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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 transla-
tions 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 con-
tained herein are subject to change without notice.
Cutera, Inc.
3240 Bayshore Boulevard
Brisbane, CA 94005 USA
GMDN: 35940
UMDN: 17-775
Contents
Introduction 1
Oveview 1
Operator Training 3
Indications for Use 3
Contraindications for Use 4
Precautions 4
Site Preparation 19
Requirements 19
Unpacking 20
Installation 20
Remote Interlock 20
Treatment Room Safety 21
System Description 23
Console 23
ClearView Handpiece 25
COOLGLIDE FAMILY OF ND:YAG LASER SYSTEMS
D0237, REV. C, 6/14
iv
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 B - Symbols
Appendix C - Bibliography
Introduction
Overview
Console (Front)
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:
• 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 Specifica-
tions section for additional information.
The laser system is designed to be safe when used by and under the supervision of trained pro-
fessionals. The laser radiation emitted from the laser system can be harmful if proper proce-
dures are not followed.
NOTE
Steps that are critical for proper use of the system, or present a
potential safety hazard, will be indicated by WARNING.
Operator Training
CAUTION
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.
• 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.
• Pregnant patients
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
• History of coagulpathies
• Diabetes
• History of herpes
• Accutane use
• History of vitiligo
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
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 suffi-
cient protection (optical density specified or greater in System Specifications) at the wave-
length 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 pro-
tective 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 Facili-
ties (ANSI Z136.3-2005).
• The American National Standard for Safe Use of Lasers (ANSI Z136.1-2007) pro-
vide guidance for the safe use of lasers and laser systems in diagnostic and thera-
peutic areas.
The above standards describe the following terms in the description of laser hazards:
• 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.
Electrical Hazard
• High Voltages are present inside the system. Do not remove the exterior housing.
• 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 discon-
nected 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
WARNING
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
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 with-
out 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 can-
not 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.
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. Fol-
lowing emergency shutoff, the keyswitch must be used to restart the system.
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.
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 radi-
ation above Class I limits. The housing must only be opened by a Cutera-certified representa-
tive.
No section of the protective laser system housing can be opened without special tools.
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.
Each laser pulse delivered is accompanied by an audible beep. In addition, when the Cool-
Glide 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.
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
WARNING
CAUTION
NOTE
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.
RF emissions CISPR 11 Class B CoolGlide systems are suitable for use in all
establishments, including domestic
Harmonic emissions IEC61000-3-2 Class A establishments and those directly connected
to the public low voltage power supply
Voltage Fluctuations/flicker emissions Complies
network that supplies buildings used for
IEC61000-3-3
domestic purposes.
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.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance
Electrostatic ±6kV contact ±2, 4, 6kV contact Floor should be wood, concrete, or ceramic
Discharge (ESD) tile. If floors are covered with synthetic
±8kV air ±2, 4, 8kV air material, the relative humidity should be at
IEC61000-4-2 least 30%.
Electrical fast ±2kV for power supply ±2kV line to ground Mains power quality should be that of a
transient/burst lines typical commercial or hospital environment.
±1kV line to line
IEC61000-4-4 ±1kV for input/output
lines
Surge ±1kV differential mode ±0.5, 1kV Mains power quality should be that of a
typical commercial or hospital environment.
IEC61000-4-5 ±2kV common mode differential mode
±0.5, 1, 2kV
common mode
Voltage dips, short <5% Ut (>95% dip in <5% Ut (95% dip in Mains power quality should be that of a
interruptions and Ut) for 0.5 cycle Ut) for 0.5 cycle typical commercial or hospital environment.
voltage variations If the user of the CoolGlide system requires
on power supply 40% Ut (60% dip in Ut) 40% Ut (60% dip in continued operation during power mains
input lines for 5 cycles Ut) for 5 cycles interruptions, it is recommended that the
CoolGlide system be powered from an
IEC61000-4-11 70% Ut (30% dip in Ut) 70% Ut (30% dip in uninterruptible power supply or a battery.
for 25 cycles Ut) for 25 cycles
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
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.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment: Guidance
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.
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.
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.
Operational Safety
WARNING
CAUTION
CAUTION
NOTE
WARNING
CAUTION
Always verify that the treatment parameters are correct before acti-
vating the laser.
CAUTION
Before placing the system in READY mode, confirm that the laser
handpiece aperture is safely positioned to prevent unintended laser
exposure.
CAUTION
WARNING
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
REF : xxxxxxxx
INVISIBLE
INVISIBLE LASER
LASER RADIATION
RADIATION –
–
SN : Xyyyyy
AVOID
AVOID EYE
EYE OR
OR SKIN
SKIN EXPOSURE
EXPOSURE TOTO
Mmmmm Yyyy DIRECT OR SCATTERED RADIATION
DIRECT OR SCATTERED RADIATION
Brisbane, CA
This product is covered Xxx-xxx V~, xx A, xx Hz Output:
Output: ≤≤ 100J
100J Max
Max at
at 1064nm
1064nm
by one or more of the Duration:
Duration: 0.1-300 ms
0.1-300ms
following U.S. and Class
Class 44 LASER
LASER PRODUCT
PRODUCT
corresponding foreign EC REP Per
Per IEC
IEC 60825-1:2007
60825-1:2014
patents and patent
applications: MDSS GmbH
Schiffgraben 41, D-30175
6,383,176 Hannover, Germany Complies
Complieswith
with21
21CFR
CFR1040.10
1040.10 and
and 1040.11
1040.11
6,485,484 except
except for
for deviations
deviations pursuant
pursuant to
to Laser
Laser
6,569,155 Notice
Notice No. 50, dated June 24, 2007
No. 50, dated June 24, 2007
5,595,568, 5,735,844
and 5,824,023
Certification
label
Site Preparation
Requirements
The family of CoolGlide laser systems is designed to require minimal site preparation. The fol-
lowing are specific electrical and space requirements:
• Electrical Requirements
CAUTION
• 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.
• Environmental Requirements
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 check-
list 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 customer-
provided door-switch cable can be connected (this will shut the laser down
when the treatment room door is opened during system operation). The treat-
ment room door must be closed in order to resume treatments. The laser sys-
tem must be powered ON and allowed to complete the power-on sequence.
• The warning sign provided with the laser system should be placed on the door out-
side 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.
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 unin-
tended exposure to laser radiation.
• 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.
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 com-
fortable 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 loca-
tion and allows for easy and effortless placement of subsequent treatment beams. The Cool-
Glide 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 pro-
fessional. The laser radiation emitted from the laser system can be harmful if proper proce-
dures 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
• 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 perma-
nently secured to both the laser and the handpiece and therefore, cannot be discon-
nected. The umbilical cable employs a rugged steel conduit that protects the fiber
optic cable and other components inside.
CAUTION
• Laser Aperture - Near the distal end of the handpiece is the recessed laser aper-
ture. A window protects the optical components inside the handpiece from damage
and contamination. Should this window become damaged or permanently contami-
nated, it should be replaced. Although replacement is not difficult, it should be
done only by a person properly trained on the procedure.
WARNING
CAUTION
• 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 epi-
dermis 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
• Treatment Guide - The treatment guides, extending from the contact cooling sur-
face, indicate the location of the current beam placement and provide easy and
accurate for subsequent beam placements. The CoolGlide Excel, CoolGlide Van-
tage 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 des-
ignated port location at the back of the system console.
WARNING
Control Panel/Buttons
Laser Status Indicator Icon - The laser status indicator icon illu-
minates yellow during the initial power-on and self test. The indi-
cator 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.
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 dis-
playing spot size and right justified when displaying the pulse
count.
System Specification*
Laser
Wavelength 1064nm
Physical Parameters
Operating length of
umbilical 77 in. (1.95 m)
Minimum bend
radius of umbilical Storage 5 in. (126 mm)
Momentary 2 in. (50 mm)
Electrical Requirements
Frequency 50/60 Hz
Humidity 0 - 90%
Classifications
Eye Safety
System Operation
The following section describes the user operation procedure for the family of CoolGlide laser
systems.
NOTE
System Start Up
WARNING
Before beginning each procedure, make certain that the patient and
all personnel are wearing appropriate protective eyewear. Unpro-
tected 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 posi-
tion (located on the rear of the laser console near the power cord).
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.
System Use
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.
NOTE
If the user decreases the pulse width to a value that causes the flu-
ence 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 con-
trol. 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.
5. Select the desired repetition rate by pressing the UP or DOWN buttons on the REPETI-
TION 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 treat-
ments where it is appropriate.
NOTE
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
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
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:
Display
On/Off Intensity
Number
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
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:
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 Aim-
ing 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.
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.
NOTE
11. Place the system in STANDBY mode by depressing the STANDBY button when treat-
ment 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 (parame-
ters used), prior to turning the system off.
3. Shut the laser down by turning the key to the OFF position or by depressing the EMER-
GENCY OFF button.
NOTE
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 spe-
cialties of general and plastic surgery and dermatology.
• 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 vas-
cularity is an integral part of the scar.
• Pregnant patients
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
• History of coagulpathies
• Diabetes
• History of herpes
• Accutane use
• History of vitiligo
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 sec-
tion, the following safety precautions are recommended during use of the laser system:
• 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 appropri-
ate 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 eye-
wear 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.
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.
• For treatment specific guidelines, refer to the Hair Removal Guidelines, the Vascu-
lar Treatment Guidelines, and the Non-Ablative Treatment Guidelines accompany-
ing this manual. These guidelines can also be obtained from your local Cutera
representative or online at www.cutera.com.
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: The building power (main electrical service) is turned off.
Solution: Turn on the building power.
Probable Cause: The laser’s main power circuit breaker is in the OFF position.
Solution: Place the laser’s main power circuit breaker in the UP
position.
Probable Cause: The building power (main electrical service) is tripped off.
Solution: Verify and/or turn on the building power.
Probable Cause: The laser’s main power circuit breaker is tripped to the OFF
position.
Solution: Place the laser’s main power circuit breaker in the UP
position.
Probable Cause: Remote interlock is in use and the treatment room door has
been opened.
Solution; Close the treatment room door and restart the system.
The laser does not emit laser energy although the laser is on.
The Handpiece status icon indicator is yellow with the green READY button blinking.
The footswitch icon is blinking green but the system icon is red.
Water Icon
Display shows “EEE” with the handpiece icon illuminated and a loud tone is heard.
Probable Cause: 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.
Solution: Move the spot size selection ring to the appropriate spot size
detent.
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).
User Maintenance
Use a cloth dampened with non-caustic cleaning solution, such as mild soap and water, isopro-
pyl alcohol, or a “hospital-grade” disinfectant, to wipe the external surfaces of the system con-
sole. Dry with a clean cloth, or allow to air dry.
WARNING
The recessed handpiece window is located at the distal end of the handpiece. Inspect the win-
dow 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
CAUTION
NOTE
Ejected hair from the patient can accumulate on the window, and
the window must be cleaned using the technique described below.
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 repre-
sentative (see Appendix E).
NOTE
Use only wood stick cotton swabs. Do not use products such as Q-
Tips as they contain an adhesive that dissolves when it comes in
contact with acetone.
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.
4. Inspect the window. If necessary, clean the window again with a new cotton swab.
NOTE
(Acceptable) (Unacceptable)
If the handpiece window is damaged or if debris cannot be cleaned off the window, replace the
window as described below.
2. Point the handpiece down towards the floor, and insert the window removal tool into the
handpiece aperture. Refer to the picture below.
3. Gently unscrew the old window and replace with a new window. Ensure that the hand-
piece is pointed down towards the floor while inserting the new window.
CAUTION
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
Clean the umbilical cable and handpiece housing as needed, using a soft cloth dampened with
mild detergent and water.
CAUTION
1. Sani-Cloth Plus and Sani-Cloth HB are registered trademarks of Professional Disposables International, Inc.
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 accumula-
tion.
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.
Fill Coolant
The CoolGlide laser systems require clean de-ionized/distilled water. Laser systems are deliv-
ered without any water in it and must be filled with de-ionized water upon installation. Occa-
sionally, de-ionized water may need to be added to top off the system.
CAUTION
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.
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
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.
5. Fill the plastic bottle and allow the coolant to flow into the CoolGlide cooling system. Use
only clean, unused de-ionized water provided.
6. Once the water stops flowing out of the fill bottle and into the system, turn the laser sys-
tem 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.
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
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.
11. Remove the plastic bottle completely out of the fill port.
12. Replace the fill plug into the fill port by hand.
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 instruc-
tions.
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 set-
tings. The following procedure should also be performed after any service or repair work.
Excessive vibration may necessitate more frequent calibration.
DISCLAIMER WARNING
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 (interna-
tionally).
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.
4. Start the system in service mode and using the Cutera Service software, place the system
in CALIBRATION mode.
6. Place the system User mode and verify the calibration using an external meter.
CAUTION
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”.
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
Symbols
This appendix describes the laser system symbols and their meanings.
Standard
Symbol Description Location
Reference
Standard
Symbol Description Location
Reference
Cutera-defined Footswitch status and footswitch Control panel and rear panel label
receptacle
Standard
Symbol Description Location
Reference
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 telangi-
ectasias. Dermatologic Surgery 2003; 29:56-8.
The Cutera family of CoolGlide laser systems utilizes state -of-the-art, self-diagnostic soft-
ware. 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).
Series 100 Codes - Series 100 Codes appear as a Code 120 - System operating under extreme conditions. Treat-
“warning” and typically will not hinder the treat- ment parameters or environmental conditions are less than
ment(s). Most Series 100 Codes are clearable by ideal.
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.
Series 200 Codes - Series 200 codes are “user clear- Code 250 - Footswitch is unplugged or an attempt was made by
able” faults and must be cleared in order to resume user to enter the READY mode while footswitch was
treatment(s). To clear, press either the READY or depressed. If unplugged, turn off system, plug in footswitch and
STANDBY button located on the control panel. If restart system. If attempt was made to enter READY mode with
after pressing the READY or STANDBY button, footswitch depressed, release footswitch and press the READY
the code does not clear, power off and re-start the button.
system.
Series 300 Codes - Series 300 codes indicate a “per- Code 322 - Water level in the system is low. Add de-ionized/
manent fault” and the system must be powered off distilled water only.
and restart in order to clear the code. If this fails to
clear the code, contact your local Cutera representa-
tive to schedule an appointment.
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