Instructions for use
These instructions for use are supplied electronically, paper format is available upon request at email@example.com.
These instructions for use apply to version 1.0.0 of the IntelliProve product.
The IntelliProve device is a software that detects the blood flow in the face using the camera of a mobile device to acquire physiological and behavioural signals through innovative signal processing and machine learning techniques.
See Intended use.
How to properly perform the health scan?
Open the platform - website or mobile app - through which you are accessing IntelliProve's product and click on the button to start a health scan.
In order to ensure a good health scan, your face and upper-chest should be placed within the indicatory brackets on the recording screen, in such a way that the your face and upper chest are clearly visible.
Indicatory brackets and advised framing:
Before starting the scan, make sure following checks are positive.
✅ Take a seated position.
✅ Align and center your face and shoulders within the indicated area.
✅ Hold the smart device steady.
✅ Make sure the lighting is constant and your face is evenly illuminated.
✅ Make sure your camera lens is clean.
✅ Attempt to have a static background, e.g. reduce moving objects or people walking in the background.
IntelliProve performs a check of the measurement setup prior to each health scan. Most of the above conditions will be checked during this condition check (see API docs > check conditions).
❌ Do not perform health scans when the camera lens is unclean or broken.
❌ Health scans can’t be performed without internet connection.
❌ Do not perform health scans while driving or during physical activity.
❌ Do not use in poor lighting conditions.
❌ Do not talk or move during the measurement. This can interrupt the health scan or influence the quality of the health scan. In both cases, the health scan will have to be performed again.
IntelliProve is not intended to be used by all individuals:
ℹ️ People with inked face (i.e. tattoos, ink).
ℹ️ People under the age of 18 years.
ℹ️ People with reduced blood flow in the face as IntelliProve will not be able to detect the significant intensity variations induced by the blood flow.
ℹ️ People with conditions causing tremors or the inability to hold their face still for at least 30 seconds (e.g. Parkinson or dementia) as, in this case, IntelliProve cannot perform an accurate health scan.
ℹ️ People that have a disability limiting them to perform the health scan according to the instructions for use.
Refer to our product documentation: System requirements
The IntelliProve software is fast, user-friendly, contactless and does not need any additional medical equipment or wearables.
At least 90% of the acquired signals should have:
- Excellent peaks (i.e. systolic and diastolic waves/dicrotic notches are salient)
- Root Mean Square of Successive Differences (rMSSD): <300
- Standard deviation of the amplitudes (STDA): <0,30
- Difference SDNN, reference device versus IntelliProve: <40
- Difference beats per minute, reference device versus IntelliProve: <5
In case any serious incident occurs in relation to IntelliProve, this should be reported to your Synbase representative and the component authority of your country.
D’Haenestraat 22, 9070 Heusden, Belgium