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Solta Medical thermage CPT TG-2B Technical User's Manual

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Thermage CPT™ System
Model TG-2B
TECHNICAL USER'S
MANUAL
P/N P009240-06
SOLTA MEDICAL, INC.
11720 North Creek Parkway North, Suite 100
BOTHELL, WA 98011
TELEPHONE: +1 510-259-5299, +1 877-782-2286
WWW.SOLTA.COM
September 2021
Solta Medical, Inc.
Page 1 of 80
Copyright © 2021
Part # P009240-06

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  • Page 1 Thermage CPT™ System Model TG-2B TECHNICAL USER’S MANUAL P/N P009240-06 SOLTA MEDICAL, INC. 11720 North Creek Parkway North, Suite 100 BOTHELL, WA 98011 TELEPHONE: +1 510-259-5299, +1 877-782-2286 WWW.SOLTA.COM September 2021 Solta Medical, Inc. Page 1 of 80 Copyright © 2021...

  • Page 2: Copyright Information

    COPYRIGHT INFORMATION © 2021 Solta Medical, Inc. All rights reserved MDSS GmbH SOLTA MEDICAL, INC. Schiffgraben 41 11720 North Creek Parkway 30175 Hannover North, Suite 100 Germany BOTHELL, WA 98011 +49 511-6262 8630 Telephone: +1 510-259-5299 www.mdss.com WWW.SOLTA.COM CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a licensed health care professional only.
  • Page 3 No part of this document may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means – electronic, mechanical, photocopying, recording, or otherwise – without the expressed, written consent of Solta Medical, Inc. Additional copies of this document can be ordered from Solta Medical, Inc. TRADEMARKS Thermage is a registered trademark of Solta Medical, Inc.

  • Page 4: Table Of Contents

    ....................28 andPieCe SSemBly onTrolS ..................30 ndiCaTorS for The andPieCe THERMAGE ACCESSORIES ..................30 ) ......................30 ooTSWiTCh oPTional ..........................30 eTurn ........................30 ryogen aniSTer September 2021 Solta Medical, Inc. Page 4 of 80 Copyright © 2021 Part # P009240-06...
  • Page 5 12.14 m ........................... 68 ainTenanCe 12.15 d ..........................68 iSPoSal 12.16 T ......................68 eChniCal PeCifiCaTionS 13. POWER OUTPUT CURVES ....................69 14. LABELING SYMBOLS ....................76 September 2021 Solta Medical, Inc. Page 5 of 80 Copyright © 2021 Part # P009240-06...
  • Page 6 Figure 10.6 Unlock Reusable Shipping Crate ................53 Figure 10.7 Remove Shipping Crate Lid ..................54 Figure 10.8 Roll System Into Shipping Crate ................54 Figure 10.9 Close and Lock Shipping Crate ................55 September 2021 Solta Medical, Inc. Page 6 of 80 Copyright © 2021 Part # P009240-06...
  • Page 7 Table 6.4 Handpiece Control Buttons ..................29 Table 8.1 How to Adjust System Tools Screen - Menu Options ..........36 Table 11.1 System Messages ....................57 Table 14.1 Labeling Symbols....................76 September 2021 Solta Medical, Inc. Page 7 of 80 Copyright © 2021 Part # P009240-06...

  • Page 8: Introduction

    ‘Handpiece Assemblies’. They have a lifespan of 100,000 pulses. • The Thermage Cryogen Canister will also be referred to as ‘coolant canister’ in this User’s Manual. September 2021 Solta Medical, Inc. Page 8 of 80 Copyright © 2021 Part # P009240-06...

  • Page 9: Indicated Use

    • Temporary improvement of local circulation (i.e., blood circulation). The Thermage CPT system must be operated only by trained and accredited users. Training to be performed by Solta Medical authorized personnel only. 3. Contraindications The Thermage CPT System is contraindicated for use in patients with either an implantable...

  • Page 10: Warnings

    30 cm (12 inches) to any part of the Thermage CPT system, including cables specified by Solta. Otherwise, degradation of the performance of this equipment could result. September 2021 Solta Medical, Inc. Page 10 of 80 Copyright © 2021 Part # P009240-06...

  • Page 11: Precautions

    4.2.10 Prior to delivery of RF energy, apply a generous amount of Thermage Coupling Fluid to the targeted treatment area. Do no use other fluids such as irrigation solutions (e.g. saline, Ringer’s lactate, sterile water). September 2021 Solta Medical, Inc. Page 11 of 80 Copyright © 2021 Part # P009240-06...
  • Page 12 Extension cords and / or adapter plugs must not be used. 4.2.23 Unauthorized or improper service, repair or modifications performed by unauthorized personnel may pose a hazard and will invalidate any warranty agreement. September 2021 Solta Medical, Inc. Page 12 of 80 Copyright © 2021 Part # P009240-06...
  • Page 13 Return Pad on the shoulder, neck, or head region. 4.2.37.2 To ensure better adherence, cleanse the area with a 70% alcohol solution and allow it to completely dry. September 2021 Solta Medical, Inc. Page 13 of 80 Copyright © 2021 Part # P009240-06...
  • Page 14 4.2.38.4 If the patient is repositioned during treatment, always verify the Return Pad maintains contact to the skin in its entirety and the cable connections are not compromised before resuming treatment. September 2021 Solta Medical, Inc. Page 14 of 80 Copyright © 2021 Part # P009240-06...
  • Page 15 4.2.48 Prolonged exposure to sunlight or other sources of heat may cause the canister’s content to vent or burst. 4.2.49 Do not leave Cryogen Canisters in vehicles in which temperatures may rise above 49°C (120°F). September 2021 Solta Medical, Inc. Page 15 of 80 Copyright © 2021 Part # P009240-06...
  • Page 16 Warning: Maintenance is not to be performed while system is in use with the patient. Follow local governing ordinances and recycling plans regarding the recycling or disposal of this equipment and its accessories. September 2021 Solta Medical, Inc. Page 16 of 80 Copyright © 2021 Part # P009240-06...

  • Page 17: Possible Adverse Patient Reactions And Management Options

    Erythema / blanching may occur in mild form and typically resolve within a few hours. However, on rare occasions, erythema has been reported to last longer (up to several weeks). Blanching usually resolves within twenty-four (24) hours. September 2021 Solta Medical, Inc. Page 17 of 80 Copyright © 2021 Part # P009240-06...

  • Page 18: Swelling (Edema)

    Herpes simplex eruption may result in rare cases in a treated area that has previously been infected with the virus. Reactivation of HSV is generally thought to occur most commonly in the perioral and genital skin areas after various stimuli. September 2021 Solta Medical, Inc. Page 18 of 80 Copyright © 2021 Part # P009240-06...

  • Page 19: Thermage Cpt System

    The user is advised to perform thorough, periodic inspections of the System and its accessories. If any physical damage is found, DO NOT USE THE SYSTEM. Contact Solta Medical, Inc., Customer Service at (877) 782-2286 to request a replacement.

  • Page 20: Figure 6.1 Thermage Cpt System

    Thermage CPT System Technical User’s Manual Figure 6.1 Thermage CPT System September 2021 Solta Medical, Inc. Page 20 of 80 Copyright © 2021 Part # P009240-06...

  • Page 21: System Controls, Displays, And Indicators

    [CONTINUE] to confirm the level. Pressing and holding the [ADJUST] button at System startup, or when READY or READY TO TUNE, places the System into SYSTEM TOOLS mode. September 2021 Solta Medical, Inc. Page 21 of 80 Copyright © 2021 Part # P009240-06...

  • Page 22: Figure 6.3 Front Panel Display

    Figure 6.3 shows the System’s front panel. Tables 6.2 and 6.3 show the System’s front panel display indicators and system indicators, respectively. Figure 6.3 Front Panel Display September 2021 Solta Medical, Inc. Page 22 of 80 Copyright © 2021 Part # P009240-06...

  • Page 23: Table 6.2 Front Panel Display Indicators

    (in Joules per cm²) delivered per pulse over the course of the treatment. Comfort The word “Comfort” will appear when the vibratory element of the Handpiece is enabled. September 2021 Solta Medical, Inc. Page 23 of 80 Copyright © 2021 Part # P009240-06...

  • Page 24: Table 6.3 Front Panel System Indicators

    System. The 0.25 cm² and 3.0 cm² Treatment Tips attach to the Face Handpiece with Vibration and the 16.0 cm² Treatment Tip attaches to the Body Handpiece. September 2021 Solta Medical, Inc. Page 24 of 80 Copyright © 2021...
  • Page 25 Vibration should be adjusted based on patient comfort and preference. Warning – Potential Overheating: If the Handpiece becomes excessively hot, discontinue its use and call Solta Medical Customer Service or your local authorized Solta Medical Representative before any further use of the Handpiece. Under normal operating conditions, a Handpiece will become warm, but a continuous increase in temperature is abnormal and could cause injury.

  • Page 26: Figure 6.4 Thermage Cpt Face Handpiece

    Figure 6.4 Thermage CPT Face Handpiece CONTROL PANEL FINGERSWITCH TREATMENT TIP REMOVAL TREATMENT BUTTON Figure 6.5 Thermage CPT Body Handpiece FINGER SWITCH TREATMENT TREATMENT TIP REMOVAL BUTTON September 2021 Solta Medical, Inc. Page 26 of 80 Copyright © 2021 Part # P009240-06...

  • Page 27: Handpiece Cleaning Instructions

    Note: The Handpieces cannot be sterilized. Be sure that the reusable cable and reusable Handpieces have been cleaned prior to use. All listed cleaning methods are recommended by Solta Medical for compatibility with product materials, not for biologic effectiveness. Thermage CPT Treatment Tips Inspect the treatment tips for any signs of physical damage prior to treatment.

  • Page 28: Handpiece Assembly Controls

    Vibration and the Body Handpiece with the exception of the vibration button, which is found only on the Face Handpiece. Figure 6.6 Handpiece Control Buttons September 2021 Solta Medical, Inc. Page 28 of 80 Copyright © 2021 Part # P009240-06...

  • Page 29: Table 6.4 Handpiece Control Buttons

    After setting the Vibration Intensity Level, the operator must then press [CONTINUE] on either the front panel or on the Handpiece before commencing patient treatment. September 2021 Solta Medical, Inc. Page 29 of 80 Copyright © 2021 Part # P009240-06...

  • Page 30: Indicators For The Face Handpiece

    3.00 cm² or 16.00 cm² tip than for a 0.25 cm² tip. The reduction in cryogen volume is also more rapid for higher level settings than for lower settings. September 2021 Solta Medical, Inc. Page 30 of 80 Copyright © 2021...

  • Page 31: Thermage Cpt System Setup Instructions

    Power the System ON using the ON / OFF switch, which is located on the System’s side panel. See Figure 8.2. Figure 8.2 Power Switch September 2021 Solta Medical, Inc. Page 31 of 80 Copyright © 2021 Part # P009240-06...

  • Page 32: Figure 8.3 Installing The Cryogen Canister

    If the screen or indicators fail to light or if no tone is heard, DO NOT USE THE SYSTEM and contact Solta Medical, Inc. for service. If the System goes directly into the FAULT mode upon start-up, DO NOT USE THE SYSTEM and contact Solta Medical, Inc., Customer Service at (877) 782-2286.

  • Page 33: Figure 8.4 System Front Panel

    Insert the Handpiece cable into the Handpiece connection on the System front panel as shown in Figure 8.5. (Push in until the connector clicks.) Figure 8.5 Return Pad Cable (left) and Handpiece (right) connected September 2021 Solta Medical, Inc. Page 33 of 80 Copyright © 2021 Part # P009240-06...

  • Page 34: Figure 8.6 Footswitch Connection

    The port located on the System front panel and inferior to the SD card slot is for use only by Solta-trained service personnel. Inserting anything into this port can cause damage to the CPT System and may lead to injury. September 2021 Solta Medical, Inc. Page 34 of 80 Copyright © 2021 Part # P009240-06...

  • Page 35: System Configuration

    • Sound Style • Remove Handpiece Figure 8.7 Generator SYSTEM TOOLS Screen Note: If the System Tools menu is accessed during treatment, the System must be restarted. September 2021 Solta Medical, Inc. Page 35 of 80 Copyright © 2021 Part # P009240-06...

  • Page 36: Table 8.1 How To Adjust System Tools Screen - Menu Options

    Select the style of audible tone: Comforting or Classic. Remove Select to release cryogen pressure at the Handpiece connection. Handpiece When complete, provides operator with instructions for disconnecting the Handpiece from the System. September 2021 Solta Medical, Inc. Page 36 of 80 Copyright © 2021 Part # P009240-06...

  • Page 37: Principles Of Operation

    After the System has verified the Handpiece and / or Treatment Tip connection, or corrected the coolant pressure, it will provide an audible chime and automatically transition to the next mode. September 2021 Solta Medical, Inc. Page 37 of 80 Copyright © 2021...

  • Page 38: Ready Mode

    • ADJUST LEVEL mode, if [ADJUST] is pressed in the READY mode. There are two phases in the ACTIVE mode: “Armed...” and “Treating..”. When the System enters the ACTIVE mode it begins in the “Armed...” Phase. September 2021 Solta Medical, Inc. Page 38 of 80 Copyright © 2021 Part # P009240-06...
  • Page 39 Delivering RF step prematurely and begin the Post-Cooling step. Interruption of the treating phase will be indicated by two short beep tones. September 2021 Solta Medical, Inc. Page 39 of 80 Copyright © 2021 Part # P009240-06...

  • Page 40: Delivery Of Rf Energy

    Tip). If the Alert event occurs during an RF treatment, the RF delivery will be terminated, then a Post-Cooling step will be completed prior to generating an “Alert tone” and displaying the event code and event message. September 2021 Solta Medical, Inc. Page 40 of 80 Copyright © 2021 Part # P009240-06...
  • Page 41 The System will neither operate nor will it respond to any switches while the System is in FAULT. The System must be powered OFF and back ON to exit FAULT. A System Reset will then initiate a POST. September 2021 Solta Medical, Inc. Page 41 of 80 Copyright © 2021 Part # P009240-06...

  • Page 42: Clinical Instructions

    Solta recommends that patient feedback regarding their perception of heat or discomfort during the procedure is essential input to guide the operator in determining safe and effective Treatment Levels. September 2021 Solta Medical, Inc. Page 42 of 80 Copyright © 2021 Part # P009240-06...
  • Page 43 Ensure the Treatment Tip is fully seated in the Handpiece prior to use. Note: The Treatment Tip is for single-patient-use only. Do not reuse Treatment Tips. September 2021 Solta Medical, Inc. Page 43 of 80 Copyright © 2021 Part # P009240-06...

  • Page 44: Figure 10.1 Attaching The Treatment Tip

    Insert the Return Pad Cable into the notched end of the Return Pad, as shown in Figure 10.2. Attach the other end of the Return Pad Cable to the RF Generator. Figure 10.2 Return Pad / Return Pad Cable Connection September 2021 Solta Medical, Inc. Page 44 of 80 Copyright © 2021 Part # P009240-06...

  • Page 45: Figure 10.3 Grid Pattern In The Facial Region

    Procedure Guidelines. Figure 10.3 Grid Pattern in the Facial Region September 2021 Solta Medical, Inc. Page 45 of 80 Copyright © 2021 Part # P009240-06...

  • Page 46: Patient Treatment

    10.2.1 Position the Handpiece Assembly as Desired Choose the treatment site. Hold the Handpiece Assembly slightly above the treatment site in a vertical position, perpendicular to the surface being treated. September 2021 Solta Medical, Inc. Page 46 of 80 Copyright © 2021 Part # P009240-06...
  • Page 47 Note: Ensure that the Treatment Tip is fully seated in the Handpiece prior to selecting a higher Treatment Level. Check connectors before selecting a higher treatment level. September 2021 Solta Medical, Inc. Page 47 of 80 Copyright © 2021 Part # P009240-06...
  • Page 48 REPs applied, total number of passes, length of procedure, time between passes, time since last application, etc. September 2021 Solta Medical, Inc. Page 48 of 80 Copyright © 2021 Part # P009240-06...
  • Page 49 Thicker tissue (e.g. frontalis muscle) may require a slight increase in the Treatment Level setting. Thinner tissue (e.g. temple area) typically requires the use of lower Treatment Level settings. September 2021 Solta Medical, Inc. Page 49 of 80 Copyright © 2021...

  • Page 50: Multiple Passes

    (REPS) delivered using the 0.25 cm² Treatment Tip to the upper and lower eyelids combined was 445. The maximum was 1190 and the average was 723. September 2021 Solta Medical, Inc. Page 50 of 80 Copyright © 2021 Part # P009240-06...
  • Page 51 Remove the Return Pad slowly and with great care to avoid skin trauma. Dispose of the coupling fluid, following local governing ordinances and recycling plans. September 2021 Solta Medical, Inc. Page 51 of 80 Copyright © 2021 Part # P009240-06...

  • Page 52: Remove The Handpiece

    10.3.2 Press the release latch located at the top center of the Handpiece connector. Figure 10.4 Handpiece Connector Releases Face Handpiece Connector Release Body Handpiece Connector Release September 2021 Solta Medical, Inc. Page 52 of 80 Copyright © 2021 Part # P009240-06...

  • Page 53: Drain Cryogen From The System

    10.5.1 With the reusable shipping crate lying flat, unlock the four (4) lid latches as shown in Figure 10.6. Figure 10.6 Unlock Reusable Shipping Crate September 2021 Solta Medical, Inc. Page 53 of 80 Copyright © 2021 Part # P009240-06...

  • Page 54: Figure 10.7 Remove Shipping Crate Lid

    10.5.3 Roll the System into the crate by gripping the handle on the rear of the instrument. (See Figure 10.8). Figure 10.8 Roll System Into Shipping Crate September 2021 Solta Medical, Inc. Page 54 of 80 Copyright © 2021 Part # P009240-06...

  • Page 55: Figure 10.9 Close And Lock Shipping Crate

    10.5.4 Use two people to lay the crate flat and replace the lid. Make sure that the ends of the arrows match up (see Figure 10.9). Lock the lid. Figure 10.9 Close and Lock Shipping Crate September 2021 Solta Medical, Inc. Page 55 of 80 Copyright © 2021 Part # P009240-06...

  • Page 56: Troubleshooting

    • System not turned on • Handpiece not connected • Handpiece or Treatment Tip Failure • Damaged RF Generator • Return Pad not connected / poor connection September 2021 Solta Medical, Inc. Page 56 of 80 Copyright © 2021 Part # P009240-06...

  • Page 57: Table 11.1 System Messages

    Problem detected. Press [CONTINUE] to resume operation. E089 COOLANT CANISTER TOO HOT. Turn main power switch off. Wait 2 minutes then turn back on. If event repeats, call for service. September 2021 Solta Medical, Inc. Page 57 of 80 Copyright © 2021 Part # P009240-06...
  • Page 58 Handpiece. E147 Excessive force. Repeat tuning. E148 Insufficient force. Maintain constant force until tone ends. Repeat tuning. E149 Activation switch released too soon. Repeat tuning. September 2021 Solta Medical, Inc. Page 58 of 80 Copyright © 2021 Part # P009240-06...
  • Page 59 E207 Cannot use the attached Treatment Tip. Replace Treatment Tip. E211 Press activation switch BEFORE making contact with skin. If event repeats, call for service. September 2021 Solta Medical, Inc. Page 59 of 80 Copyright © 2021 Part # P009240-06...
  • Page 60 Incompatible Return Pad Cable. Replace with Thermage TP-2 Return Pad Cable. E309 Handpiece nearing expiration. Please call customer service. Press [CONTINUE]. E323 One-half of tip REP count remaining. Press [CONTINUE]. September 2021 Solta Medical, Inc. Page 60 of 80 Copyright © 2021 Part # P009240-06...

  • Page 61: Technical Specifications

    September 2021 Solta Medical, Inc. Page 61 of 80 Copyright © 2021...
  • Page 62 30 cm (12 inches) to any part of the Thermage CPT system, including cables specified by Solta. Otherwise, degradation of the performance of this equipment could result. September 2021 Solta Medical, Inc. Page 62 of 80 Copyright © 2021 Part # P009240-06...

  • Page 63: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Mains power quality should be that of a typical commercial or hospital environment ± 2 kV line(s) to earth ± 2 kV line(s) to earth IEC / EN 61000-4-5 September 2021 Solta Medical, Inc. Page 63 of 80 Copyright © 2021 Part # P009240-06...
  • Page 64 IEC / EN 61000-4-3 80 MHz to 2.7 GHz 80% @ 1 KHz NOTE: There were no test level or compliance deviations to IEC 60601-1-2, 4th edition. September 2021 Solta Medical, Inc. Page 64 of 80 Copyright © 2021 Part # P009240-06...
  • Page 65 As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. September 2021 Solta Medical, Inc. Page 65 of 80 Copyright © 2021...

  • Page 66: Power Output Restrictions

    19.5” (W) x 17” (L) x 49.5” (H) • Weight: 38 kg (84 lb) maximum • Moisture protection rating: IPX0 12.11 Footswitch Specifications • Moisture protection rating: IPX8 September 2021 Solta Medical, Inc. Page 66 of 80 Copyright © 2021 Part # P009240-06...

  • Page 67: Environmental Conditions

    Note: Allow the System to equilibrate to room temperature for a minimum of 4 hours if the System has been stored or transported at temperatures outside of the operating temperature range. September 2021 Solta Medical, Inc. Page 67 of 80 Copyright © 2021 Part # P009240-06...

  • Page 68: Sterilization

    Foot Switch 10 ft / 3 m Patient Return Return Pad 6 ft / 1.8 m Hand Piece Communication Hand Piece 6 ft / 1.8 m September 2021 Solta Medical, Inc. Page 68 of 80 Copyright © 2021 Part # P009240-06...

  • Page 69: Power Output Curves

    Thermage CPT System Technical User’s Manual 13. Power Output Curves Output Power v. Load Half Power Maximum Power Impedance (Ω) Peak Voltage v. Power Setting Power (W) September 2021 Solta Medical, Inc. Page 69 of 80 Copyright © 2021 Part # P009240-06...
  • Page 70 Power Treatment Level 0.5 Power Treatment Level 2.5 Power Treatment Level 5.0 Voltage Treatment Level 0.5 Voltage Treatment Level 2.5 Voltage Treatment Level 5.0 Impedance (Ohms) September 2021 Solta Medical, Inc. Page 70 of 80 Copyright © 2021 Part # P009240-06...
  • Page 71 Power Treatment Level 0.5 Power Treatment Level 5.0 Power Treatment Level 9.5 Voltage Treatment Level 0.5 Voltage Treatment Level 5.0 Voltage Treatment Level 9.5 Impedance (Ohms) September 2021 Solta Medical, Inc. Page 71 of 80 Copyright © 2021 Part # P009240-06...
  • Page 72 Power Treatment Level 0.5 Power Treatment Level 5.0 Power Treatment Level 9.5 Voltage Treatment Level 0.5 Voltage Treatment Level 5.0 Voltage Treatment Level 9.5 Impedance (Ohms) September 2021 Solta Medical, Inc. Page 72 of 80 Copyright © 2021 Part # P009240-06...
  • Page 73 Power Treatment Level 0.5 Power Treatment Level 4.0 Power Treatment Level 7.5 Voltage Treatment Level 0.5 Voltage Treatment Level 4.0 Voltage Treatment Level 7.5 Impedance (Ohms) September 2021 Solta Medical, Inc. Page 73 of 80 Copyright © 2021 Part # P009240-06...
  • Page 74 Power Treatment Level 0.5 Power Treatment Level 5.0 Power Treatment Level 9.5 Voltage Treatment Level 0.5 Voltage Treatment Level 5.0 Voltage Treatment Level 9.5 Impedance (Ohms) September 2021 Solta Medical, Inc. Page 74 of 80 Copyright © 2021 Part # P009240-06...
  • Page 75 Power Treatment Level 0.5 Power Treatment Level 5.0 Power Treatment Level 9.5 Voltage Treatment Level 0.5 Voltage Treatment Level 5.0 Voltage Treatment Level 9.5 Impedance (Ohms) September 2021 Solta Medical, Inc. Page 75 of 80 Copyright © 2021 Part # P009240-06...

  • Page 76: Labeling Symbols

    Additional reference ISO 7000-0624. 5.3.4 Keep dry Additional reference ISO 7000-0626. 5.3.7 Temperature limit Additional reference ISO 7000-0632. 5.3.8 Humidity limitation Additional reference ISO 7000-2620. September 2021 Solta Medical, Inc. Page 76 of 80 Copyright © 2021 Part # P009240-06...
  • Page 77 Additional reference IEC 60417-5021 (2002-10). To identify a foot switch or the connection for a foot 5114 Foot switch switch. Additional reference IEC 60417-5114 (2002-10). September 2021 Solta Medical, Inc. Page 77 of 80 Copyright © 2021 Part # P009240-06...
  • Page 78 ISO 7010-W005 Warning: Non-ionizing To warn of non-ionizing radiation. (2011-06) radiation ISO 7010-W012 Warning: electricity To warn of electricity. (2011-06) September 2021 Solta Medical, Inc. Page 78 of 80 Copyright © 2021 Part # P009240-06...
  • Page 79 When shipped by ground, air, or vessel, small quantities of hazardous IATA Dangerous Goods materials (or dangerous goods)—referred to as “limited quantities”— Regulations are granted relief from certain hazmat shipping requirements. September 2021 Solta Medical, Inc. Page 79 of 80 Copyright © 2021 Part # P009240-06...
  • Page 80 Symbol designates the location of the return pad connector Hand Piece Connector Symbol designates the location of the hand piece connector Contents Listing Symbol Lists the contents of the package September 2021 Solta Medical, Inc. Page 80 of 80 Copyright © 2021 Part # P009240-06...

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