ΑMBU SILICONE FOR ADULTS
Product description
This is used to provide artificial respiration / resuscitation.
Resuscitator is mainly made of silicon / rubber components. The dimensions of vary with the end use
Accessories
The main accessory in case of resuscitator is mouthpiece.
OBJECTIVE
This technical file is established for conformity assessment to enable public authorities to ensure that the product places on the market confirm to the require meets as expressed in the provisions of the directives in particular with regard to the health and safety of users and consumers.
Intended Use of Product - The product is used provide artificial respiration / resuscitation.
QUALITY SYSTEM
To realize the objectives of Quality of the Medical Device a documented Quality System in accordance with ISO 9001:2008 and ISO 13485:2003 Quality System & quality assurance in production has been evolved.
RAW MATERIALS
The basic raw materials of resuscitator are rubber / silicon components for bottle and mouthpieces which are being procured from approved Heuer International subcontractor (s). Each consignment of the raw materials is received with supplier’s test report. Thus these raw materials meet the specified requirements.
RISK ANALYSIS
The products are not sterile; however risk analysis has been carried out [see HI -RA-08] to ensure that,
a) If the risks are addressed properly by adequate labeling during manufacture and packaging then there may hardly be any risk.
b) This risk is eliminated by adoption of ISO 14971:2007 by ensuring appropriate controls.
When quality system management is in place, production and process control system that are in operation ensure that all other risks are not applicable in this product.
c) This analysis also reveals that the laryngoscope is used by a Doctor / Paramedic and in such a case there is no risk at all what so ever.
