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B.A. International Optima OS600L User manual

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Optima OS600L
Instructions for Use
Implant and Surgical Unit BA160510 / 9795068 / ISE-270M
EN 2-15p / ES 16~30p / FR 31~45p / IT 46~60p / NL 61~75p / DE 76~90p
language
ContentsSymbols
2
2
3
6
8
13
14
15
15
91
Instructions for use
EN
Chapter 1. Introduction
Chapter 2. Safety Information (Precautions and Warning)
Chapter 3. Description
Chapter 4. Installation
Chapter 5. Operation
Chapter 6. Maintenance
Chapter 7. Troubleshooting
Chapter 8. Accessories and Service
Chapter 9. Product Disposal Guideline
Annex A
1
Catalog number
Serial number
Manufacturer
Authorized representative in the European Community
Manufacturing Date
BF type applied part
Alternating current
Keep dry
Caution
Consult operating instructions
Do not dispose with domestic waste
Water proof grade
Distributor
IPX1
Implant and Surgical Unit BA160510 / 9795068
Chapter 1. Overview
1.1 Operating Principle
This device is an unit that consists of a main body, BLDC (brushless DC) motor, and foot pedal switch for driving and operating a handpiece for dental implant procedures,
to be used in dentistry in the field of implant surgery.
The main body of this device is powered by an external power supply that converts alternating current to direct current, which turns the BLDC motor; the rotation power of
which combines with the handpiece to perform the dental implant procedure.
The main body of the implant unit can be adjusted in terms of its torque, rotation speed, water injection volume, and rotational direction.
The BLDC motor can be operated using the foot pedal switch.
1.2 Purpose of Use
This is an engine used to power handpieces used for implants when performing dental implant procedures.
1.3 Users
Only qualified dentists may use this device in a professional environment..
1.4 Indications of Use
1) Where there is an absence of gum or teeth caused by cavities, gum disease, accidents or tumors.
2) Where enamel ablation is not recommended so as to protect the adjacent natural teeth.
3) Where the patient does not want denture treatment.
4) Where the patient wants to replace partial or full dentures that were previously used with a fixed-type dental prosthesis.
5) Where the patient wants full dentures to be replaced with some partial dentures and some fixed-type.
6) Where the patient requires implant support in relation to the lower dentures to maintain the full denture and also improve its function.
1.5 Checklist Prior to Use
1) Be sure to read the user manual prior to use.
2) Only to be used by a professional in a professional environment..
3) Not to be used for anything other than its intended use.
Chapter 2. Safety (Warnings and Cautions)
2.1 Risks
1) If the cause of malfunction is unknown or if it cannot easily be resolved, please contact your dealer or your nearest BA repair centre.
2) If the display shows incorrect information, please contact your dealer or your nearest BA repair centre immediately.
3) Do not let the patients come into contact with the signal input piece, the signal output piece or other connecting pieces.
2.2 Notice
1) This product was designed to be used in implant procedures. The device should only be used in accordance with its intended usage and method.
2) The safety of the patient comes first and foremost. Be sure to pay sufficientattention when using the device.
3) Carefully study the user manual prior to use. Please familiarise yourself with the function of each part before using.
4) The main body and foot pedal switch of the implant unit cannot be cleaned in an autoclave. If the main body becomes contaminated, disconnect the power and clean with a clean,
damp cloth, then wipe away the moisture with a dry cloth.
5) Prior to plugging in the device, check to confirm that the input voltage matches that of the device.
6) Any used water injection tube should be disposed of as medical waste.
2
2.3 Caution
1) Never attempt to disassemble or modify the device. Once the device is disassembled,you will no longer be entitled to after sales service from the manufacturer.
2) Never add oil to the inside of the BLDC motor. This can cause the bearings to malfunction and get hot.
3) Do not use thinner, benzene or any other solvents to clean.
4) Use only products and supplies that are prescribed by the specifications of the manufacturer.
5) If the power cord or plug socket is broken or damaged, do not use the deviceand inquire with the manufacturer. This could pose a risk of electric shock or fire.
6) When removing the power cord from the socket, be sure to pull the plug head, and do not do this with wet hands. Do not use the device with the power plug loosely connected.
This could pose a risk of electric shock or fire.
7) Do not install near a heat source, and do not place near lit candles or cigarettes. This could pose a risk of fire.
8) Determine if there are any elderly, sick, injured, disabled persons, pregnant women or children near where the device is installed, and keep a close eye on such persons.
Do not leave children alone with the device.
9) Ensure that the main body of the implant engine and the foot pedal do not come in contact with water, saline solution or other contaminants. If the device is not operating properly,
or contaminants have entered the product, do not operate the device under any circumstances and inquire with the manufacturer instead.
10) Please use the device in accordance with the use stated in this user manual and refrain from using the device for any other purpose than that recommended by the manufacturer.
The manufacturer will not be held liable for any accidents caused by a disregard for the instructions in the manual.
11) The external equipment for connecting the signal input piece, signal output piece or other connecting pieces must meet the IEC publication standards.
2.4 Warning
1) Prior to or during use, if you notice any abnormal symptoms including vibration, heat or abnormal noise, discontinue any use immediately and inspect the device.
2) Always use earthed socket for power supply.
3) With regard to tools used for implant procedure, please maintain the speed recommended by the manufacturer. Exceeding the recommended speed carried the risk of an accident.
Chapter 3. Product Description
3.1 Description of System, Components and Functions
※Handpiece – sold separately
Motor (BA160530) Main controller (BA160510) Foot switch (BA160535)
3
3.1.1 Main Controller (BA160510)
1) Front 2) Rear
Display Power cable terminal
Fuse box Power switch Foot switch terminal
Groove on
irrigation hanger
Connection for irrgation hanger
Rotation button Program button Memory button
Gear ratio button
Coolant button
Optic LED buttonSpeed Up/Down button Torque Up/Down button
Water injection
pipe fixture
Motor connection
3.1.2 Foot switch (BA160535)
Foot switch connector
Foot switch coable
Rotation button
Program button
Coolant button
Hanger hole
Operation button
3.1.3 Motor (BA160530)
Optic LED
Motor connectionHandpiece connection
4
3.2 Product Performance
1) Main controller (BA160510)
2) Motor (BA160530)
Max. Speed
Max. Torque
Max. Current
Dimension
Optic
Weight
Coupling
40,000 rpm
7 Ncm
6 A
Ø24 × L100 ㎜
White LED
165g
ISO 3964
Power Supply voltage
Frequency
Power Consumption
Max. Coolant flow rate
Fuse
Dimension
220V
60HZ
150VA
130 ml/min
2 × 250 × T2.0AH
300×230×135 ㎜[Width×Length×Height]
3) Foot Switch (BA160535)
Speed control
Control Functions
Control Functions
Variable
Program control / Coolant control / Forward / Reverse
IPX1
3.4 Environmental Conditions (Storage, Relocation, Operation)
1) Storage conditions
Temperature : -10°C ~ +50°C
Humidity : 10 ~ 85%
Air pressure : 500hPa ~ 1060hPa
2) Relocation conditions
Temperature : -10°C ~ +50°C
Humidity : 10 ~ 85%
Air pressure : 500hPa ~ 1060hPa
3) Operation conditions
Temperature : +10°C ~ +35°C
Humidity : 30 ~ 85%
Air pressure : 700~1060 hPa
5
Chapter 4. Installation
4.1 Installation of hanger and Foot switch hanger
4.1.1 Installation of hanger
①Insert irrigation hanger into hanger hole.
②Fix by connecting hanger bolt.
4.1.2 Installation of Foot switch hanger
①Insert foot switch hanger into hanger hole.
②Fix by connecting hanger bolt.
4.2 Connection of Motor
①Plug the motor connector flush into the groove.
②Connect the motor connector CAP.
Be careful when plugging in the connector
4.3 Connection of power cord and foot switch
① ②
①Connect power cable to power cable terminal.
②Connect Foot switch connector to Foot switch terminal.
Be careful to fit into the groove upon connection.
6
4.4 Installation of irrigation tube
②Attach the motor cable and irrigation tube
in regular intervals using the coolant clip.
External spray nozzle
20:1
Irrigation tube
Irrigation tube Tube clip
Internal spray nozzle
External spray nozzle
‘Y’tube
Irrigation tube
Tube clip
Motor cable
Irrigation tube
Coolant clip
‘Y’tube
①Attach the irrigation tube to the straight
or contra-angle handpiece.
Irrigation tube
Push button
Connect irrigation cover
and Irrigation tube
Tube clamp
Coolant container
Insert needle
③Open Irrigation cover by pressing Push button.
④Put Irrigation tube in the groove.
⑤Close Irrigation cover.
⑥Close the tube clamp.
⑦Open the tube clamp before start-up.
⑧Stick the insert needle into the coolant container.
⑨Hook-in the coolant container on the bottle holder.
7
Chapter 5. Operation
5.1 General use
1) Turn on the Power switch of implant engine controller
2) Programs are selected in turn by pressing Foot switch or P button of implant engine controller.
3) Check the displayed torque, rotation speed, irrigation flow rate, gear ratio and direction of rotation.
4) It starts rotating upon pressing Foot switch. It rotates at low speed with light press on Foot switch and rotates at full speed with hard press.
When the irrigation flow rate is preset, the pump starts rotating as well.
5) When load reaches the maximum value of preset torque, motor stops rotating.
6) It stops rotating upon releasing Foot switch.
7) Turn off the implant engine controller
①Connect the engine to the power cable.
②Turn the engine on at the power switch.
①When not in use, turn off the engine at the power switch
②Disconnect the engine from the power cable
8
5.2 Program Mode
5.2.1 Selecting a program
A user selects a program necessary for surgery with this button.
Program cycles through numbers 1 to 6 when pressing the program button each time.
It changes in order of Drilling→Tapping→Remove Tap→Implant→Remove→Rock screw.
A white border highlights the selected program.
Activating the thread cutting
function is only possible with
the tapping program.
Program
Button
5.2.2 Thread cutting function
Program
Button
①Foward rotation ②③④Foward rotation
when foot
sweetch is on
Rotation stop
when foot
sweetch is
released
Reverse rotation
when loading
beyond the preset
torque limit value
5.2.3 Deleting a program
This function deletes unnecessary and unused programs.
Select an unused program and delete it by pressing this
button for more than 2 seconds.
This function restores the deleted programs.
Restores all deleted programs pressing this button more than 2 seconds.
Program
Button
5.2.4 Restoring programs
Rotation
Button
9