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TLi

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

Содержание TLi IQ

Страница 1: ...User Manual System...

Страница 2: ...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...

Страница 3: ...rantee 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...

Страница 4: ...lectrical 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 EN...

Страница 5: ...ou 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...

Страница 6: ...NC 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 Representative Europe HOLOGIC UK LIMITED UNIT 2 LINK 10 NAPIER...

Страница 7: ...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 Europ...

Страница 8: ...se 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 Caution...

Страница 9: ...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 Inc...

Страница 10: ...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 TLiIQ QCette Setup 4 29 Test Counts 4 33 5 C...

Страница 11: ...n 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 Informat...

Страница 12: ...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 calibr...

Страница 13: ...ser 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 insertio...

Страница 14: ...om 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 da...

Страница 15: ...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 re...

Страница 16: ...ny 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 scree...

Страница 17: ...ion 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 charact...

Страница 18: ...23 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...

Страница 19: ...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...

Страница 20: ...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 A...

Страница 21: ...ual 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...

Страница 22: ...TTE 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...

Страница 23: ...sult With AUTOPRINT ON the test result is automatically printed Each printed result requires one printer label Results can be printed from any data record screen either immediately after a test or in...

Страница 24: ...anual 1 13 Section 1 Introduction Example Displayed Printed Results of TLiIQ QCette Displayed Printed QCette 02 40 PM 10 26 07 SYSTEM PASS USER XXXXXXXXXXXX CAL CODE FG56 QCette SN 004640 ANALYZER ID...

Страница 25: ...isplayed Printed Results of Negative Control Record Displayed Printed CAL CODE FG56 CASSETTE LN L1002 ANALYZER ID 01701 ESC MAIN MENU INTERNAL CONTROLS USER XXXXXXXXXXXXXX ANALYZER PASS CASSETTE PASS...

Страница 26: ...Displayed Printed Results 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 FIBR...

Страница 27: ...tem User Manual 1 16 Section 1 Introduction Example Displayed Printed Results of Test Counts Record Displayed Printed PATIENT 4 CONTROL 1 QCette 1 FETAL FIBRONECTIN TEST COUNTS 03 03 PM 10 26 07 ANALY...

Страница 28: ...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...

Страница 29: ...s 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...

Страница 30: ...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 su...

Страница 31: ...he 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 blea...

Страница 32: ...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 wi...

Страница 33: ...ect 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 access...

Страница 34: ...rinter 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 Prin...

Страница 35: ...yzer 3 Connect the small connector of the analyzer power adapter to the analyzer and the larger power connector to a grounded AC electrical outlet Caution Only power connectors provided with the TLiIQ...

Страница 36: ...mponents 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...

Страница 37: ...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 se...

Страница 38: ...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 TLiIQ QCette see Section 4...

Страница 39: ...sult 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 a...

Страница 40: ...de 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 comp...

Страница 41: ...om 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...

Страница 42: ...libration 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 m...

Страница 43: ...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...

Страница 44: ...nter up to 16 alphanumeric characters for a PATIENT ID and press ENTER 5 Insert cassette and press ENTER 6 Add sample and immediately press ENTER PATIENT ID JANE DOE 123 ENTER ACCEPT INTERNAL INCUBATI...

Страница 45: ...he 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...

Страница 46: ...ter 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 Ent...

Страница 47: ...he 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...

Страница 48: ...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 C...

Страница 49: ...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...

Страница 50: ...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...

Страница 51: ...ny 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 f...

Страница 52: ...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 a...

Страница 53: ...tarting 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 b...

Страница 54: ...e 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 c...

Страница 55: ...atient 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...

Страница 56: ...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 ac...

Страница 57: ...e 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 Calib...

Страница 58: ...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 lo...

Страница 59: ...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 ENT...

Страница 60: ...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 pr...

Страница 61: ...le 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...

Страница 62: ...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 no...

Страница 63: ...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...

Страница 64: ...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 mes...

Страница 65: ...g which time this message flashes and the analyzer beeps Insert the QCette and press ENTER The analyzer will read the QCette Do not disturb the analyzer until the results are displayed The analysis wi...

Страница 66: ...l 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 t...

Страница 67: ...racters 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 ha...

Страница 68: ...te 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 2 POSITIVE CONTROL The most recent CONTR...

Страница 69: ...ng 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...

Страница 70: ...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...

Страница 71: ...s 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...

Страница 72: ...yzer 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 an...

Страница 73: ...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 t...

Страница 74: ...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 for...

Страница 75: ...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 DAT...

Страница 76: ...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...

Страница 77: ...ATE 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 S...

Страница 78: ...it 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...

Страница 79: ...orrect 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...

Страница 80: ...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 ENT...

Страница 81: ...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 analys...

Страница 82: ...ach 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...

Страница 83: ...st 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 character...

Страница 84: ...ess 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 th...

Страница 85: ...ective 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 displ...

Страница 86: ...mber of tests by category that were performed on the analyzer and automatically print a Test Counts Report TCR TEST COUNTS are displayed over two screens Each screen can be accessed by using the and k...

Страница 87: ...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 contac...

Страница 88: ...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 a...

Страница 89: ...igure 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 la...

Страница 90: ...s 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...

Страница 91: ...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 butto...

Страница 92: ...e 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...

Страница 93: ...ologic Inc Technical Service for any questions related to the performance of your TLiIQ System ITEM PROBLEM SOURCE SOLUTION 1 Analyzer display screen is blank Analyzer Power Cord and Adapter ON OFF Sw...

Страница 94: ...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 p...

Страница 95: ...ss 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...

Страница 96: ...em Repeat TLiIQ 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 Q...

Страница 97: ...vice 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 TLiIQ QCe...

Страница 98: ...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 sample...

Страница 99: ...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 ba...

Страница 100: ...e 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...

Страница 101: ...tralia 61 2 9888 8000 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...

Страница 102: ...and Warranty Replacement Parts Item Catalog Number Analyzer Power Adapter 00989 Printer Power Cord 01206 Printer Serial Cable 01087 Printer Labels 01088 TLiIQ QCette 01175 User Manual 01207 Contact f...

Страница 103: ...26 0718 Australia 61 2 9888 8000 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 N...

Страница 104: ...or repair at no charge a unit that is found to be defective This warranty is subject to the following exceptions and limitations 1 This warranty is limited to repair or replacement due to defects in...

Страница 105: ...W INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR USE WHICH ARE EXPRESSLY EXCLUDED AND IS THE ONLY WARRANTY GIVEN BY HOLOGIC INC Limitations of Liability IN NO EVENT SHALL HOLOGIC INC BE L...

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