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Berlin Heart EXCOR Pediatric - 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

Questions and Answers

Summary

2 Introduction to EXCOR Active System

Safety Information and Signal Words

Explains safety symbols (WARNING, CAUTION, NOTICE, ADVICE) and their corresponding meanings.

Pictograms and Safety Symbols

Illustrates and explains safety symbols used on components and in the manual for safe handling.

3 General Information EXCOR Active

Intended Use and Patient Population

Explains the EXCOR Active system's purpose for circulatory support and its intended patient age range.

4 Safety Information

General Safety Precautions

Covers general safety guidelines for EXCOR use, training, and component integrity.

Configuration and Caregiver Safety

Emphasizes readiness of replacement units and supervision of incapable patients/caregivers.

5 Driving Unit Operations

Driving Unit Structure and Primary Function

Explains the driving unit's pneumatic system, piston movement, and handling of unit failures.

Power Supply and Battery Management

Explains power sources (mains, battery, emergency) and battery insertion/charging procedures.

Emergency Battery and Charging

Details the function of the integrated emergency battery and its charging process.

Replacing and Configuring the Driving Unit

Outlines procedures for replacing driving units, including BVAD, LVAD, and RVAD patient types.

BVAD Emergency Operation

Explains system behavior during BVAD emergency operation when a pneumatic system fails.

6 Panel PC and Docking Station

Connecting Panel PC to Driving Unit via USB

Details connecting the panel PC to the driving unit using a USB cable for data transfer.

7 User Interface Navigation

Monitoring Patient Status

Describes the monitoring view for displaying patient status and key parameters like Flow and Rate.

Blood Pump Settings and Parameters

Introduces settings for blood pumps, including parameters like Rate, Flow alarm threshold, and Synchronization.

8 Configuring and Operating the Driving Unit

System Startup and Function Checks

Covers switching on the system and checking the functionality of driving units and panel PCs.

Configuring the System: Options and Methods

Explains configuration options (Manual, File, Replacement) and their respective prerequisites.

Manual Configuration: Patient and Settings

Guides through manual configuration: entering patient info and selecting driving unit settings.

Selecting Blood Pumps, Cannulae, and Parameters

Details selecting blood pumps, cannulae, and other parameters based on patient needs.

De-Airing, Starting, and Setting Blood Pumps

Explains de-airing, starting, and setting blood pumps for LVAD, RVAD, and BVAD operations.

Optimizing Blood Pump Filling and Emptying

Guides on optimizing pump filling/emptying by adjusting parameters like rate and piston stroke.

Setting Flow Alarm Threshold

Guides on setting the flow alarm threshold individually to detect insufficient support reliably.

Changing Operating Mode and Replacing Blood Pumps

Details changing operating mode and replacing blood pumps for BVAD, LVAD, and RVAD.

Replacing Driving Tubes and System Components

Explains procedures for replacing driving tubes and configuring replacement driving units.

9 Replacing the Driving System

Switching to EXCOR Active System

Provides steps for switching to the EXCOR Active system, including parameter transfer and initial operation.

Switching from EXCOR Active to Ikus

Details preparing the Ikus system and replacing the driving unit when switching back.

10 Weaning and Explantation Procedures

Performing Patient Explantation

Outlines the steps for performing patient explantation, including shifting support and powering down.

11 Performing Trainings

Training Target Groups and Safety

Identifies target groups (medical personnel, lay users) and emphasizes thorough training for safe operation.

15 Baby Buggy - Stroller Board

Positioning Driving Tubes on Baby Buggy

Warns to position driving tubes to avoid tensile force, loops, or kinks.

16 Manual Pump Usage

General Function and Safety Information

Explains the manual pump's role in emergencies and safety precautions for its use.

17 Identifying Errors and Troubleshooting

General Safety and Error Reporting

Covers safety for malfunctioning components and reporting serious incidents to manufacturer.

Audible Alarms and Reacting to Driving Unit Alarms

Explains audible alarm characteristics and steps for reacting to driving unit alarms.

Panel PC Alarms and Messages

Describes panel PC alarms mirroring driving unit errors and lists panel PC specific messages and solutions.

Specific Alarms: H1;H2, Battery, and Temperature

Addresses alarms related to insufficient support (H1/H2), battery issues, and flow sensor temperature.

18 Maintenance, Cleaning, and Disinfection

Safety Information and Maintenance Personnel

Emphasizes observing maintenance intervals and that inspections must be done by qualified personnel.

Cleaning and Disinfection Procedures

Covers general rules for cleaning and disinfection, including approved agents and intervals.

20 Technical Specifications

21 Overview - Parameters

22 Using the External Alarm (Nurse Call)

23 Electromagnetic Compatibility (EMC)

EMC Safety Information and Performance

Warns about unapproved accessories and maintaining distances from devices; lists tested performance characteristics.

Berlin Heart EXCOR Pediatric Specifications

General IconGeneral
BrandBerlin Heart
ModelEXCOR Pediatric
CategoryMedical Equipment
LanguageEnglish

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