Page 1 User Manual...
Page 2 0041.21.633.39.10 ©2016 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
Section 1 — Introduction Intended Use General Description Components of the Analyzer Touch screen Cassette insertion site Displayed/Printed Results Specifications Cautions and Warnings Disposal of Electrical & Electronic Equipment 1-10 Symbols Used on the Instrument 1-12 PeriLynx™ System User Manual Table of Contents...
Page 4 TABLE OF CONTENTS Section Page Section 2 — Installation General Environmental Factors Unpacking System Setup Getting Started Setting the Date and Time Factory Default Settings 2-10 Shutdown 2-11 Extended Shutdown 2-11 PeriLynx™ System User Manual Table of Contents...
Page 5 TABLE OF CONTENTS Section Page Section 3 — General Operating/Testing Instructions Starting the System Overview of PeriLynx Analyzer Main Menu Typical Menu Item Sequences Using the Touch Screen Run QCette QC — Quick Reference Test Patient — Quick Reference Enter New Calibration Code — Quick Reference 3-11 Run Liquid QC —...
Page 6 Adjust Settings — QCette Setup 4-35 Adjust Settings — Update Software 4-41 View Reports 4-42 Monthly Usage 4-42 Test Counts 4-44 Access Data 4-45 Access Data — View/Print Data 4-45 Access Data — Data Transfer 4-47 PeriLynx™ System User Manual Table of Contents...
Page 7 Section 5 — Care of the Analyzer Section 6 — Printer Loading Printer Labels Removing an Empty Label Roll Clearing Label Jams Section 7 — Troubleshooting General Information Error/Invalid Codes 7-10 Section 8 — Service Technical Support Replacement Parts PeriLynx™ System User Manual Table of Contents...
Page 8: Section 1 - Introduction
For In Vitro Diagnostic Use Only To be used by trained medical personnel Intended Use The Hologic PeriLynx™ 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 PeriLynx™ QCette for the detection of fetal ®...
Page 9: Components Of The Analyzer
(see Section 5 — Care of the Analyzer). Note: For the detection of fetal fibronectin (fFN) in cervicovaginal secretions, insert a Rapid fFN 10Q Cassette or PeriLynx QCette only. PeriLynx™ System User Manual Section 1 — Introduction...
Page 10: Displayed/Printed Results
Each printed result requires one printer label. Results can be printed from any data record screen either immediately 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 Displayed Printed PeriLynx™ System User Manual Section 1 — Introduction...
Page 11: Specifications
Width — 7.5 inches (19.05 cm) Height — 4 inches (10.16 cm) Weight — 2.4 pounds (1090 g) Operating Temperature 15° to 30°C 59° to 86°F Operating Humidity 20% to 80%, non-condensing PeriLynx™ System User Manual Section 1 — Introduction...
Page 12 56 dB. A.C. Supply 100-240VAC 50-60 Hz 2.1A Input Connector Coaxial power plug with positive center conductor Output Connectors 9-pin RS-232 connector 3 host USB connectors Ethernet connector Printer power connector PeriLynx™ System User Manual Section 1 — Introduction...
Page 13: Cautions And Warnings
Cautions and Warnings There are no known hazards associated with the PeriLynx 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 an AC electrical outlet that provides voltage and current specified by Hologic.
Page 14 Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. PeriLynx™ System User Manual Section 1 — Introduction...
Page 15 The electromagnetic environment should be evaluated prior to operation 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. PeriLynx™ System User Manual Section 1 — Introduction...
Page 16 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 PeriLynx™ System User Manual Section 1 — Introduction...
Page 17: Disposal Of Electrical & Electronic Equipment
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 18 1-888-PRETERM (1-888-773-8376) 1-800-442-9892 1-508-263-2900 Fax: 1-508-263-2967 Authorized Representative in the Hologic Ltd. European Community Heron House, Oaks Business Park Crewe Road, Wythenshawe Manchester, M23 9HZ, UK Tel: +44 (0)161 946 2206 PeriLynx™ System User Manual 1-11 Section 1 — Introduction...
Page 19: Symbols Used On The Instrument
The following symbols may appear on this instrument or its packaging: Caution, consult instructions for Manufacturer Waste Electrical and Electronic Authorized Representative in Equipment - contact Hologic for the European Community disposal of the instrument. 30˚C Store between 15°C and Catalogue Number 15˚C...
Page 20: Section 2 - Installation
• Maximum relative humidity of 80% for temperatures up to 30°C; • Pollution Degree II, in accordance with IEC 61010-1 Category II. The PeriLynx system is for use only in an office or a clean laboratory environment. • The operating temperature should be held relatively constant. The optimum operating temperature is 15° to 30°C (59°...
Page 21: Unpacking
Carefully remove the analyzer and accessories from the shipping carton. Inspect the carton and the analyzer for visible signs of damage. If the analyzer is damaged, immediately contact the carrier and Hologic Customer Service. The carton should contain the following parts/accessories: •...
Page 22 Printer • Printer labels (1 roll) • Power cord • USB cable Note: Retain the shipping carton for future use. If the printer needs to be shipped, use the original shipping carton. PeriLynx™ System User Manual Section 2 — Installation...
Page 23 Barcode scanner (optional) A barcode scanner is available from Hologic for entering data into the analyzer. This barcode scanner is the only barcode scanner for use with the PeriLynx system. If your order included the optional barcode scanner, carefully remove the barcode scanner and accessories from the shipping carton.
Page 24: System Setup
2. Plug the power cable jack into the receptacle labeled 24V DC on the bottom of the printer. Plug the other end of the cable into the PeriLynx analyzer. 3. Insert the USB cable into the receptacle labeled USB on the bottom of the printer. Route the USB cable and the power cable through the cable channel and set the printer upright on a flat surface.
Page 25 4. Use the AC cord corresponding to the room power outlets. Plug the output jack from the power adapter into the rear of the analyzer. Plug the wall mount adapter into an AC power outlet. Caution: Only the power adapter provided with the PeriLynx analyzer may be used. Any substitutions can result in damage to the PeriLynx analyzer and printer.
Page 26: Getting Started
(If the analyzer does not turn on, see Section 7 — Troubleshooting, Item 1.) Upon power up, the analyzer displays the Hologic logo and then PeriLynx system logo with the message “Initializing system...” for 60 seconds. Then, the analyzer performs a self-test of the analyzer components.
Page 27 Once the self-test is complete, the display will change to the Main Menu. The date and time may need to be reset for your time zone. PeriLynx™ System User Manual Section 2 — Installation...
Page 28: Setting The Date And Time
1. From the Main Menu, select Adjust Settings. 2. Touch Date/Time Settings and follow the prompts. For more details about setting the date and time, see Section 4 — Software Functions — Detailed Descriptions. PeriLynx™ System User Manual Section 2 — Installation...
Page 29: Factory Default Settings
Factory Default Settings The PeriLynx 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: Auto Print Factory setting is Auto Print ON. After every result, the printer will generate a printed result.
Page 30: Shutdown
If the system is to be turned off for a long period of time, or taken out of use, power off the analyzer as described above. Completely remove power from the device by unplugging the power cord from the electrical outlet. PeriLynx™ System User Manual 2-11 Section 2 — Installation...
Page 31: Section 3 - General Operating/Testing Instructions
Section 3 — General Operating/Testing Instructions After instrument installation, the PeriLynx 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 the analyzer power switch to the on position. The power switch is located on the back of the instrument.
Page 32: Overview Of Perilynx Analyzer Main Menu
Ensures the analyzer is functioning properly. Performed daily. Run Liquid QC Runs the liquid control samples on the analyzer to ensure the PeriLynx System functions properly. Performed at installation and with every cassette lot change or shipment. View Reports View/print the results of patient tests, QCette and control checks and system calibration results.
Page 33: Typical Menu Item Sequences
Test Patient Run QCette QC QCette Setup View Reports Run Liquid QC Enter New Calibration Code Test Patient Run QCette QC View Reports Run Liquid QC Test Patient View Reports PeriLynx™ System User Manual Section 3 — General Operating/Testing Instructions...
Page 34: Using The Touch Screen
To see an entry that is longer than the ID field area or to edit an entry, touch the ID field area. To edit an entry, use the alphabet, number, or Delete keys. PeriLynx™ System User Manual Section 3 — General Operating/Testing Instructions...
Page 35 The Next button is green only when the analyzer is ready to move to the next part of the sequence. Back button Touch Back to return to the previous screen, unless otherwise specified. PeriLynx™ System User Manual Section 3 — General Operating/Testing Instructions...
Page 36 The analyzer displays an error and beeps if the wrong format is entered or if an invalid code is entered. Press Close to dismiss the error and enter the correct data. PeriLynx™ System User Manual Section 3 — General Operating/Testing Instructions...
Page 37 A Cancel button is available in some cases to stop a sequence and return to the previous screen. Main Menu Touch the Main Menu button to return to the Main Menu. PeriLynx™ System User Manual Section 3 — General Operating/Testing Instructions...
Page 38: Run Qcette Qc - Quick Reference
Enter the QCette ID, or verify, if it is already Results will be displayed and printed in entered. Press Next. Insert QCette and press Next. 3 minutes. If the QCette does not pass, see Section 7 — Troubleshooting, Item 9. PeriLynx™ System User Manual Section 3 — General Operating/Testing Instructions...
Page 39: Test Patient - Quick Reference
Remove the patient cassette from its pouch. The analyzer will check that a Enter the patient accession number and Insert the cassette into the analyzer and Rapid fFN 10Q Cassette is properly press Next. press Next. inserted. PeriLynx™ System User Manual Section 3 — General Operating/Testing Instructions...
Page 40 Add 200 µL of patient sample and press and 2–3 minutes of analysis of the When testing is complete, the system will Start Test. cassette. display and print the result. PeriLynx™ System User Manual 3-10 Section 3 — General Operating/Testing Instructions...
Page 41: Enter New Calibration Code - Quick Reference
Next. Calibration results will be displayed and Enter the Calibration Code (on the cassette can be printed. box) and press Next. Press Finish to return to the Main Menu. PeriLynx™ System User Manual 3-11 Section 3 — General Operating/Testing Instructions...
Page 42: Run Liquid Qc - Quick Reference
Next. Select Level 1 or Level 2 and press Next. Enter the Control Lot number (on bottle label and controls’ box) and press Next. Insert cassette and press Next. PeriLynx™ System User Manual 3-12 Section 3 — General Operating/Testing Instructions...
Page 43 If the liquid control result does not pass, refer to Section 7 — Troubleshooting, Item 10. PeriLynx™ System User Manual 3-13 Section 3 — General Operating/Testing Instructions...
Page 44: Section 4 - Software Functions - Detailed Descriptions
Section 4 — Software Functions — Detailed Descriptions Startup Screen Upon power up, the analyzer displays the Hologic logo and then PeriLynx system logo with the message “Initializing system...” for 60 seconds. Then the analyzer performs a self-test of the analyzer components. This screen also displays the software version.
Page 45: Main Menu
The Main Menu consists of Test Patient, Run QCette QC, Run Liquid QC, View Reports, Enter New Calibration Code, and Adjust Settings. For View Reports and Adjust Settings, selecting the button displays a submenu. PeriLynx™ System User Manual Software Functions — Main Menu Section 4 —...
Page 46: Enter New Calibration Code
The User ID must be entered to proceed to the next step. Press Next to accept the ID. This field will accept 15 alphanumeric characters. PeriLynx™ System User Manual Software Functions — Enter New Calibration Code Section 4 —...
Page 47 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. PeriLynx™ System User Manual Software Functions — Enter New Calibration Code...
Page 48 The complete record will be printed automatically if Auto Print is set to ON, or it may be printed/reprinted by pressing the Print button. Display and Printout PeriLynx™ System User Manual Software Functions — Enter New Calibration Code Section 4 —...
Page 49: Test Patient
Follow the analyzer prompts. The User ID must be entered to proceed to the next step. Press Next to accept the ID. This field will accept 15 alphanumeric characters. PeriLynx™ System User Manual Software Functions — Test Patient Section 4 —...
Page 50 Press Close and the cassette lot number used for calibration will be displayed. Note: If the cassette lot number has changed, Enter New Calibration Code must be performed. PeriLynx™ System User Manual 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 Next. PeriLynx™ System User Manual Software Functions — Test Patient Section 4 —...
Page 52 The analyzer then prompts the user to insert cassette and press Next. The analyzer will check that a Rapid fFN 10Q cassette is properly inserted. PeriLynx™ System User Manual Software Functions — Test Patient Section 4 —...
Page 53 Press Close and remove the incorrect cassette. A 30-second timer starts during which time the analyzer beeps. Add 200 µL of patient sample and immediately press Start Test. PeriLynx™ System User Manual 4-10 Software Functions — Test Patient Section 4 —...
Page 54 Upon completion of the 7-minute 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. PeriLynx™ System User Manual 4-11 Software Functions — Test Patient Section 4 —...
Page 55 This message will hold for 5 seconds and then continues the test. If the test is cancelled, remove the cassette and press Finish. A new cassette will be required to repeat the test. PeriLynx™ System User Manual 4-12 Software Functions — Test Patient Section 4 —...
Page 56 The patient test results are displayed. The complete record will be printed automatically if Auto Print is set to ON, or it may be printed/reprinted by pressing the Print button. Display and Printout Patient results are displayed as the fFN concentration in ng/mL, or INVALID. PeriLynx™ System User Manual 4-13 Software Functions — Test Patient Section 4 —...
Page 57 (1) a threshold level of signal at the procedural control line, (2) proper sample flow across the Rapid fFN 10Q cassette, (3) absence of conjugate aggregation, and (4) proper functioning of the PeriLynx analyzer hardware. PeriLynx™ System User Manual 4-14 Software Functions — Test Patient...
Page 58: Run Qcette Qc
® QCette Setup must be performed. See Adjust Settings — QCette Setup. Refer to the PeriLynx QCette directional insert for more information. Run QCette QC should be performed at least once every 24 hours. Note that Main Menu shows the date and time of the Last QCette QC.
Page 59 QCette setup. Press Close. Either set up a new QCette, or re-do Run QCette QC with the correct QCette. PeriLynx™ System User Manual 4-16 Software Functions — Run QCette QC Section 4 —...
Page 60 Remove cassette and press Next. The analyzer then prompts the user to insert the QCette and press Next. PeriLynx™ System User Manual 4-17 Software Functions — Run QCette QC Section 4 —...
Page 61 This message will hold for 5 seconds and then continues the test. If the test is cancelled, remove the cassette and press Finish test. PeriLynx™ System User Manual 4-18 Software Functions — Run QCette QC Section 4 —...
Page 62 A FAIL result should be repeated. (See Section 7 — Troubleshooting, Items 8 and 9.) Press Finish to return to the Main Menu. Display and Printout PeriLynx™ System User Manual 4-19 Software Functions — Run QCette QC Section 4 —...
Page 63: Liquid Controls
On the Main Menu, select Run Liquid QC to run the liquid controls. The User ID must be entered to proceed to the next step. Press Next to accept the ID. This field will accept 15 alphanumeric characters. PeriLynx™ System User Manual 4-20 Software Functions — Liquid Controls Section 4 —...
Page 64 When this occurs, the display says that the cassette lot has not been calibrated. Press Close and the cassette lot number used for calibration will be displayed. PeriLynx™ System User Manual 4-21 Software Functions — Liquid Controls Section 4 —...
Page 65 Select Level 1 control or Level 2 control. Enter the control lot number and press Next. This field will accept up to 12 alphanumeric characters. PeriLynx™ System User Manual 4-22 Software Functions — Liquid Controls Section 4 —...
Page 66 Remove cassette and press Next. The analyzer then prompts the user to insert the cassette and press Next. PeriLynx™ System User Manual 4-23 Software Functions — Liquid Controls Section 4 —...
Page 67 The analyzer will check that a Rapid fFN 10Q Cassette is properly inserted. A 30-second timer starts during which time the analyzer beeps. Add 200 µL of control sample and immediately press Start Test. PeriLynx™ System User Manual 4-24 Software Functions — Liquid Controls Section 4 —...
Page 68 Upon completion of the 7-minute 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. PeriLynx™ System User Manual 4-25 Software Functions — Liquid Controls Section 4 —...
Page 69 If the test is cancelled, remove the cassette and press Finish test. If the test is cancelled, a new cassette will be required to repeat the test. PeriLynx™ System User Manual 4-26 Software Functions — Liquid Controls...
Page 70 Kit directional insert for acceptable results for the liquid controls. An out-of-range result or an INVALID result should be repeated. (See Section 7 — Troubleshooting, Items 10 and 11.) Display and Printout PeriLynx™ System User Manual 4-27 Software Functions — Liquid Controls Section 4 —...
Page 71: Adjust Settings
Date/Time, adjust the Sound Settings, Auto Print, change the Password Settings or to perform QCette Setup. This option also allows Hologic Technical Support to update the software version. Press the Adjust Settings button on the Main Menu to access the Adjust Settings screen.
Page 72 Or, press the Back button to to save changes or No to discard the check mark indicates the selection. Press the Save button to accept. return to the Adjust Settings screen. changes. PeriLynx™ System User Manual 4-29 Software Functions — Adjust Settings Section 4 —...
Page 73: Adjust Settings - Sound Settings
Press the Back button to return to the Adjust Settings screen. PeriLynx™ System User Manual 4-30 Software Functions — Adjust Settings...
Page 74: Adjust Settings - Auto Print
Auto Print automatically prints test results when set in the ON position. When Auto Print is OFF, results may be printed by pressing the Print button. Auto Print ON Auto Print OFF PeriLynx™ System User Manual 4-31 Software Functions — Adjust Settings Section 4 —...
Page 75: Adjust Settings - Password Settings
If the password protection is disabled, the Access Data features are available to all users. If the password protection is disabled, to enable the password protection, touch the Enter New Password button. PeriLynx™ System User Manual 4-32 Software Functions — Adjust Settings Section 4 —...
Page 76 Use the touch screen or the optional barcode scanner to enter the current password. Press the Next button, and then enter the new password. Press the Save button. PeriLynx™ System User Manual 4-33 Software Functions — Adjust Settings Section 4 —...
Page 77 Press the Next button. The password protection changes from “Enabled” to “Disabled”. No password is required to view or print the information in the Access Data section. PeriLynx™ System User Manual 4-34 Software Functions — Adjust Settings Section 4 —...
Page 78: Adjust Settings - Qcette Setup
Select QCette Setup on the Adjust Settings menu to begin. Enter the User ID to proceed to the next step. Press Next to accept the ID. This field will accept 15 alpha and/or numeric characters. PeriLynx™ System User Manual 4-35 Software Functions — Adjust Settings Section 4 —...
Page 79 This message will be displayed if a cassette is present in the analyzer prior to reaching the next screen. Remove cassette and press Next. PeriLynx™ System User Manual 4-36 Software Functions — Adjust Settings Section 4 —...
Page 80 The analyzer will begin initializing the QCette. Do not disturb the analyzer until the results are displayed. The initialization process will take approximately 10 minutes. Initialization can be terminated by pressing Cancel. PeriLynx™ System User Manual 4-37 Software Functions — Adjust Settings Section 4 —...
Page 81 Select Yes to stop processing or No to continue the test. This message will hold for 5 seconds and then continues the test. If the test is cancelled, remove the cassette and press Finish test. PeriLynx™ System User Manual 4-38 Software Functions — Adjust Settings Section 4 —...
Page 82 Upon successful completion of the QCette Setup, this message will be displayed. SETUP COMPLETE indicates that the performance criteria of the analyzer have been established. Press Finish to return to the Main Menu. Display and Printout PeriLynx™ System User Manual 4-39 Software Functions — Adjust Settings...
Page 83 It indicates that the performance criteria of the analyzer have not been established. If the QCette setup error occurs, see Section 7 — Troubleshooting, Item 8. PeriLynx™ System User Manual 4-40 Software Functions — Adjust Settings Section 4 —...
Page 84: Adjust Settings - Update Software
Adjust Settings — Update Software The Adjust Settings screen has an option which allows the software version to be updated. PeriLynx™ System User Manual 4-41 Software Functions — Adjust Settings Section 4 —...
Page 85: View Reports
USB drive to any USB port on the back of the analyzer before you touch the Monthly Usage button on the View Reports screen. PeriLynx™ System User Manual 4-42 Software Functions — View Reports Section 4 —...
Page 86 Print the report by pressing the Print button. Press the Back button to return to the View Reports screen. Press the Main Menu button to return to the Main Menu. Display and Printout PeriLynx™ System User Manual 4-43 Software Functions — Monthly Usage Section 4 —...
Page 87: Test Counts
Press the Print button to print Test Counts Report (TCR). Press the Back button to return to the View Reports screen. Press the Main Menu button to return to the Main Menu. Display and Printout PeriLynx™ System User Manual 4-44 Software Functions — Test Counts Section 4 —...
Page 88: Access Data
QCette QC data, Liquid QC data or Calibration data stored in the analyzer. Select the category of data records to view and/or print. PeriLynx™ System User Manual 4-45 Software Functions — Access Data Section 4 —...
Page 89 Patient data was chosen for this example. Use the up or down arrow to scroll through the summaries. PeriLynx™ System User Manual 4-46 Software Functions — Access Data Section 4 —...
Page 90: Access Data - Data Transfer
Note: A maximum of 1000 patient test results, 50 QCette QC results, 50 Liquid QC results, and 50 Calibration results are stored on the analyzer. PeriLynx™ System User Manual 4-47 Software Functions — Access Data Section 4 —...
Page 91 Data transferred to a computer is in ASCII format. Capture and organization of the transferred data is done at the discretion of the user. Hologic, Inc. DOES NOT provide software or technical support relating to the manipulation of data once it has left the analyzer.
Page 92: Section 5 - Care Of The Analyzer
The following cleaning agents may be applied with a cloth or lab wiper only. NEVER apply agents by spray. • 70% ethanol • General laboratory cleaning detergent with disinfectant properties PeriLynx™ System User Manual Section 5 — Care of the Anaylzer...
Page 93: Section 6 - Printer
Section 6 — Printer Loading Printer Labels Refer to Section 2 — Installation, for instructions on connecting the printer to the PeriLynx analyzer. Note: DO NOT install any of the Dymo Label software that is packaged with the printer. 1. Open the printer cover for access to the interior of the printer. Remove any packing material.
Page 94 Figure 2. (If it is easier, rest the labels on the top edge of the printer, freeing both hands to feed the labels.) PeriLynx™ System User Manual Section 6 — Printer...
Page 95 9. Insert the label spool into the printer. The spool will fit into the raised shoulder slots in the printer. 10. Close the cover and the printer is ready to print labels. PeriLynx™ System User Manual Section 6 — Printer...
Page 96: 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). PeriLynx™ System User Manual Section 6 — Printer...
Page 97: 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. PeriLynx™ System User Manual Section 6 — Printer...
Page 98 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. PeriLynx™ System User Manual Section 6 — Printer...
Page 99: Section 7 - Troubleshooting
Section 7 — Troubleshooting General Information The PeriLynx 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. Call Hologic Technical Support for any questions related to the performance of your PeriLynx system.
Page 100 Turn off the analyzer. characters appear on Reconnect the printer power cord to the analyzer. display screen, and the Turn on the analyzer. analyzer does not respond to Proceed with testing. touch screen selections. PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 101 Recall the test result on the analyzer display screen test was run. (View Reports, Access Data, Patient. Select the report from the list to open it). Press Print on the analyzer to print the result. PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 102 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.) PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 103 Functions — Detailed Descriptions. If QCette setup is complete, run QCette QC, followed by Run Liquid QC. Do not bump or jar analyzer or QCette during the test. If the QCette setup fails a second time, call Technical Support. PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 104 When QCette Setup is complete, Run QCette QC, followed by Run Liquid QC. If both pass, no further troubleshooting is required. If Run QCette QC fails a second time, call Technical Support. PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 105 Repeat the test on a new cassette. If control result is acceptable, no further troubleshooting is required. If the control result is outside the range of acceptable results a second time, call Technical Support. PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 106 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. PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 107 (lubricants, soap, disinfectant, creams). Retest the sample on a new cassette. If the problem is not corrected, contact the physician and recommend recollection in 24 hours. PeriLynx™ System User Manual Section 7 — Troubleshooting...
Page 108: Error/Invalid Codes
0721 Rerun Run QCette QC. If Run QCette QC passes, continue with normal operation. If Run QCette QC fails, contact Technical Support. If analyzer errors persist or recur, call Technical Support. PeriLynx™ System User Manual 7-10 Section 7 — Troubleshooting...
Page 109 If Run QCette QC passes, continue with normal operation. If Run QCette QC fails, contact Technical Support. Other Codes Call Technical Support. If analyzer errors persist or recur, call Technical Support. PeriLynx™ System User Manual 7-11 Section 7 — Troubleshooting...
Page 110: Section 8 - Service
Technical Support Analyzer The PeriLynx 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, contact Hologic Technical Support.
Page 111: Contact Information
0800 114829 Sweden: 020 797943 France: 0800 913659 Switzerland: 0800 298921 Germany: 0800 1830227 0800 0323318 Ireland (Rep): 1 800 554144 Other countries: 00800.800.29892 Italy: 800 786308 Intl Fax number: 0041.21.633.39.10 email: intltechsupport@hologic.com PeriLynx™ System User Manual Section 8 — Service...
Page 112: Replacement Parts
Specimen Collection Kit PRD-01020 Rapid fFN Cassettes, 26-pack box PRD-01018 Barcode scanner MEL-00970 PeriLynx System User Manual MAN-04720-001 Contact fFN Customer Service to order replacement parts. Contact Information Customer Service (USA/Canada only) Customer Service (Outside the USA and Canada) Tel: 1-888-PRETERM (1-888-773-8376) Please contact your nearest location.
Page 113 A copy of Hologic’s limited warranty and other terms and conditions of sale may be obtained by contacting Customer Service at the numbers listed above. PeriLynx™ System Analyzer Serial Number _______________________________________ Printer Serial Number _________________________________________ Barcode Scanner Serial Number (optional) ______________________ Shipment Date _______________________________________________ PeriLynx™...

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