Справочник Пользователя для myon AG M320-1
10.1.3 Declaration of Conformity
Declaration of conformity
myon AG, Sonnenrain 75, 6103 Schwarzenberg, Switzerland declares under our sole responsibility
that the devices, listed hereafter;
that the devices, listed hereafter;
•
myon m320 system consisting of
◦ myon m320 transmitters (Model m320TXA, Type PT0001)
◦ myon m320 receiver (Model m320RX, Type PR0006)
◦ myon m320 charging cradle (Model m320CC, Type PA0001)
are in conformity with
•
the Council Directive 93/42/EEC for medical devices (MDD), and
•
the essential requirements and other relevant requirements of Council Directive 1999/5/EC
on radio equipment and telecommunications terminal equipment and the mutual
recognition of their conformity (R&TTE).
on radio equipment and telecommunications terminal equipment and the mutual
recognition of their conformity (R&TTE).
3rd January 2013
Schwarzenberg, Switzerland
Dr. Lars Meinecke
Director of Regulatory Compliance
Not for use in an operating theatre, anesthetic gas or oxygen-rich environments. Not for use where
there is a risk of compromising the essential performance of medical electrical equipment. Not
suitable for use in high magnetic flux, ionizing radiation, sterile, or life- or safety-critical
environments. The device is not suitable for unattended continuous operation. This declaration does
not apply to custom made systems. Further details regarding the declaration of conformity is
available upon request from myon AG, Switzerland.
there is a risk of compromising the essential performance of medical electrical equipment. Not
suitable for use in high magnetic flux, ionizing radiation, sterile, or life- or safety-critical
environments. The device is not suitable for unattended continuous operation. This declaration does
not apply to custom made systems. Further details regarding the declaration of conformity is
available upon request from myon AG, Switzerland.
10.1.4 Medical Device Adverse Event Reporting
Should an adverse incident occur, the appropriate form is to be completed and forwarded within one
working day to myon AG at the following address:
working day to myon AG at the following address:
myon AG
Sonnenrain 75
6103 Schwarzenberg
Switzerland
Sonnenrain 75
6103 Schwarzenberg
Switzerland
email: info@myon.ch
Date: 03.06.2013
LaInMa-EU-m320 - Instructions manual (full version, english) - 20130603 - V1.7.odt
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