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Related Manuals for Refine A7
Summary of Contents for Refine A7
- Page 1 Model: A7 RF-APL-M001-1.2...
- Page 2 For your safety and the safety of your patients please read this user manual carefully before use and file for future reference. This manual is published by Manufacturer. We do not guarantee its contents and reserves the right to amend at anytime without prior notice, amendments will be published in new editions of this manual.
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Page 3: Table Of Contents
Contents 1. Intended Use .............................1 2. Precautions ............................1 3. Contraindication ..........................2 4. Package Contents ..........................3 5. Component ............................4 6. Installation ............................7 7. Operation ............................8 8. Audio Alarm Volume Control......................11 9. Maintenance ............................11 10. Charging Battery ..........................13 11. Regular Maintenance Checks ......................14 12. -
Page 4: Intended Use
1. Intended Use Intended use: determination of the apical foramen position and measurement of the root canal length. The product is only to be used in dental surgeries by qualified dental personnel. 2. Precautions • All precautions should be read and understood before use. •... - Page 5 CAUTION: • Do not keep using the product when the battery indicator “ ” is flashing. Normal operation or indication may not be performed. Please recharge the battery. • Should the product function abnormally during operation, cease operation immediately. • Do not use the product by connecting or integrating into other medical devices. •...
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Page 6: Contraindication
• Always dry the cavity entrance with a cotton pellet in order to obtain an accurate measurement. • Users are responsible for the operational control, maintenance and continual inspection of this product. • The battery can be replaced, please contact our distributor if a replacement battery is required. 3. -
Page 7: Component
Accessories list Name Quantity Consumable? Can be sterilized? File clip 4 PCS Measuring wire 1 PCS Battery 1 PCS Lip hook 4 PCS File probe 4 PCS AC adapter 1 PCS 5. Component 5.1 Control Unit... - Page 8 Displays the position of the file tip, remaining battery LCD Panel level and alarm sound volume When the Power key is pressed, the power turns on Power key sounding an alarm, then the LCD panel lights up, press the Power key again, the power and the LCD panel turns off. When the Alarm key is pressed, the alarm audio volume Alarm key can be adjusted (rotation of OFF->Low->Medium->High).
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Page 9: Installation
Bar graph Displays the approximate position of the end of the file Batter Displays the remaining battery level. When the Battery indicator flashes, indicator immediately recharge the device with AC adapter Displays the alarm audio volume Alarm indicator (rotation of OFF ->Low ->Medium ->High... - Page 10 2) Connect the file clip: connect the plug of the file clip to either plug of the measuring wire. (Fig.3) 3) Connect the lip hook: connect the lip hook to the other plug of the measuring wire. (Fig.3) Fig.1 Fig.2 Fig.3 4) Make the lip hook touch the bent section of the file clip (Fig.4), the screen will display“OVER”,(as show in Fig.5 c), otherwise, it means the file clip or the measuring wire is damaged, and should be replaced.
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Page 11: Operation
6) Demonstration mode Demonstration mode tracks the movement of the file a. Pull out the measuring wire and adapter. b. Turn on Apex Locator c. Press “ ”button for 2 seconds to enter demonstration mode Demonstration mode will be exited by finishing demonstration or pressing demonstration mode button. 7. - Page 12 make sure the tooth is marked in a practical and most resilient part of the tooth. 7.1.11 The root canal must be cleared of any pulp or necrotic tissue and there must be no inflammation or infected material surrounding the apex. 7.1.12 The following cases are not for use with the apex locator.
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Page 13: Audio Alarm Volume Control
7.2.6 The file probe may also be used instead of the file clip to touch the file when working on posterior to determine the working length of the canal. (Fig.9) 7.2.7 After use, press the Power key for approximately one second to turn off the power (the alarm sounds and the LCD panel turns off). - Page 14 2. Repeat until accessories are visibly clean. Note: a. Clean and sterilize the accessories before each use to prevent any contamination. This includes the first use as well as any subsequent use. b. Accessories that should be cleaned include: measuring wire, file clip, lip hook, file probe. c.
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Page 15: Charging Battery
instructions for use. • Do not touch the product immediately after autoclaving as it will be very hot and must remain in a sterile condition. • Reprocessed products should be stored, protected from dust with minimum exposure to germs in a dry, dark and cool place. -
Page 16: Regular Maintenance Checks
used for extended periods. • Only the NCM 14500 DC 3.6V/850mAh Rechargeable Li-ion Battery Cells which have passed the IEC 62133 certification can be used. 3) If you need to replace battery please contact us or your dealer. How to install the battery: a. -
Page 17: Trouble Shooting
Check with the tester, that the cable and the control unit operate Product operation properly, following the instruction in “6. Check before Treatment and Installation” * See trouble shooting chart if problems are discovered 12. Trouble Shooting When a problem is detected, check the following again before requesting a repair. Malfunction Cause Solution... - Page 18 The lip hook is not firmly in Adjust the lip hook position so that it correctly contact with the membrane contacts the membrane in the oral cavity of the patient’s oral cavity Perforation of the canal or Remove the file , close the perforation and repair the an adjacent surface has caries, then repeat the apex detection procedure, caries...
- Page 19 Bar graph is not The file clip is not clean Replace or clean the file clip stable or is damaged Bar graph operates correctly when the file reaches The root canal is closed the apical constriction. In this case, always check in combination with X-ray photography Bar graph does not The inside of the root...
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Page 20: Specifications
Root canal may be blocked b y rem nant s of me dical Rinse the root canal with NaCl solution. Dry the products access cavity with a cotton pellet/air-blower Bar graph does not (e.g. calcium hydroxide) move The selected file is too small Use the largest file possible for the canal to for a large root canal produce the most accurate result... -
Page 21: Classification Of Equipment
AC Adapter: UES06WZ-XXXYYYSPA 100-240V AC 50Hz/60Hz Battery: NCM 14500 Rechargeable Li-ion Battery DC 3.6V/850 mAh Working Voltage DC 3.6V Working Current DC: 0.13-0.14A Rated Power ≤ 0.5W Measurement Voltage AC 200mV Measurement Current AC AC 100μA Screen 5.1” LCD ( 110 mm x 70 mm ) Display Reflective colour LCD display The beeper will sound when the file is... -
Page 22: Operation Principle
− Type BF applied part • Method of sterilization recommended by the manufacturer: − See “9-2 Sterilization of the file clip, lip hook and file probe” • Degree of protection against ingress of water as detailed in the current edition of IEC 60529: −... -
Page 23: Warranty
Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy for diagnosis or treatment Following the waste of electric and electronic equipment (WEEE) Directive (2002/96/EC) for product and accessory disposal IPX0 Symbol for “Protection from ingress of liquids into device”... -
Page 24: Disposing Product
20. Disposing Product In order to avoid the health risks of operators handling of medical equipment, as well as the risks of environment contamination caused thereof, a surgeon or a dentist is required to confirm the equipment is sterile. Following the waste of electric and electronic equipment (WEEE) Directive (2002/96/EC) for product and accessory disposal. - Page 25 The product uses RF energy only for its internal function. Therefore, its RF RF emissions CISPR 11/EN55011 Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emission CISPR 11/EN55011 Class B The product is suitable for use in all e s t a b l i s h m e n t s , i n c l u d i n g d o m e s t i c Harmonic emissions EN/IEC 61000-...
- Page 26 Floors should be wood, concrete or ceramic tile. If floors Electrostatic discharge ±6 kV contact ±8 ±6 kV contact ±8 a r e c o v e r e d w i t h s y n t h e t i c (ESD) IEC 61000-4-2 kV air kV air...
- Page 27 UT)for 0.5 cycle 0.5 cycle or hospital environment. If 40% UT(60% dip in Voltage dips, short 40% UT the user of the A7 requires interruptions and (60% dip in UT)for 5 continued operation during for 5 cycles voltage variations on...
- Page 28 Portable and mobile RFcommunications equipment should be used no closer to any part of the product, including cables, than the recommended Conducted RF 3 Vrms 150 kHz 3 Vrms 150 kHz separation distance calculated from the IEC 61000-4-6 to 80 MHz to 80 MHz equation applicable to the frequency of the transmitter.
- Page 29 NOTE 1：At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2：These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
- Page 30 NOTE 2：These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Guilin Refine Medical Instrument Co., Ltd. No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin, Guangxi, 541004, P.R. China Tel: +86-773-7796686 Email:refine@refine-med.com...
- Page 31 After service and warranty instruction 1 Period validity: Five year’s free repair for the main unit, one year's free repair for the handpiece from the date of purchase. Lifetime maintenance. 2 Range of warranty: Within the warranty period of validity, we are responsible for any troubles caused by quality problems or products technique and structure.
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