SKIN CLINICAL REVERSE User manual

User & Product Guide

1. Press the on/off button to power-on.
quick start guide
Please make sure SKINCLINICAL®reverse is fully charged before proceeding with these steps. To
fully charge the device, attach the USB wall mount charger and plug it into the power outlet until
“Charge Status” indicator on the bottom of the product changes from flashing BLUE color to solid
BLUE color. Disconnect charger for treatment.
2. The blue and green lights on the handle
will illuminate and the LED lens will glow
red, indicating the device is ready for use.
3. Place the device lens in contact with your
skin and glide along treatment area until it
beeps (3 minutes). Repeat for each treatment
area.
4. Press the on/off button to power-off.

table of contents
Introduction .....................................................................................1
Indications for Use ..........................................................................2
Product Benefits..............................................................................2
Product Overview.............................................................................3
Sensitivity Test .................................................................................6
Treatment Protocol .........................................................................7
Precautions......................................................................................8
Product Risks .................................................................................9
Product Care and Maintenance .....................................................9
Product Disposal ...........................................................................10
Labeling .........................................................................................11
Troubleshooting.............................................................................12
Guidelines for Troubleshooting..................................................... 12
Warranty ........................................................................................14
Declaration of Conformity.............................................................15
Warnings........................................................................................16

introduction
Congratulations on selecting SKINCLINICAL®reverse for your skincare
regimen. SKINCLINICAL reverse is a battery-operated, handheld, light-
emitting diode (LED) device for the treatment of fine line facial wrinkles.
SKINCLINICAL reverse emits gentle doses of red and infrared light leading
to a reduction of these wrinkles.
Please refer to the treatment protocol for additional information about
treatment of fine line facial wrinkles. Before using SKINCLINICAL reverse,
please review this manual in its entirety for the important information it
provides.
Dermatologists and clinicians worldwide have been using LED emitting
clinical devices for many years to treat fine line wrinkles with great
success.
During the natural aging process, we lose appreciable levels of collagen
which is the major supporting protein of the skin’s cellular structure. As
we age, this collagen depletion causes our skin to become more fragile,
less able to maintain moisture and as a result thereof, less flexible. Thus
begins the dreaded wrinkling process and the loss of that “bright eyed
vibrance” we enjoyed when we were young.
The sun’s ultraviolet rays do more than just provide a nice sun tan.
These UV rays damage our skin’s supportive structure which inhibits the
production of new collagen. The lack of sufficient replenishing collagen
leads to fine lines and wrinkles.
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indications for use
SKINCLINICAL reverse is an Over The Counter (OTC) handheld device
intended for use in the treatment of full face wrinkles.
product benefits
SKINCLINICAL reverse LED therapy works with the body’s own natural
processes to reduce the appearance of facial wrinkles.
The SKINCLINICAL reverse system consists of Medical Grade ABS Plastic,
ergonomic handheld treatment unit and a separate wall mounted Lithium
Polymer battery charger with a standard micro USB connector similar to
chargers used on many mobile phones. Please Note: Alternative Wall Chargers
should meet the specifications in the Product Care and Maintenance section.
When operating SKINCLINICAL reverse from a fully charged condition, the
typical treatment time before the green “fully charged” Power On/Battery
Status Indicator color transitions to the yellow “Low Charge” color is
approximately 60 minutes.
SKINCLINICAL reverse is tested as fully compliant with international
standards to ensure that the emitted light will not harm your eyes.
SKINCLINICAL reverse uses the latest state of the art high luminosity narrow
spectral bandwidth LEDs with 4 separate wavelengths or colors of light and
sophisticated micro controller, control and safety features in its design. These
features make it a robust device that will provide many hours of beneficial
treatment time and requires no special care other than a soft dry cloth wipe-
down from time to time. SKINCLINICAL reverse should be used only for the
reduction of fine line facial wrinkles.
SKINCLINICAL reverse is FDA cleared and classified as a medical device for
treatment and reduction of fine line facial wrinkles.
2

product overview
IMPORTANT:
• Please perform the initial Sensitivity Test (see Sensitivity Test section)
before beginning the treatment protocols described in the Treatment
Protocol section to determine if this product is compatible with your skin
type.
• Please read this User & Product Guide in its entirety in advance of the
use of this product.
SKINCLINICAL reverse is an FDA cleared, battery operated, handheld,
Light Emitting Diode (LED) device for the treatment of facial wrinkles.
SKINCLINICAL reverse emits completely safe and gentle combined
doses of Red and Infrared light to stimulate deeper skin tissue. This light
stimulation leads to a reduction of fine line facial wrinkles.
• Turn ON: Hold SKINCLINICAL reverse
in the palm of your hand. Press the on/off
button to power-on.
The Treatment LED above the on/off
button will turn BLUE indicating the unit is
ready to use. The Power LED below the on/
off button will also turn on.
• Turn OFF: Hold SKINCLINICAL reverse
in the palm of your hand. Press the on/off
button to power-off.
Treatment LED
(Blue)
on/off button
Power LED
(Yellow or Green)
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• When SKINCLINICAL reverse is ON, the Power LED should be green.
Green = good battery charge. If the Power LED is YELLOW, this indicates
the battery should be recharged. Please turn the power off, attach the
USB wall mount charger and plug it into the power outlet until “Charge
Status” indicator on the bottom of the product changes from flashing
BLUE color to solid BLUE color. Once solid, the device is ready for use.
• The Power LED may change from GREEN to YELLOW color and you
will hear a beep every 15 seconds advising you that the battery should be
recharged. Once the LED turns YELLOW, there is at least 15 minutes of
good usage time to complete your treatment cycle. After completing that
treatment cycle, power off the device and attach it to the USB wall mount
charger for a full charge before the next treatment.
• To maximize battery life it is best to charge the device only when the
Power LED is yellow.
• It is normal that the plastic case and Stainless Steel ring of the device
become warm to the touch during treatment.
• SKINCLINICAL reverse reduces facial wrinkles with a 3-minute a day
per treatment area schedule. (See Fig. 1 for treatment area examples)
• SKINCLINICAL reverse uses 4 different colors or wavelengths of high
intensity LED light to stimulate collagen activity beneath your wrinkles.
4

Fig. 1 : Examples of treatment areas. The following image and information
will show what to do to accomplish your wrinkle reducing goal.
SKINCLINICAL reverse works best by gliding the unit along small
localized areas of the face, similar in size to the bubbles shown in the
image.
Fig.1
5

sensitivity test
Please Conduct This Test One Time Before Beginning Treatment And
Within A 7-Day Period Of Product Purchase.
Some people may be sensitive to the light outputs of SKINCLINICAL
reverse. Should you fall within the “sensitive” group or experience any
adverse reaction (which is defined as any pain or discomfort in the
treatment area or any skin redness that lasts for longer than 2 hours
after treatment), the device may not be suitable for you. Your sensitivity
to the LED output of the device can be established by the following tests.
LED Light Sensitivity Test:
1) Turn on SKINCLINICAL reverse unit and touch the aperture to your
right forearm leaving it in contact without movement for 4 minutes. (See
Fig. 2)
2) The light output may result in a slight reddening of your skin for a
period of 2 hours after application. This is normal.
3) If any redness or discomfort remains for any period longer than 2
hours, this product is not suitable for you and you may return it with your
original receipt within 7 days from the date of purchase for a full refund.
Fig.2
6

treatment protocol
• Before treatment with the device, it is recommended that you use a high
quality skin cleanser or exfoliating product to remove cosmetic dirt and oily
residues from your face.
•The treatment protocol is simple: select a treatment area and use
SKINCLINICAL reverse for 3 minutes a day on that treatment area. Do this at
least 5 days a week for a period of 8 weeks.
See Fig. 1 for treatment area examples --- For best results, keep the
treatment area for each 3 minute session small and localized, following a 2
inch path along the lines of bubbles shown in Fig 1.
Select a few treatment areas to “concentrate on” and continue the daily
regimen for at least 8 weeks. Facial wrinkles do not appear overnight and
they will not disappear overnight, so it is important to continue the daily
regimen for optimal results.
Note: For each treatment session, please keep the device in contact with the
skin, while gliding it back and forth along the treatment area.
Note: You will hear a beeping sound from SKINCLINICAL reverse as follows:
a) Long beep when SKINCLINICAL reverse is turned on.
b) Three beeps during treatment advising when the 3-minute treatment time
is completed.
c) Two beeps when SKINCLINICAL reverse is turned off.
d) One single beep every 15 seconds advising you that SKINCLINICAL
reverse needs its battery recharged. You should notice a decrease in your
wrinkles over a 3 to 7 week period after the completion of the treatment
sessions.
7

Some people see improvement during the treatment period but predicting
results for all users during the treatment period is not possible.
SKINCLINICAL reverse LED energy stimulates natural biological
processes which lead to reduction of wrinkles. This process is cumulative
and continues after the treatment sessions have stopped so it is
imperative that you follow the treatment daily usage protocol.
precautions
For best results, please clean or wipe down SKINCLINICAL reverse
before treatment with a clean soft dry cloth. You may use a soft cloth
dampened with Isopropyl Alcohol to clean the stainless steel retainer and
polycarbonate lens only.
For protection from risk of damage to SKINCLINICAL reverse, do not leave
any of the components in direct sunlight or in a storage area which may
exceed 50 degrees Celsius / 122 degrees Fahrenheit.
Charge SKINCLINICAL reverse ONLY with the wall charger unit
that is in the product package.
8

product risks
1) Please note that in a typical application you may notice a slight
reddening (erythema) over the treated area which should clear up
within 2 hours. Should this reddening or any perceived discomfort
remain longer than 2 hours after treatment, you may be sensitive to
one or more of the wavelengths of LED light. If you have this sensitivity
response, please cease using SKINCLINICAL reverse and seek advice
from a healthcare professional. (Note skin sensitivity test on page 5 of
the User Guide.)
2) Please note warnings on Pages 16-18 of this manual explaining who
should or should not use the device and other general warnings noted
in this manual.
SKINCLINICAL reverse meets or exceeds International “eye safe”
standards ensuring that the LED power and wavelength outputs will
not harm your eyes.
product care and maintenance
Please keep the lens / stainless steel retainer assembly clean and avoid
scratching the lens as the LED light may be reduced in efficiency which
can lead to a decrease in effectiveness of treatment.
SKINCLINICAL reverse’s plastic housing may be cleaned ONLY with a
clean soft dry NON-ABRASIVE cloth OR an Isopropyl Alcohol wipe. Please
follow these guidelines as cleansers or other more caustic materials may
damage both the housing and the lens surface.
The wall charger unit should not require any cleaning. If you choose to
do so, ALWAYS unplug it and ONLY wipe the outside surfaces with a DRY
cloth.
9

The wall charger unit is designed to operate with an electrical input
between 90-250 Volts, at 50-60 Cycles.
The provided U.L. listed wall charger unit uses a “Micro USB” type
interface plug and is designed to operate with an electrical input between
90 and 250 Volts, at 50 to 60 Cycles. This unit provides a constant current
rating of at least 500Ma (the ratings for any wall charger should be printed
on the housing of any wall charger unit).
NOTE: Any Micro USB Alternate or Substitute wall charger unit MUST
comply with the specifications listed above for reliability and safe
operation of SKINCLINICAL reverse.
For areas outside the United States, please purchase a CE or UL listed
approved mating / conversion plug which conforms to the wall socket
electrical standards for that country.
product disposal
To protect our environment, please return SKINCLINICAL reverse in its
original packaging to SKINCLINICAL for proper unit and Lithium Battery
disposal.
10

labeling
• Labels on the underside of SKINCLINICAL reverse are for indication
and operation.
• The label on the bottom of SKINCLINICAL reverse contains the
following information:
• Model Number, Design / Manufacturer Data and CE marking.
• A date specific laser etched serial number above the USB connector.
• The label on the back side of the wall charger unit contains the
following information:
Model Number
Design/ Manufacturer Data
CE/UL marking
Electrical operational parameters
Bottom View
Treatment LED
(Blue)
on/off button
Power LED
(Yellow or Green)
Charge Status Indicator
Flashing BLUE = Charging
Solid BLUE = Fully charged
Charger connection
11

troubleshooting
SKINCLINICAL records and analyzes all possible faults or issues reported
to us as per FDA guidelines.
The majority of user issues or difficulties should have a simple solution
and are listed in the troubleshooting guidelines below.
However, if the recommended procedure did not fix or address the
problem or the problem reoccurs, please contact SKINCLINICAL by
e-mail (customerservic[email protected]) to address the concerns and
if necessary to arrange service. Please note that any service under the
Warranty MUST be preceded by e-mail contact with our service personnel
who will provide the required RMA (Return Merchandise Authorization)
number for reference. This RMA procedure allows us to improve our
product through ISO Quality improvement programs and if needed to
accurately track and report issues to the FDA as well as provide tracking
date for any warranty repair or replacement of the product.
guidelines for troubleshooting
1) No BLUE Treatment light or GREEN or YELLOW Power LED’s light up
after pressing the on/off button:
Quick Solution: Please plug SKINCLINICAL reverse into the wall
charger and note the BLUE “Charge Status” LED located near the USB
connector on the bottom of the unit. If this LED is flashing blue, please
fully charge the unit until the LED turns solid blue (not flashing).
If the BLUE “Charge Status” LED is solid BLUE, but the Power LED
is not GREEN or remains YELLOW, please contact SKINCLINICAL for
service.
2) No Red LED light is visible from the lens area with SKINCLINICAL
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reverse powered up (ie: Power LED is GREEN and the Treatment LED
is BLUE):
Quick Solution: Please touch the lens and stainless steel retainer to
your skin, and the light will come on.
Note: If the RED LED light from lens area fails to operate with:
A) The BLUE Treatment LED visibly bright.
B) The GREEN Power LED visibly bright.
Please contact SKINCLINICAL for service.
3) Important Note: 4 of the LEDs are Infrared and you will likely not be
able to see any light from them. Some people are able to notice a faint
orange glow from them but if the RED treatment LEDs are visible from
the lens area, then the infrared LEDs will also be on since the same
circuitry powers both RED and infrared LEDs.
4) If the Treatment LEDs or any LEDs for battery status or treatment
appear to flicker, are intermittent or do not turn on at all, please
contact SKINCLINICAL for service.
5) If after any inadvertent impact to your SKINCLINICAL reverse, the
plastic housing part becomes cracked, is dislodged or broken off,
please immediately discontinue usage and contact SKINCLINICAL for
service.
Note: No modification of this product is allowed.
13

warranty
Your SKINCLINICAL reverse is warranted to be free from defect in material
and workmanship for a period of one year from its original purchase date. This
warranty extends only to the original retail purchaser and only when purchased
from an authorized retailer of this product.
If the product should become defective within the warranty period, contact
SKINCLINICAL via one the following methods for repair or replacement:
For Customer Service Team
•Call the business office at: 1(800) 566-1257
•E-mail us at: customerservic[email protected]
•Standard mail correspondence to:
SKINCLINICAL
449 N Canon Drive,
Beverly Hills, CA 90210
SKINCLINICAL reserves the right to replace a defective product with a most
comparable product currently available.
This warranty does not cover products damaged by the following:
Accident, misuse, abuse, alteration, service by unauthorized personnel, use
with unauthorized accessories, connection to incorrect current and voltage,
and any other conditions beyond our control.
SKINCLINICAL SHALL NOT BE RESPONSIBLE FOR ANY INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE
OF THIS PRODUCT. ALL IMPLIED WARRANTIES INCLUDING BUT NOT
LIMITED TO IMPLIED WARRANTIES OF FITNESS FOR PARTICULAR USE AND
MERCHANTABILITY ARE LIMITED IN DURATION TO ONE YEAR FROM THE
DATE OF ORIGINAL PURCHASE.
14

NOTE: This warranty gives you specific legal rights, and you may also
have other rights that vary from state to state. Consult your local
consumer protection agencies to verify if the above limitations and
exclusions apply to you.
declaration of conformity:
SKINCLINICAL®reverse meets the following International Safety
Classifications:
EC 62471 AND EU DIRECTIVE 2006/25/ECIEC classifies SKINCLINICAL®
reverse as RG-0 Exempt : no photobiological hazard.
SKINCLINICAL®reverse emits no potentially hazardous sub-400
nanometer violet radiation and its outputs levels of light energy are far
below and outside of levels considered hazardous to the human optical
path.
SKINCLINICAL®reverse meets applicable EMC/EMI IEC 60601-1 Safety
criteria and is electrically classified as a home use/user safe CISPR
11Group 1 Class B device.
SKINCLINICAL®reverse meets applicable safety requirements under
ANSI/ANSI 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 Part 1 General Requirements for Basic Safety and
Essential Performance.
IEC 60601-1 classifies Medical Devices with electrically conductive parts
that are isolated or floating from earth ground as Applied Parts.
The floating Applied Part on SKINCLINICAL reverse is the Stainless Steel
Ring and the International Type symbol for such classification is below:
Type-BF
15