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BIOTRONIK Enitra 8 DR-T User Manual

BIOTRONIK Enitra 8 DR-T
42 pages
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Enitra 6/8 Pr oMRI
®
Pacemaker | Bradyarrhythmia Therapy |
Cardiac Resynchronization Therapy
Technical Manual
417801
Revision: B (2016-03-23)
© BIOTRONIK SE & Co. KG
All rights reserved.
Specification subject to modification, revision and improvement.
® All product names in use may be trademarks or registered trademarks held
by BIOTRONIK or the respective owner.
Index 417801Technical ManualEnitra 6/8
0123 2016
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
sales@biotronik.com
www.biotronik.com
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BIOTRONIK Enitra 8 DR-T Specifications

General IconGeneral
BrandBIOTRONIK
ModelEnitra 8 DR-T
CategoryMedical Equipment
LanguageEnglish

Summary

Product Description

Intended Medical Use

Specifies the intended use of the Enitra pacemaker family for bradycardia indications.

Indications

System Overview

BIOTRONIK Home Monitoring System

Describes the therapy management system for automatic data transmission and evaluation.

Diagnostic and Therapy Functions

Antibradycardia Pacing Features

Describes sensing, pacing thresholds, capture control, and timing functions for pacing.

Resynchronisation Therapy Capabilities

Details functions for resynchronizing ventricles and automatic capture control.

General Safety Instructions

Safety Precautions and Warnings

Provides general caution regarding cardiac electrotherapy and necessary precautionary measures.

Possible Complications

General Medical Complications

Covers common complications like fluid accumulation, infections, tissue reactions, and therapy efficacy.

Possible Risks

Risky Diagnostic and Therapeutic Procedures

Discusses risks from external electrical current, diathermic procedures, and external defibrillation.

Implantation Procedure

Preparation and Device Handling

Emphasizes readiness of defibrillator, proper unpacking, and checking parts for damage.

Connecting Leads and Auto-Initialization

Details connecting leads, using the programming head, and the auto-initialization process.

System Checking and Patient Monitoring

Precautions for checking device systems, performing tests, and continuously monitoring the patient.

Telemetry Handling Precautions

Guidelines on not interrupting telemetry and procedures for cancelling telemetry.

Parameter Setting Precautions

Advice on avoiding critical settings, manual polarity, sensing, and sensitivity adjustments.

Preventing Device-Related Complications

Lists functions to prevent device-induced complications, atrial tachycardia, and phrenic nerve stimulation.

Risks of Ventricular Pacing and Lead Failure

Discusses risks of LV pacing, lead dislodgement, and recognizing lead failure.

Follow-up Procedures and Intervals

Specifies follow-up intervals, use of Home Monitoring, and programmer-based follow-up.

Replacement Indications and ERI Display

Explains replacement indications, ERI activation, display, rate decrease, and deactivated functions.

Service Times and Magnet Response at ERI

Provides information on expected service times and magnet response after reaching ERI.

Explantation and Device Replacement Procedures

Details explantation, device replacement, cremation, and environmentally safe disposal of explants.

Parameters

Timing Parameters

Covers basic rate, night rate, rate hystereses, AV delay, and AV hysteresis.

Pacing and Sensing Parameters

Covers pulse amplitude, pulse width, sensitivity, and capture control parameters.

Technical Data

Battery Data and Service Life

Provides battery characteristics, service time calculations, and data from manufacturers.

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