Acteon MINILED ACTIVE Bedienungsanleitung

User Manual

MINILED ACTIVE

This document is an English translation of the original French version.

Reference J05270 version V7 and drawing number NG41FR010G

Contents

1 Documentation 3

1.1 Associated documentation 3

1.2 Electronic documentation 3

2 Required information 5

2.1 Indication for use 5

2.2 Operating principle 5

2.3 Using accessories not supplied by the manufacturer 5

2.4 Connecting and disconnecting accessories during use 5

2.5 Repairing or modifying the medical device 5

2.6 Warranty 5

2.7 Latest document update 5

2.8 Date of first CE marking 5

3 Unpacking the medical device 7

3.1 Precautions for use 7

4 Installing the medical device 9

4.1 Fixing the medical device to a non-removable support 9

5 Connect the medical device 11

5.1 Connecting the medical device to the electrical network 11

5.2 Mains adapter 11

5.3 Charge the battery 11

6 Dispensing a treatment 13

6.1 Accessory usage conditions 13

6.2 Preparation for use 13

6.3 Connect the accessories. 13

6.4 Using the medical device 14

6.5 Switching off the medical device 14

6.6 Disconnecting the medical device 14

7 Medical device description 15

7.1 Light indicator 15

7.2 MINILED ACTIVE 15

7.3 Buttons 15

7.4 Wave peak 15

7.5 Wave form 16

7.6 Cure depth 16

7.7 Mains adapter 16

8 Disinfection and sterilising 17

8.1 Clean and disinfect the medical device 17

8.2 Cleaning, disinfecting and sterilising accessories 17

9 Monitoring and routine maintenance 19

9.1 Check the power 19

10 Identifying incorrect operation 21

10.1 Not working 21

10.2 Optical Guide 21

10.3 The power is not as expected 21

10.4 Other malfunctions 21

11 Technical specifications of the medical device 23

11.1 Identification 23

11.2 Mains Adapter 23

11.3 Optical Guide 23

11.4 Handpiece 23

11.5 Battery 23

11.6 Environmental characteristics 24

11.7 Environmental restrictions 24

11.8 Main performance characteristics 24

12 Regulations and standards 25

12.1 Applicable standards and regulations 25

12.2 Medical class of the device 25

12.3 Symbols 25

12.4 Quick Start and Quick Clean symbols 27

12.5 Manufacturer identification 28

12.6 Manufacturer responsibility 28

12.7 Branch addresses 28

12.8 Disposal and recycling 30

13 Index 31

14 Glossary 33

1 Documentation

This document contains the following information:

lIndications for use

lMedical device description

lInstallation of the medical device

lMedical device use

lPreparation for cleaning and disinfection of 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 MINILED optical guide J02941

Cleaning and disinfection instructions for the MINILED rigid protection shield J05541

General instructions relating to the complete range of table curing lamps J05102EN

Consulting electronic user instructions J00007

MINILED ACTIVE User manual J05271

Cleaning and disinfection instructions for the MINILED flexible protection shield J05551

The Quick Start and Quick Clean documents are summaries created for your approval.The only binding

instructions are the user manuals and regulatory documentation associated with the medical device.

1.2 Electronic documentation

The user instructions for your device are available in electronic format on the specified website and not in printed

format. If the website is unavailable, try again later. You can also request a free printed copy of the user instructions

within seven days via our website, by telephone or in writing.

The electronic user instructions are available in PDF format (Portable Document Format). You will need to have a PDF

file reader installed to read the electronic user instructions. It is important for you to have read and understood the

content of the user instructions relating to the use of your device and its accessories.

Never use your device without first reading the user instructions.

The device user instructions can be consulted at the following addresses:www.ultradent.com and www.satelec.com.

When you receive your device, you are asked to print and/or to download all documents or sections of documents that

you may need to refer to in the event of an emergency, if you are unable to connect to the internet or if your electronic

display tool is not working (computer, tablet, etc.). We recommend that you visit the website regularly to consult and to

download the latest version of your device's user instructions. Users are asked to keep documentation close at hand

for reference when necessary.

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.

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2 Required information

2.1 Indication for use

This medical device is designed to cure photosensitive composites and bonding composites 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 MINILED ACTIVE is fitted with electroluminescent diodes (LED) that emit a

visible blue light in a spectrum of wavelengths between 440 - 460 nm +/-20 nm, depending on the batch of LEDs.

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

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.

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.

2.4 Connecting and disconnecting accessories during use

Do not disconnect the optical guide or the rigid protection shield when using your MINILED.

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, a company of Acteon group.

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, a company of Acteon group Customer Service team:

www.acteongroup.com

[email protected]

SATELEC, a company of Acteon group, at the request of technical personnel working for the network of

approved dealers, will provide any information required to repair defective parts on which they may perform

repairs.

2.6 Warranty

The rigid protection shield and the optical guide are the only parts the user can disassemble. The disassembly of any

other parts will invalidate the medical device's warranty.

2.7 Latest document update

05/2018

2.8 Date of first CE marking

2017

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3 Unpacking the medical device

When you receive your medical device, check for any damage that may have occurred during transportation.

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:

lA 7.5 mm-diameter multi-fibre optical guide with its ferrule

lA handpiece MINILED with integrated battery

lA protection plug for the handpiece

lA rigid protection shield

lA mains adapter and its plugs

lA list of references for each part [J05101]

lA Quick Start-Clean MINILED [J05100]

3.1 Precautions for use

Never point the medical device directly at the eyes even when it is not in use.

The MINILED is powered by a built-in battery. Take the following precautions to protect your own safety:

lDo not remove, open or tear any parts of the MINILED.

lDo not expose the MINILED to sunlight, heat or fire.

lNever short-circuit your MINILED.

lDo not store your MINILED in a box or a drawer, where it could be short-circuited by other metal objects.

lIf the battery of the MINILED leaks, avoid contact between the fluid and the skin or eyes. In the event of contact,

rinse thoroughly and refer to a doctor.

lRegularly wipe the power supply connector with a soft and dry cloth.

lAfter lengthy storage, charge and discharge the MINILED several times in order to achieve maximum

performance.

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