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GentleYAG Laser System

Candela Corporation

8501-00-1766 Revision F

CONFIDENTIAL

Page 159

FINAL VERIFICATION OF USER CALIBRATION ENERGY

The final step is to complete user calibrations and to verify the energy is within
specification.

23.

Press the Exit button. This will return the user to the Main user screen.

24.

Complete the following Calibrations using the specified spot size, fluence,
and pulse width from the tables below. After each Calibration, enter Ready
and Pulse 3 times into the Ophir meter. Record each Ophir energy.

25.

Calculate the Average Ophir energy and then the percentage difference
from the expected energy.

26.

Verify the percentage difference of each table is -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

Expected Energy = 10.6J

15mm, 44.0J/cm2, 3ms

Expected Energy = 77.7J

Pulse # OPHIR Energy, J Pulse # OPHIR Energy, J

1

1

2

2

3

3

Avg

Avg

%Diff

%Diff

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Summary of Contents for GentleYAG

Page 1: ...Operator s Manual 0123 8501 00 1766 Revision F June 2006 ...

Page 2: ...ned physician This device should only be used by trained healthcare professionals authorized under applicable local law to treat patients All persons treating patients with this device should ensure that they are authorized to treat patients under the applicable US State or applicable international laws EC Authorized Representative Scanlan Group B V Aalsmeerderweg 610 1437 EJ Schiphol Rozenburg Th...

Page 3: ...cations 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 Section 8 Accessory List Section 9 Service Internal Calibration Procedure ...

Page 4: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 4 ...

Page 5: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 5 Applications Descriptions Specifications Section 1 ...

Page 6: ...12 15 18 GentleYAG HR Laser 12 15 18 GentleYAG SRT Laser 6 8 10 GentleYAG VR Laser 1 5 3 GentleYAG LE Laser System 3 8 12 The Candela GentleYAG Laser system is a flashlamp excited Nd YAG Neodymium doped Yttrium Aluminum Garnet laser Pulsed laser energy is emitted at a nominal wavelength of 1064 nanometers nm This wavelength causes maximum energy absorption by targeting specific chromophores in tis...

Page 7: ...er head a power supply and 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 A calibration port with an internal fluence meter is located centrally on the front of the laser This port is used to calibrate the output of the handp iece at sele...

Page 8: ...cks that disable laser emissions if the remote interlock circuit is open or the fiber is removed A green aiming beam is provided to illuminate the treatment area The aiming beam and treatment beam are dimensionally identical so the aiming beam can be used to accurately define the treatment pulse location The aiming beam is illuminated when the laser enters the Ready State The laser systems can be ...

Page 9: ... Page 9 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: ...eYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 10 FIGURE 1 1 LASER SYSTEM Handpiece Delivery System Laser System Independent Locking Swivel Wheels Control Panel DCD Canister ...

Page 11: ... 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 If the laser system is equipped with the optional DCD the handpiece assembly will contain the DCD spray nozzle safety and detection electronics focusing lenses and an output window to protect the lenses from dust a...

Page 12: ...ystem Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 12 FIGURE 1 2 HANDPIECE DELIVERY SYSTEM Laser Aperture Distance Gauge Location Handpiece Assembly Cable Assembly Valve Control Cryogen Line Fiberoptic ...

Page 13: ...mportant to use the correct distance gauge for the spot size that the laser system is designed for The five types of amber distance gauges are for use with spot sizes from 6 mm to 18 mm Each of the amber distance gauges also contains a window to offer extra protection for the lenses in the handpiece Removal and cleaning of the windows is explained in section 6 of this manual WARNING Use only dista...

Page 14: ...piece To remove the distance gauge pull it straight out Note A properly installed distance gauge has virually no gap between the distance gauge and the distal end of the delivery system Note The distance gauge does not rotate when installed Caution DO NOT USE A SMALLER DISTANCE GAUGE WITH A LARGER TREATMENT SPOTSIZE THE LASER BEAM WILL PERMANENTLY DAMAGE THE DISTANCE GAUGE DO NOT USE A DISTANCE GA...

Page 15: ...emoved from the handpiece using the same technique as for the amber distance gauges The 3 mm distance gauge does not have a window in it This is because the procedures associated with this spot size deliver less energy to the treatment area and create much less debris Note that there is a window at the end of the 1 5 3 mm slider to keep the lenses in it clean Figures 1 4 and 1 5 show the two types...

Page 16: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 16 FIGURE 1 4 GentleYAG 3 mm SMALL DISTANCE GAUGE FIGURE 1 5 GentleYAG 3 mm LARGE DISTANCE GAUGE ...

Page 17: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 17 FIGURE 1 6 GentleYAG 1 5 mm SMALL DISTANCE GAUGE FIGURE 1 7 GentleYAG 1 5 mm LARGE DISTANCE GAUGE ...

Page 18: ... 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 Figure 1 8 shows a close up view of the small 1 5 mm distance gauge before it is inserted into the handpiece slider FIGURE 1 8 1 5 mm SMALL DISTANCE GAUGE AND HA...

Page 19: ...t is centered onto the slider when installed To remove the 1 5 mm distance gauge grasp the support leg and gently rock it back and forth while pulling it out from the slider Caution THE 1 5 MM DISTANCE GAUGES CONTAIN A BUILT IN LENS AS PART OF THE ASSEMBLY THEY ARE THE ONLY DISTANCE GAUGES THAT SHOULD BE USED WHEN THE DELIVERY SYSTEM SLIDER IS ADJUSTED FOR A 1 5 MM SPOT SIZE USE OF ANY OTHER DISTA...

Page 20: ...f the aiming beam is not near the center of the treatment ring If this occurs place the laser in the STANDBY state and remove the distance gauge Then reinsert the 1 5 mm distance gauge using one or two rocking motions as it is pressed onto the slider Recheck the centering of the aiming beam to verify that it is installed properly Caution DO NOT USE A SMALLER DISTANCE GAUGE WITH A LARGER TREATMENT ...

Page 21: ...he arm To adjust the fiber pole turn the black knob counter clockwise and move the pole to the desired position Tighten the black knob clockwise to hold the fiber pole in position CAUTION When using the fiber pole to support the delivery system make sure there are no sharps bends in the delivery system TheGentleYAG Laser System contains a fiber optic cable that can be damaged if subjected to exces...

Page 22: ... CONFIDENTIAL Page 22 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 FIGURE 1 9 FIBER POLE ASSEMBLY ...

Page 23: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 23 FIGURE 1 10 FIBER POLE FOLDED ...

Page 24: ...l up on the lever Table 1 1 Specifications for the GentleYAG Laser System Laser Type Flashlamp excited long pulse Nd YAG laser Wavelength 1064 nm Method of Optical Output Lens coupled optical fiber to handpiece Maximum Delivered Energy per pulse 80 J Accuracy of Output Energy 20 Pulse Repetition Rate Up to 10 Hz Pulse Duration 0 25 300 milliseconds 100 ms max for LE systems Aiming Device Class 1 L...

Page 25: ...on method None required Ingress protection Ordinary enclosed Not AP or APG equipment 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 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 GentleYAG comply ...

Page 26: ...ion 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 2 for electrical service requirements For International installations the power connections should be made with a grounded 2 conductor plug and receptacle pair The plug receptacle must be rated for the service line voltage ...

Page 27: ... 230 V 16 Amp dedicated service Voltage dips and low line conditions may cause the mains breaker to trip periodically The user should consult a qualified Electrician to verify mains quality before connecting to a 16 Amp service GROUND CONTINUITY TESTS Your laser system requires a connection to earth ground to reduce the risk of electric shock To verify that this safety feature is functioning prope...

Page 28: ...ing of the buzzer Before installation of the GentleYAG 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 NOTE Installation of the GentleYAG Laser System must be performed by a ...

Page 29: ...re 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 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 othe...

Page 30: ...ecomes necessary to relocate the GentleYAG Laser System 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 The GentleYAG Laser System is not designed for mobile use 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 ...

Page 31: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 31 Section 2 Hazards Precautions Safety Features ...

Page 32: ...ned 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 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 e...

Page 33: ...d 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 fla...

Page 34: ...1064 NM 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 Remember this and take precautions to avoid inadvertent exposure The cornea and lens of the eye are transparent to i...

Page 35: ... 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 the following table To avoid vision hazards everyone within the NOHD see Table 2 1 of the GentleYAG Laser System must wear appropriate eye protection Protective eyewear is supplied with each laser and is available from a variety of vendors including Candela H...

Page 36: ...to ensure optical safety 1 Appoint one person responsible for the laser system controls during the procedure 2 Ensure that all personnel wear appropriate safety eyewear whenever the laser system is on 3 Never look directly into the laser beam even when wearing protective eyewear 4 Never allow the laser beam to be directed at anything other than the targeted area or the calibration port 5 Never per...

Page 37: ...tage Therefore no part of the exterior housing should be removed except by a trained and authorized technician The GentleYAG laser delivery systems utilize 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 o...

Page 38: ...arge 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...

Page 39: ... the treatment area below 1000 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 ft 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...

Page 40: ...ame area Refer to MSDS sheet 8501 00 1701 for further information Frostbite Risks Treatment areas should have sufficient free floor space to allow a patient or user the ability to move away from an unanticipated spray of cryogen The following table gives some exposure guidelines Visual outer edge of spray Hand detection of outer edge of spray Direct release from canister 27 inches 31 inches Releas...

Page 41: ...in laser procedures should have brushed burnished or blackened non reflective surfaces 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 This flash or flame with each pulse will continue until pulsing is stopped Individuals in contact with this flash or flam...

Page 42: ...NSI A136 3 2005 section 7 3 Laser Generated Air Contaminants LGAC Some mechanism for decreasing LGACs should be used Based on the type of condition being treated by the laser there may be a higher incidence of LGAC Reference the NIOSH Hazard Controls Control of Smoke from Laser Electrical Surgical Procedures bulletin HC11 US Department of Health and Human Services Public Health Service National In...

Page 43: ...issions from a product have been known to interfere with the performance of other equipment in the vicinity The emissions from the GentleYAG 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 interferenc...

Page 44: ...Stop Switch When the red switch with this label STOP underneath located on the lower left side of the control panel is pressed the GentleYAG Laser System is shut down immediately PFN Charged An audible beep will be heard when the laser is ready to deliver a pulse of energy Lasing An audible beep will be heard and the control panel flashes three Lasing Triangle symbols to indicate that the laser is...

Page 45: ... to the STANDBY state The laser will automatically revert back to the STANDBY state after 2 minutes of inactivity in the READY state The operator selects the operating state via the Display Panel System state information is also displayed on the Display Panel When the system is in the READY state the blue lamp to the right of the Display Panel is illuminated Remote Interlock An external connector ...

Page 46: ...to reduce risks associated with exposure The gloves should be disposed of in the same manner as contact parts Other than patient contact parts all external components accessories can be disposed of as regular trash Most internal components that make up the laser system can also be disposed of as regular trash with the exception of the high voltage capacitor and an integrated battery located on the...

Page 47: ...water If disposal of the laser system or its accessories becomes a problem in your area contact Candela for instruction Hazardous Material Hazardous Waste If the laser system includes a DCD option the GentleCOOLTM canister is classified as hazardous Refer to the following matrix Item Hazardous category Comments GentleCOOLTM canister Pressure Must be disposed of as hazardous waste or shipped as haz...

Page 48: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 48 ...

Page 49: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 49 System Operation Features Section 3 ...

Page 50: ...piece Delivery System Receptacles and a Touch Screen Display Panel Display Panel The Display Panel Figure 3 2 provides a simple graphical user interface for the operator The operator uses this interface to select the system operating state laser operating parameters DCD parameters and output energy calibration Display Panel Laser Stop Switch On Off Keylock Switch Ready Lamp Calibration Port Cal Po...

Page 51: ...s off on and start To start the laser turn the key from the position to the position then release The switch spring returns to the position The laser system starts in a few seconds and four quick audible beeps will sound Laser Stop Switch When the red Laser Stop switch is pressed the laser system shuts down immediately To restart the system turn the keylock switch to the position and then release ...

Page 52: ...nel Main Screen Laser State Display Next Screen Button Repetition rate Select Canister Counter Calibrate Button Standby Button DCD Pre Spray Duration Button Fluence Button DCD Delay Button Adjust Up Button Adjust Down Button Pulse width Select DCD Post Spray Duration Button Spotsize Identification PURGE Button Ready Button ...

Page 53: ...oration 8501 00 1766 Revision F CONFIDENTIAL Page 53 Figure 3 3 Next Screen Triggerswitch Select Next Screen Button Calibrate Button Aiming Beam Intensity Spot Size Identification PURGE Button Language Select Pulse Count and Reset Button ...

Page 54: ...aser It is used to assist service personnel in trouble shooting the laser The laser system can not be pulsed in this mode LVM is accessed by depressing and holding the Next button until the LVM screen appears LVM can be exited by one of the following the next button cycle system power or pulse the laser if in READY Note The contents of this screen may vary and is shown for reference only Figure 3 ...

Page 55: ...t 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 The storage position rear basket slot is designed to remove excess slack from the delivery system This reduces the risk of damage to the delivery system while not in use ...

Page 56: ...e that this state is selected 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...

Page 57: ...The window area below the System Status menu bar contains the buttons associated with the Main Menu The laser operating parameters can each be set individually by the operator To change a parameter press the appropriate button and use the up or down arrows to adjust the value to the desired setting The background for the selected parameter is set to black to indicate that their numeric settings ca...

Page 58: ...ulsing in HZ to the maximum rate selected thereby allowing the user to best maintain control during the treatment The product has the following Repetition Rate selections 0 HZ single pulse mode and the multi pulse modes 5HZ 1 HZ 1 5 HZ 2 HZ 3 HZ 5 HZ 7HZ and 10 HZ In multi pulse mode the laser will pulse at a steady rate as long as the delivery system s trigger is depressed Not all selections are ...

Page 59: ...te can be set to 0 single pulse 0 5 1 0 1 5 and 2 0 for all fluences The repetition rate setting is a maximum setting The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD settings 2 Pulsewidth can be set from 10 ms to 100 ms in 10 ms increments and from 125 ms to 300 ms in 25 ms increments Longer pulsewidths reduce the achieved repetition rate Table 3 1 ...

Page 60: ...n 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 The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD settings 2 Pulsewidth can be set from 10 ms to 100 ms in 10 ms increments and from 125 ms to 300 ms in 25 ms increments Longer pulsewidths reduce the achieved repetition rate 100 ms max...

Page 61: ...note 4 125 300 25 ms increments 35 0 200 0 2 note 4 Notes 1 Fluence increments are 1 J cm2 from 6 to 30 J cm2 and 5 J cm2 from 35 to 200 J cm2 2 Maximum Repetition Rate 3 Hz for 6 11 J cm2 5 Hz for 12 20 J cm2 7 Hz for 21 23 J cm2 10 Hz for 24 30 J cm2 3 The repetition rate setting is a maximum setting The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD...

Page 62: ... 0 2 note 4 Notes 1 Fluence increments are 1 J cm2 from 6 to 20 J cm2 and 5 J cm2 from 35 to 150 J cm2 2 Maximum Repetition Rate 3 Hz for 6 J cm2 5 Hz for 7 11 J cm2 7 Hz for 12 13 J cm2 10 Hz for 13 20 J cm2 3 The repetition rate setting is a maximum setting The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD settings 4 The maximum repetition rate is 1...

Page 63: ...35 0 100 0 2 note 4 125 300 25 ms increments 35 0 100 0 2 note 4 Notes 1 Fluence increments are 1 J cm2 from 6 to 12 J cm2 and 5 J cm2 from 35 to 100 J cm2 2 Maximum Repetition Rate 5 Hz for 6 7 J cm2 7 Hz for 8 J cm2 10 Hz for 9 12 J cm2 3 The repetition rate setting is a maximum setting The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD settings 4 Th...

Page 64: ...The repetition rate setting is a maximum setting The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD settings 2 The available pulsewidth settings for each fluence are 3 ms 5 ms 10 100 ms in 10 ms increments and 125 ms to 300 ms in 25 ms increments 100 ms maximum for LE 3 The maximum repetition rate is 1 5 Hz at fluences greater than 26 J cm2 with a 3 ms...

Page 65: ...repetition rate setting is a maximum setting The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD settings 2 The available pulsewidth settings for each fluence are 3 ms 5 ms 10 100 ms in 10 ms increments and 125 ms to 300 ms in 25 ms increments 3 The maximum repetition rate is 1 5 Hz at fluences greater than 16 J cm2 with a 3 ms pulsewidth Longer pulsewi...

Page 66: ...rate setting is a maximum setting The actual repetition rate achieved may be less depending on selected fluence pulsewidth and DCD settings 2 The available pulsewidth settings for each fluence are 3 ms 5 ms 10 100 ms in 10 ms increments and 125 ms to 300 ms in 25 ms increments 3 The maximum repetition rate is 1 5 Hz at fluences greater than 12 J cm2 with a 3 ms pulsewidth Longer pulsewidths reduce...

Page 67: ...om 20 milliseconds to 100 milliseconds in increments of 10 milliseconds The 1 5 3 mm delivery system can access three additional pre spray settings of 10 15 and 25 ms Also to access pre spray times above 30 ms with this delivery system hold down the UP arrow on the display for at least 5 seconds CAUTION DCD spray is not allowed at rep rates greater than 2 Hz The DCD Delay Adjust parameter adjusts ...

Page 68: ...NISTER appears and the canister must be replaced Use of a canister after the counter reaches zero may result in inadequate canister pressure and therefore inadequate cryogen spray Any residual cryogen left in the canister is there as a margin of safety for both you and your client Instructions for replacing the canister are shipped with each canister Install only new full cryogen canisters Install...

Page 69: ...Duration ms Pulses Available Post Spray 0 Pulses Available Post Spray 50 20 16 232 4 637 30 10 821 4 058 40 8 116 3 607 50 6 492 3 246 60 5 410 2 951 70 4 637 2 705 80 4 058 2 497 90 3 607 2 318 100 3 246 2 164 Table 3 9 Cryogen Spray Durations and Pulse Counts for Spot Sizes From 6 mm to 18 mm ...

Page 70: ...able Post Spray 0 Pulses Available Post Spray 50 10 45 754 7 625 15 30 502 7 039 20 22 877 6 536 25 18 301 6 100 30 15 251 5 719 40 11 438 5 083 50 9 150 4 575 60 7 625 4 159 70 6 536 3 812 80 5 719 3 519 90 5 083 3 268 100 4 575 3 050 Table 3 10 Cryogen Spray Durations and Pulse Counts for the 1 5 3 mm Delivery System ...

Page 71: ...FICANTLY REDUCED COOLING OF THE EPIDERMIS FOR A GIVEN LASER ENERGY INADEQUATE PRESSURE TO FILL A TREATMENT AREA DO NOT ATTEMPT TO USE THE CANISTER BEYOND THE FIRST OCCURRENCE OF THE REPLACE CANISTER MESSAGE DO NOT RESET SYSTEM PULSE COUNTERS WITHO UT REPLACING THE CANISTER DO NOT INSTALL PARTIALLY USED CANISTERS YOUR SYSTEM HAS BEEN CONFIGURED FOR A SPE CIFICSIZE GENTLECOOL TM CANISTER ONLY INSTAL...

Page 72: ...etting the lower count value displayed within the PULSE COUNT button to zero The Total Pulse Counter shown on the Laser Variable Mode Screen can not be reset to zero The calibration procedure is initiated by pressing the CALIBRATE button Note that the system will initiate the calibration procedure automatically if READY state is entered a calibration is required and the trigger switch is depressed...

Page 73: ...nnot be turned OFF This button is used to select the repetition rate on the main screen This button is used to access available screens There are two operating screens and one auxiliary screen Laser Variable Mode LVM See Figures 3 1 3 3 for descriptions Laser emission is generated by depressing the trigger switch provided the system is in the READY state calibrated When the trigger switch is press...

Page 74: ...itch contacts are closed When the door is open the switch contacts must open When remote interlock is not in use the supplied jumper must be plugged into the interlock connector The circuit requires a switch with a minimum rating of 24 VDC at 250 mA 1 4 Amp The footswitch connector is located on the rear panel of the laser system The footswitch connector is a rigid tube with a smooth taper To inst...

Page 75: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 75 System Start Up Section 4 ...

Page 76: ...hat the fiber connector at the laser is secure 6 Set up the delivery system on the fiber pole as per section 1 of this manual 7 Inspect and verify that the handpiece window is clean 8 The keylock switch has three positions off on and start The switch returns to the position once the laser system starts and a power on audible beep will sound To start the laser system turn the keyswitch fully clockw...

Page 77: ...ere is an unexplained treatment response noted or the delivery system has been dropped 11 After tests are completed depress the Check Box on the screen displaying the Perform Delivery System Test message 12 Select the desired laser system operating parameters as follows a Select Fluence b Select Pulsewidth c Select Repetition Rate d If system has the DCD option set DCD for desired spray duration a...

Page 78: ...auge and press the READY button Aim the handpiece at a white piece of paper and inspect the aiming laser for circular uniformity and clarity Note If the aiming laser spot is not uniform check for distance gauge interference Replace bent distance gauge if necessary If using the 1 5 mm distance gauge ensure that the aiming beam is at or near the middle of the distance gauge ring If not remove and in...

Page 79: ...ore continuing treatment Place laser in STANDBY state and check the windows on the distance gauge and handpiece slider Dirty windows will reflect laser energy back into the handpiece which will heat it up and cause PURGE faults If possible replace with a cool delivery system 16 Place the laser into STANDBY after use Document laser use CAUTION Failure to initiate a calibration after cleaning replac...

Page 80: ...e required when 1 Laser is turned on 2 FLUENCE parameter or pulsewidth parameter changed 3 Delivery system changed 4 Slider plunger depressed 5 Slider position changed 6 Specific faults occur 7 In STANDBY for more than 30 minutes The user must remember to initiate a calibration after 1 Cleaning or replacing a window in the handpiece Slider 2 Replacing the delivery system 3 Changing the treatment s...

Page 81: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 81 Calibration Procedure Section 5 ...

Page 82: ...thout the Distance Gauge is inserted into the Cal Port allowing an internal energy meter to measure the laser output energy delivered at the handpiece The system adjusts itself until the desired output is obtained Usually 3 15 laser pulses are required before calibration is complete Inspect and verify that the handpiece Slider window is clean Select the desired Delivery System Make sure the Delive...

Page 83: ...arting the calibration procedure After successful completion of the calibration procedure remove the Delivery System from the Calport install the Distance Gauge and begin treatments During calibration the software performs a delivery system transmission check If the delivery system transmission is low the software will display a message to clean the HP Slider window The user can stop the calibrati...

Page 84: ...ystem is degraded and does not have sufficient energy to calibrate properly A dirty window on the handpiece slider may be the cause of the problem Clean or change the window using the instructions in Section 6 Maintenance and Troubleshooting section If the problem cannot be corrected the system may require service Call Candela Service for more information If a higher fluence is desired immediately...

Page 85: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 85 Section 6 Maintenance Troubleshooting Delivery System User Verification Tests ...

Page 86: ...L INJURY AND WILL VOID ANY WARRANTY ON THE LASER SYSTEM The GentleYAG laser delivery system utilizes fiber optics that can be damaged if subjected to excessive bending To avoid damage to the optical fiber limit bends to a radius of 6 inches 15 cm or greater The delivery system should be checked before each procedure by observing aiming beam quality The beam as viewed against a white sheet of paper...

Page 87: ...hed rubber cap whenever the fiber is not installed on the laser Windows have been designed into distance gauges with the exception of the 3mm distance gauge and slider to protect the delivery system optics Due to the nature of some procedures the windows will require frequent cleaning and or replacement to maintain proper system performance Windows should be maintained in accordance with Candela p...

Page 88: ...d water if the level is below the base of the filler neck or if a system message indicates a fault code preceded by a 7 The exterior of the laser system should be cleaned weekly with a soft cloth slightly moistened with a solution of mild soap and water Do not use harsh detergents To disinfect the exterior of the laser system use a soft cloth moistened with an alcohol solution Ethyl or isopropyl a...

Page 89: ...auge Assembly Clean by wiping with gauze pad moistened with an alcohol solution and allow to dry Note Special instructions for the 18 mm distance gauge The 18 mm distance gauge contains a metal washer next to the window Please note the proper assembly when cleaning or replacing the window Note Special instructions for the 1 5mm distance gauge The 1 5 mm distance gauge contains a lens and a window ...

Page 90: ...OPER FLUENCE DELIVERY IT IS IMPORTANT TO INSPECT AND CLEAN THE DISTANCE GAUGE WINDOW FREQUENTLY SO DEBRIS IS NOT BURNED INTO THE WINDOW SURFACE ALWAYS PUT THE LASER SYSTEM INTO STANDBY OR OFF WHEN CHANGING A DELIVERY SYSTEM OR DISTANCE GAUGE WINDOW OR WHEN A HANDPIECE SLIDER WINDOW IS CLEANED OR REPLACED WHEN THE HANDPIECE SLIDER WINDOW OR THE DISTANCE GAUGE WINDOW BECOMES DIRTY OR BURNT THEAMOUNT...

Page 91: ... Page 91 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 Figure 6 1 Distance Gauge 8 mm to 18 mm ...

Page 92: ...Gently pull the O ring toward the center of the window to free the O ring from the groove 5 Turn the assembly upside down allowing the window to fall out onto a clean surface If needed gently tap the side of the Distance Gauge with your finger 6 Used windows only a Clean the windows in an alcohol solution Rinse thoroughly with clean water and dry with a lint free tissue b Re inspect the window and...

Page 93: ...ge 93 For 1 5 mm Black Distance Gauges To clean or replace the Distance Gauge window figure 6 2 1 Wear dustless gloves to prevent smudges or fingerprints on lens 2 Put the laser in STANDBY and remove the distance gauge assembly from the handpiece Figure 6 2 Distance Gauge 1 5 mm Lens ...

Page 94: ... the center of the window to free the O ring from the groove 5 Turn the assembly upside down allowing the window to fall out onto a clean surface If needed gently tap the side of the Distance Gauge with your finger 6 Used windows only a Clean the windows in an alcohol solution Rinse thoroughly with clean water and dry with a lint free tissue b Re inspect the window and if unacceptable discard wind...

Page 95: ...rd the tissue 5 Use a second tissue that is dry and wipe the lens ONCE to clean off the alcohol Discard the tissue 6 Repeat steps 4 and 5 wiping only once with each tissue until the dirt on the lens is removed or no improvement is seen 7 In most cases only the side of the lens that is exposed on the non treatment end of the distance gauge will become dirty The side of the lens that is on the treat...

Page 96: ...ll the O ring toward the center of the window to free the O ring from the groove Then turn the handpiece slider upside down allowing the window to fall out onto a clean surface If needed gently tap the side of the handpiece slider with your finger 4 Used windows only c Clean the windows in an alcohol solution Rinse thoroughly with clean water and dry with a lint free tissue d Re inspect the window...

Page 97: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 97 Figure 6 3 Handpiece Slider Close up O ring HP Slider Window Groove ...

Page 98: ...trol by grasping the connector near the red dot and pulling straight back 2 Remove the Cryogen Line using two hands by pushing the knurled Cryogen Line Receptacle toward the laser and pulling the Cryogen Line Connector away from the laser 3 Remove the Fiber optic by gently pulling the connector straight out of the receptacle 4 Place delivery system into supplied storage case with plastic end caps ...

Page 99: ...ne using two hands by pushing the knurled Cryogen Line Receptacle and the Cryogen Line Connector toward the laser until it stops Release the knurled connector The male and female ends of the connectors fit together 3 Connect the Valve Control by aligning the RED DOT on the Valve Control Receptacle with the RED DOT on the Valve Control Connector and pushing in the connector until it stops ...

Page 100: ...ystem Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 100 RED DOT Figure 6 4 Handpiece Delivery System Close up Valve Control Connector Handpiece Fiberoptic Connector Cryogen Line Connector Laser Aperture ...

Page 101: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 101 Figure 6 5 Control Panel Close up Fiberoptic Receptacle Cryogen Line Receptacle Valve Control Receptacle ...

Page 102: ...temperature or cooler a 20 25 minute WARM UP period will be needed prior to use The WARM UP screen will appear once the laser is switched to the READY state if additional warming is required A canister warmer is available and may be used to hold canisters and minimize the warm up period If a major cryogen leak occurs disconnect the delivery system from the laser or remove the canister from the las...

Page 103: ...formed for the indicated hand pieces at the beginning of each treatment day In addition check the delivery system if there is any concern about the delivery system s performance or the delivery system has been dropped Discontinue use of the delivery system if problems are noted in any of these tests or you suspect observe other factors that may affect performance You will need the following suppli...

Page 104: ...ble Detector Verifies that air bubbles in the cryogen line are detected and the associated fault message is displayed on the system Test 1 Cryogen Alignment Purpose To verify the cryogen spray nozzle is properly aligned with the distance gauge ring This procedure is for all delivery systems Procedure 1 Put the laser in standby Caution laser should remain in Standby mode for duration of test 2 Sele...

Page 105: ...loor View the contact ring of distance gauge looking from the hand piece 6 Press purge button DCD Spray should flow completely through the contact ring There may be a minimal spray mist seen hitting the contact ring No spray should be spraying beyond outside of the contact ring Acceptable No mist on contact ring No Cryo clipping on 12 mm distance gauge ...

Page 106: ... Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 106 Acceptable Small amount of mist on contact Unacceptable results Excess mist on contact ring Cryo clipping on 12 mm distance gauge Small Cryo clipping on 12 mm distance gauge ...

Page 107: ...ment 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 If the result is still unacceptable replace hand piece or contact Candela Technical Support ...

Page 108: ... spot size marking Table 6 1 shows the available distance gauges for the GentleYAG laser system GentleYAG Distance Gauge Part Number 1 5mm 7122 00 3556 small 7122 00 3561 large 3mm 7122 00 3535 small 7122 00 3534 large 8mm 7122 00 3502 10mm 7122 00 3503 12mm 7122 00 3109 15mm 7122 00 3504 18mm 7122 00 3505 Note The part numbers shown for the 8 mm to 18 mm distance gauges are for packages of 5 dist...

Page 109: ...e laser safety glasses 2 Put the laser in Standby Caution laser should remain in Standby mode for duration of test 3 Select DCD on 4 Install appropriate distance gauge from Table 6 2 below 5 Select Spray Duration shown in Table 6 2 6 Place hand piece distance gauge over desired distance gauge spots on the template 1301 00 8291 For 6 mm to 18 mm spot sizes use the 8 mm to 18 mm spots on the templat...

Page 110: ...ay 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 Spot Size Spray Duration Setting 1 5 mm small 30 ms 3 mm small 30 ms 8 mm 30 ms 10 mm 30 ms 12 mm 40 ms 15 mm 50 ms 18 mm 60 ms Note Use the 8 mm distance gauge and 8 mm spot on the template when testing the 6 mm spo...

Page 111: ...e 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 Procedure 1 Insure that the installed DCD canister is not empty Warning Put on appropriate laser safety glasses 2 Turn on the system and allow the WARM UP to complete 3 With the Electrical Connector inst...

Page 112: ...e 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 6 Enter the Ready mode and calibrate the laser by pressing on the footswitch 7 Remove the handpiece from the CALPORT and aim in direction away from personnel such as the floor ...

Page 113: ...ou get PURGE REQUIRED This particular handpiece passed the test You may continue use of this handpiece If PURGE REQUIRED does not occur This particular handpiece failed the test Discontinue use of this handpiece and call Candela Tech Support at 508 358 7637 ex 336 or 800 733 8550 ex 336 9 Reconnect the Cryogen Connector see Figure 3 and press reset to use the system or repeat the test on other Gen...

Page 114: ... only be performed when the touchscreen is not responding correctly The routine can be entered from the diagnostic menu of the laser by pressing the touchscreen calibration button NOTE To access the diagnostic menu Press and hold the next button for 3 seconds When the touchscreen calibration is initiatedthe screen is cleared and the following appears P1 C e n t e r o f S c r e e n TOUCHSCREEN CALI...

Page 115: ...corner of the screen Repeat step 1 3 Two smaller boxes will appear when steps 1 2 have been completed Press both of these buttons until they disappear 4 TOUCHSCREEN Calibration Successful will appear if the calibration is complete If the calibration is unsuccessful the system will return to step 1 This process will repeat 2 times 5 If the calibration is not successful software will use default par...

Page 116: ...is in the off position Switch the circuit breaker to the on position The keylock switch was not fully engaged Turn the keylock switch fully clockwise to the position and release The external interlock is defeated Check the remote interlock connection If connected to a door make sure the door is closed Laser pulses no cryogen is delivered The DCD Pre and Post spray settings are set to zero O Select...

Page 117: ...Service Warm up time has exceeded 60 minutes The water temperature control circuitry failed Call Service Ineffective fluence response System or Fiber is degraded Perform a calibration procedure per Section 5 Call Service if problem persists Replace Canister Message Appears There is insufficient cryogen in the canister Replace the cryogen canister with a new canister supplied by Candela Depress the...

Page 118: ...e Press the purge switch until problem resolves This must be done with the handpiece outside of the calibration port If problem persists call Service Laser will not enter the READY state Triggerswitch is depressed De activate Triggerswitch Aiming beam missing in the READY state Damaged or broken fiber Bad aiming laser or driver circuit Replace delivery system Otherwise call for service TROUBLE SHO...

Page 119: ...r slider windows Dirty or damaged slider optics Failing aiming laser Set aiming beam intensity using button provided on NEXT screen Clean or replace windows Otherwise call for service Aiming beam appears non uniform Dirty distance gauge and or slider windows Dirty or damaged slider optics 1 5 mm distance gauge not installed properly on end of slider Clean or replace windows Replace delivery system...

Page 120: ... operation and will display a warning or fault message FAULT DESCRIPTION 1 1 HP Bubble Circuit Test didn t detect a change in the signal with DCD enabled HP 1 BUBBLE DETECT CIRCUIT FAULT 1 2 Canister Bubble Circuit Test didn t detect a change in the signal with DCD enabled HP 2 ROM CHECKSUM 2 Calculation of checksum at power up does not match checksum value in memory 3 1 Shutter isn t in correct s...

Page 121: ...00 J 6 3 Laser failed to CAL to desired Fluence within 20 pulses 6 CALIBRATION FAULT 6 4 CAL required a HV 1200V for desired Fluence 7 1 DI temp 60degC when not in warm up 7 2 DI temp 70degC while in Ready state 7 3 DI pressure switch does not change when power turned on OR DI pump is not ON or DI pressure switch not actuated 7 DI WATER SYSTEM FAULT 7 4 DI temp Thermistor Open Temperature 5 OR DI ...

Page 122: ...te Cannot change spot size while in Ready 12 1 On last treatment pulse the head energy HD was 14 lower than expected head energy xHD 12 2 On last treatment pulse the head energy HD was 14 higher than expected head energy xHD 12 3 The head energy HD of the last pulse Max Treatment HD Energy of 105J 12 ENERGY OUT OF RANGE FAULT 12 4 The HD total energy is not evenly balanced between each subpulse 20...

Page 123: ...ION FAULT 15 2 Transmission Tx is 100 w HD or CP energy 1 5J Aper 50 w HD 6J or CP energy 2 5 18 1 HD CktCal Test Energy incorrect or chksum corrupt 18 2 DI Factor chksum corrupt 18 CIRCUIT CAL FAULT 18 3 DCD Factor chksum corrupt 19 1 IGBT Trigger Fault 19 2 7875uf capacitor charge status incorrect 19 3 Lasing Timer Fault 19 4 Lasing Power Fault 19 MODULATOR FAULT 19 5 HV Dump Fault ...

Page 124: ...bbles With handpiece removed from the calibration port depress the purge button until the message clears Exit to Clean Window Delivery System Transmission is low Transmission is 75 Delivery system degrading Examine HP Slider window If necessary clean or replace window Candela will make available on request circuit diagrams component part lists descriptions calibration instructions or other necessa...

Page 125: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 125 Labeling Symbols Section 7 ...

Page 126: ...ust be moved to the 1 position See the following figures for label locations Label 1 Indicates to the user that precautions for handling Electrostatic Sensitive device are applicable for the nearby delivery system connector This label is required by agencies to indicate static sensitive connections where electrostatic discharge could potentially damage components of a labeled connection The user s...

Page 127: ...tion Label located on rear side of top cover Label 5 Multi combined label Label is located on rear panel above AC input receptacle A Indicates that accompanying documents contain electrical connection information That information will be found in the Electrical Requirements section of this manual Label is located on rear panel above AC input receptacle B Indicates Footswitch control hose connectio...

Page 128: ...should be kept full to the base of the filler neck with distilled water The label is located on top surface of the reservoir cover Label 9 Laser Identification label This label is marked with the VA rating for the system as well as the model number serial number and date and place of manufacture This label is located on the rear panel Label 10 Multi combined label Located on lower rear panel A Ind...

Page 129: ...3 DCD option only Indicates a hot surface when unit is powered The hot surface warning applies strictly to the heater band which is only accessible when the cryogen tank is removed Accidental contact with the heater band will not cause a burn but may cause an involuntary knee jerk reaction resulting in an injury Label is located on top cover near DCD opening Label 14 International symbol indicatin...

Page 130: ...FIDENTIAL 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 8501 00 1766 Revision F CONFIDENTIAL Page 131 Label Locations Label 1 Label 2 A B C Label 3 ...

Page 132: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 132 Label 4 Label 6 Label 12 Label 7 Label 5 A B C Label 11 Label 10 A B C D E Label 9 16 Label 13 Label 8 Label 17 ...

Page 133: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 133 Label 13 ...

Page 134: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 134 Label Locations Label 14 Label 15 ...

Page 135: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 135 1 2 A B C Label Identification LASER APERTURE 21 57 40 8061 R EV ...

Page 136: ...G Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 136 3 CLASS 4 INVISIBLE LASER RADIATION WHEN OPEN AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION 4 Label Identification ...

Page 137: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 137 5 A B C 6 ...

Page 138: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 138 7 and 13 8 Label Identification H O 2 ...

Page 139: ...rporation 8501 00 1766 Revision F CONFIDENTIAL Page 139 3680 W PULSED LASER CANDELA CORP 530 BOSTON POST ROAD WAYLAND MA 01778 MADE IN U S A Date of Manufacture Model No Serial No 9914 XXXX YYYY 220 230V 50 60 Hz GENTLEYAG APRIL 2004 9 ...

Page 140: ...80 5 109 387 5 066 293 4 887 600 4 829 262 6 171 301 B1 Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No 50 dated July 26 2001 INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT Per EN60825 1 2002 07 MAXIMUM PULSE ENERGY 80 J PULSE WIDTH 0 25 300 ms WAVELENGTH 1064 nm AIMING BEAM CL...

Page 141: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 141 14 11 12 Label Identification Label Identification Label Identification ...

Page 142: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 142 15 7122 00 _______________ REV ________________ S N ________________ 16 17 Label Identification ...

Page 143: ...ent The keylock switch symbol means off only for a part of equipment When the keylock switch is in this position all circuits have been de energized with the exception of the keylock switch circuit itself The keylock switch symbol means on only for a part of equipment When the keylock switch is in this position all circuits are energized and the device will be fully functional The keylock switch s...

Page 144: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 144 ...

Page 145: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 145 Accessory List Section 8 ...

Page 146: ...r Pole 1 Footswitch 15 foot 1 Accessory Kit includes Treatment Guidelines 1 Operator s Manual 1 Eyewear Selection Table 1 Replacement Window Kit Qty 25 1 Label Kit 1 Physician Spectacle 1 Physician Goggles 1 Patient Goggle 1 Key Ring w Candela Tag 1 Canister Empty Valve 1 Laser Warning Sign 1 Service Information Label 1 CE Declaration of Conformity 1 EC Certificate 1 ...

Page 147: ... DCD 1 1 5 3mm DX Gauge Kit 1 8mm DX Gauge Kit 1 10mm DX Gauge Kit 1 12mm DX Gauge Kit 1 15mm DX Gauge Kit 1 18mm DX Gauge Kit 1 GentleYAG LE Delivery System includes 3mm Delivery System with DCD 1 8mm Delivery System with DCD 1 12mm Delivery System with DCD 1 3mm DX Gauge 2 8mm DX Gauge Kit 1 10mm DX Gauge Kit 1 12mm DX Gauge Kit 1 Available Options with DCD GentleYAG HR Delivery System 12 15 18 ...

Page 148: ...e Kit 1 10mm DX Gauge Kit 1 GentleYAG VR Delivery System 1 5 3mm Delivery System with DCD 1 1 5 3mm DX Gauge Kit 1 GentleYAG HR SRT Delivery System 6 8 10 mm Delivery System with DCD 1 12 15 18 mm Delivery System with DCD 1 8mm DX Gauge Kit 1 10mm DX Gauge Kit 1 12mm DX Gauge Kit 1 15mm DX Gauge Kit 1 18mm DX Gauge Kit 1 GentleYAG HR VR Delivery System 1 5 3mm Delivery System with DCD 1 12 15 18 m...

Page 149: ...DX Gauge Kit 1 15mm DX Gauge Kit 1 18mm DX Gauge Kit 1 GentleYAG SRT VR Delivery System 1 5 3mm Delivery System with DCD 1 6 8 10 mm Delivery System with DCD 1 1 5 3mm DX Gauge Kit 1 8mm DX Gauge Kit 1 10mm DX Gauge Kit 1 Description DCD Option includes DCD Assembly 1 12 Pack of Cryogen 1 DCD Cap 1 DCD Canister Warmer ...

Page 150: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 150 ...

Page 151: ...GentleYAG Laser System Candela Corporation 8501 00 1766 Revision F CONFIDENTIAL Page 151 Service Internal Calibration Procedure Section 9 ...

Page 152: ...UALIFIED TECHNICIANS WHO HAVE RECEIVED APPROPRIATE TRAINING FROM CANDELA ANY ATTEMPT BY AN UNAUTHORIZED PERSON TO PERFORM ANY SERVICE PROCEDURE WILL VOID ANY WARRANTY ON THE LASER SYSTEM The measurement circuits should be calibrated annually to insure accurate delivery of treatment energy Measurement circuit calibration should be performed by a qualified Candela Service person as part of a prevent...

Page 153: ... internal energy calibration procedure is described in this section The procedure requires an external laser energy meter whose calibration is traceable to the appropriate national standards agency The external laser energy meter used must be appropriate for the specified output of the laser system with an accuracy of 6 or better and a resolution of 10mJ This procedure is part of the normal preven...

Page 154: ...ction fails contact Candela Customer Service for further information Once the Circuit CAL procedure has been started the previously saved CAL parameters will be erased The Circuit CAL procedure must be completed in order to use the laser for treatment again STARTING THE CIRCUIT CAL PROCEDURE 1 Set the DCD prespray and postspray to 0 From the Main screen go to the Laser Variable Mode LVM screen by ...

Page 155: ...meter 2 Enter the Ophir energy using keypad Always enter to two decimal places 3 Pulse into Cal Port Note the HVr reference or set voltage HVs sample or actual voltage HD Laser Head energy J CP Cal Port energy J are displayed to the right of each screen LASER HEAD HD 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...

Page 156: ... and when to pulse into the calport NOTE Set the Ophir meter on the 30J range After completing the LoPt change the Ophir meter to the 100J range 7 On completion the laser dumps popping sound the stored energy and the screen displays SUCCESSFUL HD CAL 8 Press the 0 20J button beneath the HD column for 1 second to begin the HD circuit calibration procedure 9 The screen will prompt the user with Icon...

Page 157: ... for calculation of the slope and offset The 0 20 Circuit CAL uses the pregain from the 0 120J range so only requires the LoPt and HiPt measurements 11 Press the 0 120J button beneath the CP column for 1 second to begin the CP circuit calibration procedure 12 The screen will prompt the user with Icons when to pulse the laser into the Ophir energy meter when to enter the Ophir meter reading using t...

Page 158: ...The energy circuit factors should be verified prior to exiting the Circuit CAL screens The Factors screen displays all the pertinent Circuit CAL factors as well as provides a Test button to ensure that the Circuit CAL s were done properly 17 Press the Factor button 18 Verify the pregain is not exactly 15000 and is between 12000 and 25000 19 Verify that the slope m factor for both ranges of the HD ...

Page 159: ... pulse width from the tables below After each Calibration enter Ready and Pulse 3 times into the Ophir meter Record each Ophir energy 25 Calculate the Average Ophir energy and then the percentage difference from the expected energy 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 C...

Page 160: ... Page 160 The following test is not required for LE systems 10mm 6 0J cm2 0 50ms Expected Energy 4 7J 10mm 12 0J cm2 0 50ms Expected Energy 9 4J Pulse OPHIR Energy J Pulse OPHIR Energy J 1 1 2 2 3 3 Avg Avg Diff Diff 27 Circuit Calibration is complete the laser can safely be used ...

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