Fresenius Medical Care AquaA, Instructions For Use Manual

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Chapter 12: Specifications
Fresenius Medical Care AquaA IFU-EN-US 06B-2021 169
12.8 Transport/storage
For further information (see chapter 10 on page 153)
12.9 External connection options
Other, additional equipment connected to this device must comply with
the applicable IEC or ISO standards (e.g., IEC 60950-1 for information
technology equipment).
Furthermore, all system configurations shall comply with the
requirements for medical systems (see Annex I to ANSI/AAMI
ES60601-1).
Connecting the device to an IT network that contains components not
installed and validated by the manufacturer can introduce unknown
risks for patients, operators or third parties. These risks must be
identified, analyzed, evaluated and monitored by the responsible
organization. For assistance, consult IEC 80001-1 and Annexes H5 and
H6 to ANSI/AAMI ES60601-1.
Any modification to an IT network that has been installed and validated
by the device manufacturer can introduce new risks and therefore
require a repeat analysis. Especially problematic activities include:
– Modifications to the IT network configuration
– Connection of additional components and devices to the IT network
– Removal of components and devices from the IT network
– Updates or upgrades of components and devices in the IT network
Note that local laws take priority over the above-mentioned
requirements. If in doubt, contact the local service department.

Device connections
Ethernet (TCP/IP) Interface for the exchange of data. Electrically isolated by transformer.
Port:
RJ45
Only systems complying with the regulations or IEC 60950-1 may be
connected to the LAN ports.
Feed flow FL–F 4.0 to 160.0 L/min ±10 %
Diversion FL–C 4.0 to 160.0 L/min ±10 %
*MV = measured value, actual value
Measured value Sensor Measuring
range Unit Accuracy