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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 SOMNOtouch
™ on the
abdominal region rather than the thoracic region. We recommend placing the
device at least 6 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
SOMNOtouch
™.
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 (*)
Class A
Voltage fluctuation/flicker
emissions, IEC 61000-3-3 (*)
Complies
(*) 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.
Immunity test
IEC 60601- test level
Compliance level
Electromagnetic environment
– guidance
Electrostatic
discharge (ESD),
IEC61000-4-2
2,4,6 kV contact
2,4,8 kV air
2,4,6 kV contact
2,4,8 kV air
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst,
IEC 61000-4-4
2 kV for power supply lines
1 kV for input/output lines
2 kV for power supply lines
1 kV for input/output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge,
IEC 61000-4-5
250V,500V,1 kV
differential mode
2 kV common mode
250V,500V, 1kV
differential mode
2 kV common mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Summary of Contents for SOMNOtouch RESP eco
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