Lumenis Pulse™ 30H Holmium Laser System

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, endo nasal surgery, gynecological surgery, pulmonary surgery, gastroenterology surgery, dermatology 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.

• 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 (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 L5–S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy.

• Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
  • Cholecystectomy
  • Lysis of adhesions
  • Appendectomy
  • Biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon
  • Skin incision
  • Tissue dissection
  • Excision of external tumors and lesions
  • Complete or partial resection of internal organs, tumors and lesions
  • Mastectomy
  • Hepatectomy
  • Pancreatectomy
  • Splenectomy
  • Thyroidectomy
  • Parathyroidectomy
  • Herniorrhaphy
  • Tonsillectomy
  • Lymphadenectomy
  • Partial nephrectomy
  • Pilonidal cystectomy
  • Resection of lipoma
  • Debridement of decubitus ulcer
  • Hemorrhoids
  • Debridement of statis ulcer
  • Biopsy

• Endoscopic endonasal/sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
  • Partial turbinectomy
  • Ethmoidectomy
  • Polypectomy
  • Maxillary antrostomy
  • Frontal sinusotomy
  • Sphenoidotomy
  • Dacryocystorhinostomy (DCR)
  • Functional endoscopic sinus surgery (FESS)
• Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
  • Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues
  • Tonsillectomy
  • Adenoidectomy

• Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).

• Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including:
  • Gall bladder calculi
  • Biliary/bile duct calculi
  • Benign and malignant neoplasm
  • Polyps
  • Colitis
  • Ulcers
  • Angiodysplasia
  • Hemorrhoids
  • Varices
  • Esophagitis
  • Esophageal ulcer
  • Mallory-Weiss tear
  • Gastric ulcer
  • Duodenal ulcer
  • Non-bleeding ulcer
  • Gastric erosions
  • Colorectal cancer
  • Gastritis
  • Bleeding tumors
  • Pancreatitis
  • Vascular malformations
  • Telangiectasias
  • Telangiectasias of the Osler-Weber-Rendu disease

• Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue).

• Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including:
  • Scars
  • Vascular lesions
  • Port wine stains
  • Hemangioma
  • Telangiectasia of the face and leg
  • Rosacea
  • Corns
  • Papillomas
  • Basal cell carcinomas
  • Lesions of skin and subcutaneous tissue
  • Plantar warts
  • Periungual and subungual warts
  • Debridement of decubitus ulcer
  • Skin tag vaporization

The use of a laser instrument for an application is at the physician’s discretion except in cases where the indication has been contraindicated

• Inability to receive endoscopic or laparoscopic treatment.
• Intolerance to anesthesia.
• Resection or excision of large, highly vascularized organs.

• Carcinoma of the prostate.

• Septic peritonitis
• Intestinal obstruction.
• Septic shock.
• Resection or excision of large, highly vascularized organs.

NOTE: Lumenis has no clinical information concerning the safety of laser treatment on pregnant or nursing women

This section contains warnings and precautions that are applicable to surgical procedures specifically related to the use of this system

• Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1 μm) wavelength.
• Incorrect treatment settings can cause serious tissue damage. Therefore, it is recommended that you use the lowest acceptable treatment settings until familiar with the instrument’s capabilities. Use extreme caution until the biological interaction between the laser energy and tissue is thoroughly understood.
• Due to interaction between flammable gases in the operating field and the laser energy a flash fire may occur. Therefore, during laser procedures, measures to minimize this potential hazard should be practiced (e.g., avoid administration of inhaled general anesthetics; reduce oxygen levels during mechanical ventilation, use of laser-resistant endotracheal tubes). The flammability of methane gas must also be considered when treating in or near the perianal area.
• When using endoscopic equipment confirm that the tip of the fiber extends at least 6 mm beyond the end of the scope during laser treatment. Activating the laser when the tip of the fiber is within the scope can result in penetration of holmium laser energy through the scope and destruction of the scope.
• Use of the laser system on anatomical structures in proximity to known critical structures, such as large arteries, veins, bowel, ureter, bladder, nerves, etc., should be performed carefully to avoid inadvertent or unintended damage of such structures. If applicable, maintain irrigation in the treatment area to reduce heat accumulation.
• Use caution when treating patients who have recently undergone radiotherapy. Such patients may be at greater risk of tissue perforation or erosion.
• Highly vascularized anatomical structures should be approached with caution, taking into account the limited coagulative properties of the laser. Electrocautery and/or suture (ligature) should be easily accessible in the event that a bleeding vessel is larger than possible to control with the laser. The risk of bleeding may be higher in patients taking anticoagulants/platelet aggregates.

• Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.
• Always verify that the fiber is properly connected to the laser. An improper connection may result in an inadvertent secondary laser beam. Severe eye or tissue damage could occur.
• Never substitute prescription eyewear for the appropriate laser safety eyewear, as severe eye damage could occur. Prescription eyewear can concentrate the laser light to the eye and/or can be shattered by a high power density beam, possibly causing severe eye damage.
• Use caution when performing procedures around the eyes. Severe and irreversible eye damage and scarring may occur from direct or indirect exposure to the treatment beam. The predominant ocular structures at risk are dependent on the laser wavelength in use. In general, visible and near-infrared wavelengths are most damaging to the retina, while ultraviolet or infrared wavelengths are most damaging to the cornea and sclera. Severity of injury depends on how concentrated or diffused the treatment beam is and the length of exposure. A thorough understanding of the specific ocular risks and safety precautions for each laser wavelength is necessary to ensure the safety of the patient and operating personnel.
• The treatment beam can ignite most non-metallic materials. Use fire retardant drapes and gowns. The area around the treatment site can be protected with towels or gauze sponges moistened with sterile saline solution or sterile water. If allowed to dry, protective towels and sponges can increase the potential fire hazard. A UL-approved fire extinguisher and water should be readily available.
• When performing procedures in the perianal area, the flammability of methane gas must be considered. Moistened sponges should be inserted into the rectum.
• When using a fiber, always inspect it to ensure that it has not been kinked, punctured, fractured, or otherwise damaged. The fiber may be damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled. Do not clamp the fiber with a hemostat or other instruments. If sterile tape is used, always remove the tape before lifting the fiber. A damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.
• Never deliver the treatment beam to the target tissue if the aiming beam integrity has not been verified; the fiber may be damaged. A damaged fiber may cause accidental laser exposure to the treatment room personnel or patient, and/or fire in the treatment room.
• Except during actual treatment, the laser system must always be in Standby mode. Maintaining the laser system in Standby mode prevents accidental laser exposure if the footswitch is inadvertently pressed.
• Verify that all persons in the treatment room are wearing appropriate laser safety eyewear before setting the system to Ready mode.
• To avoid possible damage to the system, use only qualified Lumenis delivery systems. Using other than Lumenis delivery systems may jeopardize safe operation or damage the laser system and will void your Lumenis warranty or service contract.
• Never inspect the fiber while it is connected to the laser system. Accidental laser exposure can cause severe eye damage.
• Do not connect any USB flash drives to the system during operation; doing so may negatively affect performance.
• Do not use the fiber if the aiming beam is set to high intensity and is still weak or not visible; the fiber may be damaged. A damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room.
• Do not use the laser system or fiber if the aiming beam has not been verified. Verifying the aiming beam integrity is extremely important for the safe operation of your laser equipment.
• Do not use the laser system or fiber if the aiming beam is not visible. Operating the laser system without the aiming beam may result in laser exposure to non-target tissue and possible injury.
• Always check your parameter settings on the screen before setting the system to Ready mode.

The following is a list of general complications that are related to surgery and within this context, laser surgery. The potential complications encountered in endoscopic laser surgery are the same as those normally 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.