SHANI DARDEN LED Light Therapy Mask User Manual

SHANI DARDEN LED Light Therapy Mask User Manual

INTRODUCTION

Thank you for choosing the Shani Darden LED Light Therapy Mask TM

The Shani Darden LED Light Therapy Mask TM brings the user the convenience of being able to deliver photo therapy treatments for the signs of skin ageing of the face and neck and mild to moderate acne vulgaris of the face in a single, convenient home use light emitting diode mask

To find out if the Shani Darden LED Light Therapy Mask TM is right for you, see Section 2 “Who Should Use The Shani Darden LED Light Therapy Mask TM”.

Users of this device can obtain benefit from using it only if they read and comprehend all information in the user manual. You must follow all the instructions in the user manual.

Before using the Shani Darden LED Light Therapy Mask TM you must carry out a sensitization test and wait 6 hours (see Section 6.3).
Please feel free to contact us at help@shanidarden.com if you have any comments about the product or this user guide

 WHO SHOULD USE THE SHANI DARDEN LED LIGHT THERAPY MASK TM?

The Shani Darden LED Light Therapy MaskTM uses 3 wavelengths of light to treat full face wrinkles and photoaging of the neck and mild to moderate acne vulgaris of the face.
Use this section to determine if the Shani Darden LED Light Therapy Mask TM is right for you.
Adults who are concerned about or show the visible signs of aging such as wrinkles and pigmentation of the face and neck.

Acne sufferers (≥14 years of age) who want to treat their mild to moderate acne outbreaks.

For users with acne vulgaris
The typical appearance of acne is a mixture of the following: a greasy skin, red pimples or spots, yellow pus-filled spots and scars.

Use the chart opposite to determine whether Shani Darden LED Light Therapy Mask TM Acne Mode is suitable for you.

Acne type

| Description|

Suitable for Acne Mode on the Shani Darden LED Light TherapyMaskTM

---|---|---
Clear Skin| No pimples or spots or yellow pus-filled spots. No whiteheads or blackheads.| NO
The Shani LEDLight Therapy Mask TM Acne Mode is NOT indicated for clear skin. The Shani Darden LED Light Therapy Mask should NOT be used to prevent pimples or spots forming.
Mild Acne| A few pimples or spots, a few pus-filled spots, some whiteheads or blackheads.| YES
Mild acne is suitable for treat- ment with the Shani Darden LED Light Therapy MaskTM Acne Mode.
Moderate acne| Some pimples or spots, some pus-filled spots, only a few small nodules Many whiteheads or blackheads.| YES
Moderate acne is suitable for treatment with the Shani Darden LED Light Therapy MaskTM Acne Mode.
Severe Acne| Many pimples or spots, many pus-filled spots. Some nodules. Many whiteheads or blackheads.| NO
The Shani Darden LED Light Therapy MaskTM Acne Mode is NOT indicated for severe acne. Please consult your doctor for a more appropriate treatment.
Whiteheads or Blackheads – Comedonal Acne| Many whiteheads or blackheads. No pimples or spots. No pus-filled spots.| NO
The Shani Darden LED Light Therapy MaskTM Acne Mode is NOT indicated for whiteheads orblackheads. Please consult your doctor for a more appropriate treatment.

If you have purchased the Shani Darden LED Light Therapy MaskTM and find that it is NOT suitable for you, please contact your point of purchase to return the device within the statutory return period.

DEVICE DESCRIPTION

The Shani Darden LED Light Therapy MaskTM consists of:

1. Face Mask
2. Neck Attachment
3. Controller
4. Power Supply and Country Specific Adaptors
5. Adjustable Head Strap
6. Adjustable Neck Strap
7. Dust Bag x3
8. User Manual

The Shani Darden LED Light Therapy MaskTM is a home use Professional grade wearable LED  photo therapy device.

The device consists of a Face Mask (1) and Neck Attachment (2) that contains light emitting diodes. The Face Mask and Neck Attachment are worn on the face and neck and are held in place by adjustable velcro straps (5 & 6).

The Face Mask has 3 treatment modes and emits light in the Blue, Red and Near- infrared region of the light spectrum.

MODE 1: emits light in the Red and Near-infrared region of the light spectrum and treats the visible signs of ageing such as facial wrinkles.
MODE 2: emits light in the Blue and Red region of the light spectrum and treats mild to moderate acne vulgaris of the face.
MODE 3: emits light in the Red and Near-infrared region of the light spectrum and treats the visible signs of photoaging such as pigmentation and age spots.

The Neck Attachment only treats photo aging of the neck and ONLY emits light in the Red and  Near-infrared region of the light spectrum. The neck attachment is oerational across all 3 treatment modes. The neck attachment does not contain Blue LEDs and does not treat acne vulgaris.

The Shani Darden LED Light Therapy MaskT M is controlled by a plug in controller (3). The controller contains 3 buttons and a graphical interface/display. The 3 buttons allow the user to

1. Wake up the device from standby/sleep mode
2. Select between treatment modes (wrinkle treatment mode, acne treatment mode and photo aging mode)
3. Start or pause the treatment

The graphical interface displays the treatment mode selected, a countdown timer to indicate the remaining time left for the treatment and the status of the treatment.

The Shani Darden LED Light Therapy MaskTM and Neck Attachment are connected to the controller by USB A connections (3) (the device has no WIFI connectivity and will NOT connect to any other device).

The power adaptor (4) is used to power the device. The power adaptor is connected to the controller by a co axial jack connector. The plug is connected to a suitable mains output.

The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent. The device contains no serviceable parts.

INTENDED USE

The Shani Darden LED Light Therapy Mask TM is an over-the-counter device intended to emit energy in the Red and Blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulga is of the face.

The Shani Darden LED Light Therapy Mask TM is an over-the-counter device intended to emit energy in the Red and Near-infrared spectrum and is intended for the use in the treatment of full-face wrinkles and the signs of photoaging such as pigmentation and age spots.

The Shani Darden LED Light Therapy Mask TM is intended to be used in the home environment by adults who show the visible signs of aging of the face and neck and users 14 years or older who want to treat their mild to moderate acne outbreaks

WHEN SHOULD SHANI DARDEN LED LIGHT THERAPY MASK TM NOT BE USED?

CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS CONTRAINDICATIONS

• DO NOT share the Shani Darden LED Light Therapy Mask TM with any other person. The Shani Darden LED Light Therapy Mask TM is for single person use only
• DO NOT use the Shani Darden LED Light Therapy Mask TM to treat any other conditions apart from those listed in the indications for use. The Shani Darden LED Light Therapy Mask TM has not been tested for any other conditions than those listed, and the risk is unknown.
• DO NOT use the Shani Darden LED Light Therapy Mask TM if you are pregnant, planning on becoming pregnant or breastfeeding. The Shani Darden LED Light Therapy Mask TM has NOT been tested on pregnant or breast-feeding women and therefore the risk to the fetus,  neonate or pregnant women is unknown
• DO NOT use the Shani Darden LED Light Therapy Mask TM if you are a child under 14 years of age. The safety of the device for children younger than 14 years of age has NOT been tested and the risk is unknown.
• DO NOT use the Shani Darden LED Light Therapy Mask TM if you suffer from light induced headaches.
• DO NOT use the Shani Darden LED Light Therapy Mask TM if you suffer from any genetic conditions of the eyes. The Shani Darden LED Light Therapy MaskTM has NOT been tested on subjects who suffer with genetic conditions of the eyes and therefore the risks are unknown. If you are unsure about any related eye condition and using the Shani Darden LED Light Therapy MaskTM contact your ophthalmologist or eye doctor.
• DO NOT use the Shani Darden LED Light Therapy MaskTM if you suffer from any photosensitive disorder (sensitization to light) of the eye. The Shani Darden LED Light Therapy MaskTM has NOT been tested on subjects who suffer with photosensitive disorders of the eye and therefore the risks are unknown. If you are unsure about any related eye condition and using the Shani Darden LED Light Therapy MaskTM contact your ophthalmologist or eye  doctor.
• DO NOT use the Shani Darden LED Light Therapy MaskTM if you suffer from lupus erythematosus, photosensitive eczema or albinism. If you use the Shani Darden LED Light Therapy MaskTM to treat lupus erythematosus, photosensitive eczema or albinism you may cause a severe skin reaction.
• DO NOT use Shani Darden LED Light Therapy MaskTM if you suffer from any photosensitive disorder (sensitization to light) of the skin. If you use the Shani Darden LED Light Therapy MaskTM and you suffer from a photosensitive disorder you may cause a severe reaction.
• DO NOT use the Shani Darden LED Light Therapy MaskTM if you are taking any medication that can cause photosensitivity. If you use the Shani Darden LED Light Therapy MaskTM and you are taking any medication that can cause photosensitivity you may cause a severe skin reaction.

For a full list of drugs that can cause photosensitivity, please visit ww.shanidarden.com/ledmask.

Photosensitivity is a common side effect of various medications. These can include certain antibiotics, chemotherapy drugs, and diuretics. If you are unsure about any medication, you may be taking consult your healthcare provider.

Other substances not listed above can also cause photosensitivity.

Common examples of these substances are: St John’s Wort, coal tar, deodorants, antibacterial soaps, artificial sweeteners, naphthalene (mothballs), petroleum products, brightening agents found in laundry detergent, and cadmium sulphide (a chemical injected into the skin during tattooing).

Warnings
Before using the Shani Darden LED Light Therapy MaskTM you must carry out a sensitization test (see Section 6.3).

• DO NOT use the Shani Darden LED Light Therapy Mask TM in any way that is not exactly as specified in these instructions for use. Use of the Shani Darden LED Light Therapy Mask TM other than exactly as specified in these instructions for use has not been tested and the risk is unknown.
  • DO NOT use the Shani Darden LED Light Therapy Mask TM in an environment that is NOT specified by the manufacturer. Use of the Shani Darden LED Light Therapy Mask TM in an environment NOT specified by the manufacturer may cause damage to the device or  harm to the user.

• TURN OFF and REMOVE the Shani Darden LED Light Therapy Mask TM immediately if it feels hot or your skin feels uncomfortably warm. STOP using the Shani Darden LED Light Therapy Mask TM during a treatment if you experience headaches, changes in vision or pain in your eyes.

• DO NOT use the Shani Darden LED Light Therapy Mask TM without first removing creams, lotions or make-up BEFORE treatment. Some ingredients in these products may cause light sensitization or may reduce the effect of the treatment. If you use the Shani Darden LED Light Therapy Mask TM without removing these products, you may cause a skin reaction, or may reduce the effect of the treatment.

• NEVER use the Shani Darden LED Light Therapy Mask TM near water or where water can be spilt onto the equipment. DO NOT use the Shani Darden LED Light Therapy MaskTM if you think it has come into contact with water. Keep the Shani Darden LED Light Therapy Mask TM away from HOT surfaces or direct sunlight. The Shani Darden LED Light Therapy Mask TM contains cables that could have the potential to cause strangulation. Keep out of the reach of infants.

• DO NOT attempt to modify the Shani Darden LED Light Therapy Mask TM in any way. Modifying the Shani Darden LED Light Therapy Mask TM will void your warranty. Modifying the Shani Darden LED Light Therapy Mask TM could cause an electric shock when the system is used again. The system contains no serviceable parts.

• DO NOT use the Shani Darden LED Light Therapy Mask TM if the mask, controller, plug adaptor or cord are damaged in any way.

General Safety

The Shani Darden LED Light Therapy MaskTM is an electrical device, which under certain circumstances could present an electrical shock hazard to the user. Please read this user manual thoroughly and follow all stated directions to assure maximum safety during operation. Only use the power supply that is supplied with the Shani Darden LED Light Therapy Mask TM (Product code: RHD20W120100).

Precautions

• The Shani Darden LED Light Therapy MaskTM straps contain a mixture of polyester, nylon and lycra. If you are allergic to any of these materials, you may not be able to use the head  strap provided. Contact help@shanidarden.com for other suggested options.Before each use, with the device switched off, clean the Shani Darden LED Light Therapy Mask TM. All surfaces of the Mask may be cleaned by following the cleaning instructions in Section 8.1. Before cleaning ensure that the Shani Darden LED Light Therapy Mask TM and controller are unplugged from the mains outlet.
• DO NOT use any other cleansing products other than those stated in the cleaning instructions. Use of other cleansing products may damage the Shani Darden LED Light Therapy Mask TM (see Section 8). Store the Shani Darden LED Light Therapy Mask TM at room temperature in dry conditions, away from direct sunlight

RISKS AND BENEFITS

POTENTIAL RISKS

• Immediately after treatment skin may appear red. Skin should return to normal within 1-2 hours.
• Some users have reported pigmentation, skin flaking or peeling, associated pruritis and dryness. This is transient and clears within a few days.
• Temporary headaches immediately following the light treatment. Headaches can be treated with an appropriate over the counter analgesic and rehydration.

This list, although not exhaustive, lists the most commonly reported side effects. If you
experience a side effect that is greater than that described above or a serious side effectnot listed, then you should seek advice from a healthcare provider and report such an incident firstly to the manufacturer and then national authority.

POTENTIAL BENEFITS

Acne: People who have undergone a course of 4 weekly treatments for 6 weeks using the Shani Darden LED Light Therapy Mask TM report a reduction of mild to moderate  acne vulgaris.

Wrinkles: People who have undergone a course of 5 weekly treatments for 6 weeks using
the Shani Darden LED Light Therapy MaskTM treatments report a reduction in fine lines and facial wrinkles.

FIRST TIME SETUP

• Unpack the Shani Darden LED Light Therapy MaskTM and check off the parts described in Section 3. Visually inspect the parts and connections. Return the device to your point of purchase if you think the device or connecting parts or components are damaged or have been previously used.
• DO NOT use the Shani Darden LED Light Therapy MaskTM if you notice the device or connecting parts or components are damaged.

POWERING THE SHANI DARDEN LED LIGHT THERAPY MASKTM

• Connect the Co axial Jack connector to the Co axial port on the Controller.
• Select the correct country specific plug connector and slide it into the power adaptor until you hear an audible click.
• Plug the Power adaptor into a suitable mains outlet. A blue LED will illuminate at the base of the controller to indicate the controller is receiving power. The device is now in standby/sleep mode.

CONNECTING THE SHANI DARDEN LED LIGHT THERAPY MASKTM AND NECK ATTACHMENT

TO THE CONTROLLER

The Shani Darden LED Light Therapy Mask TM and Neck Attachment are controlled and receive power via the USB A port located at the base of the controller. The user has 3 options for use.

USING THE MASK AND NECK ATTACHMENT TOGETHER

Connect the Male USB A connector of the Neck Attachment to the USB port of the controller. Connect the USB A connector of the Mask to the female USB A port of the Neck Attachment.

USING THE MASK ONLY
Connect the Male USB A connector of the Mask to the USB port of the controller.

USING THE NECK ATTACHMENT ONLY
Connect the Male USB A connector of the Neck Attachment to the USB port of the controller.

SENSITIZATION TEST

Before carrying out your first treatment you must carry out a sensitization test. Follow the step-by-step guide below.

1. Connect the Shani Darden LED Light Therapy MaskTM as per Section 6.

2.  Cleanse your inner arm to remove any skincare.

3. Place the Shani Darden LED Light Therapy MaskTM over your inner arm.

4.  First, press the standby button to wake up the device and select the Acne treatment
   mode (see Section 7.3). Allow the Shani Darden LED Light Therapy MaskTM to run for its full 10-minute treatment program.

5. Next, press the standby button to wake up the device and select the Wrinkle treatment mode (see Section 7.3). Allow the Shani Darden LED Light Therapy MaskTM to run for its full 10-minute treatment program.

6.  At any time if your skin feels HOT or uncomfortable STOP using the device immediately.

7.  After the treatment wait at least 6 hours. If your skin on your inner arm is red or itchy
   then the Shani Darden LED Light Therapy MaskTM is unsuitable for you. Return the device to the retailer within (30) days of purchase.

 USING THE SHANI DARDEN LED LIGHT THERAPY MASKTM

Regarding electromagnetic compatibility (EMC) and electromagnetic fields (EMF), in and around the home environment the Shani Darden LED Light Therapy MaskTM should be kept away from radio frequency (RF) equipment to avoid interference.

TREATMENT RECOMMENDATIONS

For the treatment of acne vulgaris the best results are seen after treating for 4 days a week for 6 weeks.

For the treatment of full face wrinkles the best results are seen after treating for 5 days a week for 6 weeks.

Maintenance treatment should be carried out as required, according to lifestyle and skin condition.

DO NOT over treat using the Shani Darden LED Light Therapy MaskTM. There is no additional benefit of exceeding the treatment time or treatment frequency.

WEARING THE SHANI DARDEN LED LIGHT THERAPY MASKTM

• The Shani Darden LED Light Therapy MaskTM comes with a velcro strap that is adjustable to allow you to comfortably wear the mask.
• To fit the Mask, thread the strap through the inlet holes on either side of the mask.
• Loop the strap around your head and secure firmly.
• Adjust if necessary.

UNDERSTANDING THE SHANI DARDEN LED LIGHT THERAPY MASKTM

CONTROLLER

The Controller contains 3 buttons and a graphical interface/display.The 3 buttons allow the user to:

1. Standby button that wakes up the device from standby/sleep mode.
2. Select between treatment modes (wrinkle treatment, acne or photoaging treatment mode).
3. Start/Pause the treatment
   

The graphical interface displays the treatment mode selected a countdown timer to indicate the remaining time left for the treatment and the status of the treatment.

Selecting a Treatment

First decide what area or combination of areas you wish to treat and connect the device appropriately (see Section 6.2).

Please NOTE the Neck Attachment does not treat acne vulgaris of the neck.

In treatment Mode 2 (acne) with the Neck Attachment connected the device ONLY emits Red and Near-Infrared light.

1.  With the device plugged into a mains outlet, press the Standby button (1) and hold until the display screen illuminates and the screen displays Mode 1 – Wrinkles

2. Press the Mode button (2) to toggle between the treatment modes.

3. Wrinkles

4. Acne

5. Photoaging
   The treatment mode will be displayed on the screen. After selecting the treatment mode press the Start/Pause button (3).The LEDs will illuminate

6. The Pause button will disappear and the treatment timer will count down in 1 minute increments.

7. You can turn OFF the Shani Darden LED Light Therapy MaskTM at any time by pressing the Power Button (1).

8. You can pause the treatment at anytime by pressing the Start/Pause button.

9. At the end of the treatment there is an audible beep and the Shani Darden LED Light Therapy MaskTM automatically switches OFF the LEDs.

10. The Shani Darden LED Light Therapy MaskTM will automatically turn off after 10 minutes.

CARRYING OUT A TREATMENT

1. Cleanse and exfoliate skin to remove any traces of skincare.
2. Connect the Controller to the mains output (Section 6.1).
3. Connect the Mask and/or Neck Attachment to the Controller (Section 6.2).
4. Secure the Mask and/or Neck Attachment with the velcro straps provided.
5. Follow Section 7.2.1 (Selecting a Treatment).
6. The device switches off after ten-minutes. You may stop the treatment at any time bypr essing the Pause button on the Controller.
7. Remove the device, apply your normal skincare.
8. Clean the device following instructions set out in Section 8.1. Ensure that the device is NOT connected to the Mains output during cleaning.
9. For best results follow the recommended treatment schedule in 8.1.

CARE AND MAINTENANCE

• Store the Shani Darden LED Light Therapy MaskTM at room temperature in dry conditions. Use the dust bag provided.
• Avoid storing the Shani Darden LED Light Therapy MaskTM in dusty conditions, in direct sunlight or in damp and humid conditions.
• The Shani Darden LED Light Therapy MaskTM contains no serviceable parts.
• Before each use, with the device switched off, clean the face mask following the cleaning instructions in Section 8.1.
• efore each use, visually inspect the Shani Darden LED Light Therapy MaskTM, controller and cables for damage. Do NOT use the device if you notice any signs of visible damage.
• If you follow the care and maintenance for your Shani Darden LED Light Therapy Mask™, the device has a minimum lifetime of 2 years.

CLEANING THE SHANI DARDEN LED LIGHT THERAPY MASKTM

DO NOT use any other cleansing products as these may damage the plastics. Before cleaning ensure that the Shani Darden LED Light Therapy MaskTM and controller are unplugged from the Mains outlet.

• Clean all surfaces of the mask with a water based wipe. Stubborn stains can be removed by wiping gently with 70% alcohol.

DISPOSAL

DO NOT dispose of any part of the Shani Darden LED Light Therapy MaskTM at adomestic waste facility. Please contact customer service at help@shanidarden.com or visit our FAQ page at www.shanidarden.com/ledmask for more information on proper disposal of this device.

TROUBLESHOOTING

controller.Ensure the power supply country specific plug adapter has been fully engaged into the main power supply unit with an audible  “click”. Ensure the power adaptor is plugged into a suitable mains output.
No light from the LEDs when you press the power button.| Connection issue between Controller and Mask. Device could be faulty.| Ensure the Mask and or Neck attachment are plugged into the controller. If you need further assistance  please contact help@shanidarden.com.
LEDs in the Mask do NOT illuminate but LEDs in the Neck  Attachment do illuminate.| Connection issue between Controller and the Mask/Neck Attachment. Device could be faulty.|  Ensure the USB connections betweenthe controller and Mask and Neck Attachment are secure. If you need further assistance please contact help@shanidarden.com.
LEDs in the Neck Attachment do NOT illuminate but LEDs in the MASK do illuminate.| Connection issue between Controller and the Mask/Neck Attachment
Device could be faulty.| Ensure the USB connections between the Controller and Mask and Neck Attachment are secure. If you need further assistance please contact help@shanidarden.com.
LEDs in the Neck Attachment do NOT illuminate but LEDs in the MASK do illuminate.| Connection issue between Controller and the Mask/Neck Attachment
Device could be faulty.| Ensure the USB connections between the Controller and Mask and Neck Attachment are secure. If you need further assistance please contact help@shanidarden.com.
Can’t toggle between treatment modes.| Device could be faulty.| Unplug the Controller from the mains ouput. Unplug the Mask from the Controller. Wait 1 minute and then re connect all connections. If the issue persists, please contact help@shanidarden.com.
Display does not illuminate but LEDs do illuminate.| Device is faulty.| Please contact help@shanidarden.com for further assistance.
LEDs do NOT turn OFF after 10 minutes.| Device is faulty.| Please contact help@shanidarden.com for further assistance.
LEDs flicker continuously during treatment.| Device is faulty.| Please contact help@shanidarden.com for further assistance.

If the actions suggested above fail to fix the problem, or the problem reoccurs, and your device is within the warranty period, please contact help@shanidarden.com for further assistance.

• DO NOT attempt to investigate any further.
• DO NOT attempt to modify the device in any way. The Shani Darden LED Light Therapy MaskTM has NO parts you can repair yourself

LABELING

• The labeling supplied with the device contains the following information
• Date of Manufacture
• Item Number, Batch Code and Serial Number
• Operating Environment
• Manufacturers Information
  Please refer to Section 12 (Explanation of Symbols).

RECYCLING

This symbol means that this product shall not be disposed of with normal household waste (2012/19/EU).
We advise you to take your product to an official collection point to have a professional dispose of the product correctly. Follow your country’s rules for the separate collection of electrical and electronic products. Correct disposal helps prevent damage to the environment and human health.

TECHNICAL SPECIFICATION

• Model Number (REF): TN2118
• Program Time: 10 minutes fixed
• Wavelengths: 415nm, 633nm and 830nm +/- 10nm
• Maximum Output Intensity: Blue/Red 44 mw/cm2, Red/NIR 29 mw/cm2
• Operating Temperature: 5°C to 30°C
• Operating Humidity: 15% to 90% without condensation
• Operating Atmospheric Pressure Range of 700 hPa to 1060 hPa
• Storage and Transport Temperature: -25°C to +5°C and +5°C to +35°C at a relative humidity up to 90% condensing, > 35°C to 70°C at a water vapor pressure up to 50 hPa
• Storage and Transport Humidity: 20% to 90% without condensation
• Electrical Input to Power Adaptor: 100v-240v. 50/60Hz. Rated at 0.7A.
• Electrical Output from Power Adaptor: 12V, 1A
• IP22

EXPLANATION OF SYMBOLS

There are several safety warning-labels on the Shani Darden LED Light Therapy MaskTM, Controller, user guide and packaging. Use this guide to interpret them

• This symbol on the device label indicates that caution is necessary. Failure to follow Warning or Cautions may lead to an undesirable outcome.

• This symbol on the device label means read the user manual before you start using the device.

• This symbol means that the Shani Darden LED Light Therapy MaskTM is specified as applied part type BF, indicating that it is used on the body and has some conductive contact

•   This symbol means that the device may be used multiple times by a single patient.

• This symbol means the Shani Darden LED Light Therapy MaskTM conforms to certain EC Regulations /Directives on health, safety, and environmental protection standards. CE stands for ‘Conformité Européenne’.

• This symbol means “Manufactured by” and provides the name and address of the legal manufacturer.

• This symbol indicates input for the power supply (wall outlet) and that the device may only be powered with the adapter that is supplied in the package. Usage of other adapters may not be safe and could lead to electrical shock. The adapter hasthe following electrical specification: Electrical Input to Power Adaptor: 100v-240v. 50/60Hz. Rated at 0.7A. Electrical Output from Power Adaptor: 12V, 1A.

• This symbol means keep dry.

• This symbol indicates the serial number of the device.

• This symbol refers to the catalogue number for the Shani Darden LED Light Therapy
  MaskTM.

• This symbol refers to the batch code of the Shani Darden LED Light Therapy MaskTM.

• This symbol refers to the unique device identifier; an internationally recognized way of marking and identifying medical devices within the healthcare supply chain.

• This symbol indicates the product is a medical device.

• This symbol means the product is made in China.

• This symbol means keep the device away from direct sunlight.
  This symbol means the upper and lower operating temperatures that the Shani

• Darden LED Light Therapy MaskTM can be safely used at.

• This symbol means the upper and lower operating humidity that the Shani Darden LED Light Therapy MaskTM can be safely used at.

•  This symbol means that the cardboard packaging that the Shani Darden LED Light Therapy Mask TM came in can be can be safely used at.

•   This symbol means that the cardboard packaging that the Shani Darden LED Light Therapy MaskTM came in can be recycled.

• This symbol means that the device is protected against solid objects over 12.5mm in diameter (such as fingers) and vertical water droplets when the device is tilted 150C.

• This symbol means that this product shall not be disposed of with normal household waste (2012/19/EU).

• Importer (EU only)

• • Distributed by

WARRANTY

STANDARD WARRANTY

Under normal use this product is guaranteed for 2 years after its original purchase date against manufacturing defects in materials or workmanship.

WARRANTY EXCEPTIONS

The lithium battery is guaranteed for 1 year after its original purchase date against manufacturing defects in materials or workman ship.

This warranty extends only to the original purchaser.

This warranty does not cover damage caused by the following:

• Accident, misuse, abuse or alteration
• Servicing by unauthorized persons
• Connection to incorrect power sources
• Use with unauthorized accessories

WHAT TO DO IF YOUR PRODUCT IS FAULTY

If the product should become faulty within the warranty period, contact your place of
purchase.

Shani Darden Skincare, Inc. or its authorized distributor reserves the right to replace a defective product with the most compatible product currently available.

Shani Darden Skincare, Inc. or its authorized distributors shall not be responsible for any
incidental, special or consequential damages resulting from the use of this product.All implied warranties, including but not limited to implied warranties of fitness and merchan tability are limited in duration to one year from date of original purchase.

This warranty gives you specific legal rights, and you may also have other rights that  vary from country to country. Some countries do not allow the exclusion or limitation of incidental or consequential damages, or limitations on how long an implied warranty lasts, so some of the above limitations and exclusions may not apply to you.

This warranty is given in lieu of all other warranties, written or oral, whether expressed by affirmation, promise, description, drawing, model or sample. Any and all warranties  otherthan this one, whether expressed or implied, including implied warranties of  merchantabilityand fitness for a particular purpose are hereby disclaimed.

The Shani Darden LED Light Therapy MaskTM is Manufactured for Shani Darden Skincare, Inc. in association with Harpar Grace International by iSMART Developments Ltd, 129 Green Lanes Sutton Coldfield West Midlands B73 5LT United Kingdom.

Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) (UK medical devices regulations)

Medical Devices Regulations 2002 (SI 2002 No. 618, as amended) (UK medical devices regulations)

EN 60601-1:2006/A12:2014. Medical electrical equipment. General requirements for basic safety and essential performance.

EN 60601-1-2:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests including FCC 47 CFR Part 15, Sub Part B This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

EC/EN60601-1-11:2015 Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment.

IEC/EN 60601-2-57:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for  therapeutic,diagnostic, monitoring and cosmetic/aesthetic use.

EN 62304:2006+A1:2015. Medical Device Software. Software life cycle processes. EN 62471:2008 Photobiological Safety of Lamps and Lamp Systems. EN 62366-1:2015 Application of usability engineering to medical devices. EN ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing

EN ISO 15223-1:2021 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements.

EN ISO 14971:2019 Medical devices – Application of risk management to medical devices.

ISO 20417-2021 Medical devices — Information to be supplied by the manufacturer. BS EN 55014-1:2020 Electromagnetic compatibility. Requirements for household appliances, electric tools and similar apparatus. Emission0

BS EN 55014-2:2015 Electromagnetic compatibility. Requirements for household appliances, electric tools and similar apparatus. Immunity. Product family standard.

BS EN 55014-2:2015 Electromagnetic compatibility. Requirements for household appliances, electric tools and similar apparatus. Immunity. Product family standard.

Users of this device can obtain benefit from using it only if they read and comprehend all information in the user manual. You must follow all the instructions in the user manual.

A copy of this user manual is available at www.shanidarden.com/ledmask

The Shani Darden LED Light Therapy Mask TM is Manufactured for Shani Darden Skincare, Inc. in association with Harpar Grace International by iSMART Developments Ltd, 129 Green Lanes Sutton Coldfield West Midlands B73 5LT United Kingdom.

If you have any questions relating to the Shani Darden LED Light Therapy MaskTM please do not hesitate to contact us.

Shani Darden Skincare, Inc. PO Box 598, Beverly Hills, CA 90213 • Customer Service Email: help@shanidarden.com

The information in this document is proprietary to iSMART Development Ltd, and supplied on the understanding that it shall be kept confidential to recipients and that it shall not be reproduced and/or used for commercial purposes without the written consent of Med-Di-Dia Limited Galway Technology Centre Mervue Business Park, Galway, Ireland

References

• Arden – AI, VR, AR, 3D, NLP, VC
• Darden Restaurants: A Leader in the Full-Service Restaurant Industry
• Shani Darden Skin Care | Clinical Facial Products
• Shani Darden Skin Care | Clinical Facial Products
• FAQ – Shani Darden Skin Care

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