Contents 1 Documentation 1.1 Associated documentation 1.2 Electronic documentation 2 Warnings 2.1 Federal Law 2.2 Warning applicable to all countries in which the device is sold 2.3 User population 2.4 Specific user training 2.5 Patient population 2.6 Patient population restriction 2.7 Parts of the body or types of tissues treated 2.8 Applied parts 2.9 Essential performance...
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8.6 Sterilisation 8.7 Storage 9 Monitoring and routine maintenance 9.1 Performing preventive cleaning 9.2 Lubricating O-rings 9.3 Corrective Maintenance 9.3.1 Replacing O-rings 10 Identifying incorrect operation 10.1 Not working 10.2 No spray 10.3 Powder coming out of the tank 10.4 Water in the powder tank 11 Technical specifications of the medical device 11.1 Identification 11.2 Air polisher...
1 Documentation This document contains the following information: Patient, practitioner and environment safety Installing your medical device in optimum conditions Identifying the manufacturer or the latter's representatives if necessary Indications for use Medical device description Installation of the medical device Medical device use Preparation for cleaning and disinfection of the medical device Medical device sterilisation...
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).
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...
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 satelec@acteongroup.com...
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.
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.
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.
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.
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 mm away 3. Ensure a spray angle of 30 ° to 60 ° between the nozzle and the surface of the tooth 4.
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.
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.
1. Remove the nozzle and the body from the washer-disinfector: 2. Dry them 3. Pack each individual part in its own sterilisation bag 4. Sterilise them in a vacuum steam autoclave steriliser according to the usual cycle in your activity area: In Europe, depending on the country: 18 minutes at 134°C and 20 minutes drying time;...
9 Monitoring and routine maintenance The only preventive maintenance the medical device requires is: Monitoring of accessories Routine cleaning, disinfection and sterilisation Cleaning 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.
9.2 Lubricating O-rings After a certain time, the O-rings on the AIR-N-GO® easy body may dry out and become defective. They should be lubricated with the silicone grease supplied by Acteon as follows: Remove the AIR-N-GO® easy body and the nozzle...
Wipe off any excess grease with a dry, lint-free cloth Condition the body of the AIR-N-GO® easy pending its next use Never use turbine spray lubricant to lubricate the O-rings. This will damage them instantly and render them irreparable. Never apply grease to the O-ring inside the container plug as this will instantly block the AIR-N-GO® easy. 9.3 Corrective Maintenance In the event of faulty operation, the following corrective maintenance actions may be performed by the user.
Connect the handpiece to the quick coupling with the tank empty and clean Actuate the handpiece and test it If there is still a blockage, contact Acteon's Customer Services team If the AIR-N-GO® easy works, unscrew the nozzle and rinse it under water, then screw the nozzle back onto the handpiece.
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Possible causes Solutions Remove the tank plug. Dispose of the powder in an infections clinical waste container. Adjust the irrigation flow to drop-by-drop The irrigation flow is not adjusted Purge the air circuit Wipe the inside walls of the tank with a dry, lint-free cloth.
Fill the tank to the maximum level with suitable powder Screw the plug back onto the tank. Contact Acteon Customer Service team to replace the The plug O-ring is defective. plug seal. Contact Acteon Customer Service team to replace the The tank is cracked tank.
Use in gas-filled atmosphere filled atmosphere or in the presence of anaesthetic gases. Immersion The handpiece must not be immersed. 11.6 Main performance characteristics pressure/air flow pressure/water flow Acteon dental powder with a controlled grain size. User Manual | AIR-N-GO® easy | J10121 | V8 | (11) | 03/2018 | ND27EN050H - Page 29/40...
12 Regulations and standards 12.1 Applicable standards and regulations This medical device complies with the essential requirements of European Directive 93/42/EEC. It was designed and manufactured in accordance with an EN ISO 13485-certified quality assurance system. 12.2 Medical class of the device Class of medical device: IIa according to 93/42/EEC directive 12.3 Symbols Symbol...
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Symbol Meaning Fragile, handle with care Store in a dry place Biohazard Sterilisation at 134°C in an autoclave Sterilisation at 132°C in an autoclave Washer-disinfector for thermal disinfection Ultrasonic bath CE marking CE marking Year of manufacture YYYY Manufacturer Do not dispose of as household waste Recycle your lamps and professional electrical equipment with Récylum Under the United States Federal Law, this medical device must only be Rx Only...
Clean under running water Use a washer-disinfector for cleaning and disinfection Use a pre-vacuum air autoclave for sterilisation 12.5 Manufacturer identification SATELEC A Company of ACTEON Group 17, avenue Gustave Eiffel BP 30216 33708 MERIGNAC cedex France Tel. +33 (0) 5.56.34.06.07 Fax.
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Use on an electrical fixture that is not compliant with regulations in force. Use of the device for purposes other than those specified in this manual. Use of accessories or handpiece not supplied by SATELEC, a company of Acteon group . Non-compliance with the instructions contained in this document.
When your medical device has reached the end of its service life, contact your nearest dental equipment dealer, or the Acteon head office or one of the company branches to find out how to proceed. The relevant contact details are given in the chapter Branch addresses page 35.
Tank clear tank that is part of the AIR-N-GO easy body. Has a maximum fill line to ensure correct Infectious clinical waste container operation (MAX). Also called a container.
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User Manual | AIR-N-GO® easy | J10121 | V8 | (11) | 03/2018 | ND27EN050H SATELEC S.A.S. A Company of ACTEON Group 17 av. Gustave Eiffel BP 30216 33708 MERIGNAC cedex FRANCE Tel. +33 (0) 556 34 06 07 Fax. +33 (0) 556 34 92 92 E-mail: satelec@acteongroup.com www.acteongroup.com...
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