Prime Isofuse® Catheter Line; Prime Bypass Line; Prime And Flush Dual Filter Cartridge (Chemofilter); Slow Prime And Hydrate Dual Filter Cartridge (Chemofilter) - Delcath Systems CHEMOSTAT Mode D'emploi

2. Prime Isofuse® Catheter Line
(a) Close pre-pump clamp (10), open Isofuse catheter line clamp (3), open saline
line, and stopcock " B" to allow heparinized saline to prime line up to clamp 3 and
stopcock. Once the stopcock and double balloon catheter line are primed, close
clamp 3 and stopcock. Do not allow excess saline to fill wrap.
3
B
Pump Head
10
Close off line by closing the
locking Clamp 10

3. Prime Bypass Line

(a) Prime the pump head, inflow filter and bypass lines by opening clamp 10 and
stopcock " D".
4. Prime and Flush Dual Filter Cartridge (Chemofilter) – Post CO
CO gas was not available, skip to step 5)
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CAUTION: Do NOT allow heparinized saline bags to run dry or air will enter
the system.
(a) O pen filter inlet clamps (5, 6) then filter outlet clamps (7, 8) and circuit outlet
clamp (11) and adjust the flow of saline into the filter to a rate of approx. 0.5
liters per minute. Note: Hemostats (forceps) are required to adjust flow rate if
using gravity.
CAUTION: Do not use excessive force when tapping the plastic housing.
(b) Allow saline to flow out through the filters and out the prime/flush line for
approximately six (6) minutes or until the filter appears gas free (solid black).
Once all gas appears to have been displaced, tap gently to encourage any trapped
gas bubbles to rise, turn cartridge within housing to visualize and access entire
filter. Only tap on the sides of the cartridge (Do not tap on the end caps or quick
connector couplings).
(c) When Filter Cartridges are gas free, flush with an additional six (6) liters of
heparinized saline (3 L/cartridge).
(d) C lamp all filter lines (5, 6, 7, 8) and outlet clamp 11.
5. Slow Prime and Hydrate Dual Filter Cartridge (Chemofilter) – (Note: skip this
entire step if system and filters were primed with CO
(a) Slowly prime both Cartridges by opening the Inlet clamps 5 and 6 and Outlet
clamps 7 and 8. Using a tube clamp (forceps) placed between the " C" and
"D" Y-connectors; restrict the flow to slowly fill the cartridges at a rate of
approximately 1cm per minute.
(b) Once filled, tap gently to encourage air bubbles to rise, turn cartridge within
housing to visualize and access entire filter. Only tap on the sides of the cartridge
(Do not tap on the end caps or quick connector couplings). Occasionally stop flow
and continue to tap to allow air bubbles to rise and purge from filter media.
CAUTION: Do not use excessive force when tapping the plastic housing.
Sterile Wrap
Prime (Note: if
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6. Prime Return Line and Bubble Trap

gas)
2
12
(c) O nce cartridges are primed and fully hydrated, close clamps 5 and 6 and 7 and 8.
E
7
8
FILTER FILTER
OUTFLOW OUTFLOW
This Side Up This Side Up
Delcath
Hemofiltration
Cartridges
(Chemofilter)
FILTER FILTER
INFLOW INFLOW
5 6
D
Flow Probe
4
C
Use Tube Clamp to restrict flow to
achieve a fill rate of approximately
Bypass
Line 1 cm/min.
(d) Flush the effluent through the Cartridges until six (6) liters of heparinized
saline have passed through. As the bags are emptied, the pump will need to be
stopped to add new bags to the system – Do NOT allow the Heparinized Saline
bags to run dry or air will enter the system.
(e) After six (6) liters of Heparinized Saline are flushed through the Filter Cartridges
(3L/cartridge), clamp all filter lines (clamps 5, 6, 7 and 8) and clamp 11 (located
by Y-connector " F").
CAUTION: Do NOT install the Return Line with built-in Bubble Trap until
flushing is complete.
(a) Disconnect and dispose of the prime/flush line, by pressing in the latch located
on the female quick connect coupling and pulling it a part.
(b) Open the sterile pouch with the venous return line and built-in bubble trap, and
only remove the bubble trap end (leave distal end of line with luer connector
inside sterile pouch & secure with forceps, as shown). This will allow for the
interventional radiologist to make a sterile wet connection to the patient at a
later time.
11
F
E
Use forceps to keep distal end of the
Venous Return Line inside sterile pouch
7 8
until time to connect to patient
FILTER FILTER
OUTFLOW OUTFLOW
This Side Up
FILTER FILTER
INFLOW INFLOW
CAUTION: Monitor bubble trap frequently during the procedure and
remove trapped air as needed.
Heparinized Saline
1 2
A
3
B
10
(Add syringe to top of Bubble Trap to
aspirate air, as necessary)
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