Summary of Contents for Romidan RomiApex A-15
- Page 1 RomiApex™ A-15 APEX LOCATOR User Manual Please scan the QR code to view RomiApex A-15 additional instructions.
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Page 2: Table Of Contents
Table of Contents Introduction 1. Indications for use 2. Warnings 3. Precautions 4. Package Contents 5. Getting Started 5.1 General 5.2 Installing / Replacing the Battery 5.3 Cable connection test 5.4 Device operation 5.5 Audio feedback 5.6 Automatic Shutdown 6. Demo mode 7. -
Page 3: Introduction
Introduction Congratulations on the purchase of your RomiApex™ A-15 Apex Locator. The RomiApex™ A-15 Apex Locator is a battery operated portable device which uses the frequency dependent impedance method and proprietary algorithms to determine the position of the apical foramen. Utilizing the advantages of its well proven patented technology, RomiApex™... -
Page 4: Indications For Use
1. Indications for use RomiApex™ A-15 is an electronic device used for apex localization and working length determination during root canal treatment. RomiApex™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relative to the root apex. -
Page 5: Precautions
3. Precautions Verify that the canal has been properly isolated and that there are no metallic restorations present which may contact the file. Normally RomiApex™ A-15 provides accurate measurements during foramen location in dry and wet canals, in presence of various electrolytic solutions (Sodium Hypochlorite, EDTA, saline, etc.). -
Page 6: Package Contents
4. Package Contents Check the contents of the package before use: 1 RomiApex™ A-15 ● 1 Cradle ● 1 AAA 1.5V Alkaline Battery ● 1 Measuring cable ● 2 File clips ● 5 Lip clips ● 1 Touch probe ● 1 Screwdriver (for battery compartment) ●... -
Page 7: Getting Started
5. Getting Started 5.1. General There are two buttons on the front panel: On/Off Volume adjustment The measuring cable receptacle is located on the left side of the device. The battery compartment is located on back of the device. The RomiApex™ A-15 may be placed in or out of the cradle. The lip clip, the touch probe and the file clip should be sterilized before use. -
Page 8: Cable Connection Test
5.2.2. When the battery level is low, the flashing Low Battery indicator will appear on the RomiApex™ A-15 screen (Fig.2). will continue normal operation even with a low battery, but the battery should be replaced before it loses all power. Fig. -
Page 9: Device Operation
5.4. Device operation Do not use this unit with patients who have a pacemaker, as its effect has not been evaluated. 5.4.1. Place rubber dam prior to beginning endodontic treatment. 5.4.2. Obtain an initial radiograph and measure the distance between a reference point (i.e. - Page 10 5.4.11. Movement of the file inside the canal is reflected by the DOWN (Fig. 5) and UP (Fig. 6) arrows on the screen. 5.4.12. Continue to advance the file moving it smoothly in a watch-winding motion. As the instrument progresses toward the foramen, color segments inside the root canal image accompanied by audio signals with varied frequency will indicate the file’s progress.
- Page 11 5.4.13. Reaching the apical foramen (0.0) is indicated by a red color segment inside the root canal image (Fig. 10) and a constant audio tone. Determine the electronically obtained length using an endodontic ruler. To establish the working length, subtract 0.5 - 1.0mm from the electronic length. Foramen (red) (Red) Fig.
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Page 12: Audio Feedback
5.4.14. The file clip may be disconnected from the file and connected back during measurement without affecting normal device operation (for instance, when the file is changed to a larger number during root canal treatment or when another canal should be measured). In such cases the device detects automatically that the new measurement is initiated, the electrical contact and conductivity of the root canal are checked again and two beeps are sounded. -
Page 13: Demo Mode
6. Demo mode The built-in Demo mode is available to demonstrate operation of the device. 6.1. Disconnect the measuring cable from the device and turn the device off. 6.2. To start Demo mode, press and hold the On/Off key for about 1 sec. until the second beep sounds and “Demo”... - Page 14 7.2. Disinfection and sterilization procedure Operation Instructions Details and Warnings Preparation at the No particular point of use prior requirements. to processing Preparation for No particular decontamination/ preparation before requirements. cleaning The accessories are Cleaning: not intended for Automated automated cleaning. - The file clip should be pressed and released several times Clean the accessories...
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Page 15: Troubleshooting Guide
Operation Instructions Details and Warnings - Drying time after - The only sterilization sterilization – 30 parameters to be used are minutes. those that have been provided in this Manual. Keep devices in Sterility cannot be guaranteed if sterilization packaging packaging is open or damaged Storage in a dry and clean... - Page 16 Problem Possible Solution when touching the file - If the behavior persists, the measuring cable may need to clip and the lip clip be replaced and/or the device should be sent in for service – contact your supplier. - The file tip has progressed beyond the apical foramen – The OVER move the file back until the OVER indication disappears.
- Page 17 Problem Possible cause Solution Is there vital inflamed If a large amount of vital inflamed pulp tissue left inside pulp tissue is left inside the canal, the canal? particularly in wide canals such as upper incisors and canines, it may cause incorrect measurements.
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Page 18: Certification
The warranty is in lieu of any other warranty expressed or implied. Any modifications made to the equipment without explicit approval from Romidan Ltd. voids warranty obligations and poses a potential safety threat to both operator and patient. -
Page 19: Disclaimer
12. Disclaimer The manufacturer, its representatives and its dealers shall have no liability or responsibility to customers or any other person or entity with respect to any liability, loss or damage caused or alleged to be caused directly or indirectly by equipment sold or furnished by us, including, but not limited to, any interruption of service, loss of business or anticipatory profits, or consequential damages resulting from the use or operation of the equipment. -
Page 20: Electromagnetic Declarations
14. Electromagnetic declarations (IEC 60601-1-2) Table 1: Guidance and Manufacture’s Declaration for Electromagnetic Emissions The RomiApex™ A-15 is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. Electromagnetic environment - Emissions Test Compliance... - Page 21 (IEC 60601-1-2) Table 2: Guidance and Manufacture’s Declaration for Electromagnetic Immunity The RomiApex™ A-15 is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. IMMUNITY test IEC 60601 test Compliance Electromagnetic environment...
- Page 22 (IEC 60601-1-2) Table 4: Guidance and Manufacture’s Declaration for Electromagnetic Immunity for non-life support systems The RomiApex™ A-15 is intended for use in the electromagnetic environment specified below. The customer or user should ensure that it is used in such an environment. IMMUNITY IEC 60601 test Electromagnetic environment...
- Page 23 (IEC 60601-1-2) Table 6: Recommended separation distances between portable and mobile RF communications equipment and not life supporting equipment The RomiApex™ A-15 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RomiApex™ A-15 can help prevent electromagnet interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RomiApex™...
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Page 24: Standard Symbols
15. Standard symbols On the device labeling appear standard symbols as follows: Special disposal of waste Follow instructions electrical and electronic for use equipment Type BF applied Direct current 1.5V part Manufacturer Serial Number Caution: Federal law restricts this device to sale by or on the order of a physician or licensed dental practitioner... - Page 25 RomiApex A15 Rev. 07 – 04/14 Manufacturer: Romidan Ltd. 5 Simcha Holzberg St., 55022 Kiryat Ono, Israel Email: export@romidan.com www.romidan.com...
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