Acteon Cube LED User manual

User Manual
Cube LED handpiece

This document is an English translation of the original French version.
Reference J28820 version V3 and drawing number NO40FR030C

Contents
1 Documentation 3
1.1 Associated documentation 3
1.2 Electronic documentation 3
2 Required information 5
2.1 Indication for use 5
2.2 Operating principle 5
2.3 Using accessories not supplied by the manufacturer 5
2.4 Connecting and disconnecting accessories during use 5
2.5 Repairing or modifying the medical device 5
2.6 Warranty 5
2.7 Latest document update 5
2.8 Date of first CE marking 5
2.9 Accessory usage conditions 5
3 Unpacking the medical device 7
4 Installing the medical device 9
4.1 Handpiece 9
4.2 Handpiece cord 9
4.3 Connecting the handpiece 9
4.4 Attaching a tip 9
5 Dispensing a treatment 11
5.1 Accessory usage conditions 11
5.2 Preparation for use 11
6 Disinfection and sterilising 13
6.1 Clean and disinfect the medical device 13
6.2 Cleaning, disinfecting and sterilising accessories 13
7 Monitoring and routine maintenance 15
7.1 Cleaning the irrigation system 15
8 Identifying incorrect operation 17
8.1 No spray 17
8.2 Ultrasounds not working 17
8.3 Water leakage 17
8.4 No light 17
9 Technical specifications of the medical device 19
9.1 Identification 19
9.2 Handpiece 19
9.3 Light 19
9.4 Length of cords 19
9.5 Irrigation 19
9.6 Environmental characteristics 19
9.7 Environmental restrictions 19
9.8 Main performance characteristics 19
10 Regulations and standards 21
10.1 Applicable standards and regulations 21
10.2 Medical class of the device 21
10.3 Symbols 21
10.4 Quick Start and Quick Clean symbols 22
10.5 Manufacturer identification 23
10.6 Branch addresses 24
10.7 Disposal and recycling 25
11 Index 26

1 Documentation
This document contains the following information:
lIndications for 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
Cube LED handpiece Quick Start-Clean guide J87580
Cube LED handpiece user manual J28821
Cleaning, disinfection and sterilisation instructions for tips J02001
Cleaning, disinfection and sterilisation instructions for keys J81001
Cleaning, disinfection and sterilisation instructions for the Handpiece-piezotome cord assembly J12801
Consulting electronic user instructions J00007
General instructions relating to the complete range of dental ultrasonic generators J00051
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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2 Required information
2.1 Indication for use
The dental surgery ultrasonic handpiece is used with a dental surgery piezoelectric ultrasonic generator and a tip.
Mechanical vibrations are transmitted to an intraoral surgery dental tip attached to the end of the ultrasonic
handpiece.
The treatments performed with this medical device are those described in the User Manual for your ultrasonic
generator.
2.2 Operating principle
This handpiece works on piezoelectric ultrasonic generators designed for dental surgery procedures.
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.
2.3 Using accessories not supplied by the manufacturer
The handpiece is designed to operate with SATELEC, a company of Acteon group dental surgery tips. The use of tips
made by other manufacturers will damage the handpiece, break tips and void the warranty.
2.4 Connecting and disconnecting accessories during use
Do not tighten or loosen the tips when the handpiece is activated.
2.5 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.
2.6 Warranty
Only clearly indicated parts of the medical device can be unscrewed by the user. Unscrewing any other parts may void
the warranty.
2.7 Latest document update
03/2018
2.8 Date of first CE marking
2017
2.9 Accessory usage conditions
The accessories and the handpiece must be cleaned, disinfected and sterilised before use.
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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 handpiece includes the following items:
la handpiece and its cord;
la Quick Start-Clean for the [J87580] handpiece-cord assembly.
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4 Installing the medical device
4.1 Handpiece
The Cube LED handpiece should be used in combination with a dental ultrasonic generator and tips for intraoral
surgery.
Refer to the user manual of the Cube LED J28821 handpiece, and to the protocol for cleaning, disinfecting and
sterilising the J12801 handpieces and cord for further information.
4.2 Handpiece cord
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.
4.3 Connecting the handpiece
Connect the cord and handpiece assembly to the connector on the control unit panel.
Place the handpiece on the support.
4.4 Attaching a tip
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.
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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5 Dispensing a treatment
5.1 Accessory usage conditions
The accessories and the handpiece 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.
5.2 Preparation for use
To prepare your medical device, follow the steps below:
1. Wear safety goggles and protective gloves.
2. Clean the unit with an alcohol disinfectant wipe.
3. Remove the handpiece from its sterilisation bag.
4. Remove the wrench from its sterilisation bag.
5. Remove the tip from its sterilisation bag.
6. Connect the cord and handpiece assembly to the connector on the control unit panel.
7. Install the irrigation line.
8. Install the irrigation bag.
9. Screw the tip onto the handpiece, first manually and finishing with the wrench.
10. Place the handpiece on its support.
11. Switch on the medical device.
12. Check the irrigation parameters depending on the tip chosen.
13. After water drainage, check that the spray works correctly.
Your medical device is now ready to use.
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6 Disinfection and sterilising
The instructions relating to cleaning, disinfection and sterilisation protocols for accessories supplied by SATELEC, a
company of Acteon group have been approved for each medical device and accessory. The applicable guides are listed
in the chapter Associated documentation page 3.
They can be downloaded at the following address: www.satelec.com/documents.
In all cases, the local regulations in force relating to the cleaning, disinfection and sterilisation protocols for
accessories take precedence over the information provided by SATELEC, a company of Acteon group.
6.1 Clean and disinfect the medical device
The medical device's control unit must be cleaned and disinfected daily.
The medical device's control pedal must be cleaned and disinfected daily.
The handpiece and its cord must be cleaned, disinfected and sterilised after use.
The medical device must be in OFF or O stop position during cleaning and disinfecting procedures.
Refer to the instructions in the chapter Cleaning the irrigation system page 15.
Use alcohol disinfectant wipes.
Avoid using cleaning and disinfection products that contain flammable agents.
Otherwise, ensure that the product has completely evaporated or that there is no fuel left on the medical device and its
accessories before switching it on.
Do not use an 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.
6.2 Cleaning, disinfecting and sterilising accessories
Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated
documentation page 3.
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7 Monitoring and routine maintenance
Check the cleanliness of the handpiece nosepiece. It must be clean, smooth and corrosion-free. The handpiece must
screw easily and firmly inside it.
Before and after use, check the medical device and its accessories entirely for any problems. This is necessary to
detect any electrical isolation fault or damage. If necessary, replace damaged parts.
7.1 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.
Operate the device at minimum power, at maximum irrigation flow rate for two minutes.
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8 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 customer service
team at SATELEC, a company of Acteon group.
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.
8.1 No spray
Symptom: There is no water spray at the tip.
Possible causes Solutions
Blocked tip Unblock the tip using an ultrasonic tank
Incorrect choice of tip Check the tip
Inadequate amount of spray Adjust the spray
Irrigation solution bag or bottle empty Install a full container
Irrigation deactivated Activate the irrigation flow
Irrigation line pinched, blocked or faulty Install a new irrigation line.
Do not ever try to unblock a tip or file using a probe.
8.2 Ultrasounds not working
Symptoms: the tip does not vibrate.
Possible causes Solutions
The tip is incorrectly tightened Fasten the tip using the wrench
Replace your torque wrench once a year
Faulty connector contact Clean the cord contacts
Cut handpiece cord Return the handpiece and cord to the Acteon Customer
Service team to have them replaced
8.3 Water leakage
Symptoms: There is a water leak along the irrigation line or at the handpiece and cord assembly.
Possible causes Solutions
Dysfunctional irrigation line Replace the irrigation line with a new one.
8.4 No light
Symptoms: the handpiece does not light up.
Possible causes Solutions
Connection of a handpiece to an ultrasonic generator not
fitted with the LED function
Connect the handpiece to an ultrasonic generator fitted
with the LED function
LED ring missing
Install a blue or white LED ring depending on the
treatment to be performed
Faulty LED ring Order and install a new LED ring
Faulty LED ring connector contacts Clean the LED ring contacts
Faulty cord contacts Return the handpiece and cord to the Acteon Customer
Service team to have them replaced
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Possible causes Solutions
Faulty front face connector contacts Return to the Acteon Customer Service team to replace
the unit
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