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thinprep 2000
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I
NTRODUCTION
ThinPrep 2000 Processor Operator’s Manua
l
1.17
1
Attention, refer to accompanying
documents.
Protective Conductor T
erminal
(internal use only
, not accessible
to operators)
.
W
aste Electrical an
d Electronic
Equipment - contact Holo
gic for
disposal of the instrument.
43
45
Table of Contents
Main Page
Intended Use
6
Summary and Explanation of the System
6
The Thinprep Sample Preparation Process
6
Limitations
7
Warnings
8
Precautions
8
Performance Characteristics
9
Laboratory and Patient Characteristics
9
Clinical Study Results
10
Site Characteristics
10
Diagnostic Classification Table, All Categories
10
Two Category Diagnostic Classification Table, ASCUS/AGUS and more Severe Diagnoses
11
Two Category Diagnostic Classification Table, LSIL and more Severe Diagnoses
11
Three Category Diagnostic Classification Table
11
Results by Site, LSIL and more Severe Lesions
12
Results by Site, ASCUS/AGUS and more Severe Lesions
12
Independent Pathologist Results by Site, LSIL and more Severe Lesions
13
Independent Pathologist Results by Site, ASCUS/AGUS and more Severe Lesions
13
Summary of Descriptive Diagnosis
14
Benign Cellular Changes Results
14
Summary of Specimen Adequacy Results
15
Specimen Adequacy Results
15
Specimen Adequacy Results by Site
16
Specimen Adequacy Results by Site, SBLB Rates for no Endocervical Component
16
Direct-To-Vial Endocervical Component (ECC) Studies
16
Summary of Direct-To-Vial HSIL+ Study
17
Direct-To-Vial HSIL+ Study
17
Summary of Direct-To-Vial Endocervical Component (ECC) Studies
17
Conclusions
18
Materials Required
18
Storage
19
Bibliography
19
Technical Service and Product Information
19
Table of Contents
23
Introduction
28
Overview and Function of the Thinprep 2000 System
28
Indication for Use
28
The Thinprep 2000 Processor and Waste Bottle
29
Materials Provided
32
Materials Required but Not Provided
33
Principles of Operation
34
Sample Preparation/Instrument Loading
35
Start of Cycle
35
Fluid Level Detection
35
Dispersion
35
Filter Wetting
36
Cell Collection
36
Waste Clearing
37
Bubble Point
37
Cell Transfer
37
Cycle Completion
37
Overview of Processing
38
Thinprep 2000 System Components
39
Thinprep 2000 System Technical Specifications
39
Overview of Components
39
Processor Dimensions
40
Processor Clearances
40
Thinprep 2000 Dimensions and Clearances
40
Dimensions and Weight (Approximate)
41
Environmental
41
Power
41
RS-232 Connection
42
Thinprep 2000 Standards
42
Power on Self Test (POST)
43
Warnings, Cautions and Notes
43
Thinprep 2000 Hazards
43
Internal Quality Control
43
Location of Labels Used on the Instrument
45
Disposal
46
Warnings Used in this Manual
46
Disposal of the Equipment
47
Thinprep 2000 Installation
51
General
51
Action Upon Delivery
51
Preparation Prior to Installation
52
Internal Packaging Removal
52
Location Selection Information
52
Removing the Rotating Plate Packaging
54
Removing the Slide Handler Packaging
55
Connecting the Waste Bottle
56
Waste Tubing Connections
56
Inserting the Program Memory Card
57
Connecting the Power Cord
58
Turning on Your Thinprep 2000 Processor
59
Run a Blank Sample
61
Storage and Handling - Post Installation
62
Turning off the Thinprep 2000 Processor
62
Turning the Instrument off
62
Taking the Instrument out of Service (Extended Shutdown)
62
Preservcyt Solution
64
Storage Requirements
65
Composition
65
Packaging
65
Transportation
66
Aligning the Vial Cap
66
Stability
66
Handling/Disposal
66
Interfering Substances
67
Thinprep® Solutions Storage Guide
68
Hologic Shipping Recommendations
69
Gynecologic Sample Preparation
76
Collection Preparation
77
Thinprep Collection Techniques
77
Patient Information
77
Specimen Collection Preparation
77
Collect Gynecologic Sample Using the Broom-Like Device
78
Collect Gynecologic Sample, Using the Endocervical Brush/Spatula Device
79
Special Precautions
80
Preservcyt Sample Vial Fluid Level
81
Run on Thinprep 2000 Processor Using Sequence 4, Fix, Stain, and Evaluate
82
Sample Processing Troubleshooting
82
Reprocessing Protocol
83
Operating Instructions
87
Optional Instructions for Ancillary Testing
88
Material Requirements
90
Pre-Operation Checklist
91
Overview of Loading the Thinprep 2000 Processor
92
Thinprep 2000 Processor Loaded with Supplies
92
Loading the Preservcyt Sample Vial
93
Loading the Thinprep Pap Test Filter
94
Assembling the Filter Cap and Filter
94
Correct Filter Cap-To-Filter Assembly
95
Positioning the Filter Cap in the Bobbins
95
Loading the Filter Assembly
96
Loading the Thinprep Microscope Slide
97
Inserting the Slide Onto the Clamps
97
Correct/Incorrect Slide Insertion
98
Inserting the Slide Fully
99
Loading the Fixative Vial
100
Door Opening and Closing
101
Selecting and Initiating a Sequence
102
Thinprep 2000 Processor Sequences and Modes
103
Unloading the Thinprep 2000 Processor
104
Capping the Preservcyt Sample Vial
105
Interrupting the Slide Preparation Process
106
Status, Maintenance, and Test Screens
107
Pnemautic Testing
112
Operating Instructions for Processing COBAS AMPLICOR™ CT/NG Samples
113
Preparing the Filter Caps
118
Put on Clean Laboratory Gloves
118
Removing the Filter Assembly
132
Instrument Troubleshooting
140
How to Use this Section
141
Table of Contents
142
Close Door to Continue Processing
143
Close Door to Continue Processing
144
Insert Fix Bath to Continue Processing
145
Insert Slide to Continue Processing
147
Remove Filter
149
Remove Fix Bath
151
Remove Slide
153
Remove Fix Bath to Continue Processing
155
Remove Slide to Continue Processing
157
Sample Is Dilute
159
Evacuation Failure. Check Filter
161
Filter Already Wet
163
No Fluid Detected. Check Filter and Vial
165
Sample too Dense. Dilute 20:1
167
Vial too Full. 21 Ml Max. Allowed
169
Waste System Failure
171
Door Open While Processing Sample
173
Press ENTER with Door Closed to Retry Initialization. System Uninitialized
174
Stop Key Pressed
175
Error History
176
Maintenance
179
Opening/Closing the Waste Bottle
180
SECTION B: Emptying Waste Bottle
180
SECTION C: Filter Cap Cleaning
182
SECTION D: Filter Cap O-Ring Lubrication
183
SECTION E: Filter Seal O-Ring Replacement
184
Opening Door for Cleaning
185
SECTION F: Door Cleaning
185
SECTION G: Cap Seal Cleaning
186
SECTION H: General Cleaning
187
SECTION I: Waste Tubing Replacement
188
Waste Filter Replacement
192
Emptying and Cleaning the Catch Tray
194
Place the Catch Tray into the Cabinet. Fit Screws into the Tray Indents
194
Re-Insert the Catch Tray
194
Moving the Thinprep 2000 Processor
195
Unit Moved Within Building
195
Unit Shipped to New Location
195
Maintenance Schedule
196
Fixation, Staining, and Coverslipping
200
Fixation
201
Staining
202
Staining Protocol
202
Hologic Staining Protocol
204
Coverslipping
205
References
205
Design
207
Objective
207
Thinprep Pap Test Training Program
207
Cytology Staff Training
208
Index
210
Non-Gynecologic Sample Preparation
220
SECTION D: Details of Non-Gynecologic Sample Preparation Steps
223
SECTION D-1: Collection
224
Concentrate by Centrifugation - 600G for 10 Minutes
227
Measuring the Centrifuge
227
Determining the Correct Centrifuge Speed
228
Pour off Supplementant and Vortex to Resuspend Cell Pellet
229
Pouring off Supernatant
229
SECTION D-4: Evaluate Cell Pellet Appearance
230
Add Specimen to Preservcyt Solution Vial
231
Factors to Consider
231
Preservcyt ® Solution Vial
231
SECTION D-6: Allow to Stand in Preservcyt Solution for 15 Min
232
Run on Thinprep Processor Using Sequence N, Fix, Stain, and Evaluate
233
SECTION D-7: Run on Thinprep
233
SECTION D-8: Mechanical Agitation
234
SECTION D-9: Cytolyt Solution Wash
235
SECTION E: Specimen Preparation Protocols
236
Fine Needle Aspirates (FNA)
237
SECTION E-1: Fine Needle Aspirates
237
SECTION E-2: Mucoid Specimens
238
SECTION E-3: Body Fluids
240
SECTION E-4: Superficial Brushings and Scrapings
241
SECTION E-4: Firstcyte ® Breast Test Specimens
242
Thinprep Urocyte Specimens
243
Instructions for Using the Thinprep Urocyte Urine Collection Kit
244
SECTION G: Sample Preparation Troubleshooting
246
Bloody or Proteinaceous Specimens
247
Common Artifacts
251
Techniques Used in Troubleshooting
252
Solutions
255
Cytolyt Solution
259
Service Information
272
Ordering Information
275
Supplies for the Thinprep Pap Test (Gynecologic) Application
276
Supplies for the Thinprep 2000 Processor
278
Supplies and Solutions for Non-Gynecologic Applications
279
Injection Solutions Available from Baxter Healthcare Corporation 1-800-933-0303
280
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