Hologic PERILYNX, LABELWRITER450 TURBO User Manual

User Manual

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: [phone]
Tel: For Technical Support (Outside the USA and Canada)

Asia [phone] Netherlands: 0800 0226782

Australia: [phone] 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

France: 0800 913659 Switzerland: 0800 298921

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

i

Hologic Ltd.
Heron House, Oaks Business
Park, Crewe Road, Wythenshawe,
Manchester, M23 9HZ, UK
[phone]

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

Specications 1-4

Cautions and Warnings 1-6

Disposal of Electrical & Electronic Equipment 1-10

Symbols Used on the Instrument 1-12

PeriLynx™ System User Manual
Table of Contents

ii

TABLE OF CONTENTS

Section Page

Section 2 — Installation 2-1

General 2-1

Environmental Factors 2-1

Unpacking 2-2

System Setup 2-5

Getting Started 2-7

Setting the Date and Time 2-9

Factory Default Settings 2-10

Shutdown 2-11

Extended Shutdown 2-11

PeriLynx™ System User Manual
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iii

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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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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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

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vi

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
RapidfFN®10Q cassette, the RapidfFN® 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 0–500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.

PeriLynx™ System User Manual
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1-1

Components of the Analyzer

The major components of the analyzer are the touch screen and the cassette insertion site.

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
RapidfFN10Q Cassette or PeriLynx QCette
only.

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1-2

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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1-3

Specifications

Power Supply UL +24 VDC listed power supply

Memory Capacity 50 Calibration Records

50 QCette Records

50 Control Records

1000 Patient Records

Touch screen 5-inch diagonal display with 480 x 800 resolution and

256 colors. Resistive interface.

Dimensions Length — 10 inches (25.4 cm)

Width — 7.5 inches (19.05 cm)

Height — 4 inches (10.16 cm)

Weight — 2.4 pounds (1090 g)

Operating Temperature 15° to 30°C

59° to 86°F

Operating Humidity 20% to 80%, non-condensing

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Sound level, analyzer Maximum A-weighted sound pressure level at the typ-

ical user’s position and at a radius of 1 meter around
the analyzer is 56 dB.

A.C. Supply 100-240VAC

50-60 Hz

2.1A
Input Connector Coaxial power plug with positive center conductor
Output Connectors 9-pin RS-232 connector

3 host USB connectors

Ethernet connector

Printer power connector

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Cautions and Warnings

There are no known hazards associated with the PeriLynx 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 touch screen display with undiluted bleach solution or other solvents. Caustic

cleaning solutions can damage the touch screen.

CAUTION! Use appropriate laboratory procedures for handling biohazardous materials.

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.

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1-7

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.
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.

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1-8

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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1-9

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.

PeriLynx™ System User Manual
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1-10

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: [phone]

Authorized Representative in the
European Community

PeriLynx™ System User Manual
Section 1 — Introduction

Hologic Ltd.
Heron House, Oaks Business Park
Crewe Road, Wythenshawe
Manchester, M23 9HZ, UK
Tel: [phone]

1-11

Symbols Used on the Instrument

30˚C

15˚

The following symbols may appear on this instrument or its packaging:

Caution, consult instructions for
use

Waste Electrical and Electronic
Equipment - contact Hologic for
disposal of the instrument.

Catalogue Number

Serial Number Biological risks

For in vitro diagnostic testing Direct current (DC)

PeriLynx™ System User Manual
Section 1 — Introduction

Manufacturer

Authorized Representative in
the European Community

Store between 15°C and

C

30°C

1-12

Section 2 — Installation

General

This section provides detailed installation instructions for the PeriLynxsystem. Follow installation steps carefully
to insure proper installation and operation.

Environmental Factors

The PeriLynxsystem has been designed to be safe under the following conditions:

• Indoor use;

• Altitudes up to 2000 m;

• Maximum relative humidity of 80% for temperatures up to 30°C;

• Pollution Degree II, in accordance with IEC 61010-1 Category II. The PeriLynx system is for use only in an

ofce or a clean laboratory environment.

• The operating temperature should be held relatively constant. The optimum operating temperature is 15° to
30°C (59° to 86°F). Before operating, allow the instrument to equilibrate to room temperature.

Place the instrument away from direct sunlight and away from locations subject to extreme temperature
variations (e.g., near open windows, ovens, hot plates, radiators, etc.).

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Unpacking

PeriLynxanalyzer

Carefully remove the analyzer and
accessories from the shipping carton.

Inspect the carton and the analyzer for visible
signs of damage. If the analyzer is damaged,
immediately contact the carrier and Hologic
Customer Service.

The carton should contain the following
parts/accessories:

• PeriLynx analyzer

• AC adapter and power cord (one or more for
international compatibility)

• User manual

• PeriLynx QCette

®

Note: Retain the shipping carton for future use. If the analyzer needs to be

shipped, use the original shipping carton.

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Printer

Carefully remove the printer and accessories from the
shipping carton. Inspect the carton and the printer for
visible signs of damage. If the printer is
damaged, immediately contact the carrier
and Hologic Customer Service.

The printer carton should contain the
following parts/accessories:

• Printer

• Printer labels (1 roll)

• Power cord

• USB cable

Note: Retain the shipping carton for future use. If the

printer needs to be shipped, use the original
shipping carton.

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Barcode scanner (optional)

A barcode scanner is available from Hologic for entering data into the analyzer.
This barcode scanner is the only barcode scanner for use with the PeriLynx
system. If your order included the optional barcode scanner, carefully remove
the barcode scanner and accessories from the shipping carton. Inspect the
carton and the barcode scanner for visible signs of damage. If the barcode
scanner is damaged, immediately contact the carrier and Hologic Customer
Service.

Follow all of the instructions provided by the barcode scanner manufacturer
regarding the safe use of the barcode scanner.

The barcode scanner carton should contain the following parts/accessories:

• Barcode scanner

• Stand

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System Setup

1. The analyzer and printer should be placed on a flat, level surface. Verify that the power switch on the back
of the analyzer is set to the off (0) position.

Note: Do not install any of the Dymo Label software that comes with the printer.

2. Plug the power cable jack into the receptacle labeled 24V DC on the bottom of the printer. Plug the other
end of the cable into the PeriLynxanalyzer.

3. Insert the USB cable into the receptacle labeled USB on the bottom of the printer. Route the USB cable
and the power cable through the cable channel and set the printer upright on a flat surface. Plug the other
end of the USB cable into any of the USB ports on the analyzer.

System

(Photo includes optional barcode scanner)

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Printer

Analyzer

2-5

4. Use the AC cord corresponding to the room power outlets. Plug the output jack from the power adapter
into the rear of the analyzer. Plug the wall mount adapter into an AC power outlet.

Caution: Only the power adapter provided with the PeriLynxanalyzer may be used. Any substitutions can

result in damage to the PeriLynxanalyzer and printer.

5. To connect the optional barcode scanner, plug the USB cable of the scanner into any of the USB ports on
the analyzer.

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2-6

Getting Started

Turn the analyzer power switch to the on ( l ) position. The power switch is located on the back of the
instrument. (If the analyzer does not turn on, see Section 7 — Troubleshooting, Item 1.)

Upon power up, the analyzer displays the Hologic logo and then PeriLynxsystem logo with the message
“Initializing system...” for 60 seconds. Then, the analyzer performs a self-test of the analyzer components.

If there is a problem after the self-test, a
beep will sound to indicate an error and
an error message will be displayed. If an
error message is displayed, refer to the
troubleshooting section of the manual.

If the printer is not connected, an error
message will be displayed.

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Once the self-test is complete, the display will change to the Main Menu. The date and time may need to be
reset for your time zone.

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Setting the Date and Time

1. From the Main Menu, select Adjust Settings.

2. Touch Date/Time Settings and follow the prompts.

For more details about setting the date and time, see Section 4 — Software Functions — Detailed Descriptions.

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2-9

Factory Default Settings

The PeriLynxsystem uses the following default settings. To customize the unit to your laboratory requirements,
refer to Section 4 — Software Functions — Detailed Descriptions.

The default settings are as follows:

Auto Print

Factory setting is

Auto Print

ON. After every result, the printer will generate a printed result.

Date format

The default setting is MM/DD/YY.

Time format

The default setting is 24 hour time.

Sound settings

The default setting is for the audible tone (beep) to be turned on at a volume of 5.

Password settings

The default setting has the password disabled.

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Shutdown

The system may be left plugged in and idle when not in use. If the system is to be shut down make sure it is idle.
Move the power switch on the back of the analyzer to the off position.

Extended Shutdown

If the system is to be turned off for a long period of time, or taken out of use, power off the analyzer as
described above. Completely remove power from the device by unplugging the power cord from the electrical
outlet.

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