Directions For Use - Dentsply International
Contents
1. Follow the following instructions to install the device Connect Power Supply WARNING Use only the Midwest E motor and power supply supplied with the Midwest E Electric Handpiece System To connect the AC Power Adaptor 1 Connect the power supply cord to the back of the control unit as shown in Figure 4 below 2 Connect the power supply adaptor to the mains cable 3 Plug the AC mains cable into a 120 VAC wall outlet NOTE Maintain a clear path to the back of the control unit when mounting the device to the dental unit such that disconnection of the power line is still accessible Electric Handpiece System 4 Installation and Preparation for Use Figure 4 Connect Power Supply Connect Drive Air Tubing to the Control Unit Connect the 4 hole 5 hole or 6 pin air and water supply tubing according ISO 9168 to the four hole connection of the control unit See Figure 5 below l CAUTION Compressed air supply must be clean dry and free from oil per ISO 7494 2 A filter water trap or a air dryer may be required Failure to adhere may damage the motor or attachments of the device To prevent damage to the device adhere to all pressure specifications as described in Chapter 12 Technical Specifications The specified pressure into the control unit must be between 3 5 4 0 bar 50 8 to 58 psi Figure 5 Connect Tubing to the Control Unit Electric Handpiece System 4 Installation and P2. ENDO mode 2 Pressing the and icons will toggle the time 1 to 5 Seconds reverse time 3 Confirm the desired reverse time by pressing the AUTO REVERSE FORWARD TIME icon again The saved value will appear inside the icon To Adjust the Display Contrast or Brightness 9 1 Pressing the CONTRAST BRIGHTNESS icon will activate the setting menu to change the contrast brightness of the LCD screen 2 Pressing and holding the and icons will toggle the contrast 3 Confirm by pressing the CONTRAST BRIGHTNESS icon again Electric Handpiece System 5 Set Up Mode To Adjust Standby Mode 9 The standby mode switches off the display if the control is not active during the set time By setting 0 the standby mode is switched off By activating the foot control or touching the display the display will wake up and all functions will be available 1 Press the STANDBY TIME icon to enter the standby menu 2 Pressing the and icons will toggle the time to enter standby mode Possible settings include 0 to 90 minutes in steps of 5 minutes 3 Press the STANDY TIME icon again to confirm your choice To Adjust the Additional Gear Memory Settings A or B O 1 Press one of the GEAR SETTINGS icons icon A or B to enter into the additional gear settings memory menu 2 With the or icons select the desired Gear Setting ratio desired 3 Press the GEAR SETTINGS icon again to confirm the setting 4 R
3. communication device as indicated below Rated power of the Safe distance depending on the transmission frequency m For transmitters whose maximum rated power is not in the above table the recommended safe distance d in meters m can be calculated using the equation for the respective gap where P is the maximum rated power of the transmitter in Watts W according to the manufacturer s information NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not be applicable in every case The spread of electromagnetic waves is absorbed and reflected by buildings objects and people MIDWEST Electric Handpiece System 12 Specifications Control Unit Motor speed range forward reverse Output torque Motor current Motor voltage Operation mode Current of LED Air outlet of the coupling cooling air Spray air pressure Spray water pressure Weight Dimensions Width Height Depth Rotation Sound level Instrument connection Protection class Overvoltage category Pollution degree Device classification of applied part EN 60601 Protection category Power Supply Rated voltage Rated frequency Power consumption Operation mode Weight Dimensions Width Height Depth Protection class Overvoltage category Pollution degree Protection category Requirements to Control Unit System pressure Spray air Spray water Cooling air
4. icon will return to the picture shown on the right PSIBAR 8 The Foot Control is now calibrated Once the foot control has been calibrated the product is ready for use Page 16 Electric Handpiece System 5 Set Up Mode To Turn ON OFF Speaker Sound 8 1 Pressing the SPEAKER icon changes the operating status of the speaker 2 Ifthe icon has a slash through it the speaker it is off no slash indicates the speaker is on To Adjust the Fiber Optic Handpiece Light Time Delay 6 1 Pressing the FIBER OPTIC DELAY icon will activate the setting menu to change the delay time of the handpiece fiber optic light 2 Pressing the and icons will toggle the time delay from 1 to 5 seconds delay time 3 Confirm the desired delay time by pressing the FIBER OPTIC DELAY icon again The saved value will appear at the bottom right of the icon To Adjust the Hand Piece Light 4 1 Pressing the HANDPIECE LIGHT icon will activate the Handpiece light menu to adjust the handpiece light intensity 2 Pressing the and icons will toggle light intensity 3 Confirm the desired setting by pressing the HANDPIECE LIGHT icon again The saved value will appear inside the icon To Adjust the Auto Reverse Forward Time during Reverse 2 1 Pressingthe AUTO REVERSE FORWARD TIME icon will activate the setting menu to change the reverse time The device will go reverse for T amount of time for the auto reverse forward feature in
5. of the auto reverse option for endodontic procedures by pressing the TORQUE STOP MODE icon 16 Continue to press the TORQUE STOP MODE icon until The desired direction option is displayed The choices will be Auto Stop Auto Reverse Auto Reverse Forward See time value set up in the Set Up Mode page 15 Torque Stop Mode allows the user to define the response of the system when the specified torque is reached on the endodontic file Auto Stop When the specified torque value is reached on the endodontic file the handpiece will stop Auto Reverse When the specified torque value is reached on the endodontic file the handpiece will reverse in direction until the user releases the foot pedal Auto Reverse Forward When the specified torque value is reached on the endodontic file the handpiece will reverse in direction for the specified time and then return to normal forward rotation NOTE The torque value determines the point at which the direction of rotation will stop in Auto stop or reverse in direction when in Auto reverse or Auto reverse forward Storing Settings in Memory O 17 Pressing the E1 button and holding it in until the signal sounds stores the options set in menu option E1 18 Follow the same procedure for setting E2 E3 and E4 if desired Electric Handpiece System 9 Cleaning and Maintenance Cleaning The motor and attachments MUST be cleaned and sterilized after each patient use refe
6. up CALIBRATION Calibration of foot control working pressure Submenu in the Set up SPEAKER Speaker on off Submenu in the Set up Audio CONTRAST BRIGHTNESS Display contrast brightness setting Submenu in the Set up Change parameter values Submenu and main menu DOWN Change parameter values Submenu and main menu DIRECTION OF ROTATION Direction of rotation Main menu of the handpiece bur file AUTO STOP Torque Stop Mode Main menu E1 to E5 Auto Stop Endodontic mode AUTO REVERSE Torque Stop Mode Main menu E1 to E5 Auto Reverse Endodontic mode Tem AUTO REVERSE Torque Stop Mode Main menu E1 to E5 FORWARD Auto Reverse Forward Endodontic mode Electric Handpiece System 4 Installation and Preparation for Use Button ss icon Name Function Mode 200 SPEED Bur speed Main menu E1 to E5 O00 and P1 to P3 RPM BE y GEAR RATIO Ratio setting of the low speed Main menu E1 to E5 attachments and P1 to P3 Hyt E1 E2 E3 E4 Memory cell for Main menu Endodontic mode to E1 E2 E3 E4 P1 P2 P3 P4 Memory cell for preparation to Main menu P1 P2 P3 P4 04 TORQUE Torque value setting Main menu E1 to E5 DEMO Demonstration of motor rotation Set up menu without air connection O START Start motor Demonstration mode STOP Stop motor Demonstration mode SERVICE Service menu Set up menu for service technician ONLY FACTORY RESET Factory settings Set up men
7. MIDWEST Electric Handpiece System Directions for Use CAUTION US Federal law restricts this device to sale by or on the order of a licensed dental professional MIDWEST Electric Handpiece System Doc No 87514 0914 Table of Contenis Ti MAroOdUCUON ie crim a e ie ci aa te cane 2 Important Information eee Indications for USe ee seaca coate za pia ata editie agata eat ae cit Contraindications e eee nnaaa WV CUBIS sor ie ez ses ee sees Sas tamil ae 0 iata ea i aut es Precautions anoeie ees nacged a dai nani ai ao Adverse Reaccions scz adela ceia ei e a ari du e nai a Applied SymbOIS satui tite naut one e Dle ela nn 3 PRODUCE OVEIVIGW ace as caiete ac aaa aia ata st Overview OF th UNI cope aaa ac ca a ata ta ni al Back Panel iai sina i jones E il aie 4 Installation and Preparation for Use eeeei LOG AN op RPR ean alec G se a a S WUT UU ALO Miss oi i ce cals heehee cece tase ne ala setat Otel adu a System ICONS act coace ii Doe a a ca eee uita 5 SEL UD MOOS sis aie atacate a omagiat e it beaaa Set Up Mode Operations e eee eee Calibration teo e ne eee tocat aia At a ai ud aaa i E beau 6 General Op rati N s moca eo aerieni aaa a nodal General Operation n i enaaa Operational Mode Options cc eee eeeaae 7 Preparation Mode eee All trademarks referred to are the property of their respective owners Manufactured for DENTSPLY Professi
8. SM than the recommenced safe distance calculated using the bands equation for the transmission frequency Recommended safe distance Radiated HF disturbances 3 V m d 0 50 VP IEC 61000 4 3 80 MHz to 2 5 GHz d 0 35 VP for 80 MHz to 800 MHz d 0 70 VP for 800 MHz to 2 5 GHz with P as the maximum rated power of the transmitter in Watts W according to the transmitter manufacturer and d as the recommended safe distance in meters m gt The field strength of stationary radio transmitters should be less than the conformance level at all frequencies in an on site check Disturbances are possible close to devices that have the following symbol 4 MIDWESTE Electric Handpiece System 11 Information on Electromagnetic Compatibility NOTE Ur is the alternating mains voltage before the test level is used NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not be applicable in every case The spread of electromagnetic waves is absorbed and reflected by buildings objects and people The ISM frequency bands for industrial scientific and medical applications between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHZ to 27 283 MHz and 40 66 MHz to 40 70 MHz P The conformance levels in the ISM frequency bands between 150 kHz and 80 MHz and the frequency range of 80 MHz and 2 5 GHz are intended to reduce the probability that mobile and portable communicat
9. al injury Never remove the cover of the device and never insert objects through the holes or openings on the case Non compliance may cause damage to the device and or may endanger the user Electric Handpiece System 3 Product Overview Overview of the Unit HQQeeee Figure 1 Overview of the Unit LCD Screen Control Unit Midwest E Motor Power Supply Unii Power Supply Main Cord Motor Hose Installation Bracket Electric Handpiece System 3 Product Overview Back Panel 1 4 hole 5 hole or 6 pin Connector 2 Power Supply Input 3 Motor Hose Input Electric Handpiece System 4 Installation and Preparation for Use A WARNING Installation of the device should be performed by a qualified service technician only Location A mounting accessory is supplied with the unit to aid installation of the system to a dental unit The placement and mounting location of the device is at the discretion of the dental office To mount the controller e Attach the supplied controller mounting bracket in the desired location The bracket contains four holes on the surface wings to easily bolt it to the underside of a dental unit tray Mounting Bracket e Slide the controller unit into the bracket e Using the four screws and washers supplied mount the unit to the bracket by aligning the four slots on the bracket base with the four holes on the bottom of the control unit Installation
10. d in Preparation Mode Operations on page 20 e Endodontic Mode ENDO For performing Endodontic Procedures information on operating instructions using ENDO mode can be found in Endodontic Mode Operations on page 22 e Set Up Mode SETUP Allows user to change various settings on the device information on operating instructions under the SETUP mode can be found in Set Up Mode Operations on page 15 Electric Handpiece System 7 Preparation Mode Preparation Mode Operations Preparation Mode PREP allows the user to regulate the motor speed direction and light source on off of the handpiece system The Midwest E provides 4 default Memory Settings for ratio and speed for details see the default values table for ratio and speed in Table 1 below To individually change these settings simply overwrite them as described below This allows one to compile their own preferences to fit their option needs Preparation Mode PREP Mode Icon PREP 200 I 000 f 2 SPEED Icon co ll HANDPIECE LIGHT Icon TANE B DIRECTION OF ROTATION Icons SET GEAR RATIO Icon 6 PREP MODE MEMORY SETTING Icons Parameter Icons Table 1 PREP Mode Factory Settings 200 000 rom PREP Mode allows each user to change the following settings Gear Ratio Rotary Speed 2 Direction of rotation clockwise or counter clockwise Light on off To Change PREP Mode Memory Settings 1 Turn on the device 2 P
11. dodontic Mode presets 3 Press E1 E2 E3 or E4 icon to view and edit the settings when activated the background becomes highlighted Change Gear Ratio 4 Activate the gear ratio settings by pressing the GEAR RATIO icon Select the appropriate increase or reduction ratio using the or icons 5 Confirm the gear ratio by pressing the GEAR RATIO icon again Change Speed 2 6 Activate the speed by pressing the SPEED icon 3 when activated the background becomes highlighted 00 7 Change the speed using the or displayed icons until the speed desired is 8 Confirm by pressing the SPEED icon again the color of the icon will RPM return back to its original state Change Torque Preference 9 Select the torque by pressing the TORQUE icon The icon will show the active status by becomes highlighted He bo 10 Select the appropriate torque value using the or icons 11 Confirm by pressing the TORQUE icon again Change Direction of Rotation 4 12 Select the direction of motor rotation by pressing the DIRECTION OF ROTATION icon O 13 The arrow on the icon illustrates the direction of rotation i e clockwise or counter clockwise when the rotary instrument is facing away from the user 14 During counter clockwise rotation the Torque Mode is not activated flashed out Electric Handpiece System 8 Endodontic Mode Change Torque Stop Mode 3 15 Select the direction
12. enerate strong radio frequency interference RFI The functions of implanted systems such as pacemakers can be influenced by electromagnetic fields Inform patients of the risks before starting treatment Use of damaged Edondontic files or Burs Use of damaged Endondontic files or Burs can result in personal injury or damage to the product Stop using the device immediately in the event of damage irregular running noises excessive vibrations unusual generation of heat or if the drill bit is not firmly gripped Only Use Approved Files and Burs Unauthorized file systems can result in personal injury or damage to the product o Only use authorized Ni Ti file systems with a consistency of gt 2 suitable for rotary systems o Only use files with shafts meeting the requirements of ISO 1797 2 ISO 3630 1 and ISO 3630 2 with a shaft diameter of 0 092 to 0 093 inches Service Using Authorized Personnel Only Supply of spare parts service and maintenance of the Midwest E Electric Handpiece System is restricted to DENTSPLY authorized service personnel only Use of other servicing or non qualified paris is prohibited NOTE Send the product every 3 years for a service check The safety check according to IEC 62353 and the measurement check will be carried out during service check The safety checks in different countries can vary in compliance with country specific regulations and requirements for medical devices The national valid regulations a
13. epeat the same procedure above for Gear Ratio B To Reset Factory Settings 2 All manual settings can be re activated to the factory settings by pressing the FACT SET icon button and holding until it beeps NOTE All manual settings will be cancelled when this button is pressed Service Menu This icon is for use by Authorized Service Technicians Only To Enter Demo Mode 2 WARNING Never use Demo Mode for patient treatment 1 To enter Demo Mode select the DEMO icon 2 The screen will jump to the last previous program used 3 Press the START button to start the test The motor will start running and continue to run for a maximum of 2 minutes 4 The running cycle of the motor can be interrupted by pressing the V STOP icon 5 When the test is done press DEMO icon or SETUP icon and the screen will go back to the previous menu or SETUP menu Page 18 Electric Handpiece System 6 General Operation General Operation WARNING 4b To Promote Infection Control Always adhere to protective measures when handling the device with patients After use with a patient spray air and water through the device for at least 20 seconds After prolonged storage of the device first flush water and air lines to remove any stagnation that occurred during storage Handpiece attachments and motors should be sterilized between patients Sterilize both handpiece attachments and motors before use both are supplied no
14. g Maximum Foot Pressure 4 Atthis time MAX will be displayed on the top left of the icon if MAX is not already displayed on the Calibration Icon continue to press the icon until MAX is displayed on the Calibration Icon NOTE When MAX is displayed the unit is ready to calibrate the maximum pressure from the foot pedal 5 While pressing and holding the foot control all the way down Press and Hold the CALIBRATION icon until a signal sounds Once a sound is heard maximum pressure has now been calibrated to equal 100 After the signal sounds the system will automatically change the icon to MIN meaning the system is ready to calibrate the minimum pressure NOTE To calibrate the MAX pressure again simply toggle the CALIBRATION back to MAX and repeat step 5 Calibrating Minimum Foot Pressure 6 The CALIBRATION icon should now have MIN displayed on it If it is not displayed then continue to press the CALIBRATION icon until MIN is displayed on the CALIBRATION icon NOTE When MIN is displayed on the CALIBRATION icon the unit is ready to calibrate the minimal pressure 7 With your foot completely off the foot control press and hold the CALIBRATION icon until a signal sounds Once a sound is heard minimum pressure has now been calibrated to equal 0 The system will automatically save the values and exit the calibration mode a once the minimum calibration value has been set The CALIBRATION
15. g or stop options of the handpiece system The combination of the torque and Torque Stop Mode options in Endodontic Mode allows the user to designate the motor torque limits and direct the motor into auto reverse once the specified torque limit is reached The Midwest E provides 4 default Memory Settings for ratio soeed torque and direction for details see the default values table for ratio speed and torque in Table 3 below To individually change these settings simply overwrite them as described below This allows one to compile their own preferences to fit their option needs NOTE In Endodontic Mode the light source is set to ON for all presets 3 Endodontic Mode ENDO Mode Icon TORQUE STOP MODE Icon 4 DIRECTION OF ROTATION Icon GEAR RATIO Icon TORQUE SETTING Icon 7 ENDO MODE MEMORY SETTINGS Icon Parameter Icons Figure 10 Endodontic Mode Menu Screen Ratio Direction of Table 3 ENDO Mode Factory Settings ENDO Mode allows each user to change the following settings Gear Ratio Rotary Speed 2 Direction of rotation Torque Stop Mode Auto Stop Auto Reverse Auto Reverse Forward 3 Torque limit Electric Handpiece System 8 Endodontic Mode l CAUTION When using ENDO Mode the spray air and spray water must be switched OFF at the dental unit m or foot control To Change ENDO Mode Memory Settings 1 Turn on the device 2 Press ENDO to access the En
16. ions equipment will produce disturbances when they are unintentionally brought near the patient For this reason the additional factor of 10 3 is used when calculating the recommended safe distances within these frequency ranges The field strength of stationary transmitters such as base stations of mobile telephones and land mobile radio devices amateur radio stations AM and FM radio and television broadcasters cannot be theoretically predetermined To determine the electromagnetic environment of stationary transmitters a study of the location should be considered When the measured field strength at the site where the medical device is used exceeds the above conformance level the medical device should be monitored to demonstrate proper function When unusual performance features are observed additional measures may be necessary such as realigning or moving the medical device d Within the frequency range of 150 kHz to 80 MHz the field strength should be less than 3 Ver V m Recommended safe distance between portable and mobile HF telecommunications equipment and the medical device The medical device is intended for use in an electromagnetic environment in which HF disturbances are controlled The customer or the user of the medical device can help prevent electromagnetic disturbances by maintaining the minimum distance between portable and mobile HF telecommunications devices transmitters and the medical device depending on the output of the
17. l 2 kV for power lines 2 kV for power lines The quality of the supply voltage should disturbances Bursts 1 kV for signal lines 1 kV for signal lines correspond to that of a typical business or hospital IEC 61000 4 4 environment Surges 1 kV push pull voltage 1 kV push pull voltage The quality of the supply voltage should IEC 61000 4 5 2 kV common mode 2 kV common mode correspond to that of a typical business or hospital voltage voltage environment Voltage interruptions lt 5 Ur for 0 5 periods lt 5 Ur for 0 5 periods The quality of the supply voltage should short term interruptions 40 Ur for 5 periods 40 Ur for 5 periods correspond to that of a typical business or hospital and fluctuations of the 70 Ur for 25 periods 70 Ur for 25 periods environment When the user of the medical device supply voltage lt 5 U for 250 periods lt 5 U for 250 periods needs continued operation even when the power IEC 61000 4 11 supply is interrupted it is recommended to supply the medical device from an uninterrupted power supply or a battery Magnetic field with a supply 3 A m 3 A m Power frequency magnetic fields should be at frequency 50 60 Hz per levels characteristic of a typical location ina IEC 61000 4 8 typical commercial hospital Conducted HF disturbances 3 Vert Portable and mobile radio devices should not be used IEC 61000 4 6 150 kHz to 80 MHz closer to the medical device including the electrical lines outside of the I
18. n sterile Follow all cleaning and maintenance procedures as described in the Cleaning and Mainenance Section 9 of this manual for the control unit and hoses A Always Confirm Safe and Accurate Device Operation by A Confirming all inout values before use including motor speed in relation to the appropriate handpiece attached torque limits and drill direction Monitoring device operation during use Stop using the device immediately in the event of damage irregular running noises excessive vibrations unusual generation of heat or if the rotary instrument is not firmly gripped Ensuring the motor is running at the desired speed by pressing down on the foot control for 2 seconds before starting the procedure to allow the device to reach its target speed Confirming device is not in Demo Mode Never use Demo Mode for patient treatment The Midwest E Electric Handpiece System is not intended to replace proper clinical judgment Dentists and associated assistants should always adhere to their local standard operating procedures and ensure the device is working as intended prior to use MIDWEST Electric Handpiece System 6 General Operation Operational Mode Options The Midwest E Electric Handpiece System provides two operational Modes and one Set Up Mode for procedural use e Preparation Mode PREP For general preparation Non Endodontic Procedures information on Operating Instructions using PREP mode can be foun
19. onal A division of DENTSPLY International 901 West Oakton Street Des Plaines IL 60018 1843 USA www denisply com Preparation Mode Operations ccccccsssseeeeeeeeeeeeaeeeees 21 8 Endodontic Mode eee eee 23 Endodontic Mode Operations eee 23 9 Cleaning and Maintenance 26 CVS NING sita sia a aaa de aia tees valine Da Dc Seti 26 Mantenan G ee secarei dt a dc a Sado ana 3 a 26 10 Troubleshooting aiani aice econo dee caii Doi sat 27 11 Information on Electromagnetic Compatibility 28 TZ SCC INCA ONS cico azateabee seta setea a alu 30 CORNI O Unt conice ana aaa da zi a act a ua aleea a 30 Power SUD IV ce ace noieii ae eee a o 30 Requirements to Control Unit eee 30 Recommended Input Settings cccccccsseeeeeeeeeeeeeeeeees 31 Operating Conditions of Control Unit and Power Supply 31 TVDELaDel ses se iaca a aia dat el lea 50 pi a it 31 13 SDare Paris season ae eat o intel a lt it 0 eat a d 32 TA AN ANE AIM Vises zoana eo also a lea t aa iat 33 Maintenance amp Repair Within USA 33 Maintenance amp Repair Within Canada 33 MIDWEST Electric Handpiece System 1 Introduction The Midwest E Electric Handpiece System is a dental handpiece system with various attachments intended for cutting shaping filing drilling cleaning and polishing procedures in both general and endodontic dentistry System Contents The Midwest E Electric Handpiece S
20. outlet on motor coupling Air requirements Air filter Water quality ph value Water filtration provided by customer 100 40 000 max 3 0 max 5 7 max 22 Duty cycle 0 5 on 9 off max 250 10 1 to 2 5 bar 14 5 to 36 2 psi 0 8 to 2 0 bar 11 6 to 29 psi 0 69 1 521 110 x 6x 1 5 mm 4 33 x 2 99 x 6 89 inch clockwise counter clockwise lt 40 ISO 3964 Part of class system 100 240 50 60 120 Duty cycle 0 5 on 9 off 0 57 kg 1 26 Ibs 73x41 x175 mm 2 87 x 1 61 x 6 89 inch II P2 IP 40 3 5 to 4 0 bar 50 8 to 58 psi 1 0 to 2 5 bar 14 5 to 36 2 psi 0 8 to 2 0 bar 11 6 to 29 psi 10 Dry free from oil clean uncontaminated 50 Tap water 7 2 7 8 80 Rpm min Nem A Phase V AC minutes mA NI min kg Ibs dBa V AC Hz VA min NI min according ISO 7494 2 um um Electric Handpiece System 12 Specifications Recommended Input Settings System pressure 4 0 bar 58 psi Spray air 1 0 bar 14 5 psi Spray water 0 8 bar 11 6 psi Operating Conditions of Control Unit and Power Supply Location Permitted in interior rooms Ambient temperature 10 to 35 C 50 to 95 F Relative humidity 30 to 75 Max altitude 2000 m Storage and Transport Conditions A PRECAUTION Starting up the medical device after storage in very cold conditions can cause an operational failure of the medical device Very cold devices must be bro
21. r to the Midwest E Motor and Handpiece Attachment Operator s Manual for specific details Clean the system which includes the Control Unit Hoses and Motor Housing with a clean damp cloth using 60 70 isopropyl alcohol and water solution NOTES Do not exert any pressure on the LCD screen Do not use products containing acetone chlorine or bleach as disinfecting agents on the Control Unit Never immerse the Control Unit in solvent The device is not suitable for cleaning in an ultrasonic bath VVV WV CAUTION Disinfectants containing phenol 3 may discolor the plastic housings and are not recommended for use on the Midwest E System Maintenance WARNING A Repair and maintenance work on the Midwest E Electric Handpiece System must only be performed by authorized DENTSPLY personnel DO NOT OPEN THE CONTROL BOX There are no serviceable parts inside the control box Electric Handpiece System 10 Troubleshooting The medical device heats up and gets excessively hot when running without a load gt Check and ensure the amount of cooling air coming from motor meets specification as described in the installation section on Page 12 The handpiece light is off gt Check if the Handpiece Light control has been turned off Refer to Page 15 in Setup Mode or Page 20 in Preparation Mode for turning on the handpiece light Error Code ERR 10 Phase interrupted gt Check the motor hose connection to the cont
22. re to be observed Endodontic Mode Attachments for root canal treatments should only be used in Endodontic Mode to prevent personal injury Always comply with the endodontic handpiece and file manufacturer s instructions regarding maximum speeds torques forward and reverse directions and use of all instrumentation drills burs etc used in endodontic applications Risk of Fire Operation Oxygen Enriched Environment Do not operate this product in the presence of flammable anesthetics such as ether in combination with air oxygen enriched environments or nitrous oxide explosion can result Reference IEC 60601 1 NOTE Nitrous Oxide alone is not a flammable anesthetic Electric Handpiece System 2 Important Information jh e Handpiece Attachments Follow and adhere all instructions described in the Handpiece Attachment Directions for Use Ensure Handpiece Attachments are inserted completely such that the attachment and motor are flush with each other Follow the separate User Manual for attaching and using the dental attachments Improper handling can result in personal injury A e Inspect Power Cord and Control Unit Case Inspect the power cord and the control unit case before use for any damages to the cord ground wire or Casing Precautions e Avoid Adhesive Labels on the Instrument Tubing i Attaching adhesive labels or tape to the intrument tubing may cause the tubing to break i e Cleaning the System o Do not
23. reparation for Use Connect the Dental Motor 1 Connect the motor hose to the control unit Locate the motor hose pin connector on the back panel of the unit Snap the hose male connector to the female end on the unit aligning the pins together as shown in the figure below Figure 6 Connect Motor Hose Tubing to the Control Unit NOTE This motor hose can be disconnected from the control unit by pulling the connector away from the back of the unit for service and replacement Connect the Midwest E motor to the motor hose tube Lightly coat the O rings on the motor with a lubricant spray Align the pins on the motor with the holes on the motor hose until the two matches twist the two together to lock as shown in Figure 7 below NOTE To Measure the air supply coming out of the end of the motor coupler as shown in Figure 8 below The value must be at least 10 l min oF dez Gg pN pr Figure 7 Connect the Motor to the Supply Tubing Figure 8 Air supply measuremeni MIDWESTE Electric Handpiece System 4 Installation and Preparation for Use System Icons Icons Keys Used to Program and Operate the Device PREP Preparation Mode Main Menu PREP ENDO Endodontic Mode Main Menu SET SETUP Set Up Mode Main Menu UP HANDPIECE LIGHT Instrument light on off Main menu and Set up menu Submenu illumination setting Submenu illumination setting delay time FIBER OPTIC Submenu in the Set
24. ress PREP to access the Preparation Mode presets 3 Press P1 P2 P3 or P4 icon to view and edit the settings 6 when activated the background becomes highlighted Electric Handpiece System 7 Preparation Mode To Change Gear Ratio 5 4 Activate the gear ratio settings by pressing the GEAR RATIO icon Select the appropriate increase or reduction ratio using the or a Icons to match the gear ratio of the handpiece attachment currently being used 5 Confirm the gear ratio by pressing the GEAR RATIO icon again To Change Speed 2 6 Activate the speed by pressing the SPEED icon 2 00000 when activated the background becomes highlighted 7 Change the speed using the or icons until the speed desired is displayed 8 Confirm by pressing the SPEED icon again the color of the icon will RPM PS return back to its original color 9 Select the fiber optic light option by pressing on the LIGHT icon If the To Change Light Preference 3 Pee Symbol has a slash through it the light is off if there is no slash the light is on NOTE The intensity of the light can also be changed separately in SETUP Mode See directions for SETUP Mode on Page 15 for details To Change Direction of Rotation O 10 Select the direction of motor rotation by pressing the DIRECTION OF ROTATION icon 11 The arrow on the icon illustrates the direction of rotation i e clockwise or counter O clockwise when the
25. rol unit and ensure it is securely connected Reset the system by powering the unit OFF ON by disconnecting re connecting the power supply on the back of the unit Error Code ERR 10 Motor not connected correctly gt Check and ensure the motor assembly is connected correctly to the motor hose per the installation instructions on Page 12 Reset the system by powering the unit OFF ON by disconnecting re connecting the power supply on the back of the unit Error Code ERR 82 Position sensor not connected gt Check and ensure the motor hose is connected correctly to the control unit per the installation instructions on Page 12 Reset the system by powering the unit OFF ON by disconnecting re connecting the power supply on the back of the unit Error Code ERR 84 Phase short circuit gt Check for any damage on the tubing or motor assembly Contact DENTSPLY Service Center on Page 32 if any damage found Reset the system by powering the unit OFF ON by disconnecting re connecting the power supply on the back of the unit Incorrect motor speed and or attachments during use gt Check to ensure the handpiece attachment connected matches the Gear Ratio specified on the User Interface gt Check to ensure the pressure into the Control Unit complies with the installation instructions and Technical Specifications table on Pages 29 and 30 NOTE Resetting the system by powering it OFF ON will not erase any settings set b
26. rotary instrument is facing away from the user Storing Settings in Memory 12 Pressing the P1 button and holding it in until the signal sounds stores all the settings set in menu option P1 for later use NOTE Changes to the speed torque and direction of rotation can be made while the device is in use However settings will not be overwritten in each program memory unless saved by the user 13 Follow the same procedure for setting P2 P3 and P4 memories if desired Table 2 below describes the maximum speed limits available for respective gear ratio in PREP or ENDO Mode Speed selection at ratio 5 1 Speed selection at ratio 1 1 Speed Selection at ratio 1 5 20 to 100 rpm in steps of 5 100 to 1 000 rpm in steps of 50 500 to 1 000 rpm in steps of 50 100 to 1 000 rpm in steps of 50 1 000 to 2 000 rpm in steps of 100 1 000 to 2 000 rpm in steps of 100 1 000 to 2 000 rpm in steps of 100 2 000 to 10 000 rpm in steps of 500 2 000 to 10 000 rpm in steps of 500 2 000 to 8 000 rpm in steps of 500 10 000 to 40 000 rpm in steps of 1 000 10 000 to 50 000 rpm in steps of 1 000 50 000 to 100 000 rpm in steps of 5 000 100 000 to 200 000 rpm in steps of 10 000 Table 2 Speed Limits per Gear Ratio Settings Electric Handpiece System 8 Endodontic Mode Endodontic Mode Operations Endodontic Mode ENDO allows the user to regulate change the motor speed torque operational direction and auto reversin
27. sed power and torque poorly maintained misused worn or damaged handpieces can potentially generate friction induced heat capable of causing serious burns to patients and staff The following guidelines should be followed to ensure safe operation of electric handpieces o Carefully follow these maintenance instructions o Use only Midwest maintenance products o Always examine the handpiece for damage before each use Immediately stop using the handpiece if it begins generating heat excessive noise or vibration o NEVER apply pressure to the chuck release button while the handpiece is rotating or use the handpiece as a cheek or tongue retractor Only Use the AC Power Adaptor and Control Unit Supplied for this Equipment Using other AC Power Adapiors or Control Units may cause personal injury or damage to the equipment Proper Disposal is Required To dispose of this device adhere to local state federal and or other governing regulations Electric Handpiece System 2 Important Information A Radio Frequency Interference The Midwest E Electric Handpiece System meets the electromagnetic compatibility EMC requirements as specified in the International Electrotechnical Commissions IEC 60601 1 2 2007 standard for electromagnetic compatibility There may be potential difficulties if the device is not kept separate from other equipment such as hand held transmitters cellular phones and electrosurgical equipment that may g
28. structions for Use at the discretion of DENTSPLY and has not been subject to apparent misuse abuse or accident All questionable defective or loose parts must be returned with proof of purchase transportation prepaid Not following the provided instructions for Installation Operation and Maintenance will void the warranty There are no warranties express or implied which extend beyond the description of the face hereof DENTSPLY neither assumes nor authorizes any person to assume for it any other liability in connection with the sale or use of its products Damages are limited strictly to repair or replacement of parts DENTSPLY expressly disclaims liability for incidental and consequential damages resulting from the use of the products Claims covered by this warranty will be honored when presented through your DENTSPLY Professional distributor within 30 days from discovery of defect within the applicable warranty period Maintenance amp Repair Within USA Midwest Air Repair 901 West Oakton Street Des Plaines IL 60018 1843 800 800 7202 Maintenance amp Repair Within Canada Contact your dealer of choice to arrange maintenance amp repair MIDWEST Electric Handpiece System
29. u GEAR SETTINGS _ Additional memory of reduction Set up menu ratio for future handpieces with different ratios than currently available Electric Handpiece System 5 Set Up Mode Set Up Mode Operations To enter in the Set Up Mode menu press on the SETUP icon on the left of the home screen You will then enter into the Set Up Mode Menu as shown in Figure 10 below Setup Mode SETUP Mode Icon E jerome NONE NORTE a R RS 0 AA S ZI 6 ie qo a CA 1284 2 Lo fesas QE BoA Figure 11 Setup Mode Menu Set Up Mode SETUP allows the user to adjust the following Parameters 0 100 compression Speaker LCD Illumination 9 zero setting Calibration A Fiber Optic Delay Handpiece Light zero setting o A hse ewe i 5 sec 2 Sec Auto Reverse Forward option 10 min Additional Gear Settings Mode Service Sub Menu Page 15 Electric Handpiece System 5 Set Up Mode Calibration Calibration of the Midwest E Electric Handpiece System should be performed each time the device has been installed or moved to different location where the air pressure from the foot pedal may vary To Calibrate the Foot Control 1 Press the SETUP icon to enter Set Up Menu SET 2 Pressthe PSI BAR icon to start the calibration process 3 The PSI BAR icon will be highlighted to show you are in calibration mode PII BAR Calibratin
30. ught to a temperature of 20 C to 25 C 68 F to 77 F before being started up Ambient temperature 30 to 70 C 22 to 158 F Relative humidity 51095 Air pressure 700 to 1060 hPa Keep dry Type Label Manufactured for DENTSPLY Professional A Division of DENTSPLY International 901 West Oakton Street ED Des Plaines IL 60018 1843 USA a Name MIDWESTE Electric Handpiece System xo pA T REF 875040 Consult EJ Instructions Type B MEC YYMMO000 for Use Applied Part 33 36 V DC max 120 VA og Made in Germany 87504 0914 The explanations of the symbols are described in Chapter 2 Important Information Electric Handpiece System 13 Spare Parts Spare Parts PART PART NUMBER PART DESCRIPTION 875040 CONTROL UNIT 875070 POWER SUPPLY amp CORD 875045 MIDWESTOE MOTOR 875055 MIDWEST E MOTOR O RINGS 875060 MIDWEST E MOTOR HOSE CONNECTION O RING MIDWEST E MOTOR SEAL 875065 875050 DETACHABLE HOSE DETACHABLE HOSE CONTINENTAL DENTAL UNIT 8 50395 BUGGY WHIP 875075 875080 LCD SCREEN EXTENSION KIT INSTALLATION KIT ARI Electric Handpiece System 14 Warranty The Midwest E Electric Handpiece System and Motor is guaranteed to be free of defects in material and workmanship for a period of 36 months from date of purchase Note the handpiece attachments are guaranteed for 24 months provided the unit has been operated and maintained as prescribed in these In
31. use products containing acetone chlorine or bleach as disinfecting agents o Do not immerse the system in solution e Motor Operation Note To prevent overheating the motor should not be operated at maximum speed and torque for more than 30 seconds in any 9 minute interval This duty cycle is typical of its intended use Adverse Reactions None Known Electric Handpiece System 2 Important Information Applied Symbols Appearing in the manual Appearing on the unit Operation mode Duty A potential hazard to 0 5 cycle The operation the operator patient JU min time is 0 5 minutes with Manufacturer a 9 minutes interval Important information for the operator A RE potential hazard that pH one ul Eechens a 4 A MET test mark may lead to damage to for Use the device Disposal information see Important Information Disposal Appearing on the packaging in 2 Stacking restrictions Humidity C 2 Keep dry we Temperature range Quantity Transport upright B Air pressure Exclusion of Liability Eare Did Supply of spare parts service and maintenance may only be carried out by authorized personnel DENTSPLY shall assume no liability for accidental special or consequential damage caused by maintenance or service of the Midwest E unit by third parties or for use of equipment or parts manufactured by third parties including loss of profit any commercial loss economic loss or loss incurred by person
32. y the user All user specified memory settings will still be saved If necessary insert a filter water trap or air dryer to meet air requirements see also Chapter 12 Specifications Electric Handpiece System 11 Information on Electromagnetic Compatibility The medical device is suitable for use in the specified electromagnetic environment The purchaser or user of the medical device should ensure that it is used in an electromagnetic environment as described below Emission Test Radio Frequency Emissions CISPR 11 Group 1 The medical device uses RF energy only for its internal function Therefore the RF emission is very low and not likely to cause any interference in nearby electronic equipment Radio Frequency Emissions CISPR 11 The medical device is for use in all facilities including residential facilities Harmonic emissions IEC 61000 3 2 and facilities that are directly connected to a public power supply that also Voltage fluctuations flicker emissions IEC Complies supplies residential buildings 61000 3 3 Immunity tests IEC 60601 test level Conformance level Electromagnetic environment guidelines Electrostatic discharge ESD 6 kV contact discharge 6 kV contact discharge Floors should be made of wood or concrete or IEC 61000 4 2 8 kV atmospheric 8 kV atmospheric have ceramic tiles When the floor is covered with discharge discharge synthetic material the relative humidity must be at least 30 Fast transient electrica
33. ystem is comprised of the following components Midwest E Electric Handpiece System Midwest E Motor Power Cord Mounting Attachment Directions for Use Electric Handpiece System 2 Important Information Indications for Use The Midwest E Electric Handpiece System is intended for use by dental professionals in the performance of dental restoration prophylaxis and endodontic procedures Attachments are offered to complement the system used for general dentistry work The intended use of the respective attachment is dependent on the gear ratio The System offers handpiece attachments for the removal of decayed matter cavity and crown preparations and removal of fillings and surface finishing of tooth and restoration surfaces In addition the system offers attachments for caries excavation and endodontics Contraindications None known Warnings WARNING This product is intended for use by dental professionals only Before operating the system carefully read and follow these intructions and save them for future reference Observe all cautions and warnings including A A This Medical device is only intended for dental treatment As described in the Indications for Use any other type of use or alteration to the product is prohibited and can lead to personal injury or damage to the product Electric Dental Micromotors generate significantly more power than traditional air turbines and air motors Due to this increa
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