ViKyfuser VF

Rigid Shell

Elastomeric Pump for drug administration by continuos infusion

  • BIOCOMPATIBILITY

The implantable medical grade silicone balloon and PVC-DEHP FREE infusional line grant the best biocompatibility of Vikyfuser elastomeric pump (latex and DEHP are totally absent)

 

  • ACCURACY

A new producing system of the silicone medical grade balloon and the presence of a mobile piston assure a precise constancy of pressure and therefore a high accuracy of the flow during the whole infusion (+/- 10%).

ACC_03

The glass flow restrictor assures the best dimensional stability also in case of temperature variation.

MADE IN ITALY Italy

  • PRACTICALITY

PR_01

The Luer Lock filling port, with anti-back valve and 15μ filter, is located directly on the pump shell allowing and firm connection between the filling syringe and the device; it allows the direct injection of the drug solution into the balloon

Automatic priming : an air venting filter on the line and a hydrophobic vented capsule on the distal closure (0,2μ) , assure a fast, complete and automatic priming of the device.

PR_02

MADE IN ITALY Italy

The evident color code on the pump shell allows an immediate identification and check of the flow rate of the pump (in case of Variant Multirate model the color code is the housing of the flow variation module and identify the variation path of the flow rate)

PR_03

PR_04

The presence of a clamp on the line for voluntary and temporarily block of the flow, makes possible a safe and comfortable connection of the elastomeric pump to the patient (no dripping)

MADE IN ITALY Italy

  • SAFETY

 

  • The hard rigid anti-crash housing protects the balloon from external accidental pressures ( no balloon explosion, no flow variation)
  • Transparency of housing and balloon allow an easy inspection of the drug solution inside the balloon
  • The hard container/housing, even if completely transparent, assures an anti-UV protection
  • On line filter with antiparticle 1,2 μ membrane and air-venting hydrophobic 0,02 μ
  • MAIN APPLICATION CLINICAL AREAS

 

  • Oncology
  • Pain management (acute post operative,palliative)

 

 

  • Thalassemia
  • Antibio therapy

 

MADE IN ITALY Italy

  • INFUSIONAL TYPES

 

  • Continuos

IT_01

The infusion is made by a continuos and constant administration of small quantities of drug solution during the time: conventionally ml/h

Important: as conseguence of what above said, it is important to remenber that the infusion duration depends ofe the effective filling volume and on the selected administration flow rate.
Example: 48 ml filling volume, flow rate 2,0 ml/h, effective duration 24 hours (48/2=24).

MADE IN ITALY Italy

  • VOLUMES
  • 48 ml (max 50)
  • 60ml (max 65)
  • 100ml (max 105)
  • 120ml (max 130)
  • 275 ml (max 300)
VOL_1

 

A partial filling is possible in each nominal volume. A partial filling up to the 60% of the nominal volume (example: filling 60 ml in a nominal volume pump of 100 ml) can cause a minimal flow variation (+ 5/7%).
An even lower filling could cause flow variation over the standard of +/-10% .

  • FLOW RATES

flow_1

Vikymed is available to produce devices with further different flow rates on motivated request.

MADE IN ITALY Italy

  • TECHNICAL SPECIFICATION

 

  • Medical Device class IIB
  • Accuracy +/- 10%

 

 

  • Solution viscosity reference : NaCI 0,9%
  • Temperature 31-32 C° (at capillary)

MADE IN ITALY Italy

  • REFERENCE EXPLANATION

 

  • V F xxxx Z 
  • V : Vikyfuser
  • F : fixed Flow
  • x : digit for the identification of the flow rate
  • Z : suffix for volume identification
    XS: 48 ml – S : 60 ml – M : 100 ml – XM : 130 ml – L : 275 ml

Example : VF0020M : cont. Inf. ; 100 ml volume ; 2,0 ml/h
VF0100L : cont. inf. ; 275 ml volume ; 10,0 ml/h

MADE IN ITALY Italy

  • SYNOPTIC TABLE OF VIKYFUSER ELASTOMERIC PUMPS
Code Volume nominal Flow rate Duration nominal up to Packaging
VF0010XS 48 1,0 ml/h 48 h 10 uns per dispenser
VF0020XS 48 2,0 ml/h 24 h 10 uns per dispenser
VF0040XS 48 4,0 ml/h 12 h 10 uns per dispenser
VF0010XS*DFO 48 1,0 ml/h (for DFO) 48 h 10 uns per dispenser
VF0020XS*DFO 48 2,0 ml/h (for DFO) 24 h 10 uns per dispenser
VF0040XS*DFO 48 4,0 ml/h (for DFO) 12 h 10 uns per dispenser
         
VF0005S 60 ml (max 65) 0,5 ml/h 120 h 10 uns per dispenser
VF0010S 60 ml (max 65) 1,0 ml/h 60 h 10 uns per dispenser
VF0020S 60 ml (max 65) 2,0 ml/h 30 h 10 uns per dispenser
VF0040S 60 ml (max 65) 4,0 ml/h 13 h 10 uns per dispenser
VF0050S 60 ml (max 65) 5,0 ml/h 12 h 10 uns per dispenser
VF0010S*DFO 60 ml (max 65)  1,0 ml/h (for DFO) 60 h 10 uns per dispenser
VF0020S*DFO 60 ml (max 65)  2,0 ml/h (for DFO) 30 h 10 uns per dispenser
VF0050S*DFO 60 ml (max 65)  5,0 ml/h (for DFO) 12 h 10 uns per dispenser
         
VF0005M 100 ml (max 115) 0,5 ml/h 200 h 10 uns per dispenser
VF0010M 100 ml (max 115) 1,0 ml/h 100 h 10 uns per dispenser
VF0020M 100 ml (max 115) 2,0 ml/h 50 h 10 uns per dispenser
VF0040M 100 ml (max 115) 4,0 ml/h 25 h 10 uns per dispenser
VF0050M 100 ml (max 115) 5,0 ml/h 20 h 10 uns per dispenser
         
VF0005XM 120 ml (max 135) 0,5 ml/h 240 h 10 uns per dispenser
VF0010XM 120 ml (max 135) 1,0 ml/h 120 h 10 uns per dispenser
VF0020XM 120 ml (max 135) 2,0 ml/h 60 h 10 uns per dispenser
VF0025XM 120 ml (max 135) 2,5 ml/h 48 h 10 uns per dispenser
VF0040XM 120 ml (max 135) 4,0 ml/h 30 h 10 uns per dispenser
VF0050XM 120 ml (max 135) 5,0 ml/h 24 h 10 uns per dispenser
         
VF0010L 275 ml (max 300) 1,0 ml/h 275 h 10 uns per dispenser
VF0015L 275 ml (max 300) 1,5 ml/h 183 h 10 uns per dispenser
VF0020L 275 ml (max 300) 2,0 ml/h 130 h 10 uns per dispenser
VF0050L 275 ml (max 300) 5,0 ml/h 55 h 10 uns per dispenser
VF0080L 275 ml (max 300) 8,0 ml/h 34 h 10 uns per dispenser
VF0100L 275 ml (max 300) 10,0 ml/h 27 h 10 uns per dispenser
         

Infusion duration depends on the filling volume and the adopted flow rate

MADE IN ITALY Italy

  • CERTIFICATIONS AND QUALITY SYSTEM MANAGEMENT

 

  • Conformity: ISO 28620
  • Biocompatibility: ISO 10993
  • Light transmittance test: nr 2499/2015

 

All the Vikymed products are made in Italy…take the chance and visit us!