Custo Med custo screen 200 Manual De Uso página 39

Manufacturer's Declaration – Electromagnetic Immunity
The custo screen 200 ABPM Recorder is designed for operation in the electromagnetic environment stated
below. The customer or user of custo screen 200 should make sure that it is used in such an environment.
Immunity Tests IEC 60601- Test Level
Conducted HF transients 3 V
eff ective value
according to IEC 61000-4-6 150 KHz to 80 Mhz
Radiated HF transients 3 V/m
according to IEC 61000-4-3 80 MHz to 2,5 GHz
COMMENT 1:
With 80 Hz and 800 MHz the higher frequency range is valid.
COMMENT 2:
These guidelines may not apply in every case. The propagation of electromagnetic variables is infl uenced by
absorptions and refl ections of buildings, objects and people.
a) The fi eld strength of stationary radio transmitters such as e. g. base stations of radio phones and mobile
transmitting stations, amateur radio stations, AM and FM broadcasting as well as television networks cannot
be exactly predetermined theoretically. In order to determine the electromagnetic environment regarding
the stationary transmitters, a study of the location should be considered. If the measured fi eld strength ex-
ceeds the above-mentioned compliance levels at the location where the device is used, the device should
be watched in order to prove the intended functions. If unusual performance features are being observed, it
may be necessary to take additional measures, for example reorienting or relocating the device.
Table 204 according to DIN EN 60601-1-2, 6.8.3.201
Monitorización presión arterial con custo screen 200 y custo diagnostic | GEB 0116 – DK 0897 | Versión 001 – 22.05.2009 | custo med GmbH
Compliance Level Electromagnetic Environment - Guidelines
Portable and mobile radio sets should not be used in
a shorter distance to the device including the leads,
than the recommended protective distance, which is
determined according to the equation of transmitting
frequency.
Recommended protective distance:
d = (3,5/V1) √P
non-applicable
d = 1,2 √P
3 V/m
d = 2,3 √P
with P as nominal power of the transmitter in Watt (W),
according to the indications of the transmitter manu-
facturer and d as recommended protective distance
in meters (m).
According to an examination on-site
strength of stationary radio transmitters should be
inferior to the compliance level, with regard to all fre-
quencies.
In the vicinity of devices carrying the following symbol,
interferences are possible:
80 MHz to 800 MHz
800 MHz to 2,5 GHz
a) the fi eld
39