The ‘Andalucía Respira’ ventilator, the only alternative to conventional ventilators with CE marking approved by the Spanish Agency of Medicines and Medical Devices (AEMPS, for its initials in Spanish) in the field of clinical research.
‘ANDALUCÍA-Respira’ MECHANICAL VENTILATION SYSTEM
‘Andalucía-Respira’ is a mechanical ventilation system that is composed of a ventilator, which is easy-to-use and simple in terms of the parameters programmed on its control panel, and an uninterruptible power supply (UPS).
Characteristics of the ‘ANDALUCÍA-Respira’ Ventilator
It is a robust, reliable, compact device with no moving parts that is electronically controlled for Pressure-Controlled Ventilation (PCV).
The machine is indicated for invasive mechanical ventilation as treatment for patients who require mandatory mechanical ventilation with high flow rates for, among others, those with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. The ANDALUCÍA-Respira ventilator model is the only non-commercial ventilator currently approved by the AEMPS (Spanish Agency of Medicines and Medical Devices) as an alternative for this indication.
Through its electronic controls, it allows you to program:
- Respiratory rate (breaths/minute): values between 10 and 40 bpm. (expandable)
- Inspiration/expiration ratio (I:E): 2:1, 1:1, 1:2, and 1:3. (expandable)
- Positive end-expiratory pressure (PEEP): between 5 and 25 cm H2O. (expandable)
Through a manual control, you can control Peak Pressure between 0 – 60 cmH2O.
The inspiratory pause (pressure plateau) time is set at 30%.
- Using a manual command, the Peak Pressure can be controlled between 0 – 60 cmH2O.
- Inspiratory pause time (plateau pressure) is set at 30%.
- To control the percentage of inspired oxygen (Fi O2), a diluent or equivalent system must be available at the oxygen intake of the respirator.
To control the fraction of inspired oxygen (Fi O2), there must be a dilutor or equivalent system in the ventilator’s oxygen intake. It has capacity for:
- Providing more than 1 liter in each inspiration.
- Providing more than 18 liters of oxygen per minute.
Alarms
The ANDALUCÍA-RESPIRA ventilator emits alarm signals in the following cases:
- Pressure error in the patient’s line.
– In the event of low pressure.
– If the pressure reaches very low values or if there is an error in the pressure sensor.
– In the event the pressure limit (40-55 mbar.) is reached.
– In the event of high pressure (> 55 mbar.).
- Plateau pressure alarm < PEEP +5.
- Tidal Volume (TV) Alarm: if Tidal Volume is less than 200 ml. (TV < 200 ml.) or greater than 600 ml. (TV > 600 ml.).
Characteristics of the UPS
The uninterruptible power supply (UPS) safely provides energy to the ventilator. It has autonomy of at least 30 minutes to allow for disconnection of the equipment for transfers within the hospital. Furthermore, the equipment continues functioning in the event of electric power outages, voltage drops, voltage rises, and interference. Furthermore, the UPS emits an alarm signal in the event of electric power outages.
Alarms:
- Battery mode alarm: when the electric power supply is being drawn from the UPS, whether due to disconnection or lack of electric power supply in the facility, it will sound an alarm every 10 seconds/every second when the battery charge level is low.
- Overloading: Beep every 0.5 seconds.
- Battery replacement alarm: Beep every 2 seconds.
- Failure: Beep every 2 seconds.
Note: the equipment may be expanded upon to include new functions and ventilation modes by updating the software.