Clinical Studies; Study Population - Covidien Nellcor GR101704-RR Operator's Manual

Nellcor™ Respiration Rate

Clinical Studies

1.11
Two (2) prospective, observational, non-randomized clinical studies were conduct-
ed to demonstrate the accuracy of Respiration Rate Version 2.0 when used in con-
junction with the Nellcor™ Bedside Respiratory Patient Monitoring System, using
the Nellcor™ Adult Respiratory Sensor. One study was performed with healthy
recruited volunteers at a single clinical laboratory. A second study enrolled volun-
teer subjects from a hospital population. Accuracy was established by comparison
to respiration rate determined from capnography waveforms.
Methods
1.11.1
Data from 105 enrolled subjects were included in the analysis: 30 healthy vol-
unteers and 75 hospitalized patients. Subjects were studied for approximately
30 minutes during which data from capnography and the Nellcor pulse oxim-
eter were collected. Respiration rate was derived every five seconds using Res-
piration Rate Version 2.0. The reference was obtained from counting breaths
on the capnography waveforms by an anesthesiologist blinded to all other
data.

Study Population

1.11.2
Demographics for all study subjects are presented in
ADD-28
Table 1-7. Nellcor™ Adult Respiratory Sensor Operating Range and Power Dissipation
Operating Range and Dissipation
Red Light Wavelength
Infrared Light Wavelength
Optical Output Power
Power Dissipation
Table 1-8. Demographic Data
Demographics
Age (Years)
Gender (Male/Female)
2
BMI (kg/m )
Approximately 660 nm
Approximately 900 nm
Less than 15 mW
52.5 mW
Table
Mean ± Standard Deviation (Range)
47.69 ± 17.94 (18 - 91)
60/45
29.15 ± 8.10 (17.22 - 55.91)
1-8.
Operator's Manual Addendum