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Hologic TLi IQ User Manual

Ffn (fetal fibronectin) test for in vitro diagnostic use only.
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   Summary of Contents for Hologic TLi IQ

  • Page 1

    System User Manual...

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    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.

  • Page 3

    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.

  • Page 4

    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...

  • Page 5

    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.

  • Page 6

    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: 1-508-263-2967 Authorized HOLOGIC (UK) LIMITED Representative - Europe UNIT 2, LINK 10 NAPIER WAY CRAWLEY, WEST SUSSEX RH10 9RA...

  • Page 7

    The following symbols are used on this instrument: Warning, refer to Manufactured by accompanying documents. Waste Electrical and Electronic Authorized Representative in Equipment - contact Hologic for the European Community disposal of the instrument. Store between 18°C and 30°C Catalog number For in vitro diagnostic testing...

  • Page 8: Table Of Contents

    TABLE OF CONTENTS Section Page Introduction • Intended Use • General Description • Components of the Analyzer • Keypad • Keypad Functions • Keypad Entries • Cassette Insertion Site 1-11 • Displayed/Printed Results 1-12 • Specifications 1-17 • Cautions and Warnings 1-19 Installation •...

  • Page 9: Section Page

    Section Page • Getting Started • Setting the Date and Time • QCette® Setup • Factory Default Settings General Operating/Testing Instructions • Starting the System • Set Calibration • Test Patient • Daily QC • Liquid Controls • Viewing Results On-Screen 3-12 •...

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    Section Page • Set Calibration • Test Patient • 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 •...

  • Page 11

    Section Page Printer • Loading Printer Labels • Removing an Empty Label Roll • Clearing Label Jams Troubleshooting • General Information • Troubleshooting Table • Error/Invalid Codes Service and Warranty • Technical Service • Contact Information - Technical Service • Replacement Parts •...

  • Page 12: Intended Use

    For In Vitro Diagnostic Use Only To be used by trained laboratory personnel INTENDED USE ® The Hologic TLi System is intended to be used in conjunction with the Rapid fFN Cassette, the Rapid fFN Control Kit, ® and the TLi QCette for the detection of fetal fibronectin in cervicovaginal secretions.

  • Page 13: Components Of The Analyzer

    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 1 – 2 System User Manual Section 1 – Introduction...

  • Page 14: Keypad

    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.

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    (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.

  • Page 16

    (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.

  • Page 17: Keypad Entries

    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). 1 – 6 System User Manual Section 1 – Introduction...

  • Page 18

    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.

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    3 - Press each subsequent number 1, 2, 3. CASSETTE LOT # >C912_ ENTER - ACCEPT 4 - Press ENTER after all entries have been made. CASSETTE LOT # >C9123 ENTER - ACCEPT 1 – 8 System User Manual Section 1 – Introduction...

  • Page 20

    Example - to enter Patient Name ABE 1 - Press 2. Use ↑ or ↓ arrow until A appears on the display screen. PATIENT ID PATIENT ID >2 >A ENTER - ACCEPT ENTER - ACCEPT 2 - Press 2 again. Use ↑ or ↓ arrow until B appears on the display screen.

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    3 - Press 3 to enter the next letter. Use ↑ or ↓ arrow until E appears on the display screen. PATIENT ID PATIENT ID >AB3 >ABE ENTER - ACCEPT ENTER - ACCEPT 4 - Press ENTER after all entries have been made. 1 –...

  • Page 22: Cassette Insertion Site

    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). 1 –...

  • Page 23: Displayed/printed Results

    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 automatically printed. Each printed result requires one printer label.

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    ® Example: Displayed/Printed Results of TLi 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 1 – 13 System User Manual Section 1 – Introduction...

  • Page 25

    Example: Displayed/Printed Results of Negative Control Record Displayed Printed FETAL FIBRONECTIN 02:45 PM 10/26/07 NEG CTL:M1023 → RESULT:PASS INTERNAL CONTROLS USER:XXXXXXXXXXXXXX ANALYZER: PASS ← → CASSETTE: PASS CAL CODE:FG56 CASSETTE LN:L1002 ANALYZER ID:01701 ← ESC-MAIN MENU 1 – 14 System User Manual Section 1 –...

  • Page 26

    Example: Displayed/Printed Results of Patient Record Displayed Printed FETAL FIBRONECTIN 03:02 PM 10/26/07 PT:XXXXXXXXXXXXXXXX → RESULT:POSITIVE USER:XXXXXXXXXXXX INTERNAL CONTROLS ANALYZER: PASS ← → CASSETTE: PASS CAL CODE:BB11 CASSETTE LN:A2222 ANALYZER ID:01701 ← ESC-MAIN MENU 1 – 15 System User Manual Section 1 –...

  • Page 27

    Example: Displayed/Printed Results of Test Counts Record Displayed Printed FETAL FIBRONECTIN TEST COUNTS 03:03 PM 10/26/07 → ANALYZER:01701 PATIENT:4 CONTROL:1 QCette:1 ← 1 – 16 System User Manual Section 1 – Introduction...

  • Page 28: Specifications

    SPECIFICATIONS Power Supply UL 12 VDC listed power supply 50 Calibration Records Memory Capacity 50 QCette Records 50 Control Records 50 Patient Records 4 lines Display 20 characters per line alphanumeric 5 x 8 matrix Supertwist LCD Black characters with gray background 3.5 x 4.5 inches Keypad tactile membrane...

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    Length - 8.9 inches Dimensions Width - 6.9 inches Height - 1.0 to 3.0 inches Weight - 1.2 pounds 18° to 30°C Operating Temperature 64° to 86°F A.C. Supply 120VAC / 60Hz / 16W 220VAC / 50Hz / 16W Input Connector Coaxial power plug with positive center conductor Output Connectors 9 pin male and 9 pin female data connectors...

  • Page 30: Cautions And Warnings

    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.

  • Page 31

    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.

  • Page 32: Installation

    SECTION 2 – INSTALLATION GENERAL This section provides detailed installation instructions for the TLi System. Follow installation steps carefully to insure proper installation and operation. ENVIRONMENTAL FACTORS The TLi 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;...

  • Page 33: Unpacking

    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: •...

  • Page 34

    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: •...

  • Page 35: System Setup

    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 outlet.

  • Page 36: 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.) HOLOGIC TLi SYSTEM The analyzer will perform SYSTEM DIAGNOSTICS (a self-test of the VERSION 2.0...

  • Page 37: Setting The Date And Time

    SETTING THE DATE AND TIME 1. From the Main Menu, select CHANGE SETUP by pressing the ↓ to fFN MAIN MENU get to the second page of the Main Menu. Press 6 for CHANGE 4-ACCESS DATA SETUP. This will display the SETUP MENU. 5-VIEW SETUP ↑↓...

  • Page 38: Tli Iq Qcette® Setup

    ® QCette SETUP 1. From the Main Menu, select CHANGE SETUP by pressing the ↓ to fFN MAIN MENU get to the second page of the Main Menu. Press 6 for CHANGE 4-ACCESS DATA SETUP. This will display the SETUP MENU. 5-VIEW SETUP ↑↓...

  • Page 39: Factory Default Settings

    FACTORY DEFAULT SETTINGS The TLi 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.

  • Page 40: General Operating/testing Instructions

    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. HOLOGIC TLi SYSTEM VERSION 2.0 The screen will display SYSTEM DIAGNOSTICS. If the analyzer fails SYSTEM DIAGNOSTICS the self-test, two beeps will sound;...

  • Page 41: Set Calibration

    SET CALIBRATION NOTE: Calibration must be set when changing cassette lots. 1. From the Main Menu, press 2 to select SET CALIBRATION. fFN MAIN MENU 1-TEST PATIENT 2-SET CALIBRATION ↓ 3-DAILY QC Enter USER ID and press ENTER. SET CALIBRATION USER ID >JOHN SMITH ENTER-CONFIRM...

  • Page 42

    CALIBRATION CODE# step. >FG56 ENTER-ACCEPT 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 FETAL FIBRONECTIN and print the result if AUTOPRINT is set to ON, or it may be...

  • Page 43: Test Patient

    TEST PATIENT (Internal Incubation Mode) fFN MAIN MENU 1. From the Main Menu, press 1 to select TEST PATIENT. 1-TEST PATIENT 2-SET CALIBRATION ↓ 3-DAILY QC Enter USER ID and press ENTER. TEST PATIENT USER ID >JOHN SMITH ENTER-CONFIRM 3. Enter the last two digits of the CASSETTE LOT# (on cassette TEST PATIENT pouch) and press ENTER.

  • Page 44

    4. Enter up to 16 alphanumeric characters for a PATIENT ID and press PATIENT ID ENTER. >JANE DOE 123 ENTER-ACCEPT INTERNAL INCUBATION 5. Insert cassette and press ENTER. INSERT CASSETTE PRESS ENTER TO CONTINUE ADD SAMPLE 6. Add sample and immediately press ENTER. AND IMMEDIATELY PRESS ENTER 3 −...

  • Page 45

    The analyzer will begin a 20-minute incubation countdown. TEST IN PROCESS DO NOT REMOVE CASSETTE 19 MIN 56 SEC 8. Following incubation, the analyzer will begin analysis of the cassette. TEST IN PROCESS ANALYZING DO NOT REMOVE CASSETTE 9. When testing is complete, the system will automatically display and FETAL FIBRONECTIN print the result if AUTOPRINT is set to ON, or it may be 03:00 PM...

  • Page 46: Daily Qc

    DAILY QC NOTE: TLi QCette SETUP must be performed PRIOR to running the QCette as a quality control device. See Section 4 for TLi QCette SETUP. fFN MAIN MENU 1-TEST PATIENT 1. From the Main Menu, press 3 to select DAILY QC. 2-SET CALIBRATION ↓...

  • Page 47

    Insert the QCette and press ENTER. The analyzer will begin the analysis of the QCette. INSERT QCette ENTER-CONTINUE TEST IN PROCESS ANALYZING DO NOT REMOVE CASSETTE 5. When testing is complete, the system will automatically display and QCette print the result if AUTOPRINT is set to ON, or it may be 03:00 PM 10/26/07 printed/reprinted by pressing the PRINT/ENTER key.

  • Page 48: Liquid Controls

    LIQUID CONTROLS (Internal Incubation Mode) 1. From the Main Menu, press 8 to select LIQUID CONTROLS. fFN MAIN MENU 7-TEST COUNTS 8-LIQUID CONTROLS ↓ 2. Enter USER ID and press ENTER. RUN CONTROL USER ID >JOHN SMITH ENTER-CONFIRM RUN CONTROL 3.

  • Page 49

    4. Select Negative or Positive Control. CONTROL TEST MENU 1-NEGATIVE CONTROL 2-POSITIVE CONTROL 5. Enter the CONTROL LOT# (on bottle label) and press ENTER. NEGATIVE CTL LOT# >M1023 ENTER-CONFIRM 6. Insert cassette and press ENTER. INTERNAL INCUBATION INSERT CASSETTE PRESS ENTER TO CONTINUE 3 −...

  • Page 50

    ADD SAMPLE 7. Add sample and immediately press ENTER. AND IMMEDIATELY PRESS ENTER 8. The analyzer will begin a 20-minute incubation countdown. TEST IN PROCESS DO NOT REMOVE CASSETTE 19 MIN 56 SEC 9. Following incubation, the analyzer will begin analysis of the cassette. TEST IN PROCESS ANALYZING DO NOT REMOVE...

  • Page 51: Viewing Results On-screen

    VIEWING RESULTS ON SCREEN Upon completion of every test, the analyzer will automatically display the FETAL FIBRONECTIN results on up to three screens. Each screen can be accessed by using 03:00 PM 10/26/07 the ← and → keys. To print the result record, press the ENTER/PRINT PT:JANE DOE 123 →...

  • Page 52: Incubation Mode

    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 –...

  • Page 53: External Mode

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

  • Page 54: Software Functions - Detailed Descriptions

    SECTION 4 − SOFTWARE FUNCTIONS - DETAILED DESCRIPTIONS STARTUP SCREEN When the analyzer is turned on, the screen will display HOLOGIC TLi HOLOGIC TLi SYSTEM SYSTEM and the software version, while performing an internal self-test VERSION 2.0 (SYSTEM DIAGNOSTICS). SYSTEM DIAGNOSTICS...

  • Page 55: Main Menu

    MAIN MENU The Main Menu, displayed over three screens, consists of Test Patient, fFN MAIN MENU Set Calibration, Daily QC, Access Data, View Setup, Change Setup, Test 1-TEST PATIENT Counts, and Liquid Controls. Selecting the number in front of each option 2-SET CALIBRATION initiates that procedure or displays a submenu.

  • Page 56: Set Calibration

    SET CALIBRATION Option 2 on the Main Menu screen allows the user to set the calibration fFN MAIN MENU on the analyzer. Follow the analyzer prompts. Calibration must be set 1-TEST PATIENT when changing cassette lots. 2-SET CALIBRATION ↓ 3-DAILY QC NOTE: If the calibration has not been set, menu option 2 will flash.

  • Page 57

    >FG56 ENTER-ACCEPT characters followed by two numeric characters (e.g., FG56). NOTE: The calibration code is established by Hologic for each lot of Rapid fFN Cassettes. FETAL FIBRONECTIN 03:00 PM 10/26/07 Calibration Data Record - This record is displayed over two screens.

  • Page 58: Test Patient

    TEST PATIENT (Internal Incubation Mode) Option 1 on the Main Menu screen allows the user to test a patient fFN MAIN MENU sample. Follow the analyzer prompts. 1-TEST PATIENT 2-SET CALIBRATION ↓ 3-DAILY QC The most recent USER ID is always displayed. Press ENTER to accept TEST PATIENT the ID, or enter a new User ID.

  • Page 59

    The analyzer automatically compares the CASSETTE LOT# used to set CASSETTE LOT CHANGED calibration with the cassette lot number used for patient testing. If the lot CALIBRATE SYSTEM numbers do not match, the test process cannot continue. When this L1002 occurs, the cassette lot number used for calibration will be displayed, ESC-MAIN MENU and the user is prompted to recalibrate the system.

  • Page 60

    The analyzer then prompts the user to insert cassette and press ENTER. INTERNAL INCUBATION INSERT CASSETTE PRESS ENTER TO CONTINUE This message will be displayed if a cassette is not inserted. Press CASSETTE NOT CASSETT NOT ENTER to return to the previous screen. INSERTED INSERTED ENTER-CONTINUE...

  • Page 61

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

  • Page 62

    TEST WARNING: This message will be displayed if ESC was pressed ARE YOU SURE YOU during testing. Lines 1 and 2 will flash prompting the user to select WANT TO CANCEL TEST ENTER to continue test, or ESC to end test. This message will hold for 5 ENTER-CONTINUE seconds and then revert back to its respective screen.

  • Page 63: Daily Qc

    DAILY QC ® Prior to running the TLi QCette for the first time, QCette SETUP must be performed. See page 4-29. Refer to the TLi QCette directional insert for more information. Option 3 on the Main Menu screen allows the user to run the QCette. fFN MAIN MENU 1-TEST PATIENT 2-SET CALIBRATION...

  • Page 64

    This message will be displayed if the QCette serial number entered is not CASSETTE # CHANGED identical to the serial number entered at the time of QCette setup. NNNNNN SETUP ANALYZER CTL ESC-MAIN MENU This message will be displayed if a cassette is present in the analyzer prior to reaching the next screen.

  • Page 65

    A two-minute timer starts during which time this message flashes and the analyzer beeps. Insert the QCette and press ENTER. INSERT QCette ENTER-CONTINUE The analyzer will read the QCette. Do not disturb the analyzer until the TEST IN PROCESS results are displayed. The analysis will take approximately 2-3 minutes. ANALYZING DO NOT REMOVE CASSETTE...

  • Page 66

    TEST WARNING: This message will be displayed if ESC was pressed ARE YOU SURE YOU during testing. Lines 1 and 2 will flash prompting the user to select WANT TO CANCEL TEST ENTER to continue test, or ESC to end test. This message will hold for ENTER-CONTINUE 5 seconds and then revert back to its respective screen.

  • Page 67: Liquid Controls

    LIQUID CONTROLS (Internal Incubation Mode) Option 8 on the Main Menu screen allows the user to run the LIQUID fFN MAIN MENU CONTROLS. 7-TEST COUNTS 8-LIQUID CONTROLS ↓ The most recent USER ID is always displayed. Press ENTER to accept RUN CONTROL the ID, or enter a new User ID.

  • Page 68

    The analyzer automatically compares the CASSETTE LOT# used to set CASSETTE LOT CHANGED calibration with the cassette lot number used for testing controls. If the lot CALIBRATE SYSTEM numbers do not match, the test process cannot continue. When this L1002 occurs, the cassette lot number used for calibration will be displayed, ESC-MAIN MENU and the user is prompted to recalibrate the system.

  • Page 69

    This message will be displayed if a cassette is present in the analyzer REMOVE CASSETTE prior to reaching the next screen. Remove cassette and press ENTER. PRESS ENTER TO CONTINUE The analyzer then prompts the user to insert the cassette and press INTERNAL INCUBATION ENTER.

  • Page 70

    ADD SAMPLE A two-minute timer starts during which time this message flashes and the AND IMMEDIATELY analyzer beeps. Add control sample and immediately press ENTER. PRESS ENTER If the sample is not added and ENTER not pressed within allotted time, SAMPLE NOT ADDED the test process cannot continue.

  • Page 71

    TEST WARNING: This message will be displayed if ESC was pressed ARE YOU SURE YOU during testing. Lines 1 and 2 will flash prompting the user to select WANT TO CANCEL TEST ENTER to continue test or ESC to end test. This message will hold for 5 ENTER–CONTINUE seconds and then revert back to its respective screen.

  • Page 72: Access Data

    ACCESS DATA - VIEW/PRINT DATA Option 4 on the Main Menu screen allows the user to ACCESS DATA fFN MAIN MENU stored in the analyzer. 4-ACCESS DATA 5-VIEW SETUP ↑↓ 6-CHANGE SETUP Select option 1 on the ACCESS DATA MENU for VIEW/PRINT DATA. ACCESS DATA MENU 1-VIEW/PRINT DATA 2-DATA TRANSFER...

  • Page 73

    Most Recent Patient Record N 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. Most Recent Patient Record N-1 ↑↓...

  • Page 74: Data Transfer

    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.

  • Page 75

    This message will be displayed while the data transfer is in process. PLEASE WAIT This message will be displayed if a computer is not attached. Press ESC COMPUTER NOT PRESENT to return to the ACCESS DATA MENU. ESC-MENU 4 − 22 System User Manual Section 4 −...

  • Page 76: View Setup

    VIEW SETUP Option 5 on the Main Menu screen allows the user to view current fFN MAIN MENU settings without editing them. 4-ACCESS DATA 5-VIEW SETUP ↑↓ 6-CHANGE SETUP VIEW SETUP is displayed over two screens. Each screen can be VIEW SETUP accessed by using ↓...

  • Page 77: Change Setup

    CHANGE SETUP – DATE/TIME Option 6 on the Main Menu screen allows the user to change the fFN MAIN MENU DATE/TIME, Autoprint, or Incubation Mode, or to perform QCette Setup 4-ACCESS DATA from the SETUP MENU. 5-VIEW SETUP ↑↓ 6-CHANGE SETUP The SETUP MENU is displayed over two screens.

  • Page 78

    Enter the date at the cursor position on the SET DATE display. SET DATE MM/DD/YY > ENTER-ACCEPT Single digit months and days must be preceded by a zero (e.g., SET DATE September 9, 2007 will be entered as 09/09/07). Use the ← key to delete MM/DD/YY incorrect entries.

  • Page 79

    TIME 12 Hour (AM/PM) Format Enter the time at the cursor position on the TIME display. ↑↓ AM/PM ENTER-ACCEPT Single digit hours or minutes must be preceded by a zero (e.g., 9:09am TIME must be entered as 09:09AM). Use the ← key to delete incorrect entries. 09:09AM Use the ↑↓...

  • Page 80: Autoprint

    CHANGE SETUP – AUTOPRINT Option 6 on the Main Menu screen allows the user to change the fFN MAIN MENU Date/Time, AUTOPRINT, or Incubation Mode, or to perform QCette 4-ACCESS DATA Setup from the SETUP MENU. 5-VIEW SETUP ↑↓ 6-CHANGE SETUP Select option 2 on the SETUP MENU to change AUTOPRINT.

  • Page 81: Incubation Mode

    CHANGE SETUP – INCUBATION MODE Option 6 on the Main Menu screen allows the user to change the fFN MAIN MENU Date/Time, Autoprint, or INCUBATION MODE, or to perform QCette 4-ACCESS DATA Setup from the SETUP MENU. 5-VIEW SETUP ↑↓ 6-CHANGE SETUP SETUP MENU Select option 3 on the SETUP MENU to change INCUBATION MODE.

  • Page 82

    ® CHANGE SETUP – TLi QCette SETUP Option 6 on the Main Menu screen allows the user to change the fFN MAIN MENU Date/Time, Autoprint, or Incubation Mode, or to perform QCette SETUP 4-ACCESS DATA from the SETUP MENU. 5-VIEW SETUP ↑↓...

  • Page 83

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

  • Page 84

    The analyzer then prompts the user to insert the QCette and press ENTER. A two-minute timer starts during which time this message INSERT QCette flashes and the analyzer beeps. Insert the QCette and press ENTER. ENTER-CONTINUE This message willI be displayed if the QCette is not inserted. Press CASSETTE NOT ENTER to continue.

  • Page 85

    TEST WARNING: This message will appear if ESC was pressed during ARE YOU SURE YOU testing. Lines 1 and 2 will flash prompting the user to select ENTER to WANT TO CANCEL TEST continue test, or ESC to end test. This message will hold for 5 seconds ENTER-CONTINUE and then revert back to its respective screen.

  • Page 86: Test Counts

    TEST COUNTS Option 7 on the Main Menu screen allows the user to view the number of fFN MAIN MENU tests by category that were performed on the analyzer and automatically 7-TEST COUNTS print a Test Counts Report (TCR). 8-LIQUID CONTROLS ↑...

  • Page 87: General Cleaning

    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.

  • Page 88: Loading Printer Labels

    SECTION 6 – PRINTER LOADING PRINTER LABELS Open the printer cover for access to the interior of the printer. Remove any packing material. Remove the label spool from the printer. Notice that the label spool has distinct LEFT and RIGHT sides. Refer to the illustration on each piece for correct assembly.

  • Page 89

    Remove the RIGHT SIDE of the spool by sliding it off the right end. 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. Figure 1 Figure 1 Refer to Figure 1 while following these instructions: Slide the roll of...

  • Page 90

    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.) Figure 2 Push the end into the slot until a slight resistance is felt.

  • Page 91: Removing An Empty Label Roll

    REMOVING AN EMPTY 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.

  • Page 92: Clearing Label Jams

    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).

  • Page 93: General Information

    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 System.

  • Page 94

    Printer Cable Ensure printer cable is connected to the printer and the analyzer. Printer Labels Ensure printer is not out of printer labels. To order printer labels, contact Hologic Inc. 7 – 2 System User Manual Section 7 – Troubleshooting...

  • Page 95

    ITEM PROBLEM SOURCE SOLUTION Printer not on when Printer Turn printer on. Recall the test result on the analyzer test was run. display screen. Press PRINT/ENTER on the analyzer to print the result. Printer output in Printer Turn analyzer and printer off and back on. unusual font.

  • Page 96

    ITEM PROBLEM SOURCE SOLUTION QCette failed QCette Ensure QCette is clean and not damaged. Repeat TLi to complete setup. QCette setup as described in Section 4. If the QCette setup fails a second time, call technical service. Analyzer Turn analyzer off and back on to reinitialize the system. Repeat TLi QCette setup as described in Section 4.

  • Page 97

    ITEM PROBLEM SOURCE SOLUTION Liquid control Liquid Control Review the control procedures and repeat the test. failed. Verify the control has not expired, and is neither cloudy nor discolored. If the control fails a second time, call technical service. Invalid liquid control Analyzer Internal Refer to Error/Invalid Code table.

  • Page 98

    ITEM PROBLEM SOURCE SOLUTION Invalid patient test Analyzer Internal Refer to Error/Invalid Code table. result. Controls: Analyzer Fail/Cassette Run TLi QCette to verify analyzer is functioning. Pass Do not bump or jar analyzer during the test. Analyzer Internal Review the Rapid fFN Cassette Kit directional insert to Controls: ensure the correct procedure was followed.

  • Page 99: Error/invalid Codes

    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.

  • Page 100

    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.

  • Page 101: Technical Service

    TECHNICAL SERVICE (USA/Canada) Tel: 1-888-PRETERM (1-888-773-8376) 1-800-442-9892 Fax: 1-508-263-2967 TECHNICAL SERVICE (Outside the USA and Canada) Tel: Asia +852 3526 0718 Netherlands: 0800 022 6782 Australia: +61 2 9888 8000 Norway: 800 155 64 Austria: 0800 291 919 Portugal: 800 841 034 Belgium: 0800 773 78 Spain:...

  • Page 102: Replacement Parts

    Replacement Parts Item Catalog Number Analyzer Power Adapter 00989 Printer Power Cord 01206 Printer Serial Cable 01087 Printer Labels 01088 ® QCette 01175 User Manual 01207 Contact fFN Customer Service to order replacement parts. 8 – 3 System User Manual Section 8 –...

  • Page 103: Warranty

    CONTACT INFORMATION fFN CUSTOMER SERVICE (USA/Canada) Tel: 1-888-PRETERM (1-888-773-8376) 1-800-442-9892 Fax: 1-508-229-2860 fFN CUSTOMER SERVICE (Outside the USA and Canada) Tel: Asia +852 3526 0718 Netherlands: 0800 022 6782 Australia: +61 2 9888 8000 Norway: 800 155 64 Austria: 0800 291 919 Portugal: 800 841 034 Belgium:...

  • Page 104

    Hologic Inc. warrants to the original purchaser that this system will be free from defects in materials and workmanship for a period of one (1) year from shipment date (except as noted below). During the stated one-year period, Hologic Inc. shall, at its option, replace with a new unit, reconditioned unit, or repair at no charge a unit that is found to be defective.

  • Page 105

    2. Hologic Inc. reserves the right to make changes in the design of this system without obligation to incorporate such changes into previously manufactured systems. Disclaimer of Warranties THIS WARRANTY IS EXPRESSLY MADE IN LIEU OF ANY AND ALL OTHER WARRANTIES EXPRESS OR IMPLIED...

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