1
Chapter 1
Introduction
Introduction
Please read carefully before using meter kit, and consult healthcare professional before
making any important medical decision. Please contact your local customer service for further
assistance with the product.
Normal Environmental Conditions
This meter designed under the following conditions:
• Indoor use • Overvoltage category II • Pollution degree 2
Electromagnetic Compatibility
This meter meets the electromagnetic compatibility, emission, and immunity, and the
requirements of IEC 61326-2-6.
Intended Use
BeneCheck Knight Blood Glucose & β-Ketone Monitoring System is only for
in vitro
diagnostic
use which is used for quantitative measurement of blood glucose or β-Ketone level in fresh
capillary whole blood as aid in monitoring diabetes management at home or in clinical
settings. Alternative site for glucose testing is allowed (fingertip, palm & forearm).
Fresh venous or artery whole blood drawn by healthcare professionals can be used only for
testing blood glucose, not for the diagnosis.
Principles of the Examination Method
• Electrochemical Biosensor.
The meter is plasma-calibrated by reference instruments, which are traceable to the following
standard reference materials and methods.
Test
Standard
Method
Glucose
NIST SRM 917
Glucose Dehydrogenase
β-Ketone
internal master calibrator UV
