Zimmer Cryo 7, Инструкция по эксплуатации, Страница: 40 / 45

Manufacturer’s EMC declaration
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Cryo 7 was developed according to the state of the art. The information on use as intended of
the components was taken into account.
Cryo 7 should not be operated near active HF surgical devices or magnetic resonance
imaging devices which can cause a high degree of electromagnetic interference.
Cryo 7 is exclusively intended and has been tested for professional healthcare facilities, such
as hospitals.
The electromagnetic compatibility of Cryo 7 device was tested on the original device with the
treatment tube.
Cryo 7 does not have any key performance features which could be impaired through
electromagnetic interference.
WARNING: The use of this device next to or also 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.
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.
Cryo 7 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 not be used at a distance of less than 30 cm (12 inches) from any part of
Cryo 7, including the 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.
Cryo 7 does not contain any components which can age during the life of the device and which can lead
to worsening of the electromagnetic compatibility.
Thus no maintenance is necessary during the service life of the device to ensure basic safety.
All tests according to standard IEC 60601-1-2 Ed. 4.0 were performed. No other standards and
regulations on electromagnetic compatibility were used.