Table of Contents
Advertisement
Enitra 6/8
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.
0123 2016
Index 417801Technical ManualEnitra 6/8
®
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
Advertisement
Table of Contents
Related Manuals for BIOTRONIK Enitra 8 Series
Summarization of Contents
Product Description
Intended Medical Use
Defines the purpose and objectives of the Enitra pacemaker family for bradycardia.
Diagnosis and Therapy Forms
Explains how the pacemaker treats bradycardia and integrates cardiology/electrophysiology approaches.
Required Expertise
Outlines the necessary medical knowledge and training for users of the device system.
Indications
Guidelines of Cardiologicial Societies
Recommends following guidelines from cardiology associations for therapy indications.
Device Types and Pacing Modes
Lists device types and recommended pacing modes for specific symptoms and conditions.
Contraindications
Guidelines and Parameter Considerations
Discusses contraindications, inappropriate pacing modes, and parameter compatibility.
System Overview
Device Family and Variants
Describes the device family as single, dual, and triple-chamber with/without Home Monitoring.
Device Housing and Materials
Details the biocompatible titanium housing, hermetically sealed, and ellipsoid shape.
Lead Connections
Explains BIOTRONIK leads and standardized connections (IS-1, IS-1/IS4).
Telemetry and Programmer Functions
Explains telemetric communication and programmer functions for testing and data management.
Pacing Modes
Lists available pacing modes for different device types (SR, DR, HF QP).
NBG Codes and Home Monitoring
Explains NBG codes and the BIOTRONIK Home Monitoring therapy management system.
Diagnostic and Therapy Functions
General Overview and Auto-Initialization
Highlights features for quick diagnosis and safe bradycardia therapy, including auto-initialization.
Diagnostics Functions
Describes data recording, impedance measurements, and IEGM display with markers.
Antibradycardia Pacing Features
Explains sensing, pacing thresholds, capture control, timing, and rate adaptation features.
Resynchronisation Therapy
Details functions for ventricular resynchronization, Capture Control, and pacing polarities.
ProMRI and Home Monitoring Functions
Explains ProMRI device recognition of MRI and Home Monitoring data transmission.
General Safety Instructions
Cautionary Safety Information
Warns that cardiac electrotherapy requires special operating conditions and precautions.
Operating Conditions and Manuals
Lists technical manuals available for device system usage and operating conditions.
Shipping, Storage, and Temperature Guidelines
Advises on storing devices away from magnets and notes temperature effects on service time.
Sterile Delivery and Packaging
Describes sterile packaging and delivery, emphasizing intact seals for sterility.
Single Use Only Policy
Specifies device and screwdriver are for single use and must not be reused.
Possible Complications
General Medical Complications
Covers common complications like fluid accumulation, infections, and efficacy guarantees.
Skeletal Myopotentials and Stimulation
Explains sensing of skeletal myopotentials and potential nerve/muscle stimulation.
Technical Failures and EMI
Lists causes of technical failure and discusses device sensitivity to electromagnetic interference.
Device Behavior in EMI and Static Fields
Explains device response to EMI and static magnetic fields.
Possible Risks
Procedures to Avoid
Lists procedures that may harm the patient or damage the device.
Risky Therapeutic and Diagnostic Procedures
Warns about interference from external electrical current sources and diagnostic procedures.
External Defibrillation and Radiation Therapy Risks
Explains risks associated with external defibrillation and radiation therapy.
Magnetic Resonance Imaging Risks
Warns about MRI risks like device damage and patient warming due to magnetic fields.
Implantation
Implantation Procedure Overview
Lists required parts for implantation according to EC Directive 90/385/EEC.
Preparation and Device Handling
Covers having parts ready, keeping defibrillator ready, and safe device unpacking.
Header Protection and Lead Spacing
Advises on avoiding header damage, preventing short circuits, and lead spacing.
Connecting Leads and Telemetry
Details connecting leads, applying programming head, and establishing wandless telemetry.
Auto-Initialization Process
Explains when auto-initialization begins, its duration, and device behavior during the process.
Precautionary Measures while Programming
Cautionary Safety Information for Programming
Highlights the need for special precautions during device system programming.
Device System Checks and Patient Monitoring
Advises on performing follow-up and pacing threshold tests and monitoring the patient.
Telemetry Interruption and Cancellation
Warns against interrupting telemetry and provides steps for cancellation if needed.
Parameter Settings and Sensitivity
Advises avoiding risky parameter combinations and using automatic sensitivity control.
Preventing Device-Induced Complications
Lists functions to prevent complications like PMT protection and atrial tachycardia conduction.
Risks of LV Pacing and Lead Failure
Outlines risks of LV pacing, phrenic nerve stimulation, and recognizing lead failure.
Power Consumption and Service Time
Advises considering power consumption and its impact on battery service time.
Magnet Response
Programming Head Application
Explains how programming head application allows device interrogation before mode switching.
Magnet Response in Standard Program
Details magnet response settings (Asynchronous, Automatic, Synchronous) in the standard program.
Patient Magnet Application Guidelines
Advises patients on when and how to use magnet application for synchronous response.
Follow-up
Follow-up Intervals and Programmer Use
Specifies recommended intervals for follow-ups and the procedure using the programmer.
Follow-up with BIOTRONIK Home Monitoring
Explains how Home Monitoring supports follow-up but does not replace in-office appointments.
Patient Information
Patient ID Card and Prohibitive Signs
Mentions the patient ID card and advises avoiding premises with prohibitive signs.
Possible Sources of Interference
Warns about daily interference sources and provides instructions for patients.
Replacement Indications
Charging Status and ERI Activation/Display
Lists factors for ERI, activation triggers, and how ERI is displayed.
Rate Decrease and Mode Change at ERI
Details rate decrease and mode changes that occur when ERI is reached.
Deactivated Functions and Magnet Response at ERI
Lists functions deactivated at ERI and describes magnet response behavior.
Expected Service Times After ERI
Provides information on expected service times after ERI based on various settings.
Explantation and Device Replacement
Explantation and Device Replacement Procedures
Details lead disconnection, device removal, and replacement of leads.
Cremation and Disposal Guidelines
States devices should not be cremated and outlines environmentally safe disposal.
Parameters
Timing Parameters
Details timing parameters like basic rate, night rate, and AV delay.
Rate Hysteresis and AV Hysteresis
Explains hysteresis parameters for rate and AV delay adjustments.
Ventricular Pacing and Upper Rate Settings
Lists parameters for ventricular pacing, triggering, and upper rate limits.
Mode Switching and VP Suppression
Covers mode switching parameters and ventricular pacing suppression.
Refractory, Blanking Periods, and PMT Protection
Details refractory periods, blanking periods, and PMT protection settings.
Pacing and Sensing
Pulse Amplitude, Pulse Width, and Sensitivity
Specifies ranges for pulse amplitude, pulse width, and sensitivity settings.
Atrial and Ventricular Capture Control
Lists parameters for atrial and ventricular capture control, including safety margins.
Atrial Overdrive Pacing
Describes the function and parameters of atrial overdrive pacing.
Lead Configuration Settings
Details lead polarity settings for sensing and pacing for different device types.
IEGM Recordings and Statistics
Covers parameters for IEGM recordings and statistical rate monitoring.
Rate Adaptation
CLS Modes: Closed Loop Stimulation
Lists parameters for CLS modes, including maximum rate, response, and resting rate control.
R Modes: Accelerometer Parameters
Lists parameters for R modes using accelerometer, like sensor gain and rate fading.
MRI Program
MRI Modes and Expiration Dates
Details valid modes for ProMRI devices, including MRI program and expiration settings.
Preset MRI Program Parameters
Lists preset parameters for the MRI program, such as basic rate and AV delay.
Preset Programs
Standard and Safe Programs Post-Initialization
Shows modes after auto-initialization and lead configuration settings.
Parameters After Auto-Initialization
Lists parameters like basic rate, night rate, and hysteresis for auto-initialization.
Refractory Periods and Mode Switching
Details refractory periods, mode switching, and capture control parameters.
Home Monitoring and IEGM Settings
Covers Home Monitoring and IEGM recording settings for preset programs.
Tolerances of Parameter Values
Rate and Amplitude Tolerances
Lists tolerances for basic rate, pulse amplitude, and pulse width.
Sensitivity and Refractory Period Tolerances
Details tolerances for sensitivity, refractory period, and maximum activity rate.
Lead Impedance Tolerances
Specifies tolerance for lead impedance measurements.
Technical Data
Mechanical Characteristics of the Housing
Provides measurements for the device housing (W x H x D, volume, mass).
X-ray Identification and Body Contact Materials
Explains X-ray identification logo and materials in contact with body tissue.
Electrical Characteristics
Details electrical characteristics like circuit technology, impedance, pulse form, and polarity.
Telemetry Data and Radio Certification
Lists telemetry data and international radio certification information.
Pulse Form and Interference Resistance
Illustrates the pacing pulse form and states resistance to interference compliance.
Battery Data
Battery Characteristics and Manufacturers
Provides battery data from manufacturers like GB 3193 and LiS 2650MK.
Service Time Impact and Power Consumption
Explains service time impact from storage and lists power consumption figures.
Calculation and Mean Service Times (SR/DR)
Outlines factors for calculating service times and provides mean times for SR/DR devices.
Mean Service Times (HF)
Provides average service times for triple-chamber (HF) devices based on settings.
Legend for the Label
Label Icons and Their Meanings
Explains various icons found on device labels and their symbolic meanings.
Need help?
Do you have a question about the Enitra 8 Series and is the answer not in the manual?
Questions and answers