Warnings And Precautions - General - COOK Medical Rhapsody H-30 User Manual

Warnings and Precautions - General

The information in this section applies to all specialties for which the Rhapsody H-30 Holmium
Laser System is indicated.
The physician should become fully acquainted with the unique surgical and therapeutic effects
produced with the 2100 nm wavelength before using the Rhapsody H-30 Holmium Laser System
clinically. These effects may include coagulation, deep penetration, and intense cutting.
Unless otherwise stated in the specific application section, the physician should begin at the
lowest power and use shorter durations. The physician should note the surgical effect and adjust
the settings until the desired result is obtained.
Adverse events may result from deficiencies in operator skill level, or they may be due to a
concomitantly occurring primary procedure. Careful patient selection and adherence to the
manufacturer's Instructions for Use will help to mitigate risk.
• Extreme caution should be used until the physician is completely familiar with the biological
interactions of the laser with various tissue types.
• Changes in the tissue texture and color are the best indicators of the laser's effect. The
recommended power settings are less important than the observed effect on the tissue.
Specific pulse width should depend on the tissue and is left to the surgeon's preference and
best medical judgment.
• Use the lowest possible power settings that are required in order to achieve the desired effect
on the tissue for treatment.
• Higher energy may be necessary to achieve the desired effect on the tissue if cooled irrigant is
used. Higher power settings may increase the chance of damage to the laser fiber.
• The use of mechanical pressure on the laser fiber does not increase its cutting or vaporization
effects but may induce bleeding, thermal damage, and fiber destruction.
• The risk of combustion, perforation, and laser-induced hemorrhage, any of which can cause
patient death, must be fully explained to the patient prior to surgery.
• Use caution with patients who have had difficulty with previous endoscopic or laparoscopic
procedures.
• The laser should be used only on a tissue target that is fully observable either by direct sight or
through an endoscope.
• Steady the distal end of the fiber at the intended treatment target before depressing the foot
switch.
• Vaporization or excision of anatomical structures in proximity to known critical structures, such
as large arteries, large veins, bowel, ureter, or bladder should be performed carefully to avoid
damage to such structures.
• Electrocautery should be easily accessible in case a bleeding artery or vein needs to be
cauterized.
Cook Medical © 2019
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Chapter 2
Indications
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