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SYSTEM DESCRIPTION

12 Revision 02, January 2011

2.7. 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 60335-1; 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.

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Содержание SpaTouch Elite

Страница 1: ...User Manual January 2011 Revision 02...

Страница 2: ......

Страница 3: ...cturer 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 Tervuren 34 Bt...

Страница 4: ...ith the Touch Panel Screen 19 5 3 Emitting a Pulse 21 5 4 Adjusting Energy Level 22 5 5 About Ready Mode 22 5 6 System Shut Down 22 5 7 Alerts 23 5 8 Mute 23 5 9 System Fault 23 6 Pre Treatment 24 6 1...

Страница 5: ...ystem Readiness Ready 22 Figure 14 Approaching Pulse Limit 23 Figure 15 Pulse Limit Exceeded 23 Figure 16 Mute Activated 23 Figure 17 Mute Deactivated 23 Figure 18 Fault Indicator 23 Figure 19 Handpie...

Страница 6: ...s 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 sen...

Страница 7: ...iece 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 t...

Страница 8: ...cations 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 Eli...

Страница 9: ...the entire system It includes the following major parts Front View Operation Panel Display Screen On Switch Handpiece Cradle Figure 2 Front View of Console Panel Right Side View Handpiece power and a...

Страница 10: ...E 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 Figure 5 Handpiece 2 1 3 Footswitch The footswitch arrives connected to...

Страница 11: ...m2 Spot Size 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...

Страница 12: ...internal and independent safety electronic circuit shuts down pulse flashing ability in the event of a disabled blower 2 4 Major Precautions Warnings 2 4 1 Precautions Verify that SpaTouch Elite s nom...

Страница 13: ...o treatment Never use flammable substances or harsh chemicals to clean or disinfect any part of the SpaTouch Elite system Always make sure to completely lift the Handpiece off the client s skin betwee...

Страница 14: ...e 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 Pigment...

Страница 15: ...psy 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...

Страница 16: ...ion consult accompanying documents before use Attention consult accompanying documents before use Manufacturer Authorized representitive in the European community Degree of protection against electric...

Страница 17: ...s and usage warnings Table 3 Additional Labels Label Location and Comments Located on the back of the system this label includes manufacturer details voltage information and the system s serial number...

Страница 18: ...EN 55014 1 EN 55014 2 EN 61000 3 2 EN 61000 3 3 Harmonized Standards EN 60335 1 EN 60335 2 27 Household and similar electrical appliances Part 1 EU Directives Low Voltage Directive 2006 95 EC Electrom...

Страница 19: ...ty 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 SpaT...

Страница 20: ...nd 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 t...

Страница 21: ...iece s are connected Plug the system into a designated electrical outlet Test the system for proper operation When not in use always make sure the handpiece is in its cradle Do not drop the handpiece...

Страница 22: ...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 ind...

Страница 23: ...he 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 crustin...

Страница 24: ...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 Reevalu...

Страница 25: ...on button Figure 9 Location of On Off Button Switch 5 2 Working with the Touch Panel Screen SpaTouch Elite s intuitive touch panel is designed to guide you through the entire treatment process It is...

Страница 26: ...etween Ready and Wait modes Set Button sets energy level after adjusting it with buttons Button increases or decreases the energy level Reset button resets both the Time and Pulse Count Mute button tu...

Страница 27: ...e device s readiness to emit a pulse Wait or Ready Right Treatment Section This section tracks pulses and time for each treatment It displays o the elapsed time of current treatment o the number of em...

Страница 28: ...rgy level using the buttons Press the Set button to confirm energy level selection Press the Start Stop button to enter Ready mode 5 5 About Ready Mode SpaTouch Elite will only emit pulses during the...

Страница 29: ...ress the Mute Button to turn off the sound Figure 10 When the system is in mute mode the word Mute will appear on the Status Section of the Work Screen Figure 16 System Fault Press the Mute Button aga...

Страница 30: ...ermine 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 treatmen...

Страница 31: ...manufacturer s instructions 6 5 Pre Treatment Preparations 6 5 1 Determining the Client s Skin Type To evaluate client s skin type use the Fitzpatrick Skin Type Classification scale FITZPATRICK SKIN...

Страница 32: ...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...

Страница 33: ...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 a...

Страница 34: ...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 surfac...

Страница 35: ...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 poi...

Страница 36: ...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...

Страница 37: ...l treatment is cosmetic only and not a permanent solution Table 5 Treatment Course Recommendations 1 Maintenance Performed every 6 months as necessary 2 Early Termination Interim treatment results sho...

Страница 38: ...tor 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 Figure 19 Handp...

Страница 39: ...n 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 be...

Страница 40: ...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...

Страница 41: ...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 ba...

Страница 42: ...tton to turn it to off The Footswitch was not pressed Simultaneously press the Footswitch and Handpiece pulse switch The main unit has not completed the recharging cycle Wait for the steady Square Rea...

Страница 43: ...e fan Shut down the system using the power switch on the back of the system Wait 5 minutes and then restart the machine If nothing is blocking the fan and the problem persists shut down the system and...

Страница 44: ...he system Contact Radiancy or a Radiancy authorized technician F2 Blower communication fault Shut down the system using the power switch on the back of the system Contact Radiancy or a Radiancy author...

Страница 45: ...d 5 Hanagar St P O Box 7329 Hod Hasharon 45240 ISRAEL Tel 972 9 775 7500 Fax 972 9 775 7511 service radiancy com Radiancy North America Radiancy Inc 40 Ramland Road South Suite 200 Orangeburg NY 10962...

Страница 46: ...ence 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 da...

Страница 47: ...irst time the adverse effect was observed mm dd yy _____ _____ ___ Date the adverse effect resolved mm dd yy _______ _______ _______ Please describe in detail the event or problem If there is not enou...

Страница 48: ...________________________________________________ ____________________________________________________________ Please include any other relevant client history including any preexisting medical conditi...

Страница 49: ...Ltd 5 Hanagar St P O Box 7329 Hod Hasharon 45240 Israel SpaTouch Elite Warranty Card User Information System Details Name Serial Number Street Purchase Date City Comments State Zip Code Tel Fax Mobile...

Страница 50: ......

Страница 51: ......

Страница 52: ...ad South Suite 200 Orangeburg New York 10962 USA Tel 1 845 398 1647 Fax 1 845 398 1648 Toll Free 1 888 661 2220 RADIANCY INC RADIANCY LTD 2010 2011 Radiancy Inc All Rights Reserved 2026120 Rev 02 Janu...

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