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ULTRATHERM 908i
gbo Medizintechnik AG 2004
Version 1.6
Prior to the application, the therapy unit has to be checked by the user for convincing that its
function and condition are correct. This includes regular inspections of all cables and lines for
possible insulation defects.
The
ULTRATHERM 908i
complies to the Medical Devices Directive (MDD) 93/42/EEC and
therefore carries the CE sign with the number of the notified body for medical devices.
ATTENTION:
According to its designation the therapy unit generates high frequency electric
and magnetic fields that penetrate even walls, ceilings and floors. It cannot be
excluded that components of these fields exists in the vicinity of the therapy unit.
Sensitive electronic instruments which are arranged in the immediate vicinity of
the
ULTRATHERM 908i
can be disturbed. This danger largely depends on the
distance between the devices. Therefore, during the installation of the therapy
unit, it should be taken into consideration that the distance to other sensitive
devices should exceed 5 m, if possible, and the applicators are not directed to
sensitive devices, as for instance current stimulators.
This problem can be completely eliminated when the therapy unit is accommodated in a shielded
room, that means in a Faraday cage. (A Faraday cage enclosed by a metal housing or grid
prevents the penetration of electric fields.) Often, a sufficient interference suppression is obtained
by only connecting the devices to isolated mains circuits or using screening curtains (special
curtains between the treatment cabins). Supplier is:
nsp- Sicherheitsprodukte GmbH
Hauptstr. 17
86695 Nordendorf
Germany
Phone: 049-8273-1031.
To stay within the limits given by DIN 0848, Part 2, we recommend that the operators and other
persons keep a distance of at least 2 meters to the applicators and cables. In case of doubt, it is
recommended to measure the field strength. Pregnant women should not operate the therapy unit.
ATTENTION:
The therapy unit is not designed to be operated in environments in which there is
danger of explosion. If used in anaesthesia rooms where inflammable narcotics
are simultaneously used an explosion can not be ruled out!
