NOVA BIOMEDICAL StatStrip 55848 - 1.3 Intended Use

1-5
1. Intro.
Instructions for Use Manual 1 Introduction
Disposal of Used Meters
• The meter may become infectious during the course
of use. Discard in accordance with local regulations
for biohazardous waste.
Chemical and Biological Safety
1. Observe all precautionary information printed on
the original solution containers.
2. Operate the meter in the appropriate environment.
3. Dispose of all waste solutions according to standard
hospital procedures.
Environmental
• The operating temperature range for Meter operation:
59˚Fto104˚F(15˚Cto40˚C)
• The relative humidity range for Meter operation: 10%
to 90% non-condensing
• The maximum altitude for Meter operation: Up to
15,000 feet (4500 meters)
Dimensions:
Height: 146 mm (5.8 in)
Width: 79 mm (3.1 in)
Depth: 30 mm (1.18 in)
Weight: 220 g (0.49 lb)
1.3 Intended Use
The StatStrip Glucose Hospital Meter System is intended for
point-of-care, in vitro diagnostic, multiple-patient use for the
quantitativedeterminationofglucoseincapillaryngerstick,
venous whole blood, arterial whole blood, neonate arterial
whole blood, and neonate heel stick specimens throughout
all hospital and all professional healthcare settings, including
patients receiving intensive medical intervention/therapy.
The system should only be used with single-use, auto-
disablinglancingdeviceswhenperformingacapillarynger
stick or neonate heel stick.
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 5 9/13/18 8:29 AM