Acteon Cube LED Manual de usuario

User Manual

Cube LED handpiece

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

Reference J28820 version V3 and drawing number NO40FR030C

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

2.9 Accessory usage conditions 5

3 Unpacking the medical device 7

4 Installing the medical device 9

4.1 Handpiece 9

4.2 Handpiece cord 9

4.3 Connecting the handpiece 9

4.4 Attaching a tip 9

5 Dispensing a treatment 11

5.1 Accessory usage conditions 11

5.2 Preparation for use 11

6 Disinfection and sterilising 13

6.1 Clean and disinfect the medical device 13

6.2 Cleaning, disinfecting and sterilising accessories 13

7 Monitoring and routine maintenance 15

7.1 Cleaning the irrigation system 15

8 Identifying incorrect operation 17

8.1 No spray 17

8.2 Ultrasounds not working 17

8.3 Water leakage 17

8.4 No light 17

9 Technical specifications of the medical device 19

9.1 Identification 19

9.2 Handpiece 19

9.3 Light 19

9.4 Length of cords 19

9.5 Irrigation 19

9.6 Environmental characteristics 19

9.7 Environmental restrictions 19

9.8 Main performance characteristics 19

10 Regulations and standards 21

10.1 Applicable standards and regulations 21

10.2 Medical class of the device 21

10.3 Symbols 21

10.4 Quick Start and Quick Clean symbols 22

10.5 Manufacturer identification 23

10.6 Branch addresses 24

10.7 Disposal and recycling 25

11 Index 26

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

Cube LED handpiece Quick Start-Clean guide J87580

Cube LED handpiece user manual J28821

Cleaning, disinfection and sterilisation instructions for tips J02001

Cleaning, disinfection and sterilisation instructions for keys J81001

Cleaning, disinfection and sterilisation instructions for the Handpiece-piezotome cord assembly J12801

Consulting electronic user instructions J00007

General instructions relating to the complete range of dental ultrasonic generators J00051

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.

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2 Required information

2.1 Indication for use

The dental surgery ultrasonic handpiece is used with a dental surgery piezoelectric ultrasonic generator and a tip.

Mechanical vibrations are transmitted to an intraoral surgery dental tip attached to the end of the ultrasonic

handpiece.

The treatments performed with this medical device are those described in the User Manual for your ultrasonic

generator.

2.2 Operating principle

This handpiece works on piezoelectric ultrasonic generators designed for dental surgery procedures.

An electrical signal emitted by the medical device is supplied to the ultrasonic handpiece. This is connected to the

medical device via a cord. The handpiece comprises a piezoelectric ceramic transducer, which transforms the

electrical signal into ultrasonic vibrations.

2.3 Using accessories not supplied by the manufacturer

The handpiece is designed to operate with SATELEC, a company of Acteon group dental surgery tips. The use of tips

made by other manufacturers will damage the handpiece, break tips and void the warranty.

2.4 Connecting and disconnecting accessories during use

Do not tighten or loosen the tips when the handpiece is activated.

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

Only clearly indicated parts of the medical device can be unscrewed by the user. Unscrewing any other parts may void

the warranty.

2.7 Latest document update

03/2018

2.8 Date of first CE marking

2017

2.9 Accessory usage conditions

The accessories and the handpiece must be cleaned, disinfected and sterilised before use.

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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 handpiece includes the following items:

la handpiece and its cord;

la Quick Start-Clean for the [J87580] handpiece-cord assembly.

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