Accu-Chek Active User Manual page 63

Altitude
Dimensions
Weight
Display
Interface
Safety class
Electromagnetic
compatibility
Performance
analysis
Calibration and
traceability
The Accu‑Chek Active system meets the EN ISO 15197 requirements.
Technical data and system components
sea level to 4000 m
97.8 × 46.8 × 19.1 mm
without battery: approx. 46 g
with battery: approx. 50 g
96‑segment liquid crystal display (LCD)
USB (Micro B)
III
This blood glucose meter meets the electromagnetic immunity requirements
as per EN 61326‑2‑6 and EN ISO 15197 Annex A. The chosen basis for
electrostatic discharge immunity testing was basic standard IEC 61000‑4‑2.
In addition, it meets the electromagnetic emissions requirements as per EN
61326‑2‑6 and EN ISO 15197 Annex A. Its electromagnetic emission is thus
low. Interference on other electrically‑driven equipment is not anticipated.
The performance data for the Accu‑Chek Active system (Accu‑Chek Active
meter with Accu‑Chek Active test strips) was obtained using capillary blood
from diabetic patients (method comparison, accuracy), venous blood
(repeatability) and control solution (reproducibility).
The system (meter and test strips) is calibrated with venous blood containing
various glucose concentrations. The glucose values used as reference values,
and thereby also as accuracy values of this calibration, are obtained using the
hexokinase method. The hexokinase method is calibrated using the ID‑GCMS
method, which is the method of highest metrological quality (order) and is
traceable to a primary NIST standard. As the test results obtained using these
test strips can be traced back to the NIST standard using a traceability chain,
the test results obtained with these test strips for control solutions can also be
traced back to the NIST standard. This ensures that the metrological
traceability of the control solutions refers to higher order reference materials/
reference methods.
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