Use Instructions
SpiroSphere
®
ECG Instructions for Use
Page 111/136
Version 02.02 • 04AUG2022
Ambient Conditions
The medical device must not be operated in rooms with the presence of
ammable anaesthetic mixture with air or ammable anaesthetic mixture
with oxygen or nitrous oxide. The medical device must be operated in rooms
where only non-conductive pollution occurs; however, occasional temporary
conductivity due to condensation is to be expected. The medical device is
designed for operation in medically used rooms.
The medical device has to be effectively protected against moisture. Ventilation
slots must be kept free of obstructions in order to enable air circulation.
Putting the Unit into Operation
Temperature changes may give rise to condensation in the device. Consequently,
the device has to adapt to the ambient temperature before putting it into
operation.
Always consult the nameplate on the device/system for compliance of the unit’s
own data with those of the local power supply system (mains voltage and mains
frequency) before actually connecting the unit.
Connect only if all data comply!
Inspect the mains connection cable, plug, and receptacle for visible damages
prior to establishing the connection. Damaged cables or plugs must be replaced
immediately. Installation and assembly of the device must be done only in
compliance with this Instructions for Use.
After the rst setup or if the setup has been changed (e.g. exchanging of the
SpiroSphere Sensor), a function test (e.g. calibration check) has to be performed.
The Main Unit must be placed outside the patient environment during
measurement.
Medical Supervision
During the measurement the patient must not be unattended. A qualied
physician must reassess all measurements. An interpretation by the medical
device is signicant only when considered together with other clinical ndings.
The performance of the spirometer can be affected by the patient spitting or
coughing into the spirometer during expiration or by extremes of temperature,
humidity and altitude.