Oxygen Usage - Warning And Precautions - Breas Vivo 3 User Manual

2.9 Oxygen Usage — Warning and Precautions
When using the Vivo 3 with oxygen, always follow the oxygen provider's instructions and
use only medical grade oxygen complying with local regulations.
WARNING!
As this medical device uses an alternative small-bore connector design different from
those specified in the ISO80369 series, there is a possibility that a misconnection can
occur between this medical device and a medical device using a different alternative
small-bore connector, which can result in a hazardous situation causing harm to the
patient. Special measures need to be taken by the user to mitigate these reasonable fore-
seeable risks.
Do not use a humidifier between the oxygen source and the ventilator, in order to
humidify the oxygen flow.
If humidification is required, use the attachable humidifier or an external humidifier after
the patient air outlet.
Risk of faulty Treatment
At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will
vary, depending on the pressure or flow delivered, the patient interface and leak rate.
To monitor the oxygen concentration, use an external patient air oxygen saturation mon-
itoring unit which complies with ISO 80601-2-55 and is equipped with a high oxygen
level alarm.
Risk of faulty Treatment
The responsible organization shall ensure that the oxygen source is compatible with the
rated range of pressure, flowrate and oxygen concentration for this device.
Failure to use a compatible oxygen source may result in serious deterioration of health.
Doc. 007231 F-3
Safety Information 19
User Manual