30
11. Annex I – EMC statement and guidelines
Guidance and manufacturer’s declaration – electromagnetic immunity
The Keeler Vantage Plus LED is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it 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 material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst.
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
N/A
Mains power quality should be that of a typical commercial or
hospital environment.
Surge.
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
N/A
Mains power quality should be that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines.
IEC 61000-4-11
<5%
U
T
(> 95% dip in
U
T
) for 0.5 cycles
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 s
<5%
U
T
(> 95% dip in
U
T
) for 0.5 cycles
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 s
Mains power quality should be that of a typical commercial or
hospital environment.
If the user of the Keeler Vantage Plus LED requires continued
operation during power mains interruptions, it is recommended
that the charger be powered from an uninterruptible power
supply.
Power frequency
(50/60 Hz) magnetic
field. IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at a level
characteristic of a typical location in a typical commercial or
hospital environment.
Note
U
T
is the a.c. mains voltage prior to application of the test level.
Summary of Contents for Vantage Plus
Page 1: ...1 Vantage Plus and Vantage Plus LED Indirect Ophthalmoscope Instructions for use ...
Page 9: ...9 5 Setting up and using the Vantage Plus ...
Page 12: ...12 5 Setting up and using the Vantage Plus ...
Page 15: ...15 6 Wireless chargers Standard Lithium ...
Page 16: ...16 6 Wireless chargers Slimline Lithium ion ...
Page 17: ...17 6 Wireless chargers ...
Page 18: ...18 6 Wireless chargers ...
Page 20: ...20 6 Wireless chargers wall mounting ...
Page 21: ...21 6 Wireless chargers wall mounting ...
Page 22: ...22 7 SmartPack and WallPack ...
Page 24: ...24 7 SmartPack and WallPack ...
Page 25: ...25 7 SmartPack and WallPack ...
Page 26: ...26 8 LED bulb replacement ...