MHW 0010 – DK 1696 | Version 001 – 21/09/2017 | custo med GmbH
2
[2] Cardiac Rehabilitation hardware, custo guard (custo cardio concept) |
page 19
Cardiac Rehabilitation
Hardware, description of device for custo guard (custo cardio concept)
Manufacturer’s declaration – electromagnetic immunity
The custo guard ECG transmitter is designed for use in the electromagnetic environment stated below. The cus-
tomer or user of custo guard should make sure that it is used in such an environment.
COMMENT 1:
With 80 MHz 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 influenced by ab-
sorptions and reflections of buildings, objects and people.
a)
The field strength of stationary transmitters, such as e.g. base stations of mobile phones and land mobile radi-
os, amateur radio stations, AM and FM broadcasting as well as television networks cannot be exactly predeter-
mined theoretically. In order to determine the electromagnetic environment regarding the stationary transmit-
ters, a study of the location should be considered. If the measured field strength exceeds the above-mentioned
compliance levels at the location where custo guard is used, the device should be watched in order to prove the
intended functions. If unusual performance features are observed, it may be necessary to take additional meas-
ures, for example reorienting or relocating custo guard.
b)
Within the frequency range of 150 kHz to 80 MHz, the field strength should be less than 10 V/m.
Immunity tests
Conducted HR disturbances
according to IEC 61000-4-6
Radiated HR disturbances
according to IEC 61000-4-3
IEC 60601 test level
3 V
effective value
150 KHz to 80 Mhz
3 V/m
80 MHz to 2.5 GHz
Compliance level
[U
1
] V
Not applicable
E
1
= 10 V/m
Electromagnetic environment - guidelines
Portable and mobile radio sets should not be used at a
closer distance to custo guard including the leads than
the recommended protective distance which is deter-
mined according to the equation applicable to the fre-
quency of the transmitter.
Recommended protective distance:
d = [3.5/U
1
)] √P
d = [3.5/E
1
] √P
for 80 MHz to 800 MHz
d = [7/E
1
] √P
for 800 MHz to 2.5 GHz
with P as the nominal power of the transmitter in watt
(W) according to the indications of the transmitter man-
ufacturer and d as the recommended protective distance
in meters (m).
According to an examination on-site
a)
the field strength
of stationary radio transmitters should be inferior to the
compliance level
b)
with regard to all frequencies.
In the vicinity of devices carrying the following symbol,
interference is possible:
