ACTEON Equipment Mini LED User manual

User Manual
Mini LED™

This document is an English translation of the original French version.
Reference J02540 version V6 and drawing number NG13FR010F

Contents
1 Documentation 5
1.1 Associated documentation 5
2 Required information 7
2.1 Operating principle 7
2.2 Date of first inclusion of EC marking 7
2.3 Latest document update 7
2.4 Repairing or modifying the medical device 7
2.5 Warranty 7
2.6 Accessory usage conditions 7
3 Removal from packaging, installation, connections 9
3.1 Removing the medical device from its packaging 9
3.2 Installing the medical device 9
3.3 Connecting the medical device to the electrical network 10
3.4 Installing the mains adapter 10
3.5 Fixing the medical device to a non-removable support 10
4 Medical device description 11
4.1 First use 11
4.2 Using the Mini LED 11
4.3 Mini LED™ 11
4.4 Connecting and disconnecting accessories during use 12
4.5 Light indicator 12
4.6 Buttons 12
4.7 Charging 12
4.8 Mains adapter 12
4.9 Operating modes 13
4.9.1 Wave peak 13
4.9.2 Waveform 13
4.9.3 Cure depth 14
4.10 Switching off the medical device 14
4.11 Disconnecting the medical device 14
5 Cleaning, disinfecting and sterilising 15
5.1 Cleaning and disinfecting the Mini LED 15
5.2 Cleaning, disinfecting and sterilising accessories 15
6 Monitoring the medical device 17
7 Maintenance 19
7.1 Checking the lamp power level 19
7.2 Identifying incorrect operation 19
7.2.1 Not working 19
7.3 The power of the Mini LED is not as expected 19
7.4 Other malfunctions 20
8 Technical specifications of the medical device 21
8.1 Identification 21
8.2 Mains Adapter 21
8.3 Optical Guide 21
8.4 Mini LED handpiece 21
8.5 Technical specifications of the battery 21
8.6 Charging base 22
8.7 Environmental characteristics 22
8.8 Environmental restrictions 22
8.9 Main performance characteristics 22
9 Regulations and standards 23

9.1 Applicable standards and regulations 23
9.2 Medical class of the device 23
9.3 Symbols 23
9.4 Manufacturer identification 24
9.5 Branch addresses 25
9.6 Disposal and recycling 26
10 Index 27
11 Glossary 29

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 your medical device's technology, please read the documentation provided
carefully.
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.
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.

1 Documentation
This document contains the following information:
lindications for use;
lmedical device description;
linstallation of the medical device;
lmedical device use;
lpreparation prior to cleaning and disinfecting 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
Protocole de nettoyage, désinfection et stérilisation du guide optique Mini LED Acteon J02940
Protocole de nettoyage et désinfection de l'écran de protection rigide Mini LED Acteon J05540
Notice générale relative à l'ensemble de la gamme des lampes à polymériser de table Acteon J02920
Mode de consultation des instructions d'emploi électroniques J00000
Mini LED™ User Manual J02541
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2 Required information
This medical device is designed to cure photosensitive reconstruction and bonding materials 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 sleeve.
2.1 Operating principle
Designed to light-cure dental materials, 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. 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.
The wavelength of the light source corresponds to that of the photo-initiators used in dental curing materials.
2.2 Date of first inclusion of EC marking
2007
2.3 Latest document update
07/2016
2.4 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.
2.5 Warranty
The user must not disassemble the base, the battery or the handpiece as this will void the medical device's warranty.
2.6 Accessory usage conditions
The optical guide must be cleaned and sterilised before being used. The rigid protection shield must be cleaned before
being used.
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3 Removal from packaging, installation,
connections
3.1 Removing the medical device from its packaging
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 Mini LED handpiece;
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.
3.2 Installing the medical device
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.
Do not install your medical device near or on another device.
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Install the charging base of your Mini LED on a flat surface with a slope of less than 5°.
3.3 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/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.
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.
3.4 Installing the mains adapter
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.
3.5 Fixing the medical device to a non-removable support
Your medical device is not designed to be moved. To avoid dropping the device, we recommend that you fix it in a
precise place in your treatment room, using the mounting kit supplied in the packaging box, to ensure that it cannot be
dismantled or moved without needing a tool.
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4 Medical device description
4.1 First use
The Mini LED uses a Lithium-Ion battery. To guarantee optimum use, this battery must be fully charged before use but
must never be flat. To prepare your Mini LED, follow the steps below:
lclean the rigid protection shield with an alcohol wipe;
lclean 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 nozzle;
linsert the sterilised optical guide into the handpiece nozzle;
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.
4.2 Using the Mini LED
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 chapitre Checking the lamp power level page 19.
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.
4.3 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. The protection plug must be installed when the handpiece is being cleaned.
Another transparent plastic protection plug protects the battery connectors.
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4.4 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 with the patient or any other party.
Do not disconnect the optical guide or the rigid protection shield when using your Mini LED.
4.5 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/cm2is 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
4.6 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.
4.7 Charging
The Mini LED charging base comprises a power tester. This is used to test correct operation of the Mini LED.
4.8 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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4.9 Operating modes
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.
4.9.1 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
4.9.2 Waveform
Waveform (nominal value, irradiance, duration) Average irradiance over time
Rapid mode 1250 mW / cm2
925 mW / cm2
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Waveform (nominal value, irradiance, duration) Average irradiance over time
Pulsed mode 1020 mW / cm2
754 mW / cm2
Progressive mode 937 mW / cm2
693 mW / cm2
4.9.3 Cure depth
Cure depth in mm with a distance of 2 mm between the optical guide and the cure material
Rapid mode Pulsed mode Progressive mode
Z100 MP, 3M 3mm/2.5mm 2 mm/2.5mm 3mm/2.5mm
Tetric EvoCeram, Ivoclar Vivadent 2 mm/1.5 mm 1.5 mm/1.5 mm 2 mm/2 mm
Charisma, Heraeus - Kulzer 2 mm/2 mm 2 mm/1.5 mm 2.5 mm/2 mm
4.10 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.
4.11 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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5 Cleaning, disinfecting and sterilising
The instructions relating to cleaning, disinfection and sterilisation protocols for the medical device and accessories
provided by SATELEC, a company of Acteon group have been approved for each medical device and accessory. The
applicable guides are listed in the chapitre 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 cleaning, disinfection and sterilisation protocols for
accessories take precedence over the information provided by SATELEC, a company of Acteon group.
5.1 Cleaning and disinfecting the Mini LED
The Mini LED must be OFF during cleaning and disinfecting procedures. It must also be disconnected from its electricity
supply.
Avoid using cleaning and disinfection products that contain flammable agents. Otherwise, ensure that the product has
completely evaporated or that there is no fuel left on the medical device and its accessories before switching it on.
Do not use an 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.
Use alcohol disinfectant wipes.
lUnplug the power cord from the base.
lRemove the rigid protection shield.
lRemove the optical guide.
lBlock the Mini LED handpiece nozzle with a protection plug.
lClean the body of the Mini LED handpiece with an alcohol wipe.
lClean the Mini LED base with an alcohol wipe.
lClean the rigid protection shield as indicated in the instructions in the chapitre Associated documentation page 5
lClean and sterilise the optical guide as indicated in the instructions in the chapitre Associated documentation
page 5
5.2 Cleaning, disinfecting and sterilising accessories
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 chapitre Associated
documentation page 5.
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6 Monitoring the medical device
Before and after use, check the medical device and its accessories entirely for any problems. This is necessary to
detect any isolation fault or damage. If necessary, replace damaged parts.
Check the cleanliness of the handpiece nozzle. It must be clean, smooth and corrosion-free. The optical guide must fit
easily and firmly inside it.
Check the handpiece electrical connectors. These must be clean, smooth and corrosion-free. The battery must be able
to be screwed in easily.
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