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 by PHYSIO-ASSIST under an
ISO 13485:2016 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 specif ications
10
L
W
H
41
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