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The DEHP-free, BPA-free INFINEED lt;Gravity lt; 1-way infusion set was designed to minimize 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).
Two-channel perforator
Air intake: Delivered closed for immediate use on a 0.2µm filter bag, Chamber: Chamber: 5.5 mL / 5 cm long - Flexible and transparent, Calibrated at 20 drops = 1ml ± 0.1ml. With 15µm 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.
End fitting: Mobile Luer Lock, end stopper equipped with a purge filter with anti-bacterial membrane. Very pressure-resistant purge filter.
Length: 160cm
Residual volume: 15ml
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.
Gravity infusion set, do not use for pressure infusion, transfusion or medicine that need a 0.2µm filter.
Dispose according to the state member regulation.
Used materials
PVC (DEHP < 01.% (m/m)): Chamber, air intake, tubing - DINCH: plasticizer - HDPE: protective perforator cap, end cap - Acrylonitrile Butadiene Styrene: Perforator, linear flow regulator, roller, mobile Luer Lock - Polyamide: Particle filter - Polyethylene/PTFE: Purge 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 | 21 x 10 x 1 | 0.029 | 3661809028939 |
BAG | 25 | 48 x 27 x 4 | 0.660 | 3661809128936 |
CASE | 250 | 59 x 39 x 27 | 7.624 | 3661809228933 |
PALLET | 6000 |