Tips for Training New Customers Good Habits: Test Strips Recap vial immediately and tightly after removing a single test strip. Never remove the desiccant from the vial. Do not lay test strips out ahead of time. Don t allow test strip to be out more than 5-8 minutes. Don t store the test strips in your car. This can expose them to extreme hot or cold temperatures and humidity. Good Habits: MEMo Chip Check lot number displayed on screen and on MEMo Chip label against test strip vial. Replace the MEMo Chip each time you open a test strip vial. That way you are sure that you haven t opened a new lot number and kept the old MEMo Chip in the instrument. Don t store MEMo Chip in vial. - Could introduce contaminants into test strip vial. - Could damage test strips. Check Strip for Optics Check Any Check Strip can be used with any instrument. Run when instrument is first opened, if dropped, or after shipment to screening site. Optics Check is not a control, but a verification of the integrity of the instrument. Quality Control At a minimum, run with new lot; new shipment; troubleshooting. There are two sets of QC material: HDL CHOL and Multi-Chem (all other tests). There are separate areas on QC card for single analyte strips and multi analyte strips. If control is not in, clean optics and repeat once. If repeat run is not in, call customer service. Patient Preparation Have the patient sit for the blood collection. Sitting has been shown to result in Cholesterol decreases as much as 10 to 15%. Fasting 8 to 12 hours is recommended for a Lipid Panel. Cleaning Do not use bleach or peroxide. A wrung out alcohol pad followed by gauze is best for either the optics or the exterior. 1
Tips for Training New Customers Fingerstick The middle or ring finger is best. Massage from the base of the hand and work up to the finger. When you re at the top knuckle, give a good squeeze just below it. Don t concentrate on one finger. Massage the whole hand so tissue isn t being pushed into one finger. Use a lancet with 2.8 mm depth. This provides approximately 60 µl of blood flow. Stick with the wide part of the lancet perpendicular to the fingerprint on the side of the finger. With a perpendicular incision, the skin has a tendency to stay open. Wipe away the first drop and massage the finger up to the top knuckle and give another good squeeze. DO NOT squeeze at the finger tip itself. This will result in hemolysis and tissue fluid in the sample. Capillary Collection 15 µl for single test; 30 µl for two tests; and 40 µl for three tests. Hold the capillary pipette at an angle 30 to 45 up from the blood drop. If you angle the capillary tube down, gravity will allow air bubbles into the sample. If blood doesn t immediately flow into the pipette, tap the end on a dry portion of the finger. This will break the surface tension and allow free flow of the blood into the capillary. If during collection, the blood is not flowing freely, try wiping the blood in one direction, then massaging the finger and squeezing at the knuckle again. If blood still isn t flowing freely, wipe the finger in opposite direction in order to break up any platelet aggregates that may be forming. Running a test When inserting the test strip, insert straight in, parallel to the instrument. Do not touch the reaction area of the test strip with your fingers. Do not touch the tip of the capillary to the test strip. Hold the capillary perpendicular and near the test strip. Dispense the sample onto the middle of the test strip allowing the drop to touch the test strip. When test is completed, look at reaction areas on bottom of test strip to ensure that they are completely colored. If there is a half moon, this usually means insufficient specimen was applied. Troubleshooting No LDL calculation on Lipid Panel: CHOL, HDL, or TRIG result was out of range so LDL calculation is invalid. TEST ABORTED: Test strip was probably not inserted completely. Test again with fresh test strip and sample. 2
Competency Checklist Task Overall understanding of instrument Has read the CardioChek PA User Guide. Is able to locate and describe the function of the following: - Display - Enter button - Next button - Test strip insert opening Procedure to insert the MEMo Chip and the MEMo Chip s significance to instrument operation. Procedure for changing instrument batteries. CardioChek PA maintenance and cleaning procedures. Environmental conditions and storage Storage requirements for test strips. Storage requirements for instrument. Environmental testing conditions. Quality Control testing Runs correct controls on specific individual test strips and test strip panels. Recommended frequency for running controls. Verifies acceptable results and recognizes which values warrant repeat testing. Troubleshoots out of range results. Control expires ten months after opening. Specimen Collection/Fingerstick Massages patient s hand to the tip of the finger before collection. Cleans finger using alcohol prep pad. Uses lancet correctly, perpendicular to the fingerprint on the side of the finger. Collects patient sample using capillary collection device. Knows hints for getting a good drop of blood. Disposes of all sharps and waste appropriately. Correct specimen volume: - 15 µl for single analyte. - 30 µl for two analytes. - 40 µl for 3 analytes. 3 User Guide Page All 6 7-8 8 29-30 29 21-22 Package Insert 24-25 Initials
Competency Checklist Task Run test Ensures MEMo Chip matches lot number of test strips. Inserts test strip correctly and recaps test strip vial immediately. Applies proper volume of blood without touching test strip with capillary tube. After testing, inspects bottom of test strip to ensure that all reaction circles are evenly filled with color. Expected results Results where LDL will not be calculated on the Lipid Panel. Linear testing range for each analyte. Memory Retrieves patient results from memory. Retrieves QC results from memory. Clears results from memory. Utility Checks the optics using the instrument check strip. Uses the utility menu to run Quality Control. User set Sets print options. Sets sound options. Sets date and time. Changes the way units are displayed. User Guide Page 25-26 Package Insert 21-22 19-20 20-22 13-17 Initials Language Resets the language. 13 Troubleshooting Is familiar with the troubleshooting chart in the User Guide. 31-33 4
Cleaning Instructions for Analyzers Introduction For best quality results, it is very important to keep your CardioChek brand analyzer clean. The most important part of the analyzer to keep clean is the optical glass (window glass) over the test strip insert opening. These instructions show the proper way to clean your analyzer. (a) Test strip insert opening (b) Test strip guides (c) Optical glass The test strip insert opening is positioned in the lower front of the analyzer. The test strip is inserted here with the raised lines facing up. The test strip guides are positioned on the outer edge. The optical glass is beneath the test strip guides. Materials Needed: 1. Alchohol wipes/prep pad (70% isopropyl alcohol ). 2. Good quality cotton gauze. Cleaning Steps: 1. Locate the optical glass (c) and the test strip guides (b). 2. Open an alcohol wipe/prep pad. Remove any excess alcohol by blotting onto gauze. 3. Fold the wipe and carefully wipe the optical glass and test strip guides clean. If the area is especially dry, this may require additional wipes. 4. Immediately dry the optical glass completely with gauze. Make sure the glass is clean, dry, and completely free from any fingerprints, dust, or smudges. The glass must look clean when held at different angles. NOTE: If the optical glass appears to be scratched, cracked, or fogged after cleaning, please call PTS, Inc. Customer Service for assistance. If the exterior of the analyzer needs cleaning, wipe with a damp (not wet) alcohol wipe or dampen a cloth with water or medical grade disinfectant (such as Sporicidin ) and wipe the surfaces and the display area carefully. Be careful not to get the test strip insert opening (where the test strip is inserted) wet. A number of disinfectants are available to clean/disinfect your analyzer. Do not use bleach, window cleaner, or hydrogen peroxide. 5
CardioChek PA System Menus 6
CardioChek PA Lipid Panel Testing Guide PREPARING TO TEST Cap Double red bandplunger inserts into this end Black band side to blood drop Lancets Plunger Capillary Tube B C F E A D G Testing Supplies CardioChek P A Analyzer (A) with matching Lipid Panel MEMo Chip (B) (shown inserted) PTS Panels Lipid Panel Test Strips (C) Gloves* Sterile lancets (D) Capillary tubes (E) Plungers (F) Gauze* Alcohol wipes (G) Bandages * Biohazardous waste container* 2-AAA batteries* * Not pictured CARDIOCHEK P A LIPID PANEL TESTING GUIDE 1. Insert MEMo Chip. Insert the MEMo Chip that matches the lot number on the test strip vial. Press either button ( or ) to turn the CardioChek P A ON. 2. Insert test strip. Hold the test strip by the end with the horizontal raised lines. Insert the opposite end of the strip firmly into analyzer. Push the strip in as far as it will go. The analyzer will then display APPLY SAMPLE. Lipid Panel Test Strip- This side up Blood application window 4. Get a blood drop. Massage the hand from the palm to the finger. The blood drop forms on the finger. Wipe away the first drop of blood with gauze. Then collect the blood for testing. 5. Collect blood drop. Hold the double red-banded end of capillary tube and touch the blood drop to the blackbanded end of the capillary tube. The capillary will fill with blood automatically until the blood reaches the black band. Make sure the capillary is filled to the black band and has no bubbles. 6. Insert plunger. Insert black plunger into capillary end with double red band. 8. Wait / Read Results. In about two minutes, the CHOL result will appear on the display. (To display other lipids, press the (NEXT) button to scroll through the test results.) Remove and discard strip. DO NOT add more blood to a test strip that has been used. 9. Prepare for next test. If the CardioChek P A analyzer is ON and the last result is still on the display, or the display says RUN TEST, press the Enter button, (left button with a circle on it). The CardioChek P A will display INSERT STRIP and you are ready to go back to Step 2 to perform another test. 3. Stick finger. Wipe the finger with an alcohol wipe and let finger dry. Remove the cap from a lancet. Press lancet against side of finger until the lancet clicks. Hold strip by this end 7. Dispense blood. With APPLY SAMPLE displayed, hold capillary directly over the test strip white blood application window and push plunger down slowly and smoothly. Dispense all of the blood into the blood application window. (Note: The analyzer shuts down if idle for 3 minutes.) For help, please see other side. Black band Blood application window For help, contact PTS Customer Service +1-877-870-5610 (toll-free in the USA) +1-317-870-5610 (outside the USA) E-mail: inforequest@cardiochek.com 7
CardioChek PA Lipid Panel Testing Guide 8