Solta Medical Fraxel 1550 Operator's Manual
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Solta Medical Fraxel 1550 Operator's Manual

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®
Fraxel
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
®
Fraxel
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 Blvd
Hayward, CA 94545 U.S.A.
Phone: +1 510-782-2286
Customer Service +1 510-782-2286; or
Authorized Distributor
Part Number 10-05170 Rev. O
Page 1 of 92

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  • Page 1 Laser Systems Operator Manual Fractional Resurfacing with IOTS ® Intelligent Optical Tracking System Manufactured by Solta Medical, Inc. 25881 Industrial Blvd Hayward, CA 94545 U.S.A. Phone: +1 510-782-2286 Customer Service +1 510-782-2286; or Authorized Distributor Part Number 10-05170 Rev. O...
  • Page 2 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 1927 and Fraxel DUAL 1550/1927 Laser Systems are covered by U.S. Patents 5,897,549 and 6,083,217, 7,282,060, 7,372,606;...
  • Page 3 Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems THE SOLTA MEDICAL FRAXEL 1550 (previously known as the Fraxel re:store, 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...

  • Page 4: Table Of Contents

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Table of Contents     SYSTEM OVERVIEW ......................... 7      ..........................  8 NDICATIONS FOR USE      .............................  9 EVICE  VERVIEW      ........................  9 NTRODUCTION TO THE  YSTEM      ..........................  1 3 ONTROL  EATURES    ...
  • Page 5 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System      ..........................  7 5 LEANING  ROCEDURES      .........................  7 6 ISPOSAL AND  ECYCLING     RE‐ORDER INFORMATION ......................  7 7       ............................  7 7 CCESSORIES      ...
  • Page 6 This operator’s manual contains certain warnings, cautions and notes designed to alert the operator to the proper care and use of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems, (hereinafter referred to as “Fraxel Laser Systems”) and accessories.

  • Page 7: System Overview

    1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 1.0 System Overview This manual provides operating instructions for the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems for physicians and qualified operators under physician supervision. Section 1 of this manual will provide a brief description of the laser systems and their major components.

  • Page 8: Indications For Use

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Indications for use The Fraxel 1550, Fraxel 1927, and Fraxel DUAL 1550/1927 Laser Systems are approved for the following Indications for Use: Geographic Indications for Use Regions For the...

  • Page 9: Device Overview

    Introduction to the System The Fraxel 1550 and Fraxel 1927 systems both have a single fiber laser source, and the Fraxel DUAL 1550/1927 Laser System has two fiber laser sources. The fiber laser controls are contained in a single console.
  • Page 10 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Umbilical Cord and Support Arm Key Switch Emergency switch Front Console with Zimmer Cart Part Number 10-05170 Rev. O Page 10 of 92...
  • Page 11 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Calibration Port Power Connection Footswitch Connection Remote Door Interlock Product Labeling and Identification Locking Casters Rear Console with Cart Part Number 10-05170 Rev. O Page 11 of 92...
  • Page 12 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Treatment Handpiece with Cool Roller Tip installed (Focal cooling not available on all models) Part Number 10-05170 Rev. O Page 12 of 92...

  • Page 13: Control Features

    The screen allows the operator to interact with the device. It displays the information associated with the operating conditions, including: Laser ON / OFF, Machine Status, Treatment Wavelength Selection (Fraxel 1550: 1550 nm; Fraxel 1927: 1927 nm and DUAL 1550/1927: 1550 nm or 1927 nm), Laser Parameters for treatment, Information Messages, Error Messages and System Prompts.
  • Page 14 Do not use the power cord if it becomes frayed or damaged in any way. Contact Solta Medical or your local authorized distributor of Solta Medical lasers for a replacement, if necessary. Do not pull on the cord to pull the plug out of the socket.

  • Page 15: System States

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 1.4.8 Cart The cart serves as a platform for the console when counter space is limited. The cart has wheels which allows for better mobility when moving the laser system, and drawers available for storage of accessories.

  • Page 16: System Operation

    2.0 System Operation Overview This section provides a general guideline for the operation of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems. These laser systems have specific operating requirements. It is the physician’s responsibility to fulfill these requirements.
  • Page 17 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Warning: All personnel within the Nominal Ocular Hazard Distance (NOHD) must be wearing approved eye protection at this point. Failure to wear appropriate eyewear increases the risk of serious eye injury. Warning: Laser equipment not in use should be protected against unauthorized operation by removing the key from the key switch.

  • Page 18: System State Descriptions

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System System State Descriptions This section provides a general overview of the Fraxel Laser Systems operation. These laser systems have specific operating requirements. It is the responsibility of the physician to fulfill these requirements. Failure to do so can result in incorrect and/or intermittent operation or damage to the laser.
  • Page 19 If the testing is not successful, check the internal window and calibration port window for damage, check the handpiece seating in the port to make sure it is correctly placed, and try again, to a maximum of 3 times. After three attempts, contact Solta Medical Customer Service.
  • Page 20 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 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 system parameters to be selected, including Treatment Wavelength. Fraxel DUAL 1550/1927 Home screen Part Number 10-05170 Rev.
  • Page 21 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Fraxel 1550 Home screen Part Number 10-05170 Rev. O Page 21 of 92...
  • Page 22 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Fraxel 1927 Home screen The following parameters may be 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.
  • Page 23 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 2.3.3 Simulate Simulate Mode allows the user to simulate treatment but without discharging laser energy. It is used during the training phase for new operators of the Fraxel Laser Systems and should be utilized fully before the first patient treatment is performed.
  • Page 24 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Part Number 10-05170 Rev. O Page 24 of 92...
  • Page 25 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 2.3.4 Treat Warning: Do not lift the handpiece from treatment area with the footswitch depressed during treatment as this may result in injury to the patient due to 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.
  • Page 26 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 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 treatment settings as desired, and then must press “Ready” in order to exit Standby and enter Treat mode.
  • Page 27 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System In order to initiate treatment, the Operator must depress the footswitch and initiate handpiece motion. Part Number 10-05170 Rev. O Page 27 of 92...
  • Page 28 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 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, the screen will reflect that laser energy is emitted and treatment is occurring.
  • Page 29 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System In order to change treatment parameters or interrupt treatment, the Operator must select “Standby”. The touch screen display will then indicate that the system is in Standby mode. Part Number 10-05170 Rev. O Page 29 of 92...
  • Page 30 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System When in Standby, treatment parameters may be selected. Energy, treatment level and number of passes are described in the table below. After selections are made, the Operator must press “Ready” in order to exit Standby and re-enter Treat mode. Symbol Interpretation The Pulse Energy Level Indicator field should...
  • Page 31 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System The Handpiece Velocity Indicator displays handpiece velocity in cm/s. - White zone indicates normal operation - Black zone indicates under-treatment Tip information displays the amount of lifetime that the currently installed tip has remaining Part Number 10-05170 Rev.
  • Page 32 1927nm: 10mJ & 20mJ, TL7, 8 passes  Perform only 1 pass for the test If lines are missing do not perform treatment and contact Solta Medical Customer Product Support immediately. Performing Pattern Preview Test Test paper with lines missing Part Number 10-05170 Rev.

  • Page 33: Measurement-Guided Dosimetry

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Measurement-Guided Dosimetry To ensure precise treatment dosimetry, actual and estimated kJ readings will be provided in the kJ counter section on the bottom left corner of the touch screen. The “actual kJ” reading will appear on the touch screen after treatment is completed.
  • Page 34 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 2.4.3 Measurement Process The Operator must establish contact between the handpiece and the surface of the treatment region. Vertical and horizontal measurements must be completed as directed by 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.
  • Page 35 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 2.4.4 Measurement Example: Facial Surface Area In order to measure facial surface area, the Operator will be prompted to complete measurements along the vertical and horizontal axes. The length measurement should be completed by administering a pass that begins at the lateral hairline and extends along the vertical axis to the jawline.
  • Page 36 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System The Operator shall measure the width of one half of the face. In order to begin, the Operator must place the tip at the center of the philtrum (depression extending 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).
  • Page 37 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System After completion of all necessary measurements, the touch screen display will list the “Estimated kJ” value and the treatment area measurement (cm ). If the surface area needs to be recalculated, the Operator must select “reset all” and will need to perform the measurements again.
  • Page 38 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 2.4.5 Interpreting “Estimated kJ” Values The “Estimated kJ” value provided by the system is calculation-based. The calculated energy estimate incorporates the surface area of the treatment region, as measured by the Operator, and the intended treatment level.

  • Page 39: Definitions

    “The directions for use provided in this section are based on the results of a clinical trial conducted by Solta Medical, Inc. A total of 27 subjects received a total of 4 non-ablative Part Number 10-05170 Rev. O...

  • Page 40: Total Treatment Density

    The handpiece may get warm during treatment. This is normal and not typically a cause for concern. If the handpiece gets abnormally hot, discontinue treatment and call Solta Customer Service or your local authorized distributor of Solta Medical lasers. Warning: The tones generated by the machine indicate normal function.

  • Page 41: Handpiece Tracking (Iots - Intelligent Optical Tracking® System)

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Warning: Release the footswitch prior to lifting handpiece from the treatment area. Failure to do this may result in burns or injury to the patient due to inadvertent laser exposure. Handpiece Tracking (IOTS –...

  • Page 42: Tip Selection, Cleaning And High Level Disinfection Procedure

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Warning: The tones generated by the machine indicate normal function. If the tone is unchanging but hand velocity is changing, stop treatment to reduce the risk of injury to the patient. Test the system in Simulate mode.
  • Page 43 With the tip removed, wipe the handpiece window with 70% isopropyl alcohol and inspect for debris and other contamination. 2.10.4 High Level Disinfection Procedure Solta Medical has tested and qualified a disinfection method using Cidex OPA, which disinfects the tips to the reusable medical device classification of high level disinfection for semi-critical devices. Warning: Wear gloves and other appropriate body protection as directed by the materials safety data sheets (MSDS) and instructions for use accompanying Cidex®...
  • Page 44 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Warning: Do not allow the chip inside the tip to come into contact with any liquid such as the ® Cidex OPA solution, or water. Do not allow the metal part of the handpiece to come into prolonged contact with any ®...

  • Page 45: Normal Shut-Down Procedure

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System More details 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 the support arm. 2.11.2 Turn off the unit at the key switch.

  • Page 46: 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.

  • Page 47: General Considerations And Hazard Potential

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System General Considerations and Hazard Potential Laser light presents a severe eye and burn hazard to physician, patient and bystanders, and has a potential for starting a fire. In order to avoid injury, avoid unintentional exposure to the laser beam.
  • Page 48 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 3.2.1 A designated Facility Laser Safety Officer (F-LSO) and the physician shall control and enforce the safety aspects of the laser in the health care facility. 3.2.2 A fire extinguisher shall always be available to extinguish any flames.

  • Page 49: Optical Safety

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Optical Safety 3.3.1 The designated Facility Laser Safety Officer (F-LSO) and physician shall control and enforce the safety aspects of the laser in the health care facility. 3.3.2 The F-LSO and physician are responsible for determining the appropriate Nominal Ocular Hazard Distance (NOHD), Nominal Hazard Zone (NHZ) and Maximum Permissible Exposure (MPE) per ANSI Standard Z136.1-2000, Z136.3-2005 and/or IEC 60825-1.
  • Page 50 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Fraxel 1927 or Fraxel DUAL Fraxel 1550 1550 nm 1550/1927 Parameter Laser Output 1927 nm Laser Output Power (Φ) 30 W 12 W Beam Waist Diameter (a) 63 (microns 1/e) 537 (microns 1/e) Divergence (°)
  • Page 51 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 3.3.11 Protective eyewear of the correct optical density for the laser wavelength must be worn at all times during the laser procedure and during laser verification and calibration. 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.
  • Page 52 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Warning: All persons within the NOHD shall wear appropriate eye protection with a minimum optical density of 4.58. For operators complying with EN 207, all persons shall wear eyewear with a protection class of DL4.

  • Page 53: Operation Of The Laser System

    Operation of the Laser System Warning: This manual is not intended to be a complete guide to the use of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems. Solta 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 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 3.4.6 Do not allow the tip to lose contact with the skin during treatment. 3.4.7 The audible tones emitted by the unit during treatment are an indication of hand velocity. If you are moving your hand at different velocities, but you hear an unchanging monotonic sound, stop treatment immediately.

  • Page 55: Electrical Safety

    CAUTION: Unauthorized calibration of this device, or the use of controls or adjustments to performance not specified or approved by Solta Medical could cause injury or harm to the patient, or may result in unintentional laser exposure, or may void any warranty.

  • Page 56: Laser Treatment Controlled Area (Ltca) Information

    Note that a material that appears opaque to the eye may not be opaque at the treatment wavelength. Most common ordinary window glass will allow the laser wavelength used in the Solta Medical Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems to escape. Warning: Do not attempt to coil the umbilical beyond the resistance point of the armoring.

  • Page 57: Proper Laser Routine Maintenance, Handling, And Storage

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 3.7.3 Access to the remote door interlock is through a plug and socket located on the back panel of the laser. The appropriate pin-outs and wiring are shown in the figure below. The laser system is delivered with this plug shorted internally.
  • Page 58 Cidex OPA or other chemically aggressive cleaning solutions of chemicals. 3.8.14 Solta Medical suggests that the operators clean and disinfect the exterior chassis of the laser system with a soft cloth dampened with mild soap and water. Warning: Inspect the handpiece umbilical armoring for damage on a routine basis.

  • Page 59: Regulatory Compliance And Device Safety Information

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Regulatory Compliance and Device Safety Information 3.9.1 Features The Fraxel Laser Systems provide a means for setting and measuring the laser output of each laser source, and also contains the required interlock connectors, key control, and labeling.
  • Page 60 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 3.9.9 Remote Interlock Connector The remote interlock connector permits the operator to connect a remote barrier interlock, remote emergency stop switch, or similar device. The interlock is wired internally such that, when the terminals of the connector are open, the laser is disabled to prevent laser emission.

  • Page 61: Labeling

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 3.10 Labeling The Fraxel Laser Systems contain the required manufacturing warning labels. The location, positioning and formatting of labels are subject to change. Emergency Stop Button Part Number 10-05170 Rev. O Page 61 of 92...
  • Page 62 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Regulatory Compliance Labels The location, positioning and formatting of labels are subject to change. 1550 nm and 1927 nm 1550 nm Part Number 10-05170 Rev. O Page 62 of 92...
  • Page 63 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Regulatory Compliance Labels The location, positioning and formatting of labels are subject to change. Part Number 10-05170 Rev. O Page 63 of 92...
  • Page 64 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Part Number 10-05170 Rev. O Page 64 of 92...
  • Page 65 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Regulatory Compliance Labels The location, positioning and formatting of labels are subject to change. Part Number 10-05170 Rev. O Page 65 of 92...
  • Page 66 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Part Number 10-05170 Rev. O Page 66 of 92...

  • Page 67: Physician Information

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 4.0 Physician Information Warning: The information which follows below is provided by Solta only as an information service to physicians and is made available with the understanding that it does not constitute the rendering of medical advice.

  • Page 68: Contraindications

    Tissue Interaction In skin, water is the primary absorber (chromophore) of the 1550 nm and 1927 nm laser wavelengths used in the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems. Tissue damage can occur with the application of incorrect laser energy settings, incorrect use of the handpiece or inappropriate pretreatment regimens.

  • Page 69: Pre-Treatment Patient Recommendations

    An example of a test of an anesthesia protocol as performed by a physician skilled in the use of a Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems might be: “After the anesthetic has been administered to the treatment area for an appropriate period of time, perform a sensitivity test to gauge readiness for treatment.
  • Page 70 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System treatment on a scale from 0 to 5, with “0” equal to no sensation of cold and “5” equaling the sensation of cold felt on the non-treated region. If the patient scores the sensation within the treatment region as being greater than 1, reapply the topical anesthetic and wait 15 more minutes.

  • Page 71: Patient Preparation

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Patient Preparation 4.8.1 Ensure patient does not have any contraindications 4.8.2 Have patient sign consent forms 4.8.3 Provide verbal and written post-procedure care instructions to patient 4.8.4 Prepare patient record forms 4.8.4.1 Treatment record forms are located in the Treatment Form section of the Fraxel Treatment Reference Guide...

  • Page 72: Spot Treatments

    4.11.1 Protecting 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, but that it will remain covered by the old stratum corneum and MENDS from 4 -14 days.

  • Page 73: Treatments Required And Treatment Intervals

    4.13 Complaints and Adverse Effects Complaints and Adverse Events are reportable under FDA Guidelines. Solta Medical follows MDR (Medical Device Reporting) rules for complaint and adverse event handling. Solta Customer Service should be contacted if the Fraxel Laser Systems are involved in a complaint or adverse event.

  • Page 74: Complications

    1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 4.14 Complications The following complications may be associated with the non-ablative Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems. This is not intended to be an all- inclusive list, nor a substitute for an informed consent form, which should be provided to every patient.

  • Page 75: Maintenance And Warranty

    1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 5.0 Maintenance and Warranty The Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems should not require any specific maintenance by the operator. Routine regular preventative maintenance should be performed on the system as described in this manual. The device is covered by the warranty described in the Solta Master Purchase Agreement and the included attachments thereto, such as the Terms and Conditions of Sale.

  • Page 76: Disposal And Recycling

    Do not dispose of laser console as unsorted municipal waste. End of life electrical / electronic equipment must be collected separately to prevent ill effects to the environment and human health. Contact your local recycling facility for separate collection or Solta Medical, Inc. for appropriate disposal information. Part Number 10-05170 Rev. O...

  • Page 77: Re-Order Information

    1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 6.0 Re-order Information To reorder accessory items contact Solta Customer Service or your local authorized distributor of Solta Medical™ lasers. Accessories Accessory items include: Large (15mm) Cool Roller treatment & replacement tips...

  • Page 78: Decontamination Of Returned Equipment

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 7.0 Decontamination of Returned Equipment US Federal Postal and Transportation Law (Postal Law Title 18, US Code Section 1716, Department of Transportation Rules CFR 49, Section 173.386 and 173.387) mandates that equipment returned to Solta for repair or return must be properly decontaminated with a chemical cleared for use as a “Hospital Disinfectant”...

  • Page 79: Safety Standards And Regulatory Classifications

    Classifications General Standards The Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems are compliant to and have been certified as meeting the following FDA, CDRH standards. Formal compliance certifications to the IEC 60601-1 based standards will be obtained through TUV Rheinland of N.A.

  • Page 80: Fraxel Laser Systems Specifications

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 9.0 Fraxel Laser Systems Specifications Treatment Beam Invisible Laser Radiation Invisible Laser Radiation Product Fraxel 1550 Fraxel 1927 and Fraxel DUAL 1550/1927 Equipment Class I Class I classification IEC60601-1...

  • Page 81: Laser Safety Eyewear

    Altitude < 45000 feet / 13846 meters Compatible Delivery Devices Only use original Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Disposable Tips. Contact your local authorized distributor of Solta Medical lasers for more information. Electromagnetic compatibility and immunity This guidance and manufacturer's declaration information pertains to the following Solta...
  • Page 82 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System  It is not normally affected by nearby equipment and devices.  It is not safe to operate the Fraxel DUAL 1550/1927 Laser System in the presence of high-frequency medical equipment. ...
  • Page 83 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Guidance and manufacturer’s declaration – electromagnetic immunity The Fraxel DUAL 1550/1927 Laser System is intended for use in the electromagnetic environment specified below. The customer or user of the Fraxel DUAL 1550/1927 Laser System should assure that it is used in such an environment.
  • Page 84 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Guidance and manufacturer’s declaration – electromagnetic immunity (continued) The Fraxel DUAL 1550/1927 Laser System is intended for use in the electromagnetic environment specified below. The customer or user of the Fraxel DUAL 1550/1927 Laser System should assure that it is used in such an environment.
  • Page 85 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Recommended separation distances between portable and mobile RF communications equipment and the Fraxel DUAL 1550/1927 Laser System The Fraxel DUAL 1550/1927 Laser System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 86: External Factory Calibration Instructions

    Regulations state that laser-based devices that are classified as CDRH Class 4 shall have instructions for external Factory Calibration of the power output. External Factory Calibration of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems must be performed by a factory-qualified engineer or technician. Please contact Solta Customer Service with questions relating to the external power calibration of the Fraxel laser.

  • Page 87: Shipping, Installation And Set-Up Requirements

    11.0 Shipping, Installation and Set-Up Requirements 11.1 Shipping The Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems will be shipped in a specially designed container. When the shipment is received, inspect the exterior container for damage. Inspect the shock indicators for indications of shipping damage. If there is exterior damage, DO NOT ACCEPT OR UNPACK THE SYSTEM.

  • Page 88: Environmental

    104°F / 40ºC is allowed. The cooling system for the laser is forced air, and no other external utilities are required. The Fraxel 1550 and Fraxel DUAL 1550/1927 Laser Systems will emit a maximum of 600W / 2050BTUh into the environment around the console.
  • Page 89 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 11.5.4 Using the console handle, move the system to the new location. Be careful when pushing the unit over elevator thresholds, carpet-linoleum interfaces, and other step-like features in the path of motion. Do not allow the unit to tip over when in motion.

  • Page 90: Labeling Symbols

    ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 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 Footswitch Fuse Manufacturer Type “B”...
  • Page 91 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Description Symbol ESD Sensitive Device Laser Aperture, Avoid exposure. Invisible laser 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.
  • Page 92 ® Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System Description Symbol Communication Connectors (These ports are used in case a system error has occurred. This port is utilized by qualified 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 Rheinland logo...

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