LUSTRE ClearSkin SOLO Blue Light Treatment Instruction Manual

LUSTRE ClearSkin SOLO Blue Light Treatment

Product Information

The LUSTRE ClearSkin Blue Light Technology is a device indicated for the treatment of mild to moderate acne. It can be used on the face, back, and shoulders. The device uses blue light to fight acne spots and blemishes naturally and safely, without any harsh chemicals. It promotes clearer, cleaner, and healthier-looking skin with regular use, and can also contribute to the prevention of future outbreaks. The LUSTRE ClearSkin system is safe, gentle, and easy to use, with no UV radiation or chemicals involved. It is suitable for use on various areas prone to acne such as the face, shoulders, and back.

Product Usage Instructions

• Before starting the treatment:

  • Ensure that your skin is clean and dry, and remove any makeup from the treatment area.
  • Perform a skin sensitivity test by applying a LUSTRESTRIP to a small area of your skin before the first treatment.

• Charging LUSTRE ClearSkin:
  The device should be charged before use. When the battery needs to be charged, the LED indicator will turn red.

• How to use LUSTRE ClearSkin:

  • Ensure that your skin is clean and dry, and all makeup is removed from the treatment area.
  • Attach a LUSTRESTRIP to the LUSTRE ClearSkin device by peeling off the blue tab and cover paper from the backing sheet.
  • Remove the cover paper and place LUSTRE ClearSkin over the treatment area, pressing it down gently.
  • Press the ON/OFF button for 1 second to start the treatment. The device should only be switched on after it has been affixed to the skin.
  • The treatment will last for 20 minutes, after which LUSTRE ClearSkin will turn off automatically and emit a short beep to signal the end of the treatment.
  • To remove the LUSTRE ClearSkin device from the treatment area, carefully and slowly pull the LUSTRESTRIP using the adhesive strip tab. Discard the used LUSTRESTRIP.

• Contraindications:

  • Do not use LUSTRE ClearSkin if you have a history of porphyria, solar urticaria, chronic actinic dermatitis, or photosensitivity.
  • Do not use LUSTRE ClearSkin over any suspicious or cancerous lesions.
  • Do not use LUSTRE ClearSkin if you are taking Amiodarone or any photosensitizing treatment.
  • Do not use LUSTRE ClearSkin over or near a recent steroid injection.
  • Do not use LUSTRE ClearSkin if you suspect that you have had an adverse/allergic reaction.

• Warnings:

  • The operator (user) should not place LUSTRE ClearSkin over the eyes or where the light will shine into the eyes during treatment. Avoid looking directly at the LED screen when it is switched on.
  • Always keep LUSTRE ClearSkin away from water and moisture. Never insert objects into its openings or disassemble the device.
  • Do not use LUSTRE ClearSkin if it appears damaged or if any of the power cables appear damaged.

Indication for use

LUSTRE ClearSkin Blue Light Technology is indicated for the treatment of mild to moderate acne. It can be used on the face, back and shoulders.

Benefits

• Fights acne spots and blemishes naturally and safely without any harsh chemicals.
• Promotes clearer, cleaner, healthier looking skin day  after day.
• Used daily, contributes to the prevention of future outbreaks.

LUSTRE can be used on areas prone to acne such as face, shoulders and back.

What’s in the box?

Blue Light Technology System. Safe, gentle & easy to use: No UV, no Chemicals & hands-free. Suitable for face, shoulders & back.

PRODUCT OVERVIEW

Before you start treatment

Testing Your Skin

• A small number of people have a skin type which is more sensitive to the normal level of adhesion of the LUSTRESTRIPS.
• The best way to check whether your skin is more sensitive is to carry out a short test before your first treatment.
• Attach a LUSTRESTRIP to a LUSTRE ClearSkin device and place on your inner forearm, just below the elbow. The LUSTRE ClearSkin treatment head should be switched on and left in place for at least 20 minutes before being removed carefully by lifting from one edge. If there is any discomfort, then we recommend applying a very small amount of moisturising cream to the skin before attaching LUSTRESTRIP next time and this will normally solve the problem. Because of the strength of the adhesive, with 40 mins sessions, temporary marks can occur. These marks are only temporary and will disappear progressively and naturally. Some skin types may display a temporary darkening which usually fades in 48 hours.

Charging  LUSTRE ClearSkin

Charging

• Connect the supplied charging cable to the LUSTRE ClearSkin device. Insert the charging cable into a suitable USB port delivering 5 volts DC at 1 amp maximum.
• If using a mains adaptor it is recommended that the device is charged using an IEC60601-1 compatible mains adaptor.
• The ON/OFF button will turn green when  LUSTRE is fully charged
  • LUSTRE will provide three 20 minute treatments when fully charged
  • Do not start the treatment if the ON/OFF button is red as this signifies the battery needs to be charged

How to use LUSTRE ClearSkin

• Step 1 — Ensure skin is clean and dry and all make up is removed before treatment.

• Step 2 — Attach a LUSTRESTRIP to the LUSTRE ClearSkin device. Peel the blue tab together with the cover paper from the backing sheet and apply to the device.

• Step 3 — Remove the cover paper and place LUSTRE ClearSkin over the treatment area, press down.

• Step 4 — Press the ON/OFF button for 1 second to begin treatment. The device should only be switched on AFTER it has been affixed to the treatment area of skin.

• Step 5 — LUSTRE will turn off automatically after 20 mins. A short beep will signal the end of the treatment.

• Step 6 — To remove The LUSTRE ClearSkin device from the treatment area carefully and very slowly pull the LUSTRESTRIP using the adhesive strip tab. Remove and discard the LUSTRESTRIP.

Cautions and contraindications
Read all of the instructions before using LUSTRE ClearSkin. Please consult your healthcare provider before using LUSTRE ClearSkin if you have been prescribed any medication for Acne.

• Pigment darkening caused by visible wavelengths, i.e. blue light, may be seen in darker skin types and is transient.
• Blue light therapy has not been tested with pregnant women. We recommend that you speak with your GP or midwife before considering using LUSTRE if you are pregnant.
• Not recommended for children under 13 years old. If you are unsure, please speak to a healthcare professional.

Contraindications

• Do Not use LUSTRE ClearSkin if you have a history of porphyria, solar urticaria, chronic actinic dermatitis, photosensitivity.
• Do Not use LUSTRE ClearSkin over any suspicious or cancerous lesions.
• Do Not use LUSTRE ClearSkin if you are taking Amiodarone.
• Do Not use LUSTRE ClearSkin
• if you are taking any photosensitising treatment.
• Do Not use LUSTRE ClearSkin over or near a recent steroid injection.
• Do Not use LUSTRE ClearSkin
• if you suspect that you have had an adverse/allergic reaction.

Warnings
The operator is considered the patient.

• Do Not place LUSTRE ClearSkin over the eyes, or where the light will shine into the eyes during treatment.
• Do Not look directly at the LED screen when it is switched on. Always keep LUSTRE ClearSkin away from water and moisture.
• Never insert objects into the openings of the LUSTRE ClearSkin.
• Never use LUSTRE ClearSkin if it appears damaged or if any of the power cables appear damaged Never disassemble LUSTRE ClearSkin.
• Do Not allow any fluid to enter LUSTRE ClearSkin at any time.
• If this happens do not use. Under normal use the LUSTRE ClearSkin will not exceed a temperature of 43°C.
• Keep the device out of reach of children.
• Contains a cable that may pose a risk of strangulation.
• The LUSTRESTRIPS should always be carefully removed after use to help avoid damage to the skin.

Cleaning

• LUSTRE ClearSkin is not waterproof. If the LUSTRE ClearSkin device requires cleaning at any time, use a soft dry cloth or a cleansing wipe.
• Do not allow any fluid to enter any part of LUSTRE ClearSkin device, this includes cleaning detergent. If this happens do not use.
• For hygiene reasons, do not share your LUSTRE ClearSkin device with anyone else.
• The cleaning of LUSTRE ClearSkin device shall be capable of being performed by the operator in the home healthcare environment.

Disposal

• Waste Electrical and Electronic Equipment (WEEE). Do not dispose of the device with normal domestic waste at the end of its life.
• Please take it to an official recycling point to be disposed of correctly.
• In order to recycle this device you can return it to Ambicare Health Ltd.

Contact info
Ambicare Health Limited Alba Innovation Centre Alba Campus Livingston Scotland UK EH54 7GA

• T +(44)1506 592239
• E info@ambicarehealth.com
• W www.lustreclearskin.com
• Ambicare is an ISO 13485:2016 certified company

Warranty

• LUSTRE ClearSkin treatment for acne is warranted to be free from defects in material and workmanship for a period of 12 months from its original purchase date under normal use. This warranty extends only to the original retail purchaser with original proof of purchase and only when purchased from an authorised retailer or reseller.
• This warranty only extends if the LUSTRE ClearSkin device is used in conjunction with authorised LUSTRESTRIPS.
• If the product should become defective within the warranty period, contact the retailer that you purchased the device from.
• This warranty does not cover products damaged by:
  • Accident, misuse, abuse or alteration.
  • Use with unauthorised accessories or use other than as instructed.
  •  Connecting to incorrect current and voltage.
• To register your product and be kept up-to-date with new and exciting developments from the LUSTRE team, please take a moment to sign up on our website www.lustreclearskin.com
• To complete your registration online you will need to enter your LUSTRE ClearSkin batch number.

Specifications

• Operating Wavelength: 415nm +/- 15nm
• Operating Temperature / Humidity: 10°C to 30°C / 20% to 85%
• Operating Irradiance: 5mw/cm2
• Storage and Transport Temperature / Humidity: 5°C to 60°C / less than 85%
• Mains Electrical Input: If using a mains adaptor, it is recommended that the device is charged using an IEC60601-1 or equivalent compatible mains adaptor delivering 5VDC/1A max per port.
• Life of the Device: The expected service life of the LUSTRE ClearSkin device is 2 years.

General Safety/EMC and Electrical Information for the LUSTRE ClearSkin

Device

General Safety

1. LUSTRE ClearSkin is an electrical device, which under certain circumstances could present an electrical shock hazard to the user
2. EN 60601-1:2006
3. Protection against electrical shock – Class II
4. Degree of protection against electrical shock – Type BF Applied Part
5. Protection against dripping water when tilted up to 15° – IP22
6. EMI/EMC
7. Compliance with standard EN 60601-1-2:2015
8. LED lighting (Blue Light)
9. Compliance with standard EN62471:2008 – Photobiological safety of lamps and lamps system
   For more info regarding EMC consult www.lustreclearskin.com

Symbol Glossary

References

• Clinically Proven LED technology | LUSTRE® ClearSkin
• Clinically Proven LED technology | LUSTRE® ClearSkin

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