Detailed Indications for Use
Lumenis Pulse 120H UM-10012510 Rev. F
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• Patients may experience bleeding at the site of laser therapy. Post
treatment hematocrits are recommended to identify this potential
complication.
• Sepsis can result from performing any surgical procedure. If a question
of sepsis exists, appropriate evaluations should be made.
• Perforation may occur as a result of laser treatment. To diagnose
perforations, patients must be carefully followed post-operatively with
appropriate tests.
• As with any conventional laparoscopic surgery, the use of gas to
insufflate the abdomen may lead to a gas embolus. In the extreme case,
death may result from an embolus. The use of carbon dioxide gas for
insufflation will minimize patient risk, as it is highly soluble in blood.
Insufflation pressure should be set to minimum settings for effective
insufflation.
Detailed Indications for Use
The Lumenis Pulse 120H system with delivery devices 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; E.N.T. surgery; gynecological surgery;
pulmonary surgery; gastroenterology surgery; dermatology and plastic
surgery and general surgery.
The Lumenis Pulse 120H system with delivery devices and accessories
are indicated for use in the performance of specific surgical applications
as follows.