INFUSION SET ST 1 WAY ROT FLOW CONTROLLER GRADUATED BPAF

Reference : PER1FLPFP

  • 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 1-way infusion set "Gravity 5.5" with rotary flow controller 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.)

For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.
For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.
The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).

Infuser with:

Two-channel perforator with grip wings.

Air intake: Delivered closed for immediate use on a 0.2µ filter bag.

Chamber: Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, 15µ particle filter.

Tubing: PVC (DINCH or TOTM) designed for comfort, optimal flow adjustment consistency and to avoid kinking.

End stopper: Mobile Luer Lock equipped with a purge filter with anti-bacterial membrane.

Technical
information

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. Do not use with high-risk drugs, drugs with a narrow therapeutic range (catecholamines, morphine, heparin, insulin, potassium chloride, anticancer drugs requiring administration by infusion pump, and all pharmaceutical specialties which include in the SPC the need for administration by infusion pump or syringe pump. ) For peripheral lines, the infusion line can remain in place for a maximum of 96 hours (i.e. the maximum time the peripheral catheter can be in place). For central lines, the infusion line must be changed at least every 72 hours (or according to the institution's validated protocol). Source: OMEDIT CENTRE -- Best practices for infusion:"Infusion flow accuracy" module.

Used materials 
PVC: Chamber, air intake, tubing - Polyethylene: cap with purge filter, protective cap for perforator - Acrylonitrile Butadiene Styrene: rotary flow regulator, infusion set, Mobile Luer Lock, fixed Luer Lock tip - Nylon: Particle filter

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
  • 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 0.032 3661809032820
BOX 100 32 x 38 x 28 3.740 3661809032837
CASE 400 66 x 59 x 39 15.000 3661809032844

The DEHP-free, BPA-free INFINEED 1-way infusion set "Gravity 5.5" with rotary flow controller 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.)

For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.
For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.
The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).

Infuser with:

Two-channel perforator with grip wings.

Air intake: Delivered closed for immediate use on a 0.2µ filter bag.

Chamber: Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml, 15µ particle filter.

Tubing: PVC (DINCH or TOTM) designed for comfort, optimal flow adjustment consistency and to avoid kinking.

End stopper: Mobile Luer Lock equipped with a purge filter with anti-bacterial membrane.

Indications 
This device enables the parenteral administration by gravity of injectable preparations: parenteral drugs, solutions and nutrition. Do not use with high-risk drugs, drugs with a narrow therapeutic range (catecholamines, morphine, heparin, insulin, potassium chloride, anticancer drugs requiring administration by infusion pump, and all pharmaceutical specialties which include in the SPC the need for administration by infusion pump or syringe pump. ) For peripheral lines, the infusion line can remain in place for a maximum of 96 hours (i.e. the maximum time the peripheral catheter can be in place). For central lines, the infusion line must be changed at least every 72 hours (or according to the institution's validated protocol). Source: OMEDIT CENTRE -- Best practices for infusion:"Infusion flow accuracy" module.

Used materials 
PVC: Chamber, air intake, tubing - Polyethylene: cap with purge filter, protective cap for perforator - Acrylonitrile Butadiene Styrene: rotary flow regulator, infusion set, Mobile Luer Lock, fixed Luer Lock tip - Nylon: Particle filter

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
  • 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 0.032 3661809032820
BOX 100 32 x 38 x 28 3.740 3661809032837
CASE 400 66 x 59 x 39 15.000 3661809032844

Request for technical documentation

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