Accuracy of CardioWatch 287-2 During Profound Hypoxia

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 80601-2-61:2017, Corrected version 2018-02 and ISO 80601-2-55.

SpO2: Testing to confirm the accuracy of the SpO2 monitoring according to ISO 80601-2-61 Clause 201.12.1.101 201.12.1.101

RR Testing: Testing to confirm the accuracy of the respiration rate monitoring according to ISO 80601-2-55. Volunteers respirated spontaneously, no efforts were made to include all ranges of respiration during the study.

PR Testing: Testing to confirm the accuracy of the PR monitoring according to ISO 80601-2-61 Clause 201.12.1.104. No efforts were made to influence PRs of volunteers.

An accelerometer and PPG filters are built in CW2 in order to form the basis to exclude non-eligible test results.

Inclusion criteria

• Healthy non-disabled subjects with American Society of Anesthesiologists health score (ASA) of 1 or 2.
• The subject is aged ≥18 and ≤ 65 years.
• The subject is not intellectual disabled, and has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria

• Heavy smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
• Individuals subject to conditions that result in elevated levels of methemoglobin
• Individuals with hypoxia (SpO2 < 95 % at 21 % of oxygen)
• Severe claustrophobia
• Subject is known with altitude disease
• The subject is obese (BMI ≥ 31 kg/m2).
• The subject has a known history of moderate to severe heart disease, lung disease, kidney or liver disease.
• The subject is diagnosed with moderate to severe asthma.
• The subject is known with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, ... who, in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity or allergy to local anesthetics or disinfectants.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on exam by the investigator.
• The subject is pregnant, lactating or trying to get pregnant.
• The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
• The subject has any other condition, which in the opinion of the investigators would make the subject unsuitable for the study.
• The subject refuses to remove nail-vanish.