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Defines the target users for the manual.
Specifies the approved clinical applications in the European Union.
Alerts to situations that can cause death or serious injury.
Highlights situations that may cause equipment malfunction or damage.
Lists situations where the Impella 5.5 system is not recommended.
Details potential risks and adverse events associated with the procedure.
Lists disposable parts of the Impella 5.5 system.
Identifies reusable parts of the Impella 5.5 system.
Provides a general description of the Impella 5.5 catheter.
Explains the function and use of the purge cassette.
Describes various accessories used with the Impella system.
Lists necessary items for device setup and operation.
Step-by-step guide for inserting the purge cassette.
Instructions for connecting the Impella catheter to the controller.
Inputting necessary purge fluid parameters into the controller.
Details how to properly connect and secure the purge tubing.
Preparation steps required before direct aortic insertion.
How to select and adjust the pump's P-level for optimal support.
Procedure for adjusting the LV placement signal for measurement accuracy.
Steps to input cardiac output measurements into the controller.
Reminders for timely entry of cardiac output data.
Procedures for maintaining the purge cassette system.
Instructions for replacing only the purge fluid bag.
Procedure to remove air from the purge system.
Information on alerts related to air detection in the purge system.
Guidance on the process of weaning the patient from Impella support.
Method for gradually reducing pump support during weaning.
Steps for removing the catheter when the introducer is still in place.
Steps for removing the catheter secured by the repositioning unit.
Procedures for closing the vascular graft site after removal.
Procedures for using Impella with MNS.
Explanation of alarm types, severity, and indicators.
Explains various symbols used in the manual.
Technical specifications for the Impella 5.5 catheter.
Physical dimensions of the Impella 5.5 catheter.
Guidelines for disposing of the Impella 5.5 catheter and accessories in the EU.
General| Manufacturer | Abiomed |
|---|---|
| Intended Use | Temporary ventricular support |
| Maximum Flow Rate | 5.5 L/min |
| Power Source | External console |
| Device Type | Percutaneous Heart Pump |
| Motor Size | Small enough for minimally invasive insertion |
| Indication | Cardiogenic shock |
| Duration of Support | Up to 14 days |
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