Mini LED User Manual

User Manual

Mini LED™

This document is an English translation of the original French version. Reference J02540 version V5 and drawing number NG13FR010E

Contents

1 Documentation ..... 5
1.1 Associated documentation ..... 5
2 Required information ..... 7
2.1 Indication for use ..... 7
2.2 Operating principle ..... 7
2.3 Date of first inclusion of EC marking ..... 7
2.4 Latest document update ..... 7
2.5 Repairing or modifying the medical device ..... 7
2.6 Warranty ..... 7
2.7 Accessory usage conditions ..... 7
3 Removal from packaging, installation, connections ..... 9
3.1 Removing the medical device from its packaging ..... 9
3.2 Installing the medical device ..... 10
3.3 Connecting the medical device to the electrical network ..... 10
3.4 Installing the mains adapter ..... 10
4 Medical device description ..... 11
4.1 First use ..... 11
4.2 Using the Mini LED ..... 11
4.3 Mini LED™ ..... 11
4.4 Connecting and disconnecting accessories during use ..... 12
4.5 Light indicator ..... 12
4.6 Buttons ..... 12
4.7 Base ..... 12
4.8 Mains Adapter ..... 12
4.9 Operating modes ..... 13
4.9.1 Wave peak ..... 13
4.9.2 Waveform in each mode ..... 13
4.10 Switching off the medical device ..... 14
4.11 Disconnecting the medical device ..... 14
5 Cleaning, disinfecting and sterilising ..... 15
5.1 Cleaning and disinfecting the Mini LED ..... 15
5.2 Cleaning, disinfecting and sterilising accessories ..... 15
6 Monitoring and general maintenance of the medical device ..... 17
7 Maintenance ..... 19
7.1 Checking the lamp power level ..... 19
7.2 Identifying incorrect operation ..... 19
7.2.1 Not working ..... 19
7.3 The power of the Mini LED is not as expected ..... 19
7.4 Other malfunctions ..... 20
8 Technical specifications of the medical device ..... 21

8.1 Identification ..... 21
8.2 Mains Adapter ..... 21
8.3 Optical Guide ..... 21
8.4 Mini LED handpiece ..... 21
8.5 Technical specifications of the battery ..... 22
8.6 Charging base ..... 22
8.7 Environmental characteristics ..... 22
8.8 Environmental restrictions ..... 22
8.9 Main performance characteristics ..... 22
9 Regulations and standards ..... 23
9.1 Official Texts ..... 23
9.2 Medical class of the device ..... 23
9.3 Symbols ..... 23
9.4 Manufacturer identification ..... 24
9.5 Branch addresses ..... 25
9.6 Disposal and recycling ..... 26
10 Index ..... 27
11 Glossary ..... 29

Foreword

The SATELEC $ ^{\circledR} $ 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 your medical device's technology, please read the documentation provided carefully.

Please refer to the instructions for the entire range of SATELEC $ ^{\circledR} $ Mini LED for information about the following:

• documentation format;

• documentation archiving period;

• warnings concerning user and patient populations;

• treatment area:

• medical device usage interactions, contraindications and prohibitions;

• electromagnetic compatibility;

• disposal and recycling of the medical device;

• manufacturer responsibility.

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:

• preparation of parts for sterilisation;

• detailed manual and automated instructions;

• information concerning conditioning for sterilisation;

• recommendations for the inspection of parts.

1 Documentation

This document contains the following information:

• indications for use;

• medical device description;

• medical device installation;

• medical device use;

• preparation prior to cleaning and disinfecting the medical device;

monitoring and general maintenance of the medical device;

maintenance to be performed by the user.

1.1 Associated documentation

This document must be used in association with the following documents:

2 Required information

2.1 Indication for use

This medical device is designed to cure photosensitive reconstruction and bonding materials used in dentistry. The target clinical uses relate to conservative and restorative dentistry.

This medical device is used with an optical guide and a rigid protection shield.

2.2 Operating principle

Designed to light-cure dental materials, the Mini LED is fitted with electroluminescent diodes (LED) that emit a visible blue light in a spectrum of wavelengths between 440 nm - 460 nm. A removable optical guide is attached to the end of the medical device. The optical guide concentrates and directs the light produced to the clinical site.

The wavelength of the light source corresponds to that of the photo-initiators used in dental curing materials.

2.3 Date of first inclusion of EC marking

2007

2.4 Latest