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The INFINEED lt;Gravity lt; 3-ways infusion set without DEHP, BPA-free was designed to minimize the environmental impact of the device. 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 polycarbonate-free 3-way stopcock has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bar.
Infusion set with:
- Two-channel perforator with grip wings
- Air intake: with 0.2µm filter. Delivered closed for immediate use on infusion bags.
- Chamber: Soft and translucent, the chamber is calibrated at 20 drops = 1ml ± 0.1ml. 15µ particle filter.
- Flow regulator: ABS linear flow control for good roller clamp rigidity, precision and reliability.
- BPA-free 3-way stopcock: Lipid-resistant with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube. Only the main line can be disconnected from the stopcock.
- Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 3 x 4.1mm
- End connector: Mobile Luer Lock
- End stopper: 0.8 µm purge filter with hydrophobic membrane
Length: 170cm + 10cm
Residual volume: 15.4 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 regulation in member state.
Used materials
PVC DINCH (DEHP<0.1%(m/>)): Chamber, air intake, tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Tritan® BPA-free: Stopcock body - Acrylonitrile butadiene styrene: Perforator, regulator, mobile Luer Lock - 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
sterile
conformity
economic operator
Transport conditions
Protect from light and humidity and store at a temperature between 5°C and 20°C.
Conditioning | Parts quantities | Dimensions in cm | Weight in kg | Ean 13 of conditioning |
UNIT | 1 | 10 x 25 x 1 | 0.030 | 3661809029387 |
BAG | 25 | 48 x 29 x 6 | 0.810 | 3661809129384 |
CASE | 250 | 58 x 40 x 25 | 7.850 | 3661809229381 |