Te st System User Guide For Professional Use Portable Whole Blood Test System
Table of Contents 1 2 Introduction: CardioChek Plus System Intended Use . . . . . . . . . . . . . . . . . . . . 5 Important Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 About the CardioChek Plus Test System. . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 The CardioChek Plus Test System and Operating Principle. . . . . . . . . . . . . . . . . . . . . . . .
6 7 Running a Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Blood Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Testing Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This analyzer is a component of a test system that includes PTS Panels® eGLU test strips, PTS Panels glucose test strips and PTS Panels lipid panel test strips. The PTS Panels test strip box includes a lot-specific MEMo Chip that contains the assay calibration curve and other important information about the assay. PTS Panels test strips are sold separately, and are available as single- and multiple-analyte test strips.
2 About the CardioChek Plus Test System A Display Display shows test results, messages, time, date, and stored results. The CardioChek Plus test system consists of three main parts. These include the CardioChek Plus analyzer, PTS Panels test strips, and a lot-specific MEMo Chip. B Enter Button Press this button to turn on the analyzer or to accept the current menu choice. The analyzer employs both light reflectance and electrochemical biosensor technology to measure an enzymatic chemical reaction.
The MEMo Chip Each package of PTS Panels test strips contains a color-coded lot-specific MEMo Chip. The MEMo Chip contains the settings for each test. The bottom has a label with the test name and lot number. Always insert the MEMo Chip in the port at the top of the analyzer with the lot code number facing down. What does the MEMo Chip do? The MEMo Chip contains proper settings for the test strip lot you are using.
PTS Panels® Test Strips PTS Panels test strips are designed for specific analytes. A test strip is inserted into the analyzer, then blood is applied to the blood application window for reflectance tests or the tip of the test strip for electrochemical tests. As previously described, the ensuing chemical reaction produces a color change or an electrical current, which the analyzer measures and compares to the calibration curve stored in the lot-specific MEMo Chip.
PTS Panels Glucose Test Strips – Limitations of the Procedure 1. The analyzer should not be used to test critically ill patients. 2. Blood samples from patients in shock, patients with severe dehydration, or patients in a hyperosmolar state (with or without ketosis) have not been tested. It is not recommended to test those samples with this system. 3. Not for use on patients who are severely hypotensive. 4.
3 Setup Battery Use and Replacement The CardioChek Plus analyzer requires four (4) AA 1.5 volt high-quality alkaline batteries. When to Replace the Batteries The analyzer will give you an indication on the display that the batteries need to be changed. When the display reads REPLACE BATTERIES, no more tests can be run until the batteries are changed. Always replace the batteries with high-quality alkaline batteries. It is recommended to keep a spare set of batteries on hand.
CardioChek Plus Analyzer Menus INSTALL MEMO CHIP RUN TEST 11:35 11:35 03/05/2013 UTILITY MEMORY 05/30/2013 11:35 03/05/2013 11:35 SETTINGS 05/30/2013 CHECK STRIP CHEM 11:35 11:35 03/05/2013 03/05/2013 CONTROL 11:35 03/05/2013 03/05/2013 11:35 03/05/2013 TECHNICAL SUPPORT WI-FI MEMO CHIP INSTALLED USE CODE 11:35 INFORMATION 11:35 03/05/2013 RUN CONTROL 11:35 03/05/2013 ABOUT CardioChek Plus PRINT 3 SECONDS 11:35 INSERT STRIP 03/05/2013 03/05/2013 11:35 EXIT 11:35 11
How to Turn Off the Analyzer To turn off the analyzer, press both buttons (Enter and Next) at the same time for three seconds. After three minutes of idle time (without a test strip or check strip inserted), the analyzer will perform a 10-second countdown and turn off. To stop shutdown, press either button. You can also remove the batteries to turn off the analyzer. Setting Language The first time the analyzer is turned on, you will be required to set the language, date, and time.
How to Set the Units The CardioChek Plus analyzer may be shipped with preset units. If the SETTINGS menu does not display UNITS, the analyzer is locked in preset units. The units cannot be changed if the system has been locked. If your analyzer’s units have not been preset, follow the steps listed below to change your units to mg/dL, mmol/L, or g/L (e.g., in the US, the correct units for glucose are mg/dL and the units are preset to mg/dL). 1.
How to Set the Wireless Connectivity On or Off The CardioChek Plus analyzer wireless communication has been preset to off. To turn the wireless connectivity to on or off, follow the steps listed below: 1. If the analyzer is off, press either button to turn on the analyzer. Wait for the display to read INSTALL MEMO CHIP or INSERT STRIP. Note: If RUN TEST is displayed, go to Step 3. 2. Press Next. The display will read RUN TEST. 3. Press Next until SETTINGS is displayed. 4. Press Enter.
4 Checking the System How to Get Help and Information Regarding Your CardioChek Plus Analyzer 1. If the analyzer is off, press either button to turn on the analyzer. Wait for the display to read INSTALL MEMO CHIP or INSERT STRIP. Note: If RUN TEST is displayed, go to Step 3. 2. Press Next. The display will read RUN TEST. 3. Press Next until INFORMATION is displayed. 4. Press Enter, then TECHNICAL SUPPORT is displayed. 5. Press Enter to display contact information. 6.
5 Quality Control Testing How to Use the Analyzer Check Strip 1. Turn on the analyzer by pressing either button. 2. When INSTALL MEMO CHIP or RUN TEST is displayed, press Next until UTILITY is displayed. Press Enter. 3. Press Enter when CHECK STRIP is displayed. 4. Hold the check strip at the base and insert the check strip, ribbed side up, into the reflectance test strip slot when INSERT STRIP is displayed. 5. The analyzer should display PASSED, along with a checkmark icon.
6 Running a Test How to Run a Quality Control Test on Reflectance Test Strips Refer to the instructions for use provided with your quality control materials. If Quality Control Results Are Not in Range IMPORTANT: Patient tests should not be performed until control results are within range. 1. Ensure test strip slot area is clean. 2. Make sure neither the test strips nor the controls are past the expiration date printed on the label. 3. Make sure the MEMo Chip matches the test strip lot. 4.
How to Obtain a Blood Sample from a Fingerstick A new pair of clean gloves should be worn by the user before testing each patient. 1. Use either the middle or ring finger for fingersticking. 2. Select the site to allow for convenient collection. 3. Clean the site with an alcohol wipe. 4. Apply gentle pressure to the finger with lancet and stick the finger left or right of center. 5. Gently apply pressure (squeeze and release) to the finger to produce a large drop of blood.
How to Run an Electrochemical Test 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 34 Insert correct MEMo Chip for the lot of strips in use. Insert MEMo Chip with lot number code facing down. Press either button to turn on the analyzer. Remove a single electrochemical test strip from the test strip vial and immediately replace the cap (if applicable). Insert the electrochemical test strip into the designated electrochemical test strip port. APPLY SAMPLE icon appears on the display.
9. For the reflectance test: a. After applying blood to the electrochemical test strip, wipe the finger to remove any blood with a clean piece of gauze. b. Gently, without force, apply pressure to the fingertip to accumulate a large drop of blood. (If venous blood is used, collect in an EDTA or heparin tube. Invert gently 5-7 times to mix completely. Collect sample with capillary tube or transfer pipet and touch to end of test strip.) Note: Excessive squeezing of the finger may alter test results. c.
How to Clear Results Stored in Memory 1. Press either button to turn on the analyzer. Wait for the display to read either INSTALL MEMO CHIP or INSERT STRIP. 2. Press Enter, then press Next until UTILITY is displayed. Press Enter. 3. Press Next until CLEAR MEMORY is displayed. Press Enter to clear memory. 4. To exit, press Next until the display reads EXIT, then press Enter. Press Next until you return to RUN TEST.
Wireless Compatibility • See Section 3, Setup for instructions on turning wireless connectivity on and off • Connecting to wireless requires additional setup specifications Contact PTS Diagnostics Customer Service for additional information. Data Management The CardioChek Plus analyzer is designed to connect to any IEEE 802.11b, 802.11g, or 802.11n network which uses the WPA Personal or WPA2 Personal network encryption schemes.
Frequency: Always clean after each use. Always clean and disinfect before storing and between each patient test. Please read the disinfectant manufacturer’s product label. Recommended Disinfectant: Super Sani-Cloth® wipes or any disinfectant with the same EPA Reg. No. (EPA Reg. No. 9480-4, Professional Disposables International, Inc. (PDI), Orangeburg, NY), concentration of active ingredients (0.25%) and with a contact time of 2 minutes.
Disinfection Instructions After cleaning, the next step is to disinfect. Always both clean and disinfect. 1. Using a fresh wipe, wring the wipe to remove excess liquid and wipe all areas thoroughly. 2. Keep area wet for 2 minutes to ensure disinfectant remains in contact for a sufficient time to kill all bloodborne pathogens. 3. Allow to air dry completely. Note: It is important that the analyzer be thoroughly dry before using. 4.
10 Troubleshooting Message or Issue 46 Probable Cause What to Do Message or Issue Probable Cause What to Do EXPIRED LOT Test strips are expired, wrong MEMo Check test strip expiration date and make sure correct MEMo Chip is inserted. Check date Chip is inserted, or date is not setting – see Section 3, Setup – How To Set set properly. the Date and Time. REPLACE BATTERIES Batteries need to be replaced. Replace all batteries with new high-quality AA batteries.
11 Interpreting Results 12 CLIA Information All test results must be assessed by a qualified medical professional. Depending on the analyte being assessed, high or low results may have medical consequences. General CLIA Information (US Only) If the result reads > (greater than) or < (less than) or results are not as expected, always repeat the test correctly with a new unused test strip. If a test result is displayed that is not expected, consult the following table.
13 Specifications CardioChek Plus Analyzer Calibration Curve: Input from MEMo Chip per test strip lot Batteries: (4) AA 1.5 volt alkaline Operating Temperature Range: 50-104°F (10-40°C) Note: The analyzer temperature must be within the test strip temperature specifications to function as a system. Humidity Range: Between 20 and 80% RH Dimensions: Width: 3.2 in (8.13 cm) Length: 6.0 in (15.24 cm) Height: 1.5 in (3.8 cm) Weight (without batteries): ~5.5 oz.
15 Warranty CardioChek Plus Analyzer Limited Two-Year Warranty PTS Diagnostics warrants to the original purchaser only, that the CardioChek Plus analyzer shall be free of any defects in materials or workmanship for a period of two years from the date of original purchase. Activation of this warranty shall be conditioned upon completion and return of the warranty registration card to PTS Diagnostics.
17 Index Analyzer Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Battery Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Blood Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Polymer Technology Systems, Inc. 7736 Zionsville Road, Indianapolis, IN 46268 USA Direct: +1-317-870-5610 · Toll-free inside the US: 1-877-870-5610 · Fax: +1-317-870-5608 Email: customerservice@ptsdiagnostics.com · Website: ptsdiagnostics.com MDSS GmbH Schiffgraben 41 30175 Hannover, Germany The CardioChek® Plus test system is covered by one or more patents. For details, refer to www.ptsdiagnostics.com/patents.html.
