User Manual 820-005_XC NIRA WRINKLES IFU 7.4 x 3.9.pdf

FCC ID: 2ADZENIRD

Users Manual

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                              Quick Start & Instructions For Use

Part number: 820-005, Rev C


                                                          QUICK START
                NIRA SKINCARE LASER                                                                  HOW TO TREAT
                                                                        1      Wash & Dry Face

Laser Aperture —                                                            Remove all makeup thoroughly.
Delivers Laser Light
During Treatments                                                           Cleanse your skin with your preferred skin cleanser.
                                Treatment Button —
                                Push to fire laser for treatment
                                                                            Dry your face completely before beginning treatment.



                                                                        2      Power On Device

                                                                            Turn on device by pressing the power button for roughly 1 second.
NIRA Star Logo —
Indicates Laser Device is on                                                Identify the reject tone: While holding the device in front of you and
                                 Power Level Setting —
                                 Displays the treatment power level         making sure the device tip has NO direct contact with the skin, press
                                                                            and release the treatment button. You will hear a set of quick
                                 Battery Indicator —
                                 Bottom level light blinks when the         low-pitched beeps that indicate a rejection pulse.
Power On & Power                 battery needs to be recharged
                                                                            The rejection tone indicates that the device tip did not have full contact with the skin. If
Select Button —
Turns NIRA laser on/off,         Charging Port —                            you hear this tone during treatment you need to reposition the device tip making sure
adjusts the power levels of      Connection port to charge the device
the laser                                                                   there is full skin contact.
                                                                                                                                                                       2


3     Test Treatment Level                                                              4     Treatment

    Press and release the power button to adjust the                                        Using the chosen power level hold the device tip against the skin starting at the outer
    power level. Set your NIRA Laser to level 1.                                            corner of your eye.
    Place the device tip on the skin as shown to the                                        Press and release the treatment button while holding the
    right. Press and release the treatment button with                                      device tip in place until you hear a series of two beeps
    your thumb; you will hear a series of 2 beeps. The                                      approximately one second apart indicating that spot has
    first beep indicates the laser has begun firing and the                                 been successfully treated.                                      Illustration of treatment pattern

    second beep indicates the laser finished firing for                                     Reposition the device so it is slightly overlapping the previous treatment spot (See
    that one spot.                                                                          illustration for overlapping pattern) then press and release the treatment button again.
    Repeat this process and continue to increase the                                        Repeat this process for 40 pulses on one eye following the 2-3 row pattern shown in
    power level until you have reached a power level                                        the illustration. Once 40 successful pulses are completed, you will hear a set of three
    where you feel warmth without pain.                                                     fast-paced jingle-like tones that indicate the treatment for that eye is complete.
                                                                                            Repeat this process for the opposite eye.
                                                                                            Power down the device by holding down the power button until the NIRA logo and
    CAUTION: Be sure to move the NIRA to a new spot for each treatment. If you              power level lights turn off.
    treat the same spot twice in a row, the heat in your skin may build up to a point       Continue with daily skincare regimen.
    where you feel discomfort or pain. This is not recommended and should be                For Best Results, repeat this process daily for 90 days or more. To enhance your results
    avoided.                                                                                you may treat twice daily.                                                                     3


WELCOME TO NIRA—INSTRUCTION FOR USE
Your journey to beautiful, better–looking skin.

NIRA’s revolutionary new technology holds 6 patents, is FDA cleared, and clinically proven to deliver dramatic lasting results in as little as 2
minutes a day, at home, without pain, redness, skin damage or downtime.

As we age our bodies naturally stop producing collagen that causes wrinkles and sagging of the skin. The NIRA Skincare Laser reverses the im-
pact of aging by warming the deeper layers of your skin, activating the skin to produce collagen like it did decades ago to give you the healthy,
beautiful and youthful looking skin that you deserve.

The NIRA Skincare Laser provides lasting results* to reverse the signs of aging in as little as 8 to 12 weeks using advanced dermatologist-tested
technology.

Before using your device for the first time, it is important to read the instructions and safety information in this booklet to ensure proper use
and to achieve your best results. We recommend saving these instructions for future reference.

*based on clinical results with 3-months post-treatment observations



                                                  Watch the NIRA Instructional Video at:
                                           https://www.niraskin.com/how-to-videos/
                                                                                                                                                    4


CONTENTS

INSTRUCTION FOR USE .............................................................................................................................................................................................................................. 4
SYMBOLS .................................................................................................................................................................................................................................................... 6
USER EXPERIENCE AND SAFETY INFORMATION ........................................................................................................................................................................................ 7
POTENTIAL SIDE EFFECTS ........................................................................................................................................................................................................................... 9
WHO SHOULD USE, WHEN TO USE, ACHIEVING BEST RESULTS, WHAT TO EXPECT ............................................................................................................................... 10
PRE-TREATMENT INSTRUCTIONS ............................................................................................................................................................................................................. 11
TREATMENT GUIDELINES ......................................................................................................................................................................................................................... 12
CHARGING INSTRUCTIONS ...................................................................................................................................................................................................................... 14
CLINICAL STUDY RESULTS ........................................................................................................................................................................................................................ 15
CLEANING, STORAGE, SERVICE, AND MAINTENANCE ............................................................................................................................................................................. 16
LABELS AND SPECIFICATIONS .................................................................................................................................................................................................................. 17
TRAVEL AND DISPOSAL ............................................................................................................................................................................................................................ 18
TROUBLESHOOTING ................................................................................................................................................................................................................................. 19
EMC INFORMATION ................................................................................................................................................................................................................................. 20
CONTACT INFORMATION ......................................................................................................................................................................................................................... 24




                                                                                                                                                                                                                                                           5


SYMBOLS
The following symbols are used within this manual or on the NIRA Skincare Laser and its packaging:




                     Consult Instruction For Use                               Serial Number                                  Non-ionizing Radiation

                     Protection against finger-sized ob-
       IP22                                                                    Date of Manufacture                            Use only with NIRA Supply Unit
                     jects. Protected against dripping
                     water. The device is not submersible.
                                                                               Fragile, Handle with Care                      Read Operator’s Manual
                     Type BF Applied Part


                                                                               Keep Dry                                       Laser Radiation Warning
                     Temperature Range

                                                                               Caution – see Safety Information in this       WARNING: Do not use this
                                                                               document                                       appliance near bathtubs, showers, basins
                     Relative Humidity Range
                                                                                                                              or other vessels containing water.
                                                                               Standby & Ready
                     Pressure Range

                                                                               Class II Double Insulation Electrical Appli-
                                                                               ance
                                                                                                                                                                    6


USER EXPERINCE
In a clinical study users of the NIRA Skincare Laser completed anonymous surveys about their experiences and found:
       99% of users felt the NIRA Skincare Laser was easy to use.
       87% of users enjoyed using the NIRA Skincare Laser.
For best results, use the device daily according to the instructions for 90 days or more. Lasting results should become appar ent after 4 weeks and become more noticeable after
8 - 12 weeks of use. Excellent results require patience and persistence along with daily treatments to allow your skin’s natural mechanisms to repair and improve your skin from within.


SAFETY INFORMATION
Read all important safety information on pages 7 and 8 prior to using the NIRA Skincare Laser.

WHEN TO USE (INDICATIONS)
      The NIRA Skincare Laser is an over-the-counter device intended to treat periorbital wrinkles (wrinkles around the eyes).

WHEN NOT TO USE (CONTRAINDICATIONS)
      Do not use on skin that is cut, burned, or infected. Only use on skin that is intact.
      Do not use if under 12 years of age or with reduced physical, sensory or mental capabilities.
      Do not use if you are pregnant, nursing or undergoing fertility treatments.
      Do not use if you have a history of skin cancer, or any other type of cancer, or pre-malignant moles.
      Do not use if you have any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosace a.


REGULATORY COMPLIANCE
NIRA Skincare Laser is FDA Cleared for home use for periorbital wrinkles (wrinkles around the eye) and is CE marked for the s ame.




                                                                                                                                                                                       7


         SAFETY INFORMATION - WARNINGS
      To prevent serious injury, you must follow these Instructions for Use when using the NIRA Skincare Laser.
      Changes or modifications not expressly approved by Dermal Photonics Corporation could void the user’s authority to operate th e equipment.
      If you experience skin color darkening, discontinue use and check with your doctor.
      Do not treat if you have tanned skin. Tanned skin is at an increased risk of adverse effects with light -based devices.
      Avoid sun tanning bed exposures and apply SPF 30 or greater when outside within 6 weeks of treatment.
      The NIRA Skincare Laser is not intended for use by individuals (including children) with reduced physical, sensory, or mental capabilities.
      Children should be supervised to ensure they do not play with the appliance.
      For use only with adolescents 12 and over.
      Do not point or place the treatment tip over your eye or eyelid; serious or permanent eye damage may result.
      Do not place or drop your device or charger near or into water or liquid.
      Do not use the device while bathing. Doing so could result in serious injury.
      Always keep the cord away from heated or wet surfaces to prevent damage to the device.
      Ensure the skin and treatment tip are dry before treatment. The device may not operate properly if the treatment tip is wet. Such failure to operate properly
       may cause serious side effects or device malfunction.
      Do not treat the same spot more than once within a 1 minute period and do not treat more than twice within a 1 -hour period. Multiple immediate treatments
       may result in discomfort or increased side effects.
      Do not share the NIRA Skincare Laser with other people. Sharing the device could transfer bacteria or other pathogens from on e person to another and may
       cause harmful infection.

Use only with the power supply unit and USB-C cable provided.




                                                                                                                                                                       8


SAFETY INFORMATION - WARNINGS
Do not use the NIRA Skincare Laser if the device or the charger is visibly damaged. Never attempt to open or repair the devic e or charger; doing so could result in a serious eye
or skin injury, or possibly fatal electrical shock. Stop using the device and consult your doctor if you feel pain or your sk in gets uncomfortably hot during treatment. Continued
use of the device could result in serious skin injury. Stop using the device if you see unwanted hair growth. Application o f lasers and IPL for hair reduction to the lower face,
particularly near the side burns, has been associated with a risk of paradoxical hair growth. This risk is proposed to arise from low level heating of the hair follicles.



SAFETY INFORMATION - PRECAUTIONS
If you have a skin condition or are undergoing professional cosmetic treatments such as injectable toxins (such as Botox) or fillers, please check with your doctor or clinician
prior using the NIRA Skincare Laser. Only use the charger and USB-C cord supplied to recharge the device. Using a different charger or USB-C cord could cause device malfunc-
tion or serious injury. Do not drop the device on hard surfaces as the device could be damaged. The NIRA Skincare Laser compl ies with standards regarding electromagnetic
fields (EMF). If handled properly and according to the instructions in this booklet, the device is safe to handle based on s cientific evidence available today. Store the NIRA
Skincare Laser in the supplied box to prevent lint or dust collection inside the laser aperture. Lint or dust inside the las er aperture may degrade the performance. Clean the
device periodically as instructed on page 16. Store the NIRA Skincare Laser in the supplied box in a secure location away from household animals and children.



POTENTIAL SIDE EFFECTS
Side effects that may appear include: skin warmth, redness and stinging. Less frequent side effects that may appear include: dryne ss, roughness, tanned
appearance to the skin, swelling, flaking, itching, crusting, bruising, pimple -like rash, irritated skin, blistering, scarring, infection, and skin color
changes where your skin may become darker or lighter in color.




                                                                                                                                                                                  9


WHO SHOULD USE NIRA
   All skin tones.
   Anyone with wrinkles around the eyes.
   Anyone that wants to decrease the appearance of wrinkles around the eyes.
WHEN TO USE NIRA
   When the face is fully clean and dried.
   The NIRA laser can be used in the morning or at night when you are not in a hurry or tired.
   Use the NIRA skincare laser daily. For accelerated results repeat twice daily, but do not treat more than twice within a 1 -hour period.
ACHIEVING BEST RESULTS
     Wash and completely dry treatment areas before using the NIRA Skincare Laser.
     Treat each under eye area once each day.
     During your treatment sessions, use the highest power level where you feel warmth without pain.
     Use a facial moisturizer after each treatment.
     For the best results, daily usage is recommended for 4 months.
WHAT TO EXPECT
   Users typically experience improvements within the first few weeks but notice the most dramatic results after 2 – 3 months of daily use.
   The first treatment session is usually the longest, so it's best to start when you have more time. Within a few uses, most us ers complete a full treatment around the eyes (40
      pulses per eye) in 2 - 3 minutes.
   Immediately after treatment, you may feel a warming sensation similar to how a mild sunburn might feel. This is a normal reac tion that will lessen within an hour following
      treatment. If you find it uncomfortable, reduce the power levels in subsequent treatments.
   During the first month, you may experience some temporary redness, which is rare. If you treat yourself at night, the redness will diminish while you sleep.
   Some users may notice that their skin becomes rough and/or dry during the first month of use. Try applying a moisture cream a fter treatment to help soothe any dryness.
      Continue to use moisturizing skincare products during the day. Daily use of a sunscreen with at least SPF 30 is recommended.
                                                                                                                                                                                      10


PRE-TREATMENT INSTRUCTIONS
Step One
     Remove all makeup thoroughly
     Cleanse your skin with your preferred skin cleanser.
     Dry your face completely before you begin treatment.
Step Two
     Unplug battery charger prior to use. The NIRA Skincare Laser will not operate while the device is connected to the USB C.
Step Three
     Turn on device by pressing the power button for approximately 1 second; you will hear a set of beeps and the NIRA Star logo a nd power level lights will turn on.
Step Four
     Identify the reject tone: While holding the device in front of you and making sure the device tip has NO direct contact with the skin,
        press and release the treatment button. You will hear a set of quick low-pitched beeps that indicate a rejection pulse.
     The rejection tone indicates that the device tip did not have full contact with the skin. If you hear this tone during treatm ent you need
        to reposition the device tip making sure there is full skin contact.

Step Five
     Set the treatment power level to 1 by pressing and releasing the power button quickly until only one light displays in the po wer level setting area. (Illustration
        of power levels low to high is shown to the right)
     Test this power level by placing the device tip on the skin under the outer corner of your eye. While holding the device tip in place, press and release the
        treatment button until you hear two high pitched beeps approximately 1 second part from another.
        Note: If you hear the rejection tone when pressing the treatment button this may be because the device tip lost contact with the sk in.
        Reposition the device tip making sure there is full skin contact and try again.
     For best results use the highest power level setting where you feel warmth without pain. You can adjust the power level setti ng by pressing and releasing the
        power button.
                                                                                                                                                                            11


TREATMENT GUIDELINES
While looking in a mirror and keeping both eyes open, treat each wrinkle with a series of individual pulses.

Step One
     Using the chosen power level, hold the device tip against the skin under the outer corner of your eye.

Step Two
     Press and release the treatment button with your thumb while holding the device tip in place until you hear a series of 2 bee ps approxi-
      mately 1 second apart. The first beep indicates the laser has begun firing and the second beep indicates the laser finished fi ring for that
      one spot.
      Note: Be sure you are hearing the treatment tone and not the rejection tone. Follow step 4 in the “Pre -Use Instructions” section to make
      sure you can correctly identify the reject tone.
     Reposition the device so it is slightly overlapping the previous treatment spot (See illustration for overlapping pattern) th en press and
      release the treatment button again. Repeat this process for 40 pulses on one eye following the 2 -3 row pattern shown in the illustra-
      tion. Once completed, you will hear a set of three fast-paced jingle-like tones that indicate the treatment for that eye is complete.




For best results, use the device daily according to the instructions for 90 days or more. Lasting results should become appar ent after 4 weeks
and become more noticeable after 8 and 12 weeks of use. Excellent results require patience and persistence along with daily
treatments to allow your skin’s natural mechanisms to repair and improve your skin from within.                                                      Illustration of treatment pattern


CAUTION: Be sure to move the NIRA to a new spot for each treatment. If you treat the same spot twice in a row, the heat in yo ur skin may build
up to a point where you feel discomfort or pain. This is not recommended and should be avoided.
                                                                                                                                                                                         12


TREATMENT GUIDELINES
Step Three
     Repeat this process on the opposite side for 40 pulses or until you hear the jingle -like tone again.
     Repeat twice daily to accelerate results. Do not treat more than twice within a 1 -hour period.

Step Four
     When finished, check your device battery level to determine if recharging is necessary.
     Press and hold the power button for approximately 2 seconds to power down the device. You will hear a power down set of beeps and
        the lights will turn off. The device will automatically power down after 2 minutes with no activity.
     It is recommended to clean the exterior of the Laser after each use with a damp cloth.

Step Five
     Continue with your daily skincare routine. The use of a moisturizer and sunscreen with SPF of 30 or greater on the treatment area is
        recommended.

For Best Results
Repeat this process daily for 90 days or more. You may use twice daily for possible enhanced results; we recommend waiting 1 minute before
retreating each area. Do not treat more than twice within a 1-hour period.




                                                                                                                                             13


CHARGING INSTRUCTIONS
    First, connect the USB C cable to the charging port of the device.
    If using your computer to charge, connect the large end of the USB cable to the USB port of your computer.
    Alternately, connect the large end of the USB cord to the wall plug adaptor and plug into a wall outlet.
    When your NIRA Skincare Laser is connected to a power source, the battery indicator lights will flash until the battery is fu lly charged. Once the battery is fully charged, the
     battery indicator lights will stop flashing. It should take no longer than 3 hours to fully charge the device.
    A fully charged device will last approximately 4 hours of continuous use. This equates to several weeks of daily usage betwee n charges. This time will vary with settings and will
     lessen as the battery ages.
    Your NIRA Skincare Laser will not work when it is plugged into the battery charger.           Charger State           Battery Indicators           Condition
     Unplug your NIRA Skincare Laser before treatment.
                                                                                                                                  Top is ON             Normal operation—Battery
                                                                                                                                  Bottom is ON          over half charge

                                                                                                                                 Top is OFF           Normal operation—Battery
                                                                                                Charger disconnected             Bottom is ON         less than half charge

                                                                                                                                Top is OFF            Very low charge. May stop
                                                                                                                                Bottom is Blinking    functioning.

                                                                                                                                 Top is OFF           Still charging. Less than half
                                                                                                                                 Bottom is Blinking   charge.

                                                                                                                                Top is Blinking       Still charging. More than
                                                                                                Charger connected                                     half charge.
                                                                                                                                Bottom is ON
                          Note: Treatment is disabled during charging.
                                                                                                                                Top is ON             Charge complete.
                                                                                                                                Bottom is ON          Disconnect and treat.
    Accessories: Micro USB 2.0 Type C Cable, 5V 2A Fixed Blade Wall Plug-in Power Supply

                                                                                                                                                                                       14


CLINICAL RESULTS
In a clinical study using the NIRA Skincare Laser, 3 medical professionals reviewed data in a blinded fashion and rated wrinkle treatment results on a 9-point scale and found on average:
         61% of users saw 1 full wrinkle scale unit improvement within 3 months
         12% of users saw 2 full wrinkle scale unit improvements within 3 months
         59% of users saw 1 full wrinkle scale unit improvement within 4 months
         17% of users saw 2 full wrinkle scale unit improvements within 4 months
         57% of users saw 1 full wrinkle scale unit improvement within 5 months
         20% of users saw 2 full wrinkle scale unit improvements within 5 months
         63% of users saw 1 full wrinkle scale unit improvement within 6 months
         22% of users saw 2 full wrinkle scale unit improvements within 6 months
         69% of users saw 1 full wrinkle scale unit improvement within 7 months
         36% of users saw 2 full wrinkle scale unit improvements within 7 months
         10% of users saw 3 full wrinkle scale unit improvements within 7 months
         81% of users maintained wrinkle improvement for at least 2 months after users stopped using NIRA
         68% of users maintained wrinkle improvement for at least 3 months after users stopped using NIRA

Side effects that may appear include: skin warmth and stinging. Less frequent side effects that may appear include: dryness, and temporary skin color changes where your skin may
become darker or lighter in color. Clinical study users were trained on the use of the device.




                                                                                                                                                                                      15


SERVICE AND MAINTENANCE
The device does not require assembly or regular maintenance. Never attempt to service it in any manner. If you have any questi ons regarding
servicing or maintenance, please call Dermal Photonics Corporation. The NIRA Skincare Laser will operate for more than one ye ar of recommended use.


CLEANING AND DISINFECTION
The interior of the tip should be cleaned once a week with a cotton swab. Gently place the cotton swab into the opening on th e Laser Aperture to
clean the glass lens and remove any debris. If debris has fallen into the laser output window and it will not come out using the cotton swab, gently
shake the device to let the debris fall out. Disinfect all surfaces with 70% alcohol solution between each use.


ENVIRONMENT CONDITIONS
The NIRA Skincare Laser should be used in a comfortable environment.
     Temperature: 15°C to 35°C (59°F to 95°F)
     Relative Humidity: 30-75%
     Atmospheric Pressure: 70-106 kPa


REQUIRED SHIPPING AND STORAGE CONDITIONS
The NIRA Skincare Laser should be stored in a dry place at normal room temperature.
     Shipping Temperature: –40°C to 50°C (-40°F to 122°F)
     Storage Temperature: –20°C to 35°C (-4°F to 95°F)
     Relative Humidity: 10-100%
     Atmospheric Pressure: 50-106 kPa



                                                                                                                                                       16


LABELING AND SPECIFICATIONS
The NIRA Skincare Laser is a Class 1C laser operating at the specifications listed in the table below. The laser aperture int egrates a touch sensor requiring skin contact in order to treat.


                                                                                Specifications

                                                   Wavelength                                1450nm (+/- 20nm)
                                                   Pulse Duration                            0.8 s
                                                   Maximum Power Output                      2.0 W



  FCC ID 2ADZENIRD
  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 operations.
  This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the F CC Rules. These limits are designed to provide
  reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radi ate radio frequency energy and, if not installed and used
  in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee t hat interference will not occur in a particular installa-
  tion. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is
  encouraged to try to correct the interference by one of the following measures:
         Reorient or relocate the receiving antenna.
         Increase the separation between the equipment and receiver.
         Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
         Consult the dealer of an experienced radio/TV technician for help.

                                                                                                                                                                                                 17


TRAVEL
If traveling with NIRA Skincare Laser, be sure to pack the device in its original packaging to prevent damage. Always check the country’s voltage requirements when traveling
outside the United States. The device can operate between 100 – 240 VAC and 50 – 60 Hz. You may need a wall plug adapter or different wall plug blades to charge the NIRA
Skincare Laser when traveling abroad.



DISPOSAL
As appropriate disposal of the device at the end of its life is an integral part of our sustainability policy, we ask you to observe the following:
      Do not throw away the device with the normal household waste at the end of its life, but hand it in at an official collection point for recycling.
      This device contains a built-in lithium-ion rechargeable battery that cannot be removed. This rechargeable battery contains substances that may pollute the
        environment.
      To ensure proper disposal, take the device to an official collection point or return to Dermal Photonics Corporation. Staff a t the collection point or the
        Dermal Photonics service center will ensure the battery is removed and disposed of in an environmentally safe way.




                                                                                                                                                                                18


TROUBLESHOOTING                                                   Front Light Indicates              Battery Indicators                      User Action                          Reference Code
Refer to this table if you are having problems
operating the device. If you still have questions,   Power lights on but Usage            light       Normal              Replenish Usage                                               2
                                                     lowest level blinking
please visit www.niraskin.com or call NIRA
Customer Service at 781-451-1700.                    Power lights on but All Usage           light    Blinking SLOWLY
                                                                                                      B-T-B-T             Replenish Usage                                               3
                                                     lowest level blinking                            Blinking FAST
                                                                                                      B-TT-B-TT
                                                                                                                          Call NIRA Customer Service                                    5

                                                                                                      Blinking SLOWLY     Turn off NIRA and Turn back on. If not resolved, call
                                                                                                      BB-T-BB-T                                                                         7
                                                                                                                          Customer Service
                                                                                                      Blinking SLOWLY
                                                                                                      at the same time    Charge NIRA by plugging into electrical outlet                8

                                                                                                      Blinking FAST
                                                     All Front lights off - can't treat               B-TTT-B-TTT         Call NIRA Customer Service                                    9


                                                                                                                          Call NIRA Customer Service                                    10

                                                                                                       Blinking FAST
                                                                                                                          Release Treatment button. Call NIRA Customer
                                                                                                       B-TTTT-B-TTTT                                                                    11
                                                                                                                          Service

                                                                                                      Blinking FAST       Call NIRA Customer Service                                    12
                                                                                                      BB-TT-BB-TT

                                                                                                       Blinking FAST
                                  B—Bottom LED                                                         B-TTTTT-B-TTTTT    Release Power button. Call NIRA Customer Service              13
                                  T—Top LED
                                                                                                                                                                                             19


EMC INFORMATION
The NIRA Skincare Laser needs special precautions regarding EMC and needs to be installed according to EMC information. The d evice contains hardware capable of Bluetooth Low
Energy (BLE) communication. This hardware can receive and transmit RF energy in 2400 —2483.5 MHz frequency range with DSSS modulation. It is compliant with CFR Title 47, FCC part
15.249 and ETSI EN 300-400 standards, and equivalent isotropically radiated power is less than 10 dBm (10mW).

    Caution: Mobile RF communications equipment can affect the NIRA Skincare Laser device.
    Warnings: The use of accessories and cables other than those specified in this document may result in increased emissions or decreased immunity of the NIRA Skincare Laser.
    Warnings: The NIRA Skincare Laser should not be used adjacent to or stacked with other equipment treatments.



                                                                      Electromagnetic Emissions Declaration

   The NIRA Skincare Laser is intended for use in the electromagnetic environment specified below. The customer or the user of the NIRA Skincare Laser should assure that it is
   used in such an environment.
                                                                         The NIRA Skincare Laser uses RF energy only for its internal function. Therefore, its RF emissions are very
   RF emissions CISPR 11                           Group 1
                                                                         low and are not likely to cause any interference in nearby electronic equipment.
   RF emissions CISPR 11                          Class B
                                                                          The NIRA Skincare Laser is suitable for use in all establishments, including domestic establishments and
   Harmonic emissions IEC 61000-3-2               Complies                those directly connected to the public low-voltage power supply network that supplies buildings used for
                                                                          domestic purposes.
   Voltage fluctuations/ flicker emissions IEC
                                                  Complies
   61000-3-3




                                                                                                                                                                                       20


                                                                      Electromagnetic Immunity Declaration

The NIRA Skincare Laser is intended for use in the electromagnetic environment specified below. The customer or the user of the NIRA Skincare Laser should assure that it is used in
such an environment.
Immunity test                            IEC 60601test level                               Compliance level           Electromagnetic environment – guidance


Electrostatic discharge (ESD)            +8 kV contact
                                                                                           Complies
IEC 61000-4-2                            +15 kV air


Electrical fast transient/ burst         +2 kV for power supply lines                                                 Mains power quality should be that of a typical home, commercial
                                                                                           Complies
IEC 61000-4-4                            +1 kV for input/output lines.                                                or hospital environment.
Surge                                    +1 kV differential mode                                                      Mains power quality should be that of a typical home commercial
                                                                                           Complies
IEC 61000-4-5                            +2 kV common mode                                                            or hospital environment.
Voltage dips, short interrupts and       <5 % UT (>95 % dip in UT)
voltage variations on power supply       For 0,5 cycle 40 % UT
input lines                              (60 % dip in UT) for 5 cycles                     Complies
                                          70 % UT (30 % dip in UT) for 25 cycles
IEC 61000-4-11                           <5 % UT (>95 % dip in UT) for 5 sec

Power frequency (50/60 Hz)                                                                                            Power frequency magnetic fields should be at levels
magnetic field                           3 A/m                                             Complies                   characteristic of a typical location in a typical home, commercial or
IEC 61000-4-8                                                                                                         hospital environment.
                                                         NOTE UT is the a.c. mains voltage prior to application of the test level.
                                                                                                                                                                                        21


                                                                                 Electromagnetic Immunity Declaration
The NIRA Skincare Laser is intended for use in the electromagnetic environment specified below. The customer or the user sho uld assure that it is used in such an environment.

Immunity test                      IEC 60601 test level           Compliance level           Electromagnetic environment – guidance

                                                                                             Portable and mobile RF communications equipment should be used no closer to any part of the NIRA
                                                                                             Skincare Laser including cables, than the recommended separation distance calculated from the equa-
                                                                                             tion applicable to the frequency of the transmitter. Recommended separation distance
                                                                                             d = 1.17

Conducted RF                       3 Vrms                                                    d = 1.17        80 MHz to 800 MHz
                                                                  3V
IEC 61000-4-6                      150 kHz to 80 MHz
                                                                                             d = 2.33        800 MHz to 2,5 GHz

Radiated RF                        10 V/m                                                    where P is the maximum output power rating of the transmitter in watts (W) according to the trans-
                                                                  10 V/m                     mitter manufacturer and d is the recommended separation distance in meters (m). Field strengths
IEC 61000-4-3                      80 MHz to 2,5 GHz
                                                                                             from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the
                                                                                             compliance level in each frequency range. b
                                                                                             Interference may occur in the vicinity of equipment marked with the following symbol:



NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
    Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
         theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in
         which the NIRA Skincare Laser is used exceeds the applicable RF compliance level above, the NIRA Skincare Laser should be obs erved to verify normal operation. If abnormal performance is observed,
         additional measures may be necessary, such as reorienting or relocating the NIRA Skincare Laser.
b
    Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
                                                                                                                                                                                                                  22


              Recommended separation distances between portable and mobile RF communications equipment and the NIRA Skincare Laser
The NIRA Skincare Laser is intended for use in an electromagnetic environment in which radiated RF disturbances are controlle d. The customer or the user of the NIRA Skin-
care Laser can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF com munications equipment (transmitters)
and the NIRA Skincare Laser as recommended below, according to the maximum output power of the communications equipment.
                                                                                  Separation distance according to frequency of the transmitter
                                                                                                               M
  Rated maximum output power of transmitter                 150 kHz to 80 MHz                       150 kHz to 80 MHz                             150 kHz to 80 MHz
                    W
                                                                  d = 1,17                                d = 1,17                                     d = 2,33


                      0,01                                         0,12                                    0,12                                         0,23
                       0,1                                         0,37                                    0,37                                         0,74
                        1                                          1,17                                    1,17                                         2,33
                       10                                          3,70                                    3,70                                         7,37
                       100                                         11,70                                   11,70                                        23,30
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.


                                                                                                                                                                              23


     Dermal Photonics
100 Corporate Pl, Suite 303
   Peabody, MA 01960
      Customer Care
       781-451-1700
    info@niraskin.com
    www.niraskin.com



Document Created: 2019-05-18 13:28:13
Document Modified: 2019-05-18 13:28:13

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