COOK Medical Rhapsody H-30 User Manual page 14

• The flammability of methane gas must be considered when treating the perianal area.
• Tissue perforation can occur if excessive laser energy is applied, whether through excessive pulse energy or
extended laser application dwell time.
• Fiber tips are sharp; perforation may occur by mechanical means (poking).
• When risk of air embolism is present, such as when one is cutting or vaporizing organs with large vascular
structures, always use fluid cooling.
• Screen tumors that are in close proximity to known arteries or veins by pretreatment workups to precisely
locate the tumors.
• When radiotherapy and laser therapy are used concurrently, extra precautions should be taken, including
conducting more stringent postoperative monitoring. Patients who have undergone radiotherapy present a
greater risk of perforation and tissue erosion.
• Discontinue laser therapy immediately if the patient develops cardiopulmonary problems.
• Cook does not have clinical information about or experience with the use of the Rhapsody H-30 Holmium
Laser System on pregnant women or nursing mothers.
• Patients who have experienced discomfort during previous laser treatment may require analgesics.
• Anesthesia considerations: If the laser is used in an oxygen-rich environment (such as in endobronchial use),
oxygen concentrations should not exceed 21-30% in order to diminish the fire hazard. Endotracheal tubes
should be either non-combustible or wrapped with reflective tape.
• If the physician desires to use the delivery system without a contact probe or scalpel attached, the physician
must be aware of the increased risk of back-scatter and forward-scatter.
• Because of possible fluid absorption risks, patients with cardiovascular disorders should be carefully
evaluated as candidates for this procedure.
• When appropriate, moistened sponges should be placed on the tissues and instrumentation surrounding the
laser area to help dissipate incident laser energy and inadvertent heat production.
• Endoscopic treatment may result in adverse reactions such as stone migration, burns, hemorrhage,
laceration, infection, inflammation, pain, ureteral avulsion, air embolism, pneumothorax, or bladder, ureteral,
or bile duct perforation. In extreme cases, death may occur due to procedural complications, concurrent
illness, or the application of laser radiation.
• Adverse events reported in clinical literature in the context of holmium laser procedures include subcapsular
renal hematoma, bladder neck contracture, urethral stricture, residual adenoma, hematuria, dysuria, acute
urinary retention, urinary incontinence, bladder neck stenosis, difficult micturition, urethral or bladder injury,
ureteric orifice injury, hydronephrosis, steinstrasse, recatheterization, clot retention, acute epididymitis, septic
shock, hypoxemia, mucosal injury, pancreatitis, cholangitis, biliary stricture, and ascites.
Cook Medical © 2019
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Chapter 2
Indications
1-13