ProUltra Piezo Ultrasonic Instructions for Use

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instructions for use

Contents Introduction...

1. Safety Information... 08 2. Standard Components...10 3. Description... 10 4. Step-by-step Instructions... 11 4.1. Installation... 11 4.2. Before Operating the Unit... 11 4.3. Operating the Unit... 12

4.3.1. Endodontic Applications... 12

4.3.2. Other Applications... 13

4.4. After Operating the Unit... 14 5. Sterilization and Replacement Parts... 14 5.1. Autoclavable Components... 14

5.1.1. Handpiece... 14

5.1.2. Tips... 14

5.2. Non-Autoclavable Components... 15 5.3. Replacement Parts... 15 6. Maintenance... 16 6.1. Handpiece Maintenance... 16 6.2. Tip Maintenance... 16 6.3. Control Unit Maintenance... 17 6.4. Water Filter Replacement and Maintenance... 17 7. Troubleshooting... 18 8. Technical/Performance Data... 19 9. Disposal and Recycling... 20 10. Warranty... 20

APPENDIX 11. Electromagnetic Compatibility... 22 11.1. Electromagnetic Emissions... 22 11.2. Electromagnetic Immunity... 23 11.3. Electromagnetic Immunity/Mobile Radiofrequency Equipment . . 24 11.4. Recommended Separation Distances... 25 11.5. Cable Lengths... 26

FIG. 2 Front panel

12 13

18 8

3 11 12

7 6 5

2 13

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17 1

POWER ON

18 19 OF

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2. ON/OFF LED

10 9

3. ON/OFF adjustment knob 4. Handpiece holder 5. Handpiece 6. Handpiece cord 7. Water spray adjustment knob

FIG. 1 Overview

1. Foot pedal

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FIG. 3 REAR panel

Thank you for purchasing the ultrasonic device.

Rx Only

Indications for use

This symbol found on labels of the unit and accessories reminds you to consult this User Manual.

The ProUltra® Piezo Ultrasonic is a piezo-electric ultrasonic generator that uses ultrasonic tips to carry out dental treatments, especially designed to assist with root canal treatments. In order to receive the most out of this high technology product, and prolong its life, we ask you to read these instructions carefully before using the device for the first time. The User Manual is supplied for safety reasons and must be considered as an integral part of the system. We recommend always keeping it close at hand.

This symbol applies to US and Canada Only.

Notes

• Changes to the content of these instructions are reserved without prior notice.

It is of the utmost importance that this manual be retained for future consultation. Please do not hesitate to contact DENTSPLY Tulsa Dental Specialties for help with any doubt or problem that may arise during consultation of this Instructions for Use.

Distributed By : DENTSPLY Tulsa Dental Specialties DENTSPLY International, Inc. 608 Rolling Hills Drive Johnson City, TN 37604 1-800-662-1202 1-800-597-2779 (fax) www.tulsadentalspecialties.com Manufactured By : Satelec, a company of ACTEON group 17 Ave. Gustave Eiffel, BP 30216 33708 Merignac, Cedex, France www.acteongroup.com

0459

1. Safety Information

General Precautions

Note the meaning of the following symbols:

Take the following precautions to reduce the risk of any accident:

Alternating current Protection class II Shock Type BF Consult instructions for Use; if the instructions are not being followed properly, operation may result in hazards for the product or the user/patient.

• The ProUltra Piezo Ultrasonic is designed for dental use only by trained and qualified practitioners such as dentists and hygienists. • The device has been developed to be used with DENTSPLY Tulsa Dental Specialties ProUltra endodontic tips and Satelec’s Ultrasonic tips. For hygienic, prophylactic and general purposes Satelec® periodontic and scaling tips can also be used with the ProUltra Piezo Ultrasonic. Using tips from manufacturers other than DENTSPLY Tulsa Dental Specialties or Satelec may damage the handpiece and even the tips themselves. • Always place a rubber dam to avoid inhaling or swallowing any parts.

Warning or Precaution

• The electrical supply to which the device is connected should comply with standards in force. (115v)

Additional information, explanation on operation and performance.

• The water supply system should satisfy the quality criteria required for the practice of dental treatment. It should be equipped with a supply cut-off system. • Do not cover the device or obstruct the air vents.

Do not dispose of as normal household waste; special disposal according to the Directive 2002/96/EEC of 27.01.2003 concerning waste of electrical/ electronic equipment

• Do not use the device if it appears to be damaged or defective. • Do not immerse in liquid or use outdoors. • Do not place the device near a heat source.

0459

CE marking Autoclavable at 134° C (sterilize before use)

• Make sure that the cords do not hinder the free passage of people. • Before unplugging the power cord, turnoff the water supply and switch the device off. • After use, turn-off the water supply.

Manufacturer’s batch code

• When unplugging the power cord, hold both the cord plug and the power socket in the wall.

No of items per package

• The device must not be used in the presence of explosive anaesthetic gases.

Most operation and maintenance problems result form insufficient attention being paid to basic safety precautions and not being able to foresee the possibilities of accidents. Problems and accidents are best avoided by foreseeing the possibility of danger and operating the unit in accordance with the manufacturer´s recommendations. Contraindication Use of the ProUltra Piezo Ultrasonic is contraindicated in patients and/or the operator with an active implant such as pacemaker, etc. Warnings None known.

• The device should be stored in its original packaging, in an appropriate place, where it will not cause any danger to people. • Do not carry out repairs or modifications to the device without prior authorization by the manufacturer. If any fault occurs, contact DENTSPLY Tulsa Dental Specialties rather than have it repaired by an unauthorized person. • The device 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. DENTSPLY Tulsa Dental Specialties will not be responsible for accidents, equipment damage, bodily injury or any other trouble which results from ignoring this prohibition. • In case of any doubt, contact DENTSPLY Tulsa Dental Specialties. • The device complies with the Electromagnetic compatibility standards (CEI 606011-2), however, make sure that any possible electromagnetic interference does not present any additional risk.

Adverse reactions

4. Step-by-step Instructions

None known.

4.1. Installation

2. Standard Components

Notes

Before set-up, check that all parts are present in the box (see Fig. 1):

• The ProUltra Piezo Ultrasonic should be connected to the electrical supply in accordance with current standards.

• Central unit with cords and foot pedal

• The water supply system should satisfy the quality criteria required for dental treatment.

• Handpiece • Tip wrench

In addition, it should be equipped with a water supply back flow prevention system.

• User manual Notes

1. Carefully remove the unit and the accessories from their packing and place them properly on a flat surface in the desired location. Check that the power adjustment knob is set to position OFF.

Notes

• None of the components are delivered disinfected or sterilized! • Prior to installation, check the device for damage. Report any damage sustained during shipment to your local supplier within 24 hours of receipt of the device.

3. Description

2. Contact your local Service Technician in order to connect the water tube to the water supply. 3. Connect the power plug to an electrical socket. 4. Place the foot pedal properly to make operation easy. 5. Connect the handpiece carefully by plugging it into the connector cord, aligning the electrical contacts (see Fig. 4 below).

Front panel (see Fig. 2) The power adjustment knob is used for switching the unit ON/OFF (ON is indicated by the green LED) and setting the ultrasonic power levels from 1 to 20 according to the recommended power range for each tip.

Notes

• See detailed directions for use of tips in section 4.3. “Operating the Unit”.

Warning

Fig. 4 Handpiece Connection

Neither rotate the handpiece nor twist the handpiece connector on its cord. 6. Place the handpiece with the head ahead on the handpiece holder (holder pivotable by 60°).

• Specific DFUs can be found in the Individual Tip Guide. • This device has been designed especially for endodontic root canal treatment, but can also be used for scaling, periodontic and other general dental applications. For details see section 4.3.2. “Other Applications.” Rear panel (see Fig. 3) There are four connections and one knob on the rear panel.

4.2. Before Operating the Unit 1. Sterilize the handpiece after disconnecting (see section 5 “Sterilization“). 2. Make sure there is no trace of moisture in the handpiece connection, if this is the case then wipe it and dry it with the airblower. Then reconnect the handpiece carefully to the handpiece connection without twisting and rotating.

– The water supply tube including a filter (9).

3. Sterilize the tips prior to first use (see section 5.1. “Sterilization“). Select the appropriate tip, and connect it by screwing it on with the supplied wrench. Tighten it moderately (see Fig. 5 below).

– The handpiece cord to connect the device to the handpiece (8).

4. Check that all connections are properly made.

– The power cord to connect the device to the electrical supply (11). – The foot pedal cord to operate the unit (10).

On the right hand side there is the water flow adjustment knob (7).

5. Prior to use, run a sufficient amount of water for several minutes to clear the line by pressing down the foot pedal with the power adjustment knob at the lowest level (1).

Fig. 5 Tip Tightening with Wrench

Warnings

Consider the following factors when selecting the endodontic tip:

• Correct tip vibration requires a tight fit, but without over-tightening as there is no stop point. Over-tightening the tip with force may damage tip and/or handpiece.

1. Choose the tip size in accordance to coronal access, root anatomy, procedural application and general visibility.

• Do not rotate the handpiece during installation of the tip when the handpiece is already connected to the cord.

2. Choose the appropriate minimum power setting for the tip that is being utilized.

• Do not disconnect the handpiece when power is switched on and the foot pedal is pressed down.

3. Increase the power gradually. Observe whether this setting allows safe procedure. If not efficient enough, increase the power gradually up to the maximum power setting for that tip, as needed to maximize clinical performance. 4. Use irrigation whenever the clinical situation is appropriate. (See Precautions)

4.3. Operating the Unit

General Notes

• The advanced technology of the device guarantees a stable power transfer to the tip to work at a constant amplitude. • The indicated power ranges are only relevant for operating the ProUltra Piezo Ultrasonic. These recommended ranges may not be appropriate for other ultrasonic piezo-generators.

Precautions regarding breakage • Do not switch quickly to the maximum level for each indication in order to avoid tip breakages. Too much vibration will damage the tip. • Never activate an ultrasonic instrument by pressing the foot pedal if it is still in the air and has not engaged the work site. • Even if used according to the instructions – within the recommended power range – the tip can break in some cases.

• The recommended settings are determined both by the clinician’s experience with ultrasonics and the power needed to safely complete the specific procedure.

4.3.2. Other Applications

• Some ultrasonic tips are equipped with a water port to run water through the water supply tube in order to cool during the treatment.

ProUltra Piezo Ultrasonic allows clinicians to carry out scaling and periodontic treatments with Satelec® tips which are compatible with the device.

4.3.1. Endodontic Applications

Notes

• Prior to the endodontic treatment place a rubber dam to avoid inhaling any foreign objects. • Sufficient optical magnification is recommended. Precautions • Dry operation without cooling can lead to overheating of the handpiece and might cause a necrosis. • To avoid this from happening, work intermittently, i.e. take breaks (5 mins operation/10 mins pause) when using the tip. For cooling, internal water line irrigation or external irrigation with a syringe is recommended. • For high-power applications, e.g. dislodging a metal post, it is mandatory to use water for cooling by adjusting the water spray knob. • Other medium-power applications, can be carefully carried out in dry procedure for a short time.

Notes

• For further information contact Satelec®.

• Refer to the Tip Book of Satelec® which gives detailed instructions for proper settings and applications of scaling and perio tip. • This warranty does not cover any damages caused by the application with Satelec® scaling and perio tips. Precautions • It is mandatory to always use the water spray during scaling and perio treatments. • Do not switch quickly to the maximum level for each indication in order to avoid tip breakages. Too much vibration will damage the tip. • Follow the instructions and precautions in the Tip Book from Satelec® or DENTSPLY Tulsa Dental Specialites.

4.4. After Operating the Unit

5.1.2. Tips

1. Turn-off the water supply

For instrument specifications see manufacturer’s recommendations.

2. Switch-off the device by turning the knob to OFF. 3. Remove tip and disconnect handpiece.

5. Sterilization and Replacement Parts

Notes

• Follow the maintenance and/or sterilization instructions before using the accessories supplied for the first time. • Avoid using cleaning agents and disinfectants containing flammable substances. If unavoidable, ensure that the product has evaporated and that there is no combustible product on the device and accessories before operation. • Consider concentration and contact time recommended by the manufacturer of the disinfectant.

• Use a disinfectant with tested effectiveness (e.g. DGHM certification or CE mark) or which is in compliance with any standard required by the national regulations. Handpiece (except handpiece cord), wrench and tips are sterilizable. 5.1. Autoclavable Components

Notes

• Autoclave in a standard autoclave (type B; compliant with standard EN 13060) with a cycle of 134°C for 18 minutes at a pressure of 2 bar minimum. • As not all autoclaves can reach 134°C and draw a pre-vacuum, please refer to your autoclave manufacturer for specific sterilization instructions. • Autoclave and dry temperatures must not exceed 135°C. • Thoroughly clean the components before autoclaving as described above. • If chemical solutions or foreign debris are not removed, autoclaving could damage or deform the components. • Autoclave handpiece and tips after each patient. • Do not sterilize in another way than in an autoclave. • During sterilization, metal parts of different types must not touch each other. Any contact will lead to the formation of electrolytic coupling causing localized deterioration. 5.2. Non-Autoclavable Components (Handpiece Cord and Control Unit) Wipe handpiece cord and control unit with an appropriate dental disinfectant solution.

5.1.1. Handpiece

1. Flush the water circuits of handpiece and tip at low power level for around 20-30 sec. by depressing the foot pedal. 2. Disconnect both the tip and the cord. 3. Disassemble the nozzle from the handpiece. 4. Clean the handpiece with an alcohol wipe before sterilization. 5. Put it in a sterilization pouch for autoclaving. 6. Autoclave at 134°C for 18 minutes. 7. After sterilization thoroughly dry the electrical contacts of the handpiece.

5.3. Replacement Parts • Replace the parts if necessary depending on degree of wear and duration of usage. • Reorder replacement parts from DENTSPLY Tulsa Dental Specialties.

6. Maintenance

6.3. Control Unit Maintenance

6.1. Handpiece Maintenance

1. Regularly inspect accessories and cords for insulation defects and replace if necessary.

• As a routine: after treatment with water flow, flush the water circuits of the handpiece and tip with water at a low power level for around 20- 30 seconds by pressing down the foot pedal. • In case of damage, excessive wear at least once a year: replace the watertight O-ring which is located in the rear part by using the fitting tool (for details see Fig. 6).

Note

Lubricate the water-tight O-ring with appropriate dental lubricant in order to prolong its efficacy and prevent internal leaks.

2. Regularly check whether the air vents of the control unit are clean to avoid overheating. 3. It is necessary to remove any traces of moisture in the handpiece connection; if yes dry it by wiping and airblowing. Warning Do not use the device if it appears to be defective. In case of any malfunction, contact the local supplier or directly DENTSPLY Tulsa Dental Specialties rather than have it repaired by an unauthorized person.

6.4. Water Filter Replacement and Maintenance Regularly clean and change the water filter if necessary.

Fig. 6 Handpiece Maintenance

6.2. Tip Maintenance Basically, shape and mass of a tip are the determining factors to obtain consistent performance of the ultrasonic generator. • The thinner the diameter of a tip, the less the tip should be re-used. • After a certain time of usage the shape of a tip will gradually be modified, i.e. the tip will become shorter. • Operation with a worn tip will lead to longer preparation time and may increase temperature in the cavity or root canal. It may also lead to tip breakage.

Follow the instructions below: 1. Turn-off the water supply and switch-off the device (OFF position), then unplug the power cord. 2. Unscrew the two parts of the filter using two open-ended 10 mm wrenches. 3. Remove the filter cartridge to replace or clean it under running water. 4. Proceed in the same manner for the seal. 5. Carry out the procedure in reverse to reassemble the components. 6. Check that the spray operates correctly and that there are no leaks.

1. Do not actively modify a tip by filing. 2. Regularly check a tip for visible wear with a loup or microscope. 3. Replace – the tip which is 3 to 4mm short after several operations, compared to the length of a new tip. – the tip which has apparently suffered an accidental impact (fall etc.). – the diamond coated tip as soon as it is worn. – tips that are bent to match canal curvature cannot be reused. – follow the use instructions received with authorized replacement tips.

Fig. 7 Disassembly of Filter

Warning Replace a worn or damaged filter cartridge.

Fig. 8 Reassembly of Filter

7. Troubleshooting

8. Technical / Performance Data

If the device does not operate correctly review the checklist below in order to exclude any user error before contacting your local supplier or DENTSPLY Tulsa Dental Specialties directly.

Model/Type

ProUltra Piezo Ultrasonic

Minimum frequency of vibrations

28 KHz

Problem

Possible cause

Solution

No operation

Defective power cord connection

Contact DENTSPLY Tulsa Dental Specialties for after sales service

Weights

Blown fuse

Contact DENTSPLY Tulsa Dental Specialties for after sales service

Control unit: 0.9 kg Handpiece: 52 gr

Dimensions (W x D x H)

Control unit: 11.2cm x 11.5cm x 12cm Foot pedal: 7cm x 9.5cm x 3cm

Maximum power

30 VA

Mains power supply

115 VAC 50 Hz / 60 Hz

Protection

Voltage of 100 VAC and 115 VAC: values of fuses 1 and 2 are 500 mAT (not accessible)

Device protection class

Protection Class II

Applied component type

Intermittent operation

5 mins. Operation / 10 mins. Pause

Water pressure at inlet

1 to 5 bar (14 to 72 PSI)

Water filter

60 μm

Turn half way to adjust water flow

0-90 ml/min

Defective water nose connection

Check water supply

No water pressure

Check pressure of mains

Clogged filter

Clean or replace filter

Defective solenoid valve

Contact DENTSPLY Tulsa Dental Specialties for after sales service

Obstructed tip or irrigation file

Remove obstruction for tips or irrigation files

Wrong tip selection

Check tip

Incorrect spray adjustment

Re-adjust water spray

Worn or deformed tip

Replace tip

Low vibration

Presence of fluid or moisture between handpiece and cord

Thoroughly dry electrical contacts with air

No ultrasonic output

Incorrect tip tightening

Re-tighten with wrench

Defective connector contact

Clean cord contacts

Cut wire in handpiece cord

Contact DENTSPLY Tulsa Dental Specialties for after sales service for cord replacement

Worn O-ring in handpiece

Replace the O-ring

No water spray

No water at tip but vibration present

Insufficient power

Water leak between handpiece and its base or at junction between

handpiece or cord

Ambient conditions Operating temperature

+10°C/50°F to +40°C/104°F at a maximum of 95% relative humidity without condensation

Storage temperature

-20°C/-4°F to +70°C/158°F at a maximum of 95% relative humidity without condensation

Note

The voltage is preset. The device is protected by fuses (unaccessible for user).

Note

Find additional information in the DFU of each ProUltra tip.

9. Disposal and Recycling

8. This warranty expressly excludes defects: – caused by damage during shipping.

As ProUltra Piezo Ultrasonic falls under the category of electric/ electronic equipment, the unit must be disposed of according to a specialized procedure for collection, pickup and recycling or destruction.

– which are not attributable to manufacturing defects but rather to normal wear caused by proper use of the device (and in particular, calcification and wear of the parts subject to wear).

As soon as the unit reaches the end of its life cycle, it is strongly recommended to contact the local dealer to obtain information on how to proceed.

10. Warranty Important – please read this limited warranty carefully to understand your rights and obligations. The manufacturer hereby certifies the correct construction of the product, use of topquality materials, performance of all the required testing, and product compliance to pertinent laws and regulations in force. The product is covered by warranty for a period of 12 months (excluding tips) beginning on the date of delivery to the end user as attested by the billing documents, containing the serial number of the unit, issued by the seller at the moment of purchase. The user has the right to request assistance under warranty only during the warranty period and only on condition that he notifies the manufacturer of the defect in writing within 2 months from the date the defect is noticed. 1. This warranty covers only replacement or repair of single components or pieces affected by manufacturing defects, excluding all expenses for visits by technical personnel and packing expenses. 2. This warranty does not extend to damage or breakdowns attributable to incorrect maintenance, incorrect power supply, negligence, and/or unskilled handling. The warranty does not cover trouble attributable to the user’s negligent failure to perform ordinary maintenance (see instruction manual). 3. This warranty does not provide for any compensation for direct or indirect damages of any kind to persons and/or things attributable to the inefficient operation of the unit. 4. This warranty shall automatically be void should the unit be repaired, modified, or in any manner tampered with by the user or by unauthorized third parties. 5. For repairs under warranty, the user must contact only the dealer or the manufacturer’s authorized service centres, or the manufacturer themselves. It is the responsibility of the user to ensure that the packing is in perfect condition or in any case suitable for safely shipping the unit. 6. Controversies regarding application of the warranty or the quality or condition of the devices supplied shall not grant the purchaser the faculty to suspend payment for the devices, in full or in part by installment. 7. The purchaser shall have no right to request compensation for device down-time.

– caused by atmospheric events such as (for example) lightning, by fires, and by humidity and in general by any other situation or event not directly attributable to the manufacturer. 9. This warranty does not include transportation costs. The warranty has validity only if accompanied by the billing document proving date of purchase of the product.

Note

The manufacturer has the right to modify the device and/or the user manual without prior notice.

APPENDIX

11.2. Electromagnetic Immunity

11. Electromagnetic Compatibility

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6KV contact

± 8KV air

Floors must be wood, concrete, cement or tiled. If floors are covered with synthetic material (carpet, etc.), the relative humidity must be at least 30%.

Electrical fast transients IEC 61000-4-4

± 2KV for power supply lines

Power quality should be that of a typical commercial or hospital environment (hospital, clinic).

Surges IEC 61000-4-5

± 1KV differential mode

± 2KV common mode

Power quality should be that of a typical commercial or hospital environment (hospital, clinic).

<5% UT (>95% dip in UT) for 0.5 cycles

40% UT (60% dip in UT) for 5 cycles

Notes

• The ProUltra Piezo Ultrasonic requires special precautions with regard to electromagnetic compatibility. • It must be set-up and prepared for use as described in section 4 “Operation”. • Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the ProUltra Piezo Ultrasonic.

• The recommended separation distances in this paragraph must therefore be complied with. • The ProUltra Piezo Ultrasonic must not be used near or on top of another device. If this cannot be avoided, it is necessary – before clinical use – to check the equipment for correct operation under the conditions of use. • The use of accessories other than those specified or sold by DENTSPLY Tulsa Dental Specialties or Satelec® as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the unit. 11.1. Electromagnetic Emissions

Table 2

Notes

• ProUltra Piezo Ultrasonic is intended for use in the electromagnetic environment specified in the following tables 1, 2 and 3 below.

Voltage dips, short interruptions and voltage variations IEC 61000-4-1

• The user and/or installer of the unit must ensure that it is used in such an environment.

70% UT (30% dip in UT) for 25 cycles

Table 1 Emission test RF emission CISPR 11

Electromagnetic environment - guidance Group 1

RF emission CISPR 11

Class B

Harmonic current emission IEC 61000-3-2

Class A

Voltage fluctuation and flicker IEC 61000-3-3

Complies

ProUltra Piezo Ultrasonic uses RF energy for internal operation Therefore, its radiofrequency emissions are very low and are not likely to cause any interference in nearby equipment. ProUltra Piezo Ultrasonic 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

<5% UT (>95% dip in UT) for 250 cycles Magnetic Field to 50Hz, IEC 61000-4-8

3A/m

70% UT (30% dip in UT) for 25 cycles

Power quality should be that of a typical commercial or hospital environment. If the use of the ProUltra Piezo Ultrasonic requires continued operation during a power cut, it is recommended that the product be powered from a separate power supply (UPS, etc.).

<5% UT (>95% dip in UT) for 250 cycles

3A/m

The intensity of the magnetic field must be equivalent to that of a commercial environment or typical of a hospital facility (hospital, clinic).

11.3. Electromagnetic Immunity / Mobile Radiofrequency Equipment Table 3 Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Portable and mobile radiofrequency communications devices must not be used near the ProUltra Piezo Ultrasonic (including its cables) at a distance less than that recommended and calculated according to the frequency and power of the emitter. Conducted disturbance, radiofrequency fields. IEC 61000-4-6

3 V/m

Radiated radiofrequency electromagnetic field. IEC 61000-4-3

3 V/m

150 KHz to 80 MHz

Recommended separation distance: d = 1.2

3 V/m

80 MHz to 2.5 GHz

d = 1,2 80 MHz to 800 MHz d = 2,3 800 MHz to 2.5 GHz Where P is the maximum power rating of the emitter in watts (W) according to the manufacturer’s specifications and d is the recommended minimum separation distance in meters (m).

Interference may occur near equipment marked with this symbol.

Note

At 80 MHz and 800 MHz, the higher frequency range applies.

– In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be less than 3 V/m. 11.4. Recommended Separation Distances The ProUltra Piezo Ultrasonic is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled.

The electromagnetic field strengths of fixed radiofrequency emitters, as determined by an electromagnetic environment measurement (a), must be less than the compliance level in each frequency range (b).

– The electromagnetic field strengths of fixed radiofrequency emitters, such as base stations for mobile telephones (cellular/cordless), mobile radios, amateur radios, AM/FM radio broadcasts and TV broadcasts cannot be determined exactly by theory. To assess the electromagnetic environment due to fixed radiofrequency emitters, an electromagnetic environment measurement must be made. If the measured radiofrequency field strength in the immediate environment where the product is used exceeds the compliance level specified above, the performance of the product must be tested to verify whether it conforms to the specifications. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product.

The user and/or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment (emitters) and the ProUltra Piezo Ultrasonic according to the maximum output power of the equipment, as recommended in the table below. Table 4 Rated max. power of the emitter (W)

Separation distance in meters (m) according to emitter frequency 150 KHz to 80 MHz d = 1,2

80 MHz to 800 MHz d = 1,2

800 MHz to 2,5 GHz d = 2,3

0.01

0.12 m

0.23 m

0.1

0.38 m

0.73 m

1.2 m

2.3 m

3.8 m

7.3 m

100

12 m

23 m

For emitters rated at max. power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the emitter, where P is the max. power rating of the emitter in watts (W) according the manufacturer.

Note

At 80 MHz and 800 MHz, the higher frequency range applies.

Note

These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and persons.

Note

These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and persons.

11.5. Cable Lengths Both handpiece cord and power cord are 2m length. Table 5 Cables and accessories

Maximum length

Complies with

RF emission, CISPR 1 – Class B/Group 1 Harmonic current emission: IEC 61000-3-2 Voltage fluctuation: IEC 61000-3-3 Handpiece cord Control foot pedal Power cord

Immunity to electrostatic discharge: IEC 61000-4-2 <3m

Immunity to electrical fast transients/bursts: IEC 61000-4-4 Immunity to surges: IEC 61000-4-5 Immunity to voltage dips, short interruptions and voltage variations: IEC 61000-4-11 Immunity to conducted disturbances induced by radiofrequency fields: IEC 61000-4-6 Immunity to radiated radiofrequency electromagnetic fields: IEC 61000-4-3 Immunity to magnetic field at 50 Hz: IEC 61000-4-8

MADE IN FRANCE

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Handpiece with Wrench

ProUltra Piezo Ultrasonic Instructions for Use