Stryker Visum User Manual

37
S
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment
specied below. The customer or the user of the Visum® Blade LED Surgical Light System 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 oors 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
± 1 kV for input/
output lines
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)
± 2 kV line(s) to
earth
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 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 s
<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 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Visum®
Blade LED Surgical Light System
requires continued operation during
power mains interruptions, it is
recommended that the Visum® Blade
LED Surgical Light System be powered
from an uniterruptible power supply or
battery.
Power frequency
(50/60 Hz) magnetic
eld
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds
should be at levels 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.

Stryker Visum Specifications

General

Category	Medical Equipment
Type	Mobile C-Arm
Manufacturer	Stryker
Model	Visum
Power Requirements	50/60 Hz
Applications	Orthopedic, Pain Management