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BIOTRONIK ICD Series User Manual

BIOTRONIK ICD Series
48 pages
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Iforia
ICD Family • Tachyarrhythmia Therapy • Cardiac Resynchronization Therapy
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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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393467--B_GA_Iforia-I-ProMRI_mul-01xx_Cover.indd 1 25.10.2012 17:51:48
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BIOTRONIK ICD Series Specifications

General IconGeneral
Device TypeImplantable Cardioverter Defibrillator (ICD)
ManufacturerBIOTRONIK
CommunicationBIOTRONIK Home Monitoring
Battery LongevityUp to 10 years depending on usage
Pacing TherapyYes
Therapy OptionsATP, Cardioversion, Defibrillation, Bradycardia Pacing
Remote MonitoringBIOTRONIK Home Monitoring
MRI CompatibilitySome devices are MRI conditional. Check specific model for MRI compatibility.
SizeVaries by model
Lead CompatibilityCompatible with BIOTRONIK leads and industry-standard leads

Summary

Product Description and System Overview

Intended Use, Indications, and Contraindications

Defines the device's purpose, patient suitability, and limitations for therapy.

System Overview and Device Family

Describes the overall device family, its components, and general system structure.

Device Details and Telemetry

Device Housing and Lead Connections

Details the device's physical characteristics and connection types like DF-1/IS-1.

Telemetry, Programmer, and Modes

Explains telemetric communication, programmer function, and operating modes.

Technical Information and Manuals

Technical Manuals and Order Numbers

Lists available technical manuals and product order information.

Scope of Delivery and Therapeutic Functions

Scope of Delivery and Diagnostic Functions

Lists included items and diagnostic capabilities like impedance measurement.

Therapeutic Functions Overview

Covers cardioversion, defibrillation, ATP, and antibradycardia pacing.

Safety Instructions and Complications

General Safety and Operating Conditions

Covers safe handling, storage, and operating conditions for the device.

Possible Complications and Technical Failures

Lists potential issues, failure modes, and patient risks associated with the device.

Risk Procedures and Environmental Considerations

Contraindicated and Risky Procedures

Details procedures that are contraindicated or carry risks to the patient or device.

Electromagnetic Interference and Radiation

Discusses effects of EMI, external defibrillation, and radiation therapy on the device.

Implantation and Programming

Implantation Procedure Steps

Provides a step-by-step guide for implanting the device and connecting leads.

Programming and Telemetry Contact

Explains how to establish contact and program the device using the programmer.

Patient Monitoring and Parameter Settings

Monitoring Patient and Setting Sensing

Covers patient monitoring during asynchronous modes and setting sensitivity.

Preventing Complications and Shock Impedance

Discusses functions to prevent complications and shock impedance limits.

Follow-up Procedures

In-Office Follow-up

Details the steps for in-office follow-up examinations and data evaluation.

Home Monitoring Follow-up

Explains how Home Monitoring supports patient follow-up and data transmission.

Prohibitory Signs and Interference Sources

Prohibitory Signs and Patient Instructions

Advises on avoiding places with prohibitory signs and patient actions.

Sources of Interference and Cell Phone Use

Identifies interference sources and provides guidelines for cell phone use.

Replacement Indications and Battery Data

Battery Replacement Indications

Explains battery status levels (BOS, MOS, EOS) and indications for replacement.

Battery Characteristics and Service Times

Provides battery specifications and calculated service times based on usage.

Device Explantation and Replacement

Explantation Procedure

Details steps for safely removing the device from the patient.

Device Replacement Considerations

Outlines precautions for replacing the device, including lead management.

Device Parameters and Settings

Bradycardia/CRT Parameters

Lists parameters related to bradycardia and cardiac resynchronization therapy.

Timing Parameters

Details timing parameters like AV delay and rate hysteresis.

Tachycardia Therapy Parameters

Tachycardia Detection Parameters

Covers parameters for detecting VT1, VT2, and VF.

Antitachycardia Pacing (ATP) and Shock Therapy

Details ATP types, optimization, and shock energy settings.

Sensing and Diagnostics Parameters

Sensing Sensitivity and Thresholds

Describes sensitivity settings and threshold parameters for sensing.

Diagnostic Settings and Measurements

Covers diagnostic parameters like AT/AF, SVT, and periodic recording.

Rate Adaptation and Pacing Parameters

Rate Adaptation Parameters

Details parameters for automatic rate adaptation via accelerometer.

Pacing Amplitude and Pulse Width

Specifies parameters for pacing pulse amplitude and width.

Shock Energy and Pulse Form Parameters

Shock Energy and Peak Voltage

Details shock energy levels and peak voltages for different shock paths.

Common Mode Rejection and ATP Amplitude

Provides data on common mode rejection ratios and ATP amplitude measurements.

Technical Data and Electrical Characteristics

Home Monitoring and IEGM Settings

Covers settings for Home Monitoring and IEGM data transmission.

Electrical Characteristics and Standards

Lists electrical specifications, measurement conditions, and relevant standards.

Battery Performance Calculations

Longevity Calculations for Shocks

Presents calculations for device longevity based on shock frequency and stimulation.

Labeling Legend and Symbols

Package and Device Label Icons

Explains the meaning of various icons found on the device and package labels.

Sterilization and Handling Symbols

Details symbols related to sterilization, single-use, and packaging integrity.

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