Emc Hints - gbo Medizintechnik Duodynator Instructions For Use Manual

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15 EMC Hints

Comments According to the Medical Device Directive
The Duodynator is a mains operated current stimulation device of protection class I.
The device is in accordance with the EC Medical Device Directive (93/42/EEC) and therefore carries the
CE-sign with the number of the "notified body for medical devices". The respective graphical symbol is
placed on the type plate.
According to the Medical Device Directive, Duodynator is a device of class IIa.
The manufacturer is only responsible for the security, operational reliability and functionality of the device
if:
* the device is used in accordance with the user manual;
* the electrical installation of the location where the device will be used corresponds to the
respective current requirements of electrical safety;
* the device is not used in hazardous environments and humid locations;
* the mountings, add ons, internal adjustments, modifications or repairs are realized only by
personnel authorized by the manufacturer;
* the operator regulation of this EC-directive is observed within the scope of the Medical Device
Directive.
You may obtain technical support by the manufacturer or the dealers or service authorized by the
manufacturer. The manufacturer projects a product life of 7 years.
Duodynator is an electronic device. Disposal has to be done according to regulations for electronic devices.
Consumables have to be disposed as residual waste.
On request, the manufacturer will provide you with further technical descriptions for all serviceable parts of
the device, such as circuit diagrams, spare part lists and adjustment instructions as far as these are of use for
the qualified technical staff of the user.
Comments on electromagnetic compatibility (EMC)
Medical, electrical devices are subject to special precautions concerning the EMC. They must be installed
and operated according to the EMC-advice given in the accompanying documents. In particular medical,
electrical devices may be influenced by portable and mobile RF-communication devices.
The manufacturer guarantees the conformity of the unit with the EMC-requirements only when using
accessories which are listed in the EC declaration of conformity. The usage of other accessories may cause
an increased emission of electromagnetic disturbances or may lead to a reduced electromagnetic immunity.
The unit must not be arranged physically close to other devices or stacked with them. If such an order is
necessary nevertheless, the unit must be observed in order to check it for the intentional operation.
You find more EMC-comments in the chapter "Warnings and Safety Precautions" of this manual as well as
in the Technical Information on the next two pages.
 gbo Medizintechnik AG
Duodynator
Version 1.2