Intended Use, Tests Performed, And Clinical Utility - NOVA BIOMEDICAL Stat Profile PRIME Instructions For Use Manual

Operate at Altitude:
• up to 12,000 feet/3650 meters
Dimensions:
Height:
Width:
Depth:
Weight:
17.5 lb (8.164 kg) without reagent pack
23 lb (10.45 kg) with full reagent pack
Lifting the Analyzer:
1. One person is needed to lift the analyzer.
CAUTION: Never use the door (open or closed) to assist
you in lifting the analyzer. The door cannot
support the weight of the analyzer.
2. From the front of the analyzer, place your hands
under each side of the analyzer.
3. Lift the analyzer. Remember to bend your knees
and lift with your legs and not your back.
4. Place the analyzer onto a clean and flat surface.

1.5 Intended Use, Tests Performed, and Clinical Utility

Intended Use
The Stat Profile Prime CCS Analyzer System is intended
for in vitro diagnostic use by health care professionals in
clinical laboratory settings for the quantitative determination
of pH, PCO
2
Lac (Lactate) in heparinized whole blood. It is not intended
for Point of Care use.
Measured Parameters
Stat Profile Prime CCS Analyzer: pH, PCO
+ + -
Na , K , Cl
Glucose and Lactate are optional.
15.4 in (39.1 cm)
12.0 in (30.5 cm)
14.4 in (36.2 cm)
+
, PO , Hct, Na , K
2
, iCa, Glu (Glucose), and Lac (Lactate)
1 Introduction
+ -
, Cl , iCa, Glu (Glucose), and
, PO , Hct,
2 2
1-5