18
HiToP
®
Metabol
gbo Medizintechnik AG
Version 1.4
6
Maintenance
Efficiency, reliability and safety characteristics of the device for High Tone
Therapy are only guaranteed in case of proper use in accordance with the operating
instructions. Safety control, maintenance work, repair work and modifications shall
be carried out only by the manufacturer or the service agents authorized by him. In
case of a failure, parts which influence the safety of the device shall be only
replaced by original spare parts of the manufacturer. The electric installation shall
be carried out in accordance with the requirements of VDE/IEC.
The device does
not contain any parts which need maintenance work done by the user.
6.1 Safety controls
The device is subject to the provisions of the Medical Device Directive. The safety
controls have to be carried out on the basis of this directive. Here, the operator
regulation has to be especially observed.
Irrespective of the legal rules or beyond the scope of the Medical Device Directive,
it is recommended to have the device checked at 12-months intervals by the
manufacturer or by a service agency authorized by him.
The check shall consist of at least the following:
Electrical safety check in accordance with the check plan of the
manufacturer;
Check of the device in regard to external integrity;
Check of all display and operating elements in regard to damage;
Check of all inscriptions in regard to legibility.
6.2 Cleaning, disinfection and care
6.2.1 Cleaning the device
For cleaning and disinfection of the device for High Tone Therapy and its
accessories there shall not be used any agents containing higher portions of phenol
derivates, alcohol, compounds of chlorine or peracetic acid. It is recommended to
use disinfectants on aldehyde basis.
The device is suited neither for heat sterilization nor sterilization with gases.
