User's Manual

CHAPTER 9. WARNINGS, PRECAUTIONS, AND LIMITATIONS
• Discard test strip after using. Strips are to be used once. Never re-use a test strip.
• Do not ingest.
1. Test Strip for Lipid
1) Make sure the code chip number matches the number indicated on the lipid test strip
package. Never use a code chip from a different lot.
2) Out-of-date or expired strips cannot be used in your test system. Check the expiration
date on the package or pouch.
3) Add the blood sample to the lipid test strip at once. Do not add blood to the same strip.
Test again with a new test strip and fresh blood sample.
4) Not intended for screening or diagnosis, or for use on neonates.
5) Never make significant changes to your healthcare program or ignore physical symptoms
without consulting with your healthcare provider.
6) The following hematocrit range does not affect the test result of each parameter:
• TC, TG: 30–55%
• HDL: 30–52%
2. Test Strip for Glucose
1) The SD LipidoCare Professional System is not designed to be a substitute for pathology
laboratory equipment, and it should not be used for the diagnosis of diabetes.
2) Extremes in hematocrit may affect test results. Hematocrit levels less than 20% may cause
falsely high readings. Hematocrit levels greater than 60% may cause falsely low readings.
3) Not intended for screening or diagnosis, or for use on neonates.
4) Never make significant changes to your diabetes control program or ignore physical
symptoms without consulting with your healthcare provider.
5) Severe dehydration (excessive water loss) may cause false low results. If you believe you
are suffering from dehydration, consult your healthcare professional right away.
6) Inaccurate results may occur in severely hypotensive individuals or patients in shock.
Inaccurate results may occur for individuals experiencing a hyperglycemic hyperosmolar
state, with or without ketosis.
7) This device has not been evaluated in critically ill patients
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