Sensica Sensifirm User manual

Table of Contents
Indications for Use 4
Intended use of Sensifirm 5
Safety 5
Sensifirm device description 6
When Sensifirm should not be used
9
9
10
11
12
12
User Instructions 13
Device Set-Up 13
Preliminary Test 14
How to use Sensifirm device 14
Recommended treatment protocol
15
16
Treatment areas
17
17
18
18
Cleaning
20
Troubleshooting
Customer Service
© All rights reserved to EL Global Trade Ltd.
3
Device Specifications
Possible Side Eects
What is Sensifirm?
How does it work?
4
4
Hand-held description
User interface description
7
8
CONTRAINDICATIONS
WARNINGS
CAUTIONS
What to expect when using Sensifirm
Post-treatment care 16
English
Electromagnetic compatibility (EMC) and Specifications
How to prepare yourself 13

English
4
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.
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
LIPOTHERM RF™ (Radio
Frequency) technology,
commonly used by professional
medical practitioners worldwide.
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 eect of the
combined RF currents and
massage activates several
biological mechanisms, among
which are collagen and elastin
remodelling and later
production, improvement in
microcirculation and in
lymphatic drainage. Together,
these eects lead to
improvement in cellulite
appearance, with the best
possible visible results, that last
for 3 months.
What is Sensifirm?
How does it work?
Introducing LIPOTHERM RF™
technology

English
Please carefully read
these Instructions for Use
before you start your
Sensifirm treatment.
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 (41o C/ 106.7o F),
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.
This guide, as well as an
instructional video, can also be
found at www.sensica.com
5

English
6
Sensifirm Device
Description
External power supply.
Sensifirm hand-held device:
•
•
Four treatment electrodes
for applying RF.
Two safety temperature
sensors, one positioned
between each pair of
electrodes.
RF energy selection button
and LED indicators for RF
intensity selection.
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 ecacy.
Base Gel ingredients: Glycerin,
Aqua, Phenoxyethanol,
Ethylhexylglycerin,
Triethanolamine and
Carbomer.
•
•
•
•
•
This Sensifirm Instructions for
Use booklet.
•
The Sensifirm kit includes the
following components:

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7
Hand-held description
Status
indicator
RF electrodes
RF energy
selection
button
1-3 energy
level lights
RF electrodes
RF electrodes
Temperature
sensors
Power
Socket

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8
Status
Indicator
Sensifirm is in standby mode
and ready to work.
Sensifirm is in treatment mode.
RF is activated, skin contact is
detected and the treatment is
underway*.
Sensifirm is in error mode. The
device has detected a
malfunction and has blocked
the activation of the RF
function.
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 o.
User interface description
*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.
RF energy
level
selection
button
Transient (for ~5
sec) orange light
followed by
transient (for ~1
sec) green light
Steady green light
Alternating red
and orange lights
1-3 energy levels
lights

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9
•
•
•
•
•
•
When Sensifirm
should not be used
Sensifirm is designed
especially for you, to allow
safe and eective 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
•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 suer 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.
•
•
Do NOT use the Sensifirm
device if any of the following
conditions apply:
•
If you suer from blood
clotting disorders, excessive
bleeding or bruising,
damaged wound healing or if
you routinely take
blood-thinning medications.
If you suer from a history of
deep vein thrombosis.
If you have a history of
collagen disorders, or suer
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 suer 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.
If you have skin cancer, areas
at risk of malignancy, or if you
have received radiation
•
•
•

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10
therapy or chemotherapy
within the past 3 months.
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
eects, please consult your
physician before using
Sensifirm.
WARNINGS
•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 aesthetic
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.
•
•
•
•
There are some scenarios in
which Sensifirm’s safety and
eectiveness has not yet been
tested or established. Therefore,
if any of the following conditions
apply, it is NOT advised that
you use the device:
•
•

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11
Use Sensifirm only with
the original power
supply. For your safety,
never use DC adapters
which are not approved
by the manufacturer.
Note: the Base Gel is for
external use only - avoid direct
contact with eyes. In the event
that such contact does occur,
wash the eyes immediately
with water.
CAUTIONS
•Never use flammable liquids,
such as alcohol (including
perfumes, sanitizers, or other
applications containing
alcohol) or acetone to clean
the skin in the hour before
using Sensifirm as it may
cause burning of the skin.
Do not open or repair the
device, as it may expose you
to dangerous electrical
components.
Do not place, store or use
Sensifirm near bathtubs,
showers, basins or other
vessels containing water,
as this may cause severe
electrocution.
Do not leave Sensifirm
unattended while plugged
into the electricity supply, as
it may lead to electrocution.
Keep out of reach of children
and pets.
Use the Sensifirm only in
accordance with these
Instructions for Use and for
the intended use.
Do not use the device if any
part of the device is missing,
damaged or loose, if the
device is not working
•
•
properly, if you see or smell
smoke, or if the device
becomes damp or wet.
Make sure the device is
clean, dry and intact before
each use. Cleaning
instructions are detailed in
the Cleaning section below
Do not use the Sensifirm
device without first applying
the Base Gel.
Do not use the Base Gel
after its expiration date.
•
•
•
In order to avoid serious harm
from using the Sensifirm device:
•
•
•
•
Note: Sensifirm is designed to
be used by a single user.

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12
Possible Side Eects
When using the Sensifirm device
according to these Instructions
for Use, side eects are rare.
However, every aesthetic
procedure, including the use of
home-use devices, may cause
side eects. Therefore, it is
important that you understand
and accept the risks and
complications that can occur
when using an RF cellulite
appearance reduction device:
What to expect
when using Sensifirm
If necessary, please consult
with your physician if any of
these side eects occur.
Degree
of Side
Eects
Side Eects
Minor
Rare
Extremely
Rare
Local pain
Skin irritation
Skin redness
Minor swelling
Skin sensitivity
Allergies or sensitivity
to Base Gel
Mild skin burns
Pigment changes
Excessive redness,
rash, swelling
Subcutaneous
bleeding
Severe burns
Infection
Bruising
Blistering
The use of the Sensifirm device
is simple and quick, as
detailed in the User
Instructions section below.
The Sensifirm treatment
session may cause:
Sensations of warmth,
created by the RF energy
and the massage.
Some mild red or pink color
on the skin, during and just
after the treatment session.
•
•

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13
User instructions
Sensifirm is intended for use on
buttocks and thighs.
Device Set-Up
Remove all components
from the box (the Sensifirm
device, power supply and
Base Gel).
Check the expiration date of
the Base Gel.
Before beginning the
treatment, make sure that
the electrodes are clean, dry
and intact.
Insert the plug end into an
electrical outlet, and insert
the cord end into the device
socket.
Your Sensifirm device is
now ready for use.
1.
2.
3.
4.
How to prepare yourself
1.
2.
3.
4.
Prepare the treatment area.
Make sure your skin is dry,
clean and free of topical
products, such as
moisturizers and lotions.
Caution: Never use
flammable liquids, such as
alcohol (including perfumes,
sanitizers, or other
applications containing
alcohol or acetone) to clean
the skin in the hour before
using Sensifirm, as it may
cause burning of the skin.
Remove all jewelry from the
treatment area.
Remove excessive or long
hair from the treatment area.
Perform a preliminary test on
a small patch of skin in the
intended treatment area, 48
hours before the first use of
Sensifirm. In the preliminary
test, you can determine the
energy level settings that
best suit you (see Preliminary
test section).

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14
Preliminary Test
How to use Sensifirm device
The preliminary test is intended
to determine how your skin will
react to the Sensifirm treatment,
and to help you to find the most
comfortable setting for you, for
each treatment area.
Perform a preliminary test on
each area you intend to treat
48 hours before the first full
treatment.
Apply a thin, even layer of
the Base Gel included in your
kit, on the area that is
intended for treatment.
Set the RF energy level to
the level you found most
comfortable when you
carried out the preliminary
test. Press the RF energy
level selection button
1.
2.
Apply a thin, even layer of
Base Gel, included in your kit,
on the treatment area.
Plug in the Sensifirm device
and select RF energy level 3.
Place the Sensifirm device on
the desired treatment area
and move it in a circular
motion, for 3 minutes.
The treatment will create a
warm sensation on your skin.
However, if you feel your skin
is heating up too fast, reduce
the RF energy level, adjusting
it to suit your own comfort.
Stop the test immediately if
you do not feel comfortable,
or if you see adverse eects
such as severe redness or
blistering.
Wait 48 hours and examine
the tested area.
1.
2.
3.
4.
5.
6.
If the skin in the test area
seems normal (no adverse
eects) you can proceed with
a full treatment at the highest
comfortable energy level.
Note: The RF energy level indicates
the rate at which the temperature
rises when in heating mode. A high
RF energy level will enable you
faster and more even heating.
We recommend performing all
treatments at energy level 3
(highest). However, you can
achieve maximum results at all RF
energy levels: at lower levels, it will
just take longer to reach the
eective temperature.
Note: A preliminary test should be
conducted before proceeding to
a full treatment. (See Preliminary
test section above.
See treatment areas, treatment
time and treatments schedule in
the Recommended treatment
protocol section below.
7.

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15
repeatedly until you reach
the desired level: 1, 2, or 3.
Place the devices on the
intended treatment area,
ensuring full contact of all 4
electrodes with your skin
throughout the entire
treatment. If the device is not
properly placed, the RF energy
and massage will not be
delivered. When the device is
working, you will feel and hear
a gentle vibration, and the
indicator will be lit up in green.
Move the device over the
treatment area in slow
circular motions, while
maintaining constant, firm
contact with the skin.
If you do not feel a sensation
of warmth after approximately
30 seconds, try moving the
Sensifirm over a smaller
treatment area, and/or
increasing the RF energy.
At the end of each treatment
session, turn o the device by
pressing on the energy
selection button. An orange
indicator light will light up
while the device is shutting
down. After the light has
turned o, unplug the device
from the electrical outlet.
After completing the
treatment, wipe o any
remaining Base Gel from the
treated area.
3.
4.
5.
6.
7.
8. Clean the device with a soft
damp cloth or paper towel,
according to the cleaning
instructions in the Cleaning
section below.
Recommended treatment
protocol
For long-lasting results, use
Sensifirm once a week on each
treatment area, for a period of
8 weeks.
To sustain optimal results, you
can repeat the Sensifirm
treatment protocol as needed.
You can use the Sensifirm
device on buttocks and thighs.
A typical treatment session
takes about 20 minutes for a
body area that is 15cmX30cm
(6inX12in) in size - about the
size of your two palms.
We recommend performing all
treatments at energy level 3
(the highest). However, you
can achieve maximum results
at all RF energy levels: at lower
levels, it will just take longer to
reach the eective
temperature. Therefore, select
your RF energy level
according to your own level of
comfort, as determined by
you during the preliminary test.
•
•

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16
Treatment areas
Buttocks and thighs
(cellulite treatment)
•Place the treatment
electrodes on the treatment
area, as indicated in the
diagram.
Move the Sensifirm in
continuous circular motions
around the area, as
indicated by the arrows in
the diagram.
The recommended
treatment time for this area
is 20 minutes for each side.
•
•
Note: The way the body
responds to the Sensifirm
treatment diers between
individuals, depending on
environmental and biological
factors, heredity and age.
Do not treat full areas with
energy levels you have not
tested before (as detailed in the
Preliminary test section above).
Note: For your own comfort, it is
recommended to perform the
treatments of all areas while
lying down.
Post-treatment care
•After completing the
treatment, wipe o the
remaining Base Gel from the
treated area.
Do not expose the treatment
area to direct sun light
without applying a
high-factor sunscreen (at
least 30 SPF). Uncontrolled
sun exposure might cause
your skin to be sensitive
For 2 days after treatment,
avoid the use of extremely
hot water and do not use
abrasive or harsh products.
In cases where superficial
crusting or scabbing occurs,
do not rub, scratch or
remove the scab. Cleanse
the area gently and pat dry.
Since skin cellulite formation
is an ongoing process, you
may repeat the Sensifirm
treatment according to your
needs.
•
•
•
•

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17
•If Sensifirm does not turn on:
Cleaning
Make sure to turn o and
unplug the device before
cleaning.
It is recommended to use a
soft damp cloth, paper towel
or pre-moistened wipe to
clean any residual Base Gel
from the Sensifirm. Make sure
the entire underside of the
device, including the
electrodes area, temperature
sensors and plastic cover, is
cleaned thoroughly.
1.
2.
Do not rinse the Sensifirm
device under running
water, as this may cause
device malfunction.
Keep the Sensifirm device
dry. Never place, store or use
your Sensifirm near bathtubs,
showers, basins or other
vessels containing water, as
this may cause electrocution.
If you do not plan on using
your Sensifirm device for a
long period of time, it is
recommended to keep it clean
and stored in its original box.
If you plan to travel and take
your Sensifirm with you, you
should store it in the original
box and follow the
maintenance instructions.
3.
4.
5.
Troubleshooting
If you experience any
problems with your Sensifirm,
please refer to the information
below:
Make sure that the power
cord is plugged in properly
to the electrical outlet and
into the device socket.
Make sure that the power
outlet has power.
a.
b.
•If Sensifirm does not deliver
RF signal energy and
massage (i.e. you cannot feel
the warm sensation or hear/
feel the gentle vibration):
Make sure there is full
contact of the electrodes
with the skin
Make sure that the Base
Gel has been applied
properly over the
treatment area.
The RF signal will be
activated only when at
least 2 of the electrodes
(the front pair or rear pair)
are in full contact with the
skin. (See indicator details
set out in the User interface
description section above.
a.
b.
c.

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18
•General error:
If dirt or debris get stuck on
the electrodes, you should
clean them in accordance
with the Cleaning section
above. If you cannot get
the area clean, contact
our customer service.
In case of a general error,
reset the device – unplug
the power cord from the
electrical outlet on the wall,
wait 10 seconds and then
reconnect it.
If you still have problems
with your device, please
contact our customer
service.
a.
b.
c.
Costumer Service
For more information about
Sensifirm, if your Sensifirm is
broken or stops working, if
you need assistance or if you
would like to order more
Base Gel (for additional
treatments or if your Base
Gel has expired), please
contact us:
•
855-SENSICA
(855-736-7422)
[e-mail]
Device specification
parameters
The RF handheld device is
powered by multipolar RF at
10±1 Watt
Frequency: 1±0.05 MHz
Selectable output power level:
3 levels
Temperature sensors: RF
heating is automatically
deactivated when skin
temperature reaches 41oC
(106.70F). The heating is
reactivated when
temperature decreases.
Treatment area: ~20cm2(
~3.25 in²)
External power supply:
Input 100-240VAC, 50-60Hz,
0.5A
Output 12VDC, 1.8A
Device size:
146mm X 74mm X 63mm
(LxHxW)
5.75in X 2.91in X 2.48in (LxHxW)
Weight:
192g (6.77oz)

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19
Use Sensifirm only with
original power supply.
For your safety, never
use DC adapters which
are not approved by
the manufacturer.
Storage Instructions
Storage and Transport
Conditions
Temperature
Humidity
Non-condensingPressure
Operational Conditions
Temperature
30% to 70% RHHumidity
10,000 ft.
Max
Operating
Altitude
-10 0C to 70 0C
(140F to 1580F)
10% to 90% RH
at 550C/1310F
100C to 400C
(500F to 1040F)
Labeling
Model: CEL100xxyyzzz
Power: 9V, 1.5A, 100-240VAC,
50-60Hz
Double insulation
Consult Instructions
for use
Do not dispose
Please read all warnings
and safety precautions
prior to use
Keep dry
Type BF equipment
Do not use the Sensifirm
device on sensitive
tanned skin or after sun
exposure
Interference may occur
in the vicinity of
equipment
MD 04195 A1

20
English
The FCC Wants You
to Know:
This equipment has been
tested and found to comply
the limits of ISM device,
pursuant to Part 18 of the FCC
rules. These limits are
designed to provide
reasonable protection against
harmful interference in a
residential insulation. This
equipment generates, uses
and can radiated radio
frequency energy and, if not
installed and used
accordance with the
instructions, may cause
harmful interference to radio
communication. However,
there is no guarantee that
interference will not occur in a
particular installation. If this
equipment does cause
harmful interference to radio
or television reception, which
can be determined by turning
the equipment o and on, the
user is encourage to try to
correct the interference by
one or more of the following
measures:
a. Reorient or relocate the
receiving antenna.
b. Increase the separation
between the equipment and
receiver.
c. Connect the equipment to
an outlet on a circuit dierent
from that to witch the
receiver is connected.
d. Consult the dealer or an
experienced radio/TV
technician.
Modifications not expressly
approved by the manufacturer
could void the user authority to
operate the equipment under
FCC Rules.
FCC Warning

21
Electromagnetic
compatibility (EMC)
and Specifications
•The Sensifirm requires that
special precautions are
taken regarding EMC, and
must be installed and put
into service according to the
EMC information provided.
Portable and mobile RF
communications equipment
can aect Sensifirm.
Portable RF communications
equipment, including
antennas (including
peripherals such as antenna
cables and external
antennas) should be used no
closer than 30cm (12 inches)
to any part of the Sensifirm,
including cables specified by
the manufacturer. Otherwise,
degradation of the
performance of this
equipment could result
The use of accessories or
replacement parts, other
than those sold/specified by
Sensica International, may
result in increased emissions
or decreased immunity of
the Sensifirm.
The Sensifirm should not be
used adjacent to or stacked
with other equipment. If this
•
•
•
•
is unavoidable, the Sensifirm
should be observed to verify
normal operation in the
configuration in which it will
be used.
English

22
IEC 60601-1-2: 2014 4th Edition
The Sensifirm is intended for use in the electromagnetic environment
specified below. The customer or the user of the Sensifirm should
assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment –
guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Group 1
Class B
Class A
Complies
The Sensifirm emits
electromagnetic energy in order
to perform its intended function.
Nearby electronic equipment
may be aected.
The Sensifirm is suitable for use in
all establishments, including
domestic establishments and
those directly connected to the
public low voltage power supply
network that supplies buildings
used for domestic purposes.
EMC Information
English