Instructions for Use. Electric Motor Tabletop Unit EA-53 TT

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Ethelbert Kelley
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1 Instructions for Use Electric Motor Tabletop Unit EA-53 TT

2 Contents Symbols Introduction Risks due to electromagnetic fields Unpacking Safety notes Display guide Optional mounting of the tabletop unit Optional mounting of the tabletop unit display Tabletop unit connections guide Tabletop unit start-up guide Factory settings Restoration & Prosthetics Factory settings Endodontics Display keys Operation change and save settings Operation forward and reverse Operation Endodontics Operation access the set-up menu Operation exit the set-up menu Reset factory settings Standby mode Set-up menu items Restoration & Prosthetics Set-up menu items Endodontics Error messages Cleaning and maintenance Service Technical data Disposal...32 Warranty

3 Symbols Symbols in the Instructions for Use CAUTION! (to prevent damage occuring) WARNING (risk of injury) General explanations, without risk to persons or property Symbols on the tabletop unit Consult Instructions for Use Catalog number Data matrix code Follow Instructions for Use Serial number V Supply voltage of the tabletop unit Date of manufacture Do not dispose of with domestic waste Not suitable for intracardiac application Type B applied part Medical General medical equipment with respect to electrical shock, fire and mechanical hazards only in accordance with UL :2006, CAN/ CSA-C22.2 No M90:2005, CAN/CSA-C22.2 No :2008, ANSI/ AAMI ES : UX (Control No.) 3

4 Symbols on the packaging XXXX CE marking with identification number of the Notified Body This way up DataMatrix Code for product information including UDI (Unique Device Identification) Data structure in accordance with Health Industry Bar Code Fragile, handle with care Permitted temperature range Keep dry Humidity, Limitation 4 "Der Grüne Punkt" (The Green Dot) trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard Caution! Federal law restricts this device to sale by or on the order of a dentist, physician or any other practitioner licensed by the law of the state in which he or she practices to use or order the use of the device.

5 1. Introduction For your safety and the safety of your patients Prior to initial use please read the Instructions for Use completely; they explain how to use your A-dec W&H product and ensure proper, efficient and safe operation. Observe the safety notes on pages 9 to 11. Indications for Use The A-dec EA-53 electric motor system is comprised of a control unit that drives a direct current (DC) electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. Always follow the manufacturer s recommendations for the tabletop unit. Misuse may damage the tabletop unit, create risks, and pose hazards for patients, users, and others. Qualifications of the user We have based our development and design of the tabletop unit on the dentists, dental hygienists, dental employees (prophylaxis), and dental assistants target group. 5

6 Introduction Device labeling statement U.S. Federal law restricts this device to sale by or on the order of a dentist, physician, or any other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the tabletop unit if it is used in compliance with the following directions: > The tabletop unit must be used in accordance with these Instructions for Use. > The tabletop unit has no components that can be repaired by the user. Assembly, modifications or repairs must only be undertaken by authorized A-dec W&H repair centers. > The electrical installation at the premises must comply with the regulations laid out in IEC ("Installation of electrical equipment in rooms used for medical purposes") or with the regulations applicable in your country. > Unauthorized opening of the equipment invalidates all claims under warranty and any other claims. 6

7 2. Risks due to electromagnetic fields Do not use any high frequency (HF) communication equipment (e.g. mobile telephones) during operation. These devices may affect electrical medical equipment. Implantable systems, such as cardiac pacemakers and ICDs (implantable cardioverter defibrillators) can be affected by electric, magnetic, and electromagnetic fields. This motor system emits electromagnetic fields, which means there are some potential risks. For instance, interference may occur and a malfunction of these devices is possible. A-dec W&H recommends the following: > Ask patients and users if they have an implanted device before using this product. > Explain the circumstances to them. > Weigh up the risks and benefits. > Keep this product away from implanted devices. > Make appropriate emergency provisions and take immediate action on any signs of ill-health. > Make appropriate emergency provisions and take immediate action if patients become ill. Symptoms including a raised heartbeat, irregular pulse, and dizziness may signal problems with a cardiac pacemaker or ICD. The current EMC manufacturer s declaration can be requested directly from the manufacturer. 7

Remove the power adapter and the power cord.

8 3. Unpacking Remove the electric motor and any accessories. Remove the tabletop unit and the tubing. Lift out the complete insert. Remove the tubing, two inner boxes, and protective packaging. Remove the power adapter and the power cord. A-dec W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging for future storage and transport. 8

9 4. Safety notes > Before using the tabletop unit for the first time, store it at room temperature for 24 hours. > Only use the power adapter REF > Only connect the mains cable to grounded receptacles. > Check the tabletop unit for damage and loose parts each time before using. Correct any faults or refer to authorized A-dec W&H repair centers. > Check the settings every time the tabletop unit is restarted. > Do not use the tabletop unit if damage is detected. > Always ensure the correct operating conditions. > Perform a test run prior to each treatment. > Run the rinsing function of the dental unit once per day. > Follow the instructions and safety notes in the instructions for use that came with the EA-53 electric motor. > Operation is only permitted on dental units that correspond to the IEC (EN ) and IEC (EN ). Improper use In addition to unauthorized assembly, installation, modification or repairs to the tabletop unit or improper maintenance, non-compliance with the instructions, or the use of accessories and service parts that are not approved by A-dec W&H invalidates all claims under warranty and any other claims. 9

10 Safety notes Danger zones M and G In accordance with IEC / ANSI/AAMI ES , the tabletop unit is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide where such gases may accumulate in concentration in a closed space. The tabletop unit is not suitable for use in oxygen-enriched atmospheres. Zone M, also defined as "medical environment" and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of anaesthetics or medical antiseptics and antibacterial soaps; such atmospheres are typically localized and temporary. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30 angle. Zone G, also known as an "enclosed medical gas system", does not necessarily include areas enclosed around all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities. 10

11 Safety notes Tabletop unit The tabletop unit is classed as "conventional equipment" (closed equipment without protection against the ingress of water). Power adapter Only use the power adapter supplied. Power cord Only use the power cord supplied. Plug the power cord only into a properly grounded receptacle. Disconnect the tabletop unit in dangerous situations from the power supply. > Pull the power plug out of the receptacle. In dangerous situations, the tabletop unit can be disconnected from the power supply using the power cord. 11

12 5. Display guide program display Endo handpiece gear ratio display direction of rotation display Restoration & Prosthetics: motor speed display Endodontics: file speed display speed units display torque display PLUS / MINUS keys torque units display Restoration & Prosthetics: forward/reverse key Endodontics: Auto forward (AF) Auto reverse (AR) Auto stop (AS) program key Endo key torque keys 12

13 6. Optional mounting of the tabletop unit instrument tray holder support bracket 13

14 7. Optional mounting of the tabletop unit display display bracket cable storage (cable length 27 inches) 14

15 8. Tabletop unit connections guide connection for power adapter Standard 4-hole connection for dental unit handpiece tubing (in accordance with ISO 9168 Type 3) 15

9. Tabletop unit start-up guide Ensure that the

to the tabletop unit (in accordance with ISO 9168

r r Plug the power cord into a properly grounded

Connect the power adapter to to the tabletop unit.

16 9. Tabletop unit start-up guide Ensure that the tabletop unit can be disconnected from the power supply at any time. Securely attach the dental unit handpiece tubing to the tabletop unit (in accordance with ISO 9168 Type 3). Pay attention to the positioning! r r Plug the power cord into a properly grounded receptacle ( V AC, Hz). Connect the power adapter to to the tabletop unit. Securely attach the electric motor to the motor tubing. Connect the power cord to the power adapter. 16

17 10. Factory settings Restoration & Prosthetics Program 1 Display shows P1: Maximum motor speed 40,000 rpm Default motor direction: forward Program 2 Display shows P2: Maximum motor speed 20,000 rpm Default motor direction: forward The display shows the speed of the motor. Note: the bur speed is not shown. > Bur speed depends on the gear ratio of the handpiece in use. Program 3 Display shows P3: Maximum motor speed 2,000 rpm Default motor direction: forward 17

18 11. Factory settings Endodontics Program 1 Display shows P1: Endo handpiece gear ratio 2:1 File speed 300 rpm File torque limit 4.0 Ncm The display shows the speed of the file. Note: For the correct file speed and torque limit to apply, the Endo handpiece gear ratio must match the ratio on the display. Program 2 Display shows P2: Endo handpiece gear ratio 2:1 File speed 300 rpm File torque limit 2.5 Ncm Program 3 Display shows P3: Endo handpiece gear ratio 2:1 File speed 300 rpm File torque limit 1.5 Ncm Program 4 Display shows P4: Endo handpiece gear ratio 2:1 File speed 300 rpm File torque limit 1.0 Ncm Program 5 Display shows P5: Endo handpiece gear ratio 2:1 File speed 300 rpm File torque limit 0.5 Ncm 18

19 12. Display keys PLUS key Increase speed MINUS key Reduce speed Hold down the PLUS or MINUS key for fast scrolling. Plus Ncm key Increase torque (inactive in Restoration & Prosthetics operation) Minus Ncm key Reduce torque (inactive in Restoration & Prosthetics operation) Endo key Switch between Restoration & Prosthetics operation and Endodontics operation Forward/Reverse key Restoration & Prosthetics: forward/reverse Endodontics: Auto forward (AF), Auto reverse (AR), Auto stop (AS) 19

13. Operation change and save settings Restoration & Prosthetics operation and Endodontics operation feature a number of adjustable programs. Press the program key (P) to change the program number.

20 13. Operation change and save settings Restoration & Prosthetics operation and Endodontics operation feature a number of adjustable programs. Press the program key (P) to change the program number. Increase speed Reduce speed Increase torque (inactive in Restoration & Prosthetics operation) Reduce torque (inactive in Restoration & Prosthetics operation) Press and hold the program key (P) for approximately 2 seconds to save current settings. The current settings flash and an acoustic signal confirms that all the settings have been saved. 20

21 14. Operation forward and reverse In Restoration & Prosthetics operation the forward/reverse key changes the motor direction. Factory default = Forward operation Press the forward/reverse key to change motor direction. "!" and appear on the display and an acoustic signal is emitted. "!" and flash continuously in reverse operation. An acoustic signal is emitted three times in succession before the motor is started in reverse operation. Press and hold the program key (P) for approximately 2 seconds to save current settings. If the program settings are not saved in reverse operation, the tabletop unit will switch back to forward operation automatically when you change programs. 21

22 15. Operation Endodontics Press the Endo key to switch between Restoration & Prosthetics operation and Endodontics operation. Endo key flashes. Press the program key (P) to change the endo program number. Press the forward/reverse key to select torque limit action: AF / AR / AS When the preset torque limit is reached, the file will: Auto forward (AF): reverse for three rotations, then return to forward operation. Auto reverse (AR): reverse until foot control is released. Auto stop (AS): stop (file does not reverse). 22

23 16. Operation access the set-up menu Separate set-up menus are available in Restoration & Prosthetics operation and Endodontics operation. They allow changing of settings not accessible during normal operation. Press the PLUS and MINUS keys simultaneously for approximately 3 seconds to enter the set-up menu. "Setup" appears on the display. Press program key (P) to scroll through menu items. Press the PLUS or MINUS key to change the setting in the respective set-up menu item. r Press and hold the program key (P) for approximately 2 seconds to save current settings. The current settings flash and an acoustic signal confirms that all the settings have been saved. 23

24 17. Operation exit the set-up menu Press the PLUS and MINUS keys simultaneously for approximately 3 seconds to exit the set-up menu. The most recent program appears on the display. 18. Reset factory settings Press the program (P), Endo and Ncm- keys simultaneously for approximately 3 seconds to return the current program to factory defaults (see page 17, 18). 19. Standby mode 24 The unit automatically switches to standby operation after 1 minute of inactivity. > To exit standby operation and return to most recent program, press any key or activate foot control.

25 20. Set-up menu items Restoration & Prosthetics "Pedal" "Sound" "LED" > STEP: motor speed varies by foot control postion from 2,000 rpm to program speed > ON / OFF: motor speed does not vary with foot control position; motor runs at program speed when foot control is activated > ON: system sounds are active > OFF: system sounds are inactive > After foot control is released, motor light remains on for this many seconds (settable from 0 60 seconds) Factory default: 5 seconds "P1 P5" > Set the number of programs to be available in Restoration & Prosthetics operation. Factory default: 3 programs "Speed" > rpm: speed displayed in rotations per minute (rpm) > %: speed displayed as a percentage of 40,000 rpm Speed rpm % 40, , , , , ,

26 21. Set-up menu items Endodontics Select Endo handpiece or handpiece gear ratio from the following list: > 1:1 > EB-79 (2:1) > 2:1 > 3:1 > EB-77 (4:1) > 4:1 Factory default: EB-79 (2:1) "P1 P9" > Set the number of programs to be available in Endodontic operation. Factory default: 5 programs 26

27 22. Error messages Display Description of error Solutions Error 1 Overheating / overloading of electronics > Disconnect power cable from the tabletop unit. Wait 5 minutes and allow the system to cool. Reconnect power cable and restart the function. Error 2 Foot control active during power connection. > Do not activate the foot control during power connection. Error 4 Error 5 Error 6 Reboot Display keys pressed during power connection. Foot control active for more than 15 minutes. Error with "Electric motor / Endo contra-angle handpiece" General system failure may be solved with a restart of the system. > Do not press the display keys during power connection. > Check foot control. > Do not activate the foot control anymore (release completely). > Check that the electric motor / Endo contra-angle handpiece is correctly attached. > Replace the electric motor / Endo contra-angle handpiece. > Disconnect power cable from the tabletop unit, then reconnect. Error e.g., > Contact an authorized A-dec W&H repair center immediately. If the error messages described cannot be resolved, contact an authorized A-dec W&H repair center. 27

28 23. Cleaning and maintenance Follow your local and national standards and guidelines for cleaning and disinfection. > Always disconnect the power cable from the tabletop unit. > Wear protective clothing and personal protective equipment (PPE). > Clean and disinfect the tabletop unit immediately after each patient. Tabletop unit > The tabletop unit is not approved for mechanical cleaning (thermal washer disinfector) and sterilization. > Do not immerse the tabletop unit in water or clean it under running water. Pre-cleaning > If heavily soiled, clean first with disinfectant cloths. Do not use disinfectants that contain chlorine or protein fixatives. > Use only disinfectants that are certified by officially recognized institutes and do not contain chlorine or protein fixatives. > Follow the disinfectant manufacturer s specifications for proper use. Manual cleaning and disinfection The display of the tabletop unit is sealed and can be wiped. A-dec W&H recommends wiping down with disinfectant. 28

29 Cleaning and maintenance Before resuming operation > Ensure that the tabletop unit is completely dry. Moisture in the plug can lead to a malfunction. (Risk of short circuit) Cable, tubing Do not twist, kink or squeeze the cables! Do not coil them too tightly! The supply tubing is not approved for mechanical cleaning (thermal washer disinfector) and sterilization. 29

30 24. Service Regular servicing of the tabletop unit and accessories Regular servicing is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The inspection must be undertaken by a qualified organization and must include the following procedures: > Visual inspection for external damage. > Check for any changes which could jeopardize safety. > Measurement of device leakage current. > Measurement of patient leakage current. > Check of whether the correct power adapter is being used. If any issues are found during regular servicing or damage is suspected, stop using the unit immediately. Send the unit to your authorized A-dec W&H repair center for service. Repair If a defect occurs, always return all the equipment, as it is also necessary to inspect all of the control electronics! 30 Returns > Refer all questions to authorized A-dec W&H repair centers. > Always return equipment in the original or replacement packaging! For replacement packaging, contact your authorized A-dec W&H repair center. > Do not twist or kink the cables! Do not coil them too tightly! (Risk of damage)

31 25. Technical data Model Power supply: Mains voltage: Dimensions (WxDxH): ISO 9168 supply connection Drive air pressure: Water coolant pressure: Air coolant pressure: EA-53 TT VDC VAC 6.1" x 8.3" x 3.6" (156 mm x 211 mm x 92 mm) psi ( bar) 7 43 psi (0.5 3 bar) 7 43 psi (0.5 3 bar) Ambient conditions Temperature during storage and transport: -40 F to +158 F (-40 C to +70 C) Humidity during storage and transport: 8% to 80% (relative), non-condensing Temperature in operation: +50 F to +95 F (+10 C to 35 C) Humidity in operation: 15% to 80% (relative), non-condensing Permitted ambient pressure: kpa Pollution level: 2 Overvoltage category: II Altitude: Up to 9,843 feet (3,000 m) above sea level Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Equipment according to IEC / ANSI/AAMI ES Type B applied part (not suitable for intracardiac application) 31

32 26. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Tabletop unit > Electrical devices > Packaging 32

33 Warranty A-dec warrants all products in this document against defects in material or workmanship for two years from time of delivery. A-dec s sole obligation under the warranty is to provide parts for the repair, or at its option, to provide the replacement product (excluding labor). The buyer shall have no other remedy. All special, incidental, and coincidental damages are excluded. Written notice of breach of warranty must be given to A-dec within the warranty period. The warranty does not cover damage resulting from improper installation or maintenance, accident or misuse. The warranty does not cover damage resulting from the use of cleaning, disinfecting or sterilization chemicals and processes. Failure to follow instructions provided in the A-dec W&H Instructions for Use (operation and maintenance instructions) may void the warranty. No other warranties as to merchantability or otherwise are made. 2 -year warranty 36

34 Distribution A-dec Inc Crestview Drive Newberg, OR USA Tel: Within USA/Canada Tel: Outside USA/Canada Fax: Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria t , f office@wh.com wh.com Form-Nr CEN Rev. 000 / Subject to alterations

Instructions for use. 400 series. Highspeed Air Handpieces. valid since serial no

Instructions for use. 400 series. Highspeed Air Handpieces. valid since serial no Instructions for use 400 series Highspeed Air Handpieces valid since serial no. 01001 Contents A-dec W&H symbols... 3 4 1. Introduction... 5 7 2. Safety notes... 8 11 3. Product description...12 13 4.