Gambro AK 96, Operator'S Manual, Page: 200 / 509

Hygiene - Heat Disinfection
Heat Disinfection - General
During the heat disinfection program the inlet water is heated up
and fl ushed through the fl uid monitor. The program begins with a
rinse in order to eradicate possible residues from concentrates used
in the preceding treatment. After this, the program consists of three
consecutive phases; the fi llup phase, the circulation phase and the drain
phase. The actual disinfection takes place in the circulation phase. The
circulation phase consists of a number of cycles, where each cycle is
a sequence in which heated water is passed through all parts of the
fl uid path. The standard heat disinfection program consists of 12
such cycles.
The AK 96 dialysis machine fl uid path is constructed in a way that
prevents possible contaminants in the post-dialyzer fl uid path from
reaching the patient. The construction principle is called single pass ,
which means no recirculation in the fl uid path, and a separation
between the pre-dialyzer circuit and the post-dialyzer circuit. This is to
ensure that no fl uid from the downstream (post) dialyzer circuit comes
into contact with the pre-dialyzer circuit. The construction principle
is an effective obstacle to transmission of blood-borne viruses like
Hepatitis B, from the fl uid path to the patient, if a blood leak in the
dialyzer occurs. In addition the standard heat disinfection program has
the capacity to make viruses inactive.
The combination of the standard heat disinfection program process
(12
cycles) and the safe hygienic construction of the fl uid path
(single pass) described above provides high safety levels for the patient.
The standard heat disinfection program is validated by using
microbiological challenge tests which gives a 5 log reduction of the
following microorganisms; Pseudomonas aeruginosa (ATCC 9027),
Staphylococcus aureus (ATCC 6538), Burkholderia cepacia (ATCC
17770) and Candida albicans (ATCC 10231).
The heat disinfection program can be extended for 22 cycles. The
22 cycles variant may be used in case of substantial contamination of
the fl uid path. This program provides different positions of the fl uid
path with at least 30% more heat. As a consequence, the duration of
this heat disinfection program will be extended by approximately 10
minutes, compared to the standard program.
It is possible to run a heat disinfection program in combination with
CleanCart cartridge:
•
Decalci fi cation program with CleanCart-C cartridge
•
Cleaning program with CleanCart-A cartridge
If heat disinfection program with CleanCart cartridge is chosen, the
contents of the CleanCart cartridge are dissolved and the solution
is heated-up and fl ushed through the fl uid monitor during the heat
disinfection program as described above. This program is extended
by a priming phase, a fi ll-up phase and a recirculation phase for the
HCEN12239 Revision 12.2010
Program version 3.xx
AK 96 ® Operator's Manual - Hygiene and Maintenance 8:9