RapidfFN 10Q System User Manual Rev 001 Jan 2013

User Manual

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) 1-888-PRETERM (1-888-773-8376) 1-800-442-9892 Fax: 1-508-263-2967 Tel: For Technical Support (Outside the USA and Canada)

Hologic UK Ltd Link 10 Napier Way Crawley, West Sussex RH10 9RA UK +44 (0) 1293 522 080

Asia

+852 3526 0718

Netherlands:

0800 022 6782

Australia:

+61 2 9888 8000

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

©2013 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-09188-001 Rev. 001 1-2013 i

TABLE OF CONTENTS Section I

2

Page

Introduction • Intended Use • General Description • Components of the Analyzer • Keypad • Cassette Insertion Site • Displayed/Printed Results • Specifications • Cautions and Warnings

1-1 1-1 1-2 1-3 1-4 1-5 1-6 1-8

Installation • General • Environmental Factors • Unpacking • System Setup • Getting Started • Setting the Date and Time • Factory Default Settings

2-1 2-1 2-2 2-4 2-6 2-7 2-8

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TABLE OF CONTENTS Section • • 3

4

Page Shutdown Extended Shutdown

2-8 2-8

General Operating/Testing Instructions • Starting the System • Overview of Rapid fFN 10Q Analyzer Menu • Typical Menu Item Sequences • Key to User Entry Fields • Keypad Functions • Keypad Entries • Daily QC - Quick Reference • Test Patient - Quick Reference • Set Calibration - Quick Reference • Liquid Controls - Quick Reference

3-1 3-2 3-3 3-4 3-5 3-6 3-11 3-12 3-14 3-15

Software Functions – Detailed Descriptions • Startup Screen • Main Menu • Set Calibration

4-1 4-2 4-3

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TABLE OF CONTENTS Section • • • •

Test Patient Daily QC Liquid Controls Access Data • View/Print Data • Data Transfer View Setup Change Setup • Date/Time • Autoprint • Rapid fFN QCette Setup • Software Update Test Counts Usage Report

4-6 4-12 4-16 4-21 4-21 4-23 4-24 4-25 4-25 4-28 4-29 4-33 4-34 4-35

Care of the Analyzer • General Cleaning • Cleaning of Cassette Insertion Site • Cleaning Agents Approved for Use

5-1 5-1 5-1

• •

• • 5

Page

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TABLE OF CONTENTS Section 6

7

8

Page

Printer • Loading Printer Labels • Removing an Empty Label Roll • Clearing Label Jams

6-1 6-4 6-5

Troubleshooting • General Information • Troubleshooting Table • Error/Invalid Codes

7-1 7-1 7-10

Service and Warranty • Technical Support • Contact Information - Technical Support • Replacement Parts • Contact Information - fFN Customer Service • Warranty

8-1 8-1 8-3 8-4 8-5

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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 fibronectin (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 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 0–500 ng/mL. Concentrations greater than 500 ng/mL are reported as >500 ng/mL. The result is reported as invalid if specific internal test criteria have not been met.

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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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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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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 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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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 USER:JOHN SMITH ANALYZER QC: PASS CASSETTE QC: PASS

CAL CODE:95HYA-76YTT CASSETTE LN:L1002 ANALYZER ID:G0237 ESC-MAIN MENU

Displayed Rapid fFN 10Q System User Manual Section 1 - Introduction

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

Printed 1–5

SPECIFICATIONS Power Supply Memory Capacity

UL 15 VDC listed power supply 50 Calibration Records 50 QCette Records 50 Control Records

Display

1000 Patient Records 4 lines 20 characters per line Alphanumeric 5 x 8 matrix Supertwist LCD

Keypad

Black characters with gray background 3.5 x 4.5 inches Tactile membrane Alphanumeric keys

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Dimensions

Length - 8.9 inches Width - 6.9 inches Height - 1.0 to 3.0 inches

Operating Temperature

Weight - 1.56 pounds 15° to 30°C

Operating Humidity A.C. Supply

59° to 86°F 20% to 80%, non-condensing 100-240VAC 50-60 Hz

Input Connector Output Connectors

0.7A Coaxial power plug with positive center conductor 9 pin data connector 2 host USB connectors

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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 specified by Hologic. Use of an incompatible power receptacle can cause shock and fire 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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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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If this equipment is used in a manner not specified 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 modification 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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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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Disposal of Electrical & Electronic Equipment Waste Electrical and Electronic Equipment (WEEE) Hologic is dedicated to meeting country specific 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 benefits 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. Rapid fFN 10Q System User Manual Section 1 - Introduction

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Hologic Contact Information Corporate Headquarters

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 USA Tel: (USA and Canada) 1-888-PRETERM (1-888-773-8376) 1-800-442-9892 1-508-263-2900 Fax: 1-508-263-2967

Authorized Representative - Outside of U.S.

Hologic UK Limited Unit 2, Link 10 Napier Way Crawley, West Sussex RH10 9 RA United Kingdom Tel: +44 1293 522 080 Fax: +44 1293 528 010

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