Electromagnetic Compatibility - smith&nephew VERSAJET II Manual De Instrucciones

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Electromagnetic compatibility

This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2-2006.
These limits are designed to provide reasonable protection against harmful interference 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 VERSAJET II Hydrosurgery System (66800039) is intended for use in the electromagnetic environment specified below. The customer or the
user of the VERSAJET II Hydrosurgery System should assure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
NOTE U is the AC mains voltage prior to application of the test level.
T
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
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
VERSAJET II Hydrosurgery System is used exceeds 3V/m, the VERSAJET II Hydrosurgery System should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VERSAJET II Hydrosurgery
System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
IEC 60601 test level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
<5% U
T
(>95% dip in U ) for 0.5 cycle
T
40% U
T
(60% dip in U ) for 5 cycles
T
70% U
T
(30% dip in U ) for 25 cycles
T
<5% U
T
(>95% dip in U ) for 5 sec
T
3 A/m
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance level
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line to line
±2 kV line to earth
>95% for 10ms
60% for 100ms
30% for 500ms
>95% for 5000ms
0,3 A/m
3 Vrms
3 V/m
18 18 18
Electromagnetic environment - guidance
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 VERSAJET II Hydrosurgery System
requires continued operation during power
mains interruptions, it is recommended that the
VERSAJET II Hydrosurgery System be powered
from an uninterruptible 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 the VERSAJET II Hydrosurgery System,
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 metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
,
a