User's Manual

Lumenis
®
Pulse
TM
50H / 100H Laser Systems Detailed Indications for Use
UM-20006520DE, Rev. A Page 26
encountered in conventional endoscopic surgery. Refer to updated
literature for specific procedure related complications.
• As with conventional surgery, the possibility of complications and
adverse events, such as chills, fever, edema, hemorrhage, inflammation,
tissue necrosis, or infection may occur following treatment. In extreme
cases, death may occur due to procedural complications, concurrent
illness, or laser application.
• As with any surgical procedure there is a possibility of infection or
scarring. Therefore, appropriate pre and post-surgical care should
always be practiced.
• As with any conventional surgery discontinue laser treatment
immediately if the patient develops any cardiopulmonary problems.
• As with any conventional surgery, acute pain may occur immediately
following laser therapy and may persist for as long as 48 hours.
• Immediately following laser therapy, the patient may experience fever
and leukocytosis, which are commonly associated with tissue
destruction. These generally resolve without treatment. Remnants of
destructed tissue may become necrotic or infected. If a question of
infection exists, appropriate treatment should be carried out.
• 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 50H and 100H 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; endo-nasal surgery;