Hologic TLi IQ User Manual

User Manual

System

i

Hologic Inc.
250 Campus Drive
Marlborough, MA 01752 USA
TEL: For Technical Support (US A a nd Cana da)
1-888-PRETERM (1-888-773-8376)
1-800-442-9892
FAX: [phone]
TEL: For Technical Support (Outside the USA and Canada)

Asia [phone]

Australia: [phone]
Austria: 0800 291 919
Belgium: 0800 773 78
Denmark: 8088 1378
Finland: 0800 114 829
France: 0800 913 659
Germany: 0800 183 0227
Ireland (Rep): 1 800 554 144
Italy: 800 786 308

Netherlands: 0800 022 6782

Norway: 800 155 64
Portugal: 800 841 034
Spain: 900 994 197
South Africa: 0800 980 731
Sweden: 020 797 943
Switzerland: 0800 298 921
UK: 0800 032 3318
Rest of the world: 0041.21.633.39.26
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 TLi

IQ

System is covered by U.S. patent numbers 6,267,722 and 6,394,952. The TLiIQ Analyzer is covered by U.S. patent number

Des. 434,153. The Cassette Housing is covered by U.S. patent number Des. 432,244.
The Hologic logo, TLiIQ, and TLiIQ QCette are registered trademarks of Hologic Inc.

Printed in the USA 06023-001 Rev 001

Hologic UK
Link 10 Napier Way
Crawley, West Sussex
R

H10 9RA UK

[phone]

IMPORTANT: Read the entire manual before operating the TLi

IQ

®

System.

TLiIQ System User Manual ii

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 of a Class B digital device, pursuant to Part 15 of the
FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to
radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.
Increase the separation betw een the equ ipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/television technician for help.

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.

TLiIQ System User Manual iii

CE Notice:

This equipment has been tested and found to be in compliance with the following standards per the IVD Directive:
EN61326-1 Electrical Equipment for Measurement, Control and Laboratory Use

EN55011 Radiated and Conducted Emissions
EN61010-1 Safety Requirements
EN61000-3-2 Harmonic Emissions
EN61000-3-3 Voltage Fluctuations
EN61000-4-2 Electrostatic Discharge
EN61000-4-4 Electrical Fast Transients
EN61000-4-5 Voltage Surges
EN61000-4-6 Conducted Immunity
EN61000-4-11 Voltage Interrupts

TLiIQ System User Manual iv

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 c us tomer, 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:

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.

Do not dispose in municipal waste.

Contact Hologic (see below) for information

regarding proper disposal.

TLiIQ System User Manual v

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

FAX: [phone]

Authorized

Representative - Europe

HOLOGIC (UK) LIMITED

UNIT 2, LINK 10
NAPIER WAY
CRAWLEY, WEST SUSSEX RH10 9RA
UNITED KINGDOM
Tel: [phone]

FAX: [phone]

TLiIQ System User Manual vi

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 18°C and 30°C

Catalog number

For in vitro diagnostic testing

TLiIQ System User Manual vii
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

• Keypad Functions 1-3

• Keypad Entries 1-6

• Cassette Insertion Site 1-11

• Displayed/Printed Results 1-12

• Specifications 1-17

• Cautions and Warnings 1-19

2 Installation

• General 2-1

• Environmental Factors 2-1

• Unpacking 2-2

• System Setup 2-4

TLiIQ System User Manual viii
Table of Contents

Section Page

• Getting Started 2-5

• Setting the Date and Time 2-6

• TLi

IQ

QCette® Setup 2-7

• Factory Default Settings 2-8

3 General Operating/Testing Instructions

• Starting the System 3.1

• Set Calibration 3-2

• Test Patient 3-4

• Daily QC 3-7

• Liquid Controls 3-9

• Viewing Results On-Screen 3-12

• Incubation Mode 3-13

• Internal Mode 3-13

• External Mode 3-14

4 Software Functions – Detailed Descriptions

• Startup Screen 4-1

• Main Menu 4-2

TLiIQ System User Manual ix
Table of Contents

Section Page

• Set Calibration 4-3

• Test Patient 4-5

• Daily QC 4-10

• Liquid Controls 4-14

• Access Data 4-19

• View/Print Data 4-19

• Data Transfer 4-21

• View Setup 4-23

• Change Setup 4-24

• Date/Time 4-24

• Autoprint 4-27

• Incubation Mode 4-28

• TLi

IQ

QCette® Setup 4-29

• Test Counts 4-33

5 Care of the Analyzer

• General Cleaning 5-1

• Cleaning of Cassette Insertion Site 5-1

• Cleaning Agents Approved for Use 5-1

TLiIQ System User Manual x
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 7-7

8 Service and Warranty

• Technical Service 8-1

• Contact Information - Technical Service 8-1

• Replacement Parts 8-2

• Contact Information - fFN Customer Service 8-2

• Warranty 8-3

TLiIQ System User Manual 1 – 1
Section 1 – Introduction

SECTION I – INTRODUCTION

For In Vitro Diagnostic Use Only

To be used by trained laboratory personnel

INTENDED USE

The Hologic TLi

IQ

®

System is intended to be used in conjunction with the Rapid fFN Cassette, the Rapid fFN Control Kit,

and the TLi

IQ

QCette® for the detection of fetal fibronectin in cervicovaginal secretions. Refer to the directional insert for

the Rapid fFN Cassette for detailed intended use information.

GENERAL DESCRIPTION

The TLi

IQ

®

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 provides one of three possible patient test results: Positive, Negative, or Invalid.

The result is positive if the signal intensity derived from the patient sample is greater than or equal to the reference
calibration value sp ecified by the calibration code. The result is negative if the signal intensity derived from the p atient
sample is less than the reference calibration va lue specified by the calibrat ion code. The result is reported as invalid if
specific internal test criteria have not been met.

TLiIQ System User Manual 1 – 2
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

TLiIQ System User Manual 1 – 3
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.

KEYPAD FUNCTIONS
(Vertical Scroll )

Alpha characters - Use ↑ ↓ to navigate through the alphanumeric keys when selecting
an alpha character.

Scrolling through Data Records - Use ↑ ↓ when scrolling through data records in
ACCESS DATA mode.

Menu Screens - Some menus require up to three screens to display all of the options.
Use

↑ ↓

to go to the next or previous screen of the menu.

TLiIQ System User Manual 1 – 4
Section 1 – Introduction

(Left Arrow Key)

Previous Page - Use ← to go to the previous page within a data record.
Delete - Use DELETE to delete characters to the left of the cursor.

(Right Arrow Key)

Next Page - Use → to go to the next page within a data record.
Space - Use SPACE to enter a space in the position of the cursor.

TLiIQ System User Manual 1 – 5
Section 1 – Introduction

(Print/Enter Key)

Accept/Confirm - Press ENTER to accept or confirm an entry in any data entry field.
Print - Press PRINT to print a data record.

This print function is only active when a data record is on the display screen.

(Escape Key)

Press ESC to return to the most recent Menu screen, unless otherwise specified. If ESC
is pressed in any screen requiring data entry, all entries will revert to the previous setting.

TLiIQ System User Manual 1 – 6
Section 1 – Introduction

KEYPAD ENTRIES

Entries of numerical characters require pressing the appropriate numeric key.
Entries of alpha characters require pressing the numeric key containing the alpha character and the ↑ or ↓ arrows (scroll

keys).

TLiIQ System User Manual 1 – 7
Section 1 – Introduction

Example - to enter Cassette Lot Number C9123.
1 - Press 2. Use ↑ arrow until C appears on the display screen.
NOTE: The ↑ arrow will scroll repetitively through the characters 2-A-B-C. The ↓ arrow will scroll repetitively through the

characters 2-C-B-A.

2 - Press 9.

CASSETTE LOT #

>2

ENTER - ACCEPT

CASSETTE LOT #

>C

ENTER - ACCEPT

CASSETTE LOT #

>C9

ENTER - ACCEPT

TLiIQ System User Manual 1 – 8
Section 1 – Introduction

3 - Press each subsequent number 1, 2, 3.

4 - Press ENTER after all entries have been made.

CASSETTE LOT #

>C912_

ENTER - ACCEPT

CASSETTE LOT #

>C9123

ENTER - ACCEPT

TLiIQ System User Manual 1 – 9
Section 1 – Introduction

Example - to enter Patient Name ABE
1 - Press 2. Use ↑ or ↓ arrow until A appears on the display screen.

2 - Press 2 again. Use ↑ or ↓ arrow until
B appears on the display screen.

PATIENT ID

>2

ENTER - ACCEPT

PATIENT ID

>A

ENTER - ACCEPT

PATIENT ID

>A2

ENTER - ACCEPT

PATIENT ID

>AB

ENTER - ACCEPT

TLiIQ System User Manual 1 – 10
Section 1 – Introduction

3 - Press 3 to enter the next letter. Use ↑ or ↓ arrow until E appears on the display screen.

4 - Press ENTER after all entries have been made.

PATIENT ID

>AB3

ENTER - ACCEPT

PATIENT ID

>ABE

ENTER - ACCEPT

TLiIQ System User Manual 1 – 11
Section 1 – Introduction

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 Cassette. This area of the instrument should be cleaned regularly (see Section 5).

TLiIQ System User Manual 1 – 12
Section 1 – Introduction

DISPLAYED/PRINTED RESULTS

Each test result is displayed on the analyzer display screen. A test result requires three screens to display all of the data
associated with the result. With AUTOPRINT ON, the test result is autom atic all y printed. Eac h print ed result requires one
printer label. Results can be printed from any data record screen either immediately after a test or in DATA ACCESS
mode.

Example: Displayed/Printed Results of Calibration Record

Displayed Printed

CAL CODE:FG56

CASSETTE LN:L1002
ANALYZER ID:01701

ESC-MAIN MENU ←

FETAL FIBRONECTIN

02:10 PM 10/26/07

SYSTEM CALIBRATED

USER:XXXXXXXXXXXX→

TLiIQ System User Manual 1 – 13
Section 1 – Introduction

Example: Displayed/Printed Re sults of TLi

IQ

QCette®

Displayed Printed

QCette

02:40 PM 10/26/07
SYSTEM: PASS
USER:XXXXXXXXXXXX →

CAL CODE:FG56

QCette SN:004640
ANALYZER ID:01701

ESC-MAIN MENU ←

TLiIQ System User Manual 1 – 14
Section 1 – Introduction

Example: Displayed/Printed Re sults of Negative Control Record

Displayed Printed

CAL CODE:FG56

CASSETTE LN:L1002
ANALYZER ID:01701
ESC-MAIN MENU ←

INTERNAL CONTROLS

USER:XXXXXXXXXXXXXX
ANALYZER: PAS S

CASSETTE: PASS ← →

FETAL FIBRONECTIN

02:45 PM 10/26/07
NEG CTL:M1023
RESULT:PASS →

TLiIQ System User Manual 1 – 15
Section 1 – Introduction

Example: Displayed/Printed Re sults of Patient Record

Displayed Printed

CAL CODE:BB11

CASSETTE LN:A2222
ANALYZER ID:01701
ESC-MAIN MENU ←

USER:XXXXXXXXXXXX

INTERNAL CONTROLS

ANALYZER: PASS

CASSETTE: PASS ← →

FETAL FIBRONECTIN

03:02 PM 10/26/07
PT:XXXXXXXXXXXXXXXX
RESULT:POSITIVE →

TLiIQ System User Manual 1 – 16
Section 1 – Introduction

Example: Displayed/Printed Re sults of Test Counts Record

Displayed Printed

PATIENT:4

CONTROL:1
QCette:1

FETAL FIBRONECTIN

TEST COUNTS
03:03 PM 10/26/07

ANALYZER:01701 →

TLiIQ System User Manual 1 – 17
Section 1 – Introduction

SPECIFICATIONS

Power Supply UL 12 VDC listed power supply
Memory Capacity

50 Calibration Records
50 QCette Records
50 Control Records
50 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

TLiIQ System User Manual 1 – 18
Section 1 – Introduction

Dimensions

Length - 8.9 inches
Width - 6.9 inches
Height - 1.0 to 3.0 inches
Weight - 1.2 pounds

Operating Temperature

18° to 30°C
64° to 86°F

A.C. Supply 120VAC / 60Hz / 16W

or
220VAC / 50Hz / 16W

Input Connector Coaxial power plug with positive center conductor
Output Connectors 9 pin male and 9 pin female data connectors

TLiIQ System User Manual 1 – 19
Section 1 – Introduction

CAUTIONS AND WARNINGS
There are no known hazards associated with the TLi

IQ

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 a grounded 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 unp lug the power adapter before c leaning 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.