B.A. International Optima OS600L User manual

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
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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

5.3 Memory function
5.3.1 Memory button
Press the memory button to access memory address where detailed figures (Gear ratio, Torque, Speed, For/Rev, Coolant) of each function in program are saved.
Memory address cycles through numbers 1 to 9 upon pressing Memory button each time.
※Initial setting (Factory settings) : Memory
The memory
number(1-9) currently
selected is being
displayed.
Memory
Button
Program
Drilling
Tapping
Remove tap
Implant
Remove
Rock screw
Gear ratio
20:1
20:1
20:1
20:1
20:1
20:1
Torque [Ncm]
55
40
40
40
55
10
Speed [rpm]
1,500
50
50
50
50
50
Motor direction
Forward
Forward
Reverse
Forward
Reverse
Forward
Coolant level
4
3
3
3
0
0
5.3.2 Saving data
Memory
Button
Memory 1
①Drilling set value
②Tapping set value
③Remove tap set value
④Implant set value
⑤Remove set value
⑥Rock screw set value
Memory 9
①Drilling set value
②Tapping set value
③Remove tap set value
④Implant set value
⑤Remove set value
⑥Rock screw set value
...
...
...
...
...
...
...
Save detailed figures in memory which are currently set (Gear ratio, Torque, Speed, For/Rev, Coolant) for each function in program.
press and hold the memory button for 2sec to start saving data. A beep will sound and ‘No.’ will continuously flash.
Press the Memory button again to select the memory address where data is to be saved.
Press the memory button for 2sec once more to save the data. ‘No.’ will stop flashing and 2 beeps will sound again when saving is completed
The memory number (1~9) currently selected is being displayed.
‘No.’ flashes continuously until data is saved.
10

5.4 Setting direction of motor rotation
Rotation
Button
The initial setting is Forward direction and Reverse is selected upon pressing the button
The letters "REV" and arrow are turned on upon selecting Reverse, and a beep will sound.
①The letters "FOR" and arrow are turned on upon selecting Forward.
②The letters and arrow falsh during the motor operation.
③The same goes for selecting Reverse. A beep sound occurs when switching between Forward and Reverse.
FOR.
REV.
5.5 Gear ratio change
5.6 Optic LED On/Off
Gear ratio
Button
Optic LED
Button
Press Optic/Non optic button to operate LED within the motor BA160530 which is designed for Optic.
It selects gear ratio in accordance with that on a handpiece.
Gear ratio alters upon pressing Gear ratio button each time.
①When the LED is on, the LED symbol is displayed.
②During the motor operation, LED is on.
③When motor stops, the LED turns off after 3 seconds
④When the LED is off, the symbol not displayed.
Gear Ratio : ①1:1 ②1:2 ③16:1 ④20:1 ⑤27:1 ⑥32:1
It alters in turn from number ①to ⑥upon pressing the button each time.
5.7 Controlling Irrigation flow rate
Coolant
Button
Water injection rate alters in turn by five levels upon pressing Coolant button.
30 ml/min
60 ml/min
90 ml/min
110 ml/min
130 ml/min
11

5.8 Change in torque value
5.9 Change in speed
Torque Up/Down
Button
SPEED Up/Down
Button
Torque section on the display flashes upon pressing torque button.
Torque is controlled using the button for adjusting set value.
Torque setting mode is exited by pressing Torque button again or another button for another function or when the motor is operated.
Speed section on the display flashes upon pressing Speed button.
Speed is controlled using the button for adjusting set value.
Speed setting mode is exited by pressing Speed button again or another button for another function or when the motor is operated.
Change the torque value of motor, 5 N.cm increase. Gear ratio Torque(Ncm) Gear ratio Torque(Ncm)
1:1 - 1:2 -
16:1 5~60 20:1 5~70
27:1 5~80 32:1 5~80
Gear ratio Speed(rpm) Gear ratio Speed(rpm)
1:1 200~40,000 1:2 400~80,000
16:1 12~2,500 20:1 10~2,000
27:1 7~1481 32:1 6~1250
5.10 Operation of implant engine
5.11 Auto Calibration
SPEED Up/Down
Button
Implant engine operates upon completion of all settings.
When motor operates by pressing foot switch, the letter 'R' on display and the surrounding border flickers in turn.
The torque and speed indicate the current figures and a beep sounds when altered torque value reach 90% of set value.
Motor stops when it reach 100% of set value.
Auto Calibration is performed upon simultaneously pressing both buttons longer than 2 seconds.
When users press the speed up and down button simultaneously for 2 seconds, auto calibration is executed.
When auto calibration is executed, the motor starts with a beep sound.
Auto calibration is completed when speed increases from 0 to 40,000 RPM on the display and the motor will stop when it's done.
Auto calibration is recommended when actual speed of the motor is different from speed on the display.
Auto calibration is recommended after sterilization.
12

Chapter 6. Maintenance
6.1 Manual cleaning
1) Separate the motor and Foot Switch connected in the Control Unit.
2) Prepare a cloth (preferably cotton) or soft brush moistened with isopropyl alcohol.
3) Clean foreign substance on the entire surface and in the gaps with cloth or brush soaked in isopropyl alcohol for at least 3 minutes.
4) Repeat the cleaning process if foreign substance is found.
6.2 Inspection
1) Inspect whether there is any foreign substance visible to the naked eye.
2) Check the operating condition.
3) Repeat the cleaning process if foreign substance is found.
4) Repeat the above procedure for every single use.
6.3 Sterilization
Sterilization Applicable Products : Motor, Motor connection cable
1) Disconnect the motor cable from controller.
2) Attach the motor cap to the handpiece connection of the motor.
3) Sterilize the motor equipped with the cap and motor cable either before or after use under the following conditions.
※Sterilization by moist heat(134~135℃) for 3 minutes in a steam sterilizer (Autoclave)
Clean the product before and after use.
• Please sterilize after using the product.
• We do not recommend you to sterilize on plasma sterilization or
EOG sterilization.
• Do not disconnect the motor from the motor cable when sterilizing.
6.4 Change fuse
①Switch off and unplug the unit as per 5.1 ②Carefully remove the fuse box ③Replace the fuses with new ones
of the same fuse type.
④Re-insert the fuse box
Extra fuse
Needed
to change
Type
Gravity displacement type sterilizer
Air-removal steam sterilization(pre-vacuum)
Sterilization conditions
At least 30 minutes at 121℃
At least 4 minutes at 132℃
Drying time
30 minutes.
30 minutes.
13

Chapter 7. Troubleshooting
7.1 Description of Error Message
7.1.1 Error display screen
Upon occurrence of error, a warning sound is made and then the number subject to the error flickers on error display part of the screen.
Error code Status Cause of error Remedy
E1 Error on motor sensor Defective motor hall sensor,
poor connection Contact your BA repair centre
E2 Motor error Defective motor and
poor connection Reconnecting and checking the motor
E3 Overload error Overload on motor Restart after turning off the power
then leave unit on standby
E4 Error on cooler temperature
(Heat sink temperature error)
Cooler being overheated,
breakdown of temperature sensor
Restart after turning off the power
then leave unit on standby
E5 Transformer error Defective transformer, overheating Contact your BA repair centre
E6 Error on circuit and voltage Defective circuit Contact your BA repair centre
E7 Error on pedal connection Poor pedal connection Reconnecting and checking the pedal
Error number(E1~E8) will pop up and keep
flashing depending on each cause.
7.2 Breakdown Description
Error Cause of error Remedy
Display screen does not appear upon turning on the power on.
Motor does not operate upon stepping on the foot switch.
Inaccurate connection of power cord Checking plug connection
Inaccurate connection of power cord Checking plug connection
Breakdown of foot switch Contact your BA repair centre
Breakdown of power cord Contact your BA repair centre
Breakdown of fuse Replacing fuse
14

Chapter 8. Accessories
8.1 Accessories
8.2 Information on After-Sale Service
▶Distributor: B.A. International Ltd.
▶Address: Unit 9, Kingsthorpe Business Centre, Studland Road, Northampton, NN2 6NE, UK. ▶Contact: [phone] [email protected] www.bainternational.com
▶Made in : Republic of Korea
8.3 Warranty
▶Implant engine controller, motor : 1 year
▶Damage due to customer's mistake, misuse of the product and normal abrasion of motor bearing are not included.
Motor
(BA160530)
Foot switch
(BA160535)
Motor connection cable
(BA160540)
Foot switch cable
(BA160541)
Power cable
(BA160542)
Irrigation hanger
(BA160543)
Foot switch hanger
(BA160544)
Irrigation tube
(BA690110)
Hanger bolt
(BA160546)
Tube holder
(BA160545)
Stand
(BA160548)
Instruction for use
Motor cap for autoclave
(BA160547)
15
Chapter 9. Disposal
10.1 Disposal guideline
10.1.1 Disposal of Main controller and foot switch and motor
▶Follow your country specific laws, directives, standards and guidelines for the disposal of used electrical devices.
▶Ensure that the parts are not contaminated on disposal.
10.1.2 Disposal of the packaging material
▶All packaging materials have been selected according to environmentally compatible and disposal aspects and can be recycled.
Please send old packaging materials to the relevant collection and reprocessing system.
This way, you will contribute to the recycling of raw materials and the avoidance of waste.

Annex A
The product is suitable for use in an specific electromagnetic environment.
The customer and/or the user of the product should assure that it is used in an electromagnetic environment as described below.
Emission Test
RF-emission CISPR 11
RF-emission CISPR 11
Compliance
Group 1
Class A
Harmonic emissions IEC 6100-3-2 Class A
Voltage fluctuations/
flicker emissions IEC 61000-3-3 Complies
Electromagnetic Environment Guidance
The product use RF energy only for its internal function.
Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment.
The product is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purpose.
10.2 Electromagnetic Immunity
10.1 Electromagnetic Compatibility
The product is suitable for use in a specific electromagnetic environment.
The customer and/or the user of the product should assure that it is used in an electromagnetic environment as described below.
Emission Test
Electrical fast transient/bursts
IEC61000-4-4
Electrostatic discharge(ESD)
IEC61000-4-2
IEC 60601- Level Compliance Level
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
Surge
IEC61000-4-5
Electromagnetic Environment Guidance
Floor should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the relative humidity should be at least 30 %
Mains power quality should be that of a typical commercial and/or hospital environment
Mains power quality should be that of a typical commercial and/or hospital environment
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC61000-4-11
<5% UT (>95% dip in UT)
for 0.5 cycle 40% UT
(60% dip in UT)
for 5 cycles 70% UT
(30% DIP IN UT)
for 25 cycles <5% UT
(>95% dip in UT) for 5 sec
<5% UT (>95% dip in UT)
for 0.5 cycle 40% UT
(60% dip in UT)
for 5 cycles 70% UT
(30% DIP IN UT)
for 25 cycles <5% UT
(>95% dip in UT) for 5 sec
3A/m 3A/m
Mains power quality should be that of a typical commercial and/or hospital environment.
If the user of the product requires continued operation during power mains interruptions,
it is recommended that the product be powered from an uninterruptible power supply or
a batter
Power frequency magnetic fields should be at levels characteristic of a typical location in
a typical commercial or hospital environment.
91

Emission Test IEC 60601- Level Compliance Level Electromagnetic Environment Guidance
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, people and animals.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered, if the measured field strength in the location in which the product is used exceeds the applicable RF compliance
level above, the product should be observed, additional measures may be necessary, such as reorienting or relocating the product.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency
of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, people and animals.
Rated maximum output power of
transmitter in watts (W)
Separation distance according to the frequency of transmitter in meter (m)
150 kHz to 80 MHz d = 1.2√P 80 MHz to 800 MHz d = 1.2√P 800 MHz to 2.5 GHz d = 2.3√P
3 Vrms
150 kHz
to 80 MHz
3 Vrms
Conducted RF
IEC 61000-4-6
3V/m
80 MHz
to 2.5 GHz
3 Vrms
Radiated RF
IEC 61000-4-3
for 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in Watt (W) according to
the transmitter manufacturer and d is the re-commended separation distance in meters
(m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey(a), should be less than the compliance level(b) in each frequency
range Interference may occur in the vicinity of equipment marked with the
symbol described lateral.
Portable and mobile RF communications equipment should be used no closer to any part
of the product, including cables, than the recommended separation distance calculated
from the equiation applicable to the frequency of the transmitter.
Recommended separation distance :
d = 1.2√P d = 1.2√P for 80MHz to 800MHZ d = 2.3√P
10.3 Recommended Separation Distances between portable and mobile HFcommunications equipment and the product
The product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the product – according on output power and frequency of the communications equipment – as recommended in the following table.
0.01
0.01
0.1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
92

Distributor: B.A. International Ltd.
Address: Unit 9, Kingsthorpe Business Centre, Studland Road, Northampton, NN2 6NE, UK.
Contact: [phone] [email protected] www.bainternational.com
Address: Karl-Marx-Str. 6 16540 Hohen Neuendorf Germany
Contact: [phone] Fax: [phone]
Manufacturer: MicroNX co., Ltd.
MicroNX co., branch office
Address: 22, Maeyeo-ro 1-gil, Dong-gu, Daegu, 41059 Republic of Korea
Contact: [phone] micr[email protected] www.micronx.co.kr Made in : Republic of Korea
The EU directive 93/42/EEC was applied in the design and production of this medical device
04. 2019