39
10.1 Compliance with standards and regulations
SIMEOX is a class IIa medical device that complies with the requirements of Directive 93/42/EEC on medical devices.
As such it complies with the following standards:
EN 14971 on risk analysis for medical devices
EN 60601-1 on the safety of medical electrical devices
EN 60601-1-2 on the Electromagnetic Compatibility of medical electrical devices
EN 60601-1-6 on the usability of medical electrical devices
EN 60601-1-11 on the use of medical electrical devices in the home
EN 62304 on medical device software
IEC 62366-1 on the usability engineering to Medical Devices
EN 10993-1 on the biocompatibility of materials in contact with the user
SIMEOX is manufactured under an ISO 13485 certified quality system. SIMEOX also complies with the RoHS Directive 2011/65/EU on the restriction of the use of certain dangerous substances, with the REACH regulation 1970/2006 on the registration and evaluation of chemical substances, and with the RED Directive 2014/53/EU on radio equipment. EC certificates of conformity and EC declarations of conformity to European Directives are available upon request.
10.2 Weight and dimensions
L = 280 mm / 11 W = 212 mm / 8 1/3 H = 175 mm / 7 Weight: 5.1 kg / 11 lbs
10.3 Materials used that may come into contact with the patient
Within the meaning of the required standards, all parts of SIMEOX are called applied as they are liable to make contact with the patient. SIMEOX casing: polyurethane acrylic paint. SIMEOX control pad: Autotex Softouch® Remote control casing: PC/ABS (polycarbonate and acrylonitrile-butadiene-styrene) Expiratory kit mouthpiece: Phthalate-free, latex-free, rubber- free biocompatible polypropylene. Expiratory kit filter: 3 mm thick membrane
made of polypropylene fibres retaining up to 99.99% of bacteria and viruses. The filter does not contain latex or bisphenol.
Expiratory kit tube: Phthalate-free, latex-free, Bisphenol A-free PVC
10.4 Operating life The operating life of SIMEOX, if it is used and maintained in compliance with the recommendations in this manual, is five years.
Technical specifications10
