Nira Pro User manual

Quick Start & Instructions For Use

NIRA Pro

QUICK START

HOW TO USE

1Wash & Dry Face

• Remove all makeup thoroughly.

• Cleanse your skin with your preferred skin cleanser.

• Dry your face completely before using this device.

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, brieﬂy contact the device with your skin and

immediately lift the device away from your skin. You will

hear a low-pitched beep that indicates a rejection pulse.

• The rejection tone indicates that the device tip did not

have full contact with the skin. If you hear this tone, lift the

device tip and place on the skin making sure there is full

skin contact for the full cycle.

IMPORTANT: Read all instructions before ﬁrst use. CAUTION: Do not apply the device in the same spot twice in a row as the heat may build up

and you may feel discomfort.

Power Level Indicator

Power Select

Button

Laser

Aperture

Battery Indicator

Charging Port

Application

• Press and release the power button to adjust the power level. Set your

NIRA Pro to level 1. (see below)

• Place the device tip on the skin. The device will automatically ﬁre the

laser once. You will hear a series of 2 beeps. The ﬁrst beep indicates

the laser has begun ﬁring. The second beep indicates the laser

ﬁnished ﬁring for that one spot.

• Move the laser, repeat this process and continue to increase the

power level until you have reached a power level where you feel

warmth without pain.

Find Your Ideal Power Level

3 4

CAUTION: Be sure to move the laser to a new spot for each pulse. If you apply to 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.

Illustration of power levels from low to high

• Using the chosen power level, hold the device tip

against the skin beginning at the desired target area.

• Hold the device tip in place until you hear a series

of two beeps approximately one second apart

indicating that the pulse has been completed.

• Lift and move the laser so it is slightly overlapping

with the previous spot (See illustration for

overlapping application pattern).

• Follow the pattern shown in the illustration, repeat this process for 10

pulses on the desired target area. Once 10 successful pulses have been

completed, you will hear a set of three fast-paced jingle-like tones that

indicate the application for that area is complete.

• Repeat this process for all desired target areas.

• Power down the device by holding down the power button until the

power lights turn off. NIRA will automatically power down after 2

minutes without use.

• Continue with daily skincare regimen.

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 reapplying to

each area. Do not apply more than twice within a 1-hour period.

Application pattern

APPLICATION GUIDELINES

Illustration of Application Pattern Illustration of Application Area

As we age, our bodies naturally stop producing collagen,

causing the skin to wrinkle and sag. NIRA Pro reverses

the impact of aging by warming the deeper layers of your

skin, triggering you skin to renew for healthy, beautiful and

youthful looking skin.

NIRA Pro provides lasting results to reverse the signs

of aging in as little as 8 to12 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.

Watch the NIRA Pro Instructional Video:

www.niraskin.com/pages/

how-to-use-nira-pro

CONTENTS

HOW TO USE ......................................................................................................................................................2

APPLICATION GUIDELINES...................................................................................................................................4

WHO SHOULD USE, WHEN TO USE, WHAT TO EXPECT ........................................................................................7

SAFETY INFORMATION ........................................................................................................................................8

CHARGING INSTRUCTIONS ...............................................................................................................................10

TROUBLESHOOTING ..........................................................................................................................................11

CLEANING, STORAGE, SERVICE, AND MAINTENANCE ......................................................................................12

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

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

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

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

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

NIRA Pro is a skin rejuvenating device intended to reduce facial wrinkles*

•All skin types and tones from light to dark.

WHO CAN USE

•When the face is fully clean and dried.

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

•Use NIRA Pro daily. For accelerated results repeat twice daily, but do not apply more than twice within a 1-hour period.

WHEN TO USE

•Use daily for 90 days or more to achieve good, long-lasting results.

•Always use NIRA Pro on clean and dry skin.

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

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

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

•You should start to see lasting wrinkle improvements within 60 days of regular use. You should see good, lasting results within 90 days of use.

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

session (10 pulses per eye) in 1 minute.

•Immediately after application, 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 application. If you ﬁnd it uncomfortable, reduce the power levels in subsequent sessions.

WHAT TO EXPECT

HOW TO ACHIEVE THE BEST RESULTS

*NIRA Pro is clinically proven to reduce wrinkles around the eyes. NIRA Pro is Model 2 of Dermal Photonics Corporation, Massachusetts, USA.

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 to using NIRA Pro. Only use the Medical grade/electrical safety certiﬁed charger and supplied USB-C cord to recharge the device. Using an

uncertiﬁed 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.

NIRA Pro 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 NIRA Pro 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 NIRA Pro in the supplied box in a secure location

away from household animals and children.

SAFETY INFORMATION - WARNINGS

Do not use NIRA Pro if the device or the charger is visibly damaged. Never attempt to open or repair the device; 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 application.

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. 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.

CAUTION: Performance of the procedures other than those speciﬁed herein may result in hazardous radiation exposure.

SAFETY INFORMATION - WARNINGS

•To prevent serious injury, you must follow these Instructions for Use when using NIRA Pro.

•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 apply after long-term UV exposure. Sunburned 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 application.

•NIRA Pro 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 application 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 application tip are dry before application. The device may not operate properly if the application tip is wet. Such failure to operate

properly may cause serious side effects or device malfunction.

•Do not share NIRA Pro 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 USB-C cable provided.

•Use only with a Medical grade/electrical safety certiﬁed charger. AC input 110 V/60 Hz (or 100-240 V/50-60 Hz) and DC output 5 V current 1 A

or more.

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 a 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 40 mins of continuous use. This equates to 3 days of daily usage between charges. This time will vary with

•settings and will lessen as the battery ages.

•Your NIRA Pro will not work when it is plugged into the battery charger. Unplug your NIRA Pro to begin application.

Note: Application is disabled during charging.

Accessories:

Micro USB 2.0 Type C Cable, AC input 110 V/60 Hz (or 100-240 V/50-60

Hz) and DC output 5 V current 1 A or more Fixed Blade Wall Plug-in Power

Supply (not supplied in the SKU)

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 use.

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

Battery Indicators

B—Bottom LED

T—Top LED 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

BB-TTT-BB-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

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..

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 Support.

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.

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

NIRA Pro 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

NIRA Pro 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

TRAVEL

If traveling with NIRA Pro, 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. Make sure that your charger can operate between 100 – 240 VAC and 50 – 60 Hz. You may need a wall plug adapter

or different wall plug blades to charge NIRA Pro 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

NIRA Pro 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 activate the laser.

Complies with FDA performance standards for laser products except for conformance with CENELEC EN 60825-1:2014 + A11:2021 A11:2021)

Speciﬁcations

Wavelength 1450nm (+/- 20nm)

Pulse Duration 3.0 s

Maximum Power Output 2.0 W

The laser radiation hazard label can be afﬁxed to the

product aperture but it is supplied here:

LASER RADIATION

FOLLOW INSTRUCTIONS

CLASS 1C LASER PRODUCT

EUROPEAN AUTHORIZED REPRESENTATIVE EC I REP

Obelis s.a., Bd General Wahis 53, 1030 Brussels, Belgium

Tel: +(32)2.732.59.54

Fax: +(32)2.732.60.03

Email: [email protected]

UNITED KINGDOM AUTHORIZED REPRESENTATIVE UK I REP

Obelis UK Ltd., Sandford Gate, Oxford, OX4 6LB, United Kingdom

Tel: +44.1491.378012

Email: [email protected]

EMC INFORMATION

NIRA Pro needs special precautions regarding EMC and needs to be installed according to EMC information.

Caution: Mobile RF communications equipment can affect NIRA Pro.

Warnings: The use of accessories and cables other than those speciﬁed in this document may result in increased emissions or decreased immunity of NIRA Pro.

Warnings: NIRA Pro should not be used adjacent to or stacked with other equipment during application. 

Electromagnetic Emissions Declaration

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

RF emissions CISPR 11 Group 1 NIRA Pro 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

NIRA Pro is suitable for use in all establishments, including domestic establishments and those directly con-

nected 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

NIRA Pro is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of NIRA Pro 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, com-

mercial 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 com-

mercial 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, com-

mercial or

hospital environment.

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

Electromagnetic Immunity Declaration

NIRA Pro 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 NIRA

Pro 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 trans-

mitter 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 NIRA Pro is used exceeds the applicable RF compliance level above, NIRA Pro should be observed to verify normal operation. If abnormal performance is observed, additional measures may be

necessary, such as reorienting or relocating NIRA Pro.

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 NIRA Pro

NIRA Pro is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of NIRA Pro can help prevent elec-

tromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and NIRA Pro 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.