User Manuals: BIOTRONIK Evia SR Pulse Generator

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BIOTRONIK Evia SR Technical Manual

BIOTRONIK Evia SR Technical Manual (183 pages)

Family of Implantable Pulse Generators

Brand: BIOTRONIK | Category: Portable Generator | Size: 0 MB

Table of Contents

Table of Contents
3
1 Device Description

9
2 Indications

12
3 Contraindications

14
4 Warnings and Precautions

16
- Medical Therapy
  16
- Storage and Sterilization
  18
- Lead Connection and Evaluation
  18
- Programming and Operation
  20
- Home Monitoring
  22
- Electromagnetic Interference (EMI)
  23
- Pulse Generator Explant and Disposal
  27
5 Adverse Events

29
- Observed Adverse Events
  29
  - Dromos DR Clinical Study
    29
  - PACC Clinical Study
    31
  - Inos2+ CLS Clinical Study
    32
- Potential Adverse Events
  34
6 Clinical Study

35
- Dromos DR
  35
- Ventricular Capture Control
  36
  - Primary Objectives
    37
  - Methods
    37
  - Results
    37
  - Clinical Study Conclusions
    42
- Closed Loop Stimulation (CLS)
  43
  - Protos DR/CLS Response to Mental Stress
    43
  - Protos DR CLS with Axvx
    46
  - Inos CLS
    49
- TRUST Clinical Study
  52
  - Study Overview
    52
  - Methods
    53
  - Summary of Clinical Results
    55
  - Conclusions
    59
7 Programmable Parameters

61
- Pacing Modes
  61
  - Motion Based Rate-Adaptive Modes
    61
  - CLS Modes
    61
  - Non-Rate-Adaptive Modes
    62
  - Mode Switching
    63
  - Pacing Modes with Triggered Response
    64
- Rate Related Functions
  65
  - Basic Rate
    65
  - Rate Hysteresis
    66
  - Scan Hysteresis
    67
  - Repetitive Hysteresis
    68
  - Night Mode
    69
  - Rate Fading
    70
- Pulse Specific Features
  71
  - Pulse Amplitude
    71
  - Pulse Width
    72
- Automatic Sensitivity Control (ASC)
  72
- Timing Features
  73
  - Refractory Periods
    73
  - Pvarp
    73
  - AV Delay
    75
  - Ventricular Blanking Period
    79
  - Atrial Blanking Period
    80
  - Far-Field Protection
    80
  - Safety AV Delay
    80
  - Upper Rate and UTR Response
    81
- Lead Polarity
  81
- Parameters for Rate-Adaptive Pacing
  82
  - Sensor Gain
    83
  - Automatic Sensor Gain
    84
  - Sensor Threshold
    85
  - Rate Increase
    86
  - Maximum Sensor Rate
    87
  - Maximum Closed Loop Rate
    87
  - Rate Decrease
    88
- Management of Specific Scenarios
  89
  - 2:1 Lock-In Management
    89
- Atrial Upper Rate
  90
- Atrial Overdrive Pacing (Overdrive Mode)
  91
- Management of Specific Scenarios
  92
  - PMT Management
    92
  - PMT Protection
    93
- Adjustment of the PMT Protection Window
  94
- Ventricular Capture Control (VCC)
  95
  - Feature Description
    95
  - Ventricular Capture Control Programming
    104
- Program Consult
  105
- Home Monitoring (Evia DR-T)
  109
  - Transmission of Information
    110
  - Patient Device
    110
  - Transmitting Data
    111
  - Types of Report Transmissions
    113
  - Description of Transmitted Data
    114
8 Statistics

117
- Statistics Overview
  117
  - Timing
    117
  - Atrial Arrhythmia
    117
  - Sensor
    117
  - Sensing
    118
  - Ventricular Arrhythmia
    118
  - Pacing
    118
  - General Statistical Information
    118
- Timing Statistics
  119
  - Event Counter
    119
  - Event Episodes
    120
  - Rate Trend 24 Hours
    120
  - Rate Trend 240 Days
    120
  - Atrial and Ventricular Rate Histogram
    121
- Arrhythmia Statistics
  121
  - Atrial Burden
    121
  - Time of Occurrence
    121
  - Mode Switching
    121
  - Ventricular Arrhythmia
    122
- Sensor Statistics
  122
  - Sensor Histogram
    122
  - Activity Report
    123
- Pacing Statistics
  123
  - Ventricular Pacing Amplitude Histogram
    124
  - Pacing Threshold Trend
    124
  - Capture Control Status
    125
- Sensing Statistics
  125
- IEGM Snapshots
  126
9 Other Functions/Features

129
- Safe Program Settings
  129
- Magnet Effect
  129
- Temporary Programming
  130
- Patient Data Memory
  131
- Position Indicator
  132
- Pacing When Exposed to Interference
  133
10 Product Storage and Handling

134
- Sterilization and Storage
  134
- Opening the Sterile Container
  135
- Pulse Generator Orientation
  136
11 Lead Connection

138
- Auto Initialization
  141
12 Follow-Up Procedures

144
- General Considerations
  144
- Real-Time IEGM Transmission
  145
- Threshold Test
  145
- P/R Measurement
  146
- Testing for Retrograde Conduction
  147
- Non-Invasive Programmed Stimulation (NIPS)
  147
  - Description
    147
  - Burst Stimulation
    148
  - Programmed Stimulation
    148
  - Back up Pacing
    148
  - NIPS Safety Features
    149
- Optimizing Rate Adaptation
  150
  - Rate/Sensor Trend
    150
  - Adjusting the Sensor Gain
    151
  - Adjusting the Sensor Threshold
    151
13 Elective Replacement Indication (ERI)

153
14 Explantation

157
- Common Reasons to Explant a Pulse Generator
  157
15 Technical Data

161
- Modes
  161
- Pulse- and Control Parameters
  162
  - Rate Adaptation
    165
  - Ventricular Capture Control (VCC)
    166
  - Home Monitoring Parameters
    166
  - Additional Functions
    168
  - NIPS Specifications
    169
- Programmer
  169
- Materials in Contact with Human Tissue
  169
- Electrical Data/Battery
  169
- Mechanical Data
  171
16 Order Information

172
Appendix A

174
Appendix B

180

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