Woodpeckers LED.D User manual

LED.D Curing light Instruction Manual

LED.D Curing light Instruction Manual
Content
1.Principle and usage .............................................................. 1
2. Structure and components ................................................. 1
3. Technical specications ....................................................... 2
4. Contraindication ................................................................. 3
5. Cleaning , Disinfection and Sterilization ........................... 3
6. Cautions ............................................................................... 9
7. Installation ......................................................................... 11
8. Operation ........................................................................... 11
9. Maintenance ...................................................................... 13
10. Transportation ................................................................. 13
11. Storage and transportation ............................................ 14
12. Trouble shooting .............................................................. 14
13. Packing list ....................................................................... 15
14. Environment protection ................................................. 15
15. After service ..................................................................... 16
16. European authorized representative ............................. 16
17. Symbol instructions ........................................................ 16
18.Statement .......................................................................... 17
19. EMC - Declaration of conformity................................... 18

1.Principle and usage
1.1 LED.D adopts the principle of ray radiation to solidify the light-
sensitive resin by shooting at it in a short time.
1.2 This product is used for dentistry. It has the function of accelerating
dental restoration and solidifying the material of dental whitening.
2. Structure and components
LED.D curing light (dentistry) is mainly composed by high power LED,
optical fiber, and main unit. Figure 1 shows the main components of
LED.D.
Figure 1

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3. Technical specications
3.1 Power supply:
3.1.1 Rechargeable Lithium battery:
Battery model: ICR18490
Battery voltage and capacity: 3.6V, 1400mAh
The battery includes over-voltage protection, over-current protection
and short circuit protection.
3.1.2 Adapter:
Input: AC100V-240V 50Hz/60Hz
Output: DC5.0V/1A
3.2 Applied part: Optical ber
3.3 Light source:
3.3.1 3W high power blue light LED
3.3.2 Wave length: 385nm-515nm
3.3.3 Light intensity: 1000mW/cm2~1700mW/cm2
3.4 Work condition:
3.4.1 Environment temperature: +5℃~+40℃
3.4.2 Relative humidity: 30%~75%
3.4.3Atmosphere pressure: 70kPa to106kPa
3.5 Size: 202mm×32mm×38mm
3.6 Net weight: 143g
3.7 Consume power: ≤8W
3.8 Protection type against electrical shock: class II
3.9 Protection degree against electrical shock: type B
3.10 Protection against harmful ingress of water or particular matter:
ordinary equipment (IPX0), not water protected.
3.11 Safety in the presence of flammable anesthetic mixture with air-
oxygen or nitrous oxide: not suitable under this condition.
3.12 Equipment for operation in the room
3.13 Non-continuously work instrument: after work 200 seconds, stop 60
seconds, and then work 40 seconds, stop 60 seconds, work in the rule as
above circularly.

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4. Contraindication
Heart disease patients, pregnant women and children should be cautious
to use this equipment.
5. Cleaning , Disinfection and Sterilization
The cleaning, disinfection and sterilization of optical ber is as follow.
Unless otherwise stated, they will be hereinafter referred to as “products”.
Warnings
The use of strong detergent and disinfectant (alkaline pH>9 or acid
pH <5) will reduce the life span of products. And in such cases, the
manufacturer takes no responsibility.
This device shall not be exposed to high temperature above 138℃.
Processing limit
The products have been designed for a large number of sterilization
cycles.
The materials used in manufacture were selected accordingly. However
with every renewed preparation for use, thermal and chemical stresses
will result in ageing of the products. The maximum number of
sterilizations for optical ber is 500 times.
5.1 Initial processing
5.1.1 Processing principles
It is only possible to carry out eective sterilization after the completion
of eective cleaning and disinfection. Please ensure that, as part of your
responsibility for the sterility of products during use, only suciently
validated equipment and product-specific procedures are used for
cleaning/disinfection and sterilization, and that the validated parameters
are adhered to during every cycle.
Please also observe the applicable legal requirements in your country as
well as the hygiene regulations of the hospital or clinic,especially with
regard to the additional requirements for the inactivation of prions.

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5.1.2 Post-operative treatment
The post-operative treatment must be carried out immediately, no later
than 30 minutes after the completion of the operation. The steps are as
follows:
1. Remove the optical ber from the Curing light Device,and rinse away
the dirt on the surface of product with pure water (or distilled water/
deionized water);
2. Dry the product with a clean, soft cloth and place it in a clean tray.
Notes
a) The water used here must be pure water, distilled water or deionized
water.
5.2 Preparation before cleaning
Steps
Tools: tray, soft brush, clean and dry soft cloth Remove optical fiber
from main unit and put it into the clean tray.
Use a clean soft brush to carefully brush the optical ber until the dirt
on surface is not visible. Then use soft cloth to dry the optical ber and
put them into a clean tray. The cleaning agent can be pure water, distilled
water or deionized water.
5.3 Cleaning
The cleaning should be performed no later than 24 hours after the
operation.
The cleaning can be divided into automated cleaning and manual
cleaning. Automated cleaning is preferred if conditions permit.
5.3.1 Automated cleaning
•The cleaner is proved to be valid by CE certicationin accordance with
ENISO 15883.
▪There should be a ushing connector connected to the inner cavity of
the product.
▪The cleaning procedure is suitable for the product, and the irrigating
period is sucient.
It is recommended to use a washer-disinfector in accordance with EN
ISO15883. For the specific procedure, please refer to the automated
disinfection section in the next section “Disinfection”.

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Notes
a) The cleaning agent does not have to be pure water. It can be distilled
water, deionized water or multi-enzyme. But please ensure that the
selected cleaning agent is compatible with the product.
b) In washing stage, the water temperature should not exceed 45 °C,
otherwise the protein will solidify and it would be dicult to remove.
c) After cleaning, the chemical residue should be less than 10mg / L.
5.4 Disinfection
Disinfection must be performed no later than 2 hours after the cleaning
phase.
Automated disinfection is preferred if conditions permit.
5.4.1 Automated disinfection-Washer-disinfector
·The washer-disinfector is proved to be valid by CE certification in
accordance with EN ISO 15883..
·Use high temperature disinfection function. The temperature does not
exceed 134 ℃, and the disinfection under the temperature cannot exceed
20 minutes.
·The disinfection cycle is in accordance with the disinfection cycle in
EN ISO 15883.
Cleaning and disinfecting steps by using Washer-disinfector
1. Carefully place the product into the disinfection basket. Fixation of
product is needed only when the product is removable in the device. The
products are not allowed to contact each other.
2. Use a suitable rinsing adaptor, and connect the internal water lines to
the rinsing connection of the washer-disinfector.
3. Start the program.
4. After the program is nished, remove the product from the washer-
disinfector,
inspect (refer to section “Inspection and Maintenance”) and packaging
(refer to chapter “Packaging”). Dry the product repeatedly if necessary
(refer to section “Drying”).
Notes
a) Before use, you must carefully read the operating instructions

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provided by the equipment manufacturer to familiarize yourself with the
disinfection process and precautions.
b) With this equipment, cleaning, disinfection and drying will be carried
out together.
c) Cleaning: (c1) The cleaning procedure should be suitable for the
product to be treated. The flushing period should be sufficient (5-10
minutes). Pre-wash for 3minutes, wash for another 5 minutes, and rinse it
for twice with each rinse lasting for 1 minute. (c2) In the washing stage,
the water temperature should not exceed 45 °C, otherwise the protein
will solidify and it is dicult to remove. (c3) The solution used can be
pure water, distilled water, deionized water or multi-enzyme solution,
etc., and only freshly prepared solutions can be used. (c4)During the use
of cleaner, the concentration and time provided by manufacturer shall be
obeyed.
The used cleaner is neodisher MediZym (Dr. Weigert).
d) Disinfection: (d1) Direct use after disinfection: temperature ≥ 90 ° C,
time ≥ 5 min or A0 ≥ 3000.
(d2)Sterilize it after disinfection and use: temperature ≥ 90 ° C, time ≥ 1
min or A0 ≥ 600.
(d3) For the disinfection here, the temperature is 93 ° C, the time is 2.5
min, and A0>3000.
e) Only distilled or deionized water with a small amount of
microorganisms (<10 cfu/ml) can be used for all rinsing steps.
(For example, pure water that is in accordance with the European
Pharmacopoeia or the United States Pharmacopoeia).
f) After cleaning, the chemical residue should be less than 10mg / L.
g)The air used for drying must be ltered by HEPA.
h) Regularly repair and inspect the disinfector.
5.5 Drying
If your cleaning and disinfection process does not have an automatic
drying function, dry it after cleaning and disinfection.
Methods
1. Spread a clean white paper (white cloth) on the at table, point the

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product against the white paper (white cloth), and then dry the product
with filtered dry compressed air (maximum pressure 3 bar). Until no
liquid is sprayed onto the white paper (white cloth), the product drying is
completed.
2. It can also be dried directly in a medical drying cabinet (or oven). The
recommended drying temperature is 80℃~120℃ and the time should be
15~40 minutes.
Notes
a) The drying of product must be performed in a clean place.
b) The drying temperature should not exceed 138 °C;
c) The equipment used should be inspected and maintained regularly.
5.6 Inspection and maintenance
In this chapter, we only check the appearance of the product. After
inspection, if there is no problem, the optical ber can only be used.
5.6.1 Check the product. If there is still visible stain on the product after
cleaning/disinfection, the entire cleaning/disinfection process must be
repeated.
5.6.2 Check the product. If it is obviously damaged, smashed, detached,
corroded or bent, it must be scrapped and not allowed to continue to be
used.
5.6.3 Check the product. If the accessories are found to be damaged,
please replace it before use. And the new accessories for replacement
must be cleaned, disinfected and dried.
5.6.4 If the service time (number of times) of the product reaches the
specied service life (number of times), please replace it in time.
5.7 Packaging
Install the disinfected and dried product and quickly package it in a
medical sterilization bag (or special holder, sterile box).
Notes
a) The package used conforms to ISO 11607;
b) It can withstand high temperature of 138 °C and has sucient steam
permeability;
c) The packaging environment and related tools must be cleaned

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regularly to ensure cleanliness and prevent the introduction of
contaminants;
d) Avoid contact with parts of dierent metals when packaging.
5.8 Sterilization
Use only the following steam sterilization procedures (fractional pre-
vacuum procedure*) for sterilization, and other sterilization procedures
are prohibited:
1. The steam sterilizer complies with EN13060 or is certied according
to EN 285 to comply with EN ISO 17665;
2. The highest sterilization temperature is 138 ° C;
3. The sterilization time is at least 4 minutes at a temperature of
132℃/134℃ and a pressure of 2.0 bar ~ 2.3 bars.
4. Allow a maximum sterilization time of 20 minutes at 134 °C.
Verication of the fundamental suitability of the products for eective
steam sterilization was provided by a veried testing laboratory.
Notes
a) Only products that have been eectively cleaned and disinfected are
allowed to be sterilized;
b) Before using the sterilizer for sterilization, read the Instruction Manual
provided by the equipment manufacturer and follow the instructions.
c) Do not use hot air sterilization and radiation sterilization as this may
result in damage to the product;
d) Please use the recommended sterilization procedures for sterilization.
It is not recommended to sterilize with other sterilization procedures
such as ethylene oxide, formaldehyde and low temperature plasma
sterilization. The manufacturer assumes no responsibility for the
procedures that have not been recommended.
If you use the sterilization procedures that have not been recommended,
please adhere to related eective standards and verify the suitability and
eectiveness.
* Fractional pre-vacuum procedure = steam sterilization with repetitive
pre-vacuum. The procedure used here is to perform steam sterilization
through three pre-vacuums.

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5.9 Storage
5.9.1 Store in a clean, dry, ventilated, non-corrosive atmosphere with a
relative humidity of 10% to 93%, an atmospheric pressure of 70KPa to
106KPa, and a temperature of -20 °C to +55 °C;
5.9.2 After sterilization,the product should be packaged in a medical
sterilization bag or a clean sealing container, and stored in a special
storage cabinet. The storage time should not exceed 7 days. If it is
exceeded, it should be reprocessed before use.
Notes:
a) The storage environment should be clean and must be disinfected
regularly;
b) Product storage must be batched and marked and recorded.
5.10 Transportation
1. Prevent excessive shock and vibration during transportation, and
handle with care;
2. It should not be mixed with dangerous goodsduring transportation.
3. Avoid exposure to sun or rain or snow during transportation.
The cleaning and disinfection of main unit are as follows.
• Before each use, wipe the surface of the machine with a soft cloth or
paper towel soaked in 75% medical alcohol. Repeat the wipe for at least
3 times.
• After each use, wipe the surface of the device with a soft cloth soaked
in clean water (distilled or deionized water) or a clean disposable wipe.
Repeat the wipe for at least 3 times.
6. Cautions
6.1 Please recharge the battery at least 4 hours before rst time usage.
6.2 Before operation, please read this instruction carefully. Please make
sure the user has the general knowledge of dental restoration, dental
treatment and dental whitening. The basic operate technique is also
needed for user.
6.3 During operation, the light should be aimed straightly at the

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composite resin to ensure the eect of solidication.
6.4 Avoid direct irradiation to the eye with the blue light.
6.5 Only the original pedestal charger, adapter and Lithium battery could
be used, because other brand pedestal charger, adapter and Lithium
battery are likely to damage the circuit.
6.6 In order to avoid damaging the circuit of charge or the battery, it is
forbidden to touch the charging connector with metal or other conductor.
6.7 Please charge the battery in the condition of cool and ventilated.
6.8 Do not disassemble the battery, it will lead to a circuit short and the
electrolyte leakage.
6.9 Do not squeeze or shake the battery, do not store the battery with
metal material.
6.10 If this equipment is not going to be used for a long time, please take
the battery out and preserve separately.
6.11 This equipment may cause the electromagnetic interference.
Please don't use it on the patients with pacemaker or on an E-Surgery.
Please be caution to use this equipment under the condition of strong
electromagnetic interference.
6.12 It is forbidden to disassemble the equipment. We shall not assume
any responsibility for any malfunction, damage or accident caused by
disassembling the equipment.
6.13 It is forbidden to modify the equipment. We shall not assume
any responsibility for any malfunction, damage or accident caused
by improper removal, modification, maintenance, or repair with
device components not supplied by the manufacture or our authorized
representative.
6.14 The optical fiber is reusable. Please make sure they are autoclaved
under high pressure and high temperature before each operation.
① WARNING: If the curing light works for 40s continously,the
temperature of the top of optical ber may reach 56℃.
② “WARNING: Do not modify this equipment without authorization

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of the manufacturer.
7. Installation
7.1 Take o the red cap from the optical ber, and then insert the metal
part into the front of main unit (make sure to screw the ber to the end).
7.2 Fix the light hood on the bottom of the optical ber.
7.3 Battery replacement method: open the battery cover of the main unit,
take the battery out, and disconnect the plug slightly. Connect the plug of
the new battery correctly (Figure 2), put the new battery in, and then x
the battery cover.
7.4 Charge method: For Charging, please pull out the charge port
protector of the main unit slightly, plug the output port of the adapter
into the charge port of the main unit, and then connect the adapter to the
power supply. When charging is nished, pull out the adapter and plug
the protector back into the charge port of the main unit.
Notice: Don't x the adapter at where the operation can’t be taken
place easily.
8. Operation
8.1 Press the mode button to set the working mode, the corresponding

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indicator will be on when a mode is set.
8.1.1 Full power: the blue light radiates in full power.
8.1.2 Ramping mode: the blue light power increase stronger continually
and gets to the highest power 5 seconds later.
8.1.3 Pulse mode: the blue light works on the pulse condition.
8.2 Press the time button to set the solidifying time, 8 working times are
available: 5, 10, 15, 20, 25, 30, 35, 40 seconds.
8.2.1 Select 5 seconds: the blue light will shine at 1500 mw/
cm²~1700mw/cm².
8.2.2 Select 10, 15 , 20, 25, 30, 35 and 40 seconds: the blue light will
shine at 1000mw/cm²~1200mw/cm² .
8.3 When operating, aim the optical ber at the correct position, press
the power button to start or stop emitting of the blue light.
8.4 During the operation, the blue light can be stopped by press the
power button at any time.
8.5 A battery detect circuit is xed inside the main unit, when low power
is detected, the indicator of the main unit will wink, please charge in
time.
8.6 The mode indictor will be enlightened one by one when charging.
They will all be enlightened if charging has nished. If a battery error is
detected, the indicator of the mode will wink.
8.7 When the equipment is charging, it is possible to turn the equipment
into the normal work state by pressing any button. If the button is not
pressed within 10 seconds, the equipment will turn back into charge
state.
8.8 If the charge is not finished, when the working condition changes
from normal mode to sleep mode, the equipment will turn into charge
state automatically.
8.9 The equipment still can be used for a while after a low power alarm,
but with a lower light intensity. And then the equipment will turn into
the protect mode that all functions will be locked until the machine is
connected to the power supply or the battery is replaced.
8.10 When operation is nished, please clean the optical ber with calico

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in order not to aect the light intensity.
8.11 This equipment will be off automatically if no action occurred
within 2 minutes. Turn it on by pressing any button.
8.12 The eective light intensity of this equipment is much higher than
halogen lamp curing light. The solidied depth of the composite resin is
no less than 4mm if irradiated by this equipment for 10 seconds.
8.13 The optical ber should be sterilized for 4 minutes with 134℃and
2.0bar~2.3bar (0.20MPa~0.23MPa) before each use.
8.14 The curing light is equipped with over-heat protection system. It
can continuously work 200s, For example, continuously operate the
curing light for 10 times under 20s working mode (even the curing light
works less than 20s, it is counted as a full operation), then it will come
into over-heat protection status. And only after 2-minute sleep, it can
restart working 200s continuously.
9. Maintenance
9.1 This equipment does not include the self-maintenance parts, so it
should be performed by professional or special maintenance shop.
9.2 The optical ber should be sterilized for 4 minutes with 134℃and
2.0bar~2.3bar (0.20MPa~0.23MPa) before each use, other parts should
be cleaned by clean water or neutral sterilized liquid, but do not soak
the equipment in the water. Do not clean by volatile or soluble liquid,
otherwise the marks of the control panel will fade.
9.3 Please clean the optical fiber to avoid the remaining resin on the
surface and infect the life-span and the eectiveness of solidication.
10. Transportation
10.1 Excessive impact and shake should be prevented in transportation.
Lay it carefully and lightly and don't invert it.
10.2 Don't put it together with dangerous goods during transportation.

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10.3 Avoid solarization and getting wet in rain or snow during
transportation.
11. Storage and transportation
11.1 The equipment should be handled carefully and lightly, kept away
from the shaking source, installed or stored at shadowy, dry, cool and
ventilated places.
11.2 Don't store the equipment together with articles that are
combustible, poisonous, caustic, and explosive.
11.3 This equipment should be stored in the environment where the
humidity is 10%~93%, the atmosphere pressure is 70kPa~106kPa and
the temperature is -20℃~55℃.
11.4 Excess impact or shake should be prevented during transportation.
Handle with care. Do not place upside down.
11.5 Don't put it together with dangerous articles during transportation.
11.6 Keep it away from the sun, rain or snow during transportation.
12. Trouble shooting
Faulty Possible cause Solutions
No indication, no
response.
1. Battery is out of power.
2. Faulty of battery.
1. Charge the equipment/
Change a new batter.
2. Change a new battery
“Er” shown on the screen. Faulty of main unit. Send to after service for
repair.

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Faulty Possible cause Solutions
“EA”is blinking shown on
the screen, and the buzzer
rings continuously.
Have used faulty adapter
with excessive output.
Change to the original
adapter with output of
5V/1A
“E1” shown on the screen. Low battery.
Reconnect the charger, if
”E1” show again
after 15 minutes please
change the battery.
The equipment is not
charging when the adapter
is connected.
1. The adapter is not
connected well.
2. Faulty of adapter or
incompatible.
3.The charging point is
impurity.
1. Reconnect.
2. Change the adapter.
3. Cleaned by the alcoho.
Light intensity is weak.
1. The optical ber is not
installed well.
2. There is crevice on the
optical ber.
3. There is resin on the tip
of the optical ber.
1. Reinstall the optical
ber.
2. Change a new optical
ber.
3. Clear the resin.
Effective duration of the
battery become short.
The capacity of the battery
decreased. Change a new battery.
The mode indicator
twinkles when charging.
1. Low voltage.
2. Short-circuit of the
battery.
1. Back to normal after 15
minuets charging.
2. Change a new battery.
If the problem still can’t be solved, please contact with local dealer or
manufacurer.
13. Packing list
The components of the equipment are listed in the packing list.
14. Environment protection

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Please dispose according to the local laws.
15. After service
From the date this equipment has been sold, we oer two year free repair
to the equipment if it has quality problems, please refer to the warranty
card for the warranty period.
16. European authorized representative
17. Symbol instructions
Trademark CE marked product
Type B applied part Screw inside/ outside
Ordinary equipment Class II equipment
Date of manufacture Alternating current
Manufacturer Recovery

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Used indoor only Keep dry
Handle with care
Sterilizable up to the temperature specied
Temperature limitation for storage
Humidity limitation for storage
Atmospheric pressure for storage
Appliance compliance WEEE directive
Follow Instructions for Use
Authorised Representative in the EUROPEAN COMMUNITY
18.Statement
All rights of modifying the product are reserved to the manufacturer
without further notice. The pictures are only for reference. The final
interpretation rights belong to GUILIN WOODPECKER MEDICAL

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INSTRUMENT CO., LTD. The industrial design, inner structure, etc,
have claimed for several patents by WOODPECKER, any copy or fake
product must take legal responsibilities.
19. EMC - Declaration of conformity
The device has been tested and homologated in accordance with EN
60601-1-2 for EMC. This does not guarantee in any way that this device
will not be effected by electromagnetic interference Avoid using the
device in high electromagnetic environment.