Instructions For Use Read this completely prior to using your NIRA BEAUTY Skincare Laser Part number: 820-001, Rev G
WELCOME TO NIRA BEAUTY Your journey to beautiful, better–looking skin. The NIRA BEAUTY Skincare Laser is an innovative device for wrinkles skincare treatment, delivering lasting results*, easily a nd conveniently in your own home. With just a few minutes each day, your NIRA BEAUTY Skincare Laser visibly reduces the appearance of fine lines, wrinkl es to restore smooth, radiant skin. Collagen is a protein naturally produced by the body to give skin youthful elasticity and firmness.
CONTENTS SYMBOLS ..........................................................................................................................................................................................................................................................................................4 ABOUT NIRA BEAUTY SKINCARE LASER ..................................................................................................................................................................................
SYMBOLS The following symbols are used within this manual or on the NIRA BEAUTY Skincare Laser and its packaging: IP22 Consult Instruction For Use Serial Number Non-ionizing Radiation Protection against finger-sized objects. Protected against dripping water. The device is not submersible.
ABOUT NIRA BEAUTY SKINCARE LASER Laser Aperture Treatment Button Pulse Strength Low to High Company Logo Icon Power Level Indicator Power On & Power Select Battery & Error Indicators USB & Charging Port Contents: NIRA BEAUTY Skincare Laser, USB cable, wall plug adaptor, plug adaptor blades, Instructions for Use, Quick Reference Guide 5
SAFETY INFORMATION Read all important safety information on pages 7 and 8 prior to using the NIRA BEAUTY Skincare Laser. WHEN TO USE (INDICATIONS) The NIRA Beauty 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.
SAFETY INFORMATION - WARNINGS To prevent serious injury, you must follow these Instructions for Use when using the NIRA BEAUTY Skincare Laser. Changes or modifications not expressly approved by Dermal Photonics Corporation could void the user’s authority to operate the 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 BEAUTY 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.
WHO SHOULD USE NIRA—WRINKLES When used as directed, the NIRA BEAUTY Skincare Laser visibly smoothes and diminishes fine lines and wrinkles around the eyes TREATMENT GUIDELINES - WRINKLES The NIRA BEAUTY Skincare Laser is intended to treat periorbital wrinkles—wrinkles around the eyes. Typically 2-3 rows of treatment are needed for each eye, moving the device slightly lower for each row of use, until the entire area is covered. Overlap each pulse slightly to ensure complete coverage.
CHARGING INSTRUCTIONS First, connect the USB 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 BEAUTY Skincare Laser is connected to a power source, the battery indicator lights will flash until the battery is fully charged.
PRE-USE INSTRUCTIONS Be sure battery is charged. If the battery is charged, unplug battery charger prior to use. The NIRA BEAUTY Skincare Laser will not operate while the device is connected to the USB. Turn on the device by pressing the power button located on the lower end of the device. You may wish to test on your forearm and adjust power setting to get familiar with the sensation experienced at each level. We recommend starting at the lowest level.
RECOMMENDED USE INSTRUCTIONS Before using the NIRA BEAUTY Skincare Laser read the entire Instructions for Use booklet. You may also wish to watch the instructional video at www.nirabeauty.com/ video. PREPARE Cleanse your skin with your preferred skin cleanser. Dry your face thoroughly before you begin treatment. If your skin is already clean and dry, you can skip this step. TREAT Turn on your NIRA BEAUTY Skincare Laser by pressing the power button once.
WHAT TO EXPECT Treatment with the NIRA BEAUTY Skincare Laser is easy when you know what to expect. The first treatment session is usually the longest, so it's best to start when you have more time. Within a few uses, most users complete a full treatment around the eyes in 2 - 3 minutes for wrinkle treatment. 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.
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 units improvement within 3 months 59% of users saw 1 full wrinkle scale unit improvement within 4 months 17% of users saw 2 full wrinkle scale units improvement within 4 months 57% of users
68% of users where achieved wrinkle reduction maintained wrinkle improvement for at least 3 months after users stopped using NIRA as rated by 3 independent and blinded professional reviewers. Side effects that may appear include: skin warmth and stinging. Less frequent side effects 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.
ENVIRONMENT CONDITIONS The NIRA BEAUTY 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 BEAUTY Skincare Laser should be stored in a dry place at normal room temperature.
LABELING AND SPECIFICATIONS The NIRA BEAUTY Skincare Laser is a Class 1 laser operating at the specifications listed in the table below. The laser aperture integrates a touch sensor requiring contact in order to treat. Specifications Wavelength 1450nm (+/- 20nm) Pulse Duration 0.8 s Maximum Power Output 1.8 W FCC ID 2ADZENIRA This device complies with Part 15 of the FCC Rules.
TRAVEL If traveling with NIRA BEAUTY 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 when traveling abroad.
TROUBLESHOOTING Refer to this table if you are having problems operating the device. If you still have questions, please visit www.nirabeauty.com or call NIRA Customer Service at 781-451-1700.
EMC INFORMATION The NIRA BEAUTY Laser needs special precautions regarding EMC and needs to be installed according to EMC information. Caution: Mobile RF communications equipment can affect the NIRA BEAUTY 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 Laser. Warnings: The NIRA Laser should not be used adjacent to or stacked with other equipment treatments.
Electromagnetic Immunity Declaration The NIRA BEAUTY is intended for use in the electromagnetic environment specified below. The customer or the user of the NIRA BEAUTY should assure that it is used in such an environment.
Electromagnetic Immunity Declaration The NIRA BEAUTY is intended for use in the electromagnetic environment specified below. The customer or the user should assu re that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the NIRA BEAUTY The NIRA BEAUTY is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
GLOSSARY Inflammatory/lnflamed: Periorbital Wrinkles: Red and sensitive to the touch. Wrinkles around the eyes.
QUESTIONS? Our Dermal Photonics Corporation Customer Care representatives are available to help. Contact us at: Dermal Photonics Customer Care 5 Elm Street, Suite 10 Danvers, MA 01923 Phone: 781-451-1700 Email: info@nirabeauty.com Or visit www.nirabeauty.com European Authorized Representative Obelis s.a Boulevard Général Wahis 53 1030 Brussels, BELGIUM Phone: +(32) 2.732.59.54 Fax: +(32) 2.732.60.03 E-Mail: mail@obelis.net Watch the NIRA Beauty Instructional Video at: www.nirabeauty.
