MHC Medical Products EasyTouch BluLink, Инструкция по эксплуатации

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capillary whole blood samples may be drawn from the fingertips, ventral palm,
dorsal hand, upper arm, forearm, calf and thigh.
The EasyTouch® BluLink® Glucose Control Solutions are for use with the
EasyTouch® BluLink® Meter and EasyTouch® BluLink® Test Strips to check that
the meter and test strips are working together properly and the test is
performing correctly.
The GlucoDiary is a PC-based software intended for use in home to help people
with diabetes in the review, analysis and evaluation of glucose test results
for effective diabetes management. It is intended for use as an accessory to
EasyTouch® BluLink® Blood Glucose Monitoring System.
Important Information
The EasyTouch® BluLink® Blood Glucose Monitoring System provides a quick and
easy way for patients with diabetes to measure their blood sugar levels.
It should only be used with fresh capillary whole blood samples. It is designed for
in-vitro diagnostics use only and should not be used for any purpose other than
monitoring blood sugar levels. It should not be used for the diagnosis of diabetes
or for the testing of newborns (neonates).
WARNING:
Do not change your medication based on the EasyTouch® BluLink® meter test
results without contacting your Physician or Healthcare Professional.
Important Safety Instructions
The Centers for Disease Control and Prevention (CDC) and the US Food and Drug
Administration (FDA) have become increasingly concerned about the risks for
transmitting hepatitis B virus (HBV) and other bloodborne pathogens to people
undergoing finger stick procedures for blood sampling. For instance, people with
diabetes who require assistance monitoring their blood glucose levels.
Reports of HBV infection outbreaks linked to diabetes care have been increasing.
This notice serves as a reminder that finger stick devices should never be used for
more than one person.