AMS GreenLight XPS Bedienungsanleitung

Service Manual

P/N 0010-0667, Rev A

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

Preface

P/N 0010-0067, Rev A

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,

+1 (408) 456-3585 from outside the US.

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

Table of Contents

P/N 0010-0667, Rev A

Preface

PREFACES ii

READER AUDIENCE ii

Section One Safety

HAZARDS AND PRECAUTIONS

SERVICE PRECAUTIONS 1-1

EyeInjury 1-1

Burns 1-2

Reflection 1-2

Ignition of Flammable Materials 1-2

Electrical 1-2

OPERATING ROOM ENVIRONMENT 1-2

Laser Warning Signs 1-3

Remote Door Interlock 1-4

SAFETY FEATURES 1-7

Safety Regulations 1-7

Console Labeling 1-8

COMMONQUESTIONS 1-10

ADDITIONALHAZARDS 1-11

Components of a Safe Laser Program 1-11

ElectricalHazards 1-11

SkinHazards 1-11

DOCUMENTATION 1-11

Section Two System Specifications

SPECIFICATIONS 2-1

SPACE REQUIREMENTS 2-1

Positioning the Laser Console 2-1

ELECTRICAL REQUIREMENTS 2-2

ENVIRONMENTAL REQUIREMENTS 2-2

Table of Contents

P/N 0010-0667, Rev A

Section Three Installation/Transportation/De-Installation

SYSTEM INSTALLATION 3-1

Unpacking the System 3-1

Condition of Laser and Container 3-1

RemoteInterlock 3-1

ADDINGWATER 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 4-1

Solenoid Water Valve 4-1

Water to air heat exchanger

INTERNAL WATER COOLING 4-1

Description 4-1

Fill and Drain Ports 4-1

Fan 4-1

Pump and Motor 4-2

COMPONENT REPLACEMENT 4-2

Section Five Electronic Components

SYSTEM PC BOARD DESCRIPTIONS 5-1

FiberPort 5-1

FiberLife 5-1

Resonator Control 5-1

Touch Screen Controller 5-1

Laser Power Supply 5-2

MasterControl 5-2

Power Distribution 5-2

COMPONENT REPLACEMENT 5-2

Table of Contents

P/N 0010-0667, Rev A

Power Distribution Board 5-2

24 Volt Power Supply 5-3

Rear Panel Board 5-3

RFDriver 5-3

System Data Log Board 5-3

FUSEREPLACENMENT 5-4

Section Six Resonator

RESONATOR PEPLACEMNT 6-1

Removing the existing Resonator 6-1

Installation of new Resonator 6-1

Section Seven Preventive Maintenance

COMPONENTS 7-1

PMPROCEDURE 7-1

Section Eight Troubleshooting

COURTESY MESSAGES 8-1

COMMON FAULT MESSAGES 8-4

Section Nine Appendix

BLOCKDIAGRAM 9-1

DRAINPROCEDURE 9-2

Section 1 Safety

P/N 0010-0067, Rev A

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.

Section 1 Safety

P/N 0010-0067, Rev A

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.

Section 1 Safety

P/N 0010-0067, Rev A

Laser System Warning Sign

AMS REORDER NO. 0010-0241

LASER RADIATION – AVOIDEYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION

- CLASS 4 LASER PRODUCT-TO EN60825-1:2007

LASER IN USE

LASERSTRAHLUNG – AUGEN- ODER HAUTKONTAKT MIT DIREKTER ODER GESTREUTER STRAHLUNG VERMEIDEN

- KLASSE-4-LASERPRODUKT- TO EN60825-1:2007

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

Section 1 Safety

P/N 0010-0067, Rev A

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.

1.1.1.1.1.1SYSTEM 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.

Inhaltsverzeichnis

Andere AMS Medizinische Geräte Handbücher

AMS

AMS 800 Bedienungsanleitung

AMS

AMS 700 LGX Bedienungsanleitung

Beliebte Medizinische Geräte Handbücher anderer Marken

TekTone

TekTone Tek-CARE160 Bedienungsanleitung

NeuroMetrix

NeuroMetrix Quell 2.0 Bedienungsanleitung

AMT

AMT XLR8 Bedienungsanleitung

EDAN

EDAN SONOTRAX Pro Bedienungsanleitung

Restorative Therapies

Restorative Therapies RT300 Bedienungsanleitung

Gendex

Gendex Expert DC Bedienungsanleitung

Dexcowin

Dexcowin ADX4000W Bedienungsanleitung

Libelium

Libelium MySignals Bedienungsanleitung

Acelity

Acelity V.A.C.ULTA 4 Bedienungsanleitung

Caputron

Caputron ActivaDose II tDCS Bedienungsanleitung

Plinth 2000

Plinth 2000 93CDT Bedienungsanleitung

GE SENOGRAPHE 800T Bedienungsanleitung

GE Definium 5000 Bedienungsanleitung

Kanmed

Kanmed GE-1380 Bedienungsanleitung

Huntleigh

Huntleigh FD1 Bedienungsanleitung

Stryker

Stryker SPR Plus Bedienungsanleitung

Tobii Dynavox

Tobii Dynavox I-Series Bedienungsanleitung

S-Capepod

S-Capepod Evac Cocoon Bedienungsanleitung