Delcath Systems CHEMOSTAT Mode D'emploi page 11

(i) R emove the " Prime/Flush" line from its sterile pouch and attach it to the quick
connect coupling located proximal to Y-connector " F", as shown below and place
the open end into basin for collecting the flushed effluent during filter hydration.
F
E
7 8
FILTER FILTER
OUTFLOW OUTFLOW
This Side Up
FILTER FILTER
INFLOW INFLOW
(j) A ttach the supplied stopcocks to the " B" (pre-pump), " D" (pre-filter) and " F"
(outlet) Y-connector ports. Verify " Bypass Line" clamp 4 is open.
F
11
E
7 8
FILTER FILTER
OUTFLOW OUTFLOW
This Side Up
Hemofiltration
Cartridges
FILTER FILTER
INFLOW INFLOW
5
6
D
4
C
Bypass
Line
9
Prime / Flush Line
1 2
A
B
10
Flow Probe
(k) System CO Prime (Note: if CO
2 2
• C lose outlet clamp (11), attach the CO
and open the stopcock (see below).
F
Pressure Relief Value
- protect circuit from
11
over-pressurization
CO Connection Line
2
Luer end attached to "F"
stopcock, and open end
to CO source regulator
E 2
8
7
FILTER FILTER
OUTFLOW OUTFLOW
This Side Up
FILTER FILTER
INFLOW INFLOW
5
6
D
4
C
Flow Probe
Bypass
Line
• C onnect the open end of the CO
CO source regulator to 3psi (approximately 3.0 liters per minute (LPM)).
2
• S tart the CO gas flow and allow the CO
2
circuit. Adjust CO regulator to maintain 3psi (as necessary). Verify CO
2
through the circuit.
• C lose bypass clamp (4) after approximately 1 minute to ensure flow through
the hemofiltration cartridges. Allow CO
closing clamp 4) for at least 5 minutes.
• C lose saline clamps (1, 2), double balloon catheter line clamp (3), filter
inlet clamps (5, 6), and then filter outlet clamps (7, 8) to lock CO
circuit. Stop the CO flow, and close the stopcock " F" and disconnect the CO
2
connection line and discard.
(l) Hang two bags of the heparinized sterile saline and connect to circuit by using
the saline spikes, as shown, to allow for gravity priming of circuit components.
CAUTION: Use strict aseptic technique while spiking the heparinized saline
bags.
1
A
11
gas not available, skip to step (l)):
connection line to the stopcock " F",
2
CO Source
2
(not provided) - with
regulator set at 3psi and
flow control at 3 LPM
In-line Filter -
provides
sterile/filtered CO
2
1
2
A
3
B
10
connection line to the CO source, and set the
2 2
to flow through the hemofiltration
2
to flow through the cartridges (after
2
within the
2
Heparinized Saline
Saline Spikes for connecting to
Saline Bags
2
B
flow
2
2