LDX Quick Reference Guide
Contents
1. Canada g Sse Button 1 613 271 1144 CANproductsupport alere com A Data T Button 1 877 308 8289 USproductsupport alere com Alere Customer Service Contact the following Alere Service Care Center or your local distributor for order and billing assistance Blood from a fingerstick You may also contact us at www alere com se k Ji sample is placed into a _ sad fee single use disposable Phone E Mail Address cassette 1 877 441 7440 clientservices alere com nun Capillary Tubes Plungers Lancets Blood from a A single use lancet is fingerstick sample used to perform a finger is collected into a stick to collect a blood capillary tube with P sample for testing on the heparin anticoagulant 7 Alere Cholestech LDX 7 A s PA 14 913 The Alere Logo Alere and Cholestech LDX are trademarks of the Alere group of companies PLEASE NOTE Even though the Alere Cholestech LDX System is a CLIA waived 2011 Alere All rights reserved test system each laboratory or testing site using the Alere Cholestech LDX System PN 26203 Rev A 2011 04 must have a CLIA Certificate of Waiver To obtain a Certificate of Waiver call your state department of health or Alere for an application Failure to operate the Alere Cholestech HII ii iii N iii HI iii H HI il LDX System in accordance with the manufacturer s instructions will void the waived status The tests will then be considered high complexity 402. 3 14913 The black plunger System dispenses the sample into the sample well in the cassette Alere San Diego Inc San Diego CA 92121 USA www alere com Setup Take the time to examine and familiarize yourself with the contents of the Alere Cholestech LDX System Connecting the Alere Cholestech LDX Analyzer to the Printer Plug the printer power and the wall or power strip Connect the end of the printer cable B 2 Configuration Menu Before starting to test press and hold STOP to enter the Configuration Menu and select options for language units sample type printer risk assessment date and time Plug the power supply C supply A into the printer into the Alere Cholestech LDX Analyzer and the wall or power strip Insert the end of the white printer labeled To Printer to the cable D labeled To printer Cholestech LDX into The DATA button allows you to select choices for each of the menu items in the Configuration Menu The RUN button enters your choices and advances you to the next menu item the analyzer Loop through the cable support Optics Check Run the Optics Check Cassette Press the RUN button The drawer will open Place the Optics Check Cassette into the cassette drawer Press the RUN button again to close the drawer Record Results Check to see that the four numbers are within the acceptable range printed on t
3. Our distributors will provide every customer with product support and training needed to properly use nN t TO d U C Cl O nN the Alere Cholestech LDX System We maintain a staff of qualified Product Support Specialists who are ilable 24 h day 7 d k The Alere Cholestech LDX System consists of a small portable analyzer and test cassette system It eae B ea i a is easy to use and gives fast and reliable results To run a test just add a sample to the cassette and place it in the analyzer In a few minutes the results will appear on the screen Alere Product Support Contact one of the following Alere Product Support Care Centers or your local distributor if you have any s ET ae The Alere Cholestech LDX System is for in vitro diagnostic use only This guide contains information questions regarding the use of your Alere product You may also contact us at www alere com intended to familiarize and instruct the user in the proper use and care of the Alere Cholestech LDX System Europe amp Middle East 44 161 483 9032 EMEproductsupport alere com Asia Pacific Sys te m Co m po nN nN tS 61 7 3363 7711 APproductsupport alere com Africa Russia amp CIS Analyzer Printer 972 8 9429 683 ARCISproductsupport alere com Results from each cassette will print out Latin America on the Alere Thermal 57 01800 094 9393 LAproductsupport alere com Printer One two or three EA E Stop labels may be printed
4. bles to enter the capillary tube Go View the Results Press the DATA button on the analyzer once or twice depending on the test cassette to view remaining results 4 Dispense the Sample Place the end of the capillary tube into the sample well and dispense the sample by pushing down on the plunger Keep the cassette level after the sample has been applied Print the Results The results will print when the test is finished This reference guide provides a brief summary of the testing procedure For more information see the test cassette and control package insert or the Alere Cholestech LDX System User Manual How often do I have to run the controls Controls should be tested e With each new lot of cassettes With every new shipment of cassettes even if the lot has been received previously When reagents may have been stored or handled in a way that can degrade their performance As otherwise required by your laboratory s standard quality control procedures As otherwise required by federal state and local guidelines How should I store my cassettes When stored refrigerated at 36 46 F 2 8 C the cassettes are stable until the expiration date printed on the cassette pouch and box Cassettes can be stored at room temperature for 30 days Do not use a cassette past the expiration date Do not return cassettes to the refrigerator once they have been stored at room temperature
5. he Optics Check Cassette Record the results on the Optics Check Log If the numbers are outside the range the analyzer will be temporarily disabled until another optics check is run that falls within range The Optics Check Cassette is used to check the optical system of the analyzer Run the Optics Check Casette once each day before patient samples are tested and after the Alere Cholestech LDX Analyzer has been moved or serviced 4 Running Controls Alere Level 1 and 2 Controls Controls must be run following manufacturer s recommendations Controls must be at room temperature before testing Verify that the lot number on the control vial and the assay sheet are the same Mix each vial by gently inverting at least 7 times immediately before use Store controls in the refrigerator when not in use Testing QC Material Use the MiniPet Pipette and a tips to measure and dispense the control sample into the N cassette Place the cassette _ l OS y in the drawer immediately and press RUN Record results on a Quality Control Log Results must be within established ranges before patient samples can be tested S Test Procedure ED Open the Drawer Press the RUN button on the analyzer The cassette drawer will open and the screen will display Immediately place the cassette into the analyzer drawer with the black reaction bar toward the analyzer and the brown magnetic
6. stripe on the right FAQ 2 Perform a Fingerstick After cleaning the selected site with alcohol and drying it thoroughly firmly prick the site with a lancet Gently squeeze the finger to obtain a large drop of blood Wipe off the first large drop of blood O Begin the Test Press RUN The drawer will close When the test is finished the analyzer will beep and the drawer will open Put everything that touched the blood sample into a biohazardous waste container Frequently asked questions about the use of the Alere Cholestech LDX System How do I get a CLIA Certificate of Waiver Even though the Alere Cholestech LDX System is a CLIA waived test system each laboratory or testing site using the Alere Cholestech LDX System must have a CLIA Certificate of Waiver before starting testing To obtain a Certificate of Waiver call your state department of health or Alere 1 877 441 7440 for an application form CMS 116 Alere can give you the phone number of your state department of health and assist you in filling out the application Remember The Alere Cholestech LDX System is only waived for fingerstick or venous whole blood Collect the Sample Squeeze the finger gently again until a large drop of blood forms Hold the capillary tube horizontally by the end with the plunger Touch it to the drop of blood without touching the skin Fill the capillary tube within 10 seconds Do not allow any bub
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