Indications For Use; Surgical Applications; Warnings And Risks - COOK Medical H-30 User Manual

Chapter 4
Indications & Instructions for Use

Indications for Use

This section discusses the use of the 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 H-30. A review of prior training is strongly encouraged and recommended.

Surgical Applications

The H-30 Laser System and holmium laser fibers are intended for use in surgical
procedures using open, laparoscopic and endoscopic incision, excision, resection,
ablation, vaporization, coagulation and hemostasis of soft tissue.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization,
coagulation and hemostasis) including:
• Urethral strictures
• Bladder neck incisions (BNI)
• Ablation and resection of bladder tumors, urethral tumors and ureteral tumors
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi
• Treatment of distal impacted fragments of steinstrasse when wire guide cannot
be passed

Warnings and Risks

General warnings and precautions for the H-30 Holmium Laser System
The physician should become fully acquainted with the unique surgical and therapeutic
effects produced with the 2.1 μm wavelength before using the H-30 clinically. These
effects include coagulation, depth of penetration and cutting intensity.
Unless otherwise stated in the specific application section, the physician should begin at
the lowest power and use shorter durations. The surgeon should note the surgical effect
and adjust the settings until the desired result is obtained.
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