COOLGLIDE FAMILY OF Nd:YAG OPERATOR MANUAL LASER

Transcription

i
COOLGLIDE® FAMILY OF Nd:YAG
LASER SYSTEMS
OPERATOR MANUAL
COOLGLIDE FAMILY OF ND:YAG LASER SYSTEMS
D0237, REV. C, 6/14
ii
This manual is copyrighted with all rights reserved. Under copy right laws, this
manual may not be copied in whole or in part or reproduced in any other media without the
express written permission of Cutera, Inc. Permitted copies must carry the same proprietary
and copyright notices as were affixed to the original. Under the law, copying includes translations into another language.
Please note that while every effort has been made to ensure that the data given in this document
is accurate, the information, figures, illustrations, tables, specfications, and schematics contained herein are subject to change without notice.
Cutera is the registered trademark of Cutera, Inc.
©June 2014 Cutera, Inc.
Published in USA
D0237
Revision C
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
GMDN: 35940
UMDN: 17-775
D0237, REV. C, 6/14
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Contents
Introduction 1
Oveview 1
Operator Training 3
Indications for Use 3
Contraindications for Use 4
Precautions 4
Safety and Regulatory 5
Optical Hazard 5
Electrical Hazard 7
Fire Hazard 7
Regulatory Compliance 8
Locations of Controls 8
Key Switch 8
Emergency Off Push-Button 8
Laser Emission Indicator 8
Door Interlock 9
Protective Housing 9
Laser Safety Shutter 9
Audible Emission Indicator 9
Manual Reset 9
Electromagnetic Compatibility 10
Operational Safety 15
Location of Regulatory Compliance Labels 17
Site Preparation 19
Requirements 19
Unpacking 20
Installation 20
Remote Interlock 20
Treatment Room Safety 21
System Description 23
Console 23
ClearView Handpiece 25
D0237, REV. C, 6/14
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Control Panel/Buttons 28
System Specifications 33
System Operation 37
System Startup 37
System Use 38
System Shut Down 42
Clinical Application 43
Indications for Use 43
Contraindications for Use 44
Precautions 44
Expected Transient Events and Possible Adverse Effects 45
Patient Information 46
Treatment Information for Vascular Lesions, Hair Removal and Non-Ablative Procedures 46
Maintenance 47
Troubleshooting Guide 47
User Maintenance 51
Cleaning the External Surfaces of the System Console 51
Cleaning the Handpiece Window 51
Replacing the Handpiece Window 54
Disinfecting the Handpiece Tip 55
Cleaning the External Surfaces of the Handpiece 55
Inspecting and Cleaning the Heat Exchanger Intake 56
Fill Coolant 57
Facility Requirements 60
Calibration Procedure 60
Equipment Required 61
Calibration Instructions 61
End of Life Disposal - Environmental Information 62
Warranty Information 62
Appendix A - Laser Warning Sign
Appendix B - Symbols
Appendix C - Bibliography
Appendix D - Error Code Guide
Appendix E - Cutera Direct Office Locations
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1
Introduction
Overview
The family of CoolGlide® laser systems includes the CoolGlide with
a fixed 10mm spot size, the CoolGlide Excel, the CoolGlide Vantage
and the Genesis laser systems with a variable spot size of 3, 5, 7 or
10mm. The family of CoolGlide laser systems delivers high power,
long-pulse 1064nm energy. Fluence, pulse width, spot size and repetition rate are adjustable over the ranges identified in the product
specification. The practitioner places the handpiece on the skin of the
patient to deliver laser energy to the treatment site. In addition to
delivering the laser energy, the handpiece also serves to locally cool
the skin of the patient prior to and/or after each light pulse by contact
cooling. The cooling device is integrated into the handpiece.
Console (Front)
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Laser output parameters are selected using the control panel located on the top of the console.
Selectable parameters include fluence, pulse width, repetition rate, Standby/Ready and the spot
size on the Excel Handpiece. See System Specifications section for additional information
.
Handpiece
The Clearview handpiece, which is placed against the skin of the patient serves two purposes:
• Delivers the laser energy to the treatment area.
• Cools the epidermis at the location of prior and/or subsequent laser energy delivery.
The CoolGlide Excel spot size selector is located on the handpiece. See the System Specifications section for additional information.
CoolGlide Excel Handpiece
The laser system is designed to be safe when used by and under the supervision of trained professionals. The laser radiation emitted from the laser system can be harmful if proper procedures are not followed.
NOTE
While the procedures outlined in this manual should be followed
carefully, steps that are critical for safety with the system will indicated by CAUTION.
Steps that are critical for proper use of the system, or present a
potential safety hazard, will be indicated by WARNING.
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Operator Training
CAUTION
Federal law restricts the sale of this device to or by the order of a
licensed practitioner licensed by the law of the state in which he
practices to use or order the use of the device; and the method of its
application or use.
Do not attempt to use this system until you have been properly
trained on system operation by certified personnel and have read
this manual thoroughly.
In addition to laser safety training of personnel, the user should consider adopting a training
and safety program as outlined by the latest ANSI Standard Z-136.3, the American National
Standard for the Safe Use of Lasers in Health Care Facilities. The practitioner should also
keep current with all relevant medical literature.
Indications for Use
The family of CoolGlide laser systems is intended for use in aesthetic and surgical applications
requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology.
• For removal of unwanted hair.
• For stable long-term, or permanent hair reduction through selective targeting of
melanin in hair follicles.
• For treatment of pseudofolliculitis barbae (PFB).
• For use on all skin types (Fitzpatrick I-VI), including tanned skin.
• For coagulation and hemostasis of benign vascular lesions such as, but not limited
to, hemangioma, port wine stains, telangiectasias, rosacea, venous lakes, leg veins,
spider veins and poikiloderma of Civatte.
• For treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
• For the reduction of red pigmentation in hypertrophic scars where vascularity is an
integral part of the scar.
• For treatment of warts.
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Contraindications for Use
Contraindications for use include those patients who:
• Pregnant patients
• Patients undergoing treatment for skin cancer
Precautions
• Photosensitizing drugs (Tetracyclines, etc.)
Be aware that you may have to adjust the treatment parameters according to
clinical response from test area(s).
• Anticoagulants
May increase risk of purpura or bruising
• History of coagulpathies
• History of keloids or hypertropic scarring
• Diabetes
May impede wound healing
• History of herpes
Pre-treatment with an antiviral may be indicated
• Accutane use
• History of vitiligo
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Safety and Regulatory
The family of CoolGlide laser systems, when properly used by trained personnel, is a safe and
effective instrument for the indicated clinical treatments. The system contains many safety features; however, safe operation requires a thorough understanding of the system and safety features as described in this Operator Manual.
Optical Hazard
The CoolGlide laser system is a Class IV Laser Product as defined by the U.S. Code of Federal
Regulations and a Class 4 Laser as defined by IEC 60825-1.
WARNING
The laser light produced by this system is an invisible infrared
(1064nm) light that can cause permanent eye damage. Never look
directly into the handpiece even when wearing protective eyewear.
Never look directly into the laser beam or at scattered light from
metallic or other reflective surfaces. Both direct and reflected laser
light may contain sufficient energy to cause permanent eye damage.
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All personnel operating the family of CoolGlide laser systems or in the vicinity of the laser,
including the patient, staff personnel or observers, should wear protective eyewear with sufficient protection (optical density specified or greater in System Specifications) at the wavelength of 1064nm. The eyewear should have guards on both sides to protect the eyes from
lateral exposure.
WARNING
Never allow anyone near the laser while in use, without proper protective eyewear.
Guidelines and information on the safe use of lasers, and the safe use of lasers/laser systems in
a diagnostic and therapeutic areas, can be found in the following:
• The American National Standard for the Safe Use of lasers in Health Care Facilities (ANSI Z136.3-2005).
• The American National Standard for Safe Use of Lasers (ANSI Z136.1-2007) provide guidance for the safe use of lasers and laser systems in diagnostic and therapeutic areas.
• IEC 60825-1:2014, Annex A.
The above standards describe the following terms in the description of laser hazards:
• Maximum Permissible Exposure (MPE) - The highest level of laser radiation to
which a person may be exposed without hazardous effect or adverse biological
changes in the eye or skin.
• Nominal Ocular Hazard Distance (NOHD) - The distance along the axis of the
unobstructed beam beyond which exposure during normal operation is not expected
to exceed the appropriate MPE. This distance is measured from the laser aperture.
• Nominal Hazard Zone (NHZ) - The space within which the exposure level during
normal operation exceeds the applicable MPE. The outer limit of the NHZ is the
NOHD.
For specific values, see Eye Safety in the System Specifications section of this manual.
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Electrical Hazard
• High Voltages are present inside the system. Do not remove the exterior housing.
• Only an authorized Cutera Service Representative should perform the service on
the system.
• Do not attempt to perform maintenance other than that which is outlined in this
manual.
• Maintenance should only be performed with the system turned off and disconnected from the power source.
• The system is grounded through the grounding conductor in the power cable.
Grounding is essential for safe operation.
Fire Hazard
WARNING
Do not use this system in the presence of flammable materials,
solutions, or gases or in an oxygen-enriched environment. An
explosion and/or fire could occur.
WARNING
The high temperatures produced in normal use of the system may
ignite endogenous gases, as well as some materials (e.g., cotton
wool when saturated with oxygen). The solvents of adhesives and
flammable solutions used for cleaning and disinfecting should be
allowed to evaporate before the system is used.
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Regulatory Compliance
All Cutera aesthetic platforms are designed to comply with the following:
• US Federal Performing Standards 21 CFR 1040.10 and 1040.11, IEC 60601-1, IEC
60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22 and IEC 60825-1
• 21 CFR Chapter I, Subchapter J, as administered by the Center for Device and
Radiological Health of the US Food and Drug Administration (FDA)
Location of Controls
Controls are located on the control panel on top of the system console, on the handpiece, and
on the footswitch. In each case, they are positioned so that the operator can access them without being exposed to the laser beam.
Key Switch
To prevent unauthorized use, the laser can only be turned on with the proper key. The key cannot be removed while in the ON (or START) position and the laser will only operate with the
key in place. When treatments are complete or the system is not is use, always remove the key.
Emergency Off Push-Button
The laser system can be immediately shut down, terminating laser emission by pushing the red,
mushroom-shaped button that is located in the upper left hand corner of the control panel. Following emergency shutoff, the keyswitch must be used to restart the system.
Laser Emission Indicator
When the laser system is in the READY mode, the READY indicator illuminates, providing a
visible warning that the system is ready to emit laser energy when the footswitch is depressed.
To allow the operator to avoid unintentional laser exposure, the READY indicator illuminates
and flashes for approximately three seconds before the system is capable of emission.
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Door Interlock
The door interlock connector on the back panel, when used in conjunction with a remote
switch connected to the treatment room door, will disable the laser system when the treatment
room door is opened.
Protective Housing
The laser system has a protective housing that prevents unintended human access to laser radiation above Class I limits. The housing must only be opened by a Cutera-certified representative.
No section of the protective laser system housing can be opened without special tools.
Laser Safety Shutter
The laser system contains a “normally closed” safety shutter that prevents laser emission when
in the closed position. The shutter is opened only when the system is in the READY mode.
Audible Emission Indicator
Each laser pulse delivered is accompanied by an audible beep. In addition, when the CoolGlide Vantage and the Genesis laser systems are operated at a repetition rate of 4 Hz or greater,
a distinctive “water drop” sound is emitted each time the pulse counter reaches a count that
ends in “00” in order to indicate the delivery of 100 shots.
Manual Reset
If the system shuts down during operation (due to electrical power loss, depression of the
EMERGENCY OFF button, or opening of the Door Interlock switch), the system must be
manually restarted using the key switch to resume operation. The system’s internal memory
will recall the most recent operating parameters upon restart.
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Electromagnetic Compatibility
Like other electrical medical equipment, the family of CoolGlide laser systems requires special
precautions to ensure electromagnetic compatibility (EMC) with other electrical medical
devices. To ensure electromagnetic compatibility, the family of CoolGlide laser systems must
be installed and operated according to the EMC information provided in this manual.
WARNING
Do not use cables or accessories other than those provided with
your CoolGlide system or compatible handpieces, as this may result
in increased electromagnetic emissions or decreased immunity to
such emissions.
WARNING
If the CoolGlide system is used adjacent to or stacked with other
equipment, observe and verify normal operation of the system in
the configuration in which it will be used prior to using it in a surgical procedure. Consult the tables below for guidance in placing
the CoolGlide system.
CAUTION
Portable and mobile RF communications equipment may affect the
normal function of the CoolGlide system.
NOTE
The family of CoolGlide laser systems complies with IEC 60601-12 (Edition 3) requirements for EMC with other devices.
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Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The family of CoolGlide laser systems is intended for use in the electromagnetic environment specified below. The
customer or the user of the CoolGlide system should ensure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic Environment: Guidance
RF emissions CISPR 11
Group 1
CoolGlide systems use RF energy only for
internal function; therefore, RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC61000-3-2
Class A
Voltage Fluctuations/flicker emissions
IEC61000-3-3
Complies
CoolGlide systems are suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low voltage power supply
network that supplies buildings used for
domestic purposes.
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Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electrostatic
Discharge (ESD)
±6kV contact
±2, 4, 6kV contact
±8kV air
±2, 4, 8kV air
Floor should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
±2kV for power supply
lines
±2kV line to ground
IEC61000-4-4
±1kV for input/output
lines
Surge
±1kV differential mode
±0.5, 1kV
IEC61000-4-5
±2kV common mode
differential mode
IEC61000-4-2
Mains power quality should be that of a
typical commercial or hospital environment.
±1kV line to line
±0.5, 1, 2kV
common mode
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
Power frequency
(50/60Hz) magnetic
field
<5% Ut (>95% dip in
Ut) for 0.5 cycle
<5% Ut (95% dip in
Ut) for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95% dip in
Ut) for 5 sec.
<5% Ut (>95% dip in
Ut) for 5 sec.
3 A/m
N/A
IEC 61000-4-8
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
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If the user of the CoolGlide system requires
continued operation during power mains
interruptions, it is recommended that the
CoolGlide system be powered from an
uninterruptible power supply or a battery.
Power-frequency magnetic fields should be
at levels characteristics of a typical location
in a typical commercial or hospital
environment.
13
Guidance and Manufacturer’s Declaration: Electromagnetic immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Portable and mobile RF communications
equipment should be used no closer to any part of
the CoolGlide system, including its cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150kHz to 80 MHz
Radiated RF
IEC 61000-4-3
3V/m
80MHz to 2.5 GHz
3V
3 V/m
Recommended Separation Distance
d = 1.17 √P
d = 1.17 √P 80MHz to 800MHz
d = 2.33 √P 800MHz to 2.5GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey(a),
should be less than the compliance level in each
frequency range(b).
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE: 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobiles
radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered,. If the measured field strength in the location in which the CoolGlide system is used exceeds the applicable
RF compliance level above, the CoolGlide system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the CoolGlide system.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
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Recommended Separation Distances Between Portable and Mobile RF Communications Equipment
and the CoolGlide System
The family of CoolGlide laser systems is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the CoolGlide system can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
CoolGlide system as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power (W) of transmitter
Separation distance (m) according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.17 √P
d = 1.17 √P
d= 2.33 √P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.70
3.70
7.37
100
11.70
11.70
23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
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Operational Safety
WARNING
Laser plume obscures the operative field and is noxious to those
who come in contact with it. The plume presents a possible pollution hazard and should be effectively evacuated.
CAUTION
Prior to each use of the system, inspect all protective eyewear,
cables and the handpiece for any damage, excessive wear, or crimping that could affect system performance or safe operation.
CAUTION
Do not place any unnecessary stress on the umbilical cable (i.e., by
pulling on it, tightly bending it or twisting the handpiece). See System Specifications section for additional information on minimum
bend radius.
NOTE
The recessed laser aperture window and pre-cooling tip should be
kept clean during and prior to each treatment procedure. See the
Maintenance and Troubleshooting section for recommended cleaning and disinfecting procedures.
WARNING
Do not allow untrained or unqualified personnel to use the laser
system at any time.
CAUTION
Always verify that the treatment parameters are correct before activating the laser.
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CAUTION
Before placing the system in READY mode, confirm that the laser
handpiece aperture is safely positioned to prevent unintended laser
exposure.
CAUTION
The laser should always be OFF or in the STANDBY mode until
the handpiece is safely positioned at the area to be treated.
WARNING
Never point the laser at reflective objects, such as jewelry or
smooth metal surfaces.
WARNING
Never activate the laser while pointing the laser into free space.
WARNING
Do not leave the system in READY mode when not in use. Always
place the system in the STANDBY mode or turn the system OFF
and remove the key when not performing treatments.
WARNING
Do not leave the system unattended with the key in place.
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Location of Regulatory Compliance Labels
As required by national and international regulatory agencies, appropriate regulatory compliance labels have been mounted in specified locations. All treatment room staff should be familiar with the location and meaning of these labels.
Regulatory compliance labels
(Refer to the following page for
label illustrations for all models.
Refer to Appendix B for symbol
descriptions.)
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REF : xxxxxxxx
SN : Xyyyyy
Mmmmm Yyyy
Brisbane, CA
Xxx-xxx V~, xx A, xx Hz
This product is covered
by one or more of the
following U.S. and
corresponding foreign
patents and patent
applications:
6,383,176
6,485,484
6,569,155
5,595,568, 5,735,844
and 5,824,023
EC
REP
MDSS GmbH
Schiﬀgraben 41, D-30175
Hannover, Germany
INVISIBLE
–
INVISIBLE LASER
LASER RADIATION
RADIATION –
AVOID
AVOID EYE
EYE OR
OR SKIN
SKIN EXPOSURE
EXPOSURE TO
TO
DIRECT
OR
SCATTERED
RADIATION
DIRECT OR SCATTERED RADIATION
Output:
Output: ≤≤ 100J
100J Max
Max at
at 1064nm
1064nm
Duration:
ms
Duration: 0.1-300
0.1-300ms
Class
Class 44 LASER
LASER PRODUCT
PRODUCT
Per
Per IEC
IEC 60825-1:2007
60825-1:2014
Complies
Complieswith
with21
21CFR
CFR1040.10
1040.10 and
and 1040.11
1040.11
except
except for
for deviations
deviations pursuant
pursuant to
to Laser
Laser
Notice
No.
50,
dated
June
24,
Notice No. 50, dated June 24, 2007
2007
C u te ra , In c., 3 2 4 0 B a ysh o re B lvd ., B risb a n e C A 9 4 0 0 5
Certification
label
CoolGlide, CoolGlide Excel, CoolGlide Vantage and Genesis Identification Label
Non-interlock Housing Label
Located at lower corner on each
side of console
Emergency Stop Button
Located on top of console
(next to red button)
System OFF
Located next to
keyswitch
Momentary Start
Located next to
keyswitch
System ON
Located next to
keyswitch
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Site Preparation
Requirements
The family of CoolGlide laser systems is designed to require minimal site preparation. The following are specific electrical and space requirements:
• Electrical Requirements
The laser system is available in multiple configurations for a wide range of
power line voltages. The voltage and current requirements are clearly
marked on the panel label located on the back of the console. See System
Specifications section for specific information on voltage requirements.
CAUTION
Before connecting the system to electrical service, it is important to
verify that the system has been configured for the voltage and current of the available outlet. Damage to the equipment can occur if
the incorrect service is connected.
• Floor Space
The laser system must have adequate ventilation to operate properly. Air
must flow freely without obstruction from the rear panel. There should be at
least an 8-inch clearance from the rear of the system to the nearest wall or
vertical surface. See System Specifications section for footprint information.
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• Environmental Requirements
Appropriate environmental conditions must be present for proper operation.
See System Specifications for appropriate environmental conditions.
Unpacking
Inspect the crate for any external damage. If external damage to the crate is visible, contact
your local Cutera representative (see Appendix E). If no external damage is visible, proceed
with unpacking the laser system.
After inspection, unpack the laser system, inspecting each component for any indication of
damage that may have occurred during shipment. Make certain the contents match the checklist enclosed in the shipping crate. If any components are damaged or missing, please contact
your local Cutera representative immediately for assistance (see Appendix E).
Installation
Installation of the laser system is to be performed by an authorized Cutera representative.
Remote Interlock
A remote interlock connection is located on the back of the laser console. At
the option of the purchaser/user, the jumper can be removed and a customerprovided door-switch cable can be connected (this will shut the laser down
when the treatment room door is opened during system operation). The treatment room door must be closed in order to resume treatments. The laser system must be powered ON and allowed to complete the power-on sequence.
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Treatment Room Safety
• The entrance to the treatment room including the treatment room itself, must be
clearly labeled with signs indicating that the laser is being used. See Appendix A for
a sample of the appropriate treatment room label.
• The warning sign provided with the laser system should be placed on the door outside the treatment room
• Treatment room door should remain closed during treatment to prevent laser light
from escaping the treatment room.
• If the user desires, a door switch may connected to the laser so that the laser will
shut down if the treatment room door is opened.
• All treatment room windows should be covered with materials of sufficient optical
density to prevent laser light from escaping the treatment room.
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System Description
The family of CoolGlide laser systems consists of four major components:
• Console
• Clearview Handpiece
• Control Panel
• Footswitch
Console
The system console (shown below) consists of the following:
• Console Housing - Houses the main components and protects personnel from unintended exposure to laser radiation.
• Control Panel - Location or user controls where individual treatment parameters
such as fluence, pulse width and repetition rate can be selected. See Control Panel/
Buttons section for additional information.
• Handpiece Storage Receptacle - Conveniently and safely stores the handpiece
when not in use.
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• Console (rear) - Location of the power cord socket, main power circuit breaker,
footswitch socket, remote interlock and de-ionized water fill port.
• Casters - Durable, locking casters allows the system to be moved or locked into
place.
Console (Rear)
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Console (Side)
Console (Front)
25
ClearView Handpiece
The ultra-light handpiece is ergonomically designed to fit comfortably in the user’s hand and
provides a clear and unobstructed view of the treatment area. The symmetrical design is comfortable for both left and right-handed users. The handpiece serves two purposes; it delivers
laser energy to the treatment area and cools the epidermis. The incorporated treatment guides,
located at the distal end of the contact cooling surface, indicate current treatment beam location and allows for easy and effortless placement of subsequent treatment beams. The CoolGlide Excel, CoolGlide Vantage and the Genesis laser system incorporate an aiming beam to
indicate the treatment area. The size of the laser treatment beam (CoolGlide Excel, CoolGlide
Vantage and the Genesis laser systems only) is controlled using the spot size control on the
handpiece. Laser energy is delivered by depressing the footswitch. See Control Panel/Buttons
section for more information on delivering laser energy. Refer to System Specifications section
for additional system information
The laser system is designed to be safe when used by and under the supervision of trained professional. The laser radiation emitted from the laser system can be harmful if proper procedures are not followed.
CAUTION
Do not drop the handpiece as damage may occur. When not in use,
place the handpiece in the storage receptacle. The system should be
placed in STANDBY mode or the console should be OFF before
the handpiece is stored in the storage receptacle.
WARNING
In the ready MODE, depressing the footswitch will activate the
laser. Place the system in STANDBY mode or turn the system OFF
when not in use and place the handpiece in the storage receptacle.
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• Umbilical Cable - The umbilical cable connects the lase console to the handpiece.
It contains a fiber optic cable, cooling hoses and electrical cables that are permanently secured to both the laser and the handpiece and therefore, cannot be disconnected. The umbilical cable employs a rugged steel conduit that protects the fiber
optic cable and other components inside.
CAUTION
The umbilical cable should not be kinked or otherwise bent in a
tight radius. See System Specifications section for minimum bend
radius (storage and momentary). Do not stress or twist the umbilical
cable at the handpiece or console connections. Do not pull the console by the umbilical cable. Do not run over the umbilical cable
with heavy objects or step on the cable. Improper care or use may
cause damage to the umbilical cable or laser system.
• Laser Aperture - Near the distal end of the handpiece is the recessed laser aperture. A window protects the optical components inside the handpiece from damage
and contamination. Should this window become damaged or permanently contaminated, it should be replaced. Although replacement is not difficult, it should be
done only by a person properly trained on the procedure.
WARNING
Severe eye damage may occur if the footswitch is depressed while
the system is in READY mode and the aperture is directed toward
an unprotected eye. Make certain that the system is in the READY
mode only when treatment is to begin and the distal end of the
handpiece is in contact with the treatment location.
CAUTION
It is important to keep the recessed laser aperture clean and free of
debris. Damage to the window may occur if the treatment beam
strikes the debris. See Maintenance and Troubleshooting section for
proper cleaning procedures.
D0237, REV. C, 6/14
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• Chilled Contact Surface - At the distal end of the handpiece is the chilled contact
surface with treatment guides. This chilled contact surface is used to cool the epidermis prior to and/or after delivering a laser pulse and to protect the epidermis
from thermal injury. The chilled contact surface should be placed on and in contact
with the treatment location prior to and/or after (depending on the application) laser
activation. See Clinical Application section for instructions on proper use o the
handpiece.
NOTE
Condensation on the chilled contact surface is normal and need
not be wiped off. See Maintenance and Troubleshooting section
for proper cleaning procedures.
• Treatment Guide - The treatment guides, extending from the contact cooling surface, indicate the location of the current beam placement and provide easy and
accurate for subsequent beam placements. The CoolGlide Excel, CoolGlide Vantage and the Genesis laser include an aiming beam which indicates the location of
the current beam placement for treatment.
Treatment Guides
• Footswitch - The footswitch offers convenient and safe activation of the treatment
beam. The footswitch is waterproof as per IP68 regulation and connects at the designated port location at the back of the system console.
D0237, REV. C, 6/14
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WARNING
When the system is in the READY mode, pressure on the
footswitch will cause the laser energy to be emitted from the handpiece, which could cause unintended laser exposure and injury.
Place the system in STANDBY mode or turn the system OFF when
not in use.
Control Panel/Buttons
Control Panel Overlay Vantage, CoolGlide, Excel and Genesis Systems
Emergency Off - The EMERGENCY OFF button disconnects power
from the laser system and shuts the laser down.
Keyswitch - A keyswitch is provided to ensure that the system is used
only by authorized personnel. The key is removable only when in the
OFF position. Once removed, the laser is no longer operable. The key
switch is a three-stage switch with a separate OFF, ON and START
position. The key is turned to the START position for approximately
three seconds. Once released, the key will return to the ON position
automatically.
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Fluence Indicator and Controls - The fluence indicator displays
the user-selected fluence. The UP or DOWN buttons are used to
increase or decrease the fluence selection from the available settings. See System Specifications section for available settings. Fluence is measured in Joules per square centimeter (J/cm2).
Pulse Duration Indicator and Controls - The Pulse Duration
Indicator displays the user-selected pulse width. The UP and
DOWN buttons are used to increase or decrease pulse width selection from the available settings. See System Specifications section
for available settings. Pulse width is measured in milliseconds
(ms).
Repetition Rate Indicator and Controls - This indicator displays user-selected repetition rate. The UP and DOWN buttons
are used to increase or decrease the repetition rate from the available settings. This is the frequency that the laser delivers light
pulses while the footswitch is held down. See System Specifications section for available settings. Repetition rate is measured in
Hertz (Hz).
Laser Status Indicator Icon - The laser status indicator icon illuminates yellow during the initial power-on and self test. The indicator illuminates green when the power-on self tests are
successfully completed. If a system problem occurs, the system
status indicator illuminates red, a fault code will appear in the
Pulse Count Display and the system will remain in the STANDBY
mode. All user-clearable error codes may be cleared by pressing
the STANDBY or READY button. If this fails to clear the error
code, please contact your local Cutera Service Representative for
assistance. Refer to Appendix E.
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Handpiece Status Indicator Icon - The handpiece status indicator
icon illuminates yellow as the chilled contact surface of the handpiece
is cooling down to the factory-specified treatment temperature. The
icon will then illuminate green when the proper temperature is
achieved. If during treatment, the temperature of the chilled contact
surface exceeds the factory-specified temperature setting, the handpiece status indicator icon will illuminate yellow and the system will
automatically switch to STANDBY. The icon will return to green once
the proper temperature is achieved. Treatment may then be resumed by
pressing the READY button. If during treatment the Handpiece icon
illuminates red, the system will go to STANDBY and an error will
appear in the pulse count display.
Water Icon (CoolGlide Excel, CoolGlide Vantage and the Genesis
Laser) - Indicates that the system has proper amount of water when
illuminated green. If the water icon is blinking, turn the system off,
add water (see Maintenance and Troubleshooting section) and turn the
system back on.
Footswitch Icon - The footswitch serves as the only way to activate
the laser during treatment. The Footswitch icon illuminates green after
the initial power-on and self-test. Connection of the footswitch prior to
startup is necessary for system recognition and use. See System Operation section for proper startup procedure.
On the CoolGlide Excel, CoolGlide Vantage and the Genesis Laser,
the Footswitch icon will blink when a fault occurs with the footswitch.
If the Footswitch icon is blinking, insert the footswitch plug and press
STANDBY to clear the error.
STANDBY Button - The STANDBY button illuminates yellow when
the system is in this mode. Depressing the STANDBY button causes
the system to enter into STANDBY mode. User-clearable codes may
be cleared by pressing the STANDBY or READY button.
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READY Button - The READY button illuminates green when the
system is in the READY mode. Depressing the READY button causes
the system to go into READY mode only after all system and safety
criterias are met. When switching from the STANDBY mode to the
READY mode, the READY button will flash for approximately three
seconds and then will remain illuminated green to indicate the laser is
ready to deliver a treatment pulse in response to the footswitch. Userclearable error codes may also be cleared by pressing either the
READY or STANDBY button.
Emission Indicator Icon - The emission indicator icon illuminates
orange, indicating there is laser emission (treatment pulses).
Pulse Counter - The pulse counter displays the cumulative number of
laser pulses delivered since pressing the reset button. The CoolGlide
will automatically reset the display after the system is power cycled
and READY. On the CoolGlide Excel, CoolGlide Vantage, Genesis
laser system, the display will not automatically reset during the power
cycle.
Pulse Counter Reset Button - Pressing the Pulse-Counter Reset button zeros the counter.
Aiming Beam Adjustment (CoolGlide Excel, CoolGlide Vantage
and the Genesis laser system) - There are 5 different modes that the
aiming beam can be in: Off, low, medium, high and full intensity.
Within each of those modes, the aiming beam can be set to blinking or
non-blinking with the exception of the Off mode. When the system is
first turned on, the aiming beam default mode will be at high.
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The aiming beam mode can be changed by pressing and holding the READY button for three
seconds. A beep will sound and all the displays on the control panel will go blank except for
the Repetition Rate display, which will display the current aiming beam mode number. In order
to configure the aiming beam mode, use the Repetition Rate UP/DOWN buttons to select the
desired aiming beam mode (number) as follows:
0 - Off
1 - on, low intensity
2 - on, medium intensity
3 - on, high intensity
4 - on, full intensity
5 - blinking, low intensity
6 - blinking, medium intensity
7 - blinking, high intensity
8 - blinking, full intensity
The default aiming beam modes are stored in system memory for each of the available spot
sizes. To change to a different aiming beam mode for a specific spot size, select the spot size
first then adjust the aiming mode as described above.
Exit the aiming beam adjustment mode by pressing STANDBY or READY. If the aiming beam
adjust mode is left for more than twenty seconds with no user input, the system will exit the
aiming beam mode and return to STANDBY.
Spot Size Indication - (CoolGlide Excel, CoolGlide Vantage and the Genesis laser) - These
systems will display the selected spot size in the Pulse Count Display when in STANDBY. The
system will issue a continuous beep and display “EEEE” in the Shot Count display if the spot
size selector on the handpiece is between detents.
NOTE
For the CoolGlide Excel, CoolGlide Vantage and the Genesis laser
system, the Pulse Count display will be center justified when displaying spot size and right justified when displaying the pulse
count.
D0237, REV. C, 6/14
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System Specification*
Laser
Type
High power, long pulse Nd:YAG
Wavelength
1064nm
Output
100 J Max.
Fluence
CoolGlide: 10 to 100 J/cm2
CoolGlide Excel: 5 to 300 J/cm2
CoolGlide Vantage: 3 to 300 J/cm2
Genesis: 3 to 300J/cm2
Pulse Duration
CoolGlide: 10 to 100ms
CoolGlide Excel: 1 to 300ms
CoolGlide Vantage: 0.1 to 300ms
Genesis: 0.1 to 30ms
Repetition Rate
CoolGlide & CoolGlide Excel: Single shot and up to
2 Hz
CoolGlide Vantage & Genesis: Single shot and up to
10 Hz
Delivery System
Permanently attached umbilical cable and handpiece
Spot Size
10 mm fixed spot size (CoolGlide)
3.0, 5, 7, 10 mm adjustable spot (CoolGlide Excel,
CoolGlide Vantage and the Genesis laser system)
Epidermal Cooling
Contact pre-cooling and/or post-cooling provided
chilled contact surface
System Cooling
Self contained, water to air heat exchanger
Aiming Beam
615nm (CoolGlide Excel, CoolGlide Vantage and the
Genesis laser system)
*Specifications subject to change without notice.
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Physical Parameters
Size (W X D X H)
13 in. x 18 in. x 32 in. (.33 m x .46 m x .81 m)
Weight
135 lbs. (57 kg.)
Operating length of
umbilical
77 in. (1.95 m)
Minimum bend
radius of umbilical
Storage
Momentary
5 in. (126 mm)
2 in. (50 mm)
Electrical Requirements
Voltage, Current
100 - 120 VAC/20A
200 - 240 VAC/20A (U.S. only)
200 - 240 VAC/16A (International)
Frequency
50/60 Hz
Ambient Operating Conditions
Temperature
Operating
Storage
Humidity
0 - 90%
Max Heat Dissipation
4,000 Watts
10º to 32º C
-10º to 50º C (water drained)
Classifications
FDA Classification
CDRH Classification
Class II Medical Device
Class IV Laser Product
IEC 60825-1Classification
Class 4 Laser
D0237, REV. C, 6/14
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Eye Safety
Nominal Ocular Hazard Distance
Minimum Optical Density for
Protective Eyewear
81 m at 1064 nm
6.1 at 1064 nm
Maximum Permissible Exposure
2.69* 10-4 W/cm2 at 1064 nm
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D0237, REV. C, 6/14
37
System Operation
The following section describes the user operation procedure for the family of CoolGlide laser
systems.
NOTE
Use of controls or performance of procedures other than those specified herein may result in hazardous laser exposure. See Safety and
Regulatory section for additional information.
System Start Up
WARNING
Before beginning each procedure, make certain that the patient and
all personnel are wearing appropriate protective eyewear. Unprotected laser exposure can cause permanent eye damage.
1.
Make certain the handpiece is resting in the storage receptacle and that the footsiwtch is
connected to the system.
2.
Make certain the system is plugged in. Move the circuit breaker switch to the ON position (located on the rear of the laser console near the power cord).
D0237, REV. C, 6/14
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3.
Insert the key into the key switch, rotate clockwise to the START position and hold
momentarily. Verify that the Laser Status Indicator icon illuminates yellow.
4.
Release the key. The key will automatically return to the ON position.
5.
Wait for the Laser Status Indicator icon to illuminate green and the STANDBY button to
illuminate yellow.
1.
Make sure the system is in STANDBY mode.
2.
(For CoolGlide Excel, CoolGlide Vantage and the Genesis laser only) Select the desired
spot size by adjusting the spot size control on the handpiece.
3.
Select the desired pulse width by depressing the UP or DOWN buttons on the PULSE
WIDTH control. See System Specifications section for available pulsewidths.
System Use
NOTE
If the user decreases the pulse width to a value that causes the fluence setting to exceed the maximum allowed setting for that pulse
width, the fluence value will be decreased accordingly. Also in vice
versa, if the user increases the pulse width to a value that would
cause the fluence setting to exceed the minimum allowed setting for
that pulse width, the pulse width value will not be changed. In this
case, the fluence must be increased prior to increasing the pulse
width.
4.
Select the desired fluence by pressing the UP or DOWN buttons on the FLUENCE control. See System Specifications section for available fluences.
NOTE
If the user increases the fluence so that the fluence and repetition
rate combined exceed the maximum allowable power based on the
voltage and current configuration of that system, the repetition rate
will automatically be adjusted by the system in order to remain
within the allowable settings. The available range of fluences are
affected by the pulse width setting.
D0237, REV. C, 6/14
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5.
Select the desired repetition rate by pressing the UP or DOWN buttons on the REPETITION RATE control. See System Specifications section for available repetition rates.
CAUTION
The repetition rate function should only be used once the user has
gained sufficientexperience in single shot mode and only for treatments where it is appropriate.
NOTE
The available range of repetition rates are affected by the fluence
setting and the maximum allowable power based on the voltage and
current configuration of the system.
6.
Remove the handpiece from the storage receptacle. Be sure the handpiece is pointed in a
safe direction.
7.
Place the chilled contact surface area of the handpiece on the area to be treated.
CAUTION
For hair removal and vasculare treatments, the handpiece cooling
surface and treatment guide should be in contact with the skin prior
to laser emission. The repetition rate shunction should only be used
once the user has gained sufficient experience in single shot mode.
8.
Press the console READY button. Wait for the button to stop flashing and illuminates
green. Once in READY mode, the system will emit 1064 nm laser energy when the
footswitch is depressed.
NOTE
Condensation forming on the chilled contact surface is normal and
therefore, does not need to be wiped off.
9.
(For CoolGlide Excel, CoolGlide Vantage and the Genesis laser only) The aiming beam
will be visible depending on the configuration setting. To adjust the aiming beam, press
and hold the READY button for three seconds. A beep will sound from the laser and all
the displays will show blank except for the (Hz) display, which will display the current
aiming beam mode. Use the Hz UP/DOWN buttons to select the desired aiming beam
mode as shown in the table below:
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Table 1: Different Aiming Beam Modes
Display
Number
On/Off
0
Off
1
On
Low
2
On
Medium
3
On
High
4
On
Full
5
Blinking
Low
6
Blinking
Medium
7
Blinking
High
8
Blinking
Full
Intensity
The different aiming beam modes are stored in system memory for each of the available spot
sizes. To change the aiming beam mode for a specific spot size perform the following steps:
a. Select the spot size.
b. Adjust the aiming beam mode as described in the above table.
c. Exit the aiming beam adjustment mode by pressing either the STANDBY or
READY buttons. The new setting will automatically be stored in system memory.
NOTE
If the system is left in the Aiming Beam Adjustment mode for more
than 20 seconds with no user input(s), the system will exit the Aiming Beam Adjustment mode and return to STANDBY.
10.
Glide the handpiece in the direction of the pre-cooled epidermis while aligning the laser
treatment guide for consistent coverage. Depress the footswitch to deliver the treatment
pulse(s) on the area that has been pre-cooled.
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CAUTION
For hair removal and most vascular treatments, the treatment pulses
should only be delivered to areas that have been pre-cooled by the
chilled contact surface just prior to treatment.
See the Treatment Guidelines accompanying this manual for more
information. Treatment Guidelines can also be obtained from your
local Cutera Representative.
NOTE
Depending upon the treatment (i.e. vascular treatment), glide the
cooling portion of the handpiece over the treated area to post-cool
the epidermis.
11.
Place the system in STANDBY mode by depressing the STANDBY button when treatment is complete.
12.
Clean the handpiece (refer to the Maintenance & Troubleshooting section). Place the
handpiece in the storage receptacle and if required, record the clinical settings (parameters used), prior to turning the system off.
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System Shut Down
1.
Depress the SATANDBY button on the console to return the system to the STANDBY
mode once treatment is completed.
2.
Place the handpiece in the storage receptacle.
3.
Shut the laser down by turning the key to the OFF position or by depressing the EMERGENCY OFF button.
4.
Remove the key from the laser.
NOTE
When performing subsequent treatments on patients, leave the system on and in the STANDBY mode to allow for adequate cooling.
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Clinical Application
Indications for Use
The family of CoolGlide laser systems is intended for use in surgical and aesthetic applications
requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology.
• For removal of unwanted hair.
• For stable long-term, or permanent hair reduction through selective targeting of
melanin in hair follicles.
• For treatment of pseudofolliculitis barbae (PFB).
• For use on all skin types (Fitzpatrick I-VI), including tanned skin.
• For coagulation and hemostasis of benign vascular lesions such as, but not limited
to, hemangioma, port wine stains, telangiectasias, rosacea, venous lakes, leg veins,
spider veins and poikiloderma of Civatte.
• For treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
• For the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• For treatment of warts.
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Contraindications for Use
Contraindications for use:
• Pregnant patients
• Patients undergoing treatment for skin cancer
Precautions
• Photosensitizing drugs (Tetracyclines, etc.)
Be aware that you may have to adjust the treatment parameters according to
clinical response from test area(s).
• Anticoagulants
May increase risk of purpura or bruising
• History of coagulpathies
• History of keloids or hypertropic scarring
• Diabetes
May impede wound healing
• History of herpes
Pre-treatment with an antiviral may be indicated
• Accutane use
• History of vitiligo
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Expected Transient Events and Possible Adverse Effects
• Erythema, edema and purpura may occur following treatment and typically resolve
with time.
• Hyperpigmentation, hypopigmentation, burns, erosion or blistering may occur,
some of which may result in scarring. .
• Deep tissue injury and prolonged wound healing may occur when treating warts.
CoolGlide laser systems should only be operated by qualified personnel who have received
appropriate training. In addition to the information provided in the Safety and Regulatroy section, the following safety precautions are recommended during use of the laser system:
• Guard against accidental exposure to laser energy.
• Instruct all staff members to carefully aim the treatment beam only at the targeted
treatment areas.
• Ensure that the patient and all staff personnel in the treatment room wear appropriate protective eyewear. If the patient can not wear eyewear, be sure to fit the patient
with opaque eye protection that will completely block light to the eyes. The eyewear must provide adequate protection from laser radiation of the wavelength being
used. See Safety and Regulatory section for protective eyewear requirements.
• Instruct all staff members and patients to never look directly at the laser light or
reflective surfaces, even when wearing proper protective eyewear.
WARNING
While the laser is in use, never allow anyone near the laser without
proper protective eyewear. Unprotected laser exposure could cause
permanent eye damage.
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Patient Information
Prior to treatment, the user should conduct a patient consultation. The consultation should
include a complete medical history and exam. At that time, the user should also discuss all
potential benefits, complications, options and risks of treatment.
Treatment Information for Vascular Lesions, Hair Removal and Non-Ablative
Procedures
• For information on operating the family of CoolGlide laser systems, refer to the
System Operation section.
• For treatment specific guidelines, refer to the Hair Removal Guidelines, the Vascular Treatment Guidelines, and the Non-Ablative Treatment Guidelines accompanying this manual. These guidelines can also be obtained from your local Cutera
representative or online at www.cutera.com.
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Maintenance
Troubleshooting Guide
If the instrument fails to operate properly, this troubleshooting guide will help you locate and
correct the malfunction. First, please check for the following items:
1.
Electrical power source... verify that the electrical disconnect switch, the circuit breaker, is
turned on.
2.
Laser console electrical... verify that the laser is on and properly connected to an electrical
service outlet.
3.
External door interlock... if the external door interlock is used in conjunction with a
remote switch, verify that the external door interlock plug is inserted in the external door
interlock receptacle. Close the interlocked door.
System does not turn on. The front panel indicators do not illuminate.
Probable Cause:
Solution:
Power cord is not plugged in.
Place the laser’s main power circuit breaker in the OFF
position, insert the laser electrical plug into the appropriate
outlet, and place the laser’s main power circuit breaker in the
ON position.
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Probable Cause:
Solution:
The building power (main electrical service) is turned off.
Turn on the building power.
Probable Cause:
Solution:
The laser’s main power circuit breaker is in the OFF position.
Place the laser’s main power circuit breaker in the UP
position.
Probable Cause:
Solution:
The electrical outlet is defective.
Use another outlet or have the outlet professionally tested
and, if appropriate, repaired.
Laser goes into STANDBY during the procedure.
Probable Cause:
Solution:
Handpiece cooling tip is not maintaining the temperature.
Do not use a thick layer of gel as this increases the cooling
requirement.
System shuts down during operation with no front panel display.
Probable Cause:
Solution:
The building power (main electrical service) is tripped off.
Verify and/or turn on the building power.
Probable Cause:
The laser’s main power circuit breaker is tripped to the OFF
position.
Place the laser’s main power circuit breaker in the UP
position.
Solution:
Probable Cause:
Solution;
Remote interlock is in use and the treatment room door has
been opened.
Close the treatment room door and restart the system.
The laser does not emit laser energy although the laser is on.
Probable Cause:
Solution:
D0237, REV. C, 6/14
The system is in STANDBY mode.
Place the system is READY mode.
49
The Handpiece status icon indicator is yellow with the green READY button blinking.
Probable Cause:
Solution:
Handpiece has not reached the appropriate pre-cooling
treatment temperature.
Wait for approximately one minute to allow the handpiece
tip to cool down. When the handpiece has reached the
appropriate temperature, the handpiece icon will illuminate
green.
Seeing an advisory message E250.
Probable Cause:
Solution:
Footswitch is not plugged in or the footswitch is defective.
Turn off the laser. Plug in the footswitch and restart the
laser.
The footswitch icon is blinking green but the system icon is red.
Probable Cause:
Solution:
Footswitch is not plugged in or the footswitch is defective.
Turn off the laser system. Plug in the footswitch and restart
the laser system.
Seeing an advisory message E322. Refer to figure on the next page.
Probable Cause:
Solution.
The system is low on water.
Turn the laser OFF and add water as instructed earlier in this
section of this manual. Turn the laser back on prior to
proceeding with treatments.
The water icon is blinking and the system icon is red.
Probable Cause:
Solution.
The system is low on water.
Turn the laser OFF and add water as instructed earlier in this
section of this manual. Turn the laser back on prior to
proceeding with treatments.
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Water Icon
Display shows “EEE” with the handpiece icon illuminated and a loud tone is heard.
Probable Cause:
Solution:
The spot size selection ring on the handpiece is in between
the selectable spot size detents. This only applies to the
CoolGlide Excel, CoolGlide Vantage and the Genesis laser
system.
Move the spot size selection ring to the appropriate spot size
detent.
Low or no laser energy output (patient reports no sensation).
Probable Cause:
Solution:
Window is dirty or damaged.
Confirm that the laser energy is not being emitted on test
area, such as arm. Clean or replace the window as described
in this manual. If the problem is not resolved, call your local
Cutera representative (see Appendix E).
If any error codes or symptoms occur that are not addressed in the troubleshooting guide or if
the suggested solutions do not resolve the problem, contact your local Cutera representative
(see Appendix E).
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User Maintenance
Cleaning the External Surfaces of the System Console
Use a cloth dampened with non-caustic cleaning solution, such as mild soap and water, isopropyl alcohol, or a “hospital-grade” disinfectant, to wipe the external surfaces of the system console. Dry with a clean cloth, or allow to air dry.
WARNING
Do not attempt to gain access to any internal components. Electrical
shock and/or unintended laser exposure may result. Do not spray or
pour cleaning agents directly on the system console.
Cleaning the Handpiece Window
The recessed handpiece window is located at the distal end of the handpiece. Inspect the window for debris prior to each treatment as well as periodically during treatment. In both cases,
ensure that the system is OFF or in the STANDBY mode prior to inspection.
WARNING
The system must be turned OFF or in the STANDBY mode prior to
inspecting the window. Do not inspect the window while the system
is in READY mode. Always wear proper eyewear while the system
is ON. Severe eye damage can occur in the event of unintended
laser emission.
CAUTION
If the window is not properly maintained, debris can build up on the
window surface, which will lead to permanent damage to the window and ultimately permanent damage to the handpiece optical system.
NOTE
Ejected hair from the patient can accumulate on the window, and
the window must be cleaned using the technique described below.
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Clean the handpiece window using a clean wood stick cotton swab and lens cleaning grade
acetone, as described below.
NOTE
For optimal results, use acetone with 0.5% or lower water content,
which is available at most camera shops. If unable to obtain acetone
with 0.5% or lower water content, contact your local Cutera representative (see Appendix E).
NOTE
Use only wood stick cotton swabs. Do not use products such as QTips as they contain an adhesive that dissolves when it comes in
contact with acetone.
1.
Ensure that the system is turned OFF or is in STANDBY mode.
2.
Place a small amount of acetone on a wood stick cotton swab; if necessary, shake the
excess acetone off of the tip prior to cleaning the handpiece window.
3.
Gently wipe the surface of the window. Refer to the picture below.
Cleaning the Surface Window
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53
4.
Inspect the window. If necessary, clean the window again with a new cotton swab.
NOTE
The window must be clean before treating a patient. A cloudy
appearance is acceptable. Chips, pits, cracks or burned spots on the
window are not acceptable, and a window with these types of
defects must be replaced. If debris cannot be cleaned off the window, the window must be replaced. Refer to the picture below.
(Acceptable)
(Unacceptable)
Window Free of Debris
D0237, REV. C, 6/14
54
Replacing the Handpiece Window
If the handpiece window is damaged or if debris cannot be cleaned off the window, replace the
window as described below.
1.
Ensure that the system keyswitch is in the OFF position.
2.
Point the handpiece down towards the floor, and insert the window removal tool into the
handpiece aperture. Refer to the picture below.
Replacing the Window
3.
Gently unscrew the old window and replace with a new window. Ensure that the handpiece is pointed down towards the floor while inserting the new window.
CAUTION
Do not attempt to sterilize the handpiece. Damage will occur if the
handpiece is autoclaved, immersed or otherwise handled improperly.
D0237, REV. C, 6/14
55
Disinfecting the Handpiece Tip
Disinfect the handpiece tip (i.e., cooling surface and treatment guide) between patient use with
a germicidal disposable wipe, such as Sani-Cloth® Plus or Sani-Cloth® HB from Professional
Disposables International, Inc.1
WARNING
Before disinfecting the handpiece tip, ensure that the system is
either turned OFF or in the STANDBY mode. Always wear proper
protective eyewear while the system is ON. Severe eye damage can
occur in the event of unintended laser emission.
Cleaning the External Surfaces of the Handpiece
Clean the umbilical cable and handpiece housing as needed, using a soft cloth dampened with
mild detergent and water.
CAUTION
Do not allow liquid or cleaning solution to enter the handpiece
housing as damage may occur.
1. Sani-Cloth Plus and Sani-Cloth HB are registered trademarks of Professional Disposables International, Inc.
D0237, REV. C, 6/14
56
Inspecting and Cleaning the Heat Exchanger Intake
The heat exchanger intake, located on the bottom of the system console, should be kept free of
dust and lint accumulation. If the heat exchanger intake becomes clogged, the system will
overheat prematurely, resulting in a temperature-related error code (i.e., E221, E224, or E229).
Inspect and clean the heat exchanger regularly using a hand mirror and long-handled bath
brush as described below.
1.
Using a hand mirror, inspect the bottom of the system console for dust or lint accumulation.
2.
Clean the heat exchanger intake by inserting a long-handled bath brush under either side
of the system console, then pulling the brush toward your body to remove any dust or lint.
3.
Repeat on the opposite side of the console to ensure that the entire heat exchanger intake is
clean.
D0237, REV. C, 6/14
57
Fill Coolant
The CoolGlide laser systems require clean de-ionized/distilled water. Laser systems are delivered without any water in it and must be filled with de-ionized water upon installation. Occasionally, de-ionized water may need to be added to top off the system.
CAUTION
Damage to laser components will occur if improper coolant is used.
One gallon of de-ionized water is shipped with every system. Under
no circumstances should Ethylene Glycol be used, otherwise degradation of internal components will result.
The following procedure should be followed to completely fill the coolant reservoir in the
CoolGlide Laser system.
1.
Turn the system off and disconnect the AC power cord from the AC power source.
2.
Remove the plug from the fill port by pulling straight out. The fill plug is located on the
rear of the system. Refer to picture below.
Remove the Fill Plug
3.
Locate the white plastic bottle with a hose connected at the bottom.
4.
Feed the 1/8” vent hose completely into the Fill Port on the rear of the system.
NOTE
The 1/8” hose is supplied with the system.
D0237, REV. C, 6/14
58
Insert the Fill Bottle Hose into Fill Port
NOTE
Before adding the water, the fill bottle must be engaged into the fill
port and flush with the rear cover. Press the fill bottle tube into the
laser system fill port until completely engaged. Firm pressure is
required to overcome the o-ring friction.
Pour De-Ionized Water Into the Fill Bottle
5.
Fill the plastic bottle and allow the coolant to flow into the CoolGlide cooling system. Use
only clean, unused de-ionized water provided.
D0237, REV. C, 6/14
59
6.
Once the water stops flowing out of the fill bottle and into the system, turn the laser system keyswitch to the START position and release to the ON position.
This engages the water pump allowing the coolant to be drawn into the cooling
system. Allow the system to run for 5 to 10 seconds.
7.
Turn the keyswitch to the OFF position.
8.
Top off the fill bottle.
It may be necessary to gently blow into the 1/8” hose at the top of the fill bottle
to clear the air out of the fill tube.
9.
Repeat steps 6 thru 8 approximately four times or until no water flows out of the fill bottle
and into the system.
NOTE
The coolant capacity of the laser system is approximately half a
gallon.
10. If any excess water is found in the fill bottle, place the one gallon de-ionized water bottle
below the fill bottle and rotate the fill bottle until the water empties out.
Removing Excess Water
11. Remove the plastic bottle completely out of the fill port.
12. Replace the fill plug into the fill port by hand.
D0237, REV. C, 6/14
60
Facility Requirements
The room in which the unit will be functioning is to maintain an ambient temperature of 80º F
or below.
Calibration Procedure
Regulatory agencies require that manufacturers of US FDA CDRH Class III and IV and IEC
60825-1 Class 3 and 4 medical lasers supply their customers with power calibration instructions.
Calibration of the laser output should be checked periodically. With proper care under normal
operating conditions, Cutera recommends calibration every twelve (12) months to ensure that
the laser energy delivered from the handpiece corresponds accurately to the user-selected settings. The following procedure should also be performed after any service or repair work.
Excessive vibration may necessitate more frequent calibration.
DISCLAIMER WARNING
Calibration is a service procedure to be done only by Cutera-certified representatives who have taken and passed an Cutera Service
Certification Training course. Adjustment by anyone other than a
trained Cutera representative voids any existing manufacturer’s
warranty or maintenance contract on the instrument. A service
manual for the laser may be purchased from the Cutera Service
Department, however possession of service instructions or service
tooling does not authorize repair or modification of a Cutera system
by uncertified personnel.
Calibration must be performed by an engineer or technician qualified to work on energized
electronic laser equipment. Questions regarding this procedure should be referred to your local
Cutera representative.
D0237, REV. C, 6/14
61
Equipment Required
• Laser safety eyewear for all persons in the room (with appropriate optical densities
at the wavelengths being generated).
• Laser energy meter (Ophir Nova display unit model L40-150A-SH sensor). The
instrument used must have received a NIST-traceable calibration within the past 12
months (in the US) or a calibration conforming to the applicable standard (internationally).
Calibration Instructions
1.
Set up the laser energy meter in a convenient place so the sensor head can be easily
reached with the handpiece. Set the meter display unit to the ENERGY mode.
2.
Make sure all personnel in the room are wearing the appropriate protective eyewear.
3.
Connect the service computer to the serial port.
4.
Start the system in service mode and using the Cutera Service software, place the system
in CALIBRATION mode.
5.
Follow the prompts on the calibration screen.
6.
Place the system User mode and verify the calibration using an external meter.
CAUTION
Any work performed by an unauthorized personnel will void all
warranties.
D0237, REV. C, 6/14
62
End of Life Disposal - Environmental Information
CoolGlide laser systems must be disposed of according to local laws and hospital practices.
This product is considered electronic equipment and must not be disposed of as unsorted
municipal waste and must be collected separately. Please contact the manufacturer or other
authorized disposal company to decommission your equipment.
Warranty Information
For specific and detailed warranty information for the CoolGlide laser system, please refer to
the first page of your purchase “Agreement” and the last page of the “Terms and Conditions of
Sale”.
D0237, REV. C, 6/14
APPENDIX A
A-1
Laser Warning Sign
DANGER
INVISIBLE LASER RADIATION — AVOID
EYE OR SKIN EXPOSURE TO DIRECT OR
SCATTERED RADIATION. USE PROPER
EYEWEAR WHEN OPERATING AND/OR
TREATING PATIENTS.
Nd:YAG 1064 nm
Class 4 Laser Product
Per IEC 60825-1:2007
3000028 rC
Laser Warning Sign for CoolGlide/CoolGlide Excel/CoolGlide Vantage / Genesis
D0237, REV. C, 6/14
APPENDIX A
A-2
THIS PAGE IS BLANK
D0237, REV. C, 6/14
APPENDIX B
B-1
Symbols
This appendix describes the laser system symbols and their meanings.
Symbol
Standard
Reference
Description
Location
N/A
Cutera logo
Control panel
417-5007
Mains ON
Rear panel (at circuit breaker) and
control panel (next to keyswitch)
417-5008
Mains OFF
Rear panel (at circuit breaker) and
control panel (next to keyswitch)
417-5104
Momentary start
Control panel (next to keyswitch)
DIN 18734
Emergency OFF
Control panel (next to red button)
417-5266
Standby
Control panel
417-5264
Ready
Control panel
DIN 18734
Fluence (J/cm2)
Control panel
DIN 18734
Exposure duration (ms)
Control panel
D0237, REV. C, 6/14
APPENDIX B
B-2
Symbol
Standard
Reference
Location
DIN 18734
Repetition rate (Hz)
Control panel
DIN 18734
Pulse counter reset
Control panel
Cutera-defined
Aiming beam adjustment
Control panel
Cutera-defined
Laser emission indicator
Control panel
Cutera-defined
Laser status
Control panel
Cutera-defined
Handpiece status
Control panel
Cutera-defined
System water status
Control panel
Cutera-defined
Footswitch status and footswitch
receptacle
Control panel and rear panel label
Remote interlock connector (as
defined in 3.67 of IEC 825-1)
Rear panel label
Model number
Rear panel label
IEC 60825-1
REF
Description
ISO 980
D0237, REV. C, 6/14
APPENDIX B
Symbol
SN
B-3
Standard
Reference
Description
Location
ISO 980
Serial number
Rear panel label
ISO 980
Date of manufacture
Rear panel label
ISO 980
Manufacturer
Rear panel label
TUV Mark
Rear panel label
Refer to instruction manual
Rear panel label
Waste of electrical and electronic
equipment must not be disposed as
unsorted municipal waste and must
be collected separately.
Rear panel label
IEC 60601-1
Type BF equipment
Rear panel label
IEC 60825-1
Laser radiation warning
Rear panel label
IEC 60601-1
WEEE Directive
D0237, REV. C, 6/14
APPENDIX B
B-4
THIS PAGE IS BLANK
D0237, REV. C, 6/14
APPENDIX C
C-1
Bibliography
1.
Anderson RR, Parish JA, Selective Photothermolysis: Precise Microsurgery by Selective Absorption of Pulsed
Radiation. Science 1983; 220:524-7.
2.
Groot D, Rao J, Johnston P, Nakatsui T. Algorithm for using a long-pulsed Nd:YAG laser in the treatment of
deep cutaneous vascular lesions. Dermatologic Surgery 2003; 48:76-81.
3.
Tanzi EL, Alster TS. Long-pulsed 1064-nm Nd:YAG laser-assisted hair removal in all skin types. Dermatologic
Surgery 2003; 30(1): 13-7.
4.
Omura NE, Dover JS, Arndt KA, Kauvar AN. Treatment of reticular leg veins with a 1064 nm long-pulsed
Nd:YAG laser. Journal of the American Academy of Dermatology 2003, 48(1): 76-81.
5.
Rogachefsky A, Silapunt S, Goldberg D. Nd:YAG laser (1064 nm) irradiation for lower extremity telangiectasias
and small reticular veins: efficacy as measured by vessel color and size. Dermatologic Surgery 2002; 28:220-3.
6.
Sarradet D, Hussain M, Goldberg D. Millisecond 1064-nm Neodymium:YAG laser treatment of facial telangiectasias. Dermatologic Surgery 2003; 29:56-8.
D0237, REV. C, 6/14
APPENDIX C
C-2
THIS PAGE IS BLANK
D0237, REV. C, 6/14
APPENDIX D
D-1
Error Code Guide
The Cutera family of CoolGlide laser systems utilizes state -of-the-art, self-diagnostic software. In anticipation of or as a result of a system problem, an Error Code will appear in the
Pulse Counter Display window located on the control panel. Some of these codes serve as a
warning and many are clearable by simply pressing either the STANDBY or READY button.
Some however require service by an authorized Cutera Service Technician. Below is a brief
explanantion of some of the codes. If you have any questions about this information or the
operation and service of your system, feel free to contact your local Cutera representative
(refer to Appendix E).
Error Code Series/Description
Error Code*
Series 100 Codes - Series 100 Codes appear as a
“warning” and typically will not hinder the treatment(s). Most Series 100 Codes are clearable by
resuming treatment or by pressing the READY or
STANDBY button located on the control panel. If
after pressing the READY or STANDBY button,
the code does not clear, power off and re-start the
system.
Code 120 - System operating under extreme conditions. Treatment parameters or environmental conditions are less than
ideal.
Series 200 Codes - Series 200 codes are “user clearable” faults and must be cleared in order to resume
treatment(s). To clear, press either the READY or
STANDBY button located on the control panel. If
after pressing the READY or STANDBY button,
the code does not clear, power off and re-start the
system.
Code 250 - Footswitch is unplugged or an attempt was made by
user to enter the READY mode while footswitch was
depressed. If unplugged, turn off system, plug in footswitch and
restart system. If attempt was made to enter READY mode with
footswitch depressed, release footswitch and press the READY
button.
Series 300 Codes - Series 300 codes indicate a “permanent fault” and the system must be powered off
and restart in order to clear the code. If this fails to
clear the code, contact your local Cutera representative to schedule an appointment.
Code 322 - Water level in the system is low. Add de-ionized/
distilled water only.
* Contact your local Cutera representative if additional alert codes appear.
D0237, REV. C, 6/14
APPENDIX D
D-2
THIS PAGE IS BLANK
D0237, REV. C, 6/14
APPENDIX E
E-1
Cutera Direct Office Locations
Cutera World Headquarters
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005
Telephone: (888) 4-CUTERA or (415) 657-5500
Fax: (415) 330-2444
Service: (866) 258-8763
Cutera (Japan)
Cutera K.K.
Shibuya Infoss Annex Bldg, 3rd fl.
12-10 Sakuragaoka
Shibuya-ku, Tokyo 150-0031
Tel: +81 (0) 3 5456 6325
Fax: +81 (0) 3 5456 2213
D0237, REV. C, 6/14
APPENDIX E
E-2
THIS PAGE IS BLANK
D0237, REV. C, 6/14

COOLGLIDE FAMILY OF Nd:YAG OPERATOR MANUAL LASER

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