TABLE OF CONTENTS INTRODUCTION... 3 PRODUCT DESCRIPTION... 3 SPECIFICATIONS... 4 GENERAL WARNINGS LED (LIGHT EMITTING DIODE)...

Transcription

1 Instruction Manual

2 TABLE OF CONTENTS INTRODUCTION PRODUCT DESCRIPTION SPECIFICATIONS GENERAL WARNINGS General Precautions General Instructions General Preparation for Use LED (LIGHT EMITTING DIODE) Guide for Use for the LED Mode Contraindications for the LED Mode Warnings for the LED Mode Precautions for the LED Mode Risks for the LED Mode Benefits for the LED Mode Preparation for Use for the LED Mode INSTRUCTIONS, DIRECTIONS FOR USE, & OPERATING INSTRUCTIONS FOR THE LED MODE. 9 When to Seek Medical Assistance for the LED Mode Alternative Procedures and Treatments for the LED Mode ULTRASONIC Guide for Use for the Ultrasonic Mode Contraindications for the Ultrasonic Mode Warnings for the Ultrasonic Mode Precautions for the Ultrasonic Mode Risks for the Ultrasonic Mode Benefits for the Ultrasonic Mode Preparation for Use for the Ultrasonic Mode INSTRUCTIONS, DIRECTIONS FOR USE, & OPERATING INSTRUCTIONS FOR THE ULTRASONIC MODE. 13 IMPORTANT INFORMATION INDICATIONS FOR USE Glossary After Use Information Troubleshooting Home & Mobile Environment Travel with Device Warranty Information

3 ON/OFF INTRODUCTION Thank you for purchasing the Truth Vitality Lux Renew LED and ultrasonic device. Please read these instructions before use and keep them in a safe place for future reference. The Lux Renew is designed for normal skin. Please consult your medical practitioner if you have any specific skincare concerns or conditions. PRODUCT DESCRIPTION The Lux Renew consists of two major components, the hand piece, which contains the functional elements of the device, and the power adaptor. Protective goggles are provided as an accessory to the device. The Lux Renew has two functional modes; LED and ultrasonic. Multiple types of treatments are available using the Lux Renew. Each of the treatments is linked to a particular mode of the Lux Renew. The LED mode has two colors available, red and blue. The ultrasonic mode uses ultrasound for anti-aging and to relieve minor muscle aches and pains. The ultrasonic mode of Lux Renew has five levels of intensity. Treatment head LED light Power Adapter LCD display Control panel SHIFT MODE CFM LCD display Control panel 3

4 SPECIFICATIONS Type BF applied part. IPX0 The Lux Renew is considered IPX0 for ingress protection as defined by IEC Attention, consult accompanying documents. Consult instructions for use. Only use with Class II ungrounded power adaptor Kuantech KSAS7R D5 Adaptor input power: AC V Adaptor output power: 15V, 400mA Ultrasonic frequency: 3 MHz ± 5% Storage Conditions -25 C to 55 C 10% - 85% humidity, Non-condensing Altitude < 8000 ft Transportation The unit should be protected against vibration and shock during transportation. Operating Environment 10 C - 35 C 30% - 75% humidity, Non-condensing Altitude < 8000 ft. 4

5 GENERAL WARNINGS If you are in the care of a physician, consult with your physician before using this device. Do not use if pregnant. Do not share the Lux Renew with another user due to the possibility of transferring bacteria/diseases. Do not use the Lux Renew for longer than 20 minutes continuous use. TO REDUCE THE RISK OF FIRE, ELECTRIC SHOCK OR PERSONAL INJURY: Do not place or store the device where it can fall or be pulled into a tub or sink. Do not place in or drop into water or other liquid. Keep all electrical appliances away from water (including bath and shower). If the device accidentally falls in water unplug immediately. Turn off and unplug device before cleaning. Do not operate the unit if the cord or unit has been damaged. Electric shock could occur. Do not attempt to use alternate power supplies. Inspect this device prior to each use. Check for damage. Operate, transport and store the Lux Renew per the manner specified in this manual. No user serviceable parts. Do not attempt to disassemble the Lux Renew. This may cause the device to be damaged, malfunction or may cause personal injury. Stop immediately if you experience any adverse effect or have a concern regarding use. Contact your healthcare provider. Do not operate this device in an environment where other devices, which intentionally radiate electromagnetic energy in an unshielded manner, are being used. Portable or mobile Radio Frequency communication equipment can affect medical electrical equipment. GENERAL PRECAUTIONS This product should not be used in the presence of flammable anesthetics. Read all instructions before using your Lux Renew. Failure to do so may result in failure to understand safety information or how the device is used. Inspect this device prior to each use. Check for damage. Damage includes cracks in the device, frayed wires, buttons not present, or a broken display. Failure to do so may result in improper functioning of the device. Do not place device near any heat sources such as radiators, heat registers, stoves or other apparatus that produce heat. Keep the cord away from heated surfaces. Operate, transport and store the device per manner specified in this manual. Failure to do so may result in damage to the unit. GENERAL INSTRUCTIONS There are four buttons: ON/OFF; MODE (to select Sonic, Photon or Time); SHIFT (to choose intensity or time); and CFM (CONFIRM) to start. To adjust the time of your session: Press MODE repeatedly until Time is selected (it will flash). Press SHIFT to adjust Time from 1 19 minutes. Press CFM to start your session. The Lux Renew will turn off automatically after the selected treatment time is completed. GENERAL PREPARATION FOR USE Plug the power adapter into bottom of your Lux Renew hand piece and then into a power outlet. The power jack should fit snugly into the hand piece. Use only the power adaptor that comes with your Lux Renew. If you lose the power adaptor or it is damaged, contact us at customerservice@truthinaging.com for a new one. Use on a clean face, without makeup. Men should shave before treatment, as hair can interfere with the treatment. The facial area under a beard or mustache cannot be treated. Use the Lux Renew in front of a mirror in a well lit room. 5

6 LED (Light Emitting Diode) GUIDE FOR USE FOR THE LED MODE Wrinkle treatment (Red LED) The Lux Renew is an over-the-counter device designed to treat periorbital and facial wrinkles. If you have fine lines radiating out from the corner of your eyes, which are also frequently referred to as crow s feet, the Lux Renew can be used. WRINKLE TYPE ILLUSTRATION DESCRIPTION OF CONDITION LUX RENEW USE Periorbital Lines or crow s feet radiating from corner of eyes Yes Nasolabial Lines running from outer nose to outer lip Yes Forehead Horizontal lines across forehead and 11 lines between eyebrows Yes Lip Vertical lines above and below the lips Yes Marionette Vertical lines from outer corners of mouth to jowls Yes Jowl and Neck Sagging jowl and neck Yes 6

7 Acne treatment (Blue & Red LEDs) The Lux Renew is an over-the-counter device designed to treat mild or moderate inflammatory acne. There are clinically defined levels of acne. The definitions below are provided as a guide for you to determine if this device is right for you. Dermatologists are specialized in the treatment of acne and should be consulted for an assessment of acne. This device is not intended for severe acne. ACNE TYPE ILLUSTRATION DESCRIPTION OF CONDITION LUX RENEW USE No acne Total absence of blemishes and acne Not necessary Mild acne Fewer than 20 whiteheads or blackheads, fewer than 15 inflamed bumps, or fewer than 30 total lesions. Yes Moderate acne 20 to 100 whiteheads or blackheads, 15 to 50 inflamed bumps, or 30 to 125 total lesions. Yes Severe acne More than 100 whiteheads or blackheads, or more than 50 inflamed bumps, or more than 125 lesions, or more than 5 cysts. No. Consult a dermatologist for recommended treatment. 7

8 CONTRAINDICATIONS FOR THE LED MODE Do not use: If you have dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated. If you have eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated. Wait for the effected area to heal before using Lux Renew. If you have abnormal skin conditions caused by diabetes or other systemic or metabolic diseases. If you are currently or have recently been treated with Alpha-Hydroxy Acids (AHAs), Beta-Hydroxy (BHAs), Retin-A, topical retinoids or azelaic acid. If you have been treated with Accutane (isotretinoin) within the past 6 months. If you have been on a steroid regimen within the past 3 months. If you have a history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventive treatment before using Lux Renew. If you have non-inflammatory blackheads or whiteheads. WARNINGS FOR THE LED MODE Do not use this product if you are taking any medications or topical creams that are known to cause photosensitivity. If you are unsure if medication you are taking may cause a light sensitive reaction, contact your healthcare provider before using this product. Do not use over topical steroids or a recent steroid injection. Doing so may result in a photosensitive reaction. Do not use this device over any lesion other than mild to moderate inflammatory acne. Do not use if you have severe acne. Do not use with a topical product that induces heat. Do not use over the thyroid gland (neck area) if you suspect a thyroid issue. Do not look directly at the light source while it is in operation. PRECAUTIONS FOR THE LED MODE Use with the protective goggles provided. This product is not intended to treat non-inflammatory blackheads or whiteheads. RISKS FOR THE LED MODE Individuals taking medications that cause photosensitivity cannot use the Lux Renew. The product can cause these individuals redness, rashes or burning. Individuals that are photoreactive and not taking medications that cause photosensitivity will also experience redness, rashes or burning. Patients with severe acne cannot use this device. Their acne will not improve with use of this device. BENEFITS FOR THE LED MODE Wrinkle treatment (Red LED) The benefit of treatment with the red LED is the reduction of facial fine lines and wrinkles and in the periorbital area (crow s feet). Acne treatment (Blue & Red LED) The benefit of treatment with the blue and red LED is the reduction of inflammatory acne. 8

9 DIRECTIONS FOR USE PREPARATION FOR USE FOR THE LED MODE Some people are sensitive to light. If you are one of these people the Lux Renew may not be suitable for you. To determine if you are sensitive to light, we recommend that you carry out a test on your forearm. Following the operation instructions to turn on the red LEDs, place the treatment head of the Lux Renew in contact your upper forearm and leave in position for 19 minutes. You should NOT experience any adverse reaction during the next 24 hours. An adverse reaction is any pain or discomfort in the treatment area or any skin redness that lasts for longer than 24 hours. If after 24 hours you have not experienced an adverse reaction to the red light, repeat the test on the other forearm BUT this time using the blue light. If after 24 hours you have not experienced an adverse reaction to the blue light it is safe for you to use the Lux Renew. Connect the hand piece to the power adaptor, then connect the power adaptor to a power outlet. Press the ON/OFF button. There will be a beep and the LCD display will show functions and time of use (default time of 15 minutes will display). INSTRUCTIONS, DIRECTIONS FOR USE, & OPERATING INSTRUCTIONS FOR THE LED MODE Wrinkle treatment (Red LED) Typical wrinkle treatment areas are around the eyes, neck, forehead and cheeks. A single session for wrinkle reduction usually takes minutes in which you should gently glide the Lux Renew hand piece slowly over the desired treatment area. 9

10 Initial wrinkle reduction treatment plan: For the first month (4 weeks), treatment should be performed 3 to 5 times a week for minutes each time. Perform the treatment for 5-7 minutes on each area. With your Lux Renew switched on, press MODE repeatedly to select Time in the display (it will flash). When Time is flashing, press SHIFT repeatedly to adjust the time of your treatment to 19 minutes. Press MODE repeatedly to select Photon in the display. Put on the goggles provided with the device. Ensure that the goggles are fitting snugly. Press SHIFT to select the red LED. The red LED will light when selected. Press CFM to start your session. Hold the device up against your skin. Apply light pressure while slowly moving the Lux Renew hand piece in small circular motions over the treatment area. The Lux Renew will switch off automatically after the selected treatment time is completed. You may immediately switch it on again if you wish to continue your session in a different treatment area. Wrinkle reduction maintenance plan: Use Lux Renew three to five times a week for minutes. What to expect when treating with Lux Renew: After each Lux Renew session you may notice a slight reddening of the skin (mild erythema) over the treated area. This is normal and should fade within an hour or two. Best results can be expected 3-7 weeks after completing the recommended course of treatment. Acne treatment (Blue & Red LED) The treatment program consists of 8 treatment sessions spread over 4 weeks, 2 treatments a week. Use the blue light on the first treatment session; wait 2 days, then use the red light. Repeat this for the next 3 weeks. Refer to the table below. Note: If you are treating multiple areas; each area must be exposed to the light for the full 19 minutes. Forearm test 1 (recommended) If no adverse reaction within 24 hours, continue with test 2 19 minutes RED light Forearm test 2 (recommended) If no adverse reaction within 24 hours, start treatment regime Treatment 1 Week 1, first day (Day 1) Treatment 2 Two days later (Day 3) Treatment 3 Week 2, first day (Day 8) Treatment 4 Two days later (Day 10) Treatment 5 Week 3, first day (Day 15) Treatment 6 Two days later (Day 17) Treatment 7 Week 4, first day (Day 22) Treatment 8 Two days later (Day 24) 19 minutes BLUE light 19 minutes BLUE light on EACH AREA 19 minutes RED light on EACH AREA 19 minutes BLUE light on EACH AREA 19 minutes RED light on EACH AREA 19 minutes BLUE light on EACH AREA 19 minutes RED light on EACH AREA 19 minutes BLUE light on EACH AREA 19 minutes RED light on EACH AREA 10

11 With your Lux Renew switched on, press MODE repeatedly to select Time in the display (it will flash). When Time is flashing, press SHIFT repeatedly to adjust the time of your treatment to 19 minutes. Press MODE repeatedly to select Photon in the display. Put on the goggles provided with the device. Ensure that the goggles are fitting snugly. Press SHIFT repeatedly to select the blue or red LED. The chosen LED will light when selected. Press CFM to start your session. Apply light pressure while slowly moving the Lux Renew hand piece in small circular motions over the treatment area. Hold the device up against your skin. The Lux Renew will switch off automatically after the selected treatment time is completed. You may immediately switch it on again if you wish to continue your session in a different treatment area. What to expect when treating with Lux Renew: After each Lux Renew session you may notice a slight reddening of the skin (mild erythema) over the treated area. This is normal and should fade within an hour or two. Best results can be expected 4-8 weeks after completing the recommended course of treatment. WHEN TO SEEK MEDICAL ASSISTANCE FOR THE LED MODE If you are experiencing prolonged redness or sensitivity of the treatment area, discontinue use and consult a healthcare provider. If you are unsure of the type of acne which you may have, are currently being treated for acne or have a history of sensitivity to acne treatments, you should consult your healthcare provider or dermatologist before using the device. If you are unsure if the medication you are taking may cause a light sensitive reaction, contact your healthcare provider. If you are experiencing any adverse effect or have a concern regarding use, discontinue use and contact your physician. ALTERNATIVE PROCEDURES AND TREATMENTS FOR THE LED MODE Topical lotions and gels can be used to treat mild to moderate acne. The use of topical solutions can result in discoloration or bleaching of fabrics, towels and wash cloths. A dermatologist must be consulted in order to obtain prescription medications. In addition to providing effective medications for acne treatment, a qualified dermatologist can also administer effective procedures to address an acne problem. Chemical Peels can remove the blackheads and papules associated with mild acne. 11

12 ULTRASONIC GUIDE FOR USE FOR THE ULTRASONIC MODE Use the Lux Renew ultrasonic mode to relieve minor muscle aches and pains and for anti-aging. CONTRAINDICATIONS FOR THE ULTRASONIC MODE Do not use: Over the eyes. Over the carotid sinus nerves or arteries. Over laryngeal or pharyngeal muscles. Over mucus membranes. On tissue with open sores, lesions, bleeding, or infected areas. On tissue and/or bone with active infection. If you have poor arterial blood circulation. If you have phlebitis or deep venous thromboses. WARNINGS FOR THE ULTRASONIC MODE Do not use: In a region with malignant tumors. If you have a demand type cardiac pacemaker or electronic implant. In a bleeding or infected area. PRECAUTIONS FOR THE ULTRASONIC MODE Avoid bony prominences, e.g., bony part of the elbow. When using the ultrasonic mode, keep the handpiece moving while maintaining contact with the skin. Do not use over metallic implants. No additional risks are known. RISKS FOR THE ULTRASONIC MODE BENEFITS FOR THE ULTRASONIC MODE The benefit of treatment with ultrasound is anti-aging and the relief of minor muscle aches and pains. 12

13 PREPARATION FOR USE FOR THE ULTRASONIC MODE Connect the hand piece to the power adaptor, then connect the power adaptor to a power outlet. Press the On/Off button. There will be a beep and the LED display will show functions and time of use (default time of 15 minutes will display). INSTRUCTIONS, DIRECTIONS FOR USE, & OPERATING INSTRUCTIONS FOR THE ULTRASONIC MODE The treatment head must be pressed flat against the skin. NO YES For your Lux Renew device to operate properly, a conductive solution is needed when using the ultrasonic mode. Therefore, it is important to first apply water or a water-based gel to the skin areas to be treated. Apply vibration treatment for four minutes at each treatment site. You may use it longer if you wish. (4 minutes is a minimum guideline.) With your Lux Renew switched on, press MODE repeatedly to select Sonic in the display. When Sonic is flashing press SHIFT repeatedly to select one of the five intensity levels. Adjust the time of your treatment for 5 to 19 minutes by pressing MODE repeatedly until Time is selected (it will flash). Press SHIFT repeatedly to adjust the Time to the desired treatment time. Press CFM to start your session. Lux Renew will switch off automatically after the selected treatment time is completed. You may immediately switch it on again if you wish to continue your session in a different treatment area. 13

14 HANDLING THE DEVICE Along the jawline from chin to base of ear Along the jawline from chin to front of ear From corner of mouth to top of ear From corner of mouth to nose From nose to outer eye From nose to temple Use on the browbone and forehead in upward movements. 14

15 IMPORTANT INFORMATION INDICATIONS FOR USE Use the Lux Renew: In the LED mode: Red LED to treat periorbital and facial wrinkles. Red and blue LED mode to treat mild to moderate acne on the face. In the ultrasonic mode for anti-aging and to relieve minor muscle aches and pains. GLOSSARY Acne: A skin condition that occurs when your sebaceous glands/hair follicles become plugged with oil and dead skin cells. Acne most commonly appears on your face, neck, chest, back and shoulders. LED: an abbreviation for Light Emitting Diode, which is simply a very small light bulb. Lesion: Mark on skin produced by acne. The mildest lesions are comedones. Other lesions are: Comedones (whiteheads and blackheads) Created when the openings of hair follicles become clogged and blocked with oil secretions, dead skin cells and sometimes bacteria. When comedones (koe-muh-doe-neez) are open at the skin surface, they re called blackheads because of the dark appearance of the plugs in the hair follicles. When comedones are closed, they re called whiteheads slightly raised, skin-colored bumps. Papules inflamed lesions that usually appear as small, pink bumps on the skin and can be tender to the touch. Pustules (pimples) white or yellow pus-filled lesions that may be red at the base. Nodules large, painful, solid lesions lodged deep within the skin. Cysts deep, painful, pus-filled lesions that can cause scarring. Mild acne: Fewer than 20 whiteheads or blackheads, fewer than 15 inflamed bumps, or fewer than 30 total lesions. Moderate acne: 20 to 100 whiteheads or blackheads, 15 to 50 inflamed bumps, or 30 to 125 total lesions. Severe acne: More than 100 whiteheads or blackheads, or more than 50 inflamed bumps, or more than 125 lesions, or more than 5 cysts. Periorbital wrinkles: fine lines and wrinkles at the side of the eye, also known as crow s feet. AFTER USE INFORMATION Care of your Lux Renew Do not immerse in water. After use, turn off the power and remove the cable to avoid overheating. After each use, wipe the device clean with a soft cloth. Do not use water, chemical cleanser or dish detergent. TROUBLESHOOTING Problem Possible Cause Action Required LEDs do not turn on Buttons do not work Gives off burning smell or smoke. No power Button is bad Damaged or wrong power supply Check that power adaptor is plugged in to wall outlet. Check that power adaptor and cord are in good condition. Check that DC plug on power adaptor is inserted into handpiece correctly. Check that wall outlet has power. Contact Truth in Aging at customerservice@truthinaging.com Turn off unit immediately, unplug from the wall. Do not try to use the unit again. Contact Truth in Aging at customerservice@truthinaging.com 15

16 HOME & MOBILE ENVIRONMENT The Lux Renew may be used at home. You may also take it with you on trips. Review the Warnings and Precautions sections in this manual to ensure that you are not operating the device in an environment where it is not suited. Examples of such unsuitable environments would be on lakes or on rivers. EMC Compliance and Warning Statement IEC : 2006 EN : 2007 This equipment has been tested and found to comply with the limits of the standard for medical devices, IEC The unit also complies with the requirements of EN , providing the presumption of compliance to the European Union s Medical Device Directive 93/42/EEC and as amended by 2007 / 47 / EC. The limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy, and, if not installed and used in accordance with the manufacturer s instructions may cause harmful interference to other devices in the vicinity. Portable and mobile RF communications equipment can affect medical electrical equipment. There is no guarantee that interference will not occur in a particular installation. If this equipment causes interference with other devices, which may be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures: Reorient or relocate the device receiving the interference. Increase the separation between the equipment. Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. Consult the manufacturer or field service technician for help. The Lux Renew is designed for home use. TRAVEL WITH DEVICE When traveling with the Lux Renew, pack the device and power adaptor securely to prevent damage. The Lux Renew power adaptor accommodates V AC, 50/60 Hz, which is available in most countries. The Lux Renew comes with a standard non-polarized two-prong plug; a plug adaptor may be required for certain countries. WARRANTY INFORMATION One-Year Repair Guarantee In the event that your Lux Renew develops a fault within 12 months of purchase, please return it to: Truth In Aging 307 Seventh Avenue, Suite 2302 New York, NY 10001, USA customerservice@truthinaging.com What is not covered? Breakdown or damage due to: not following the operating instructions. incorrect or unauthorized repair. accidental damage during your own transportation. breakage. fire, earthquake, weather such as flood, lightning, high wind. Please visit for more information. IFU PL 0014 revh 16