................................................... 195
Chapter 18. Manage Inventory ...................................................................197
About Inventory Management ................................................................................. 197
How It Works ...................................................................................................... 197
Reagents ............................................................................................................ 197
Bulk Fluids .......................................................................................................... 198
Products from Ventana ....................................................................................... 198
One-Touch Registration ................................................................................. 198
Reagent Dispensers ...................................................................................... 198
Products from Other Suppliers ........................................................................... 199
The Inventory List .................................................................................................... 200
View Product Details ............................................................................................... 201
In the Inventory List ............................................................................................ 201
In View Registered Products .............................................................................. 202
Organize the Inventory List ..................................................................................... 203
Move Columns .................................................................................................... 203
Sort Product Records ......................................................................................... 203
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Contents BenchMark ULTRA Advanced Staining System Operator Guide
Sort Using Column Headings ........................................................................ 203
Sort Using Column Options ........................................................................... 203
Group Products .................................................................................................. 204
Flag Items for Notification ................................................................................... 205
Retrieve Inventory Warnings .............................................................................. 206
Hide Kit Components ......................................................................................... 206
Custom Filter ...................................................................................................... 207
Print Inventory Reports ....................................................................................... 208
Print a Custom Report ........................................................................................ 208
Save a Custom Report ....................................................................................... 209
Open a Saved Report ......................................................................................... 209
Print a Detail Usage Report ................................................................................ 209
About the Dispenser, Vial, and Bulk Report Options ..................................... 209
About Error Messages ................................................................................... 209
To print a Detail Usage Report ...................................................................... 209
Print a Product Usage Report ............................................................................ 210
Print a Bulk Product Usage Report ................................................................... 211
Associate Bulk Products with Instruments .............................................................. 212
Register Ventana Products ..................................................................................... 213
Register Non-Ventana Products ............................................................................. 214
Log Products ...................................................................................................... 214
Log Fillable Antibodies ................................................................................... 215
Log Fillable Probes ........................................................................................ 217
Log Fillable Reagents .................................................................................... 218
Fill a Ventana Dispenser .................................................................................... 219
Fill a New Dispenser ...................................................................................... 219
Empty and Refill a Used Dispenser ............................................................... 220
Top Off a Partly Filled Dispenser ................................................................... 222
Deactivate Products ................................................................................................ 223
Reactivate Products ................................................................................................ 223
Chapter 19. Set Up the System .................................................................. 225
About Setup ............................................................................................................ 225
Slide Data Fields ................................................................................................ 225
Keycodes ............................................................................................................ 225
Reagent Access Permission and Login Passwords Enabled ............................. 225
Set Up the Host ....................................................................................................... 226
Enter Address for Report Headings ........................................................................ 227
Find Hardware Serial Numbers ............................................................................... 227
Set Up Passwords and Log-ins ............................................................................... 228
Define Slide Data Fields .......................................................................................... 229
Set End of Run Signal and Pre-Reagent Access Point Alarm ................................ 229
Set Up VLM Collaboration .................................................................................. 229
Open VLM Options ............................................................................................. 230
Specify VLM Options .......................................................................................... 230
Activate Keycode Slide Labeling ........................................................................ 231
Specify SLS Options ............................................................................................... 232
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Update SLS for a New Label Roll or Ribbon ........................................................... 233
Cancel Setup Changes ........................................................................................... 233
Restore the Default Setup ....................................................................................... 233
Set Up User Accounts ............................................................................................. 233
About User Names and Passwords .................................................................... 233
The Administrator Account ............................................................................ 233
Passwords ..................................................................................................... 234
System Privileges .......................................................................................... 234
User Groups .................................................................................................. 234
Add a User Name and Password ....................................................................... 234
Change a User Name and Password ................................................................. 235
Delete a User Name and Password ................................................................... 236
Add a User Group ............................................................................................... 236
Change a User Group ........................................................................................ 236
Delete a User Group ........................................................................................... 237
Look Up User Names or Groups ........................................................................ 237
Manage Contacts .................................................................................................... 237
View or Change Contact Information .................................................................. 237
Add a Contact ..................................................................................................... 238
Delete a Contact ................................................................................................. 238
Print Contact Information .................................................................................... 238
Print a List of Contacts ....................................................................................... 239
Chapter 20. Cleaning and Maintenance .....................................................241
About Cleaning and Maintenance ........................................................................... 241
Go to Instrument Maintenance ........................................................................... 241
Go to Maintenance ............................................................................................. 242
Maintenance Check List .......................................................................................... 242
Print User Maintenance Logs .................................................................................. 243
Record Completed Maintenance ............................................................................. 243
About Decontamination Tasks ............................................................................ 244
View or Add Maintenance Notes ........................................................................ 244
Daily Maintenance ................................................................................................... 244
Wipe External Surfaces ...................................................................................... 244
Disinfect Waste Containers ................................................................................ 245
Clean Slide Drawers ........................................................................................... 245
Using the Clean Icon .......................................................................................... 246
Clean Icon Status .......................................................................................... 246
Starting a Cleaning Cycle Using the Clean Icon ............................................ 246
Aborting a Cleaning Cycle ............................................................................. 247
Weekly Maintenance ............................................................................................... 247
Back Up the Database ........................................................................................ 247
Run Database Maintenance ............................................................................... 248
Monthly Maintenance .............................................................................................. 248
Rinse Bulk Fluid Containers ............................................................................... 248
Wash and Brush Slide Heating Pads ................................................................. 248
Clean Waste Tub and Drain ............................................................................... 249
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Contents BenchMark ULTRA Advanced Staining System Operator Guide
Quarterly Maintenance ............................................................................................ 249
Run Slide Heater Temperature Verifiers ............................................................ 249
Decontaminate Bulk Fluid Bottles ...................................................................... 250
Decontaminate Bulk Fluid Reservoirs ................................................................ 250
Decontamination Alert ................................................................................... 250
How Decontamination Works ........................................................................ 250
Two Decontamination Methods ..................................................................... 251
If You Need to Stop Decontamination ........................................................... 251
What You Need for Decontamination ............................................................ 252
Decontamination Record ............................................................................... 253
Prepare the Instrument for Decontamination ..................................................... 253
Decontaminate Reservoirs Using Tubing ........................................................... 254
Decontaminate Reservoirs Using Bottles ........................................................... 256
Database Management ........................................................................................... 259
How the System Archives Data .......................................................................... 259
Archive System Data .......................................................................................... 260
View the Archive Data ................................................................................... 262
Defragment the Hard Disk ....................................................................................... 262
Preventive Maintenance .......................................................................................... 263
About Preventive Maintenance .......................................................................... 263
Schedule Preventive Maintenance ..................................................................... 263
Chapter 21. Customization ........................................................................ 265
Label Templates ...................................................................................................... 265
Create a New Label Template ................................................................................ 266
Set the Font Size ................................................................................................ 266
Select the Field and Line Dimensions ................................................................ 266
Open the Field Properties View .......................................................................... 266
Design Fixed Prompt Fields ........................................................................... 267
Design Text Entry Fields ................................................................................ 267
Specify a List of Options ................................................................................ 268
Add a Date ..................................................................................................... 269
Add a Number or Letter to Labels ...................................................................... 270
Increment Numerically ................................................................................... 270
Increment Alphabetically ................................................................................ 271
Customize a Date Format .............................................................................. 273
Set the Default Template ........................................................................................ 273
Modify a Label Template ......................................................................................... 274
Delete a Label Template ......................................................................................... 274
Chapter 22. Connectivity ........................................................................... 275
LIS Connectivity ...................................................................................................... 275
Central Management ............................................................................................... 275
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Chapter 23. Troubleshooting ......................................................................277
Run Function Tests ................................................................................................. 277
Go to the Function Test List ............................................................................... 277
Home and Jog the Nozzle Plate ......................................................................... 277
Home and Jog the Reagent Carousel ................................................................ 278
Chapter A. Ventana Laboratory Manager ..................................................279
About the Ventana Laboratory Manager ................................................................. 279
Set Up VLM ............................................................................................................. 279
Monitor Connections ............................................................................................... 280
Monitor Data Elements ............................................................................................ 280
View VLM Events .................................................................................................... 281
Chapter B. Ventana Interface Point ............................................................283
About the Ventana Interface Point Software ........................................................... 283
Set Up Interface Options ......................................................................................... 283
Map Fields ............................................................................................................... 285
Field Mapper Buttons ......................................................................................... 286
Example: Map HL7 Code to Patient ID Field ...................................................... 287
View Case Result ............................................................................................... 289
View Protocols ........................................................................................................ 289
View Case Slides .................................................................................................... 289
Create a New Connection To a Client or Server. .................................................... 290
Open the Connection Options ............................................................................ 290
Add a Client Connection ..................................................................................... 290
Add a New Server Connection ........................................................................... 292
View Data Elements ........................................................................................... 293
View the Event Log ................................................................................................. 293
xvi Ventana Medical Systems A Member of the Roche Group
Contents BenchMark ULTRA Advanced Staining System Operator Guide
24814EN Rev E xvii
List of Figures
Figure 1. Safety Symbols ................................................................................................. 9
Figure 2. Host System Components and Staining Instrument ....................................... 11
Figure 3. Product Registration ....................................................................................... 12
Figure 4. Printer and Label ............................................................................................ 12
Figure 5. Reagent Carousel and Dispensers .................................................................. 14
Figure 6. Independent Slide Drawers ............................................................................ 15
Figure 7. Bulk Reagent Dispensers ............................................................................... 15
Figure 8. Waste Containers ............................................................................................ 15
Figure 9. Software System Information ......................................................................... 16
Figure 10. Global Navigation ......................................................................................... 16
Figure 11. Instrument Bar ............................................................................................... 16
Figure 12. Communicator ............................................................................................... 17
Figure 13. Home View .................................................................................................... 17
Figure 14. Instrument View ............................................................................................ 18
Figure 15. Slide Histogram ............................................................................................. 19
Figure 16. Inventory List ................................................................................................ 20
Figure 17. Instrument View Ready Button ..................................................................... 21
Figure 18. Bulk Bottle Connectors ................................................................................. 21
Figure 19. Waste Container Lock ................................................................................... 22
Figure 20. Select Slide Labels Options ........................................................................... 22
Figure 21. Print a Slide Label ......................................................................................... 23
Figure 22. Apply a Label ................................................................................................ 23
Figure 23. Orders Icon .................................................................................................... 24
Figure 24. Order List ....................................................................................................... 24
Figure 25. Print Pick List ................................................................................................ 24
Figure 26. Pick List in Print Preview .............................................................................. 24
Figure 27. Dispensers in Tray ......................................................................................... 25
Figure 28. Tray Mounting ............................................................................................... 25
Figure 29. Slide Control Panel ........................................................................................ 25
Figure 30. Seat a Slide .................................................................................................... 25
Figure 31. Run Time ....................................................................................................... 26
Figure 32. VENTANA logo Shortcut Icon ..................................................................... 27
Figure 33. Splash Screen ................................................................................................. 27
xviii Ventana Medical Systems A Member of the Roche Group
List of Figures BenchMark ULTRA Advanced Staining System Operator Guide
Figure 34. Software at Startup .........................................................................................28
Figure 35. Instrument On-Off Switch ..............................................................................28
Figure 36. Ready Button ..................................................................................................28
Figure 37. Instrument Bar in Running Mode ...................................................................29
Figure 38. BenchMark ULTRA Instrument .....................................................................31
Figure 39. Instrument Setup Button in the Home View ..................................................32
Figure 40. Instrument Setup View ...................................................................................32
Figure 41. Instrument Status Panel ..................................................................................33
Figure 42. Instrument Bar Indicators ...............................................................................33
Figure 43. Startup Modes .................................................................................................34
Figure 44. On-Off Switch ................................................................................................36
Figure 45. Drawer Button ................................................................................................37
Figure 46. Instrument Slide Control Panel ......................................................................37
Figure 47. Operate Selected Drawers ..............................................................................37
Figure 48. Software Slide Control Panel .........................................................................38
Figure 49. Abort Selected Slides .....................................................................................39
Figure 50. Icon Bar with Reagent Access Shortcut icon .................................................41
Figure 51. Reagent Access Shortcut Icon with Reagent Access Times ..........................41
Figure 52. Selected Reagent Access Shortcut Icon with Reagent Pick List ....................42
Figure 53. Setting Reagent Access Points from the Slide Histogram View ..................43
Figure 54. Selected Reagent Access Point from Reagent Histogram View
with Reagent Pick List ...................................................................................43
Figure 55. Order List Features .........................................................................................47
Figure 56. Orders Received from LIS ..............................................................................48
Figure 57. Order Data ......................................................................................................48
Figure 58. Filter Buttons ..................................................................................................50
Figure 59. Filter Builder ..................................................................................................50
Figure 60. Retrieve a Custom Filter .................................................................................51
Figure 61. Orders Grouped by Label ...............................................................................52
Figure 62. Order Details ..................................................................................................53
Figure 63. Re-create Option .............................................................................................55
Figure 64. Order Details ..................................................................................................55
Figure 65. Select Protocol ................................................................................................56
Figure 66. Re-create Order ..............................................................................................58
Figure 67. Order Grid Print Preview ................................................................................59
Figure 68. Pick List of Reagents ......................................................................................60
Figure 69. List Protocols by Instrument Type .................................................................61
Figure 70. New Protocol Editor View ............................................................................62
Figure 71. New Selectable Protocol Options .................................................................63
Figure 72. Pop up View of Protocol Selection ...............................................................64
Figure 73. Pop up View with Find Feature ......................................................................64
Figure 74. Sidebar View of Protocol Selections ..............................................................65
Figure 75. Protocol Quick Find in Protocol Editor ..........................................................65
BenchMark ULTRA Advanced Staining System Operator Guide List of Figures
24814EN Rev E xix
Figure 76. Protocol Keyword Find Feature ................................................................... 66
Figure 77. Print Protocol from the Protocol Editor ......................................................... 67
Figure 78. Protocol Editor with Zoom Feature ............................................................... 67
Figure 79. Create a Protocol ........................................................................................... 68
Figure 80. Type Protocol Number .................................................................................. 68
Figure 81. Protocol Report Options ................................................................................ 69
Figure 82. View Protocols .............................................................................................. 70
Figure 83. Set Up a Protocol Report ............................................................................... 70
Figure 84. Print a Protocol Usage Report ....................................................................... 71
Figure 85. Slide Label Components ................................................................................ 73
Figure 86. Create Slide Label ........................................................................................ 74
Figure 87. Enter Slide Label Text ................................................................................... 75
Figure 88. Apply a Slide Label ....................................................................................... 77
Figure 89. Reprint Slide Labels ...................................................................................... 78
Figure 90. Slide Seated in Drawer .................................................................................. 81
Figure 91. Remove a Slide .............................................................................................. 81
Figure 92. Abort Selected Slides .................................................................................... 82
Figure 93. Instrument Bar Status Indicator ..................................................................... 82
Figure 94. Slide Information Pop-up Box ....................................................................... 83
Figure 95. Order Details-Slide Details ............................................................................ 83
Figure 96. Order Details—Slide Protocol ....................................................................... 84
Figure 97. Processing Time on the Slide Histogram ...................................................... 85
Figure 98. Turn On Drawer Lights ................................................................................. 86
Figure 99. Blue Light on Drawer .................................................................................... 86
Figure 100. Print Run Reports ........................................................................................ 87
Figure 101. Completed Run Report ................................................................................ 88
Figure 102. Protocol Steps in a Completed Run Report ................................................. 88
Figure 103. Protocol Steps in Stopped Run Report ........................................................ 88
Figure 104. Edit Slide Data ............................................................................................. 89
Figure 105. Case Reports ................................................................................................ 89
Figure 106. Print a Consolidated Run Report with User-Defined Options .................... 91
Figure 107. Consolidated Completed Run Report .......................................................... 92
Figure 108. Reagent Detect Sensor .............................................................................. 94
Figure 109. Reagent Carousel Hardware ...................................................................... 94
Figure 110. Reagent Dispensers ..................................................................................... 96
Figure 111. Reagent Tray and Holder ............................................................................. 97
Figure 112. Tray Mounting Holes and Carousel Studs ................................................... 97
Figure 113. Status Indicators .......................................................................................... 98
Figure 114. Reagent Information Pop-up Box ................................................................ 98
Figure 115. Product Details ............................................................................................ 99
Figure 116. Reagent Histogram ...................................................................................... 99
Figure 117. Instrument View with Reagent Grid Icon ................................................. 100
xx Ventana Medical Systems A Member of the Roche Group
List of Figures BenchMark ULTRA Advanced Staining System Operator Guide
Figure 118. Instrument View displaying the Reagent Grid with Zoom control,
Reagent Wheel, and Print icon ...................................................................101
Figure 119. Reagent Histogram View with Reagent Grid View Enabled .....................101
Figure 120. Reagent Grid and Multiple Column Sorting ..............................................102
Figure 121. Selected Reagent Access Point at Shortcut Icon with Reagent Pick List ...102
Figure 122. Report for Last Staining Run ......................................................................103
Figure 123. View Last Reagents ....................................................................................103
Figure 124. Register Ventana Products .........................................................................104
Figure 125. Product Registration Probe .........................................................................104
Figure 126. New Product in the Inventory List .............................................................104
Figure 127. Titration Information ..................................................................................105
Figure 128. Create a Titration Protocol .........................................................................106
Figure 129. Add a Titration Step to a Protocol ..............................................................106
Figure 130. Save Protocol ..............................................................................................106
Figure 131. Manual Applications Icon ..........................................................................108
Figure 132. Manual Applications List. ..........................................................................108
Figure 133. Titration Message in Communicator ..........................................................109
Figure 134. Select a Titer Run .......................................................................................109
Figure 135. Bulk Bottle Connectors ..............................................................................111
Figure 136. Waste Level Monitor ..................................................................................113
Figure 137. Set Maximum Waste Level ........................................................................114
Figure 138. Waste Container Lock ................................................................................115
Figure 139. Carboy, Spigot, and Threaded Connector ..................................................115
Figure 140. Spigot and Locknut .....................................................................................116
Figure 141. Spigot Handle Positions .............................................................................116
Figure 142. Control Block Information .........................................................................118
Figure 143. Log Control Slides ......................................................................................119
Figure 144. View Control Block Information ................................................................120
Figure 145. View a Series of Control Slides ..................................................................120
Figure 146. Enter a Case Request ..................................................................................121
Figure 147. List of Cases ...............................................................................................122
Figure 148. Cases Ordered .............................................................................................122
Figure 149. Select a Staining Run ..................................................................................123
Figure 150. Enter Quality Control Results ....................................................................123
Figure 151. Print Quality Control Results .....................................................................124
Figure 152. Quality Control Report ...............................................................................125
Figure 153. Case Report ................................................................................................127
Figure 154. Contact List ................................................................................................128
Figure 155. Contact Form ..............................................................................................128
Figure 156. Daily Maintenance Log ..............................................................................128
Figure 157. Inventory Report .........................................................................................129
Figure 158. Inventory Product Usage ............................................................................129
Figure 159. Detail Usage Report for Dispensers ...........................................................130
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Roche BenchMark ULTRA User manual

Type
User manual

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