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Fraxel

®

1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System

Part Number 10-05170 Rev. O

Page 46 of 92

3.0 Safety

The following Fraxel systems are each classified as Class 4 lasers according to Center for
Devices and Radiological Health (CDRH) and IEC / EN regulations: Fraxel 1550, Fraxel
1927 and the Fraxel DUAL 1550/1927 Lasers. This classification represents the highest
power laser. Users and staff must take precautions to prevent exposure of laser energy to
the eye and/or skin from either direct or diffusely reflected laser beams. In addition,
precautions must be taken in the surgical environment to prevent hazards of fire and
electrical injury.

This section discusses the primary safety concerns when operating the both Fraxel 1550,
Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems. The instructions are intended to
raise awareness of the safety issues and provide insight so that hazardous optical,
mechanical, electrical, and chemical risks may be minimized.

CAUTION: Prior to use of the Fraxel Laser Systems, this manual must be thoroughly
read and understood by the personnel involved with operating the System. Improper
use may cause personal injury and damage to the System and may invalidate any
warranty agreement.

CAUTION: Improper service, repair or modifications performed by unauthorized
personnel may pose a hazard and will invalidate any warranty agreement.

CAUTION: United States Federal law restricts this device to sale by or on the order of
a physician.

CAUTION: The availability of electronic alarms does not relieve operators of their
obligation to carefully monitor the entire system during operation. CAUTION: Laser
plumes may contain viable tissue particles.

Although the Solta system is a contact non-ablative system which normally cannot
produce any smoke or plume, any laser plume (debris) generated by the laser is
potentially hazardous. It may obscure the laser operating field and may contain
viable airborne pathogens. Any plume generated as part of a laser procedure must
be evacuated promptly and effectively. If such plumes are observed during normal
operation of the laser as instructed by this manual and as directed in the Solta
training, immediately stop treating, shut off the laser system and contact Solta
Customer Service

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Содержание Fraxel 1550

Страница 1: ...axel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser Systems Operator Manual Fractional Resurfacing with IOTS Intelligent Optical Tracking System Manufactured by Solta Medical Inc 25881 Industrial Bl...

Страница 2: ...cal Tracking are trademarks or registered trademarks of Solta Medical Inc and its subsidiaries Other names and brands may be claimed as the property of others Various aspects of the Fraxel 1550 Fraxel...

Страница 3: ...tore FRAXEL 1927 AND FRAXEL DUAL 1550 1927 previously known as the Fraxel re store DUAL LASER SYSTEMS ARE ALL NON ABLATIVE LASERS AND INTENDED FOR USE ONLY BY PROPERLY TRAINED PHYSICIANS AND PROPERLY...

Страница 4: ...Y 46 3 1 GENERAL CONSIDERATIONS AND HAZARD POTENTIAL 47 3 2 FIRE PRECAUTIONS 47 3 3 OPTICAL SAFETY 49 3 4 OPERATION OF THE LASER SYSTEM 53 3 5 ELECTRICAL SAFETY 55 3 6 LASER TREATMENT CONTROLLED AREA...

Страница 5: ...ATORY CLASSIFICATIONS 79 8 1 GENERAL STANDARDS 79 9 0 FRAXEL LASER SYSTEMS SPECIFICATIONS 80 9 1 TREATMENT BEAM 80 9 2 CONSOLE 80 9 3 LASER SAFETY EYEWEAR 81 9 4 CART 81 9 5 OPERATING ENVIRONMENT 81 9...

Страница 6: ...he following illustrates each of these messages and how to recognize them Warning Message The Warning Message alerts the operator about safety and non compliance issues that are of the highest importa...

Страница 7: ...nd safety precautions provided in this manual This manual covers the following part numbers Part MC SYS SR1500 D US MC SYS SR1500 D UPG US MC SYS SR1500 P US MC SYS SR1500 P UPG US MC SYS SR1500 CPO U...

Страница 8: ...indicated for use in dermatological procedures requiring the coagulation of soft tissue treatment of actinic keratosis and treatment of pigmented lesions such as but not limited to lentigos age spots...

Страница 9: ...ttern These advanced features allow for precisely controlled delivery of the fractional laser treatment Interchangeable tips allow for treatment of both small and large areas The small tip design is i...

Страница 10: ...Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 10 of 92 Front Console with Zimmer Cart Umbilical Cord and Support Arm Key Switch Emergency switch...

Страница 11: ...Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 11 of 92 Rear Console with Cart Power Connection Footswitch Connection Remote Door Interlock Locking Casters Product Labeling and Ide...

Страница 12: ...Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 12 of 92 Treatment Handpiece with Cool Roller Tip installed Focal cooling not available on all models...

Страница 13: ...ton during an emergency to stop the laser treatment beam To restart twist the button and release it from the latched OFF position 1 4 4 Calibration Port The calibration procedure is enforced by the so...

Страница 14: ...ed onto the handpiece The rollers used in the Fraxel Cool Roller Tip are for single patient use only Do not reuse Multiple patient use may create the potential risk of cross contamination of biologica...

Страница 15: ...this directive may result in serious injury or damage to the unit 1 5 System States The system has defined states of operation which include utilities home system test simulate and treat 1 5 1 Utilit...

Страница 16: ...se of fire retardant curtains water soaked towels or gauze where necessary See Section 3 0 for more details 2 2 4 Check the power cord for damage Ensure that the appropriate electrical utilities are a...

Страница 17: ...it is necessary to manually lift the Laser System console and cart or to separate the console from the cart two people must perform the lifting operation Failure to follow this directive may result i...

Страница 18: ...ystem will briefly display an introductory splash screen 2 3 1 System Test Mode Upon completion of the system power up the system will enter the System Test mode Please follow the instructions as they...

Страница 19: ...rt to make sure it is correctly placed and try again to a maximum of 3 times After three attempts contact Solta Medical Customer Service If the system fails to calibrate to within 80 of the requested...

Страница 20: ...20 of 92 2 3 2 Utilities Home Upon successful completion of the System Test the touch screen display will immediately transition to the Utilities Home Mode The Utilities Home Mode allows various syst...

Страница 21: ...Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 21 of 92 Fraxel 1550 Home screen...

Страница 22: ...set in the Utilities Home Mode Treatment Wavelength Treatment Wavelength Controls allow either the 1550 nm or the 1927 nm laser to be selected on the Fraxel DUAL 1550 1927 Laser System model From the...

Страница 23: ...g the training phase for new operators of the Fraxel Laser Systems and should be utilized fully before the first patient treatment is performed The Operator can also select Simulate Mode in order to f...

Страница 24: ...Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 24 of 92...

Страница 25: ...o inadvertent laser exposure When the final selection of utilities has been performed and treatment simulations have been completed the Operator may select to transition into Treat Mode If Treat is se...

Страница 26: ...f 92 Once the tip is detected by the system the touch screen display will indicate that initialization is occurring but will remain in standby mode After initialization the Operator may adjust the tre...

Страница 27: ...xel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 27 of 92 In order to initiate treatment the Operator must depress the footswitch and initiate handpiece moti...

Страница 28: ...5170 Rev O Page 28 of 92 Active treatment and laser emission will only occur when the footswitch is depressed and the IOTS senses motion across the skin s surface When the system is actively treating...

Страница 29: ...1550 1927 Laser System Part Number 10 05170 Rev O Page 29 of 92 In order to change treatment parameters or interrupt treatment the Operator must select Standby The touch screen display will then indi...

Страница 30: ...The Pulse Energy Level Indicator field should be used to increase or decrease pulse energy The Treatment Level Indicator field should be used to increase or decrease level of treatment This is a func...

Страница 31: ...ber 10 05170 Rev O Page 31 of 92 The Handpiece Velocity Indicator displays handpiece velocity in cm s White zone indicates normal operation Black zone indicates under treatment Tip information display...

Страница 32: ...patient every time the Fraxel Laser Systems are used Remember the following steps Use eye protection Use settings listed on pattern prep paper o 1550nm 20mJ 40mJ TL7 8 passes o 1927nm 10mJ 20mJ TL7 8...

Страница 33: ...er surface area measurements are completed the system will calculate the Estimated kJ reading based on desired treatment level and measured surface area This value should be used as a point of referen...

Страница 34: ...the measurement touch screen display After completion of the measurements for a particular treatment area the Operator may select an additional treatment region for measurement In order to do so the O...

Страница 35: ...easurement should be completed by administering a pass that begins at the lateral hairline and extends along the vertical axis to the jawline The vertical measurement should pass directly through the...

Страница 36: ...tending from the base of the nose to the center of the lips and complete a horizontal pass until the lateral edge of the jawline level with respect to the base of the earlobe If the width measurement...

Страница 37: ...O Page 37 of 92 After completion of all necessary measurements the touch screen display will list the Estimated kJ value and the treatment area measurement cm2 If the surface area needs to be recalcul...

Страница 38: ...ulations Estimated kJ values are intended only to guide the assessment of energy delivered during treatment not to replace physician assessment of treatment adequacy or assessment of clinical outcome...

Страница 39: ...the pattern shown below although the spot pitch and stride may not be identical MEND A MEND is a Micro Epidermal Necrotic Debris particle This is a compact accretion of necrotic epidermal debris whic...

Страница 40: ...eters 2 8 System Audible Feedback The laser system console will generate audible tones during normal operation which vary as a function of handpiece velocity This indicates that the tracking system is...

Страница 41: ...this hand motion and listen to the tones generated by the machine without firing the laser NOTE In order for the IOTS to stay locked during a treatment it is important that the tip stay in good physi...

Страница 42: ...ting treatment of a small tissue area selection of the smaller tip may be more appropriate As the treatment area increases use of the larger tip may be more efficient and may require fewer treatment p...

Страница 43: ...e Multiple patient use may create the potential risk of cross contamination of biological agents from one patient to another CAUTION Tip cleaning and care protocols are critical to optimizing tip life...

Страница 44: ...s in the prepared detergent During cleaning or disinfection DO NOT allow any liquid to come into contact with the chip inside the tip Rinse the part of the tip exposed to either IPA or enzymatic deter...

Страница 45: ...on preventing infection from reusable medical equipment can be found at http www biomedcentral com 1471 2334 2 4 2 11 Normal Shut down Procedure 2 11 1 Secure the handpiece safely in the recess in th...

Страница 46: ...must be thoroughly read and understood by the personnel involved with operating the System Improper use may cause personal injury and damage to the System and may invalidate any warranty agreement CA...

Страница 47: ...nd or fire could occur and severe injury could result Warning Take extra precautions when using this laser around an airway endotracheal oxygen tube Firing the laser into the airway oxygen tube could...

Страница 48: ...ich could cause serious injury 3 2 6 Do not attempt to operate the laser without a non flammable backstop downrange from the handpiece Without the nonflammable backstop inadvertent exposure of the las...

Страница 49: ...operators shall attend the appropriate laser training course and shall receive certification and or credentialing prior to patient treatment 3 3 6 Laser safety eyewear is routinely required with most...

Страница 50: ...protected during treatment Failure to use appropriate eyewear with the Fraxel Laser Systems increases the risk of injury to the cornea sclera and soft tissue of the eye 3 3 10 Extra precautions must b...

Страница 51: ...protective eyewear are provided with each Fraxel Laser System Additional sets may be purchased from Solta See Section 6 0 Re Order Information One set of the eyewear is designed to be used over optica...

Страница 52: ...hensive understanding of the risks involved and knowledge of the safety precautions required for these lasers to ensure the safety of the patients and others within the NOHD Warning Never look directl...

Страница 53: ...clinical practice The following guidelines are suggested as a starting point from which operators may become familiar with good clinical laser technique through study of the medical literature The gu...

Страница 54: ...ot move the footswitch while the laser is in Treat mode other than to initiate a treatment Do not move the footswitch by placing a foot in the housing and lifting it up Do not pull the footswitch by i...

Страница 55: ...ould be taken when plugging the unit into the wall outlet The area must be free of water and your hands must be dry to avoid electric shock Always disconnect the laser by grasping and pulling the plug...

Страница 56: ...flammable window filter specific for the wavelength being used in order to prevent inadvertent escape of laser light Note that a material that appears opaque to the eye may not be opaque at the treatm...

Страница 57: ...dry before initiating another treatment in order to mitigate the risk of fire or serious injury could result 3 8 3 Make sure that the handpiece umbilical cable is not excessively twisted from the uni...

Страница 58: ...laser system with a soft cloth dampened with mild soap and water Warning Inspect the handpiece umbilical armoring for damage on a routine basis Do not use the device if the umbilical is damaged as ina...

Страница 59: ...use set the system and treatment parameters prior to treatment simulate treatment manage tip usage and perform treatments 3 9 5 Laser Emission Indicator After a self test treatment can only begin when...

Страница 60: ...ective housing which prevents unintended access to laser radiation No sections of the housing can be removed without specialized tooling The laser optical path is enclosed by four separate layers of p...

Страница 61: ...0 1927 Laser System Part Number 10 05170 Rev O Page 61 of 92 3 10 Labeling The Fraxel Laser Systems contain the required manufacturing warning labels The location positioning and formatting of labels...

Страница 62: ...el 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 62 of 92 Regulatory Compliance Labels The location positioning and formatting of labels are subject to change 1550 nm and...

Страница 63: ...axel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 63 of 92 Regulatory Compliance Labels The location positioning and formatting of labels are subject to chan...

Страница 64: ...Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 64 of 92...

Страница 65: ...axel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 65 of 92 Regulatory Compliance Labels The location positioning and formatting of labels are subject to chan...

Страница 66: ...Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System Part Number 10 05170 Rev O Page 66 of 92...

Страница 67: ...ED WHEN TREATING PATIENTS WITH ANY OF THE FOLLOWING CONDITIONS 4 2 1 Predisposition to post inflammatory hyperpigmentation PIH 4 2 1 1 Prophylactic bleaching regimen for skin types IV to VI for 4 6 we...

Страница 68: ...tion changes following surgery c skin indentations and textural changes following surgery d systemic steroids e g prednisone dexamethasone which should be rigorously avoided prior to and throughout th...

Страница 69: ...ms for safety or efficacy nor is it an endorsement or warranty of the safety or efficacy of these products Physicians should make their own assessment of and decision on the use of any of the informat...

Страница 70: ...ensation within the treatment region as being greater than 1 reapply the topical anesthetic and wait 15 more minutes Repeat until the patient has scored the cold sensation within the treatment region...

Страница 71: ...nt area 4 8 8 Take Before photos 4 8 8 1 Photo set up instructions are available in the Fraxel Treatment Reference Guide 4 8 9 Apply topical anesthetic 4 8 9 1 Wipe treatment area with alcohol 4 8 9 2...

Страница 72: ...New Skin For the Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser System s non ablative wavelengths histology indicates that new epithelium new skin will start to form within about 24 hours bu...

Страница 73: ...similar to sun overexposure which usually dissipates within 1 to 3 hours Post treatment ice packs may be applied to alleviate discomfort Over the counter itch and pain relievers may be used if necessa...

Страница 74: ...possibility for infection exists even with non ablative fractional laser devices such the Fraxel 1550 Fraxel 1927 or Fraxel DUAL 1550 1927 Laser Systems If observed infection should be treated approp...

Страница 75: ...axel 1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Laser Systems as described in Section 10 are to be carried out only by factory qualified engineers or technicians or by individuals who have taken the S...

Страница 76: ...rs the tip Be sure to completely dry the tip prior to attachment to the handpiece Visually inspect the tip for scratches pits or damage Do not use if these conditions exist 5 2 4 Component Replacement...

Страница 77: ...Minneapolis MN 55421 USA Phone 763 788 8278 Fax 763 788 8283 The Durette II Regular is made by Oculoplastik Inc 200 Sauve W Montreal Quebec Canada H3L 1Y9 Phone 888 381 3292 Fax 800 879 1849 6 3 Corn...

Страница 78: ...hipment and the sender will be liable for all costs and delays All decontamination inquiries should be addressed to Solta Customer Service The text of the Decontamination Certificate must include the...

Страница 79: ...s to prevent exposure of laser energy to the eye and unintended skin exposure from either direct or diffusely reflected laser beams In addition precautions must be taken in the surgical environment to...

Страница 80: ...Pulse Energy 70 mJ 70 mJ 20 mJ Maximum Pulsewidth 10 ms 10 ms Pulse Repetition Rate 0 3kHz 0 3kHz 9 2 Console Dimensions in 19 25w x 17 75h x 17 5d cm 48 9w x 45 1h x 44 45d Weight 55 lbs Warning SEV...

Страница 81: ...1550 Fraxel 1927 and Fraxel DUAL 1550 1927 Disposable Tips Contact your local authorized distributor of Solta Medical lasers for more information 9 8 Electromagnetic compatibility and immunity This gu...

Страница 82: ...Electromagnetic environment guidance RF Emissions CISPR 11 Group 1 The Fraxel DUAL 1550 1927 Laser System uses RF energy only for its internal function Therefore its RF emissions are very low and are...

Страница 83: ...longer than 3 m Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 0 5 kV 1 kV lines to lines 0 5 kV 1 kV 2 kV lines to ground 0 5 kV 1 kV lines to...

Страница 84: ...e in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in...

Страница 85: ...the maximum output power of the communications equipment Rated maximum output power watts of transmitter Separation distance meters according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 80...

Страница 86: ...Safety Glasses P N 09 00827 and 09 00828 10 2 Procedure 10 2 1 Connect the PC and the Fraxel 1550 Fraxel 1927 or Fraxel DUAL 1550 1927 Laser System using the Serial Connector Both systems must be OFF...

Страница 87: ...stalled return the shipping containers to Solta with the enclosed shipping documents Warning and Disclaimer Storage at excessively low temperatures such as outdoors in the winter may result in a delay...

Страница 88: ...of the manual Solta recommends a dedicated circuit for the laser system Place the power cord where it cannot become a hazard for example by being tripped over or having sharp objects dropped on it Th...

Страница 89: ...harmful electromagnetic interference caused by medical equipment To avoid interference with other devices use the electrical cord provided with the Fraxel Laser systems and always plug the cord into a...

Страница 90: ...age 90 of 92 12 0 Labeling Symbols Description Symbol Caution Warning See Instructions for Use Authorized Representative in the EU Date of Manufacture Do Not Discard in Trash European Conformity Foots...

Страница 91: ...r radiation Key Switch Power On and Off Heavy Lift with two persons Handpiece Connector Service Key For Service Technicians Only USB port This port is used for system updates upgrades This port is uti...

Страница 92: ...ualified Service Technicians Only Do not insert any cable or wires to any of the service ports as this may potentially cause damage to the equipment No special protection against moisture TUV Rheinlan...

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