Acteon Mini LED User manual

User Manual
Mini LED™

This document is an English translation of the original French version.
Reference J02540 version V8 and drawing number NG13FR010H

Contents
1 Documentation 5
1.1 Associated documentation 5
1.2 Electronic documentation 5
2 Required information 7
2.1 Indication for use 7
2.2 Operating principle 7
2.3 Using accessories not supplied by the manufacturer 7
2.4 Connecting and disconnecting accessories during use 7
2.5 Repairing or modifying the medical device 7
2.6 Warranty 7
2.7 Latest document update 7
2.8 Date of first CE marking 7
3 Unpacking the medical device 9
3.1 Precautions for use 9
4 Installing the medical device 11
4.1 Fixing the medical device to a non-removable support 11
5 Connect the medical device 13
5.1 Connecting the medical device to the electrical network 13
5.2 Mains adapter 13
5.3 Charge the battery 13
6 Dispensing a treatment 15
6.1 Accessory usage conditions 15
6.2 First use 15
6.3 Connect the accessories. 16
6.4 Using the medical device 16
6.5 Switching off the medical device 16
6.6 Disconnecting the medical device 16
7 Medical device description 17
7.1 Light indicator 17
7.2 Mini LED™ 17
7.3 Base 17
7.4 Operating mode 17
7.5 Buttons 18
7.6 Wave peak 18
7.7 Wave form 19
7.8 Cure depth 19
7.9 Mains adapter 19
8 Disinfection and sterilising 21
8.1 Clean and disinfect the medical device 21
8.2 Cleaning, disinfecting and sterilising accessories 21
9 Monitoring and routine maintenance 23
9.1 Check the power 23
10 Identifying incorrect operation 25
10.1 Not working 25
10.2 Charging base not working 25
10.3 Optical Guide 25
10.4 The power is not as expected 25
10.5 Malfunction of the power tester 26
10.6 Other malfunctions 26
11 Technical specifications of the medical device 27
11.1 Identification 27

11.2 Mains Adapter 27
11.3 Optical Guide 27
11.4 Handpiece 27
11.5 Battery 27
11.6 Base 28
11.7 Environmental characteristics 28
11.8 Environmental restrictions 28
11.9 Main performance characteristics 28
12 Regulations and standards 29
12.1 Applicable standards and regulations 29
12.2 Medical class of the device 29
12.3 Symbols 29
12.4 Manufacturer identification 31
12.5 Manufacturer responsibility 31
12.6 Branch addresses 32
12.7 Disposal and recycling 33
13 Index 35
14 Glossary 37

Foreword
The medical device that you are about to install and use in your practice is a medical device
designed for professional use. It is therefore a key tool with which you will provide treatment within
the context of your work.
To ensure optimum safety for yourself and your patients, comfort in your daily practice and to
benefit fully from the technology of your medical device, please read the documentation provided
carefully.
Please refer to the cleaning, disinfection and sterilisation instructions for accessories and to the
cleaning, disinfection and sterilisation instructions for Mini LEDs for information about the following:
lPreparation of parts for sterilisation
lDetailed manual and automated instructions
lInformation concerning conditioning for sterilisation
lRecommendations 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:
lDocumentation format
lDocumentation archiving period
lWarnings concerning user and patient populations
lTreatment area
lMedical device usage interactions, contraindications and prohibitions
lDisposal and recycling of the medical device
lManufacturer responsibility