Pulse Oximeter Calibration
Conditions
Brief summary
Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead. 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- 2-61:2011)
Interventions
DEVICENightOwl
The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived
Sponsors
Ectosense NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score)
Exclusion criteria
* smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels. * individuals subject to conditions that result in elevated levels of methaemoglobin. * individuals with arterial cannulation or hypoxia at FiO2 = 0,21
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A_rms determination | Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed. | After calibration of the NightOwl SpO2 software module, the A\_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark. |
Countries
Belgium
Contacts
Primary ContactFrederik Roger Massie, ir
Outcome results
None listed