Hologic ThinPrep 5000 Bedienungsanleitung

Operator’s Manual

ThinPrep®5000 Processor with AutoLoader

ThinPrep

™

5000 Processor

with AutoLoader

Operator’s Manual

For Use With Version 2.x.y Software MAN-07494-002

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

Hologic BV

Da Vincilaan 5

1930 Zaventem

Belgium

Australian Sponsor:

Hologic (Australia and

New Zealand) Pty Ltd

Suite 302, Level 3

2 Lyon Park Road

Macquarie Park NSW

2113

Australia

Tel: 02 9888 8000

UK Responsible

Person:

Hologic, Ltd.

Oaks Business Park

Crewe Road

Wythenshawe

Manchester M23 9HZ

United Kingdom

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

™

5000 processor.

Preparation of microscope slides using the ThinPrep 5000 processor should be performed only by

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

Hologic.

Evaluation of microscope slides produced with the ThinPrep 5000 processor should be performed only

by cytotechnologists and pathologists who have been trained to evaluate ThinPrep-prepared slides by

Hologic or by organizations or individuals designated by Hologic.

transcribed, stored in a retrieval system, or translated into any language or computer language, in any

form, or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise,

without the prior written permission of Hologic, 250 Campus Drive, Marlborough, Massachusetts,

01752, United States of America.

Although this guide has been prepared with every precaution to ensure accuracy, Hologic assumes no

liability for any errors or omissions, nor for any damages resulting from the application or use of this

information.

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

patentinformation.

Hologic, CytoLyt, PreservCyt, ThinPrep, and UroCyte are registered trademarks of Hologic, Inc. and/

or its subsidiaries in the United States and/or 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-22290-002 Rev. 003

1-2022

Revision History

Revision Date Description

AW-22290-002 Rev. 001 11-2020 Clarify instructions. Add instructions regarding reporting serious

incidents. Remove urine collection kit information.

AW-22290-002 Rev. 002 4-2021 Replace CE mark. Remove reference to hologic.com/package-

inserts. Add UKCA mark.

AW-22290-002 Rev. 003 1-2022 Administrative change

This page intentionally left blank.

Instructions For Use

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 1/36

ThinPrep™ 5000 System

Instructions for Use

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 2/36

INTENDED USE

The ThinPrep 5000 Processor is part of the ThinPrep System. It is used to prepare ThinPrep

microscope slides from ThinPrep PreservCyt vials for use as a replacement for the conventional

method of Pap smear preparations for screening for the presence of atypical cells, cervical

cancer, or its precursor lesions (Low-grade Squamous Intraepithelial Lesions, High-grade

Squamous Intraepithelial Lesions) as well as all other cytologic categories as defined by The

Bethesda System for Reporting Cervical Cytology. Also for preparation of ThinPrep slides from

non-gynecologic (non-gyn) samples, including urine samples. For professional use.

SUMMARY AND EXPLANATION OF THE SYSTEM

The ThinPrep process begins with the patient’s gynecologic sample being collected by the

clinician using a cervical sampling device which, rather than being smeared on a microscope

slide, is immersed and rinsed in a vial filled with 20 ml of PreservCyt™ Solution (PreservCyt). The

ThinPrep sample vial is then capped, labeled, and sent to a laboratory equipped with a ThinPrep

5000 Processor.

At the laboratory, the PreservCyt sample vial is bar-coded along with the test request form to

establish a sample chain of custody and is placed into a ThinPrep 5000 Processor. A glass slide

bearing the same sample identification number as on the sample vial is loaded into the

Processor. A gentle dispersion step mixes the cell sample by currents in the fluid that are strong

enough to separate debris and disperse mucus, but gentle enough to have no adverse effect on

cell appearance.

The cells are then captured on a Gynecological ThinPrep Pap Test Filter that is specifically

designed to collect cells. The ThinPrep 5000 constantly monitors the rate of flow through the

ThinPrep Pap Test Filter during the collection process in order to prevent the cellular

presentation from being too scant or too dense. A thin layer of cells is then transferred to a glass

slide in a 20 mm-diameter circle, and the slide is automatically deposited into a fixative solution.

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 3/36

The ThinPrep Sample Preparation Process

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

The sample vial is rotated,

creating currents in the fluid that

are strong enough to separate

debris and disperse mucus, but

gentle enough to have no

adverse effect on cell

appearance.

A gentle vacuum is created within

the ThinPrep Pap Test Filter, which

collects cells on the exterior

surface of the membrane. Cell

collection is controlled by the

ThinPrep 5000 Processor’s

software that monitors the rate of

flow through the ThinPrep Pap Test

Filter.

After the cells are collected on

the membrane, the ThinPrep Pap

Test Filter is inverted and gently

pressed against the ThinPrep

Microscope Slide. Natural

attraction and slight positive air

pressure cause the cells to

adhere to the ThinPrep

Microscope Slide resulting in an

even distribution of cells in a

defined circular area.

As with conventional Pap smears, slides prepared with the ThinPrep™ 5000 System are examined

in the context of the patient’s clinical history and information provided by other diagnostic

procedures such as colposcopy, biopsy, and human papillomavirus (HPV) testing, to determine

patient management.

The PreservCyt™ Solution component of the ThinPrep 5000 System is an alternative collection

and transport medium for gynecologic specimens tested with the Digene Hybrid Capture

System HPV DNA and Hologic APTIMA COMBO 2™ CT/NG Assays. Refer to the respective

manufacturer’s package inserts for instructions for using PreservCyt Solution for collection,

transport, storage, and preparation of specimens for use in those systems.

The PreservCyt Solution component of the ThinPrep 5000 System is also an alternative

collection and transport medium for gynecologic specimens tested with the Roche Diagnostics

COBAS AMPLICORTM CT/NG assay. Refer to Hologic’s labeling (Document #MAN-02063-001) for

instructions for using PreservCyt Solution for collection, transport, storage, and preparation of

ThinPrep™ 5000 System Instructions for Use English AW-22289-001 Rev. 003 11-2021 4/36

specimens and to the Roche Diagnostics COBAS AMPLICOR CT/NG package insert for

instructions for use of that system.

If any serious incident occurs related to this device, or any components used with this device,

report it to Hologic Technical Support and the competent authority local to the user and/or

patient.

LIMITATIONS

•Gynecologic samples collected for preparation using the ThinPrep 5000 System should

be collected using a broom-type or endocervical brush/plastic spatula combination

collection devices. Refer to the instructions provided with the collection device for

warnings, contraindications, and limitations associated with specimen collection.

•Preparation of microscope slides using the ThinPrep 5000 System should be performed

only by personnel who have been trained by Hologic or by organizations or individuals

designated by Hologic.

•Evaluation of microscope slides produced with the ThinPrep 5000 System should be

performed only by cytotechnologists and pathologists who have been trained to evaluate

ThinPrep prepared slides by Hologic or by organizations or individuals designated by

Hologic.

•Supplies used by the ThinPrep 5000 System are those designed and supplied by Hologic

specifically for the ThinPrep 5000 System. These include PreservCyt Solution vials,

ThinPrep Pap Test Filters, and ThinPrep Microscope Slides. Alternative collection media,

filters, and slides have not been validated by Hologic and may lead to erroneous results.

Hologic does not provide a warranty for results using any of these alternatives. Product

performance may be compromised if supplies that have not been validated by Hologic

are used. After use, supplies should be disposed of in accordance with local, state, and

federal regulations.

•A ThinPrep Pap Test Filter must be used only once and cannot be reused.

•The performance of HPV DNA and CT/NG testing on sample vials reprocessed with

glacial acetic acid (GAA) has not been evaluated.

CONTRAINDICATIONS

•Chlamydia trachomatis and Neisseria gonorrhoeae testing using the Hologic APTIMA

COMBO 2™ CT/NG and the Roche Diagnostics COBAS AMPLICOR assays should not be

performed on a sample that has already been processed using the ThinPrep 5000

processor.

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