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User manual 820-001 G NIRA BEAUTY WRINKLES ACNE IFU | Users Manual | 1.36 MiB | ||||
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1 | User manual 820-001 G NIRA BEAUTY WRINKLES ACNE IFU | Users Manual | 1.36 MiB |
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, betterlooking 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. As we age, the productio n of collagen slows, which can result in wrinkles and imperfections, especially around the eyes. The NIRA BEAUTY Skincare Laser is specially designed to bo ost collagen stores and rejuve-
nate skin cells for the healthy, beautiful skin you deserve. The NIRA BEAUTY Skincare Laser provides lasting results* to reverse the signs of aging using advanced dermatologist -tested technology to produce noticea-
ble results in as little as 8 to 12 weeks. 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.
*based on clinical results with 3-months post-treatment observations Watch the NIRA Beauty Instructional Video at:
www.nirabeauty.com/video 2 CONTENTS SYMBOLS .......................................................................................................................................................................................................................................................................................... 4 ABOUT NIRA BEAUTY SKINCARE LASER ........................................................................................................................................................................................................................................... 5 SAFETY INFORMATION..................................................................................................................................................................................................................................................................... 6 POTENTIAL SIDE EFFECTS ................................................................................................................................................................................................................................................................. 8 WHO SHOULD USEWRINKLES ...................................................................................................................................................................................................................................................... 9 CHARGING INSTRUCTIONS.............................................................................................................................................................................................................................................................10 PRE-USE INSTRUCTIONS.................................................................................................................................................................................................................................................................11 RECOMMENDED USE INSTRUCTIONS ............................................................................................................................................................................................................................................12 WHAT TO EXPECT AND ACHIEVING BEST RESULTS .......................................................................................................................................................................................................................13 CLINICAL STUDY .............................................................................................................................................................................................................................................................................14 USER EXPERIENCE..15 CLEANING, STORAGE, SERVICE, AND MAINTENANCE ...................................................................................................................................................................................................................16 LABELS AND SPECIFICATIONS ........................................................................................................................................................................................................................................................17 TRAVEL AND DISPOSAL ..................................................................................................................................................................................................................................................................18 TROUBLESHOOTING .......................................................................................................................................................................................................................................................................19 EMC INFORMATION .......................................................................................................................................................................................................................................................................20 GLOSSARY.......................................................................................................................................................................................................................................................................................24 CONTACT INFORMATION ...............................................................................................................................................................................................................................................................25 3 SYMBOLS The following symbols are used within this manual or on the NIRA BEAUTY Skincare Laser and its packaging:
IP22 Consult Instruction For Use Protection against finger-sized objects. Protected against drip-
ping water. The device is not submersible. Type BF Applied Part Temperature Range Relative Humidity Range Pressure Range Serial Number Date of Manufacture Fragile, Handle with Care Keep Dry Caution see Safety Information in this document Standby & Ready Class II Double Insulation Electrical Appliance Non-ionizing Radiation Use only with NIRA BEAUTY Supply Unit Read Operators Manual Laser Radiation Warning WARNING: Do not use this appliance near bathtubs, showers, basins or other vessels containing water. 4 ABOUT NIRA BEAUTY SKINCARE LASER Laser Aperture Treatment Button Company Logo Icon Power Level Indicator Power On & Power Select Battery & Error Indicators USB & Charging Port Pulse Strength Low to High 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 wrinkleswrinkles 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. Do not use if you are pregnant, nursing or undergoing fertility treatments. Do not use if have a history of skin cancer, or any other type of cancer, or pre-malignant moles. Do not use if you have any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash and rosacea. 6 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 users 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. Avoid sun tanning bed exposures and apply SPF 30 or greater when outside within 6 weeks of treatment. The NIRA BEAUTY Skincare Laser 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 adolescents 12 and over. Do not point or place the treatment 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. Always keep the cord away from heated or wet surfaces to prevent damage to the device. Ensure the skin and treatment tip are dry before treatment. The device may not operate properly if the treatment tip is wet. Such failure to operate properly may cause serious side effects or device malfunction. 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. Use only with the power supply unit and USB cable provided. 7 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. 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. 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 using the NIRA BEAUTY Skincare Laser. Only use the charger and USB cord supplied to recharge the device. Using a different charger or USB cord could cause device malfunction or serious injury. Do not drop the device on hard surfaces as the device could be damaged. The NIRA BEAUTY Skincare Laser 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 the NIRA BEAUTY Skincare Laser 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 on page 16. Store the NIRA BEAUTY Skincare Laser in the supplied box in a secure location away from household animals and children. POTENTIAL SIDE EFFECTS Side effects that may appear include: skin warmth, redness and stinging. Rarer 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. 8 WHO SHOULD USE NIRAWRINKLES 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 wrinkleswrinkles 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. 50 pulses per eye area are recommended. Use a mirror when treating around the eyes. See the illustration to the right for clear treatment area definition. If you would like to accelerate your results, we recommend waiting 1 minute and retreating each area. Do not treat more than twice within a 1 hour period. 9 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. 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. 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. A fully charged device will last approximately 4 hours of continuous use. This time will vary with settings and will lessen as the battery ages. Battery Indicators Charger State Condition Note: Treatment is disabled during charging. Charger disconnected Charger connected Top is ON Bottom is ON Top is OFF Bottom is ON Normal operationBattery over half charge Normal operationBattery less than half charge Top is OFF Bottom is Blinking Very low charge. May stop functioning. Top is OFF Bottom is Blinking Still charging. Less than half charge. Top is Blinking Bottom is ON Top is ON Bottom is ON Still charging. More than half charge. Charge complete. Discon-
nect and treat. 10 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 sensa-
tion experienced at each level. We recommend starting at the lowest level. Press the Laser Aperture fully against the skin, then press the Treatment Button to fire the laser. Press the power button again to increase power from levels 1 to 5, then back to 1 until you find the highest level that where you feel warmth from the device without pain. This setting will vary by treatment location. Note: you may use different power settings on different parts of your body depending on the sensi-
tivity of the treatment area. For example, areas such as under the eye should be treated starting at the lowest level to test the area then gradually increase the power level if desired. 11 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 TREAT 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. 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. Place the Laser Aperture (Applied Part) flat against the skin then press the Treatment Button. You will hear one high-pitched beep and see the power level lights flashing when the device starts treating. Keep the device tip pressed completely to skin during treatment. If you hear a lower pitch beep when pressing the treatment button or during the treatment, this means the tip does not have complete contact with the skin. If this occurs, lift the tip completely off the skin and reposition the tip and try again. After about one second you will hear another beep and you may move the device tip to the next spot and repeat. Treat the skin in a linear pattern so all areas of interest are treated evenly with slight overlap between pulses. When finished, hold the power button for about 2 seconds to power down the device. The unit will automatically power down after 2 minutes with no activity. It is recommended to clean the exterior of the NIRA BEAUTY Skincare Laser after each use with a damp cloth. Continue with your daily skincare routine. 12 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. If you find it uncomfortable, reduce the power levels in subsequent treatments. During the first month, it is rare, but you may experience some temporary redness. If you treat yourself at night, the redness will diminish while you sleep. Some users may notice that their skin becomes rough and/or dry during the first month of use. Try applying a moisture cream after treatment to help soothe any dryness. You should continue to use moisturizing skincare products during the day. Daily use of a sunscreen with SPF 30 or greater is also recommended. ACHIEVING BEST RESULTS Wash and completely dry treatment areas before using NIRA BEAUTY Skincare Laser. Treat each desired area once each day. During your treatment sessions, use the highest power level where you feel warmth without pain. To lessen possible skin dryness, use a facial moisturizer after each treatment. For the best results, daily usage is recommended for 4 months. After desired results are achieved, you may continue to use device daily to maintain desired results. 13 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 saw 1 full wrinkle scale unit improvement within 5 months 20% of users saw 2 full wrinkle scale units improvement within 5 months 63% of users saw 1 full wrinkle scale unit improvement within 6 months 22% of users saw 2 full wrinkle scale units improvement within 6 months 69% of users saw 1 full wrinkle scale unit improvement within 7 months 36% of users saw 2 full wrinkle scale units improvement within 7 months 10% of users saw 3 full wrinkle scale units improvement within 7 months 81% of users where achieved wrinkle reduction maintained wrinkle improvement for at least 1 month after users stopped using NIRA as rated by 3 independent and blinded professional reviewers. 81% of users where achieved wrinkle reduction maintained wrinkle improvement for at least 2 months after users stopped using NIRA as rated by 3 independ-
ent and blinded professional reviewers. 14 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. Clinical study users were trained on the use of the device. User Experience In a clinical study users of the NIRA Skincare Laser completed anonymous surveys about their experiences and found:
99% of users felt the NIRA Beauty Skincare Laser was easy to use. 87% of users enjoyed using the NIRA Beauty Skincare Laser. 15 Shipping Temperature: 40C to 50C (-40F to 122F) Relative Humidity: 10-100%
Atmospheric Pressure: 50-106 kPa Temperature: 15C to 35C (59F to 95F) Relative Humidity: 30-75%
Atmospheric Pressure: 70-106 kPa ENVIRONMENT CONDITIONS The NIRA BEAUTY Skincare Laser should be used in a comfortable environment. REQUIRED SHIPPING AND STORAGE CONDITIONS The NIRA BEAUTY Skincare Laser should be stored in a dry place at normal room temperature. Storage Temperature: 20C to 35C (-4F to 95F) 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. 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. 16 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 Pulse Duration Maximum Power Output 1450nm (+/- 20nm) 0.8 s 1.8 W this device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operations. FCC ID 2ADZENIRA This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) 2) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the F CC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.. This equipment generates, uses and can rad iate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equip ment off and on, the user is encouraged to try to correct the interference by one of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer of an experienced radio/TV technician for help. 17 TRAVEL If traveling with NIRA BEAUTY Skincare Laser, be sure to pack the device in its original packaging to prevent damage. Always check the countrys 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. 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 follow-
ing:
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 sub-
stances 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. 18 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. BBottom LED TTop LED Description Battery Indicators User Action Reference Code Power lights on but Usage light lowest level blinking All front lights off Normal Replenish Usage Blinking SLOWLY B-T-B-T Blinking FAST B-TT-B-TT Replenish Usage Call DPC Customer Service Front lights not on - can't treat Blinking SLOWLY BB-T-BB-T Turn off NIRA and Turn back on. If not resolved, call Customer Service Blinking SLOWLY at the same time Blinking FAST B-TTT-B-TTT Blinking SLOWLY BB-TT-BB-TT Blinking FAST B-TTTT-B-TTTT Blinking FAST BB-TT-BB-TT Charge NIRA Call DPC Customer Service Call DPC Customer Service Release Treatment button. Call DPC Customer Service Call DPC Customer Service Blinking FAST B-TTTTT-B-TTTTT Release Power button. Call DPC Customer Service 2 3 5 7 8 9 10 11 12 13 19 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. Warning: The charger may be damaged with electrostatic discharge through the air if the discharge voltage will be higher than 8 kV. If the device is not charging when connected to the charger and the cable is properly connected contact the company (information on page 25) and order a new charger. Electromagnetic Emissions 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. RF emissions CISPR 11 Group 1 The NIRA BEAUTY 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. The NIRA BEAUTY is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Class B Complies Complies 20 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 Immunity test IEC 60601test level Electrostatic discharge (ESD) IEC 61000-4-2
+8 kV contact
+8 kV air Electrical fast transient/ burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interrupts and voltage variations on power supply input lines IEC 61000-4-11
+2 kV for power supply lines
+1 kV for input/output lines.
+1 kV differential mode
+2 kV common mode
<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 environment. Compliance level Complies Complies Complies Complies Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Mains power quality should be that of a typical home, commercial or hospital environment. Mains power quality should be that of a typical home commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the NIRA BEAUTY requires continued operation during power mains Interruptions, it is recommended that the NIRA BEAUTY be powered from an uninterrupted power supply or a battery. Power frequency (50/60 Hz) 3 A/m Complies Power frequency magnetic fields should be at levels magnetic field IEC 61000-4-8 characteristic of a typical location in a typical home, commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. 21 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. Immunity IEC 60601 test level Compliance level Electromagnetic environment guidance Electromagnetic Immunity Declaration test 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 the NIRA BEAUTY including cables, tha n the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended sepa ration distance d = 1.17 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 transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b 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. a 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 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. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 22 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. 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. Rated maximum output power of transmitter Separation distance according to frequency of the transmitter W 0,01 0,1 1 10 100 150 kHz to 80 MHz 150 kHz to 80 MHz 150 kHz to 80 MHz M d = 1,17 0,12 0,37 1,17 3,70 11,70 d = 1,17 0,12 0,37 1,17 3,70 11,70 d = 2,33 0,23 0,74 2,33 7,37 23,30 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using equation applicable to the frequency 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. 23 GLOSSARY Inflammatory/lnflamed: Red and sensitive to the touch. Periorbital Wrinkles:
Wrinkles around the eyes. 24 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 Gnral 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.com/video 25
frequency | equipment class | purpose | ||
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1 | 2019-02-18 | 2402 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2019-02-18
|
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1 | Applicant's complete, legal business name |
Dermal Photonics Corporation
|
||||
1 | FCC Registration Number (FRN) |
0028133858
|
||||
1 | Physical Address |
100 Corporate Pl, Suite 303
|
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1 |
Peabody, Massachusetts 01960
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@us.bureauveritas.com
|
||||
1 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ADZE
|
||||
1 | Equipment Product Code |
NIRC
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D******** B********
|
||||
1 | Title |
President and CEO
|
||||
1 | Telephone Number |
78154********
|
||||
1 | Fax Number |
86640********
|
||||
1 |
d******@dermalphotonics.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Skincare Laser | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
BUREAU VERITAS CONSUMER PRODUCTS SERVICES, INC.
|
||||
1 | Name |
S**** L******
|
||||
1 | Telephone Number |
978 6******** Extension:
|
||||
1 | Fax Number |
97848********
|
||||
1 |
s******@us.bureauveritas.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC