Limitations
The Tyson Bio HS200-B Blood Glucose Monitoring System give accurate results when the following limitations are observed.
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Use only capillary whole blood from finger, palm, and forearm.
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Do not use for testing neonatal blood.
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Altitude higher than 10745 feet may cause inaccurate results.
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Severe dehydration and excessive water loss may lead to inaccurate blood glucose test results.
Consult your physician immediately if you believe you are suffering from severe dehydration.
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For single-patient use only and should not be shared.
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Should not be used to test critically ill patients.
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Inaccurate results may occur in severely hypotensive individuals or patients in shock.
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Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
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For In vitro diagnostic only.
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For over the counter use.
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Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly).
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Alternative site measurements should never be used to calibrate continuous glucose monitors (CGMs).
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Alternative site measurements should never be used for insulin dosing calculations.
Warning
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This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term
care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as
part of glycemic control procedures.
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Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
