OPERATOR’S MANUAL
SculpSure
®
Laser System
operator
Page 1: ...OPERATOR S MANUAL SculpSure Laser System operator ...
Page 2: ......
Page 3: ...5 Carlisle Road Westford MA 01886 USA cynosure com t 978 256 4200 t 800 886 2966 f 978 256 6556 SculpSure Operator s Manual P N 850 7026 000 Rev 6 Updated November 2016 ...
Page 4: ...ginal SculpSure software installed on your SculpSure system and any SculpSure software upgrades installed on your SculpSure system by authorized representatives of Cynosure Inc Cynosure are owned by Cynosure You may not tamper with this software including unauthorized upgrades disclose it to third parties or use it for any purpose other than running your SculpSure system Cynosure does not grant yo...
Page 5: ...r 3 Site Preparation 25 Spatial Requirements 25 Electrical Requirements 25 Operating Environment 26 Storage and Transport Requirements 26 Transporting the Laser 27 Chapter 4 System Description 29 Components 29 Delivery System 35 Pager System 35 PAC Key 36 Pause Button 37 Applicators How to Remove How to Attach 38 Chapter 5 Software Description 49 Common Icons and Buttons 50 Operations Screens 52 T...
Page 6: ...r Filter Maintenance 74 Adding Coolant 75 Care and Handling System Exterior 77 Power Verification 79 Troubleshooting 80 Fault Codes Descriptions and Possible User Actions 82 Chapter 9 Customer Support 91 Direct Purchase Warranty 91 Distributor Purchased Warranty 91 Warranty Claims 91 Installation 91 Customer Service 92 Items Commonly Ordered 92 Appendix A Service Procedures 93 System Battery Repla...
Page 7: ...pplicator Optical Fiber Applicator per EN60601 2 22 Located on System Filling per IEC TR 60878 Located on system Remote Interlock Connector per EN60601 2 22 Located on System WEEE symbol per EN50419 Located on System and Applicator Manufacturer per EN ISO 15223 1 Located on System and Applicator Attention consult accompanying documents Located on System Non ionizing Radiation Located on System Dat...
Page 8: ...Manual must be observed when installing operating moving or servicing the system CAUTION The Applicator contains delicate optical components that may suffer severe damage if dropped jarred or bumped When not in use the Applicator should be securely maintained Cynosure is not responsible for damage caused by dropping abuse misuse or negligence of the Applicator CAUTION Do not use any organic solven...
Page 9: ... law of the state in which he she practices to use or order the use of the device Federal law and some international laws also require that this device be utilized under the direction of a physician This device should only be used by healthcare professionals authorized under US state or international laws to treat clients All persons treating clients with this device should determine whether they ...
Page 10: ...ency disorders including HIV infection or AIDS or use of immunosuppressive medications Is currently taking antiplatelets thrombolytics anti inflammatories or anticoagulants including but not limited to the heavy use of aspirin i e greater than 81 mg per day Has a coagulation disorder Has had a previous procedure or surgery in the treatment area that may have resulted in decreased sensation scar fi...
Page 11: ...to the device Observation to the instructions for use is the supposition for proper usage and handling of the system so as to ensure operator and client safety CAUTION Use of controls adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure To avoid these hazards the precautions described in this Operator s Manual must be observed when i...
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Page 13: ...the system should be aware of the requirements of AS NZS 2211 1 Safety of Laser Products Part 1 Equipment Classification Requirements and User s Guide Customer and operator agree that it is their sole responsibility to fully understand and comply with local state and federal laws rules and regulations in the use of this system WARNING Cynosure Lasers must be used with accessories and cables as app...
Page 14: ...le laser light radiation that can cause serious eye damage with direct or even indirect optical contact WARNING Lasers can cause eye injury Never perform any set up or maintenance procedures on the SculpSure Laser that bypass the safety features or lead to greater exposure beyond normal output CAUTION Do not operate the Applicator within 22 cm of the eyes Injury may result CAUTION Do not use any o...
Page 15: ...rial When the SculpSure Laser is used the following precautions should be taken to prevent a laser induced fire Use non flammable substances for uses such as anesthesia skin preparation and cleaning instruments Keep a minimum of combustible materials e g alcohol in the treatment room Ensure that the System and ancillary equipment are working properly before beginning a procedure Never direct the l...
Page 16: ... be aware of the potential hazards of the System output and should take the proper safeguards as described in this Operator s Manual High voltages are present inside the SculpSure Laser and any light emitting device may cause injury if used improperly The SculpSure Laser has been designed and validated in accordance with this Operator s Manual As with any light based device never look directly at ...
Page 17: ...ards and hands on experience Treatment Safety Never look directly at the light coming from the light emitting end of the Applicator as this may cause eye injury A well trained staff fosters safety Education for those being treated is important and information about the nature and expectations of the treatment should be provided Room Safety Identify the treatment room clearly For any laser treatmen...
Page 18: ...te laser warning signs in prominent locations where the laser is in use Restrict entry to the treatment room when the system is in use Allow access to the treatment room only to those personnel both essential to the procedure and well trained in system safety Never operate the system in the presence of flammable liquids such as alcohol or flammable anesthetics such as ether Moisten combustible mat...
Page 19: ...s to prevent its misuse or unintentional activation All personnel who operate the system or assist during treatment should be familiar with these safety features Arm umbilical management system Emergency laser stop Keyswitch Power button circuit breaker Remote interlock Casters locking Casters positional lock Pause button ...
Page 20: ...kin Delayed Ready Mode As required by the Center for Devices and Radiological Health of the U S Food and Drug Administration and International Standards EN60601 2 22 and EN60825 1 there is a 3 second delay from the time Ready mode button is pressed and lasing begins This delay during which the laser beeps three times provides time for the operator to be prepared before treatment begins If the syst...
Page 21: ... place On the top of the back casters is a locking lever To lock the casters press down on the front of the lever To release the casters push the top of the lever into its original horizontal position Front casters are positional locking casters Pause Button A hard wired Pause button is located on the front of the system ...
Page 22: ...SculpSure Laser comes with a series of required device safety labels Be sure that all personnel are familiar with these labels and their meanings Refer to Glossary of Symbols in the front of the manual for other symbols that may be screened onto the device Applicator Labeling ...
Page 23: ...850 7026 000 Rev 6 SculpSure by Cynosure Page 23 of 102 Console Labeling Rear of Console Rear Panel inside Reservoir Door near Applicator Connectors and System screens Inside Door ...
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Page 25: ...bs 118 Kgs Electrical Requirements Please consider the following electrical requirements before installing the Laser AC Line Power Requirements Laser Voltage 200 240V Single Phase Current 20A Frequency 50 60Hz The laser plug is a NEMA L6 20P the receptacle is NEMA L6 20R Power receptacles must be grounded and within 10 feet of the laser site The laser unit should not share a power line with other ...
Page 26: ... that there is at least 20 50cm between the unit and the wall to allow proper air flow Minimum entryway width 26 W x 80 H Storage and Transport Requirements To maintain the Laser properly during storage and transport follow these requirements Keep the ambient temperature from 40 to 110 F 4 to 43 C When storing or transporting the laser in temperatures less than 40 F 4 C the laser coolant must be d...
Page 27: ...oting position when moving the workstation over long distances such as from room to room within a facility Locking the front casters will improve stability while the system is in motion Move the workstation at a slow pace keeping in mind that quick movement or sudden changes in direction could cause system instability Inclines When moving the workstation up or down inclines always travel in line w...
Page 28: ...g the Arm and for mounting the display into shipping position When the system is loaded into the vehicle it should be strapped to a structural support within the vehicle with all four casters and wheels locked The strap should be located centrally along the console and the enclosure protected from the strap using padding or blankets Disposal of Waste Electrical and Electronic Equipment To comply w...
Page 29: ...nts of the SculpSure Laser including the delivery system The SculpSure touch screen Display controls the settings All Laser components are described in the following pages of this chapter Emergency laser stop Air filter on two sides of the System Reservoir module behind user accessible door Four Applicators with corner LED lights Pause Button Handle ...
Page 30: ...e by Cynosure Page 30 of 102 Components continued Arm umbilical management system Display 270 swivel Handle USB ports Keyswitch Power cord Power button circuit breaker Remote interlock Casters locking Casters positional lock Dock ...
Page 31: ...ector if this feature is not being used Locking Casters The back casters of the Laser can be locked into place On the top of the back casters is a locking lever To lock the casters press down on the front of the lever To release the casters push the top of the lever into its original horizontal position The front casters are positional locking casters These casters can be engaged to roll but not p...
Page 32: ...850 7026 000 Rev 6 SculpSure by Cynosure Page 32 of 102 Applied Parts of SculpSure Applicator Applicator Sapphire ...
Page 33: ...re by Cynosure Page 33 of 102 Frames sold in multiples Bridge Connectors P N 100 7026 133 P N 100 7026 134 P N 100 7026 135 P N 100 7026 136 P N 100 7026 137 P N 100 7026 138 P N 100 7026 139 P N 130 7026 116 Package of eight 8 ...
Page 34: ...850 7026 000 Rev 6 SculpSure by Cynosure Page 34 of 102 Belts sold in multiples Triple Belt P N 100 7026 145 Single Belt P N 100 7026 144 Single Belt Short P N 100 7026 146 ...
Page 35: ...lient treatment area Pager System The pager system is an accessory to SculpSure The pager system is comprised of two components the transmitter and the pager Cynosure service technicians will link the pager to the transmitter Transmitter The transmitter is intended to be used by the client for non emergency contact to the treatment staff The transmitter should be used for casual notifications such...
Page 36: ...r on one end Insert a loaded PAC Key into a USB port in the rear of the SculpSure system Multiple PAC Keys can be installed in the USB ports SculpSure will automatically deplete PACs from one installed PAC Key to another For example if one PAC Key has three 3 PACs remaining and another PAC Key has a full 100 PACs both PAC Keys can be installed in the USB ports The system will deplete the 3 PACs fi...
Page 37: ... as shown Pause button may be hung on the Arm when not in use Keep pause button within easy client access during treatment See arrow at right When the pause button is pressed the treatment session will pause The client should then press the transmitter button to alert the treatment staff that the session has been paused Refer to instructions on the Pager System in this Chapter ...
Page 38: ...ve How to Attach The following information is based on the Applicator Quick Reference Guide P N 850 7026 600 included with each Applicator Removing an Applicator STEP 1 Unplug the system from the AC power outlet Lock the two Locking Casters STEP 2 Lift and remove the console cover ...
Page 39: ... the connections as shown to absorb any dripping Chiller Fluid Note E Laser Fiber Cap F System Fiber Cap Each Applicator has four connections A Female Coolant B Male Coolant C Electrical and D Laser Fiber IMPORTANT If an Applicator is removed from the System and is not replaced install the System Fiber Cap in the opening as shown F ...
Page 40: ... CAUTION Do not touch or contaminate the exposed laser fiber at the Applicator s connection point Keep the laser fiber capped or installed in the system at all times Contamination of the laser fiber may result in damage to the system STEP 6 IMPORTANT Carefully unscrew and remove the Laser Fiber without touching the Fiber end Immediately cap the Fiber end with the attached Fiber Cap as shown Ensure...
Page 41: ...drip from the connector Wipe Fluid as required then discard paper towel STEP 8 Remove the Male Coolant connector NOTE it is normal for some Chiller Fluid to drip from the connector Wipe any visible Fluid then discard paper towel STEP 9 Remove Umbilical Housing by grasping the Housing and pulling it off using a slight up and down rocking motion ...
Page 42: ...42 of 102 STEP 10 Push up on the Release Latch STEP 11 With the Release Latch up lift the Umbilical Roller release the Latch and gently disengage the Umbilical as shown STEP 12 Loosen do not remove the twist knob Turn the plate to vertical as shown ...
Page 43: ...sure Page 43 of 102 STEP 13 Lift the Applicator Mounting Block and pull away from the housing as shown STEP 14 Pinch the two finger latches on the Applicator and release the Applicator from the Tray Applicator removal process is complete ...
Page 44: ...r outlet Lock the two Locking Casters Fit the Applicator head into the Tray STEP 2 Insert the Applicator Mounting Block into keyhole in back panel and push down to secure to the panel STEP 3 Push up on the Release Latch lift the Umbilical Roller release the Latch and gently insert the Umbilical between the Rollers as shown ...
Page 45: ...housing and firmly hand tighten the knob STEP 6 Each Applicator has four connections A Female Coolant B Male Coolant C Electrical and D Laser Fiber E Laser Fiber Cap DO NOT REMOVE CAP UNTIL INSTRUCTED STEP 7 Insert the Male Coolant connector NOTE It is normal for some Chiller Fluid to drip during insertion Use a paper towel to wipe Fluid as required Discard paper towel ...
Page 46: ...e by Cynosure Page 46 of 102 NOTE If the mechanism is locked and the Fitting won t insert press latch to disengage as shown STEP 8 Insert the Female Coolant connector NOTE If mechanism is locked press latch to disengage as shown ...
Page 47: ... or contaminate the exposed laser fiber at the Applicator s connection point Keep the laser fiber capped or installed in the system at all times Contamination of the laser fiber may result in damage to the system STEP 10 Carefully insert the Laser Fiber without touching the Fiber end If the Fiber end becomes soiled contact Customer Service before using the laser STEP 11 Insert the Electrical Conne...
Page 48: ...850 7026 000 Rev 6 SculpSure by Cynosure Page 48 of 102 STEP 12 Ensure all fittings are in place STEP 13 Install Umbilical Cover STEP 14 Install Console Cover Applicator Installation is complete ...
Page 49: ...49 of 102 Chapter 5 Software Description This section of the manual describes the software screens and screen elements Consult SculpSure Clinical Reference Guide for details on the proper use of the Applicators Belts Frames and treating the client ...
Page 50: ...26 000 Rev 6 SculpSure by Cynosure Page 50 of 102 Common Icons and Buttons Shopping cart indicates number of PACs available Advance to cool Timer toggle Back Tools Consult Operator s Manual Standby Start Stop ...
Page 51: ... is Active Applicator Up and Down energy level adjustors These arrows adjust the energy in increments of 0 05 W cm2 The 4 in this example indicates Applicator 4 Applicators are unlinked Cynosure access only System diagnostics For exporting binary log files to a USB memory stick Remote access button Press to allow remote service technician access ...
Page 52: ...850 7026 000 Rev 6 SculpSure by Cynosure Page 52 of 102 Operations Screens NOTE Not all screens are shown At start up the system performs an automatic self test Progress Bars Build Sustain ...
Page 53: ... in fields of basic client demographic information and then click the bottom check box to proceed Select desired treatment area Observe blue and white Consult Operator s Manual icon at right of screen Only treat areas that are in the Indications For Use section of this Manual ...
Page 54: ...ked System is waiting for Applicators to be attached to Frames and in proper contact with the client s skin Applicator has been removed from the dock as indicated by a solid yellow rectangle with a flashing yellow border Applicator is in the process of being installed into a Frame ...
Page 55: ... and is in full contact with the skin In the above scenario a second Applicator has been installed correctly but the first Applicator has lost skin contact Before starting treatment the operator must ensure all chosen Applicators are in proper contact with the skin The next screen in this manual demonstrates proper contact of two Applicators ...
Page 56: ...the skin One to four Applicators may be used for treatment In this example two Applicators are being used To start treatment press the Start button on upper right of screen Do not attempt to add a docked Applicator to the treatment site after treatment has started The system will automatically disable that Applicator and an X will display in its position on the screen ...
Page 57: ...Cynosure Page 57 of 102 Note the progress bars which appear above the timer Treatment has started and is 13 seconds into the 4 minute Build mode Upper right button is now Stop Press Toggle to change from time elapsed to time remaining ...
Page 58: ...for an automatic 40 seconds of cooling in Build mode After the advance to cool button is pressed from the previous screen the energy will drop by 0 1 W cm2 and the system will automatically provide 40 seconds of skin cooling 31 seconds elapsed is shown as cooling is in progress Once cooling is completed the system will prompt the user to press the Start button at top right ...
Page 59: ...mpleted the system will automatically resume the Sustain mode To Terminate Treatment To terminate treatment press the back button A Confirm Early Treatment Termination dialog box will appear Select Yes or No Yes terminate treatment No continues treatment NOTE PACs in use will be consumed if the treatment is terminated when the system reaches 2 two minutes or longer in Sustain mode If treatment is ...
Page 60: ... of contact If contact is restored within 30 seconds the Applicator GUI will return to green and the system will automatically restart If contact has been lost in excess of 30 seconds then 4 minutes and 30 seconds of cooling will automatically start A Cool down in progress message will be displayed on screen Re position the Applicator for proper contact at this time After the 4 minutes and 30 seco...
Page 61: ...n at right the system is 1 07 into the Build mode Treatment in Sustain Mode After Loss of Contact After the 4 minute Build mode treatment automatically proceeds to Sustain mode where the treatment was interrupted System will continue in Sustain mode to complete the remainder of the 21 minutes of treatment Note that Build progress bar is now gray inactive ...
Page 62: ... synchronized and will adjust together If an operator wants to independently adjust the energy in each Applicator the Applicators must be rendered unlinked Applicators may be rendered unlinked either in the dock or on the client NOTE If the operator wishes to unlink then the desired Applicators must be unlinked before the start of treatment To unlink the Applicators select the Tools button Next se...
Page 63: ...the unlink feature simply touch the inside box of the desired Applicator For example touch the region where the energy reading of 1 10 W cm2 is displayed That Applicator s blue shade signifies it is now unlinked and its energy may now be adjusted independently of the other Applicators Observe the Applicator s are unlinked symbol on the top left of the screen Note that the remaining Applicators rem...
Page 64: ...second Applicator simply touch inside the Applicator s center box and it will turn blue That Applicator s energy can now be independently adjusted as well To restore the link simply touch the unlinked Applicators center boxes This will allow for synchronized adjustment ...
Page 65: ...ck is optional Unless the operator locks it the system will be unlocked To lock the system simply press the lock icon The system will remain locked until it is unlocked To Unlock the System To unlock the system select the lock icon and type the PIN NOTE The default PIN is 01886 This PIN is always active and will function if the operator forgets their custom PIN To Change the PIN To change the PIN ...
Page 66: ... 102 The default PIN of 01886 will appear in the PIN box To change it touch the PIN box located below ENTER NEW PIN Keypad is now active Set the new desired PIN There is a one 1 character minimum PIN Next select the check box then select the Back button ...
Page 67: ...he new PIN Changing PIN is now complete To Verify the Current PIN For a reminder of the current PIN follow the first few steps of To Change a PIN section The current PIN will appear in the ENTER NEW PIN box Use the back button to back out of the screen with no changes being made ...
Page 68: ...re Page 68 of 102 To Change Onscreen Languages To view and or select the languages supported by the System select the Tools icon then press System Settings Next click the language selector menu Select the language of choice English is shown ...
Page 69: ... state System Coolant Distilled water or Cynosure Chiller Fluid Actuator Contact sensors on Applicator Beam Divergence 92 Nominal Ocular Hazard Distance NOHD 22 cm Corneal Maximum Permissible Exposure MPE MPE 1070 J m2 1 sec NOHD Electrical Power 200 240 V 50 60 Hz Single phase Electrical Service Requirement 20A Max Electrical Power Input 1800 VA Type of Protection Against Electric Shock Class 1 E...
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Page 71: ...Ensure power switch is in OFF position Plug prong end of power cord into an appropriate wall outlet NOTE Do not position the SculpSure Laser System such that it is difficult to disconnect the mains connection NOTE International customers voltage requirements vary per region Check with your Distributor for details NOTE System can be disconnected from the mains by disconnecting the power cord from t...
Page 72: ...the desired Build and Sustain energy levels 3 Press the standby ready button to change the system from standby to ready mode and to begin treatment Laser Shutdown 1 Verify that the laser is in standby mode 2 Turn the key to the off position 3 Remove the key and then safeguard it to prevent access by unauthorized users IMPORTANT In an emergency situation only use the emergency stop button to immedi...
Page 73: ...t of a system failure the system and or Applicator s should be returned to Cynosure for repair by Cynosure factory trained technicians All returns must be accompanied by a Return Material Authorization RMA Number Contact Cynosure s Customer Service at 1 978 256 4200 toll free in the USA 800 886 2966 or email serviceadmin cynosure com to obtain the RMA Number If the System or Applicator is under wa...
Page 74: ...very 3 6 months The air filters should be replaced annually Turn off the SculpSure System Gently pull on the finger loop of the filter until the filter slides completely out Inspect and vacuum the filter as required If the filter is damaged it should be replaced with a new one Re install the filter with the soft side of the filter frame facing outward as shown Slide the filter into the holder unti...
Page 75: ...mpt will indicate low fluid Add either distilled water or Cynosure Chiller Fluid only Turn off the SculpSure System Open the access door by pushing on the indentation as shown at right Unscrew and tilt out the reservoir access panel While holding the panel open twist and remove each reservoir cap as shown Both reservoirs should be checked and filled as required ...
Page 76: ...culpSure by Cynosure Page 76 of 102 Add the distilled water or Chiller Fluid only Twist the cap back onto the fill port close the reservoir access panel secure screw and close the access door by pushing on the indentation ...
Page 77: ...and Frame for at least 15 minutes in 70 isopropyl alcohol isopropanol such as Steris Septihol Sterile Alcohol Solution according to the manufacturer s instructions 4 Remove the Belt and Frame from the cleaning solution and allow the parts to dry completely for at least 15 minutes before use Cleaning Pause Button 1 Clean the Pause Button after each use 2 After use wipe the client contacting surface...
Page 78: ...nfecting Applicator CAUTION Do not submerge the Applicator in any fluid Damage may result 1 After use wipe the client contacting surfaces of the Applicator with a clean wipe dampened in 70 isopropyl alcohol isopropanol such as Steris Septihol Sterile Alcohol Solution according to the manufacturer s instructions Discard the soiled wipe 2 Next dampen a clean wipe with 70 isopropyl alcohol isopropano...
Page 79: ...ween annual calibrations the output power can be checked for accuracy as follows Required Equipment and Accessories Calibrated Ophir L100C BB 120 SH Y meter head Calibrated Ophir NOVA ll or VEGA power energy meter Cynosure power meter fixture assembly 706 7026 048 Console calibration fixture 706 7026 027 with 807 7026 010 fiber Coolant jumper 706 7026 018 to check diode output Procedure 1 Set the ...
Page 80: ...e faults can be handled by the customer via corrective actions as explained onscreen Other faults require a trained Cynosure service technician to resolve If any suggested corrective action does not work please contact Service Contact information is listed on page 92 The F120 Fault is likely caused when the software was not installed correctly or has been corrupted The operator is being instructed...
Page 81: ...ll Cynosure Service The Service button seen on the screen is for the service technician to utilize not the customer If the F512 Fault occurs allow system to cool then retry or select the X to disable the faulty Applicator and continue If problem persists call Cynosure Service The Service button seen on the screen is for the service technician to utilize not the customer ...
Page 82: ...rvice F301 Chiller Temperature Low Retry If problem persists call Service F302 Chiller State Fault Retry If problem persists call Service F303 Manifold Temperature Fault Allow system to cool and retry If problem persists call Service F304 Heat Exchanger Over Temperature Allow system to cool and retry If problem persists call Service F305 HCPS Readback Fault Retry If problem persists call Service F...
Page 83: ...ue to operate without the disabled applicator or restart the system using the key If problem persists call Service F424 Applicator 1 Photodiode Shorted Continue to operate without the disabled applicator or restart the system using the key If problem persists call Service F425 Applicator 2 Photodiode Shorted Continue to operate without the disabled applicator or restart the system using the key If...
Page 84: ...fiber is fully seated in bulkhead connector Retry or Disable faulty Applicator and continue If problem persists call Service F523 Laser Diode 4 Fiber Fault Make sure fiber is fully seated in bulkhead connector Retry or Disable faulty Applicator and continue If problem persists call Service F524 Chiller Valve 1 Flow When Not Expected Retry or Disable faulty Applicator and continue If problem persis...
Page 85: ... key If problem persists call Service F120217 Laser Diode 2 Digital Potentiometer Failure Continue to operate without the disabled applicator or restart the system using the key If problem persists call Service F120218 Laser Diode 3 Digital Potentiometer Failure Continue to operate without the disabled applicator or restart the system using the key If problem persists call Service F120219 Laser Di...
Page 86: ...system using the key If problem persists call Service F120901 Software Fault Restart the system using the key If problem persists call Service F120904 Software Fault Restart the system using the key If problem persists call Service F120905 Software Fault Restart the system using the key If problem persists call Service F120906 Software Fault Restart the system using the key If problem persists cal...
Page 87: ...le faulty Applicator If problem persists call Service F140114 Applicator 3 UTF Re asserted Retry or Disable faulty Applicator If problem persists call Service F140115 Applicator 4 UTF Re asserted Retry or Disable faulty Applicator If problem persists call Service F140200 Applicator Self Test Failed Continue to operate without the disabled applicator or restart the system using the key If problem p...
Page 88: ... If problem persists call Service F140234 Applicator 3 No Serial Number Continue to operate without the disabled applicator or restart the system using the key If problem persists call Service F140235 Applicator 4 No Serial Number Continue to operate without the disabled applicator or restart the system using the key If problem persists call Service F140236 Applicator 1 Software Corrupted Continue...
Page 89: ...stem using the key If problem persists call Service F170901 Software Fault Restart the system using the key If problem persists call Service F170902 Software Fault Restart the system using the key If problem persists call Service F170903 Software Fault Restart the system using the key If problem persists call Service F170904 Software Fault Restart the system using the key If problem persists call ...
Page 90: ...he key switch is off Turn the key switch to the on position Laser does not start Remote interlock is not in place Install remote interlock at rear of system where USB ports are located Laser does not start E Stop button is depressed Turn and release the E Stop button and restart the system Applicator LED is blinking Applicator is not in proper contact with the skin Re seat the Applicator on the sk...
Page 91: ...mation Warranty Claims If merchandise is damaged and you want to return the merchandise for repair or replacement please be aware of the following You should make the claim as soon as possible Before returning merchandise obtain prior approval from Cynosure Cynosure will provide shipping instructions Returned merchandise must be sent insured and prepaid The cost of shipping is the responsibility o...
Page 92: ...l service cynosure com If there is a question regarding clinical information call Cynosure Clinical support Call 1 844 365 5060 Email clinical cynosure com Items Commonly Ordered Applicator one each S100 7026 100 LuxLotion case of 9 bottles 1620 0162 Single Belt 6 per pack 100 7026 144 Single Belt Short 6 per pack 100 7026 146 Triple Belt 4 per pack 100 7026 145 Pager Transmitter 170 7026 011 Page...
Page 93: ...ttery failure to take proper anti static precautions could damage the laser system 2 Using a forefinger and thumb grab the edge of the battery through the opening in the battery mount Push the battery toward the mounting tab and then pull away from the battery mount 3 In the same manner install a new battery by inserting it back into the holder with the negative side of the battery facing up 4 Rep...
Page 94: ...priate fuse FUSES VALUES MFG TYPE and SPECIFICATIONS DESCRIPTION CYNOSURE PART NUMBER F1 F4 F6 F7 5 0 Amp Schurter 250VAC 300VDC 5 0A SPT 5 mm x 20 mm IEC Standard Fuse F1 26V IGBT PAGER PWR F4 SW UN SW 26V F6 FAN POWER F7 26V 463 0111 995 F5 8 0 Amp Schurter 250VAC 300VDC 8 0A SPT 5 mm x 20 mm IEC Standard Fuse F5 WATER PUMP PWR 463 0111 998 Cables The following table lists cables used on the sys...
Page 95: ...pSure system ON and the system will go through self check when it comes to the standby screen go to the Utilities button and click on the Service icon 3 Enter the Cynosure provided service access code 4 Once the system enters the SculpSure Service console click on the self check button and perform the self check on the system 5 After successful completion of the self check Click on the System cali...
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Page 97: ... in nearby electronic equipment RF emissions CISPR11 Class A The SculpSure is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to public low voltage power supply network that supplies buildings used for domestic purpose provided the following warning is heeded IMPORTANT This equipment system is intended for use by he...
Page 98: ...e IEC 61000 4 5 1 kV for line to line 2 kV for line to earth 1 kV for line to line 2 kV for line to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycle 70 Ut 30 dip in Ut for 25 cycle 5 Ut 95 dip in Ut...
Page 99: ...and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies NOTE 2 Thes...
Page 100: ...23 0 1 0 38 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For Applicators on SculpSure the following additional separation distances are needed in the 35MHz to 50MHz range Refer to the below table for the separation distance from SculpSure Applicators Rated maximum output power of transmitter Separation distance according to frequency of transmitter 35MHz to 50MHz d 3 5 V1 P W...
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