Alere™ Product Support - hmscweb.com

1 Introduction Our distributors will provide every customer with Product Support and training needed to properly use the Alere Cholestech LDX System. We maintain a staff of qualified Product Support Specialists who are available 24 hours a day, 7 days a week. The Alere Cholestech LDX System consists of a small, portable analyzer and test cassette system. It 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 The Alere Cholestech LDX System is for in vitro diagnostic use only.

2 This guide contains information . questions regarding the use of your Alere Product . You may also contact us at intended to familiarize and instruct the user in the proper use and care of the Alere Cholestech LDX . System. Europe & Middle East + (44) 161 483 9032 System Components Asia Pacific + (61) 7 3363 7711 Africa, Russia, & CIS Analyzer Printer + (972) 8 9429 683 Results from each cassette will print out Latin America on the Alere Thermal + (57) 01800 094 9393 Printer. One, two or three Stop labels may be printed. Canada Button + (1) 613 271 1144 Analyzer Display Screen Data US Button + (1) 877 308 8289 Test Cassette Alere Customer Service Contact the following Alere Service Care Center or your local distributor for order and billing assistance.

3 Cassette You may also contact us at Tray Blood from a fingerstick Run sample is placed into a Button single-use, disposable Phone E Mail Address cassette. + (1) 877 441 7440 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 sample for testing on the heparin anticoagulant. Alere Cholestech LDX . The black plunger System. dispenses the sample 14-913. into the sample well in Alere San Diego, Inc. the cassette. San Diego, CA 92121 USA. The Alere Logo, Alere and Cholestech LDX are trademarks of the Alere group of companies. 2011 Alere. All rights reserved. PLEASE NOTE: Even though the Alere Cholestech LDX System is a CLIA-waived.

4 PN: 26203 Rev. A 2011/04. Cholestech LDX . test system, each laboratory or testing site using the Alere Cholestech LDX System 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 LDX System in accordance with the manufacturer's instructions will void the waived Quick Reference Guide status. The tests will then be considered high complexity. 403 14913. Setup Test Procedure Take the time to examine and familiarize yourself with the contents of the Alere Cholestech LDX System. Open the Drawer Perform a Fingerstick Collect the Sample Dispense the Sample Connecting the Alere Configuration Menu Cholestech LDX Analyzer to the Printer C D.

5 B A Before starting to test, press and hold Press the RUN button on the analyzer. The After cleaning the selected site with alcohol Squeeze the finger gently again until a large Place the end of the capillary tube into the STOP to enter the Configuration Menu and drying it thoroughly, firmly prick the site drop of blood forms. Hold the capillary tube sample well and dispense the sample by pushing cassette drawer will open, and the screen and select options for language, units, with a lancet. Gently squeeze the finger to horizontally by the end with the plunger. Touch down on the plunger. Keep the cassette level will display: sample type, printer, risk assessment, it to the drop of blood without touching the skin. after the sample has been applied.

6 Obtain a large drop of blood. Wipe off the date and time. Load cassette first large drop of blood. Fill the capillary tube within 10 seconds. Plug the printer power Plug the power supply C and press RUN Do not allow any bubbles to enter the supply A into the printer into the Alere Cholestech The DATA button allows you to capillary tube. and the wall or power LDX Analyzer and the wall select choices for each of the menu strip. Connect the end or power strip. Insert the items in the Configuration Menu. The of the printer cable B, end of the white printer RUN button enters your choices and labeled To Printer' to the cable D, labeled To advances you to the next menu item. Insert the Cassette Begin the Test View the Results Print the Results printer.

7 Cholestech LDX , into the analyzer. Loop through the cable Support . Optics Check Running Controls Run the Optics Check Cassette Alere Level 1 and 2 Controls Press the RUN button. Controls must be run Immediately place the cassette into the Press RUN. The drawer will close. When the test Press the DATA button on the analyzer once or The results will print when the test is finished. The drawer will open. following manufacturer's analyzer drawer with the black reaction is finished, the analyzer will beep and the drawer twice (depending on the test cassette) to view Place the Optics Check recommendations. Controls bar toward the analyzer and the brown will open. Put everything that touched the remaining results. Cassette into the cassette must be at room temperature magnetic stripe on the right.

8 Blood sample into a biohazardous waste drawer. Press the RUN before testing. Verify that the container. This reference guide provides a brief summary of the testing procedure. For more information, see the button again to close the lot number on the control vial test cassette and control package insert or the Alere Cholestech LDX System User Manual. drawer. and the assay sheet are the same. Mix each vial by gently inverting at least 7 times immediately before Record Results use. Store controls in the refrigerator when Check to see that the not in use. four numbers are within the acceptable range printed on the Optics Check Cassette. Record Testing QC Material Use the MiniPet Pipette and . FAQ How often do I have to run the controls?

9 Controls should be tested: the results on the tips to measure and dispense Frequently asked questions about the use of the Alere Cholestech LDX System. With each new lot of cassettes;. Optics Check Log. If the the control sample into the With every new shipment of cassettes, even if the lot has been received previously;. numbers are outside the cassette. Place the cassette How do I get a CLIA Certificate of Waiver? When reagents may have been stored or handled in a way that can degrade their performance;. range, the analyzer will in the drawer immediately As otherwise required by your laboratory's standard quality control procedures;. Even though the Alere Cholestech LDX System is a CLIA-waived test system, each laboratory or testing As otherwise required by federal, state and local guidelines.

10 Be temporarily disabled until another optics and press RUN. Record site using the Alere Cholestech LDX System must have a CLIA Certificate of Waiver before starting testing. check is run that falls within range. results on a Quality Control To obtain a Certificate of Waiver, call your state department of health or Alere ( ) for an The Optics Check Cassette is used to check Log. Results must be within application (form CMS-116). Alere can give you the phone number of your state department of health and How should I store my cassettes? the optical system of the analyzer. Run the established ranges before patient samples assist you in filling out the application. When stored refrigerated at 36 46 F (2 8 C), the cassettes are stable until the expiration date printed Optics Check Casette: once each day before can be tested.