| 10 | BC 20 plus / BC 60 plus / BC 140 plus |
–
Use anticoagulants; e.g., heparin or argatroban.
–
Check the effect of anticoagulants at regular intervals by measuring the ACT (activated
clotting time). Ensure that the ACT value does not fall below the value which is appropri-
en
ate for the application. The ACT should not fall below 480 s.
–
Check the coagulation status of the patient's blood regularly. The protocol for coagula-
tion management is the responsibility of the user in charge.
n
Particles may enter the tube circuit due to ambient conditions and shear forces during as-
sembly. This can lead to infections and inadequate patient support.
–
Use an arterial filter.
n
The detachment of unsecured tube connections can lead to blood loss and air embolisms in
the patient.
–
Check that tube connections are correctly and securely fastened.
–
Secure all tube connections in the tube system with hose ties.
n
Mechanical forces may act on the components during the application. This can lead to
blood loss, embolisms and inadequate patient support.
–
Secure all connections.
–
Avoid excessive tension and check the integrity and leak-tightness of the components
immediately.
–
Avoid intra-hospital transportation.
–
Ensure that the tubes are not kinked.
n
In the event of leakages, stop and clamp the hemoconcentrator circuit in order to prevent
infections, blood loss and embolisms in the patient.
–
Always keep 4 metal tube clamps at the ready.
–
Make sure that the metal tube clamps have no sharp edges.
5.3
Safety Instructions for the Hemoconcentrator
n
Exceeding the permissible maximum values damages the device. This can lead to embolisms
and inadequate patient support.
–
Observe the permissible maximum values for blood flow as well as pressure on the
blood side.
n
The membrane can be damaged by transmembrane pressure peaks and brief but significant
increases in filtrate flows caused by pressure peaks. This can damage the fiber and cause
the device to leak. This can lead to blood loss and infection in the patient, and cause the ap-
plication to be delayed.
–
Avoid repeatedly clamping and opening the filtrate line during priming when the blood
pump is running and the blood outlet is clamped.
–
Do not generate an abruptly created or increased vacuum on the filtrate side (if the fil-
trate line is clamped when the vacuum pump is running and is opened to start ultrafiltra-
tion).
–
Start a vacuum created on the filtrate side with low negative pressures and increase the
vacuum slowly to the required value. This protects the hollow fibers.
–
Change the pressure, the vacuum and the flow slowly.
–
Avoid abrupt changes.
n
As the hemoconcentrators are highly permeable, a high concentration of red cell mass is
quickly reached. If the concentration is too high, this can cause hypovolemia in the patient
and increase the risk of thrombosis and the risk of filter blockage.
–
Ensure a target hematocrit of less than 50%, depending on which therapy is required.
n
Failure to de-air the tube system and device completely can cause embolisms in the patient.
Priming with blood can promote clotting and leaks. This can lead to blood loss in the patient
and cause delays in the procedure.
–
Prime and de-air the hemoconcentrator before use.
–
Do not use blood components for priming.
–
For priming, use heparin or an alternative anticoagulant according to the clinical proto-
col.
Instructions for Use | 2.7 | G-153 | 07