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Fulford House Newbold Terrace, 
LEAMINGTON SPA. 
CV32 4EA. 
United Kingdom
According to MDD 93/42/EEC, the décoLITE LED mask is classified as a cosmetic 
device within the European union. However, for purposes of safety we have conducted 
additional testing so that you can be ensured of the safety and efficacy of the décoLITE 
system.
The décoLITE system has been tested to or complies with the following standards;
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
IEC 60601-1-6 2010 AMD12013 Medical Electrical Equipment – Part 1 General 
Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability.
IEC/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 62471:2008 Photobiological Safety of Lamps and Lamp Systems
EN 62366-1:2015 Application of usability engineering to medical devices.
EN ISO 10993-1:2010-04 Biological evaluation of medical devices Part 1: Evaluation and 
testing 
EN ISO 15223-1:2017 Medical Devices – Symbols to be used with medical device labels, 
labelling and information to be supplied – Part 1: General requirements
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
EN 55014-1.2006+A1: 2009+A2 2011 Electro Magnetic Compatibility – requirements for 
household appliances, electric tools and similar apparatus – Part 1 emissions. 
EN 55014-2:2015 Electromagnetic compatibility- requirements for household appliances 
electric tools ad similar apparatus – part 2: immunity – product family standard.

Summary of Contents for Natural facelift decoLITE

Page 1: ...USER GUIDE ...

Page 2: ...E LED system or this User Guide décoLITE and the Natural facelift Company are trademarks of iSMART Developments Ltd Registered office Fulford House Newbold Terrace LEAMINGTON SPA CV32 4EA United Kingdom hello natural facelift com www natural facelift com The information in this document is proprietary to iSMART Development Ltd and supplied on the understanding that it shall be kept confidential to...

Page 3: ...r smoother and with a visible improvement in skin tone and texture lines and age spots 1 1 Intended use The décoLITE LED system emits light in the red and near infra red NIR region of the light spectrum and can be used to help reduce the signs of aging It is also indicated for the alleviation of pain increased blood flow and temporary relaxation of muscle can provide pain relief 2 0 Device Descrip...

Page 4: ...se décoLITE LED system to treat any other conditions apart from those listed in the indications for use The décoLITE LED system has not been tested for any other conditions than those listed and the risk is unknown DO NOT use décoLITE LED system if you are pregnant planning on becoming pregnant or breastfeeding The décoLITE LED system has NOT been tested on pregnant or breast feeding women and the...

Page 5: ...ld present an electrical shock hazard to the user Please read the accompanying user manual thoroughly and follow directions stated in the manual to assure maximum safety during operation Precautions The décoLITE strap contains a mixture of Polyester nylon and lycra If you are allergic to any of these materials you may not be able to use the straps provided The décoLITE system CANNOT be used in cha...

Page 6: ...nd sunscreen 5 Clean the mask using a water based wipe or a damp clean cloth Ensure that the device is NOT being charged when cleaning 6 Repeat 3 5 times a week for four weeks 7 0 Care and Maintenance Store décoLITE LED device at room temperature in dry conditions Use the carry bag provided Avoid storing the décoLITE LED system in dusty conditions in direct sunlight or in damp and humid conditions...

Page 7: ...rds for non laser light source medical equipment for home use EN 60601 1 11 2015 EN 60601 2 57 2011 and EN 60601 1 2 2015 and IEC 62471 2006 Photobiological Safety of Lamps and Lamp Systems EN 55014 1 2006 A1 2009 A2 2011 Electro Magnetic Compatibility requirements for household appliances electric tools and similar apparatus Part 1 emissions EN 55014 2 2015 Electromagnetic compatibility requireme...

Page 8: ...ght to replace a defective product with the most compatible product currently available 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 iSMART Developments Ltd or its authorised distributors shall not be responsible for any incidental special or ...

Page 9: ...ssential 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 62471 ...

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