Fresenius Medical Care AquaA, Instructions For Use Manual

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Chapter 2: Important information
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 17
2.5 Brief description
The device reflects the latest state of technology. It is equipped with all
safety systems required for its function and for patient safety. It
complies with the requirements of ANSI/AAMI ES60601-1.
The AquaA is a reverse osmosis system which can be extended by the
responsible organization with additional components to a complete,
double pass system for the production and supply of dialysis water.
The reverse osmosis system produces highly deionized water, also
called dialysis water.
If necessary, additional modules can be connected downstream for
improved quality. The dialysis water can be used for dialysis treatments
or for the production of concentrates.
2.5.1 Indications for Use
The AquaA water purification system is a modular reverse osmosis unit
intended for use with hemodialysis systems to remove organic and
inorganic substances and microbial contaminants from the water used
for treating hemodialysis patients or related therapies. This device is
intended to be a component in a complete water purification system and
is not a complete water treatment system. The reverse osmosis unit
must be preceded by pre-treatment devices and may need to be
followed by post-treatment devices as well, to meet current
AAMI/ANSI/ISO and Federal (U.S.) standards.
Caution:
Federal law restricts this device to sale by or on the order of a physician.