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IMPORTANT:

Read the entire manual before operating the Rapid fFN

®

10Q System.

Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Tel:

For Technical Support (USA and Canada)

1-800-442-9892

Fax:

1-508-263-2967

Tel:

For Technical Support (Outside the USA and Canada)

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:

900 994 197

Denmark:

8088 1378

South Africa:

0800 980 731

Finland:

0800 114 829

Sweden:

020 797 943

France:

0800 913 659

Switzerland:

0800 298 921

Germany:

0800 183 0227

UK:

0800 032 3318

Ireland (Rep):

1 800 554 144

Rest of the world:

00800.800.442.9892

Italy:

800 786 308

Intl Fax number:

0041.21.633.39.10

©2019 Hologic, Inc. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any
means in whole or in part without the prior written permission of Hologic, Inc.
The Rapid fFN

®

10Q Analyzer is covered by U.S. patent number 6,267,722. The Rapid fFN

®

10Q QCette is covered by U.S. patent number Des. 432,244.

The Hologic logo, Rapid fFN

®

10Q, and Rapid fFN

®

10Q

QCette are trademarks and/or registered trademarks of Hologic, Inc.

Printed in the USA

AW-19875-001 Rev. 001 8-2019

Hologic BVBA
Da Vincilaan 5
1930 Zaventem
Belgium

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Содержание Rapid fFN 10Q

Страница 1: ...User Manual...

Страница 2: ...0800 298 921 Germany 0800 183 0227 UK 0800 032 3318 Ireland Rep 1 800 554 144 Rest of the world 00800 800 442 9892 Italy 800 786 308 Intl Fax number 0041 21 633 39 10 2019 Hologic Inc All rights reser...

Страница 3: ...Description 1 1 Components of the Analyzer 1 2 Keypad 1 3 Cassette Insertion Site 1 4 Displayed Printed Results 1 5 Speci cations 1 6 Cautions and Warnings 1 8 2 Installation General 2 1 Environmenta...

Страница 4: ...3 1 Overview of Rapid fFN 10Q Analyzer Menu 3 2 Typical Menu Item Sequences 3 3 Key to User Entry Fields 3 4 Keypad Functions 3 5 Keypad Entries 3 6 Daily QC Quick Reference 3 11 Test Patient Quick Re...

Страница 5: ...4 16 Access Data 4 21 View Print Data 4 21 Data Transfer 4 23 View Setup 4 24 Change Setup 4 25 Date Time 4 25 Autoprint 4 28 Rapid fFN QCette Setup 4 29 Software Update 4 33 Test Counts 4 34 Usage R...

Страница 6: ...1 Removing an Empty Label Roll 6 4 Clearing Label Jams 6 5 7 Troubleshooting General Information 7 1 Troubleshooting Table 7 1 Error Invalid Codes 7 10 8 Service and Warranty Technical Support 8 1 Con...

Страница 7: ...rectional insert for the Rapid fFN 10Q Cassette for detailed intended use information GENERAL DESCRIPTION The Rapid fFN 10Q Analyzer is an electronic optical re ectance device that converts a colorime...

Страница 8: ...System User Manual 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 Inse...

Страница 9: ...Use keypad to enter alpha characters from A to Z Functions Up down left right arrows act as function keys to move through the menus and select options DELETE ESC escape SPACE PRINT ENTER function key...

Страница 10: ...Site contains a slightly concave trough designed to capture any uids that may have been spilled while applying sample to the Rapid fFN 10Q Cassette This area of the instrument should be cleaned regul...

Страница 11: ...mmediately after a test or in ACCESS DATA mode The example below demonstrates the display and printout of a Patient Test Example Displayed Printed Results of Patient Test Rapid fFN 10Q 03 00 PM 10 26...

Страница 12: ...C listed power supply Memory Capacity 50 Calibration Records 50 QCette Records 50 Control Records 1000 Patient Records Display 4 lines 20 characters per line Alphanumeric 5 x 8 matrix Supertwist LCD B...

Страница 13: ...nches Height 1 0 to 3 0 inches Weight 1 56 pounds Operating Temperature 15 to 30 C 59 to 86 F Operating Humidity 20 to 80 non condensing A C Supply 100 240VAC 50 60 Hz 0 7A Input Connector Coaxial pow...

Страница 14: ...r is connected to an AC electrical outlet that provides voltage and current speci ed by Hologic Use of an incompatible power receptacle can cause shock and re hazard CAUTION Use only the power adapter...

Страница 15: ...o 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 b...

Страница 16: ...d used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in whi...

Страница 17: ...ration of the device Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded intentional RF sources as these may interfere with the proper operation Thi...

Страница 18: ...logic 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 are...

Страница 19: ...ologic Contact Information Corporate Headquarters Hologic Inc 250 Campus Drive Marlborough MA 01752 USA Tel USA and Canada 1 800 442 9892 1 508 263 2900 Fax 1 508 263 2967 Authorized Representative Ou...

Страница 20: ...e used on this instrument Warning refer to accompanying documents Manufactured by Waste Electrical and Electronic Equipment contact Hologic for disposal of the instrument Authorized Representative in...

Страница 21: ...s up to 2000 m Maximum relative humidity of 80 for temperatures up to 30 C Pollution Degree II in accordance with IEC 61010 1 Category II The Rapid fFN 10Q System is for use only in an o ce or a clean...

Страница 22: ...gns of damage If the analyzer is damaged immediately contact the carrier and Hologic Customer Service The carton should contain the following parts accessories Rapid fFN 10Q Analyzer Wall Mount Power...

Страница 23: ...damage If the printer is damaged immediately contact the carrier and Hologic Customer Service The printer carton should contain the following parts accessories Printer Printer Labels 1 roll Power Cor...

Страница 24: ...2 Plug the desktop power adapter output jack into the receptacle labeled 24V DC on the bottom of the printer Plug one end of the appropriate power cord into the desktop power adapter Plug the other en...

Страница 25: ...wer outlets 5 Plug the output jack from the wall mount power adapter into the rear of the analyzer at the receptacle marked 15 VDC Plug the wall mount adapter into an AC power outlet Caution Only powe...

Страница 26: ...perform SYSTEM DIAGNOSTICS a self test of the analyzer components If there is a problem after the self test a beep will sound to indicate an error and an error code will be displayed If an error code...

Страница 27: ...by pressing the to get to the second page of the Main Menu Press 6 for CHANGE SETUP This will display the SETUP MENU 2 From the SETUP MENU press 1 to display DATE TIME and follow the prompts For more...

Страница 28: ...efault setting is MM DD YY TIME FORMAT The default setting is 24 hour time SHUTDOWN The system may be left plugged in and idle when not in use If the system is to be shutdown make sure it is idle Move...

Страница 29: ...located on the left side of the instrument If the analyzer does not turn on see Section 7 Troubleshooting Item 1 Upon power up the analyzer displays the message INITIALIZING for 17 seconds Then it bee...

Страница 30: ...esults of patient tests QCette and Control checks and System Calibration results Allows for transfer of data via the data port 5 VIEW SETUP View current setup of cal code date time and autoprint setti...

Страница 31: ...ystem Installation Routine Daily Use New Lot of Cassettes 6 Set Date Time 3 Daily QC 2 Set Calibration 6 Select Autoprint On O 1 Test Patient 3 Daily QC 6 QCette Setup View Print Results 8 Liquid Cont...

Страница 32: ...Up to 16 characters Any combination of letters and numbers An entry must be made Cassette Lot Number 5 characters ANNNN where A Alpha N Number Enter the lot number exactly as it appears on the cassett...

Страница 33: ...ing through data records in ACCESS DATA mode Menu Screens Some menus require up to three screens to display all of the options Use to go to the next or previous screen of the menu Left Arrow Key Previ...

Страница 34: ...tive when a data record is on the display screen Escape Key Press ESC to return to the most recent Menu screen unless otherwise speci ed If ESC is pressed in any screen requiring data entry all entrie...

Страница 35: ...mber 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...

Страница 36: ...User Manual Section 3 General Operating Testing Instructions 3 Press each subsequent number 1 2 3 LEVEL 1 CONTROL LOT C912_ ENTER CONFIRM 4 Press ENTER after all entries have been made LEVEL 1 CONTROL...

Страница 37: ...ructions Example to enter Patient Name ABE 1 Press 2 Use or arrow until A appears on the display screen PATIENT ID 2 ENTER ACCEPT PATIENT ID A ENTER ACCEPT 2 Press 2 again Use or arrow until B appears...

Страница 38: ...Section 3 General Operating Testing Instructions 3 Press 3 to enter the next letter Use or arrow until E appears on the display screen PATIENT ID AB3 ENTER ACCEPT PATIENT ID ABE ENTER ACCEPT 4 Press E...

Страница 39: ...Main Menu select 3 DAILY QC Enter User ID and press ENTER Enter the QCette serial number or verify if it is already entered Insert QCette and press ENTER Results will be displayed and printed in 3 mi...

Страница 40: ...TER Enter the last two digits of the cassette lot on cassette pouch and press ENTER Enter the patient accession number and press ENTER Remove the patient cassette from its pouch Insert the cassette in...

Страница 41: ...patient sample and press ENTER The analyzer will begin a 7 minute incubation countdown Following incubation the analyzer will begin analysis of the cassette When testing is complete the system will di...

Страница 42: ...ter the cassette lot on cassette pouch and press ENTER Enter the CALIBRATION CODE on the cassette box and press ENTER Calibration results will be displayed and printed SET CALIBRATION USER ID JOHN SMI...

Страница 43: ...CONTROLS Enter User ID and press ENTER Enter the cassette lot on cassette pouch and press ENTER Select Level 1 or Level 2 Enter the control lot on bottle label and press ENTER RUN CONTROL USER ID JOH...

Страница 44: ...ntdown Following incubation the analyzer will begin analysis of the cassette When testing is complete the system will display and print the result Note Both a Level 1 and a Level 2 control sample must...

Страница 45: ...IN PROCESS HOLOGIC Rapid fFN 10Q VERSION 2 0 0 03 00 PM 10 26 13 Upon power up the analyzer displays the message INITIALIZING for 17 seconds Then it beeps and the analyzer will perform SYSTEM DIAGNOS...

Страница 46: ...ration Daily QC Access Data View Setup Change Setup Test Counts Liquid Controls and Usage Report Selecting the number in front of each option initiates that procedure or displays a submenu fFN MAIN ME...

Страница 47: ...tion must be set when changing cassette lots Note If the calibration has not been set menu option 2 will ash Calibration must be set before the analyzer can be used for testing The USER ID must be ent...

Страница 48: ...ric 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 t...

Страница 49: ...ANALYZER ID G0237 Calibration Data Record This record is displayed over two screens Each screen can be accessed by using the and keys The complete record will be printed automatically if AUTOPRINT is...

Страница 50: ...E 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 requi...

Страница 51: ...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 The PATIENT ID must be ente...

Страница 52: ...s ENTER to return to the previous screen The analyzer will check that a Rapid fFN 10Q Cassette is properly inserted A 30 second timer starts during which time this message ashes and the analyzer beeps...

Страница 53: ...ple is added the analyzer will begin a 7 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 54: ...cord will be printed automatically if AUTOPRINT is set to ON or it may be printed reprinted by pressing the PRINT ENTER key Display and Printout Patient results are displayed as the fFN concentration...

Страница 55: ...ooting Item 13 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 sam...

Страница 56: ...n Menu screen allows the user to run the QCette The USER ID must be entered to proceed to the next step Press ENTER to accept the ID This eld will accept 15 alpha or numeric characters The QCette SN s...

Страница 57: ...the correct QCette This message will be displayed if a cassette is present in the analyzer prior to reaching the next screen Remove cassette and press ENTER The analyzer then prompts the user to inser...

Страница 58: ...esults are displayed The analysis will take approximately 2 3 minutes TEST WARNING This message will be displayed if ESC was pressed during testing Lines 1 and 2 will ash prompting the user to select...

Страница 59: ...alyzer displays the PASS or FAIL result and the fFN concentration for each QCette level LVL1 and LVL2 A FAIL result should be repeated See Section 7 Troubleshooting Items 9 and 10 QCette 03 00 PM 10 2...

Страница 60: ...ic characters 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...

Страница 61: ...splayed and the user is prompted to recalibrate the system From the CONTROL TEST MENU select 1 LEVEL 1 control or 2 LEVEL 2 control Enter the control lot number and press ENTER This eld will accept up...

Страница 62: ...Press ENTER to return to the previous screen The analyzer will check that a Rapid fFN 10Q Cassette is properly inserted A 30 second timer starts during which time this message ashes and the analyzer b...

Страница 63: ...eriod the analyzer will begin the analysis of the cassette Do not disturb the analyzer until the results are displayed The analysis will take approximately 2 3 minutes TEST WARNING This message will b...

Страница 64: ...by using the and keys The complete record will be printed automatically if AUTOPRINT is set to ON or it may be printed reprinted by pressing the PRINT ENTER key Control results are displayed as the fF...

Страница 65: ...he 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 u...

Страница 66: ...Use the and keys to view other records in the category Use the and keys to view pages within a record Pg 1 of record Pg 2 of record Pg 3 of record Printing the record The record displayed may be print...

Страница 67: ...led DATA of the analyzer Connect the other end of the interface cable to the appropriate port of a computer Note Data transferred to a computer is in ASCII format Capture and organization of the trans...

Страница 68: ...Main Menu screen allows the user to view current settings without editing them VIEW SETUP is displayed over two screens Each screen can be accessed by using and keys fFN MAIN MENU 4 ACCESS DATA 5 VIEW...

Страница 69: ...ser to change the DATE TIME Autoprint or to perform QCette Setup from the SETUP MENU This option also allows Hologic Technical Support to update the software version Select option 1 on the SETUP MENU...

Страница 70: ...continue Single digit months and days must be preceded by a zero e g August 10 2013 will be entered as 08 10 13 Use the key to delete incorrect entries Press ENTER to accept Select 1 for 12 HOUR AM P...

Страница 71: ...o delete incorrect entries Use the keys to choose AM PM Press ENTER to accept and return to the SETUP MENU 24 Hour Format Enter the time at the cursor position on the TIME display Single digit hours o...

Страница 72: ...to update the software version Select option 2 on the SETUP MENU to change AUTOPRINT Autoprint automatically prints test results when set in the ON position When set in the OFF position printouts may...

Страница 73: ...lows Hologic Technical Support to update the software version The QCette SETUP initializes the QCette for use in evaluating the performance of the analyzer During the initialization process the perfor...

Страница 74: ...he serial number is entered in the correct format six numeric characters e g 004640 Enter all leading zeros This message will be displayed if a cassette is present in the analyzer prior to reaching th...

Страница 75: ...ts are displayed The initialization process will take approximately 10 minutes Initialization can be terminated by pressing ESC TEST WARNING This message will appear if ESC was pressed during testing...

Страница 76: ...QCette Setup this message will be displayed SETUP COMPLETE indicates that the performance criteria of the analyzer have been established Display and Printout This message will be displayed if the QCe...

Страница 77: ...the DATE TIME Autoprint or to perform QCette Setup from the SETUP MENU This option also allows Hologic Technical Support to update the software version Software updates to the Rapid fFN 10Q System ca...

Страница 78: ...a Test Counts Report TCR TEST COUNTS are displayed over two screens Each screen can be accessed by using the and keys Display and Printout fFN MAIN MENU 7 TEST COUNTS 8 LIQUID CONTROLS 9 USAGE REPORT...

Страница 79: ...n The second screen scrolls forward and back among the months using the and keys to display each month Display and Printout fFN MAIN MENU 7 TEST COUNTS 8 LIQUID CONTROLS 9 USAGE REPORT USAGE REPORT S...

Страница 80: ...solvents of any type on any part of the analyzer Solvents can damage the display and keypad CLEANING OF CASSETTE INSERTION SITE The cassette insertion site can come into contact with biological uids...

Страница 81: ...are that is packaged with the printer 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 s...

Страница 82: ...roll as shown in Figure 1 b Make sure there is no gap between the roll and the spool The labels will feed from the bottom of the roll 6 Ensure the power cord is connected Turn on the printer by pluggi...

Страница 83: ...e end and carry the labels through the printer and out the exit slot The printer will stop feeding automatically at the end of the rst label If the motor stops running while still in the process of lo...

Страница 84: ...e 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 butt...

Страница 85: ...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...

Страница 86: ...he level on the left of the printer forward to release the pressure of the print head against the label 6 To reassemble the printer bezel slide the cover back on making sure to engage the tabs that ar...

Страница 87: ...all Hologic Inc Technical Support for any questions related to the performance of your Rapid fFN 10Q System ITEM PROBLEM SOURCE SOLUTION 1 Analyzer display screen is blank Analyzer Power Cord and or A...

Страница 88: ...umb drive from the USB port Turn on the analyzer Proceed with testing 4 Analysis process is interrupted and or unusual characters appear on display screen and the analyzer does not respond to keypad i...

Страница 89: ...cord is plugged into a grounded AC electrical outlet Disconnect and reconnect the power cord Be sure the power indicator light is on USB Cable Ensure USB cable is connected to the printer and the ana...

Страница 90: ...lyzer 7 Analyzer turned o after calibration or power failure occurred after calibration Power The calibration remains in memory Reset calibration only if prompted by analyzer 8 Cassette or QCette cann...

Страница 91: ...Turn analyzer o and back on to reinitialize the system Ensure QCette is clean and not damaged The QCette can be cleaned with canned air Repeat QCette setup as described in Section 4 If QCette setup i...

Страница 92: ...on the device matches the serial number programmed in the analyzer indicated on the Daily QC printout Ensure QCette is clean and not damaged The QCette may be cleaned with canned air Run 3 Daily QC I...

Страница 93: ...instrument matches the cal code on the cassette box Verify the control has not expired and is neither cloudy nor discolored If contamination of the controls is suspected open a new box of controls Rev...

Страница 94: ...a new cassette If both pass no further troubleshooting is required If the Daily QC result is Fail call Technical Support Internal Controls Analyzer QC Pass Cassette QC Fail Verify that 200 uL of cont...

Страница 95: ...ent Test result is Invalid call Technical Support Internal Controls Analyzer QC Pass Cassette QC Fail Verify that 200 uL of sample was dispensed Review the Rapid fFN 10Q Cassette Kit directional inser...

Страница 96: ...port 142B Sensor Error Turn analyzer o and back on to reinitialize the system Retest Daily QC If Daily QC passes continue with normal operation If Daily QC fails contact Technical Support 622 Possible...

Страница 97: ...lyzer o and back on to reinitialize the system Identify if there is any new source of bright light recent relocation near a window lab lights replaced window blinds open Remove the source of excess li...

Страница 98: ...reliably with minimal attention If a problem should occur refer to Section 7 Troubleshooting For analyzer service call Hologic Inc Technical Support Printer The printer is a self contained instrument...

Страница 99: ...64 Austria 0800 291 919 Portugal 800 841 034 Belgium 0800 773 78 Spain 900 994 197 Denmark 8088 1378 South Africa 0800 980 731 Finland 0800 114 829 Sweden 020 797 943 France 0800 913 659 Switzerland...

Страница 100: ...10Q QCette PRD 01021 Rapid fFN 10Q Liquid Controls Kit PRD 01019 Specimen Collection Kit PRD 01020 Rapid fFN Cassettes 26 pack box PRD 01018 Rapid fFN 10Q System User Manual MAN 06422 001 Contact fFN...

Страница 101: ...Manual Section 8 Service and Warranty fFN CUSTOMER SERVICE Outside the USA and Canada Please contact your nearest location To nd the nearest location please visit www ntest com or www hologic com or...

Страница 102: ...ned unit 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 def...

Страница 103: ...R BY OPERATION OF LAW 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 SH...

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