11.1 EMC REQUIREMENTS FOR THE MODEL 3000
TABLE 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Model 3000 Phacoemulsification System (Model 3000) is intended for use in the electromagnetic environment specified in this
table. The customer or user of the Model 3000 should ensure that the system is used in such an environment.
EMISSION T
EST
COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF Emissions CISRP 11
Group 1
The Model 3000 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic environment.
RF Emissions CISRP 11 Class A
The Model 3000 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic Emissions IEC 61000-3-2 Class A
Voltage Fluctuations/Flicker Emissions IEC
61000-3-3
Complies
TABLE 2: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Model 3000 is intended for use in the electromagnetic environment specified in this table.
The customer or user of the Model 3000 should ensure that the system is used in such an environment.
IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
Electrostatic Discharge
(ESD)
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 covered with synthetic
materials, the relative humidity should be at
least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
± 2 kV
(Power supply lines)
± 1 kV
(Input/Output lines)
± 2 kV
(Power supply lines)
± 1 kV
(Input/Output lines)
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
2 kV (Line to Ground)
1 kV (Line to Line)
2 kV (Line to Ground)
1 kV (Line to Line)
Voltage Dips, Short
interruptions, and voltage
variations. Power supply
input lines.
IEC 61000-4-11
< 5% U
T
< 95% dip in U
T
for 0.5 cycle
40% U
T
60% dip in U
T
for 5 cycles
70% U
T
30% dip in U
T
for 25 cycles
< 5% U
T
< 95% dip in U
T
for 5 sec
< 5% U
T
< 95% dip in U
T
for 0.5 cycle
40% U
T
60% dip in U
T
for 5 cycles
70% U
T
30% dip in U
T
for 25 cycles
< 5% U
T
< 95% dip in U
T
for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment. If
the user of the Model 3000 requires
continued operation during power mains
interruptions, it is recommended that the
Model 3000 be powered from an
uninterruptible power supply or battery.
Power Frequency
(50 / 60Hz)
Magnetic Field
IEC 61000-4-8
3 A(rms)/m
3 A(rms)/m
Power Frequency Magnetic Fields should be
at levels characteristic of a typical location in
a typical commercial or hospital environment.
NOTE: (U
T
) is the AC Mains voltage prior to application of the test level.
To Next Page
Loading...