Smoothbeam Candela Corporation

0123
Operator's
Manual

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CAUTION!
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.

Federal (USA) law restricts this device to sale by or on the order of a physician.

Federal law also requires this device to be utilized under the direction of a physician and
it should be used by healthcare professionals authorized under state law to treat patients.
All persons treating patients with this device should check to determine whether they are
an authorized healthcare professional under the applicable state law.
(EC Authorized Representative)
Scanlan Group B.V.
Tupolevlaan 32
1119 NZ Schiphol-Rijk
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)

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Applications
Description
Specifications

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The Candela SmoothbeamTM system is a solid state diode laser indicated for use in
APPLICATIONS dermatology for incision, excision, ablation, and vaporization with hemostasis of soft
tissue. The Candela Dynamic Cooling Device (DCDTM) is an integral part of the
Smoothbeam. The DCD is indicated for pain reduction and cooling of the skin during
laser treatments and it allows for the use of higher fluences and reduction of potential
side effects of laser treatments

The Smoothbeam delivers pulses of laser energy at a wavelength that is absorbed by

water in the epidermis and dermis (1450 nm). The absorbed laser energy is converted
into heat, causing thermal injury to the tissue.

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The Smoothbeam (Figure 1.1) is a 1450 nm pulsed diode medical laser controlled by
DESCRIPTION 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 Smoothbeam system is a solid state pulsed diode laser which delivers energy at a
Laser System wavelength of 1450 nm. Laser energy is delivered through an optical fiber that is
attached to the handpiece. The handpiece contains the optics necessary to focus the
laser beam to a 4 mm spot. A replaceable distance gauge that is attached to the
handpiece ensures that the spot is focused at the skin and serves as the laser beam
aiming device.

The maximum delivered energy of the system is 3.14J in a 4 mm spot or 25 J/cm2.

This energy is generated by multiple laser diodes whose outputs are combined
together in the system’s internal laser diode box. The energy is delivered in four sub
pulses that are each separated by a DCD pulse. The delivered fluence may be
adjusted between (8 to 25) J/cm2 in 1 J/cm2 increments. The Smoothbeam system is
triggered on with a footswitch. When the footswitch is depressed, the laser repetition
rate will be 1HZ.

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Operation of the system without cryogen allows the system to operate in an ablative
mode. To use the system for ablative treatments the cryogen should be turned off, as
described in Section 3.

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FIGURE 1.1
LASER SYSTEM

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The laser system incorporates a skin cooling device built into the system enclosure
Dynamic Cooling referred to as the dynamic cooling device (DCD). The DCD consists of an electrically
controlled spray nozzle located at the treatment end of the handpiece and a cryogen
Device (DCDTM) reservoir canister and the associated electronic control circuitry located inside the
system enclosure.

The cryogen, GentleCoolTM, 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 five pulses of cryogen spray to be applied to the skin. One
pulse is prior to the first laser sub pulse, three pulses are sprayed between laser sub
pulses, and the final spray pulse is emitted after the last laser sub pulse. Controls are
provided on the laser front panel for the adjustment of the spray burst duration.

The delivery system (Figure 1.2) consists of a cable assembly, replaceable distance
gauge and a handpiece assembly. The cable assembly contains the optical fiber,
cryogen tubing and electrical signal wires. The handpiece assembly contains the
DCD spray nozzle, safety electronics and 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.

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FIGURE 1.2
ENTIRE DELIVERY
SYSTEM

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FIGURE 1.2
DELIVERY SYSTEM
CLOSEUP

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Laser Type Pulsed diode laser

SYSTEM Wavelength 1450 nanometers (nm)
SPECIFICATIONS Maximum Fluence 25 J/cm2 (DCD off)
20 J/cm2 (DCD on)
Maximum Delivered Energy 3.2 joules (J)
Table 1-1 Stability of Output Energy ±14%
Pulse Repetition Rate 1 Hz repetitive pulsing
Specifications Pulse Duration 250 milliseconds
Beam Spot Sizes 4 millimeters
Cooling Method Ambient air
Dimensions (HxWxD) 17”x23.5”x20” (43x60x51 cm)
Weight 39 lbs (18 kg)
Cryogen HFC 134a

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Table 1-2 lists Electrical Requirements for the Smoothbeam. Two line cords are
ELECTRICAL shipped with each laser system. One is for use on 115 VAC power systems and the
other is intended for 230 VAC power sources. The 115 VAC line cord should be
REQUIREMENTS connected to a Hospital Grade, NEMA 5-15R or 5-20R electrical receptacle, or
equivalent, is required. For Smoothbeam systems shipped internationally, if neither
of the supplied cords are suitable then the customer must obtain a cord. The cord
must meet the following requirements:
1. IEC 320 plug to connect to the IEC 320 receptacle on the back of the laser
2. Three conductor cord rated for 10 Amperes (3 x 18 mm2)
3. Cord length not to exceed 3 meters
4. Line cord must be labeled and approved by a nationally recognized test lab
(NRTL).

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USA 115 V~
TABLE 1-2 Europe 230 V~
ELECTRICAL Asia Pacific 100- 230 V~
(Maximum line-voltage variation 50/60 Hz, single-phase, 4.6A
REQUIREMENTS + 10%) @ 100 V, 2A @ 230 V (10 A
minimum service
recommended)

NOTE
Operation of the Smoothbeam on a power line that is not consistently
within these specifications may damage the system and will void the
warranty.

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Before installation of the Smoothbeam, the intended site must be prepared as

ENVIRONMENTAL described in this section. The site must have sufficient space to accommodate the
laser system, must provide the proper electrical power configuration and receptacles,
REQUIREMENTS and must meet the additional environmental specifications.

NOTE
Follow the installation video supplied with the Smoothbeam. Should you
have any questions, contact Candela.

SPACE Sufficient space is required for the laser system. Approximately 12 inches of
clearance is required between the rear panel and the wall, to allow room for the
REQUIREMENTS power cord and proper circulation of air from the cooling vents.

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

Ensure that the atmosphere is non-corrosive, with no salts or acids are in suspension
Air Quality in 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.

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Ambient A temperature between 65° and 85°F (19° and 29°C) should be maintained in the
laser room. Avoid placing the laser system near heating outlets or other sources of air
Temperature currents that could cause uneven cooling in the laser system.

Relocation The Smoothbeam has been designed for desk top use. Care should always be taken
when moving the system. It may be moved by caring or transported on a cart
avoiding thresholds and other floor surface obstructions. Always re-pack the system
in the ‘original” packaging before transporting. A severe physical shock could cause
the alignment of optical components to be disturbed resulting in personal injury or
physical damage.

Portability The Smoothbeam has been designed for desk top use.

Storage The laser system must be stored at an ambient temperature between 40° and 110° F
(5° and 43° C) and humidity of 20% to 80% (non-condensing).

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Hazards
Precautions
Safety Features

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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 Smoothbeam is in operation, restrict entry and limit access to the
laser room only 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.

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.

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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 SMOOTHBEAM CAN BE EXTREMELY
DANGEROUS AND SHOULD BE SERVICED ONLY BY THOSE QUALIFIED
TECHNICIANS WHO HAVE RECEIVED APPROPRIATE TRAINING ON
THE SMOOTHBEAM FROM CANDELA.

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CAUTION!
USE ONLY SAFETY EYEWEAR WITH AN OPTICAL DENSITY OF ≥2.7 @
OPTICAL 1400-1500 NM.

PRECAUTIONS
The laser beam emitted by the Smoothbeam is capable of causing loss of vision. The
laser operates at 1400-1500 nm, which falls within the visible spectrum. The cornea
and lens of the eye are transparent to visible light. Any energy emitted by the
Smoothbeam 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 Smoothbeam is at the distal end of the handpiece. The beam
enlarges as the 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 half 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
Smoothbeam must wear appropriate eye protection available from Candela.

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Handpiece Spot Diameter, mm Half Angle Beam NOHD,meters

Table 2-1 Divergence, radians
NOHD/ Handpiece 4 0.07 0.52
Comparison

CAUTION!
THE LASER BEAM EMITTED BY THE SMOOTHBEAM SHOULD NEVER
BE DIRECTED AT ANY PART OF THE BODY OTHER THAN THE
INTENDED SITE OF TREATMENT OR TESTING.

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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 Smoothbeam is not in use, place it in STANDBY state to prevent
accidental pulsing.
7. When the Smoothbeam is unattended, remove the key from the keyswitch to
prevent unauthorized use.
The Smoothbeam converts and amplifies the AC line voltage to produce high
ELECTRICAL 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 off, and even
& MECHANICAL after the Smoothbeam has been disconnected from the line voltage. Therefore, no
HAZARDS part of the exterior housing should be removed, except by a trained and authorized
technician.

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The Smoothbeam laser delivery system utilizes 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 4.5 inches 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.

CHEMICAL NOTES to Physicians

• Because of possible disturbances of cardiac rhythm, catecholamine drugs,
HAZARDS such as epinephrine, should only be used with special caution in situations,
of emergency life support.
Cryogen • Possible risk of cardiac sensitivity if exposed to a high concentration of
cryogent gas.
• Possible frostbite or related injury if you come in contact with a large
concentration of cryogen gas.
• Canister is under pressure, if it is leaking the risk of the canister exploding
is minimal.

Cryogen Hazard Response:

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.

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Skin Contact: In case of skin contact, immediately flush skin with plenty of water
for at least 15 minutes, while removing contaminated clothing and shoes. Call a
Physician. Wash contaminated clothing before reuse. 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.

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.

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The Smoothbeam was designed to comply with IEC 601-1-2 (Group 1, Class A)
ELECTRO- "Electromagnetic Compatibility Requirements and Tests". Class A equipment is
intended for use in commercial and industrial locations. A portion of IEC 601-1-2
MAGNETIC deals with measurements of unwanted radio frequency emissions generated from a
INTERFERENCE 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 Smoothbeam have been reduced as far
as practical without compromising functionality.
If interference from the Smoothbeam is suspected, insure that the unit is plugged into
an AC Mains that is not shared by the affected equipment. If the interference still
exists, move the Smoothbeam or the affected equipment into another room.

Keylock Switch
SAFETY
This key-operated switch controls electrical power to the laser system. The
FEATURES Smoothbeam 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 Stop Switch (Emergency Off)
When this red switch (located on the lower left side of the control panel) is pressed,
the Smoothbeam is shut down immediately.

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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 foot 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 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 below the control panel is illuminated.
Upon entering ready, an audible beep indicates that the next trigger action will
release laser energy. If the laser is being pulsed repetitively, the system will emit a
beep simultaneously with every pulse and the word “LASING” is displayed on the
control panel.

Remote (CDRH) 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 Smoothbeam is in the Ready state, the laser
system completely shuts down. For more information on installation of a remote
interlock, please call Candela Service.

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System Operation
Features

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The Smoothbeam control panel is located on the left side of the laser system. It
CONTROL consists of an On/Off keylock switch, a Laser Stop (emergency off) push-button
switch, and a Touch Screen Display Panel (Display Panel). The Display Panel
PANEL (Figure 3.1) provides a simple graphical user interface for the operator. The operator
uses this interface to select the system operating state, laser operating parameters,
SWITCHES DCD parameters and output energy calibration.

Keylock Switch
This key-operated switch controls electrical power to the laser system. The
Smoothbeam 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 ON position to the START
position, then release. The switch returns to the ON position once the laser system
starts.

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 START position, and then
release.

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Figure 3.1
Touch Screen STANDBY
Button READY
Display Panel Button

FLUENCE
DCD
SPRAY
PULSE COUNTER
CANISTER
COUNTER

CALIBRATE NEXT Screen

Button Button

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Figure 3.2
Next Screen

PURGE SWITCH

LANGUAGE
SELECT

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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, laser diode emission is disabled.

Standby
The operator selects the STANDBY state by pressing the STANDBY button. The
background for the Standby button is set to YELLOW to indicate that this state is
selected. The word “STANDBY” is also displayed in the top portion of the Display
Panel.
The Smoothbeam automatically enters STANDBY state following the initial
warm-up period which occurs when the laser system is first powered up.
If the laser has not been pulsed for three 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.

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When in the READY state, laser emission is enabled. This state is selected by
Ready/ pressing the READY button. The background for the title text of the READY button
Ready is set to YELLOW to indicate that this state is selected. A two second delay is
implemented before laser emission is enabled when the system state changes from
Indicator 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 Figure 6.4 for the location of the Ready
indicator.
The window area below the System Status menu bar contains the buttons associated
with the Main Menu when the operator has selected this menu via the NEXT button
as described above.

The laser operating parameters; Fluence and DCD Spray can each be set individually
OPERATING by the operator. To 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
PARAMETERS selected parameter is set to black to indicate that their numeric settings can be
modified.

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Fluence The Fluence parameter is the amount of energy density delivered to the
selected spot size. The setting is adjustable in increments of 1.0 J/cm2 between the
lower and upper values:

4 mm Spot Size 8.0-25.0 J/cm2

To ensure that the selected energy density is delivered, the laser will automatically
require that a calibration procedure be performed if the Fluence parameter has been
changed. The Fluence parameter last selected is retained in memory when the laser
system is turned off. Table 3.1 contains the fluence and associated energy readings.

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CAUTION!
SHADED FLUENCES/ENERGIES ARE FOR “ABLATIVE” MODE ONLY.

Table 3-1 Fluence Delivered

J/cm2 Energy (J)
Fluence/Energy
8 1.00
9 1.13
10 1.26
11 1.38
12 1.51
13 1.63
14 1.76
15 1.88
16 2.01
17 2.14
18 2.26
19 2.39
20 2.51
21 2.64
22 2.76
23 2.89
24 3.01
25 3.14

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The DCD Spray parameter adjusts the duration of the cryogen spray applied to the
DCD Spray patient. The DCD Spray may only be used in “non ablative mode”, that is fluences
between 8-20J/ cm2. In this mode, the DCD spray quantity may be selected from (1)
minimum to (5) maximum. The (0) off setting is for ABLATIVE MODE ONLY.

Method for Selecting Cryogen Setting:

Non-ablative Mode:
• Press the Cryogen display button until it is highlighted.
• Press the UP or Down display button until the desired setting is displayed
(1 through 5).
• The maximum allowable fluence in Non-ablative mode is 20 J/cm2.
Ablative Mode:
• Press the Cryogen display button until it is highlighted.
• Press the Down arrow display button until the setting of “1” is displayed,
then continue to press and hold the down arrow display button for
approximately 3 seconds.
• “Ablation Mode See Operator’s Manual” will be displayed. For ablative
treatments press “OK” and “0” will be displayed on the screen indicating
no cryogen will be used.
• In the ablative mode fluences of 8 through 25 J/cm2 may be selected.
• To resume to non-ablative mode with the use of cryogen, with the Cryogen

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display button Highlighted, press the “UP” display button until the desired
cooling setting is displayed.
• If the fluence setting was above 20 J/cm2 when leaving the Ablative Mode,
the software will automatically lower the fluence to 14 J/cm2.

CAUTION!
SETTING “0” IS FOR ABLATIVE MODE ONLY. NO CRYOGEN IS SPRAYED
IN THIS MODE. HOLD THE DOWN ARROW FOR APPROXIMATELY 3
SECONDS TO ENTER ABLATIVE MODE.

IF IN NON-ABLATIVE MODE AND CRYOGEN DOES NOT SPRAY,

DISCONTINUE THE USE OF THE LASER AND CALL SERVICE.
Spray Setting Total Duration of
Number Spray (ms)
1 40
2 50
3 60
4 70
5 85
0 0

When the DCD Spray parameter is changed, the remaining number of spray pulses
displayed on the CANISTER COUNT button is automatically adjusted .

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The Display Panel contains two system Counter/Reset buttons; the Pulse
SYSTEM COUNTERS Counter/Reset button and the Cryogen Counter/Reset Switch
The Pulse Count parameter indicates the number of times the laser has been pulsed.
This counter can be used to keep track of the total number of laser pulses used in a
Pulse Count/ treatment session.
Reset
The Pulse Count is reset to zero by pressing the PULSE COUNT button for
approximately 4 seconds. The system acknowledges the selection by responding with
a short beep tone and by displaying “0” within the PULSE COUNT button.
The Canister Count parameter indicates the total number of DCD Spray pulses
Canister Count/ remaining in the cryogen canister for the selected spray duration.
Reset
When the counter reaches zero, the cryogen canister will be almost empty. A warning
message window will prompt the operator to replace the cryogen canister. For safety
reasons, it is normal for about 10% of the cryogen to be left in the can when the
counter reaches 0. (This is due to the design of the can, which does not allow full
evacuation of the cryogen without a significant reduction in cryogen flow rate.) Once
the canister is replaced, the operator must reset the Canister Counter to the “full”
canister value manually by pressing the CANISTER COUNT button for
approximately 4 seconds. The new canister will require approximately 30 minutes
warm-up time before the system can be used.

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The Smoothbeam has been design in conjunction with the 1000 gram cryogen
canister only. Do not use other sizes.

CAUTION!
FAILURE TO INSTALL THE APPROPRIATE SIZE CANISTER FOR YOUR
LASER OR FAILURE TO REPLACE IT WHEN PROMPTED BY THE SYSTEM
CAN LEAD TO ADVERSE PATIENT TREATMENT RESULTS INCLUDING
BURNS.
THESE 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 SPOT SIZE AREA
ALWAYS REPLACE THE CANISTER WHEN THE SYSTEM INDICATES
“REPLACE CANISTER” OR EQUIVALENT.
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
GENTLECOOL CANISTER. ONLY INSTALL THE APPROPRIATE SIZE
CANISTER AS INDICATED BELOW:

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After the canister has been installed, the system acknowledges the selection by
responding with a short beep tone and by setting the count value displayed within the
CANISTER COUNT button to the number of counts available from a full canister of
cryogen. (This value depends on the preset value of the DCD SPRAY selected)

Spray Setting
Figure 3.3 Number
Approximate
Pulses Available
DCD Pulses 1 8050
2 6550
3 5602
4 4800
5 3951

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OTHER The calibration procedure is initiated by pressing the CALIBRATE button. Note that
the system will initiate the calibration procedure automatically if READY state is
CONTROLS entered, a calibration is required, and the handpiece is inserted into the cal port.
After calibration, the system is in READY state and the trigger switch is enabled. The
Calibrate Button operator can switch between READY state and STANDBY state as needed without
recalibrating provided that the fluence and pulse width parameters have not been
changed and no more than thirty minutes has elapsed since the last calibration.

Triggerswitch Laser emission is generated by depressing the triggerswitch (footswitch), provided

the system is calibrated

When the trigger switch is pressed, DCD Spray (if DCD Spray is on) and laser pulses
are delivered at the distal end of the handpiece.
The trigger switch must be pressed to its limit and released to deliver a single laser
and DCD Spray pulse. To deliver continuous laser pulses and DCD pulses, the trigger
switch must be pressed to its limit and held.

The purge switch is used to remove air or bubbles from the handpiece assembly. This
Purge Switch may be required when a new canister is placed in the system.

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The language select switch displays messages in the selected language. Press the
Language Select down or up arrow to select the desired language.

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 may remain attached to the handpiece, but must be cleaned and
dried before the handpiece is placed in the calibration port.

Remote (CDRH) The remote interlock connector, located on the upper rear panel, may be connected to
one or more switches on the laser room door(s). When interlock is connected, the
Interlock laser system shuts down if laser room door(s) are 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.

Footswitch The footswitch connector is located on the rear panel of the laser system.
Connector

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The on/off mains switch is located on the rear panel of the laser system and must be
On/Off Mains Switch in the ‘1’ (on) position for the laser system to operate. Always place the on/off mains
switch in the ‘0’ (off) position when the laser is not in use.

Software Access Door The software access door located on the underside of the laser system allows
the operator to change the system software when future updates are received. The
system software is stored on a small printed circuit board and is easily removable.
The system will not work properly without a software board inserted. See Figure 3.4
for location of software access door.

CAUTION!
THE SOFTWARE CARD IS SUBJECT OT DAMAGE FROM STATIC
DISCHARGE IN HANDLING. AVOID CONTACT WITH THE COMPONENTS
ON THE CARD AND THE ELECTRICAL CONTACT POINTS. HANDLE THE
CARD BY HOLDING THE EDGES OF THE CARD WITH FINGERS AND/OR
THE WHITE PLASTIC GRIPS.

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To remove the existing software board, first turn the on/off mains switch to the ‘0’
position. Remove the AC power cord and also remove the delivery system cable.
Take out all items from the accessory compartment and then attach a piece of tape
over the compartment lid to hold it in place when the system is picked up. Carefully
lift up the system from the front and hold it up with one hand while letting the weight
of the system rest on the rear panel. Turn the screw on the software access door
counter clockwise to open the door. Grab the handle on the software board and pull it
out.
To install a new software board, carefully insert it into the system making sure the
edges of the board are lined up in the slides as it is pushed in. It may need a firm push
at the very end to seat the connector into the main system circuit board inside the
laser. Close the software access door and turn the screw clockwise to secure the door.
Make sure the software door is fully closed when the screw becomes hard to turn. If
it is not, then the software board is not fully inserted. Let the system down and attach
the delivery system cable and AC power cord. Turn the on/off mains switch to the ‘1’
position. Turn the keyswitch to power on the laser and verify that the display lights
up and the system begins warm-up mode.

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CAUTION!
TURN OFF THE LASER BEFORE OPENING THE ACCESS DOOR AND
REMOVING SOFTWARE BOARD.

Figure 3.4
SOFTWARE
ACCESS DOOR

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System Start-Up

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1. Cover windows with an opaque material to prevent unintended viewing.

LASER SYSTEM 2. Post laser warning sign near each entrance to the laser suite.
START-UP 3. Ensure an adequate number of protective eyewear is available. Proper eyewear
will filter light at a wavelength of 1400-1500 nm with an O.D. of 2.7 or greater.
4. Plug the laser into the correct electrical outlet. Ensure that the main circuit
breaker on the lower rear panel is in the “1” position.
5. Verify that the fiber connector at the laser is tight and secure.
6. Start the laser by turning the key to the start position and release. The system
will now enter the warm-up state (approx. 30 min). After the warm-up the
system will enter the STANDBY state.
7. Calibrate the laser fluence to be delivered to the patient:
a. Select the FLUENCE parameter on the control panel.
Non-Ablative Mode: Less than 20 J/cm2
b. Clean and dry the distance gauge.
c. Insert the handpiece into the CAL port until it clicks into place and stops.
d. Press the CAL switch and follow the instructions on the control panel
display. Remove calibrated handpiece.
8. Select the DCD Spray setting. (See Section 3)
9. Perform treatment. Place the laser into STANDBY after use. Document laser
use.

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NOTES
• To return the pulse counter to zero, press the PULSE COUNT button for
3 - 5 seconds.
• A calibration will automatically be required when:
1) Laser is turned on;
2) FLUENCE parameter is changed;
3) Specific faults occur;
4) 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.
2) Replacing the delivery system.

CAUTION!
FAILURE TO INITIATE A CALIBRATION AFTER CLEAN/REPLACING
THE WINDOW OR DELIVERY SYSTEM MAY RESULT IN THE DELIVERY
OF EXCESSIVE LASER ENERGY.

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Calibrate
Procedure

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CAUTION!
FAILURE TO PERFORM A CALIBRATE AFTER A FIBER OR WINDOW
HAS BEEN CLEANED OR REPLACED, CAN RESULT IN DELIVERY OF
FLUENCES GREATER THAN SPECIFIED ON THE CONTROL PANEL.

The Smoothbeam requires that the laser be calibrated prior to patient treatment.
CALIBRATE During calibration, the handpiece is inserted into the Cal Port allowing an internal
energy meter to measure the laser output parameters delivered at the handpiece. The
PROCEDURE system adjusts itself until the desired output is obtained. Usually 3 - 7 laser pulses are
required before calibration is complete. The calibration procedure also tests the fiber
integrity.
• Select the desired Fluence value via the Display Panel.
• With the system in Standby, clean and dry the distance gauge then inspect
for burn marks. If burn marks exists, replace distance gauge.
• Insert the handpiece fully into the Cal Port until it stops.

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NOTE
The handpiece must be manually held in the Calport during calibration.
The Calport is not designed to secur the handpiece in the calibration
port. Failure to manually hold the handpiece in the calibration port may
result in the handpiece sliding out and being physically damaged.

• Press the CALIBRATE button on the Display Panel and follow the
instructions provided in the calibration message windows.

Pressing CANCEL allows the operator to return to the Main screen. The operator can
then adjust the laser output parameters as needed before continuing the procedure.

NOTE
If the desired Fluence cannot be reached, a Fault 6 will be displayed.
Decrease the fluence and perform another calibrate. When this happens,
the laser system is degraded and does not have sufficient energy to
calibrate properly. A dirty window on the handpiece 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 need a new fiber or new diode box.
Call Service for more information.

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Maintenance/
Troubleshooting

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CAUTION!
THE ELECTRICAL AND LASER RADIATION HAZARDS PRESENT WHILE
SERVICING THE SMOOTHBEAM CAN BE EXTREMELY DANGEROUS IF
PROPER SAFETY PRECAUTIONS ARE NOT TAKEN. THE SMOOTHBEAM
IS TO BE SERVICED ONLY BY QUALIFIED AND AUTHORIZED
TECHNICIANS APPROPRIATELY TRAINED BY CANDELA.

The exterior of the laser system may be cleaned with a soft cloth slightly moistened
CLEANING AND with a solution of mild soap and water. Do not use harsh detergents. To disinfect the
DISINFECTION exterior of the laser system, use a soft cloth moistened with hospital-grade
disinfectant. Turn the system off prior to cleaning.

To clean and disinfect the handpiece,

Handpiece • Wipe the exterior surface with a gauze pad moistened with a hospital grade
disinfectant towelette or solution. Take care to avoid contaminating the internal
optical surfaces of the handpiece. Whenever cleaning the handpiece with an
alcohol solution, dry the area thoroughly prior to beginning a laser procedure.

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The distance gauge is the only part of the handpiece to contact the patient. This a
Distance Gauge disposable item that should be replaced when signs of degradation or difficulty in
cleaning occur.

To Clean/Disinfect the Distance Gauge Assembly:

• Clean by wiping with a gauze pad moistened with alcohol, hospital grade
disinfectant or a 10% bleach solution, and allow to dry.
• Soak in disinfecting solution such as Cidex-OPA.

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CAUTION!
THE WINDOW ON THE END OF THE HANDPIECE MAY BECOME SOILED
Handpiece Window WITH NORMAL USAGE. TO ENSURE PROPER FLUENCE DELIVERY, IT IS
IMPORTANT TO INSPECT AND CLEAN THE WINDOW FREQUENTLY SO
DEBRIS DOES NOT GET BURNED INTO THE WINDOW SURFACE.

ALWAYS TURN OFF THE LASER SYSTEM WHEN A DELIVERY SYSTEM

IS CHANGED OR A HANDPIECE WINDOW IS CLEANED OR REPLACED.

WHEN HANDPIECE WINDOWS OR THE DELIVERY SYSTEM FIBER GETS

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

AFTER REPLACING A DIRTY OR BURNT DELIVERY SYSTEM, ALWAYS

RECALIBRATE.

AFTER REPLACING/CLEANING A DIRTY WINDOW, YOU MAY NEED TO

REDUCE THE FLUENCE TO OBTAIN PRIOR RESPONSE.

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To clean or replace the handpiece window: (refer to Figure 6.1)

1. Wear dustless gloves to prevent smudges or fingerprints on lens.
2. Turn the laser off. Window is held in front end of Handpiece body (item A)
with an o-ring retained by a molded groove. An access groove allows removal
on o-ring to clean window.
3. Working over a clean surface, remove the o-ring (item C) that is holding the
window (item B) in place. Use tweezers or a pointed object in notch (D) to
gently pull the o-ring towards the center of the window until the o-ring is free
from the groove.
4. Turn the handpiece upside down allowing the window to fall out. (If needed,
gently tap the side if the handpiece with your finger).
5. (Used windows only), Clean the windows in a 10% bleach & water solution,
mild soap and water or alcohol. Rinse thoroughly with clean water, and dry with
a lint free tissue.
6. Re-inspect the window and compare with the Window Acceptability Chart in
Figure 6.2. If unacceptable, replace the window.
7. Grasp the window by the edges and place it back into the handpiece 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 and gently push the o-ring fully into the groove being careful not to touch
the window.

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Figure 6.1 A
D
Handpiece Delivery B
C
System

Distance gauge not

shown for clarity.

LETTER DESCRIPTION
A Handpiece Delivery System
B Window
C O-ring
D Notched Access for O-ring Removal

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Acceptable Window Examples:

Figure 6.2
Window Acceptability
Chart

Unacceptable Window Examples:

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HANDPIECE See Figure 6.3 for handpiece assembly diagram.

• With the system turned off, remove the old handpiece from the laser system.
ASSEMBLY • Connect the fiber as follows (refer to Figure 6.4):
1. Push and hold the lever to the left.
REPLACEMENT 2. Carefully insert the fiberoptic connector into the fiber port until it
stops.
3. Hand tighten until it is secure by turning clockwise.

CAUTION!
PULL ON THE FIBER SLIGHTLY TO DETERMINE IF THE FIBER IS SEATED OR
IF PLAY EXISTS. IF THE FIBER IS NOT SEATED PROPERLY, DAMAGE TO THE
LASER HEAD COULD OCCUR

• Connect the cryogen input connector by pushing in the knurled connector while
pushing the connector in until it stops. Release the knurled connector.
• Connect the handpiece control connector.

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A C
Figure 6.3
Handpiece D
Assembly
E

LETTER DESCRIPTION
A Distance Gauge
B Handpiece
C Cryogen Input Connector
D Handpiece Control Connector
E Fiberoptic Connector

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Figure 6.4
Handpiece
Installation

STOP

1. 2. 3.
Ready Indicator

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CAUTION!
CYROGEN THE CONTENTS OF THE CRYOGEN CANISTER ARE UNDER PRESSURE.
READ THE MATERIAL SAFETY DATA SHEET (MSDS) AND THE LABEL
CANISTER ON THE CANISTER BEFORE HANDLING.

The canister should be inserted upside down in the top of the laser system and
REPLACEMENT threaded clockwise until it stops. Follow the instructions shipped with each
replacement canister

DISPOSAL The disposal of the canister can be achieved by contacting a waste disposal company
or completely emptying, via the instructions with each canister, and disposing in the
trash.

MAJOR If a major cryogen leak occurs, disconnect the delivery system from the laser or
remove the canister from the laser. Ventilate the room thoroughly and call Service to
CYROGEN correct the problem.
LEAK For additional information, refer to the MSDS sheets supplied with each cryogen
canister.

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CRYOGEN The Smoothbeam system incorporates a cryogen sensor as a backup safety feature
that is used to verify that the cryogen is delivered during each pulse of the laser
SENSOR TEST system when used in non-ablative mode. This operation of this sensor should be
check anytime there is a question that the cryogen is working properly, handpiece has
PROCEDURE been dropped, or every 18 months as follows:

• Place the delivery system on a flat surface aimed away from any individuals.
• Place the system in the READY state.
• Disconnect the Cryogen Input Connector (See Figure 6.3) and press the
connector against a flat surface, spraying the cryogen until the Purge fault
appears. If the fault does not appear, call Service.
• Connect the Cryogen Input Connector.

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SITUATION PROBABLE CAUSE SOLUTION

/SYMPTOM or INDICATOR
TROUBLE- The system The external interlock Check the remote CDRH
cannot be is defeated. interlock connection on the
SHOOTING turned on. rear panel. If connected to a
door, make sure the door is
closed.
The laser system rear Switch the rear power switch
power switch is in the to the "1" (on) position.
"0" (off) position.
The keylock switch Turn the keylock switch fully
was not fully engaged. clockwise to the start position
and release.
The power is not Reseat the power cable on the
connected properly. rear of the laser and at the
wall socket. Check wall
power outlet to make sure
power is available using a
lamp or similar device.
Laser pulses, The DCD spray setting Make sure the DCD spray
no distinct is set to zero “O” or setting is set 1 or above. Press
audible valve in handpiece is the Purge button and verify
cryogen malfunctioning. that cryogen is being sprayed.
sound is
heard or
visual mist is
missing.

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SITUATION PROBABLE CAUSE SOLUTION
/SYMPTOM or INDICATOR
TROUBLE- Purge Bubbles have been Press the purge switch until
Required detected in the cryogen problem resolves. If problem
SHOOTING line. persists, call Service.
Cryogen will Cryogen valve stuck Remove the cryogen canister
not stop ON. or disconnect the handpiece
spraying. assembly from the laser. Call
Service.
Cryogen Tubing breaks in the Remove the cryogen canister
leak. delivery system. or disconnect the handpiece
assembly from the laser. Call
Service.
Warm-up The cryogen Call Service.
time has temperature control
exceeded 60 circuitry failed.
minutes.
Ineffective System or Fiber is Perform a calibration
fluence degraded. procedure per Section 5. Call
response. Service if problem persists.
Replace There is insufficient Replace the cryogen canister
Canister cryogen in the canister; with a new canister supplied
Message by Candela; Depress the
Appears Canister Count switch for 5
seconds to reset the canister
count.

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SITUATION PROBABLE CAUSE SOLUTION

/SYMPTOM or INDICATOR
TROUBLE- Burning Treatment beam or Replace the distance gauge. If
plastic odor distance gauge are problem persists, call Service.
SHOOTING or burn misaligned.
marks on
distance
gauge.
Laser Footswitch connection Reconnect footswitch on rear
doesn’t pulse pulled off rear panel panel connector.
when connector.
footswitch is
depressed

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

FAULT MESSAGES the fault and retrying the previous operation can be successfully accomplished
without further faults occurring. If the fault message persists, call Service and report
the Fault Number. Fault processing automatically places the system into the Standby
state.

FAULT DESCRIPTION ACTION

Fault Fault 2 ROM Checksum Failure Call Service
Messages Fault 3 Shunt Fault Removing your foot from the
footswitch too quickly or bouncing
the footswitch pedal may cause this.
Reset fault and continue. If problem
persists, call Service.
Fault 4 Current Fault Reset fault and continue. If problem
persists, call Service.
Fault 6 Calibration Malfunction Make sure that the fiber is screwed in
tight in the fiber port. Check that the
window on the end of the handpiece
is clean. Lower the Fluence
parameter. If the problem persists
call Service.

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Fault 7 TEC Temperature Fault Make sure the air flow for the rear
cooling fans and front bottom of the
chassis are not blocked. If the
ambient temperature near the system
is above 85°F, try moving the system
to a cooler location. If problem
persists, call Service.
Fault 8 DCD Over Pressure Remove the cover that accesses the
cryogen canister and feel the can. If
the canister is warm, leave the cover
off for 5 minutes. If it’s cold, replace
the cryogen cover, turn the laser off
for 30 seconds and then back on.
System should then warm up
cryogen. If problem persists, call
Service
Fault 9 DCD Warm-up Timeout Turn the laser off for 30 seconds and
then back on. If problem persists, call
Service
Fault 10 Handpiece Fault Check the delivery system’s
electrical cable for proper connection
to the front of the laser. Remove the
connector and then reconnect it to see
if problem is solved. If not call
Service
Fault 12 Energy Out of Range Recalibrate the system. If fault
persists, call Service

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Fault 13 Trigger Switch Malfunction When pulsing the laser, firmly press
on the footswitch until the laser
pulses. If problem persists, call
Service.
Fault 15 Transmission Fault Make sure that the fiber is screwed in
tight in the fiber port. Check that the
window on the end of the handpiece
is clean. If the problem persists call
Service.
Fault 16 Cryogen delivery Fault Purge the cryogen. If problem
persists, call Service
Fault 17 Pulse Fault Recalibrate system. If problem
persists, call Service
Fault 18 Replace Canister Remove canister and replace with
new one. Reset DCD pulse counter.
If problem persists, call Service
Fault 19 Purge Required Purge the cryogen. If problem
persists, call Service

Candela will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other necessary information which will assist the customers
appropriately qualified technical personnel to repair those parts of equipment which are
designated by Candela as repairable.

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Labeling

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LABELS The Smoothbeam has been labeled in accordance with domestic and 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 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 more information is referenced in the Operator’s manual.

Label 2 Indicates the emission of laser energy from this device.
Label 3 If the fiber bundle is removed or loosened, laser radiation, in excess of
AEL class 1, will exit. This label is located inside the laser system on the
Fiber Coupler Housing.
Label 4 This label indicates where the fuse replacement information is located.
This label is located inside the laser system on the inside wall above the left
fan.

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Label 5 Multi-combined label.

a. Indicates the emission of laser energy from this device.
b. Indicates the degree of protection against electric shock and indicates an
ungrounded applied part.
c. Indicates laser emission characteristics and classification per the EN and
IEC standards.
d. Indicates that the user should consult the accompanying documents prior to
energizing this device.
e. Indicates that additional label information is contained in the operator’s
manual.
f. 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.
g. Indicates Footswitch hose connection location.
h. CE approval mark

Label 6 Displays the voltage and current requirements for the system, as well as the
manufacturing model number, serial number and date of manufacture.
Label 7 The Emergency Laser Stop Red Push Button will turn off the laser quickly.

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Label 8 Indicates a hot surface when unit is powered
Label 9 Indicates that laser light will be exiting from this device. This label is
wrapped around the fiber near the proximal fiber connector.
Label 10 If present, indicates that the laser is approved to UL or ETL standards.
Label 11 Indicates the wavelength, pulsewidth, maximum energy, and classification
of laser emissions from this device per United States agencies (CDRH).
Label 12 Indicates compliance with United States agencies governing laser
equipment.
Label 13 Directs operator to calibrate delivery system after cleaning or replacing the
protective window in handpiece.

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Label Identification

2157-40-4060 REV [ ]

2157-40-4060 REV [ ]

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2157-40-4060 REV [ ]
CAUTION
INVISIBLE LASER RADIATION
WHEN OPEN AVOID EYE OR SKIN
EXPOSURE TO DIRECT OR
SCATTERED RADIATION.

WARNING: CONSULT SERVICE

MANUAL FOR FUSE REPLACEMENT.
REPLACE ONLY WITH ORIGINAL TYPE
AND RATING.

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Label Identification

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PULSED LASER
CANDELA CORP., 530 BOSTON POST RD
WAYLAND, MA 01778 MADE IN U.S.A.
Label Identification 100 - 230 V~
Model No. SMOOTHBEAM
4.6 - 2.0 A
460 VA Serial No. 9914-0820-XXXX

Date of Manufacture
50/60 HZ
MARCH 11, 2001

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Label Identification
8

9
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ETL LISTED
MEDICAL ELECTRICAL
EQUIPMENT
PART 1; GENERAL
R

Label Identification REQUIREMENTS

L I ST ED US FOR SAFETY
XXXXXXX

CONFORMS TO UL STD 2601-1

10

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11

12

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13

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Label Locations

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8
Label Locations

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Label Locations

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

2157-40-4060 REV 9
INVISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE
TO DIRECT OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT
(Per IEC 60825-1:1998)

MAXIMUM PULSE ENERGY 5J

PULSE WIDTH 250 msec
WAVELENGTH 1450 nm

0123

REAR VIEW

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Accessory List

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Quantity Part Number

Delivery System with Distance Gauge 1 7122-00-2050
4 mm Distance Gauge 1 1301-00-7737
Distance Gauge Tool (Hex Balldriver) 1 5501-00-0630
Cryogen Canister 2 1600-00-0210
NEMA Line Cord for 115 VAC 1 6032-00-0330
IEC Line Cord for 230 VAC 1 6032-00-0340
Physician Eyewear (Glass) 1 8095-00-0390
Physician Eyewear (Plastic) 1 8095-00-0300
Patient Goggles 1 7121-00-7530
CDRH Laser Radiation Sign 1 2157-40-5010
IEC Laser Radiation Sign 1 2157-40-5000
Canister Empty Valve 1 3430-02-0010
Replacement Window Kit (5 pack) 1 7122-00-3007
Footswitch 1 5103-00-0040
Operator’s Manual 1 8501-00-1620
Key Ring w/Candela Tag 1 1301-00-3409
Key,Replacement,#548162 Switch 0 5105-00-0100

Options:
Canister Warmer 1 9914-00-2104

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Service
Internal
Calibration
Procedure

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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.

Candela recommends that these procedures be performed every 18

months to ensure continued compliant operation.

CAUTION!
THE ELECTRICAL AND LASER RADIATION HAZARDS PRESENT
DURING SERVICING OF THE SMOOTHBEAM CAN BE EXTREMELY
DANGEROUS IF PROPER SAFETY PRECAUTIONS ARE NOT TAKEN. THE
SMOOTHBEAM 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.

The Calibrate procedure is provided for the user to calibrate the 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 an internal laser

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energy meter. The system determines the current level necessary to select each
attainable energy density setting.
The internal laser energy meter itself must be calibrated at least once every 18
months by a qualified service technician. This calibration requires using 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 10
mJ. This procedure is part of the normal preventive maintenance service procedure.

1. IBM compatible computer.

PARTS LIST 2. Candela’s WinMaint software.
3. Energy meter (OPHIR with L40(150)A, FL250A or 10A-P head)
4. 9 pin to 9 pin cable.
5. Potentiometer adjustment tool.
6. Monochromater
7. Oscilloscope.
8. CPU/LSR IO PCB (7111-00-2370)

Note
PROCEDURE Use the same laser energy meter for all of the following laser energy
detector calibrations. Make sure all personnel in the area are wearing
safety eyewear appropriate for the Smoothbeam.

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1.0 CALPORT DETECTOR CALIBRATION

CALPORT AND
HEAD DETECTOR 1.1 Connect scope probes to the CPU I/O PCB as follows:
CALIBRATIONS Channel 1: Probe on TP20 HEAD, return on TP18, 2V/div
Channel 2: Probe on TP21 CALPORT, return on TP18, 2V/div
Timebase = 40 ms/div Trigger = CH 1, rising edge at 0.5 V
Completed _______________
1.2 On the front panel set the Fluence to 20 J/cm2. Verify the HP delivery
system is still installed.
1.3 Verify that you are still in NORMAL Mode. Calibrate the laser system.
Pulse the laser once into the calport. The signals must be four equal
pulses for the head and calport signals. Measure the fall and rise time on
one of these four sub pulses with the time base set to 5 ms. Verify that the
fall and rise times for the head and calport signals are below 5 ms.
Accept _________________ Reject _________________

1.4 Remove the scope probes from the system.

Completed _______________

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1.5 Enter MM Mode. In Toggle screen, verify that the energy readings are J
for Joules. Go to the PULSE screen and set it up as follows:
1.5.1 Go to SETUP, select DATA, and select the following
variables to display:
head_fluence cal_fluence xmission
1.5.2 Go to the SETUP menu and select GRAPH/STAT. Select the
head_fluence and the cal_fluence to do statistics. Verify
graphing is OFF. Exit the GRAPH/STAT window.
1.5.3 Click on RESET.
1.5.4 Go to the MODE menu and select NORMAL.
Completed _______________
1.6 Go to READY and push the down arrow to calibrate (always calibrate in
NORMAL mode).
1.7 Remove the HP from the calport and install the HP into the Ophir energy
meter holder. Pulse the laser 5 times and average the 5 energy readings
by filling in the following table.

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Pulse # OPHIR Energy, J

1
2
3
4
5
Average =

Put the HP back into the calport and adjust R207 if necessary until the cal_fluence,
displayed on the PULSE screen, is equal to the average OPHIR reading.
1.8 Click on RESET in the statistics window. Determine the cal_fluence
detector calibration error by pulsing 5 times into the calport (B), then
pulse 5 times into the Ophir meter and calculating the average (A). Fill in
the following table for each pulse, and calculate the error. Record the
OPHIR energies as displayed on the meter. The average calport reading
is the “mean’ value in the statistics window.

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Pulse # OPHIR Energy, J Calport Detector

Energy, J
1
2
3
4
5
Average = (A) (B)

% error = (B/A - 1) x 100 = __________________%

The error must be ± 2% or less. If not, repeat Steps 1.7 and 1.8.
Accept _________________ Reject _________________

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CALPORT DETECTOR VERIFICATION

1.9 Insert the handpiece into the calport.

1.10 Adjust the fluence to 8 J/cm2 and calibrate. Remove the HP from the calport
and install into the Ophir energy meter holder. Click on RESET in the
Statistics window. Determine the low energy error by pulsing 5 times into
the calport (B), then pulse 5 times into the Ophir meter (A), filling in the
following table and calculating the error:

Pulse # OPHIR Energy, J Calport Detector Energy,

J
1
2
3
4
5
Average = (A) (B)

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% error = (B/A - 1) x 100 = __________________%
The error must be ± 7% or less.
Accept _________________ Reject _________________
2
1.11 Adjust the fluence to 25 J/cm and calibrate. Remove the HP from the
Calport and install into the Ophir energy meter holder. Click on RESET.
Determine the high energy error by pulsing 5 times into the calport (B), then
pulse 5 times into the Ophir meter (A), filling in the following table and
calculating the error:

Pulse # OPHIR Energy, J Calport Detector

Energy, J
1
2
3
4
5
Average = (A) (B)

% error = (B/A - 1) x 100 = __________________%

The error must be ± 6% or less.
Accept _________________ Reject _________________

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1.12 HEAD DETECTOR CALIBRATION

1.12.1 Adjust the fluence to 20 J/cm2 and calibrate. Adjust R204

Head Energy potentiometer and pulse the laser until the
transmission displayed on the computer screen is 80% +/-
0.5%.
Completed_____________

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