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safety, operation of the Rhapsody H-30 Holmium Laser System, and the identification and use of
appropriate personal protective equipment.
Working Area
This Rhapsody H-30 Holmium Laser System is a class 4 laser and must be used in a specific
nominal hazard zone (NHZ) or working area that is defined and delimited in accordance with all
applicable local and international standards (IEC60825-1:2007, ANSI Z136.3). In general clinical
operation, the working area is typically defined as the operating room.
Repair and Modifications of the Device
Only authorized service personnel should perform repairs and maintenance. Constructive
modifications are not permitted.
NOTE
: Unauthorized repair, maintenance, and/or modifications to the laser system will void the
warranty.
WARNING!
ments other than those specified herein may result in hazardous radiation exposure.
CAUTION
: The use of controls or adjustments or the performance of procedures other than those
specified herein may result in hazardous radiation exposure.
Eye and Skin Exposure
The working laser beam of the Rhapsody H-30 Holmium Laser System is invisible and, if exposed
to the eyes, may cause sight loss. The skin can resist a significantly higher amount of laser energy
than the eyes, but the laser beam can also seriously burn the skin.
A danger exists in any case of:
•
Direct laser radiation
•
Reflected laser radiation
•
Diffused laser radiation
WARNING!
appropriate laser safety eyewear.
WARNING!
ing the fiberoptics, or failing to follow the fiberoptics installation procedure may lead
to damage to the fiber or delivery system and may result in harm to the patient or
operator.
Use protective eyewear with either of the following specifications:
•
I 2100 L2 (EUR) @ 2100NM
•
OD 4 (US) @ 2100NM
Cook Medical © 2019
Performing any procedures, operating any controls, or making any adjust-
All personnel present in the laser working area must wear
Incorrectly inserting the fiberoptics, sharply bending or improperly secur-
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Chapter 3
Safety, Warnings, and Caution
1-17
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