8501-00-9080 - F - 01 (1) User Manual

Laser System
03-FEB-20
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 or other
practitioner licensed by the law of the state in which he/she practices the use or order the use
of the device.
Federal law and some international laws also require that this device be utilized under the direction of
a physician. This device should only be used by healthcare professionals authorized under US state or
international law to treat patients. All persons treating patients with this device should determine
whether they are authorized healthcare professionals under the applicable US state or international
law.
© 2019 Candela Corporation. All rights reserved. This material contains registered trademarks,
trade-names and brand names of Candela Corporation and its affiliates, including Candela, Vbeam,
Vbeam Prima and GentleCool. All other trademarks are the property of their respective owners.
Catalog Part Number: 8501-00-9080
Revision: F
Publication Date: January 2020
EC Authorized Representative in the European Community

Scanlan Group B.V. Aalsmeerderweg 610
1437 EJ Schiphol-Rozenburg The Netherlands
Phone: +31 (0) 20 653 0553
Fax: +31 (0) 20 653 3053
Manufactured by: Candela Corporation

530 Boston Post Road
Wayland, MA 01778-1886, USA
Phone: +1 (508) 358-7637
Toll Free: 1 (800) 733-8550 (Technical Assistance)
Toll Free: 1 (800) 73-LASER (Customer Service)
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03-FEB-20
Table of Contents
Section 1: The Vbeam Prima Laser System 1
Applications ........................................................................................................................................ 1
System Description............................................................................................................................. 2
Laser System ................................................................................................................................. 2
Dynamic Cooling Device (DCDTM) ................................................................................................. 4
DCD Delivery System Handpiece .................................................................................................. 4
EverCool Delivery System Handpiece ........................................................................................... 5
Tips and Distance Gauges ............................................................................................................. 5
DCD Delivery System Smart Gauges .......................................................................................... 5
Locking/Swivel Wheels................................................................................................................... 5
Fiber Support Pole ......................................................................................................................... 6
System Specifications ........................................................................................................................ 7
Vbeam Prima Laser System Specifications ................................................................................... 7
Medical Electrical Equipment Standard Specifications and Classification ..................................... 9
Electromagnetic Compatibility (EMC) .......................................................................................... 9
Regulatory Classifications............................................................................................................ 9
Electrical Requirements ..................................................................................................................... 9
Installation Site Electrical Service Requirements ......................................................................... 10
USA ............................................................................................................................................ 10
Outside the USA ........................................................................................................................ 10
Ground Continuity Tests ............................................................................................................ 11
Environmental Requirements ........................................................................................................... 11
Space Requirements .................................................................................................................... 11
Humidity ....................................................................................................................................... 12
Air Quality .....................................................................................................................................12
Ambient Temperature................................................................................................................... 12
Relocation .................................................................................................................................... 12
Mobile Use ................................................................................................................................... 12
Transportation and Storage ......................................................................................................... 12
Section 2: Hazards, Precautions and Safety Features 13

Laser Room Precautions .................................................................................................................. 13
Flash Fire Hazards ........................................................................................................................... 13
Optical Precautions .......................................................................................................................... 14
Laser Eye Hazards and Safety Eyewear ..................................................................................... 14
Nominal Ocular Hazard Distance (NOHD) ................................................................................... 14
Optical Safety Precautions ........................................................................................................... 16
Electrical and Mechanical Hazards .................................................................................................. 16
High Voltage Electrical Hazard .................................................................................................... 16
Fiber-Optics .................................................................................................................................. 17
Laser Mobility Care and Wheel Locks.......................................................................................... 17
Chemical Hazards ............................................................................................................................ 17
Laser Dye Solution and Triplet Quencher .................................................................................... 17
Cryogen ........................................................................................................................................ 18
Guidelines for Cryogen Treatment Areas .................................................................................. 18
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03-FEB-20General Treatment Area Guidelines ..........................................................................................18
Frostbite Risks ........................................................................................................................... 19
Fire Hazards ..................................................................................................................................... 19
Treatment Area ............................................................................................................................ 19
Anesthetics ................................................................................................................................... 19
Instruments ................................................................................................................................... 19
Laser Fiber Fire Hazard ............................................................................................................... 19
Laser Generated Air Contaminants (LGAC) .................................................................................... 20
Laser Plumes ............................................................................................................................... 20
NIOSH Hazard Controls ............................................................................................................... 20
Electromagnetic Interference ........................................................................................................... 20
Safety Features ................................................................................................................................ 24
Password Protection .................................................................................................................... 24
Laser Emergency Stop Switch ..................................................................................................... 24
Screen Lock Button ...................................................................................................................... 24
PFN (Pulse Forming Network) Beep Sound Alert ........................................................................ 24
Lasing Beep Sound Alert ............................................................................................................. 24
STANDBY and READY Operating Modes ................................................................................... 24
Remote Interlock .......................................................................................................................... 25
Environmental Protection: Disposal Hazards and Guidance ........................................................... 26
Used Delivery System Accessories ............................................................................................. 26
Laser System Components and Accessories .............................................................................. 26
Hazardous Material and Hazardous Waste ................................................................................. 26
Section 3: Operating Instructions 27

Touch-Screen Display Monitor ......................................................................................................... 27
Laser Stop Switch ........................................................................................................................ 28
Delivery System Handpiece Connection Ports ............................................................................ 28
Verification Port ............................................................................................................................ 28
Verification Port Procedure Steps and Screens: ....................................................................... 29
Touch-Screen Display Panel ........................................................................................................ 31
Screen Lock Button ...................................................................................................................... 32
System Startup and Treatment Preparation ................................................................................ 32
Login to the Vbeam Prima Operating System ........................................................................... 32
Overview of the Treatment Screen ............................................................................................ 34
Treatment Screen Elements ...................................................................................................... 35
Start Up Verification Process ................................................................................................. 35
Treatment Pulse Counter Display/Reset Button .................................................................... 35
Trigger Source Selection Display ........................................................................................... 35
STANDBY Mode .................................................................................................................... 35
READY Mode ......................................................................................................................... 35
DCD Spray Settings ................................................................................................................... 36
Operating Parameters ................................................................................................................ 37
Laser Fluence (J/cm2) Settings .............................................................................................. 37
Pulse Duration ........................................................................................................................ 39
Pulse Repetition Rate............................................................................................................. 39
Spot Size Identification (Tip Type) ......................................................................................... 39
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03-FEB-20Treatment Application Options ..................................................................................................40
Guided Mode ................................................................................................................................ 41
End Treatment .............................................................................................................................. 44
System Settings ........................................................................................................................... 45
Device Tab ................................................................................................................................. 45
Trigger Source ........................................................................................................................ 45
Dial Appearance ..................................................................................................................... 45
Aiming Beam Intensity Setting ............................................................................................... 45
Language Tab ............................................................................................................................ 46
User Interface Language Selection ........................................................................................ 46
User Interface Convention Formats ....................................................................................... 46
Save Button ............................................................................................................................ 46
Clock Tab ................................................................................................................................... 47
System Date and Time Settings ............................................................................................. 47
Date and Time Format Settings ............................................................................................. 47
Save Button ............................................................................................................................ 47
Your Account Tab ...................................................................................................................... 48
Startup Policy Tab ...................................................................................................................... 50
Accounts Tab ............................................................................................................................. 51
Network Tab ............................................................................................................................... 52
Other System Functions and displays.......................................................................................... 53
System Lock Function................................................................................................................ 53
Log Out Function ....................................................................................................................... 53
Status Displays .......................................................................................................................... 54
Save LVM (Laser Variable Mode) Button .................................................................................. 57
Purge Button ................................................................................................................................ 58
Other Controls .................................................................................................................................. 58
Remote (CDRH) Interlock ............................................................................................................ 58
Footswitch Connector................................................................................................................... 58
Section 4: Clinical Guide 59

Indications for Use ............................................................................................................................ 59
595 nm ......................................................................................................................................... 59
1,064 nm ...................................................................................................................................... 59
Contraindications and Precautions................................................................................................... 59
Possible Adverse Effects .................................................................................................................. 60
Warnings and Precautions Concerning the Use of Cryogen (DCD Cooling) ................................... 60
Additional Warnings and Precautions .............................................................................................. 61
Section 5: Laser System Start-Up 62

Laser System Start-Up Procedure ................................................................................................... 62
Section 6: Maintenance, Troubleshooting and Delivery System Verification Tests 66

Laser Software and System Upgrades............................................................................................. 67
Laser System Software Upgrade USB Port and USB Flash Drive ..............................................67
Laser System Upgrades ............................................................................................................... 67
Fiber-Optic Delivery System ............................................................................................................. 68
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Windows and Lens ........................................................................................................................... 69
Cleaning and Disinfection ................................................................................................................. 71
The Laser System ........................................................................................................................ 71
The Delivery System Handpiece .................................................................................................. 71
To clean and disinfect the handpiece: ....................................................................................... 71
Distance Gauges .......................................................................................................................... 73
The Distance Gauges ................................................................................................................ 74
To Clean/Disinfect the housing shell and mask: .................................................................... 74
Delivery System Replacement ......................................................................................................... 76
GentleCool Pro Cryogen Canister .................................................................................................... 80
Cryogen Canister Replacement ................................................................................................... 80
Cryogen Leak ............................................................................................................................... 81
Canister Disposal ......................................................................................................................... 81
Laser Dye Solution Cartridge ........................................................................................................... 82
Water Cooling System ...................................................................................................................... 83
Display Monitor ................................................................................................................................. 83
Display Monitor Care and Cleaning ............................................................................................. 83
User Verification Tests ..................................................................................................................... 84
Overview of Tests ......................................................................................................................... 84
Test 1: Cryogen Alignment .......................................................................................................... 85
Test 2: Cryogen Coverage .......................................................................................................... 87
Test 3: Cryogen Bubble Detection .............................................................................................. 88
Test 4: Beam Alignment .............................................................................................................. 88
Warnings Related to the Delivery System ........................................................................................ 89
Treatment Related Warnings ........................................................................................................... 90
Troubleshooting ................................................................................................................................ 91
General Laser System Troubleshooting Solutions ....................................................................... 91
Fault and Warning Messages ........................................................................................................... 93
Troubleshooting Solutions for Fault and Warning Messages ......................................................93
Section 7: Labels and Symbols 100
Section 8: Laser Accessories and Replacement Parts 104

Vbeam Prima Laser System Accessories and Part Numbers ...................................................104
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Section 1: The Vbeam Prima Laser System
Applications
This operator’s manual provides operation instructions for the Vbeam Prima laser system with all
available configurations. The features included in your laser system depends on which options were
purchased. The following table lists all available configurations for the Vbeam Prima laser system.
Table 1: Vbeam Prima Laser System Configurations
Laser System P/N # Configuration

9914-00-9080 Full Configuration
9914-00-9081 Basic Configuration
Vbeam Prima
9914-00-9082 EverCool Configuration
9914-00-9084 Nd:YAG Configuration
The Vbeam family of lasers deliver pulses of laser energy at a wavelength of 595 nanometers (nm)
and optional Nd:YAG laser energy at a wavelength of 1064 nm (Vbeam Prima only). Note that the
1064 nm wavelength is similar in design, indications, and specifications as the Gentle Family
manufactured by Candela. Both laser wavelengths pass through the dermis and epidermis of the skin
layers where the 595 nm wavelength is selectively absorbed by the hemoglobin in the blood vessels
rather than by the surrounding tissue.
The 1064-nm wavelength is most highly absorbed in melanin, less absorbed in hemoglobin, and
slightly absorbed in water. For both wavelengths the absorbed laser energy is converted into heat,
causing coagulation of the target vessels or destruction of melanin, which are not subsequently
regenerated. The pulse duration, which is selectable, can be long enough to produce controlled
coagulation but short enough to avoid thermal damage to the surrounding tissue.
This process of targeting a specific chromophore (hemoglobin) is called selective photothermolysis.
Ideally, the wavelength selected for eradiation of vascular lesions is highly absorbed by the lesion and
only minimally absorbed by other competing chromophores in the skin. The laser pulse duration
should be shorter than the thermal relaxation time of the target absorbing the laser radiation to
confine the thermal damage and spare surrounding tissue. The relaxation time of a target is
determined by size (milliseconds or greater for vascular lesions).
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03-FEB-20
System Description
Laser System
The Vbeam Prima Laser System uses a dye solution as its lasing medium, which is excited by a high
intensity xenon flashlamp as it continuously circulates through the laser head. After many exposures
to the flashlamp energy, the dye becomes degraded and the dye cartridge must be replaced. The
Vbeam Prima laser also includes the unique MegaDye Cartridge that enables the system to deliver
many thousands of pulses before requiring dye replacement.
Figure 1: Vbeam Prima – Front View

The laser head is cooled by the circulation of deionized (DI) water, which in turn is cooled by ambient
air passing through a heat exchanger. A combination of heaters and heat exchangers maintain the
temperatures of various system components within the optimum range for efficient laser operation. A
handpiece verification port is located in the top-right corner of the system’s front panel. This port is
used to verify output calibration of the laser through the handpiece at selected fluence levels.
To provide energy to the flashlamp, a high-voltage power supply charges a storage capacitor. Then
the high voltage switch transfers a portion of the energy from the storage capacitor into the flashlamp.
The resulting flash excites the dye solution causing the emission of a pulse of laser energy.
The output of the laser is delivered through an optical fiber coupled to a handpiece. The handpiece
contains the internal focal lenses and a protruding tip. The tip is placed against the skin to ensure

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proper focusing and spot placement on the treatment area. A trigger-switch (finger-switch or foot-
switch) controls the delivery of the pulses.
The user selects the desired energy density (fluence) level and enables or disables the laser at the
display monitor. The laser delivers pulses at a repetition rate of up to:
● 1.5 Hz for the 595-nm wavelength
● 10 Hz for the 1064-nm wavelength
The laser system is equipped with interlocks that will disable the 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 transitions to READY mode.
Figure 2: Vbeam Prima – Rear View

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Dynamic Cooling Device (DCDTM)
The laser system comes with a skin cooling device referred to as the Dynamic Cooling Device (DCD).
This device is located inside the DCD and Storage Compartment of the laser (see Figure 1). The
DCD consists of an electrically controlled spray nozzle located at the treatment end of the handpiece,
a cryogen 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 a
burst of cryogen spray to be applied to the skin prior to the laser pulse. Controls are provided on the
laser front panel for the adjustment of the spray burst duration and for the time delay between the
spray burst and the laser pulse. Refer to the GentleCool Pro Cryogen Canister section of this manual
for cryogen canister installation, warm-up, removal and disposal instructions.
DCD Delivery System Handpiece

Each laser configuration comes with its own Delivery System and Distance Gauge. The Vbeam Prima
includes a delivery system and distance gauges.
Your system will have been delivered with the DCD delivery system, the EverCool delivery system, or
both, depending on the purchase agreement with Candela.
The cable harness contains the fiber-optic cable, cryogen input line and valve control wires. The
handpiece assembly contains the DCD spray nozzle, the trigger switch (fingerswitch) and the safety
and detection electronics. The laser aperture is located at the distal end of the handpiece where the
distance gauge is inserted. The spray nozzle is located near the distance gauge at the treatment end
of the handpiece. The fingerswitch is located on the top of the handpiece.
The handpiece also has a READY/STANDBY switch, illuminated when laser is in READY mode.
Cable
Assembly
Fingerswitch
The Delivery
System
Connectors: Laser Aperture,
Cryogen Spray and
Fiber Optic, Distance Gauge
Cryogen Line, Location
and Valve
Control
Connectors Handpiece
Figure 3: DCD Handpiece Delivery System Assembly

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EverCool Delivery System Handpiece
The Vbeam Prima laser system also provides additional protection to the surface of the skin from
unwanted thermal injury via the EverCool contact cooling handpiece.
The EverCool handpiece does not use the replaceable distance gauges.
Cable
Assembly
Finger
Switch
Laser
Aperture and
Fixed-
Distance Tip
Figure 4: EverCool Delivery System Handpiece
Tips and Distance Gauges

The Vbeam Prima Delivery System and Distance Gauge Kit includes four Ultem® distance gauges
called Smart Gauges. The distance gauge assembly contains internal focusing lenses and
input/output windows to protect the lenses from dust and debris.
Removal and cleaning of the windows is explained in the Windows and Lens section of this manual.
DCD Delivery System Smart Gauges

The Smart Gauges are available in 3-7, 7-11, 11-15, 3x10 and 1.5 mm spot sizes.
Locking/Swivel Wheels
The Vbeam Prima laser system is equipped with four wheels that can swivel, making for easy parking
in tight spaces.
The swivel wheels contain levers which stop the wheels from rotating. To prevent the laser from
moving the wheels must be locked. To lock the wheels, press the locking lever on the wheels. To
release pull up on the lever.

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Fiber Support Pole
The fiber support pole supports the delivery system cable harness as shown in Figure 5. This device
will keep the cable harness suspended and reduce the weight of the delivery system during use.
The fiber support pole is adjustable, may be rotated 180° horizontally and can be removed from the
laser system without the use of tools.
Figure 5: Fiber Support Pole Assembly
Caution!
To reduce the risk of personal injury and damage to the delivery system fiber, use the fiber
support pole to support the delivery system at all times. When not in use, insert the handpiece
in the handpiece holster. This removes excess fiber slack from the delivery system and the
possibility of damage to property and/or personal injury from stepping on, tripping and/or
running wheels over the fiber.
Caution!
When using the fiber support pole to support the delivery system, make sure there are no sharp
bends in the delivery system. The Vbeam Prima laser system incorporates 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 will be damaged.

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System Specifications
Vbeam Prima Laser System Specifications

Table 2: Specifications for the Vbeam Laser System
Parameter Specified Value

● Flashlamp-excited, pulsed dye laser energy
Therapeutic Energy Output:
● Flashlamp-excited, Nd:YAG laser energy
● Pulse-dye Laser: 595 nm
Laser Wavelengths:
● Nd:YAG Laser: 1,064 nm
● Pulse-dye Laser: Minimum OD 5.0 @ 592-596 nm
Safety Eyewear:
● Nd:YAG Laser: Minimum OD 5.0 @ 1062-1066 nm
● Green LED
Aiming Device:
● 520 - 550 nm, <3.0 mW max.
● Pulse-dye Laser: Up to 1.5 Hz
Laser Pulse Repetition Rate:
● Nd:YAG Laser: Up to 10 Hz
● Pulse-dye Laser: 0.45 – 40 ms
Laser Pulse Duration:
● Nd:YAG Laser: 0.5 – 60 ms
● Pulse-dye Laser: 12 J
Maximum Pulse Energy:
● Nd:YAG Laser: 45 J
● Length: 98.5” / 2.5 meters
Fiber Delivery Systems ● Minimum bend radius: 6.0” / 15 cm

(595, 1064nm): ● Recommended storage radius: 9.0” / 23 cm
● Fiber transmission attenuation: 90%
Method of Optical Output: Lens-coupled optical fiber with user-selectable spot sizes
Accuracy of Output Energy: ± 20%
DCD EverCool
● 3–15 mm Zoom
Beam Spot Sizes:
● 3 x 10 mm 3–15 mm Zoom
● 1.5 mm
Cooling Method: Ambient air
Networking method: Wi-Fi
Dimensions (H x W x D): 53 x 20 x 33 inches / 135 x 51 x 84 cm
Weight: 280 lbs. / 127 kg.

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Parameter Specified Value
● Ambient temperature: 65-85°F / 18-29°C
Environmental Requirements: ● Relative humidity: 20-80%, non-condensing
● Storage temperature: 40-110°F / 4.5-43°C
Cryogen: Dymel® 134a/P (Halocarbon), containers of 1.0 kg.
Electrical Requirements: 200-240 VAC~ ; 4600 VA ; 50/60 Hz ; single phase
● ON / OFF: Momentary push-button and footswitch
Laser Pulse Controls: ● Emergency OFF: Red push-button with lock
● Lasing: Audible beep indicator per pulse

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Medical Electrical Equipment Standard Specifications and Classification
Electromagnetic Compatibility (EMC)
Table 3: Compliance per IEC / EN60601-1
Type of protection against electric shock Class I equipment

Degree of protection against electric shock offered by
Type “B”
the applied part
Sterilization method None Required
Ingress Protection Ordinary enclosed
Not “AP” or “APG” equipment
Regulatory Classifications
The laser is a Class 4 laser product with Class 1 aiming beam per EN60825-1 Laser Hazard
Classification.
Candela Family of Pulsed Dye Lasers complies with 21 CFR 1040.10 and 1040.11 except for
deviations pursuant to Laser Notice No. 50, dated July 26, 2001
Candela Family of Pulsed Dye Lasers should be installed and operated according to CAN/CSA-Z386-
92: Laser safety in health care facilities.
Electrical Requirements
The Electrical Requirements for the Vbeam Prima Laser System are listed in Table 1.4.
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 laser is shipped with a 12-foot (3.7 meter) power cable 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 1.4 for electrical service requirements.
For International installations, the power connections should be made with a grounded 2-conductor
plug and receptacle pair. The plug and receptacle must be rated for the service line voltage at a
minimum and capable of handling 4,600 VA (See Table 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.

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Installation Site Electrical Service Requirements
USA
200–240V~, 4600 VA, 60 Hz, center-tapped, single phase, dedicated branch circuit with earth ground
conductor. A dedicated 30 A circuit breaker is required on site.
Outside the USA
200–240V~, 4600 VA, 50/60 Hz, single phase, dedicated branch circuit with earth ground conductor.
A dedicated circuit breaker with current rating compliant with the local code requirements.
Operation of the Vbeam Prima Laser System on a power line that is not consistently within
these specifications may damage the system and will void the service warranty agreement.
Note
The system may be isolated from AC mains by unplugging the power cable from the electrical
service.
Figure 6: Service Panel

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03-FEB-20
Ground Continuity Tests
The laser system requires a connection to earth ground to reduce the risk of electric shock. To verify
that this safety feature is functioning properly, it is recommended 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
unsure of which pin is “ground” on your 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 and light, or a battery and buzzer combination maybe be alternatively used to verify
a ground connection between any unpainted conductive surface and the plug’s ground pin if
an Ohm meter is not available. An adequate ground connection will be indicated by the
illumination of the light or sounding of the buzzer.
Environmental Requirements
Before the installation of the Vbeam Prima Laser System, the intended site must be prepared as
described in this section. The site must have sufficient space to accommodate the laser system, must
provide the proper electrical power configuration and receptacles, and must meet the additional
environmental specifications.
Important Note
Installation of the laser 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 Vbeam Prima Pulsed Dye Laser System.
Reference document: Vbeam Prima Service Manual (P/N # 8501-00-9075).
Important 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 Material Safety Data Sheet
or MSDS sheet (Candela P/N 8501-00-1701) for General Treatment Area Guidelines and further
information.
Space Requirements
Sufficient floor space is required for the laser system. Approximately 15 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 from the cooling vents.

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Humidity
Humidity of 20% to 80% (non-condensing) should be maintained in the laser room.
Air Quality
Ensure that the atmosphere is non-corrosive with no salts or acids in suspension 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.
Ambient Temperature
A temperature between 65° and 85°F (18° and 29°C) should be maintained in the laser room during
operation. The laser system must be stored at a temperature between 40° and 110°F (5° and 43°C).
Avoid placing the laser system near heating outlets or other sources of air currents that could cause
uneven cooling in the laser system.
Relocation
Care should always be taken when moving the Vbeam Prima laser system. Before moving the laser,
disconnect the footswitch tubing from the connector located on the rear panel of the laser and the
delivery system from its connection port (place the delivery system into its original box for
transportation if necessary). A wrap-around handle with hand-held sections on the front and rear
panels allows easy movement of the system, but 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 laser, contact Candela Technical Support or your distributor
for details. Failure to do so may result in personal injuries or damage to the system and may void any
warranty.
Mobile Use
The Vbeam Prima laser system is not designed for mobile use.
Transportation and Storage

For transport and storage of the Vbeam Prima Laser system, the temperature must be kept between
40 to 110°F (5 to 43°C) and humidity between 20 to 80% (non-condensing). Ambient atmospheric
pressure is suitable with no restrictions.
Warning!
DO NOT EXPOSE TO TEMPERATURES BELOW 5°C (40°F) OR DAMAGE MAY OCCUR.
CONTACT CANDELA TECHNICAL SUPPORT PRIOR TO USE.

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Section 2: Hazards, Precautions and Safety Features
Laser Room Precautions

● Identify the laser room clearly. Post appropriate warning signs in prominent locations at all
entrances to the laser room.
● Cover all windows, portholes, etc. with opaque material to prevent unintended viewing or laser
light escaping from the laser room.
● When the Vbeam Prima Laser System is in operation, restrict entry and limit access to the laser
room only to personnel that are both essential to the procedure and well trained in laser safety
precautions.
● 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.
Flash Fire Hazards

Hair, gauze, masks, cannula and airway materials can be ignited by laser energy in an oxygen-
enriched atmosphere even if thoroughly soaked with saline. The following scenario can lead to a flash
fire during laser treatment:
● 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.
● An oxygen-rich atmosphere is created and dissipates over the face. Transient local
concentrations of oxygen can greatly accelerate combustion.
● During treatment, the laser beam strikes combustible material which absorbs the laser energy
and heats the material above is combustion point. This may occur simply by singeing the tip of a
single dry hair.
● This momentary and possible 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.
● 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.

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03-FEB-20
Caution!
THE ELECTRICAL AND LASER RADIATION HAZARDS PRESENT DURING SERVICING OF THE
VBEAM LASER SYSTEM CAN BE EXTREMELY DANGEROUS AND SHOULD BE SERVICED
ONLY BY THOSE QUALIFIED TECHNICIANS WHO HAVE RECEIVED APPROPRIATE TRAINING
ON THE VBEAM LASER SYSTEM FROM CANDELA.
Optical Precautions
Laser Eye Hazards and Safety Eyewear
Caution!
USE ONLY SAFETY EYEWEAR WITH AN OPTICAL DENSITY OF ≥ 5.0 BETWEEN 592 AND 596
NANOMETERS (NM).
The laser beam emitted by the Vbeam Prima Laser System can cause loss of vision. The laser
operates at these wavelengths:
• 595 nm, within the visible spectrum
• 1064 nm, outside the visible spectrum.
The cornea and lens of the eye are transparent to visible light. Any energy emitted by the Vbeam
Prima 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.
Nominal Ocular Hazard Distance (NOHD)

The laser aperture of the Vbeam Prima Laser System 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 full angle beam divergence for each handpiece is shown in Table 2.1.
To avoid vision hazards, everyone within the NOHD of the Vbeam Prima Laser System must wear
appropriate eye protection available from Candela, as detailed in Table 4 on the following page.

Laser System
Table 4: Vbeam Prima Laser System Vision Hazards and NOHD Zone
03-FEB-20
Spot Diameter Max. Fluences [J/cm2] NOHD [Meters]
Attenuation Factor for 100 mm Distance
[m] Dye Nd:YAG Dye Nd:YAG
1.5 N/A 400 0 4.94 0.001505424
3 40 400 24.74 71.93 0.18595041
3.5 38 300 32.17 83.10 0.035408718
4 35.5 250 41.49 101.21 0.069252078
4.5 33 220 49.47 117.43 0.099026847
5 30 210 58.19 141.55 0.139229227
5.5 28 175 67.17 154.37 0.176271779
6 27 150 78.73 170.60 0.219726563
6.5 25.5 130 89.17 185.09 0.253890992
7 24 110 100.79 198.38 0.289940828
7.5 22.5 100 111.78 216.64 0.36
8 22 50 126.64 175.51 0.44444444
8.5 20.5 50 138.00 198.14 0.631059481
9 19 50 150.05 223.78 0.916704391
9.5 17 50 157.81 248.82 0.840867757
10 15 50 164.84 276.68 0.780381825
10.5 13.5 50 172.38 305.00 0.745609526
11 12.5 50 182.89 336.28 0.715976331
11.5 11.5 25 191.56 259.66 0.684488381
12 10 25 195.08 283.58 0.657414171
12.5 9.5 25 206.58 308.09 0.625901298
13 9 25 218.51 334.81 0.598781179
13.5 8.5 25 229.95 362.56 0.581729388
14 8 25 241.69 392.79 0.566539484
14.5 7.25 25 248.33 423.95 0.550101059
15 6.75 25 258.78 457.86 0.535395598
3X10 25 130 81.16 211.04 0.258264463

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03-FEB-20
Caution!
THE LASER BEAM EMITTED BY THE VBEAM LASER SYSTEM SHOULD NEVER BE DIRECTED
AT ANY PART OF THE BODY OTHER THAN THE INTENDED SITE OF TREATMENT OR TESTING.
Optical Safety Precautions

Follow these precautions to ensure optical safety:
● Appoint one person responsible for the laser system controls during the procedure.
● Ensure that all personnel wear appropriate safety eyewear whenever the laser system is ON.
● Never look directly into the laser beam even when wearing protective eyewear.
● Never allow the laser beam to be directed at anything other than the targeted area or the
calibration port.
● Never permit reflective objects such as jewelry, instruments or mirrors to intercept the laser
beam.
● When the Vbeam Prima Laser System is not in use, set it to STANDBY mode to prevent
accidental pulsing.
● When the Vbeam Prima Laser System is unattended use the password protected screen lock
button on the display panel to prevent unauthorized use.
Electrical and Mechanical Hazards
High Voltage Electrical Hazard

The Vbeam Prima Laser System converts and amplifies the AC line voltage to produce 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 OFF and even after the Vbeam Prima Laser
System has been disconnected from the line voltage. Therefore, no part of the exterior housing
should be removed except by a trained and authorized technician.
Warning!
TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A
SUPPLY MAINS WITH PROTECTIVE EARTH.

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03-FEB-20
Fiber-Optics
The Vbeam Prima Laser System 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 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. When damaged, the fiber or delivery
system becomes a potential fire hazard (See Fire Hazards).
Laser Mobility Care and Wheel Locks

To prevent the laser from moving, all four 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 tabs.
Although the Vbeam Prima Laser System is well balanced, it weighs 280 pounds (127 kg.) and may
cause injury if proper care is not used when moving it. The system should always be moved carefully
and slowly.
Chemical Hazards
Laser Dye Solution and Triplet Quencher
The dye solution circulating through the system and contained within the filter housing should be
treated as toxic. The system also utilizes a triplet quencher contained in a clear glass jar which should
be treated as toxic. Read MSDS Candela P/N 7121-90-9940 for more complete information.
The MegaDye Cartridge is replaced by an authorized Candela Service Representative. The triplet
quencher is not accessible by the customer and must be changed by a Candela authorized service
representative.
Use of dye or solvents not supplied by Candela voids all warranties. Candela takes no responsibility
for any equipment failure, material damage, or personal injury resulting from such misuse.
In case of an accident, take the following measures:
● Ingestion: If the dye solution is ingested, drink 2 – 4 glasses of water, induce vomiting and
call a physician.
● Inhalation: If the vapors of the dye solution are inhaled, move to fresh air. If symptoms are
present, treat symptomatically and get medical attention.
● Eye Contact: If the dye solution gets into the eyes, immediately flush the eyes with water for
at least 15 minutes and get medical attention if symptoms are present.
● Skin Contact: If the dye solution comes in contact with the skin, flush immediately with
water and wash thoroughly with soap and water. Any dye residue (stain) remaining on the
skin will disappear in time.

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03-FEB-20
Cryogen
The laser system uses a Hydrofluorocarbon (HFC) or cryogen in the Dynamic Cooling Device (DCD).
● 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.
Important Note to Physicians

Because of possible disturbance 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, Candela P/N 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 parts per
million (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./3.75 sq. m (5 x 8-ft./1.5 x 2.45-m) – based
on an 8-ft/2.45-m. ceiling.
● Any treatment area smaller than 513 sq. ft./4.6 sq. m (but larger than 40 sq. ft./ 3.75 sq. m)
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 possible, have the exhaust fan lower 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 possible, one ventilation opening should be to outdoors. Both opening sizes
should be approximately the same area.
● Refer to MSDS sheet (Candela Part Number 8501-00-1701) for further information.

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03-FEB-20
Frostbite Risks
Treatment areas should have sufficient free floor space to allow a patient or user the ability to move
away from unanticipated spray of cryogen. The following table gives some exposure guidelines:
Table 5: Frostbite Prevention in Treatment Areas
Hand detection of outer edge
Source of Cryogen Release Visual outer edge of spray
of spray
Direct release from cryogen
27 inches 31 inches
canister
Release from tip of handpiece
19 inches 23 inches
(spray nozzle)
For specific customer situations, contact Candela Technical Support.
Fire Hazards
Refer to the American National Standard for Safe Use of Lasers ANSI Z136.3-2005 Section 7.
Treatment Area
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

Vbeam Prima 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 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.

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03-FEB-20
Laser Generated Air Contaminants (LGAC)
Laser Plumes
Laser Plume may contain viable tissue particulate.
Please reference the American National Standard for Safe Use of Lasers (ANSI A136.3. -2005),
Section 7.3 Laser Generated Air 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.
NIOSH Hazard Controls

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).
Electromagnetic Interference
The Vbeam Prima system is designed to have no degradation in performance or cause interference
in the operation of other equipment when used in the EMC environment described in the following
tables. Refer to the guidance in these tables for additional information. In the rare case that an
undesirable EMC event occurs, the Vbeam Prima system is designed to revert to Standby mode.
Caution!
The Vbeam Prima system should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the equipment should be observed to verify normal
operation in the configuration in which it will be used.
The Vbeam Prima laser system was designed to comply with IEC/EN 60601-1-2 (Group 1, Class A)
"Electromagnetic Compatibility Requirements and Tests”. Class A equipment is intended for use in
commercial and industrial locations. A portion of IEC/EN 60601-1-2 deals with measurements of
unwanted radio frequency emissions 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 Vbeam Prima laser system have been reduced as
far as practical without compromising functionality.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the tables below.

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03-FEB-20
Table 6: Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems
The Vbeam Prima system is intended for use in the electromagnetic environment specified below.
The customer or user of the Vbeam Prima system should ensure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
The Vbeam Prima system uses RF energy only for its
RF Emissions CISPR internal function. Therefore, its RF emissions are very low
Group 1
11 and are not likely to cause any interference in nearby
electronic equipment.
RF Emissions CISPR
Class A The Vbeam Prima system is suitable for use in all
11
establishments, other than domestic, and those directly
Harmonics IEC
N/A connected to the public low- voltage power supply network
61000-3-2
that supplies buildings used for domestic purposes.
Flicker IEC 61000-3-3 N/A
Table 7: Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems
environment.
Immunity Test EN/IEC 60601 Compliance Electromagnetic Environment –
Test Level Level Guidance
ESD ±8kV Contact ±8kV Contact Floors should be wood, concrete or
EN/IEC 61000-4-2 ±15kV Air ±15kV Air ceramic tile. If floors are synthetic, the
r/h should be at least 30%.
EFT ±2kV Mains ±2kV Mains Mains power quality should be that of
EN/IEC 61000-4-4 ±1kV I/Os ±1kV I/Os a typical commercial or hospital
environment.
Surge ±1kV ±1kV Mains power quality should be that of
EN/IEC 61000-4-5 Differential Differential a typical commercial or hospital
±2kV Common ±2kV Common environment.
Voltage Dips/ 100% Drop for 100% Drop for Mains power quality should be that of
Dropout EN/IEC 0.5 Cycle, 45 0.5 Cycle, 45 a typical commercial or hospital
61000-4-11 deg increments deg increments environment. If the user of the Vbeam
Prima system requires continued
100% Dip for 1 100% Dip for 1 operation during power mains
Cycles Cycles interruptions, it is recommended that
the Vbeam Prima system be powered
30% Dip for 25 30% Dip for from an uninterruptible power supply
Cycles 25 Cycles or battery.
100% Drop for

100% Drop for 5
5 Seconds
Seconds
Power Frequency 30 A/m 30 A/m Power frequency magnetic fields
50/60Hz should be that of a typical commercial
Magnetic Field or hospital environment.
EN/IEC 61000-4-8

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03-FEB-20
Table 8: Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems that
are NOT Life-supporting
environment.
Immunity Test EN/IEC 60601-4-4 Compliance Electromagnetic Environment –
Test Level Level Guidance
Portable and mobile communications

equipment should be separated from
the Vbeam Prima system by no less
than the distances calculated/listed
below:
D=(3.5/V1)(Sqrt P)
D=(3.5/E1)(Sqrt P)
Conducted RF 3 Vrms 3 Vrms
80 to 800 MHz
EN/IEC 61000-4-6 6Vrms ISM, 6Vrms ISM,
D=(7/E1)(Sqrt P)
150 kHz to 80 MHz 150 kHz to 80
MHz 800 MHz to 2.7 GHz
3 V/m Where P is the max power in watts

Radiated RF 3 V/m
80 MHz to 2.7 and D is the recommended separation
EN/IEC 61000-4-3 80 MHz to 2.7 GHz distance in meters.
GHz
Field strengths from fixed transmitters,

as determined by an electromagnetic
site survey, should be less than the
compliance levels (V1 and E1).
Interference may occur in the vicinity

of equipment containing a transmitter.

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03-FEB-20
Table 9: Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and the Vbeam Prima System Equipment and Systems that are
NOT Life-supporting
Recommended Separations Distances for the Vbeam Prima system

The Vbeam Prima system is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the Vbeam Prima system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
Communications Equipment and the Vbeam Prima system as recommended below, according to
the maximum output power of the communications equipment.
Max Output Power Separation (m) Separation (m) Separation (m)
(Watts) 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.7GHz
D=(3.5/V1)(Sqrt P) D=(3.5/E1)(Sqrt P) D=(7/E1)(Sqrt P)
0.01 0.1166 0.1166 0.2333
0.1 0.3689 0.3689 0.7378
1 1.1666 1.1666 2.3333
10 3.6893 3.6893 7.3786
100 11.6666 11.6666 23.3333
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
If interference from the Vbeam Prima 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
Vbeam Prima laser system or the affected equipment into another room.
Warning!
The Vbeam Prima laser system should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the equipment should be observed to
verify normal operation in the configuration in which it will be used.
Warning!
When treating patients with this laser 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.
Warning!
Care must be taken with patients who have an implanted pacemaker. Pacemaker operation may
be affected by an electrical “plasma effect” when treating near or at the site of the implant.

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03-FEB-20
Safety Features
Password Protection
To prevent unauthorized use, the system access is protected by a password that is entered via the
touch-screen display monitor. To prevent degraded performance and/or patient injury, it is important
to make sure that only authorized users have access to the system.
Laser Emergency Stop Switch

STOP When the red switch with this label underneath (located adjacent to the display monitor, see Figure 1)
is pressed, the Vbeam Prima laser is shut down immediately.
Screen Lock Button

When the screen lock button is pressed, it will query you about locking the screen (see Section 3). If
you select Yes by pressing the button with the checkmark, the system will transition to STANDBY
mode, all screen buttons will be locked except for the screen lock button. A Candela logo screen with a
padlock and key button will be displayed indicating the display is locked. When the screen is already
locked, and the screen lock button is pressed, a keypad will be displayed to enter in a 4-digit code
(code is “5277”). This code will be the same for all lasers and provided in the user's manual.
PFN (Pulse Forming Network) Beep Sound Alert

An audible beep will be heard when the Pulse Forming Network (PFN) is fully charged and the laser
is ready to deliver a pulse of energy.
Lasing Beep Sound Alert

An audible beep will be heard, and the READY indicator will change to a lasing symbol to indicate
that the laser is releasing laser energy.
STANDBY and READY Operating Modes

The system operates in one of two modes: STANDBY and READY. In STANDBY mode, laser
emission is disabled. The operator must set the system to READY mode to enable laser emission. In
READY mode, laser pulses are generated by pressing the trigger switch. As a safety precaution,
there is a delay of two seconds from the time that the system enters READY mode to the time that
the laser emission is enabled. When the laser system is not being used, it should be returned to
STANDBY mode. The laser will automatically revert to STANDBY mode after two minutes of inactivity
in READY mode. The operator selects the operating mode via the display panel. System mode
information is also displayed on the display panel.

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03-FEB-20
Note
A Software Lock Button is included to prevent unauthorized use when not in room. The laser
will remain in warm-up mode when the software lock is engaged. The software lock is user-
initiated.
Remote Interlock
An external connector for a remote interlock switch is provided on the rear panel of the system (see
Figure 6). This interlock switch can be connected to the doors of the laser room. If the door is opened
and the Vbeam Prima laser is ON and operating, laser energy emission will immediately be stopped.
To proceed with the procedure, ensure that the treatment room door is closed, set the system back to
READY mode and continue normally. For more information, on installation of a remote interlock,
please call Candela Technical Support.

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03-FEB-20
Environmental Protection: Disposal Hazards and Guidance
Used Delivery System Accessories
Residues that accumulate on the delivery system windows and distance gauge during 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. Therefore, at the end of its useful life, the
distance gauge, windows and 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 (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 servicing patient-contact
parts to reduce risk associated with exposure. The gloves should be disposed of in the same manner
as contact parts.
Laser System Components and Accessories
The Waste Electrical and Electronic Equipment (WEEE) Directive Label on the rear of the laser
system indicates that the Vbeam Prima Laser System and its components cannot be disposed of as
regular trash. Contact Candela for disposal instructions.
Hazardous Material and Hazardous Waste
Several components of the Vbeam Prima Laser System are classified as hazardous materials.
The internal dye fluid system maintains appropriate solution concentrations and circulates the solution
through the laser head. Within this fluid system, there are several items that are classified as
“hazardous”.
● Refer to the MSDS (Candela P/N 7121-90-9940) and the following matrix.
● Refer to the Cryogen MSDS Candela P/N 8501-00-1701 for further information on safety,
handling, first aid and disposal.
Table 10: Hazardous Materials
Item Hazardous Category Comments
Triplet Quencher and Must be disposed of as hazardous waste or

Flammable, Toxic
Laser Dye Solution shipped as hazardous material.
When replaced, it is considered a hazardous
material. Must be disposed of as hazardous
MegaDye Cartridge Flammable, Toxic waste or shipped as hazardous material because
of its Triplet Quencher and Laser Dye solution
content.
Must be disposed of as hazardous waste or
GentleCool cryogen shipped as hazardous material. A canister may
Pressure
canister be vented to empty and then be disposed of in
the trash as “non-hazardous” waste.
Warning!
PROPER DISPOSAL OF THE LASER SYSTEM, ITS COMPONENTS, ACCESSORIES AND
HAZARDOUS MATERIALS/WASTE SPECIFIED IN THIS MANUAL AND THE REFERENCED
DOCUMENTS IS REQUIRED. READ ALL LABELS, PROCEDURES AND THE REFERENCED
DOCUMENTS FOR ADDITIONAL INFORMATION.

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03-FEB-20
Section 3: Operating Instructions
Touch-Screen Display Monitor

The Vbeam Prima Laser System’s display monitor is located on top the system (see Figure 7). It
consists of an ON/OFF push-button, a laser stop (emergency OFF) push-button switch, READY
mode indicator, calibration port (on front panel), handpiece delivery system connection ports, and a
touch-screen display panel. The display panel provides a simple graphic user Interface (GUI) for the
operator. The operator uses this interface to select the laser operating parameters, DCD parameters
and output energy calibration.
B
D
Figure 7: Top Panel and Touch-Screen Display monitor
A Touch-screen display monitor

B Power switch push-button
C Emergency stop switch
D USB connection ports

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03-FEB-20
Laser Stop Switch
When the red laser emergency stop switch (see Figure 7) is pressed, the Vbeam Prima laser system
immediately shuts down. Turn the emergency stop switch counter-clockwise to reset it. If the
emergency stop switch is not reset the system will not be operational.
Delivery System Handpiece Connection Ports

The fiber-optic, cryogen line and DCD valve control receptacles are for connecting the handpiece
delivery system harness assembly to the laser (see Figure 8).
Figure 8: Delivery System Verification Ports
A Delivery System Coolant Connections

B Delivery System Power Connection
C Delivery System Fiber Connection
Verification Port
The Verification Port is used to verify the laser transmission through the fiber optic delivery system.
The handpiece must be inserted into the Verification Port to initiate this procedure. To perform the
Verification, the handpiece and the inserted distance gauge must be cleaned and dried before being
placed in the Verification Port.
The Verification Port, handpiece and distance gauge (including windows and lens) must be kept clean
at all times to maintain optimal laser performance.

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03-FEB-20
Verification Port Procedure Steps and Screens:
• When the handpiece is placed into the Verification Port while the Treatment screen is displayed,
the following window will appear:
Figure 9: Energy Verification – Step # 1
• The screen automatically clears if the handpiece is removed from the Verification Port, or you may
press the Close button.
• When pulsing into the Verification Port, one of four following results may be provided, depending
on the measurement.
 If the measurement was not valid for some reason, observe the following:
Figure 10: Energy Verification – Failure

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03-FEB-20
If verification was successful, observe the following:
Figure 11: Energy Verification – Successful
If the energy is too low, observe the following:
Figure 12: Energy Verification – Energy Too-Low Warning

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03-FEB-20
If the energy is too high, observe the following:
Figure 13: Energy Verification – Energy Too-High Warning
Touch-Screen Display Panel

The touch-screen display panel features a Smart User Interface, easily allowing the user to access
and monitor the laser system operation functions. Figure 14 shows the Treatment screen for 1064
nm. Choosing from the menus and submenus, the user can set and select desired parameters to
perform patient treatments.
Figure 14: Treatment Screen (Sample)

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03-FEB-20
Screen Lock Button
A password protected software Lock is included to prevent unauthorized use of the laser. The laser
will remain in warm-up mode when the software lock is engaged. The software lock will be initiated by
the user. Press the Options button in the top bar of the screen, shown on the left; the Options pop-
up will display (see Figure 15). Press the Lock button in the pop-up; it will query the user about
locking the screen. If Yes is selected and pressed, the system will transition to STANDBY mode, all
screen buttons will be locked except for the screen lock button. A Candela logo screen with a padlock
and a key button will be displayed indicating the display is locked.
Figure 15: Options Pop-Up

System Startup and Treatment Preparation
Login to the Vbeam Prima Operating System
Warning!
TO PREVENT UNAUTHORIZED USE, THE SYSTEM ACCESS IS PROTECTED BY A PASSWORD.
TO PREVENT DEGRADED PERFORMANCE AND/OR PATIENT INJURY, IT IS IMPORTANT TO
MAKE SURE THAT ONLY AUTHORIZED USERS HAVE ACCESS TO THE SYSTEM.
1. After turning the system ON, a splash screen will be displayed.

2. Touch the screen to close the splash screen and display the Login screen and the virtual
keypad.
Figure 16: Login Screens: User (Caregiver, on Left) and Owner (Administrator, on Right)

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03-FEB-20
3. Trace your finger on the virtual keypad in the shape of a "Z" to enter the password pattern
(see Figure 16); a popup appears with several important safety tips. Press the OK button to
advance to the Home screen.
Figure 17: Home Screen (for illustration purposes only)
Note
It is strongly recommended that the password pattern be changed periodically.
The password pattern may be replaced with a numerical password.

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03-FEB-20
Overview of the Treatment Screen
The touch-screen features a smart user interface, that allows the operator to access and monitor the
laser system operation functions. Figure 18 shows the Treatment screen.
Selecting from the buttons, menus and submenus, the operator sets the desired parameters to
perform patient treatments.
Figure 18: Treatment Screen Elements
A Content indicator of the dye cartridge

B Time duration of the active treatment session
C Pulse counter during the active treatment session
D Wavelength selection toggle switch (595 or 1,064 nm)
F Laser fluence setting (energy density)
E Pulse duration setting
G Pulse rate setting (pulses per second)
H Type of tip connected to the handpiece and spot diameter
I System lock, log out, settings and status drop-down menu
J Reset the pulse counter (between patients)
K Trigger source indicator (footswitch; fingerswitch)
L STANDBY / READY mode selector
M DCD cryogen canister status indicator (full-to-empty)
N DCD cryogen spray/delay duration selector toggle
P End Treatment button (transition to Home screen)
R DCD purge button

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Treatment Screen Elements
Start Up Verification Process
The startup verification process is automatically initiated at first power up and when the STANDBY/
READY button is pressed. The system will perform an internal verification process to determine
proper energy output and functionality of the laser system.
Treatment Pulse Counter Display/Reset Button

The treatment pulse counter and display/reset button indicate the number of times
the laser has been pulsed. This counter keeps track of the total number of laser
pulses used in a treatment session.
The pulse count is reset to zero by selecting and holding the treatment pulse reset button for
approximately 1 second or longer until it resets to 0 (zero).
Trigger Source Selection Display

The trigger source selection indicator displays how you are currently emitting treatment pulses,
either via the footswitch or the fingerswitch on the handpiece.
You may change this selection in the Settings screen (see System Settings on page 45). The
selector also acts as a toggle if it is pressed and held (for approximately one second until it changes).
STANDBY Mode
The operator selects STANDBY mode by pressing and holding the
STANDBY/READY toggle button. The changes to yellow and
“STANDBY” displays on the system status bar.
The Vbeam Prima laser system automatically enters STANDBY mode
during and following the initial verification process, which occurs when the laser system is first
powered up. If the laser system is not pulsed for two minutes, or if a fault condition is detected, the
laser system automatically transitions back to STANDBY mode.
READY Mode
Note
Anytime the laser system is in READY mode, an internal test pulse with no energy output occurs.
The operator selects READY mode by pressing the STANDBY/READY toggle button. The READY
symbol on the STANDBY/READY button changes to green and “READY” displays on the system
status bar. As a safety precaution, there is a delay of two seconds before the system enters READY
mode and the laser emission is enabled. An additional STANDBY/READY button illuminates on the
handpiece to indicate that the laser system is in READY mode.
While entering READY mode, the touch-screen displays a pop-up message instructing the operator
to wait for the audible beep, which indicates when the laser system is in READY mode.

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DCD Spray Settings
Press the DCD button on the Treatment screen (see Figure 18, arrow # N) to toggle between:
• Off mode
• 20 ms spray, 20 ms delay.
In addition to the four preset options, you may also insert proprietary settings of your own. Press and
hold the DCD button for 2-3 seconds, until the Custom DCD Settings pop-up window displays (see
Figure 19), and then adjust the Spray (ON), Delay (OFF), and/or Post settings as desired; press the
Close button to set the custom settings for this treatment session.
Figure 19: Custom DCD Settings Pop-Up (for illustration purposes only)

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Operating Parameters
The operating parameters that are configurable for laser treatments are
the fluence (J/cm2), pulse duration (ms) and repetition rate (Hz) settings.
The operating parameters are set individually by the operator.
To change the setting of an operating parameter, drag the dial settings to
the desired value or use the  &  buttons.
Laser Fluence (J/cm2) Settings

The fluence parameter is the amount of laser energy in Joules (J) delivered to the treatment spot size
(in cm2). The adjustable fluence setting is dependent on the spot size. Table 11 and Table 12 list the
available fluence settings for each spot size per laser wavelength. If the spot size is changed, the
laser system automatically selects the lowest possible fluence for the new spot size.
To change the setting of the laser fluence, drag the dial setting to the desired value.
Table 11: Laser Fluences per Spot Size – 595 nm
Spot Size; mm Fluence Range; J/cm2 Fluence Increments; J/cm2

3 11 - 40 0.5
3.5 10 – 38 0.5
4 8.5 – 35.5 0.5
4.5 7.5 – 33 0.25 / 0.5
5 6.25 – 30 0.25 / 0.5
5.5 5.5 – 28 0.25 / 0.5 / 1
6 5 – 27 0.25 / 0.5
6.5 4.5 – 25.5 0.25 / 0.5
7 4 – 24 0.25 / 0.5
7.5 4 – 22.5 0.25 / 0.5 / 1
8 3.75 – 22 0.25 / 0.5 / 1
8.5 3.5 – 19.5 0.25 / 0.5
9 3.25 – 17 0.25 / 0.5
9.5 3 – 15.5 0.25 / 0.5
10 3 – 14 0.25 / 0.5
10.5 2.75 – 12.5 0.25 / 0.5
11 2.5 – 11.5 0.25 / 0.5
11.5 2.25 – 10.5 0.25 / 0.5
12 2 – 10 0.25
12.5 2–9 0.25
13 2–9 0.25
13.5 2 – 8.25 0.25
14 2 – 7.75 0.25
14.5 2 – 7.25 0.25
15 2 – 6.75 0.25
3 x 10 Elliptical Tip
3 x 10 10 – 25 0.5

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Table 12: Laser Fluences per Spot Size – 1,064 nm Nd:YAG
Spot Size; mm Fluence Range; J/cm2 Fluence Increments; J/cm2

3 70 – 400 10 / 20
3.5 50 - 300 10
4 40 – 250 5
4.5 35 – 220 5
5 7 – 210 1/5
5.5 6 – 175 1/5
6 5 – 150 1/5
6.5 5 – 130 1/5
7 5 – 110 1/5
7.5 4 – 100 1/5
8 4 – 50 1/5
8.5 3 – 50 1/5
9 3 – 50 1/5
9.5 3 – 50 1/5
10 2 – 50 1/5
10.5 2 – 50 1/5
11 2 – 50 1/5
11.5 2 – 25 1
12 2 – 25 0.5 / 1 / 5
12.5 10 – 25 0.5 / 1
13 10 – 25 0.5 / 1
13.5 10 – 25 0.5 / 1
14 10 – 25 0.5 / 1
14.5 10 – 25 0.5 / 1
15 10 – 25 0.5 / 1
3 x 10 Elliptical Tip
3 x 10 30 – 200 5 /10

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Pulse Duration
The pulse duration parameter is the duration of the pulse delivered to the patient in milliseconds (ms).
It is adjusted manually by the operator on the Treatment screen. The available pulse duration
settings are:
• 595 nm: 0.45, 1.5, 3, 6 & 10-40 ms
• 1064 nm: 0.5, 3, 5 & 10-60 ms
To change the setting of the pulse duration, drag the dial setting to the desired value.
Pulse Repetition Rate

The repetition rate parameter is the rate of the pulses delivered to the patient in hertz (Hz). It is
adjusted manually by the operator on the Treatment screen. The maximum repetition rate settings
are:
• 595 nm: 1.5 Hz
• 1064 nm: 10 Hz
The actual pulse rate may vary by up to 20% from the selected rate. If the repetition rate is selected
for 1.5 Hz (Max. Dye) / 10 Hz (Max. YAG), depending on the parameters selected for the laser, the
system will perform as fast as it can to produce those selected parameters. In single pulse mode,
each pulse must be triggered by pressing and releasing the fingerswitch trigger or footswitch trigger.
To change the setting of the pulse repetition rate, drag the dial setting to the desired value.
Spot Size Identification (Tip Type)

When the delivery system is attached, and one of the handpiece tips are attached, the spot size
identification (lower-left corner of the Treatment screen) displays the available spot sizes on a
horizontal scale and states the selected diameter size.
The display also indicates which type of tip is connected.

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Treatment Application Options
The application options are limited to the handpiece tip and spot sizes available for the laser system
configuration and each treatment application. The laser system does not permit operators to use a
treatment application without a handpiece tip and supported spot size selected. Only use handpiece
tips and spot sizes that are supported by the desired treatment application.
Refer to the Vbeam Prima Clinical Treatment Guidelines (Candela Document Part Number 8505-10-
0391) to get the recommended preset treatment parameters and the handpiece tip and spot sizes for
the desired treatment applications. For instructions on performing a laser treatment, see System
Startup and Treatment Preparation on page 32.
Warning!
THE PRESET TREATMENT PARAMETERS AND OPERATOR’S MANUAL DO NOT TAKE THE
PLACE OF THE CANDELA CLINICAL GUIDELINES. FAILURE TO USE THE LASER SYSTEM IN
ACCORDANCE WITH SUCH PROCEDURES AND INSTRUCTIONS COULD RESULT IN SERIOUS
INJURY TO THE OPERATOR, PATIENT AND OTHERS, AS WELL AS DAMAGE TO THE LASER
SYSTEM.

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Guided Mode
Determining treatment parameter settings for particular clinical indications is a result of clinical
experience and expertise.
For the convenience of the operating clinician, the Vbeam Prima system is furnished with a set of
presets of treatment parameters, called Guided Mode. These presets are based on successful
results obtained by experienced physicians using the 595 nm laser wavelength.
1. Access Guided Mode by pressing the Guided Mode button on the Home screen (see Figure 17);
the mode’s initial screen will appear where you may select the Category of the lesion(s) to be
treated (see Figure 20). Press the desired bar to select the appropriate category from a drop-
down menu.
Figure 20: Guided Mode – Initial Screen; Select Lesion Category

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2. Pressing the desired Category opens a drop-down menu of Indications for that category of
lesions (see Figure 21). Press the appropriate bar for the desired indication (i.e., Angiomas).
Figure 21: Guided Mode – Lesion Category Screen; Select Indication
3. Pressing the desired Indication opens a drop-down menu of Sub-Indications for the selected
indication (see Figure 22). The screen displays the available sub-indications (i.e., Cherry
Angioma), and the available preset treatment-parameter protocols made available by the
system. Select the desired preset protocol by pressing and highlighting it on the screen.
Figure 22: Guided Mode – Lesion Category Screen; Select Indication

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4. After you have selected the Preset Protocol of treatment parameters, press the Start button
(see Figure 22); the Treatment screen will appear (see Figure 23), with all of the selected
parameters set in place. You may now transition the system to READY mode and begin the
treatment.
• The selected Indication and Sub-Indication are displayed in the bar at the top of the screen.
• The Spot sizes available for the above selections are displayed at the bottom of the screen.
• The outer ring on the Pulse Width dial (ms) indicates the pulse width’s range recommended
by the selected preset treatment protocol. If the set pulse width is within this range, the value
in center of dial changes its color to magenta.
• The outer ring on the Fluence dial (J/cm2) indicates the fluence range recommended by the
selected preset treatment protocol. If the set pulse width is within this range, the value in
center of dial changes its color to magenta.
Figure 23: Guided Mode – Treatment Screen

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End Treatment
Any time you press the End Treatment button, a Treatment Summary pop-up window will appear,
displaying the parameters you set, tip used, and pulses applied (see Figure 24).
● You may use this pop-up as an interim summary at any point during the treatment session,
afterwards pressing the Continue treating button to proceed with the session.
● A QR barcode containing the operating parameters set, tip used, and pulses applied appears
in the pop-up window.
● If the treatment session is indeed ended, press the End treatment button to transition the
system back to the Home screen (see Figure 17).
Figure 24: Treatment Summary Pop-Ups

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System Settings
The system Settings drop-down menu button allows access to several option configuration screens.
Note
The tabs described in the following sections correlate to Owner (administrator) or Service modes.
The screen that appears in User mode contains only the Device, Language, Clock and Your Account
tabs.
Device Tab
Refer to Figure 25:
Figure 25: System Settings Menu - Device Tab

Trigger Source
The trigger source selection button toggle between the fingerswitch and footswitch, where the laser
emission is initiated.
Dial Appearance
The parameter adjustment dials can be displayed with or without the ˄ and ˅ buttons, but it is
probably easier to make small adjustments using the buttons.
Aiming Beam Intensity Setting
The aiming beam intensity buttons allow the operator to select from three aiming beam intensity
levels or to turn OFF the aiming beam. The aiming beam, which is only visible in READY mode,
serves as a treatment area target as well as an emissions warning indicator.

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Note
To allow the user to see the intensity level being set, the aiming beam is turned on during the selection
process.
Language Tab
Refer to Figure 28:
Figure 26: System Settings Menu - Language Tab
User Interface Language Selection

The flag buttons allow the operator to select which language the touch-screen displays.
User Interface Convention Formats

Pressing these buttons open drop-down menus where you may change how the formats of Numbers,
the system Date and Time will be displayed.
Save Button
The save button saves/confirms the changes made on the screen.

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Clock Tab
Refer to Figure 27:
Figure 27: System Settings Menu - Clock Tab
System Date and Time Settings

Use the – or + buttons in both columns to set the current date and time as the system settings. Press
the  button to set the current date and time to the system’s memory.
Date and Time Format Settings

Use the drop-down menus in both Date and Time drop-down menus to set the desired format.
Save Button
The save button saves/confirms the changes made on the screen.

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Your Account Tab
Refer to Figure 28:
Figure 28: System Settings Menu - Your Account Tab
On this screen you may change the existing password pattern or change the password entry mode to
a numerical Personal Identification Number (PIN) password or eliminate the password requirement
altogether (not recommended).
● Press the Change password button.
● Enter the current password pattern.
Figure 29: Enter Current Password Pattern

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● Create a new password pattern.
Figure 30: Enter New Password Pattern
OR:
● Mark the Use PIN password check box and enter a new numerical PIN number via the
virtual keypad. Press the OK button on the virtual keypad to save the new password.
Figure 31: Enter Numerical PIN Password

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Startup Policy Tab
Refer to Figure 32:
Figure 32: System Settings Menu - Startup Policy Tab
In this screen, you may set the configuration of the system when it is started up (login process):
● Remember last logged user? Yes or No.
● Start with [account type]: press the Select Account button for a pop-up where you may
select the account type that the system will start up with - Owner (administrator) or User
(care giver).
● Log in automatically? Yes or No. if you change this setting to Yes, the login process will
complete without having to enter a password.
Note
Only the system administrator is allowed to make these changes.
Warning!
CANDELA CORPORATION STRONGLY RECOMMENDS AGAINST USING THIS OPTION! IF YOU
DO SET THIS OPTION, TAKE EXTREME CARE THAT NO UNAUTHORIZED PERSONNEL ARE
ALLOWED UNSUPERVISED ACCESS TO THE VBEAM PRIMA SYSTEM.

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Accounts Tab
Refer to Figure 33:
Figure 33: System Settings Menu - Accounts Tab
In this screen you may add new account holders to the system’s database or edit existing ones;
select the level of account holder you wish to add, User, Owner or Manager, and then press the New
or Edit button. Figure 34 displays the two screens. Set the account holder’s Type (User, Owner or
Manager), Password (pattern or numerical), Permissions and Account Status.
Figure 34: Add New or Edit Existing Accounts
Note
Only the system administrator is allowed to make these changes.

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Network Tab
Refer to Figure 35:
Figure 35: System Settings Menu - Network Tab
In the Network tab (see Figure 35), you may adjust or perform the following system settings or
functions:
Change the system's name.
Enable and configure the system's Wi-Fi connection to your local wireless network.
Figure 36: WiFi Configuration Pop-Up
To configure the Wi-Fi connection, press the Configure… button; a WiFi Configuration pop-up will
appear (see Figure 36).
Select the name of your office Wi-Fi wireless network by tapping it; the Password pop-up will appear.
Enter the network security key using the displayed virtual keyboard and press Connect.

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Other System Functions and displays
System Lock Function
The lock button protects the system settings from unauthorized changes. The system can be
unlocked with this password: 1 2 3 4.
Figure 37: System Lock
Log Out Function

The proper way to shut down the system at the end of the day’s procedures is as follows:
1. Log out of the operating system by pressing the Log out button in the drop-down menu.
2. Press the Yes button to confirm and transition the system to the initial splash screen.
3. Turn the circuit breaker switch on the system’s rear panel to the OFF position.
Figure 38: Log Out

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Status Displays
Press the Status button in the drop-down menu to display the initial Status screen. This screen will
display any relevant messages that you should act on (see Figure 39).
Touch the various tabs to access several tabs (see Figure 40 through Figure 45) to view information
pertaining to all facets of the Vbeam Prima system’s hardware, firmware and software. You may be
asked for any details of this information by Candela service personnel in their efforts to assist you
with troubleshooting problems that may arise during the system’s service life.
Figure 39: Status Messages
Figure 40: Status: Status Tab

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Figure 41: Status: Recent Faults Tab
Figure 42: Status: Recent Pulses Tab

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Figure 43: Status: Pulse Counters
Figure 44: Status: Hardware Tab

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Figure 45: Status: Firmware Tab
Save LVM (Laser Variable Mode) Button

From any of the Status screens you may to save the laser variable mode information to a USB flash
drive.
The laser variable mode information is used by Candela service personnel to diagnose problems or
obtain laser system operating information.
1. Insert a USB flash drive into the system’s USB connection port.
2. Press the Save LVM button; select Save LVM to USB to back up and archive the system’s
LVM report, OR:
3. Select Send LVM to the Candela service department as requested by your service
representative.
Figure 46: Save LVM On-Screen Instructions

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Purge Button
The Purge button is used to remove air bubbles from the DCD cryogen line when a
new canister is placed in the system or a handpiece is installed. This action must be
performed with the handpiece removed from the calibration port and pointed in a
safe direction. When pressed, the handpiece will disperse cryogen spray for the
selected spray duration. If the button is held for longer than 1 second, a short spray
and then a longer spray of cryogen (up to 3 seconds) will be dispersed.
Other Controls
Remote (CDRH) Interlock
The remote interlock connector, located on the Service panel of the laser system (see Figure 47),
above the power cable, may be connected to one or more switches on the treatment room door(s).
When the interlock is connected, the laser system shuts down if treatment 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 the remote interlock is not in use, the supplied
jumper must be plugged into the interlock connector.
Footswitch Connector
The footswitch connector is located on the laser system’s Service panel (see Figure 47). To enable
the footswitch, press the Settings button and press the footswitch button; the fingerswitch will be
disabled.
Figure 47: Mains Circuit Breaker and Remote Interlock

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Section 4: Clinical Guide
Indications for Use

595 nm
• General Surgery:
• Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
• Dermatology/Plastic Surgery:
 For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia,
rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte,
and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of
wrinkles.
• Treatment of Benign Epidermal Pigmented Lesions.
• Treatment of Inflammatory Acne Vulgaris.
• Gynecology:
 Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
• Podiatry:
 Treatment of benign cutaneous lesions, such as warts.
1,064 nm
The Vbeam Prima laser system is intended for the coagulation and hemostasis of benign vascular
lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea,
Venus lakes, leg veins, spider veins, and poikiloderma of Civatte and treatment of benign cutaneous
lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café-au-lait
macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also
indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles.
Contraindications and Precautions

• Accutane: wait 12 months after the completion of Accutane therapy.
• Tattoos: do not treat tattooed skin, including decorative, permanent makeup and radiation port
tattoos.
• History of photosensitivity to 595 or 1064 nm light.
• Pregnancy
• Seizure disorders: do not treat patients with a history of light-triggered seizures.
• Medications: daily anticoagulation therapy, iron supplements, vitamin E, fish oil, herbal
supplements such as ginkgo, ginseng or garlic may interfere with the treatment.
• Photosensitizing medications: medications that induce photosensitivity or medications within or
above the 595 nm wavelength. Refer to Candela’s list of drugs that may cause photosensitivity.
Stop the medication if possible, for 3-5 days prior to treatment.

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• Topical medications and skin care products: stop 72 hours pre- and post-treatment. Self-tanning
products must be removed.
• Herpes Simplex Virus (HSV) 1 & 2: do not treat if active lesion(s) are present within the intended
treatment area. Patients with a known history of frequent HSV 1 & 2 lesions should begin
prophylaxis prior to treatment as prescribed by their physician.
• Active skin infection: avoid treatment of open wounds and skin that is actively infected.
• Cold sensitivity: use caution when treating patients with Raynaud’s phenomenon.
• Keloid scarring: perform test spots prior to treating larger areas.
• Implanted medical devices: pacemakers, cardioverters and other implantable devices or fillers:
consult with your physician prior to treatment.
• Use caution when treating recently tanned skin. Blisters and hyper/hypopigmentation may occur,
allow tan to fade prior to treatment to reduce this risk. When in doubt, perform test spots on
tanned and untanned areas for comparison before proceeding.
• Treatment of warts may result in hypopigmentation or a scar.
Possible Adverse Effects

• Itching (hive-like response).
• Burning, blistering, scabbing, crusting, color and/or texture changes.
• Herpes simplex activation.
• Hyperpigmentation (darkening of the skin, transient or long term).
• Hypopigmentation (lightening of the skin; transient, long term or possibly permanent).
• If hypo- or hyperpigmentation occurs, treatment should not be performed until pigmentation
returns to normal.
• Scarring (rare, possibly permanent).
Warnings and Precautions Concerning the Use of Cryogen

(DCD Cooling)
• Do NOT spray cryogen into the eyes or into an open wound.
• The DCD spray should be sufficient to cover the treatment area and provide epidermal cooling to
offset the heat generated by the laser. It is important to maintain both skin protection and patient
comfort.
• Begin with suggested guidelines and increase or decrease settings based on the skin reaction
and the patient’s tolerance.
• Darker skin types do not tolerate excessive amounts of DCD spray. Use caution when increasing
DCD spray time on darker skin types. Pre- and post-cooling with a cold compress may add to the
patient’s comfort.
• When using the Vbeam Prima laser with multiple pulses, the user should monitor the distance
gauge condition and wipe the distance gauge as required. After approximately 30 pulses, check
the condition of the distance gauge for hair, cryogen buildup, etc. Wipe if necessary, before
continuing treatment.

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• Special considerations when the Vbeam Prima system is not equipped with the dynamic cooling
device (DCD):
 If the DCD option is not installed and cooling is desired, another method of cooling (air
cooling or contact cooling, etc.) should be utilized.
 Several applications including non-facial warts and benign epidermal pigmented lesions are
treated without DCD cryogen spray. Application of a cool compress post-treatment may
enhance patient comfort.
Additional Warnings and Precautions

A buildup of frost may occur on the distance gauge during extended treatments. Wipe the distance
gauge with a warm, moist cloth to prevent accumulation of frost.
• If crescent shaped marks, welts or wheals are noted during treatment, the fluence and or
DCD settings should be adjusted immediately. Failure to adjust these parameters can result
in subsequent crusting, blistering, or other adverse reactions. Crescents may result from not
holding the distance gauge properly. If the problem persists, discontinue treatment and refer
to the User Verification test section in the operator’s manual.
• Do not use flammable products on the skin or in the vicinity of the laser.
• When using the Vbeam laser with the Dynamic Cooling Device (DCD), in conjunction with an
ECG monitoring device, interference with the ECG monitoring device may result.
• Oxygen will accelerate combustion of any flammable material. Oxygen should never be
directed towards or over the laser field, and extreme caution should be used. When oxygen is
in use, gauze, sponges and hair near the treatment area should be moistened with water. Be
aware that hairspray, gel, deodorants and other grooming products may contain flammable
substances.
• Treatment to areas bearing hair may cause the hair to be singe and may cause it to ignite. A
fire extinguisher should be available.

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Section 5: Laser System Start-Up
Laser System Start-Up Procedure

Follow the steps given below to perform a Vbeam Prima laser system start-up:
1. Cover treatment room windows with an opaque material to prevent unintended viewing.
2. Post laser warning sign at each entrance to the laser treatment room.
3. Ensure the proper protective eyewear is available. Proper eyewear will filter light at a
wavelength of:
● 592–596 nm with a minimum OD (Optical Density) rating of 5.0 or greater.
● 1062–1066 nm with a minimum OD rating of 5.0 or greater.
4. Plug the laser into the correct electrical outlet. Ensure that the Mains Switch (circuit breaker)
on the rear panel is in the ON position.
5. Install the delivery system with the desired spot size distance gauge inserted. Insure that the
fiber connector nut at the laser is tight and secure.
6. Set up the delivery system on the fiber support pole.
7. Inspect and verify that the handpiece, distance gauge and the windows (internal handpiece
window; the input and output distance gauge windows) are clean.
WARNING!
ALWAYS PUT THE LASER SYSTEM INTO STANDBY OR “OFF” AND REMOVE THE DISTANCE
GAUGE FROM THE HANDPIECE BEFORE ATTEMPTING TO CHECK, CLEAN AND/OR
REPLACE THE DELIVERY SYSTEM, DISTANCE GAUGE, WINDOW(S) AND/OR PL LENS.
Warning!
ALWAYS RECALIBRATE THE LASER AFTER FIXING, CLEANING OR REPLACING THE
DELIVERY SYSTEM, DISTANCE GAUGE, ANY WINDOW(S) AND/OR PL LENS. FAILURE TO
INITIATE A CALIBRATION AFTER CLEANING/REPLACING THE DISTANCE GAUGE, WINDOW(S)
OR DELIVERY SYSTEM MAY RESULT IN THE DELIVERY OF EXCESSIVE LASER ENERGY.
8. To start the laser system, press the ON/OFF button on the right side of the display monitor.
There may be a delay of several seconds before the system initializes. This is normal. The
system will enter warm-up mode (approx. 20 minutes). After the warm-up is complete, the
display monitor will transition to Welcome screen and request your password.
9. A Welcome pop-up will appear on the display monitor with several safety prompts and
recommendations. Press the OK button to clear the pop-up.
10. Put on safety eyewear.

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11. Choose the preferred System Settings:
● Select the preferred language
● Select Fingerswitch or Footswitch Mode
● Select Repetition Rate (Single or Multi-pulse)
● Select Aiming Beam Intensity Level
12. Close the System settings window (by pressing the “Checkmark” button if you wish to save
the current system setting) and perform the User Verification Tests.
Warning!
ALWAYS PERFORM THE USER VERIFICATION TESTS PER SECTION 5 OF THIS MANUAL TO
CHECK THE DELIVERY SYSTEM AND DISTANCE GAUGE FOR PROPER OPERATION AT THE
BEGINNING OF EACH TREATMENT DAY OR EACH TIME IT IS REPLACED ON THE LASER
SYSTEM. IN ADDITION, USE THE USER VERIFICATION TESTS TO CHECK THE DELIVERY
SYSTEM AND/OR DISTANCE GAUGE IF THERE IS AN UNEXPLAINED TREATMENT RESPONSE
NOTED OR THE DELIVERY SYSTEM AND/OR DISTANCE GAUGE HAS BEEN DROPPED.
DISCONTINUE USE OF YOUR LASER DELIVERY SYSTEM OR DISTANCE GAUGE IF YOU
SUSPECT A PROBLEM.
13. Select the desired spot size and install the appropriate Distance Gauge onto the handpiece.
The selected spot size will appear as a blue-filled circle or ellipse on the user interface
screen.
14. Select the desired laser system operating parameters (consult the Treatment Guidelines):
• Select parameters for an available treatment application that supports the distance gauge
spot size (installed in Step 13).
• Verify that the Fluence, Pulse Duration and DCD Settings are within the desired
treatment parameters for the current patient treatment.
• If needed, adjust the operating parameter(s) by pressing the up or down arrows to adjust
the value(s) to the desired setting(s).
• Set DCD for desired spray duration and delay parameters (Treatment dependent)
Note
If you have trouble setting the operating parameters, check to ensure the settings are allowed for the
selected spot size and distance gauge.

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03-FEB-20
15. Press the READY button (if in STANDBY) on the Treatment screen. The first time this is
done after a system startup, the system will perform an internal calibration for approximately
one minute. The handpiece does not need to be in the verification port for this step.
Note
After a calibration is completed, the laser will remain in READY mode.
16. Press the READY button (if in STANDBY) on the Treatment screen. Do not press the
fingerswitch or the footswitch to pulse the laser. Aim the handpiece at a white piece of paper
and inspect the aiming laser beam for circular uniformity and clarity. If the aiming beam spot
is not uniform, press the STANDBY button to set the laser to STANDBY mode. Check for
distance gauge interference. Fix or clean distance gauge per Section 5 of this manual or
replace if correct results cannot be achieved. Repeat steps 14 – 16 until satisfactory results
are achieved. Important: Always recalibrate the laser after fixing, cleaning or replacing
the delivery system, distance gauge or window(s). Failure to initiate a calibration after
cleaning/replacing the parts may result in delivery of excessive laser energy.
Important!
Do not operate the laser if the 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 Technical Support.
17. (OPTIONAL) If desired, the user can verify the transmission of the fiber delivery system
following the internal calibration.
a. Ensure that the delivery system and distance gauge are clean; instructions start on
page 71.
b. In READY mode, place the handpiece in the verification port and follow the on-screen
prompts.
c. When complete, remove the handpiece from the verification port.
18. Perform the laser treatment.
19. Set the laser to STANDBY mode after use. Document laser use. When in STANDBY mode,
the operator can then adjust the laser output parameters as needed without the need to
recalibrate while the system is on.
Notes
To reset the pulse counter to zero, press the Pulse Count Reset button on the Treatment screen
for 2 seconds.

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03-FEB-20
Important!
Do not operate the laser if the 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 Customer Service.
Notes
● To return the pulse counter to zero, press the Pulse Count Reset button on the Treatment
screen for 2 seconds.
● The laser system will not allow treatment pulses until a calibration has been performed after
any one of the following conditions:
a. Laser is turned on.
b. Fluence or Pulse Duration parameter changed.
c. Delivery system changed.
d. The distance gauge position changed or became disconnected from the handpiece.
e. Specific faults occur.
f. In STANDBY mode for more than 30 minutes.
● The user must remember to initiate a calibration after cleaning or replacing the window(s) in
the distance gauge.
Notes
● If the desired Fluence cannot be reached, one of two messages will appear (depending on
software version):
● Lower Fluence: The Lower Fluence message simply is telling the user to go out to the main
screen and manually select a lower fluence.
● MAX FLUENCE = XX J/cm2: The Max Fluence message means that the laser automatically
set itself to the highest available fluence.
● This condition indicates that the system may need a new fiber, dye kit or laser head. Call
Candela Customer Service. If a higher Fluence is desired immediately, reduce spot size.

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03-FEB-20
Section 6: Maintenance, Troubleshooting and Delivery
System Verification Tests
Notes
• To reset the pulse counter to zero, press the Pulse Count Reset button on the Treatment
screen menu for 2 seconds.
• No modification of this equipment is allowed.
Caution!
● THE VBEAM LASER SYSTEM IS TO BE INSTALLED AND SERVICED ONLY BY QUALIFIED
AND AUTHORIZED TECHNICIANS WHO HAVE RECEIVED APPROPRIATE TRAINING FROM
CANDELA. ANY ATTEMPT BY AN UNAUTHORIZED PERSON TO PERFORM ANY SERVICE
PROCEDURE MAY RESULT IN A PERSONAL INJURY AND WILL VOID ANY WARRANTY ON
THE LASER SYSTEM.
● REFERENCE DOCUMENT: VBEAM SERVICE MANUAL (P/N # 8501-00-1795).
Warning!
THE ELECTRICAL AND LASER RADIATION HAZARDS PRESENT WHILE SERVICING THE
VBEAM LASER SYSTEM CAN BE EXTREMELY DANGEROUS IF PROPER SAFETY
PRECAUTIONS ARE NOT TAKEN.
User maintenance should take place daily (when system is used continuously) unless otherwise
specified.

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03-FEB-20
Laser Software and System Upgrades
Be sure to inquire with your Candela Sales Representative or Customer Service regularly to check for
the latest updates on Vbeam Prima laser software and system upgrades.
Laser System Software Upgrade USB Port and USB Flash Drive
Minor laser system software upgrades can be performed at the convenience of the authorized user(s)
without the presence of a Candela Service Representative. The laser system software upgrades will
be shipped on USB devices with instructions. The instructions will provide simple steps and procedures
to verify that the upgrade is completed successfully. The USB Ports are located on the rear of the
display monitor (see Figure 48). Follow the instructions and procedures provided with each software
upgrade.
Figure 48: Laser System Software Upgrade USB and Flash Drive Ports
Warning!
ALWAYS FOLLOW ALL INSTRUCTIONS AND PERFORM ALL PROCEDURES PROVIDED WITH
EACH USB SOFTWARE UPGRADE KIT TO INSURE THE FULL AND COMPLETE INSTALLATION
OF THE LASER SYSTEM SOFTWARE UPGRADE.
Laser System Upgrades

Vbeam Prima laser system upgrade options are available to customers who wish to upgrade their
laser system to add a wider range of laser treatment parameters and spot sizes. Contact Candela
Customer Service for additional information. Major laser system upgrades can only be performed by a
Candela Service Representative.

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03-FEB-20
Fiber-Optic Delivery System
Warning!
ALWAYS PUT THE LASER SYSTEM INTO “STANDBY” OR “OFF” AND REMOVE THE DISTANCE
GAUGE FROM THE HANDPIECE WHEN CHECKING, CLEANING AND/OR REPLACING THE
DELIVERY SYSTEM, DISTANCE GAUGE, LENS AND/OR WINDOWS.
The Vbeam Prima laser delivery system utilizes fiber optics that can be damaged if subjected to
excessive bending. To avoid damage to the optical fiber, limit bends to a radius of 5 inches (13 cm) or
greater.
The delivery system should be checked before each procedure by observing aiming 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 window(s) 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. Important: Always recalibrate the laser after fixing, cleaning or
replacing the delivery system, distance gauge, window(s) and/or PL lens. Failure to initiate a
calibration after cleaning/replacing the parts may result in delivery of excessive laser energy.
Always cap the proximal connector of the fiber with the attached rubber cap whenever the fiber is not
installed on the laser.

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03-FEB-20
Windows and Lens
Warning!
ALWAYS PUT THE LASER SYSTEM INTO “STANDBY” OR “OFF” AND REMOVE THE DISTANCE
GAUGE FROM THE HANDPIECE WHEN CHECKING, CLEANING AND/OR REPLACING THE
DELIVERY SYSTEM, DISTANCE GAUGE, LENS AND/OR WINDOWS.
Due to the nature of some procedures, the window and lens will require frequent cleaning and/or
replacement to maintain proper system performance. They should be maintained in accordance with
the cleaning and disinfection procedures given in this section. Assembly pictures and procedures
specific to the Vbeam Prima delivery systems are included in this section.
The distance gauge assembly contains a window to protect the delivery system optics and its internal
lenses (see Figure 49).
Distance Gauge Ring (Treatment End)

O- Ring
Window
Non- Treatment End
Distance Gauge Body
Figure 49: Distance Gauge Windows

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03-FEB-20
The handpiece contains one internal handpiece window that can be installed or removed
easily using the Window Removal Tool supplied with each laser (see Figure 50).
Handpiece Window (Internal Window)
Handpiece
Handpiece Window Removal Tool
Figure 50: Handpiece Window and Removal Tool

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03-FEB-20
Cleaning and Disinfection
Warning!
● ALWAYS PUT THE LASER SYSTEM INTO “STANDBY” OR “OFF” AND REMOVE THE
DISTANCE GAUGE FROM THE HANDPIECE WHEN CHECKING, CLEANING AND/OR
REPLACING THE DELIVERY SYSTEM, DISTANCE GAUGE, LENS AND/OR WINDOWS.
● ALWAYS RECALIBRATE THE LASER AFTER FIXING, CLEANING OR REPLACING THE
DELIVERY SYSTEM, DISTANCE GAUGE, WINDOW(S) AND/OR LENS. FAILURE TO INTIATE
A CALIBRATION AFTER CLEANING/REPLACING THE WINDOW(S), LENS, DISTANCE
GAUGE AND/OR DELIVERY SYSTEM MAY RESULT IN THE DELIVERY OF EXCESSIVE
LASER ENERGY.
● ALWAYS PERFORM THE USER VERIFICATION TESTS PER SECTION 5 OF THIS MANUAL
TO CHECK THE DELIVERY SYSTEM AND DISTANCE GAUGE FOR PROPER OPERATION AT
THE BEGINNING OF EACH TREATMENT DAY OR EACH TIME IT IS REPLACED ON THE
LASER SYSTEM. IN ADDITION, USE THE USER VERIFICATION TESTS TO CHECK THE
DELIVERY SYSTEM AND/OR DISTANCE GAUGE IF THERE IS AN UNEXPLAINED
TREATMENT RESPONSE NOTED OR THE DELIVERY SYSTEM AND/OR DISTANCE GAUGE
HAS BEEN DROPPED. DISCONTINUE USE OF YOUR LASER DELIVERY SYSTEM OR
DISTANCE GAUGE IF YOU SUSPECT A PROBLEM.
The Laser System

The exterior of the laser system may be cleaned weekly with a soft cloth slightly 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 hospital-grade disinfectant or alcohol solution.
The Delivery System Handpiece

The outer shell and internal window of the Delivery System Handpiece need to be kept clean and free
of residue build up. The procedures given below provide instructions for the proper
cleaning/disinfection of the Delivery System Handpiece outer shell and its internal window.
To clean and disinfect the handpiece:

Immediately after each treatment session, set the laser to STANDBY mode, and wipe the exterior
surface of the handpiece body with a gauze pad moistened with a hospital-grade disinfectant solution
or alcohol solution. Take care to avoid contaminating the internal optical surfaces of the handpiece.
After cleaning the handpiece, dry the area thoroughly prior to the beginning of a laser procedure.
To clean or replace the handpiece window:

This procedure requires the use of the Handpiece Window Removal Tool shown in Figure 50
(Candela P/N 7123-00-0494).
1. Turn OFF the laser system.

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03-FEB-20
2. Remove any distance gauge that may be inserted in the handpiece and set aside.
3. Wear dustless gloves to prevent smudges or fingerprints on the handpiece window.
4. Fully slide the Handpiece Window Removal Tool in the handpiece port with the “OUT” arrow
pointing in the OPPOSITE direction away from the laser aperture. (Note: The “OUT” arrow
indicates the direction in which the handpiece internal window will be removed.)
5. Slowly rotate the window removal tool to make a ¼ turn in a counterclockwise or clockwise
direction. This will exert a magnetic pull on the handpiece internal window causing it to attach
itself to the Window Tool.
6. Slowly pull the window removal tool out in the direction of the “OUT” arrow. The handpiece
window should be magnetically attached to the proximal end of this tool.
7. Remove the Handpiece Window from the tool to clean.
• Clean the window with a lint free tissue or towelette moistened with clean isopropyl
alcohol. Wipe only once with each tissue.
• Re-inspect the window. If unacceptable, discard window and replace with a new one.
8. Grasp the clean or new window by the edges and magnetically attach it to the other end of
the Window Tool where the “IN” arrow is located (The red markings are in the same direction
as the “IN” arrow).
9. Carefully slide the window removal tool in the direction of the “IN” arrow back in the
handpiece until it comes to a full stop.
10. Slowly rotate the window removal tool to make a ¼ turn in a counterclockwise or clockwise
direction. This will release the handpiece window from the Window Removal Tool.
11. Slowly pull the window removal tool out. Verify that the handpiece window is no longer
attached to the tool and that it attached itself inside the handpiece.
12. Hold the handpiece under a bright light to verify that the handpiece window is fully connected
to the movable lens cartridge inside the handpiece.
13. Reinsert the distance gauge. The distance gauge should be able to slide in without any
obstacles. If unable to insert the Distance Gauge, the handpiece window may not be properly
set. Repeat Steps 2-12 until the handpiece window can be properly set in place.
Warning!
ALWAYS VERIFY THAT THE HANDPIECE WINDOW IS PROPERLY SET IN ITS PLACE.
14. Turn on the laser system and allow it to warm-up.
Warning!
ALWAYS PERFORM A LASER CALIBRATION AFTER REPLACING/CLEANING A DIRTY OR
BURNT WINDOW OR LENS.

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03-FEB-20
Distance Gauges
The distance gauge is the only part of the handpiece to contact the patient. This is an item that should
be replaced when signs of degradation or difficulty in cleaning occur. Proper care will result in
improved laser performance.
Warning!
● ALWAYS PUT THE LASER SYSTEM INTO “STANDBY” OR “OFF” AND REMOVE THE
DISTANCE GAUGE FROM THE HANDPIECE WHEN CHECKING, CLEANING AND/OR
REPLACING THE DELIVERY SYSTEM, DISTANCE GAUGE, LENS AND/OR WINDOWS.
● ALWAYS PERFORM THE USER VERIFICATION TESTS PER SECTION 5 OF THIS MANUAL
TO CHECK THE DELIVERY SYSTEM AND DISTANCE GAUGE FOR PROPER OPERATION
AT THE BEGINNING OF EACH TREATMENT DAY OR EACH TIME IT IS REPLACED ON THE
LASER SYSTEM. IN ADDITION, USE THE USER VERIFICATION TESTS TO CHECK THE
DELIVERY SYSTEM AND/OR DISTANCE GAUGE IF THERE IS AN UNEXPLAINED
TREATMENT RESPONSE NOTED OR THE DELIVERY SYSTEM AND/OR DISTANCE GAUGE
HAS BEEN DROPPED. DISCONTINUE USE OF YOUR LASER DELIVERY SYSTEM OR
DISTANCE GAUGE IF YOU SUSPECT A PROBLEM.
● ALWAYS RECALIBRATE THE LASER AFTER FIXING, CLEANING OR REPLACING THE

DELIVERY SYSTEM, DISTANCE GAUGE, WINDOW(S) AND/OR LENS. FAILURE TO INTIATE
A CALIBRATION AFTER CLEANING/REPLACING THE WINDOW(S), LENS, DISTANCE
GAUGE AND/OR DELIVERY SYSTEM MAY RESULT IN THE DELIVERY OF EXCESSIVE
LASER ENERGY.

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03-FEB-20
The Distance Gauges
Each assembly has an outer housing and a window that need to be kept clean and free of residue
build up. The procedure below provides instruction for the proper cleaning/disinfecting of the distance
gauges.
To Clean/Disinfect the housing shell and mask:
1. Clean the distance gauge mask, post and exposed section of the housing with a gauze pad
moistened with hospital-grade disinfectant or equivalent.
2. Be sure not to wipe the green circuit board on the distance gauge (see Figure 51).
DO NOT CLEAN ANY PART OF

THIS GREEN BOARD.
Clean Mask, post, and front surface.
Figure 51: Distance Gauge Cleaning

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03-FEB-20
Caution!
● DO NOT USE HEAT, STEAM OR AUTOCLAVES TO STERILIZE THE DISTANCE GAUGE
OR COMPLETELY SUBMERGE IT IN CLEANING SOLUTIONS OR WATER. USE A PAD
MOISTENED WITH DISINFECTANT OR ALCOHOL SOLUTION TO WIPE CLEAN THE
DISTANCE GAUGE AS INSTRUCTED IN THIS MANUAL OR DAMAGE TO THE
DETECTION ELECTRONICS MAY OCCUR.
● DO NOT DISASSEMBLE THE DISTANCE GAUGE TO PERFORM REPAIRS. ONLY CLEAN
OR REPLACE THE DISTANCE GAUGE WINDOWS OR LENS AS INSTRUCTED IN THIS
MANUAL.
● ONLY USE VBEAM PRIMA REPLACEMENT WINDOWS IN THE DISTANCE GAUGE OR
PERMANENT DAMAGE MAY OCCUR.
● THE DISTANCE GAUGE, IT'S WINDOWS, AND THE LENS MAY BECOME SOILED WITH
NORMAL USAGE. TO ENSURE PROPER FLUENCE DELIVERY, IT IS IMPORTANT TO
INSPECT AND CLEAN THE DISTANCE GAUGE, ITS WINDOWS AND THE LENS
FREQUENTLY SO DEBRIS DOES NOT GET BURNED INTO THE WINDOW OR LENS
SURFACE.
● WHEN THE DISTANCE GAUGE WINDOWS OR LENS BECOME DIRTY OR BURNT, THE
AMOUNT OF ENERGY DELIVERED TO THE PATIENT MAY BE REDUCED. THEREFORE,
AFTER REPLACING/CLEANING A DIRTY OR BURNT DISTANCE GAUGE WINDOW OR
LENS, ALWAYS RECALIBRATE THE LASER.
To clean or replace the distance gauge windows:

1. Wear dustless gloves to prevent smudges or fingerprints on the lens.
2. Set the laser to STANDBY mode and remove the distance gauge assembly from the handpiece.
3. The window is located at the end of the Distance Gauge (treatment end). It is held in groove by
the O-ring. A notched access opening near the edge of the groove end allows easy removal of
the O-ring (see Figure 51).
4. With the non-treatment end of the Distance Gauge facing downwards, remove the O-ring from the
treatment end 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.
6. Clean the window:
• Clean the window with a lint free tissue or towelette moistened with clean isopropyl alcohol.
Wipe only once with each tissue.
• Re-inspect the window. If unacceptable, discard the 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 so that
it is resting flat on the ledge. 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.
8. Re-insert the Distance Gauge back into the handpiece.

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03-FEB-20
Note
Only use Vbeam Prima replacement windows in the distance gauge or permanent damage may occur.
Delivery System Replacement

1. Verify the laser system is in STANDBY mode or OFF.
2. Remove the system’s rear cover by placing fingers underneath the two tabs and pulling
backwards and up. Set rear cover aside.
Figure 52: Removing the Rear Cover

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03-FEB-20
3. Remove the Delivery System from the Arm Support Pole: Remove the arm support clips by
un-threading both cable harnesses through the arm support pole’s opening; remove the delivery
system from the laser system.
Figure 53: Fiber Support Pole Assembly

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03-FEB-20
4. Disconnect the delivery system’s cable harnesses (see Figure 54):
• For the CC handpiece; remove the water connection tubes by pressing on the quick-connect
tabs (A).
• For the DCD handpiece; remove the DCD line by pushing the metal connector until the cable
is released, then remove the cable (B).
• Release the laser’s fiber-optic cable from its connection port (C).
Figure 54: Delivery System Verification Ports
A Delivery System Coolant Connections

B Delivery System Power Connection
C Delivery System Fiber Connection

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03-FEB-20
A Control Button
B Optical Adjustment Knob
C Contact Cooling Tip /
Distance Gauge
D Laser Aperture (under
A B protective window)
Figure 55: Handpiece Delivery System; Close-Up View
Figure 56: Verification Port (“Verification Port”)

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03-FEB-20
GentleCool Pro Cryogen Canister
Caution!
THE CONTENTS OF THE CRYOGEN CANISTER ARE UNDER PRESSURE. READ THE MSDS
CANDELA P/N 8501-00-1701 AND THE LABEL ON THE CANISTER BEFORE HANDLING.
Cryogen Canister Replacement

To replace a DCD canister please follow these easy steps:
1. With the laser turned OFF, pull the empty canister out of the laser system.
2. Install the new canister by placing it into the DCD receptacle and gently pushing it into place
until it the two retention brackets lightly snap into place.
3. Turn the laser on and allow it to warm up
4. Verify that the laser system is in STANDBY mode.
5. Point the delivery system handpiece away from objects and bystanders (toward the floor).
Press the Purge button several times until all air bubbles have been purged out of the
handpiece.
6. Perform the User Verification Tests given later in this Section.
Figure 57: Cryogen Canister Replacement

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03-FEB-20
Cryogen Leak
For additional information, refer to the MSDS sheets (Candela P/N 8501-00-1701) supplied with each
cryogen canister.
Canister Disposal
The canister can be disposed of by a waste disposal company or completely by emptying it (as per
the instructions enclosed with each canister) and disposing of it in the trash. Refer to Environmental
Protection: Disposal Hazards and Guidance in this manual.

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03-FEB-20
Laser Dye Solution Cartridge
The Vbeam Prima laser system routinely monitors the laser beam energy output and the wavelength
of the laser dye solution. After many pulses or an extended period, the absorbency of the dye
eventually deteriorates and reduces the energy output of the laser. When this happens, the Vbeam
Prima dye cartridge must be replaced by a Candela Service Representative to restore the energy.
Caution!
The laser dye solution cartridge may be replaced ONLY by Candela authorized service
personnel.
WARNING!
THE LASER DYE CARTRIDGE AND ITS CONNECTING SYSTEM COMPONENTS CONTAIN THE
LASER DYE AND TRIPLET QUENCHER SOLUTION WHICH IS A TOXIC AND FLAMMABLE
HAZARDOUS MATERIAL. THIS HAZARDOUS MATERIAL AND/OR WASTE SHOULD BE
HANDLED AND DISPOSED OF ONLY BY TRAINED AND AUTHORIZED OERSONNEL.
In Case of a Spill or Exposure to the Laser Dye Solution

The dye solution may be harmful by inhalation, ingestion or skin absorption. Handle the used dye
cartridge with care at all times. Refer to the Vbeam Prima Cartridge MSDS Candela (P/N 7121-90-
9940) for more complete information. The toxicity and health hazard data of the dye solution has not
been established.
Following a spill or exposure:
1. Evacuate the area and close off to all personnel.
2. In case of eye contact, immediately flush eyes with water for at least 15 minutes.
In case of skin contact, remove contaminated clothing immediately and flush the skin with
soap and water.
In case of inhalation, remove to fresh air.
In case of ingestion, drink 2 to 4 glasses of water, induce vomiting and call a physician.
3. Obtain an OSHA/MSHA approved respirator, rubber gloves, and safety goggles.
4. If there is a spill, absorb the spilled liquid with vermiculite, dry sand or similar material.
5. Obtain a container that can be sealed securely. Carefully sweep up material into container
and seal.
6. Ventilate the area and wash the spill site after material pick up is complete. Refer to the
MSDS for disposal procedures.

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03-FEB-20
Water Cooling System
Caution!
The cooling water is heating to 65°C. Do not put fingers into the water tank. Avoid splashing of
heated water.
The system is cooled with distilled (DI) 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 inside the laser
and is connected to the reservoir filler bottleneck protruding from the rear of the laser.
To check the water level or if the system message indicates a fault code preceded by a “7”, turn OFF
the laser and allow it to cool down. Turn the filler cap counter-clockwise to remove. Inspect the water
level by looking into the reservoir filler bottleneck. Fill with DI water until the water fills up to within ½
to 1 inch from the top of the reservoir filler bottleneck and install the filler cap back on. Turn on the
laser and allow operation for 15 seconds then turn the system OFF. Remove the filler cap to check
the water level and refill with more DI water if needed. Repeat the procedure until the water reservoir
is filled within ½ to 1 inch from the top of the bottleneck. After the reservoir is completely refilled,
restart the laser system and allow the system to warm up.
Display Monitor
Display Monitor Care and Cleaning
Always handle the display monitor with care. It is recommended to periodically clean the glass touch-
screen surface:
● Use isopropyl alcohol or a non-abrasive glass cleaner. Avoid using cleaners other than glass
cleaners. Do not use any vinegar-based solutions.
● Apply the cleaner with a soft cloth. Avoid using gritty cloths.
● Always dampen the cloth and then clean the screen.

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03-FEB-20
User Verification Tests
Warning!
ALWAYS PERFORM USER VERIFICATION TESTS AS OUTLINED IN THIS SECTION AT THE
START OF EACH TREATMENT DAY AND WHEN THE HANDPIECE IS CHANGED. CHECK THE
DELIVERY SYSTEM FOR ANY DAMAGE (I.E.: DROPPED). DISCONTINUE USE OF YOUR LASER
DELIVERY SYSTEM IF YOU SUSPECT A PROBLEM.
Overview of Tests
This section contains information regarding three tests. Each test should be performed for the
indicated handpieces at the beginning of each treatment 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. 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, Candela P/N 1301-00-8291 (included in the accessory kit
supplied with the laser).
● Vbeam Prima 15 mm distance gauge
● White paper
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 Bubble Detector: Verifies that bubbles in the cryogen line are detected and the
associated “fault” message is displayed on the system.
4. Beam Alignment: Verifies that the laser and aiming beam are in alignment with the distance
gauge.

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03-FEB-20
Test 1: Cryogen Alignment
Purpose: To verify the cryogen spray nozzle is properly aligned with the distance gauge ring.
Procedure:
1. Put the laser with the delivery system installed in STANDBY. Caution- laser should remain
in STANDBY mode for the duration of the test.
2. Press the Cooling button to select the Medium DCD setting.
3. Install Vbeam Prima 15 mm distance gauge.
4. Point handpiece away from objects and personnel (toward the floor). View the contact ring of
the distance gauge, looking from the handpiece.
5. Press and release the 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. Please see
below the “Acceptable” and “Unacceptable” pictures.
Acceptable:
No mist on contact ring
No Cryogen clipping
on Distance Gauge
Figure 58: Cryogen Alignment (1)

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03-FEB-20
Acceptable:
Small amount of mist on contact
Small Cryogen
clipping on distance
gauge
Unacceptable results:
Excess mist on contact ring
Cryogen clipping
on distance gauge

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03-FEB-20
Results
● Acceptable alignment – no further action needed.
● Unacceptable alignment – repeat the test with a different distance gauge.
Repeat Test results

● If the tests show acceptable alignment with the new distance gauge, contact Candela
Technical Support to review results.
● If the result is still “unacceptable”, try a different handpiece (if available) or contact Candela
Technical Support.
Test 2: Cryogen Coverage

Purpose: To verify the proper spray duration required to fill the distance gauge ring. (Note: Distance
gauge ring is larger than the spot size marking).
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.
Procedure:
1. Put on appropriate laser safety glasses.
2. Put the laser in STANDBY. Caution – laser should remain in STANDBY mode for the
duration of the test.
3. Install 15 mm distance gauge.
4. Press the Cooling button to select the Medium DCD setting.
5. Place the distance gauge over the 15 mm distance gauge spot on the template (Candela
P/N 1301-00-8291).
6. Press and release the Purge button
7. Remove handpiece QUICKLY from template.
8. 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.
Caution!
Periodically check that the cryogen sprays through the center and fills the distance gauge ring
area to maintain proper coverage.

Laser System
03-FEB-20
Test 3: Cryogen Bubble Detection
Purpose: To ensure that bubbles in the cryogen line are detected and the associated “fault”
message is displayed on the 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 ALL OTHER DELIVERY SYSTEM CONNECTORS INSTALLED, disconnect the
Cryogen Connector (see Figure 54).
4. Install the 15 mm distance gauge into the handpiece and install the handpiece into the
Verification Port.
5. Press the Cooling Menu button to enter the Cooling Spray Settings Window and set the DCD
spray to 100 ms and the delay to 20 ms.
6. Set the FLUENCE to the lowest setting.
7. Enter READY mode and calibrate the laser by pressing on the footswitch.
8. Aim the handpiece in a direction away from personnel (such as the floor).
9. Depress the footswitch to pulse the laser continuously until a PURGE REQUIRED window
box appears on the user screen and lasing ceases. This should happen in less than 50
pulses.
10. Reconnect the Cryogen Connector (see Figure 8). Press “PURGE” may be required until the
line is refilled.
Test 4: Beam Alignment

Purpose: This procedure is designed to help identify a misaligned distance gauge on your
delivery system. This test also verifies that the aiming laser beam is working properly.
Procedure:
1. Put on appropriate laser safety glasses. Warning – laser will enter READY mode for the
duration of the test.
2. Install the desired distance gauge spot size for your laser treatment.
3. Press the READY button (if in STANDBY) on the Treatment screen. Do not press the
fingerswitch or the footswitch to pulse the laser. Aim the handpiece at a white piece of
paper and inspect the aiming laser beam for circular uniformity and clarity. If the
aiming beam spot is not uniform, press the STANDBY button to set the laser to
STANDBY mode. Check for distance gauge interference. Fix or clean the distance
gauge per Section 5 of this manual or replace if correct results cannot be achieved.
Repeat Beam Alignment test until satisfactory results are achieved.

Laser System
03-FEB-20
Note
Always repeat this procedure for each distance gauge prior to use.
Important!
Discontinue use of the laser system if the aiming beam is not present! This may be an indication of a
broken fiber optic. Replace the delivery system and perform the Beam Alignment Test to see if this
corrects the problem. If this does not fix the problem, contact Customer Service.
Warnings Related to the Delivery System

The fact that your laser delivery system passes the applicable tests contained in this section does not
guarantee that your laser delivery system is problem-free. Discontinue use of your laser delivery
system if you suspect a problem with it.
Use of a delivery system/handpiece with problems could result in adverse effects such as burns,
scarring (hypertrophic and/or atrophic) and/or hyperpigmentation/hypopigmentation.
● Do not use a dropped delivery system/handpiece until after testing.
● Dropping the delivery system can result in damage and can affect the life of the delivery
system, calibration, cryogen spray alignment, or bubble sense detection resulting in possible
patient burns. If the delivery system is dropped the user tests must be performed before
use.
● Note: The laser beam alignment can be altered: 1) by dropping a delivery system/related
component or 2) by the laser beam passing through a burn spot or pits on the optics. A laser
beam that is altered or misdirected could result in heating, charring and possible ignition of
associated components along with possible user and patient burns. Purge faults could
indicate an excessive heating problem.
● Do not use a handpiece if cryogen is not aligned with the delivered energy spot
/aiming beam or the cryogen spray pattern is unusual. If this is noted contact Candela
Technical Support and discontinue use of the handpiece.
● Do not use a handpiece if cryogen is found to be leaking from the hand piece nozzle
tip or a reduced cryogen flow is noted. Discontinue use until the cause is determined and
eliminated. Purge the lines to flush the valve. If problem persists, do not use. Contact
Candela technical support.

Laser System
03-FEB-20
Treatment Related Warnings
● Tilting the distance gauge can result in an elliptical energy spot verses a circular spot and affect
the distribution pattern of the cryogen. The distance gauge must be held perpendicular to the
treatment spot. Crescent burns on the patient may occur.
● Overlapping of treatment spot size areas may result in crescent and general patient burns.
● Selecting too short of cryogen spray duration for a given spot size may result in patient burns and
other adverse effects.
● Failure to replace the cryogen canister when the “replace canister” message appears could result
in patient burns.
● Failure to keep fiber tips and slider optics free of dust and debris can lead to possible
patient burns.
 Laser energy striking dust and debris on optics including fiber tips will damage them which
could lead to possible patient burns. When components of the delivery system are not
attached to the laser system, such as the proximal end connector, cover to prevent dust and
debris from collecting on optics and exposed fiber tips.
● Failure to keep windows at optimum may result in patient burns.
 Follow product’s delivery system cleaning protocols.
 Replace/clean windows according to protocol in Section 5 of this manual.
● Failure to replace windows properly after cleaning can result in failure of the lens or
window and may cause patient burns.
 Improper window insertion could result in lens or window failure and cause burns.
 When removing a window for cleaning, carefully note the window surface that was exposed
to debris and the direction in which such window surface faces. When re-inserting the
window, ensure that the window surface that was exposed to debris faces the same direction
as it did prior to removal.

Laser System
03-FEB-20
Troubleshooting
These troubleshooting solutions do not replace the instructions or procedures given in this button.
Review all instructions and procedures in this button before performing the following troubleshooting
solutions.
General Laser System Troubleshooting Solutions

Situation /
Probable Cause or Indicator Solution
Symptom
Reseat the power cable and check the
The power is not connected properly.
circuit breaker.
The laser system circuit breaker is in Switch the circuit breaker to the “ON”
The System the “OFF” position. position
cannot be The key-lock switch was not fully Turn the key-lock switch fully clockwise
turned on. engaged. to the “Start” position and release.
Check the remote interlock connection.
The external interlock is open. If connected to a door, make sure the
door is closed.
Laser pulses,
The DCD Spray settings are set to zero Select the DCD Spray “up arrow” button
no cryogen is
“0”. to increase the spray setting
delivered
Remove the cryogen canister or
Cryogen leak Tubing breaks in the delivery system. disconnect the handpiece assembly
from the laser. Call Service.
Warm-up Time
The water or cryogen temperature
has exceeded Call Customer Service.
control circuitry failed.
60 minutes
Ineffective
fluence System or fiber has degraded. Call Customer Service.
response
Replace Replace the cryogen canister with a
Canister There is insufficient cryogen in the new canister supplied by Candela and
Message canister. press the DCD Counter and Reset
Appears Button (See Section 5).
Press the purge button until problem
resolves. This must be done with the
Purge Bubbles have been detected in the
handpiece outside of the calibration
Required cryogen line.
port. If the problem persists, call
Service.
Laser will not
enter READY Trigger Switch is pressed. Deactivate the Trigger Switch.
mode
Aiming beam  Damaged or broken fiber.
 Replace delivery system.
missing in  Bad aiming beam laser or driver
READY mode  Or Call Technical Support.
circuit.

Laser System
03-FEB-20
Situation /
Probable Cause or Indicator Solution
Symptom
 Intensity set too low.  Set aiming beam intensity using
Aiming beam  Dirty distance gauge windows. button provided.
appears dim  Dirty or damaged slider optics.  Clean or replace windows.
 Failing aiming laser.  Or Call Technical Support.
Aiming beam  Clean or replace windows.
 Dirty distance gauge windows.
appears non-  Replace distance gauge.
uniform  Dirty or damaged slider optics.
 Replace delivery system.

Laser System
03-FEB-20
Fault and Warning Messages
A fault message typically occurs due to a system malfunction. Sometimes clearing the fault and
retrying the previous operation can be successfully accomplished without further faults occurring. If
the fault message persists, call Technical Support and report the Fault Number. Fault processing
automatically places the system into STANDBY mode. The following conditions occur outside of
normal system operation. When the system enters a fault condition, it beeps and displays a warning
or fault message. These solutions do not replace the instructions or procedures given in this button.
Review all instructions and procedures in this button before performing the following troubleshooting
solutions.
Troubleshooting Solutions for Fault and Warning Messages
Message Fault # Probable Cause Corrective Actions
Put laser in STANDBY.

 Check DCD spray settings to make
sure it is “ON”.
 Press the Purge button to purge air
bubbles out of the handpiece.
Handpiece Bubble Circuit
1.1  Check DCD Canister and make sure
Test Failure.
it is full and replace if needed. If the
canister is full, try reinstalling or
replacing the canister.
Fault 1 – Bubble  Replace with a new or spare
Detect Circuit delivery system.
Fault  Check DCD spray settings to make
sure it is “ON”.
 Press the Purge button to purge air
bubbles out of the handpiece.
Canister Bubble Circuit  Check DCD Canister and make sure
1.2
Test Failure. it is full and replace if needed. If the
canister is full, try replacing or
reinstalling the canister.
 Replace with a new or spare
delivery system.
 Go to STANDBY then try to calibrate
Shutter isn’t in correct laser.
position when checked or
Fault 3- Shutter  Restart the laser and recalibrate
3.1 does not respond to
Fault laser.
actuation to correct
position. Call Candela Technical Support if
problem persists.
Turn OFF laser for at least 5 seconds.
Fault 4 – High Voltage Power
Restart and calibrate laser. If persistent
4.2 Supply Communications
HVPS Fault messages appear, call Candela
Time-out.
Technical Support.

Laser System
03-FEB-20
Turn OFF laser for at least 5 seconds.

High voltage power Restart and calibrate laser. If persistent
5.1
supply tolerance fault. messages appear, call Candela
Fault 5 – Technical Support.
HV Tolerance
Fault Turn OFF laser for at least 5 seconds.
High voltage power Restart and calibrate laser. If persistent
5.2
supply charge time-out. messages appear, call Candela
Technical Support.
Laser failed to complete
calibration to desired
fluence within 20 pulses. Recalibrate laser after each step in the
 Damaged or dirty order given below until a successful
windows and/or dist. calibration is achieved:
gauge lenses. 1. Put laser in STANDBY. Check,
 Laser mobility shocks clean and/or replace distance gauge
may have shifted the windows.
laser head out of 2. Clean or replace handpiece window
Fault 6- alignment.
6.2
Calibration Fault 3. Change fluence by two settings up
 Worn delivery system or lower.
components.
4. Try a different distance gauge.
 Aging laser dye
solution, dye 5. If available, install a spare delivery
cartridge, fluid system.
system and/or laser If problem persists, contact Candela
head components. Technical Support.
 Low power input or
output.

Laser System
03-FEB-20
Go to STANDBY and allow sufficient

time for laser to warm-up. Verify that the
laser room environment and
DI water under- temperature meet all requirements per
7.1
temperature. Section 2 of this button. Verify that the
water level is correct. If fault message is
persistent, contact Candela Technical
Support.
Turn OFF laser and allow sufficient time
for it to cool down. Verify that the laser
room environment and temperature
DI water over-
7.2 meet all requirements per Section 2 of
temperature.
this button. Verify that the water level is
correct. If fault message persists,
contact Candela Technical Support.
Fault 7 – DI Water Pump Pressure
Deionized (DI) Fault. Low or no DI water Turn laser OFF.
Water System pressure and/or flow.
 Check DI water level (the base of
Fault  DI water system the reservoir filler bottleneck should
pressure switch does be filled with DI water). Refill
not change when reservoir if needed.
power turned on.
 Check for DI water leaks underneath
7.3  DI water pump is not the laser. If water leak is present,
ON, or DI pressure call Service.
switch is not
actuated.  Restart and turn OFF laser 2-3
times to allow fluid system to pump
 DI water level is low water and flush out air bubbles.
and/or there are air
bubbles flowing If problem persists, contact Candela
through the fluid Technical Support.
system.
Temperature Sensor
7.4 Fault (sensor circuit open Contact Candela Technical Support.
or shorted).

Laser System
03-FEB-20
Low DCD pressure.

 Cryogen Canister
may be empty
 Bubbles need to be
purged out of new  Remove and reinstall DCD canister.
canister  Install a new canister.
8.1  Flow of cryogen may
be obstructed If fault persists, contact Candela
 Overheated delivery Technical Support
system or DCD
canister
 DCD Settings may be
out of range.
Fault 8 – High DCD pressure.
DCD System  Bubbles need to be  Shut down laser and allow cooling.
Fault purged out of new Check room temperature and open
canister DCD and Storage Compartment lid
 Flow of cryogen may to allow ventilation. Restart laser.
8.2 be obstructed  Install a new canister.
 Overheated delivery
system or DCD
canister If fault persists, contact Candela
Technical Support.
 DCD Settings may be
out of range.
Reinstall or replace the delivery system.
8.3 DCD Valve Fault If problem persists, contact Candela
Technical Support.
DCD Temperature
8.4 Contact Candela Technical Support.
Sensor Fault
DI water temperature not
9.1 in normal range after 60 Contact Candela Technical Support.
Fault 9 – minutes.
Warm-Up
Timeout DCD pressure not in
9.2 normal range after 60 Contact Candela Technical Support.
minutes.

Laser System
03-FEB-20
Reinstall Distance Gauge; or insert a

spare distance gauge; or rotate the
Unrecognized distance distance gauge 180° and re-insert into
10.1 gauge while in READY the handpiece. Calibrate the laser.
mode.
If problem persists, call Candela
Technical Support.
Remove delivery system. Reinstall
Handpiece disconnected delivery system and calibrate laser.
10.2
while in READY mode. If problem persists, contact Candela
Technical Support.
Reinstall Distance Gauge; or insert a
Distance Gauge spare distance gauge; or rotate the
Fault 10 – 10.3 disconnected while in distance gauge 180° and re-insert into
Delivery System READY St mode ate. the handpiece. Calibrate the laser.
Fault
If problem persists, call Candela
Technical Support.
 Remove delivery system and
reinstall. Calibrate laser.
 Replace delivery system with a
Fiber not detected while
10.4 spare or new delivery system.
in READY mode.
Calibrate laser.
If fault persists, contact Candela
Technical Support.
The system or handpiece does not
Distance Gauge not
10.5 support the installed distance gauge.
supported.
Install a spot size that is supported.
Wavelength out of range.
Fault 11-  Dye solution may
need wavelength
Wavelength 11 Contact Candela Technical Support.
adjustment.
Fault
 Dye solution may
need to be replaced.
Laser head energy of last Try to recalibrate the laser system.
12.1
treatment pulse was low. Contact Candela Technical Support.
Laser head energy of last Try to recalibrate the laser system.
12.2
treatment pulse was high. Contact Candela Technical Support.
Laser head energy of last
Fault 12 –
treatment pulse was Try to recalibrate the laser system.
Energy Out-of- 12.3
greater than maximum Contact Candela Technical Support.
Range Fault
allowed.
Laser head energy not Try to recalibrate the laser system.
12.4
balanced. Contact Candela Technical Support.
Laser head energy Try to recalibrate the laser system.
12.5
detector malfunction. Contact Candela Technical Support.

Laser System
03-FEB-20
Fault 13 –
Redundant trigger switch
Trigger Switch 13 Contact Candela Technical Support.
fault.
Fault
Fault 14 –
14 Simmer Circuit fault. Contact Candela Technical Support.
Simmer Fault
Recalibrate laser after each step in the
order given below until a successful
calibration is achieved:
Low Transmission: 1. Clean and/or replace windows in
 Dirty windows in distance gauge and/or handpiece.
distance gauge 2. Try another distance gauge (the
and/or handpiece. same size if available). If this
 Damaged lenses in distance gauge works, contact
15.1 distance gauge. Customer Service to replace bad
 Incorrect windows one.
were installed. 3. Verify that there is one flat on the
 Worn delivery window edge and/or replace the
system. window (Vbeam Prima windows
Fault 15 – only).
Transmission 4. Replace the delivery system.
Fault
If problem cannot be fixed, call Candela
Technical Support.
Recalibrate laser after each step in the
order given below until a successful
calibration is achieved:
High Transmission:
1. Verify that the distance gauge has
 Windows missing. both windows (input and output) and
15.2  3mm or 5mm that the handpiece has a window.
distance gauges only: 2. If problem persists for 3mm and
Worn filter in 3mm or 5mm distance gauge, replace 3mm
5mm distance gauge. or 5mm distance gauge.
Contact Candela Technical Support if
problem persists.
Displays if canister
bubble is detected in
 Press Purge button to purge
READY and DCD is
bubbles out of cryogen line
enabled.
 Check canister to see if it is empty.
 Bubbles need to be
Fault 16 – Replace if needed.
16 purged out of new
Replace Canister canister.  If the canister is full, take it out and
reinstall then press Purge button.
 Cryogen Canister
may be empty. If problem persists, contact Candela
Technical Support.
 Flow of cryogen may
be obstructed.

Laser System
03-FEB-20
Bubbles detected in
handpiece:
 Press Purge button to purge
 Air bubbles need to bubbles out of cryogen line.
be purged out of
cryogen fluid lines.  Check canister to see if it is empty.
Fault 17 – Replace if needed.
17  Cryogen Canister
Purge Required may be empty.  If canister is full, take it out and
reinstall then press Purge button.
 Cryogen line may be
obstructed. If problem persists, contact Candela
Technical Support.
 Overheated delivery
system.
Energy Circuit Calibration
Fault.
Fault 18 – Circuit DI Circuit Calibration
Calibration Fault Fault.
DCD Circuit Calibration
Fault.
19.1 Laser Trigger Fault. Contact Candela Technical Support.
Fault 19 – 19.3 Laser Timer Fault. Contact Candela Technical Support.
Laser Fault 19.4 Laser Head Power Fault. Contact Candela Technical Support.
19.5 High Voltage Dump Fault. Contact Candela Technical Support.
Turn OFF laser and contact Candela
20.1 Dye Pump Fault.
Technical Support.
Dye cartridge top cover
Fault 20 – may not be fully or Turn OFF laser and contact Candela
20.2
Dye System properly installed in Technical Support.
Fault place.
No Dye Cartridge Turn OFF laser and contact Candela

20.3
present. Technical Support.
Fault 21 – Contact Candela Technical Support.

Code Update did not
Code Update 21
complete properly.
Fault
Fault 22 – Contact Candela Technical Support.
Processor internal
Processor 22
communications Fault.
Comm. Fault
Fault 23-
Device Communications
Device Comm. 23 Contact Candela Technical Support.
Fault.
Faults
Triplet Quencher addition
Fault 24- 24.2 Contact Candela Technical Support.
exceeded its limits.
Triplet Quencher
Fault Triplet Quencher Pump
Fault.

Laser System
03-FEB-20
Section 7: Labels and Symbols
The Vbeam Prima laser 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. Refer to
Figure 61.
# Label / Symbol Description
1 CAUTION: Consult accompanying documents.
Protected by one or more

U.S. Patent(s):
2 5,599,342; 6,514,244; U.S. patents that may cover the laser system.
5,814,040; 6,171,301
2157-40-8623 REV [ ]
Laser emission characteristics and classification per the

3
IEC/EN standards.
Location of the footswitch control tube connection on the

4
rear of the laser system.
WARNING: HIGH VOLTAGE (located on electrical

5
components under the protective covers).
Location of the remote interlock circuit that connects to

the laser treatment room door switch to shut down the
6
laser system should a person enter the laser treatment
room during laser emission.
Reservoir is filled with distilled or deionized water and

7
should be kept full.
8 Location of the USB software ports.
8501-00-9080, Revision F Page 100

Laser System
03-FEB-20
CAUTION: Class 4 visible and invisible radiation

when open. Avoid eye or skin exposure to direct or
2157-40-8623 REV [ ]
scattered radiation.
CLASS 4 VISIBLEAND INVISIBLE
9 RADIATION WHEN OPEN.
AVOID EYE OR SKIN EXPOSURE
Protective panel encloses a Class 4 laser energy

TO DIRECT OR
SCATTERED RADIATION.
source.
10 Laser energy emission port.
11 Laser energy emission port.
CAUTION: To reduce the risk of shock, do not

12 remove covers. Refer servicing to qualified service
personnel.
Selected requirements under CDRH 21 CFR 1040.10

13 & 1040.11 were waived for comparable IEC
requirements as allowed by Laser Notice 50.
The delivery system is equipped with a "Type BF"

14
applied part in accordance with IEC/EN 60601-1.
The “snowflake” indicates the location for inserting

the DCD Cryogen Canister.
15 Candela GentleCool 1000-gram Cryogen Canisters
(Candela P/N 1600-00-0210) should be used on this
Vbeam Prima Laser System. Also, refer to Cryogen
MSDS 8501-00-1701 for additional information.
16 Hot surface when laser system is on. Do not touch.
8501-00-9080, Revision F Page 101

Laser System
03-FEB-20
Refer to the system operator's manual for complete

17
information on safe operation.
18 System Nameplate
CANDE L A CO RP O RAT I O N
19 The laser system is approved to CSA standards.

F i l e Nu m b e r :7 0 0 8 9 4 6 8
Co n tr a c t Nu m b e r :2 6 1 0 8 1
CAUTION: Tip hazard when transporting the

20
system.
21 Fiber-optic connector
STOP
22 Emergency Stop Switch
In the USA: Federal law restricts this device to sale

23
by or on the order of a physician.
8501-00-9080, Revision F Page 102

Laser System
03-FEB-20
The following illustration shows the rear and top panels of the Vbeam Prima system and the locations
of the labels described in the previous pages. The label numbers in the illustration correlate to the
label numbers in the description tables.
23
22
Figure 61: Label Locations on the Vbeam Prima System
8501-00-9080, Revision F Page 103

Laser System
03-FEB-20
Section 8: Laser Accessories and Replacement Parts
Vbeam Prima Laser System Accessories and Part Numbers

Description Quantity Part Number
Operator’s Manual 1 8501-00-9080
Quick Reference Guide 1 8501-00-0391
USB – Operator’s Manual and Treatment Guidelines 1 4805-00-0106
Wall Sign 1 2157-40-8716
Fiber Support Pole 1 7123-00-0508
Holster Kit 1 7123-00-0524
Fiber Receptacle Window Kit 1 7123-00-0616
DCD Delivery System 1 7123-00-0433
Contact Cooling Handpiece Window Kit 1 7123-00-0617
CC Delivery System 1 7123-00-0431
DCD Distance Gauge Kit 1 7123-00-0521
DCD Handpiece and Distance Gauge Window Kit 1 7123-00-0615
DCD HP Window Extractor Tool 1 7123-00-0494
DCD Distance Gauge; 1.5 mm 1 7123-00-0567
DCD Distance Gauge; 3 – 7 mm 1 7123-00-0374
DCD Distance Gauge; 3x10 mm 1 7123-00-0478
Footswitch 1 5103-00-0030
Physician Eyewear 1 8095-00-0489
Patient Eyewear (Goggles) 1 8095-00-0470
Cryogen Release Valve 1 3430-02-0010
Ultrasound Gel, ¼ L 1 MT70360
8501-00-9080, Revision F Page 104

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Laser System

EC Authorized Representative in the European Community

Manufactured by: Candela Corporation

Section 2: Hazards, Precautions and Safety Features 13

8501-00-9080, Revision F Page i

Section 3: Operating Instructions 27

8501-00-9080, Revision F Page ii

Section 4: Clinical Guide 59

Section 5: Laser System Start-Up 62

Section 6: Maintenance, Troubleshooting and Delivery System Verification Tests 66

8501-00-9080, Revision F Page iii

Section 7: Labels and Symbols 100

Section 8: Laser Accessories and Replacement Parts 104

8501-00-9080, Revision F Page iv

Laser System P/N # Configuration

8501-00-9080, Revision F Page 1

Figure 1: Vbeam Prima – Front View

8501-00-9080, Revision F Page 2

Figure 2: Vbeam Prima – Rear View

8501-00-9080, Revision F Page 3

DCD Delivery System Handpiece

8501-00-9080, Revision F Page 4

Figure 4: EverCool Delivery System Handpiece

Tips and Distance Gauges

DCD Delivery System Smart Gauges

8501-00-9080, Revision F Page 5

Figure 5: Fiber Support Pole Assembly

8501-00-9080, Revision F Page 6

Vbeam Prima Laser System Specifications

Parameter Specified Value

Fiber Delivery Systems ● Minimum bend radius: 6.0” / 15 cm

8501-00-9080, Revision F Page 7

8501-00-9080, Revision F Page 8

Type of protection against electric shock Class I equipment

8501-00-9080, Revision F Page 9

Figure 6: Service Panel

8501-00-9080, Revision F Page 10

8501-00-9080, Revision F Page 11

Transportation and Storage

8501-00-9080, Revision F Page 12

Laser Room Precautions

Flash Fire Hazards

8501-00-9080, Revision F Page 13

Nominal Ocular Hazard Distance (NOHD)

8501-00-9080, Revision F Page 14

8501-00-9080, Revision F Page 15

Optical Safety Precautions

Electrical and Mechanical Hazards

High Voltage Electrical Hazard

8501-00-9080, Revision F Page 16

Laser Mobility Care and Wheel Locks

8501-00-9080, Revision F Page 17

Important Note to Physicians

8501-00-9080, Revision F Page 18

For specific customer situations, contact Candela Technical Support.

Laser Fiber Fire Hazard

8501-00-9080, Revision F Page 19

NIOSH Hazard Controls

8501-00-9080, Revision F Page 20

100% Drop for

8501-00-9080, Revision F Page 21

Portable and mobile communications

3 V/m Where P is the max power in watts