BIOTRONIK Ilesto 7 HF-T Technical Manual

BIOTRONIK Ilesto 7 HF-T Technical Manual

Tachyarrhythmia therapy / cardiac resynchronization therapy

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Ilesto
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ICD Familie • Tachyarrhythmietherapie • Kardiale Resynchronisationstherapie
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Technical Manual
Technická příručka
Brugermanual
Gebrauchsanweisung
Manual técnico
Käyttöohje
Manuel technique
Manuale tecnico di istruzione
Gebruikshandleiding
Instrukcja obsługi
Manual técnico
Bruksanvisning
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Table of Contents
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Summarization of Contents

Product Description
Intended Medical Use and Therapy Forms
Primary objective is to prevent sudden cardiac death and treat arrhythmias; device monitors heart rhythm.
Indications and Contraindications
Lists criteria for device use (indications) and conditions where it should not be used (contraindications).
Required Expertise for Operation
Users must have basic medical knowledge and be familiar with device operation and conditions.
System Overview
Device Family and Lead Connections
Ilesto 5/7 family types, DF-1/IS-1 and DF4/IS-1 lead connections, configuration, and implantation sites.
Device Housing, Leads, and Telemetry
Biocompatible titanium housing, sealed, ellipsoid shape; information on leads, telemetry, and programmer.
Pacing Modes and Codes
Mode settings (VR, DX, DR, HF); definitions of NBD and NBG pacing codes.
General Safety Instructions
Operating Conditions and Storage
Guidelines for temperature, shipping, storage, and delivery in shipment mode.
Potential Complications, Risks, and Contraindications
Discusses complications, risks, contraindications, and hazards from procedures like MRI, radiation, defibrillation.
Electromagnetic Interference and Magnetic Fields
Device sensitivity to EMI and behavior in static magnetic fields.
Implantation
Implantation Procedure and Preparation
Steps for preparing parts, unpacking, checking components, and connecting leads to the device.
Safety Precautions During Implantation
Preventing shock delivery, header damage, short circuits, and ensuring clean connections.
Programming and Follow-up Procedures
Measures during programming, follow-up intervals, and use of BIOTRONIK Home Monitoring.
Replacement Indications and Device Management
Battery levels, ERI/EOS indications, device replacement, explantation, and disposal.
Parameters
Bradycardia, CRT, and AV Timing Settings
Parameters for bradycardia/CRT therapy, basic rate, AV delay, and hysteresis.
Tachycardia Detection, ATP, and Shock Therapy
Parameters for VT/VF detection, ATP, and shock energy, polarity, and waveform.
Sensing Parameters and Diagnostics
Parameters for sensing thresholds, diagnostics settings, and IEGM configuration.
Home Monitoring Settings
Parameters for enabling Home Monitoring, time of transmission, and IEGM data for episodes.
Technical Data
Mechanical Characteristics
Housing dimensions, volume, mass, materials in contact with body tissue, and X-ray identification.
Electrical Characteristics and Telemetry
Specifications, measuring conditions, factory settings, radio certification, and telemetry data.
Battery Data and Service Lifespan
Information on battery type, capacity, storage, and calculated service times based on stimulation.
Labeling Legend and Connector Types
Explanation of symbols on device labels and diagrams of lead connector types.

Table of Contents