Fresenius Medical Care AquaA, Instructions For Use Manual

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Chapter 2: Important information
18 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
2.6 Intended purpose and related definitions
2.6.1 Intended purpose
Production of dialysis water for dialysis treatments
2.6.2 Medical indication
Renal insufficiency requiring renal replacement therapy, supported by
a reverse osmosis system for the treatment of water.
2.6.3 Intended patient population
The AquaA has no clinical effect on its own. The device only supplies
purified product water as dialysis water, which is required for the
production of standard dialysates. There are therefore no restrictions
regarding the intended patient population. The intended patient
population is defined by the hemodialysis device.
2.6.4 Intended user group and intended environment
The device must only be installed, operated, and used by individuals
with the appropriate training, knowledge, and experience, and who are
certified to have been trained.
The device must be operated in rooms that are suitable for operating
reverse osmosis systems and which are located in professional health
care establishments.
2.7 Side effects
As dialysis water has no direct clinical effect, there are no side effects
that can be attributed solely to the use of dialysis water. Dialysis water
is always used in combination with a hemodialysis treatment. Increased
calcium, magnesium, and iron content in dialysis water can cause hard-
water syndrome, resulting in nausea, vomiting, weakness, and/or high
blood pressure.
The following list contains known side effects related to hemodialysis
treatment according to current literature: