Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate

Inclusion Criteria:

• Healthy subjects with ASA health score of I or II

• Subjects aged between ≥ 18 and ≤ 65 years.

• Subjects who have provided informed consent and are willing to comply with the studyprocedures.

Exclusion Criteria:

• Heavy smokers or individuals exposed to high levels of carbon monoxide resulting inelevated carboxyhemoglobin levels.

• Individuals with conditions that result in elevated methemoglobin levels.

• Individuals with hypoxia (SpO2 < 95% at 21% O2).

• Severe claustrophobia.

• Subjects known with altitude sickness.

• Subjects who are obese (BMI ≥ 35 kg/m2).

• Subjects with a known history of moderate to severe heart, lung, kidney or liverdisease.

• Subjects diagnosed with moderate to severe asthma.

• Subjects with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia,thalassemia, that in the investigator's opinion, would make them unsuitable forstudy participation.

• Subjects with any other serious systemic illness.

• Any injury, deformity, or abnormality at the sensor sites that, in theinvestigator's opinion, would interfere with the correct functioning of the test orreference devices.

• Subjects with a history of fainting or vasovagal response.

• Subjects with a history of sensitivity or allergy to local anesthetics ordisinfectants if included in the IN study.

• Subjects diagnosed with Raynaud's disease.

• Subjects with unacceptable collateral circulation based on examination by theinvestigator.

• Subjects who are pregnant, lactating or trying to become pregnant.

• Subjects unable or unwilling to provide informed consent or comply with studyprocedures.

• Subjects with any other condition that, in the investigator's opinion, would makethem unsuitable for the study.

• Subjects who refuse to remove nail polish from their index finger.

• Volunteers not willing to remove facial make-up.