Hologic thinprep 2000 Operator's Manual

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ThinPrep

2000 Processor

LABORATORY SOLUTIONS

Operator’s Manual

MAN-02585-001 Rev. 005

ThinPrep® 2000 System Operator’s Manual

HOLOGIC, INC.HOLOGIC (UK) LIMITED 250 CAMPUS DRIVE UNIT 2, LINK 10 NAPIER WAY MARLBOROUGH, MA 01752 USA CRAWLEY, WEST SUSSEX RH10 9RA T

EL: 1-800-442-9892 UNITED KINGDOM

1-508-263-2900 TEL: +44 (0) 1293 522 080

AX: 1-508-229-2795 FAX: +44 (0) 1293 528 010

EB: WWW.HOLOGIC.COM

MAN-02585-001

Caution: Federal law restricts this device to sale by or on the order of a physician, or any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device and are trained and experienced in the use of the ThinPrep 2000 System.

Preparation of microscope slides using the ThinPrep 2000 System should be performed only by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic.

Evaluation of microscope slides produced with the ThinPrep 2000 System should be performed only by cytotechnologists and pathologists who have been trained to evaluate ThinPrep-prepared slides by Hologic or by organizations or individuals designated by Hologic.

© Hologic, Inc., 2014. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or computer language, in any form, or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior written permission of Hologic, 250 Campus Drive, Marlborough, Massachusetts, 01752, United States of America.

Although this guide has been prepared with every precaution to ensure accuracy, Hologic assumes no liability for any errors or omissions, nor for any damages resulting from the application or use of this information.

This product may be covered by one or more U.S. patents identified at http://hologic.com/patentinformation

Hologic, CytoLyt, PreservCyt and ThinPrep are registered trademarks of Hologic, Inc. or its subsidiaries in the United States and/or other countries. All other trademarks are the property of their respective companies.

Caution: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Document number: AW-08263-001 Rev. 004

Instructions for Use

ThinPrep 2000

Instructions for Use

Instructions For Use

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

INTENDED USE

The ThinPrep smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions (Low-grade Squamous Intraepithelial Lesions, High-grade Squamous Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda

System for Reporting Cervical/Vaginal Cytologic Diagnoses

2000 System is intended as a replacement for the conventional method of Pap

SUMMARY AND EXPLANATION OF THE SYSTEM

The ThinPrep process begins with the patient’s gynecologic sample being collected by the clinician using a cervical sampling device which, rather than being smeared on a microscope slide, is immersed and rinsed in a vial filled with 20 ml of PreservCyt The ThinPrep sample vial is then capped, labeled, and sent to a laboratory equipped with a ThinPrep 2000 Processor.

At the laboratory, the PreservCyt sample vial is placed into a ThinPrep 2000 Processor and a gentle dispersion step breaks up blood, mucus, non-diagnostic debris, and thoroughly mixes the cell sample. The cells are then collected on a ThinPrep Pap Test Filter specifically designed to collect diagnostic cells. The ThinPrep 2000 Processor constantly monitors the rate of flow through the ThinPrep Pap Test Filter during the collection process in order to prevent the cellular presentation from being too scant or too dense. A thin layer of cells is then transferred to a glass slide in a 20 mm-diameter circle, and the slide is automatically deposited into a fixative

solution.

The ThinPrep Sample Preparation Process

Solution (PreservCyt).

(1) Dispersion (2) Cell Collection (3) Cell Transfer

The ThinPrep Pap Test Filter rotates within the sample vial, creating currents in the fluid that are strong enough to separate debris and disperse mucus, but gentle enough to have no adverse effect on cell appearance.

A gentle vacuum is created within the ThinPrep Pap Test Filter, which collects cells on the exterior surface of the membrane. Cell collection is controlled by the ThinPrep 2000 Processor’s software that monitors the rate of flow through the ThinPrep Pap Test Filter.

After the cells are collected on the membrane, the ThinPrep Pap Test Filter is inverted and gently pressed against the ThinPrep Microscope Slide. Natural attraction and slight positive air pressure cause the cells to adhere to the ThinPrep Microscope Slide resulting in an even distribution of cells in a defined circular area.

MAN-02624-001 Rev. 003 page 2 of 15

As with conventional Pap smears, slides prepared with the ThinPrep

2000 System are examined in the context of the patient’s clinical history and information provided by other diagnostic procedures such as colposcopy, biopsy, and human papillomavirus (HPV) testing, to determine patient management.

The PreservCyt and transport medium for gynecologic specimens tested with the Cervista Cervista

Solution component of the ThinPrep 2000 System is an alternative collection

HPV HR Test, the

HPV 16/18 Test, the Roche cobas® HPV Test and the Digene Hybrid Capture System HPV DNA. Refer to the respective manufacturer’s package inserts for instructions for using PreservCyt Solution for collection, transport, storage, and preparation of specimens for use in those systems.

The PreservCyt Solution component of the ThinPrep 2000 System is an alternative collection and transport medium for gynecologic specimens tested with the Hologic APTIMA COMBO 2 CT/NG Assays, the Hologic APTIMA

CT Q

Amplified DNA Assay. Refer to the respective manufacturer’s package inserts for

Trichomonas vaginalis Assay, and the BD ProbeTec™

instructions for using PreservCyt Solution for collection, transport, storage, and preparation of specimens for use in those systems.

The PreservCyt Solution component of the ThinPrep 2000 System is also an alternative collection and transport medium for gynecologic specimens tested with the Roche Diagnostics COBAS AMPLICOR

CT/NG assay. Refer to Hologic’s labeling (Document #MAN-02063-

001) for instructions for using PreservCyt Solution for collection, transport, storage, and preparation of specimens and to the Roche Diagnostics COBAS AMPLICOR CT/NG package insert for instructions for use of that system.

LIMITATIONS

 Gyne cologic sa mples col lected fo r preparat ion using the T hinPrep 2 000 System should be

collected using a broom-type or endocervical brush/plastic spatula combination collection devices.

 Preparation of microscope slides using the ThinPrep 2000 System should be performed only

by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic.

 Evaluation of microscope slides produced with the ThinPrep 2000 System should be

performed only by cytotechnologists and pathologists who have been trained to evaluate ThinPrep prepared slides by Hologic or by organizations or individuals designated by Hologic.

 Supplies used in the ThinPrep 2000 System are those designed and supplied by Hologic

specifically for the ThinPrep 2000 System. These include PreservCyt Solution vials, ThinPrep Pap Test Filters, and ThinPrep Microscope Slides. These supplies are required for proper performance of the system and cannot be substituted. Product performance will be compromised if other supplies are used. After use, supplies should be disposed of in accordance with local, state, and federal regulations.

 A ThinPrep Pap Test Filter must be used only once and cannot be reused.  The performance of HPV DNA and CT/NG testing on reprocessed sample vials has not been

evaluated.

MAN-02624-001 Rev. 003 page 3 of 15

WARNINGS

 For In Vitro Diagnostic Use  PreservCyt Solution contains methanol, which is poisonous and may be fatal or cause

blindness if swallowed. Methanol vapor may be harmful. PreservCyt is flammable; keep away from fire, heat, sparks, and flame. Other solutions must not be substituted for PreservCyt Solution. PreservCyt Solution should be stored and disposed of in accordance with local, state, and federal regulations.

 Do not process a cerebral spinal fluid (CSF) specimen or other sample type that is suspected

of possessing prion infectivity (PrPsc) derived from a person with a TSE, such as Creutzfeldt-Jakob disease, on a ThinPrep processor. A TSE-contaminated processor cannot be effectively decontaminated and therefore must be properly disposed of in order to avoid potential harm to users of the processor or service personnel.

PRECAUTIONS

 Specific processing steps must be followed before and during use of the ThinPrep 2000 processor

if planning to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche Diagnostics COBAS AMPLICOR CT/NG test, on the residual specimen after a slide has been prepared using a ThinPrep 2000 processor. Follow the procedures found in Chapter 5B of the ThinPrep 2000 Operator’s Manual.

 This equipment generates, uses and can radiate radio frequency energy, and if not installed and

used in accordance with the Operator’s Manual, may cause interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at his/her own expense.

 PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be stored

between 15

 PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche

Diagnostics COBAS AMPLICOR CT/NG test must be stored between 4 and tested within 6 weeks of collection.

 PreservCyt Solution was challenged with a variety of microbial and viral organisms. The

following table presents the starting concentrations of viable organisms, and the number of viable organisms found after 15 minutes in the PreservCyt Solution. The log reduction of viable organisms is also presented. As with all laboratory procedures, universal precautions should be followed.

(59oF) and 30oC (86oF) and tested within 6 weeks of collection.

C (39oF) and 25oC (77oF)

MAN-02624-001 Rev. 003 page 4 of 15

Organism Initial Concentration

Candida albicans 5.5 x 105 CFU/mL >4.7

Aspergillus niger* 4.8 x 105 CFU/mL 2.7

Escherichia coli 2.8 x 105 CFU/mL >4.4

Staphylococcus aureus 2.3 x 105 CFU/mL >4.4

Pseudomonas aeruginosa 2.5 x 105 CFU/mL

Mycobacterium tuberculosis** 9.4 x 105 CFU/mL 4.9

Rabbitpox virus 6.0 x 106 PFU/mL 5.5***

HIV-1 1.0 x 10

* After 1 hour >4.7 log reduction

** After 1 hour >5.7 log reduction *** Data is for 5 minutes

Log Reduction after

15 min.

>4.4

7.5

TCID50/mL 7.0***

PERFORMANCE CHARACTERISTICS: REPORT OF CLINICAL STUDIES

A prospective multi-center clinical study was conducted to evaluate the performance of the ThinPrep 2000 System in direct comparison to the conventional Pap smear. The objective of the ThinPrep clinical study was to demonstrate that gynecologic specimens prepared using the ThinPrep 2000 System were at least as effective as conventional Pap smears for the detection of atypical cells and cervical cancer or its precursor lesions in a variety of patient populations. In addition, an assessment of specimen adequacy was performed.

The initial clinical study protocol was a blinded, split sample, matched pair study, for which a conventional Pap smear was prepared first, and the remainder of the sample (the portion that normally would have been discarded) was immersed and rinsed into a vial of PreservCyt Solution. At the laboratory, the PreservCyt sample vial was placed into a ThinPrep 2000 Processor and a slide was then prepared from the patient’s sample. ThinPrep and conventional Pap smear slides were examined and diagnosed independently. Reporting forms containing patient history as well as a checklist of all possible categories of The Bethesda System were used to record the results of the screening. A single independent pathologist reviewed all discrepant and positive slides from all sites in a blinded fashion to provide a further objective review of the results.

LABORATORY AND PATIENT CHARACTERISTICS

Cytology laboratories at three screening centers (designated as S1, S2, and S3) and three hospital centers (designated as H1, H2, and H3) participated in the clinical study. The screening centers in the study serve patient populations (screening populations) with rates of abnormality (Low-grade Squamous Intraepithelial Lesion [LSIL] and more severe lesions) similar to the United States average of less than 5%. (hospital populations) characterized by high rates (>10%) of cervical abnormality. Data on race

The hospital centers in the study serve a high risk referral patient population

MAN-02624-001 Rev. 003 page 5 of 15

demographics was obtained for 70% of the patients that participated in the study. The study population consisted of the following race groups: Caucasian (41.2%), Asian (2.3%), Hispanic (9.7%), African American (15.2%), Native American (1.0%) and other groups (0.6%).

Table 1 describes the laboratories and the patient populations.

Table 1: Site Characteristics

Site Type of

Population

S1 Screening 300,000 1,386 18.0 - 84.0 10.6% 8.8% 2.3% S2 Screening 100,000 1,668 18.0 - 60.6 0.3% 10.7% 2.9% S3 Screening 96,000 1,093 18.0 - 48.8 0.0% 7.1% 3.8%

H1 Hospital 35,000 1,046 18.1 - 89.1 8.1% 40.4% 9.9% H2 Hospital 40,000 1,049 18.1 - 84.4 2.1% 18.2% 12.9% H3 Hospital 37,000 981 18.2 - 78.8 11.1% 3 8.2% 24.2%

Laboratory Characteristics Clinical Study Demographics

Patient

Laboratory

Volume -

Smears per

Year

Cases Patient

CLINICAL STUDY RESULTS

The diagnostic categories of The Bethesda System were used as the basis of the comparison between conventional and ThinPrep statistical analyses for all clinical sites are presented in Tables 2 through 11. Cases with incorrect paperwork, patient’s age less than 18 years, cytologically unsatisfactory slides, or patients with a hysterectomy were excluded from this analysis. Few cases of cervical cancer (0.02% represented in the clinical study, as is typical in the United States patient population.

findings from the clinical study. The diagnostic classification data and

Age Range

Post-Meno-

pausal

Abnormal Pap

Smear

Convent.

Prevalence

LSIL+

) were

Table 2: Diagnostic Classification Table, All Categories

ThinPrep NEG ASCUS

AGUS 13 2 3 0 1 0 1 20 LSIL 114 84 0 227 44 0 0 469 HSIL 11 15 0 35 104 2 0 167 SQ CA 0 0 0 0 0 1 0 1 GL CA 0 0 0 0 0 0 0 0 TOTAL 5680 521 8 367 167 3 1 6747

Abbreviations for Diagnoses: NEG = Normal or negative, ASCUS = Atypical Squamous Cells of Undetermined Significance, AGUS = Atypical Glandular Cells of Undetermined Significance, LSIL = Lowgrade Squamous Intraepithelial Lesion, HSIL = High-grade Squamous Intraepithelial Lesion, SQ CA = Squamous Cell Carcinoma, GL CA = Glandular Cell Adenocarcinoma

Conventional

NEG ASCUS AGUS LSIL HSIL SQ CA GL CA TOTAL

5224 295 3 60 11 0 0 5593

318

125 2 45 7 0 0 497

MAN-02624-001 Rev. 003 page 6 of 15

Table 3: Three Category Diagnostic Classification Table

Conventional

NEG ASCUS/AGUS+ LSIL+ TOTAL

ThinPrep NEG

ASCUS/

AGUS+

LSIL+ 125 99 413 637

TOTAL 5680 529 538 6747

5224 298 71 5593

331 132 54 1154

Table 4: Two Category Diagnostic Classification Table, LSIL and More Severe Diagnoses

Conventional

NEG/ASCUS/

AGUS+

ThinPrep NEG/ASCUS/

AGUS+

LSIL+ 224 413 637

TOTAL 6209 538 6747

5985 125 6110

LSIL+ TOTAL

Table 5: Two Category Diagnostic Classification Table, ASCUS/AGUS and More Severe Diagnoses

NEG ASCUS/AGUS+ TOTAL

ThinPrep NEG

ASCUS/

AGUS+

TOTAL 5680 1067 6747

5224 369 5593

456 698 1154

MAN-02624-001 Rev. 003 page 7 of 15

The diagnostic data analysis from the sites is summarized in Table 6 and 7. When the p-value is significant (p <

0.05), the method favored is indicated in the tables.

Table 6: Results by Site, LSIL and More Severe Lesions

Site

Cases ThinPrep

LSIL+

1,336 46 31 48% 0.027 ThinPrep

Convent.

LSIL+

Increased

Detection*

p-Value Method

Favored

S2 S3

H1 H2

*Increased detection = ThinPrep® LSIL+ - Conventional LSIL+ x 100%

Conventional LSIL+

1,563 78 45 73% <0.001 ThipPrep 1,058 67 40 68% <0.001 ThinPrep

971 125 96 30% <0.001 ThinPrep 1,010 111 130 (15%) 0.135 Neither

809 210 196 7% 0.374 Neither

For LSIL and more severe lesions, the diagnostic comparison statistically favored the ThinPrep

method at four sites and was statistically equivalent at

two sites.

Table 7: Results by Site, ASCUS/AGUS and More Severe Lesions

Site

S1 1,336 117 93 26% 0.067 Neither S2 1,563 124 80 55% <0.001 ThinPrep S3 1,058 123 81 52% <0.001 ThinPrep

Cases ThinPrep

ASCUS+

Convent. ASCUS+

Increased

Detection*

p-Value Method

Favored

H1 971 204 173 18% 0.007 ThinPrep H2 1,010 259 282 (8%) 0.360 Neither H3 809 327 359 (9%) 0.102 Neither

*Increased detection = ThinPrep ASCUS+ - Conventional ASCUS+ x 100%

Conventional ASCUS+

For ASCUS/AGUS and more severe lesions, the diagnostic comparison statistically favored the ThinPrep method at three sites and was statistically equivalent at three sites.

One pathologist served as an independent reviewer for the six clinical sites, receiving both slides from cases where the two methods were either abnormal or discrepant. Since a true reference cannot be determined in such studies and therefore true sensitivity cannot be calculated, the use of an expert cytologic review provides an alternative to histologic confirmation by biopsy or human papillomavirus (HPV) testing as a means for determining the reference diagnosis.

The reference diagnosis was the more severe diagnosis from either of the ThinPrep or conventional Pap slides as determined by the independent pathologist. The number of slides diagnosed as abnormal at each site, compared to the reference diagnosis of the independent pathologist, provides the proportion of LSIL or more severe lesions (Table 8) and the proportion of ASCUS/AGUS or more severe lesions (Table 9). The statistical analysis allows a comparison of the two methods and a determination of which method is favored when using the independent pathologist for expert cytologic review as the adjudicator of the final diagnosis.

MAN-02624-001 Rev. 003 page 8 of 15

Table 8: Independent Pathologist Results by Site, LSIL and More Severe Lesions

Site

S1 50 33 25 0.170 Neither

S2 65 48 33 0.042 ThinPrep

S3 77 54 33 <0.001 ThinPrep

H1 116 102 81 <0.001 ThinPrep

H2 115 86 90 0.876 Neither

H3 126 120 112 0.170 Neither

For LSIL and more severe lesions, the diagnostic comparison statistically favored the ThinPrep method at three sites and was statistically equivalent at three sites.

Table 9: Independent Pathologist Results by Site, ASCUS/AGUS and More Severe Lesions

Site

S1 92 72 68 0.900 Neither S2 101 85 59 0.005 ThinPrep S3 109 95 65 <0.001 ThinPrep

H1 170 155 143 0.237 Neither H2 171 143 154 0.330 Neither H3 204 190 191 1.000 Neither

For ASCUS/AGUS and more severe lesions, the diagnostic comparison statistically favored the ThinPrep method at two sites and was statistically equivalent at four sites.

Cases

Positive

by Independent

Pathologist

Cases

Positive

Independent

Pathologist

ThinPrep

Positive

ThinPrep

Positive

Conventional

Positive

Conventional

Positive

p-Value Method Favored

MAN-02624-001 Rev. 003 page 9 of 15

Table 10 below shows the summary for all sites of the descriptive diagnosis for all Bethesda System categories.

Table 10: Summary of Descriptive Diagnosis

Descriptive Diagnosis

Number of Patients: 6747

Benign Cellular Changes: Infection:

Trichomonas Vaginalis Candida spp. Coccobacilli Actinomyces spp. Herpes Other

Reactive Cellular Changes Associated with:

Inflammation Atrophic Vaginitis Radiation Other

Epithelial Cell Abnormalities:

Squamous Cell: ASCUS favor reactive favor neoplastic undetermined LSIL HSIL Carcinoma Glandular Cell: Benign Endometrial cells in Postmenopausal Women Atypical Glandular Cells (AGUS) favor reactive favor neoplastic undetermined Endocervical Adenocarcinoma

Note: Some patients had more than one diagnostic subcategory.

ThinPrep

N % N %

1592

136 406 690

2 3

155

353

1159

501 128 161 213 469 167

9 0

23.6

2.0

6.0

10.2

0.0

2.3

5.2

0.5

0.0

0.4

17.2

7.4

1.9

2.4

3.2

7.0

2.5

0.0

0.1

0.3

0.1

0.0

0.2

0.0

Conventional

1591

185 259 608

3 8

285

385

1077

521 131 140 250 367 167

9 4 3 2 1

23.6

2.7

3.8

9.0

0.0

0.1

4.2

5.7

0.7

0.0

0.5

16.0

7.7

1.9

2.1

3.7

5.4

2.5

0.0

0.1

0.0

Table 11 shows the rates of detection for infection, reactive changes, and the total benign cellular changes for both the ThinPrep

and conventional methods at all sites.

Table 11: Benign Cellular Changes Results

N % N % Benign Cellular Changes Reactive

Total*

* Total includes some patients that may have had both an infection and reactive cellular change.

Infection

Changes

ThinPrep

1392 20.6 1348 20.0

412 6.1 471 7.0

1592 23.6 1591 23.6

Conventional

MAN-02624-001 Rev. 003 page 10 of 15

Tables 12, 13, and 14 show the specimen adequacy results for the ThinPrep method and conventional smear method for all of the study sites. Of the 7,360 total patients enrolled, 7,223 are included in this analysis. Cases with patient’s age less than 18 years or patients with a hysterectomy were excluded from this analysis.

Two additional clinical studies were conducted to evaluate specimen adequacy results when samples were deposited directly into the PreservCyt

vial, without first making a conventional Pap smear. This specimen collection technique is the intended use for the ThinPrep 2000 System. Tables 15 and 16 present the split sample and direct to vial results.

Table 12: Summary of Specimen Adequacy Results

Specimen Adequacy

Number of Patients: 7223

Satisfactory 5656 78.3 5101 70.6 Satisfactory for Evaluation but Limited by:

Air-Drying Artifact Thick Smear Endocervical Component Absent Scant Squamous Epithelial Component Obscuring Blood Obscuring Inflammation No Clinical History Cytolysis Other

Unsatisfactory for Evaluation:

Air-Drying Artifact Thick Smear Endocervical Component Absent Scant Squamous Epithelial Component Obscuring Blood Obscuring Inflammation No Clinical History Cytolysis Other

Note: Some patients had more than one subcategory.

ThinPrep Conventional

N % N %

1431

1 9

1140

150

141

12 19 10

136

0 0

106

5 0 0

Table 13: Specimen Adequacy Results

Conventional

ThinPrep SAT SBLB

UNSAT

SAT SBLB UNSAT TOTAL

4316 1302 38 5656

722

63 41

665 44 1431

19.8

0.0

0.1

15.8

2.1

0.8

2.0

0.2

0.3

0.1

1.9

0.0

0.3

1.5

0.3

0.1

0.0

0.4

32 136

2008

136

681

339

1008

119

114

47 58 41

0 4 9

27.8

1.9

0.9

9.4

0.7

4.7

14.0

0.1

1.6

0.4

1.6

0.2

0.1

0.2

0.7

0.8

0.6

0.0

0.1

TOTAL

SAT=Satisfactory, SBLB=Satisfactory But Limited By, UNSAT=Unsatisfactory

5101 2008 114

7223

MAN-02624-001 Rev. 003 page 11 of 15

Table 14: Specimen Adequacy Results by Site

Site Cases Thin

Prep SAT

Cases

1,386 1092 1178 265 204 29 4

Convent. SAT

Cases

Thin Prep

SBLB

Cases

Convent.

SBLB

Cases

Thin Prep

UNSAT

Cases

Convent.

UNSAT

Cases

S3 H1 H2 H3

All Sites

1,668 1530 1477 130 178 8 13 1,093 896 650 183 432 14 11 1,046 760 660 266 375 20 11 1,049 709 712 323 330 17 7

981 669 424 264 489 48 68

7,223 5656 5101 1431 2008 136 114

The Satisfactory But Limited By (SBLB) category can be broken down into many subcategories, one of which is the absence of Endocervical Component. Table 15 shows the Satisfactory But Limited By category “No ECC’s” for ThinPrep

and conventional slides.

Table 15: Specimen Adequacy Results by Site, SBLB Rates for no Endocervical Component.

SBLB Due to No ECC’s

Site Cases ThinPrep

SBLB-

no ECC’s

S1 S2

1,386 237 17.1% 162 11.7% 1,668 104 6.2% 73 4.4%

1,093 145 13.3% 84 7.7%

ThinPrep

SBLB-

no ECC’s (%)

Conventional

SBLB-

no ECC’s

Conventional

SBLB-

no ECC’s (%)

H1 H2 H3

All Sites

1,046 229 21.9% 115 11.0% 1,049 305 29.1% 150 14.3%

981 120 12.2% 97 9.9%

7,223 1140 15.8% 681 9.4%

For the results of the clinical study involving a split-sample protocol, there was a 6.4 percent difference between conventional and ThinPrep methods in detecting endocervical component. This is similar to previous studies using a split sample methodology.

DIRECT-TO-VIAL ENDOCERVICAL COMPONENT (ECC) STUDIES

For the intended use of the ThinPrep into a PreservCyt

vial, rather than splitting the cellular sampl e. It was expected that this woul d result in

2000 System, the cervical sampling device will be rinsed directly

an increase in the pick-up of endocervical cells and metaplastic cells. To verify this hypothesis, two studies were performed using the direct-to-vial method and are summarized in Table 16. Overall, no difference was found between ThinPrep and conventional methods in these two studies.

MAN-02624-001 Rev. 003 page 12 of 15

Table 16: Summary of Direct-to-vial Endocervical Component (ECC) Studies

Study Number of

Direct-to-Vial Feasibility Direct-to-Vial Clinical Study

1. Direct-to-Vial Feasibility study compared to overall clinical investigation conventional Pap smear SBLB-No Endocervical Component rate.

2. Direct-to-Vial Clinical study compared to site S2 clinical investigation conventional Pap smear SBLB-No Endocervical Component rate.

DIRECT-TO-VIAL HSIL+ STUDY

Following initial FDA approval of the ThinPrep System, Hologic conducted a multi-site direct-to-vial clinical study to evaluate the ThinPrep 2000 System versus conventional Pap smear for the detection of High Grade Squamous Intraepithelial and more severe lesions (HSIL+). Two types of patient groups were enrolled in the trial from ten (10) leading academic hospitals in major metropolitan areas throughout the United States. From each site, one group consisted of patients representative of a routine Pap test screening population and the other group made up of patients representative of a referral population enrolled at the time of colposcopic examination. The ThinPrep specimens were collected prospectively and compared against a historical control cohort. The historical cohort consisted of data collected from the same clinics and clinicians (if available) used to collect the ThinPrep specimens. These data were collected sequentially from patients seen immediately prior to the initiation of the study.

The results from this study showed a detection rate of 511 / 20,917 for the conventional Pap smear versus 399 / 10,226 for the ThinPrep slides. For these clinical sites and these study populations, this indicates a 59.7% increase in detection of HSIL+ lesions for the ThinPrep specimens. These results are summarized in Table 17.

Table 17: Summary of Direct-to-Vial HSIL+ Study

Site

S1 S2 S3 S4 S5 S6 S7 S8 S9

S10

Total CP

(n)

2,439 51 2.1 1,218 26 2.1 2,075 44 2.1 1,001 57 5.7 2,034 7 0.3 1,016 16 1.6 2,043 14 0.7 1,000 19 1.9 2,040 166 8.1 1,004 98 9.8 2,011 37 1.8 1,004 39 3.9 2,221 58 2.6 1,000 45 4.5 2,039 61 3.0 983 44 4.5 2,000 4 0.2 1,000 5 0.5 2,015 69 3.4 1,000 50 5.0

Evaluable

Patients

SBLB due to No

Endocervical

Component

Comparable Conventional Pap Smear Percentage

299 9.36% 9.43%1

484 4.96% 4.38%2

HSIL+

Percent

(%)

Total TP

(n)

HSIL+

Percent

(%)

Percent

Change (%)

+2.1 +168.5 +357.6 +177.3

+20.0

+111.1

+72.3 +49.6

+150.0

+46.0

Total

20,917 511 2.4 10,226 399 3.9

59.7( p<0.001)

Percent Change (%) = ((TP HSIL+/TP Total)/(CP HSIL+/CP Total)-1) *100

MAN-02624-001 Rev. 003 page 13 of 15

GLANDULAR DISEASE DETECTION – PUBLISHED STUDIES

The detection of endocervical glandular lesions is an essential function of the Pap test. However, abnormal glandular cells in the Pap sample may also originate from the endometrium or from extrauterine sites. The Pap test is not intended to be a screening test for such lesions.

When suspected glandular abnormalities are identified, their accurate classification as true glandular versus squamous lesions is important for proper evaluation and subsequent treatment (e.g. choice of excisional biopsy method versus conservative follow-up). Multiple peer-reviewed publications report on the improved ability of the ThinPrep 2000 System to detect glandular disease versus the conventional Pap smear. Although these studies do not consistently address sensitivity of different Pap testing methods in detecting specific types of glandular disease, the reported results are consistent with more frequent biopsy confirmation of abnormal glandular findings by the ThinPrep Pap Test compared to conventional cytology.

Thus, the finding of a glandular abnormality on a ThinPrep Pap Test slide merits increased attention for definitive evaluation of potential endocervical or endometrial pathology.

CONCLUSIONS

The ThinPrep populations and may be used as a replacement for the conventional Pap smear method for the detection of atypical cells, cervical cancer, or its precursor lesions, as well as all other cytologic categories as defined by The Bethesda System.

The ThinPrep 2000 System is significantly more effective than the conventional Pap smear for the detection of Low-grade Squamous Intraepithelial (LSIL) and more severe lesions in a variety of patient populations.

Specimen quality with the ThinPrep 2000 System is significantly improved over that of conventional Pap smear preparation in a variety of patient populations.

2000 System is as effective as the conventional Pap smear in a variety of patient

4-9

MATERIALS REQUIRED

MATERIALS PROVIDED

The ThinPrep 2000 System consists of the following components:

 ThinPrep Processor Instrument (Model TP 2000)  2 filter Caps  PreservCyt  ThinPrep Pap Test Filter for Gynecologic Applications  Power cord  Program Memory Card for Gynecologic Applications  ThinPrep Microscope slides  Waste bottle assembly - includes bottle, bottle cap,

tubing set, fittings, waste filter

Additional items supplied:

 ThinPrep 2000 Operator’s Manual  10 fixative vials

MATERIALS REQUIRED BUT NOT PROVIDED

 Slide staining system and reagents  20 ml PreservCyt  Standard laboratory fixative  ThinPrep  Coverslips and mounting media  Cervical collection device

Solution vial  2 spare filter seal O-rings

Solution vial

Pap Test Filter for Gynecologic Applications

MAN-02624-001 Rev. 003 page 14 of 15

STORAGE

 Store PreservCyt Solution between 15°C (59°F) and 30°C (86°F). Do not use beyond the expiration

date printed on the container.

 Store PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing between 15°C

(59°F) and 30°C (86°F) for up to 6 weeks.

 Store PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche

Diagnostics COBAS AMPLICOR CT/NG test between 4°C (39°F) and 25°C (77°F) for up to 6 weeks.

BIBLIOGRAPHY

1. Solomon D., Davey D, Kurman R, Moriarty A, O’Connor D, Prey M, Raab S,

Sherman M, Wilbur D, Wright T, Young N, for the Forum Group Members and the 2001 Bethesda Workshop. The 2001 Bethesda System Terminology for Reporting Results of Cervical Cancer. JAMA. 2002;287:2114-2119.

2. Jones HW. Impact of The Bethesda System, Cancer 77 pp. 1914-1918, 1995.

3. American Cancer Society. Cancer Facts and Figures, 1995.

4. Ashfaq R, Gibbons D, Vela C, Saboorian MH, Iliya F. ThinPrep Pap Test. Accuracy for

glandular disease. Acta Cytol 1999; 43: 81-5

Bai H, Sung CJ, Steinhoff MM: ThinPrep Pap Test promotes detection of glandular lesions of the endocervix. Diagn Cytopathol 2000;23:19-22

6. Carpenter AB, Davey DD: ThinPrep Pap Test: Performance and biopsy follow-up un a university

hospital. Cancer Cytopathology 1999; 87: 105-12

7. Guidos BJ, Selvaggi SM. Detection of endometrial adenocarcinoma with the ThinPrep Pap test.

Diagn Cytopathol 2000; 23: 260-5

8. Schorge JO, Hossein Saboorian M, Hynan L, Ashfaq R. ThinPrep detection of cervical and

endometrial adenocarcinoma: A retrospective cohort study. Cancer Cytopathology 2002; 96: 33843

9. Wang N, Emancipator SN, Rose P, Rodriguez M, Abdul-Karim FW. Histologic follow-up of

atypical endocervical cells. Liquid-based, thin-layer preparation vs. conventional Pap smear. Acta Cytol 2002; 46: 453-7

TECHNICAL SERVICE AND PRODUCT INFORMATION

For technical service and assistance related to use of the ThinPrep 2000 System, contact Hologic: Telephone: 1-800-442-9892 Fax: 1-508-229-2795

For international or toll-free blocked calls, please contact 1-508-263-2900. Email: info@hologic.com

Hologic, PreservCyt, ThinPrep, and associated logos are registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 1-800-442-9892 www.hologic.com

Hologic UK Unit 2, Link 10 Napier Way Crawley, West Sussex RH10 9RA United Kingdom +44 1293 522 080

AW-07100-001 Rev. 003

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

ThinPrep 2000 System

for Gynecologic Use

ThinPrep 2000 System

ThinPrep® 2000 System For Gynecologic Use

Section 1 (white tabs) describes the use of the ThinPrep

2000 system for gynecologic applications. In addition, it

contains all information regarding the installation, operation, and

maintenance of the ThinPrep

2000 processor.

ThinPrep 2000 Processor Operator’s Manual

This page intentionally left blank.

ThinPrep 2000 Processor Operator’s Manual

Chapter One

INTRODUCTION

TABLE OF CONTENTS

SECTION A:

SECTION B:

SECTION C

SECTION D:

SECTION E:

SECTION F:

Chapter Two

THINPREP 2000 INSTALLATION

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

Overview and Function of the ThinPrep

Principles of Operation 1.7

: ThinPrep 2000 System Technical Specifications 1.12

Internal Quality Control 1.16

ThinPrep 2000 Hazards 1.16

Disposal 1.19

General 2.1

Action Upon Delivery 2.1

Preparation Prior to Installation 2.2

Internal Packaging Removal 2.2

Connecting the Waste Bottle 2.6

Inserting the Program Memory Card 2.7

2000 System 1.1

SECTION G:

SECTION H:

SECTION I

SECTION J:

SECTION K:

Chapter Three

PRESERVCYT SOLUTION

SECTION A:

SECTION B:

Connecting the Power Cord 2.8

Turning On Your ThinPrep 2000 Processor 2.9

: Run a Blank Sample 2.11

Storage and Handling - Post Installation 2.12

Turning Off the ThinPrep 2000 Processor 2.12

Introduction 3.1

PreservCyt® Solution 3.2

ThinPrep 2000 Processor Operator’s Manual

iii

TABLE OF CONTENTS

Chapter Four

GYNECOLOGIC SAMPLE PREPARATION

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

Introduction 4.1

Collection Preparation 4.2

Specimen Collection 4.3

Special Precautions 4.5

Specimen Processing 4.6

Sample Preparation Troubleshooting 4.7

Chapter Five A

OPERATING INSTRUCTIONS

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

:Introduction 5A.1

Optional Instructions for Ancillary Testing 5A.2

Material Requirements 5A.4

Pre-operation Checklist 5A.5

Overview of Loading the ThinPrep

SECTION F:

Loading the PreservCyt Sample Vial 5A.7

2000 Processor 5A.6

SECTION G:

SECTION H:

SECTION I:

SECTION J:

SECTION K:

SECTION L:

SECTION M:

SECTION N:

ThinPrep 2000 Processor Operator’s Manual

Loading the ThinPrep Pap Test Filter 5A.8

Loading the ThinPrep Microscope Slide 5A.11

Loading the Fixative Vial 5A.14

Closing the Door 5A.15

Selecting and Initiating a Sequence 5A.16

Unloading the ThinPrep 2000 Processor 5A.18

Interrupting the Slide Preparation Process 5A.20

Status, Maintenance, and Test Screens 5A.21

TABLE OF CONTENTS

Chapter Five B

OPERATING INSTRUCTIONS

FOR PROCESSING COBAS AMPLICOR™ CT/NG SAMPLES

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

SECTION G:

SECTION H

SECTION I

: Loading the ThinPrep Microscope Slide 5B.11

SECTION J:

SECTION K

SECTION L

SECTION M:

SECTION N:

SECTION O

Introduction 5B.1

Material Requirements 5B.2

Pre-operation Checklist 5B.4

Overview of

Loading the ThinPrep

2000 Processor 5B.5

Preparing the Filter Caps 5B.6

Loading the Fixative Vial 5B.7

Loading the ThinPrep Pap Test Filter 5B.8

: Loading the PreservCyt Sample Vial 5B.10

Closing the Door 5B.14

: Selecting and Initiating a Sequence 5B.15

: Unloading the PreservCyt Sample Vial 5B.18

Unloading the ThinPrep Microscope Slide 5B.11

Unloading the Filter Assembly 5B.20

: Interrupting the Slide Preparation Process 5B.21

SECTION P:

Status, Maintenance, and Test Screens 5B.22

Chapter Six

INSTRUMENT TROUBLESHOOTING

SECTION A:

SECTION B:

SECTION C:

SECTION D:

Introduction 6.1

How to use this Section 6.2

Contents 6.3

Error History 6.37

ThinPrep 2000 Processor Operator’s Manual

TABLE OF CONTENTS

Chapter Seven

MAINTENANCE

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

SECTION G:

SECTION H:

SECTION I:

SECTION J:

SECTION K

SECTION L:

SECTION M:

Introduction 7.1

Emptying Waste Bottle 7.2

Filter Cap Cleaning 7.4

Filter Cap O-ring Lubrication 7.5

Filter Seal O-ring Replacement 7.6

Door Cleaning 7.7

Cap Seal Cleaning 7.8

General Cleaning 7.9

Waste Tubing Replacement 7.10

Waste Filter Replacement 7.14

: Emptying and Cleaning the Catch Tray 7.16

Moving The ThinPrep® 2000 Processor 7.17

Maintenance Schedule 7.18

Chapter Eight

FIXATION, STAINING, AND COVERSLIPPING

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

Introduction 8.1

Fixation 8.2

Staining 8.3

Coverslipping 8.6

References 8.6

Chapter Nine

THINPREP PAP TEST TRAINING PROGRAM 9.1

INDEX

ThinPrep 2000 Processor Operator’s Manual

1. Introduction

INTRODUCTION

SECTION

Chapter One

Introduction

This chapter describes an overview and the principles of operation of the ThinPrep® 2000 system for gynecologic sample processing.

Note:

Specific processing steps using the ThinPrep 2000 system must be followed for specimens

undergoing subsequent testing for Roche Diagnostics COBAS AMPLICOR™ CT/NG test. (See Chapter 5B, “Operating Instructions for Processing COBAS AMPLICOR™ CT/NG Samples”.)

Chlamydia trachomatis

and

Neisseria gonorrhoeae

using the

OVERVIEW AND FUNCTION OF THE THINPREP® 2000 SYSTEM

The ThinPrep 2000 system is used in the processing of fluid-based gynecologic specimens for use with the ThinPrep

microscope slides in preparation for staining, coverslipping and screening. The processor produces thin, uniform preparations of cells on ThinPrep microscope slides.

Indication for Use

Intended Use

The ThinPrep 2000 system is intended as a replacement for the conventional method of Pap smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda System for Reporting

Cervical/Vaginal Cytologic Diagnoses

Pap test. The samples are collected, processed, transferred and fixed onto

1. Kurman RJ, Solomon D. The Bethesda System for Reporting Cervical/Vaginal Cytologic Diseases, Springer-Verlag, New York 1994.

ThinPrep 2000 Processor Operator’s Manual

1.1

INTRODUCTION

ThinPrep

2000

CYTYC

corporation

Figure 1-1 The ThinPrep 2000 Processor and Waste Bottle

Summary and Explanation of the System

The ThinPrep process begins with the patient’s gynecologic sample being collected by the clinician using a cervical sampling device which, rather than being smeared on a microscope slide, is

immersed and rinsed in a vial filled with PreservCyt

Solution. The ThinPrep sample vial is then

capped, labeled, and sent to a laboratory equipped with a ThinPrep 2000 processor.

At the laboratory, the PreservCyt sample vial is placed into a ThinPrep 2000 processor and a gentle dispersion step breaks up blood, mucus, non-diagnostic debris, and thoroughly mixes the cell sample. The cells are then collected on a ThinPrep Pap test filter specifically designed to collect diagnostic cells. The ThinPrep 2000 processor constantly monitors the rate of flow through the ThinPrep Pap test filter during the collection process in order to prevent the cellular presentation from being too scant or too dense. A thin layer of cells is then transferred to a glass slide in a 20-mmdiameter circle. The slide is then automatically deposited into a fixative solution.

1.2

ThinPrep 2000 Processor Operator’s Manual

The ThinPrep Sample Preparation Process

1. Dispersion 2. Cell Collection 3. Cell Transfer

(1) Dispersion

The ThinPrep Pap test filter rotates within the sample vial, creating currents in the fluid that are strong enough to separate debris and disperse mucus, but gentle enough to have no adverse effect on cell appearance.

(2) Cell Collection

A gentle vacuum is created within the ThinPrep Pap test filter, which collects cells on the exterior surface of the membrane. Cell collection is controlled by the ThinPrep 2000 processor’s software that monitors the rate of flow through the ThinPrep Pap test filter.

(3) Cell Transfer

After the cells are collected on the membrane, the ThinPrep Pap test filter is inverted and gently pressed against the ThinPrep microscope slide. Natural attraction and slight positive air pressure cause the cells to adhere to the ThinPrep microscope slide resulting in an even distribution of cells in a defined circular area.

INTRODUCTION

As with conventional Pap smears, slides prepared with the ThinPrep 2000 system are examined in the context of the patient’s clinical history and information provided by other diagnostic procedures such as colposcopy, biopsy, and human papillomavirus (HPV) testing, to determine patient management.

Limitations

•

Gynecologic samples collected for preparation using the ThinPrep 2000 system should be collected using a broom-type cervical collection device or endocervical brush/plastic spatula combination collection device.

ThinPrep 2000 Processor Operator’s Manual

1.3

INTRODUCTION

•

Preparation of microscope slides using the ThinPrep 2000 system should be performed only by personnel who have been trained by Hologic or by organizations or individuals designated by Hologic.

•

Evaluation of microscope slides produced with the ThinPrep 2000 system should be performed only by cytotechnologists and pathologists who have been trained to evaluate ThinPrep-prepared slides by Hologic or by organizations or individuals designated by Hologic.

•

Supplies used in the ThinPrep 2000 system are those designed and supplied by Hologic specifically for the ThinPrep 2000 system. These include PreservCyt Solution vials, ThinPrep Pap test filters, and ThinPrep microscope slides. These supplies are required for proper performance of the system and cannot be substituted. Product performance will be compromised if other supplies are used. After use, supplies should be disposed of in accordance with local, state, and federal regulations.

•

A ThinPrep Pap test filter must be used only once and cannot be reused.

Warnings

•

PreservCyt Solution contains methanol which is poisonous and may be fatal or cause blindness if swallowed. Methanol vapor may be harmful. PreservCyt Solution is flammable; keep away from fire, heat, sparks, and flame. Other solutions must not be substituted for PreservCyt Solution. PreservCyt Solution should be stored and disposed of in accordance with local, state, and federal regulations.

•

Strong oxidizers, such as bleach, are incompatible with PreservCyt Solution and therefore should not be used to clean the waste bottle.

• Do not process a cerebral spinal fluid (CSF) specimen or other sample type that is suspected of possessing prion infectivity (PrPsc) derived from a person with a TSE, such as CreutzfeldtJakob disease, on a ThinPrep processor. A TSE-contaminated processor cannot be effectively decontaminated and therefore must be properly disposed of in order to avoid potential harm to users of the processor or service personnel.

Precautions

•

This equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the operator’s manual, may cause interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at his/her own expense.

• PreservCyt Solution between 15°C (59°F) and 30°C (86°F) and tested within 6 weeks of collection.

with

cytologic sample intended for ThinPrep Pap testing must be stored

1.4

ThinPrep 2000 Processor Operator’s Manual

INTRODUCTION

• PreservCyt Solution

with

cytologic sample intended for CT/NG testing using the Roche Diagnostics COBAS AMPLICOR CT/NG test must be stored between 4°C (39°F) and 25°C (77°F) and tested within 6 weeks of collection.

PreservCyt Solution was challenged with a variety of microbial and viral organisms. The following table presents the starting concentrations of viable organisms and the number of viable organisms found after 15 minutes in the PreservCyt Solution. The log reduction of viable organisms is also presented. As with all laboratory procedures, universal precautions should be followed.

Organism Initial Concentration

Candida albicans

Aspergillus niger*

Escherichia coli

Staphylococcus aureus

Pseudomonas aeruginosa

Mycobacterium tuberculosis**

5.5 x 10

4.8 x 10

2.8 x 10

2.3 x 10

2.5 x 10

9.4 x 10

CFU/mL

Log Reduction after

15 min.

>4.7

2.7

>4.4

4.9

Rabbitpox virus

HIV-1

* After 1 hour >4.7 log reduction

** After 1 hour >5.7 log reduction *** Data is for 5 minutes

6.0 x 10

1.0 x 10

PFU/mL

7.5

TCID50/mL

5.5***

7.0***

MATERIALS REQUIRED

Materials Provided

The ThinPrep 2000 system consists of the following components:

•

ThinPrep processor instrument (Model: ThinPrep 2000)

•

PreservCyt Solution vial

•

Gyn ThinPrep Pap test filter (clear)

•

Program Memory Card

ThinPrep 2000 Processor Operator’s Manual

1.5

INTRODUCTION

•

Power cord

•

2 Filter caps

•

2 spare filter seal O-rings

•

Waste bottle assembly — includes bottle, bottle cap, tubing set, fittings, waste filter

•

ThinPrep microscope slides

Additional items supplied:

•

ThinPrep 2000 System Operator’s Manual

•

10 fixative vials

•

Cervical collection device

•

Sealed cylinder

Materials Required But Not Provided

•

Slide staining system and reagents

•

Standard laboratory fixative

•

Coverslips and mounting media

•

Lint-free wipes

Storage

• Store PreservCyt Solution between 15°C (59°F) and 30°C (86°F). Do not use beyond the expiration date printed on the container.

• Store PreservCyt Solution 15°C (59°F) and 30°C (86°F) for up to 6 weeks.

• Store PreservCyt Solution Diagnostics COBAS AMPLICOR CT/NG test between 4°C (39°F) and 25°C (77°F) for up to 6 weeks.

with

cytologic sample intended for ThinPrep Pap testing between

with

cytologic sample intended for CT/NG testing using the Roche

1.6

ThinPrep 2000 Processor Operator’s Manual

INTRODUCTION

SECTION

PRINCIPLES OF OPERATION

The ThinPrep 2000 processor makes use of mechanical, pneumatic, and fluidic principles for cell dispersion, collection, and transfer. A rotary drive mechanism gently disperses samples. A pneumatic/fluidic system, controlled by a microprocessor, monitors cell collection. Electrochemical principles, the pneumatic and fluidic systems, the natural binding qualities of cells, and the qualities of the ThinPrep Pap test filter are responsible for cell transfer.

Each ThinPrep processor slide preparation processing sequence is optimized for the biological characteristics of the various cytological specimens.

The ThinPrep processor slide preparation process can be divided into the following phases:

Sample preparation/instrument loading

•

Start of cycle

•

Fluid level detection

•

Dispersion

•

Filter wetting

•

Cell collection

•

Waste clearing

•

Bubble point

•

Cell transfer

•

Slide ejection

•

Completion of cycle

The following sections describe the principles of each of these phases in detail.

ThinPrep 2000 Processor Operator’s Manual

1.7

INTRODUCTION

Sample Preparation/Instrument Loading

Before the ThinPrep processor can process gynecologic samples, the samples must be placed into PreservCyt Solution. Gynecologic samples must be prepared according to the protocols described in Chapter 4, “Gynecologic Sample Preparation”. Once the cells are added to the PreservCyt Solution vial by the appropriate method, the instrument can process the sample vial.

In preparation for sample processing, the operator loads four essential items into the ThinPrep 2000 processor: a PreservCyt Sample vial, a ThinPrep Pap test filter attached to the filter cap, a ThinPrep slide and a fixative vial containing a standard laboratory fixative. The processes of loading and operating the instrument are explained in Chapter 5A, “Operating Instructions”.

Start of Cycle

When the operator initiates a sequence, the ThinPrep 2000 processor verifies installation of disposables, motor positions, and the positive and negative pressures in the pressure reservoirs. After this the instrument processes the slide using the selected sequence.

Fluid Level Detection

The cap seal lowers to seal the filter assembly and the sample vial is raised towards the filter membrane. The sample vial stops when the filter membrane makes contact with the surface of fluid. If the fluid level is satisfactory, the instrument will continue the slide preparation process. An error message and audible alarm indicate an unsatisfactory fluid level.

Dispersion

The cap seal lifts and the dispersion system rotates the ThinPrep Pap test filter assembly within the cell suspension, creating shear forces in the fluid that are strong enough to separate randomly joined material and disperse mucus, and are not known to have an adverse effect on the cellular architecture or on adhesive forces joining diagnostically relevant groups of cells.

1.8

ThinPrep 2000 Processor Operator’s Manual

INTRODUCTION

Negative pressure creates a vacuum

ThinPrep Pap test filter

Flow of fluid

Filter pores

Filter Wetting

The head seal lowers to seal the filter assembly. Negative pressure is briefly applied, drawing a small amount of fluid through the ThinPrep Pap test filter to wet it. Following wetting, the system gently blows out the liquid in the ThinPrep Pap test filter. This clears any cellular material from the filter surface.

Cell Collection

The filter membrane is biologically neutral and is mounted at one end of the ThinPrep Pap test filter cylinder. The membrane is a flat, smooth, porous surface that collects the cellular material on one plane.

The pneumatic system applies negative pressure to the filter in a series of pulses. These negative pressure pulses (sips) draw PreservCyt Solution through the filter membrane and collect suspended cellular material onto the outer membrane surface.

The collection process ceases when a target filter coverage, predetermined by the processor sequence, is attained. Cell collection is controlled by an embedded microprocessor that monitors the pressure in the ThinPrep Pap test filter cylinder. After collection, the cells sit on a single plane over the pores, ready for transfer to the slide. Figure 1-2 illustrates cell collection.

Figure 1-2 Cell Collection

ThinPrep 2000 Processor Operator’s Manual

1.9

INTRODUCTION

Waste Clearing

When collection ends, the ThinPrep Pap test filter is withdrawn from the sample vial and the filtrate is aspirated into the waste bottle as the filter is inverted. The collected cells remain on the ThinPrep Pap test filter due to the negative holding pressure.

Bubble Point

Bubble point removes excess fluid from the filter membrane prior to transferring cells onto the slide to enhance cell adhesion to the slide.

Bubble point is performed after all of the fluid is evacuated. This is evident by the bubbling activity on the inside of the filter membrane. Cells do not air-dry during bubble point.

Cell Transfer

When bubble point is complete, the slide handler moves the slide into contact with the inverted ThinPrep Pap test filter.

The natural adhesion properties of cells and the electrochemical charge of the glass slide are responsible for the transfer of cells from the filter membrane to the slide. The cells have a higher affinity for the glass slide than for the membrane; slight positive air pressure behind the filter membrane enhances cell transfer.

Slide Ejection

Once cell transfer is complete, the slide is removed from contact with the filter and automatically ejected into the fixative vial.

Cycle Completion

All the motorized mechanisms return to their initial positions and the display returns to the Main Menu. If the system detects an error during the process, a message will be displayed and an audible alarm will sound.

1.10

ThinPrep 2000 Processor Operator’s Manual

Figure 1-3 Overview of Processing

Pap test filter are in place. Operator initiates sequence.

2. Elevator raises sample to filter and system checks for appropriate fluid level.

3. Dispersion. ThinPrep Pap test filter rotates to disperse sample material.

4. Filter Wetting. Liquid is drawn into the filter then pushed out.

drawn into ThinPrep Pap test filter in a controlled manner.

6. Waste Clearing. Filter is inverted, waste is cleared to waste bottle and sample vial is lowered.

7. Cell Transfer. Slide holder contacts filter. Cells are transferred to slide.

8. Slide Ejection. Slide is deposited into fixative bath. Filter returns to starting point.

INTRODUCTION

ThinPrep 2000 Processor Operator’s Manual

1.11

INTRODUCTION

SECTION

ThinPrep 2000

Fix vials

Power cord

Program Memory Card

Operator’s manual Filter cap assemblies

Waste bottle with cap and filter

THINPREP 2000 SYSTEM TECHNICAL SPECIFICATIONS

Overview of Components

Figure 1-4 ThinPrep 2000 System Components

1.12

ThinPrep 2000 Processor Operator’s Manual

ThinPrep 2000 Dimensions and Clearances

19.5”/50 cm

15”/38 cm

17”/43 cm

18”/46 cm

6”/15 cm

22.5/59 cm

18/46 cm

24/61 cm

Figure 1-5 Processor Dimensions

INTRODUCTION

Figure 1-6 Processor Clearances

ThinPrep 2000 Processor Operator’s Manual

1.13

INTRODUCTION

Dimensions and Weight (Approximate)

ThinPrep Processor: 19.5”/50 cm H x 18”/46 cm W x 15”/38 cm D

41 lbs/18.6 kg

Waste Bottle: 17”/43 cm H x 6”/15 cm diameter

Environmental

Operating Temperature

15–32°C 59–90°F

Operating Humidity

20%–90% RH, non-condensing

Pollution Degree: II

, in accordance with IEC 60664.

Category II,

environment.

Altitude

Atmospheric Pressure:

the ThinPrep 2000 is for indoor use only in an office or a clean laboratory

: 0 meters (sea level) to 2000 meters.

1100 millibar to 500 millibar.

Power

Electrical Voltage

100/120 VAC at 2 amps 220/240 VAC at 1 amp

Frequency Power

47–63 Hz Maximum 200 watts

Fusing

Two 3.15A/250V 5x20 mm glass, time delay

1.14

ThinPrep 2000 Processor Operator’s Manual

INTRODUCTION

Pin 1

Pin 5

Pin 9 Pin 6

Pin Signal Description 1 CD Carrier Detect 2 RD Receive Data 3TD Transmit Data 4 DTR Data Termina l Ready 5 SG Signal Ground 6 DSR Data Set Ready 7 R TS Request To Send 8 CTS Clear To Send 9 RI Ring Indicator

RS-232 Connection

ThinPrep 2000 Standards

The ThinPrep 2000 System has been tested and certified by a U.S. nationally recognized testing Laboratory (NRTL) to comply with current Safety, Electro-Magnetic Interference (EMI) and ElectroMagnetic Compatibility (EMC) standards. Refer to the processor product label, located on the rear of the instrument, to see the safety certification markings.

This equipment meets the emission and immunity requirements of IEC 61326-2-6. This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. The electromagnetic environment should be evaluated prior to operation.

Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g., unshielded intentional radio frequency sources), as these may interfere with the proper operation.

Caution:

compliance could void the user’s authority to operate the equipment.

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protections against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy; and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at his own expense.

This product is

Changes or modifications to this unit not expressly approved by the party responsible for

in vitro diagnostic

(IVD) medical equipment.

ThinPrep 2000 Processor Operator’s Manual

1.15

INTRODUCTION

SECTION

INTERNAL QUALITY CONTROL

Power On Self Test (POST)

When the ThinPrep 2000 processor is powered on (refer to page 2.9), the system goes through a selfdiagnostic test. The electrical, mechanical and software/communications subsystems are tested to confirm that each performs properly. The operator is alerted to malfunctions by a message on the LCD display and audible beeps.

THINPREP 2000 HAZARDS

The ThinPrep 2000 system is intended to be operated in the manner specified in this manual. Be sure to review and understand the information listed below in order to avoid harm to operators and/or damage to the instrument.

If this equipment is used in a manner not specified by the manufacturer, then the protection provided by the equipment may be impaired.

Warnings, Cautions and Notes

The terms

WARNING

A death.

CAUTION

inaccurate data or invalidate a procedure, although personal injury is unlikely.

Note

WARNING, CAUTION

advises against certain actions or situations that could result in personal injury or

advises against actions or situations that could damage equipment, produce

provides useful information within the context of the instructions being provided.

and

Note

have specific meanings in this manual.

Symbols Used on the Instrument

The following symbols are used on this instrument:

1.16

ThinPrep 2000 Processor Operator’s Manual

INTRODUCTION

Attention, refer to accompanying documents.

Protective Conductor Terminal (internal use only , not accessible to operators).

Waste Electrical and Electronic Equipment - contact Hologic for disposal of the instrument.

ThinPrep 2000 Processor Operator’s Manual

1.17

INTRODUCTION

Do not dispose symbolSlide insertion label Serial number label

Model/rating label

Moving parts

label

Flammable liquids

label

(Internal)

Location of Labels Used on the Instrument

Figure 1-7 Location of Labels Used on the Instrument

1.18

ThinPrep 2000 Processor Operator’s Manual

Warnings Used in this Manual:

SECTION

INTRODUCTION

WARNING:

The instrument contains moving parts. Keep hands, loose clothing, jewelry, etc., clear.

WARNING:

To ensure safe operation of the instrument, use a three-wire grounded outlet. Disconnection from the power supply source is by removal of the power cord.

WARNING:

The instrument uses microscope slides, which have sharp edges. In addition, the slides may be broken in their storage packaging or on the instrument. Use caution when handling glass slides and cleaning the instrument.

WARNING:

Flammable liquid. Keep away from fire, heat, sparks and flame. Evaporating alcohol could create a fire hazard.

WARNING:

PreservCyt Solution contains methanol. Danger. Poison. Vapor harmful. Refer to Material Safety Data Sheet (MSDS) for safety and handling instructions. Wear protective laboratory gear.

Moving Parts

Grounded Outlet

Glass

Flammable Liquid

Poisonous Substance

DISPOSAL

Disposal of Consumable Items

•

Fix Reagent. Follow local, state, provincial and federal or county guidelines. Dispose of

all solvents as hazardous waste.

•

Waste Bottle Contents. Dispose of all solvents as hazardous waste. Follow local, state, provincial and federal or county guidelines. As with all laboratory procedures, universal precautions should be followed.

•

PreservCyt Solution. Follow local, state, provincial and federal or county guidelines. Dispose of all solvents as hazardous waste.

•

Used Filters. Dispose of as regular waste.

•

Base Liners (Absorbent Pads). Dispose of as regular waste. (If dripping wet, dispose of as hazardous waste.)

•

Used Filter Seal O-Rings and Filter Caps. Dispose of as regular waste.

ThinPrep 2000 Processor Operator’s Manual

1.19

INTRODUCTION

•

Waste Filter. Dispose of as regular waste.

•

Pinch Valve Tubing. Dispose of as regular waste.

•

CytoLyt Solution. Dispose of as hazardous waste. Follow local, state, provincial and federal or county guidelines. Dispose of all solvents as hazardous waste.

•

Broken Glass. Dispose of in a Sharps container.

Disposal of the Equipment

Waste Electrical & Electronic Equipment (WEEE)

Hologic is dedicated to meeting country specific requirements associated with the environmentally sound treatment of our products. Our objective is to reduce the waste arising from our electrical and electronic equipment. Hologic realizes the benefits of subjecting such WEEE equipment to potential reuse, treatment, recycling or recovery to minimize the amount of hazardous substances entering the environment.

Your Responsibility

As a Hologic customer, you are responsible for ensuring that devices marked with the symbol shown below are not placed into the municipal waste system unless authorized to do so by the authorities in your area. Please contact Hologic (see below) prior to disposing any electrical equipment provided by Hologic.

Symbol Used on the Instrument

The following symbol is used on this instrument:

Do not dispose in municipal waste.

Contact Hologic (see below) for information

regarding proper disposal.

Reclamation

Hologic will provide for the collection and proper reclamation of electrical devices we provide to our customers. Hologic strives to reuse Hologic devices, subassemblies, and components whenever possible. When reuse is not appropriate, Hologic will ensure the waste material is properly disposed of.

1.20

ThinPrep 2000 Processor Operator’s Manual

Contact Information

Corporate Headquarters

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Tel: (USA and Canada)

1-800-442-9892

Fax: 1-508-263-2967

Authorized European Representative

Hologic UK Ltd. Unit 2, Link 10 Napier Way Crawley, West Sussex RH10 9RA United Kingdom Tel: +44 1293 522 080

INTRODUCTION

Fax: +44 1293 528 010

ThinPrep 2000 Processor Operator’s Manual

1.21

INTRODUCTION

This page intentionally left blank.

1.22

ThinPrep 2000 Processor Operator’s Manual

2. ThinPrep 2000

Installation

2. ThinPrep 2000

THINPREP 2000 INSTALLATION

SECTION

Chapter Two

ThinPrep 2000 Installation

GENERAL

This section provides information for unpacking and installing your ThinPrep® processor. Please and system operation.

completely

follow the installation procedure, step by step, to ensure proper installation

ACTION UPON DELIVERY

Inspect the packing cartons for damage. Report any damage immediately to the shipper and/or Hologic Technical Support as soon as possible. (Refer to Service Information at the back of this manual.)

If the instrument will not be unpacked right away, store the equipment in a suitable environment until installation: cool, dry, vibration-free area.

Before proceeding with the installation of the ThinPrep 2000 processor, compare the contents of the shipping container(s) with the checklist below. If any items are missing or damaged, contact Hologic Technical Support. For customers outside of the USA, please contact your Hologic distributor.

Checklist for contents of shipping container and accessory kit.

•

ThinPrep 2000 processor

•

ThinPrep 2000 Operator’s Manual

•

Program Memory Card

•

Power cord, 6 feet (1.8 m)

•

2 filter caps

•

2 spare filter seal O-rings

•

Waste bottle assembly — includes bottle, bottle cap,

tubing set, fittings, waste filter

•

10 fixative vials

•

#1 tip (small) Phillips head screwdriver

•

#2 tip (large) Phillips head screwdriver with string attached

ThinPrep 2000 Processor Operator’s Manual

2.1

THINPREP 2000 INSTALLATION

SECTION

•

High-vacuum silicone grease

•

Base liners (absorbent pads)

•

Replacement tubing for evacuation system

•

Waste bottle cap for bottle transport

•

Sealed cylinder for testing

•

Dispenser pump

•

ThinPrep microscope slides 100-pack

Caution:

idate your warranty.

Turning the power on before instructed to do so can damage the instrument and inval-

PREPARATION PRIOR TO INSTALLATION

Location Selection Information

Locate the ThinPrep 2000 processor near a 3-prong grounded power outlet that is free of voltage fluctuations and power surges. As with most laboratory equipment, it may be necessary to install a line voltage stabilizer to eliminate power fluctuations and minimize interference from other systems.

During operation the ThinPrep 2000 Processor is sensitive to vibrations. It should be placed on a sturdy bench that can support the 41 lbs (18.6 kg) that the instrument weighs. The bench should be away from centrifuges, vortexors, or any other equipment that may cause vibrations. If the location of the instrument must be in proximity to one of these devices, it should not be operating at the same time as any of these other devices.

Allowing for adequate clearances, the following space is required for the ThinPrep Processor: H =

22.5"/59 cm W = 24"/61 cm D = 18"/46c m. (Refer to Figure 1-6.)

The waste bottle may be placed either on the bench with the processor or below the processor. The waste bottle will occupy an area approximately a 6"/15 cm square by 17"/43 cm high.

INTERNAL PACKAGING REMOVAL

The inside mechanism of the ThinPrep 2000 processor is secured for shipment in two areas. A formed foam insert secures the rotating plate in a vertical position, and a small foam block secures the slide handler. These internal securements must be removed before operating the instrument. Do not turn on the power of the processor until instructed to do so.

2.2

ThinPrep 2000 Processor Operator’s Manual

THINPREP 2000 INSTALLATION

Caution:

idate your warranty.

Rotating Plate Packaging Removal:

1. Open the door of the ThinPrep 2000 processor by sliding it to the right.

2. Grasp the foam shipping insert and pull it straight forward, out of the instrument.

Note:

Turning the power on before instructed to do so can damage the instrument and inval-

The foam insert fits very tightly in the instrument. Use care when removing it to pull straight

outward and not dislodge any of the mechanisms.

ThinPrep 2000 Processor Operator’s Manual

2.3

THINPREP 2000 INSTALLATION

Foam shipping insert

Rotating plate

Grasp and pull the foam insert straight forward, out of the instrument

Figure 2-1 Removing the Rotating Plate Packaging

3. The rotating plate can be turned clockwise into a horizontal position.

2.4

ThinPrep 2000 Processor Operator’s Manual

THINPREP 2000 INSTALLATION

Location of the slide handler when packaged

Remove the foam block

4. Save the foam insert for subsequent instrument packaging.

Slide Handler Packaging Removal:

1. Locate the orange foam block securing the slide handler. The slide handler is secured in the upper left-hand corner of the instrument. Refer to Figure 2-2.

Figure 2-2 Removing the Slide Handler Packaging

2. Carefully remove the foam block that is between the slide handler and the four horizontal ejector pins. The foam block may still be between the four ejector pins in the upper left-hand corner of the unit. The slide handler may be rotated to a horizontal position to remove the foam block.

3. Close the door by sliding it to the left.

4. Save the foam block for subsequent instrument packaging.

ThinPrep 2000 Processor Operator’s Manual

2.5

THINPREP 2000 INSTALLATION

SECTION

Sensor tubing

Waste tubing

Vacuum tubing

Blue

Yellow

CONNECTING THE WASTE BOTTLE

Caution:

ThinPrep Processor. Refer to Chapter 7, “Maintenance” for details regarding the use of bleach.

1. The waste bottle should be placed at the same height or below the ThinPrep processor. Do not place the waste bottle above the instrument.

2. Ensure that the waste bottle cap is tightly secured. The waste bottle must rest in an upright position. Do not allow the waste bottle to lay on its side.

3. Locate the three waste bottle connections at the rear of the ThinPrep processor. Refer to Figure 2-

3. Ensure that the buttons of the connectors are in the down/inward position.

At no time should bleach be present in the waste bottle while it is connected to the

Figure 2-3 Waste Tubing Connections

4. Connect the color-coded waste tubing connectors to the corresponding connectors located in the rear of the instrument. When the proper connection has been established, the buttons on the connectors pop up/outward with a click sound. It may be necessary to push the button in before placing the waste tubing connector into the instrument connector.

2.6

ThinPrep 2000 Processor Operator’s Manual

THINPREP 2000 INSTALLATION

SECTION

Confirm that the power is OFF

Caution:

cessor.

Caution:

the procedure in Chapter 7, “Maintenance”.

Do not attempt to mismatch tubing connection. This may result in damage to your pro-

Always empty the waste bottle before it reaches the maximum liquid level line. Follow

INSERTING THE PROGRAM MEMORY CARD

1. Confirm the power to the unit is off.

Caution:

2. Locate the receptacle for the Program Memory Card (PMC) in the center of the rear panel of the ThinPrep 2000 processor.

3. Orient the PMC as indicated by the arrows on the label of the card.

4. Insert the PMC into the unit as shown in Figure 2-4. Continue to insert the card until the small black button at the top of the receptacle snaps out. If the PMC does not enter the unit smoothly, do not force it into the ThinPrep 2000 processor socket.

ALWAYS turn off the power before inserting or removing the Program Memory Card.

Figure 2-4 Inserting the Program Memory Card

ThinPrep 2000 Processor Operator’s Manual

2.7

THINPREP 2000 INSTALLATION

SECTION

5. To remove the PMC, simply depress the black button at the top of the receptacle and gently remove the PMC.

CONNECTING THE POWER CORD

Caution:

idate your warranty.

1. Ensure that the power switch, located on the rear of the ThinPrep 2000 Processor, is in the “O” (Off) position. For “Off,” the top half of the toggle power switch is in the “out” position (protrudes).

2. Insert the power cord into the power receptacle located on the rear of the ThinPrep 2000 processor next to the power switch. Refer to Figure 2-5.

3. Connect the power cord to a 3-prong grounded outlet.

Turning the power on before instructed to do so can damage the instrument and inval-

Figure 2-5 Connecting the Power Cord

4. The ThinPrep 2000 processor is designed with an automatic line voltage detection feature. This feature eliminates the need to manually change the system line voltage setting to meet your specific requirements. The instrument will automatically adapt to any line voltage between 100– 120 VAC and 220–240 VAC.

Caution:

tor is available for diagnostic purposes only.

Caution:

2.8

ThinPrep 2000 Processor Operator’s Manual

Do not attach a cable to the 9-pin connector on the rear of the instrument. This connec-

The ThinPrep 2000 processor is fused internally. No user accessible fuse is available.

THINPREP 2000 INSTALLATION

SECTION

CYTYC ThinPrep

Version V#.##

Computed CRC: ####

Firmware CRC: ####

CYTYC ThinPrep

Initializing System

Press STOP to Cancel

TURNING ON YOUR THINPREP 2000 PROCESSOR

1. Confirm that the internal securements have been removed from the instrument before proceeding with this procedure. Refer to Section “INTERNAL PACKAGING REMOVAL” on page 2.2, for more information.

2. With the door to the ThinPrep 2000 processor closed, turn the toggle power switch, located on the right rear of the instrument, to the “1” (ON) position. For “On,” the top half of the toggle power switch is in the “in” position.

3. As the power is applied to the instrument, the control panel will display the following sequence of messages. If a different message appears in the display, follow the instructions on the control panel display or refer to Chapter 6, “Instrument Troubleshooting”, of this manual.

This message will appear for approximately four seconds:

At this point the system initializes all mechanisms while displaying this message for approximately four seconds:

ThinPrep 2000 Processor Operator’s Manual

2.9

THINPREP 2000 INSTALLATION

Pressure Sensor

calibration in

progress.

Please wait.

Main Menu: Select

1-SUPER 4-GYN

2-FLU/FNA

3-MUCOID

↓- MORE

After initialization, the system calibrates all pressure sensors while displaying this message for approximately twenty seconds:

If the system initialization and calibration were successful, the control panel display will read:

The above message indicates that the system is in idle mode.

4. Leave the power to the ThinPrep processor on all the time. It is not necessary to turn it off unless instructed to do so for troubleshooting or maintenance procedures.

5. The ThinPrep processor pressure sensor calibration occurs several times while the power is on:

•

at power up

•

15 minutes after power up

•

2 hours after power up

•

every 8 hours thereafter.

2.10

ThinPrep 2000 Processor Operator’s Manual

THINPREP 2000 INSTALLATION

SECTION

COMPLETE: NOTE

Sample is dilute

Please press ENTER

COMPLETE

Remove Filter

Remove Fix Bath

RUN A BLANK SAMPLE

When operating the ThinPrep 2000 processor for the first time, it is important to run a sequence using a blank PreservCyt Solution vial (no cells) to ensure that the system is fully functional. Read Chapter 5A, “Operating Instructions”, of this manual before proceeding with the procedure below.

1. Load a PreservCyt Solution vial (no cells) into the processor.

2. Attach a ThinPrep Pap test filter to the filter cap and load this assembly into the processor.

3. Load a ThinPrep slide into the processor.

4. Load an empty fixative vial into the processor.

5. Close the door.

6. Press key 4 to start the GYN sequence.

7. The instrument will now process the blank PreservCyt Solution vial.

8. Upon successful completion of the sequence, the slide will be in the fixative vial and the display will read:

If any other message is displayed, record the message and refer to Chapter 6, “Instrument Troubleshooting”, of this manual.

9. Press the ENTER key and following message appears:

10. Open the door.

11. Remove the filter cap and ThinPrep Pap test filter.

12. Remove the fixative vial containing the slide.

13. Remove the PreservCyt Solution vial.

ThinPrep 2000 Processor Operator’s Manual

2.11

THINPREP 2000 INSTALLATION

SECTION

14. The installation of the instrument is complete. The ThinPrep 2000 Processor is now ready for slide preparations. Read Chapter 7, “Maintenance”, of this manual before proceeding with additional slide preparations.

STORAGE AND HANDLING - POST INSTALLATION

During operation the ThinPrep 2000 processor is sensitive to vibrations. It should be placed on a sturdy bench away from centrifuges, vortexors or any other equipment that may cause vibrations.

Warning:

The fixative vial must be removed. Evaporating alcohol could create a fire hazard.

TURNING OFF THE THINPREP 2000 PROCESSOR

Turning the Instrument Off

If the instrument is to be turned off, unload any items in it (refer to page 5A.18.)

Press the power switch to the off position (“O” position).

Taking the Instrument Out of Service (Extended Shutdown)

If the instrument is to be shut down for an extended time, follow the instructions for turning off the Processor.

Completely remove power to the instrument by unplugging the power cord from the wall outlet.

2.12

ThinPrep 2000 Processor Operator’s Manual

3. PreservCyt

Solution

3. PreservCyt

PRESERVCYT SOLUTION

SECTION

Chapter Three

PreservCyt Solution

INTRODUCTION

The following sections describe the function and specifications of the cytologic preservative fluid,

PreservCyt

Solution.

ThinPrep 2000 Processor Operator’s Manual

3.1

PRESERVCYT SOLUTION

SECTION

WARNING:

PreservCyt Solution contains methanol. Danger. Poison. Vapor harmful. May be fatal or cause blindness if swallowed. Cannot be made non-poisonous. Keep away from fire, heat, sparks, and flame. Other solutions cannot be substituted for PreservCyt Solution.

PRESERVCYT® SOLUTION

PreservCyt Solution is a methanol-based, buffered solution designed to preserve cells during transport and slide preparation on the ThinPrep 2000 processor.

The ThinPrep processor slide preparation process also requires PreservCyt Solution for transporting and storing samples prior to processing. PreservCyt Solution is optimized for the ThinPrep processor slide preparation process and cannot be substituted with any other reagents.

Packaging

Please refer to the Ordering Information in this manual for part numbers and detailed information regarding the ordering of solutions and supplies for the ThinPrep 2000 system.

• Vials(20 mL) of PreservCyt Solution are contained in each ThinPrep Pap test.

Composition

PreservCyt Solution contains buffered methanol. It contains no reactive ingredients. It contains no active ingredients.

Storage Requirements

• Store PreservCyt Solution between 15°C (59°F) and 30°C (86°F). Do not use beyond the expiration date printed on the container.

with

• Store PreservCyt Solution 15°C (59°F) and 30°C (86°F) for up to 6 weeks.

• Store PreservCyt Solution Diagnostics COBAS AMPLICOR CT/NG test between 4°C (39°F) and 25°C (77°F) for up to 6 weeks.

• Storage requirements for quantities of PreservCyt Solution are dependent on local regulations regarding the size and configuration of your facility. Please refer to the Solutions Storage Guide at the end of this chapter.

3.2

ThinPrep 2000 Processor Operator’s Manual

cytologic sample intended for ThinPrep Pap testing between

with

cytologic sample intended for CT/NG testing using the Roche

PRESERVCYT SOLUTION

WARNING: See Package Insert Before

SPecimen Collection.

NAME:

ID#:

3256723-46

Line on cap and line on vial should meet or slightly overlap. If the cap on the vial does not have a line, ensure the cap is tightened securely.

Transportation

When transporting a PreservCyt Solution vial containing cells, make sure the vial is tightly sealed. Align the mark on the cap with the mark on the vial to prevent leakage as shown in Figure 3-1.

Figure 3-1 Aligning the Vial Cap

The shipping category for PreservCyt Solution is:

“flammable liquids, n.o.s. (methanol)” (USA only) “flammable liquids, toxic, n.o.s. (methanol) (outside the USA)

The shipping category for PreservCyt Solution containing cells is “diagnostic sample.”

Please refer to the Shipping Requirements and Recommendations guide at the end of this chapter.

Stability

Do not use PreservCyt Solution after the expiration date on the container label. If making multiple slides from the same sample vial, be sure to make the slides before the expiration date marked on the sample vial. Expired vials should be discarded using appropriate laboratory procedures. Also, refer to storage requirements (page 3.2) for cell preservation limits.

Handling/Disposal

Handle all chemical-containing materials carefully in accordance with safe laboratory practices. When required by reagent composition, additional precautions are marked on the reagent containers or in the instructions for use.

Dispose of PreservCyt Solution according to the guidelines for disposing of hazardous waste. PreservCyt Solution contains methanol.

ThinPrep 2000 Processor Operator’s Manual

3.3

PRESERVCYT SOLUTION

Organism Initial Concentration

Candida albicans

Aspergillus niger*

Escherichia coli

Staphylococcus aureus

Pseudomonas aeruginosa

Mycobacterium tuberculosis**

Rabbitpox virus

HIV-1

* After 1 hour >4.7 log reduction ** After 1 hour >5.7 log reduction *** Data is for 5 minutes

5.5 x 10

4.8 x 10

2.8 x 10

2.3 x 10

2.5 x 10

9.4 x 10

6.0 x 10

1.0 x 10

CFU/mL

PFU/mL

7.5

TCID50/mL

Log Reduction after

15 min.

>4.7

2.7

>4.4

4.9

5.5***

7.0***

Interfering Substances

The use of lubricants (e.g., KY Jelly) should be avoided prior to specimen collection. Lubricants can adhere to the filter membrane and may cause poor cell transfer to the slide. If its use is unavoidable, the lubricant should be used in minimum amounts.

3.4

ThinPrep 2000 Processor Operator’s Manual

ThinPrep®Solutions

(1)

StorageGuide

(2)





The National Fire Protection Association (NFPA) is the expert aut hority that local fire departments and fire safety code enforcement authorities look to for fire safety standards and codes. Their codes are developed through a consensus standards development process approved by the American National Standards Institute. The NFPA codes are used as guidelines by most fire code enforcement agencies. Since these codes are guidelines, your local Authority Having Jurisdiction (AHJ) for fire code enforcement may make the final determination. The summary chart below is based upon guidelines for facilities protected by standard sprinkler systems.

Use this chart to help you determine your maxi mum storage limits for flammable and combustible liquids.

Maximum Quantities of Flammable and Combustible Liquids in Laboratory Units Outside of Inside Liquid Storage Areas

Lab Unit

Fire

Hazard

Class

A (High)

(6)

(Moderate)

(7)

(Low)

(7)

(Minimal)

Flammable

& Combustible Liquid Class

I 45-2011 10 38 1900 480 1820 91,000 20 76 3800 480 1820 91,000

I, II, IIIA 45-2011 20 76 3800 800 3028 151,400 40 150 7500 1600 6060 303,000

I 45-2011 5 20 1000 300 1136 56,800 10 38 1900 480 1820 91,000

I, II, IIIA 45-2011 10 38 1900 400 1515 75,750 20 76 3800 800 3028 151,400

I 45-2011 2 7.5 375 150 570 28,500 4 15 750 300 1136 56,800

I, II, IIIA 45-2011 4 15 750 200 757 37,8520 8 30 1500 400 1515 75,750

I 45-2011 1 4 200 75 284 14,200 2 7.5 375 150 570 28,500

I, II, IIIA 45-2011 1 4 200 75 284 14,200 2 7.5 375 150 570 28,500

Maximum Quantities of PreservCyt Solution (Class IC) That Can Be Stored per Fire Area

General Warehouse Liquid Warehouse

(10)

30-2012 660 2500 124,900

(3,11)

30-2012 Unlimited Unlimited Unlimited

Office, to include Exam Rooms 30-2012 10 38 1890

Maximum allowable storage per ft2 in an inside storage room that is smaller than 150ft2 in size. 30-2012 5 19 946

Maximum allowable storage per ft2 in an inside storage room that is larger than 150ft2 and less than

(1) Solution classifications: PreservCyt – Class IC; CytoLyt – Class II; CellFyx – Class IB (2) This information is Hologic’s summary of the various regulations. To view the codes in their entirety, please refer to NFPA 30 and NFPA 45. (3) A Liquid Warehouse shall have a sprinkler system that complies with the appropriate system indicated in NFPA 30. (4) An Inside Liquid Storage Area is a storage room totally enclosed within a building and having no exterior walls. (5) A Laboratory Unit is the area surrounded by firewalls per NFPA 30 Flammable and Combustible Liquids Code. (6) Reduce quantities by 50% for B laboratory units located above the 3rd floor. (7) Reduce quantities by 25% for C and D laboratory units located on the 4th-6th floors of a building and reduce quantities by 50% for C and D laboratory units above the 6th floor (8) 20ml PreservCyt vials. (9) A Fire Area is the area of a building separated from the remainder of the building by construction having a fire resistance of at least 1-hour and having all communicating openings properly protected by an

assembly having a fire resistance rating of at least 1-hour per NFPA 30 Flammable and Combustible Liquids Code.

(10) Allowable quantities in a warehouse can be increased with a sprinkler system rated higher than standard systems. (11) A Liquid Warehouse is a separate, detached building or attached building used for warehousing-type operations for liquids.

(3)

Quantities in Use Quantities in Use and Storage

NFPA

Code

Max per 100ft2 of Lab

Unit

(5)

Gallons Liters Vials

Max Quantity per Lab

Unit

(8)

Gallons Liters Vials

Max per 100ft

(8)

Gallons Liters Vials

(9)

Outside a Safety Flammable Cabinet

Unit

(5)

of Lab

(8)

Gallons Liters Vials

Location NFPA Code Gallons Liters Vials

Allowable Quantities of PreservCyt Solution That Can Be Stored in a Liquid Storage Room

Location NFPA Code Gallons Liters Vials

500ft

in size.

30-2012 10 38 1892

(4)

Max Quantity per Lab

Unit

(8)

AW-05451-001 Rev. 002



Hologic Shipping Recommendations

Scope:

These recommendations include shipping:

 Biological specimens (patient specimens) in ThinPrep® solutions  Biological specimens in solutions other than ThinPrep  Biological specimens not in solutions  ThinPrep  ThinPrep

PreservCyt™ Solution without biological specimens

CytoLyt™ Solution without biological specimens

A. Shipping Biological Specimens in Solutions or Without Solutions

Notes:

1. When biological specimens are shipped in a solution of a quantity of 30 ml or less and are packed in accordance with these guidelines, no further requirements in the Hazardous Materials (Dangerous Goods) Regulations need be met. These requirements include training requirements. However, training is recommended.”

2. These recommendations for shipping biological specimens are valid, with the exception of private courier, for all modes of domestic and international transportation.

Definitions:

 Biological Substance, Category B: Materials containing or suspected to contain

infectious substances that do not meet Category A criteria. IATA Dangerous Goods regulations were revised on January 1, 2007. Note: The term “diagnostic specimen” has been replaced with “biological substance, Category B”

 Exempt specimens: specimens that with the minimal likelihood that pathogens are

present (fixed tissue, etc.)

Shipping Requirements Category B or Exempt2 – Ambient Temperature:

1. Packaging must consi st of three comp onents: a. a primary receptacle, leak proof b. secondary packagin g, leak proof c. a rigid outer packaging

NOTE: FedEx will not accept clinical samples or diagnostic specimens packaged in FedEx

envelopes, FedEx tubes, FedEx Paks, or FedEx Boxes.

2. The primary receptacle cannot contain more that 1L of a liquid substance (500 ml if using

FedEx).

3. If multiple fragile primary receptacles are placed in a single secondary packaging, they must be

either individually wrapped or separated to prevent contact between them.

* These instructions are Hologic’s interpretation of the various regulations as of the effective date. However, Hologic will not be responsible for any non-conformance to the actual regulations.

Page 1 P/N 85272-001 Rev G

solutions

4. Absorbent material must be placed between the primary receptacle and the secondary

packaging. The absorbent material (cotton balls, cellulose wadding, absorbent packets, paper towels) must be in sufficient quantity to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or the outer packaging.

5. The outer packaging must not contain more than 4L or 4kg of material. This quantity excludes

ice, dry ice, or liquid nitrogen when used to keep specimens cold.

6. An itemized list of contents must be enclosed between the secondary packaging and the outer

packaging.

7. The packaging must successfully pass a 4 ft. drop test (Section 6.6.1 IATA regulations).

8. The UN3373 mark must be displayed on the external surface of the outer packaging (one

surface of the outer packaging must have a minimum dimension of 100 mm x 100 mm FedEx minimum is 7”x 4”x 2”) on a background of a contrasting color and must be clearly visible and legible. The mark must be in the form of a diamond with each side having a length of at least 50 mm. Lettering must be at least 6mm high.

9. The proper shipping name “Biological Substance, Category B” in letters at least 6mm high must

be marked on the outer package adjacent to the diamond shaped UN3373 mark.

10. If using FedEx, the FedEx USA Airbill, Section 6, Special Handling must be completed with

Does this shipment contain dangerous goods?

Shipping Requirements Category B or Exempt

NOTE: FedEx defers to IATA regulations for the shipping of refrigerated or frozen diagnostic specimens.3

Follow all packaging directions for Category B or Exempt – Ambient Temperature plus:

1. Place ice or dry ice outside of the secondary packaging. Interior supports must be provided to secure

dangerous goods/dry ice information:



YES- Shipper’s Declaration not required

11. The outer container of all diagnostic/clinical specimen packages must display the following: a. Sender’s name and ad dress

b. Recipient’s name and address c. The words “Biological Substance, Category B” d. The UN 3373 label

– Frozen or Refrigerated Specimens:

the secondary packaging in the original position after the ice or dry ice has dissipated. If ice is used, the outside packaging or overpack must be leak proof. If dry ice is used, the packaging mu st be designed and constructed to permit the release of CO

gas to prevent a buildup of pressure that could

rupture the packaging.

Page 2 P/N 85272-001 Rev G

2. Always affix the Class 9, UN 1845 dry ice label as well as the UN 3 373, Biological Substance, Category B label to these shipments

3. If using FedEx, the FedEx USA Airbill, Section 6, Special Handling must be completed with dangerous goods/dry ice information:

Does this shipment contain dangerous goods?



YES- Shipper’s Declaration not required



Enter kg of dry ice used (if applicable)

4. The outer container of all diagnostic/clinical specimen packages must display the following:

a. Sender’s name and ad dress b. Recipient’s name and address c. The words “Biological Substance, Category B” d. The UN 3373 label e. Class 9 label, including UN 1845, and net weight if packaged with dry ice

B. Shipping ThinPrep

PreservCyt™ Solution Only (such as from a laboratory to a physician)

Domestic Ground Shipments - Limited Quantities:

Notes: ThinPrep

PreservCyt™ Solution is classified as a Class 3 Flammable liquid, assigned to Packing

Group III (PG III). 49 CFR 173.150 (Limited Quantities) allows ThinPrep

PreservCyt™ Solution in vials to be shipped in Limited Quantities when shipped via ground transportation in a sturdy box. The total volume in a package cannot exceed 5 liters or weigh more than 30 kg (66 lbs). Limited Quantities are exempt from labeling requirements.

Limited Quantity domestic ground shipping recommendations:

1. ThinPrep

PreservCyt™ Solution must be shipped in the vials.

2. Place the vials in a good quality cardboard box, such as the ThinPrep® box that holds 250 vials. Pack vials in a manner (adding protective packing material as necessary) as to limit movement of individual vials.

3. Mark the package as “Flammable liquids, n.o.s., (M ethanol Solution), 3, UN1993, Ltd. Qty.” and add orientation arrows on the ends.

4. Print “UN1993, Flammable liquids, n.o.s., (Methanol Solution), 3, PGIII, Ltd. Qty.” on the Shipping papers.

Domestic Ground Shipments - Other than Limited Quantities: When shipping packages in excess of “Limited Quantity” amounts:

1. Do not include “Ltd Qty” in the wording on the package or on the Shipping papers as indicated in c and d above.

2. Affix a Class 3 “Flammable Liquid” h azard label to the outer package in close proximity of the wording described in “c” above. See the example of the label on the last page of these recommendations.

Page 3 P/N 85272-001 Rev G

Domestic Air Shipments:

In addition to 1 and 2 above in Domestic Ground Shipments – Other than Limited Quantities, the following are recommendations for domestic air shipments:

3. Maximum allowable package sizes are:

i. Sixty (60) liters (3000-vials) for passenger aircraft, and

ii. Two hundred twenty (220) liters (11,000-vials) for cargo aircraft.

4. Single packages contai ning more than sixty (60) liters (3000-vials) of total product must be

clearly marked “FOR CARGO AIRCRAFT ONLY”.

5. The vials must be shipped in United Nations (UN) certified 4G packaging for any quantity in

an aircraft. (e.g., ThinPrep

PreservCyt™ Solution 250-vial box or equivalent.)

6. A Class 3 “Flammable Liquid” label must be affixed to the outer package near the words

“Flammable liquids, n.o.s., (Methanol Solution)”.

7. It is voluntary to place an “Air Eligibility” label (an airplane in a circle) adja ce nt to the words

“Flammable liquids, n.o.s., (Methanol Solution)”.

All Domestic Shipments: The following are recommendations for all domestic ground and air shipments:

1. If the ThinPrep

material, the hazardous material must be listed first, or be printed in a contrasting color (or highlighted) to differentiate it from the non-hazardous material.

2. The total volume of ThinPrep® PreservCyt™ Solution and the number of vials must appear on

the shipping papers.

International Ground Shipments - Limited Quantities:

When shipping internationally, ThinPrep Class 3 (Flammable Liquid), and with a secondary hazard of Class 6.1 (Toxic). It is assigned to PG III.

The reference used for the international ground recommendations is the ADR - European Agreement Concerning the International Carriage of Dangerous Good by Road (United Nations). A “Limited Quantity” is defined as a package containing a maximum net quantity of 5-liters and not weighing more than 20 kg (40 lbs). The recommendations for international ground shipments are as follows:

1. ThinPrep® PreservCyt™ Solution must be shipped in the vials.

2. Place the vials in a good quality cardboard box, such as the Cytyc box that holds 250 vials.

Pack vials in a manner (adding protective packing material as necessary) as to limit movement of individual vials.

3. Mark the package with “UN1992, Flam mable liquids, toxic, n.o.s., (Methanol Solution), 3, 6.1,

PGIII Ltd. Qty” and add orientation arrows on the ends.

4. The shipping papers should include all the information indicated in “3” above.

International Ground Shipments – Other then Limited Quantities:

1. Do not include “Ltd Qty” in the wording on the package or on the Shipping papers as

indicated in c and d above.

2. Affix both a Class 3 “Flammable Liquid” label and a secondary Class 6.1 “Toxic” label to the

package adjacent to the markings indicated in paragraph “3” above. Copies of the labels ca n be found on the last page of these recommendations.

Page 4 P/N 85272-001 Rev G

PreservCyt™ Solution is shipped in a package also containing non-hazardous

PreservCyt™ Solution is classified with a primary hazard of

International Air Shipments:

The references used for the International Air recommendations are: In addition to a and b above in International Ground Shipments, the following are the recommendations for international air shipments:

1. Maximum allowable package sizes are:

i. Sixty (60) liters (3000-vials) for passenger aircraft, and

ii. Two hundred twenty (220) liters (11,000-vials) for cargo aircraft.

2. Packages containing more than sixty (60) liters of product must be clearly marked “FOR

CARGO AIRCRAFT ONLY”

3. The vials must be shipped in United Nations (UN) certified 4G packaging for any quantity in

an aircraft. (e.g., ThinPrep

PreservCyt™ Solution 250-vial box or equivalent.) Pack vials in a manner (adding protective packing material as necessary) as to limit movement of individual vials.

4. Limited Quantity exemption can only be used if the package has a maximum net quantity of 2-liters.

5. Packaging manufacturer’s specifications markings are not required when shipping Limited Quantity.

6. It is optional to place an ”Air Eligibility” label (an airplane in a circle) adjacent to the words “Flammable liquids, toxic, n.o.s. (Methanol Solution)”.

7. When a “Cargo Aircraft Only” marking is required, it must be affixed on the same package surface and near the hazard labels.

8. The shipper is responsible for the completion of a “Shipper’s Declaration for Dangerous Goods” form.

C. Shipping ThinPrep® PreservCyt™ Solution With Patient Sample (e.g. physician to a laboratory)

Notes:

1. This method of shipping patient samples is an alternative method to the method detailed in Section A of this document.

2. US DOT Hazard Material Employee training (49 CFR 172.700) is required if you use this method of shipment.

Risk Group 1 samples are those which contain pathogens under such conditions that their ability to produce disease is very low to none. An independent laboratory challenged ThinPrep

PreservCyt™ Solution with a variety of microbial and viral organisms. The organisms became non-viable after 15minutes in the solution. This challenge allows you to place a patient sample in ThinPrep

PreservCyt

Domestic (U.S.) Shipments:

™

Solution into the Risk Group 1 classification.

Follow the appropriate U.S. DOT regulations for shipping Risk Group 1 Biological Substances, Category B (49 CFR 173.134).

These regulations do not apply when the specimens are transported by a private or contract carrier in a motor vehicle used exclusively to transport diagnostic specimens.

International Shipments:

Follow the appropriate IATA, ADR, or country specific regulations for shipping Risk Group 1

D. Shipping ThinPrep® CytoLyt™ Solution Only (such as from a laboratory to a physician)

diagnostic specimens.

Domestic Ground Shipments:

ThinPrep® CytoLyt™ Solution has a flash point of 109° F. For domestic ground transportation only, a flammable liquid with a flashpoint at or above 100° F that does not meet the definition of any other

hazard class may be reclassed as a combustible liquid. As such, ThinPrep shipped via ground, is exempt from the requirements of the DOT Hazardous Materials Regulations.

CytoLyt™ Solution,

Page 5 P/N 85272-001 Rev G

Domestic Air Shipments:

When shipping ThinPrep® CytoLyt™ Solution via air, follow the Domestic Air Shipments recommendations for Shipping ThinPrep

PreservCyt™ Solution Only that can be found in Section B

of this document.

International Ground and Air shipments:

When shipping ThinPrep® CytoLyt™ Solution via ground or air, follow the International Ground or Air

Shipments recommendations for Shipping ThinPrep be found in Section B of this document.

PreservCyt™ Solution Only guidelines that can

E. Shipping ThinPrep® CytoLyt™ Solution With Patient Sample (such as from a physician to a

laboratory) Domestic Shipments:

ThinPrep® CytoLyt™ Solution containing a patient sample is classified as a Biological Substance, Category B. Follow the recommendations in Section A of this document.

International Shipments:

ThinPrep® CytoLyt™ Solution containing a patient sample is classified as a Biological Substance, Category B. Follow the recommendations in Section A of this document.

Class 3 “Flammable liquid” primary hazard label.

Class 6.1 “Toxic” secondary hazard label.

References:

 49 CFR 100 to 185, Transportation  International Air Transport Association’s (IATA’s) Dan gerous Good Regulations, 49

Edition, 2008, International Air Transportation Association (IATA)

 International Civil Aviation Organization’s (ICAO’s) Technical Instructions for the Safe

Transport of Dangerous Goods by Air),

Foot Notes:

1. www.IATA.org/whatwedo/cargo/dangerous_goods/faq.htm

2. IATA Packing Instruction 650, http://www.iata.org/NR/rdonlyres/C993126E-9AAF-4498-B76E-

583B3D774F90/0/DGR_48_PI650.pdf

3. Pointers on Shipping: Clinical Samples, Diagnostic Specimens, and Environmental Test Samples, Document 3489FE, FedEx

Page 6 P/N 85272-001 Rev G

Sample Preparation

4. Gynecologic

4. Gynecologic Sample Preparation

GYNECOLOGIC SAMPLE PREPARATION

SECTION

ThinPr

Chapter Four

Gynecologic Sample Preparation

INTRODUCTION

Includes cell samples from the ectocervix and the endocervix.

1. Collection: Deposit the specimen directly into a PreservCyt Solution vial.

2. Allow to stand in PreservCyt Solution for 15 minutes

3. Run on ThinPrep and Evaluate

2000 processor using Sequence 4, Fix, Stain,

ThinPrep 2000 Processor Operator’s Manual

4.1

GYNECOLOGIC SAMPLE PREPARATION

SECTION

COLLECTION PREPARATION

ThinPrep Collection Techniques

The detection of cervical cancer and its precursors as well as other gynecologic abnormalities is the primary purpose of obtaining a cervical cell sample. The following guidelines are referenced

from NCCLS Document GP15-A3 a ThinPrep Pap Test (TPPT) specimen. In general, the guidelines state that it is important to obtain a specimen that is not obscured by blood, mucus, inflammatory exudate or lubricant.

Patient Information

• The patient should be tested 2 weeks after the first day of her last menstrual period, and definitely not when she is menstruating.

Even though the TPPT reduces obscuring blood, clinical studies have demonstrated that excessive amounts of blood may still compromise the test and possibly lead to an unsat-

isfactory result.

and are recommended in the collection process for obtaining

• The patient should not use vaginal medication, vaginal contraceptives, or douches during the 48 hours before the exam.

Specimen Collection Preparation

• Lubricant jellies should not be used to lubricate the speculum.

Even though lubricant jellies are water soluble, excessive amounts of jelly may compromise the test and possibly lead to an unsatisfactory result.

• Remove excess mucus or other discharge present before taking the sample. This should be gently removed with ring forceps holding a folded gauze pad.

The excess cervical mucus is essentially devoid of meaningful cellular material and when present in the sample vial may yield a slide with little or no diagnostic material present.

• Remove inflammatory exudate from the cervical canal before taking the sample. Remove by placing a dry 2 x 2 inch (5 x 5 cm) piece of gauze over the cervix and peeling it away after it absorbs the exudate or by using a dry proctoswab or scopette.

The excess inflammatory exudate is essentially devoid of diagnostic cellular material and when present in the sample vial may yield a slide with little or no diagnostic material present.

• The cervix should not be cleaned by washing with saline or it may result in a relatively acellular specimen.

• The sample should be obtained before the application of acetic acid.

1. Papanicolaou Technique Approved Guidelines (NCCLS Document GP15-A3)

2. Lee et al. Comparison of Conventional Papanicolaou Smears and Fluid-Based, Thin-Layer

System for Cervical Cancer Screening. Ob Gyn 1997; 90: 278-284.

4.2

ThinPrep 2000 Processor Operator’s Manual

GYNECOLOGIC SAMPLE PREPARATION

SECTION

SPECIMEN COLLECTION

Collect Gynecologic Sample Using the Broom-Like Device

Physician/clinician instructions for collecting gynecologic samples.

Obtain

device. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently, and rotate the broom in a clockwise direction five times.

Rinse

tion vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. As a final step, swirl the broom vigorously to further release material. Discard the collection device.

an adequate sampling from the cervix using a broom-like

the broom as quickly as possible into the PreservCyt Solu-

Tighten

torque line on the vial.

Record

ogy request form.

Note:

Place

the laboratory.

the cap so that the torque line on the cap passes the

the patient’s name and ID number on the vial.

the patient information and medical history on the cytol-

If the sample is to be processed immediately, allow the sample to stand in the PreservCyt Solution vial for at least 15 minutes before processing.

If the sample is to be sent elsewhere for processing, continue with the next step.

the vial and requisition in a specimen bag for transport to

ThinPrep 2000 Processor Operator’s Manual

4.3

GYNECOLOGIC SAMPLE PREPARATION

Collect Gynecologic Sample, Using the Endocervical Brush/Spatula Device

Physician/clinician instructions for collecting gynecologic samples.

Obtain

spatula.

Rinse

Solution vial by swirling the spatula vigorously in the vial 10 times. Discard the spatula.

an adequate sampling from the ectocervix using a

the spatula as quickly as possible into the PreservCyt

plastic

Obtain

3. endocervical brush device. Insert brush into the cervix until only the bottom-most fibers are exposed. Slowly rotate 1/4 or 1/2 turn in one direction. DO NOT OVER-ROTATE.

Rinse

4. by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall. Swirl vigorously to further release material. Discard the brush.

Tighten

5. torque line on the vial.

Record

ogy requisition form.

Note:

an adequate sampling from the endocervix using an

the brush as quickly as possible in the PreservCyt Solution

the cap so that the torque line on the cap passes the

the patient’s name and ID number on the vial.

the patient information and medical history on the cytol-

If the sample is to be processed immediately, allow the sam-

ple to stand in the PreservCyt Solution vial for at least 15 minutes before processing.

If the sample is to be sent elsewhere for processing, continue with the next step.

Place

the vial and requisition in a specimen bag for transport to

the laboratory.

4.4

ThinPrep 2000 Processor Operator’s Manual

SPECIAL PRECAUTIONS

SECTION

PreservCyt Solution

After sample transfer to the PreservCyt Solution vial, the sample should stand for at least 15 minutes before processing.

GYNECOLOGIC SAMPLE PREPARATION

For more information on PreservCyt Solution, refer to Chapter 3, “PreservCyt Solution”

Interfering Substances

The Clinical and Laboratory Standard Institute Guidelines (formerly NCCLS) recommend that no lubricant be used during Pap testing.

ACOG recommends that care be taken not to contaminate the specimen with lubricant because this may lead to unsatisfactory results.

and liquid-based cytology.

If you are using a plastic speculum, or in instances where a lubricant must be used, take care not to contaminate the cervix or collection devices with the lubricant. A tiny amount of lubricant may be used, just enough to sparingly coat the speculum with a gloved finger, avoiding the tip of the speculum.

The Clinical and Laboratory Standard Institute Guidelines and ACOG recommend that you not take a Pap during menses.

For samples to be processed on the ThinPrep 2000 processor, lubricants can adhere to the filter membrane and may cause poor cell transfer to the slide. If its use is unavoidable, the lubricant should be used in minimum amounts.

1-2

This applies to both conventional Pap testing

Papanicolaou Technique Approved Guidelines (CLSI Document GP15-A3, third edition, 2008)

ACOG Practice Bulletin, no. 45, August 2003

ThinPrep 2000 Processor Operator’s Manual

4.5

GYNECOLOGIC SAMPLE PREPARATION

SECTION

ID#

00001168

Frosted area

Handling/Disposal

Handle all chemical-containing materials carefully in accordance with safe laboratory practices. When required by reagent composition, additional precautions are marked on the reagent containers.

Dispose of PreservCyt Solution according to your guidelines for disposing of hazardous waste. PreservCyt Solution contains methanol.

SPECIMEN PROCESSING

Materials Required

Refer to Materials Required sections on page 1.5 and page 5A.4 for a list and explanation of materials provided and materials required but not provided.

Specimen Preparation

• The gynecologic sample should be deposited in the PreservCyt Solution immediately upon collection.

• The PreservCyt Sample vial fluid level should be within the frosted area of the sample vial.

Figure 4-1 PreservCyt Sample Vial Fluid Level

• Store PreservCyt Solution 15°C (59°F) and 30°C (86°F) for up to 6 weeks.

with

cytologic sample intended for ThinPrep Pap testing between

4.6

ThinPrep 2000 Processor Operator’s Manual

GYNECOLOGIC SAMPLE PREPARATION

ThinPr

SECTION

Run On ThinPrep 2000 Processor Using Sequence 4, Fix, Stain, and Evaluate

The operator loads the instrument and selects sequence number 4 for the sample to be processed as described in Chapter 5A, “Operating Instructions”. At the completion of the process, the operator fixes and stains the slide according to the procedure in Chapter 8, “Fixation, Staining, and Coverslipping”.

Stability

Store PreservCyt Solution (59°F) and 30°C (86°F) for up to 6 weeks.

with

cytologic sample intended for ThinPrep Pap testing between 15°C

Sample Processing Troubleshooting

REPROCESSING A THINPREP PAP TEST SAMPLE VIAL FOLLOWING AN UNSATISFACTORY RESULT

Laboratory personnel may reprocess ThinPrep Pap test specimens where slides have been interpreted as inadequate (“Unsatisfactory for Evaluation”) for diagnosis following cytotechnologist screening. The instructions below must be followed in order to properly reprocess these specimens:

Note:

Reprocessing a ThinPrep Pap test specimen may only be performed once.

Good laboratory practices should be followed to avoid introducing contaminants into the

PreservCyt Solution sample vial.

ThinPrep 2000 Processor Operator’s Manual

4.7

GYNECOLOGIC SAMPLE PREPARATION

30 ml

Reprocessing Protocol

1 Prepare a wash solution of sufficient volume to add 30 mL to every

ThinPrep Pap test specimen being reprocessed. The wash solution is made by mixing 9 parts CytoLyt Solution with 1 part glacial acetic acid.

2 Prior to performing this step, assure there is sufficient volume in the

ThinPrep Pap test specimen to result in a pellet, following centrifugation. Pour the contents of the ThinPrep Pap test specimen into a centrifuge tube appropriately labeled to maintain chain of custody. Retain the vial.

3 Pellet the contents of the centrifuge tube by centrifugation at 1200 x

for 5 minutes.

Note:

Once centrifugation is complete, the cell pellet should be

clearly visible but the cells may not be tightly packed together (the pellet may appear fluffy).

4 a. Carefully pour off the supernatant from the centrifuge tube to

avoid loss of cells. Dispose of according to local regulations.

b. Vortex the centrifuge tube briefly.

c. Pour 30 mL of the CytoLyt Solution and 10% glacial acetic acid

mixture into the centrifuge tube and cap securely.

d. Invert the centrifuge tube by hand several times to mix.

5 Pellet the cells again by centrifugation — 1200 x

for 5 minutes.

4.8

ThinPrep 2000 Processor Operator’s Manual

GYNECOLOGIC SAMPLE PREPARATION

6 a. Carefully pour off the supernatant from the centrifuge tube to

avoid loss of cells. Dispose of according to local regulations.

b. Vortex the centrifuge tube briefly.

7 a. Using the volume markings on the centrifuge tube, pour the nec-

essary quantity of unused (i.e., containing no patient specimens) PreservCyt Solution to the cells and fill to a final volume of 20 mL. Secure the cap tightly.

b. Invert the centrifuge tube several times to mix and transfer the

sample back into the retained specimen vial.

8 Process the specimen using a ThinPrep 2000 processor according to

the procedure for running gynecologic specimens. Evaluate the resultant slide according to

Vaginal Cytologic Diagnosis

from specimen do not fit with the clinical impression, a new specimen may be necessary.

The Bethesda System for Reporting Cervical/

. If after reprocessing, negative results

ThinPrep 2000 Processor Operator’s Manual

4.9

GYNECOLOGIC SAMPLE PREPARATION

This page intentionally left blank.

4.10

ThinPrep 2000 Processor Operator’s Manual

5. Operating

Instructions

5. Operating

Chapter Five A

SECTION

Operating Instructions

OPERATING INSTRUCTIONS

Note:

Specific processing steps must be followed before and during use of the ThinPrep® 2000 processor if planning to perform

testing, using the Roche Diagnostics COBAS ual specimen after a slide has been prepared using the ThinPrep 2000 processor. Follow the procedures found in Chapter 5B of the ThinPrep 2000 Operator's Manual.

Chlamydia trachomatis

AMPLICOR™ CT/NG test, on the resid-

and

Neisseria gonorrhoeae

INTRODUCTION

This section provides instructions for operating the ThinPrep® 2000 processor.

The following topics are covered in this section:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

Optional Instructions for Ancillary Testing 5A.2

Material Requirements 5A.4

Pre-Operation Checklist 5A.5

Overview of Loading the ThinPrep 2000 Processor 5A.6

Loading the PreservCyt® Sample Vial 5A.7

SECTION G:

SECTION H:

SECTION I:

SECTION J:

SECTION K:

SECTION L:

SECTION M:

SECTION N:

Loading the ThinPrep Pap Test Filter 5A.8

Loading the ThinPrep Microscope Slide 5A.11

Loading the Fixative Vial 5A.14

Closing the Door 5A.15

Selecting and Initiating a Sequence 5A.16

Unloading the ThinPrep 2000 Processor 5A.18

Interrupting the Slide Preparation Process 5A.20

Status, Maintenance, and Test Screens 5A.21

ThinPrep 2000 Processor Operator’s Manual

5A.1

5A5A

OPERATING INSTRUCTIONS

SECTION

OPTIONAL INSTRUCTIONS FOR ANCILLARY TESTING

Testing for certain sexually transmitted diseases (STD) and for Human Papilloma Virus (HPV) in conjunction with cytology may be performed using the residual specimen remaining in the PreservCyt sample vial after preparation of the ThinPrep Pap test slide. Such testing may also be enabled by the removal of an aliquot of up to 4 mL (Aliquot Removal) from the PreservCyt sample vial before preparing the ThinPrep Pap test slide.

Laboratory personnel must follow the specific instructions in this section to appropriately remove the desired aliquot volume and prepare the PreservCyt sample vial for the ThinPrep Pap test. Adherence to these instructions must be maintained to ensure there is no adverse effect on the ThinPrep Pap test result.

Because cytology/HPV testing and STD testing address different clinical questions, Aliquot Removal may not be suitable for all clinical situations. Physicians and other persons responsible for ordering clinical tests should be familiar with the following:

• There is no evidence of degradation of cytology results by Aliquot Removal, however, this cannot be ruled out for all specimens. As with any subsampling step in anatomic pathology, chance misallocation of diagnostic cells may occur if they are very rare. If negative results from the specimen do not fit with the clinical impression, a new specimen may be necessary.

• Aliquot Removal from low-cellularity specimens may leave insufficient material in the PreservCyt sample vial for preparation of a satisfactory ThinPrep Pap test slide.

• Aliquot Removal may leave insufficient material in the PreservCyt sample vial for performance of ancillary testing (e.g., reflexive HPV testing) using the residual specimen following preparation of a ThinPrep Pap test slide.

• Co-collection of separate samples for the ThinPrep Pap test and STD testing may be considered in lieu of Aliquot Removal.

• When opting for concurrent cytologic and STD testing, providers should consider risk and clinical history (e.g., disease prevalence, patient age, sexual history or pregnancy) as well as specimen suitability (e.g., exudates or bleeding) that can impact diagnostic reliability.

Sexually Transmitted Diseases Treatment Guidelines 2002 (Centers for Disease Control and Prevention, MMWR 2002: 51(No. RR-6)) provides clinical guidance for the management and treatment of individual patients, including use of Pap testing.

It is essential that the instructions in Chapter 5B be followed if the Roche Diagnostics COBAS AMPLICOR™ CT/NG test will be performed using the residual specimen after prepared using the ThinPrep 2000 processor.

a slide has been

5A.2

ThinPrep 2000 Processor Operator’s Manual

OPERATING INSTRUCTIONS

Removing an Aliquot (of up to 4 mL) from the PreservCyt Sample Vial prior to performing the ThinPrep Pap Test

Note:

Only one aliquot may be removed from the PreservCyt sample vial prior to performing the

ThinPrep Pap test, regardless of the volume of the aliquot (maximum aliquot volume = 4 mL).

Note:

1. Vortex the vial at high speed for 8 to 12 seconds.

CAUTION:

homogeneity of the sample.

2. Carefully remove the vial cap.

3. Using a pipetting device, withdraw an aliquot of up to 4 mL from the vial. Take care to avoid

4. Dispense the aliquot into a suitably sized and labeled polypropylene tube and close tightly to

5. Store the aliquot under conditions appropriate for ancillary test(s). Refer to manufacturer or lab-

6. Dispose of the pipetting device in accordance with local, state, and federal regulations.

7. Using a new pipetting device, withdraw a quantity of unused Preservcyt Solution from its con-

8. Transfer the volume of unused PreservCyt Solution to the vial from which the aliquot was

9. Secure the vial cap. (The line on the cap and line on the vial should meet or slightly overlap.)

10. Dispose of the pipetting device in accordance with local, state, and federal regulations.

11. Refer to the remaining steps in this chapter to complete the ThinPrep Pap test.

Good laboratory practices should be followed to avoid introducing contaminants into either

the PreservCyt sample vial or the aliquot. It is recommended to use powder-free gloves and an individually wrapped, disposable pipetting device with an aerosol barrier tip that is sized appropriately for the volume being withdrawn and dispensed. You should not use serological pipettes. In order to minimize the potential for cross-contamination, aliquot removal should be performed in an appropriate location outside an area where amplification is performed.

The desired aliquot must be removed immediately after vortexing the vial to ensure

contaminating gloves with solution. If gloves should become contaminated, replace with a clean pair before proceeding to the next specimen.

prevent leakage/evaporation.

oratory instructions for performing ancillary test(s) on the aliquot.

tainer that is equal in volume to that of the aliquot removed from the vial in step 3.

removed in step 3.

ThinPrep 2000 Processor Operator’s Manual

5A.3

5A5A

OPERATING INSTRUCTIONS

SECTION

PreservCyt

Solution

Fixative

vial

Operator’s manual

Gloves

Lint-free wipes

Filter cap

ThinPrep

microscope slide

Sta ining rack

and alcohol bath

ThinPrep Pap

test filter

MATERIAL REQUIREMENTS

Figure 5A-1 The Required Materials

The

PreservCyt Solution

that preserves cells from all body sites for up to three weeks at room temperature. For more information on PreservCyt Solution, refer to Chapter 3, “PreservCyt Solution”.

The

ThinPrep Pap test tilter

membrane bonded onto the other end. The filter membrane has a flat, smooth, porous surface.

The

filter cap

the ThinPrep Pap test filter into the processor.

fixative vial

The the ThinPrep processor transfers cells onto the slide, it automatically ejects the slide into the fixative vial.

The

ThinPrep microscope slide

screening area and a larger labeling area. The slide is specifically designed for use with the ThinPrep processor.

Supplies

for the ThinPrep 2000 processor. These include PreservCyt Solution vials for use with the ThinPrep

5A.4

ThinPrep 2000 Processor Operator’s Manual

is a plastic cap that fits onto the open end of the ThinPrep Pap test filter and mounts

is a plastic vial that should be filled with standard laboratory fixative alcohol. After

used in the ThinPrep 2000 system are those designed and supplied by Hologic specifically

vial is a plastic vial that contains an alcohol-based preservative solution

is a disposable plastic cylinder that is open at one end and has a filter

is a high-quality, pre-cleaned glass microscope slide with a defined

OPERATING INSTRUCTIONS

SECTION

Pap test, Gyn ThinPrep Pap test filters (clear), and ThinPrep microscope slides. For gynecologic use, these supplies are required for proper performance of the system and cannot be substituted with any other items. Product performance will be compromised if other supplies are used. After use, supplies should be disposed of in accordance with local, state, and federal regulations.

The

ThinPrep 2000 System Operator’s Manual

ThinPrep 2000 System, such as the principles of operation, operating instructions, specifications, and maintenance information. The manual also contains information on the solutions and materials required to prepare slides with the ThinPrep 2000 Processor.

contains detailed information about the

Disposable laboratory gloves

Lint-free wipes

Alcohol bath

with slide staining rack and standard laboratory fixative alcohol.

— non-powdered gloves are recommended.

PRE-OPERATION CHECKLIST

The following conditions should be checked before preparing a slide on the ThinPrep 2000 processor.

• Waste bottle — Make sure the fluid level of the waste bottle is below the “MAX” fill line of the bottle. Refer to “EMPTYING WASTE BOTTLE” on page 7.2, for emptying instructions.

• Idle mode — Confirm that the instrument is powered on and in idle, or Main Menu, mode. If the Main Menu is not displayed, follow the instructions on the display until the idle mode appears. If the system’s power is off, refer to Chapter 2, “ThinPrep 2000 Installation”, for turning system power on.

• Filter seal O-rings — Make sure that the two O-rings at the base of the filter cap are not dry, cracked, or in need of lubrication. Refer to Chapter 7, “Maintenance”, for lubrication and/or replacement instructions.

• Disposable laboratory gloves — Always wear disposable laboratory gloves and other lab safety garments when operating the ThinPrep processor.

Note

: Once sample has been added to a PreservCyt

PreservCyt sample vial

Solution

ThinPrep 2000 Processor Operator’s Manual

vial, the vial is then designated as a

5A.5

5A5A

OPERATING INSTRUCTIONS

SECTION

Slide handler/ejector

Fixative vial

Fixative bath holder

Cap seal

Bobbins

Filter assembly

PreservCyt sample vial

Sample vial holder

Slide

OVERVIEW OF LOADING THE THINPREP® 2000 PROCESSOR

The next four sections describe in detail the methods for loading the ThinPrep 2000 processor. The following supplies must be loaded into the processor before initiating a sample run:

• PreservCyt sample vial

• ThinPrep Pap test filter

• ThinPrep microscope slide

• Fixative vial

The figure below shows the ThinPrep 2000 processor after loading of the supplies is complete.

Figure 5A-2 ThinPrep 2000 Processor Loaded with Supplies

5A.6

ThinPrep 2000 Processor Operator’s Manual

OPERATING INSTRUCTIONS

SECTION

Sample holder

LOADING THE PRESERVCYT SAMPLE VIAL

1. Open the ThinPrep 2000 processor door by gripping the door tab and sliding it gently to the right until it is completely open.

2. Confirm that the sample holder, fixative vial holder, and slide handler are empty.

3. Remove the cap from the PreservCyt sample vial.

4. Gently place the PreservCyt sample vial into the sample holder until the bottom of the vial rests on the sample holder base. Refer to Figure 5A-3.

5. The vial will remain loose in the sample holder until the process begins. The instrument will automatically grasp the vial during processing.

Figure 5A-3 Loading the PreservCyt Sample Vial

ThinPrep 2000 Processor Operator’s Manual

5A.7

5A5A

OPERATING INSTRUCTIONS

SECTION

Method B

Method A

LOADING THE THINPREP PAP TEST FILTER

1. Remove a new ThinPrep Pap test filter from the storage tray by grasping the sides of the cylinder.

Caution:

2. There are two different techniques for mating the ThinPrep Pap test filter and filter cap. This configuration of the two parts is called a filter assembly.

Note:

Handle the filter cap gently. Do not hit it against hard surfaces.

Never touch the filter membrane of the ThinPrep Pap test filter.

Method A:

Hold the filter cap in the palm of one hand and the ThinPrep Pap test filter in the other hand as shown in Figure 5A-4. Insert the ThinPrep Pap test filter.

Method B:

Place the filter cap on the bench and hold the ThinPrep Pap test filter in one hand. Insert the ThinPrep Pap test filter.

Using a slight twisting motion with either method will prevent unwanted O-ring roll. The filter seal O-rings should be lightly greased. Refer to “FILTER CAP O-RING LUBRICATION” on page 7.5.

Figure 5A-4 Assembling the Filter Cap and Filter

3. Ensure there is no visible gap between the ThinPrep Pap test filter and the filter cap as shown in Figure 5A-5.

The ThinPrep Pap test filter must seat against the filter cap lip.

5A.8

ThinPrep 2000 Processor Operator’s Manual

Figure 5A-5 Correct Filter Cap-to-Filter Assembly

Correct Incorrect

No gap

Gap

ThinPrep Pap test filter

4. Insert the filter assembly into the instrument.

OPERATING INSTRUCTIONS

Hold the filter assembly by the ThinPrep Pap test filter cylinder and place the angled edges of the filter cap against the two front bobbins as shown in Figure 5A-6.

Figure 5A-6 Positioning the Filter Cap in the Bobbins

5. Keeping the filter assembly level, push it straight into the instrument. The right bobbin will move to the right as the filter assembly is inserted. The filter assembly is completely seated when the right bobbin moves back to the left and the two front bobbins hold the filter assembly in the processor. Refer to Figure 5A-7.

When properly loaded, the filter cap is level inside the instrument and the filter cylinder is above the PreservCyt sample vial and slightly to the left. If the positioning of the filter assembly does

ThinPrep 2000 Processor Operator’s Manual

5A.9

5A5A

OPERATING INSTRUCTIONS

Bobbins

not correspond to this description, remove it and try again. The filter assembly will easily rotate in the bobbins when properly seated.

Figure 5A-7 Loading the Filter Assembly

5A.10

ThinPrep 2000 Processor Operator’s Manual

OPERATING INSTRUCTIONS

SECTION

Clamps

Slide

LOADING THE THINPREP MICROSCOPE SLIDE

1. Label the ThinPrep slide with patient’s identification information. Use the frosted area of the slide. When using an adhesive label, ensure that the label is completely adhered to the slide and that there are no overhanging edges.

2. Using two hands, hold the slide by the two front corners with your index fingers and thumbs as shown in Figure 5A-8. Be sure not to touch the slide within the defined screening area. Place the label end to the right and facing down.

3. Insert the slide. Using the slide to push the spring-loaded clamps down, insert the slide halfway under the upper guide block and over the spring-loaded clamps, then release the slide. Refer to Figure 5A-8.

Figure 5A-8 Inserting the Slide onto the Clamps

LABE

ThinPrep 2000 Processor Operator’s Manual

5A.11

5A5A

OPERATING INSTRUCTIONS

LABEL END

Slide properly placed

Slide skewed to left Slide skewed to right

4. The slide should now rest on top of the two clamps and under the upper guide block as shown in Figure 5A-9.

Figure 5A-9 Correct/Incorrect Slide Insertion

5A.12

ThinPrep 2000 Processor Operator’s Manual

OPERATING INSTRUCTIONS

Slide

5. To fully insert the slide, place your index fingers against the exposed edge of the slide and push the slide in until it does not go any further, as shown in Figure 5A-10. The slide handler clamps grasp the slide when the slide is seated correctly and the slide moves up slightly behind the upper guide block.

Figure 5A-10 Inserting the Slide Fully

LABEL

Note:

To remove a slide, press down on the front edge of the slide. Gently pull the slide toward you.

ThinPrep 2000 Processor Operator’s Manual

5A.13

5A5A

OPERATING INSTRUCTIONS

SECTION

FROSTED END

MAX

LOADING THE FIXATIVE VIAL

1. Fill a fixative vial with standard laboratory fixative alcohol until the fluid level is between the “MIN” and “MAX” marks on the vial.

If the staining protocol requires alternative fixation methods, leave the fixative vial empty or fill it with the appropriate fixative solution.

Change the contents of the fixative vial at least every 100 slides or daily, whichever occurs first.

2. Place the fixative vial into the fixative bath holder until the bottom of the vial rests on the base of the holder. Refer to Figure 5A-11. Ensure that the fixative vial is completely seated.

Figure 5A-11 Loading the Fixative Vial

5A.14

ThinPrep 2000 Processor Operator’s Manual

Hologic thinprep 2000 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

Introduction

OVERVIEW AND FUNCTION OF THE THINPREP® 2000 SYSTEM

PRINCIPLES OF OPERATION

THINPREP 2000 SYSTEM TECHNICAL SPECIFICATIONS

INTERNAL QUALITY CONTROL

THINPREP 2000 HAZARDS

DISPOSAL

ThinPrep 2000 Installation

GENERAL

ACTION UPON DELIVERY

PREPARATION PRIOR TO INSTALLATION

INTERNAL PACKAGING REMOVAL

CONNECTING THE WASTE BOTTLE

INSERTING THE PROGRAM MEMORY CARD

CONNECTING THE POWER CORD

TURNING ON YOUR THINPREP 2000 PROCESSOR

RUN A BLANK SAMPLE

STORAGE AND HANDLING - POST INSTALLATION

TURNING OFF THE THINPREP 2000 PROCESSOR

PreservCyt Solution

INTRODUCTION

PRESERVCYT® SOLUTION

Packaging

Composition

Storage Requirements

Transportation

Stability

Handling/Disposal

Interfering Substances

Gynecologic Sample Preparation

INTRODUCTION

COLLECTION PREPARATION

ThinPrep Collection Techniques

Patient Information

Specimen Collection Preparation

SPECIMEN COLLECTION

Collect Gynecologic Sample Using the Broom-Like Device

Collect Gynecologic Sample, Using the Endocervical Brush/Spatula Device

SPECIAL PRECAUTIONS

PreservCyt Solution

Interfering Substances

Handling/Disposal

SPECIMEN PROCESSING

Materials Required

Specimen Preparation

Run On ThinPrep 2000 Processor Using Sequence 4, Fix, Stain, and Evaluate

Stability

Sample Processing Troubleshooting

Operating Instructions

INTRODUCTION

OPTIONAL INSTRUCTIONS FOR ANCILLARY TESTING

Removing an Aliquot (of up to 4 mL) from the PreservCyt Sample Vial prior to performing the ThinPrep Pap Test

MATERIAL REQUIREMENTS

PRE-OPERATION CHECKLIST

OVERVIEW OF LOADING THE THINPREP® 2000 PROCESSOR

LOADING THE PRESERVCYT SAMPLE VIAL

LOADING THE THINPREP PAP TEST FILTER

Method A:

Method B:

LOADING THE THINPREP MICROSCOPE SLIDE

LOADING THE FIXATIVE VIAL