Rev. 6.4 dated 2022-02
Software Released Version: 1
Part 1 • Page 2-4
Area of application and intended use
Part 1 – Operating Instructions
(Eco)RO Dia II
Part 1 • Chapter 2
Note:
The Drinking Water Ordinance and the AAMI specify limit values for rare substances that are not listed here; these can be looked
up in the original publications. Compared to earlier publications of the Drinking Water Ordinance, the AAMI and the Ph. Eur., no
information regarding nitrogen and phosphate is provided. Compared to the guideline valid until now, the limit values were taken
from the guideline of the European Council of the EC and the DIN draft of 1987, the amended Drinking Water Ordinance
implements the values of the European Council, a new DIN draft is not known.
2.5
Contraindications and side effects
2.5.1
Contraindications
Do not use the reverse osmosis system if the chemical or microbiological quality of the raw water
is not clear.
Do not use the reverse osmosis system if the raw water does not satisfy the requirements of
guideline 98/83 EEC.
Do not use the reverse osmosis system if the freedom from disinfectant cannot be proved at all sampling
points after chemical disinfection before dialysis.
2.5.2
Side effects
Small amounts of aluminium and nitrate pass through the reverse osmosis membrane even if the reverse
osmosis system is used according to its intended use. Anaemia, neurological problems, cerebral diseases
and changes in bone structure have been observed in association with increased aluminium values in the
permeate. Nausea and vomiting as well as haemolysis have been observed in association with increased
nitrate amounts.
Particularly in the case of increased nitrate or aluminium values in the raw water, make sure that the
permeate satisfies the valid limit values for water to dilute concentrated haemodialysis solutions according
to Ph. Eur. 6.3 (2009):1167.
Biological parameters
Total germ count
[CFU/ml]
< 100 (22 °C)
< 20 (36 °C)
< 100 (22 °C)
< 20 (36 °C)
< 100 (17 –
23 °C, 168 h)
< 100 (30 –
35 °C, 5 days)
< 100 (22 ± 2 °C,
3 – 7 days)
Enterococci
0 CFU/100 ml
0 CFU/100 ml
E. coli/coliform
0 CFU/100 ml
0 CFU/100 ml
Pyrogenics
-.-
-.-
< 0.250 EU/ml
< 0.25 IU/ml
< 0.25 IU/ml
Definition/
Water quality
Drinking water
(water for
human use)
Feed water for reverse
osmosis Aquaboss
(Eco)RO Dia
Dialysis water / permeate / water for diluting
concentrated haemodialysis solutions
Directive
98/83/EC
98/83/EC + process
limit values
ISO 13959:
2009
European
Pharmacopoeia
7.0/2011:1167
Recommendation
by the Hygiene
work group