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Qualigen FastPack IP System Procedures Manual

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PROCEDURE
MANUAL

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Justine Williams
May 7, 2025

I recieved a message that said "Temp Invalid Test" What does that mean?

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1 comments:
Mr. Anderson
May 18, 2025

"Temp Invalid Test" means the temperature has exceeded the correct range during a test. The pack used should be discarded, and the test should be retried. If the problem continues, contact System Support.

This answer is automatically generated

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Kim Oregon
April 16, 2025

Qualigen machine states 0.00 time remaining

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Summary of Contents for Qualigen FastPack IP System

  • Page 1 PROCEDURE MANUAL...

  • Page 3: Table Of Contents

    Table of Contents FastSteps ................................v FastSteps for Vitamin D ............................vii Welcome ................................1 What the FastPack IP System Does ......................1 ® About This Manual ............................1 Safety Features ..............................2 Electrical ................................ 2 Nemko Mark Label ..........................2 Other Symbols...............................
  • Page 4 Sample Dilution - hCG ............................29 When to Dilute a Test Sample ........................29 What You Need ............................29 Diluting a Sample ............................30 Setting Dilution Mode ..........................31 Dilution Mode ........................... 31 Enable Dilution Mode - hCG ........................31 Disable Dilution Mode - hCG .........................
  • Page 5 Warranty (For U.S. Only) ........................... 73 Support / Services / Supplies ........................73 Manufactured By: ............................74 Notes: ................................... 75 65000159 Rev. 008 (06/17)
  • Page 6 65000159 Rev. 008 (06/17)

  • Page 7: Faststeps

    FastSteps 65000159 Rev. 008 (06/17)
  • Page 8 65000159 Rev. 008 (06/17)

  • Page 9: Faststeps For Vitamin D

    FastSteps for Vitamin D 65000159 Rev. 008 (06/17)
  • Page 10 viii 65000159 Rev. 008 (06/17)

  • Page 11: Welcome

    For information on the performance of FastPack IP tests, please refer to the current direction insert ® posted on the Qualigen, Inc. website at www.qualigeninc.com. If you have questions or concerns about the FastPack IP System, please contact your local distributor or ®...

  • Page 12: Safety Features

    Safety Features Electrical The FastPack IP Analyzer must be connected to a properly grounded outlet. ® Nemko Mark Label The application of the Nemko mark denotes that the FastPack IP System meets ® all requirements for electrical safety and is approved for use in the field. Other Symbols All symbols discussed on this page can be found on the inside door plate of the FastPack IP Analyzer.

  • Page 13: Setting Up The Fastpack ® Ip System

    Setting Up the FastPack IP System ® What is Included 1. FastPack IP Analyzer ® 2. External Printer ① ② 3. AC Power Cords (2) 4. Desktop Power Supply (2) 5. Procedure Manual QA Manual (US Only) QA Log (US Only) ④...

  • Page 14: Getting Power To The Fastpack

    FastPack IP System Set Up ® ® Getting Power to the FastPack IP System Action Instrument Information Illustration Plug Desktop Power Supply into the analyzer. Plug AC Power Cord into Desktop Power Supply. Turning ON the System Analyzer Plug AC Power Cord into the wall socket.

  • Page 15: Set Up Menu

    ® FastPack IP System Set Up Set Up Menu Action Instrument Information Illustration Enter the Set Up Menu for This mode is not accessible the analyzer by pressing when a test is in progress. the RED button. Language Units Scroll to “Languages Units” “Languages by pressing the RED Units”...

  • Page 16: Setting Date And Time

    FastPack IP System Set Up Action Instrument Information Illustration Testosterone units will Select your language by display as “ng/dL” when pressing the BLUE button. English 1 is selected. Setting Date and Time Scroll to “Date/Time” by “Date/Time” pressing the RED button.

  • Page 17: Setting Analyzer For External Printer Use

    FastPack IP System Set Up Action Instrument Information Illustration If date is incorrect, press RED button to change this date. Scroll to the correct date “mm/dd/yy and time digit with the RED hh:mm *M” button. If English 2 or a European...

  • Page 18: Connecting The External Printer

    FastPack IP System Set Up ® Action Instrument Information Illustration Press the BLUE button to select the “Set to Printer” “Set to Printer” menu option. Scroll to “Exit” by pressing “Exit” the RED button. Select “EXIT” by pressing the BLUE button. Connecting the External Printer Further instruction and illustration can be found in...
  • Page 19 FastPack IP System Set Up ® Action Instrument Information Illustration Connect the large end of the Serial Printer Cable to Analyzer should be turned the rear of the external on and in “Ready” position. printer with a screwdriver, or tighten screws by hand. Connect the other end of the Serial Printer Cable to the analyzer at the port...
  • Page 20 FastPack IP System Set Up ® Action Instrument Information Illustration Remove the printer cover. Follow all instructions Unwrap and insert the found in the printer printer ribbon cartridge manual. into the printer. You are now ready to calibrate the analyzer! You can only run a FastPack ®...

  • Page 21: Calibrating The Fastpack Ip System

    Calibration Card b. Vial of Calibrator (1) 4. Pipette * Use 25 µL pipette for hCG. 5. Pipette Tips (available from Qualigen) 6. Medical Gloves – used to avoid contact with ② ③ biohazard materials such as human blood, etc.

  • Page 22: Calibration Procedure

    Calibration Procedure Action Instrument Information Illustration Open the FastPack ® Be sure to refer to the Calibration Kit. Remove Direction Insert for the test contents. type being calibrated. Calibration Kit Lot Number Expiration Date Important quality control information is now included in your Quality Assurance Log.
  • Page 23 Calibration Procedure Action Instrument Information Illustration Open the analyzer door. Remove the calibration “Insert Cal card. Press Start” Store card in Calibration Kit. Always keep FastPack ® stored in the refrigerator, Remove the FastPack ® in the position indicated on from its box.

  • Page 24: Fastpack ® Ip Vitamin D Users Only! - Sample Pretreatment

    Calibration Procedure Action Instrument Information Illustration Use only Qualigen recommended pipette tips. The tips are available through your local distributor or Qualigen. Be sure that the pipette Closely follow FastSteps 2 operates smoothly and through 5 from your does not stick.
  • Page 25 Calibration Procedure Calibration Procedure - Continued Action Instrument Information Illustration Open analyzer door. Place ® FastPack IP on the door. It is only possible to align “Insert Cal ® Align the pins on the door the FastPack IP in one Press Start”...
  • Page 26 Calibration Procedure Action Instrument Information Illustration When calibration is complete, analyzer will beep. “Cal X Pass 10/05/16 11:00” “Cal X Fail The result will remain 10/05/16 11:00” The display will confirm displayed for one minute whether calibration passed after the door is opened. or failed, and display date “Cal Fail See Troubleshooting if...
  • Page 27 Calibration Procedure Action Instrument Information Illustration Printer will print and ® ® Slip the FastPack IP into release the FastPack the external printer from automatically. the left side with the label It is important to insert the side up and the label facing FastPack ®...
  • Page 28 “PASS” Order a new Calibration Kit for a successful calibration. from your local distributor See the Calibration Process or Qualigen, Inc. Tree on Page 20 which illustrates the messages shown on the analyzer display. See Direction Insert for the test being calibrated.

  • Page 29: A Word About Calibration

    A Word about Calibration Purpose The purpose of this section is to concisely define how and when calibrators are run for the various assays used in the FastPack IP System. ® General Procedure The calibration kit contains a calibration card and 1 vial of calibrator. The calibration card is used to communicate to the analyzer that the next test run will be a calibration.

  • Page 30: Fastpack ® Ip System Analyzer Calibration Process Tree

    ® FastPack IP System Analyzer Calibration Process Tree Calibration Pass Display Cal X Pass Cal Complete Calibration Pass Calibration Pass Display Display Cal X Pass Cal X Pass Run Another Cal Cal Complete Calibration Fail Display Cal X Fail Run Another Cal Calibration Fail Display Cal X Fail...

  • Page 31: Control Testing

    Control testing ensures that you are running the test correctly and that your FastPack IP System is ® working properly. When control testing is performed, two control levels must be used. Qualigen recommends that users run controls whenever: Patient testing is performed.* ...

  • Page 32: Control Testing Procedure

    FOR FASTPACK IP VITAMIN D USERS ONLY ® 8. Pretreatment Buffer ⑧ Control Testing Procedure Action Instrument Information Illustration Keep the Control Range ® Open the FastPack Card in a place easily Control Kit. Remove retrieved for reference; contents. possibly in your Quality Assurance Log.

  • Page 33: Fastpack ® Ip Vitamin D Users Only! - Sample Pretreatment

    Control Testing Procedure Action Instrument Information Illustration Utilize only Qualigen recommended pipette tips. The tips are available through your local distributor or Qualigen. Be sure that the pipette Closely follow FastSteps 2 operates smoothly and through 5 from your does not stick.
  • Page 34 Control Testing Procedure Action Instrument Information Illustration Invert the buffer tube at least 3 times to thoroughly mix together the sample and buffer. The act of mixing the sample and buffer releases the vitamin D present, therefore making it available for the assay.
  • Page 35 Control Testing Procedure Action Instrument Information Illustration “Processing The screen will display test status and time remaining. XX remaining” When test is complete, analyzer will beep. The analyzer will provide the test result on the Example: display. The result will remain “2.1 ng/mL displayed for one minute 06/21/16 1:00PM”...
  • Page 36 Control Testing Procedure Action Instrument Information Illustration Remove and inspect the Ensure that all chambers FastPack ® IP. Check the have burst. Fluid should inside of the Analyzer door easily flow between all for fluid. If there is fluid on chambers.
  • Page 37 If the retest is still outside of the If each of these lot acceptable range, call numbers match, then Qualigen System Support verify that the result at 877-770-6127. Result printed on the FastPack ® must be...
  • Page 38 65000159 Rev. 008 (06/17)

  • Page 39: Sample Dilution - Hcg

    Sample Dilution - hCG When to Dilute a Test Sample Samples can be accurately measured for hCG if it is within the analytic range of 1. 8 – 1000 mIU/mL. However, in some instances, the analyte level in patient samples may exceed the assay range of 1000 mIU/mL.

  • Page 40: Diluting A Sample

    Diluting a Sample Action Instrument Information Illustration It is IMPORTANT to use a Using a NEW pipette tip, new unused pipette tip in draw a fresh 25 µL patient order to create an accurate sample dilution. Add this sample to a Sample Diluent tube.

  • Page 41: Setting Dilution Mode

    Diluting a Sample Action Instrument Information Illustration This is now your 1:100 diluted patient sample that you will run through the FastPack® IP System Place this sample into a analyzer. fresh FastPack® IP. To create a 1:10,000 diluted sample, repeat the above steps using your 1:100 diluted sample as your patient sample.

  • Page 42: Disable Dilution Mode - Hcg

    Setting Dilution Mode Enable Dilution Mode – hCG - Continued Action Instrument Information Illustration Press the BLUE button to This action enables the “Ask Dilution is ON” accept. Dilution Mode. The analyzer display will “Ready” return to the “Ready” screen Disable Dilution Mode - hCG Press RED button several times to scroll through the...

  • Page 43: Testing With The Fastpack ® Ip System In Dilution Mode

    Setting Dilution Mode Action Instrument Information Illustration The analyzer display will “Ready” return to the “Ready” screen Testing with the FastPack IP System in Dilution Mode ® Testing in Dilution Mode Testing a Neat Sample in Dilution Mode Action Instrument Information Illustration Insert the sample filled...

  • Page 44: Testing An Hcg 1/100 Diluted Sample In Dilution Mode

    Testing in Dilution Mode Testing a Neat Sample in Dilution Mode - Continued Action Instrument Information Illustration This prompt is asking for “NO Dilution Used Press the BLUE button. confirmation that you are Red=STOP, Blue=GO” testing a neat sample. “Processing… The test is initiated.

  • Page 45: Testing An Hcg 1/10000 Diluted Sample In Dilution Mode

    Testing in Dilution Mode Testing an hCG 1/100 Diluted Sample in Dilution Mode - Continued Action Instrument Information Illustration This prompt is asking for “Red=1/ 100 Press the RED button. the dilution factor of the Blue=1/10000.0” sample. “Dil=1/ 100 This prompt is asking for Press the RED button.
  • Page 46 Testing in Dilution Mode Testing an hCG 1/10000 Diluted Sample in Dilution Mode - Continued Action Instrument Information Illustration This prompt is questioning whether or not the current test sample is diluted. “Sample Dilution? Press the BLUE button. To test a diluted sample, Red=Yes, Blue=No”...

  • Page 47: Who International Standard

    WHO International Standard The World Health Organization (WHO) has established International Biological Reference Preparations to serve as reference sources for defining biological activity expressed in an internationally agreed upon unit of measure. The FastPack IP System provides the user the option 0f displaying results for Total PSA ®...

  • Page 48: Disable Who Unit Mode - Total Psa

    Disable WHO Unit Mode – Total PSA WHO Unit Mode Action Instrument Information Illustration Press the RED button several times until the display reads “Set WHO unit OFF”. This action disables the Press the BLUE button. “WHO unit are OFF” WHO unit MODE.

  • Page 49: Sample Collection And Delivery Into The Fastpack Ip

    Sample Collection and Delivery into the FastPack ® What You Need 1. Pipette * Use 25 µL pipette for hCG. 2. Pipette Tips 3. Sample (patient plasma or serum, calibrator or ① ② control) 4. FastPack ® 5. Microcentrifuge (required for patient samples only) 6.

  • Page 50: Sample Collection And Delivery

    Use only Qualigen recommended pipette tips. The tips are available through your local distributor or Qualigen. Be sure that the pipette Closely follow FastSteps 2 operates smoothly and through 5 from your does not stick. It is very FastSteps Guide.
  • Page 51 Sample Collection and Delivery Action Instrument Information Illustration Use serum, plasma, calibrators or controls only. Always wear gloves when handling samples. Closely follow FastSteps 6 It is very important that through 10 from your the pipette tip is firmly FastSteps Guide. placed in the injection port.
  • Page 52 65000159 Rev. 008 (06/17)

  • Page 53: Sample Collection And Delivery Into The Fastpack Ip (Vitamin D Testing Only)

    Sample Collection and Delivery into the FastPack ® (Vitamin D Testing Only) What You Need 1. Pipette (available from Qualigen) 2. Pipette Tips (available from Qualigen) 3. Sample (patient plasma or serum, calibrator or control) 4. FastPack Pretreatment Buffer ①...

  • Page 54: Sample Collection And Delivery - Vitamin D Only

    Use only Qualigen recommended pipette tips. The tips are available through your local distributor or Qualigen. Be sure that the pipette Closely follow FastSteps 2 operates smoothly and through 5 from your does not stick. It is very...
  • Page 55 Sample Collection and Delivery – Vitamin D Only Action Instrument Information Illustration When testing for Vitamin D, it is necessary to treat Follow steps 6 through 9 each sample with pre- from your FastSteps for treatment buffer prior to Vitamin D Guide. putting the sample into the ®...
  • Page 56 65000159 Rev. 008 (06/17)

  • Page 57: Running Patient Samples

    3. FastPack IP (for the specific assay to be tested) 4. Pipette (available from Qualigen) ① 5. Pipette Tips (available from Qualigen) 6. Patient Sample (serum or plasma depending on the assay) 7. Medical Gloves - used to avoid contact with biohazard materials such as human blood, etc.

  • Page 58: Fastpack ® Ip System Procedure

    Name/ID # and the important for quality operator’s initials on the control. ® peel-off FastPack IP label. Use only Qualigen recommended pipette tips. The tips are available through your local distributor or Qualigen. Be sure that the pipette Closely follow FastSteps 2...
  • Page 59 FastPack IP System Procedure ® Action Instrument Information Illustration Use serum, plasma, calibrators or controls only. Always wear gloves when handling samples. Closely follow FastSteps 6 It is very important that through 10 from your the pipette tip is firmly FastSteps Guide.
  • Page 60 FastPack IP System Procedure ® Running Patient Samples - Continued Action Instrument Information Illustration ® Open the FastPack analyzer door. Place FastPack ® IP on the It is only possible to align door. Align the pins on the the FastPack ®...
  • Page 61 FastPack IP System Procedure ® Action Instrument Information Illustration The screen will display test status and time remaining. “Processing Press the Cancel button if XX min. remain” test needs to be stopped in an emergency. When test is complete, analyzer will beep. The result will remain Example: displayed for one minute...
  • Page 62 FastPack IP System Procedure ® Action Instrument Information Illustration Remove and inspect the Confirm that all chambers FastPack ® IP. Check the have burst. Fluid should inside of the analyzer door easily flow between all for fluid. If there is fluid on chambers.
  • Page 63 FastPack IP System Procedure ® Action Instrument Information Illustration Peel off the label and place it in the patient record. ® Discard the FastPack into a Biohazard container. 65000159 Rev. 008 (06/17)
  • Page 64 65000159 Rev. 008 (06/17)

  • Page 65: Cleaning The Fastpack Ip System

    Cleaning the FastPack IP System ® Note: Always wear protective gloves when cleaning or disinfecting the analyzer. The FastPack IP System analyzer is completely self- ® enclosed, and only requires periodic cleaning to remove excess sample. Use a damp cloth to wipe down the entire exterior and interior compartment of the analyzer.
  • Page 66 65000159 Rev. 008 (06/17)

  • Page 67: Troubleshooting

    IP System analyzer will sound with a ® beep each time an error message is displayed If a problem persists, please contact your local distributor or call Qualigen, Inc. System Support at 877- 770-6127; or e-mail System Support at systemsupport@qualigeninc.com. Display...
  • Page 68 Troubleshooting the FastPack IP System ® Display Cause Action Verify that edges of silicone shield are Silicone shield incorrectly installed flush with back plate ® ® FastPack IP or card has slipped off Verify that FastPack IP or card is “Door Failure”...
  • Page 69 Troubleshooting the FastPack IP System ® Display Cause Action Ensure that the analyzer is not in direct PMT Failure; Light Leak. “PMT Failure” sunlight. Contact System Support. Shutter Failure Contact System Support. “Shutter Failure” System has a severe pressure leak. Air Contact System Support.
  • Page 70 Out of Range” • See section titled Troubleshooting (One high and the other low) FastPack ® IP Injection Port and Pipette. Delayed Delivery Contact Qualigen System Support ® Unrefrigerated FastPacks Refrigerator Malfunction Contact Qualigen System Support 65000159 Rev. 008 (06/17)
  • Page 71 Troubleshooting the FastPack IP Injection Port and Pipette ® Important Note Proper performance of the pipette is critical to obtain accurate test results. If at any time, you note the pipette plunger sticking, or if plunger operation feels rough, replace with a new pipette. Problem Cause Action...

  • Page 72: Analyzer Software Upgrade

    Analyzer Software Upgrade Check the back of your FastPack analyzer to determine if it is equipped with a Smart Media Card slot or a USB port. Follow the appropriate Software Upgrade Procedure that corresponds with your specific FastPack Analyzer. 65000159 Rev. 008 (06/17)

  • Page 73: Analyzer Software Upgrade Using Smart Media Card

    2 minutes. If the Press the BLUE button to analyzer should get stuck select the “Upgrade “Checking…” at any step, call Qualigen Software” menu option. System Support. If an error message is displayed, DO NOT turn off the machine. Follow the instructions on the display.
  • Page 74 Upgrade Procedure Action Instrument Information Illustration After the software is completely installed, When the analyzer returns “Software VX.XX” appears to “Ready” mode, press in the display and the self- the EJECT button next to diagnostics will run the port and remove the “Ready”...

  • Page 75: Analyzer Software Upgrade Using Usb

    Analyzer Software Upgrade Using USB Power off the analyzer Insert USB drive into the USB port in back of the analyzer Power on the analyzer. The screen will be blank for about 15 seconds. The newly installed software version number will then appear for 2 seconds.
  • Page 76 If software was loaded Continue pressing the red button until you reach “Exit” then press the successfully… blue button. The screen will display “Ready”. Power off analyzer. Remove USB stick. Power on the analyzer. Analyzer will proceed through self- diagnostics, then screen will display”Ready”...

  • Page 77: Calibration Reset

    Calibration Reset Calibration Reset Procedure Action Instrument Information Illustration “Ready” Place the Calibrator Card, for the test type calibration you want to erase, on the door. Align “Ready” the pins on the door with the holes in the Calibration Card. Close the analyzer door.
  • Page 78 Calibration Reset Procedure Action Instrument Information Illustration Press and hold the RED Analyzer will beep four button times. If you do not want to erase the calibration press the Example: RED button, again. Release the RED button “Erase After “Erase tPSA Cal” is when the beeping stops.

  • Page 79: Downloading Data

    IP System (when COM1 is configured for a computer) allows for the output of test results to ® a personal computer (PC). The computer can be connected using a serial cable Qualigen Part Number 15000112. The cable connects to the RJ-45 jack on the rear panel of the FastPack Analyzer and terminates with a female DB-9 connector compatible with input to a PC serial port.
  • Page 80 USB Port Equipped Model The USB port in the back of the analyzer is an input dedicated specifically for analyzer software upgrades. COM 1 is an output port dedicated for printer output using an RS 232 connection. Output to printer may be turned on or off in the analyzer menu by toggling the option between "Set Printer ON"...

  • Page 81: Fastpack ® Ip System Product Specifications

    FastPack IP System Product Specifications ® FastPack IP System Analyzer ® Ambient Operating Temperature: 15 °C (59 °F) to 32 °C (90 °F) Operating Humidity: 10% to 80% relative humidity Operating Altitude: ≤ 2000 m (6562 ft.) Pollution Degree: Installation Category: Display Output: 2 line alphanumerical display Data Output...

  • Page 82: Storage Conditions

    *IEC 100-4-4 and IEC 1000-4-6 were passed under criterion C. Disposal This product contains recyclable materials. Do not dispose of this product as unsorted waste. Please contact your local dealer or Qualigen, Inc. for disposal instructions. Principle of Operation Sample is added to the FastPack via the injection port.

  • Page 83: Limitation Of Procedure

    Qualigen’s liability for all matters arising under this warranty shall be limited solely to the repair or (in Qualigen’s sole discretion) replacement of the product. If Qualigen reasonably determines that a repair or replacement is covered by this warranty, Qualigen shall bear the cost of shipping the repaired or replacement product to the customer.

  • Page 84: Manufactured By

    Manufactured By: Qualigen, Inc. 2042 Corte del Nogal, Carlsbad, CA 92011 (0) 1-760-918-9165 (PH)  (0) 1-760-918-9127 (FX) Toll Free: 1-877-709-2169 www.qualigeninc.com systemsupport@qualigeninc.com 65000159 Rev. 008 (06/17)

  • Page 85: Notes

    Notes: 65000159 Rev. 008 (06/17)
  • Page 87 2042 Corte del Nogal, Suite B Carlsbad, CA 92011 PH: (877) 709-2169; (760) 918-9165  FX: (760) 918-9127 www.qualigeninc.com...

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