5
Note:
1. The meter is 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 blood borne 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.
•
The system is tested to accurately read the measurement of glucose in
fresh capillary whole blood within the range of 20 to 600 mg/dL and
β-ketone in fresh capillary whole blood within the range of 0.1 to 8.0 mmol/L.
•
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 find out your
hematocrit level.
•
Patients undergoing oxygen therapy may cause 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 13123ft (4000 meters) above sea
level for blood glucose testing and 8700 ft (2651 meters) above sea level for
blood β-ketone testing.
•
Do not use when humidity is higher than 90% and lower than 10%, as
extremes in humidity may affect results.
•
For
in vitro
diagnosis use only.
•
The system 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.
