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Radiancy SpaTouch Elite User Manual

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User Manual
January 2011, Revision 02

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Summary of Contents for Radiancy SpaTouch Elite

  • Page 1 User Manual January 2011, Revision 02...
  • Page 3 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.

  • Page 4: Table Of Contents

    3. Initial Set up 3.1. Unpacking SpaTouch Elite................13 3.2. Electrical Requirements................. 13 3.3. Installation......................14 4. General Guidelines for the Operation of SpaTouch Elite 5. Operation 5.1. Turning on the System................... 19 5.2. Working with the Touch Panel & Screen ............ 19 5.3.
  • Page 5 IST OF IGURES Figure 1: SpaTouch Elite Main System ..............2 Figure 2: Front View of Console & Panel..............3 Figure 3: Handpiece Connections ................3 Figure 4: Back Panel....................4 Figure 5: Handpiece....................4 Figure 6: Footswitch....................5 Figure 7: Handpiece Connection ................14 Figure 8: Main Power Switch Location ..............

  • Page 6: Glossary Of Terms

    LOSSARY OF ERMS 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.

  • Page 7: Introduction To The System

    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.

  • Page 8: System Description

    YSTEM ESCRIPTION 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.

  • Page 9: Figure 2: Front View Of Console & Panel

    Operation Panel, Display Screen, On Switch, Handpiece Cradle Handpiece Cradle Display Screen Operation Panel Figure 2: Front View of Console & Panel Right Side View:  Handpiece power and air connections HP connections Figure 3: Handpiece Connections SpaTouch Elite User Manual...

  • Page 10: Figure 4: Back Panel

    SYSTEM DESCRIPTION Back View:  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 Air Exhaust Port Footswitch Port Figure 4: Back Panel 2.1.2.

  • Page 11: Technical Information

    43 cm x 43 x 22 cm / 16.93 x 16.93 x 8.66 in. (w/d/h) Weight 7 kg.; 15.43 lbs . Electrical Requirements Single phase 100-240VAC, 50/60Hz, 6.3A, 50-60 Hz Operation Conditions Temperature 5º-30º C Humidity 30%-80% RH Transport & Storage Temperature -20º- 80º C Humidity 0%-95% RH; 0.1-1.5 atm. SpaTouch Elite User Manual...

  • Page 12: Safety Features

    SYSTEM DESCRIPTION 2.3. Safety Features Many features were built in to the SpaTouch Elite to help insure the safety of 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.
  • Page 13  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 between pulses in order to avoid excessive heating of the handpiece or skin.

  • Page 14: Contraindications

    (abnormal) pigmented lesion should be covered with a non- flammable white sticker. 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.
  • Page 15 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...

  • Page 16: Labels

    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...

  • Page 17: Table 3: Additional Labels

    Located on the back of the system this label includes manufacturer details, voltage information, and the system’s serial number. Handpiece label located on the SpaTouch Elite handpiece. On rear panel. On rear panel. This warning appears on all handpieces, next to opening. SpaTouch Elite User Manual...

  • Page 18: Compliance With International Standards

    SYSTEM DESCRIPTION 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 –...

  • Page 19: Initial Set Up

    (according to the local line voltage):  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.

  • Page 20: Installation

    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.
  • Page 21 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. This may cause damage to the lamp and handpiece. SpaTouch Elite User Manual...

  • Page 22: General Guidelines For The Operation Of Spatouch Elite

    UIDELINES FOR THE PERATION OF OUCH LITE The general guidelines below are relevant for all SpaTouch 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 ...
  • Page 23 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...
  • Page 24 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.

  • Page 25: Operation

    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 recommended to read this section carefully and to become completely familiar with the user-interface before beginning treatment.

  • Page 26: Figure 10: Touch Panel And Work Screen

    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. Revision 02, January 2011...

  • Page 27: Emitting A Pulse

    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...

  • Page 28: Adjusting Energy Level

    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 Ready Mode. The Ready Mode is indicated by two methods.  An audible signal. ...

  • Page 29: Alerts

    (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.

  • Page 30: Pre-Treatment

    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.

  • Page 31: Informed Consent Form

    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...
  • Page 32 CHAPTER 6  If 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 III 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.

  • Page 33: Post Treatment Care

    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...

  • Page 34: Treatment Protocols

    IMPORTANT: When treating skin types V-VI, 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.
  • Page 35 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...

  • Page 36: Work Protocol

    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 4-8 weeks between each session.  Set the initial energy level according to test results. ...

  • Page 37: Table 5: Treatment Course Recommendations

    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 hair they should consider, together with the patient, the possibility of early termination. SpaTouch Elite User Manual...

  • Page 38: Maintenance

    AINTENANCE 8.1. Cleaning Instructions Caution:  Before cleaning the handpiece and main unit, always turn the unit off, disconnect it from energy and wait a minimum of 5 minutes.  Do not use cleaning solutions that contain ingredients that may harm plastic, such as ammonia, acetone, hydrochloric acid (HCI), chlorine bleach etc.

  • Page 39: Figure 21: Cleaning The Lamps

     Avoid getting cleaning solution into the machine. Spray the solution directly onto the cloth and not onto the unit itself. SpaTouch Elite User Manual...

  • Page 40: Parts & Attachments

    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.

  • Page 41: Figure 24: Fuse Location

    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 Power Cord Inlet Figure 24: Fuse Location SpaTouch Elite User Manual...

  • Page 42: Troubleshooting

    Replace If over 20,000 pulses. Improper locking of lamp into Handpiece Stop system operation. Call caused darkening of Radiancy service immediately contact points The cooling air-flow is Rupture in the Replace the Handpiece weak Handpiece spiral tube...

  • Page 43: System Errors

    Shut down the system using the power switch on the back of the system. Charging fault Contact Radiancy or a Radiancy authorized technician.  Make sure you are using the SpaTouch Elite Unrecognized handpiece (and not a Mistral or Kona handpiece handpiece) ...
  • Page 44  If the 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 Handpiece the back of the system.

  • Page 45: Spatouch Elite Service

    5 Hanagar St., P.O. Box 7329 Fax: 972-9-775-7511 Hod Hasharon, 45240, ISRAEL service@radiancy.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...

  • Page 46: Adverse Events Report Form

    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.
  • Page 47 Please describe in detail the event or problem. If there is not enough room, continue on other paper and attach to report. ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ ____________________________________________________________ Treatment discontinued? If yes, provide an explanation for discontinuation: ____________________________________________________________ ____________________________________________________________ SpaTouch Elite User Manual...
  • Page 48 ____________________________________________________________ ____________________________________________________________ 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: Event Outcome: Probable Resolved Possible Improved...

  • Page 49: Warranty

    13. W ARRANTY After 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:...
  • Page 52 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.

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