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2.8
Oxygen Usage — Warning and Precautions
When using the Vivo 2 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 misconnec-
tion 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 foreseeable 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
monitoring unit which complies with ISO 80601-2-55 and is equipped with a high
oxygen level alarm.
WARNING!
Risk of fire
The presence of oxygen can speed up combustion of inflammable materials.
Risk of Fire
When oxygen is used with the Vivo 2, the oxygen flow must be turned off when the
Vivo 2 is not operating. Oxygen delivered into the patient tubing may accumulate
within the machine enclosure. Oxygen accumulated in the machine enclosure
increases the risk of fire.
Risk of Fire
Ventilate the room adequately. Do not smoke in a room where oxygen is being used.
Risk of Fire
Naked light bulbs and other sources of ignition must be kept a minimum of 2 meters
(6 feet) away from the oxygen cylinder or any part of the patient circuit.
Doc. 007229 D-3
Safety Information
User manual
27
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