Disposable Irrigation Tubing Set for Implant Motors: 10 Sets per Pack

By:Omnia

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SKU:32.F0-139
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$100.00
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Effective irrigation during the creation of the implant site is essential for the success of the procedure. These disposable irrigation tubing sets (sold 10 sets per pack) were developed for the majority of Implant Motors (Physiodispensers) available on the market. 

Each Disposable Set (10 Sets per Pack) Includes:

  • Perforator with air filter Roller to adjust the flow 
  • Integrated peristaltic pump section enables accurate flow and long duration of usage
  • Total length of the line, from peristaltic pump to handpiece, 230 cm.
  • End tip in soft PVC facilitates the connection to the hand piece.
  • Double Internal and External irrigation with Y joint
  • Each set for mechanical irrigation is packed in a sterile medical blister.
  • Roller to effectively regulate or stop the flow of solution.
  • A connector aim to prevent all possible leakage.
  • A tap (Only for REF. 32.F0139) to regulate liquid flow and ensure optimal control.

Each pack contains 10 sets and each set is single use.

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Components Details

Hose, End Tip, Tap (only certain models)

(click image for larger view)
main components of the disposable irrigation set - hose

Connector, Roller, Peristaltic section, Perforator

(click image for larger view)
main components of the disposable irrigation set - connector

Accessories for Double Irrigation

accessoriesFor those who use double irrigation, each package contains a bag with the following accessories: Y joints, S Shaped clips, cord holder hooks.

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)

 

Quality Control

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.

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