Bolder Surgical CoolSeal Generator Instrucciones De Uso página 30

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The CoolSeal Generator is intended for use in the electromagnetic environment specified below. The customer or the user
™
of the CoolSeal
™
Immunity test
Electrostatic
Discharge IEC/EN
61000-4-2
Radiated Immunity
IEC 61000-4-3:2006
+ A1:2008 +A2:2010
Proximity field
from RF wireless
communications equipment
IEC 61000-4-3
Conducted
Immunity
(AC Power)
(I/O Lines)
IEC/EN 61000-4-6
Electrical Fast
Transients (AC Power)
IEC/EN 61000-4-4
Surge Line to Line
(AC Power)
IEC/EN 61000-4-5
Magnetic Immunity
IEC/EN-61000-4-8
Voltage Dips & Interruptions
IEC/EN 61000-4-11
Bolder Surgical
Generator should ensure that it is used in such an environment.
IEC 60601 test level
± 8 kV contact discharge
± 2, 4, 8 & 15 kV air
discharge
80 MHz - 6 GHz
3 V/m
80% @ 1 kHz
28 V/m Spot
frequencies
385 MHz – 2.7 GHz
Pulse Modulation
Per Table 9 of the IEC
60601-1-2 standard
0.15 - 80 MHz
3 Vrms & 6Vrms in ISM Band
1 kHz
AC Mains
± 2 kV AC mains
± 1 kV - I/O lines 5/50 5 kHz & 100kHz
± 1 kV
Line to Line
Line to Ground
30 A/m
50/60 Hz
0% UT 0.5 cycle 0% UT 1 cycle
70% UT 25 cycles
0% UT 5 Sec
± Compliance Electromagnetic Environment – Guidance
level
± 8 kV contact Floors should be wood, concrete, or ceramic tile.
discharge If floors are covered with synthetic material, the
± 2, 4, 8 & 15 kV relative humidity should be at least 30%.
air discharge
80 MHz - 6 GHz Portable and mobile RF communications
3 V/m equipment should be used no closer to any part
of the CoolSeal
80% @ 1 kHz the recommended separation distance calculated
from the equation applicable to the frequency of
28 V/m Spot the transmitter.
frequencies
385 MHz – 2.7
GHz Pulse
Modulation
Recommended separation distance
See table on
next page of d = [2]√P
frequency ranges where P is the maximum output power rating of and test the transmitter in watts (W) according to the
conditions for transmitter manufacturer and d is the recommended
RF wireless separation distance in meters (m). Field strengths
communications from fixed RF transmitters, as determined by an
equipment electromagnetic site survey
compliance level in each frequency range
0.15 - 80 MHz The ISM (industrial, scientific and
3 Vrms & 6Vrms medical) bands between 0,15 MHz
in ISM Band and 80 MHz are 6,765 MHz to
1 kHz 6,795 MHz; 13,553 MHz to 13,567
AC Mains MHz; 26,957 MHz to 27,283 MHz;
and 40,66 MHz to 40,70 MHz.
± 2 kV AC mains Mains power quality should be that of a typical
± 1 kV - I/O lines commercial or hospital environment. 5/50 5 kHz &
100kHz
± 1 kV Mains power quality should be that of a typical
Line to Line commercial or hospital environment.
Line to Ground
30 A/m Power frequency magnetic fields should be at
50/60 Hz levels characteristic of a typical location in a typical
commercial or hospital environment.
0% UT 0.5 cycle If the user of CoolSeal 0% UT 1 cycle ued operation during power mains interruptions,
70% UT 25 cycles it is recommended that the CoolSeal Generator be
0% UT 5 Sec powered from an uninterruptible power supply
or a battery.
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Generator, including cables, than
™
, must be less than the
a
b
Generator requires contin-
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en - CoolSeal™ Generator
.