Fraxel series Operator Manual Rev O

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

This manual may not be copied, translated, or reproduced in whole or in part without the express written consent of Solta Medical, Inc. (henceforth “Solta”). Solta Medical™, Fraxel, the Fraxel logo and Intelligent Optical 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 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; 7,646,522, D604,843, D601,697 and foreign equivalents and by patents pending. Cidex® and Enzol® are registered trademarks of Johnson and Johnson, Inc.

© Solta Medical, Inc. June 2013 Published in the USA

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Solta Medical, Inc. 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 USE ONLY BY PROPERLY TRAINED PHYSICIANS AND PROPERLY TRAINED PERSONS UNDER THE SUPERVISION OF SUCH A TRAINED PHYSICIAN (HENCEFORTH “THE PHYSICIAN”).

PLEASE READ THE SOLTA MEDICAL FRAXEL 1550, FRAXEL 1927 AND FRAXEL DUAL 1550/1927 LASER SYSTEMS OPERATORS MANUAL IN ITS ENTIRETY PRIOR TO USE OF THE LASER SYSTEM.

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Table of Contents 1.0 1.1 1.2 1.3 1.4 1.5 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 5.0 5.1

SYSTEM OVERVIEW ... 7 INDICATIONS FOR USE ...8 DEVICE OVERVIEW ...9 INTRODUCTION TO THE SYSTEM ... 9 CONTROL FEATURES ...13 SYSTEM STATES ...15 SYSTEM OPERATION ...16 OVERVIEW ...16 ROUTINE PRECAUTIONS PRIOR TO TREATMENT ... 16 SYSTEM STATE DESCRIPTIONS ... 18 MEASUREMENT‐GUIDED DOSIMETRY ... 33 DEFINITIONS ...39 PARAMETER SELECTION ... 39 TOTAL TREATMENT DENSITY (TOTAL MTZS / CM2) ... 40 SYSTEM AUDIBLE FEEDBACK ... 40 HANDPIECE TRACKING (IOTS – INTELLIGENT OPTICAL TRACKING® SYSTEM) ... 41 TIP SELECTION, CLEANING AND HIGH LEVEL DISINFECTION PROCEDURE ... 42 NORMAL SHUT‐DOWN PROCEDURE ... 45 SAFETY ...46 GENERAL CONSIDERATIONS AND HAZARD POTENTIAL ... 47 FIRE PRECAUTIONS ...47 OPTICAL SAFETY ...49 OPERATION OF THE LASER SYSTEM ... 53 ELECTRICAL SAFETY ...55 LASER TREATMENT CONTROLLED AREA (LTCA) INFORMATION ... 56 LASER SUITE ACCESS AND REMOTE DOOR INTERLOCK ... 56 PROPER LASER ROUTINE MAINTENANCE, HANDLING, AND STORAGE... 57 REGULATORY COMPLIANCE AND DEVICE SAFETY INFORMATION ... 59 LABELING ...61 PHYSICIAN INFORMATION...67 INDICATIONS FOR USE ... 67 CONSIDERATIONS ...67 CONTRAINDICATIONS ...68 TISSUE INTERACTION...68 PRE‐TREATMENT PATIENT RECOMMENDATIONS ... 69 PRE‐OPERATIVE INSPECTION ... 69 ANESTHESIA ...69 PATIENT PREPARATION ... 71 SPOT TREATMENTS...72 IMMEDIATE POST‐OPERATIVE CARE... 72 POST‐OPERATIVE INFORMATION ... 72 TREATMENTS REQUIRED AND TREATMENT INTERVALS ... 73 COMPLAINTS AND ADVERSE EFFECTS ... 73 COMPLICATIONS ...74 MAINTENANCE AND WARRANTY...75 WARRANTY INFORMATION ... 75

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Fraxel® 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System 5.2 5.3 6.0 6.1 6.2 6.3 6.4 6.5

CLEANING PROCEDURES ... 75 DISPOSAL AND RECYCLING ... 76 RE‐ORDER INFORMATION ...77 ACCESSORIES...77 *EXTERNAL STEEL EYE PROTECTION ... 77 *CORNEAL SHIELDS ...77 *CORNEAL SHIELD LUBRICATION GEL ... 77 *TOPICAL CORNEAL ANESTHETIC ... 77

7.0

DECONTAMINATION OF RETURNED EQUIPMENT...78

8.0

SAFETY STANDARDS AND REGULATORY CLASSIFICATIONS ...79

8.1 9.0

GENERAL STANDARDS ... 79 FRAXEL LASER SYSTEMS SPECIFICATIONS...80

9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8

TREATMENT BEAM ...80 CONSOLE ...80 LASER SAFETY EYEWEAR ... 81 CART ...81 OPERATING ENVIRONMENT... 81 SHIPPING AND STORAGE (NON‐OPERATIONAL) ... 81 COMPATIBLE DELIVERY DEVICES ... 81 ELECTROMAGNETIC COMPATIBILITY AND IMMUNITY ... 81

10.0

EXTERNAL FACTORY CALIBRATION INSTRUCTIONS ...86

10.1 10.2 11.0 11.1 11.2 11.3 11.4 11.5 12.0

TOOLS AND PARTS REQUIRED ... 86 PROCEDURE ...86 SHIPPING, INSTALLATION AND SET‐UP REQUIREMENTS ...87 SHIPPING...87 INSTALLATION ...87 SPACE REQUIREMENTS ... 87 ENVIRONMENTAL ...88 ELECTRICAL ...88 LABELING SYMBOLS ...90

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Warnings, Cautions, and Notes Please note that the Fraxel 1550 was previously known as the Fraxel re:store and the Fraxel DUAL 1550/1927 was previously known as the Fraxel re:store DUAL. 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. This manual refers to the Fraxel 1550, the Fraxel 1927 and the Fraxel DUAL 1550/1927 laser systems unless specifically stated. The cool roller tip / focal cooling feature described in this manual is not available on all models. The 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 importance. Failure to observe the instructions in these alerts could result in serious injury, fire, or damage to the laser system or surrounding equipment. CAUTION: The “CAUTION: Box” alerts the operator to proper operation and proper use of the Fraxel Laser Systems and their accessories. Note: The “Note: Box” designates information of special interest.

Warning: PLEASE READ THE FRAXEL LASER SYSTEMS OPERATOR’S MANUAL IN ITS ENTIRETY PRIOR TO USE OF THE SOLTA FRAXEL 1550, FRAXEL 1927, OR FRAXEL DUAL 1550/1927 LASER SYSTEMS. PLEASE CONTACT SOLTA CUSTOMER SERVICE AT +1 510-782-2286 OR YOUR LOCAL AUTHORIZED DISTRIBUTOR OF SOLTA MEDICAL LASERS IF YOU HAVE ANY QUESTIONS. ALL OPERATORS ARE REQUIRED TO PARTICIPATE IN FRAXEL LASER SYSTEMS TRAINING PROGRAM PRIOR TO STARTING INDEPENDENT TREATMENTS.

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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. The Fraxel Laser Systems should only be used by physicians and staff who have been appropriately trained and who are thoroughly familiar with the instructions and 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-US MC-SYS-SR1500-D-INTL MC-SYS-SR1500-D-UPG-INTL MC-SYS-SR1500-P-INTL MC-SYS-SR1500-P-UPG-INTL MC-SYS-SR1500-CPO-INTL MC-SYS-SR1900-US MC-SYS-SR1900-INTL Please note there are two differences between the International and Domestic systems: 1) 2)

An additional laser “Door Warning Sign” is shipped with International systems There are two different power cords: a. Part # 08-01615 for International b. Part # 08-00475 for Domestic

PLEASE CONTACT SOLTA MEDICAL CUSTOMER SERVICE AT +1 510-782-2286 OR CONTACT YOUR LOCAL AUTHORIZED DISTRIBUTOR OF SOLTA MEDICAL LASERS IF YOU HAVE QUESTIONS.

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1.1

Indications for use

The Fraxel 1550, Fraxel 1927, and Fraxel DUAL 1550/1927 Laser Systems are approved for the following Indications for Use: Geographic Regions For the following geographic region: U.S.A.

Indications for Use 1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Fraxel 1927 nm laser is 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), solar lentigos (sun spots) and ephelides (freckles).

For the following geographic regions: Australia Brazil Canada EU Hong Kong India Japan Korea Mexico Russia Philippines Singapore Taiwan Thailand UK Vietnam

1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Fraxel 1927 laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis

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1.2

Device Overview

The Fraxel Laser Systems are designed for cutaneous laser treatment. These devices are part of the family of Solta Medical products utilizing the Fractional Photothermolysis principle. The Fraxel 1550 consists of a single infra-red fiber laser with wavelength of 1550 nm. The Fraxel 1927 consists of a single infra-red Thulium fiber laser with wavelength of 1927 nm. The Fraxel DUAL 1550/1927 Laser System has two infra-red fiber lasers with wavelengths of 1550 nm and 1927 nm. The two wavelength option allows for targeted treatment of different tissue depths. The 1550 nm laser coagulates the epidermis and dermis with up to 1.6 mm depth of penetration. The 1927 nm laser coagulates epidermis and superficial dermis with up to 0.3 mm depth of penetration. The laser sources are controlled by an embedded processor. The solid state design of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems typically result in limited maintenance and minimal utilities requirements. The output of the fiber laser is focused into the skin using lenses contained within the handpiece. Computer controlled motors within the handpiece and the software control architecture direct the laser system to deliver focused spots in an evenly spaced treatment pattern. 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 intended to allow for treatment of smaller areas (not available with all systems). This manual is intended to help you get the most from your system as you make the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems an integral part of your practice. It is our intention that the information provided assists the operator in successful use of this product. This manual is not intended to substitute for training by authorized Solta Medical personnel prior to treatment of patients. If you have additional questions, please contact your local Solta Customer Service representative directly.

Warning: The Fraxel Laser Systems generate an intense beam of laser radiation which may cause injury if not used properly. It is essential that this manual be read thoroughly and understood in its entirety before operation.

1.3

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. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the handpiece. Contact with the tissue is maintained by removable disposable contact tips which attach to the handpiece. The features of the Fraxel Laser Systems are shown below:

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Umbilical Cord and Support Arm

Key Switch

Emergency switch

Front Console with Zimmer Cart

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Calibration Port

Power Connection Footswitch Connection Remote Door Interlock Product Labeling and Identification

Locking Casters

Rear Console with Cart

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Treatment Handpiece with Cool Roller Tip installed (Focal cooling not available on all models)

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1.4

Control Features 1.4.1

On/Off Key Switch

The On/Off key switch turns the Laser System on and off. The key should always be kept in a safe place (and not in the key switch), when not in use, to avoid unauthorized use by untrained personnel and the possibility of injury or fire. 1.4.2

Touch Screen Display

The touch screen serves as the information center for the Fraxel Laser Systems. 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. 1.4.3

Emergency Stop Button

There is a red emergency stop button in the front center of the console. Press this button 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 software. CAUTION: The handpiece tip must be removed from the handpiece prior to calibration. Take precautions to ensure that neither the handpiece internal sealing window nor the tip window become contaminated before, during, or after the calibration procedure as this may result in poor clinical outcome, damage to the machine or injury to the physician or patient.

1.4.5

Umbilical Cord and Support Arm

The umbilical cord is managed by the adjustable support arm. When using focal cooling with the Cool Roller Tip, the Zimmer cool air delivery hose may be clipped onto the electrical umbilical cable and draped over the support arm as shown on section 1.3 Ensure that there are no kinks in the hose. CAUTION: Do not attempt to coil the umbilical beyond the resistance point of the armoring. Do not use if the internal cables and wires are visible through holes or gaps in the umbilical armoring as this may cause inadvertent exposure of laser energy to persons in the room.

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1.4.6

Treatment Tip

Removable disposable tips attach to the distal portion of the handpiece and MUST be in place prior to any treatment. The tips are interchangeable and are available in small and large sizes of approximately 7 and 15 mm, respectively. The different sizes allow for treatment of both small and large areas. The system detects contact between the tip and skin and translates handpiece motion into velocity information. The tips have a finite treatment lifetime. When using the tips, ensure that the cooling channel adaptor is clipped onto that side of the handpiece as shown on section 1.3. Connect the distal end of the Zimmer air cooler delivery hose to the white cylinder at the end of the clear tubing. Cool air will flow down the cooling channel into the Cool Roller Tip. The air will flow across the skin between the rollers and exhaust from the opposite side. Inspect tip window for contamination before the tip is installed 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 biological agents from one patient to another. Note: Handpiece tracking could be adversely affected by tip window fogging or condensation. Remove tip from handpiece to observe both sides of the tip window.

CAUTION: The handpiece tip must be attached to the distal portion of the handpiece prior to any treatment. If this is not done, the laser system will not function properly which may result in injury to the physician or patient.

1.4.7

Power Cord

A hospital grade power cord connects the laser to the electrical outlet. The power cord entry on the back of the console is a standard IEC60320 type C14 male connector. The power cord needs to have a standard IEC60320 type C13 female connector. CAUTION: Do not substitute another power cord for the one supplied with the unit or provided by your local representative. 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.

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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. CAUTION: Always lock the wheels prior to operation of the laser.

Warning: If 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 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

Utilities/Home

Allows access to various functional parameters of the system. 1.5.2

System Test Mode

Allows the system and handpiece to be tested. After successful power-on, the system will move to this mode. 1.5.3

Simulate Mode

Allows the user to simulate treatment but without discharging laser energy. 1.5.4

Treat Mode

The system is ready and/or receiving input from the footswitch and handpiece. This mode presents the highest potential risk of injury to the physician and patient. These functions are described in Section 2.0 in the context in which they appear on the screen.

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2.0 System Operation 2.1

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. Failure to do so can result in incorrect and/or intermittent operation or damage to the laser.

2.2

Routine Precautions Prior to Treatment 2.2.1

Affix the laser warning sign, supplied with the system, to the door of the room or the point denoting the perimeter of the Nominal Hazard Zone (NHZ) (see Safety section of this manual).

2.2.2

Ensure that all persons in the NHZ are provided with the appropriate eyewear (see Safety section of this manual).

2.2.3

Take precautions to mitigate the fire hazards associated with the laser system, including the use of fire-retardant curtains, watersoaked 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 available in the treatment room. Connect the power cord to the laser and to the wall socket.

2.2.5

Make sure that the handpiece umbilical cable is not excessively twisted from the unit. Do not tape the umbilical to any structure. Do not attempt to coil the umbilical beyond the resistance point of the armoring. Do not use if the internal cables and wires are visible through holes or gaps in the umbilical armoring as this may cause inadvertent exposure of laser energy to persons in the room. Do not move the unit using the arm.

2.2.6

Check handpiece and tip cleanliness per sections. Do not use tips with damaged windows.

2.2.7

Ensure that the red emergency switch is in disengaged position (not pushed in) to enable the system for start up.

2.2.8

Insert the key into the key switch. Turn the unit on and verify that the unit powers up normally with no error messages. Instructions will appear on the screen to guide the operation of the system.

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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. Keep the key in a designated place accessible only to authorized and trained personnel to avoid unauthorized use by untrained personnel and the possibility of injury or fire.

Warning: Do not attempt to coil the umbilical beyond the resistance point of the armoring. Do not use if the internal cables and wires are visible through holes or gaps in the umbilical armoring as this may cause inadvertent exposure of laser energy to persons in the room.

Warning: If 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 in serious injury or damage to the unit.

Warning: SEVERE DAMAGE TO THE UNIT WILL RESULT FROM IMMEDIATE POWER UP FOLLOWING MOVEMENT OF THE UNIT FROM A COLD ENVIRONMENT INTO A WARM ENVIRONMENT. THIS CONDITION WILL OCCUR IF FOR EXAMPLE THE UNIT IS MOVED FROM LOCATION TO LOCATION ON A DAILY BASIS AND IS STORED IN A SHIPPING CONTAINER, AUTOMOBILE, OR TRUCK OVERNIGHT. THE UNIT MUST BE ALLOWED TO EQUILIBRATE WITH ITS SURROUNDINGS FOR A MINIMUM OF 90 MINUTES FOLLOWING A CHANGE OF ENVIRONMENT. FAILURE TO OBSERVE THESE PRECAUTIONS WILL RESULT IN THE WARRANTY OF THE UNIT BEING VOIDED. NOTE: NEVER BLOCK THE COOLING SYSTEM VENTS. ENSURE ADEQUATE SPACE AROUND THE UNIT AT ALL TIMES TO FACILITATE SYSTEM COOLING. CAUTION: USE OF CONTROLS, ADJUSTMENTS, OR PROCEDURES OTHER THAN THOSE SPECIFIED MAY RESULT IN HAZARDOUS ELECTROMAGNETIC RADIATION EXPOSURE WHICH MAY RESULT IN INJURY, OR DAMAGE TO OTHER EQUIPMENT.

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2.3

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. While powering up, the system 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 appear on the touch screen display. The initial system test screen will direct the placement of the handpiece into the calibration port. In order to perform system testing, remove the tip from the handpiece. Place the tip in a clean, dust-free container while the testing is in progress. Then, proceed by placing the handpiece in the calibration port located on the top right hand side of the laser console. The touch screen will indicate when testing has initiated.

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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. If the system fails to calibrate to within 80% of the requested energy (more than 20% below specification), it will not allow further treatment. Solta Medical then requires that the system be serviced. Repeated power cycling will not clear this fault. Contact Solta Medical Customer Service to schedule service.

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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

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