MicroPro 45
© gbo Medizintechnik AG Version 1.4
14 Appendix
Comments according to the Medical Device Directive
The MicroPro is a mains operated microwave therapy device of 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.
The MicroPro is class IIa device according to the MDD.
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 potentially explosive 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 manufac-
turer. The product’s duration of life as scheduled by the manufacturer is 7 years.
MicroPro 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 ac-companying 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 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.
In accordance with the EMC-regulations for medical products we are obliged by law to provide the fol-
lowing information.
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