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Premier / Premier Plus

30

8.2 EMC - Guidance and Manufacturer’s Declaration

The BioSonic Suvi uses RF energy only for its internal function.

Therefore, it's RF emissions are very low and are not likely to cause  

any interference in nearby electronic equipment. 

Group 1 

RF emissions 

CISPR 11 

RF emissions 

CISPR 11 

Class B 

The BioSonic Suvi is suitable for use in all establishments, including 

domestic establishments and those directly connected to the public  

low-voltage power supply network that supplies buildings used for  

domestic purposes. 

Harmonic emissions 

IEC 61000-3-2 

Not applicable 

Voltage fluctuations/ 

flicker emissions 

IEC 61000-3-3 

Not applicable 

Guidance and manufacturer's declaration - electromagnetic emissions 

Emission test

Compliance

Electromagnetic environment - guidance 

The BioSonic Suvi is intended for use in the electromagnetic environment specified below.
The customer or the user of the BioSonic Suvi should assure that it is used in such an environment.

The BioSonic Suvi is intended for use in the electromagnetic environment specified below.
The customer or the user of the BioSonic Suvi should assure that it is used in such an environment.

3 A/m

3 A/m 

 IEC 61000-4-8 

<5 %  

(>95 % dip in U 

for 0,5 cycle 

40 %  

(60 % dip in U 

for 5 cycles 

70 %  

(30 % dip in U 

for 25 cycles 

<5 %  

(>95 % dip in U 

for 5 sec 

±2 kV for power 

supply lines 
 ±1 kV for input/output  

lines 
±1 kV differential 

mode 
±2 kV common mode 

NOTE 

  is the a.c. mains voltage prior to application of the test level. 

Power frequency magnetic fields should  

be at levels characteristic of a typical  

location in a typical commercial or  

hospital environment. 

Mains power quality should be that of a  

typical commercial or hospital  

environment. 

Mains power quality should be that of a  

typical commercial or hospital  

environment. 

Power frequency 

(50/60 Hz) 

magnetic field 

±2 kV for power 

supply lines 
 ±1 kV for input/output  

lines 
±1 kV differential 

mode 
±2 kV common mode 

Electrical fast  

transient/burst 

Floors should be wood, concrete or  

ceramic tile. If floors are covered with  

synthetic material, the relative humidity  

should be at least 30%. 

Electromagnetic environment - 

guidance 

Electrostatic 

discharge (ESD) 

IEC 61000-4-2 

±6 kV contact 

±8 kV air 

±6 kV contact 

±8 kV air 

IEC 61000-4-4 

Surge 

IEC 61000-4-5 

<5 %  

(>95 % dip in U 

for 0,5 cycle 

40 %  

(60 % dip in U 

for 5 cycles 

70 %  

(30 % dip in U 

for 25 cycles 

<5 %  

(>95 % dip in U 

for 5 sec 

Guidance and manufacturer's declaration - electromagnetic immunity 

Mains power quality should be that of a  

typical commercial or hospital  

environment. If the user of the   

BioSonic Suvi requires continued 

operation during power mains

interruption, it is recommended that the  

BioSonic Suvi be powered from an 

uninterruptible power supply or battery. 

Immunity test 

IEC 60601 

test level 

Compliance level 

Voltage dips, short  

interruptions and 

voltage varaiations 

on power supply 

input lines  

IEC 61000-4-11 

Warranty and Declaration of Conformity

Содержание Suvi Premier

Страница 1: ...Ultrasonic Piezo Scaler Place Disk Owner s Guide...

Страница 2: ...53 BioSonic Suvi Premier Plus Medicament feeder AUS Plug Type I 230 60014254 Shaded and italicized items in the table above are not currently offered for sale Important Read this manual carefully befo...

Страница 3: ...Premier Premier Plus 3...

Страница 4: ...4 2 How to use the scaler 19 4 3 After treatment 19 Automatic cleaning function 19 5 Cleaning and Maintenance 20 5 1 Cleaning of the equipment and components 20 Cleaning 20 Disinfecting 20 Drying 20...

Страница 5: ...Premier Premier Plus 5...

Страница 6: ...EMC information provided in section 8 2 Portable and mobile RF Radio Frequency communications equipment can affect the product Contraindications Do not use the scaler on patients with cardiac pacemak...

Страница 7: ...ning indicates a potentially dangerous situation Non observance may lead to death or injury Caution indicates a potentially harmful situation Non observance may damage the equipment Note indicates a s...

Страница 8: ...features of the equipment read Equipment description section 2 6 Caution indicates a potentially harmful situation Non observ ance may damage the equipment Note indicates a situation where special not...

Страница 9: ...soft silicone removable grips give the user a comfortable relaxed grip as well as an excellent feel BioSonic Suvi Premier Premier Plus is highly adaptable to any procedure or user approach It is not o...

Страница 10: ...POWER OFF key 4 Working mode 1 key 0 to 40 power 5 Working mode 2 key 0 to 70 power 6 Working mode 3 key 0 to 100 power 7 StandBy indicator 8 POWER ON indicator 9 Dry mode indicator 10 Irrigation mod...

Страница 11: ...12 OFF position 13 ON position 14 Diagnostic function turn LED light ON or OFF by a single click on the pedal 15 Irrigation position 16 Zero power position 17 Maximum power position 18 Power regulati...

Страница 12: ...The medicament bottle can be used for either medicament solutions or ordinary clean water The unit contains an electrically driven air compressor When operating the unit the compressed air forces the...

Страница 13: ...unit Caution Consult accompanying documents Type B applied part according to the degree of protection against electrical shock Fuse Input Output This appliance is labeled in accordance with European...

Страница 14: ...zed Representative IPX1 Ingress Protection Rating Device has dripping water protection Date of Manufacture Autoclave at 132o C Caution Federal United States laws restricts this device to sale by or on...

Страница 15: ...unit in the immediate vicinity of sources of electromagnetic radiation for example the Perfect TCS II or other electrosurgery equipment Connect the foot pedal cable to the foot control pedal and at th...

Страница 16: ...t the voltage rating on the rear side matches the voltage of the AC power outlet Verify that the AC power outlet is provided with a protective ground Connect the power cord to the unit and the AC powe...

Страница 17: ...ormance and must be exchanged Prolonged use may cause tip breakage and injury to the patient The operator should be aware that ultrasonic instruments with small diameters are subject to breakage at an...

Страница 18: ...the ON button activates the dry mode for scaling without water medicament 7 A third press of the ON button activates the irrigation mode The irrigation mode can also be activated in the scaling mode b...

Страница 19: ...t a squeaking sound is heard loud and dominating the pressure against the tooth might be too low or the tip not parallel to the surface of the tooth To keep the tip working parallel to the surface of...

Страница 20: ...ar broken tip or distortion is noted 3 Clean thoroughly using an ultrasonice cleaner such as the Colt ne Whaledent BioSonic Ultrasonic Cleaning System with BioSonic UC32 Solution Concentrate Disinfect...

Страница 21: ...o rinse the lines from cleaning agent solution put clean water in the bottle and run the automatic cleaning cycle until clean water comes out of the handpieces Sterilizing Package in an FDA approved w...

Страница 22: ...s 1 Disconnect the power cord from the AC power outlet and the unit 2 Open the fuse holder on the rear side of the unit 3 Inspect the fuses for damage Replace damaged fuses with new ones Verify the fu...

Страница 23: ...nd the fuse panel are OK 4 If the problem still remains contact your dealer for support and indicate Error Code E X02 Type of problem Please see A Unit is not responding and no lights are lit on the c...

Страница 24: ...ration 1 Check that the tip is firmly tightened Preferably use a torque wrench and tighten clockwise until the torque wrench slides The torque wrench prevents the tip from being over tightened 2 Check...

Страница 25: ...y another tip 6 If the problem still remains contact your dealer for support and indicate Error Code E S04 F Tip does not fit smoothly onto the handpiece 1 Clean handpiece threads with compressed air...

Страница 26: ...00 g Voltage 100 Vac 50 60 Hz 115 Vac 50 60 Hz 230 Vac 50 60 Hz Primary fuse T500 mAH 250 V 5x20 mm 100 Vac T400 mAH 250 V 5x20 mm 115 Vac T200 mAH 250 V 5x20 mm 230 Vac Power cord Separate with prote...

Страница 27: ...angurinara extract Sodium hypochlorite 1 solution WARNING Immedately after using any kind of medicament in the medicament bottle run the automatic cleaning cycle with clean water in the medicament bot...

Страница 28: ...nt products are manufactured from new parts or new and serviceable used parts Regardless our warranty terms apply The products are guaranteed in accordance with the terms of the written Certificate of...

Страница 29: ...antability and fitness for a particular purpose In no event shall C W be liable for direct indirect tort exemplary punitive special incidental or consequential damages arising from the possession or u...

Страница 30: ...output lines 1 kV differential mode 2 kV common mode NOTE U T is the a c mains voltage prior to application of the test level Power frequency magnetic fields should be at levels characteristic of a ty...

Страница 31: ...ic immunity Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the BioSoni...

Страница 32: ...nt in which radiated RF disturbances are controlled The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobil...

Страница 33: ...i Grip Color Lilac 4 60018765 Suvi Grip Color Pink 4 60018766 Suvi Grip Color Blue 4 60019328 Subgingival Nozzel 1 60018486 Polisher Nozzle Hooked 1 60018485 Polisher Nozzle Universal 1 60014456 Torqu...

Страница 34: ...283 PE 40R General Scaling 60014284 PE 40H General Scaling 60019608 PE 40HS General Scaling 60014285 PE 41PS General Scaling 60014286 IM 1 Scaling Implant maintenance 4 pk 60014287 IM 2 Scaling Implan...

Страница 35: ...Premier Premier Plus 35...

Страница 36: ...ne Whaledent AG Feldwiesenstrasse 20 9450 Altst tten Switzerland Tel 41 0 71 757 53 00 Fax 41 0 71 757 53 01 info ch coltene com Colt ne Whaledent GmbH Co KG Raiffeisenstrasse 30 89129 Langenau Germa...

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