Safety and maintenance
13.1 Safety
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enShock is manufactured and tested according to currently valid standards for
medical devices.
Zimmer MedizinSysteme GmbH can only consider itself to be responsible for
safety and reliability if:
the device is operated using a proper power outlet with an earth contact and
the electrical installation complies with DIN VDE 0100 part 710 or a
comparable standard;
the equipment is operated in accordance with the instructions for use;
extensions, readjustments or modifications are carried out only by persons
authorised by Zimmer MedizinSysteme GmbH;
the user has ascertained functional safety, a proper operating condition and
mechanical integrity before using the device and accessories;
the device is operated only by medical professionals;
the device is not operated in hazardous areas and/or a combustive
atmosphere; and
the device is immediately disconnected from the mains when penetrated by
liquid.
The device does not contain any parts that can be repaired by the operator.
Fuses and other spare parts may only be replaced by trained service staff.
The device may only be serviced by trained staff. All information required for
servicing can be found in the enShock service manual or can be requested
from the manufacturer. Upon request, Zimmer MedizinSysteme will provide
wiring diagrams, lists of components, descriptions, calibration instructions or
other documents.