Bemer Therapy System Evo Instrucciones De Uso página 19

Immunity tests ICE-60601 test level
Conducted RF disturbance in 3 V
eff
accordance with IEC 61000-4-6 150kHz to 80MHz inside the ISM/
amateur band
6 V
eff
150kHz to 80MHz inside the ISM/
amateur band
Radiated RF disturbance in 10V/m
accordance with IEC 61000-4-3 80 Mhz to 2.7GHz
Immunity to RF telecommunication equipment pursuant to limit values
of IEC 61000-4-3 tested and passed
Electromagnetic Environment – Guidelines
Recommended protective distance: d = 1.2 √P
d=1.2 √P for 80 MHz to 800 MHz
d=2,3 √P for 800 MHz to 2,5 GHz
With P as rated output of the transmitter in watts (W) pursuant to information from the transmitter
manufacturer and d as the recommended protective distance in meters (m). For all frequencies
pursuant to an examination on sitea, the field strength of stationary radio transmitters is lower
than the compliance leveld. Disturbances can occur in proximity to devices that are marked with
the following symbol:
Remark 1: The higher value applies for 80 MHz and 800 MHz.
Remark 2: These guidelines may not apply in all situations.The radiation of electromagnetic waves is
influenced by absorption and reflections from buildings, objects and people.
(a) Theoretically, the field strength of stationary transmitters such as the base stations of mobile
telephones and mobile terrestrial radio equipment, amateur radio stations, AM and FM radio and
television transmitters cannot be determined in advance. To determine the electromagnetic envi-
ronment with respect to the stationary transmitter, a study of the location should be considered.
If the measured field strength at the location at which the BEMER therapy system is used exceeds
the compliance level indicated above, the BEMER therapy system should be observed in order to
document its intended function. If atypical cable properties are observed, additional measures,
such as a change in alignment or a different location for the BEMER therapy system, may be necessary.
(b) The field strength should be lower than 3 V/m across the 150 kHz to 80 MHz frequency range.
Compliance level
3V
eff
6V
eff
10V/m
80 Mhz to 2.7GHz
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4. BEMER Therapy System Evo
The applicators (B.Pad Evo, B.Body Evo, B.Bed Evo, and B.Sit Evo) and application modules (B.Spot
Evo, B.Light Restore Evo, B.Light Clear Evo) are operated via the controller (B.Box Evo). The applica-
tion modules additionally require the interchangeable adapter (B.Grip Evo).
Power is supplied either via the mains or the rechargeable B.Box Evo Battery Stand (optional
accessory). The medically approved B.Box Evo Car Adapter also allows use of the system via the
on-board power supply of a motor vehicle or boat. Only use the system when the vehicle is
stationary and ensure the B.Box Evo is appropriately secured.
4.1 System description
The BEMER Therapy System Evo is a medical product intended for daily use on humans, which
aims to stimulate microcirculation through the use of pulsed electromagnetic fields (PEMF). It is
also used for treatment of the skin through exposure to light of specific wavelengths (low-level
light therapy or LLLT).
The BEMER Therapy System Evo consists of various applicators (B.Body Evo, B.Bed Evo, B.Pad Evo
and B.Sit Evo) and applicator modules (B.Spot Evo, B.Light Clear Evo und B.Light Restore Evo). The
applicator modules are connected to the B.Box Evo controller together with the holder module
(B.Grip Evo). Without the B.Box Evo controller, neither the individual applicators nor the application
modules can be used.
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