STERILE INFUSION SET PVC DEHP-FREE BPA-FREE 3X4.1 - 1 WAY Y-SITE MOBILE LUER LOCK VENT FILTER 190 CM

Reference : PER1YFL25

  • Bisphenol A and DEHP free (<0.1% m/m.)
  • Designed to minimise the environmental footprint by reducing the weight of plastic materials.
  • Packaging developed with users to provide excellent readability of the main information needed immediately.

Description

The DEHP-free, BPA-free INFINEED lt;Gravity lt; 1-way infusion set has been designed to minimise the device's environmental impact. Two methods have been used: first, by reducing the plastic mass used by around 10%, without making any changes to functionality; second, by exclusively using raw materials that are free from endocrine disruptors (elimination of components comprising DEHP or BPA.)

The Y-site enables the bypass delivery of bolus drugs using a syringe and needle.

Infuser with:
- Two-channel perforator
- Air intake: Delivered closed for immediate use on a 0.2µ filter bag
- Chamber: 5.5 mL / 5 cm long - Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, 15µ particle filter.
- Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.
- Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks.
- Latex-free Y-site made from synthetic polyisoprene
- End fitting: Mobile Luer Lock, 
- End stopper equipped with a purge filter with anti-bacterial membrane of 0.8µm. Very pressure-resistant purge filter.

Length: 160cm

Residual volume: 16.5 ml

Made in China



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

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

Technical
information

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Dispose according to legislation in member state.

Used materials 
PVC (DEHP< 01.% (m/>)): Chamber, air intake, tubing - DINCH: plasticiser - Polyethylene: Purge filter, protective cap for perforator, mobile Luer Lock - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator - Polyamide: Particle filter - Injection site: ABS + synthetic polyisoprene

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 : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

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
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • 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.

economic operator 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

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 21 x 10 x 1 3661809029349
BOX 25 3661809129346
CASE 250 59 x 39 x 27 3661809329340
PALLET 6000

The DEHP-free, BPA-free INFINEED lt;Gravity lt; 1-way infusion set has been designed to minimise the device's environmental impact. Two methods have been used: first, by reducing the plastic mass used by around 10%, without making any changes to functionality; second, by exclusively using raw materials that are free from endocrine disruptors (elimination of components comprising DEHP or BPA.)

The Y-site enables the bypass delivery of bolus drugs using a syringe and needle.

Infuser with:
- Two-channel perforator
- Air intake: Delivered closed for immediate use on a 0.2µ filter bag
- Chamber: 5.5 mL / 5 cm long - Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, 15µ particle filter.
- Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.
- Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks.
- Latex-free Y-site made from synthetic polyisoprene
- End fitting: Mobile Luer Lock, 
- End stopper equipped with a purge filter with anti-bacterial membrane of 0.8µm. Very pressure-resistant purge filter.

Length: 160cm

Residual volume: 16.5 ml

Made in China



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

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

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. According to good perfusion practice, the infusion line can remain in place for up to 96 hours (CODIMS, OMEDIT CENTRE-VAL-DE-LOIRE, Socle de connaissance de la perfusion - SFAR, EUROPHARMAT, [...]). In addition, the SF2H reminds us not to change the main infusion line before 4 days, without exceeding 7 days. This device has been tested for pressure, traction and lipid resistance for up to 7 days. The length of time the infusion line should be maintained should be discussed and validated in each facility, in order to establish an internal protocol. Dispose according to legislation in member state.

Used materials 
PVC (DEHP< 01.% (m/>)): Chamber, air intake, tubing - DINCH: plasticiser - Polyethylene: Purge filter, protective cap for perforator, mobile Luer Lock - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator - Polyamide: Particle filter - Injection site: ABS + synthetic polyisoprene

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 : 1370
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : II

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
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • 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.

economic operator 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 21 x 10 x 1 3661809029349
BOX 25 3661809129346
CASE 250 59 x 39 x 27 3661809329340
PALLET 6000

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