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Like the Oxylator® EM-100, the Oxylator®
FR-300 is an oxygen-powered (21CFR 868.5925; Product
Code: BTL), patient responsive resuscitator and is intended
to provide emergency ventilatory support for individuals weighing
more than 10 kg (22 pounds).
The Oxylator® FR-300 is primarily designed for use with
a mask by the first responder. Professionals may elect to use
an endotracheal tube at their discretion.
The Oxylator® FR-300 limits the maximum airway pressure
to 20 cmH2O and maintains a low constant flow rate
of 30 liters per minute. These parameters were selected to address
current emergency ventilation consensus and requests by the
EMS community for a low-pressure-low flow device for the unprotected
airway for use by first responders to eliminate the risk of
barotrauma and gastric insufflation in EMS situations.
The Oxylator® FR-300 shares many functional characteristics
with the Oxylator® EM-100. It is simple, safe and effective
and enables the well-trained first responder to concentrate
on properly managing the unprotected airway in an emergency
situation.
The Food and Drug Administration (FDA) classifies the FR-300
in Class II (two) under the Product Code 73 BTL. The device
meets the performance standards as set out in ASTM F920-85 and
ISO 8382. The FR-300 is a Class I (one) device as referenced
in the The Journal of the American Medical Association
(JAMA) 'Guidelines for Cardiopulmonary Resuscitation
and Emergency Cardiac Care', American Heart Association (AHA).
For patents, approvals, and clearances, click
here. |
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