Piezotome 2 Users Manual V3

I - INTRODUCTION Congratulations! You have just taken possession of your PIEZOTOME™ 2. Designed by SATELEC®, the PIEZOTOME 2 is a multifunction device intended for: • surgical procedures (osteotomy, osteoplasty, periodontal and implant surgery) with its PIEZOTOME 2 or PIEZOTOME 2 LED handpiece. • mechanical ultrasonic treatment (prophylaxis, periodontics, endodontics) with its NEWTRON® or NEWTRON LED handpiece (according to option). In order to get the most out of this hightechnology device and ensure it has a long working life, please read this manual carefully before using or maintaining it. Points preceded by the symbol should be given particular attention.

II - WARNINGS CAUTION: United States Federal Law restricts the use of this device solely to qualified, trained and competent dental health practitioners or under their supervision. The tips designed for PIEZOTOME 2 and IMPLANT CENTER 2 are not compatible with PIEZOTOME and IMPLANT CENTER, and vice versa. To reduce the risk of accidents, the precautions stipulated below must be taken:

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Device users: - Use of the PIEZOTOME 2 is restricted solely to qualified, trained and competent dental health practitioners in the normal context of their work. - If you have received this device by error, please contact the supplier so that it can be removed. Interactions: - PIEZOTOME 2 must not be used if the patient and/or the operator has a cardiac stimulator (pacemaker) or any other active implant (e.g. a cochlear implant). - The device complies with applicable electromagnetic compatibility standards. The user should nevertheless ensure that any potential electromagnetic interference does not cause an additional risk (presence of radiofrequency emitters, electronic devices, etc.). - The device is not designed to withstand shocks delivered by an electric defibrillator. - Do not attempt to connect to the PIEZOTOME 2 connectors any other accessories than those supplied by SATELEC. Electrical connection: - Your PIEZOTOME 2 must be connected to the electric power supply by a certified dental installation technician. - Warning: To avoid any risk of electric shock, this device must be connected to an electrical power supply with a protective ground. - The electric supply to which the device is connected must comply with the standards in force in your country. - If loss of electrical power during use is likely to generate an unacceptable risk, the device must be connected to a suitable power source (e.g. UPS).

Using the device: - Do not use the device if it appears to be damaged or faulty. - Turn the device OFF before unplugging the power cord. - To unplug the power cord, grip the cord plug and hold the wall socket. - Never use any other irrigation solution containers than those intended for suspension from the supplied brackets. - The device must only be used with bottles or bags of physiological saline or sterile water. - The capacity of the irrigation solution containers used must not exceed one litre. - When the device is not to be used for a long period of time, unplug the device from the electric supply. - Do not exert excessive force on the screen. - Do not move the device during use. Environment: - Do not cover the device or obstruct the ventilation vents. - Do not immerse the device in liquid, and do not use it outdoors. - Do not tilt the device at an angle greater than 5°. - Do not place the device near a heat source. - Make sure that the cords are not in a traffic path. - The device must be stored in its original packaging in an appropriate and safe place. - The device is not designed for use in the presence of anaesthetic gases or any other flammable gas. - Do not expose the device to water vapour, or splashes. - Any condensation inside an electrical device may be dangerous. - If the device has to be moved from a cool place to a hot place, it must be allowed to warm up to the new room temperature before being used. 6

- The device is not designed to work near ionizing radiation. - Do not insert metal objects into the device (risk of electric shock, short-circuit or emission of hazardous substances). Maintenance: - Before and after each use, your device must be disinfected with products recommended by SATELEC. - Before each procedure, it is essential to make sure that the accessories to be used have been cleaned, disinfected and sterilized. Accessories: - The device has been designed and developed with its accessories in order to ensure maximum safety and performance. - Use of accessories from other manufacturers is a potential hazard for you, your patients or your device. Repair: - Warning: Do not repair or modify the device without prior authorization from SATELEC. - Warning: If the device is modified or repaired, specific checks and tests must be performed to ensure that the device can still be used safely. - In the case of a fault, contact the supplier of your device. Do not use unauthorized repairers, who might make your device dangerous for you and your patients. If in any doubt, contact an approved dealer or our customer support department: - www.acteongroup.com - E-mail: [email protected].

III - DESCRIPTION 3. 1 PHYSICAL DESCRIPTION

Identification of information display areas common to all modes (Fig. 3) - 2: Irrigation flow rate value - 9: Operating fault indicator

PIEZOTOME 2 has the following components: - a control unit (Fig. 1), - a PIEZOTOME 2 LED handpiece with its cord (Fig. 12) (according to option), - a NEWTRON LED handpiece (Fig. 1-3) (according to option), - a NEWTRON scaler cord (Fig. 1-4) (according to option), - a grounded power cord (Fig. 1-5), - an LCD (Liquid Crystal Display) touch screen (Fig. 1-6), - two cord connectors for the two ultrasonic functions (Fig. 1-7 and 8), - two peristaltic pump housings (Fig. 1-9), - two brackets for irrigation solution (Fig. 1-10), - a multifunction footswitch (Fig. 8).

Identification of key areas common to all modes that also display information (Fig. 3) - 1: Flush/prime - 3: Irrigation ON/OFF - 8: Save, store data - 10: Select footswitch mode - 11: Handpiece light ON/OFF - 12: Select mode (according to connected handpiece type)

Located at the back of the unit are: - 1 power cord socket with ground pin (Fig. 2-1), - 1 footswitch connector (Fig. 2-2), - 1 fan (Fig. 2-3), - 2 bracket holders (Fig. 2-4), - 1 power switch (Fig. 2-5).

Identification of key areas that also display information (Fig. 4) - 14: Select program: D1, D2, D3, D4

Key areas and displays specific to the selected mode PIEZOTOME mode: Identification of information display areas (Fig. 4) - 13: Selected program power level

NEWTRON mode: Identification of information display areas (Fig. 5) - 15: Selected program power level

3. 2 TECHNICAL DESCRIPTION a) LCD touch screen The LCD touch screen (Fig. 3) is used to define the settings of your PIEZOTOME 2. The PIEZOTOME 2 settings are adjusted by applying reasonable pressure to the screen keys.

Identification of key areas that also display information (Fig. 5) - 16: Select program: Soft, Medium, High, Boost Startup page: Identification of key areas (Fig.6) - 17: Enter TOOLBOX mode

Identification of key areas common to all modes (Fig. 3): - 4: Reduce the irrigation flow rate - 5: Increase the irrigation flow rate - 6: Reduce value - 7: Increase value 7

TOOLBOX:

Identification of information display areas (Fig. 7) - 19: Audio volume symbol - 20: Screen brightness symbol - 21: Light off time-out symbol - 25: Relative audio volume value - 26: Relative brightness level value - 27: Selected time-out value - 28: Software version Identification of key areas (Fig. 7) - 18: Reset factory configuration - 22: Reduce value - 23: Increase value - 24: Validate the configuration b) Control unit back panel The power receptacle (Fig. 2-1) with its grounding pin is used to connect the PIEZOTOME 2 to the power supply using a plug-in power cord. The footswitch connector (Fig. 2-2) is used to connect the PIEZOTOME 2 to the multifunction control footswitch. The fan (Fig. 2-3) protected by a metal grille, keeps the PIEZOTOME 2 at its optimum performance level. The bracket holders (Fig. 2-4) are used to install the brackets. The power switch (Fig. 2-5) is used to switch the device ON or OFF. c) Control unit sides The pump housings (Fig. 1-9) are designed to accommodate SATELEC irrigation line cassettes. The irrigation cassettes are installed by lifting the pump covers and inserting the cassettes horizontally into the cassette housings.

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d) Front panel The two connectors are designed to accept the connector of the NEWTRON / NEWTRON LED cord or the connector of the PIEZOTOME 2 / PIEZOTOME 2 LED handpiece cord. e) Control footswitch The access to a large number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of cross-contamination. Once the various settings have been adjusted, the user has no further need to touch the keypad. Depending on the mode, the control footswitch buttons have different functions. PIEZOTOME mode: Footswitch button definition (Fig. 8) - 1: Ultrasonics control (ON/OFF or progressive) - 2: Flush/prime - 3: Change program (D1 to D4) - 4: Irrigation ON/OFF - 5: Select active handpiece NEWTRON mode: Footswitch button definition (Fig. 8) - 1: Ultrasonics control (ON/OFF or progressive) - 2: Flush/prime - 3: Change program (Soft to Boost) - 4: Irrigation ON/OFF - 5: Select active handpiece f) Technical characteristics Manufacturer: SATELEC Device name: PIEZOTOME 2 Electrical power supply: - Voltage: 100 VAC to 230 VAC - Frequency: 50 Hz/60 Hz - Rated power: 150 VA at 230 VAC

PIEZOTOME function Operation: Intermittent service: 10 min. ON / 5 min. OFF Output characteristics: No-load voltage: 250 volts (nominal value without handpiece) Min. ultrasonic frequency: 28 kHz Irrigation flow rate: 10 to 120 ml/min. (nominal value) Adjustment in 10 ml/min. steps (nominal value) Flush flow rate: 120 ml/min. (nominal value) NEWTRON function Operation: Intermittent service: 10 min. ON / 5 min. OFF Output characteristics: No-load voltage: 150 volts (nominal value without handpiece) Min. ultrasonic frequency: 28 kHz Irrigation flow rate: 10 to 40 ml/min. (nominal value) Adjustment in 1 ml/min. steps (nominal value) Flush flow rate: 120 ml/min. (nominal value) Protection Electrical equipment class: Class 1 Electrical safety class: Type BF in PIEZOTOME mode Type BF in NEWTRON mode

Depth: 339.9 mm Weight: 5 kg without accessories Footswitch: Width: 311 mm Depth: 209 mm Height: 181 mm Weight: approximately 3.5 kg LCD screen: Height: 86 mm Width: 115 mm Scaler handpiece cord: 2 000 mm (2 900 mm optional) PIEZOTOME 2 handpiece cord: 2 000 mm (2 900 mm optional) Temperatures Operation: +10°C to +40°C Storage: -20°C to +70°C Humidity Operation: 30% to 75% Storage: 10% to 100% including condensation Atmospheric pressure Between 500 hPa and 1060 hPa

Safety devices Safety shut off if internal malfunction 2 fuses (power receptacle): 5 mm x 20 mm / 2 AT for 100 VAC to 230 VAC 1 internal fuse not accessible to the user reference F1: 5 mm x 20 mm – 10 AT / 250 VAC Overall dimensions Control unit: Width: 472.9 mm Height: 149.5 mm Height with bracket: 471.1 mm 9

IV - INSTALLATION / FIRST USE 4. 1 UNPACKING THE DEVICE Upon receipt of the device, check for any damage caused in transit. Contact your supplier if necessary. 4. 2 RECOMMENDATIONS Have your PIEZOTOME 2 connected to the power electricity supply by a certified dental installation technician. The electrical connection of the PIEZOTOME 2 must comply with the applicable standards in your country.

- Position the footswitch so that it is easily accessible for your feet. - Insert the brackets into the bracket holders (Fig. 2-4). - Connect the N EWTRON scaler cord or the PIEZOTOME 2 handpiece cord to the connector (Fig. 1-7 and/or 1-8) (according to option). - Connect the NEWTRON handpiece to the scaler cord (delivered according to option). - Check that the device is close enough to the work area to be used without pulling on the cords. If it is not, move the device closer. - Place the NEWTRON or PIEZOTOME 2 handpiece on the handpiece support. - Suspend the bottles or bags of physiological saline or sterile water from the brackets. - Adjust the position of your device to suit your angle of view. 4. 4 FIRST USE

Warning: To avoid any risk of electric shock, this device must be connected to an electrical power supply with a protective ground.

Before using the PIEZOTOME 2 for the first time, all the equipment must be given routine maintenance and/or sterilized according to the procedures defined in chapter 11.

4. 3 INSTALLATION Important: Do not place the PIEZOTOME 2 close to or on top of another device. Do not place the power cord and the footswitch cord in a wire cover or in a cable gland. - Place the control unit in position on a fixed surface, horizontal or with a slope of no more than 5°. - Check that the power switch (Fig. 2-5) is in position O (OFF). - Connect the power cord to the device. - Connect the power cord to a power socket with a ground pin. - Connect the control footswitch to the footswitch connector (Fig. 2-2). 10

V - IRRIGATION SOLUTION PIEZOTOME 2 is not designed to administer drugs. It must be used only with bottles or bags of physiological saline or sterile water with an individual capacity not exceeding one litre.

VI - IRRIGATION LINES PIEZOTOME 2 must be used exclusively with SATELEC irrigation lines.

VII - ADJUSTMENTS / SETTINGS / MODES / INTERFACE

b) Flow rate adjustment The irrigation flow rate is adjusted using buttons and

(Fig. 3-4 and 5).

Each time the corresponding button is pressed, the flow rate is adjusted. Press and hold buttons 7. 1 STARTUP Important: After stopping the device, wait four seconds before restarting it. By default, when the device is switched on, the right-hand handpiece is selected. If no handpiece is connected, the device selects the right side in PIEZOTOME mode. 7. 2 SETTINGS The settings are saved when each program is configured and are retrieved whenever that program is selected.

and (Fig. 3-4 and 5) to scroll the flow rate values. The adjusted value is displayed on the LCD screen (Fig. 3-2) and stored in the current program. The flow rate can be adjusted while the device is being used. c) Irrigation ON/OFF The irrigation is switched ON or OFF by pressing button (Fig. 8-4).

(Fig. 3-3) or the footswitch button

When irrigation is selected, the symbol is highlighted. When irrigation is not selected, the symbol

7. 3 IRRIGATION FUNCTION is darkened. a) Flush / prime The flush / prime function is available on the LCD screen and on the footswitch.

7. 4 LIGHT FUNCTION The light function is displayed on the LCD screen.

Press button (Fig. 3-1) or the footswitch button (Fig. 8-2) to switch on the flush / prime function. The flush / prime function stays on as long as the button is pressed. The flush can be switched on while the device is being used.

Pressing button (Fig. 3-11) switches the light function available for the NEWTRON and PIEZOTOME functions ON or OFF. The light function has a default light-off time-out of nine seconds. Switching off the light function becomes effective when the time-out has elapsed. If necessary, you can lengthen the time-out (refer to 7.7).

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7. 5 PIEZOTOME FUNCTION

The power level of the program concerned is shown

Important: The PIEZOTOME function settings can be customized by the user. The PIEZOTOME function settings can be adjusted when no PIEZOTOME 2 handpiece is connected to the device.

as a number and a bar-graph (Fig. 4-13). Modify the footswitch type if necessary by

The program giving the highest power is D1.

Important: In progressive mode, for programs D1 to D3, the delivered power ranges between power level 1 of program D3 and the configuration defined by the user (program and power level). In progressive mode, the power delivered by program D4 ranges only between levels 1 and 5, according to the value defined by the user.

Program Very powerful

D1

Powerful

D2

Medium

D3

Low

D4

Main functions

Osteotomy, osteoplasty

pressing button ON/OFF

(Fig. 3-10) to toggle between

and progressive

.

If necessary, select handpiece light function Soft tissue detachment ON/OFF by pressing button (Fig. 3-11). Confirm the new settings by pressing button

Select the PIEZOTOME function by pressing button (Fig. 3-12) or by pressing the footswitch button (Fig. 8-5). On the LCD screen, the PIEZOTOME tab must be highlighted. Select the program to be used by pressing button , , or (Fig. 4-14) or using the footswitch button (Fig. 8-3); the selected program is highlighted on the LCD screen. Adjust the programs and the power level according to the tip data sheet recommendations. If necessary, modify the irrigation function (flow rate value, etc.) (refer to 7.3). If necessary, modify the program power level (1 to 5) using buttons 12

(Fig. 3-6) and

(Fig. 3-7).

(Fig. 3-8). The saving of the various settings is confirmed by an audible signal and a visual signal (button flashing). Repeat this sequence if necessary in order to adjust all the programs. Caution: The tips designed for PIEZOTOME 2 and IMPLANT CENTER 2 are not compatible with PIEZOTOME and IMPLANT CENTER, and vice versa. 7. 6 NEWTRON FUNCTION Important: A scaler cord and its NEWTRON handpiece must be connected to the device in order to be able to configure the various settings. The NEWTRON function settings can be customized by the user.

Select the NEWTRON function by pressing button

7. 7 TOOLBOX

(Fig. 3-12) or by pressing the footswitch button (Fig. 8-5). On the LCD screen, the NEWTRON tab must be highlighted. Select the program for which settings are to be

Important: PIEZOTOME 2 has a TOOLBOX function used to make various adjustments, including brightness, light off time-out, audio volume and factory configuration reset.

adjusted by pressing buttons

To access the TOOLBOX function, switch OFF the device, wait four seconds, switch the device ON

,

,

or (Fig. 5-16) or by pressing the footswitch button (Fig. 8-3). Adjust the power level according to the TIPBOOK recommendations.

again, then press button welcome screen (Fig. 6).

(Fig. 6-17) on the

a) Audio volume adjustment If necessary, modify the program power level (1 to Adjust the audio volume value 10) using buttons (Fig. 3-6) and (Fig. 3-7). The power level of the program concerned is shown as a number and a bar-graph (Fig. 5-15). Modify the footswitch type if necessary by

(Fig. 7-19)

using buttons and (Fig. 7-22 and 23). The audio volume is adjustable from 0% to 100%. The relative value of the audio volume is displayed (Fig. 7-25).

pressing button (Fig. 3-10) to toggle between ON/OFF and progressive.

b) Screen brightness adjustment

If necessary, select handpiece light function

Adjust the brightness value

ON/OFF by pressing button

buttons and (Fig. 7-22 and 23). The brightness is adjustable from 30% to 100%.

(Fig. 3-11).

Confirm the new settings by pressing button (Fig. 3-8). The saving of the various settings is confirmed by an audible signal and a visual signal (flashing button). Repeat this sequence if necessary in order to adjust all the programs.

(Fig. 7-20) using

The brightness level setting is displayed (Fig. 7-26). c) Light off time-out adjustment Adjust the time-out length value by pressing buttons

and

(Fig. 7-21)

(Fig. 7-22 and 23).

The length of the adjustable time-out (from nine seconds to 18 seconds) is displayed (Fig. 7-27).

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d) Storing the settings

NEWTRON mode:

To store the modified settings, press button (Fig. 7-24). The screen shown in Fig. 6 reappears.

Program

Power Irrigation Main functions

Green

Soft

P=5

e) Factory configuration reset Yellow

Medium

P=5

Press button (Fig. 7-18) to restore the factory configuration settings.

Blue

High

P=5

The factory configurations for the PIEZOTOME and

Orange

Boost

P=5

NEWTRON functions are effective when button (Fig. 7-24) is pressed. The screen shown in Fig. 6 reappears. f) Software version The version of the software is displayed at the bottom of the screen (Fig. 7-28). PIEZOTOME 2 is configured in the factory with the following settings: PIEZOTOME mode:

15 ml/min. 15 ml/min. 15 ml/min. 15 ml/min.

Periodontics Endodontics Scaling Loosening

VIII - SAFETY PIEZOTOME 2 has a system that detects malfunctions of the device. If an internal operation error occurs, symbol 1 (Chap XVII - Symbol) is displayed in the error zone (Fig. 3-9) and the device beeps four times. It is recommended that the device be switched OFF (Fig. 2-5) and switched back ON again.

IX - USING THE DEVICE

Program Power Irrigation Main functions Very powerful

D1

3

Powerful

D2

3

Medium

D3

3

Low

D4

3

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60 ml/min. 60 ml/min. 60 ml/min. 60 ml/min.

Osteotomy, osteoplasty

Soft tissue detachment

Important: - Do not disconnect the handpiece cords when the device is switched ON and the footswitch is pressed. - Do not disconnect the NEWTRON handpiece when the device is switched ON and the footswitch is pressed. - Do not screw or unscrew tips when the handpieces are on. - All accessories must be cleaned, disinfected and sterilized before use. - For your safety and that of your patient, PIEZOTOME 2 must not be used with accessories other than those supplied or recommended by SATELEC.

- Check the integrity of the device and its accessories before and after each use in order to detect any problem. - If necessary, do not use the device and replace any faulty component. The PIEZOTOME 2 is prepared for use as follows: - Make sure that the device is connected correctly and properly insulated. - Switch the power switch (Fig. 2-5) to position I (ON). - Suspend the bottles or bags of physiological saline or sterile water from the brackets. - Raise the irrigation pump covers. - Insert the irrigation line cassettes horizontally into their housings. - Close the covers. - Insert the irrigation line perforating pins into the bottles or pouches of physiological saline and open the cap on the pins. - Make any necessary setting adjustments (irrigation flow rate, power mode, program, etc.) (refer to chapter 7). Note: This sequence must be completed under conditions of controlled asepsis for the safety of your patients. An operating assistant may be needed. Note: The previously-used display settings are saved automatically when switching between modes. PIEZOTOME function - Connect the PIEZOTOME 2 handpiece cord to one of the connectors of the device (Fig. 1-7 and 8). - Screw the selected tip onto the handpiece using a tip wrench (according to the recommendations of the clinical booklets). - Fasten the irrigation line to the cord using line clips. - Connect the end of the irrigation line to the PIEZOTOME 2 handpiece.

- Prime the irrigation circuit by pressing the flush/prime button on the screen (Fig. 3-1) or the multifunction footswitch (Fig. 8-2). - When the irrigation solution reaches the end of the tip, release the footswitch. - Use the PIEZOTOME 2 in accordance with good dental practice. NEWTRON function - Check that there are no traces of moisture on the NEWTRON handpiece or the scaler cord connections. Remove any moisture by wiping and by drying with the multifunction syringe fed with medical-quality filtered air. - Connect the scaler cord to one of the connectors of the device (Fig. 1-7 and 8). - Align the electrical contacts of the NEWTRON handpiece and the scaler cord, then plug the handpiece into the cord. - Screw the selected tip onto the handpiece using a tip wrench (according to the TIPBOOK recommendations). - Fasten the irrigation line to the cord using line clips. - Connect the end of the irrigation line to the scaler cord. - Prime the irrigation circuit by pressing the flush/prime button on the screen (Fig. 3-1) or the multifunction footswitch (Fig. 8-2). - When the irrigation solution reaches the end of the tip, release the footswitch. - Use the PIEZOTOME 2 in accordance with good dental practice.

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X - SHUTTING DOWN THE DEVICE Upon completion of the dental procedure: - Remove the bottles or bags of physiological saline or sterile water from the brackets. - Remove the irrigation line perforating pins from the bottles or bags. - Immerse the irrigation line perforating pins in a vessel containing distilled water. - Rinse each irrigation line alternately, along with the handpiece, by running the flush function until the vessel and the irrigation lines are completely empty. - Remove the irrigation line clips. - Disconnect the single-use irrigation lines from the handpieces and dispose of them in a safety container for soiled medical items. - Disconnect the PIEZOTOME 2 handpiece or the NEWTRON handpiece and the scaler cord. - Switch the device OFF (O).

To maintain the sterility or asepsis of the accessories (cords, handpieces, etc.), store them in sealed bags or containers suitable for medical practice. The maintenance and/or sterilization instructions below must be applied before each use of the device. Avoid using cleaning and disinfection agents containing flammable substances. If this is not possible, make sure that all the agent has evaporated and that there is no combustible matter on the device or its accessories before it is switched on. Sterilized items must be allowed to dry and cool to room temperature before they are reused. Before sterilization, check that your autoclave is clean and that the water used is of adequate quality.

XI - ROUTINE MAINTENANCE/ After each sterilization cycle, remove the items from the autoclave immediately in order STERILIZATION to minimize the risk of metal corrosion. 11. 1 IRRIGATION LINE MAINTENANCE Important: The device must be switched OFF during cleaning and disinfection procedures. The only irrigation lines that can be sterilized are those identified as sterilizable. During sterilization, items made of different metals must not come into contact. Any contact would establish galvanic couples and cause localized damage. To avoid this happening, place the items in individual sterilizable bags or in a sterilization box. 16

Sterile irrigation line The irrigation lines supplied by SATELEC are disposable and must always be discarded after use. Re-use of an irrigation line may result in contamination of your patients and expose you to de facto liability. Do not attempt to resterilize the single-use irrigation lines. Do not attempt to modify the irrigation lines. Sterilizable irrigation line Refer to the user's manual delivered with the equipment.

11. 2 DEVICE MAINTENANCE Important: Never use an abrasive cleaning agent on the device. Do not use sprays or liquids to clean and disinfect the PIEZOTOME 2 control unit. The device, the brackets and the multifunction footswitch are not sterilizable. The PIEZOTOME 2 control unit, the control footswitch and the bracket must always be cleaned and disinfected after each procedure, using alcohol, disinfectant agents or disinfectant wipes for dental practices, such as SEPTOL™ wipes. Regular monitoring of the PIEZOTOME 2 unit is necessary in order to detect any problem. It is important to keep the control unit ventilation vents clean in order to avoid abnormal heating. 11. 3 SCALER CORD MAINTENANCE Important: Never use an abrasive cleaning agent on the cords. The cords must not be immersed or disinfected using agents containing acetone, chlorine or bleach. The cords must not be cleaned in an ultrasonic bath. a) Cleaning and disinfection The cords must always be cleaned, disinfected and sterilized after each procedure, using alcohol, disinfectant agents or disinfectant wipes for dental practices, such as SEPTOL™ wipes. Disconnect the NEWTRON handpiece from its cord before cleaning, disinfection and sterilization.

b) Sterilization The cords can be sterilized in an autoclave under the following conditions: - Autoclave: Class B - Sterilization temperature: 134°C at 2 Bar - Time at sterilization temperature: 18 minutes CAUTION: Not all autoclaves can reach 134°C. Not all autoclaves draw a pre-vacuum. Please refer to your autoclave manufacturer for specific sterilization instructions. 11. 4 ULTRASONIC HANDPIECE MAINTENANCE After each use, the handpiece irrigation circuit must be rinsed with distilled or demineralized water for 20 to 30 seconds. Cleaning and disinfection: The handpieces must always be cleaned, disinfected and sterilized after each procedure, using alcohol, disinfectant agents or disinfectant wipes for dental practices, such as SEPTOL™ wipes. For handpiece sterilization, refer to the manual for each product. 11. 5 TIP MAINTENANCE a) Lifetime Tip shape and weight are the determining characteristics for obtaining maximal efficiency of the ultrasonic generator. Careful monitoring of these two characteristics by the user will ensure that optimal performance of the device is maintained. Consequently, you are strongly advised not to alter the structure of the tips by filing or twisting them or modifying them in any other way. Similarly, through normal wear, tip aging leads to alteration of its characteristics. Always replace a 17

tip that has been damaged by wear or by accidental impact (dropped, bent, etc.). Use the TIPCARD to check scaler tip wear. Replace routinely-used tips at least once a year. b) Pre-disinfection / chemical cleaning To be carried out immediately after treatment, wearing thick gloves. Immerse in an ultrasonic bath (enzymatic, quaternary ammonium base detergent / disinfectant solution), carefully respecting the concentration and contact time recommended by the manufacturer of the solution. Use a solution that bears the EC marking or that is in compliance with any standard required by the national regulations. Rinse under running water for at least 30 seconds. c) Mechanical / chemical cleaning To be carried out immediately after predisinfection/chemical cleaning, wearing thick gloves. Scrub the products in a new bath of enzymatic, quaternary ammonium base detergent / disinfectant solution, for at least 30 seconds, and in any case until all remaining traces of contamination have been removed. Rinse again under running water for at least 30 seconds. d) Drying Dry with a clean, non-woven single-use cloth, so as to remove any traces of liquid. Pack in singleuse sterilization pouches or bags in compliance with the specifications defined in standard EN ISO 11607-1 or in any equivalent standard required by the national regulations.

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e) Sterilization The tips must be sterilized individually in an autoclave, according to the following parameters: - autoclave: type B, compliant with standard EN 13060 - sterilization temperature: 134°C - sterilization stabilization time: 18 minutes - pressure: 2 Bars min. f) Storage Store the sterilized products in a dry place protected from dust. Before re-use, if the integrity of the packaging is not certain, repackage then re-sterilize in accordance with the defined protocol. If contamination is visible inside the bag, destroy the product. g) Disposal of the product Dispose of the product in receptacles for waste materials of healthcare activities involving infectious risks. CAUTION: Not all autoclaves can reach 134°C. Not all autoclaves draw a pre-vacuum. Please refer to your autoclave manufacturer for specific sterilization instructions.

XII - MONITORING / MAINTENANCE Important: In the case of a fault, you are advised to contact the supplier of your device. Do not use unauthorized repairers, who might make your device dangerous for you and your patients. 12. 1 MONITORING Regular monitoring of the device and its accessories is necessary in order to detect any insulation fault or damage. Replace them if necessary. It is important to keep the control unit ventilation vents clean in order to avoid abnormal heating.

- Replace the old fuses with fuses of the same type and rating. - Push the fuse drawer back into its housing until it clicks to indicate the correct position. - Plug the power cord into the receptacle (Fig. 2-1). Plug the power cord into the electrical supply. Note: The device also has an internal fuse not accessible to the user. Contact SATELEC after-sales service (see Chapter 2 - Repairs). All the information necessary for the repair of faulty components is made available by SATELEC to the technical personnel of the SATELECapproved dealer network who carry out the work. 12. 4 OPERATION FAULTS Refer to the table below:

12. 2 PREVENTIVE AND CORRECTIVE MAINTENANCE PIEZOTOME 2 does not need any preventive maintenance other than monitoring of the accessories and routine cleaning/disinfection. 12. 3 FUSE REPLACEMENT PIEZOTOME 2 is protected by two fuses located in the power receptacle (Fig. 2-1). The replacement procedure is as follows: - Switch the device OFF (position O). - Unplug the power cord from the electricity supply. - Unplug the power cord from the receptacle (Fig. 2-1). Insert the tip of a flat screwdriver into the notch above the fuse drawer to release it. - Remove the old fuses.

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Fault

Possible cause Power cord not plugged in properly.

Power switch in position O (OFF). Device does not operate No power voltage. (LCD screen off) Power receptacle fuse(s) blown. Internal fuse blown Device does not operate Transmission fault. (LCD screen on)

Inadequate spray

No ultrasonic function

No light

Call an electrician. Replace the power receptacle fuses. Return to SATELEC after-sales.

Irrigation off. Irrigation line clogged.

Change irrigation line.

Incorrect irrigation flow rate adjustment. Adjust the irrigation flow rate. Tip worn or distorted.

Power fault weak tip vibration

Place the power switch in position I (ON).

Switch the device OFF then ON again. Return to SATELEC after-sales. Replace the bag or bottle of irrigation solution. Press the irrigation ON/OFF button.

Irrigation solution bag or bottle empty. No spray

Remedy Check the electric socket. Return to SATELEC after-sales.

Replace the tip.

Refer to the TIPBOOK or clinical booklet for the necessary information. Incorrect use: incorrect angle of attack or Refer to the TIPBOOK or clinical booklet for inadequate pressure on the tooth. the necessary information. Liquid or moisture present between Dry the electrical contacts thoroughly. handpiece and cord. Incorrect power adjustment.

Incorrect tip tightening.

Retighten the tip with the wrench.

Faulty connector contact.

Clean the connector contacts.

Handpiece cord wire cut.

Return to SATELEC after-sales to replace the cord.

Handpiece light ring absent.

Install the light ring.

Faulty light ring.

Replace the light ring.

Faulty light ring connector contacts.

Clean the light ring connector contacts.

Light ring the wrong way around.

Position the light ring according to the foolproofing stud.

Faulty handpiece and/or cord connector Clean the handpiece and/or cord connector contacts. contacts. Other.

Contact your installer-fitter.

Leak between the NEWTRON handpiece and the handpiece cord

Worn handpiece 1.15x1 seal

Replace the seal (kit F12304).

Liquid leak in the irrigation pump

Broken tube in the irrigation line cassette.

Replace the irrigation line.

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XIII - ELECTROMAGNETIC COMPATIBILITY Important: The power cord, the ultrasonic handpiece cords and the multifunction footswitch cord must be kept away from each other. PIEZOTOME 2 requires special precautions to be taken with regard to electromagnetic compatibility. It must be installed and prepared for use as described in chapter 4. Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the PIEZOTOME 2. The recommended separation distances in this paragraph must therefore be complied with. PIEZOTOME 2 must not be used near or on top of another device. If this cannot be avoided, its operation under the conditions of use must be checked beforehand. The use of accessories other than those specified or sold by SATELEC as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the PIEZOTOME 2. 13. 1 ELECTROMAGNETIC EMISSIONS PIEZOTOME 2 is intended for use in the electromagnetic environment specified in the table below. The user and/or installer must ensure that the PIEZOTOME 2 is used in such an environment.

Emission test

Compliance

Electromagnetic environment - guidance

RF emission - CISPR 11

Group 1

PIEZOTOME 2 uses RF energy for internal operation. Therefore, its radiofrequency emissions are very low and are not likely to cause any interference in nearby equipment.

RF emission - CISPR 11

Class A

Harmonic current emission IEC 61000-3-2

Class A

Voltage fluctuation and flicker IEC 61000-3-3

Complies

PIEZOTOME 2 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.

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13. 2 ELECTROMAGNETIC IMMUNITY PIEZOTOME 2 is intended for use in the electromagnetic environment specified in the table below. The user and/or installer must ensure that the device is used in such an electromagnetic environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2.

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV 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.

± 2 kV for power supply lines

± 2 kV for power supply lines

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

Surges IEC 61000-4-5.

± 1 kV differential mode ± 2 kV common mode

± 1 kV differential mode ± 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% UT (>95% dip in UT) for 0.5 cycles. Voltage dips, short interruptions and voltage variations IEC 61000-4-11.

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 250 cycles

<5% UT (>95% dip in UT) for 0.5 cycles. 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the use of the PIEZOTOME 2 requires continued operation during power mains interruption, it is recommended that the product be powered from a separate power supply (UPS, etc.).

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

13. 3 ELECTROMAGNETIC IMMUNITY / RADIOFREQUENCY MOBILE EQUIPMENT The PIEZOTOME 2 is intended for use in the electromagnetic environment specified in the table below. The user and/or installer must ensure that the device is used in such an electromagnetic environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile radiofrequency communications devices must not be used near the PIEZOTOME 2 (including its cables) at a distance less than that recommended and calculated according to the frequency and power of the emitter. Conducted Recommended separation distance: disturbance, 3 V/m 3 V/m radiofrequency fields. 150 kHz to 80 MHz d = 1.2 IEC61000-4-6 Radiated radiofrequency electromagnetic field. IEC61000-4-3

d = 1.2 3 V/m 80 MHz to 2.5 GHz

80MHz to 800MHz.

d = 2.3 800MHz to 2.5GHz. 3 V/m 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). 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). Interference may occur near equipment marked with the symbol below:

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Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and persons. (a): The electromagnetic field strengths of fixed radiofrequency emitters, such as base stations for mobile telephones (cellular / cordless), mobile radios, amateur radio, 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 specification. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the product. (b): In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be less than 3 V/m. 13. 4 RECOMMENDED SEPARATION DISTANCES PIEZOTOME 2 is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled. The PIEZOTOME 2 user and/or installer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment emitters and the PIEZOTOME 2, according to the maximum output power of the equipment, as recommended in the table below. Separation distance in metres (m) according to emitter frequency Rated max. power of the emitter (W)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

0.01

d = 1.2 0.12 m

d = 1.2 0.12 m

d = 2.3 0.23 m

0.1

0.38 m

0.38 m

0.73 m

1

1.2 m

1.2 m

2.3 m

10

3.8 m

3.8 m

7.3 m

100 12 m 12 m 23 m For emitters rated at max. power not listed above, the recommended separation distance d in meteres (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 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and persons.

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