Alere Cholestech LDX System User Manual
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Alere Cholestech LDX System User Manual

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  • Page 1 ® Cholestech LDX System User Manual...
  • Page 3 Cholestech LDX System User Manual Read Me First ® Congratulations on the purchase of your Alere Cholestech LDX System. Please take a few minutes to examine the contents of your package to be sure that nothing has been damaged in shipment.

  • Page 4: Table Of Contents

    Table of Contents Introduction ..............4 Examining Your Package Contents ..........5 ® How the Alere Cholestech LDX Analyzer Works ......6 Getting Started ..............10 Setting the Configuration Menu ..........12 Configuration Menu Flowchart ..........14 ® Alere Cholestech LDX Optics Check ........16 Optics Check Cassette Test Procedure ........
  • Page 5 Troubleshooting & Maintenance ........35 Cleaning ..................35 Precautions and Warnings ............36 Corrective Action ............... 37 Limited Warranty ............41 General Specifications ...........42 Glossary of Terms ............43 Contact Alere ..............44 Symbols .................45 ® Alere Cholestech LDX System User Manual...

  • Page 6: Introduction

    Analyzer. Please read this entire manual before you use the analyzer. Alere™ Product Support and Customer Service Alere will provide every customer with the product support and training needed to properly use the Alere Cholestech ® System. We maintain a staff of qualified Product Support Specialists available 24 hours a day, seven days a week.

  • Page 7: Examining Your Package Contents

    (The carrying case is not intended for shipping the Alere ® Cholestech LDX Analyzer.) In addition to these supplies, you may need the following ® materials that are not provided with your Alere Cholestech LDX System: ® • Alere Cholestech LDX Test Cassettes •...

  • Page 8: How The Alere Cholestech Ldx Analyzer Works

    ® How the Alere Cholestech LDX Analyzer Works ® The Alere Cholestech LDX Analyzer uses reflectance photometry (the amount of light reflected from a solid surface) to measure the amount of substances in blood. The analyzer measures color changes of the four reagent pads. The amount of color formed is converted by the analyzer to a concentration and the results are shown on the liquid crystal display (LCD) screen.
  • Page 9 1. Stops a test. 2. Closes the drawer. 3. Allows you to enter and exit the Configuration Menu of the analyzer. The drawer will close and the screen will go blank after four minutes without use. ® Alere Cholestech LDX System User Manual...
  • Page 10 9 volts DC at 1 amp. A country-specific power supply is included. ® NOTE: The Alere Cholestech LDX Analyzer contains a battery that cannot be replaced by the user. Battery life is greatly reduced if the analyzer is left unplugged. To conserve this battery, we recommend plugging in the analyzer when not in use.
  • Page 11 Reaction Bar Sample Well Main Body Magnetic Stripe ® Alere Cholestech LDX System User Manual...

  • Page 12: Getting Started

    Testing memory Selftest running Selftest OK For Multi-Languages Only. ® NOTE: The translations that show on the Alere Cholestech LDX Analyzer screen do not include the language accents due to ® hardware limitations of the Alere Cholestech LDX Analyzer’s display.
  • Page 13 If these messages still do not appear, or if the screen reads: Calibration Fail ...Call Tech Serv Contact Alere. If the analyzer is not yet at the proper operating temperature (warmed up), the screen will display: Initial Warm-Up ********** ® Alere Cholestech LDX System User Manual...

  • Page 14: Setting The Configuration Menu

    Setting the Configuration Menu ® Before using your Alere Cholestech LDX Analyzer, you should enter the Configuration Menu and set it to best meet your needs. The following items can be customized: Language English, Italian, Spanish, German, French Units mg/dL= milligrams per deciliter...
  • Page 15 If you wish to change the units displayed, press the DATA button to change to: Config menu UNITS=mmo1/L When the desired choice is displayed, press the RUN button to enter the choice and to advance to the next item. ® Alere Cholestech LDX System User Manual...

  • Page 16: Configuration Menu Flowchart

    – Yes = reports LDL/HDL ratio Press RUN to continue. Press DATA to select PRINTER OPTIONS: Config menu Printer on –On (Printer function turned on.) or –Off (Printer function turned off.) Press RUN to continue. ® Alere Cholestech LDX System User Manual...
  • Page 17 When “English” is the selected language, AM or PM is displayed. When any other language setting is selected, the hours are shown in 24-hour format from 00:00 to 24:00 hours. NOTE: Press STOP at any time to exit the Configuration Menu. ® Alere Cholestech LDX System User Manual...

  • Page 18: Alere Cholestech Ldx Optics Check

    Optics Check Cassette at room temperature in the case provided. Do not touch the reaction bar or allow it to become wet, dirty or scratched. Do not ® use a damaged or expired Alere Cholestech LDX Optics Check Cassette. ®...

  • Page 19: Optics Check Cassette Test Procedure

    Optics Check Cassette Test Procedure ® Do not use an Alere Cholestech LDX Optics Check Cassette that has become damaged or altered in any way. NOTE: Do not place any blood sample on the cassette. 1. Press the RUN button. After verifying the Selftest OK message, the drawer will open.

  • Page 20: Testing Procedure

    Load cassette and press RUN..(X) X = W or S X indicates current sample setting. W= Whole Blood, S= Serum 6. Place the sample into the cassette well. Use the Alere ® Cholestech LDX Capillary Tube for fingerstick samples. ®...
  • Page 21 During the test, the screen will display: [Test Name(s)] Running**** 9. Put everything that came into contact with the blood samples or control, calibration verification or proficiency testing material into a biohazardous waste container. ® Alere Cholestech LDX System User Manual...
  • Page 22 15. Record the results on the appropriate form. 16. To run another test cassette, press RUN once. Load cassette and press RUN..(X) 17. Repeat step 3, and steps 6 through 15. ® Alere Cholestech LDX System User Manual...
  • Page 23 19. If necessary, press the DATA button to view the results from the last cassette tested. NOTE: Pressing the RUN button will erase the previous result. ® Alere Cholestech LDX System User Manual...

  • Page 24: Performing A Fingerstick

    1. The patient should sit quietly for five minutes before the blood sample is collected. 2. Put a capillary plunger into the end of an Alere™ capillary tube with the colored mark. Set it aside. 3. Choose a spot on the side of one of the center fingers of either hand.
  • Page 25 9. Fill the capillary tube within 10 seconds. 10. Wipe off any excess blood from the finger and have the patient apply pressure to the puncture until the bleeding stops. ® Alere Cholestech LDX System User Manual...
  • Page 26 If blood stops flowing, wipe You can improve blood flow by finger firmly with gauze. reopening the puncture. WARNING: Squeezing the finger excessively may cause inaccurate test results. ® Alere Cholestech LDX System User Manual...

  • Page 27: Using Your Minipet Pipettes

    NOTE: Keep the cassette level at all times after applying the sample. For additional information about proper handling of blood specimens, see the package insert for the test cassette you are using. ® Alere Cholestech LDX System User Manual...

  • Page 28: Quality Control

    Alere Cholestech ® System. Choosing Quality Control Materials Liquid Level 1 and Level 2 controls that work well with the Alere ® Cholestech LDX System are available. If you use other controls, you will need to establish ranges for the Alere ®...
  • Page 29 The quality control results should be in range before testing patient samples. See “Results Outside the Control Range” on page 28 if they are not. Please call Alere to report any problems or if you have any questions about quality control. Control Range Results for Alere™...

  • Page 30: Results Outside The Control Range

    • If results are in range, continue testing patient samples. • If the control is still outside the acceptable limits, contact Alere. Do not use the analyzer for testing patient samples until the problem is resolved. ® Alere Cholestech LDX...
  • Page 31 Cassette RETEST with sample from same control vial using NEW cassette. CONTINUE TESTING Within patient samples Limits? RETEST with sample from a NEW control vial using a NEW cassette Within Limits? Call Alere ® Alere Cholestech LDX System User Manual...

  • Page 32: Risk Assessment

    Risk Assessment Coronary Heart Disease (CHD) Risk Assessment Program ® The Alere Cholestech LDX CHD Risk Assessment Program is based on data from the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults.* The relationship between these risk factors and CHD is derived from the Framingham Study.

  • Page 33: Performing A Chd Risk Assessment

    4. After all patient risk factor data needed for the CHD Risk Assessment Program has been entered, the result will be displayed like this: 10-Year CHD Risk=13% ® Alere Cholestech LDX System User Manual...
  • Page 34 If the answer to “Print?” is “no,” only regular test results will be printed. 8. You may exit the CHD Risk Assessment Program by pressing STOP at any time during the program. The result will be N/A. ® Alere Cholestech LDX System User Manual...

  • Page 35: Risk Assessment Flowchart

    Risk Assessment Flowchart ® The Alere Cholestech LDX Analyzer allows you to access a CHD Risk Assessment Program based on the Framingham Study. To access this program, you must first run a patient sample on a test cassette that includes both total cholesterol (TC) and HDL cholesterol.

  • Page 36: Risk Assessment Modeling

    CHD Risk Assessment Modeling After running a test and performing an initial risk assessment, ® the Alere Cholestech LDX CHD Risk Assessment Program allows you to change the information in the file to see how these changes will impact the patient’s risk of CHD. This helps to illustrate the effect that lifestyle changes can have.

  • Page 37: Troubleshooting & Maintenance

    • Routine cleaning: ® • Clean the outside of the Alere Cholestech LDX Analyzer case with a clean, damp cloth. If necessary, a mild detergent or disinfectant (such as a 5% bleach solution) may be used. Do not immerse the analyzer in water or other cleaning fluid.

  • Page 38: Precautions And Warnings

    Do not allow any liquid, except the sample in a cassette, inside the analyzer case. If a liquid is spilled on the analyzer, unplug the power supply and call Alere at once. • The analyzer drawer must be left empty when not in use.

  • Page 39: Corrective Action

    Call Alere. An electrical Disconnect/Reconnect Calibration problem occurred, analyzer from power Fail or the analyzer supply. If message Call Tech lost its optical reappears, call Alere. Service calibration information. ® Alere Cholestech LDX System User Manual...
  • Page 40 Check reached. expiration date on cassette pouch or box. Internal battery Call Alere. Internal battery Low Battery voltage is too low. is not user serviceable. Unable to read 1. Wipe magnetic stripe Mag Read...
  • Page 41 The cassette is Repeat test with a new malfunctioning. cassette. The humidity Call Alere. RH Sensor sensor has Fail become disconnected or has failed. ® Alere Cholestech LDX System User Manual...
  • Page 42 Dispose of used cassette (nnnn) analyzer. appropriately. The cassette was Repeat test with a new placed in the cassette. Call Alere if drawer incorrectly. message reappears. The cassette is Repeat test with a new malfunctioning. cassette. ®...

  • Page 43: Limited Warranty

    Analyzer. Return the malfunctioning analyzer to Alere. Note the return authorization number on both the shipping box and the airbill and send the analyzer back to Alere as soon as possible following receipt of the replacement analyzer. Disposal Procedure The product may come into contact with blood during testing.

  • Page 44: General Specifications

    • Relative humidity from 20% to 80% • Pollution degree: Class 2 ® If the equipment (Alere Cholestech LDX Analyzer) is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. ®...

  • Page 45: Glossary Of Terms

    In Vitro Diagnostic: A diagnostic test done outside the body ROM: Read-only memory Return Policy Please contact Alere™ Product Support prior to returning any defective components. Refer to the Contact Alere section for additional information. ® Alere Cholestech LDX System User Manual...

  • Page 46: Contact Alere

    Alere™ Product Support Contact one of the following Alere™ Product Support Care Centers or your local distributor if you have any questions regarding the use of your Alere™ product. You may also contact us at www.alere.com. Europe & Middle East + (44) 161 483 9032 EMEproductsupport@alere.com...

  • Page 47: Symbols

    Use By Manufacturer Biological Risks Caution, Consult Direct Current Waste Electrical accompanying & Electronic Documents Equipment This Direction Up Fragile Keep Dry Temperature Sufficient for <n> Do Not Reuse Limitation Biohazard Telephone CRMLN Certified ® Alere Cholestech LDX System User Manual...
  • Page 48 For Professional Use Only TÜV Rheinland Product Safety TÜV Rheinland Product Safety Certificate demonstrating full compliance with the GPSG (German equipment safety law) for Germany, but it also demonstrates compliance to the LVD (minimum EU requirement) ® Alere Cholestech LDX System User Manual...
  • Page 50 San Diego, CA 92121 USA 30175 Hannover www.alere.com Germany The Alere Logo, Alere and Cholestech LDX are trademarks of the Alere group of companies. MiniPet is a trademark of TriContinent Scientific, Inc. © 2013 Alere. All rights reserved. PN: 26189en Rev. D...

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