Nira Skincare laser User manual

Quick Start & Instructions For Use

Part number: 820-005, Rev C

NIRA SKINCARE LASER QUICK START

Treatment Button

NIRA Star Logo

Power Level Indicator

Power Select Button

Laser Aperture

HOW TO TREAT

1Wash & Dry Face

• Remove all makeup thoroughly.

• Cleanse your skin with your preferred skin cleanser.

• Dry your face completely before beginning

treatment.

2Power On Device & Learn Reject Tone

• Turn on device by pressing the power button.

• Identify the reject tone: While holding the device in front of

you as shown with NO direct contact with the skin, press and

release the treatment button. You will hear a low-pitched beep

that indicatesa rejection pulse.

• The rejection tone indicates that the device tip did not have full

contact with the skin. If you hear this tone during treatment you need to

reposition the device tip making sure there is full skin contact.

Battery Indicator

Charging Port

IMPORTANT: Read all instructions before ﬁrst use.

Treatment

• Using the chosen power level hold the device tip

against the skin starting at the outer corner of your

eye.

• Press and release the treatment button while holding

the device tip in place until you hear a series of

two beeps approximately one second apart

indicating that spot has been successfully

• Press and release the power button to adjust

the power level. Set your NIRA Laser to level 1.

(see below)

• Place the device tip on the skin as shown to the

right. Press and release the treatment button

with your thumb; you will hear a series of 2

beeps. The ﬁrst beep indicates the laser has

Find Your Ideal Treatment Level

3 4

Illustration of treatment pattern

FOR BEST RESULTS:

Use the device daily according to the instructions 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.

Place aperture ﬂush with skin

12345

Illustration of power levels from low to high

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 your skin may build up to a point where you

feel discomfort or pain. This is not recommended and should be avoided.

• Reposition the device so it is slightly overlapping the previous treatment

spot (See illustration for overlapping pattern) then press and release the

treatment button again.

• Following the 2-3 row pattern shown in the illustration, repeat this

process for 40 pulses on one eye. Once 40 successful pulses have been

completed, you will hear a set of three 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 power level lights turn off. NIRA will also power down after 2

minutes without use.

• Continue with daily skincare regimen.

begun ﬁring. The second beep indicates the laser ﬁnished ﬁring for that

one spot.

• Repeat this process and continue to increase the power level until you

have reached a power level where you feel warmth without pain.

As we age our bodies naturally stop producing collagen that causes wrinkles and sagging of the skin. The NIRA Skincare

Laser reverses the impact 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 to12 weeks using advanced

dermatologist-tested technology. NIRA holds 11 patents, is FDA cleared and clinically proven to deliver dramatic lasting

results in as little as 2 minutes a day without pain**, redness, skin damage or downtime.

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

** 86% of users found NIRA to be enjoyable to use. A small percentage of users experienced pain, but found that discomfort lessened with proper use.

Watch the NIRA Instructional Video at:

https://www.niraskin.com/how-to-videos/

CONTENTS

HOW TO TREAT ..................................................................................................................................................................................................................................................2

WHO SHOULD USE, WHEN TO USE, WHAT TO EXPECT ...............................................................................................................................................................................6

CHARGING INSTRUCTIONS..............................................................................................................................................................................................................................7

CONNECT YOUR NIRA TO THE iOS APP..........................................................................................................................................................................................................8

TROUBLESHOOTING..........................................................................................................................................................................................................................................9

CLEANING, STORAGE, SERVICE, AND MAINTENANCE..............................................................................................................................................................................10

SAFETY INFORMATION.................................................................................................................................................................................................................................... 11

TRAVEL AND DISPOSAL....................................................................................................................................................................................................................................13

LABELS AND SPECIFICATIONS ........................................................................................................................................................................................................................14

EMC INFORMATION ........................................................................................................................................................................................................................................15

SYMBOLS............................................................................................................................................................................................................................................................19

CONTACT INFORMATION.............................................................................................................................................................................................................................. 20

•All skin tones.

•Anyone over the age of 12 with wrinkles around the eyes.

•Anyone over the age of 12 that wants to decrease the appearance of wrinkles around the eyes.

WHO SHOULD USE NIRA

•When the face is fully clean and dried.

•The NIRA laser can be used in the morning or at night.

•Use the NIRA skincare laser daily. For accelerated results repeat twice daily, but do not treat more than twice within a 1-hour period.

WHEN TO USE NIRA

•Always use NIRA on clean and dry skin.

•During your treatment sessions, use the highest power level where you feel warmth without pain.

•Use a facial moisturizer after each treatment. Daily use of a sunscreen with at least SPF 30 is recommended.

•Daily usage is recommended on an ongoing basis to maintain results.

HOW TO ACHIEVE THE BEST RESULTS

•The ﬁrst treatment session is usually the longest, so it’s best to start when you have more time. After a few treatments, most users are able to complete a full

treatment (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 reaction 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. Apply a moisturizer after treatment to help soothe

dryness.

WHAT TO EXPECT

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

CHARGING INSTRUCTIONS

•First, connect the USB-C cable to the charging port of the device. Next connect the large end of the USB cable to the USB port of your computer, or to the wall

plug adaptor and plug into a wall outlet. Battery indicator lights on the device will start to ﬂash.

•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 between 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. Unplug your NIRA Skincare Laser to begin treatment.

Accessories:

Micro USB 2.0 Type C Cable, 5V 2A Fixed Blade Wall Plug-in Power Supply

Note: Treatment is disabled during charging.

Charger State Battery Indicators Condition

Charger disconnected

Normal operation—Battery over

half charge

Normal operation—Battery less

than half charge

Very low charge. May stop

functioning.

Charger connected

Still charging. Less than half

charge.

Still charging. More than half

charge.

Charge complete.

Disconnect and treat.

Top is OFF

Bottom is Blinking

Top is Blinking

Bottom is ON

Top is ON

Bottom is ON

Top is OFF

Bottom is Blinking

Top is OFF

Bottom is ON

Top is ON

Bottom is ON

DOWNLOAD THE NIRA APP

Our NIRA app is available for iOS only, coming soon to Android.

CONNECTING YOUR NIRA LASER TO THE iOS APP

1. Before connecting, make sure your bluetooth is turned on and

activated on your phone.

2. While the NIRA app is open, turn on your NIRA Laser by

pressing the power button.

3. Simultaneously hold the Power and Treatment buttons for more

than 1 second until the power level lights illuminate from a low

to high, high to low pattern.

4. If requested, enter the number “654321” and click “Pair”, then

wait till you have been directed to the NIRA Customer Portal,

User Registration page.

5. To complete pairing your device, click “New User Registration”

and complete the requested information. Please make sure

to check the small box “I agree with the above Web User

Agreement and Privacy Policy” once you have read the

agreement.

TROUBLESHOOTING: If device does not sync, choose Forget Device within

the phone’s bluetooth menu, and reconnect following the instructions above.

Battery Indicators

Other User Action Reference

Code

Bottom Light

blinking SLOWLY

N/A Charge for > 1 hour. If not ﬁxed, call NIRA Customer

Service. 1

Blinking SLOWLY

B-T-B-T N/A Turn off Laser for > 5 minutes for cooling. If not ﬁxed,

call NIRA Customer Service. 2

Blinking FAST

B-TT-B-TT N/A Reboot device. If not ﬁxed, call NIRA Customer Service. 4

Normal Device makes a single monotone sound

that is different from the normal tones Reboot device. If not ﬁxed, call NIRA Customer Service. 5

Blinking SLOWLY

BB-T-BB-T N/A Reboot device. If not ﬁxed, call NIRA Customer Service. 7

Blinking FAST

BB-TT-BB-TT N/A Reboot device. If not ﬁxed, call NIRA Customer Service. 12

Blinking FAST

B-TTT-B-TTT N/A Reboot device. If not ﬁxed, call NIRA Customer Service. 14

Blinking SLOWLY

at the same time N/A Charge for > 2 hours. If not ﬁxed, call NIRA Customer

Service. 8

Blinking FAST

B-TTT-B-TTT N/A Reboot device. If not ﬁxed, call NIRA Customer Service. 9

Blinking FAST

B-TTTT-B-TTTT N/A Press and release treatment button. If not ﬁxed, call

NIRA Customer Service. 11

N/A Device will not power on Charge for >2 hours. Press Power button for 15 seconds,

then release. If not ﬁxed, call NIRA Customer Service. 13

TROUBLESHOOTING

Refer to this table if you are having

problems operating the device. If you

still have questions, please visit www.

niraskin.com or call NIRA Customer

Service at 781-451-1700.

B—Bottom LED

T—Top LED

SERVICE AND MAINTENANCE

The device does not require assembly or regular maintenance. Never attempt to service it in any manner. If you have any questions

regarding servicing or maintenance, please call Dermal Photonics Corporation. The NIRA Skincare Laser will operate for more than

one year 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 the 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.

ENVIRONMENTAL 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

POTENTIAL SIDE EFFECTS

Side effects that may appear include: skin warmth, redness and stinging. Less frequent side effects that may appear include: dryness, 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.

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 malfunction or serious injury. Do not drop the device on hard surfaces as the device could be damaged. The NIRA Skincare

Laser complies 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 scientiﬁc 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 laser aperture may degrade the performance. Clean the device periodically as instructed. Store the NIRA Skincare Laser in the

supplied box in a secure location away from household animals and children.

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 device 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 skin 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 of

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 - 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 the equipment.

•Do not use on skin that is cut, burned, or infected. Only use on skin that is intact.

•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.

•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 ages 12 and over.

•Always keep the cord away from heated or wet surfaces to prevent damage to the device.

•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.

•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 one person to another and may

cause harmful infection.

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

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 require-

ments 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 at the collection point or the

Dermal Photonics service center will ensure the battery is removed and disposed of in an environmentally safe way.

LABELING AND SPECIFICATIONS

The NIRA Skincare Laser is a Class 1C laser operating at the speciﬁcations listed in the table below. The laser aperture integrates 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 2ADZENIRC

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 FCC Rules. These limits are designed to provide

reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate 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 that interference will not occur in a particular installation. 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.

EMC INFORMATION

The NIRA Skincare Laser needs special precautions regarding EMC and needs to be installed according to EMC information. The device 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.

RF emissions CISPR 11 Group 1 The NIRA Skincare Laser 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.

RF emissions CISPR 11 Class B

The NIRA Skincare Laser 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

Voltage ﬂuctuations/ ﬂicker emissions IEC

61000-3-3 Complies

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)

IEC 61000-4-2

+8 kV contact

+15 kV air Complies

Electrical fast transient/ burst

IEC 61000-4-4

+2 kV for power supply lines

+1 kV for input/output lines. Complies Mains power quality should be that of a typical home, commercial or

hospital environment.

Surge

IEC 61000-4-5

+1 kV differential mode

+2 kV common mode Complies Mains power quality should be that of a typical home commercial or

hospital environment.

Voltage dips, short interrupts 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

Complies

Power frequency (50/60 Hz)

magnetic ﬁeld

IEC 61000-4-8

3 A/m Complies

Power frequency magnetic ﬁelds should be at levels

characteristic of a typical location in a typical home, commercial or

hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Electromagnetic Immunity Declaration

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

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

Conducted RF

IEC 61000-4-6



Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz



10 V/m

80 MHz to 2.5 GHz

3 V



10 V/m

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 equation

applicable to the frequency of the transmitter. Recommended separation distance

d = 1.17 150 kHz to 80 MHz

d = 1.17 80 MHz to 800 MHz

d = 2.33 800 MHz to 2.5 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 meters (m).Field strengths from ﬁxed RF

transmitters, as determined by an electromagnetic site survey,

should be less than the compliance level in

each frequency range.



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.

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 observed to verify normal operation. If abnormal performance is observed, additional

measures may be necessary, such as reorienting or relocating the NIRA Skincare Laser.

Over the frequency range 150 kHz to 80 MHz, ﬁeld strengths should be less than 3 V/m.

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 controlled. The customer or the user of the NIRA Skincare

Laser can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the NIRA

Skincare Laser as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)

Separation distance according to frequency of the transmitter (m)

150 kHz to 80 MHz

d = 1.17

80 MHz to 800 MHz

d = 1.17

800 MHz to 2.5 GHz

d = 2.33

0.01 0 .12 0 .12 0.23

0 .1 0.37 0.37 0.74

11.17 1.17 2.33

10 3.70 3.70 7. 37

100 11 . 7 0 11 . 7 0 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 fre-

quency 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.