OPTi CCA-TS2 - 1 Introduction; Intended Use; Principles of Operation

Operator’s Manual – OPTI CCA-TS2 1-1
1 INTRODUCTION
1 INTRODUCTION
1.1 Intended Use
The OPTI™ CCA-TS2 Critical Care Analyzer is intended to be used for the measurement of
hydrogen ion concentration (pH), carbon dioxide partial pressure (PCO
2
), oxygen partial pressure
(PO
2
), sodium (Na
+
), potassium (K
+
), ionized calcium (Ca
++
), chloride (Cl
-
), glucose (Glu), blood
urea nitrogen (BUN/urea), lactate (Lac), total hemoglobin concentration (tHb) and hemoglobin
oxygen saturation (SO
2
) in samples of whole blood, and pH, sodium, potassium, ionized calcium,
chloride, glucose and BUN (urea) in serum and plasma, in either a traditional blood gas, clinical
laboratory setting or point-of-care locations by personnel minimally qualied to perform and
report these results.
The table below provides important information regarding supported sample types, available
reporting units and analyzer measurement ranges for each parameter.
Sample Type Available Units Measurement
Range
Display
Resolution
Parameter Whole
blood
Plasma Serum Default Other (Default Units) (Lo/Hi)
pH x x x pH units 6.6 - 7.8 0.01/0.001
PCO
2
x mmHg kPa 10 - 200 1/0.1
PO
2
x mmHg kPa 10 - 700 1/0.1
Na
+
x x x mmol/L mg/dL 100 - 180 1/0.1
K
+
x x x mmol/L mg/dL 0.8 - 9.99 0.1/0.01
Ca
++
x x x mmol/L mg/dL 0.2 - 3.0 0.01
Cl
-
x x x mmol/L mg/dL 50 - 160 1/0.1
Glu x x x mg/dL mmol/L 30-400 / 1.7-22 1/0.1
BUN/urea x x x mg/dL mmol/L 2.8-112.0 / 1-40 0.1/0.01
Lac x mmol/L mg/dL 0.3 - 17.5 0.01/0.01
tHb x g/dL mmol/L, g/L 5 - 25 0.1
SO
2
x % 60 - 100 1/0.1
1.2 Principles of Operation
The OPTI CCA-TS2 is a microprocessor-controlled medical instrument measuring optical
uorescence from discrete sensors called optical electrodes (optodes).
A disposable, single-use cassette contains all of the elements needed for calibration, sample
measurement and waste containment. Specic calibration information from the cassette is
scanned into the analyzer by holding the cassette package in front of the bar code scanner.
The cassette is then placed into the measurement chamber.
The analyzer warms the cassette to 37.0 ± 0.1 °C (98.6 ± 0.1 °F), and performs a calibration
verication on the sensors for PCO
2
and PO
2
by passing a precision calibration gas mixture
across the optode sensors. The pH and electrolyte channels are calibrated with precision buffer
solution contained in the cassette. The tHb and SO
2
channels are factory-calibrated.