Fresenius Medical Care AquaA, Instructions For Use Manual

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Chapter 2: Important information
20 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
2.9 Residual risks
Operating the device All instructions and operating steps in these Instructions for Use must
be carried out completely and conscientiously. The system may only be
operated by persons who have received the necessary training.
Use of non-specified
disinfectant Use only the agents described herein as disinfectants.
– Minncare
®
If other disinfectants are used, the desired disinfection effect and the
appropriate safety are no longer ensured.
Microbial contamination of
feed water The feed water must be of drinking water quality (in accordance with
local requirements). The Drinking Water Decree stipulates that the
water must be free from pathogens. In some countries, it is very difficult
to achieve this quality. We recommend that the water therefore be
checked continuously.
Checking the water inlet
quality The design of the water treatment system must ensure that the
necessary parameters are fulfilled. We recommend that the water inlet
quality be checked on a regular basis.
Tests for residual
disinfectant (after a
disinfection) Tests for residual disinfectant after a disinfection must be performed
conscientiously. Any mistakes present a severe hazard for the patient.
Microbiological
monitoring We strongly recommend that the entire device installation (in particular,
the dialysis water and dialysis water ring main) be monitored at regular
intervals with microbiological testing, and that appropriate cleaning and
disinfection procedures be carried out.
Contraindications There are no known contraindications. Contraindications may be
induced by the downstream form of treatment (hemodialysis).