Acteon Newtron Slim B. LED User manual

User Manual
SLIM & Slim B.LED handpiece

This document is an English translation of the original French version.
Reference J12920 version V6 and drawing number NBAFFR030F

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 8
2.8 Date of first CE marking 8
2.9 Accessory usage conditions 8
3 Unpacking the medical device 9
4 Installing the medical device 11
4.1 Handpiece 11
4.2 Handpiece cord 11
4.3 Connecting the ultrasonic 11
4.4 Attaching a tip or a file 11
5 Dispensing a treatment 13
5.1 Accessory usage conditions 13
5.2 Preparation for use 13
6 Disinfection and sterilising 15
6.1 Clean and disinfect the medical device 15
6.2 Cleaning, disinfecting and sterilising accessories 15
7 Monitoring and routine maintenance 17
7.1 Cleaning the irrigation system 17
7.2 Corrective Maintenance 17
7.2.1 Replacing the handpiece seal 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 Light 21
9.4 Length of cords 21
9.5 Irrigation 21
9.6 Environmental characteristics 21
9.7 Environmental restrictions 21
9.8 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 26
10.5 Branch addresses 27
10.6 Disposal and recycling 28
11 Index 30

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 sterilisation instructions for accessories and to the
cleaning, disinfection and sterilisation instructions for handpieces 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
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 and patient populations
lTreatment area
lMedical device usage interactions, contraindications and prohibitions
lDisposal and recycling of the medical device
lManufacturer responsibility
Please refer to the User Manuals, Quick Start Guides and Quick Clean Guides for each medical
device for information about the following:
lUnpacking and installing the medical device
lUsing the medical device
lMonitoring and maintaining the medical device
lTechnical specifications of the medical device

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
Consulting electronic user instructions J00007
General instructions relating to the complete range of dental ultrasonic generators J00011
Cleaning, disinfection and sterilisation instructions for handpieces J12911
Cleaning, disinfection and sterilisation instructions for wrenches J81001
Cleaning, disinfection and sterilisation instructions for tips J02001
SLIM handpiece user manual J12921
SLIM handpiece Quick Start-Clean guide J12930
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 ultrasonic handpiece is used in association with a conventional dental piezoelectric ultrasonic generator
and a tip or a dental file.
The treatments performed with this medical device are those described in the User Manual for your ultrasonic
generator.
2.2 Operating principle
This handpiece is available in the Newtron SLIMand Newtron SLIM B.LED versions and works on piezoelectric
ultrasonic generators fitted with a SLIM connector and an electronic LED.
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.
The Newtron SLIM B.LED fitted with its Blue LED ring and used in conjunction with the F.L.A.G. for B.LED fluorescent
liquid, shows up dental plaque during the scale removal or dental prophylaxis phase. Fitted with a white LED ring, the
handpiece emits a white light providing the user with optimum visibility of the treatment area.
2.3 Using accessories not supplied by the manufacturer
The handpiece is designed to operate with SATELEC, a company of Acteon group dental tips and files. The use of tips or
files made by other manufacturers will damage the handpiece, break tips and files 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.
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2.7 Latest document update
09/2017
2.8 Date of first CE marking
2013
2.9 Accessory usage conditions
The accessories and the handpiece must be cleaned, disinfected and sterilised 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 SLIM handpiece includes the following items:
la SLIM handpiece;
ldepending on the option you chose, a blue LED ring installed and an interchangeable white LED ring;
la Quick Start- Clean guide for the handpiece SLIM [J12930].
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4 Installing the medical device
4.1 Handpiece
The handpieces are designed to operate exclusively with SATELEC dental ultrasonic generators.
There is a handpiece with SLIM B.LED to white LED connector and a handpiece with SLIM B.LED to blue LED connector.
4.2 Handpiece cord
The SLIM cord is only compatible with Acteon handpieces with SLIM connector.
The cord ensures irrigation circulation and electrical connection between the medical device and the handpiece.
Never rotate the handpiece connector on its cord as this can damage your medical device.
Never wrap the handpiece cord around the medical device.
Make sure that it is not possible to wheel over or walk on the different cords.
The cord attached to its handpiece must be easily accessible. Make sure that the cord is slack during use.
4.3 Connecting the ultrasonic
Check for any traces of humidity on the handpiece connections.If the connections are damp, dry them with the multi-
purpose syringe.
Lubricate the irrigation circuit seal located on the metal shaft on the back of the handpiece with silicone paste.
This will prolong its service life and prevent leaks. Do not use spray lubricant on dental instruments.
Place the handpiece on the support.
4.4 Attaching a tip or a file
A tip or a file vibrates correctly when it is perfectly tightened without being forced beyond its stop point. Tighten the tip
with the torque wrench (F81320, F81321, F81322 or F81323) to ensure optimum ultrasonic function. Over-tightening of
the tip or file with the open-ended wrench can result in breakage of the tip, file or handpiece.
To prevent self-locking of the tip or the file, the latter must be removed and sterilised after each use.
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The torque wrenches must be replaced every year.
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5 Dispensing a treatment
5.1 Accessory usage conditions
The accessories and the handpiece must be cleaned, disinfected and sterilised prior to each use.
Refer to the cleaning, disinfection and sterilisation 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 sterilisation bag.
4. Remove the wrench from its sterilisation bag.
5. Remove the tip from its sterilisation bag.
6. Screw the tip onto the handpiece, first manually and finishing with the wrench.
7. Connect the handpiece to the handpiece cord socket.
8. Place the handpiece on its support..
9. Switch on the medical device.
10. Check the irrigation parameters depending on the tip chosen.
11. After water drainage, check that the spray works correctly.
Your medical device is now ready to use.
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6 Disinfection and sterilising
The instructions relating to cleaning, disinfection and sterilisation 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 sterilisation 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's control unit must be cleaned and disinfected daily.
The handpiece must be cleaned, disinfected and sterilised after each use.
Do not immerse the handpiece.
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.
Use alcohol disinfectant wipes.
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.
6.2 Cleaning, disinfecting and sterilising accessories
Refer to the cleaning, disinfection and sterilisation 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.
Check the condition of the handpiece rear seals, which must not be distended, torn or broken.
Before and after use, check the medical device and its accessories entirely 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 two minutes.
7.2 Corrective Maintenance
7.2.1 Replacing the handpiece seal
Remove the faulty seal from the water connector using a thin pair of pliers.
Install the new seal using the purpose-designed kit as shown below.
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