Vbeam Perfecta, Platinum and Aesthetica Operators Manual Rev D June 2014

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 to 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. (EC Authorized Representative) Scanlan Group B.V. Aalsmeerderweg 610 1437 EJ Schiphol-Rozenburg The Netherlands Phone: +31(0) 20 653 0553 Fax: +31(0) 20 653 3053 Candela Corporation 530 Boston Post Road Wayland, MA 01778-1886 Telephone (508) 358-7637 Toll Free (800) 733-8550 (Technical Assistance) Toll Free (800) 73-LASER (Customer Service)

Table of Contents Section 1: The Vbeam Laser System ... 1 Applications... 1 Descriptions ... 2 System Specifications ... 6 Electrical Requirements ... 7 Environmental Requirements ... 9 Section 2: Hazards, Precautions and Safety Features ... 11 Laser Room Precautions... 11 Flash Fire Hazards ... 11 Optical Precautions ... 12 Electrical and Mechanical Hazards ... 13 Chemical Hazards ... 14 Fire Hazards ... 16 Laser Generated Air Contaminants (LGAC)... 17 Electromagnetic Interference ... 17 Safety Features... 21 Environmental Protection: ... 22 Disposal Hazards and Guidance... 22 Section 3: System Operation Features ... 25 Control Panel ... 25 System Status Indicator ... 28 System Settings ... 30 Operating Parameters ... 32 Other Controls ... 40 Section 4: Laser System Start-Up ... 42 Laser System Start-Up Procedure ... 43 Section 5: Calibrate Procedure ... 46 Laser Calibration Procedure ... 47 Section 6: Maintenance, Troubleshooting and Delivery System User Verification Tests ... 51 Laser Software and System Upgrades ... 51 Fiber-Optic Delivery System ... 52 Windows and Lens ... 52 Cleaning and Disinfection ... 54 Handpiece Delivery System Replacement ... 61 Cryogen Canister ... 63 Laser MegaDye Cartridge and Dye Change Kit ... 64 Water Cooling System ... 65 Touch Screen... 66 User Verification Tests ... 66 Troubleshooting ... 73 Fault and Warning Messages ... 75 Section 7: Labels and Symbols ... 83 General Label/Symbol ... 83 Mains Switch (or Circuit Breaker) Symbols ... 83 8501-00-1780, Revision D

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Key-lock Switch Symbols ... 84 Laser System State Status Symbols ... 84 Laser System Labels and Symbols ... 85 Label Locations ... 89 Section 8: Laser System Packing Lists, Accessories and Replacement Parts ... 91 Packing Lists ... 91 Replacement or Spare Parts ... 94 Section 9: Service Internal Calibration Procedure ... 95 Calibration Schedule ... 95 Internal Calibration ... 96

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Section 1: The Vbeam Laser System Applications This Operator’s Manual provides operation instructions for the Vbeam laser system with all available spot sizes. The spot sizes included in your laser system depends on which options were purchased. The following table lists all available spot sizes for the Vbeam laser systems.

Table 1.1: Vbeam Laser System Configurations Laser System Configuration

Spot Sizes (mm)

7 and 10 mm Smart Gauges 7 and 10 mm PL Distance Gauges 3, 5, 7, 10, 12 and 3x10 mm Smart Gauges

3, 5, 7, 10, 12 and 3x10 mm Smart Gauges 7 and 10 mm PL Distance Gauges The Vbeam laser system is a flashlamp-excited pulsed dye laser in the Candela Family of Pulsed Dye Laser Systems indicated for dermatological applications. The Vbeam delivers pulses of laser energy at a wavelength of 595 nanometers (nm) that passes through the dermis and epidermis skin layers and is absorbed by the hemoglobin in the blood vessels rather than by the surrounding tissue. The absorbed laser energy is converted into heat, causing coagulation of the target vessels, which are not subsequently regenerated. The pulse duration used is 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 in order 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). Vbeam dermatological applications include the treatment of benign cutaneous vascular lesions, benign vascular gynecological lesions and periorbital wrinkles. For instructions on the specific applications and treatment parameters for each indication, refer to the Candela Treatment Guidelines for the Vbeam Laser System (Candela Document Part Number (P/N) 8502-00-0891).

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Descriptions The Vbeam Pulsed Dye Laser System (Figure 1.1 and 1.2) is a pulsed, flashlamp-excited dye medical laser controlled by two separate processors. One processor is used to control the Graphical User Interface (GUI) and the other is used to control the laser I/O functionality. The user interface is an LCD panel with a touch screen overlay. This allows the operator to select the laser operating parameters, initiate an automatic calibration procedure and select DCD parameters.

The Laser System The Vbeam 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 a number of exposures to the flashlamp energy, the dye becomes degraded and the dye cartridge must be replaced. The Vbeam laser also includes the unique MegaDye Cartridge that enables the system to deliver many thousands of pulses before requiring dye replacement. 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 calibration port is located centrally on the front of the laser. This port is used to calibrate the output 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.

Figure 1.1: The Laser System

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The output of the laser is delivered through an optical fiber coupled to a removable distance gauge. The distance gauge contains the internal focal lenses and a protruding distance gauge ring. The distance gauge ring is placed against the skin to ensure proper focusing and spot placement on the treatment area. A trigger-switch (finger-switch or footswitch) controls the delivery of the pulses.

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The user selects the desired energy density (fluence) level and enables or disables the laser at the control panel. The laser delivers pulses at a repetition rate of up to 1.5 pulses per second depending on the fluence, pulse duration, repetition rate and spot size setting. The laser system is equipped with interlocks that will disable the laser emissions if the remote interlock circuit is open or when the MegaDye Cartridge Top Cover or the fiber is removed. A green aiming beam is provided to illuminate the treatment area. The aiming beam and treatment beam are dimensionally identical, so the aiming beam can be used to accurately define the treatment pulse location. The aiming beam is illuminated when the laser enters the Ready State.

Figure 1.2: Rear of the Laser System

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 (Figure 1.1). The DCD was FDA cleared under K001589. 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 Section 6 of this Manual for cryogen canister installation, warm-up, removal and disposal instructions.

Handpiece Delivery System Each laser configuration comes with its own Delivery System and Distance Gauge Kit. The Vbeam Perfecta Laser System comes with the Perfecta Delivery System and Distance Gauge Kit that includes a Perfecta delivery system and two types of distance gauges, the Smart Gauges and the Pigmented Lesion Distance Gauges. The Platinum and Aesthetica Delivery System Kits each have their own assortment of distance gauges and a matching delivery system (See Table 1.1). Each delivery system (Figure 1.3) consists of a cable assembly and handpiece assembly. Each spot size requires a separate distance gauge to be installed in the handpiece. The cable assembly contains the fiber optic, 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 finger-switch is located on the top of the handpiece.

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Cable Assembly

Fingerswitch

The Delivery System Connectors: Fiber Optic, Cryogen Line, and Valve Control Connectors

Laser Aperture, Cryogen Spray and Distance Gauge Location

Handpiece Assembly Figure 1.3: The Handpiece Delivery System

Distance Gauges: The Smart Gauges The Smart Gauges The Vbeam Perfecta “Delivery System and Distance Gauge Kit” includes 6 aluminum distance gauges called the Smart Gauges. The distance gauge assembly contains internal focusing lenses and input/output windows to protect the lenses from dust and debris. The Smart Gauges come in 3, 5, 7, 10, 12 and 3x10 mm spot sizes. Removal and cleaning of the windows is explained in Section 6 of this Manual. Figure 1.4: The Smart Gauges

The Pigmented Lesion Distance Gauge The Pigmented Lesion Distance Gauge is designed for the treatment of benign epidermal pigmented lesions. The distance gauge (Figure 1.5) is identical to the Smart Gauges with the addition of a lens in the ring. This lens contacts the skin. The Vbeam Aesthetica and Perfecta Laser Systems include a 7mm and 10mm distance gauge. Because this lens is in constant contact with the skin, it is important to keep this lens clean for optimum performance. Cleaning instructions are provided in Section 6 of this Manual. Figure 1. 5: The Pigmented Lesion Distance Gauge

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Fiber Pole The fiber pole supports the delivery system cable as shown in Figure 1.6. This device will keep the cable suspended and reduce the weight of the delivery system during use.

The fiber pole is adjustable and can be removed from the laser system without the use of tools. The hook at the end of the fiber pole supports the fiber and helps to prevent damaging kinks or bends. The black knob located on the elbow of the fiber pole is used to lock the pivoting joints within the arm. To adjust the fiber pole, the black knob can be turned counterclockwise to loosen and move the pole to the desired position. Turn the knob clockwise to tighten and lock the fiber pole in position.

Caution! To reduce the risk of personal injury and damage to the delivery system fiber, use the Fiber Pole to support the delivery system at all times. When not in use, insert the handpiece in the Calport. 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 pole to support the delivery system, make sure there are no sharp bends in the delivery system. The Vbeam laser system contains a fiber optic cable that can be damaged if subjected to excessive bending. Never pulse the laser system if the delivery system bend radius is less than six inches or the optical fiber will be damaged. When not in use, the fiber pole can be folded for storage. Remove the fiber from the hook and turn the black knob counterclockwise to loosen all the joints. Fold the fiber pole and tighten the black knob clockwise to hold it in position. To completely remove the fiber pole assembly from the laser system, firmly pull the bottom pole out of the two grommets on the side. There is a plastic cap at the base of the pole. This cap should be reinstalled with the pole.

Locking/Swivel (Front) and Fixed (Rear) Wheels The laser is equipped with wheels. The two front wheels are capable of swiveling which makes parking in tight spaces easy. The two rear wheels are non-swiveling (fixed) wheels for direct movement of the laser (Figure 1.1). The front swivel wheels contain levers which stop the wheels from rotating. To prevent the laser from moving, the front wheels must be locked. To lock the front wheels, depress the locking lever over each of the front wheels. To release, pull up on the lever. There are no levers in place for the rear wheels.

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System Specifications The Vbeam Laser System Specifications

Table 1.2 Specifications for the Vbeam Laser System Laser Type

Flashlamp-excited, pulsed dye laser

Wavelength

595 nm

Method of Optical Output

Lens-coupled optical fiber with user selectable spot sizes.

Maximum Delivered Energy

8 Joules (J)

Accuracy of Output Energy

± 20%

Pulse Repetition Rate

Up to 1.5 Hz repetitive pulsing

Pulse Duration

0.45- 40 milliseconds

Beam Spot Sizes

3, 5, 7, 10, 12 millimeters and 3x10(elliptical)

Cooling Method

Ambient air

Dimensions

43” H x 16” W x 30” D (39” D with dye cartridge)

Weight Aiming Device

290 lbs. Class 2 Light (per EN 60825-1), 520 - 550 nm, 5.0 mW

Cryogen Voltage and Power

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HFC 134a 220 - 230 V~ , 50/60 Hz, single phase, 4,000 VA or 17.4 A at 230 V~

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Medical Electrical Equipment Standard Specifications and Classification Electromagnetic Compatibility (EMC)

Table 1.3: Compliance per IEC / EN60601-1 Type of protection against electric shock

Class I equipment

Degree of protection against electric shock offered by the applied part

Type “B”

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. The Candela Laser System is a Class II medical device per FDA 21 CFR 878.4810, and a Class 2b (Rule 9), non-invasive, active device according to Annex IX of Directive 93/42/EEC and Canadian Health Ministry 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-Z38692: Laser safety in health care facilities.

Electrical Requirements The Electrical Requirements for the Vbeam 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 twelve foot (3.7 meter) power cord terminated with a locking NEMA L6-30P plug for power connection in the United States. The installation site requires a mating NEMA L6-30R power receptacle located within ten feet (3 meters) of the intended laser system location. See Table 1.4 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 4,000 VA (See Table 1.4 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 Table 1.4 Electrical Requirements 220 V – 230 V~, 60 Hz, center-tapped, single phase, dedicated branch circuit United States with earth ground conductor capable of delivering 4000 VA of power 220 V – 230 V~ (± 10%), 50/60 Hz, single phase, dedicated branch circuit with earth Worldwide ground conductor capable of delivering 4000 VA of power. Operation of the Vbeam Laser System on a power line that is not consistently within these specifications may damage the system and will void the warranty.

Note The system may be isolated from AC mains by unplugging the power cable from the electrical service.

Figure 1.7: Replaceable Power Cable Inlet Attachment

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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 particular power plug, consult an Electrician for help. The following procedure verifies ground continuity:  Using the Ohms setting of a Volt-Ohm meter, set the scale to “x1”. Measure the resistance between the plug’s ground pin and any unpainted conductive surface on the laser chassis. This reading must fall between 0 – 0.1 Ohms.  A battery 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 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 Pulsed Dye Laser System. Reference document: Vbeam Service Manual (P/N # 8501-00-1795).

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.

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

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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 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 the front of the laser (place the Delivery System into its original box for transportation if necessary). A handle located on the top cover behind the front panel 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.

Warning! DO NOT USE THE FIBER POLE OR REAR DYE CARTRIDGE PLATFORM/BUMPER BAR (FIGURE 1.2 AND 1.6) AS HANDLES TO LIFT OR MOVE THE LASER SYSTEM. THEY WERE NOT DESIGNED TO BE USED AS HANDLES TO SUSTAIN THE WEIGHT OF THE LASER FOR RELOCATING. 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 laser system is not designed for mobile use.

Transport and Storage For transport and storage of the Vbeam Laser system, the temperature must be kept between 40° and 110° F (5° and 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. IF THE LASER IS EXPOSED TO TEMPERATURE BELOW 5°C, 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 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 oxygenenriched 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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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 ≥ 5.2 BETWEEN 592 AND 596 NANOMETERS (NM). The laser beam emitted by the Vbeam Laser System is capable of causing loss of vision. The laser operates at 595 nm, which falls within the visible spectrum. The cornea and lens of the eye are transparent to visible light. Any energy emitted by the Vbeam 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 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 Laser System must wear appropriate eye protection available from Candela.

Table 2.1: Vision Hazards Vbeam Laser NOHD Zone Beam Divergence Full Spot Diameter, mm NOHD, meters Angle (radians) 3

0.064

125.3

5

0.063

184.2

7

0.100

129.7

7PL*

0.087

132.8

10

0.161

78.9

10PL*

0.141

90.5

12

0.198

65.7

3 x 10

0.095

122.6

*PL = Pigmented Lesion Distance Gauge

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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 Laser System is not in use, place it in STANDBY state to prevent accidental pulsing.  When the Vbeam Laser System is unattended, remove the key from the key-switch or 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 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 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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Fiber Optics The Vbeam 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, both front wheels must be locked. To lock the wheels, step down on the tabs on the front of the wheels. To unlock, pull up on the extending tabs. Although the Vbeam Laser System is well balanced, it weighs more than 290 pounds (almost 135 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 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 can be replaced by an authorized Candela Service Representative or the customer may perform this procedure. The triplet quencher is not accessible by the customer and must be changed by a Candela authorized Service Representative. The Dye Change Kit contains instructions for the dye cartridge replacement, MSDS info and dye kit return instructions. See Laser MegaDye Cartridge and Dye Change Kit in Section 6. 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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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. (5 x 8 ft.) – based on an 8 ft. ceiling.  Any treatment area smaller than 513 sq. ft. (but larger than 40 sq. ft.) should have a 130 CFM (cubic feet per minute) or higher fan in use during treatments with cryogen. It should be used in an exhaust mode. Since cryogen is heavier than air, it will settle toward the floor. If at all possible, have the exhaust fan 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 at all 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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Vbeam Laser System

Candela Corporation

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 2.2: Frostbite Prevention in Treatment Areas Source of Cryogen Release Direct release from cryogen canister Release from tip of handpiece (spray nozzle)

Visual outer edge of spray

Hand detection of outer edge of spray

27 inches

31 inches

19 inches

23 inches

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 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.

8501-00-1780, Revision D

CONFIDENTIAL

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