vSculpt VS1100 User manual

USER GUIDE
MODELS: VS1100
VS1150
Register your product
at www.vsculpt.com To learn more about vSculpt treatments, accessories,
pelvic oor health, and precautions, visit vsculpt.com.
A Healthier You, Inside and Out™
0086
EC REP
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Australian Sponsor
EMERGO AUSTRALIA
Level 20, Tower II
Darling Park 201 Sussex Street Sydne
y
NSW 2000 Australia
ENGLISH

2
TABLE OF CONTENTS
1 WELCOME TO vSCULPT
– Registering Your Device
2 PRECAUTIONS
4 SAY HELLO TO vSCULPT
5 ACCESSORIES
– vSculpt Photonic Gel™
6 MEET vSCULPT
– What to Expect
– Achieving Best Results
7 FEATURES
– Modes & Settings
8 PREPARATION FOR USE
– Consulting Your Physician
– Charging
9 GETTING STARTED
– Using vSculpt
11 TREATMENT PLANS
– Therapy Plan
– Maintenance Plan
12 IMPORTANT INFORMATION
– Care, Cleaning, and Storage
13 SUPPORT
– Warranty
– Troubleshooting Guide
– Contact Information
– WEEE Waste Disposal Guidelines
– RoHS Compliant
– Technical Specications
– Glossary of Symbols
BOX CONTENTS
• vSculpt Therapeutic Device
• USB Charging Cable
• Storage Sachet
• User Guide

1
Congratulations on your purchase!
vSculpt is a handheld medical device intended for the purpose of toning,
tightening and restoring weak pelvic oor muscles and vaginal tissues for the
treatment of stress, mixed and mild to moderate urge incontinence in women.
It is also indicated to improve sexual satisfaction in women who experience
sexual dysfunction symptoms due to lack of lubrication and vaginal tissue
laxity. For the treatment of pelvic muscle pain and increased healing and blood
circulation.
vSculpt offers two models, vSculpt and vSculpt PRO. vSculpt PRO is for sale
exclusively through our professional partners. Both models are represented in
this user guide.
To accelerate the healing properties of vSculpt, we recommend use with our
Photonic Gel™ (sold separately).
It is important that you read and understand the instructions, warnings,
precautions, and safety information in this booklet before using your vSculpt for
the rst time.
*Please charge your vSculpt 12 hours prior to rst use to ensure proper
operation and battery life.
Register Your vSculpt
Register your vSculpt today at www.vSculpt.com to receive your one year
warranty and to gain access to exclusive vSculpt information, accessories, and
product news.
WELCOME TO VSCULPT

2
Please read the following safeguards before using. Please use caution and
good judgment when using vSculpt.
This Warning Symbol appears next to information about possible safety
risks. Be sure to read and follow all the warnings and safety information.
• Use this product only for its intended use as described in these directions.
• This device is not intended for use by anyone under the age of 18, and
close adult supervision is necessary if children under the age of 18 are
near the device.
This device is not waterproof and should not be submerged. It can
be cleaned with a damp cloth.
Only connect vSculpt with the USB cable provided and to USB power
adapters certied in compliance with IEC 60950-1 or IEC 60601-1 based
national standards.
No modication of this equipment is permitted.
Do not disassemble this equipment.
Do not attempt to charge device while using the device.
Mobile RF communications equipment can affect medical electrical
equipment.
• vSculpt is designed for individual use only. Please do not share.
• After each use, the device should be thoroughly cleaned.
• The device should not be used in the presence of an active sexually
transmitted infection, as an active infection may have symptoms that are
aggravated by use of the device.
• Do not use the device if you are using cancer-ghting drugs, medications,
or topical creams that increase photosensitivity. These may cause an
adverse reaction.
• This device is intended for vaginal insertion only.
• Do not use silicone-based lubricants with the device.
• Do not stare directly into the device lights.
• Do not use if you are pregnant or believe you may be pregnant.
PRECAUTIONS

3
• If you are experiencing abdominal pain, or have other medical issues or health
concerns, please consult your physician before using this device.
• If you experience numbness, skin irritation, dizziness, or feel pain, stop
using this device immediately and consult your physician.
• Exercise caution when using near body piercings.
• If you are experiencing prolonged redness or sensitivity in the treatment
area, discontinue use and consult your physician. In addition to
speaking with your physician, please contact Joylux Customer Care at
[email protected].
• If any part of the device is cracked, broken, or damaged, or if there are
signs of moisture or condensation on the inside of the device, discontinue
use immediately.
• Do not use the device if the lights have been damaged in any way.
• If the device begins to overheat, turn off immediately.
• Do not use the device if you think the device has been immersed in water.
• Do not use or store the device near water, or where it can be dropped or
pulled into water.
• Keep the USB charging cord away from children, as it poses a
strangulation risk.
• Keep the charging cord away from heated surfaces.
• Do not operate the device or charging cord if either component has been
damaged, dropped, or immersed in water, or if the cord is frayed or damaged.
• Do not disassemble. If the device is malfunctioning, contact Joylux Customer
Care at [email protected].
POTENTIAL RISKS
Please use vSculpt with caution. Inserting anything into the vagina
(including vSculpt) without proper care could result in the following:
• Cramping
• Vaginal discharge
• Vaginal infection
• Vaginal irritation
• Vaginal sensitivity

4
SAY HELLO TO VSCULPT
Therapeutic vibration
Improves muscle tone 6 or 10
modes for customization*
3 or 4 light treatment modes*
Customize your treatments USB-rechargeable
Charging is easy and
convenient
Therapeutic lights
9 red and infrared LEDs to
restore vaginal tissue and
stimulate collagen production
Gentle heat
Helps build collagen
and increase circulation Medical-grade materials
Highest grade for safety and comfort
No latex, phthalates, or BPA
* Available features depend on your specic model. See page seven for additional information.

5
ACCESSORIES
We have designed complementary products to accelerate your results.
vSculpt Photonic Gel™
vSculpt Photonic Gel is specially formulated with hyaluronic acid and aloe.
This premium water-based, ultra-concentrated gel provides lubrication and
enhances photon energy transfer to maximize the therapeutic benets of
vSculpt.
DIRECTIONS
Apply desired amount of Photonic Gel to the tip of vSculpt or to the external
genital area prior to use.
INGREDIENTS
Water/Aqua/Eau, Propylene Glycol, Hydroxyethylcellulose, PEG-45M,
Sodium Hyaluronate, Aloe Barbadensis (Aloe Vera) Leaf Juice,
Polyquaternium-5, Gluconolactone, Sodium Benzoate, Potassium Sorbate,
Citric Acid

6
MEET VSCULPT
What to Expect
vSculpt offers a noninvasive method to help restore the muscle and tissue of your
pelvic oor, improving your quality of life. To help you ease into using vSculpt,
we recommend gradually increasing the treatment modes over the course of
3 weeks—start with the beginning treatment mode (6 minutes) during the rst
week, the intermediate treatment mode (8 minutes) during the second week,
and then the advanced treatment modes of either 10 or 12 minutes beginning
in the third week.*
vSculpt provides maximum therapeutic benets through 9 high-powered LEDs
(red and infrared) to restore tissue and stimulate collagen.
*12 minute treatment option only available on vSculpt PRO
Results
For full results, we recommend you use your vSculpt every other day for 45
to 60 days or until you achieve your desired results. Upon completion of your
initial therapy, use vSculpt once per week to maintain your results.

7
FEATURES
Legend
1. On/off button
2. Light therapy mode button
3. Sonic vibration mode button
4. Indicator lights
5. Infrared treatment lights
6. Red treatment lights
7. USB charger connection
vSCULPT
SONIC VIBRATION MODES
1. Constant on- low intensity
2. Constant on- high intensity
3. Slow Wave- low intensity
4. Slow Wave- high intensity
5. Fast Wave- low intensity
6. Fast Wave- high intensity
vSCULPT PRO
SONIC VIBRATION MODES
1. Constant on- low intensity
2. Constant on- high intensity
3. Slow Wave- low intensity
4. Slow Wave- high intensity
5. Fast Wave- low intensity
6. Fast Wave- high intensity
7. Pulse- low intensity
8. Pulse- high intensity
9. Fast Pulse- low intensity
10. Fast Pulse- high intensity
At any point during therapy, vibration
can be adjusted or turned off.
At any point during therapy, treatment
lights can be turned off.
LIGHT THERAPY MODES
1. Beginning Treatment (6 minutes)
2. Intermediate Treatment (8 minutes)
3. Advanced Treatment (10 or 12 minutes)*
*12 Minute treatment option only available
on vSculpt PRO
4
2
3
6
1
5
7Sonic Vibration Modes & Settings

8
Consulting Your Physician
If you are under a doctor’s care for any pelvic oor
related conditions, please consult your physician
before using vSculpt.
Do not use if you are pregnant or believe you may
be pregnant.
Do not use if you are using cancer-ghting drugs,
medications, or topical creams that increase
photosensitivity.
Charging
Charge your vSculpt 12 hours before rst use and
subsequently after each use ensuring the battery is
fully charged.
• Attach the provided USB charging cable to the
vSculpt handle, plug into any universal USB-
certied power source, and then plug into an
electrical outlet.
• vSculpt will detect power and signal the motor
to vibrate 2 times.
• The center red indicator light will illuminate,
signifying that vSculpt is charging.
• Once the battery is fully charged, the red
indicator light will turn to solid green, indicating
the battery is fully charged.
PREPARATION FOR USE
OFF Charging Full
charge
Red Green

9
Using vSculpt
1. The therapeutic treatment lights will illuminate to
solid red and the treatment timer is activated (the
treatment program now cannot be changed).
2. Vibration will come on by default with constant low-
intensity vibration, together with therapeutic lights.
Sonic vibration mode is independent of the light
treatment; you can change the vibration pattern and
intensity at any time.
3. Insert vSculpt 4 inches into the vaginal canal.
4. vSculpt’s internal timer is immediately activated and
treatment time begins.
5. Once the treatment is completed, the therapeutic
lights and vibration will automatically turn off.
1. Apply desired amount of Photonic Gel to the tip
of the device or externally prior to insertion.
2. Turn on vSculpt by pressing the power button.
3. Choose your therapy mode of either 6, 8, 10, or
12 minutes*.
4. Press the light therapy mode button to begin
treatment.
5. Lie back and relax – knowing you are improving
your pelvic oor health.
*12 Minute treatment option only available on
vSculpt PRO
GETTING STARTED
Beginning
6
Minutes 8 Minutes 10 Minutes 12 Minutes
Intermediate Advanced
LIGHT THERAPY MODES
• Once a treatment mode has been selected,
press and hold the light therapy mode button to
activate the therapeutic treatment lights.
vSculpt PRO
vSculpt
Beginning Intermediate Advanced
6
Minutes 8 Minutes 10 Minutes

10
6. Sonic vibration modes are able to operate independently after light therapy
treatment.
7. Temperature sensors monitor heat before, during, and after light treatment
to ensure safety.
8. Though light treatments have default vibration, if you use a new sonic
vibration mode for more than 1 minute, the next light treatment will adjust
accordingly to include your preferred vibration mode.
9. After treatment time elapses, the treatment lights automatically turn off and
are disabled for 2 hours 30 minutes to ensure your safety and treatment
compliance.
10. You may continue to use vSculpt in vibration mode only while treatment
lights are disabled.
Using vSculpt in sonic vibration mode only
Using vSculpt in sonic vibration mode only
vSculpt has 6 sonic vibration modes: vSculpt PRO has 10 sonic vibration
modes:
1. Constant on- low intensity 1. Constant on- low intensity
2. Constant on- high intensity 2. Constant on- high intensity
3. Slow Wave- low intensity 3. Slow Wave- low intensity
4. Slow Wave- high intensity 4. Slow Wave- high intensity
5. Fast Wave- low intensity 5. Fast Wave- low intensity
6. Fast Wave- high intensity 6. Fast Wave- high intensity
7. Pulse- low intensity
8. Pulse- high intensity
9. Fast Pulse- low intensity
10. Fast Pulse- high intensity
• Scroll through the sonic vibration modes until desired vibration is reached.
To turn off vibration, simply press and hold the sonic vibration mode button.
• Preferred sonic vibration mode: If your selected sonic vibration mode was
used for more than 1 minute, vSculpt will store this mode in memory. The next
time vSculpt is turned on, your preferred sonic vibration mode will be initiated.
USING vSculpt (CONTINUED)
DID YOU KNOW?
Infrared light is not visible to the naked eye. vSculpt has 6 red and
3 infrared LED-emitters. When activated, only the 6 red LED-emitters will
be visible, but all 9 LED-emitters are activated.

11
Your therapeutic regimen requires use of vSculpt every other day for 45 to 60 days
or until you achieve desired results.
We recommend a gradual introduction of vSculpt therapy by increasing your
treatment duration over two weeks. This allows you time to become familiar
and comfortable with vSculpt and its many modes and settings.
WEEK 1
Beginning Treatment (6 minutes), 3 times weekly with 1 day between treatments.
WEEK 2
Intermediate Treatment (8 minutes), 3 times weekly with 1 day between
treatments.
WEEKS 3-8
Advanced Treatment (10 or 12 minutes), 3-4 times weekly with 1 day
between treatments.*
Each of us is unique. Take the time you need to adjust to the higher treatment
times. Your ramp up time may be slower or faster - both of which are ok.
*12 Minute treatment option only available on vSculpt PRO
Maintenance Plan
After you have completed your treatment plan, we recommend using your vSculpt
1-2 times weekly for 10-12 minutes.* This will help maintain your results.
vSculpt with Kegel Exercises
Kegel exercises are one way to help strengthen your pelvic oor muscles.
While vSculpt helps more than just pelvic oor muscles, when combined with
Kegels, it can amplify your results. Please see the step-by-step guide below.
1. Begin using vSculpt as directed.
2. When vSculpt is inserted into the vagina, identify the muscles you use
to stop urinating.
3. While holding the vSculpt, squeeze these muscles for up to 10
seconds, then relax for up to 10 seconds. Your stomach and thigh
muscles should not tighten when you do this.
4. Repeat as often as you can during the vSculpt light treatment. Ideally,
you should be able to do this Kegel exercise 10 to 15 times.
TREATMENT PLANS

12
IMPORTANT INFORMATION
Care, Cleaning, & Storage
vSculpt is made with body-safe,
medical-grade silicone and is easy
to clean. We recommend that you
gently clean vSculpt with water and
antibacterial soap prior to rst use
and after each subsequent use to kill
bacteria and ensure freshness.
• Make sure vSculpt is turned off.
• Do not immerse vSculpt into water,
run under water, or place in a
dishwasher, sterilizer, or autoclave.
• Use a soft nonabrasive cloth and
gentle antibacterial soap to wipe
clean.
• Soaps may cause irritation, and
any residue should be wiped off.
• Be careful to avoid the electronic
controls and charging port.
• After you clean vSculpt, let it air
dry.
• Store vSculpt in a cool, dry location,
protected from dirt, dust, and
impurities.
• Use of other cleaning solutions
and appliances may damage
vSculpt and its electronics.
• With proper care, the vSculpt
device will perform for a minimum
of two years.

13
Warranty and Product Registration
One-year warranty against manufacturer defect-related problems resulting from
normal use of the product. Register your vSculpt today at www.vSculpt.com.
Sign up for vSculpt email and gain exclusive access to vSculpt treatments,
accessories, pelvic oor health and wellness information, and new product
introductions.
Warranty Exclusions
Not covered under the one-year warranty: damage caused by misuse, abuse,
neglect, alterations, or unauthorized repair; normal wear and tear, including
chips, scratches, abrasions, discoloration, or fading.
Troubleshooting Guide
PROBLEM: vSculpt won’t turn on. Try one or more of the following:
• Make sure your vSculpt is charged. See “Charging” section of user guide.
• Make sure you are pressing and holding the On/Off button.
• If it still doesn’t turn on, contact customer care at Joylux Customer Care at
[email protected].
PROBLEM: The treatment lights won’t turn on. Try one or more of the
following:
• Make sure your vSculpt is charged. See “Charging.”
• Make sure your vSculpt is on. See above or “Get Started.”
• Make sure a treatment program has been selected. See “Get Started.”
• Press the Light Therapy Mode Button.
• If the lights still do not turn on, contact Joylux Customer Care.
SUPPORT

14
PROBLEM: The vibration won’t turn on. Try one or more of the following:
• Make sure your vSculpt is charged. See “Charging.”
• Make sure your vSculpt is ON. See above or “Get Started.”
• If using in Light Therapy Mode, make sure a treatment program has been
selected. See “Get Started.”
• If using in Sonic Vibration Mode only, press and hold the Sonic Vibration
Mode Button.
• If the vibration does not turn on, contact Joylux Customer Care.
If you continue to experience problems, please contact customer care at
[email protected].
Do not attempt to disassemble vSculpt as this may cause damage, malfunction,
electrical shock, re, or personal injury. There are no user-serviceable parts inside
the unit. If vSculpt is malfunctioning, contact customer care.
Never operate vSculpt if the USB charging cable is damaged. If vSculpt is not
working properly, or if it has been dropped, damaged, or submerged in water,
contact customer care.
Contact Information
[email protected]
www.vSculpt.com
Seattle, WA 98122
USA
About Joylux, Inc.
Joylux, Inc. is a global health technology company creating innovative
products to transform women’s pelvic oor health and empower women to live
their best lives. For more information, please visit us at www.vSculpt.com or
www.joyluxinc.com.
SUPPORT (CONTINUED)

15
Waste Electrical and Electronic Equipment Directive (WEEE)
Joylux, Inc complies with Directive 2012/19/EU OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 27 January 2003 on waste electrical
and electronic equipment (WEEE).
vSculpt contains a lithium-ion battery. This product has required the extraction
and use of natural resources for its production. It may contain hazardous
substances that could impact health and the environment if not properly
disposed of. In order to avoid the dissemination of those substances in our
environment and to diminish the pressure on natural resources, we encourage
you to use the appropriate take-back systems for product disposal. Those
systems will reuse or recycle in a sound way most of the materials of the
product you are disposing of.
The crossed-out wheeled bin symbol informs you that the product should
not be disposed of along with municipal waste and invites you to use the
appropriate separate take-back systems for product disposal.
If you need more information on the collection, reuse, and recycling systems,
please contact your local or regional waste administration.
You may also contact your retail store, supplier, or local government for more
information on the environmental performances of this product.
For instructions on how to dispose of this device, please visit
www.vSculpt.com.
RoHS Compliant
The European Union has established requirements for Restriction of Hazardous
Substances (RoHS) in all Electrical and Electronics Equipment (EEE). Please
see Directive 2011/65/EU that entered into force 21 July 2011 becoming
effective 2 January 2013.
CE Mark
vSculpt is approved in Europe as a medical device and has received the CE
mark indicating compliance with all appropriate regulations.
Federal Communications Commission Power Input (FCC)
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference,
and (2) this device must accept any interference received, including
interference that may cause undesired operation.

16
ELECTROMAGNETIC CAUTIONS
Guidance and manufacturer’s declaration – electromagnetic emissions.
The vSculpt is intended for use in the electromagnetic environment specied below.
The customer or the user of the vSculpt should assure that it is used in such environment.
Emissions Test
RF emissions (CSFPR 11)
Compliance
Group 1, Class [B]
Electromagnetic environment - guidance
The vSculpt uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic
equipment.
The vSculpt 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.
Harmonic emissions (IEC 61000-3-2) Complies (1)
Voltage uctuations/icker emissions (IEC 61000-3-3) Complies (2)
Notes: (1) The EUT utilizes less than 75W. No limits are specied for equipment with less than 75 W input rating.
(2) The EUT is unlikely to produce signicant voltage uctuations or icker. No testing required.

17
Guidance and manufacturer’s declaration-electromagnetic immunity- For all ME equipment and ME systems
The vSculpt is intended for use in the electromagnetic environment specied below.
The customer or the user of the vSculpt should assure that it is used in such an environment
Immunity Test
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Test level
± 6kV contact
± 8 kV air
Compliance level
± 6kV contact
± 8 kV air
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic title. If oors are covered
with synthetic material, the relative humidity should be at least 30%.
Electrostatic fast transient/burst
(IEC 61000-4-4)
± 2 kV power supply lines
± 1 kV for input/output lines
± 2 kV power supply lines
N/A
Mains power quality should be that of a typical commercial or hospital
environment.
Surge
(IEC 61000-4-5)
± 1 kV differential mode
± 2 kV common mode
N/A
± 2 kV common mode
Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines (IEC 61000-4-11)
<5% UT
(>95% dip in UT) for 0,5 cycle
<40% UT
(>60% dip in UT) for 5 cycles
<70% UT
(>30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
<5% UT
(>95% dip in UT) for 0,5 cycle
<40% UT
(>60% dip in UT) for 5 cycles
<70% UT
(>30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital
environment. If the user of the vSculpt requires continued operation
during power mains interruptions, it is recommended that the vSculpt
be powered from an uninterruptible power supply or a battery.
NOTE: UT is the a.c. mains voltage prior to application of the test
level.
Power frequency (50/60 Hz)
magnetic eld (IEC 61000-4-8)
3 A/m 30 A/m Power frequency magnetic elds should be at levels characteristic of
atypical location in a typical commercial or hospital environment.

18
Guidance and manufacturer’s declaration – electromagnetic immunity – for ME equipment and ME systems that are not Life-Supporting
The vSculpt is intended for use in the electromagnetic environment specied below.
The customer or the user of the vSculpt should assure that it is used in such an environment.
(See notes on following page )
Immunity Test Test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to
any part of the vSculpt including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF (IEC 61000-4-6) 3 Vrms
150 kHz to 80 MHz outside ISM bands
6 V
150 kHz to 80 MHz
Radiated RF (IEC 61000-4-3) 3 V/m
80 MHz to 2.5 GHz
10 V/m
80 MHz to 2.7 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in metres (m)(b)
Field strengths from xed RF transmitters, as determined by an electromagnetic site
survey(c) should be less than the compliance level in each frequency range(d)
Interference may occur in the vicinity of equipment marked with the following symbol: