Hologic PERILYNX Manuale utente
User Manual
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IMPORTANT: Read the entire manual before operating the PeriLynx™ System
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Tel: For Technical Support (USA and Canada)
1-888-PRETERM (1-888-773-8376)
1-800-442-9892
Fax: 1-508-263-2967
Tel: For Technical Support (Outside the USA and Canada)
Asia +852 3526 0718 Netherlands: 0800 0226782
Australia: +61 2 9888 8000 Norway: 800 15564
Austria: 0800 291919 Portugal: 800 841034
Belgium: 0800 77378 Spain: 900 994197
Denmark: 8088 1378 South Africa: 0800 980 731
Finland: 0800 114829 Sweden: 020 797943
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Germany: 0800 1830227 UK: 0800 0323318
Ireland (Rep): 1 800 554144 Rest of the world: 00800.800.29892
Italy: 800 786308 Intl Fax number: 0041.21.633.39.10
©2016 Hologic, Inc. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any
means in whole or in part without the prior written permission of Hologic, Inc.
This product may be covered by one or more U.S. patents identified at http://hologic.com/patentinformation. Hologic, PeriLynx, Rapid fFN, and QCette
are trademarks and/or registered trademarks of Hologic, Inc. and/ or its subsidiaries in the United States and/or other countries. All other trademarks,
registered trademarks and product names are the property of their respective owners.
English AW-14693-001 Rev. 001 4-2016
Hologic Ltd.
Heron House, Oaks Business
Park, Crewe Road, Wythenshawe,
Manchester, M23 9HZ, UK
+44 (0)161 946 2206
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PeriLynx™ System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
Section 1 — Introduction 1-1
Intended Use 1-1
General Description 1-1
Components of the Analyzer 1-2
Touch screen 1-2
Cassette insertion site 1-2
Displayed/Printed Results 1-3
Specications 1-4
Cautions and Warnings 1-6
Disposal of Electrical & Electronic Equipment 1-10
Symbols Used on the Instrument 1-12
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PeriLynx™ System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
Section 3 — General Operating/Testing Instructions 3-1
Starting the System 3-1
Overview of PeriLynx Analyzer Main Menu 3-2
Typical Menu Item Sequences 3-3
Using the Touch Screen 3-4
Run QCette QC — Quick Reference 3-8
Test Patient — Quick Reference 3-9
Enter New Calibration Code — Quick Reference 3-11
Run Liquid QC — Quick Reference 3-12
Section 4 — Software Functions — Detailed Descriptions 4-1
Startup Screen 4-1
Main Menu 4-2
Enter New Calibration Code 4-3
Test Patient 4-6
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PeriLynx™ System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
Run QCette QC 4-15
Liquid Controls 4-20
Adjust Settings 4-28
Adjust Settings — Date/Time 4-28
Adjust Settings — Sound Settings 4-30
Adjust Settings — Auto Print 4-31
Adjust Settings — Password Settings 4-32
Adjust Settings — QCette Setup 4-35
Adjust Settings — Update Software 4-41
View Reports 4-42
Monthly Usage 4-42
Test Counts 4-44
Access Data 4-45
Access Data — View/Print Data 4-45
Access Data — Data Transfer 4-47
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PeriLynx™ System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
Section 5 — Care of the Analyzer 5-1
Section 6 — Printer 6-1
Loading Printer Labels 6-1
Removing an Empty Label Roll 6-4
Clearing Label Jams 6-5
Section 7 — Troubleshooting 7-1
General Information 7-1
Error/Invalid Codes 7-10
Section 8 — Service 8-1
Technical Support 8-1
Replacement Parts 8-3
1-1
PeriLynx™ System User Manual
Section 1 — Introduction
Section 1 — Introduction
For In Vitro Diagnostic Use Only
To be used by trained medical personnel
Intended Use
The Hologic PeriLynx™system is an in vitro diagnostic device intended to be used in conjunction with the
RapidfFN®10Q cassette, the RapidfFN® control kit, and the PeriLynx™QCette®for the detection of fetal
fibronectin (fFN) in cervicovaginal secretions. Refer to the directional insert for the Rapid fFN 10Q cassette for
detailed intended use information.
General Description
The PeriLynx™ analyzer is an electronic optical reflectance device that converts a colorimetric reaction from
a cassette into a digitized format. The data are analyzed using multiple parameters, including a comparison of
sample data to calibration data. The analyzer reports the fFN concentration in the clinical specimen.
The analyzer reports fFN concentrations ranging from 0–500ng/mL. Concentrations greater than 500ng/mL are
reported as >500ng/mL. The result is reported as invalid if specific internal test criteria have not been met.
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PeriLynx™ System User Manual
Section 1 — Introduction
Touch screen
Use the touch screen to enter data, select options, and
move through the menus.
See Section 3 — General Operating/Testing Instructions,
for a full description of using the touch screen.
Cassette insertion site
The Cassette Insertion Site contains a slightly concave
trough designed to capture any fluids that may have been
spilled while applying sample to the cassette. This area of
the instrument should be cleaned regularly (see Section
5 — Care of the Analyzer).
Note: For the detection of fetal fibronectin (fFN)
in cervicovaginal secretions, insert a
RapidfFN10Q Cassette or PeriLynx QCette
only.
Components of the Analyzer
The major components of the analyzer are the touch screen and the cassette insertion site.
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PeriLynx™ System User Manual
Section 1 — Introduction
Displayed/Printed Results
Each menu function result is displayed on the analyzer touch screen. With Auto Print ON, the result is
automatically printed. Each printed result requires one printer label. Results can be printed from any data record
screen either immediately after a test or in Access Data mode. The example below demonstrates the display and
printout of a patient test.
Example: Displayed/Printed Results of Patient Test
Displayed Printed
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