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Respiro
7 (48)
Operating Instructions
© Bittium Biosignals 2022
•
Respiro device should not be used adjacent to or stacked with other electri-
cal equipment. If adjacent or stacked use is necessary, the device should be
observed carefully to verify normal operation.
•
Body and hand creams as well as sunscreens can damage the device.
•
Skin must be intact, clean, and dry in the area where the ECG electrode is at-
tached (applicable only in ECG use case).
•
Body-worn parts (eg. medical tape) may irritate skin, but there are no other
known adverse events due to using the Respiro device. If the patient has lots
of body hair it must be shaved from the area where the ECG electrode is at-
tached (applicable only in ECG use case).
•
Any serious incident that has occurred in relation to the device must be re-
ported to the manufacturer and the competent authority of the country in
which the user and/or patient is established.
See also pulse oximeter’s operator’s manual: Operator’s Manual Model 3150
WristOx
2
® Pulse Oximeter BLE and USB:
https://www.nonin.com/support/3150-
Operator’s Manual can also be found from device’s memory.
1.3
Adverse events
Body-worn parts (eg. medical tape) may irritate skin, but there are no other
known adverse events due to using the Respiro device.
1.4
Indications
•
Suspected sleep-related breathing disorder (obstructive sleep apnea, central
sleep apnea, mixed sleep apnea, Cheyne-Stokes respiration)
Table below lists the biosignals and sensors used in Bittium Respiro:
Signal
Sensor
Airflow
Nasal air pressure sen-
sor
Respiratory effort (abdominal) Respiratory inductance plethys-