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This document is an English translation of the original French version. Reference J28820 version V3 and drawing number NO40FR030C
Contents 1 Documentation 1.1 Associated documentation 1.2 Electronic documentation 2 Required information 2.1 Indication for use 2.2 Operating principle 2.3 Using accessories not supplied by the manufacturer 2.4 Connecting and disconnecting accessories during use 2.5 Repairing or modifying the medical device 2.6 Warranty 2.7 Latest document update 2.8 Date of first CE marking 2.9 Accessory usage conditions 3 Unpacking the medical device 4 Installing the medical device 4.1 Handpiece 4.2 Handpiece cord 4.3 Connecting the handpiece 4.4 Attaching a tip 5 Dispensing a treatment 5.1 Accessory usage conditions 5.2 Preparation for use 6 Disinfection and sterilising 6.1 Clean and disinfect the medical device 6.2 Cleaning, disinfecting and sterilising accessories 7 Monitoring and routine maintenance 7.1 Cleaning the irrigation system 8 Identifying incorrect operation 8.1 No spray 8.2 Ultrasounds not working 8.3 Water leakage 8.4 No light 9 Technical specifications of the medical device 9.1 Identification 9.2 Handpiece 9.3 Light 9.4 Length of cords 9.5 Irrigation 9.6 Environmental characteristics 9.7 Environmental restrictions 9.8 Main performance characteristics 10 Regulations and standards 10.1 Applicable standards and regulations 10.2 Medical class of the device 10.3 Symbols 10.4 Quick Start and Quick Clean symbols 10.5 Manufacturer identification 10.6 Branch addresses 10.7 Disposal and recycling 11 Index
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1 Documentation This document contains the following information: l l l l l l l
Indications for use Medical device description Installation of the medical device Medical device use Preparation for cleaning and disinfection of the medical device Monitoring and general maintenance of the medical device 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
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: l l
a handpiece and its cord; a 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. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.
Wear safety goggles and protective gloves. Clean the unit with an alcohol disinfectant wipe. Remove the handpiece from its sterilisation bag. Remove the wrench from its sterilisation bag. Remove the tip from its sterilisation bag. Connect the cord and handpiece assembly to the connector on the control unit panel. Install the irrigation line. Install the irrigation bag. Screw the tip onto the handpiece, first manually and finishing with the wrench. Place the handpiece on its support. Switch on the medical device. Check the irrigation parameters depending on the tip chosen. 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 Dysfunctional irrigation line
Solutions 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 Connect the handpiece to an ultrasonic generator fitted fitted with the LED function 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 Faulty front face connector contacts
Solutions Return to the Acteon Customer Service team to replace the unit
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9 Technical specifications of the medical device 9.1 Identification Manufacturer
SATELEC, a company of Acteon group
Name of the medical device
Cube LED
9.2 Handpiece Length without cord
131 mm
Diameter maximum
23 mm
Weight with cord
230 g
9.3 Light Light source
LED
Light colour
White
Light colour
Blue
Output Luminous Emittance
15,000 lux minimum
9.4 Length of cords Handpiece cord
2 500 mm +/- 50 mm
9.5 Irrigation Nominal water output flow at the end of the handpiece
10 ml/min to 120 ml/min
9.6 Environmental characteristics Ambient operating temperature
+10°C to +30°C
Operating RH
30% to 75 %
Atmospheric operating pressure
Between 800 hPa and 1060 hPa
Maximum operating altitude
Equal to or less than 2000 metres
Storage RH
10% to 100 %, including condensation
Atmospheric storage pressure
Between 500 hPa and 1060 hPa
Transportation RH
10% to 100 %, including condensation
Atmospheric transportation pressure
Between 500 hPa and 1060 hPa
9.7 Environmental restrictions Usage premises
Usable in all medical premises. The medical device must not be used in an operating theatre or outdoors.
Use in gas-filled atmosphere
The medical device is not designed for use in a type AP or APG gasfilled atmosphere or in the presence of anaesthetic gases.
Immersion
The handpiece must not be immersed.
9.8 Main performance characteristics Ultrasonic vibrations of the tip fitted to the end of the dental surgery ultrasonic handpiece. l
Vibration frequency ≥ 28 kHz.
l
Tip amplitude ≤ 200 µm.
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