
You are:
The INFINEED lt;precision plus lt; 3-way DEHP free, BPA free PVC extension
has been designed to minimise its environmental impact, using only raw
materials that are free from endocrine disruptors (elimination of
components, including DEHP or BPA). The extension has been tested at
pressures well above those recommended for gravity infusion; laboratory
tests have shown a pressure resistance of approximately 10 bar.
BPA-free 3-way stopcock: Lipid-resistant (96 hours to 7 days) with
large valve stopcock and arrows indicating the direction of flow,
permanently attached to the extension tube.
- Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 2.5 x 4.1mm
- End cap: Mobile Luer Lock
- End stopper: 0.8 µm purge filter with hydrophobic membrane
Resistance to pressure of 2 bar according to the claim of compliance
with reference standard NF EN ISO 8536 -9, 10 bar according to tests
performed by Didactic (see scientific and technical file:
Lipid-resistant from 96 hours to 7 days)
Lipid resistant from 96 hours to 7 days
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 medical device is intended for the parenteral administration of injectable preparations (drugs, 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.
Used materials
PVC DINCH (DEHP<0.1%(m/>)): Tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Tritan® BPA-free: Stopcock body - Acrylonitrile butadiene styrene: Mobile male Luer Lock, fixed female Luer lock
Labeling
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable
medical device
sterile
conformity
economic operator