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BIOTRONIK Manuals
Portable Generator
Evia DR-T
Technical manual
BIOTRONIK Evia DR-T Technical Manual
Family of implantable pulse generators
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Contents
Table of Contents
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Table of Contents
Table of Contents
1 Device Description
2 Indications
3 Contraindications
4 Warnings and Precautions
Medical Therapy
Storage and Sterilization
Lead Connection and Evaluation
Programming and Operation
Home Monitoring
Electromagnetic Interference (EMI)
Home and Occupational Environments
Cellular Phones
Hospital and Medical Environments
Pulse Generator Explant and Disposal
5 Adverse Events
Observed Adverse Events
Dromos DR Clinical Study
PACC Clinical Study
Inos2+ CLS Clinical Study
Potential Adverse Events
6 Clinical Study
Dromos DR
Ventricular Capture Control
Primary Objectives
Methods
Results
Clinical Study Conclusions
Closed Loop Stimulation (CLS)
Protos DR/CLS Response to Mental Stress
Protos DR CLS with Axvx
Inos CLS
TRUST Clinical Study
Study Overview
Methods
Summary of Clinical Results
Conclusions
7 Programmable Parameters
Pacing Modes
Motion Based Rate-Adaptive Modes
CLS Modes
Non-Rate-Adaptive Modes
Mode Switching
Pacing Modes with Triggered Response
Rate Related Functions
Basic Rate
Rate Hysteresis
Scan Hysteresis
Repetitive Hysteresis
Night Mode
Rate Fading
Pulse Specific Features
Pulse Amplitude
Pulse Width
Automatic Sensitivity Control (ASC)
Timing Features
Refractory Periods
Pvarp
AV Delay
Ventricular Blanking Period
Atrial Blanking Period
Far-Field Protection
Safety AV Delay
Upper Rate and UTR Response
Lead Polarity
Parameters for Rate-Adaptive Pacing
Sensor Gain
Automatic Sensor Gain
Sensor Threshold
Rate Increase
Maximum Sensor Rate
Maximum Closed Loop Rate
Rate Decrease
Management of Specific Scenarios
2:1 Lock-In Management
Atrial Upper Rate
Atrial Overdrive Pacing (Overdrive Mode)
Management of Specific Scenarios
PMT Management
PMT Protection
Adjustment of the PMT Protection Window
Ventricular Capture Control (VCC)
Feature Description
Ventricular Capture Control Programming
Program Consult
Home Monitoring (Evia DR-T)
Transmission of Information
Patient Device
Transmitting Data
Types of Report Transmissions
Description of Transmitted Data
8 Statistics
Statistics Overview
Timing
Atrial Arrhythmia
Sensor
Sensing
Ventricular Arrhythmia
Pacing
General Statistical Information
Timing Statistics
Event Counter
Event Episodes
Rate Trend 24 Hours
Rate Trend 240 Days
Atrial and Ventricular Rate Histogram
Arrhythmia Statistics
Atrial Burden
Time of Occurrence
Mode Switching
Ventricular Arrhythmia
Sensor Statistics
Sensor Histogram
Activity Report
Pacing Statistics
Ventricular Pacing Amplitude Histogram
Pacing Threshold Trend
Capture Control Status
Sensing Statistics
IEGM Snapshots
9 Other Functions/Features
Safe Program Settings
Magnet Effect
Temporary Programming
Patient Data Memory
Position Indicator
Pacing When Exposed to Interference
10 Product Storage and Handling
Sterilization and Storage
Opening the Sterile Container
Pulse Generator Orientation
11 Lead Connection
Auto Initialization
12 Follow-Up Procedures
General Considerations
Real-Time IEGM Transmission
Threshold Test
P/R Measurement
Testing for Retrograde Conduction
Non-Invasive Programmed Stimulation (NIPS)
Description
Burst Stimulation
Programmed Stimulation
Back up Pacing
NIPS Safety Features
Optimizing Rate Adaptation
Rate/Sensor Trend
Adjusting the Sensor Gain
Adjusting the Sensor Threshold
13 Elective Replacement Indication (ERI)
14 Explantation
Common Reasons to Explant a Pulse Generator
15 Technical Data
Modes
Pulse- and Control Parameters
Rate Adaptation
Ventricular Capture Control (VCC)
Home Monitoring Parameters
Additional Functions
NIPS Specifications
Programmer
Materials in Contact with Human Tissue
Electrical Data/Battery
Mechanical Data
16 Order Information
Appendix A
Appendix B
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1
Device Description
2
Contraindications
3
Electromagnetic Interference (Emi)
4
Hospital and Medical Environments
5
Magnet Effect
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Evia
Family of Implantable Pulse Generators
Technical Manual
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This manual is also suitable for:
Evia dr
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Evia sr-t
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