COOK Medical H-30 User manual

USER MANUAL
MANUAL DEL USUARIO
MANUALE D’USO
Rhapsody® H-30®
HOLMIUM LASER SYSTEM

English .....................................................................................................................................................................................1-2
User manual
Español....................................................................................................................................................................................2-2
Manual del usuario
Français ...................................................................................................................................................................................3-2
Manuel d’utilisation
Language Index

1-2
Chapter 1: Introduction
About Cook Medical........................................................... 1-4
Device Description.................................................... 1-5 - 1-7
System Specifications........................................................ 1-8
Labels and Symbols............................................................ 1-9
Chapter 2: Indications
Indications ...........................................................................1-11
Indications for Use ............................................................1-11
Contraindications..............................................................1-11
Warnings and Precautions -
General..................................................................... 1-12 - 1-13
Warnings and Precautions -
Gynecological.....................................................................1-14
Warnings and Precautions -
Gastroenterological and Pulmonary..........................1-14
Chapter 3: Safety, Warnings, and Caution
General Warnings and Caution ....................................1-16
General Safety Information............................................1-16
Staff Training .......................................................... 1-17 - 1-16
Working Area ......................................................................1-17
Repair and Modifications of the Device....................1-17
Eye and Skin Exposure........................................ 1-17 - 1-18
Hazards .................................................................... 1-18 - 1-19
Safety Indicators ................................................................1-20
Interference with Other Devices..................................1-20
Chapter 4: Installation
Installation ...........................................................................1-22
Transportation....................................................................1-22
Unpacking the Laser System............................ 1-22 - 1-23
Cleaning................................................................................1-23
Contents ...............................................................................1-23
Ambient Operating Conditions....................................1-23
Filling the Cooling System with Water.......................1-24
Initial System Power-On..................................... 1-25 - 1-26
Verifying Alignment and Calibration............. 1-26 - 1-27
Electromagnetic Emission
and Interference ................................................... 1-27 - 1-29
Chapter 5: Operation
System Power-On..............................................................1-31
Checking the Optical Fibers ..........................................1-31
Laser Screens ......................................................................1-32
Main Screen............................................................ 1-32 - 1-33
Options Screen...................................................... 1-34 - 1-35
Parameter Determination ..............................................1-35
Setting the Pulse Width...................................................1-35
Adjusting the Energy per Pulse....................... 1-35 - 1-36
Laser Parameters .................................................. 1-36 - 1-37
Turning the System Off ...................................................1-37
Protection Against Unauthorized Use.......................1-37
Error Messages ...................................................... 1-37 - 1-38
Chapter 6: Maintenance
General Maintenance.......................................................1-40
Cleaning................................................................................1-40
Cooling Water Level..........................................................1-40
Power Cord .........................................................................1-40
Labels.....................................................................................1-41
Replacing the Blast Shield................................. 1-41 - 1-42
Troubleshooting ................................................................1-43
Error Messages ...................................................... 1-43 - 1-44
Chapter 7: Warranty Information
Warranty Statement .........................................................1-46
Table of Contents

Chapter 1
Introduction
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Cook Medical © 2019 1-4
Chapter 1
Introduction
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About Cook Medical
Choosing Cook Medical means choosing quality and innovation without compromise. To attain
the best results with the Rhapsody H-30 Holmium Laser System 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 Rhapsody H-30 Holmium Laser System.
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 USA
Phone: [phone]
www.cookmedical.com
Cook Capital Equipment Service and Repair Center
Phone: [phone]
capitalser[email protected]

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Chapter 1
Introduction
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Device Description
Name Laser Source
Rhapsody® H-30® Holmium Laser System Ho:YAG
Front of Laser
Figure 1
Emergency
Stop Button
Emission
Warning Indicator
Laser Aperture
Touch Screen

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

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Chapter 1
Introduction
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Device Connections
The Rhapsody H-30 Holmium Laser System contains one laser source, emitting at 2100 nm. The
laser is delivered through an optical fiber (holmium laser fiber) connected to the laser aperture.
(See Figure 1, page 1-5.)
Laser Aperture
The output laser beam is delivered through an optical fiber. To connect a fiber, lift the dust shield
by using the small lever located above the laser aperture. Then attach the fiber to the laser
aperture. The lever is magnetized and will stay in the open position once the dust shield is lifted.
(See Figure 1, page 1-5.)
Key Switch
The key switch turns the device on. There are two positions on the switch: (on) and
(off). To power on the device, insert the key and turn it clockwise to the“on”position. To power
off the device, turn the key to the“off”position and remove it. (See Figure 2, page 1-6.)
Emergency Stop Button
In case of an emergency, push the emergency stop button to immediately shut down the laser
system. To reset the emergency stop button, twist the button counterclockwise and pull it out.
(See Figure 1, page 1-5.)
Foot Switch
Plug the foot switch into the back panel of the laser system. When not in use, the foot switch can
be stored on the back panel.
MAINS Switch
The MAINS switch controls AC power into the laser system. (See Figure 3, page 1-6.) Setting this
switch to the“off”position disconnects the device from MAINS power.

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Introduction
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System Specifications
General Specifications
Electrical Requirements HL-30A: 115 V ~ ±10%/50-60 Hz/15 A (20 W output)
HL-30B: 115 V ~ ±10%/50-60 Hz/20 A (30 W output)
HL-30E: 230 V~ ±10%/50-60 Hz/10 A (30 W output)
Dimensions 20 in (W) x 23 in (D) x 51 in (H)
50 cm x 59 cm x 129 cm
Weight 225 lbs
102 kg
Temperature (operational) 50°F - 77°F,
10°C - 25°C
Temperature (storage) 41°F - 104°F,
5°C - 40°C
Relative Humidity From 30% to 85% (noncondensing conditions only)
Cooling Self-contained water-to-air heat exchanger
Electrical Protection Class I
Type of Applied Part BF (Note: Optical Fibers are Type BF Applied Parts)
Atmospheric Pressure 800-1060 hPa
Degree of Protection IPX0 (IEC529) Not protected from solids. Not protected from
liquids. IPX8 for foot pedal.
Laser Specifications
Laser Type Pulsed CTH:YAG (Ho:YAG)
Wavelength 2100 nm
Power to Tissue up to 30 W
Energy/Pulse 0.5 - 3.5 J
Divergence 0.44 rad ±5%
Application Mode Pulsed
Pulse Duration ~150 - 800 µs (short and long pulse - width modes)
Repetition Rate 5 - 20 Hz
Delivery Device Wide range of flexible silica fibers
Output Deviation
Accuracy: The device contains an internal measuring system
to control the actual emission of the laser energy. The device
does not require user calibration.
Deviation: The laser energy values can diverge from the
preset values by a maximum of 20%.
Aiming Beam Diode laser, green, 532 nm (adjustable < 5 mW)

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Introduction
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Labels and Symbols
VISIBLE AND INVISIBLE LASER RADIATION / RAYONNEMENT LASER VISIBLE ET INVISIBLE
RADIAZIONE LASER VISIBILE ED INVISIBILE
30 W
150 - 800 µs
2100 nm
Cod. DBM000316.01
Aiming beam
Classe 3R <5mW @ 532nm
Class 3R <5mW @ 532nm
Fascieau de visée
Luce Guida
Maximum Power / Puissance maximale / Massima potenza
Standard / Conformément à la norme / In accordo con la norma IEC/EN 60825-1: 2007
Pulse duration / Durée de l’impulsion / Durata impulso
Wavelength / Longueur d’onde / Lunghezza d’onda
Avoid eye or skin exposure to direct or scattered radiation. Class 4 laser product.
Eviter toute exposition des yeux ou de la peau aux rayons directs ou diffusés.
Appareil laser de Classe 4.
Evitare l’esposizione dell’occhio e della pelle alla radiazione diretta o diffusa.
Apparecchio laser di Classe 4.
Classe 3R <5mW @ 532nm
WARNING—Visible and
invisible laser radiation.
Emergency Stop
Remote InterLock Optical Fiber
Applicator
Foot switch
laser activation device
Not for general waste
Type BF applied part
Key Switch position

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Chapter 2
Indications

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Chapter 2
Indications
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Indications
This section discusses the use of the Rhapsody H-30 Holmium Laser System in clinical applications.
The information is provided by specialty and includes procedural recommendations, along with
specific indications and contraindications. The information provided in this section is not all-
inclusive and is not intended to replace physician training or experience.
Only physicians and staff who have been appropriately trained and who are thoroughly familiar
with the instructions and safety precautions provided in this manual should operate the system. A
review of prior training is strongly encouraged and recommended.
Indications for Use
The Rhapsody H-30 Holmium Laser System is intended for incision, excision, resection, ablation,
vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open
surgical, laparoscopic, percutaneous, or endoscopic procedures in urological, gynecological,
gastroenterological, or pulmonary applications.
Contraindications
The Rhapsody H-30 Holmium Laser System should only be used in conditions where its use
is appropriate and its efficacy has been proven. A qualified physician should perform clinical
applications.
The use of the Rhapsody H-30 Holmium Laser System is contraindicated for patients:
• Who are inappropriate candidates for laser surgery
• Where appropriate anesthesia is contraindicated by patient history
• Whose general medical condition contraindicates surgical intervention
• Where tissue (especially tumors) is calcified
• Requiring hemostasis of vessels over approximately two millimeters in diameter
• Where laser therapy is not considered the treatment of choice
• Where any irrigant other than physiological saline or sterile water is used
The use of the Rhapsody H-30 Holmium Laser System is contraindicated for the treatment of
menorrhagia in the following:
• Patients who desire future childbearing potential
• Patients who have any medical condition that contraindicates hysteroscopy, such as active
pelvic inflammatory disease
• Patients who have indications of precancerous pathology

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Indications
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Warnings and Precautions - General
The information in this section applies to all specialties for which the Rhapsody H-30 Holmium
Laser System is indicated.
The physician should become fully acquainted with the unique surgical and therapeutic effects
produced with the 2100 nm wavelength before using the Rhapsody H-30 Holmium Laser System
clinically. These effects may include coagulation, deep penetration, and intense cutting.
Unless otherwise stated in the specific application section, the physician should begin at the
lowest power and use shorter durations. The physician should note the surgical effect and adjust
the settings until the desired result is obtained.
Adverse events may result from deficiencies in operator skill level, or they may be due to a
concomitantly occurring primary procedure. Careful patient selection and adherence to the
manufacturer’s Instructions for Use will help to mitigate risk.
• Extreme caution should be used until the physician is completely familiar with the biological
interactions of the laser with various tissue types.
• Changes in the tissue texture and color are the best indicators of the laser’s effect. The
recommended power settings are less important than the observed effect on the tissue.
Specific pulse width should depend on the tissue and is left to the surgeon’s preference and
best medical judgment.
• Use the lowest possible power settings that are required in order to achieve the desired effect
on the tissue for treatment.
• Higher energy may be necessary to achieve the desired effect on the tissue if cooled irrigant is
used. Higher power settings may increase the chance of damage to the laser fiber.
• The use of mechanical pressure on the laser fiber does not increase its cutting or vaporization
effects but may induce bleeding, thermal damage, and fiber destruction.
• The risk of combustion, perforation, and laser-induced hemorrhage, any of which can cause
patient death, must be fully explained to the patient prior to surgery.
• Use caution with patients who have had difficulty with previous endoscopic or laparoscopic
procedures.
• The laser should be used only on a tissue target that is fully observable either by direct sight or
through an endoscope.
• Steady the distal end of the fiber at the intended treatment target before depressing the foot
switch.
• Vaporization or excision of anatomical structures in proximity to known critical structures, such
as large arteries, large veins, bowel, ureter, or bladder should be performed carefully to avoid
damage to such structures.
• Electrocautery should be easily accessible in case a bleeding artery or vein needs to be
cauterized.

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Indications
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• The flammability of methane gas must be considered when treating the perianal area.
• Tissue perforation can occur if excessive laser energy is applied, whether through excessive pulse energy or
extended laser application dwell time.
• Fiber tips are sharp; perforation may occur by mechanical means (poking).
• When risk of air embolism is present, such as when one is cutting or vaporizing organs with large vascular
structures, always use fluid cooling.
• Screen tumors that are in close proximity to known arteries or veins by pretreatment workups to precisely
locate the tumors.
• When radiotherapy and laser therapy are used concurrently, extra precautions should be taken, including
conducting more stringent postoperative monitoring. Patients who have undergone radiotherapy present a
greater risk of perforation and tissue erosion.
• Discontinue laser therapy immediately if the patient develops cardiopulmonary problems.
• Cook does not have clinical information about or experience with the use of the Rhapsody H-30 Holmium
Laser System on pregnant women or nursing mothers.
• Patients who have experienced discomfort during previous laser treatment may require analgesics.
• Anesthesia considerations: If the laser is used in an oxygen-rich environment (such as in endobronchial use),
oxygen concentrations should not exceed 21-30% in order to diminish the fire hazard. Endotracheal tubes
should be either non-combustible or wrapped with reflective tape.
• If the physician desires to use the delivery system without a contact probe or scalpel attached, the physician
must be aware of the increased risk of back-scatter and forward-scatter.
• Because of possible fluid absorption risks, patients with cardiovascular disorders should be carefully
evaluated as candidates for this procedure.
• When appropriate, moistened sponges should be placed on the tissues and instrumentation surrounding the
laser area to help dissipate incident laser energy and inadvertent heat production.
• Endoscopic treatment may result in adverse reactions such as stone migration, burns, hemorrhage,
laceration, infection, inflammation, pain, ureteral avulsion, air embolism, pneumothorax, or bladder, ureteral,
or bile duct perforation. In extreme cases, death may occur due to procedural complications, concurrent
illness, or the application of laser radiation.
• Adverse events reported in clinical literature in the context of holmium laser procedures include subcapsular
renal hematoma, bladder neck contracture, urethral stricture, residual adenoma, hematuria, dysuria, acute
urinary retention, urinary incontinence, bladder neck stenosis, difficult micturition, urethral or bladder injury,
ureteric orifice injury, hydronephrosis, steinstrasse, recatheterization, clot retention, acute epididymitis, septic
shock, hypoxemia, mucosal injury, pancreatitis, cholangitis, biliary stricture, and ascites.

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Indications
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Warnings and Precautions - Gynecological
• During intrauterine laser surgery, do not use gas or air for cooling the laser fiber tip or for
insufflation. This may cause life-threatening gas or air embolism.
• Patient monitoring: Special precautions should be taken to monitor the patient for fluid
absorption (from hysteroscopic distention media). Excessive fluid absorption is worrisome
if the procedure is prolonged. During the procedure venous channels seem to be open, but
bleeding is controlled by the pressure of the irrigating solution. There is a large raw surface,
and a large volume of fluid may be absorbed. Wider dilation of the cervix to allow irrigating
fluid to flow more freely around the hysteroscope and reduce intrauterine pressure may reduce
the risk. If excessive fluid is absorbed, appropriate therapy such as diuretic administration
should be considered with subsequent electrolyte monitoring.
• Consideration should be given to closing the fallopian tubes prior to an intrauterine procedure
to treat menorrhagia. However, if the physician, after consultation with the patient, determines
that sterilization is not indicated, the patient must be advised to utilize a contraceptive
technique to avoid pregnancy. Although pregnancy is highly unlikely after this type of
procedure, there is no data regarding the potential risks should pregnancy occur.
• Patients are urged to have a pap smear annually. There is a possibility that in the very small
percentage of women who develop uterine cancer, their symptoms of bleeding may be hidden
as a result of this treatment. While other symptoms would still be expected to occur (pain,
other discharges, etc.), a pap smear should be performed to reveal any possible cancerous
development.
• Due to the etiology of the disease, laser treatment of endometriosis and peritoneal adhesions
may result in only temporary improvement. A recurrence of the disease may require
retreatment.
• Distention of the uterine cavity is at the discretion of the operating hysteroscopist. The
recommended distention media for laser hysteroscopy is normal saline (0.9% sodium chloride).
Warnings and Precautions - Gastroenterological and Pulmonary
• “Flash” fire can occur during pulmonary procedures. Do not use general inhalation anesthetics.
Oxygen levels in the procedure room must not be higher than 30%.
• Use caution with patients who have had previous esophageal or tracheal fistulae or episodes
of aspiration.
• After esophageal procedures, swallowing may be paradoxically worsened rather than
immediately improved. This is caused by secondary tissue edema. This potential problem
should be explained to the patient prior to surgery.
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Chapter 3
Safety, Warnings, and Caution

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Chapter 3
Safety, Warnings, and Caution
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General Warnings and Caution
The Rhapsody H-30 is a holmium laser system, with up to 30 W, for surgical procedures. The
device is manufactured in accordance with Annex II of the 93/42/EEC standard and is identified as
follows:
Device 30 W Holmium Laser System
Name Rhapsody® H-30® Holmium Laser System
Models HL-30A (20 W), HL-30B, HL-30E
Device Category Laser for medical use
Device Classification II b (according to 93/42/EEC)
Laser Classification IV
Manufactured By Cook Incorporated
750 Daniels Way
Bloomington, IN 47404, USA
Phone: [phone]
www.cookmedical.com
General Safety Information
• This manual contains important information about the safe use of the laser system.
• All persons who operate the laser system must understand the operating and safety
instructions specified in this manual (IFU).
• Only authorized individuals with appropriate medical laser training and knowledge should
operate the laser system.
• Only authorized individuals with appropriate laser training and knowledge should service the
laser system.
• Only authorized service personnel should access the internal electrical or optical components.
• The laser system must be completely closed and assembled for normal operation. Only
trained, authorized personnel are allowed to open the external covering panels.
• Access to the user manual should be available in the working area of the laser system.
• All of the warning labels must be kept in good condition.
DO NOT dispose of this product with residential waste. Disposal of this device should
be in accordance with applicable local, regional, and national laws and regulations.
This device cannot be disposed of as municipal waste, but must be separated in
accordance with the WEEE (Waste Electrical and Electronic Equipment) Directive.
Staff Training
The use of the laser system is restricted to medical staff who have received proper training in laser

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Safety, Warnings, and Caution
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safety, operation of the Rhapsody H-30 Holmium Laser System, and the identification and use of
appropriate personal protective equipment.
Working Area
This Rhapsody H-30 Holmium Laser System is a class 4 laser and must be used in a specific
nominal hazard zone (NHZ) or working area that is defined and delimited in accordance with all
applicable local and international standards (IEC60825-1:2007, ANSI Z136.3). In general clinical
operation, the working area is typically defined as the operating room.
Repair and Modifications of the Device
Only authorized service personnel should perform repairs and maintenance. Constructive
modifications are not permitted.
NOTE: Unauthorized repair, maintenance, and/or modifications to the laser system will void the
warranty.
WARNING! Performing any procedures, operating any controls, or making any adjust-
ments other than those specified herein may result in hazardous radiation exposure.
CAUTION: The use of controls or adjustments or the performance of procedures other than those
specified herein may result in hazardous radiation exposure.
Eye and Skin Exposure
The working laser beam of the Rhapsody H-30 Holmium Laser System is invisible and, if exposed
to the eyes, may cause sight loss. The skin can resist a significantly higher amount of laser energy
than the eyes, but the laser beam can also seriously burn the skin.
A danger exists in any case of:
• Direct laser radiation
• Reflected laser radiation
• Diffused laser radiation
WARNING! All personnel present in the laser working area must wear
appropriate laser safety eyewear.
WARNING! Incorrectly inserting the fiberoptics, sharply bending or improperly secur-
ing the fiberoptics, or failing to follow the fiberoptics installation procedure may lead
to damage to the fiber or delivery system and may result in harm to the patient or
operator.
Use protective eyewear with either of the following specifications:
• I 2100 L2 (EUR) @ 2100NM
• OD 4 (US) @ 2100NM

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Safety, Warnings, and Caution
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Always check the integrity and condition of protective 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 Rhapsody H-30 Holmium Laser
System emitting laser energy from a fiber is 0.5 m, and corresponding maximum permissible
exposure (MPE) for Holmium laser is 0.1 W·cm-². During service operations, there is access to laser
energy emitted directly from the laser source, which raises the NOHD to 15 m.
Hazards
Optical Hazard
The Rhapsody H-30 Holmium Laser System generates laser light at a wavelength of
2,100 nm, with a maximum energy of approximately 3.5 J, delivered from the optical fiber. Greater
energies can be generated from the laser resonator, especially during service operations. At the
Rhapsody H-30 Holmium Laser System’s wavelength and operational energy levels, serious and
permanent eye damage can occur when there is direct or indirect optical exposure.
The laser beam emitted by this laser system can cause vision loss. Laser energy transmitted by
this laser that enters the eye can cause a corneal burn or can be focused on the retina. Direct
absorption of laser energy by the retina can result in temporarily clouded vision, retinal lesion,
long-term scotoma, or long-term photophobia.
Danger exists from any of the following:
• Direct laser radiation
• Reflected laser radiation
• Diffused laser radiation
Electrical Hazards
• Only a qualified 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 the surrounding components of the
laser system contain charge voltages of up to 700 VDC.
• Do not operate the laser system if the floor is flooded.
• Service technicians should not power on the laser system unless all high-voltage areas are dry
and not in danger of flooding.
• Inspect the power cord before use. Do not use a damaged power cord or a power cord with a
damaged or loose power plug.
Fire/Explosion Hazard
The Rhapsody H-30 Holmium Laser System has the ability to melt, burn, or vaporize almost any
material. A fire can also occur because of the nature of the laser radiation. Precautions should
be taken when alcohol, gasoline, drapes, or any other ignitable materials are in or around the
working area. Keep a fire extinguisher in close proximity to the laser system.

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Safety, Warnings, and Caution
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NOTE: In a clinical environment, consider using sterile water to extinguish any fire caused by laser
radiation.
WARNING! High temperatures produced during the normal use of the laser system
may ignite some materials (e.g., cotton wool when saturated with oxygen), or endog-
enous gas. Solvents of adhesives and flammable solutions used for cleaning and
disinfecting should be allowed to evaporate before the laser system is used.
Fire/Explosion Hazard Precautions:
• Keep only a minimum amount of any combustible materials (e.g., alcohol) in the service room.
If possible, stock combustible materials away from the working area while you are servicing the
laser system.
• Always keep a fire extinguisher and/or cool water in the immediate area.
• Never direct the laser beam onto any surface except a power meter or an appropriate beam
dump or heat sink.
NOTE: Water acts as an excellent heat sink for the Rhapsody H-30 Holmium Laser System’s laser
radiation, especially when the distal end of the fiber is immersed.
Laser-Generated Airborne Contaminants (LGAC)
The smoke plume created by laser contact with various materials can create toxic gases and
vapors. If the target material is tissue, then both dead and live cellular material, including viable
viruses, may be present. The potential hazardous area for LGAC exposures may often exceed the
working area.
CAUTION: Laser fume and/or plume may contain viable tissue particulates.
LGAC Precautions
Use respiratory protection or ventilation (such as high-quality, well-filtered smoke evacuators) to
control LGAC whenever laser radiation might generate plumes.
NOTE: Surgical masks do not protect against LGAC.
Other Hazards
• RISK OF FLUID INGRESS—This product is rated as IPX0 and does not protect against ingress of
fluids. For cleaning, apply a cleaning agent to a cloth and wipe the external case. Do not pour
or spray liquids directly onto the device. Do not operate the device if it has become wet.
• RISK OF FIRE—Do not point the distal end of the fiber toward flammable materials such as
surgical drapes.
• RISK OF EXPLOSION—Do not operate the laser system in the presence of flammable
substances, including flammable anesthetics.
• RISK OF UNINTENDED MOVEMENT—All four wheels on the laser system have non-directional
locks, meaning they can be locked in any position, thus preventing unintended movement of