Hologic ThinPrep Operator's Manual

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ThinPrep

Operator’s Manual

Integrated Imager

ThinPrep® Integrated Imager Operator’s Manual

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Tel: 1-800-442-9892

1-508-263-2900 Fax: 1-508-229-2795 Web: www.hologic.com

For Use With Version 1.x.y Software

MAN-05283-001

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

Integrated Imager.

The ThinPrep® Integrated Imager is a PC-based automated imaging and review system for use with ThinPrep cervical cytology sample slides. The ThinPrep Integrated Imager is intended to help a cytotechnologist or pathologist highlight areas of a slide for further manual review. The Product is not a replacement for manual review. Determination of slide adequacy and patient diagnosis is at the sole discretion of the cytotechnologists and pathologists trained by Hologic to evaluate ThinPrepprepared slides. If and only if it is finally determined by a court of competent jurisdiction that the Product sold to Customer hereunder was defective in design or contained a manufacturing defect and that such defect was solely responsible for an error in diagnosis that caused harm to a patient, Hologic shall indemnify Customer for the compensatory damages paid by Customer to discharge the personal injury judgment with respect to Product.

© Hologic, Inc., 2018. 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, PreservCyt, and ThinPrep are registered trademarks of Hologic, Inc. in the United States and other countries. All other trademarks are the property of their respective companies.

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-16644-001 Rev. 002

Instructions For Use

Operation Summary and Clinical Information



The ThinPrep® Integrated Imager



A. INTENDED USE

The Hologic ThinPrep® Integrated Imager is a device that uses computer imaging technology to assist in primary cervical cancer screening of ThinPrep

Pap Test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma as well as all other cytologic criteria as defined by the Bethesda System: Terminology for Reporting Results of Cervical Cytology

B. SUMMARY AND EXPLANATION OF THE SYSTEM

The ThinPrep Integrated Imager is an automated imaging and review system for use with ThinPrep Pap Test slides. It combines imaging technology to identify microscopic fields of diagnostic interest with automated stage movement of a microscope in order to locate these fields. In routine use, the ThinPrep Integrated Imager selects 22 fields of view for a cytotechnologist (CT) to review. Following review of these fields, the cytotechnologist will either complete the diagnosis if no abnormalities are identified or review the entire slide if any abnormalities are identified. The ThinPrep Integrated Imager also allows the physical marking of locations of interest for the cytopathologist.

C. PRINCIPLES OF OPERATION

The ThinPrep Integrated Imager is a combined system which uses computerized image analysis and automated microscope location to assist a cytotechnologist or pathologist to identify areas of a slide that are of most interest. Slides used with this system must first be prepared on the ThinPrep or ThinPrep be used as a conventional microscope when not used for ThinPrep

5000 processors, and stained with ThinPrep® Stain. The ThinPrep Integrated Imager can

imaging.

2000 System

The ThinPrep Integrated Imager images the entire cell spot of the slide in approximately 90 seconds. The system acquires and processes image data from the slides to identify diagnostically relevant cells or cell groups based on an imaging algorithm that considers cellular features and nuclear darkness. During

slide imaging, the alphanumeric slide accession identifier is recorded and the x and y coordinates of

22 fields of interest are stored in the system.

After image processing, the device acts as an automated microscope, presenting the 22 fields containing the cells of interest to the cytotechnologist for review. The cytotechnologist uses the review control or touch screen to step through each of the fields of interest (Autolocate). Additionally, the review scope provides a method for automated marking of objects for further review. If the cytotechnologist identifies any of these fields as containing abnormal objects, that field may be marked electronically. The Integrated Imager will guide the cytotechnologist to conduct a review of the entire cell spot for any slide that has had fields electronically marked (Autoscan).

The cytotechnologist determines specimen adequacy and the presence of infections during the review of the 22 fields of view presented by the ThinPrep Integrated Imager. Either of two methods can be used to determine specimen adequacy. The first method is to count cells and determine the average number of cells in the 22 fields of view presented by the Imager. The second method is to count and determine the average number of cells in 10 fields of view across the diameter of the cell spot. Either method will enable the cytotechnologist to determine if the minimum cells, as recommended by Bethesda System criteria, are present on the slide. At the conclusion of the slide review, electronically marked objects are manually marked on the slide by the cytotechnologist. Slide information is stored in the computer

database including the x and y coordinates representing the electronically marked locations, and the

status of the slide is designated as “complete”.

MAN-05359-001 -001 Rev. 001 page 2 of 32

The cytotechnologist can review the slides immediately after each slide is imaged (sequential modality) or, as an alternative workflow for labs, slides can be imaged in succession, and coordinates stored in the computer database for later cytotechnologist or pathologist review (batched modality).

D. LIMITATIONS

 Only personnel who have been appropriately trained should operate the ThinPrep Integrated Imager.  All slides that undergo primary automated screening with the Integrated Imager require manual

rescreening of the selected fields of view by a cytotechnologist or pathologist.

 The ThinPrep Integrated Imager is only indicated for use with the ThinPrep Pap Test.  The ThinPrep Integrated Imager is only indicated for the ThinPrep Pap Test slides prepared with the

ThinPrep indicated for the ThinPrep Pap Test slides prepared with the ThinPrep

 ThinPrep

2000 System and the ThinPrep® 5000 processor. The ThinPrep Integrated Imager is not

slides with fiducial marks must be used.

3000 processor.

 Slides must be stained using the ThinPrep Stain according to the applicable ThinPrep Integrated

Imager slide staining protocol.

 Slides should be clean and free of debris before being placed on the system.  The slide coverslip should be dry and located correctly.  Slides that are broken or poorly coverslipped should not be used.  Slides used with the ThinPrep Integrated Imager must contain properly formatted accession number

identification information as described in the operator’s manual.

 Slides once successfully imaged on the Integrated Imager cannot be imaged again.  The performance of the ThinPrep Integrated Imager using slides prepared from reprocessed sample

vials has not been evaluated; therefore it is recommended that these slides be manually reviewed.

E. WARNINGS

 The Integrated Imager generates, uses, and can radiate radio frequency energy and may cause

interference to radio communications.

 A Hologic authorized service representative must install the ThinPrep Integrated Imager.

F. PRECAUTIONS

 Caution should be used when loading and unloading glass slides on the ThinPrep Integrated Imager

to prevent slide breakage and/or injury.

 The Integrated Imager should be placed on a flat, sturdy surface away from any vibrating

machinery to assure proper operation.

G. PERFORMANCE CHARACTERISTICS

The ThinPrep Integrated Imager is technologically similar to the ThinPrep Imaging System. The performance characteristics of the ThinPrep Integrated Imager were compared to the ThinPrep Imaging System in a multi-center clinical study. The ThinPrep

Imaging System was compared to Manual

MAN-05359-001 -001 Rev. 001 page 3 of 32

Review in a separate multi-center clinical study. Both clinical studies are described in the following sections.

G.1 ThinPrep Imaging System Compared to Manual Review

A multi-center, two-armed clinical study was performed over an eleven (11) month period at four (4) cytology laboratory sites within the United States Center Trial Evaluating the Primary Screening Capability of the ThinPrep

. The objective of the study entitled “Multi-

Imaging System” was to show that routine screening of ThinPrep Pap Test slides using the ThinPrep Imaging System is equivalent to a manual review of ThinPrep slides for all categories used for cytologic diagnosis (specimen adequacy and descriptive diagnosis) as defined by the Bethesda System criteria

The two-arm study approach allowed for a comparison of the cytologic interpretation (descriptive diagnosis and specimen adequacy) from a single ThinPrep-prepared slide, screened first using

standard laboratory cervical cytology practices (Manual Review) and then after a 48-day time lag were screened with the assistance of the ThinPrep Imaging System (Imager Review). A subset of

slides from the study were reviewed and adjudicated by a panel of three (3) independent cytopathologists to determine a consensus diagnosis. The consensus diagnosis was used as a “gold standard” for truth to evaluate the results of the study.

G.1.1 Laboratory and Patient Characteristics

Of the 10,359 subjects in the study, 9,550 met the requirements for inclusion in the descriptive diagnosis analysis. During the study, 7.1% (732/10,359) slides could not be read on the Imager

and required a manual review during the Imager Review arm. Excessive number of air bubbles

on the slides was the leading contributor. Additional factors included focus problems, slide density, slide identification read failures, slides detected out of position, multiple slides seated within a cassette slot and slides that had already been imaged. The cytology laboratories participating in the study were comprised of four centers. All sites selected had extensive experience in the processing and evaluation of gynecologic ThinPrep slides, and were trained in the use of the ThinPrep Imaging System. The study population represented diverse geographic regions and subject populations of women who would undergo cervical screening with the ThinPrep Imaging System in normal clinical use. These sites included both women being routinely screened (screening population) and patients with a recent previous cervical abnormality (referral population). The characteristics of the study sites are summarized in Table 1.

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MAN-05359-001 -001 Rev. 001 page 4 of 32

Table 1. Site Characteristics

Site 1 2 3 4

Screening (Low Risk)

Population

Referral (High Risk)

Population

HSIL+ prevalence

ThinPrep Pap Tests Per Year

Number of Cytotechnologists Number of Cytotechnologists

in Study Number of Cytopathologists Number of Cytopathologists

in Study

88% 82% 90% 94%

12% 18% 10% 6%

1.1% 0.7% 0.4% 0.6%

120,000 70,200 280,000 105,000

14 9 32 11

2 2 2 2

6 5 6 14

1 2 1 2

G.1.2 Descriptive Diagnosis Sensitivity and Specificity Estimates

A panel of three independent cytopathologists adjudicated slides from all discordant (one-grade or higher cytologic difference) descriptive diagnosis cases (639), all concordant positive cases (355) and a random 5% subset of the 8550 negative concordant cases (428). The cytopathologists on the adjudication panel were board-certified, all of whom had a subspecialty certification in cytopathology. Their experience levels in cytopathology ranged from 6 to 12 years. Two of the adjudicators were from university practices and one adjudicator was from a private medical center. The volumes for the adjudicators’ institutions ranged from 12,000 to 30,000 ThinPrep Pap Tests annually.

A consensus diagnosis was defined as agreement by at least 2 of 3 cytopathologists. All slides sent to the panel of cytopathologists were not identified by site nor ordered in any fashion. When a consensus diagnosis could not be obtained by at least 2 of 3 cytopathologists, the full panel of cytopathologists reviewed each case simultaneously using a multi-headed microscope to determine a consensus diagnosis.

The adjudicated results were used as a “gold standard” to define the following major “true” descriptive diagnosis classifications of the Bethesda System: Negative, ASCUS, AGUS, LSIL, HSIL, Squamous Cell Carcinoma (SQ CA) and Glandular Cell Carcinoma (GL CA). Estimates of sensitivity and specificity together with 95% confidence intervals were calculated for the

Manual Review and Imager Review arms of the study. The differences in sensitivity and

specificity between the two arms, together with their 95% confidence intervals were also calculated. Among the random 5% subset of 8,550 cases (428 slides) that were found to be negative by both arms and adjudicated, there were 425 “true” negative and 3 “true” ASCUS slides. A multiple imputation technique was used to adjust the numbers of true positives and true negatives for the 8,550 negative concordant cases based on the 5% of cases that were adjudicated

Table 2 summarizes the descriptive diagnosis sensitivity and specificity estimates with 95% confidence intervals for all sites combined for “true” ASCUS+, LSIL+ and HSIL+.

MAN-05359-001 -001 Rev. 001 page 5 of 32

Table 2. Manual Review Versus Imager Review, Descriptive Diagnosis Summary

Sensitivity Specificity

Threshold

ASCUS+

LSIL+ HSIL+

UNSAT

Manual

(95% CI)

75.6%

(72.2% to 78.8%)

79.7%

(75.3% to 83.7%)

74.1%

(66.0% to 81.2%)

29.3%

(18.1% to 42.7%)

Imager

(95% CI)

82.0%

(78.8% to 84.8%)

79.2%

(74.7% to 83.2%)

79.9%

(72.2% to 86.2%)

13.8%

(6.1% to 25.4%)

Difference

(95% CI)

+6.4%

(2.6% to 10.0%)

-0.5%

(-5.0 % to 4.0%)

+5.8%

(-1.1% to 12.6%)

-15.5%

(-25.9% to 5.0%)

Manual

(95% CI)

97.6%

(97.2% to 97.9%)

99.0%

(98.8% to 99.2%)

99.4 %

(99.2% to 99.6%)

99.5%

(99.3% to 99.6%)

Imager

(95% CI)

97.8%

(97.4% to 98.1%)

99.1%

(98.9% to 99.3%)

99.6%

(99.5% to 99.7%)

99.8%

(99.7% to 99.9%)

Difference

(95% CI)

+0.2%

(-0.2% to 0.6%)

+0.09%

(-0.1% to 0.3%)

+0.2%

(0.06% to 0.4%)

+0.3%

(0.2% to 0.4%)

The results presented in Table 2 show that for ASCUS+, the increase in sensitivity of the Imager Review over the Manual Review was statistically significant with the lower limit of the 95%

confidence interval being 2.6% for all sites combined. The observed difference between sensitivities for ASCUS+ varied among the sites from –2.8% with a 95% confidence interval of (–10.6%; 5.0%) to +14.4% with a 95% confidence interval of (8.2%; 20.5%). The difference in

specificity results between the Imager Review and the Manual Review was not statistically

significant with a 95% confidence interval of –0.2% to +0.6%. The observed differences between specificities varied among the sites from –0.3% to +0.4%.

The results presented in Table 2 show that the difference between sensitivities of the Imager Review and Manual Review arms for LSIL+ for all sites combined was not statistically

significant with a 95% confidence interval of –5.0% to +4.0%. The observed difference between sensitivities for LSIL+ varied among the sites from –6.3% with a 95% confidence interval of (–14.7%; 2.1%) to +8.1% with a 95% confidence interval of (–4.0%; 20.1%). The difference in

specificity results between the Imager Review and the Manual Review was not statistically

significant with a 95% confidence interval of –0.1% to +0.3%. The observed differences between specificities varied among the sites from –0.4% to +0.6%.

The results presented in Table 2 show that the difference between sensitivities of the Imager Review and Manual Review arms for HSIL+ for all sites combined was not statistically

significant with a 95% confidence interval of –1.1% to +12.6%. The observed difference between sensitivities for HSIL+ varied among the sites from –2.5% with a 95% confidence interval of (–15.4%; 10.4%) to +13.6% with a 95% confidence interval of (–0.7%; 28.0%). The

increase in specificity of the Imager Review over the Manual Review was statistically significant

with a 95% confidence interval of +0.06% to +0.4%. The observed differences between specificities varied among the sites from –0.1% to +0.7%.

Table 3 shows the unadjudicated marginal frequencies data for benign cellular changes for all sites combined.

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MAN-05359-001 -001 Rev. 001 page 6 of 32

Table 3. Unadjudicated Marginal Frequencies – Summary of Descriptive Diagnosis

for Benign Cellular Changes – All Sites Combined



Manual Review Imager Review

Number of Patients: 9550 9550

Descriptive Diagnosis N % N %

Benign Cellular Changes: 405 4.2 293 3.1

Infection:

Trichomonas Vaginalis 8 0.1 8 0.1 Fungal organisms consistent with Candida spp. 47 0.5 31 0.3

Predominance of coccobacilli 71 0.7 60 0.6 Bacteria consistent with Actinomyces spp. 1 0.0 1 0.0 Cellular Changes associated with Herpes virus 1 0.0 1 0.0 Other Infection 1 0.0 0 0.0

Reactive Cellular Changes Associated with:

Inflammation 218 2.3 156 1.6 Atrophic with inflammation (atrophic vaginitis) 68 0.7 46 0.5 Radiation 0 0.0 0 0.0 Intrauterine contraceptive device (IUD) 0 0.0 0 0.0 Other Reactive Cellular Change 34 0.4 14 0.1



Note: Some patients had more than one diagnostic subcategory.

The Manual Review showed a higher rate of Benign Cellular Changes (405) than the Imager Review cases (293).

Please refer to the ThinPrep

Imaging System Operation Summary and Clinical Information (MAN-03938-001) for detailed information about the performance of ThinPrep Imaging System.

G.2 ThinPrep Integrated Imager Compared to the ThinPrep Imaging System

A multi-center, two-armed clinical study was performed at three (3) sites within the United States. The objective of the study entitled “Multi-Center Evaluation of the ThinPrep was to show that routine screening of ThinPrep Pap Test slides prepared on the ThinPrep System and the ThinPrep

5000 processor using the ThinPrep Integrated Imager is similar to the review of ThinPrep slides using the ThinPrep Imaging System for all categories used for cytologic diagnosis (specimen adequacy and descriptive diagnosis) as defined by the Bethesda System criteria

The two-arm study approach allowed for a comparison of the cytologic interpretation (descriptive diagnosis and specimen adequacy) from a single ThinPrep-prepared slide (of known diagnosis), screened first using the Integrated Imager and then after two-week lag were screened with the assistance of the ThinPrep Imaging System. The adjudicated diagnosis at enrollment was used as a “gold standard” for truth to evaluate the results of the study.

Slides utilized in this study were processed on the ThinPrep

2000 System and the ThinPrep® 5000 processor. Study slides were produced, reviewed manually and adjudicated during the execution of a previous study

All slides were reviewed independently for both study arms. The slides were randomized prior to slide review in each study arm. Cytological diagnoses and specimen adequacy were determined in accordance with the Bethesda System criteria for both arms of the study.

Integrated Imager”

2000

MAN-05359-001 -001 Rev. 001 page 7 of 32

G.2.1 Laboratory and Patient Characteristics

The cytology laboratories participating in the study were comprised of three (3) centers. All sites selected had extensive experience in the processing and evaluation of gynecologic ThinPrep slides, and were trained in the use of the ThinPrep Integrated Imager.

Number of patients (planned and analyzed)

2520 slides (840 each site) were enrolled in this study. Six (6) out of 2520 (0.2%) slides were excluded from review and analysis as they were broken and unreadable.

Basic demographic information was collected for each slide enrolled at each site to aid the cytotechnologist in making a diagnosis for the resulting slides. A summary of this demographic information is presented in Table 4 for all sites.

Table 4. Site Demographics

Site

Number

Age (yrs)

Median

# Hysterectomy

(% of enrolled)

# Postmenopausal

(% of enrolled)

1 36 yrs 11 (2.6%) 30 (7.1%) 2 33 yrs 15 (3.6%) 25 (6.0%) 3 37 yrs 25 (6.0%) 51 (12.1%)

Overall 35 yrs 51 (4.0%) 106 (8.4%)

Each slide was reviewed independently three (3) times at each site, by three (3) separate pairs of cytotechnologists and pathologists using normal laboratory and clinical procedures. This produced a total of 7542 diagnostic results. None of these results were excluded from analysis.

Main Eligibility Criteria

Inclusion Criteria

Study slides (two slides per case, one slide was prepared on the ThinPrep 2000 System and another slide was prepared on the ThinPrep 5000 processor) were produced, reviewed manually and adjudicated during the execution of a previous study three sites included the following:

o NILM: 1260 slides from 630 cases o ASC-US: 300 slides from 150 cases o LSIL: 300 slides from 150 cases

. The ThinPrep Pap Test slides from

o ASC-H: 300 slides from 150 cases o AGUS: 30 slides from 15 cases o HSIL: 300 slides from 150 cases o Cancers: 30 slides from 15 cases

Exclusion Criteria

Slide broken or rendered unreadable for the purposes of this study.

Criteria for Evaluation

The primary objective of this study was to estimate the sensitivity, specificity, and likelihood ratios when diagnosing slides imaged and reviewed on the Integrated Imager (sequential

MAN-05359-001 -001 Rev. 001 page 8 of 32

modality) and to compare with the ThinPrep Imaging System (TIS). The reference standard for the slides in this study was pathologist adjudication consensus diagnosis from a previous study

G.2.2 Descriptive Diagnosis Sensitivity and Specificity Estimates

Abbreviations for Diagnostic Thresholds:

Category Partitions

Threshold Negative Positive

ASCUS+ NILM

LSIL+ NILM, ASCUS LSIL, ASC–H, AGUS, HSIL, Cancer

ASC–H+ NILM, ASCUS, LSIL ASC–H, AGUS, HSIL, Cancer

HSIL+

NILM, ASCUS, LSIL, ASC–H,

AGUS

The study results are presented in Table 5. In all abnormal categories, the sensitivity for the Integrated Imager was higher than the ThinPrep Imaging System across all thresholds listed in Table 5. There was a slight decrease in specificity for the Integrated Imager as compared to the ThinPrep Imaging System.

Table 5. ThinPrep Imaging System (TIS) Versus Integrated Imager,

Descriptive Diagnosis Summary (All Slides)

ASCUS, LSIL, ASC–H, AGUS, HSIL,

Cancer

HSIL, Cancer



Threshold

ASCUS+

LSIL+

ASC-H+

HSIL+

UNSAT

TIS

(95% CI)

86.0%

(84.7% to 87.3%)

77.8%

(76.0% to 79.6%)

73.3%

(70.4% to 75.9%)

59.6%

(55.9% to 63.3%)

78.9%

(71.6% to 84.7%)

In addition, the data is presented below stratified by the type of processor used (ThinPrep 2000 System and ThinPrep 5000 processor). In all abnormal cases, the sensitivity for the Integrated Imager was higher than the ThinPrep Imaging System across all thresholds. There was a slight decrease in specificity for the Integrated Imager as compared to the ThinPrep Imaging System.



Sensitivity Specificity

Integrated

Imager

(95% CI)

89.8%

(88.6% to 90.9%)

83.7%

(82.0% to 85.2%)

80.7%

(78.1% to 83.0%)

67.5%

(63.9% to 70.9%)

77.6%

(70.2% to 83.5%)

Difference

(95% CI)

3.8%

(2.6% to 5.0%)

5.8%

(4.1% to 7.5%)

7.4%

(4.7% to 10.1%)

7.9%

(4.5% to 11.2%)

-1.4%

(-7.3% to 4.5%)

TIS

(95% CI)

89.8%

(88.9% to 90.6%)

92.5%

(91.7% to 93.2%)

92.7%

(92.0% to 93.3%)

95.1%

(94.6% to 95.6%)

98.4%

(98.1% to 98.6%)

Integrated

Imager

(95% CI)

87.9%

(86.9% to 88.8%)

90.6%

(89.8% to 91.4%)

91.1%

(90.4% to 91.8%)

94.0%

(93.4% to 94.6%)

98.4%

(98.1% to 98.7%)

Difference

(95% CI)

-1.9%

(-2.8% to -1.0%)

-1.9%

(-2.6% to -1.2%)

-1.6%

(-2.1% to -1.0%)

-1.1%

(-1.6% to -0.6%)

0.1%

(-0.2% to 0.3%)

MAN-05359-001 -001 Rev. 001 page 9 of 32

Table 6. ThinPrep Imaging System (TIS) Versus Integrated Imager (I2),

Descriptive Diagnosis Summary (ThinPrep 2000 System-processed Slides Only)

Sensitivity Specificity

Threshold

ASCUS+

LSIL+

ASC-H+

HSIL+

UNSAT

TIS

[# of reads]

(95% CI)

85.7%

[1209/1411]

(83.8% to 87.4%)

77.6%

[820/1057]

(75.0% to 80.0%)

73.1%

[370/506]

(69.1% to 76.8%)

59.0%

[214/363]

(53.8% to 63.9%)

83.3%

[65/78]

(73.5% to 90.0%)

[# of reads]

(95% CI)

90.0%

[1270/1411]

(88.3% to 1.5%)

84.3%

[891/1057]

(82.0% to 86.4%)

81.8%

[414/506]

(78.2% to 84.9%)

70.2%

[255/363]

(65.4% to 74.7%)

82.1%

[64/78]

(72.1% to 89.0%)

Difference

[# of reads]

(95% CI)

4.3%

[61/1411]

(2.6% to 6.1%)

6.7%

[71/1057]

(4.3% to 9.1%)

8.7%

[44/506]

(4.9% to 12.5%)

11.3%

[41/363]

(6.4% to 16.1%)

-1.3%

[1/78]

(-8.9% to 6.2%)

TIS

[# of reads]

(95% CI)

90.3%

[2006/2222]

(89.0% to 91.4%)

92.7%

[2388/2576]

(91.6% to 93.6%)

92.8%

[2903/3127]

(91.9% to 93.7%)

95.4%

[3118/3270]

(94.6% to 96.0%)

98.6%

[3647/3699]

(98.2% to 98.9%)

[# of reads]

(95% CI)

88.9%

[1975/2222]

(87.5% to 90.1%)

91.3%

[2353/2576]

(90.2% to 92.4%)

91.1%

[2849/3127]

(90.1% to 92.1%)

94.2%

[3081/3270]

(93.4% to 95.0%)

98.6%

[3649/3699]

(98.2% to 99.0%)

Difference

[# of reads]

(95% CI)

-1.4%

[-31/2222]

(-2.7% to -0.1%)

-1.4%

[-35/2576]

(-2.3% to -0.4%)

-1.7%

[-54/3127]

(-2.5% to -1.0%)

-1.1%

[-37/3270]

(-1.8% to -0.5%)

0.1%

[2/3699]

(-0.3% to 0.4%)

Table 7. ThinPrep Imaging System (TIS) Versus Integrated Imager (I2),

Descriptive Diagnosis Summary (ThinPrep 5000 Processor-processed Slides Only)

Sensitivity Specificity

Threshold

ASCUS+

LSIL+

ASC-H+

HSIL+

UNSAT

TIS

[# of reads]

(95% CI)

86.4%

[1190/1377]

(84.5% to 88.1%)

78.1%

[796/1019]

(75.5% to 80.5%)

73.4%

[354/482]

(69.3% to 77.2%)

60.4%

[194/321]

(55.0% to 65.6%)

73.9%

[51/69]

(62.5% to 82.8%)

[# of reads]

(95% CI)

89.6%

[1234/1377]

(87.9% to 91.1%)

83.0%

[846/1019]

(80.6% to 85.2%)

79.5%

[383/482]

(75.6% to 82.8%)

64.5%

[207/321]

(59.1% to 69.5%)

72.5%

[50/69]

(61.0% to 81.6%)

Difference

[# of reads]

(95% CI)

3.2%

[44/1377]

(1.6% to 4.8%)

4.9%

[50/1019]

(2.5% to 7.3%)

6.0%

[29/482]

(2.2% to 9.8%)

4.0%

[13/321]

(-0.6% to 8.6%)

-1.4%

[1/69]

(-11.3% to 8.4%)

TIS

[# of reads]

(95% CI)

89.3%

[1989/2228]

(87.9% to 90.5%)

92.2%

[2385/2586]

(91.1% to 93.2%)

92.5%

[2888/3123]

(91.5% to 93.3%)

94.9%

[3116/3284]

(94.1% to 95.6%)

98.2%

[3628/3696]

(97.7% to 98.5%)

[# of reads]

(95% CI)

86.8%

[1935/2228]

(85.4% to 88.2%)

89.9%

[2324/2586]

(88.6% to 91.0%)

91.1%

[2845/3123]

(90.0% to 92.0%)

93.8%

[3082/3284]

(93.0% to 94.6%)

98.2%

[3630/3696]

(97.7% to 98.6%)

Difference

[# of reads]

(95% CI)

-2.4%

[-54/2228]

(-3.8% to -1.1%)

-2.4%

[-61/2586]

(-3.4% to -1.4%)

-1.4%

[-43/3123]

(-2.2% to -0.6%)

-1.0%

[-34/3284]

(-1.7% to -0.3%)

0.1%

[2/3696]

(-0.3% to 0.4%)

Tables 8 through 14 show the performance of TIS review and Integrated Imager review compared to adjudicated diagnosis made by the adjudication panel (truth, from previous study) for the following major descriptive diagnosis classifications of the Bethesda System: NILM, ASCUS, LSIL, ASC-H, AGUS, HSIL and Cancer.



MAN-05359-001 -001 Rev. 001 page 10 of 32

Table 8. “True Negative” (NILM) Contingency Table (for All Sites Combined)

Overall Adjudicated NILM

TIS vs. I2

TIS UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer

75 29 2 0 1 1 0 0 25 3735 147 5 13 7 3 0

5 187 123 11 16 1 1 0 0 21 22 14 2 0 2 0 1 29 20 1 23 1 4 0 1 15 3 0 0 5 0 0 0 8 4 0 10 0 10 0 0 0 2 0 0 1 0 4

UNSAT

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

Cancer

Table 9. “True ASCUS” Contingency Table (for All Sites Combined)

Overall Adjudicated ASCUS

TIS vs. I2

TIS UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer

2 0 1 0 2 0 0 0 1 143 36 7 4 5 2 1 0 76 113 23 15 0 3 0 1 11 33 45 5 0 2 0 0 16 18 5 37 1 19 0 1 0 0 0 1 2 0 0 0 5 6 5 19 0 53 0 0 0 0 1 0 0 0 0

UNSAT

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

Cancer

Table 10. “True LSIL” Contingency Table (for All Sites Combined)

Overall Adjudicated LSIL

TIS vs. I2

TIS UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer

1 0 0 0 0 0 0 0 0 13 11 8 0 0 1 0 0 18 107 49 4 0 1 0 0 19 86 516 10 0 17 0 0 3 12 13 16 1 16 9 0 0 0 0 0 0 0 0 0 1 3 40 11 2 107 0 0 0 0 2 0 0 0 1

UNSAT

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

Cancer



MAN-05359-001 -001 Rev. 001 page 11 of 32

Table 11. “True ASC-H” Contingency Table (for All Sites Combined)

Overall Adjudicated ASC-H

TIS vs. I2

TIS UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer

0 0 0 0 1 0 0 0 0 5 4 0 2 1 1 0 0 9 16 1 13 0 4 0 0 1 3 2 7 0 1 0 0 4 14 1 31 1 9 0 0 1 1 0 0 0 0 0 0 4 4 2 17 0 31 1 0 0 1 0 0 0 0 2

UNSAT

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

Cancer

Table 12. “True AGUS” Contingency Table (for All Sites Combined)

Overall Adjudicated AGUS

TIS vs. I2

TIS UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer

1 0 0 0 0 0 0 0 1 30 2 0 1 3 0 0 0 2 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 4 1 2 0 2 10 3 0 1 12 1 1 1 2 2 0 4 3 9 0 2 2 1 0 0 1 1 9

UNSAT

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

Cancer

Table 13. “True HSIL” Contingency Table (for All Sites Combined)

Overall Adjudicated HSIL

TIS vs. I2

TIS UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer

0 0 0 0 0 0 0 0 0 4 0 0 0 0 0 0 0 3 12 1 7 0 2 1 0 2 7 28 7 0 5 0 0 0 16 13 58 1 23 2 0 1 3 0 1 1 3 0 0 3 12 26 44 6 243 5 0 0 0 1 0 1 16 12

UNSAT

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

Cancer



MAN-05359-001 -001 Rev. 001 page 12 of 32

Table 14. “True Cancer” Contingency Table (for All Sites Combined)

Overall Adjudicated Cancer

TIS vs. I2

TIS UNSAT NILM ASCUS LSIL ASC-H AGUS HSIL Cancer

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 1 1 2 0 0 0 0 0 0 1 0 6 0 8 0 0 0 0 1 0 19 1 0 0 0 0 0 4 5 63

UNSAT

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

Cancer

Table 15 shows the descriptive diagnosis marginal frequencies for benign cellular changes for all sites combined. Each slide was read three times, first by a cytotechnologist and then by a pathologist.

Table 15. Unadjudicated Marginal Frequencies –

Summary of Descriptive Diagnosis for Benign Cellular Changes –

All Sites Combined

Number of Reads

TIS Review I2 Review

7542 7542

Descriptive Diagnosis N % N %

Benign Cellular Changes 402 5.3% 420 5.6%

Organisms:

Trichomonas vaginalis Fungal organisms consistent with Candida spp. Shift in Flora s/o bacterial vaginosis Bacteria consistent with Actinomyces spp. Cellular changes consistent with Herpes virus Other infection

Other Non-Neoplastic Findings

Reactive cellular changes assoc. w/ inflammation Atrophy Reactive cellular changes assoc. w/ radiation Reactive cellular changes assoc. w/ IUD Glandular cells status post hysterectomy Endometrial cells in a woman ≥ 45 yrs of age

20 0.3% 28 0.4% 122 1.6% 128 1.7% 183 2.4% 208 2.8%

2 0.0% 3 0.0% 2 0.0% 1 0.0% 0 0.0% 0 0.0%

0.0% 34 0.5% 16 0.2% 33 0.4% 26 0.3%

0 0.0% 0 0.0% 0 0.0% 1 0.0% 0 0.0% 0 0.0% 6 0.1% 9 0.1%

The Integrated Imager showed a slightly higher rate of Benign Cellular Changes (420 out of 7542, or 5.6%) than TIS Review (402 out of 7542, or 5.3%), however this was not statistically significant.

Conclusion

The sensitivity and specificity of Integrated Imager for review of ThinPrep 2000 slides and ThinPrep 5000 slides are similar to the sensitivity and specificity of the ThinPrep Imaging System.



MAN-05359-001 -001 Rev. 001 page 13 of 32

G2.3 Analytical performance of Integrated Imager

Within-instrument Reproducibility

Analytical performance was evaluated by reviewing the content of the 22 fields of view (FOVs) presented by the Integrated Imager. Evaluations were carried out by cytotechnologists. No pathologist reviewed the FOV. Full slide reviews were not carried out for this evaluation.

Within-instrument reproducibility results were collected by three (3) cytotechnologists who performed review of slides three (3) times on the same instrument with a washout period of a minimum of 14 days.

The 260 slides used in this study were previously prepared from ThinPrep specimens and had an adjudicated cytology diagnosis.

The highest ranked diagnosis from review of 22 FOVs and number of abnormal FOVs were recorded for each of three runs for both TIS review and I2 review.

In Table 16, the within-instrument results are summarized for each diagnostic category of slides (according to adjudicated truth results). For each grouping, the following metrics are reported:

 % Abnormal

The proportion of slides for which any abnormal FOVs were observed. (For NILM or UNSAT slides, the % Normal column is used to record the proportion that are not abnormal).

 % Category+

The proportion of slides for which at least one FOV was observed with content of the slide’s true category or higher.

 % N/A

The proportion of slides in that category that are excluded from analysis (slide not able to be imaged by imager or missing data)

 Abnormal FOV, % zero

The proportion of slides for which zero abnormal FOV were observed.

 Abnormal FOV, Median

The median number of abnormal FOV observed (out of 22 total).

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MAN-05359-001 -001 Rev. 001 page 14 of 32

Table 16. Summarized Results of Within-instrument Study

Dx Imager

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

CANCER

UNSAT

TIS

Abnormal% Category+% Normal % N/A

69.6% 11.0% 70.4% 0

78.1% 4.3% 78.4% 0

Abnormal FOV

% zero Median

75.9% 75.9% 13.3% 25.0% 6

71.9% 71.9% 5.0% 28.1% 7

97.3% 93.2% 3.3% 2.8% 14

96.0% 94.0% 0.7% 4.0% 15

93.3% 86.7% 0.0% 6.7% 11.5 100% 83.3% 0.0% 0.0% 14

63.0% 51.9% 6.7% 35.7% 2

55.6% 48.1% 10.0% 44.4% 2

98.0% 77.3% 0.0% 2.0% 20

97.3% 71.3% 0.7% 2.7% 20 100% 46.7% 0.0% 0.0% 22 100% 53.3% 0.0% 0.0% 22

72.2% 40.0% 72.2% 0

85.7% 36.7% 94.7% 0

Between-instrument Reproducibility

Between-instrument reproducibility results were derived from the clinical study. In the clinical study, three (3) cytotechnologist/pathologist pairs reviewed slides on different instruments.

In Table 17, the between-instrument results are summarized for each diagnostic category of slides (according to adjudicated truth results). For each grouping, the following metrics are reported:

 % Abnormal

The proportion of slides for which any abnormal diagnosis was recorded. (For NILM or UNSAT slides, the % Normal column is used to record the proportion that are not abnormal).

 % Category+

The proportion of slides for which the site diagnosis was equal to or higher than the slide’s adjudicated category.

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MAN-05359-001 -001 Rev. 001 page 15 of 32

Table 17. Summarized Results of Between-instrument Study

Dx Imager

NILM

ASCUS

LSIL

ASC-H

AGUS

HSIL

CANCER

UNSAT

TIS

Abnormal% Category+% Normal

-- -- 90.0%

-- -- 88.1%

64.4% 64.4% --

71.7% 71.7% --

95.0% 75.0% --

96.9% 80.6% --

87.7% 62.6% --

92.8% 63.6% --

53.8% 37.6% --

67.5% 57.3% --

97.7% 54.7% --

99.3% 64.7% -100% 63.2% -100% 63.2% --

-- -- 95.2%

-- -- 93.2%

G2.4 Cytotechnologist Screening Rates During Clinical Study

During the study, nine (9) cytotechnologists (CTs) recorded the number of hours they worked each day and the number of slides screened for both the TIS and I2 reviews. The experience levels of the cytologists ranged from 4 to 30 years. During the study, the cytotechnologist’s screening times for both TIS Review and I2 Review included automated screening of the 22 fields of view, full slide review if the automated screening was not applicable, and automated screening of the 22 fields of view followed by full slide review when abnormal cells were identified during automated screening. The number of hours each cytotechnologist screened slides per day varied due to logistical issues and scheduling. Only the sequential modality of I2 Review was evaluated during clinical study.

These data are summarized in Table 18 below.

Note: These numbers represent total number of slides and does not consider the review type;

Field of view (FOV) only, Full Manual Review (FMR), or FOV+FMR. These rates are lower than would be routinely observed in clinical practice as the number of abnormal cases in this clinical study was much higher than typically observed in normal clinical practice (50% versus 10–20%).



MAN-05359-001 -001 Rev. 001 page 16 of 32

Table 18. CT Screening Rates

TIS

Site 1 CT 1 CT 2 CT 3 Site 2 CT 1 CT 2 CT 3 Site 3 CT 1 CT 2 CT 3

Average Slides/Hour



9.8 9.9

10.4 9.7

11.1 8.1

6.2 6.1

9.0 6.4

9.1 6.5

9.2 6.6

9.9 6.8

10.1 6.5

Average Slides/Hour

Combined Median 9.8 6.6



100% 67%

In this study, the number of equivalent slides reviewed could not be determined as the review type was not tracked.

CTs using the Integrated Imager scanned and reviewed 67% of the slides that CTs reviewed when using TIS.

Note: The time recorded for the TIS-reviewed slides does not account for the scanning time.

The scanning time adds approximately 90 seconds per slide when using the Integrated Imager Sequential Modality.

G2.5 Cytotechnologist Timing Study (Batched and Sequential Modalities)

An additional study “Cytotechnologist Screening Time Study ThinPrep® Integrated Imager” was performed to characterize the screening volumes for cytotechnologists (CTs) when assistive imaging is implemented as part of the slide review process. These data were collected using the Integrated Imager in two ways:

1. Each slide was imaged and then reviewed by a CT using the Integrated Imager. This is

referred to as Sequential Modality in this study (i.e., imaging and slide review is performed

consecutively, by the CT).

2. All slides were imaged as a batch using the Integrated Imager and then the CT reviewed

slides as a batch. This is referred to as Batched Modality in this study. In batched modality,

imaging of slides is performed in advance, separate from the slide review.

Three (3) CTs participated in this study. The CTs reviewed slides over three (3) days (screening slides for an 8-hour day) for each arm of the study. Slides were imaged and reviewed independently by each of the three CTs.

All slides were prepared from ThinPrep ThinPrep processor, and stained with ThinPrep Stain. Sets of 400 randomized slides per CT, each with approximately 10% abnormal diagnosis were provided in order to fully occupy a CT for three (3) full days of screening. The CTs were blinded to the diagnoses.

A minimum one-week “

washout period” occurred between study arms for each CT.

Table 19 shows the total breakdown of the types of reviews performed in the CT Timing Study.

specimens of known cytology diagnoses, on a

MAN-05359-001 -001 Rev. 001 page 17 of 32

Sequential Review Batched Review CT #1 CT #2 CT #3 Overall CT #1 CT #2 CT #3 Overall

Total # slides

reviewed

Table 19. Total Slides Reviewed by Review Type / CT

(% Autoscan = #FOV+FMR / Total # Slides Reviewed over 3 Days)

255 285 300 840 365 340 353 1058

# FOV only

# FOV+FMR

# FMR Only

% Autoscan

Referral

212 179 239 630 308 226 265 799

42 100 37 179 51 109 75 235

1 6 4 11 6 5 13 24

16% 35% 19% 24% 14% 32% 21% 22%



The results are shown in Table 20. The median number of slides screened per day when the

Integrated Imager in Sequential Modality was used for screening and reviewing of slides was

92 slides. CTs using the Integrated Imager in Batched Modality reviewed 86% of the maximum

number of slides that CTs could have reviewed when using TIS.

Table 20. Cytotechnologist Daily Slide Review Rates

# Slides Reviewed CT Day 1 Day 2 Day 3

87 80 88 87

90 100 95 95

92 108 100 100

Sequential

Modality

CT #1 CT #2 CT #3

Daily

Median

Overall Daily

Median

(67%*)

119 123 123 123

124 106 110 110

119 120 114 119

Batched

Modality

CT #1 CT #2 CT #3

* Percentage with regards to TIS being 100%.

The agreement of the CT diagnosis was compared to the adjudicated results and are shown in Table 21. High rates of agreement in diagnosis with the adjudicated slide results supports the clinical utility of this study.



119

(86%*)

MAN-05359-001 -001 Rev. 001 page 18 of 32

Table 21. PPA and NPA Results by Cytotechnologist Based on Adjudicated Results.

(Positive Results Mean ASC-US+)

CT #1 CT #2 CT #3

Overall

Sequential Modality Batched Modality

PPA NPA PPA NPA

100% 97% 97% 96% 100% 76% 100% 79%

91% 94% 100% 90% 97% 89% 99% 89%

Workload is defined by CLIA as a maximum limit of 100 slides in no less than an 8-hour workday. This refers to a full manual review of 100 slides.

When using automated Imaging systems, users may need to review only a portion of the slide in order to make a diagnosis of NILM, thereby decreasing the time needed for CT review. Conversely, in cases where abnormality is present, the partial slide review is followed by a full manual review, leading to a longer CT review time. In both cases, different values are used to account for the difference in review times in order to arrive at slide workload estimates. (See Tables 22 and 23.)

When using the Sequential Modality, the Integrated Imager scans the slide in approximately 90 seconds. This time should be considered when determining the value used for workload calculations.

When using the Batched Modality, the scanning time is not considered in the review time, and as such, more slides can be reviewed in an 8-hour day.

In order to help laboratories determine the workload, based on the number of slides reviewed with FOV only and FOV+FMR, for their cytotechnologists when using the Integrated Imager,

laboratories should use the following method in Table 22 and Table 24 for Sequential Modality and Table 23 and Table 25 for Batched Modality when calculating workload:

Tables 24 and 25 are intended to help individual cytotechnologists keep an on-going tally of the FOV only and FOV+FMR slides screened during each workday.

Table 22. Values for Calculating Workload,

Integrated Imager, Sequential Modality

FMR = 1 slide

FOV = 0.85 slide

FMR + FOV = 1.85 slides

Upper Limit = 100 slides



When using Sequential Modality, use the following equation for determining workload:

[(# slides FMR) (1) + (# slides FOV) (0.85) + (# slides FOV+FMR) (1.85)] = 100 slides



MAN-05359-001 -001 Rev. 001 page 19 of 32

Table 23. Values for Calculating Workload,

Integrated Imager, Batched Modality

FMR = 1 slide

FOV = 0.65 slide

FMR + FOV = 1.65 slides

Upper Limit = 100 slides

When using Batched Modality, use the following equation for determining workload:

[(# slides FMR) (1) + (# slides FOV) (0.65) + (# slides FOV+FMR) (1.65)] = 100 slides

Note: The ThinPrep

Integrated Imager workload limit in an 8-hour workday includes all activities needed to process the cases, not exclusively time spent using the microscope:

 Screening 22 Fields of View  Full manual slide review using the Autoscan feature  Review clinical history  Record results and triage appropriately

 Slides where only 22 Fields of View (FOV) are used for diagnosis should be considered as

less than a full slide.

o When using the Sequential Modality, a slide should be considered as 0.85 of a slide. o When the Batched Modality is used, a slide should be considered 0.65 of a slide.

 Slides where full manual review (FMR) is performed using either manual stage indexing, or

with the Autoscan feature should be considered as one (1) slide (as mandated by CLIA’88 for manual screening).

 Slides where both FOV review and an FMR are conducted should be considered as :

o 1.85 slides when using Sequential Modality, o 1.65 slides when using Batched Modality.

 If less than an 8-hour workday is practiced, the following formula must be applied to

determine the maximum number of slides to be reviewed during that workday:





 Note: ALL laboratories should have a clear standard operation procedure for documentation

of their method of workload counting and for establishing workload limits.

 It is the responsibility of the Technical Supervisor to evaluate and set workload limits for

individual cytotechnologists based on laboratory clinical performance.





100

MAN-05359-001 -001 Rev. 001 page 20 of 32

 Note: The manual workload limit does not supersede the CLIA requirement of 100 slides in

a 24-hour period in no less than an 8-hour day. When conducting manual review, refer to the CLIA requirements for calculating workload limits. Manual review includes the following types of slides:

o Slides reviewed on the ThinPrep Imaging System using the Autoscan feature o Slides reviewed without the ThinPrep Imaging System o Non-gynecologic slides. o According to CLIA ’88, these workload limits should be reassessed every six months.

MAN-05359-001 -001 Rev. 001 page 21 of 32

MAN-05359-001 -001 Rev. 001 page 22 of 32

Table 24. Screening Work Completion Look up Table – Integrated Imager, Sequential Modality



MAN-05359-001 -001 Rev. 001 page 23 of 32

Table 24. Screening Work Completion Look up Table – Integrated Imager, Sequential Modality, continued



MAN-05359-001 -001 Rev. 001 page 24 of 32

Table 24. Screening Work Completion Look up Table – Integrated Imager, Sequential Modality, continued



MAN-05359-001 -001 Rev. 001 page 25 of 32

Table 24. Screening Work Completion Look up Table – Integrated Imager, Sequential Modality, continued

MAN-05359-001 -001 Rev. 001 page 26 of 32

Table 25. Screening Work Completion Look up Table – Integrated Imager, Batched Modality



MAN-05359-001 -001 Rev. 001 page 27 of 32

Table 25. Screening Work Completion Look up Table – Integrated Imager, Batched Modality, continued





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Table 25. Screening Work Completion Look up Table – Integrated Imager, Batched Modality, continued





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Table 25. Screening Work Completion Look up Table – Integrated Imager, Batched Modality, continued





MAN-05359-001 -001 Rev. 001 page 30 of 32

Table 25. Screening Work Completion Look up Table – Integrated Imager, Batched Modality, continued

H. Clinical Investigation Conclusions

 When ThinPrep Integrated Imager is compared to ThinPrep Imaging System, reviewers achieved

higher sensitivity in all abnormal categories. There was some decrease in specificity.

 For ASCUS+ slides, the increase of sensitivity was 3.8% with 95% confidence interval of

2.6% to 5.0% and a decrease of specificity was -1.9% with 95% confidence interval of

-2.8% to -1.0%.

 For LSIL+ slides, the increase in sensitivity was 5.8% with 95% confidence interval of

4.1% to 7.5% and a decrease of specificity was -1.9% with a 95% confidence interval of

-2.6 to -1.2%

 For HSIL+ the increase in sensitivity was 7.9% with a 95% confidence interval of 4.5% to

11.2% and a decrease in specificity of -1.1% with a 95% confidence interval of -1.6% to

-0.6%.

 Considering the technological similarity of the ThinPrep Imaging System and the comparative

clinical study results, it is concluded that the ThinPrep Integrated Imager is similar to the ThinPrep Imaging System and may be used as replacement for manual review of ThinPrep prepared on the ThinPrep 2000 System and the ThinPrep 5000 processor for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions), and carcinoma as well as all other cytological criteria as defined by the Bethesda System.

Pap Test slides

 The screening volume for the CTs when using the Integrated Imager for the imaging and review of

slides is within the Clinical Laboratory Improvement Amendments (CLIA) guidelines for total number of slides that can be screened in one day.

 In order to increase the number of slides that can be reviewed by a cytotechnologist in one day,

slides can be imaged in advance (in batched modality) and then reviewed by the CT in a batch.

 The number of slides that a cytotechnologist can scan and review in one day is less on the Integrated

Imager than the ThinPrep Imaging System.

 Performance may vary from site to site as a result of differences in patient populations and

reading practices. As a result each laboratory using this device should employ quality assurance and control systems to ensure proper use and selection of appropriate workload limits.

 For these clinical sites and these study populations, the data from the clinical trial

demonstrate that the use of the ThinPrep Integrated Imager to assist in primary cervical cancer screening of ThinPrep

Pap Test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions, and carcinoma as well as all other cytological criteria as defined by the Bethesda System, is safe and effective for the detection of cervical abnormalities.

Bibliography

1. Nayar R, Wilbur DC. (eds). The Bethesda System for Reporting Cervical Cytology: Definitions,

Criteria, and Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015

2. Hologic, Inc. ThinPrep

number MAN-03938-001.

Imaging System Operation Summary and Clinical Information. Part

MAN-05359-001 -001 Rev. 001 page 31 of 32

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

AW-17110-001 Rev. 001

4-2018

MAN-05359-001 -001 Rev. 001 page 32 of 32

Table of Contents

Contents

Chapter One

INTRODUCTION

CONTENTS

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

SECTION G:

Chapter Two

INSTALLATION

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

SECTION G:

Overview 1.1

The ThinPrep® Imaging and Review Process 1.2

Specimen Preparation 1.5

Integrated Imager Technical Specifications 1.6

Internal Quality Control 1.10

Integrated Imager Hazards 1.11

Disposal 1.15

General 2.1

Action Upon Delivery 2.1

Preparation Prior to Installation 2.1

Moving the Integrated Imager 2.2

Connecting Integrated Imager Components 2.4

Power On the Integrated Imager 2.7

System Settings 2.9

SECTION H:

SECTION I:

SECTION J:

Chapter Three

USER INTERFACE

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

User Preferences 2.9

Storage and Handling - Post Installation 2.9

System Shutdown 2.9

Overview 3.1

Startup 3.3

Administrative Options 3.4

Main Menu 3.31

ThinPrep® Integrated Imager Operator’s Manual

CONTENTS

SECTION F:

SECTION G:

SECTION H:

Chapter Four

OPERATION

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

Chapter Five

MAINTENANCE

SECTION A:

SECTION B:

User Preferences 3.32

Save to USB 3.42

Start 3.45

Overview 4.1

Materials Required Prior to Operation 4.3

Using the Touch Screen and Review Controls 4.4

Slide Imaging 4.7

Slide Review 4.11

Review of Slides Not for Use with ThinPrep® Imaging 4.21

General Cleaning 5.1

Koehler Alignment 5.2



Chapter Six

TROUBLESHOOTING

SECTION A:

SECTION B:

SECTION C:

SECTION D:

SECTION E:

SECTION F:

Chapter Seven

SERVICE INFORMATION

Chapter Eight

ORDERING INFORMATION

INDEX

Automated Database Backup Failed 6.1

User-Initiated Database Backup Failed 6.2

Invalid Slide ID 6.3

Failed to Read Slide ID 6.3

Slide ID Mismatch While Completing the Review 6.5

Error Handling 6.6

7.1

8.1

ThinPrep® Integrated Imager Operator’s Manual

1. Introduction

INTRODUCTION

SECTION

Chapter One

Introduction

OVERVIEW

The ThinPrep® Integrated Imager is an automated cytology review microscope with ThinPrep slide imaging functionality. It is specifically designed to image and review ThinPrep Pap Test microscope slides on-demand. It also has the ability to act as a conventional microscope when not used in conjunction with ThinPrep imaging.

The Integrated Imager consists of:

The

Microscope

hand controls and adjustable touch screen user interface.

- a customized microscope with imaging camera, slide ID reader, automated stage,

Controller

Computer

, which controls the electromechanical and imaging subsystems.

with touch screen display that hosts the system application and database.

Figure 1-1 Integrated Imager

ThinPrep® Integrated Imager Operator’s Manual

1.1

INTRODUCTION

SECTION

THE THINPREP IMAGING AND REVIEW PROCESS

Imaging

A prepared ThinPrep® Pap Test microscope slide is loaded onto the stage of the device. A slide identification camera reads the slide label ID and compares it against slide IDs already in the computer database.

• If the slide ID is new, the slide is imaged.

• If the slide ID is already in the database, the software prompts for the slide to be reviewed.

• If the slide has already been reviewed, it may be reviewed again.

To ensure that the focus and light requirements for imaging are correct and will not be interrupted during the scan, the system disables any manual stage, focus and illumination controls. The instrument uses an LED light source to illuminate the optical path to image. The entire cell spot is imaged in approximately 90 integrated optical density. The coordinates of 22 of those objects are recorded and, with the slide ID, are stored in the system database. (See

seconds. The system identifies objects of interest on the slide based on

Figure 1-3.)

Review

The device next behaves as an automated microscope, presenting the 22 fields of interest to the CT (cytotechnologist) and providing additional slide review when suspect cells are found. This is termed ‘Auto Locate.’ Manual control of the stage, focus and illumination is returned for the CT’s use. The instrument uses a white LED light source for illumination for slide review. The CT interacts with the review controls both via substage hand controls and by the touch screen.

Each field of view is presented to the CT at 10X magnification. The nosepiece also has 4X and 40X objectives, which the CT can switch manually. Before the next field of view can be presented, the Integrated Imager senses if the 10X objective is engaged in the light path. If not, the system prompts the CT to return the magnification to 10X. All 22 fields of view will be presented to the CT at 10X magnification.

Note:

During slide review, the CT has the option to electronically mark an area for subsequent review and/ or physical marking. One or more electronic marks enforces a review of the entire cell spot. This is termed ‘Auto Scan.’

During Auto Scan review, the CT may add or delete electronic marks. Physical marking of these areas on the slide coverslip with a pen is done manually by the CT.

The CT has the option to control the position of the stage manually, which provides complete freedom to move any portion of the cell spot into the field of view for examination.

The object of interest is typically placed in the center of the field of view, however the CT must screen the entire field of each of the 22 fields of view presented.

1.2

ThinPrep® Integrated Imager Operator’s Manual

Cytotechnologist Actions

Integrated Imager Actions

Ready to accept next slide

Image slide

CT controls stage

Ready to remove slide

Pick next slide from tray, insert

Write up review of previous slide

Auto Locate and slide review

Scan entire cell spot and

additional slide review

Remove slide and place in tray

4. Remove

3a. Review

(abnormal only)

3. Review slide

2. Image slide

1. Insert slide

Step

INTRODUCTION

Figure 1-2 Integrated Imager Workflow

ThinPrep® Integrated Imager Operator’s Manual

1.3

A prepared ThinPrep® Pap Test slide is loaded onto the Integrated Imager stage.

The cell spot is imaged.

Slide review by the cytotechnologist.

Normal slide

The slide ID is scanned.

• If an ID is new to the database the slide will be imaged.

• An ID already in the database prompts the user to review the slide.

The slide imaging system scans the entire cell spot. The system identifies objects of interest found on the slide.

The coordinates of 22 objects of interest with the highest integrated optical density will be stored in the computer’s database.

During Auto Locate the system presents the 22 selected fields of view in geographic order to the cytotechnologist. Suspect cells may be electronically marked by the CT and a review of the entire cell spot is enforced. The slide is manually marked by the CT. At completion, the slide data is updated with the location of electronic marked areas as well as information on the review session.

Abnormal slides are reviewed by a cytopathologist for interpretation and diagnosis.

INTRODUCTION

1.4

ThinPrep® Integrated Imager Operator’s Manual

Figure 1-3 ThinPrep Imaging Process

INTRODUCTION

SECTION

SPECIMEN PREPARATION

Specimens for the ThinPrep® Pap Test cytology slide are collected by a clinician, then immersed and

rinsed in a PreservCyt laboratory equipped with a ThinPrep Processor. After being processed, the slides are stained with ThinPrep Stain and coverslipped with one of the following:

• glass coverslips, #1 thickness, 24 mm wide, 40–50 mm long

• Sakura Tissue-Tek® SCA™ coverslipped film, 45 mm long, not covering any portion of the

frosted area (Sakura part number 4770)

• Klinipath KP-Tape, 45 mm long, not covering any portion of the frosted area (Klinipath part

number 3020)

Please refer to the operator’s manuals of these instruments for more information regarding preparation and processing of ThinPrep slides.

Solution sample vial. The sample is then capped, labeled, and sent to a

Special Precautions

There are conditions that might result in a slide not being successfully imaged. Some conditions may be prevented or corrected by following these guidelines.

• ThinPrep microscope slides with fiducial marks are being used. The fiducial marks should not

be scratched or marred.

• The coverslip media is dry (wet media could cause equipment malfunction).

• The slides are clean (no fingerprints, dust, debris, bubbles). Handle the slides by the edges.

• The coverslip and the label do not extend beyond the surface of the slide.

• The slide is labeled in one of the formats supported by the ThinPrep Integrated Imager.

Specimen Integrity

PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be stored between 15°C(59°F) and 30°C (86°F) and tested within 6 weeks of collection.

Slides processed by a ThinPrep Processor should be stained within 5 days.

Stained slides should be imaged by the Integrated Imager in a timely manner, according to normal laboratory practices. Imaging performance has not been assessed beyond 4 months.

Specimen sample - the use of lubricants (e.g., KY Jelly) should be minimized prior to specimen collection. Lubricants can adhere to the filter membrane and may cause poor cell transfer to the slide.

Stain - do not substitute solutions for the ThinPrep Stain solutions. Follow the stain protocols exactly as they are written. Refer to the ThinPrep Stain User’s Manual.

Specimen Handling

The ThinPrep slides are stored, transported and handled the same as conventional cytology slides. Please refer to your laboratory guidelines for specimen handling.

ThinPrep® Integrated Imager Operator’s Manual

1.5

INTRODUCTION

SECTION

1. Eyepieces

2. Binocular tube

3. Revolving nosepiece (4X, 10X, 40X, plus position sensor)

4. Motorized stage

5. Condenser (under stage)

6. Collector

7. Coarse/fine focus knob (on left side of microscope)

8. Light intensity adjustment knob

9. X,Y axis stage control knobs (stage control)

10. Microscope power switch



(on back left of microscope with black side panel)

11. Allen screwdriver



(near the controller on the back of the microscope with the black side panel)

12. Computer

13. Touch screen interface

14. Computer power switch

15. Controller

16. Review control

17.

Note:

The “SET” button is not used.



The “LIM” button is also not used and will illuminate, with no effect, if pushed.

Revolving nosepiece

4X objective (red stripe) 10X objective (yellow stripe) 40X objective (blue stripe) 10X objective position sensor

INTEGRATED IMAGER TECHNICAL SPECIFICATIONS

Overview of Components

1.6

ThinPrep® Integrated Imager Operator’s Manual

Figure 1-4 Integrated Imager Components

Dimensions

457 mm 18 in.

609 mm 24 in.

711 mm 28 in.

INTRODUCTION

Figure 1-5 Integrated Imager Dimensions

ThinPrep® Integrated Imager Operator’s Manual

1.7

INTRODUCTION

Slide Accession ID



(OCR format shown) Fiducial mark

Fiducial mark

Frosted portion of the slide

Cell spot - contains patient

sample cells

Fiducial mark

ThinPrep® Microscope Slide for Use with the Imaging System

The ThinPrep microscope slide is used by the ThinPrep Processor in preparing the patient slide. The slide utilizes fiducial marks, or fixed reference points, which are permanently printed features on the slide that are used to register the slide position on the stage. A coordinate system is based on the fiducial marks, for locating objects of interest on the cell spot.

Weight

The Integrated Imager system - including the microscope, controller, computer and all cabling weighs approximately 32

Environmental

Operating temperature range

16°C to 32°C (60°F to 90°F)

Non-operating temperature range

-29°C to 50°C (-20°F to 122°F)

Operating humidity range

20% to 80% relative humidity, non-condensing

Non-operating humidity range

15% to 95% relative humidity, non-condensing

Pollution Degree II, in accordance with IEC 61010-1

Category II. The Integrated Imager is for indoor use only in an office or a clean laboratory environment.

Altitude

0 meters (sea level) to 2000 meters

Figure 1-6 ThinPrep Microscope Slide

kg (70 lbs.).



1.8

ThinPrep® Integrated Imager Operator’s Manual

INTRODUCTION

Atmospheric pressure

1100 millibar to 500 millibar

Sound levels

Maximum A-weighted sound pressure level at the operator’s position and at a bystander’s position

dBA.

is 66.2

Power

Voltage

100-120V~/220-240V~ single phase, 50–60 Hz

Power

Less than 150 Watts (51 2 Btu/hour) for the microscope and controller, not including the

computer

Power cables

Maximum length must be less than 3 m (9.8 ft.).

Fusing

Two 3.15A, 250 VAC, time delay, low break capacity (instrument)

Note:

Fuses are not user-accessible and are not intended to be changed by users. Contact Technical Support if the instrument does not operate. Do not remove any covers on the components.

Connections to external circuits

The external connections on the PC are PELV (Protected Extra Low Voltage) as defined by IEC

61140. Outputs of other devices connected to the PC should also be PELV or SELV (Safety Extra Low Voltage). Only devices approved for safety by an appropriate agency should be connected to the PC.

Note:

The computer manufacturer provides documentation for the PC. Refer to that for technical specifications. Do not discard.

Safety, EMI and EMC Standards

The Integrated Imager 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 model/rating label, located on the rear of the controller, to see the safety certification markings. This equipment meets the IEC 61010-2-101 particular safety requirements for IVD equipment.

This equipment meets the emission and immunity requirements of IEC 61326-2-6. This equipment has been tested and found to comply to CISPR 11 Class A emission limits.

In a domestic environment it may cause radio interference, in which case, measures to mitigate the interference may be necessary. The electromagnetic environment should be evaluated prior to operation of the equipment. Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g., unshielded RF sources), as these may interfere with the proper operation.

ThinPrep® Integrated Imager Operator’s Manual

1.9

INTRODUCTION

SECTION

This product is

This product contains a device classified per EN 60825-1 as a Class I LED product.

in vitro

diagnostic (IVD) medical equipment.

INTERNAL QUALITY CONTROL

Power On Self Test (POST)

At the time the Integrated Imager is powered on, the system goes through a self-diagnostic test. All electrical, mechanical and software/communication systems are tested to confirm each performs properly. The operator is alerted to any malfunction via a message on the user interface. If the system does not function or there are persistent errors, contact Hologic Service Information).

Post Scan Functional Checks

At the completion of slide imaging and slide review, the instrument will do functional checks to ensure integrity of the data gathered during imaging or review. The operator is alerted to any malfunction via a message on the user interface. If the system does not function or there are persistent errors, contact Hologic

Technical Support(refer to Chapter 7, Service Information).

Technical Support(refer to Chapter 7,

1.10

ThinPrep® Integrated Imager Operator’s Manual

INTRODUCTION

SECTION

INTEGRATED IMAGER HAZARDS

The Integrated Imager 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.

Do not operate the Integrated Imager with the dust cover on it.

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

•A or death.

WARNING, CAUTION

WARNING

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

and

Note

have specific meanings in this manual.

•A

CAUTION

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

•A

Note

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

advises against actions or situations that could damage equipment, produce

ThinPrep® Integrated Imager Operator’s Manual

1.11

INTRODUCTION

Symbols Used on the Instrument

The following symbols are used on this instrument:

Symbol Title Description Standard information

Caution Indicates the need for the user to

consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

In vitro diagnostic medical device

Authorized Representative in the European Community

Serial number Indicates the manufacturer’s serial

Indicates a medical device that is intended to used as an in vitro diagnostic medical device

Indicates the Authorized Representative in the European Community

number so that a specific medical device can be identified

ISO 15223-1 Medical devices—Symbols to be used with medical device labeling and information to be supplied, Section 5.4.4

ISO 15223-1 Medical devices—Symbols to be used with medical device labeling and information to be supplied, Section 5.5.1

ISO 15223-1 Medical devices—Symbols to be used with medical device labeling and information to be supplied, Section 5.1.2

ISO 15223-1 Medical devices—Symbols to be used with medical device labeling and information to be supplied, Section 5.1.7

1.12

Catalogue Number

Manufacturer Indicates the medical device

Date of manufacture

ThinPrep® Integrated Imager Operator’s Manual

Indicates the manufacturer's catalogue number so that the medical device can be identified

manufacturer, as de fined in the EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC

Indicates the date when the medical device was manufactured.

ISO 15223-1 Medical devices—Symbols to be used with medical device labeling and information to be supplied, Section 5.1.6

ISO 15223-1 Medical devices—Symbols to be used with medical device labeling and information to be supplied, Section 5.1.1

ISO 15223-1 Medical devices—Symbols to be used with medical device labeling and information to be supplied, Section 5.1.3

INTRODUCTION

Symbol Title Description Standard information

Fuse To identify fuse boxes or their loca-

tion.

And this instrument uses the following markings:

Waste Electrical and Electronic Equipment

Do not dispose in municipal waste

Contact Hologic for disposal of the instrument

On (Power switch on the microscope)

Off (Power switch on the microscope)

IEC 60417 Graphical symbols for use on equipment, symbol 5016

Lamp intensity adjustment

Stand by power (computer)

USB port icon (computer)

Ethernet port icon (computer)

Monitor display (computer)

ThinPrep® Integrated Imager Operator’s Manual

1.13

INTRODUCTION

Instrument part number label

Instrument serial number label

Model/rating label (includes these marks)

Rear of Instrument (PC removed for clarity.)

PC serial number on top (not shown)

USB port

Power

Ethernet port

USB port (5)

Front and Rear of Computer

(

Note:

The number and exact location of ports may be different, depending on the PC model you have.)

Location of Labels

Figure 1-7 Location of Labels

1.14

ThinPrep® Integrated Imager Operator’s Manual

INTRODUCTION

SECTION

Warnings Used in this Manual

WARNING: Service Installation Only. This instrument is to be installed by trained Hologic 

personnel only.

WARNING: Moving Parts. The instrument contains moving parts. Keep hands, loose clothing,

jewelry, etc., clear.

WARNING: Grounded Outlet. To ensure safe operation of the instruments, use a three-wire

grounded outlet.

WARNING: Glass. 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 when cleaning the instrument.



DISPOSAL

Disposal of consumables

Disposal of instrument fuses. No special instructions, used fuses may be disposed of in your laboratory refuse.

Broken glass. Dispose of in a sharps container.

Disposal of the device

Please contact Hologic Service (refer to Chapter 7, Service Information).

Do not dispose in municipal waste.

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Tel: 1-800-442-9892

1-508-263-2900 Fax: 1-508-229-2795 Web: www.hologic.com

ThinPrep® Integrated Imager Operator’s Manual

1.15

INTRODUCTION

This page intentionally left blank.

1.16

ThinPrep® Integrated Imager Operator’s Manual

2. Installation

Chapter Two

SECTION

Installation

INSTALLATION

WARNING:

Service Installation Only

GENERAL

The ThinPrep® Integrated Imager must be installed by Hologic service personnel. When installation is complete, Hologic personnel train the operator(s), using the operator’s manual as the training guide.

ACTION UPON DELIVERY

Remove and read the carton.

Inspect the packing cartons for damage. Report any damage immediately to the shipper and/or Hologic

Leave the instrument in the packing cartons for Hologic service installation.

Store the instrument in a suitable environment until installation (cool, dry, vibration-free area).

Technical Support as soon as possible. (Refer to Chapter 7, Service Information.)

Operating Instructions Prior to Installation

sheet attached to the packing

Note:

The computer manufacturer provides documentation for the PC. Refer to that for technical specifications. Do not discard.

PREPARATION PRIOR TO INSTALLATION

Pre-Installation Site Assessment

A pre-installation site assessment is performed by Hologic service personnel. Be sure to have prepared any and all site configuration requirements as instructed by the service personnel.

The Integrated Imager will require two outlets to power the instrument. Make sure there is adequate electrical supply within 2 meters of the instrument. It must be plugged into a three-prong grounded outlet. Disconnection from the power supply source is by removal of the power cord.

Note:

Do not position the instrument so that it is difficult to disconnect the power cords.

ThinPrep® Integrated Imager Operator’s Manual

2.1

INSTALLATION

SECTION

Location

The Integrated Imager ‘foot print’ is approximately 76.2 cm x 61 cm, and <76.2 cm high (30 in. x 24

in., and < 30 in. high). Make sure there is adequate desk space for placing slide flats or containers. (See or bench can support the weight.

Figure 2-1.) The instrument is approximately 32 kg (70 pounds). Be sure the table

CAUTION:

disconnecting cabling, do not place cabling near foot traffic.

The Integrated Imager is sensitive to vibrations. It should be placed on a flat, sturdy surface away from any vibrating equipment.

If your system is configured with the computer located separately from the microscope, be sure it is in a dust-free area, with reasonable access to the power switch.

Route connections carefully to avoid pinching the cables. To avoid tripping over, or

Figure 2-1 A Typical Integrated Imager Configuration

MOVING THE INTEGRATED IMAGER

The Integrated Imager is a precision instrument and should be handled with care. If the system must be moved, the controller and computer PC must be disconnected from one another, moved separately and reconnected at the new location.

2.2

ThinPrep® Integrated Imager Operator’s Manual

INSTALLATION

Computer AC power cord

1 (USB cable)

2 (USB cable)

3 (USB cable)

VGA (for touch screen)

Firewire (for internal camera)

4 (USB cable)

The microscope and controller are mechanically and electronically connected and should NOT be separated. The cabling between the controller and the computer may be disconnected

and reconnected, see

Before disconnecting any of the components, be sure to observe how they are originally connected. See

Figure 2-2.

Note:

The computer may be set up to face either side, or with the use of the extension cable set, it can be placed further away from the microscope and controller. Your final configuration may look slightly different than same.

Figure 2-2 Integrated Imager Interconnections

Figure 2-2. The cable connections to the computer ports remain the

ThinPrep® Integrated Imager Operator’s Manual

2.3

INSTALLATION

SECTION

The microscope should be grasped and lifted by the frame housing. Grasp the frame behind the nosepiece turret as shown in

Figure 2-3.

CAUTION:

microscope and may render it inoperable.

The instrument weighs 70 lbs. (32 kg) and should be moved by at least two people.

Lifting the instrument by the motorized stage or top cover will cause damage to the

Figure 2-3 Moving the Integrated Imager

CONNECTING INTEGRATED IMAGER COMPONENTS

The Integrated Imager components must be fully assembled before turning on the power and using the instrument. Hologic service personnel will assemble the instrument:

• Controller

• Computer

• Microscope

• Assemble spacers, trinocular head (optional telescoping head or riser)

• Eyepieces

• Objectives

• User interface touch screen and mounting rail

Controller

Computer

2.4

, which controls the electromechanical and imaging subsystems.

that hosts the system application and database.

ThinPrep® Integrated Imager Operator’s Manual

INSTALLATION

MAGNET

Open

40X

10X

MAGNET

10X

40X

20X

Front

Magnetic 10X position sensor. Do not move.

Standard Configuration for

4X, 10X and 40X

Optional Configuration for

4X, 10X, 20X and 40X

The

Microscope

stage, stage controls and touch screen interface.

The

trinocular head

camera. The light path and camera focus have been optimized by placement of spacers in the assembly of the optical components. Do not add or remove spacers or risers.

- a customized microscope with imaging camera, slide ID camera, automated

- a tilting binocular observation tube and a fixed, straight tube for the imaging

If an optional supplies.

One ocular has a diopter adjustment ring to provide common focus capability.

If the optional riser is being used, do not use it in conjunction with the telescoping head. Use one or the other, but not both.

CAUTION:

pieces or objectives.

Eyepieces

Objectives

They are specifically compatible with the supplied eyepieces and the camera for the imaging system. They should not be substituted with any other objectives.

The other object in the nosepiece is the magnetic 10X position sensor. It must not be removed.

An optional 20X objective is available. (Refer to Chapter 8, Ordering Information.) It can be installed by the operator. If the 20X objective is installed, the objectives should be positioned as shown in

telescoping head

Only use Hologic-supplied eyepieces and objective lenses. DO NOT substitute eye-

- 10X magnification with a field size of 22 mm.

- 4X, 10X and 40X objectives are mounted on the revolving nosepiece at production.

Figure 2-4.

is being used, be sure to use the specific riser that Hologic

Figure 2-4 Positions of Objectives in the Nosepiece

User interface the screen up or down along the mounting rail. The tilt and rotational angle of the screen may be adjusted by loosening the adjustment knobs, changing the tilt and rotation, and then tightening each knob.

touch screen

and mounting rail - the touch screen height can be adjusted by moving

ThinPrep® Integrated Imager Operator’s Manual

2.5

INSTALLATION

Y -Ax is tension adjustment sleeve

Y-Axis stage control X-Axis tension

adjustment sleeve X-Axis stage control

Allen screw Adjustment slot

Rotate review control

CAUTION:

Filters

the imaging is intended, do objectives.Adjusting the X,Y Axis Stage Control Knob Tension and Height

The X- and Y-axis stage control knob tension and height may be adjusted to suit the operator’s preference. See

- To ensure that the imaging camera images the cell spot at the correct gray scale for which

Do not use filters on the collector or in the objectives.

not place filters

Figure 2-5.

in the illumination path on the collector or in the

The Y-axis is adjusted by accessing the adjustment sleeve above the knob. To adjust the X-axis, pull the X- and Y-axis stage control knobs apart to reveal the adjustment sleeve of the X-axis stage control. To loosen the tension, turn the adjustment sleeves counterclockwise. For a tighter tension, turn the sleeve clockwise for either control.

To adjust the height, the X- and Y-axis stage control knobs may be slid downward or upward on the vertical axis of the assembly shaft.

Leave a small gap between the X- and Y-axis stage control knobs, to ensure there is no interference in the movement of either knob.

Adjust the Review Control Position

The Review Control may be positioned closer or further from the stage controls via an adjustment slot. See

Using the Allen screwdriver that comes with the Integrated Imager (see Figure 1-4), loosen but do not remove the Allen screw that holds the review control to the mounting bracket.

2.6

Figure 2-5 Adjust Substage Controls

Figure 2-5.

ThinPrep® Integrated Imager Operator’s Manual

INSTALLATION

SECTION

Computer power switch

Microscope power switch

Slide the review control along the slot to where it feels most comfortable for your hand position.

The review control may also be rotationally adjusted, if desired. When finished, tighten the Allen screw with the screwdriver.

POWER ON THE INTEGRATED IMAGER

WARNING:

Do not power on or operate if equipment has been damaged.

To ensure safe operation of the instrument use a three-wire grounded outlet.

Note:

It is important to apply power to the Integrated Imager system in the correct order.

1. First power on the microscope.

2. Then power on the computer.

All power cords must be plugged into a grounded outlet. Disconnection from the power supply source is by removal of the power cord.

Grounded Outlet

Figure 2-6 Power Switches

The power switch for the Integrated Imager is located on the back left of the microscope. Press the switch to the on position.

ThinPrep® Integrated Imager Operator’s Manual

2.7

INSTALLATION

Any status messages are displayed here.

System software version is displayed here.

Then press the power button on the computer. Allow the instrument to initialize. While the instrument boots up and does self checks, a splash screen is displayed, during boot up are displayed on the lower left of the screen (For example, doing self test, auto backup in process, etc.) The system software version is displayed on the lower right of the screen.

Figure 2-7. Status messages

WARNING:

The instrument is ready for use when the application main screen is displayed (Figure 2-8).

Moving Parts

Figure 2-7 Integrated Imager Startup Screen

2.8

Figure 2-8 Application Main Screen

ThinPrep® Integrated Imager Operator’s Manual

INSTALLATION

SECTION

Shut Down

button

SYSTEM SETTINGS

Refer to User Interface chapter, “System Settings” on page 3.8.

USER PREFERENCES

Refer to User Interface chapter, “USER PREFERENCES” on page 3.32.

STORAGE AND HANDLING - POST INSTALLATION

The Integrated Imager may be stored in the location where it was installed. When it is not in use, the power should be turned off. Cover the instrument with the provided microscope dust cover.

SYSTEM SHUTDOWN

Normal Shutdown

Figure 2-9 Shutdown

ThinPrep® Integrated Imager Operator’s Manual

2.9

INSTALLATION

It is important to shut down the system in the correct order. To shut down the Integrated Imager:

1. Log out if you haven’t already.

2. From the startup screen, press the

Shut Down

button in the upper right corner.

Figure 2-10 Confirm Shutdown

3. A confirmation prompt is displayed. (See Figure 2-10.)

Press the No button to cancel shutdown and return to the main screen.

4. Press the

the computer.

5. Turn off the power switch on the instrument. (See Figure 2-6.)

Extended Shutdown

If the instrument is to be shut down for an extended amount of time or be taken out of service, shut down as described in Normal Shutdown. Remove any slides that may be on the stage. Completely remove power by unplugging the controller power cord and the computer cord from the power outlet. Cover the instrument with the provided dust cover.

Yes

button to shut down the system. This will shut down the application and turn off



2.10

ThinPrep® Integrated Imager Operator’s Manual

3. User Interface

USER INTERFACE

SECTION

Password Protected

Database Backup

User Accounts

System Settings

Reports and Logs

Power On

Admin Options

Service

Manual

Review

Optionally Password Protected

Start

User

Preferences

Image Slide

Review Slide

Direction

Overlap

Autoscan Type

Autolocate Speed

Sound

Mark Indicator

Read

Slide ID

Password Settings

Chapter Three

User Interface

OVERVIEW

The ThinPrep® Integrated Imager images prepared ThinPrep Pap Test cervical cytology microscope slides. The slides are reviewed by a cytotechnologist. The instrument may also be used as a conventional microscope, for viewing slides not associated with the ThinPrep imaging process.

The Integrated Imager enables the user to administer certain functions, such as user preferences, system settings and database backup. The user interacts with the instrument via a touch screen graphic interface.

Refer to Figure 3-1 for an overview of the workflow options.

Figure 3-1 Overview of Integrated Imager Menu

ThinPrep® Integrated Imager Operator’s Manual

3.1

USER INTERFACE

This chapter introduces the user interface modules of the Integrated Imager and describes the usage of each. It is recommended that users acquaint themselves with the material in this chapter before operating the instrument.

The content found in this chapter:

STARTUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3

ADMINISTRATIVE OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4

• User Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.4

• System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.8

Date Time Lab Name Instrument Name Label Format Language

• Reports and Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.17

• Database Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.24

• Password Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.26

MAIN MENU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.31

USER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.32

• Scan Direction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.32

• Scan Overlap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3.33

• Scan Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.33

• Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.38

• Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.40

• Mark Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.41

SAVE TO USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.42

START. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.45

3.2

ThinPrep® Integrated Imager Operator’s Manual

STARTUP

SECTION

USER INTERFACE

Figure 3-2 Startup Display

When the Integrated Imager is powered on and ready for use, the screen display will appear as it does in

The options available from this interface are:

Note:

Figure 3-2.

•

Admin Options

optional password setting can be applied to access this area. Refer to OPTIONS” on page 3.4.

•

Service

•

tions. Refer to “LOGIN” on page 3.30.

•

Shut Down

on page 2.9.

•

Manual Slide Review

microscope. The stage is maneuvered by the stage control knobs. No data is retrieved or trans mitted to the database.

The Integrated Imager must be powered on to manually review slides. The light source, stage and X, Y axis stage control knobs are powered by the system controller.

- This is a password-protected module for use by Hologic service personnel only.

- Enter a user ID to access the system for ThinPrep Imaging and Slide Review func-

- System settings and user accounts are maintained from this module. An “ADMINISTRATIVE

- This is how to turn off the Integrated Imager. Refer to “SYSTEM SHUTDOWN”

- Without logging in, the user may look at slides as on a conventional

ThinPrep® Integrated Imager Operator’s Manual

3.3

USER INTERFACE

SECTION

ADMINISTRATIVE OPTIONS

Figure 3-3 Administrative Options Screen

The Administrative Options screen allows set up and customizing of the Integrated Imager. From this menu the Operator may:

• Administer User Accounts

• Apply or change System Settings

• View system logs or save them to a USB key

• Backup the system database to a CD ROM or USB key

• Apply or remove password access to the administrative options interface.

User Accounts

Figure 3-4 User Accounts Button

The User Accounts interface is used to create and retire User IDs. A User ID is required when a person presses the

button to initiate a session with the Integrated Imager.

Information associated with a User ID becomes part of the slide data record when a slide is imaged and when a slide is reviewed, using the Integrated Imager.

3.4

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

List of user accounts, with user name and ID

Add Account

, to add

an account to the list

Done

button, to return to the Admin Options screen

Save to USB

key

Enter a 3-digit ID number (from 100 to

998) using the keypad.

Note:

When the User Accounts screen is displayed, a list of all accounts that have been created is displayed: the user’s name and the login ID number. (Refer to

To maintain the integrity of the slide data records, User IDs are not to be reissued. Only unique IDs may be assigned.

Figure 3-5.)

Figure 3-5 User Accounts Display

Add account

To add a new User Account, press the Enter a unique three-digit number and touch the already assigned, an “invalid ID” message will appear and a new ID number must be entered.

Add Account

Figure 3-6 Add User Account Screen

button. A keypad display appears (Figure 3-6).

Continue

ThinPrep® Integrated Imager Operator’s Manual

button. If the desired ID number is

3.5

USER INTERFACE

If the ID number is not assigned, the next display is a keyboard for entering the name of the User Account. See

Figure 3-7.

Note:

Press the letter buttons to enter a first name. To create a capital letter, press the press the letter. With the next letter, the system reverts to lowercase. Use the and the

User ID numbers must be between the range of 100 to 998. Numbers beginning with a zero will cause errors.

User ID 999 is reserved for Hologic service personnel. Do not use this ID.

Figure 3-7 Enter User Name Screen

Space

Delete

button to remove entered letters.

Shift

button and then

button for a space

Press the button when finished to return to the User Accounts main screen. The new account will be listed. See Figure 3-8.

3.6

Continue

ThinPrep® Integrated Imager Operator’s Manual

button to continue to enter the last name using the same method. Press the

Figure 3-8 User Accounts Display

Done

USER INTERFACE

Touch the

Edit

buttons

to change the name. Touch the

Change

button to change the User ID status.

The

Delete Account

button only works if there is no slide data record associated with the account.

Save Changes

button will save changes made.

Edit/retire an account

To view or edit the status of a user account, at the User Accounts display, touch the field for that account.

Figure 3-9 Edit User Account Screen

To edit the first or last name, press the Make the desired changes and press the

To retire a User ID, touch the

Note:

The three-digit User ID cannot be changed once it is created. It can only be retired. A User Account cannot be edited or deleted once a slide data record is associated with it (by imaging or reviewing one or more slides).

Change

Edit

field on the Status line. The status will change to Retired.

field on that name. The on-screen keyboard will appear.

Done

button.



ThinPrep® Integrated Imager Operator’s Manual

3.7

USER INTERFACE

System Settings

Figure 3-10 System Settings Button

Figure 3-11 System Settings Screen

The System Settings interface allows you to set or update Integrated Imager settings. The following parameters can be set:

• Date

• Time

• Lab Name

• Instrument Name

• Label Format

• Language

3.8

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

Set date

Figure 3-12 Set Date Button

To change the date (month, day, year) touch the up/down button for that field until the desired value is displayed. Press the

Save Changes

button to return to the System Settings screen. See Figure 3-13.

Note:

Figure 3-13 Edit Date Screen

Depending on which language has been selected, the order of month and day on the display may change to reflect customary usage.

ThinPrep® Integrated Imager Operator’s Manual

3.9

USER INTERFACE

Set time

Figure 3-14 Time Button

To change the time (hour, minute, meridian), touch the up/down button for that field until the desired value is displayed. For the meridian, press the AM or PM button, as appropriate. Press the

Save Changes

button to save and return to the System Settings screen. See Figure 3-15.

Note:

Depending on which language has been selected, the clock on the display may change from 12 hour to 24 hour, to reflect customary usage.

Figure 3-15 Edit Time Screen

3.10

ThinPrep® Integrated Imager Operator’s Manual

Lab name

Keyboard Display Shift

for a capital letter

Delete

to remove entries

Switch Keys

to display keypad

Cancel

to return to System Settings screen.

Reverts to previous entr y (if any)

Continue

to save the entry and return to Sys-

tem Settings screen

Keypad Display

Type in numbers

Delete

to remove entries

Switch Keys

to display keyboard

Cancel

to return to System Settings screen.

Reverts to previous entry (if any)

Continue

to save the entry and return to Sys-

tem Settings screen

USER INTERFACE

Figure 3-16 Lab Name Button

To enter or edit a name for the facility at which the Integrated Imager is located, press the button. Press the letter buttons to enter a name, up to 20 characters long. See capital letter, press the to lowercase. Use the

Press the keyboard and keypad as often as desired before saving changes.

Switch Keys

Shift

button and then press the letter. With the next letter, the system reverts

Space

button for a space and the

button to display a keypad screen to enter numbers. Switch between

Delete

button to remove entered letters.

Figure 3-17. To create a

Lab Name

Figure 3-17 Edit Lab Name Keyboard and Keypad Screens

ThinPrep® Integrated Imager Operator’s Manual

3.11

USER INTERFACE

Press the

Note:

If a lab name is used, the name will appear on every report that is generated by the Integrated Imager (usage history, system errors). It is not necessary to enable a lab name.

Continue

Figure 3-18 Enter Lab Name Example

button to save and return to the System Settings screen.

3.12

ThinPrep® Integrated Imager Operator’s Manual

Instrument name

USER INTERFACE

Figure 3-19 Instrument Name Button

To enter or edit a name for the Integrated Imager, press the buttons to enter a name, up to 20 characters long. See

Shift

button and then press the letter. With the next letter, the system reverts to lowercase. Use the

Space

button for a space and the

Press the keyboard and keypad as often as desired before saving changes.

Press the

Switch Keys

Continue

button to save and return to the System Settings screen.

button to display a keypad screen to enter numbers. Switch between

Delete

button to remove entered letters.

Instrument Name

Figure 3-20. To create a capital letter, press the

button. Press the letter

Figure 3-20 Edit Instrument Name Screen

ThinPrep® Integrated Imager Operator’s Manual

3.13

USER INTERFACE

The Label Format button



shows the current setting.



(1-D barcode in this example).

Select

2D Barcode

label format.

Select

OCR

label format. The format is

always 14 characters long (not adjustable).

See Table 3.1, “Slide Restrictions Based on Barcode Symbology Used,” on page 3.15 for more information.

Select

1D Barcode

label format.

For the 1D barcode label format, select the 1D barcode type(s) used in your facility

Label format

Figure 3-21 Label Format Button

The camera that scans the slide label accession ID recognizes 1-dimensional or 2-dimensional barcode format (1-D or 2-D) or OCR (optical character recognition) format. It cannot use more than one format at the same time. Select the format for scanning labels and press the when done. See

Figure 3-22.

Save Changes

button

3.14

Figure 3-22 Edit Label Format Screens

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

OCR format must be 14-digits’ long in two rows, 7 digits over 7 digits, with the patient ID being 11 digits and a 3-digit CRC (which cannot be altered by the operator) at the end. The font must be 12 point OCR-A. Numbers only, no alpha characters.

Note:

Slide barcode labels may be 1- or 2-dimensional. 1-D barcodes must meet ANSI X3.182 specifications with a quality of grade B or better. See the table below for any restrictions. Slide labels may be printed and applied or directly printed or etched onto the slide. (See sure the contrast is sufficient for the scanner to read the label.

For OCR format, ‘9999’ as the last 4 digits before the CRC are reserved for field service use. Slide IDs with those reserved numbers are removed from the patient database during a ser vice visit, so do not use that sequence.

Figure 3-23.) In any case, make

Table 3.1: Slide Restrictions Based on Barcode Symbology Used

1-D Code 128 All printable ASCII 128 characters are supported. The barcode width

varies with content. Minimum of 5 mum of 8 alphas or 14 digits will fit on a slide. Mixing will shorten the max length.

1-D Interleaved 2 of 5 Only digits are supported. 5,7,9, or 11 characters +1 (optional) check

digit is the format.

1-D Code 39 Supported characters are A–Z, 0–9, - + . $ / % ‘space’ Minimum

of 5

characters is required and maximum of 6 characters will fit on a

slide. (A single character check digit is optional.)

1-D Code 93 All printable ASCII 128 characters are supported. A minimum of

characters is required and a maximum of 8 characters will fit on a

slide.

characters is required and maxi-

2-D datamatrix All printable ASCII 128 characters are supported. A maximum of

characters is supported.

ThinPrep® Integrated Imager Operator’s Manual

3.15

USER INTERFACE

1-Dimensional barcode examples

2-D barcode



example

OCR format

Figure 3-23 Examples of Barcodes on a ThinPrep Slide

Language

Press the and on the reports.

3.16

Language Settings

ThinPrep® Integrated Imager Operator’s Manual

Figure 3-24 Language Settings Button

button to change the language that is displayed on the user interface

USER INTERFACE

Press the button for the desired user interface language and press

Done

to apply it. (English is selected in this display.)

Cancel

button, to quit the language screen and return to the Settings display . No changes apply.

Figure 3-25 Select Language Screen

Press the button for the desired language, and press the

Reports and Logs

The Reports and Logs interface presents system information in three forms:

• System Errors - a log of all of the 200 most recent system errors, from oldest to most recent.

• Usage History - Lists the number of slides imaged and reviewed on the Integrated Imager

• Slide search - a specific slide ID or range of IDs and the associated slide data can be found in

Done

button to immediately apply the setting.

Figure 3-26 Reports and Logs Button

After 200 errors have been logged, the newest are added and the oldest are purged.

the database using this search.

ThinPrep® Integrated Imager Operator’s Manual

3.17

USER INTERFACE

Instrument name Usage summary

Slides imaged



(system total including fai lures) Slides imaged successfully Slides reviewed (system total)

Done

button, to return to



System Settings screen

Figure 3-27 Reports and Logs Screen

System errors

The System Errors report displays all of the error conditions encountered during slide imaging and review (200 are stored at one time). See Use the up/down arrows to scroll through the list using the touch screen. To download this report, place a USB key in the appropriate port of the computer and press the

Figure 3-28 System Errors Report Button

Figure 3-29. The events are listed from most recent to oldest.

Save to USB

button.

3.18

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

Current date Software version

Scroll button

Save to USB

Instrument name

List of system events

Done

button, to return to Reports and Logs screen

Figure 3-29 System Events Report Screen

Usage history

The Usage History report provides a Summary or a Detailed report of all activity on the Integrated Imager within a specific time period.

Press the period or for a one-day time period. See

Usage History

Figure 3-30 Usage History Report Button

button. First you will select if the usage history report is for a one-week time

Figure 3-31.

ThinPrep® Integrated Imager Operator’s Manual

3.19

USER INTERFACE

Weekly History Screen

Select which week to view by touching on any week.

Use the scroll arrow to change to a different month.

Press

Done

to view the

report.

Daily History

button, to switch to Daily History screen

Daily History Screen

Select which day to view by touching the date.

Use the scroll arrow to change to a different month.

Press

Done

to view the

report.

Weekly History

button, to switch to Weekly History screen

Press the The default view is the Usage Summary screen. It can be changed to the Usage Details screen.

Figure 3-31 Weekly/Daily History Selection Screens

Done

button on the History screen to generate the report, displayed on the following page.

3.20

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

Summary Screen

The time period for this summary

Summary of slides imaged Summary of slides

reviewed

Done

button, to return to

Reports and Logs screen

Cancel

button, to return to Calendar Screen

Scroll to different week (or day)

View Details

changes display to Details screen

Save to USB

Figure 3-32 Usage Summary Screen (A Weekly History is Shown)

The Usage Summary screen lists a total of all slides imaged in that week (or day) and how many of those slides were imaged successfully.

Note:

The Review Summary lists:

This summary may be saved to a USB key by pressing the

A detailed list of the slides reviewed is displayed by pressing the following section.

Slides not imaged successfully may have failed due to a biological quality which prevented successful imaging, or a fiducial mark error or a system error. Cancellation by the operator during imaging is not included in the total.

• All users logged on to the Integrated Imager that week (or day)

• How many slides in total were reviewed

• How many slides were Auto Locate only in the “FOV Only” column (fields of view presented

by the Integrated Imager)

• How many slides were a full slide review in the “Full Review” column (Auto Locate plus

Auto Scan of the entire cell spot)

Save to USB

View Details

button.

button. Refer to the

ThinPrep® Integrated Imager Operator’s Manual

3.21

USER INTERFACE

Details Screen

The time period for this summary

Individual slides listed

Done

button, to return to

Reports and Logs screen

Cancel

button, to return to Reports and Logs screen

Scroll to different week (or day)

View Summary

changes display to Summary screen

Save to USB

Figure 3-33 Usage Detail Screen (A Weekly History is Shown)

The Usage Details displays all slide review activity for that week (or day). For every slide, it lists:

• The slide ID number

• Date and time the slide was imaged

• The status of the image (OK or Fail)

• The user ID (who was logged into the Integrated Imager)

• Date and time the review took place (the time being the completion time)

• Full review of the slide conducted ( )

This summary may be saved to a USB key by pressing the

Slide search

A specific slide number or range of slide numbers can be searched for in the database. After pressing

Slide Search

the

3.22

Figure 3-34 Slide Search Report Button

button, a keypad will display. See Figure 3-35.

ThinPrep® Integrated Imager Operator’s Manual

Save to USB

button.

USER INTERFACE

Cancel

button, to return to

Reports and Logs screen

Enter a slide ID via the keypad.

Switch Keys

button, to display keyboard to enter letters

Press

Continue

perform the search.

Instrument name Number(s)

searched for Slide data

Done

button, to return to Reports and Logs screen

Report date Number of

matches found in the database

Save to USB

Figure 3-35 Enter Slide ID to Begin Search

To search for a specific slide, enter the slide ID using the keypad buttons. Switch between keypad and keyboard, if the ID contains alpha and numeric characters. Press the ready to perform the search.

To search for a range of slides, enter the first digits of the slide ID that they have in common. For

Done

example, enter “01234” and then press the

The database retrieves the slide ID or range of IDs and lists them as shown below, Figure 3-36.

Figure 3-36 Slide Search Report Screen

button.

Continue

button when

The slide IDs are listed with any available data for that ID:

ThinPrep® Integrated Imager Operator’s Manual

3.23

USER INTERFACE

Press

Cancel

to cancel the backup and return to the Administrative Options screen.

Select the media type,

USB

• The slide ID number

• Date and time the slide was imaged

• The status of the image (“OK” for successful; “Fail” for unsuccessful)

• The user ID (who was logged onto the Integrated Imager)

• Full review of the slide conducted - yes or no

This summary may be saved to a USB key by pressing the

Save to USB

button.

Database Backup

The Integrated Imager automatically makes a scheduled backup of the database every night at 2:00

am. If the instrument is turned off, then a backup of the database is made the next time it is

turned on, if 2:00 am has passed. The automatic backup is stored internally in the system.

If desired, the operator can make a backup of the database onto a CD ROM or USB key.

Figure 3-37 Database Backup Button

From the Administrative Options screen, touch the screen.

Database Backup

button to display the backup

3.24

Figure 3-38 Database Backup, Select Backup Type

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

Press

Cancel

to cancel the backup and return to the Administrative Options screen.

After loading a blank CD or a USB storage device into the drive, press

Continue

CD drive door

CD release button

Mount the CD on the



spindle in the drive (shiny side facing the drive mechanism).

USB ports (The ports may be located differently, depending on the computer model you have.)

Figure 3-39 Database Backup Screen

To open the CD drive, press the release button on the drive door. (See Figure 3-40.)

As prompted, insert a blank disk into the CD drive and close the door, or insert a USB storage device into a USB port. The Integrated Imager will back up to the first USB storage device detected by the Integrated Imager. It is recommended to have only one USB device connected to the Integrated Imager at a time.

Note:

Figure 3-40 USB and CD: Open CD Drive - Insert Disc

The CD drive of this computer only writes to a CD ROM (do not use a DVD disc, the system will not recognize it).

The CD ROM must be blank, or the system will reject it. You cannot accumulate backups onto a single disk. The USB storage device, however, does not need to be blank. The USB storage device only needs adequate space to store the database backup.

ThinPrep® Integrated Imager Operator’s Manual

3.25

USER INTERFACE

(Backup to CD shown)

Press the completed message when finished. See

The Integrated Imager can use another USB storage device to save reports. Refer to “SAVE TO USB” on page 3.42.

Refer to the Chapter 6, Troubleshooting, if any other messages display during backup.

Continue

button. The system checks the media, writes the data and displays a backup

Figure 3-41.

Password Settings

3.26

Figure 3-41 Database Backup

Figure 3-42 Password Settings Button

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

Button to enable password

Password

Disabled

Done

button, to accept changes and return to Administrative Options screen

Cancel

, to return to Administrative Options screen. Revert to what was previously set

Password will be present here when it is enabled.

Enter a password via keyboard.

Cancel

, to return to System Settings screen. Revert to what was previously set

Continue

to the

next step.

An administrative password may be set to limit access to the Administrative Options screen. Only by entering the correct password can the screen be displayed and used.

Press the

Password Settings

To Set a Password

button to display the Password screen (Figure 3-43).

Figure 3-43 Password Settings Screen

Press the The word may be up to 20 alpha characters long and it is case-sensitive.

Press the visible in the password field.

Enabled

Continue

Figure 3-44 Password Settings Keyboard

button. The keyboard screen will appear and prompt for a password to be entered.

button and the display returns to the Password Settings screen. The password is

ThinPrep® Integrated Imager Operator’s Manual

3.27

USER INTERFACE

Cancel

, to return to System Settings screen

Password now enabled

Change

button, to alter or remove the password

Done

button, to accept changes and return to System Settings screen

Figure 3-45 Password Enabled

Once Admin Options screen is exited, the system displays a keyboard and prompts for a password to access that screen again. See

If the password is lost or forgotten, contact Hologic Technical Support (Chapter 7, Service Information).

Figure 3-46.

Figure 3-46 Password Required

3.28

ThinPrep® Integrated Imager Operator’s Manual

USER INTERFACE

Cancel

button, to abandon changes and return to the previous screen

Disabled

button will remove password requirement to access Admin Options.

Done

button, to accept changes and return to Admin Options

Change a Password

Enter the Admin Options screen by entering the required password. Press the button to view the password screen. (See

Figure 3-45.)

Password Setting

Press the button to set the new password and return to the System Settings screen.

Change

button and type the new word using the keyboard that appears. Press the

Remove a Password

To remove a password, access the Admin Options screen using the current password. At the Password Settings screen, press the change.

Disabled

button. Then press the

Done

button to accept the

Done

Note:

Figure 3-47 Disable the Password

The password is removed. If an admin password is used later, the password has to be set up again, as described in

“To Set a Password” on page 3.27.

ThinPrep® Integrated Imager Operator’s Manual

3.29

USER INTERFACE

SECTION

Enter the three-digit operator ID to access the system.

Use the

Delete

key to clear incorrect numbers.

Cancel

button, to cancel and return to the Startup Display

Press

Continue

button after entering operator ID.

To access the Imaging and Slide Review functions of the Integrated Imager, a three-digit operator ID must be entered.

Press the digits on the display keypad, and touch

Use the

Cancel

As soon as the number is entered, the system database checks that it is a valid operator ID. Any user preferences that have been saved with that ID will be active.

The message “Invalid User ID” might occur if the three-digit number was entered incorrectly, if there is no user ID with that number, or if that number has been retired.

See “Add account” on page 3.5 for creating a user ID.

See “User Preferences” on page 3.32 for selecting user preferences.

3.30

Figure 3-48 Login Screen

Delete

button.

ThinPrep® Integrated Imager Operator’s Manual

key to clear mistakes. To cancel login and return to the startup screen, press the

Continue

when done.

MAIN MENU, (Logged In)

SECTION

The name of the user The date and time that

the user logged in

User Preferences



button selects settings for slide review.

Logout

button, log out and return to the Startup Display.

Start

button, to begin operating the Integrated Imager

USER INTERFACE

Successful login will display the main screen. The name of the user who logged in is shown on the screen. Just below the name is the date and time that login started. While a user is logged in, the system will revert to the main screen after completing any services (slide imaging & review, setting preferences). The options available from this interface are:

•

Figure 3-49 Main Menu Screen

User Preferences

for automated slide review, such as scan direction, overlap, type, speed and sound alerts. Refer to

Start

ton. Refer to Chapter 4, Operation.

Logout

will return to the Startup screen. The instrument may be powered off or a user may log in to begin a new session.

“USER PREFERENCES” on page 3.32.

- to begin using the Integrated Imager to image and review a slide, press the

- to end the session with the Integrated Imager, press the

- this module allows the cytotechnologist to adjust some of the parameters

Start

but-

Logout

button. The system

ThinPrep® Integrated Imager Operator’s Manual

3.31

USER INTERFACE

SECTION

User preferences

Save Changes

, to save changes and return to main screen

Cancel

, to abandon any changes and return to main screen

Reset to Default

returns settings to factory default.

USER PREFERENCES

The User Preferences allow the cytotechnologist to customize preferences for Slide Review. These are settings for direction of scan, overlap, Auto Scan and maximum speed for Auto Locate, plus audible beep volume and mark indicator. Once settings have been adjusted, they will remain from session to session until they are changed again. The preferences are associated with each user ID. If there are multiple users of an Integrated Imager, the preferences associated with the ID the will be uploaded at Login.

Auto Scan Settings

Direction

The direction of the stage movement during Auto Scan may be selected. Press the to toggle between the choices of Direction Up-Down or Direction Left-Right. ( the selection through the eyepieces, ensure the 10X objective is in position, load a slide in the slide holder for reference, and press the

Figure 3-50 User Preferences Screen

Figure 3-51 Select Stage Movement Direction

Preview

button.

Direction

Figure 3-51.) To view

button

3.32

ThinPrep® Integrated Imager Operator’s Manual

Hologic ThinPrep Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual