Dentmate LEDEX WL-070 User manual

Instruction manual · Manuale d’uso ·Bruksanvisning
Uživatelský manuál ·Manuel d’utilisation ·Bedienungsanleitung

Thank you for choosing DENTMATE LEDEXTM WL-070 Dental curing light.
A lot of researches & developments have gone into the manufacturing of
this product. We sincerely hope that it will give you many years of trouble-
free use. Please read and understand all the instructions before using this
equipment, and save this manual for your reference.
The manual is subject to change without further notice.
Abbiamo effettuato una lunga ricerca e sviluppo nella produzione di questo
prodotto e speriamo sinceramente che vi dia molti anni di utilizzo perfetto.
Si prega di leggere e capire tutte le istruzioni di questa apparecchiatura
prima dell’uso, e di tenere da parte questo manuale come riferimento.
Mycktet forskning och utveckling ligger bakom tillverkningen av den här
ljushärdningslampan och vi hoppas att den kommer att ge dig många år av
problemfritt användande.
Var snäll och läs igenom och förstå denna instruktion före användning, och
spara bruksanvisningen som ett referensmaterial.
Věříme, že Vám náš výrobek bude po dlouhá léta bez problému sloužit.
Prosíme, přečtěte si následující informace před použitím a uchovejte návod
po pozdější potřebu.
Ce produit a été fabriqué à l’issue d’importants travaux de recherches et
de développement. Nous espérons qu’il vous donnera entière satisfaction
durant de nombreuses années d’utilisation.
Veuillez lire et prendre connaissance de l’ensemble des instructions avant
d’utiliser cet équipement. Conserver ce manuel d’utilisation pour pouvoir
vous y référer à tout moment.
Für die LEDEX™ WL-070 Polymerisationslampe wurden ausschließlich
hochwertige Materialien verwendet und ist nach neusten Forschungen
entwickelt worden. Wir hoffen aufrichtig dass sie Ihnen ein sorgenfreies
und angenehmes Arbeiten ermöglicht.
Bitte lesen Sie alle Anweisungen, bevor Sie das Produkt benutzen. Bitte
bewahren Sie diese Bedienungsanleitung in Ihrem eigenen Interesse auf.
EN
IT
SV
CZ
FR
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Table of Contents
1. Symbols Used 1
1.1. In this instructions manual 1
1.2. On the product/packaging 1
2. Product Information and Operation 2
2.1. Indications for use 2
2.2. Procedure 2
2.3. System components 3
2.4. Features 4
2.5. Display 4
2.6. Charging the battery and plug-in use 5
2.7. Check the status of the battery 6
2.8. The setting of beep sound 6
2.9. Output/interrupt the light 7
2.10.Safety status 8
2.11.Automatic sleep mode 8
3. Contraindications 8
4. Warnings 9
4.1. User 9
4.2. Ambient conditions 9
4.3. To avoid electric shock(shock hazard) 10
4.4. Heat development (burn hazard) 10
4.5. Battery 10
4.6. Accessories 11
4.7. Repairs and defects 11
4.8. Transport 11
5. Precaution 12
6. Troubleshooting 12
7. Daily Maintenance 13
8. Disposal 13
9. Warranty 13
10. Product Specifications 14
11. EMC Declaration Of Conformity 15
12. Manufacturer’s Declaration 15

1. Symbols Used
1.1. In these instructions for use
If the instructions are not followed properly, operations may
lead to hazards for the product or the user/patient.
WARNING
1.2. On the product/packaging
Serial number Catalogue number
Manufacturer Date of manufacture
Class II (AC Adapter) Consult the
Instructions for use
This shows the Type
B applied part.
Do not dispose
it with normal
household waste
Recycling Ordinary equipment
EU-representative Atmospheric
pressure for storage
Temperature limits Storage humidity range
CE marking Keep dry
95%
10%
106kPa
50kPa
10° C
40° C
EN
1

2. Product Information and Operation
The light of the product is super-high luminosity LED. The light wavelength is
between 440 and 480 nm, and the light intensity is from 1000 to 1200 mw/cm².
These characteristics enable the light to polymerize almost all photosensitive
composite resins.
LEDEXTM WL-070 dental curing light is characterized as followed:
• The light guide rod is made from genuine optical fiber minimizes loss of light from
source to tip. It ensures the highest possible intensity of light at the light guide
tip.
• Advanced and high efficient cooling heat sink designed accompany with over
temperature protection. A thermal protection circuit and safety mode are also
designed to prevent the light from overheating.
• The automatic memorization of the last operation chosen is another unique
feature of the light.
• Cordless / cord combo gives the operator flexability to use. Operator can use
with or without the charging cord plug-in.
• Automatic sleep mode saves battery and extends usage time.
2.1. Indications for use
LEDEX WL-070 is a visible curing unit designed for polymerization of dental light
cured materials used only by dental professionals.
2.2. Procedure
Please follow the insturction before use. As for handpiece instuctions, please refer
to 2.6-2.9. It is required to use the disposable sleeves to prevent cross infection.
Put the sleeve and cover the handpiece before operation. After conducting a
sugery on a patient, please take off the sleeve and throw away, as the sleeve is
prohibited to reuse.
2

2.3. System components
d
LEDEX™ WL-070 Handpiece
Power supply (Input AC100~240
V , 50-60 Hz, Output DC 5 V/ 2 A)
Optical fiber light guide rod
(Ø8 mm)
1
1
1
Item Description Quantity
a
b
c
e
f
g
h
i
Instructionsfor use
Only 120g
Light As Cloud
Disposable curing light sleeve
Disposable light guide sleeve
Instructionsmanual
Holder
Filter
Anti-glare shield
1
1
2
10
20
1
abc
def
ghi
EN
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2.4. Features
ON/OFF :Press this button start the handpiece. Press
this button again to turn on the curing light. Pressing
this button during the curing cycle will interrupt and
end the cycle. If the unit is in sleep mode, press this
button will wake the unit and it will display with the last
mode choosen.
Screen :Display second.
MODE :Push the MODE button, the time would be
changed as followed 10 secs →20 secs →30 secs →40
a
b
c
2.5. Display
b
c
a
Different modes and output power would be displayed on the screen as below:
Stand mode output 10 seconds.
Ramp mode output 20 seconds.
Ramp mode output 30 seconds.
Stand mode output 40 seconds.
4

Connect the power supply to AC100~240 V
electronic socket and plug-in the connector to
LEDEXTM WL-070 hand piece. Push the ON/OFF
button to turn on the LEDEXTM WL-070 hand
piece.
When the battery is charging, the Display will
glow and show the sign of “CH”.
When the battery is fully charged, the Display
will glow and show the sign of “FC”.
The battery is only charged to about 60% prior to the shipment. Each time,
charge it fully before using it.
2.6. Charging the battery and plug-in use
Charging Fully
charging
Plug-in use
When the battery is malfunctioned and can’t
be charged, you still can use LEDEXTM WL-070
handpiece.
Connect the power supply to AC100~240 V
electronic socket and plug-in the connector to
the LEDEXTM WL-070 hand piece. Even when
the battery is in the low status, you still can use
LEDEXTM WL-070 hand piece.
EN
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2.7. Check the status of the battery
Battery Status Numerical
Fully charged ≥4.2
General 4.1~3.5
Low ≤3.4
a). Push and hold the MODE button for more than
4 seconds.
b). Read the numerical code that shows on the
display.
When the battery is in a low status, the display will
glow and show the sign of “Lo”.
Press the MODE button for 6 seconds until the
display shows or .
2.8.
The setting of beep sound
6

2.9. Output/interrupt the light
Push the MODE button, the time would be changed as
followed 10 secs →20 secs →30 secs →40 secs →10
secs →20 secs...
When LEDEXTM WL-070 hand piece is turned on, push
the ON/OFF button again to output the light. Final
countdown will be showed on the display.
During the exposure time, the operator can push
the ON/OFF button to turn off the light. Then the
system will generate one beep and reset the time
automatically.
Wait for 3 seconds. When display shows the
second again, the system will memorize the
setting and save it as default.
Press the MODE button again to switch
between or .
Mute
Unmute
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2.11. Automatic sleep mode
3. Contraindications
For patients who are prone to photobiological reactions :
Do not use the LEDEXTM WL-070 dental curing light for patients with a history of
photobiological reactions (including patients with Urticaria solaris or erythropoietic
protoporphyria) or those who currently have treatments with photosensitising
pharmaceuticals.
LEDEXTM WL-070 sleeps automatically if no operations are performed for three
minutes, and the display will be turned off.
2.10. Safety status
After the LEDEXTM WL-070 is operated for long period of time, the temperature
may become too high. Hence, the safety mode will then be activated automatically
to prevent the light from overheating. The safety mode will cut the light intensity in
approx half and extend the irradiation time.
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4. Warnings
The handpiece is intended for the polymerization of light-cured
materials and is used only by trained and qualified professionals,
such as dentists.
Do not place the device in humid surroundings or any places
which are close to any liquids.
Do not expose the device to any heat sources. Store the device in
a safe environment.
• The device could be operated up to a maximum temperature of
35 °C and up to an altitude of 2,000 m above sea level.
• Do not use the device in the presence of free oxygen,
anesthetics or flammable substances.
• The device may interference or interfere with the radio or the
operation of the equipment nearby. If this happens, reduce
the interference by reorienting and repositioning the device or
screening off the immediate environment. The electromagnetic
radiation emitted from this device is below the recommended
limits specified by the applicable relevant provisions(EN 60601-
1-2:2007 & EN 60601-1:2006).
• The device requires special precautions with regard to
electromagnetic compatibility (EMC) and it must be installed
and operated in strict compliance with the EMC information.
Especially, do not use the device in the vicinity of fluorescent
lamps, radio transmitters, remote controls, portable or mobile
RF communication devices, even if they meet CISPR 8
requirements.
• Do not charge, operate or store the device at high
temperatures. Comply it with the specified operating and
storage conditions.
4.1. User
4.2. Ambient conditions
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The LEDEXTM WL-070 Dental Curing Light is an electric device
designed to meet the worldwide electrical safety standards, which
includes U.S.A and Europe, so it’s safe and effective for all dental
applications.
To avoid electric shock:
• Do not attempt to open or alter the unit in any way. Only the
service centers authorized by DENTMATE can open the unit
housing and repair the device.
• Do not put any foreign objects into the housing of the unit.
• Use only the LEDEXTM WL-070 power supply when recharging
this product. Never attempt to use any other devices for
recharging.
• Connect the power plug into a suitably grounded and approved
outlet. When you use an extend cable, make sure the grounded
line is not interrupted.
• Always unplug the charging dock before disinfecting.
• Never use the power supply if the cord has been damaged.
4.3. To avoid electric shock(shock hazard)
As it is the case with all high-performance lights, the high light
intensity results in a certain heat development. Prolonged
exposure near the pulp and soft tissues may result in irreversible
or reversible damage. Therefore,this high-performance curing light
must be operated by trained professionals.
4.4. Heat development (burn hazard)
Use only original spare parts, particularly DENTMATE batteries
and charging bases. Do not short circuit battery. Do not store at
temperatures above 40 °C / 104 °F(or 60 °C / 140 °F for a short
period). Always store batteries charged. The storage period must
not exceed 6 months. It may explode if it’s disposed of in fire.
4.5. Battery
Note : At least 10 mm gap between soft tissues and optical fiber
light guide rod.
10

Only use original DENTMATE components/accessories and spare
parts :
Original DENTMATE accessories DENTMATE REF
LEDEX™ WL-070 Handpiece 3100-1001
Holder 1230-0002
Power supply (input AC100~240 V, 50-60
Hz, output DC5 V/2 A) 2310-0010
Filter 2100-0006
Optical fiber light guide rod(Ø8 mm) 2402-0001
Anti-glare shield 1220-0004
Disposable light guide sleeve 2401-0001
Disposable curing light sleeve 2401-0003
Using other makes of accessories/spare parts can lead to
increased emission of electromagnetic interference or to reduced
electromagnetic interference immunity.
4.6. Accessories
4.7. Repairs and defects
Do not use the device if you suspect it is damage or defect.
4.8. Transport
Intact devices can be transported by land freight or air freight in
the original packaging. The applicable requirements must be met.
Defective devices can also be transported by air freight or land
freight in the original packaging. If the battery is defective, the
device won’t be able to be transported by air freight under any
circumstances.
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Problem Resolution
Can’t turn on the handpiece Please plug-in the power supply and charge the
battery. Then push the ON/OFF button again.
Please contact your qualified technician.
When the battery has malfunctioned and can’t be
charged, the Display will glow and show the sign of
“Er.” Please call your qualified technician to replace
it with a new battery.
This “OH” means the temperature is too high.
Please wait a moment and use it later.
The intensity is too low
If the result of the intensity test in Standard mode is
under 700 mW/cm2, it means the output is too low.
Please contact with your dealer.
6. Troubleshooting
5.1. During operation, the light should be aimed straightly on the resin to ensure
solidification effectively.
5.2. Never aim the light directly at unprotected soft tissues because it may lead to
injury or irritation. Do not aim the light at eyes. Light reflected from the tooth surface
may also injure eyes. Use the protective shield supplied with the unit or suitable
light filtering safety glasses.
5. Precaution
12

8. Disposal
Comply with your national regulations, guidelines and requirements for the disposal
of end-of-life electrical equipment and batteries. Specialized dental dealers will be
pleased to provide you with country-specific information concerning disposal.
This device is provided with a Li-ion battery. For environmental reasons,please
dispose of the device according to local environmental guidelines or regulations.
Make sure the product or the battery is not mixed with other types of waste when it
is disposed of. Prior to disassembly and disposal, your device has to be completely
reprocessed and must not be contaminated.
7. Daily Maintenance
Read this entire section before cleaning the unit. This product must be cleaned as
normal preparation for each patient to prevent cross infection.
The use of the sleeve is an additional precautionary measure against contamination
and does not substitute disinfection of the device.
After using, remove the sleeve. Clean the optical light guide rods and the handpiece
with a cloth mositure with alcohol or cleaner. Keep solvents or flammable liquids
from the unit because they may damage its plastic housing.
Always keep the charger, handpiece and light guide well. Moisture may cause
electrical short-circuit or dangerous malfunction.
9. Warranty
DENTMATE TECHNOLOGY Co., Ltd. warrants the product to be free of
manufacturing defects for a period of one year from the date of purchase; this
is deemed as the date of the invoice. It could be repaired or replaced at its own
discretion all equipment failures due to manufacturing defects. However,the
followings are expressly excluded from the warranty:
1. Damage and/or failure of the equipment caused by falling and/or jolting during
transportation after purchase and/or during the normal use.
2. Damage and/or failure of the equipment caused by natural disasters, such as
earthquakes, floods, lightning, pollution, incorrect electrical voltage and voltage
spikes.
3. Any attempts to open the hand piece will invalidate the warranty.
EN
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10. Product Specifications
Type of Information Specifications
Dental Curing Light Medical equipment
Device Name LEDEXTM
Model Number WL-070
Power supply Input: AC100~240 V, 50-60 Hz
Output: DC 5 V/2 A
Light source High power dental blue 5 W LED
The range of wavelength 440-480 nm, peak : 460 nm
Radiant intensity Up to 1000 mW/cm²
Hand piece dimensions Ø26 (max) x L156 mm
Hand piece weight 120 g (with battery & light guide rod)
Holder dimensions Ø80 x H25 mm (max)
Holder weight 70 g
Equipment class(AC Adapter) Class II
Safety IEC 60601-1
EMC(Electro-Magnetic Compliance) IEC 60601-1-2
Protection from electric shock Type B applied part
Protection from ingress of liquids IPX0
Operation Continuous operation patient application, duty
cycle 50 seconds ON /2 minute OFF.
Operating environment
Ambient temperature:
Relative humidity:
Atmospheric pressure:
Storage and Transport environment
Ambient temperature:
Relative humidity:
Atmospheric pressure:
75%
30% 1.0-atm
0.5-atm
10° C
40° C
50° F
104° F
106kPa
50kPa
95%
10% 1.0-atm
0.5-atm
10° C
40° C
50° F
104° F
106kPa
50kPa
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11. EMC Declaration Of Conformity
Important information regarding Electro Magnetic Compatibility (EMC) with
the increased number of electronic devices such as PC’s and mobile (cellular)
telephones,medical devices in use may be susceptible to electromagnetic
interference from other devices. Electromagnetic interference may result in
incorrect operation of the medical device and create a potentially unsafe
situation. Medical devices should not interfere with other devices, too. In order to
regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim
to prevent unsafe product situations, the EN60601-1-2:2007 standard has been
implemented. This standard defines the levels of immunity to electromagnetic
interferences as well as maximum levels of electromagnetic emissions for medical
devices.
This medical device manufactured by DENTMATE conforms to thisEN60601-
1-2:2007standard for both immunity and emissions. Nevertheless, special
precautions are needed to be observed:
• Do not use mobile (cellular) telephones and other devices which generate
strong electrical or electromagnetic fields near the medical device. This may
result in incorrect operation of the unit and create a potentially unsafe situation.
Keep a minimum distance of 7 m. Verify correct operation of the device in case
the distance is shorter.
Further documentation in accordance with EN60601-1-2:2007 is available within
this manual referring to section “Manufacturer’s Declaration”.
12. Manufacturer’s Declaration
The LEDEXTM WL-070 is intended for use in the electromagnetic environment
specified below. The customer or the user of the LEDEXTM WL-070 should assure
that it is used in such an environment.
Electromagnetic Emissions: (IEC60601-1-2)
Emission Test Compliance Electromagnetic Environment
RF emission
CISPR 11 Group 1
The LEDEXTM WL-070 uses RF energy
only for internal functions. Therefore, this
RF emission is extremely weak and there
is little chance of it creating any kind
of interference whatsoever with nearby
electronic equipment.
RF emissions
CISPR 11 Class A
Harmonic emissions
IEC 61000-3-2 Class B
The LEDEXTM WL-070 is suitable for use
in all establishments, including domestic
establishments and those directly
connected to the public low voltage
power supply network that supplies
buildings used for domestic purposes.
Voltage fluctuations/
flicker
IEC 61000-3-3
Complies
EN
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(IEC60601-1-2)Electromagnetic Immunity:
Immunity test IEC60601-1-2
test level
Compliance
level
Electromagnetic
environment-guidance
Electrostatic
discharge
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electric fast
transient/burst
IEC 61000-4-4
±2kV for
power supply
lines
±1kV for input/
output lines
±2kV for
power supply
lines
±1kV for input/
output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV
differential
mode
±2 kV
common mode
±1 kV
differential
mode
±2 kV
common mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5 % UT
for 0.5 cycle
<5 % UT
for 0.5 cycle Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the LEDEXTM WL-070 requires
continued operation during
power mains interruptions, it is
recommended that the LEDEXTM
WL-070 be powered from an
uninterruptible power supply or a
battery.
40% UT
for 0.5 cycle
40% UT
for 0.5 cycle
70% UT
for 0.5 cycle
70% UT
for 0.5 cycle
<5 % UT
for 5 sec.
<5 % UT
for 5 sec.
Power
frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
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