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 the 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.
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member State
in which the user and/or patient is based.
Caution
!
enShock 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 earthed mains
socket (electrical installation according to DIN VDE 0100 Part 710 or similar).
The device must only be operated using 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 17 “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 its operation.
Please keep a safe distance of 5 metres.
enShock 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 that allows 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, the
device must not be used.
Caution
!
Only accessories provided by Zimmer MedizinSysteme GmbH that are
intended for this device may be used. The enShock 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.