Area of application and intended use
Part 1 • Page 2-1
Part 1 – Operating Instructions
Rev. 6.4 dated 2022-02
Software Released Version: 1
(Eco)RO Dia II
Part 1 • Chapt
er 2
2.
Area of application and intended use
The operator is responsible for the intended use of the system.
The operational safety of the system supplied is only given when it is used as intended.
The values specified in the technical data
Part 2, chapter 7 must be observed. Limit values must never
be exceeded.
Intended use also includes adherence to the commissioning, usage and maintenance instructions pro-
vided by the manufacturer which are part of these operating instructions, as well as the consideration of
foreseeable misconduct.
During intended use the minimum salt retention is 95 %, based on the conductivity in the supply flow to the
reverse osmosis.
The hourly performance (in litres) of the system is between 2100 and 3600 l/h, depending on the system.
The temperature of the incoming water must not drop below 6 °C. The device has been designed for
continuous operation.
NOTE
The intended use is the production of water for diluting haemodialysis concentrates.
CAUTION
The
Aquaboss
®
reverse osmosis system may only be used for the intended purpose.
During intended use the device produces “water for diluting haemodialysis concentrates” in
accordance with the stipulations laid down in the European Pharmacopoeia (2011)
a
and
ISO 13959.
a
European Pharmacopoeia, edition 7.0/2011. 1167: “Aqua ad dilutionen solutionium concentratarum ad haemodialysim”
IMPORTANT The quality of the feed water upstream of the water softener (ion exchanger) must comply
with the requirements of EC guideline 98/83/EC of the Council dated November 3, 1998,
concerning the quality of water for human usage. For B. Braun-specific deviations from or
supplements to the guideline see
NOTE
Permeate is not suitable for drinking.
NOTE
During intended use the minimum salt retention is 95% based on the raw water conductivity.
NOTE
The devices of the (Eco)RO Dia II series are electrical medical devices that are subject to
special precautionary measures in terms of EMC; they must be installed and put into
operation according to the instructions in
Part 2, chapter 7, paragraph 7.11 “Command
Portable and mobile high-frequency communication equipment can influence electrical
medical devices.
The devices of the (Eco)RO Dia II series must not be used if they are located directly next to
or stacked on other devices. However, if this is required, the devices must be observed to
check for intended use in this arrangement.