Part 1 – Operating Instructions
Rev. 4.00 December 2014
Software version 1.04
EcoRO Dia I/II (HT)
Part 1
General Warnings, Important, Notice
WARNING
Before you start using this system, you must read and understand this manual in its entirety.
These operating instructions describes in considerable detail all of the steps and proce-
dures required to safely operate this system.
WARNING
It is unsafe to operate this system without a basic understanding of water treatment and
a thorough understanding of the contents of this operating instruction.
WARNING
The selection of water treatment equipment for dialysis is the responsibility of the dialysis
physician. Product water must be tested periodically according to the AAMI/ISO 13959:2009
standard.
WARNING
Improper operation of this device could result in a low or no-flow alarm on the hemodialysis
machine.
WARNING
Never operate the water treatment system on microbiologically unsafe water supplies,
deionized water, or RO water. Use of another water supply other than properly treated
municipal water supplies may result in biological contamination of the entire RO flow path
or improper reading on water quality monitor.
WARNING
Misuse or improper operation of this device will void any warranty.
WARNING
Circumventing warnings and safety features of the device as well as misuse or improper
operation of this system could result in serious injury, death, or other serious reactions to
a patient undergoing hemodialysis treatment.
WARNING
Misuse, unintended use or handling of chemical disinfectants and chemical cleaning solu-
tions could result in serious unjury or even death. You must comply with the information
contained in the Material Safety Data Sheet (MSDS) see also part 1 for the chemical being
used and follow the procedural steps in these operating instructions.
WARNING
While a water treatment system may produce water of sufficient quality to meet the require-
ments of AAMI/ISO 23500:2009 standard, distribution of the water may degrade its quality to
the point where it no longer meets the requirements of the standard if the distribution sys-
tems is not maintained appropriately.
WARNING
The maintenance of the equipment following its installation is the responsibility of the
dialysis physician. Product water should be tested periodically.