Operating instructions
ECOM
ix
1.4 Designated Use
The
ECOM
ix/
ECOC
art system is used for the fully automated preparation of an acid dialysis con-
centrate: In a closed, validated and verified process dry concentrate process is converted into a liquid
state. This treatment process, referred to herein for convenience as production, is the designated
application of this certified medical device.
The
ECOM
ix production system may only be used for the production of acidic dialysis concentrates
using the original
ECOC
art supplied by Intermedt. This allows dialysis concentrates to be produced
within the tolerances specified by ISO 23500-4. Other uses or applications, especially the use of other
media, may lead to dangerous situations and must absolutely be avoided. The
ECOM
ix/
ECOC
art
system is not intended for use in home dialysis.
Operation according to the designated use also includes observing safety instructions and operating
and maintenance activities prescribed by Intermedt.
Only use the system in a safe and microbiologically clean condition.
We only guarantee that we will manufacture to the ISO 23500-4 tolerances if an
original
ECOC
art is used and the manual is obeyed.
Microbiologically clean condition:
– Use of permeate according to the Ph. Eur. requirements
– Use of the flushing program
– Permeate has been in the mixing tank for less than 24 hours
– Sterile filters are used for aerating the tanks
– Drain equipped with a bacteria barrier to prevent retrograde contamination
– Original Intermedt media filter/observe replacement intervals
– Regular maintenance
– Only use permeate according to ISO 23500-3
– Monitor permeate according to ISO 23500-3 and current Ph.Eur.
Indication
The dialysis concentrates produced with the
ECOM
ix are suitable for hemodialysis and hemodiafil-
tration. The dialysis concentrate is for use with an alkaline bicarbonate hemodialysis concentrate
(NaHCO
3
) for a given dilution. The finished hemodialysis solution must be tested with a suitable
method before use. For safe use, refer to the manufacturer’s instructions for the hemodialysis ma-
chine. Acid and alkaline bicarbonate hemodialysis concentrate should only be diluted immediately
before use.
The following fields of application only apply to the ready-to-use hemodialysis solution, prepared
according to the information given on the
ECOC
art:
• Acute kidney failure
• Chronic kidney failure
• Overhydration
• Poisoning
• Correction of acid-base household and electrolyte status
16
State: April 2021
4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021