GentleLASE Operators Manual Rev A

CAUTION!

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Federal (USA) law restricts this device to sale by or on the order of a physician. Federal law also requires this device to be utilized under the direction of a physician and it should only be used by healthcare professionals authorized under state law to treat patients. All persons treating patients with this device should check to determine whether they are authorized healthcare professionals under the applicable state law. (EC Authorized Representative) Scanlan Group B.V. Tupolevlaan 32 1119 NZ Schiphol-Rijk The Netherlands Phone: +31(0)20-653-0553 Fax: 31 20-653-3053 Candela Corporation 530 Boston Post Road Wayland, MA 01778-1886 Telephone (508) 358-7637 Toll Free (800) 733-8550 (Technical Assistance) Toll Free (800) 73-LASER (Customer Service)

GentleLASE

Candela Corporation

Specifications 8501-00-1740 Revision A

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Section 1

Applications Descriptions

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GentleLASE

Candela Corporation

This manual provides operating instructions for users of the GentleLASE and GentleLASE Limited Edition (GL LE) systems. The GL LE laser system differs from the GentleLASE by only having a 12 mm delivery system and a maximum repetiti on rate of 1 Hz.

APPLICATIONS

The Candela GentleLASE system is a flashlamp-excited, alexandrite laser that may be used for hair removal and also to treat dermatological vascular lesions. Pulsed laser energy at a nominal wavelength of 755 nanometers (nm) is used in both applications. This wavelength causes maximum energy absorption by the target (lesion or hair) and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target to minimize heat transfer to surrounding tissues. Darkly colored hair responds best to treatment. 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 skin structures. The relaxation time of a target is determined by its size. According to selective photothermolysis theory, pulse durations as long as several milliseconds should be effective in hair removal. The GentleLASE may also be used to remove Spider Leg Veins. The same conditions regarding pulse duration and relaxation time described above for hair removal apply. Ideally, the wavelength selected for eradication of Spider Leg Veins is highly absorbed by the vein and only minimally absorbed by other competing chromophores in the skin. The thermal relaxation time for Spider Leg Veins is on the order of milliseconds or greater. These short pulses effectively heat the target tissue while 8501-00-1740 Revision A

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Candela Corporation

limiting injury to surrounding skin structures.

DESCRIPTIONS Laser System

The GentleLASE (Figure 1-1) is a 755nm, flashlamp excited alexandrite rod laser controlled by an embedded microprocessor. The user interface is an LCD panel with a touch screen overlay. This allows the operator to select the laser operating parameters, initiate an automatic calibration procedure and select DCD parameters. The GentleLASE system consists of an alexandrite laser head, a power supply and a coolant water circulator. The laser head contains the cavity mirrors, solid-state laser medium (chromium doped alexandrite rod), and two high-intensity xenon flashlamps that excite the laser medium. A calibration port with an internal energy meter is located in the center front of the laser. This port is used to calibrate the output of the handpiece at selected fluence levels. The laser head is cooled by the circulation of deionized water, which in turn is cooled by ambient air passing through a heat exchanger. A combination of a heater and a heat exchanger maintain the temperature of various system components within the optimum range for efficient laser operation. To provide energy to the flashlamps, a high-voltage power supply charges a storage capacitor. Then, a trigger pulse applied to the flashlamps causes the capacitor to discharge through the flashlamps. The resulting flash excites the alexandrite laser rod, causing the emission of a pulse of laser energy. The system delivers laser energy at a wavelength of 755 nm with a pulsewidth of three milliseconds. The output of the laser is delivered through an optical fiber delivery system. A replaceable distance gauge is placed against the skin to ensure proper focusing. A red aiming beam is provided to illuminate the treatment area. The aiming beam 8501-00-1740 Revision A CONFIDENTIAL Page 3

GentleLASE

Candela Corporation

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.

Dynamic Cooling Device (DCD)

The laser system can be purchased with an optional skin cooling device referred to as the dynamic cooling device (DCD). The DCD consists of an electrically controlled spray nozzle located at the treatment end of the handpiece, a cryogen reservoir canister and associated electronic control circuitry located in the top of the system enclosure. The cryogen, GentleCool™, is stored under pressure in the reservoir canister and brought to the solenoid valve via tubing. When the DCD system is on, depressing the trigger switch will cause a burst of cryogen spray to be applied to the skin prior to or after the laser pulse. Controls are provided on the laser front panel for the adjustment of the spray burst duration and for the timing delay between the spray burst and the laser pulse.

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Candela Corporation

Handpiece Delivery System

FIGURE 1.1 LASER SYSTEM

Control Panel

Independent Locking/Swivel Wheels

Laser System

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GentleLASE

Handpiece Delivery System

Locking/Swivel Wheels

Candela Corporation

Multiple handpiece delivery systems (6/8/10 mm Slider, 12/15/18 mm Slider, and for GL LE systems 12 mm only Slider) are offered with the laser system. Each delivery system (Figure 1.2) consists of a cable assembly, replaceable distance gauge and a handpiece assembly. The cable assembly contains the fiberoptic, cryogen input line and valve control wires. The handpiece assembly contains the DCD spray nozzle, safety and detection electronics, focusing lenses, and an output window to protect the lenses from dust and debris. The spray nozzle is located near the distance gauge at the treatment end of the handpiece. The GentleLASE is equipped with wheels, which both swivel and lock. All four wheels are capable of swiveling, which makes parking in tight spaces easy. The rear wheels’ swivel action may also be locked to enhance stability while transporting the GentleLASE. The front swivel wheels contain levers which stop the wheels from rotating. To lock the laser in position, 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. The rear wheels have locking levers, but these levers when depressed stop the swivel action only, and do not stop wheel rotation. To lock the swivel action of the rear wheels, depress the locking levers. To enable the swivel action, pull the locking levers up. 8501-00-1740 Revision A

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Candela Corporation

Laser Aperture & Distance Gauge Location

FIGURE 1.2 HANDPIECE DELIVERY SYSTEM

Valve Control

Handpiece Assembly

Cryogen Line

Fiberoptic

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Cable Assembly

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GentleLASE

SPECIFICATIONS

Candela Corporation

Table 1-1 Specifications for the GentleLASE laser system. Laser Type

Table 1-1 Specifications

Wavelength Method of Optical Output Maximum Delivered Energy Stability of Output Energy Stability of Output Energy (Plus Cumulative Measurement Uncertainties After Manufacture) Pulse Repetition Rate Pulse Duration Aiming Device Beam Spot Sizes (Diameter) Cooling Method Dimensions (HxWxD) Weight 8501-00-1740 Revision A

Flashlamp -excited, solid state alexandrite laser 755 nm Lens-coupled optical fiber to handpiece. 53 J ±20% ±25.4% RSS

Up to 1.5 Hz. Up to 1.0 Hz for GL LE systems. 3 msec Laser Diode, 650 nm, 5 mW 6/8/10 mm and 12/15/18 mm 12 mm only for GL LE systems. Air to water heat exchanger 35” x 16” x 28” 210 lbs (95 kg)

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Candela Corporation

Cryogen Voltage and Current

Table 1-1 Specifications Cont.

Regulatory Classifications

HFC 134a 230 V~, 50/60 Hz Worldwide 4800VA

Miscellaneous (per EN60601-1): Type of protection against electric shock Degree of protection against electric shock offered by the applied part Sterilization method Ingress protection Not “AP” or “APG” equipment

Class I equipment Type “B”

None required Ordinary enclosed

GentleLASE is a Class 4 laser product per EN60825-1 laser light hazard Classification.

GentleLASE is a Class II laser per FDA 21 CFR 878.4810, and a Class llb (Rule 9), non-invasive, active device according to Annex lX of Directive 93/42/EEC.

GentleLASE complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated July 26, 2001 8501-00-1740 Revision A

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GentleLASE

ELECTRICAL REQUIREMENTS

Candela Corporation

Table 1-2 (next page) lists Electrical Requirements for the GentleLASE. CAUTION! IF A PLUG NEEDS TO BE CHANGED, IT MUST BE DONE BY A QUALIFIED PERSON IN ACCORDANCE WITH THIS SECTION AND THE ELECTRICAL CODE OF THE INSTALLATION LOCALITY. The GentleLASE is shipped with a locking NEMA L6-30P plug for connection to 230 V~, 50/60 Hz. The installation site requires a mating NEMA L6-30R power receptacle. The power receptacle must be within twelve feet (3.5 meters) of the intended laser system location, and must be earth-grounded. The GentleLASE power connections internationally should be made with grounded, 2-conductor plug and receptacle pair. The pair must be rated for a minimum of 230V~, 30 Amp. The plug must be fitted onto the supplied line cord by an Electrician, or someone trained in electrical wiring. Once the appropriate plug is installed on GentleLASE, the ground connection must be verified prior to use in one of two ways: •

•

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 GentleLASE chassis. This reading must fall between 0 - 0.1 Ohms. A battery & light or battery and buzzer combination may be alternatively used to verify a ground connection between any unpainted conductive surface and the

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Candela Corporation

plug’s ground pin if an Ohmmeter is not available. An adequate ground connection will be indicated by illumination of the light or sounding of the buzzer. The ground integrity as described above should be checked annually. More periodic checks should be performed if the GentleLASE is moved frequently.

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

TABLE 1-2 ELECTRICAL REQUIREMENTS

Worldwide 230 V~, 50/60 Hz 21 amp maximum, 4800 VA A 30 amp dedicated branch service is recommended Maximum line-voltage variation + 10%

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GentleLASE

ENVIRONMENTAL REQUIREMENTS

Candela Corporation

Before installation of the GentleLASE, 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.

NOTE Installation of the GentleLASE system must be performed by a Candela Service Representative. Following installation, a Candela Nurse 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 GentleLASE.

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GentleLASE

Candela Corporation

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.

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. Avoid placing the laser system near heating outlets or other sources of air currents that could cause uneven cooling in the laser system.

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GentleLASE

Relocation

Candela Corporation

Care should always be taken when moving the GentleLASE. Remove the footswitch tubing from the connector (located in the rear of the laser) before moving. Guide the GentleLASE by grasping the left and right side edges of the front bezel. 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. CAUTION! TIP HAZARD! When moving the laser system, the rear wheels MUST be locked, and pointed forward and under the laser system; this will keep the laser upright. If it becomes necessary to relocate the GentleLASE, call Candela Customer Service or your distributor for details. Failure to do so may result in damage to the system, and may void any warranty.

Mobile Use Transport & Storage

The GentleLASE is not designed for mobile use.

For transport and storage of GentleLASE, the temperature must be kept between 40° and 110° F (4.5° and 43° C), and humidity between 20% and 80% (non-condensing). Ambient atmospheric pressure is suitable with no restrictions.

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Candela Corporation

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Section 2

Hazards Precautions Safety Features

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GentleLASE

LASER ROOM PRECAUTIONS

Candela Corporation

1.

Identify the laser room clearly. Post appropriate warning signs in prominent locations at all entrances to the laser room.

2.

Cover all windows, portholes, etc. with opaque material to prevent unintended viewing or laser light escaping from the laser room.

3.

When the GentleLASE is in operation, restrict entry and limit access to the laser room to those personnel both essential to the procedure and well trained in laser safety precautions.

4.

Make sure that all laser room personnel are familiar with the laser system controls and know how to shut down the laser system instantly in an emergency.

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Candela Corporation

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 SO LVENTS 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: 1.

Oxygen is administered via a mask, endotracheal tube, or nasal cannula. Leakage of oxygen generally occurs near the eye region where a tight seal of the mask is difficult to maintain, near the nasal area when a cannula is used, or near the mouth when an endotracheal tube is used.

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Candela Corporation

2.

An oxygen-rich atmosphere is created and dissipates over the face. Transient local concentrations of oxygen can greatly accelerate combustion.

3.

During treatment, the laser beam strikes combustible material, which absorbs the laser energy, and the material is heated above its combustion point. This may occur simply by singeing the tip of a single dry hair.

4.

This momentary, and possibly unnoticeable, ignition sets off a more significant flash fire. The fire then follows a path from the peripheral area of the oxygen enriched atmosphere to the oxygen source.

5.

Other combustible substances are involved as a secondary effect of the initial ignition and may be related to hair, gauze, oxygen delivery devices, anesthesia gases, or byproducts of anesthesia in the oxygen enriched atmosphere. A burn may then occur where this secondary effect is present.

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