RespiraSense
™
Instructions For Use
RespiraSense
™
PDS-801-007 Revision 2
Page
60
of
77
Table 14: Clinical Evaluation Summary of Results
Measurement
ECG
Nurse Evaluations
Correlation
0.84
0.79
Mean Standard Deviation
[-0.72,-0.12]
[-2.78, -1.49]
Range of respiratory rates
8 - 24
Mean Age
52
Age Range
20 - 84
Sex
55% Male (45% Female)
Sensor Specification
The RS Device Sensor is a multilayer composite of medical grade adhesives and materials enclosing
the sensing element. Table 18 shows the Sensor’s specifications.
Table 15: Sensor Specification
Sensor Function
Specification
Shelf life
2 years from the date of manufacturer
Duration of Use
4-days
Biocompatibility
The adhesive based components are tested to Cytotoxicity (ISO
10993-5) and Irritation and Sensitization (ISO 10993-10).
Whereas the plastic-based components are tested to 10993-5
Frequency of Use
Single Use
Sterilisation
Non-Sterilised
The following table shows the Sensor patient profile specifications.
Sensor
Application
site
Sex
Weight
Duration
of use
Sterile
Colour
Sensor
Lat*
M/F
10-150 Kg
96 hours
No
Tan
* Lateral position adhered to bottom fixed rib with overlap of abdominal region.
The Sensor is an Applied Part under IEC 60601-1 2006 A1:2012.
Sensor Revision (See individual Sensor Label): PDS-503-001.
Use only Sensors with this part number with this IFU.
