Zimmer Z Lipo Med, Instructions For Use Manual, Page: 38 / 43

Manufacturer's EMC declaration
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Page 30
The Z Lipo Med was developed according to the recognised rules of engineering; the information on use as
intended of the components was taken into account.
The Z Lipo Med should not be operated near active HF surgical devices or magnetic resonance imaging
devices which can cause significant electromagnetic interference.
The Z Lipo Med is exclusively intended and has been tested for professional healthcare facilities, such as
hospitals.
The Z Lipo Med does not have any key performance features which could be impaired through
electromagnetic interference.
WARNING :
The use of this device next to or stacked with other devices should be avoided since this
could lead to faulty operation. If such use is necessary, the device as well as the other devices should
be continuously observed to ensure that they are working normally.
The electromagnetic compatibility of the Z Lipo Med device was tested on the original device with the
handpiece.
WARNING:
The use of accessories, converters and cables which are not specified or provided by the
manufacturer of this device can lead to increased electromagnetic interference emissions or decreased
electromagnetic immunity of this device, resulting in improper operation.
The Z Lipo Med device does not contain any exchangeable components, cables or other parts which lead
to worsening of the EMC.
WARNING:
Portable HF communication devices (including peripheral devices such as antennas)
should be used at a distance of at least 30 cm (12 inches) from any part of the Z Lipo Med device; this
includes cables indicated by the manufacturer. There may otherwise be a loss of performance of this
device.
The device was tested for HF immunity with selected frequencies only. Transients with other frequencies
occurring in the vicinity can lead to malfunctions. The tested frequencies are listed in Table 4.
The Z Lipo Med device does not contain any components that can age in the course of the device's service
life and lead to a deterioration in electromagnetic compatibility. Thus, no maintenance is required to
ensure basic safety during the life of the device. All tests according to the standard IEC 60601-1-2 Ed.
4.0 were carried out.
Further standards and regulations on electromagnetic compatibility were
not applied.