HiToP
®
191
21
gbo Medizintechnik AG
2005
Version 1.5
Notes in accordance with the EC Directive and
Medical Device Directive
The
HiToP
®
191-H
is a line-powered device for High Tone Power Therapy of safety 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 Notified Body’s number. The corresponding graphical symbol is placed on the type
plate.
According to the Medical Device Directive,
HiToP
®
191
is a device of class
IIa
.
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 corresponds to the
respective current requirements of electrical safety;
•
the device is not used in hazardous environments and humid locations;
•
the mounting, amplifications, readjustments, 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 the Medical Device
Directive.
You may obtain technical support by the manufacturer, dealers or services authorized by the
manufacturer. The product’s life scheduled by the manufacturer is 10 years.
The
HiToP
®
191
is an electronic device. For its disposal the respective regulations for electronic devices
must be observed. Incidentals have to be disposed with residual waste.
On request, the manufacturer will provide 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 of use 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
accessories which are listed in the EC declaration of conformity are used. The use of other accessories
may cause an increased emission of electromagnetic disturbances or may lead to a reduced
electromagnetic immunity.
The unit must not be placed physically close to other devices or stacked on 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.
