User Manual
AXILLARY INSERTION OF THE IMPELLA
5.5
®
CATHETER
NOTE – Proper surgical procedures and techniques are the
responsibility of the medical professional. The described
procedure is furnished for information purposes only. Each
physician must evaluate the appropriateness of the procedure
based on his or her medical training and experience, the type of
procedure, and the type of systems used.
If the Impella Catheter is used in the OR as part of open heart surgery,
manipulation may be performed only at the access site. Direct manipulation
of the catheter assembly through the aorta or ventricle may result in serious
damage to the Impella Catheter and serious injury to the patient.
When using a pigtail diagnostic catheter with side holes, ensure that the
guidewire exits the end of the catheter and not the side hole. To do so,
magnify the area one to two times as the guidewire begins to exit the pigtail.
During placement of the Impella Catheter, take care to avoid damage to the
inlet area while holding the catheter and loading the placement guidewire.
The introducer and graft lock are supplied sterile and can be used only if
the packaging is not damaged and the expiration date has not elapsed.
Fluoroscopy is required for the insertion of the Impella guidewire and
Impella Catheter.
During insertion, avoid manual compression of the inlet or outlet areas of
the Impella Catheter or the sensor area of the cannula on the Impella 5.5
with SmartAssist Catheter.
The graft must be affixed to the introducer proximal to the retainers on the
introducer repositioning unit to prevent the introducer from sliding out of the
graft.
When inserting the Impella Catheter through the introducer and into
the graft, be sure to clamp the graft with a vascular clamp just above
the anastomosis to avoid blood loss through the pump cannula during
insertion through the valve.
The Impella Axillary Insertion kit is intended to be used for insertion only.
To provide continued hemostasis, the introducer must be peeled away and
the repositioning unit inserted into the graft.
Do
NOT
resterilize or reuse any components of the Impella Axillary
Insertion kit. All components are disposable and intended for single use
only. Reuse, reprocessing, or resterilization may compromise performance.
The introducer is designed to be inserted into a graft. It is not intended for
direct insertion into the artery.
Abiomed recommends the use of a 10 mm diameter Hemashield Platinum
graft with the introducer for proper fit and hemostasis between the graft
and the introducer. A smaller diameter graft may not fit over the introducer.
Abiomed recommends the use of a 20 cm length graft to allow enough
length to fully insert the Impella Catheter cannula into the graft prior
to releasing vascular clamps at the anastomosis to minimize blood loss
through the cannula.
Do
NOT
kink or clamp the white portion of the Impella Catheter with cm
markings with anything other than a soft jaw vascular clamp.
Do
NOT
kink or clamp the peel-away introducer.
Proper positioning of the Impella Catheter is extremely important and it is
worthwhile to take extra time when positioning the catheter.
Take care to insert the guidewire with diagnostic catheter into the middle
of the hemostatic valve of the introducer to avoid tearing the valve.
When inserting the Impella Catheter into the introducer, take care to
insert it straight into the center of the introducer valve.
Be sure that the stopcock on the peel-away introducer is always kept in the
closed position. Significant bleed back can result if the stopcock is open.
The following steps describe the recommended technique for axillary artery
insertion of the Impella 5.5
®
with SmartAssist
®
Catheter.
1.
Isolate and expose the axillary artery and obtain control via proximal and
distal vessel loops.
2.
Attach a 10 mm diameter x 20 cm long vascular graft to the axillary
artery using a standard end-to-side anastomosis.
NOTE:
Abiomed
recommends using a Hemashield Platinum graft and recommends using
at least a 60 degree bevel on the end of the graft to facilitate passage of
the rigid motor housing into the artery.
3.
Clamp the graft with a vascular clamp just above the anastomosis and
loosen the vessel loops to allow blood to flow into the graft to assess for
hemostasis at the anastomosis.
4.
Insert the introducer into the graft and secure it with one (1) provided
graft lock. To place the graft lock, open it and place it between the
retainers and the hub on the introducer to prevent the introducer from
sliding out of the graft.
NOTE:
If a graft other than the Hemashield
Platinum is used, two graft locks may be required to maintain hemostasis
between the graft and the introducer. Correct positioning of the second
graft lock is illustrated in below.
Introducer, Graft Lock, and Hemashield Platinum Graft (Graft Not Supplied)
Correct Positioning If Second Graft Lock Required
5.
Secure the graft lock by pressing both the outside tabs together. When
fully closed, the graft lock provides hemostasis. If hemostasis
is not achieved, make sure to press the two tabs together to fully close
the graft lock as shown below. The graft lock cannot be damaged by
over closing.
NOTE:
The graft may also be secured over the introducer
using heavy sutures or umbilical tape.
Closing the Graft Lock
6
Содержание Impella 5.5
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