Table of Contents
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Table of ConTenTs
1 deviCe desCripTion ......................................................................................................................................................................................................................3
1.1 Console .....................................................................................................................................................................................................................................3
1.2 FiberLife ....................................................................................................................................................................................................................................3
1.3 Vaporization .............................................................................................................................................................................................................................3
1.4 Coagulation ..............................................................................................................................................................................................................................3
1.5 User Information .....................................................................................................................................................................................................................3
1.6 Contents....................................................................................................................................................................................................................................3
2 inTended use/indiCaTions for use .......................................................................................................................................................................................3
3 ConTraindiCaTions ......................................................................................................................................................................................................................4
4 warnings .........................................................................................................................................................................................................................................4
5 preCauTions....................................................................................................................................................................................................................................4
6 adverse evenTs .............................................................................................................................................................................................................................5
6.1 Some Adverse Events Further Explained ............................................................................................................................................................................6
6.2 Complications And Risks By Indication ..............................................................................................................................................................................7
7 How supplied..................................................................................................................................................................................................................................8
7.1 Handling and Storage.............................................................................................................................................................................................................8
8 safeTY ................................................................................................................................................................................................................................................8
8.1 Eye Injury ..................................................................................................................................................................................................................................8
8.2 Burns .........................................................................................................................................................................................................................................9
8.3 Reflection of the Beam From Instruments ..........................................................................................................................................................................9
8.4 Ignition of Flammable Materials ...........................................................................................................................................................................................9
8.5 Electrical...................................................................................................................................................................................................................................9
8.6 Operating Room Environment ...............................................................................................................................................................................................9
8.7 Safety Features of the Laser System .................................................................................................................................................................................10
9 Console desCripTion ................................................................................................................................................................................................................11
10 aCCessories ................................................................................................................................................................................................................................13
10.1 Video Camera Insert ..........................................................................................................................................................................................................13
10.2 Laser Protective Eyewear .................................................................................................................................................................................................13
11 insTallaTion ...............................................................................................................................................................................................................................13
11.1 Responsibility of BSC .........................................................................................................................................................................................................13
11.2 Responsibility of Customer ................................................................................................................................................................................................13
11.3 Positioning of the Console .................................................................................................................................................................................................13
11.4 Power Requirements ..........................................................................................................................................................................................................13
12 insTruCTions for use .............................................................................................................................................................................................................14
12.1 Touchscreen and Footswitch ............................................................................................................................................................................................14
12.2 Preparation ..........................................................................................................................................................................................................................14
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Black (K) ∆E ≤5.0
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Table of Contents
Summary of Contents for Greenlight XPS
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Page 1: Table Of Contents
Table of ConTenTs 1 deviCe desCripTion ............................................3 1.1 Console ..............................................3 1.2 FiberLife ..............................................3 1.3 Vaporization .............................................3 1.4 Coagulation ..............................................3 1.5 User Information .............................................3 1.6 Contents..............................................3 2 inTended use/indiCaTions for use .......................................3 3 ConTraindiCaTions ............................................4 4 warnings .................................................4 5 preCauTions..............................................4 6 adverse evenTs .............................................5 6.1 Some Adverse Events Further Explained ....................................6 6.2 Complications And Risks By Indication ....................................7 7 How supplied..............................................8... - Page 2 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...
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Page 3: Device Description
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. -
Page 4: Contraindications
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. -
Page 5: 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: •... -
Page 6: Some Adverse Events Further Explained
• 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: •... -
Page 7: Complications And Risks By Indication
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. -
Page 8: How Supplied
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. -
Page 9: Burns
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. -
Page 10: Safety Features Of 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. -
Page 11: Console Description
9 Console desCripTion 1. Screen/Touchscreen 2. Card Reader 3. Storage Compartment 5. Fiber Pole 4. Fiber Shield 6. Fiber Port Cover 7. Emergency Laser Stop 8. On/Off Key Switch 9. Footswitch figure 2. front view of Console Screen/Touchscreen — Displays user information: • Console status (Standby, Ready) •... - Page 12 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.
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Page 13: Accessories
* 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. -
Page 14: Instructions For 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. - Page 15 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. The console will perform self-tests.
- Page 16 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. 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.
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Page 17: Procedure
13. To change the aiming beam intensity, display intensity, or audio volume, touch Press for Set-up at the bottom of the main screen. 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. -
Page 18: After The 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. -
Page 19: Technical Data
Manufacturer’s declaration — electromagnetic emissions 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. - Page 20 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.
- Page 21 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.
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Page 22: Maintenance
Manufacturer’s declaration — electromagnetic immunity The GreenLight XPS™ Laser System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the GreenLight XPS Laser System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the GreenLight XPS Laser System as recommended below, according to the maximum output power of the communications equipment. -
Page 23: End Of Useful Life
Remove and then re-insert card Invalid Fiber Card The fiber attached is not a valid GreenLight XPS™ Laser System device. The part 10-2079 not valid for this system number of the invalid fiber is displayed. Replace the fiber with one approved for use with GreenLight XPS Laser System. -
Page 24: Service Prompts
An error code will appear in a yellow box on the screen. When these error codes appear, the user should accurately record the complete problem number and contact BSC technical support or call the local GreenLight XPS™ Laser System distributor. -
Page 25: Warranty
Every mobile provider must have suitable transportation for moving the GreenLight XPS Laser System from site to site. The vehicle must have a lift gate or ramp, depending on the height of the vehicle, to load and unload the GreenLight XPS Laser System. - Page 26 Catalog Number Legal Manufacturer CAUTION. Attention: Consult Serial Number Fabricante legal Número de catálogo ACCOMPANYING DOCUMENTS. Número de serie Fabricant légal Numéro de catalogue PRECAUCIÓN. Atención: consulte los Numéro de série Berechtigter Hersteller Bestell-Nr. DOCUMENTOS ADJUNTOS. Seriennummer Fabbricante legale Numero di catalogo AVERTISSEMENT.
- Page 27 Separate Collection Keep Dry Australian Sponsor Address Turkey Local Contact Recogida independiente Dirección del patrocinador australiano Contacto local en Turquía Mantener seco Élimination séparée Tenir au sec Adresse du promoteur australien Contact local en Turquie Sonderabfall Adresse des australischen Sponsors Lokaler Kontakt Türkei Trocken halten Raccolta differenziata...
- Page 28 Laser Emergency Stop Button Temperature limitation. Draining Laser Warning Botón de parada de emergencia del láser Límite de temperatura. Drenaje Advertencia sobre el láser Bouton d'arrêt d'urgence du laser Limite de température Purge Mise en garde relative au laser Laser-Notstopptaste Temperaturbegrenzung Entleeren Laser-Warnhinweis...
- Page 29 Service Port USB Connection This product complies with standards set forth in EN 60601-1, 60601-1-2 Conexión USB de puerto de servicio and 60601-2-22. cTUVus Mark indicates compliance to UL 60601-1 and Connexion USB du port de maintenance CAN/CSA 22.2 601.1 M90 covering electrical safety requirements for the Service-Port USB-Anschluss US and Canada.
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