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

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AIR-N-GO® easy

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Summary of Contents for Acteon Satelec AIR-N-GO easy

  • Page 1 User Manual AIR-N-GO® easy...
  • Page 2 This is a translation of the original document, which is written in French. Reference J10120 version V4 and plan number ND27FR050D...

  • 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 inclusion of CE 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 3.2 Warning applicable to all countries in which the device is sold...
  • Page 4 7.2 Replacing the O-rings 7.3 Cleaning the air system 7.4 Preventive cleaning 8 Identifying incorrect operation 8.1 Not working 8.2 No spray 8.3 Powder is escaping from the reservoir. 8.4 Water in the powder reservoir 9 Technical specifications of the medical device 9.1 Identification 9.2 Air polisher 9.3 Irrigation...
  • 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 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.

  • 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 installation of the medical device medical device use preparation prior to cleaning and disinfecting the medical device sterilization of the medical device...
  • Page 8 Page 6/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...

  • Page 9: Required Information

    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.

  • 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 devices must adhere (as stated in standard IEC62366).

  • Page 11: Essential Performance

    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.

  • Page 12: Interactions, Contraindications, Prohibitions

    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.

  • 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. The AIR-N-GO®...

  • Page 14: Tightening A Nozzle

    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°...

  • Page 15: Irrigation Flow Configuration Button

    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.
  • Page 16 Page 14/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...

  • Page 17: Cleaning, Disinfecting And Sterilizing

    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.

  • Page 18: Sterilization

    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.

  • Page 19: Monitoring Of The Medical Device

    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.
  • Page 20 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.
  • Page 21 7.4 Preventive cleaning Preventive cleaning must be done whenever the AIR-N-GO® easy is used. Wear protective eyewear. Devices that use a sodium bicarbonate or calcium carbonate based powders are maintained with an aqueous solution with 4% acetic acid, such as an alcohol vinegar whose empirical formula is C , or diluted lemon juice.
  • Page 22 The Perio powder is cleaned using a 27% ethanol aqueous solution. Page 20/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • 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 SATELEC After- Sales team.
  • Page 24 8.3 Powder is escaping from the reservoir. Symptoms: Powder is escaping from the reservoir. Possible causes Solutions The reservoir cover is not tightened Tighten the reservoir cover. completely. Page 22/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • Page 25 Possible causes Solutions Unscrew the reservoir cover. Pour the powder into an infectious medical waste container. The cover's O-ring is improperly Remove the O-ring from the cover and inspect its condition. positioned. Blow on it using the air function on the multifunctional syringe, and clean the There is powder remaining under cover's threading.
  • Page 26 Page 24/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • Page 27 9 Technical specifications of the medical device 9.1 Identification ® Manufacturer SATELEC Name of the medical device AIR-N-GO® easy 9.2 Air polisher Length 180 mm - 205 mm depending on the adapter Height 70 mm - 95 mm depending on the adapter Diameter Max 46 mm Weight...
  • Page 28 Page 26/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • Page 29 Sterilization at 132°C in an autoclave Washer disinfector for thermal disinfection Ultrasonic bath CE marking 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...
  • Page 30 E.mail: satelec@acteongroup.com. www.acteongroup.com Page 28/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • 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 no. 11 H RUSSIA Poligono Industrial Can Clapers ACTEON RUSSIA 08181 SENTMENAT (BARCELONA) - SPAIN Valdajski Proezd 16 – office 243 Tel.
  • Page 32 Page 30/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • Page 33 Glossary: – Adaptor Tank 11 Glossary Pearl Powder Air polishing powder made with calcium carbonate. Adaptor A part that allows the AIR-N-Go easy to be Perio Powder connected directly to the quick coupling on a Air polishing powder made with glycine. dental chair.
  • Page 34 Page 32/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • Page 35 Index: – 27% ethanol steam autoclave with air space 12 Index incorrect operation 21 infectious medical waste container 18 instructions relating to the complete range of dental 27% ethanol 20 ultrasonic generators 3 irrigation flow 12 4% acid solution 19 Maintaining the O-rings 5 maintenance material 11 Manufacturer 25...
  • Page 36 Index: – sterilization pouches washer-disinfector sterilization pouches 16 supra- and sub-gingival 7 Supra 120° nozzle 12 syringe 11, 16 Temperature 25 tests 12 update 7 User Manual 3 washer-disinfector 16 Page 34/35 - User Manual • AIR-N-GO® easy • J10129 • V5 • 11 • 10/2015 • ND27US050E...
  • Page 37 Ref: J10129 • V5 • 11 • 10/2015 • ND27US050E 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...

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