Guilin Woodpecker Medical Instrument LED.Q User manual

Content
1. Introduction .................................................................1
2. Structure and components ..........................................2
3. Technical specications ..............................................2
4. Install and uninstall way .............................................4
5. Operation .....................................................................4
6. Cleaning, Disinfection and Sterilization......................6
7. Precaution .................................................................15
8. Contraindication ........................................................16
9. Maintenance ..............................................................16
10.Trouble shooting ......................................................17
11. Storage and transportation ......................................17
12. After-sale service .....................................................18
13. Environmental protection .......................................18
14. Symbol instruction ..................................................19
15. Manufacturer’s right ..............................................20

1
1. Introduction
1.1 Foreword
Guilin Woodpecker Medical Instrument Co., Ltd. is a
high-tech enterprise in researching, developing, and
producing dental equipment, and has a perfect quality
assurance system. Main products include periodontal
treatment device, ultrasonic scaler, curing light, high
speed turbine handpiece, apex locator and ultrasurgery etc.
1.2 Feature:
A) Sealed, connect to dental unit.
B) Time setting: 10s, 20s, 30s.
C) Working mode: Full.
1.3 Principle and usage
1.3.1 LED.Q adopts the principle of ray radiation to
solidify the light-sensitive resin by shooting at it in a short
time.
1.3.2 This product is used to restore teeth and solidify
material for whitening teeth.

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2. Structure and components
LED.Q is composed mainly of main unit, optical fiber,
light hood, high power LED and cable. (Picture 1)
3. Technical specications
3.1 Dimensions: 248mm×26mm×26.5mm
3.2 Net weight: 127g
3.3 Conguration:
Main unit *1 Optical ber *1

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Light hood *1 Instruction book *1
Product certicate *1 Warranty card *1
3.4 Power supply
3.4.1 According to the classication of power supply
Connect to dental unit ~24V
3.4.2 Power input: ~24V 50Hz/60Hz 0.4A Max
3.5 Light source
3.5.1 3W high power blue LED light
3.5.2 Wave length: 420nm-480nm
3.5.3 Light intensity: 1000mW/cm2~1200mW/cm2
3.5.4 Category: 1
3.5.5 Launch limit(AEL): 3.9×10-3J
3.5.6 Inspection method: If the LED light shines when
operate correctly, it's in good condition.
3.5.7 Clinical commonly used resin can match with the
wavelength, such as 3M, Dentsply etc.
3.6 Radiation during 400nm~515nm(blue light):
≧250mW/cm2
3.7 Optical active area: 50mm2
3.8 Working condition:
3.8.1 Environment temperature: 5℃to 40℃
3.8.2 Relative humidity: 30%~75%
3.8.3 Atmosphere pressure: 70kPa to 106kPa

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3.9 Protection type against electrical shock: classⅡ
3.10 Protection against electrical shock: type B
3.11 Protection against harmful ingress of water or
particular matter: ordinary equipment (IPX0)
3.12 Safety in the presence of flammable anesthetic
mixture with air, oxygen or nitrous oxide: not suitable
under this condition.
4. Install and uninstall way
4.1 Connect the LED power supply line with the power
(24V~) of dental unit. Tight the nylon thread to the
fixation of the dental unit, then it will be available for
operation.
Notice: When installing the LED, be sure the power
is cut o. The two power wires should be a little longer
than the nylon thread to keep the power wire safe.
4.2 Take o the red cap from the optical ber and insert
the metal part into the front of the built-in LED.Q (Make
sure to screw the ber to the end by rotating it).
4.3 Install the light hood as shown in picture 1.
5. Operation
5.1 Press the button to turn on the device.

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5.2 After turning on the device, keep pressing the button
in 1second, then the indicator light scroll shines. Now you
can choose 10s, 20s, and 30sworking time.
5.3 While operating, put the light source alignment the
position where needs to be solid, press the button in a
short time, then with a “Di” voice, the main unit shines
blue light and starts the countdown. When countdown
back to 0, the main unit stops working, and with a long
“Di” voice, the indicator light comes back to the setting
time.
5.4 It can be stopped working at any time by short
pressing the button while operating.
5.5 At the end of a working cycle, the next working cycle
can be started immediately by short pressing the button. If
the main unit gets hot obviously, please turn o the device
until the main unit becomes cool.
Please don’t make it continuously illuminate more than
10times.
5.6 If there is resin on the ber after using, please clear it
by cotton cloth to make sure the power intensity is good.
5.7 The device will turn o after 2 minutes idle.
5.8 This device can cure composite resin not less than
4mm in 10 seconds.

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6. 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 pro ducts 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.
6.1 Initial processing
6.1.1 Processing principles
It is only possible to carry out eective sterilization after
the completion of effective 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

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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.
6.1.2 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 fiber 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.
6.2 Preparation before cleaning
Steps
Tools: tray, soft brush, clean and dry soft cloth Remove
optical ber 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 fiber and put them into a clean tray.
The cleaning agent can be pure water, distilled water or
deionized water.

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6.3 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.
6.3.1 Automated cleaning
•The cleaner is proved to be valid by CE certificationin
accordance with ENISO 15883.
▪There should be a flushing 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”.
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.

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6.4 Disinfection
Disinfection must be performed no later than 2 hours after
the cleaning phase.
Automated disinfection is preferred if conditions permit.
6.4.1 Automated disinfection-Washer-disinfector
·The washer-disinfector is proved to be valid by CE
certication in accordance with EN ISO 15883.
·Use high temperature disinfection function. The
temperature does not exceed 134 ° C, 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”).

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Notes
a) Before use, you must carefully read the operating
instructions 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

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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.
6.5 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
flat table, point the 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.

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6.6 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.
6.6.1 Check the product. If there is still visible stain on
the product after cleaning/disinfection, the entire cleaning/
disinfection process must be repeated.
6.6.2 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.
6.6.3 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.
6.6.4 If the service time (number of times) of the product
reaches the specied service life (number of times), please
replace it in time.
6.7 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 regularly to ensure cleanliness and prevent the

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introduction of contaminants;
d) Avoid contact with parts of different metals when
packaging.
6.8 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
certified 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 effectively 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;

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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.
6.9 Storage
6.9.1 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;
6.9.2 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.

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6.10 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.
7. Precaution
7.1 Optical ber is fragile glass, do not knock, collide it or
let it fall.
7.2 During operation the light should be aimed straightly
on the resin, to ensure solidication eectively.
7.3 Be sure to use the original light hood, and make sure
to install it in correct way to avoid the blue light hurt eyes.
Strictly prohibit aiming light at eyes directly.

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8. Contraindication
The heart disease patients, pregnant women and children
should be cautious to use this equipment.
9. Maintenance
9.1 This product does include repair part, machine
maintenance and repair shall be made by the designated
professional or repaired at a repair shop.
9.2 Users can replace light hood and optical ber on hand.
Besure to use the original accessories. Please contact with
the local dealer or the company. Banning the use of other
related accessories, lest cause curing light damage or other
dangerous.
9.3
The optical ber should be sterilized for 4 minutes with 134℃and
2.0bar~2.3bar (0.20MPa~0.23MPa) before each use
.
9.4 After operation each time, please shut o the power
source and clean the optical ber.

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10.Trouble shooting
Faulty Possible cause Solution
No-
indication
Non-act.
1, Continuous use time
is too long, thermal
protection circuit
working.
2, The device is not
connected well with
power.
3, main unit broken.
1, Wait for a few
minutes, it will be
back to normal.
2,Check the
connection of the
device and the
power.
3, Contact the
local dealer or us.
Light
intensity
insucient.
1, Optical ber isn't
inserted well to the
bottom.
2, The optical ber iss
cracked.
3, There is resin remain
on the surface of the
optical ber.
1, Install the
optical ber well.
2, Change the
optical ber.
3, Remove the
resin.
If all the above solutions have been completed, the
machine still can not work normally. Please contact our
special repair shop or us.
11. Storage and transportation
11.1 This equipment should be handled carefully, kept

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away from shaking point, installed or stored at shadowy,
dry, cool and ventilated places.
11.2 Don't store it together with articles that are
combustible, poisonous, caustic and explosive.
11.3 This equipment should be stored in a room where the
relative humidity is 10%~93%, atmospheric pressure is
70kPa to106kPa, and the temperature is -20℃to +55℃.
11.4 Excess impact or shake should be avoided during
transportation.
11.5 Don't mix it with dangerous articles during
transportation.
11.6 Keep it away from sun or snow or rain during
transportation.
12. After-sale service
From the date of this equipment sold, if the equipment
can’t work normally because of the quality problems, our
company will be responsible for the maintenance base
on the warranty card. Please refer the warranty scope and
period from warranty card.
13. Environmental protection
Please dispose according to the local laws.