STERILE PVC 3-WAY INFUSION SET WITHOUT DEHP 3X4,1 2 3-WAY VALVES 1 MOBILE LUER LOCK NON-RETURN VALVE FILTER DRAIN 235CM

Référence : PER3R3VF02

  • DEHP-free (<0.1% w/w)
  • Designed to minimize the environmental footprint by reducing the weight of plastic materials.
  • Packaging developed with end-users to provide easy readability of key information needed immediately.

Description

The sterile, DEHP-free INFINEED 3-way infusion set with 2 stopcocks has been designed to minimize its environmental impact, using only DEHP-free raw materials (eliminating components containing DEHP). The polycarbonate-free 3-way stopcocks have been tested at pressures well in excess of those recommended for gravity perfusion; laboratory tests have shown a pressure resistance of around 10 bar.

Perforator available:
- Perforator: Bicanal with gripping wings.
- Air intake: Supplied closed for immediate use on bag (except for infusers with non-return valve) - 1.2µ filter.
- Chamber: Flexible and translucent, the chamber is calibrated to 20 drops = 1ml ± 0.1ml. 15µ anti-particle filter.
- Wheel: Precise and reliable, linear flow regulator.
- Tubing: PVC, DEHP-free, designed for even adjustment. Tube diameter: 3 x 4.1mm.
- End cap: Luer Lock mobile.
- End cap: 0.8 µm purge filter with hydrophobic antibacterial membrane.
- Bisphenol A-free 3V valves.
- Polycarbonate and silicone non-return valve.
Tube dead volume: 15.90ml.
Chamber dead volume: 5.10ml.

Made in China.

Informations
techniques

Indications 
This device enables gravity administration of injectable parenteral preparations: drugs, solutions, parenteral nutrition when the use of two 3-way valves is required (anesthesia, obstetrics). For peripheral lines, the infusion line can remain in place for a maximum of 96 hours (i.e., the maximum duration of peripheral catheter insertion). For central lines, the infusion line must be changed at least every 72 hours (or according to the institution's validated protocol). To disinfect connections, use 70° alcohol, which is highly compatible. Caregivers are increasingly using chlorhexidine 2% in 70% isopropyl alcohol. This type of solution is known to be very aggressive to plastics. For this reason, Didactic conducted laboratory tests on the contact of connections with this type of disinfectant. The results showed that the connections were fairly resistant to this composition when in relatively short contact (less than 1min) with a swab soaked in disinfectant solution without excess (1 to 2ml per swab). Gravity infuser, not to be used for pressurized infusion, notably injection of contrast media. Not to be used for transfusions, or for drugs requiring a 0.2µm filter.

Matériaux utilisés 
PVC: Chamber, air intake, DEHP-free tubing. Polyethylene: Purge filter, cap, perforator protector. Acrylonitrile Butadiene Styrene: perforator, mobile Luer Lock, linear flow regulator. Nylon: Particle filter. PC: Non-return valve. Polypropylene: Protective tap caps. High density polyethylene HDPE: Faucet key. BPA-free Tritan ® copolymer: Faucet body. Silicone: Lubricant, tap, non-return valve.

Étiquetage 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

dispositif médical 

  • MD class : IIa
  • MD notified body : CE0197
  • EU directive/regulation : Directive 93/42/CEE
  • annexe : V

stérile 

  • stérile : yes
  • sterilization method : ethylene oxide

conformité 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.

Informations
logistiques

Conditions de transport 

Protected from light, humidity and heat

Conditionnement Quantités de pièces Dimensions en cm Poids en kg Ean 13 du conditionnement
UNIT 1 06972620110671
CASE 200 49 x 58 x 42 16972620110678

The sterile, DEHP-free INFINEED 3-way infusion set with 2 stopcocks has been designed to minimize its environmental impact, using only DEHP-free raw materials (eliminating components containing DEHP). The polycarbonate-free 3-way stopcocks have been tested at pressures well in excess of those recommended for gravity perfusion; laboratory tests have shown a pressure resistance of around 10 bar.

Perforator available:
- Perforator: Bicanal with gripping wings.
- Air intake: Supplied closed for immediate use on bag (except for infusers with non-return valve) - 1.2µ filter.
- Chamber: Flexible and translucent, the chamber is calibrated to 20 drops = 1ml ± 0.1ml. 15µ anti-particle filter.
- Wheel: Precise and reliable, linear flow regulator.
- Tubing: PVC, DEHP-free, designed for even adjustment. Tube diameter: 3 x 4.1mm.
- End cap: Luer Lock mobile.
- End cap: 0.8 µm purge filter with hydrophobic antibacterial membrane.
- Bisphenol A-free 3V valves.
- Polycarbonate and silicone non-return valve.
Tube dead volume: 15.90ml.
Chamber dead volume: 5.10ml.

Made in China.

Indications 
This device enables gravity administration of injectable parenteral preparations: drugs, solutions, parenteral nutrition when the use of two 3-way valves is required (anesthesia, obstetrics). For peripheral lines, the infusion line can remain in place for a maximum of 96 hours (i.e., the maximum duration of peripheral catheter insertion). For central lines, the infusion line must be changed at least every 72 hours (or according to the institution's validated protocol). To disinfect connections, use 70° alcohol, which is highly compatible. Caregivers are increasingly using chlorhexidine 2% in 70% isopropyl alcohol. This type of solution is known to be very aggressive to plastics. For this reason, Didactic conducted laboratory tests on the contact of connections with this type of disinfectant. The results showed that the connections were fairly resistant to this composition when in relatively short contact (less than 1min) with a swab soaked in disinfectant solution without excess (1 to 2ml per swab). Gravity infuser, not to be used for pressurized infusion, notably injection of contrast media. Not to be used for transfusions, or for drugs requiring a 0.2µm filter.

Matériaux utilisés 
PVC: Chamber, air intake, DEHP-free tubing. Polyethylene: Purge filter, cap, perforator protector. Acrylonitrile Butadiene Styrene: perforator, mobile Luer Lock, linear flow regulator. Nylon: Particle filter. PC: Non-return valve. Polypropylene: Protective tap caps. High density polyethylene HDPE: Faucet key. BPA-free Tritan ® copolymer: Faucet body. Silicone: Lubricant, tap, non-return valve.

Étiquetage 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

dispositif médical 

  • MD class : IIa
  • MD notified body : CE0197
  • EU directive/regulation : Directive 93/42/CEE
  • annexe : V

stérile 

  • stérile : yes
  • sterilization method : ethylene oxide

conformité 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Infusion equipment for medical use - Part 4 : Infusion sets for single use, gravity feed.

Conditions de transport 

Protected from light, humidity and heat

Conditionnement Quantités de pièces Dimensions en cm Poids en kg Ean 13 du conditionnement
UNIT 1 06972620110671
CASE 200 49 x 58 x 42 16972620110678

Produits associés

STERILE PVC 3-WAY INFUSION SET WITHOUT DEHP 3X4,1 1 3-WAY TAP WITH BLUE LUER LOCK MOBILE NON-RETURN VALVE FILTER DRAIN 235CM

Produits associés

STERILE PVC 3-WAY INFUSION SET WITHOUT DEHP 3X4,1 1 3-WAY TAP WITH BLUE LUER LOCK MOBILE NON-RETURN VALVE FILTER DRAIN 235CM

Request for technical documentation

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