BIOMET EBI Bone Healing System, Руководство для врачей и инструкция по применению

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26
Electromagnetic Compatibility
(Continued)
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30%.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the Biomet
®
EBI
Bone Healing System requires
continued operation during
power mains interruptions, it is
recommended that the Biomet
®
EBI Bone Healing System
be powered from an
uninterruptible power
supply (UPS).
± 6 kV contact
± 8 kV air
3 A/m
± 2 kV for power supply lines
± 1 kV for input/output lines
± 1 kV for differential mode
± 2 kV for common mode
< 5% UT ( > 95% dip in UT)
for 0.5 cycle
40% UT ( 60% dip in UT)
for 5 cycles
70% UT ( 30% dip in UT)
for 25 cycles
< 5% UT (> 95% dip in UT)
for 5 sec
Electrostatic
Discharge (ESD)
IEC 610004-2
Electrical Fast
Transient/Burst
IEC 610004-4
Power frequency
( 50/60 Hz )
magnetic field
Surge
IEC 610004-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Immunity Test IEC 60601 Test Level Compliance
Level
The Biomet
®
EBI Bone Healing System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Biomet
®
EBI Bone Healing System should assure
that it is used in such an environment.
Guidance and Manufactures Declaration – Electromagnetic Immunity
Table 2
Electromagnetic
Environment - Guidance