A-2
StatStrip Glucose Hospital Meter
Weight: 220 grams (0.49 lb)
Power: 3.7V Li Polymer battery
(Rechargeable/Replaceable)
Environmental:
Temperature range 59°F - 104°F (15°C - 40°C)
Altitude Up to 15,000 feet (4500 meters)
Relative Humidity Up to 90% (noncondensing)
Chemistry Measurement
The typical imprecision for glucose both for within-
run and day-to-day
Glucose Levels Glucose Levels CV%
(mg/dL) (mmol/L)
50 2.8 8%
150 8.3 6%
400 22.2 4%
600 33.3 4%
A.2 Controls/Linearity Solutions
This section covers the solutions required for the StatStrip
Glucose Hospital Meter.
Solutions to be used by the Meter:
1. Three levels of Nova QC Solutions:
Level 1, Level 2, and Level 3
2. Five levels of Nova Linearity Solutions (values for
the full reportable range of meter linearity): Levels
1, 2, 3, 4, and 5
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 2 9/13/18 8:29 AM
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