AMS GreenLight XPS Laser System Operators Manual Rev AA

12.3 Procedure...17 12.4 After the Procedure...18 13 TECHNICAL DATA...19 13.1 Safety Classifications and Electromagnetic Compatibility...19 14 MAINTENANCE...22 14.1 Care of the Console...22 14.2 Preventative Maintenance...22 14.3 Coolant Refill Instructions...22 14.4 Instructions How to Refill Coolant...22 14.5 End of Useful Life...23 15 TROUBLESHOOTING...23 15.1 Courtesy Messages...23 15.2 Service Prompts...24 16 warranty...25 16.1 Limitation of Warranty...25 16.2 Additional Terms of Warranty for Mobile Systems...25

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16.3 Transport of the System...25

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ONLY Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. WARNING: Users of the GreenLight XPS™ Laser System should read this manual thoroughly before attempting surgical procedure. Pay attention to all warnings, contraindications, precautions, and adverse events in this manual and other related material. Failure to thoroughly understand and follow all instructions may result in harm to the patient or the user of the laser system. 1 device description The GreenLight XPS Laser System is designed for the vaporization and coagulation of soft tissue using light. One example procedure is the endoscopic (transurethral) resection of the prostate for the treatment of Benign Prostatic Hyperplasia (BPH). The laser system consists of a console, which generates the green laser light and a fiber optic delivery device that transmits laser light from the console to the patient. This laser system is not intended to treat prostate cancer. 1.1 Console The console is a diode-pumped solid-state laser utilizing Nd:YAG laser gain medium and Acousto-Optic Q Switch. The primary wavelength is 1064 nm. Frequency-doubling crystal is used to generate a 532 nm output beam. Quasi-CW pulse repetition rate is 23.6 kHz. Pulse duration is approximately 100 ns. Pulse energy is approximately 8 mJ at maximum power (180 W). The console generates visible green 532 nm laser light. In vaporization mode, the power settings range from 20 W to a maximum power determined by the fiber delivery device. In coagulation mode, the power settings range from 5 W to 40 W. The console features a plug and play capability that self-adjusts to the facility’s supply voltage, eliminating the need for electrical modifications of the operating facility. The console includes internal cooling mechanisms ensuring safe operating temperatures with no external water connection. Laser energy emission and console status changes are activated through a surgeon-controlled, color-coded footswitch or console touchscreen feature. 1.2 FiberLife The console is equipped with the FiberLife feature. The FiberLife feature continuously monitors the temperature of the tip of the fiber and momentarily stops the laser emission when the fiber gets too hot. In most cases, this will prevent damage to the fiber if tissue or vapor bubbles accumulate on the tip or there is excessive heating of the fiber. In most cases, the laser will turn back on immediately and the procedure continues without interruption. There will be noticeable blinking of the working beam. If the FiberLife feature is activated continuously, vaporization efficiency will be significantly reduced. In this case, the fiber should be cleaned or replaced. The console will automatically detect this condition, put the laser in Standby mode, and display a message. The FiberLife feature will stop laser emission if the laser is accidentally fired while inside the cystoscope. Generally, this will prevent serious damage to the cystoscope. Some discoloration of the metal may still occur, which can increase the possibility of corrosion. 1.3 Vaporization The console uses photo-selective vaporization for the resection of soft tissue. The 532 nm green laser light emitted is strongly absorbed by oxyhemoglobin in red blood cells. Absorption of the laser light energy results in the generation of heat, which bursts cells, effectively vaporizing the targeted tissue. Additionally, the heat can coagulate blood vessels near the resected tissue, allowing for a clear surgical field. If bleeding occurs, the console also has a pulsed coagulation feature.

1.5 User Information Only persons trained in the use of the laser console and who have sufficient medical knowledge should use the GreenLight XPS Laser System. The user should have a demonstrated understanding of the laser console’s operation and the risk associated with improper use. 1.6 Contents • Laser Console • Footswitch • Fiber Pole • Key Chain • Laser In-Use Sign • Physician Protective Eyewear • Spectator Protective Eyewear 2 Intended use/Indications for use The GreenLight XPS Laser System is intended for the surgical incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Suggested applications include: • General Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue as well as in endoscopic (for example, laparoscopic) or open surgeries. 3

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1.4 Coagulation The console has a pulsed coagulation feature. In this mode, activated when the coagulation (coag) footswitch is pressed, laser emission is pulsed at a rate of ~12.5 Hz with a duty cycle of ~25 %. This pulse mode improves the coagulative effect.

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Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions); gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcers, colitis, hemorrhoids). • Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids. • Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. • Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type. • Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. • Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures. • Spinal Surgery: Percutaneous lumbar discectomy. • Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoracoscopic or open procedures. • Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of bladder, urethral and ureteral tumors; condylomata; lesions of external genitalia; urethral and penile hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from Benign Prostatic Hyperplasia (BPH). The GreenLight XPS™ Laser System is intended for the hospital, office, and outpatient surgery center markets.

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3 contraindications The laser system is contraindicated for patients with the following conditions: • General medical condition that contraindicates surgical intervention • When appropriate anesthesia is contraindicated by patient history • Calcified tissue (especially tumors) • Hemostasis of vessels over approximately two millimeters in diameter • When laser therapy is not considered the treatment of choice • Uncontrolled bleeding disorders and coagulopathy • Prostate cancer • Acute urinary tract infection (UTI) • Severe urethral stricture The GreenLight XPS Laser System is contraindicated in the presence of severe urethral strictures; however, the system can be used in the treatment of urethral strictures with proper cautions. A severe stricture shows visible narrowing on urethrography or ultrasonography, with near total obstruction that makes passage of instruments difficult or dangerous. Use caution to avoid injury to urethral tissue. 4 warnings • Everyone in the room is required to wear protective eyewear. • Never use a clamp to secure the laser fiber to a drape. The use of a clamp to secure a fiber may cause the fiber to bend at sharp angles, which can damage the fiber, causing an unsafe condition. The fiber can break and release laser energy, causing a burn in the protective jacket. If undetected, this condition will result in a burn or ignition of flammable materials. • Do not fire the laser unless the aiming beam is visible and directed at the targeted tissue. • Never activate the laser energy unless the fiber tip extends visibly beyond the tip of the endoscope. • Unauthorized use of internal controls, adjustments to the equipment, or performance of procedures other than those specified herein, may result in hazardous radiation exposure. • Warning signs are not interchangeable. Select a sign that is appropriate for the wavelengths in use. • When using anodized, black chrome finished, or ebonized instruments during a surgical procedure, additional care should be taken to prevent burns. These instruments will become extremely hot when they come in contact with a laser beam and are not able to dissipate heat quickly. When tissue is touched under these conditions, a burn may result. • Unauthorized modification of this equipment is not allowed. Do not attempt to repair or alter any components/parts of the GreenLight XPS Laser System. All repairs and servicing are to be performed only by Boston Scientific Corporation (BSC) or personnel authorized by BSC. 5 Precautions • Before operating the laser system, surgeons and all staff operating the laser should carefully read and become familiar with the User’s Manual. • Do not attempt to turn on the laser system until it has been installed and tested by a BSC service engineer. Severe damage to the laser system may result. • Alterations in surgical approach or technique may be required to accommodate laser use. • The laser system is a surgical device used by surgeons who have been trained in laser surgery through courses, preceptorships, or under the guidance of other surgeons knowledgeable in laser use. • The surgeon should become fully acquainted with the unique surgical effects produced with the laser system before clinical use. These effects include coagulation, depth of penetration, and cutting intensity. 4

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The risk of combustion, perforation, and laser-induced hemorrhage, all of which could cause serious or fatal complications, must be fully explained to the patient. As with non-laser treatments, adverse reactions such as fever, chills, sepsis, edema, and hemorrhage may occur after laser treatment. In extreme cases, death may occur due to procedural complications, concurrent illness, or the application of the laser. Caution should be taken when radiation therapy and laser therapy are to be used concurrently, including more stringent post-operative monitoring. Patients who have undergone radiation therapy may present a greater risk of perforation or tissue erosion. Use caution with patients who had previous esophageal/tracheal fistulae or episodes of aspiration. Use caution when treating patients who had difficulty with previous endoscopic/cystoscopic procedures. No claim is made that the laser system will cure the medical condition or eliminate the diseased entity. Repeated treatment or alternative therapies may be required. BSC has no clinical information or experience concerning the use of the laser system on pregnant women or nursing mothers. Before turning the laser system on, operating room personnel and the patient should be wearing protective eyewear suitable for the laser energy. A basin of water should be available in case a fire should occur. Do not press either footswitch while checking the aiming beam. To avoid damage from the treatment beam or its backscatter, it is recommended the fiber be fully visible in the visual field. Do not fire the laser unless the aiming beam is visible and directed at the intended target. Aim and use the laser only on tissues that are in full view. Avoid firing the laser if the fiber tip is in an air pocket. Do not bury the fiber in tissue. Do not use the fiber as a probe. Firing the working beam continuously at one location (not sweeping the beam) may result in difficult to control bleeding or perforation. If extended contact between the fiber tip and tissue is unavoidable, use the lowest power at which acceptable vaporization can be achieved, but no more than 80 W. If the working beam or aiming beam exits the fiber in an unusual direction, cease firing immediately, determine if there has been unintended tissue damage and take appropriate action. Replace the fiber before continuing with the procedure. The surgeon should carefully assess the target and surrounding tissue, and then begin at the lowest appropriate power, with short duration exposures. Do not adjust the power of the laser until the effect of the laser on the tissue has been evaluated. Note the surgical effect and adjust the settings and sweeping speed until the desired effect is obtained. Use of lower power levels and shorter exposure times are required to prevent thermal damage to underlying structures, for example, to thinwalled structures, such as the bladder. Tissue perforation can occur if excessive laser energy is applied. This can occur using excessive laser power or the application of power for excessive periods of time, particularly on diseased tissue. Examples of diseased tissue include tissue that has undergone brachytherapy, tissue that is infected, or tissue that has thinned due to another underlying disease other than BPH. Use caution when lasing tissue in close proximity to known arteries, nerves, and veins. Use caution to protect endotracheal tubes from laser radiation. Ignition or perforation of endotracheal tubes by the laser beam could result in serious or fatal patient complications. The laser may not be effective for coagulation in massive hemorrhage situations. The surgeon must be prepared to control hemorrhages with strident alternative non-laser techniques, such as ligature or electrocautery. The surgeon should schedule follow-up visits in the same manner as for patients undergoing such surgery with other modalities. Exercise care for special risks related to the disposal of the device. See End of Useful Life section. The laser system must be kept dry during storage and transport with temperatures between: • 32 °F to 104 °F (0 °C to 40 °C) with all water drained from system • 39 °F to 104 °F (4 °C to 40 °C) with cooling system charged with distilled or deionized water Improper storage or transport of the laser system may result in damage to the cooling system, optical resonator, and other critical components.

6 ADVERSE EVENTS Users should read and understand the specific indications, contraindications, warnings, precautions, and current adverse events included with the fiber used in conjunction with the GreenLight XPS™ Laser System. Potential adverse events associated with the GreenLight XPS Laser System are, but not limited to, the following: • Abdominal bloating (intestinal gas) • Acute renal failure • Allergic reaction • Aspiration • Bladder neck contracture • Bladder spasm • Bleeding • Burn • Chills • Clot retention

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Contamination of the device may lead to injury, illness, or death of the patient Deep venous thrombosis Delay in healing Dysuria Edema Embolism Epididymitis Erectile dysfunction (ED) Fatigue or weakness Fever Fluid overload/hyponatremia Gas over-distension Hematospermia Hematuria Infection Leukocytosis Malfunction of laser fiber or console resulting in an injury or prolonged procedure Nocturia Overactive bladder Pain: • Abdominal pain unresponsive to Nonsteroidal Anti-inflammatory Drugs (NSAIDs) • Arm or leg pain • Headache • Back/low back pain • Body aches • Pelvic • Penile Pelvic hematoma Penile urethral injury Perforation Pneumothorax Profuse perspiration (not fever-related) Prostatitis Pulmonary embolus Retrograde ejaculation Sepsis Stricture Tissue damage Tissue sloughing Ulceration Unretrieved device fragment Ureteral orifice injury Urethral stricture Urgency Urinary frequency Urinary incontinence Urinary retention Urinary tract infection

6.1 Some Adverse Events Further Explained Bleeding: Patients may experience bleeding at the site of the laser therapy during or after laser therapy. Post-treatment hemoglobin and hematocrit are recommended lab tests to assess the severity of bleeding. Fever and Leukocytosis: Immediately after laser therapy, the patient may experience fever and leukocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment. Cultures may be indicated to exclude the possibility of infection. Pain: Short-lived pain may occur immediately after endoscopic/cystoscopic laser therapy and may persist for 48 hours. 6

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6.2 Complications And Risks By Indication For all indications, see Intended Use/Indications for Use section. General Surgery Complications and Risks: See Adverse Events for general information. There is a potential risk of thermal damage at the site of the incision. For endoscopic/laparoscopic procedures, there are no known complications and risks specific to general surgery other than those associated with laparoscopy procedures in general (that is, over-distension, subcutaneous emphysema). See Contraindications for general information. There are no known contraindications specific to general surgery at this time. Endoscopic/ laparoscopic procedure patients should be treated with alternative methods when laparoscopy is contraindicated. Gastroenterology See Adverse Events for general information. The risk of combustion, perforation and laser-induced hemorrhage, all of which could cause serious or fatal complications, must be fully explained to the patients. Use caution when radiation therapy and laser therapy are to be used concurrently, including more stringent post-operative monitoring. Patients who have undergone radiation therapy may present a greater risk of perforation or tissue erosion. Use caution with patients who had previous esophageal/tracheal fistulae or episodes of aspiration. Discontinue laser therapy immediately if the patient develops cardiopulmonary problems. To avoid the potential risk of endoscope ignition or damage from the treatment beam or treatment beam backscatter, it is recommended that the fiber extend 1 to 2 cm beyond the distal port of the endoscope, so it is entirely in the visual field. After esophageal procedures, swallowing may be paradoxically worsened, rather than immediately improved. This is caused by secondary tissue edema. Explain this potential problem to the patient before therapy. See Contraindications for general information. There are no known contraindications specific to gastroenterological use at this time. Gynecology See Adverse Events for general information. There are no known complications and risks specific to gynecology at this time. See Contraindications for general information. These procedures may be contraindicated for women who are pregnant or have a suspected pregnancy, and for whom hysteroscopy or laparoscopy, or open abdominal surgery would not be appropriate. These procedures may be contraindicated for women with other medical or surgical conditions that would contraindicate laparoscopic or hysteroscopic surgery. Head and Neck/Otorhinolaryngology (ENT) See Adverse Events for general information. For cosmetic purposes, it is recommended that initial incisions be performed with conventional scalpels or that skin edges incised with the laser be cut back by approximately 0.5 mm to 1.0 mm with a scalpel before closing the skin. Use caution to protect the endotracheal tubes. Contact with the laser beam could result in serious or fatal patient complications. When using the laser for coagulation in ENT applications, it is essential to de-focus the laser beam spot to preclude tissue damage beyond the desired coagulation site. Unintended tissue damage could result from a focused treatment beam. While clinical experience to date has demonstrated that lasers can be safely used for hemostatic in ENT, there have been reports of serious complications when lasers are used inappropriately. The main risk of laser use is thermal damage to the surrounding vital structures, which is risky for oval window surgery as energy applied directly to the open oval window will pass directly through the perilymph and be absorbed by the inner ear structures. Other complications related to laser surgery include, but are not limited to burns, scarring, hemorrhage, perforations, fires and explosions, eye injury, electrical shock, swelling, and obstruction. Thermal damage caused by laser treatment has been related to adverse side effects and other risks. For example, where laser tissue welding is used, such as in laser-assisted myringoplasty, a low strength anastomosis or thermal damage to tissue are the main concerns. Delayed postoperative pain and slow healing are both thought to be related to thermal damage caused by the laser during tonsillectomy. Compared to traditional scalpel cutting surgery, laser treatment has sometimes resulted in slower healing in procedures such as uvulopalatoplasty and tonsillectomy. Tissue necrosis, post-operative edema, or bleeding was rarely seen. Slow healing increases the risk of infection. The presence of necrosis could leave the tonsillar bed more vulnerable to infection. See Contraindications for general information. There are no known contraindications unique to ENT. Neurosurgery Particular care must be exercised in heating the brain stem area. Flushing with cool saline in such areas will reduce heat build-up and related bradycardia. See Adverse Events for general information. There are no known specific complications and risks to neurosurgery use at this time. See Contraindications for general information. These procedures are contraindicated for the treatment of necrotic or calcified tumors. Ophthalmology See Adverse Events for general information. There are no known specific complications and risks to ophthalmology use at this time. See Contraindications for general information. These procedures are contraindicated for the treatment of necrotic or calcified tumors. 7

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Perforation: Perforation can occur as a result of excessive exposure to laser radiation. Perforation can occur from tumor erosion, or as a result of endoscopic/cystoscopic procedure. To clinically diagnose perforations, patients must be closely monitored post-operatively through physical assessment of clinical symptoms, hematology studies as deemed appropriate, and radiography. Sepsis: Laser-ablated tissue may become infected after therapy. If a question of sepsis exists, a culture should be taken and other appropriate evaluations made. As with conventional endoscopic treatments, adverse reactions such as fever, chills, sepsis, edema, and hemorrhage are possible after laser treatment. In extreme cases, death may occur due to procedural complications, concurrent illness, or the application of the laser. Use caution when treating patients who had difficulty with previous endoscopic procedures.

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Spinal Surgery See Adverse Events for general information. Some patients have reported an inflammatory response four to ten days post-operative at the site of surgery. This has occurred in patients who have reported a successful procedure post-operatively and are otherwise asymptomatic. The occurrence of this adverse event has reportedly been significantly reduced by the administration of an anti-inflammatory agent, into the surgical site, at the completion of the procedure. With surgical procedure in the spine, there is the potential risk of infection, inflammation and post-operative pain. The injection of antibiotics, anti-inflammatory drugs, and analgesics into the surgical area at the completion of the procedure has been reported to reduce the occurrence of these adverse events. See Contraindications for general information. General anesthesia is specifically contraindicated for this procedure. This procedure is contraindicated, if the following conditions exist: • Non-contained disc herniation (leakage of dye into epidural space by discogram) • Radiographic evidence of spinal stenosis > 50 % • Progressive neurological loss • Cauda Equina Syndrome • Tumor • Infection • Fracture • Spondylolisthesis • Spinal instability • Free fragments or other significant pathologies • Significant (> 30 %) narrowing of disc space, possible facet damage • Patients with previous surgery/chemonucleolysis at the indicated level may be a candidate for laser disc decompression. • All other factors should be considered. Plastic Surgery The laser is not intended for use for skin incision or liposuction. See Adverse Events for general information. Initial skin incision using the laser may result in undesirable scar formation. See Contraindications for general information. There are no known contraindications unique to plastic surgery. Thoracic Surgery The use of contact delivery devices (for example, sculptured fibers) on lung tissue, in conjunction with the wavelength, is considered investigational. When performing thoracoscopic surgery it is vital for the surgeon to appreciate that the view provided is monocular (not binocular) and that depth perception is decreased. Practice on the part of the surgeon to get the feel of operating through a monocular scope is strongly recommended before clinical use. In surgery of a body cavity that is insufflated, the surgeon and the anesthesiologist must appreciate the risk of embolism, should a blood vessel be opened. Most surgeons prefer CO2 as the pressurizing gas of choice, as it is readily absorbed and does not lead to embolism. The anesthesiologist should monitor the patient for unusually high CO2 absorption, and adjust procedures, as necessary. See Adverse Events for general information. There are no known specific complications and risks to thoracic surgery use at this time. See Contraindications for general information. There are no known contraindications unique to thoracic surgery. Urology See Adverse Events for general information. 7 How supplied Do not use if the package is opened or damaged. Do not use if labeling is incomplete or illegible. 7.1 Handling and Storage • Storage and transport temperature with all water drained from the system: 32 °F to 104 °F (0 °C to 40 °C) • Storage and transport temperature with cooling system charged with distilled or deionized water: 39 °F to 104 °F (4 °C to 40 °C) • Store in a dry place When in storage or transport outside of the recommended temperature ranges, damage may occur to the cooling system, optical resonator, and other critical components. The console should be drained using the field drain procedure. For complete draining procedure, contact BSC technical support. When the console is drained and in storage, the desiccant pack should be replaced on a six-month interval. 8 SAFETY 8.1 Eye Injury Visible light laser energy passes through the transparent components of the eye (cornea, lens, aqueous, and vitreous humor), and is focused on the retina. This light can cause an accidental retinal burn. The degree of injury to the eye will depend upon the power of the beam, how focused the beam is, and how long the eye is exposed to the beam. Protective eyewear for the operating room staff and patient should be provided. Laser eyewear may not be interchangeable between lasers of different wavelength, power, or divergence angle. 8

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WARNING: It is required for everyone in the room to wear protective eyewear. Eyewear has been designed to protect operating room personnel from the 532 nm laser energy. The eyewear has a minimum optical density (OD) of 6.0 at 532 nm. The eyewear requirements for EU are 532 D L6. These types of laser protective eyewear include: • Nearly clear physician laser protective eyewear - The essentially clear lens material has high visible light transmission and minimal color distortion. • Orange protective eyewear - Although it has good visible light transmission, the orange color of the plastic lens causes some color distortion. 8.2 Burns Personnel using lasers should be knowledgeable of the fire hazards associated with laser use. Accidental irradiation of tissue other than the target tissue may result in a burn or vaporization. Surrounding the target area with moist drapes or saline-soaked sponges will keep it moist and greatly reduce this hazard. Flammable or combustible items in the laser environment may include flammable liquids or combustible ointments, gases, plastics, paper or gauze materials, adhesive or plastic tapes, and endotracheal tubes. Laser appropriate fire extinguishers and water should be available where lasers are used. Care and precision in aiming and applying laser energy are important. WARNING: Never use a clamp to secure the laser fiber to a drape. The use of a clamp to secure a fiber may cause the fiber to bend at sharp angles and damage the fiber. To do so can result in an unsafe condition. The fiber can break and release laser energy causing a burn in the protective jacket. If undetected, this condition will result in a burn or ignition of flammable materials. 8.3 Reflection of the Beam From Instruments Use caution when aiming the laser beam to prevent reflection of the beam off metallic surgical instruments. Mirror-finish instruments are especially dangerous as they have highly reflective surfaces. The laser light reflected from such instruments is intense and potentially harmful. Matte, dull, satin-finished, or ebonized instruments have fewer glares, and those with curved surfaces do not reflect light as intensely. While these instruments usually produce a more diffused reflection that is less harmful, this reflection can still be damaging. Protective eyewear should be worn at all times to prevent eye damage. WARNING: When using anodized, black chrome finished, or ebonized instruments during a surgical procedure, additional caution should be taken to prevent burns. These instruments will become extremely hot when they come in contact with a laser beam and are not able to quickly dissipate heat. When tissue is touched under these conditions, a burn may result. 8.4 Ignition of Flammable Materials The laser can ignite many materials used during a surgical procedure. Use of non-flammable materials is strongly recommended.

8.6 Operating Room Environment This section describes specific safety measures for the operating room to aid in the safe operation of the laser system. Medical Electrical Equipment (MEE) is not intended to be used in an oxygen-rich environment. Laser Warning Signs The area where the laser system is operated should be labeled. Warning signs that specify the laser wavelength being used should be posted at all operating room and access door entrances. Figure 1 is an example of a sign suitable for use with the laser system.

Figure 1. Laser Warning Sign 9

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8.5 Electrical Electrical hazards with the laser are the same with any electrical device. Use caution when plugging the unit into the wall outlet. The area must be free of water and user’s hands must be dry. Always disconnect the laser by grasping the plug and not the power cord. Examine the electrical cord routinely, if signs of wear are noted, contact BSC technical support to have it repaired or replaced.

Remote Door Interlock Always limit personnel in the operating room to those essential to the procedure. To protect intruding personnel from exposure to the laser beam, an optional remote door interlock can be connected from the console to the operating room entrance door. This interlock will automatically put the console in Standby mode if the door is opened during a procedure. The console will remain in Standby mode until the door is closed and the interlock is reset. Once reset, the user can place the console back in Ready mode and reactivate the surgical beam. The console cannot be placed in Ready mode, unless the interlock is reset. If the use of the remote door interlock is desired, the biomedical personnel at the user’s facility can connect it. The user should test the remote interlock before each use. Access to the console’s interlock function is made through a socket located on the back panel of the console (see Figure 3). Safety Recommendations The following are general safety recommendations for the operating room and are not specific to the laser system: • When using accessories, tools, disposables, or materials that were in contact with the patient, take protective measures to prevent cross-contamination. • Keep drapes and towels moist to prevent their ignition and burning. • Use non-flammable prepping solutions. • Prevent combustion of methane gas by packing the rectum during perineal procedures. • Do not use the laser in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. WARNING: Do not fire the laser unless the aiming beam is visible and directed at the targeted tissue. 8.7 Safety Features of the Laser System The GreenLight XPS™ Laser System incorporates the following safety features: • The laser will stop firing when the pressure is removed from either footswitch pedal. • An automatic circuit breaker shuts the console off in the event of an electrical overload. • The laser provides an operating room door interlock connection, which must be set up by the biomedical personnel. • The key can only be removed when the key-switch is in the OFF position. • An onboard microprocessor continuously monitors the status of the console and displays messages on the screen along with appropriate user prompts. • Laser energy cannot be emitted from the console unless a fiber has been connected. • Console will go into ready mode when the Ready button is touched on the touchscreen, or when the button on top of the footswitch is pressed. • A fiber pole lifts and positions the fiber in a safe and unobtrusive position. • A continuous audible tone is heard when the surgical beam is activated (that is, foot pedal is pressed). A higher frequency tone is heard for vaporization and a lower tone for coagulation. • When the laser is fired for the first time after entering Ready mode, and whenever switching between vaporization mode and coagulation mode, a voice will annunciate the current mode. • A 2-second delay occurs before laser energy is emitted after the laser is placed in Ready mode. • An Emergency Laser Stop switch is available to disable the console immediately, in the case of an emergency. • When switching between Ready and Standby mode, a voice will announce the current mode.

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Note: Do not attempt to remove any panel from the console. All panels are fitted with tamper-proof fastenings. Any attempt to remove the panels, unless instructed by authorized BSC personnel, can damage the console and will void the manufacturer’s warranty. Note: The laser system should be protected against unauthorized use. When the console is not in use, remove the key from the key switch and place in a secure location. WARNING: Unauthorized use of internal controls, adjustments to the equipment, or performance of procedures other than those specified herein, may result in hazardous radiation exposure. WARNING: No modification of this equipment is allowed. Tipping Hazard:

During transportation, pull or push the console carefully using the intended handle to prevent tipping. WARNING: Console may tip if inclined at an angle of greater than 5 degrees. Rolling Hazard: Secure the console with the wheel locks to prevent the unit from inadvertently rolling. 10

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9 CONSOLE description

1. Screen/Touchscreen 2. Card Reader

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4. Fiber Shield 6. Fiber Port Cover 7. Emergency Laser Stop 8. On/Off Key Switch

9. Footswitch

Figure 2. Front View of Console

2. 3. 4. 5. 6. 7. 8. 9.

Screen/Touchscreen - Displays user information: • Console status (Standby, Ready) • Laser output (in watts), separate display for vaporization and coagulation • Aiming beam brightness level • Energy meter (displays total number of Joules delivered) • Exposure time (displays total time light is emitted) • Buttons on the screen, when pressed, place the laser in either Ready or Standby mode • Error codes and screen prompts Card Reader - Reads fiber card Storage Compartment Fiber Shield - Protects the fiber hub from inadvertent damage Fiber Pole - Secures and protects the fiber (retractable) Fiber Port Cover - Connection for fiber Emergency Laser Stop - Turns console off and terminates laser light emission in case of emergency On/Off Key Switch - Switches the console on and off Footswitch - For control of laser emission

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1.

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1. Back Handle 2. Upper Power Cord Storage Hook 3. Footswitch Storage Hook

4. Footswitch Cord Storage Hook

5. Footswitch Connection 6. Service Port 7. Remote Interlock Socket 8. Coolant Reservoir

9. Coolant Drain

11. Lower Power Cord Storage Hook 12. Circuit Breaker

10. AC Power Cord

13. Wheel Lock

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

Figure 3. Back View of Console 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

Back Handle Upper Power Cord Storage Hook - 2 upper hooks for coiling footswitch cord Footswitch Storage Hook - 2 hooks for footswitch storage Footswitch Cord Storage Hook - 2 hooks for coiling footswitch cord Footswitch Connection Service Port - USB ports for factory service only Remote Interlock Socket - Can be connected to the room door so the footswitch will be disabled in the event of entry Coolant Reservoir - For refilling the internal cooling liquid (see Coolant Refill Instructions) Coolant Drain - For draining the internal cooling liquid (see Coolant Refill Instructions) AC Power Cord Lower Power Cord Storage Hook - 2 lower hooks for coiling power cord Circuit Breaker - Automatically trips in the event of a power overload, shutting off power to the console Wheel Lock - For locking and unlocking back wheels

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10 ACCESSORIES The operator must use accessories/tools that were cleared by BSC for use with the laser system. BSC assumes no liability and warranty for damage and consequential damage when using the laser system with non-qualified accessories/tools. Contact BSC for an up-to-date list of accessories/ tools for the GreenLight XPS™ Laser System. 10.1 Video Camera Insert A video camera insert must be inserted between the telescope and the camera (unless a comparable camera insert is built into the telescope). The video camera inserts have an optical density (OD) of 5 at a wavelength of 532 nm. This blocks most of the laser light, preventing saturation of the video camera sensor. The optimum transmission at wavelengths other than 532 nm and the video camera insert diameter depends on the video camera and telescope model. 10.2 Laser Protective Eyewear Eyewear has been designed to protect operating room personnel from the 532 nm laser energy. The eyewear has a minimum optical density (OD) of 6.0 at 532 nm. The eyewear requirements for EU are 532 D L6. • Physician protective eyewear - The essentially clear lens material has high visible light transmission and minimal color distortion. • Spectator protective eyewear - Although it has good visible light transmission, the orange color of the plastic lens causes some color distortion. 11 Installation This section provides general guidelines for the installation of the laser system. This laser system has specific installation requirements. It is the user’s responsibility to fulfill these requirements before the installation of the laser system. Improper installation can result in intermittent operation and even damage to the laser system. Please read the below information carefully. 11.1 Responsibility of BSC A BSC service representative will install the laser system. Upon arrival at the installation site, the representative will perform the following: 1. Verify appropriate electrical power is available. 2. Remove the console from the crate and inspect for damage. 3. Perform all optical, electronic, and system checks necessary to bring the laser into operation. 4. Inventory all shipped accessories. 11.2 Responsibility of Customer Provisions for proper power must be made before the receipt and installation of the laser system. Return visits by service personnel for installation will not be covered under warranty. The customer should complete the Installation Checklist and return it to BSC or distributor. Upon completion of the pre-installation site preparation, contact BSC or the distributor to check shipment date and schedule installation of the system. The laser system uses standard electrical service and has built-in cooling systems; therefore, installation requires minimal site preparation.

11.4 Power Requirements The power source for the GreenLight XPS Laser System must be a single-phase service with voltage between 200 to 240 VAC, 50/60 Hz, current ≤ 20 Amp*. The laser will automatically adjust to the voltage and frequency within this range. The laser can function when some voltage change is present in the service line; however, the voltage may not vary by more than ± 10 %. For BSC to provide the correct electrical plug, the customer must provide information about the installed receptacle in the facility to BSC before installation. Any 250 VAC, current ≤ 20 Amp*, two poles, three wire receptacle can be used if it meets the system’s electrical requirements; meets facility, city, county, state, and country ordinances; and complies with EN 60601 for leakage current. It is recommended the GreenLight XPS Laser System use a dedicated circuit breaker with a minimum rating of 16 Amp or higher to ensure normal operation.

* The 20 Amp rating indicates the current rating that the power source is expected to be capable of supplying to operate the laser at the maximum rated power output of 180 W. The 20 A rating is neither the minimum nor maximum operational main current requirement; it is a current in which internal circuitry protects the GreenLight XPS Laser System in an over-current condition.

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Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

11.3 Positioning of the Console The console must be positioned not more than 5 ft (1.5 m) from the centerline of the treatment table to ensure proper handling of the fiber. Position the console at least 1 ft (0.3 m) from the wall for proper ventilation during use.

12 INSTRUCTIONS FOR USE 12.1 Touchscreen and Footswitch The touchscreen and footswitch are used to control the console. Laser parameters are selected and the console status is changed by using a touchscreen. Use the button on top of the footswitch to go between Ready and Standby laser status. The aiming beam is activated when the console is in the Ready mode or the surgical beam is activated. The surgical beam is activated by pressing a foot pedal. Press the yellow pedal for VAPOR and the blue pedal for COAG. Power is set by touching the

or

buttons on the touchscreen. An audible tone will be heard when the buttons are pressed.

Vaporization Power Indicator

Coagulation Power Indicator

Power Adjust Buttons

Power Adjust Buttons

Ready/Standby Control and Indicators

Reset Engery and Lasing Time

Engery Indicator

Changes to the Set-up Screen

Lasing Time Indicator

Figure 4. Touchscreen

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

Ready/Standby Button

Vapor Pedal

Coag Pedal

Figure 5. Footswitch 12.2 Preparation 1. Ensure protective eyewear is worn by all personnel including the patient. 2. Ensure the circuit breaker on the back of the console is OFF and connect the power cord to an appropriate electrical outlet. 3. Turn the circuit breaker to ON. On the front of the console, turn the key switch to ON. 4. The console’s self-check mechanism detects most problems. A message will appear on the touchscreen to alert the user of problems. Courtesy messages alert the user of problems that the user can correct. Service prompts alert the user of a problem that requires a service call. 14

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Note: It may take time (typically 5 to 15 minutes, but can be up to 40 minutes in rare cases such as extremely cold conditions) for the console to reach the proper operating temperature and pass all internal self-check tests before it is ready for operation. 5.

The console will perform self-tests. When the tests are completed, a screen is displayed prompting to insert fiber card.

6. 7.

Prepare the patient for the procedure. If the telescope does not include a built-in video camera insert, place a small or large video camera insert between the telescope and the camera. The video camera insert protects the camera from the high-intensity light. A. To insert the large video camera insert, hold the camera head pointing up. Place the video camera insert (labeled side facing towards camera) onto the camera head and depress the coupler. Attach the telescope to the camera. B. To insert the small video camera insert, hold the telescope portion of the cystoscope with the eyepiece pointing up. Place the video camera insert (writing side facing outward) into the eyepiece. Attach the camera to the telescope. Note: Some telescopes have a built-in video camera insert to prevent the transmission of green light. In this case, do not insert an additional video camera insert between the telescope and the camera.

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

CAUTION: Do not touch multiple areas on the touchscreen at one time. Contact in multiple areas of the screen will result in no response from the command buttons. Only touch the desired command button when making adjustments to parameters.

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8.

Open the laser fiber box. Locate the fiber card attached to the outside of the pouch. Insert the fiber card into the card reader with the chip side facing operator. The touchscreen then prompts for fiber attachment. Caution: Do not remove the fiber card until procedure is complete.

9.

Open the fiber pouch and remove the sterile fiber using aseptic technique. Note: To protect the laser-fiber interface, the fiber connector must be kept free of lubricant, cleaners, and other contaminants.

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

10. Connect the fiber to the fiber port of the console by pushing the connector into the fiber port (arrow on connector facing up) and turning it ¼-turn clockwise until it locks. 11. Follow additional instructions from the fiber package insert. 12. On the console, select the desired vaporization and coagulation setting by pressing the arrow keys.

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13. To change the aiming beam intensity, display intensity, or audio volume, touch Press for Set-up at the bottom of the main screen.

12.3 Procedure 17. Advance the assembled cystoscope with the visual obturator through the urethra into the bladder using standard technique. 18. Advance the fiber through the fiber port and into the visual field of view. A suction tube can be connected to the outflow port of the cystoscope to direct outflow irrigation. 19. Rotate the control knob of the fiber to examine the fiber markings. The triangle is contralateral to where the laser beams fires. The triangle must be visible at all times while firing the beam. The red octagonal stop sign is aligned with the aiming beam of the fiber. Do not activate the working beam if the stop sign is centered in the field of view. 20. Advance the fiber to the treatment site. The tip of the fiber should be in clear view and extended beyond the tip of the cystoscope. The output beam of the fiber is aligned with index of the knob on the distal portion of the fiber. 21. Place the console in Ready mode to enable the footswitch. 22. Observe that the aiming beam is on the tissue targeted for treatment before activating the laser.

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Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

14. Adjust the desired setting by touching the arrow keys. 15. To return to the main screen, touch Press for Main Menu at the bottom of the screen. 16. Press the Ready button to activate the aiming beam. When the Ready button turns orange, the laser system is ready for use in a procedure.

23. Laser energy will be emitted when a footswitch is pressed. The Active mode (Vaporization Active or Coagulation Active) is displayed at the top of the screen, depending on the footswitch pressed. Audio tone sounds during emission. The first time a given footswitch is pressed, the word Vapor or Coag will be vocalized, depending on which footswitch is pressed.

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

24. To go back to Standby, press Standby or step on the black Ready/Standby footswitch. 25. The laser emission can be disabled and the aiming beam can be turned off by pressing the Standby button on the touchscreen or by stepping on the black Ready/Standby footswitch. 26. Begin the procedure. Treatment times may vary based on tissue, power settings, and other factors. 27. Steadily rotate (sweep) the laser beam across a 30 ° to 40 ° arc over the targeted tissue, continually moving the laser beam while maintaining a working distance (fiber-to-tissue distance) between 1 mm and 3 mm. Adjust the sweep speed to achieve the desired tissue effect. Adjusting the power level will affect the rate of tissue removal. 28. Bleeding can often be controlled by sweeping the working beam around (not directly at) the bleeder while pressing the Coag footswitch. In Coag mode the beam is modulated to increase coagulation effectiveness. This causes the beam to pulse (blink on and off). Adjust the sweep speed and Coag power to achieve the most effective coagulation. Do not fire the laser directly at the center of the source of the bleeding. 29. Once the desired tissue has been treated, turn off the inflow and outflow valves of the cystoscope, and check for bleeding. If bleeding is occurring, it may be necessary to treat the bleeding. 30. Once the laser treatment has ended, fill the bladder with saline, and remove the cystoscope. Slowly drain the bladder and check the flow and color of the outgoing fluid. The placement of a Foley catheter may be necessary at physician discretion. 31. Prescribe post-procedure medication at physician discretion. 12.4 After the Procedure 32. When the procedure has ended, place the console in Standby mode. 33. Document the total lasing time and energy appropriately. 34. Remove the fiber from the cystoscope and discard per hospital procedures. Remove the cystoscope from the patient. 35. Remove the fiber card and discard. 36. Turn the key switch to the OFF position. 37. On the back panel, switch the circuit breaker to the OFF position and disconnect the AC power cable from the electric outlet. 38. To protect against unauthorized use, remove the key from the key switch and store in a secure location. 39. The footswitch can be stored on the back of the console. 40. Store the laser system per recommendations in Handling and Storage.

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13 TECHNICAL DATA Table 1. Console Specifications Laser Type

Solid-state, frequency doubled

Wavelength

532 nm

Maximum Power Output at 532 nm

Limited by fiber delivery device, up to 180 W

Nominal Ocular Hazard Distance (NOHD)

67.1 meters (MPE = 10 W/m2)

Repetition Rate

Vaporization: Quasi-CW (23.6 kHz) Coagulation: Modulated at ~12.5 Hz, ~25 % duty cycle

Maximum Aiming Beam Power

5 mW

Output Beam Divergence

≥ 0.078 Radians

Electrical Requirements

200 to 240 VAC, 50/60 Hz, ≤ 20 Amp, single-phase

Operating Temperature

50 °F to 86 °F (10 °C to 30 °C)

Operating Humidity

10 % to 90 %, non-condensing

Dimensions

Width: Approximately 22 in (56 cm) Depth: Approximately 36 in (91 cm) Height (screen down): Approximately 48 in (122 cm) Height (screen up): Approximately 55 in (140 cm)

Weight

Approximately 475 lb (215 kg)

AC Power Cable

15 ft (457 cm) maximum length, model 321203 AC power cable is a trademark of OLFLEX.

Footswitch Cable

13 ft (396 cm) maximum length, Cordset #997-G27-1 Footswitch cable is a trademark of LINEMASTER Switch Corporation.

Standards and Regulations

• •

Safety Regulations conforms with EN/IEC 60825 EMF output conforms with IEC 60601-1 General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

13.1 Safety Classifications and Electromagnetic Compatibility Classification: Type of protection against electric shock: Class I equipment Table 2. Electromagnetic Emissions Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF Emissions CISPR 11

Group 1

The GreenLight XPS Laser System uses RF energy only for its internal function. Therefore, its RF emissions are low and are not likely to cause interference in nearby electronic equipment.

RF Emissions CISPR 11

Class A

Harmonic Emissions IEC 61000-3-2

Class A

The GreenLight XPS Laser System is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage Fluctuations/Flicker Emissions IEC 61000-3-3

Section 5 of Standard

WARNING: This equipment/system are intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the GreenLight XPS Laser System or shielding the location.

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The GreenLight XPS™ Laser System is intended for use in the electromagnetic environment specified below. The customer or user of the GreenLight XPS Laser System should assure that it is used in such an environment.

Table 3. Electromagnetic Interference Resistance Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The GreenLight XPS™ Laser System is intended for use in the electromagnetic environment specified below. The customer or user of the GreenLight XPS Laser System should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical Fast Transient/Burst IEC 61000-4-4

± 2 kV for power supply lines

± 2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV line to line ± 1 kV line(s) to line(s) ±2 kV line(s) to ground ±2 kV line(s) to ground

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5 % UT (> 95 % dip in UT for 0.5 cycle)

< 5 % UT (> 95 % dip in UT for 0.5 cycle)

40 % UT (60 % dip in UT for 5 cycles)

40 % UT (60 % dip in UT for 5 cycles)

70 % UT (30 % dip in UT for 25 cycles)

70 % UT (30 % dip in UT for 25 cycles) < 5 % UT

< 5 % UT (> 95 % dip in UT for 5 sec) Power Frequency (50/60 Hz) N/A Magnetic Field IEC 61000-4-8

N/A

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans

Mains power quality should be that of a typical commercial or hospital environment. If the user of the GreenLight XPS Laser System requires continued operation during power mains interruptions, it is recommended that the GreenLight XPS Laser System be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the AC mains voltage prior to application of the test level.

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Mains power quality should be that of a typical commercial or hospital environment.