Fresenius Medical Care AquaA, Инструкция по эксплуатации

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Chapter 15: Appendix
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 233

Chemical quality of dialysis water
Recommended chemical
surveillance
Annual inspection The dialysis water should be checked for chemical contamination at
least once a year.
Offline tests If the feed water or pretreated water is chlorinated and offline tests are
used, the total chlorine test should be performed downstream of the
activated carbon filter at the beginning of each treatment day, before the
first patient treatment. If chloramine is used at a concentration of 1 mg/L
or more to disinfect the drinking water supply, the test should be
repeated before the start of each patient session. If no patient sessions
are scheduled, the test should be carried out approximately every
4 hours during operation.
ISO 23500-3 (or ISO 13959 respectively)
Contaminants
with proven
toxicity in
dialysis
Maximum
allowable level
[mg/L] Electrolytes Maximum
allowable level
[mg/L] Trace elements Maximum
allowable level
[mg/L]
Aluminum 0.01 Calcium 2 Antimony 0.006
Lead 0.005 Potassium 8 (*2) Arsenic 0.005
Fluoride 0.2 Magnesium 4 (*2) Barium 0.1
Total chlorine 0.1 Sodium 70 (*50) Beryllium 0.0004
Copper 0.1 Cadmium 0.001
Nitrate as (N)* 2 Chrome 0.014
Sulfate 100 (*50) Mercury 0.0002 (*0.001)
Zinc 0.1 Selenium 0.09
Silver 0.005
Thallium 0.002
* Values according to the European Pharmacopoeia (Ph. Eur.); applicable regulations must be observed. Other
deviations in Ph.Eur. are: nitrate: limit value = 2 mg/L nitrate in relation to the total nitrate molecule NO
3
. Other
contaminants listed only in the Ph.Eur. are: ammonium (NH
4
): 0.2 mg/L; heavy metals (such as Pb): 0.1 mg/L;
chlorides: 50 mg/L.
For continued compliance with quality standards, checks and disinfections of the dialysis water system must be
performed regularly.