This document is an English translation of the original French version.
Reference J02540 version V5 and drawing number NG13FR010E
Page 3
Contents
1 Documentation5
1.1 Associated documentation5
2 Required information7
2.1 Indication for use7
2.2 Operating principle7
2.3 Date of first inclusion of EC marking7
2.4 Latest document update7
2.5 Repairing or modifying the medical device7
2.6 Warranty7
2.7 Accessory usage conditions7
3 Removal from packaging, installation, connections9
3.1 Removing the medical device from its packaging9
3.2 Installing the medical device10
3.3 Connecting the medical device to the electrical network10
3.4 Installing the mains adapter10
4 Medical device description11
4.1 First use11
4.2 Using the Mini LED11
4.3 Mini LED™11
4.4 Connecting and disconnecting accessories during use12
4.5 Light indicator12
4.6 Buttons12
4.7 Base12
4.8 Mains Adapter12
4.9 Operating modes13
4.9.1 Wave peak13
4.9.2 Waveform in each mode13
4.10 Switching off the medical device14
4.11 Disconnecting the medical device14
5 Cleaning, disinfecting and sterilising15
5.1 Cleaning and disinfecting the Mini LED15
5.2 Cleaning, disinfecting and sterilising accessories15
6 Monitoring and general maintenance of the medical device17
7 Maintenance19
7.1 Checking the lamp power level19
7.2 Identifying incorrect operation19
7.2.1 Not working19
7.3 The power of the Mini LED is not as expected19
7.4 Other malfunctions20
8 Technical specifications of the medical device21
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8.1 Identification21
8.2 Mains Adapter21
8.3 Optical Guide21
8.4 Mini LED handpiece21
8.5 Technical specifications of the battery22
8.6 Charging base22
8.7 Environmental characteristics22
8.8 Environmental restrictions22
8.9 Main performance characteristics22
9 Regulations and standards23
9.1 Official Texts23
9.2 Medical class of the device23
9.3 Symbols23
9.4 Manufacturer identification24
9.5 Branch addresses25
9.6 Disposal and recycling26
10 Index27
11 Glossary29
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Foreword
The SATELEC®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®Mini LED for information
about the following:
l documentation format;
l documentation archiving period;
l warnings concerning user and patient populations;
l treatment area;
l medical device usage interactions, contraindications and prohibitions;
l electromagnetic compatibility;
l disposal and recycling of the medical device;
l manufacturer 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:
l preparation of parts for sterilisation;
l detailed manual and automated instructions;
l information concerning conditioning for sterilisation;
l recommendations for the inspection of parts.
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1 Documentation
This document contains the following information:
l indications for use;
l medical device description;
l medical device installation;
l medical device use;
l preparation prior to cleaning and disinfecting the medical device;
l monitoring and general maintenance of the medical device;
l maintenance to be performed by the user.
1.1 Associated documentation
This document must be used in association with the following documents:
Document titleReferences
Cleaning, disinfection and sterilisation instructions for the SATELEC®Mini LED optical guide
J02941
Cleaning and disinfection instructions for the SATELEC®Mini LED rigid protection shield
General instructions relating to the SATELEC®complete range of table curing lamps
Consulting electronic user instructionsJ00000
Mini LED™ User ManualJ02541
J05541
J02921
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2 Required information
2.1 Indication for use
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 shield.
2.2 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.
2.3 Date of first inclusion of EC marking
2007
2.4 Latest document update
01/2015
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®.
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®customer service team:
SATELEC®at the request of technical personnel working for the network of dealers approved by
SATELEC®, provides all information required to repair the faulty parts on which they may perform
repairs.
2.6 Warranty
The user must not disassemble the base, the battery or the handpiece as this will invalidate the medical
device's warranty.
2.7 Accessory usage conditions
The optical guide must be cleaned and sterilised being 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:
l a 7.5 mm-diameter multi-fibre optical guide with its ferrule;
l depending on the option, a 7.5 mm-diameter, amber-coloured multi-fibre optical guide with its ferrule;
l a Mini LED handpiece;
l two protection plugs for the handpiece;
l a charging base with an integrated power tester;
l a Lithium-ion battery;
l a rigid protection shield;
l a mains adapter.
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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.
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
Check that the mains voltage is compatible with that indicated on the medical device or its mains adapter.
Next, connect the mains adapter to the wall socket in compliance with the standards in force in the country of
use.
A different voltage would cause damage to the medical device and could injure the patient and/or user. Any
variation in the electrical network voltage or electromagnetic field that is non-compliant with the limits in
force, could interfere with the medical device's operation.
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.
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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:
l clean the rigid protection shield with an alcohol wipe;
l clean the handpiece with an alcohol wipe;
l plug the charging base into the mains;
l check that the green indicator light on the base lights up twice and listen out for a beep sound;
l install the battery on the handpiece;
l place the Mini LED on its charging base;
l the Mini LED is correctly installed when two beeps are heard and the green indicator light on the base
starts flashing;
l leave the Mini LED to fully charge;
l the Mini LED is charged when the green indicator light on the base stops flashing and remains on
permanently;
l remove the protection plug from the handpiece nozzle;
l insert the sterilised optical guide into the handpiece nozzle;
l you will hear a click when the optical guide is correctly inserted;
l install the rigid protection shield;
l wear safety goggles and protective gloves;
l provide 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 chapter 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.
l Remove the Mini LED from the base;
l Press the on/off button.
l Install the rigid protection shield;
l Programme the Mini LED to select the required mode;
l Position 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.
l Press the on/off button to trigger the selected mode. A beep sound confirms cycle initiation;
l A 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.
4.3Mini LED™
The Mini LED can only be used with the following accessories:
l 7.5 mm opalescent optical guide [F02648]
l 7.5 mm amber-coloured optical guide [F02620]
l Mini LED titanium battery [F02520]
l Mini LED handpiece [F02530]
l Protection plug [F57347]
l Rigid protection shield [F02555]
l Charging base and mains adapter [F02544]
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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.
4.4 Connecting and disconnecting accessories during use
Never release the battery when the Mini LED is being used. 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.
On/off light indicator
ColourMode
GreenNormal mode
RedThe battery is flat
Flashing redThermal cut-out activated
Three operating mode light indicators
IndicatorPictogramColourMode
HighGreenFast
MediumGreenPulsed
LowGreenProgressive
The charging base has two light indicators.
Charging base light indicators
ColourMeaning
Flashing green - upper indicatorCharging
Green - upper indicatorCharge carried out and finished
Red - lower indicator
Green - lower indicator
Power measured at less than 930 mW/cm2and insufficient for required operation
Power measured equal to or greater than 1100 mW/cm
2
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 Base
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.
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The mains cord connects the mains adapter to the medical device
Only use the mains adapter supplied with your medical device.
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
Wave peak447.5 nm447.4 nm
Maximum irradiance at 2 mm
Mean spectral irradiance in relation to the nominal value and
over time
1900 mW / cm
1250 mW / cm
2
2
Amber-coloured optical
guide
1300 mW / cm
925 mW / cm
2
2
4.9.2 Waveform in each mode
Waveform (nominal value, irradiance, duration)Average irradiance over time
Rapid mode
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1250 mW / cm
925 mW / cm
2
2
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Waveform (nominal value, irradiance, duration)Average irradiance over time
2
2
2
2
Pulsed mode
Progressive mode
1020 mW / cm
754 mW / cm
937 mW / cm
693 mW / cm
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®have been approved for each medical device and accessory. The applicable
guides are listed in the chapter Associated documentation page 5.
They can be downloaded at the following address: www.satelec.com/documents.
In all cases, the local regulations in force relating to the cleaning, disinfection and sterilisation instructions for
accessories take precedence over the information provided by SATELEC®.
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.
l Unplug the power cord from the base.
l Remove the rigid protection shield.
l Remove the optical guide.
l Block the Mini LED handpiece nozzle with a protection plug.
l Clean the body of the Mini LED handpiece with an alcohol wipe.
l Clean the Mini LED base with an alcohol wipe.
l Clean the rigid protection shield as indicated in the instructions in the chapter Associated documentation
page 5
l Clean and sterilise the optical guide as indicated in the instructions in the chapter Associated
documentation page 5
5.2 Cleaning, disinfecting and sterilising accessories
The Mini LED accessories include:
l a charging base;
l an optical guide;
l a rigid protection shield.
Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated
documentation page 5.
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6 Monitoring and general
maintenance of 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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7 Maintenance
The only preventive maintenance the medical device requires is:
l monitoring of accessories;
l everyday cleaning, disinfection and sterilisation;
l cleaning.
7.1 Checking the lamp power level
It is important to regularly check that the lamp is working correctly. To do this, follow the steps below:
l Check that the optical guide is intact and has no composite residues.
l Set the lamp to Rapid mode.
l Insert the optical guide into the power tester.
l Switch on the Mini LED.
l The power tester may give the following results:
ColourResult
Green
The lamp is working correctly and has a power output equal to or more than 1000 mW per cm2
Red
The lamp is not working correctly. Please read the chapter Identifying incorrect operation page 19
7.2 Identifying incorrect operation
In the event of incorrect operation, refer to the tables below to quickly identify and repair the non-complex
parts of the medical device.
If the incorrect operation is not described in the tables below, please contact your supplier or the Customer
Service Team at SATELEC®.
Do not use the medical device if it appears to be damaged or faulty. Isolate the medical device and make sure
that it cannot be used.
7.2.1 Not working
Symptoms: The Mini LED does not switch on and does not emit blue light.
Possible causesSolutions
The on/off button is set to offPress the on/off button to switch on the Mini LED
The battery is flatCharge the battery
l Disconnect the charging base;
The charging base is incorrectly connected to
the mains power preventing the battery from
charging normally
The battery switched itself to safety modeInstall another battery
The internal temperature of the Mini LED has
reached the maximum permitted level
The battery charging light is red. The battery
was not fully charged before being switched on
l Check that the socket is not faulty;
l Connect the charging base;
l Check that the charging light comes on;
l Wait for the battery to fully charge.
Allow the Mini LED to cool before using it again
Remove the partly charged battery and install a fully charged battery
7.3 The power of the Mini LED is not as expected
Possible causesSolutions
Cure composite residue remains on the optical
guide
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l Remove the residue.
l Check that the surface of the optical guide is intact.
l Change the optical guide if necessary.
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Possible causesSolutions
The optical guide is damaged or is not clean
The power of the Mini LED has changedCheck the power using a purpose-designed tester
Clean the optical guide using the multi-purpose syringe air
function
7.4 Other malfunctions
If the Mini LED™ is not working for any other reason, contact the SATELEC®Customer Services Team.
If you need to return your Mini LED, please ensure the optical guide and battery are packaged to prevent any
impact damage during transportation.
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8 Technical specifications of the
medical device
8.1 Identification
Manufacturer
Name of the medical deviceMini LED™
SATELEC
8.2 Mains Adapter
ManufacturerFriwo
Supply voltage100 - 240 VAC
Power supply frequency50 Hz / 60 Hz
Drawn current250 mA
Output voltage12 V
Output current800 mA
Width58 mm
Height66 mm
Depth35.5 mm without the plug
Weight151 g
Ingress protection ratingIP 40
®
8.3 Optical Guide
Weight23 g
Length94 mm
Distal end diameter7.5 mm
Active diameter6.8 mm
Optical cross-section
0.36cm
8.4 Mini LED handpiece
Length112 mm
Maximum outer diameter
Weight72 g
Ingress protection ratingIPX0
Distance with user0 cm - 70 cm
Number of LED lights4
Wavelength range440 nm - 460 nm
Mean wavelength450 nm
Irradiance with opalescent optical guide
Irradiance with amber-coloured optical guide
Operating modeContinuous
23 mm
1125 mW / cm2- 2400 mW / cm
785 mW / cm2- 1680 mW / cm
2
2
2
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SafetyThermal
TypeB
8.5 Technical specifications of the battery
Capacity2500 mA / hr
Output voltage3.7 V - 4.2 V
TypeLithium-ion
Maximum diameter23 mm
Length99 mm
Weight74 g
8.6 Charging base
Supply voltage12 V DC
Protection3 A / 125 V AC fuse
8.7 Environmental characteristics
Operating temperature+10°C to +30°C
Storage temperature0°C to +50°C
Operating humidity30 % to 70 %
Atmospheric storage pressure500 hPa to 1060 hPa
Atmospheric operating pressure800 hPa to 1060 hPa
Maximum operating altitudeEqual to or less than 2000 metres
8.8 Environmental restrictions
Usage premises
Use in gas-filled atmosphere The Mini LED is not designed to be used in an AP or APG gas-filled atmosphere.
ImmersionThe Mini LED must not be immersed.
Designed for use in all medical establishments, the medical device cannot be used
outside.
8.9 Main performance characteristics
Wavelength between 440 and 460 nm.
Irradiance of 1125 mW / cm2 to 2400 mW / cm2, calculated based on the active diameter of 6.8 mm with the
opalescent optical guide.
Irradiance of 785 mw / cm2- 1680 mW / cm2, calculated based on the active diameter of 6.8 mm with the
amber-coloured optical guide.
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9 Regulations and standards
9.1 Official Texts
This medical device complies with the essential requirements of European Directive 93/42/EEC. It was
designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system.
9.2 Medical class of the device
Class of medical device: I according to 93/42/EEC directive
9.3 Symbols
SymbolsMeaning
Refer to the accompanying documentation
Consult the User Manual
The accompanying documentation is available in electronic format
Do not use the medical device if the patient or practitioner are fitted
with an implantable device
Always wear safety goggles
Always wear protective gloves
Sterilisation at 134°C in an autoclave
Sterilisation at 132°C in an autoclave
Washer-disinfector for thermal disinfection
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SymbolsMeaning
Ultrasonic bath
EC marking
Do not dispose of as household waste
Year of manufacture
YYYY
IP: ingress protection ratings procured by a range
IPX1
Rx only
X: no ingress of protection rating claim against the penetration of solids
1: protects against the vertical falls of drops of water
Under the United States Federal Law, this medical device must only be sold
by or under the orders of a qualified doctor.
On/off button
Programme selection button
9.4 Manufacturer identification
SATELEC
A Company of ACTEON Group
17, avenue Gustave Eiffel
BP 30216
33708 MERIGNAC cedex
FRANCE
Tel. +33 (0) 556.34.06.07
Fax. +33 (0) 556.34.92.92
E.mail: [email protected].
www.acteongroup.com
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9.5 Branch addresses
U.S.A. & Canada
ACTEON North America
124 Gaither Drive, Suite 140
Mount Laurel, NJ 08054 - USA
Tel. +1 856 222 9988
Fax. +1 856 222 4726
[email protected]
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9.6 Disposal and recycling
As an Electrical and Electronic item of Equipment, the medical device must be disposed of via a specialist
collection, removal, recycling or destruction channel. This applies in particular to the European market, in
reference to Directive2002/96/EC dated 27/01/2003.
When your medical device has reached the end of its service life, contact your nearest dental equipment
dealer, or ACTEON GROUP head office or one of the company branches to find out how to proceed. The
relevant contact details are given in the chapter Branch addresses page 25.
The indication below applies to France only.
In compliance with the provisions of the French Environment Code relating to the disposal of electronic and
electrical equipment waste or DEEE (Decree no. 2012-617 dated 2 May 2012), our Company fulfils its
obligations to reclaim and dispose of its electrical and electronic equipment through the means established by
the approved organisation Recydent (NOR approval: DEVP1229534A).
As a producer, our Company is listed in the National Register of Producers kept by the ADEME (French
Environment and Energy Management Agency). Professionals buying our products directly from the distribution
chain are responsible for passing on this information about our established recycling methods to the end user.
In addition, the buyer agrees to take back our brand's devices at the end of their service life and to transfer
them to one of the collection centres set up by Recydent for recycling (see list of collection centres on the site
Recydent.fr).
If necessary, Recydent can come and collect these devices from you free of charge once the quantity of
devices has reached a certain level in the pallets-containers with which you are provided to store this waste.
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Glossary: Active diameter – Wavelength peak
P
11 Glossary
A
Active diameter
area of the effective optical cross-section of the
LED light beam at the optical guide tip
F
Ferrule
metal ring placed on the end of the optical guide.
Makes it easier to insert the optical guide into the
handpiece nozzle and prevents the optical guide
from rotating. Also known as a collar
Flexible protection shield
available in 5.5 mm-diameter and 7.5 mm-diameter sizes. In contact with the patient, it must
be sterilised after each use. Suitable for autoclaving. Previously called the cup
Protection plug
two plastic plugs used to protect the handpiece
connectors and electronics during cleaning. One
fits on the nozzle and the other fits onto the handpiece's electrical connectors
R
Rigid protection shield
removable oval shield forming an integral part of
the handpiece once in place. Is cleaned with
wipes.Not suitable for autoclaving
W
Wavelength peak
maximum amplitude of a wavelength spectrum
I
Irradiance
term used in radiometry to quantify the power of
an electromagnetic radiation per unit area. It is
expressed in watts per square metre. Often confused with the power of a light source
L
LED
electroluminescent diode, more commonly known
as Led (light-emitting diode), designates an optoelectronic component that allows the emission of
monochromatic light.
O
Optical guide
light conductor fitted to the handpiece nozzle and
transmitting light to the cure site. Is cleaned and
is suitable for autoclaving
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Ref: J02541 • V5 • 07 • 01/2015 • NG13EN010E
A Company of AC TEON Group • 17 av. Gustave Ei ffel • BP 30216 • 33708 MERIGNAC cedex • France