In an individual's SpO2 range from 100 to 73 %, this study calibrates and evaluates the accuracy of SpO2 measurement by CW2 in comparison to reference pulse oximeter (Nellcor PM10) or CO-oximetry, Pulse rate (PR) and respiratory rate (RR) were calibrated based on the same Nellcor equipment and the frequency of end-tidal CO2 respectively.
The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 80601-2-61:2017, Corrected version 2018-02 and ISO 80601-2-55. SpO2: Testing to confirm the accuracy of the SpO2 monitoring according to ISO 80601-2-61 Clause 201.12.1.101 201.12.1.101 RR Testing: Testing to confirm the accuracy of the respiration rate monitoring according to ISO 80601-2-55. Volunteers respirated spontaneously, no efforts were made to include all ranges of respiration during the study. PR Testing: Testing to confirm the accuracy of the PR monitoring according to ISO 80601-2-61 Clause 201.12.1.104. No efforts were made to influence PRs of volunteers. An accelerometer and PPG filters are built in CW2 in order to form the basis to exclude non-eligible test results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
12
CardioWatch 287-2 (CW2 Test Device or CW2). This medical device is based on the precursor CardioWatch 287-1 approved by EU-MDR under number 20M00011CRT01, CW2 has two red, two infrared and two green LEDs, and two photosensors compared to its precursor.
Complementair Medisch Centrum (CMC) Europe
Genk, Belgium
Pulse Oximetry
SpO2
Time frame: 1 hour
Pulse rate
Heart rate in beats per minutes
Time frame: 1 hour
Respiratory rate
In breaths per minutes
Time frame: 1 hour
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