Omnilux New-U, User Manual

Page 1: ...USER GUIDE Turn back time switch on the light New U UserGuide 81 034 indd 1 7 11 08 8 55 09 AM ...

Page 2: ...hemical manual or otherwise without the prior written consent of Photo Therapeutics Inc Contents Introduction 1 The Omnilux new U 2 Omnilux new U Lifetime 5 Indications for Use 5 Contraindications 6 Warnings 6 Precautions 7 Risks and Benefits 8 Before Using Omnilux new U 9 Using Omnilux new U 11 Care and Maintenance 13 Outside the United States 14 Storage 14 Disposal 14 Labeling 14 Troubleshooting...

Page 3: ...n of the skin diminishes and our skin becomes less flexible In addition our skin becomes drier and thinner and as the body s natural regeneration process slows down the skin slowly loses its ability to retain moisture and loses that teenage glow The harmful rays in sunlight further damage the skin s supportive structure and prevent the creation of new collagen This leads to the development of fine...

Page 4: ...s an array of Light Emitting Diodes LEDs a ventilation fan a three position switch and a connection socket Yellow indicator diodes 3 way switch Lens cover Front View CE Label Connection socket Ventilation slots Rear View Year Month PN EL1601 Manufactured by Photo Therapeutics Inc CA 92010 28V DC 0 57A PAGE 2 New U UserGuide 81 034 indd 4 7 11 08 8 55 14 AM ...

Page 5: ...FRARED light output or the OFF position Omnilux new U treatment unit Switch Positions Move the switch DOWN for RED light Move the Switch UP for INFRARED light Move the switch to the CENTER position for OFF Since infrared light is not visible to the eye the Omnilux new U has two yellow LEDs as shown above which light up when the device is emitting infrared light OFF RED INFRARED PAGE 3 New U UserGu...

Page 6: ...ch plugs into the socket on the rear of the Omnilux new U Plug Cord Omnilux Wall Power Supply with Cord The Omnilux new U has been tested to International standards to ensure that its outputs are safe for the eyes However we have supplied a set of patient goggles that we recommend you wear for your own comfort Power supply may vary depending on country PAGE 4 New U UserGuide 81 034 indd 6 7 11 08 ...

Page 7: ...effective treatments Indications for Use The Omnilux new U is a medical device intended to be used for the reduction of periorbital wrinkles Periorbital wrinkles are wrinkles around the eye often referred to as crowsfeet Crowsfeet tend to appear as the skin ages or becomes sun damaged Visible signs of aging can be the appearance of fine lines and wrinkles around the eye area Example of periorbital...

Page 8: ...se DO NOT use the Omnilux new U if you are pregnant The safety of the treatment for pregnant women has NOT been tested and the risk is unknown To reduce the risk of serious injury or fatal electrical shock NEVER use the Omnilux new U or the Wall Power Supply where they can fall or be pulled into water NEVER use the Omnilux new U or the Wall Power Supply when bathing or standing in water NEVER use ...

Page 9: ...how to clean your Omnilux new U To reduce the risk of damaging your Omnilux new U NEVER cover the air vents in the Omnilux new U They are provided for ventilation Be aware of objects items of clothing or material that may accidentally block the air vents ALWAYS keep the Omnilux new U its Wall Power Supply and cord away from heated surfaces High temperatures may damage the plastic cases or the inte...

Page 10: ... weeks after you have completed the recommended course of treatments The light stimulates natural processes that continue after the treatment has stopped You may experience erythema mild skin redness If it lasts longer than 24 hours you should stop using Omnilux new U and seek advice from a healthcare professional What to expect after a course of treatments Before top and after bottom the recommen...

Page 11: ...he eyes The red light output of the Omnilux new U is less than 1 6th of the safe limit The infrared light output of the Omnilux new U is less than 1 600th of the safe limit Before you use the Omnilux new U Some people are sensitive to light If you are one of these people the Omnilux new U may not be suitable for you To determine if you are sensitive to light we recommend that you carry out a test ...

Page 12: ...new U in contact with treatment area or at a maximum of 1cm 0 5 from your upper forearm and leave in position for 20 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 PAGE 10 If after 24 hours you have not experienced an adverse reaction to the r...

Page 13: ...hin 24 hours start treatment regime 20 minutes IR light 3 Week 1 first day Day 1 20 minutes IR light 4 Two days later Day 3 20 minutes RED light 5 Week 2 first day Day 8 20 minutes IR light 6 Two days later Day 10 20 minutes RED light 7 Week 3 first day Day 15 20 minutes IR light 8 Two days later Day 17 20 minutes RED light 9 Week 4 first day Day 22 20 minutes IR light 10 Two days later Day 24 20 ...

Page 14: ...nilux new U reaches the skin 1 ALWAYS switch the wall outlet socket off If you do not switch the outlet off there is a risk that you may touch a live pin when plugging the Wall Power Supply into the outlet 2 PLUG the wall power supply into the wall outlet socket 3 PLUG the wall power supply connector into the Omnilux new U 4 SWITCH the wall outlet socket on 5 FIT patient goggles 6 OPERATE the sele...

Page 15: ...reatment AVOID placing the Omnilux new U face down on a hard surface as this may scratch the lens cover AVOID placing the Omnilux new U unit in a dusty or dirty environment Dirt or dust may restrict the airflow through the Omnilux new U causing it to switch off before the end of the treatment time The exterior of the Omnilux new U unit may be cleaned by wiping it with a damp not wet cloth or an is...

Page 16: ...nd of its working life Labeling The label on the rear face of the Omnilux new U contains the following information Model Number Electrical Requirements Date of Manufacture Troubleshooting Photo Therapeutics Inc record and analyze all faults reported to them The majority of faults reported have a simple cause and can be readily put right by the user They are listed in the troubleshooting table on t...

Page 17: ...ulty switch Return to Photo Therapeutics Inc for servicing No red light output fan running Faulty switch Return to Photo Therapeutics Inc for servicing No Infrared light output fan running Faulty switch Return to Photo Therapeutics Inc for servicing Light will not switch off Faulty switch Return to Photo Therapeutics Inc for servicing Light cuts out during treatment fan not running Faulty fan Retu...

Page 18: ...nditions beyond our control Photo Therapeutics Inc 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 merchantability are limited in duration to one year from date of original purchase This warranty gives you specific legal rights and you may also h...

Page 19: ...eferences 1 Takezaki S Omi T Sato S Kawana S Light emitting diode phototherapy at 630 3 nm increases local levels of skin homing T cells in human subjects J Nippon Med Sch 2006 73 75 81 2 Takezaki I et al Ultrastructural Observations Of Human Skin Following Irradiation With Visible Red Light Emitting Diodes LEDs A Preliminary In Vivo Report Laser Therapy 14 4 153 160 3 Lee SY et al A prospective r...

Page 20: ... 0 1827 252 830 Support 44 0 161 925 5610 Facsimile 44 0 1827 287 391 Photo Therapeutics Inc 2720 Loker Ave West Suite C Carlsbad CA 92010 USA Tel 760 607 0488 Toll Free 800 743 8150 Fax 760 607 0288 Contact us at www phototherapeutics com ID 81 034 DES Tech 0998 v4 New U UserGuide 81 034 indd 20 7 11 08 8 55 39 AM ...