Hologic Rapid fFN 10Q User Manual
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Hologic Rapid fFN 10Q User Manual

Hologic Rapid fFN 10Q User Manual

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  • Page 1 User Manual...
  • Page 2 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.

  • Page 3: Table Of Contents

    • Specifi cations • Cautions and Warnings Installation • General • Environmental Factors • Unpacking • System Setup • Getting Started • Setting the Date and Time • Factory Default Settings Rapid fFN 10Q System User Manual Table of Contents...
  • Page 4 Section Page • Shutdown • Extended Shutdown General Operating/Testing Instructions • Starting the System • Overview of Rapid fFN 10Q Analyzer Menu • Typical Menu Item Sequences • Key to User Entry Fields • Keypad Functions • Keypad Entries •...
  • Page 5 • Software Update 4-33 • Test Counts 4-34 • Usage Report 4-35 Care of the Analyzer • General Cleaning • Cleaning of Cassette Insertion Site • Cleaning Agents Approved for Use Rapid fFN 10Q System User Manual Table of Contents...
  • Page 6 • Troubleshooting Table • Error/Invalid Codes 7-10 Service and Warranty • Technical Support • Contact Information — Technical Support • Replacement Parts • Contact Information — fFN Customer Service • Warranty Rapid fFN 10Q System User Manual Table of Contents...

  • Page 7: Intended Use

    10Q System is an in vitro diagnostic device intended to be used in conjunction with the ® Rapid fFN 10Q Cassette, the Rapid fFN Control Kit, and the Rapid fFN 10Q QCette for the detection of fetal fi bronectin (fFN) in cervicovaginal secretions. Refer to the directional insert for the Rapid fFN 10Q Cassette for detailed intended use information.

  • Page 8: Components Of The Analyzer

    COMPONENTS OF THE ANALYZER The major components of the analyzer are the display screen, the keypad, and the cassette insertion site. Display Screen Cassette Insertion Site Keypad Rapid fFN 10Q System User Manual 1–2 Section 1 — Introduction...

  • Page 9: Keypad

    DELETE, ESC (escape), SPACE, PRINT/ENTER function keys provide further functionality for using the menu options. See Chapter 3, General Operating, for a full description of using the keypad. Rapid fFN 10Q System User Manual 1–3 Section 1 — Introduction...

  • Page 10: Cassette Insertion Site

    The Cassette Insertion Site contains a slightly concave trough designed to capture any fl uids that may have been spilled while applying sample to the Rapid fFN 10Q Cassette. This area of the instrument should be cleaned regularly (see Section 5, Care of the Analyzer).

  • Page 11: Displayed/Printed Results

    CASSETTE LOT: L1002 CASSETTE QC: PASS CALIBRATION CODE: 95HYA-76YTT ANALYZER ID: G0237 CAL CODE:95HYA-76YTT INTERNAL CONTROLS CASSETTE LN:L1002 ANALYZER QC: PASS ANALYZER ID:G0237 CASSETTE QC: PASS ESC-MAIN MENU Displayed Printed Rapid fFN 10Q System User Manual 1–5 Section 1 — Introduction...

  • Page 12: Specifications

    1000 Patient Records Display 4 lines 20 characters per line Alphanumeric 5 x 8 matrix Supertwist LCD Black characters with gray background Keypad 3.5 x 4.5 inches Tactile membrane Alphanumeric keys Rapid fFN 10Q System User Manual 1–6 Section 1 — Introduction...
  • Page 13 20% to 80%, non-condensing A.C. Supply 100-240VAC 50-60 Hz 0.7A Input Connector Coaxial power plug with positive center conductor Output Connectors 9 pin data connector 2 host USB connectors Rapid fFN 10Q System User Manual 1–7 Section 1 — Introduction...

  • Page 14: Cautions And Warnings

    CAUTIONS AND WARNINGS There are no known hazards associated with the Rapid fFN 10Q 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.
  • Page 15 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. Rapid fFN 10Q System User Manual 1–9 Section 1 — Introduction...
  • Page 16 This equipment has been tested and found to be in compliance with the following standards per the IVD Directive: EN61326-2-6 Electrical Equipment for Measurement, Control and Laboratory Use; EMC Requirements; In Vitro Diagnostic (IVD) Medical Equipment. Rapid fFN 10Q System User Manual 1–10 Section 1 — Introduction...
  • Page 17 Industry Canada Regulation: Interference-Causing Equipment Standards - Digital Apparatus CAN/CSA C22.2 No. 61010-2-101 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use - Part 1: General Requirements, with ETL or equivalent Approval Mark Rapid fFN 10Q System User Manual 1–11 Section 1 — Introduction...
  • Page 18 Your Responsibility As a Hologic customer, you are responsible for ensuring that devices marked with the symbol shown below are not placed into the municipal waste system unless authorized to do so by the authorities in your area. Please contact Hologic (see below) prior to disposing any electrical equipment provided by Hologic.
  • Page 19 250 Campus Drive Marlborough, MA 01752 USA Tel: (USA and Canada) 1-800-442-9892 1-508-263-2900 Fax: 1-508-263-2967 Authorized Hologic BVBA Representative - Outside of U.S. Da Vincilaan 5 1930 Zaventem Belgium Rapid fFN 10Q System User Manual 1–13 Section 1 — Introduction...
  • Page 20 Authorized Representative in Equipment - contact Hologic the European Community for disposal of the instrument. Store between 15°C and 30°C Catalog Number For in vitro diagnostic testing Serial Number Rapid fFN 10Q System User Manual 1–14 Section 1 — Introduction...

  • Page 21: Installation

    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 offi ce or a clean laboratory environment. •...

  • Page 22: Unpacking

    • User Manual • Rapid fFN 10Q QCette ® Note: Retain the shipping carton for future use. If the analyzer needs to be shipped, use the original shipping carton. Rapid fFN 10Q System User Manual 2–2 Section 2 — Installation...
  • Page 23 Printer Carefully remove the printer and accessories from the shipping carton. Inspect the carton and the printer for visible signs of damage. If the printer is damaged, immediately contact the carrier and Hologic Customer Service. The printer carton should contain the following parts/accessories: •...

  • Page 24: System Setup

    fl at surface. Plug the other end of the USB cable into either of the USB ports labeled ‘Printer’ on the analyzer. Analyzer System Printer Rapid fFN 10Q System User Manual 2–4 Section 2 — Installation...
  • Page 25 15 VDC. Plug the wall mount adapter into an AC power outlet. Caution: Only power adapters provided with the Rapid fFN 10Q Analyzer and printer may be used. Any substitutions can result in damage to the Rapid fFN 10Q Analyzer and printer.

  • Page 26: Getting Started

    Once SYSTEM DIAGNOSTICS is complete, the display will change to the software VERSION, DATE, and TIME for fi ve seconds, and then to the fFN Main Menu. The date and time may need to be reset for your time zone. Rapid fFN 10Q System User Manual 2–6 Section 2 — Installation...

  • Page 27: Setting The Date And Time

    2. From the SETUP MENU, press 1 to display DATE/TIME and follow the 3-QCette SETUP prompts. For more details about setting the date and time, see Section 4, Software Functions – Detailed Descriptions. Rapid fFN 10Q System User Manual 2–7 Section 2 — Installation...

  • Page 28: Factory Default Settings

    FACTORY DEFAULT SETTINGS The Rapid fFN 10Q System uses the following default settings. To customize the unit to your laboratory requirements, refer to Section 4, Software Functions — Detailed Descriptions. The Default Settings are as follows: AUTOPRINT Factory setting is Autoprint ON. After every result, the printer will generate a printed result.

  • Page 29: General Operating/Testing Instructions

    SECTION 3 — GENERAL OPERATING / TESTING INSTRUCTIONS After instrument installation, the Rapid fFN 10Q 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.

  • Page 30: Overview Of Rapid Ffn 10Q Analyzer Menu

    View/print the number of tests performed on the analyzer to date: Patient, Control, QCette. 8-LIQUID CONTROLS Runs the liquid control samples on the analyzer to ensure the Rapid fFN 10Q System functions properly. Performed at installation and with every cassette lot change or shipment.

  • Page 31: Typical Menu Item Sequences

    1 Test Patient Daily QC QCette Setup View/Print Results Liquid Controls Set Calibration 1 Test Patient Daily QC View/Print Results Liquid Controls 1 Test Patient View/Print Results Rapid fFN 10Q System User Manual 3–3 Section 3 — General Operating/Testing Instructions...

  • Page 32: Key To User Entry Fields

    Liquid Control Lot Up to 12 characters Enter the liquid control lot number exactly as it Number appears on the bottle. An entry must be made. Rapid fFN 10Q System User Manual 3–4 Section 3 — General Operating/Testing Instructions...

  • Page 33: Keypad Functions

    Next Page — Use → to go to the next page within a data record. Space — Use SPACE to enter a space in the position of the cursor. Rapid fFN 10Q System User Manual 3–5 Section 3 — General Operating/Testing Instructions...

  • Page 34: Keypad Entries

    Entries of numerical characters require pressing the appropriate numeric key. Entries of alpha characters require pressing the numeric key containing the alpha character and the ↑ or ↓ arrows (scroll keys). Rapid fFN 10Q System User Manual 3–6 Section 3 — General Operating/Testing Instructions...
  • Page 35 LEVEL 1 CONTROL LOT # LEVEL 1 CONTROL LOT # >C >2 ENTER - CONFIRM ENTER - CONFIRM 2 – Press 9. LEVEL 1 CONTROL LOT # >C9 ENTER - CONFIRM Rapid fFN 10Q System User Manual 3–7 Section 3 — General Operating/Testing Instructions...
  • Page 36 LEVEL 1 CONTROL LOT # >C912_ ENTER - CONFIRM 4 – Press ENTER after all entries have been made. LEVEL 1 CONTROL LOT # >C9123 ENTER - CONFIRM Rapid fFN 10Q System User Manual 3–8 Section 3 — General Operating/Testing Instructions...
  • Page 37 2 – Press 2 again. Use ↑ or ↓ arrow until B appears on the display screen. PATIENT ID PATIENT ID >A2 >AB ENTER - ACCEPT ENTER - ACCEPT Rapid fFN 10Q System User Manual 3–9 Section 3 — General Operating/Testing Instructions...
  • Page 38 3 – Press 3 to enter the next letter. Use ↑ or ↓ arrow until E appears on the display screen. PATIENT ID PATIENT ID >ABE >AB3 ENTER - ACCEPT ENTER - ACCEPT 4 – Press ENTER after all entries have been made. Rapid fFN 10Q System User Manual 3–10 Section 3 — General Operating/Testing Instructions...

  • Page 39: Daily Qc - Quick Reference

    TEST IN PROCESS ANALYZING If the QCette does not pass, see Section 7, Troubleshooting, Item 10. DO NOT REMOVE CASSETTE QCette 03:00 PM 10/26/13 SYSTEM: PASS USER:JOHN SMITH Rapid fFN 10Q System User Manual 3–11 Section 3 — General Operating/Testing Instructions...

  • Page 40: Test Patient - Quick Reference

    Enter the patient accession number and press ENTER. >JANE DOE 123 ENTER-ACCEPT Remove the patient cassette from its pouch. INSERT CASSETTE Insert the cassette into the analyzer and press ENTER. PRESS ENTER TO CONTINUE Rapid fFN 10Q System User Manual 3–12 Section 3 — General Operating/Testing Instructions...
  • Page 41 The analyzer will check that a Rapid fFN 10Q Cassette is properly inserted. CHECKING CASSETTE DO NOT REMOVE The instrument will beep repeatedly and the display will read ADD SAMPLE CASSETTE AND IMMEDIATELY PRESS ENTER. ADD SAMPLE Add 200 uL of patient sample and press ENTER.

  • Page 42: Set Calibration - Quick Reference

    Enter the CALIBRATION CODE# (on the cassette box) and press ENTER. >95HYA-76YTT ENTER-ACCEPT Calibration results will be displayed and printed. Rapid fFN 10Q 03:00 PM 10/26/13 SYSTEM CALIBRATED USER:JOHN SMITH Rapid fFN 10Q System User Manual 3–14 Section 3 — General Operating/Testing Instructions...

  • Page 43: Liquid Controls - Quick Reference

    CONTROL TEST MENU 1-LEVEL 1 Select Level 1 or Level 2. 2-LEVEL 2 LEVEL 1 CONTROL LOT# Enter the control lot# (on bottle label) and press ENTER. >C9123 ENTER-CONFIRM Rapid fFN 10Q System User Manual 3–15 Section 3 — General Operating/Testing Instructions...
  • Page 44 INSERT CASSETTE PRESS ENTER TO CONTINUE CHECKING CASSETTE The analyzer will check that a Rapid fFN 10Q Cassette is properly inserted. DO NOT REMOVE CASSETTE The instrument will beep repeatedly and the display will read ADD SAMPLE AND IMMEDIATELY PRESS ENTER.

  • Page 45: Software Functions - Detailed Descriptions

    Following the self-test, the analyzer displays the software version and the Rapid fFN 10Q current date and time for fi ve seconds before displaying the Main Menu. VERSION 2.0.0 03:00 PM 10/26/13 Rapid fFN 10Q System User Manual 4–1 Software Functions — STARTUP SCREEN Section 4 —...

  • Page 46: Main Menu

    3-DAILY QC fFN MAIN MENU 4-ACCESS DATA 5-VIEW SETUP 6-CHANGE SETUP fFN MAIN MENU 7-TEST COUNTS 8-LIQUID CONTROLS 9-USAGE REPORT Rapid fFN 10Q System User Manual 4–2 Software Functions — MAIN MENU Section 4 —...

  • Page 47: Set Calibration

    The USER ID must be entered to proceed to the next step. Press ENTER to ENTER-CONFIRM accept the ID. This fi eld will accept 15 alpha or numeric characters. Rapid fFN 10Q System User Manual 4–3 Software Functions — SET CALIBRATION...
  • Page 48 10 alphanumeric characters with a dash in the middle. Enter the calibration code exactly as it is given on the box. Note: The calibration code is established by Hologic for each lot of Rapid fFN 10Q Cassettes. Rapid fFN 10Q System User Manual 4–4...
  • Page 49 ANALYZER ID G0237 TIME: 03:00 PM DATE: 10/26/13 ESC-MAIN MENU USER:JOHN SMITH USER: JOHN SMITH Display and Printout CASSETTE LOT: L1002 CALIBRATION CODE: 95HYA-76YTT ANALYZER ID: G0237 Rapid fFN 10Q System User Manual 4–5 Software Functions — SET CALIBRATION Section 4 —...

  • Page 50: Test Patient

    CASSETTE LOT# alpha character followed by four numeric characters (e.g., L1002). >L1002 ENTER-ACCEPT Note: If the CASSETTE LOT# has changed, SET CALIBRATION must be performed. Rapid fFN 10Q System User Manual 4–6 Software Functions — TEST PATIENT Section 4 —...
  • Page 51 This message will be displayed if a cassette is present in the analyzer prior to reaching the next screen. Remove cassette and press ENTER. PRESS ENTER TO CONTINUE Rapid fFN 10Q System User Manual 4–7 Software Functions — TEST PATIENT Section 4 —...
  • Page 52 INSERTED ENTER to return to the previous screen. ENTER-CONTINUE CHECKING CASSETTE The analyzer will check that a Rapid fFN 10Q Cassette is properly inserted. DO NOT REMOVE CASSETTE A 30-second timer starts during which time this message fl ashes and the analyzer beeps.
  • Page 53 Do not disturb the analyzer until the results are DO NOT REMOVE displayed. The analysis will take approximately 2–3 minutes. CASSETTE Rapid fFN 10Q System User Manual 4–9 Software Functions — TEST PATIENT Section 4 —...
  • Page 54 ANALYZER ID:G0237 ANALYZER QC: PASS ESC-MAIN MENU CASSETTE QC: PASS Display and Printout Patient results are displayed as the fFN concentration in ng/mL, or INVALID. Rapid fFN 10Q System User Manual 4–10 Software Functions — TEST PATIENT Section 4 —...
  • Page 55 Rapid fFN test. These internal controls check for (1) a threshold level of signal at the procedural control line, (2) proper sample fl ow across the Rapid fFN 10Q Cassette, (3) absence of conjugate aggregation, and (4) proper functioning of the Rapid fFN 10Q Analyzer hardware.

  • Page 56: Daily Qc

    DAILY QC Prior to running the Rapid fFN 10Q QCette for the fi rst time, QCette SETUP ® must be performed. See page 4-29. Refer to the Rapid fFN 10Q QCette fFN MAIN MENU directional insert for more information. 1-TEST PATIENT 2-SET CALIBRATION Daily QC should be performed at least once every 24 hours.
  • Page 57 The analyzer then prompts the user to insert the QCette and press INSERT QCette ENTER. ENTER-CONTINUE This message will be displayed if the QCette is not inserted. Press QCette NOT ENTER to continue. INSERTED ENTER-CONTINUE Rapid fFN 10Q System User Manual 4–13 Software Functions — DAILY QC Section 4 —...
  • Page 58 ENTER to continue test, or ESC to end test. This message will ENTER-CONTINUE hold for 5 seconds and then revert back to its respective screen. ESC-MAIN MENU Rapid fFN 10Q System User Manual 4–14 Software Functions — DAILY QC Section 4 —...
  • Page 59 ANALYZER ID:G0237 QCette LEVEL 2: PASS [179 ng/mL] USER: JOHN SMITH ESC-MAIN MENU QCette SERIAL#: 006460 CALIBRATION CODE: 95HYA-76YTT ANALYZER ID: G0237 Display and Printout Rapid fFN 10Q System User Manual 4–15 Software Functions — DAILY QC Section 4 —...

  • Page 60: Liquid Controls

    >L1002 The software requires that the lot number is entered in the correct ENTER-ACCEPT format: one alpha character followed by four numeric characters (e.g., L1002). Rapid fFN 10Q System User Manual 4–16 Software Functions — LIQUID CONTROLS Section 4 —...
  • Page 61 This message will be displayed if a cassette is present in the analyzer prior to reaching the next screen. Remove cassette and press ENTER. PRESS ENTER TO CONTINUE Rapid fFN 10Q System User Manual 4–17 Software Functions — LIQUID CONTROLS Section 4 —...
  • Page 62 This message will be displayed if a cassette is not inserted. Press ENTER INSERTED to return to the previous screen. ENTER-CONTINUE CHECKING CASSETTE The analyzer will check that a Rapid fFN 10Q Cassette is properly DO NOT REMOVE inserted. CASSETTE ADD SAMPLE A 30-second timer starts during which time this message fl...
  • Page 63 5 seconds and then revert back to its respective screen. ESC-MAIN MENU If the test is cancelled, a new cassette will be required to repeat the 6 MIN 37 SEC test. Rapid fFN 10Q System User Manual 4–19 Software Functions — LIQUID CONTROLS Section 4 —...
  • Page 64 An out-of-range result or an INVALID result should be repeated. (See Section 7, Troubleshooting, Items 11 and 12.) USER:JOHN SMITH Rapid fFN 10Q HOLOGIC Rapid fFN® ANALYZER QC: PASS 03:00 PM 10/26/13 Rapid fFN 10Q LIQUID CTL RESULT CASSETTE QC: PASS LEVEL 1: M1023 fFN CONC: 31 ng/mL fFN: 31 ng/mL TIME: 03:00 PM DATE: 10/26/13...

  • Page 65: Access Data

    Each screen can be accessed by using ↓ 1-PATIENT and ↑ keys. 2-QCette 3-CONTROL ACCESS DATA MENU 4-CALIBRATION Rapid fFN 10Q System User Manual 4–21 Software Functions — ACCESS DATA — VIEW/PRINT DATA Section 4 —...
  • Page 66 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. Rapid fFN 10Q System User Manual 4–22 Software Functions — ACCESS DATA — VIEW/PRINT DATA...
  • Page 67 Note: Data transferred to a computer is in ASCII format. Capture and organization of the transferred data is done at the discretion of the user. Hologic, Inc. DOES NOT provide software or technical PLEASE WAIT support relating to the manipulation of data once it has left the analyzer.

  • Page 68: View Setup

    VIEW SETUP is displayed over two screens. Each screen can be CAL CODE:95HYA-76YTT accessed by using ↓ and ↑ keys. DATE: 10/26/13 TIME: 03:00 PM VIEW SETUP AUTOPRINT:ON Rapid fFN 10Q System User Manual 4–24 Software Functions — VIEW SETUP Section 4 —...

  • Page 69: Change Setup

    Option 6 on the Main Menu screen allows the user to change the 4-ACCESS DATA DATE/TIME, Autoprint, or to perform QCette Setup from the SETUP 5-VIEW SETUP MENU. This option also allows Hologic Technical Support to update 6-CHANGE SETUP the software version. SETUP MENU 1-DATE/TIME Select option 1 on the SETUP MENU to change the DATE/TIME.
  • Page 70 Select 1 for 12 HOUR (AM/PM) format or 2 for 24 HOUR format on the SET TIME SET TIME display. 1-12 HOUR 2-24 HOUR Rapid fFN 10Q System User Manual 4–26 Software Functions — CHANGE SETUP — DATE/TIME Section 4 —...
  • Page 71 09:09). Use the ← key to delete incorrect entries. ENTER-ACCEPT Press ENTER to accept and return to the SETUP MENU. Rapid fFN 10Q System User Manual 4–27 Software Functions — CHANGE SETUP — DATE/TIME Section 4 —...

  • Page 72: Autoprint

    Option 6 on the Main Menu screen allows the user to change the 4-ACCESS DATA DATE/TIME, AUTOPRINT or to perform QCette SETUP from the 5-VIEW SETUP SETUP MENU. This option also allows Hologic Technical Support to 6-CHANGE SETUP update the software version. SETUP MENU Select option 2 on the SETUP MENU to change AUTOPRINT.
  • Page 73 PRIOR to running the QCette as a quality 3-QCette SETUP control device. Select option 3 on the SETUP MENU to begin QCette SETUP. Rapid fFN 10Q System User Manual 4–29 Software Functions — CHANGE SETUP — Rapid fFN 10Q QCette® SETUP Section 4 —...
  • Page 74 ENTER. A two-minute timer starts during which time this message fl ashes and the analyzer beeps. Insert the QCette and press ENTER. ENTER-CONTINUE Rapid fFN 10Q System User Manual 4–30 Software Functions — CHANGE SETUP — Rapid fFN 10Q QCette® SETUP Section 4 —...
  • Page 75 ESC to end test. This message will hold for 5 seconds ENTER-CONTINUE and then revert back to its respective screen. ESC-MAIN MENU Rapid fFN 10Q System User Manual 4–31 Software Functions — CHANGE SETUP — Rapid fFN 10Q QCette® SETUP Section 4 —...
  • Page 76 If the QCette setup error occurs, see QCette Section 7, Troubleshooting, Item 9. SETUP ERROR NNNN ESC-MAIN MENU Rapid fFN 10Q System User Manual 4–32 Software Functions — CHANGE SETUP - SOFTWARE UPDATE Section 4 —...

  • Page 77: Software Update

    TIME, Autoprint, or to perform QCette Setup from the SETUP MENU. This 6-CHANGE SETUP option also allows Hologic Technical Support to update the software version. SETUP MENU Software updates to the Rapid fFN 10Q System can only be performed by 1-DATE/TIME Hologic Technical Support. 2-AUTOPRINT...

  • Page 78: Test Counts

    TEST COUNTS TIME: 03:03 PM DATE: 10/26/13 TEST COUNTS PATIENT:20 ANALYZER ID: G0237 03:03 PM 10/26/13 CONTROL:6 ANALYZER:G0237 QCette:22 PATIENT: Display and Printout LIQUID CTL: QCette: Rapid fFN 10Q System User Manual 4–34 Software Functions — TEST COUNTS Section 4 —...

  • Page 79: Usage Report

    TOTAL 00012 00013 RESULTS TOTAL 00009 00000 00000 0049 00051 00000 00000 00000 00000 00000 00000 00000 00000 00000 00000 Display and Printout 00049 00051 Rapid fFN 10Q System User Manual 4–35 Software Functions — USAGE REPORT Section 4 —...

  • Page 80: Care Of The Analyzer

    The following cleaning agents may be applied with a cloth or lab wiper only. NEVER apply agents by spray. • 10% Bleach in water • 75% Isopropyl Alcohol • General laboratory cleaning detergent with disinfectant properties Rapid fFN 10Q System User Manual 5–1 Section 5 — Care of the Anaylzer...

  • Page 81: Printer

    The right side slides in and out and can be removed entirely to load label rolls. 4. Remove the RIGHT SIDE of the spool by sliding it off the right end. Rapid fFN 10Q System User Manual 6–1...
  • Page 82 7. 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, Rapid fFN 10Q System User Manual 6–2 Section 6 — Printer...
  • Page 83 9. Insert the label spool into the printer. The spool will fi t into the raised shoulder slots in the printer. 10. Close the cover and the printer is ready to print labels. Rapid fFN 10Q System User Manual 6–3 Section 6 — Printer...

  • Page 84: Removing An Empty Label Roll

    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). Rapid fFN 10Q System User Manual 6–4 Section 6 — Printer...

  • Page 85: Clearing Label Jams

    4. If needed, the front bezel of the printer may be removed to better access the print head. Open the lid and gently pull up on the lip of the front cover (1, see below). Slide the piece forward (2). The bezel will pull off . Rapid fFN 10Q System User Manual 6–5...
  • Page 86 6. To reassemble the printer bezel, slide the cover back on, making sure to engage the tabs that are on the bottom as well as the top. Reload the roll of labels. Rapid fFN 10Q System User Manual 6–6 Section 6 — Printer...

  • Page 87: Troubleshooting

    SECTION 7 — TROUBLESHOOTING GENERAL INFORMATION The Rapid fFN 10Q Analyzer software is designed for easy troubleshooting. Always heed the beep tones and follow the display screen prompts to obtain the best performance from your system. The following table lists potential problems, sources of trouble, and recommended solutions.
  • Page 88 Reconnect the printer power cord to the electrical outlet. display screen, and the Turn on the analyzer. analyzer does not respond to Proceed with testing. keypad inputs. Rapid fFN 10Q System User Manual 7–2 Section 7 — Troubleshooting...
  • Page 89 Plug the printer in. Turn the analyzer off and back on. Recall plugged in when the test result on the analyzer display screen (4-ACCESS test was run. DATA). Press PRINT/ENTER on the analyzer to print the result. Rapid fFN 10Q System User Manual 7–3 Section 7 — Troubleshooting...
  • Page 90 If the cassette/QCette can be easily removed, proceed with the analyzer. testing. (Note: do not If the cassette/QCette cannot be easily removed, call try to force or Technical Support. pry it out of the analyzer.) Rapid fFN 10Q System User Manual 7–4 Section 7 — Troubleshooting...
  • Page 91 3-Daily QC, followed by 8-Liquid Controls. Do not bump or jar analyzer or QCette during the test. If the QCette setup fails a second time, call Technical Support. Rapid fFN 10Q System User Manual 7–5 Section 7 — Troubleshooting...
  • Page 92 If Daily QC fails, perform 6-3-QCette setup. If QCette setup is complete, run 3-Daily QC, followed by 8-Liquid Controls. If both pass, no further troubleshooting is required. If Daily QC fails a second time, call Technical Support. Rapid fFN 10Q System User Manual 7–6 Section 7 — Troubleshooting...
  • Page 93 ITEM PROBLEM SOURCE SOLUTION Liquid control Liquid Control Verify that the Rapid fFN 10Q Cassettes have not expired result is outside and have been stored properly. the range of Ensure the cal code programmed in the instrument matches acceptable the cal code on the cassette box.
  • Page 94 If control result is acceptable, no further troubleshooting is required. Do not bump or jar the analyzer or the cassette during the test. If control is invalid a second time, call Technical Support. Rapid fFN 10Q System User Manual 7–8 Section 7 — Troubleshooting...
  • Page 95 If the Patient Test result is Invalid, call Technical Support. Internal Controls Verify that 200 uL of sample was dispensed. Analyzer QC: Review the Rapid fFN 10Q Cassette Kit directional insert to Pass Cassette ensure the correct procedure was followed. Repeat the test QC: Fail on a new cassette.

  • Page 96: Error/Invalid Codes

    Turn analyzer off 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. If analyzer errors persist or recur, call Technical Support. Rapid fFN 10Q System User Manual 7–10 Section 7 — Troubleshooting...
  • Page 97 If Daily QC passes, continue with normal operation. If Daily QC fails, contact Technical Support. Other Codes Call Technical Support. If analyzer errors persist or recur, call Technical Support. Rapid fFN 10Q System User Manual 7–11 Section 7 — Troubleshooting...

  • Page 98: Service And Warranty

    TECHNICAL SUPPORT Analyzer The Rapid fFN 10Q Analyzer is a self-contained instrument. There are no user-serviceable parts. With proper care and use, the analyzer should operate reliably with minimal attention. If a problem should occur, refer to Section 7, Troubleshooting. For analyzer service, call Hologic, Inc. Technical Support.
  • Page 99 0800 183 0227 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 email: intltechsupport@hologic.com Rapid fFN 10Q System User Manual 8–2 Section 8 — Service and Warranty...

  • Page 100: Replacement Parts

    Replacement Parts Item Catalog Number Printer Labels 52660-001 Rapid fFN 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 Customer Service to order replacement parts.
  • Page 101 CUSTOMER SERVICE (Outside the USA and Canada) Please contact your nearest location. To fi nd the nearest location, please visit www.ff ntest.com or www.hologic.com or telephone 00800-800-442-9892 Rapid fFN 10Q System User Manual 8–4 Section 8 — Service and Warranty...
  • Page 102 (1) year from shipment date (except as noted below). During the stated one-year period, Hologic, Inc. shall, at its option, replace with a new unit, reconditioned unit, or repair at no charge a unit that is found to be defective.
  • Page 103 2. Hologic, Inc. reserves the right to make changes in the design of this system without obligation to incorporate such changes into previously manufactured systems. Disclaimer of Warranties THIS WARRANTY IS EXPRESSLY MADE IN LIEU OF ANY AND ALL OTHER WARRANTIES EXPRESS...

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