Synimix V

Trade name

Synimix V

03700448201331

B-03700448201331

Reference / catalog number

880439

GS1

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

https://www.synimed.com/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P099002ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS

1 warning recorded — scroll inside the panel to see all entries.

• • 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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