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externally powered, Class II, Type BF device
provide oxygen at a volume that remains within tolerance
may be used continuously in a home or institutional/hospital setting
|Packaging detail:Standard export package
Delivery detail:within 7-10 workdays after receipt of payment
The MSLJY11 stationary oxygen concentrator is an externally powered, Class II, Type BF device. The essential function of the device is to provide oxygen at a volume that remains within tolerance-the tolerance was defined based on technical judgment from within the manufacturer’s expertise in this specific medical application.
In addition, the device’s ability to detect certain error conditions such as low oxygen concentration and create an alarm is also considered a part of its essential function.
INTENDED USE OF THE DEVICE
The MSLJY11 Oxygen Concentrator is used on a prescriptive basis patients who are diagnosed as requiring supplemental oxygen.The oxygen concentrator will provide supplement,high oxygen concentration oxygen to these patients.
It is not life-supporting or life-sustaining.It may be used continuously in a home or institutional/hospital setting.