Acteon AIR-N-GO easy User manual

User Manual
AIR-N-GO® easy

This document is an English translation of the original French version.
Reference J10120 version V8 and drawing number ND27FR050H

Contents
1 Documentation 3
1.1 Associated documentation 3
1.2 Electronic documentation 3
2 Warnings 4
2.1 Federal Law 4
2.2 Warning applicable to all countries in which the device is sold 4
2.3 User population 4
2.4 Specific user training 4
2.5 Patient population 4
2.6 Patient population restriction 4
2.7 Parts of the body or types of tissues treated 5
2.8 Applied parts 5
2.9 Essential performance 5
2.10 Basic safety in normal use 5
2.11 Normal usage conditions 5
2.12 Service life 5
3 Required information 7
3.1 Indication for use 7
3.2 Operating principle 7
3.3 Connecting and disconnecting accessories during use 7
3.4 Repairing or modifying the medical device 7
3.5 Warranty 7
3.6 Latest document update 7
3.7 Date of first CE marking 7
4 Interactions, contraindications, prohibitions 9
4.1 Contraindications 9
4.2 Using accessories not supplied by the manufacturer 9
4.3 Prohibited uses 9
5 Unpacking the medical device 11
6 Installing the medical device 13
6.1 Fitting a nozzle 13
6.1.1 Supra 120° nozzle 13
6.1.2 Perio easy nozzle 13
6.1.3 Perio nozzle 13
6.1.4 Perio Maintenance nozzle 14
7 Dispensing a treatment 15
7.1 Accessory usage conditions 15
7.2 Pre-use test 15
7.3 First use 15
7.3.1 Turbine adapter 15
7.3.2 Powder tank 15
7.3.3 Filling the tank 15
7.3.4 Setting the irrigation flow 15
7.3.5 Using the medical device 15
7.4 Switching off the medical device 16
8 Disinfection and sterilising 17
8.1 Cleaning cycle limits 17
8.2 Clean and disinfect the medical device 17
8.3 Containment and transportation 17
8.4 Preparation for pre-disinfection 17
8.5 Pre-disinfection 17

8.6 Sterilisation 18
8.7 Storage 19
9 Monitoring and routine maintenance 21
9.1 Performing preventive cleaning 21
9.2 Lubricating O-rings 22
9.3 Corrective Maintenance 23
9.3.1 Replacing O-rings 23
10 Identifying incorrect operation 25
10.1 Not working 25
10.2 No spray 25
10.3 Powder coming out of the tank 27
10.4 Water in the powder tank 27
11 Technical specifications of the medical device 29
11.1 Identification 29
11.2 Air polisher 29
11.3 Irrigation 29
11.4 Environmental characteristics 29
11.5 Environmental restrictions 29
11.6 Main performance characteristics 29
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 33
12.6 Manufacturer responsibility 33
12.7 Branch addresses 35
12.8 Disposal and recycling 36
13 Index 37
14 Glossary 39

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
lMedical device sterilisation
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
AIR-N-GO® easy Quick Start J10100
AIR-N-GO® easy Quick Clean J10101
AIR-N-GO® easy seal maintenance J10104
AIR-N-GO® easy user manual J10121
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.
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 3/40

2 Warnings
2.1 Federal Law
The indication below applies to the United States of America only.
The United States Federal Law restricts the use of this medical device in its territory to qualified, fit and certified dental
health professionals (either directly or under their supervision).
2.2 Warning applicable to all countries in which the device is sold
The information below is based on the requirements of standards to which the manufacturers of medical
devices must adhere (as stated in standard IEC62366).
2.3 User population
This medical device must only be used by qualified dental health practitioners, fit and certified to perform their
professional duties.
Users must know and comply with the rules of dental practice in compliance with knowledge acquired in the field and
the key medical hygiene principles including cleaning, disinfection and sterilisation of medical devices.
The medical device can be used by any adult dental practitioner of any weight, age, height, gender and nationality.
The user must wear gloves.
The user is not the patient.
The user must not be prone to any of the following:
lvisual impairments: any vision problems must be corrected by glasses or lenses.
larm disability that may prevent the user from holding a handpiece;
lleg disability that may prevent use of a footswitch;
lhearing difficulties that could prevent the user hearing audible alarms depending on medical devices;
ldifficulty memorizing or concentrating that could affect the setting of sequences or the performance of
treatment protocols.
2.4 Specific user training
No specific training other than initial professional training is required to use this medical device.
The practitioner is responsible for performing clinical treatments and for dangers that may arise due to a lack of skill
and/or training.
2.5 Patient population
This medical device is designed to be used with the following patient populations:
lChildren,
lTeenagers,
lAdults,
lOld Age Pensioners.
This medical device can be used on any patient of any weight (except children), age, height, gender and nationality.
Patients wearing prescription glasses or contact lenses must remove them before the treatment and wear the safety
goggles provided during the treatment.
2.6 Patient population restriction
This medical device must not be used on the following patient populations:
lInfants,
lpregnant or breastfeeding women due to restrictions associated with the possible use of medical solutions such
as anaesthetics;
lpatients with medical issues,
lPatients allergic to some of the medical device components,
lpatients with a clinical site not suitable for treatment,
The patient must be calm, relaxed, still, ideally lying flat on a dental chair.
Page 4/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H

The user is the only person who can decide whether or not to treat his/her patients.
2.7 Parts of the body or types of tissues treated
Treatments must only be performed on the patient's oral environment.
2.8 Applied parts
Elements in direct contact with the patient Polishing nozzle
Part in indirect contact with the patient Front body of the medical device
2.9 Essential performance
As stated in the applicable safety standard pertaining to electrical medical devices, The manufacturer has determined
that the medical device did not manage essential performances.
2.10 Basic safety in normal use
The active part, the handpiece is held by the practitioner throughout the treatment. Being medically qualified, the
practitioner is qualified to immediately detect any problem at the treatment site and to react accordingly.
It is advisable to have a spare medical device or an alternative means with which to perform the medical treatment in
the event of device failure.
The practitioner must wear a mask to limit the risk of powder inhalation and to mitigate the risk of bacterial or viral
airborne contamination.
2.11 Normal usage conditions
The normal usage conditions are as follows:
lstorage;
linstallation;
luse;
lmaintenance;
ldisposal.
2.12 Service life
The shape of the nozzles is decisive in achieving the maximum performance of the air polisher. The medical device will
perform best if the user pays attention to this characteristic. Therefore, we strongly advise against the modification of
the structure of the nozzles by filing, twisting or by performing other types of modification.
As it is not possible to establish a maximum number of uses, that may be determined by many parameters such as
frequency of use, duration of use, quality of routine maintenance or the care taken with the parts of the device, we
recommend that the most used nozzles are replaced once a year.
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 5/40

Page 6/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H

3 Required information
3.1 Indication for use
This medical device is designed for supra- and subgingival prophylactic treatments of dental and prosthetic surfaces.
It is used with dental polishing powders Acteon.
This medical device is used with a dental ultrasonic handpiece to which an ultrasonic instrument is attached. It is
designed for prophylaxis, periodontics, endodontics and restorative and conservative dentistry treatments.
With the Perio option, it is used for prevention and maintenance purposes in treated patients and for the treatment of
periodontal diseases: periodontitis and peri-implantitis.
3.2 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.
3.3 Connecting and disconnecting accessories during use
No accessories must be disconnected during use, the nozzle must not be unscrewed and the AIR-N-GO® easy body
protection must not be removed.
To prevent powder from spraying all over the surgery, the powder tank must not be opened when the AIR-N-GO® easy
is in use.
3.4 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.
3.5 Warranty
Only clearly indicated parts of the medical device can be unscrewed by the user. Unscrewing any other parts may void
the warranty. The container and the adapter cannot be and must never be detached from the body of the medical
device.
3.6 Latest document update
03/2018
3.7 Date of first CE marking
2011
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 7/40

Page 8/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H

4 Interactions, contraindications, prohibitions
This includes information relating to the interactions, contraindications and prohibited operations known by the
manufacturer on the date on which this document was written.
4.1 Contraindications
It is important to determine a patient's state of health prior to treatment. If one or more of the following applies to your
patient, please do not treat them:
lknown allergy to one of the ingredients in the polishing powder used
lendocarditis
limmune deficiency
ltaking a course of antibiotics, undergoing chemotherapy/radiotherapy treatment
ldiabetes
lhaemophilia
lasthma, chronic bronchitis or another breathing disorder
Pregnant or breastfeeding women cannot be treated with this medical device.
A sensitivity or allergy to any of the powder ingredients may become apparent during treatment. Rinse the patient's
mouth thoroughly to remove all traces of the powder.
Never point the medical device directly at the eyes even when it is not in use.
4.2 Using accessories not supplied by the manufacturer
The medical device was designed and developed with its accessories to guarantee maximum safety and performance.
The use of accessories from another source could put you and your patients at risk and could damage your medical
device.
Do not try to connect accessories not provided by SATELEC, a company of Acteon group to your medical device
connector(s) or to the handpiece.
The medical device is designed to be used with Acteon Classic, Pearl or Perio polishing powders.
The use of other powders may cause the device to function incorrectly or compromise its effectiveness and the safety
of your patients.
Even if the manufacturer or dealer of your accessory claims full compatibility with SATELEC, a company of Acteon
group equipment, it is advisable to exercise caution with regards to the origin and safety of the product offered. Look
out in particular for lack of information, information in a foreign language, very attractive prices, suspect appearance,
mediocre quality or premature wear. If necessary, contact an approved dealer or the SATELEC, a company of Acteon
group Customer Service team.
The medical device is designed to work with SATELEC, a company of Acteon group nozzles and powders. Using nozzles
or powders from other manufacturers will cause damage to the medical device.
4.3 Prohibited uses
lDo not immerse or use outdoors.
lDo not place the medical device next to a source of heat or in direct sunlight.
lDo not expose the medical device to water spray or mist.
lDo not use the medical device in an AP or APG gas-filled atmosphere.
The medical device is not designed to operate near a source of ionising radiation.
A hot/cold temperature contrast can cause condensation to form in the medical device, which may be dangerous. If the
medical device needs to be moved from a cold place to a warm place, do not use the device immediately. Wait until it
reaches room temperature.
The medical device may not be stored or used outside the temperature, atmospheric pressure and humidity ranges
recommended in the User Manual supplied with your medical device.
Only use the medical device for the purpose for which it has been designed.
Do not put water in the powder container and use a completely dry powder.
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 9/40

Page 10/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H

5 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-N-GO® easy includes the following items:
la handpiece with a non-detachable turbine adapter
la SUPRA 120° nozzle
lservicing and maintenance equipment including:
lsilicone grease tube
lsilicone grease applicator brushes
lspare O-rings
la syringe and a cannula
la metal shaft cleaning probe
la maintenance instructions leaflet [J10104]
lA [J10100]Quick Start guide;
lA [J10101]Quick Clean guide;
la starter kit comprising 10 Classic powder sachets and 2 Pearl powder sachets.
Check that the AIR-N-GO® easy adapter is compatible with your quick coupling.
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 11/40

Page 12/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H

6 Installing the medical device
The AIR-N-GO® easy connects directly to the quick coupling on your dental chair.
1. Remove the turbine
2. Dry the quick coupling using the multi-purpose syringe air function
3. Do not activate the turbine function when connecting the AIR-N-GO® easy
4. Remove the container plug.
5. Connect the turbine coupling to the AIR-N-GO® easy adapter
6. Adjust the water flow to drop-by-drop
7. Wipe the inside walls of the container with a dry, lint-free cloth
8. Press the footswitch to eliminate any moisture still in the circuit. Repeat the procedure until there are no more
droplets on the inside walls of the container
9. Wipe the inside walls of the container with a dry, lint-free cloth
10. Fill the tank with the correct amount of powder for the intended treatment.Fill the container to the indicated
limit
11. Wipe with a dry, lint-free cloth to remove all traces of powder from the container threads and plug
12. Check that the O-ring is correctly seated in the container plug
13. Close the container
14. Remove the nozzle and the body from their sterile bags
15. Install them and start the treatment
If droplets continue to appear on the inside walls of the container in step 8, read the chapter Water in the
powder tank page 27
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. Do not install your medical device near or on another device.
Inspect the condition of the O-rings on your quick coupling prior to each use. A damaged O-ring can cause
irreparable damage to your medical device.
Before connecting the AIR-N-GO® easy, dry the chair's quick coupling using the air syringe.
6.1 Fitting a nozzle
6.1.1 Supra 120° nozzle
The Supra 120° nozzle is used for supragingival polishing treatments.
It is only compatible with Classic and Pearl supragingival powders.
6.1.2 Perio easy nozzle
The Perio easy nozzle is used for periodontal polishing treatments for three to eight millimetre-deep periodontal
pockets.
It is only compatible with Perio powder.
6.1.3 Perio nozzle
The Perio nozzle is used for subgingival polishing treatments for eight to ten millimetre-deep periodontal pockets.
It is only compatible with Perio powder.
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 13/40

6.1.4 Perio Maintenance nozzle
The Perio Maintenance nozzle is used for periodontal maintenance treatments for four millimetre-deep periodontal
pockets or below.
It is only compatible with Perio powder.
Page 14/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H

7 Dispensing a treatment
7.1 Accessory usage conditions
The AIR-N-GO® easy‘s nozzle and plastic tube must be cleaned, disinfected and sterilised before use.
Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Clean and disinfect
the medical device page 17.
7.2 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.
7.3 First use
7.3.1 Turbine adapter
The turbine adapter is equipped with water and air check valves. These prevent any air or water rising back up in the
direction of the dental chair.
The following nozzles can be fitted to the AIR-N-GO® easy. Each nozzle has specific characteristics to enable all clinical
treatments to be performed, in direct association with the various types of powder available.
7.3.2 Powder tank
The medical device's tank is fitted with a plug. The maximum capacity is shown by the MAX mark on the tank.
The tank is part of the handpiece and neither the tank nor its plug can be sterilised.
7.3.3 Filling the tank
Check the expiry date of the powder.
Blow around the seal of the plug and the tank threads with an air syringe to remove any powder residue.
Fill the tank with the required amount of powder for the treatment to be performed. Do not fill past the maximum line
indicated to ensure correct operation of theAIR-N-GO® easy.
7.3.4 Setting the irrigation flow
The irrigation flow can be configured at the dental chair. Drop-by-drop irrigation is required to ensure correct
operation of AIR-N-GO® easy. Please check the irrigation flow prior to all treatments.
7.3.5 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.
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 15/40

Apply medical Vaseline to the patient's lips and commissures before polishing.
1. Press your chair's footswitch to adjust irrigation to drop-by-drop
2. Point the nozzle at the dental enamel, holding it 3 to 5&#160mm away
3. Ensure a spray angle of 30&#160° to 60&#160° between the nozzle and the surface of the tooth
4. Make gentle circular movements over the area being treated
5. Continue treatment until the desired result is obtained
6. Apply a fluoride gel to the patient's teeth.
Air-water will continue to spray for a few seconds after releasing pressure on the footswitch. To protect the mucosa,
wait for the spray to stop completely before removing the device from the patient's mouth.
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.
7.4 Switching off the medical device
Release the footswitch of the chair to switch off the medical device.
Page 16/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H

8 Disinfection and sterilising
The cleaning, disinfection and sterilisation instructions for the medical device and accessories provided by Acteon have
been approved for each part. Follow the instructions step by step, making absolutely sure that you comply with the
products and times indicated.
Any step that is performed without complying with the instructions creates a risk of contamination.
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.
8.1 Cleaning cycle limits
Repeated packaging cycles involving manual washing have little effect on air polishing nozzles. End of service life is
normally determined by wear and damage due to use.
8.2 Clean and disinfect the medical device
After installation and prior to first use, at the end of the day and following an extended period of non-use of the medical
device, it is necessary to clean the medical device.
8.3 Containment and transportation
Soiled devices must be transported separately from non-contaminated devices to avoid any contamination.
8.4 Preparation for pre-disinfection
It is advisable to recondition devices as soon as possible after use. SATELEC, a company of Acteon group devices must
be reconditioned within two hours of use.
8.5 Pre-disinfection
1. Clean the outside of the AIR-N-GO® easy with an alcohol disinfection wipe
2. Unscrew the nozzle
3. Remove the plastic body
4. Clean the metal part of the body with an alcohol disinfectant wipe.
Do not clean the inside of the tank with an alcohol disinfectant wipe.
User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H - Page 17/40

1. Wash the nozzle under water;
2. Wash the body under water
3. Use a soft-bristled brush or a swab to remove most of the contamination
4. Immerse the nozzle and the body in an ultrasonic tank filled with an alkaline or enzymatic solution ensuring
compliance with the concentration and times recommended by the solution manufacturer
5. Remove the nozzle and the body
6. Tap the nozzle on a hard surface to remove any remaining particles;
7. Rinse the nozzle under water;
8. Rinse the body under water
9. Use a syringe to rinse difficult-to-reach parts
10. Dry the nozzle and the body with a single-use soft, lint-free cloth
11. Transfer the nozzle and the body to the washer-disinfector.
8.6 Sterilisation
Single-use sterilisation bags must comply with ISO standard 11 607 or any equivalent standard required by a
national regulation.
Page 18/40 - User Manual|AIR-N-GO® easy|J10121|V8|(11)|03/2018|ND27EN050H