Permeate loop system of polyvinylidene fluoride (PVDF)
The material used for water treatment and permeat distribution in dialysis has an enormous impact on the microbiological and chemical quality of the dialysis.
With increasing quality standards in dialysis and under long-term point of view, only approved medical materials should be installed.
The MPG (Medical Devices Act) requires an admission of the permeate ring circuit in use with online dialysis machines. We have approved our loop system of PVDF as a Medical Device Class IIa - For you and the safety of your patients !
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Ring main systems of polyvinylidene fluoride (PVDF), bead and flush (BCF) welded to meet all requirements for water treatment systems with medical application:
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physiologically safe use of materials
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dead zones free connection technology
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hot water sanitization up to 140°C
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resistant to cleaning chemicals
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free of corrosion
Tests and certificates of PVDF:
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FDA (Food and Drug Administration)
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USP Class VI (Toxicity tests)
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DiBt (German Institute for Building Technology)
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KtW (Examination of the German Institute of Hygiene )
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Phoenix Multi-Loop-System
The dead zone-free solution with double-ring line to the dialysis machine
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Permeate loop system of polyvinylidene fluoride PVDF
approved by Phoenix Pure Water as a Medical Device Class IIa
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Permeate ring line used for the passage of clean water in connection with online dialysis units (Class IIb). Thus belong the permeate loop system (according to definition in Annex IX of MDD classification section 1.2, rule 2) of Class IIa.
Annex IX to the MPG section III. Classification
Section 1.2, rule 2:
All non-invasive devices for channeling or storing blood, other body fluids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class II a ,
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combined with an active medical device in class IIa or a higher class
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when used for storage or transmission of blood or other body fluids, or for storing organs, parts of organs or body tissues
CE Declaration of Conformity permeate ring line system of PVDF
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