Hologic Rapid fFN 10Q User manual

User Manual

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IMPORTANT: Read the entire manual before operating the Rapid fFN® 10Q System.
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Tel: For Technical Support (USA and Canada)
1-800-442-9892
Fax: [phone]
Tel: For Technical Support (Outside the USA and Canada)
Asia [phone] Netherlands: 0800 022 6782
Australia: [phone] Norway: 800 155 64
Austria: 0800 291 919 Portugal: 800 841 034
Belgium: 0800 773 78 Spain: 900 994 197
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Ireland (Rep): 1 800 554 144 Rest of the world: 00800.800.442.9892
Italy: 800 786 308 Intl Fax number: 0041.21.633.39.10
©2019 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.
The Rapid fFN® 10Q Analyzer is covered by U.S. patent number 6,267,722. The Rapid fFN® 10Q QCette is covered by U.S. patent number Des. 432,244.
The Hologic logo, Rapid fFN® 10Q, and Rapid fFN® 10Q QCette are trademarks and/or registered trademarks of Hologic, Inc.
Printed in the USA AW-19875-001 Rev. 001 8-2019
Hologic BVBA
Da Vincilaan 5
1930 Zaventem
Belgium

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Rapid fFN 10Q System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
I Introduction
• Intended Use 1-1
• General Description 1-1
• Components of the Analyzer 1-2
• Keypad 1-3
• Cassette Insertion Site 1-4
• Displayed/Printed Results 1-5
• Specifi cations 1-6
• Cautions and Warnings 1-8
2 Installation
• General 2-1
• Environmental Factors 2-1
• Unpacking 2-2
• System Setup 2-4
• Getting Started 2-6
• Setting the Date and Time 2-7
• Factory Default Settings 2-8

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Rapid fFN 10Q System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
• Shutdown 2-8
• Extended Shutdown 2-8
3 General Operating/Testing Instructions
• Starting the System 3-1
• Overview of Rapid fFN 10Q Analyzer Menu 3-2
• Typical Menu Item Sequences 3-3
• Key to User Entry Fields 3-4
• Keypad Functions 3-5
• Keypad Entries 3-6
• Daily QC - Quick Reference 3-11
• Test Patient - Quick Reference 3-12
• Set Calibration - Quick Reference 3-14
• Liquid Controls - Quick Reference 3-15
4 Software Functions – Detailed Descriptions
• Startup Screen 4-1
• Main Menu 4-2
• Set Calibration 4-3

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Rapid fFN 10Q System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
• Test Patient 4-6
• Daily QC 4-12
• Liquid Controls 4-16
• Access Data 4-21
• View/Print Data 4-21
• Data Transfer 4-23
• View Setup 4-24
• Change Setup 4-25
• Date/Time 4-25
• Autoprint 4-28
• Rapid fFN QCette Setup 4-29
• Software Update 4-33
• Test Counts 4-34
• Usage Report 4-35
5 Care of the Analyzer
• General Cleaning 5-1
• Cleaning of Cassette Insertion Site 5-1
• Cleaning Agents Approved for Use 5-1

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Rapid fFN 10Q System User Manual
Table of Contents
TABLE OF CONTENTS
Section Page
6 Printer
• Loading Printer Labels 6-1
• Removing an Empty Label Roll 6-4
• Clearing Label Jams 6-5
7 Troubleshooting
• General Information 7-1
• Troubleshooting Table 7-1
• Error/Invalid Codes 7-10
8 Service and Warranty
• Technical Support 8-1
• Contact Information — Technical Support 8-1
• Replacement Parts 8-3
• Contact Information — fFN Customer Service 8-4
• Warranty 8-5

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
SECTION I — INTRODUCTION
For In Vitro Diagnostic Use Only
To be used by trained medical personnel
INTENDED USE
The Hologic Rapid fFN® 10Q System is an in vitro diagnostic device intended to be used in conjunction with the
Rapid fFN 10Q Cassette, the Rapid fFN Control Kit, and the Rapid fFN 10Q QCette for the detection of fetal
fi bronectin (fFN) in cervicovaginal secretions. Refer to the directional insert for the Rapid fFN 10Q Cassette for
detailed intended use information.
GENERAL DESCRIPTION
The Rapid fFN 10Q Analyzer is an electronic optical refl ectance 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 0–500 ng/mL. Concentrations greater than 500 ng/mL are
reported as >500 ng/mL. The result is reported as invalid if specifi c internal test criteria have not been met.

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
COMPONENTS OF THE ANALYZER
The major components of the analyzer are the display screen, the keypad, and the cassette insertion site.
Display Screen
Cassette
Insertion Site
Keypad

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
KEYPAD
Numeric — Use keypad to enter numerical characters from 0 to 9.
Alpha — Use keypad to enter alpha characters from A to Z.
Functions — Up, down, left, right arrows act as function keys to move through the
menus and select options.
DELETE, ESC (escape), SPACE, PRINT/ENTER function keys provide further
functionality for using the menu options.
See Chapter 3, General Operating, for a full description of using the keypad.

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
CASSETTE INSERTION SITE
The Cassette Insertion Site contains a slightly concave trough designed to capture any fl uids that may have been
spilled while applying sample to the Rapid fFN 10Q Cassette. This area of the instrument should be cleaned
regularly (see Section 5, Care of the Analyzer).
Note: Insert a Rapid fFN 10Q Cassette or Rapid fFN 10Q QCette only.