RespiraSense
™
Instructions For Use
RespiraSense
™
PDS-801-007 Revision 2
Page
59
of
77
Compliance
The following table shows the compliance specifications.
EMC Compliance
EN 60601-1-2, Class B
Equipment classification
IEC 60601-1
Type of protection
Internally-powered (battery-powered)
Degree of protection
–
patient
Type BF-applied part
Mode of operation
Continuous
Ingress protection
IP54
Medical RS Device Directive 93/42/EEC: 2007
Class IIb medical Device
Respiratory Rate Measurement Limits
The Respirator Rate Measurement Limits declared for the RR Monitor are show in
Table 13:
Measurement Limits
. The statistics are based on a comparison against capnography using the Bland
Altman technique and apply to the 2, 5- and 15-minute averaging timeframe.
Table 13: Measurement Limits
Measurement
Bias (bpm)
-1 <= Bias < 1
Upper Limit of Agreement
<= 3
Lower Limit of Agreement
>= -3
Calculation Range
6
–
60 bpm
Resolution
1 bpm
CAUTION
Excessive movement can render the results from the device inaccurate.
Non-Invasive and Continuous Respiratory Rate Monitoring Compared to Electrocardiogram and
Nurse Evaluation
In 41 comparisons between a prototype version of the RespiraSense
™
Respiratory Rate Monitor,
electrocardiogram and nurse visual observations, the RR accuracy was as shown
in
Table 14: Clinical Evaluation Summary of
Results (Lee P, "Clinical evaluation of a novel respiratory rate
. 2016 Apr;30(2):175-83).
