AMS GreenLight XPS Laser System Operators Manual Rev B

AMS™ GreenLight XPS™ Laser System System Operator’s Manual 0086 EU Authorized Representative:

Manufactured by:

American Medical Systems Europe B.V. Straatweg 66H 3621 BR Breukelen The Netherlands Tel: + 31 (0) 346 258 100 Fax: + 31 (0) 346 258 130

American Medical Systems 3070 Orchard Drive San Jose, CA 95134-2011 USA Customer Care: U.S. Toll Free: 800 356 7600 Tel: + 408 456 3585 Fax: + 408 428 0512 www.AmericanMedicalSystems.com

EC

REP

Contact List: American Medical Systems Australia Pty Ltd. Unit 39, Building F 16 Mars Road Lane Cove NSW 2066 Australia Tel: + 61 2 9425 6800 Fax: + 61 2 9427 6296 American Medical Systems Canada Inc. P.O. Box 461 Guelph, Ontario N1H 6K9 Canada Tel: + 519 826 5333 Fax: + 519 821 1356 American Medical Systems Brasil Av. Ibirapuera, 2907 12° - 1212 CEP 04029-200 São Paulo SP 04029-200 Brasil Tel: + 55 11 5091 9753 Fax: + 55 11 5053 9709

Part No. 0010-0240 Rev. B

Copyright © 2010 American Medical Systems. All rights reserved. Part No. 0010-0240 Rev B 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

TABLE OF CONTENTS

Preface About This Manual CONVENTIONS WHO SHOULD READ THIS MANUAL? OBTAINING HELP

Section 1: 1.1

Device Description

DEVICE DESCRIPTION... 1 Console Description... 1 FiberLife... 1 Coagulation... 2 Console Specifications... 2 Front View of Laser System... 4 Rear View of Laser System... 6 Accessories...8

Section 2:

Physician Information

2.1

INDICATIONS FOR USE ... 9

2.2

CONTRAINDICATIONS ... 10

2.3

POTENTIAL SURGICAL COMPLICATIONS AND RISKS... 10 Non-Thermal Complications and Risks:... 10 Thermal Complications and Risks:... 11

2.4

COMPLICATIONS AND RISKS BY INDICATION... 12 General Surgery... 12 Gastroenterology... 12 Gynecology... 13 Head and Neck/Otorhinolaryngology (ENT)... 13 Neurosurgery... 14

Ophthalmology... 15 Spinal Surgery... 15 Plastic Surgery... 16 Thoracic Surgery... 16 Urology... 17 Other complications may include: ... 18 2.5

WARNINGS AND CAUTIONS... 19

Section 3:

Safety

3.1

EYE INJURY... 23

3.2

BURNS... 23

3.3

REFLECTION OF THE BEAM FROM INSTRUMENTS... 24

3.4

IGNITION OF FLAMMABLE MATERIALS... 24

3.5

ELECTRICAL... 24

3.6

SAFETY CLASSIFICATIONS... 25

3.7 OPERATING ROOM ENVIRONMENT... 29 Laser Warning Signs... 29 Remote Door Interlock... 30 Safety Recommendations... 30 3.8

SAFETY FEATURES OF THE LASER SYSTEM... 30 Safety Regulations... 30 System Safety Features... 31

3.9

CONSOLE LABELING... 33 Front Panel of Laser System... 33 Rear Panel of Laser System... 34

Section 4: Instructions for Use 4.1

THE TOUCH SCREEN AND FOOTSWITCH... 35 The Touch Screen... 35 The Footswitch... 36

4.2

STEP BY STEP INSTRUCTIONS... 37 Preparation... 37 Procedure... 41 After the procedure... 43 How to Store the System... 43

Section 5:

Maintenance

5.1

CARE OF THE CONSOLE... 45

5.2

PREVENTATIVE MAINTENANCE... 45

5.3

COOLANT REFILL INSTRUCTIONS... 47 Instructions How to Refill Coolant... 47

Section 6:

Troubleshooting

6.1

COURTESY MESSAGES... 49

6.2

SERVICE PROMPTS... 52

Section 7: Installation 7.1

INSTALLATION... 53 The Responsibility of AMS... 53 The Customer’s Responsibility... 53 Positioning of the Laser Console... 53 Power Requirements... 54

Section 8:

Warranty

8.1 WARRANTY POLICY... 55 Limitation of Warranty... 56 Additional Terms, Mobile Systems Warranty... 56 Transport of the System... 56 Warranty Codes... 57 Product Warranties... 58

List of Figures Figure 1-1 Front View of Laser System... 4 Figure 1-2 Rear View of Laser System... 6 Figure 3-1 Laser System Warning Sign... 29 Figure 3-2 Labeling of Front Panel of Laser System... 33 Figure 3-3 Labeling of Rear Panel of Laser System... 34

Preface About This Manual This manual contains the safety, installation, operation, and maintenance instructions for the GreenLight XPS Laser System. It also provides information on the use and care of the system components, proper eye protection, troubleshooting, and warranty for the GreenLight XPS Laser System. • Section 1: Device Description describes the basic components of the

system and describes the interface features. • Section 2: Physician Information contains information regarding

indications, contraindications, possible complications, precautions, and post-treatment care. • Section 3: Safety provides recommendations to avoid bodily injury,

especially the use of protective eyewear. Read this section before attempting to operate the equipment when treating a patient. • Section 4: Instructions For Use gives you step-by-step instructions

on how to start up the system, select treatment parameters, operating procedures, and how to turn the system off. • Section 5: Maintenance provides instructions on maintaining and cleaning

the system. • Section 6: Troubleshooting presents a list of error messages and codes,

and gives suggestions on how to solve the problem. • Section 7: Installation provides the physical and environmental

requirements necessary to operate the GreenLight XPS Laser System, as well as information on how to move the instrument should you need to. • Section 8: Warranty contains warranty information and specific

instructions for returning the GreenLight XPS laser for repair.

Preface CONVENTIONS n

NOTE: Points out additional information that may be helpful.

p CAUTION: Alerts you to situations that could result in instrument damage, failure in a procedure, or incorrect results. u W  ARNING: 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 surgical procedure. 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. p 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 6: Troubleshooting for a list of problems and suggested solutions. 3. For additional information covering installation, medical applications, or any other questions, contact the appropriate AMS affiliate office: • For the U.S. and Canada, contact Customer Care: (800) 356-7600

toll free from inside the US, or +1 (408) 456-3585 from outside the US.

• For EMEA countries (including Germany, Spain, Norway, the

Netherlands, UK, and France), contact Customer Care: + 31 (0) 346 258 100

•

For Australia, contact the business office: + 61 2 9425 6800

•

For Brazil, contact the business office: + 55 11 5091 9753

• Or contact your local distributor

Section 1: 1.1

Device Description

DEVICE DESCRIPTION

The GreenLight XPS Laser System™ is designed for the ablation 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. 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.

Console Description The console is a diode-pumped Solid State Laser utilizing Nd:YAG laser gain medium and Acousto-Optic Q Switch. Primary wavelength is 1064nm. Frequencydoubling crystal is used to generate 532nm output beam. Quasi-CW pulse repetition rate is 15KHz to 22 KHz depending on output power. Pulse duration is ~100ns. Pulse energy is ~8mJ at maximum power (180W). The console generates visible green 532nm 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 to 40W. The console features a “plug and play” capability that self adjusts to the facility’s individual voltage requirements, eliminating the need for electrical modifications of the operating facility. This Laser System also includes internal cooling mechanisms ensuring safe operating temperatures with no external water connection. Laser energy emission and system status changes are activated through a surgeoncontrolled, color-coded footswitch or system touch screen feature.

FiberLife The GreenLight XPS Laser System is equipped with the FiberLife feature. FiberLife 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 if for other reasons there is damage due to 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 an informative message.

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Section 1:

Device Description

FiberLife will also stop laser emission if the laser is accidentally fired while inside the cystoscope. Generally, this will prevent serious damage to the cystoscope. However, some discoloration of the metal may still occur which could increase the possibility of corrosion.

Coagulation A feature new with GreenLight XPS is pulsed coagulation. In this mode, activated when the coag footswitch is pressed, laser emission is pulsed at a rate of ~12Hz with a duty cycle of ~25%. This mode improves the coagulative effect when compared to the continuous emissions typically used by other lasers.

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

Vaporization: Quasi-CW (15kHz – 22kHz) Coagulation: Modulated at 12Hz, 25% duty cycle 5mW Perpendicular to fiber: 0.5±0.1,

Output Beam Divergence

Parallel to fiber: 0.25±0.1 radians full angle at half maximum 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

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Section 1:

Device Description

Dimensions

Width: less than 22 inches Depth: less than 36 inches Height: less than 58 inches

Weight

Less than 475 pounds

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Section 1:

Device Description

Front View of Laser System

(1) Display/Touch screen (2)

Card Reader

(3)

Data Port

(4) Storage Compartment (5)

Fiber Shield

(6)

Fiber Pole

(7)

Fiber Port Cover

(8) Emergency Laser Stop (9) ON/OFF Key Switch

Figure 1-1 Front View of Laser System 0010-0240 Rev. B

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Section 1:

Device Description

Front View of Laser System (1)

Display / Touch Screen - Displays operator information: •

System 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”

•

Error codes and screen prompts

(2)

Card Reader - Reads fiber card

(3)

Data Port - Used by service personnel

(4)

Storage Compartment

(5) Fiber Shield - Protects the fiber hub from inadvertent damage (6) Fiber Pole - Secures and protects the fiber (retractable) (7) Fiber Port Cover - Connection for fiber (8) Emergency Laser Stop - Terminates laser light emission in case of emergency (9)

ON/OFF Key Switch

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Section 1:

Device Description

Rear View of Laser System 1. Rear Handle 2. Upper Power Cord Storage Hook 3. Footswitch Storage Hook 4. Footswitch Cord Storage Hook

5. Footswitch Connection 6. Remote Interlock Socket 7. Service Port 8. Coolant Reservoir 9. Coolant Drain 10. Lower Power Cord Storage Hook 11. Circuit Breaker 12. Foot Brake 13 Electrical Connection

Figure 1-2 Rear View of Laser System 0010-0240 Rev. B

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Section 1:

Device Description

Rear View of Laser System (1) Rear Handle (2) Upper Power Cord Storage Hook - 2 upper hooks for coiling footswitch cord (3)

Footswitch Storage Hook - 2 hooks for footswitch storage

(4)

Footswitch Cord Storage Hook - 2 hooks for coiling footswitch cord

(5) Footswitch Connection (6) Remote Interlock Socket - can be connected to the room door so the footswitch will be disabled in the event of entry. (7)

Service Port - USB ports for factory Service only

(8) Coolant Reservoir - for refilling the internal cooling liquid (see section 5.3 for Coolant Refill Instructions) (9) Coolant Drain - for draining the internal cooling liquid (see section 5.3 for Coolant Refill Instructions) (10) Lower Power Cord Storage Hook - 2 lower hooks for coiling power cord (11) Circuit Breaker automatically trips in the event of a power overload, shutting off power to the system (12)

Foot Brake - Brake for locking and unlocking rear wheels

(13) Electrical Connection

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Section 1:

Device Description

Accessories Video Camera Filter A video camera filter must be inserted between the telescope and the camera (unless a comparable filter is built into the telescope). The filter comes in four versions, as shown in the table below. All versions 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 filter diameter depends on the video camera and telescope model. The two most commonly used video camera filters, Models 10-0721 and 10-0722, are delivered with each Laser System. Model #

Diameter

Transmission*

10-0721

1.25 inches

60%

10-0722

0.95 inches

60%

10-0725

1.25 inches

12%

10-0726

0.95 inches

12%

*visible wavelength except 532 nm

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. • 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.

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Section 2:

Physician Information

2.1 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 (e.g., laparoscopic) or open surgeries. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions); gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).  ynecology: Vaporizing, incising, or coagulating tissue associated with G 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 diskectomy. Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic 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 & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile hemangioma; urethral strictures; bladder neck

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Section 2:

Physician Information

obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia/hypoplasia (BPH).

2.2

CONTRAINDICATIONS

The GreenLight XPS Laser System should only be used by a qualified and trained surgeon. The use of the Laser System is contraindicated for patients: • Whose general medical condition contraindicates surgical intervention • Where appropriate anesthesia is contraindicated by patient history • Where tissue (especially tumors) has calcified • For hemostatis of vessels over approximately two millimeters in • • • • •

diameter Where 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 is any stricture with visible narrowing via urethrography or ultrasonography, with near total obstruction that makes passage of instruments difficult or dangerous. Care should be taken to avoid injury to urethral tissue.

2.3

POTENTIAL SURGICAL COMPLICATIONS AND RISKS

The same Potential Complications and Risks that exist for conventional or traditional surgery also exist for laser surgery. These include, but are not limited to, the following:

Non-Thermal Complications and Risks: Allergic reaction to medication Arrhythmia Aspiration Gas over-distension • Hypertension • Induced hemorrhage • Infection • Pain • Perforation • Pneumothorax • • • •

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Section 2:

Physician Information

Thermal Complications and Risks: • • • • • • • • • • • • •

Chills Edema Fever Induced hemorrhage Delayed hemorrhage Leukocytosis Pain Perforation Ulceration Delayed healing Embolism Sepsis Stricture

Some of the Potential Surgical Complications and Risks have been further explained below: Bleeding: Patients may experience bleeding at the site of the laser therapy during or after laser therapy. Post-treatment hemoglobin and hematocrit are recommended 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 following endoscopic/cystoscopic laser therapy and may persist for as long as 48 hours. Perforation: Perforation can occur as a result of excessive exposure to laser radiation. Perforation can also occur from tumor erosion, or as a result of any 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.

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