Zimmer MFG-03, Instructions For Use Manual

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Manufacturer's Declaration on
Electromagnetic Compatibility (EMC)
15
Page 26
The MFG-03 is developed according to the recognized standards of technology; the information on the
intended use of the components is taken into account.
The MFG-03 must not be operated near active HF surgery devices or magnetic resonance tomography that
can cause high levels of electromagnetic interference.
The MFG-03 is exclusively for professional health care facilities such as hospitals provided and tested.
The MFG-03 has no essential performance features that could be caused by electromagnetic interference.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.
The electromagnetic compatibility of the MFG-03 device has been tested on the original device with
handpiece
WARNING: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emission or decreased
electromagnetic immunity of this equipment and result in improper operation.
The device MFG-03 contains no interchangeable components, cables or other that leads to a deterioration of
the EMC.
WARNING: Portable RF communication equipment (including peripherals such as antennas) should be used
no closer than 30 cm (12 inches) to any part of the device MFG-03 including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.
The device was tested for RF immunity only at selected frequencies. Nearby transients at other frequencies
may result in degraded operation. The frequencies tested are listed in Table 4.
The MFG-03 is developed according to the recognized standards of technology; the information on the
intended use of the components is taken into account.
The device MFG-03 does not contain any components which age over the course of the device life time and
could lead to a deterioration of the electromagnetic compatibility. Thus, no maintenance is required during
the 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 for electromagnetic compatibility have been applied.