Indications For Use; Contraindications - COOK Medical Rhapsody H-30 User Manual

Indications
This section discusses the use of the Rhapsody H-30 Holmium Laser System in clinical applications.
The information is provided by specialty and includes procedural recommendations, along with
specific indications and contraindications. The information provided in this section is not all-
inclusive and is not intended to replace physician training or experience.
Only physicians and staff who have been appropriately trained and who are thoroughly familiar
with the instructions and safety precautions provided in this manual should operate the system. A
review of prior training is strongly encouraged and recommended.

Indications for Use

The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation,
vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open
surgical, laparoscopic, percutaneous, or endoscopic procedures in urological, gynecological,
gastroenterological, or pulmonary applications.

Contraindications

The Rhapsody H-30 Holmium Laser System should only be used in conditions where its use
is appropriate and its efficacy has been proven. A qualified physician should perform clinical
applications.
The use of the Rhapsody H-30 Holmium Laser System is contraindicated for patients:
• Who are inappropriate candidates for laser surgery
• Where appropriate anesthesia is contraindicated by patient history
• Whose general medical condition contraindicates surgical intervention
• Where tissue (especially tumors) is calcified
• Requiring hemostasis of vessels over approximately two millimeters in diameter
• Where laser therapy is not considered the treatment of choice
• Where any irrigant other than physiological saline or sterile water is used
The use of the Rhapsody H-30 Holmium Laser System is contraindicated for the treatment of
menorrhagia in the following:
• Patients who desire future childbearing potential
• Patients who have any medical condition that contraindicates hysteroscopy, such as active
pelvic inflammatory disease
• Patients who have indications of precancerous pathology
Cook Medical © 2019
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Chapter 2
Indications
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