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Portable and mobile RF communications can affect the performance of the device.
The device should not be used adjacent, or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
Electrostatic discharge (ESD) may cause artefacts in the signal from the device. Avoid
conditions where electrostatic charge can build up because of low humidity and friction against
carpets, clothing and sheets made from artificial fibres.
The use of accessories, sensors, and cables other than those provided by SOMNOmedics
GmbH may result in increased emission and/or decrease immunity of this device.
This system may be interfered with by other equipment, even if that equipment complies with
CISPR emission requirements.
For patients with pacemakers we recommend placing the SOMNO HD™ on
the abdominal region rather than the thoracic region. We recommend placing
the device at least 7 inches away from the pacemaker. Following these
placement guidelines, there is no indication for complications in patients
with a pacemaker.
Do not use Radio Transmitters and Receivers, High Frequency Devices, CB-
Radio Systems, Cellular Phones, Microwave Ovens, etc. where the electrical
field strength exceeds 3 V/m (in accordance with IEC 60601-1-2)
close to
SOMNO HD™.
Refer to the tables below in this section for specific information regarding the compliance to
the standard IEC60601-1-2.
In accordance with the EMC-regulations for medical products we are obliged by law to provide the following
information.
Guidance and manufacturer’s declaration — electromagnetic emissions
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user
of the equipment should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment
– guidance
RF emissions,
CISPR 11
Group 1
The equipment uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions,
CISPR 11
Class B
The equipment is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions,
IEC 61000-3-2 (*)
not applicable
Voltage fluctuation/flicker
emissions, IEC 61000-3-3 (*)
not applicable
(*) Note: For devices with a power consumption between 75 W and 1000 W only.
Guidance and manufacturer’s declaration — electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user
of the equipment should assure that it is used in such an environment.