gbo Medizintechnik ULTRATHERM 1008 Instructions For Use Manual page 42

42
Notes in accordance with the Medical Device Directive (MDD)
The ULTRATHERM 1008 is a line-powered short-wave 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.
According to the MDD, confotherm is a class IIb device.
The manufacturer is only responsible for the safety, operational reliability and func-
tionality 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 device is not used in hazardous environments and humid locations;
 mountings, amplifications, re-adjustments, modifications or repair works are
 the operator regulation of this EC directive is observed within the scope of
Technical support may be obtained by the manufacturer, dealers or service author-
ized by the manufacturer. The product's duration of life as scheduled by the manu-
facturer is 10 years.
ULTRATHERM 1008 is an electronic device. For its disposal the according regula-
tions 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 ad-
justment 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.
© gbo Medizintechnik AG
the respective current requirements of electrical safety;
carried out only by personnel authorized by the manufacturer;
MDD.
ULTRATHERM 1008
Version 1.7