INFUSION SETS DΕF2ΒLL 1,5Μ LUER LOCK POLY BAG

Infusion Sets Def2Βll 1,5Μ Rays

Commercial name: Infusion Set
Order Code : DEF2BLL
Purpose of Use : Disposable infusion administration solution with luer lock. (invasive and short-term dispositive)
Description : Infusion set composed of:
ABS spike with air vent, 0.45 micron filter with polyethylene cap.
Chamber in PVC by 6.2 cm with 15 micron.
PVC tube length is cm 150 con external diameter and internal 4,1x 3 mm
ABS roller
Injection site is latex free.
Phthalate free
PVC luer lock cone without needle and with polyethylene cap.
Packaging: Single packaging in polybag –20 infusion sets in large polyethylene envelopes - 18 boxes of 20 infusion sets ( 360 units per carton)
Sterilization Method: Sterilized by Ethylene Oxide (EtO) Residual gas according to the applicable regulations.
Sterilization Validity 5 years.
Particular Contamination: Infusion set code DEF2BLL is produced in special conditions that minimize the contamination
Integrity : Infusion set cod. DEF2BLL does not show any sign of infiltration of air when immersed with the closed cone, inside the water with temperature of 20°C to 30 °C and with an internal pressure of air by 20 Kpa under the atmospheric pressure for 10s.
Connections between : Any connection between the components of the infusion set, excluding the protective caps, must maintain
Components a static tensile strength not inferior than 15 N for 15s.
Spike : The dimensions of the spike correspond the requires of ISO 8536-4:1997(E).
Air vent: The device for the air intake has a filter per air which prevents the entry of the micro-organisms within the container where the infusion tube was inserted. When the infusion tube is inserted into a rigid container for infusion, the air filled inside the container will not go in to the spurted liquid. The Air vent is placed in a way that all the air entering in to the rigid container passes through itself. The flow of the liquid is not reduced more than 20% of that freely ventilated container.
Tube: The tube is made with Medical grade PVC, sufficiently transparent and clear enough in order to observe the flow of the physiological solutions and the air bubbles. The length of the tube is 150 cm and including the injection site and the luer lock cone.
Dripper: The dripper in the chamber permits a continuous observation for the drop falls. The liquid enters in the chamber through a tube that reaches to the chamber. There is a distance not less than 40 mm between the end of the dripper tube and the base of the chamber. The dripper tube is such that 20 or 60 drops of
distilled water( 23°C+2°C) with the flow of 50 drops min. + 10 drops min. generate a volume of 1 ml +0.1 ml (1 g +0.1 g).
Flow Regulator: The Flow regulator regulates the flow of the solution between zero and the maximum. The Flow regulator could be used continuously during an infusion and without damaging the tube.
The injection site: After perforating a hypodermic needle with an outer diameter of 0.6 mm to the self sealant injection and having held the needle in position for 15s, it closes and the ,maximum loss is a drop of water.
Protective caps: The protective caps maintain sterility of the spike, the luer-lock connector and the interior of the infusion set.
Latex -free: Infusion set code DEF2BLL and the relevant packaging are completely latex-free.
Compatibility to pharmaceuticals: This product is not intended to interact with the substances that they contact with, therefore the incompatibility episodes with disinfectants, infusion solutions , biological materials etc. are not known.
They are not explicitly considered incompatible with the constituent materials of the product for incompatible pharmaceuticals with PVC and for the light-sensitive solutions exist specific products.
Conservation: Store in a cool dry place and far away from the any source of heat at a temperature between 5° C and 40°C
Disposal: Disposal must be made in accordance with the applicable government regulations. Incineration or landfill disposal must be carried out under controlled conditions. The product that didn’t come in to contact with infectious agents or other hazardous materials do not produce toxic residue.
Certificate EC: EC Certificate n. MED 29041-A issued by Notified Body n. 0476 - Cermet Scarl and is released to Rays S.p.A. on 01/05/2010 and valid till 30/04/2020 in conformity with the requirements of Directive EEC 93/42
as per attached V.
Classification: The Legislative Decree 46/97 on Medical Devices classify to the purpose of EC marking that product belongs to IIa class.