Acteon SATELEC Newtron SLIM User manual

User Manual
Handpiece

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 Date of inclusion of EC marking 7
2.4 Latest document update 7
2.5 Repairing or modifying the device 7
2.6 Accessory usage conditions 7
3 Removal from packaging, installation, connections 9
3.1 Unpacking the device 9
4 Description of the medical device 11
4.1 SLIM handpiece 11
4.2 Attach a tip or a file 11
4.3 Connecting and disconnecting accessories during use 11
4.4 Connecting the handpiece 11
4.5 handpiece cord 11
5 Cleaning, disinfecting and sterilizing 13
6 Monitoring and maintenance of the medical device 15
7 Maintenance 17
7.1 Identifying incorrect operation 17
7.1.1 No spray 17
7.1.2 No light 17
7.1.3 Ultrasounds not working 17
7.1.4 Water leakage 17
7.1.5 Replacing the handpiece seal 17
8 Technical specifications for the medical device 19
8.1 Identification 19
8.2 SLIM handpiece 19
8.3 Irrigation 19
8.4 Environmental characteristics 19
8.5 Environmental restrictions 19
8.6 Main performance characteristics 19
9 Regulations and standards 21
9.1 Official Texts 21
9.2 Medical class of the device 21
9.3 Standardised Symbols 21
9.4 Manufacturer identification 21
9.5 Branch addresses 23

9.6 Disposal and recycling 25
9.7 Disposing of accessories 25
10 Index 27

Foreword
The medical device SATELEC®that you are about to install and use in your practice is a medi-
cal device designed for professional use. It comprises the chosen tool with which you will pro-
vide 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.
If you have received this medical device by mistake, please contact the supplier to arrange
for it to be collected.
Please refer to the accessory cleaning, disinfection and sterilization protocols and the hand-
piece predisinfection, cleaning and sterilisation protocols for information about the fol-
lowing:
lpreparation of parts for sterilization;
ldetailed manual and automatic protocols;
linformation concerning conditioning for sterilization;
lrecommendations for the inspection of parts.

1 Documentation
This document contains the following information:
lindications for use;
ldescription of the medical device;
linstallation of the medical device;
1.1 Associated documentation
This document must be used in association with the following documents:
Document title References
Cleaning, disinfection and sterilization protocols for Wrenches SATELEC®J81001
Cleaning, disinfection and sterilization protocols for Tips SATELEC®J02001
Cleaning, disinfection and sterilization protocols for Handpieces SATELEC®J12911
Method for consulting electronic user instructions J00000
User Manual for Newtron®Booster J60111
User Manual for Newtron®P5 J61101
User Manual for Newtron®P5XS J62151
Quick Start SLIM handpiece J12900
Quick Clean SLIM handpiece J12930
1.2 Electronic documentation
The user instructions for your device are provided in electronic format and not in printed format. However, you
can request a free printed copy of the user instructions within 7 days via our website, by telephone or in wri-
ting.
The electronic user instructions are available in PDF format (Portable Document Format) and you will need to
have a PDF file read software installed to read the instructions.
The device user instructions can be consulted at the following address:
www.satelec.com/documents
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 prior to use.
We recommend that you visit the website regularly to consult and/or to download the latest version of your
device's user instructions.
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2 Required information
2.1 Indication for use
The dental ultrasound handpiece is used in association with a conventional dental piezoelectric ultrasonic gene-
rator 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, in the chapitre Associated documentation page 5.
2.2 Operating principle
This handpiece is available in the Newtron®SLIMand Newtron®SLIM B.LED versions and works on pie-
zoelectric ultrasonic generators fitted with a SLIM connectorand an electronic LED.
The Newtron®SLIM B.LED fitted with its Blue LED ring and used in conjunction with the F.L.A.G.™ disclosing
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 Date of inclusion of EC marking
2013
2.4 Latest document update
04/2013
2.5 Repairing or modifying the device
Contact the supplier of your device. Using the services of an unapproved repairer could render your device dan-
gerous for you and your patients.
Do not repair or modify the SATELEC®without seeking the prior permission of .
If the device is modified or repaired, specific checks and tests must be carried out to ensure that the 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®, provide all information required to repair the faulty parts on which they may perform
repairs.
2.6 Accessory usage conditions
Accessories and SLIM handpiece must be cleaned, disinfected and sterilized prior to use.
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3 Removal from packaging, ins-
tallation, connections
3.1 Unpacking the device
When you receive your device, check for any damage that may have occurred during transportation.
If you have received this 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 guide for the handpiece [J12900];
la Quick Clean guide for the handpiece [J12930].
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4 Description of the medical device
4.1 SLIM handpiece
Only handpieces with SLIM connector SATELEC®can be connected to the medical device. There is a handpiece
with SLIM connector without LED, and a handpiece with SLIM connector B.LED with white or blue LED.
4.2 Attach a tip or a file
A tip or a file vibrates correctly when it is perfectly tightened without being forced beyond its stop point. Tigh-
ten it moderately using the wrench provided to ensure optimum ultrasound operation. Over-tightening of the
tip or file 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 after each use.
4.3 Connecting and disconnecting accessories during use
Do not connect/disconnect the cord(s) or the handpiece when the medical device is switched on and
your foot is on the pedal.
Do not tighten or loosen the tips when the handpiece is activated.
4.4 Connecting the handpiece
Check for the absence of signs of humidity at the SLIM handpiece connections, and eliminate them if necessary
(wipe and blow using a multipurpose syringe).
Lubricate the irrigation system seal located behind the SLIM handpiece with dental instrument lubricant
to extend its effectiveness and prevent leaks.
Connect the SLIM handpiece to the sleeve, by aligning the indexing points and by avoiding rotation movement.
Install the SLIM handpiece on the support.
The following solutions are approved for use:
lHydrogen peroxide < 3%;
lChlorexidine < 3%;
lEDTA Ethylenediaminetetraacetic acid < 15%;
lSodium Hypochlorite < 0.9%;
lSterile water, distilled water, deionised water, dimineralised water;
lSaline solution at 0.9%.
The following solutions must not be used:
lHextril®Hexedrin;
lBleach.
4.5 handpiece cord
The SLIM cord is only compatible with handpieces SATELEC®with SLIM connector.
The SLIM cord ensures irrigation circulation and electrical connection between the medical device and the SLIM
handpiece.
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5 Cleaning, disinfecting and ste-
rilizing
The instructions relating to accessory cleaning, disinfection and sterilization protocols provided by SATELEC®
have been approved for each medical device and accessory. The applicable guides are listed in chapitre Asso-
ciated 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 accessory cleaning, disinfection and sterilization pro-
tocols take precedence over the information provided by SATELEC®.
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6 Monitoring and maintenance of the
medical device
Before and after each use, check that the device and its accessories are not faulty in any way. This is neces-
sary to detect any isolation fault or damage. If necessary, replace damaged parts.
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7 Maintenance
7.1 Identifying incorrect operation
In the event of incorrect operation, refer to the tables below to quickly identify and repair the non-complex
parts of the medical device.
If the incorrect operation is not described in the tables below, please contact your supplier or the After-Sales
team at SATELEC®.
Do not use the medical device if it appears to be damaged or faulty. Isolate the medical device and make sure
that it cannot be used.
7.1.1 No spray
Symptoms: There is no water spray at the tip.
Possible causes Solutions
Flow configuration button on minimum Adjust the flow configuration button
Tip or file blocked Unblock the tip or file
Incorrect choice of tip Check the tip
Inadequate amount of spray Adjust the spray
7.1.2 No light
Symptoms: the SLIM handpiece does not light up.
Possible causes Solutions
Connection of a SLIM handpiece to an ultrasonic generator not
fitted with the LED function
Connect the SLIM handpiece to an ultrasonic generator
fitted with the LED function
LED ring missing Install a blue or white LED ring depending on the treat-
ment to be performed
Faulty LED ring Order and install a new LED ring
LED ring connector contacts faulty Clean the LED ring contacts
SLIM handpiece or SLIM cord connector contacts faulty Clean the SLIM handpiece and SLIM cord connector
contacts.
7.1.3 Ultrasounds not working
Symptoms: the tip does not vibrate, vibration cannot be heard.
Possible causes Solutions
Tip loose Tighten the tip using the wrench
Faulty connector contact Clean the cord contacts
Handpiece cord wire(s) cut Return to After-Sales Department SATELEC®to replace the cord
7.1.4 Water leakage
Symptoms: Water is leaking from one of the following places:
lbetween the base of the SLIM handpiece and its cord
Possible causes Solutions
Wear of 1.15mm x1mm SLIM handpiece
seal
Replace the seal using F12304 kit. Refer to the instructions in document
J12921
7.1.5 Replacing the handpiece seal
Remove the faulty seal from the water connector using a thin pair of pliers.
Install the new seal using kit F12304 as shown below.
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