Synimix V

Dénomination commerciale

Synimix V

03700448201331

B-03700448201331

Numéro de référence/catalogue

880439

GS1

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Vacuum mixer and application system for low viscosity orthopedic cement. Compared with traditional methods, this one offers two major advantages: elimination of vapors produced during mixing, since the mixing container is hermetic; and minimization of air bubbles because mixing is carried out under reduced pressure (vacuum). Consequently environmental contamination is lower and mechanical properties of cement are improved. It includes a previously marked Application Cannula that may be easily cut to the desired length. The lateral disposition of the Application Cannula allows the application of cement in restricted or hardly accessible areas.

URL des informations complémentaires

https://www.synimed.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• P099002ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• • It is necessary to have a sterile Synimed V4 Gun available, in good working conditions. • It is also necessary to have a pressure-reducing service available (vacuum), for example: - A Venturi vacuum pump, compressed air or nitrogen, driven, at a pressure between 5 kg/cm2 and 6,5 kg/cm2 ((71.1-92.4)psi), with a male luer terminal. The equipment is connected to this device (pump) through the gas-absorbing cartridge. – A vacuum hole at the surgery room gas-panel, connected through the Raccord coupling (without the vapour-absorbing cartridge). • Cement used should be certified for syringe application / low viscosity, room temperature and application times indicated by the cement manufacturer should be observed.

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