a‑dec ea-52led electric motor instructions for use
TRANSCRIPT
A-dec EA-52LED
InstructIons for use
Electric Motor System
Copyright
© 2012 A-dec Inc. All rights reserved.
A-dec Inc. makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. A-dec Inc. shall not be held liable for any errors contained herein or any consequential or other damages concerning the furnishing, performance or use of this material. The informa-tion in this document is subject to change without notice. If you find any problems in the documentation, please report them to us in writing. A-dec Inc. does not warrant that this document is error-free.
No part of this document may be copied, reproduced, altered, or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without prior written permission from A-dec Inc.
Trademarks and Additional Intellectual Property Rights
A-dec, the A-dec logo, A-dec 500, A-dec 300, Cascade, Cascade Master Series, Century Plus, Continental, Decade, ICX, ICV, Performer, Preference, Preference Collection, Preference ICC, and Radius are registered in the United States and other countries. A-dec 200, Preference Slimline, and reliablecreativesolutions are also trademarks of A-dec Inc. None of the trademarks or trade names in this document may be reproduced, copied, or manipulated in any manner without the express, written approval of the trademark owner.
Certain touchpad symbols are proprietary to A-dec Inc. Any use of these symbols, in whole or in part, without the express written consent of A-dec Inc., is strictly prohibited.
Regulatory Information
The Regulatory Information and Specifications document is delivered with A-dec dental device equipment as mandated by agency requirements. If you need this information, please go to the Document Library at www.a-dec.com.
Intended Application and Use
An electric drive motor, which includes the supply of cooling media for dental transmission instruments, is intended for use in preventative dentistry, restorative dentistry (such as cavity preparation), and prosthodontics (such as crown preparation) during diagnostic and therapeutic treatment by licensed health care professionals.
Product Service
For service information, contact your local authorized A-dec dealer. To find your local dealer, go to www.a-dec.com.
C O N T E N T S
1 Introduction.................................................................................. 1EA-52LED Electric Motor System Features ..................................................................................1
2 Basic Operation ............................................................................. 2Operating Instructions.....................................................................................................................2
Safety Notes Before You Begin...................................................................................................2Caution Notes for the Electric Motor System...........................................................................3Install the EA-52LED ...................................................................................................................4
Install the Motor on the Handpiece Tubing ........................................................................4Install the Handpiece on the Motor ......................................................................................4
Test Run .............................................................................................................................................5
3 Maintenance ................................................................................. 6Clean, Disinfect, and Sterilize .........................................................................................................6
Clean and Disinfect the Motor ...................................................................................................6Clean the Optic Outlet .................................................................................................................6Sterilize the Motor........................................................................................................................7
Replace the O-rings ..........................................................................................................................7Replace the O-ring on the Motor Tubing Terminal.................................................................7Replace the O-rings on the Motor..............................................................................................8
Replace the LED................................................................................................................................9Remove the LED from the Motor...............................................................................................9Install the LED in the Motor .......................................................................................................9
Appendix: Warranty and Specifications .................................................10Warranty ..........................................................................................................................................10Specifications...................................................................................................................................11
Technical Data - Motor .........................................................................................................11Disposal of the Motor ...........................................................................................................11Technical Data - Handpiece Tubing ...................................................................................11
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EA-52LED Electric Motor System Instructions for Use
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INTRODUCTIONEA-52LED Electric Motor System FeaturesThe EA-52LED Electric Motor System features:
• Programmable speed and torque settings for ease of use and safety
• Auto-sensing with auto-forward, auto-stop and auto-reverse
• Up to 8 memory presets per handpiece position (A-dec 500 only)
• Separate A and B presets for two different operators (A-dec 500 only)
• Single-button push between endodontics and standard modes for efficiency
Figure 1. EA-52LED Electric Motor System
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BASIC OPERATIONOperating Instructions
Safety Notes Before You Begin
Before you use the A-dec EA-52LED Electric Motor System, please note the following:
• Check the handpiece tubing and the connection tubes of the electric motor for damage before assembling the handpiece motor.
• Always ensure the correct operating conditions.
• Always ensure the correct supply voltage.
• Check the motor for damage and loose parts before and between uses.
• Check that sufficient air and water coolants are supplied.
• Flammable Gases - The electric motor system is not suitable for use in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide, where such gases may accumulate in concentration in a closed space.
• Make sure that the handpiece tubing is not kinked.
• Prevent the handpiece tubing from coming into contact with sharp objects.
• Use only potable water and air from dental units for the supply.
• Never sterilize the handpiece tubing.
• Interference may occur when used on patients with cardiac pacemakers. This system emits electromagnetic fields, which means there are some potential risks. The malfunctioning of implantable devices such as cardiac pacemakers and ICDs (implantable cardioverter defibrillator) is possible:
○ Ask patients and users if they have an implanted device before using this product. Explain the circumstances to them.
○ Weigh the risks and benefits.
○ Keep this product away from implanted devices.
○ 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.
○ Always follow recommendations made by the manufacturer of the electric motor and the rotary instrument. Misuse may damage the motor, create risks, and pose hazards for patients, users, and others.
CAUTION Do not use the motor as a light sensor or look directly into the optic outlet.
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Basic Operation
Caution Notes for the Electric Motor System
Keep these notes in mind when using the A-dec EA-52LED Electric Motor System:
• The operation of this motor is permitted only on dental units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2) or as labeled.
• The dental unit control shall comply with IEC 60601-1 requirements for output power.
• Electrical safety is inherent in equipment grounding and insulation.
• The dental motors are designed for intermittent operation with an operating time of 2 minutes and an idle time of 3 minutes.
• Sterilize the motor in a water steam sterilizer with vacuum for 4 minutes at 134°C +/- 2°C (273°F +/- 4°F). For gravity displacement sterilization, use 6 minutes at 134°C +/- 2°C (273°F +/- 4°F).
• The power supply unit must be a sealed transformer and comply with the following requirements:
○ Compliance with leakage current requirements is assured by installation of the equipment according to the manufacturer’s instructions.
○ Secondary voltage circuits must be non-grounded.
○ The secondary circuits must be protected against short-circuiting and overloading.
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.
The dental motor should be maintained according to the manufacturer’s recommendations and in line with infection control procedures for the safety and well-being of patients.
Improper use, e.g. missing hygienic maintenance, or non-compliance with our instructions of the use of accessories and spare parts which are not approved by A-dec, invalidates all claims under warranty and any other claims.
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EA-52LED Electric Motor System Instruction for Use
Install the EA-52LED
Install the Motor on the Handpiece Tubing
1. Align the motor connection tubes with the connection openings on the handpiece tubing.
2. Press the motor and the tubing together until you hear two clicks.
Figure 2. Align Motor Connection Tubes and Tubing Connection Openings
3. Check that the motor has engaged the tubing securely. The motor and tubing should not separate with a gentle pull.
Install the Handpiece on the Motor
1. Push the handpiece onto the motor. If the handpiece is fiber optic, be sure to correctly align the notch.
2. Check for a secure hold on the motor. The handpiece should not come off with a gentle pull.
NOTE If the motor fails to connect, remove it from the tubing. Push the tubing nut back to the stop, then repeat Steps 1 and 2.
CAUTION To avoid injury, do not connect or remove the handpiece while the motor is running.
NOTE For information on touchpad handpiece settings, see the Instructions for Use that came with your delivery system.
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Basic Operation
Test Run• Start the motor with any type of E–style handpiece (20 mm diameter gear driven)
attached.
• If you observe problems, such as vibrations, unusual noise, heating, smell or leakage, stop the motor immediately and contact your dealer or A-dec.
NOTE Refer to the A-dec 300 Systems Instructions For Use (p/n 86.0092.00) or the A-dec 500 Delivery Systems Instructions For Use (p/n 86.0607.00) for information on touchpad handpiece settings.
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MAINTENANCEClean, Disinfect, and Sterilize
Clean and Disinfect the Motor
1. Wear protective gloves.
2. Disconnect the handpiece and the motor by pulling the two apart.
3. Carefully wipe the exterior of the motor with a soft cloth. Use only commercially available surface disinfectants or ethyl alcohol.
4. Dry the motor completely.
Clean the Optic Outlet
1. Use a soft cloth dampened with water to gently wash the optic outlet.
2. Use an air syringe or soft dry cloth to dry the optic outlet.
NOTE The electric motor should be maintained according to the manufacturer’s recommendations and in line with infection control procedures for the safety and well-being of patients.
Improper use, e.g. missing hygienic maintenance, or non-compliance with our instructions or the use of accessories and service parts which are not approved by A-dec, invalidates all claims under warranty and any other claims.
CAUTION Be careful not to scratch the optic outlet when cleaning it.
CAUTION Be sure to inspect the optic outlet after you clean it to make sure it is not damaged. If the optic outlet is damaged, do not use it and contact an authorized A-dec dealer.
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Maintenance
Sterilize the Motor
1. Purge the water lines with air.
2. Remove the motor from the tubing by pushing the tubing sheath back up to the stop while pulling the motor off the handpiece tubing.
3. Place the motor in sterile pouch (FDA market cleared), equivalent to sterile goods packaging DIN 58953.
4. Sterilize the motor in a water steam sterilizer with vacuum for 4 minutes at 134 °C +/- 2°C (273 ºF +/- 4ºF). For gravity displacement sterilization, use 6 minutes at 134 °C +/- 2°C (273 ºF +/- 4ºF).
5. Be sure the motor is dry before removing from the sterilizer.
Replace the O-rings
Replace the O-ring on the Motor Tubing Terminal
1. Squeeze the O-ring firmly between thumb and forefinger to form a loop.
2. Slide the O-ring up and off the tubing terminal.
3. Slide the new O-ring on carefully.
Figure 3. Change the O-Ring on the Motor Tubing Terminal
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EA-52LED Electric Motor System Instructions for Use
Replace the O-rings on the Motor
A-dec recommends you replace all O-rings on the motor at the same time. To replace the O-rings on the motor:
1. Squeeze an O-ring firmly between thumb and forefinger to form a loop.
2. Slide the O-ring up and off the motor.
3. Slide a new O-ring on carefully and position it in the groove.
4. Repeat steps 1 through 3 for each O-ring.
Figure 4. Replace the O-Rings on the Motor
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Maintenance
Replace the LED
Remove the LED from the Motor
1. Remove the motor sheath by sliding it off in the direction indicated (see Figure 5).
2. Use the pliers to carefully grip the LED between the LED and its holder.
3. Slide the LED out carefully.
Figure 5. Replace the LED
Install the LED in the Motor
1. Hold the new LED firmly with the pliers.
2. Insert the LED into its holder and push into place.
3. Replace the motor sheath.
CAUTION Remove the motor from the handpiece tubing to change the LED.
NOTE If the LED does not illuminate after you turn on the EA-52LED, remove the LED, rotate it 180°, and reinstall it.
TIP Before you remove the LED, mark the side with a felt tip marker. When you reinstall it, position the mark to the inside.
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APPENDIX: WARRANTY AND SPECIF ICATIONSWarrantyA-dec warrants all products against defects in materials or workmanship for one year 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 Instructions For Use (operation and maintenance instructions) may void the warranty.
No other warranties as to merchantability or otherwise are made. For service information, contact your local authorized A-dec dealer. Check with local codes and ADA (Americans with Disabilities Act) requirements for installation of this product.
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 this device.
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Appendix: Warranty and Specifications
SpecificationsTechnical Data - Motor
Disposal of the Motor
When the motor is to be scrapped, it must be disposed as “special electronic garbage” in accordance with local regulations.
Technical Data - Handpiece Tubing
Category Value
Model Number EA-52LED
Coupling handpiece tubing VE-9
Connection motor/attachment according to standard ISO 3964
Operation mode, optional Torque control, auto reverse
Speed range with control CM-1.1 (rpm) 2,000 - 40,000
Speed range with control CM-2.1 (rpm) 300 - 40,000
Adjustment cooling air (l/min) 6 - 8
Drive air pressure 65 psi minimum
Air coolant pressure (kPa) (The air coolant pressure has to be higher than the water coolant pressure)
50 - 300 (7 - 43 psi)
Water coolant volume at 50 kPa (ml/min)
(Water coolant pressure [kPa])
> 60
50 - 300 (7 - 43 psi)
Operating mode S6 (2 min / 3 min)
Ambient temperature max. 50 - 91°F
Category Value
Handpiece tubing VE-9 REF 54.0162.00, 54.0162.03, 54.0276.00, 54.0276.03
Connection dental motor EA-52LED
Spray air at ~250 kPa (36 psi) (l/min) > 8 (> 0,3 CFM)
Spray water at ~200 kPa (29 psi) (ml/min) > 200
Internal handpiece tubings (pressure max.) 413 kPa (60 psi)
Environmental conditions: Temperature Relative humidity between
-40 °F up to +158 °F 15% and 80% (relative)
NOTE Specifications are subject to change without notice. Some requirements may vary from country to country. For more information, contact your authorized A-dec dealer.
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A-dec Headquarters2601 Crestview DriveNewberg, OR 97132 USATel: 1.800.547.1883 Within USA/CanadaTel: 1.503.538.7478 Outside USA/CanadaFax: 1.503.538.0276www.a-dec.com
International Distribution Centers
A-dec United KingdomAuthorized EU RepresentativeAustin House, 11 Liberty Way Nuneaton, Warwickshire CV11 6RZ England Tel: 0800 ADECUK (233285) Within UKTel: +44 (0) 24 7635 0901 Outside UKwww.a-dec.co.uk
86.0021.00 Rev CCopyright 2012 A-dec Inc.
All rights reserved.
A-dec AustraliaUnit 85-9 Ricketty StreetMascot, NSW 2020 AustraliaTel: 1.800.225.010 Within AustraliaTel: +61 (0)2 8332 4000 Outside Australiawww.a-dec.com.au
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