POLLOGEN Intelligent Biology STOP X User manual

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

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TABLE OF CONTENTS
1. WHAT IS THE STOP X? 6
2. WHO CAN BENEFIT FROM STOP X TREATMENTS? 6
3. CONTRAINDICATIONS AND SAFETY INFORMATION 7
• CONTRAINDICATIONS 7
• WARNINGS 8
• PRECAUTIONS AND SAFETY INSTRUCTIONS 9
• FIRE HAZARDS 9
4. WHAT’S INSIDE THE STOP X BOX 10
5. GETTING TO KNOW YOUR STOP X DEVICE 11
• TREATMENT HEAD 11
• CONTROL PANEL 11
• POWER SUPPLY 12
• STOP PREPARATION GEL 12

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6. STOP X TREATMENT PROCEDURE 13
• HOW OFTEN TO USE YOUR STOP X 13
• TREATMENT SAFETY GUIDELINES 13
• FIRST TIME USE 13
• BEFORE STARTING 14
• HOW TO APPLY STOP PREPARATION GEL 14
• HOW TO CONNECT THE POWER SUPPLY AND START THE DEVICE 15
• TREATMENT PROCEDURE 16
7. CLEANING AND STORAGE 18
8. TROUBLESHOOTING 18
9. TECHNICAL SPECIFICATIONS 19
10. SYMBOLS AND LABELS GLOSSARY 20
11. CUSTOMER SUPPORT 21
12. WARRANTY TERMS 21
13. APPENDIX I – WRINKLE FORMATION 22
14. APPENDIX II – CLINICAL TRIAL 22
15. APPENDIX III – OUTPUT POWER VS. LOAD RESISTANCE 23
16. APPENDIX IV – ELECTROMAGNETIC COMPATIBILITY 24
1. WHAT IS THE STOP X? 6
2. WHO CAN BENEFIT FROM STOP X TREATMENTS? 6
3. CONTRAINDICATIONS AND SAFETY INFORMATION 7
• CONTRAINDICATIONS 7
• WARNINGS 8
• PRECAUTIONS AND SAFETY INSTRUCTIONS 9
• FIRE HAZARDS 9
4. WHAT’S INSIDE THE STOP X BOX 10
5. GETTING TO KNOW YOUR STOP X DEVICE 11
• TREATMENT HEAD 11
• CONTROL PANEL 11
• POWER SUPPLY 12
• STOP PREPARATION GEL 12

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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*.
* See section 3 for contraindications and safety information.
The STOP X device is a radio frequency (RF) device, based on the well-
established TriPollar
®
technology. The technology is based on four electrodes
designed to transmit thermal (heat) energy into the deep layers of the skin,
in order to trigger collagen remodeling that will reduce the appearance of
wrinkles and improve your skin tone and texture. TriPollar®Radio Frequency
technology combines the delivery of controlled heat deep into the skin, while
preserving the external layer - the epidermis.

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3. CONTRAINDICATIONS AND SAFETY INFORMATION
2. WHO CAN BENEFIT FROM STOP X TREATMENTS?
CONTRAINDICATIONS
Do not use the STOP X if you have any of the following:
• An implanted pacemaker, arrhythmias, or any other severe known heart
disorder. Flow of electrical energy through the body may damage the
pacemaker and cause dangerous heart arrhythmias.
• An implantable metal device or body piercing in the treatment area. Flow
of electrical energy through the implanted metal may heat the object and
cause burns.
• You currently have or have had a history of cancer or pre-cancerous moles.
• You currently have diseases such as heart problems, autoimmune disorders,
Adults who have mild to moderate facial wrinkles and want to decrease
them using a home device.
FIG.1 Who can benefit from STOP X treatments
Mild
Wrinkles
Moderate
Wrinkles
Severe
Wrinkles

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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.
• Have Fitzpatrick skin type I (light, pale white skin) or V (brown, dark brown)
or VI (very dark brown, black). The safety and effectiveness of the device
when used in individuals with pale skin (type I) or darker skin (types V or
VI) or may be prone to skin discoloration has not been established (See
Fitzpatrick Scale - FIG.2).
The Device should be used only for skin types 2,3,4.
Type 1
Light, pale
white
Always burns,
never tans
Type 2
White, fair
Usually burns,
tans with
difficulty
Type 3
Medium
white to olive
Burns mildly,
tans gradually
Type 4
Olive, mid
brown
Rarely burns,
tans with
ease
Type 5
Brown, dark
brown
Very rarely
burns, tans
very easily
Type 6
Very dark
brown, black
Never burns,
tans very
easily
FIG.2 Fitzpatrick Scale
NO NO NO YES YES YES

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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.
• You recently had any facial aesthetic procedure, such as fillers, Botox,
skin peeling or other wrinkle treatments.
Skin healing in these cases may be impaired:
• Lesions on the treatment area.
• Blood clotting disorders.
• Use of blood thinning medications.
Safety and effectiveness of the device was not tested in the following
conditions or anatomical locations; therefore, DO NOT use STOP X
under the following circumstances:
• If you have severe, deep wrinkles.
• If you are pregnant or breastfeeding.
• If you have moderate or severe wrinkles underneath the chin.
• Over the eyelids due to the potential damage to the eye structures.
• Over the eyebrows, eyeballs, lips, ears, thyroid, breasts or genital area.
• Use in subjects without total removal of facial hair may result in follicular
burn in these areas.
• Do not use the STOP X device over any areas other than the recommended
areas in this user manual (FIG.10).
• Do not use the STOP X device without the supplied treatment gel. The

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PRECAUTIONS AND SAFETY INSTRUCTIONS
Remember, this is an electric device using radio frequency waves.
Please adhere to the following precautions:
• Use this device only for its intended use as described in the user manual.
device may not operate properly if used without the STOP preparation
gel or if used with another lotion or gel.
Eye damage, damage to glands, sensitive and delicate skin and other
tissue may occur. Follow instructions for use exactly as directed for
your safety:
• The device is intended only for a single user to prevent contamination
between users.
• During treatment, in case of excessive redness or swelling, stop treatment
and cool the area using a wash cloth and cold water for at least 15 minutes.
• If redness persists for more than 24 hours after the treatment, please
consult your physician.
• Patients with visual difficulties should use the device only while wearing
corrective vision aid.
Skin injury can occur under this condition:
• Using blood thinning medications may induce skin hematomas due to
the mechanical massage by the device.
If in doubt about any other medical condition or medication that might
affect the treatment, please consult with your physician or contact us at
inf[email protected]om.

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• 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.
• Do not use the device in the vicinity of inflammable liquids (alcohol,
acetone).
• Always thoroughly dry your hands and face before treatment.
• Keep out of reach of children.
• Do not place, store or use the device near sources of water such as the
sink or bathtub.
• Do not touch the device if it is wet or falls in to water. Unplug the power
supply from the electrical outlet immediately and then take the device
out of the water. This situation could damage the device or power supply,
or cause an electric shock that may lead to serious injury or death.
• Immediately after use, or before cleaning the device, turn the device off
and unplug it from the electrical outlet.
• Only use the power supply supplied with the STOP X device. Using a
different power supply can damage the device.
FIRE HAZARDS
• Do not use the device close to explosive or highly flammable materials
(alcohol, methanol, acetone, etc.).
• If alcohol is used for cleaning the device, it must be allowed to dry
thoroughly before the device is used and then move the alcohol away
from the device.

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4. WHAT’S INSIDE THE STOP X BOX
STOP X kit includes:
• STOP X DEVICE
• POWER SUPPLY
• STOP PREPARATION GEL
FIG.3 In the box.
Check that the box includes all items.
Stop Preparation GelSTOP X Device Power Supply
Stop
Preparation
Gel