Apex Locator Operation Instructions Notice Of Protect Intellectual Property US PAT. 5295833 US PAT. APPLN. 12/075,714 US PAT. D601262 DE PAT. 4232487 DE PAT. APPLN. 10 2008 012 677.2 EP DESIGN 0767330 CN DESIGN 200730323057.6 KR DESIGN 0479569 JP PAT. 3113109 JP PAT. 3113095 JP PAT. 4763637 JP DESING 1313285 BR DESIGN 6703093-9 IN DESIGN 212337 RU DESIGN APPLN.
CONTENTS 1. Parts Identification ...................................................................................................................1 2. Before Using the Unit................................................................................................................2 Connecting the Probe Cord .........................................................................................................3 Checking the Function ....................................................................
ii Operation 2011-09-30
Disclaimer ■ The J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, or bodily injury resulting from: 1. repairs made by personnel not authorized by the J. Morita Mfg. Corp. 2. any changes, modifications, or alterations of its products 3. the use of products or equipment made by other manufacturers, except for those procured by the J. Morita Mfg. Corp. 4. maintenance or repairs using parts or components other than those specified by the J. Morita Mfg. Corp.
WARNING • This unit must not be connected to or used in combination with any other apparatus or system. It must not be used as an integral component of any other apparatus or system. J. Morita Mfg. Corp. will not be responsible for accidents, equipment damage, bodily injury or any other trouble which results from ignoring this prohibition. • Accurate canal measurement is not always possible depending on the shape and condition of the tooth as well as a decline in the equipment’s performance.
1. Parts Identification Indication for use Root ZX mini is a dental device, Apex Locator. It can be used to detect the apex of root canal.
2. Before Using the Unit NOTE Root ZX mini is shipped without the batteries installed. size) batteries. Remove the cover and install the 3 LR03 (AAA Installing the Batteries 1. Slide the cover in the direction by the arrow in the illustration and remove it from the RooT ZX mini. 2. Insert the 3 LR03 (AAA size) batteries included in the package. (1) Insert the batteries by first pressing center of the minus end against its spring contact.
Connecting the Probe Cord 1. Insert the probe cord completely into the jack on the left side of the Root ZX mini. NOTE • Handle the Root ZX mini carefully; do not drop, bump or expose the unit to other kinds of impacts or shocks. Rough handling could cause damage. • Make sure the probe cord plug is securely plugged into the jack. A poor connection can prevent measurement. • Do not drop anything on or bang the probe cord plug after it has been inserted into the jack. 2.
WARNING Check the Root ZX mini’s operation before each patient. If the indicators in the display do not all appear normally, the instrument may not be able to make an accurate measurement. In this case, stop using the instrument and have it repaired. Checking the Function with the Tester Check Root ZX mini’s performance with the tester once a week. 1. Press the Power switch to turn the unit on. 2. Insert the tester into the probe cord jack.
3. Operating the Unit Operation Conditions for the main unit Temperature: +10° C (50° F) to +40° C (104° F), Relative Humidity: 30 ~ 80 % (without condesation), Atmospheric Pressure : 800 ~ 1,060 hPa * If the unit has not been used for some time, make sure it works properly before using it again. WARNING Never connect the Root ZX mini to any device not approved by the J. Morita Corp.
Settings 1. Select Memorized Flash Bar Method Press Set Switch. Each press of the Set Switch will change the memory selected in the sequence 01 to 02 to 03 and then back to 01 again. The Flash Bar set for each memory will appear when that memory is selected. The memory selected when the unit is turned off is the one that will be selected when is it turned back on again. 2. Set the Flash Bar Flashes The Flash Bar can be set anywhere from 2 to Apex (0). Use it as an estimate of the canal’s working length.
4. Beeper Volume The volume of the beep can be set for Loud or Soft, or it can be turned off. Method Hold down the Set Switch and turn the Root ZX mini on. This will change the setting of the beep from Loud to Off. Repeat the procedure to change it from Off to Soft. The setting will be memorized and stay the same the next time you turn the unit on. NOTE The volume of the beep that sounds when the unit is turned on cannot be adjusted. WARNING Check the settings displayed after selecting memories.
■ The meter’s 0.5 reading indicates that the tip of the file is in or very near the apical constriction. * The numerals on the meter gauge do not represent millimeters. Flashes ■ If the file tip reaches the apical foramen, a single, sustained beep will sound, and the word "APEX" and the little triangle next to the Flash Bar will start to flash on and off. Flashes Operating the Unit 1. Turn the unit on. 2. Hook the contrary electrode in the corner of the patient's mouth.
Press 3. Clip the file holder to the metal shaft of the file. (1) Press in direction of arrow with the thumb. (2) Clip file. (3) Release thumb. File Holder File or Reamer NOTE Handle Metal part of file holder Cutting part and transition to cutting part Do not clip onto this part! GOOD Always clip the file holder to the upper part of file shaft, near the handle.
4. Press the Set Switch to select Memory 01, 02 or 03. Set Switch 5. Insert the file up to the Flash Bar (this point can also be recognized by the change in the beeping). Position the rubber stopper on the tooth surface as a reference point to determine the root canal’s working length. Use the 0.5 reading on the meter to estimate the canal’s length. Flash Bar 6. Determine the working length. File Holder ■ If the file tip is at the 0.5 meter reading, subtract from 0.5 to 1.
Root Canals not suitable for Electronic Measurement Accurate measurement cannot be obtained with the root canal conditions shown below. There may be cases other than these where an accurate measurement cannot be made. Root Canal with a large apical foramen Root canal that has an exceptionally large apical foramen due to a lesion or incomplete development cannot be accurately measured; the results will show shorter measurement than the actual length.
Crown Crown or metal prosthesis touching gingival tissue Accurate measurement cannot be obtained if the file touches a metal prosthesis that is touching gingival tissue. In this case, widen the opening at the top of the crown so that the file will not touch the metal prosthesis before taking a measurement. Debris Cutting debris on tooth Pulp inside canal Thoroughly remove all cutting debris on the tooth. Thoroughly remove all the pulp inside the canal; otherwise an accurate measurement cannot be made.
Root ZX mini Meter Reading and Radiography Sometimes the Root ZX mini meter reading and the x-ray image will not correspond. This does not mean that the Root ZX mini is not working properly or that the x-ray exposure is a failure. * Occasionally, the actual apical foramen does not correspond exactly. The actual apical foramen may be located up towards the crown. In these cases, the x-ray image will seem to indicate that the file has not reached the apex.
4. After Using the Unit 1. Turn the unit off. * The unit will automatically turn off after 10 minutes of non-use. 2. Disconnect the probe cord and other cords or cables. NOTE BAD BAD Cord Always grip the connectors to connect and disconnect cords. 14 • Do not pull directly on the cords when connecting or disconnecting the probe and file holder. Always grip the connectors to connect and disconnect cords. • Do not wrap the probe cord around the body of the main unit.
5. Replacing Batteries Replace the batteries as soon as the battery power indicator starts flashing. WARNING Never use the unit if the battery power indicator is flashing on and off. The unit may not function properly if the battery power is low. * When battery power falls too much, an alarm will sound and the unit will automatically turn itself off. 1. Slide the cover in the direction by the arrow in the illustration and remove it from the Root ZX mini. 2.
6. Sterilization and Replacement Parts Sterilization a. Autoclavable Components [File Holder, Long File Holder(Option) and Contrary Electrode] Recommended temperature and time: 135°C (275°F), 4 minutes minimum with a sterilization pouch. Minimum drying time after sterilization: 10 minutes. or Recommended temperature and time: 121°C (249.8°F), 35 minutes minimum with a sterilization pouch. Minimum drying time after sterilization: 30 minutes.
Storage Transport and Storage Conditions: Temperature: -10° C (14° F) to 70° C (158° F), Realtive Humidity: 8 ~ 80 % (without condensation), Atmospheric Pressure : 700 ~ 1,060 hPa ■ Do not expose to x-rays or direct sunlight frequently or for long times. ■ If the unit has not been used for a long time, make sure it works properly before using. ■ Always remove the batteries prior to storing or shipping the unit. ■ The J. Morita Mfg. Corp.
Working-Life The working-life of this equipment is 6 years from the date of shipment provided it is regularly and properly inspected and maintained. Disposal of Medical Devices The battery should be recycled. Metal parts of the equipment are disposed as scrap metal. Synthetic materials, electrical components, and printed circuit boards are disposed as electrical scrap. Material must be disposed according to the relevant national legal regulations. Consult specialized disposal companies for this purpose.
8. Troubleshooting If the equipment does not seem to be working properly, the user should first try to inspect and adjust it himself. * If the user is unable to inspect the equipment himself or if the equipment fails to work properly after being adjusted or after parts are replaced, contact your local dealer or the J. Morita Corp. Problem Check Points Response Check battery installation. Install batteries properly. Check battery power. Replace batteries. Check cord connections.
Problem Canal Length Indicator overreacts or is too sensitive. (Measurements are too short, poor accuracy or erratic results.) Canal Length Indicator does not move at all or only when the file tip is close to the apical foramen. Cannot set Memory Bar for file tip at desired point.
9. Technical Description Main unit and accessories Model RCM-7 Classification Safety according to IEC 60601-1, IEC 60601-1-2, UL60601-1, CAN/CSA C22.2 NO.601.1-M90 European Directive 93/42/EEC IIa Canada Medical devices Class II Type of Protection against Electric Shock Battery operated Degree of Protection against Electric Shock Type BF applied part Degree of Protection (IEC 60529 ) IPX O Mode of Operation Continuous Main unit Power Supply DC 4.
Symbols Labels The Root ZX mini conforms with the European Directive, 93 / 42 / EEC which includes the requirements for electromagnetic compatibility. Attention, consult accompanying documents. Serial Number [Example of Serial Number] SN O A 0 0 0 1 Year of Manufacture Month of Manufacture Lot No. U V W X A B C D 0001 : : : : 2006 2007 2008 2009 : Jan. : Feb. : March : April L : Dec. Manufacturer This symbol is affixed to fulfill the requirements of EU Directive 2002/92/ED Article 11.
Operation Instructions Authorized representative in the European Community Package Temperature Limitation Battery This symbol is affixed to fulfill the requirements of EU Directive 2006/66/EC Article 21. Batteries provided with this equipment cannot be disposed of as unsorted municipal waste within the European Union. Follow local regulations for disposal.
10. Appendix- Electromagnetic declaration Guidance and manufacturer’s declaration – electromagnetic emissions The RooT ZX mini is intended for use in the electromagnetic environment specified below. The customer or the user of the RooT ZX mini should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity The RooT ZX mini is intended for use in the electromagnetic environment specified below. The customer or the user of the RooT ZX mini should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity The RooT ZX mini is intended for use in the electromagnetic environment specified below. The customer or the user of the RooT ZX mini should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the RooT ZX mini. The RooT ZX mini is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
PUB.
