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.

TLiIQ System User Manual 1 – 20
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.

TLiIQ System User Manual 2 – 1
Section 2 – Installation

SECTION 2 – INSTALLATION

GENERAL

This section provides detailed installation instructions for the TLi

IQ

System. Follow installation steps carefully to insure

proper installation and operatio n.

ENVIRONMENTAL FACTORS

The TLi

IQ

System has been designed to be safe under the following conditions: Indoor use; Altitudes up to 2000m;
Maximum relative humidity of 80% for temperatures up to 31°C decreasing linearly to 50% relative humidity at 40°C; Main
supply voltage fluctuations not to exceed ± 10% of the nominal; transient overvoltages according to Installation Category
and Pollution Degree 2. However, as with all electronic instruments, prolonged exposure to high temperature and humidity
should be avoided. The operating temperature should be held relatively constant. The optimum operating temperature is
18° to 30°C (64° to 86°F). Before operating, allow the instrument to equilibrate to room temperature.

Place the instrument where it will not be subjected to extreme temperature variations (e.g., near open windows, ovens,
hot plates, radiators, direct sunlight).

TLiIQ System User Manual 2 – 2
Section 2 – Installation

UNPACKING

TLi

IQ

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:

• TLi

IQ

Analyzer

• Power Ad apt er

• User Manual

• TLi

IQ

QCette®

NOTE: Retain the shipping carton for future use. If the
analyzer needs to be shipped, use the original shipping
carton.

TLiIQ System User Manual 2 – 3
Section 2 – Installation

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 (2 rolls)

• Power Cor d

• Printer Cable

NOTE: Retain the shipping carton for future use.
If the printer needs to be shipped, use the
original shipping carton.

TLiIQ System User Manual 2 – 4
Section 2 – Installation

SYSTEM SETUP

1. The Analyzer and Printer should be placed on a flat, level surface.

2. Connect the 9-pin connector of the printer cable to the analyzer and the modular jack to the printer.

System Printer Analyzer

3. Connect the small connector of the analyzer power adapter to the analyzer and the larger power connector to a

grounded AC electrical outl et. Caution: Only power connectors provided with the TLi

IQ

analyzer and printer may be

used. Any substitutions can result in damage to the TLi

IQ

analyzer and printer.

4. Connect the small connector of the printer power cord to the printer and the larger connector of the power cord to a

grounded AC electrical outl et.

TLiIQ System User Manual 2 – 5
Section 2 – Installation

GETTING STARTED

Turn the analyzer power switch to the ON position. The power switch is located on the left side of the instrument. (If the
analyzer does not turn on, see Section 6, Troubleshooting.)

The analyzer will perform SYSTEM DIAGNOSTICS (a s elf -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 code will be displayed. If an error code is displayed,
refer to the troubleshooting section of the manual.

Once SYSTEM DIAGNOSTICS is complete, the display will change to the software VERSION, DATE, and TIME for five
seconds, and then to the fFN Main Menu. The date and time may need to be reset for your time zone.

HOLOGIC TLi SYSTEM

VERSION 2.0

SYSTEM DIAGNOSTICS

IN PROCESS

HOLOGIC TLi SYSTEM

VERSION 2.0

03:00 PM 10/26/07

TLiIQ System User Manual 2 – 6
Section 2 – Installation

SETTING THE DATE AN D TIME

1. From the Main Menu, select CHANGE SETUP by pressing the ↓ to

get to the second page of the Main Menu. Press 6 for CHANGE
SETUP. This will display the SETUP MENU.

2. From the SETUP MENU, press 1 to display DATE/TIME and follow

the prompts.

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

fFN MAIN MENU

4-ACCESS DATA
5-VIEW SETUP
6-CHANGE SETUP ↑↓

SETUP MENU

1-DATE/TIME

2-AUTOPRINT
3-INCUBATION MODE ↓

TLiIQ System User Manual 2 – 7
Section 2 – Installation

TLi

IQ

QCette® SETUP

1. From the Main Menu, select CHANGE SETUP by pressing the ↓ to

get to the second page of the Main Menu. Press 6 for CHANGE
SETUP. This will display the SETUP MENU.

2. From the SETUP MENU, press the ↓ or 4 to display QCette SETUP

and follow the prompts.

For more details about setting up the TLi

IQ

QCette, see Section 4, Software Functions – Detailed Descriptions.

SETUP MENU

4-QCette SETUP

↑

fFN MAIN MENU

4-ACCESS DATA
5-VIEW SETUP
6-CHANGE SETUP ↑↓

SETUP MENU

1-DATE/TIME

2-AUTOPRINT
3-INCUBATION MODE ↓

TLiIQ System User Manual 2 – 8
Section 2 – Installation

FACTORY DEFAULT SETTINGS

The TLi

IQ

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:
AUTOPRINT

Factory setting is Autoprint ON. After every result, the printer will generate a printed result.
INCUBATION MODE

Factory setting is INTERNAL Mode. The incubation mode refers to the timing of the incubation process and the initiation
of the cassette analysis.

In the INTERNAL mode, the analyzer will time the incubation and automatically start the analysis when the incubation is
complete.
In the EXTERNAL mode, the user will be responsible for timing the incubation and for starting the analysis.

NOTE: The INTERNAL mode is recommended by the manufacturer to ensure proper timing of the assay.

TLiIQ System User Manual 3 − 1

Section 3 – General Operating/Testing Instructions

SECTION 3 – GENERAL OPERATING / TESTING INSTRUCTIONS

After instrument installation, the TLi

IQ

analyzer can be operated on a day-to-day basis by using the following procedures.

Read Section 4 for detailed descriptions of displays, prompts and operating sequences.

STARTING THE SYSTEM

1. Turn on the analyzer using the on/off switch located on the left side

of the analyzer.

The screen will display SYSTEM DIAGNOSTICS. If the analyzer fails
the self-test, two beeps will sound; otherwise the analyzer will go to the
next screen.

Once SYSTEM DIAGNOSTICS is complete, the display will change to
the software VERSION and the DATE and TIME for five seconds and
then to the Main Menu. Verify the date and time are correct.
See Section 4 for setting Date/Time.

2. Turn on the printer using switch at rear and ensure labels

are in the printer. See Section 6 for loading printer labels.

HOLOGIC TLi SYSTEM

VERSION 2.0

SYSTEM DIAGNOSTICS

IN PROCESS

HOLOGIC TLi SYSTEM

VERSION 2.0

03:00 PM 10/26/07

TLiIQ System User Manual 3 − 2

Section 3 – General Operating/Testing Instructions

SET CALIBRATION
NOTE: Calibration must be set when changing cassette lots.

1. From the Main Menu, press 2 to select SET CALIBRATION.

2. Enter USER ID and press ENTER.

3. Enter the CASSETTE LOT# (on cassette pouch) and press ENTER.

The lot number must be entered to proceed to the next step.

fFN MAIN MENU

1-TEST PATIENT

2-SET CALIBRATION

3-DAILY QC ↓

SET CALIBRATION

USER ID

>JOHN SMITH

ENTER-CONFIRM

SET CALIBRATION

CASSETTE LOT#

>L1002

ENTER-ACCEPT

TLiIQ System User Manual 3 − 3

Section 3 – General Operating/Testing Instructions

4. Enter the CALIBRATION CODE# (on cassette box label) and press

ENTER. The code number must be entered to proceed to the next
step.

NOTE: The calibration code is established by Hologic for each lot of

Rapid fFN Cassettes.

5. When calibration is complete, the system will automatically display

and print the result if AUTOPRINT is set to ON, or it may be
printed/reprinted by pressing the PRINT/ENTER key.

6. Press ESC to return to the Main Menu.

FETAL FIBRONECTIN

03:00 PM 10/26/07

SYSTEM CALIBRATED

USER:JOHN SMITH →

SET CALIBRATION

CALIBRATION CODE#

>FG56

ENTER-ACCEPT

TLiIQ System User Manual 3 − 4

Section 3 – General Operating/Testing Instructions

TEST PATIENT (Internal Incubation Mod e)

1. From the Main Menu, press 1 to select TEST PATIENT.

2. Enter USER ID and press ENTER.

3. Enter the last two digits of the CASSETTE LOT# (on cassette

pouch) and press ENTER. The lot number must be entered to
proceed to the next step.

NOTE: The analyzer will automatically compare the CASSETTE LOT#

used to set calibration with the cassette lot number used for
patient testing. If the lot numbers do not match, the analyzer will
request the user to recalibrate the system. The cassette lot
number used for calibration will be displayed on the third line.

fFN MAIN MENU

1-TEST PATIENT

2-SET CALIBRATION
3-DAILY QC ↓

TEST PATIENT

USER ID

>JOHN SMITH

ENTER-CONFIRM

TEST PATIENT

CASSETTE LOT#

>L1002

ENTER-ACCEPT

TLiIQ System User Manual 3 − 5

Section 3 – General Operating/Testing Instructions

4. Enter up to 16 alphanumeric characters for a PATIENT ID and press

ENTER.

5. Insert cassette and press ENTER.

6. Add sample and immediately press ENT ER.

PATIENT ID

>JANE DOE 123

ENTER-ACCEPT

INTERNAL INCUBATION

INSERT CASSETTE

PRESS ENTER

TO CONTINUE

ADD SAMPLE

AND IMMEDIATELY

PRESS ENTER

TLiIQ System User Manual 3 − 6

Section 3 – General Operating/Testing Instructions

7. The analyzer will begin a 20-minute incubation countdown.

8. Following incubation, the analyzer will begin analysis of the cassette.

9. When testing is complete, the system will automatically display and

print the result if AUTOPRINT is set to ON, or it may be
printed/reprinted by pressing the PRINT/ENTER key.

10. Press ESC to return to the Main Menu.

FETAL FIBRONECTIN

03:00 PM 10/26/07
PT:JANE DOE 123
RESULT:POSITIVE →

TEST IN PROCESS

DO NOT REMOVE

CASSETTE

19 MIN 56 SEC

TEST IN PROCESS

ANALYZING

DO NOT REMOVE

CASSETTE

TLiIQ System User Manual 3 − 7

Section 3 – General Operating/Testing Instructions

DAILY QC
NOTE: TLi

IQ

QCette SETUP must be performed PRIOR to running the

QCette as a quality control device. See Section 4 for TLi

IQ

QCette

SETUP.

1. From the Main Menu, press 3 to select DAILY QC.

2. Enter USER ID and press ENTER.

3. Enter the QCette SN (on QCette plastic housing) and press ENTER.
The serial number must be entered to proceed to the next step. The
correct format is 6 numbers (e.g., 001004). Enter all leading zeros.

NOTE: The serial number entered at daily QC must be identical to the
serial number entered at TLi

IQ

QCette setup.

fFN MAIN MENU

1-TEST PATIENT
2-SET CALIBRATION
3-DAILY QC ↓

QCette

ENTER QCette SN

>001004

ENTER-ACCEPT

QCette

USER ID

>JOHN SMITH

ENTER-CONFIRM

TLiIQ System User Manual 3 − 8

Section 3 – General Operating/Testing Instructions

4. Insert the QCette and press ENTER. The analyzer will begin the

analysis of the QCette.

5. When testing is complete, the system will automatically display and
print the result if AUTOPRINT is set to ON, or it may be
printed/reprinted by pressing the PRINT/ENTER key.

6. Press ESC to return to the Main Menu.

INSERT QCette

ENTER-CONTINUE

TEST IN PROCESS

ANALYZING

DO NOT REMOVE

CASSETTE

QCette

03:00 PM 10/26/07

SYSTEM: PASS

USER:JOHN SMITH →

TLiIQ System User Manual 3 − 9

Section 3 – General Operating/Testing Instructions

LIQUID CONTROLS (Internal Incubati on Mod e)

1. From the Main Menu, press 8 to select LIQUID CONTROLS.

2. Enter USER ID and press ENTER.

3. Enter the CASSETTE LOT# (on cassette pouch) and press ENTER.
The lot number must be entered to proceed to the next step.

RUN CONTROL

CASSETTE LOT#

>L1002

ENTER-ACCEPT

fFN MAIN MENU

7-TEST COUNTS

8-LIQUID CONTROLS

↓

RUN CONTROL

USER ID

>JOHN SMITH

ENTER-CONFIRM

TLiIQ System User Manual 3 − 10

Section 3 – General Operating/Testing Instructions

4. Select Negative or Positive Control.

5. Enter the CONTROL LOT# (on bottle label) and press ENTER.

6. Insert cassette and press ENTER.

CONTROL TEST MENU

1-NEGATIVE CONTROL
2-POSITIVE CONTROL

NEGATIVE CTL LOT#

>M1023

ENTER-CONFIRM

INTERNAL INCUBATION

INSERT CASSETTE

PRESS ENTER

TO CONTINUE

TLiIQ System User Manual 3 − 11

Section 3 – General Operating/Testing Instructions

7. Add sample and immediately press ENT ER.

8. The analyzer will begin a 20-minute incubation countdown.

9. Following incubation, the analyzer will begin analysis of the cassette.

10. When testing is complete, the system will automatically display and
print the result if AUTOPRINT is set to ON, or it may be
printed/reprinted by pressing the PRINT/ENTER key.

11. Press ESC to return to the Main Menu.

FETAL FIBRONECTIN

03:00 PM 10/26/07
NEG CTL:M1023
RESULT:PASS →

ADD SAMPLE

AND IMMEDIATELY

PRESS ENTER

TEST IN PROCESS

DO NOT REMOVE

CASSETTE

19 MIN 56 SEC

TEST IN PROCESS

ANALYZING

DO NOT REMOVE

CASSETTE

TLiIQ System User Manual 3 − 12

Section 3 – General Operating/Testing Instructions

VIEWING RESULTS ON SCREEN

Upon completion of every test, the analyzer will automatically display the
results on up to three screens. Each screen can be accessed by using
the ← and → keys. To print the result record, press the ENTER/PRINT
key from any screen.

NOTE: Internal controls are performed automatically during each Rapid

fFN test. These internal controls check for (1) a threshold level of
signal at the procedural control line, (2) proper sample flow
across the Rapid fFN Cassette, (3) absence of conjugate
aggregation, and (4) proper functioning of the TLi

IQ

analyzer

hardware.

FETAL FIBRONECTIN

03:00 PM 10/26/07
PT:JANE DOE 123
RESULT:POSITIVE →

CAL CODE:FG56

CASSETTE LN:L1002
ANALYZER ID:00426
ESC-MAIN MENU ←

INTERNAL CONTROLS

USER:JOHN SMITH
ANALYZER: PAS S
CASSETTE: PASS ← →

TLiIQ System User Manual 3 − 13

Section 3 – General Operating/Testing Instructions

INCUBATION MODE

The incubation mode may be Internal (incubation timed by analyzer) or External (incubation timed by user). The user
prompts are the same for both modes until the analyzer reaches the “INSERT CASSETTE” screen.

NOTE: The INTERNAL mode is recommended by the manufacturer to ensure proper timing of the assay.
INTERNAL MODE – In this mode, pressing ENTER will prompt the user

to add the sample and the analyzer will automatically complete the test.
If the sample is not added within 2 minutes, the test is invalidated.

INTERNAL INCUBATION

INSERT CASSETTE

PRESS ENTER

TO CONTINUE

TEST IN PROCESS

DO NOT REMOVE

CASSETTE

19 MIN 56 SEC

ADD SAMPLE

AND IMMEDIATELY

PRESS ENTER

TLiIQ System User Manual 3 − 14

Section 3 – General Operating/Testing Instructions

EXTERNAL MODE – In this mode, the user is responsible for timing the
incubation and starting the analysis. Upon completion of 20 minute
incubation, insert cassette and press ENTER. The analyzer will
automatically complete the test. If additional cassettes are run, wait at
least 5 minutes before adding sample to the next cassette.

EXTERNAL INCUBATION

WHEN TIME COMPLETE
INSERT CASSETTE
AND PRESS ENTER

TEST IN PROCESS

ANALYZING

DO NOT REMOVE

CASSETTE

TLiIQ System User Manual 4 − 1

Section 4 − Software Functions - Detailed Descriptions

SECTION 4 − SOFTWARE FUNCTIONS - DET AILED DESCRIPTIONS

STARTUP SCREEN

When the analyzer is turned on, the screen will display HOLOGIC TLi
SYSTEM and the software version, while performing an internal self-test
(SYSTEM DIAGNOSTICS).

Following the self-test, the analyzer displays the software version and
the current date and time for five seconds before displaying the Main
Menu.

HOLOGIC TLi SYSTEM

VERSION 2.0

SYSTEM DIAGNOSTICS

IN PROCESS

HOLOGIC TLi SYSTEM

VERSION 2.0

03:00 PM 10/26/07

TLiIQ System User Manual 4 − 2

Section 4 − Software Functions - Detailed Descriptions

MAIN MENU

The Main Menu, displayed over three screens, consists of Test Patient,
Set Calibration, Daily QC, Access Data, View Setup, Change Setup, Test
Counts, and Liquid Controls. Selecting the number in front of each option
initiates that procedure or displays a submenu.

fFN MAIN MENU

1-TEST PATIENT
2-SET CALIBRATION
3-DAILY QC ↓

fFN MAIN MENU

4-ACCESS DATA
5-VIEW SETUP
6-CHANGE SETUP ↑↓

fFN MAIN MENU

7-TEST COUNTS
8-LIQUID CONTROLS
↑

TLiIQ System User Manual 4 − 3

Section 4 − Software Functions - Detailed Descriptions

SET CALIBRATION

Option 2 on the Main Menu screen allows the user to set the calibration
on the analyzer. Follow the analyzer prompts. Calibration must be set
when changing cassette lots.

NOTE: If the calibration has not been set, menu option 2 will flash.
Calibration must be set before the analyzer can be used for testing.

The most recent USER ID is always displayed. Press ENTER to accept
the ID, or enter a new User ID. This field will accept 15 alpha or numeric
characters. To leave this field blank, delete the information using the ←
key.

SET CALIBRATION

USER ID

>JOHN SMITH

ENTER-CONFIRM

fFN MAIN MENU

1-TEST PATIENT

2-SET CALIBRATION

3-DAILY QC ↓

TLiIQ System User Manual 4 − 4

Section 4 − Software Functions - Detailed Descriptions

The CASSETTE LOT# must be entered to proceed to the next step. The
CASSETTE LOT# is located on the cassette pouch. The software
requires that the lot number is entered in the correct format: one alpha
character followed by four numeric characters (e.g., L1002).

The CALIBRATION CODE# must be entered to proceed to the next step.
The CALIBRATION CODE# is located on the cassette box. The software
requires that the code number is entered in the correct format: two alpha
characters followed by two numeric characters (e.g., FG56).

NOTE: The calibration code is established by Hologic for each lot of

Rapid fFN Cassettes.

Calibration Data Record - This record is displayed over two screens.
Each screen can be accessed by using the → and ← keys. The
complete record will be printed automatically if AUTOPRINT is set to ON,
or it may be printed/reprinted by pressing the PRINT/ENTER key.

SET CALIBRATION

CALIBRATION CODE#

>FG56

ENTER-ACCEPT

FETAL FIBRONECTIN

03:00 PM 10/26/07

SYSTEM CALIBRATED

USER:JOHN SMITH →

CAL CODE:FG56

CASSETTE LN:L1002
ANALYZER ID:00426
ESC-MAIN MENU ←

SET CALIBRATION

CASSETTE LOT#

>L1002

ENTER-ACCEPT

TLiIQ System User Manual 4 − 5

Section 4 − Software Functions - Detailed Descriptions

TEST PATIENT (Internal Incubation Mode)
Option 1 on the Main Menu screen allows the user to test a patient
sample. Follow the analyzer prompts.

The most recent USER ID is always displayed. Press ENTER to accept
the ID, or enter a new User ID. This field will accept 15 alpha or numeric
characters. To leave this field blank, delete the information using the ←
key.

The CASSETTE LOT# must be entered to proceed to the next step. For
convenience, the last 2 numbers only can be entered if the lot has not
changed. The CASSETTE LOT# is located on the cassette pouch. The
software requires that the lot number is entered in the correct format: one
alpha character followed by four numeric characters (e.g., L1002).

TEST PATIENT

USER ID

>JOHN SMITH

ENTER-CONFIRM

TEST PATIENT

CASSETTE LOT#

>L1002

ENTER-ACCEPT

fFN MAIN MENU

1-TEST PATIENT

2-SET CALIBRATION
3-DAILY QC ↓

TLiIQ System User Manual 4 − 6

Section 4 − Software Functions - Detailed Descriptions

The analyzer automatically compares the CASSETTE LOT# used to set
calibration with the cassette lot number used for patient testing. If the lot
numbers do not match, the test process cannot continue. When this
occurs, the cassette lot number used for calibration will be displayed,
and the user is prompted to recalibrate the system.

Enter up to 16 alphanumeric characters for a PATIENT ID and press
ENTER.

This message will be displayed if a cassette is present in the analyzer
prior to reaching the next screen. Remove cassette and press ENTER.

PATIENT ID

>JANE DOE 123

ENTER-ACCEPT

CASSETTE LOT CHANGED

CALIBRATE SYSTEM

L1002

ESC-MAIN MENU

REMOVE CASSET TE

PRESS ENTER

TO CONTINUE

TLiIQ System User Manual 4 − 7

Section 4 − Software Functions - Detailed Descriptions

The analyzer then prompts the user to insert cassette and press ENTER.

This message will be displayed if a cassette is not inserted. Press
ENTER to return to the previous screen.

A two-minute timer starts during which time this message flashes and the
analyzer beeps. Add patient sample and immediately press ENTER.

INTERNAL INCUBATION

INSERT CASSETTE

PRESS ENTER

TO CONTINUE

ADD SAMPLE

AND IMMEDIATELY

PRESS ENTER

CASSETT NOT

INSERTED

ENTER-CONTINUE

CASSETTE NOT

INSERTED

ENTER-CONTINUE

TLiIQ System User Manual 4 − 8

Section 4 − Software Functions - Detailed Descriptions

If the patient sample is not added and ENTER not pressed within allotted
time, the test process cannot continue. This message will be displayed.
Press ESC to return to the Main Menu. No record of the test will be held
in memory.

Once the sample is added, the analyzer will begin a 20-minute
incubation countdown. To abort the test, press ESC. Pressing ESC will
terminate the test and the data will be lost.

Upon completion of the incubation period, the analyzer will begin the
analysis of the cassette. Do not disturb the analyzer until the results are
displayed. The analysis will take approximately 2 - 3 minutes.

SAMPLE NOT ADDED

WITHIN ALLOTTED TIME

ESC-MAIN MENU

TEST IN PROCESS

ANALYZING

DO NOT REMOVE

CASSETTE

TEST IN PROCESS

DO NOT REMOVE

CASSETTE

19 MIN 56 SEC

TLiIQ System User Manual 4 − 9

Section 4 − Software Functions - Detailed Descriptions

TEST WARNING: This mes s age will be disp layed if ESC was pressed
during testing. Lines 1 and 2 will flash prompting the user to select
ENTER to continue test, or ESC to end test. This message will hold for 5
seconds and then revert back to its respective screen. If the test is
cancelled, a new cassette will be required to repeat the test.

Patient Data Record – This record is displayed over three screens. Each
screen can be accessed by using the ← and → keys. The complete
record will be printed autom aticall y if AUTOPRINT is set to ON, or it may
be printed/reprinted by pressing the PRINT/ENTER key.

Patient results are POSITIVE, NEGATIVE, or INVALID.
An INVALID result should be repeated. (See Section 7, Item 13.)
Invalid results will not be stored in memory.
NOTE: Internal Controls are performed automatically during each Rapid

fFN test. These internal controls check for (1) a threshold level of
signal at the procedural control line, (2) proper sample flow
across the Rapid fFN Cassette, (3) absence of conjugate
aggregation, and (4) proper functioning of the TLi

IQ

analyzer

hardware.

FETAL FIBRONECTIN

03:00 PM 10/26/07
PT:JANE DOE 123
RESULT:POSITIVE →

INTERNAL CONTROLS

USER:JOHN SMITH
ANALYZER: PAS S
CASSETTE: PASS ← →

ARE YOU SURE YOU

WANT TO CANCEL TEST

ENTER-CONTINUE

ESC-MAIN MENU

CAL CODE:FG56

CASSETTE LN:L1002
ANALYZER ID:00426
ESC-MAIN MENU ←

TLiIQ System User Manual 4 − 10

Section 4 − Software Functions - Detailed Descriptions

DAILY QC

Prior to running the TLi

IQ

QCette® for the first time, QCette SETUP must

be performed. See page 4-29. Refer to the TLi

IQ

QCette directional insert

for more information.
Option 3 on the Main Menu screen allows the user to run the QCette.

The most recent USER ID is always displayed. Press ENTER to accept
the ID, or enter a new User ID. This field will accept 15 alpha or numeric
characters. To leave this field blank, delete the information using the ←
key.

The QCette SN must be entered to proceed to the next step. The serial
number is printed on the QCette plastic housing. The software requires
that the serial number is entered in the correct format: six numeric
characters (e.g., 001004). Enter al l leadin g zeros .

QCette

ENTER QCette SN

>001004

ENTER-CONFIRM

QCette

USER ID

>JOHN SMITH

ENTER-CONFIRM

fFN MAIN MENU

1-TEST PATIENT
2-SET CALIBRATION
3-DAILY QC ↓

TLiIQ System User Manual 4 − 11

Section 4 − Software Functions - Detailed Descriptions

This message will be displayed if the QCette serial number entered is not
identical to the serial number entered at the time of QCette setup.

This message will be displayed if a cassette is present in the analyzer
prior to reaching the next screen. Remove cassette and press ENTER.

The analyzer then prompts the user to insert the QCette and press
ENTER.

This message will be displayed if the QCette is not inserted. Press
ENTER to continue.

INSERT QCette

ENTER-CONTINUE

CASSETTE # CHANGED

NNNNNN

SETUP ANALYZER CTL

ESC-MAIN MENU

CASSETTE NOT

INSERTED

ENTER-CONTINUE

REMOVE CASSET TE

PRESS ENTER

TO CONTINUE

TLiIQ System User Manual 4 − 12

Section 4 − Software Functions - Detailed Descriptions

A two-minute timer starts during which time this message flashes and the
analyzer beeps. Insert the QCette and pres s ENTER.

The analyzer will read the QCette. Do not disturb the analyzer until the
results are displayed. The analysis will take approximately 2-3 minutes.

TEST IN PROCESS

ANALYZING

DO NOT REMOVE

CASSETTE

INSERT QCette

ENTER-CONTINUE

TLiIQ System User Manual 4 − 13

Section 4 − Software Functions - Detailed Descriptions

TEST WARNING: This message will be displa yed if ESC was pres sed
during testing. Lines 1 and 2 will flash prompting the user to select
ENTER to continue test, or ESC to end test. This message will hold for
5 seconds and then revert back to its respective screen.

QCette Data Record – This record will be displayed on two screens.
Each screen can be accessed by using the ← and → keys. The
complete record will be printed automatically if AUTOPRINT is set to ON,
or it may be printed/reprinted by pressing the PRINT/ENTER key.

QCette results are SYSTEM PASS, SYSTEM FAIL, or INVALID.
A FAIL or INVALID result should be repeated. (See Section 7, Items 9

and 10.)
Invalid results will not be stored in memory.

ARE YOU SURE YOU

WANT TO CANCEL TEST

ENTER-CONTINUE

ESC-MAIN MENU

QCette

03:00 PM 10/26/07

SYSTEM: PASS

USER:JOHN SMITH →

CAL CODE:FG56

QCette SN:00104
ANALYZER ID:00426
ESC-MAIN MENU ←

TLiIQ System User Manual 4 − 14

Section 4 − Software Functions - Detailed Descriptions

LIQUID CONTROLS (Internal Incubati on Mod e)
Option 8 on the Main Menu screen allows the user to run the LIQUID
CONTROLS.

The most recent USER ID is always displayed. Press ENTER to accept
the ID, or enter a new User ID. This field will accept 15 alpha or numeric
characters. To leave this field blank, delete the information using the ←
key.

The CASSETTE LOT# must be entered to proceed to the next step. For
convenience, the last 2 numbers only can be entered if the lot has not
changed. The CASSETTE LOT# is located on the cassette pouch. The
software requires that the lot number is entered in the correct format: one
alpha character followed by four numeric characters (e.g., L1002).

RUN CONTROL

USER ID

>JOHN SMITH

ENTER-CONFIRM

fFN MAIN MENU

7-TEST COUNTS

8-LIQUID CONTROLS

↓

RUN CONTROL

CASSETTE LOT#

>L1002

ENTER - ACCEPT

TLiIQ System User Manual 4 − 15

Section 4 − Software Functions - Detailed Descriptions

The analyzer automatically compares the CASSETTE LOT# used to set
calibration with the cassette lot number used for testing controls. If the lot
numbers do not match, the test process cannot continue. When this
occurs, the cassette lot number used for calibration will be displayed,
and the user is prompted to recalibrate the system.

From the CONTROL TEST MENU, select 1-NEGATIVE CONTROL or 2­POSITIVE CONTROL.

The most recent CONTROL LOT# is always displayed. Press ENTER to
accept the lot number, or enter a new control lot number. This field will
accept up to 12 alphanumeric characters.

CONTROL TEST MENU

1-NEGATIVE CONTROL
2-POSITIVE CONTROL

NEGATIVE CTL LOT#

>M1023

ENTER-CONFIRM

CASSETTE LOT CHANGED

CALIBRATE SYSTEM

L1002

ESC-MAIN MENU

TLiIQ System User Manual 4 − 16

Section 4 − Software Functions - Detailed Descriptions

This message will be displayed if a cassette is present in the analyzer
prior to reaching the next screen. Remove cassette and press ENTER.

The analyzer then prompts the user to insert the cassette and press
ENTER.

This message will be displayed if a cassette is not inserted. Press
ENTER to return to the previous screen.

INTERNAL INCUBATION

INSERT CASSETTE

PRESS ENTER

TO CONTINUE

REMOVE CASSET TE

PRESS ENTER

TO CONTINUE

CASSETTE NOT

INSERTED

ENTER-CONTINUE

TLiIQ System User Manual 4 − 17

Section 4 − Software Functions - Detailed Descriptions

A two-minute timer starts during which time this message flashes and the
analyzer beeps. Add control sample and immediately press ENTER.

If the sample is not added and ENTER not pressed within allotted tim e,
the test process cannot continue. This message will be displayed. Press
ESC to return to the Main Menu. No record of the test will be held in
memory.

Once the sample is added, the analyzer will begin a 20-minute
incubation countdown. To abort the test, press ESC. Pressing ESC will
terminate the test and the data will be lost.

Upon completion of the incubation period, the analyzer will begin the
analysis of the cassette. Do not disturb the analyzer until the results are
displayed. The analysis will take approximately 2-3 minutes.

TEST IN PROCESS

DO NOT REMOVE

CASSETTE

19 MIN 56 SEC

TEST IN PROCESS

ANALYZING

DO NOT REMOVE

CASSETTE

ADD SAMPLE

AND IMMEDIATELY

PRESS ENTER

SAMPLE NOT ADDED

WITHIN ALLOTTED TIME

ESC-MAIN MENU

TLiIQ System User Manual 4 − 18

Section 4 − Software Functions - Detailed Descriptions

TEST WARNING: This message will be displa yed if ESC was pres sed
during testing. Lines 1 and 2 will flash prompting the user to select
ENTER to continue test or ESC to end test. This message will hold for 5
seconds and then revert back to its respective screen. If the test is
cancelled, a new cassette will be required to repeat the test.

Liquid Control Data Record - This record is displayed over three screens.
Each screen can be accessed by using the ← and → keys. The
complete record will be printed automatically if AUTOPRINT is set to ON,
or it may be printed/reprinted by pressing the PRINT/ENTER key.

Control results are PASS, FAIL, or INVALID.
A FAIL or INVALID result should be repeated (See Section 7, Items 11

and 12.)
Invalid results will not be stored in memory.

FETAL FIBRONECTIN

03:00 PM 10/26/07
NEG CTL:M1023
RESULT:PASS →

INTERNAL CONTROLS

USER:JOHN SMITH
ANALYZER: PAS S
CASSETTE: PASS ← →

ARE YOU SURE YOU

WANT TO CANCEL TEST

ENTER–CONTINUE

ESC–MAIN MENU

CAL CODE:FG56

CASSETTE LN:L1002
ANALYZER ID:00426
ESC-MAIN MENU ←

TLiIQ System User Manual 4 − 19

Section 4 − Software Functions - Detailed Descriptions

ACC ESS DATA - VIEW/PRINT DATA

Option 4 on the Main Menu screen allows the user to ACCESS DATA
stored in the analyzer.

Select option 1 on the ACCESS DATA MENU for VIEW/PRINT DATA.

Select the category of data records to view/print. The categories are
displayed over two screens. Each screen can be accessed by using ↓
and ↑ keys.

ACCESS DATA MENU

1-VIEW/PRINT DATA

2-DATA TRANSFER

ACCESS DATA MENU

1-PATIENT

2-QCette
3-CONTROLS ↓

fFN MAIN MENU

4-ACCESS DATA

5-VIEW SETUP
6-CHANGE SETUP ↑↓

ACCESS DATA MENU

4-CALIBRATION
↑

TLiIQ System User Manual 4 − 20

Section 4 − Software Functions - Detailed Descriptions

The most recent record for the category of data records selected will be
displayed. PATIENT was chosen for this example. Use the ↑ and ↓ keys
to view other records in the category.

Use the ← and → keys to view pages within a record.

Printing the record – The record displayed may be printed by pressing
the ENTER/PRINT key while in any of the three pages of the record. The
full record will be printed on a single label.

Most Recent Patient

Record N
↓

Most Recent Patient

Record N-1

Earliest Patient Record

↑

Pg 1 of record

→

Pg 2 of record

← →

Pg 3 of record

←

TLiIQ System User Manual 4 − 21

Section 4 − Software Functions - Detailed Descriptions

ACC ESS DATA - DATA TRANSFER

Option 4 on the Main Menu screen allows the user to ACCESS DATA
for data transfer to a computer via an RS232 port.

Select option 2 on the ACCESS DATA MENU for DATA TRANSFER.

Connect the appropriate end of the interface cable to the RS232 port
(labeled DATA) of the analyzer. Connect the other end of the interface
cable to the appropriate port of the laboratory computer.

NOTE: Data transferred to a computer is in ASCII format. Capture and organization of the transferred data is done at the
discretion of the user. Hologic Inc. DOES NOT provide software or technical support relating to the manipulation of data
once it has left the analyzer.

ACCESS DATA MENU

1-VIEW/PRINT DATA

2-DATA TRANSFER

fFN MAIN MENU

4-ACCESS DATA

5-VIEW SETUP
6-CHANGE SETUP ↑↓

TLiIQ System User Manual 4 − 22

Section 4 − Software Functions - Detailed Descriptions

This message will be displayed while the data transfer is in process.

This message will be displayed if a computer is not attached. Press ESC
to return to the ACCESS DATA MENU.

PLEASE WAIT

COMPUTER NOT PRESENT

ESC-MENU

TLiIQ System User Manual 4 − 23

Section 4 − Software Functions - Detailed Descriptions

VIEW SETUP

Option 5 on the Main Menu screen allows the user to view current
settings without editing them.

VIEW SETUP is displayed over two screens. Each screen can be
accessed by using ↓ and ↑ keys.

VIEW SETUP

CAL CODE:FG56
DATE:10/26/07
TIME:03:00 PM ↓

VIEW SETUP

INCUBATION:INTERNAL
AUTOPRINT:ON
↑

fFN MAIN MENU

4-ACCESS DATA

5-VIEW SETUP

6-CHANGE SETUP ↑↓

TLiIQ System User Manual 4 − 24

Section 4 − Software Functions - Detailed Descriptions

CHANGE SETUP – DATE/TIME

Option 6 on the Main Menu screen allows the user to change the
DATE/TIME, Autoprint, or Incubation Mode, or to perform QCette Setup
from the SETUP MENU.

The SETUP MENU is displayed over two screens. Each screen can be
accessed by using ↓ and ↑ keys.

Select option 1 on the SETUP MENU to change the DATE/TIME.

SETUP MENU

1-DATE/TIME
2-AUTOPRINT
3-INCUBATION MODE ↓

SETUP MENU

4- QCette SETUP
↑

fFN MAIN MENU

4-ACCESS DATA
5-VIEW SETUP
6-CHANGE SETUP ↑↓

TLiIQ System User Manual 4 − 25

Section 4 − Software Functions - Detailed Descriptions

Enter the date at the cursor position on the SET DATE display.

Single digit months and days must be preceded by a zero (e.g.,
September 9, 2007 will be entered as 09/09/07). Use the ← key to delete
incorrect entries. Press ENTER to accept.

Select 1 for 12 HOUR (AM/PM) format or 2 for 24 HOUR (Military Time)
format on the SET TIME display.

SET DATE

MM/DD/YY

> / /

ENTER-ACCEPT

SET TIME

1-12 HOUR
2-24 HOUR

SET DATE

MM/DD/YY

>09/09/07

ENTER-ACCEPT

TLiIQ System User Manual 4 − 26

Section 4 − Software Functions - Detailed Descriptions

12 Hour (AM/PM) Format
Enter the time at the cursor position on the TIME display.

Single digit hours or minutes must be preceded by a zero (e.g., 9:09am
must be entered as 09:09AM). Use the ← key to delete incorrect entries.
Use the ↑↓ keys to choose AM/PM. Press ENTER to accept and return
to the SETUP MENU.

24 Hour (Military Time) Format
Enter the time at the cursor position on the TIME display.

Single digit hours or minutes must be preceded by a zero (e.g., 9:09am
must be entered as 09:09). Use the ← key to delete incorrect entries.
Press ENTER to accept and return to the SETUP MENU.

TIME

_ : AM

↑↓ AM/PM

ENTER-ACCEPT

TIME

HH:MM

> :

ENTER-ACCEPT

TIME

09:09AM

↑↓ AM/PM

ENTER-ACCEPT

TIME

HH:MM
>09:09

ENTER-ACCEPT

TLiIQ System User Manual 4 − 27

Section 4 − Software Functions - Detailed Descriptions

CHANGE SETUP – AUTOPRINT

Option 6 on the Main Menu screen allows the user to change the
Date/Time, AUTOPRINT, or Incubation Mode, or to perform QCette
Setup from the SETUP MENU.

Select option 2 on the SETUP MENU to change AUTOPRINT.

Autoprint automatically prints test results when set in the ON position.
When set in the OFF position, printouts may be obtained by pressing the
PRINT/ENTER key.

The current setting will be flashing. Select 1-ON or 2-OFF. Press ENTER
to accept and return to the SETUP MENU.

AUTOPRINT

1-ON

2-OFF

ENTER-ACCEPT

SETUP MENU

1-DATE/TIME

2-AUTOPRINT

3-INCUBATION MODE ↓

fFN MAIN MENU

4-ACCESS DATA
5-VIEW SETUP
6-CHANGE SETUP ↑↓

TLiIQ System User Manual 4 − 28

Section 4 − Software Functions - Detailed Descriptions

CHANGE SETUP – INCUBATION MODE

Option 6 on the Main Menu screen allows the user to change the
Date/Time, Autoprint, or INCUBATION MODE, or to perform QCette
Setup from the SETUP MENU.

Select option 3 on the SETUP MENU to change INCUBATION MODE.

In the Internal Mode, the analyzer times the incubation and starts the
analysis. External Mode requires the user to manually time the
incubation and start the analysis.

The current setting will be flashing. Select 1-INTERNAL or 2­EXTERNAL. Press ENTER to accept and return to the SETUP MENU.

INCUBATION MODE

1-INTERNAL

2-EXTERNAL

ENTER-ACCEPT

SETUP MENU

1-DATE/TIME
2-AUTOPRINT
3-INCUBATION MODE ↓

fFN MAIN MENU

4-ACCESS DATA
5-VIEW SETUP
6-CHANGE SETUP ↑↓

TLiIQ System User Manual 4 − 29

Section 4 − Software Functions - Detailed Descriptions

CHANGE SETUP – TLiIQ QCette® SETUP

Option 6 on the Main Menu screen allows the user to change the
Date/Time, Autoprint, or Incubation Mode, or to perform QCette SETUP
from the SETUP MENU.

The SETUP MENU is displayed over two screens. Each screen can be
accessed by using ↓ and ↑ keys.

The QCette SETUP initializes the QCette for use in evaluating the
performance of the analyzer. During the initialization process, the
performance criteria of the analyzer are established. QCette SETUP
must be performed PRIOR to running the QCette as a quality control
device.

Select option 4 on the SETUP MENU to begin QCette SETUP.

fFN MAIN MENU

4-ACCESS DATA
5-VIEW SETUP
6-CHANGE SETUP ↑↓

SETUP MENU

1-DATE/TIME
2-AUTOPRINT
3-INCUBATION MODE ↓

SETUP MENU

4-QCette SETUP
↑

TLiIQ System User Manual 4 − 30

Section 4 − Software Functions - Detailed Descriptions

The most recent USER ID is always displayed. Press ENTER to accept
the ID, or enter a new User ID. This field will accept 15 alpha or numeric
characters. To leave this field blank, delete the information using the ←
key.

The QCette SN must be entered to proceed to the next step. The serial
number is printed on the QCette plastic housing. The software requires
that the serial number is entered in the correct format: six numeric
characters (e.g., 001004). Enter al l leadin g zeros .

This message will be displayed if a cassette is present in the analyzer
prior to reaching the next screen. Remove cassette and press ENTER.

QCette SETUP

ENTER QCette SN

>001004

ENTER-CONFIRM

QCette SETUP

USER ID

>JOHN SMITH

ENTER-CONFIRM

REMOVE CASSET TE

PRESS ENTER

TO CONTINUE

TLiIQ System User Manual 4 − 31

Section 4 − Software Functions - Detailed Descriptions

The analyzer then prompts the user to insert the QCette and press
ENTER. A two-minute timer starts during which time this message
flashes and the analyzer beeps. Insert the QCette and press ENTER.

This message willI be displayed if the QCette is not inserted. Press
ENTER to continue. Then insert the QCette and press ENTER.

The analyzer will begin initializing the QCette. Do not disturb the
analyzer until the results are displayed. The initialization process will take
approximately 12-15 minutes. Initialization can be terminated by pressing
ESC.

INSERT QCette

ENTER-CONTINUE

INITIALIZING QCette

DO NOT REMOVE

CASSETTE

CASSETTE NOT

INSERTED

ENTER-CONTINUE

TLiIQ System User Manual 4 − 32

Section 4 − Software Functions - Detailed Descriptions

TEST WARNING: This message will appear if ESC was press ed dur ing
testing. Lines 1 and 2 will flash prompting the user to select ENTER to
continue test, or ESC to end test. This message will hold for 5 seconds
and then revert back to its respective screen.

Upon completion of the QCette Setup, this message will be displayed.
SETUP COMPLETE indicates that the performance criteria of the
analyzer have been established.

This message will be displayed if the QCette Setup is not completed.
SETUP ERROR indicates that the performance criteria of the analyzer
have not been established. Please refer to Section 7, Troubleshooting.

ARE YOU SURE YOU

WANT TO CANCEL TEST

ENTER-CONTINUE

ESC-MAIN MENU

QCette

SETUP COMPLETE

ESC-MAIN MENU

QCette

SETUP ERROR

NNNN

ESC-MAIN MENU

TLiIQ System User Manual 4 − 33

Section 4 − Software Functions - Detailed Descriptions

TEST COUNTS

Option 7 on the Main Menu screen allows the user to view the number of
tests by category that wer e per f orm ed on the anal yzer and automatically
print a Test Counts Report (TCR).

TEST COUNTS are displayed over two screens. Each screen can be
accessed by using the ← and → keys.

TEST COUNTS

PATIENT:96
CONTROL:8
QCette:30 ←

FETAL FIBRONECTIN

TEST COUNTS

03:00 PM 10/26/07

ANALYZER:00426 →

fFN MAIN MENU

7-TEST COUNTS

8-LIQUID CONTROLS
↑

TLi

IQ

System User Manual 5 − 1

Section 5 − Care of the Analyzer

SECTION 5 − CARE OF THE ANALYZER

GENERAL CLEANING

Keep the analyzer free of dust. If needed, clean the exterior with a damp cloth and mild detergent.

WARNING: Liquids MUST NOT be allowed to seep into the analyzer. Keep the analyzer dry at all

times.

Liquids leaking into the analyzer may cause damage to the electrical components or possibly electrical shock
to the user.

CAUTION: DO NOT use solvents of any type on any part of the analyzer. Solvents can damage the display and keypad.
CLEANING OF CASSETTE INSERTION SITE

The cassette insertion site can come into contact with biological fluids and should be cleaned regularly.

CAUTION: Use appropriate laboratory procedures for handling biohazardous materials.
CLEANING AGENTS APPROVED FOR USE

Reagents not listed below may cause discoloration to the analyzer case and membrane keypad.

The following cleaning agents may be a p p lied with a cloth or lab wiper only. NEVER apply agents by spray.

• 10% Bleach

• 75% Isopropyl Alcohol

• BacDown (disinfectant)

TLi

IQ

System User Manual 6 – 1

Section 6 – Printer

SECTION 6 – PRINTER

LOADING PRINTER LABELS

1. Open the printer cover for access to the interior of the printer. Remove any packing material.

2. Remove the label spool from the printer.

3. Notice that the label spool has distinct LEFT and RIGHT sides. Refer to the illustration on each piece for correct

assembly. The right side slides in and out and can be removed entirely to load label rolls. The adjustable spool
design holds labels of any width.

TLi

IQ

System User Manual 6 – 2

Section 6 – Printer

4. Remove the RIGHT SIDE of the spool by sliding it off the right end.

5. Remove the tape from the end of a new roll of labels. Cut the lead label in half to create a clean straight edge.

The printer feeds a straight edge much easier than a rough edge.

6. Refer to Figure 1 while following these instructions: Slide the roll of

labels over the spool from right to left as shown in Figure 1(a). Then
reattach the right side of the spool and push it firmly against the label
roll as shown in Figure 1(b). The labels will feed from the bottom of
the roll.

7. Ensure the power cord is connected. Turn on the printer (On/Off

switch is located at the back of the printer ). T he green po wer li ght wil l
flash and the printer motor will run as it looks for labels to feed.

Figure 1

b
a

Figure 1

TLi

IQ

System User Manual 6 – 3

Section 6 – Printer

8. Holding the spool of labels in one hand, use the other hand to feed the free end of the roll into the feed slot on the

inside of the printer, as shown in Figure 2. (If it is easier, rest the labels on the top edge of the printer, freeing both
hands to feed the labels.)

9. Push the end into the slot until a slight resistance is felt. Continue

pushing gently. The label feed motor will feed the end and carry the
labels through the printer and out the exit slot. The printer will stop
feeding automatically at the end of the first label. If the motor stops
running while still in the process of loading labels, press the form feed
button to get it started again. (To protect itself the motor stops running
every few seconds.)

10. Insert the label spool into the printer. The spool will fit into the raised

shoulder slots in the printer.

11. Close the cover and the printer is ready to print labels.

Figure 2

TLi

IQ

System User Manual 6 – 4

Section 6 – Printer

REMOVING AN EM PT Y LABEL ROLL
When the printer is out of labels, the green power light will flash.

1. Leave the printer turned on and open the cover. The last label on the roll may be connected to the corrugated core by
a piece of tape. If it is, use scissors to cut the label between the roll and the label feed slot. Remove the label spool
from the printer.

2. Press the Form Feed button on the printer's front panel to eject the remaining label stock from the printer.

3. Slide off the right side of the spool and remove the corrugated core.

4. Load a new roll of labels (see Loading Printer Labels for instructions).

TLi

IQ

System User Manual 6 – 5

Section 6 – Printer

CLEARING LABEL JAMS

If the labels jam in the printer, follow these steps to remove them.

1. Open the printer cover and use scissors to cut the label between the feed slot and the roll of labels.

2. Press the Form Feed button on the printer's front panel to advance the label through the printer. Reload the labels
(see Loading Printer Labels for instructions).

3. If the label will not come through the form feed slot, remove the label spool from the printer. Pull the jammed label
gently back out of the printer through the feed slot.

TLiIQ System User Manual 7 – 1
Section 7 – Troubleshooting

SECTION 7 − TROUBLESHOOTING

GENERAL INFORMATION

The TLi

IQ

analyzer software is designed for easy troubleshooting. Always heed the beep tones and follow the display
screen prompts to obtain the best performance from your System. The following table lists potential problems, sources of
trouble, and recommended solutions. Call Hologic Inc. Technical Service for any questions related to the performance of
your TLi

IQ

System.

ITEM PROBLEM

SOURCE

SOLUTION

1

Analyzer display

screen is blank.

Analyzer Power Cord

and Adapter

ON/OFF Switch

Ensure analyzer power cord is firmly connected to

analyzer.
Ensure analyzer power adapter is plugged into a

grounded AC electrical outl et.

Ensure analyzer ON/OFF switch is in ON position.

2

Error Code is

displayed when
analyzer is first

turned on.

Analyzer

Turn analyzer off and back on to reinitialize the system.

If the Error Code persists, refer to Error/Invalid Code table.

TLiIQ System User Manual 7 – 2
Section 7 – Troubleshooting

ITEM PROBLEM

SOURCE

SOLUTION

3

Analysis process is

interrupted and/or
unusual characters
appear on display
screen, and the
analyzer does not
respond to keypad

inputs.

Electrostatic Discharge

Turn analyzer off and back on to reinitialize the system.

Proceed with testing.

4

Printer fails to print.

Printer Power Cord

ON/OFF Button
Printer Cable

Printer Labels

Ensure printer power cord is firmly connected to printer.

Ensure printer power cord is plugged into a grounded AC
electrical outlet.

Ensure green light is lit. This indicates printer is on.
Ensure printer cable is connected to the printer and the

analyzer.
Ensure printer is not out of printer labels. To order printer

labels, contact Hologic Inc.

TLiIQ System User Manual 7 – 3
Section 7 – Troubleshooting

ITEM PROBLEM

SOURCE

SOLUTION

5

Printer not on when

test was run.

Printer

Turn printer on. Recall the test result on the analyzer

display screen. Press PRINT/ENTER on the analyzer to

print the result.

6

Printer output in
unusual font.

Printer

Turn analyzer and printer off and back on.

7

Analyzer turned off

after calibration, or
power failure
occurred after

calibration.

Power

The calibration remains in memory. Reset calibration only

if prompted by analyzer.

8

Cassette cannot be
removed.

Analyzer

Turn analyzer off and back on to reinitialize the system.

TLiIQ System User Manual 7 – 4
Section 7 – Troubleshooting

ITEM PROBLEM

SOURCE

SOLUTION

9

TLiIQ QCette failed

to complete setup.

TLiIQ QCette

Analyzer

Ensure QCette is clean and not damaged. Repeat TLiIQ

QCette setup as described in Section 4. If the QCette
setup fails a second time, call technical service.

Turn analyzer off and back on to reinitialize the system.
Repeat TLi

IQ

QCette setup as described in Section 4. If

the QCette setup fails a second time, call technical

service.

10

TLiIQ QCette failed

during daily quality
control.

TLiIQ QCette

Analyzer

Ensure QCette is clean and not damaged. Repeat TLiIQ

QCette daily quality control as described in Section 4. If
the QCette testing fails a second time, call technical
service.

Turn analyzer off and back on to reinitialize the system.
Repeat TLi

IQ

QCette daily quality control as described in

Section 4. If the QCette testing fails a second time, call

technical service.

TLiIQ System User Manual 7 – 5
Section 7 – Troubleshooting

ITEM PROBLEM

SOURCE

SOLUTION

11

Liquid control

failed.

Liquid Control

Review the control procedures and repeat the test.

Verify the control has not expired, and is neither cloudy
nor discolored.

If the control fails a second time, call technical service.

12

Invalid liquid control

test result.

Analyzer Internal

Controls: Analyzer
Fail/Cassette Pass

Analyzer Internal
Controls: Analyzer
Pass/Cassette Fail

Refer to Error/Invalid Code table.

Run TLi

IQ

QCette to verify analyzer is functioning properly.
Do not bump or jar analyzer during the test.
Review the Rapid fFN Cassette Kit directional insert to

ensure the correct procedure was followed.
Examine the cassette. Cassette imperfection may cause

an invalid test result. Rerun control on a fresh cassette.

TLiIQ System User Manual 7 – 6
Section 7 – Troubleshooting

ITEM PROBLEM

SOURCE

SOLUTION

13

Invalid patient test

result.

Analyzer Internal

Controls:
Analyzer Fail/Cassette
Pass

Analyzer Internal
Controls:
Analyzer Pass/Cassette
Fail

Refer to Error/Invalid Code table.

Run TLi

IQ

QCette to verify analyzer is functioning.
Do not bump or jar analyzer during the test.
Review the Rapid fFN Cassette Kit directional insert to

ensure the correct procedure was followed.
Examine the cassette. Viscous patient samples that flow

slowly may require testing by an alternate format such as
the fFN Enzyme Immunoassay.

Examine the cassette. Cassette imperfection may cause
an invalid test result. Rerun patient sample on a fresh

cassette.

14

Computer not

present message

appears.

Data Transfer

Refer to Section 4, pp. 21, 22.

TLiIQ System User Manual 7 – 7
Section 7 – Troubleshooting

ERROR/INVALID CODES

ERROR CODE

DEFINITION

TROUBLE SHOOTING PROCEDURE

720, 721

Possible Motor Problem

Turn analyzer off and back on to
reinitialize the system. If error code

persists, call technical service.

621, 622

Possible Optics Problem

Turn analyzer off and back on to
reinitialize the system. If error code

persists, call technical service.

Other Codes

Call technical service

TLi

IQ

System User Manual 8 – 1

Section 8 – Service and Warranty

SECTION 8 – SERVICE AND WARRANTY

TECHNICAL SERVICE

Analyzer
The TLiIQ analyzer is a self-contained instrument. There are no user-serviceable parts. With proper care and use, the
analyzer should operate reliably with minimal attention. If a problem should occur, refer to Section 7, Troubleshooting.
For analyzer service, call Hologic Technical Service.

Printer
The printer is a self-contained instrument. If a problem should occur, refer to Section 7, Troubleshooting. For printer
service, call Hologic Technical Service.

CONTACT INFORMATION
Hologic Inc.

250 Campus Drive
Marlborough, MA 01752 USA
www.Hologic.com