COOK Medical Rhapsody H-30 User Manual page 29

Guidance and Manufacturer's Declaration - Electromagnetic Emission
The Rhapsody H-30 Holmium Laser System is intended for use in the electromagnetic environment specified
below. The customer or the end user of the laser system should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level
Electrostatic ±6 KV Contact
Discharge (ESD) ±8 KV Air
IEC 61000-4-2
Electrical Fast ±2 KV for power supply
Transient / Burst lines
EC 61000-4-4 ±1 KV for I/O lines
Surge ±1 KV differential mode
IEC 61000-4-5 ±2 KV common mode
Voltage Dips, Short <5% Ut for 0.5 cycles
Interruptions and 40% Ut for 5 cycles
Voltage Variations on 70% Ut for 25 cycles
Power Supply Input <5% Ut for 5 seconds
Lines Note: Ut is the AC mains
IEC 61000-4-11 voltage prior to the
application of the test
level.
Power Frequency 3 A/m
(50/60 Hz) Magnetic
Field
IEC 61000-4-8
Cook Medical © 2019
IEC 60601-1-2 Table 2
Compliance Level
±6 KV Contact
±8 KV Air
±2 KV for power supply
lines
N/A for I/O lines
±1 KV differential mode
±2 KV common mode
<5% Ut for 0.5 cycles
40% Ut for 5 cycles
70% Ut for 25 cycles
<5% Ut for 5 seconds
3 A/m
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Electromagnetic
Environment Guide
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30%.
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 Rhapsody H-30
Holmium Laser System requires
continued operation during
power mains interruptions, it
is recommended that the laser
system be powered from an
uninterruptible power supply or
battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
Chapter 4
Installation
1-28