gbo Medizintechnik Sonostat, User Manual, Page: 30 / 33

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Sonostat
gbo Medizintechnik AG Version 1.2
12 Appendix
Notes in accordance with EC directive and Medical Device Directive (MDD)
The Sonostat is a line-powered ultrasound-therapy device of the protection class I .
The device is in accordance with the EC directive for medical devices (93/42/EWG) and therefore carries the
CE sign with the registration number of the notified body for medical devices. The according graphical
symbol is placed on the type plate.
According to the MDD,
Sonostat is a class IIa device.
The manufacturer is only responsible for the safety, operational reliability and functionality of the device if:
*
the device is used in accordance with the instructions for use;
* the electrical installation of the location where the device will be used meets the respective current
requirements of electrical safety;
* the device is not used in hazardous environments and humid locations;
* mountings, amplifications, re-adjustments, modifications or repair works are carried out only by
personnel authorized by the manufacturer;
* the operator regulation of this EC directive is observed within the scope of MDD.
Technical support may be obtained by the manufacturer, dealers or service authorized by the manufacturer.
The product’s duration of life as scheduled by the manufacturer is 10 years.
Sonostat is an electronic device. For its disposal the according regulations for electronic devices have to be
observed.
On request, the manufacturer will provide you with further technical descriptions for all repairable parts of
the device, such as circuit diagrams, spare parts lists, and adjustment instructions as far as these are
necessary for the qualified technical staff of the operator.
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 my 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 other devices than current
stimulation units of the brand gbo. 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.