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Candela GentleYAG Operator's Manual

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Operator's
Manual
0123
8501-00-1766 Revision F
June 2006

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Michaela Kalendová
May 6, 2025

How to set the laser when treating a small hemangioma on the lip using a 3 mm spot?

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1 comments:
Michaela Kalendová
May 6, 2025

@Michaela Kalendová We have Candela Yag ND 1064nm

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Summary of Contents for Candela GentleYAG

  • Page 1 Operator's Manual 0123 8501-00-1766 Revision F June 2006...
  • Page 2 GentleYAG Laser System Candela Corporation WARNING! Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Federal (USA) restricts this device to sale by or on the order of a physician. Federal and other international regulations also require that this device be utilized under the direction of a trained physician.
  • Page 3 GentleYAG Laser System Candela Corporation INDEX Section 1……………………Application Description and Specifications. Section 2……………………Hazards, Precautions and Safety Features. Section 3……………………System Operation and Features. Section 4……………………System Startup. Section 5……………………Calibration Procedure. Section 6……………………Maintenance/Troubleshooting and Delivery System User Verification Tests. Section 7……………………Labels and Symbols.
  • Page 4 GentleYAG Laser System Candela Corporation 8501-00-1766 Revision F CONFIDENTIAL Page 4...
  • Page 5 GentleYAG Laser System Candela Corporation Applications Descriptions Specifications 8501-00-1766 Revision F CONFIDENTIAL Page 5...
  • Page 6 The spot sizes included in your laser system depends on which options were purchased. All GentleYAG Laser systems can be upgraded to include all spot sizes. The following table lists all available spot sizes for the GentleYAG Laser systems.
  • Page 7 This allows the operator to select the laser operating parameters, initiate an automatic calibration procedure and select DCD parameters. The GentleYAG Laser System consists of an Nd:YAG laser head, a power supply and Laser System a coolant water circulator. The laser head contains the cavity mirrors, solid-state laser medium (Nd:YAG - Neodymium Yttrium Aluminum Garnet rod), and two high- intensity xenon flashlamps that excite the laser medium.
  • Page 8 GentleYAG Laser System Candela Corporation The systems deliver laser energy at a wavelength of 1064 nm with a pulsewidth of 250 microseconds to three hundred milliseconds. The output of the laser is delivered to the area of treatment through an optical fiber with a treatment handpiece attached to its distal end.
  • Page 9 GentleYAG Laser System Candela Corporation 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.
  • Page 10 GentleYAG Laser System Candela Corporation Handpiece Delivery System Canister FIGURE 1.1 Control LASER SYSTEM Panel Independent Locking/Swivel Laser System Wheels 8501-00-1766 Revision F CONFIDENTIAL Page 10...
  • Page 11 Candela Corporation Multiple handpiece delivery systems are offered with the laser system depending on Handpiece which options are purchased. The GentleYAG Laser System includes three delivery systems (1.5/3 mm slider, 6/8/10 mm slider, 12/15/18 mm slider). Each delivery Delivery system (Figure 1.2) consists of a cable assembly, replaceable distance gauge and a System handpiece assembly.
  • Page 12 GentleYAG Laser System Candela Corporation Laser Aperture & Distance Gauge Location Handpiece Valve Assembly Control FIGURE 1.2 HANDPIECE DELIVERY SYSTEM Cryogen Line Fiberoptic Cable Assembly 8501-00-1766 Revision F CONFIDENTIAL Page 12...
  • Page 13 There are several different circular type distance gauges available for use with the Distance GentleYAG Laser System. The GentleYAG Laser System includes 5 types of amber distance gauges and 4 types of black distance gauges. Each distance gauge is Gauges designed to be used with respective spot sizes with the exception of the 8 mm distance gauge.
  • Page 14 GentleYAG Laser System Candela Corporation FIGURE 1.3 GentleYAG DISTANCE GAUGE (18 mm EXAMPLE) Blue O-ring The amber distance gauge is installed by inserting it, window end first, into the distal end of the handpiece. Align one of the flat areas on the side of the distance gauge with the spray nozzle and gently push until seated in the handpiece.
  • Page 15 GentleYAG Laser System Candela Corporation The four black distance gauges are for use with the 1.5mm and 3 mm spots only. There are two types of distance gauges for each spot size and they are labeled on the support leg similar to the amber distance gauges. Each spot size has a small and large distance gauge with either a small or large treatment ring at the end.
  • Page 16 GentleYAG Laser System Candela Corporation FIGURE 1.4 GentleYAG 3 mm SMALL DISTANCE GAUGE FIGURE 1.5 GentleYAG 3 mm LARGE DISTANCE GAUGE 8501-00-1766 Revision F CONFIDENTIAL Page 16...
  • Page 17 GentleYAG Laser System Candela Corporation FIGURE 1.6 GentleYAG 1.5 mm SMALL DISTANCE GAUGE FIGURE 1.7 GentleYAG 1.5 mm LARGE DISTANCE GAUGE 8501-00-1766 Revision F CONFIDENTIAL Page 17...
  • Page 18 GentleYAG Laser System Candela Corporation The 1.5 mm distance gauge attaches to the delivery system in a different manner than all the other distance gauges. Instead of inserting it into the handpiece slider tube, the 1.5 mm distance gauge is inserted directly onto the laser output end of the slider. This end of the slider only protrudes out of the handpiece when the slider is adjusted for the 1.5 mm spot.
  • Page 19 GentleYAG Laser System Candela Corporation The proper method to install the 1.5 mm is as follows: 1. Grasp the distance gauge by the support leg. 2. Insert the distance gauge into the end of the slider while rocking it back and forth once or twice.
  • Page 20 GentleYAG Laser System Candela Corporation When the laser system is in the READY state, the aiming beam will illuminate. The aiming beam should always be in or near the center of the distance gauge treatment circle. The amber distance gauges and the 3 mm distance gauges are self aligning when they are inserted in the delivery system.
  • Page 21 GentleYAG Laser System Candela Corporation The GentleYAG Laser System is equipped with a fiber pole assembly to assist in Fiber Pole supporting the weight of the delivery systems. The fiber pole is adjustable and can be removed from the laser systems for easy storage.
  • Page 22 GentleYAG Laser System Candela Corporation To completely remove the fiber pole assembly from the laser, firmly pull the bottom pole out of the two grommets on the side. There is a plastic cap at the base of the pole. This cap should be reinstalled with the pole.
  • Page 23 GentleYAG Laser System Candela Corporation FIGURE 1.10 FIBER POLE FOLDED 8501-00-1766 Revision F CONFIDENTIAL Page 23...
  • Page 24 GentleYAG Laser System Candela Corporation The GentleYAG Laser System is equipped with wheels. The two front wheels are LOCKING/ capable of swiveling, which makes parking in tight spaces easy. SWIVEL The front swivel wheels contain levers, which stop the wheels from rotating. To WHEELS prevent the laser from moving, the front wheels must be locked.
  • Page 25 Ordinary enclosed Not “AP” or “APG” equipment Regulatory The GentleYAG Laser System is a Class 4 laser product with a Class 1 aiming beam per EN60825-1 Laser Hazard Classification. The GentleYAG Laser System is a Class Classifications II medical device per FDA 21 CFR 878.4810, and a Class llb (Rule 9), non-invasive, active device according to Annex lX of Directive 93/42/EEC.
  • Page 26 BY A QUALIFIED PERSON IN ACCORDANCE WITH THIS SECTION AND THE ELECTRICAL CODE OF THE INSTALLATION SITE. The GentleYAG Laser System is shipped with a twelve foot (3.7 meter) power cord terminated with a locking NEMA L6-30P plug for power connection in the United States.
  • Page 27 GentleYAG Laser System Candela Corporation GentleYAG Laser System Electrical Requirements: 220 V - 230 V~, 50/60 Hz, 3680 VA TABLE 1-2 ELECTRICAL Installation Site Electrical Service Requirements REQUIREMENTS 208 V - 240 V~, 60 Hz, 30 Amp, center-tapped, single phase, United States dedicated branch circuit with earth ground conductor.
  • Page 28 Before installation of the GentleYAG Laser System, the intended site must be ENVIRONMENTAL prepared as described in this section. The site must have sufficient space to...
  • Page 29 Care should always be taken when moving the GentleYAG Laser System. Remove the footswitch tubing from the connector (located in the rear of the laser) before moving. Guide the GentleYAG 8501-00-1766 Revision F...
  • Page 30 The GentleYAG Laser System is not designed for mobile use. Transport & For transport and storage of GentleYAG Laser System, the temperature must be kept between 40° and 110° F (4.5° and 43° C), and humidity between 20% and 80% (non- Storage condensing).
  • Page 31 GentleYAG Laser System Candela Corporation Hazards Precautions Safety Features 8501-00-1766 Revision F CONFIDENTIAL Page 31...
  • Page 32 PRECAUTIONS unintended viewing or laser light escaping from the laser room. When the GentleYAG Laser System is in operation, restrict entry and limit access to the laser room to those personnel both essential to the procedure and well trained in laser safety precautions.
  • Page 33 GentleYAG Laser System Candela Corporation Hair, gauze, masks, cannula and airway materials can be ignited by laser energy in an FLASH FIRE oxygen-enriched atmosphere even if thoroughly soaked with saline. The following scenario can lead to a flash fire during laser treatment: HAZARDS Oxygen is administered via a mask, endotracheal tube, or nasal cannula.
  • Page 34 ≥ 6.3 @ 1064 NM. PRECAUTIONS The laser beam emitted by the GentleYAG Laser System is capable of causing loss of vision. The laser operates at 1064 nm, which falls within the invisible, near-infrared region of the electromagnetic spectrum. While not visible to the eye, it is still capable of inflicting damage.
  • Page 35 (vision absence in an isolated area), long-term photophobia (sensitivity to light) and/or loss of vision. The laser aperture of the GentleYAG Laser System is at the distal end of the handpiece. The beam enlarges as distance from the handpiece increases. The Nominal Ocular Hazard Distance (NOHD) is the distance at which the beam is so big it is no longer dangerous to the unprotected eye.
  • Page 36 Candela Corporation Maximum delivered energy per EN60825-1:2002 is 96 J. CAUTION! THE LASER BEAM EMITTED BY THE GENTLEYAG S HOULD NEVER BE DIRECTED AT ANY PART OF THE BODY OTHER THAN THE INTENDED SITE OF TREATMENT OR TESTING. Follow these precautions to ensure optical safety:...
  • Page 37 GentleYAG Laser System Candela Corporation 6. When the GentleYAG Laser System is not in use, place it in STANDBY state to prevent accidental pulsing. 7. When the GentleYAG Laser System is unattended, remove the key from the keyswitch to prevent unauthorized use.
  • Page 38 GentleYAG Laser System Candela Corporation CHEMICAL There are no known chemical hazards associated with the GentleYAG Laser System. Hazards The laser system uses a Hydroflourocarbon (HFC), cryogen, in the optional Dynamic Cooling Device (DCD). Cryogen Inhalation: If high concentrations are inhaled, immediately move to fresh air. Keep person calm.
  • Page 39 GentleYAG Laser System Candela Corporation 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.
  • Page 40 Visual outer edge of Hand detection of outer spray edge of spray Direct release from 27 inches 31 inches canister Release from tip of 19 inches 23 inches handpiece For specific customer situations contact Candela Technical Support. 8501-00-1766 Revision F CONFIDENTIAL Page 40...
  • Page 41 Laser Fiber Fire Hazard: GentleYAG Laser System fibers carry significant laser energy. If the fiber were to break during laser pulsing, a sudden flash or flame may be observed at the break point.
  • Page 42 GentleYAG Laser System Candela Corporation 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.
  • Page 43 Laser System have been reduced as far as practical without compromising functionality. If interference from the GentleYAG Laser System is suspected, ensure that the unit is plugged into an AC Mains that is not shared by the affected equipment. If the interference still exists, move the GentleYAG Laser System or the affected equipment into another room.
  • Page 44 This key-operated switch controls electrical power to the laser system. The FEATURES GentleYAG Laser System can be operated only with the key provided by Candela. The key should be removed from the keyswitch when the laser is not in use.
  • Page 45 This interlock switch can be connected to the doors of the laser room. If the door is opened and the GentleYAG Laser System is in the Ready state, the laser system completely shuts down. For more information on installation of a remote interlock, please call Candela Service Note: The interlock must be in position to operate the device.
  • Page 46 GentleYAG Laser System Candela Corporation Residues that accumulate on the delivery system windows and distance gauge during ENVIRONMENTAL normal use may contain infectious viable tissue particulate. Under certain conditions, contact with viable tissue particulate can put a user at risk for contracting disease.
  • Page 47 GentleYAG Laser System Candela Corporation integrated Lithium-ion battery, which is not replaceable or user-serviceable. The IC designated “U7” must be removed and disposed of separately from the laser system in accordance with local disposal laws regulating battery disposal. The fluid in the coolant circulation system contains distilled water and can be disposed of as regular water.
  • Page 48 GentleYAG Laser System Candela Corporation 8501-00-1766 Revision F CONFIDENTIAL Page 48...
  • Page 49 GentleYAG Laser System Candela Corporation System Operation & Features 8501-00-1766 Revision F CONFIDENTIAL Page 49...
  • Page 50 GentleYAG Laser System Candela Corporation The GentleYAG Laser System control panel (Figure 3.1) located on the front of the laser system, consists of an On/Off Keylock switch, a Laser Stop (emergency off) push-button switch, Ready Lamp, Calibration Port, Handpiece Delivery System Receptacles, and a Touch Screen Display Panel (Display Panel).
  • Page 51 Keylock Switch This key-operated switch controls electrical power to the laser system. The GentleYAG Laser System can be operated only with the key provided by Candela. The keylock switch has three positions: “ ” (off), “ ” (on), and “...
  • Page 52 GentleYAG Laser System Candela Corporation Ready Figure 3.2 Adjust Up Laser State Button Button Display Touch Screen Standby Display Panel Button Pre Spray Fluence Duration Main Screen Button Button Pulse width Delay Select Button Repetition rate DCD Post Select Spray...
  • Page 53 GentleYAG Laser System Candela Corporation Figure 3.3 Next Screen Aiming Beam Pulse Count Intensity and Reset Button Triggerswitch Select Language Select Spot Size Identification & PURGE Button Calibrate Next Button Screen Button 8501-00-1766 Revision F CONFIDENTIAL Page 53...
  • Page 54 GentleYAG Laser System Candela Corporation Figure 3.4 Laser Variable Mode Laser Variable Mode (LVM) is a read-only display of system parameters. This screen should not be used during normal operation of the laser. It is used to assist service personnel in trouble-shooting the laser. The laser system can not be pulsed in this mode.
  • Page 55 GentleYAG Laser System Candela Corporation Handpiece Placement: In-use Handpiece Placement: Storage Figure 3.5 Handpiece Basket The handpiece basket provides convenient handpiece storage. The basket has two positions: in- use & storage. The in-use position allows the user a quick convenient place to park the handpiece while in- use.
  • Page 56 The word “STANDBY” is also displayed in the top portion of the Display Panel. The GentleYAG Laser System automatically enters STANDBY state following the initial warm-up period, which occurs when the laser system is first powered up. If the laser has been inactive in the READY STATE for two minutes or if a fault condition is detected, the system reverts to the STANDBY state automatically.
  • Page 57 GentleYAG Laser System Candela Corporation This state is selected by pressing the READY button. The background for the title text of the READY button is set to BLACK to indicate that this state is selected. A two second delay is implemented before laser emission is enabled when the system state changes from STANDBY to READY as a safety precaution.
  • Page 58 GentleYAG Laser System Candela Corporation NOTE The Fluence parameter is the amount of energy density delivered to the selected spot size. The Fluence setting is adjustable in various increments of J/cm for different spot sizes as shown in the following tables (3.1 to 3.8). To calculate the energy from π...
  • Page 59 GentleYAG Laser System Candela Corporation Table 3.1 Available Fluence Settings for the 1.5 mm Spot (J/cm 1.5 mm Fluence, Pulsewidth, Repetition Rate Ranges Notes: 1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, 1.5 and 2.0 for all fluences.
  • Page 60 GentleYAG Laser System Candela Corporation Table 3.2 Available Fluence Settings for the 3 mm Spot (J/cm 3 mm Fluence, Pulsewidth, Repetition Rate Ranges Notes: 1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, and 1.5 for all fluences. The repetition rate setting is a maximum setting.
  • Page 61 GentleYAG Laser System Candela Corporation Available Maximum Minimum Maximum Pulsewidths Repetition Rate Table 3.3 Fluence (J/cm Fluence (J/cm (ms) (Hz) 6 mm Fluence, 0.25 23.0 7 (note 2) 0.30 27.0 10 (note 2) Pulsewidth, 0.35 30.0 10 (note 2) Repetition Rate 0.40...
  • Page 62 GentleYAG Laser System Candela Corporation 0.25 13.0 7 (note 2) 0.30 15.0 10 (note 2) 0.35 18.0 10 (note 2) Table 3.4 0.40 20.0 10 (note 2) 0.45 20.0 10 (note 2) 8 mm Fluence, 0.50 20.0 10 (note 2) Pulsewidth, 35.0...
  • Page 63 GentleYAG Laser System Candela Corporation Available Maximum Minimum Maximum Pulsewidths Repetition Rate Fluence (J/cm Fluence (J/cm (ms) (Hz) Table 3.5 0.25 7 (note 2) 10 mm Fluence, 0.30 10.0 10 (note 2) 0.35 11.0 10 (note 2) Pulsewidth, 0.40 12.0 10 (note 2) 0.45...
  • Page 64 GentleYAG Laser System Candela Corporation Table 3.6 Available Fluence Settings for the 12 mm Spot (J/cm 12 mm Fluence, Pulsewidth, Repetition Rate Ranges Notes: 1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, 1.5, and 2.0 for all fluences.
  • Page 65 GentleYAG Laser System Candela Corporation Table 3.7 Available Fluence Settings for the 15 mm Spot (J/cm 15 mm Fluence, Pulsewidth, Repetition Rate Ranges Notes: 1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, 1.5, and 2.0 for all fluences.
  • Page 66 GentleYAG Laser System Candela Corporation Table 3.8 Available Fluence Settings for the 18 mm Spot (J/cm 18 mm Fluence, Pulsewidth, Repetition Rate Ranges Notes: 1. Repetition rate can be set to 0 (single pulse), 0.5, 1.0, 1.5, and 2.0 for all fluences.
  • Page 67 GentleYAG Laser System Candela Corporation The following operating parameters will only be displayed when the optional Dynamic Cooling Device is installed. The DCD Pre Spray Adjust parameter adjusts the duration of the cryogen spray DCD Pre Spray applied to the patient before the laser pulse. The DCD Pre Spray can be turned off (“O”) or set to a duration from 20 milliseconds to 100 milliseconds in increments of...
  • Page 68 GentleYAG Laser System Candela Corporation The DCD Post Spray Adjust parameter adjusts the duration of the cryogen spray DCD Post Spray applied to the patient after the laser pulse. The DCD Post Spray can be turned off (“O”) or set to duration between 10 and 50 milliseconds, in increments of 10 milliseconds.
  • Page 69 GentleYAG Laser System Candela Corporation Spray Duration Pulses Available Pulses Available Table 3.9 (ms) (Post Spray = 0) (Post Spray = 50) Cryogen Spray 16,232 4,637 10,821 4,058 Durations and 8,116 3,607 Pulse Counts for 6,492 3,246 5,410 2,951 Spot Sizes From...
  • Page 70 GentleYAG Laser System Candela Corporation Spray Duration Pulses Available Pulses Available Table 3.10 (ms) (Post Spray = 0) (Post Spray = 50) Cryogen Spray 45,754 7,625 30,502 7,039 Durations and 22,877 6,536 Pulse Counts for 18,301 6,100 15,251 5,719 the 1.5/3 mm...
  • Page 71 GentleYAG Laser System Candela Corporation CAUTION! FAILURE TO INSTALL T HE APPROPRIATE SIZE CANISTER FOR YOUR LASER OR FAILURE TO REPLAC E IT AS INSTRUCTED CAN LEAD TO ADVERSE CLINICAL OUTCOMES INCLUDING BURNS. SUCH ADVERSE RESULTS MAY OCCUR AS A RESULT OF THE FOLLOWING: •...
  • Page 72 GentleYAG Laser System Candela Corporation There are two pulse counters: Treatment Pulse Counter (shown on the “next” screen) SYSTEM COUNTERS and Total Pulse Counter (shown on the “Laser Variable” Mode Screen). Both counters keep track of delivered pulses but only the Treatment Pulse Counter can be reset.
  • Page 73 GentleYAG Laser System Candela Corporation Spotsize This dual purpose button displays the current delivery system spotsize, and when depressed delivers a cryogen PURGE pulse. The purge button is used to remove air Identification from the handpiece assembly when a new canister or delivery system is installed. The system will prompt the user when a purge is necessary.
  • Page 74 GentleYAG Laser System Candela Corporation The calibration port (Cal Port) is used to measure the laser output energy. The Calibration Port handpiece must be inserted into the calibration port in order to initiate this procedure. The distance gauge must be removed, and the handpiece cleaned and dried before the handpiece is placed in the calibration port.
  • Page 75 GentleYAG Laser System Candela Corporation System Start-Up 8501-00-1766 Revision F CONFIDENTIAL Page 75...
  • Page 76 GentleYAG Laser System Candela Corporation LASER SYSTEM Cover treatment room windows with an opaque material to prevent unintended viewing. START-UP Post laser warning signs at each entrance of the treatment room. Ensure an adequate number of protective eyewear is available. Proper eyewear will filter light at a wavelength of 1064 nm with an O.D.
  • Page 77 GentleYAG Laser System Candela Corporation After warm-up is completed, a warning will appear on the touchscreen to remind the user to perform user verification tests. The warning will read “ “Perform Delivery System Test.” Perform User Verification Tests as outlined in Section 6 of this document.
  • Page 78 GentleYAG Laser System Candela Corporation Note: Repetition rate may be adjusted before or after calibration Note: Before calibration a message will appear on the touchscreen for the user to “Confirm Treatment Parameters”. After confirming, the “check box” must be pressed prior to proceeding with the calibration.
  • Page 79 GentleYAG Laser System Candela Corporation Perform laser treatment. Note: In some cases, when treating large areas, a PURGE fault may appear as a result of the accumulation of reflected heat. If this happens, allow delivery system to cool before continuing treatment. Place laser in STANDBY state and check the windows on the distance gauge and handpiece slider.
  • Page 80 GentleYAG Laser System Candela Corporation NOTES • To return the pulse counter to zero, press the PULSE COUNT button for 3 seconds. • A calibration will automatically be required when: 1) Laser is turned on; 2) FLUENCE parameter or pulsewidth parameter changed;...
  • Page 81 GentleYAG Laser System Candela Corporation Calibration Procedure 8501-00-1766 Revision F CONFIDENTIAL Page 81...
  • Page 82 GREATER THAN SPECIFIED ON THE CONTROL PANEL. The GentleYAG Laser System requires that the laser be calibrated prior to each CALIBRATE patient treatment. During calibration, the handpiece without the Distance Gauge is inserted into the Cal Port allowing an internal energy meter to measure the laser PROCEDURE output energy delivered at the handpiece.
  • Page 83 GentleYAG Laser System Candela Corporation • Fully insert the handpiece into the Cal Port. • Press the CALIBRATE button on the Display Panel and follow the instructions p rovided in the calibration message window. • Remove handpiece from the Calport when instructed to do so and install distance Pressing “X”...
  • Page 84 Clean or change the window using the instructions in Section 6 (Maintenance and Troubleshooting section). If the problem cannot be corrected, the system may require service. Call Candela Service for more information. If a higher fluence is desired immediately, change the delivery system to one with a smaller spot size.
  • Page 85 GentleYAG Laser System Candela Corporation Maintenance/ Troubleshooting & Delivery System User Verification Tests 8501-00-1766 Revision F CONFIDENTIAL Page 85...
  • Page 86 PROCEDURE MAY RESULT IN PERSONAL INJURY AND WILL VOID ANY WARRANTY ON THE LASER SYSTEM. The GentleYAG laser delivery system utilizes fiber optics that can be damaged if FIBER-OPTIC subjected to excessive bending. To avoid damage to the optical fiber, limit bends to a radius of 6 inches (15 cm) or greater.
  • Page 87 Windows should be maintained in accordance with Candela procedure 8502-00-0847. Assembly pictures and procedures specific to the GentleYAG delivery systems are included in this section.
  • Page 88 GentleYAG Laser System Candela Corporation Note: Special instructions for the 18mm distance gauge, the 18mm distance gauge contains a metal washer next to the window. Please note the proper order of assembly when cleaning or replacing the window (shown above).
  • Page 89 GentleYAG Laser System Candela Corporation The distance gauge is the only part of the handpiece to contact the patient. Proper Distance Gauge care of the handpiece distance gauge will result in improved laser performance. To Clean/Disinfect the Distance Gauge Assembly: Clean by wiping with gauze pad moistened with an alcohol solution and allow to dry.
  • Page 90 GentleYAG Laser System Candela Corporation CAUTION! Distance Gauge and ONLY USE GENTLEYAG REPLACEMENT WINDOWS IN HANDPIECE HP Slider Window AND SLIDER OR PERMANENT DAMAGE WILL OCCUR. THE DISTANCE GAUGE ON THE END OF THE HANDPIECE MAY BECOME SOILED WITH NORMAL USAGE. TO ENSURE PROPER...
  • Page 91 GentleYAG Laser System Candela Corporation AFTER REPLACING A DIRTY OR BURNT WINDOW THE LASER SYSTEM MUST BE RECALIBRATED. AFTER REPLACING/CLEANING A DIRTY WINDOW, (OR CLEANING A DIRTY LENS ON THE 1.5 MM DISTANCE GAUGE) YOU MAY NEED TO REDUCE THE FLUENCE TO OBTAIN PRIOR RESPONSE.
  • Page 92 GentleYAG Laser System Candela Corporation For 8 mm to 18mm Amber Distance Gauges To clean or replace the Distance Gauge window: (figure 6.1) Wear dustless gloves to prevent smudges or fingerprints on lens. Put the laser in STANDBY and remove the distance gauge assembly from the handpiece.
  • Page 93 GentleYAG Laser System Candela Corporation Figure 6.2 Distance Gauge (1.5 mm) Lens For 1.5 mm Black Distance Gauges To clean or replace the Distance Gauge window: (figure 6.2) Wear dustless gloves to prevent smudges or fingerprints on lens. Put the laser in STANDBY and remove the distance gauge assembly from the handpiece.
  • Page 94 GentleYAG Laser System Candela Corporation The Distance Gauge window is held in a groove in the front (treatment) end of the assembly with an O-ring. A notched access in the groove allows easy removal of the O-ring and window. Note that the non-treatment end of the distance gauge contains a lens.
  • Page 95 GentleYAG Laser System Candela Corporation To clean the 1.5 mm Distance Gauge lens: (figure 6.2) Wear dustless gloves to prevent smudges or fingerprints on lens. Put the laser in STANDBY and remove the distance gauge assembly from the handpiece. The Distance Gauge lens is on the non-treatment end of the distance gauge.
  • Page 96 GentleYAG Laser System Candela Corporation To clean or replace the HP Slider window: (figure 6.3) Wear dustless gloves to prevent smudges or fingerprints on lens. Turn the laser OFF. Remove the Distance Gauge. Slide the HP Slider through the front of the HP; exposing the slider window or remove the HP Slider entirely from the rear of the HP assembly.
  • Page 97 GentleYAG Laser System Candela Corporation Figure 6.3 Handpiece Slider Close-up Groove Window HP Slider O-ring 8501-00-1766 Revision F CONFIDENTIAL Page 97...
  • Page 98 GentleYAG Laser System Candela Corporation The handpiece delivery system should be replaced with the system turned off. Refer HANDPIECE to figures 6.4 and 6.5 for installation and removal of the handpiece delivery system. When not in use, the delivery systems should be stored in the supplied plastic case DELIVERY with the plastic caps over the ends of the fiber.
  • Page 99 GentleYAG Laser System Candela Corporation CAUTION! IF THE FIBER IS NOT SEATED PROPERLY, DAMAGE TO THE FIBER COULD OCCUR. Connect the Cryogen Line, using two hands, by pushing the knurled Cryogen Line Receptacle and the Cryogen Line Connector toward the laser until it stops.
  • Page 100 GentleYAG Laser System Candela Corporation Handpiece Laser Aperture Figure 6.4 Handpiece Delivery System RED DOT Close-up Valve Control Connector Cryogen Line Connector Fiberoptic Connector 8501-00-1766 Revision F CONFIDENTIAL Page 100...
  • Page 101 GentleYAG Laser System Candela Corporation Figure 6.5 Control Panel Cryogen Close-up Line Receptacle Valve Fiberoptic Control Receptacle Receptacle 8501-00-1766 Revision F CONFIDENTIAL Page 101...
  • Page 102 GentleYAG Laser System Candela Corporation CAUTION! CRYOGEN THE CONTENTS OF THE CRYOGEN CANISTER ARE UNDER PRESSURE. READ THE MATERIAL SAFETY DATA SHEET CANISTER (MSDS) LABEL ON CANISTER BEFORE HANDLING. Follow the instructions shipped with each replacement canister. REPLACEMENT Additionally, once the canister is installed, the canister count must be reset. If the newly installed canister is at room temperature or cooler, a 20 - 25 minute WARM- UP period will be needed prior to use.
  • Page 103 GentleYAG Laser System Candela Corporation Disposal of the canister can be achieved by contacting a waste disposal company. DISPOSAL Alternatively, the canister may be emptied following the instructions that come with each canister and disposing in the trash. Overview of Tests: This section contains information regarding three tests.
  • Page 104 Put the laser in “standby”. Caution- laser should remain in “Standby” mode for duration of test Select “DCD –on”. Install GentleYAG 12mm distance gauge PN 7122-00-3109. The 1.5/3 mm handpiece must be set at the 3 mm spot size. Select 30ms of DCD Spray.
  • Page 105 GentleYAG Laser System Candela Corporation Point hand piece away from objects and personnel (toward the floor). View the contact ring of distance gauge, looking from the hand piece. Press purge button. DCD Spray should flow completely through the contact ring. There may be a minimal spray mist seen hitting the contact ring.
  • Page 106 GentleYAG Laser System Candela Corporation Acceptable Small amount of mist on contact Small Cryo clipping on 12 mm distance gauge Unacceptable results Excess mist on contact ring Cryo clipping on 12 mm distance gauge 8501-00-1766 Revision F CONFIDENTIAL Page 106...
  • Page 107 GentleYAG Laser System Candela Corporation Results Acceptable alignment- no further action needed Unacceptable alignment, repeat the test with a different distance gauge. Repeat test results If the test shows acceptable alignment with the new distance gauge, discard the original distance gauge.
  • Page 108 To verify the proper spray duration required to fill the distance gauge ring. (Note: the distance gauge ring is larger than the spot size marking). Table 6- 1 shows the available distance gauges for the GentleYAG laser system. GentleYAG Distance Gauge Part Number 1.5mm...
  • Page 109 GentleYAG Laser System Candela Corporation 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.
  • Page 110 NOTE: Spray outside of the spot is acceptable as long as the inner spot is completely filled. (This spray may be from reflected spray off the paper). If the spot does not fill or a leak is noted, the handpiece assembly should be replaced or contact Candela Technical Support. Distance Gauge Spray Duration...
  • Page 111 To ensure that that air bubbles in the cryogen line are detected and the associated “fault” message is displayed on the system. Important: This procedure must be done with each GentleYAG handpiece delivery system in your possession. The subsystem being tested is inside of each delivery system, not in the laser system.
  • Page 112 GentleYAG Laser System Candela Corporation Electrical Connector Cryogen Connector Figure 3 - Delivery System Connections 4. Set the DCD spray on the front panel to the highest setting. 5. Set the FLUENCE to the lowest setting (this varies by spot size).
  • Page 113 7637 ex 336 or (800) –733- 8550 ex 336 Reconnect the Cryogen Connector (see Figure 3) and press reset to use the system, or repeat the test on other GentleYAG handpiece delivery systems. 10. Depress “purge” may be required until the line is refilled.
  • Page 114 GentleYAG Laser System Candela Corporation The GentleYAG Laser System incorporates a routine to calibrate the touchscreen of the laser. This touchscreen calibration should only be performed when the touchscreen is not responding correctly. TOUCHSCREEN The routine can be entered from the diagnostic menu of the laser by pressing the CALIBRATION touchscreen calibration button.
  • Page 115 GentleYAG Laser System Candela Corporation Using a cotton swab or small blunt tipped instrument press the center of the flashing box until it disappears. A similar box will appear in the opposite corner of the screen. Repeat step 1. Two smaller boxes will appear when steps 1&2 have been completed. Press both of these buttons until they disappear.
  • Page 116 GentleYAG Laser System Candela Corporation SITUATION PROBABLE TROUBLE- SOLUTION / SYMPTOM CAUSE or INDICATOR SHOOTING The system The power is not Reseat the power cable cannot be connected and check circuit breaker. turned on. properly. The laser system Switch the circuit breaker circuit breaker is to the "on"...
  • Page 117 GentleYAG Laser System Candela Corporation SITUATION PROBABLE TROUBLE- / SYMPTOM SOLUTION CAUSE or INDICATOR SHOOTING Cryogen leak. Tubing breaks in Remove the cryogen the delivery canister or disconnect the system. handpiece assembly from the laser. Call Service. Warm-up time The water Call Service.
  • Page 118 GentleYAG Laser System Candela Corporation SITUATION PROBABLE TROUBLE- SOLUTION / SYMPTOM CAUSE or INDICATOR SHOOTING Purge Bubbles have Press the purge switch Required been detected in until problem resolves. the cryogen line. This must be done with the handpiece outside of the calibration port.
  • Page 119 GentleYAG Laser System Candela Corporation SITUATION PROBABLE SOLUTION TROUBLE- / SYMPTOM CAUSE or INDICATOR SHOOTING • • Set aiming beam Aiming beam Intensity set too appears dim intensity using • button provided Dirty distance on “NEXT” gauge and/or screen slider windows •...
  • Page 120 A fault message typically occurs due to a system malfunction. Sometimes clearing FAULT / WARNING the fault and retrying the previous operation can be successfully accomplished without further faults occurring. If the fault message persists, call Candela Service MESSAGES and report the Fault Number. Fault processing automatically places the system into the Standby state.
  • Page 121 GentleYAG Laser System Candela Corporation CAL completion HV sample to Ready entry HV smp not within +-3% at End of Charge (EOC) OR HV Reference and HV sample not within +-5% at End of 5 – HV TOLERANCE Charge FAULT...
  • Page 122 GentleYAG Laser System Candela Corporation DI temperature < 62degC after 60 minute warm-up 9 – WARM -UP DCD pressure < 105psi after 60 minute warm-up (Only TIMEOUT when DCD enabled) 10.1 HP type changed or unrecognized while in Ready 10 – DELIVERY 10.4 Fiber not detected while in Ready...
  • Page 123 GentleYAG Laser System Candela Corporation Transmission (Tx) is < 70% w/HD or CP energy >1.5J 15.1 (Aper < 30% w/HD>6J or CP energy>2.5) 15 TRANSMISSION FAULT Transmission (Tx) is > 100% w/HD or CP energy >1.5J 15.2 (Aper >50% w/HD>6J or CP energy>2.5) 18.1 HD CktCal Test Energy incorrect or chksum corrupt.
  • Page 124 Transmission is < 75% - window. Delivery system degrading Candela will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other necessary information which will assist the customer’s appropriately qualified technical personnel to repair those parts of equipment which are designated by Candela as repairable.
  • Page 125 GentleYAG Laser System Candela Corporation Labeling Symbols 8501-00-1766 Revision F CONFIDENTIAL Page 125...
  • Page 126 GentleYAG Laser System Candela Corporation The GentleYAG Laser Systems have been labeled in accordance with domestic and LABELS international agency standards. All laser operators should be familiar with the location and meaning of the labels. The symbol on the rear panel of the laser is placed there to draw the attention...
  • Page 127 GentleYAG Laser System Candela Corporation A. The “Man” indicates that the delivery system is equipped with a “Type B” applied part. Indicates the emission of laser energy from this device. Indicates this is the laser aperture. Label 3 The Emergency Laser Stop Red Push Button will turn off the laser quickly.
  • Page 128 A. Indicates laser emission characteristics and classification per the IEC/EN standards. Indicates that this device emits laser energy. CE mark with registration number of Candela’s ISO Registrar. When present, this marking indicates compliance with the European Medical Device Directive. Refer to the Declaration contained inside the accessory kit for details of compliance.
  • Page 129 Candela Corporation D. Indicates compliance with a branch of the US FDA which regulates laser equipment. The GentleYAG Laser System has one labeling deviation pursuant to Laser Notice No. 50, dated July 26, 2001, where the “Danger” label required by 21 CFR 1040.10 (g) was replaced with a label bearing the same technical content defined under IEC/EN 60825-1.
  • Page 130 Label 17 The Waste Electrical and Electronic Equipment (WEEE) Directive label on the rear of the Laser System indicates that the Laser System and its components can not be disposed of as regular trash. Contact Candela Corporation for disposal instructions.
  • Page 131 GentleYAG Laser System Candela Corporation Label Locations Label 2 Label 1 Label 3 A,B,C 8501-00-1766 Revision F CONFIDENTIAL Page 131...
  • Page 132 GentleYAG Laser System Candela Corporation Label 13 Label 11 Label 5 A, B, C Label 4 Label 8 Label 6 Label 7 Label 9 Label 17 Label 10 Label 12 A, B, C, D, E 8501-00-1766 Revision F CONFIDENTIAL Page 132...
  • Page 133 GentleYAG Laser System Candela Corporation Label 13 8501-00-1766 Revision F CONFIDENTIAL Page 133...
  • Page 134 GentleYAG Laser System Candela Corporation Label Locations Label 14 Label 15 8501-00-1766 Revision F CONFIDENTIAL Page 134...
  • Page 135 GentleYAG Laser System Candela Corporation Label Identification L A S E R A P E R T U R E 2-A,B,C 2 1 5 7 - 4 0 - 8 0 6 1 R E V [ ] 8501-00-1766 Revision F...
  • Page 136 GentleYAG Laser System Candela Corporation Label Identification CLASS 4 INVISIBLE LASER RADIATION WHEN OPEN. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION. 8501-00-1766 Revision F CONFIDENTIAL Page 136...
  • Page 137 GentleYAG Laser System Candela Corporation 5-A,B,C 8501-00-1766 Revision F CONFIDENTIAL Page 137...
  • Page 138 GentleYAG Laser System Candela Corporation Label Identification 7 and 13 8501-00-1766 Revision F CONFIDENTIAL Page 138...
  • Page 139 GentleYAG Laser System Candela Corporation PULSED LASER CANDELA CORP., 530 BOSTON POST ROAD WAYLAND, MA 01778 MADE IN U.S.A. Model No. GENTLEYAG Serial No. 9914-XXXX-YYYY 3680 W 220-230V 50/60 Hz Date of Manufacture APRIL 2004 8501-00-1766 Revision F CONFIDENTIAL Page 139...
  • Page 140 GentleYAG Laser System Candela Corporation Label Identification This product may be covered by one or more of the following U.S. patents: 6,200,308 6,059,772 6,041,787 6,032,675 6,026,816 INVISIBLE LASER RADIAT ION 5,979,454 5,814.040 5,810,801 5,599,342 5,598,426 AVOID EYE OR SKIN EXPOSURE...
  • Page 141 GentleYAG Laser System Candela Corporation Label Identification Label Identification Label Identification 8501-00-1766 Revision F CONFIDENTIAL Page 141...
  • Page 142 GentleYAG Laser System Candela Corporation Label Identification 7122-00-_______________ REV ________________ ________________ 8501-00-1766 Revision F CONFIDENTIAL Page 142...
  • Page 143 GentleYAG Laser System Candela Corporation Mains Power Symbols The mains power switch is Located on rear of the system and is marked with "¦ " and " O ". The "¦ " indicates the switch position in which the system is connected to the mains.
  • Page 144 GentleYAG Laser System Candela Corporation 8501-00-1766 Revision F CONFIDENTIAL Page 144...
  • Page 145 GentleYAG Laser System Candela Corporation Accessory List 8501-00-1766 Revision F CONFIDENTIAL Page 145...
  • Page 146 GentleYAG Laser System Candela Corporation Packing List Description Quantity GentleYAG (or GentleYAG LE) Laser System Fiber Pole Footswitch (15 foot) Accessory Kit (includes) • Treatment Guidelines • Operator’s Manual • Eyewear Selection Table • Replacement Window Kit (Qty 25) •...
  • Page 147 10mm DX Gauge Kit • 12mm DX Gauge Kit • 15mm DX Gauge Kit • 18mm DX Gauge Kit GentleYAG LE Delivery System (includes) • 3mm Delivery System with DCD • 8mm Delivery System with DCD • 12mm Delivery System with DCD •...
  • Page 148 Candela Corporation • 12mm DX Gauge Kit • 15mm DX Gauge Kit • 18mm DX Gauge Kit GentleYAG SRT Delivery System • 6/8/10 mm Delivery System with DCD • 8mm DX Gauge Kit • 10mm DX Gauge Kit GentleYAG VR Delivery System •...
  • Page 149 1.5/3mm DX Gauge Kit • 12mm DX Gauge Kit • 15mm DX Gauge Kit • 18mm DX Gauge Kit GentleYAG SRT/VR Delivery System • 1.5/3mm Delivery System with DCD • 6/8/10 mm Delivery System with DCD • 1.5/3mm DX Gauge Kit •...
  • Page 150 GentleYAG Laser System Candela Corporation 8501-00-1766 Revision F CONFIDENTIAL Page 150...
  • Page 151 GentleYAG Laser System Candela Corporation Service Internal Calibration Procedure 8501-00-1766 Revision F CONFIDENTIAL Page 151...
  • Page 152 DURING SERVICING OF THE GENTLEYAG LASER SYSTEM CAN BE EXTREMELY DANGEROUS IF PROPER SAFETY PRECAUTIONS ARE NOT TAKEN. THE GENTLEYAG LASER SYSTEM IS TO BE SERVICED ONLY BY QUALIFIED TECHNICIANS WHO HAVE RECEIVED APPROPRIATE TRAINING FROM CANDELA. ANY ATTEMPT BY AN UNAUTHORIZED PERSON TO PERFORM ANY SERVICE PROCEDURE WILL VOID ANY WARRANTY ON THE LASER SYSTEM.
  • Page 153 GentleYAG Laser System Candela Corporation In normal operation, the Calibration procedure is provided for the user to calibrate the PREFACE energy output of the laser system. During that procedure, the handpiece is inserted in the calibration port, the laser is pulsed, and the energy output of the handpiece is read by internal laser energy detectors.
  • Page 154 This procedure must be followed precisely for proper results. If the “Final verification of User Calibration Energy” section fails, contact Candela Customer Service for further information. Once the Circuit CAL procedure has been started, the previously saved CAL parameters will be erased.
  • Page 155 GentleYAG Laser System Candela Corporation Install the delivery system. Set the slider for 8mm, 12mm, or 15 mm. NOTE: When pulsing into the Ophir energy meter, the meter head must be 6” from the handpiece to prevent damage to the meter head.
  • Page 156 GentleYAG Laser System Candela Corporation slope and offset. The 0-20 Circuit CAL uses the pregain from the 0-120J range so only requires the LoPt and HiPt measurements. Press the “ 0-120J” button beneath the “HD” column for 1 second to begin the HD circuit calibration procedure.
  • Page 157 GentleYAG Laser System Candela Corporation CAL PORT (CP) CIRCUIT CAL (0-120J, 0-20J RANGES) The Circuit CAL basically pulses the laser into an external meter and then into the systems Cal Port at a low and high energy to calculate a slope and offset difference between the two.
  • Page 158 21. Press the Test button. Verify that “Pass” is displayed in all eight locations. 22. If any of these verifications fails, the Circuit CAL needs to be repeated. If it fails more than once, then contact Candela Customer Service for service. 8501-00-1766 Revision F...
  • Page 159 26. Verify the percentage difference of each table is within +-14%. If this verification fails, the Circuit CAL needs to be repeated. If it fails more than once, then contact Candela Customer Service for service. 15mm, 6.0J/cm2, 3ms 15mm, 44.0J/cm2, 3ms Expected Energy = 10.6J...
  • Page 160 GentleYAG Laser System Candela Corporation The following test is not required for “LE” systems. 10mm, 6.0J/cm2, 0.50ms 10mm, 12.0J/cm2, 0.50ms Expected Energy = 4.7J Expected Energy = 9.4J Pulse # OPHIR Energy, J Pulse # OPHIR Energy, J %Diff %Diff 27.

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