ENVIRONMENTAL SALINE PURIFIERS
There are two models of ambient air salinization devices – a smaller model called Salin S2 and a larger model called Salin Plus. Due to the controlled recrystallization technology used, the saline filters of these devices generate a large amount of salt aerosols with all their very compact format.
TWO NEW PRODUCTS
Over time, the range of devices has been enriched with two new products, which have allowed an even better concentration of the saline effect: the SaltMed medical inhaler and the individual InSalin Inhaler. The technology used is slightly different from environmental devices to ensure a higher and concentrated emission of particles, which is necessary due to the use of that inhaler.
The InSalin Inhaler is an extension of the possibility of using saline air by the user also outside the home or office where it would have saline air produced by environmental devices. There are people among the users with various respiratory problems who need high mobility or who are in periods of maximum allergic crisis.
The SaltMed inhaler is the product with the highest medical efficiency, the therapy being rigorously controlled in terms of the quality and quantity of the emitted particles. This device has been tested in various medical studies both during the home therapy of patients and in intensive care units in postoperative adult patients or in mechanically ventilated premature infants.
The device ensures a controlled emission with a high concentration of saline aerosols with a size of 0.3-5 microns. Salt particles with dimensions between 0.3-5 microns are the only ones able to effectively reach the depth of the respiratory system and determine the therapeutic effect.
The Salin Plus, Salin S2 and InSalin devices are medically CE class 1 certified. In other words, they are certified for the entire EU. Moreover, the SaltMed Inhaler has a CE class II medical certificate from “Bureau Veritas from Italy” certifier – the most severe certification from the devices produced by us and the reason why we used a certifier from Italy is that in Romania we do not have such certification body. In fact, with the same Bureau Veritas Italia, the medical certification ISO 13485 of the production system for our entire product range is also performed.
These certifications are the result of extremely demanding certification procedures, which involve many tests related primarily to the safety of the device, medical evidence of operation, extremely rigorous production, control, traceability throughout the implementation and use flow.
At the 51st edition of the “World Exhibition of Innovation, Research and New Technology” EUREKA, in BRUSSELS
At the 30th edition of the International Exhibition of Inventions, Techniques and New Products in Geneva
ISO 13485 sets out the requirements for a quality management system specific to the medical device sector
ISO 9001 certification symbolizes a confirmation of an organization’s (certified) compliance with the requirements of the ISO 9001: 2008 standard.