ClearSkin Trio LUSTRE Blue Light Technology System Instruction Manual

Instructions for Use

Trio LUSTRE Blue Light Technology System

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.

LUSTRE ClearSkin Device
1 Pod with Solo, 3 Pods with Trio| Charger Cable
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|
LUSTRESTRIPS
30 strips with Solo, 90 Strips with Trio| Instruction Manual
|

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.
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| 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. until it feels secure.
| Step 4 — Press the ON/OFF button for 1 second to begin treatment.
The device should only be switched 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 LUSTRE ClearSkin at any time.
If this happens do not use.
Under normal use the LUSTRE 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. 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.
recycling point to be disposed of correctly.
In order to recycle this device you can return it to Lustre Skin Ltd.

Contact info

Lustre Skin Ltd
Alba Innovation Centre Alba Campus Livingston Scotland UK
EH54 7GA
T +(44)1506 592239
E info@lustreclearskin.com
W www.lustreclearskin.com
Lustre Skin Ltd is an ISO 13485:2016

Advena Ltd. Tower Business Centre, 2nd Flr.,
Tower Street, Swatar, BKR 4013 Malta

EU Economic Operator MDR/IVDR Article 13 Advena Services Ltd
Tower Business Centre, Tower S treet Swatar BKR 4013 Malta

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.
the original retail purchaser with original proof of purchase and only when purchased from an authorised retailer or reseller.
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 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
Life of the Device: the LUSTRE ClearSkin device is 2 years.

General Safety/EMC and Electrical Information for the LUSTRE ClearSkin

Device

1. General Safety
   1. LUSTRE ClearSkin is an electrical device, which under certain circumstances could present an electrical shock hazard to the user
   1.2 EN 60601-1:2006
   1.2.1 Protection against electrical shock – Class II
   1.2.2 Degree of protection against electrical shock – Type BF Applied Part
   1.2.3 Protection against dripping water when tilted up to 15° – IP22
   1.3 EMI/EMC
   1.3.1 Compliance with standard EN 60601-1-2:2015
   1.4 LED lighting (Blue Light)
   1.4.1 Compliance with standard EN62471:2008 – Photobiological safety of lamps and lamps system

For more info regarding EMC consult www.lustreclearskin.com

Symbol Glossary

| Refer to operating Instructions
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| Class II equipment – provides double Isolation to protect against electric shock
IP22| Degree of protection – IP22 Protection against penetration by solid objects with diameters larger than 12.5 mm. Protection against dripping water when tilted up to 15°.
| Type BF Applied Part
| Batch/Lot/ID Number This is the unique identifying number for each batch
| Catalogue number
| Manufacturer
| Store in a clean dry area up to 24°c – LUSTRESTRIPS
| Expiry date of the LUSTRESTRIPS
| WEEE Compliance
| Medical Device
| UK Conformity Assessed
| European Conformity
| Keep Dry
| Do not reuse – single use

©Lustre Skin Ltd 2023.
All rights reserved, LUSTRE, LUSTRE ClearSkin, and LUSTRESTRIPS are trademarks of Lustre Skin Ltd.
01/23 Version 600052.4
www.lustreclearskin.com

References

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

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