Gambro AK 96, Operator'S Manual, Page: 21 / 509

Safety Philosophy
The AK 96 dialysis machine is designed according to the current
standards for hemodialysis equipment, IEC 60601-2-16. This means
that safety under so-called Single Fault Conditions is granted. In
practice this means that controllable treatment parameters (i.e.
conductivity, temperature and ultra fi ltration) are controlled by one
system, the control system , and monitored by another completely
separate protective system , utilizing its own sensors, electrical circuits
and microprocessors. The functionality of the protective system is
checked by the AK 96 dialysis machine before each treatment. A fault
detection during the pre-treatment tests will make it impossible to
start the treatment.
In order to verify that the corresponding control and protective systems
are operating with the correct input values, the user is instructed to
compare the readings from these systems before connecting to the
patient. Check that the calculated conductivity values (C/P) displayed
in the conductivity menu are in agreement. If this comparison is not
satisfactory, call an authorized technician.
The protective system will, when a parameter (measured by the
protective system) is outside the alarm limits, put the AK 96 dialysis
machine into a patient-safe condition. This means that the protective
system can stop the blood pump, close the venous clamp, prevent the
dialysis fl uid from reaching the dialyzer and alert the operator with
sound and light.
There is a risk that the blood of the patient may be contaminated
with bacteria and endotoxins due to transport of undesired substances
from the dialysis fl uid compartment to the blood compartment of the
dialyzer. This risk is reduced by using intact dialyzers, high inlet
water quality, high quality of concentrates and by using the optional
ultra fi lter for dialysis fl uid.
Ultrafiltration
For the ultra fi ltration control system, the transmembrane pressure
(TMP) is used as the protective system. Alarm limits for TMP related
to the dialyzer UF coef fi cient and the expected UF rate, are to be set
around the actual TMP value when starting treatment. The TMP alarm
limit correspond to a UF-deviation limit described by TMP
Alarm limit
x
UF
coef fi cient
. Example: If the alarm window is set to ±50 mmHg and
the UF-coef fi cient is 10 ml/mmHg x h the maximum weight deviations
without any alarm is ±500 g/h. Default the alarm window is set to
±100 mmHg. It is essential to ensure that the alarm window is set as
close as possible to the working TMP. As an additional precaution it is
recommended that the blood pressure is checked regularly.
Venous pressure
To protect the patient against a hazardous blood loss to the environment
AK 96 dialysis machine incorporates a venous pressure monitoring
system. This system will react on a change in the venous pressure,
HCEN12239 Revision 12.2010
Program version 3.xx
AK 96 ® Operator's Manual - Before you get started 1:15