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Patient Population | Pediatric and adult patients |
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Drive Unit | Pneumatic |
Material (Blood Contacting) | Polyurethane |
Device Type | Ventricular Assist Device (VAD) |
Intended Use | Mechanical circulatory support for patients with severe heart failure |
Pump Sizes | 10 mL, 15 mL, 25 mL, 30 mL, 50 mL, 60 mL, 80 mL |
Stroke Volume | Varies by pump size |
Cardiac Output | Variable, depending on pump size, stroke rate, and stroke volume (up to several liters per minute) |
Monitoring | Integrated pressure and flow monitoring |
Power Source | Electrical power for the drive unit and control unit; backup power options available. |
Cannulation Options | Atrial and ventricular cannulation options |
Regulatory Approvals | CE marked, FDA approved |
Flow Range | Up to several liters per minute, depending on pump size and settings |
Explains the meaning of warning symbols, cautions, notices, and advice used in the manual.
Outlines essential safety guidelines for using the EXCOR system, including training and component integrity.
Covers safety aspects related to system configuration, caregiver supervision, and environmental conditions.
Explains the internal structure and the primary function of the EXCOR Active driving unit.
Describes the control panel, indicator lights, buttons, and display functions of the driving unit.
Covers connecting various components, flow sensors, power supply units, and battery management.
Covers user login procedures, access rights, and the patient monitoring view.
Details how to set parameters for blood pumps, including filling/emptying and rate adjustments.
Guides on switching on the system and performing essential function checks before patient use.
Describes the three options for configuring the driving unit: Manual, From File, and Replacement.
Details the critical steps for de-airing, starting, and setting blood pumps for LVAD, RVAD, and BVAD modes.
Provides guidance on adjusting settings to ensure proper filling and emptying of blood pumps for optimal performance.
Emphasizes safety during error handling and identifies contact persons for support.
Explains alarm priorities, visual/audible alarms, and how to identify them on the driving unit and panel PC.
Lists specific alarm codes, messages, instructions, and references for troubleshooting.
Details panel PC error messages and specific alarms like H1/H2 and battery issues.
Outlines prescribed maintenance intervals by the manufacturer and operator inspections.
Provides general rules and specific notes on cleaning and disinfecting system components.