Rad-97
Chapter 11: Specifications
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Carboxyhemoglobin Level (SpCO) [1]
Range of 1% to 40%
Adults, Pediatrics, Infants 3%
Methemoglobin Level (SpMet) [1]
Range 1% to 15%
All patient populations
1%
Total Hemoglobin (SpHb) [7]
Range of 8 g/dL to 17 g/dL Adults, Pediatrics
1 g/dL
Respiratory Rate (RRa) [8]
Range of 4 to 70 bpm*** Adults, Pediatrics
1 bpm
Respiratory Rate (RRp)**** [8]
Range of 4 to 70 rpm
Adults, Pediatrics
1 rpm
* A
RMS
accuracy is a statistical calculation of the difference between device measurements and
reference measurements. Approximately two-thirds of the device measurements fell within
+/- A
RMS
of the reference measurements in a controlled study.
** See Bland and Altman. Agreement between methods of measurement with multiple
observations per individual.
Journal of Biopharmaceutical Statistics
(2007) vol. 17 pp.
571-582.
*** Breaths per minute is denoted as rpm on device display.
****Parameter currently not available in the U.S.A. and territories relying on FDA market
clearance.
Note:
A functional tester cannot be used to assess the accuracy of Rad-97.
