Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform

To assess the comparative clinical performance of the Vital Moto Mod device in the
measurement of five vital signs (body temperature, respiratory rate, heart rate, oxygen
saturation and blood pressure) in correlation with a reference device used in the hospital
environment for vital sign measurement.

Vital sign measurement is a core process in delivering healthcare. Body temperature,
respiratory rate, heart rate, oxygen saturation and blood pressure are some of the most
frequently measured vital signs in inpatient as well as outpatient encounters. Currently,
separate devices exist for measurement of each of these vital signs, each of which may have
to be measured several times in a day. Consequently, measurement of vital signs is a time and
human resource intensive process. Moreover, most of the devices currently used to measure
vital signs cannot transmit data to the electronic medical record of patient, thereby
creating opportunities for human error. VVVital USA has used proprietary sensor technology to
develop Vital Moto Mod - a vital sign measurement platform that can non-invasively measure
body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure from a
person's index finger, and allows this information to be pushed into their electronic
medical/health record from the point of care

The primary market focus use of the Vital Moto Mod is to replace the vital sign cart in
hospitals. Vital sign carts are expensive and cumbersome to move around the hospital. At a
fraction of the cost, the Vital Moto Mod provides the same functionality including bar code
scanning at a fraction of the cost. Additionally, the Vital Moto Mod can also be used at home
without the need for a trained nurse. The Vital Moto Mod App will guide a user through the
workflow of performing the measurements. The Vital Moto Mod is connected to a smartphone for
storage, and has a USB interface for charging, thereby requiring no electrical connections
during use. All measurements are taken by the device independent of the phone.

Partners Connected Health will conduct a clinical validation study to evaluate the accuracy
of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate
reference devices used in the hospital setting. The study will recruit volunteers from the
Partners Healthcare network of clinics and hospitals and the general public.

Inclusion Criteria:

For volunteers with one or more vital signs presumed to be within normal physiological
range, at rest:

- Age ≥ 18 years

- Willing to allow arm and finger size to be measured

- Willing to allow measurement of skin color (optional)a

- Willing to undergo exercise testing (optional);

- Willing to allow an arterial blood gas draw (optional);

For volunteers with one or more vital signs expected to be outside of normal physiological
range, at rest:

- Age≥18 years

- Willing to allow arm and finger size to be measured

- Willing to allow measurement of skin color (optional)

Exclusion Criteria:

For Volunteers Undergoing Heart Rate and Oxygen Saturation Measurement:

- Nail paint or artificial nail on the index finger of the left hand

- SpO2 less than 94%

For Volunteers Undergoing Exercise Testing with Vital Signs within Normal Physiological
Range, at rest:

- Volunteers with vital signs outside of normal physiological range (ascertained during
measurements conducted at study site before exercise testing)

- Age 65 years or older

- Consumption of food, alcohol or caffeine (coffee, tea or caffeinated soft-drinks) in a
3-hour period prior to testing

- Uncomfortable clothing, or inappropriate footwear for exercise testing

- Self-report of any of the following:

- History of fall or fracture in the past year

- History of arthritis

- History of dizziness

- History of neurological illness

- History of chest pain or myocardial infarction

- History of hypertension or diabetes mellitus

- History of heart disease

- History of stroke or transient ischemic attack

- Active treatment for anemia, electrolyte imbalance, or hyperthyroidism

- Physical disability that precludes safe and adequate testing

- Mental impairment with limited ability to cooperate4

- Pregnancy (Volunteer will be excluded if either of the following is true: a)
self-report of being pregnant; b) positive urine pregnancy test)

For Volunteers undergoing an Arterial Blood Gas Draw with Vital Signs within Normal
Physiological Range, at rest:

- Self-reported history of a clotting disorder of the blood, or active treatment with
medicines affecting blood clotting (e.g. Warfarin).