Smith & Nephew Renasys go Manual De Usuario página 26

Electromagnetic compatibility RENASYS™GO (REF 66801496)
This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2007. These
limits are designed to provide reasonable protection against harmful interference in a typical medical installation and
home use environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular installation.
Guidance and Manufacturer's declaration – electromagnetic immunity.
RENASYS GO is intended for use in the electromagnetic environment specified below. The customer or the user of RENASYS GO
should assure that it is used in such an environment.
Immunity test IEC 60601 test level
±6 kV contact
Electrostatic discharge (ESD)
±8 kV air
IEC 61000-4-2
±2 kV for power supply lines
Electrical fast transient/
burst
±1 kV for input/output lines
IEC 61000-4-4
±1 kV differential mode
Surge
±2 kV common mode
IEC 61000-4-5
Voltage dips, short
<5% U
interruptions and voltage
40% U
variations on power
70% U
supply input lines
<5% U
IEC 61000-4-11
NOTE U is the AC mains voltage prior to application of the test level.
T
Power frequency (50/60 Hz)
3 A/m
magnetic field IEC 61000-4-8
Conducted RF
IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz
Radiated RF 3 V/m 80 MHz to 2.5 GHz
IEC 61000-4-3
NOTE 1: At 80 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which RENASYS GO is used exceeds 3V/m,
RENASYS GO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating RENASYS GO.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
(>95% dip in U ) for 0.5 cycle
T T
(60% dip in U ) for 5 cycles
T T
(30% dip in U ) for 25 cycles
T T
(100% interuption per 5 sec)
T
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Compliance level Electromagnetic environment - guidelines
Floors should be wood, concrete or ceramic
±6 kV contact
tile. If floors are covered with synthetic
±8 kV air
material, the relative humidity should be at
least 30%.
±2 kV for power
Mains power quality should be that of a typical
supply lines
commercial or hospital environment.
Not applicable
±1 kV line to line
Mains power quality should be that of a typical
±2 kV line to earth
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the
>95% for 10ms
user of RENASYS GO requires continued
60% for 100ms
operation during power mains interruptions,
30% for 500ms
it is recommended that RENASYS GO be
>95% for 5000ms
powered from an uninterruptible power supply
or battery.
Power frequency magnetic fields should be at
3 A/m
levels characteristic of a typical location in a
typical commercial or hospital environment.
Portable and mobile RF communications
equipment should be used no closer to any
part of RENASYS GO, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P (80 MHz to 800 MHz)
d = 2.3√P (800 MHz to 2.5 GHz)
3 Vrms
Where P is the maximum output power rating
of the transmitter in watts (W) according to
3 V/m
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a , should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
b