Nira Skincare Laser Instructions For Use Manual
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Instructions For Use
Read this completely prior to using your NIRA BEAUTY Skincare Laser
Part number: 820-001, Rev G

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Summary of Contents for Nira Skincare Laser

  • Page 1 Instructions For Use Read this completely prior to using your NIRA BEAUTY Skincare Laser Part number: 820-001, Rev G...
  • Page 2 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.
  • Page 3: Table Of Contents

    CONTENTS SYMBOLS .......................................................... 4 ABOUT NIRA BEAUTY SKINCARE LASER ................................................5 SAFETY INFORMATION..................................................... 6 POTENTIAL SIDE EFFECTS ....................................................8 WHO SHOULD USE—WRINKLES ..................................................9 CHARGING INSTRUCTIONS.....................................................10 PRE-USE INSTRUCTIONS....................................................11 RECOMMENDED USE INSTRUCTIONS ................................................12 WHAT TO EXPECT AND ACHIEVING BEST RESULTS ............................................13 CLINICAL STUDY ......................................................14...
  • Page 4: Symbols

    SYMBOLS The following symbols are used within this manual or on the NIRA BEAUTY Skincare Laser and its packaging: Non-ionizing Radiation Serial Number Consult Instruction For Use Use only with NIRA BEAUTY Supply Date of Manufacture Protection against finger-sized IP22 Unit objects.
  • Page 5: About Nira Beauty Skincare Laser

    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...
  • Page 6: Safety Information

    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.
  • Page 7 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 BEAUTY Skincare Laser with other people. Sharing the device could transfer bacteria or other pathogens from one person to another and may cause harmful infection.
  • Page 8: Potential Side Effects

    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.
  • Page 9: Who Should Use-Wrinkles

    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.
  • Page 10: Charging Instructions

     When your NIRA BEAUTY Skincare Laser is connected to a power source, the battery indicator lights will flash until the battery is fully charged. Once the battery is fully charged, the battery indicator lights will stop flashing. It should take no longer than 5 hours to fully charge the device.
  • Page 11: 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.
  • Page 12: Recommended Use Instructions

     Turn on your NIRA BEAUTY Skincare Laser by pressing the power button once. You will hear a high-pitched beep and the lights will turn on. Press the power button again to increase the power level to the desired strength. Use the highest power level where you feel warmth without pain.
  • Page 13: What To Expect And Achieving Best Results

    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.
  • Page 14: Clinical Study

    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 ...
  • Page 15: User Experience

     68% of users where achieved wrinkle reduction maintained wrinkle improvement for at least 3 months after users stopped using NIRA as rated by 3 independ- ent 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.
  • Page 16: Cleaning, Storage, 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 mainte- nance, please call Dermal Photonics Corporation. The NIRA BEAUTY Skincare Laser will operate for more than one year of rec- ommended use.
  • Page 17: Labels And Specifications

    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 con- tact in order to treat. Specifications Wavelength 1450nm (+/- 20nm) Pulse Duration 0.8 s...
  • Page 18: Travel And Disposal

    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.
  • Page 19: Troubleshooting

    B-T-B-T please visit www.nirabeauty.com or call NIRA Customer Service at 781-451-1700. Blinking FAST Call DPC Customer Service B-TT-B-TT Turn off NIRA and Turn back on. If not resolved, Blinking SLOWLY B—Bottom LED BB-T-BB-T call Customer Service T—Top LED Blinking SLOWLY...
  • Page 20: 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.
  • Page 21 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. Immunity test IEC 60601test level Compliance level Electromagnetic environment –...
  • Page 22 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 BEAUTY is used exceeds the applicable RF compliance level above, the NIRA BEAUTY should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NIRA BEAUTY.
  • Page 23 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. The customer or the user of the NIRA BEAUTY can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equ ipment (transmitters) and the NIRA BEAUTY as recommended below, according to the maximum output power of the communications equipment.
  • Page 24: Glossary

    GLOSSARY Inflammatory/lnflamed: Red and sensitive to the touch. Periorbital Wrinkles: Wrinkles around the eyes.
  • Page 25: Contact Information

    Obelis s.a 5 Elm Street, Suite 10 Boulevard Général Wahis 53 Danvers, MA 01923 1030 Brussels, BELGIUM Phone: 781-451-1700 Phone: +(32) 2.732.59.54 Email: info@nirabeauty.com Fax: +(32) 2.732.60.03 Or visit www.nirabeauty.com E-Mail: mail@obelis.net Watch the NIRA Beauty Instructional Video at: www.nirabeauty.com/video...

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