Monitored Therapeutics GoSpiro Spirometer - Contraindications and Environment; Contraindication Advisory; Hemoptysis Contraindication; Pneumothorax Contraindication

Monitored Therapeutics, Inc. © Copyright 2020 8 P/N 45-50035 Rev. K, 2020-10-21
CAUTION: ATS/ERS recommendations indicate that all spirometers used in
laboratories be calibrated or have the calibration verified daily.
6. CONTRAINDICATIONS
WARNING: Do not use the GoSpiro if you have any of the following unless your
physician has cleared you to perform forced exhaled lung function measurements.
Failure to obtain approval from your physician if you have any of these could
result in serious injury or death:
6.1. Hemoptysis (coughing up blood) of unknown origin
6.2. Presence of a pneumothorax (collapsed lung)
6.3. Presence of unstable cardiovascular status:
6.3.1. Recent (within one month) myocardial infarction (heart attack)
6.3.2. Uncontrolled hypertension (high blood pressure)
6.3.3. Pulmonary embolism (blood clot in your lungs)
6.3.4. History of a hemorrhagic cerebrovascular event (stroke)
6.3.5. Unstable angina (chest pain)
6.4. Recent thoracic (chest), abdominal or eye surgery (2 weeks)
6.5. Nausea, vomiting or abdominal pain
6.6. Thoracic or abdominal aneurysms (weak blood vessels in your chest or
abdomen)
6.7. History of syncope (fainting) associated with forced exhalation
6.8. Active tuberculosis or Hepatitis B
7. ENVIRONMENT
7.1. Operating Environment
7.1.1. GoSpiro is designed for use in physician’s offices, clinics and in home
settings .
7.1.2. Use in temperatures outside the range of 17°C to 35°C (63°F to 95°F), should
be avoided.
7.1.3. GoSpiro is designed to operate at altitudes from sea level up to 2588 meters
(8491 feet). Use in altitudes outside the range should be avoided.
7.1.4. GoSpiro is intended to be used indoors only. Use in humid environments
outside the range of 30%RH to 75%RH, non-condensing, and ambient
pressure outside the range of 700hPa to 1060hPa, should be avoided.
7.1.5. The environment must be free of excessive vibrations, and sources of
electrical noise.
7.2. Transport/Storage Environment
7.2.1. The GoSpiro must only be transported or stored in the temperature range of
-20°C to 70°C (4°F to 158°F).