SYNIMIX VTP System

Dénomination commerciale

SYNIMIX VTP System

03700448201386

B-03700448201386

Numéro de référence/catalogue

880440

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 Mixing Device for vertebroplasty, compared with traditional methods, 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). These effects persist when hermetic syringe is filled by direct suction and no additional peak is open. Consequently environmental contamination is lower and mechanical properties of cement are improved.

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.

• • A certified application system for vertebroplasty cement with syringe, with a standard male luer fitting should be available. • It is also necessary to have a pressure-reducing service available (vacuum), for example: - A Venturi vacuum pump driven by compressed air or nitrogen, 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 vapour-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; room temperature and application times indicated by the cement manufacturer must be observed. • Do not discard the inner blister until the procedure is finished; since blister has a cylindrical stand that will sustain the body mixer during the mixture.

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