Laserscope 10-007X RFID sub-system for the GreenLight HPS User Manual manual

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Document Author:	Laserscope User

Laser Operator’s Manual
Manufactured by
3070 Orchard Drive
San Jose, CA 95134
(800) 356-7600
+1 (408) 943-0636
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: 800 356-7600 (Customer
Service)
Tel: 408 943-0636
Fax: (+1) 408 943-1051
www.laserscope.com
Laserscope France, S.A.
Parc Technologique
18 rue du Bois Chaland
91090 Lisses, France
Tel: 33/1 60 86 20 49
Fax: 33/1 60 86 14 88
Laserscope (UK) Ltd.
Berwyn, The Pavilions
Llantarnam Park
Cwmbran, South Wales,
NP44 3UW
United Kingdom
Tel: 44/1633-838081
Fax: 44/1633-838161
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™ ....................................... 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
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
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
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:
•
(800) 356-7600 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: 33/1 60 86 20 49
Fax: 33/1 60 86 14 88
vi
Laserscope (UK) Ltd.
Berwyn, The Pavilions
Llantarnam Park
Cwmbran, South Wales,
NP44 3UW
United Kingdom
Tel: 44/1633-838081
Fax: 44/1633-838161
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 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.
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. 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.
2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in
Practice Settings. AORN. Denver 2006: pg 565-570
Safety
vii
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. 2 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 = –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.
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 system 532 nm
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.
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 laser 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 reviewing ANSI Z136.1-1986 and ANSI Z136.1-2000 and ANSI
Z136.3-1996, or by contacting:
•
•
xii
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
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. ibid
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,
2006 Standards, Recommended Practices and Guidelines: Recommended Practices for Laser Safety in
Practice Settings. AORN. Denver 2006: pg 565-570
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. ibid
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 (800) 356-7600 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
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. 4
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™ 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
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 recommendations 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 Laser Safety in the Practice
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.. 3rd edition, Denver, AORN, Inc. 2004
Diffuse Reflections
Endoscopic Surgery: Is Laser Safety Eyewear Really Needed?
Radiant Resources Newsletter, Winter 1992, Rockwell Laser Industries.
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™ laser system are
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.
•
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:
•
•
•
•
xx
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.
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)
Emergency Off
(International)
Figure S-2
Labeling of Front Panel of Laser
Safety
xxi
FOOT
PEDAL
REMOTE
INTERLOCK
-CAUTION-
-CAUTIONSAFETY
AND COOLING
SAFETY
AND COOLING
SYSTEM
PROTECTION
FILL
SYSTEM
PROTECTION
FILL
COOLING
SYSTEM WITH
COOLING
SYSTEM
WITH
100%
D.I. OR
DISTILLED
100%
D.I. WATER
ONLY
WATER
ONLY
Figure S-3
xxii
Labeling of Rear Panel of Laser
Operator’s Manual
Section 1
Introduction
1.1 SYSTEM OVERVIEW
The GreenLight HPS™ laser system is a diode-pumped, frequency-doubled
Nd:YAG solid state laser. The laser system delivers a visible 532nm laser
light with a power setting range of 20 to 120W, in 10W increments.
The GreenLight HPS laser system features a “Plug and Play” capability that
self-adjusts to the facility’s individual voltage requirements, eliminating the
need for electrical modifications.
The laser system also consists of an air-cooled internal mechanism, ensuring
safe operating temperatures with no external water connections. Laser
energy emission and system status selection is activated through a surgeoncontrolled, color-coded footswitch or system touch screen feature located in
the laser console.
Safety
Figure 1-1
(1)
Display/Touch
screen
(2)
Card reader
(3)
Data Port
(4)
Storage
Compartment
(5)
Fiber Shield
(6)
Fiber pole
(7)
Fiber Optic Port
(8)
Emergency
Laser Stop
Button
(9)
ON/OFF Key
Switch
Front View of Laser
Operator’s Manual
Front View of Laser
(1) Display / Touch Screen - Displays operator information:
•
System status (Standby, Ready)
•
Laser output (in Watts). Separate display for vaporization and
coagulation.
•
Lights up when surgical beam is fired and indicates vaporization or
coagulation
•
Aiming beam brightness level
•
Joule meter (displays total number of Joules delivered)
•
Exposure time (displays total time light is emitted)
•
Button to arm and disarm the laser
•
Error codes and screen prompts
(2) Card Reader - Reads fiber card
(3) Data Port
(4) Storage Compartment
(5) Fiber Shield- Protects the fiber hub from inadvertent damages
(6) Fiber Pole - Secures and protects the fiber (retractable)
(7) Fiber Optic Port - Connection for fiber
(8) Emergency Laser Stop button - Shuts the entire system off in case of
emergency
(9) ON/OFF Keyswitch
Introduction
(1)
Rear Storage
(2)
Product ID Label
(3)
Upper Footswitch
Cord Storage Hook
(4)
Footswitch
Storage Hook
(5)
Lower Footswitch
Cord Storage Hook
(6)
Upper Power Cord
Storage Hook
(7)
Coolant Reservoir
(Fill)
(8)
Coolant Drain
(9)
Lower Power Cord
Storage Hook
(10) Rear Handle
(11)
Footswitch
Connection
(12)
Remote
Interlock
Socket
(13)
Electrical
Connection
(14)
Circuit
Breaker
(15) Foot
Brakes
Figure 1-2
Rear View of Laser
Operator’s Manual
Rear View of Laser
(1)
(2)
(3)
Rear Storage
Product ID Label
Upper Footswitch Cord Storage Hook – 2 upper hooks for coiling
footswitch cord
(4)
Footswitch Storage Hook – 2 hooks for footswitch storage
(5)
Lower Footswitch Cord Storage Hook – 2 lower hooks for coiling
footswitch cord
(6)
Upper Power Cord Storage Hook – 2 upper hooks for coiling power
cord
(7)
Coolant Reservoir – for refilling the internal cooling liquid (see
section 5.2 Coolant Refill Instructions)
(8)
(9)
Coolant Drain - for draining the internal cooling liquid (see section
5.2 Coolant Refill Instructions)
Lower Power Cord Storage Hook – 2 lower hooks for coiling power
cord
(10) Rear Handle – for easy positioning and movement
(11) Footswitch Connection
(12) Remote Interlock Socket - can be connected to the room door so
the footswitch will be disabled in the event of entry during lasing.
(13) Electrical Connection
(14) Circuit Breaker - automatically trips in the event of a power
overload, shutting off power to the system
(15) Foot Brakes
(16) Vent (under chassis) - might release small amounts of water when
system is in longer use
Introduction
1.2 GREENLIGHT HPS FIBER OPTIC
Product Description
The GreenLight HPS fiber (catalog number 10-2090) features a “side firing”
mechanism delivering up to 120W of 532nm light to tissue. The fiber is
guided to the treatment site by the continuous flow cystoscope, consisting of
an inner and outer sheath set, 30º forward oblique telescope, and visual
obturator.
The GreenLight HPS fiber is used to cut, coagulate and vaporize tissue in
endoscopic and open surgical procedures at a 70º forward defection angle to
the fiber axis. It can rotate 360-degrees, allowing tissue access in multiple
planes; and it is used in surgical applications where lateral delivery of laser
energy is desired. GreenLight HPS fibers are sterile and designed for single
use only.
GreenLight HPS Fiber Optic Specifications
Fiber size
600 microns
Fiber length
12 feet (3.66m)
Laser beam
Side fire
Sterilization
Single use
Fiber Optic Handling Guidelines
If the tip of the fiber accumulates tissue debris during a procedure, turn the
laser to STANDBY, remove the fiber from the cystoscope and carefully wipe
the tip clean with moistened sterile gauze.
The correct method of removing debris from the fiber is to gently wipe from
the tip of the fiber toward the control knob. When the procedure is
complete, dispose of the fiber using the standard hospital procedure for biohazardous material. GreenLight HPS fibers are single use devices and are
not designed to be re-sterilized or re-used.
Caution: Improper cleaning of the fiber tip may cause damage to
the fiber.
Calibration Information
GreenLight HPS fibers are tested at the factory to insure they have the
proper transmission factor. They do not have to be calibrated by hospital
personnel.
Operator’s Manual
1.3 GENERAL INSTRUCTIONS FOR USE
1. Remove the GreenLight HPS fiber optic from its sterile package using
aseptic technique. Be sure to bend back all the tabs from the fiber
package nest prior to removing the fiber.
2. Before starting the surgical procedure, the GreenLight HPS fiber optic
should be checked for damage.
3. Connect fiber hub into the fiber port on the laser system console.
4. Place the laser in READY mode to activate the aim beam. CAUTION: Do
not press the footswitch while checking the aim beam. Place the
distal end of the fiber on a non-reflective sterile surface and turn slightly
until the aim beam can be visualized. If the aim beam is not seen, the
fiber may be defective and should not be used.
5. Check for kinks or bright areas along the entire length of the GreenLight
HPS fiber. Do not use the fiber if it has been damaged.
6. Once the GreenLight HPS fiber has been checked, return the laser to the
STANDBY mode.
7. Position the GreenLight HPS fiber optic at the targeted treatment site.
The tip of the GreenLight HPS fiber should be in clear view and extended
approximately 1 to 2 cm. beyond the distal end of the endoscope. The
output beam of the fiber is aligned with the raised surface on the handle.
Therefore, the direction of the laser energy can always be determined.
8. Place the laser in READY mode to enable the footswitch control.
9. Laser software automatically corrects for fiber losses such that the power
level shown on the system video display indicates the actual amount of
power delivered to tissue.
10.Treatment times vary based on distance to tissue, power settings, and
other factors. The fiber should be maintained at a distance of 3 mm from
the tissue for maximum vaporization. The efficiency of vaporization will
decrease with increasing distance from the tissue and coagulation may
result.
11.Avoid contact of fiber tip with tissue. If, during the procedure the tip
accumulates debris, turn the laser to the STANDBY mode, remove the
GreenLight HPS fiber from the cystoscope, and carefully wipe the tip clean
with a sterile gauze or towel. Begin at the end of the fiber and wipe along
the fiber tip.
12.Never bury the cap of the fiber in tissue while firing the laser.
Introduction
1.4 STERILIZATION
Laserscope recommends that GreenLight HPS fibers be used in only one
surgical procedure. The GreenLight HPS fiber is a sterile, single-use,
disposable device and should not be re-used or re-sterilized. After the
completion of the procedure, dispose of the GreenLight HPS fiber following
the standard hospital protocol for bio-hazardous material. The GreenLight
HPS fiber is ethylene oxide sterilized and is not designed or certified for
multiple use.
Do not re-sterilize. Do not reuse.
ADDITIONAL INFORMATION ABOUT REUSING THE GreenLight
HPS FIBER
If you need more information on this subject, we recommend the AAMI
Technology Assessment Report on the Re-Use of Disposables. It can be
ordered from the Association for the Advancement of Medical
Instrumentation at: (703) 525-4890 (Part Number: TAR6-058). Other
questions can be directed to the Laserscope Customer Response Center at
(800) 356-7600 or (408) 943-0636.
STORAGE
The GreenLight HPS fiber should be stored under ambient conditions.
WARRANTY
The warranty for the GreenLight fiber optic covers only defects in the
material and workmanship. Should you need to return this product, call the
Laserscope Customer Response Center for “Return Authorization”.
Instructions for returning a product to Laserscope are detailed in the
Accessory Return/Repair Policy included with each device.
¡
WARNING: Never secure a fiber optic using a clamp as doing so
can result in an unsafe use condition. Use of a clamp can result
in the fiber optic being bent at sharp angles or fiber damage
which, in turn, can also result in an unsafe use condition. The
fiber optic can break causing a burn in the protective jacket and
the release of laser energy. If undetected, this condition can
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 or nonsterile surface. If the fiber connector does come into contact
with a surface other than the laser device port, dispose of the
fiber in accordance with hospital safety regulations.
Operator’s Manual
Section 2
System Installation
2.1 RESPONSIBILITY
This section provides general guidelines for the installation of the GreenLight
HPS™ laser system. This laser system has specific installation requirements.
It is the customer’s responsibility to fulfill these requirements prior to the
installation of the system. Failure to do so can result in intermittent operation
and even damage to the laser system. Please read the following information
carefully.
CAUTION: The crated system should be stored in a protected
area in temperatures between 50°F (10°C) and 104°F (40°C).
Laserscope’s Responsibility
A Laserscope Service Representative will install the laser system. Upon
arrival at the installation site, the representative will perform the following:
1. Verify appropriate power.
2. Uncrate the system and inspect for damage.
3. Perform all optical, electronic, and system checks necessary to bring the
laser into operation.
4. Inventory all shipped accessories.
Customer’s Responsibility
Provisions for proper power must be made prior to the receipt and
installation of the system. Return visits by service personnel for installation
will not be covered under warranty. Upon completion of the pre-installation
site preparation, call Laserscope to check shipment date and schedule
installation of the system.
Because the GreenLight HPS™ system uses standard electrical service and
has built-in cooling systems, installation requires minimal site preparation.
CAUTION: Do not attempt to turn on the system until it has
been installed and tested by a Laserscope Service Engineer.
Severe damage to the system will result.
System Installation
2.2 SPACE AND POWER REQUIREMENTS
POSITIONING OF THE LASER CONSOLE
•
Power connections must be within a radius of 6 feet from where the laser
console will be positioned in the treatment room.
The laser console, in turn, must be able to be positioned not more than 5
feet from the center line of the treatment table to ensure proper handling
of the fiber.
•
ENVIRONMENTAL REQUIREMENTS
The recommended temperature range for the room where the laser will be
operated is 55 to 85°F (13 to 30°C).
The laser unit’s dimensions are:
Width:
Depth:
Height:
Inches
16.50
33.75
43.25
Centimeters
41.9
85.7
109.9
POWER REQUIREMENTS
The power source for the GreenLight HPS™ laser system must be 200, 208,
220, 230 or 240 VAC, 30 Amp., 50/60 Hz. The laser will automatically adjust
to the voltage and frequency within this range.
The laser can function when some voltage change is present in the service
line, however the voltage may not vary by more than ± 10%.
In order for Laserscope to provide the correct electrical plug, the
customer must provide information about the installed receptacle
in the facility to the Customer Service Department prior to
installation. A 250 VAC, 30 Amp, 2 pole, 3 wire receptacle can be
used as long as it meets the system’s electrical requirements;
meets facility, city, county, state, and country ordinances; complies
with UL544/UL60601 for leakage current; and is ETL certified.
10
Operator’s Manual
Section 3
Operating the System
3.1 THE TOUCH SCREEN AND FOOTSWITCH
This section describes the touch screen and footswitch used to control the
GreenLight HPS™ laser system, and provides step-by-step instructions on
how to operate the system.
Laser parameters are selected and the system status is changed by using a
touch screen. You may also use the button on top of the footswitch to go
from READY to STANDBY laser status. The aiming beam is activated when
the system is changed from STANDBY to READY and the surgical beam is
activated by pressing the foot pedal. Press the yellow pedal for VAPOR and
the blue pedal for COAG.
Power is set by touching the – or + buttons on the display screen. An
audible tone will be heard when maximum or minimum levels are reached. If
at any time the laser is unable to deliver the requested power, an alert tone
is sounded and the actual power being delivered is displayed.
THE TOUCH SCREEN
Coagulation
Power Indicator
Vaporization
Power
Power Adjust
Buttons
Power Adjust
Buttons
Ready/Standby
Control and
Indicators
Resets Energy and
Lasing Time
Energy Indicator
Lasing Time Indicator
Changes the
Set-Up Screen
Operating the System
11
THE FOOTSWITCH
Ready/standby
button
Coag pedal
Vapor pedal
3.2 TURNING THE SYSTEM ON
The following procedure is recommended for system start-up:
1. Confirm the system circuit breaker is in the OFF position to prevent a
power surge to the system.
2. Connect the power cord to the wall outlet.
3. Turn the system circuit breaker to the ON position.
4. Turn the Keyswitch ON. The following screen will appear:
12
Operator’s Manual
5. The system will go through a series of self-tests. When the tests are
completed, the following screen will be displayed:
6. Located inside of each fiber box attached to the sterile fiber pouch is a fiber
card. Insert the card into the card reader. The screen will then prompt you
to attach the fiber.
Operating the System
13
7. Attach the fiber. Connect the fiber optic by pushing the connector into
the fiber optic port (arrow on connector facing up) and turning it ¼-turn
clockwise until it locks. The following screen will appear:
8. To select the treatment parameters, adjust the power by touching
+ under the VAPOR and COAG indicators.
–
or
9. The laser system has both an automatic joule counter and a lasing time
indicator, which displays the accumulated Joules and the lasing time. To
reset both counters, touch RESET. The following screen will appear:
10. Touch the appropriate box to select either Yes or No.
14
Operator’s Manual
11. The main screen will re-appear:
12. To change the system’s settings, touch press for Set Up at the bottom
of the main screen. The following screen will appear:
13. Adjust the desired setting by touching the – or
Press MAIN MENU to get back to the main screen.
indicators.
Operating the System
15
3.3 OPERATING PROCEDURE
14. Press the READY button to activate the red aiming beam and set up the
laser for emission. READY will change to orange.
15. The system is now ready for use in a procedure. Laser energy will be
emitted when the footswitch is pressed. The VAPOR or COAG
buttons will become active and an audio tone (adjustable) heard during
an emission. The system will return to STANDBY mode after two
minutes without any exposures. To go back to STANDBY, press
STANDBY or step on the Ready/Standby footswitch.
16. Treatment power may be changed at any time by touching the
+ buttons.
–
or
17. The laser emission can be disabled and the aiming beam turned off at
any time by pressing the STANDBY button or stepping on the
Ready/Standby footswitch.
18. (Press the red Emergency Laser Stop button for emergencies
only).
19. Take care not to cut or damage the cord between the footswitch and the laser.
16
Operator’s Manual
20.
If the fiber card or fiber optic is removed, the screen will display:
(or Please Attach a Device)
•
If less than 24,000 joules of accumulated energy has been used, then
re-insert the fiber card or fiber optic and continue.
•
If more than 24,000 joules of accumulated energy has been used, a
NEW fiber card and fiber optic must be inserted.
The GreenLight HPS fiber can be used up to the energy limit printed on the
seal of the fiber package. The user is alerted by an audible tone and a screen
message when less then 50,000 joules remain. If the energy limit has been
reached, a new fiber card and fiber optic must be inserted.
¡
WARNING: You will not be able resume the procedure with
the current fiber card if more than 24,000 joules have
elapsed AND the fiber card or fiber are removed or the
system is turned off.
NEVER REMOVE THE FIBER OR THE FIBER
CARD PRIOR TO COMPLETING THE PROCEDURE.
Operating the System
17
The following sequence of alerts will appear:
1. An audible tone will alert the user when 50,000 joules of usage remain
on the fiber. The remaining energy will be displayed on the screen.
2. The following message will appear on the screen when the user lifts
the foot off the pedal for the first time after less then 50,000 joules
remain:
18
Operator’s Manual
3. Press the screen as indicated to continue. The main screen will appear.
Joules and lasing time remaining will be displayed.
4. To get the laser into Ready Mode, press the Ready/Standby button.
5. The following message will appear when the energy limit has been
reached:
6. To continue a procedure when the energy limit has been reached, a
new fiber card and fiber optic must be inserted.
Operating the System
19
3.4 TURNING THE SYSTEM OFF
After the completion of the procedure, please follow the shut down
instructions as follows:
1. Record the Joule Meter total and lasing time, if desired.
2. Disconnect the fiber and discard in accordance to hospital policy for
biohazard waste. The fiber is a single use device.
3. Remove the used fiber card. Information on recycling cards is on the
back of the card. Accidental insertion of a used card will display a “Card
Expired” message with the date and time the card was used.
4. Turn the Keyswitch to the OFF position and remove the key. Store the
key in a safe place.
5. Coil the footswitch cable around the designated hooks and hang footswitch onto the rear panel of the laser.
6. Switch the circuit breaker on the rear panel of the laser to the OFF
position.
7. Disconnect the power cable from the wall outlet, observing appropriate
precautions for handling electrical equipment.
8. Coil the power cable around the designated hooks on the rear panel of the
laser.
CAUTION: Attach fiber port Dust Plug whenever a fiber is not
attached to the fiber port.
NOTE: If the laser is going to be stored for a long period of time, the
storage temperature must be between 50°F (10°C) and 104°F (40°C).
20
Operator’s Manual
Chapter 4
Physician Information
4.1 TRAINING REQUIREMENTS
The GreenLight HPS™ laser system should be used only by practitioners who
have been trained in its proper use. All users and support staff must have
thorough knowledge of its operation and its effects. Users should familiarize
themselves with this operator’s manual and with this device in a non-clinical
setting before using it for the treatment of patients in a clinical situation.
4.2 INDICATIONS
S CAUTION:
Federal (USA) Law restricts this device to sale by or
on order of a Physician.
The GreenLight HPS™ laser system and accessories are intended for use in
endoscopic (cystoscopic) 532 nm laser resection of the prostate for the treatment
of benign prostatic hypertrophy/hyperplasia (BPH). The device is not intended to
treat prostate cancer. The laser system has also been cleared for use on various
other soft tissue applications including bladder tumors and urethral strictures.
4.3 CONTRAINDICATIONS
The GreenLight HPS™ laser system and fiber optic 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 hemostasis of vessels over approximately two millimeters in
diameter
Where laser therapy is not considered the treatment of choice
Bleeding disorders and coagulopathy
Prostate cancer
Acute urinary tract infection (UTI)
Severe urethral stricture
Physician Information
21
4.4 POTENTIAL COMPLICATIONS AND RISKS
The same complications and risks that exist for conventional or traditional
surgery exist for laser surgery. These include, but are not limited to, the
following:
Pain: Short-lived pain may occur immediately following endoscopic/
cystoscopic laser therapy and may persist for as long as 48 hours.
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.
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 the bleeding.
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.
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.
Other complications may include:
• Allergic reaction to
• Chills
medication
• Urethral stricture
• Ulceration
• Delay in healing
• Edema
• Sloughing
•
•
Bladder neck
contracture
Epididymitis
4.5 PRECAUTIONS
•
The GreenLight HPS™ laser system is a surgical device to be used by
surgeons who have been trained in laser surgery through courses,
preceptorships, and under the guidance of other surgeons knowledgeable
in laser use. No claim is made that the laser will cure any medical
condition.
•
No claim is made that the GreenLight HPS™ laser system will cure any
medical condition, or entirely eliminate the diseased entity. Repeated
treatment or alternative therapies may be required.
22
Operator’s Manual
•
The surgeon should become fully acquainted with the unique surgical
effects produced with the GreenLight HPS™ laser system prior to clinical
use. These effects include coagulation, depth of penetration, and cutting
intensity.
•
Prior to turning the laser system on, operating room personnel and the
patient should be wearing protective eyewear suitable for 532nm laser
energy.
•
Laserscope has no clinical information or experience concerning the use of
Laserscope’s laser systems on pregnant women or nursing mothers.
•
The risk of combustion, perforation, and laser-induced hemorrhage, all of
which could cause serious or fatal complications, must be fully explained
to the patient.
•
As with conventional endoscopic treatment, adverse reactions such as
fever, chills, sepsis, edema and hemorrhage may occur following laser
treatment. In extreme cases, death may occur due to procedural
complications, concurrent illness, or the application of the laser. In the
case of the treatment of BPH, reported adverse events have been:
decreased or retrograde ejaculation; urinary retention; bladder neck
contracture; urethral strictures; hematuria; renal insufficiency;
incontinence; potential for re-treatment and shortness of breath.
•
Use of lower power levels and shorter exposure times are required in
order to prevent thermal damage to underlying structures; for example,
to thin-walled structures, such as the bladder.
•
The surgeon should carefully assess the target and surrounding tissue.
Then begin at the lowest power, with short duration exposures. Note the
surgical effect and adjust the settings until the desired effect is obtained.
•
Before operating the laser system, surgeons and all staff operating the
laser should carefully read and become familiar with the Operator’s
Manual.
•
Careful assessment of the target and surrounding tissue should be made,
and appropriate power should always be used.
•
Tissue perforation can occur if excessive laser energy is applied. This can
occur through the use of excessive laser power or the application of power
for excessive periods of time, particularly on diseased tissue.
•
Aim and use the laser only on tissues that are in full view.
•
Extra caution should be used when lasing tissue in close proximity to
known arteries, nerves and veins.
•
Flash fires can occur. A basin of water should be available in case a fire
should occur.
•
The laser may not be effective for coagulation in massive hemorrhage
situations. The surgeon must be prepared to control hemorrhages with
Physician Information
23
•
strident alternative non-laser techniques, such as ligature or
electrocautery.
•
Alterations in surgical approach or technique may be required to
accommodate laser use.
•
The surgeon should schedule follow-up visits in the same manner as for
any patient undergoing such surgery with other modalities.
•
Use caution when treating patients who have had difficulty with previous
endoscopic/cystoscopic procedures.
•
Extra precaution should be taken when radiation therapy and laser
therapy are to be used concurrently, including more stringent postoperative monitoring. Clinical studies have shown that patients who have
undergone radiation therapy present a greater risk of perforation or tissue
erosion.
•
To avoid damage from the treatment beam or treatment beam
backscatter, it is recommended that the fiber be fully in the visual field.
Do not fire the laser unless the aim beam is visible and directed at the
intended target.
24
Operator’s Manual
Chapter 5
Maintenance
Introduction
The GreenLight HPS™ laser system has been designed to provide trouble-free
operation with minimal maintenance. This section provides information on
the routine maintenance and care required for these laser systems.
The laser, cooling system, and control electronics are enclosed in a tamperresistant console. The console does not contain any user serviceable
components.
5.1 CARE OF THE CONSOLE
The console may be wiped down periodically with a cloth dampened with a
weak solution of water and mild detergent or a mild cleaning agent.
When cleaning the console, never do the following:
•
NEVER use harsh or abrasive cleansers, especially on the LCD display
screen panel. Damage to the finish will result.
•
NEVER pour water or any other liquid over the console. If any liquid is
spilled on the console and it is thought that some may have gone inside,
TURN THE UNIT OFF and call the Laserscope Customer Response Center.
5.2 COOLANT REFILL INSTRUCTIONS
The GreenLight HPS™ laser system uses a vented internal cooling system that
uses distilled or de-ionized water. Over time, some evaporation can occur
resulting in a “Water Low” system prompt. The following instructions
describe the water filling process for restoring the proper coolant level.
INSTRUCTIONS FOR USE
NOTE: The laser holds approximately 1,700 ml of distilled or deionized
water.
Maintenance
25
The following procedure is to be used to top off the water level for the
GreenLight HPS™ laser system only if a low water fault occurs.
1. Turn the circuit breaker off and unplug the laser.
2. Remove the reservoir cap in the rear of the laser.
3. Pour water into the filler reservoir until its level stops falling. Fill the
reservoir to just beyond the half way point, stop, and repeat until the
level stops falling.
4. Plug system in, turn on circuit breaker, and turn the laser key switch to
on.
5. Make sure that the filler reservoir is still about half full. Add water if
necessary.
6. Replace cap.
7. Continue with laser start up. If a “water low” message is still present, call
Laserscope Customer Service at (800) 356-7600 from inside the US or +1
(408) 943-0636 from outside the US; or call your local Laserscope
distributor.
5.3 PREVENTATIVE MAINTENANCE SCHEDULE
For optimum performance of the GreenLight HPS™ laser system, preventative
maintenance needs to be performed every six (6) months.
Please contact the Laserscope Customer Service at (800) 356-7600 or
(408) 943-0636 or your local Laserscope distributor for more information
concerning preventative maintenance or to schedule an appointment with a
Laserscope service repair representative.
26
Operator’s Manual
Chapter 6
Troubleshooting
Introduction
The GreenLight HPS™ laser system’s self-check mechanism will alert operating
room staff if there is a mechanical or software problem. A message will
appear on the screen at the time of system malfunction. Depending on the
severity of the problem, the system will either maintain status (Information
Messages) or require a solution before reactivating (System Prompts and
Service Prompts).
6.1 SYSTEM PROMPTS
A system prompt will appear and replace the main display. The following
messages require that corrective action be taken.
Message
Corrective Action
Emergency Stop
Touch the “Press Here to Continue” prompt.
Not In Ready
Press the Ready/Standby button
Attach a Fiber
Attach a valid device.
Invalid Fiber Type
Device attached is not valid GreenLight HPS™
device.
Remote Interlock Open
Close the Remote Interlock on the rear panel of the
system.
Device Port Overheat
Wait for device port to cool off. Contact
Laserscope Customer Service if problem persists.
Please Wait
The system is warming up (this should not take
longer than 5 minutes)
Water Low
Restore coolant level (see Section 5.2 Coolant
Refill Instructions). Turn system off, and add
distilled water.
Check Card Insertion
Reinsert fiber card. If problem persists, use one
of the spare fiber cards shipped with the system
and Contact Laserscope Customer Service.
Troubleshooting
27
6.2 SERVICE PROMPTS
An Error Code will appear and replace the main display. When these error codes
appear, the operator should note the problem number and contact Laserscope
Customer Service at (800) 356-7600 or call your local Laserscope distributor.
NOTE:
System Prompts:
Correct the problem as indicated in the
System Prompt table above and continue the
procedure.
Service Prompts:
The system can be reset if you see the
message “Press Here to Continue”. If the
system cannot reset itself, then it will require
servicing before it can be used again. In any
event, Service should always be notified of
any Service Prompt Errors.
28
Operator’s Manual
Specifications
Product specifications
Laser Type
Solid State, Frequency Doubled
Wavelength
532 nm
Average Power Levels
20-120 Watts in 10 Watt increments
Aiming Beam
Diode laser, red, 635 nm, <5mW
adjustable
0.05 - 0.15 radians full angle at half
minimum
Output Beam Divergence
Electrical Requirements
200-240 VAC @ 60 Hz or 50 Hz, 30 A
Operating Temperature
55° F (13° C) − 85° F (30° C)
Storage/Transport
Temperature
50° F (10° C) − 104° F (40° C)
Humidity
10% - 90%, non-condensing
Dimensions
Width: 16.5 inches (41.9.1 cm)
Depth: 33.75 inches (85.7 cm)
Height: 43.25 inches (109.9 cm)
Weight
335 pounds (152 kg)
Specifications
29
Warranty
WARRANTY POLICY
Laserscope warrants its products against defects in materials and
workmanship. The warranty period begins on the date of installation or
ninety days after the date of shipment, whichever is first, where installation
is included in the purchase price; and on the date of shipment where
installation is not included in the purchase price. The duration of the
warranty period and the extent of the warranty vary from product to product.
Every Laserscope product is assigned a warranty code that defines the nature
and duration of the warranty provided for the particular product. A copy of
Laserscope's Warranty Policy, which defines the warranty codes in detail and
assigns a code to each product, is available from Laserscope without charge
and is incorporated herein.
If Laserscope receives notice of such defects during the warranty period,
Laserscope shall, at its option, either repair or replace equipment or
components that prove to be defective. Equipment or components shipped
under this agreement or used as replacements under this warranty may be
refurbished or new equipment or components at Laserscope's option.
Warranty service is performed either on-site or at a Laserscope facility at
Laserscope's option. Where warranty service is provided on-site, the work
will be performed at the Buyer's facility, or a location that is mutually agreed
upon, at no charge. Where warranty service is provided at Laserscope,
products must be returned to a Laserscope service facility designated by
Laserscope.
Products may only be returned with the prior approval of Laserscope. A valid
Return Material Authorization Parts Request (PR) number must evidence such
approval. Buyer shall prepay shipping charges (and shall pay all duties and
taxes) for products returned to Laserscope. Laserscope shall pay for return
of products to Buyer.
Where warranty work is performed at the Buyers facility, such work will be
performed during normal working hours. If Buyer requests work to be
performed outside of normal working hours then Buyer shall pay reasonable
charges for the incremental cost of such work. Buyer agrees to make the
Equipment available to Laserscope during normal business hours.
Warranty
30
Limitation of Warranty
The foregoing warranty shall be voided where, in Laserscope's sole
judgment, there has been:
1. Improper or inadequate maintenance by Buyer, or service performed by
anyone other than Laserscope or a party authorized by Laserscope to
perform service on the specific item covered under this warranty.
2. Unauthorized modification or misuse.
3. Operation outside of the environmental specifications for the product.
4. Improper site preparation and maintenance, including but not limited to
improper electrical utilities.
5. Use of delivery devices or accessories not manufactured by Laserscope or
approved by Laserscope for use with Laserscope Systems.
Additional Terms, Mobile Systems Warranty
Due to the special situations surrounding GreenLight HPS™ laser systems that
are moved to numerous sites of service, the following conditions apply in
addition to the above:
1. Every mobile provider must have a clinical trainer on staff. This person
must be certified by Laserscope to provide clinical support to physicians
for their first cases and beyond.
2. Every mobile provider must have qualified (as certified by Laserscope)
technicians on staff to transport, setup and operate the GreenLight HPS™
during all cases. Annual re-certification is required.
Transport of the System
1. Every mobile provider must have suitable transportation for moving the
laser from site to site.
2. The vehicle must have a lift gate or ramp, depending on the height of the
vehicle, to load and unload the system.
3. The system must be transported in the original shipping crate or other
suitable method designed to absorb road shock (both vertical and
horizontal loads) to protect the system during transport. To absorb
vertical shock and vibration the floater (plywood base supported by foam
blocks) can be removed from the original shipping crate and installed in
the transport vehicle.
4. Exposure to freezing temperatures: The laser must be protected from
temperatures below 32 degrees Fahrenheit.
THE WARRANTY SET FORTH ABOVE IS EXCLUSIVE AND NO OTHER
WARRANTY, WHETHER WRITTEN OR ORAL OR IN ANY
COMMUNICATION WITH BUYER, IS EXPRESSED OR IMPLIED.
LASERSCOPE SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE.
31
Operator’s Manual
THE REMEDIES PROVIDED HEREIN ARE BUYER'S SOLE AND
EXCLUSIVE REMEDIES. IN NO EVENT SHALL LASERSCOPE BE LIABLE
FOR DIRECT, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES,
(INCLUDING LOSS OF
PROFITS) WHETHER BASED ON CONTRACT, TORT OR OTHER LEGAL
THEORY.
Warranty Codes
Table W-1 summarizes the warranty codes assigned to Laserscope products,
and lists the warranty period for each code.
Warranty Code
Warranty
Period
Commencement
Date
12
12 months
6 months
3 months
1 procedure
None
Installation
Shipment
Shipment
Shipment
N/A
Table W-1
Warranty Codes
NOTE: All warranty periods are expressed in months or number
of procedures.
Warranty
32
Product Warranties
Table W-2 summarizes the product warranties and the products to which
they apply.
NOTE: The products listed under Warranty Code 1 in Table 2 are
examples only. This list is not inclusive.
Warranty
Code
Products Covered
Notes
12
Parts & Labor
for 12 months
from Installation
not to exceed 15
months from
shipment
GreenLight HPS™
laser system
--
Adapter Plates & Rings
Eye Protection Filters
Surgeons Glasses &
Goggles
Replacement parts will
be warranted for the
remaining amount of the
90-day warranty or 30
days, whichever is the
longest.
Manuals and Literature
Products Not Listed
--
Parts & Labor
for 3 months
from Shipment
No Warranty
Provided
Table W-2
Product Warranties
In addition to the above warranties, service visits will warranty Parts & Labor
for 30 days from completion of the billable service repair or shipment of
part(s).
33
Operator’s Manual
PRODUCT RETURNS
Accessory Return/Repair Policy
Laserscope’s product insert, Accessory Return/Repair Policy, is contained in
this section. Please refer to this insert for answers to questions on return
and repair policies and procedures for end-users of Laserscope accessories.
All returns are handled by the Laserscope Customer Response Center at
(800) 356-7600 or (408) 943-0636. After hours response will be handled on
a call back basis.
Warranty
34
35
Operator’s Manual
Support Materials
To help you and your staff organize the operation and management related
to the GreenLight HPS™ laser system, Laserscope has developed a package
of practice assistance documents. Listed below are the forms that are
included in this chapter. For printing and customizing purposes, the forms
are also included on the CD supplied with this manual.
•
Clinical Competency Check List
•
Equipment Check List (OR equipment needed for the procedure)
•
Laser Log (Check list and log for operation of the GreenLight
HPS™ Laser System)
•
Operative Record Template. (The document is a template and
must be customized for each individual patient treatment. The
document must not be used as a preprinted operative record.)
•
Pre-Procedural Patient Instructions
•
General Post-Procedural Instructions for Patients
Warr
Support Materials
36
Warr
Clinical Competency Validation Checklist
GreenLight HPSTM Surgical Laser System
Name/Title_____________________________________________________Date____________
Unit/Department ________________________________________________________________
Performance Criteria
1.
Completed basic training course highlighting laser
safety and physics specific to the GreenLight HPS™
laser system and procedures performed in the facility.
2.
Prepares surgical suite for laser use:
• Covers all windows with opaque covering (placed
on inside of window)
• Posts laser warning signs, specific to the laser
being used on all access doorways
• Inspects laser safety eyewear for scratches or
damage
• Has laser wavelength specific safety eyewear
posted at all access doors to surgical suite
• Fire extinguisher and basin of water are
immediately available
3.
Performs proper laser system setup steps:
• Knows location of laser serial number
• Inspects power cord for damage prior to
connection to wall outlet.
• Demonstrates connection of foot pedal to
laser
• Turns on circuit breaker at rear of laser
• Powers laser on
• Observes self-test
• Inserts fiber card successfully
• Connects GreenLight HPSTM fiber to laser correctly
• Identifies fiber serial number (located at machine
connection of laser fiber)
• Places GreenLight HPSTM fiber in fiber support pole
• Knows location of Emergency Laser Stop
Button
4.
Laser Safety During Procedure
• Ensures that all personnel in room wear wavelength specific laser safety goggles
• Ensures that patient’s eyes are appropriately
protected. Patients who are awake are given
wave-length specific goggles. Patients who
undergo general anesthesia are provided with
other appropriate protection such as wet eye pads
or laser-specific eye shields.
• Demonstrates proper placement of foot-pedal and
black connecting hose in a position convenient to
the surgeon; preventing unintended footswitch
activation or potential damage to the cord by the
laser, personnel, or other equipment.
Criteria Met
Initials
and Date
Comments
• Removes unneeded footswitches from the vicinity
of the laser footswitch, preventing possible
surgeon confusion and inadvertent firing of the
laser.
• Demonstrates use of “READY/STANDBY” button
on touch screen and footpedal
• Knows how to adjust laser power settings
5.
Knowledge/assistance during procedure
• Recognizes when a fiber needs cleaning
• Knows proper method of cleaning fiber (from
distal to proximal end of fiber)
• Recognizes importance of keeping blue arrow in
visual field at all times, and reminds surgeon
appropriately
• Understands safety implications of placing laser in
STANDBY/READY modes when not being
actively used.
• Verifies relative fiber degradation status by
requesting that aiming beam be examined at
appropriate times during procedure
6.
Laser Shut-down
• Records Joules, power settings and duration of
laser time used during procedure on laser log
• Powers laser off
• Turns off circuit breaker
• Disconnects power cord and stores it properly at
rear of laser
• Returns key to designated secured area
• Collects and accounts for all laser protective
eyewear and stores them in protective cases
• Removes window coverings from access
doors/windows
• Removes laser warning signs and stores them
in appropriate location.
• Cleans and stores foot pedal on rear panel
storage rack.
Evaluator Name __________________________________
Title ____________________________________________
Evaluator Signature _______________________________________
Date _____________________________________________________
SUPPLIES NEEDED
The following is a list of supplies needed to perform a procedure with the GreenLight
HPSTM laser system.
STERILE SUPPLIES
•Continuous flow laser cystoscope (2224 Fr) consisting of:
− Outer sheath
− Inner sheath (laser bridge)
− Visual or blunt obturator
− 30º telescope
• Seal for fiber port of cystoscope
• Video camera or sterile camera drape
• Fiberoptic cable
• De-fogging agent (anti-fog) for
telescope, camera, and video camera
insert(optional)
• Laserscope GreenLight HPS™ side-fire
laser fiber optic
• 0.9% Saline solution for irrigation
(approx. 8-12 units of 3 liter bags at
room or body temperature)
•
•
•
•
•
•
•
•
•
•
•
•
TUR-Y irrigation tubing
Suction tubing
Cystoscopy pack
Cover for back table (instrument
trolley)
Sterile gauze (4'' x 4'')
K-Y Jelly
Sterile towels (4)
Sterile gowns
Prep solution of choice
Sterile gloves
Sterile bowl for irrigation (if desired)
Have available:
− Van Buren sounds
− Foley catheter (16 - 20Fr. 5cc 2way)
− Urinary drainage bag
− 10 cc syringe
NON-STERILE SUPPLIES
• GreenLight HPS™ Surgical Laser System
• GreenLight HPS™ fiber card (supplied in fiber package)
• Laserscope video camera insert marked O.D. 5 at 532 nm (diam. 1.25'' [Part No.
10-0721] or diam. 0.95'' [Part No. 10-0722] dependent on video camera and
telescope model). Both video camera inserts are delivered with each GreenLight
HPS™ surgical laser system. Soak insert in alcohol to clean and let it dry prior to
the procedure.
• Eye protection glasses for 532 laser labeled O.D. (optical density) 5.0 at 532 nm
(for everyone in room including the patient).
• Laser warning signs on all entrance doors to the room
• Opaque window covering for laser safety required for all windows
• Light source
• Video cassette recorder (VCR, CD-RW, DVD-RW) (optional)
• G.U. Stirrups
• Irrigation collection bottles (or floor drain)
• Irrigation/suction pump (optional)
If you have any questions, please contact our Customer Service Department at
(408) 943-0636 or (800) 356-7600 (inside the US and Canada only). International
customers, please dial ++1 (408) 943-0636.
Laser Log
Date:
OR #
Surgeon
Patient
Anesthesiolgist
Pre Op Dx
Anesthesia
Post Op Dx
General
Spinal:
Pudendal Block
IV Sedation
Procedure
Laser s/n
Prostate Gland Size:
Fiber lot #
Fiber lot #
Fiber lot #
Circulating Nurse
10-209010-2090
10-2090
If more than one fiber used, please note joules
expended per fiber under comments section
Scrub Nurse
Total # of fibers used
Laser Operator
LASER SAFETY PROCEDURES
Yes
Yes
Windows covered
COMMENTS:
AM/PM
Laser Off
Lasing Time
min
Power Settings Used:
AM/PM
sec
watts
time
watts
watts
time
time
watts
watts
time
time
watts
time
watts
watts
time
time
watts
time
No
Yes No
Fire Protection
(Fire extinguisher and water basin in room)
Yes
Laser On
No
Laser Warning Signs on Doors
Wavelength-specific eyewear
used
No
OPERATIVE RECORD TEMPLATE
The operative record must be customized for each individual patient
treatment. The document must not be used as a preprinted
operative record.
PATIENT’S NAME AND DATE OF TREATMENT.
_____________________________anesthesia for the procedure was jointly
selected by the patient and his anesthesiologist. The patient was taken to the
operating room, placed in the dorsal lithotomy position and prepped and
draped in the usual sterile manner. The prostate size was estimated to be
_____ g during previous examination.
A ___Fr continuous-flow cystoscope was connected to saline solution
irrigation and inserted into the bladder without difficulty in the usual fashion.
A preliminary cystoscopic examination was performed during which the
ureteral orifices, bladder neck and verumontanum were identified. The
GreenLight HPS™ laser was set at ___watts. The GreenLight HPS BPH™ laser
fiber was introduced through the working channel of the cystoscope. The
median lobe was identified and it was vaporized down to capsular fibers. The
bladder neck was then vaporized as far laterally as possible to open up the
prostatic urethra. The median lobe was vaporized from the bladder neck to
the verumontanum. The left and right lateral lobes were vaporized from the
bladder neck to the verumontanum,. Vaporization was continued until the
capsular fibers were visualized or until the lateral lobes were adequately
vaporized. The proximal adenoma was vaporized first, then the scope was
withdrawn to the verumontanum and the most distal adenoma was
vaporized, always ensuring that the verumontanum was well isolated. By
serially vaporizing the obstructing tissue, a wide open prostatic urethral
channel was created. A total of _______ joules were used during the
procedure.
During the procedure, any bleeding vessels were effectively controlled. At the
end of the procedure, the bladder neck, ureteral orifices, and verumontanum
were again inspected, and found to be intact, and without evidence of
incidental laser beam damage. The bladder was filled with saline solution
irrigation, and the continuous flow cystoscope was removed. External
pressure was applied to the dome of the bladder to ascertain the quality of
the urinary stream. A strong urine flow was achieved, with minimal evidence
of bleeding. A ___Fr (5cc) Foley catheter to straight drainage was inserted.
The patient was transferred to the PACU (Perianesthesia Care Unit) in good
condition.
PRACTICE NAME HERE
PRE-PROCEDURAL PATIENT INSTRUCTIONS
1. Call your doctor if your condition changes, or if you develop a cold,
infection or fever.
2. Let your doctor know if you are taking any blood thinners such as aspirin,
aspirin-containing medications, Coumadin® or Plavix®. Your doctor may
recommend that you stop taking these medicines several days prior to the
GreenLight HPS™ procedure.
3. Take any antibiotics as prescribed by your doctor.
4. Ask your doctor to write prescriptions for any medications he thinks you
should take before the day of your scheduled procedure. This will allow
you to have those medications “on hand” when you leave the surgery
center, instead of having to depend on someone else to take them to a
pharmacy for you.
5. Write down any questions you have about the procedure. Bring them
with you. There will be plenty of time to answer your questions before,
during, or after your procedure.
6. You may eat and drink as usual the night before. Your urologist or
anesthesiologist may allow a clear liquid breakfast, depending upon the
time of day your procedure is scheduled. If you are scheduled to have
your procedure before noon, do not take anything by mouth after 12:00
midnight the night before.
7. Wear comfortable, loose-fitting clothing to the hospital or ambulatory
surgery center on the day of your procedure.
8. Bring all medications with you on the day of the procedure.
9. Ask your urologist or the anesthesiologist if you should take your
regularly prescribed medications on the day of the procedure.
10.Please plan to be at the hospital/ASC at least 2 hours prior to your
scheduled treatment. Remember that you will also need to spend some
time post procedure to recover from anesthesia prior to being discharged
to home. If your doctor has indicated that you will need to stay overnight
in the facility, please arrange for someone to pick you up the next
morning at ______a.m.
11.Arrange for transportation home; you may not drive or operate dangerous
equipment for 24 hours after the procedure. (If you have spent the night
in the healthcare facility, you will still need to arrange for a ride home.)
12.If you have any questions, or cannot keep this appointment, please call:
_______________________________
Practice/MD/RN Name
__________________________
Phone
Coumadin is a registered trademark of DuPont Pharmaceuticals Co., Wilmington, DE 19898
Plavix is a registered trademark of Sanofi-Synthelabo, Paris 75013, France
PRACTICE NAME HERE
GENERAL POST-PROCEDURAL INSTRUCTIONS
1. You may need to wear a catheter to drain your bladder after the
procedure, depending upon how much swelling your doctor thinks may
occur immediately following the PVP procedure. This catheter is generally
removed within 24 hours.
2. Do not drive or operate dangerous equipment for 24 hours following
anesthesia.
3. Avoid beverages containing caffeine as they may cause bladder spasms.
4. Activity level: Take it easy for 2 to 3 days. Do not engage in activities
requiring heavy lifting, gardening, bicycling etc. This will increase the
pressure your abdomen puts on the bladder, and may result in blood in
your urine.
5. Take all medications as directed. Typical medications may include:
a.
b.
c.
d.
Antibiotic (prevents infection).
Non-steroidal anti-inflammatory drug (reduces inflammation).
A drug to reduce bladder spasms.
Mild over-the-counter pain reliever as needed.
6. Do not engage in sexual activity for 2 weeks.
7. Unless you have been advised to limit your fluid intake due to another
medical condition, drink one glass (8 oz. or 1/4 liter) of water for every
hour you are awake, about 64 oz. (or 2 liters) per day.
8. Please call the office at ___________________________ to schedule a
follow-up appointment.
9. Please call the office immediately if any of the following symptoms
appear:
a.
b.
c.
d.
Bright red bleeding in urine with a heavy clot.
Fever over 101º F (38°C).
Inability to urinate for more than 4 hours.
Feeling of bladder fullness that does not go away after urinating.
YOUR CONTACT PERSON, _______________________________, CAN
ANSWER ANY NEEDS OR CONCERNS YOU MAY HAVE.
THE TELEPHONE NUMBER IS: ____________________________.

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