59
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
guidance
Radiated RF IEC 61000-
4-3
385 MHz 27 V/m
450 MHz 28 V/m
710 MHz 9 V/m
745 MHz 9 V/m
780 MHz 9 V/m
810 MHz 28 V/m
870 MHz 28 V/m
930 MHz 28 V/m
1720 MHz
28 V/m
1845 MHz
28 V/m
1970 MHz
28 V/m
2450 MHz
28 V/m
5240 MHz
9 V/m
5500 MHz
9 V/m
5785 MHz
9 V/m
385 MHz 27 V/m
450 MHz 28 V/m
710 MHz 9 V/m
745 MHz 9 V/m
780 MHz 9 V/m
810 MHz 28 V/m
870 MHz 28 V/m
930 MHz 28 V/m
1720 MHz
28 V/m
1845 MHz
28 V/m
1970 MHz
28 V/m
2450 MHz
28 V/m
5240 MHz
9 V/m
5500 MHz
9 V/m
5785 MHz
9 V/m
The FeNObreath™ Monitor is
suitable for the electromagnetic
environment of typical
commercial or hospital settings.
Summary of the clinical data
Study 1: A clinical Precision study comparing intra and inter usability of FeNO measurement using
the FeNObreath™.
In one of the studies conducted, the clinical precision, as it relates to user bias of the FeNObreath™,
was evaluated in a mixed study population of 76 participants - including 24 pediatric participants
(ages 7-17 years) and 52 adults (18 years+). Participants were asked to obtain 2 FeNObreath™
measurements with the assistance of 3 health care professionals (HCPs), for a total of 6
FeNObreath™ evaluations per participant.
The clinical precision study was designed to capture the accuracy and precision of the FeNObreath™
device, therefore FeNO values acquired by subjects covered potential FeNO values which would be
observed in clinical practice. The within subject precision* was assessed from this study population
and is presented in the table below:
Median
Concentrations
N
Within Subject
Mean SD (ppb)
Within Subject
Mean CV (%)
95% CI for CV (%)
0 to <10
10
0.8034172
13.35%
7.85%; 18.85%
10 to <20
21
1.2430966
9.18%
6.73%; 11.64%
20 to <30
23
0.9720727
4.17%
2.48%; 5.85%
30 to <40
5
1.2279205
3.65%
1.3%; 6%
40 to <50
5
1.3867462
3.17%
0.23%; 6.1%
>=50
12
1.4078969
1.89%
1.29%; 2.48%
