POLLOGEN Intelligent Biology STOP X User Manual

A home-use device for treatment of mild to moderate facial wrinkles

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ST OP X
A HOME-USE DEVICE FOR TREATMENT
OF MILD TO MODERATE FACIAL WRINKLES
USER MANUAL
MODEL: STOP U

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Summary of Contents for POLLOGEN Intelligent Biology STOP X

  • Page 1 ST OP X A HOME-USE DEVICE FOR TREATMENT OF MILD TO MODERATE FACIAL WRINKLES USER MANUAL MODEL: STOP U...
  • Page 2: Table Of Contents

    TABLE OF CONTENTS 1. WHAT IS THE STOP X? 2 . WHO C AN BENEFIT FROM STOP X TREATMENTS? 3. CONTR AINDIC ATIONS AND SAFET Y INFORMATION • CONTR AINDICATIONS • WARNINGS • PRECAUTIONS AND SAFET Y INSTRUCTIONS • FIRE HA Z ARDS 4 .
  • Page 3 6. STOP X TREATMENT PROCEDURE • HOW OF TEN TO USE YOUR STOP X • TRE ATMENT SAFET Y GUIDELINES • FIRST TIME USE • BEFORE STARTING • HOW TO APPLY STOP PREPAR ATION GEL • HOW TO CONNECT THE POWER SUPPLY AND START THE DEVICE •...
  • Page 4: What Is The Stop

    1. WHAT IS THE STOP X? Use the STOP X at home to help reduce the appearance of mild to moderate facial wrinkles. STOP X uses a mild energy source that heats the skin and treats the wrinkles. Indications for Use: The STOP X device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV*.
  • Page 5: Who Can Benefit From Stop X Treatments

    2. WHO CAN BENEFIT FROM STOP X TREATMENTS? Adults who have mild to moderate facial wrinkles and want to decrease them using a home device. Mild Moderate Severe Wrinkles Wrinkles Wrinkles FIG.1 Who can benefit from STOP X treatments 3. CONTRAINDICATIONS AND SAFETY INFORMATION CONTRAINDICATIONS Do not use the STOP X if you have any of the following: •...
  • Page 6 cancer and use of immunosuppressive medications. • You have skin problems or irritations on your face. • You are under 21 years of age. • You are allergic to glycerin. • Suffer from autoimmune disorders or diabetes. • Currently using or used isotretinoin (Accutane) within the past six months. Using this device after using isotretinoin can cause severe scarring or more serious injury to your skin.
  • Page 7 Precaution is required before using the device if any of the following relate to you: • You use medications or cosmetic products that may cause fragile or dry skin. • You currently have or have had in the past cold sores (Herpes) or other conditions sensitive to heat.
  • Page 8: Precautions And Safety Instructions

    If in doubt about any other medical condition or medication that might affect the treatment, please consult with your physician or contact us at info@pollogen.com. PRECAUTIONS AND SAFETY INSTRUCTIONS Remember, this is an electric device using radio frequency waves.
  • Page 9: Fire Hazards

    • Do not use the device if it is damaged or an item is missing. • Turn the device on only during treatment. • Do not use the device if it is disassembled, cracked or if the electric cord is damaged. •...
  • Page 10: What's Inside The Stop X Box

    4. WHAT’S INSIDE THE STOP X BOX STOP X kit includes: • STOP X DEVICE • POWER SUPPLY • STOP PREPARATION GEL Stop Preparation STOP X Device Power Supply Stop Preparation Gel FIG.3 In the box. Check that the box includes all items.
  • Page 11 Do not use the device if it is damaged or an item is missing. Check that there is a sticker on the protective cover. If your device does not have this sticker, DO NOT USE and contact STOP X customer service at info@pollogen.com...
  • Page 12: Getting To Know Your Stop X Device

    5. GETTING TO KNOW YOUR STOP X DEVICE The STOP X device consists of a body and a protective cover. The device's body has a treatment head on one side and a control panel on the other side. TREATMENT HEAD The treatment head has four energy tips (electrodes) and a temperature sensor.
  • Page 13 1. DEVICE BODY 2. TREATMENT HEAD 3. CONTROL PANEL 4. ENERGY TIP 5. TEMPERATURE SENSOR 6. POWER SUPPLY CONNECTION 7. ON/OFF BUTTON 8. GREEN INDICATOR LIGHT 9. ORANGE INDICATOR LIGHT 10. PROTECTIVE COVER FIG.4 STOP X Device Overview. Check that the box includes all items.
  • Page 14: Power Supply

    POWER SUPPLY The power supply is equipped with a built-in electric plug adapter and power supply cord (FIG.5) Power supply Power supply cord FIG.5 Power Supply STOP PREPARATION GEL STOP preparation gel is required for use with the STOP X. After opening the container, the STOP preparation gel can be used for 12 months.
  • Page 15: Stop X Treatment Procedure

    6. STOP X TREATMENT PROCEDURE HOW OFTEN TO USE YOUR STOP X For best results, use the STOP X device 2-3 times (not consecutive days) a week for a period of 8-12 weeks. For maintenance: additional treatments are recommended once a week. TREATMENT SAFETY GUIDELINES •...
  • Page 16 2. Press the On/Off button. 3. Make sure the heating level green indicator light is on. 4. Place the device on the skin, and using slight pressure ensure that all 4 energy tips touch the skin. 5. Move the device slowly in circular motions until the orange indicator light comes on.
  • Page 17: Before Starting

    BEFORE STARTING • Remove all jewelry, piercing and eye glasses (if you wear them). • Sit in front of a mirror during treatment so you can see the orange temperature indicator light. • Clean your face with soap and water and dry thoroughly. •...
  • Page 18: How To Apply Stop Preparation Gel

    HOW TO APPLY STOP PREPARATION GEL 1. Dab a small amount of gel on your fingertip from the surface of the STOP preparation gel. 2. Dab small spots of gel around the face. Important Be careful not to apply gel into your eyes. 3.
  • Page 19: How To Connect The Power Supply And Start The Device

    HOW TO CONNECT THE POWER SUPPLY AND START THE DEVICE FIG.8 How to connect the power supply and start the device 1. Connect the power supply cord to the device. You should hear a "click" indicating that the connector is in place. 2.
  • Page 20: Treatment Procedure

    TREATMENT PROCEDURE Identify the parts of your face that you wish to treat. Divide your face into several treatment areas. Treatment time is up to 2-3 minutes for each treatment area. Total treatment session should not exceed 20 minutes. Eyelids Ears Chin / Submental Nose...
  • Page 21 5. Move the device slowly in circular motions until the orange light turns on. This indicates that the skin has reached the desired temperature. This can take 2-3 minutes. You will feel a warm sensation on your skin. (FIG.12) • During the treatment you must keep the device constantly moving.
  • Page 22 Safety feature that protects the skin from overheating The device has a safety feature that protects the skin from overheating. You will know it is activated when the orange light is on, and the green light is off. The device will turn back on when you move to the next treatment area. Immediate skin response During the treatment, your skin may become slightly red and /or swollen.
  • Page 23: Cleaning And Storage

    7. CLEANING AND STORAGE 1. Use 2-3 disposable baby wipes to remove any gel residues. 2. Use a soft cloth, moistened with detergent solution disinfectant for 5 minutes, to clean the treatment head and electrodes until they are visibly clean. 3.
  • Page 24: Troubleshooting

    8. TROUBLESHOOTING In the event that your STOP X device is not working, prior to contacting the service center, take the following precautions: 1. Make sure you have removed the device's protective cover before use. 2. Make sure the electric cord is securely connected to the device until "click"...
  • Page 25: Technical Specifications

    9. TECHNICAL SPECIFICATIONS Technical Specifications Weight: 85gr Physical Dimensions: H=134mm L=51mm W=32mm TriPollar RF Frequency: 1MHz Input: 100-240VAC 50/60 Hz 0.4A Output Voltage: DC 8V Output current: 1.5A Operating conditions Temperature: +5°C to +30°C Humidity: 20RH to 80RH Atmospheric pressure: 80 kPa to 106 kPa Transport and Storage Temperature:...
  • Page 26: Symbols And Labels Glossary

    10. SYMBOLS AND LABELS GLOSSARY Caution Consult instructions for use Batch code Catalogue number Serial number Type BF applied part (Degree and type of protection against electric shock) Date of Manufacture Manufacturer Floating Connection WEEE wheeled bin. This product contains electrical and electronic components that may contain materials which, if disposed with general waste, could be damaging to the environment.
  • Page 27: Customer Support

    You may contact Pollogen directly via: International e-mail: service@pollogen.com / Tel: +972-3-5104110 Pollogen Ltd., 6 Kaufman St., PO Box 50320, Tel Aviv 6801298 Israel 12. WARRANTY TERMS This product has been subjected to strict quality control performed by the manufacturer.
  • Page 28 its validity term, you are entitled to make use of the warranty if necessary to have a fully enjoyable product, provided the above-indicated conditions are fully met. This warranty is valid for the device marketed by the distributor in your country. The warranty is not valid when: 1.
  • Page 29: Appendix I - Wrinkle Formation

    13. APPENDIX I - WRINKLE FORMATION Collagen and elastin fibers are components in the deeper layer of the skin that give the skin its shape. The collagen fibers are responsible for skin strength and tone. The elastin fibers allow skin flexibility or elasticity. With aging, the collagen and elastin fibers weaken and the production of new fibers slows down.
  • Page 30: Appendix Ii - Clinical Trial

    14. APPENDIX II – CLINICAL TRIAL The benefits and risks of the STOP X model "STOP U" device were tested in a clinical study involving 40 participants, ages 35-65, in two sites within the United States, led by two investigators. Participants received 8 treatments by practitioners on the skin of their face for a 6 week period and there was follow up at 1 and 3 months after the last treatment.
  • Page 31: Appendix Iii - Output Power Vs. Load Resistance

    15. APPENDIX III – OUTPUT POWER VS. LOAD RESISTANCE...
  • Page 32: Appendix Iv - Electromagnetic Compatibility

    16. APPENDIX IV – ELECTROMAGNETIC COMPATIBILITY Test Standard Class / Severity lever Test result Emission (IEC 60601-1-2 sec.7) Conducted emission CISPR 11 Group 2 Class B on 230 VAC, Complies Freq. range: 150 kHz - 30 MHz 120&100 VAC mains (PA) Radiated emission Freq.
  • Page 36 TEL: +972(0)3 5104110 FAX: +972(0)3 5174112 EMAIL: INFO@POLLOGEN.COM WEBSITE: WWW.POLLOGEN.COM © POLLOGEN LTD., ALL RIGHTS RESERVED. 14700400US REV 5 DESIGN AND TECHNICAL SPECICATIONS ARE SUBJECT TO CHANGE WITHOUT PRIOR NOTICE. MANUFACTURED AND DISTRIBUTED BY POLLOGEN LTD. MADE IN CHINA. THE NAME STOP IS TRADEMARK OF POLLOGEN LTD.

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