Accessories for Double Irrigation
Reference Numbers for Motor Systems
Please refer to the following reference codes and corresponding implant motors, to place your order (the codes are visible in the drop down box above). If you do not see your motor listed below, please contact us, as we have other specialized kits available that maybe indicated for your motor system.
Reference F0139: Nobel Biocare80/ W&H Implantmed/ Implant Med new design 2005/ Implantmed SI 923/ Astratech Implant SI 923/ Surgical Motor System/Ace/Strauman/ InnovaCorp. 3I/Centerpulse/Lifecore/ DU 900/ FRIOS® UNIT S/ FRIOS® UNIT S/I, Drilltech/Osseoset 100/Osseoset 200/Osseocare
Reference F0013: Nouvag 3000/Nouvag 7000/MD10, MD20 without tap/Straumann model Nouvag/SM12 Sem2/ SU100/CBM; Novaxa Assistant 2, New assistant Novaxa, Assistant I-XT
Reference F0134 : NSK Surgic XT, Surgic XT Plus, Osseocision®, VarioSurg, SurgicPro, Kyocera Implantor Neo, Bonart Piezo surgical system, Dentium iCTmotor, NSK 3i Osseocision, Delfine Intra-Lock, Saeyang Ki-20
Reference F0105: Aseptico Aeu 6000 series, Aseptico Aeu 7000 series
Reference F0170: Bien Air Chiropro 980 / EMS PIEZON® MASTER surgery/ Esacrom Surgisonic I / UBS- Ultrasonic bone surgery/ Surgybone - Acrobone - Easybone Silfradent, BioSAFin Easy Surgery, MyTUTOR
Reference F0108: Piezosurgery Touch Mectron
Reference F0194: Acteon Implant Centre, Piezotome, Acteon I-Surge, Acteon Solo
Irrigation in Implantology
Effective irrigation during the creation of the implant site is essential for necessary bone integration of the implant, and consequently, for the success of the procedure. For this reason, it is very important that the surgical bur is properly cooled. An adequate, but not excessive flow of coolant liquid can be guaranteed only by an irrigation system which has been developed for a specific drilling unit.
Eriksson, in his papers, set the highest level of temperature increase at 47°C for no longer than 1 minute, in order not to induce thermal necrosis of bone tissue. This parameter was confirmed and analyzed in clinical operations thanks to the research of Watanabe (1992), Gross (1995), Brisman (1996), Cordioli (1997) and Iyer (1997).
External and/or internal irrigation ensures direct cooling of the bone surface and avoids overheating of the bur due to friction.
Guidelines for an atraumatic surgery on hard tissue:
- Use disposable surgical burs or surgical burs that have been used in a limited number of procedures
- Use double and simultaneous, internal and external, irrigation, by means of an Y connection and the supply of a coolant liquid between 800 ml/min and 1200 ml/min
- Maintain bur revolutions between 800 and 1200 rpm
- Adjust the speed and the manual pressure on the surgical bur according to the quality of the bone (dense and compact bone: high speed, high pressure; cancellous bone: low speed, low pressure)
- Use saline solution cooled to about 4° C (39.2° F)
Irrigation lines are disposable medical devices subject to 93/42/EC Directive and update 2007/47/EC and are classified in risk class IIa.
The sterilization process is validated according to EN ISO 11135-1:2007. Irrigation lines are subject to controls and tests on the assembled and final product. They are subjected to three different levels of defectiveness and related AQL (Acceptance Quality Limit), that state the standards of acceptable quality, as required in the provision UNI ISO 2859-1. Tests conducted during the production phase are as follows:
I. Assembly stage
1. Controls on critical defects (for ex. blockage of the hose, damaged components, unsatisfactory gluing) with AQL equal to 0.25, conducted through a blow test on 100% of the products. The test verifies the non obstruction of the line through a blow of compressed air.
2. Primary defects (for ex. bend/constriction of the hose, traces of solvent) with AQL equal to 1.0
3. Secondary defects (for ex. inaccurate moulding, spots or burns on components) with AQL equal to 2.5
4. Watertight test carried out according to ISO 2859-1 charts with AQL equal to 1.0, with specified test equipment, according to test specifications defined in the reference standard UNI EN ISO 8536 (test pressure not lower than 50kPa for 15 sec.)
II. Packaging stage
1. Critical defects (for ex. missing/incomplete data on labels, welding defects)
2. Primary defects (for ex. missing instructions of usage, wrong number of pieces) with AQL equal to 1.0
3. Secondary defects (for ex. damaged cartons, missing packing tape) with AQL equal to 2.5
All devices are tested at the end of production in order to ensure conformity to the technical specification stated and to the Essential Requirements defined by the Directive.
1. All marks mentioned above for specific motor systems are the Trademarks® of the respective manufacturers.
Research No Size No Unit No Manufacturer Omnia SPA