Electromagnetic Compatibility - smith&nephew RENASYS GO 66801244 Manual De Instrucciones

Electromagnetic compatibility RENASYS™ GO (REF 66801244)
This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2007. These limits and
test levels are intended to provide reasonable safety with regard to electromagnetic disturbances when the device is used in a
typical medical installation. 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
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should
assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic ±6 kV contact
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 <5% U
T
dips, short (>95% dip in U
interruptions 40% U
T
and voltage (60% dip in U
variations on 70% U
T
power supply (30% dip in U
input lines <5% U
T
IEC 61000-4-11 (100% interruption per 5 sec)
NOTE U is the a.c. mains voltage prior to application of the test level
T
Power frequency 3 A/m
(50/60Hz)
magnetic field
IEC 61000-4-8
Conducted RF 3 Vrms 150 kHz to 80 MHz
IEC 61000-4-6
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 the device is used exceeds 3V/m, the
device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Compliance level
±6 kV contact
±8 kV air
±2 kV for power supply
lines
Not applicable
±1 kV line to line
±2 kV line to earth
>95% for 10ms
) for 0.5 cycle
T
) for 5 cycles 60% for 100ms
T
) for 25 cycles 30% for 500ms
T
>95% for 5000ms
3 A/m
3 Vrms
3 V/m
Electromagnetic environment
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%
Mains power quality should be that of a
typical commercial or hospital environment
Mains power quality should be that of a
typical commercial or hospital environment
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the device requires continued
operation during power mains interruptions,
it is recommended that the device be
powered from an uninterruptable power
supply or battery
Power frequency magnetic fields should
be at 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 device, 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)
where P is the maximum output power rating
of the transmitter in watts (W) according
to 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,
than the compliance level in each frequency
range . Interference may occur in
b
the vicinity of equipment marked
with the following symbol:
33
EN
–
guidelines
should be less
a