Boston Scientific Lumenis Pulse 30H - User Manual

1
Lumenis Pulse
TM
30H
Prescriptive Information
Refer to the device user manual for complete instructions on device use.
Intended Use/Indications for Use
The Lumenis Pulse 30H System with fibers and accessories are intended for use in surgical procedures
involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of
soft tissue in medical specialties including: urology, urinary lithotripsy, arthroscopy, discectomy, ENT
surgery, gynecological surgery, pulmonary surgery, gastroenterology surgery, dermatology and plastic
surgery, and general surgery.
The Lumenis Pulse 30H System with fibers and accessories are indicated for use in the performance of
specific surgical applications as follows.
Urology
• Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI),
holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP),
holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment
of benign prostatic hypertrophy (BPH).
• Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of
soft tissue) including treatment of:
• Bladder
• Superficial and invasive bladder, urethral and ureteral tumors
• Condylomas
• Lesions of external genitalia
• Ureteral and penile hemangioma
• Ureteral strictures
• Bladder neck obstructions
• Urinary Lithotripsy including:
• Endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including
cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones.
• Treatment of distal impacted fragments of steinstrasse when guidewires cannot be passed.
Arthroscopy
• Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and
large joints of the body, excluding the spine, including:
• Meniscectomy
• Plica removal
• Ligament and tendon release
• Contouring and sculpting of articular surfaces
• Debridement of inflamed synovial tissue (synovectomy)
• Loose body debridement
• Chondromalacia and tears
• Lateral retinacular release
• Capsulectomy in the knee
• Chondroplasty in the knee
• Chondromalacia ablation
• Discectomy including:
• Percutaneous vaporization of the L4-5 and LS-S1 lumbar discs of the vertebral spine; open and
arthroscopic spine procedures; foraminotomy.

Summary

Prescriptive Information

Intended Use and Indications

Details the intended surgical procedures and applications for the Lumenis Pulse 30H System with fibers and accessories.

Urology Applications

Lists specific urological procedures including TUIP, BNI, HoLAP, HoLEP, HoLRP, and lithotripsy for BPH and stones.

Arthroscopy Applications

Covers arthroscopic procedures for various joints excluding the spine, such as meniscectomy, plica removal, and ligament release.

General Surgery Applications

Encompasses open, laparoscopic, and endoscopic general surgery procedures like cholecystectomy, appendectomy, and skin incision.

ENT Surgery Applications

Details endoscopic and endonasal surgeries for sinuses, nasal tissues, and pharyngeal/laryngeal structures.

Gynecological Surgery Applications

Specifies open and laparoscopic gynecological surgeries involving ablation, vaporization, incision, excision, and coagulation.

Gastroenterology Surgery Applications

Includes open/endoscopic gastroenterology procedures for conditions like gallstones, polyps, ulcers, and tumors.

Pulmonary Surgery Applications

Covers open and endoscopic pulmonary surgery for cutting, ablation, vaporization, incision, excision, and coagulation.

Dermatology and Plastic Surgery Applications

Details dermatologic and aesthetic procedures for scars, vascular lesions, rosacea, warts, and skin lesions.

Contraindications

Specific Urology Contraindications

Lists specific contraindications for urology, notably carcinoma of the prostate.

Specific Gynecology Contraindications

Outlines contraindications in gynecology, including septic peritonitis and intestinal obstruction.

Warnings and Precautions

Laser Safety and Operation

Covers essential safety measures, including eyewear, proper connections, and avoiding direct beam exposure.

System Maintenance and Electrical Safety

Details precautions for system maintenance, cord integrity, and electrical grounding.

Procedure-Specific Precautions

Addresses precautions related to flammables, fire hazards, fiber-optic cable inspection, and aiming beam verification.

Patient and Tissue Safety

Emphasizes caution with tissue interaction, flammable gases, target visualization, and scope protection.

Boston Scientific Lumenis Pulse 30H Specifications