Table of Contents
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Table of Contents
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Summary of Contents for Acteon Mini LED
- Page 1 User Manual Mini LED™...
- Page 2 This document is an English translation of the original French version. Reference J02540 version V8 and drawing number NG13FR010H...
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Page 3: Table Of Contents
6.3 Connect the accessories. 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 Mini LED™ 7.3 Base 7.4 Operating mode 7.5 Buttons 7.6 Wave peak 7.7 Wave form 7.8 Cure depth... - Page 4 11.2 Mains Adapter 11.3 Optical Guide 11.4 Handpiece 11.5 Battery 11.6 Base 11.7 Environmental characteristics 11.8 Environmental restrictions 11.9 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 Manufacturer identification 12.5 Manufacturer responsibility 12.6 Branch addresses 12.7 Disposal and recycling...
- Page 5 Detailed manual and automated instructions Information concerning conditioning for sterilisation Recommendations for the inspection of parts Please refer to the instructions for the entire range of SATELEC, a company of Acteon Group Mini LED for information about the following: Documentation format...
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Page 7: Documentation
1.1 Associated documentation This document must be used in association with the following documents: Document title References Cleaning, disinfection and sterilisation instructions for the Mini LED optical guide J02941 Cleaning and disinfection instructions for the Mini LED rigid protection shield J05541... - Page 8 Page 6/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 9: Required Information
2.3 Using accessories not supplied by the manufacturer The Mini LED 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 Mini LED. - Page 10 Page 8/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 11: Unpacking The Medical Device
Do not store your Mini LED in a box or a drawer, where it could be short-circuited by other metal objects. If the battery of the Mini LED leaks, avoid contact between the fluid and the skin or eyes. In the event of contact, rinse thoroughly and refer to a doctor. - Page 12 Regularly wipe the power supply connector with a soft and dry cloth. After lengthy storage, charge and discharge the Mini LED several times in order to achieve maximum performance. Page 10/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 13: 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 | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H - Page 11/38... - Page 14 Page 12/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 15: Connect The Medical Device
Check that the cord does not hinder the movement or free circulation of anyone whilst the Mini LED is charging. Make sure that it is not possible to wheel over or walk on the cord. Plug the mains adapter plug into the Mini LED. - Page 16 Page 14/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 17: Dispensing A Treatment
Install the battery on the handpiece. Place the Mini LED on its charging base. The Mini LED is correctly installed when two beeps are heard and the green indicator light on the base starts flashing. Leave the Mini LED to fully charge. -
Page 18: Connect The Accessories
Prior to the day of use, check that you have enough sterilised optical guides and check the power output as indicated in the chapter page 23. The patient and the practitioner must wear class II safety goggles when the Mini LED is in operation. Remove the Mini LED from the base;... -
Page 19: Medical Device Description
7.3 Base The Mini LED charging base comprises a power tester. This is used to test correct operation of the Mini LED. 7.4 Operating mode Rapid mode activates maximum power of the Mini LED for ten seconds. -
Page 20: Buttons
7.5 Buttons The Mini LED has two buttons. located near the optical guide used to switch the Mini LED on and off. used to select the required operating mode. 7.6 Wave peak The waveform and its peak are identical in all three operating modes. -
Page 21: 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 19/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H... - Page 22 Page 20/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 23: Disinfection And Sterilising
SATELEC, a company of Acteon Group. 8.1 Clean and disinfect the medical device The Mini LED must be OFF during cleaning and disinfecting procedures. It must also be disconnected from its electricity supply. - Page 24 Page 22/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 25: Monitoring And Routine Maintenance
The lamp is working correctly and has a power output equal to or more than 785 mW/cm The lamp is not working correctly. Please read the chapter page 25 User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H - Page 23/38... - Page 26 Page 24/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 27: Identifying Incorrect Operation
Do not use the medical device if it appears to be damaged or faulty. Isolate the medical device and make sure that it cannot be used. 10.1 Not working Symptoms: The Mini LED does not switch on and does not emit blue light. Possible causes Solutions... -
Page 28: Malfunction Of The Power Tester
If the Mini LED™ is not working for any other reason, contact the Acteon Customer Services Team. If you need to return your Mini LED, please ensure the optical guide and battery are suitably packed to prevent any impact damage during transportation. -
Page 29: Technical Specifications Of The Medical Device
- 2400 mW / cm Irradiance with amber-coloured optical guide 785 mW / cm - 1680 mW / cm Operating mode Continuous Safety Thermal Type Ingress protection rating IPX0 11.5 Battery Type Lithium-ion User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H - Page 27/38... -
Page 30: Base
Irradiance of 785 mw / cm - 1680 mW / cm , calculated based on the active diameter of 6.8 mm with the amber- coloured optical guide. Page 28/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H... -
Page 31: Regulations And Standards
Do not use the medical device if the patient is wearing a medical device for deep brain stimulation Do not use the medical device if the patient is wearing a medical device for vagus nerve stimulation Biohazard User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H - Page 29/38... - Page 32 IP: ingress protection ratings procured by a range 4: ingress protection rating against the penetration of solids of a diameter IP40 greater than 1 mm 0: no protection against the penetration of liquids Page 30/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 33: 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 34: Branch Addresses
Chaoyang District - BEIJING 100027 - CHINA info.tw@acteongroup.com Tel. +86 10 646 570 11/2/3 Fax. +86 10 646 580 15 info.cn@acteongroup.com THAILAND ACTEON (THAILAND) LTD 23/45 Sorachai Building 16th floor - Sukumvit 63 User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H - Page 32/38... -
Page 35: 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 32. - Page 36 Page 34/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 37: Index
CE marking 7 temperature 28 gas-filled atmosphere 28 general instructions relating to the complete range of update 7 Mini LED 3 incorrect operation 25 light curing 7 User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H - Page 35/38... - Page 38 Page 36/38 - User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H...
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Page 39: 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 | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H -Page 37/38... - Page 40 User Manual | Mini LED™ | J02541 | V8 | (07) | 01/2017 | NG13EN010H SATELEC S.A.S. A Company of 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...
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