Boston Scientific Lumenis Pulse 30H Manual

Lumenis Pulse
TM
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.
1
30H