El Global Trade SENSIFIRM User Manual
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
Sensifirm Instructions for Use - US
RD 12004 E1
Page 1 of 28
Authorization
Name
Title
Signature
Date issued
Updated by:
Veronika Kravtsov
RA/ QA
Associate
Dec 28th, 2017
Approved by:
Yael Liebes-Peer, PhD
RA/ QA
Manager
Dec 28th, 2017
Sensifirm
Instructions for Use - US
This document and the information contained in it are proprietary and confidential to EL Global Ltd. and associates. Nothing herein may be copied,
reproduced or distributed in any form or any medium, or disclosed to any third party in any manner without prior written authorization of EL Global
Ltd.
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 2 of 28
Revision
Paragraph
Change Description
Date
Issued by
A0
All
Initial release according to
discussions with Prof. Avner
Shemer
February
21st, 2016
Veronika
Kravtsov
B0
All
Sections re-organization,
Wording and re-phrasing
December
13th, 2016
Veronika
Kravtsov
Contraindications,
warnings and
cautions
Re-organized
Electromagnetic
compatibility
(EMC) and
Specifications
Section was added
B1
Electromagnetic
compatibility
(EMC) and
Specifications
Updating information
according to external lab
certification
Jan 26th,
2017
Veronika
Kravtsov
All
Correction of typos (removal
of “touch” from “touch
button” and replacing
“treatment fingers” with
“electrodes”
C0
All
According to FDA comments
(K170637): Addition of
indication for use statement,
clearer language, removal of
“unique” sensor description
May 7th,
2016
Veronika
Kravtsov
D0
All
According to FDA comments
(K170637/S001)
July 13th,
2017
Veronika
Kravtsov
D1
All
Typos correction and editing by
“copy”
Nov 20th,
2017
Veronika
Kravtsov
Labeling
Updating symbols
E0
FCC
Section was added
Dec 28th,
2017
Veronika
Kravtsov
E1
FCC
According to FCC COMMENTS
regarding the Bluetooth
Module, added in the FCC
section: “Device contain FCC ID:
2ACCRMC10”
July 19th
2018
Eitan Blaich
List of Revisions
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 3 of 28
© All rights reserved to EL Global Trade Ltd.
Table of Contents
Indications for Use ........................................................................................................................... 4
What is Sensifirm? ........................................................................................................................... 4
How does it work? ........................................................................................................................... 4
Intended use of Sensifirm ............................................................................................................... 5
Safety ............................................................................................................................................... 5
Sensifirm device description ........................................................................................................... 6
Hand-held description ................................................................................................................ 7
User interface description .......................................................................................................... 7
When Sensifirm should not be used ............................................................................................... 8
CONTRAINDICATIONS ................................................................................................................... 8
WARNINGS .................................................................................................................................. 9
CAUTIONS .................................................................................................................................. 10
Possible side effects ...................................................................................................................... 11
What to expect when using Sensifirm ........................................................................................... 11
User instructions ........................................................................................................................... 12
Device set-up .............................................................................................................................. 12
Preliminary test ........................................................................................................................ 13
How to use the Sensifirm device .............................................................................................. 14
Recommended treatment protocol ......................................................................................... 15
Treatment areas ........................................................................................................................ 15
Post-treatment care .................................................................................................................. 16
Cleaning ......................................................................................................................................... 16
Troubleshooting ............................................................................................................................ 17
Customer service ........................................................................................................................... 18
Device specifications ..................................................................................................................... 19
Electromagnetic compatibility (EMC) and Specifications.............................................................. 21
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 4 of 28
Indications for Use
The Sensifirm device is intended to achieve the following result, using non-thermal radiofrequency
combined with massage: temporary reduction in the appearance of cellulite.
What is Sensifirm?
Sensifirm is a home-use device used for the temporary reduction in the appearance of cellulite.
The treatment is applicable to areas of the body where cellulite occurs: the buttocks and thighs.
Sensifirm brings a completely new approach to non-invasive and non-ablative treatment, featuring
Sensica LIPO RF™ (Radio Frequency) technology, commonly used by professional medical
practitioners worldwide.
How does it work?
Introducing LIPO RF™ technology
The Sensifirm device combines the advantages of localized heating produced by radiofrequency
energy, together with a massage achieved by a vibration motor and manual manipulation.
The massage. Massage therapy is known to be useful for various applications, including improving
cellulite appearance. The Sensifirm houses a vibration motor, which causes a gentle massage
sensation as you move the device over your skin.
RF technology. Radio Frequency (RF) is a form of electromagnetic energy that has been used for a
long time in aesthetic medicine. The spacing between Sensifirm’s four RF electrodes enables great
treatment volume and allows multiple RF waves to reach deep into the skin layers, heating the
dermis, hypodermis (inner skin layers) and subcutaneous fat layers, without damaging the
epidermis (outer skin layer).
The deep thermal effect of the combined RF currents and massage activates several biological
mechanisms, among which are collagen and elastin remodeling and later production,
improvement in microcirculation and in lymphatic drainage. Together, these effects lead to
improvement in cellulite appearance, with the best possible visible results, that last for 3 months.
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 5 of 28
Please carefully read these Instructions for Use before you start your
Sensifirm treatment. This guide, as well as an instructional video, can also be found at
www.sensica.com
Intended use of Sensifirm
Sensifirm is intended for use by women who want to improve cellulite appearance in the
treatment area.
Sensifirm is especially designed for use on the buttocks and thighs, where cellulite tends
to appear.
Note: Sensifirm is especially designed for your own personal treatment, and is intended for a
single user.
Safety
Sensifirm is designed to protect your skin. The device has two built-in sensors, which constantly
measure your skin temperature. When the temperature rises to the maximal level (41oC/ 106.7oF),
the RF energy (heat) will automatically stop. When the temperature has decreased again, the RF
energy (heat) will be automatically re-activated.
The temperature sensors prevent local over-heating. Follow these Instructions for Use for a
comfortable and pleasant treatment experience.
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 6 of 28
Sensifirm device description
The Sensifirm kit includes the following components:
External power supply.
Sensifirm hand-held device:
o Four treatment electrodes for applying RF.
o Two safety temperature sensors, one positioned between each pair of
electrodes.
o RF energy selection button and LED indicators for RF intensity selection.
o LED to indicate the device status (ON/OFF).
Base Gel:
Designed specifically to improve contact between the device and the skin, and
to improve skin conductivity, to ensure proper delivery of RF energy and best
possible results.
DO NOT use Sensifirm without first applying the Base Gel, as this will
compromise your safety and treatment efficacy.
Base Gel ingredients: Glycerin, Aqua, Phenoxyethanol, Ethylhexylglycerin,
Triethanolamine and Carbomer.
This Sensifirm Instructions for Use booklet.
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 7 of 28
Status indicator
Transient (for ~5 sec) orange
light followed by transient (for
~1 sec) green light
Sensifirm is in standby mode and ready to
work.
Steady green light
Sensifirm is in treatment mode. RF is
activated, skin contact is detected and the
treatment is underway*.
Alternating red and orange
lights
Sensifirm is in error mode. The device has
detected a malfunction and has blocked
the activation of the RF function.
RF energy level
selection button
1-3 energy levels lights
The green light indicates which RF energy
level has been activated. Press the RF
energy level selection button repeatedly
until you reach the desired level: 1, 2, 3, or
off.
Note: RF energy is delivered only when proper contact with your skin is detected. When proper
treatment is underway, the status indicator will have a steady green light and you will feel vibration.
* Upon contacting the treatment area, the massage function is automatically turned on.
Hand-held description
User interface description
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 8 of 28
When Sensifirm should not be used
Sensifirm is designed especially for you, to allow safe and effective treatment. However,
Sensifirm may not be appropriate for everyone. Please read the information below before
use. If you still have any doubts, and you are unsure whether Sensifirm is safe for your
use, please consult your physician.
CONTRAINDICATIONS
Do NOT use the Sensifirm device if any of the following conditions apply:
• If you have an active implant, such as a pacemaker or insulin pump, or if you have any
known severe heart disorder, such as arrhythmias.
• If you are pregnant or breastfeeding.
• If you suffer from severe or uncontrolled endocrine or metabolic conditions, such as
diabetes or uncontrolled thyroid disease.
• If you have a damaged immune system or autoimmune disorder, such as AIDS or Lupus,
or if you use drugs that influence the immune system.
• If you suffer from blood clotting disorders, excessive bleeding or bruising, damaged
wound healing or if you routinely take blood-thinning medications.
• If you suffer from a history of deep vein thrombosis.
• If you have a history of collagen disorders, or suffer from keloid scarring (growth of
extra scar tissue where the skin has healed after an injury).
• If you have a general extreme illness, such as hepatitis, liver disease or epilepsy.
• If you suffer from sensitive or damaged skin such as in cases of frequent redness or
rash, inflammations, breakouts (such as psoriasis), blisters, sores, infections, acne or
extra dry skin.
• If you have diminished or exaggerated perception of temperature change.
• If you have taken Accutane in the past 6 months.
• If you have a heat-induced disease or an active skin disease, such as herpes, eczema,
rashes etc., in the treatment area.
EL Global Trade Ltd
Tzoran 8th St, P.O.Box 8242, Natanya 4250608, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831
sensiFirm Instructions for Use - US
RD 12004 E0
Page 9 of 28
• If you have skin cancer, areas at risk of malignancy, or if you have received radiation
therapy or chemotherapy within the past 3 months.
WARNINGS
There are some scenarios in which Sensifirm’s safety and effectiveness has not yet been tested or
established. Therefore, if any of the following conditions apply, it is NOT advised that you use the
device:
• If you have any permanent implants in the designated treatment area, including but
not limited to: silicon or injected chemical materials, metal plates or other metal
materials.
• If in the past 3 months you have had surgery, including plastic surgery, or you have
undergone any esthetic procedure, such as skin resurfacing, liposuction, deep peeling,
cryolipolysis (fat freezing), or have had esthetic injections of fillers, such as hyaluronic
acid, collagen, fat or Botox, in the treatment area.
• If you have any metal items, such as jewelry or piercings, or tattoos or permanent
make up on the designated treatment areas.
• If you have sunburn, or dark brown or black spots such as freckles, birth marks, moles
or blisters in the treatment area.
• If you are allergic or sensitive to chrome or nickel or any component of the Base Gel.
• If you are male.
• If you are under the age of 18.
• If you have reduced physical, sensory or mental capabilities.
• Do not use Sensifirm over breasts, genitals or areas not recommended in Instructions
for Use guide.
• Do not use Sensifirm over hairy areas of the body, as this may result in the hairs being
burnt.
Note: If you have undergone any other aesthetic procedure in the designated treatment area, or if
you have treated the skin with a prescribed drug within the past 3 months, or if you have any
concerns regarding potential side effects, please consult your physician before using Sensifirm.
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