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
Denmark: 8088 1378 South Africa: 0800 980 731
Finland: 0800 114 829 Sweden: 020 797 943
France: 0800 913 659 Switzerland: 0800 298 921
Germany: 0800 183 0227 UK: 0800 032 3318
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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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.

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
DISPLAYED/PRINTED RESULTS
Each menu function result is displayed on the analyzer display screen. A result may require one or more screens
to display all of the data associated with the result. With AUTOPRINT 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
Rapid fFN 10Q
03:00 PM 10/26/13
PT:JANE DOE 123
fFN:160 ng/mL
CAL CODE:95HYA-76YTT
CASSETTE LN:L1002
ANALYZER ID:G0237
ESC-MAIN MENU
USER:JOHN SMITH
ANALYZER QC: PASS
CASSETTE QC: PASS
HOLOGIC Rapid fFN®
Rapid fFN 10Q RESULT
fFN CONC: 160 ng/mL
TIME: 03:00 PM DATE: 10/26/13
PATIENT: JANE DOE 123
USER: JOHN SMITH
CASSETTE LOT: L1002
CALIBRATION CODE: 95HYA-76YTT
ANALYZER ID: G0237
INTERNAL CONTROLS
ANALYZER QC: PASS
CASSETTE QC: PASS
Displayed Printed

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Section 1 — Introduction
SPECIFICATIONS
Power Supply UL 15 VDC listed power supply
Memory Capacity 50 Calibration Records
50 QCette Records
50 Control Records
1000 Patient Records
Display 4 lines
20 characters per line
Alphanumeric 5 x 8 matrix Supertwist LCD
Black characters with gray background
Keypad 3.5 x 4.5 inches
Tactile membrane
Alphanumeric keys

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
Dimensions Length — 8.9 inches
Width — 6.9 inches
Height — 1.0 to 3.0 inches
Weight — 1.56 pounds
Operating Temperature 15° to 30°C
59° to 86°F
Operating Humidity 20% to 80%, non-condensing
A.C. Supply 100-240VAC
50-60 Hz
0.7A
Input Connector Coaxial power plug with positive center conductor
Output Connectors 9 pin data connector
2 host USB connectors

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
CAUTIONS AND WARNINGS
There are no known hazards associated with the Rapid fFN 10Q System when it is operated in accordance
with the instructions in this manual. However, you should be aware of situations that can result in serious injury.
WARNING! Ensure that the analyzer power adapter is connected to an AC electrical outlet that
provides voltage and current specifi ed by Hologic. Use of an incompatible power receptacle can
cause shock and fi re hazard.
CAUTION! Use only the power adapter supplied by Hologic. Use of an incompatible power adapter can
damage the internal components.
CAUTION! Always turn off the power and unplug the power adapter before cleaning the exterior of the
analyzer. Fluid can damage internal components. DO NOT clean the power adapter.
CAUTION! Extreme heat can damage the display and other electronic components.

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
WARNING! Never apply cleaning reagents by spray as the liquid may leak into the analyzer
causing damage to the electrical components or possibly electrical shock to the user.
CAUTION! Do not immerse the analyzer in liquid. Fluid can damage internal components.
CAUTION! Do not clean the keypad with undiluted bleach solution or other solvents. Caustic cleaning
solutions can damage the keypad.
CAUTION! Use appropriate laboratory procedures for handling biohazardous materials.

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Section 1 — Introduction
10
If this equipment is used in a manner not specifi ed by the manufacturer, then the protection provided by the
equipment may be impaired.
FCC Notice:
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part
15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause
harmful interference in which case the user will be required to correct the interference at his own expense.
FCC Warning:
Changes or modifi cation not expressly approved by the manufacturer responsible for compliance could void
the user’s authority to operate the equipment.
Note: The use of a non-shielded interface cable with this equipment is prohibited.
CE Notice:
This equipment has been tested and found to be in compliance with the following standards per the IVD Directive:
EN61326-2-6 Electrical Equipment for Measurement, Control and Laboratory Use; EMC Requirements;
In Vitro Diagnostic (IVD) Medical Equipment.

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Section 1 — Introduction
11
EN61010-2-101 Electrical Equipment for Measurement, Control and Laboratory Use; Part 101; Particular
Requirements for In Vitro Diagnostic (IVD) Medical Equipment.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference. The electromagnetic environment should be
evaluated prior to operation of the device.
Do not use this device in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
This equipment also complies with the following safety standards:
UL61010-1 Safety Requirements for Electrical Equipment for Laboratory Use Part 1: General
Requirements, with an ETL or equivalent Approval Mark
ICES-003 Industry Canada Regulation: Interference-Causing Equipment Standards -
Digital Apparatus
CAN/CSA C22.2 No. 61010-2-101
Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory
Use - Part 1: General Requirements, with ETL or equivalent Approval Mark

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Section 1 — Introduction
Disposal of Electrical & Electronic Equipment
Waste Electrical and Electronic Equipment (WEEE)
Hologic is dedicated to meeting country specifi c requirements associated with the environmentally sound
treatment of our products. Our objective is to reduce the waste arising from our electrical and electronic
equipment. Hologic realizes the benefi ts of subjecting such WEEE equipment to potential reuse, treatment,
recycling or recovery to minimize the amount of hazardous substances entering the environment.
Your Responsibility
As a Hologic customer, you are responsible for ensuring that devices marked with the symbol shown below are
not placed into the municipal waste system unless authorized to do so by the authorities in your area. Please
contact Hologic (see below) prior to disposing any electrical equipment provided by Hologic.
Symbol Used on the Instrument
The following symbol is used on this instrument: Do not dispose in municipal waste.
Contact Hologic (see below) for information
regarding proper disposal.
Reclamation
Hologic will provide for the collection and proper reclamation of electrical devices we provide to our customers.
Hologic strives to reuse Hologic devices, subassemblies, and components whenever possible. When reuse is not
appropriate, Hologic will ensure the waste material is properly disposed of.

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Section 1 — Introduction
Hologic Contact Information
Corporate Headquarters Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Tel: (USA and Canada)
1-800-442-9892
1-508-263-2900
Fax: [phone]
Authorized
Representative - Outside of U.S.
Hologic BVBA
Da Vincilaan 5
1930 Zaventem
Belgium

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Rapid fFN 10Q System User Manual
Section 1 — Introduction
Symbols Used on the Instrument
The following symbols are used on this instrument:
Warning, refer to
accompanying documents.
Manufactured by
Waste Electrical and Electronic
Equipment - contact Hologic
for disposal of the instrument.
Authorized Representative in
the European Community
Lot Store between 15°C and 30°C
Catalog Number For in vitro diagnostic testing
Serial Number