Appendix A EMC Information
Guidance and Manufacturer’s Declaration
Warning
Medical Electrical Equipment needs special precautions regarding EMC and needs to
b e i n s t a l l e d a n d p u t i n t o s e r v i c e a c c o r d i n g t o t h e E l e c t r o m a g n e t i c
Compatibility[EMC]information provided
in the accompanying documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment.
The equipment or system should not be used adjacent to or stacked with other
equipment and that
if adjacent or stacked use is necessary,the equipment or system should be observed to
verify normal operation in the configuration in which it will be used.
NOTE
-The EMC tables and other guidelines provide information to the customer or
user that is essential in determining the suitability of the Equipment or System for the
Electromagnetic Environment of use,and in managing the Electromagnetic Environment
of use to permit the Equipment or System to perform its intended use without disturbing
other Equipment and Systems or non-medical electrical equipment.
IMMUNITY
test
IEC 60601 test
level
Compliance
level
Electromagnetic environment –guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHZ
outside ISM
bandsa
3 V/m
80 MHz to 2,5
GHz
3V
3V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the XXXXXXX, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Guidance and manufacturer’s declaration – electromagnetic immunity
This device is intended for use in the electromagnetic environment specified below.
The customer or the user of
should assure that it is used in such an environment.
this device
Respiratory Medical Solutions
19
18
Recommended separation distances between portable and mobile RF communications
equipment and this device.
T
is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of
can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and
as recommended below,
according to the maximum output power of the communications equipment.
his device
this device
this device
Rated maximum
output powerof
transmitter
(
)
W
Separation distance according to frequency of transmitter( )
m
150 kHz to 80 MHZ
80 MHz to 800 MHZ
800 MHz to 2,5 GHz
0.01
0.117
0.117
0.233
0.1
0.36999
0.0.36999
0.73681
1
1.17
1.17
2.33
10
3.69986
3.69986
7.36811
100
11.7
11.7
23.3
