Medidenta Sonus User And Operating Manual Download Page 1

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Medidenta

Toll Free: 800.221.0750

Web: www. Medidentaendo.com

Email: [email protected]

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

LED Piezo U l trason ic Sca ler

User and Operating Manual

Read this manual carefully before operating.

Keep it in a safe place for further consultation

Summary of Contents for Sonus

Page 1: ... Web www Medidentaendo com Email Orders medidenta com 3575 W Post Rd Las Vegas NV 89118 LED Piezo Ultrasonic Scaler User and Operating Manual Read this manual carefully before operating Keep it in a safe place for further consultation ...

Page 2: ...16 4 Cleaning disinfection and sterilization 20 5 Precautions Contraindications 27 6 After service 32 7 Symbols instructions 33 8 Environmental protection 34 9 Manufacturer s liability 34 10 European authorized representative 34 11 EMC Declaration of conformity 35 12 Statement 39 13 Tips Power Table 40 ...

Page 3: ...d for preservation and restoration dentistry including hygiene periodontics endodontics implant maintenance restorative and prosthesis WARNINGS Read all instructions before operating this unit The manufacturer accepts no liability for any damage resulting from improper use of this unit and or for any purpose other than those covered by these instructions US Federal law restricts this unit to sale ...

Page 4: ...Weight of main unit 3 97 pounds 1 8 Kg i Operating mode Continuous operation j Type of protection against electric shock class II equipment k Degree of protection against electric shock Type BF applied part l Applied part of the equipment handpiece and tip Degree of protection against harmful ingress of water ordinary equipment Foot switch is drip proof equipment IPX1 m Degree of safety of applica...

Page 5: ...5 1 4 2 Main components Main unit front Fig 1 Front view details Main unit back Fig 2 Back view details ...

Page 6: ...iece 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: ...ion Setup 2 1 Unpacking the device WARNING When you receive your medical device check for any damage that may have occurred during transportation If you have received this medical device by mistake please contact the supplier to arrange for it to be collected 2 1 1 Open the packing box Make sure that all parts and accessories are complete according to the packing list Take the main ...

Page 8: ...ltage is 110V 50 60Hz 280 mA 2 1 7 Next connect the cord to the wall socket in compliance with the standards in force in the country of use 2 1 8 A different voltage would cause damage to the medical device and could injure the patient and or user Any variation in the electrical network voltage or electromagnetic field that is non compliant with the limits in force could interfere with the medical...

Page 9: ... periodontics treatments Follow dental unit manufacturer s instructions for maintaining and monitoring the quality of dental unit water 2 1 13 With the water connections in place press the water line mode button on the touch panel Fig 6 If you are going to use the reservoir tank or bottles WARNING The device is equipped with a reservoir tank and accessory bottles Fig 7 designed to hold the irrigat...

Page 10: ...pg 40 and install it using the torque wrench Fig 5 For install endodontic 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 2 1 17 Turn on the power switch Fig 2 WARNING Every time that the device is turn off and t...

Page 11: ...intensity model starting with G scaling hygiene P periodontics E endodontics and SB for cavity preparation The second letter refers to the screw design type Fig 9 Fig 9 Example of Sonus tip with the number letters code identification Letter 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 ultr...

Page 12: ...ise counterclockwise If you are using the water line mode turn the water line flow control knob Fig 2 clockwise counterclockwise Adjust the knob to achieve a suitable irrigant spray to cool down the handpiece and helps to rinse the treatment area This adjustment depends on the tip design and procedure As work habits feedback and professional training differ from one professional to another the use...

Page 13: ...ng the ED70 connector These tips need to be activated turned on only when inside the canal with operating power level from 1 minimum to 3 maximum 2 1 25 Start the ultrasonic vibration stepping on the foot switch pedal Once the tip begins to vibrate a LED light on the top of the handpiece Fig 3 turns on Once the foot switch is released the LED ilumination will stay on for 10 seconds When using hygi...

Page 14: ... cycle before 30 seconds if necessary After the cleaning cycle press again the two buttons simultaneously to exit cleaning mode 2 1 27 Unscrew the tip verify any worn or distortion Clean and sterilize it WARNING Do not screw unscrew tips when the device is on stepping on the foot switch pedal 2 2 Cleaning mode purge cycle It is important to clean internally purge the device after use to prevent co...

Page 15: ...ary After the cleaning cycle press again the two buttons simultaneously to exit cleaning mode WARNING Cleaning mode purge cycle needs to be done always after the use of reservoir tank or accessory bottles Do not leave irrigants water inside the reservoir bottles after use Discard the irrigants used in a proper way Special attention with corrosive irrigants like sodium hypochlorite is need Do not u...

Page 16: ...al fuse is not working Contact Medidenta The tip doesn t vibrate but there is water flowing out when stepping on the switch The tip is in loose contact Make sure that the right tip S type is being used Screw the tip on the handpiece tightly Handpiece and handpiece cord are in loose contact Make sure there is no gap between the handpiece and the handpiece cord coupling The tip vibrates but there is...

Page 17: ...d screw the tip on the handpiece tightly The tip is loose Screw on the tip tightly The coupling between the handpiece and the handpiece cord isn t dry Thoroughly fry the electrical contacts The tip is damaged Replace the tip Polymer tip is melting at the end part of the tip Excessive heat during vibration Do not activate turn on the tip outside the canal Use the right vibration E mode and the righ...

Page 18: ... 1 The water pressure is not enough Enhance the water pressure The water pipe is jammed Clean water pipe with air water syringe note2 The vibrating intensity control knob is seized up The potentiometer is damaged Contact Medidenta LED light is off Poor contact Contact tightly LED worn Replace the LED If the problem still can t be solved contact Medidenta ...

Page 19: ...crew off the tip or pull out the handpiece e Step on the foot switch f Turn on the air water syringe pressing air or water into the water pipe to unblock the system 3 3 Cleaning mode It is important to purge the system after use preventing corrosion or mineral deposits alongside the internal system 3 3 1 Operation a After finishing operation remove the reservoir and dispose the remaining irrigant ...

Page 20: ...ll reduce the life span of products And in such cases the manufacturer takes no responsibility Do not clean the handpiece with ultrasound cleaning machine This device shall not be exposed to high temperature above 138 Processing limit The products have been designed for a large number of sterilization cycles The materials used in manufacture were selected accordingly However with every renewed pre...

Page 21: ...eionized water c Dry the product with a clean soft cloth and place it in a clean tray WARNING The water to be used to clean must be pure water distilled water or deionized water 4 2 Preparation before cleaning Tools Torque wrench tray soft brush clean and dry soft cloth a Remove the tip from handpiece with torque wrench or wrench provided and then put the tip and wrench into a clean tray b Unscrew...

Page 22: ...he next section Disinfection WARNINGS The cleaning agent can be distilled water deionized water or multi enzyme Make sure that the selected cleaning agent is compatible with the product In washing stage the water temperature should not exceed 45 C otherwise the protein will solidify and it would be difficult to remove After cleaning the chemical residue should be less than 10mg L 4 4 Disinfection ...

Page 23: ...ection process and precautions With this equipment cleaning disinfection and drying will be carried out together Cleaning c1 The cleaning procedure should be suitable for the product to be treated The flushing period should be sufficient 5 10 minutes Pre wash for 3 minutes wash for another 5 minutes and rinse it for twice with each rinse lasting for 1 minute c2 In the washing stage the water tempe...

Page 24: ...essed air maximum pressure 3 bar Until no liquid is sprayed onto the white paper white cloth the product drying is completed b It can also be dried directly in a medical drying cabinet or oven The recommended drying temperature is 80 120 and the time should be 15 40 minutes IMPORTANT The drying of product must be performed in a clean place The drying temperature should not exceed 138 C The equipme...

Page 25: ...ge used conforms to ISO 11607 b It can withstand high temperature of 138 C and has sufficient steam permeability WARNING The packaging environment and related tools must be cleaned regularly to ensure cleanliness and prevent the introduction of contaminants Avoid contact with parts of different metals when packaging 4 8 Sterilization Use only the following steam sterilization procedures fractional...

Page 26: ...w temperature plasma sterilization The manufacturer assumes no responsibility for the procedures that have not been recommended If you use the sterilization procedures that have not been recommended please adhere to related effective standards and verify the suitability and effectiveness 4 9 Storage 4 9 1 Store in a clean dry ventilated non corrosive atmosphere with a relative humidity of 10 to 93...

Page 27: ...cable and cable with a soft cloth soaked in clean water distilled or deionized water or a clean disposable wipe Repeat the wipe for at least 3 times 5 Precautions 5 1 Usage notice 5 1 1 Keep the scaler clean before and after operation 5 1 2 The tip torque wrench wrench and handpiece must be sterilized before each treatment 5 1 3 Don t screw the tip when stepping on the foot switch 5 1 4 The tip mu...

Page 28: ...ub the handpiece 5 4 11 After each clinical operation with different irrigants fill the reservoir with distilled water proceed the cleaning mode for 30 seconds in order to keep the water way and spare parts clean and durable 5 1 12 Locate the power plug into the socket easy to pull out to make sure it can be pull out in emergency WARNINGS For devices connected to the water line shut off the dental...

Page 29: ...erator The medical device will perform best if the user pays attention to these two characteristics Therefore we strongly advise against the modification of the structure of the tips by filing twisting or by performing other types of modification In addition tip ageing leading to normal wear can modify the tip characteristics Systematically replace a tip that is damaged due to wear or accidental i...

Page 30: ...l symptoms such as an increased heartbeat irregular pulse or dizziness may indicate a malfunction of a pacemaker or an implantable defibrillator The medical device is not designed to withstand electrical defibrillation shocks 5 2 3 The heart disease patient pregnant woman and children should be cautious to use the equipment 5 2 4 The medical device was designed and developed with its accessories t...

Page 31: ...must always be closed when the medical device is in use 5 2 14 Use the medical device with bottles that do not exceed the maximum levels recommended for the medical device depending on option 5 2 15 To prevent any interaction such as crystallization or precipitate between the different irrigation solutions used rinse through the irrigation circuit and clean the tank in accordance with the instruct...

Page 32: ...ation and getting wet in rain or snow during transportation 5 5 Working condition 5 5 1 Environment temperature 5 C to 40 C 5 5 2 Relative humidity 30 75 5 5 3 Atmosphere pressure 70kPa to 106kPa 5 5 4 Temperature of the water irrigant at the inlet not higher than 25 C 5 5 5 An accessory that has reached the end of its service life must be disposed of in infectious clinical waste containers 6 Afte...

Page 33: ...the temperature Class II equipment Water entrance pressure Water line irrigant flow adjustment Follow instructions for use Water line mode Atmospheric pressure for storage Adjustment to reservoir mode water irrigant flow Humidity limitation for storage Reservoir bottle water irrigant mode 110V Voltage to be used Warning and precautions Important notes Food and Drug Administration US marked product...

Page 34: ...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 If there are some differences between blueprint and real equipment take the real equipment as the norm 10 European authorized representative 8 Environmental protection ...

Page 35: ...it is used in such an environment Emission s test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The models Sonus D600 D600 LED use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR11 Class B The models Sonus D600 D600 LED are suitable for use...

Page 36: ...kV line to earth 1 kV line to line Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 c...

Page 37: ... from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5 V1 P1 2 d 1 2 P1 2 80 MHz to 800MHz d 2 3 P1 2 800 MHz to 2 5GHz where P is the maximum output power rating of the transmitter In watts W according to the transmitter manufacturer and d Is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by...

Page 38: ...iated RF disturbances is controlled The customer or the user of the models Sonus D600 D600 LED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the models Sonus D600 D600 LED are recommended below according to the maximum output power of the communications equipment Rated maximum output power of...

Page 39: ...acturer 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 legal responsibilities ...

Page 40: ...9 1 10 G ED7 1 6 E GD10 1 10 G ED8 1 10 E GD11 1 10 G ED9 1 10 E GD12 1 10 G ED10 1 6 E GD30 1 10 G ED10D 1 6 E ED11 1 6 E Periodontics ED11D 1 6 E Tip Model Power ED12 1 6 E PD1 1 10 P ED12D 1 6 E PD2L 1 3 P ED14 1 3 E PD2LD 1 2 P ED15 1 3 E PD2R 1 3 P ED70 with Polysonic tip 1 3 E PD2RD 1 2 P PD3 1 6 P Cavity Preparation PD3D 1 6 P Tip Model Power PD4 1 6 P SBD1 1 10 P PD4D 1 6 P SBD2 1 10 P PD7...

Page 41: ...Scan and login Medidenta s website for more information Manufactured for Medidenta Toll Free 800 221 0750 E mail orders medidenta com 3575 W Post Road Las Vegas NV 89118 USA casr www medidentaendo com ...

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