Intended Use - Fora D40 Serie Manual Del Propietário

Intended Use

FORA D40 Blood Glucose plus Blood Pressure Monitoring System is
intended to be used for the quantitative measurement of glucose (sugar)
in fresh capillary whole blood samples drawn from the fingertips, palm,
forearm, and upper arm. This system is intended to be used by a single
person and should not be shared.
The system is intended for self testing outside the body (in vitro
diagnostic use) at home. This system should not be used for the
diagnosis of or screening for diabetes, nor for neonatal use.
Alternative site testing should be done only during steady – state times
(when glucose is not changing rapidly).
This system is also intended to be used as a non-invasive measuring
system of systolic and diastolic blood pressure and pulse rate of an
adult individual at home. The blood pressure is measured by using an
inflatable cuff wrapped around the arm.
The meter contains some speaking functions but it has not been
validated for use by visually impaired users.
9