Zimmer TotalShield II Manual De Instrucciones página 8

EMC GUIDANCE AND DECLARATION - EM IMMUNITY/DISTURBANCES
Guidance and manufacturer's declaration – electromagnetic immunity
The TotalShield II Surgical Helmets are intended for use in the electromagnetic environments specified below. The customer or the user should assure that they
are 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
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
EMC GUIDANCE AND DECLARATION - EM EMISSIONS/RF
Guidance and manufacturer's declaration – electromagnetic immunity
TotalShield II
The Surgical Helmets are intended for use in the electromagnetic environments specified below. The customer or the user should assure that they
are used in such an environment.
IMMUNITY IEC 60601
TEST TEST LEVEL
3 Vrms
Conducted RF
150 kHz to 80
IEC 61000-4-6
MHz
3 V/m
Radiated RF
80 MHz to 2.7
IEC 61000-4-3
GHz
NOTES
• At 80 MHz and 800 MHz, the higher frequency range applies.
• 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) telephone 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
are used exceeds the application RF compliance levels above, the
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
IEC 60601 TEST LEVEL COMPLIANCE LEVEL
± 2, ± 4, ± 8 kV contact
± 2, ± 4, ± 15 kV air
± 2 kV for Power Supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
100% drop, 0.5 periods,
0°, 45°, 90°, 135°,
180°, 225°, 270°, 315°
30% dip, 25/30 periods
100% dip, 1 period
Voltage Interruptions (all input
current)
30 A/m
COMPLIANCE
LEVEL
3Vrms
3 V/m
ELECTROMAGNETIC ENVIRONMENT –
GUIDANCE
Floors should be wood, concrete or ceramic tile.
± 2, ± 4, ± 8 kV contact
If floors are covered with synthetic materials, the relative
humidity should be at least 30%.
± 2, ± 4, ± 15 kV air
N/A ~ AC Power Mains power quality should be that of a typical
commercial or hospital environment.
N/A
N/A ~ AC Power Mains power quality should be that of a typical
commercial or hospital environment.
N/A
~ AC Power Mains quality should be that of a typical
commercial or hospital environment. If the user requires
N/A
continued operation during ~ Power Mains interruptions, it
is recommended to be powered from an uninterruptible
Power Supply or a Battery.
N/A
N/A
N/A
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
30 A/m
or hospital environment.
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
Portable and mobile RF communications equipment should be used no closer to any part of
the TotalShield II Surgical Helmets, 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 2.7 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the
d
transmitter manufacturer and is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
should be less than the compliance levels in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol
TotalShield II
Surgical Helmets should be observed to verify normal operation. If
8
TotalShield II
Surgical Helmets
TotalShield II
Surgical Helmets.