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Berlin Heart EXCOR Series User Manual

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EXCOR
®
Adult
EXCOR
®
Pediatric
EXCOR
®
VAD
Ventricular Assist Device
EXCOR
®
Active Driving System
Instructions for Clinical Use
Edition 1.0

Table of Contents

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Berlin Heart EXCOR Series Specifications

General IconGeneral
Patient PopulationPediatric and adult patients
Drive UnitPneumatic
Material (Blood Contacting)Polyurethane
Device TypeVentricular Assist Device (VAD)
Intended UseMechanical circulatory support for patients with severe heart failure
Pump Sizes10 mL, 15 mL, 25 mL, 30 mL, 50 mL, 60 mL, 80 mL
Stroke VolumeVaries by pump size
Cardiac OutputVariable, depending on pump size, stroke rate, and stroke volume (up to several liters per minute)
MonitoringIntegrated pressure and flow monitoring
Power SourceElectrical power for the drive unit and control unit; backup power options available.
Cannulation OptionsAtrial and ventricular cannulation options
Regulatory ApprovalsCE marked, FDA approved
Flow RangeUp to several liters per minute, depending on pump size and settings

Summary

Introduction to EXCOR Active System

Safety Information and Signal Words

Explains the meaning of warning symbols, cautions, notices, and advice used in the manual.

General Information on EXCOR Active

Safety Information and Precautions

General Safety Precautions

Outlines essential safety guidelines for using the EXCOR system, including training and component integrity.

Configuration and Ambient Conditions Safety

Covers safety aspects related to system configuration, caregiver supervision, and environmental conditions.

Driving Unit Operation and Setup

Structure and Primary Function of Driving Unit

Explains the internal structure and the primary function of the EXCOR Active driving unit.

Control Panel, Indicator Lights, and Buttons

Describes the control panel, indicator lights, buttons, and display functions of the driving unit.

Connections and Power Supply Management

Covers connecting various components, flow sensors, power supply units, and battery management.

Panel PC and Docking Station Usage

EXCOR Active User Interface

User Login, Access Rights, and Monitoring

Covers user login procedures, access rights, and the patient monitoring view.

Blood Pump and Parameter Settings

Details how to set parameters for blood pumps, including filling/emptying and rate adjustments.

Configuring and Operating the Driving Unit

System Power-Up and Function Checks

Guides on switching on the system and performing essential function checks before patient use.

System Configuration Options

Describes the three options for configuring the driving unit: Manual, From File, and Replacement.

De-Airing, Starting, and Setting Blood Pumps

Details the critical steps for de-airing, starting, and setting blood pumps for LVAD, RVAD, and BVAD modes.

Optimizing Filling and Emptying of Blood Pumps

Provides guidance on adjusting settings to ensure proper filling and emptying of blood pumps for optimal performance.

Replacing the Driving System

Manual Pump Operation

Identifying Errors and Troubleshooting

General Safety and Contact Information

Emphasizes safety during error handling and identifies contact persons for support.

Driving Unit and Panel PC Alarms Explained

Explains alarm priorities, visual/audible alarms, and how to identify them on the driving unit and panel PC.

Alarm Codes and Troubleshooting Tables

Lists specific alarm codes, messages, instructions, and references for troubleshooting.

Panel PC Messages and Specific Alarms

Details panel PC error messages and specific alarms like H1/H2 and battery issues.

Maintenance, Cleaning, and Disinfection

Maintenance Intervals and Operator Inspections

Outlines prescribed maintenance intervals by the manufacturer and operator inspections.

Cleaning and Disinfection Guidelines

Provides general rules and specific notes on cleaning and disinfecting system components.

Technical Specifications

Overview of Parameters

Electromagnetic Compatibility (EMC)

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