Appendix - gbo Medizintechnik HiToP 4 touch Instructions For Use Manual

12 Appendix

Comments according to the Medical Device Directive

HiToP 4 touch
The
The device is in accordance with the EC Medical Device Directive (93/42/EEC) and therefore carries the CE-sign
with the number of the "notified body for medical devices". The respective graphical symbol is placed on the type
plate.
According to the Medical Device Directive,
The manufacturer is responsible for the security, operational reliability and functionality of the device under the
following conditions only:
 the device is used in accordance with the user manual;
 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 mountings, add-ons, internal adjustments, modifications or repairs are realized 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 or the dealers or service authorized by the manufacturer.
The manufacturer projects a product life of 10 years.

HiToP 4 touch
is an electronic device. Waste disposal is to be done according to the regulations for
electronic devices. Consumables have to be disposed as residual waste.
On request, the manufacturer will provide you with further technical descriptions for all serviceable parts of the
device, such as circuit diagrams, spare part lists and adjustment instructions as far as these are of use for the
qualified technical staff of the user.
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 if 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 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 the
Technical Information on the next two pages.
 gbo Medizintechnik AG
is a mains operated current stimulation device of protection class I.
HiToP

4 touch
is a device of class IIa.
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