TESI
Relax
29
gbo Medizintechnik AG
Version 2.1
Notes in accordance with the EC Directive and Medical Device
Directive
The
TESI
®
Relax
is a mains operated system for combined physical therapy of protection class
I
.
The device is in accordance with the EC Medical Device Directive (93/42/EEC) and therefore carries the CE
sign with the registration 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
TESI
®
Relax
tables
are devices 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, especially the notes concerning
maintenance and cleaning of the device as described in Chapter 6;
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, 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 framework of the Medical
Device Directive.
You will obtain technical support by the manufacturer, dealers or service authorized by the manufacturer.
The product’s life time anticipated by the manufacturer is 10 years.
The
TESI
®
Relax
tables are electronic devices. For their disposal the respective regulations for electronic
devices have to be observed.
On request, the manufacturer will provide further technical descriptions for all repairable 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 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 using
accessories which are listed in the EC declaration of conformity. The usage 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 close to other devices or stacked. If such an arrangement cannot be avoided the
unit must be observed 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.
