Acteon Piezotome Cube User manual

User Manual
Piezotome Cube

This document is an English translation of the original French version.
Reference J50100 version V4 and drawing number NO37FR010D

Contents
1 Documentation 3
1.1 Associated documentation 3
1.2 Electronic documentation 3
2 Required information 5
2.1 Intended use 5
2.2 Indication for use 5
2.3 Operating principle 5
2.4 Using accessories not supplied by the manufacturer 5
2.5 Connecting and disconnecting accessories during use 5
2.6 Repairing or modifying the medical device 5
2.7 Warranty 6
2.8 Latest document update 6
2.9 Date of first CE marking 6
3 Unpacking the medical device 7
4 Connect the medical device 9
4.1 Connecting the medical device to the electrical network 9
4.2 Connecting the medical device to the electrical network 9
5 Installing the medical device 11
5.1 Install cords 11
5.2 Installing the control pedal 11
5.3 Connecting the handpiece 11
5.4 Installing an irrigation line 11
5.5 Attaching a tip 12
6 Dispensing a treatment 15
6.1 Accessory usage conditions 15
6.2 Preparation for use 15
6.3 Switching off the medical device 15
7 Medical device description 17
7.1 Front view of the medical device 17
7.2 View of the right-hand side of the medical device 17
7.3 Rear view of the medical device 18
7.4 Overview of the interface 18
7.5 Control unit 19
7.6 Handpiece 19
7.7 Screen of the medical device 20
7.8 Setting the power 20
7.9 Setting the irrigation flow 20
7.9.1 Activating the purge function/starting irrigation 20
7.10 Air inlets 20
7.11 Control pedal 20
7.12 Mains Connector 21
7.13 Switch 21
7.14 Fuse recess 21
7.15 Irrigation lines 21
8 Disinfection and sterilising 23
8.1 Clean and disinfect the medical device 23
8.2 Cleaning, disinfecting and sterilising accessories 24
9 Monitoring and routine maintenance 25
9.1 Cleaning the irrigation system 25
9.2 Corrective Maintenance 25
9.2.1 Replacing the fuses 25

10 Identifying incorrect operation 27
10.1 Not working 27
10.2 No spray 27
10.3 The power is not as expected 27
10.4 Ultrasounds not working 27
10.5 Water leakage 28
10.6 Disturbance of settings defined by the practitioner 28
11 Technical specifications of the medical device 29
11.1 Identification 29
11.2 Generator 29
11.3 Length of cords 29
11.4 Irrigation 29
11.5 Footswitch 29
11.6 Environmental characteristics 30
11.7 Environmental restrictions 30
11.8 Main performance characteristics 30
12 Regulations and standards 31
12.1 Applicable standards and regulations 31
12.2 Medical class of the device 31
12.3 Symbols 31
12.4 Quick Start and Quick Clean symbols 33
12.5 Manufacturer identification 34
12.6 Branch addresses 35
12.7 Disposal and recycling 36
13 Index 37

1 Documentation
This document contains the following information:
lIndications for use
lIntended use
lMedical device description
lInstallation of the medical device
lMedical device use
lPreparation for cleaning and disinfection of the medical device
lMonitoring and general maintenance of the medical device
lMaintenance to be performed by the user
1.1 Associated documentation
This document must be used in association with the following documents:
Document title References
General instructions relating to the complete range of dental ultrasonic generators J00051
Cleaning, disinfection and sterilisation instructions for keys J81001
Cleaning, disinfection and sterilisation instructions for tips J02001
Cleaning, disinfection and sterilisation instructions for the Handpiece-piezotome cord assembly J12801
Consulting electronic user instructions J00007
Piezotome Cube Quick Start guide J50150
Piezotome Cube Quick Clean guide J50151
Piezotome Cube User Manual J50101
Dental surgery ultrasonic generator power settings table J58010
Installation flyer for handpiece support J50152
Cube LED handpiece user manual J28821
The Quick Start and Quick Clean documents are summaries created for your approval.The only binding
instructions are the user manuals and regulatory documentation associated with the medical device.
1.2 Electronic documentation
The user instructions for your device are available in electronic format on the specified website and not in printed
format. If the website is unavailable, try again later. You can also request a free printed copy of the user instructions
within seven days via our website, by telephone or in writing.
The electronic user instructions are available in PDF format (Portable Document Format). You will need to have a PDF
file reader installed to read the electronic user instructions. 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.
Never use your device without first reading the user instructions.
The device user instructions can be consulted at the following addresses:www.ultradent.com and www.satelec.com.
When you receive your device, you are asked to print and/or to download all documents or sections of documents that
you may need to refer to in the event of an emergency, if you are unable to connect to the internet or if your electronic
display tool is not working (computer, tablet, etc.). We recommend that you visit the website regularly to consult and to
download the latest version of your device's user instructions. Users are asked to keep documentation close at hand
for reference when necessary.
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All paper or electronic documentation relating to your medical device must be kept for the device’s entire service life.
Keep the original documentation for your medical device and its accessories for future reference. When loaning out or
selling the medical device, the documentation must be provided with it.
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2 Required information
2.1 Intended use
The intended use of the Piezotome Cube SATELEC is to provide utilities and to act as a base for various dental
instruments and accessories.This device is intended to be used by qualified professional dentists.
2.2 Indication for use
The Piezotome Cube is a command unit used in combination with the following items.
An intraoral surgery ultrasonic handpiece and an intraoral surgery tip. This combination is intended for use in intraoral
surgery procedures, including osteotomy osteoplasty, syndesmotomy, membrane detachment and bone expansion.
2.3 Operating principle
An electrical signal emitted by the medical device is supplied to the 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 an intraoral surgery dental tip attached to the end of the ultrasonic
handpiece.
The medical device must be used with a Cube LED handpiece. Refer to the Cube LED [J28821] handpiece user manual
for further information.
2.4 Using accessories not supplied by the manufacturer
The handpiece is designed to operate with SATELEC, a company of Acteon group tips. The use of other makes of tips
will damage the handpiece and break the tips.
2.5 Connecting and disconnecting accessories during use
Do not tighten or loosen the tips when the handpiece is activated.
2.6 Repairing or modifying the medical 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 device without seeking the prior permission of SATELEC, a company of Acteon group.
If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical device is
still safe to use.
In the event of doubt, contact an approved dealer or the SATELEC, a company of Acteon group Customer Service team:
www.acteongroup.com
[email protected]
SATELEC, a company of Acteon group, at the request of technical personnel working for the network of
approved dealers, will provide any information required to repair defective parts on which they may perform
repairs.
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2.7 Warranty
The screws marked A to N must never be unscrewed by the user. Unscrewing these screws will void the warranty for
the medical device.
2.8 Latest document update
03/2018
2.9 Date of first CE marking
2017
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3 Unpacking the 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 Piezotome Cube features the items listed in the document J50154.The article codes of the items for restocking are
indicated in the same document.
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4 Connect the medical device
4.1 Connecting the medical device to the electrical network
Have your medical device connected to the mains power by an approved dental installation technician.
Switch the medical device 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 the 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.
Medical devices equipped with a protective earth must be connected to a supply network equipped with a protective
earth.
Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or cable
tray.
If when using the medical device, a power outage can create an unacceptable risk, the user and the installer
must ensure that the medical device is connected to an appropriate power source such as an uninterruptable
power supply.
4.2 Connecting the medical device to the electrical network
1. Set the medical device's mains switch to "O" OFF position.
2. Connect the mains cord to the control unit's mains connector.
3. Connect the power lead to the mains socket.
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5 Installing the medical device
Place the medical device in the position that is suitable for your activity.
The medical device must be placed on a secure and flat surface or a surface with a maximum slope of five degrees.
Check that the cords do not hinder the movement or free circulation of anyone.
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 your medical device is readily accessible. The disconnecting devices - the switch and the power plug - must
be easy to locate and access.
Do not install your medical device near or on another device.
5.1 Install cords
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 handpiece must be easily accessible. Make sure that the cord is slack during use.
5.2 Installing the control pedal
Connect the footswitch cord to the back of the medical device.
The control pedal must be positioned near the feet of the operator and must be readily accessible.
5.3 Connecting the handpiece
Connect the cord and handpiece assembly to the connector on the control unit panel.
5.4 Installing an irrigation line
1. Remove the irrigation line from its sterilisation bag.
2. Remove the clips from their bag.
3. Open the cassette holder on the right side of the medical device.
4. Insert the cassette and close the holder.
5. Connect the end of the irrigation line, the long infusion line, to the handpiece
6. Working your hands along the handpiece cord, attach the irrigation line to the handpiece cord using the clips.
Any excess irrigation line will be at the medical device unit and will not hamper use of the handpiece.
7. On the short infusion line side, pierce the irrigation solution bag with the perforator.
8. When the medical device is switched ON, open the perforator cap and purge the irrigation system.
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5.5 Attaching a tip
The tips that can be used on this medical device are referred to as "second generation". They are recognizable by the
engraving II on the base. They are incompatible with first-generation Implant Center and Piezotome tips.
Conversely, older-generation tips are incompatible with Piezotome Cube, Implant Center Cube, Implant Center 2 LED,
Piezotome 2 and Piezotome Solo LED.
A tip vibrates correctly when it is perfectly tightened without being forced beyond its stop point. Tighten it moderately
using the wrench supplied to ensure optimum ultrasonic function. Over-tightening of the tip can result in breakage of
the tip or handpiece.
To prevent self-locking of the tip, the latter must be removed and sterilised after each use.
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The wrench is a sliding torque wrench.After a few turns, the wrench will seem to slide or turn without
resistance. This means the tightening torque is reached.
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6 Dispensing a treatment
6.1 Accessory usage conditions
The accessories of the Piezotome Cube must be cleaned, disinfected and sterilised before use.
Refer to the cleaning, disinfection and sterilisation protocols for accessories listed in the chapter Associated
documentation page 3.
This medical device is designed to be used in conjunction with a SATELEC, a company of Acteon group
handpiece and second-generation intraoral dental surgery tips.
6.2 Preparation for use
To prepare your medical device, follow the steps below:
1. Wear safety goggles and protective gloves.
2. Put the handpiece support in place.
3. Clean the unit with an alcohol disinfectant wipe.
1. Put the bracket in place.
2. Connect the handpiece cord to the connector on the front of the medical device.
3. Remove the handpiece support from its sterilisation pouch.
4. Remove the handpiece and its cord out of its sterilisation pouch.
5. Remove the wrench from its sterilisation bag.
6. Remove the tip from its sterilisation bag.
7. Screw the tip onto the handpiece, first manually and finishing with the wrench.
8. Place the handpiece on its support.
9. Put an irrigation solution bag in place on the bracket.
10. Remove the irrigation line and its cassette from its sterilisation bag or packaging if sterile.
11. Put in place the irrigation line and its cassette, up to the irrigation bag.
12. Switch on the medical device.
13. Check the irrigation settings according to the chosen tip and adjust the flow via the touch zones.
and .
14. Check the mode according to the chosen tip and adjust the active mode via the touch zones
and .
15. Above a water drain, check that the spray of the handpiece is working properly.
Your medical device is now ready to use.
6.3 Switching off the medical device
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.
This allows the autoclavable irrigation line to be cleaned prior to being disinfected, cleaned and sterilised.
When using irrigation solution bags to irrigate your medical device:
1. Disconnect the irrigation bag from the perforator of the irrigation line.
2. Dispose of the irrigation bag.
3. Dip the short end of the irrigation line in a recipient containing a hypochlorite solution diluted at less than 3%.
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4. Press the Purge icon .
5. Operate the irrigation spray for two minutes to rinse the medical device's internal water system.
6. Refill the tank with demineralised or distilled water.
7. Rinse the irrigation system for two minutes.
When the irrigation system has been cleaned, perform the following operations:
1. Disconnect the handpiece and cord assembly and refer to the J12801 handpiece cleaning, disinfection and
sterilisation protocols.
2. Clean and disinfect the medical device as indicated in the chapter Clean and disinfect the medical device page 23.
3. Refer to the cleaning, disinfection and sterilisation protocols for SATELEC, a company of Acteon group
accessories listed in the chapter entitled chapter Associated documentation page 3.
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7 Medical device description
7.1 Front view of the medical device
7.2 View of the right-hand side of the medical device
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7.3 Rear view of the medical device
7.4 Overview of the interface
D1 mode. The active mode is the illuminated mode.
D2 mode.An inactive mode is not lit.
D3 mode
D4 mode
Tactile zone.Press to change the mode.
Tactile zone.Press to change the mode.
Tactile zone.Press to increase irrigation in steps of 10
ml/min.
Tactile zone.Press to decrease irrigation in steps of 10
ml/min.
Tactile zone.Press and hold the purge time.
Indicator. Lights on when the handpiece-cord assembly is
not connected to the unit.
Indicator.Lights on when communication between the
motherboard and the front-panel board is not
established.The tactile zones of the front face and the
buttons of the pedal are inactive.
Press to switch from one mode to another:
Press to activate the ultrasound.
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