Acteon Newtron P5 User manual

User Manual
Newtron P5 & Newtron P5 B.LED

This document is an English translation of the original French version.
Reference J61100 version V6 and drawing number NBACFR030F

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 8
2.7 Latest document update 8
2.8 Date of first CE marking 8
3 Unpacking the medical device 9
4 Connect the medical device 11
4.1 Connecting the medical device to the water system 11
4.2 Connecting the medical device to the water system 11
4.3 Installing a water filter 11
4.4 Connecting the medical device to the electrical network 11
4.5 Connecting the medical device to the electrical network 12
5 Installing the medical device 13
5.1 Fixing the medical device to a non-removable support 13
5.2 Install cords 13
5.3 Installing the control pedal 13
5.4 Connecting the ultrasonic 13
5.5 Attaching a tip or a file 13
6 Dispensing a treatment 15
6.1 Accessory usage conditions 15
6.2 Preparation for use 15
7 Medical device description 17
7.1 Control unit 17
7.2 Light indicator 17
7.3 Handpiece 17
7.3.1 Handpiece cord 17
7.3.2 Handpiece support 17
7.4 Adjusts the power 17
7.5 Setting the irrigation flow 17
7.6 Air inlets 18
7.7 Control pedal 18
7.8 Mains Connector 18
7.9 Switch 18
8 Disinfection and sterilising 19
8.1 Clean and disinfect the medical device 19
8.2 Cleaning, disinfecting and sterilising accessories 20
9 Monitoring and routine maintenance 21
9.1 Cleaning the irrigation system 21
9.2 Clean the water filter cartridge. 21
9.3 Corrective Maintenance 22
9.3.1 Replacing the fuses 22
10 Identifying incorrect operation 25
10.1 Not working 25
10.2 No spray 25

10.3 The power is not as expected 25
10.4 Ultrasounds not working 26
10.5 Water leakage 26
11 Technical specifications of the medical device 27
11.1 Identification 27
11.2 Generator 27
11.3 Length of cords 27
11.4 Irrigation 27
11.5 Footswitch 27
11.6 Environmental characteristics 27
11.7 Environmental restrictions 28
11.8 Main performance characteristics 28
12 Regulations and standards 29
12.1 Applicable standards and regulations 29
12.2 Medical class of the device 29
12.3 Symbols 29
12.4 Manufacturer identification 32
12.5 Branch addresses 33
12.6 Disposal and recycling 34
13 Index 36

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
General instructions relating to the complete range of dental ultrasonic generators J00011
Cleaning, disinfection and sterilisation instructions for wrenches J81001
Cleaning, disinfection and sterilisation instructions for tips J02001
Cleaning, disinfection and sterilisation instructions for handpieces J12911
Ultrasonic generator power settings table J58000
Consulting electronic user instructions J00007
Newtron®P5 User Manual J61101
Quick Clean Newtron®P5 J61001
Quick Start Newtron®P5 J61000
SLIM handpiece user manual J12921
Air and water filter and cartridge replacement and installation instructions J11330
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.
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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 used with a dental ultrasonic handpiece to which an ultrasonic instrument is attached. It is
designed for the treatment of prophylaxis,periodontics, endodontics and preservation and restoration dentistry.
2.2 Operating principle
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.
Mechanical vibrations are transmitted to a tip or a dental file attached to the end of the ultrasonic handpiece.
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.
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2.6 Warranty
The screws marked A, B, C, D and E must not be unscrewed by the user under any circumstances as this may void the
warranty for the medical device.
2.7 Latest document update
09/2017
2.8 Date of first CE marking
2013
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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 Newtron®P5 B.LED includes the following items:
lA Newtron®P5 B.LED unit with non-detachable footswitch cord, a non-detachable handpiece cord, a SLIM
handpiece support
lA disconnectable water supply pipe
lA Newtron SLIM handpiece, with, depending on configuration, an installed blue LEDring, a white LED ring
lA box containing disclosing liquid F.L.A.G.™ (depending on selected options)
lA LED handpiece Quick Start-Clean guide [J12930]
lA Newtron®P5 B.LED [J61000]Quick Start guide
lA Newtron®P5 B.LED [J61001] Quick Clean guide
lAn attachment kit
lTips and wrenches depending on selected options
lA power cord
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4 Connect the medical device
4.1 Connecting the medical device to the water system
Ask an approved dental installation technician to connect your medical device to the water system.
The water supply system pressure may vary throughout the day. The water supply system pressure must be adapted
to the values recommended for your medical device. It is very important to make sure that the maximum pressure
permitted for the medical device is never reached or exceeded. If in doubt, you are strongly advised to install or
arrange for installation of a water pressure limiting system.
Before a long period of absence or when the medical device is not in use for a long period of time, turn off the water
supply to the device or dental practice.
4.2 Connecting the medical device to the water system
The supply pipe connector is used to connect the medical device to the domestic water distribution system. The
connector is extended by a pipe to which you must attach a filter.The filter needs to be cleaned and replaced regularly
as specified in the chapter Clean the water filter cartridge. page 21.
The water supply must comply with the quality criteria compatible with the practice of dental treatments.
4.3 Installing a water filter
Water supplied by the system in place may not be of a quality suitable for dental treatments.In this case, you must
install a water filter on the medical device's water supply pipe.
Procure the relevant kit and the installation and maintenance instructions for water and air filters and cartridges
[J11330].
SATELEC, a company of Acteon group accepts no responsibility for damage caused by an installation provided
by a service provider that has not been approved by us.
4.4 Connecting the medical device to the electrical network
Have your medical device connected to the mains power by an approved dental installation technician.
Check that the mains voltage is compatible with that indicated on the medical device or its mains adapter.
A different voltage would cause damage to the medical device and could injure the patient and the user. Any variation
in the electrical network voltage or electromagnetic field that is non-compliant with the limits in force, could interfere
with the medical device's operation.
Medical devices equipped with a protective earth must be connected to a supply network equipped with a protective
earth.
Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or cable
tray.
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4.5 Connecting the medical device to the electrical network
1. Set the medical device's mains switch to "O" OFF position.
2. Connect the mains cord to the control unit's mains connector.
3. Connect the power lead to the mains socket.
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5 Installing the medical device
Place the medical device in the position that is suitable for your activity.
The medical device must be placed on a secure and flat surface or a surface with a maximum slope of five degrees.
Check that the cords do not hinder the movement or free circulation of anyone.
Adjust the position of your medical device to correspond to your angle of vision and the characteristics of your
workstation, e.g. lighting or distance between the user and the medical device.
Ensure that your medical device is readily accessible. The disconnecting devices - the switch and the power plug - must
be easy to access.
Do not install your medical device near or on another device.
5.1 Fixing the medical device to a non-removable support
After its initial installation, the medical device is not designed to be moved. The medical device must be fixed to ensure
that it cannot be removed or moved without the use of a tool.
5.2 Install cords
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.
5.3 Installing the control pedal
The control pedal must be positioned near the feet of the operator and must be readily accessible.
5.4 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.
Connect the handpiece to the socket by aligning the indexing points, without rotating it.
5.5 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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6 Dispensing a treatment
6.1 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.
6.2 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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7 Medical device description
7.1 Control unit
The control unit incorporates Newtron®technology patented by SATELEC, a company of Acteon group .
Newtron®technology emits ultrasonic vibrations in a controlled way.Relayed by SATELEC, a company of Acteon group
tips, these vibrations are used to deliver effective treatments and to ensure patient safety.
The control unit incorporates an dental ultrasonic generator equipped with a piezoelectric command.
7.2 Light indicator
The light indicator is designed to provide information about the status of the medical device.
When the light indicator is illuminated, the medical device is on and ready to use.
Each colour corresponds to the power level range.
7.3 Handpiece
There is a handpiece with SLIM B.LED to white LED connector and a handpiece with SLIM B.LED to blue LED connector.
Refer to the Newtron handpiece user manual [J12921] for more information.
The handpieces are designed to operate exclusively with SATELEC dental ultrasonic generators.
7.3.1 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.
7.3.2 Handpiece support
The support holds the handpiece or the cord sleeve.
The handpiece support can be fixed to the front face or the right side face of the medical device. To change the position
of this support, unscrew the two screws located under the support, position the support over the two holes located on
the right side face and insert and tighten the two fastening screws.
The silicone supports can be removed by sliding them along the metal rod. They can be sterilised.
7.4 Adjusts the power
The ultrasound power must be adjusted in accordance with the tip used and the required treatment. The operating
power of the tips must be selected in compliance with the Acteon tips color coding system (CCS tips).
Each tip must be used in accordance with the settings defined in the ultrasonic generator irrigation and power settings
table [J58000].
The ultrasound power configuration button is used to set the operating power: 1 to 20.
Rotating the button causes the colour of the medical device's backlighting to change.
lGreen: 1 to 6: very low to low power, used mainly for periodontics.
lYellow: 6 to 11: medium power, used mainly for endodontics.
lBlue: 11 to 16: high power, used mainly for scaling and preservation and restoration dentistry.
lOrange: 16 to 20: very high power, used mainly for loosening.
The ultrasound power configuration button can be removed by the user to facilitate the cleaning and disinfection of the
control unit. The button cannot be sterilised.
7.5 Setting the irrigation flow
The medical device must be set to minimum power to adjust the irrigation flow rate. Press the footswitch until a spray
appears.
Because work habits, feedback and professional training differ from one professional to another, the user must ensure
that the irrigation flow is compatible with the procedure to be carried out to prevent burns to the clinical site.
Adjust the irrigation flow using the irrigation flow configuration button. The flow rate must be adapted to the tip used
and to the required treatment.
Tighten to decrease the flow rate and loosen to increase the flow rate.
The irrigation flow configuration button is not designed to be removed.
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To avoid losing any device components, do not loosen the configuration button fully so that it comes off.
Each tip must be used in accordance with the settings defined in the ultrasonic generator irrigation and power settings
table [J58000].
7.6 Air inlets
Air inlets ensure correct ventilation of the control unit. Leave them uncovered to allow air to circulate.
7.7 Control pedal
The ON/OFF type control pedal is used by the practitioner to operate the medical device.
Pressing the footswitch automatically activates the handpiece ultrasounds, and the irrigation function if it is not
deactivated.
The footswitch equipped with its cord cannot be disconnected. Its weight and antislip pad ensure good stability.
The light function remains active for approx. 9 seconds after the pedal is released.
7.8 Mains Connector
The mains connector with its earthing pin is used to connect the device to the electrical network via a disconnectable
mains cord.
7.9 Switch
The mains switch is used to switch on (position I) or to stop (position O) the medical device.
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