It controls the impella catheter performance, monitors for alarms, and displays realtime hemodynamic and catheter position information. Below you will find the impella heart pump instructions for use for the impella, 2. It contains clinical and technical considerations to guide healthcare professionals in their use of the impella controller with the impella 2. Impella ventricular support systems p140003s018 fda. This instructional video provides the steps to gain femoral access and insert the impella 2. Open, follow the instructions presented in section 5 of this manual. First ever percutaneous heart pump approval in japan. Read this entire manual before using the impella controller and impella 2. Abiomed manuals manualslib has more than 7 abiomed manuals. This manual provides instructions for use of the impella 2.
Warnings and cautions discusses the warnings and cautions pertaining. View and download mercruiser black scorpion user manual online. Impella device instructions for use product manuals abiomed. Aortic valve stenosiscalcification equivalent to an orifice area of 0. Important safety information for the impella heart pump impella. The users can include the hospitals clinicians, abiomed local support staff, and clinical support center csc team members. For additional information about flow rates see the instructions for use manual. Product manual for impella rp heart pump software v6. Fda summary of safety and effectiveness data page 4 the impella 2. Impella device instructions for use product manuals. Severe peripheral arterial disease precluding placement of the impella.
Designed for percutaneous insertion into the femoral artery and positioned across the. The impella heart pump is inserted through the femoral or axillary artery into the left ventricle or, in the case of the ld, surgically via the ascending aorta. The automated impella controller is the primary user control interface for the impella platform featuring a 10inch highresolution display. Page 2 of 00424000 imc, impella controller user manual abiomed. Once in position, and turned on, blood is drawn into the impella from the left ventricle and. Warnings and cautions discusses the warnings and cautions pertaining to. Medgadget editors cardiac surgery, cardiology, radiology.