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1. The meter and lancing device are for single patient use. Do not share them with
anyone including other family members! Do not use on multiple patients!
2. All parts of the kit are considered biohazardous. They can potentially transmit
infectious diseases from bloodborne pathogens, even after you have
performed cleaning and disinfection. Please follow proper precautions when
handling your meter.
3. For more information, please refer to the FDA Public Health Notification: “Use
of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication” (2010) at
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
You may also refer to the CDC Clinical Reminder: “Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010) at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
Limitations
• For single patient use only.
• Very high (above 70%) and very low (below 20%) hematocrit levels can cause
false results for blood glucose testing, and very high (above 65%) and very low
(below 20%) hematocrit levels can cause false results for blood β-ketone
testing. Talk to your healthcare professional to understand your hematocrit
level.
• Do not use this system if you are taking vitamin C (ascorbic acid in your blood >
3 mg/dL) since it could cause your glucose and ketone results to be incorrect.
• Patients undergoing oxygen therapy may produce false results.
• Severe dehydration (excessive water loss) may cause inaccurate results.
• Not for neonatal use.
• Not for use on patients with critical illness.
• Not for use in severely hypotensive individuals or on patients in shock or in a
hyperosmolar state.
• Not for screening or diagnosis of diabetes.
• Do not use the system at altitudes above 13,123ft (4,000 meters) above sea
level for testing.
• Do not use when humidity is higher than 90% and lower than 10%, as extremes
in humidity may affect results.
• For in vitro diagnostic use only.
• The meter 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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