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

Reference : PER3VF02

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

The non-return valve is a one-way valve which acts as a safety device (particularly when combining gravity and pressure infusion) by preventing any backflow of solution into the bag or vial. It has a pressure resistance of 3 bar in the patient-to-solute direction.





Perforator available:
- Perforator: Bicanal with gripping wings.
- Air intake: Supplied closed for immediate use on bag (except for infusers with non-return valve) - 0.5µm filter.
- Chamber: Flexible and translucent, the chamber is calibrated to 20 drops = 1ml ± 0.1ml. 15µm anti-particle filter.
- Wheel: Precise and reliable, linear flow regulator.
- Tubing: PVC, DEHP-free, designed for consistent adjustment. Tube diameter: 3 x 4.1mm.
- End cap: Luer Lock mobile.
- End cap: 1µm purge filter with antibacterial membrane.
- Bisphenol A-free 3V tap.
- Polycarbonate and silicone non-return valve.

Tube dead volume: 11.39ml.
Chamber dead volume: 3.52ml.

Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and with the luer lock connected, therefore under physical stress, presents a significant risk of luer lock cracking, and should be avoided wherever possible.



In line with SF2H (2019) recommendations, disinfecting connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective at disinfecting inert materials and with much less risk of altering plastics.





Technical
information

Indications 
This device enables gravity administration of injectable parenteral preparations such as drugs, solutions and parenteral nutrition. It is particularly recommended for mixed mechanical and gravity infusion: the non-return valve must be fitted to the gravity line. Gravity infusion set, not to be used for pressurized infusion, notably injection of contrast media. Not to be used for transfusion, not to be used for drugs requiring a 0.2µm filter. 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).

Used materials 
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.

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

medical device 

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

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • 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.

Logistics
information

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 06972620110923
CASE 200 49 x 58 x 35 16972620110920

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

The non-return valve is a one-way valve which acts as a safety device (particularly when combining gravity and pressure infusion) by preventing any backflow of solution into the bag or vial. It has a pressure resistance of 3 bar in the patient-to-solute direction.





Perforator available:
- Perforator: Bicanal with gripping wings.
- Air intake: Supplied closed for immediate use on bag (except for infusers with non-return valve) - 0.5µm filter.
- Chamber: Flexible and translucent, the chamber is calibrated to 20 drops = 1ml ± 0.1ml. 15µm anti-particle filter.
- Wheel: Precise and reliable, linear flow regulator.
- Tubing: PVC, DEHP-free, designed for consistent adjustment. Tube diameter: 3 x 4.1mm.
- End cap: Luer Lock mobile.
- End cap: 1µm purge filter with antibacterial membrane.
- Bisphenol A-free 3V tap.
- Polycarbonate and silicone non-return valve.

Tube dead volume: 11.39ml.
Chamber dead volume: 3.52ml.

Contact with 0.5% or 2% Chlorhexidine in 70° Isopropyl alcohol, without evaporation time, and with the luer lock connected, therefore under physical stress, presents a significant risk of luer lock cracking, and should be avoided wherever possible.



In line with SF2H (2019) recommendations, disinfecting connectors (when necessary) with 70° ethyl alcohol is always preferable, as it is just as effective at disinfecting inert materials and with much less risk of altering plastics.





Indications 
This device enables gravity administration of injectable parenteral preparations such as drugs, solutions and parenteral nutrition. It is particularly recommended for mixed mechanical and gravity infusion: the non-return valve must be fitted to the gravity line. Gravity infusion set, not to be used for pressurized infusion, notably injection of contrast media. Not to be used for transfusion, not to be used for drugs requiring a 0.2µm filter. 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).

Used materials 
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.

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

medical device 

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

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • 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.

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 06972620110923
CASE 200 49 x 58 x 35 16972620110920

Associated products

3-WAY INFUSER STERILE PVC WITHOUT DEHP 3X4.1 2 3-WAY VALVES 1 ANTI-RETURN VALVE LUER LOCK MOBILE PURGING FILTER 235CM

Associated products

3-WAY INFUSER STERILE PVC WITHOUT DEHP 3X4.1 2 3-WAY VALVES 1 ANTI-RETURN VALVE LUER LOCK MOBILE PURGING FILTER 235CM

Request for technical documentation

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