Medidenta Sonus User And Operating Manual

Ultrasonic scaler

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User and Operating Manual

LED Piezo U l trason ic Sca ler

Medidenta

Toll Free: 800.221.0750

Web: www. Medidentaendo.com

Email: Orders@medidenta.com

3575 W. Post Rd. , Las Vegas, NV 89118

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Page 1 Read this manual carefully before operating. Keep it in a safe place for further consultation User and Operating Manual LED Piezo U l trason ic Sca ler Medidenta Toll Free: 800.221.0750 Web: www. Medidentaendo.com Email: Orders@medidenta.com 3575 W. Post Rd. , Las Vegas, NV 89118...
Page 2: Table Of Contents
Contents 1. Installation. Components description ........... 3 2. Installation. Setup ................7 3. Maintenance. Troubleshooting ............ 16 4. Cleaning, disinfection and sterilization ........20 5. Precautions. Contraindications………………………………..27 6. After service ................... 32 7. Symbols instructions ..............33 8. Environmental protection ............. 34 9.
Page 3: Installation. Components Description
Do not use dry heat sterilization on any of the device’s components. Components description The components are listed in the packing list. 1.2.1 Sonus LED Piezo Ultrasonic Scaler is composed of circuit board, 1.2.2 water pump, reservoir (tank and accessory bottles), and ultrasonic transducer handpiece.
Page 4 such as hygiene, periodontics, endodontics, implant maintenance and cavity preparations. Technical specifications LED Piezo Ultrasonic Scaler: 1.3.1 Main unit input: 110V~ 50Hz/60Hz 2 8 0 mA. Output primary tip vibration excursion: ≤ 9 0μm. Output half-excursion force: <2N. Output tip vibration frequency: 28 kHz±3kHz. Output power: 3W to 20W.
Page 5 Main components 1.4.2 Main unit (front) Fig. 1. Front view details. Main unit (back) Fig. 2. Back view details.
Page 6 Handpiece components Fig. 3. Handpiece. Handpiece/handpiece cable coupling Fig. 4. Handpiece and handpiece cable connection alignment guides matching. Tip installation. Torque Wrench/ Wrench Fig. 5. Torque wrench and wrench.
Page 7: Installation/Setup
Touch screen display with water, vibration and power (amplitude) controls. Fig. 6. Touch screen display. Accessory bottles. Fig. 7. Accessory bottles (300 ml maximum) for irrigants. 2. Installation/Setup Unpacking the device WARNING: When you receive your medical device, check for any damage that may have occurred during transportation.
Page 8 Check that the power voltage is compatible with that indicated on the device or its power plug. WARNING: Sonus voltage is 110V, 50-60Hz, 280 mA. Next, connect the cord to the wall socket in compliance 2.1.7 with the standards in force in the country of use.
Page 9 Fill the reservoir up to the line with distilled water. Do not 2.1.14 overfill. With reservoir/bottles in place, press the reservoir mode button on the touch panel (Fig. 6). Sonus comes with accessories bottles (Fig. 7) to be used 2.1.15 during endodontic irrigation. Place the bottle for different solutions...
Page 10 (E) tips, use the wrench (both included). WARNING: The screw thread of the tips produced by other manufacturers maybe coarse, rusty and collapsed, which will damage the screw thread of the handpiece irretrievably. Please use Medidenta brand tips. Turn on the power switch (Fig. 2). 2.1.17...
Page 11 E stands for endodontic tip; letter D stands for S type screw design tip. WARNING: Always use S type tips for Sonus. It is highly recommended to use Medidenta ultrasonic tips with the Sonus LED Piezo Ultrasonic Scaler. Do not use E type tips (consult tip instructions for use before using ultrasonic tips).
Page 12 tips. Choose the vibration intensity mode (G, P or E) based on the 2.1.21 procedure/tip you are willing to perform (Fig. 6). IMPORTANT: Pressing twice the E button the system will go to irrigation mode (E mode at power amplitude 3). This feature allows the proper set for polymer irrigation tips.
Page 13 Operating power adjustment (scale number from 1 to 10): 2.1.24 always start the power at a minimal rate (1), adjusting/increasing during clinical treatment according procedure development. Various factors need to be evaluated such as patient's sensitivity, and/or volume of calculus, among others. WARNING: Consult “Tips Power Table”...
Page 14 After finishing operation, remove the reservoir 2.1.26 dispose the remaining irrigant. Rinse the tank with water. Fill the tank with distilled water to a quarter of its capacity. Reinstall the tank. Start the cleaning mode by simultaneously the two buttons on pressing the touch screen panel (water line mode and reservoir...
Page 15 cleaning mode (purge) cycle. A continuous flow volume of distilled water will clean the system internally, preventing corrosion or mineral accumulation automatically for 30 seconds. Step on the foot switch pedal for ending the cleaning mode cycle before 30 seconds if necessary. After the cleaning cycle, press again the two buttons simultaneously to exit cleaning mode.
Page 16: Maintenance. Troubleshooting
The foot switch is in Insert the foot switch to loose contact. its socket tightly. Internal fuse is not Contact Medidenta. working. The tip doesn't The tip is in loose Make sure that the vibrate but there is contact.
Page 17 Replace taking longer or is with a S type at a standstill. (Medidenta recommended) and screw the tip on the handpiece tightly. The tip is loose. Screw on the tip tightly. The coupling between...
Page 18 The water pipe is syringe jammed. [note2]. The vibrating The potentiometer is Contact intensity control damaged. Medidenta. knob is seized Poor contact. Contact tightly. LED worn. Replace the LED. LED light is off. If the problem still can't be solved, contact Medidenta.
Page 19 Corrective maintenance In the event of faulty operation, the following corrective maintenance actions may be performed by the user. Clean the water pipe with the air-water syringe (Fig. 11): 3.2.1 Fig. 11. Water line at the back of the unit. a.
Page 20: Cleaning, Disinfection And Sterilization
b. A single beep alarm will sound and the reservoir mode button will start to blink. Step on the foot switch once to start cleaning mode (purge) cycle. A continuous flow volume of distilled water will clean the system internally, preventing corrosion or mineral accumulation automatically for 30 seconds.
Page 21 parameters are adhered to during every cycle. Also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic, especially with regard to the additional requirements for the inactivation of prions. Post-operation treatment 4.1.2 The post-operation treatment must be carried out immediately, no later than 30 minutes after the completion of the operation.
Page 22 Cleaning The cleaning should be performed no later than 24 hours after the operation. The cleaning can be divided into automated cleaning and manual cleaning. Automated cleaning is preferred if conditions permit. Automated cleaning 4.3.1 •The cleaner is proved to be valid by CE certification in accordance with EN ISO 15883.
Page 23 EN ISO 15883. Cleaning and disinfecting steps by using Washer-disinfector a. Carefully place the product into the disinfection basket. Fixation of product is needed only when the product is removable in the device. The products are not allowed to contact each other. Use a suitable rinsing adaptor, and connect the internal water lines to the rinsing connection of the washer-disinfector.
Page 24 • Only distilled or deionized water with a small number of microorganisms (<10 cfu/ml) can be used for all rinsing steps. (i.e., pure water that is in accordance with the European Pharmacopoeia or the United States Pharmacopoeia). • After cleaning, the chemical residue should be less than 10mg / L. •...
Page 25 Check the product. If it is obviously damaged, smashed, 4.6.2 detached, corroded or bent, it must be scrapped and not allowed to continue to be used. Check the product. If the accessories are found to be damaged, 4.6.3 please replace it before use. And the new accessories for replacement must be cleaned, disinfected and dried.
Page 26 Verification of the fundamental suitability of the products for effective steam sterilization was provided by a verified testing laboratory. WARNINGS: • Only products that have been effectively cleaned and disinfected are allowed to be sterilized. • Before using the sterilizer for sterilization, read the Instruction Manual provided by the equipment manufacturer and follow the instructions.
Page 27: Precautions. Contraindications
4.10 Transportation Prevent excessive shock and vibration during transportation, 4.10.1 handle with care. It should not be mixed with dangerous goods during 4.10.2 transportation. Avoid exposure to sun or rain or snow during transportation. 4.10.3 Cleaning and disinfection of main unit 4.11 •...
Page 28 handpieces in accordance with the power levels defined. • However, tips may break depending on frequency of use, force exerted or by being dropped. • To reduce all risk (however minimal) t is recommended the use of a high suction device such as a saliva suction cannula. You should also encourage your patient to breathe through the nose.
Page 29 5.1.15 responsible for the safety on the following conditions: Ⅰ. The maintenance, repair and modification are made by the manufacturer. Ⅱ . The changed components are original of Medidenta and operated correctly according to instruction manual. The screw thread of the tips...
Page 30 use this equipment. WARNING: Interferences may occur when the system is used on patients fitted with a pacemaker. The medical device presents potential risks due to the emission of electromagnetic fields. It may in particular cause malfunction of implanted devices such as a pacemaker or implantable defibrillator and, generally, of any type of active implant.
Page 31 If necessary, contact Medidenta. Never cover the medical device and/or obstruct the air inlets. 5.2.6 Do not immerse or use outside. 5.2.7 Do not place the medical device next to a source of heat or in 5.2.8...
Page 32: After Service
6. After service Medidenta International Inc. offers one year of free repair to the equipment after purchase according to the warranty card. The repair of the equipment should be carried out by Medidenta’s professional technical support/maintenance department.
Page 33: Symbols Instructions
7. Symbols instructions Trademark Earth ground Alternating current Ordinary equipment IPX0 Date of manufacture CE market product Type B applied part Use indoor only Manufacturer Sterilizable up to the temperature Class II equipment Water entrance pressure Water line (irrigant) flow Follow instructions for use adjustment Water line mode...
Page 34: Environmental Protection
8. Environmental protection Please dispose according to the local laws. An accessory that 8.1.1 has reached the end of its service life must be disposed of in infectious clinical waste containers. 9. Manufacturer’s liability We reserve the rights to change the design of the equipment, the technique, fittings, the instruction manual and the content of the original packing list at any time without notice.
Page 35: Emc - Declaration Of Conformity
Guidance and manufacturer’s declaration - electromagnetic emissions The models Sonus, D600, D600 LED are intended for use in the electromagnetic environment specified below. The customer or the user of the models D600, D600 LED should assure that it is used in such an environment.
Page 36 Guidance & Declaration — electromagnetic immunity The models Sonus, D600, D600 LED are intended for use in the electromagnetic environment specified below. The customer or the user of the models Sonus, D600, D600 LED should assure that It is used in such an environment.
Page 37 The models Sonus, D600, D600 LED are intended for use in the electromagnetic environment specified below. The customer or the user of the models D600, D600 LED should assure that it is used in such an environment. IEC 60601 test...
Page 38 The models Sonus, D600, D600 LED are intended for use in electromagnetic environment in which radiated RF disturbances is controlled. The customer or the user of the models Sonus, D600, D600 LED can help prevent electromagnetic interference by maintaining a...
Page 39: Statement
All rights of modifying the product are reserved to the manufacturer without further notice. The pictures are only for reference. The final interpretation rights belong to Medidenta. The industrial design, inner structure, etc., have claimed for several patents by the primary manufacturer, any copy or fake product must take...
Page 40: Tips Power Table
TIPS POWER TABLE (OPERATING POWER) Scaling Endodontics Tip Model Power Tip Model Power 1-10(G) 1-6(E) 1-10(G) ED3D 1-3(E) GD4D 1-10(G) 1-6(E) 1-10(G) ED4D 1-3(E) 1-10(G) 1-6(E) 1-10(G) ED5D 1-3(E) 1-10(G) 1-6(E) 1-10(G) 1-6(E) GD10 1-10(G) 1-10(E) GD11 1-10(G) 1-10(E) GD12 1-10(G) ED10 1-6(E)
Page 41 Scan and login Medidenta’s website for more information. www.medidentaendo.com Manufactured for: Medidenta Toll Free: 800.221.0750 E-mail: orders@medidenta.com 3575 W Post Road, Las Vegas, NV 89118, USA casr...