CardioChek® Plus Training Patient Focus Africa Recognizing the linkage between heart attack, stroke and diabetes, the CardioChek® Plus analyzer provides rapid on-site lipid panel plus glucose screening to help identify at-risk individuals. The capability to deliver both results in as little as 90 seconds enables healthcare professionals to improve their throughput, which is particularly important in today’s health promotion and screening environment. Today, this short training will walk us through the steps to run the CardioChek® Plus analyzer properly.

Components www.patientfocus.co.za The components of the CardioChek® Plus include the analyzer, two check strips, four AA (double A) batteries, a carrying case and user guide. PTS Panels® test strips, which include a MEMo Chip® and test strips, are purchased and packaged separately for use with the analyzer. PTS Collect™ capillary tubes are also purchased and packaged separately for use with the analyzer. Other capillary tubes are available for use with the CardioChek Plus analyzer.

Storage and Handling www.patientfocus.co.za Storage Handling Store the analyzer at a temperature between 50-104°F (10-40°C) with a relative humidity between 20-80% Store the PTS Panels® test strips at room temperature (68-86°F / 20-30°C) Handling Handle the analyzer with care Do not operate the analyzer in direct light or by a window Do not scratch or damage the surface of the analyzer or the check strip Use the test strip immediately after removing it from the vial Always replace the PTS Panels vial lid after removing a test strip Keep the MEMo Chip® with the original lot of test strips The CardioChek® Plus analyzer must be stored at a temperature between 50 to 104 degrees Fahrenheit and a relative humidity of 20 to 80 percent. The PTS Panels test strips can be stored at room temperature between 68 to 86 degrees Fahrenheit or refrigerated. Test strips must be brought to room temperature before using. Avoid exposing the analyzer, test strips or any of the supplies to high humidity, extreme heat, cold, dust or dirt. Handle the CardioChek Plus analyzer with care. Do not operate or store the analyzer in direct light or by a window. Do not scratch or damage the surface of the analyzer or of the check strip. The test strip must be used as soon as you have removed it from the PTS Panels vial. Remember to close the vial lid after removing a test strip to protect the test strips from environmental conditions. Keep the MEMo Chip® with the original lot of test strips.

Using the Analyzer www.patientfocus.co.za Enter Next Pressing either ENTER or NEXT turns on the analyzer Pressing ENTER accepts the current menu choice Pressing NEXT advances to the next menu option Pressing and holding both buttons for 3 seconds will turn off the analyzer The analyzer has two buttons: an ENTER button and a NEXT button. The ENTER button is on the left and the NEXT button is on the right. Either button will turn on the analyzer. These two buttons make navigating to a specific screen on the analyzer simple. The ENTER button accepts the current menu choice displayed on the analyzer screen. The NEXT button advances the analyzer to the next menu option. Pressing both buttons simultaneously for 3 seconds will turn off the analyzer. Enter Next

Changing Settings on the Analyzer www.patientfocus.co.za Changing Settings on the Analyzer Navigate to the SETTINGS screen by pressing NEXT and then pressing ENTER Modify wireless, printer setup, sound, units, time and date preferences To change the language: Turn off the analyzer Press and hold ENTER until LANGUAGE is displayed Press ENTER Press NEXT to scroll through the language choices Press ENTER when desired language is displayed You can customize many options on the CardioChek Plus analyzer by navigating to the SETTINGS screen with the use of the NEXT and ENTER buttons. Within the SETTINGS screen, wireless, printer setup, sound, units displayed, and time and date preferences can be updated to meet your needs. The language of the analyzer can be changed as well. Starting with the analyzer off, press and hold ENTER until LANGUAGE is displayed on the analyzer. Press ENTER and press NEXT to scroll through the language options. Press ENTER when the desired language is displayed on the analyzer screen.

Checking the System www.patientfocus.co.za Check Strip Base Navigate to the UTILITY screen by pressing NEXT and then press ENTER Available options CHECK STRIP (Optics test) Use the gray check strip to verify that the CardioChek Plus analyzer’s electronic and optical systems are functioning properly Note: Not a substitute for liquid controls RUN CONTROL (Control test) For technical use only (Patient Focus Africa) An optics test can be run by selecting the CHECK STRIP option in the UTILITY menu. It is recommended that the check strip verification be performed daily, if the analyzer has been dropped, or when a result is not consistent with expected results. Two gray check strips are provided with the CardioChek® Plus, which are used to verify that the analyzer’s electronic and optical systems are functioning properly. Once you have navigated to and selected CHECK STRIP in the analyzer menu, hold a check strip at the base and insert the check strip, ribbed side up, into the reflectance test strip slot when the analyzer displays INSERT STRIP. A result of PASSED or FAILED will be displayed when the optics test is complete. If PASSED is displayed on the screen, the analyzer is ready to run tests upon navigation to the RUN TEST screen. If FAILED is displayed on the analyzer screen, clean the optical block of the CardioChek Plus analyzer with an alcohol wipe and dry with gauze. Inspect the check strip to make sure it is not dirty or damaged. If necessary, clean the check strip with an alcohol wipe. Repeat the optics test once the optical block and check strip have been cleaned and dried and the check strip has been determined to be in good condition. If the check strip is not in good condition, use the additional check strip. As a reminder, the check strip is not a substitute for liquid controls. Please refer to the Quality Controls Testing Training for the CardioChek Plus analyzer, which is available at www.ptsdiagnostics.com/training. This separate training walks through quality control testing. Base

Test Preparation www.patientfocus.co.za Ancillary components Alcohol wipe, gauze, gloves, lancet, capillary tube, bandage Install the MEMo Chip® into the CardioChek® Plus analyzer Conduct a 3-point check Lot numbers must match on the MEMo Chip, test strip vials and analyzer screen Prior to testing, you may need the following ancillary supplies: alcohol wipes, gauze, gloves, lancet, blood collector, such as the PTS Collect™ capillary tube, and bandages. With the recommended supplies now collected, locate the MEMo Chip® in the PTS Panels® test strip box with the test strip vial. Power the analyzer on and install the MEMo Chip into the CardioChek® Plus analyzer. Each vial of test strips comes with a lot-specific MEMo Chip. Navigate to and select RUN TEST to conduct a 3-point check, which is used for confirming the lot number. Check that the lot number matches on the MEMo Chip, test strip vial and analyzer screen.

Test Preparation www.patientfocus.co.za Dosing Requirements Use the PTS Collect™ capillary tubes or similar blood collector to collect the required amount of blood for the PTS Panels® reflectance test strips Sample Volume PTS Panels Test Strips 15 µL 30 µL 40 µL CHOL HDL TRIG GLU CHOL+GLU CHOL+HDL LIPID PANEL CHOL+HDL+GLU METABOLIC With the MEMo Chip® already inserted and the 3-point check complete, follow the displayed on-screen directions to INSERT STRIP and insert the test strip. Determine the amount of blood needed to run the PTS Panels® test by referencing the test strip package insert. Select the appropriately sized PTS Collect™ capillary tube or similar blood collector and collect the blood. Please refer to the Fingerstick Technique Training and the PTS Collect Capillary Tube Training, which are available at www.ptsdiagnostics.com/training. These separate trainings walk through how to conduct a good fingerstick and how to collect the blood sample.

Fingerstick Technique www.patientfocus.co.za Fingerstick Technique Side For testing with the PTS Panels® lipid panel plus eGLU smart bundle, a blood drop icon will direct you to dose the eGLU test strip on the right. Dose the end (not the top) of the eGLU test strip by touching the end of the strip with your finger. Once the sample is applied, a beating heart appears above the eGLU test strip on the screen which indicates the eGLU test is running. Next, a blood drop icon will direct you to dose the lipid panel test strip on the left. Wipe the finger with gauze to remove any residual blood and then collect 40µL of blood with a PTS Collect™ capillary tube or similar blood collector. Apply the blood to the lipid panel test strip. Within one to two minutes, the results will be displayed. Remove both test strips and discard appropriately. If desired, it is possible to skip the eGLU test by holding the NEXT button until the analyzer strikes the eGLU test out. This allows you to go straight to the lipid panel test. Test results are automatically stored in the CardioChek® Plus analyzer’s memory. To view results, turn on the analyzer and navigate to the MEMORY screen. Select either CHEM or CONTROL to view the stored results. For additional details, please refer to your analyzer’s user guide and test strip package insert. the finger.

Capillary Tube Technique www.patientfocus.co.za Capillary Tube Technique Start collection at an upright angle. As the capillary tube fills up with blood, bring it down to 180 degrees to fill up to the thin black line. For testing with the PTS Panels® lipid panel plus eGLU smart bundle, a blood drop icon will direct you to dose the eGLU test strip on the right. Dose the end (not the top) of the eGLU test strip by touching the end of the strip with your finger. Once the sample is applied, a beating heart appears above the eGLU test strip on the screen which indicates the eGLU test is running. Next, a blood drop icon will direct you to dose the lipid panel test strip on the left. Wipe the finger with gauze to remove any residual blood and then collect 40µL of blood with a PTS Collect™ capillary tube or similar blood collector. Apply the blood to the lipid panel test strip. Within one to two minutes, the results will be displayed. Remove both test strips and discard appropriately. If desired, it is possible to skip the eGLU test by holding the NEXT button until the analyzer strikes the eGLU test out. This allows you to go straight to the lipid panel test. Test results are automatically stored in the CardioChek® Plus analyzer’s memory. To view results, turn on the analyzer and navigate to the MEMORY screen. Select either CHEM or CONTROL to view the stored results. For additional details, please refer to your analyzer’s user guide and test strip package insert.

Conducting a Test www.patientfocus.co.za PTS Panels® Lipid Panel+eGLU Smart Bundle™ Pack test strips Wipe the finger with gauze to remove 1st drop of blood Dose the eGLU test strip by gently touching the finger to the strip until the monitor beeps (take the finder to the monitor) Collect 40µL of blood in capillary tube Dose the lipid panel test strip – Squeeze all the blood out of the 40ul capillary tube onto the strip, making sure not to touch the strip To Skip LIPID test, only insert the eGLU strip, dose the eGLU strip by taking finger to the strip and gently touching finger to the strip until the monitor beeps, and then hold down the NEXT button until the Glucose results is displayed on the screen. To skip the eGLU test, hold the NEXT button until the analyzer strikes the eGLU test out, and dose the LIPID strip with 40ul blood. For testing with the PTS Panels® lipid panel plus eGLU smart bundle, a blood drop icon will direct you to dose the eGLU test strip on the right. Dose the end (not the top) of the eGLU test strip by touching the end of the strip with your finger. Once the sample is applied, a beating heart appears above the eGLU test strip on the screen which indicates the eGLU test is running. Next, a blood drop icon will direct you to dose the lipid panel test strip on the left. Wipe the finger with gauze to remove any residual blood and then collect 40µL of blood with a PTS Collect™ capillary tube or similar blood collector. Apply the blood to the lipid panel test strip. Within one to two minutes, the results will be displayed. Remove both test strips and discard appropriately. If desired, it is possible to skip the eGLU test by holding the NEXT button until the analyzer strikes the eGLU test out. This allows you to go straight to the lipid panel test. Test results are automatically stored in the CardioChek® Plus analyzer’s memory. To view results, turn on the analyzer and navigate to the MEMORY screen. Select either CHEM or CONTROL to view the stored results. For additional details, please refer to your analyzer’s user guide and test strip package insert.

www.patientfocus.co.za of the Alcohol Swab Cleaning and disinfection of devices or analyzers that come in contact with blood or blood products is critical to avoid transmitting bloodborne pathogens between patients and healthcare professionals. Please refer to the Cleaning and Disinfection Training, which is available at www.ptsdiagnostics.com/training. This separate training walks through how to care for and clean your CardioChek® Plus analyzer. Additionally, the analyzer user guide outlines the cleaning and disinfection instructions. of the Alcohol Swab

Customer Service Thank you! www.patientfocus.co.za Customer Service Thank you! Patient Focus Africa Customer Service Office: 011 021 5760 Hours of Operation: 7:30am-4:30pm Monday through Thursday 7:30am-3:00pm Friday This successfully completes training on the CardioChek® Plus analyzer! If you have any questions in the future, please contact our Customer Service team at the number listed on the screen. If desired, please navigate to the training section of the PTS Diagnostics webpage to access the CardioChek Plus analyzer quiz and earn your Certificate of Participation. Thank you again for your time and attention during this training! CardioChek, MEMo Chip, PTS Collect and PTS Panels are trademarks of Polymer Technology Systems, Inc. © 2016 Polymer Technology System, Inc. All other product names and trademarks are property of their respective owners. LIT001603 Rev.4 8/16