Alma Lasers Accent xl Operator'S Manual Download Page 85

Page: 85 / 98

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.

Pre-Treatment Information ............................................................... A-4

A.9.

Photography...................................................................................... A-5

A.10.

Treatment.......................................................................................... A-5

A.11.

Treatment Protocol ........................................................................... A-8

A.12.

Treatment Guidelines in the Periorbital & Perioral Areas.............. A-10

A.13.

Post-Treatment................................................................................ A-14

A.14.

Follow-Up....................................................................................... A-14

Accent XL

™

Operator's Manual A-1

Summary of Contents for Lasers Accent xl

Page 1: ...O P E R A T O R S M A N U A L R A D I O F R E Q U E N C Y S Y S T E M AAAP11090601...

Page 2: ...ny HarmonyPixel Pixel Sonata Soprano Soprano XL Tenor Hair Removal in Motion DualChill and BlendMode are the trademarks of Alma Lasers Ltd Alma Lasers Ltd 14 Halamish St P O B 3021 Caesarea Industrial...

Page 3: ...Describes the control and service panels footswitch and various connections to the system and functional indicators Chapter 5 Controls and Indicators Explains how to operate the system offering basic...

Page 4: ...itch 2 3 2 2 5 Emergency Shut Off Knob 2 3 2 2 6 Input Power 2 3 2 2 7 RF Emission Indicators 2 4 2 2 8 Radiofrequency Emission 2 4 2 2 9 Output Power Control 2 4 2 2 10 Grounding the System 2 4 2 2 1...

Page 5: ...Connector 3 11 3 9 Storage and Transportation 3 12 3 9 1 Cooling System Drainage 3 12 3 9 2 Moving the System 3 12 CHAPTER 4 System Description Page 4 1 Introduction 4 2 4 2 System Components and Cont...

Page 6: ...6 Handpiece Connection Ports 5 9 CHAPTER 6 Operating Instructions 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...

Page 7: ...1 Filling the Cooling System 7 5 7 5 2 Draining the Cooling System 7 7 7 6 Fuse Replacement 7 8 CHAPTER 8 Troubleshooting Page 8 1 Introduction 8 2 8 2 Troubleshooting Guides 8 2 CHAPTER 9 Ordering In...

Page 8: ...iption Page Figure 2 1 Identification Label 2 9 Figure 2 2 Electrical Requirement and Hazard Label 2 10 Figure 2 3 Shipping Crate Label 2 11 Figure 3 1 System Dimensions 3 3 Figure 3 2 Footswitch Conn...

Page 9: ...ndpiece Connection Ports under the Control Panel 5 9 Figure 6 1 Keyswitch Off Screen 6 3 Figure 6 2 System Start Screen 6 4 Figure 6 3 Handpiece Selection Screen 6 4 Figure 6 4 Main Treatment Screen E...

Page 10: ......

Page 11: ...ontents 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...

Page 12: ...ining 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 tha...

Page 13: ...ce 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...

Page 14: ...le s J Kilogram s Kg Pound s Lb Liquid crystal display LCD Light emitting diode LED Meter s m Millimeter s mm Mega M Pulse width modulation PWM Radiofrequency RF Second s Sec Thermoelectric cooling TE...

Page 15: ...Contents Section Title Page 2 1 Introduction 2 2 2 2 System Safety Features 2 2 2 3 General Precautions and Cautions 2 5 2 4 Equipment Classification and Compliance 2 8 2 5 Device Labels 2 9 Accent X...

Page 16: ...the system safely The supervising physician and all other personnel operating or maintaining the Accent XL must be familiar with the safety information provided in this chapter The primary considerati...

Page 17: ...andpiece Calibration screen These passwords prevent unauthorized modifications of the system s settings 2 2 4 Footswitch The system is equipped with a pneumatic footswitch to eliminate the possibility...

Page 18: ...conditions are met 1 The system is in Ready mode 2 The handpiece trigger or the footswitch is pressed The system does not allow radiofrequency emission in any other condition 2 2 9 Output Power Contro...

Page 19: ...ieces and handpiece tips must be kept clean at all times The system weighs approximately 110 lbs 50 kg and may cause injury if proper care is not used when moving it The system is well balanced and is...

Page 20: ...such as alcohol or acetone in the preparation of the skin for treatment If necessary use soap and water to clean before treatment If alcohol is used to clean and disinfect any part of the Accent XL s...

Page 21: ...devices This equipment has been tested and it conforms to the restrictions for medical devices Those restrictions were designed to bring reasonable protection against harmful interferences in the typi...

Page 22: ...00 4 3 Section 3 Radiated radio frequency electromagnetic field immunity test 2002 IEC 61000 4 4 Section 4 Electrical Fast Transient Burst immunity test 1995 A1 2000 A2 2001 IEC 61000 4 5 Section 5 Su...

Page 23: ...vice panel This label contains the following information Manufacturer s details Name and part number of the system Serial number and date of manufacture The system s electrical requirements CE MDD com...

Page 24: ...label identifies the connection port for the VENT air vent of the cooling system s water reservoir Fill label identifies the connection port for the FILL accessory used by the service technician to fi...

Page 25: ...Safety 2 5 2 Packaging Label The following label is attached to the Accent XL system s shipping crate Figure 2 3 Shipping Crate Label Accent XL Operator s Manual 2 11...

Page 26: ......

Page 27: ...2 3 3 Facility Requirements 3 3 3 4 Connecting the Footswitch 3 5 3 5 Filling the Coolant Reservoir 3 5 3 6 Adjusting the Handpiece Support Arms 3 6 3 7 Connecting the Handpiece 3 8 3 8 Connecting th...

Page 28: ...ootswitch Plug the system into a designated electrical outlet Fill the cooling system reservoir with deionized water Test the system for proper calibration and functional operation of all components a...

Page 29: ...nsions presented in Figure 3 1 In order to guarantee proper ventilation always keep the sides of the system at least 20 0 5m from the wall or from other obstructions to air flow After positioning the...

Page 30: ...nic components and the surfaces of optical components Air borne dust particles should be kept to a minimum Dust particles absorb light and heat up Hot particles located on the optical lenses can damag...

Page 31: ...to use the footswitch for RF emission It is possible to emit RF pulses using only the handpiece s trigger in which case you may leave the footswitch unconnected Figure 3 2 Footswitch Connection Port 3...

Page 32: ...th 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 1 Release the handpiece support arm lock...

Page 33: ...desired height see Figure 3 5 Figure 3 5 Adjusting the Height of the Handpiece Support Arm 3 Fasten the lock by reversing the action shown in Figure 3 4 Note It is recommended to set both handpiece su...

Page 34: ...the Handpiece Holders To connect a handpiece 1 Place the handpiece in the handpiece holder see Figure 3 6 2 Verify that the support arm is raised high enough to enable you to open the control panel wi...

Page 35: ...ing the Handpiece into the Port Note Connect the handpiece to the port that is on the same side as its support arm 5 Engage the hook of the handpiece connector locking handle onto the fastener pin of...

Page 36: ...gure 3 10 Figure 3 10 Pushing Down the Locking Handle 7 Repeat the above procedure to connect the second handpiece Figure 3 11 Connecting the Second Handpiece 8 Close the control panel see Figure 3 12...

Page 37: ...ctor out of the port see Figure 3 8 3 8 Connecting the Dummy Handpiece Connector Refer to Figure 3 13 The dummy handpiece connector A acts as a bypass which enables the system to operate with only one...

Page 38: ...wheel push its brake lever firmly downwards To release move the lever upwards When the system is stationary the brakes must be in the locked position Release the brakes only when moving the system To...

Page 39: ...ER 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 Manua...

Page 40: ...ication system A complete discussion of the handpieces their uses and technical specifications may be found in Section 4 2 4 of this chapter 4 2 System Components and Controls Figure 4 1 exhibits the...

Page 41: ...display the LCD display provides information on the status and settings of the Accent XL system with touch screen technology for system operation The various module screens and their operation are de...

Page 42: ...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 Ha...

Page 43: ...nd cold water tubes cooling system RF power cable and the communication cable that controls the operation of the handpiece Handpiece connector connects the handpiece to its port It incorporates an int...

Page 44: ...rporates a water pump water reservoir radiator particle filter deionizer flow switch and a fan The system circulates water from the fan cooled radiator to the handpiece 4 2 7 Fans Two fans are located...

Page 45: ...meters for the selected handpiece type Note Saving the settings for one handpiece type bipolar or unipolar does not affect the default settings for the other handpiece For detailed instructions on sav...

Page 46: ...de Tampering with the settings in the technician mode may adversely affect the safety and efficacy of the Accent XL system 4 4 System Specifications 4 4 1 Output RF Generator Type RFA400 Output Freque...

Page 47: ...OFF when no RF emission occurs Blinking during Ready mode Illuminating continuously during RF emission Visual illuminating blue indicator on the handpiece Illuminating continuously during RF emission...

Page 48: ...livery System Handpiece Applicator Tips Bipolar Unipolar Skin Cooling Thermo electrical 4 C 39 F Continuous contact tissue cooling 4 4 6 Classifications Mode of Protection against Electric Shock Class...

Page 49: ...Chapter Contents Section Title Page 5 1 Introduction 5 2 5 2 Control Panel Components 5 2 5 3 Service Panel Components 5 6 5 4 Handpiece Trigger 5 7 5 5 Footswitch 5 8 5 6 Handpiece Connection Ports 5...

Page 50: ...t 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 t...

Page 51: ...s used to turn the system on and off Turning the keyswitch clockwise turns the system on Turning the key switch counterclockwise starts the shut down sequence and turns off the system Note In an emerg...

Page 52: ...the control panel and the blue LED on the selected handpiece illuminate both prior to and during radiofrequency emission In Ready mode the red light and the blue LED blink to indicate that radiofreque...

Page 53: ...een 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 The operator controls the system u...

Page 54: ...ousing Footswitch air tube connection port Water fill drain and vent ports Fan grills for air flow to the fans that cool the system s interior and the water in the cooling system Fuse Housing Water VE...

Page 55: ...is in Ready mode Note Only the handpiece that is currently selected can be activated in Ready mode Pressing the trigger of the other non selected handpiece will not have any effect The selected handp...

Page 56: ...ected to its connector on the service panel see Figure 5 3 For detailed instructions on connecting the footswitch refer to Chapter 3 Installation Note Connecting the footswitch is necessary only if yo...

Page 57: ...nection 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 Installation...

Page 58: ......

Page 59: ...m 6 3 6 5 Select the Handpiece 6 5 6 6 Graphic User Interface 6 5 6 7 Set the Operating Parameters 6 7 6 8 Emitting Radiofrequency Energy 6 8 6 9 Pause in Operation 6 9 6 10 Changing Operation Paramet...

Page 60: ...Alma Lasers distributor before attempting to use the system in any manner other than those specified in this manual 6 2 Prepare the System for Operation To prepare the system for operation 1 Connect t...

Page 61: ...it by turning the knob clockwise the knob pops out 2 From the system rear panel set the main power switch to the I On position The Keyswitch Off screen appears on the display see Figure 6 1 The RUN LE...

Page 62: ...he system powers up The System Start screen appears see Figure 6 2 Figure 6 2 System Start Screen 4 Press the Start softkey the Handpiece Selection screen appears see Figure 6 3 Figure 6 3 Handpiece S...

Page 63: ...ent screen in Standby Mode appears see Figure 6 4 6 6 Graphic User Interface The graphic user interface provides the controls and indicators required to operate and control of the system All operator...

Page 64: ...using the V or W softkeys 6 Cooling Softkey toggles to turn the handpiece cooling on and off Blue softkey not pressed indicates Off Gray softkey pressed indicates On 7 Bipolar Unipolar Indicator indic...

Page 65: ...W softkey the Power Selector appears pressed 2 Use the V or W softkeys to set the desired value in the Power indicator For the bipolar handpiece the power can be set between 20 110 Watts in increment...

Page 66: ...ng the trigger or the footswitch will emit radiofrequency energy 6 8 Emitting Radiofrequency Energy 1 Verify that the system is in Ready mode and that the operating parameters are correct for the indi...

Page 67: ...during Operation Any of the operating parameters may be changed during operation as follows 1 Release the trigger or footswitch 2 Change from Ready to Standby mode by pressing the StBy softkey on the...

Page 68: ...witch to the corresponding handpiece type 1 Turn off the Accent XL system as described in Section 6 13 2 Turn the system back on 3 Select the desired handpiece on the Handpiece Selection screen see Fi...

Page 69: ...ly monitors system operation by means of watchdog software circuitry The software continuously checks the hardware for any error condition The LCD displays an error message and disables further operat...

Page 70: ......

Page 71: ...ection 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 Replacem...

Page 72: ...ource Performing maintenance procedures with the system turned on may be hazardous to the operator and or destructive to the system 7 2 Periodic Service The system should be periodically inspected and...

Page 73: ...voltage and laser radiation hazards Improper use or adjustment of this system may invalidate the service warranty agreement Questions or problems should be referred to your Alma Lasers representative...

Page 74: ...piece applicator tips are very delicate Take all necessary precautions in order to prevent scratching the tips The Accent XL handpieces in particularly the applicator tips are cooled intensively when...

Page 75: ...and draining the coolant are performed with the water filling draining kit supplied with the Accent XL system see Figure 7 1 Figure 7 1 Water Filling Draining Kit Caution Never fill the coolant reser...

Page 76: ...ng the Funnel Tube to the FILL DRAIN Port 3 Holding the funnel upright slowly pour deionized water into the system until the water starts dripping from the VENT port 4 Disconnect the funnel tube and t...

Page 77: ...NT port on the system service panel as shown in Figure 7 5 Make sure that the elbow fitting of the funnel tube clicks into the port s quick connector 4 Turn the elbow fitting downwards into the contai...

Page 78: ...nd replace them with the new ones 5 Make sure that the fuses fit snugly within the fuse housing 6 Insert the fuse housing into its receptacle and push it in until it snaps into place 7 Connect the pow...

Page 79: ...CHAPTER 8 Troubleshooting Chapter Contents Section Title Page 8 1 Introduction 8 2 8 2 Troubleshooting Guides 8 2 Accent XL Operator s Manual 8 1...

Page 80: ...empt to open or disassemble the system covers 8 2 Troubleshooting Guides Table 8 1 provides a list of alarms and error messages that may appear on the screen their possible causes and corrective actio...

Page 81: ...esume normal operation 2 If problem persists call Alma Lasers Service System Data Input Overload System malfunction 1 Turn system off wait 1 minute and restart resume normal operation 2 If problem per...

Page 82: ...call Alma Lasers Service Flow SW Error Insufficient coolant flow in the system 1 Add deionized water to the cooling system 2 If problem persists call Alma Lasers Service Table 8 2 System Malfunctions...

Page 83: ...CHAPTER 9 Ordering Information Chapter Contents Section Title Page 9 1 Ordering Information Parts List 9 2 Accent XL Operator s Manual 9 1...

Page 84: ...the items by which you should place your orders with your Alma Lasers distributor Description Part No Bipolar Handpiece AAAP09110503 Unipolar Handpiece AAAP09110502 Dummy Handpiece Connector AAAP0911...

Page 85: ...indications 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 Pre Treatment Information A 4 A 9 Photography A 5 A 10 Treatment A 5 A 11 Trea...

Page 86: ...f 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 The physic...

Page 87: ...ollowing the treatment however it is expected to be mild and to resolve within a few minutes Erythema may be present in the treated area and is likely to disappear within 24 hours Burns can be avoided...

Page 88: ...ability of treatment with the Accent XL system Determine why the patient is seeking treatment and understand his her expectations Discuss the treatment regimen with the patient A 8 2 Counseling During...

Page 89: ...es an objective comparison of photos taken at different times A 10 Treatment The Accent XL system is equipped with two handpieces Bipolar for surface heating Unipolar for volumetric heating The follow...

Page 90: ...issue in the maximal therapeutic temperature range of 106 109 5 F 41 43 C The treatment includes two distinct phases pre therapeutic and therapeutic the goal of the pre therapeutic phase is to raise t...

Page 91: ...iece tip in contact with the skin Application of the stationary mode with the handpiece positioned in place on the skin is strictly prohibited As an alternative technique in cases a specific line fold...

Page 92: ...inical condition screen the patient for skin laxity skin quality and tone conditions 3 Standardize photography conditions and take pictures 4 Establish the patient in a proper position so that the are...

Page 93: ...5 The movement should be circular within the enclosed area of the grid for the duration of the preset exposure time 16 Press the trigger and commence the treatment 17 Monitor the temperature of the tr...

Page 94: ...r will check the temperature using his her hand palpation in order to make sure the therapeutic temperature in the treated area is kept at the correct level Every 30 seconds or when the patient starts...

Page 95: ...of 106 109 5 F 41 43 C should be achieved within one pass of 30 seconds The temperature can be checked using a thermometer Once the therapeutic temperature is achieved the practitioner will check the...

Page 96: ...n as needed from Pass 3 to maintain target temperature and patient comfort 45 55 W 10 reduction as needed from Pass 3 to maintain target temperature and patient comfort 5 30 UP 20 BP 41 43 85 95 W 10...

Page 97: ...re and patient comfort 4 30 UP 20 BP 41 43 85 100 W 10 reduction as needed from Pass 3 to maintain target temperature and patient comfort 45 55 W 10 reduction as needed from Pass 3 to maintain target...

Page 98: ...er treatment alcohol might drain water from the body and skin In order to maintain the treatment results it is highly recommended to apply a moisturizing cream to the treatment area every day A 14 Fol...

Search results

Summary of Contents for Lasers Accent xl

Reviews:

Related manuals for Lasers Accent xl

Brands by name

Popular brands

Alma Lasers Accent xl, Operator'S Manual

Search results

Summary of Contents for Lasers Accent xl

Reviews:

Related manuals for Lasers Accent xl

Brands by name

Popular brands