i
Blood Glucose Monitoring System
Dear
VivaChek™ Fad Sync System User,
Thank you for choosing the
VivaChek™ Fad Sync Blood Glucose Monitoring
System!
VivaChek™ Fad Sync Blood Glucose Monitoring System is designed for
easy test of blood glucose and helps you keep blood glucose under control.
Read this User’s Manual carefully before you use your meter system. This manual
will help you to get comfortable using the
VivaChek™ Fad Sync Blood Glucose
Monitoring System
and get reliable test results. Please keep your User’s Manual in
a safe place; you may want to refer it in the future.
Thank you again for choosing the
VivaChek™ Fad Sync System.
Intended Use and Principle
VivaChek™ Fad Sync Blood Glucose Monitoring System is comprised of the
VivaChek™ Fad Sync Blood Glucose Meter (VGM08) and the VivaChek™ Ino
Blood Glucose Test Strips (VGS01) and
VivaChek™ Fad Blood Glucose Test
Strips (VGS02)
. The VivaChek™ Fad Sync Blood Glucose Monitoring System is
intended to quantitatively measure the glucose concentration in fresh capillary
whole blood samples drawn from the fingertips. It is intended for use by persons
with diabetes at home as an aid to monitor the effectiveness of diabetes control. It
is not intended for neonatal use or for the diagnosis of or screening for diabetes.
This system is intended for self-testing outside the body (in vitro diagnostic use)
and should only be used by a single person and should not be shared.
This 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. Use of this meter on multiple patients may
lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus
(HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
