1. Is RESPIRA an invasive or a non-invasive ventilator?
RESPIRA is an emergency invasive ventilator specially designed to treat COVID-19 patients with severe affections requiring invasive ventilation. It performs the same functionalities as standard invasive ventilators for intensive care units in hospitals.
2. Which types of ventilation does RESPIRA perform?
RESPIRA allows different venitlation modes:
Control Volume: Ventilation mode with target tidal volume adjusting stroke of linear actuator. Itis a non assisted ventilation mode designed for sedated patient treatment. The physician set up tidal volume, frequency and I:E Ratio. (*) This ventilation mode includes the possibility of autoadjustment of minimum and maximum tidal volume and PIP pressure only for the RESPIRA Advanced model.
(*) Assist Volume: This ventilation mode is usable for weaning ventilation,. The patient trigger the frequency. The physician set up tidal volume, Trigger sensibility and apnea time. This ventilation mode includes the possibility of autoadjustment of minimum and maximum tidal volume and PIP pressure.
(*) Assist-Control Volume: Weaning mode: the patient is the trigger of ventilation between frequencies. This ventilation mode includes the possibility of autoadjustment of minimum and maximum tidal volume and PIP pressure.
(*) Ventilation modes only applicable to the model RESPIRA Advanced.
2. Quality and certification
1. Does RESPIRA have CE Mark or FDA certification?
RESPIRA has been recently developed and patented. It has been authorized by the Spanish Health authorities (AEMPS) to be used during COVID-19 emergency situation and it is in process of CE and FDA certification. As certification process depends on an external agency, this process can take few months. Every country is free to join our medical trial and validate RESPIRA accordingly to the local regulations before certification is granted.
2. Does RESPIRA have been tested in clinical trials?
RESPIRA has passed in vitro, animals and human trials with excellent results which guarantee safety and reliability.
3. Does RESPIRA comply the International Standard for Medical devices?
RESPIRA has been tested and approved under the following International standards for Medical Devices:
20/36400724 – ELECTRICAL SAFETY
20/36400721 – EMC
20/32300510 – FUNCTIONALITY FOR RESUSCITATORS
Medical device standards
LCOE, FFII - Spanish Standard for resuscitation bag Automation.
EN 60601-1:2006 + AC:2010 + A1:2013 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
EN ISO 80601-2-12:2011 Medical electrical equipment -Part2-12: particular requirements for basic safety and essential performance of critical care ventilators.
UNE-EN 60601-1-2:2015 (IEC 60601-1-2-2014) Equipos electromédicos. Parte 1-2: Requisitos generales para la Seguridad básica y características de funcionamiento esencial. Norma colateral: perturbaciones electromagnéticas. Requisitos y ensayos. (ratificada por AENOR en noviembre de 2015).
UNE-EN 60601-2-12 (2017) Equipos electromédicos. Parte 2-12: requisitos particulares para la Seguridad de los ventiladores pulmonares. Ventiladores de cuidados críticos (IEC 60601-2-12:2001).
ISO 14971:2012 Medical Devices – Application of risk management to medical devices
ISO 15223-1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements.
UNE-EN 1041:2009 + A1:2014 Information provided by the manufacturer of medical devices.
IEC 62304:2006/A1:2015 Medical device software – Software life cycle processes.
ISO 18562-1:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 1: Evaluation and testing within a risk management process.
ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
4. Does the (STEROS GPA INNOVATIVE, S.L.) manufacturing company comply with ISO13485 quality standards for Medical Devices?
The company has been audited by an external ISO13485 certified Medical Device company supporting the production, quality and development (TECHNOLOGY IN BIOMATERIALS, S.L) and it is compliant with ISO13485 quality standards.
5. Are the components of RESPIRA quality certified?
RESPIRA uses only high quality and certified components from world recognized companies as SIEMENS, SMC, HONEYWELL, ETC)
3. Manufacturing capabilities
1. Which production capacity does RESPIRA have?
The company has a capacity of production of 300 units per day (One shift)
2. Is RESPIRA stock available?
RESPIRA has normally a stock of 200 to 300 units available for delivery but it is subject to current order arrival.
3. Where is RESPIRA manufactured?
RESPIRA is fully manufactured and assembled near Barcelona area, in Spain.
1. What is RESPIRA warranty?
RESPIRA has 12 months of warranty since invoice date.
5. Support capabilities
1. Which services does the company offer?
We offer advanced services all around the world throughout the life cycle of RESPIRA. From technical service, spare parts and advanced online training to on-site consulting, machine set up, operation and maintenance of the Device.
The training we offer is specially designed by the Hospital Clinic and the academic director of clinical simulation laboratory of the faculty of medicine of University of Barcelona.
6. Why RESPIRA
RESPIRA is an emergency ventilator specially designed to heal COVID-19 patients suffering severe pneumonia. It has been developed together with Hospital Clinic and the academic director of clinical simulation laboratory of the Faculty of Medicine of University of Barcelona, Dr. Josep M. Nicolás Arfelis.
The device covers the shortage of ICU ventilators as it can perform the 2 critical phases of pneumonia due to COVID-19. The RESPIRA ventilator performs Control Volume ventilation for patients under clinical sedation, Assist Volume and Assist-Control Volume used to deliver oxygen and support ventilation in patients with hypoxemic, hypercapnic, and mixed respiratory failure. Those ventilation modes are also used to perform a spontaneous breathing trial (SBT) to determine if an intubated patient on control mode ventilation is ready for extubation.
7. How to buy
Which are the steps to use the device in other countries?
1. SIGN THE TERMS SHEET OF THE RESPIRA® DEVICES SALES
This term sheet details the process for commercialization of RESPIRA device in other countries before final certification is granted.
2. ISSUE THE PURCHASE ORDER AND PROCESS THE PAYMENT TO RESERVE YOUR STOCK
Once PO and payment is confirmed the stock of RESPIRA is booked and shipping date is granted.
3. THE DEVICES WILL BE SHIPPED TO DESTINATION
Once all documentation is prepared the products will be ready for shipment and use at destination. Delivery terms are FCA Barcelona.
4. TRAINING, LOCAL HEALTH AUTHORITIES AUTHORIZATION
A complete training program will be organized and the company will help the vendor to submit the documentation to the local health authorities for local authorization.
8. How to pay
100% prepayment by bank transfer
LC is not accepted; due to the present emergency, LC proves not to be a time effective method. In the event of LC been absolutely necessary please contact email@example.com and we will assess a solution.
Order will only be effective upon providing payment proof to be communicated at firstname.lastname@example.org