User Manual
Contents
1. 2 5 Contraindications The SpaTouch Elite should not be used on clients who Used any method of epilation other than shaving in the treatment area within the past 30 days Have inflammatory skin conditions or open sores Are pregnant or lactating Have tanned by sun or artificial tanning machine within the last 21 days Have a tattoo or permanent makeup in the treatment area Have abnormal skin conditions due to different diseases conditions e g diabetes or medicinal intake 8 Revision 02 January 2011 CHAPTER 2 Have a history of skin disorders such as vitiligo or psoriasis in the treatment area Have a history of local skin infections Have been treated with isotretinoin Accutane within the past 6 months Have used any medications herbal preparations or chemicals within the past 6 weeks that cause photosensitivity These include but are not limited to gold therapy tetracycline or sulfa drugs and certain psychiatric medications In case of uncertainty regarding photosensitizing side effects have the client consult their physician Suffer from epilepsy Have diseases related to photosensitivity such as Porphyria Polymorphic Light Eruption Solar Urticaria Lupus and other autoimmune diseases Have a history of herpes outbreaks in the treatment area unless the client has consulted their physician and received prophylaxis treatment prior to treatment Have a history of skin cancer or clients wh2. User Manual Smart Skin Solutions RADIANCY January 2011 Revision 02 2010 2011 Radiancy Inc All right reserved SpaTouch Elite User Manual January 2011 Part Number 2026120 Revision 02 Note The information in this document is confidential and proprietary It is provided to customers and authorized representatives of Radiancy only The content of this manual is furnished for informational use only is subject to change without notice and should not be construed as a commitment by Radiancy Inc LHE and Radiancy are registered trademarks of Radiancy Inc in the United States and or in other countries The Quality Management System of Radiancy Ltd complies with the Quality Management Standard ISO 13485 2003 i Manufacturer Radiancy Israel Ltd 5 Hanagar St P O Box 7329 Hod Hasharon 45240 Israel Tel 972 9 775 7500 Fax 972 9 775 7511 www radiancy com Authorized European Representative Obelis S A Av de REP Tervuren 34 Bte 44 B 1040 Brussels Belgium Tel 32 0 2 732 5954 Fax 32 0 2 732 6003 GSM 07545 4660 e mail mail obelis net Contact Information Customer satisfaction is a Radiancy priority To help us in providing you with the best possible product and support please send us your comments and suggestions Contact us at the addresses and telephone numbers below US Israel Radiancy Inc Radiancy Israel Ltd 40 Ramland Road South Suite 200 5 Hanagar St P O Box 7329 Orangeburg
3. A2D communication fault Handpiece has exceeded its pulse limit Charging over voltage fault E6 E7 E8 E9 F1 F2 F3 F4 F5 F6 F7 38 e Ifthe problem persists shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technicia
4. NY 10962 Hod Hasharon 45240 USA Israel Toll Free 888 661 2220 Tel 972 9 775 7500 Tel 1 845 398 1647 Fax 972 9 775 7511 Fax 1 845 398 1648 E mail service radiancy com E mail info radiancy com TABLE OF CONTENTS Glossary of Terms 1 Introduction to the System 2 System Description 2 1 System Components and Controls rrrrnrrrrrrrrnnnrrnrrrrnnvrnnrrrrnnnnnne 22 VEChniCal MMIORMAHOM a 3isscer cr sei cehted a tied Secah diel aeraddsanoisiee Seanad 235 AV FAUSA 2 4 Major Precautions amp Warnings r rrrrrnnrrrorrrnnnrrnrrernnrrnnrrrrnvnnnsrenn 25 CoMANdCAlbonss je 0 ERE 015 EEE EE ne 2 7 Compliance with International Standards ssrrerrrrnnrrrrrrrrnnrrnrren 3 Initial Set up 3 1 Unpacking SpaTouch Elite rrrrrrrrorrnnrrrrrersnnrrrrsernnrrnrrerrnnrnnerenn 3 2 Electrical Requirements rrnnnnrrnrnvnnnnnnnrrrerrrrnnnnnnnrnrrnnnnnnnnnvssssennnn 9 KANN 4 General Guidelines for the Operation of SpaTouch Elite 5 Operation 51 Turning on Ne Systemerne ae E 5 2 Working with the Touch Panel amp Screen seses 23 EMUN a PUSE ee 5 4 Adjusting Energy LeVel o oo ccccccsssscecccceeessssseeeeceeeeessssseeesees 5 5 About Ready Mode rrrrrrorrnnnnnrrnnrrsennnnnnnrnnnrrennnnnnnnnnnnssennnnnnnnnnesssennn 5 06 System SN DOWN senai i r SE NE E EEE A AE RAE E A EE N E Foe MUG erer a E EE NR TO SENFL 6 Pre Treatment Ol Ghent ARON zra a A A ON 62 ICS EE pa N ON 6 3 n
5. Ready Figure 13 on the Work Screen If you wish to exit Ready Mode during treatment press the Start Stop button once The permanent square outlining Ready will fade a permanent square outline around Wait icon will appear and the system will temporarily go into Rest Mode To reenter Ready mode press the Start Stop button once more 5 6 System Shut Down Press and hold the On Off button KD for 2 seconds to turn system off 22 Revision 02 January 2011 OPERATION 5 7 Alerts e Approaching HP Pulse Limit When the word Approaching appears on the Handpiece section of the Work Screen 1 000 or less pulses remain on the handpiece Figure 14 e HP Pulse Limit Exceeded When the Handpiece exceeds it pulse limit the word Exceeded will appear on the Handpiece Section of the Work Screen Figure 15 Treatment Pulse Count Pulse Count wa a a Figure 14 Approaching Pulse Limit Figure 15 Pulse Limit Exceeded e IMPORTANT NOTE SpaTouch Elite will NOT operate once the pulse limit is exceeded 5 8 Mute e Press the Mute Button to turn off the sound Figure 10 e When the system is in mute mode the word Mute will appear on the Status Section of the Work Screen Figure 16 System Fault e Press the Mute Button again to return sound The word Mute will no longer appear in the Status Section of the Work Panel Figure 17 Status Pulse Count Wait Bondy E Da a a Mute Fault W Figure 16 Mute Ac
6. 8 weeks between each session Set the initial energy level according to test results According to your judgment apply ice non humid such as an ice pack to the site of the next pulse before applying the pulse to increase client comfort Perform one complete pass of the treatment site during each session 7 5 Post Treatment Care Mild redness in the treatment area is normal and can last anywhere from a few hours to a few days Although some hairs remain intact most bleached and or burned hairs usually fall out within two weeks of treatment On the night following treatment clients should avoid bathing in hot water or applying any harsh topical that might irritate the skin such as skin peels Clients should be instructed to cleanse skin with lukewarm water and gentle soap and hydrate it with a suitable moisturizer Advise your client to avoid sun exposure during treatment as well as 21 days before and following treatment Clients may shave from 2 3 days after treatment until 1 week before the next treatment Advise your client to use sunscreen to protect the skin Perform maintenance every 6 months as necessary 7 6 Considerations for Feminine Facial Hair Facial hair is generally obstinate and one of the hardest conditions to treat for successful long term removal Often caused by chronic or life stage hormonal 30 Revision 02 January 2011 TREATMENT PROTOCOLS imbalances it is important to
7. Button Reset Button Mute Button Set Button Buttons On Off Button Figure 10 Touch Panel and Work Screen To activate the buttons firmly yet gently press the button for the desired function Refer to Figure 10 for the location and function of each button e On Off Cy Button turns the system off and on e Start Stop Button switches between Ready and Wait modes e Set Button sets energy level after adjusting it with buttons e Button increases or decreases the energy level e Reset button resets both the Time and Pulse Count e Mute button turns on off the sound feedback after a pulse emission When the system is in mute mode the icon is lit After turning on SpaTouch Elite the Work Screen Figure 11 will appear above the control panel 20 Revision 02 January 2011 OPERATION Handpiece Handpiece Treatment Section ee ae Type Energy Treatment Regular i Section Sensitive Status Sectiont Pulse Count Status Wait Ready Figure 11 Work Screen The screen is divided into 3 sections Figure 11 e Left Handpiece Section This section displays o The type of handpiece attached to the unit o The total number of pulses emitted by that handpiece o An alert when that handpiece approaches its pulse limit e Center Status Section This section displays o The energy level from 1 100 o The device s readiness to emit a pulse Wait or Ready e Ri
8. hair they should consider together with the patient the possibility of early termination SpaTouch Elite User Manual 31 8 MAINTENANCE 8 1 Cleaning Instructions Caution e Before cleaning the handpiece and main unit always turn the unit off disconnect it from energy and wait a minimum of 5 minutes e Do not use cleaning solutions that contain ingredients that may harm plastic such as ammonia acetone hydrochloric acid HCl chlorine bleach etc 8 1 1 Lamp amp Reflector During treatment debris accumulates on the lamp This may affect performance and the life of the lamp Use the supplied cleaning tool to clean the lamp after each treatment Figure 19 Tip A Use this end to clean between the lamps and reflector OG Tip B 4 Use this end to clean DE between the lamps ee NE Figure 19 Handpiece Cleaning Tool 1 Put 2 drops of alcohol on the sponge part of the cleaning tool Figure 20 ete sd KEN x Ak Vi 7 kiida e s I APR Figure 20 Applying Alcohol to the Cleaning Tool 2 Use Tip B to gently rub along the length of the lamps between the two lamps until the debris is removed Figure 21 32 Revision 02 January 2011 MAINTENANCE Figure 21 Cleaning the Lamps 3 Use Tip A to gently rub along the length of the lamps between the lamp and reflector until the debris is removed Figure 22 IMPORTANT Do not let the sponge part of the cleaning tool touch the refle
9. power cable not be placed on the same circuit as devices with heavy variable loads such as air conditioning units SpaTouch Elite User Manual 13 CHAPTER 3 The fuses located within the unit are rated 5x20T 250V 6 3A for 100 240VAC Be sure to use the appropriate fuse for your region s electrical requirements When a fault in the system occurs the fuse will burn out and the system will not run 3 3 Installation SpaTouch Elite is designed for easy installation and does not require any on site preparation Installation is carried out as follows Unpack the system and place it in a designated location It should be placed on a flat stable surface such as table counter or sturdy cart Verify that the system is intact and that all its components are present Verify that the nominal voltage recorded on the underside of the unit conforms to the electrical voltage of your country 100 120V 220 240V 3 3 1 Handpiece Connection Connect the Handpiece according to the following instructions Figure 7 a Align the Handpiece power and air connectors with its power outlet and air suction inlet Use the metal prongs as a guide bs i Connected nap INTO place handpiece Power and air connections Figure 7 Handpiece Connection 14 Revision 02 January 2011 INITIAL SET UP Note Turn the system off and unplug it from the electrical outlet before replacing or exchanging handpieces To remove
10. system console conforms to the electrical voltage of your electrical outlet Make sure that the electrical outlet has proper grounding Do not open SpaTouch Elite s outer case as dangerous voltages are present inside the system Only Radiancy certified personnel are authorized to perform service within the protective covers of SpaTouch Elite This system may not be operated or played with by children Children must be supervised when they are around or near the system 6 Revision 02 January 2011 CHAPTER 2 e Persons with reduced physical sensory or mental capabilities or lack of experience and knowledge may not operate the system unless they have been given instruction and are under supervision 9 To perform routine maintenance always shut down the system Disconnect power and wait a minimum of 5 minutes Performing maintenance procedures while the system is connected or less than 5 minutes from disconnection may be hazardous to the operator and destructive to the system Never use any flammable substance such as acetone or alcohol on the skin prior to treatment Never use flammable substances or harsh chemicals to clean or disinfect any part of the SpaTouch Elite system 9 Always make sure to completely lift the Handpiece off the client s skin between pulses in order to avoid excessive heating of the handpiece or skin When the Handpiece is replaced repeat testing procedures for ea
11. the handpiece a Push button on back of connector b Gently pull and pop out connection After the handpiece s are connected e Plug the system into a designated electrical outlet e Test the system for proper operation When not in use always make sure the handpiece is in its cradle Do not drop the handpiece This may cause damage to the lamp and handpiece SpaTouch Elite User Manual 15 4 GENERAL GUIDELINES FOR THE OPERATION OF SPATOUCH ELITE The general guidelines below are relevant for all SoaTouch Elite applications To insure client safety attain optimal clinical results and protect device performance operators should adhere to the following protocols Activate Turn on the system Set Energy Levels Always use the test energy levels defined in Table 4 as a starting point Position Handpiece Always position the Handpiece in full contact with the skin with 15 20 overlapping After the pulse is administered immediately and completely remove the handpiece from the skin Apply Pulse Press the footswitch With the footswitch pressed simultaneously push the handpiece pulse switch Rest Between Pulses Remove the handpiece completely away from the skin to prevent preheating the skin Apply Additional Pulses To trigger the next pulse wait until the Ready indicators are lit and the audible signal is heard Place the Handpiece on the next treatment spot and repeat WARNING To avoid eye dis
12. 0335 1 EN 60335 2 27 Household and similar electrical appliances Part 1 EU Directives Low Voltage Directive 2006 95 EC Electromagnetic Compatibility Directive 2004 108 EC The CE mark represents the compliance to the European Low Voltage Directive 2006 95 EC and the Electromagnetic Compatibility Directive 2004 108 EC 12 Revision 02 January 2011 3 INITIAL SET UP 3 1 Unpacking SpaTouch Elite The SpaTouch Elite system is supplied with the following components e Main Unit console e 1 Standard Handpiece o Optional Handpieces e XL Handpiece e Handpiece for sensitive skin V VI e Client Safety Goggles e 3 Small Area Adaptors o Not compatible or available with the XL handpiece e 1 pack of 10 hygienic rings e Footswitch e Power Cable e User Manual e 2 Fuses e Treatment Coat The V VI handpiece addresses the comfort safety and efficacy issues of treating clients with skin types V and VI 3 2 Electrical Requirements Before unpacking SpaTouch Elite make sure the work site meets the following electrical requirements SpaTouch Elite requires a separate single phase supply line with nominal voltage according to the local line voltage e Single phase 100 240 VAC 50 60 Hz 6 3A SpaTouch Elite is grounded via the grounding conductor in the power cable that is plugged into the wall power outlet Good grounding is essential for safe operation of the device It is recommended that the system s
13. I you must use the optional V VI handpiece Do not use the standard handpiece 7 1 Indications The SpaTouch Elite treatment is indicated for clients in good general health 18 years of age or older with Skin Types I VI according to Fitzpatrick Skin Type Classification 7 2 Pre Treatment Trimming Prior to testing or treatment the hair should be trimmed to a length of 1 2 mm or shaved 3 6 days before treatment and left to re grow to the desired length of 1 2 mm Skin Preparation Clean dry and cover spots Be sure there are no unattached hairs left on the skin surface before beginning treatment 7 3 Pre Treatment Test Set the energy level for the first pulse according to the table below Table 4 Energy Level Setting 15 Pulse 204 Pulse For example if the client has skin Type Ill the energy level for the first test pulse should be set at 35 Pulses should be applied on adjacent test spots include test spots on the intended treatment area 28 Revision 02 January 2011 TREATMENT PROTOCOLS 7 3 1 Required Reaction Darkening burning of the hair Skin redness around the hair Perifollicular erythema immediately or within 10 15 minutes after pulsing eNote for advanced users The optimal result is achieved when the hair in the majority of the pulse area has completely disintegrated If the energy level you re using provides good results but still not optimal you may attempt to raise
14. ake into consideration whether or not the client heals darker in the area of an injury or scratch or have a history of keloids or hypertrophic scarring This can reveal a potential for pigmentary changes after burns Keep in mind that the client s skin tone may appear darker during the summer when there is greater Sun exposure SpaTouch Elite User Manual 25 CHAPTER 6 f there is any doubt regarding actual skin photo type always start treating the client according to the higher option e g a client is skin Type Ill or IV treat him as a skin Type IV Caution As some clients may have a delayed reaction to the light flash do not perform more than 3 test pulses during the first test session Wait at least 24 hours before administering the first treatment For clients with Fitzpatrick Skin Types IV VI we recommend waiting at least 48 hours to evaluate the test results 6 5 2 Prior to Treatment It is highly recommended to take photos of the treated area before during and at the end of the treatment Thoroughly clean the area to degrease the skin and remove any remains of cream makeup or topical anesthesia Do not use any flammable solutions such as alcohol or acetone to clean the treatment area Ensure that the skin surface is completely dry Cover moles and pigmented spots with non flammable white sticker or styptic pencil When treating the face 1 Draw back the hair and cover it 2 Provide prot
15. as blistering changes in texture and hypo or hyperpigmentation These side effects are usually transient and should resolve themselves within a few months In case any serious side effects occur refer to the Adverse Effects Report Chapter 12 If the effects match any of the criteria found there copy then fill out the form and send it by FAX or email to your Radiancy Distributor and to Radiancy Ltd within 48 hours of noticing the effects Revision 02 January 2011 PRE TREATMENT 6 3 Informed Consent Form Have the client sign an Informed Consent Form ICF indicating that they consent and agree to the treatment and that they understand and agree to the procedure and its potential side effects Keep on a hard copy file all client records including pre treatment photographs 6 4 Anesthesia Topical or general anesthesia is not required Should the client feel discomfort however it may be recommended Ice packs may be used or if a topical anesthesia is applied carefully follow the manufacturer s instructions 6 5 Pre Treatment Preparations 6 5 1 Determining the Client s Skin Type To evaluate clients skin type use the Fitzpatrick Skin Type Classification scale FITZPATRICK SKIN TYPE CLASSIFICATION Always burns never tans II Always burns tans less than average Ill Sometimes burns tans average IV Rarely burns tans with ease V Moderately pigmented always tans VI Deeply pigmented never burns T
16. ch client during the first 500 pulses 2 4 2 Warnings e Verify that all safety measures are working properly Delivering excessive energy to the treatment site may cause thermal damage to the skin resulting in burns crusting or abnormal pigmentation As a safety precaution always have a first aid kit equipped to treat burns at your disposal e Although SpaTouch Elite is considered an eye safe device when operated according to instructions supplying clients SpaTouch Elite User Manual 7 SYSTEM DESCRIPTION with protective eyewear during facial treatment will provide extra protection against discomfort from light exposure Never look directly at the light coming from the handpiece as this may cause temporary eye discomfort Look away during the flash to further prevent discomfort Never allow the handpiece to emit a pulse into free space Always make sure that the Handpiece is pointed at and in full contact with the skin during pulse application Even when the Energy level on the screen is set at 0 the system can still trigger a pulse Therefore be aware of the position of the Handpiece at all times to avoid accidental flashing Always remain in visual contact with the screen to ensure that the established energy is the correct working energy Pigmented moles and beauty spots and any suspicious abnormal pigmented lesion should be covered with a non flammable white sticker
17. comfort never look directly at the light emitted from the Handpiece Overlapping Overlap pulses between 15 20 Stacking placing one pulse on top of the other and or excessive overlapping can cause crusting or blisters which can lead to temporary pigmentary changes Area Adaptors The Area Adapters should be used when treating small or narrow areas No energy level adjustments are necessary when using the small area adaptors Hygienic Rings Use a new hygienic ring for each client You may reuse the same hygienic ring for the same client Remember to clean it after each use 16 Revision 02 January 2011 GENERAL GUIDELINES New Handpiece Retest Each time an old Handpiece is replaced with a new one the testing procedure for all existing clients should be repeated for the first 500 pulses Excessive Energy Level Stop treatment if overall redness of the treated area is observed Full redness of the area may indicate use of an excessive energy level It is recommended to treat with caution especially during the initial treatments Post Treatment Mild redness and regional pain may be noticed in the treatment area and can last from a few hours up to a few days Most clients will feel some discomfort for up to an hour or two after treatment A post treatment preparation e g Biafine or Aloe can be used to help soothe the area but should not be used on skin with open wounds Cold packs alternately applied
18. ctor The black part will automatically clean the reflector as you clean the lamp Figure 22 Figure 22 Cleaning the Reflector 4 Gently remove the remaining debris with a clean damp lint free cloth or a cleaning wipe 5 Make sure the lamp and reflector are completely dry before the next treatment 8 1 2 Main Unit Cleaning of the main unit system console should be done with a soft nonabrasive cloth moistened with mild detergent or soap suitable for external cleaning of electrical equipment Avoid getting cleaning solution into the machine Spray the solution directly onto the cloth and not onto the unit itself SpaTouch Elite User Manual 33 CHAPTER 8 8 2 Parts amp Attachments 8 2 1 Handpiece Replacement The handpiece must be replaced every 20 000 pulses Remove the handpiece from the system and return it to your Radiancy representative for a replacement Remove the handpiece by pressing down on the top button and pulling straight out Attach new handpiece according to directions found in section 3 3 1 8 2 2 Area Adaptors The Area Adaptors are used when treating different size and shape areas For hygienic reasons clean the area adaptor between each client with a soft damp cloth as you would the handpiece Figure 23 Area Adaptor To install the Area Adaptor Hold the adaptor in one hand and the handpiece in the other Place the adaptor on the handpiece as shown in Figure 1 Ali
19. ective eyewear for client WARNING Pigmented moles and beauty spots should be covered with a white sticker Do not use flammable material 26 Revision 02 January 2011 PRE TREATMENT 6 5 3 Pre Treatment Test The purpose of testing is to get to know your clients skin characteristics understand its sensitivities and to establish the pulse energy level for your client s first complete session Optimal energy level settings differ between clients skin types treatment areas and applications The energy levels in the test tables are intentionally conservative and are meant as a starting point From this starting point you should be able to pin point the highest and safest energy level for your client Stay in constant verbal contact with your clients to learn exactly how the treatment is affecting them what they are feeling and if they are comfortable This will help you decide whether or not to use a higher energy level 6 6 Post Treatment Care In addition to post treatment care described in Chapter 4 advise the client to avoid bathing in hot water facial peeling creams or preparations that may irritate the skin for 24 hours following treatment Advise your client to avoid sun exposure during treatment as well as 21 days before and following treatment Advise your client to use sunscreen to protect the skin SpaTouch Elite User Manual 27 7 TREATMENT PROTOCOLS IMPORTANT When treating skin types V V
20. er receiving SpaTouch Elite and operating it for the first time please fill out this Warranty Card and send to Radiancy Israel Ltd 5 Hanagar St P O Box 7329 Hod Hasharon 45240 Israel SpaTouch Elite Warranty Card User Information System Details l Serial Number Name Street Purchase Date City Comments State Zip Code Tel Fax Mobile E mail Was the system received without visible external damage Yes No Please describe Did the system operate properly immediately after installation Yes No Please describe SpaTouch Elite User Manual 43 RADIANCY INC 40 Ramland Road South Suite 200 Orangeburg New York 10962 USA Tel 1 845 398 1647 Fax 1 845 398 1648 Toll Free 1 888 661 2220 www radiancy com RADIANCY INC RADIANCY LTD 2010 2011 Radiancy Inc All Rights Reserved L LOZ Menuer Z0 ASY 0ZL9Z0T
21. f rmed Consent FOMM ncsceicsscesc dc ccoseeeadenseccccsecesabasuen cas a oaasi 6 4 PENNEN 6 5 Pre Treatment Preparations rrnnnrnrrnnrrnrnnnnnnnrrrrrrnrrrnnnnnnrrrrrnnnnnnenee 6 6 Post Treatment Gale Las Oeeaddedendeteesedes 7 Treatment Protocols Pele TON NN 7 2 FE NENNE TD PE TANNER LAs Mk Pbl avs Fos PM VENN 7 6 Considerations for Feminine Facial Hair ssswrnnnnnnnnnnnnerrnnnnnnnnn 8 Maintenance 8 1 Cleaning INSTUCHONS suvassras s ren 8 2 Parts amp Attachments Luvssssrsassnueesllnlansmmisik 9 Troubleshooting 10 System Errors 11 SpaTouch Elite Service 12 Adverse Events Report Form 13 Warranty LIST OF FIGURES Figure 1 SpaTouch Elite Main System rrrnnnrnnnnnnrnnrnnnnvnrnnnnrnvnnnrnnnnnnsnnvnnnnrnnnnnnsnn 2 Figure 2 Front View of Console amp Panel rrnnnnnnnnnnnnnnnnnenrnnnnennnnnnrnnrnnnnennnnsnennnnnsnn 3 Figure 3 Handpiece Connections rrrrrnnnnrnvnnnnvrvnnnrnnrnnnrvnrnnnnrnnnnnnrnnnnnnsnnnnnnrnnnnnnsene 3 Figure 4 Back P AN leicesis se isaissaccavteseditetiusieelasguetaakte i dideisadtnalie tenieec tind sider 4 Figure 5 Handpiece nrrrnnnrrnnnnennnnnennnnnennnnnvvnnnrsnnnnennnnnennnnennnnnennnnnesnnnsnnnnnennnnnennnnee 4 Figure 6 Footswitch arennnnennnnnernnnnvrnnnnvvnnnvnnnnnennnnennnnnennnnnennnnnnnnnnsennnnennnnennnnsennnnne D Figure 7 Handpiece Connection rranrnrnnnnnvnnnnnnrnvrnnnnenrnnnnennnnnnnnnnnenennnnsnennnnsssnnnnnsne 14 Fig
22. for 10 15 minutes on the affected area are another post treatment option If blistering or burns occur apply first aid for burns and direct your client to seek medical consultation and treatment if necessary If skin crusting occurs do not continue treatment until the crusting has resolved and completely healed Sun Exposure The client should be advised to avoid sun exposure and or artificial tanning devices for a minimum of 21 days before and after treatment If hypo or hyper pigmentation occurs the client should continue to be diligent about sun or light exposure until it resolves Pigmentary changes generally resolve within a few months and may be treated with daily application of sunscreen and bleaching creams Early Termination Hair Removal treatment results should be evaluated after 4 7 treatments depending on the case If you do not observe at least 30 reduction of hair after 4 5 treatments you and your client should consider the possibility of early termination Vellus Facial Hair Do not attempt to remove vellus facial hair as induced hair growth may result SpaTouch Elite User Manual 17 CHAPTER 4 18 Facial Hair Before treating clients with excessive facial hair growth see section 7 6 Photo History Radiancy highly recommends that base line pictures be taken before the first treatment and periodically throughout the treatment course This photo history may be presented as part of the consent form Fine Hai
23. ght Treatment Section This section tracks pulses and time for each treatment It displays o the elapsed time of current treatment o the number of emitted pulses for the current treatment o The fields in this section may be reset by pressing the Reset button located on the touch panel Figure 10 5 3 Emitting a Pulse To emit a pulse 1 Turn on the system see section 4 2 A blinking square will appear around Wait Figure 12 System Readiness Wait 2 Adjust the energy level using the buttons SpaTouch Elite User Manual 21 CHAPTER 5 3 Press the Set button to confirm your energy level selection A blinking square will appear around Ready Figure 13 4 Press the Start Stop button to switch into Ready mode A permanent square will appear around Ready when the system is ready to emit a pulse Status Status Wait Ready WE Ready Figure 12 System Readiness Wait Figure 13 System Readiness Ready 5 Emita pulse Place the handpiece over the targeted treatment area Simultaneously press the foot and the HP pulse switches 5 4 Adjusting Energy Level e Adjust energy level using the buttons e Press the Set button to confirm energy level selection e Press the Start Stop button to enter Ready mode 5 5 About Ready Mode SpaTouch Elite will only emit pulses during the Ready Mode The Ready Mode is indicated by two methods e An audible signal e A permanent square will outline
24. gn the two tabs with the openings on the small ends of light unit Gently press until you hear a clicking sound signaling that the adaptor is firmly in place To remove the Area Adaptor Hold the adaptor in one hand and the handpiece in the other Gently pull off the adaptor 34 Revision 02 January 2011 MAINTENANCE 8 2 3 Hygienic Rings Use a new hygienic ring for each client Simply place the hygienic ring over the lamp opening and push gently into place 8 2 4 Fuse Replacement Turn off the unit and disconnect the system from the electrical outlet Wait 5 minutes Pull out the fuse drawer located in the back panel Replace the fuse and push the drawer back into position Main Power Switch Fuse Panel M Power Cord Inlet Figure 24 Fuse Location SpaTouch Elite User Manual 35 9 TROUBLESHOOTING Situation Symptom Possible Cause Solution The On Off switch on The system does not turn on Numbers are not shown on the display and the lights are off The Ready signal is not heard when the system is ready A pulse is not triggered when pressing on the Handpiece pulse switch The cooling air flow is weak the back panel of the system is in the Off position Power cable is disconnected The Mute switch is on The Footswitch was not pressed The main unit has not completed the recharging cycle The Handpiece pulse switch was pressed before pressing the Fo
25. irective 2004 108 EC 120 240 VAC Voltage label appears on the outer package The C Tick mark represents compliance to Australian rart EMC Regulations 10 Revision 02 January 2011 CHAPTER 2 Additional stickers found on the main unit and the handpieces include serial numbers of system parts and usage warnings Table 3 Additional Labels RADIANCY Model SPATOUCH ELITE P N 3013200 AN Rating 100 240VAC 6 3A 50 60HZ Located on the back of the system this label SN SEYYMMXXXXX includes manufacturer details voltage U QM 000 A OT OTOI IN information and the system s serial number US Patent 5 759 200 Made in Israel RADIANCY Israel Ltd No 5 Hanagar St Hod Hasharon 45240 ISRAEL RADIANCY SpaTouch ELITE HANDPIECE PN 3013010 SN HSYYMMXXXXX NL Hi Handpiece label located on the SpaTouch Elite handpiece 100 240VAC Fuse 5x20T 50 60HZ 250V 6 3A On rear panel NEVER TRIGGER A PULSE UNLESS THE HANDPIECE OPENING IS IN FULL On rea r panel E CONTACT WITH THE TREATED AREA HIGH VOLTAGE OR THE ABSORBING PAD KEEP OUT VISIBLE TO NEAR INFRARED LIGHT This warning appears on all handpieces next to opening SpaTouch Elite User Manual 11 SYSTEM DESCRIPTION 2 Compliance with International Standards The SpaTouch Elite complies with the following international standards and directives EMC Standards EN 55014 1 EN 55014 2 EN 61000 3 2 EN 61000 3 3 Harmonized Standards EN 6
26. n Shut down the system using the power switch on the back of the system Wait 5 minutes and replace the handpiece before restarting the system Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Revision 02 January 201 1 11 SPATOUCH ELITE SERVICE Radiancy Radiancy Israel Ltd Tel 972 9 775 7500 Israel 5 Hanagar St P O Box 7329 Fax 972 9 775 7511 Hod Hasharon 45240 ISRAEL service Qradiancy com Radiancy Radiancy Inc Toll Free number North America 40 Ramland Road South Suite 200 888 661 2220 Orangeburg NY 10962 USA Tel 1 845 398 1647 Fax 1 845 398 1648 info radiancy com SpaTouch Elite User Manual 39 12 ADVERSE EVENTS REPORT FORM Date of Report In the case of any of the adverse events listed below please complete this form and send a copy to your distributor and Radiancy Ltd no longer than 24 48 hours after you learn of the occurrence Retain a copy for your own records Radiancy Israel Ltd 5 Hanagar St P O Box 7329 Hod Hasharon 45240 Israel FAX 972 9 775 7511 info radiancy com Adverse Event Any unwanted medical occurrence in a subject whether or not it is device related Outcomes attributed to the adverse event Hospitalization mm dd yy Required intervention to prevent permanent impairment damage Disability or permanent damage Death mm dd yy Other serious imp
27. n the principle of selective photothermolysis utilizing specific wavelength range and pulse duration to selectively coagulate the hair follicles with minimal effect to the surrounding skin tissue SpaTouch Elite consists of a console a footswitch and one handpiece The handpiece contains a pulse switch a ready indicator light and one treatment lamp The handpiece is held by the operator and placed directly upon the treatment area The operator then simultaneously presses the footswitch and the pulse button to emit the therapeutic pulse In this manual the term operator applies to all qualified personnel trained to operate the SpaTouch Elite system Important Note The SpaTouch Elite user manual is meant as a starting point for treatment a reference guide of general recommendations As you gain more experience with the device you may use your personal expertise to better individualize treatment parameters SpaTouch Elite User Manual 1 2 SYSTEM DESCRIPTION This chapter provides a detailed description of the SpaTouch Elite system its main components controls and technical specifications Please review this material to familiarize yourself with controls ports and connectors as well as the consumable items used during treatment 2 1 System Components and Controls The SpaTouch Elite system consists of the following main components Figure 1 e System console main unit e Handpiece e Footswitch Handpiece Cons
28. nd handpiece buttons are pressed simultaneously 4 Revision 02 January 2011 CHAPTER 2 Figure 6 Footswitch 2 2 Technical Information Table 1 Technical Specifications 4 11 J cm Standard 25 x 50 mm Adaptor Sizes 13 x 50 mm 13 x 35 mm 13 x 12 mm XL optional 35 x 50 mm Pulse Generation Method Capacitor bank electrical discharge switch Physical Dimensions 43 cm x 43 x 22 cm 16 93 x 16 93 x 8 66 in w d h 7 kg 15 43 Ibs Electrical Requirements Single phase 100 240VAC 50 60Hz 6 3A 50 60 Hz Operation Conditions 5 Humidity 30 80 RH Temperature 20 80 C Humidity 0 95 RH 0 1 1 5 atm SpaTouch Elite User Manual 5 SYSTEM DESCRIPTION Many features were built in to the SpaTouch Elite to help insure the safety of 2 3 Safety Features the user and client The following are a few examples Pressing the Start Stop button when the confirmation screen appears ensures the operator has selected the correct treatment mode and or protocols The Ready indicator light on the handpiece advises the user when the system is charging unlit or ready to emit a pulse lit The Footswitch prevents accidental pulses An internal and independent safety electronic circuit shuts down pulse flashing ability in the event of a disabled blower 2 4 Major Precautions amp Warnings 2 4 1 Precautions Verify that SpaTouch Elite s nominal voltage see label at the bottom of the
29. nnrrrrnnnrrrnnnrnrannrrnanrnnannernanrnnnnnsnrnnnrnrannrnnansnnnn 5 Table 2 International Standards Labels rrrrrarrrrrnnnrrrvrnnnrrrrnnnrennnnnernnnnrrrnrnnenennnnn 10 Table SAC ONal LADGIS eee dash 11 Table 4 Energy Level Setting cccccccsccccsssseeccesseecceceecsegeeecsegseeseeuseesssaseeesaneees 28 Table 5 Treatment Course Recommendations rnrrrnrrnnnrvvrnnnnvnvnnnrnvrnnnrrnrnnrennnnn 31 Table 6 List of System Esrors cccccccccssscccceeseeeceesseecceseeecsageecseuseeessseeesseneessseaes 3 GLOSSARY OF TERMS Efficacy The ability to produce a desired effect Erythema A reddening of the skin Hyperpigmentation A skin condition in which there is excessive pigmentation often seen as dark spots on the skin Hypopigmentation A skin condition in which there is a lack of pigmentation The skin appears paler than normal Keloids Hypertrophic scarring Smooth pink raised firm fibrous growths on the skin that form secondary to injury Photosensitivity Extreme sensitivity to the sun leaving the patient prone to sunburn Some medicines have this side effect Pigmentation The amount of melanin molecules containing color in the skin hair amp eyes Vellus facial hair Fine baby peach fuzz hair that is not easily visible to the naked eye vi 1 INTRODUCTION TO THE SYSTEM SpaTouch Elite is a Light amp Heat Energy LHE based device for the treatment of Hair Removal HR It is based o
30. o have areas of potential skin malignancies Have received chemotherapy or radiotherapy treatments within the past 5 years should not be treated without their acting physician s consent Have been on a steroid regimen i e asthma over the last 3 months Have an active implant such as a pacemaker incontinence device insulin pump etc Have any other condition which in the practitioner s opinion would make it unsafe for them to be treated SpaTouch Elite User Manual 9 SYSTEM DESCRIPTION 2 6 Labels This section describes the labels affixed to SpaTouch Elite It is recommended that users review the meaning of these labels for everyday use and in case any details are needed for service The table below briefly reviews a number of the internationally recognized symbols that are found on the SpaTouch Elite main unit and its external package Table 2 International Standards Labels A Attention consult accompanying documents before use Attention consult accompanying documents before use a _ Authorized representitive in the European community Degree of protection against electric shock Type BF applied part Protect the environment by not disposing of this product with household waste 2002 96 EC Check your local authority for recycling advice and facilities Europe only The CE mark represents the compliance to the European Low Voltage Directive 2006 95 EC and the Electromagnetic Compatibility D
31. ole Footswitch Figure 1 SpaTouch Elite Main System 2 Revision 02 January 2011 CHAPTER 2 2 1 1 Main Unit System Console The main unit controls the operation of the entire system It includes the following major parts Front View e Operation Panel Display Screen On Switch Handpiece Cradle Handpiece Cradle Display Screen Operation Panel Figure 2 Front View of Console amp Panel Right Side View e Handpiece power and air connections HP connections Figure 3 Handpiece Connections SpaTouch Elite User Manual 3 SYSTEM DESCRIPTION Back View e Power Cord Inlet Main Power Switch Fuse Drawer Footswitch Port System Fan Outlet Air Exhaust Port System Fan Outlet Main Power Switch Fuse Drawer Power Cord Inlet 2 I TERN i E aa Air Exhaust Port Footswitch Port Figure 4 Back Panel 2 1 2 Handpiece The handpiece connects to the main unit by a spiral cable containing electrical wiring and an air suction hose The Handpiece consists of an LHE lamp pulse switch and pulse counter When not in use the handpiece should be stored in its niche on the front of the main unit Warning Do not drop the handpiece This may damage the lamp handpiece Green Ready Indicator Lights Pulse Switch Figure 5 Handpiece 2 1 3 Footswitch The footswitch arrives connected to the main unit The system will emit a pulse only if the footswitch a
32. ortant medical events Submission of a report does not constitute an admission of fault o that the medical personnel facility importer manufacturer or product caused or contributed to the event Client Information First Name Last Name Age Gender Female Male Treatment Administration Date of event mm dd yy 40 Revision 02 January 2011 Please specify device used Device Name Company Serial Number Where was the treatment done Name of Facility Address Who performed the treatment Full Name Title Who is preparing and submitting this report Full Name Title What sort of treatment was performed What was the treatment area First time the adverse effect was observed mm dd yy 1 J Date the adverse effect resolved mm dd yy Please describe in detail the event or problem If there is not enough room continue on other paper and attach to report Treatment discontinued Yes No If yes provide an explanation for discontinuation SpaTouch Elite User Manual 41 Please attach and list all relevant documentation client file discharge report etc Please include any other relevant client history including any preexisting medical condition s Relation to the Treatment _ Probable _ Possible Probably not _ Not related 42 Revision 01 September 2010 Event Outcome Resolved _ Improved Unchanged Worsened 13 WARRANTY Aft
33. otswitch The handpiece is worn out Improper locking of lamp into Handpiece caused darkening of contact points Rupture in the Handpiece spiral tube 36 Revision 02 January 2011 Toggle the On Off switch to the On position Toggle the On Off switch to the Off position Check that the power cable is plugged into the electrical outlet and connected to the main unit power inlet Check the fuse inside the fuse Blown fuse drawer Replace fuse if blown Press the Mute button to turn it to off Simultaneously press the Footswitch and Handpiece pulse switch Wait for the steady Square Ready indicator to be lit on the panel Release the pulse switch on the Handpiece Then simultaneously press and hold the Footswitch and the Handpiece pulse switch Check the number of pulses that were performed with the handpiece Replace If over 20 000 pulses Stop system operation Call Radiancy service immediately Replace the Handpiece 10 SYSTEM ERRORS lf a system error occurs one of the following appears on the work screen E1 E2 E3 E4 E5 E6 E7 E8 E9 F1 F2 F3 F4 F5 F6 or F7 In all instances begin by turning off the system using the main power switch located on the back Wait 5 minutes and then turn on the system If the error persists follow the steps mentioned below Do not remove the cover to open the system and attempt to fix the problem yourself This will void your warranty and or agg
34. r If the chosen energy level provides expected results on most treated areas but is not sufficiently effective on fine hair energy may be increased to reach required results on those treatment areas When to Retreat Schedule treatments an average of 21 28 days apart There should be at least 30 regrowth Reevaluating Energy Levels Energy levels should be reevaluated during each treatment and for each treatment area Raising the Energy Level As treatment progresses the remaining hair will turn lighter in color and texture Raise the energy levels accordingly keeping in mind your client s comfort and safety Hair and Skin Color In all cases hair must be darker than the skin even slightly for successful treatment Maintenance Perform maintenance treatments as needed Revision 02 January 2011 5 OPERATION 5 1 Turning on the System 1 Turn on the main power switch Main Power Switch f r AN md Figure 8 Main Power Switch Location 2 Press and release the on D button On Off Button Dy Figure 9 Location of On Off Button Switch 5 2 Working with the Touch Panel amp Screen SpaTouch Elite s intuitive touch panel is designed to guide you through the entire treatment process It is recommended to read this section carefully and to become completely familiar with the user interface before beginning treatment SpaTouch Elite User Manual 19 CHAPTER 5 Work Screen Touch Panel Start Stop
35. ravate the problem Table 6 List of System Errors Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Make sure nothing is physically blocking the fan Shut down the system using the power switch on the back of the system Wait 5 minutes and then Fan fault restart the machine If nothing is blocking the fan and the problem persists shut down the system and contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system and wait 5 minutes Detach the handpiece and then reattach it making Handpiece is sure it is properly connected not properly Turn the system on once again using the main connected power switch If the problem persists shut down the system and contact Radiancy or a Radiancy authorized technician Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy authorized technician Blower fault Charging fault e Make sure you are using the SpaTouch Elite Unrecognized handpiece and not a Mistral or Kona handpiece handpiece Fault e lf the problem persists follow the steps for solution indicated for E3 SpaTouch Elite User Manual 37 Handpiece CHECKSUM fault 300V fault 600V fault Discharge fault o MUX Fault Blower communication fault Handpiece communication fault Digital POT communication fault
36. the energy level in increments of 2 5 with each pulse until most of the hair in the pulse zone Is disintegrated f the required reaction in the target area is observed this is the appropriate energy level to begin treatment If the required results do not appear increase the energy level according to Table 4 until the required results are observed Wait a minimum of 30 seconds between test pulses to determine the skin s reaction If the required result is not observed immediately following or within 24 hours after the test you have not yet reached the optimum level for the treatment area As you begin treatment continue to raise the energy level by increments of 5 until the required results are observed This often means raising the level above those recommended in the table If a side effect occurs at any point lower the energy level to the last used energy level that did not cause a side effect Resume treatment only after the skin has completely healed 7 3 2 The Treatment Course Refer to the Table 5 for treatment course recommendations Note Since it is strongly recommended that clients do not use any other method of hair removal while undergoing LHE treatments the SpaTouch Elite User Manual 29 CHAPTER 7 initial frequency of each treatment course takes into consideration the clients desire to be hair free previous methods of removal and hair growth cycles 7 4 Work Protocol 6 10 sessions with 4
37. tivated Figure 17 Mute Deactivated 5 9 System Fault When the word Fault appears on the Status Section of the Work Screen Figure 18 shut down the system using the main power switch on the back of the system Wait 5 minutes and then turn the system on again using the same switch If the problem persists contact an authorized Radiancy or a Radiancy technician for service Pulse Count JJ JJ JJ ute au LALLA Figure 18 Fault Indicator SpaTouch Elite User Manual 23 24 6 PRE TREATMENT 6 1 Client History During the first visit examine the areas intended for treatment and take your client s history o A complete client history includes any and all information regarding previous hair removal methods and treatments and your client s reaction to them i e is your client easily irritated by shaving has had any reactions to waxing or if their skin is generally sensitive to creams and lotions Find out if the client has a history of keloids or hypertrophic scarring Clients with a history of these conditions should be treated less aggressively Determine your client s skin s type 6 2 Side Effects Thoroughly explain to the client the treatment procedure expected results possibility of side effects and the importance of completing a full treatment course Advise the client that there may be some discomfort redness or swelling associated with the treatment There is a minimal risk of more severe side effects such
38. understand that light based treatments do not treat the underlying causes of these imbalances and can at best offer temporary cosmetic relief Please note that in some cases this treatment may stimulate excessive hair growth When treating unwanted facial hair it is crucial to correctly set the client s expectations and be very clear about anticipated outcomes The patient should be informed that the number of treatments needed for acceptable hair removal cannot be pre defined and additional maintenance treatments may be required Keep in mind that in most cases the underlying cause is unclear This hair removal treatment is cosmetic only and not a permanent solution Table 5 Treatment Course Recommendations Method Used Before LHE Treatment Course LHE Treatment Waxed once in 3 weeks Every 3 4 weeks then gradually lengthen the interval as needed after 30 regrowth occurs Tweezed every week Every 1 2 weeks for the first 1 2 months then gradually lengthen the interval to 3 4 weeks and longer as needed after 30 regrowth occurs Tweezed every day 1 2 times per week for the first 1 2 months and then gradually lengthen the interval to 2 3 weeks and longer as needed after 30 regrowth occurs 1 Maintenance Performed every 6 months as necessary 2 Early Termination Interim treatment results should be evaluated after 4 7 treatments depending on the case If the practitioner does not observe at least 30 reduction of
39. ure 8 Main Power Switch Location rrrrrnnnnrnrnnnnrvnnnnrvvnnnnrrnrnnnrennnnnrennnnnrrennnnnne 19 Figure 9 Location of On Off Button Switch rrrnnrnrnenrnnnrrrrnnnrrnrrnnnrennnnnrnnnnnrrnnnnnnne 19 Figure 10 Touch Panel and Work SCreen rarrrnnnnnnnnnnnnnnnnnnnnnnnnnnnenrnnnnennnnnnnennnnsne 20 Fure 11 WOK SEEEN Lade eee 21 Figure 12 System Readiness Wait rrrnnnnnnnnnnrnrnnnnnenrnnnnennnnnnrnnrnnnenrnnrennnnsrrnnnnnsne 22 Figure 13 System Readiness Ready rrrrrnnnnnnrnvrnnnnvnrnnnrennnnnnrnvrnnnrenrnnnennnnsrrnnnnnsne 22 Figure 14 Approaching Pulse Limit rrrnnnnnnnnnrnnnnnrnnnnnrnnnnrennnnennnrrrnnnrrnnnnnrnnnnnennnn 23 Figure 15 Pulse Limit Exceeded rrernnnnvrnnnrrnnnvvvnnnrnnnnnernnnnvnnnnnvnnnnsnnnnsnnnnnennnnnennnn 23 Fig re 16 M te Activated aan 23 Figure 17 Mute Deactivated rernnnnernnnnvrnnnvrvnnnnvnnnrnnnnnernnnnvnnnnnsnnnnsnnnnnnnnnnennnnnennnn 23 FIQGUIC AIS Faultindic ator een 23 Figure 19 Handpiece Cleaning Tool cccccccseeeceeseeeeeeeeeeeeeeueeeeeseeeeesaeeeeesaeeeees 32 Figure 20 Applying Alcohol to the Cleaning Tool rrrrrnrrrnnnnnnnnrnnnrenrnnnennnnnrennnnnne 32 Figure 21 Cleaning the Lampsauvvvs4274rr Me a ae Ree 33 Figure 22 Cleaning the Reflector cccccccccccssseeeccesseecceeeeecseseeecseseesseeseesssageees 33 Figure 23 MOES NANO ee 34 Figure 24 FUSS LOEN Henden 35 LIST OF TABLES Table 1 Technical Specifications rrr
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