Instructions for use

these instructions for use are supplied electronically, paper format is available upon request at support\@intelliprove com these instructions for use apply to version 1 0 0 of the intelliprove product product label product description 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 intended use see intended use docid\ ll6fhdmodw8lce9xfduct clinical benefit intelliprove is a software based technology which allows a simple, fast, user friendly and contactless use for acquiring physiological and behavioural signals of a patient or subject in the healthcare setting performance characteristics 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 contraindications 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 tips and recommendations 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 ✅ 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, a ' quality check ', prior to each health check most of the above conditions will be checked during this check warnings ❌ 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 (or immediately after) 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 compatibility refer to our product documentation system requirements docid\ auf fxkb5ekyvygzuz4g3 benefit and performance claims 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 disclaimers intelliprove is not intended to be utilized to diagnose, treat, cure or prevent any disease, ailment, or injury the advice resulting from this health check is not a substitute for a consultation with a general practitioner or other medical specialist if you have any complaints or doubts about your health, always consult a doctor or other professional care provider applicable symbols incident reporting in case any serious incident occurs in relation to intelliprove, this should be reported to your intelliprove representative and the component authority of your country manufacturer intelliprove bv d’haenestraat 22, 9070 heusden, belgium document history document history version change no description of the change author date 1 0 1 first edition joeri tulkens 19/12/2023