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8501-00-1800, Revision 05

Confidential

D-1

Appendix D: 

Candela Corporation

AlexTriVantage Laser System

Electromagnetic Compatibility

J

Medical Electrical Equipment needs special precautions regarding EMC and needs to be 
installed and put into service according to the EMC information provided in the accompanying 
documents. 

Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

For more information regarding the aforementioned notices, refer to the Declaration of 
Conformity and EMC Guidance (8501-00-1822) included in your accessory kit.

AlexTriVantage Laser is EMC compliant with the following accessories:

 

Optical delivery system

 

Pneumatic footswitch

The AlexTriVantage Laser complies with IEC 60601-1-2 (Group 1, Class A) "Electromagnetic 
Compatibility Requirements and Tests". Class A equipment is intended for use in commercial 
and industrial locations. A portion of IEC 60601-1-2 deals with measurements of unwanted 
radio frequency emissions generated from a product. Both radiated emissions (radiated 
through the air) and conducted emissions (conducted into the AC Mains) are measured. 
Radiated and conducted emissions from a product have been known to interfere with the 
performance of other equipment in the vicinity. The emissions from AlexTriVantage Laser 
have been reduced as far as practical without compromising functionality. 

Warning:   The use of accessories, transducers and/or cables other than 
those specified, with the exception of those sold by the manufacturer as 
replacement parts for internal components, may result in increased 
emissions or decreased immunity of the AlexTriVantage Laser.

Warning:   AlexTriVantage Laser should not be used adjacent to or stacked 
with other equipment and that if adjacent or stacked use is necessary, the 
AlexTriVantage Laser should be observed to verify normal operation in the 
configuration in which it will be used.

Содержание AlexTriVantage

Страница 1: ...Operator s Manual PN 8501 00 1800 Revision 05 May 2007 Candela Corporation AlexTriVantage 0123 ...

Страница 2: ...antability or fitness for any particular purpose and shall in no event be liable for any loss of profit or any other commercial damage including but not limited to special incidental consequential or other damages The information in this manual is subject to change without notice at the discretion of Candela Corporation Caution Use of controls or adjustments or performance of procedures other than...

Страница 3: ...ns for Use 1 3 Contraindications and Precautions 1 3 Patient Selection 1 4 Tattoos 1 4 Pigmented Lesions 1 4 Warnings Cautions and Precautions 1 5 Warnings and Cautions 1 5 General Hazards 1 5 Optical Hazards 1 7 Electrical and Mechanical Hazards 1 8 Flash Fire Hazards 1 9 Fire Hazards 1 10 Laser Generated Air Contaminants LGAC 1 10 Electromagnetic Interference 1 11 Precautions 1 11 General Precau...

Страница 4: ...ock Switch 2 8 Calibration Port 2 9 Delivery System Receptacle 2 9 Locking Wheels 2 9 Rear Panel 2 10 Main Power Switch and Power Cord 2 11 Remote Interlock 2 11 Water Receptacle 2 11 Footswitch Connector 2 11 USB Port 2 11 Handle 2 11 Delivery System 2 12 Delivery System Cable 2 13 Handpieces 2 14 Distance Gauge 2 15 Footswitch 2 15 Fiber Pole 2 16 Cabling 2 17 Connecting the Handpiece to the Del...

Страница 5: ...eces Distance Gauge and Lens 4 3 Cleaning the Touch Screen Display Panel 4 4 Maintaining the Fiber Optic Delivery System 4 5 Maintaining the Water Cooling System 4 5 Calibration Procedure 4 6 System Calibration Requirements 4 6 Initiating a Calibration 4 6 Calibration Procedure 4 6 Chapter 5 Troubleshooting the Laser Introduction 5 2 Troubleshooting 5 2 Fault Messages 5 3 Chapter 6 Specifications ...

Страница 6: ...f User Calibration Energy 8 5 Appendix A Pre Treatment Visit General A 1 Counseling A 1 Photographs A 2 Appendix B Treating the Patient Training Requirements B 1 Determining the Therapeutic Energy Level B 1 Treatment B 2 Tattoos B 2 Pigmented Lesions B 3 Determining the End of Treatment B 3 Adverse Effects B 3 Appendix C Post Treatment Care General C 1 Makeup C 1 Other Recommendations C 1 Appendix...

Страница 7: ...ocation of additional information regarding the chosen topic References may include either headings on specific pages or entire chapters Intended Audience This guide is intended for use by physicians Warning Warns the user regarding actions that may result in physical damage to the system or personal injury Caution Cautions the user regarding actions that may result in operational issues or data l...

Страница 8: ... OFF position all circuits except the Keylock Switch circuit have been de energized Label 1 Keylock Switch ON position When the switch is in the ON position all circuits are energized and the laser system is fully functional Label 1 Keylock Switch START position This is a spring loaded keylock switch used to start system operation This position does not start the release of energy Label 2 Emergenc...

Страница 9: ...er Switch ON position Label 11 Remote interlock circuit for door switch Indicates the location of the remote interlock circuit that can be connected to a door switch to shut down the laser if the door is opened during laser emission The symbol illustrates that an open connection will inhibit the lasing function Label 12 Warning Main Power Switch This label draws attention to the main power switch ...

Страница 10: ... are removed or serviced by unauthorized persons There are lethal voltages inside the system enclosure Label 18 Water reservoir Indicates that the reservoir should be filled with deionized or distilled water The reservoir should be filled approximately once a week Label 20 Refer to the Operator s Manual for the safe use of this device Label 21 Provides delivery system information The icon of a man...

Страница 11: ...8501 00 1800 Revision 05 Confidential xi Candela Corporation AlexTriVantage Laser System Label 3 Label 2 Ready State Symbol and Indicator Light Label 1 Front Panel Labels Label 22 ...

Страница 12: ...0 1800 Revision 05 Candela Corporation AlexTriVantage Laser System Label 16 Label 5 Label 4 Label 9 Rear Panel Labels Labels 6 7 8 Label 10 Labels 11 12 Label 13 Label 14 Label 18 Label 19 Label 17 Label 20 Label 15 Label 21 ...

Страница 13: ...stem Chapter 5 Troubleshooting the Laser This chapter describes how to troubleshoot the laser if necessary Chapter 6 Specifications This chapter provides general system specifications Chapter 7 Laser System Packing Lists Accessories and Replacement Parts This chapter details Accessories and provides a packing list Chapter 8 Service Internal Calibration Procedure This chapter details the internal c...

Страница 14: ...xiv Confidential 8501 00 1800 Revision 05 Candela Corporation AlexTriVantage Laser System ...

Страница 15: ... include Overview page 1 2 Laser Treatment of Skin Pigmentation Abnormalities page 1 2 Indications for Use page 1 3 Contraindications and Precautions page 1 3 Patient Selection page 1 4 Tattoos page 1 4 Pigmented Lesions page 1 4 Warnings Cautions and Precautions page 1 5 Warnings and Cautions page 1 5 Precautions page 1 11 Safety Features page 1 14 ...

Страница 16: ...ents in amateur and professional tattoos is strong in the near infrared region of the spectrum Melanin has a very broad absorption band throughout the ultra violet visible and near infrared regions of the spectrum with absorption of light greatest in the ultraviolet and least in the near infrared Other chromophores in the skin such as hemoglobin and oxyhemoglobin have little to no absorption of li...

Страница 17: ...it 6 months after the completion of Accutane therapy History of photosensitivity to infra red light Pregnancy Refer to Candela Corporation policy 0920 23 0814 Seizure disorders Do not treat patients with a history of light triggered seizures Medications and Supplements Daily anticoagulation therapy iron supplements herbal supplements such as ginko ginseng or garlic and fish oil supplements may bru...

Страница 18: ...h this laser system Tattoos that have not been effectively removed by other treatments may respond well to AlexTriVantage laser therapy providing prior treatment modalities caused no excessive scarring or skin damage Pigmented Lesions Pigmented lesions to be treated with the Candela Q Switched Alexandrite Laser include but are not limited to the following Solar or Senile Lentigines Freckles Epheli...

Страница 19: ...not take the place of the procedures and instructions found in the Operator s Guide Failure to use the laser in accordance with such procedures and instructions could result in serious injury to the operator the patient and others as well as damage to the laser system Follow OSHA and ANSI standards for laser safety Protective eyewear must be worn by all persons in the treatment room during laser o...

Страница 20: ...re of the assembly In order to reduce the probability of damage please observe the following guidelines Caution To reduce the risk of personal injury and damage to the Delivery System cable use the Fiber Pole to support the delivery system at all times When not in use insert the Handpiece in the Calibration Port This removes excess slack from the Delivery System cable and reduces the possibility o...

Страница 21: ... exposure to the laser beam Laser safety eyewear should be stored away from direct sunlight at temperatures of 65 F 75 F or 18 24 C WARNING During laser procedures the patient s eyes must be protected The opaque patient goggles provided by Candela are appropriate for most patients It is recommended to place gauze sponges under the opaque patient goggles to ensure that the patient s eyes remain clo...

Страница 22: ...ser delivery system utilizes fiber optics that can be damaged if installed or subjected to excessive bending To avoid damage to the optical fiber limit bends to a radius of 6 inches 15 cm or greater Failure to follow recommended procedures may lead to damage to the fiber or delivery system and or harm to the patient or user When damaged the fiber or delivery system becomes a potential fire hazard ...

Страница 23: ...ent to greatly accelerate combustion 3 During treatment the laser pulse strikes combustible material which absorbs the laser energy resulting in the heating of the material beyond the combustion point This can be as simple as the singeing of the tip of a single hair at the hairline eyebrow or eye lash 4 This momentary and possibly unnoticeable ignition sets off a more significant flash fire The fi...

Страница 24: ...ing immediately Because a break could occur suddenly always position the fiber during each use such that it is in full view For example do not drape the fiber over the shoulder or around the back leaving a portion of the fiber out of view during use Do not lay the fiber across combustible materials during use Do not drape the fiber over the shoulder or back or place it on combustible material Lase...

Страница 25: ...r s Guide designed to protect persons from laser radiation affecting the eye status of users by implementing a thorough system of examination and reporting Laser Room Precautions Identify the laser room clearly Post appropriate warning signs in prominent locations at all entrances to the laser room Cover all windows portholes etc with opaque material to prevent unintended viewing or laser light es...

Страница 26: ...he AlexTriVantage Laser Never look directly into the laser beam coming from the laser system or reflected from a surface even when wearing protective eyewear Never allow the laser beam to be directed at anything other than the targeted area the calibration port or a safe beam stop Never permit reflective objects such as jewelry watches instruments or mirrors to intercept the laser beam When the la...

Страница 27: ...use any flammable substance such as alcohol or acetone in the preparation of the skin for treatment Use soap and water if necessary When alcohol is used to clean and disinfect any part of the Handpiece it must be allowed to dry before the laser is pulsed Anesthetics Anesthetics administered either by inhalation or topically must be approved as non flammable Instruments Since laser beams are reflec...

Страница 28: ...the Screen Lock button on the Touch Screen Display Panel is pressed a dialog box request if you want to lock the screen Locking the screen prevents unauthorized use of the laser system Lock the screen by selecting the checkmark confirm in the dialog box The system will be put into Standby and all screen buttons except for the Screen Lock button itself will be locked A Candela logo screen with a pa...

Страница 29: ...by state after 2 minutes of inactivity in the Ready state You select the operating state via the Touch Screen Display Panel System state information is displayed on the Status Area of the Touch Screen Display Panel When the system is in the Ready state the Ready Indicator on the front panel and the Delivery System Cable Indicator are also illuminated For more information see Calibration Button on ...

Страница 30: ...1 16 Confidential 8501 00 1800 Revision 05 Candela Corporation AlexTriVantage Laser System ...

Страница 31: ...ge 2 10 Main Power Switch and Power Cord page 2 11 Remote Interlock page 2 11 Water Receptacle page 2 11 Footswitch Connector page 2 11 USB Port page 2 11 Handle page 2 11 Delivery System page 2 12 Delivery System Cable page 2 13 Handpieces page 2 14 Distance Gauge page 2 15 Footswitch page 2 15 Fiber Pole page 2 16 Cabling page 2 17 Connecting the Handpiece to the Delivery System Cable page 2 17 ...

Страница 32: ...tton and Status Area page 2 23 Fluence Controls and Indicators page 2 26 Pulse Duration Control page 2 26 Spot Size Identifier Bar page 2 27 Pulse Rate Control page 2 27 Pulse Count and Pulse Count Reset Button page 2 27 Treatment Summary Button page 2 28 Screen Lock Button page 2 31 Dialog Boxes page 2 33 ...

Страница 33: ...aser medium A calibration port with an internal meter is located on the control panel which is used to verify the transmission of the optical fiber and Handpiece and to calibrate the output of the Handpiece at selected fluence levels The temperature of the laser head is regulated by the circulation of deionized or distilled water at a controlled temperature To provide energy to the flashlamps a hi...

Страница 34: ...ch time the trigger switch is depressed or pulses may be delivered repetitively as long as the switch is depressed at repetition rates up to 5 pulses per second The AlexTriVantage Laser control panel enables the user to select the desired energy density fluence level and repetition rate The control panel is also used to enable or disable the triggering of the laser to initiate the calibration feat...

Страница 35: ...iption of the front panel components Touch Screen Display Panel The Touch Screen Display Panel provides a simple graphical user interface for the operator The operator uses this panel to set the operating mode and laser parameters All system status is also displayed on this panel For complete details on the Touch Screen Display Panel see Touch Screen Display Panel on page 2 19 Touch Screen Display...

Страница 36: ...each one Figure 2 3 Controls and Connectors on the Front Panel Ready Indicator This indicator shows that the laser has been calibrated and is armed It will remain in Standby no energy will be released until you press the Ready button and then press the footswitch Touch Screen Display Panel Calibration Port Emergency Laser Stop Ready Indicator On Off Keylock Switch Delivery System Receptacle Laser ...

Страница 37: ...this button is pressed the AlexTriVantage Laser is shut down immediately See Figure 2 4 for a detailed view of the button Figure 2 4 Keylock Switch Positions To restart the laser system after an emergency stop turn the Keylock switch to the Start position and release Start Position Off Position On Position Emergency Laser Stop Keylock Switch ...

Страница 38: ...osition Description Off When the Keylock switch is in the Off position all circuits are de energized except the Keylock switch circuit itself On When the Keylock switch is in the On position all circuits are energized The laser becomes fully functional when the Keylock switch is turned past On to the Start position Start Start is a spring loaded keylock position used to start system operation The ...

Страница 39: ... The Proximal end of the Delivery System cable is connected to this receptacle This is a keyed receptacle so that the Delivery System cable cannot be installed incorrectly For more information on the Delivery System cable see Delivery System on page 2 12 Locking Wheels The AlexTriVantage system is equipped with wheels The two front wheels can swivel to allow for maneuverability The rear wheels are...

Страница 40: ...Rear Panel Figure 2 6 shows the rear view of the AlexTriVantage Laser System Figure 2 6 Rear View of Laser System The following sections provide a brief description of the rear panel components Main Power Switch Remote Interlock Main Power Cable USB Port Water Receptacle Footswitch Connector ...

Страница 41: ...or safety The cable plugged into the remote interlock is attached to a switch on the laser room door If the door is opened when the laser is in the Ready State the interlock causes the laser to revert to the Standby state Water Receptacle The laser head is cooled with deionized Water DI or distilled water which is in turn cooled by ambient air passing through a heat exchanger The water receptacle ...

Страница 42: ...mbly a Distance Gauge and a Fiber Pole Figure 2 7 shows the Delivery System Cable Figure 2 8 shows the connectors on each end of the Delivery System Cable and the Handpieces and the Distance Gauge Figure 2 7 Delivery Cable System Delivery System Cable Delivery System Receptacle Calibration Port Proximal End of Delivery System Cable Distal End of Delivery System Cable Receptacle ...

Страница 43: ...ront panel of the system The Distal end of the cable is connected to one of the three Handpieces provided The Distal end of the cable with the Handpiece attached is inserted into the Calibration Port to calibrate the laser before treating a patient There is an Indicator on the Distal end of the Delivery System cable that indicates that the laser is armed and ready for use see Figure 2 9 Proximal E...

Страница 44: ...l end of the Delivery System Cable The Handpieces are keyed so they can cannot be connected incorrect The Handpiece also has a Ready Indicator that is illuminated when the system is armed and ready to deliver energy to treat a patient Use the Treatment Guidelines to determine the Handpiece to be used for a specific treatment The correct Handpiece is then connected to the Delivery System Cable Afte...

Страница 45: ...all of the three Handpieces The Distance Gauge must be removed before the distal end of the Delivery System cable is inserted into the Calibration Port Footswitch The energy is delivered through the laser when the Footswitch is depressed The amount of energy delivered and the length and number of pulses delivered depends on the settings selected during setup The Footswitch is connected to the Foot...

Страница 46: ...ends at 90 degrees and can be moved in a 360 degree motion There is a bearing with a hook at the end for the fiber This bearing will traverse the now horizontal part of the Fiber Pole allowing free range of movement When not in use the Fiber Pole can be folded and retracted back into the system for storage Delivery System Cable Fiber Pole Caution To reduce the risk of personal injury and damage to...

Страница 47: ...m Cable Connect the Handpiece to the distal end of the Delivery System cable see Figure 2 12 All three Handpieces connect in the same way Figure 2 12 Connecting the Handpiece to the Delivery System Cable The connectors are keyed and have orientation marks to help you align the connectors correctly The range for the Fluence parameter will be set up automatically based on the Handpiece that is insta...

Страница 48: ...rrectly One of the three Handpieces must be connected to the distal end Delivery System cable before it is inserted into the Calibration Port The Distance Gauge cannot be attached to the Distal end of the Delivery System cable when it is inserted in the Calibration Port Figure 2 13 Cable Connections on the Front Panel Calibration Port Delivery System Receptacle Proximal end of Delivery System Cabl...

Страница 49: ...ay Panel Figure 2 14 shows the main display screen Figure 2 14 Touch Screen Control Panel Main Screen System Configuration and Maintenance Mode Button Standby Ready Button and Status Area Screen Lock Button System Status Messages Message Spot Size Identifier Bar Pulse Duration Control Pulse Rate Control Pulse Count and Reset Treatment Summary Button Calibration Button Fluence Controls Indicator Ap...

Страница 50: ...uidelines Figure 2 15 Applications Drop Down Menu When you make a selection from this list the selected application turns blue and a submenu with additional options will appear The submenu also lists the spot sizes available for each treatment type Figure 2 16 Applications Submenus When you select the treatment option and install the selected Handpiece the system will automatically set the operati...

Страница 51: ...u select the Application Menu Bar or press X next to the Application Menu Bar Refer to the Candela Clinical Treatment Guidelines Candela Clinical Treatment Guidelines on page 2 22 for the recommended preset treatment parameters and the spot sizes for the desired treatment applications See Performing a Laser Treatment on page 3 2 for instructions on performing patient treatments Read and follow all...

Страница 52: ...ferenced documents System Status Messages System messages such as Needs Calibration Ready Standby etc are displayed in this area Warning The Preset Treatment Parameters and Clinical Treatment Guidelines do not take the place of the procedures and instructions found in the Operator s Guide FAILURE TO USE THE LASER IN ACCORDANCE WITH SUCH PROCEDURES AND INSTRUCTIONS COULD RESULT IN SERIOUS INJURY TO...

Страница 53: ...ation when you start the system and anytime you change the Handpiece If you select the Calibration button and the system was already calibrated the system stays in the Standby state rather than entering the Ready state If you select the Calibration button and the system has not been calibrated you are prompted to start the calibration You are also prompted to calibrate the system if you change the...

Страница 54: ...alibrated if needed The Handpiece has been removed from the Calibration Port The Distance Gauge has been installed NOTE If the laser remains idle unused for more than two minutes in the Ready state it will automatically revert back to the Standby state Standby Select the Standby button the lower right button to place the system in Standby The laser is disabled when the system is in Standby When yo...

Страница 55: ...he laser is first powered on It also automatically enters Standby if the laser is idle for more than 2 minutes while in the Ready state Ready When the Ready button is green the system is in the Ready state When Ready the laser is armed and ready for use Laser energy will not be emitted until you press the Footswitch while the system is in the Ready state The Ready Indicator above the Keylock Switc...

Страница 56: ...increments of 0 25J cm2 between the lower and upper Fluence values for each spot size and duration To change the Fluence setting select the up and down arrows see Figure 2 19 The Fluence defaults to the lower setting for the selected spot size Figure 2 19 Fluence Control Pulse Duration Control The Pulse Duration parameter is the duration of the pulse delivered to the patient see Figure 2 20 The bu...

Страница 57: ... each depression of the Footswitch If you select a number between 1 and 5 the laser will pulse the selected number of times for each depression of the Footswitch For example if you press 3 the laser will pulse three times for each depression of the Footswitch while if you press 4 the laser will pulse four time for each Footswitch depression Figure 2 22 Pulse Rate Control Pulse Count and Pulse Coun...

Страница 58: ...utton see Figure 2 24 to display the Treatment Summary Table see Figure 2 25 Figure 2 24 Treatment Summary Button Figure 2 25 Treatment Summary Table Press and hold the Reset button on the Treatment Summary Table to clear all treatment data from the table memory System Configuration and Maintenance Mode Button The System Configuration and Maintenance Mode button is represented by a wrench see Figu...

Страница 59: ...ench button Set Main ten ace Mode hold the Wrench button for at least 5 seconds Setting the System Configuration If you quickly tap the wrench button the system allows you to set the system configuration Figure 2 27 shows the System Configuration screen Figure 2 27 System Configuration Screen Language Select Aiming Beam Intensity Select Laser Variable Mode Button ...

Страница 60: ...age is highlighted with a white check mark in a blue circle next to it see Figure 2 27 Aiming Beam Intensity Button Use this button to select from three aiming beam intensity levels The red aiming beam which is visible only in the Ready state serves as a treatment area target as well as an emissions warning indicator The aiming beam cannot be turned off Laser Variable Mode Screen Button This scree...

Страница 61: ...ected software lock to prevent unauthorized use of the laser The laser remains in warm up mode when the software lock is engaged To lock the screen select the Screen Lock button see Figure 2 29 Figure 2 29 Screen Lock Button A dialog appears asking if you want to lock the screen now see Figure 2 30 Figure 2 30 Lock Screen Now Screen Select the checkmark to confirm the screen lock or select the X t...

Страница 62: ...e 2 31 Candela Screen Lock Screen To unlock the screen press the Unlock button on the Lock screen A keypad displays on which you can enter a 4 digit code see Figure 2 32 Figure 2 32 Keypad to Unlock Screen The code will be the same for all lasers and the code is 5277 If the laser is locked and the system power is cycled off and on the system will remain locked until the 4 digit code is entered Unl...

Страница 63: ...ide information Figure 2 33 shows an example of a dialog box Figure 2 33 An Example of a Dialog Box Many dialog boxes provide a message and required that you either confirm the message or cancel the action To confirm a message in any dialog box select the checkmark To cancel the action select the X see Figure 2 34 Figure 2 34 Confirm and Cancel Buttons in Dialog Boxes Select Checkmark to Confirm M...

Страница 64: ...2 34 Confidential 8501 00 1800 Revision 05 Candela Corporation AlexTriVantage Laser System ...

Страница 65: ...l 3 1 Chapter 3 Candela Corporation AlexTriVantage Laser System Using the Laser 3 Topics described in this chapter include Introduction page 3 2 Performing a Laser Treatment page 3 2 Before You Begin page 3 2 Treatment Procedure page 3 3 ...

Страница 66: ...r system from moving inadvertently lock each front wheel Verify that the Handpieces and the Distance Gauge which will be used during this procedure are clean Caution Before starting up the laser system for any reason the operator must ensure that all personnel in the area are familiar with the safety concerns outlined in Warnings Cautions and Precautions on page 1 5 and that they are equipped with...

Страница 67: ... the system enters the Standby state The Standby Ready button is yellow indicating the system is in Standby see Figure 3 1 Figure 3 1 System is in Standby 2 Select the Handpiece to be used for the treatment and connect it to the Distal end of the Delivery System cable see Figure 3 2 All three Handpieces connect in the same way Figure 3 2 Connecting the Handpiece to the Delivery System Cable The co...

Страница 68: ...not installed a message displays indicating the Handpiece is not in the Calibration Port 4 A dialog prompts you to perform a Delivery System Test see Figure 3 4 During this test the system analyzes the Handpiece that has been inserted into the Calibration Port Figure 3 4 Delivery System Test Dialog Select the checkmark to perform the test Calibration Port Delivery System Receptacle Proximal end of...

Страница 69: ...eating the patient see Figure 3 5 See www MyCandela com for the latest version of the guidelines Figure 3 5 Treatment Guidelines Dialog Select the checkmark when you have completed this task 6 From the main screen on the Touch Screen Display Panel see Figure 3 6 select the settings for the patient being treated as described in Table 3 1 Figure 3 6 Main Screen on Touch Screen Display Panel ...

Страница 70: ... the system Increase or decrease the fluence as needed within the specified range by selecting the up and down arrows Pulse Duration Pulse Duration Nanoseconds 50 ns 100 ns Pulse Rate Select the pulse rate The pulse rate is the number of pulses delivered with each depression of the Footswitch The choices are Single one pulse delivered 1 one pulse delivered 2 two pulses delivered 3 three pulses del...

Страница 71: ...e 3 8 System is in the Ready State The Confirm Calibration Parameters dialog appears asking you to confirm the parameters you have specified see Figure 3 9 Figure 3 9 Confirm Calibration Parameters Dialog 9 Verify that the parameters selected are correct for the patient and select the checkmark to confirm the settings If the settings are not correct select the X to cancel 10 The system prompts you...

Страница 72: ...otswitch A dialog prompts you to remove the Handpiece from the Calibration Port 13 Remove the Handpiece from the Calibration Port A message appears in the System Status Message Area indicating the calibration is complete The system reverts to Standby the Standby Ready turns yellow when you remove the Handpiece see Figure 3 11 Figure 3 11 Standby 14 Insert the Distance Gauge onto the Handpiece see ...

Страница 73: ...ergy is being delivered yet Figure 3 14 Ready Indicators on Front Panel and Delivery System Cable 16 Use the Footswitch to perform the laser treatment When the Footswitch is depressed laser energy is released and the Ready Status button displays the Lasing symbol see Figure 3 15 Indicator on Distal End of Delivery System Cable Ready Indicator on Front Panel Warning Do not operate the laser if the ...

Страница 74: ...s while in Ready state the system automatically reverts to the Standby state Note If you choose to change the Fluence setting during the treatment by selecting the up and down arrow buttons a confirmation message displays before the new settings take effect Select the checkmark to confirm the new setting Notes To return the Pulse Counter to zero press the Pulse Count Reset button for at least two ...

Страница 75: ...rmation page 4 2 Cleaning and Disinfecting page 4 3 Cleaning the Exterior of the Laser System page 4 3 Cleaning the Handpieces Distance Gauge and Lens page 4 3 Cleaning the Touch Screen Display Panel page 4 4 Maintaining the Fiber Optic Delivery System page 4 5 Maintaining the Water Cooling System page 4 5 Calibration Procedure page 4 6 System Calibration Requirements page 4 6 ...

Страница 76: ...e laser system as discussed in Calibration Procedure on page 4 6 Solutions to the most common operating problems are provided in Troubleshooting on page 5 2 The fault messages that appear on the front panel display described in Fault Messages on page 5 3 All other maintenance and service must be performed by a qualified service representative Routine preventive maintenance of the laser system shou...

Страница 77: ...eaning and or replacing the Delivery System the Handpiece or the Distance Gauge Warning Always clean the Handpiece with disinfecting wipe prior to insertion into the Calibration port Warning Always recalibrate the laser after fixing cleaning or replacing the delivery system Handpiece or distance gauge Failure to initiate a calibration after cleaning replacing these parts may result in delivery of ...

Страница 78: ...on then lift the applicator off the lens 3 Discard the used applicator If the lens is wiped more than once with the same applicator the contamination will spread around the lens 4 Repeat using new applicators for each single pass until the contamination has been removed A Handpiece with minor deposits burned onto the lens can still be used for treatment The calibration procedure will compensate fo...

Страница 79: ...uld also check the level if you receive a fault message preceded by a 7 which indicates a fault in the DI system The water cooling system holds about 3 4 of a gallon of DI water The water tank is located on the rear of the laser system To check the water level 1 Turn off the laser and allow it to cool down 2 Turn the filler cap counter clockwise to remove 3 Inspect the water level by looking into ...

Страница 80: ...rol panel Energy field 3 The user changed the control panel Handpiece field 4 A warning or fault has occurred requiring a calibration before treatment can continue 5 The system has been in the Standby state for more than 30 minutes If a calibration is required and the user attempts to treat by pressing the trigger switch the system will not allow the treatment pulses and indicates a calibration is...

Страница 81: ...essage will be displayed CALIBRATING Xmm HANDPIECE 5 When the calibration procedure is complete the following message will be displayed CAL OK RELEASE TRIGGER SWITCH 6 Release the trigger switch 7 Remove the Handpiece from the calibration port 8 Reattach a cleaned or new distance gauge See Cleaning and Disinfecting on page 4 3 for the Handpiece distance gauge and aiming guide cleaning procedure If...

Страница 82: ...4 8 Confidential 8501 00 1800 Revision 05 Candela Corporation AlexTriVantage Laser System ...

Страница 83: ...on 05 Confidential 5 1 Chapter 5 Candela Corporation AlexTriVantage Laser System Troubleshooting the Laser 5 Topics described in this chapter include Introduction page 5 2 Troubleshooting page 5 2 Fault Messages page 5 3 ...

Страница 84: ...ition and release The system will not go into the Ready state WARNING SECURE REMOTE INTERLOCk CONNECTOR Check the remote interlock connection Press any control panel switch to clear the warning message WARNING RELEASE TRIGGER SWITCH The trigger switch must not be pressed when entering the Ready state This is a safety precaution to prevent unexpected pulsing Press any control panel switch to clear ...

Страница 85: ...mber Fault processing automatically places the system into the Standby state The following conditions occur outside of normal system operation When the system enters a fault condition it beeps and displays a fault message see page 5 3 for an example of a fault message Figure 5 1 Example of Fault Message Table 5 2 lists the possible fault messages and possible solutions to resolve them These soluti...

Страница 86: ... or 86 Call Candela Technical Support Fault 3 Atten2 Fault 3 3 Attenuator 2 is not in correct state when checked Does not respond to actuation to correct state OR Attenuator 2 transmission is outside valid range of TBD Call Candela Technical Support Fault 4 HVPS Fault 4 2 High Voltage Power Supply Communications Time out Turn off laser for at least 5 seconds Restart and calibrate laser If fault me...

Страница 87: ...AL Put laser in Standby and allow sufficient time for laser to warm up Verify that the laser room environment and temperature meet the specifications provided in Environmental Requirements on page 6 5 Verify that the water level is correct If fault message persists call Candela Technical Support Fault 7 DI System Fault Water 7 2 DI temp 66 C Turn off laser and allow sufficient time for it to cool ...

Страница 88: ...echnical Support Restart and turn off laser 2 3 times to allow fluid system to pump water and flush out bubbles If fault message persists call Candela Technical Support Fault 7 DI System Fault Water 7 4 Temperature Sensor Fault sensor circuit open or shorted OR DI temp 9 C OR DI temp 90 C Call Candela Technical Support Fault 9 Warm Up Timeout 9 1 DI temperature not in normal range after 30 minute ...

Страница 89: ...12 1 Head energy HD of last treatment pulse was 14 lower than expected head energy xHD Try to calibrate the laser system Contact Candela Technical Support Fault 12 Energy Out of Range Fault 12 2 Head energy HD of last treatment pulse was 14 higher than expected head energy xHD Try to calibrate the laser system Contact Candela Technical Support Fault 12 Energy Out of Range Fault 12 3 Head energy HD...

Страница 90: ...y System If fault message persists call Candela Technical Support Fault 18 Circuit Cal Fault 18 1 HD CP CktCal Test Energy incorrect or checksum corrupt Contact Candela Technical Support Fault 18 Circuit Cal Fault 18 2 DI Factor checksum corrupt Contact Candela Technical Support Fault 21 Code Update Fault 21 Not currently implemented Fault 22 Interprocessor Comm 22 Not currently implemented Fault ...

Страница 91: ...6 Candela Corporation AlexTriVantage Laser System Specifications 6 Topics described in this chapter include System Specifications page 6 2 Electrical Requirements page 6 4 Environmental Requirements page 6 5 Internal Cooling Water Requirements page 6 6 ...

Страница 92: ...tical fiber light guide with snap on Handpiece Beam Output Mode Multimode Aiming Beam Class 3R aiming beam per EN60825 1 Laser Hazard Classification 650 nm 20 3 5mW Maximum Radiant Power 12 5 x 106 W Maximum Radiant Energy 625 mJ Pulse Repetition Rate Single pulse repetitive pulsing at 1 2 3 4 5 Hz Pulse Duration Nanoseconds 50 ns 100 ns Beam Spot Sizes 2 3 and 4 mm diameter Cooling Method Air coo...

Страница 93: ...dela Corporation AlexTriVantage Laser System Specification Description Dimension 43 H x 16 W x 30 D Weight 290 lbs Voltage and Power 220 230 V 50 60 Hz single phase 4000 VA or 16 A at 230 V 26 A peak Table 6 1 AlexTriVantage System Specifications ...

Страница 94: ...e operation of the laser system The power receptacle for the laser system must meet the following requirements Electrical Requirements USA 208 V Europe 230 V Asia Pacific 200 V Maximum line voltage variation 10 50 60 Hz single phase Rated Current 26 A peak at 230 V 16 A RMS at 230 V Electrical Service For CE Countries 20 A minimum service supported by a 100 A mains For non CE Countries 20 A servic...

Страница 95: ... of the light or sounding of the buzzer Environmental Requirements Before installation 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 Space Sufficient floor space is required for the las...

Страница 96: ...head or the optical fiber to be disturbed resulting in personal injury or physical damage If it becomes necessary to relocate the laser contact Candela Technical Support or your distributor for details Failure to do so may result in personal injuries or damage to the system and may void any warranty Mobile Use The AlexTriVantage Laser System is not designed for mobile use Transport and Storage For...

Страница 97: ...n 05 Confidential 7 1 Chapter 7 Candela Corporation AlexTriVantage Laser System Laser System Packing Lists Accessories and Replacement Parts 7 Topics described in this chapter include Laser Parts and Accessory Kit page 7 2 ...

Страница 98: ...rts and Accessory Kit Description Quantity Part Number Fiber Delivery System 1 7122 00 3908 2mm Handpiece 1 7122 00 3909 3mm Handpiece 1 7122 00 1100 4mm Handpiece 1 7122 00 1101 Distance gauge kit Qty 6 1 7122 00 1099 Footswitch 1 5103 00 0030 Eyewear Alex OD 7 755nm 2 8095 00 0260 Patient Goggles 1 8095 00 0470 Operators Manual 1 8501 00 1800 Candela key ring 1 1301 00 3409 Laser Radiation Wall ...

Страница 99: ...ernal Calibration Procedure 8 Topics described in this chapter include Calibration Schedule page 8 2 Introduction page 8 2 Parts List page 8 2 Internal Calibration page 8 4 Starting the Circuit Calibration Procedure page 8 4 Laser Energy Circuit CAL page 8 4 Final Verification of User Calibration Energy page 8 5 ...

Страница 100: ...ement circuits themselves must be calibrated at least once a year by a qualified service technician The internal energy calibration procedure or Laser Energy Circuit CAL 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 specif...

Страница 101: ...livery of lower or higher fluences and potential burning of patients This procedure must be followed precisely for proper results If the Final verification of User Calibration Energy section fails contact Candela Technical Support for further information Once the Laser Energy Circuit CAL procedure has been started the previously saved CAL parameters will be erased and the Laser Energy Circuit CAL ...

Страница 102: ...lses the laser into an external meter and then into the system s Calport at low and high energies to calculate slope and offset calibration values 1 Put on AlexTriVantage laser safety eyewear Warning The laser will enter the READY mode for the entire calibration procedure 2 Press the Cal Energy Ckt button to begin the Circuit CAL A message will appear on the screen Are you sure you want to calibra...

Страница 103: ...st add the 0 at the end to make it J This will appear as 2 200 on the keypad If the laser software is prompting for the technician to pulse into the Calport and the laser is mistakenly pulsed into the Ophir a PreGain Error may occur If this error or any other error happens restart the procedure 4 The software will prompt the technician with Circuit Cal Successful when it is complete 5 Press the CA...

Страница 104: ...to be repeated If it fails more than once then contact Candela Technical Support for service 6 If the Circuit Calibration is successfully complete without failure the laser can be safely used Table 8 1 Calibration Tables 3mm 5 0 J cm2 Expected Energy 308 J Pulse Ophir Energy J 1 2 3 Average J Percent Difference 3mm 10 J cm2 Expected Energy 616 J Pulse Ophir Energy J 1 2 3 Average J Percent Differe...

Страница 105: ... evidence to date suggests that epidermal lesions can usually be retreated within 4 to 6 weeks Dermal lesion treatments performed after 8 or more weeks have shown the most effective clearance 2 There may be discomfort pain resulting from the treatment 3 Transient edema may occur immediately following laser therapy 4 Occasionally pinpoint punctate bleeding at laser impact sites 5 A white gray disco...

Страница 106: ...t able to objectively assess their own progress photographs provide documented evidence on the course of treatment At each session before and after treatment photographs should be taken under standardized conditions Care should be taken so that photographs are similar in magnification light exposure or flash conditions and color balance Inclusion of a standard color bar in the photograph serves as...

Страница 107: ...1 Applying a Test Dosage Optimum therapeutic energy density is dependent upon the tattoo or pigmented lesion and individual variations that occur from patient to patient For example optimum dosage for the treatment of a tattoo can depend on the origin of the tattoo amateur professional or traumatic the depth of pigment and the patient s skin type To determine the correct therapeutic energy density...

Страница 108: ...ould be adjusted or discontinued Treatment should be at the lowest energy density that produces clearance at the test site s Inappropriate selection of an initial therapeutic energy density may result in choosing a level that is higher than needed and could possible result in hypo or hyperpigmentation or scarring Treatment Tattoos The laser exposure dosage applied to treat tattoos may be in the ra...

Страница 109: ...end of treatment is left to the physician s judgment The factors involved in this decision relate to the clearance or lightening of the tattoo or pigmented lesion and the restoration of normal skin color and texture Often the decision to end treatment is arrived at jointly between the physician and the patient or parents or guardians as applicable Treatment should cease when the tattoo or pigmente...

Страница 110: ...B 4 Confidential 8501 00 1800 Revision 05 Candela Corporation AlexTriVantage Laser System ...

Страница 111: ...plied following 1 to 2 days of antibiotic ointment treatment The use of sunblock 15 or greater on a regular basis may also prove helpful Makeup The use of makeup during the first 7 10 days after treatment is not recommended The removal of makeup can disrupt the skin increasing the chance for infection Other Recommendations Following treatment excessive perspiration to the treated area may cause ti...

Страница 112: ...C 2 Confidential 8501 00 1800 Revision 05 Candela Corporation AlexTriVantage Laser System ...

Страница 113: ...se in commercial and industrial locations A portion of IEC 60601 1 2 deals with measurements of unwanted radio frequency emissions generated from a product Both radiated emissions radiated through the air and conducted emissions conducted into the AC Mains are measured Radiated and conducted emissions from a product have been known to interfere with the performance of other equipment in the vicini...

Страница 114: ...ct with Class 3R aiming beam per EN60825 1 Laser Hazard Classification The Candela Laser System is a Class II medical device per FDA 21 CFR 878 4810 and a Class 2b Rule 9 non invasive active device according to Annex IX of Directive 93 42 EEC and Canadian Health Ministry Classification The AlexTriVantage complies with 21 CFR 1040 10 and 1040 11 except for deviations pursuant to Laser Notice No 50 ...

Страница 115: ... handpiece cleaning 4 3 I indications for use 1 3 intended audience vii K keylock switch 2 8 L Laser Aperture i x 2 6 2 17 laser system cleaning the distance gauge 4 3 cleaning the exterior 4 3 cleaning the handpieces 4 3 cleaning the lens 4 3 connections 2 6 controls 2 6 front panel 2 5 maintaining 4 2 troubleshooting 5 2 laser treatment 3 3 before you begin 3 2 performing 3 2 lens cleaning 4 3 l...

Страница 116: ...toos treatment of 1 4 treating lesions 1 4 tattoos 1 4 the patient B 1 treatment guidelines B 1 performing laser 3 2 post treatment care C 1 pre treatment visit A 1 troubleshooting the laser system 5 2 troubleshooting table 5 2 U use indications for 1 3 W warnings 1 5 water cooling specifications 6 6 ...

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