Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for Nira 820-005
Summary of Contents for Nira 820-005
- Page 1 Quick Start & Instructions For Use Part number: 820-005, Rev C...
- Page 2 Push to fire laser for treatment Power On Device Turn on device by pressing the power button for roughly 1 second. NIRA Star Logo — Identify the reject tone: While holding the device in front of you and Indicates Laser Device is on Power Level Setting —...
- Page 3 Repeat this process for the opposite eye. Power down the device by holding down the power button until the NIRA logo and CAUTION: Be sure to move the NIRA to a new spot for each treatment. If you power level lights turn off.
-
Page 4: Instruction For Use
As we age our bodies naturally stop producing collagen that causes wrinkles and sagging of the skin. The NIRA Skincare Laser reverses the im- pact 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. -
Page 5: Table Of Contents
CONTENTS INSTRUCTION FOR USE .............................................. 4 SYMBOLS ..................................................6 USER EXPERIENCE AND SAFETY INFORMATION ......................................7 POTENTIAL SIDE EFFECTS ............................................9 WHO SHOULD USE, WHEN TO USE, ACHIEVING BEST RESULTS, WHAT TO EXPECT ..........................10 PRE-TREATMENT INSTRUCTIONS ..........................................11 TREATMENT GUIDELINES ............................................12 CHARGING INSTRUCTIONS ............................................ -
Page 6: Symbols
SYMBOLS The following symbols are used within this manual or on the NIRA Skincare Laser and its packaging: Non-ionizing Radiation Consult Instruction For Use Serial Number Protection against finger-sized ob- Date of Manufacture IP22 Use only with NIRA Supply Unit jects. -
Page 7: User Experience And Safety Information
Do not use if you have any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosace a. REGULATORY COMPLIANCE NIRA Skincare Laser is FDA Cleared for home use for periorbital wrinkles (wrinkles around the eye) and is CE marked for the s ame. - Page 8 Do not share the NIRA Skincare Laser with other people. Sharing the device could transfer bacteria or other pathogens from on e person to another and may cause harmful infection. Use only with the power supply unit and USB-C cable provided.
-
Page 9: Potential Side Effects
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. -
Page 10: Who Should Use, When To Use, Achieving Best Results, What To Expect
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. ACHIEVING BEST RESULTS ... -
Page 11: Pre-Treatment Instructions
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. Step Four ... -
Page 12: Treatment Guidelines
Illustration of treatment pattern 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 yo ur skin may build up to a point where you feel discomfort or pain. This is not recommended and should be avoided. - Page 13 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 ...
-
Page 14: Charging Instructions
When your NIRA Skincare Laser is connected to a power source, the battery indicator lights will flash until the battery is fu lly charged. 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. -
Page 15: Clinical Study Results
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 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 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. -
Page 17: Labels And Specifications
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... -
Page 18: Travel And Disposal
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. -
Page 19: Troubleshooting
Replenish Usage B-T-B-T lowest level blinking Blinking FAST B-TT-B-TT Call NIRA Customer Service Turn off NIRA and Turn back on. If not resolved, call Blinking SLOWLY BB-T-BB-T Customer Service Blinking SLOWLY Charge NIRA by plugging into electrical outlet at the same time... -
Page 20: Emc Information
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. - Page 21 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 –...
- 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 Skincare Laser is used exceeds the applicable RF compliance level above, the NIRA Skincare Laser should be obs erved to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NIRA Skincare Laser.
- Page 23 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. The customer or the user of the NIRA Skin- care Laser can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF com munications equipment (transmitters) and the NIRA Skincare Laser as recommended below, according to the maximum output power of the communications equipment.