Manufacturer's EMC Declaration
17
Page 39
The enPuls
Pro
is developed according to the recognized standards of technology; the information on the intended use of the
components is taken into account.
The enPuls
Pro
must not be operated near active HF surgery devices or magnetic resonance imaging that can cause high
levels of electromagnetic interference.
The enPuls
Pro
is exclusively provided and tested for professional health care facilities such as hospitals.
The enPuls
Pro
has no essential performance features that could be influenced 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 enPuls
Pro
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 enPuls
Pro
contains no interchangeable components, cables or other elements that lead 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 enPuls
Pro
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 enPuls
Pro
is developed according to the recognized standards of technology; the information on the intended use of the
components is taken into account.
The device enPuls
Pro
does not contain any components which age over the course of the device lifetime 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 enPuls
Pro
is intended for use in the electromagnetic environment specified below. The customer or user
of the device enPuls
Pro
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 enPuls
Pro
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 enPuls
Pro
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
Summary of Contents for enPulsPro
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