Vital Signs Camera Medical Library

VitalSigns Camera Medical library is a software library that can be integrated
into a customer application for use during virtual consults or health
screening. It is intended for a point in time measurement/spot check of Pulse
Rate (PR) and Respiration Rate (RR) in an automatic contactless manner as a
data point in the overall assessment of the patient. It can be used either in
the home or in a clinical environment, when the person is still and positioned
properly in front of the camera, which is placed on a stable surface in an
adequately lit environment. Both PR and RR are measured simultaneously on the
same video data.
Remote photoplethysmography (rPPG) is a technique that measures a blood
pulsation signal on a piece of human skin tissue from an image sequence
recorded by a video camera. This blood pulsation signal is extracted by
analyzing minute color differences on the skin that are caused by blood volume
variations induced by each heart beat. These color differences are not visible
to the naked eye. VSC-MEDlib uses advanced image and signal processing
algorithms to measure the blood pulsation signal on the facial skin tissue of a
human subject and derive the subject*s pulse rate (PR). Respiration rate (RR)
is extracted from the same sequence of video images by analyzing the motion of
the human subject*s torso induced by respiratory movement.

VSC-MEDlib should be used by original equipment manufacturers and system
integrators for calculating a single HR and RR value, i.e., a spot check value,
from a video recording of a patient. Typically, a reliable HR and RR
measurement will be obtained within a recording duration of 1 minute.

VSC-MEDlib does not output PR or RR measurements that are of low confidence. As
described in the intended use, VSC-MEDlib should not be prescribed for persons
who do require critical care. It is not intended as a continuous patient
monitoring system or as the sole method of checking the physical health of the
patient, but as a part of a framework which mandates periodic checks by a
healthcare professional to ensure appropriate clinical diagnosis and treatment
can be reached. If an accurate pulse rate and respiration rate reading cannot
be obtained during the measurement, the healthcare professional should direct
the patient to report to a doctor*s office or other healthcare location to
obtain measurements for pulse rate and respiration rate via traditional
methods.

For a more detailed description of the investigational device including safety
precautions and handling, see the Instructions for Use. This study will be
performed to provide evidence for the claims as stated in the IFU and to show
that our risk mitigation works for use cases outside of our intended use.

During this study the influence of different suboptimal condition on the
recording by the VSC-MEDlib will be tested. The tests include the subjects
wearing make-up as this make-up might affect the rPPG signal and therefore the
PR measurement due to the fact that it reduces the amount of light penetrating
into and reflecting from the skin. Wearing sunglasses or a medical face mask
may affect this as well as they cover part of the face and may affect the
function of the face tracker. In another tests, the camera settings, the
minimum hardware requirements, the effect of a damaged lens of the smartphone
used, and the effect when the subjects' face is outside the test frame will be
tested.

In addition to the measurements under sub-optimal conditions, heart rate and
respiration are also measured after heart rate and respiration have been
increased by an exercise test. The volunteer is asked to practice on a spinning
bike for 10 minutes, followed by a 20-minute rest period. During this rest
period, 10 video recordings of 1 minute each are made.

Primary objective:
• To assess the clinical safety and effectiveness of Pulse Rate (PR) and
Respiration Rate (RR) measured
with the VSC-MEDlib within the intended use compared to the gold-standard
reference devices.

Exploratory objective:
• To assess the clinical safety and effectiveness of Pulse Rate and Respiration
Rate measured with the
VSC-MEDlib during suboptimal circumstances (outside the scope of the intended
use), compared to the
gold-standard reference devices.

This study is a single center, prospective clinical investigation which is
balanced for gender, age, Body Mass Index (BMI) and skin color. The study will
be performed at the High Tech Campus 37, 5656 AE, Eindhoven, the Netherlands.
Simultaneous measurements of PR and RR on study participants will be collected
in conditions described in IFU [REF-1] and various suboptimal conditions. The
study participants will be recorded with the VSC demo app (together with a
compatible camera and computing hardware) and reference devices. PR and RR data
to be collected by the VSC demo app, will be post-processed after the clinical
investigation and compared with the reference devices. To compare the PR
measured from the VSC-MEDlib with the reference device, there is an three lead
ECG recording that will be executed with the Philips MP50 monitor. The ECG is
used to record the electrical activity of the heart which is directly
correlated to the heart rate (in BPM). To compare the RR measurement from the
VSC-MEDlib with the reference device, there is a capnography recording that
will be executed by an oral/nasal canula, which is connected to the Philips
Respironics LoFlo sidestream. Capnography is used to measure the CO2 level
during the expiratory phase and is directly correlated to the respiration rate
of the study participant. Persons who are willing to participate will be asked
to provide their consent.

Not applicable

Simultaneous measurements of PR and RR in study participants will be collected
under conditions described under various sub-optimal conditions (e.g. wearing
make-up, measuring with a broken lens). This is a total of 10 test/recordings.
Recordings from the study participants will be recorded by the VSC demo app and
reference devices. As described in this protocol, study participants are
requested to sit still for a maximum of 2 minutes per recording. Heart rate and
respiration data collected by the VSC demo app will be analyzed after the study
and compared to the reference devices.
In addition to the measurements under sub-optimal conditions, heart rate and
respiration are also measured after heart rate and respiration have been
increased by an exercise test. The volunteer is asked to practice on a spinning
bike for 10 minutes, followed by a 20-minute rest period. During this rest
period, 10 video recordings of 1 minute each are made. The entire examination
will take approximately 2 hours.

Potential risks associated with the study include:
1. Study participants use makeup that may cause skin irritation
2. Study participants use makeup that can cause cross-contamination
3. Study participants will be exposed to viruses during the clinical study
4. The exercise is too intense for the study participants, which may cause
syncope
5. The ECG electrodes used during the clinical examination cause skin irritation

The outcome of the risk analysis for this clinical trial, including the use of
the research equipment (VSC-MEDlib), is that the risks are acceptable. Due to
the non-invasive and non-contact measurement of the VSCMEDlib/VSC demo app, the
risks for the study participant lie in the external factors (e.g. make-up,
viruses). The conclusion is that these risks are mitigated where possible and
acceptable.