Acteon Mini LED Manuale utente

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®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®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;

lelectromagnetic compatibility;

ldisposal and recycling of the medical device;

lmanufacturer 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:

lpreparation of parts for sterilisation;

ldetailed manual and automated instructions;

linformation concerning conditioning for sterilisation;

lrecommendations for the inspection of parts.

1 Documentation

This document contains the following information:

lindications for use;

lmedical device description;

lmedical device installation;

lmedical device use;

lpreparation prior to cleaning and disinfecting the medical device;

lmonitoring and general maintenance of the medical device;

lmaintenance to be performed by the user.

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 SATELEC®Mini LED optical guide J02941

Cleaning and disinfection instructions for the SATELEC®Mini LED rigid protection shield J05541

General instructions relating to the SATELEC®complete range of table curing lamps J02921

Consulting electronic user instructions J00000

Mini LED™ User Manual J02541

User Manual • Mini LED™ • J02541 • V5 • 07 • 01/2015 • NG13EN010E - Page 5/30

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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 document update

01/2015

2.5 Repairing or modifying the medical device

Contact the supplier of your device. Using the services of an unapproved repairer could render your device

dangerous for you and your patients.

Do not repair or modify the device without seeking the prior permission of SATELEC®.

If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical

device is still safe to use.

In the event of doubt, contact an approved dealer or the SATELEC®customer service team:

www.acteongroup.com

[email protected]

SATELEC®at the request of technical personnel working for the network of dealers approved by

SATELEC®, provides all information required to repair the faulty parts on which they may perform

repairs.

2.6 Warranty

The user must not disassemble the base, the battery or the handpiece as this will invalidate the medical

device's warranty.

2.7 Accessory usage conditions

The optical guide must be cleaned and sterilised being being used. The rigid protection shield must be cleaned

before being used.

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