BioSensory SD A1cCare - CHAPTER 10. Warnings, Precautions and Limitations; Warnings, Precautions, and Limitations

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CHAPTER 10. Warnings, Precautions and Limitations
1. SD A1cCare Test kit is only use for In-vitro diagnostic.
2. Carefully follow the instructions and procedures described in this insert before
testing.
3. SD A1cCare Test kit is only for professional use in hospitals, clinics and physician oce
laboratories.
4. Do not use SD A1cCare Test kit if its code number does not match with Code Chip that
is inserted into the analyzer.
5. SD A1cCare Test Set should remain in its original sealed pouch until ready to use. Do
not use the Test Set if the pouch is damaged or the seal is broken.
6. This Test Set is only for single use. Don't re-use it.
7. Severe hemolysis or patients who has hemolytic anemia, the blood sample
contaminated by microorganism are able to get the inaccurate results.
8. Extreme Hematocrit(below 25% or over 65%) may aect the test result.
9. Do not use frozen blood or the articial materials.
10. Do not use other anticoagulant (heparin, EDTA, Fluoride available).
11. After mix the blood sample and buer solution, immediately apply the sample at the
Test panel.
12. Before testing, check the latex-tablet(contamination or broken).
13. Use SD A1cCare System at the 15~32°C (59~89°F). Avoid using at the place
drastically changing environment temperature.
14. Put the analyzer at at place when testing.
15. If move the testing site, put the analyzer at the changed site for stabilization for 30
minutes before testing.
16. Wash your hands in warm, soapy water before collecting ngerstick blood. Rinse well
and dry completely before testing. If alcohol is used for cleansing, be sure the nger
is completely dry before lancing.
17. Discard the used Test kit according to the proper method.