Acteon Endo Dual User manual

User Manual
Endo Dual

This document is an English translation of the original French version.
Reference J28940 version V1 and drawing number NO69FR080H
IEC 60601-1
EN ISO 13485
This equipment is designed and developed
in compliance with Electrical Safety
standard IEC 60601-1 in force. It was
designed and manufactured in accordance
with an EN ISO 13485-certied quality
assurance system.

1 -INTRODUCTION......................................................................................................................................5
2 -WARNINGS ..............................................................................................................................................5
3 -USE ...........................................................................................................................................................6
4 -DESCRIPTION ..........................................................................................................................................7
4.1 PHYSICAL DESCRIPTION.....................................................................................................................................................7
4.2 TECHNICAL DESCRIPTION ..................................................................................................................................................8
5 -INSTALLATION / COMMISSIONING................................................................................................... 10
5.1 REMOVING THE MEDICAL DEVICE FROM ITS PACKAGING...........................................................................................10
5.2 RECOMMENDATIONS........................................................................................................................................................10
5.3 INSTALLATION....................................................................................................................................................................10
6 -SETTINGS / PARAMETERS / INTERFACE............................................................................................. 10
6.1 START-UP ............................................................................................................................................................................10
6.2 PARAMETERS......................................................................................................................................................................10
6.3 TORQUE CALIBRATION .....................................................................................................................................................10
6.4 SETTING PROGRAM PARAMETERS...................................................................................................................................11
7 -USE OF THE MEDICAL DEVICE............................................................................................................ 13
8 -STOPPING THE MEDICAL DEVICE ...................................................................................................... 14
9 -MAINTENANCE AND STERILIZATION ................................................................................................ 14
9.1 MAINTENANCE OF THE CONTRA-ANGLE........................................................................................................................14
9.2 MAINTENANCE OF ROTATING INSTRUMENTS ..............................................................................................................14
9.3 MAINTENANCE OF THE MEDICAL DEVICE ......................................................................................................................14
9.4 MAINTENANCE OF THE ENDODONTIC MOTOR AND CORD.........................................................................................15
10 -PREVENTIVE AND CORRECTIVE MONITORING / MAINTENANCE................................................. 15
10.1 MONITORING.....................................................................................................................................................................15
10.2 PREVENTIVE AND CORRECTIVE MAINTENANCE.............................................................................................................15
10.3 OPERATING ANOMALIES ..................................................................................................................................................16
11 -ELECTROMAGNETIC COMPATIBILITY.............................................................................................. 17
11.1 CABLE LENGTH...................................................................................................................................................................18
11.2 RECOMMENDED SEPARATION DISTANCES.....................................................................................................................18
11.3 ELECTROMAGNETIC EMISSIONS......................................................................................................................................18
11.4 MAGNETIC AND ELECTROMAGNETIC IMMUNITY..........................................................................................................19
11.5 ELECTROMAGNETIC IMMUNITY, HANDHELD RADIOFREQUENCY EQUIPMENT........................................................19
12 -DISPOSAL AND RECYCLING.............................................................................................................. 20
13 -MANUFACTURER RESPONSIBILITY.................................................................................................. 20
14 -RULES AND REGULATIONS............................................................................................................... 20
15 -SYMBOLS ............................................................................................................................................ 20
16 -MANUFACTURER IDENTIFICATION.................................................................................................. 22
17 -BRANCH ADDRESSES......................................................................................................................... 22
Contents

User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
1 - INTRODUCTION
The Endo Dual Acteon endodontic motor incorporates the forward-reverse rotation and reciprocation system, compatible
with Satelec les. The classic rotation movement is also available.
The endodontic motor is a medical device that provides a high-precision angular measurement thanks to the ENCODER,
which precisely determines the angular positions.
In order to fully and sustainably benet from the performance of this medical device, it is imperative to have read
and understood the contents of the instructions for use relating to the use of your device and its accessories.
Never use your device without rst reading the user instructions.
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.
Indication for use
Endodontic motor (medical device)
The medical device is used in conjunction with an endodontic motor to which is attached a rotary instrument holder
equipped with a tool (le).
The medical device is intended for endodontic treatments performed by a dental practice.
2 - WARNINGS
The United States Federal Law restricts the use of this medical device to qualied, t and certied dental health
professionals (either directly or under their supervision).
To reduce the risks of accidents, the precautions detailed below must be respected:
2.0.1 USERS OF THE MEDICAL DEVICE
The use of the Endo Dual Acteon endodontic motor is limited to qualied, qualied, t and certied dental health
professionals in the normal course of their activities.
If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected.
User population:
Users must know and comply with the rules of dental practice in compliance with knowledge acquired in the eld and the
key medical hygiene principles including the cleaning, disinfection and sterilisation of medical devices.
The medical device can be used by any adult dental practitioner of any weight, age, height, gender or nationality.
-The user must wear gloves.
-The user is not the patient.
-The user must not be prone to any of the following:
-visual impairments: any vision problems must be corrected by glasses or lenses.
-arm disability that may prevent the user from holding a handpiece;
-leg disability that may prevent use of a footswitch;
-hearing diculties that could prevent the user hearing audible alarms depending on medical devices;
-diculty memorizing or concentrating that could affect the setting of sequences or the performance of treatment
protocols.
 No specic training other than initial professional training is required to use this medical device.
Patient population:
This medical device must not be used on the following patient populations:
-infants,
-pregnant or breastfeeding women due to restrictions associated with the possible use of medical solutions such as
anaesthetics;
-patients with medical issues,
-patients with a clinical site not suitable for treatment,
-Patients who wear an implantable medical device such as a pacemaker, cochlear implants, vagus nerve stimulators.
This medical device is designed to be used with the following patient population: children, teenagers, adults, seniors.
This medical device can be used on any patient of any weight (except children), age, height, gender or nationality.
The patient must be calm, relaxed, still, and ideally lying on a dental chair.
Parts of the body or types of tissues treated: Treatment must only be performed on the patient's oral environment.

User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
 An electrical signal emitted by the medical device is supplied to the
endodontic motor. It is connected to the medical device via a cord. It consists of a rotor and stator that transform the
electrical signal and mechanical rotations. The mechanical rotations are transmitted to a rotary instrument attached to the
end of a contra-angle.
Main performance characteristics:
Acteon Endo Dual Endon endodontic motor
Speed:
10,000 rpm max (with a contra-angle 1:1)
600 rpm max (with a contra-angle 16:1)
Torque: 10 Ncm (with a contra-angle 16:1)
Parts in direct contact with the patient: File, contra-angle, rotary instrument
3 - USE
The medical device must not be used above an altitude of 2000 meters. The medical device is not restricted to a number of
uses.
3.0.1 INTERACTIONS
The medical device complies with the electromagnetic compatibility standards in force. Practitioners must ensure that
any electromagnetic interference does not create an additional risk (presence of radio frequency transmitters, electronic
devices, etc.).
Interference can occur when used on patients with pacemakers. This system emits electromagnetic elds that present
potential risks. Malfunctioning of implantable devices, such as pacemakers and ICDs (implantable cardioverter
debrillators), is possible:
Before using this product, check whether patients and practitioners are tted with a device of this type; Explain the reason
for your question.
Determine the risk/benet ratio 

Keep this product away from implanted devices
Take the necessary emergency measures and immediate action if the patient becomes ill
Symptoms such as increased heart rate, irregular heartbeat, and dizziness may indicate incompatibility with a pacemaker
or ICD.
3.0.2 ELECTRICAL CONNECTION
Have your medical device connected to the mains power by an approved dental installation technician.
The device's electrical connection must be compliant with the standards in force in your country.
3.0.3 USE OF THE MEDICAL DEVICE
Do not use the medical device if it appears damaged or defective.
Before unplugging the power cord, turn off the medical device.
To disconnect the mains lead, grasp the mains lead plug while holding the wall socket.
When not in use for a long time, disconnect the medical device from the mains power supply.
Do not move the medical device during use.
Do not insert an object inside the endodontic motor
The MOTOR is delivered non-sterile
Use only the power adapter supplied.
Use only for the purpose for which it is intended. Failure to follow operating instructions can result in serious injury to
the patient or practitioner. Before using this medical device, make sure that you have read and understood the operating
instructions.
Connect the power cord to a suitable outlet.
Never touch the les when rotating.
3.0.4 ENVIRONMENT
-Do not cover the medical device.
-Do not immerse or use outdoors.
-Do not tilt the medical device to an angle of more than 5°.
-Do not place the medical device near a source of heat.
-Ensure that the cords do not hinder the free movement of people.
-The medical device must be stored in the original packaging, in a suitable place, without risk to people.
-The medical device is not designed to operate in the presence of anaesthetic gases or other ammable gases.
-Do not expose the medical device to water spray or mist.

User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
-The medical device is not designed to operate near a source of ionising radiation.
-Do not insert metallic objects into the medical device to avoid any risk of electric shock, short circuit or the emission of
hazardous substances.
Maintenance:
Before and after each use, it is imperative to disinfect your medical device with products recommended by the
manufacturer.
Before each intervention, it is imperative to use cleaned and disinfected accessories.
Accessories:
The medical device only accepts accessories designed by the manufacturer, and only for the use for which they were
intended.
The use of accessories from another source could put you or your patients at risk.
Repair:
Do not carry out any repairs or modications of the medical device without prior authorization from the manufacturer.
In the event of an anomaly, contact the supplier of your medical device. Do not use any repairer that could make your
medical device unsafe for you and your patients.
The pre-programmed modes of the endodontic motor are programmed for Satelec les in rotation and reciprocation; and
Satelec les are suitable for working with these parameters.
When using drills, cutters or other endodontic accessories, follow the manufacturer's recommendations for maximum
speed, torque, angle or forward and reverse directions.
4 - DESCRIPTION
4.1 PHYSICAL DESCRIPTION
-Electronic control console with MOTOR mount
-Footswitch
-Power

User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
4.2 TECHNICAL DESCRIPTION
4.2.1 LCD SCREEN / KEYPAD
The endodontic motor is adjusted by moderately pressing the keys on the keypad.
-The "MODE" button allows the practitioner to switch from forward-reverse alternating motion to rotary motion with
ease. The on-screen display varies accordingly.
-The + and - buttons allow you to scroll through the programs (from 1 to 10).
-Calib. enables automatic calibration of the contra-angle and the endodontic motor.
-Ratio is used to set the reduction ratio of the contra-angle. (1:1 - 6:1 – 8:1 - 16:1 - 20: 1- 32:1).
-Rpm followed by +/- buttons: Used to dene the rotational speed of the endodontic motor (value expressed in
revolutions per minute).
-Rpm followed by +/- buttons: Used to dene the torque of the endodontic motor (value expressed in Ncm).
-FWD/REV: Used to dene the clockwise or counter-clockwise rotation of the device.
-AR MODE: Used to dene the type of reverse rotation to Stop STP, Auto Reverse AR or Special Auto Reverse SAR.
-FWD° followed by +/- buttons: used to select the forward rotation angle between 10 and 360°.
-REV° followed by the +/- buttons: used to select the reverse rotation angle between 10 and 360°.
-Footswitch connector.
-Endodontic motor connector.
The information necessary for the practitioner is displayed on the LCD screen.

User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
4.2.2 REAR PANEL OF THE CONTROL UNIT
-Mains switch
-Power connector
4.2.3 FOOTSWITCH
Activates the selected maximum speed or starts a forward-reverse motion.
4.2.4 TECHNICAL SPECIFICATIONS
Console / endodontic motor / pedal
Manufacturer SATELEC, a company of Acteon group
Dimensions
(W x H x D) 170 x 72 x 130 mm Protection Class II
Materials ASA Type B
Endodontic motor 10,000 rpm /
torque: 6.8 mNm DM Class IIa according to Rule 9 of Annex IX to Directive 93/42/EEC
Noise < 65 dBA Input voltage 9 VDC
Input current 2.5 A
Console IP20 Pedal IPX1
Power adapter
Manufacturer Bridge Power Corp Output voltage 9 VDC
Model MENB 1030A0974C01 Output current 3 A
Input voltage 100 – 240 VAC Class II
Input current 1A MAX
Do not use in the presence of ammable anaesthetics or oxygen.
Operating conditions: Temp +18°C/+40°C (+64°F/+140°F) RH < 80 %. Altitude limit: 2,000 meters (6,500 feet).
Shipping and storage requirements for the console: Temp +0°C/+50°C (+32°F/+122°F) RH < 10-100% non-condensing.
Shipping and storage conditions of the endodontic motor: Temp -20°C/+70°C (-4°F/+158°F) RH <10-100 % non-condensing
Lifetime of the medical device: in accordance with the recommended operating conditions: 5 years No claim under
warranty will be accepted if a defect should occur during or after this period due to the variability in the frequency of use,
and in sterilization and maintenance conditions.

User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
5 - INSTALLATION / COMMISSIONING
5.1 REMOVING THE MEDICAL DEVICE FROM ITS PACKAGING
When you receive your medical device, check for any damage that may have occurred during transportation.
Contact your supplier if necessary.
5.2 RECOMMENDATIONS
Have your medical device connected to the mains power by an approved dental installation technician. The electrical
connection of the endodontic motor must comply with the standards in force in your country.
5.3 INSTALLATION




-Remove the unit and its accessories from their original packaging and place them on a at surface. Do not install near
direct or indirect sources of heat.
-Check the contents of the housing referring to the section "4.1 PHYSICAL DESCRIPTION".
-Do not bend the motor cord to avoid damaging it.
-All accessories are provided non-sterile.
-The serial number on the rear panel of the unit must be identical to that on the shipping documents.
-Leave at least 150 mm of space around the housing to ensure proper cooling.
-Place the control housing on a stable horizontal surface with a slope not exceeding 5°.
-Check that the mains switch is in the O (off) position.
-Connect the power cord to the power socket of the medical device.
-Plug the socket in accordance with your country's standards into the transformer and connect to a power outlet.
-Insert the 2 grey silicone pads on the 2 metal supports.
-Connect the foot pedal to the pedal connector.
-Place the pedal so that it is easily accessible to the foot.
-Connect the endodontic motor and the cord to the connector.
-Place the motor on the support.
6 - SETTINGS / PARAMETERS / INTERFACE
6.1 START-UP
Before powering up the central module, check that the installation of ALL THE COMPONENTS has been nalized.
The rst time it is turned on, the medical device displays the message "Rotating Mode", as well as the values set by the
manufacturer.
Use the "MODE" button to change from the "Rotating" movement to the forward-reverse rotation movement ("F+R").
6.2 PARAMETERS
The endodontic motor memorizes the parameters of each program as soon as they are set by the user; they are kept in
memory even if the central unit is turned off. The following parameters can be set and stored in each program: speed,
torque, contra-angle reduction ratio, autoreverse type, angular values in forward and reverse rotation. To restore the


User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
6.3 TORQUE CALIBRATION
To calibrate the torque, press the  key on the front panel, motor on. This function checks the mechanical inertia
of the handpiece to compensate for this value. This operation takes a few seconds, during which the motor will rotate at
different speeds.
Calibration time: approx. 8 seconds. Do not perform any operations during calibration. Calibration should be performed
before each endodontic session, or when the contra-angle is replaced or lubricated.
The le must not be in use during calibration.
Calibration must be performed before each intervention.
Do not perform calibration if the endodontic motor is not inserted into the receptacle on the front panel of the console. If
you make a mistake, perform a system reset, as shown below.
6.4 SETTING PROGRAM PARAMETERS
6.4.1 CLASSIC ROTATION MOVEMENT
Each program has been congured by the manufacturer with identical information:
-Reduction ratio: 16:1
-Speed: 300 rpm
-Direction: FWD (Forward)
-Torque: 0.5 Ncm
-"Special Autoreverse" mode: ON
The rst line displays:
-The mode in use: "Reciprocating / Rotating"
-The program: from P1 to P10
The second line displays:
-The reduction ratio of the contra-angle (left)
The "Ratio" button followed by +/- buttons allows the practitioner to modify the reduction ratio of the contra-angle.
-The direction of rotation (right)
The "FWD/REV" button is used to switch between forward and reverse movement, the selection of the reverse movement
being indicated by the continuous transmission of a beep.
The third line displays:
-The speed currently set (left).
The "RPM" buttons followed by the +/- buttons change the speed.
-The type of autoreverse (on the right).
The "AR MODE" button is used to choose between 3 types of autoreverse (STOP, AR, SAR)
The fourth line displays:
-The dened torque value, expressed in Ncm
The "Ncm" button followed by the +/- buttons is used to modify the dened torque value.
6.4.2 PROGRAMMING THE CONSOLE
RATIO: adjusts the reduction ratio of the handpiece. The following table gives the different reduction ratios available:
1:1 6:1 8:1 16:1 20:1 32:1

User Manual | Endo Dual | J28940 | V1 | 06/2018 | NO69EN080H
SPEED +/-: Adjusts the rotational speed of the motor. See the table below:
Reduction ratio:
RPM
1:1 6:1 8:1 16:1 20:1 32:1
1000 150 125 100 100 100
1500 200 150 150 120 150
2000 250 200 200 150 175
2500 300 250 250 200 180
3000 350 300 300 250 200
3500 400 350 350 280 250
4000 450 400 400 300 280
4500 500 450 450 350 300
5000 550 500 500 400
5500 600 550 550 450
6000 650 600 600 500
6500 700 650
7000 750 700
7500 800 750
8000 850 800
8500 900 850
9000 950 900
9500 1000 950
10000 1100 1000
1200 1100
1300 1200
1400 1250
1500
1600
TORQUE +/-: Increases or decreases the torque values. The torque values are expressed in Ncm; they depend on the
reduction ratio of the contra-angle. See the table below (with a 16:1 contra-angle):
Ncm
0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 MAX
FWD/REV: switches from forward to reverse rotation of the motor (in reverse rotation, the console beeps).
AR MODE: is used to dene the type of autoreverse:

The motor stops without going into reverse.

When the le reaches the set torque value, the motor switches to reverse rotation until it stops. The next time it starts it will
be in forward rotation. Note: This function is only applicable if the torque is not set to the maximum value.

When the le reaches the set torque value, the motor switches to reverse rotation until the le has been released. The
motor then returns to forward rotation. Note: This function is only applicable if the torque is not set to the maximum value.


Always check the set values before using the medical device. Misuse can lead to personal injury.
6.4.3 
Each program has been congured by the manufacturer with identical information:
-Reduction ratio: 16:1
-RPM 250 rpm
-Angular value in forward rotation: 30°
-Angular value in reverse rotation: 150°
The rst line displays:
-The mode in use: "Reciprocating / Rotating"
-The program: from P1 to P10

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The second line displays:
-The reduction ratio of the contra-angle (left)
-The "Ratio" button followed by +/- buttons allows the practitioner to modify the reduction ratio of the contra-angle.
-The clockwise angle of rotation (right)
-The "FWD" button followed by the +/- buttons changes the angular value in forward rotation.
The third line displays:
-The speed currently set (left).
The "RPM" buttons followed by the +/- buttons change the speed.
-The anti-clockwise angle of rotation (right)
The "REV" button followed by the +/- buttons changes the angular value in forward rotation.
6.4.4 PROGRAMMING THE DEVICE
-RATIO: Adjusts the reduction ratio of the contra-angle. The following table gives the different reduction ratios
available:
1:1 6:1 8:1 16:1 20:1 32:1
-RPM +/-: Adjusts the rotational speed of the motor. See the table below:
Reduction ratio:
1:1 6:1 8:1 16:1 20:1 32:1
RPM
1000 150 125 100 100 100
1500 200 150 150 120 150
2000 250 200 200 150 175
2500 300 250 250 200 180
3000 350 300 300 250 200
3500 400 350 350 280 250
4000 450 400 400 300 280
4500 500 450 450 350 300
5000 550 500 500 400
5500 600 550 550 450
6000 650 600 600 500
6500 700 650
7000 750 700
7500 800 750
8000 850 800
8500 900 850
9000 950 900
RPM
9500 1000 950
10000 1100 1000
1200 1100
1300 1200
1400 1250
1500
1600
-FWD° +/-: sets the forward rotation angle between 10° and 360°, in increments of 5°.
-REV° +/-: sets the angular value in reverse rotation between 10° and 360°, in increments of 5°.

USE OF THE MEDICAL DEVICE
Before turning on the console, verify that the installation of ALL THE COMPONENTS has been completed.
-Do not connect/disconnect the endodontic motor cord when the medical device is switched ON and the footswitch is
pressed.
-Do not engage or disengage the tool on the contra-angle while the endodontic motor is rotating.
-All of the accessories used must be cleaned and disinfected beforehand.
-For your safety and that of your patient, the endodontic motor should not be used with other accessories than those
provided by the manufacturer.
-Before and after use, check all of the medical device and its accessories for any problems.
-If problems are found, do not use the device and replace any defective items.

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The implementation of the endodontic motor is realized as follows:
-Ensure that the medical device is properly connected and properly insulated.
 ENDODONTIC MOTOR CONNECTION
-Connect the motor into the base at the front of the console (Right - metallic).
-Connect the contra-angle to the motor and mount an instrument (le) on the contra-angle.
Mount the correct "E-Type - ISO 3964" contra-angle on the motor. The latter can be used with most endodontic contra-
angles on the market, without internal illumination.
Use only contra-angles compliant with ISO 3964.
Replace the contra-angle only when the motor is stopped.
Place the endodontic motor on its support.
 CONNECTING THE PEDAL
-Connect the pedal into the base at the front of the console (Left - White).
-Put the pedal on the oor.


cords and cables.
 POWERING THE MEDICAL DEVICE, ELECTRICAL CONNECTION
Check the voltage supplied by the mains network (voltage accepted: 100 VAC to 240 VAC).
Connect the power cord to the endodontic motor by inserting the female connector of the power supply into the male port
on the back of the medical device.
Plug the power supply into a power outlet.
8 - STOPPING THE MEDICAL DEVICE
At the end of the dental procedure, you must:
-Switch off the medical device (O).
-Remove the instrument attached to the contra-angle.
-Disconnect the contra-angle from the endodontic motor.
-Disconnect the endodontic motor cord from the console.
9 - MAINTENANCE AND STERILIZATION
The endodontic motor and its cord cannot be sterilized in an autoclave.
9.1 MAINTENANCE OF THE CONTRA-ANGLE
For the contra-angle, refer to the manufacturer's instructions.
9.2 MAINTENANCE OF ROTATING INSTRUMENTS
Please refer to the instruction manual of the manufacturer of your instruments (les).
9.3 MAINTENANCE OF THE MEDICAL DEVICE
Do not use an abrasive product to clean the medical device.
Do not use spray for cleaning or disinfecting the medical device.
The medical device, the endodontic motor and the foot pedal cannot be sterilized.

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Unplug the console from its power source before any cleaning or disinfecting operation. Do not expose it directly to liquids
or sprays. Never immerse the console or any of its components in a liquid solution.
The outer surface of the console can be cleaned with a damp cloth or disinfectant wipes. The unit is not waterproof. Do not
use ultrasonic or steam sterilizers.
The console and foot control should be systematically cleaned and disinfected after each operation using an alcohol
solution, disinfectant or dental disinfectant wipes.
The outside of the pedal can be cleaned with a soft cloth moistened with a mild detergent or disinfectant solution.
It is necessary to regularly monitor the endodontic motor to detect any problems.
9.4 MAINTENANCE OF THE ENDODONTIC MOTOR AND CORD
Do not attempt to sterilize or lubricate the endodontic motor.
Do not disassemble the motor or endodontic motor connector. Unplug the medical device from its power source before
any cleaning or disinfecting operation. Do not expose it directly to liquids or sprays. Never immerse the motor in a
liquid solution. The outer surface of the motor can be cleaned with a damp cloth or disinfectant wipes. Do not place the
endodontic motor in an ultrasonic cleaner. The motor mount can be cleaned with a damp cloth or disinfectant wipes.
The irrigation clips and silicone holders can be sterilized. Sterilize at 134° C for 18 minutes or at 132° C for 4 minutes,
according to the instructions of the autoclave manufacturer.
Always check the set values before using the medical device. Misuse can lead to personal injury.
When treating patients who may have an acute and serious infectious disease, follow the hygiene measures in the relevant
publications and reports. Whenever possible, use disposable products that are suitable for preventing the transmission of
dangerous pathogens. You will protect the user, the patient and all those present in your practice.
10 - PREVENTIVE AND CORRECTIVE MONITORING / MAINTENANCE
In the event of an anomaly, contact the supplier of your medical device. Do not use any repairer that could make your
medical device unsafe for you and your patients.
10.1 MONITORING
Regular monitoring of the medical device and its accessories is necessary to detect any insulation problems or damage.
Replace if and when necessary.
10.2 PREVENTIVE AND CORRECTIVE MAINTENANCE
Check / overhaul of the endodontic motor: the manufacturer recommends checking or overhauling the endodontic motor®
at least once a year.
The endodontic motor cord has a limited service life and should be considered as a consumable. The service life of the cord
depends mainly on the use and the treatment (handling, retreatment and frequency of use).
Handle the motor and pedal cord carefully when connecting or disconnecting the medical device to prevent damage.
Regularly inspect the cord of the endodontic motor for damage before use. In case of visible damage, contact your dealer
or distributor.
-Do not disassemble the motor or endodontic motor connector.
-Do not oil or lubricate the endodontic motor.
-Do not attach a contra-angle to the motor if it is in operation.
-Do not bend the motor cord excessively.
The motor is very sensitive to shocks. Do not hit the motor against a hard surface.
Failure to comply with the above instructions will void the warranty.
The average service life of this medical device under normal operating conditions and according to the instructions in this
operating manual is 5 years. In accordance with EN 62353, we recommend practitioners carry out a check every 2 years
from the rst use: leakage current to earth, in the housing and in the patient.
10.2.1 RUBBER O-RING OF THE ENDODONTIC MOTOR
If necessary, replace the rubber O-ring.
10.2.2 LUBRICATION
Do not oil or lubricate the endodontic motor.

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10.3 OPERATING ANOMALIES
Fault: The console does not power on
Possible cause Solution
The power supply is not
properly connected
Check that the power supply is properly connected to the electrical outlet and the connector
on the back of the housing.
The medical device was
not properly powered on Check the On/Off button on the back of the unit.
Incorrect voltage
Check that the voltage corresponds to the power supply. If this is not the case, try turning
off the power, then turning on the central unit, or connecting the medical device to another
working electrical outlet. If the housing does not power on, check the integrity of the fuse
inside.
Internal connections
disconnected
PCB anomaly.
Power outage
Immediately stop using the medical device and contact the Satelec Customer Service.
Fault: The console powers off and stops abruptly
Possible cause Solution
The power cord is
damaged
PCB damaged
Internal connections
disconnected
Check the internal connections of the electrical outlet and the absence of liquid in the
housing, then switch on the central unit again. If the medical device does not power on,
immediately stop using it and contact the Satelec Customer Service.
Fault: The pedal does not start the motor
Possible cause Solution
The motor cord is not well
connected
Check that the motor cord is plugged into the connector on the front right of the central unit;
if not, unplug it and then plug it in again.
The pedal cord is not
properly connected
Check that the motor cord is plugged into the connector on the front right of the central unit;
if not, unplug it and then plug it in again.
The male connector of the
motor is damaged Disconnect the motor and check that the male connector is not damaged, damp or wet.
The connector pins are
damaged
Disconnect the motor and the pedal cord; check that the metal pins of the male connector are
intact and have not broken or become stuck in the female connector of the housing.
Incorrect voltage
Check that the voltage corresponds to the power supply. If this is not the case, try turning
off the power, then turning on the central unit, or connecting the medical device to another
working electrical outlet.
Fault: The screen does not work properly
Possible cause Solution
Contra-angle damaged Check the integrity of the contra-angle.
Incorrect voltage
Check that the voltage corresponds to the power supply. If this is not the case, try turning
off the power, then turning on the central unit, or connecting the medical device to another
working electrical outlet.
Possible interference
Check that the central unit is not too close to another electrical device that can cause
interference. If this is the case, move the interfering electrical device away from the central
unit.
Internal connections
disconnected
Screen damaged
PCB damaged
If you cannot identify the cause of the malfunction, stop using the medical device
immediately and contact the Satelec Customer Service.
Fault: The keyboard does not work properly
Possible cause Solution
Damaged keyboard
Internal connections
disconnected
Contact Satelec Customer Service.

Possible cause Solution
Internal connections
disconnected Immediately stop using the medical device and contact the Satelec Customer Service.
Fault: The motor does not work
Possible cause Solution
The motor cord is not well
connected
Check that the motor cord is plugged into the connector on the front right of the central unit;
if not, unplug it and then plug it in again.

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Contra-angle defective or
incorrectly calibrated Check the integrity of the contra-angle. Remove the contra-angle and calibrate.
Incorrect voltage
Check that the voltage corresponds to the power supply. If this is not the case, try turning
off the power, then turning on the central unit, or connecting the medical device to another
working electrical outlet.
PCB damaged
Damaged motor
Connector pins and/or
cord damaged
Immediately stop using the medical device and contact the Satelec Customer Service.
Fault: Motor suddenly stops
Possible cause Solution
Motor / cord damaged Check that the motor cord is plugged into the connector on the front right of the central unit;
if not, unplug it and then plug it in again.
Incorrect voltage
Check that the voltage corresponds to the power supply. If this is not the case, try turning
off the power, then turning on the central unit, or connecting the medical device to another
working electrical outlet.
PCB damaged If you cannot identify the cause of the malfunction, stop using the medical device
immediately and contact the Satelec Customer Service.
Fault: The motor does not switch off
Possible cause Solution
Internal connections
disconnected Immediately stop using the medical device and contact the Satelec Customer Service.
PCB damaged Immediately stop using the medical device and contact the Satelec Customer Service.
Incorrect voltage
Check that the voltage corresponds to the power supply. If this is not the case, try turning
off the power, then turning on the central unit, or connecting the medical device to another
working electrical outlet.
11 - ELECTROMAGNETIC COMPATIBILITY
All the information below is based on the requirements of standards to which the manufacturers of
electrical medical devices must adhere (as stated in standard IEC 60601-1-2).
The medical device complies with the electromagnetic compatibility standards in force; however, the practitioner should
ensure that any electromagnetic interference does not create an additional risk, such as
radio frequency transmitters or other electronic devices.
This chapter contains the information necessary to allow you to install and
start using your device in the best possible conditions in terms of electromagnetic compatibility.
The different medical device cords must be kept away from each other.
Some types of mobile telecommunication devices such as mobile phones may interfere
with the medical device. The separation distances recommended in this chapter
MUST be complied with.
The medical device must not be used near another device or placed on top of it. If this cannot be
avoided, correct operation of the device in operating conditions must be checked prior to use.
The use of accessories other than those specied or sold by SATELEC, a company of Acteon group as
replacement parts, may result in an increase in the emission or a decrease in
the immunity of the medical device.

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11.1 CABLE LENGTH
Cables and accessories Maximum length Test type In compliance with:
Cables/Cords < 3 m
RF emissions CISPR 11, Class B
Harmonic current emission IEC 61000-3-2
Voltage uctuation and
ickers
IEC 61000-3-3
Electrostatic discharge
immunity
IEC 61000-4-2
Radiated immunity -
Electromagnetic elds
IEC 61000-4-3
Electrical fast transient/burst
immunity
IEC 61000-4-4
Surge immunity IEC 61000-4-5
Conducted immunity -
Disturbances induced by
radio-frequency elds
IEC 61000-4-6
Radiated immunity -
Magnetic elds
IEC 61000-4-8
- Voltage dips, short
interruptions and voltage
variation immunity
IEC 61000-4-11
11.2 RECOMMENDED SEPARATION DISTANCES
The medical device is designed to be used in an electromagnetic environment in which interferences caused by
radiofrequency radiation are controlled. The user or installer of the medical device may help to prevent electromagnetic
interference by maintaining a minimum distance, depending on the maximum power of the handheld and mobile
radiofrequency transmission equipment (transmitters), between the medical device and the equipment as recommended in
the table below.
Separation distance in metres (m) determined by transmitter frequency
Max. nominal power of the
transmitter in Watts
From 15 kHz to 80 kHz
d = 1.2
From 80 MHz to 800 MHz
d = 1.2
From 800 MHz to 2.5 GHz
d = 2.3
0.01 0.12 m 0.12 m 0.23 m
0.1 0.38 m 0.38 m 0.73 m
1 1.2 m 1.2 m 2.3 m
10 3.8 m 3.8 m 7.3 m
100 12 m 12 m 23 m
With regards to transmitters for which the maximum power is not listed above, the recommended separation distance (d)
in metres (m) can be estimated by using the equation applicable to the transmitter frequency where (P) is the maximum
power of the transmitter in watts (W) according to the manufacturer.
Note 1: At 80 MHz and 800 MHz, the highest frequency range applies.
Note 2: These specications may not be applicable in all situations.
The electromagnetic propagation is reduced by the absorption and reection of structures, objects and
people.

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11.3 ELECTROMAGNETIC EMISSIONS
The medical device is designed for use in the electromagnetic environment described in the table below.
The practitioner and/or installer must ensure that the medical device is used in the environment
described below.
Emission test Conformity Electromagnetic environment - comments
RF emission (CISPR 11) Group 1 The medical device uses radiofrequency energy for its internal
operation. Consequently, its radiofrequency emissions are very
low and are not likely to create any interference with other nearby
equipment.
RF emission (CISPR 11) Class B
The medical device is suitable for use in all establishments, including
domestic and those directly connected to the low voltage energy
supply public network supplying buildings used for domestic
purposes.
Harmonic current emission
(IEC 61000-3-2)
Class A
Voltage uctuation and
ickers (IEC 61000-3-3)
Compliant
11.4 MAGNETIC AND ELECTROMAGNETIC IMMUNITY
The medical device is designed for use in the magnetic and electromagnetic environment described in the
table below. The practitioner and/or installer must ensure the compliance of the
electromagnetic environment.
Immunity test Test level in
accordance with IEC
60601
Conformity level Electromagnetic environment - comments
Electrostatic
discharge (ESD) (IEC
61000-4-2)
± 6 kV on contact
± 8 kV in the air
± 6 kV on contact
± 8 kV in the air
Floors must be made of wood, concrete, cement or
tiled. If oors are covered with synthetic materials
(carpet, etc.), the relative humidity must be 30%
minimum.
Electrical fast
transients (IEC
61000-4-4)
± 2 kV for electricity
supply lines
± 1 kV for signal
ports
± 2 kV for electricity
supply lines
The quality of the electricity supply must be
equivalent to that of a typical commercial
environment or hospital establishment (hospital,
clinic).
Surges (IEC 61000-
4-5)
± 1 kV in differential
mode
± 2 kV in common
mode
± 1 kV in differential
mode
± 2 kV in common
mode
The quality of the power supply must be
equivalent to that of a typical
commercial or hospital environment.
Magnetic eld at 50
Hz/60 Hz (IEC 61000-
4-8)
3 A/m 3 A/m The magnetic eld intensity must be equal to the
level found in a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
(IEC 61000-4-11)
< 5% UT
(> 95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(>95% dip in UT)
for 250 cycles
< 5% UT
(> 95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(>95% dip in UT)
for 250 cycles
The quality of the network supply must be
equal to that of a typical commercial or hospital
environment. If the use of the system requires
continuous operation during mains power outages,
it is advisable to supply the medical device using a
separate current source (UPS, etc.).

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11.5 ELECTROMAGNETIC IMMUNITY, HANDHELD RADIOFREQUENCY EQUIPMENT
The medical device is designed for use in the magnetic and electromagnetic environment described in the table below. The
user and/or installer must ensure conformity of the electromagnetic environment. *
Immunity test Test level in accordance with
IEC 60601
Conformity level Electromagnetic
environment - comments
Handheld and mobile radiofrequency communication devices must not be used near the medical device (including cables)
at a distance below that recommended and calculated according to the frequency and power of the transmitter.
Radiated,
radio-frequency,
electromagnetic elds
(IEC61000-4-3)
3 V/m
80 MHz to 2.5 GHz
3 V/m d = 2.3 √ P 800 MHz to
2.5 GHz
Where (P) is the
maximum rated power
of the emitter in Watts (W)
according to the
specications of
manufacturer and (d) is the
minimum distance in
meters (m) of separation
recommended.
Immunity to conducted
disturbances
(IEC61000-4-6)
3 V/m
150KHz to 80MHz
3 V/m d = 1.2 √ P 80 MHz to
800 MHz
Separation distance
recommended: d = 1.2 √P
The intensity of electromagnetic elds of xed radiofrequency transmitters, as determined by an electromagnetic
environment measurement (a), must be less than the compliance level for each frequency range (b). Interference may
occur near equipment marked with the following symbol:
environment measurement (a), must be less than the compliance level for each frequency range (b). Interference may
Note 1: At 80 MHz and 800 MHz, the highest frequency range applies.
Note 2: These specications may not be applicable in all situations. Electromagnetic propagation
is affected by the absorption by and reection from structures, objects and people.
(a) The intensities of the electromagnetic elds of xed radio-frequency transmitters, such as base stations
for mobile phones (cellular / wireless), mobile radios, radio amateurs, AM/FM radio and
TV broadcasts cannot be determined accurately by theory.
To assess the electromagnetic environment caused by xed radiofrequency transmitters, an
electromagnetic environment measurement must be made. If the measured intensity of the radio-frequency eld in
the immediate environment of use of the product exceeds the level of radio-frequency compliance specied above,
it is necessary to test the products' performance characteristics to check that they comply with the specications. If
abnormal characteristics are observed, additional measures may be necessary, such as changing the direction or
moving the product.
(b) In the 150 kHz to 80 MHz frequency range, the electromagnetic elds must be less than 3 V/m.
12 - DISPOSAL AND RECYCLING
As an electrical and electronic equipment, the disposal of the medical device must be carried out according to a specialized
system of collection, removal and recycling or destruction (in particular on the European market, with reference to Directive
n° 2012/19/EU of July 2012.
When your medical device has reached the end of its life, we recommend that you contact your dental equipment dealer for
instructions on how to proceed.
13 - MANUFACTURER RESPONSIBILITY
The manufacturer shall under no circumstances be liable for:
-non-compliance with the manufacturer's recommendations during installation (mains voltage, electromagnetic
environment, etc.),
-intervention, modication or repair procedures carried out by persons not authorized by the manufacturer,
-use on an electrical xture that is not compliant with the regulations in force,
-uses other than those specied in this manual,
-use of accessories (motor and cord, pedal, etc.) other than those supplied by the manufacturer.
-non-compliance with the instructions contained in this document.
Note: The manufacturer reserves the right to modify the medical device and/or the user manual without prior notice.