Table of Contents
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Procedure: CardioChek® Plus Test System/PTS
Panels® Lipid + eGLU™ Smart Bundle™ Test Strips
Approved
Director: _____________________________________________
Signature
Prepared by Date: ________________
Supersedes Procedure: _________________________
Review Date: ___________________________
Reviewed By: _______________________________________________________
Signature
Distribution List: ____________________________________________________
Number of Copies: ________________
Date
Adopted Date: _________________
Date
LIT 001659 Rev. 0 4/14
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Table of Contents
Related Manuals for CardioChek PLUS
Summary of Contents for CardioChek PLUS
- Page 1 Procedure: CardioChek® Plus Test System/PTS Panels® Lipid + eGLU™ Smart Bundle™ Test Strips Approved Director: _____________________________________________ Signature Date Prepared by Date: ________________ Adopted Date: _________________ Supersedes Procedure: _________________________ Review Date: ___________________________ Reviewed By: _______________________________________________________ Signature Date Distribution List: ____________________________________________________ Number of Copies: ________________...
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Page 2: Table Of Contents
Table of Contents Purpose ............................4 Principle ............................4 A. The CardioChek Plus Test System ..................... 4 B. Test Strips ..........................4 C. The MEMo Chip ........................4 Guidelines for Using the MEMo Chip ..................5 III. Specimen Collection ........................5 A. - Page 3 When to Replace the Batteries ....................14 How to Install/Replace the Batteries ..................14 References ........................... 15 Refer to the CardioChek® Plus User Guide and the PTS Panels® Lipid Panel and eGLU™ test strips package inserts for complete instructions for instrument and test performance.
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Page 4: Purpose
(venous or fingerstick) with the other PTS Panels (reflectance) test strips. Principle The CardioChek Plus test system consists of three main parts, including the analyzer, the PTS Panels test strips, and the MEMo Chip®. A. The CardioChek Plus Test System The CardioChek Plus test system uses reflectance photometry and electrochemical biosensor technology. -
Page 5: Guidelines For Using The Memo Chip
MEMo Chip is inserted into the port with the finger notch facing up. The MEMo Chip reads the test strip expiration date, tells the analyzer which test(s) to run, contains the calibration curve and the lot number for the specific test strip lot, controls test sequences and timing, and establishes the measuring range for the test. -
Page 6: Venous Whole Blood Samples
5. Gently apply pressure to the finger near the first knuckle of the ring or middle finger and engorge the end of the finger with a squeeze and release technique. 6. Use the first drop of blood to immediately dose the tip of the eGLU test strip until the channel is filled and the screen shows a beating heart icon over the glucose strip. -
Page 7: Equipment
A. Equipment 1. CardioChek® Plus analyzer B. Materials 1. A Smart Bundle pack consisting of 3 vials of reflectance Lipid Panel test strips and 1 vial of electrochemical eGLU test strips. 2. 1 MEMo Chip® per test strip box (contains lot-specific test strip information) 3. -
Page 8: Use Of The Check Strips
Quality Control requirements. A. Use of the Check Strips The gray check strips (included in the analyzer carrying case) verify that the CardioChek Plus analyzer's electronic and optical systems are functioning properly. Each check strip is calibrated to read a specific reflectance. -
Page 9: How To Use Pts Panels Multi-Chemistry Controls
How to Use PTS Panels Multi-Chemistry Controls With the MEMo Chip out, press any button to turn CardioChek Plus device on. 2. When INSERT MEMO CHIP appears on the screen, press NEXT until display reads UTILITY. 3. Press the ENTER button once, then the NEXT button once to see RUN CONTROL, then press ENTER. -
Page 10: How To Use Pts Panels Hdl Cholesterol Controls
+1-877-870-5610 (toll-free inside the U.S. and Canada) or +1-317-870-5610. How to Use PTS Panels HDL Cholesterol Controls 1. With the MEMo Chip out, press any button to turn CardioChek Plus device on. 2. When INSERT MEMO CHIP appears on the screen, press NEXT until display reads UTILITY. -
Page 11: Expected Results
Immediately replace the vial caps, making sure the test strip vials are capped tightly. The CardioChek Plus analyzer will display APPLY SAMPLE with a blood drop icon over the eGLU test strip. This indicates the system is ready for a sample (control) to be applied to the eGLU test strip first. -
Page 12: Expected Results
8. The blood drop should be a large drop at the fingerstick site to touch the tip of the capillary tube. With 2 to 3 squeeze-and-release motions, allow the horizontal fill of the capillary tube without the introduction of bubbles or air spaces. When the blood drop icon is over the Lipid Panel test strip, use the filled capillary tube and plunger to hover over the blood application window of the test strip and deposit the entire sample onto the blood application window while hovering. -
Page 13: Procedural Notes
VIII. Procedural Notes For in vitro diagnostic use. PTS Panels® Lipid + eGLU™ Smart Bundle™ test strips can only be used in the CardioChek® Plus analyzer. Recap strip vial immediately and tightly after removing a single test strip. -
Page 14: Cleaning Instructions
How to Install/Replace the Batteries 1. 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. -
Page 15: References
References 1. ATP III NCEP Guidelines for CHD Risk. JAMA. 2001. 285:2486-2509. 2. Castelli, WP, et al. Circulation 1983. 67(4): 730-734. 3. Clinical Diagnosis and Management by Laboratory Methods, Eighteenth Edition, John Bernard Henry, Editor, W.B. Saunders Company, Philadelphia, 1991. 4.