Thermage CPT System Technical Users Manual

Technical Users Manual

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Thermage CPT System Model TG-2B

TECHNICAL USER’S MANUAL

P/N P009240-05

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

Solta Medical, Inc.

Page 1 of 83 Part # P009240-05

MDSS GmbH Schiffgraben 41 30175 Hannover Germany +49 511-6262 8630 www.mdss.com

SOLTA MEDICAL, INC.

11720 North Creek Parkway North, Suite 100 BOTHELL, WA 98011

Telephone: 510-259-5299 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. Refer to page 1 for applicability of this Technical User’s Manual. LIMITED WARRANTY The Seller warrants to the original purchaser of this product that the product substantially conforms to its written specifications current at the date of delivery of such product, and shall perform for a period of one year from such date of delivery substantially in accordance with those specifications. The obligations of the Seller and any affiliate of the Seller under this warranty shall be limited to repair or replacement of a non-conforming product, at the option of the Seller. The above warranty is contingent upon use of the product in accordance with its intended use and pursuant to operating instructions contained in the specifications. This warranty does not cover products that have been modified without the Seller’s prior approval or which have been subject to unusual physical or electrical stress. EXCEPT AS STATED ABOVE, THERE ARE NO OTHER WARRANTIES. THE SELLER EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, WRITTEN OR ORAL, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANT-ABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT.

Solta Medical, Inc.

Page 2 of 83 Part # P009240-05

NOTICES 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. PATENTS Patents that cover the Thermage CPT System can be found at: www.thermage.com/patents

Devices compliant with the European Communities Council Directive 93/42/EEC, Medical Device Directive.

Solta Medical, Inc.

Page 3 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual TABLE OF CONTENTS 1.

INTRODUCTION ... 9 1.1

THERMAGE CPT SYSTEM COMPONENTS ... 9

INDICATED USE ... 10

CONTRAINDICATIONS... 10

WARNINGS AND PRECAUTIONS ... 10 4.1

WARNINGS ... 11

4.2

PRECAUTIONS ... 12

POSSIBLE ADVERSE PATIENT REACTIONS AND MANAGEMENT OPTIONS ... 18 5.1

SURFACE IRREGULARITIES ... 18

5.2

ALTERED SENSATION ... 18

5.3

BURNS, BLISTERS, SCABBING, AND SCARRING ... 18

5.4

LUMPS/NODULES ... 18

5.5

PIGMENT CHANGES (FOCAL) ... 18

5.6

BRUISING ... 18

5.7

ERYTHEMA/BLANCHING ... 18

5.8

SWELLING (EDEMA) ... 19

5.9

MILD/MODERATE PAIN DURING TREATMENT (COMMON AND EXPECTED) ... 19

5.10

URTICARIA (ITCHING)... 19

5.11

HERPES SIMPLEX VIRUS ... 19

THERMAGE CPT SYSTEM ... 20 6.1

PREPARING THE SYSTEM FOR USE ... 20

6.2

SYSTEM AC MAINS POWER CORD ... 20

6.3

SYSTEM CLEANING... 20

6.4

SYSTEM CONTROLS, DISPLAYS, AND INDICATORS ... 22

6.5

THERMAGE HANDPIECE ASSEMBLIES ... 25

6.6

HANDPIECE CLEANING INSTRUCTIONS ... 28

6.7

THERMAGE CPT TREATMENT TIPS ... 28

6.8

HANDPIECE ASSEMBLY CONTROLS ... 28

6.9

INDICATORS FOR THE FACE HANDPIECE ... 31

THERMAGE ACCESSORIES... 31 7.1

FOOTSWITCH (OPTIONAL) ... 31 Solta Medical, Inc.

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Thermage CPT System Technical User’s Manual 7.2

RETURN PAD ... 31

7.3

CRYOGEN CANISTER ... 31

THERMAGE CPT SYSTEM SETUP INSTRUCTIONS ... 32 8.1

INSTALLING SYSTEM ACCESSORIES ... 32

8.2

SYSTEM CONFIGURATION ... 36

PRINCIPLES OF OPERATION ... 38 9.1

SYSTEM MODES ... 38

9.2

DELIVERY OF RF ENERGY ... 41

9.3

SHUTDOWN CONDITIONS ... 41

9.4

ABNORMAL SYSTEM EVENTS ... 41

10. CLINICAL INSTRUCTIONS... 43 10.1

PRE-TREATMENT PREPARATION ... 43

10.2

PATIENT TREATMENT ... 47

10.3

REMOVE THE HANDPIECE ... 53

10.4

DRAIN CRYOGEN FROM THE SYSTEM ... 54

10.5

PACK THE SYSTEM ... 54

11. TROUBLESHOOTING ... 57 11.1

SYSTEM PROBLEMS ... 57

12. TECHNICAL SPECIFICATIONS ... 62 12.1

AC INPUT RATING ... 62

12.2

RF OUTPUT ... 62

12.3

ELECTRICAL SAFETY ... 62

12.4

ELECTROMAGNETIC COMPATIBILITY ... 62

12.5

POWER OUTPUT RESTRICTIONS ... 68

12.6

FUSES ... 68

12.7

SETTINGS ... 68

12.8

MEASUREMENT ACCURACY1 ... 68

12.9

ENCLOSURE MATERIAL... 68

12.10

MECHANICAL SPECIFICATIONS-SYSTEM ... 68

12.11

FOOTSWITCH SPECIFICATIONS... 68

12.12

ENVIRONMENTAL CONDITIONS ... 69

12.13

STERILIZATION ... 70

12.14

MAINTENANCE... 70

12.15

DISPOSAL ... 70

Solta Medical, Inc.

Page 5 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual 12.16

TECHNICAL SPECIFICATIONS ... 70

13. POWER OUTPUT CURVES ... 71 14. LABELING SYMBOLS ... 78

Solta Medical, Inc.

Page 6 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual LIST OF FIGURES Figure

Page #

Figure 6.1

Thermage CPT System

Figure 6.2

Thermage CPT System Front Panel

Figure 6.3

Front Panel Display

Figure 6.4

Thermage Face Handpiece

Figure 6.5

Thermage Body Handpiece

Figure 6.6

Handpiece Control Buttons

Figure 6.7

Face Handpiece: Indicators

Figure 8.1

SD Card Installation

Figure 8.2

Power Switch-Power ON

Figure 8.3

Installing the Cryogen Canister

Figure 8.4

System Front Panel

Figure 8.5

Return Pad Cable, Handpiece Connected

Figure 8.6

Footswitch Connection

Figure 8.7

Generator SYSTEM TOOLS Screen

Figure 10.1

Attaching the Treatment Tip

Figure 10.2

Return Pad/Return Pad Cable Connection

Figure 10.3

Grid Pattern in the Facial Region

Figure 10.4

Handpiece Connector Releases

Figure 10.5

Vent Valve Release

Figure 10.6

Unlock Reusable Shipping Crate

Figure 10.7

Remove Shipping Crate Lid

Figure 10.8

Roll System Into Shipping Crate

Figure 10.9

Close and Lock Shipping Crate

Solta Medical, Inc.

Page 7 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual LIST OF TABLES Table

Page #

Table 1.1

System Components and Accessories

Table 6.1

System Buttons

Table 6.2

Front Panel Display Indicators

Table 6.3

Front Panel System Indicators

Table 6.4

Handpiece Control Buttons

Table 8.1

How to Adjust System Tools Screen - Menu Options

Table 11.1

System Messages

Table 14.1

Labeling Symbols

Solta Medical, Inc.

Page 8 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual

1. Introduction 1.1

Thermage CPT System Components

The Thermage CPT System described in this Technical User’s Manual consists of the following: Table 1.1 System Components and Accessories Description

Model #

Thermage CPT Generator with Cooling System

TG-2B

Thermage CPT Standard Handpiece with Vibration

TH-4

Thermage CPT 16.0 Handpiece

TH-3

Thermage Treatment Tips (0.25 cm2, 3.0 cm2 and 16.0 cm2)

TTNS series

Electronic Footswitch (optional)

TW-1

Return Pad

TR-2

Return Pad Cable

TP-2

Cryogen Canister

TC-1-4 / TC-2-4

Coupling Fluid

TF Series

Skin Marking Paper

TK Series



Software Version: Please verify software version on system home screen under the Thermage logo.



The Thermage CPT System (‘System’) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece (‘Body Handpiece’), Standard Handpiece with Vibration (‘Face Handpiece’), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips. The components and accessories listed in Table 1.1 will also be referred to in this User’s Manual as the ‘System’. The Thermage CPT RF Generator will also be referred to in this User’s Manual as the ‘Generator’. The Thermage CPT Body Handpiece or Face Handpiece with Vibration with attached Treatment Tips will also be referred to in this User’s Manual as the ‘Handpieces’ and/or ‘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.

 

 October 2018

Solta Medical, Inc.

Page 9 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual This Technical User’s Manual provides a description of the System, its controls and displays, and a sequence for its proper operation. This manual also supplies other information of importance to the operator (user) and is intended as a user’s manual only. Do not operate the Thermage CPT System before thoroughly reading and understanding this manual.

2. Indicated Use The radiofrequency (RF) energy delivery components of the Thermage CPT System and Accessories are indicated for use in:   

Dermatologic and general surgical procedures for electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids.

The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT System and Accessories are indicated for use in:       

Dermatologic and general surgical procedures for electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and rhytids; Non-invasive treatment of wrinkles and rhytids; Temporary improvement in the appearance of cellulite; Relief of minor muscle aches and pains; Relief of muscle spasms; 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 pacemaker, an Automatic Implantable Cardioverter/Defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency (RF) field or current.

4. Warnings and Precautions The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. It is important that all warnings, precautions, and the supplied operating instructions be read, understood, and followed before and during use. October 2018 Copyright © 2018

Solta Medical, Inc.

Page 10 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual 4.1

Warnings

4.1.1 The Thermage RF system has been studied in US clinical trials for the treatment of wrinkles and rhytids. Use of the System for indications other than those expressed in this manual are considered “off-label”. 4.1.2 The user must be aware that failure of the System could result in an unintended increase in output power. 4.1.3 Remove all of the anesthetic material and/or other substances (cosmetics, lotions, etc.) from the surface of the skin at the treatment site. During the treatment process there must be no material, other than Thermage Coupling Fluid between the surface of the Treatment Tip and the patient’s skin. 4.1.4 Thoroughly remove beard stubble prior to treatment. 4.1.5 Treatment in areas containing superficial and/or other facial nerves may be more sensitive and susceptible to irritation. The operator should pay special attention to patient heat feedback and consider reducing the Generator Treatment Level setting when treating these areas. 4.1.6 Caution should be used when treating skin directly over metal dental work. In particular, when treating over metal dental work of large surface areas (such as crowns, braces, implants, etc.) consideration should be given to inserting dry absorbent cotton roll(s) between the dental work and the inner cheek area to prevent radiofrequency heating of the metal materials. Such heating may result in burns to the skin, dental pain, and/or damage to the dental work. 4.1.7 Do not use the System near critical life-support equipment. Radiofrequency electromagnetic emissions can interfere with the operation of electronic equipment. 4.1.8 Caution should be used when selecting treatment levels. The risks of adverse outcomes may be associated with elevated treatment levels. 4.1.9 Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 4.1.10 The use of accessories, transducers and cables other than those specified could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Thermage CPT system and result in improper operation. 4.1.11 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 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.

Solta Medical, Inc.

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Thermage CPT System Technical User’s Manual 4.2

Precautions General

4.2.1 Solta has not studied the use of the Thermage CPT system in humans over dermal fillers. 4.2.2 The use of the Thermage CPT System on the following patient populations is unstudied and unknown:      

Pregnant and breast-feeding Diabetic Auto-immune disease (e.g. lupus) Herpes simplex Children Epilepsy

4.2.3 An Eyes by ThermageTM treatment requires use of PLASTIC ocular shields. DO NOT use metal shields. Follow standard precautions for the placement and use of the eye shields. 4.2.4 The Thermage CPT system does not allow for vibration during an Eyes by ThermageTM treatment. The System disables vibration when the 0.25 cm2 treatment tip is attached to the Standard Handpiece. Do not attempt to use the 3.0 cm2 treatment tips around the eye or on the eye lid with vibration. Vibration may cause displacement of the ocular shields; resulting in increased risk of corneal abrasions or ocular damage. 4.2.5 Allow the System to equilibrate to room temperature for a minimum of four (4) hours if the System has been stored at temperatures outside the operational temperature range-below 15° C (59° F) or above 25° C (77° F). 4.2.6 Use only Solta-supplied Accessory Cables with the System. 4.2.7 Do not use this System in the presence of flammable anesthetics, other flammable gases, near flammable fluids (e.g. skin preparation agents and tinctures), flammable objects, or with oxidizing agents. Observe appropriate fire precautions at all times. 4.2.8 Allow flammable agents used for cleaning, disinfecting, or as solvents to evaporate completely before use of the equipment or application of RF energy. 4.2.9 Do not use this device in oxygen-enriched atmospheres or in the presence of nitrous oxide (N2O). 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).

Solta Medical, Inc.

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Thermage CPT System Technical User’s Manual 4.2.11 The activation tone and lights on the Thermage CPT System are important safety features. Do not obstruct the visual indicators or disable the audible tone. 4.2.12 During treatment, precautions must be taken so the patient cannot come into contact with earthed metal parts or parts with appreciable capacitance to earth (e.g. operating table supports, etc.). The use of antistatic sheeting is recommended for this purpose. 4.2.13 The System operator should avoid direct contact with the patient while the RF energy is being applied. Use of insulating gloves is recommended to prevent inadvertent electrical shock. 4.2.14 Use only Solta-supplied components and accessories. 4.2.15 Do not wrap instrument cables around metal objects as doing so may induce hazardous currents. 4.2.16 Skin to skin contact (e.g. between a patient’s arms and body) should be avoided. The insertion of dry gauze between adjacent body parts is advised. 4.2.17 Place all monitoring electrodes, such as for an electrocardiogram (ECG, EKG), as far as possible from the treatment area when the System and physiological monitoring equipment are used simultaneously on the patient. The use of monitoring systems incorporating high frequency current-limiting devices is recommended. 4.2.18 Interference produced by the System may adversely influence the operation of other electronic equipment. 4.2.19 Verify that the reusable cables and Handpieces have been cleaned prior to each use. 4.2.20 After use, Thermage Treatment Tips, Skin Marking Paper, and Return Pads should be treated as biohazardous waste and disposed of in accordance with applicable laws and regulations. 4.2.21 Keep Treatment Tips evenly in contact with treatment area skin throughout the treatment application. The Thermage CPT System senses contact with the skin and deactivates the RF energy if contact is lost. When vibration is on, the System senses contact with skin in the same way as when vibration is off. RF Generator 4.2.22 The AC mains power cord of the RF Generator must be connected to a properly grounded receptacle. 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. October 2018 Copyright © 2018

Solta Medical, Inc.

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Thermage CPT System Technical User’s Manual Skin Marking Grid Paper 4.2.24 Use in a well-ventilated area. 4.2.25 For use only with specified Thermage Treatment Tip. 4.2.26 Avoid eye contact with alcohol. If irritation occurs, flush eye(s) with water for 5 minutes. 4.2.27 Flammable agents used for cleaning or disinfecting or as solvents should be allowed to evaporate before application of RF Energy. 4.2.28 For use only with Thermage Systems. 4.2.29 Single-patient-use only. Do not reuse skin marking grids once they have been applied to skin. 4.2.30 Do not use if the paper is damaged. Return Pad 4.2.31 The Return Pad is the RF Generator’s Neutral Electrode. Therefore, it is an integral part of the Thermage RF energy delivery System. The proper use and placement of the Return Pad are key elements in the safe and effective utilization of this device. The following precautions are necessary to prevent burns at the Return Pad (Neutral Electrode) site. 4.2.32 The Return Pad is single-patient use only. Reusing the Return Pad may result in poor contact quality, patient burns, and/or poor system performance. 4.2.33 The Return Pad was designed to be used with Thermage Systems only. Use only a Solta-supplied Return Pads. 4.2.34 Do not use a Return Pad on patients with known sensitivity to acrylates. 4.2.35 Do not cut or modify the Return Pad or its connector in any way. 4.2.36 Periodically inspect the Return Pad Cable for any signs of damage or wear that may have exposed wiring or produced other defects and each that the Return Pad connects are intact. 4.2.37 To properly place a Return Pad before the treatment: 4.2.37.1 Select a well vascularized area that is free of hair and tattoos, has minimal curvature, and is appropriately distanced from the treatment area. Avoid placement over scars, breached or inflamed skin, fatty tissue, bony prominences, metal prosthesis, and where fluids pool. Do not place the 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.

Solta Medical, Inc.

Page 14 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual 4.2.37.3 Inspect the cable and connector for any signs of damage or wear that may have exposed wiring or other defects. 4.2.37.4 Inspect the Return Pad package. Do not use if the package is opened, damaged, or expired. 4.2.37.5 Peel off the blue plastic backing. Place the Return Pad with its entire area adhering to the patient’s skin with the tab pointing away from the treatment area. Avoid touching the patient contacting region of the Return Pad. The entire area of the Return Pad must be in full contact with the patient's body. Failure to achieve good skin contact by the entire adhesive surface may result in a burn or poor system performance. 4.2.37.6 To prevent patient burns at the Return Pad application site due to improper adhesion, verify that the Return Pad cable is not pulling on the Return Pad with more force than the cable's own weight. 4.2.37.7 Insert the Return Pad tab into the connector. Close the clamp until a click is heard. Tug lightly to verify the connection is secure. When placed correctly, the blue tab at the neck of the Return Pad should be only partially visible. 4.2.37.8 When positioning the patient for treatment, check and verify that no object is placed under the connector in a manner such that the Return Pad tab is lifted from the skin. 4.2.38 During the treatment: 4.2.38.1 Attention should be given to the Return Pad for signs of heating. The patient should feel no sensation of heat at the Return Pad site during tuning or treatment. If the patient reports feeling heat or electrical stimulus at the site, immediately discontinue RF delivery and check the Return Pad’s placement and all cable connections. Do not continue treatments until this condition is corrected. (Refer to Section 4.2 – Precautions). 4.2.38.2 The Return Pad must be kept dry. Avoid contaminating the Return Pad connector with Coupling Fluid or other types of creams or lotions. A patient’s excessive sweating may warrant replacing the Return Pad during the treatment. 4.2.38.3 Prior to increasing treatment level settings, check that the Return Pad has full contact with the patient's skin. Check cables and connectors, and inspect active accessories as well. 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.

Solta Medical, Inc.

Page 15 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual 4.2.38.5 Do not relocate the Return Pad after initial application. Use a new pad if relocation is needed. 4.2.38.6 Periodically check that the Return Pad Cable for any signs of damage or wear that may have exposed wiring or produced other defects and check that the Return Pad cable connections are intact. 4.2.38.7 Poor Return Pad contact may lead to low RF delivery and/or a system error condition. 4.2.39 At the end of the treatment: 4.2.39.1 Disconnect the tab from the connector. Gently remove the Return Pad and discard it. Do not reuse it, as the Return Pad is designed for single patient use. Reuse of return pads may lead to reduced efficacy or increased sensation of heating. See section 4.2.37.1. 4.2.39.2 Inspect the Return Pad site on the patient to ascertain whether any skin compromises occurred during the treatment. Coupling Fluid 4.2.40 Use coupling fluid with only Thermage Systems. 4.2.41 Single-patient-use only. Do not reuse. Reuse of coupling fluid may result in poor system performance. 4.2.42 Do not use if the bottle is opened or damage. Cryogen and Cryogen Canister 4.2.43 Avoid breathing high concentrations of cryogen vapor. Deliberate inhalation of the vapor will cause asphyxiation. Death can occur without warning. 4.2.44 FIRST AID: If overcome by vapors, move to fresh air. For skin or eye contact, thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical attention. 4.2.45 Direct contact with liquid cryogen may cause tissue to freeze. Avoid contact with eyes and skin when handling cryogen. Wear protective goggles and gloves when handling open Cryogen Canisters. 4.2.46 Do not store the canister near heat or open flame. 4.2.47 Do not puncture, incinerate, or expose the canister to temperatures above 49° C (120° F). 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). October 2018 Copyright © 2018

Solta Medical, Inc.

Page 16 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual 4.2.50 Keep canisters out of the reach of children. 4.2.51 Remove all cryogen from the System prior to transportation. A ‘flushing’ sound may be heard during coolant release. Parts of the System may be very cold-use caution and avoid contact with these parts. See Section 11.2. Warning Non-Sterile Treatment Tip Cleaning - User 4.2.52 Non-Sterile Treatment Tips are provided clean by the manufacturer; however, it is the responsibility of the user to clean the tip before treatment use. The tip should be wiped with 70% alcohol (preps) and inspected for debris and other contamination. 4.2.53 Treatment Tips are for single patient use only. Do not reuse. Multiple patient use creates a risk of cross contamination of microorganisms from one patient to another. 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.

Solta Medical, Inc.

Page 17 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual

5. Possible Adverse Patient Reactions and Management Options 5.1

Surface Irregularities

Surface Irregularities are variously described as (localized) “small dents in the surface of the skin,” “rippling,” “ridging,” “waffle patterns”, or “fat loss” (covering a larger surface area). Frequently, surface irregularities are not evident immediately post-treatment, but show up later (1 or more months post-treatment). In most cases Solta recommends that surface irregularities be monitored for a period of six months post onset. Tissue fillers may be considered as a treatment option if the condition does not resolve on its own. 5.2

Altered Sensation

Altered sensation has been described as “numbness”, “tingling” or “temporary paralysis”. Altered sensation typically resolves in a short period of time, but infrequently may persist up to several weeks. This adverse event is rare and, as is the case with an invasive face-lift procedure, resolves over time without intervention. 5.3

Burns, Blisters, Scabbing, and Scarring

The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation. There is a small chance of scar formation. Application of topical steroidal or antibiotic preparations may be of benefit. In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device. 5.4

Lumps/Nodules

Reports of sub-cutaneous “Lumps” or “Nodules” occurring primarily in the neck area may occur. It typically self-resolves within 1 or 2 weeks without adverse sequelae. 5.5

Pigment Changes (Focal)

Cases of hyperpigmentation usually resolve over the course of time (within several months). 5.6

Bruising

Bruising may occur in rare cases and typically dissipates within several days. Bruising may be more typically associated with the use of some injected anesthetic agents (e.g. nerve blocks). 5.7

Erythema/Blanching

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.

Solta Medical, Inc.

Page 18 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual 5.8

Swelling (Edema)

Swelling may occur and typically resolves within 5 days, but can persist up to several weeks. Application of cold compresses or gels immediately following the treatment may help to reduce the occurrence of this event. 5.9

Mild/Moderate Pain During Treatment (Common and Expected)

Typically, the discomfort is temporary during the procedure and localized within the treatment area. Rarely, patients have reported transient aching in the treatment area lasting up to several months. 5.10

Urticaria (Itching)

There have been occasional reports of a mild to moderate, transient itching sensation in the treatment area. Application of over-the-counter topical preparations may be helpful in relieving the symptoms. 5.11

Herpes Simplex Virus

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.

Solta Medical, Inc.

Page 19 of 83 Part # P009240-05

Thermage CPT System Technical User’s Manual

6. Thermage CPT System Inspect the System for any signs of physical damage to the front panel, chassis or cover, and Handpieces (refer to Figure 6.1 - Thermage CPT System). Inspect the Handpieces and return pad cables for possible damage to their insulation. 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.

Recommended ESD Training and Precautionary Procedures Prior to assembly, install or interconnection of the Thermage CPT System, it is recommended that any staff (i.e., biomedical engineers and health care staff) that could touch connectors identified with the ESD warning symbol undergo ESD training. At minimum, ESD training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if they are touched by an operator who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge, and how and why to discharge one’s body to earth or to the frame of the equipment or system, or bond oneself by means of a wrist strap to the equipment or system or to earth prior to making a connection. Finally, staff must be made aware that accessible pins of connectors identified with the ESD warning symbol should not be touched with the fingers or with a handheld tool unless proper precautionary procedures have been followed. 6.1

Preparing the System for Use

Provide at least 10 inches (25 cm) space around the back, sides and top of the System for convective cooling. Under continuous use for extended periods of time, it is normal for the top and rear panels to become warm. 6.2

System AC Mains Power Cord

The System is shipped with an approved, hospital-grade AC mains power cord. Do not use extension cords or three-to-two-prong adapters. The AC mains power cord assembly should be periodically checked for damaged insulation or connectors. 6.3

System Cleaning

Clean the System only when it is unplugged from the mains power source. A 70% isopropyl alcohol solution or damp cloth may be used to clean the System cover, front panel, and AC mains power cable. Allow isopropyl alcohol solution to evaporate before using the System. Do not allow fluids to enter the chassis. Do not spray or pour liquids directly on the unit.

Solta Medical, Inc.

Page 20 of 83 Part # P009240-05

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