Important Safety Instructions; Read Before Use; Intended Use - Fora Diamond Mini Owner's Manual

IMPORTANT SAFETY INSTRUCTIONS

READ BEFORE USE

Dear owners of FORA Diamond MINI Blood Glucose Monitoring System,
The system consists of three main products: the meter, test strips and
control solutions. These products have been designed, tested, and proven
to work together as a system to produce accurate blood glucose test
results. Only use FORA Diamond MINI test strips and control solutions
with the FORA Diamond MINI Blood Glucose Monitoring System.

INTENDED USE

This system is intended for external use (in vitro diagnostic use) only.
It is used for the quantitative measurement of glucose in samples of
venous whole blood and fresh capillary whole blood taken from the palm,
forearm, upper arm, calf, thigh, or fingers. It is not intended to diagnose
or screen for diabetes mellitus, or to be used on neonates.
Professionals may test with capillary and venous blood sample; home
use is limited to capillary whole blood testing. Use only heparin for
anticoagulation of whole blood.
This system provides you with plasma equivalent results.
The measurement unit used for indicating the concentration of blood or
plasma glucose can either have a weight dimension (mg/dL) or a molarity
(mmol/L). The approximate calculation rule for conversion of mg/dL in
mmol/L is:
mg/dL
mmol/L
4
Divided by 18
Times 18
For example;
= mmol/L
1) 120 mg/dL ÷ 18 = 6.6 mmol/L
= mg/dL
2) 7.2 mmol/L x 18 = 129 mg/dL
approximately.