Abiomed Impella 2.5, Инструкция по эксплуатации

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5.21 Impella
®
System for Use During Cardiogenic Shock
AXILLARY INSERTION OF THE IMPELLA
®
2.5, 5.0, OR
IMPELLA CP
®
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.
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
®
5.0
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 ® 5.0 Catheter.
The graft must be affixed to the introducer proximal to the retainers on the introducer
sheath 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 sheath 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 Impella
®
Axillary Insertion kit is not designed for use with the Impella
®
LD
Catheter.
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 will 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 Impella ® Catheter 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.
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