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ART-M1 Magnetostrictive Ultrasonic Scaler
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1. Do not immerse the ART M1 in water or liquid If the ART MI has water damage return the machine to Bonart for servicing Do not modify the ART M1 Modifications will invalidate the warranty on the machine as well as invalidate safety codes and endanger the patient and operator Section III Precautions 3 A Precautions for all Ultrasonic Scaler Units and Systems Ensure sufficient water flow to the scaler tip during use to cool the hand piece and insert Take precaution as all ultrasonic scalers produce aerosols that may transmit contagious diseases Use inserts manufactured by Bonart for optimal performance and results Keep the unit away from intense heat Excessive heat may damage the electronic components Switch the water valve off when the ART M1 is not in use Avoid treating patients with pacemakers due to the magnetic field produced by the ART M1 The magnetic field may cause monitoring devices to malfunction and provide inaccurate readings 3 B Precautions for Ultrasonic Prophylaxis Procedures Scaling tips inserts will wear with use Inserts with 2mm of wear will lose approximately 50 of their scaling efficiency In general it is recommended that inserts be discarded and replaced after 2mm of wear to maintain optimal efficiency and avoid breakage Avoid direct contact of inserts with the patient s lips cheeks and tongue Do not reuse scaling tips inserts that are damaged bent or reshaped Discard immedi
2. Push the insert firmly into the hand piece If installed properly the insert band should be flush against the top of the hand piece To remove the insert pull the insert at the grip Be careful not to cut your hand while removing the insert 4 Check the water tube connection to the water supply source and main unit Section VI General Description and Information of Parts Figure 2 ART MI Outlook diagram 1 Main Unit The main unit generates power and produces a signal that is passed to the hand piece The hand piece is then powered up and vibrates the installed insert 14 2 Hand piece The hand piece is a housing for scaling inserts Inserts are interchangeable and can be installed with a firm push To remove the insert pull from the grip but be careful not to puncture or cut yourself Aside from Bonart inserts Dentsply Cavitron and Hu Friedy inserts are also compatible with the ART M1 When the hand piece is powered the hand piece will begin to heat due to the power generated by the main unit To cool the temperature of the hand piece a stream of water is released into the hand piece and through the tip This stream of water is also used to wash away tooth calculus and tartar CAUTION Make sure that new insert is firmly seated The insert band should be flush against the top of the hand piece 3 4 CAUTION Do not depress the footswitch when there is no insert installed Doing so will cause th
3. indicators or chemical indicators for ensuring the efficiency of the sterilization cycle are recommended NOTE Routine spore testing will determine the sterile conditions of your office NOTE The Sterilization Assurance Level SAL of steam autoclave should be 10 According to ISO 13683 Sterilization of health Care products 10 WARNING High room temperature conditions improper dilutions or extended immersion time in chemical sterilizers can result in damage to the plastic and other materials of the insert Tips CAUTION The use of a dry heat oven incompatible chemical vapor type sterilizers or quaternary ammonium compounds must be avoided as damage can result to the plastic and elastomeric materials Main Unit Carefully wipe the Main Unit with absolute alcohol or an Acrylonitrile Butadiene Styrene ABS plastic compatible disinfectant to prevent damage to the plastic components of the casing Section V Installation 5 A General Information If the installation of your ART M1 system is performed by an unauthorized distributor of Bonart products check to see that the requirements below are followed 5 B Water Line Requirements e Incoming water supply line pressure to the Scaler must be 25 psi 172 kPa minimum to 60 psi 414Kpa maximum If your dental water supply line pressure is above 60 psi install a water regulator on the water supply line to your ART M1 unit e After the above installation requirement
4. is fulfilled thoroughly flush the water prior to connecting to the scaler e Please use the manual shut off valve on the dental water system supply line to shut off water when the office is unoccupied 5 C Electrical Requirements Refer to Section X Specifications zd 5 D Unpacking the Unit Carefully unpack your ART MI unit and verify that all components and accessories are included Figure 1 All components and accessories Item Quantity Item Quantity 1 Main Unit 1 2 Foot Control Foot Switch 1 3 AC Power Cord Set 1 4 PU Water Tubing 1 5 User Manual amp Literature Packet 1 6 ART IF 50 Streamline Universal Plastic Handle Internal Flow Insert Optional ART P 10 Straight Angle Universal Metal Handle External Flow Insert Optional 7 Water Hose Quick Disconnect Assembly Optional NOTE While unpacking check your ART M1 unit for any damages If any damages are found please contact your dealer immediately Enter the unit serial number on your warranty card and mail it within 14 days from the date of purchase 5 E Power Cord Power Connection e Always make sure that the power switch is set to the OFF position before performing the following tasks o Plug the detachable AC cord into the back of the unit o Plug the 3 prong plug into a grounded outlet 42 A N Safety Instructions A Grounding Prior to connecting accessories to the unit check that th
5. procedures WARNING Alerts users of danger that may cause severe injury when proper procedures are not followed e SYMBOLS e Compliance with MDD 93 42 EEC 0434 BF equipment Grounding terminal Attention Please read instructions gt B Warnings Important Only trained and qualified doctors dentist and hygienists should operate the ART M1 Patients with pacemakers cannot be treated with the ART M1 v wv Do not immerse the ART MI in water gt If patient or operator is pregnant consult a physician prior to performing dental scaling for safety purposes The ART M1 requires a shielded AC power cord Plug the power cord into a well grounded outlet v AN Attention to users with cardiac pacemakers Patients with pacemakers should avoid treatment with the ART M1 Electronic appliances including razors hair dryers microwave ovens TV receptors and other medical equipment such as the ART MI may interfere with the performance of pacemakers For more information on this subject please refer to the following articles Advances in Cardiac Pacemaker The New York Academy of Sciences Vol 167 Article 2 pp 515 1075 Electromagnetic Radiation Interference with Cardiac Pacemaker U S Department of Health Education and Welfare The Individual with a Pacemaker in the Dental Environment Journal of the American Dental Association Vol 91 No 6 pp 1224 1229 Please Read Bef
6. see figure below 4 During treatment try to keep the angle between the surface of the tooth and scaling insert at 15 degrees If the patient experiences any discomfort during treatment follow the suggestions below e Increase the hand piece movement speed on the surface when treating sensitive areas e Treat less sensitive area first and then return to sensitive areas e Ifthe problem persists reduce the power output intensity of the hand piece Section VIII System Maintenance Daily start up 1 Open the water supply valve 2 Turn the ART MI on using the main power switch Verify that the LED power indicator LED is lit 3 Set the power control knob to full power 4 Turn the water control knob to the maximum setting 5 Hold the empty hand piece upright over a sink or drain 6 Depress the footswitch and flush the water line for at least 2 minutes 7 Place a Bonart scaling insert or a compatible insert into the hand piece and adjust the water level as desired NOTE If no water is detected check the water supply NOTE If the power LED is not lit contact a local authorized agent 18 Preparations for treating each patient 1 Remove clean and sterilize all used ultrasonic inserts 2 Make sure the scaling insert tip has been sterilized before treating the next patient 3 Clean and disinfect the surface of the power cord hand piece and cable assembly Daily shutdown 1 Use the power switch to turn th
7. 230V 5 50 60Hz 92VA 24 5KHz 5 for 25KHz Insert 25 60 PSIG 172 414KPa 24 5cm L x 22 5cm W x 8 5cm H 4 Kg include hand piece 250 cm 250 cm 0 60 10 90 non condensing 0 60 10 90 non condensing 860 1060 hPa Please follow county and state regulations for disposal of the ART M1 21
8. ART M1 Magnetostrictive Ultrasonic Scaler Instruction Manual ias Bonart Co Ltd Jorgen Kruuse A S 4F 11 No 3 Wuquan Ist Rd Xinzhuang Havretoften 4 DK 5550 Langeskov Dist New Taipei City 24892 Taiwan R O C Denmark Tel 886 2 22983980 Fax 886 2 22983981 C w 0434 Email sales bonartmed com COPYRIGHTO 2013 BONART CO LTD BONART Co Ltd owns all rights to this publication This publication shall be used solely as a reference for operation maintenance and repair on BONART equipment No part of this document may be reproduced or distributed in any form for any other purpose In the event of inadvertent or deliberate publication BONART intends to enforce its rights to this manual under the copyright law Reproduction of the materials presented in this manual without the express written permission of BONART Co Ltd is prohibited The contents of this manual are subject to change without prior notice PROPERTY OF BONART CO LTD ALL RIGHTS RESERVED ART is a registered trademark of BONART Co Ltd amp its affiliates Document No RD 02 01 02 Rev 1 1 07 12 Printed in Taiwan R O C Operator Safety Please read this manual before operating unit The ART M1 magnetostrictive ultrasonic scaler should be operated maintained and repaired by qualified and properly trained personnel e NOTE CAUTION AND WARNING STATEMENTS NOTE Provides tips and advice CAUTION Provides correct operating or maintenance
9. ars Do not repeatedly tap or hold the footswitch down The empty hand piece will melt Lubricate the rubber O ring on the insert with water before placing it into the hand piece To install the insert firmly push the insert into the hand piece Hold the hand piece over a sink or drain with an insert installed Verify that the water is reaching the tip Check your Bonart scaling inserts for wear and replace as needed Use the foot control to control the water flow to the hand piece Hold down the foot control to allow water to flow through Release the foot control to stop the water flow Adjust the water flow using the water control knob to the desired level of water flow and hand piece temperature Increase the water flow by turning the water control knob clockwise Decrease the water flow by turning the water control knob counter clockwise NOTE Increased water flow results in a cooler hand piece temperature and vice versa CAUTION During operation a continuous flow of water is required to keep the hand piece cool 17 Z B Patient Comfort Considerations Position the patient comfortably on the patient chair Adjust the chair angle and position to access the patient s oral cavity with ease and comfort 2 Put the saliva ejector into the patient s mouth to remove excess saliva and debris 3 Rotate the patient s head gently so that the oral cavity can be easily accessed without causing discomfort to the patient
10. ately Use the long axis of the scaling tip insert to wipe accretions from the tooth Do not gouge the tooth with the tip 3 C Precautions for hand piece In order for the system s hand piece to function consistently and effectively Accumulated air pressure from the handle or hand piece must be released every 10 to 15 minutes on every procedure by doing the following steps 1 Put the insert into the hand piece and make sure it is fully seated 2 Hold the hand piece vertically with the insert tip on top depress the foot Switch control 3 Let the water spray out for a minute or so then start scaling procedure Section IV Infection Control 4 A General Infection Control Recommendations As with all dental procedures use standard protective equipment such as face masks eyewear face shields gloves and protective gowns To ensure safety to the operator and patient carefully follow the Infection Control Procedures detailed in Section XII 4 B Water Supply Recommendations All dental water supply systems should conform to applicable Centers for Disease Control and Prevention CDC and the American Dental Association ADA standards These standards should apply to flushing chemical flushing and general infection control procedures 4 C Cleaning and Sterilization Hand piece Prior to cleaning remove the insert from the hand piece Next drain any water left in the hand piece to clear the hand piece of any residu
11. e ART M1 off 2 Close the water supply valve Daily Maintenance The suggestions below will help maximize the lifespan of the scaler A The ART MI should be used in a well ventilated room B Handle the ART MI with care when moving it C Before leaving the operation room make sure that the ART M1 is turned off and the water faucet is tightly closed D If you find that the power output to the hand piece is insufficient the insert is probably worn out Inserts should typically be replaced after six months or when worn out E If service is needed please contact a local authorized agent for technical support Section IX Troubleshooting While Bonart offers repair service the following trouble shooting procedures can help you save time 9 A Troubleshooting Guide Basic procedures 1 Check all lines and connections to and from the system A A loose plug or connection is the most common cause of problems 2 Check the setting of all control knobs System will not operate LED power indicator is not lit 1 Check that the power control switch is in the ON position and that the detachable power cord is fully seated in the receptacle on back of the system 2 Check that the three prong power plug is fully seated in the AC receptacle on the back of the ART M1 and that the voltage is supported 19 3 Check that the power plug is plugged into the wall outlet LED power indicator is lit 1 Check that the footswitch connect
12. e accumulated during treatment Then clean the surface of the hand piece with antiseptic soap or solution and rinse thoroughly with water Afterwards wipe or spray a chemical disinfectant on the hand piece Please try to use a disinfectant that has a 1 6 dilute solution ie Sporicidin Disinfectant to avoid damaging the hand piece After disinfecting the hand piece a sterile insert may be re inserted into the hand piece in preparation for the next patient At the end of the day remove the insert from the hand piece and scrub both the hand piece and cable with antiseptic soap Rinse thoroughly with water NOTE Cleaning the hand piece after every patient is advised WARNING Do not dip the hand piece and extension cable directly into the sterilized fluid Doing so will cause the ART M1 to malfunction WARNING Do not leave the disinfectant on the surface of the hand piece and extension cable any longer than instructed by the manufacturer of the disinfectant Insert Saliva blood and other debris will leave a residue on the insert after each use Therefore it is necessary to clean inserts after each use Cleaning can be done manually by scrubbing the insert with a brush water and detergent Be sure to rinse thoroughly after scrubbing Let the insert dry Then place the insert in a bag and autoclave at 275 F 135 C for 15 minutes or as recommended by the manufacturer of your sterilization unit to sterilize the insert Bio
13. e hand piece to melt NOTE The ART M1 is a stand alone unit and is now only available in 25Khz Please do not use 30Khz inserts with the hand piece Footswitch The footswitch is designed to allow the operator to use two hands while scaling Main power switch ON OFF The main power switch turns the ART M1 unit on and off When the power is switched on the LED power indicator on the main unit should be lit When the power is switched off the LED power indicator should be unlit AN Make sure the footswitch is in the OFF position before turning on the ART M1 15 5 Turbo switch The turbo switch allows you to switch between turbo and scaling mode Pushing the button once during scaling mode will trigger turbo mode and light the LED mode indicator Under turbo mode power output increases to make cleaning easier To return to scaling mode push the turbo switch button again The LED mode indicator should diminish 6 Water control The water control knob adjusts the amount of water flowing through the hand piece To increase the water flow turn the knob clockwise To decrease the water flow turn the knob counter clockwise Keep in the mind that the water level should be adjusted not only for cleaning tartar but also for cooling the hand piece during use Increasing the water level will cool the hand piece faster WARNING Do not turn the water knob counter clockwise more than three full turns Doing so will damage the in
14. e main unit is plugged into a grounded wall outlet B Main voltage range and fuse Prior to plugging the AC adapter into the power outlet check that the voltage is supported 5 F Foot Control Cable Assembly Connection Align the pins of the foot control plug with the receptacle on the back of the device and push in until the plug is firmly seated 5 G Water Supply Line Connection Push the blue water tube hose into the stainless steel receptacle until the hose cannot be pushed any further Then tighten the screw Connect the quick connect to the water supply line The ART MI should be prepackaged with a male quick connect If a female quick connect is necessary please contact a Bonart distributor to purchase the part Inspect all connections for leaks To remove the water line from the ART M1 scaler first turn off the water supply or disconnect the water supply line Then loosen the screw on the water tube from the receptacle of the unit and gently pull the water hose out 5 H Hand piece Cable Assembly Connection The ART M1 hand piece attached to the main unit is designed only for inserts with a frequency of 25khz The ART MI is not available in 30khz so please do not try using a 30khz insert with the ART MI 219 5 I Assembling the Scaler Unit 1 Switch the power of the ART M1 off The power indicator should not be lit if the machine is off 2 Plug the power cord of the main unit into a grounded AC power outlet 3
15. minum plates to become more familiar with the scaling tips before performing on patients Table of Contents Copyright C 7 Quisih pO h utu ias Operator Safety ee rere CU Rae erty ade Warnings shpat Sadun ee a Swed ev ds Prefage i Rear wR ell be a ee Contents RNE NR Peer Tar section Indications Tor Use gt deduce eot eei evel Section II Contraindications and Warnings Section II Precautions eei eere e erede ees Section IV Infection Control 2525 IA Section V Installation quest eecpees dote v Et REESE YE RE SER te s pXaEEER Section VI General Description and Information of Parts Section VIL Techniques j weit tasse rex vea t veta Section VIII System Maintenance Section IX Troubleshooting 22252eeemI Section X Specifications a vL eD o Section XL Disposal desee o eed as Section I Indications for Use Ultrasonic procedures Removal of calculus and plaque during dental prophylaxis General supra and sub gingival scaling applications Periodontal debridement for all types of periodontal diseases Endodontic procedures Section II Contraindications and Warnings Do not use the ART MI for amalgam restorative dental procedures Do not use the ART MI if the patient or operator is wearing a pacemaker
16. or is fully seated in the foot control receptacle on the back of the system System operates No water reaches the tip Ensure that the water control knob is turned on or adjusted to allow water to flow 2 Check that water supply control valve s dental office water supply is open 3 Check that the external water tube is properly connected 9 B Technical Support and Repairs For technical support and assistance call 1 888 526 6278 or 626 600 5330 Monday through Friday 9 00 AM to 5 00 PM Pacific Time For other areas contact your local Bonart representative X Specifications Classification Protection against electric shock Class I Degree of protection against electric shock Type BF Mode of operation Continuous e Medical device directive Ha Standards Followed 18013485 Medical Devices Quality Management Systems Requirements for regulatory purposes 93 42 EEC MDD CE Directive EN60601 1 Medical Electrical Equipment General Requirement for Safety EN60601 1 2 Medical Electrical Equipment Electromagnetic Compatibility Requirements and Tests 20 Specifications e Power supply e Working frequency e Water supply e Dimension e Weight e Hand piece Cable e Footswitch Cable Operation environment e Temperature e Relative Humidity Transportation and Storage conditions e Temperature e Relative Humidity e Atmospheric pressure Section XI Disposal 115V 5 50 60Hz 92VA
17. ore Operating Make sure the device is connected to a grounded outlet Failure to meet this requirement may severely damage the user and equipment Place the device on a flat and stable surface Placing the device on a tilted or unstable surface may degrade performance and also cause damage to the device Do not modify this device Modifications to the device will invalidate the safety codes and warranty while endangering the patient and operator Do not place heavy objects on top of the power cord and keep the power cord away from intense heat Unplug the device and call Bonart for service and instructions if you observe any abnormalities while operating the device Preface About the ART M1 Magnetostrictive Ultrasonic Scaler The ART MI Magnetic Ultrasonic Scaler is manufactured by Bonart Co Ltd an ISO 13485 2003 company The ART MI is also CE 0434 certified in compliance with the applicable requirements of the Council Directive 93 42 EEC The reviewing council also classifies the ART M1 in accordance with EN60601 1 and ENO0601 1 2 safety requirements How it works The ART M1 consists of two parts The main electronic system and the scaling hand piece The main electronic system utilizes two closed loops One loop provides automatic tuning to match the resonance of the insert The other loop will control the tip stroke based on various working conditions The scaling hand piece utilizes a
18. pulsing magnetic field This magnetic field is applied to a metal stack which flexes and moves an installed scaling tip insert approximately 25 000 30 000 cycles per second in an elliptical pattern based on the amount of power used Thus more power results in greater tip displacement which allows for more robust scaling However the vibrating metal stack generates heat and requires adequate amounts of fluid to cool the hand piece and tissues during treatment When the two parts of the ART MI are placed together the properties of the main unit and scaling hand piece enable the ART M1 to power away the heaviest calculus deposits In addition tips may be rotated 360 degrees within the hand piece to relieve cord tension and alignment As a result the ART MI provides maximum comfort to the patient and ease of use to the operator Technical Support For technical support and repairs in the U S call 1 888 526 6278 or 626 600 5330 Monday through Friday 9 00 AM to 5 00 PM Pacific Time For other areas contact your local Bonart representative Supplies amp Replacement Parts To order supplies or replacement parts in the U S please contact one of our authorized distributors listed on our website www bonartmed com CAUTION Since the scaling tip insert is made of stainless steel avoid direct contact with teeth Direct contact will cause damage to teeth enamel For optimum performance we suggest practicing on a model or alu
19. ternal water line needle WARNING If needed gently adjust the water control knob to prevent any serious damages to the water valve When used for the first time turn the knob clockwise to allow N water to flow through The knob is set to the off position when assembled by the manufacturer 7 Power control The power control adjusts the power intensity to the desired level based on the cleaning procedure When turned clockwise power output increases When turned counter clockwise power output decreases 8 Water in Connector The water in connector is the contact point for the water tube and the main water supply line Use either a male or female quick connect to connect the water tube to the water supply The ART MI comes with a male quick connect attached to the water tube 9 AC Line Socket Seat The AC line socket seat is the connection point between the power cord and the main unit 16 Section VII Techniques Z A Performing Ultrasonic Scaling Procedures l Use purified or distilled water to prevent infection when patients experience tissue laceration during treatment Keep the power cord tidy to avoid tripping and other accidents Position the footswitch in an easily accessible spot for the user Keep the footswitch cord tidy to avoid tripping and other accidents Hold the empty hand piece in an up right position when testing to see if the scaler is working properly Tap the footswitch until water appe
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