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BIOTRONIK Edora 8 DR-T User Manual

BIOTRONIK Edora 8 DR-T
51 pages
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Edora 8
Pacemaker |
Bradyarrhythmia Therapy |
Cardiac Resynchronization
Therapy
Technical Manual
459754
Revision: Q (2022-05-16)
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BIOTRONIK Edora 8 DR-T Specifications

General IconGeneral
Device TypeImplantable Cardioverter Defibrillator (ICD)
ManufacturerBIOTRONIK
ModelEdora 8 DR-T
ChamberDual Chamber
ProgrammabilityYes
Rate ResponsiveYes
MRI ConditionalYes
Battery TypeLithium

Summary

Product Description

Indications for Use

Details the medical conditions and patient criteria for which the pacemakers are indicated.

General Safety Instructions

Safe Handling and Warnings

Provides instructions for safe handling, outlines warnings, and categorizes hazardous situations.

Operating Conditions and Storage

Details operating conditions, shipping/storage care, sterile delivery, and single-use requirements.

Special Risks and Procedures

Highlights risks, procedures to avoid, risky medical procedures, and external defibrillation.

Radiation Therapy and MRI Safety

Addresses risks of radiation therapy and precautions for MRI scans with ProMRI devices.

Implantation

Implantation Procedure Overview

Overview of implantation, required parts, EMI checks, and defibrillator readiness.

Header and Lead Connection Safety

Safety for header, preventing shorts, lead spacing, and connecting leads.

Programming Precautions and Settings

Programming precautions, system checks, patient monitoring, telemetry cancellation, parameter settings, and lead polarity.

Device Follow-up and Monitoring

Covers follow-up procedures, intervals, and integration with Home Monitoring.

In-Office Follow-up with Programmer

Step-by-step guide for conducting an in-office follow-up using the programmer.

Explantation, Replacement, and Disposal

Covers explantation, device replacement, cremation, and safe disposal procedures.

Parameter

Ventricular, Upper Rate, and Mode Switching

Covers ventricular pacing, upper rate limits, and mode switching parameters.

Pacing, Sensing, and Capture Control

Configures pacing, sensing, and capture control parameters.

Rate Adaptation Features

Details rate adaptation, CLS modes, and accelerometer R modes.

MRI Program Parameters

Covers MRI modes and preset parameters for ProMRI devices.

Technical Data

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