Acteon AIR-N-GO easy User Manual
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Acteon AIR-N-GO easy User Manual

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Summary of Contents for Acteon AIR-N-GO easy

  • Page 1 User Manual AIR-N-GO® easy...
  • Page 2 This document is an English translation of the original French version. Reference J10120 version V5 and drawing number ND27FR050E...

  • Page 3: Table Of Contents

    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 Date of first inclusion of EC marking 2.4 Latest document update 2.5 Repairing or modifying the medical device 2.6 Warranty 2.7 Accessory usage conditions 3 Warnings 3.1 Federal Law...
  • Page 4 5.9 Powder tank 5.10 Filling the powder tank 5.11 Dispensing a treatment 5.12 Cleaning the medical device 6 Cleaning, disinfecting and sterilising 6.1 Cleaning and sterilising 6.2 Pre-disinfection 6.3 Cleaning 6.4 Sterilisation 6.5 Storage 7 Checking the medical device 7.1 Lubricating O-rings 7.2 Replacing O-rings 7.3 Cleaning the air circuit 7.4 Performing preventive cleaning...
  • Page 5 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 is therefore a key 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 your medical device's technology, please read the documentation provided carefully.

  • Page 7: Documentation

    1 Documentation This document contains the following information: relating to patient, practitioner and environmental safety; required to install your medical device in optimum conditions; required to contact the manufacturer or representatives if necessary; indications for use; medical device description; medical device installation; medical device use;...
  • Page 8 Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...

  • Page 9: Required Information

    2 Required information 2.1 Indication for use This medical device is designed for supra- and subgingival prophylactic treatments of dental and prosthetic surfaces. It is used with SATELEC ® dental polishing powder. This medical device is designed for the treatment of peri-implantitis with the Perio option. 2.2 Operating principle In polishing mode, air and water are supplied to the medical device.

  • Page 10: Warnings

    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...

  • Page 11: Patient Population Restriction

    3.6 Patient population restriction This medical device must not be used on the following patient populations: infants; pregnant or breastfeeding women due to restrictions associated with the possible use of medical solutions such as anaesthetics; patients with medical issues; patients with allergies; patients with a clinical site not suitable for treatment.

  • Page 12: Interactions, Contraindications, Prohibitions

    4 Interactions, contraindications, prohibitions This includes information relating to the interactions, contraindications and prohibited operations known by SATELEC ® 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: known allergy to one of the ingredients in the polishing powder used;...

  • Page 13: Medical Device Description

    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.

  • Page 14: Attaching A Nozzle

    5.3 Attaching a nozzle The following nozzles can be attached 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. 5.3.1 Supra 120° nozzle The Supra 120°...

  • Page 15: Irrigation Flow Control Knob

    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. 5.8 Irrigation flow control knob Irrigation is controlled from the dental chair. Controlled drop-by-drop irrigation is necessary for the AIR-N-GO® easy to operate correctly.
  • Page 16 Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 17 6 Cleaning, disinfecting and sterilising 6.1 Cleaning and sterilising The instructions relating to cleaning, disinfection and sterilisation of the medical device and accessories provided by SATELEC ® have been approved for each part. Follow the instructions step by step making absolutely sure that you comply with the products and times indicated.
  • Page 18 6.3 Cleaning 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;...
  • Page 19 7 Checking 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 for use with the AIR-N-GO® easy contain bicarbonate of soda, calcium carbonate or glycine.
  • Page 20 7.3 Cleaning the air circuit The tank must be cleaned each time the AIR-N-GO® easy is used. 1. Unscrew the lid from the tank; 2. Pour any remaining powder into an infectious clinical waste container; 3. Actuate the air without the lid on the tank until the tank's inside walls are completely dry; 4.
  • Page 21 7.4 Performing preventive cleaning Preventive cleaning must be carried out each time the AIR-N-GO® easy is used. Wear safety goggles. Devices that use bicarbonate of soda and calcium carbonate powders are cleaned with a 4% acetic acid aqueous solution such as C molecular formula spirit vinegar or diluted lemon juice.
  • Page 22 The Classic and Pearl powders are cleaned using a 4% acetic acid aqueous solution. The Perio powder is cleaned using a 27% ethanol aqueous solution. Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 23 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 ®...
  • Page 24 8.3 Powder coming out of the tank Symptoms: powder is coming out of the tank Possible causes Solutions The tank lid is not screwed on Screw the lid tightly onto the tank. properly Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 25 Possible causes Solutions Unscrew the lid from the tank; Pour the powder into an infectious clinical waste container; The lid O-ring is incorrectly Remove and inspect the lid O-ring; positioned Using the multi-purpose syringe air function, blow to clean the lid There are traces of powder under threads;...
  • Page 26 Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 27 9 Technical specifications of the medical device 9.1 Identification SATELEC ® Manufacturer AIR-N-GO® easy Name of the medical device 9.2 Air polisher Length 180 mm - 205 mm depending on adapter Height 70 mm - 95 mm depending on adapter Diameter 46 mm max Weight...
  • Page 28 Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 29 10 Regulations and standards 10.1 Official Texts 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. 10.2 Medical class of the device Class of medical device: IIa according to 93/42/EEC directive 10.3 Symbols Symbols...
  • Page 30 10.4 Manufacturer identification SATELEC A Company of ACTEON Group 17, avenue 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 Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 31 ACTEON LATINA AMERICA info@de.acteongroup.com Bogotà - COLOMBIA Mobile: +57 312 377 8209 SPAIN carlosandres.vera@es.acteongroup.com ACTEON MEDICO-DENTAL IBERICA, S.A.U. Avda Principal n°11 H RUSSIA Poligono Industrial Can Clapers ACTEON RUSSIA 08181 SENTMENAT (BARCELONA) - SPAIN Valdajski Proezd 16 – office 243 Tel.
  • Page 32 Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 33 Tank clear tank that is part of the AIR-N-GO easy body. C2H6O Has a maximum fill line to ensure correct ope- an ethanol molecular formula used to service ration (MAX).
  • Page 34 Page - User Manual • AIR-N-GO® easy • J10121 • V5 • 11 • 10/2015 • ND27EN050E...
  • Page 35 Index: – 27% ethanol Perio Maintenance nozzle 12 Index fault 17 first inclusion of EC marking 7 first use 13 27% ethanol 17, 20 gas-filled atmosphere 25 general instructions relating to the complete range of ultrasonic dental generators 3 4% acid solution 19 incorrect operation 21 After installation 13 infectious clinical waste container 18...
  • Page 36 Index: – Perio nozzle washer-disinfector Perio nozzle 12 polishing powder 7 Pressure 25 prophylactic treatments 7 Quick Clean 3 Quick Start 3 repair 7 repairer 7 servicing and maintenance equipment 11 silicone grease 17 sterilisation bags 16 supra- and subgingival 7 Supra 120°...
  • Page 37 Ref: J10121 • V5 • 11 • 10/2015 • ND27EN050E 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...

This manual is also suitable for:

F10131F10132F10133F10135

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