Newtron P5XS B.LED User Manual V3 Nov 2013

4.21 Filling the tank 4.22 Pump 4.23 Cleaning the irrigation system 5 Cleaning, disinfecting and sterilizing 5.1 Cleaning and disinfection of the medical device 5.2 Cleaning and disinfecting accessories 5.3 Diamond coated tips 6 Monitoring and maintenance of the medical device 7 Maintenance 7.1 Identifying incorrect operation 7.1.1 No operation 7.1.2 No spray 7.1.3 The power is not as expected 7.1.4 Ultrasounds not working 7.1.5 Water leakage 7.2 Corrective Maintenance 7.2.1 Replacing the fuses 7.2.2 Replacing the irrigation cassette 8 Technical specifications for the medical device 8.1 Identification 8.2 Control unit 8.3 Ultrasonic generator 8.4 Length of cords 8.5 Irrigation 8.6 Control pedal 8.7 Environmental characteristics 8.8 Environmental restrictions 8.9 Main performance characteristics 9 Regulations and standards 9.1 Official Texts 9.2 Medical class of the device 9.3 Standardised Symbols 9.4 Manufacturer identification 9.5 Branch addresses 9.6 Disposal and recycling 10 Index

13 13 13 15 15 16 16 17 19 19 19 19 19 20 20 20 20 21 25 25 25 25 25 25 26 26 26 26 27 27 27 28 29 30 32 33

Foreword The medical device SATELEC® that you are about to install and use in your practice is a medical device designed for professional use. It comprises the chosen tool with which you will provide treatment within the context of your work. To ensure optimum safety for yourself and your patients, comfort in your daily practice and to benefit fully from the technology of your medical device, please read the documentation provided carefully. If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected. Please refer to the general instructions relating to the comprehensive range of dental ultrasonic generators by SATELEC® for information about the following: l documentation format; l the documentation archiving period; l warnings concerning user population; l the treatment area; l the medical device usage interactions, contraindications and prohibitions; l electromagnetic compatibility; l disposal and recycling of the medical device; l manufacturer responsibility. Please refer to the accessory cleaning, disinfection and sterilization protocols and the handpiece predisinfection, cleaning and sterilisation protocols for information about the following: l preparation of parts for sterilization; l detailed manual and automatic protocols; l information concerning the sterilization; l recommendations for the inspection of parts.

1 Documentation This document contains the following information: l indications for use; l description of the medical device; l installation of the medical device; l use of the medical device; l preparation for cleaning and disinfection of the medical device; l monitoring and general maintenance of the medical device; l maintenance to be performed by the user.

1.1 Associated documentation This document must be used in association with the following documents: Document title

References

Cleaning, disinfection and sterilization protocols for Wrenches SATELEC®

J81009

Cleaning, disinfection and sterilization protocols for Tips SATELEC®

J02009

Cleaning, disinfection and sterilization protocols for Handpieces SATELEC®

J12919

General instructions relating to the complete range of SATELEC® dental ultrasonic generators

J00019

Method for consulting electronic user instructions

J00000

Quick Clean Newtron ® P5XS B.LED

J62101

Quick Start Newtron ® P5XS B.LED

J62100

User Manual for Newtron ® P5XS B.LED

J62159

Software User Manual Newtron ® P5XS B.LED

J62111

1.2 Electronic documentation The user instructions for your device are provided in electronic format and not in printed format. However, you can request a free printed copy of the user instructions within 7 days via our website, by telephone or in writing. The electronic user instructions are available in PDF format (Portable Document Format) and you will need to have a PDF file read software installed to read the instructions. The device user instructions can be consulted at the following address:

www.satelec.com/documents

It is important for you to have read and understood the content of the user instructions relating to the use of your device and its accessories prior to use. We recommend that you visit the website regularly to consult and/or to download the latest version of your device's user instructions.

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 5/37

2 Required information 2.1 Indication for use This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.

2.2 Operating principle An electrical signal emitted by the medical device is supplied to the dental ultrasonic handpiece. This is connected to the medical device via a cord. The handpiece comprises a piezoelectric ceramic transducer, which transforms the electrical signal into ultrasonic vibrations. Mechanical vibrations are transmitted to a tip or a dental file attached to the end of the ultrasonic handpiece.

2.3 Date of inclusion of EC marking 2013

2.4 Latest document update 11/2013

2.5 Repairing or modifying the device Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous for you and your patients. Do not repair or modify the medical device without seeking the prior permission of SATELEC® . If the device is modified or repaired, specific checks and tests must be carried out to ensure that the device is still safe to use. In the event of doubt, contact an approved dealer or the SATELEC® customer service team :

www.acteongroup.com [email protected] SATELEC® at the request of technical personnel working for the network of dealers approved by SATELEC® , provides all information required to repair the faulty parts on which they may perform repairs.

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 7/37

2.6 Warranty

The screws marked A, B and C must not under any circumstances be unscrewed by the user as this may void the warranty for the medical device.

2.7 Accessory usage conditions Accessories and must be cleaned, disinfected and sterilized prior to use.

Page 8/37 - User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C

3 Removal from packaging, installation, connections 3.1 Unpacking your medical device 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. If you have any questions or requirements, contact your supplier. The Newtron® P5XS B.LED includes the following items: l a Newtron® P5XS B.LED unit with non-detachable pedal cord, a non-detachable SLIM cord, a 300 or 500ml tank and a SLIM handpiece support; l a Newtron® SLIM handpiece, a Quick Start [J12900] and a Quick Clean [J12930]; l tips and wrenches depending on selected options; l a Quick Start Newtron® P5XS B.LED [J62100]; l a Quick Clean Newtron® P5XS B.LED [J62101].

3.2 Positioning the medical device Place the control unit in the position that is suitable for your activity. Check that the cords do not hinder the movement or free circulation of anyone. The medical device must be placed on a secure and flat surface or a surface with a maximum slope of 5 degrees. Fix your medical device using the attachments provided to ensure that the device cannot be removed without the use of a tool. Adjust the position of your medical device to correspond to your angle of vision and the characteristics of your workstation, e.g. lighting or distance between the user and the medical device. Ensure that you can access your medical device quickly. Do not install your medical device near or on another device.

3.3 Installing cords Check that the cords do not hinder the movement or free circulation of anyone. Never rotate the handpiece connector on its cord as this can damage your medical device. Never wrap the handpiece cord around the medical device. Make sure that it is not possible to wheel over or walk on the different cords. The cord attached to its must be easily accessible. Make sure that the cord is slack during use. Do not put the medical device cords in a cable cover or a cable tray.

3.4 Connecting the medical device to the electrical network Set the medical device to OFF position O and check that the mains voltage is compatible with that indicated on the medical device or its mains adapter. Next, connect the cord to the wall socket in compliance with the standards in force in the country of use. 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 device's operation. The medical devices equipped with a protective earth must be connected to a supply network equipped with a protective earth.

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 9/37

Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or cable tray.

3.5 Plugging the medical device to the electrical network 1. Set the medical device's mains switch to stop position O; 2. connect the mains cord to the control unit mains connector; 3. connect the mains cord to the electrical fixture wall socket.

3.6 Installing the control pedal The control pedal must be positioned near the feet of the operator and must be readily accessible.

Page 10/37 - User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C

4 Description of the medical device 4.1 Control unit The control unit incorporates technology Newtron® patented by SATELEC® . The patented technology Newtron® controls the tips by Cruise Control® , an automatic system for setting the frequency and power in real time. This ensures that Satelec® tip vibration is gentle, regular and controlled.

4.2 Power configuration button To ensure a quality treatment, you will need to use the tips at the power and irrigation flow settings recommended by SATELEC® . The ultrasound power configuration button ensures: l Configuration of the operating power: 1 to 20. The configuration button has 20 graduations. Rotating the button causes the color of the retro-lightning to change. l Green: 1 to 6: very low to low power, used mainly for periodontics. l Yellow: 6 to 11: medium power, used mainly for endodontics. l Blue: 11 to 16: high power, used mainly for scale removal. l Orange: 16 to 20: very high power, used mainly for implant loosening. The ultrasound power configuration button can be removed by the user to facilitate the cleaning and disinfection of the control unit. The button cannot be sterilised. The removal of the button inhibits the activation of ultrasounds. The top surface of the control unit lights up white and the control pedal can be pressed to activate the purge function. The purge function can be stopped at any time by pressing the control pedal again.

4.2.1 Remote configuration via Bluetooth (depending on option) The Newtron® P5XS B.LED, depending on the option, allows you to use a tablet or a smartphone to remotely pre-configure the power and irrigation settings. Refer to the P5XS application instructions [J62111] for more information. Only the Newtron® P5XS B.LED with Bluetooth option is compatible with remote configuration.

4.3 Adjusting ultrasound power Adjust the ultrasound power using the ultrasound power configuration button. The ultrasound power must be adjusted in accordance with the tip used and the required treatment. The operating power of the tips must be selected in compliance with the Satelec tips color coding system (CCS tips). Details of these indications are given in the adjustment table available at the address www.satelec.com/documents and on the treatment sheets.

4.4 SLIM handpiece Only handpieces with SLIM connector SATELEC® can be connected to the medical device. There is a handpiece with SLIM connector without LED, and a handpiece with SLIM connector B.LED with white LED. Refer to the Newtron® handpiece user manual [J12921] for more information.

4.5 Attach a tip or a file A tip or a file vibrates correctly when it is perfectly tightened without being forced beyond its stop point. Tighten it moderately using the wrench provided to ensure optimum ultrasound operation. Over-tightening of the tip or file can result in breakage of the tip, file or . To prevent self-locking of the tip or the file, the latter must be removed after each use.

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 11/37

4.6 Connecting and disconnecting accessories during use Do not connect/disconnect the cord(s) or the handpiece when the medical device is switched on and your foot is on the pedal. Do not tighten or loosen the tips when the handpiece is activated.

4.7 Connecting the handpiece Check for the absence of signs of humidity at the connections, and eliminate them if necessary (wipe and blow using a multipurpose syringe). Lubricate the irrigation system seal located behind the with dental instrument lubricant such as ClearView™ Dental Handpiece Lubricant manufactured by Dental Air Solutions to extend its effectiveness and prevent leaks. Connect the to the sleeve, by aligning the indexing points and by avoiding rotation movement. Install the on the support.

4.8 Handpiece support The support holds the handpiece or the handpiece connector. The handpiece support can be fixed to the front face or the right side face of the medical device. To change the position of this support, unscrew the two screws located under the support, position the support over the two holes located on the right side face and insert and tighten the two fastening screws. The two silicone supports can be removed by sliding them along the metal rod.

4.9 The cord The SLIM cord is only compatible with handpieces SATELEC® with SLIM connector. The SLIM cord ensures irrigation circulation and electrical connection between the medical device and the .

4.10 Light indicator The light indicator is designed to provide information about the status of the device. When the light indicator is illuminated, the medical device is on and ready to use. The indicator's colour corresponds to the power level.

4.11 Irrigation flow configuration button The irrigation flow configuration button stops the irrigation function at the minimum stop marked by "O" and sets the irrigation flow from mark "I" to "+": The irrigation flow configuration button can be removed to clean the medical device. The button cannot be sterilised. The purge function is activated by pressing the pedal for 4 minutes; it can be stopped by pressing the pedal again.

The pump operates at its maximum flow rate

in purge position.

4.12 Adjusting the irrigation Adjust the irrigation flow using the irrigation flow configuration button. This adjustment depends on the tip and the treatment. As work habits, feedback and professional training differ from one professional to another, the user must make sure that the irrigation flow is perfectly adapted to the treatment to be carried out to avoid burning the treatment area.

Page 12/37 - User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C

4.13 Initiating irrigation The medical device must be set to minimum power depending on the required irrigation flow rate. Press the pedal until a spray appears.

4.14 Air inlets Air inlets ensure correct ventilation of the control unit. Leave them uncovered to allow air to circulate.

4.15 Control pedal The ON/OFF type pedal is used by the practitioner to operate the medical device. Pressing the pedal automatically activates the handpiece ultrasounds, and the irrigation function if it is not in 0 position. The control pedal equipped with its cord cannot be disconnected. Its weight and antislip pad ensure good stability. The light function remains active for approx. 9 seconds after the pedal is released.

4.16 Activating ultrasounds using the pedal To activate the ultrasounds on your medical device, press the control pedal.

4.17 Mains Connector The mains connector with its earthing pin is used to connect the device to the electrical network via a disconnectable mains cord.

4.18 Switch The mains switch is used to switch on (position I) or to stop (position O) the medical device.

4.19 Fuse recess The recess holds two mains fuses designed to protect the medical device in the event of overvoltage or an internal fault.

4.20 Irrigation solution tank The medical device is equipped with a tank designed to hold 300ml or 500ml of irrigation solution depending on the option chosen. The maximum capacity is shown by the MAX mark on the tank. The irrigation solution tank is fitted with a cover. Neither the tank nor the cover can be sterilised.

4.21 Filling the tank Remove the tank from the medical device by pulling it upwards. Fill the irrigation solution tank up to the MAX mark.

4.22 Pump The medical device is fitted with a peristaltic pump. This pump must be replaced yearly by the practitioner using the F62202 kit or by the After-Sales Department SATELEC® .

4.23 Cleaning the irrigation system After installation and before first use, at the end of the day and following a period of prolonged non-use of the medical device, it is important to clean the irrigation system. 1. fill the tank with hypochlorite diluted at less than 3%; 2. position the irrigation flow configuration button on purge; 3. operate the irrigation spray for two minutes to rinse the medical device's internal water system; 4. refill the tank with demineralised or distilled water, or even drinking water; 5. rinse the system for two minutes.

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 13/37

When the irrigation system has been cleaned, perform the following operations: 1. disconnect the handpiece and refer to handpiece predisinfection, cleaning and sterilisation protocols SATELEC® [J12919]; 2. clean and disinfect the medical device as indicated in the chapter Cleaning and disinfection of the medical device page 15 3. follow the instructions for accessory cleaning, disinfection and sterilization protocols SATELEC® [J81009] and [J02009].

Page 14/37 - User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C

5 Cleaning, disinfecting and sterilizing The instructions relating to accessory cleaning, disinfection and sterilization protocols provided by SATELEC® have been approved for each medical device and accessory. The applicable guides are listed in chapter Associated documentation page 5 They can be downloaded at the following address:

www.satelec.com/documents In all cases, the local regulations in force relating to the accessory cleaning, disinfection and sterilization protocols take precedence over the information provided by SATELEC® .

5.1 Cleaning and disinfection of the medical device The medical device must be in OFF or O stop position during cleaning and disinfecting procedures. Refer to the instructions detailed in the chapter Cleaning the irrigation system page 13 Avoid using cleaning and disinfection products that contain flammable agents. Otherwise, ensure that the product has completely evaporated from or that there is not fuel left on the medical device and its accessories before switching it on. Do not use abrasive product to clean the medical device. Never apply sprays directly to the medical device to clean it. Always spray the product onto a wipe, then clean the medical device. The medical device control unit, handpiece cord and control pedal must be cleaned and disinfected daily. The wipes Unowipes manufactured by Medicart International Ltd may be used to clean and sterilise the medical device.

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 15/37

To prepare for cleaning, remove the various parts of Newtron® P5XS B.LED as shown here.

5.2 Cleaning and disinfecting accessories Refer to the accessory cleaning, disinfection and sterilization protocols listed in the chapter Associated documentation page 5.

5.3 Diamond coated tips Diamond coated tips are for single use only. The diamond coated inserts cannot be reprocessed since they cannot be cleaned properly. Bone and soil residues might remain adhered to the diamon coating even after cleaning and sterilization and enter into the oral cavity of another patient.

Page 16/37 - User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C

6 Monitoring and maintenance of the medical device Before and after each use, check that the device and its accessories are not faulty in any way. This is necessary to detect any isolation fault or damage. If necessary, replace damaged parts. Monitor the cleanliness of the air inlets on the control unit to prevent any heating.

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 17/37

7 Maintenance The only preventive maintenance the medical device requires is: l checking of accessories; l everyday cleaning, disinfection and sterilisation procedures; l cleaning.

7.1 Identifying incorrect operation In the event of incorrect operation, refer to the tables below to quickly identify and repair the non-complex parts of the medical device. If the incorrect operation is not described in the tables below, please contact your supplier or the After-Sales team at SATELEC® . Do not use the medical device if it appears to be damaged or faulty. Isolate the medical device and make sure that it cannot be used.

7.1.1 No operation Symptoms: the indicator light on the medical device is off and the medical device is not working. Possible causes

Solutions

No electrical current

Contact your electrician

Internal fuse not working

Return to After-Sales team SATELEC®

Mains switch in position O

Set the mains switch to position I

Faulty connection between the mains cord and the mains connector

Connect the mains cord to the mains connector

Faulty connection between the mains cord and the electrical wall socket

Connect the mains cord to the electrical wall socket

Mains fuses in the mains connector not working

Replace the mains fuses with fuses of the same type and rating

The medical device also has an internal fuse (ref. F1 on the printed circuit board) that cannot be accessed by the user.

7.1.2 No spray Symptoms: There is no water spray at the tip. Possible causes

Solutions

Flow configuration button on minimum

Adjust the flow configuration button

Tip or file blocked

Unblock the tip or file

Incorrect choice of tip

Check the tip

Inadequate amount of spray

Adjust the spray

No irrigation solution in the tank

Fill the irrigation solution tank

7.1.3 The power is not as expected Symptoms: the tip does not vibrate at the expected frequency, the treatment is not progressing as normal and is taking longer or at is at a standstill. Possible causes Worn or distorted tip Incorrect use: incorrect approach angle or inadequate pressure on the tooth Presence of liquid or humidity between the handpiece and cord

Solutions Replace the tip Refer to the configuration table available at

www.satelec.com/documents Thoroughly dry the electrical contacts

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 19/37

7.1.4 Ultrasounds not working Symptoms: the tip does not vibrate, vibration cannot be heard. Possible causes

Solutions

Tip loose

Tighten the tip using the wrench

Faulty connector contact

Clean the cord contacts

Handpiece cord wire(s) cut

Return to After-Sales Department SATELEC® to replace the cord

7.1.5 Water leakage Symptoms: Water is leaking from one of the following places: l between the base of the and its cord ; l under the tank; l under the medical device. Possible causes

Solutions

Wear of 1.15 mm x1 mm seal

Replace the seal using F12304 kit. Refer to the instructions in document J12921

Wear of the tank seal

Contact the After-Sales Department SATELEC® to replace the tank

Worn irrigation cassette

Replace the irrigation cassette using kit F62202 as detailed in the chapter Replacing the

irrigation cassette page 21

7.2 Corrective Maintenance In the event of faulty operation, the following corrective maintenance actions may be performed by the user.

7.2.1 Replacing the fuses The medical device is protected by two fuses in the mains connector. To replace the fuses, perform the following operations: l stop the medical device (position O); l disconnect the mains cord from the electrical network; l disconnect the mains cord from the mains connector; l insert the tip of a flathead screwdriver into the notch on top of the fuse holder to release it; l remove the used fuses;

l l

replace the used fuses with fuses of the same type and same rating; place the fuse holder in its recess by pushing it until you hear a click that confirms it is in the correct position;

Page 20/37 - User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C

l l

connect the mains cord to the connector; connect the mains cord to the electrical network; The medical device also has an internal fuse (Ref. FU1 on the printed circuit board) that cannot be accessed by the user.

7.2.2 Replacing the irrigation cassette

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 21/37

8 Technical specifications for the medical device 8.1 Identification Manufacturer

SATELEC®

Name of the medical device

N EWTRON® P5XS B.LED

8.2 Control unit Width (in mm)

260

Height (in mm)

110, 145 with 300 ml tank, 182 with 500 ml tank

Depth (in mm)

155

Weight (in g)

1 674 with pedal, SLIM cord and 300 ml tank; 1 712 with pedal, and 500 ml tank

Ingress protection rating

IPX0

8.3 Ultrasonic generator Supply voltage

100 VAC - 240 VAC

Power consumption

60 VA

Voltage supplied to handpiece

150 VAC

Output frequency

Minimum 28 kHz

Power setting range

1 to 20

Operating mode

Intermittent: 10 minutes ON / 5 minutes OFF

Type of leakage currents

BF

Electrical rating

1

Internal fuse not accessible to the user

Ref: FU1 / 1.5 AT - 125 V - SMD - Breaking capacity: 50 A

Fuse (mains connector)

2 x 1 AT / 230 VAC fuses – 5mm x 20mm - Breaking capacity: 35 A

8.4 Length of cords Scaler handpiece cord (in mm)

>2 040

Control pedal cord (in mm)

>2 000

8.5 Irrigation Tank capacity (in ml)

300 or 500

Nominal water output flow at the end of the handpiece (in ml/min)

5 to 40

Nominal water output flow at purge (in ml/min)

80

User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C - Page 25/37

8.6 Control pedal Width (in mm)

70

Height (in mm)

30

Depth (in mm)

95

Weight (in g)

150

Ingress protection rating: IPX1

8.7 Environmental characteristics Operating temperature

+10°C to +30°C

Storage temperature

-0°C to +60°C

Operating humidity

30 % to 75 %

Storage humidity

10 % to 70 %, including condensation

Atmospheric pressure

Between 800 hPa and 1060 hPa

Altitude

Less than or equal to 2000 metres

8.8 Environmental restrictions Usage premises

Can be used at all medical premises. The medical device must not be used in an operating theatre, or outside.

Use in gas-filled atmosphere

The medical device is not designed for use in a type AP or APG gas-filled atmosphere or in the presence of anaesthetic gases.

Immersion

The must not be immersed.

8.9 Main performance characteristics Ultrasonic vibrations of the tip or file fitted to the end of the conventional dental ultrasonic handpiece. l Vibration frequency ≥ 28 kHz. l Tip amplitude ≤ 200 µm.

Page 26/37 - User Manual • Newtron® P5XS B.LED • J62159 • V3 • (13) • 11/2013 • NBADUS030C