Microsoft word - in018000eng

PRODUCT CODE IN018000
INFUSION SET FOR USE WITH PVC
INCOMPATIBLE COMPOUNDS AND WITH
STERILIZING I.V. SOLUTION FILTER 0.2
INFUSION SET COMPOSED OF:
1.1 Technical characteristics of the I.V. set:
• Protective cap: Maintains the sterility of the fluid path.
• Closure Piercing Device: The special design of the spike
enables easy penetration of bottle and plastic bag closures • Air Inlet: With bacterial air filter and attached airway
• Drip Chamber: The flexible drip chamber can be quickly
and easily filled and the fluid set to the level at the ring mark. The transparent non reflective material, of which it is made, makes control of the adjusted flow rate very easy. Standard drop rate 20 drops water = 1 ml. ± 0.1 ml. • Flow Regulator: Patented precision roller clamp enables
exact adjustment of the desired flow rate and holds it there • Tubing: Transparent PVC D.E.H.P. FREE tubing, i.d. 3.0
• Injection site: “Y” injection port, produced in isoprene
“LATEX FREE”, permits a secure additional medication. • Needle adapter : Male Luer- Lock adapter guarantees a
secure connection to the venipuncture device ( I.V. catheter CLASS: I Sterile
• Packaging: device packaged in sterile single blister. Box
STERILIZING I.V. SOLUTION FILTER:
To use in the I.V. therapy. This filter is indicated for i.v. administration solutions. It offers the possibility to maximise
Manufactured by
the use of I.V. set, and offers to the patient more protection ARIES S.r.l.
from associates risks, than the standard I.V. set. Removes Via XXV Luglio, 43 - 41037 Mirandola (MO) Italy microbial, particulate and air contamination. This filter with 0.2
The infusion set has been studied to allow the infusion of all PVC incompatible compounds through
constantly dosages without drug’s lost. The device is produced in PVC without phthalate (DEHP) being
plastified with TOTM (tri-2 etilesil-trimellitato), a primary plasticizer with high molecular weight, indicated
for use with bags for blood preservation, dialysis tubing, catheters, extension set and other medical devices.
These I.V. sets could be utilised with all "PVC incompatible compounds", such as Chlorpromazine HCL,
Chlormethiazole, Diazepam, Dopamine HCL, Hydralazine, Isosorbide bi-nitrate, Promazine HCL,
Promethazine HCL, Pyridoxine HCL, Taxol, Theophyilline, Thiofluorperazine, Thiopental sodium,
Thioridazine HCL etc.
The in line 0.2 micron filter makes the set particularly indicated for administration of “TAXOL” and for all
those antineoplastic drugs for administration of which is necessary a set with similar characteristics to this one.
1.2 Technical characteristics of the filter:
• Maximum operating pressure 45 PSI (3.1 bar) • Air vented, to prevent filter blocks. • Several filling possibility. • Priming volume: 2.4 ml. • Effective filtration area: 10 cm² • Water bubble point: 3.1- 3.7 bar • Minimum water flow rate: > 20 mL/min. at 91 cm. MATERIALS:
• Filter Media: Supor (polyethersulfone) membrane 0,2 micron.
• Housing: modified acrylic
• Support: polyester
• Biocompatibility: construction materials pass USP class VI-121° C plastic, hemolysis and cytotoxicity
Staytime: according to needs of medical staff.
Tests:
Each component is tested with a dimensional and visual test to verify the conformity to the internal QA
parameters. On the finished products, before of the sterilization, are conducted visual tests, dimensional,
physical flowing and sealing. The sampling plan are studied according to UNI ISO 2859-1. On the finished
products are conducted sterility tests, apirogenicity, biocompatibility and toxic according to ISO 10993.
Infusional liquids compatibility: biological liquids compatible, blood and emoderivates, all organic and
non-organic solutions.
Production and conformity:
This device is produced following the GMP. Moreover ARIES has build up a Quality System
according to UNI EN ISO 9001: 2000 e UNI CEI EN ISO 13485: 2004. This device is
conform to the directive 93/42/CEE and it’s biocompatible according to ISO 10993. Materials
used are of medical grade and components are produced according to ISO 594/1-2. Corr.
ed.,E.P.Corr. ed.
Stocking: temperature from +5°C, up to +40°C.
Sterilisation:
ETO resistant. Expiry date 5 years from sterilisation date. Residue gas according to F.UI Corr. Ed.and
F.E.Corr. Ed (10 ppm).

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