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BIOTRONIK Evia DR-T User Manual

BIOTRONIK Evia DR-T
183 pages
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Evia
Family of Implantable Pulse Generators
Technical Manual

Table of Contents

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BIOTRONIK Evia DR-T Specifications

General IconGeneral
ManufacturerBIOTRONIK
ModelEvia DR-T
CategoryPortable Generator
TypeDual Chamber
MRI ConditionalYes
Rate ResponseYes
ProgrammabilityYes
TelemetryYes
TherapyPacing
Battery TypeLithium

Summary

4. Warnings and Precautions

4.1 Medical Therapy

Precautions and considerations for therapeutic procedures.

4.4 Programming and Operation

Instructions for programming parameters and operating the device.

4.6 Electromagnetic Interference (EMI)

Information on potential EMI sources and effects on the device.

5. Adverse Events

5.1 Observed Adverse Events

Summary of adverse events from clinical studies.

6. Clinical Study

7. Programmable Parameters

7.1 Pacing Modes

Overview of available pacing modes and configurations.

7.2 Rate Related Functions

Parameters controlling rate-related functions of the pacemaker.

7.3 Pulse Specific Features

Features related to the pulse amplitude and width.

7.4 Automatic Sensitivity Control (ASC)

Function for automatic adjustment of sensing sensitivity.

7.5 Timing Features

Features related to pulse generator timing cycles.

7.7 Parameters for Rate-Adaptive Pacing

Parameters used to tailor motion-based rate adaptation.

7.13 Ventricular Capture Control (VCC)

Feature for automatic capture threshold measurement.

7.13.2 Ventricular Capture Control Programming

Programming options for VCC (ON, ATM, OFF).

7.15 Home Monitoring (Evia DR-T)

Information exchange for patient status and device function.

8. Statistics

9. Other Functions/Features

9.6 Pacing When Exposed to Interference

How the device responds to electromagnetic interference.

10. Product Storage and Handling

11. Lead Connection

11.1 Auto Initialization

Automatic detection and configuration of connected leads.

12. Follow-up Procedures

12.3 Threshold Test

Procedure for testing capture threshold and safety margins.

12.7 Optimizing Rate Adaptation

Checking and adjusting rate adaptation parameters.

13. Elective Replacement Indication (ERI)

14. Explantation

15. Technical Data

15.1 Modes

List of available pacing modes for Evia models.

15.2 Pulse- and Control Parameters

Range of values for pulse and control parameters.

Appendix A

Mode-Specific Indications and Contraindications

Indications and contraindications for various pacing modes.

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