Greenlight XPS Service Manual Rev A

Service Manual

Copyright © 2009 American Medical Systems. All rights reserved. Part No. 0010-0240 Rev A Printed in U.S.A.

Notice No part of this manual may be reproduced or transmitted in any form or by any means without the written consent of AMS™. The information in this manual is subject to change without notice.

Disclaimer AMS provides this document in its commitment to help facilitate consistent, positive clinical outcomes, and to reduce patient risk and injury. These guidelines are not, however, intended to in any way replace or substitute a physician’s duty of care, professional responsibility, or professional judgment, nor are they intended to provide any warranty, promise, guarantee, assumption of risk or duty, release, or indemnity. Physicians shall at all times maintain responsibility for patient treatment and outcomes, and AMS further assumes no liability for patient treatment or outcome or for physician’s negligence, breach of duty of care, or malpractice. In no way does this or any of AMS’ policies, procedures, training materials, guidelines, or instructions create an obligation for AMS to perform any services. Products and services may be purchased from AMS.

Trademarks GreenLight XPS™ Laser System is an AMS Research Corp. trademark

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Preface Conventions NOTE: Points out additional information that may be helpful.

 CAUTION: Alerts you to situations that could result in instrument damage, failure in a procedure, or incorrect results.

 WARNING: Alerts you to situations that could result in bodily harm or irreparable damage to the equipment.

Who Should Read This Manual? All users of the GreenLight XPS system should read this manual thoroughly before attempting any repair. Pay particular attention to all warnings, contraindications, and precautions noted in this manual and other related materials. Failure to do so may result in harm to a patient or the user of the system.  CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Obtaining Help 1. Read through the section of the guide specific to the operation you are performing. Refer to the table of contents to locate information. 2. See Section 8: Troubleshooting for a list of problems and suggested solutions. 3. For additional information covering installation, medical applications, or any other questions, contact the Customer Care Center at: •

(800) 356-7600 from inside the US, or +1 (408) 456-3585 from outside the US.

•

Or contact your local distributor from the list at the beginning of this manual

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Table of Contents

Preface PREFACES READER AUDIENCE

Section One

ii ii

Safety

HAZARDS AND PRECAUTIONS SERVICE PRECAUTIONS Eye Injury Burns Reflection Ignition of Flammable Materials Electrical OPERATING ROOM ENVIRONMENT

1-1 1-1 1-2 1-2 1-2 1-2 1-2

Laser Warning Signs Remote Door Interlock SAFETY FEATURES Safety Regulations Console Labeling COMMON QUESTIONS ADDITIONAL HAZARDS Components of a Safe Laser Program Electrical Hazards Skin Hazards DOCUMENTATION

1-3 1-4 1-7 1-7 1-8 1-10 1-11 1-11 1-11 1-11 1-11

Section Two

System Specifications

SPECIFICATIONS SPACE REQUIREMENTS Positioning the Laser Console ELECTRICAL REQUIREMENTS ENVIRONMENTAL REQUIREMENTS

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Table of Contents

Section Three Installation/Transportation/De-Installation SYSTEM INSTALLATION 3-1 Unpacking the System 3-1 Condition of Laser and Container 3-1 Remote Interlock 3-1 ADDING WATER 3-1 Adding internal Water 3-1 ELECTRICAL SERVICE REQUIREMENTS 3-2 VERIFICATION of SYSTEM OPERATION AND POWER MEASUREMENTS 3-2 DE-INSTALLATION OF SYSTEM 3-3 TRANSPORTATION OF SYSTEM 3-3

Section Four

Cooling

COOLING SYSTEM Solenoid Water Valve Water to air heat exchanger INTERNAL WATER COOLING Description Fill and Drain Ports Fan Pump and Motor COMPONENT REPLACEMENT

Section Five

4-1 4-1 4-1 4-1 4-1 4-1 4-2 4-2

Electronic Components

SYSTEM PC BOARD DESCRIPTIONS Fiber Port FiberLife Resonator Control Touch Screen Controller Laser Power Supply Master Control Power Distribution COMPONENT REPLACEMENT

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Table of Contents

Power Distribution Board 24 Volt Power Supply Rear Panel Board RF Driver System Data Log Board FUSE REPLACENMENT

Section Six

5-2 5-3 5-3 5-3 5-3 5-4

Resonator

RESONATOR PEPLACEMNT Removing the existing Resonator Installation of new Resonator

6-1 6-1 6-1

Section Seven Preventive Maintenance COMPONENTS PM PROCEDURE

Section Eight

Troubleshooting

COURTESY MESSAGES COMMON FAULT MESSAGES

Section Nine

7-1 7-1

8-1 8-4

Appendix

BLOCK DIAGRAM DRAIN PROCEDURE

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Section 1 Safety 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.

 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. These types of laser protective eyewear include:



Nearly clear Physician Laser Glasses. The essentially clear lens material has very high visible light transmission and minimal color distortion.



Orange Eye Protection Glasses. Although it has good visible light transmission, the orange color of the plastic lens causes some color distortion.

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 utilized. Care and precision in aiming and applying laser energy is of paramount importance.

 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.

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Section 1 Safety Reflection of the Beam from Instruments Care should be taken 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 very harmful. Matte, dull, satin-finished, or ebonized instruments have less glare, 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 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 quickly dissipate heat. When any tissue is touched under these conditions, a burn may result.

Ignition of Flammable Materials The laser can ignite many materials used during a surgical procedure. Use of non-flammable materials is strongly recommended.

Electrical Electrical hazards with the laser are the same as with any electrical device. Care should be taken when plugging the unit into the wall outlet. The area must be free of water and your 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 AMS to have it repaired or replaced.

Operating Room Environment This section describes specific safety measures for the operating room to aid in the safe operation of the Laser System.

Laser Warning Signs The area where the laser is operated should be clearly labeled. Warning signs that specify the laser wavelength being used should be posted at all operating room and access-door entrances. Figure 3-1 is an example of a sign suitable for use with the Laser System.

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Section 1 Safety Laser System Warning Sign

AMS REORDER NO. 0010-0241

LASER RADIATION

– AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION - CLASS 4 LASER PRODUCT- TO EN60825-1:2007

LASERSTRAHLUNG

– AUGEN- ODER HAUTKONTAKT MIT DIREKTER ODER GESTREUTER STRAHLUNG VERMEIDEN - KLASSE-4-LASERPRODUKT- TO EN60825-1:2007

LASER IN USE

Laser in Betrieb RAYONNEMENT AU LASER – ÉVITER TOUTE EXPOSITION DES YEUX OU DE LA PEAU AU RAYONNEMENT DIRECT OU DISPERSÉ - PRODUIT LASER DE CLASSE 4- TO EN60825-1:2007

Laser en cours d'utilisation RADIACIÓN LÁSER

– EVITE LA EXPOSICIÓN DE OJOS O PIEL A LA RADIACIÓN DIRECTA O DISPERSA - PRODUCTO LÁSER CLASE 4- TO EN60825-1:2007

Láser en uso RADIAZIONE LASER

– EVITARE L’ESPOSIZIONE DEGLI OCCHI O DELLA PELLE ALLA RADIAZIONE DIRETTA O DISPERSA - PRODOTTO LASER CLASSE 4- TO EN60825-1:2007

Laser in Funzione RADIAÇÃO LASER

– EVITAR EXPOSIÇÃO DOS OLHOS E DA PELE À RADIAÇÃO DIRETA OU REFLETIDA - PRODUTO LASER CLASSE 4- TO EN60825-1:2007

Laser em uso

635±10nm 5mW MAX. CW

532nm 180W MAX. CW

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Section 1 Safety 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 Laser System to the operating room entrance door. This interlock will automatically put the laser in STANDBY if the door is opened during a procedure. The laser will remain in STANDBY until the door is closed and the interlock is reset. Once reset, the operator can place the system back in READY and reactivate the surgical beam. The laser cannot be placed in READY 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 prior to each use. Access to the laser unit’s interlock function is made via a socket located on the back panel of the laser (see Figure 1-2 Rear View of the Laser System).

Safety Recommendations The following are general safety recommendations for the operating room and are not specific to the Laser System:    

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 aim beam is clearly visible and directed at the targeted tissue.

Safety Features of the laser system Safety Regulations The United States Code of Federal Regulations, CFR Title 21, Ch. 1, Sections 1040.10, and 1040.11, EN 60825 and EN 60601-2-22 require that lasers have certain safety features. These regulations and standards further require that labels be affixed to each laser unit identifying the manufacturer, the class or classes of radiation produced, and the location of the laser aperture(s) on the unit. The safety features of the Laser System are described in the following list. All required labeling information is also provided in this section. 1.1.1.1.1.1 SYSTEM SAFETY FEATURES The GreenLight XPS Laser System incorporates the following safety features: 

The laser will stop firing when the pressure is removed from either footswitch.



An automatic circuit breaker shuts the system completely off in the event of an electrical overload.



The laser provides an operating room door interlock connection, which must be set up by the hospital personnel.

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Section 1 Safety 

The key can only be removed when the keyswitch is in the OFF position.



An on-board microprocessor continuously monitors the status of the system, and displays messages on the video screen along with appropriate operator prompts.



Laser energy cannot be emitted from the system unless a fiber has been connected.



Laser will go into ready when the READY button is touched, or when the button on top of the footswitch is pressed.



A fiber support pole elevates and positions the fiber in a safe and unobtrusive position.



A continuous audible tone is heard when the surgical beam is activated (i.e., 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 status.



An Emergency Laser Stop switch is available to disable the system immediately, in the case of an emergency situation



When switching between READY and STANDBY, a voice will announce the current mode.



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 AMS personnel, can damage the laser and will void the manufacturer’s warranty.

IMPORTANT NOTE:

Laser equipment should be protected against unauthorized use. When the laser 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.

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Section 1 Safety Console Labeling Figures 3-2 and 3-3 show the location of all labels on the laser unit. The actual labels used in these locations are also shown.

Figure 3-2

Emergency Off (International)

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Section 1 Safety Certification Label

Laser Warning Logo

Service, Foot Pedal, Remote Interlock, Fill Label

Power Cord Grounding Label

Circuit Breaker

Figure 3-3: Labeling of Rear Panel of Laser System

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Section 2 System Specifications CONSOLE SPECIFICATIONS Laser Type

Solid State, Frequency Doubled

Wavelength

532 nm

Maximum Power output at 532 nm

Limited by fiber delivery device, maximum 180W

Nominal Optical Hazard Distance (NOHD)

33.9 meters (MPE = 110-3 W/cm2)

Repetition rate Maximum Aiming Beam power Output Beam Divergence

Vaporization: Quasi-CW (15kHz – 22kHz) Coagulation: Modulated at 12Hz, 25% duty cycle 5mW Perpendicular to fiber: 0.49±0.09, Parallel to fiber: 0.25±0.06 radians full angle at half minimum with the 10-2090 fiber in air

Electrical Requirements

200-240 VAC @ 60 Hz or 50 Hz, 20 A, Single phase

Operating Temperature

50 F (10 C)  85 F (30 C)

Storage/Transport Temperature

50 F (10 C)  104 F (40 C)

Humidity

10% - 90%, non-condensing Width: less than 22 inches

Dimensions

Depth: less than 36 inches Height: less than 58 inches

Weight

Less than 475 pounds

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Section 2 System Specifications

ELECTRICAL REQUIREMENTS The power source for the GreenLight™ XPS Laser System: Voltage: Current: Phase:

200-240 VAC @50/60 Hz 30 amps Single (two wire with ground)

A 250 VAC, 30 Amp, 2 pole, 3 wire plug that is acceptable for portable medical equipment of this current rating is recommended. However, Any 250 VAC, 20 Amp or higher, two pole, three wire receptacle can be used as long as it meets the system’s electrical requirements; meets facility, city, county, state, and country ordinances; and complies with EN 60601 for leakage current. The laser can function when some voltage change is present in the service line, however the voltage may not vary by more than ± 10%. Recommended receptacle and plug: Receptacle: Nema Configuration: L6-30R. The plug sent with the machine is the Hubbell twist lock plug: HBL2621 AMS PN 2120-0028.

Note All units are equipped with an internal multi-tap isolation transformer allowing the laser to automatically reconfigure its internal operating voltages. ENVIRONMENTAL REQUIREMENTS The recommended temperature range for the room where the laser will be operated is 50 F (10 C)  85 F (30 C)

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Section 3 Installation / De-Installation / Transportation Installation GreenLight™ XPS Laser System

 WARNING:

It is the Policy of AMS that Installation be performed by AMS trained personnel.

Unpacking the GreenLight™ XPS Laser System Disconnect the metal clips along the edge of the crate using a screw driver. Remove the front panel of the box off the base. This becomes your ramp. Remove the foam bars on the ramp. Make sure the wooden notch on the ramp is connected over the top of the wooden notch located at the front bottom of the crate. Slowly guide down the ramp. Note the Condition of shipping container and foam-set. Check the "TIP AND TELL". If tripped, proceed with the installation. After installation call AMS Customer Support at (800) 356-7600 so that the information can be documented. Remote Interlock Connect the remote interlock to the back of the laser (see system overview diagram). The laser will not allow user interface without the remote interlock connected, the laser will display "Remote Interlock Open". Make sure this is connected before turning the system on. Add Water to the Cooling System

 CAUTION:

Do not turn the laser on without De-ionized or Distilled water in the laser.

Add Internal Water Use only de-ionized or distilled water. With the system turned off, pour water in to the fill container until no more water is accepted. Do not overfill. Turn the system on and add more water if necessary. If the system shuts off, it is due to the low water pressure in the water pump. Turn the key OFF and repeat the above steps. Please contact AMS customer Care at (800) 3567600 for any other errors displayed.

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Section 3 Installation / De-Installation / Transportation Electrical Requirements Prior to installation verify the Electrical Service Requirements. Plug the AC power cord into the laser power receptacle and into the power outlet. Check Packing lists, Accessories, and any back ordered items. If any discrepancies are found please contact AMS Customer Care at (800) 356-7600. Verification of System Operations and Power Measurements Make sure the remote interlock and footswitch are connected. Start the system by turning on the key switch, located on the front of the laser. Let the laser complete its warm-up cycle. Laser light presents a severe eye hazard and a potential to burn tissue or ignite materials. Never activate the system treatment beam without eye protection. All personnel working with a laser should be aware of these hazards and take the necessary precautions to prevent them. Safety glasses must be worn for the following power checks. Attach a 600 micron fiber (flat cut). Direct the distal end of fiber into an AMS approved, calibrated power meter. Measure actual power displayed vs. power delivered per the following chart in applications mode. This chart is for reference only:

Power Displayed

Acceptable Range

20 Watts

19 - 23 watts

40 Watts 60 Watts 80 Watts

38 - 45 Watts 58 - 68 Watts 78 - 91 watts

100 Watts

98 - 113 Watts

120 Watts 140 Watts 160 Watts 180 Watts

119 - 136 Watts 139 - 158 Watts 159 - 181 Watts 179 - 198 Watts

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Section 3 Installation / De-Installation / Transportation De-Installation GreenLight™ XPS Laser System Refer to Technical Bulletin #93 in the appendix for the draining procedure. Transportation GreenLight™ XPS Laser System The XPS crate (0133-4430) should always be used for transportation of the XPS system. The XPS system should never be transported with internal water. Refere to DeInstallation section. Remove the front panel of the crate, this becomes your ramp. Remove the foam bars on the ramp. Make sure the wooden notch on the ramp is connected over the top of the wooden notch located at the front bottom of the crate. Slowly guide the system up the ramp. Secure the safety strap. Connect the metal clips along the edge of the crate using a mallet. The weight of the laser system is less than 477 pounds (215 kg) and suitable transportation devices are required as well as the use of a Tail Lift Truck and/or Pallet Truck.

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Section 4 Cooling System GREENLIGHT HPS COOLING SYSTEM

COOLING SYSTEM 

Solenoid Valve The solenoid valve is internal to the chiller and it serves to maintain the proper resistivity of the chiller’s DI water. It will open as needed to allow return water to flow through a resin, de-ionizing filter cartridge to keep the cooling water’s resistivity between 0.2 and 0.3 megaohm-cm.



Valve/Flow Switch The Valve/Flow Switch assembly is used to set the diode stack’s nominal flow rate. The flow rate setting is referenced on a label on the side of the resonator. The Valve/Flow switch assembly protects the diode from damage caused when the water flow rate to the diode is below a preset level. When the flow switch is open, the diode power supply interlock is opened preventing power to the diode stacks.



Water to Air Heat Exchanger The water to air heat exchanger (HX) is internal to the chiller. It is actually two separate heat exchangers that move heat from the laser’s cooling water to refrigerant (R134A) and from the refrigerant to the ambient air.

INTERNAL WATER COOLING Description The cooling system holds roughly 1700ml of water, de-ionized or distilled only. It is important to maintain approximately 1.5 feet clearance around the laser, especially for the airflow from the front to the rear of the laser, to avoid overheating. The cooling system is monitored for temperature and water flow. Water is added to the cooling system through the fill port and into the reservoir. It then travels from the reservoir to the water pump. The pump cycles the water to the resonator to cool the diode, YAG Rod and Q-Switch. The water circulates through the diode power supply, into the resonator and exits the resonator through the water outlet fitting. The water then goes through the chiller for cooling and D.I. polishing (as needed). Air is pulled via a fan through the air-to-water heat exchanger to cool the D.I. water. Fill and Drain Ports: The fill and drain port is used to fill and drain the laser’s internal cooling system. Fan: The fan speed is constant and controlled by the chiller.

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Section 4 Cooling System Pump and Motor: The pump is rated at a maximum flow rate of 2.5 GPM. If the pump is run dry, damage to the pump will occur. The pump is energized when the key switch is turned to the ON position. COMPONENT REPLACEMENT  WARNING: Complete all electronic component replacements with the system key switch and breaker in the OFF position, and the laser unplugged. Remove:  Open right and left side panel doors.  Disconnect LPS interlock cable.  Drain laser by disconnecting the two chiller lines. Have a receptacle available to catch the drained water.  Drain reservoir at back of system by connecting drain hose, Have a receptacle available to catch the drained water.  Remove drain fitting at bottom left side on the back of the laser and push through back panel.  Using a screw driver or ball driver, press button on quick disconnect fitting behind reservoir to release reservoir from fitting and set aside.  Unscrew cap and disconnect overflow hose. Set aside.  At right side of laser, feed overflow hose back through for chiller clearance.  Loosen flat head screw on right side of connector J700.  On the left side of the laser, disconnect the chiller power connector.  Remove two screws at bottom of chiller.  Have the Replacement Component available for the next steps  Remove top cover from the shipper crate of the replacement chiller. The shipper crate top cover will be used to store the defective chiller.  Slide existing chiller out of the chassis onto the shipper crate top cover. Install:  Position the replacement chiller while still in the bottom portion of the shipper crate next to the laser in preparation to slide it into the chassis.  Slide in the replacement chiller making sure the chiller is straight and snug against the foam located at front of laser.  Reconnect drain fittings to the back of the system before securing the screws at the bottom of the chiller.  Disconnect interlock cable to diode power supply.  Connect the flow meter to the flow gauge.  Place the knob on the flow valve.  ADD WATER  Turn the system on.  Verify the chiller set point in Service Mode.

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