Zimmer Z Wave Q, User Manual

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Manufacturer´s EMC declaration
16
Page 26
The
ZWave
Q
is developed according to the recognized standards of technology; the information on the intended use of the
components is taken into account.
The
ZWave
Q
must not be operated near active HF surgery devices or magnetic resonance tomography that can cause high
levels of electromagnetic interference.
The
ZWave
Q is designed for proper use by any professional provider that is legally authorized to use a FDA Class 1 device.
The
ZWave
Q
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
ZWave
Q 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
ZWave
Q 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
ZWave
Q
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
ZWave
Q is developed according to the recognized standards of technology; the information on the intended use of the
components is taken into account.
The device
ZWave
Q 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.
Table 1
Guidance and Manufacturing Declaration- Electromagnetic Emissions
The device
ZWave
Q is intended for use in the electromagnetic environment specified below. The customer or user of
the device
ZWave
Q should ensure that it is used in such environment.
Emission Measurement Compliance Electromagnetic Environment-Guidelines
RF Emissions in accordance
with CISPR 11
Group 1 The device ZWave
Q
must emit electromagnetic
energy in order to ensure its intended function. Nearby
electronic equipment may be affected.
RF Emissions in accordance with
CISPR 11
Class
A The device Z Wave
Q
is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public supply
network that also supplies buildings used for domestic
purpose.
Emissions of Harmonics in
accordance with IEC 61000-3-2
Class
A
Emissions of voltage fluctuations/
flickers in accordance with IEC
61000-3-3
Compliant