COOK Medical H-30 User manual

H-30
™
HOLMIUM LASER SYSTEM
USER MANUAL
UŽIVATELSKÁ PŘÍRUČKA
BRUGERVEJLEDNING
BENUTZERHANDBUCH
ΕΓΧΕΙΡΙ∆ΙΟ ΧΡΗΣΗΣ
MANUAL DEL USUARIO
KÄYTTÖOPAS
MANUEL D’UTILISATION
FELHASZNÁLÓI KÉZIKÖNYV
MANUALE D’USO
GEBRUIKERSHANDLEIDING
BRUKERHÅNDBOK
PODRĘCZNIK UŻYTKOWNIKA
MANUAL DO UTILIZADOR
РУКОВОДСТВО ПОЛЬЗОВАТЕЛЯ
ANVÄNDARHANDBOK
0088

Cook Medical © 2012
English .....................................................................................................................................................................................1-2
User manual
Česky........................................................................................................................................................................................2-2
Uživatelská příručka
Dansk .......................................................................................................................................................................................3-2
Brugervejledning
Deutsch ...................................................................................................................................................................................4-2
Benutzerhandbuch
Ελληνικά..................................................................................................................................................................................5-2
Εγχειριδιο χρησης
Español....................................................................................................................................................................................6-2
Manual del usuario
Suomi.......................................................................................................................................................................................7-2
Käyttöopas
Français....................................................................................................................................................................................8-2
Manuel d’utilisation
Magyar.....................................................................................................................................................................................9-2
Felhasználói kézikönyv
Italiano.................................................................................................................................................................................. 10-2
Manuale d’uso
Nederlands .......................................................................................................................................................................... 11-2
Gebruikershandleiding
Norsk..................................................................................................................................................................................... 12-2
Brukerhåndbok
Polski..................................................................................................................................................................................... 13-2
Podręcznik użytkownika
Português............................................................................................................................................................................. 14-2
Manual do utilizador
Русский ................................................................................................................................................................................ 15-2
Руководство пользователя
Svenska................................................................................................................................................................................. 16-2
Användarhandbok
Language Index

Cook Medical © 2012 1-2
Chapter 1: Introduction
Introduction to the H-30™................................. 1-4
About Cook Medical .......................................... 1-4
Holmium Lasers .................................................. 1-5
Laser Lithotripsy.................................................. 1-5
Device Description .................................... 1-5 - 1-7
System Specifications......................................... 1-8
Labels and Symbols............................................ 1-9
Chapter 2: Installation
Installation..........................................................1-11
Transportation ...................................................1-11
Unpacking the Laser System ................1-11 - 1-12
Contents.............................................................1-12
Ambient Operating Conditions ......................1-12
Filling the Cooling System with Water .. 1-12 - 1-13
Initial System Power On ........................1-13 - 1-14
Verifying Alignment and Calibration..............1-14
Chapter 3: Safety
General Warnings and Caution.......................1-16
General Safety Information..............................1-16
Staff Training......................................................1-16
Working Area ....................................................1-16
Repair and Modifications of the Device.........1-16
Eye and Skin Exposure.....................................1-17
Hazards ...................................................1-17 - 1-18
Interference with Other Devices.....................1-18
Chapter 4: Indications and Instructions for Use
Indications for Use............................................1-20
Surgical Applications........................................1-20
Warnings and Risks................................1-20 - 1-21
Parameter Determination ................................1-21
Setting the Pulse Width.........................1-21 - 1-22
Adjusting the Energy per Pulse.......................1-22
Surgical Complications and Risks........1-22 - 1-23
Contraindications for Laser Surgery...............1-23
Chapter 5: Operation
Laser Screens.....................................................1-25
Main Screen............................................1-25 - 1-26
Options Screen ......................................1-27 - 1-28
Laser Parameters....................................1-28 - 1-29
Turning the System Off.....................................1-29
Protection Against Unauthorized Use ............1-29
Error Messages ......................................1-29 - 1-30
Chapter 6: Maintenance
General Maintenance.......................................1-32
Cooling Water Level.........................................1-32
Power Cord .......................................................1-32
Labels .................................................................1-32
Replacing the Blast Shield....................1-33 - 1-34
Troubleshooting................................................1-35
Error Messages ......................................1-35 - 1-36
Chapter 7: Warranty Information
Warranty Statement..........................................1-38
Limits and Exclusions .......................................1-38
Warranty Period.................................................1-39
Warranty Procedure..........................................1-39
Table of Contents

Chapter 1
Introduction
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Cook Medical © 2012 1-4
Chapter 1
Introduction
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Introduction to the H-30™
The Cook Medical H-30™ Holmium Laser System and holmium laser fibers are effective
in the treatment of soft tissue disease and urinary stones. The H-30 has indications in a
variety of medical specialties including urology.
The following are urological indications for use: urethral strictures, bladder neck incisions,
ablation, and resection of bladder tumors, urethral tumors and ureteral tumors.
Multiple uses for lithotripsy and percutaneous urinary lithotripsy are also indicated:
endoscopic fragmentation of urethral, ureteral, bladder and renal calculi, endoscopic
fragmentation of kidney calculi, and the treatment of distal impacted fragments of
steinstrasse when a wire guide cannot be passed.
About Cook Medical
Choosing Cook Medical means choosing quality and innovation without compromise.
To attain the best results with the H-30 and avoid the risk of dangerous faults, please
thoroughly read this user manual before using the laser system.
Contact your sales representative if you have any questions regarding the operation or
performance of the H-30 Holmium Laser System and holmium laser fibers.
Cook Medical
750 Daniels Way, P.O. Box 489
Bloomington, IN 47402-0489 USA
800.457.4500 ext. 102146
customerrela[email protected]
www.cookmedical.com

Chapter 1
Introduction
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Cook Medical © 2012 1-5
Holmium Lasers
Holmium (Ho:YAG) lasers are versatile, covering a wide range of indications. Holmium
laser energy is largely absorbed by water, making it ideal for tissue ablation with minimal
lateral thermal damage. In the case of laser lithotripsy, laser energy vaporizes water in the
stone, causing it to break into smaller particles that pass easily though the urinary tract.
Laser Lithotripsy
Holmium lasers can treat any type of calculi, regardless of color or composition, from
the bladder to the kidney. A major advantage of a holmium laser is that its laser fibers
can be placed through small, flexible ureteroscopes with minimal loss of deflection or
irrigation. Because of the versatility and safety of holmium laser energy, the indications for
treatment have expanded to include stones larger than 2 cm.
Device Description
Name Laser Source
H-30 Holmium Laser System Ho:YAG
Front of Laser
Laser
Aperture
Emission
Warning Indicator
Emergency
Stop Switch
Figure 1

Cook Medical © 2012 1-6
Chapter 1
Introduction
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Bottom Rear of Laser
Top Rear of Laser
Key Switch
Product
Label
Warning
Label
Water Level
Indicator
Foot Switch
Storage
Water
Drain Port
MAINS
Label
MAINS
Switch
Remote
Interlock
Connector
Power Cord
Water Fill
Port
Air Purge
Port
Figure 2
Figure 3

Cook Medical © 2012 1-7
Chapter 1
Introduction
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Device Connections
The H-30 contains one laser source, emitting at 2.1 µm. The laser is delivered through an
optical fiber (holmium laser fiber) connected to the Laser Aperature. (See figure 1.)
Key Switch
The key switch turns the device on. There are two positions on the switch: ‘I’ (on) and ‘O’
(off). To power on the device, insert the key and turn it clockwise to the on position. To
power off, turn the key to the off position and remove it. (See figure 2.)
Emergency Stop Button
The emergency stop button allows the immediate shutdown of the device. In case of an
emergency, push the emergency stop button. To reset the emergency stop button, twist
and pull it out. (See figure 1.)
Control Panel
Figure 4

Cook Medical © 2012 1-8
Chapter 1
Introduction
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System Specifications
General Specifications
Electrical Requirements 230 V ~ +10%/50-60 Hz/10 A (30 W output)
115 V ~ +10%/50-60 Hz/20 A (30 W output)
115 V ~ +10%/50-60 Hz/15 A (20 W output)
Dimensions 20 in (W) x 23 in (D) x 51 in (H)
50 x 59 x 129 cm
Weight 230 lbs
104 kg
Operation Temperature 50°F - 77°F,
10°C - 25°C
Storing Temperature 41°F - 104°F,
5°C - 40°C
Relative Humidity From 30% to 85% (no condensing)
Cooling Air cooled
Electrical Protection Class I
Type B
Degree of Protection IP20 (IEC529)
Laser Specifications
Laser Type Flashlamp pumped CTH:YAG
Wavelength 2.1 µm
Power to Tissue 30 W
Energy/Pulse 0.5 - 3.5 J
Application Mode Pulsed
Pulse Width Short and Long
Repetition Rate 5 - 20 Hz
Delivery Device Wide range of flexible silica fibers
Aiming Beam Diode laser, green, 532 nm (adjustable < 3 mW)

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Cook Medical © 2012 1-9
Labels and Symbols
Chapter 1
Introduction
WARNING—Visible and
invisible laser radiation.
Laser Stop Laser Aperature Optical Fiber Applicator
Foot switch
laser activation device

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Chapter 2
Installation

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Cook Medical © 2012 1-11
Installation
The H-30 laser system should be installed by trained personnel upon initial receipt of the
laser system from Cook Medical. Any damage that occurs after transportation must be
corrected prior to use.
WARNING! Do not attempt to use the H-30 prior to trained personnel per-
forming the installation procedure.
Transportation
Transportation of the laser system must be performed in compliance with all local
safety laws.
The laser system must be packaged to protect it from damage, such as in the original
shipping crate. If the original shipping crate is not used for transportation, the system
must be secured to prevent damage. The handles can be used to tie the system to a
secure surface. The crate should only be moved using proper lifting and transporting
means, such as a pallet jack.
The laser system should not be subjected to excessive force, shock or vibration. If
excessive shock or vibration is suspected to have occured, the laser alignment should be
inspected by a trained technician.
If any water remains in the cooling system, the laser must not be subjected to freezing
temperatures. Freezing water within the laser cavity can damage optical components
such as the laser cavity, rod and flash lamp or mechanical components such as the heat
exchanger or water pump. If there is a possibility of freezing temperatures, the laser’s
cooling system should be drained of all water by attaching fill/drain tubes to both the
Drain and Air Purge ports on the rear panel of the laser system. (See figures 2 and 3.)
Storage humidity should not exceed 95%. If the laser is stored in a high humidity
location, it must be allowed sufficient time to reach equilibrium when introduced to a
cool operating environment. Failure to do this may result in damage to the optics from
condensation.
Unpacking the Laser System
Your H-30 laser system is shipped from the factory in a wooden crate to protect it
from damage during shipping. Before removing the laser system, inspect the crate
for damage. If there is evidence of damage, save all packing materials and notify the
shipping company by filing an insurance claim report.
Chapter 2
Installation

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Cook Medical © 2012 1-12
Chapter 2
Installation
A Cook sales or service representative will help you with the installation of the laser
system. If you have any questions, please contact Customer Relations. After the laser
system has been unpacked, please store the shipping crate and packing materials in a
safe location in case the laser system has to be transported in the future.
The crate can easily be disassembled and laid flat to be stored more easily.
Contents
The H-30 laser system is shipped with the following components and accessories. Please
take inventory of the items listed below and contact Customer Service if any items are
missing or damaged.
• Lasersystem
• Twokeystokeyswitch
• Footswitch
• Remoteinterlockconnector
• Containerofdistilledwater
• Plasticwaterbottleforllingthecoolingsystem
• Twoll/drain/airpurgetubes
Ambient Operating Conditions
The laser system should be used in a well-ventilated, air-conditioned operating room. The
procedure room temperature should be kept between 18-24°C (65-75°F) for optimum
system performance. In general, holmium lasers are very sensitive to temperature.
When the laser system reaches above 38°C (100°F), the safety circuits will prevent the
laser system from operating. The information bar on the touchscreen will read “Over
temperature.” The laser system may overheat for the following reasons:
• Improperventilation
• Theambientoperatingroomtemperatureisabove24°C(74°F)
• Thelasersystemhasbeenrunningathighpowerforanextendedperiodoftime
(more than 30 minutes)
• Theinputlinevoltageislowerthannormal,causingthecoolingfansorwaterpumpto
under-perform
Filling the Cooling System with Water
1. Connect a fill/drain tube to the laser system in the port labeled Air Purge.
2. Fill the supplied water bottle with distilled water and connect its output tube to the
water fill port on the laser system labeled Water Fill. (See figure 2.)
NOTE: Use distilled water only.

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Cook Medical © 2012 1-13
Chapter 2
Installation
3. Direct the output of the Air Purge tube into the distilled water container used to fill
the water bottle.
4. Hold the water bottle up and compress the output valve to allow water to flow into
the laser system.
5. Once some water has started to flow into the laser system, turn the laser system on
and continue filling the cooling system.
6. Turn off the laser system and refill the water bottle whenever necessary.
7. Repeat the process until only water is forced out of the Air Purge port.
NOTE: The laser system has built-in safety circuitry to detect when there is too little
water flow. If this circuitry engages while it fills with water, the information bar will
display “Low coolant flow.” Simply turn the laser system off and back on to continue.
8. Disconnect both the Water Fill and Air Purge tube and let the laser system run for a
few minutes to force any air in the system to the top.
9. Inspect the water level indicator on the rear panel. Repeat procedure until the red
float is at the top of the level indicator. (See figure 2.)
10. Store tubes and water bottle in a safe place for future use.
Initial System Power On
Review the previous sections in this chapter and verify that all site installation
requirements have been met. The laser system should only be operated in an area of
restricted access. Post a laser warning sign on each access door.
1. Connect the foot switch and remote interlock connector to the laser system. (See
figure 3.) Find the remote interlock connector supplied separately in the bag that
comes with the unit.
2. Connect the laser device to a suitable AC electrical outlet.
3. Ensure the emergency stop button isn’t engaged. (See figure 1.)
4. Turn the MAINS switch on. (See figure 3.)
5. Turn the key switch on. (See figure 2).
6. Lift the laser aperture cover and connect a 550 µm holmium laser fiber to the laser.
(See figure 1.)
NOTE: Do not over-tighten the laser fiber. The connector only needs to be finger
tight for proper operation.
7. After a few seconds, the information bar on the control panel screen will display
“STANDBY.” (See figure 4.)
8. Press the Ready button. (See figure 4.) The Ready progress bar will take about two
seconds to fill.

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Cook Medical © 2012 1-14
9. Once the Ready bar is fully lit, the information bar will display “READY to lase.” This
indicates that the laser system is operating normally. (See figure 4.)
10. Follow the instructions in the next section to verify alignment and calibration.
Verifying Alignment and Calibration
The laser system has been designed with many safeguards to prevent optical
misalignment due to shipping and normal operation. However, it is important to verify the
alignment and calibration of the laser system to ensure peak system performance. The
following test requires an energy or power meter calibrated to 2100 nm.
The following test is intended for laser systems capable of delivering the full 30 W
output power.
1. Set up laser system for lasing.
2. Verify that the 550 μm test fiber has clean surfaces on both the proximal connector
and distal ends.
3. Insert the 550 μm test fiber into the laser aperture.
WARNING! Wear appropriate safety eyewear. While the laser is in operation,
all personnel in the operating room must wear appropriate laser eyewear.
4. Set up laser power probe in front of and parallel to the distal face of the test fiber,
as shown. Be careful not to place the fiber tip too close to the probe, as the energy
density may damage the probe’s sensitive surface.
5. Set the power parameters to Short pulse width mode, 10 Hz, 0.5 J.
6. Press the Ready button and wait until the information bar displays “READY to lase.”
7. Depress the foot switch for 5-10 seconds until you attain a stable reading on the
power meter.
8. If the reading is not within 10% of the displayed
settings, the laser system is either misaligned
or out of tune. Please contact your sales
representative.
9. Repeat steps 7 through 9 for the following
settings as well:
a. Short pulse width mode, 10 Hz, 2.0 J.
b. Short pulse width mode, 10 Hz, 3.0 J. (NOTE:
Only for max output of 30 W.)
Chapter 2
Installation
Figure 5

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Chapter 3
Safety

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Cook Medical © 2012 1-16
General Warnings and Caution
The H-30 is a 30 W holmium laser system for surgical procedures. The device is
manufactured following the 93/42/EEC Annex II standard and it is identified as follows:
Device 30 W Holmium Laser System
Name H-30 Holmium Laser System
Category of the Device Laser for medical use
Manufactured By Cook Urological Inc.
1100 West Morgan Street
Spencer, IN 47460-9426 USA
General Safety Information
• Allpersonsoperatingthisequipmentmustunderstandtheinstructionsforoperation
and the instructions for safety specified in this manual.
• Onlyauthorizedindividualswithappropriatemedicallasertrainingandknowledge
should operate the laser system.
• Onlyauthorizedservicepersonnelshouldaccesstheinternalelectricalcomponents.
• Accesstotheusermanualshouldbeavailableintheworkingareaofthelaser.
• Allthewarninglabelsmustbekeptingoodcondition.
DO NOT dispose of this laser equipment in any location other than designated locations.
Staff Training
The use of the laser is restricted only to medical staff with experience using lasers.
Working Area
This H-30 is a Class 4 laser and must be used in a specific working area defined and
delimited following local and international standards (IEC/EN 60825-1: 2003-02).
Repair and Modifications of the Device
Only authorized service personnel should execute repairs and maintenance. Constructive
modifications are not permitted.
Note: Unauthorized repair or maintenance, and/or modifications to the laser system, will
void the warranty.
Chapter 3
Safety

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Cook Medical © 2012 1-17
Chapter 3
Safety
Eye and Skin Exposure
The working laser beam of the H-30 is invisible and, if exposed to the eyes, may cause
sight loss. The skin can resist a significantly higher amount of laser energy, but the laser
beam can seriously burn the skin.
A danger exists in any case of:
• Directlaserradiation
• Reectedlaserradiation
• Diffusedlaserradiation
WARNING! All the personnel present in the laser working area must wear
appropriate laser safety eyewear.
Use protective eyewear with either of the following specifications:
• I2100L2(EUR)@2100NM
• OD4(US)@2100NM
Always check the integrity and condition of safety eyewear.
Before wearing protective eyewear, be sure that the protective glass and frame are in
good condition.
The worst-case nominal ocular hazard distance (NOHD) for the H-30 laser system emitting
laser energy from a fiber is 0.5 m. During service operations, there is access to laser
energy emitting directly from the laser source, which raises the NOHD to 15 m.
Hazards
Electrical Hazards
• Onlyaqualiedservicetechnicianmayremovetheenclosurecovers.Removingthe
enclosures exposes personnel to potential electrical hazards.
• DonottouchareasmarkedHIGHVOLTAGE.Theseandsurroundingcomponentsof
the laser system contain charge voltages of up to 700 VDC.
• Donotoperatethelasersystemiftheoperatingroomoorisooded.
• Servicetechnicians,donotpoweronthelasersystemunlessallhighvoltageareas
are dry and not in danger of flooding.
• Inspectpowercordbeforeuse.Donotuseadamagedpowercordorapowercord
with a damaged or loose power plug.

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Cook Medical © 2012 1-18
Chapter 3
Safety
Other Hazards
• RISKOFFIRE—Donotpointthedistalendofthebertowardammablematerials
such as surgical drapes.
• RISKOFEXPLOSION—Donotoperatethelasersysteminthepresenceofammable
substances, including flammable anesthetics.
• RISKOFUNINTENDEDMOVEMENT—Therearwheelshaveadirectionallocktoallow
the laser to be easily rolled from room to room when the lock is engaged and easily
positioned within an OR when the lock is disengaged. The front wheels on the laser
can be locked in place with brakes to keep the laser from shifting during operation.
Interference with Other Devices
Electromagnetic fields from other irradiants in the area surrounding the laser system can
affect the laser’s performance. The laser’s electromagnetic field can also have an affect on
other electrical devices.
Do not use cellular phones in the immediate vicinity of the laser system.

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Chapter 4
Indications & Instructions for Use