Acteon Satelec Newtron P5XS B.LED User manual

User Manual
Newtron P5XS B.LED

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 Warranty 8
2.7 Accessory usage conditions 8
3 Removal from packaging, installation, connections 9
3.1 Unpacking your medical device 9
3.2 Positioning the medical device 9
3.3 Installing cords 9
3.4 Connecting the medical device to the electrical network 9
3.5 Plugging the medical device to the electrical network 10
3.6 Installing the control pedal 10
4 Description of the medical device 11
4.1 Control unit 11
4.2 Power configuration button 11
4.2.1 Remote configuration via Bluetooth (depending on option) 11
4.3 Adjusting ultrasound power 11
4.4 SLIM handpiece 11
4.5 Attach a tip or a file 11
4.6 Connecting and disconnecting accessories during use 12
4.7 Connecting the handpiece 12
4.8 Handpiece support 12
4.9 The cord 12
4.10 Light indicator 12
4.11 Irrigation flow configuration button 12
4.12 Adjusting the irrigation 12
4.13 Initiating irrigation 13
4.14 Air inlets 13
4.15 Control pedal 13
4.16 Activating ultrasounds using the pedal 13
4.17 Mains Connector 13
4.18 Switch 13
4.19 Fuse recess 13
4.20 Irrigation solution tank 13

4.21 Filling the tank 13
4.22 Pump 13
4.23 Cleaning the irrigation system 13
5 Cleaning, disinfecting and sterilizing 15
5.1 Cleaning and disinfection of the medical device 15
5.2 Cleaning and disinfecting accessories 16
5.3 Diamond coated tips 16
6 Monitoring and maintenance of the medical device 17
7 Maintenance 19
7.1 Identifying incorrect operation 19
7.1.1 No operation 19
7.1.2 No spray 19
7.1.3 The power is not as expected 19
7.1.4 Ultrasounds not working 20
7.1.5 Water leakage 20
7.2 Corrective Maintenance 20
7.2.1 Replacing the fuses 20
7.2.2 Replacing the irrigation cassette 21
8 Technical specifications for the medical device 25
8.1 Identification 25
8.2 Control unit 25
8.3 Ultrasonic generator 25
8.4 Length of cords 25
8.5 Irrigation 25
8.6 Control pedal 26
8.7 Environmental characteristics 26
8.8 Environmental restrictions 26
8.9 Main performance characteristics 26
9 Regulations and standards 27
9.1 Official Texts 27
9.2 Medical class of the device 27
9.3 Standardised Symbols 28
9.4 Manufacturer identification 29
9.5 Branch addresses 30
9.6 Disposal and recycling 32
10 Index 33

Foreword
The medical device SATELEC®that you are about to install and use in your practice is a
medical device designed for professional use. It comprises the chosen 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.
If you have received this medical device by mistake, please contact the supplier to arrange
for it to be collected.
Please refer to the general instructions relating to the comprehensive range of dental
ultrasonic generators by SATELEC®for information about the following:
ldocumentation format;
lthe documentation archiving period;
lwarnings concerning user population;
lthe treatment area;
lthe medical device usage interactions, contraindications and prohibitions;
lelectromagnetic compatibility;
ldisposal and recycling of the medical device;
lmanufacturer responsibility.
Please refer to the accessory cleaning, disinfection and sterilization protocols and the
handpiece predisinfection, cleaning and sterilisation protocols for information about the
following:
lpreparation of parts for sterilization;
ldetailed manual and automatic protocols;
linformation concerning the 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;
luse of the medical device;
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
Cleaning, disinfection and sterilization protocols for Wrenches SATELEC®J81009
Cleaning, disinfection and sterilization protocols for Tips SATELEC®J02009
Cleaning, disinfection and sterilization protocols for Handpieces SATELEC®J12919
General instructions relating to the complete range of SATELEC®dental ultrasonic generators J00019
Method for consulting electronic user instructions J00000
Quick Clean Newtron®P5XS B.LED J62101
Quick Start Newtron®P5XS B.LED J62100
User Manual for Newtron®P5XS B.LED J62159
Software User Manual Newtron®P5XS B.LED J62111
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
writing.
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
This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for
preservation and restoration dentistry, including prosthesis.
2.2 Operating principle
An electrical signal emitted by the medical device is supplied to the dental 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 Date of inclusion of EC marking
2013
2.4 Latest document update
11/2013
2.5 Repairing or modifying the device
Contact the supplier of your device. Using the services of an unapproved repairer could render your device
dangerous for you and your patients.
Do not repair or modify the medical device without seeking the prior permission of SATELEC®.
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®, provides all information required to repair the faulty parts on which they may perform
repairs.
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2.6 Warranty
The screws marked A, B and C must not under any circumstances be unscrewed by the user as this may void the
warranty for the medical device.
2.7 Accessory usage conditions
Accessories and must be cleaned, disinfected and sterilized prior to use.
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3 Removal from packaging,
installation, connections
3.1 Unpacking your 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®P5XS B.LED includes the following items:
la Newtron®P5XS B.LED unit with non-detachable pedal cord, a non-detachable SLIM cord, a 300 or
500ml tank and a SLIM handpiece support;
la Newtron®SLIM handpiece, a Quick Start [J12900]and a Quick Clean [J12930];
ltips and wrenches depending on selected options;
la Quick Start Newtron®P5XS B.LED [J62100];
la Quick Clean Newtron®P5XS B.LED [J62101].
3.2 Positioning the medical device
Place the control unit in the position that is suitable for your activity.
Check that the cords do not hinder the movement or free circulation of anyone.
The medical device must be placed on a secure and flat surface or a surface with a maximum slope of 5
degrees.
Fix your medical device using the attachments provided to ensure that the device cannot be removed without
the use of a tool.
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 you can access your medical device quickly.
Do not install your medical device near or on another device.
3.3 Installing cords
Check that the cords do not hinder the movement or free circulation of anyone.
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 must be easily accessible. Make sure that the cord is slack during use.
Do not put the medical device cords in a cable cover or a cable tray.
3.4 Connecting the medical device to the electrical network
Set the medical device to OFF position O and check that the mains voltage is compatible with that indicated on
the medical device or its mains adapter. Next, connect the cord to the wall socket in compliance with the
standards in force in the country of use.
A different voltage would cause damage to the medical device and could injure the patient and/or 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.
The medical devices equipped with a protective earth must be connected to a supply network equipped with a
protective earth.
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Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or
cable tray.
3.5 Plugging the medical device to the electrical network
1. Set the medical device's mains switch to stop position O;
2. connect the mains cord to the control unit mains connector;
3. connect the mains cord to the electrical fixture wall socket.
3.6 Installing the control pedal
The control pedal must be positioned near the feet of the operator and must be readily accessible.
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4 Description of the medical device
4.1 Control unit
The control unit incorporates technology Newtron®patented by SATELEC®.
The patented technology Newtron®controls the tips by Cruise Control®, an automatic system for setting the
frequency and power in real time. This ensures that Satelec® tip vibration is gentle, regular and controlled.
4.2 Power configuration button
To ensure a quality treatment, you will need to use the tips at the power and irrigation flow settings
recommended by SATELEC®.
The ultrasound power configuration button ensures:
lConfiguration of the operating power: 1 to 20.
The configuration button has 20 graduations.Rotating the button causes the color of the retro-lightning 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 scale removal.
lOrange: 16 to 20: very high power, used mainly for implant 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.
The removal of the button inhibits the activation of ultrasounds. The top surface of the control unit lights up
white and the control pedal can be pressed to activate the purge function. The purge function can be stopped
at any time by pressing the control pedal again.
4.2.1 Remote configuration via Bluetooth (depending on option)
The Newtron®P5XS B.LED, depending on the option, allows you to use a tablet or a smartphone to remotely
pre-configure the power and irrigation settings.
Refer to the P5XS application instructions [J62111] for more information.
Only the Newtron®P5XS B.LED with Bluetooth option is compatible with remote configuration.
4.3 Adjusting ultrasound power
Adjust the ultrasound power using the ultrasound power configuration button. 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 Satelec tips color coding system (CCS tips). Details of these indications are
given in the adjustment table available at the address www.satelec.com/documents and on the
treatment sheets.
4.4 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 LED. Refer to the
Newtron®handpiece user manual [J12921] for more information.
4.5 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.
Tighten 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 .
To prevent self-locking of the tip or the file, the latter must be removed after each use.
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4.6 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.
4.7 Connecting the handpiece
Check for the absence of signs of humidity at the connections, and eliminate them if necessary (wipe and blow
using a multipurpose syringe).
Lubricate the irrigation system seal located behind the with dental instrument lubricant such as
ClearView™ Dental Handpiece Lubricant manufactured by Dental Air Solutions to extend its
effectiveness and prevent leaks.
Connect the to the sleeve, by aligning the indexing points and by avoiding rotation movement.
Install the on the support.
4.8 Handpiece support
The support holds the handpiece or the handpiece connector.
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 two silicone supports can be removed by sliding them along the metal rod.
4.9 The 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 .
4.10 Light indicator
The light indicator is designed to provide information about the status of the device.
When the light indicator is illuminated, the medical device is on and ready to use. The indicator's colour
corresponds to the power level.
4.11 Irrigation flow configuration button
The irrigation flow configuration button stops the irrigation function at the minimum stop marked by "O" and
sets the irrigation flow from mark "I" to "+":
The irrigation flow configuration button can be removed to clean the medical device. The button cannot be
sterilised.
The purge function is activated by pressing the pedal for 4 minutes; it can be stopped by pressing the pedal
again.
The pump operates at its maximum flow rate in purge position.
4.12 Adjusting the irrigation
Adjust the irrigation flow using the irrigation flow configuration button. This adjustment depends on the tip and
the treatment.
As work habits, feedback and professional training differ from one professional to another, the user must make
sure that the irrigation flow is perfectly adapted to the treatment to be carried out to avoid burning the
treatment area.
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4.13 Initiating irrigation
The medical device must be set to minimum power depending on the required irrigation flow rate. Press the
pedal until a spray appears.
4.14 Air inlets
Air inlets ensure correct ventilation of the control unit. Leave them uncovered to allow air to circulate.
4.15 Control pedal
The ON/OFF type pedal is used by the practitioner to operate the medical device.
Pressing the pedal automatically activates the handpiece ultrasounds, and the irrigation function if it is not in 0
position.
The control pedal 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.
4.16 Activating ultrasounds using the pedal
To activate the ultrasounds on your medical device, press the control pedal.
4.17 Mains Connector
The mains connector with its earthing pin is used to connect the device to the electrical network via a
disconnectable mains cord.
4.18 Switch
The mains switch is used to switch on (position I) or to stop (position O) the medical device.
4.19 Fuse recess
The recess holds two mains fuses designed to protect the medical device in the event of overvoltage or an
internal fault.
4.20 Irrigation solution tank
The medical device is equipped with a tank designed to hold 300ml or 500ml of irrigation solution depending on
the option chosen. The maximum capacity is shown by the MAX mark on the tank.
The irrigation solution tank is fitted with a cover. Neither the tank nor the cover can be sterilised.
4.21 Filling the tank
Remove the tank from the medical device by pulling it upwards. Fill the irrigation solution tank up to the MAX
mark.
4.22 Pump
The medical device is fitted with a peristaltic pump. This pump must be replaced yearly by the practitioner
using the F62202 kit or by the After-Sales Department SATELEC®.
4.23 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.
1. fill the tank with hypochlorite diluted at less than 3%;
2. position the irrigation flow configuration button on purge;
3. operate the irrigation spray for two minutes to rinse the medical device's internal water system;
4. refill the tank with demineralised or distilled water, or even drinking water;
5. rinse the system for two minutes.
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When the irrigation system has been cleaned, perform the following operations:
1. disconnect the handpiece and refer to handpiece predisinfection, cleaning and sterilisation protocols
SATELEC®[J12919];
2. clean and disinfect the medical device as indicated in the chapter Cleaning and disinfection of the
medical device page 15
3. follow the instructions for accessory cleaning, disinfection and sterilization protocols SATELEC®
[J81009] and [J02009].
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5 Cleaning, disinfecting and
sterilizing
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 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 accessory cleaning, disinfection and sterilization
protocols take precedence over the information provided by SATELEC®.
5.1 Cleaning and disinfection of the medical device
The medical device must be in OFF or O stop position during cleaning and disinfecting procedures.
Refer to the instructions detailed in the chapter Cleaning the irrigation system page 13
Avoid using cleaning and disinfection products that contain flammable agents.
Otherwise, ensure that the product has completely evaporated from or that there is not fuel left on the medical
device and its accessories before switching it on.
Do not use 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 medical device control unit, handpiece cord and control pedal must be cleaned and disinfected daily.
The wipes Unowipes manufactured by Medicart International Ltd may be used to clean and sterilise the medical
device.
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To prepare for cleaning, remove the various parts of Newtron®P5XS B.LED as shown here.
5.2 Cleaning and disinfecting accessories
Refer to the accessory cleaning, disinfection and sterilization protocols listed in the chapter Associated
documentation page 5.
5.3 Diamond coated tips
Diamond coated tips are for single use only.
The diamond coated inserts cannot be reprocessed since they cannot be cleaned properly.Bone and soil
residues might remain adhered to the diamon coating even after cleaning and sterilization and enter into the
oral cavity of another patient.
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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
necessary to detect any isolation fault or damage. If necessary, replace damaged parts.
Monitor the cleanliness of the air inlets on the control unit to prevent any heating.
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