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10. Continue priming until the time display reaches zero seconds.
11. Confirm system set-up is successfully completed by removing foot from foot pedal.
Status panel displays READY and green icon is illuminated.
12. Activate hydrophilic coating by lightly wiping the catheter shaft with normal saline.
Ultra power pulse™ spray prep
The Power Pulse Spray feature can be used once the AngioJet™ Thrombectomy
System is set up and primed for use and the Catheter is positioned in the vasculature at
the target treatment site.
1. Prepare physician-specified solution according to the medication package insert in
a separate saline bag.
2. Prime the Thrombectomy Set with the physician-specified fluid, per
standard procedure.
enter power pulse Mode
1. Press the CATHETER button on the console.
2. Press CATHETER button a second time to advance to the screen for entering the
Power Pulse Mode.
3. Press an arrow button to select YES on the decision (YES/NO) screen to confirm
access to Power Pulse Mode.
4. Again press the CATHETER button.
note: The Power Pulse volume and time are displayed on the main screen and
"PP" is shown in the console display. The title on the screen should read INFUSION
IN PROGRESS.
power pulse spray Infusion procedure
note: The exact infusion procedure is to be determined by the physician.
1. Advance the catheter to treatment site.
2. Press the foot switch to infuse desired volume of physician-specified fluid.
note: Each pump stroke delivers approximately 0.6 cm
3. Catheter should be moved through treatment site at physician's discretion.
4. It is recommended to wait 15-20 minutes after thrombolytic infusion before
starting thrombectomy.
exit power pulse Mode
1. Select the Alarm Reset button to exit Power Pulse immediately and return to
Thrombectomy mode.
2. Alternatively, the Power Pulse mode may also be exited by the following procedure.
2.1. Access the decision (YES/NO) screen by pressing the CATHETER button.
2.2. Select NO and press CATHETER button again to advance to the READY screen.
note: Selecting NO alone does not exit Power Pulse mode; the CATHETER
button must be pressed to exit.
note: The Power Pulse volume will appear in the "ready state" and continue to
add to the total if the Power Pulse mode is re-entered. To reset this total, reload
the catheter.
patient preparation
warning: Cardiac arrhythmias during catheter operation have been reported in a small
number of patients. Cardiac rhythm should be monitored during catheter use and
appropriate management, such as temporary pacing, be employed, if needed.
Thrombectomy set Delivery and operation
note: AngioJet Ultra System thrombectomy treatments can be performed in
conjunction with definitive treatments of the residual stenosis such as PTA or
stent placement.
1. Catheter access to the target lesion can be achieved by either an ipsilateral or
a contralateral approach. The Catheter is intended to be introduced through
percutaneous access. A vascular sheath should be used to minimize trauma at
the access site. Ancillary guide catheters used during the procedure should have
an inner diameter that allows sufficient room for passage of the Catheter (See
Table 1). Guidewires or other standard devices and methods should be used to aid
in placement of the sheath and/or guide catheter.
note: A hemostasis valve should be attached to the guide catheter to prevent blood
loss and should have sufficient size to pass and seal around the catheter without
restricting the ability to advance and retract the catheter.
warning: Obstructing lesions that are difficult to cross with the catheter to access
thrombus may be balloon dilated with low pressure (≤ 2 atm). Failure to pre-dilate
difficult-to-cross lesions prior to catheter operation may result in vessel injury.
2. After guidewire is advanced to the treatment site, the the catheter will be back-
loaded and advanced over the guidewire.
(cc) of fluid.
3
figure 2. Tru-seal™ Hub operation
3. Before loading, open the hemostasis valve by pressing on the introducer on the
catheter hub (Figure 2).
4. Load the catheter over the guidewire, and advance the catheter over the wire until
the wire exits through the Tru-Seal hub.
5. Close the hemostasis valve by grasping the introducer and pulling back, you will
hear an audible click (Figure 2). No adjustment to the Tru-Seal hemostasis valve is
necessary, if leaking occurs; confirm the introducer piece is fully extended to the
closed position (Figure 2).
Caution: If resistance is felt during the advancement of the Thrombectomy Set to
lesion site, do not force or torque the catheter excessively as this may result in
deformation of tip components and thereby degrade catheter performance.
Caution: Do not exchange the guidewire. Do not retract the guidewire into the
catheter during operation. The guidewire should extend at least 3 cm past the
catheter tip at all times. If retraction of the guidewire into the Thrombectomy
Set occurs, it may be necessary to remove both the Thrombectomy Set and the
guidewire from the patient in order to re-load the catheter over the guidewire.
6. Activate the System by pressing the Console foot pedal. Thrombectomy may
be achieved by either distal-to-proximal or proximal-to-distal passes of the
catheter through the thrombus. Passes should be made at a rate of approximately
1-2 mm/sec.
note: The distal-to-proximal method should be used if the catheter can be
positioned safely and when the thrombus lesion is highly mobile with a proximal
attachment point.
warning: Monitor thrombotic debris/fluid flow exiting the Thrombectomy Set via the
waste tubing during use. If blood is not visible in the waste tubing during AngioJet
Ultra System activation, the catheter may be occlusive within the vessel; verify
catheter position, vessel diameter and thrombus status.
7. For optimal results, several passes with the catheter may be required.
warning: Operation of the AngioJet System causes transient hemolysis which may
manifest as hemoglobinuria. Table 1 lists maximum recommended run times in a
flowing blood field and total operating time for each Thrombectomy Set. Evaluate
5
OPEN
Open valve for
loading and
unloading
CLOSED
Close valve for
operation over
guide wire
Black (K) ∆E ≤5.0
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