Acteon Air Max User manual

User Manual
AIR MAX

This document is an English translation of the original French version.
Reference J11400 version V7 and drawing number ND07FR010G

Contents
1 Documentation 5
1.1 Associated documentation 5
1.2 Electronic documentation 5
2 Required information 7
2.1 Indication for use 7
2.2 Operating principle 7
2.3 Connecting and disconnecting accessories during use 7
2.4 Repairing or modifying the medical device 7
2.5 Warranty 8
2.6 Latest document update 8
2.7 Date of first CE marking 8
3 Unpacking the medical device 9
4 Installing the medical device 11
4.1 Fixing the medical device to a non-removable support 11
4.2 Install cords 11
4.3 Installing the control pedal 11
4.4 Connecting the Prophypen handpiece 11
4.4.1 Fitting a nozzle 11
4.5 Handpiece support 11
5 Connect the medical device 13
5.1 Connecting the medical device to the water system 13
5.2 Connecting the medical device to the water system 13
5.3 Installing a water filter 13
5.4 Connect the medical device to the air system 14
5.5 Connecting the medical device to the air supply 14
5.6 Connecting the medical device to the electrical network 14
5.7 Connecting the medical device to the electrical network 14
6 Dispensing a treatment 15
6.1 Accessory usage conditions 15
6.2 Pre-use test 15
6.3 Polishing mode 15
6.3.1 First use 15
6.3.2 Filling the tank 15
6.3.3 Setting the irrigation flow 16
6.3.4 Using the medical device 16
6.3.5 Purging the Prophypen handpiece and cord 16
6.3.6 Emptying the powder container 16
6.3.7 Useful tips 16
7 Medical device description 19
7.1 Starting and stopping the medical device 19
7.1.1 Switching on the medical device 19
7.1.2 Switching off the medical device 19
7.2 Description of the medical device in polishing mode 19
7.2.1 Handpiece cord 19
7.2.2 Handpiece 19
7.2.3 Powder tank 19
7.3 User interface 19
7.3.1 Control unit 19
7.3.2 Control pedal 19
7.4 Switch 19
7.5 Fuse recess 19

8 Disinfection and sterilising 21
8.1 Clean and disinfect the medical device 21
8.1.1 Pre-disinfection and cleaning – Manual method 21
8.2 Cleaning the irrigation system 21
8.3 Disinfecting and sterilising the Prophypen handpiece 22
8.3.1 Pre-disinfection and cleaning – Manual method 22
8.3.2 Sterilisation 22
9 Monitoring and routine maintenance 23
9.1 Cleaning the air circuit 23
9.1.1 Performing preventive cleaning 23
9.1.2 Replacing the air filter 23
9.1.3 Replace the air filter 23
9.2 Clean the water filter cartridge. 23
10 Identifying incorrect operation 27
10.1 Not working 27
10.2 No spray 27
10.3 Air leakage 27
10.4 Powder coming out of the tank 28
11 Corrective Maintenance 29
11.1 Replacing the fuses 29
12 Technical specifications of the medical device 31
12.1 Identification 31
12.2 Control unit 31
12.3 Generator 31
12.4 Length of cords 31
12.5 Irrigation 31
12.6 Main performance characteristics 31
12.6.1 Polishing mode 31
12.7 Environmental characteristics 31
12.8 Environmental restrictions 32
13 Regulations and standards 33
13.1 Applicable standards and regulations 33
13.2 Medical class of the device 33
13.3 Symbols 33
13.4 Manufacturer identification 35
13.5 Manufacturer responsibility 35
13.6 Branch addresses 36
13.7 Disposal and recycling 37
14 Glossary 39
15 Index 40

1 Documentation
This document contains the following information:
lPatient, practitioner and environment safety
lInstalling your medical device in optimum conditions
lIdentifying the manufacturer or the latter's representatives if necessary
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
Consulting electronic user instructions J00007
General instructions relating to the Acteon complete range of polishers J10141
AIRMAX user manual J11401
AIRMAX Quick Start I11401
Prophypen user manual I10540
Air and water filter and cartridge replacement and installation instructions J11330
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.
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 Indication for use
This medical device is designed for supragingival prophylactic treatments of dental and prosthetic surfaces.
It is used with Acteon dental polishing powders.
2.2 Operating principle
Air, water and air polishing powder are supplied to the medical device. The air fed into the closed tank suspends the
powder, which is projected onto the treatment site via a nozzle. Air, water and powder are mixed when they come out
of the medical device.
The air polishing handpiece is designed to operate with SATELEC, a company of Acteon group dental nozzles. Use of
nozzles made by other manufacturers will cause damage to the handpiece.
The medical device is designed to be used only with Acteon Classic or Pearl polishing powders.
The use of other powders may cause the device to function incorrectly or compromise its effectiveness and the safety
of your patients.
2.3 Connecting and disconnecting accessories during use
To prevent powder from spraying all over the surgery, the powder tank must not be opened when the AIRMAX is in
use.
Do not disconnect the nozzle of the polishing handpiece and the Prophypen handpiece from the cord.
Do not tilt the medical device when there is powder in the tank.
2.4 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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2.5 Warranty
The screws marked A and B must never be unscrewed by the user. Unscrewing these screws will void the warranty for
the medical device.
2.6 Latest document update
12/2017
2.7 Date of first CE marking
2003
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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 AIRMAX includes the following items:
lA AIRMAX unit
lA single footswitch
lA Prophypen handpiece that can be disconnected from the cord, but whose cord cannot be disconnected from
the unit
lA titanium nozzle
lA maintenance kit for the polishing handpieces
lA I11401 Quick Start
lAn air pipe
lA water pipe
lBottles of air polishing powder
lAn attachment kit
lA test box
lA power cord
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4 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 access.
Do not install your medical device near or on another device.
4.1 Fixing the medical device to a non-removable support
After its initial installation, the medical device is not designed to be moved. The medical device must be fixed to ensure
that it cannot be removed or moved without the use of a tool.
4.2 Install cords
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 handpiece must be easily accessible. Make sure that the cord is slack during use.
4.3 Installing the control pedal
The control pedal must be positioned near the feet of the operator and must be readily accessible.
4.4 Connecting the Prophypen handpiece
Check for any traces of humidity on the handpiece connections. If the connections are damp, dry them with the multi-
purpose syringe.
1. Disconnect the handpiece from the cord connector.
2. Turn slightly clockwise to lock the handpiece.
4.4.1 Fitting a nozzle
Press the nozzle into the Prophypen handpiece and screw the nozzle by hand until mechanical contact is made.
4.5 Handpiece support
The support holds the handpiece or the cord sleeve.
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5 Connect the medical device
5.1 Connecting the medical device to the water system
Ask an approved dental installation technician to connect your medical device to the water system.
The water supply system pressure may vary throughout the day. The water supply system pressure must be adapted
to the values recommended for your medical device. It is very important to make sure that the maximum pressure
permitted for the medical device is never reached or exceeded. If in doubt, you are strongly advised to install or
arrange for installation of a water pressure limiting system.
1. Water supply connector
5.2 Connecting the medical device to the water system
The supply pipe connector is used to connect the medical device to the domestic water distribution system. The
connector is extended by a pipe to which you must attach a filter.The filter needs to be cleaned and replaced regularly
as specified in the chapter Clean the water filter cartridge. page 23.
The water supply must comply with the quality criteria compatible with the practice of dental treatments.
5.3 Installing a water filter
Water supplied by the system in place may not be of a quality suitable for dental treatments.In this case, you must
install a water filter on the medical device's water supply pipe.
Procure the relevant kit and the installation and maintenance instructions for water and air filters and cartridges
[J11330].
SATELEC, a company of Acteon group accepts no responsibility for damage caused by an installation provided
by a service provider that has not been approved by us.
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5.4 Connect the medical device to the air system
Ask an approved dental installation technician to connect your medical device to the air system.
The air supply system pressure may vary throughout the day. The air supply system pressure must be adapted to the
values recommended for your medical device. It is very important to make sure that the maximum pressure permitted
for the medical device is never reached or exceeded. If in doubt, you are strongly advised to install or arrange for
installation of an air pressure limiting system.
The air supply system must comply with the quality criteria compatible with the practice of dental treatments.
5.5 Connecting the medical device to the air supply
The air filter and air pipe with CPC quick coupling are located on the back of the medical device. Connect the quick
coupling to the air supply inlet.
1. CPC quick air coupling
5.6 Connecting the medical device to the electrical network
Have your medical device connected to the mains power by an approved dental installation technician.
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.
5.7 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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6 Dispensing a treatment
6.1 Accessory usage conditions
The accessories of theAIRMAX must be cleaned, disinfected and sterilised prior to each use.
Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated
documentation page 5.
6.2 Pre-use test
You must perform tests prior to using the medical device on your patients. Perform your tests on a piece of oxidized
metal, such as a coin.
6.3 Polishing mode
6.3.1 First use
To prepare your medical device, follow the steps below:
1. Wear safety goggles and protective gloves.
2. Provide your patient with safety goggles.
3. Clean the unit with an alcohol wipe.
4. Remove the handpiece from its sterilisation bag.
5. Remove the nozzle from its sterilisation pouch.
6. Screw the nozzle onto the handpiece, first manually and finishing with the wrench.
7. Connect the handpiece to the handpiece cord socket.
8. Place the handpiece on its support.
9. Fill the powder container.
10. Switch on the medical device.
11. Check that the air and powder spray works correctly above a sink.
Your medical device is now ready to use.
6.3.2 Filling the tank
1. Switch off the medical device to depressurise the powder container.
2. Unscrew the plug.
3. Blow around the seal of the plug and the tank threads with an air syringe to remove any powder residue.
4. Fill the tank with the required quantity of air polishing powder for the treatment, without exceeding MAX.
5. Screw on the plug.
6. Switch on the medical device and check that the powder container is again pressurised and that there are no air
leaks.
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6.3.3 Setting the irrigation flow
Irrigation flow is set using the ring located on the Prophypen handpiece. The graduations go from 1 to 7. A correctly
configured irrigation is required to ensure correct operation of the AIRMAX.Please check the irrigation flow prior to all
treatments.
1. Irrigation flow adjusting ring
Because work habits, feedback and professional training differ from one professional to another, the user must ensure
that the irrigation flow is compatible with the procedure to be carried out.
1. Point the nozzle towards the test box and press the pedal.
2. Adjust the irrigation flow using the adjusting ring, in accordance with the following instructions:
a. The powder builds up on the box: increase the irrigation flow.
b. There is no powder left on the box and the box is soaked: reduce the irrigation flow.
The flow is correct when the powder is immediately evacuated with the water.
6.3.4 Using the medical device
The patient and the practitioner must wear safety goggles. The practitioner must also wear a mask.
Install a large surgical-type suction cannula and keep it near the area being treated.
Apply medical Vaseline to the patient's lips and commissures before polishing.
1. Point the nozzle at the dental enamel, holding it 3 to 5&#160mm away
2. Ensure a spray angle of 30&#160° to 60&#160° between the nozzle and the surface of the tooth
3. Make gentle circular movements over the area being treated
4. Continue treatment until the desired result is obtained
5. Apply a fluoride gel to the patient's teeth.
For an optimum result, ask your patient to refrain from smoking or from eating any foods that could stain their
teeth for 2 to 3hours following treatment.
6.3.5 Purging the Prophypen handpiece and cord
It is imperative to purge the Prophypen handpiece and cord after every use, no matter how short.
Press and hold the Purge button to activate the purge.
The air circuit is active for a few seconds, then stops automatically.
6.3.6 Emptying the powder container
Always empty the powder container if the device will not be used for several hours (e.g., at night). The residual humidity
diminishes the properties of the powder and increases the risk of clogging.
Proceed as follows:
1. Switch off the medical device.
2. Remove the container from the top.
3. Collect the powder with the suction cannula.
4. Clean the container and the plug.
5. Close the tank.
6.3.7 Useful tips
Your medical device features a water heater. Only switch on your medical device a few minutes before use to save
energy and to prevent quick wear of the internal pipes.
When you stop using the handpiece whilst treating a patient, place the handpiece on the holder, nozzle facing
downwards. This will prevent a drop of water entering the air circuit, which would cause a blockage.
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Assess the amount of powder required for the treatment and add it to the tank. Any surplus powder that is not
disposed of in infectious clinical waste containers poses a bacteriological risk for the next patient. In addition, the
powder is hygroscopic, which means that when exposed to air, it will very quickly cause blockages.
Always purge after using the Prophypen handpiece, no matter for how long.
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7 Medical device description
7.1 Starting and stopping the medical device
7.1.1 Switching on the medical device
1. Turn the mains switch to on (I).
7.1.2 Switching off the medical device
Turn the On/Off switch to off (O).
7.2 Description of the medical device in polishing mode
7.2.1 Handpiece cord
The cord establishes the irrigation and air flow between the medical device and the handpiece.
7.2.2 Handpiece
The medical device must be used with a Prophypen handpiece.
7.2.3 Powder tank
The medical device's tank is fitted with a plug. The maximum capacity is shown by the MAX mark on the tank.
7.3 User interface
7.3.1 Control unit
1. Purge button: press any hold for a rinse flow for a few seconds
7.3.2 Control pedal
1. Footswitch connector
2. Footswitch: pressing starts the polishing jet
7.4 Switch
The mains switch is used to switch on (position I) or to stop (position O) the medical device.
7.5 Fuse recess
The recess holds two fuses designed to protect the medical device in the event of overvoltage or an internal fault.
Please read the instructions listed in the chapter Replacing the fuses page 29
Two fuses are used for a 115 V power supply. Refer to the chapter Control unit page 31.
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