Quick Start & Instructions For Use Part number: 820-005, Rev C
NIRA SKINCARE LASER QUICK START 1 Laser Aperture — Delivers Laser Light During Treatments Cleanse your skin with your preferred skin cleanser. Dry your face completely before beginning treatment. 2 Power On & Power Select Button — Turns NIRA laser on/off, adjusts the power levels of the laser Wash & Dry Face Remove all makeup thoroughly.
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.
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.
CONTENTS INSTRUCTION FOR USE .............................................................................................................................................................................................................................. 4 SYMBOLS ....................................................................................................................................................................................................................................................
SYMBOLS The following symbols are used within this manual or on the NIRA Skincare Laser and its packaging: Consult Instruction For Use IP22 Protection against finger-sized objects. Protected against dripping water. The device is not submersible.
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.
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.
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.
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.
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.
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 approximately 1 second apart.
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.
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.
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
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.
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.
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.
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.
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).
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 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.
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.
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.
Dermal Photonics 100 Corporate Pl, Suite 303 Peabody, MA 01960 Customer Care 781-451-1700 info@niraskin.com www.niraskin.
