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General| Brand | Abiomed |
|---|---|
| Model | Impella RP |
| Category | Medical Equipment |
| Language | English |
Specifies approved uses for the Impella RP System in pediatric and adult patients.
Lists conditions where the Impella RP device should not be used.
Lists potential complications associated with the Impella RP system.
Alerts users to situations that could cause death or serious injury.
Alerts users to situations that may cause equipment malfunction or damage.
Covers training, fluoroscopy, sterility, disposal, MRI, and defibrillation precautions.
Addresses retrograde flow, saline use, system damage, and flammable anesthetics.
Details precautions regarding electromagnetic compatibility and transport.
Advises on avoiding overinsertion and torquing the catheter.
Emphasizes careful handling to prevent catheter damage and specifies correct accessories.
Covers purge cassette replacement time, heat exposure, and battery charging.
Advises having backup equipment available in case of device failure.
Warns against using the left femoral vein due to potential manipulation issues.
Displays real-time data including placement and motor current waveforms.
Explains the pressure measurement waveform and its scaling.
Describes the motor current waveform and its scaling.
Displays purge system data like flow rate and pressure.
Explains how purge flow rate and pressure are displayed.
Displays infusion volume and amounts of heparin and dextrose.
Shows an example of the infusion history screen.
Details operating the controller on battery power.
Highlights precautions for handling the sensitive Impella RP Catheter.
Explains how to start the setup procedure via the MENU or plugging in the catheter.
Shows the screen displayed after selecting "Case Start".
Provides step-by-step instructions for inserting the purge cassette.
Highlights sterile technique steps and Y connector disposal.
Details how to connect the catheter plug to the connector cable.
Explains the importance of snapping the plastic clip for tube kinking prevention.
Guides on connecting the connector cable to the Automated Impella Controller.
Describes the controller prompting and progress of purge lumen priming.
Guides on connecting the purge tubing to the catheter.
Details entering purge fluid volume, dextrose, and heparin concentrations.
Explains how to select default or custom purge fluid settings.
Instructs on connecting purge tubing to the white connector cable.
Illustrates the correct setup of the Impella RP System.
Notes that surgical procedures are the responsibility of the medical professional.
Lists safety precautions during catheter insertion.
Provides detailed steps for inserting the catheter into the femoral vein.
Details loading the catheter onto the guidewire and stabilizing it.
Guides on advancing the catheter through the valve and positioning.
Emphasizes fluoroscopy for accurate placement confirmation.
Warns about retrograde flow at specific performance levels.
Describes the placement signal and operation initiation.
Guides on increasing performance level to P9 for stable placement.
Details flushing the sidearm and sheath.
Instructs on removing the introducer completely.
Guides on securing the sheath and anticontamination sleeve.
Explains the ten performance levels (P0-P9) and their flow rates.
Addresses suction issues and how to resolve them by adjusting performance levels.
Emphasizes completing purge cassette replacement within 2 minutes.
Lists the four main procedures for maintaining the purge system.
Details steps to change both the purge cassette and fluid.
Provides instructions for changing only the purge fluid.
Suggests flushing fluid when changing dextrose concentration.
Explains when and how to replace the purge cassette.
Guides on removing air from the purge system.
Details actions for the "Purge Pressure Low" alarm.
Provides steps for leaks, fluid concentration, and cassette replacement.
Explains the "Purge System Open" alarm and its causes.
Covers alarms for high purge pressure and blocked systems.
