Acteon Mini LED User manual

User Manual
Mini LED™

This document is an English translation of the original French version.
Reference J02540 version V8 and drawing number NG13FR010H

Contents
1 Documentation 5
1.1 Associated documentation 5
1.2 Electronic documentation 5
2 Required information 7
2.1 Indication for use 7
2.2 Operating principle 7
2.3 Using accessories not supplied by the manufacturer 7
2.4 Connecting and disconnecting accessories during use 7
2.5 Repairing or modifying the medical device 7
2.6 Warranty 7
2.7 Latest document update 7
2.8 Date of first CE marking 7
3 Unpacking the medical device 9
3.1 Precautions for use 9
4 Installing the medical device 11
4.1 Fixing the medical device to a non-removable support 11
5 Connect the medical device 13
5.1 Connecting the medical device to the electrical network 13
5.2 Mains adapter 13
5.3 Charge the battery 13
6 Dispensing a treatment 15
6.1 Accessory usage conditions 15
6.2 First use 15
6.3 Connect the accessories. 16
6.4 Using the medical device 16
6.5 Switching off the medical device 16
6.6 Disconnecting the medical device 16
7 Medical device description 17
7.1 Light indicator 17
7.2 Mini LED™ 17
7.3 Base 17
7.4 Operating mode 17
7.5 Buttons 18
7.6 Wave peak 18
7.7 Wave form 19
7.8 Cure depth 19
7.9 Mains adapter 19
8 Disinfection and sterilising 21
8.1 Clean and disinfect the medical device 21
8.2 Cleaning, disinfecting and sterilising accessories 21
9 Monitoring and routine maintenance 23
9.1 Check the power 23
10 Identifying incorrect operation 25
10.1 Not working 25
10.2 Charging base not working 25
10.3 Optical Guide 25
10.4 The power is not as expected 25
10.5 Malfunction of the power tester 26
10.6 Other malfunctions 26
11 Technical specifications of the medical device 27
11.1 Identification 27

11.2 Mains Adapter 27
11.3 Optical Guide 27
11.4 Handpiece 27
11.5 Battery 27
11.6 Base 28
11.7 Environmental characteristics 28
11.8 Environmental restrictions 28
11.9 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 31
12.5 Manufacturer responsibility 31
12.6 Branch addresses 32
12.7 Disposal and recycling 33
13 Index 35
14 Glossary 37

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 Mini LEDs 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 Mini
LED 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

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
Cleaning, disinfection and sterilisation instructions for the Mini LED optical guide J02941
Cleaning and disinfection instructions for the Mini LED rigid protection shield J05541
General instructions relating to the complete range of table curing lamps J02921
Consulting electronic user instructions J00000
Mini LED™ User Manual J02541
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.
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 designed to cure photosensitive composites and bonding composites used in dentistry. The
target clinical uses relate to conservative and restorative dentistry.
This medical device is used with an optical guide and a rigid protection shield.
2.2 Operating principle
Designed to light-cure dental composites, the Mini LED is fitted with electroluminescent diodes (LED) that emit a visible
blue light in a spectrum of wavelengths between 440 nm - 460 nm.
The wavelength of the light source corresponds to that of the photo-initiators used in dental curing composites.
A removable optical guide is attached to the end of the medical device. The optical guide concentrates and directs the
light produced to the clinical site.
2.3 Using accessories not supplied by the manufacturer
The Mini LED is designed to be used with SATELEC, a company of Acteon Group accessories. The use of optical guides,
protection shields or mains adapters made by other manufacturers will damage the Mini LED.
2.4 Connecting and disconnecting accessories during use
Never release the battery when the Mini LED is in use. When handling the mains adapter and the battery
disconnected from the handpiece, avoid all contact between these parts and the patient or any other party.
Do not disconnect the optical guide or the rigid protection shield when using your Mini LED.
2.5 Repairing or modifying the medical device
Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous
for you and your patients.
Do not repair or modify the device without seeking the prior permission of SATELEC, a company of Acteon Group.
If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical device is
still safe to use.
In the event of doubt, contact an approved dealer or the SATELEC, a company of Acteon Group Customer Service team:
www.acteongroup.com
[email protected]
SATELEC, a company of Acteon Group, at the request of technical personnel working for the network of
approved dealers, will provide any information required to repair defective parts on which they may perform
repairs.
2.6 Warranty
The user must not disassemble the base, the battery or the handpiece as this will void the medical device's warranty.
2.7 Latest document update
01/2017
2.8 Date of first CE marking
2007
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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 Mini LED™ includes the following items:
la 7.5mm-diameter multi-fibre optical guide with its ferrule
ldepending on the option, a 7.5mm-diameter, amber-coloured multi-fibre optical guide with its ferrule
la handpiece Mini LED
ltwo protection plugs for the handpiece
la charging base with an integrated power tester
la Lithium-ion battery
la rigid protection shield
la mains adapter
3.1 Precautions for use
Never point the medical device directly at the eyes even when it is not in use.
The Mini LED is powered by a built-in battery. Take the following precautions to protect your own safety:
lDo not remove, open or tear any parts of the Mini LED.
lDo not expose the Mini LED to sunlight, heat or fire.
lNever short-circuit your Mini LED.
lDo not store your Mini LED in a box or a drawer, where it could be short-circuited by other metal objects.
lIf the battery of the Mini LED leaks, avoid contact between the fluid and the skin or eyes. In the event of contact,
rinse thoroughly and refer to a doctor.
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lRegularly wipe the power supply connector with a soft and dry cloth.
lAfter lengthy storage, charge and discharge the Mini LED several times in order to achieve maximum
performance.
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4 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 locate and access.
Do not install your medical device near or on another device.
4.1 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.
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5 Connect the medical device
5.1 Connecting the medical device to the electrical network
Have your medical device connected to the mains power by an approved dental installation technician.
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.
5.2 Mains adapter
The medical device is designed to be connected to a separate power source that is considered to be an integral part of
the medical device. The device's power supply plug serves as the disconnect device. The electrical socket must be
installed near the device and must be readily accessible.
Do not touch the accessible charging base and battery connections.
The mains adapter and its cord are only designed to charge the Mini LED.
Check that the cord does not hinder the movement or free circulation of anyone whilst the Mini LED is charging. Make
sure that it is not possible to wheel over or walk on the cord. Plug the mains adapter plug into the Mini LED.
5.3 Charge the battery
The Mini LED operates with a Lithium-Ion battery. To guarantee optimum use, this battery must be fully charged before
use but must never be flat.
Check the contact between the charging base connectors and the battery connectors.
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6 Dispensing a treatment
6.1 Accessory usage conditions
The optical guide must be cleaned and sterilised prior to use. The rigid protection shield must be cleaned and
disinfected prior to use.
The Mini LED accessories include:
la charging base;
lan optical guide;
la rigid protection shield.
Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated
documentation page 5.
6.2 First use
To prepare your Mini LED, follow the steps below:
lClean and disinfect the rigid protection shield with an alcohol wipe.
lClean and disinfect the handpiece with an alcohol wipe.
lPlug the charging base into the mains.
lCheck that the green indicator light on the base lights up twice and listen out for a beep sound.
lInstall the battery on the handpiece.
lPlace the Mini LED on its charging base.
lThe Mini LED is correctly installed when two beeps are heard and the green indicator light on the base starts
flashing.
lLeave the Mini LED to fully charge.
lThe Mini LED is charged when the green indicator light on the base stops flashing and remains on permanently.
lRemove the protection plug from the handpiece nosepiece.
lInsert the sterilised optical guide into the handpiece nosepiece.
lYou will hear a click when the optical guide is correctly inserted.
lInstall the rigid protection shield.
lWear safety goggles and protective gloves.
lProvide your patient with safety goggles.
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6.3 Connect the accessories.
You will hear a click when the optical guide is correctly inserted.
6.4 Using the medical device
The Mini LED is normally placed on its base. To use it, remove it from its base.
Prior to the day of use, check that you have enough sterilised optical guides and check the power output as indicated in
the chapter page 23.
The patient and the practitioner must wear class II safety goggles when the Mini LED is in operation.
lRemove the Mini LED from the base;
lPress the on/off button.
lInstall the rigid protection shield;
lProgramme the Mini LED to select the required mode.
lPosition the end of the optical guide as close as possible to the surface of the material to be cured;
Do not allow the optical guide to touch the material to be cured.
lPress the on/off button to trigger the selected mode. A beep sound confirms cycle initiation;
lA second beep sound confirms cycle completion.
You can stop the cure cycle at any time by pressing the on/off button.
After three minutes of inactivity, the Mini LED switches to standby.
Depending on the cure material used, repeat the cure cycle as required.
6.5 Switching off the medical device
Press the ON/OFF button to stop a cure cycle.
The Mini LED switches off after three minutes of inactivity. Press the button to restart.
6.6 Disconnecting the medical device
Before a long absence or when not in use, the medical device must be cleaned, its battery must be removed and the
charging base must be disconnected from the mains power.
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7 Medical device description
7.1 Light indicator
The light indicators are designed to signal the device's status.
The handpiece has four light indicators in total.
Colour Mode
Green Normal mode
Red The battery is flat
Flashing red Thermal cut-out activated
On/off light indicator
Indicator Pictogram Colour Mode
High Green Fast
Medium Green Pulsed
Low Green Progressive
Three operating mode light indicators
The charging base has two light indicators.
Colour Meaning
Flashing green - upper indicator Charging
Green - upper indicator Charge fully completed
Red - lower indicator Power measured at less than 605 mW/cm2and insufficient for required operation
Off - lower indicator Power measured is insufficient for required operation
Green - lower indicator Power measured equal to or greater than 785 mW/cm2
Charging base light indicators
7.2 Mini LED™
The Mini LED can only be used with the following accessories:
l7.5mm opalescent optical guide
l7.5mm amber optical guide
lMini LED titanium battery
lMini LED handpiece
lProtection plug
lRigid protection shield
lCharging base and mains adapter
The protection plug is designed to prevent any products from infiltrating the handpiece that may damage its
electronics, the connector or the LEDs. It must be used when cleaning the handpiece. Another plastic protective plug
protects the connectors with the battery.
7.3 Base
The Mini LED charging base comprises a power tester. This is used to test correct operation of the Mini LED.
7.4 Operating mode
Rapid mode activates maximum power of the Mini LED for ten seconds.
Pulsed mode activates maximum power of the Mini LED in ten successive bursts lasting one second, each separated by
250 ms.
Progressive mode initiates a gradual rise in power lasting ten seconds followed by ten seconds at full power.
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7.5 Buttons
The Mini LED has two buttons.
located near the optical guide used to switch the Mini LED on and off.
used to select the required operating mode.
7.6 Wave peak
The waveform and its peak are identical in all three operating modes.
Opalescent optical guide Amber-coloured optical
guide
Wave peak 447.5 nm 447.5 nm
Maximum irradiance at 2 mm 1900 mW / cm21300 mW / cm2
Mean spectral irradiance in relation to the nominal value and
over time 1,250 mW / cm2925 mW / cm2
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