4
Regarding to WARNINGS
Warning
Notice
5
Warning
Caution
Notice
Warning
Classification Degree of Injury and Damages
The Warning is to protect the loss of life
and property
The Caution is to protect the serious and
slight injuries and possible loss of property
The Notice is to notify mandatory for safety.
◆Please use the product properly after read the
warning before operation.
◆Indication of the Warnings are to protect injury
and damages to users and others. Those are
all for safety so, please follows the instructions.
◆Class II equipment
To identify equipment meeting the safety requirements
specified for Class II equipment according to IEC 60536.
Note - The position of the double-square symbol shall be
such that it is obvious that the symbol is part of the
technical information and can in no way be confused with
the manufacturer’s name or other identifications.
◆Only Rechargeable battery is allowed to be used. Do not use
manganese and alkaline battery. If mishandled, that causes
leakage or ruptures.
◆Do not touch the AC power plug with wet hands. There are
shock hazard.
◆Do not drop any kind of liquid and water on the motor handpiece
and adapter. The short circuit may cause fire, electric shock or
corrosion of the product.
◆Unauthorized modification and dismantling is prohibited.
◆Do not drop the motor handpiece or adapter. Install the
adapter on flat ground and safe place.
◆If quick silver flows into eyes that can lead to blindness.
Wash off the eyes with clean water promptly and consult
with doctor.
◆If quick silver flows on cloths and skin, it may cause skin
problem. Wash off with clean water promptly.
◆If the quick silver flow out from the motor handpiece or there
are change of the exterior or part discolor of the motor
handpiece, please stop to use and contact to seller.
◆If the product is not in use for long period, please put out
the battery. There is possible leakage.
◆Please change the same battery kinds together to use.
Otherwise, it may cause leakage and battery rupture.
◆Please use the designated battery and charger for the product.
◆Do not disassemble or change the motor.
◆The system damages occurred if the product is used near of
electromagnetic interference.
◆The motor handpiece designed as Nickel mercury battery
(rechargeable). The Ni-Cd battery is possible to use but
the charging time and usage period can be shorten because
the charging current is different.
◆The motor handpiece spend even small electric power during
power off. And genially, rechargeable battery is discharging
little by little when the product is not in use after charged fully.
The product is recommended to be charged before use.
◆Machine is equipped with Sensor against low voltage, however,
sometimes machine fails to perceive low voltage especially
after re-powered for a few minutes, which is usual in normal battery.
◆Please charge the battery which is rechargeable after use it
as much as possible. Repeat charge and discharge after short
time use, usage period of battery can be shorten (by memory effect)
In this case, repeatation of charge and discharge of fully used
battery can make it better condition.
◆If the product is not in use for long period, please put out
the battery.
◆Do not use the product near of the flammable product or
nitrous oxide.
◆The product has circuit which can protect of file damage,
but the file can be damaged by strong torque or resistance.
◆Please do not leave the child alone with the product and
keep attention to child, elderly and disabled person to be
close to the product or not.
◆Do not touch signal input, signal output, or other connectors,
and the patient simultaneously.
◆External equipment intended for connection to signal input,
signal output or other connectors, shall comply with relevant
IEC Standard (e.g., IEC60950 for IT equipment and
IEC60601-1 or IEC60601-1-1 series for medical electrical
equipment) If in doubt, contact qualified technician or local
representative.
MACHINE CLASSIFICATION
Caution
◆Please consider the safety of patient first and take care during
the product operating.
◆Only qualified person in dental surgery can be allowed to
use the product
◆Please purchase the battery recommended by manufacturer
and take care of the usage manual of battery manufacturer
before use it for the product.
◆Do not use the machine with the file which is bended, damaged,
deformed and/or not in ISO standard, otherwise, it might cause
injury by some possible fragments.
◆Do not place or maintain the battery in the place in high
temperature such
as the place exposed to direct sunlight, inside of a car in high temperature
or beside of stove and fire and so on.
◆Please take care of shaving, vibration, noise and heat of the product before
use and test by rotating naturally. Stop to use the product if feel abnormal
condition of the product and contact to representative.
◆Keep bur or file clean, otherwise dust might cause poor chucking power
and it may cause vibrations during operation.
◆ELECTRIC SAFETY
In case of some faults in Electric Cord, Plug, and Connector,
do not use machine, otherwise it might cause Fire and
Electric Shock. Do not pull out the Plug with wet hand.
Whenever the Plug to be pulled out, to be sure to grasp
the Plug body. Do not bend Electric Cord excessively.
Do not put heavy material onto Electric Cord.
-Never fail to use Outlet which is equipped with earth
connection and please be instructed the way how to install
the earth connection from manufacturer or technicians.
-Do not put several Plugs into one Outlet though multi-plug,
which might cause Fire and Electric Shock.
-Before use, please check if the control unit has set the gear
ratio to match with the gear ratio in the contra angle.
-If motor operating speed is too fast or stop during operation,
contact dealer.
-Take care not to drop or damage the motor and contra angle
handpiece. Do not operate the product if product is not
operated properly after drop on the floor or water, contact
the Head office or Dealer. That case may cause bur vibration,
excessive heat and damage to the ball bearings.
◆DISPOSAL
-When disposal of Control units, be sure to keep
regulations which stipulate disposal of industrial waste.
-When disposal of Motor and Handpiece, be sure to keep
regulations which stipulate disposal of medical waste.
-Used and finished battery is recommended to be back to
supplier. The product use battery which is composed of
Nickel Metal Hydride, rechargeable, however, some
countries stipulate it to be disposed as special waste.
◆INTEND USE
ACL(B)-41EP, ACL(B)-42EP and ACL(B)-45EP are for indicated for use
by dentists in standard endodontic procedures using rotary files and
rotary endodontic drills(Gates-Glidden)
Type and Degree of protection against electric shock:
Class II/Type BF
Degree of protection against water (vertically falling drops)
stipulated in IES529 : IPX 0.
Machine should not be used at the place close to flammable
Anesthetics and Oxygen.
Operation Mode: intermittent load in consecutive operation
Operation Time: Loading max. 3 minutes
Pause Time: min. 10 minutes.
Machine has been confirmed that it complies with the rules of medical machinery
IEC 60601-1-2007 which provides reasonable protections against harmful
interference in typical medical installations.
Machine can radiate radio frequency energy. If not installed or used in accordance
with the instructions, it might cause harmful interference possibly to other devices
in nearby, however, it is not assured that it will occur to a particulate installations.
If machine cause harmful interference to other devices and that interference is
determined by their ON/OFF, users are encouraged to try to correct the
interference by one or more of the following measures:
-Machine needs to be used by a medical specialist or qualified person.
-Do not use machine at the place too close to other devices.
-Consult with manufacturer or qualified service technicians for the electronic
safety information of the machine
◆Users are responsible for operation, maintenance and inspection.
◆Applications of machine is restricted by this manual and not-
recommended applications by a manufacturer should be avoided.
◆An arbitrary use might cause users’ injury and loss of property
and a manufacturer shall not be responsible for the results which
are made by the operation which is not mentioned in this manual.
◆Keep the speed of the usage tool as recommend by tool manufacturer.
The excess speed limitation might cause the accident.
◆Contact dealer when display shows wrong message,
it might cause an accident.
◆Only recommended product and consumable parts by manufacturer
have to be used with the product, otherwise, it may cause the accident.
◆Operating Condition 1) Temperature: 10°C ~ 40°C
2) Humidity: 30% ~ 75%
3) Atmospheric Pressure: 700 ~1,060hpa
◆The temperature of the handpiece goes up to max. 43°C when
atmosphere temperature is 40°C.
◆Before changing the head or file, turn off the power of the motor handpiece.
Changing it during power on may cause unintended rotation by accidental
activation of the ON/OFF button.
◆When inserting the motor handpiece into the battery charger, position the
handpiece correctly. Pushing it into the charger forcibly in the incorrect
direction may cause damage.
◆Take care not to put needle, pin into the charging terminal of the
battery charger.
◆Place the motor handpiece into the charger after clean the liquid or
dust off. If the charging terminal is in dirty, it can be rusted and cannot
be charged properly.
◆Do not lubricate the motor handpiece.
◆Do not heat sterilize the motor handpiece. Do not autoclave the
motor handpeice.
WARNING