Thank you for taking the time to learn more about your CardioChek Plus analyzer. You’re one step closer to greater efficiency, more patient engagement, and improved health outcomes through point of care testing. In this video, we’ll go over everything you need to know about setting up the analyzer, checking the system and running controls, running a test, cleaning and disinfecting the analyzer, and sorting and handling the analyzer. Let’s get started.

First, we’ll help you get familiar with the components of your CardioChek Plus analyzer.

The display shows test results, messages, the time, the date, and stored results.

The ENTER button allows you to turn the analyzer on and accept menu choices.

The NEXT button allows you to turn the analyzer on and advance to the NEXT menu option.

The MEMo chip port is where you’ll insert the MEMo chip that comes with your PTS Panels test strips.

 The reflectance test strip slot is where you’ll insert the gray check strip when checking the analyzers electronic and optical systems and your reflectance test strip when it’s time to run a patient test.

The electrochemical test strip port is where you’ll insert the PTS Panels electrochemical test strips. The USB port allows you to connect to a PTS Connect printer or PTS Connect data management product.

First, install the batteries. The CardioChek Plus analyzer uses four AA alkaline batteries. You will find the battery door on the back of the analyzer. Open the battery door on the back of the CardioChek Plus analyzer by releasing the latch and pulling the door away from the back of the analyzer. Install the batteries with the positive and negative terminals facing as indicated in the markings on the inside compartment. Before moving on, please take a moment to make sure you’ve inserted the batteries correctly. Batteries that are not installed properly can cause damage to the analyzer.

Before your first use of the analyzer, you’ll need to set the language, date, and time.

Turn on the analyzer by pressing either the NEXT or ENTER button. The screen will read language.

 

Press ENTER. English will appear. Press ENTER to set the analyzer’s language to English. If you’d like to select a different language, press NEXT until you find the language you want, then press ENTER.

Now, let’s set the date and time. After setting the language, Set Time will be displayed on your screen. Press ENTER. You will see a date and time displayed on your screen.

Press ENTER to accept the default year or press NEXT to advance the year. Press ENTER to select the year. Do the same for the month, day, and time.

Before you run a test on a patient, it’s important to verify that the analyzer is working properly. You can test the analyzer’s electronic and optical systems by using one of the gray check strips included in your carrying case. We recommend that you run a check strip verification each day of testing if the analyzer has been dropped and when a result is not consistent with expected results. To run a check strip verification, first make sure the MEMo chip is not in the analyzer.

Turn on the analyzer by pressing either the NEXT or ENTER button. Place the analyzer on a flat, stable surface.

Press NEXT until utility appears on your screen. Then press ENTER. Check Strip will appear on the screen. Press ENTER. When Insert Strip appears on the screen, insert the gray check strip, ribs side up, into the reflectance test strip slot at the bottom of the analyzer.

Do not move the analyzer during testing. If the analyzer screen says Passed, good news. You’re ready to run controls. If the analyzer says Failed, you’ll want to make a few adjustments and try again.

First, clean the optical glass with an alcohol wipe and dry with gauze. Then, retest. If the test fails again, try changing the batteries, cleaning the check strip with an alcohol wipe, or using the other check strip included in your analyzer case. If your check strip verification still fails after all these measures have been taken, please do not use the analyzer. Call customer service for assistance.

Running quality control helps to ensure the accuracy of your test results. We recommend running controls with each new shipment, with each new PTS Panels test strips lot number, in accordance with state, local and federal regulations and your facility’s requirements.

To run controls, first wash, rinse thoroughly and dry your hands then put on your gloves. Then gather the following materials: the CardioChek Plus analyzer, the liquid controls materials, the quality control instructions which can be found in the box with your control materials, the quality control range card which can be found in the box with control materials or at ptsdiagnostics.com,  The PTS Panels test strips and MEMo chip. Medical quality disposable gloves.

Check the expiration dates on both the PTS Panels test strips and the control materials to make sure they have not expired. Once opened, controls are stable at room temperature for 10 months or until the expiration date on the box, whichever comes first. Make sure that the MEMo chip lot number and the test strip’s lot number match. Before you insert the MEMo chip into the analyzer, press the NEXT button until your analyzer screen says utility.

Press ENTER. Then press NEXT until the screen says Run Control. Insert the MEMo chip that corresponds with your PTS Panels test strips into the MEMo chip port at the top of the analyzer.

Then press ENTER. Make sure that the lot number that appears on your analyzer display and the test strip slot number match. Check to see if the reflectance test strip slot at the bottom of the analyzer is clean. If not, clean with an alcohol wipe and dry with gauze. NEXT, remove one eGLU test strip from the vial and immediately replace the lid. Hold the test strip with the arrow pointing toward the analyzer.

Insert the strip into the electrochemical test strip port. Gently push the test strip into the port as far as it will go. NEXT, remove one lipid panel test strip from the vial and immediately replace the lid. Hold the test strip by the end opposite of the blood application window. Insert the end with the blood application window into the reflectance test strip slot.

Gently push the test strip into the slot as far as it will go. When the test strips are inserted correctly, the screen will say apply sample.

Apply solution to the igloo test strip first. To do this, pick up the vial of level one control solution. Invert to mix.

Remove the cap, turn the vial upside down and hold the tip of the vial directly in front of the tip of the test strip without touching the vial to the strip. Carefully squeeze the vial to deliver one drop of control solution to the tip of the electrochemical test strip.

Next, apply solution to the lipid panel test strip. Again, turn the vial upside down and hold the tip directly above but not touching the test strip blood application window. Carefully squeeze the vial to deliver two drops of control solution to the blood application window. Replace the cap on the vial of control solution.

The analyzer will automatically begin testing and will return results in 1.5 to 2 minutes. Do not move the analyzer while it is testing.

 

Once the results appear, check your range card to see if your results are within the specified range. Make sure you are looking under the header, Single Analyte Test Strips on the card for the Glucose/eGLU result. Make sure you are looking under the header, Multi- Analyte test strips on the card for Cholesterol, HDL Cholesterol and Triglycerides results.

Record your results and remove the test strips. Ensure that all circles on the back of the lipid panel test strip are completely colored. Then, discard the strips used for level one in a biohazard container. Press ENTER to move on to the level two control test.

Using new test strips and the level two vial of control solution, repeat the procedure. If your results are within range, you’re ready to move on to patient testing.

If your results are not within range, first, remove the lipid panel test strip. Look at the circles on the back.

Are the circles uniformly colored? If not, it’s likely that the amount of solution applied to the strip was insufficient. Try running the test again with a new test strip. If the circles are completely colored but your results are still not within range, refer to the test strips package insert and control package insert for troubleshooting tips.

Test one more time. If the second control test fails, please do not continue to use the analyzer. Call customer service for help.

Once you’ve verified that your analyzer is working properly by running a check strip and controls, you’re ready to run a patient test.

First, gather all of the items you’ll need. Analyzer, PTS Panels lipid panel test strips, PTS Panels eGLU test strips, MEMo chip, lancet, PTS collect capillary tubes (40 µL), gauze, alcohol wipes, medical quality disposable gloves, biohazard container.

Before handling the analyzer and test strips, wash, thoroughly rinse, and dry your hands. Then put on gloves.

Begin by performing a 3-point check. Insert the MEMo chip into the MEMo chip port at the top of the analyzer, then turn the analyzer on by pressing either button. Make sure that the lot numbers on the display, on the MEMo chip, and on the test strip files match.

Set the analyzer on a flat stable surface.

NEXT, remove one eGLU test strip from the vial and immediately replace the lid. Hold the test strip with the arrow pointing toward the analyzer. Insert the strip into the electrochemical test strip port. Gently push the test strip into the port as far as it will go. NEXT, remove one lipid panel test strip from the vial and immediately replace the lid. Hold the test strip by the end opposite of the blood application window. Insert the end with the blood application window into the reflectance test strip slot.

Gently push the test strip into the slot as far as it will go.

When the test strips are inserted correctly, the screen will display Apply Sample.

Now it’s time to collect a sample by doing a fingerstick on the patient. Decide whether you will collect the sample from the middle finger or ring finger. You can ask the patient which they’d prefer. Clean the finger with an alcohol wipe, then make sure the finger is completely dry before proceeding.

With a new sterile disposable lancet, puncture the skin. Stick the finger on the side of the fingertip instead of the center. To get a drop of blood, gently apply pressure to the finger starting at the end of the finger closest to the hand and moving towards the tip. Pressure should be intermittent and it is important not to milk the finger.

The blood drop should be hanging down from the finger to make it easier to collect the sample with a pipette or capillary tube. When running an electrochemical test with a reflectance test, apply the blood sample to the tip of the electrochemical glucose strip and wipe away any remaining blood with gauze from the fingertip. Then, collect a second blood sample for the reflectance test strip.

To collect the blood sample, hold the capillary tube on the stem underneath the bulb, parallel to the floor.

Be careful not to cover the fill lines. Touch the tip of the tube gently to the drop of blood. Let the tube’s capillary action draw the blood into the tube until it reaches the fill line. You may need to squeeze the finger again while collecting in order to collect the appropriate volume of blood.

To dispense the blood sample onto the reflectance strip, hold the bulb of the capillary tube placing your fingers over the two small holes.

In one gentle steady squeeze of the bulb dispense the entire sample onto the strip. Be careful not to touch the tip of the capillary tube to the strip.

Once you’ve applied the sample, do not move the analyzer until the test is complete. Results will appear on your screen in as little as ninety seconds.

Once the results are displayed, remove the test strip. This will help to extend the analyzer’s battery life. It will also allow you to easily check the back of the strip to make sure that the three circles are completely colored. This indicates that you applied enough blood sample to obtain accurate results. If the circles are not completely colored, you may need to try collecting another sample and running the test again with new test strips.

Once the test is complete, record the results and dispose of the test strips in a biohazard container. The average of all CardioChek Plus lipid value results compared to laboratory results on a sample collected at the same time may vary by plus or minus ten percent for total cholesterol, plus or minus twelve percent for HDL cholesterol, plus or minus fifteen percent for triglycerides.

The average of all CardioChek Plus glucose results as compared to laboratory results for a plasma sample collected at the same time are generally within plus or minus fifteen milligrams per deciliter for values less than one hundred milligrams per deciliter and for values greater than or equal to one hundred milligrams per deciliter plus or minus fifteen percent.

To help protect your patients and yourself against bloodborne pathogens, you must fully clean and disinfect your CardioChek Plus analyzer between each patient test and before storing. Start by taking two super sandy cloth wipes out of the container. Fold the wipes in half and forcefully twist them at least three times to wring out excess liquid.

Set one wipe aside. With the first wipe, clean all areas of the analyzer thoroughly. This will remove any left behind organic materials or blood products.

Dry the analyzer with a piece of gauze or allow it to air dry. Dispose of the first super sandy cloth wipe in the biohazard container.

Then, disinfect the analyzer by taking the second wipe and thoroughly wiping all parts of the device again. Stop. Watch for all areas that are beginning to dry and wipe those areas again. You’ll want to keep all areas of the analyzer in contact with the disinfectant for a full two minutes. This gives it time to kill all potential bloodborne pathogens.

Allow the device to air dry completely. Clean the optical glass with an alcohol wipe to remove any residue left behind by the disinfectant. Dry with gauze. Inspect the optical glass holding it at different angles to make sure it is clean before running your NEXT test or placing the analyzer in the case. Remove your gloves, thoroughly clean your hands and put on a new pair of gloves before testing the NEXT patient. Store the PTS Panels test strips and CardioChek Plus analyzer at the temperatures indicated in the package inserts.

Store the MEMo chip in the box with its original lot of test strips. Do not store the MEMo chip in the vial with the test strips. Place the black optical screen cover on the analyzer before storing. Store the analyzer in the case provided. If you plan to store the analyzer for an extended period of time, remove the batteries and store them in the analyzer’s case. Improper battery storage can reduce battery life and cause damage to the analyzer.

 

Congratulations.

Now that you’ve learned more about your CardioChek Plus analyzer and PTS Panels test strips, you’re ready to start generating fast, accurate test results that can help people start down the path to better health. To learn more and to take our free training quizzes, ptsdiagnostics.com/cardiochek-plus-analyzer. Always refer to the user guide, test strip, and control package inserts for additional information.

And if you have any questions, don’t hesitate to call us toll free at 1-877-870-5610 or direct at +1-317-870-5610