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UltraPulse

Carbon Dioxide Laser

Operator Manual

for Encore

and SurgiTouch

Models

Содержание UltraPulse

Страница 1: ...UltraPulse Carbon Dioxide Laser Operator Manual for EncoreTM and SurgiTouchTM Models...

Страница 2: ...als Cipro is a registered trademark of Bayer Corporation Coppertone and Shade are trademarks distributed by Schering Plough HealthCare Products Inc Vaseline is a registered trademark of Chesebrough Po...

Страница 3: ...Instructions 16 Connecting the footswitch 18 Inserting the external door interlock plug 19 Releasing and orienting the articulated arm 20 Connecting the delivery device 22 UltraPulse Delivery Device...

Страница 4: ...rgiTouch Overview 61 Introduction The SurgiTouch User Interface 63 Selecting a Specialty Application and Delivery Device 64 Recalling the last setup 67 Setting Treatment Values 68 Selecting the scan m...

Страница 5: ...nments 112 Calibration Procedure 113 Calibration instructions 114 Warranty Information 115 Decontamination of Returned Equipment 115 Safety and Regulatory Overview 117 Introduction 119 Laser Safety Ey...

Страница 6: ...ons for ENT 157 Safety considerations for LAUP 159 Safety considerations for myringotomy tympanostomy tympanic membrane fenestration 160 Gynecology and GYN Laparoscopy Indications 161 Safety considera...

Страница 7: ...aPulse Laser Systems 9 Laser Preparation 11 UltraPulse Components 12 Connection Instructions 14 UltraPulse Delivery Device Connection Diagram 21 Laser Console Basics 29 Control Screen Basics 35 Preope...

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Страница 9: ...ng aesthetics ENT gynecology neurosurgery and general surgery Our complete line of delivery systems and accessories including the optional UltraPulse SurgiTouch Scanner further extends the versatility...

Страница 10: ...s wavelength is invisible to the human eye therefore a low power visible aiming beam that is coaxial with the invisible treatment beam is used to target tissue Carbon dioxide laser energy is readily a...

Страница 11: ...tems used during surgery including inspecting and cleaning the laser and delivery systems sterilizing connecting and disconnecting the delivery systems and performing laser beam alignment safety check...

Страница 12: ...nner or additional delivery systems if ordered may also be shipped with your laser system UltraPulse Laser Console and Components UltraScan Encore CPG optional Communication cable and clips for UltraS...

Страница 13: ...vices for specific descriptions and operating instructions In addition to the UltraScan Encore CPG and Focused Incisional Handpieces compatible delivery devices include the UltraPulse SurgiTouch Scann...

Страница 14: ...delivery systems as instructed in the appropriate delivery system operator manual WARNING Always disconnect delivery system components from the laser articulated arm before inspection Never look dire...

Страница 15: ...Connection Instructions 15 UltraPulse 0637 129 01 Revision G UltraPulse Connections Scanner communication cable External door interlock Footswitch To electrical outlet...

Страница 16: ...tch Plug the footswitch cable into the footswitch receptacle If the footswitch is not properly connected when the laser is turned on Attach Footswitch displays in the advisory text bar on the control...

Страница 17: ...external interlock receptacle whether or not you are using an external door interlock The laser remains inoperative until the plug is inserted into the receptacle When an external door interlock is i...

Страница 18: ...result in unintended tissue effect When the laser is not in use the articulated arm should be stored in the articulated arm storage compartment with the red protective cap in place Two latches secure...

Страница 19: ...lated arm point toward the ceiling The arrows must point up in order to ensure proper arm orientation An improperly oriented articulated arm can reduce the quality or intensity of the laser beam 4 Rem...

Страница 20: ...s power cable receptacle and the other end to a normal electrical outlet 3 Unpack the air tube with the bacteriological filter and connect one end of the tube to the spigot on the compressor labeled A...

Страница 21: ...nd Puncture Laparoscopic Coupler Variable Spot Laparoscopic Coupler TrueSpot 2 0mm Collimated Handpiece UltraFlex Waveguide Bronchoscope 781 MicroSlad 715 717 718 719 Micromanipulators AcuSpot 712 Mic...

Страница 22: ...end joint Laser articulated arm UltraPulse SurgiTouch Scanner AcuBlade Microsurgery System TM AcuSpot 712 Micromanipulator Blue UltraPulse thread adapter with lens Laser articulated arm UltraPulse Sur...

Страница 23: ...ad adapter without lens Laser articulated arm FiberLase Probe Coupler Lens holder Probe Quick Connector Tube from Purge Air Compressor DeepFX Disposable Tip Blue UltraPulse thread adapter with lens De...

Страница 24: ...y adjusting the weight bar so that it counterbalances the weight of the delivery system To adjust the weight bar 1 Loosen the control knob by rotating it counterclockwise 2 Adjust the weight bar forwa...

Страница 25: ...aScan Encore CPG scanning devices are controlled by laser system software The communication cable provides constant communication between the laser and the scanning device To connect the scanner commu...

Страница 26: ...clips as shown When securing the cable leave enough slack at articulated arm joints to allow free movement and proper positioning of the articulated arm and to avoid damaging the cable 3 Insert the c...

Страница 27: ...ystems with a removable wall plug 1 Ensure that the laser main power circuit breaker is off down and that the laser keyswitch is in the off position 2 Unwrap the power cable from the power cable wrap...

Страница 28: ...UltraPulse 0637 129 01 Revision G 28 General Operation Connecting the main Power Cable Main power cable and plug Power cable wrap Main power circuit breaker...

Страница 29: ...st Touching the screen during system self test may interfere with the system s response to those controls resulting in incorrect power levels Do not depress the footswitch during system turn on or sel...

Страница 30: ...UltraPulse 0637 129 01 Revision G 30 General Operation Controls for Turning On and Restarting the Laser Keyswitch Start On Main power circuit breaker Main power on up...

Страница 31: ...is representative Misalignment of aiming and treatment beams may result in laser exposure to nontarget tissues and possible injury Turning Off the Laser Under normal operating conditions turn the keys...

Страница 32: ...UltraPulse 0637 129 01 Revision G 32 General Operation Controls for Turning Off the Laser Red emergency off button Keyswitch Off Main power circuit breaker Main power off down...

Страница 33: ...adapters and couplers and unplug all cables from the articulated arm and laser console 6 Place the red protective cap securely onto the end of the articulated arm 7 Fold and store the articulated arm...

Страница 34: ...UltraPulse 0637 129 01 Revision G 34 General Operation Moving the Laser Console Footswitch storage mounts Wheel locks...

Страница 35: ...f three treatment control screens SurgiTouch UltraPulse or CW continuous wave You can also select the Options screen from which you can adjust system preferences To select a screen press the appropria...

Страница 36: ...settings You do not need to specify UltraPulse or CW mode The UltraPulse SurgiTouch model includes the application specific SurgiTouch interface The UltraPulse Encore model is fully upgradeable to Su...

Страница 37: ...SurgiTouch Specialty Application and Delivery Device buttons display English and icons simultaneously To change the control screen mode 1 Press the Options tab to view the Options screen 2 Press the...

Страница 38: ...3 W Energy 125 mJ Fluence 9 4 J cm 17 3 J cm 2 2 Pattern 1 Density 5 Size 2 CO Lite 2 TM Active FX TM Active FX GentleTM Max FX TM SurgiTouch UltraPulse CW Options Hz I W J J cm2 1 2 5 I 10 Hz 1 2 5...

Страница 39: ...e safety shutter is closed no treatment beam is available At system startup the laser automatically goes into standby mode When you select ready mode the system emits a low pitched tone to indicate th...

Страница 40: ...W 125 mJ 9 4 J cm2 0 10 s 1 2 5 17 3 J cm2 J J cm2 I I 1 2 5 SurgiTouch UltraPulse CW Options CO Lite 2 TM Active FX TM Active FX GentleTM Max FX TM Standby Ready Laser emission Advisory message Laser...

Страница 41: ...button 1 When the button displays press it to view additional messages 2 Press the button to acknowledge that you have read and understood the advisory message and are ready to proceed Advisory Messa...

Страница 42: ...the and buttons on the language selector to scroll through the available languages The selected language appears in the language display Selecting the Advisory Text Language Danish Greek Dutch Italia...

Страница 43: ...s the aiming beam may obstruct the view of the treatment site while lasing The aiming beam can be either on or off while lasing To turn on the aiming beam press the on button on the aiming beam on off...

Страница 44: ...is off the aiming beam is continuous To set the aiming beam to blink press the on button on the blink control To set the aiming beam to continuous press the off button on the blink control Selecting...

Страница 45: ...beam intensity press the and buttons on the aiming beam intensity control Adjusting the Aiming Beam Intensity English The error text will be displayed in English Beam Offset SurgiTouch UltraPulse CW E...

Страница 46: ...ne when a minimum or maximum setting is reached or when an error has occurred 1 Press the Option tab to view the Options screen 2 Press the and buttons on the volume control Adjusting the System Volum...

Страница 47: ...e Exposure ON OFF You can select an exposure tone during treatment If the exposure tone is on an audible tone is heard during treatment If the exposure tone is off no tone is heard during treatment 1...

Страница 48: ...use When configured to Off the system will switch to Standby after two hours 1 To configure Sleep Mode to On press the on button on the Options screen 2 To configure Sleep Mode to Off press the off b...

Страница 49: ...een 2 Disconnect the communication cable from the scanning accessory and disconnect the accessory from the articulated arm 3 Connect the desired scanning accessory to the articulated arm and connect t...

Страница 50: ...ry locations for each delivery device within an application and specialty To save treatment settings 1 On the appropriate treatment screen set the treatment values that you would like to save 2 Press...

Страница 51: ...0 W 0 00 s 10 ms ENT Larynx AcuBlade 400mm 1 2 0 mm 2 I I W SurgTouch UltraPulse CW Options Open memory window W 10 W 30 W 0 00 s 10 mS 1 2 0 mm 2 ENT Larynx AcuBlade 400mm I I 1 3 2 Open Save SurgiT...

Страница 52: ...numbered buttons represent the memory locations for the active treatment screen In SurgiTouch the memory locations apply to the selected delivery device within an application and specialty 3 Press the...

Страница 53: ...e 0637 129 01 Revision G Retrieving Treatment Settings W 10 W 30 W 0 00 s 10 ms 1 2 0 mm 2 ENT Larynx AcuBlade 400mm I I 1 3 2 Open Save SurgiTouch UltraPulse CW Options Memory locations Retrieve trea...

Страница 54: ...treatments PigmentFX mode is available only when the CPG is connected to the UltraPulse laser CO2 Lite Button The CO2 Lite button displays on the UltraPulse treatment screen when the UltraScan Encore...

Страница 55: ...uttons to adjust the vertical position of the beam press the and buttons to adjust the horizontal position of the beam Press the reset button to re center the beam WARNING Laser beam alignment checks...

Страница 56: ...l Purge Air Compressor as instructed in Connection Instructions in this manual 7 Turn on the laser as instructed in Laser Console Basics in this manual 8 Perform the beam alignment check as instructed...

Страница 57: ...eepFX microscanner preview the pattern as described in the UltraScan Encore CPG operator manual CAUTION Before beginning a procedure with the UltraScan Encore CPG or the SurgiTouch scanner or the Deep...

Страница 58: ...r Compressor Disconnect its air tube from the delivery device 6 Disconnect the delivery system including all adapters and couplers Clean the delivery system and store in the appropriate storage contai...

Страница 59: ...37 129 01 Revision G 59 SurgiTouch Enabling application specific settings Overview Introduction The SurgiTouch User Interface 61 Selecting a Specialty Application and Delivery Device 62 Setting Treatm...

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Страница 61: ...iseFX TrueSpot 2 0mm Collimated Handpiece ENT Otolaryngology Tonsil Multi Application Oral Pharyngeal Nasal Delivery System Uvula Multi Application Oral Pharyngeal Nasal Delivery System Bronchi 781 La...

Страница 62: ...For complete operating instructions of these modules refer to the UltraScan CPG operator s manual or the DeepFX operator s manual From this point forward the operating instructions narrative will dis...

Страница 63: ...t settings for the AcuBlade at a 400 mm working distance as shown SurgiTouch Treatment Screen Showing Default Delivery Device and Treatment Settings for ENT Larynx 4 A message appears in the advisory...

Страница 64: ...ication or delivery device SurgiTouch Selecting a New Specialty Application or Delivery Device Delivery Device Screen Shown ENT Larynx AcuBlade 400mm 1 0 7 mm 1 I I SurgiTouch UltraPulse CW Options Se...

Страница 65: ...the SurgiTouch control screen The SurgiTouch treatment screen automatically displays the default treatment settings for the last setup Verify that the correct delivery device is attached then press th...

Страница 66: ...electing the Scan Mode Non Scan or Scan The laser supplies a default scan mode Non scan or Scan The default mode depends on the selected operating parameters For some delivery devices only Non scan mo...

Страница 67: ...nt Values 67 UltraPulse 0637 129 01 Revision G SurgiTouch Selecting the Scan Mode 10 0 W 0 00 s 10 ms ENT Larynx AcuBlade 400mm 1 2 0 mm 2 I I W SurgiTouch UltraPulse CW Options Select Scan mode Selec...

Страница 68: ...amage can occur as a result of incorrect power settings Use the lowest acceptable settings until you understand the biological interaction between the laser power and tissue CAUTION The power shown on...

Страница 69: ...from the default setting the default power appears below the selected setting in the power display as shown indicating that the power is set outside of recommended parameters W 16 0 W 30 W 1 00 s 146...

Страница 70: ...atment screen Scanner settings including shape size and depth are active when Scan mode is selected Setting the Scan Shape Press the and buttons on the scan shape selector to scroll through the availa...

Страница 71: ...s the and buttons on the scan size selector The selected scan size displays on the control screen SurgiTouch Setting the Scan Size W 10 W 30 W 0 00 s 10 ms 1 2 0 mm 2 ENT Larynx AcuBlade 400mm I I Sur...

Страница 72: ...pth selector The selected depth displays on the control screen The scan depth represents the number of times that the selected pattern is scanned SurgiTouch Setting the Scan Depth W 10 W 30 W 0 00 s 1...

Страница 73: ...timed exposure on in Non scan mode treatment energy is delivered only for a specified duration after which treatment stops Treatment also stops if the footswitch is released before the specified durat...

Страница 74: ...posure time in mil liseconds displays on the control screen 2 Set the exposure time by pressing the and buttons on the timed expo sure bar 3 To turn off timed exposure press the timed exposure off but...

Страница 75: ...s active The delay time in seconds displays on the control screen Available intervals are 0 5 0 seconds 3 Set the repeat delay interval by pressing the and buttons on the repeat delay bar 4 To change...

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Страница 77: ...1 Revision G 77 UltraPulse Overview Setting the Energy or Fluence 79 Setting the Repetition Rate or Average Power 82 Timed Exposure and Repeat Delay in UltraPulse Mode 84 Setting Timed Exposure 85 Set...

Страница 78: ......

Страница 79: ...shown on the energy display indicates the energy delivered to the end of the articulated arm not necessarily the amount delivered to the treatment site Consult your delivery system operator manual to...

Страница 80: ...changes in spot size The table should not be used to set treatment parameters but simply as a guide to fluence and its relationship with laser energy and spot size Serious tissue damage can occur as a...

Страница 81: ...1 8 1 27 0 75 0 32 0 25 0 20 0 14 0 10 0 08 0 05 0 04 25 79 6 3 18 1 88 0 80 0 63 0 51 0 35 0 26 0 20 0 13 0 09 30 95 54 3 82 2 26 0 96 0 75 0 61 0 42 0 31 0 24 0 15 0 11 40 127 39 5 10 3 02 1 27 1 01...

Страница 82: ...will emit a low tone indicating that the value is not available To achieve the higher rate or power you will need to lower the energy setting Note as discussed in Energy level and fluence in this cha...

Страница 83: ...ing the Repetition Rate or Average Power Hz 10 Hz W 1 3 W 10 Hz 1 3 W 100 mJ 7 5 J cm2 10 ms J J cm2 Hz W I 0 10 s I UltraPulse CW SurgiTouch Options CO Lite 2 TM Active FX TM Active FX GentleTM Max F...

Страница 84: ...g the footswitch treatment duration is continuous until the footswitch is released With timed exposure on treatment energy is delivered only for a specified duration after which treatment stops Treatm...

Страница 85: ...nd buttons on the timed expo sure bar In UltraPulse mode exposure time increments are dependent upon the rate setting the higher the rate the smaller the increments and hence the more control you have...

Страница 86: ...eat delay intervals are 0 1 5 0 seconds 3 Set the delay time by pressing the and buttons on the repeat delay bar 4 To change from repeat delay to single timed exposure press the repeat delay off butto...

Страница 87: ...UltraPulse 0637 129 01 Revision G 87 CW Overview Setting the Power 89 Timed Exposure and Repeat Delay in CW Mode 91 Setting Timed Exposure 92 Setting Repeat Delay 93...

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Страница 89: ...e Power Press the and buttons on the power bar CAUTION The power shown on the power display indicates the power delivered to the end of the articulated arm not necessarily the amount delivered to the...

Страница 90: ...e the lowest acceptable settings until you understand the biological interaction between the laser power and tissue CAUTION As indicated in the table power density is inversely related to spot size fo...

Страница 91: ...on treatment power is delivered only for a specified duration after which treatment stops Treatment also stops if the footswitch is released before the specified duration is complete To deliver addit...

Страница 92: ...nds displays on the control screen 2 Set the exposure time by pressing the and buttons on the timed exposure bar In CW mode exposure time is available in 1 millisecond increments 3 To turn off timed e...

Страница 93: ...in seconds displays on the control screen Available repeat delay intervals are 0 1 5 0 seconds 3 Set the delay time by pressing the and buttons on the repeat delay bar 4 To change from repeat delay t...

Страница 94: ......

Страница 95: ...enance Overview Troubleshooting Guide 97 User Maintenance 104 Electrical Utilities 105 Specifications 107 External Door Interlock Pin Assignments 110 Calibration Procedure 111 Warranty Information 113...

Страница 96: ......

Страница 97: ...that the external door interlock plug is inserted in the external door interlock receptacle Close the interlocked door Articulated Arm Verify that the articulated arm is properly positioned Problem Pr...

Страница 98: ...ion the articulated arm See Releasing and orienting the articulated arm in the General Operation section of this manual The articulated arm or laser system is internally misaligned Contact your local...

Страница 99: ...otswitch cable is not properly connected to the laser console or the footswitch cable is defective Ensure that the footswitch is properly connected to the laser console and that the footswitch cable i...

Страница 100: ...on to acknowledge the message then select a non CPG application UltraScan Encore CPG is attached advisory message appears You have inadvertently selected a non CPG application or mode To continue oper...

Страница 101: ...the UltraPulse SurgiTouch Scanner select a scanning application and delivery device You have attached the UltraPulse SurgiTouch Scanner while in CW or UltraPulse mode To operate with the UltraPulse Su...

Страница 102: ...to acknowledge the message Coolant Too Hot advisory message appears The coolant in the laser is overheating Verify that nothing is blocking the front or rear vents on the laser Verify that there is ad...

Страница 103: ...service department Microscanner is Overheating The CPG s body feels warmer than normal to your touch Shut down the laser system disconnect the microscanner and refer to Lumenis service department Micr...

Страница 104: ...ernal Surfaces of the Laser Console Use a cloth dampened with a noncaustic cleaning solution such as soap and water isopropyl alcohol or a hospital grade disinfectant to wipe the external surfaces of...

Страница 105: ...he 200 208 VAC configuration must be supplied from a dedicated 200 208 or 230 10 VAC single phase 50 60 Hertz source The wiring should be rated for 16 amps as per local codes Hospital Grade NEMA L6 30...

Страница 106: ...s engineer or electrical contractor will be responsible for ensuring that the proper electrical requirements are available at the site Systems Designed for Use Outside of Europe In most instances cus...

Страница 107: ...ication Class IV European MDD Laser Classification Class 4 UltraPulse mode Energy per pulse 1 mJ increments 2 10 mJ 5 mJ increments 10 30 mJ 10 mJ increments 30 100 mJ 25 mJ increments 100 225 mJ Repe...

Страница 108: ...60 Hz Single phase 15 A Environmental requirements Maximum altitude 3048 meters 10 000 feet Operating temperature 10 C to 25 C 50 F to 77 F Maximum humidity 90 Relative Physical characteristics Office...

Страница 109: ...is intended for use only with Lumenis qualified delivery systems Refer to the UltraPulse Delivery Device Connection Diagram in the General Operation section of this manual for a list of compatible de...

Страница 110: ...ser is in ready mode The interlock can be set up with a remote switch or an external switch can be wired to the interlock plug Plug wiring shall only be performed by a qualified electrical professiona...

Страница 111: ...ng Calibration is a service procedure to be done only by Lumenis certified Service Engineers or customers who have taken and passed a Lumenis Service Certification Training course Adjustment by anyone...

Страница 112: ...9 Record the power meter reading and release the footswitch If the power meter reading falls above or below 20 of maximum power for your laser discon tinue this procedure and contact your local Lumen...

Страница 113: ...w equipment shipped to Lumenis US offices for repair or return must be properly decontaminated with a chemical germicide that is commercially available and cleared for use as a Hospital Disinfectant T...

Страница 114: ......

Страница 115: ...raPulse 0637 129 01 Revision G 115 Safety and Regulatory Overview Introduction 117 Laser Safety Eyewear 118 Additional Ocular Protection 121 Additional Safety Considerations 122 Regulatory Compliance...

Страница 116: ......

Страница 117: ...r beams except as a therapeutic application Additional precautions must be taken to prevent fire electrical injury and explosion Lumenis does not make recommendations regarding the practice of medicin...

Страница 118: ...g formula was used to calculate the worst case NOHD for Lumenis UltraPulse lasers and compatible delivery systems where Z the distance of the beam waist from the laser system a the beam waist diameter...

Страница 119: ...are considered to be within the controlled area and shall wear eye protection with a minimum optical density OD of Z a NOHD 1 4 MPE Pf a2 Z Laser system Laser System MPE Pf a Z UltraPulse Encore and...

Страница 120: ...ar take the following steps to secure the treatment room or the controlled area 1 To alert personnel before they enter the controlled area place a warning sign on the outside of the treatment room doo...

Страница 121: ...m direct or indirect exposure to the treatment beam The predominant ocular structures at risk are dependent on the laser wavelength in use In general visible and near infrared wavelengths are most dam...

Страница 122: ...ower densities avoid prolonged exposure to limit depth of incision CAUTION Plastic instruments such as speculums or eye shields can melt when impacted by the laser beam possibly resulting in chemical...

Страница 123: ...tances An explosion or fire could occur WARNING The area around the target site can be protected with wet towels or gauze sponges If allowed to dry these protective towels and sponges can increase the...

Страница 124: ...be combustion Use endotracheal tubes that are least hazardous to the patient Laser resistant cuffed and flexible stainless steel endotracheal tubes are commercially available Red rubber or silicone en...

Страница 125: ...tubing or probe used to evacuate the laser plume should not be used to suction blood or fluids unless it is specifically designed and set up to perform both functions simultaneously Instruments with...

Страница 126: ...er energy transmission Cleaning the device optics or adjusting the laser articulated arm may eliminate this problem however this may also effectively increase the laser energy delivered to the treatme...

Страница 127: ...beam Saline may be used in the abdomen to absorb stray laser energy Specialized instrumentation such as laparoscopes with laser beam backstops and retractors designed to protect nontarget tissues may...

Страница 128: ...dards Residual Current Circuit Breaker Lumenis strongly recommends the installation of a residual current circuit breaker RCCB also referred to as a ground fault circuit interrupter GFCI This is an el...

Страница 129: ...the keyswitch is turned to the start position the laser power up sequence is initiated Location of Controls Operation and adjustment controls are located so that the user need not be exposed to laser...

Страница 130: ...perator Refer to the Troubleshooting Guide in this manual for additional information Safety Shutter The laser includes an electronic safety shutter that prevents unintentional laser emission The safet...

Страница 131: ...n G Location of Regulatory and System Labels As required by national and international regulatory agencies appropriate warning labels have been mounted in specified locations Location of Regulatory Co...

Страница 132: ...UltraPulse 0637 129 01 Revision G 132 Safety and Regulatory Location of Regulatory Compliance Labels Laser Aperture Laser aperture label...

Страница 133: ...IATION CLASS 4 LASER PRODUCT per IEC 60825 1 2001 CLASS IV LASER PRODUCT per 21 CFR 1040 LASER CLASS 4 IV CO2 10 600 nm 225 mJ 2 ms pulse Max 60W Max LASER CLASS 3A IIIa Diode Laser 635 nm 5 mW Max CW...

Страница 134: ...HAPTER J 200 240V 50 60 Hz 16A 1 100 120V 50 60 Hz 20A 1 CAUTION U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Attention read manual US FDA Prescription use device st...

Страница 135: ...ic shock protection Electrical shock hazard warning Emergency stop Danger Possible explosion hazard if used in the presence of flammable anesthetics oxygen or nitrous oxide Class I equipment Mains swi...

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Страница 137: ...Indications 142 Podiatry Indications 152 Otolaryngology ENT Indications 153 Gynecology and GYN Laparoscopy Indications 159 Neurosurgery Indications 161 Orthopedics Indications 162 General and Thoraci...

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Страница 139: ...n this chapter Read and comprehend all of the following general contraindications warnings precautions and recommendations as well as indications and safety considerations for appropriate specialties...

Страница 140: ...recluded by anesthesia requirements site access or other general operative considerations General Laser Warnings and Precautions WARNING There is a risk of infection and scarring associated with any s...

Страница 141: ...d literature and attending procedure specific training programs See the UltraPulse Delivery Device Connection Diagram in the General Operation section of this manual for a list of compatible delivery...

Страница 142: ...collagen Laser skin resurfacing ablation and or vaporization of soft tissue for the reduction removal and or treatment of keratoses including actinic and seborrheic keratosis seborrhoecae vulgares seb...

Страница 143: ...sion and or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty Laser incision and or excision of soft tissue for the creation of recipient sites for hair transplantat...

Страница 144: ...al skin lesions may be contraindicated in patients unwilling to accept the potential risk of scar formation Complications and Expected Sequelae General dermatology and plastic surgery complications in...

Страница 145: ...as compared to cold steel reduced intraoperative and or postoperative pain as compared to cold steel slightly reduced healing time as compared to cold steel conjunctivitis usually transient ptosis usu...

Страница 146: ...ing Precautions and Recommendations CAUTION Lower energy densities may cause excessive thermal injury to underlying tissue through conducted heat High energy densities may result in excessive tissue v...

Страница 147: ...through 2 weeks postoperatively itching that generally resolves within the first 2 weeks postoperatively textural change that is generally observed between 2 and 12 weeks postoperatively and resolves...

Страница 148: ...is TN USA and Retin A Ortho Pharmaceutical Corporation Dermatological Division Raritan NJ USA should be applied topically once daily in the morning for a minimum of 2 weeks Subjects with an increased...

Страница 149: ...requent outbreaks of facial HSV clinicians recommend antiviral agents such as Valtrex Galxo Wellcome Inc Research Triangle Park NC USA or Famvir SmithKline Beecham Pharmaceuticals Philadelphia PA USA...

Страница 150: ...mode CO2 Lite is used to perform light skin resurfacing CO2 Lite mode can be used to limit depth of tissue injury A single pass is recommended when operating in CO2 Lite mode and fluence is limited to...

Страница 151: ...usting of the serous exudate is diminished usually between 7 and 14 days postoperatively Subjects should apply cool water and white vinegar soaks to the treated area at least 4 times daily making sure...

Страница 152: ...ts including paronychial periungal and subungual warts fungal nail treatment porokeratoma ablation ingrown nail treatment neuromas fibromas including Morton s neuroma debridement of ulcers other soft...

Страница 153: ...um endoscopic laser assisted esophagodiverticulostomy ELAED stenosis including subglottic stenosis tonsillectomy including tonsilar cryptolysis and neoplasma and tonsil ablation tonsillotomy pulmonary...

Страница 154: ...UltraPulse 0637 129 01 Revision G 154 Indications for Use partial glossectomy tumor resection of oral subfacial and neck tissues rhinophyma verrucae vulgares warts gingivoplasty gingivectomy...

Страница 155: ...he patient consideration of the type of anesthesia and ventilation are important WARNING To prevent severe injury to the patient middle ear surgery should be performed with appropriate parameters cons...

Страница 156: ...aPulse 0637 129 01 Revision G 156 Indications for Use Cordotomy formation of granuloma Turbinate Reduction Ablation transient nasal obstruction associated with postoperative edema and limited nasal cr...

Страница 157: ...ars because the upper airway is not fully developed When used as the only form of treatment for palatal snoring LAUP may not be effective in obese patients patients with severe tonsillar hyperplasia o...

Страница 158: ...e pediatric patients should be appropriately restrained during office OtoLAM myringotomy tympanostomy procedures It is recommended that a local or topical anesthesia be administered prior to the OtoLA...

Страница 159: ...tal vulvar perineal and Bowenoid papulosa BP lesions leukoplakia vulvar dystrophies incision and drainage I D of Bartholin s and nabothian cysts herpes vaporization urethral caruncle vaporization cerv...

Страница 160: ...s emphysema Precautions for Laparoscopic Surgery CAUTION When using a laser laparoscope or waveguide accessory maintain an adequate flow of CO2 purge gas through the delivery device High purge flows r...

Страница 161: ...d large tumors arteriovenous malformation pituitary gland tumors transphenoidal approach Safety Considerations for Neurosurgery Contraindications Do not use the laser on tumors that are inoperable or...

Страница 162: ...int revision PMMA removal Safety Considerations for Orthopedics Warnings and Precautions WARNING When performing arthroscopic surgery with waveguides where purge gas is required control the purge gas...

Страница 163: ...rotomy and laparoscopic applications mediastinal and thoracic lesions and abnormalities skin tag vaporization atheroma cysts including sebaceous cysts pilar cysts and mucous cysts of the lips pilonida...

Страница 164: ...onal and excisional biopsy treatment of ulcerous lesions including aphthous ulcers incision of infection when used with antibiotic therapy frenectomy frenum release excision and ablation of benign and...

Страница 165: ...ted for hard tissue applications Precautions CAUTION While directing the laser beam near the tooth shield the tooth from laser energy using either nonreflecting metal or an instrument inserted between...

Страница 166: ...nclude benign and malignant lesions of external genitalia condyloma phimosis erythroplasia Safety Considerations for Genitourinary Procedures Complications There are no known complications specific to...

Страница 167: ...ty Dermatol Surg 1995 21 1060 1063 8 Unger W Laser Hair Transplantation II Dermatol Surg 1995 21 759 765 9 Fitzpatrick R Laser Hair Transplantation Tissue Effects of Laser Parameters Dermatol Surg 199...

Страница 168: ...atome Journal of the American Academy of Dermatology 2000 42 1 92 105 19 Fitzpatrick R E Tope W D Goldman M P et al Pulsed Carbon Dioxide Laser Trichloroacetic Acid Baker Gordon Phenol and Dermabrasio...

Страница 169: ...untry has undergone decontamination with a commercially available germicide cleared for use as a Hospital Disinfectant and is clean and free from biohazards including but not limited to human or anima...

Страница 170: ......

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