Monitored Therapeutics GoSpiro Spirometer - Safety Warnings and Cautions; General Risk and Damage Alerts; Manual Reading Advisory; Hazardous Environment Warning

Monitored Therapeutics, Inc. © Copyright 2020 6 P/N 45-50035 Rev. K, 2020-10-21
5. WARNINGS AND CAUTIONS
WARNING: Messages that alert you to conditions that could place the patient or
operator at risk.
CAUTION: Messages that alert you to conditions that may result in damage to
equipment.
CAUTION: Read the manual before use
WARNING: The instrument is not suitable for use in the presence of explosive or
flammable gases, flammable anesthetic mixtures or in oxygen rich environments.
WARNING: Medical electrical equipment needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put into service
according to the EMC information provided in the accompanying documents.
Electromagnetic interference can affect the accuracy of the GoSpiro measurements.
WARNING: Portable and mobile radio frequency (RF) communications equipment
can affect the transmission of data from medical electrical equipment. Do not use the
GoSpiro in the presence of external radio equipment.
WARNING: Keep GoSpiro away from strong sources of magnetic and RF fields,
such as large electric motors, amateur radio transmitters, radar, anti-theft systems
(including demagnetizers), stereo speakers, cell phone, and radio frequency
identification (RFID). Note that the presence of RFID may not be obvious. Be
aware that television and radio transmitters could cause interference if the device
is used close to them.
WARNING: The accuracy performance of GoSpiro can be affected by the patient
spitting or coughing into GoSpiro during expiration without use of a filter. Do not use
without the filter provided. Accuracy can also be affected by extremes of temperature,
humidity and altitude. Do not use or store in temperatures that exceed those listed in
these instructions.
WARNING: The accuracy performance of the GoSpiro can be affected if the bottom
of the GoSpiro is exposed to a strong light source while operating the spirometer. Do
not expose to bottom of the GoSpiro to a strong light source.
WARNING: The mouthport filter and/or mouthport adapter must only be used on a
single patient. Replace the filter in accordance with the instructions that come with it.
Use by more than a single patient can cause transmission of infectious material. Be
certain to purchase an adequate supply of filters that matches the number of tests you
were told to perform and the frequency of filter changes.
WARNING: Do not attempt to perform any service or any modifications of this
equipment.