8. Repeat steps 5 through 7 for the following settings as well:
a. Short pulse width mode, 10 Hz and 2.0 J. (This step applies to both 20 W and
30 W models.)
b. Short pulse width mode, 10 Hz and 3.0 J. (This step applies to 30 W models only)
Electromagnetic Emission and Interference
IMPORTANT! Medical electrical devices are subject to special precautions with regard to
electromagnetic compatibility (EMC) according to IEC 60601-1-2. Make sure you observe the notes
on EMC for installation and operation. Medical electrical devices can be influenced by mobile RF
communication devices (i.e., mobile phones). If it is necessary to stack the devices or place them next
to each other, and RF interference is observed, verify that the Rhapsody H-30 Holmium Laser System is
operating normally. If abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the laser system.
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.
Emission Test
RF Emission
CISPR 11
RF Emission
CISPR 11
Harmonic Emission
IEC 61000-3-2
Voltage Fluctuation / Flicker
Emission
IEC 61000-3-3
Cook Medical © 2019
IEC 60601-1-2 Table 1
Compliance
Electromagnetic Environment - Guidance
Group 1
The Rhapsody H-30 Holmium Laser System is not intended
to use or produce RF energy. Therefore its emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.
Class A
The Rhapsody H-30 Holmium Laser System is not suitable
for installation in all buildings, including domestic buildings
and those directly connected to the public supply network
Not Applicable
in low tension. It should only be installed in buildings like
hospitals with dedicated supply systems.
Not Applicable
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Chapter 4
Installation
1-27