VivaChek Fad Sync - System Limitations and Biohazard Risks

4
• Use only VivaChek™ Ino/Fad test strip with your VivaChek™ Fad Sync
meter.
• Use only VivaChek™ Ino/Fad control solution with your VivaChek™ Fad
Sync meter and VivaChek™ Ino/Fad strip.
• Please contact your physician or diabetes healthcare professional if you
determine to make a change on your current medical therapy or diet activity
based on test results.
• If the system is used in a manner not specified by the manufacturer,
the protection provided by the system can be impaired.
Potential Biohazard
All parts of the kit are considered biohazardous and can potentially transmit
infectious diseases, even after you have performed cleaning and disinfection.
Note:
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 blood borne pathogens, even after you have
performed cleaning and disinfection. Please follow proper precautions when
handling your meter and lancing device.
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.
• When using with VivaChek™ Fad test strips, very high (above 70%)
hematocrit levels can cause false results.
• When using with VivaChek™ Ino test strips, very high (above 70%) and
very low (below 20%) hematocrit levels can cause false results. Talk to your
health care professional to find out your hematocrit level.
• If you are taking vitamin C (ascorbic acid in your blood > 3 mg/dL) then your
glucose results using this meter may not be reliable.
• Patients undergoing oxygen therapy may cause false result.
• Not for use on patients with critical illness.
• Not for use on patients in shock, or with severe dehydration or from patients