Acteon MINILED SUPERCHARGED User manual

User Manual
MINILEDSUPERCHARGED

This document is an English translation of the original French version.
Reference J02261FR version V2 and drawing number NG35FR010B

Contents
1 Documentation 3
1.1 Associated documentation 3
1.2 Electronic documentation 3
2 Required information 5
2.1 Indication for use 5
2.2 Operating principle 5
2.3 Using accessories not supplied by the manufacturer 5
2.4 Connecting and disconnecting accessories during use 5
2.5 Repairing or modifying the medical device 5
2.6 Warranty 5
2.7 Latest document update 5
2.8 Date of first CE marking 5
3 Unpacking the medical device 7
3.1 Precautions for use 7
4 Installing the medical device 9
4.1 Fixing the medical device to a non-removable support 9
5 Connect the medical device 11
5.1 Connecting the medical device to the electrical network 11
5.2 Mains adapter 11
5.3 Charge the battery 11
6 Dispensing a treatment 13
6.1 Accessory usage conditions 13
6.2 Preparation for use 13
6.3 Connect the accessories. 14
6.4 Using the medical device 14
6.4.1 Switching on the medical device 14
6.4.2 Configuring the medical device 14
6.4.2.1 Selection of the mode 14
6.4.2.2 Selecting the exposure time 14
6.4.3 Performing a cure cycle 15
6.5 Switching off the medical device 15
6.6 Disconnecting the medical device 15
7 Medical device description 17
7.1 Screen of the medical device 17
7.2 Light indicator 17
7.3 MINILED SUPERCHARGED 17
7.4 Base 17
7.5 Operating mode 17
7.6 Buttons 18
7.7 Wave peak 18
7.8 Waveform with micro-flash 18
7.9 Mains adapter 18
8 Disinfection and sterilising 19
8.1 Clean and disinfect the medical device 19
8.2 Cleaning, disinfecting and sterilising accessories 19
9 Monitoring and routine maintenance 21
9.1 Check the power 21
10 Identifying incorrect operation 23
10.1 Not working 23
10.2 Charging base not working 23
10.3 Optical Guide 23

10.4 The power is not as expected 23
10.5 Malfunction of the power tester 24
10.6 Other malfunctions 24
11 Technical specifications of the medical device 25
11.1 Identification 25
11.2 Mains Adapter 25
11.3 Optical Guide 25
11.4 Handpiece 25
11.5 Battery 26
11.6 Environmental characteristics 26
11.7 Environmental restrictions 26
11.8 Main performance characteristics 27
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 31
12.7 Disposal and recycling 33
13 Index 35
14 Glossary 37

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 MINILED optical guide J02941
Cleaning and disinfection instructions for the MINILED rigid protection shield J05541
General instructions relating to the complete range of table curing lamps J05102EN
Consulting electronic user instructions J00007
MINILED SUPERCHARGED User manual J02261EN
Cleaning and disinfection instructions for the MINILED flexible protection shield J05551
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 MINILED is fitted with an electroluminescent diode (LED) that emits a
visible blue light in a spectrum of wavelengths between 420 nm - 480 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 MINILED 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 MINILED.
2.4 Connecting and disconnecting accessories during use
Never release the battery when the MINILED 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 MINILED.
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
08/2018
2.8 Date of first CE marking
2009
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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 MINILED SUPERCHARGED includes the following items:
la 7.5mm-diameter, 45° curve, multi-fibre opalescent optical guide with its ferrule;
la MINILED SUPERCHARGEDhandpiece;
ltwo protection plugs for the handpiece;
la charging base with an integrated power tester
la Lithium-ion battery;
la mains adapter;
lAn insulating ring to be removed before first use. See Quick Start J02534
la MINILEDSUPERCHARGEDQuick Start;
la MINILED SUPERCHARGED Quick Clean;
la rigid protection shield (optional)
3.1 Precautions for use
Never point the medical device directly at the eyes even when it is not in use.
The MINILED 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 MINILED.
lDo not expose the MINILED to sunlight, heat or fire.
lNever short-circuit your MINILED.
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lDo not store your MINILED in a box or a drawer, where it could be short-circuited by other metal objects.
lIf the battery of the MINILED leaks, avoid contact between the fluid and the skin or eyes. In the event of contact,
rinse thoroughly and refer to a doctor.
lRegularly wipe the power supply connector with a soft and dry cloth.
lAfter lengthy storage, charge and discharge the MINILED 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.
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 MINILED.
Check that the cord does not hinder the movement or free circulation of anyone whilst the MINILED is charging. Make
sure that it is not possible to wheel over or walk on the cord. Plug the mains adapter plug into the MINILED.
5.3 Charge the battery
The MINILED operates with a Lithium-Ion battery. To guarantee optimum use, this battery must be fully charged before
use but must never be flat.
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Check the contact between the charging base connectors and the battery connectors.
The MINILED is placed securely on the charging base when a double beep sounds and the handpiece support light
flashes blue.
It takes about 3 hours to charge the battery.
Replace the MINILED on the charging base after each use for optimised battery efficiency.
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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 MINILEDSUPERCHARGED accessories include:
la charging base;
lan optical guide;
la rigid protection shield.
Refer to the cleaning, disinfection and sterilisation protocols for accessories listed in the chapter Associated
documentation page 3.
6.2 Preparation for use
To prepare your MINILED, follow the steps below:
lClean and disinfect the rigid protection shield with an alcohol wipe.
lClean and disinfect the handpiece with an alcohol wipe.
lSterilise the optical guide.
lPlug the charging base into the mains.
lCheck that the translucent handpiece support flashes three times (red, green, blue) and that a beep sounds
when it is switched on.
lRemove the insulating ring located between the battery and the MINILED and screw the battery onto the
handpiece.
lPlace the MINILED on its charging base.
lThe MINILEDSUPERCHARGED is correctly installed when two beeps are heard and the translucent support
base lights up in blue and starts flashing.
lLeave the MINILED to fully charge.
lThe MINILEDSUPERCHARGED is charged when the translucent support base stops flashing and remains lit up
in blue.
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 medical device must be disconnected from its power supply during dental treatments.
Before each use, check that the light intensity is compliant using a purpose-designed testing means or by
making a test on a small piece of light-curing composite, or, depending on the configuration, the power tester
built into the charging 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 21.
The patient and the practitioner must wear class II safety goggles when the MINILED is in operation.
6.4.1 Switching on the medical device
Press the button to switch on the MINILED.
If the MINILED has switched to standby, press one of buttons to exit standby mode.
6.4.2 Configuring the medical device
6.4.2.1 Selection of the mode
Press the button to select the required exposure mode.
6.4.2.2 Selecting the exposure time
Press the button to select the required exposure time:
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Mode Exposure time
Fast
3seconds
4seconds
5seconds
10seconds
Pulsed 5 1-second bursts, with 250-millisecond intervals between each burst
10 1-second bursts, with 250-millisecond intervals between each burst
Progressive 6 seconds progressive and 3 seconds at full power
10 seconds progressive and 5 seconds at full power
Available exposure times
6.4.3 Performing a cure cycle
1. Position the end of the optical guide 2mm from the surface of the composite to be cured. Do not touch it.
2. Press the button to start the cure cycle.
A beep sound confirms start of the cycle. During the cycle, the remaining cycle time counts down on the
MINILED LCD screen.
A second beep sound confirms cycle completion.
Depending on the cure composite used, repeat the cure cycle as required.
6.5 Switching off the medical device
1. Press the button to stop a cure cycle.
2. Replace the MINILED on the charging base after each use for optimised battery efficiency.
After 5 minutes of inactivity, the MINILED switches to standby and the on/off light indicator goes off.
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 Screen of the medical device
The MINILED SUPERCHARGED has a backlit LCD screen which displays information about the device condition for the
user:
Four battery charge level indicators are shown to signal that the battery is fully charged.
When the last battery charge level indicator is shown and two beeps sound, charge the battery. About 500 seconds
of polymerisation remaining.
When the battery is completely flat, the LCD screen displays the message “Lb” (Low battery) and no longer displays any
round pictograms, the handpiece beeps four times and the light indicator turns red.
7.2 Light indicator
Colour Meaning
Flashing blue The battery is charging
Fixed blue Charge fully completed
Red Power measured is insufficient for required operation
Green Power measured is sufficient
Charging base light indicator
7.3 MINILED SUPERCHARGED
The MINILED can only be used with the following accessories:
lOpalescent optical guide, 45° curve, 7.5 mm
lOpalescent optical guide, 45° curve, 5.5 mm
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. The protection plug must be installed when the handpiece is being cleaned. An
insulating ring protects the battery connectors.
7.4 Base
The MINILED charging base comprises a power tester. This is used to test correct operation of the MINILED.
The charging base comprises a handpiece holder on which the handpiece can be placed before and after use.
7.5 Operating mode
Rapid mode activates maximum power of the MINILED for the selected exposure time.
The first pulsed mode (05 is displayed) activates maximum power of the MINILED in five successive bursts lasting 1
second at 250ms intervals.
The second pulsed mode (10 is displayed) activates maximum power of the MINILED in ten successive bursts lasting 1
second at 250ms intervals.
The first progressive mode (09 is displayed) initiates a gradual rise in power lasting 6 seconds followed by 3 seconds at
full power.
The second progressive mode (15 is displayed) initiates a gradual rise in power lasting 10 seconds followed by 5
seconds at full power.
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7.6 Buttons
The MINILED has three buttons.
located between the LCD screen and the optical guide used to start up the MINILED and to start or stop the
cure cycle.
used to select the modes.
used to select the exposure time.
7.7 Wave peak
7.5mm-diameter opalescent optical guide
Centre wavelength 455nm - 465nm
Maximum irradiance at 2 mm 2,000mW/cm2standard ±10%
7.8 Waveform with micro-flash
Exposure time Waveform (nominal value, irradiance, duration) Average irradiance over time
1 second 2000mW/cm2standard
7.9 Mains adapter
The mains adapter is part of the medical device and helps to ensure its electrical safety. It must be installed near the
medical device and must be readily accessible.
The mains cord connects the mains adapter to the medical device
Only use the mains adapter supplied with your medical device.
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