El Global Trade SENSILIFTST100 User Manual
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
Authorization
Name
Title
Signature
Date issued
Updated by:
Veronika Kravtsov
RA/ QA
Associate
June 6th, 2017
Reviewed by:
Martin Gurovich
VP R&D
June 6th, 2017
sensiLift
INSTRUCTIONS FOR USE
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EL Global Trade Ltd.
sensiLift p-1
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
Revision
Paragraph
Change Description
Date
Issued by
A0
All
Initial release
January 12th, 2014
Segman Shlomit
B0
Cleaning
Maintenance title
was added as
headline
June 12th, 2014
Shlomit Segman
FCC
declaration
added
FCC warnings
added
C0
All
According to FDA
requirements,
comments from FDA
pre-submission and
Dr. Man review
Oct 14th, 2014
Segman Shlomit
D0
All
Updating treatment
times according to
clinical trial results
Jan 10th, 2016
Yael Liebes-Peer
Recommended
treatment
Addition of
maintenance protocol
E0
All
According to FDA
comments (Q160059)
and Prof. Shemer
Review
Oct 31st, 2016
Yael Liebes-Peer
F0
All
According to FDA
comments (K17499):
Addition of indication
for use statement,
restriction to use near
the eyes and on
thyroid, clearer
language, removal of
“unique” sensor
description
April 18th, 2017
Yael Liebes-Peer
List of Revisions
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EL Global Trade Ltd.
sensiLift p-2
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
G0
All
According to FDA
comments
(K170499/S001)
June 6th, 2017
Veronika Kravtsov
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EL Global Trade Ltd.
sensiLift p-3
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
© All rights reserved to EL Global Trade Ltd.
Table of Contents
What is sensiLift ................................................................................................................. 6
Indications for Use: .................................................................................................... 6
How does it work? ..................................................................................................... 6
Who should use and how to decide to use sensiLift ............................................................... 7
With sensiLift, your safety is in good hands! .......................................................................... 8
sensiLift Device Description ................................................................................................. 8
Hand-held description ............................................................................................... 9
User interface description ........................................................................................ 10
When shouldn’t sensiLift be used? ..................................................................................... 11
Who cannot use the sensiLift
- CONTRAINDICATIONS ............................................... 11
What you must do to avoid serious harm – WARNINGS ............................................. 12
What you must do to avoid other harm - CAUTIONS: ................................................. 13
Possible Side Effects ......................................................................................................... 14
Benefits .......................................................................................................................... 15
User Instructions .............................................................................................................. 16
Device Set-Up .......................................................................................................... 16
How to prepare yourself .......................................................................................... 16
Preliminary Test ...................................................................................................... 17
How to Use the sensiLift device ................................................................................ 18
Recommended treatment protocol: ................................................................................... 19
Typical sensiLift Treatment Interval ......................................................................... 19
Treatment Areas ...................................................................................................... 19
What to expect when using sensiLift ......................................................................... 20
Post facial treatment care ......................................................................................... 21
Cleaning and troubleshooting ............................................................................................ 21
Cleaning .................................................................................................................. 21
Troubleshooting ................................................................................................ ...... 22
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EL Global Trade Ltd.
sensiLift p-4
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
Customer Service ............................................................................................................. 23
Device Specification Parameters ........................................................................................ 24
Storage Instructions ......................................................................................................... 24
Labeling .......................................................................................................................... 25
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EL Global Trade Ltd.
sensiLift p-5
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
What is sensiLift
sensiLift is a home use device intended for non-invasive treatment of mild to moderate
facial wrinkles and rhytides.
sensiLift brings a completely new approach to non-invasive skin treatment using
Dynamic RF™ technology combining RF (Radio Frequency) used by doctors
professionals worldwide with the comfort of moving treatment fingers.
Indications for Use:
The sensiLift is an over-the-counter home use device intended for non-invasive
treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin
Types I-IV.
How does it work?
Introducing the new Dynamic RF technology
A major cause of skin wrinkles is the reduction in the quantity and quality of collagen
fibers in the dermis and hypodermis (skin layers).
Radio Frequency (RF) is a form of electromagnetic energy. RF energy is being used in
doctors’ clinics for a long time. RF treatments were found to produce a highly efficient
thermal effect on biological tissue. Heat is generated as a result of tissue resistance to the
movement of electrons within the RF field. The sub-cutaneous heat generates new
collagen and enhances existing collagen, leading to wrinkles reduction.
The sensiLift
TM
treatment creates enough thermal effect to induce collagen remodeling
with no ablative thermal damage of the epidermis or dermis.
The sensiLift device is based on the unique Dynamic RF™ technology. The unique
technology combines RF with moving treatment fingers. This maximizes the
effectiveness and safety of the RF treatment, allowing multiple RF waves to reach wider
range of skin layers and assist in getting best possible visible and ongoing, lasting
results.
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EL Global Trade Ltd.
sensiLift p-6
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
Please carefully read this user manual before you start using
sensiLift
TM
.
Who should use and how to decide to use sensiLift
sensiLiftTM is intended for women, 30-70 years old who desire to reduce mild to
moderate facial wrinkles and rhytides.
sensiLiftTM is intended for use on the cheeks, around mouth, the “crow’s feet”
next to your eyes, and the chin (as also demonstrated in the “treatment area”
section.
sensiLiftTM is intended for use on Fitzpatrick skin type I-IV, as demonstrated
below:
Note: sensiLift is especially designed for your own personal treatment! It is intended for a
single user only.
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EL Global Trade Ltd.
sensiLift p-7
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
sensiLift's safety
sensiLift has two built in thermal sensors, constantly measuring your skin temperature.
When the temperature rises to the maximal allowed (104oF), the RF energy will
automatically stop. When temperature is low enough, the RF energy will be automatically
re-activated.
In addition, the RF electrodes constantly move. This prevents local over-heating of your
skin.
No over-heating due to the temperature sensors and the movement of the treatment
fingers. Altogether, follow the instructions for use and your treatment will be comfortable
and pleasant.
sensiLift Device Description
The sensiLift device kit has the following main components:
1) External power supply
2) sensiLift hand-held device:
Two treatment fingers including the electrodes applying RF while moving.
The treatment fingers also include safety temperature sensors.
3) sensiLift Base:
Specially designed to improve contact between the device and the skin and
enhance skin conductivity.
sensiLift Base ingredients: Glycerin, Aqua, Phenoxyethanol,
Ethylhexylglycerin, Triethanolamine and Carbomer.
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EL Global Trade Ltd.
sensiLift p-8
EL Global Trade Ltd
Tzoran 8
th
St, P.O.Box 8242, Netanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiLift
RD-11118 B1
Hand-held description
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EL Global Trade Ltd.
sensiLift p-9
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