CholestechLDXTraining 2

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					 Cholestech LDX…Procedures
           1. Gently squeeze up a small drop of blood and wipe away

           2. With your thumb laying along the top of the patient’s
              finger and your fingers curled up under it, gently
              squeeze with the whole length of your thumb to begin
              getting the blood sample up.

           3. Keeping the capillary tube horizontal, fill it
              up to the black line on the tube with the
              blood sample (within 10 seconds). It will
              take a few gentle squeezes of the finger to
              fill the tube

         4.   Check that there are no air bubbles
              contained in the capillary tube as this will make it
              unsuitable for testing

         5.   Holding the capillary tube vertically over the sample well
              of the cassette, dispense all of the sample into the well

         6.   Press Run on the LDX analyser to
              open the cassette drawer. Picking up
              the cassette by the sides (as before)
              load it into the cassette drawer taking
              note of the picture of the cassette on
              the base of the drawer indicating

         7.   Press Run to close the drawer and
              start the test

         8.   Within 5 minutes the cassette drawer will open and the
              results will be displayed on the screen

Prepared by: Peter Merrilees                                   March, 2006
Medical Device Manager POCD                                     Page 1 of 7
Performing a CHD Risk Assessment
        To perform a CHD Risk Assessment on a patient using the
        Risk Assessment program built into the LDX analyser:

            Check that the Configuration Menu on the LDX analyser
             has the menu group Risk set on CHD Risk and test a
             patient using a test cassette that has at least Total
             Cholesterol and HDL Cholesterol

            When the test is complete use the Data button to scroll
             through the results until the screen displays:
                  RUN = yes,        STOP = no

            Press the Run button to enter the Risk Assessment
             program, then use the Run and Data buttons to enter
             answers to the patient questionnaire in the same way
             that they were used to set the Configuration Menu. The
             menu will progress as shown below:

                  CHD risk data
                  Age = 20-34

                  CHD risk data
                  Sex = M

                  CHD risk data
                  Smoke = No

                  CHD risk data
                  SBP = <120

                  CHD risk data
                  BP Treated = No

                   10 Year CHD
                   Risk = 1%

Prepared by: Peter Merrilees                               March, 2006
Medical Device Manager POCD                                 Page 2 of 7
            Please note that the data shown in bold and italics is to
             be altered to match your patient
Running an Optics Check on the LDX
        An LDX Optics Check cassette will be included with your LDX
        system on purchase. The Optics Check cassette is a
        reusable cassette used to confirm the optical measuring
        system in your LDX analyser is in correct alignment. It should
        be stored at room temperature in the plastic case provided
        and used regularly until its expiry. As with all other test
        cassettes for the LDX, the Optics Check cassette should only
        be touched at each side. It is recommended that the Optics
        Check cassette is used each day prior to performing patient
        testing, and after the LDX system has been moved.

        To run an Optics Check cassette:

            Press the Run button to open
             the cassette drawer

            Load the Optics Check
             cassette in the drawer

            Press Run again to begin the optics test

            Within a few seconds the results for the Optics Check
             will be displayed on the screen

            Confirm the 4 numbers shown are
             within the desired range as shown on the test cassette,
             and record them in your Optics Check log

            Should the numbers fall outside the desired range the
             message “Optics Test Fail” will appear above the 4 sets
             of numbers. This will disable the analyser until an optics
             test is run successfully

Prepared by: Peter Merrilees                                 March, 2006
Medical Device Manager POCD                                   Page 3 of 7
Performing Quality Control on the LDX
        Quality Control refers to testing done to ensure your system is
        performing to expectations and giving dependable results. It
        is recommended that you perform Quality Control using the
        Quality Control material manufactured by Cholestech and
        supplied through Point of Care Diagnostics. Quality Control is
        recommended to be run with each new delivery and/or lot
        number of test cassettes you receive.

        The Cholestech Quality Control material
        comes in a box containing 3 bottles of Level 1
        QC (red cap), 3 bottles of Level 2 QC (black
        cap) and a package insert (don’t throw out the package insert
        until the Quality Controls from that box are finished). The
        Quality Control is in liquid form and is ready to use. The
        package insert has the:

            Storage instructions (refrigerate at 2o – 8oC)

            Expiration date (never use expired material)

            Instructions

            Sample type to set the LDX to

            Control Range that results must fall within

        To run a Quality Control on the LDX system you should
        ensure you have all the materials ready:

            LDX analyser turned on and warmed up

            Quality Control material at room temperature
             (out of the fridge for 15 minutes)

            Mini-Pet Pipette and pipette tips

Prepared by: Peter Merrilees                                  March, 2006
Medical Device Manager POCD                                    Page 4 of 7
           Test cassette at room temperature (out of the fridge for
            at least 10 minutes)
        When running the Quality Control test you should:

            Firmly attach the pipette tip to the pipette (use a new
             pipette tip for each new sample)

            Check the Quality Control package insert to confirm the
             lot number on the package insert is the same as that on
             the Quality Control bottle. Check sample type to set the
             LDX analyser to for testing the Quality Control material.
             Change the sample type setting if necessary

            Open the test cassette sachet and place test cassette
             flat on the bench (touching only the sides of the

            Mix the contents of the Quality Control
             bottle thoroughly before use by grasping
             the top of the bottle and inverting gently 7-
             8 times

            After removing the lid on the Quality Control bottle,
             depress the plunger on the pipette and dip the pipette tip
             into the sample, releasing the plunger gently before
             withdrawing from the bottle. Confirm there are no air
             bubbles in the pipette tip

            Place the pipette tip into the sample
             well of the test cassette and dispense
             the sample by pressing down on the
             plunger. Move the pipette tip our of
             the sample well before releasing the
             plunger to avoid drawing any of the
             sample back into the pipette tip

               Press Run on the analyser and place the test cassette
               in the cassette drawer before pressing Run again to
               start the test

Prepared by: Peter Merrilees                                  March, 2006
Medical Device Manager POCD                                    Page 5 of 7
            Once the test is complete (5 minutes) compare the
             results to the Control Range on the package insert
Care for your LDX system
        There is minimal amount of care required for the LDX analyser
        system. It is recommended you clean the
        outside of the analyser with a clean cloth
        lightly dampened with water or a 1:20 bleach
        solution (in the case of a blood spillage).
        Don’t allow the analyser to get wet and don’t
        use abrasive cleaners. The inside of the
        cassette drawer may be cleaned of dried
        blood with a cotton bud dampened with a 1:20
        bleach solution and then dried with an unused
        cotton bud. Do not insert the cotton bud deep into
        the analyser. This cleaning should be performed
        on a weekly-fortnightly basis.

        LDX test cassettes should be kept away from all
        magnetic fields to avoid damage to the magnetic
        strip on the cassette, and the test cassette sachet
        should not be opened until ready to perform a test.

        All disposable materials used in performing tests on the LDX
        system such as:

            Lancets

            Reagent cassettes

            Quality Control material

            Capillary tubes and plungers

            Pipette tips

            Swabs/tissues

Prepared by: Peter Merrilees                                  March, 2006
Medical Device Manager POCD                                    Page 6 of 7
        should be regarded as bio-hazardous waste and disposed of
        into approved ‘Hazardous Waste’ and ‘Sharps’ containers, or
        as recommended in your accreditation procedure.

Prepared by: Peter Merrilees                               March, 2006
Medical Device Manager POCD                                 Page 7 of 7

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