Hologic thinprep 2000

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MAN-02624-001 Rev. 003 page 1 of 15

Instructions For Use

Main Page

Intended Use6
Summary and Explanation of the System6
The Thinprep Sample Preparation Process6
Limitations7
Warnings8
Precautions8
Performance Characteristics9
Laboratory and Patient Characteristics9
Clinical Study Results10
Site Characteristics10
Diagnostic Classification Table, All Categories10
Two Category Diagnostic Classification Table, ASCUS/AGUS and more Severe Diagnoses11
Two Category Diagnostic Classification Table, LSIL and more Severe Diagnoses11
Three Category Diagnostic Classification Table11
Results by Site, LSIL and more Severe Lesions12
Results by Site, ASCUS/AGUS and more Severe Lesions12
Independent Pathologist Results by Site, LSIL and more Severe Lesions13
Independent Pathologist Results by Site, ASCUS/AGUS and more Severe Lesions13
Summary of Descriptive Diagnosis14
Benign Cellular Changes Results14
Summary of Specimen Adequacy Results15
Specimen Adequacy Results15
Specimen Adequacy Results by Site16
Specimen Adequacy Results by Site, SBLB Rates for no Endocervical Component16
Direct-To-Vial Endocervical Component (ECC) Studies16
Summary of Direct-To-Vial HSIL+ Study17
Direct-To-Vial HSIL+ Study17
Summary of Direct-To-Vial Endocervical Component (ECC) Studies17
Conclusions18
Materials Required18
Storage19
Bibliography19
Technical Service and Product Information19
Table of Contents23
Introduction28
Overview and Function of the Thinprep 2000 System28
Indication for Use28
The Thinprep 2000 Processor and Waste Bottle29
Materials Provided32
Materials Required but Not Provided33
Principles of Operation34
Sample Preparation/Instrument Loading35
Start of Cycle35
Fluid Level Detection35
Dispersion35
Filter Wetting36
Cell Collection36
Waste Clearing37
Bubble Point37
Cell Transfer37
Cycle Completion37
Overview of Processing38
Thinprep 2000 System Components39
Thinprep 2000 System Technical Specifications39
Overview of Components39
Processor Dimensions40
Processor Clearances40
Thinprep 2000 Dimensions and Clearances40
Dimensions and Weight (Approximate)41
Environmental41
Power41
RS-232 Connection42
Thinprep 2000 Standards42
Power on Self Test (POST)43
Warnings, Cautions and Notes43
Thinprep 2000 Hazards43
Internal Quality Control43
Location of Labels Used on the Instrument45
Disposal46
Warnings Used in this Manual46
Disposal of the Equipment47
Thinprep 2000 Installation51
General51
Action Upon Delivery51
Preparation Prior to Installation52
Internal Packaging Removal52
Location Selection Information52
Removing the Rotating Plate Packaging54
Removing the Slide Handler Packaging55
Connecting the Waste Bottle56
Waste Tubing Connections56
Inserting the Program Memory Card57
Connecting the Power Cord58
Turning on Your Thinprep 2000 Processor59
Run a Blank Sample61
Storage and Handling - Post Installation62
Turning off the Thinprep 2000 Processor62
Turning the Instrument off62
Taking the Instrument out of Service (Extended Shutdown)62
Preservcyt Solution64
Storage Requirements65
Composition65
Packaging65
Transportation66
Aligning the Vial Cap66
Stability66
Handling/Disposal66
Interfering Substances67
Thinprep® Solutions Storage Guide68
Hologic Shipping Recommendations69
Gynecologic Sample Preparation76
Collection Preparation77
Thinprep Collection Techniques77
Patient Information77
Specimen Collection Preparation77
Collect Gynecologic Sample Using the Broom-Like Device78
Collect Gynecologic Sample, Using the Endocervical Brush/Spatula Device79
Special Precautions80
Preservcyt Sample Vial Fluid Level81
Run on Thinprep 2000 Processor Using Sequence 4, Fix, Stain, and Evaluate82
Sample Processing Troubleshooting82
Reprocessing Protocol83
Operating Instructions87
Optional Instructions for Ancillary Testing88
Material Requirements90
Pre-Operation Checklist91
Overview of Loading the Thinprep 2000 Processor92
Thinprep 2000 Processor Loaded with Supplies92
Loading the Preservcyt Sample Vial93
Loading the Thinprep Pap Test Filter94
Assembling the Filter Cap and Filter94
Correct Filter Cap-To-Filter Assembly95
Positioning the Filter Cap in the Bobbins95
Loading the Filter Assembly96
Loading the Thinprep Microscope Slide97
Inserting the Slide Onto the Clamps97
Correct/Incorrect Slide Insertion98
Inserting the Slide Fully99
Loading the Fixative Vial100
Door Opening and Closing101
Selecting and Initiating a Sequence102
Thinprep 2000 Processor Sequences and Modes103
Unloading the Thinprep 2000 Processor104
Capping the Preservcyt Sample Vial105
Interrupting the Slide Preparation Process106
Status, Maintenance, and Test Screens107
Pnemautic Testing112
Operating Instructions for Processing COBAS AMPLICOR™ CT/NG Samples113
Preparing the Filter Caps118
Put on Clean Laboratory Gloves118
Removing the Filter Assembly132
Instrument Troubleshooting140
How to Use this Section141
Table of Contents142
Close Door to Continue Processing143
Close Door to Continue Processing144
Insert Fix Bath to Continue Processing145
Insert Slide to Continue Processing147
Remove Filter149
Remove Fix Bath151
Remove Slide153
Remove Fix Bath to Continue Processing155
Remove Slide to Continue Processing157
Sample Is Dilute159
Evacuation Failure. Check Filter161
Filter Already Wet163
No Fluid Detected. Check Filter and Vial165
Sample too Dense. Dilute 20:1167
Vial too Full. 21 Ml Max. Allowed169
Waste System Failure171
Door Open While Processing Sample173
Press ENTER with Door Closed to Retry Initialization. System Uninitialized174
Stop Key Pressed175
Error History176
- Maintenance179
- Opening/Closing the Waste Bottle180
- SECTION B: Emptying Waste Bottle180
- SECTION C: Filter Cap Cleaning182
- SECTION D: Filter Cap O-Ring Lubrication183
- SECTION E: Filter Seal O-Ring Replacement184
- Opening Door for Cleaning185
- SECTION F: Door Cleaning185
- SECTION G: Cap Seal Cleaning186
- SECTION H: General Cleaning187
- SECTION I: Waste Tubing Replacement188
  - Waste Filter Replacement192
  - Emptying and Cleaning the Catch Tray194
  - Place the Catch Tray into the Cabinet. Fit Screws into the Tray Indents194
  - Re-Insert the Catch Tray194
  - Moving the Thinprep 2000 Processor195
  - Unit Moved Within Building195
  - Unit Shipped to New Location195
  - Maintenance Schedule196
  - Fixation, Staining, and Coverslipping200
  - Fixation201
  - Staining202
  - Staining Protocol202
  - Hologic Staining Protocol204
  - Coverslipping205
  - References205
  - Design207
  - Objective207
  - Thinprep Pap Test Training Program207
  - Cytology Staff Training208
  - Index210
  - Non-Gynecologic Sample Preparation220
- SECTION D: Details of Non-Gynecologic Sample Preparation Steps223
- SECTION D-1: Collection224
  - Concentrate by Centrifugation - 600G for 10 Minutes227
  - Measuring the Centrifuge227
  - Determining the Correct Centrifuge Speed228
  - Pour off Supplementant and Vortex to Resuspend Cell Pellet229
  - Pouring off Supernatant229
- SECTION D-4: Evaluate Cell Pellet Appearance230
  - Add Specimen to Preservcyt Solution Vial231
  - Factors to Consider231
- Preservcyt ® Solution Vial231
- SECTION D-6: Allow to Stand in Preservcyt Solution for 15 Min232
- Run on Thinprep Processor Using Sequence N, Fix, Stain, and Evaluate233
- SECTION D-7: Run on Thinprep233
- SECTION D-8: Mechanical Agitation234
- SECTION D-9: Cytolyt Solution Wash235
- SECTION E: Specimen Preparation Protocols236
- Fine Needle Aspirates (FNA)237
- SECTION E-1: Fine Needle Aspirates237
- SECTION E-2: Mucoid Specimens238
- SECTION E-3: Body Fluids240
- SECTION E-4: Superficial Brushings and Scrapings241
- SECTION E-4: Firstcyte ® Breast Test Specimens242
  - Thinprep Urocyte Specimens243
  - Instructions for Using the Thinprep Urocyte Urine Collection Kit244
- SECTION G: Sample Preparation Troubleshooting246
- Bloody or Proteinaceous Specimens247
- Common Artifacts251
- Techniques Used in Troubleshooting252
- Solutions255
- Cytolyt Solution259
- Service Information272
- Ordering Information275
- Supplies for the Thinprep Pap Test (Gynecologic) Application276
- Supplies for the Thinprep 2000 Processor278
- Supplies and Solutions for Non-Gynecologic Applications279
- Injection Solutions Available from Baxter Healthcare Corporation 1-800-933-0303280

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