General Warnings And Caution; General Safety Information; Staff Training - COOK Medical Rhapsody H-30 User Manual

General Warnings and Caution

The Rhapsody H-30 is a holmium laser system, with up to 30 W, for surgical procedures. The
device is manufactured in accordance with Annex II of the 93/42/EEC standard and is identified as
follows:
Device
Name
Models
Device Category
Device Classification
Laser Classification
Manufactured By

General Safety Information

• This manual contains important information about the safe use of the laser system.
• All persons who operate the laser system must understand the operating and safety
instructions specified in this manual (IFU).
• Only authorized individuals with appropriate medical laser training and knowledge should
operate the laser system.
• Only authorized individuals with appropriate laser training and knowledge should service the
laser system.
• Only authorized service personnel should access the internal electrical or optical components.
• The laser system must be completely closed and assembled for normal operation. Only
trained, authorized personnel are allowed to open the external covering panels.
• Access to the user manual should be available in the working area of the laser system.
• All of the warning labels must be kept in good condition.
DO NOT dispose of this product with residential waste. Disposal of this device should
be in accordance with applicable local, regional, and national laws and regulations.
This device cannot be disposed of as municipal waste, but must be separated in
accordance with the WEEE (Waste Electrical and Electronic Equipment) Directive.

Staff Training

The use of the laser system is restricted to medical staff who have received proper training in laser
Cook Medical © 2019
30 W Holmium Laser System
Rhapsody® H-30® Holmium Laser System
HL-30A (20 W), HL-30B, HL-30E
Laser for medical use
II b (according to 93/42/EEC)
IV
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404, USA
Phone: 800.457.4500
www.cookmedical.com
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Chapter 3
Safety, Warnings, and Caution
1-16