Acteon Cube LED User manual

User Manual
Handpiece

This document is an English translation of the original French version.
Reference J28820 version V1 and drawing number NO40FR030A

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
2.9 Accessory usage conditions 7
3 Unpacking the medical device 9
4 Installing the medical device 11
4.1 Handpiece 11
4.2 Connecting the handpiece 11
4.3 Screw in a tip 11
5 Dispensing a treatment 13
5.1 Accessory usage conditions 13
5.2 Preparation for use 13
6 Disinfection and sterilizing 15
6.1 Clean and disinfect the medical device 15
6.2 Cleaning, disinfecting and sterilizing accessories 15
7 Monitoring and routine maintenance 17
7.1 Cleaning the irrigation system 17
8 Identifying incorrect operation 19
8.1 No spray 19
8.2 Ultrasounds not working 19
8.3 Water leakage 19
8.4 No light 19
9 Technical specifications of the medical device 21
9.1 Identification 21
9.2 Handpiece 21
9.3 Length of cords 21
9.4 Irrigation 21
9.5 Environmental characteristics 21
9.6 Environmental restrictions 21
9.7 Main performance characteristics 21
10 Regulations and standards 23
10.1 Applicable standards and regulations 23
10.2 Medical class of the device 23
10.3 Symbols 23
10.4 Manufacturer identification 25
10.5 Branch addresses 26
10.6 Disposal and recycling 27
11 Index 29

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 sterilization instructions for accessories and to the
cleaning, disinfection and sterilization instructions for handpieces for information about the
following:
lPreparation of parts for sterilization
lDetailed manual and automated instructions
lInformation concerning conditioning for sterilization
lRecommendations for the inspection of parts
Please refer to the instructions for the entire range of SATELEC, a company of Acteon group dental
ultrasonic generators for information about the following:
lDocumentation format
lDocumentation archiving period
lWarnings concerning user population
lTreatment area
lMedical device usage interactions, contraindications and prohibitions
lDisposal and recycling of the medical device
lManufacturer responsibility

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 J87580
Cube LED handpiece user manual J12829
Cleaning, disinfection, and sterilization instructions for tips J02009
Cleaning, disinfection and sterilization instructions for wrenches J81009
Cleaning, disinfection and sterilization instructions for Piezotome handpiece-cord assembly J12809
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.satelec.com/documents
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 ultrasonic dental handpiece for intra-oral surgery is used jointly with a dental piezoelectric ultrasonic generator for
intra-oral surgery and a tip.
The clinical procedures performed with this medical device are those described in the user manual for your ultrasonic
generator.
2.2 Operating principle
This handpiece operates on the piezoelectric ultrasound generators intended for intra-oral surgical clinics.
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
This handpiece is designed to operate with SATELEC, a company of Acteon group intra-oral dental surgical tips. Any
use of other manufacturer tips will damage the handpiece and break tips and files.
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
No part of the medical device other than those clearly indicated as such may be unscrewed by the user under risk of
voiding the warranty.
2.7 Latest document update
07/2017
2.8 Date of first CE marking
2017
2.9 Accessory usage conditions
The accessories and the handpiece must be cleaned, disinfected and sterilized prior to each 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 components:
la handpiece and its cord;
la Quick Start-Clean for the handpiece and cord set [J87580].
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4 Installing the medical device
4.1 Handpiece
The Cube LED handpiece must be used in combination with an ultrasound dental generator and tips for intra-oral
surgical procedures.
4.2 Connecting the handpiece
Connect the cord and handpiece assembly to the connector on the front of the control unit.
Insert the handpiece on the support.
4.3 Screw in a tip
A tip vibrates correctly when it is perfectly tightened without being forced beyond its stop point. Tighten it moderately
using the wrench supplied to ensure optimum ultrasonic function. Over-tightening of the tip can result in breakage of
the tip or handpiece.
To prevent self-locking of the tip, the latter must be removed and sterilized after each use.
The wrench is a slip type torque wrench.After a few turns, the wrench appears to slip or to stop tightening,
which means that the tightening torque has been reached.
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5 Dispensing a treatment
5.1 Accessory usage conditions
The accessories and the handpiece must be cleaned, disinfected and sterilized prior to each use.
Refer to the cleaning, disinfection and sterilization instructions for accessories listed in the chapter Associated
documentation page 5.
5.2 Preparation for use
To prepare your medical device, follow the steps below:
1. Wear safety goggles and protective gloves.
2. Clean the unit with an alcohol disinfectant wipe.
3. Remove the handpiece from its sterilization bag.
4. Remove the wrench from its sterilization bag.
5. Remove the tip from its sterilization bag.
6. Connect the cord and handpiece assembly to the connector on the front of the control unit.
7. Put the irrigation line in place.
8. Put the irrigation pocket in place.
9. Screw the tip onto the handpiece, first manually and finishing with the wrench.
10. Place the handpiece on its support.
11. Check the irrigation parameters depending on the tip chosen.
12. Switch on the medical device.
13. After water drainage, check that the spray works correctly.
Your medical device is now ready to use.
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6 Disinfection and sterilizing
The instructions relating to cleaning, disinfection and sterilization protocols for accessories provided by SATELEC, a
company of Acteon group have been approved for each medical device and accessory. The applicable guides are listed
in the chapter Associated documentation page 5.
They can be downloaded at the following address: www.satelec.com/documents.
In all cases, the local regulations in force relating to the cleaning, disinfection and sterilization protocols for
accessories take precedence over the information provided by SATELEC, a company of Acteon group.
6.1 Clean and disinfect the medical device
The medical device must be in OFF or O stop position during cleaning and disinfecting procedures.
Refer to the instructions in the chapter Cleaning the irrigation system page 17
Avoid using cleaning and disinfection products that contain flammable agents.
Otherwise, ensure that the product has completely evaporated or that there is no fuel left on the medical device and its
accessories before switching it on.
Do not use an abrasive product to clean the medical device.
Never apply sprays directly to the medical device to clean it. Always spray the product onto a wipe, then clean
the medical device.
The handpiece and its cord must be cleaned, disinfected and sterilized after each use.
Use alcohol disinfectant wipes.
6.2 Cleaning, disinfecting and sterilizing accessories
Refer to the cleaning, disinfection and sterilization instructions for accessories listed in the chapter Associated
documentation page 5.
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7 Monitoring and routine maintenance
Check the cleanliness of the handpiece nosepiece. It must be clean, smooth and corrosion-free. The handpiece must
screw easily and firmly inside it.
Before and after use, check the medical device and its accessories thoroughly for any problems. This is necessary to
detect any electrical isolation fault or damage. If necessary, replace damaged parts.
7.1 Cleaning the irrigation system
After installation and before first use, at the end of the day and following a period of prolonged non-use of the medical
device, it is important to clean the irrigation system.
Operate the device at minimum power, at maximum irrigation flow rate for 2 minutes.
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