Boston Scientific Lumenis Pulse 30H User manual

1
Lumenis PulseTM 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.

2
General Surgery
•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
ENT Surgery
•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).
Gynecological Surgery
•Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and
coagulation of soft tissue).

3
Gastroenterology Surgery
•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
Pulmonary Surgery
•Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and
coagulation of soft tissue).
Dermatology and Plastic Surgery
•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
•Tattoo removal
•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

4
Contraindications
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.
Specific Contraindications in Urology
•Carcinoma of the prostate.
Specific Contraindications in Gynecology
•Septic peritonitis
•Intestinal obstruction.
•Septic shock.
•Resection or excision of large, highly vascularized organs.
Warnings and Precautions
This section contains warnings and precautions that are applicable to surgical procedures specifically
related to the use of this system
•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.
•Lumenis medical lasers and laser delivery systems are intended solely for physicians trained in the
use of these instruments.
•Read this operator manual carefully. Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous laser radiation exposure.
•Select the appropriate laser safety eyewear, for the specific laser in use, by verifying that the above
specifications are indicated on the laser safety eyewear that is at your disposal.
•Always verify that the delivery device 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.
•Never look directly into any optical fiber, handpiece, probe or laser system aperture while the laser is
energized. Severe eye damage could occur. Turn off the laser before inspecting any delivery system
or laser components.
•Never open the laser console protective covers. Opening the covers will expose the user to high
voltage components, the laser resonator, and possible laser radiation. Only Lumenis-certified service
technicians are qualified to work inside the console.
•Do not operate the laser system if any of the cords are faulty or frayed. The laser system should
undergo routine inspection and maintenance per Lumenis manufacturer’s recommendations and
institutional standards.
•To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.

5
•Do not use this device in the presence of flammables or explosives, such as volatile anesthetics,
alcohol, certain surgical preparation solutions, and similar substances. An explosion and/or fire could
occur.
•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.
•Smoke evacuation may be required if using the laser system in open-air procedures.
•When using a fiber-optic delivery device, always inspect the fiber-optic cable to ensure that it has not
been kinked, punctured, fractured, or otherwise damaged. The fiber-optic cable may be damaged if
stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled. Do not clamp the cable
with a hemostat or other instruments. If sterile tape is used, always remove the tape before lifting
the cable. A damaged fiber-optic cable 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 optical 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 must always be in Standby mode. Maintaining the laser in
Standby mode prevents accidental laser exposure if the footswitch is inadvertently pressed.
•To prevent accidental laser discharge, always make sure that the footswitch is not being operated
while connecting the delivery system.
•Never place hands or other objects in the path of the laser beam. Severe burns could occur.
•Only the person directing the aim of the laser beam should have access to the laser footswitch. Use
caution pressing the laser footswitch when it is in proximity to footswitches for other equipment.
Verify the footswitch pressed is the correct one in order to avoid accidental laser exposure.
•Never discharge the laser without a target to absorb it and without consideration given to what lies
behind the target. Place energy-absorbing material behind the target tissue when aiming the laser at
an oblique target.
•Unauthorized use of this system may expose the operator/patient to potential electrical energy and
laser radiation hazards.
•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.
•The laser system should be used only on tissues that are fully observable. Do not use the laser if the
desired target is not visible. All available measures to visualize the target tissue (e.g. copious
irrigation, hemostasis) should be taken.
•When using endoscopic equipment confirm that the tip of the fiber-optic delivery device extends at
least 6 mm beyond the end of the scope during laser treatment. Activating the laser when the tip of
the delivery device 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

6
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.
•Baskets, guidewires, and other surgical accessories may be damaged by direct contact with the laser
treatment beam.
Adverse Events/Complications
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.
Precautions can be found in the product labeling supplied with each device.
Boston Scientific acquired the global surgical business of Lumenis Ltd.
Lumenis PulseTM 30H is the registered product name. Lumenis PulseTM 30H is manufactured and sold by
Boston Scientific. Lumenis is a registered trademark of Lumenis Be.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
All trademarks are the property of their respective owners.
©2022 Boston Scientific Corporation or its affiliates. All rights reserved.
URO-1220405-AA JAN 2022