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GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
The Model P8400 Hemostatix Thermal Scalpel System is intended for use in the
electromagnetic environment specified below. The customer or the user of the
Model P8400 Hemostatix Thermal Scalpel System should assure that it is used in
such an environment.
Immunity Test
Test Level
Compliance Level
Electromagnetic Envi-
ronmental Guidance
Electrostatic
Discharge
IEC 61000-4-2
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wood,
concrete or ceramic
tile. If floors are cov-
ered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
± 2 kV for mains
± 1 kV for signal leads
± 2 kV for mains
± 1 kV for signal leads
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV common mode,
AC mains
± 2 kV differential
mode, AC mains
± 1 kV common mode,
AC mains
± 2 kV
differential
mode, AC mains
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power Frequency
Magnetic Field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields above
those typically found
in commercial or
hospital environments
are acceptable.
Voltage dips, short
interruptions and volt-
age variations on AC
mains
IEC 61000-4-11
> 5% of nominal volt-
age for ½ cycle
40% of nominal volt-
age for 5 cycles
70% of nominal volt-
age for 25 cycles
> 95% of nominal
voltage for 5 seconds
> 5% of nominal volt-
age for ½ cycle
40% of nominal volt-
age for 5 cycles
70% of nominal volt-
age for 25 cycles
> 95% of nominal
voltage for 5 seconds
Mains power quality
should be that of a
typical commercial or
hospital environment.
For interruptions
longer than
10ms, power resets are
possible.
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
The Model P8400 Hemostatix Thermal Scalpel System is intended for use in the electromagnetic en-
vironment specified below. The customer or the user of the Model P8400 Hemostatix Thermal Scalpel
System should assure that it is used in such an
environment.
Immunity Test
Test Level
Compliance
Level
Electromagnetic Environmental Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80MHz to
2.5GHz
3 Vrms
3 V/m
Portable and mobile RF communication
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
RECOMMENDED SEPARATION DIS-
TANCE:
d = 1.2√P
d = 1.2 √P 80 MHz to 800 MHz d = 2.4√P
800 MHz to 2.5 GHz where P is the maxi-
mum 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,
a
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:
NOTE 1
: At 80 MHz and 800 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) tele-
phones 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 model p8400 hemostatix thermal scalpel system is used exceeds the applicable
rf compliance level above, the model p8400 hemostatix thermal scalpel system should be observed to
verify normal operation. if abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the model p8400 hemostatix thermal scalpel system.
b
Over the frequency range 150 khz to 80 mhz, field strengths should be less than 3 v/m.
