Frequently asked questions about LEITAT 1 ventilator

LEITAT 1 is a device which has been designed to keep in vital support a patient in a situation of severe respiratory failure who requires intubation and invasive mechanical ventilation.

It should not be considered as a partial ventilatory support system (non-invasive mechanical ventilation – NIMV) in patients who ventilate spontaneously, since it does not allow trigger activation. Therefore, it is necessary to consider the profile of each patient when using the ventilator.

It is not a therapy, it is a support intervention, a medical device for ventilatory and temporary support therapy that ventilates the patient while correcting the originating problem.

LEITAT 1 works as volume-controlled ventilation and its mode of operation is mandatory.

In normal operating mode, the user can control the number of ventilatory cycles per minute (respiratory rate), as well as the air volume and the inspiratory time. The inspiratory time setting (in seconds) determines the desired ratio between inspiration time and expiration time (I: E). It is advised that this ratio be as close as possible to 1: 2.

Different studies show that the adjustable PEEP valves during continuous use are unreliable, while the PEEP system by water column is 100% reliable and precise.

No, it should only be filled with distilled water to avoid a potential growth of microorganisms.

The device is equipped with a digital screen and 4 buttons for the selection of alternative set-up screens and / or functions.

In the main screen, the main ventilation parameters can be set up, which are:

  • Tidal Volume
  • Inspiratory time
  • Respiratory rate

The equipment has a special screen for setting or adjusting medical parameters and alarms. The configurable parameters are:

  • Tolerance between the specified air and the delivered air (%). Between 0 and 15%.
  • Correction on total volume when there is a discrepancy between the specified and the delivered volume (%).
  • Maximum pressure (cm H2O). Limit can be reduced to 50 cm H2
  • Alarm error threshold between volumes before warning (%).
  • Tolerance between specified cycle duration and actual duration (%).

The ​​displayed and editable values in this screen should not be modified during the normal operation of the device. A trained technician may modify such values when needed while adjustment, start-up or maintenance operations.

This screen has been mainly designed for those cases in which the resuscitation balloon must be replaced due to damage. In addition, it allows adjusting the ratio between the actuator span and the volume of delivered air.

Yes, the device continuously self-monitors its operation and, in case that any of the actual delivered parameters deviate from the setpoints, the alarm will activate to notify the medical staff.

For supervision, LEITAT 1 is equipped with several sensors. The main ones for the operation of this device are: flow sensors, which monitor and control the delivered volume; and pressure sensors, one digital and one analogue, which monitor the delivered pressure and set a limit to ensure that the established safety values are not surpassed.

The alarm is visual, light and sound. The screen displays the error by text, light indicators light up so that it can be noticed in the distance, and finally, by means of a piezoelectric buzzer, an audible alarm will alert the medical staff.

For example, in the case of detecting a pressure higher than 50 cmH2O, a sound and light warning alarm is activated and, automatically, the operating mode changes from the “Volume Control Mode” to the “Pressure Control Mode”, maintaining the cycle of 1 inspiration per 2 expirations, but applying a volume of air that does not exceed the pressure of 50 cmH2O.

In addition, the equipment is protected against overvoltage and, in the event of a power failure, an alarm will sound to warn that the equipment has stopped due to a lack of voltage.

All alarms are manifested visually and through the piezo buzzer.

No, it has a non-return valve -one way- that delivers air to the patient but does not allow the expired air to return to the resuscitation balloon. It takes it through the expiration tube to the PEEP device. In addition, the instrumental blank space of the tube has a bacterial / viral filter and a humidifier, necessary for this type of patients, which prevents air pollution, both inspired and expired.

No incidence of oxygenation has been detected in the different tests carried out.

No, the device is ready to support patients with COVID19 who have ARDS in severe phase and who cannot be treated with conventional ventilators due to high demand and lack of availability.

No, the system is adjusted before released from the factory. A priori, the user does not have to use it, only in case of problems with the equipment, for example, if the machine starts delivering irregularly the air specified on the screen. In this case, it must be re-adjusted. 

The equipment must be connected to a UPS or a line powered by a UPS to ensure operation in the event of a power failure.

The equipment’s alarm system has a battery which, in the event of a power supply system failure, will ensure the alarm function for at least 20 minutes.

Yes, if the alarm system battery needs to be replaced, it must be replaced by one with identical characteristics. Replacing the battery with one of different characteristics could lead to improper operation of the alarm system.

No, both the flow sensor, the tubing, the PEEP bottle and the valve can be removed and sterilized using the usual procedures of the healthcare center. The housing can be cleaned externally with bleach.

No, the AMBU is provided together with the device, as it has been designed for a specific type of AMBU. Always use accessories, parts and original parts of this equipment.

Modification or replacement by non-original parts may cause this equipment to malfunction. Furthermore, failure to comply with this point could put the safety of the patient and the operator at risk.

Only the filter and the humidifier.

No, the length is fixed. The sensor is located at the point closest to the patient’s mouth. The length of the sensor cable is approximately 1.80 meters, like that of the tube that carries the inspiration air, on which it is supported. It is the maximum distance that can be between the ventilator and the patient.

The equipment has undergone different reliability tests in the laboratory, having been in operation for more than 48 hours in maximum operating conditions (maximum volume, pressure and frequency) as requested by the AEMPS, although some devices have been operating for more than 10 days in a row.

The device has also passed tests on animals for 6 hours and on real patients for 2 hours.

You can request the necessary units through the SEM, which have been assigned for the distribution of LEITAT 1 respirators by CatSalut, and adhere to the clinical study accepting the regulations to be followed and the data collection. This is an open clinical study to which any ICU in Catalonia can join.
Yes, we have a team of volunteer engineers from the Col·legi d’Enginyers de Catalunya who will help us move with a prototype to any health center and carry out the installation and demonstration of the respirator.