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BIOTRONIK Enitra 6 Series User Manual

BIOTRONIK Enitra 6 Series
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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 Series Specifications

General IconGeneral
BrandBIOTRONIK
ModelEnitra 6 Series
CategoryMedical Equipment
LanguageEnglish

Summary

System Overview

Diagnostic and Therapy Functions

Diagnostics Functions

Details data recording, impedance measurements, and IEGM display.

Antibradycardia Pacing

Explains sensing, pacing thresholds, timing, and rate adaptation features.

Resynchronisation Therapy

Describes functions for synchronizing ventricular contraction using VV delays and Capture Control.

General Safety Instructions

Safety Information

Safety information regarding cardiac electrotherapy operating conditions and risks.

Operating Conditions

Lists technical manuals, shipping, storage, temperature, and sterile delivery care.

Possible Complications

General Medical Complications

Discusses general complications like fluid accumulation, infections, and tissue reactions.

Possible Technical Failures

Lists potential causes of technical failure, including lead issues and component failures.

Electromagnetic Interference (EMI)

Addresses device sensitivity to interference and BIOTRONIK's design for minimal susceptibility.

Possible Risks

Procedures to Avoid

Lists procedures that may harm the patient or damage the device, like ultrasound and nerve stimulation.

Risky Therapeutic and Diagnostic Procedures

Discusses risks from external electrical currents and diathermic procedures like electrocautery.

External Defibrillation Risks

Explains device protection against defibrillation energy and potential lead damage.

Radiation Therapy Risks

Advises avoiding radiation therapy due to device damage risk and outlines safety measures if used.

Magnetic Resonance Imaging Risks

Details risks of MRI due to magnetic fields and warming, and ProMRI devices.

Implantation

Implantation Procedure Overview

Lists required parts and provides a general step-by-step overview of device implantation.

Preparation and Unpacking

Covers having parts ready, keeping a defibrillator, and safely unpacking the device.

Implantation Site and Steps

Describes general implantation locations and provides a step-by-step implantation guide.

Header and Lead Handling Precautions

Advises on preventing header damage, short circuits, and ensuring proper lead spacing.

Connecting Leads and Telemetry

Details connecting leads, using the programming head, and establishing wandless telemetry.

Auto-Initialization Process

Explains the automatic device initialization process after lead connection.

Precautionary Measures while Programming

System Checks and Patient Monitoring

Advises system checks, pacing threshold tests, and continuous patient monitoring.

Telemetry Handling

Provides guidance on not interrupting telemetry and safe cancellation procedures.

Parameter Setting Precautions

Recommends avoiding risky parameter combinations and checking compatibility.

Lead Polarity and Sensitivity Settings

Advises on setting lead polarity for bipolar leads and using automatic sensitivity control.

Preventing Device-Induced Complications

Details functions to prevent complications like PMT protection.

Avoiding Risks with LV Pacing

Highlights risks associated with LV pacing, such as lead dislodgement and loss of therapy.

Magnet Response

Follow-up

Follow-up Intervals

Specifies the recommended schedule for in-office follow-up appointments.

Follow-up with Programmer

Outlines the procedure for in-house follow-up using the programmer.

Replacement Indications

Parameters: Timing

AV Delay and AV Hysteresis

Covers AV delay parameters and AV hysteresis modes, including positive/negative settings.

Parameters: Ventricular Pacing and Mode Switching

Ventricular Pacing Parameters

Details parameters for ventricular pacing, triggering, and protection.

Mode Switching Parameters

Explains parameters for mode switching, intervention rate, and switch-to-mode criteria.

Parameters: Refractory Periods, Blanking, and PMT Protection

Refractory Periods

Details refractory periods for atrium, ventricle, and PVARP.

Pacing and Sensing

Pulse Amplitude and Pulse Width

Details parameters for pulse amplitude and pulse width for different leads.

Lead Configuration and IEGM Recordings

Rate Adaptation

MRI Program

Preset Programs

Technical Data

Electrical Characteristics

Details electrical characteristics determined at 37°C, 500 Ω.

Battery Data

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