Candela MGY VPYAG Manual - 8501!00!1766

Operator's
Manual
0123
8501-00-1766 Revision F
June 2006
GentleYAG Laser System Candela Corporation
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: +31(0)20-653-0553 Fax: 31 20-653-3053
Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886
Telephone (508) 358-7637
Toll Free (800) 733-8550 (Technical Assistance)
Toll Free (800) 73-LASER (Customer Service)
8501-00-1766 Revision F CONFIDENTIAL Page 2

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.



Section 1
Applications
Descriptions
Specifications

This manual provides operation instructions for the GentleYAG laser system with all
APPLICATIONS 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 spot sizes for the GentleYAG
Laser systems.
Laser System Spot size

Table 1-0 (mm)
GentleYAG Laser GentleYAG Laser System
1.5, 3, 6, 8, 10, 12,
15, 18
System Spot Size 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.
This principle was first described by Anderson and Parrish (1).

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
DESCRIPTIONS 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
Laser System 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.

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
Dynamic Cooling 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
Device (DCD) 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
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.

Handpiece
Delivery
DCD System
Canister
FIGURE 1.1 Control

LASER SYSTEM Panel
Independent
Locking/Swivel
Laser System Wheels

Multiple handpiece delivery systems are offered with the laser system depending on
Handpiece 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
Delivery system (Figure 1.2) consists of a cable assembly, replaceable distance gauge and a
System 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.

Laser Aperture &

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

There are several different circular type distance gauges available for use with the
Distance 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
Gauges 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 Laser System. Refer to Figure
1.3.

FIGURE 1.3
GentleYAG
DISTANCE GAUGE
(18 mm EXAMPLE)
Blue O-ring
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.

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

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

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

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 protrudes out 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

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 ARE THE ONLY DISTANCE GAUGES THAT
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 SPOT SIZE AND THE
FLUENCE DELIVERED TO THE TREATMENT AREA WILL BE
INCORRECT.

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 treatment ring. 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 it is 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.

The GentleYAG Laser System is equipped with a fiber pole assembly to assist in
Fiber Pole supporting the weight of the delivery systems. The fiber pole is adjustable and can be
removed from the laser systems for easy storage.
Figure 1.9 shows the fiber pole attached to the laser system and ready for use. The
hook at the end of the fiber pole supports the delivery systems, but allows the fiber to
slide freely through it (to prevent kinks and bends). The black knob is used to lock
all three pivoting joints within the arm. To adjust the fiber pole, turn the black knob
counter clockwise and move the pole to the desired position. Tighten the black knob
clockwise to hold the fiber pole in position.
CAUTION
When using the fiber pole to support the delivery system, make sure there are
no sharps bends in the delivery system. The GentleYAG Laser System contains a
fiber optic cable that can be damaged if subjected to excessive bending. Never
pulse the laser system if the delivery system bend radius is less than six inches or
the optical fiber may be damaged.
The fiber pole may be folded for storage as shown in figure 1.10. Remove the fiber
from the hook and turn the black knob counterclockwise to loosen all the joints. Fold
the fiber pole and tighten the black knob clockwise to hold it in position.
To completely remove the fiber pole assembly from the laser, firmly pull the bottom
pole out of the two grommets on the side. There is a plastic cap at the base of the
pole. This cap should be reinstalled with the pole.
FIGURE 1.9
FIBER POLE
ASSEMBLY

FIGURE 1.10
FIBER POLE
FOLDED

The GentleYAG Laser System is equipped with wheels. The two front wheels are
LOCKING/ capable of swiveling, which makes parking in tight spaces easy.
SWIVEL The front swivel wheels contain levers, which stop the wheels from rotating. To
WHEELS prevent the laser from moving, the front wheels must be locked. To lock the front
wheels, depress the locking lever over each of the front wheels. To release, pull up
on the lever.
Table 1-1 Specifications for the GentleYAG Laser System.
SPECIFICATIONS Laser Type Flashlamp-excited, long-pulse Nd:YAG
laser
Wavelength 1064 nm
Table 1-1 Method of Optical Output Lens-coupled optical fiber to handpiece.
Specifications Maximum Delivered Energy per 80 J
pulse
Accuracy of Output Energy  20%
Pulse Repetition Rate Up to 10 Hz.
Pulse Duration 0.25-300 milliseconds
(100 ms max for LE systems)
Aiming Device Class 1 Laser Diode (per EN 60825-1),
520-550 nm, 5.0 mW
Treatment Spot Sizes (Diameter) 1.5, 3, 6, 8, 10, 12, 15, and 18 mm
(3, 8, 12 mm for LE systems)
Cooling Method Air to water heat exchanger
Dimensions (HxWxD) 35” x 16” x 28”

Weight 210 lbs (95 kg)

Cryogen HFC 134a
Table 1-1 Voltage and Current 220-230V 50/60HZ single phase 16A
Miscellaneous (per EN60601-1):
Specifications Type of protection against electric Class I equipment
Cont. shock
Degree of protection against Type “B”
electric shock offered by the
applied part
Sterilization method None required
Ingress protection Ordinary enclosed
Not “AP” or “APG” equipment
Regulatory The GentleYAG Laser System is a Class 4 laser product with a Class 1 aiming beam
per EN60825-1 Laser Hazard Classification. The GentleYAG Laser System is a Class
Classifications II medical device per FDA 21 CFR 878.4810, and a Class llb (Rule 9), non-invasive,
active device according to Annex lX of Directive 93/42/EEC.
GentleYAG comply with 21 CFR 1040.10 and

1040.11 except for deviations pursuant to Laser
Notice No. 50, dated July 26, 2001

ELECTRICAL REQUIREMENTS
ELECTRICAL
Table 1-2 lists Electrical Requirements for the GentleYAG Laser System.
REQUIREMENTS
CAUTION!
IF A PLUG OR LINE CORD NEEDS TO BE CHANGED, IT MUST BE DONE
BY A QUALIFIED PERSON IN ACCORDANCE WITH THIS SECTION AND
THE ELECTRICAL CODE OF THE INSTALLATION SITE.
The GentleYAG Laser System is shipped with a twelve foot (3.7 meter) power
cord terminated with a locking NEMA L6-30P plug for power connection in the
United States. The installation site requires a mating NEMA L6-30R power
receptacle located within ten feet (3 meters) of the intended laser system
location. See Table 1-2 for electrical service requirements.
For International installations, the power connections should be made with a
grounded 2-conductor plug and receptacle pair. The plug & receptacle must be rated
for the service line voltage at a minimum, and capable of handling 3680 VA (see
Table 1-2 for detailed ratings). A plug meeting these requirements must be installed
onto the laser system line cord. Alternately, the entire line cord may be replaced with
one which is terminated with the appropriate plug.

GentleYAG Laser System Electrical Requirements: 220 V - 230 V~, 50/60 Hz,
3680 VA
TABLE 1-2
ELECTRICAL Installation Site
Electrical Service Requirements
REQUIREMENTS
208 V - 240 V~, 60 Hz, 30 Amp, center-tapped, single phase,
United States
dedicated branch circuit with earth ground conductor.
220 V - 230 V~ (+/-10%) 50/60 Hz, >16 Amp*, single phase,

Worldwide
dedicated branch circuit with earth ground conductor.
*Note: GentleYAG Laser System may be suitable for hookup to

a 230 V~, 16 Amp dedicated service. Voltage dips and low line
conditions may cause the mains breaker to trip periodically.
The user should consult a qualified Electrician to verify mains
quality before connecting to a 16 Amp service.
GROUND CONTINUITY TESTS

Your laser system requires a connection to earth ground to reduce the risk of electric
shock. To verify that this safety feature is functioning properly, we recommend that
continuity between the laser chassis and mains plug grounding pin be checked
annually at a minimum, monthly if the laser is moved frequently, or before use if the
line cord and/or power plug has been altered or replaced. If you are unsure of which
pin is “ground” on your particular power plug, consult an Electrician for help. The
following procedure verifies ground continuity:
 Using the Ohms setting of a Volt-Ohm meter, set the scale to "x1". Measure the
resistance between the plug's ground pin and any unpainted conductive surface
on the laser chassis. This reading must fall between 0 - 0.1 Ohms.
 A battery & light or battery and buzzer combination may be alternatively used to
verify a ground connection between any unpainted conductive surface and the
plug's ground pin if an Ohmmeter is not available. An adequate ground
connection will be indicated by illumination of the light or sounding of the
buzzer.
Before installation of the GentleYAG Laser System, the intended site must be
ENVIRONMENTAL prepared as described in this section. The site must have sufficient space to
accommodate the laser system, must provide the proper electrical power
REQUIREMENTS configuration and receptacles, and must meet the additional environmental
specifications.
NOTE
Installation of the GentleYAG Laser System must be performed by a Candela
Service Representative. Following installation, a Candela Clinical Consultant
must instruct designated personnel on the basic operation and care of the laser.
An in-depth clinical training is required of a physician to become proficient in
the use of the GentleYAG Laser System.
NOTE
Treatment room areas associated with the use of cryogen require special
precautions. Refer to the Chemical Hazards paragraphs in section 2 of this
manual and the MSDS sheet (8501-00-1701) for further information.
Sufficient floor space is required for the laser system. Approximately 15

SPACE inches (40 cm) of clearance is required between the rear panel and the
wall, to allow room for the power cord and proper circulation of air
REQUIREMENTS from the cooling vents.
Humidity of 20% to 80% (non-condensing) should be maintained in the laser room.

Humidity
Ensure that the atmosphere is non-corrosive, with no salts or acids in suspension in
Air Quality the air. Acids, corrosives, and volatile materials are likely to attack electrical wiring
and the surfaces of optical components.
Keep air-borne dust particles to a minimum. Dust particles can cause permanent
damage to optical surfaces. Metallic dust can be destructive to electrical equipment.
Ambient A temperature between 65° and 85°F (18° and 29°C) should be maintained in the
Temperature laser room during operation.
Avoid placing the laser system near heating outlets or other sources of air currents
Relocation that could cause uneven cooling in the laser system. Care should always be taken
when moving the GentleYAG Laser System. Remove the footswitch tubing from the
connector (located in the rear of the laser) before moving. Guide the GentleYAG
Laser System by grasping the left and right side edges of the front bezel or guide
using the rear handle. Take special care when maneuvering over thresholds, elevator
doors, ramps, and other uneven or sloping floor surfaces. A severe physical shock
could cause the alignment of the laser head or the optical fiber to be disturbed
resulting in personal injury or physical damage.
If it becomes necessary to relocate the GentleYAG Laser System, call Candela

Customer Service or your distributor for details. Failure to do so may result in
damage to the system, and may void any warranty.
Mobile Use The GentleYAG Laser System is not designed for mobile use.
Transport & For transport and storage of GentleYAG Laser System, the temperature must be kept
between 40° and 110° F (4.5° and 43° C), and humidity between 20% and 80% (non-
Storage condensing). Ambient atmospheric pressure is suitable with no restrictions.
WARNING
DO NOT EXPOSE TO TEMPERATURES BELOW 4.5°C OR DAMAGE
MAY OCCUR. IF LASER IS EXPOSED TO TEMPERATURES BELOW
4.5°C, CONTACT CANDELA TECHNICAL SUPPORT PRIOR TO USE.

Section 2
Hazards
Precautions
Safety Features

1. Identify the laser room clearly. Post appropriate warning signs in

LASER ROOM prominent locations at all entrances to the laser room.
2. Cover all windows, portholes, etc. with opaque material to prevent
PRECAUTIONS unintended viewing or laser light escaping from the laser room.
3. When the GentleYAG Laser System is in operation, restrict entry and limit
access to the laser room to those personnel both essential to the procedure
and well trained in laser safety precautions.
4. Make sure that all laser room personnel are familiar with the laser system
controls and know how to shut down the laser system instantly in an
emergency.
CAUTION!
The use of flammable anesthetics or oxidizing gases such as nitrous oxide and
oxygen should be avoided. The high temperature produced during normal use
of the laser equipment may ignite some materials, for example cotton or gauze
pads when saturated with oxygen. The solvents of adhesives and flammable
solutions used for cleaning and disinfecting should be allowed to evaporate
before the laser equipment is used. Attention should also be drawn to the danger
of ignition of endogenous gases.

Hair, gauze, masks, cannula and airway materials can be ignited by laser energy in an
FLASH FIRE oxygen-enriched atmosphere even if thoroughly soaked with saline. The following
scenario can lead to a flash fire during laser treatment:
HAZARDS 1. Oxygen is administered via a mask, endotracheal tube, or nasal cannula.
Leakage of oxygen generally occurs near the eye region where a tight seal
of the mask is difficult to maintain, near the nasal area when a cannula is
used, or near the mouth when an endotracheal tube is used.
2. An oxygen-rich atmosphere is created and dissipates over the face.
Transient local concentrations of oxygen can greatly accelerate
combustion.
3. During treatment, the laser beam strikes combustible material, which
absorbs the laser energy, and the material is heated above its combustion
point. This may occur simply by singeing the tip of a single dry hair.
4. This momentary, and possibly unnoticeable, ignition sets off a more
significant flash fire. The fire then follows a path from the peripheral area
of the oxygen enriched atmosphere to the oxygen source.
5. Other combustible substances are involved as a secondary effect of the
initial ignition and may be related to hair, gauze, oxygen delivery devices,
anesthesia gases, or byproducts of anesthesia in the oxygen enriched
atmosphere. A burn may then occur where this secondary effect is present.

CAUTION!
THE ELECTRICAL AND LASER RADIATION HAZARDS PRESENT
DURING SERVICING OF THE GENTLEYAG CAN BE EXTREMELY
DANGEROUS AND SHOULD BE SERVICED ONLY BY THOSE
QUALIFIED TECHNICIANS WHO HAVE RECEIVED
APPROPRIATE TRAINING ON THE GENTLEYAG FROM
CANDELA.
CAUTION!
USE ONLY SAFETY EYEWEAR WITH AN OPTICAL DENSITY OF
OPTICAL  6.3 @ 1064 NM.
PRECAUTIONS The laser beam emitted by the GentleYAG Laser System is capable of causing loss of
vision. The laser operates at 1064 nm, which falls within the invisible, near-infrared
region of the electromagnetic spectrum. While not visible to the eye, it is still capable
of inflicting damage. Remember this and take precautions to avoid inadvertent
exposure. The cornea and lens of the eye are transparent to invisible light. Any
energy emitted by the GentleYAG Laser System that enters the eye will be focused
directly on the retina. Direct contact of the laser beam on the retina can cause

temporarily clouded vision, retinal lesions, long-term scotoma (vision absence in an

isolated area), long-term photophobia (sensitivity to light) and/or loss of vision.
The laser aperture of the GentleYAG Laser System is at the distal end of the
handpiece. The beam enlarges as distance from the handpiece increases. The
Nominal Ocular Hazard Distance (NOHD) is the distance at which the beam is so big
it is no longer dangerous to the unprotected eye. This distance along with the full
angle beam divergence for each handpiece is shown in the following table.
To avoid vision hazards, everyone within the NOHD (see Table 2-1) of the
GentleYAG Laser System must wear appropriate eye protection. Protective eyewear
is supplied with each laser, and is available from a variety of vendors including
Candela.
Handpiece Slider NOHD(m) per

Table 2-1 Spot Size
Full Angle Beam
EN60825-
Divergence
NOHD/ Handpiece 1:2002
1.5-3 mm slider at 1.5 mm 0.224 16.3
Comparison 1.5-3 mm slider at 3 mm
0.082 78.1
and 3mm LE
6-8-10 mm slider and
0.071 190
8mm LE
12-15-18 mm slider and
0.079 172
12mm LE

Maximum delivered energy per EN60825-1:2002 is 96 J.
CAUTION!
THE LASER BEAM EMITTED BY THE GENTLEYAG SHOULD
NEVER BE DIRECTED AT ANY PART OF THE BODY OTHER
THAN THE INTENDED SITE OF TREATMENT OR TESTING.
Follow these precautions to ensure optical safety:

Optical Safety 1. Appoint one person responsible for the laser system controls during the
Precautions procedure.
2. Ensure that all personnel wear appropriate safety eyewear whenever the laser
system is on.
3. Never look directly into the laser beam even when wearing protective eyewear.
4. Never allow the laser beam to be directed at anything other than the targeted
area or the calibration port.
5. Never permit reflective objects such as jewelry, instruments or mirrors to
intercept the laser beam.

6. When the GentleYAG Laser System is not in use, place it in STANDBY state to
prevent accidental pulsing.
7. When the GentleYAG Laser System is unattended, remove the key from the
keyswitch to prevent unauthorized use.
The GentleYAG Laser System converts and amplifies the AC line voltage to produce
ELECTRICAL extremely high voltages inside the laser system that may be lethal. It is possible for
high-voltage components to retain a charge after the power supply has been turned
& MECHANICAL off, and even after the GentleYAG Laser System has been disconnected from the line
voltage. Therefore, no part of the exterior housing should be removed, except by a
HAZARDS trained and authorized technician.
The GentleYAG laser delivery systems utilize fiber optics that can be damaged if
installed or subjected to excessive bending. To avoid damage to the optical fiber,
limit bends to a radius of 6 inches (15 cm) or greater. Failure to follow recommended
procedures may lead to damage to the fiber or delivery system and/or harm to the
patient or user.
To prevent the laser from moving, both front wheels must be locked. To lock the
wheels, step down on the tabs on the front of the wheels. To unlock, pull up on the
extending tab.
The GentleYAG Laser System weighs approximately 210 pounds (95 kg) and may
cause injury if proper care is not used when moving it. The system should always be
moved carefully and slowly.

CHEMICAL There are no known chemical hazards associated with the GentleYAG Laser System.
Hazards The laser system uses a Hydroflourocarbon (HFC), cryogen, in the optional Dynamic
Cooling Device (DCD).
Cryogen Inhalation: If high concentrations are inhaled, immediately move to fresh air. Keep
person calm. If not breathing, give artificial respiration. If breathing is difficult, give
oxygen. Call a physician.
Skin Contact: If large amounts of cryogen contact the skin due to a leak or rupture in
the cryogen system flush skin immediately with water and call a Physician to check
for frostbite. Treat for frostbite if necessary by gently warming affected area.
Eye Contact: In case of eye contact, immediately flush eyes with plenty of water for
at least 15 minutes. Call a Physician.
Ingestion: Ingestion is not considered a potential route of exposure.

NOTE: To Physicians
Because of possible disturbances of cardiac rhythm, catecholamine drugs, such
as epinephrine, should only be used with special caution in situations, when
performing emergency life support. See MSDS sheet 8501-00-1701.

Guidelines for Cryogen Treatment Areas
Treatment room areas associated with the use of Gentlecool products (cryogen)
require special precautions, since there is a possibility of cardiovascular
sensitivity in high concentration situations and frostbite hazards from an
abnormal discharge of the product.
The objective is to maintain a cryogen concentration level in the treatment area

below 1000 ppm. This is accomplished by balancing the size of the treatment area,
amount of ventilation, and duration of cryogen spraying.
General Treatment Area Guidelines:
 Minimum treatment area size should be 40 sq ft. ( 5 ft x 8 ft) – based on an

8 ft ceiling
 Any treatment area smaller than 513 sq ft ( but larger than 40 sq ft) should
have a 130 CFM (cubic feet per minute) (or higher) fan in use during
treatments with cryogen. It should be used in an exhaust mode. Since
cryogen is heavier than air, it will settle toward the floor. If at all possible,
have the exhaust fan low rather than at ceiling height. A smoke evacuator
is not a substitute.

 All treatment areas should have cross ventilation. At least one ventilation
opening should be at floor level. If at all possible one ventilation opening
should be to outdoors. Both opening sizes should be approximately the
same area.
 Refer to MSDS sheet (8501-00-1701) for further information.
Frostbite Risks:
Treatment areas should have sufficient free floor space to allow a patient or user the
ability to move away from an unanticipated spray of cryogen. The following table
gives some exposure guidelines:
Visual outer edge of Hand detection of outer

spray edge of spray
Direct release from 27 inches 31 inches
canister
Release from tip of 19 inches 23 inches

handpiece
For specific customer situations contact Candela Technical Support.

Treatment Area:
FIRE HAZARD Never use any flammable substance, such as alcohol or acetone, in the preparation of
the skin for treatment. Use soap and water, if necessary.
Anesthetics:
Anesthetics administered either by inhalation or topically must be approved as non-
flammable.
Instruments:
Since laser beams are reflected by most shiny surfaces, all instruments used in laser
procedures should have brushed, burnished, or blackened, non-reflective surfaces.
Laser Fiber Fire Hazard:

GentleYAG Laser System fibers carry significant laser energy. If the fiber were to
break during laser pulsing, a sudden flash or flame may be observed at the break
point. This flash or flame with each pulse will continue until pulsing is stopped.
Individuals in contact with this flash or flame could receive a burn. Ignition of
combustible materials (including clothing) in the proximity of the fiber break could
also occur.
If a break, or a sudden flash or flame is observed in the fiber, discontinue pulsing

immediately.

Because a break could occur suddenly, always position the fiber during each use such
that it is in full view. For example, do not drape the fiber over the shoulder or around
the back, leaving a portion of the fiber out of view during use.
Do not lay the fiber across combustible materials during use.
Do not drape the fiber over the shoulder or back or place it on combustible material.
Laser plume may contain viable tissue particulate.

LASER Please reference the American National Standard for Safe Use of Lasers (ANSI
GENERATED AIR A136.3.-2005), section 7.3 Laser Generated Air Contaminants (LGAC).
CONTAMINANTS Some mechanism for decreasing LGACs should be used. Based on the type of
condition being treated by the laser, there may be a higher incidence of LGAC.
(LGAC)
Reference the NIOSH Hazard Controls: Control of Smoke from Laser / Electrical
Surgical Procedures bulletin (HC11) -- US Department of Health and Human
Services, Public Health Service: National Institute for Occupational Safety and
Health, September 1996.
NIOSH has shown that airborne contaminants generated by laser use can be
effectively controlled by proper ventilation and work practices. (The thermal
destruction of tissue creates smoke byproduct, which can contain a variety of gases,
vapors, dead and live cellular material, including blood fragments.)

When removing hair, shave excess hair away before beginning laser treatment to
reduce odor and char.
The GentleYAG Laser System has been designed to comply with IEC/EN 60601-1-2
ELECTRO- (Group 1, Class A) "Electromagnetic Compatibility Requirements and Tests". Class
A equipment is intended for use in commercial and industrial locations. A portion of
MAGNETIC IEC/EN 60601-1-2 deals with measurements of unwanted radio frequency emissions
INTERFERENCE generated from a product. Both radiated emissions (radiated through the air) and
conducted emissions (conducted into the AC Mains) are measured. Radiated and
conducted emissions from a product have been known to interfere with the
performance of other equipment in the vicinity. The emissions from the GentleYAG
Laser System have been reduced as far as practical without compromising
functionality.
If interference from the GentleYAG Laser System is suspected, ensure that the unit is
plugged into an AC Mains that is not shared by the affected equipment. If the
interference still exists, move the GentleYAG Laser System or the affected equipment
into another room.
Refer to accompanying Declaration and Guidance document (part number 8501-00-
1736) for additional information and guidance.
Warning
When treating patients with this laser system and using the Dynamic Cooling Device
(DCD) feature in conjunction with an ECG monitoring device attached to the patient,
interference with the ECG monitoring device may result.

Keylock Switch
SAFETY This key-operated switch controls electrical power to the laser system. The
FEATURES GentleYAG Laser System can be operated only with the key provided by Candela.
The key should be removed from the keyswitch when the laser is not in use.
Laser Emergency Stop Switch

STOP
When the red switch with this label underneath (located on the lower left side
of the control panel) is pressed, the GentleYAG Laser System is shut down
immediately.
PFN Charged
An audible beep will be heard when the laser is ready to deliver a pulse of energy.
Lasing
An audible beep will be heard and the control panel flashes three Lasing Triangle
symbols to indicate that the laser is releasing laser energy.
Ready Lamp
The blue lamp mounted near the control panel is illuminated when the laser is in the
Ready state.

STANDBY and READY Operating States

The system operates in one of two states: STANDBY or READY. In the STANDBY
state, laser emission is disabled. The operator must put the system into the READY
state in order to enable laser emission. In the READY state, laser pulses are generated
by depressing the trigger switch. As a safety precaution, there is a delay of two
seconds from the time that the system enters the READY state to the time that laser
emission is enabled. When the laser system is not being used, it should be returned to
the STANDBY state. The laser will automatically revert back to the STANDBY state
after 2 minutes of inactivity in the READY state. The operator selects the operating
state via the Display Panel. System state information is also displayed on the Display
Panel. When the system is in the READY state, the blue lamp to the right of the
Display Panel is illuminated.
Remote Interlock
An external connector for a remote interlock switch is provided on the back of the
system enclosure. This interlock switch can be connected to the doors of the laser
room. If the door is opened and the GentleYAG Laser System is in the Ready state,
the laser system completely shuts down. For more information on installation of a
remote interlock, please call Candela Service
Note: The interlock must be in position to operate the device.

Residues that accumulate on the delivery system windows and distance gauge during
ENVIRONMENTAL normal use may contain infectious viable tissue particulate. Under certain conditions,
contact with viable tissue particulate can put a user at risk for contracting disease.
PROTECTION Therefore at the end of its useful life, the distance gauge, windows & cleaning
materials should be disposed of in a way that minimizes risk of exposure. Such
methods of disposal include, but are not limited to, disposal in a biohazard container
Disposal (if available), incineration, or disposal as sealed waste in a plastic bag discarded with
regular trash. Non-porous gloves should be worn during treatment and when
Hazards & servicing patient-contact parts to reduce risks associated with exposure. The gloves
should be disposed of in the same manner as contact parts.
Guidance Other than patient-contact parts, all external components & accessories can be
disposed of as regular trash. Most internal components that make up the laser system
can also be disposed of as regular trash with the exception of the high voltage
capacitor and an integrated battery located on the laser I/O printed circuit board.
The high voltage capacitor must be disposed of through a hazardous waste company
because of two potential hazards:
1. Shock hazard – Once removed from the system the capacitor can
accumulate a potentially lethal charge.
2. Dielectric oil – The oils used in the high voltage capacitor, silicon or
soybean, are not considered hazardous, but must be disposed of in a manner
consistent with local regulations.
Batteries:
An IC located on the Laser I/O printed circuit board (beneath front cover) contains an

integrated Lithium-ion battery, which is not replaceable or user-serviceable. The IC

designated “U7” must be removed and disposed of separately from the laser system
in accordance with local disposal laws regulating battery disposal.
The fluid in the coolant circulation system contains distilled water and can be
disposed of as regular water.
If disposal of the laser system or its accessories becomes a problem in your area,
contact Candela for instruction.
Hazardous Material & Hazardous Waste

If the laser system includes a DCD option, the GentleCOOLTM canister is classified
as “hazardous”. Refer to the following matrix:
Item Hazardous category Comments
GentleCOOLTM Pressure Must be disposed of as
canister hazardous waste or shipped as
hazardous material.
A canister may be vented to
empty and then be disposed of in
the trash as “non hazardous”
Refer to associated Material Safety Data Sheets (MSDS) for further information on
safety, handling, first aid and disposal.


Section 3
System Operation
& Features

The GentleYAG Laser System control panel (Figure 3.1) located on the front of the
laser system, consists of an On/Off Keylock switch, a Laser Stop (emergency off)
push-button switch, Ready Lamp, Calibration Port, Handpiece Delivery System
Receptacles, and a Touch Screen Display Panel (Display Panel). The Display Panel
(Figure 3.2) provides a simple graphical user interface for the operator. The operator
uses this interface to select the system operating state, laser operating parameters,
DCD parameters and output energy calibration.
Valve
Calibration Control
Port Receptacle
“Cal Port”
Figure 3.1 Cryogen
Line
Control Panel Display
Receptacle
Panel
Fiberoptic
Laser Stop Receptacle
Switch
On/Off
Keylock Ready
Switch Lamp

Keylock Switch
This key-operated switch controls electrical power to the laser system. The
GentleYAG Laser System can be operated only with the key provided by Candela.
The keylock switch has three positions: “ ” (off), “ ” (on), and “ ” (start). To
start the laser, turn the key from the “ ” position to the “ ” position, then release.
The switch spring returns to the “ ‟‟ position. The laser system starts in a few
seconds and four quick audible beeps will sound.
Laser Stop Switch

When the red Laser Stop switch is pressed, the laser system shuts down immediately.
To restart the system, turn the keylock switch to the “ ” position, and then release.
Laser Aperture
The laser aperture is located at the distal end of the handpiece (see Figure 6.3).

Ready
Adjust Up
Figure 3.2 Button
Laser State
Display
Button
Touch Screen Standby
Display Panel Button
DCD
Pre Spray
Fluence
Duration
Main Screen Button Button
Pulse width DCD

Select Delay
Button
Repetition rate
Select DCD Post
Spray
Duration
Spotsize Button
Identification Canister
& PURGE Counter
Button
Next
Adjust Screen
Down Calibrate Button
Button Button

Figure 3.3
Next Screen
Aiming Beam
Intensity Pulse Count
and Reset
Button
Triggerswitch
Select
Language
Select
Spot Size
Identification
& PURGE
Button
Calibrate Next
Button Screen
Button

Figure 3.4
Laser Variable
Mode
Laser Variable Mode (LVM) is a read-only display of system parameters. This screen
should not be used during normal operation of the laser. It is used to assist service
personnel in trouble-shooting the laser. The laser system can not be pulsed in this
mode. LVM is accessed by depressing and holding the Next button until the LVM
screen appears. LVM can be exited by one of the following: the next button, cycle
system power, or pulse the laser (if in READY). Note: The contents of this screen
may vary and is shown for reference only.

Handpiece Placement: In-use Handpiece Placement: Storage

Figure 3.5
Handpiece Basket
The handpiece basket

provides convenient
handpiece storage. The
basket has two positions: in-
use & storage. The in-use
position allows the user a
quick convenient place to
park the handpiece while in-
use. The storage position
(rear basket slot) is designed
to remove excess slack from
the delivery system. This
reduces the risk of damage
to the delivery system while
not in use.

The system state status is located in the center, top section of the display. The system
SYSTEM STATE operates in one of two states: STANDBY or READY.
When in STANDBY, the high voltage power supply is turned off and laser emission
Standby is disabled.
The operator selects the STANDBY state by pressing the STANDBY button. The
background for the Standby button is set to BLACK to indicate that this state is
selected. The word “STANDBY” is also displayed in the top portion of the Display
Panel.
The GentleYAG Laser System automatically enters STANDBY state following the
initial warm-up period, which occurs when the laser system is first powered up.
If the laser has been inactive in the READY STATE for two minutes or if a fault
condition is detected, the system reverts to the STANDBY state automatically.
CAUTION!
DO NOT ENTER THE READY STATE WITHOUT A FIBER
INSTALLED.
Ready
When in READY the high voltage power supply is turned on, the beam shutter is
opened, the aiming beam is illuminated, and laser emission is enabled.

This state is selected by pressing the READY button. The background for the title
text of the READY button is set to BLACK to indicate that this state is selected. A
two second delay is implemented before laser emission is enabled when the system
state changes from STANDBY to READY as a safety precaution.
The blue Ready indicator, “ ”, located below the control panel display is
illuminated when the laser is in the READY state. See Section 7 for the location of
the Ready indicator.
The window area below the System Status menu bar contains the buttons associated
with the Main Menu.
The laser operating parameters can each be set individually by the operator. To
OPERATING change a parameter, press the appropriate button and use the up or down arrows to
adjust the value to the desired setting. The background for the selected parameter is
PARAMETERS set to black to indicate that their numeric settings can be modified.
To ensure that the selected energy density is delivered accurately, the laser will
Fluence automatically require that a calibration procedure be performed if the Fluence
parameter has been changed. For safety purposes, the Fluence parameter will always
default to the lowest fluence for a given spot size when the laser is turned on.

NOTE
The Fluence parameter is the amount of energy density delivered to the selected spot
size. The Fluence setting is adjustable in various increments of J/cm2 for different
spot sizes as shown in the following tables (3.1 to 3.8). To calculate the energy from
the handpiece in Joules, multiply the fluence by the area (  r 2) for the spot size
selected.
The Pulsewidth parameter adjusts the duration of the laser pulse. The available
Pulsewidth pulsewidths for the fluences and spot sizes selected are indicated in Tables 3.1 to 3.8.
Repetition The “Repetition Rate” is a user selectable parameter on the front panel. It limits the
speed of the laser pulsing (in HZ) to the maximum rate selected, thereby allowing the
Rate user to best maintain control during the treatment. The product has the following
“Repetition Rate” selections: 0 HZ (single pulse mode) and the multi-pulse modes,
.5HZ, 1 HZ, 1.5 HZ, 2 HZ, 3 HZ, 5 HZ, 7HZ and 10 HZ. In multi-pulse mode, the
laser will pulse at a steady rate as long as the delivery system‟s trigger is depressed.
Not all selections are available. The availability of the selections depends on the
combination of other parameters selected (spot size, fluence, and pulse width). Refer
to Tables 3.1 to 3.8 for available selections. Note: The actual repetition rate observed
during pulsing may be slower than the “Repetition Rate” selected and displayed on
the front panel. The displayed value is intended to represent a maximum pulse
“Repetition Rate”. The “Repetition Rate” will never exceed the displayed setting on
the display panel.

Table 3.1 Available Fluence Settings for the 1.5 mm Spot (J/cm2)
1.5 mm Fluence, 200 300 380 460 540
220 320 400 480 560
Pulsewidth, 240 340 420 500 580
Repetition Rate 260 360 440 520 600
280
Ranges
Notes:
1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, 1.5 and 2.0 for all fluences.
The repetition rate setting is a maximum setting. The actual repetition rate
achieved may be less depending on selected fluence, pulsewidth and DCD settings.
2. Pulsewidth can be set from 10 ms to 100 ms in 10 ms increments and from 125 ms
to 300 ms in 25 ms increments. Longer pulsewidths reduce the achieved repetition
rate.

Table 3.2 Available Fluence Settings for the 3 mm Spot (J/cm2)

50 110 170 260 380
3 mm Fluence, 60 120 180 280 400
Pulsewidth, 70 130 190 300 420
80 140 200 320 440
Ranges 100 160 240 360
Notes:
1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, and 1.5 for all fluences. The
repetition rate setting is a maximum setting. The actual repetition rate achieved
may be less depending on selected fluence, pulsewidth and DCD settings.
2. Pulsewidth can be set from 10 ms to 100 ms in 10 ms increments and from 125 ms
to 300 ms in 25 ms increments. Longer pulsewidths reduce the achieved repetition
rate. 100 ms maximum for LE.

Available Maximum
Minimum Maximum
Pulsewidths Repetition Rate
Table 3.3 (ms)
Fluence (J/cm2) Fluence (J/cm2)
(Hz)
6 mm Fluence, 0.25 6.0 23.0 7 (note 2)
0.30 6.0 27.0 10 (note 2)
Pulsewidth, 0.35 6.0 30.0 10 (note 2)
Repetition Rate 0.40 6.0 30.0 10 (note 2)
0.45 6.0 30.0 10 (note 2)
Ranges 0.50 6.0 30.0 10 (note 2)
3.0 35.0 200.0 2 (note 4)
5.0 35.0 200.0 2 (note 4)
10 to 100
(10 ms 35.0 200.0 2 (note 4)
increments)
125-300
(25 ms 35.0 200.0 2 (note 4)
increments)
Notes:
1. Fluence increments are 1 J/cm2 from 6 to 30 J/cm2 and 5 J/cm2 from 35 to 200
J/cm2.
2. Maximum Repetition Rate = 3 Hz for 6 -11 J/cm2, 5 Hz for 12-20 J/cm2, 7 Hz for
21-23 J/cm2, 10 Hz for 24 -30 J/cm2
3. The repetition rate setting is a maximum setting. The actual repetition rate
4. The maximum repetition rate is 1.5 Hz at fluences greater than 110 J/cm2 with a 3
ms pulsewidth. Longer pulsewidths reduce the achieved repetition rate.
0.25 6.0 13.0 7 (note 2)

0.30 6.0 15.0 10 (note 2)
0.35 6.0 18.0 10 (note 2)
Table 3.4 0.40 6.0 20.0 10 (note 2)
0.45 6.0 20.0 10 (note 2)
8 mm Fluence, 0.50 6.0 20.0 10 (note 2)
Pulsewidth, 3.0
5.0
35.0
35.0
150.0
150.0
2 (note 4)
2 (note 4)
Repetition Rate 10 to 100
35.0 150.0 2 (note 4)
Ranges (10 ms increments)
125-300
(25 ms increments) 35.0 150.0 2 (note 4)
Non LE System
Notes:
J/cm2.
2. Maximum Repetition Rate = 3 Hz for 6 J/cm2, 5 Hz for 7-11 J/cm2, 7 Hz for 12-13
J/cm2, 10 Hz for 13 -20 J/cm2

Available Maximum
Minimum Maximum
Pulsewidths Repetition Rate
Fluence (J/cm2) Fluence (J/cm2)
(ms) (Hz)
Table 3.5 0.25 6.0 8.0 7 (note 2)
0.30 6.0 10.0 10 (note 2)
10 mm Fluence, 0.35 6.0 11.0 10 (note 2)
Pulsewidth, 0.40 6.0 12.0 10 (note 2)
0.45 6.0 12.0 10 (note 2)
Repetition Rate 0.50 6.0 12.0 10 (note 2)
Ranges 3.0 35.0 100.0 2 (note 4)
5.0 35.0 100.0 2 (note 4)
10 to 100
(10 ms 35.0 100.0 2 (note 4)
increments)
125-300
(25 ms 35.0 100.0 2 (note 4)
increments)
Notes:
J/cm2.
2. Maximum Repetition Rate = 5 Hz for 6-7 J/cm2, 7 Hz for 8 J/cm2, 10 Hz for 9-12
J/cm2.

10 22 34 46 58
12 mm Fluence, 12 24 36 48 60
Pulsewidth, 14 26 38 50 62
16 28 40 52 64
Ranges 20 32 44 56 68
70
Notes:
1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, 1.5, and 2.0 for all fluences.
2. The available pulsewidth settings for each fluence are: 3 ms, 5 ms, 10-100 ms (in
10 ms increments), and 125 ms to 300 ms (in 25 ms increments). 100 ms
maximum for LE.


6 12 22 34
15 mm Fluence, 7 14 24 36
Pulsewidth, 8 16 26 38
9 18 28 40
Repetition Rate 10 20 30 42
Ranges 32 44
Notes:
10 ms increments), and 125 ms to 300 ms (in 25 ms increments).


6 10 18 26
18 mm Fluence, 7 12 20 28
Pulsewidth, 8 14 22 30
9 16 24
Repetition Rate
Ranges
Notes:
10 ms increments), and 125 ms to 300 ms (in 25 ms increments).

The following operating parameters will only be displayed when the optional
Dynamic Cooling Device is installed.
The DCD Pre Spray Adjust parameter adjusts the duration of the cryogen spray
DCD Pre Spray applied to the patient before the laser pulse. The DCD Pre Spray can be turned off
(“O”) or set to a duration from 20 milliseconds to 100 milliseconds in increments of
10 milliseconds. The 1.5/3 mm delivery system can access three additional pre-spray
settings of 10, 15, and 25 ms. Also, to access pre spray times above 30 ms with this
delivery system, hold down the UP arrow on the display for at least 5 seconds.
CAUTION
DCD spray is not allowed at rep rates greater than
2 Hz.
The DCD Delay Adjust parameter adjusts the duration of the time between the DCD
DCD Delay cryogen spray and the laser pulse. The delay selectable range is 3, 5, 10-150
milliseconds, in increments of 10 milliseconds.

The DCD Post Spray Adjust parameter adjusts the duration of the cryogen spray
DCD Post Spray applied to the patient after the laser pulse. The DCD Post Spray can be turned off
(“O”) or set to duration between 10 and 50 milliseconds, in increments of 10
milliseconds.
When the DCD Pre or Post Spray Adjust parameters are changed, the canister counter
is updated to reflect the change.
The Canister Counter is a decrement counter that keeps track of the number of
Canister Counter/ cryogen spray pulses contained within a canister. The count decrements with each
pulse of the laser if the DCD is in the “ON” state. When the count reaches zero, the
Reset message “REPLACE CANISTER” appears and the canister must be replaced. Use of
a canister after the counter reaches zero may result in inadequate canister pressure,
and therefore, inadequate cryogen spray. Any residual cryogen left in the canister is
there as a margin of safety for both you and your client. Instructions for replacing the
canister are shipped with each canister. Install only new, full cryogen canisters.
Installation of a partially used canister will cause the canister count to be incorrect.
Once the new canister is installed, the canister counter must be reset. This is done by
holding the canister counter button down for several seconds until a new count
appears. The canister counter is updated when spray duration is changed, and with
each pulse of cryogen including purges. Canister counts for each of the combined Pre
and Post Spray durations are shown in tables 3.9 and 3.10.

Spray Duration Pulses Available Pulses Available

Table 3.9 (ms) (Post Spray = 0) (Post Spray = 50)
Cryogen Spray 20 16,232 4,637
30 10,821 4,058
Durations and 40 8,116 3,607
Pulse Counts for 50 6,492 3,246
60 5,410 2,951
Spot Sizes From 70 4,637 2,705
6 mm to 18 mm 80 4,058 2,497
90 3,607 2,318
100 3,246 2,164

Spray Duration Pulses Available Pulses Available

Table 3.10 (ms) (Post Spray = 0) (Post Spray = 50)
Cryogen Spray 10 45,754 7,625
15 30,502 7,039
Durations and 20 22,877 6,536
Pulse Counts for 25 18,301 6,100
30 15,251 5,719
the 1.5/3 mm 40 11,438 5,083
Delivery System 50 9,150 4,575
60 7,625 4,159
70 6,536 3,812
80 5,719 3,519
90 5,083 3,268
100 4,575 3,050

CAUTION!
FAILURE TO INSTALL THE APPROPRIATE SIZE CANISTER FOR YOUR LASER
OR FAILURE TO REPLACE IT AS INSTRUCTED CAN LEAD TO ADVERSE
CLINICAL OUTCOMES INCLUDING BURNS.
SUCH ADVERSE RESULTS MAY OCCUR AS A RESULT OF THE FOLLOWING:
 SIGNIFICANTLY REDUCED COOLING OF THE EPIDERMIS FOR A
GIVEN LASER ENERGY
 INADEQUATE PRESSURE TO FILL A TREATMENT AREA
 DO NOT ATTEMPT TO USE THE CANISTER BEYOND THE FIRST
OCCURRENCE OF THE “REPLACE CANISTER” MESSAGE.
 DO NOT RESET SYSTEM PULSE COUNTERS WITHOUT REPLACING
THE CANISTER.
 DO NOT INSTALL PARTIALLY USED CANISTERS.
 YOUR SYSTEM HAS BEEN CONFIGURED FOR A SPECIFIC SIZE
GENTLECOOLTM CANISTER. ONLY INSTALL THE APPROPRIATE SIZE
CANISTER AS INDICATED BELOW:
Canister Size Candela P/N Laser Type

1000 gram 1600-00-0210 GentleYAG

There are two pulse counters: Treatment Pulse Counter (shown on the “next” screen)
SYSTEM COUNTERS and Total Pulse Counter (shown on the “Laser Variable” Mode Screen). Both
counters keep track of delivered pulses but only the Treatment Pulse Counter can be
reset. The Total Pulse Counter is used to keep track of the total number of laser
pulses delivered by the laser system. The Treatment Pulse Counter is used to keep
track of the number of pulses used in a treatment session. Both pulse counts exclude
pulses used during calibration.
The Treatment Pulse Count is reset to zero by pressing the PULSE COUNT button
Pulse Count/ for approximately 3 seconds. The system acknowledges the selection by responding
Reset with a short beep tone and by setting the lower count value displayed within the
PULSE COUNT button to zero. The Total Pulse Counter (shown on the “Laser
Variable” Mode Screen) can not be reset to zero.
The calibration procedure is initiated by pressing the CALIBRATE button. Note that
Calibrate Button the system will initiate the calibration procedure automatically if READY state is
entered, a calibration is required, and the trigger switch is depressed. The handpiece
must be fully inserted into the cal port during the calibration routine.
After calibration, the system is in READY state and the trigger switch is enabled. The
operator can switch between READY state and STANDBY state as needed without
recalibrating provided that the fluence parameters have not been changed and no
more than thirty minutes has elapsed since the last calibration.
Language Select The language select button displays messages in the selected language. Press the
down or up arrow to select the desired language.
Spotsize This dual purpose button displays the current delivery system spotsize, and when
depressed delivers a cryogen PURGE pulse. The purge button is used to remove air
Identification from the handpiece assembly when a new canister or delivery system is installed. The
system will prompt the user when a purge is necessary. This action must be done
& Purge Button with the handpiece removed from the calibration port and pointed in a safe direction.
This button located on the second screen allows the user to select from six aiming
Aiming Beam beam intensities. The green aiming beam, which is visible only in the READY state,
Button serves as a treatment area target as well as an emissions warning device. The aiming
beam cannot be turned OFF.
This button is used to select the repetition rate on the main screen.
Repetition Rate This button is used to access available screens. There are two operating screens and
one auxiliary screen(Laser Variable Mode- LVM) See Figures 3.1-3.3 for
Next Screen Button descriptions.
Laser emission is generated by depressing the trigger switch, provided the system is
OTHER in the READY state & calibrated.
When the trigger switch is pressed, DCD spray (if DCD Pre or Post Spray is on) and
CONTROLS laser pulses are delivered at the distal end of the handpiece.
The fingerswitch or footswitch can be selected with this button. Depress this button
Triggerswitch: and use the “UP” or “DOWN” arrows to choose the triggerswitch type. For safety
Fingerswitch reasons only one type of triggerswitch can be active at one time. For example, if the
Footswitch footswitch is selected the fingerswitch will be disabled.

The calibration port (Cal Port) is used to measure the laser output energy. The
Calibration Port handpiece must be inserted into the calibration port in order to initiate this procedure.
The distance gauge must be removed, and the handpiece cleaned and dried before the
handpiece is placed in the calibration port.
The remote interlock connector, located on the upper rear panel, may be connected to
Remote Interlock one or more switches on the laser room door(s). When the interlock is connected, the
laser system shuts down if the laser room door(s) is opened. The switch must be
connected so that with the door closed, the switch contacts are closed. When the
door is open, the switch contacts must open. When remote interlock is not in use, the
supplied jumper must be plugged into the interlock connector. The circuit requires a
switch with a minimum rating of 24 VDC at 250 mA (1/4 Amp).
Footswitch Connector The footswitch connector is located on the rear panel of the laser system. The
footswitch connector is a rigid tube with a smooth taper. To install the footswitch,
push the pneumatic footswitch hose over the connector (tube). Pull to remove. The
length of the footswitch tubing can be shortened, if desired, using scissors.
The on/off main switch is located on the rear panel of the laser system and must be in
On/Off Mains Switch the „1‟ (on) position for the laser system to operate. Always place the on/off main
switch in the „0‟ (off) position when the laser is not in use.

Section 4
System Start-Up

1. Cover treatment room windows with an opaque material to prevent unintended

LASER SYSTEM viewing.
START-UP 2. Post laser warning signs at each entrance of the treatment room.
3. Ensure an adequate number of protective eyewear is available. Proper eyewear
will filter light at a wavelength of 1064 nm with an O.D. of 6.3 or greater.
4. Plug the laser into the correct electrical outlet. Ensure that the main circuit
breaker on the upper rear panel is in the “ON” position.
5. Select and install the desired delivery system. Insure that the fiber connector at
the laser is secure.
6. Set up the delivery system on the fiber pole as per section 1 of this manual.
7. Inspect and verify that the handpiece window is clean.
8. The keylock switch has three positions: “ ” (off), “ ” (on), and “ ”

(start). The switch returns to the “ ‟‟ position once the laser system starts and a
“power on” audible beep will sound. To start the laser system, turn the
keyswitch fully clockwise from the to the start position, and then
release. Once released the keyswitch will return to the on “ ” position similar
to an automobile ignition switch . There may be a delay of several seconds
before the system initializes. This is normal. The system will now enter the
warm-up state (approx. 25 min). After the warm-up is complete, the system will
enter the STANDBY state.

9. After warm-up is completed, a warning will appear on the touchscreen to

remind the user to perform user verification tests. The warning will read “
“Perform Delivery System Test.”
10. Perform User Verification Tests as outlined in Section 6 of this document.

Important !
The delivery system should be checked at the beginning of each treatment day
for proper operation. In addition, check the delivery system if there is an
unexplained treatment response noted or the delivery system has been dropped.
11 After tests are completed, depress the Check Box on the screen displaying the
“Perform Delivery System Test.” message.
12. Select the desired laser system operating parameters as follows:

a. Select Fluence
b. Select Pulsewidth
c Select Repetition Rate
d. If system has the DCD option, set DCD for desired spray duration and
delay parameters
NOTE: If you experience difficulty setting the operating parameters, check
Tables 3.1 to 3.8 and ensure the settings are allowed for the selected spot
size.
e. Fully insert the handpiece into the CAL port.
f. Press the CAL switch and follow the instructions on the display
panel.
Note: Repetition rate may be adjusted before or after calibration

Note: Before calibration a message will appear on the touchscreen
for the user to “Confirm Treatment Parameters”. After confirming,
the “check box” must be pressed prior to proceeding with the
calibration.
g. Remove calibrated handpiece when CAL is complete.
Note: After calibration the laser will return to STANDBY mode for
safety reasons. This is to allow the user to install distance gauge.
13. Install distance gauge and press the READY button. Aim the handpiece at a
white piece of paper and inspect the aiming laser for circular uniformity and
clarity.
Note: If the aiming laser spot is not uniform, check for distance gauge
interference. Replace bent distance gauge if necessary. If using the 1.5 mm
distance gauge, ensure that the aiming beam is at or near the middle of the
distance gauge ring. If not, remove and install the distance gauge again to
correct the problem. The distance gauge must be replaced if correct results
can not be achieved.
Important !
Do not operate laser if aiming beam is not present! This may be an
indication of a broken fiber optic. If the aiming laser is not present, replace
the delivery system. If this does not correct the problem, call for Service.

14 Perform laser treatment.

Note: In some cases, when treating large areas, a PURGE fault may appear as
a result of the accumulation of reflected heat. If this happens, allow delivery
system to cool before continuing treatment. Place laser in STANDBY state
and check the windows on the distance gauge and handpiece slider. Dirty
windows will reflect laser energy back into the handpiece which will heat it
up and cause PURGE faults. If possible, replace with a cool delivery system.
16. Place the laser into STANDBY after use. Document laser use.
CAUTION!
Failure to initiate a calibration after cleaning/replacing the window or delivery
system may result in the delivery of excessive laser energy.

NOTES
 To return the pulse counter to zero, press the PULSE COUNT button for
3 seconds.
 A calibration will automatically be required when:
1) Laser is turned on;
2) FLUENCE parameter or pulsewidth parameter changed;
3) Delivery system changed;
4) Slider plunger depressed;
5) Slider position changed;
6) Specific faults occur;
7) In STANDBY for more than 30 minutes;
 The user must remember to initiate a calibration after:
1) Cleaning or replacing a window in the handpiece Slider.
2) Replacing the delivery system.
3) Changing the treatment spot size

Section 5
Calibration
Procedure

CAUTION!
FAILURE TO PERFORM CALIBRATION AFTER A HANDPIECE
SLIDER WINDOW HAS BEEN CLEANED OR REPLACED, CAN
RESULT IN DELIVERY OF FLUENCES GREATER THAN
SPECIFIED ON THE CONTROL PANEL.
The GentleYAG Laser System requires that the laser be calibrated prior to each
CALIBRATE patient treatment. During calibration, the handpiece without the Distance Gauge is
inserted into the Cal Port allowing an internal energy meter to measure the laser
PROCEDURE output energy delivered at the handpiece. The system adjusts itself until the desired
output is obtained. Usually 3 - 15 laser pulses are required before calibration is
complete.
 Inspect and verify that the handpiece Slider window is clean.
 Select the desired Delivery System. Make sure the Delivery System is
properly connected and secured.
 Put on laser safety eyewear.
 Select the desired Fluence parameter values via the Display Panel.
 Remove the Distance Gauge from the handpiece.

 Fully insert the handpiece into the Cal Port.

 Press the CALIBRATE button on the Display Panel and follow the
instructions provided in the calibration message window.
 Remove handpiece from the Calport when instructed to do so and install
distance
Pressing “X” allows the operator to return to the Main screen in Standby. The
operator can then adjust the laser output parameters as needed before restarting the
calibration procedure.
After successful completion of the calibration procedure, remove the Delivery

System from the Calport, install the Distance Gauge and begin treatments.
During calibration the software performs a delivery system transmission check. If

the delivery system transmission is low, the software will display a message to clean
the HP Slider window. The user can stop the calibration by pressing “YES” and
clean the HP Slider window (see Section 6 for window cleaning procedure) or press
“NO” to continue the calibration. The performance of the delivery system is
improved by using a clean or new HP Slider window. Clean optics will increase the
life of the delivery system.

NOTE
If the desired fluence cannot be reached, a FAULT will be displayed. If this
occurs, decrease the fluence and perform another calibration. When this
happens, the laser system is degraded and does not have sufficient energy to
calibrate properly. A dirty window on the handpiece slider may be the cause of
the problem. Clean or change the window using the instructions in Section 6
(Maintenance and Troubleshooting section). If the problem cannot be corrected,
the system may require service. Call Candela Service for more information.
If a higher fluence is desired immediately, change the delivery system to one

with a smaller spot size.

Section 6
Maintenance/
Troubleshooting
&
Delivery System User
Verification Tests

CAUTION!
WHILE SERVICING THE GENTLEYAG LASER SYSTEM CAN BE
EXTREMELY DANGEROUS IF PROPER SAFETY PRECAUTIONS
ARE NOT TAKEN.
THE GENTLEYAG LASER SYSTEM SHOULD BE SERVICED ONLY

BY QUALIFIED TECHNICIANS WHO HAVE RECEIVED
APPROPRIATE TRAINING FROM CANDELA. ANY ATTEMPT BY
AN UNAUTHORIZED PERSON TO PERFORM ANY SERVICE
PROCEDURE MAY RESULT IN PERSONAL INJURY AND WILL
VOID ANY WARRANTY ON THE LASER SYSTEM.
The GentleYAG laser delivery system utilizes fiber optics that can be damaged if
FIBER-OPTIC subjected to excessive bending. To avoid damage to the optical fiber, limit bends to a
radius of 6 inches (15 cm) or greater.
DELIVERY
The delivery system should be checked before each procedure by observing aiming
SYSTEM beam quality. The beam as viewed against a white sheet of paper should have
intensity, homogeneous distribution and a well defined circumference. If the aiming
beam is non-existent, discontinue use immediately as the fiber may be broken. A dim
aiming beam may also indicate a broken fiber or dirty or damaged windows. Clean

or replace the distance gauge and slider windows before repeating this test. Use of a
damaged fiber-optic delivery system is dangerous and must be avoided. If damage is
suspected discontinue use immediately.
Always cap the proximal connector of the fiber with the attached rubber cap
whenever the fiber is not installed on the laser.
WINDOWS Windows have been designed into distance gauges (with the exception of the 3mm
distance gauge) and slider to protect the delivery system optics. Due to the nature of
some procedures, the windows will require frequent cleaning and/or replacement to
maintain proper system performance. Windows should be maintained in accordance
with Candela procedure 8502-00-0847. Assembly pictures and procedures specific to
the GentleYAG delivery systems are included in this section.
Washer
Window O-ring

Note: Special instructions for the 18mm distance gauge, the 18mm distance gauge
contains a metal washer next to the window. Please note the proper order of
assembly when cleaning or replacing the window (shown above).
Caution: The cooling water is heated to 65˚C. Do not stick fingers into tank. Avoid
WATER COOLING splashing of heated water
SYSTEM The system is cooled with distilled water. The water level should be checked
monthly if the system is used daily, and every 6-months if used weekly. The water
tank is located within the box protruding from the rear of the laser. Turn the filler
cap counter-clockwise to remove. Inspect level by looking into tank. Fill with
distilled water if the level is below the base of the filler neck or if a system message
indicates a fault code preceded by a “7”.
The exterior of the laser system should be cleaned weekly with a soft cloth slightly
CLEANING AND moistened with a solution of mild soap and water. Do not use harsh detergents. To
disinfect the exterior of the laser system, use a soft cloth moistened with an alcohol
DISINFECTING solution. Ethyl or isopropyl alcohol with strength of 70% - 90% makes a good
general purpose disinfectant.
E To clean and disinfect the Delivery System handpiece:)

Handpiece Immediately after each treatment session, wipe the exterior surface of the handpiece
body with a gauze pad moistened with an alcohol solution (see last paragraph). Take
care to avoid contaminating the internal optical surfaces of the handpiece. When
cleaning the handpiece with an alcohol solution, dry the area thoroughly prior to
beginning a laser procedure.

The distance gauge is the only part of the handpiece to contact the patient. Proper
Distance Gauge care of the handpiece distance gauge will result in improved laser performance.
To Clean/Disinfect the Distance Gauge Assembly: Clean by wiping with gauze pad
moistened with an alcohol solution and allow to dry.
Note: Special instructions for the 18 mm distance gauge
The 18 mm distance gauge contains a metal washer next to the window. Please note
the proper assembly when cleaning or replacing the window
Note: Special instructions for the 1.5mm distance gauge
The 1.5 mm distance gauge contains a lens and a window. Please note the proper
assembly when cleaning or replacing the window

CAUTION!
Distance Gauge and
ONLY USE GENTLEYAG REPLACEMENT WINDOWS IN HANDPIECE
HP Slider Window AND SLIDER OR PERMANENT DAMAGE WILL OCCUR.
THE DISTANCE GAUGE ON THE END OF THE HANDPIECE MAY

BECOME SOILED WITH NORMAL USAGE. TO ENSURE PROPER
FLUENCE DELIVERY, IT IS IMPORTANT TO INSPECT AND
CLEAN THE DISTANCE GAUGE WINDOW FREQUENTLY SO
DEBRIS IS NOT BURNED INTO THE WINDOW SURFACE.
ALWAYS PUT THE LASER SYSTEM INTO “STANDBY” OR “OFF”

WHEN CHANGING A DELIVERY SYSTEM OR DISTANCE GAUGE
WINDOW OR WHEN A HANDPIECE SLIDER WINDOW IS
CLEANED OR REPLACED.
WHEN THE HANDPIECE SLIDER WINDOW OR THE DISTANCE

GAUGE WINDOW BECOMES DIRTY OR BURNT, THE AMOUNT
OF ENERGY DELIVERED TO THE PATIENT MAY BE REDUCED.

AFTER REPLACING A DIRTY OR BURNT WINDOW THE LASER

SYSTEM MUST BE RECALIBRATED.
AFTER REPLACING/CLEANING A DIRTY WINDOW, (OR

CLEANING A DIRTY LENS ON THE 1.5 MM DISTANCE GAUGE)
YOU MAY NEED TO REDUCE THE FLUENCE TO OBTAIN PRIOR
RESPONSE.
Figure 6.1
Distance Gauge
(8 mm to 18 mm)

For 8 mm to 18mm Amber Distance Gauges

To clean or replace the Distance Gauge window: (figure 6.1)
1. Wear dustless gloves to prevent smudges or fingerprints on lens.
2. Put the laser in STANDBY and remove the distance gauge assembly from the handpiece.
3. The Distance Gauge window is held in a groove in the rear (non treatment) end of the
assembly with an O-ring. A notched access in the groove allows easy removal of the O-
ring and window.
4. With the treatment end of the distance gauge pointing downwards, remove the O-ring with
tweezers, or poke a pointed object into the notch. Gently pull the O-ring toward the center
of the window to free the O-ring from the groove.
5. Turn the assembly upside down, allowing the window to fall out onto a clean surface. (If
needed, gently tap the side of the Distance Gauge with your finger).
6. (Used windows only)
a. Clean the windows in an alcohol solution. Rinse thoroughly with clean water, and dry
with a lint free tissue.
b. Re-inspect the window and if unacceptable, discard window and replace with a new
one.
7. Grasp the new or cleaned window by the edges and place it back into the Distance Gauge
assembly so it is resting flat on the ledge.
8. Reinsert the O-ring into the groove. Use the tip of the tweezers or a pointed object to
gently push the O-ring fully into the groove, being careful not to touch the window.
9. Perform a Calibration Procedure per section 5. Then slide the Distance Gauge back into
the HP.

Figure 6.2
Distance Gauge
(1.5 mm) Lens
For 1.5 mm Black Distance Gauges

To clean or replace the Distance Gauge window: (figure 6.2)
2. Put the laser in STANDBY and remove the distance gauge assembly from the
handpiece.

3. The Distance Gauge window is held in a groove in the front (treatment) end of
the assembly with an O-ring. A notched access in the groove allows easy
removal of the O-ring and window. Note that the non-treatment end of the
distance gauge contains a lens. This lens is not removable by the customer. If the
lens becomes dirty, use the cleaning process at the end of this procedure.
4. With the treatment end of the distance gauge pointing upwards, remove the O-
ring with tweezers, or poke a pointed object into the notch. Gently pull the O-
ring toward the center of the window to free the O-ring from the groove.
5. Turn the assembly upside down, allowing the window to fall out onto a clean
surface. (If needed, gently tap the side of the Distance Gauge with your finger).
a. Clean the windows in an alcohol solution. Rinse thoroughly with clean water,
and dry with a lint free tissue.
b. Re-inspect the window and if unacceptable, discard window and replace with
a new one.
7. Grasp the new or cleaned window by the edges and place it back into the
Distance Gauge assembly so it is resting flat on the ledge.
8. Reinsert the O-ring into the groove. Use the tip of the tweezers or a pointed
object to gently push the O-ring fully into the groove, being careful not to touch
the window.
9. Perform a Calibration Procedure per section 5. Then slide the distance gauge
back into the HP.

To clean the 1.5 mm Distance Gauge lens: (figure 6.2)

2. Put the laser in STANDBY and remove the distance gauge assembly from
the handpiece.
3. The Distance Gauge lens is on the non-treatment end of the distance gauge.
The lens can not be removed by the customer but it can be cleaned while it
is in the distance gauge.
4. Wipe the lens ONCE with a tissue dampened with alcohol and then discard
the tissue.
5. Use a second tissue that is dry and wipe the lens ONCE to clean off the
alcohol. Discard the tissue
6. Repeat steps 4 and 5 (wiping only once with each tissue) until the dirt on
the lens is removed or no improvement is seen.
7. In most cases, only the side of the lens that is exposed on the non-treatment
end of the distance gauge will become dirty. The side of the lens that is on
the treatment end of the distance gauge should remain clean since it is
protected by the window in the distance gauge. However, if this side of the
lens becomes dirty, remove the distance gauge window and then perform
steps 4 and 5 until the lens is clean.
8. Perform a Calibration Procedure per section 5. Then slide the distance
gauge back into the HP.

To clean or replace the HP Slider window: (figure 6.3)

2. Turn the laser OFF. Remove the Distance Gauge. Slide the HP Slider through
the front of the HP; exposing the slider window or remove the HP Slider entirely
from the rear of the HP assembly. The window is held in a groove in the front
end of the Handpiece Slider with an O-ring. A notched access in the groove
allows easy removal of the O-ring and window.
3. With handpiece pointing upward, remove o-ring with tweezers, or poke a
pointed object into the notch. Gently pull the O-ring toward the center of the
window to free the O-ring from the groove. Then turn the handpiece slider
upside down, allowing the window to fall out onto a clean surface. (If needed,
gently tap the side of the handpiece slider with your finger).
c. Clean the windows in an alcohol solution. Rinse thoroughly with clean
water, and dry with a lint free tissue.
d. Re-inspect the window and if unacceptable, discard window and replace
with a new one.
5. Grasp the new or cleaned window by the edges and place it back into the
handpiece slider so it is resting flat on the ledge.
6. Reinsert the O-ring into the groove. Use the tip of the tweezers or a pointed
object to gently push the O-ring fully into the groove, being careful not to touch
the window.
7. Slide the HP Slider back into the HP. Select a spot size. Then perform a
Calibration Procedure per section 5.
Figure 6.3
Handpiece
Slider
Close-up O-ring Window Groove HP Slider

The handpiece delivery system should be replaced with the system turned off. Refer
HANDPIECE to figures 6.4 and 6.5 for installation and removal of the handpiece delivery system.
When not in use, the delivery systems should be stored in the supplied plastic case
DELIVERY with the plastic caps over the ends of the fiber.
SYSTEM Removing the Delivery System:
REPLACEMENT
1. Remove the Valve Control by grasping the connector near the red dot and
pulling straight back.
2. Remove the Cryogen Line, using two hands, by pushing the knurled Cryogen
Line Receptacle toward the laser and pulling the Cryogen Line Connector away
from the laser.
3. Remove the Fiber-optic by gently pulling the connector straight out of the
receptacle.
4. Place delivery system into supplied storage case with plastic end caps on the
fiber for protection.
Connecting the Handpiece Delivery System:
1. To install the Fiber-optic:

a. Carefully insert the Fiber-optic Connector into the Fiber-optic Receptacle
until it clicks in or stops.

CAUTION!
IF THE FIBER IS NOT SEATED PROPERLY, DAMAGE TO THE FIBER
COULD OCCUR.
2. Connect the Cryogen Line, using two hands, by pushing the knurled Cryogen
Line Receptacle and the Cryogen Line Connector toward the laser until it stops.
Release the knurled connector. The male and female ends of the connectors fit
together.
3. Connect the Valve Control by aligning the RED DOT on the Valve Control
Receptacle with the RED DOT on the Valve Control Connector and pushing in
the connector until it stops.

Handpiece
Laser
Aperture
Figure 6.4
Handpiece
Delivery System
RED DOT
Close-up
Valve Control
Connector
Cryogen
Line
Connector
Fiberoptic
Connector

Figure 6.5
Control Panel
Cryogen
Close-up Line
Receptacle
Valve
Control Fiberoptic
Receptacle Receptacle

CAUTION!
CRYOGEN THE CONTENTS OF THE CRYOGEN CANISTER ARE UNDER
PRESSURE. READ THE MATERIAL SAFETY DATA SHEET
CANISTER (MSDS) AND THE LABEL ON THE CANISTER BEFORE
HANDLING.
Follow the instructions shipped with each replacement canister.

REPLACEMENT
Additionally, once the canister is installed, the canister count must be reset. If the
newly installed canister is at room temperature or cooler, a 20 - 25 minute WARM-
UP period will be needed prior to use. The WARM-UP screen will appear once the
laser is switched to the READY state if additional warming is required.
CANISTER A canister warmer is available and may be used to hold canisters and minimize the
warm–up period.
WARMER
If a major cryogen leak occurs, disconnect the delivery system from the laser or
MAJOR remove the canister from the laser. Ventilate the room thoroughly and call Service to
CRYOGEN correct the problem.
LEAK For additional information, refer to the MSDS sheets supplied with each cryogen
canister.
Disposal of the canister can be achieved by contacting a waste disposal company.

DISPOSAL Alternatively, the canister may be emptied following the instructions that come with
each canister and disposing in the trash.
Overview of Tests:
This section contains information regarding three tests. Each test should be
USER performed for the indicated hand pieces at the beginning of each treatment
VERIFICATION day. In addition, check the delivery system if there is any concern about the
delivery system‟s performance or the delivery system has been dropped.
TESTS Discontinue use of the delivery system if problems are noted in any of these
tests or you suspect / observe other factors that may affect performance.
You will need the following supplies to perform these tests:
 Laser Safety Glasses

 Cryogen Coverage Template 1301-00-8291 included in the accessory kit
supplied with the laser.
 VPYAG distance gauge.

The following tests are described in this section
1. Cryogen Alignment: Verifies the cryogen spray nozzle is properly aligned

with the distance gauge ring.
2. Cryogen Coverage: Verifies the spray duration required to fill the distance
gauge ring.
3. Cryogen Air Bubble Detector: Verifies that air bubbles in the cryogen line
are detected and the associated “fault” message is displayed on the system.
Test #1 Cryogen Alignment

Purpose:
To verify the cryogen spray nozzle is properly aligned with the distance
gauge ring. This procedure is for all delivery systems.
Procedure:
1. Put the laser in “standby”. Caution- laser should remain in

“Standby” mode for duration of test
2. Select “DCD –on”.
3. Install GentleYAG 12mm distance gauge PN 7122-00-3109.
The 1.5/3 mm handpiece must be set at the 3 mm spot size.
4. Select 30ms of DCD Spray.

5. Point hand piece away from objects and personnel (toward the
floor). View the contact ring of distance gauge, looking from
the hand piece.
6. Press purge button.
DCD Spray should flow completely through the contact ring. There
may be a minimal spray mist seen hitting the contact ring. No spray
should be spraying beyond outside of the contact ring.
Acceptable No mist on contact ring
No Cryo
clipping on 12
mm distance
gauge

Acceptable
Small amount of mist on contact
Small Cryo
clipping on 12
mm distance
gauge
Unacceptable results
Excess mist on contact ring
Cryo clipping on
12 mm distance
gauge

Results
Acceptable alignment- no further action needed
Unacceptable alignment, repeat the test with a different distance
gauge.
Repeat test results
If the test shows acceptable alignment with the new distance gauge,
discard the original distance gauge.
If the result is still “unacceptable”, replace hand piece or contact
Candela Technical Support.

Test #2 - Cryogen Coverage:

Purpose:
To verify the proper spray duration required to fill the distance gauge ring.
(Note: the distance gauge ring is larger than the spot size marking). Table 6-
1 shows the available distance gauges for the GentleYAG laser system.
GentleYAG Distance Gauge Part Number

1.5mm 7122-00-3556 (small)\
7122-00-3561 (large)
Table 6-1 7122-00-3535 (small)
3mm
Available Distance 7122-00-3534 (large)
Gauges 8mm 7122-00-3502
10mm 7122-00-3503
12mm 7122-00-3109
15mm 7122-00-3504
18mm 7122-00-3505
Note: The part numbers shown for the 8 mm to 18 mm
distance gauges are for packages of 5 distance gauges.

Note: The below tests and values are not intended to represent treatment
parameters, but rather provide a check on proper functionality of the
handpiece and provide a reference for the user to help identify changes in the
handpiece operation.
If you use multiple delivery systems, these checks should be made utilizing
the smallest and largest distance gauge for each delivery system.
Procedure:
1. Put on appropriate laser safety glasses
2. Put the laser in “Standby” Caution- laser should remain in “Standby”
mode for duration of test.
3. Select “DCD –on”.
4. Install appropriate distance gauge from Table 6.2 below.
5. Select “Spray Duration” shown in Table 6-2.
6. Place hand piece distance gauge over desired distance gauge spots on
the template (1301-00-8291). For 6 mm to 18 mm spot sizes, use the 8
mm to 18 mm spots on the template in the area listed for GL/GYAG
Family Spot Sizes. For the 1.5 mm and 3mm spot sizes, use the
distance gauges with the small treatment ring. Place the distance
gauge over the 5 mm spot on the template in the area listed as Vbeam
Spot Sizes.
7. Press purge button.
8. Remove hand piece QUICKLY from template.
9. The DCD Spray should completely fill the inner spot.
NOTE: Spray outside of the spot is acceptable as long as the inner spot
is completely filled. (This spray may be from reflected spray off the
paper). If the spot does not fill or a leak is noted, the handpiece
assembly should be replaced or contact Candela Technical Support.
Distance Gauge Spray Duration

Spot Size Setting
Table 6-2 1.5 mm (small) 30 ms
Spray Settings 3 mm (small) 30 ms
for Fill Test 8 mm 30 ms
10 mm 30 ms
12 mm 40 ms
15 mm 50 ms
18 mm 60 ms
Note: Use the 8 mm distance gauge and 8 mm spot on the

template when testing the 6 mm spot size.

Test #3 Cryogen Air Bubble Detection

Purpose:
To ensure that that air bubbles in the cryogen line are detected and the
associated “fault” message is displayed on the system.
Important: This procedure must be done with each GentleYAG

handpiece delivery system in your possession. The subsystem being
tested is inside of each delivery system, not in the laser system.
Procedure
1 Insure that the installed DCD canister is not empty.

Warning: Put on appropriate laser safety glasses
2. Turn on the system and allow the “WARM UP” to
complete.
3. With the Electrical Connector installed, disconnect the
Cryogen Connector (see Figure 3).

Electrical Connector
Cryogen Connector
Figure 3 - Delivery System Connections
4. Set the DCD spray on the front panel to the highest setting.
5. Set the FLUENCE to the lowest setting (this varies by spot size).
6. Enter the “Ready” mode, and calibrate the laser by pressing on the
footswitch.
7. Remove the handpiece from the CALPORT and aim in direction
away from personnel (such as the floor).

8. Depress the footswitch to pulse laser continuously until a “PURGE

REQUIRED” window box appears on the user screen and lasing
ceases. This should happen in less than 50 pulses.
Results Comments Action
If you get This particular You may continue use of this

“PURGE handpiece passed handpiece
REQUIRED” the test
If “PURGE This particular Discontinue use of this

REQUIRED” handpiece failed handpiece and call Candela
does not occur the test Tech Support at (508) –358-
7637 ex 336 or (800) –733-
8550 ex 336
9. Reconnect the Cryogen Connector (see Figure 3) and press reset to

use the system, or repeat the test on other GentleYAG handpiece
delivery systems.
10. Depress “purge” may be required until the line is refilled.

The GentleYAG Laser System incorporates a routine to calibrate the touchscreen of

the laser. This touchscreen calibration should only be performed when the
touchscreen is not responding correctly.
TOUCHSCREEN The routine can be entered from the diagnostic menu of the laser by pressing the
CALIBRATION touchscreen calibration button.
PROCEDURE NOTE: To access the diagnostic menu:
Press and hold the next button for 3 seconds.
When the
touchscreen
calibration is
initiated the
screen is
cleared and the
following
appears:

1) Using a cotton swab or small blunt tipped instrument press the center of the
flashing box until it disappears.
2) A similar box will appear in the opposite corner of the screen. Repeat step 1.
3) Two smaller boxes will appear when steps 1&2 have been completed. Press
both of these buttons until they disappear.
4) “TOUCHSCREEN Calibration Successful” will appear if the calibration is

complete. If the calibration is unsuccessful, the system will return to step 1.
This process will repeat 2 times.
5) If the calibration is not successful, software will use default parameters that will
still allow use of your laser.

SITUATION PROBABLE
TROUBLE- / SYMPTOM CAUSE or
INDICATOR
SOLUTION
SHOOTING The system The power is not Reseat the power cable
cannot be connected and check circuit breaker.
turned on. properly.
The laser system Switch the circuit breaker
circuit breaker is to the "on" position.
in the "off"
position.
The keylock Turn the keylock switch
switch was not fully clockwise to the "
fully engaged. " position and release.
The external Check the remote
interlock is interlock connection. If
defeated. connected to a door, make
sure the door is closed.
Laser pulses, The DCD Pre and Select the DCD Pre or
no cryogen is Post spray Post spray and use the “up
delivered settings are set to arrow” to increase the
zero “O”. spray setting.

SITUATION
PROBABLE
TROUBLE- / SYMPTOM
CAUSE or SOLUTION
INDICATOR
SHOOTING
Cryogen leak. Tubing breaks in Remove the cryogen
the delivery canister or disconnect the
system. handpiece assembly from
the laser. Call Service.
Warm-up time The water Call Service.
has exceeded temperature
60 minutes. control circuitry
failed.
Ineffective System or Fiber Perform a calibration
fluence is degraded. procedure per Section 5.
response. Call Service if problem
persists.
Replace There is Replace the cryogen
Canister insufficient canister with a new
Message cryogen in the canister supplied by
Appears canister. Candela; Depress the
Canister Count switch for
3 seconds to reset the
canister count.

SITUATION PROBABLE
INDICATOR
SOLUTION
SHOOTING Purge Bubbles have Press the purge switch

Required been detected in until problem resolves.
the cryogen line. This must be done with
the handpiece outside of
the calibration port. If
problem persists, call
Service
Laser will not Triggerswitch is De-activate Triggerswitch
enter the depressed.
READY state
Aiming beam  Damaged or  Replace delivery
missing in the broken fiber system
READY state  Bad aiming  Otherwise call for
laser or service.
driver circuit

SITUATION PROBABLE
SOLUTION
INDICATOR
SHOOTING Aiming beam  Intensity set too  Set aiming beam
appears dim low intensity using
 Dirty distance button provided
gauge and/or on “NEXT”
slider windows screen
 Dirty or damaged  Clean or replace
slider optics windows
 Failing aiming Otherwise call for
laser service.
Aiming beam  Dirty distance  Clean or replace
appears non- gauge and/or windows
uniform slider windows  Replace delivery
 Dirty or damaged system
slider optics
 1.5 mm distance
gauge not
installed properly
on end of slider

A fault message typically occurs due to a system malfunction. Sometimes clearing

FAULT / WARNING the fault and retrying the previous operation can be successfully accomplished
without further faults occurring. If the fault message persists, call Candela Service
MESSAGES and report the Fault Number. Fault processing automatically places the system into
the Standby state. The following conditions are considered outside of „normal‟
system operation and will display a warning or fault message
.
FAULT # DESCRIPTION
1 – BUBBLE HP Bubble Circuit Test didn‟t detect a change in the signal
1.1
DETECT (with DCD-enabled HP).
CIRCUIT Canister Bubble Circuit Test didn‟t detect a change in the
FAULT 1.2
signal (with DCD-enabled HP).
2 – ROM Calculation of checksum at power-up does not match
CHECKSUM
2
checksum value in memory.
Shutter isn‟t in correct state when checked. Does not
3 – ROTARY 3.1
respond to actuation to correct state.
SOLENOID
FAULT Aperture isn‟t in correct state when checked. Does not
3.2
respond to actuation to correct state.
4.1 HVPS reported a fault (Watch dog time-out)
4 – HVPS FAULT
4.2 HVPS Communications Time-out

CAL completion HV sample to Ready entry HV smp not

within +-3% at End of Charge (EOC) OR
5.1
5 – HV HV Reference and HV sample not within +-5% at End of
TOLERANCE Charge
FAULT 5.2 No EOC signal present within 3 secs after HV setting
No EOC signal present after DCD pre-spray already
5.3
occurred.
Expected Head Energy (xHD) is calculated > Max CAL
6.2
6 – CALIBRATION HD Energy of 100 J.
FAULT 6.3 Laser failed to CAL to desired Fluence within 20 pulses.
6.4 CAL required a HV > 1200V for desired Fluence.
7.1 DI temp < 60degC when not in warm-up.
7.2 DI temp > 70degC while in Ready state.
DI pressure switch does not change when power turned on.
7 – DI WATER
SYSTEM
7.3 OR
FAULT DI pump is not ON or DI pressure switch not actuated.
DI temp < Thermistor Open Temperature (5) OR
7.4 DI temp > Thermistor Shorted Temp (98) while in Ready
state
DCD pressure < 105 psi while in READY & INT_DCD &
8.1
8 – DCD SYSTEM HP w/DCD & spray setting is non-zero.
FAULT 8.2 DCD Pressure > 135 psi & INT_DCD
8.3 DCD Valve Current was not detected while spraying

9.1 DI temperature < 62degC after 60 minute warm-up

9 – WARM-UP
TIMEOUT DCD pressure < 105psi after 60 minute warm-up (Only
9.2
when DCD enabled)
10.1 HP type changed or unrecognized while in Ready
10 – DELIVERY
SYSTEM 10.4 Fiber not detected while in Ready
FAULT Slider button pressed while in Ready State. Cannot change
10.5
spot-size while in Ready.
On last treatment pulse, the head energy (HD) was 14%
12.1
lower than expected head energy (xHD).
12 – ENERGY On last treatment pulse, the head energy (HD) was 14%
12.2
OUT OF higher than expected head energy (xHD).
RANGE The head energy (HD) of the last pulse > Max Treatment
FAULT 12.3
HD Energy of 105J.
The HD total energy is not evenly balanced between each
12.4
subpulse (+-20%)
13 – TRIGGER
The redundant trigger switches were in two different states
SWITCH 13
FAULT for > 1 second while in ready.
14 – SIMMER
FAULT
14 The simmer did not start or dropped out while in ready.

Transmission (Tx) is < 70% w/HD or CP energy >1.5J

15.1
15 TRANSMISSION (Aper < 30% w/HD>6J or CP energy>2.5)
FAULT Transmission (Tx) is > 100% w/HD or CP energy >1.5J
15.2
(Aper >50% w/HD>6J or CP energy>2.5)
18.1 HD CktCal Test Energy incorrect or chksum corrupt.
18 CIRCUIT CAL
FAULT
18.2 DI Factor chksum corrupt
18.3 DCD Factor chksum corrupt
19.1 IGBT Trigger Fault
19.2 7875uf capacitor charge status incorrect
19– MODULATOR
FAULT 19.3 Lasing Timer Fault
19.4 Lasing Power Fault
19.5 HV Dump Fault

Replace Can Canister pulse count Replace DCD canister & reset
Warning (Only with reaches zero “0”, or when canister counter when ever this
DCD Option) air detected at the canister. message appears.
Messages Purge Air was detected in the With handpiece removed from
(Only with cryogen lines. Bubble the calibration port, depress the
DCD Option) percentage is outside of purge button until the message
tolerable range (~15% clears.
bubbles)
Exit to Clean Delivery System Examine HP Slider window. If
Window Transmission is low. necessary, clean or replace
Transmission is < 75% - window.
Delivery system degrading
-
Candela will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions, or other necessary information which will assist
the customer‟s appropriately qualified technical personnel to repair those parts of
equipment which are designated by Candela as repairable.

Section 7
Labeling
Symbols

The GentleYAG Laser Systems have been labeled in accordance with domestic and
LABELS international agency standards. All laser operators should be familiar with the
location and meaning of the labels.
The symbol on the rear panel of the laser is placed there to draw the attention
215 7-40 -7 000 R E V [ ]
of the operator to the manual for further information concerning the on/off mains
switch. The mains switch should be placed in the “0” position when the system is not
being used. When the system is to be used, the mains switch must be moved to the
“1” position.
See the following figures for label locations:
Label 1 Indicates to the user that precautions for handling “Electrostatic Sensitive”
device are applicable for the nearby delivery system connector. This label
is required by agencies to indicate static sensitive connections, where
electrostatic discharge could potentially damage components of a labeled
connection. The user should take anti-static precautions prior to accessing
this connection. Such precautions include simply discharging one‟s body to
a known grounded point prior to making a connection to the delivery
system connector. A good grounding point is the fiber receptacle. The
label is located near the delivery system connections.
Label 2 Multi-combined label. Label is located near the delivery system
connections.

A. The “Man” indicates that the delivery system is equipped with a “Type B”
applied part.
B. Indicates the emission of laser energy from this device.
C. Indicates this is the laser aperture.
Label 3 The Emergency Laser Stop Red Push Button will turn off the laser quickly.
Located on front display bezel.
Label 4 This label indicates that the protective panel encloses Class 4 laser
radiation. Label located on rear side of top cover.
Label 5 Multi-combined label. Label is located on rear panel above AC input
receptacle.
A. Indicates that accompanying documents contain electrical connection
information. That information will be found in the Electrical Requirements
section of this manual. Label is located on rear panel above AC input
receptacle.
B. Indicates Footswitch control hose connection.
C. Indicates the location of the remote interlock circuit that can be connected
to a door switch to shutdown the laser should a person enter the room
during laser emission. The symbol illustrates that an OPEN connection at
this point will inhibit the lasing function.

Label 6 Risk of electrical shock if serviced by unauthorized persons. There are

lethal voltages inside the system enclosure. Label is located on rear panel.
Label 7 Indicates a hot surface when unit is powered. The hot surface warning
applies strictly to the water in the water reservoir; which is only accessible
when the water reservoir cap is removed. Label is located on top surface of
the reservoir cover.
Label 8 Indicates that the reservoir is filled with water. The reservoir should be
kept full to the base of the filler neck with distilled water. The label is
located on top surface of the reservoir cover.
Label 9 Laser Identification label. This label is marked with the VA rating for the
system, as well as the model number, serial number and date and place of
manufacture. This label is located on the rear panel.
Label 10 Multi-combined label. Located on lower rear panel.
A. Indicates laser emission characteristics and classification per the IEC/EN
standards.
B. Indicates that this device emits laser energy.
C. CE mark with registration number of Candela‟s ISO Registrar. When
present, this marking indicates compliance with the European Medical
Device Directive. Refer to the Declaration contained inside the accessory
kit for details of compliance.

D. Indicates compliance with a branch of the US FDA which regulates laser

equipment. The GentleYAG Laser System has one labeling deviation
pursuant to Laser Notice No. 50, dated July 26, 2001, where the “Danger”
label required by 21 CFR 1040.10 (g) was replaced with a label bearing the
same technical content defined under IEC/EN 60825-1.
E. Indicates U.S. patents that may be covered on this laser system.
Label 11 If present, indicates that the laser is approved to UL or ETL standards.
Label 12 Indicates that the laser can be a mechanical tilt hazard; if the laser were not
kept upright.
Label 13 (DCD option only) Indicates a hot surface when unit is powered. The hot
surface warning applies strictly to the heater band, which is only accessible
when the cryogen tank is removed. Accidental contact with the heater band
will not cause a burn, but may cause an involuntary knee-jerk reaction
resulting in an injury. Label is located on top cover near DCD opening.
Label 14 International symbol indicating that laser light will be exiting from the
distal end of this cable. This label is wrapped around fiberoptic cable near
system connections.
Label 15 Handpiece delivery system identification information. Wrapped around
electrical cable near system connections.
Label 16 Safety ground symbol. This symbol located on the power cord entry box
tab indicates the location of the primary system safety ground. The screw
adjacent to this symbol should never be tampered with or removed.
Label 17 The Waste Electrical and Electronic Equipment (WEEE) Directive label on
the rear of the Laser System indicates that the Laser System and its
components can not be disposed of as regular trash. Contact Candela
Corporation for disposal instructions.

Label Locations
Label 2 Label 1
Label 3 A,B,C

Label 13
Label 11
Label 5
A, B, C
Label 4
Label 8
Label 6
Label 7
Label 9
16
Label 17
Label 10 Label 12
A, B, C, D, E

Label 13

Label Locations
Label 14 Label 15

Label Identification
LA SER
APE RT UR E
2-A,B,C
2 1 5 7 - 4 0- 8 0 6 1 R E V [ ]

CLASS 4
INVISIBLE LASER RADIATION
WHEN OPEN. AVOID EYE OR SKIN
EXPOSURE TO DIRECT OR
SCATTERED RADIATION.

5-A,B,C

7 and 13
H2O
8

PULSED LASER
CANDELA CORP., 530 BOSTON POST ROAD
WAYLAND, MA 01778 MADE IN U.S.A.
Model No. GENTLEYAG

Serial No. 9914-XXXX-YYYY
220-230V 3680 W
50/60 Hz Date of Manufacture
APRIL 2004

Label Identification This product may be covered by one or more of the

following U.S. patents:
INVISIBLE LASER RADIATION 6,200,308 6,059,772 6,041,787 6,032,675 6,026,816

AVOID EYE OR SKIN EXPOSURE 5,979,454 5,814.040 5,810,801 5,599,342 5,598,426 E
TO DIRECT OR SCATTERED RADIATION 5,400,791 5,360,425 5,312,395 5,287,380 5,109,387
CLASS 4 LASER PRODUCT 5,066,293 4,887,600 4,829,262 6,171,301,B1
(Per EN60825-1: 2002-07)
Complies with FDA performance
MAXIMUM PULSE ENERGY 80 J standards for laser products except
PULSE WIDTH 0.25 - 300 ms for deviations pursuant to Laser
WAVELENGTH 1064 nm
Notice No. 50 dated July 26, 2001.
AIMING BEAM
CLASS 1
MAXIMUM POWER 5 mW
PULSE WIDTH CW
WAVELENGTH 520-550 nm
0123
A C D
B
10-A,B,C,D,E

Label
Label
LabelIdentification
Identification
Identification
14 11
12

7122-00-_______________
REV ________________
S/N ________________
15
16 17

Mains Power Symbols The mains power switch is Located on rear of the system and is marked with "│" and
" O ".
The "│" indicates the switch position in which the system is connected to the mains.
The “O" indicates the switch position in which the system is disconnected from the
mains.
The on the ID label indicates that the system operates on alternating

current.
Keylock Switch
The keylock switch symbol means “off” only for a part of equipment. When
Symbols the keylock switch is in this position, all circuits have been de-energized with the
exception of the keylock switch circuit itself.
The keylock switch symbol means “on” only for a part of equipment. When
the keylock switch is in this position, all circuits are energized and the device will be
fully functional.
The keylock switch symbol means “start”. This is a spring-loaded keylock

switch position. It is used to initiate the system operation. This position does not
initiate the release of laser energy.


Section 8
Accessory List

Packing List
Description Quantity
GentleYAG (or GentleYAG LE) Laser System 1

Fiber Pole 1
Footswitch (15 foot) 1
Accessory Kit (includes)
 Treatment Guidelines 1
 Operator‟s Manual 1
 Eyewear Selection Table 1
 Replacement Window Kit (Qty 25) 1
 Label Kit 1
 Physician Spectacle 1
 Physician Goggles 1
 Patient Goggle 1
 Key Ring w/Candela Tag 1
 Canister Empty Valve 1
 Laser Warning Sign 1
 Service Information Label 1
 CE Declaration of Conformity 1
 EC Certificate 1

GentleYAG Delivery System (includes)

 1.5/3mm Delivery System with DCD 1
 6/8/10 mm Delivery System with DCD 1
 1.5/3mm DX Gauge Kit 1
 8mm DX Gauge Kit 1
GentleYAG LE Delivery System (includes)

 3mm Delivery System with DCD 1
 3mm DX Gauge 2
Available Options with DCD:
GentleYAG HR Delivery System



GentleYAG SRT Delivery System

GentleYAG VR Delivery System

GentleYAG HR/SRT Delivery System

GentleYAG HR/VR Delivery System


GentleYAG SRT/VR Delivery System

Description
DCD Option (includes)

 DCD Assembly 1
 12 Pack of Cryogen 1
 DCD Cap 1
DCD Canister Warmer


Section 9
Service
Internal
Calibration
Procedure
Note
The procedures contained in this section are service procedures, to be

performed by appropriately trained technicians. They are not to be performed
by the user.
CAUTION!
DURING SERVICING OF THE GENTLEYAG LASER SYSTEM CAN BE
EXTREMELY DANGEROUS IF PROPER SAFETY PRECAUTIONS ARE
NOT TAKEN. THE GENTLEYAG LASER SYSTEM IS TO BE SERVICED
ONLY BY QUALIFIED TECHNICIANS WHO HAVE RECEIVED
APPROPRIATE TRAINING FROM CANDELA. ANY ATTEMPT BY AN
UNAUTHORIZED PERSON TO PERFORM ANY SERVICE PROCEDURE
WILL VOID ANY WARRANTY ON THE LASER SYSTEM.
INTERNAL The measurement circuits should be calibrated annually to insure accurate delivery of
treatment energy. Measurement circuit calibration should be performed by a
CALIBRATION qualified Candela Service person as part of a “preventative maintenance” visit.
During the visit, other subsystems of the laser system will be inspected, adjusted (if
SCHEDULE necessary) and/or repaired as required. Contact Candela Customer Service for details
on “preventative maintenance” or a service contract (if available).

In normal operation, the Calibration procedure is provided for the user to calibrate the
PREFACE energy output of the laser system. During that procedure, the handpiece is inserted in
the calibration port, the laser is pulsed, and the energy output of the handpiece is read
by internal laser energy detectors. The system determines the high voltage level
necessary to provide the correct delivered energy for the currently selected energy
density setting.
The internal laser energy measurement circuits themselves must be calibrated at least
once a year by a qualified service technician. The internal energy calibration
procedure is described in this section. The procedure requires an external laser energy
meter whose calibration is traceable to the appropriate national standards agency.
The external laser energy meter used must be appropriate for the specified output of
the laser system, with an accuracy of ± 6% or better, and a resolution of 10mJ. This
procedure is part of the normal preventive maintenance service procedure.
There are five major steps that must be done to complete this procedure properly:
1. Starting the Circuit CAL procedure
2. Laser Head (HD) Circuit CAL (0-120J, 0-20J ranges)
3. Cal Port (CP) Circuit CAL (0-120J, 0-20J ranges)
4. Verification of Circuit CAL factors
5. Final verification of User Calibration Energy
1. Energy meter (OPHIR with L40(150)A head)

PARTS LIST 2. Any known good Delivery System with a clean window except 3mm or
1.5/3mm.

CAUTION!
Make sure all personnel in the area are wearing safety eyewear appropriate for
the GentleYAG Laser System.
Improper internal calibration of this laser system will cause delivery of lower or
higher fluences and potential burning of patients. This procedure must be
followed precisely for proper results. If the “Final verification of User
Calibration Energy” section fails, contact Candela Customer Service for further
information.
Once the Circuit CAL procedure has been started, the previously saved CAL
parameters will be erased. The Circuit CAL procedure must be completed in
order to use the laser for treatment again.
INTERNAL STARTING THE CIRCUIT CAL PROCEDURE
CALIBRATION 1. Set the DCD prespray and postspray to 0. From the Main screen, go to the
Laser Variable Mode (LVM) screen by pressing and holding the Next
Screen (right arrow) button for at least two seconds.
2. Press the Circuit CAL button and a pop-up keypad will appear.
Enter the eight digit access code of 12357111. The Circuit CAL screen
should now be shown.
3. Install the delivery system. Set the slider for 8mm, 12mm, or 15 mm.
NOTE: When pulsing into the Ophir energy meter, the meter head
must be 6” from the handpiece to prevent damage to the meter head.
4. There are 3 typical icon screens (shown at left) that are displayed during
each of these Circuit Cal‟s and they are described below.
1) Pulse into the Ophir meter
Pulse once when the HVr and HVs voltages are within 20V of each
other.
The handpiece is directed into the Ophir meter
2) Enter the Ophir energy using keypad
Always enter to two decimal places.
3) Pulse into Cal Port
Note the HVr (reference or set voltage), HVs (sample or actual voltage), HD
(Laser Head energy [J]), CP (Cal Port energy [J]) are displayed to the right of
each screen.
LASER HEAD (HD) CIRCUIT CAL (0-120J, 0-20J RANGES)
The Circuit CAL basically pulses the laser into an external meter and then into
the systems Cal Port at a low and high energy to calculate a slope and offset
difference between the two. There are three steps that are completed during the
0-120J Circuit CAL. First, the energy measurement circuit pregain (PreG) is
measured at a low energy, then a low point (LoPt) energy is measured, and
finally a high point (HiPt) energy is measured to allow for calculation of the

slope and offset. The 0-20 Circuit CAL uses the pregain from the 0-120J range
so only requires the LoPt and HiPt measurements.
5. Press the “0-120J” button beneath the “HD” column for 1 second to begin
the HD circuit calibration procedure. The system enters Ready
automatically.
6. The screen will prompt the user (with Icons) when to pulse the laser into
the Ophir energy meter, when to enter the Ophir meter reading (using the
keypad), and when to pulse into the calport.
NOTE: Set the Ophir meter on the 30J range. After completing the LoPt,
change the Ophir meter to the 100J range.
7. On completion, the laser “dumps” (popping sound) the stored energy and
the screen displays “SUCCESSFUL HD CAL”
8. Press the “0-20J” button beneath the “HD” column for 1 second to begin
the HD circuit calibration procedure.
NOTE: Set the Ophir meter on the 30J range for this entire CAL.
the screen displays “SUCCESSFUL HD CAL”

CAL PORT (CP) CIRCUIT CAL (0-120J, 0-20J RANGES)

The Circuit CAL basically pulses the laser into an external meter and then into
the systems Cal Port at a low and high energy to calculate a slope and offset
difference between the two. There are three steps that are completed during the
0-120J Circuit CAL. First, the energy measurement circuit pregain (PreG) is
measured at a low energy, then a low point (LoPt) energy is measured, and
finally a high point (HiPt) energy is measured to allow for calculation of the
slope and offset. The 0-20 Circuit CAL uses the pregain from the 0-120J range
so only requires the LoPt and HiPt measurements.
11. Press the “0-120J” button beneath the “CP” column for 1 second to begin
the CP circuit calibration procedure.
NOTE: Set the Ophir meter on the 30J range. After completing the LoPt,
change the Ophir meter to the 100J range.
the screen displays “SUCCESSFUL CP CAL”
14. Press the “0-20J” button beneath the “CP” column for 1 second to begin
the CP circuit calibration procedure.

NOTE: Set the Ophir meter on the 30J range for this entire CAL.
the screen displays “SUCCESSFUL CP CAL”
VERIFICATION OF CIRCUIT CAL FACTORS
The Circuit CAL for all internal energy circuits has now been completed. The
energy circuit factors should be verified prior to exiting the Circuit CAL
screens. The Factors screen displays all the pertinent Circuit CAL factors as well
as provides a Test button to ensure that the Circuit CAL‟s were done properly.
17. Press the Factor button.
18. Verify the pregain is not exactly 15000, and is between 12000 and 25000.
19. Verify that the slope (m factor) for both ranges of the HD and CP are 1 +-
10% and that the offset (b factor) for both ranges of the HD and CP are 0 +-
15%.
20. Verify the Aper Factor is 0.700 +-20%.
21. Press the Test button. Verify that “Pass” is displayed in all eight locations.
22. If any of these verifications fails, the Circuit CAL needs to be repeated. If it
fails more than once, then contact Candela Customer Service for service.
FINAL VERIFICATION OF USER CALIBRATION ENERGY

The final step is to complete user calibrations and to verify the energy is within
specification.
23. Press the Exit button. This will return the user to the Main user screen.
24. Complete the following Calibrations using the specified spot size, fluence,
and pulse width from the tables below. After each Calibration, enter Ready
and Pulse 3 times into the Ophir meter. Record each Ophir energy.
25. Calculate the Average Ophir energy and then the percentage difference
from the expected energy.
26. Verify the percentage difference of each table is within +-14%. If this
verification fails, the Circuit CAL needs to be repeated. If it fails more than
once, then contact Candela Customer Service for service.
15mm, 6.0J/cm2, 3ms 15mm, 44.0J/cm2, 3ms

Expected Energy = 10.6J Expected Energy = 77.7J
Pulse # OPHIR Energy, J Pulse # OPHIR Energy, J
1 1
2 2
3 3
Avg Avg
%Diff %Diff
The following test is not required for “LE” systems.
10mm, 6.0J/cm2, 0.50ms 10mm, 12.0J/cm2, 0.50ms

Expected Energy = 4.7J Expected Energy = 9.4J
Pulse # OPHIR Energy, J Pulse # OPHIR Energy, J
1 1
2 2
3 3
Avg Avg
%Diff %Diff
27. Circuit Calibration is complete; the laser can safely be used.

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What are the safety precautions mentioned in the manual?

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Operator's

(EC Authorized Representative)

8501-00-1766 Revision F CONFIDENTIAL Page 2

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8501-00-1766 Revision F CONFIDENTIAL Page 4

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8501-00-1766 Revision F CONFIDENTIAL Page 6

Laser System Spot size

The Candela GentleYAG Laser system is a flashlamp-excited, Nd:YAG

8501-00-1766 Revision F CONFIDENTIAL Page 7

To provide energy to the flashlamp, a high-voltage power supply charges a storage

8501-00-1766 Revision F CONFIDENTIAL Page 8

The systems deliver laser energy at a wavelength of 1064 nm with a pulsewidth of

8501-00-1766 Revision F CONFIDENTIAL Page 10

FIGURE 1.1 Control

8501-00-1766 Revision F CONFIDENTIAL Page 11

8501-00-1766 Revision F CONFIDENTIAL Page 12

Laser Aperture &

8501-00-1766 Revision F CONFIDENTIAL Page 13

8501-00-1766 Revision F CONFIDENTIAL Page 14

Note: The distance gauge does not rotate when installed.

8501-00-1766 Revision F CONFIDENTIAL Page 15

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8501-00-1766 Revision F CONFIDENTIAL Page 17

8501-00-1766 Revision F CONFIDENTIAL Page 18

8501-00-1766 Revision F CONFIDENTIAL Page 19

The proper method to install the 1.5 mm is as follows:

8501-00-1766 Revision F CONFIDENTIAL Page 20

Refer to Section 6 of this manual for instructions on cleaning and maintenance of

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Weight 210 lbs (95 kg)

GentleYAG comply with 21 CFR 1040.10 and

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220 V - 230 V~ (+/-10%) 50/60 Hz, >16 Amp*, single phase,

*Note: GentleYAG Laser System may be suitable for hookup to

GROUND CONTINUITY TESTS

Sufficient floor space is required for the laser system. Approximately 15

Humidity of 20% to 80% (non-condensing) should be maintained in the laser room.

If it becomes necessary to relocate the GentleYAG Laser System, call Candela

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1. Identify the laser room clearly. Post appropriate warning signs in

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temporarily clouded vision, retinal lesions, long-term scotoma (vision absence in an

Handpiece Slider NOHD(m) per

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Maximum delivered energy per EN60825-1:2002 is 96 J.

Follow these precautions to ensure optical safety:

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