Acteon Satelec AIR-N-GO easy User manual

User Manual
AIR-N-GO® easy

This is a translation of the original document, which is written in French.
Reference J10120 version V4 and plan number ND27FR050D

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 Date of inclusion of CE marking 7
2.4 Latest document update 7
2.5 Repairing or modifying the medical device 7
2.6 Warranty 7
2.7 Accessory usage conditions 7
3 Warnings 8
3.1 Federal Law 8
3.2 Warning applicable to all countries in which the device is sold 8
3.3 User population 8
3.4 Specific user training 8
3.5 Patient population restriction 8
3.6 Parts of the body or types of tissues treated 8
3.7 Applied parts 8
3.8 Essential performance 9
3.9 Basic safety in normal use 9
3.10 Normal usage conditions 9
4 Interactions, contraindications, prohibitions 10
4.1 Contraindications 10
4.2 Using accessories not supplied by SATELEC® 10
4.3 Prohibited uses 10
5 Medical device description 11
5.1 Removing the medical device from its packaging 11
5.2 Installing the medical device 11
5.3 Tightening a nozzle 12
5.3.1 Supra 120° nozzle 12
5.3.2 Perio easy nozzle 12
5.3.3 Perio nozzle 12
5.3.4 Perio Maintenance nozzle 12
5.4 Tests prior to use 12
5.5 Adjusting the irrigation flow 12
5.6 Turbine adapter 12
5.7 Connecting and disconnecting accessories during use 12
5.8 Irrigation flow configuration button 13
5.9 Powder reservoir 13
5.10 Filling the powder reservoir 13
5.11 Providing treatment 13
5.12 Cleaning the medical device 13
6 Cleaning, disinfecting and sterilizing 15
6.1 Cleaning and sterilizing 15
6.2 Predisinfection 15
6.3 Cleaning 15
6.4 Sterilization 16
6.5 Storage 16
7 Monitoring of the medical device 17
7.1 Greasing the O-rings 17

7.2 Replacing the O-rings 17
7.3 Cleaning the air system 18
7.4 Preventive cleaning 19
8 Identifying incorrect operation 21
8.1 Not working 21
8.2 No spray 21
8.3 Powder is escaping from the reservoir. 22
8.4 Water in the powder reservoir 23
9 Technical specifications of the medical device 25
9.1 Identification 25
9.2 Air polisher 25
9.3 Irrigation 25
9.4 Air 25
9.5 Environmental characteristics 25
9.6 Environmental restrictions 25
9.7 Main performance characteristics 25
10 Regulations and standards 27
10.1 Official Texts 27
10.2 Medical class of the device 27
10.3 Symbols 27
10.4 Manufacturer identification 27
10.5 Branch addresses 29
11 Glossary 31
12 Index 33

Foreword
The SATELEC®medical device that you are about to install and use in your practice is a medical
device designed for professional use. It comprises the chosen tool with which you will provide
treatment within the context of your work.
To ensure optimum safety for yourself and your patients, comfort in your daily practice and to
benefit fully from the technology of your medical device, please read the documentation provided
carefully.
Please refer to the instructions relating to the comprehensive range of SATELEC®air polishers for
the following information:
ldocumentation format;
lthe documentation archiving period;
lwarnings concerning user and patient populations;
lthe treatment area;
lpreparation of parts for sterilization;
ldetailed manual and automatic protocols;
linformation concerning conditioning for sterilization;
lthe medical device usage interactions, contraindications and prohibitions;
ldisposal and recycling of the medical device;
lmanufacturer responsibility.
Please refer to each medical device's user manual, Quick Start guide, and Quick Clean guide for
information about the following:
lunpacking and installing the medical device;
lusing the medical device;
lmonitoring and maintaining the medical device;
ltechnical specifications of the medical device.

1 Documentation
This document contains the following information:
lrelating to patient, practitioner and environmental safety;
lrequired to install your medical device in optimum conditions
lrequired to contact the manufacturer or representatives if necessary
lindications for use;
lmedical device description
linstallation of the medical device
lmedical device use
lpreparation prior to cleaning and disinfecting the medical device
lsterilization 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
AIR-N-GO® easy Quick Start J10100
AIR-N-GO® easy Quick Clean J10101
Maintaining the AIR-N-GO® easy O-rings J10104
AIR-N-GO® easy user manual J10129
Consulting electronic user instructions J00000
The Quick Start and Quick Clean documents are summaries created for your convenience.The only true
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 electronically at the URL provided. The instructions are not
automatically provided in paper format. If the website is not available, please try again later. You have an option to
receive the documentation in paper format within seven days, free of charge, by submitting a request through our
website, by phone, or by email.
The electronic user instructions are available in PDF format (Portable Document Format). You will need to have a PDF
file read software installed to read the electronic version of the 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.
The device user instructions can be consulted at the following address:www.satelec.com/documents
Once you receive it on your device, we ask that you print and/or download all documents or sections of documents that
you may need to consult 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/or
to download the latest version of your device’s user instructions.
Do not use your device without first reading the user instructions.
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2 Required information
2.1 Indication for use
This medical device is designed for prophylactic treatments targeting the supra- and sub-gingival portion of dental and
prosthetic surfaces. It is used in conjunction with dental polishing powder SATELEC®.
This medical device is intended for pre-implantitis treatment with the Perio option.
2.2 Operating principle
In polishing mode, air and water are supplied to the medical device. The air penetrating into the closed reservoir
creates a cloud of powder, which is projected onto the clinical area via a nozzle. The water, air, and powder are mixed
together when exiting the medical device.
2.3 Date of inclusion of CE marking
2011
2.4 Latest document update
10/2015
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®.
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®customer service team:
www.acteongroup.com
[email protected]
SATELEC®at the request of technical personnel working for the network of dealers approved by SATELEC®,
provides all information required to repair the faulty parts on which they may perform repairs.
2.6 Warranty
No part of the medical device other than those which are clearly indicated as such may be unscrewed by the user, as
doing so will void the warranty. Likewise, the jar and the adapter cannot and must not, under any circumstances, be
detached from the body of the medical device.
2.7 Accessory usage conditions
AIR-N-GO® easy plastic bodies and nozzles must be cleaned, disinfected, and sterilized prior to use. The AIR-N-GO®
easy body must be cleaned and disinfected prior to each use. Please refer to the detailed instructions in the chapter
Cleaning, disinfecting and sterilizing page 15
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3 Warnings
3.1 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 dental health
professionals, fit and certified to perform and manage their professional duties.
3.2 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).
3.3 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 sterilization 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
ldisability of the arms that may prevent correct grip of a handpiece
ldisability of the legs that may prevent the use of a control pedal
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.
3.4 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.
3.5 Patient population restriction
This medical device must not be used on the following patient populations:
lpregnant or breastfeeding women due to restrictions associated with the possible use of medical solutions such
as anesthetics;
lpatients with medical issues;
lpatients with allergies;
lpatients with a clinical site not suitable for treatment.
The patient must be calm, relaxed, still, ideally lying flat on a dental chair.
The user is the only person who can decide whether or not to treat his/her patients.
3.6 Parts of the body or types of tissues treated
Treatments must only be carried out on the patient's oral environment.
3.7 Applied parts
The only parts of the medical device that can be put in contact with the patient are the following:
lnozzle
lplastic body
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3.8 Essential performance
As stated in the applicable safety standard pertaining to electrical medical devices, SATELEC®has determined that the
medical device does not perform essential duties.
3.9 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 wears a mask to reduce the risk of inhaling the powder and to control the risk of bacterial or viral
airborne contamination.
3.10 Normal usage conditions
The normal usage conditions are as follows:
lstorage;
linstallation;
luse;
lmaintenance;
ldisposal.
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4 Interactions, contraindications, prohibitions
This includes information relating to the interactions, contraindications and prohibitions known by SATELEC®on the
date on which this document was written.
4.1 Contraindications
Prior to any treatment, please learn about your patient's health. If your patient is in at least one of the following
situations, do not treat him or her.
lknown allergy to one of the components of the polishing powder being used
lendocarditis
limmune deficiency
lunder antibiotic therapy, chemotherapy, or radiation therapy
ldiabetes
lhemophilia
lasthma, chronic bronchitis, or another respiratory problem
Pregnant or breastfeeding women cannot receive treatment using this medical device.
Never direct the medical device toward the eyes, even if it is off.
A sensitivity or allergy to the powder's ingredients may occur during treatment. Thoroughly rinse the mouth to remove
all traces of powder.
4.2 Using accessories not supplied by SATELEC®
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.
Even if the manufacturer or distributor of your accessory claims full compatibility with SATELEC®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®customer services department.
4.3 Prohibited uses
lDo not cover the medical device and/or obstruct any air inlets.
lDo not immerse or use outside.
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 ionizing 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 but wait until
it reaches room temperature.
The medical device may not be stored or used outside the atmospheric pressure and temperature ranges
recommended in the User Manual supplied with your medical device.
Do not use the device for anything other than for its intended purpose.
Do not put water in the powder reservoir, and always use a completely dry powder.
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5 Medical device description
5.1 Removing the medical device from its packaging
When you receive your medical device, check for any damage that may have occurred during transportation. If you
have any questions or requirements, contact your supplier.
If you have received this medical device by mistake, please contact the supplier to arrange for it to be collected.
The AIR-N-GO® easy includes the following items:
la handpiece with a turbine adapter that cannot be disconnected
la SUPRA 120° nozzle
lmaintenance material, including:
la tube of silicone grease
lsilicone grease applicator brushes
lreplacement O-rings
la syringe and a cannula
la cleaning probe with a metal shaft
lmaintenance instructions flyer [J10104],
lQuick Start guide [J10100] ;
lQuick Clean guide [J10101] ;
lstarter kit with ten sticks of Classic powder and two sticks of Pearl powder
Verify that the AIR-N-GO® easy adapter is compatible with your quick coupling.
5.2 Installing the medical device
The AIR-N-GO® easy connects directly to your dental chair's quick coupling.
1. Remove the turbine.
2. Dry the quick coupling using a multifunctional syringe in air position.
3. Leave the turbine off while connecting the AIR-N-GO® easy.
4. Remove the reservoir cover.
5. Connect the quick coupling to the AIR-N-GO® easy adapter.
6. Adjust the water flow until individual drops come out.
7. Wipe the walls of the reservoir with a dry, lint-free cloth.
8. Press the chair's foot pedal to expel any moisture remaining in the hose. Repeat the operation until droplets no
longer can be seen in the wall of the reservoir.
9. Wipe the walls of the reservoir with a dry, lint-free cloth.
10. Fill the reservoir with as much powder as is necessary for the intended treatment.Do not exceed the specified
maximum level.
11. Wipe with a dry, lint-free cloth, and remove all traces of powder on the reservoir's fitting and cover.
12. Check that the O-ring is properly positioned in the reservoir's cover.
13. Reclose the reservoir.
14. Remove the nozzle and body from their sterile pouches.
15. Put them in place and begin the treatment.
In step 8, if there is still moisture on the walls of the reservoir, refer to chapter Water in the powder reservoir
page 23
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.
Check the condition of your quick coupling's O-rings with each use. A defective O-ring could damage your
medical device beyond repair.
Before connecting the AIR-N-GO® easy, dry the chair's quick coupling using the air syringe.
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5.3 Tightening a nozzle
The following nozzles are associated with the AIR-N-GO® easy. Each has is own characteristics that make it possible to
perform complete clinical procedures, in direction relation to the different types of available powders.
5.3.1 Supra 120° nozzle
The Supra 120° nozzle is used in supra-gingival polishing treatments.
It must be used exclusively in combination with Classic or Pearl supra-gingival powders.
5.3.2 Perio easy nozzle
The Perio easy nozzle is used in periodontal polishing treatments for pockets whose depth is between three and five
millimeters.
It must be used exclusively with Perio powder.
5.3.3 Perio nozzle
The Perio nozzle is used in sub-gingival polishing treatments for periodontal pockets.
It must be used exclusively in conjunction with Perio powder.
5.3.4 Perio Maintenance nozzle
The Perio Maintenance nozzle is used in maintenance periodontal treatments involving pockets with a depth of less
than or equal to four millimeters.
It must be used exclusively with Perio powder.
5.4 Tests prior to use
Some tests must be performed before using the medical device on your patients. Select a piece of oxidized metal, such
as a coin, to perform your tests.
5.5 Adjusting the irrigation flow
The irrigation flow is a key element of the proper functioning of the AIR-N-GO® easy.
The irrigation flow configuration button stops the irrigation function at the stop at least and sets the irrigation flow.
5.6 Turbine adapter
The turbine adapter comes with check valves for air and water. Their job is to prevent air or water from moving in the
direction of the dental chair.
5.7 Connecting and disconnecting accessories during use
It is prohibited to disconnect any accessory during use, unscrew the nozzle, or remove the body cover from the AIR-N-
GO® easy.
It is prohibited to open the reservoir while the AIR-N-GO® easy is in operation because the powder could fly
everywhere in the room.
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5.8 Irrigation flow configuration button
Irrigation can be configured on the dental chair. Setting the irrigation to a drop at a time is a prerequisite for the AIR-N-
GO® easy to work properly. Please verify the irrigation setting prior to any treatment.
5.9 Powder reservoir
The medical device's reservoir comes with a cap. The maximum capacity is shown by the MAX mark on the reservoir.
Because the reservoir is attached to the handpiece, neither the reservoir nor its cover can be sterilized.
5.10 Filling the powder reservoir
Check the powder's expiration date.
Fill the reservoir with the powder needed for the intended clinical procedure. Do not exceed the maximum filling line
(MAX) to ensure the proper operation of the AIR-N-GO® easy.
5.11 Providing treatment
The patient and practitioner must both wear protective eyewear. The practitioner also wears a mask.
Set up a large aspiration cannula, and put it near the area being treated.
Apply petroleum jelly to the patient's lips before polishing.
1. Press the pedal for your chair, and adjust the irrigation to individual drops.
2. Point the nozzle toward the tooth enamel, keeping a distance of 3-5 mm.
3. Keep the spray at a 30° to 60° angle between the nozzle and the surface of the tooth.
4. Make slight circular movements on the area being treated.
5. Continue the treatment until achieving a satisfactory result.
6. Apply a fluoride gel to the patient's teeth.
After pressure is removed from the pedal, the air-water spray continues for a few moments. Wait for the stream to
stop completely before removing the device from the patient's mouth in order to protect the mucous membranes.
For optimal results, advise your patient not to smoke or eat foods that could stain the teeth for 2-3 hours after
the treatment.
Protect the parts of the medical device that cannot be sterilized using a plastic film to prevent contamination. The
following parts cannot be sterilized:
lthe reservoir and its cap
lthe back of the handpiece and its turbine adapter
5.12 Cleaning the medical device
After installation and prior to the first use, at the end of a day and after an extended period of non-use of the medical
device, the medical device must be cleaned. Refer to the chapter Cleaning, disinfecting and sterilizing page 15 for
detailed instructions.
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6 Cleaning, disinfecting and sterilizing
6.1 Cleaning and sterilizing
The cleaning, disinfection, and sterilization instructions for the medical device and its accessories supplied by
SATELEC®have been validated for each element. Please refer to them, step by step, paying careful attention to the
products and durations indicated.
Any step performed improperly creates a risk of contamination.
6.2 Predisinfection
1. Clean the outside of the AIR-N-GO® easy with an alcohol-based disinfecting wipe.
2. Unscrew the nozzle.
3. Remove the plastic body.
4. Clean the metal part of the body with an alcohol-based disinfecting wipe.
Do not clean the inside of the reservoir with an alcohol-based disinfecting wipe.
6.3 Cleaning
1. Wash the nozzle under water.
2. Wash the body under water.
3. Remove most of the contamination using a soft brush or swab.
4. Submerge the nozzle and body in an ultrasonic tank containing an alkaline or enzyme solution, in accordance
with the concentration and times recommended by the solution manufacturer.
5. Remove the nozzle and body.
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6. Tap the nozzle on a hard surface to remove any last remaining particles.
7. Rinse the nozzle under water.
8. Rinse the body under water.
9. Use a syringe to rinse the parts that are hard to reach.
10. Dry the nozzle and body using a soft, lint-free disposable cloth.
11. Run the nozzle and body through the washer-disinfector.
6.4 Sterilization
The disposable sterilization pouches must comply with ISO 11 607 or any equivalent standard required by
national regulations.
1. Remove the nozzle and body from the washer-disinfector.
2. Dry them.
3. Package them in a sterilization pouch, with each item in its own pouch.
4. Sterilize them in the steam autoclave with air space according to the normal cycle in your activity area.
In Europe, depending on the country:
l18 minutes at 134°C and 20 minutes of drying
l4 minutes at 134°C and 20 minutes of drying
l3 minutes at 134°C and 20 minutes of drying
A minimum pressure of 2 bars.
In the U.S.A. - 4 minutes at 132 °C with 20 minutes of drying
A minimum pressure of 1.85 bars.
6.5 Storage
Store the sterile items at room temperature in a dry location, away from dust. Prior to use, check the integrity of the
packaging, and if necessary, repeat the sterilization.
If there is visible contamination in the bag, place the item in an infectious medical waste container to be safely
destroyed.
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7 Monitoring of the medical device
Before and after use, check the medical device and its accessories entirely for any problems. This is necessary to
detect any isolation fault or damage. If necessary, replace damaged parts.
The AIR-N-GO® easy is an air polisher that works with polishing powders. Powders associated with the AIR-N-GO®
easy contain sodium bicarbonate, calcium bicarbonate, or glycine, but these three ingredients, packaged as a powder,
are hygroscopic. Allowing the powder to be exposed to ambient air overnight can lead to a clog in the AIR-N-GO® easy.
7.1 Greasing the O-rings
The AIR-N-GO® easy O-rings can dry out over time and no longer serve their purpose. It is recommended to grease
them using the silicone grease supplied by SATELEC®, as follows:
lRemove the AIR-N-GO® easy nozzle and body.
lPour a drop of silicone grease into a cup.
lUsing the supplied brush, take a small amount of the grease and spread it on the indicated O-rings.
lWipe the excess grease with a dry, lint-free cloth.
lPack up the AIR-N-GO® easy body for future use.
Never use turbine grease spray to grease these O-rings, which will cause immediate and irreversible damage.
Never grease the O-ring on the inside of the reservoir cover, which will immediately cause the AIR-N-GO® easy
to clog.
7.2 Replacing the O-rings
Regularly inspect the condition of the O-rings of the AIR-N-GO® easy handpiece. Replace any damaged O-rings with the
[F10121] kit.
If the AIR-N-GO® easy crackles, indicating the presence of air in the water, or if the water forms beads between the
nozzle and the handpiece body, then the O-rings of the AIR-N-GO® easy must be replaced, as indicated.
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7.3 Cleaning the air system
This must be done whenever the AIR-N-GO® easy is used.
1. Unscrew the reservoir cover.
2. Pour the remaining powder into an infectious medical waste container.
3. Run the air without a reservoir cover until there is are no traces of moisture on the inside walls of the reservoir.
4. Wipe the inside walls of the reservoir with a dry, lint-free cloth.
If water droplets continue to appear on the inside walls of the reservoir, check the condition of the O-ring on
your quick coupling.
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