Fresenius Medical Care 5008, Руководство по эксплуатации

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Chapter 11: System Description
Fresenius Medical Care 5008 OP 5/09.06 11-45
11.7.4 Water Supply – Additional Instructions to be Observed When Using the
DIASAFE
®
plus and the ONLINE plus ™
Dialysate quality The DIASAFE
®
plus removes bacteria and endotoxins from the
dialysate thus enabling the preparation of high-purity dialysate.
Microbiological quality
standards /
recommendations
General notes The microbiological purity of dialysate prepared in the dialysis center is
of critical importance.
Purified water quality The European Pharmacopoeia – 4th Edition lists maximum limits for
chemical and microbiological quality.
Modern reverse osmosis units and the appropriate design of water
storage and delivery systems (e.g. short distribution loops avoiding
stagnant flow zones) ensure compliance with this standard.
Concentrate quality Bicarbonate concentrate is an ideal nutrient medium for
microorganisms. The use of sterile or microorganism-poor concentrates
is recommended. Online dry concentrates (bi
b ag
®
) assist in the
preparation of dialysate with high microbiological quality. The use of
concentrate residues from open containers and the preparation of
bicarbonate concentrate in the dialysis center are
not recommended.
Central delivery systems for concentrate or dialysate must meet high
hygienic standards and demand regular inspection.
Caution
When using the DIASAFE
®
plus the following criteria must be observed
with regard to the quality of purified water, concentrate and dialysate:
– Use only reverse osmosis water.
– Always ensure that both purified water and dialysate meet the
applicable standard (see below).
For microbiologic quality standards / recommendations refer to the table
below.
Purified
water Concen-
trate Dialysate
(not
filtered) High-
purity
dialysate
Microbial
counts
(in CFU/ml) <100 <1000 <1000 <1
Endotoxins
(in I.U./ml) <0.25 <1 <1 <0.03
CFU: Colony-Forming Units
I.U.: International Units