Instructions for Use. A-dec EA-30. Electric Motor System

Transcription

1 Instructions for Use A-dec EA-30 Electric Motor System

2 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 information 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 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

3 CONTENTS 1 Introduction... 1 Product Descriptions...1 A-dec EA-30 Electric Motor Features...1 A-dec Handpiece Tubing Features...2 Safety Notes Before You Begin...2 Caution Notes for the Electric Motor System...3 Asepsis and Maintenance Before First Use Basic Operation... 4 Operation...4 Install and Remove the Motor on the Handpiece Tubing...4 Install and Remove Attachments and Handpieces...6 Test Run Maintenance and Asepsis... 7 Notes for Cleaning...7 Cleaning...8 Clean and Disinfect the Motor...8 Manual Cleaning - External...9 Sterilize the Motor...9 Maintenance...10 Replace the O-Rings on the Motor...10 Change and Fit the Bushings...11 Accessories...11 Service...12 Regular Checkup of the Motor and Handpiece Tubing...12 Minimum Steps for Motor...12 Minimum Steps for Handpiece Tubing...12 Function Test...12 Appendix A: Warranty and Specifications...13 Warranty...13 Specifications...14 Technical Data - Motor...14 Disposal of the Motor...14 Technical Data - Handpiece Tubing Rev D ii

4 A-dec EA-30 Electric Motor System Instructions for Use iii Rev D

5 INTRODUCTION 1 Product Descriptions Following are illustrations of the A-dec Electric Motor and Handpiece Tubing products. A-dec EA-30 Electric Motor Features The A-dec EA-30 Electric Motor features include: Electrical drive for dental transmission instruments for the supply of cooling air, spray air, and cooling liquid with ISO coupling as per ISO Flexible connection and supply element between the dental motor, the unit, and the control unit. Figure 1. A-dec EA-30 Electric Motor Motor Sheath O-Rings Connection ISO Rev D 1

6 A-dec EA-30 Electric Motor System Instructions for Use A-dec Handpiece Tubing Features A-dec handpiece tubing features include: Tubing nut Threaded bushings Figure 2. A-dec Supply Handpiece Tubing Tubing Nut Threaded Bushings 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. Safety Notes Before You Begin Before you use the 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 Rev D

7 Introduction 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 Notes for the Electric Motor System Keep these notes in mind when using the A-dec EA-30 Electric Motor System: The operation of this motor is permitted only on dental units which correspond to the standards IEC (EN ) and IEC (EN ) or as labeled. The dental unit control shall comply with IEC 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. The dental motor should be maintained according to the manufacturer s recommendations and in line with infection control procedures for the safety and wellbeing of patients. Improper use, such as missing hygienic maintenance, or noncompliance with our instructions or the use of accessories and spare parts which are not approved by A-dec, invalidates all claims under warranty and any other claims. Asepsis and Maintenance Before First Use The motor is in a clean condition and sealed in PE-film when it is delivered. Be sure to sterilize the motor before it is used for the first time. See Sterilize the Motor on page Rev D 3

8 BASIC OPERATION 2 Operation Before you can use the handpiece you must assemble the motor on the handpiece tubing. Install and Remove the Motor on the Handpiece Tubing 1. Align the connection tubes of the motor with the connection openings of the handpiece tubing. 2. Screw the tubing nut onto the motor. Figure 3. Install the Motor Step 1 Step Rev D

9 Basic Operation Figure 4. Verify Secure Fastening and Disassembly Step 3 Step 4 CAUTION Do not compress the handpiece tubing too firmly. 3. Check that the motor is fastened securely by looking at the connection. The motor and tubing must be securely coupled. 4. To disassemble the motor, unscrew it from the tubing Rev D 5

10 A-dec EA-30 Electric Motor System Instructions for Use Install and Remove Attachments and Handpieces Follow the instructions for use of the respective attachment or handpiece manufacturer. CAUTION Do not attach or remove attachments or handpieces while the motor is running! 1. Push the attachment or handpiece onto the motor. 2. Check for a secure hold on the motor. 3. Remove the attachment or handpiece from the motor by pulling it away from the motor without twisting. CAUTION When using lighted attachments, you will damage the motor and handpiece if you turn them while removing. Figure 5. Install and Remove Attachments and Handpieces Step 1 Step 2 Step 3 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 ) or the A-dec 500 Delivery Systems Instructions For Use (p/n ) for information on touchpad handpiece settings Rev D

11 MAINTENANCE AND ASEPSIS 3 This section describes how to maintain the A-dec EA-30 Electric Motor System. It provides information on disinfecting and sterilizing, and replacing the O-rings. NOTE Follow your country-specific directives, standards and guidelines for cleaning and disinfection. Notes for Cleaning When cleaning the A-dec EA-30 Electric Motor and Handpiece Tubing: Wear protective clothing. Remove the handpiece from the motor. Prevent liquids from penetrating the motor and tubing. Carefully wipe the exterior of the motor with a soft cloth. Use only commercially available surface disinfectants or ethyl alcohol. Dry the motor completely. Clean and disinfect the motor and the tubing immediately after every treatment to: Flush out any liquid, such as blood, saliva etc., which may have seeped in. Prevent settling on the internal parts. Sterilize the motor following manual cleaning and disinfection Rev D 7

12 A-dec EA-30 Electric Motor System Instructions for Use Cleaning It s important to keep your electric motor clean to ensure proper operation and its longevity. Figure 6. Pre-cleaning Keep these notes in mind when you prepare to clean: If heavily soiled, clean first with disinfectant cloths. Only use disinfectants that have no protein fixing effects. 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, such as missing maintenance and asepsis, non-compliance with our instructions, and the use of accessories and service parts which are not approved by A-dec, invalidates all claims under warranty and any other claims. Clean and Disinfect the Motor 1. Wear protective gloves. 2. Purge the water lines with air. 3. Remove the motor from the tubing by unscrewing the nut and pulling the motor off the handpiece tubing Rev D

13 Maintenance and Asepsis Manual Cleaning - External 1. Rinse under water (<38 C/<100 F) and clean with a brush (A-dec recommends demineralized water). 2. Remove any liquid residues (absorbent cloth, blow dry with compressed air). Figure 7. Manual Cleaning Step 1 Step 2 Sterilize the Motor 1. Place the motor in a sterile pouch (FDA market cleared), equivalent to sterile goods packaging DIN 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). 3. Be sure the motor is dry before removing from the sterilizer Rev D 9

14 A-dec EA-30 Electric Motor System Instructions for Use Maintenance Replace the O-Rings on the Motor A-dec recommends that you replace all of the O-rings on the motor at the same time. 1. Squeeze an O-ring firmly between your 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. Figure 8. Change the O-Rings on the Motor Tubing Terminal Step 1 Step 2 Step Rev D

15 Maintenance and Asepsis Change and Fit the Bushings 1. Unscrew the threaded bushing with a screwdriver. 2. Remove the bushing. 3. Screw in the new bushing with a screwdriver. Figure 9. Change and Fit the Bushings Step 1 Step 2 Step 3 Accessories When you choose accessories for your A-dec equipment: Use original A-dec accessories and spare parts only. Contact an A-dec supplier to request a package of 10 O-rings Rev D 11

16 A-dec EA-30 Electric Motor System Instructions for Use Service Regular Checkup of the Motor and Handpiece Tubing Regular testing of function and safety is necessary and must be completed at least once every three years, unless shorter intervals are prescribed by law. Checking must be performed by a qualified individual or organization and must, at a minimum, include the following steps. Minimum Steps for Motor Complete an external visual inspection and a check on modifications relevant to safety. Check measurement of leakage current. Complete a visual inspection of internal components and electronic boards on suspicion of a safety hazard, such as mechanical damage on the housing or signs of overheated or burned (electronic) components. Check whether the power supply unit is being used as prescribed. Minimum Steps for Handpiece Tubing Complete an external visual inspection and a check on modifications relevant to safety, such as cracks or damages. If you discover cracks or damages, you must replace the handpiece tubing. We recommend that these checks are performed by technical personnel authorized by A-dec or by the unit manufacturer only. Function Test Verify proper function as outlined in Operation on page Rev D

17 APPENDIX A: WARRANTY AND SPECIFICATIONS A Warranty A-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 Rev D 13

18 A-dec EA-30 Electric Motor System Instructions for Use Specifications Technical Data - Motor Category Value Model Number EA-30 Coupling handpiece tubing VE-6 Connection motor/attachment according to standard ISO 3964 Operation mode, optional Forward/reverse rotation Factory preset speed range with control CM-1.1 (rpm) 2,000-36,000 Factory preset speed range with control CM-2.1 (rpm) 2,000-36,000 Adjustment cooling air (l/min) 6-8 Air coolant pressure (kpa) (7-43 psi) (The air coolant pressure has to be higher than the water coolant pressure) Water coolant volume at 50 kpa (ml/min) (Water coolant pressure [kpa]) > (7-43 psi) Operating mode S6 (2 min / 3 min) Ambient temperature max F 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 Handpiece tubing VE-6 REF , , , Connection dental motor EA-30 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 Rev D

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20 A-dec Headquarters 2601 Crestview Drive Newberg, OR USA Tel: Within USA/Canada Tel: Outside USA/Canada Fax: International Distribution Centers A-dec United Kingdom Authorized EU Representative Austin House, 11 Liberty Way Nuneaton, Warwickshire CV11 6RZ England Tel: 0800 ADECUK (233285) Within UK Tel: +44 (0) Outside UK A-dec Australia Unit Ricketty Street Mascot, NSW 2020 Australia Tel: Within Australia Tel: +61 (0) Outside Australia ÍvÈ.Ç!^È.00XÎ Rev D Copyright 2012 A-dec Inc. All rights reserved.