Fresenius Medical Care AquaA, Instructions For Use Manual

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Chapter 2: Important information
22 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
Use only original spare parts. To identify and order spare parts, test
equipment, and tools, always use the electronic spare parts catalog.
Transport and storage (see chapter 10 on page 153)
2.13 Expected service life
The expected service life is 10 years.
2.14 Duties of the responsible organization
The responsible organization must ensure
– compliance with the national or local regulations concerning the
installation, operation, use, and maintenance of the device.
– compliance with the accident prevention regulations.
– correct and safe condition of the device.
– making the Instructions for Use available at all times.
2.14.1 Further aspects of the responsible organization
– The device is a system for the production of dialysis water for
dialysis treatments which can be extended by the responsible
organization with additional components to form a complete water
treatment system. The system must be installed in a dry room which
is not used for medical procedures. A staff call feature should also
be enabled.
– The responsible organization must ensure that the technical design
of the system matches the requirements of the other components
used to make up the complete system.
– The reverse osmosis system must be easily accessible from all
sides. The responsible organization must prepare a plan for
emergency operation to supply dialysis devices with dialysis water
based on the available system components and must make this plan
available to the operators of the system.
– The responsible organization must ensure that its operators have
been trained. Operators of the reverse osmosis system and the
dialysis devices must have received instructions on how to operate
the system.
– The responsible organization should inform the local water supplier
of the dialysis operation and insist on prior discussion with regards
to water composition, availability, etc. This measure does not relieve
the responsible organization of its obligation to regularly check the
inlet water composition.