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Radiancy FSD+, Руководство пользователя

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8.  Standards, Safety and Specifications

Design and technical specifications are subject to change without notice�  

International Standards

FSD Plus complies with the following international standards and directives: 

Electrical Safety

Medical Electrical Equipment – Part 1: General Requirements for 
Basic Safety and Essential Performance, 3rd Ed: IEC60601-1:2005/
EN60601-1:2006
Electromagnetic Compatibility 
IEC 60601-1-2:2007

EU Directive:

Low Voltage Directive 2006/95/EC 
Electromagnetic Compatibility Directive 2004/108/EC

The CE mark represents the compliance to the European Low Voltage Directive 
2006/95/EC and the Electromagnetic Compatibility Directive 2004/108/EC�

Содержание FSD+

Страница 1: ...User Manual Facial SkinCare Device...

Страница 2: ...n other countries The Quality Management System of Radiancy Ltd complies with the Quality Management Standard ISO 13485 2012 Manufacturer Radiancy Israel Ltd 5 Hanagar Street 45240 Hod Hasharon Israel...

Страница 3: ...duction to FSD Plus 4 Safety Instructions 5 Device Description 8 Know Before You Start 11 Operating Instructions 14 Maintenance 18 Troubleshooting 20 Standards Safety and Specifications 21 Service Inf...

Страница 4: ...totherapy at its core FSD Plus can be used either for stand alone treatments or as a part of a more comprehensive skin care program FSD Plus is based on Radiancy s patented LHE Technology LHE has been...

Страница 5: ...operate this device if it has a damaged cord or plug if it is not working properly if it has been damaged or dropped into water In any of these cases return the device to a service center for examina...

Страница 6: ...a 5 Always use protective eyewear 6 Never point the handpiece so it emits a light pulse into free space Make sure that during treatment the handpiece is pointed at the skin and in full contact with it...

Страница 7: ...s been on a steroid regimen i e asthma within the past 3 months 9 Has a history of herpes outbreaks in the area of treatment unless the user has consulted a physician and received prophylaxis treatmen...

Страница 8: ...8 3 Device Description FSD Plus is made up of three main components the main unit the handpiece and the power cord Main Unit Hand Piece Control Panel Pulse Counter On Off Switch...

Страница 9: ...dy and charging There is also a mute switch and energy level settings for low medium and high Energy Levels Mute Button Ready Indicator Light Charging Indicator Light Power On Light Hand Piece Accesso...

Страница 10: ...ased emissions or decreased immunity of the device 1 Before you plug in the device verify that the LUA lamp is correctly inserted into the handpiece A spring mechanism allows the lamp to retract when...

Страница 11: ...ime to replace the LUA lamp The unit pulse counter will not reset Client Records Keeping records is very important for client satisfaction We recommend tracking The energy level used during the last p...

Страница 12: ...Energy levels should always be set according to your client s comfort level Since at first FSD Plus may feel uncomfortably hot on the skin it is very important to be cautious and continually test your...

Страница 13: ...ve the handpiece due to discomfort before the sequence is completed Whatever level you treat at your client s comfort level should be the guide to the energy level setting Important Notes skin types 4...

Страница 14: ...th or as needed 5 Operating Instructions Test Always test your client s reaction to FSD Plus before beginning the actual treatment Deliver 1 3 pulses in discreet areas and wait at least 24 hours up to...

Страница 15: ...ress the power switch found on the top of the device When the Ready indicator lights up start treatment 4 Using light pressure place the handpiece on the skin Make sure to stretch the skin where you a...

Страница 16: ...a pulse sequence remove the handpiece from the skin for about 10 seconds to allow the Light Unit Assembly to cool down Apply the next sequence only when the Ready indicator lights up Placing the handp...

Страница 17: ...ing sure to begin at the initial starting point with the handpiece held vertically 9 When treatment is complete turn the device off by pressing the power switch Notes Wait 5 minutes between two consec...

Страница 18: ...eated with a bleaching agent Stay out of the sun until the hyperpigmentation condition resolves 6 Maintenance Cleaning Always unplug the device prior to cleaning it Use only a specially formulated cle...

Страница 19: ...hen pushed in and released Fuse Replacement Should the device turn off unexpectedly or fail to operate when you have plugged it in and pushed the on off switch it is possible that you may have a blown...

Страница 20: ...pulse rate within a sequence slows down or if the charging and ready indicators turn on and off repeatedly the device may be overheated Turn off the device for 30 minutes to allow it to cool down If...

Страница 21: ...Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance 3rd Ed IEC60601 1 2005 EN60601 1 2006 Electromagnetic Compatibility IEC 60601 1 2 2007 EU Directive...

Страница 22: ...Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 FSD uses RF energy only for its internal function Therefore its RF emissions are very low and are not likel...

Страница 23: ...public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital Environment Voltage dips short interruptions and voltage variations on power supply i...

Страница 24: ...as determined by an electromagnetic site surveya should be less than the compliance level in each frequency ranged Interference may occur in the vicinity of equipment marked with the following symbol...

Страница 25: ...quency of transmitter meters m 150kHz to 80MHz d 1 17 P 80MHz to 800MHz d 1 17 P 800MHz to 2 5GHz d 2 34 P 0 12 0 12 0 24 0 37 0 37 0 74 1 17 1 17 2 34 3 7 3 7 7 4 11 7 11 7 23 4 For transmitters rate...

Страница 26: ...HE Light and Heat Energy Pulse duration 1 6 msec Energy 1 2 J cm2 per pulse in a train of 5 8 10 pulses Fluence High 12 J cm2 in one working cycle 6 7Sec Medium 9 6 J cm2 in one working cycle 5 3 Sec...

Страница 27: ...27 Operation Conditions Temperature 5 C 30 C Humidity 30 RH 80 RH Transport Storage Temperature 20 C 80 C Humidity 0 RH 95 RH Atmospheric Pressure 0 1 atm 1 5 atm...

Страница 28: ...ttention Consult accompanying documents Degree of protection against electric shock Type BF applied part 100 115VAC Voltage sticker appearing on outer package On Off sign Class II equipment double ins...

Страница 29: ...tem parts and some usage warnings Label Location Located at the bottom of the system this label includes manufacturer s details voltage information and the system s serial number Located on the rear p...

Страница 30: ...er 888 661 2220 Tel 1 845 398 1647 Fax 1 845 398 1648 info radiancy com Radiancy Israel Ltd 5 Hanagar Street 45240 Hod Hasharon Israel Tel 972 9 775 7500 Fax 972 9 775 7511 E mail service radiancy com...

Страница 31: ...ils Name Serial Number Street Purchase Date City Comments State Province Country Zip Code Tel Fax Mobile E mail Was the system received without visible external damage Yes No Please describe Did the s...

Страница 32: ...LIT 00103 Rev A00 March 2013 Smart Skin Solutions...

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