LUMENIS VersaPulse PowerSuite 20 User manual

VersaPulse
PowerSuite
20W Holmium Surgical Laser
Operator Manual

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
2 
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This manual is copyrighted with all rights reserved. Under copyright
laws, this manual may not be copied in whole or in part or reproduced
inanyothermediawithouttheexpresswrittenpermissionofLumenis.
Permittedcopiesmustcarrythesameproprietaryandcopyrightnotices
as were affixed to the original. Under the law, copying includes
translation into another language.
Pleasenotethatwhileeveryefforthasbeenmadetoensurethatthedata
given in this document is accurate, the information, figures,
illustrations,tables,specifications,andschematicscontainedhereinare
subject to change without notice.
Lumenis, the Lumenis Logo, andVersaPulse are registered trademarks
of Lumenis. PowerSuite, Select, VersaCut, CaseSaver, InfraTome,
DuoTome, and SlimLine are trademarks of Lumenis.
©The Lumenis group of companies
September 2004
0640-041-01
Revision B

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
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3
Regulatory European Representative:
Lumenis (Germany) GmbH
Heinrich-Hertz-Strasse 3
D-63303 Dreieich
Germany
Manufactured by Lumenis Ltd.
P.O.Box 240
Yokneam 20692
Israel

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
Contents 
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5
Operation
Introduction
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Characteristics of the holmium laser wavelength . . . . . . . . . . . . . . . . . . .11
Laser Preparation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
VersaPulse PowerSuite Components
. . . . . . . . . . . . . . . . . . . . . . . . .13
Laser console. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Optional printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
External door interlock plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Delivery systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Connection Instructions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Connecting the footswitch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Inserting the external door interlock plug. . . . . . . . . . . . . . . . . . . . . . . . .16
Plugging in the main power cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Connecting the optional printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Connecting the delivery system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Laser Console Basics
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Turning on the laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Restarting the laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Turning off the laser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Emergency off (STOP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Disconnecting the laser and delivery system . . . . . . . . . . . . . . . . . . . . . .26
Locking and unlocking the laser console wheels . . . . . . . . . . . . . . . . . . .28
Moving the laser console. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Control Screen Basics
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Control screen tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Changing the viewing mode: English or icon. . . . . . . . . . . . . . . . . . . . . .32
Setting the date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Changing the system beep volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Selecting the laser status: ready or standby. . . . . . . . . . . . . . . . . . . . . . . .38
Setting the aiming beam characteristics . . . . . . . . . . . . . . . . . . . . . . . . . .40
Contents

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
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Contents
Verifying the aiming beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Control screen messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Setting Treatment Values
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Setting the energy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Setting the pulse rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Understanding average power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
CaseSaver™ mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Viewing the Summary Screen
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Laser summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Starting a new treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Viewing the current or previous treatment . . . . . . . . . . . . . . . . . . . . . . . 56
Treatment summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Printing a treatment report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Preoperative Instructions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Intraoperative Instructions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Postoperative Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Maintenance Troubleshooting Guide
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
User Maintenance
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Annual laser maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Laser repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Clean the external surfaces of the laser console . . . . . . . . . . . . . . . . . . . 77
Clean the laser control screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Inspecting the debris shield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Electrical Utilities
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Systems designed for use outside of Europe . . . . . . . . . . . . . . . . . . . . . . 81
Systems designed for use in European communities under the MDD . . . 81
Hard-wired configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Removable or lockable wall socket and plug configurations. . . . . . . . . . 82
Specifications
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Laser safety eyewear. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Replacement parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
External Door Interlock Pin Assignments . . . . . . . . . . . . . . . . . . . . 86
Calibration Procedure
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Calibration instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Warranty Information
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Decontamination of Returned Equipment
. . . . . . . . . . . . . . . . . . . 89

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
Contents 
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7
Safety and
Regulatory
Introduction
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Laser Safety Eyewear
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
Additional Ocular Protection
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Additional Safety Considerations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Smoke evacuation—laser plume pollution hazards . . . . . . . . . . . . . . . . .99
Protecting nontarget tissues
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
Electrical hazards
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101
Fire hazards
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Regulatory Compliance
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Emergency stop push button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Key lock switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Laser emission indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
External door interlock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Protective housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Location of controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Safety shutter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
Manual reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
Electronic fault detection circuitry . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
Safety interlocks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
Precision of displayed values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
Location of regulatory and other system labels. . . . . . . . . . . . . . . . . . . .104
Indications
for Use
Indications for Use Specific to the Ho:YAG Wavelength
. . . . .111
General warnings, precautions, and complications to consider when using
the holmium wavelength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Arthroscopy indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .115
Urology indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
Urinary lithotripsy indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .118
E.N.T. surgery indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Gynecology indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
General surgery indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Gastroenterology surgery indications. . . . . . . . . . . . . . . . . . . . . . . . . . .132

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
Overview 
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9
Operation
Overview
• Introduction, 11
• Laser Preparation, 12
• VersaPulse PowerSuite Components, 13
• Connection Instructions, 15
• Laser Console Basics, 22
• Control Screen Basics, 30
• Setting Treatment Values, 44
• Viewing the Summary Screen, 56
• Preoperative Instructions, 63
• Intraoperative Instructions, 64
• Postoperative Instructions, 65

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
10 
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Operation

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
Introduction 

11
Introduction
The Lumenis VersaPulse
®
PowerSuite
™
20 Watt Holmium Laser is a
multispecialty laser, providing utility in urology, arthroscopy, ENT,
gastroenterology, gynecology, and general surgery applications. Fiber delivery
of holmium laser energy is ideal for minimally invasive surgery, offering broad
treatment options combining precise cutting, ablation, and coagulation.
The VersaPulse PowerSuite 20 Watt Holmium Laser is compact, compatible
with standard wall power, and features a swivel control screen for viewing
treatment settings from any vantage point. In addition to the standard
treatment controls, the laser includes a summary screen for case analysis,
research, or record keeping.The summary screen also provides the option of
printing a detailed report of your treatment settings for each procedure.
Lumenis lasers and delivery systems are precision medical instruments.They
have undergone extensive testing and with proper handling are useful and
reliable clinical instruments. If you have questions regarding your laser or
delivery system, contact your local Lumenis representative.
WARNING – Lasers generate a highly concentrated beam of light which may cause
injury if improperly used. To protect the patient and operating personnel, the entire
laser and the appropriate delivery system operator manuals, including all Safety and
Regulatory sections, should be carefully read and comprehended before operation.
Characteristics of the holmium laser wavelength
Theholmiumlaserwavelength is stronglyabsorbedbywater in tissue. Because
softtissue iscomprisedprimarily ofwater, holmiumlaserenergy iseffectivefor
excision, incision, ablation, and vaporization when in direct contact with soft
tissue, and for coagulation when a few millimeters from soft tissue.
The holmium laser wavelength falls in the near-infrared region of the
electromagnetic spectrum.These wavelengths are invisible to the human eye;
therefore, a low-power, visible aiming beam is used to target tissue.

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
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Operation
Laser Preparation
The laser is shipped directly from the factory to your site. Your local Lumenis
service representative initially uncrates, inspects, sets up, and installs the laser
to ensure that it is working properly. In addition, Lumenis provides in-service
training to ensure that your surgical staff is experienced with the performance
and safety considerations of the laser.
Thereafter, you or the nursing staff at your facility will perform the daily
maintenance routines associated with the laser and any delivery systems used
during surgery, including inspecting and cleaning the laser and delivery
systems; connecting, disconnecting, and sterilizing the delivery systems; and
verifying the aiming beam integrity. These procedures are detailed in this
manual and in the delivery system instruction guide.
If your scheduled surgical procedure requires disposable delivery devices or
accessories,it is helpfultohaveextra itemsreadyandavailablein the treatment
room should they be needed to complete a procedure.

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
VersaPulse PowerSuite Components 

13
VersaPulse PowerSuite Components
The VersaPulse PowerSuite 20 Watt Holmium Laser comprises:
•Alaser console with control screen
• An optional printer
• An external door interlock plug
•Afootswitch
• All electrical cables necessary for proper connection
VersaPulse PowerSuite laser console and components
VersaPulse PowerSuite 20W
Holmium laser console Footswitch
External door
interlock plug
Optional printer
Control screen

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
14 

Operation
Laser console
Thelaserconsolehousesthecontrolscreen,mainpowerkeyswitch,emergency
stop button, control electronics, laser source and associated optics, and power
supply. Fiber optic delivery systems attach to the fiber port on the front of the
console,enabling laserenergyto be deliveredtothetreatmentsite.Thecontrol
screen lets you select treatment settings outside of the sterile field.
Optional printer
The optional printer lets you print detailed treatment summaries for your
records or for clinical, academic, or economic evaluation. Your laser is
compatible with Hewlett-Packard DeskJet series inkjet printers.
External door interlock plug
The external door interlock plug must be inserted into the (external
interlock) receptacle on the rear of the laser console for the laser to operate. It
may be wired to an external switch to disable the laser if the treatment room
doors are opened during treatment.
Footswitch
The footswitch activates the laser treatment beam when depressed.
Delivery systems
A variety of fiber optic delivery systems are available for use with VersaPulse
PowerSuitelasers.Refertotheappropriatedeliverysysteminstructionguidefor
specific operating instructions.

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
Connection Instructions 

15
Connection Instructions
Before connecting the VersaPulse PowerSuite components, inspect the
individual components, cables, and electrical connections for dirt, debris, or
damage. Ensure that the electrical cables are not frayed or split. Contact your
local Lumenis service representative if any component appears damaged.
Connecting the footswitch
Insert the footswitch plug into the (footswitch) receptacle on the rear of
the laser. If the footswitch is not properly connected when the laser is turned
on,thefollowingillustrationappearsonthecontrolscreenuntilthefootswitch
is properly connected.
Connecting the footswitch
Footswitch

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
16 

Operation
Inserting the external door interlock plug
The external door interlock is a safety feature that disables the laser if the
treatment room doors are opened or the interlock plug is removed while the
laser is in ready mode.
Use of an external door interlock is optional; however, you must insert the
interlockplug intothe (externalinterlock) receptaclewhether or notyou
are using an external door interlock.The laser remains inoperative until the
plug is inserted into the receptacle.
If the laser becomes disabled during treatment because of an opened interlock,
the following illustration appears on the control screen.To resume treatment,
close the treatment room door or reinsert the interlock plug, and press
or .
Inserting the external door interlock plug
ready
External door
interlock plug

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
Connection Instructions 

17
Plugging in the main power cable
To plug in the main power cable:
1If necessary, plug the matching end of the main power cable into the main
power receptacle on the laser.
2Insert the main power plug into the wall socket.
Plugging in the main power cable
Main power receptacle
Main power plug
Main power cable

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
18 
 Operation
Connecting the optional printer
Before connecting the printer to the laser, refer to the printer operator manual
for specific instructions, such as inspection, assembly, and maintenance.
To connect the laser to the printer:
1Ensure that both the laser and printer are off.
2Attachthe DB25end of the printer cable to the (printer) portonthe laser
console.
3Attach the 36-pin end of the printer cable to the Centronics parallel interface
on your printer.
Connecting the optional printer
Printer port
(HP Deskjet printers only)
Optional printer

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
Connection Instructions 
 19
Connecting the delivery system
Before connecting the delivery system to the laser, refer to the appropriate
delivery system instruction guide for specific instructions, such as delivery
system inspection, sterilization, and assembly.
WARNING – Never inspect the delivery system while it is connected to the laser.
Accidental laser exposure can cause severe eye damage.
WARNING – To avoid possible damage to the optical system, use only qualified
Lumenis delivery systems. Using other than Lumenis delivery systems may jeopardize
safe operation or damage the laser and will void your Lumenis warranty or service
contract.
WARNING – Carefully inspect the delivery system sterile packaging to ensure that
it has not been torn or punctured. If there is any damage to the sterile packaging, do
not use the delivery system.
WARNING – When using a fiber optic delivery system, always inspect the fiber
optic cable to ensure that it has not been kinked, punctured, fractured, or otherwise
damaged. The fiber optic cable may be damaged if stepped on, pulled, left lying in a
vulnerable position, kinked, or tightly coiled. Do not clamp the cable with a hemostat
or other instruments. If sterile tape is used, always remove the tape before lifting the
cable. A damaged fiber optic cable may cause accidental laser exposure or injury to
the treatment room personnel or patient, and/or fire in the treatment room.

VersaPulse PowerSuite 20 Watt Holmium
0640-041-01, Rev. B, 09/04
20 
 Operation
To ensure sterility of the delivery system, use the following aseptic technique
when connecting the delivery system to the laser:
1The scrub nurse hands the laser connector to the circulating nurse.
2The circulating nurse removes the protective cap from the laser connector on
the delivery system.
WARNING – Whenremovingtheprotectivecap,holdthelaserconnector,not the
strain relief or fiber optic cable. Pulling on the strain relief or fiber optic cable may
damage the delivery system and result in unintended laser exposure.
CAUTION – Do not remove the protective cap from the laser connector in the
sterile field. Removing the protective cap in the sterile field may compromise sterility.
Proper handling of the laser connector