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 Connecting and disconnecting accessories during use 2.4 Repairing or modifying the medical device 2.5 Warranty 2.6 Latest document update 2.7 Date of first CE marking 3 Unpacking the medical device 4 Installing the medical device 4.1 Fixing the medical device to a non-removable support...
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8 Disinfection and sterilising 8.1 Clean and disinfect the medical device 8.1.1 Pre-disinfection and cleaning – Manual method 8.2 Cleaning the irrigation system 8.3 Disinfecting and sterilising the Prophypen handpiece 8.3.1 Pre-disinfection and cleaning – Manual method 8.3.2 Sterilisation 9 Monitoring and routine maintenance 9.1 Cleaning the air circuit 9.1.1 Performing preventive cleaning 9.1.2 Replacing the air filter...
1.1 Associated documentation This document must be used in association with the following documents: Document title References Consulting electronic user instructions J00007 General instructions relating to the Acteon complete range of polishers J10141 AIR MAX user manual J11401 AIR MAX Quick Start I11401...
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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...
2.5 Warranty The screws marked A and B must never be unscrewed by the user. Unscrewing these screws will void the warranty for the medical device. 2.6 Latest document update 12/2017 2.7 Date of first CE marking 2003 Page 8/42 - User Manual | AIR MAX | J11401 | V7 | (03) | 12/2017 | ND07EN010G...
3 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.
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4 Installing the medical device Place the medical device in the position that is suitable for your activity. The medical device must be placed on a secure and flat surface or a surface with a maximum slope of five degrees. Check that the cords do not hinder the movement or free circulation of anyone.
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Procure the relevant kit and the installation and maintenance instructions for water and air filters and cartridges [J11330]. SATELEC, a company of Acteon group accepts no responsibility for damage caused by an installation provided by a service provider that has not been approved by us. ...
5.4 Connect the medical device to the air system Ask an approved dental installation technician to connect your medical device to the air system. The air supply system pressure may vary throughout the day. The air supply system pressure must be adapted to the values recommended for your medical device.
6 Dispensing a treatment 6.1 Accessory usage conditions The accessories of theAIR MAX must be cleaned, disinfected and sterilised prior to each use. Refer to the cleaning, disinfection and sterilisation instructions for accessories listed in the chapter Associated documentation page 5. 6.2 Pre-use test You must perform tests prior to using the medical device on your patients.
6.3.3 Setting the irrigation flow Irrigation flow is set using the ring located on the Prophypen handpiece. The graduations go from 1 to 7. A correctly configured irrigation is required to ensure correct operation of the AIR MAX. Please check the irrigation flow prior to all treatments.
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Assess the amount of powder required for the treatment and add it to the tank. Any surplus powder that is not disposed of in infectious clinical waste containers poses a bacteriological risk for the next patient. In addition, the powder is hygroscopic, which means that when exposed to air, it will very quickly cause blockages. Always purge after using the Prophypen handpiece, no matter for how long.
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7 Medical device description 7.1 Starting and stopping the medical device 7.1.1 Switching on the medical device 1. Turn the mains switch to on (I). 7.1.2 Switching off the medical device Turn the On/Off switch to off (O). 7.2 Description of the medical device in polishing mode 7.2.1 Handpiece cord The cord establishes the irrigation and air flow between the medical device and the handpiece.
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The instructions relating to cleaning, disinfection and sterilisation protocols for accessories provided by SATELEC, a company of Acteon group have been approved for each medical device and accessory. The applicable guides are listed in the chapter Associated documentation page 5.
Repeat the preceding steps until there is no more visible contamination. 8.3.2 Sterilisation Unless otherwise specified, non-sterile products can be resterilised using validated steam sterilisation methods (ISO 17665 or national standards). SATELEC, a company of Acteon group recommends the following: Sterilisation exposure time Sterilisation exposure temperature...
9 Monitoring and routine maintenance The only preventive maintenance the medical device requires is: Monitoring of accessories Routine cleaning, disinfection and sterilisation Cleaning Check the cleanliness of the handpiece nosepiece. It must be clean, smooth and corrosion-free. The nozzle must fit easily and firmly inside it.
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1. Stop the medical device (position O). 2. Unplug the electrical supply. 3. Shut off the water supply. 4. Disconnect the pipe from the device. 5. Unscrew the two filter sections. Page 24/42 - User Manual | AIR MAX | J11401 | V7 | (03) | 12/2017 | ND07EN010G...
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6. Check that there is no leakage and that the spray works correctly. A damaged or blocked cartridge must be replaced. User Manual | AIR MAX | J11401 | V7 | (03) | 12/2017 | ND07EN010G - Page 25/42...
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The nozzle is blocked Without rinsing it, screw the nozzle back onto the handpiece Actuate the handpiece and test it If there is still a blockage, contact Acteon's Customer Services team Wear safety goggles. Devices that use sodium bicarbonate and calcium carbonate powders are cleaned with a 4% acetic The Prophypen handpiece is clogged.
Possible causes Solutions Contact Acteon's Customer Service team to replace the The air pipe is crushed and leaks air pipe. 10.4 Powder coming out of the tank Symptoms: powder is coming out of the tank Possible causes Solutions The tank plug is not screwed on properly.
11 Corrective Maintenance In the event of faulty operation, the following corrective maintenance actions may be performed by the user. 11.1 Replacing the fuses The medical device is protected by two fuses in the mains connector. To replace the fuses, perform the following operations: 1.
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Capacity of the powder container 50 g 12.6 Main performance characteristics 12.6.1 Polishing mode pressure/air flow pressure/water flow Acteon dental powder with a controlled grain size. 12.7 Environmental characteristics Ambient operating temperature +10°C to +40°C Operating RH 30% to 75 %...
Maximum operating altitude Less than 2000 metres Storage temperature 0 to +50°C Storage RH 10% to 100 %, including condensation Atmospheric storage pressure Between 500 hPa and 1060 hPa 12.8 Environmental restrictions Usable in all medical premises. The medical device must not be used Usage premises in an operating theatre or outdoors.
13 Regulations and standards 13.1 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. 13.2 Medical class of the device Class of medical device: IIa according to 93/42/EEC directive 13.3 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 Type LF part in contact Electromagnetic interference CE marking CE marking Year of manufacture YYYY Manufacturer...
Maintenance or repair procedures performed by people who are unauthorised by the manufacturer. 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 36.
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Glossary: – C2H4O2 Unit 14 Glossary Unit Main part of the medical device, which accommodates the settings, tanks and handpiece C2H4O2 holders. Also called console an acetic acid molecular formula used to service devices used with sodium bicarbonate or calcium carbonate powders.
Index: – 4 % acid solution update 15 Index incorrect operation 27 4 % acid solution 23, 27 mains connector 14, 29 Mains power 14 Manufacturer 31 air system 14 MAX 19 altitude 32 medical class 33 approved dealers 7 nozzle 7 cartridge 23 cleaned 15...
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Index: – water filter water system water filter 23 water system 13 Page 41/42 - User Manual | AIR MAX | J11401 | V7 | (03) | 12/2017 | ND07EN010G...
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User Manual | AIR MAX | J11401 | V7 | (03) | 12/2017 | ND07EN010G 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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Questions and answers
What are the part numbers for the air filter and water filter replacements for the Acteon Satelec Air Max polisher?