FAQs

Answers to some of your most asked questions.

General Questions

 

Where is the X-VENT manufactured?

Every X-VENT is manufactured in the United States at Enexor’s manufacturing facility located in Franklin, Tennessee – a suburb of Nashville.

What and who is Enexor Health Systems?

Enexor Health Systems is a wholly-owned subsidiary of Enexor Energy LLC, and specializes in the development of affordable, easy-to-use medical devices.

What is the X-VENT?

The X-VENT is a continuous use, emergency ventilator intended to provide invasive and noninvasive ventilatory support for adult patients weighing over 35kg, experiencing respiratory insufficiency or failure.  The X-VENT is to be used under prescription only and is intended for use in hospitals, hospital type-facilities, or other institutional health care environments. The X-VENT provides patients with emergency ventilatory support when no alternative, standard ventilators are available.

The X-VENT is intended for use by qualified physicians and respiratory therapists who have undergone training on the use of the X-VENT ventilator. It provides three (3) modes of ventilation: Pressure Control (PC), Volume Control (VC), and Assist (AM).

For more details on the X-VENT’s modes of ventilation and how they function, contact us.

Where are you shipping the X-VENT?

The X-VENT is proudly manufactured in Tennessee and can be shipped anywhere in the world. For more information on shipping to countries outside the United States please contact us.

Is the X-VENT FDA approved?

The X-VENT is approved for use by the FDA under the Emergency Use Authorization (dated March 24, 2020).  It was added to Appendix B of the Emergency Use Authorization Letter on June 10, 2020.

You can view the X-VENT’s authorization status here.

How do I order the X-VENT?

Please reach out to Enexor Health Systems directly at info@enexorhealth.com or +1 (615) 224-8466 to speak with one of our business specialists.

How long does it take to receive orders?

Due to high demand, lead times vary. Enexor Health Systems prioritizes orders based on regional demand.

How much does one X-VENT unit cost?

The X-VENT was engineered to be substantially less expensive than full-feature ventilators. For pricing and shipping cost inquiries, please reach out to Enexor Health Systems directly at info@enexorhealth.com or +1 (615) 224-8466, and one of our specialists will be happy to assist you.

 

 

Clinical Questions

 

What level of control function does the X-VENT have?

What are the alarm settings and are they adjustable?

The X-VENT has built-in alarms to alert the clinician when a patient and/or ventilator issue occurs. When an alarm is activated, an audible sound is emitted and a powerful light on top of the X-VENT flashes. The HMI screen will also flash red when alarms are active. Audible sounds can be silenced for up to 60 seconds to allow the clinician to make settings changes to address whatever condition triggered the alarm. During this time, the HMI will continue to flash. The table below lists all the alarms, their description, whether the user can configure them, and to which modes they apply.

X-VENT Alarms Table

What consumables are required to treat a patient with the X-VENT?

When treating a patient, the following accessories are required:

  • Manual set PEEP
  • Bacterial Filter (expiratory limb only)
  • Dual-limb patient circuit
  • Patient Wye
  • HME

In assist mode, how does the Ventilator detect a spontaneous breath from the patient?

The X-VENT uses a configurable pressure threshold to detect a breath from the patient.

In order for a patient to trigger a spontaneous breath, the breath attempt must meet 4 conditions:

  1. Expiratory time must exceed inspiratory time set point.
  2. Expiratory pressure must be within +0.3/-0.1 cmH2O of PEEP setting.
  3. The difference between measured inspiratory and expiratory tidal volumes must not exceed 20 mL.
  4. Expiratory flow must be less than 6L/min (100 mL/s).

Can the X-VENT be used to treat pediatric patients?

The X-VENT is not currently labeled to treat pediatric patients per the FDA labeling guidelines and regulations.  The ventilator is currently labeled with a minimum inspiratory tidal volume of 200 mL.

Is the X-VENT invasive or noninvasive?

The X-VENT can provide BOTH invasive and noninvasive therapy as determined by a qualified physician or respiratory therapist.

What is the X-VENT’s pressure safety release setting?

The X-VENT’s pressure safety release setting is 50 cmH2O. The clinician can set the max pressure at 40 cmH2O.

What is the X-VENT’s inspiratory tidal volume?

The X-VENT is designed to handle tidal volumes of up to 1,000mL.

Is exhalation with the X-VENT active or passive?

The X-VENT is a passive exhalation system.

Does the X-VENT protect against aerosolizing the viruses during inhalation or exhalation?

The X-VENT is a non-recirculating system where the inspiratory and expiratory lines are separate. For inspiration, room air is filtered through a bracket-mounted HEPA air filter. This filter is changed according to instructions provided in the user manual. The expiratory line uses a patient circuit HEPA filter, located at the bulkhead, which needs to be replaced after each patient.

Is the X-VENT meant to replace full-feature ventilators?

The X-VENT was designed by RTs for RTs. It is an elegantly simple yet highly capable ventilator, that is extremely easy-to-use.

The X-VENT is a continuous use, emergency ventilator intended to provide invasive and noninvasive ventilatory support for adult patients > 35kg of weight with respiratory insufficiency or failure. The X-VENT is to be used under prescription only and is intended to be used in hospitals, hospital type-facilities, or other institutional health care environments. The X-VENT provides patients with emergency ventilatory support when no alternative, standard ventilators are available.

The X-VENT is intended for use by qualified physicians and respiratory therapists who have undergone training on the use of the X-VENT ventilator. It provides three (3) modes of ventilation: Pressure Control (PC), Volume Control (VC), and Assist (AM).