ABIOMED

Circulatory Support Systems

Impella 5.5 Technical Bulletin v3 Aug 2020

Technical Bulletin

2 Pages

Impella 5.5 with SmartAssist SN:  V8.1  100%  MUTE ALARM  160  Placement Signals Ao  67/65  (mmHg)  (65) LV  61/-4  -20  Motor Current  (mA)  579/590  PURGE MENU  (580)  0 Impella Flow  6.2 Max 5.2 Min  P-9 DISPLAY  10 sec.  1000  TECHNICAL BULLETIN  (mmHg)  FLOW CONTROL  5.5  L/min  10 sec.  5.6 0.8  Purge System  Cardiac Output:  Purge Flow: Purge Pressure:  Cardiac Power 4.0 ml/hr Watts Output: 301 mmHg 2019-01-01 10:25  L/min  MENU  August 2020  Reminder of Impella 5.5® with SmartAssist® Best Practices for Purge Management What’s New Abiomed would like to draw attention to the importance of carefully following the Instructions for Use (IFU) and best practices for the Impella 5.5 with SmartAssist pump, particularly with regard to proper device priming during implantation and management of the purge system in the ICU.  Recommendations Proper functioning of the purge system is essential for optimal operation of the Impella 5.5. Abiomed suggests the following best practices be scrupulously followed during the initial priming of the Impella 5.5 and during subsequent purge system changes. 1. Ideal priming of the Impella 5.5 should take place concurrently during preparations for implant, while the vascular exposure or graft anastomosis are being performed. Longer duration purge priming, when convenient, ensures optimal delivery of the purge solution to the motor assembly prior to implantation. 2. During initial priming, hold the motor and the cannula in a vertical position and ensure purge fluid droplets are observed at the outlet window of the Impella 5.5 prior to exposing the pump to the blood environment. 3. Heparin in the purge system at the outset is a very important element of the purge system. Physicians should use their clinical judgement to assess the risks versus benefits of operating the Impella 5.5 device with lower concentrations of heparin to no heparin in the purge system. Note that in comparison to the other Impella devices, Impella 5.5 is designed with a lower purge flow rate which will result in an overall reduction in device delivered heparin to your patient. 4. Upon initial placement, ensure that the guidewire is removed prior to starting the Impella 5 .5 device. Ideally, the Impella 5.5 device is started by slowly increasing the pump speed through selection of pump performance levels (P-levels) until the desired maximum performance level is achieved for patient support. It is recommended to start at P2 and increase by two P-levels every minute. (i.e. P2 and wait for 1 minute, increase to P4 and wait 1 minute, increase to P6 and wait 1 minute, etc.). Physicians should use their clinical judgement to assess patient hemodynamic stability and the rate of increasing pump speed to the target performance level. • Prior to implant, it is encouraged to use the Impella Sidearm Retainer. If Impella Sidearm Retainer is not utilized then, it is recommended to install prior to transferring the patient to the ICU. • Abiomed recommends externally fixating the pump catheter using a 3-point fixation. • It is important to remember that cleaning agents, such as Isopropyl Alcohol (IPA) should not be used on the Impella sidearm and purge filter. 5. Finally, carefully review purge cassette and purge fluid bag replacement procedures prior to exchanging. The Abiomed Clinical Support Center (CSC) is available 24/7/365 to answer questions or walk bedside personnel thru the step-by-step purge cassette change wizard on the AIC console. Continue to next page. Clinical Support Center 24 hours per day, 7 days a week: 1-­800-­422-­8666 (US) + 49 (0) 180 522 466 33 (EU)  Abiomed, Inc. 22 Cherry Hill Drive, Danvers, MA 01923 USA p: 978-­646-1400 f: 978-­777-8411 marketing@abiomed.com  Three-Point Fixation  Sidearm Retainer
File Type: PDF
File Size: 3.78 MB
File Name: Impella 5.5 Technical Bulletin v3 Aug 2020.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions