Silk'n Tightra H2401 User manual

Tightra
H2401
USER MANUAL
EN

Silk'n Tightra
INT/EXT
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(i)

Table of contents
1. Warnings .............................................................................2
2. Contraindications ...............................................................4
3. Safety features ....................................................................7
4. Get to know your device.....................................................7
4.1 Device description ..................................................................................................7
4.2 Intended use ..............................................................................................................8
4.3 Package contents.....................................................................................................8
4.4 Device parts.................................................................................................................8
4.5 Device controls..........................................................................................................9
4.6 Device shutdown.................................................................................................. 10
4.7 Treatment modes..................................................................................................10
4.8 Energy levels ............................................................................................................11
4.9 Device charging.....................................................................................................11
5. Treatments ........................................................................12
5.1 Treatment plan .......................................................................................................12
5.2 What to expect with the device ..................................................................12
5.3 Possible side eects............................................................................................. 13
6. Get started!........................................................................14
6.1 Pre-treatment..........................................................................................................14
6.2 Internal mode treatment..................................................................................15
6.3 External mode treatment ...............................................................................16
6.4 After treatment....................................................................................................... 18
7. Cleaning, maintenance & storage....................................19
8. Troubleshooting ...............................................................19
9. Customer service...............................................................20
10. Consumables.....................................................................20
11. Warranty ............................................................................21
12. Disposal ............................................................................21
12.1 Packaging...................................................................................................................21
12.2 Battery removal......................................................................................................21
12.3 Device ......................................................................................................................... 22
13. Specications ....................................................................23
14. Signs & symbols ...............................................................24
15. Labeling ............................................................................25
16. Output power curves........................................................26
17. EMC Technical results .......................................................27
18. Legal notice .......................................................................28
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1. Warnings
Before rst use, please read this user manual in
full, and keep it for future use. We recommend
you refamiliarise yourself with the instructions
before each treatment.
UKeep the device, USB cable and adapter dry
at all times.
UDo not use the device while bathing or
taking a shower.
UAlways ensure that your hands are dry
before connecting the device to the
electricity supply.
UNever use the adapter if it has a damaged
cable or plug, or isn’t working properly,
or has been submerged in water. If that
happens, unplug the adapter immediately
before touching it. Failure to unplug the
adapter may result in an electric shock!
UDo not operate the device in environments
where there is a risk of explosion. Keep the
device and all its parts away from open
ames and hot surfaces.
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UKeep the adapter accessible at all times, so it
can be removed from the electricity supply
easily in case of emergency.
UDisconnect the device from the electricity
supply after charging.
UNever pull the adapter out of the socket by
the cable. Always remove it by taking hold
of the adapter.
UPlace the adapter cable in such a way that it
does not pose a tripping hazard.
UDo not use if the parts or accessories
are not supplied by the manufacturer as
dened in this manual, or if the device
is damaged or does not appear to be
working properly. In such cases contact
Customer Service.
UEnsure there are no unintended rough
surfaces, sharp edges or protrusions which
may cause harm before each use.
UDo not attempt to modify, open or repair
the device. You may expose yourself to
dangerous electrical components and may
cause serious harm to yourself. It will also
void the warranty.
UChildren shall not play with the device.
Cleaning and user maintenance shall not
be made by children.
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UChildren must not play with the packaging.
They may injure themselves with the
packaging material, or swallow small parts
and choke.
UThis unit has been designed and tested to
meet the requirements of electromagnetic,
electrostatic, and radio frequency
interference standards. However, the
possibility of electromagnetic or other
interference may still exist. Relocating the
device may help to eliminate interference.
UIf your device reaches its end of life stage,
take the device and all its parts to a recycling
point designed for electrical devices. Refer
to section 12. Disposal.
2. Contraindications
This device including all its parts is suitable for women aged 18
and above who wish to improve the rming and tightening of
pelvic oor organs, reduce stress urinary incontinence, or vaginal
symptoms.
The device must not be used by the following people: children,
transgender women, adults with limited physical, sensory
or psychological capacities, or those lacking experience or
knowledge in how to use the device in a safe way, or those who
do not understand the hazards involved.
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[Do not use if you:
Uare pregnant or nursing.
Uhave had any surgical procedure in the vaginal or pelvic
area within the last 12 months, or before complete healing.
Uhave an active electrical implant/device in any region of
the body, a pacemaker or internal debrillator.
Uhave a metal implant, including a metal intrauterine device
(IUD), in the treatment area.
Uhave severe concurrent conditions, such as cardiac
disorders, sensory disturbances, epilepsy, uncontrolled
hypertension, liver or kidney diseases.
Uhave a history of skin cancer and genital area cancer,
or current condition of any other type of cancer, or pre-
malignant moles.
Uhave an impaired immune system due to immuno-
suppressive diseases such as AIDS and HIV, or use
immunosuppressive medications.
Uhave poorly controlled endocrine disorders, such as
diabetes, or thyroid dysfunction and hormonal virilization.
Uhave any active condition in the treatment area, such as
sores, psoriasis, eczema, rashes, open lacerations, abrasions,
or lesions.
Uhave received treatment with light, laser, RF, or other devices
in the treated area for either non-ablative procedures, or
ablative fractional laser resurfacing (according to treatment
severity) within 3 months prior to treatment.
Uhave used Isotretinoin (Accutane®) within 6 months prior
to treatment.
Uhave a sexually transmitted disease.
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Uhave a current urinary tract infection, pelvic or pelvic tract
infection.
Uhave received radiation therapy or chemotherapy
treatments within the past 3 months.
Ucannot sense heat properly because of an illness, or other
health related issue.
Uare menstruating.
Uhave any other condition which in your physician’s opinion
would make it unsafe for you to use the device.
[Consult your physician before use if you:
Uhave received an abnormal result from a PAP smear or
pelvic exam within the last 2 years.
Uhave a history of diseases stimulated by heat, such as
recurrent Herpes Simplex, in the treatment area.
Uhave had vaginal surgery, or you have been told you have
a vaginal prolapse.
Uhave a history of skin disorders, keloids, abnormal wound
healing, as well as very dry and fragile skin.
Uhave a history of bleeding coagulopathies, or use of
anticoagulants except for low-dose aspirin.
Uhave an implanted mesh.
Uhave a non-metal intrauterine device (IUD).
Uhave used medications, herbs, food supplements, and
vitamins known to alter healing in the treatment area
within the last two weeks.
Uhave a uterine prolapse, cystocele, or rectocele.
Uhave received drugs from your physician for a skin condition
within the past 6 months.
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Uhave uterine broids (myomas), endometrial or uterine
polyps, or any other abnormal condition in the uterus or
cervix.
3. Safety features
With Silk'n safety comes rst. The device has these safety features:
UHeat stabilizer: To prevent overheating, each of the 16
electrodes (#6), (#7) has a built-in heat stabilizer. When
a rise in the treated skin temperature is detected, the
stabilizer automatically stops emitting RF energy, until
the skin temperature lowers enough for the stabilizer to
resume heating.
UTouch sensor: The touch sensor ensures that the RF Energy
will only pass through the electrodes (#6), (#7) when the
electrodes (#6), (#7) are in good contact with the skin.
UMovement sensor: When you use the device in external
mode, the device will only emit RF Energy when you move
the device across the skin.
4. Get to know your device
4.1 Device description
The device uses Bi-Polar RF Energy that ows between the
electrodes (#6), (#7). The Bi-Polar RF energy works to promote
the formation and reconstruction of vaginal collagen and
elastin bers.
The device has LED lights to indicate dierent energy levels and
treatment modes. It has a rechargeable battery which is charged
using a type C USB cable (#9).
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Refer to the illustration on page (i) at the front of the manual to
see the location of each feature.
4.2 Intended use
This electric device is intended to improve the rming
and tightening of pelvic oor organs, reduce stress urinary
incontinence or vaginal symptoms, and improve sexual
functioning.
The device is intended for self-treatment only, and is not suitable
for commercial or therapeutic use. Do not use for any purpose
other than as described in this manual.
4.3 Package contents
yThe device yUser manual
yUSB cable & adapter yWarranty card
ySilk'n Intimate Gel yStorage case
4.4 Device parts
yUSB port (#1) yElectrodes -
internal mode (#6)
yBattery indicator light (#2) yElectrodes -
external mode (#7)
yControl button (#3) yProtective cover (#8)
yTreatment mode
indicator light (#4))
yUSB cable - type C (#9)
yEnergy level indicator
lights (#5)
yUSB adapter (#10)
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4.5 Device controls
Control Action Description
Control
button
(#3)
Long press yDevice activated - internal mode,
energy level 1 (low); treatment mode
indicator light (#4) is o (no light)
yOnce active, long press shuts the device
down; 1 vibration.
Short press x1 Internal mode - energy level 2
(medium)
Short press x2 Internal mode - energy level 3 (high).
Short press x3 External mode - energy level 1 (low);
treatment mode indicator light (#4) is
on (white constant)
Short press x4 External mode - energy level 2
(medium)
Short press x5 External mode - energy level 3 (high)
Treatment
mode
indicator
light (#4)
O: no light Internal mode
On:
white constant
External mode
On:
white blinks
There is a system error. The light blinks
and alternates with blinking energy
level indicator lights (#5)
Control Action Description
Energy level
indicator
lights (#5)
1
3
2
Green - constant 1 light - level 1 (low)
2 lights - level 2 (medium)
3 lights - level 3 (high)
Green - blinks There is a system error. The lights
blink and alternate with the blinking
treatment mode indicator light (#4)
1
3
2
1
3
2
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Control Action Description
Battery
indicator
light (#2)
Green - blinks
Green - constant
Orange - blinks
Orange - constant
Device charging
Device charged
Low charge in battery
No charge in battery, treatment mode
inactive
4.6 Device shutdown
The device shuts down in one of 3 situations:
UYou have completed a 20 minute treatment session.
UThe device has not had rm contact with the skin for more
than 2 minutes.
UThe battery is too low.
ZThere is one vibration when the device shuts down.
4.7 Treatment modes
The device has 2 treatment modes: internal and external.
UInternal mode: Use this mode to tighten the vaginal
tissue and muscles of the pelvic floor to increase muscle
tone and reduce incontinence.
UExternal mode: Use this mode to tighten the external
vulva skin tissue for an improved vaginal appearance.

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UTo change treatment modes: Turn off the device and
then turn it on. To access the mode you want, see step 2 in
sections 6.2 Internal mode treatment or 6.3 External mode
treatment).
4.8 Energy levels
UEach treatment mode has 3 energy levels: level 1 (low),
level 2 (medium), level 3 (high). In general, the higher the
energy level, the better the results.
UEach treatment mode starts at energy level 1.
UTo change the energy level: Cycle through the energy
levels by short pressing the control button (#3) until you
get the level you want.
4.9 Device charging
Always charge the device before rst
use. The initial charge should take
approximately 6 hours.
UPlace the USB cable (#9) into
the device. Place the other end
of the cable into the USB adapter (#10) and connect to
the electricity supply. The battery and treatment mode
indicator lights (#4),(#2) will go on and o, and then the
battery indicator light (#2) will blink green.
URecharge the device fully after each 20 minute treatment,
and check the battery level before you start a new
treatment.
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5. Treatments
5.1 Treatment plan
UEach internal or external treatment lasts for
20 minutes.
UUse the device in one or both modes 2 or 3
times a week for 4 weeks.
UAfter that, reduce the use gradually to once
a week, then to every 2 weeks or less frequently, to meet
your specic needs.
5.2 What to expect with the device
During a treatment session it is normal to experience and feel:
UA sensation of heat: both during internal and external
treatments.
USome redness or slight swelling of the skin: This may
occur around the vagina following an external treatment.
These reactions should last no more than 24 hours.
ZIf you experience these reactions, we recommend that you
apply aloe vera gel on the aected skin.
UA short vibration: During a treatment, you will feel a
vibration every few minutes. This is normal, and indicates
that the device is active.
UTemporary increase in incontinency: When using the
internal mode, some users might experience the need
to pass water more frequently. Don’t worry, this will go
away in a few days. The eects of incontinency will start
to reduce, and you will see an improvement as a result of
the treatments.
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[Stop use immediately if you see full redness of the skin,
blistering or burns.
[Stop use immediately if you have any pain, or if the skin or
the device becomes too hot.
5.3 Possible side eects
When used according to the instructions, side eects and
complications associated with the use of the device are
uncommon. Below are some recommendations should you
experience any of the possible side eects.
Minor discomfort
(Internal/external modes)
Some users may feel mild discomfort
during use. This is best described
as a mild stinging sensation on the
skin around the vagina. The stinging
sensation may last during or after
treatment.
Recommendation:
Use a lower energy level and wait
until you have no discomfort
before your next treatment.
Excessive heat sensation
(Internal /external modes)
If you have pain, severe discomfort or
a very unpleasant feeling, reduce the
energy level until you feel OK.
Recommendation:
Use a lower energy level and wait
until the eect has cleared before
your next treatment.
Allergic reaction
(Internal /external modes)
In rare cases, you may experience an
allergic reaction after the treatment.
Recommendation:
Stop treatment, and consult your
physician if the reaction remains for
more than 24 hours.
Excessive redness and swelling
(External mode)
In rare cases, the skin around the
vagina may become very red and
swollen. The redness and swelling
should subside within 2 to 5 days.
Recommendation:
Treat with frequent applications
of aloe vera cream. Wait until the
eect has cleared before your next
treatment. Consult your physician
if the redness does not go away
within 5 days.
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Blisters or burns
(External mode)
In very rare cases, you may
experience some blistering or
burning of the skin around the
vagina.
Recommendation:
Cool the aected area and apply
anti-burn cream. Wait until the
eect has cleared before your next
treatment and use a lower energy
level.
Consult your physician if the skin
does not return to normal within
a week.
Spotting
(Internal mode)
In rare cases, you may experience
slight spotting immediately after a
treatment.
Recommendation:
Consult your physician if the eect
continues for more than 24 hours.
[Stop use immediately if any of these eects are more
severe.
[See your physician if the eects do not go away within 2
to 3 days.
6. Get started!
6.1 Pre-treatment
UMake sure the device battery is not low (see section 4.9
Device charging).
UEmpty the bladder before treatment.
UCheck that the gel expiry date has not passed.
URemove the protective cover (#8) that is over the electrodes
(#6), (#7) before use.
UBefore use, clean the electrodes (#6), (#7) with a vaginal
wipe, and dry with a clean paper towel.
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UNever use ammable liquids such as alcohol (including
perfumes, sanitizers, or other applications containing
alcohol), or acetone to clean the skin before use.
URemove all piercing or metal from the treatment area
before use.
6.2 Internal mode treatment
1. Apply a small amount of the gel supplied with the device
to all the electrodes (#6), (#7). There is no need to apply
gel internally.
2. For internal mode treatments, turn on the device by long
pressing the control button (#3). The internal mode will
be active, and the device will be set to energy level 1. The
treatment mode indicator light (#4) will be off (no light).
You will feel a vibration and the device is ready for use.
3. Lie down and make yourself comfortable. Start your
treatment at energy level 1.
4. Insert the electrodes (#6), (#7) into the vagina as far as is
comfortable for you. When the device is inside the vagina
you need to make sure that the device is supported during
treatments:
yIf your legs are splayed out on the bed, close your legs
slightly to hold the device in place.
yIf you lie with your legs bent (and feet on the bed),
place a cushion under the device to hold the device
in place.
yYou might also wish to hold the device, if you nd that
helps to keep the device in place.
ZDuring the treatment, you will feel a vibration approximately
once a minute.
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5. If after 5 minutes you feel comfortable with the heat, move
to energy level 2 by short pressing the control button (#3).
To use energy level 3 (high), short press the control button
(#3) one more time.
6. Keep the device in place for 20 minutes. We recommend
that you lie still and do not move about. However, it’s good
to rotate the device from time to time so that the energy
keeps owing across the electrodes (#6), (#7). After 20
minutes the device will shutdown.
ZIn cases of pain or discomfort:
yIf you are using energy levels 2 or 3, reduce the energy
by pressing the control button (#3) 1 or 2 times. Wait
5 minutes for the heat to reduce.
yIf you are already using energy level 1, remove the
device and wait until you feel OK before using the
device again.
7. At the end of the treatment, remove the device, and wipe
the external skin around the vagina with a clean dry towel,
or wipes specically for the vaginal area, to remove any gel
residue.
8. Clean the device (see section 7. Cleaning, maintenance &
storage).
6.3 External mode treatment
Before use, the skin should be shaven, clean, dry and free of any
powders, antiperspirants or deodorants. Also, be sure that the
skin is not red or inamed.
1. Apply a small amount of the gel supplied with the device
to the 3 silver-colored electrodes (#6), (#7).There is no
need to apply gel internally.
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2. For external mode treatments, turn on the device by long
pressing the control button (#3), then short press it 3
times. The external mode will be active, and the device will
be set to energy level 1. The treatment mode indicator light
(#4) will be on (constant white). You will feel a vibration
and the device is ready for use.
3. Lie down and make yourself comfortable. Start your
treatment at energy level 1.
4. Hold the base of the device and place the 3 silver-colored
electrodes (#6), (#7) on the labia. The triangular shape of
the side with the silver-colored electrodes (#6), (#7) will
help you position the device correctly.
5. When the electrodes (#6), (#7) are in good contact with
the skin, and you are moving the device, you will feel
heat emitted from the electrodes (#6), (#7). Keep moving
the device slowly but rmly across the skin. If there is no
movement, the Bi-Polar RF energy will not work.
ZDuring the treatment, you will feel a vibration approximately
once a minute.
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6. If after 5 minutes you feel comfortable with the heat, move
to energy level 2 by short pressing the control button (#3).
To use energy level 3 (high), short press the control button
(#3) one more time.
ZIf the energy level is right for you but it feels too hot now
and again, increase the area you are treating and/or keep
moving the device around the treatment area.
ZIf you nd it dicult to move the device across the skin,
you may apply another small amount of gel on the 3 silver-
colored electrodes (#6), (#7) ).
7. Continue to glide the device across the labia. After 20
minutes the device will shutdown.
ZIn cases of pain or discomfort: remove the device, and wait
until you feel OK before using the device again.
8. At the end of the treatment, remove the device, and wipe
the external skin around the vagina with a clean dry towel,
or wipes specically for the vaginal area, to remove any gel
residue.
9. Clean the device (see section 7. Cleaning, maintenance &
storage).
6.4 After treatment
After internal or external mode treatments, we recommend
that you:
Uavoid very hot water for 2 days after the treatment.
Ucontact your physician if there is any indication of infection,
excessive swelling, redness, pain, or any other unusual
symptom.
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