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Laserscope GreenLight HPS Operator's Manual

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Laser Operator's Manual
Manufactured by
3070 Orchard Drive
San Jose, CA 95134
(800) 356-7600
+1 (408) 943-0636

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Summary of Contents for Laserscope GreenLight HPS

  • Page 1 Laser Operator’s Manual Manufactured by 3070 Orchard Drive San Jose, CA 95134 (800) 356-7600 +1 (408) 943-0636...
  • Page 3 In no way does this or any of Laserscope’s policies, procedures, training materials, guidelines, or instructions create an obligation for Laserscope to perform any services. Products and services may be purchased from Laserscope.

  • Page 5: Table Of Contents

    Ignition of Flammable Materials ............ xiv Vapor/Smoke Plume ..............xiv Electrical..................xiv Operating Room Environment ............xv Reference Sources ..............xvii ™ Safety Features of the GreenLight HPS ........xviii Safety Classifications ..............xix Labeling ..................xxi Section 1: Introduction ..............1 System Overview ..............1 GreenLight HPS Fiber Optic.............
  • Page 6 General Post-Procedural Instructions ..........43 List of Figures ™ Figure S-1 GreenLight HPS Laser Warning Sign ........xv Figure S-2 Labeling of Front Panel of Laser ........xxi Figure S-3 Labeling of Rear Panel of Laser ........xxii Figure 1-1 Front View of Laser ............2 Figure 1-2 Rear View of Laser ............

  • Page 7: Preface

    Section 2: System Installation provides the physical and • ™ environmental requirements necessary to operate the GreenLight HPS laser system, as well as information on how to move the instrument should you need to. Section 3: Operating the System gives you step-by-step instructions on how •...

  • Page 8: Conventions

    2. See Section 6: Troubleshooting for a list of problems and suggested solutions. 3. For additional information covering installation, medical applications, or any other questions, contact Laserscope Customer Response Center at: (800) 356-7600 from inside the US, or • Outside the US, contact your local distributor.

  • Page 9: Safety

    (2) this device must accept any interference received, including interference that may cause undesired operation. CAUTION: Changes or modifications not expressly approved by Laserscope could void the user's authority to operate this equipment. EYE INJURY RECOMMENDED PRACTICE V: ALL PEOPLE IN THE NOMINAL HAZARD ZONE SHOULD WEAR APPROPRIATE EYEWEAR APPROVED BY THE LASER SAFETY OFFICER.
  • Page 10 Laser Protective Eyewear ™ There are several products available for use with the GreenLight HPS laser system to protect both eyes and video equipment. This section describes the laser protective eyewear and the video camera filters that have been designed to meet ANSI Z136.3-1996, ANSI Z136.1-2000 and DIN standards...
  • Page 11 Two different types of eyewear have been designed to protect operating ™ room personnel from the GreenLight HPS laser energy. These include: • The Surgeon Glasses (catalog number 10-1350 and 10-0008). They have a min. optical density (OD) of 5.0 at both 532. The essentially clear lens material has very high visible light transmission and minimal color distortion.
  • Page 12 3. Does my eyewear protect me if I can see green light during lasing? Laserscope eyewear is designed to block out a specific portion of the light spectrum in green, and allow other parts of the spectrum to pass through.
  • Page 13 Exposure time in excess of damage threshold With proper use of the laser equipment, the chance of these events occurring simultaneously is remote, but may occur. Laserscope supports the ANSI recommendation that all personnel in the operating room wear appropriate eyewear when the laser is being used for open or endoscopic procedures.
  • Page 14 8. Where can I find additional information about eye safety and protection? Current literature on laser applications is available in medical libraries. Additional information on terms, definitions and reference materials may be obtained by reviewing ANSI Z136.1-1986 and ANSI Z136.1-2000 and ANSI Z136.3-1996, or by contacting: •...

  • Page 15: Burns

    BURNS RECOMMENDED PRACTICE VIII: ALL PERSONNEL IN THE LASER TREATMENT AREA SHOULD BE PROTECTED FROM FLAMMABILITY HAZARDS ASSOCIATED WITH LASER USE. 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, regardless of the wavelength.

  • Page 16: Ignition Of Flammable Materials

    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 the Laserscope Customer Response Center at (800) 356-7600 to have it repaired or replaced. When performing a surgical procedure that requires large amounts of irrigation, protect the foot pedal in a plastic bag.

  • Page 17: Operating Room Environment

    Figure S-1 is an example of a ™ sign suitable for use with the GreenLight HPS laser system. WARNING: Warning signs are not interchangeable. Select a sign that is appropriate for the wavelengths in use.
  • Page 18 (see Section 1.1. System Overview). Safety Recommendations The following are general safety recommendations for the operating room and are not specific to the GreenLight HPS System: • Keep drapes and towels moist to prevent their ignition and burning. •...

  • Page 19: Reference Sources

    REFERENCE SOURCES Reference material and additional information regarding laser safety may be obtained from the following sources: ANSI Z136.3 The Safe Use of Lasers in Health Care Facilities American National Standards Institute, (ANSI), 1988. AORN: Standards, Recommended Practices and Guidelines. 2006 Laser Safety in the Practice edition: Recommended Practices for Settings.

  • Page 20: Safety Features Of The Greenlight Hps

    ™ The safety features of Laserscope’s GreenLight HPS laser system are described in the following sections. All required labeling information is also provided in these sections.

  • Page 21: Safety Classifications

    IMPORTANT NOTE: Do not attempt to remove any panel from the laser console. All panels are fitted with tamper-proof fastenings. Any attempt to remove the panels, unless instructed by authorized Laserscope personnel, can damage the laser and will void the manufacturer’s warranty.
  • Page 22 This equipment has been tested and found to comply with the limits for medical devices to the IEC 601-1-2:1994. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.

  • Page 23: Labeling

    LABELING This figure shows the location of all labels on the laser unit. The actual labels used in these locations are also shown. LASER APERTURE AT END OF DELIVERY DEVICE Attention: Consult Accompanying Documentation (International) Emergency Off (International) Figure S-2 Labeling of Front Panel of Laser Safety...

  • Page 24: Figure S-3 Labeling Of Rear Panel Of Laser

    FOOT REMOTE PEDAL INTERLOCK -CAUTION- -CAUTION- SAFETY AND COOLING SYSTEM PROTECTION FILL SAFETY AND COOLING SYSTEM PROTECTION FILL COOLING SYSTEM WITH COOLING SYSTEM WITH 100% D.I. OR DISTILLED 100% D.I. WATER ONLY WATER ONLY Figure S-3 Labeling of Rear Panel of Laser xxii Operator’s Manual...

  • Page 25: Section 1: Introduction

    Nd:YAG solid state laser. The laser system delivers a visible 532nm laser light with a power setting range of 20 to 120W, in 10W increments. The GreenLight HPS laser system features a “Plug and Play” capability that self-adjusts to the facility’s individual voltage requirements, eliminating the need for electrical modifications.

  • Page 26: Figure 1-1 Front View Of Laser

    Display/Touch screen Card reader Data Port Storage Compartment Fiber Shield Fiber pole Fiber Optic Port Emergency Laser Stop Button ON/OFF Key Switch Figure 1-1 Front View of Laser Operator’s Manual...
  • Page 27 Front View of Laser (1) Display / Touch Screen - Displays operator information: • System status (Standby, Ready) • Laser output (in Watts). Separate display for vaporization and coagulation. • Lights up when surgical beam is fired and indicates vaporization or coagulation •...

  • Page 28: Figure 1-2 Rear View Of Laser

    Rear Storage (10) Rear Handle Product ID Label (11) Footswitch Upper Footswitch Connection Cord Storage Hook Footswitch (12) Remote Storage Hook Interlock Socket Lower Footswitch Cord Storage Hook Upper Power Cord Storage Hook Coolant Reservoir (Fill) (13) Electrical Connection Coolant Drain (14) Circuit Breaker...
  • Page 29 Rear View of Laser Rear Storage Product ID Label Upper Footswitch Cord Storage Hook – 2 upper hooks for coiling footswitch cord Footswitch Storage Hook – 2 hooks for footswitch storage Lower Footswitch Cord Storage Hook – 2 lower hooks for coiling footswitch cord Upper Power Cord Storage Hook –...

  • Page 30: Greenlight Hps Fiber Optic

    30º forward oblique telescope, and visual obturator. The GreenLight HPS fiber is used to cut, coagulate and vaporize tissue in endoscopic and open surgical procedures at a 70º forward defection angle to the fiber axis. It can rotate 360-degrees, allowing tissue access in multiple planes;...

  • Page 31: General Instructions For Use

    5. Check for kinks or bright areas along the entire length of the GreenLight HPS fiber. Do not use the fiber if it has been damaged. 6. Once the GreenLight HPS fiber has been checked, return the laser to the STANDBY mode.

  • Page 32: Sterilization

    1.4 STERILIZATION Laserscope recommends that GreenLight HPS fibers be used in only one surgical procedure. The GreenLight HPS fiber is a sterile, single-use, disposable device and should not be re-used or re-sterilized. After the completion of the procedure, dispose of the GreenLight HPS fiber following the standard hospital protocol for bio-hazardous material.

  • Page 33: Section 2: System Installation

    CAUTION: The crated system should be stored in a protected area in temperatures between 50°F (10°C) and 104°F (40°C). Laserscope’s Responsibility A Laserscope Service Representative will install the laser system. Upon arrival at the installation site, the representative will perform the following: 1. Verify appropriate power.

  • Page 34: Space And Power Requirements

    The laser can function when some voltage change is present in the service line, however the voltage may not vary by more than ± 10%. In order for Laserscope to provide the correct electrical plug, the customer must provide information about the installed receptacle in the facility to the Customer Service Department prior to installation.

  • Page 35: Section 3: Operating The System

    3.1 THE TOUCH SCREEN AND FOOTSWITCH This section describes the touch screen and footswitch used to control the ™ GreenLight HPS laser system, and provides step-by-step instructions on how to operate the system. Laser parameters are selected and the system status is changed by using a touch screen.

  • Page 36: Turning The System On

    THE FOOTSWITCH Ready/standby button Coag pedal Vapor pedal 3.2 TURNING THE SYSTEM ON The following procedure is recommended for system start-up: 1. Confirm the system circuit breaker is in the OFF position to prevent a power surge to the system. 2.
  • Page 37 5. The system will go through a series of self-tests. When the tests are completed, the following screen will be displayed: 6. Located inside of each fiber box attached to the sterile fiber pouch is a fiber card. Insert the card into the card reader. The screen will then prompt you to attach the fiber.
  • Page 38 7. Attach the fiber. Connect the fiber optic by pushing the connector into the fiber optic port (arrow on connector facing up) and turning it ¼-turn clockwise until it locks. The following screen will appear: 8. To select the treatment parameters, adjust the power by touching –...
  • Page 39 11. The main screen will re-appear: 12. To change the system’s settings, touch press for Set Up at the bottom of the main screen. The following screen will appear: 13. Adjust the desired setting by touching the – indicators. Press MAIN MENU to get back to the main screen. Operating the System...

  • Page 40: Operating Procedure

    3.3 OPERATING PROCEDURE 14. Press the READY button to activate the red aiming beam and set up the laser for emission. READY will change to orange. 15. The system is now ready for use in a procedure. Laser energy will be emitted when the footswitch is pressed.
  • Page 41 NEW fiber card and fiber optic must be inserted. The GreenLight HPS fiber can be used up to the energy limit printed on the seal of the fiber package. The user is alerted by an audible tone and a screen message when less then 50,000 joules remain.
  • Page 42 The following sequence of alerts will appear: 1. An audible tone will alert the user when 50,000 joules of usage remain on the fiber. The remaining energy will be displayed on the screen. 2. The following message will appear on the screen when the user lifts the foot off the pedal for the first time after less then 50,000 joules remain: Operator’s Manual...
  • Page 43 3. Press the screen as indicated to continue. The main screen will appear. Joules and lasing time remaining will be displayed. 4. To get the laser into Ready Mode, press the Ready/Standby button. 5. The following message will appear when the energy limit has been reached: To continue a procedure when the energy limit has been reached, a new fiber card and fiber optic must be inserted.

  • Page 44: Turning The System Off

    3.4 TURNING THE SYSTEM OFF After the completion of the procedure, please follow the shut down instructions as follows: 1. Record the Joule Meter total and lasing time, if desired. 2. Disconnect the fiber and discard in accordance to hospital policy for biohazard waste.

  • Page 45: Section 4: Physician Information

    Physician Information 4.1 TRAINING REQUIREMENTS ™ The GreenLight HPS laser system should be used only by practitioners who have been trained in its proper use. All users and support staff must have thorough knowledge of its operation and its effects. Users should familiarize themselves with this operator’s manual and with this device in a non-clinical...

  • Page 46: Potential Complications And Risks

    No claim is made that the laser will cure any medical condition. ™ • No claim is made that the GreenLight HPS laser system will cure any medical condition, or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may be required.
  • Page 47 532nm laser energy. • Laserscope has no clinical information or experience concerning the use of Laserscope’s laser systems on pregnant women or nursing mothers. • 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.
  • Page 48 • strident alternative non-laser techniques, such as ligature or electrocautery. • Alterations in surgical approach or technique may be required to accommodate laser use. • The surgeon should schedule follow-up visits in the same manner as for any patient undergoing such surgery with other modalities. •...

  • Page 49: Section 5: Maintenance

    NEVER pour water or any other liquid over the console. If any liquid is spilled on the console and it is thought that some may have gone inside, TURN THE UNIT OFF and call the Laserscope Customer Response Center. 5.2 COOLANT REFILL INSTRUCTIONS ™...

  • Page 50: Preventive Maintenance Schedule

    6. Replace cap. 7. Continue with laser start up. If a “water low” message is still present, call Laserscope Customer Service at (800) 356-7600 from inside the US or +1 (408) 943-0636 from outside the US; or call your local Laserscope distributor.

  • Page 51: Section 6: Troubleshooting

    Chapter 6 Troubleshooting Introduction The GreenLight HPS™ laser system’s self-check mechanism will alert operating room staff if there is a mechanical or software problem. A message will appear on the screen at the time of system malfunction. Depending on the...

  • Page 52: Service Prompts

    6.2 SERVICE PROMPTS An Error Code will appear and replace the main display. When these error codes appear, the operator should note the problem number and contact Laserscope Customer Service at (800) 356-7600 or call your local Laserscope distributor. NOTE:...

  • Page 53: Specifications

    Specifications Product specifications Laser Type Solid State, Frequency Doubled Wavelength 532 nm Average Power Levels 20-120 Watts in 10 Watt increments Aiming Beam Diode laser, red, 635 nm, <5mW adjustable Output Beam Divergence 0.05 - 0.15 radians full angle at half minimum Electrical Requirements 200-240 VAC @ 60 Hz or 50 Hz, 30 A...

  • Page 55: Warranty

    Laserscope service facility designated by Laserscope. Products may only be returned with the prior approval of Laserscope. A valid Return Material Authorization Parts Request (PR) number must evidence such approval. Buyer shall prepay shipping charges (and shall pay all duties and taxes) for products returned to Laserscope.
  • Page 56 3. Operation outside of the environmental specifications for the product. 4. Improper site preparation and maintenance, including but not limited to improper electrical utilities. 5. Use of delivery devices or accessories not manufactured by Laserscope or approved by Laserscope for use with Laserscope Systems. Additional Terms, Mobile Systems Warranty ™...

  • Page 57: Table W-1 Warranty Codes

    FOR DIRECT, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, (INCLUDING LOSS OF PROFITS) WHETHER BASED ON CONTRACT, TORT OR OTHER LEGAL THEORY. Warranty Codes Table W-1 summarizes the warranty codes assigned to Laserscope products, and lists the warranty period for each code. Warranty Code Warranty Commencement...

  • Page 58: Table W-2 Product Warranties

    NOTE: The products listed under Warranty Code 1 in Table 2 are examples only. This list is not inclusive. Warranty Products Covered Notes Code ™ GreenLight HPS Parts & Labor laser system for 12 months from Installation not to exceed 15 months from...

  • Page 59: Product Returns

    Please refer to this insert for answers to questions on return and repair policies and procedures for end-users of Laserscope accessories. All returns are handled by the Laserscope Customer Response Center at (800) 356-7600 or (408) 943-0636. After hours response will be handled on a call back basis.
  • Page 60 Operator’s Manual...

  • Page 61: Support Materials

    Support Materials To help you and your staff organize the operation and management related to the GreenLight HPS™ laser system, Laserscope has developed a package of practice assistance documents Listed below are the forms that are included in this chapter. For printing and customizing purposes, the forms are also included on the CD supplied with this manual.
  • Page 62 Warr...

  • Page 63: Clinical Competency Validation Checklist

    Criteria Met Comments and Date Completed basic training course highlighting laser safety and physics specific to the GreenLight HPS™ laser system and procedures performed in the facility. Prepares surgical suite for laser use: • Covers all windows with opaque covering (placed on inside of window) •...
  • Page 64 • Removes unneeded footswitches from the vicinity of the laser footswitch, preventing possible surgeon confusion and inadvertent firing of the laser. • Demonstrates use of “READY/STANDBY” button on touch screen and footpedal • Knows how to adjust laser power settings Knowledge/assistance during procedure •...

  • Page 65: Supplies Needed

    • GreenLight HPS™ Surgical Laser System • GreenLight HPS™ fiber card (supplied in fiber package) • Laserscope video camera insert marked O.D. 5 at 532 nm (diam. 1.25'' [Part No. 10-0721] or diam. 0.95'' [Part No. 10-0722] dependent on video camera and telescope model).

  • Page 67: Laser Log

    Laser Log Date: OR # Patient Surgeon Anesthesiolgist Pre Op Dx Anesthesia General Spinal: Post Op Dx Pudendal Block IV Sedation Procedure Laser s/n Prostate Gland Size: Fiber lot # 10-2090 Fiber lot # 10-2090 Circulating Nurse Fiber lot # 10-2090 If more than one fiber used, please note joules expended per fiber under comments section...

  • Page 70: Operative Record Template

    A preliminary cystoscopic examination was performed during which the ureteral orifices, bladder neck and verumontanum were identified. The GreenLight HPS™ laser was set at ___watts. The GreenLight HPS BPH™ laser fiber was introduced through the working channel of the cystoscope. The median lobe was identified and it was vaporized down to capsular fibers.

  • Page 72: Pre-Procedural Patient Instructions

    Coumadin® or Plavix®. Your doctor may recommend that you stop taking these medicines several days prior to the GreenLight HPS™ procedure. 3. Take any antibiotics as prescribed by your doctor. 4. Ask your doctor to write prescriptions for any medications he thinks you should take before the day of your scheduled procedure.

  • Page 74: General Post-Procedural Instructions

    PRACTICE NAME HERE GENERAL POST-PROCEDURAL INSTRUCTIONS You may need to wear a catheter to drain your bladder after the procedure, depending upon how much swelling your doctor thinks may occur immediately following the PVP procedure. This catheter is generally removed within 24 hours. Do not drive or operate dangerous equipment for 24 hours following anesthesia.

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