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Summary of Contents for Acteon MINILED ACTIVE
- Page 1 User Manual MINILED ACTIVE...
- Page 2 This document is an English translation of the original French version. Reference J05270 version V7 and drawing number NG41FR010G...
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Page 3: Table Of Contents
6.4 Using the medical device 6.5 Switching off the medical device 6.6 Disconnecting the medical device 7 Medical device description 7.1 Light indicator 7.2 MINILED ACTIVE 7.3 Buttons 7.4 Wave peak 7.5 Wave form 7.6 Cure depth 7.7 Mains adapter 8 Disinfection and sterilising 8.1 Clean and disinfect the medical device... - Page 4 11.6 Environmental characteristics 11.7 Environmental restrictions 11.8 Main performance characteristics 12 Regulations and standards 12.1 Applicable standards and regulations 12.2 Medical class of the device 12.3 Symbols 12.4 Quick Start and Quick Clean symbols 12.5 Manufacturer identification 12.6 Manufacturer responsibility 12.7 Branch addresses 12.8 Disposal and recycling 13 Index...
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Page 5: Documentation
All paper or electronic documentation relating to your medical device must be kept for the device’s entire service life. Keep the original documentation for your medical device and its accessories for future reference. When loaning out or selling the medical device, the documentation must be provided with it. User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 3/34... - Page 6 Page 4/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 7: Required Information
2.3 Using accessories not supplied by the manufacturer The MINILED is designed to be used with SATELEC, a company of Acteon group accessories. The use of optical guides, protection shields or mains adapters made by other manufacturers will damage the MINILED. - Page 8 Page 6/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 9: Unpacking The Medical Device
If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected. If you have any questions or requirements, contact your supplier. The MINILED ACTIVE includes the following items: A 7.5 mm-diameter multi-fibre optical guide with its ferrule... - Page 10 Page 8/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 11: Installing The Medical Device
After its initial installation, the medical device is not designed to be moved. The medical device must be fixed to ensure that it cannot be removed or moved without the use of a tool. User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 9/34... - Page 12 Page 10/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 13: Connect The Medical Device
Plug the mains adapter plug into the MINILED. 5.3 Charge the battery The MINILED operates with a Lithium-Ion battery. To guarantee optimum use, this battery must be fully charged before use but must never be flat. User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 11/34... - Page 14 Page 12/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 15: Dispensing A Treatment
Install the rigid protection shield. Wear safety goggles and protective gloves. Provide your patient with safety goggles. Your MINILED ACTIVE is now ready to use. 6.3 Connect the accessories. You will hear a click when the optical guide is correctly inserted. -
Page 16: Using The Medical Device
Press the ON/OFF button and hold it down until the light indicator goes out. 6.6 Disconnecting the medical device Before a long absence or when not in use, the medical device must be cleaned and disconnected from the mains power. Page 14/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G... -
Page 17: Medical Device Description
MINILED on and off. 7.4 Wave peak Opalescent optical guide Wave peak 452 nm Maximum irradiance at 2 mm of 400 nm to 515 nm 1,464 mW / cm Average spectral irradiance 1,492 mW / cm User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 15/34... -
Page 18: Wave Form
The mains adapter is part of the medical device and helps to ensure its electrical safety. It must be installed near the medical device and must be readily accessible. The mains cord connects the mains adapter to the medical device Only use the mains adapter supplied with your medical device. Page 16/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G... -
Page 19: Disinfection And Sterilising
The instructions relating to cleaning, disinfection and sterilisation protocols for accessories supplied by SATELEC, a company of Acteon group have been approved for each medical device and accessory. The applicable guides are listed in the chapter Associated documentation page 3. - Page 20 Page 18/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 21: Monitoring And Routine Maintenance
It is important to regularly check that the lamp is working correctly. This can be done using a purpose-designed tester. Refer to the chapter Using the medical device page 14 for the procedure to follow. User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 19/34... - Page 22 Page 20/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 23: Identifying Incorrect Operation
10.4 Other malfunctions If the MINILED ACTIVE is not working for any other reason, contact the Acteon Customer Services Team. If you need to return your MINILED, please ensure the optical guide and battery are suitably packed to prevent any impact damage during transportation. - Page 24 Page 22/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 25: Technical Specifications Of The Medical Device
Thermal safety of the handpiece - The medical device stops if the Safety temperature of the surface of the handpiece reaches 41°C Type Distance with user 0 cm - 70 cm Ingress protection rating IPX0 11.5 Battery Type Lithium-ion User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 23/34... -
Page 26: Environmental Characteristics
Wavelength between 440 nm and 460 nm, plus or minus 20 nm, depending on the batch of LEDs. Maximum irradiance at 2 mm of 1464 mW/cm , calculated based on the active diameter of 6.8 mm with the opalescent optical guide. Page 24/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G... -
Page 27: Regulations And Standards
Always wear safety goggles Always wear protective gloves Refer to the supporting documentation Consult the User Manual The accompanying documentation is available in electronic format Pressure limit Humidity limit Packaging unit Fragile, handle with care User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 25/34... - Page 28 Type B part in contact Class II Direct current Direct current supply connector Electromagnetic interference CE marking Year of manufacture YYYY Manufacturer Do not dispose of as household waste Recycle your lamps and professional electrical equipment with Récylum Page 26/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 29: Quick Start And Quick Clean Symbols
Use an ultrasonic tank for cleaning. Use a swab for cleaning Use deionised or osmosis-purified water for cleaning Use an alcohol disinfectant wipe for pre-disinfection and cleaning. Clean under running water Use a washer-disinfector for cleaning and disinfection Page 27/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G... -
Page 30: Manufacturer Identification
Maintenance or repair procedures performed by people who are unauthorised by the manufacturer. Use of the device for purposes other than those specified in this manual. Use of accessories or handpiece not supplied by SATELEC, a company of Acteon group . Non-compliance with the instructions contained in this document. - Page 31 ACTEON LATINA AMERICA 124 Gaither Drive, Suite 140 Bogotà - COLOMBIA Mount Laurel, NJ 08054 - USA Mobile: +57 312 377 8209 Tel. +1 856 222 9988 info.latam@acteongroup.com Fax. +1 856 222 4726 info.us@acteongroup.com Page 29/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 32: Disposal And Recycling
When your medical device has reached the end of its service life, contact your nearest dental equipment dealer, or the Acteon head office or one of the company branches to find out how to proceed. The relevant contact details are given in the chapter Branch addresses page 28. -
Page 33: Index
5 rigid protection shield 7 fault 19 first inclusion of CE marking 5 slope of five degrees 9 gas-filled atmosphere 24 temperature 24 handpiece 7 update 5 User Manual 3 incorrect operation 21 User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G - Page 31/34... - Page 34 Page 32/34 - User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G...
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Page 35: Glossary
Often confused with the power of a light source electroluminescent diode, more commonly known as Led (light-emitting diode). Designates an optoelectronic component that allows the emission of monochromatic light User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G -Page 33/34... - Page 36 User Manual | MINILED ACTIVE | J05271 | V7 | (17) | 05/2018 | NG41EN010G SATELEC S.A.S. A Company of the ACTEON Group 17 av. Gustave Eiffel BP 30216 33708 MERIGNAC cedex FRANCE Tel. +33 (0) 556 34 06 07 Fax. +33 (0) 556 34 92 92 E-mail: satelec@acteongroup.com www.acteongroup.com...
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