Laserscope GreenLight HPS User manual

Laser Operator’s Manual
Manufactured by
3070 Orchard Drive
San Jose, CA 95134
[phone]
[phone]

Part No. 0010-0009 Rev. A
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]

iii
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™....................................... xviii
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
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

iv
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

Preface
About This Manual
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 procedures, 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

vi Operator’s Manual
Conventions
NOTE: Points out additional information that may be helpful.
SCAUTION: 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]

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 or 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.
SCAUTION: 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.1
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.
12006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in
Practice Settings. AORN. Denver 2006: pg 565-570
Safety vii

viii Operator’s Manual
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
the laser safety officer. 2See 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 Z136.3-
1996, 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 = –Log10 (Filter Transmission)
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 10-5.
NOTE: It is required for everyone in the room to wear protective
eyewear.
2American 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)