Application information
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Prior to using the device on a patient, the user should become familiar with the
instructions for use and individual treatment methods to be used as well as the
indications/contraindications, warnings and application information. Additional
sources of information about the therapy should also be followed.
Please report any serious incidents which occur in connection with the product
to the manufacturer and competent authority.
Caution
!
ThermoTK should not be placed and used in hygienically critical medical areas
such as operating rooms, intensive care units or emergency departments.
Caution
!
Before use, ensure that the device is powered via a properly grounded mains
socket (electrical installation according to DIN VDE 0100 Part 710 or similar).
The device must only be operated with the supplied power cable. The power
cable must be protected against mechanical stress.
Caution
!
Medical electric devices are subject to special precautionary measures with
regard to electromagnetic compatibility (EMC) and must be installed according
to the EMC information in the accompanying documentation. For more
information, see chapter 18 “Manufacturer's EMC declaration”.
Operation of this device in the vicinity of strong electromagnetic fields (e.g.
tomographs, X-ray or diathermy equipment) may interfere with the operation of
the device. Please keep a safe distance of 5 meters.
ThermoTK is not suitable for use in areas with an explosive, flammable or
combustive environment.
During use, the device is to be located in a position allowing direct access to
the device´s central mains supply so that it can be disconnected from the mains
at any time.
To avoid the risk of electric shock, the plug must be disconnected from the
power supply before performing any cleaning or maintenance activities.
Inspect the device and applied parts before use. If there is any damage, it must
not be used.
Caution
!
Only accessories provided by Zimmer MedizinSysteme GmbH which are
intended for this device may be used. This applies in particular to cables and
electrodes. ThermoTK should not be combined with any other medical or non-
medical device.
During the service life of the device, no changes may be made to the device or
medical system.
Do not modify this device without written approval from the manufacturer.
