Candela GentleYAG User manual

Operator's
Manual
0123
8501-00-1766 Revision F
June 2006

GentleYAG Laser System Candela Corporation
8501-00-1766 Revision F CONFIDENTIAL Page 2
WARNING!
Use of controls or adjustments or performance of procedures other than those specified herein may
result in hazardous radiation exposure.
Federal (USA) restricts this device to sale by or on the order of a physician. Federal and other
international regulations also require that this device be utilized under the direction of a trained
physician.
This device should only be used by trained healthcare professionals authorized under applicable
local law to treat patients. All persons treating patients with this device should ensure that they are
authorized to treat patients under the applicable US State or applicable international laws.
(EC Authorized Representative)
Scanlan Group B.V.
Aalsmeerderweg 610
1437 EJ Schiphol-Rozenburg
The Netherlands
Phone: [phone] Fax: [phone]
Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886
Telephone [phone]
Toll Free [phone] (Technical Assistance)
Toll Free (800) 73-LASER (Customer Service)

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INDEX
Section 1……………………Application Description and Specifications.
Section 2……………………Hazards, Precautions and Safety Features.
Section 3……………………System Operation and Features.
Section 4……………………System Startup.
Section 5……………………Calibration Procedure.
Section 6……………………Maintenance/Troubleshooting and Delivery
System User Verification Tests.
Section 7……………………Labels and Symbols.
Section 8……………………Accessory List.
Section 9……………………Service Internal Calibration Procedure.

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Applications
Descriptions
Specifications
Section 1

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This manual provides operation instructions for the GentleYAG laser system with all
available spot sizes. The spot sizes included in your laser system depends on which
options were purchased. All GentleYAG Laser systems can be upgraded to include
all spot sizes. The following table lists all available spotsizes for the GentleYAG
Laser systems.
Laser System Spot size
(mm)
GentleYAG Laser System 1.5, 3, 6, 8, 10, 12,
15, 18
GentleYAG HR Laser 12, 15, 18
GentleYAG SRT Laser 6, 8, 10
GentleYAG VR Laser 1.5, 3
GentleYAG LE Laser System 3, 8, 12
The Candela GentleYAG Laser system is a flashlamp-excited, Nd:YAG
(Neodymium-doped Yttrium Aluminum Garnet) laser. Pulsed laser energy is emitted
at a nominal wavelength of 1064 nanometers (nm). This wavelength causes
maximum energy absorption by targeting specific chromophores in tissue In
addition, the laser pulse duration is controlled to be equal to or shorter than the
thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
Thisprinciple was first described by Anderson and Parrish (1).
APPLICATIONS
Table 1
-
0
GentleYAG Laser
System Spot Size

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For Instructions on the specific applications and the treatment parameters for each
indication please refer to the Treatment Guidelines for the GentleYAG Laser System
(Candela Part Number 8502-00-0867).
The GentleYAG Laser system,Figure 1-1, consists of an Nd:YAG laser controlled by
an embedded microprocessor. The user interface is an LCD panel with a touch screen
overlay. This allows the operator to select the laser operating parameters, initiate an
automatic calibration procedure and select DCD parameters.
The GentleYAG Laser System consists of an Nd:YAG laser head, a power supply and
a coolant water circulator. The laser head contains the cavity mirrors, solid-state
laser medium (Nd:YAG -Neodymium Yttrium Aluminum Garnet rod), and two high-
intensity xenon flashlamps that excite the laser medium. A calibration port with an
internal fluence meter is located centrally on the front of the laser. This
port is used to calibrate the output of the handpiece at selected fluence levels. The
circulation of coolant water at a controlled temperature regulates the temperature of
the laser head.
To provide energy to the flashlamp, a high-voltage power supply charges a storage
capacitor. Then, a high voltage switch transfers a portion of the energy from the
storage capacitor into the flashlamps. The resulting flash excites the Nd:YAG laser
rod, causing the emission of a pulse of laser energy.
DESCRIPTIONS
Laser System

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The systems deliver laser energy at a wavelength of 1064 nm with a pulsewidth of
250 microseconds to three hundred milliseconds. The output of the laser is delivered
to the area of treatment through an optical fiber with a treatment handpiece attached
to its distal end. A trigger (fingerswitch or footswitch) controls the delivery of
pulses. The laser delivers pulses at a rate of up to ten per second, depending on the
pulsewidth, rep rate and spot size setting.
The user selects the desired energy density (fluence) level, and enables or disables the
laser at the control panel.
The laser systems are equipped with interlocks that disable laser emissions if the
remote interlock circuit is open or the fiber is removed.
A green aiming beam is provided to illuminate the treatment area. The aiming beam
and treatment beam are dimensionally identical, so the aiming beam can be used to
accurately define the treatment pulse location. The aiming beam is illuminated when
the laser enters the Ready State.
The laser systems can be purchased with an optional skin cooling device referred to
as the dynamic cooling device (DCD). The DCD consists of an electrically controlled
spray nozzle located at the treatment end of the handpiece, a cryogen reservoir
canister and associated electronic control circuitry located in the top of the system
enclosure.
The cryogen, GentleCool™, is stored under pressure in the reservoir canister and
brought to the solenoid valve via tubing. When the DCD system is on, depressing the
Dynamic Cooling
Device (DCD)

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trigger switch will cause a burst of cryogen spray to be applied to the skin prior to or
after the laser pulse. Controls are provided on the laser front panel for the adjustment
of the spray burst duration and for the timing delay between the spray burst and the
laser pulse.

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FIGURE 1.1
LASER SYSTEM
Handpiece
Delivery
System
LaserSystem
Independent
Locking/Swivel
Wheels
Control
Panel
DCD
Canister

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Multiple handpiece delivery systems are offered with the laser system depending on
which options are purchased. The GentleYAG Laser System includes three delivery
systems (1.5/3 mm slider, 6/8/10 mm slider, 12/15/18 mm slider).Each delivery
system (Figure 1.2) consists of a cable assembly, replaceable distance gauge and a
handpiece assembly.
The cable assembly contains the fiberoptic, cryogen input line and valve control
wires. If the laser system is equipped with the optional DCD, the handpiece
assembly will contain the DCD spray nozzle, safety and detection electronics,
focusing lenses, and an output window to protect the lenses from dust and debris. The
spray nozzle is located near the distance gauge at the treatment end of the handpiece.
Handpiece
Delivery
System

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FIGURE 1.2
HANDPIECE
DELIVERY SYSTEM
Laser Aperture &
Distance Gauge
Location
Handpiece
Assembly
Cable Assembly
Valve
Control
Cryogen Line
Fiberoptic

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There are several different circular type distance gauges available for use with the
GentleYAG Laser System. The GentleYAG Laser System includes 5 types of amber
distance gauges and 4 types of black distance gauges. Each distance gauge is
designed to be used with respective spot sizes with the exception of the 8 mm
distance gauge. The 8 mm distance gauge should be used for both the 8 mm and 6
mm treatment spotsizes. It is important to use the correct distance gauge for the spot
size that the laser system is designed for.
The five types of amber distance gauges are for use with spot sizes from 6 mm to 18
mm. Each of the amber distance gauges also contains a window to offer extra
protection for the lenses in the handpiece. Removal and cleaning of the windows is
explained in section 6 of this manual.
WARNING
Use only distance gauges designed for the GentleYAG Laser System or damage
to the optical pathway will occur. These are distinguishable by the presence of
an exterior blue O-ring. The 1.5 mm distance gauges do not have an exterior O-
ring and are designed exclusively for GentleYAG LaserSystem. Refer to Figure
1.3.
Distance
Gauges

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The amber distance gauge is installed by inserting it,window end first, into the distal
end of the handpiece. Align one of the flat areas on the side of the distance gauge
with the spray nozzle and gently push until seated in the handpiece. To remove the
distance gauge, pull it straight out.
Note: A properly installed distance gauge has virually no gap between the distance
gauge and the distal end of the delivery system.
Note: The distance gauge does not rotate when installed.
Caution
DO NOT USE A SMALLER DISTANCE GAUGE WITH A LARGER
TREATMENT SPOTSIZE. THE LASER BEAM WILL PERMANENTLY
DAMAGE THE DISTANCE GAUGE. DO NOT USE A DISTANCE GAUGE
WITH VISIBLE SIGNS OF DAMAGE OR EXCESSIVE DETERIORIATION.
FIGURE 1.3
GentleYAG
DISTANCE GAUGE
(18 mm EXAMPLE)
BlueO-ring

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The four black distance gauges are for use with the 1.5mm and 3 mm spots only.
There are two types of distance gauges for each spot size and they are labeled on the
support leg similar to the amber distance gauges. Each spot size has a small and large
distance gauge with either a small or large treatment ring at the end. The large ring
offers increased visibility when the treatment area is relatively flat. The small ring
works better when the treatment area is on a curved surface or in close proximity to
protrusions.
The 3 mm distance gauge is inserted and removed from the handpiece using the same
technique as for the amber distance gauges. The 3 mm distance gauge does not have a
window in it. This is because the procedures associated with this spot size deliver less
energy to the treatment area and create much less debris. Note that there is a window
at the end of the 1.5/3 mm slider to keep the lenses in it clean. Figures 1.4 and 1.5
show the two types of 3 mm distance gauges.
The 1.5 mm distance gauge is significantly different from all the other distance
gauges. This distance gauge contains a lens and a window to help keep the lens
clean. Care must be used when handling this distance gauge to ensure that the lens
remains clean. The recommended method of holding the 1.5 mm distance gauge is by
grasping it firmly on the support leg. Figures 1.6 and 1.7 show the two types of 1.5
mm distance gauges

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FIGURE 1.4
GentleYAG
3 mm SMALL
DISTANCE
GAUGE
FIGURE 1.5
GentleYAG
3 mm LARGE
DISTANCE
GAUGE

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FIGURE 1.6
GentleYAG
1.5 mm SMALL
DISTANCE
GAUGE
FIGURE 1.7
GentleYAG
1.5 mm LARGE
DISTANCE
GAUGE

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The 1.5 mm distance gauge attaches to the delivery system in a different manner than
all the other distance gauges. Instead of inserting it into the handpiece slider tube, the
1.5 mm distance gauge is inserted directly onto the laser output end of the slider. This
end of the slider only protrudesout of the handpiece when the slider is adjusted for
the 1.5 mm spot. Figure 1.8 shows a close-up view of the small 1.5 mm distance
gauge before it is inserted into the handpiece slider.
FIGURE 1.8
1.5 mm SMALL
DISTANCE
GAUGE AND
HANDPIECE
SLIDER

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The proper method to install the 1.5 mm is as follows:
1. Grasp the distance gauge by the support leg.
2. Insert the distance gauge into the end of the slider while rocking it back
and forth once or twice. This will ensure that it is centered onto the slider
when installed.
To remove the 1.5 mm distance gauge, grasp the support leg and gently rock it back
and forth while pulling it out from the slider.
Caution
THE 1.5 MM DISTANCE GAUGES CONTAIN A BUILT-IN LENS AS PART
OF THE ASSEMBLY. THEY ARETHE ONLY DISTANCE GAUGESTHAT
SHOULD BE USED WHEN THE DELIVERY SYSTEM SLIDER IS
ADJUSTED FOR A 1.5 MM SPOT SIZE. USE OF ANY OTHER DISTANCE
GAUGE WILL RESULT IN AN INCORRECT SPOTSIZE AND THE
FLUENCE DELIVERED TO THE TREATMENT AREAWILL BE
INCORRECT.

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When the laser system is in the READY state, the aiming beam will illuminate. The
aiming beam should always be in or near the center of the distance gauge treatment
circle. The amber distance gauges and the 3 mm distance gauges are self aligning
when they are inserted in the delivery system.
The 1.5 mm distance gauge is not fully self-aligning so it may need to be readjusted
if the aiming beam is not near the center of the treatmentring.If this occurs, place the
laser in the STANDBY state and remove the distance gauge. Then reinsert the 1.5
mm distance gauge using one or two rocking motions as it is pressed onto the slider.
Recheck the centering of the aiming beam to verify that itis installed properly.
Caution
DO NOT USE A SMALLER DISTANCE GAUGE WITH A LARGER
TREATMENT SPOTSIZE. THE LASER BEAM WILL PREMANENTLY
DAMAGE THE DISTANCE GAUGE. DO NOT USE A DISTANCE GAUGE
WITH VISIBLE SIGNS OF DAMAGE OR EXCESSIVE DETERIORIATION.
Refer to Section 6 of this manual for instructions on cleaning and maintenance of
handpieces and distance gauges.