B.A. International BA-OPTIMA 10 User manual

BA OPTIMA 10
CURING LIGHT
BASES10 / BLACK
BASES20 / BLUE
BASES30 / RED
BASES40 / GREEN
BASES50 / GREY
BASES60 / PINK
BASES70 / PURPLE
BASES80 / JADE GREEN
INSTRUCTIONS FOR USE
MODO DE EMPLEO
MANUEL D’UTILISATION
GEBRAUCHSANWEISUNG
ISTRUZIONI PER L’USO
GEBRUIKSAANWIJZING

Content
1 Principle and usage ...............................................................1
2 Structure and component .....................................................1
3 Technical specications .........................................................2
4 Installment and dismantlement ...........................................3
5 Operation ...............................................................................3
6. Cleaning, Disinfection and Sterilization .............................5
7 Cautions ...............................................................................14
8 Contraindication .................................................................15
9 Maintenance ........................................................................16
10 Troubleshooting .................................................................16
11 After service .......................................................................17
12 Storage and transportation ..............................................18
13 Environmental protection ................................................18
14 Representative in Europe .................................................18
15 Symbol instructions ..........................................................19
16 Statement ...........................................................................20
17 EMC - Declaration of conformity.....................................20
INSTRUCTIONS FOR USE

1
1 Principle and usage
1.1 BA Optima 10 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 to restore teeth in a dental environment by
trained professionals only.
2 Structure and component
BA Optima 10 (dental) is composed mainly of high power LED, optical
ber and main unit.
Figure 1-Ⅰ
Optical bre
Light hood
ON/OFF button
Display screen
Mode button
Time button
Battery compartment
Charger
Charger indicator
The following items must
be included in the package:
• Curing device
• Optical ber (BASES05)
• Battery (BAOPT004)
• Charger
• Light hood (BAOPT010)
• Power adaptor
• Instruction manual

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Figure 1-Ⅱ
3 Technical specications
3.1 Power supply: rechargeable Lithium battery
Battery model: ICR18650
Battery voltage and capacity: 3.7V/2200mAh
Input of adapter: AC100V to 240V, 50Hz/60Hz
Output of adapter: DC5V/1A
3.2 Applied part: optical ber
3.3 Light source:
a) 5W high power blue LED
b) Wave length: 420nm-480nm
c) Light intensity: 1000mW/cm2~1200mW/cm2
3.4 Working condition:
a) Environment temperature: 5℃to 40℃
b) Relative humidity: 30%~75%
c) Atmosphere pressure: 70kPa to 106kPa
Charger
Adapter
Socket for
power supply

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3.5 Dimensions: Φ25mm×252mm
3.6 Net weight: 152g
3.7 Consumption power: ≤8W
3.8 Protection type against electrical shock: classⅡ
3.9 Protection against electrical shock: type B
3.10 Protection against harmful ingress of water or particular matter:
ordinary equipment (IPX0)
3.11 Safety in the presence of flammable anesthetic mixture with air,
oxygen or nitrous oxide: not suitable under this condition.
4 Installment and dismantlement
4.1 Take o the red cap from the optical ber and then insert the metal
part into the front of the BA Optima 10, make sure to screw the ber to
the end.
4.2 Install the light hood on the top of the optical ber.
4.3 For dismantlement, follow the instruction of installment above in
reverse.
4.4 When nishing using or when the battery needs to be charged, plug
the output port of the adapter into the charge port, than connect the
adapter to the power supply. After that, place the device into the socket
on the charger.
5 Operation
5.1 Lightly press the mode key. Following three modes are available.

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5.1.1 Full power mode: screen shows 01, LED works in full power.
5.1.2 Ramping mode: screen shows 02, LED turns from weak to
stronger, and reaches the highest power in 5 seconds.
5.1.3 Pulse mode: screen shows 03, LED works in the mode of pulse.
5.2 Lightly press the time button to choose the solidification time. 9
working time modes are available: 3,5,10,15,20,25,30,35,40 seconds.
5.3 During the operation, aim blue light at the position needing
solidication. Press the ON/OFF switch, a “beep” sound will occur, the
LED starts to work under the selected mode. Then it counts down to “0”
second to end the solidication.
5.4 During operation, the blue light can be stopped by press the power
button at any time.
5.5 Low power detect circuit is xed inside of the main unit, when low
power is detected, the indicator of the main unit will wink, please charge
in time.
5.6 When the battery needs to be charged, connect the plug of the adapter
into the AC100V~240V power supply. Then connect the output plug
of the adapter to the input plug of the pedestal, and then the indicator
turn to green, that means the pedestal is standby. Put the main unit to
the charging point of the pedestal, the indicator turn to yellow, and the
curing lights starts charging. When charging is finished the indicator
turns green.
5.7 After the operation, please clean the ber with calico in order not to

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aect the light intensity.
5.8 This equipment will turn o automatically if no any action within 2
minutes, turn it on by press any button.
5.9 The depth of solidication of composite is no less than 4mm per 10
seconds.
5.10 The optical ber should be sterilized for 4 minutes with 134℃and
2.0bar~2.3bar (0.20MPa~0.23MPa) before each use.
5.11 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.
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

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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.
6.1 Initial processing
6.1.1 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.
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 ber from the Curing light Device,and rinse away
the dirt on the surface of product with pure water (or distilled water/
deionized water);

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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 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.
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 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.

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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.
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 certification 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

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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
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). (c2) Pre-wash for 3minutes, then wash the dirt for another
5 minutes (at least) with pure water at room temperature of 25 °C (or
distilled water/deionised water). (c3) Clean with mild alkaline cleaner at
the condition, concentration and time recommended by the manufacture
of the cleaning agent. Only freshly prepared solutions can be used. (The
used cleaning agent for the cleaning validation was

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RUHOF ENDOZIMER® AW PLUS WITH APA at dilution ratio: 1:270,
Temperature: ˂60°C and contact time: 5 mins). C4) Rinse further with
pure water at room temperature of 25 °C (or distilled water/deionised
water) for twice with each rinse lasting for at least 1 minute. C5) In the
washing stage, the water temperature should not exceed 45 °C, otherwise
the protein will solidify, and it is dicult to remove.
d) Disinfection:(d1)Use high temperature disinfection function. Set the
temperature to 93°C and disinfect it under the temperature for 5 minutes.
(d2)Start disinfection.
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).
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 (lint free white cloth) on the flat table,
point the product against the white paper (white cloth), and then dry
the product with ltered dry compressed air (maximum pressure 3 bar).
Until no liquid is sprayed onto the white paper (white cloth), the product
drying is completed.

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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.
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).

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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 introduction of
contaminants;
d) Avoid contact with parts of dierent 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 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.
5. Drying time: 30 mins.
Notes
a) Only products that have been eectively cleaned and disinfected are
allowed to be sterilized;

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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.
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:

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a) The storage environment should be clean and must be disinfected
regularly;
b) Product storage must be batched and marked and recorded.
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 Cautions
7.1 Please recharge the battery at least 4 hours before rst time usage.
7.2 During the operation, the light should be aimed straightly at the
composite resin to ensure the eect of solidication.
7.3 Avoid aiming at eyes directly.
7.4 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.

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7.5 It is forbidden to touch the charging connector with metal or other
conductor, to avoiding damage the circuit of charge or the battery.
7.6 Please recharge the battery in cool and ventilated room.
7.7 It is forbidden to self-taking-apart the battery, in order not to result in
short-circuit or leakage.
7.8 It is forbidden to extrude, shake or rock the battery. The Lithium
battery is forbidden to be in short-circuit situation and it is forbidden to
put the battery with metal or other conductors.
7.9 If you don't use this equipment for a long time, please take the
battery out and preserve separately.
【
WARNING】If the curing light works for 40s continously,the
temperature of the top of optical ber may reach 56℃.
【WARNING】Do not modify this equipment without authorization
of the manufacturer.
【WARNING】Make sure that the light hood is installed correctly
before use. Prevent light exposure to the eyes and causing damage.
According to the EU Medical Device Regulation, users / patients are obliged
to report serious events with a medical device to the manufacturer and to the
competent authority of the country in which they occurred.
8 Contraindication
The heart disease patient, pregnant woman and children should be
cautious to use this equipment.

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9 Maintenance
9.1 This equipment does not include self-maintenance parts. Please send
the unit to B.A. International or an approved dealer for repair.
9.2 Only the optical ber of this equipment can be autoclaved under high
temperature and high pressure, 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 Troubleshooting
Fault Possible cause Solutions
No indication, no
response.
1. Battery is out of
power.
2. Fault of battery.
3. The main unit battery
protection system
works.
1. Charge the equipment/
Replace the battery.
2. Replace the battery.
3. Place the main unit
into the socket on the
charger for activation.
“Er” shown on the
screen.
Fault of main unit. Send to after service for
repair.
Wink shown on the
screen.
Low battery. Reconnect the charger, if
"Er" show again after 15
minutes please change
the battery.

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Fault Possible cause Solutions
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.
The equipment
is not charging
when the adapter is
connected.
1. The adapter is not
connected well.
2. Fault of adapter or
incompatible.
3. The charging point is
impurity.
1. Reconnect.
2. Change the adapter.
3. Cleaned by the alcohol.
Eective 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 such handlings are completed, the equipment still cannot work
normally, please contact B.A. International or an approved dealer.
11 After service
The warranty of BA Optima 10 is one year from date of purchase. For
any technical issues within or outside the warranty period, please contact
B.A. International or an approved B.A. International dealer for repair.

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12 Storage and transportation
12.1 This equipment should be handled carefully, kept away from
shaking point, installed or stored at shadowy, dry, cool and ventilated
places.
12.2 Don't store it together with articles that are combustible, poisonous,
caustic and explosive.
12.3 This equipment should be stored in the environment where the
relative humidity is 10%~93%, the atmosphere pressure is 70kPa to
106kPa and the temperature is -20℃ to +55℃.
12.4 Excess impact or shake should be avoided during transportation.
12.5 Don't mix it with dangerous articles during transportation.
12.6 Keep it away from sun or snow or rain during transportation.
13 Environmental protection
Please dispose according to the local laws.
14 Representative in Europe
CB Healthcare Consulting GmbH
Am Neumarkt 34
22041 Hamburg
Germany