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Summary of Contents for Cynosure Cynergy
- Page 1 Cynergy ™ OPERATOR MANUAL 850-1065-000, Rev. 6 CYNOSURE ® 5 Carlisle Road, Westford, MA, 01886, USA Phone: 978-256-4200 www.cynosurelaser.com...
- Page 2 Singapore 787600 Telephone: 65-9988-4565 Telefax: 65-6853-4309 ™ Cynergy is a trademark of Cynosure, Inc. ® Cynosure is a registered trademark of Cynosure, Inc. This manual is intended for both U.S. and international distribution. © 2005 Cynosure, Inc. All rights reserved.
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Page 3: Table Of Contents
Figure 1B–Device Labels Used ................15 Section 3 Site Preparation ....................17 Spatial Requirements ....................17 Electrical Requirements ....................17 Environmental Requirements..................18 Storage and Transport Requirements................18 Disposal of Waste Electrical and Electronic Equipment ..........18 Cynergy Operator Manual 850-1065-000, Rev. 6 Page 1 of 78... - Page 4 Utility Screen ....................31 Figure 5F–Utility Screen ..................31 Option Screen ....................33 Figure 5G–Option Screen .................33 System Specifications ....................34 General Specifications ..................34 Fluence Specifications ....................35 Cynergy PDL ....................35 Cynergy YAG ....................36 Cynergy MultiPlex Option................37 Page 2 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
- Page 5 Indications, Contraindications and Adverse Effects–PDL ...........48 Indications......................48 Contraindications ....................48 Adverse Effects....................48 Patient Selection–PDL....................48 Pretreatment Recommendations–PDL................49 Determine Suitability..................49 Inform Patient About the Treatment ..............49 Photographs ......................49 Treatment Recommendations–PDL................50 Minimizing Adverse Effects ................50 Setting Energy Level ..................50 Cynergy Operator Manual 850-1065-000, Rev. 6 Page 3 of 78...
- Page 6 Figure 6B–Detaching/Inserting Dye Inject Bottle ..........58 Troubleshooting ......................59 Faults.........................59 Fault Code Table....................59 Self Test ......................61 Troubleshooting Chart ..................62 Transferring Diagnostic Data................63 Figure 7A–USB Access Panel Location ............63 Figure 7B–USB Slot Location ................64 Page 4 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
- Page 7 Calibrating the Resonator Port, YAG ................69 Calibrating the Resonator Port, PDL ................70 Calibrating the Cal Port, YAG..................71 Calibrating the Cal Port, PDL..................72 Appendix B Electromagnetic Compatibility..............73 Appendix C Declaration of Conformity ................77 Cynergy Operator Manual 850-1065-000, Rev. 6 Page 5 of 78...
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Page 8: Glossary Of Symbols And Abbreviations
Glossary of Symbols and Abbreviations The following symbols and abbreviations may be used on the Cynergy laser and/or in this manual. Symbols Declaration of Conformity to Optical Fiber Applicator Medical Device Directive 93/42/EEC per EN60601-2-22: 1996 CE Mark to Directive 93/465/EEC... -
Page 9: Introduction
CAUTION: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. ® Thermokinetic Selectivity and TKS are registered trademarks of Cynosure, Inc. / Cynergy with Multiplex is a trademark of Cynosure, Inc. Cynergy Operator Manual 850-1065-000, Rev. - Page 10 This page has been intentionally left blank. Page 8 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
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Page 11: Equipment Safety
♦ All persons in the room during treatment must wear the protective eyewear recommended by Cynosure. See “System Specifications” starting on page 34 for recommendations. ♦ Never look directly into the handpiece, fiber or fiber opening, even while wearing protective eyewear. -
Page 12: Electrical Hazard
The laser system uses high voltage. Do not open the protective panels unless you are trained and authorized to do so. Chemical Hazard The Cynergy laser uses a dye medium. Handle the dye with care, both to protect against toxicity and against staining. Operators should follow these precautions: ♦... -
Page 13: Laser-Induced Fire Hazard
CAUTION: The Cynergy laser should not be used adjacent to, or stacked with, other equipment other than the Cynergy PL system. If the laser must be used adjacent to, or stacked with other equipment, then observe the laser in its configuration to verify that operation is normal. -
Page 14: Laser Safety Features
This delay, during which there is an audible beep and the ready key is lit, provides time for personnel to prepare before the beginning of treatment. Page 12 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 15: Automatic Shutdown Feature
“Troubleshooting,” starting on page 59. Remote Interlock Cynosure provides a remote interlock circuit that can connect to a door switch of a treatment room. When the remote interlock is wired in series with a door switch, the laser automatically shuts down if anyone enters the treatment room. Contact Cynosure for detailed instructions on how to implement this function. -
Page 16: Device Labels
Device Labels The Cynergy laser comes with a series of required safety labels. Be sure that all personnel are familiar with these labels and their meanings. Figure 1A–Device Labels in Position Page 14 of 78 850-1065-000, Rev. 6 Cynosure, Inc. - Page 17 Figure 1B–Device Labels Used Cynergy Operator Manual 850-1065-000, Rev. 6 Page 15 of 78...
- Page 18 This page has been intentionally left blank. Page 16 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
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Page 19: Site Preparation
When preparing the laser site, operators should consider the spatial, electrical, environmental, transportation and storage requirements of the laser unit. Spatial Requirements The Cynergy and Cynergy III systems, which include the Cynergy Pulse Light (PL) system, have the following dimensions: Cynergy III... -
Page 20: Environmental Requirements
When storing or transporting the laser in temperatures less than 40° F (4° C), the laser coolant system must be drained. This is a highly complex process and should be performed by a trained service technician. Please contact Cynosure Customer Service, as detailed on page 66 to arrange for a service call. -
Page 21: Laser Description
This section of the manual gives a general description of the laser including the system’s specifications. Main Components Refer to Figures 2A and 2B to identify the main components of the laser system. Figure 2A–Main Components, Front Cynergy Operator Manual 850-1065-000, Rev. 6 Page 19 of 78... - Page 22 Figure 2B–Main Components, Inside Front Door Page 20 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
- Page 23 Figure 2C–Main Components, Rear View Cynergy Operator Manual 850-1065-000, Rev. 6 Page 21 of 78...
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Page 24: Key Switch
ON ( | ) and OFF (○). To turn the laser on, insert the key and turn the key switch to the start position. Always remove the key after use to prevent access by unauthorized users. Page 22 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 25: Handpieces And Delivery Optical Fiber
Figure 3. Then disconnect the handpiece electrical cable by pulling it from the handpiece. Connect the new handpiece, and then reconnect the handpiece electrical cable. Be sure to calibrate the laser before initiating treatment with a new handpiece. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 23 of 78... -
Page 26: Trigger Switches
The Foot Switch, a pneumatic switch that reduces the chance of electrical hazard in a wet environment. To connect the foot switch, insert the foot switch into the footswitch port on the rear of the laser. See Figure 2C. Page 24 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 27: Front Control Panel
WARNING: Failure to keep the Cal Port window clean may result in incorrect fluence leading to patient injury. Display The display is at the center of the user interface and consists of a high-resolution color display with a touch screen. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 25 of 78... -
Page 28: Display Screens
Display Screens Home Screen After the laser is turned on, the computer initializes and displays the Cynosure logo. After the system completes a diagnostic routine, the Home Screen is displayed. From the Home Screen menu, the user can choose the PDL laser, the YAG laser, the Cynosure MultiPlex function, a Utility program or a Database of laser treatment parameters. -
Page 29: Treatment Screens
The treatment screens are designed so that the user can see at a glance which wavelength has been chosen. For example the YAG screen, Figure 5C, uses blue fields with white text, while the PDL screen uses the opposite—white fields with blue text. Figure 5C–YAG Screen Cynergy Operator Manual 850-1065-000, Rev. 6 Page 27 of 78... -
Page 30: Treatment Screen Elements
300 ms depending on the laser. See, “System Specifications,” starting on page 34 for further information. To increase the pulse width, press the ( ) key. To decrease the pulse width, press the ( ) key. Figure 5D–Laser Screen Elements Page 28 of 78 850-1065-000, Rev. 6 Cynosure, Inc. - Page 31 To enter the Cynergy MultiPlex screen, exit to the Home Screen and access the MultiPlex screen from there.
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Page 32: Multiplex Treatment Screen
There are eight pulse groups that can be selected in Multiplex mode. Each pulse group has a fixed pulse width for each of the lasers, a range of acceptable fluence parameters, and an appropriate range in which the delay can be set. See, “Cynergy MultiPlex Option,” table on page 37 for specific settings. -
Page 33: Utility Screen
The total number of shots is still recorded in addition to the dye kit count, which equals the shots delivered for that dye kit. See “Dye Kit” under “7–System Status Area,” on page 32 for more information. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 31 of 78... - Page 34 400 to 1200 VDC. 8–Options The options field, when pressed, provides access to the option screen where additional user functions can be performed. Page 32 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
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Page 35: Option Screen
5–Display Dump to USB This field allows users and service personnel to transfer diagnostic information to a USB stick for transfer and further analysis by Cynosure. For more information refer to “Transferring Diagnostic Data,” in the Troubleshooting section starting on page 63. -
Page 36: System Specifications
System Specifications General Specifications Cynergy Specification Pulse Dye Laser (PDL) YAG Laser Type (Flashlamp-excited): Pulse Dye YAG laser Wavelength: 585nm +/- 2% 1064 nm Method of Optical Output: Fused silica optical fiber Cooling Method: Water, internally circulated with heat exchanger to air Protective Safety Eyewear (min): >... -
Page 37: Fluence Specifications
1, 1.5, 2 15.7 1, 1.5 11.8 2-40 1, 1.5, 2 15.8 1, 1.5 11.9 2-40 Pulse Widths: 0.5, 2, 6, 10, 20, 40 ms Yellow = PDL Blue = YAG Cynergy Operator Manual 850-1065-000, Rev. 6 Page 35 of 78... -
Page 38: Cynergy Yag
Cynergy YAG Maximum Minimum Maximum Pulse Starting Fluence Handpiece Rep Rate Rep Rate Fluence Fluence Power Width Fluence Increment (mm) (Hz) (Hz) (J/cm²) (J/cm²) (ms) (J/cm²) (J/cm²) 21.2 5-300 31.8 5-300 42.4 5-300 1, 1.5, 2, 5 24.5 47.1 5-300 70.7... -
Page 39: Cynergy Multiplex Option
Cynergy MultiPlex Option Fixed Pulse Fluence Range Delay Range Width Settings Pulse Group 7-mm 10-mm (ms) (ms) (J/cm²) (J/cm²) 4–8 20–60 Med–Ext Long–Ext 4–8 20–60 Med–Ext Long–Ext 6–12 20–60 Short–Ext Long–Ext 6–12 20–70 Short–Ext Long–Ext 7–12 20–80 Short–Ext Long–Ext 8–15 20–80... - Page 40 This page has been intentionally left blank. Page 38 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
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Page 41: Laser Operation
Make sure that the handpiece is connected and in the cal port. Insert the key into the key switch and turn it to ON. Verify that the front panel display comes on and displays the Cynosure logo. Verify that the system completes its diagnostic routine, and displays the Home screen. -
Page 42: Laser Calibration
Place the handpiece into the Cal Port, and then fire the laser until “FLUENCE VERIFIED” appears on the display. The laser will return to the selected energy output level, and then treatment can continue. Page 40 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 43: Laser Operation
Laser Operation Select the desired fluence, pulse width, wavelength and pulse rate (repetition rate). If using the Cynergy MultiPlex option, select pulse group, fluence and delay. Calibrate the setting. Press the Ready Key to place the laser in Ready Mode. NOTE: In Ready Mode, no laser light is generated until the finger switch or foot switch is depressed. - Page 44 This page has been intentionally left blank. Page 42 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
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Page 45: Clinical Application-Yag
MultiPlex option, see Section 8 starting on page 51. Laser Operator Training Requirements–YAG This manual is not intended to be a complete guide to laser use. Cynosure recommends that all qualified personnel who operate the laser system first seek training that includes, but is not limited to, the following aspects of laser operation: ♦... -
Page 46: Indications, Contraindications And Adverse Effects-Yag
Indications, Contraindications and Adverse Effects–YAG Indications The Cynergy YAG laser is indicated for hair removal, leg and facial veins, vascular lesions, pigmented lesions, and wrinkle reduction. Contraindications Therapy using the Cynergy YAG laser is contraindicated for those patients who: ♦... -
Page 47: Pretreatment Recommendations-Yag
The probable number of treatments needed to achieve the desired outcome ♦ Possible side effects resulting from laser treatment Photographs It is helpful to have photographs of the pretreatment area to assess precisely the success and progression of the treatment. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 45 of 78... -
Page 48: Treatment Recommendations-Yag
Wash the treatment area gently with soap and water. Do not soak. ♦ Do not shave the treated area if crusting is evident. ♦ Avoid contact sports or any other activity that could cause bruising of the treated area. Page 46 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 49: Clinical Application-Pdl
MultiPlex option, see Section 8 starting on page 51. Laser Operator Training Requirements–PDL This manual is not intended to be a complete guide to laser use. Cynosure recommends that all qualified personnel who operate the laser system first seek training that includes, but is not limited to, the following aspects of laser operation: ♦... -
Page 50: Indications, Contraindications And Adverse Effects-Pdl
Indications, Contraindications and Adverse Effects–PDL Indications The Cynergy pulse dye laser is indicated for the treatment of benign cutaneous vascular or vascular dependent lesions. Contraindications Therapy using the Cynergy pulse dye laser is contraindicated for those patients who: ♦ Are hypersensitive to light in the 580–605 nm wavelength region ♦... -
Page 51: Pretreatment Recommendations-Pdl
♦ The gradual clearing of the lesion Photographs It is helpful to have photographs of the pre-treated lesions in order to precisely assess the success and progression of the treatment. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 49 of 78... -
Page 52: Treatment Recommendations-Pdl
Avoid contact sports or any other activity that could cause bruising of the treated area. ♦ Use a sunblock with an SPF of 30+ when treated area is exposed to the sun. ™SmartCool is a trademark of Cynosure, Inc. Page 50 of 78 850-1065-000, Rev. 6... -
Page 53: Clinical Application-Multiplex Option
PDL refer to Section 7 starting on page 47. Laser Operator Training Requirements–MultiPlex This manual is not intended to be a complete guide to laser use. Cynosure recommends that all qualified personnel who operate the laser system first seek training that includes, but is not limited to, the following aspects of laser operation: ♦... -
Page 54: Indications, Contraindications And Adverse Effects-Multiplex
Indications, Contraindications and Adverse Effects–MultiPlex Indications The Cynergy with MultiPlex option is indicated for the treatment of benign cutaneous vascular or vascular dependent lesions. Contraindications Therapy using the Cynergy with MultiPlex option is contraindicated for those patients who: ♦ Are hypersensitive to light in the 580–605 nm or the 1064-nm wavelength region ♦... -
Page 55: Pretreatment Recommendations-Multiplex
♦ The gradual clearing of the lesion Photographs It is helpful to have photographs of the pretreated lesions in order to precisely assess the success and progression of the treatment. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 53 of 78... -
Page 56: Treatment Recommendations-Multiplex
Avoid contact sports or any other activity that could cause bruising of the treated area. ♦ Use a sunblock with an SPF of 30+ when treated area is exposed to the sun. Page 54 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 57: Maintenance
The section also provides a troubleshooting chart with fault codes. Cleaning and Disinfecting Equipment Cynosure suggests that operators periodically clean and disinfect the exterior of the laser system. Always turn off the system before cleaning. The handpiece and tip should be cleaned and disinfected after each treatment session in the following manner: Clean the exterior of the laser system with a mild soap and water. -
Page 58: Dye Kit Methodology
The system will continue to monitor the dye concentration level, but will not require another injection cycle unless the laser is restarted. If the laser is not started for more than a week, it is more likely that additional dye concentrate will be required. Page 56 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 59: Replacing The Dye Kit
Figure 6A. Reverse steps 3-4 to install a new filter. Be sure that the two quick-disconnects are fully seated and “click” in place. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 57 of 78... - Page 60 Reset the PDL count reset button located on the Utility screen, as detailed on page 31. The dye kit count in the system status area of the Utility screen should read zero. Page 58 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
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Page 61: Troubleshooting
2) warnings. Errors faults are critical and will cause the laser to stop operating. These faults codes begin with the prefix ‘E’ meaning error. Some of these errors require that you contact the Cynosure Service Department. Warnings are faults that indicate an improper laser state or operator error. These fault codes begin with the prefix ‘W’... - Page 62 Handpiece handpiece. No Handpiece; Install Handpiece Install handpiece. Handpiece changed. Press screen message box to Handpiece Changed continue. Low Trans; Check Fiber and Fiber, handpiece, or focus lens damaged but still Page 60 of 78 850-1065-000, Rev. 6 Cynosure, Inc.
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Page 63: Self Test
<ABS 0.85 after 30 min cycle (30 injects) Self Test During startup, the laser runs a self test. If the fault occurs during this process, consult the fault code chart above for information on resolving the fault. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 61 of 78... -
Page 64: Troubleshooting Chart
NOTE: If any problems occur that are not covered in the troubleshooting chart, or the suggested solutions do not work, call the Cynosure Service Department, see page 66 for contact information. Page 62 of 78 850-1065-000, Rev. 6... -
Page 65: Transferring Diagnostic Data
USB stick (use only a SanDisk USP flash drive with a minimum of 128 MB storage) and forward that data to Cynosure service personnel for analysis. This data helps service personnel to diagnose the condition of the laser and be prepared should a service call be necessary. To access the USB slot and download data, follow these steps. - Page 66 USB to download results to USB stick. Remove the USB stick from the slot, and then email the data files electronically as directed by Cynosure service personnel. Replace the panel, and then tighten the screw in place by turning it in the opposite direction.
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Page 67: Customer Support
Returned merchandise must be sent insured and prepaid. ♦ The cost of shipping is the responsibility of the customer. ♦ Cynosure has the sole responsibility to determine the cause of merchandise defect. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 65 of 78... -
Page 68: Installation
Installation Cynosure or its authorized personnel installs the laser, gives a demonstration of operation, and provides a basic training service for each new customer. Customer Service Scope of Service Cynosure’s Customer Service Policy includes the following support for customers: ♦... -
Page 69: Appendix A Service Calibration
See, “Laser Calibration,” on page 40 for laser calibration performed by the operator. Schedule for Calibration Cynosure calibrates the laser’s energy meter at the factory prior to shipment. The energy meter should be calibrated once a year by authorized service personnel. Call your local Cynosure representative to arrange for annual calibration by authorized personnel. -
Page 70: Required Equipment
WARNING: Failure to keep the cal port window clean may result in incorrect calibration. ♦ Be sure that the fiber optic is properly routed and secured. ♦ Install a 7-mm handpiece. Page 68 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 71: Calibrating The Resonator Port, Yag
Fire the laser again into the resonator port, and then verify that the resonator energy measures from 43W to 47W. Press lowercase ‘e’ to return the external shutter to normal function. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 69 of 78... -
Page 72: Calibrating The Resonator Port, Pdl
Fire the laser again into the resonator port, and then verify that the resonator energy measures from 7W to 9W. Press lowercase ‘e’ to return the external shutter to normal function. Page 70 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 73: Calibrating The Cal Port, Yag
Press uppercase ‘U’, and then enter the NOVA II power meter reading from step 8. Fire the laser again into the cal port, and then verify that the cal port energy measures from 34W to 36W. Cynergy Operator Manual 850-1065-000, Rev. 6 Page 71 of 78... -
Page 74: Calibrating The Cal Port, Pdl
Press uppercase ‘U’, and then enter the NOVA II power meter reading from step 8. Fire the laser again into the cal port, and then verify that the cal port energy measures from 5.5W to 6.5W. Page 72 of 78 850-1065-000, Rev. 6 Cynosure, Inc. -
Page 75: Appendix B Electromagnetic Compatibility
Appendix B Electromagnetic Compatibility Guidance and Manufacturer’s Declaration—Electromagnetic Emissions The Cynergy is intended for use in the electromagnetic environment specified below. The customer or the user of the Cynergy should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment—Guidance... - Page 76 Guidance and Manufacturer’s Declaration—Electromagnetic Immunity The Cynergy is intended for use in the electromagnetic environment specified below. The customer or the user of the Cynergy should assure that it is used in such an environment. Immunity IEC60601 Compliance Electromagnetic Environment...
- Page 77 If the measured field strength in the location in which the Cynergy is used exceeds the applicable RF compliance level above, the Cynergy should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Cynergy.
- Page 78 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Cynergy The Cynergy is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Cynergy can help prevent electromagnetic interference...
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Page 79: Appendix C Declaration Of Conformity
Directives: EMC Directive 89/336/EEC Medical Device Directive 93/42/EEC Cynosure’s applied quality and design systems have been examined and certified per Registration No. MD19.2613 by the notified body, NSAI. The name, address and phone number of the authorized EU representative is:...
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