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BIOTRONIK Enticos 4 DR User Manual

BIOTRONIK Enticos 4 DR
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Enticos 4/8
Pacemaker | Bradyarrhythmia Therapy |
Cardiac Resynchronization Therapy
Technical Manual
417804
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 417804Technical ManualEnticos 4/8
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 Enticos 4 DR Specifications

General IconGeneral
Device TypeImplantable Cardioverter Defibrillator (ICD)
ManufacturerBIOTRONIK
Bradycardia PacingYes
Tachycardia DetectionYes
MRI ConditionalYes
Pacing ModesDDD, VVI, AAI
Tachycardia TherapyAnti-tachycardia pacing, cardioversion, defibrillation
Remote MonitoringYes (BIOTRONIK Home Monitoring)
ProgrammingBIOTRONIK Programmer
Defibrillation EnergyUp to 40 Joules

Summary

Product Description

Intended Medical Use

Defines the primary purpose and objectives of the Enticos pacemaker therapy for bradycardia.

Diagnostic and Therapy Functions

Resynchronisation Therapy

Describes functions for synchronizing ventricular contraction in triple-chamber devices.

Antibradycardia Pacing

Explains automatic pacing adjustments for bradycardia treatment.

General Safety Instructions

Operating Conditions

Specifies environmental and handling conditions for device operation and safety.

Possible Complications

Possible Technical Failures

Lists potential causes of technical failures in the device system.

Electromagnetic Interference (EMI)

Discusses device sensitivity to external electromagnetic interference.

Device Behavior in Case of EMI

Explains how the device responds to electromagnetic interference.

Possible Risks

Procedures to Avoid

Lists medical procedures that must be avoided to prevent patient harm or device damage.

Potentially Risky Therapeutic and Diagnostic Procedures

Addresses risks associated with electrical current during procedures and necessary precautions.

External Defibrillation

Explains potential device damage and effects of external defibrillation.

Radiation Therapy

Advises on risks and necessary measures for radiation therapy with implanted devices.

Magnetic Resonance Imaging

Warns against MRI due to potential device damage and patient harm.

Implantation

Implantation Procedure

Outlines the steps and preparation required for pacemaker implantation.

Connecting the Lead Connector to the Device

Details the process of connecting pacemaker leads to the device header.

Avoid Damage to the Header

Provides instructions to prevent damage to the device header during implantation.

Applying the Programming Head

Guides on correctly positioning the programming head for telemetry.

Establishing Wandless Telemetry

Explains how to establish wireless communication with the programmer.

Auto-initialization

Describes the automatic initialization process after lead connection.

Behavior During Auto-initialization

Explains device behavior during and after auto-initialization.

Precautionary Measures while Programming

Checking the Device System

Specifies follow-up actions after auto-initialization to ensure proper function.

Preventing Device-Induced Complications

Lists functions to prevent complications like PMT protection.

Performing Standard Tests and Monitoring the Patient

Highlights critical conditions during tests and the need for patient care.

Preventing Conduction of Atrial Tachycardia

Details methods to prevent atrial tachycardia conduction to the ventricle.

Avoiding Critical Parameter Settings

Advises against setting risky parameter combinations.

Phrenic Nerve Stimulation

Addresses phrenic nerve stimulation during LV pacing and its persistence.

Setting Sensing

Discusses manual parameter settings and the use of automatic sensitivity.

Avoiding Risks in Case of Exclusive Left Ventricular Pacing

Warns about risks associated with exclusive LV pacing.

Recognizing Lead Failure

Explains how lead failure is detected through impedance monitoring.

Magnet Response

Follow-up

Replacement Indications

Explantation and Device Replacement

Parameters

Pacing and Sensing

Rate Adaptation

CLS Modes: Closed Loop Stimulation

Details parameters for Closed Loop Stimulation (CLS) based on physiological impedance.

Preset Programs

Battery Data

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