Area of application and intended use
Part 1 • Page 2-1
Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
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 equipment supplied can only be maintained when the machine is used
as intended.
The values given in the technical data
part 2, chapter 7, must be observed. Limit values must never
be exceeded.
The amount of free chlorine must not exceed 0.0 ppm, the amount of iron (Fe) must not exceed 0.1 ppm.
The hourly performance (in litres) of the system is between 700 and 3600 l/h (3–10 gph), depending on the
system/type. The temperature of the incoming water must not drop below 6°C / 42.8°F. The device has
been designed for continuous operation.
In support of intended use, the manufacturer prescribes an annual technical safety check (STK) by
authorized skilled personnel (
The permeate is not suitable as drinking water.
WARNING
Misuse or improper operation of this device will void any warranty.
NOTICE
EcoRO Dia I/II (HT) is a device that is intended for use with a hemodialysis system and that
is intended to remove organic and inorganic substances and microbial contaminants from
water used to dilute dialysate concentrate to form dialysate. This device may include a water
softener, sediment filter, and carbon filter.
a
a. It is the task of the responsible dialysis physician to select suitable water preparation systems for dialysis.
When it is used for its specific purpose, the system produces “water for diluting hemodialysis concentrate” in accordance with the
stipulations laid down in the CSA-Z23500-12/AAMI/ANSI/ISO 23500:2011.
The reverse osmosis system is used for the production of permeate to dilute hemodialysis concentrates.
IMPORTANT The quality of the feed water upstream of the pretreatment must comply with the require-
ments of EPA “National Primary Drinking Water Regulation” (2009) of drinking water. For
LMW-specific deviations from or supplements to the guideline, see
NOTICE
During intended use, the minimum salt retention is 90%, based on the raw water
conductivity.
NOTICE
The devices of the EcoRO Dia I/II (HT) 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 7.14 “EMC guidelines”.
Portable and mobile high-frequency communication equipment can influence electrical
medical devices.
The devices of the EcoRO Dia I/II (HT) series may not be used if they are located immediately
next to or stacked on top of other devices. However, if this is required, the devices must be
observed to check for intended use in this arrangement.
a
a. 1. AAMI/ANSI/ISO 23500:2011 Guidance for the preparation and quality management of fluids for hemodialysis
and related therapies
2. CSA-Z23500-12 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
3. AAMI/ANSI/ISO 13959:2009 Water for hemodialysis and related therapies
WARNING
Misuse or improper operation of this system could result in serious injury, death, or other
serious reactions to a patient undergoing hemodialysis treatment.