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USER MANUAL Rev 25/05/2023
B‐ONE
Page 1 of 16
Mechanical drive unit with coolant supply for driving instruments with compatible
connection according to ISO 3964 (DIN 13940), suitable for use in dental surgery,
implantology and stomatological surgery.
REF
Model
B‐ONE
BNE300
Refer to the "REF" on the bottom to identify the model.
ATS DENTAL srl – 51034 Serravalle Pistoiese – Italy – www.atsdental.it – info@atsdental.it
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Related Manuals for ATS Dental B-ONE
Summary of Contents for ATS Dental B-ONE
- Page 1 USER MANUAL Rev 25/05/2023 B‐ONE Page 1 of 16 Mechanical drive unit with coolant supply for driving instruments with compatible connection according to ISO 3964 (DIN 13940), suitable for use in dental surgery, implantology and stomatological surgery. REF Model B‐ONE BNE300 Refer to the “REF” on the bottom to identify the model. ATS DENTAL srl – 51034 Serravalle Pistoiese – Italy – www.atsdental.it – info@atsdental.it ...
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Page 2: Purpose - Proper Use
USER MANUAL Rev 25/05/2023 B‐ONE Page 2 of 16 1. SYMBOLS 2017/745 UE Risk of electric shock 0425 Follow Instructions for use Disposal Information V Type B appliance Supply Voltage Manufacturer REF Reference # Model Name Serial Number Web user manual ... - Page 3 USER MANUAL Rev 25/05/2023 B‐ONE Page 3 of 16 User population: This medical device can only be used by skilled and capable qualified dental health professionals, as a part of their normal activities. The user must have a perfect practical knowledge of the accepted dental rules and practices in compliance with established data of the science, and of the principles of medical hygiene such as the cleaning, disinfection, and sterilisation of medical devices, and must observe those rules, practices and principles. This medical device can be used irrespectively of specific (adult) user details, such as weight, age, height, gender, and nationality. The user must wear gloves. The user is not the patient. Users must not have any of the following ailments: Eye problems unless the latter are appropriately corrected. Disability of the upper limbs (correct holding of a rotary handpiece) or of the lower limbs (operation of a control pedal). Ear problems (use of audible signals, depending on the equipment). Memory or concentration problems (settings, sequences, or medical procedures, etc.). Specific training for users: No specific training other than the original professional training is required to use this medical equipment. Patient population: This medical device is intended for use on the following patient population: children, teenagers, adults, and elderly people. This medical device can be used irrespectively of specific patient details such as weight (except for children), age, height, gender, and nationality. The use of this medical device is prohibited on the following patient population: infants, pregnant or breastfeeding women, patients with medical complications, allergic patients, patients with a clinical zone that is not suitable for the treatment. The patient must be calm, relaxed, still, and ideally lying on a dental chair. Body areas or types of tissue treated: The medical care can only be carried out in the patient's oral environment. Principle of operation of the medical device: An electrical signal output by the medical device is supplied to the micromotor (dental or oral surgery). The micromotor is connected to medical device by a lead. The micromotor is equipped with a rotary instrument holder onto which a tool (drill, burs, etc.) is attached. The rotation of the micromotor activates the tool. ...
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Page 4: Electromagnetic Interferences
USER MANUAL Rev 25/05/2023 B‐ONE Page 4 of 16 The device is not designed to work near ionizing radiation. Do not insert metal objects into the device (risk of electric shock, short‐circuit or emission of hazardous substances). Maintenance: Before and after each use, your device must be disinfected with products recommended by the manufacturer. Before each procedure, it is essential to make sure that the accessories to be used have been cleaned, disinfected. Do not use agents containing phenol, per acetic acid, peroxide and other agents that break up the oxygen. DO NOT (for any reason), lubricate the micromotor. After lubricating the handpiece, ensure that the lubricant does not penetrate into the micromotor. Accessories: The device can only accept accessories distributed by ATS DENTAL for the particular use for which they are intended. ... -
Page 5: Package Contents
USER MANUAL Rev 25/05/2023 B‐ONE Page 5 of 16 3. PACKAGE CONTENTS REF Model “B‐ONE Autoclavable Motor + DeLuxe Pedal + L.E.D. Light” BNE300 Electronic Control Console Micromotor Assembly Autoclavable Pedal “DeLuxe” Irrigation Bag Hanger Rod Peristaltic Pump Irrigation Line (see page 15) C‐ Power Supply L.E.D. Light 1 Contrangle LED – 20:1 (see page 15) Refer to the “REF” on the bottom to identify the model. ... -
Page 6: Environmental And Transport Conditions
USER MANUAL Rev 25/05/2023 B‐ONE Page 6 of 16 4. SET UP 4.1 Environmental and transport conditions: Internal use. Altitude lower than 3000 m (10,000 ft). Temperature: 18°C / 40°C (64°F / 104°F). Relative Humidity: < 80% (non‐condensing). 4.2 Safety precautions: Do not insert anything inside the motor. The “Motor” is supplied non‐Sterile. Use only power cord as described in the section Package Contents Use for intended purposes only. Failure to observe the operating instructions may result in the patient or user suffering serious injury. Before using this product, make sure that you have studied and understood the operating instructions. Do not install where there is a risk of an explosion. The Systems are not intended for operation in the presence of flammable anesthetics or gases. ... -
Page 7: Control Panel Functions
USER MANUAL Rev 25/05/2023 B‐ONE Page 7 of 16 5. CONTROL PANEL FUNCTIONS 1. Motor Pump ON/OFF 2. Pomp ON/OFF 3. Pump flow 4. Set 5 Programs 5. Set Torque +/‐ ... - Page 8 USER MANUAL Rev 25/05/2023 B‐ONE Page 8 of 16 7. PEDAL (FOOT CONTROL OPERATION) “REF”: BNE300 The left‐hand button allows user to change the value of the coolant pump as well as the key “flow” on the keyboard. The central up button allows user to change the programs as well as the key “P ‐ programs” on the keyboard. The right‐hand button allows user to switch between forward and reverse motor rotation (when in reverse, console will emit a beeping tone), as well as the key “Fwd/Rev” on the keyboard. “DELUXE” ...
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Page 9: Programming The Unit
USER MANUAL Rev 25/05/2023 B‐ONE Page 9 of 16 9.Use After the unit has been set up and the user has become familiar with the System’s control panel functions: Attach the appropriate "E‐Type" handpiece to the motor. It can be used with most surgical contra‐angles without internal light or spray on the market. Use only handpiece that conform to ISO 3964. Change the handpiece and angle piece only when the motor not running. Insert bag hanger rod into socket on the top of the console. Attach the motor to the connector on the right side (facing the unit) on the front panel. Attach the foot control to the connector (gray color) on the front panel. Install irrigation tubing into pump on the rear panel. Use only tubing as described in “Irrigation Tube Set Up”. Switch on (on the rear panel. In every program Programs [ 1 to 5] are set the same parameters by the manufacturer. Perform torque calibration, press “Calibr” key on front panel while holding the motor. This function checks the handpiece mechanical inertia, to off‐set this value. This operation will take a few seconds, the drill will run at different speed. The drill must not be engaged in any operation when this function is performed. Calibration should be done before each surgical session or anytime the handpiece is changed or lubricated. B‐ONE will store the operative parameters for each “program” as soon as the user sets them. They will be maintained in the memory even if the central unit is switched off. For each “program” it is possible to set speed, torque, ratio, direction of rotation and flow. To reset the parameters of the manufacturer (SystemReset), press the “PUMP ON/OFF” key while the unit is switched on. Wait until the ... -
Page 10: Cleaning And Sterilization
USER MANUAL Rev 25/05/2023 B‐ONE Page 10 of 16 10. Cleaning and Sterilization Unplug the main unit from power source before cleaning or disinfecting. Do not use directly on liquids and sprays. Never immerse the unit or its parts in liquid. External surface of the console may be cleaned with a damp cloth or disinfectant wipe. The housing is not waterproof. Do not use ultrasonic or steam sterilizers. External surface of the micro motor may be cleaned with a damp cloth or disinfectant wipe. Do not place micro motor in ultrasonic sterilizers. Motor Holder and Irrigation Bag Hanger Rod may be cleaned with a damp cloth or disinfectant wipe. The exterior of the foot controls may be cleaned by wiping with a soft cloth moistened with mild detergent or disinfecting solution. WHAT CAN BE STERILIZED: ... -
Page 11: Maintenance
USER MANUAL Rev 25/05/2023 B‐ONE Page 11 of 16 11.Maintenance The micro motor cable has limited durability and is considered a consumable product. The durability of the cable is largely dependent upon use and treatment, i.e., handling, reprocessing and frequency of use. Caution must be exercised when connecting or disconnecting the micro motor and foot control cable from the device to avoid damage to the cable. Periodically inspect the micromotor cord for damage prior to use. If there is damage noted, contact the Manufacturer. LUBRICATING: ‐ Do not oil or lubricate the micromotor. RUBBER O‐RING: ‐ If necessary, substitute. Contact the Manufacturer 1.Do not attempt to disassemble the motor or motor connector. 2.Do not oil or lubricate the motor. 3. Do not attach a handpiece to the motor while the motor is running. 4.Do not bend motor cord sharply. ‐ The Micromotor is sensitive to shock. Do not drop or impact micromotor against hard surface. Failure to comply with any of the above instructions may void your warranty. 12.TECHNICAL DATA Manufacturer ATS Dental – Pistoia – Italy Nominal Power 100 VA Model B‐ONE Frequency 50/60 Hz Dimensions ... - Page 12 USER MANUAL Rev 25/05/2023 B‐ONE Page 12 of 16 14.” TROUBLESHOOTING” Problem: The central unit does not switch on. Possible cause Solution •Power cord not connected properly Make sure the power cord is properly plugged into the electrical outlet and the connector on the back of the unit. •Unit has not been switched on. Check the back of the unit to see that the on button has been pressed. •Broken connections inside. Immediately discontinue use of the device and contact your distributor, service center, • Transformer damaged. or the manufacturer directly. • PCB faulty. • Filter supply defective. • Power interrupted. Problem: The display is not working properly Possible cause Solution •Possible interference. Check to see if the central unit has been positioned too close to another electrical device which can cause interference. In this case, move the interfering electrical device further away from the central unit. •Broken connections inside. If you cannot find the cause of the malfunction, immediately discontinue use of the •Display damaged. ...
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Page 13: Accompanying Documents
USER MANUAL Rev 25/05/2023 B‐ONE Page 13 of 16 15. ACCOMPANYING DOCUMENTS Electromagnetic emissions: B‐ONE is intended for use in the electromagnetic environment specified below. The B‐ONE should only be used in such an environment. RF emissions Group 1 B‐ONE uses RF energy only for its internal function. Therefore, its RF emissions are CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 Harmonic emissions Class A B‐ONE is suitable for use in all establishment including domestic establishments and IEC 61000‐3‐2 Conforms those directly connected to the public low‐voltage power supply. Voltage fluctuation/ flicker Conforms emissions IEC 61000‐3‐3 Electromagnetic Immunity: B‐ONE is intended for use in the electromagnetic environment specified below. The B‐ONE should only be used in such an environment. Immunity test Test level Compliance level Electromagnetic environment ‐ guidance EN 60601‐1‐2 6kV contact ... - Page 14 USER MANUAL Rev 25/05/2023 B‐ONE Page 14 of 16 Immunity Test Test level Compliance level Electromagnetic Environment ‐ Guidance IEC 60601‐1‐2 Conducted RF 3 Veff from 150KHz to 3 Veff from 150KHz Portable and mobile RF communication equipment EN 61000‐4‐6 80MHz to 80MHz should be used no closer to any part of the B‐ONE, including cables, than the recommended separation distance calculated from the equation applicable to the Radiated RF 3 Veff from 80MHz to 3 Veff from 80MHz frequency of the transmitter. IEC 61000‐4‐3 2.5GHz to 2.5GHz Recommended separation distance ...
- Page 15 USER MANUAL Rev 25/05/2023 B‐ONE Page 15 of 16 Included in Ref: BNE300 – Model: B‐ONE 1 X Contra‐Angle Handpiece ‐ Ref: “201‐ATSL” Contra-angle handpiece «201-ATSL» Implantology 0425 TECHNICAL DATA Gear Ratio 20:1 40000 RPM Max motor speed Max operating speed 2000 RPM >55 Ncm Torque Clamping system Shank diameter of the burs 2.334-2.350 mm Symbols Thermo washer...
- Page 16 USER MANUAL Rev 25/05/2023 B‐ONE Page 16 of 16 Manufacturer For more information, contact: ATS DENTAL srl Via Vecchia Prov.le Lucchese, 49 51034 Serravalle Pistoiese Italy +39 0573 518137 www.atsdental.it ‐ info@atsdental.it Note: the instructions above have been validated by the manufacturer of the device as suitable for preparing the device for reuse. The proper implementation of the preparation process, as well as achieving the desired result, are full responsibility of the person performing the operation. ATS DENTAL SRL reserves the right to modify the present DFU without prior notice. Via Vecchia Provinciale Lucchese, 49/F ‐ Loc. Masotti 51034 SERRAVALLE PISTOIESE (PT) ‐ Italy Tel.: +39 0573 518137 – Fax: +39 0573 1711140 info@atsdental.it internet: www.atsdental.it ...
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