Silkn TIGHTRA PLEIEUTSTYR FOR INTIMOMRÅDET El kitabı

Tip
El kitabı
www.silkn.eu [email protected]
Invention Works B.V.
Donk 1b, 2991 LE Barendrecht
The Netherlands
Tightra
H2400
USER MANUAL
MODE D’EMPLOI
MANUAL DEL USUARIO
MANUAL DO UTILIZADOR
ΕΓΧΕΙΡΙΔΙΟ ΧΡΗΣΤΗ
BRUKERHÅNDBOK
ANVÄNDARMANUAL
BRUGERMANUAL
BEDIENUNGSANLEITUNG
KULLANIM KILAVUZU
MANUALE PER L’UTENTE
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GEBRUIKSAANWIJZING
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Silk'n Tightra
INT/EXT
INT/EXT
#2
#4
#8
#9
#1
6
#5
#6
#3
#7
(i)
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Table of contents
1. Warnings & contraindications............................................2
2. Signs & symbols .................................................................8
3. Safety with Silk’n Tightra ...................................................9
4. Device controls & settings ................................................ 10
5. Get to know your Silk’n Tightra .......................................12
6. What to expect with Silk’n Tightra .................................. 13
7. Possible side eects ......................................................... 14
8. Treatment plan .................................................................. 15
9. Get started! ........................................................................16
10. Cleaning, maintenance & storage....................................19
11. Troubleshooting ...............................................................20
12. Consumables .....................................................................21
13. Customer service ...............................................................21
14. Warranty ............................................................................22
15. Disposal .............................................................................22
16. Specications ....................................................................23
17. Labeling ............................................................................. 24
18. Output power curves ........................................................24
19. EMC Technical results .......................................................25
20. Legal notice .......................................................................26
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1. Warnings & contraindications
A statement or event that indicates a possible or
impending danger, problem, or other unpleasant
situation when using the device.
Electricity and safety warnings
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!
UNever pull the adapter out of the socket
by the cable. Always remove it by taking
hold of the adapter.
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UDo not operate the device in environ-
ments where there is a risk of explosion.
Keep the device and all its parts away
from open ames and hot surfaces.
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.
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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.
UThe manufacturer accepts no liability for
damage or injuries caused by improper
or incorrect use.
UChildren shall not play with the device.
Cleaning and user maintenance shall not
be made by children.
UChildren must not play with the
packaging. They may injure themselves
with the packaging material, or swallow
small parts and choke.
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 15. Disposal.
Contraindications
This device including all its parts 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
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those who do not understand the hazards
involved.
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 implants 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 immunosuppressive diseases such as
AIDS and HIV, or use immunosuppressive
medications.
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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 within 2-3 weeks for non-ablative
procedures, and 6-12 weeks for ablative
fractional laser resurfacing (according to
treatment severity) prior to treatment,
except special recommendations.
Uhave used Isotretinoin (Accutane®) within
6 months prior to treatment.
Uhave a sexually transmitted disease.
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.
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Uhave any other condition which in your
physicians 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 implanted metal birth control
devices in the treatment area.
Uhave used medications, herbs, food
supplements, and vitamins known to
alter healing within the last two weeks.
Uhave a uterine prolapse, cystocele, or
rectocele.
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Uhave received drugs from your physician
for a skin condition within the past 6
months.
2. Signs & symbols
Important information about using or maintaining
the device.
Products marked with this symbol full the
requirements of the EU directives.
The device is protected against spraying water when
tilted up to an angle of 60°.
Degree of protection against electric shock: type BF
applied part.
Interference may occur in the vicinity of the
equipment.
Do not dispose with household waste! The WEEE
directive requires that you dispose of this electrical
device (including all accessories and parts) at a
designated recycling collection point for electrical
devices.
Follow the operating instructions.
Lithium battery inside.
aThis device is not suitable for use in the presence of
ammable anaesthetic mixture with air or with Oxygen or
Nitrous Oxide.
IP23
Li-ion
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3. Safety with Silk'n Tightra
With Silk’n safety comes rst. Silk'n Tightra has these safety
features:
UHeat stabilizer: To prevent overheating, each of the 16
electrodes (#5, #6) has a built-in heat stabilizer. When
a rise in the treated skin temperature is detected, the
stabilizer automatically stops emitting heat, 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 (#5, #6) when
the electrodes (#5, #6) are in good contact with the skin.
UMovement sensor: When you use the device in external
mode, the device will only emit energy when you move
the device across the skin.
UAuto shutdown: This safety feature is activated in one of
3 situations:
yYou have completed a 20 minute treatment session.
You will feel 1 vibration.
yThe device has not had rm contact with the skin for
more than 2 minutes. You will feel 1 vibration.
yThe battery is too low to complete your 20 minute
treatment session.
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4. Device controls & settings
4.1 Device modes
Silk'n Tightra has 2 operational modes: internal and external.
UInternal mode: Use this mode to tighten the vaginal tissue
and muscles to improve sexual activity. As an addition to
Kegel’s exercise, the internal mode also helps to tighten the
muscles of the pelvic oor to increase muscle tone. The
internal mode has 3 energy levels, low, regular and high.
UExternal mode: Use this mode to tighten the external
vulva skin tissue for an improved vaginal appearance. The
external mode has 1 energy level.
4.2 Device controls
Control Mode Action Explanation
Control
button
(#3)
Internal Long press Device activated (internal
mode, low energy).
The treatment mode
indicator light (#2) blinks
green; 1 vibration
Short press Regular energy
Short press again High energy
External Short press again 1 energy level only
Both
modes
Long press Device shuts down; 1
vibration
Treatment
mode
indicator light
(#2)
Internal Green (slow
blink)
Low energy
Green (fast blink ) Regular energy
Green (constant) High energy
External White (constant) 1 energy level only
Both
modes
Green and white
(alternating
blinks)
System error. The device will
auto shutdown
INT/EXT
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Control Mode Action Explanation
Battery
indicator light
(#4)
--- Green (blinks)
Green (constant)
Device charging
Device charged
Both
modes
Orange (blinks) Low charge in the battery
Orange
(constant)
No charge in the battery
4.3 Changing modes and energy levels
UInternal mode: This is the default setting when the device
is rst switched on.
UExternal mode: To change to the external mode before
you start a treatment, short press the control button (#3)
3 times. You can do this within the rst minute that the
device is on.
UChange modes during use: Once you are using the
device, you will need to shutdown the device, restart it, and
then select the mode you want.
UChange energy levels during use: To change internal
mode energy levels during a treatment, short press the
control button (#3). Each time you short press, you will
cycle through the 3 internal modes.
4.4 Device charging
Always charge the device before rst use. The initial charge
should take approximately 6 hours.
UPlace the USB cable (#8) into the device. Place the other
end of the cable into the USB adapter (#9) 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 (#4) 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. Get to know your Silk'n Tightra
5.1 Package contents
ySilk'n Tightra device yUser manual
yUSB cable & adapter* yWarranty card
ySilkn Intimate Gel yBeauty case
* Varies according to the option purchased.
5.2 Device parts
The device has a rechargeable battery which is charged using a
standard USB cable (#8). Refer to the illustration on page (i) at
the front of the manual to see the location of each feature.
USB port (#1) Electrodes - internal mode
(#5)
Treatment mode
indicator light (#2) Electrodes - external mode
(#6)
Control button (#3) Protective cover (#7)
Battery indicator light (#4) USB cable (#8)
USB adapter (#9)
5.3 Device description
Silk'n Tightra is a medical cosmetic device that uses Bi-Polar RF
Energy that ows between the electrodes (#5, #6). The Bi-Polar
RF Energy contracts and tightens the tissue internally to increase
sexual satisfaction. It also remodels the external part of the
vagina for a better, younger appearance.
5.4 Intended use
Silk'n Tightra is an electrically operated device, intended for
improved sexual functioning, or as an adjunct to Kegel’s exercise
in tightening of the muscles of the pelvic oor to increase
muscle tone.
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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.
5.5 Reading & storing the user manual
This user manual is based on the standards and rules in force
in the European Union. When abroad, you must also observe
country-specic guidelines and laws.
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.
6. What to expect with Silk'n Tightra
During a Silk'n Tightra 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.
aIf 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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CStop use immediately if you see full redness of the skin,
blistering or burns.
CStop use immediately if you have any pain, or if the skin or
the device becomes too hot.
7. Possible side effects
When used according to the instructions, side eects and
complications associated with the use of Silk'n Tightra are
uncommon. However, every cosmetic procedure, including
those designed for home use, involves some degree of risk.
Therefore, it is important that you understand and accept the
risks and complications that can occur with systems designed
for home use.
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
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.
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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.
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.
aStop use immediately if any of these eects are more
severe.
aSee your physician if the eects do not go away within 2
to 3 days.
8. Treatment plan
UEach internal or external treatment lasts for
20 minutes.
UYou may use the device in one or both
modes twice a week, for 4-5 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.
20
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9. Get started!
9.1 Before treatment
UMake sure the device battery is not low (see section 4.4
Device charging).
UEmpty the bladder before treatment.
UCheck that the gel expiry date has not passed.
URemove the protective cover (#7) that is over the
electrodes (#5, #6) before use.
UBefore use, clean the electrodes (#5, #6) with a vaginal
wipe, and dry with a clean paper towel.
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.
9.2 Internal mode treatment
1. Apply a small amount of the gel supplied with the device
to all the electrodes (#5, #6). There is no need to apply gel
internally.
2. Start internal mode treatments using the low energy
setting. Long press the control button (#3) once. You will
feel a vibration, and the device is now ready for use.
aDuring the treatment, you will feel a vibration approximately
once a minute.
3. Lie down and make yourself comfortable.
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4. Insert the electrodes (#5, #6) 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.
aIf after 5 minutes you feel comfortable with the heat, move
to the regular energy level by short pressing the control
button (#3). To use the high energy level, short press the
control button (#3) one more time.
5. Keep the device in place for 20 minutes. We recommend
that you lie still and do not move about. However, its good
to rotate the device from time to time so that the energy
keeps owing across the electrodes (#5, #6). After 20
minutes the device will auto shutdown.
6. 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.
aIn cases of pain or discomfort:
yIf you are using the high or regular energy levels,
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 the low energy level, remove
the device and wait until you feel OK before using the
device again.
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9.3 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-coloured electrodes (#5, #6). There is no
need to apply gel internally.
2. To start external mode treatments, long press the control
button (#3) and then short press it 3 times. The treatment
mode indicator light (#2) will be constant white. The
device is now ready for use.
3. Lie down and make yourself comfortable.
4. Hold the base of the device and place the 3 silver-coloured
electrodes (#5, #6) on the labia. The triangular shape of the
side with the silver-coloured electrodes (#5, #6) will help
you position the device correctly.
aWhen the electrodes (#5, #6) are in good contact with
the skin, and you are moving the device, you will feel
heat emitted from the electrodes (#5, #6). Keep moving
the device slowly but rmly across the skin. If there is no
movement, the Bi-Polar RF energy will not work.
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