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BIOTRONIK Enitra 6 SR User Manual

BIOTRONIK Enitra 6 SR
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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 6 SR Specifications

General IconGeneral
BrandBIOTRONIK
ModelEnitra 6 SR
CategoryMedical Equipment
LanguageEnglish

Summary

Product Description

Intended Medical Use

Describes the intended medical applications for the Enitra pacemaker family.

Indications

MR Conditional

Information about using pacemakers in MRI environments.

Contraindications

Guidelines

General contraindications for pacemaker implantation and use.

Pacing Modes and Parameters

Discusses contraindicated pacing modes and parameter combinations.

System Overview

Device Family

Describes the Enitra pacemaker device family variants.

Lead Connections

Explains the standardized lead connection types (IS-1, IS4).

Leads

Describes BIOTRONIK leads, their properties, and connection adapters.

Telemetry

Explains telemetric communication between device and programmer.

Programmer

Details the programmer's functions for implantation and follow-up.

Modes

Lists available pacing modes for different device types.

NBG Codes

Defines NBG codes for antibradycardia modes (AAIR, VVIR, DDDR, DDDRV).

BIOTRONIK Home Monitoring®

Describes the BIOTRONIK Home Monitoring therapy management system.

Diagnostic and Therapy Functions

Diagnostics Functions

Details diagnostic functions like sensing, pacing thresholds, and IEGM display.

Antibradycardia Pacing

Explains antibradycardia pacing features like capture control and timing.

Resynchronisation Therapy

Describes resynchronization therapy features for triple-chamber devices.

ProMRI Devices Recognize Magnetic Resonance Imaging Devices

Details how ProMRI devices handle MRI environments.

Home Monitoring Functions

Describes data transmission and medical information sent by Home Monitoring.

General Safety Instructions

CAUTION Safety Information

General safety precautions for cardiac electrotherapy.

Operating Conditions

Information on technical manuals, shipping, storage, temperature, and sterile delivery.

Possible Complications

General Information on Medical Complications

Discusses general complications for patients and device systems.

Possible Technical Failures

Lists possible causes of technical failures in the device system.

Electromagnetic Interference (EMI)

Discusses device sensitivity to EMI and BIOTRONIK's design.

Device Behavior in Case of EMI

Explains device behavior during electromagnetic interference.

Possible Risks

Procedures to Avoid

Lists procedures that may harm the patient or damage the device.

Potentially Risky Therapeutic and Diagnostic Procedures

Discusses risks associated with diagnostic/therapeutic procedures and patient insulation.

External Defibrillation

Explains potential damage from external defibrillation and electrode placement.

Radiation Therapy

Warns about radiation therapy risks and required measures.

Magnetic Resonance Imaging

Details risks and precautions for MRI scans with pacemaker devices.

Implantation

Implantation Procedure

Lists required parts and steps for implanting the device.

Having Parts Ready

Specifies the necessary components for implantation.

Keeping an External Defibrillator Ready

Emphasizes keeping an external defibrillator available for emergencies.

Unpacking the Device

Provides instructions and warnings for unpacking the device.

Overview: Implanting

Step-by-step overview of the implantation process.

Avoid Damage to the Header

Instructions to prevent damage to the device header during implantation.

Preventing Short Circuits in the Header

Warning and measure to prevent short circuits in open lead connector ports.

Keeping Distance Between Leads

Warning about lead spacing to prevent inadequate therapy.

Connecting the Lead Connector to the Device

Detailed steps for connecting lead connectors to the device header.

Establishing Wandless Telemetry

Steps to establish wandless telemetry contact with the programmer.

Auto-Initialization

Describes the automatic initialization process after lead connection.

Precautionary Measures while Programming

Avoiding Critical Parameter Settings

Guidance on avoiding risky parameter combinations.

Avoiding Risks in the Case of Exclusive Left Ventricular Pacing

Details risks associated with exclusive LV pacing and lead dislodgement.

If an ICD is Implanted at the Same Time, Do Not Permit Unipolar Pacing

Warning against unipolar pacing when an ICD is also implanted.

Magnet Response

Follow-up

Follow-up with BIOTRONIK Home Monitoring®

How Home Monitoring supports functional in-office follow-up.

Parameters

Rate Adaptation

MRI Program

MRI Modes

Modes available for devices marked ProMRI.

MRI Parameters

Preset parameters for the MRI program.

Battery Data

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