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Solta Medical CLEAR + BRILLIANT CB-HP-1440 Operator's Manual

Laser system for 1440 nm and 1927 nm handpieces
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CLEAR + BRILLIANT
®
CLEAR + BRILLIANT
Laser System
Operator Manual
For 1440 nm and Perméa™
(1927 nm) Handpieces
Solta Medical, Inc.
11720 North Creek Parkway N., Suite 100
MDSS GmbH
Bothell, WA 98011 U.S.A.
Schiffgraben 41
30175 Hannover
Germany
Phone (+49) -511-6262 8630
Fax (+49) -511-6262 8633
Customer Service: +1-510-259-5299;
+1-877-782-2286; or
Authorized Distributor
Page 1 of 65
Part P009341-01 Rev B

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Summary of Contents for Solta Medical CLEAR + BRILLIANT CB-HP-1440

  • Page 1 CLEAR + BRILLIANT ® CLEAR + BRILLIANT Laser System Operator Manual For 1440 nm and Perméa™ (1927 nm) Handpieces Solta Medical, Inc. 11720 North Creek Parkway N., Suite 100 MDSS GmbH Bothell, WA 98011 U.S.A. Schiffgraben 41 30175 Hannover Germany...
  • Page 2 Solta Medical, CLEAR + BRILLIANT, Perméa and Intelligent Optical Tracking are trademarks or registered trademarks of Solta Medical, Inc. or its subsidiaries in the United States and other countries. Other names and brands may be claimed as the property of others.

  • Page 3: Table Of Contents

    ® CLEAR + BRILLIANT TABLE OF CONTENTS Warnings, Cautions and Notes ................4 CLEAR + BRILLIANT Laser System Overview ............7 Features of the CLEAR + BRILLIANT Laser System ..........8 CLEAR + BRILLIANT Operating Instructions ............. 16 Definitions ......................30 Contraindication and Risk Information ...............

  • Page 4: Warnings, Cautions And Notes

    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, or may result in unintentional laser exposure, and/or may void any warranty.
  • Page 5 CAUTION: Do not substitute another power cord for the one supplied with the unit. 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 products for a replacement if necessary. Do not pull on the cord to pull the plug out of the socket.
  • Page 6 ® CLEAR + BRILLIANT NOTE: Never block the cooling system vents on the system console. 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 which may cause personal injury or damage to other equipment.

  • Page 7: Clear + Brilliant Laser System Overview

    System for treatment providers. CLEAR + BRILLIANT is a non-ablative laser designed for use in dermatological procedures. This device is part of the family of Solta Medical products utilizing the Fractional Photothermolysis principle. This device consists of a Console and a base handpiece (1440 nm) with the option of purchasing additional add-on handpieces.

  • Page 8: Features Of The Clear + Brilliant Laser System

    ® CLEAR + BRILLIANT Features of the CLEAR + BRILLIANT Laser System The CLEAR + BRILLIANT Laser System contains a laser source in the handpiece. 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 treatment tips which attach to the handpiece.
  • Page 9 ® CLEAR + BRILLIANT Handpiece & Display Handpiece Cable Handpiece Cradle & Self-Test Port ON/OFF Button Blue Acknowledgement Button Page 9 of 65 Part P009341-01 Rev B...
  • Page 10 ® CLEAR + BRILLIANT Back View of the System Console The back of the system includes:  Power Input: A power cord connects the system to the electrical outlet. The power input on the back of the console is a standard IEC 60320 type C14 male connector (within the U.S.), or a hospital grade, grounded power cord.
  • Page 11 ® CLEAR + BRILLIANT System Configuration Screen A mini keyboard with touchpad, see image below, is provided for use with the Clear + Brilliant laser system. The keyboard allows customization of the system by providing access to the system configuration screen. Customers can adjust the system volume and choose preferred language and time zone.
  • Page 12 ® CLEAR + BRILLIANT The language and time zone can be adjusted in the Language/Time Zone tab, see image below. Preferred language and time zone can be selected via drop-down menus using the tracking pad. Press APPLY when you have made desired choices. Press DONE button when all desired adjustments are complete.
  • Page 13 ® CLEAR + BRILLIANT Handpiece and Treatment Tip Two handpieces are available for the Clear + Brilliant laser system: the (1440 nm) handpiece and the Perméa (1927 nm) handpiece. The handpiece delivers the laser energy to the surface of the skin through the laser aperture, only if the required treatment tip is in place.
  • Page 14 ® CLEAR + BRILLIANT Top view of Handpiece (with Tip Installed) Treatment Setting Indicator Lights Treatment Setting Selector Button Handpiece Activation Button Treatment Tip A disposable treatment tip attaches to the distal portion of the handpiece and MUST be in place prior to any treatment. The system detects contact between the tip and the skin and translates handpiece motion into velocity information.
  • Page 15 ® CLEAR + BRILLIANT Two (2) latches to connect tip to handpiece Treatment Tip Page 15 of 65 Part P009341-01 Rev B...

  • Page 16: Clear + Brilliant Operating Instructions

    ® CLEAR + BRILLIANT CLEAR + BRILLIANT Operating Instructions Overview This section provides a general guideline for the operation of the CLEAR + BRILLIANT Laser System. This laser system has specific operating requirements. It is the responsibility of the treatment provider to fulfill these requirements.
  • Page 17 ® CLEAR + BRILLIANT Connecting handpiece to the console via the extension cable: Select the desired handpiece. Identify the green dots on the handpiece connector and the mating connector. Align connection ports and tighten the screws to secure connection. CAUTION: Connecting handpiece incorrectly to the extension cable may result in system failure! Identify the green dot on the other end of the extension cable and ensure it is facing upwards, if the console is upright on a flat surface.
  • Page 18 ® CLEAR + BRILLIANT Attach the other end of the extension cable to the back of the console and tighten the screws completely into the console. It is important the connector is attached correctly. If the screws do not tighten all the way, the connector may be attached in reverse. before switching console Remove the connector and reattach, 4.2.3...
  • Page 19 ® CLEAR + BRILLIANT Step-by-Step Operating Instructions ATTENTION! THE CONSOLE MUST BE TURNED OFF PRIOR TO CHANGING FROM ONE HANDPIECE TO THE OTHER AND THEN TURNED ON ONCE DESIRED HANDPIECE IS PROPERLY CONNECTED TO THE CONSOLE. FAILURE TO DO THIS WILL RESULT IN IRREPARABLE DAMAGE TO THE HANDPIECE.
  • Page 20 If the testing is not successful, check the handpiece window for visible damage. If there is no visible damage, try again. If you see damage to the tip, please call Solta Medical Customer Service. If the system does not pass self-test after three tries, contact Solta Medical Customer Service.
  • Page 21 ® CLEAR + BRILLIANT 4.3.3 Treatment Initiation | Insert Treatment Card Upon successful completion of the System Self-Test, the display will immediately transition to the home screen and treatment scan mode (see screen shots below). Page 21 of 65 Part P009341-01 Rev B...
  • Page 22 ® CLEAR + BRILLIANT During this mode, the user will insert the treatment card into the card reader, wait for the card to be validated, and press the blue button (left button) on the front of the console when prompted to use a treatment credit.
  • Page 23 ® CLEAR + BRILLIANT Once the treatment card is successfully validated and a treatment credit properly authorized, a treatment credit will be deducted from the treatment card. A treatment card with valid treatment credits is required to activate the device for treatment and is available only to authorized users of the device.
  • Page 24 ® CLEAR + BRILLIANT 4.3.4 Connect Treatment Tip to Handpiece Once the treatment credit has been authenticated, the display will instruct the user to connect the treatment tip to the handpiece, as shown in the screen shot below. As mentioned in Section 2.5, the treatment tip contains two latches which mechanically, and magnetically, attach to the distal part of the handpiece.
  • Page 25 ® CLEAR + BRILLIANT 4.3.5 Select Treatment Level When the treatment tip is securely in place, the screen will display the following message: The user will press the Treatment Setting Selector Button on top of the handpiece to select the treatment setting (low, medium, or high). Push the button once to select the low setting, twice to select the medium setting, and three times to select the high setting.
  • Page 26 ® CLEAR + BRILLIANT 4.3.5.1. Parameter Selection All operators should be adequately trained in laser safety and should make informed and appropriate selection of treatment parameters. CLEAR + BRILLIANT treatment parameters range from low to high settings, as shown in the table below.
  • Page 27 ® CLEAR + BRILLIANT 4.3.6 Activate Handpiece Once the treatment setting has been chosen, the user will press the handpiece Activator Button, located on top of the handpiece, to activate the laser as instructed on the display screen. After pushing the button, the laser is in emission state and is ready to begin treatment.
  • Page 28 ® CLEAR + BRILLIANT When the treatment has been completed, the following message will be displayed: 4.3.8 Remove and Discard Treatment Tip When treatment is complete, remove the treatment tip by squeezing the sides of the treatment tip to unhinge from the handpiece. Discard the treatment tip according to your local regulations.
  • Page 29 ® CLEAR + BRILLIANT 4.3.9 Turn the System OFF Upon treatment completion, the system will return to the treatment authentication stage. Additional treatments can proceed by repeating the treatment authentication process and using additional treatment credits. If another treatment will be performed immediately after the previous treatment, the above steps can be repeated, beginning with pressing the blue button on the console to use another treatment credit to authenticate the next treatment.

  • Page 30: Definitions

    ® CLEAR + BRILLIANT Definitions This section of the manual should familiarize the treatment provider with terminology which describes aspects of the Fractional Photothermolysis process. It is the responsibility of the treatment provider to fully understand the indications for use, safety considerations and laser function associated with CLEAR + BRILLIANT, and to make decisions regarding the specific application of the Laser System to the individual receiving treatment.
  • Page 31 ® CLEAR + BRILLIANT The IOTS also defines a minimum and maximum velocity of the handpiece to ensure the delivery of the appropriate spot density. These velocity limits are dependent on the treatment level setting. Setting CB-HANDPIECE/ CB-HP-1927 (Perméa) CB-HP-1440 Min Hand Speed = 0.5 cm/sec Min Hand Speed = 0.7 cm/sec Max Hand Speed = 8.0 cm/sec...
  • Page 32 ® CLEAR + BRILLIANT The IOTS allows treatment to be bidirectional. The handpiece may be stopped after one pass and the direction of motion reversed without loss of function. NOTE: It is important that the tip stay in good physical contact and approximately perpendicular to the skin for the IOTS to provide accurate information about contact and velocity.
  • Page 33 Pattern Preview Test It is important for the user to become familiar with the system’s visual and audible feedback indicators. For this purpose, Solta Medical provides “burn paper” with each box of CLEAR + BRILLIANT tips in order for the user to produce a pattern preview test.

  • Page 34: Contraindication And Risk Information

    ® CLEAR + BRILLIANT Contraindication and Risk Information The information which follows is provided by Solta only as an information service to treatment providers and is made available with the understanding that it does not constitute the rendering of medical advice. It also does not constitute an endorsement or warranty of the safety or efficacy of these products.
  • Page 35 ® CLEAR + BRILLIANT if skin is still recovering from a cosmetic procedure, such as a chemical or mechanical peel, or laser resurfacing, if Botox injections, or dermal fillers (such as collagen) have occurred within the past 2 weeks. 6.3.3 Solta has no clinical information or experience concerning the use of CLEAR + BRILLIANT on pregnant women or nursing mothers.
  • Page 36 ® CLEAR + BRILLIANT 6.5.3 Expected Responses to Treatment Expected Responses Description Mild to moderate erythema (redness) typically develops immediately after Erythema (Redness) treatment and diminishes or resolves within 12 to 24 hours after treatment. A small degree of redness may last longer in some cases. Mild to moderate edema (swelling) typically develops immediately after treatment Edema (Swelling) and diminishes or resolves within 12 to 24 hours after treatment.
  • Page 37 ® CLEAR + BRILLIANT Complication Description of Complication The possibility for scarring exists with any laser treatment, even with non- ablative laser devices such as CLEAR + BRILLIANT. Local scarring may Scarring occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing.

  • Page 38: Clear + Brilliant Laser System Safety Information

    ® CLEAR + BRILLIANT CLEAR + BRILLIANT Laser System Safety Information CLEAR + BRILLIANT is classified as a Class 3R laser according to IEC/EN 60825-1. Operators and staff must take precautions to prevent direct exposure of laser energy to the eyes. In addition, precautions must be taken to prevent hazards of fire and electrical injury.
  • Page 39 ® CLEAR + BRILLIANT Optical Safety 7.3.1 Review, become familiar with, and follow the local regulations for the use of lasers and laser safety. 7.3.2 A designated and laser-trained individual(s) and/or treatment provider shall be responsible for enforcing safety guidelines during operation.
  • Page 40 ® CLEAR + BRILLIANT Laser Safety Eyewear 7.4.1 The CLEAR + BRILLIANT laser cannot fire unless the treatment tip rollers are in contact with the skin, making it safe for use without protective eyewear. Laser light is only emitted when the tip is in intimate contact with skin which precludes the emission of errant light energy.
  • Page 41 Servicing CLEAR + BRILLIANT is to be done only by Solta authorized personnel. If service is required call Solta Customer Service or your local authorized distributor of Solta Medical products. CAUTION: Do not position the device so that the rear panel is inaccessible for disconnecting the power cord from the CLEAR + BRILLIANT system.
  • Page 42 ® CLEAR + BRILLIANT Laser Room Access and Remote Door Interlock 7.7.1 Always limit personnel in the treatment room to those essential to the procedure. To protect personnel from possible injury due to entry into the procedure room during treatment, an optional remote door interlock can be connected from the laser system to the procedure room entrance door.
  • Page 43 ® CLEAR + BRILLIANT 7.8.9 Do not move/transport laser system with handpiece attached as handpiece may fall and crack or become damaged. If system needs to be moved/transported, handpiece should be detached and transported separately. Regulatory Compliance and Device Safety Information 7.9.1 Safety Features CLEAR + BRILLIANT provides a means for setting and measuring the...
  • Page 44 ® CLEAR + BRILLIANT 7.9.7 Protective Housing The laser has a protective housing which prevents unintended access to laser radiation. The laser optical path is enclosed in the handpiece. The only exposed laser portal is the laser aperture between the tip rollers when the treatment tip is in place on the handpiece.
  • Page 45 ® CLEAR + BRILLIANT Labels on Handpieces (Catalog Numbers) Labels on Tips Packaging Page 45 of 65 Part P009341-01 Rev B...
  • Page 46 ® CLEAR + BRILLIANT Regulatory Compliance Labels The location, positioning and formatting of labels are subject to change. Page 46 of 65 Part P009341-01 Rev B...
  • Page 47 ® CLEAR + BRILLIANT Regulatory Compliance Labels The location, positioning and formatting of labels are subject to change. T = Time Lag (slow blow) HBC = High Breaking Capacity 1500A (x2) = Two Fuses Page 47 of 65 Part P009341-01 Rev B...
  • Page 48 ® CLEAR + BRILLIANT Page 48 of 65 Part P009341-01 Rev B...

  • Page 49: Clear + Brilliant Laser System Safety Specifications

    ® CLEAR + BRILLIANT CLEAR + BRILLIANT Laser System Safety Specifications Technical Specifications – Original (1440 nm) Handpiece Invisible Laser Radiation IEC 60825-1 Classification Class 3R Wavelength 1440 ± 20 nm; min:1420 max:1460 Maximum Power (average) 2.5 W Maximum Pulse Energy 9 mJ Maximum Pulse width 3 ms...
  • Page 50 < 45000 feet / 13846 meters Compatible Delivery Devices Only use original CLEAR + BRILLIANT Disposable Tips. Contact Solta Customer Service or your local authorized distributor of Solta Medical products for more information. Electromagnetic Compatibility and Immunity This guidance and manufacturer's declaration information pertain to the...
  • Page 51 ® CLEAR + BRILLIANT Guidance and manufacturer’s declaration – electromagnetic emissions The CLEAR + BRILLIANT is intended for use in the electromagnetic environment specified below. The customer or user of the CLEAR + BRILLIANT should assure that it is used in such an environment.
  • Page 52 ® CLEAR + BRILLIANT Guidance and manufacturer’s declaration – electromagnetic immunity (continued) The CLEAR + BRILLIANT is intended for use in the electromagnetic environment specified below. The customer or user of the CLEAR + BRILLIANT should assure that it is used in such an environment.

  • Page 53: Regulatory Compliance

    ® CLEAR + BRILLIANT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CLEAR + BRILLIANT as recommended below, according to the maximum output power of the communications equipment. Rated Separation distance (meters) according to frequency of transmitter maximum...

  • Page 54: Maintenance And Warranty

    ® CLEAR + BRILLIANT 10.0 Maintenance and Warranty The CLEAR + BRILLIANT Laser System 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 55 CLEAR + BRILLIANT 10.2.3 Component Replacement/Service Solta Medical, Inc. offers a full service warranty to cover all necessary modifications, replacements, and repairs for CLEAR + BRILLIANT. Contact Solta Medical Customer Service to confirm return of the device for these purposes.

  • Page 56: Re-Order Information

    ® CLEAR + BRILLIANT 11.0 Re-order Information To reorder accessory or device related items, contact Solta Customer Service or your ® local authorized distributor of Solta Medical products. Device Model/Type Reference: CLEAR + BRILLIANT Laser System Ratings: 100 – 240 VAC, 50 / 60Hz, 2 – 1A Output: Max.

  • Page 57: Shipping, Installation And Set-Up Requirements

    If there is exterior damage, DO NOT ACCEPT OR UNPACK THE SYSTEM. Contact Solta Customer Service or your local representative of Solta Medical products and the shipping company immediately. Store the system indoors and at a temperature similar to the temperature of the facility in which it is to be installed.
  • Page 58 ® CLEAR + BRILLIANT 12.5 Moving the Laser System: 12.5.1 Shut down the laser and then remove the power cord plug from the wall and from the power switch housing in the laser. 12.5.2 Disconnect handpiece from the system console and transport separately.

  • Page 59: Labeling Symbols

    ® CLEAR + BRILLIANT 13.0 Labeling Symbols Description Symbol Caution/Warning: See Instructions for Important information. Please read and follow instructions Unrecoverable Error. Must contact Customer Service Authorized Representative in the EU Catalog Number Serial Number Date of Manufacture Symbol Do Not Discard in Trash European Conformity Refer to instruction manual / booklet Fuse Symbol...
  • Page 60 ® CLEAR + BRILLIANT Description Symbol Type BF Applied Part Emergency Laser Stop Laser Aperture, avoid exposure. Invisible laser radiation Power On and Off Button Handpiece Connector Service Key (For Service Technicians Only) USB port (This port is used for system updates/upgrades.
  • Page 61 ® CLEAR + BRILLIANT Description Symbol This device complies with part 18 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference and (2) This device must accept any interference received, including interference that may cause undesired operation TUV Rheinland logo...
  • Page 62 ® CLEAR + BRILLIANT Description Symbol Do Not Access. No Serviceable Parts. Humidity limitation Temperature limitation Fragile, handle with care Do not stack Avoid moisture Page 62 of 65 Part P009341-01 Rev B...

  • Page 63: Error Messages And Troubleshooting

    ® CLEAR + BRILLIANT 14.0 Error Messages and Troubleshooting SmartCard must remain inside the card Reader. Remove SmartCard from Reader and re-insert into Reader verifying proper card orientation and that light on top of Reader turns green. It is safe to remove SmartCard from the Reader.
  • Page 64 ® CLEAR + BRILLIANT Handpiece temperature must not exceed 40°C. This message will disappear once handpiece temperature is below 40°C. Treatment should continue uninterrupted. If you wish to cancel a treatment, proceed to press blue button on the console. If you reach this message in error, press any button on the handpiece to return to stand-by mode.
  • Page 65 ® CLEAR + BRILLIANT If the ON/OFF button is pressed before a treatment is completed, user is asked to confirm request to turn system off by pressing ON/OFF button again. Please note, if system is turned off before a treatment is complete, the treatment will not be available for future use If you’d like to power system...

This manual is also suitable for:

Clear + brilliant permea cb-hp-1927

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