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R A D I O F R E Q U E N C Y S Y S T E M O P E R A T O R ’ S M A N U A L AAAP11090601...
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No part of this manual may be reproduced or copied in any form by any means - graphic, electronic or mechanical, including photocopying, typing, or information retrieval systems - without written permission of Alma Lasers. System specifications and the information contained in this document are subject to change without notice.
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Table of Contents Scope of This Manual This operator's manual incorporates the following chapters: Chapter 1 System Overview Contains a general introduction to the Accent XL system. Contains explanations and directions concerning safety Chapter 2 Safety measures for operating the system, international standard compliance, classifications and regulatory labels.
Table of Contents Table of Contents CHAPTER 1 System Overview Page 1.1. Use of this Manual.....................1-2 1.2. Physician Responsibility ...................1-2 1.3. Maintenance ......................1-3 1.4. Modification of the System ................1-3 1.5. Resale Inspection....................1-3 1.6. Abbreviations and Acronyms ................1-3 CHAPTER 2 Safety Page 2.1.
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Table of Contents 2.5.2. Packaging Label................2-11 CHAPTER 3 Installation Page 3.1. Introduction ....................... 3-2 3.2. Equipment List ....................3-2 3.3. Facility Requirements ..................3-3 3.3.1. Space and Positioning ..............3-3 3.3.2. Electrical Requirements ..............3-4 3.3.3. Environmental Requirements ............3-4 3.4. Connecting the Footswitch................3-5 3.5.
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Table of Contents 4.4.3. Physical ....................4-9 4.4.4. System Requirements ..............4-10 4.4.5. Delivery System ................4-10 4.4.6. Classifications ................4-10 CHAPTER 5 Controls and Indicators Page 5.1. Introduction .......................5-2 5.2. Control Panel Components................5-2 5.2.1. Keyswitch..................5-3 5.2.2. Emergency Shut-Off Knob ..............5-4 5.2.3. RF Emission Indicators ..............5-4 5.2.4.
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Table of Contents 6.13. System Shut-Down..................6-10 6.14. Error Detection....................6-11 CHAPTER 7 Maintenance Page 7.1. Introduction ....................... 7-2 7.2. Periodic Service....................7-2 7.3. Service Information................... 7-3 7.4. Routine and Preventive Maintenance..............7-4 7.4.1. Cleaning and Disinfecting the System ..........7-4 7.4.2.
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Table of Contents A.8.1. General .....................A-4 A.8.2. Counseling ..................A-4 A.9. Photography...................... A-5 A.10. Treatment......................A-5 A.10.1. Handpieces: Practical Considerations of Operation and Technique ..................A-6 A.10.2. Facial Treatment Areas ..............A-7 A.10.3. Treatment Objectives ................A-8 A.10.4. End-Points ..................A-8 A.10.5. Handpiece Operation................A-8 A.11. Treatment Protocol ................... A-8 A.12.
Table of Contents Figure 3-12: Closing the Control Panel (with the Handpieces Connected) .......... 3-10 Figure 3-13: Dummy Handpiece Connector ..................3-11 Figure 3-14: System Handle........................3-12 Figure 4-1: The Accent XL System ......................4-2 Figure 4-2: Accent XL Handpieces......................4-4 Figure 4-3: Handpiece Components......................
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CHAPTER 1 System Overview Chapter Contents: Section Title Page 1.1. Use of this Manual................1-2 1.2. Physician Responsibility..............1-2 1.3. Maintenance..................1-3 1.4. Modification of the System ............... 1-3 1.5. Resale Inspection ................1-3 1.6. Abbreviations and Acronyms ............1-3 ™...
The information provided in this manual is not intended to replace the professional training on the clinical use of the system. Please contact your Alma Lasers representative for current information on available training. For clinical information, refer to the Clinical Guide appendices that include set up guidelines for each application.
The Accent XL is a precision, technical medical device. If any Alma Lasers device is resold by anyone other than an authorized sales representative, Alma Lasers offers a resale inspection by an Alma Lasers technician to assure that the device is working in accordance with manufacturer’s specifications. Using the device after it has been resold and before it has been inspected is a misuse of the device, which may result in injuries and voids all warranties, expressed and implied.
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System Overview International Electrotechnical Commission Impedance matching network Infrared Joule(s) Kilogram(s) Pound(s) Liquid crystal display Light emitting diode Meter(s) Millimeter(s) Mega Pulse width modulation Radiofrequency Second(s) Thermoelectric cooling Volt(s) Volt(s) alternating current Volt(s) direct current Watt(s) ™ Accent XL Operator's Manual...
Safety 2.1. Introduction This chapter describes general safety issues regarding the use of the Accent XL system, with special emphasis on radiofrequency and electrical safety. Warning Hazardous voltages are energized when the emergency shut-off knob is engaged. Note Federal law (USA) restricts this device to only be sold to, or on the order of a physician or any practitioner licensed by the law of the state in which he or she practices or intends to use or order the use of the device.
Safety • If an error occurs, the system displays a warning message and, if necessary, the software shuts down the system. 2.2.2. Keyswitch • The system can be turned on only when the key is inserted in the keyswitch. • When not in operation, the key should be removed to prevent unauthorized use of the system.
Safety 2.2.7. RF Emission Indicators The red light indicator on the control panel and the blue LED indicator on the handpieces are illuminated both prior to and during radiofrequency emission: • mode, the indicators blink to indicate that radiofrequency Ready emission will occur when the handpiece trigger or the footswitch is pressed.
2.3.2. Cautions • Only Alma Lasers authorized personnel may service the Accent XL system. This includes making internal adjustments to the power supply, cooling system, handpieces, etc. • Maintenance performed by the operator must only take place when the system is shut down and disconnected from the electrical power source.
The Accent XL system produces very high voltages in various components. Some components may retain a charge after the power supply has been turned off, so no part of the exterior housing should be removed, except by Alma Lasers authorized personnel.
• Plug the system into a wall socket on a different circuit than the other equipment • Consult with Alma Lasers technical service personal for assistance • Avoid placing the handpiece cable in contact with the patient ™ Accent XL...
Safety 2.4. Equipment Classification and Compliance The Accent XL system complies with the following standards: • IEC 60601-1-2: Medical electrical equipment: Part 1-2; Collateral Standard: Electromagnetic compatibility - Requirements and tests (2001) • EN 61000: Electromagnetic compatibility (EMC) • EN 61000-3-2: Section 2; Limits for harmonic current emissions (equipment input current up to and including 16A per phase) (2000) •...
Safety • Proper labeling In accordance with the regulations, a recommended routine inspection and maintenance schedule is provided in the Maintenance chapter of this manual (see Chapter 8). 2.5. Device Labels 2.5.1. System Labels The following labels are adhered to the Warning Certification Identification...
Safety • Electrical Requi rement and Hazard Label, located next to the power cable connection port 115V Figure 2-2: Electrical Requirement and Hazard Label ther informative labels placed around the system: • label located on the service Footswitch FOOTSWITCH panel to identify the footswitch connectio n port •...
When the Accent XL system is purchased, complete on-site installation, including initial system testing and calibration, is included. System transportation and installation is carried out by Alma Lasers authorized technical personnel, who will do the following: •...
Installation 3.3. Facility Requirements Before unpacking the system, ensure that the site meets the requirements described in the following sections. 3.3.1. Space and Positioning Space should be allocated with adequate ventilation and free airflow. The working area for the system should be prepared according to the system dimensions presented in Figure 3-1.
Installation 3.3.2. Electrical Requirements The system is factory pre-wired for the local line voltage. Accordingly, the system will require a separate line supply of: • 110-120 VAC ±10%, 5A, 50/60 Hz, single phase The input power line should be free of transients, voltage and current spikes, sags and surges.
Installation 3.4. Connecting the Footswitch The footswitch supplied with the system is pneumatically operated for increased safety. To connect the footswitch, connect the footswitch's black tube to the connection port on the system's service panel (shown by the arrow in Figure 3-2). Note Connecting the footswitch is necessary only if you prefer to use the footswitch for RF emission.
Installation 3.6. Adjusting the Handpiece Support Arms The Accent XL system has two handpiece support arms with adjustable heights (see Figure 3-3). Support Arms Support Arm Locks Figure 3-3: Handpiece Support Arms and Locks To adjust the height of a handpiece support arm: Release the handpiece support arm lock, as shown in Figure 3-4.
Installation Move the handpiece support arm up/down to the desired height (see Figure 3-5). Figure 3-5: Adjusting the Height of the Handpiece Support Arm Fasten the lock by reversing the action shown in Figure 3-4. Note It is recommended to set both handpiece support arms to the same height.
Installation 3.7. Connecting the Handpiece On top of each handpiece support arm, there is a handpiece holder, used for securing a handpiece (see Figure 3-6). Handpiece Holders Figure 3-6: Handpieces on the Handpiece Holders To connect a handpiece: Place the handpiece in the handpiece holder (see Figure 3-6).
Installation Insert the handpiece connector into the port (see Figure 3-8). Handpiece Connection Handpiece Receptacles Connector Figure 3-8: Inserting the Handpiece into the Port Note Connect the handpiece to the port that is on the same side as its support arm. Engage the hook of the handpiece connector locking handle onto the fastener pin of the port, as shown in Figure 3-9.
Installation Gently push down on the locking handle to lock the handpiece connector in place (see Figure 3-10). Figure 3-10: Pushing Down the Locking Handle Repeat the above procedure to connect the second handpiece. Figure 3-11: Connecting the Second Handpiece Close the control panel (see Figure 3-12).
Installation To disconnect a handpiece: Place the handpiece in the handpiece holder (see Figure 3-6). 10. Verify that the support arm is raised high enough to enable you to open the control panel without dislodging the handpiece from its holder. 11.
To move the system, use only the handle on top of the system (see Figure 3-14). Do not pull the system by any other part. Handle Figure 3-14: System Handle To transport the system to another facility, consult your Alma Lasers service representative. Caution •...
CHAPTER 4 System Description Chapter Contents: Section Title Page 4.1. Introduction ..................4-2 4.2. System Components and Controls............. 4-2 4.3. System Features ................. 4-6 4.4. System Specifications................ 4-8 ™ Accent XL Operator's Manual...
System Description 4.1. Introduction This chapter provides a detailed description of the Accent XL system. The description covers the system's main components, controls and functional sub- systems, the unipolar & bipolar handpieces and system & handpiece specifications. The Accent XL is a radiofrequency non-invasive multi-application system. A complete discussion of the handpieces, their uses and technical specifications may be found in Section 4.2.4 of this chapter.
System Description 4.2.1. System Console The system console (see Figure 4-1) contains all internal components and subsystems required for operation and control of the Accent XL system. They include: • RF generator • Water cooling system • Micro-controller board 4.2.2. The Control Panel The Accent XL's control incorporates the following features: •...
System Description 4.2.4. Handpieces The handpieces are used to deliver radiofrequency energy to the treatment site. The following handpiece types are used with the Accent XL system (see Figure 4-2): • Bipolar radiofrequency • Unipolar radiofrequency Unipolar Handpiece Bipolar Handpiece Figure 4-2: Accent XL Handpieces ™...
System Description Each handpiece consists of (see Figure 4-3): • Handle – used for holding the handpiece • Trigger – activates the radiofrequency energy emission when pressed in Ready mode • Applicator tip – establishes radiofrequency energy transmission contact with the patient's skin. •...
System Description 4.2.5. System Software The Accent XL is a computerized system with embedded software that controls its operation. The software controls the operating parameters, runs routine tests to ensure proper and safe operation, and coordinates its various sub-systems. The software also runs the graphical user interface, which enables user-friendly control of the system operation.
System Description 4.3.2. Save Option In order to save time on setting the operating parameters, the system allows the operator to save two sets of operating parameters, one for each handpiece – bipolar and unipolar. The parameters are saved in the memory chip located in the handpiece connector. The saved parameters become the default settings for each handpiece.
System Description 4.3.4. Technician Mode The technician mode is designed for diagnostic and service purposes. The technician mode is password-protected and its access is restricted to Alma Lasers authorized service personnel only. Warning • Only Alma Lasers authorized service personnel are qualified to access the technician mode.
System Description Duty Cycle • 5 – 60% Pulse Rise/Fall Time • (duty cycle 5-100%): <1.5 µsec 4.4.2. Operation and Control System Control • Fully computerized, micro-controller based Graphic User Interface • LCD touch-screen RF Emission Indicators • Visual, illuminating red indicator on the control panel: OFF when no RF emission occurs Blinking during Ready mode Illuminating continuously during RF emission...
Controls and Indicators 5.1. Introduction This chapter describes in detail the controls, indicators and connections of the Accent XL system. They include: • Control panel components • Service panel components • Handpiece connection ports • Emission control devices 5.2. Control Panel Components The Control panel is located at the top of the system's front side, as shown in Figure 5-1: Control...
Controls and Indicators Figure 5-2 exhibits the controls and indicators on the control panel: Emergency RF Emission Shut-Off Knob Indicator Keyswitch RUN LED Touch-Screen LCD Panel Figure 5-2: Control Panel Components 5.2.1. Keyswitch The keyswitch is located at the top of the control panel (see Figure 5-2). The keyswitch is used to turn the system on and off: •...
Controls and Indicators 5.2.2. Emergency Shut-Off Knob The emergency shut-off knob is located at the top of the control panel (see Figure 5-2). In case of an emergency, pressing the emergency shut-off knob shuts down the Accent XL immediately by cutting off the electrical supply to the system. To resume the system operation, turn the emergency shut-off knob clockwise, to release it (the knob pops out), and then restart the system.
Controls and Indicators 5.2.5. Touch-Screen Panel The transparent touch-screen panel overlays the LCD graphic display (see Figure 5-2). The touch-screen panel provides the primary means of communication between the operator and the system. The computer-controlled graphic user interface keeps the operator informed of the system status and operating parameters at all times.
Controls and Indicators 5.3. Service Panel Components The service panel (see Figure 5-3) incorporates the following system controls and connections: • Main switch • Power cable connection port • Fuse housing • Footswitch air tube connection port • Water fill, drain and vent ports •...
Controls and Indicators 5.4. Handpiece Trigger Radiofrequency emission is controlled by the handpiece trigger (see Figure 5-4). Radiofrequency emission starts by pressing the trigger only when the system is in mode. Ready Note • Only the handpiece that is currently selected can be activated in Ready mode.
Controls and Indicators 5.5. Footswitch The pneumatic footswitch (see Figure 5-5), supplied with the Accent XL system provides an additional means for starting radiofrequency emission. Radiofrequency emission starts by pressing the footswitch only when the system is Ready mode. The footswitch's pneumatic tube is connected to its connector on the service panel (see Figure 5-3).
Controls and Indicators 5.6. Handpiece Connection Ports The two handpiece connection ports are located underneath the control panel (see Figure 5-6). The handpiece connection ports are the ports that connect the handpieces to the system and lock the handpiece connectors in place. For detailed instructions on connecting the handpieces, refer to Chapter 3 –...
CHAPTER 6 Operating Instructions Chapter Contents: Section Title Page 6.1. Introduction ..................6-2 6.2. Prepare the System for Operation............6-2 6.3. Operating the System................. 6-2 6.4. Turn on the System................6-3 6.5. Select the Handpiece................6-5 6.6. Graphic User Interface............... 6-5 6.7.
This system may only be operated by a licensed practitioner. • Improper use or adjustment of this system may invalidate the Accent XL service warranty agreement. Please contact your authorized Alma Lasers distributor before attempting to use the system in any manner other than those specified in this manual.
Operating Instructions 6.4. Turn on the System To turn on the Accent XL system: Verify that the emergency shut-off knob is not pressed in. If it is, release it by turning the knob clockwise; the knob pops out. From the system rear panel, set the main power switch to the (On) position;...
Operating Instructions Turn on the keyswitch; • The system powers up • System Start screen appears (see Figure 6-2) Figure 6-2: System Start Screen Press the softkey; the screen appears (see Start Handpiece Selection Figure 6-3). Figure 6-3: Handpiece Selection Screen ™...
Operating Instructions 6.5. Select the Handpiece On the Handpiece Selection screen (see Figure 6-3), select the handpiece that will be used for the treatment session: • To select the bipolar handpiece, press the Bipolar softkey • To select the unipolar handpiece, press the Unipolar softkey Wait a few seconds for the system to complete the initialization process;...
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Operating Instructions The following is a brief description of the Main Treatment screen elements, as indicated by the numbered arrows in Figure 6-4: – shows the total energy (in kJ) delivered during the Total Energy Indicator current treatment session. Arrow Softkey –...
Operating Instructions 6.7. Set the Operating Parameters Note If you want to use the default parameters, as they appear on the Treatment screen (see Figure 6-4), you may skip this section. If you prefer not to use the default settings for the current treatment, you can change any of the operating parameters as necessary.
Operating Instructions 6.7.3. Set the Cooling Mode Cooling mode determines if the tissue cooling option is On or Off. On the screen (see Figure 6-4) press the softkey to toggle the Treatment Cooling cooling to on or off: COOLING ON (green) softkey indicates that the cooling mode is on COOLING OFF (red) softkey indicates that the cooling mode is off...
Operating Instructions Note • Blinking RF emission indicators after releasing the trigger or the footswitch indicates that radiofrequency emission has stopped and that the system is in mode. Ready • To cease radiofrequency emission at, any time, release the trigger/footswitch. 6.9.
Operating Instructions Note Saving the settings for one handpiece (bipolar or unipolar) does not affect the default settings for the other handpiece. To save the settings: Set the system in Standby mode. Set the desired operating parameters. Press the SAVE softkey;...
Operating Instructions Clean the handpieces according to the instructions given in Chapter 7 – Maintenance Warning Do not leave the key in the keyswitch unattended. It may lead to unauthorized use of the system. 6.14. Error Detection This system is equipped with self-testing software that continuously monitors system operation by means of watchdog software &...
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CHAPTER 7 Maintenance Chapter Contents: Section Title Page 7.1. Introduction ..................7-2 7.2. Periodic Service ................. 7-2 7.3. Service Information ................7-3 7.4. Routine and Preventive Maintenance ..........7-4 7.5. Filling and Draining the Cooling System .......... 7-5 7.6. Fuse Replacement ................7-8 ™...
Check the water quick-connector O-rings on the handpieces Warning • The Accent XL system generates hazardous voltages within the main console. • The interior of the system may be serviced only by Alma Lasers authorized technical personnel. ™ Accent XL Operator's Manual...
• Improper use or adjustment of this system may invalidate the service warranty agreement. Questions or problems should be referred to your Alma Lasers representative, or to the Alma Lasers Service Centers at: Alma Lasers Ltd. Alma Lasers, Inc.
• Always turn the system off and unplug the power cable before performing maintenance procedures. • The interior of the system or its components may be serviced only by Alma Lasers authorized technical personnel. 7.4.1. Cleaning and Disinfecting the System The outer surface of the system may be wiped clean with a soft cotton cloth swabbed in 70% alcohol.
Maintenance 7.5. Filling and Draining the Cooling System The cooling system must be checked at least once every six months, to ensure that the reservoir contains sufficient coolant. If necessary deionized water should be added. If the system is to be stored in a cold area where the temperature may fall below 0ºC (32ºF), the deionized water must be drained from the cooling system.
Maintenance Connect the funnel tube of the water filling/draining kit to the port on the FILL system service panel as shown in Figure 7-3. Make sure that the elbow fitting (of the funnel tube) clicks into the port's quick connector. Figure 7-3: Connecting the Funnel Tube to the FILL/DRAIN Port Holding the funnel upright, slowly pour deionized water into the system until the water starts dripping from the...
Maintenance 7.5.2. Draining the Cooling System Place a container under the port. DRAIN Connect the white elbow fitting of the water filling/draining kit to the DRAIN port on the system service panel, as shown in Figure 7-5. Make sure that the elbow fitting clicks into the port's quick connector.
Maintenance 7.6. Fuse Replacement To replace burnt fuses: Turn off the system and disconnect the power cable from the outlet. Unplug the power cable from the power cable connection port on the service panel. Remove the fuse housing as shown in Figure 7-6. Remove the burnt fuses from the housing and replace them with the new ones.
Table 8-1 provides a list of alarms and error messages that may appear on the screen, their possible causes and corrective actions to be performed. If the corrective actions listed in the table do not solve the problem, contact your Alma Lasers Service representative.
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1. Turn system off, wait 1 minute and restart; resume normal operation Date Time Error System malfunction 2. If problem persists, call Alma Lasers Service 1. Turn system off, wait 1 minute and restart; resume normal operation FlowSW OFF Error System malfunction 2.
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The handpiece was replaced normal operation Handpiece Changed while the system was turned on 2. If problem persists, call Alma Lasers Service 1. Turn system off, wait 1 minute and restart; resume normal operation Error Wiring Data Data cannot be saved 2.
CHAPTER 9 Ordering Information Chapter Contents: Section Title Page 9.1. Ordering Information Parts List............9-2 ™ Accent XL Operator's Manual...
Ordering Information Parts List This chapter offers information necessary for ordering Harmony accessories. The following table displays the names and part numbers of the items by which you should place your orders with your Alma Lasers distributor. Description Part No.
APPENDIX A Clinical Guide Chapter Contents: Section Title Page A.1. Introduction ..................A-2 A.2. Training Requirements ..............A-2 A.3. Intended Use and Indications............A-2 A.4. Contraindications................A-2 A.5. Special Considerations..............A-3 A.6. Adverse Effects of Treatment ............A-3 A.7. Accessories and Equipment .............. A-3 A.8.
This includes physicians, nurses, technical staff or other professional staff members. Alma Lasers provides in-service training for the Accent XL system. At the end of this in-service training, personnel are considered trained for the operation of the Accent XL system.
Clinical Guide • Photography stand • Mirror • High resolution digital or 35mm film camera • If protective eyewear is used (not required) – only plastic-made eyewear should be used! Warning The use of any water-based (ultrasonic) gel or baby oil on the skin is prohibited! A.8.
Clinical Guide A.9. Photography It is recommended to take “before” and “after” photographs to document the treatment progress. These photographs provide objective evidence, since many patients are not able to assess the progress of treatment with its gradual improvement. Standard conditions and similar camera speed, flash and focal distance should be used to photograph all patients.
Clinical Guide A.10.1. Handpieces: Practical Considerations of Operation and Technique • The treatment consists of the combined use of the two handpieces - Unipolar and Bipolar (see Figure A-1). • The radiofrequency (RF) energy is emitted only when the handpiece tip comes in contact with the skin.
Clinical Guide • During the In-Motion treatment mode the practitioner will move the handpiece (while in contact with the skin) following a circular pattern within the treatment area during each pass (i.e., 30 sec). • In cases when the treatment causes discomfort for any reason (i.e., heat), the practitioner shall immediately release the handpiece trigger (or the footswitch) to cease the RF emission, while keeping the cooled handpiece tip in contact with the skin.
Clinical Guide A.10.3. Treatment Objectives To maintain the treatment area temperature at 106-109.5°F (41-43°C) for a minimum of one minute (60 sec). A.10.4. End-Points • Maintaining the therapeutic temperature of 106-109.5°F (41-43°C). • Skin initially blanches slightly, then appears erythematous and is warm on palpation.
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Clinical Guide 12. Set the power and exposure time and press the softkey. Ready Note The power setting can be tailored during the treatment, depending on the patient’s response. • For moisturized or sensitive skin – decrease the power by 5-10%.
Clinical Guide A.12. Treatment Guidelines in the Periorbital & Perioral Areas There are certain guidelines that should be followed when treating the face: • Avoid the following areas: ⇒ Superorbital ⇒ Mental nerves ⇒ Exits of the sensory nerves of the neck •...
Clinical Guide A.12.2. Bipolar Handpiece • The practitioner will use the bipolar handpiece for a more superficial toning/ tightening in the regions just previously treated with the unipolar handpiece. • Select the handpiece mode from the control panel. Bipolar • During treatment the handpiece must be in complete contact with the skin and slightly pressed towards the skin.
Clinical Guide A.13. Post-Treatment • Gently clean the treatment oil from the skin surface and dry it. • Let the patient rest for 10-15 minutes on the treatment bed. • Patient should drink two glasses of water immediately after the treatment. •...
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