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BiOxy Emergency Ventilator

Intro

What is BiOxy?

BiOxy is a purely pneumatic-powered, time and pressure-controlled emergency ventilator.

With display of:

  • inspiratory airway pressure Paw, ranging from 1-80mbar
  • resulting in a tidal volume ranging from 300ml to 4000ml depending on compliance of the patient lungs
  • supply pressure Psupply , 3-6bar minimum of 60l/min
  • Inspiratory time Tin , 0.2 to 30s
  • Expiratory time Tex , 0.2 to 30s
  • BPM as result of the Tin and Tex: 5-35 BPM

The BiOxy relies on external oxygen/air blenders for providing the correct air/oxygen concentration and on external monitoring. BiOxy will provide oxygen concentrations between 21% and 100%, according to the blended air input.

BiOxy
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Intended Use

For use by healtcare professionals

The BiOxy is a purely pneumatic-powered, time and pressure-controlled emergency stationary ventilator for use by healthcare professionals in healthcare facilities.

The BiOxy ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >12 years of age and >20kgs. It is intended to be used in the hospital or other institutional healthcare environments, as well as spaces converted for the care of large numbers of COVID-19 patients (e.g. convention centers, university dormitories, motels). The BiOxy ventilator is intended for use by qualified, trained personnel under the direction of a physician.

Definitions

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Warning

A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

 

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Caution

A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property.

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Note

A NOTE provides additional information intended to avoid inconvenience during operation.



Disclaimers / Warnings

Disclaimers:

The product should only be used during the duration of the COVID-19 Emergency Use Authorization. BiOxy was developed under the guidelines and approved by FDA under Emergency Use Authorization criteria for ventilators.

Warnings:

The product should only be used during the duration of the COVID-19 Emergency Use Authorization. BiOxy was developed under the guidelines and approved by FDA under Emergency Use Authorization criteria for ventilators.

Warning!

Strictly follow these Instructions for use:

  • Any use of the product requires full understanding and strict observation of all portions of these instructions. The device is only to be used for the purpose specified under. "Intended Use" and in conjunction with appropriate patient monitoring. Observe all WARNING and CAUTION statements throughout this manual and all statements on device labels.
  • Standby manual ventilation system; If the life-preserving function of the ventilator is no longer guaranteed due to a fault, the patient must immediately be ventilated with an alternative independent ventilating device, e.g. with a self-filling manual breathing bag.
  • Standby manual ventilation system; If the life-preserving function of the ventilator is no longer guaranteed due to a fault, the patient must immediately be ventilated with an alternative independent ventilating device, e.g. with a self-filling manual breathing bag.
  • Do not use the equipment in conjunction with magnetic resonance imaging (MRI, NMR, NMI). The apparatus may malfunction, causing danger to the patient.
  • Ventilation monitoring during ventilation, the patient must be constantly be monitored by qualified medical personnel.
  • Under no circumstance the ventilator may be operated by any other than the responsible doctor or qualified professional.
  • Ventilator shall only be used indoor and have room-temperature before being used.
  • Ventilator shall, while being used, be placed at a flat and even surface. Make sure the surface is secured from tilting or falling over.
  • Ventilator must not be used in a moist environment (shower, any other washing area, outdoor etc)
  • Ventilator shall not be moved while the patient is connected to it.
  • Ventilator must be stored in a way which prevents unauthorized people from accessing the Ventilator.
  • Ventilator must be stored in a dry room.
  • Ventilator shall be secured properly when transported to avoid transport damage.
  • Never use the product, with or without patient, if the ambient temperature is exceeding the maximal temperature 40°C.
  • A pre-usage check should be performed every time before use with a patient.
  • If the resuscitator entrains or permits the patient to inhale gas from the atmosphere, its use in contaminated environments can be hazardous.
Caution!
  • The ventilator must be set up, used and maintained as described in this manual.
  • No modification of this equipment is allowed. Modifications may lead to dangerous situations and product breakdown.
  • The device is tested on performance with the provided accessories list only.