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User Manual - fFN (Fetal Fibronectin) Test

1. TLiig System User Manual Section 7 Troubleshooting ITEM PROBLEM SOURCE SOLUTION 5 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 6 Printer output in Printer Turn analyzer and printer off and back on unusual font 7 Analyzer turned off Power The calibration remains in memory Reset calibration only after calibration or if prompted by analyzer power failure occurred after calibration 8 Cassette cannot be Analyzer Turn analyzer off and back on to reinitialize the system removed TLiig System User Manual Section 7 Troubleshooting ITEM PROBLEM SOURCE SOLUTION 9 TLijq QCette failed TLijq QCette Ensure QCette is clean and not damaged Repeat TLiiq 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 TLijq QCette setup as described in Section 4 If the QCette setup fails a second time call technical service 10 TLijg QCette failed TLijg QCette Ensure QCette is clean and not damaged Repeat TLijq during daily quality QCette daily quality control as described in Section 4 If control the QCette testing fails a second time call technical service Analyzer Turn analyzer off and back on to reinitialize the s
2. 2 Turn on the printer using switch at rear and ensure labels are in the printer See Section 6 for loading printer labels TLiiqg System User Manual 3 1 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 TLiig System User Manual Section 3 General Operating Testing Instructions fFN MAIN MENU 1 TEST PATIENT 2 SET CALIBRATION 3 DAILY QC SET CALIBRATION USER ID gt JOHN SMITH ENTER CONFIRM SET CALIBRATION CASSETTE LOT gt L1002 ENTER ACCEPT 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 Adeza 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 TLiig System User Manual Section 3 General Operating Testing Instructions SET CALIBRATION CALIBRATION CODE gt FG56 ENTER ACCEPT FETAL FIBRONECTIN 08 00 AM 08 21 01 SYSTEM CALIBRATED USER JOHN SMITH gt TEST PA
3. Analyzer Pass Cassette Fail 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 Data Transfer Refer to Section 4 pp 21 22 present message appears TLiig System User Manual 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 TLiig System User Manual Section 7 Troubleshooting SECTION 8 SERVICE AND WARRANTY TECHNICAL SERVICE Analyzer The TLijg 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 Adeza Biomedical Technical Service Printer The printer is a self contained instrument If a problem should occur refer to Section 7 Troubleshooting For printer service call Adeza Biomedical Technical S
4. ACCEPT TLiio System User Manual 1 7 Section 1 Introduction 3 Press each subsequent number 1 2 3 CASSETTE LOT gt C912_ ENTER ACCEPT 4 Press ENTER after all entries have been made CASSETTE LOT gt C9123 ENTER ACCEPT TLiig System User Manual Section 1 Introduction Example to enter Patient Name ABE 1 Press 2 Use 7 or 4 arrow until A appears on the display screen PATIENT ID PATIENT ID ENTER ACCEPT ENTER ACCEPT 2 Press 2 again Use or 4 arrow until B appears on the display screen PATIENT ID PATIENT ID gt A2 gt AB ENTER ACCEPT ENTER ACCEPT TLiig System User Manual Section 1 Introduction 3 Press 3 to enter the next letter Use or J arrow until E appears on the display screen PATIENT ID PATIENT ID gt AB3 gt ABE ENTER ACCEPT ENTER ACCEPT 4 Press ENTER after all entries have been made TLiiqg System User Manual 1 10 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 TLiig System User Manual 1 11 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 assoc
5. 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions SET DATE MM DD YY 2 M i ENTER ACCEPT SET DATE MM DD YY gt 09 09 01 ENTER ACCEPT SET TIME 1 12 HOUR 2 24 HOUR 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 lt key to delete incorrect entries Use the TY 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 lt key to delete incorrect entries Press ENTER to accept and return to the SETUP MENU TLijg System User Manual Section 4 Software Functions Detailed Descriptions _ AM N AM PM ENTER ACCEPT 09 09AM T4 AM PM ENTER ACCEPT TIME HH MM ae ee ENTER ACCEPT TIME HH MM gt 09 09 ENTER ACCEPT 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 te
6. 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 between the equipment 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 TLiiqg System User Manual iii CE Notice This equipment has been tested and found to be in compliance with the following standards per the Low Voltage and EMC 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 UL Compliant This equipment has been tested and fo
7. 00a DATE 08 21 01 NEG CONTROL M1023 USER JOHN SMITH CASSETTE LOT L1002 CALIBRATION CODE FG56 ANALYZER ID 00426 1 14 Example Displayed Printed Results of Patient Record Displayed Printed FETAL FIBRONECTIN 08 00 AM 08 21 01 PT XXXXXXXXXXXXXXXX RESULT POSITIVE gt RAPID fFN RESULT POSITIVE INTERNAL CONTROLS ANALYZER PASS USER JOHN SMITH CASSETTE PASS lt CASSETTE LOT L1002 CALIBRATION CODE FG56 CAL CODE FG56 ANALYZER ID 00426 INTERNAL CONTROLS CASSETTE LN L1002 ANALYZER PASS ANALYZER ID 00426 CASSETTE PASS ESC MAIN MENU TLiiqg System User Manual 1 15 Section 1 Introduction Example Displayed Printed Results of Test Counts Record Displayed FETAL FIBRONECTIN TEST COUNTS 08 00 AM 08 21 01 ANALYZER 00426 gt PATIENT 96 CONTROL 8 QCette 30 TLiig System User Manual Section 1 Introduction Printed FETAL FIBRONECTIN fFN TEST COUNT RECORD TIME 08 00a DATE 08 21 01 ANALYZER ID 00426 LIQUID CTL QCette 1 16 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 TLiig System User Manual Section 1 Introduction 1 17 Keypad 3 5 x 4 5 inches tactile membrane alphanumeric keys Dimensio
8. JOHN SMITH ENTER CONFIRM QCette SETUP ENTER QCette SN gt 001004 ENTER CONFIRM REMOVE CASSETTE PRESS ENTER TO CONTINUE 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 willl 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions INSERT QCette ENTER CONTINUE CASSETTE NOT INSERTED ENTER CONTINUE INITIALIZING QCette DO NOT REMOVE CASSETTE TEST WARNING This message will appear 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 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
9. Record N 1 Earliest Patient Record Use the lt and gt keys to view pages within a record Pg 1 of record Pg 2 of record Pg 3 of record gt gt lt 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 TLiia System User Manual 4 20 Section 4 Software Functions Detailed Descriptions ACCESS 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 fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP a Select option 2 on the ACCESS DATA MENU for DATA TRANSFER ACCESS DATA MENU 1 VIEW PRINT DATA 2 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 Adeza Biomedical DOES NOT provide software or technical support relating to the manipulation of data once it has left the analyzer TLiia System User Manual 4 21 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 attach
10. and print the result if AUTOPRINT is set to ON or it may be printed reprinted by pressing the PRINT ENTER key Qcette 08 00PM 08 21 01 SYSTEM PASS 6 Press ESC to return to the Main Menu USER JOHN SMITH T TLiia System User Manual 3 8 Section 3 General Operating Testing Instructions LIQUID CONTROLS Internal Incubation Mode 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 TLiig System User Manual Section 3 General Operating Testing Instructions fFN MAIN MENU 7 TEST COUNTS 8 LIQUID CONTROLS RUN CONTROL USER ID gt JOHN SMITH ENTER CONFIRM RUN CONTROL CASSETTE LOT gt L1002 ENTER ACCEPT 4 Select Negative or Positive Control 5 Enter the CONTROL LOT on bottle label and press ENTER 6 Insert cassette and press ENTER TLiig System User Manual Section 3 General Operating Testing Instructions CONTROL TEST MENU 1 NEGATIVE CONTROL 2 POSITIVE CONTROL NEGATIVE CTL LOT gt M1023 ENTER CONFIRM INTERNAL INCUBATION INSERT CASSETTE PRESS ENTER TO CONTINUE 3 10 ADD SAMPLE AND IMMEDIATELY PRESS ENTER 7 Add sample and immediately press ENTER 8 The analyzer will begin a 20 minute incubation countdown TEST IN PROCESS DO NOT REMOVE CASSETTE 19MIN 56SEC 9 Following incubation the analyzer
11. data record amp Delete Use DELETE to delete characters to the left of the cursor Right Arrow Key SPACE Next Page Use gt to go to the next page within a data record Space Use SPACE to enter a space in the position of the cursor TLiig System User Manual 1 4 Section 1 Introduction ESC TLiig System User Manual 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 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 4 arrows scroll keys TLiig System User Manual 1 6 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 4 arrow will scroll repetitively through the characters 2 C B A CASSETTE LOT CASSETTE LOT gt 2 gt C ENTER ACCEPT ENTER ACCEPT 2 Press 9 CASSETTE LOT gt C9 ENTER
12. result is positive if the signal intensity derived from the patient sample is greater than or equal to the reference calibration value specified by the calibration code The result is negative if the signal intensity derived from the patient sample is less than the reference calibration value specified by the calibration code The result is reported as invalid if specific internal test criteria have not been met TLiig System User Manual 1 1 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 TLiiq System User Manual Section 1 Introduction gt Q A oO m 7 AC PRINT eee off of OBS LE off 8 EWA gt f i TLiig System User Manual 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 t 4 to navigate through the alphanumeric keys when selecting an alpha character Scrolling through Data Records Use J 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 J to go to the next or previous screen of the menu Left Arrow Key 1 3 DELETE Previous Page Use lt to go to the previous page within a
13. 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 TLiig System User Manual Section 3 General Operating Testing Instructions TEST INPROCESS DO NOT REMOVE CASSETTE 19 MIN 56 SEC TEST INPROCESS ANALYZING DO NOT REMOVE CASSETTE FETAL FIBRONECTIN 08 00 AM 08 21 01 PT JANE DOE 123 RESULT POSITIVE gt DAILY QC NOTE TLijq QCette SETUP must be performed PRIOR to running the QCette as a quality control device See Section 4 for TLijqg QCette SETUP fFN MAIN MENU 1 From the Main Menu press 3 to select DAILY QC 1 TEST PATIENT 2 SET CALIBRATION 3 DAILY QC 2 Enter USER ID and press ENTER QCette USER ID gt JOHN SMITH ENTER CONFIRM 3 Enter the QCette SN on QCette plastic housing and press ENTER Qcette The serial number must be entered to proceed to the next step The ENTER QCette SN correct format is 6 numbers e g 001004 Enter all leading zeros gt 001004 ENTER ACCEPT NOTE The serial number entered at daily QC must be identical to the serial number entered at TLijg QCette setup TLiiqg System User Manual 3 7 Section 3 General Operating Testing Instructions 4 Insert the QCette and press ENTER The analyzer will begin the analysis of the QCette INSERT QCette ENTER CONTINUE TEST INPROCESS ANALYZING DO NOT REMOVE CASSETTE 5 When testing is complete the system will automatically display
14. will begin analysis of the cassette TEST INPROCESS ANALYZING DO NOT REMOVE 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 FETAL FIBRONECTIN 08 00 AM 08 21 01 NEG CTL M1023 11 Press ESC to return to the Main Menu RESULT PASS ae TLiig System User Manual 3 11 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 lt and gt 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 analyzer hardware TLiig System User Manual Section 3 General Operating Testing Instructions FETAL FIBRONECTIN 08 00 AM 08 21 01 PT JANE DOE 123 RESULT POSITIVE gt INTERNAL CONTROLS USER JOHN SMITH ANALYZER PASS CASSETTE PASS lt gt CAL CODE FG56 CASSETTE LN L1002 ANALYZER ID 00426 ESC MAIN MENU 3 12 INCUBATION MODE The incubation mode may be Internal incubation timed by anal
15. E ESC MAIN MENU FETAL FIBRONECTIN 08 00 AM 08 21 01 PT JANE DOE 123 RESULT POSITIVE gt INTERNAL CONTROLS USER JOHN SMITH ANALYZER PASS CASSETTE PASS lt gt CAL CODE FG56 CASSETTE LN L1002 ANALYZER 1 D 00426 ESC MAIN MENU DAILY QC Prior to running the TLijq QCette for the first time QCette SETUP must be performed See page 4 29 Refer to the TLijq 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 lt 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 all leading zeros TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 1 TEST PATIENT 2 SET CALIBRATION 3 DAILY QC QCette USER ID gt JOHN SMITH ENTER CONFIRM QCette ENTER QCette SN gt 001004 ENTER CONFIRM 4 10 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 pri
16. ESC MAIN MENU 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 lt 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 1 TEST PATIENT 2 SET CALIBRATION 3 DAILY QC TEST PATIENT USER ID gt JOHN SMITH ENTER CONFIRM TEST PATIENT CASSETTE LOT gt L1002 ENTER ACCEPT 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 t
17. ME 1 From the Main Menu select CHANGE SETUP by pressing the 4 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 fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP ape SETUP MENU 1 DATE TIME 2 AUTOPRINT 3 INCUBATION MODE For more details about setting the date and time see Section 4 Software Functions Detailed Descriptions TLiig System User Manual Section 2 Installation TLig QCette SETUP 1 From the Main Menu select CHANGE SETUP by pressing the 4 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 J or 4 to display QCette SETUP and follow the prompts fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP a SETUP MENU 1 DATE TIME 2 AUTOPRINT 3 INCUBATION MODE SETUP MENU 4 QCette SETUP For more details about setting up the TLijg QCette see Section 4 Software Functions Detailed Descriptions TLiig System User Manual Section 2 Installation FACTORY DEFAULT SETTINGS The TLiig 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 w
18. Q TLis System ADEZ User Manual IMPORTANT Read the entire manual before operating the TLijq System Adeza Biomedical Corporation 1240 Elko Drive Sunnyvale CA 94089 2212 USA Authorized Representative TEL For Technical Support according to IVDD 98 79 EC 1 877 945 0208 USA and Canada ne ccna 1 408 745 0975 Outside of the USA 30163 Hannover Germany FAX 1 408 745 0208 2003 Adeza Biomedical Corporation 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 Adeza Biomedical The TLi System is covered by U S patent numbers 6 267 722 and 6 394 952 The TLi 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 Adeza logo TLija and TLijg QCette are registered trademarks of Adeza Biomedical Printed in the USA 01188 04 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
19. TIENT Internal Incubation Mode fFN MAIN MENU 1 TEST PATIENT 2 SET CALIBRATION 3 DAILY QC 1 From the Main Menu press 1 to select TEST PATIENT 2 Enter USER ID and press ENTER TEST PATIENT USER ID gt JOHN SMITH ENTER CONFIRM 3 Enter the last two digits of the CASSETTE LOT on cassette TEST PATIENT pouch and press ENTER The lot number must be entered to CASSETTE LOT proceed to the next step gt L1002 ENTER ACCEPT 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 TLiig System User Manual 3 4 Section 3 General Operating Testing Instructions 4 Enter up to 16 alphanumeric characters for a PATIENT ID and press PATIENT ID ENTER gt JANE DOE 123 ENTER ACCEPT INTERNAL INCUBATION INSERT CASSETTE PRESS ENTER TO CONTINUE 5 Insert cassette and press ENTER 6 Add sample and immediately press ENTER ADD SAMPLE AND IMMEDIATELY PRESS ENTER TLijg System User Manual 3 5 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
20. bjected to extreme temperature variations e g near open windows ovens hot plates radiators direct sunlight TLiiqg System User Manual 2 1 Section 2 Installation UNPACKING TLijq 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 Adeza Customer Service The carton should contain the following parts accessories TLii Analyzer Power Adapter User Manual TLiig QCette NOTE Retain the shipping carton for future use If the analyzer needs to be shipped use the original shipping carton TLiig System User Manual 2 2 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 Adeza Customer Service The printer carton should contain the following parts accessories e Printer e Printer Labels 2 rolls e Power Cord e Printer Cable NOTE Retain the shipping carton for future use N SSR If the printer needs to be shipped use the original shipping carton TLiig System User Manual 2 3 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 modula
21. bration 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 2 POSITIVE 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions CASSETTE LOT CHANGED CALIBRATE SYSTEM L1002 ESC MAIN MENU CONTROL TEST MENU 1 NEGATIVE CONTROL 2 POSITIVE CONTROL NEGATIVE CTL LOT gt M1023 ENTER CONFIRM 4 15 This message will be displayed if a cassette is present in the analyzer prior to reaching the next screen Remove cassette and press ENTER REMOVE CASSETTE PRESS ENTER TO CONTINUE The analyzer then prompts the user to insert the cassette and press INTERNAL INCUBATION ENTER INSERT CASSETTE PRESS ENTER TO CONTINUE This message will be displayed if a cassette is not inserted Press ENTER to return to the previous screen SA ETIE NOY INSERTED ENTER CONTINUE TLiia System User Manual 4 16 Section 4 Software Functions Detailed Descriptions A two minute timer starts during which time this message flashes and the analyzer beeps Add co
22. echnical Service Department of Adeza Biomedical Corporation by calling 1 877 945 0208 for assistance and or instructions for obtaining repair of the system TLiig System User Manual 8 4 Section 8 Service and Warranty
23. ed Press ESC to return to the ACCESS DATA MENU TLijg System User Manual Section 4 Software Functions Detailed Descriptions PLEASE WAIT COMPUTER NOT PRESENT ESC MENU 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 4 and 7 keys TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP a VIEW SETUP CAL CODE FG56 DATE 08 21 01 TIME 08 00AM VIEW SETUP INCUBATION INTERNAL AUTOPRINT ON 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 fFN MAIN MENU 4 ACCESS DATA from the SETUP MENU 5 VIEW SETUP 6 CHANGE SETUP pl The SETUP MENU is displayed over two screens Each screen can be SETUP MENU accessed by using 4 and 7 keys 4 DATE TIME 2 AUTOPRINT Select option 1 on the SETUP MENU to change the DATE TIME 3 INCUBATION MODE 1 SETUP MENU 4 QCette SETUP TLijg System User Manual 4 24 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 2001 will be entered as 09 09 01 Use the lt key to delete incorrect entries
24. ed 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 Invalid results will not be stored in memory TLijg System User Manual Section 4 Software Functions Detailed Descriptions ARE YOU SURE YOU WANT TO CANCEL TEST ENTER CONTINUE ESC MAIN MENU FETAL FIBRONECTIN 08 00 AM 08 21 01 NEG CTL M1023 RESULT PASS gt INTERNAL CONTROLS USER JOHN SMITH ANALYZER PASS CASSETTE PASS lt gt CAL CODE FG56 CASSETTE LN L1002 ANALYZER 1 D 00426 ESC MAIN MENU 4 18 ACCESS 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 4 and 7 keys TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP N ACCESS DATA MENU 1 VIEW PRINT DATA 2 DATA TRANSFER ACCESS DATA MENU 1 PATIENT 2 QCette 3 CONTROLS ACCESS DATA MENU 4 CALIBRATION 4 19 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 7 and J keys to view other records in the category Most Recent Patient
25. er 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 TLiig System User Manual 6 4 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 TLijg System User Manual 6 5 Section 6 Printer SECTION 7 TROUBLESHOOTING GENERAL INFORMATION The TLiig 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 soluti
26. ervice CONTACT INFORMATION Adeza Biomedical Corporation 1240 Elko Drive Sunnyvale CA 94089 2212 USA www adeza com TECHNICAL SERVICE USA and Canada TECHNICAL SERVICE Outside of the USA Tel 1 877 945 0208 Tel 1 408 745 0975 Fax 1 408 745 0208 Fax 1 408 745 0208 TLiiqg System User Manual 8 1 Section 8 Service and Warranty Replacement Parts Item Catalog Number Analyzer Power Adapter 00989 Printer Power Cord 01206 Printer Serial Cable 01087 Printer Labels 01088 TLiig QCette 01175 User Manual 01207 Contact fFN Customer Service to order replacement parts CONTACT INFORMATION fFN CUSTOMER SERVICE USA ONLY fFN CUSTOMER SERVICE Outside of the USA Tel 1 888 PRETERM Tel 1 408 745 0975 1 888 773 8376 Fax 1 408 745 0208 Fax 1 913 859 6998 TLiig System User Manual Section 8 Service and Warranty TLijg System Analyzer Serial Number Printer Serial Number Shipment Date MANUFACTURER S WARRANTY Adeza Biomedical Corporation 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 Adeza Biomedical Corporation shall at its option replace with a new unit reconditioned unit or repair at no charge a unit that is found to be defective This warranty is subject to the following exceptions and limitat
27. f 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions ADEZA TLi SYSTEM VERSION 2 0 SYSTEM DIAGNOSTICS IN PROCESS ADEZA TLi SYSTEM VERSION 2 0 08 00AM 08 21 01 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 TLijg System User Manual 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 informat
28. he analyzer prior to reaching the next screen Remove cassette and press ENTER TLijg System User Manual Section 4 Software Functions Detailed Descriptions CASSETTE LOT CHANGED CALIBRATE SYSTEM L1002 ESC MAIN MENU PATIENT ID gt JANE DOE 123 ENTER ACCEPT REMOVE CASSETTE PRESS ENTER TO CONTINUE 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions INTERNAL INCUBATION INSERT CASSETTE PRESS ENTER TO CONTINUE CASSETTE NOT INSERTED ENTER CONTINUE ADD SAMPLE AND IMMEDIATELY PRESS ENTER 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 wil
29. iated with the result 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 DATA ACCESS mode Example Displayed Printed Results of Calibration Record Displayed Printed FETAL FIBRONECTIN 08 00 AM 08 21 01 SYSTEM CALIBRATED RAPID fFN CALIBRATION USER XXXXXXXXXXXX gt SYSTEM CALIBRATED TIME 08 00a DATE 08 21 01 CAL CODE FG56 USER JOHN SMITH 3 CASSETTE LOT L1002 CASSETTE LN L1002 CALIBRATION CODE FGS6 ANALYZER ID 00426 ANALYZER ID 00426 ESC MAIN MENU TLiio System User Manual 1 12 Section 1 Introduction Example Displayed Printed Results of TLijg QCette Displayed QCette 08 00 AM 08 21 01 SYSTEM PASS USER XXXXXXXXXXXX gt CAL CODE FG56 QCette SN 001004 ANALYZER 1 D 00426 ESC MAIN MENU TLiig System User Manual Section 1 Introduction Printed TLi QCette TIME 08 00a DATE 08 21 01 USER JOHN SMITH SERIAL 001004 ANALYZER ID 00426 1 13 Example Displayed Printed Results of Negative Control Record Displayed FETAL FIBRONECTIN 08 00 AM 08 21 01 NEG CTL M1023 RESULT PASS gt INTERNAL CONTROLS USER XXXXXXXXXXXXXX ANALYZER PASS CASSETTE PASS lt gt CAL CODE FG56 CASSETTE LN L1002 ANALYZER ID 00426 ESC MAIN MENU TLiig System User Manual Section 1 Introduction Printed fFN NEGATIVE CTL RESULT PASS TIME 08
30. ill 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 TLijg System User Manual 2 8 Section 2 Installation SECTION 3 GENERAL OPERATING TESTING INSTRUCTIONS After instrument installation the TLijq 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 ADEZA TLi SYSTEM VERSION 2 0 The screen will display SYSTEM DIAGNOSTICS If the analyzer fails SYSTEM DIAGNOSTICS the self test two beeps will sound otherwise the analyzer will go to the INPROCESS 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 ADEZA TLi SYSTEM VERSION 2 0 08 00AM 08 21 01
31. inted by pressing the PRINT ENTER key QCette results are SYSTEM PASS SYSTEM FAIL or INVALID Invalid results will not be stored in memory TLijg System User Manual Section 4 Software Functions Detailed Descriptions ARE YOU SURE YOU WANT TO CANCEL TEST ENTER CONTINUE ESC MAIN MENU QCette 08 00 AM 08 21 01 SYSTEM PASS USER JOHN SMITH gt CAL CODE FG56 QCette SN 00104 ANALYZER 1 D 00426 ESC MAIN MENU 4 13 LIQUID CONTROLS Internal Incubation Mode 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 lt 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 7 TEST COUNTS 8 LIQUID CONTROLS RUN CONTROL USER ID gt JOHN SMITH ENTER CONFIRM RUN CONTROL CASSETTE LOT gt L1002 ENTER ACCEPT 4 14 The analyzer automatically compares the CASSETTE LOT used to set cali
32. ion using the lt key TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 1 TEST PATIENT 2 SET CALIBRATION 3 DAILY QC SET CALIBRATION USER ID gt JOHN SMITH ENTER CONFIRM 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 Adeza 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 gt and lt 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions SET CALIBRATION CASSETTE LOT gt L1002 ENTER ACCEPT SET CALIBRATION CALIBRATION CODE gt FG56 ENTER ACCEPT FETAL FIBRONECTIN 08 00 AM 08 21 01 SYSTEM CALIBRATED USER JOHN SMITH gt CAL CODE FG56 CASSETTE LN L1002 ANALYZER ID 00426
33. ions 1 This warranty is limited to repair or replacement due to defects in parts or workmanship Adeza Biomedical Corporation shall not be required to make any repairs or replacements which are necessitated by abuse accidents alterations misuse neglect maintenance by other than Adeza Biomedical Corporation or failure to operate the system in accordance with manufacturer s instructions Further Adeza Biomedical Corporation assumes no liability for malfunction or damage to the system caused by the use of reagents other than reagents manufactured or recommended by Adeza Biomedical Corporation TLijg System User Manual 8 3 Section 8 Service and Warranty 2 Adeza Biomedical Corporation 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 EITHER IN FACT OR BY OPERATION OF LAW INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR USE WHICH ARE EXPRESSLY EXCLUDED AND IS THE ONLY WARRANTY GIVEN BY ADEZA BIOMEDICAL CORPORATION Limitations of Liability IN NO EVENT SHALL ADEZA BIOMEDICAL CORPORATION BE LIABLE FOR INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES EVEN IF ADEZA BIOMEDICAL CORPORATION HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES For warranty service and extended warranty service purchaser must contact the T
34. it firmly against the label roll as shown in Figure 1 b The labels will feed from the bottom of the roll is Ensure the power cord is connected Turn on the printer On Off switch is located at the back of the printer The green power light will flash and the printer motor will run as it looks for labels to feed TLiiqg System User Manual 6 2 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 Figure 2 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 TLijg System User Manual 6 3 Section 6 Printer REMOVING AN EMPTY LABEL ROLL When the printer is out of labels the green power light will flash 1 Leave the print
35. l take approximately 2 3 minutes TLijg System User Manual Section 4 Software Functions Detailed Descriptions SAMPLE NOT ADDED WITHIN ALLOTTED TIME ESC MAIN MENU TEST INPROCESS DO NOT REMOVE CASSETTE 19 MIN 56 SEC TEST INPROCESS ANALYZING DO NOT REMOVE CASSETTE TEST WARNING This message will be displayed 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 lt 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 Patient results are POSITIVE NEGATIVE or INVALID 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 analyzer hardware TLijg System User Manual Section 4 Software Functions Detailed Descriptions ARE YOU SURE YOU WANT TO CANCEL TEST ENTER CONTINU
36. logical 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 applied with a cloth or lab wiper only NEVER apply agents by spray e 10 Bleach e 75 Isopropyl Alcohol e BacDown disinfectant TLiia System User Manual 5 1 Section 5 Care of the Analyzer 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 TLiiqg System User Manual 6 1 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 Figure 1 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
37. not been established Please refer to Section 7 Troubleshooting TLijg System User Manual Section 4 Software Functions Detailed Descriptions 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 TEST COUNTS Option 7 on the Main Menu screen allows the user to view the number 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 lt and gt keys TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 7 TEST COUNTS 8 LIQUID CONTROLS FETAL FIBRONECTIN TEST COUNTS 08 00 AM 08 21 01 ANALYZER 00426 gt TEST COUNTS PATIENT 96 CONTROL 8 QCette 30 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 Liquids leaking into the analyzer may cause damage to the electrical components or possibly electrical A WARNING Liquids MUST NOT be allowed to seep into the analyzer Keep the analyzer dry at all times 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 bio
38. ns 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 TLiig System User Manual Section 1 Introduction 1 18 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 TLiig System User Manual Section 1 Introduction 1 19 CAUTIONS AND WARNINGS There are no known hazards associated with the TLijqg 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 Adeza Use of an incompatible power receptacle can cause shock and fire hazard CAUTION Use only the power adapter supplied by Adeza 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 seepage can damage internal components DO NOT clean the power adapter CAUTION Extreme heat can damage the display and other electronic components TLiio System User Manual 1 20 Section 1 Introduction WARNING Never apply cleaning reagents b
39. ntrol sample and immediately press ENTER If the 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions ADD SAMPLE AND IMMEDIATELY PRESS ENTER SAMPLE NOT ADDED WITHIN ALLOTTED TIME ESC MAIN MENU TEST INPROCESS DO NOT REMOVE CASSETTE 19MIN 56SEC TEST INPROCESS ANALYZING DO NOT REMOVE CASSETTE 4 17 TEST WARNING This message will be displayed 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 Liquid Control Data Record This record is displayed over three screens Each screen can be accessed by using the lt and keys The complete record will be print
40. ons Call Adeza Biomedical Technical Service for any questions related to the performance of your TLijg System ITEM PROBLEM SOURCE SOLUTION 1 Analyzer display Analyzer Power Cord Ensure analyzer power cord is firmly connected to screen is blank and Adapter analyzer Ensure analyzer power adapter is plugged into a grounded AC electrical outlet ON OFF Switch Ensure analyzer ON OFF switch is in ON position 2 Error Code is Analyzer Turn analyzer off and back on to reinitialize the system displayed when analyzer is first If the Error Code persists refer to Error Invalid Code table turned on TLiia System User Manual 7 1 Section 7 Troubleshooting ITEM PROBLEM SOURCE SOLUTION 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 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 Adeza Biomedical
41. or 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions CASSETTE CHANGED NNNNNN SETUP ANALYZER CTL ESC MAIN MENU REMOVE CASSETTE PRESS ENTER TO CONTINUE INSERT QCette ENTER CONTINUE CASSETTE NOT INSERTED ENTER CONTINUE 4 11 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 TLijg System User Manual 4 12 Section 4 Software Functions Detailed Descriptions TEST WARNING This message will be displayed 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 QCette Data Record This record will be displayed on two screens Each screen can be accessed by using the lt and keys The complete record will be printed automatically if AUTOPRINT is set to ON or it may be printed repr
42. orm QCette SETUP from the SETUP MENU The SETUP MENU is displayed over two screens Each screen can be accessed by using 4 and 7 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP pk SETUP MENU 1 DATE TIME 2 AUTOPRINT 3 INCUBATION MODE 4 SETUP MENU 4 QCette SETUP 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 lt 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 all leading 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions QCette SETUP USER ID gt
43. r 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 Caution Only power connectors provided with the TLi analyzer and printer may be used Any substitutions can result in damage to the TLi g 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 outlet TLiig System User Manual 2 4 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 ADEZA TLi SYSTEM The analyzer will perform SYSTEM DIAGNOSTICS a self test of the VERSION 2 0 analyzer components SYSTEM DIAGNOSTICS IN PROCESS If there is a problem after the self test a beep will sound to indicate an ADEZA TLi SYSTEM error and an error code will be displayed If an error code is displayed VERSION 2 0 refer to the troubleshooting section of the manual 08 00 AM 08 21 01 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 TLijg System User Manual 2 5 Section 2 Installation SETTING THE DATE AND TI
44. st 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 TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP pl SETUP MENU 1 DATE TIME 2 AUTOPRINT 3 INCUBATION MODE JV AUTOPRINT 1 ON 2 OFF ENTER ACCEPT 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 2 EXTERNAL Press ENTER to accept and return to the SETUP MENU TLijg System User Manual Section 4 Software Functions Detailed Descriptions fFN MAIN MENU 4 ACCESS DATA 5 VIEW SETUP 6 CHANGE SETUP pl SETUP MENU 1 DATE TIME 2 AUTOPRINT 3 INCUBATION MODE J INCUBATION MODE 1 INTERNAL 2 EXTERNAL ENTER ACCEPT CHANGE SETUP TLijg QCette SETUP Option 6 on the Main Menu screen allows the user to change the Date Time Autoprint or Incubation Mode or to perf
45. t Counts 4 33 5 Care of the Analyzer e General Cleaning 5 1 e Cleaning of Cassette Insertion Site 5 1 e Cleaning Agents Approved for Use 5 1 TLiig System User Manual Table of Contents vi Section Page 6 Printer e Loading Printer Labels 6 1 e Removing an Empty Label Roll 6 4 e Clearing Label Jams 6 5 7 Troubleshooting e General Information 7 1 e Troubleshooting Table 7 1 e Error Invalid Codes 7 7 8 Service and Warranty e Technical Service 8 1 e Contact Information Technical Service 8 1 e Replacement Parts 8 2 e Contact Information fFN Customer Service 8 2 e Warranty 8 3 TLiiqg System User Manual Table of Contents vii SECTION I INTRODUCTION For In Vitro Diagnostic Use Only IVD To be used by trained laboratory personnel INTENDED USE The Adeza Biomedical TLiig System is intended to be used in conjunction with the Rapid fFN Cassette the Rapid fFN Control Kit and the TLiig 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 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
46. und to comply with Underwriters Laboratories requirements and has been assigned Control Number 61PK User modification of this instrument may void such compliance TLiiqg System User Manual iii TABLE OF CONTENTS Section Page l Introduction e Intended Use 1 1 e General Description 1 1 e Components of the Analyzer 1 2 e Keypad 1 3 e Keypad Functions 1 3 e Keypad Entries 1 6 e Cassette Insertion Site 1 11 e Displayed Printed Results 1 12 e Specifications 1 17 e Cautions and Warnings 1 20 2 Installation e General 2 1 e Environmental Factors 2 1 e Unpacking 2 2 e System Setup 2 4 TLiig System User Manual Table of Contents iv Section Page e Getting Started 2 5 e Setting the Date and Time 2 6 TLig QCette Setup 2 7 e Factory Default Settings 2 8 3 General Operating Testing Instructions e Starting the System 3 1 e Set Calibration 3 2 e Test Patient 3 4 e Daily QC 3 7 e Liquid Controls 3 9 e Viewing Results On Screen 3 12 e Incubation Mode 3 13 e Internal Mode 3 13 e External Mode 3 14 4 Software Functions Detailed Descriptions e Startup Screen 4 1 e Main Menu 4 2 TLiig System User Manual Table of Contents Vv Section Page e Set Calibration 4 3 e Test Patient 4 5 e Daily QC 4 10 e Liquid Controls 4 14 e Access Data 4 19 e View Print Data 4 19 e Data Transfer 4 21 e View Setup 4 23 e Change Setup 4 24 e Date Time 4 24 e Autoprint 4 27 e Incubation Mode 4 28 e TLijg QCette Setup 4 29 e Tes
47. y 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 seepage 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 TLiio System User Manual 1 21 Section 1 Introduction SECTION 2 INSTALLATION GENERAL This section provides detailed installation instructions for the TLijq System Follow installation steps carefully to insure proper installation and operation ENVIRONMENTAL FACTORS The TLijq 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 su
48. ystem Repeat TLiiq QCette daily quality control as described in Section 4 If the QCette testing fails a second time call technical service TLiig System User Manual Section 7 Troubleshooting ITEM PROBLEM SOURCE SOLUTION 11 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 12 Invalid liquid control Analyzer Internal Refer to Error Invalid Code table test result Controls Analyzer Fail Cassette Pass Analyzer Internal Controls Analyzer Pass Cassette Fail Run TLijg 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 TLiig System User Manual Section 7 Troubleshooting ITEM PROBLEM SOURCE SOLUTION 13 Invalid patient test Analyzer Internal Refer to Error Invalid Code table result Controls Analyzer Fail Cassette Run TLiig 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
49. yzer 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 ADD SAMPLE AND IMMEDIATELY PRESS ENTER TEST INPROCESS DO NOT REMOVE CASSETTE 19MIN 56SEC TLiiqg System User Manual 3 13 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 TLiig System User Manual Section 3 General Operating Testing Instructions EXTERNAL INCUBATION WHEN TIME COMPLETE INSERT CASSETTE AND PRESS ENTER TEST INPROCESS ANALYZING DO NOT REMOVE CASSETTE 3 14 SECTION 4 SOFTWARE FUNCTIONS DETAILED DESCRIPTIONS STARTUP SCREEN When the analyzer is turned on the screen will display ADEZA TLi SYSTEM and the software version while performing an internal sel

User Manual - fFN (Fetal Fibronectin) Test

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