Laserscope GreenLight HPS Operator's Manual

Laser Operator’s Manual

Manufactured by

3070 Orchard Drive

San Jose, CA 95134

[phone]

[phone]

Copyright

© 2006 Laserscope. All right reserved.

Notice

No part of this manual may be reproduced or transmitted in any form or by
any means without the written consent of Laserscope.

The information in this manual is subject to change without notice.

Disclaimer

Laserscope 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 Laserscope 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 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.

Trademarks

GreenLight HPS is a Laserscope trademark
Laserscope is a registered trademark of Laserscope.

Laserscope Corporate
Headquarters
3070 Orchard Drive
San Jose, CA 95134-2011
U.S.A.
Tel: [phone] (Customer
Service)
Tel: [phone]
Fax: [phone]
www.laserscope.com

Laserscope France, S.A.
Parc Technologique
18 rue du Bois Chaland
91090 Lisses, France
Tel: [phone]
Fax: [phone]

Laserscope (UK) Ltd.
Berwyn, The Pavilions
Llantarnam Park
Cwmbran, South Wales,
NP44 3UW
United Kingdom
Tel: [phone]
Fax: [phone]

Part No. 0010-0009 Rev. A

TABLE OF CONTENTS

Preface .............................................................................................. v

About This Manual......................................................................... v

Conventions................................................................................ vi

Who Should Read This Manual ....................................................... vi

Obtaining Help............................................................................. vi

Safety .............................................................................................. vii

Eye Injury...................................................................................vii

Burns........................................................................................ xiii

Reflection of the Beam from Instruments .......................................xiii

Ignition of Flammable Materials ....................................................xiv

Vapor/Smoke Plume....................................................................xiv

Electrical....................................................................................xiv

Operating Room Environment........................................................xv

Reference Sources ..................................................................... xvii

Safety Features of the GreenLight HPS

Safety Classifications...................................................................xix

Labeling ....................................................................................xxi

Section 1: Introduction.....................................................................1

1.1 System Overview.................................................................. 1

1.2 GreenLight HPS Fiber Optic..................................................... 6

1.3 General Instructions for Use ...................................................7

1.4 Sterilization.......................................................................... 8

™

....................................... xviii

Section 2: System Installation .........................................................9

2.1 Responsibility .......................................................................9

2.2 Space and Power Requirements ............................................ 10

Section 3: Operating the System.....................................................11

3.1 The Touch Screen and Footswitch.......................................... 11

3.2 Turning the System On........................................................ 12

3.3 Operating Procedure ........................................................... 16

3.4 Turning the System Off........................................................ 20

Section 4: Physician Information ....................................................21

4.1 Training Requirements......................................................... 21

4.2 Indications......................................................................... 21

4.3 Contraindications………………….… ............................................. 21

4.4 Potential Complications and Risks.......................................... 22

4.5 Precautions ................................................. 22

Section 5: Maintenance...................................................................25

5.1 Care of the Console............................................................ 25

5.2 Coolant Refill Instructions ................................................... 25

5.3 Preventive Maintenance Schedule ........................................ 26

iii

Section 6: Troubleshooting .............................................................27

6.1 System Prompts ................................................................. 27

6.2 Service Prompts.................................................................. 28

Specifications...................................................................................29

Warranty..........................................................................................30

Warranty Policy .......................................................................... 30

Product Returns.......................................................................... 34

Support Materials.............................................................................36

Clinical Competency Validation Checklist ........................................ 37

Supplies Needed......................................................................... 39

Laser Log................................................................................... 40

Operative Record Template .......................................................... 41

Pre-Procedural Patient Instructions................................................ 42

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 ............................................................ 4

List of Tables

Table W-1 Warranty Codes .............................................................. 32

Table W-2 Product Warranties.......................................................... 33

iv

About This Manual

Preface

This manual contains the safety, installation, operation, and maintenance
instructions for the GreenLight HPS

™

laser system. It also provides information

on the use and care of the system components, proper eye protection,

™

troubleshooting, and warranty for the GreenLight HPS

laser system.

• 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 1: Introduction describes the basic components of the system
and describes the interface features.

• 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
to start up the system, select treatment parameters, operating proced ures, and
how to turn the system off.

• Section 4: Physician Information contains information regarding
indications, contraindications, possible complications, precautions, and
post-treatment care.

• Section 5: Maintenance provides instructions on cleaning the system.

• Section 6: Troubleshooting presents a list of error messages and

codes, and gives suggestions on how to solve the problem.

• Specifications lists the product specifications. This section also includes

™

the labels found on the GreenLight HPS

laser system console and

provides the meaning of each symbol found on the system and the labels.

• Warranty contains warranty information and specific instructions for

™

returning the GreenLight HPS

laser system and GreenLight HPS™ fiber

optic for repair.

• Support Materials contains documents to help you organize the

™

operation and management related to the GreenLight HPS

laser system.

Preface v

Conventions

NOTE: Points out additional information that may be helpful.

S 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 HPS™ 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.

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 Laserscope Customer Response Center at:

• [phone] from inside the US, or

• Outside the US, contact your local distributor.

Laserscope France, S.A.
Parc Technologique
18 rue du Bois Chaland
91090 Lisses, France
Tel: [phone]
Fax: [phone]

Laserscope (UK) Ltd.
Berwyn, The Pavilions
Llantarnam Park
Cwmbran, South Wales,
NP44 3UW
United Kingdom
Tel: [phone]
Fax: [phone]

vi Operator’s Manual

Safety

¡ WARNING: Laser light presents a severe eye hazard and a potential for

burns or fire. The system’s aiming beam may be viewed by an
unprotected eye. Never activate the system treatment beam without
eye protection. It presents a severe eye hazard if viewed directly o r by
reflection. Avoid exposure to the laser beam. Take all necessary
protective measures in areas where the laser is being used.

Introduction

This section describes specific laser hazards and appropriate precautionary
measures.

Guidance for the safe use of lasers is given in IEC 825-1. It is also given in
two equivalent American National Standards. The first is ANSI Z136.1-2000,
The Safe Use of Lasers, and covers general use of lasers. The second
standard is ANSI Z136.3-1996, The Safe Use of Lasers in Health Care
Facilities, and covers specific use of lasers in medical applications. Refer to
the general ANSI Z136.1-2000 standard for the actual calculations for eye
protection.

This device complies with part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.

S 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.

Visible light and near-infrared 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.

1

2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in

Practice Settings. AORN. Denver 2006: pg 565-570

1

Precautions against eye injury should include wave-length specific laser
protective eyewear for the operating room staff. Patient’s eyes and eyelids
should be protected from the laser beam in a method deemed appropriate by

2

the laser safety officer.

See the Eye Protection Information Guide in this
section for more information regarding eye protection. Laser eyewear is not
interchangeable for a variety of lasers.

Eye Protection Information Guide

It is the responsibility of the hospital or medical institution where the laser
surgery is performed to establish a written policy on eye protection.

Several articles have been published stating the strong OSHA and JCAHO
(Joint Commission on Accreditation of Hospital Organizations) position to
adhere to ANSI Standards. Refer to ANSI Z136.1-2000 and ANSI Z136.3­1996, in conjunction with the recommendations of your Laser Safety Officer
(LSO) to develop your facility’s laser policy.

This guide will address some common questions raised on the issue of laser
eye protection. The information contained in this guide is designed to assist
you in tailoring a policy to fit the needs of your institution, particularly in

™

relation to the use of the GreenLight HPS

laser system.

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
for safe viewing in a medical facility. All the filters have optical densities
greater than 5.0 at 532 nm. The OD of the filters indicates how much the
light is attenuated and is defined as:

Optical Density = OD = –Log

(Filter Transmission)

10

A filter with an OD of 2 has a transmission of 1/100 or 10-2 while a filter with
an OD of 5 has a transmission of 1/100,000 or 10

 NOTE: It is required for everyone in the room to wear protective

eyewear.

-5

.

2

American National Standards Institute, Laser Institute of America, American National Standard for Safe

Use of Lasers in Health Care Facilities. (Orlando, FL: The Laser Institute of America. 1996)

viii Operator’s Manual

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.

• The 532nm Surgeon Protective Goggles (catalog number 10-7030). Have

a min. optical density (OD) of 5.0 at 532 nm. Although they have good
visible light transmission, the orange color of the plastic lens causes some
color distortion.

Eye Protection Product Reorder Information

• 532nm Surgeon Protective Glasses, Large Frame (catalog number 10-0008)

• 532 Surgeon Protective Glasses, Small Frame (catalog number 10-1350)

• 532nm Surgeon Protective Goggles, Standard Frame (catalog number 10-7030)

Safety ix

COMMON QUESTIONS ABOUT EYE PROTECTION

1. “O.D.” is marked on the laser eyewear. What does it mean?

O.D. stands for optical density. It is specific to the spectral wavelength
marked on the eyewear and represents the capability of the eyewear to block
out laser light. The higher the O.D., the greater the amount of light blocked
out. The O.D. marked on the eyewear is sufficient to provide protection for
the use described in the associated product insert.

Eyewear is not interchangeable for different wavelengths. Eyewear
designated for use at 532 nm should only be used when viewing the 532 nm
wavelength. For more information about the O.D. of Laserscope’s eyewear,
consult the product insert shipped with the specific eyewear.

2. Why is the eyewear for the GreenLight HPS

laser tinted?

The human eye is very sensitive to light in the green portion of the spectrum.

™

Since the GreenLight HPS

532 nm laser system operates in the visible green
light wavelength, protective eyewear for 532 nm must block a portion of this
green light to provide adequate eye protection.

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.
There is nothing dangerous about viewing green light at low intensity or the
red aiming beam. The eyewear is designed to protect against the high
intensity of the green laser light used to perform surgery.

4. Why do goggles fog and what can be done to prevent this from

happening?

The fogging of goggles is a common problem experienced by many laser
users. The warmth of the wearer, stress of the case, and coolness of the
procedure room are ideal conditions for condensation to form on all eyewear,
despite manufacturing design. The use of anti-fogging agents after cleaning
and before each case should reduce the fogging problem.

5. What is the potential for a fiber to break during a procedure and

cause eye injury?

During normal use, a fiber may incur stress when it is inserted into the
cystoscope. Stress is a concern when fibers are being used because small
nicks in the nylon jacket of the fiber can result in increased fragility.

™

laser system 532 nm

x Operator’s Manual

The probability that a person without eyewear will directly view a fiber
breaking is low, but can occur. The probability of the fiber breaking while
actually aimed at someone's eye is low. The following factors must all occur
simultaneously in order to result in hazardous exposure:

•

Alignment of the laser beam with the eye
Close proximity of the eye to the source of the laser light

•

Exposure time in excess of damage threshold

•

With proper use of the lase r 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.

6. Do I need laser eyewear with endoscopic cases?

Yes, protective eyewear is routinely required for most laser cases. In an
editorial article published by Rockwell Laser Industries, the use of eye
protection during endoscopic laser surgery was addressed. According to
Rockwell’s interpretation of ANSI Z136.1 (Section 4.3.6.2), Class 1 conditions
shall be considered as fulfilled for those limited open beam path lasers or
laser systems where measurements and analysis confirm that the accessible
levels during operation are at or below applicable maximum permissible
exposure (MPE) levels. By this definition, endoscopic laser surgery (ruling
out the possibility of a broken fiber) could be considered a Class 1 condition.

Laserscope supports the ANSI and AORN recommendations that
protective eyewear be available and worn during all laser procedures
by all personnel present.

7. What are some appropriate ways to protect the patient’s eyes

during laser surgery?

The patient should always be educated on the laser procedure and eye
protection requirements prior to the start of the procedure.

In addition, the following protective measures should be taken:

•

Use moist towels where appropriate.
If the patient is awake, use suitable protective eyewear, and instruct

•

the patient not to remove the eyewear.
If the patient is anesthetized, lubricate and tape the patient’s eyelids

•

shut.

•

Use a combination of moist towels, gauze eye pads, eyeshields, and
drapes to protect the eyes when the surgical site is on or near the face.

Safety xi

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 revie wing ANSI Z136.1-1986 and ANSI Z136.1-2000 and ANSI
Z136.3-1996, or by contacting:

• • Laser Institute of America

12424 Research Parkway, Suite 130
Orlando, FL 32826
Phone: (800) 34-LASER or www.laserinstitute.org

Rockwell Laser Industries
P.O. Box 43010
Cincinnati, OH 45243
Phone: (800) 94-LASER or www.rli.com

xii Operator’s Manual

BURNS

RECOMMENDED PRACTICE VIII: ALL PERSONNEL IN THE LASER
TREATMENT AREA SHOULD BE PROTECTED FROM FLAMMABILITY
HAZARDS ASSOCIATED WITH LASER USE.

3

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. 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 optic 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.

When using the fiber with the laser, the fiber device connector
should never be allowed to touch the floor or any wet surface. If
the fiber connector does contact a surface other than the laser
device port, dispose of the fiber in accordance with hospital safety
regulations.

REFLECTION OF THE BEAM FROM INSTRUMENTS

RECOMMENDED PRACTICE V: ALL PEOPLE IN THE LASER TREATMENT
AREA SHOLD BE PROTECTED FROM UNINTENTIONAL LASER BEAM
EXPOSURE.

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,

3

2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in

Practice Settings. AORN. Denver 2006: pg 565-570

ibid

Safety xiii

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. See Operating Room
Environment in this section for more information regarding flammable
materials.

VAPOR/SMOKE PLUME

RECOMMENDED PRACTICE VI: PERSONNEL WORKING IN THE LASER
ENVIRONMENT SHOULD AVOID EXPOSURE TO SMOKE PLUME
GENERATED DURING LASER SURGERY.

ibid

There is considerable concern about the biological plume created by
electrocautery units, bone saws and lasers. Current medical literature
recommends that a smoke evacuator and in-line filter be used to capture this
plume. The plume should be regarded as a source of active biological
material and a possible carcinogen.

ELECTRICAL

RECOMMENDED PRACTICE VII: ALL PEOPLE WORKING IN THE LASER
TREATMENT AREA SHOULD BE PROTECTED FROM ELECTRICAL
HAZARDS ASSOCIATED WITH LASER USE.

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 the Laserscope Customer
Response Center at [phone] 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.

ibid
ibid

xiv Operator’s Manual

ibid

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
RECOMMENDED PRACTICE III: ALL PEOPLE SHOULD KNOW

WHERE LASERS ARE BEING USED AND ACCESS TO THESE
AREAS SHOULD BE CONTROLLED.

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 S-1 is an example of a
sign suitable for use with the GreenLight HPS

4

™

laser system.

¡ WARNING: Warning signs are not interchangeable. Select a

sign that is appropriate for the wavelengths in use.

Figure S-1 GreenLight HPS™ laser system Warning Sign

4

2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in

Practice Settings. AORN. Denver 2006: pg 565-570

Safety xv

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 reconnected.
Once reconnection is made, 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 reconnected.

If the use of the remote door interlock is desired, the biomedical personnel at
the user’s facility can connect it. Access to the laser unit’s interlock is made
via a socket located on the back panel of the laser (see Section 1.1.

System Overview).

Safety Recommendations

The following are general safety r ecommendations for the operating room
and are not specific to the GreenLight HPS 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.

 NOTE: All lasers operate with a keyswitch. Keep the laser key in a

designated place and allow only trained personnel access to the key.

¡ WARNING: Do not fire the laser unless the aim beam is clearly

visible and directed at the targeted tissue.

xvi Operator’s Manual

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
edition: Recommended Practices for

Settings. Pg 565-570

Safety Considerations for the Use of Medical Lasers

The Nursing Spectrum of Lasers

Pfister, Kneedler, Purcell, Education Design, 1988, Pg. 70-72.
Lasers: The Perioperative Challenge

Ball, Kay A.. 3

Diffuse Reflections

Endoscopic Surgery: Is Laser Safety Eyewear Really Needed?

Radiant Resources Newsletter, Winter 1992, Rockwell Laser Industries.

rd

edition, Denver, AORN, Inc. 2004

Laser Safety in the Practice

Safety xvii

SAFETY FEATURES OF THE GreenLight HPS™ LASER SYSTEM

Safety Regulations

The United States Code of Federal Regulations, CFR Title 21, Ch. 1, Sections

1040.10, and 1040.11, requires that lasers have certain safety features. It
further requires 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 Laserscope’s GreenLight HPS
described in the following sections. All required labeling information is also
provided in these sections.

System Safety Features

Laserscope’s GreenLight HPS™ 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.

laser system are

• The laser provides an operating room door interlock connection, which

must be set up by the hospital personnel.

• 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 optic 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.

• 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.

xviii Operator’s Manual

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.

¡ 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.

SAFETY CLASSIFICATIONS

In accordance with UL 2601-1/IEC 60601-1, the product is classified as Class
I equipment at continuous operation with intermittent loading, which is not
protected against ingress of liquids. The product is not suitable for use in the
presence of a flammable anesthetic mixture with air or with oxygen or
nitrous oxide.

Performance & Safety Standards:

The GreenLight HPS™ laser system and accessories comply with U.S. Federal
regulations and the performance standards 21 CFR 1040.10 and 1040.11 for
medical laser systems. In addition, the information below identifies
Standards (European Norms and other Regulatory Guidelines) deemed as
relevant for addressing particular aspects of the Quality System, the
requirements for Medical Lasers, the Requirements for Medical Devices, and
the Essential requirements of the EU Medical Device Directive (Annex I).

ANSI Z136.1;200
ANSI Z136.3:2005
21 CFR Part 820
21 CFR Part 1040.10-11
MDD 93/42/EEC
WEEE 2002/96/EEC
EN60601-2-22:1996

EN 60601-1-4:1997
EN29001
ISO 11135
ANSI/AAMI ST81:2004
AAMI TIR 12:2004
AAMI TIR 30:2003
ISO 8600-1:1997

ISO 8600-3:1997
ISO 8600-4:1997
ISO 60601-2-18
CB Scheme
ISO 13485:2003
CMDCAS

Safety xix

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.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to other
devices, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the
following measures:

•

Reorient or relocate the receiving device.
Increase the separation between the equipment.

•

Connect the equipment into an outlet on a circuit different from that to

•

which the other device(s) are connected.
Consult the manufacturer or field service technician for help.

•

xx Operator’s Manual

(

)

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)

Figure S-2 Labeling of Front Panel of Laser

Emergency Off

International

Safety xxi