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Evia Function Manual
Evia Pacemaker Family
Doc. Id.: 365350--D
Index 365350-AEvia Function Manual
2
3 Table of Contents
Table of Contents
Table of Contents
Characteristics of the Evia Pacemaker Family . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Device Variants and NBG Codes. . . . . . . . . . . . . . . . . . . . . . 13
Diagnostic and Therapy Functions . . . . . . . . . . . . . . . . . . . . 14
Replacement Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Functional Description and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Auto-initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Auto-initialization of the device . . . . . . . . . . . . . . . . . . . . . . 20
Lead Configuration and Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Automatic Lead Impedance Measurement and Check. . . . 22
Lead Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Setting Lead Polarity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Sensing Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Sensing Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Automatic Sensitivity Control . . . . . . . . . . . . . . . . . . . . . . . . 29
Interference Interval as Interference Protection . . . . . . . . 32
Sensitivity - Manual Setting or Automatic Regulation . . . . 32
Bradycardia Therapy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Pacing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Pacing Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Standard Pacing Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Summary of the Functions and Time Intervals of
the Pacing Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Rate-Adaptive Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Pacing when Exposed to Interference . . . . . . . . . . . . . . . . . 43
Setting the Magnet Response. . . . . . . . . . . . . . . . . . . . . . . . 44
Pacing Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Pulse Amplitude and Pulse Width . . . . . . . . . . . . . . . . . . . . 47
Setting Pulse Amplitude and Pulse Width. . . . . . . . . . . . . . 47
Basic Rate during the Day and at Night . . . . . . . . . . . . . . . . 49
Setting the Basic Rate for Day and Night. . . . . . . . . . . . . . . 50
4 Table of Contents
Timing Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Programs and Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Setting and Transmitting Parameters . . . . . . . . . . . . . . . . . 53
ProgramConsult - Default Settings for
Clinical Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Creating and Using Individual Therapy Programs . . . . . . . 65
Functions of Rate Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Rate Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Repetitive Rate Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Scan Rate Hysteresis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Setting Rate Hystereses . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Functions of the Dynamic AV Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Dynamic AV Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Setting the Dynamic AV Delay. . . . . . . . . . . . . . . . . . . . . . . . 74
EasyAV - Tool for Optimizing the AV Delay . . . . . . . . . . . . . 77
AV Safety Delay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Sense Compensation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
AV Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
AV Repetitive Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
AV Scan Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Negative AV Hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Setting AV Hystereses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
The Concept of Ventricular Pacing Suppression. . . . . . . . . 86
How Ventricular Pacing Suppression Works. . . . . . . . . . . . 87
Setting Ventricular Pacing Suppression . . . . . . . . . . . . . . . 94
IRSplus - Promoting Intrinsic AV Conduction . . . . . . . . . . . 95
Refractory and Blanking Times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Timing of the Atrial Refractory Times (ARP, PVARP) . . . . . 97
Setting the Blanking and Refractory Periods . . . . . . . . . . 100
Atrial and Ventricular Capture Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Atrial capture control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Atrial Capture Control - Overview . . . . . . . . . . . . . . . . . . . 104
Automatic Threshold Measurement. . . . . . . . . . . . . . . . . . 105
Ventricular Capture Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Ventricular Capture Control - Overview. . . . . . . . . . . . . . . 112
Signal Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Automatic Threshold Measurement. . . . . . . . . . . . . . . . . . 117
Verification of Stimulus Response . . . . . . . . . . . . . . . . . . . 119
Configuring Capture Control, Parameters, and FAQ . . . . . . . . . . . . . 121
Setting Atrial and Ventricular Capture Control . . . . . . . . . 122
Ven. und atr. Capture Control - Programmable
Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
FAQ - Frequently Asked Questions . . . . . . . . . . . . . . . . . . 126
Comparison of Atrial and Ventricular Capture Control . . 128
5 Table of Contents
Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Pacing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Rate-Adaptive Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Physiological Rate Adaptation (CLS Function) . . . . . . . . . . . . . . . . . . 132
The Closed Loop Stimulation Principle . . . . . . . . . . . . . . . 133
Individual Adjustment of CLS Parameters . . . . . . . . . . . . 134
CLS Safety Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Setting Closed Loop Stimulation . . . . . . . . . . . . . . . . . . . . 136
Rate Adaptation Using the Accelerometer . . . . . . . . . . . . . . . . . . . . . 139
The Principle of Rate Adaptation via Accelerometer . . . . 140
Maximum Activity Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Sensor Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Automatic Sensor Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Sensor Threshold. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Rate Increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Rate Decrease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Sensor Simulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Rate Fading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Setting Rate Adaptation and Sensor/Rate Fading
Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Antitachycardia Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Setting the Upper Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Atrial Upper Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
Tachycardia Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
Mode Switching . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Setting Mode Switching. . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
2:1 Lock-In Management . . . . . . . . . . . . . . . . . . . . . . . . . . 160
PMT Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
PMT Protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Setting PMT Protection and VA Criterion. . . . . . . . . . . . . . 164
AV Control Window as PVC Lock-in Protection. . . . . . . . . 166
Atrial Overdrive Pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Setting Overdrive Pacing. . . . . . . . . . . . . . . . . . . . . . . . . . . 168
Patient Data and Diagnostics/HM Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Parameters: Patient Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . 170
Parameters: Home Monitoring/Diagnostics Tab . . . . . . . 171
Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Home Monitoring Parameters . . . . . . . . . . . . . . . . . . . . . . 176
Types of Device Messages. . . . . . . . . . . . . . . . . . . . . . . . . . 177
Criteria for the Use of Home Monitoring . . . . . . . . . . . . . . 178
Periodic IEGM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
6 Table of Contents
Evaluating Holter Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
Displaying IEGM Recordings (Holter). . . . . . . . . . . . . . . . . 182
Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Statistics General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
Selecting Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Evaluating Statistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Displaying Timing Statistics . . . . . . . . . . . . . . . . . . . . . . . . 188
Displaying Arrhythmia Statistics . . . . . . . . . . . . . . . . . . . . 190
Displaying Sensor Statistics . . . . . . . . . . . . . . . . . . . . . . . . 191
Displaying Sensing Statistics . . . . . . . . . . . . . . . . . . . . . . . 192
Displaying Pacing Statistics . . . . . . . . . . . . . . . . . . . . . . . . 193
System Functions of the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
Reading out Device Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
Performing Automatic Follow-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
The Follow-up Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
Real-time IEGM on the Software Interface . . . . . . . . . . . . 201
Configuring and Performing Automatic Follow-up. . . . . . 202
Archive - Events - Measured Value Trends . . . . . . . . . . . . . . . . . . . . . . 204
Event List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Archiving Follow-up Results. . . . . . . . . . . . . . . . . . . . . . . . 206
TrendView - Overview of Important Measured
Value Trends of the Device . . . . . . . . . . . . . . . . . . . . . . . . . 207
Performing Manual Follow-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210
Manual Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Overview of Manual Follow-up Tests . . . . . . . . . . . . . . . . . 212
Sensing Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
Description of the P/R Amplitudes Sensing Test . . . . . . . 214
Performing the P/R Amplitudes Sensing Test . . . . . . . . . 215
Threshold Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
Description of the Threshold Test . . . . . . . . . . . . . . . . . . . 218
Conducting the Threshold Test. . . . . . . . . . . . . . . . . . . . . . 219
Threshold Test Parameters. . . . . . . . . . . . . . . . . . . . . . . 223
Retrograde Conduction Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
Retrograde Conduction Test . . . . . . . . . . . . . . . . . . . . . . . . 226
Conducting the Retrograde Conduction Test . . . . . . . . . . 227
Sensor Optimization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
Sensor Optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
7 Table of Contents
NIPS - Non-Invasive Programmed Stimulation. . . . . . . . . . . . . . . . . . . . . . . . . . . 232
NIPS - External Pulse Control . . . . . . . . . . . . . . . . . . . . . . 233
NIPS - Selecting Therapy and Setting Parameters . . . . . 234
NIPS - Description of Burst Stimulation . . . . . . . . . . . . . . 235
NIPS - Executing Burst Stimulation. . . . . . . . . . . . . . . . . . 236
NIPS - Description of Programmed Stimulation. . . . . . . . 239
NIPS - Executing Programmed Stimulation . . . . . . . . . . . 241
ProMRI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
MRI Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
Target Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
An Overview of MR Conditional BIOTRONIK Products . . . 248
Magnetic Resonance Imaging - Possible Interactions . . . 250
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Preconditions and Basic Conditions for all Products . . . . 252
Conditions for Specific Products . . . . . . . . . . . . . . . . . . . . 253
Preliminary Examination. . . . . . . . . . . . . . . . . . . . . . . . . . . 255
MRI Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
MR Conditional Symbol on the Label . . . . . . . . . . . . . . . . 257
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258
Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
Pacing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260
Timing: Dual-chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261
Timing: Single-chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . 263
Pacing and sensing: Dual-chamber. . . . . . . . . . . . . . . . . . 264
Pacing and sensing: Single-chamber . . . . . . . . . . . . . . . . 266
Rate Adaptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Preset Programs: Dual-chamber. . . . . . . . . . . . . . . . . . . . 268
Preset Programs: Single-chamber . . . . . . . . . . . . . . . . . . 269
Tolerances of Parameter Values . . . . . . . . . . . . . . . . . . . . 270
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272
Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . 273
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . 274
Battery Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . 278
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
8 Table of Contents
9
I Characteristics of the
Evia Pacemaker Family
Characteristics of the Evia Pacemaker FamilyI365350-AEvia Function Manual
What's in this part? This part contains the following chapters:
Overview You will find a description of the Evia pacemaker family in part I of the function
manual.
Chapter Chapter name Page
1 System Description 10
10
1 System Description
System Description1365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Intended Medical Use 11
System Overview 12
Device Variants and NBG Codes 13
Diagnostic and Therapy Functions 14
Replacement Indications 16
11 System Description
Intended Medical Use
Intended use Evia is a family of implantable pacemakers that may be implanted for all brady-
cardia arrhythmia indications. The primary objective of the therapy consists of
improving patients' symptoms that can be clinically manifested.
The implantation of the pacemaker is a symptomatic therapy with the following
objective:
Compensation of bradycardia by atrial, ventricular, or AV sequential pacing
Diagnosis and
therapy forms
The cardiac rhythm is automatically monitored and bradycardia arrhythmias are
treated. All major therapeutic approaches from the field of cardiology and electro-
physiology are unified in the Evia family.
BIOTRONIK Home monitoring

enables physicians to perform therapy manage-


ment any time.
Required expertise In addition to having basic medical knowledge, the user must be thoroughly
familiar with the operation of a device system. Only qualified medical specialists
having the special knowledge required for the proper use of devices are permitted
to use them. If users do not possess this knowledge, they must be trained accord-
ingly.
12 System Description
System Overview
Parts The device system consists of the following parts:
Device with connections for unipolar or bipolar sensing and pacing
Suitable leads, adapters and approved accessories
Programmer
Current device programs
Device The device's housing is made of biocompatible titanium, welded from outside and
thus hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral
muscle area.
The housing serves as an antipole in the case of unipolar lead configuration.
BIOTRONIK provides silicone-coated devices to avoid muscle twitching near the
implanted pacemaker in the case of unipolar pacing.
The labeling provides information about the device type and arrangement of the
connections.
Leads The leads are coated with biocompatible silicone. They can be flexibly maneuvered,
are stable long-term, and are equipped for active or passive fixation. They are
implanted using a lead introducer set. Some leads are coated with polyurethane to
increase the sliding properties of the lead.
The coating of steroid-eluting leads reduces inflammatory processes. The fractal
design of the leads provides for low pacing thresholds, high pacing impedance, and
a low risk of oversensing.
Programmer The portable programmer is used to transfer the current device program to the
device. In addition to this, the programmer is used for interrogation and storage
of data from the device. The programmer acts as an ECG and IEGM monitor with
Miniclinic.
The programmer communicates with the device via the programming head.
It has a TFT touch screen with a color display, on which the ECG, IEGM, marker and
functions are shown simultaneously.
The programmer has, among others, the following functions:
Perform all tests during in-office follow-up
Display and print real-time and saved IEGMs with annotated markers
Determine the pacing threshold
BIOTRONIK
Home Monitoring

In addition to effective pacing therapy, BIOTRONIK provides a complete therapy


management system:
With Home Monitoring, diagnostic and therapeutic information and technical
data are automatically sent to a stationary or mobile transmitter via an antenna
in the device header. The data are encrypted and sent from the transmitter to
the BIOTRONIK Service Center via the cellular phone network.
The received data are deciphered and evaluated. Each physician can set the
criteria for evaluation to be used for each patient and can configure the time of
notification via E-mail, SMS or fax.
A clear overview of the analysis results is displayed for the attending physicians
on the protected Internet platform HMSC (Home Monitoring Service Center).
Data transmission from the device is performed on a daily basis with the device
message. Depending on the transmitter used, these data are passed on imme-
diately or, if the data is normal, it is collected for up to 2 weeks.
Device messages, which indicate special events in the patient's heart or in
the device, are forwarded immediately.
13 System Description
Technical manuals The following technical manuals provide information about usage of the device
system:
Technical manual for the device
Technical manual for the HMSC
Technical manual for the programmer
User manual for the device program:
As a help function in the user interface
As a file on CD
Technical manual for the leads
Technical manual for cables, adapters and accessories
Device Variants and NBG Codes
Evia family The following device variants are available:
NBG-Code for Evia DR(-T) The NBG code for dual-chamber devices is DDDR:
NBG-Code for Evia SR(-T) The NBG code for single-chamber devices is AAIR or VVIR:
Device type Variant with
Home Monitoring
Variant without
Home Monitoring
Dual-chamber Evia DR-T Evia DR
Single-chamber Evia SR-T Evia SR
Note: The setting of the pacing mode depends on the individual diagnosis;
the modes are listed in the section pertaining to adjustable parameters.
D Pacing in both chambers
D Sensing in both chambers
D Pulse inhibition and pulse triggering
R Rate adaptation
A/V Pacing in one chamber
A/V Sensing in one chamber
I Pulse inhibition in both chambers
R Rate adaptation
14 System Description
Diagnostic and Therapy Functions
General overview All the systems have extensive features that allow quick diagnosis and delivery of
safe therapy for bradycardia conditions.
Automatic functions make it easy and fast to implant, configure, and check the
pacemaker.
Auto-initialization after implantation: the device automatically detects the
implanted leads, sets the polarity and activates the automatic functions after
10 min.
Diagnostic functions Data from the last 10 interrogations and follow-ups are recorded as well as
arrhythmia episodes; they are stored together with other data to assess
patients and the state of the device at any time.
Automatic below-threshold impedance measurement is performed in the
device independent of the pacing pulse in order to check the lead for proper
functioning.
When performing follow-ups using the programmer, the IEGM is indicated with
markers after applying the programming head during the test procedure.
Antibradycardia pacing Sensing: the amplitudes of the P and R waves are measured in the device fully
automatically to record varying amplitudes. The sensitivity for the atrium and
ventricle is adapted automatically on an ongoing basis. The measurement data
are averaged and the trend can be displayed.
Thresholds: atrial as well as ventricular pacing thresholds are automatically
determined in the device. Capture control is used to set the pacing amplitudes
so that pacing is performed with the optimum atrial and ventricular amplitude
for the patients with each change of the pacing threshold.
Timing: pacing is particularly checked in the atrium by automatic adaptation
of the atrial refractory period to avoid pacemaker-induced tachycardia.
(Auto PVARP function: automatic post-ventricular atrial refractory period)
Additional, special form of rate adaptation: an increased cardiac output require-
ment is detected using physiological impedance measurement. The measuring
principle is based on contractile changes (ionotropy) of the myocardium
(CLS function: Closed Loop Stimulation). The suitable rate adaptation is
automatically initialized and optimized in CLS mode.
Ventricular pacing suppression: unnecessary ventricular pacing is avoided by
promoting intrinsic conduction (V
p
suppression function). The device can adapt
itself to conduction changes. In the case of intrinsic conduction, the device
switches to a DDD(R)-ADI(R) mode.
15 System Description
Home Monitoring The device automatically sends information to the transmitter once a day.
Additionally, the test messages can be initiated using the programmer.
Important medical information include, among others, the following:
Ongoing atrial and ventricular arrhythmia
Parameters relevant to leads in the atrium and ventricle: thresholds, sensing
amplitudes, impedances
Current statistics on bradycardia therapy
Individually adjustable device messages which enhance the device message
with additional information
IEGM online HD

with up to 3 channels in high definition with markers for


RA and RV, which each include the intrinsic rhythm and sequences with
encouraged sensing and pacing
Sending of these IEGM recordings with device messages
Test message triggered by the programmer to immediately check the
Home Monitoring function
Note: Under certain conditions, follow-ups supported by Home Monitoring can
replace in-office follow-ups, see Follow-up with BIOTRONIK Home Monitoring

,
p. 198.
16 System Description
Replacement Indications
Pacemaker operational
status indications
The time span from the beginning of service (BOS) to elective replacement indica-
tion (ERI) is determined by, among others, the following:
Battery capacity
Lead impedance
Pacing program
Pacing to inhibition ratio
Pacemaker circuit properties
The following are the defined pacemaker operational statuses:
ERI activation ERI detection is automatically activated after the following events:
Successful auto-initialization
Storage for longer than 24 months
ERI display ERI is displayed as follows:
On the programmer after interrogation of the pacemaker
By a defined decrease in the basic rate as well as the magnet rate
Change of the
pacing mode with ERI
From dual-chamber modes, the pacemaker switches to single-chamber pacing.
This replacement mode depends on the programmed mode and is displayed on
the programmer.
Deactivated functions
with ERI
The following functions are deactivated:
Atrial pacing
Night program
Rate adaptation
Atrial and ventricular capture control
Rate fading
Atrial overdrive pacing
IEGM recordings
Statistics
Home Monitoring
Rate hysteresis
Ventricular pacing suppression
BOS Beginning of Service Battery is in good condition;
normal follow-up.
ERI Elective Replacement
Indication
The replacement time has been
reached. The pacemaker must be
replaced.
EOS End of Service End of service time with regular
pacemaker activity.
17 System Description
Rate decrease The decrease of basic rate and magnet rate is defined as follows:
In the following pacing modes, the pacing rate decreases by 11%:
DDD(R); DDT(R); DOO(R); VDD(R); VDI(R); VVI(R); VVT(R); AAI(R); AAT(R); AOO(R)
In the pacing modes DDI(R) and DVI(R), only the VA interval is extended by 11%.
This reduces the pacing rate by 4.5 to 11%, depending on the configured
AV delay.
Magnet response at ERI After reaching ERI pacing is performed as follows after applying the magnet or
programming head:
Expected service time
after ERI
The information is based on a lead impedance of 500 Ohm at 100% pacing and
the data of the battery manufacturer.
For a lead impedance of 300 Ohm instead of 500 Ohm, these times decrease by
max. 30%.
Parameter with high pulse energy:
110 ppm; 4.6 V; 1.5 ms; 500 Ohm
Parameter with low pulse energy:
30 ppm; 0.2 V; 0.1 ms; 500 Ohm
Dual-chamber device in DDD(R) mode;
Single-chamber device in AAI(R)/VVI(R) mode
[in months]
Magnet mode
Cycles 1 to 10: After 10th cycle:
Automatically Asynchronous with
rate at 80 ppm
Synchronous with
basic rate reduced by
4.5 to 11%
Asynchronous Asynchronous with
rate at 80 ppm
Asynchronous with
rate at 80 ppm
Synchronous Synchronous with
basic rate reduced by
4.5 to 11%
Synchronous with
basic rate reduced by
4.5 to 11%
ERI to EOS
interval
Standard
program
With high pulse
energy
With low pulse
energy
Mean value 8 8 8
Minimum value 6 6 6
18
II Functional Description and Handling
Lumax FHB IIII365350-AEvia Function Manual
What's in this part? This part contains the following chapters:
Overview Please see part II of the function manual for a description of the device functions
and how to use them.
Chapter Chapter name Page
2 Auto-initialization 19
3 Lead Configuration and Monitoring 21
4 Sensing Functions 27
5 Bradycardia Therapy 34
6 Home Monitoring 174
7 Evaluating Holter Data 181
8 Statistics 183
9 System Functions of the Device 194
19
2 Auto-initialization
Auto-initialization2365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Auto-initialization of the device 20
20 Auto-initialization
Auto-initialization of the device
Purpose Auto-initialization allows for device startup without manual programming or
activation.
This can be used to significantly simplify the entire implantation procedure.
Functional principle Auto-initialization starts once a lead is connected to the device for the first time.
A 10-minute confirmation phase then begins, in which the polarity of the connected
lead is checked.
If stable impedance relations and lead polarities have been verified in this phase,
the device begins with normal device operation.
Lead detection The device already regularly delivers measuring pulses to the lead connections
during storage in the packaging.
If a lead impedance of less than 2500 Ohms is measured, the device begins the
auto-initialization process.
Confirmation phase A confirmation phase begins following initial lead detection.
This normally lasts 10 minutes. If 2 unipolar leads are connected, it can last up to
20 minutes.
During this confirmation phase, pacing and sensing function with the specified
standard values. The automatic functions are disabled.
The device checks whether conditions are stable for lead polarity and lead imped-
ance.
Automatic termination of
auto-initialization
After successfully ending the confirmation phase, the device begins the standard
program with automatic functions to adapt various parameters if no other perma-
nent program has been transferred.
If the programming head is applied while auto-initialization is running, a corre-
sponding status message is displayed in the status line of the user interface.
After successful completion of auto-initialization the follow-up page is available
with all interrogated device data and possibilities for tests and parameter configu-
ration.
Programming the device
prior to auto-initialization
If the device was already programmed during storage, auto-initialization is also
triggered by connecting a lead.
Then the programmed permanent program is active in the confirmation phase with
the pre-programmed lead polarity and the automatic function is disabled.
After a successful confirmation phase, the automatic functions are also available.
Manual termination of
auto-initialization
Auto-initialization is canceled if a permanent program is transmitted during
the confirmation phase. Then the device works immediately with the permanent
program.
Note: Once auto-initialization is canceled manually, it cannot be restarted or
repeated!
21
3 Lead Configuration and Monitoring
Lead Configuration and Monitoring3365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Automatic Lead Impedance Measurement and Check 22
Lead Configuration 24
Setting Lead Polarity 25
22 Lead Configuration and Monitoring
Automatic Lead Impedance Measurement and Check
Purpose The automatic lead check function can be used to quickly detect system (device and
lead) errors resulting from a defective lead or lead connection.
Automatic lead impedance measurement provides constantly up-to-date measured
impedance values via Home Monitoring or for interrogation with the programmer.
Moreover, automatic lead impedance measurement is required for auto-initializa-
tion.
Activation and deactivation The function is activated as part of the factory settings and is already working while
the device is still in the packaging.
It is not possible to activate or deactivate this function. There are no parameters
that can be edited.
The function is temporarily interrupted in the following situations:
Upon magnet application
During data collection for Home Monitoring (once per transmission for a few
minutes)
If a permanent program is transferred to the device, all present lead error
messages are deleted.
Functional description Automatic lead impedance measurement works constantly.
Provided corresponding leads are connected, the system measures lead imped-
ance in the atrium and the ventricle for the bipolar and the unipolar configuration.
Physical measuring
principle
The device delivers a low level (far below the pacing threshold) measuring pulse
especially for the impedance measurement. The impedance is calculated based on
the voltage drop measured in this process.
The energy of the pulse for measuring the lead impedance is very low:
Amplitude: 100 A
Pulse width: 30 s
Synchronization with
the cardiac cycle
The measuring pulse is delivered synchronously to the cardiac rhythm 90 ms after
a ventricular sensed event (detected intrinsic activity) or paced event in each case.
At most, one measuring pulse is delivered for each cardiac cycle.
Time sequence With dual-chamber devices, the lead impedances are measured in four consecutive
cardiac cycles in the following order:
Atrial, bipolar
Atrial, unipolar
Ventricular, bipolar
Ventricular, unipolar
With single-chamber devices, this sequence is shortened accordingly.
The measuring sequence repeats automatically every 30 seconds.
23 Lead Configuration and Monitoring
Automatic lead check The automatic lead check verifies whether the measured values are within a range
from 100 to 2500 Ohms, which is defined as acceptable.
If a measurement result is outside this impedance range, the measurement is
repeated in the next two cardiac cycles.
Error message for bipolar
lead configuration
If the measurement results are outside the acceptable range for three consecutive
measurements during bipolar lead check, then the system responds as follows:
The system generates a message, which is displayed in the event list on the
follow-up page and in the TrendView during the next device interrogation or
follow-up.
Devices with the Home Monitoring function activated can immediately transmit
this information automatically to the Home Monitoring Service Center.
The system automatically switches to the unipolar configuration.
The system performs an automatic pacing threshold test (provided this function
is activated).
The maximum sensitivity of automatic sensitivity control is adapted.
Error message for unipolar
lead configuration
If the measurement results are outside the acceptable range for three consecutive
measurements during unipolar lead check, then the system responds as follows:
To prevent false lead error messages from being triggered by electromagnetic
interference (EMI), the system begins a 90-minute verification period.
Then three successive measuring cycles are run again.
If all three measured values are within the accepted impedance range,
the device returns to normal mode.
If at least one of the three measured values is outside the accepted imped-
ance range, the lead error is considered verified.
The system generates a message which is displayed in the event list on the
follow-up page and in the TrendView during the next device interrogation or
follow-up.
Devices with the Home Monitoring function activated can immediately transmit
this information automatically to the Home Monitoring Service Center.
Displaying the
measurement results on
the programmer
After successful interrogation, the programmer software displays the most
recently measured values before applying the programming head.
Impedance measurement is temporarily interrupted while the programming head
is being applied.
On the follow-up page, the impedance values are displayed for the active lead
configuration.
You can press the [TrendView] button to display the lead impedance history.
On the impedance test page of the user interface, measured values are also
displayed for the inactive lead configuration.
24 Lead Configuration and Monitoring
Lead Configuration
In a unipolar configuration, the negative pole (the cathode) is situated in the
heart, while the positive pole (the anode) is formed by the housing of the device.
In a bipolar configuration, both poles of the leads are situated in the heart. The
devices allow for programming separate lead polarities for pacing and sensing.
Advantages and
disadvantages
Compared with bipolar pacing, unipolar pacing has the advantage of being
clearly identifiable on the surface ECG and has slightly lower energy consump-
tion.
With unipolar pacing, the device housing represents one pole; therefore,
high pulse amplitudes can cause muscle stimulation in this area.
Because of its lower susceptibility to interference signals, i.e., due to skeletal
myopotentials, bipolar sensing offers a much better 'signal-to-noise-ratio'
than unipolar sensing. Therefore it is possible to program higher sensitivities
(lower values).
!
!
CAUTION
If a unipolar lead is used in the atrium or ventricle, the corresponding lead
configuration has to be programmed to unipolar. Otherwise entrance and/or
exit block will result.
25 Lead Configuration and Monitoring
Setting Lead Polarity
Purpose/description The device allows for programming separate lead configurations for pacing and
sensing:
Pacing polarity
Sensing polarity
If bipolar leads are connected, both a bipolar and unipolar lead configuration can be
set.
The advantage of the bipolar lead configuration is that higher sensitivities
(lower values) can be programmed.
The advantage of the unipolar lead configuration is that the pacing pulse is
easier to identify in the ECG, and the energy required is slightly less.
Default setting The device automatically sets the lead polarity during auto-initialization. The
bipolar or unipolar configuration is performed based on the available leads.
If a specific polarity has been programmed prior to auto-initialization, then this
has priority.
Permissible lead
configuration
All combinations are allowed.
Selecting device
parameters
Select Parameters Bradycardia to choose the device parameters.
Setting lead polarity Proceed as follows:
!
!
CAUTION
Exit or entrance block!
The device has to be programmed to UNIP if unipolar leads have been implanted.
Otherwise the patient who is dependent on the device is at acute risk because an
exit or entrance block would occur.
Step Action
1 Select [Parameters].
2 Select the desired polarity for pacing and sensing separately for
the atrium and ventricle:
[Pacing polarity]
[Sensing polarity]
3 Select [UNIP] for the unipolar lead configuration. The selected
value is accepted as the parameter and displayed.
4 Select [BIPL] for the bipolar lead configuration. The release window
for bipolar lead configuration is displayed.
26 Lead Configuration and Monitoring
Unacceptable parameter
combinations upon setting
the lead configuration
Unacceptable parameter combinations upon setting the lead configuration are
indicated by the icon for a parameter conflict:
Icon Meaning
The icon for a parameter conflict
Use the information in the Help, which is displayed
upon pressing the key, to resolve the parameter
conflict.
27
4 Sensing Functions
Sensing Functions 4365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Sensing Concept 28
Automatic Sensitivity Control 29
Interference Interval as Interference Protection 32
Sensitivity - Manual Setting or Automatic Regulation 32
28 Sensing Functions
Sensing Concept
Background Sensing thresholds of device leads usually remain steady over a longer period of
time. Typical values are 3 - 4 mV for the atrium and about 12 mV for the ventricle.
Development of the
automatic sensitivity
control function
Early generations of pacemakers used the sensing of atrial events even during
atrial flutter or fibrillation for pacemaker timing and thus often induced ventricular
tachyarrhythmias. Mode switching algorithms prevented this undesirable behavior
by switching over to ventricular timing.
The development of implantable cardiac defibrillators provided functions for
automatic sensitivity control for the right ventricle and the right atrium, which can
correctly capture particularly small and varying signal amplitudes during flutter
or fibrillation. This function automatically adapts sensitivity to the occurring signal
amplitudes and provides for proper therapy by the device due to correct signal
processing.
Implementation in the
new device family
Recent studies have shown that approximately 50% of patients develop episodes of
atrial fibrillation even if they were previously without pathological findings.
Logically, the concept of automatic sensitivity control has been implemented in the
new device family. Diagnostics and mode switching have been optimized by proper
capturing of atrial flutter or fibrillation.
29 Sensing Functions
Automatic Sensitivity Control
The input filters of the device are aligned with signal sensing in the range between
the sinus rhythm, atrial fibrillation and ventricular fibrillation. Noise is suppressed
during signal sensing.
The sensitivity values in the atrium and right ventricle are dynamically adapted
independently of each other with each cardiac activity (beat-to-beat).
Signal recording and
filtering
The IEGM signal is recorded at the lead tip and converted into a digital signal. The
digitized signal passes through a bandpass filter, which allows signal frequencies
between 18 and 100 Hz to pass. T waves (s 18 Hz) and myopotentials (> 100 Hz) are
thus excluded as sources of interference for sensing.
Signal processing is carried out for fixed sensitivity values as well as for automatic
sensitivity control.
Filter characteristics
The automatic sensitivity
control principle
When using automatic sensitivity control, the function automatically measures the
amplitude peak and adapts the sensing threshold automatically as shown in the
illustration below. After every sensed event, the function starts the detection hold-
off period and measures the highest peak of the amplitude. After this initial stage,
the sensitivity is initially reduced to 50% of the measured peaks of the amplitude.
At the end of the step duration, sensitivity is reduced to 25% of the measured peaks
of the amplitude, but never below the minimum adjustable value for sensitivity.
This function automates setting of sensitivity and relieves the physician of having to
make the setting manually.
Amplitudes with highly variable peaks and small peaks are recorded reliably.
The signal-to-noise ratio of 1:4 suppresses undesired noise.
200 500 50 5
1
2
5
10
20
50
2 k 20 10 100
Frequency distribution of R-, P- and T-wave
and muscle noise (Myo)
R
Frequency / Hz
P
Myo
T
A
m
p
l
i
t
u
d
e

/

m
V
30 Sensing Functions
Automatic sensitivity
control in the ventricle
in the case of sensing,
functions the same way in
the atrium
Phases of automatic sensitivity control
The timing intervals for periodical adaptations of the sensitivity in the case of a
sensed event are specified in different ways for the atrium and the ventricle:
Atrium
Detection hold-off period: 100 ms
Step duration: 80 ms
The reduction limit is equal to the maximum sensitivity:
0.2 mV bipolar, 0.5 mV unipolar
Ventricle
Detection hold-off period: 120 ms
Step duration: 125 ms
The reduction limit is equal to the maximum sensitivity:
2 mV, unipolar or bipolar
Note: After a pause of > 1 s without sensing, the maximum sensitivity is adjusted.
31 Sensing Functions
Automatic sensitivity
control in the ventricle
in the case of pacing,
functions the same way in
the atrium
Phases of automatic sensitivity control
In the case of a paced event, the sensitivities are adjusted to fixed values for atrium
and ventricle at the start.
The timing intervals for periodical adaptations of the sensitivity in the case of a
paced event are specified in different ways for the atrium and the ventricle:
Atrium
Detection hold-off period: 100 ms
Step duration: 80 ms
Initial sensitivity value: 2 mV
Ventricle
Detection hold-off period: 120 ms
Step duration: 125 ms
Initial sensitivity value: 5 mV
of predefined value
Detection hold-off period
+/- Maximum
sensitivity
Step
duration
Paced
2 x Step duration
Fix predefined
value:
Atrium: 2 mV
Ventricle: 5 mV
Predefined
value
of predefined value
32 Sensing Functions
Interference Interval as Interference Protection
Function The interference interval prevents spontaneous or paced events in the ventricle
from being sensed falsely in the atrium and vice versa.
Therefore, atrial and ventricular events are followed by blanking periods to ensure
adequate sensing.
QRS far-field sensing can cause problems with mode switching and during rhythm
evaluation. Therefore, preventing QRS far-field sensing is of particular interest.
Likewise, a blanking period is initiated in the ventricle after an atrial pace to
prevent far-field sensing in the ventricle.
Sensed events within an interference interval are not evaluated as tachycardia
rates. A sensed event within a noise interval (50 ms) restarts the noise interval
(50 ms). The noise interval can be retriggered.
Constantly restarting the noise interval leads to asynchronous pacing.
Sensing of noise
The interference interval is 50 ms and starts after the following events:
Sensing
Detection hold-off period
No sensing takes place during the interference interval.
Sensitivity - Manual Setting or Automatic Regulation
Purpose The sensitivity of the device's sensing function is either dynamically updated by the
automatic sensitivity control or it is manually programmed to a set value.
An optimally configured sensing threshold guarantees certain sensing of intrinsic
events, but at the same time ignores electromagnetic interference and other inter-
ference signals.
Preset device behavior In the factory settings, the automatic sensitivity control is active immediately after
auto-initialization of the device.
If you wish to deactivate automated control and set fixed values instead, you have to
program this manually before, during, or after auto-initialization.
Noise detection
Detection hold-off period
+/- Dynamic
sensitivity threshold
(from the previous event)
33 Sensing Functions
Manual programming Proceed as follows to disable automated control and manually specify sensitivity:
User interface Value window for manual adjustment of the sensing threshold. The currently
measured amplitude of the P wave or R wave is displayed in the bottom line.

Brief description: automatic
sensitivity control
The automatic sensitivity control measures the pulse peak of the R or P wave and
adapts the sensing threshold for every cardiac cycle each time (beat-to-beat).
The sensing threshold is decreased to a quarter of the peak value in two incre-
ments based on the measured value of the pulse peak. This lasts 180 ms (for
the atrium) or 245 ms (for the ventricle) overall.
As differs from the manual setting, the maximum automatically adjustable sensi-
tivity (lowest sensing threshold) amounts to 2.0 mV (ventricle) and 0.2 mV (atrium,
bipolar sensing) or 0.5 mV (atrium, unipolar sensing).
If no new signal has been sensed within one second after sensing, the control
algorithm sets itself to the maximum sensitivity.
After a pacing pulse, regulation reaches maximum sensitivity after 360 ms (atrium)
or 575 ms (ventricle).
Thus intrinsic rhythms repeatedly have the chance to be sensed by the device and
trigger sensitivity adaptation.
Rate filters and algorithms for blanking interferences and events that have not
been classified as As or Vs guarantee a high level of reliability of automatic
sensitivity control functioning.
Step Action
1 Open Parameters Bradycardia.
2 Select a channel (A or V) for the Sensitivity [mV] parameter.
The software opens the corresponding value window.
3 Select a suitable value for the sensing threshold. The value window
displays the amplitude measured last (R or P wave) in the bottom line.
4 Close the values window.
5 Press the [Program] button to transmit the settings to the device.
34
5 Bradycardia Therapy
Bradycardia Therapy5365350-AEvia Function Manual
What's in this chapter? This chapter contains the following sections:
Section Topic Page
5.1 Pacing Modes 35
5.2 Pacing Parameters 46
5.3 Timing Functions 51
5.4 Atrial and Ventricular Capture Control 102
5.5 Rate Adaptation 129
5.6 Antitachycardia Functions 149
5.7 Patient Data and Diagnostics/HM Tabs 169
35 Bradycardia Therapy
5.1 Pacing Modes
What's in this section? This section contains the following topics:
Topic Page
Pacing Mode 36
Standard Pacing Modes 37
Summary of the Functions and Time Intervals of the Pacing Modes 42
Rate-Adaptive Modes 43
Pacing when Exposed to Interference 43
Setting the Magnet Response 44
36 Bradycardia Therapy
Pacing Mode
Purpose Timing, functionality, parameters and ranges of values are based on the pacing
modes.
This is why the set pacing modes are significant for bradycardia therapy.
Selectable pacing modes The following pacing modes are available:
Special features when
switching the pacing modes
The following parameters change when switching the pacing modes.
When switching to a DDD-CLS pacing mode:
AV hysteresis is set to Mean.
The dynamic AV delay is set to Low.
When switching from a DDD-CLS pacing mode to a motion based
(non-DDD-CLS) pacing mode, the following values remain unchanged:
AV hysteresis
Dynamic AV delay
Individual AV delays
are not changed
When switching from a DDD-CLS pacing mode to a motion based (non-DDD-CLS)
pacing mode, the values of the dynamic AV delay remain unchanged if one of the
following conditions is met:
Device type Pacing mode Standard
DR, DR-T DDD-CLS, VVI-CLS
DDDR, DDIR, DVIR, DOOR, VDDR, VDIR,
VVIR, VVTR, VOOR, AAIR, AATR, AOOR
DDDR-ADIR, DDD-ADI
DDD, DDT, DDI, DVI, DOO, VDD, VDI, VVI,
VVT, VOO, AAI, AAT, AOO, OFF
DDDR
SR, SR-T VVI-CLS
VVIR, VOOR, AAIR, AATR, AOOR, VVI, VVT,
VVTR, VOO, AAI, AAT, AOO, OFF
VVIR
Note: Home Monitoring is possible in all pacing modes in T variant devices.
If ... Then ...
the user has changed the dynamic
AV delay individually as part of
optimization,
these individual values remain unchanged.
They are not changed when switching the
pacing modes.
the user has selected the
standard values of dynamic
AV delay for DDD-CLS,
the standard values of the non-CLS pacing
mode will be displayed.
37 Bradycardia Therapy
Standard Pacing Modes
Overview The following pacing modes will be described:
DDD, DDI, DVI, VDD
AAI, VVI
AOO, VOO, DOO
Triggered modes
OFF (only possible temporarily during follow-up for diagnostic purposes)
DDD mode In the DDD mode, the basic interval starts with an atrial sensed (As) or atrial paced
event (Ap) or a ventricular sensed event without a preceding atrial event (PVC =
premature ventricular contraction). If no atrial sensed event occurs within the basic
interval, atrial pacing takes place at the end of the basic interval and the basic
interval is restarted.
AV sequential pacing in the DDD mode in the case of missing intrinsic cardiac
events
Atrial/ventricular events Atrial/ventricular sensed events have the following impact in DDD mode:
Basic interval
AV delay
If... Then ...
an atrial sensed or paced event
takes place,
the AV delay starts with the basic interval.
no ventricular sensing occurs
during the AV delay,
the pacemaker delivers a pacing pulse in
the ventricle at the end of the AV delay.
ventricular sensing (Vs) occurs
during the AV delay,
the delivery of a ventricular pulse (Vp) is
inhibited.
atrial sensing occurs, atrial pacing is inhibited and the basic
interval is restarted.
38 Bradycardia Therapy
An atrial sensed event restarts the basic interval
Table 1 summarizes the intervals initiated by sensing or pacing. The table distin-
guishes between pacing at the end of the AV delay (Vp) or pacing at the end of the
AV safety delay (Vsp) and between sensing within the AV delay (Vs) or sensing
outside the AV delay (PVC).
Start of timing intervals in DDD mode depending on the occurring events
Basic interval
Atrial refractory period
UTR interval
Ventr. refractory period
Dynamic AV delay
AV safety delay
Atr. interference interval
Ventr. interference interval
Atr. blanking
Ventr. blanking
A
P

V
S
V
S
(PVC)
A
S
V
P
PVARP
39 Bradycardia Therapy
VDD mode The VDD mode is derived from the DDD mode. The difference is that no atrial pacing
takes place.
Sensed events Sensed events have the following impact in VDD mode:
If the sensed event does not take place, then the basic interval starts with
an atrial sensed event, a premature ventricular contraction or with the end of
the preceding basic interval.
Prevention of pacemaker-mediated tachycardias in VDD mode
DDI mode In contrast to the DDD mode, the basic interval in DDI mode does not start with
a P wave, but rather with ventricular sensed or paced events. The VA interval is
started together with the basic interval.
AV sequential pacing in the DDI mode in the case of missing intrinsic cardiac
events
PVARP
Basic interval
Atrial refractory period
A
S
V
P
A
S
V
P
V
P
Basic interval
VA interval
VA delay
A
P
V
P
A
P
V
P
A
P
V
P
40 Bradycardia Therapy
Atrial/ventricular events Atrial/ventricular sensed events have the following impact in DDI mode:
Inhibition of atrial pacing in DDI mode by an atrial sensed event occurring within
the VA interval. At the end of the VA interval, the atrial refractory period restarts.
DVI mode The DVI mode is derived from the DDI mode. In contrast to the latter, atrial sensing
does not occur in DVI mode. Therefore, atrial pacing is forced at the end of the
VA delay.
Ventricular events Ventricular sensed events have the following impact in DVI mode:
If ventricular sensing occurs during the VA interval, then atrial and ventricular
pulse delivery are inhibited.
AAI and VVI modes The AAI and VVI single-chamber pacing modes are used for atrial or ventricular
demand pacing. In each case, pacing and sensing only occur in either the atrium
(AAI) or the ventricle (VVI). The basic interval is started by a sensed or paced event.
Sensed events Sensed events have the following impact in the AAI and VVI modes:
If a sensed event is recognized within the basic interval, then pulse delivery is
inhibited. Otherwise, pacing takes place at the end of the basic interval.
AOO and VOO modes In these pacing modes, pulses are emitted asynchronously in the atrium (AOO) or
ventricle (VOO).
If... Then ...
no atrial or ventricular sensing
occurs during the VA interval,
atrial pacing takes place at the end of the
VA interval. The AV delay is restarted together
with the pacing.
sensing occurs, atrial pulse delivery is inhibited, yet the AV
delay does not start with the sensed event,
but again at the end of the VA interval. There-
fore P waves do not trigger ventricular events
in the DDI mode.
PVARP
Basic interval
Atrial refractory period
VA interval
AV delay
A
P

V
S
V
S
(PVC) A
S
V
P
Note: When programming the VOO or AOO modes, you should consider the risks
associated with asynchronous ventricular pacing.
41 Bradycardia Therapy
DOO mode Asynchronous AV sequential pulses are emitted in this pacing mode (DOO).
Triggered pacing The triggered pacing modes correspond to the respective demand pacing modes
with the following distinction: no pulse inhibition takes place upon sensing of an
atrial/ventricular event outside of the refractory period. Instead, pulse delivery is
carried out immediately in the respective chamber.
The corresponding pacing modes are:
There is no AV safety delay in the DDT, DDI/T, and DVT pacing modes. This is not
necessary because ventricular pulse inhibition in cases of crosstalk (ventricular
sensing of the atrial pacing pulse) cannot occur in these modes.
Sensed events Sensed events have the following impact in the triggered pacing modes:
VDI mode The VDI mode is derived from the VVI mode. In contrast to the latter, the VDI mode
enables registration of intra-atrial events. However, the timing corresponds to that
of the VVI mode.
Retrograde conduction
measurement
The VDI mode is designed for measuring retrograde conduction with the IEGM
and/or the marker function.
If there is retrograde conduction,
then it can be measured as the time interval between a ventricular paced or
sensed event and the subsequent atrial sensed event. This can be measured
using the programming device or an additional ECG device.
OFF mode No pacing pulses are delivered in the OFF mode. External pulse control (NIPS)
represents one exception to this.
Purpose Without external pulse control, the OFF mode is used for detection and morpho-
logical evaluation of the intrinsic rhythm.
With external pulse control, the OFF mode is used for electrophysiologic
studies and to combat tachycardia.
The pulse and control parameters remain adjustable in the OFF mode because
the external pulse control function of the programmer can be used to trigger
pacing pulses and to transmit sensed events to the programmer. Note that
sensing is limited by the refractory period, whereas pacing is not.
Note: When programming the DOO mode, you should consider the risks
associated with asynchronous ventricular pacing.
Pacing mode
Demand DDD VDD DDI DVI AAI VVI
Triggered DDT VDT DDI/T DVT AAT VVT
If... Then ...
atrial/ventricular events are
sensed outside of the refractory
period,
no pulse inhibition occurs, but a pulse is
delivered immediately out in the respective
chamber.
ventricular sensed events occur
during the AV delay,
the basic interval is not restarted in pacing
modes DDI/T and DVT.
42 Bradycardia Therapy
Summary of the Functions and Time Intervals of the Pacing Modes
About this table The table summarizes the functions and time intervals that apply to the various
demand pacing modes. Not included are rate-adaptive parameters and parameters
that can be programmed in all pacing modes.
The sensitivity can always be programmed during pulse inhibition and/or pulse
triggering.
Table 1: Functions and timing intervals of the different pacing modes
Table legend:
x = present
A = atrium, atrial
V = ventricle, ventricular
A
p
= atrial paced event
A
s
= atrial sensed event
V
p
= ventricular paced event
V
s
= ventricular sensed event
Parameters Pacing modes
D
D
D
D
D
D
-
C
L
S
D
D
D
-
A
D
I
D
D
T
D
D
I
D
D
I
/
T
D
V
I
D
V
T
V
D
D
V
D
T
V
D
I
A
A
I
A
A
T
V
V
I
V
V
T
Basic rate x x x x x x x x x x x x x x x
Rate hysteresis x x x x x x x x x x x
Repetitive rate hysteresis x x x x x x x x x x x
Scan rate hysteresis x x x x x x x x x x x
Upper tracking rate (UTR) x x x x x x x x x x
A pulse width / amplitude x x x x x x x x x x
V pulse width / amplitude x x x x x x x x x x x x x
A
S
inhibits A
P
x x x x x
A
S
triggers A
P
x x x
A
s
triggers V
p
x x x x x x
V
S
inhibits V
P
x x x x x x x x x
V
S
triggers V
P
x x x x x
A refractory period x x x x x x x x x x x
V refractory period x x x x x x x x x x x x x
Dynamic AV delay x x x x
AV hysteresis x x x
AV repetitive hysteresis x x x
AV scan hysteresis x x x
AV safety delay x x x x x
Sense compensation x x x x
V blanking period x x x x x x x x
Wenckebach possible x x x x
43 Bradycardia Therapy
Rate-Adaptive Modes
Rate adaptation via CLS The device achieves physiological rate adaptation with closed loop stimulation.
The closed loop modes are functionally identical to the non rate-adaptive modes,
but differ in that the basic rate increases if the device senses patient stress or
exertion. The closed loop modes are indicated by CLS.
Rate adaptation via
motion sensor
Rate-adaptive modes are marked by an R (for rate) in the pacemaker code.
Functioning of the rate-adaptive modes is identical to that of the corresponding
non-rate-adaptive modes except that the basic rate increases when patient
exertion is sensed by the motion sensor.
Pacing when Exposed to Interference
Purpose The pacemaker is equipped with interference protection to protect the patient
against undesired inhibition by non-cardiac signals.
Description An interference interval is started at the same time as the refractory period.
The interference interval corresponds to a resettable refractory period of 50 ms.
If an event is sensed in one of the two chambers during the interference interval,
the interference interval in the corresponding channel is restarted. If the sensing
rate exceeds 1200 bpm, then the interference interval is continually restarted,
so that the channel remains refractory throughout the entire basic interval. The
pacemaker will then pace asynchronously at the programmed basic rate in that
particular chamber as long as the interference (e.g., electrical or electromagnetic
interference) persists.
Interference mode Depending on whether the interference is sensed in the atrium or the ventricle, the
pacing modes will change for the duration of the interference as shown below:
Note: In rate-adaptive modes (DDD-CLS, VVI-CLS, DDDR, DDIR, DVIR, VDDR,
VVIR, AAIR), it is possible that the atrial or ventricular refractory period can
comprise a major portion of the basic interval at high rates, so that sensing of
intrinsic actions is limited or completely suspended.
Note: Automatic switching to DDI or DDIR mode is performed when using mode
switching.
Mode Pacing mode during interference
Atrium Ventricle Atrium and ventricle
DDD-CLS DVI-CLS DAD-CLS D00(R)
DDI(R) DVI(R) DAI(R) D00(R)
DVI(R) D00(R)
VDD(R) VVI(R) VAT(R) V00(R)
VVI-CLS V00(R)
VVI(R) V00(R)
DDT(R) DVT(R) DAT(R) D00(R)
DDI/T(R) DVT(R) DAT(R) D00(R)
DVT(R) D00(R)
VDT(R) VVT(R) VAT(R) V00(R)
VDI(R) VVI(R) V00(R) V00(R)
VVT(R) V00(R)
44 Bradycardia Therapy
Setting the Magnet Response
Purpose Magnet responses are used to check the device's pacing functions. When the
magnet is applied, the built-in magnetic switch in the device closes. The device's
response to magnet application is adjustable. The following settings can be made:
Automatic magnet response
Asynchronous magnet response
Synchronous magnet response
Deactivated functions due
to magnet application
Upon transmission of changed parameters, the magnet effect is set to synchronous
for the duration of magnet application if it was previously set to asynchronous.
Automatic magnet
response
During the first 10 cycles after magnet application, the device paces asynchro-
nously at 90 ppm (or at 80ppm after reaching elective replacement indication).
Thereafter, pacing is synchronous with the set basic rate or the night rate, if one
was set.
During asynchronous pacing, the AV delay is reduced to 100 ms if a longer interval
has been set. This avoids ventricular fusion beats when AV conduction is intact and
makes it easier to sense the effectiveness or ineffectiveness of ventricular pacing.
Asynchronous magnet
response
The sensing function of the device is deactivated for the duration of the external
magnet application. During this time, the device paces asynchronously at 90 ppm
(or at 80ppm after reaching elective replacement indication).
Note: The following functions are deactivated by magnet application:
Recording of statistics
Vp suppression
Automatic impedance recording
Arrhythmia classification
Automatic lead check
Home Monitoring
Rate adaptation via accelerometer and CLS
PMT protection
Capture control
AV hystereses
Rate hystereses
IEGM recording
ERI detection
!
!
CAUTION
Unphysiological rhythm changes upon magnet application!
Upon applying the magnet with the asynchronous mode setting, unphysiological
rhythm changes can occur. Implement countermeasures if necessary!
45 Bradycardia Therapy
Synchronous magnet
response
The device's sensing and pacing behavior remains unchanged upon magnet appli-
cation. The basic rate also remains intact unless elective replacement indication is
reached. The synchronous magnet response is only significant for follow-up and
cases in which IEGM recordings are to be triggered by the patient. This guarantees
that the sensing function is preserved when magnets are applied.
Setting the
magnet response
Set the magnet response as follows:
Step Action
1 Select Parameters Bradycardia Basic rate/Night rate to open
the program window for magnet response.
2 Select [Magnet response] and set the parameter accordingly.
3 Select [Program] to transmit the changed magnet response
directly to the device.
46 Bradycardia Therapy
5.2 Pacing Parameters
What's in this section? This section contains the following topics:
Topic Page
Pulse Amplitude and Pulse Width 47
Setting Pulse Amplitude and Pulse Width 47
Basic Rate during the Day and at Night 49
Setting the Basic Rate for Day and Night 50
47 Bradycardia Therapy
Pulse Amplitude and Pulse Width
Pulse amplitude The atrial and ventricular pulse amplitude parameters determine the amplitude in
[V] of the delivered pacing pulses.
Pulse width The atrial and ventricular pulse width parameters determine the duration in [ms]
of the pacing pulses.
In dual-chamber systems, the pulse amplitude and pulse width parameters can be
programmed separately for the atrium and the ventricle.
Setting Pulse Amplitude and Pulse Width
Purpose The values for the pulse amplitude and pulse width parameters are aligned with
the measured pacing threshold. This guarantees effective safe pacing. The lower
these values can be set with the addition of a safety margin above the pacing
threshold value for the pulse amplitudes, the longer the service life of the device
will be.
Pulse amplitude The values set for atrial and ventricular pulse amplitudes determine the amplitude
of the pacing pulses in volts.
Pulse width The values set for atrial and ventricular pulse widths determine the duration of
the pacing pulses in milliseconds.
Constant values The pulse amplitude and pulse width values remain constant during the entire
service life of the device. This applies to pulse amplitude values up to 7.5 volts.
Thus the safety margin is maintained even if the battery voltage decreases at the
end of the device's service life.
Selecting parameters Select Parameters Bradycardia to choose the device parameters.
Setting pulse amplitude
and pulse width
The pulse amplitude and pulse width are to be set independently of one another for
all channels.
Step Action Reaction
1 Select the parameter value for
[Pulse amplitude] in the desired
chamber.
The value window opens.
2 Change the desired value. The value appears in a different
color until it is transmitted to the
device.
3 Repeat the procedure for the
[Pulse width] parameters in
the desired chamber.

48 Bradycardia Therapy
Displaying threshold values Manually measured and configured Pulse amplitude and Pulse width parameter
values for the atrial and ventricular threshold are displayed in the Bradycardia
window.
Automatically
measured values
If the thresholds for the atrium and ventricle are automatically measured by
activating the Capture control feature, then the values are only displayed
and cannot be manually changed in the Bradycardia window. The automatically
measured values are indicated by the double arrow symbol.
Step Action Reaction
1 Select the [Pulse amplitude]
parameter separately for
atrium and ventricle.
The value window is displayed and
shows the threshold values in
addition to the value range.
2 Select the [Pulse width]
parameter separately for
atrium and ventricle.
The value window is displayed and
shows the threshold values in
addition to the value range.
49 Bradycardia Therapy
Basic Rate during the Day and at Night
Basic rate during the day A sensed or paced event starts the basic interval. If a sensed event does not occur
during the basic interval, the device emits a pulse at the end of the basic interval.
A sensed event inside the basic interval and outside the set refractory period
inhibits pacing and restarts the basic interval.
In the atrial-controlled modes, the basic interval is started by an atrial event.
In the atrial-controlled dual-chamber modes, the basic interval is also started
by a premature ventricular contraction.
In the ventricular-controlled modes, the basic interval is started by a ventricular
event.
Night rate If the night rate is activated, then the device changes its pacing activities to the
value of the set night rate during the night. This makes it possible to adapt the
pacing rate to the patient's reduced metabolic needs during this time.
Furthermore, VVI and VOO pacing may prevent the possible worsening of
hemodynamics.
The night rate as well as the beginning and end of the night can be set.
At the beginning of the night period, the basic rate and the hysteresis rate are
gradually reduced to the night values.
If rate adaptation is enabled, the sensor threshold during the night is increased by
one increment (less sensitive). This prevents undesirable rate increases even in
patients who do not sleep soundly.
After the night has ended, the device resumes the basic rate.
Note: Please take into consideration that the patient may travel to other time
zones. If this is expected, the night duration should be programmed accordingly
shorter or even deactivated.
Note: The internal clock of the pacemaker is automatically adjusted to the clock
of the programmer at every interrogation. Ensure that the time displayed on the
programmer is correct.
50 Bradycardia Therapy
Setting the Basic Rate for Day and Night
Purpose The basic rate serves as the device's pacing rate, which can be adapted to meet the
patient's individual needs. The basic rate is the lower rate limit, at which the device
paces the heart if the intrinsic rhythm is irregular or no longer present. In addition
to the basic rate during the day, a night rate can be set to account for a patient's
lower metabolic needs at night. The beginning and end of the night rate can be set
separately.
Selecting device
parameters
Select Parameters Bradycardia to choose the device parameters.
Setting the basic rate
and the night rate
Proceed as follows:
Device parameter: Basic rate/Night rate
Step Action
1 Select Basic rate/Night rate [ppm].
A window with the following parameters opens:
Basic rate [ppm]
Night rate [ppm]
2 Select the desired rates for day and night.
The following parameters do not appear until after the night rate
has been selected:
Night begins
Night ends
3 Select the desired values and then confirm with [OK] to accept the
set values.
Note: The time for the beginning and end of the night rate can be configured as
follows:
00:00 - 23:50 h
10-minute interval
51 Bradycardia Therapy
5.3 Timing Functions
What's in this section? This section contains the following topics:
Section Topic Page
5.3.1 Programs and Parameters 52
5.3.2 Functions of Rate Hysteresis 66
5.3.3 Functions of the Dynamic AV Delay 71
5.3.4 Refractory and Blanking Times 96
52 Bradycardia Therapy
5.3.1 Programs and Parameters
What's in this section? This section contains the following topics:
Topic Page
Setting and Transmitting Parameters 53
ProgramConsult - Default Settings for Clinical Indications 54
Creating and Using Individual Therapy Programs 65
53 Bradycardia Therapy
Setting and Transmitting Parameters
Purpose Use the parameters to adjust the device to individual patient requirements.
Sequence Setting parameters
Transmitting parameters to the device
Prerequisites The device must be interrogated first.
If interrogation is successful, the device data is transmitted to the programmer and
displayed.
Setting parameters Proceed as follows:
Transmitting parameters Select [Program] to transmit the changed parameters to the implanted device.
Step Action Result
1 Select [Parameters]. The Parameters window with
the Bradycardia tab is opened
and displays Parameters
(permanent) as a status in
the title bar.
2 Select the parameter values that
are appropriate for the patient.
The values are displayed in the
Parameters window on the
Bradycardia tab. The title bar
shows the status Parameters
(edited).
Note: After transmission, the changed parameters are immediately effective as a
new permanent program of the device.
Note: See the user manual Implant Control System ICS 3000 - Handling Basics in
the Setting and Programming Programs section for further information on
adjusting program functions.
54 Bradycardia Therapy
ProgramConsult - Default Settings for Clinical Indications
Overview The ProgramConsult function provides ten programs with preset parameters for
the most common bradycardia indications.
By selecting a program suggestion for a specific indication, a set of default
parameters are loaded which have shown to be effective for these indications.
Before programming, the parameters can be adjusted to fit the patient's individual
needs.
ProgramConsult for single
and dual chamber variants
The following indication therapy suggestions are available for the different device
models:
User interface Device parameter: ProgramConsult
Selecting and setting
ProgramConsult
Proceed as follows:
Indication DR(-T) SR(-T)
SSS including brady-tachy syndrome Yes No
SSS with chronotropic competence Yes No
Permanent high-degree AV block Yes No
Paroxysmal high-degree AV block Yes No
Bradycardia with permanent atrial fibrilla-
tion
Yes Yes
Dual node disease + permanent AV block Yes No
Dual node disease + paroxysmal AV block Yes No
Vasovagal syncope Yes No
Symptomatic first-degree AV block Yes No
Infrequent paroxysmal pauses (<5%) No Yes
Step Action
1 Select Parameters Program sets ProgramConsult.
2 Select the appropriate indication setting.
3 Adjust the program parameters to the patient's needs.
4 Transmit the parameters to the device.
55 Bradycardia Therapy
Indications and preset
parameters
The following tables provide an overview of all available indications with the preset
parameters.
Indication:
SSS (sick sinus syndrome)
including brady-tachy
syndrome
Parameter Default setting
Mode DDD-CLS
CLS Vp required No
CLS resting rate control + 20
Vp suppression OFF
Hysteresis OFF
Hysteresis: Repetitive cycles OFF
Hysteresis: Scan cycles OFF
AV hysteresis IRSplus
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) ModeSw
HAR limit 200 bpm
High ventricular rate (HVR) ON
HVR limit 160 bpm
HVR counter [Events] 8
Patient trigger OFF
Pre-trigger recording [%] 75
IEGM signal Filtered
56 Bradycardia Therapy
Indication:
SSS (sick sinus syndrome)
with chronotropic
competence
Parameter Default setting
Mode DDD
Vp suppression ON
Hysteresis OFF
Hysteresis: Repetitive cycles OFF
Hysteresis: Scan cycles OFF
AV hysteresis OFF
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) ModeSw
HAR limit 200 bpm
High ventricular rate (HVR) ON
HVR limit 160 bpm
HVR counter [Events] 8
Patient trigger OFF
Pre-trigger recording [%] 75
IEGM signal Filtered
57 Bradycardia Therapy
Indication:
permanent high-degree
AV block
Parameter Default setting
Mode DDD
Vp suppression OFF
Hysteresis -10
Hysteresis: Repetitive cycles 5
Hysteresis: Scan cycles 5
AV hysteresis OFF
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) OFF
HAR limit -
High ventricular rate (HVR) OFF
HVR limit -
HVR counter [Events] -
Patient trigger OFF
Pre-trigger recording [%] -
IEGM signal -
58 Bradycardia Therapy
Indication:
paroxysmal high-degree
AV block
Parameter Default setting
Mode DDD
Vp suppression ON
Hysteresis -10
Hysteresis: Repetitive cycles 5
Hysteresis: Scan cycles 5
AV hysteresis OFF
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) OFF
HAR limit -
High ventricular rate (HVR) OFF
HVR limit -
HVR counter [Events] -
Patient trigger OFF
Pre-trigger recording [%] -
IEGM signal -
59 Bradycardia Therapy
Indication:
bradycardia
with permanent
atrial fibrillation
Parameter Default setting
Mode VVI-CLS
CLS Vp required No
CLS resting rate control + 20
Vp suppression OFF
Hysteresis OFF
Hysteresis: Repetitive cycles OFF
Hysteresis: Scan cycles OFF
AV hysteresis OFF
Mode switching OFF
2:1 Lock-in protection OFF
PMT protection OFF
Atrial capture control -
Threshold test start -
Safety margin -
Time of day -
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) -
HAR limit -
High ventricular rate (HVR) ON
HVR limit 160 bpm
HVR counter [Events] 8
Patient trigger OFF
Pre-trigger recording [%] 75
IEGM signal Filtered
60 Bradycardia Therapy
Indication:
dual node disease +
permanent AV block
Parameter Default setting
Mode DDD-CLS
CLS Vp required Yes
CLS resting rate control + 20
Vp suppression OFF
Hysteresis OFF
Hysteresis: Repetitive cycles OFF
Hysteresis: Scan cycles OFF
AV hysteresis OFF
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) ModeSw
HAR limit 200 bpm
High ventricular rate (HVR) ON
HVR limit 160 bpm
HVR counter [Events] 8
Patient trigger OFF
Pre-trigger recording [%] 75
IEGM signal Filtered
61 Bradycardia Therapy
Indication:
dual node disease +
paroxysmal AV block
Parameter Default setting
Mode DDD-CLS
CLS Vp required No
CLS resting rate control + 20
Vp suppression OFF
Hysteresis OFF
Hysteresis: Repetitive cycles OFF
Hysteresis: Scan cycles OFF
AV hysteresis IRSplus
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) ModeSw
HAR limit 200 bpm
High ventricular rate (HVR) ON
HVR limit 160 bpm
HVR counter [Events] 8
Patient trigger OFF
Pre-trigger recording [%] 75
IEGM signal Filtered
62 Bradycardia Therapy
Indication:
vasovagal syncope
Parameter Default setting
Mode DDD-CLS
CLS Vp required No
CLS resting rate control + 20
Vp suppression OFF
Hysteresis OFF
Hysteresis: Repetitive cycles OFF
Hysteresis: Scan cycles OFF
AV hysteresis IRSplus
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) OFF
HAR limit -
High ventricular rate (HVR) OFF
HVR limit -
HVR counter [Events] -
Patient trigger OFF
Pre-trigger recording [%] -
IEGM signal -
63 Bradycardia Therapy
Indication:
symptomatic first-degree
AV block
Parameter Default setting
Mode DDD
Vp suppression OFF
Hysteresis OFF
Hysteresis: Repetitive cycles OFF
Hysteresis: Scan cycles OFF
AV hysteresis OFF
Mode switching ON
2:1 Lock-in protection ON
PMT protection ON
Atrial capture control ON
Threshold test start 3 V
Safety margin 1 V
Time of day 2:00 a.m.
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) OFF
HAR limit -
High ventricular rate (HVR) OFF
HVR limit -
HVR counter [Events] -
Patient trigger OFF
Pre-trigger recording [%] -
IEGM signal -
64 Bradycardia Therapy
Indication:
infrequent paroxysmal
pauses (< 5%)
Parameter Default setting
Mode VVI
Hysteresis -10
Hysteresis: Repetitive cycles 5
Hysteresis: Scan cycles 5
AV hysteresis OFF
Mode switching -
2:1 Lock-in protection -
PMT protection -
Atrial capture control -
Threshold test start -
Safety margin -
Time of day -
Ventricular capture control ON
Threshold test start 3 V
Safety margin 0.5 V
Time of day 2:00 a.m.
Holter settings Default setting
High atrial rate (HAR) OFF
HAR limit -
High ventricular rate (HVR) OFF
HVR limit -
HVR counter [Events] -
Patient trigger OFF
Pre-trigger recording [%] -
IEGM signal -
65 Bradycardia Therapy
Creating and Using Individual Therapy Programs
Overview It is possible to create up to three individually configured therapy programs. To do
this, the therapy parameters can be set as needed and stored under a name of your
choice.
Purpose This function serves to provide frequently required parameter configurations at
the push of a button.
Creating a therapy program Perform the following steps:
Using a therapy program Perform the following steps:
Step Action
1 Select [Parameters].
2 Set the parameters for the planned therapy in the Bradycardia
tab.
3 Select [Program sets].
4 Select [Store] for Individual1, Individual2 or
Individual3 (free memory).
5 Name the program using the virtual keyboard and complete your
entry by pressing Enter.
6 The individually created therapy program is available for all
patients with applicable indications.
Step Action
1 Interrogate the device.
2 Select [Parameters].
3 Select [Program sets].
4 Select your individually stored program by pressing the stored
name. The preset parameters are loaded.
5 Select [Program] to transmit the program to the device.
6 The preset parameters are activated.
Note: Pay attention to the individual conflict rules of the preset parameters.
In cases of conflict, adjust individual parameters.
66 Bradycardia Therapy
5.3.2 Functions of Rate Hysteresis
What's in this section? This section contains the following topics:
Topic Page
Rate Hysteresis 67
Repetitive Rate Hysteresis 68
Scan Rate Hysteresis 69
Setting Rate Hystereses 70
67 Bradycardia Therapy
Rate Hysteresis
Definition The rate hysteresis is specified as the difference from the basic rate. In rate-
adaptive pacing, the hysteresis remains constant while the hysteresis rate follows
the variable (sensor-controlled) basic rate.
Description To preserve a spontaneous rhythm once it occurs, a rate hysteresis can be
programmed in the modes DDD(R), DDT(R), DDI(R), VDD(R), VDI(R), VVI(R), VVT(R),
AAI(R) and AAT(R).
In this case, after a sensed event, the pacemaker not only waits for the duration
of the basic interval for a new sensed event, but also for the duration of the longer
hysteresis interval before pacing.
This means that the pacemaker tolerates a spontaneous rhythm whose rate lies
below the basic rate. However, the intrinsic rate must be higher than the rate that
corresponds to the hysteresis interval.
If a sensed event does not occur within the hysteresis interval, a pacing pulse is
delivered at the end of the hysteresis interval. The next interval then corresponds
to that of the basic rate or the interval determined by the sensor.
Starting events In the pacing modes DDD(R), DDT(R), VDD(R), AAT(R) and AAI(R), the hysteresis
interval starts with an atrial sensed event.
In the pacing modes DDI(R), VVI(R), VVT(R), and VDI(R), it starts with a ventric-
ular sensed event.
In the pacing modes DDD(R), DDT(R) and VDD(R), it also starts with a premature
ventricular contraction.
Note: If the rate hysteresis is to be used in the DDI mode, the AV delay must
be programmed shorter than the intrinsic conduction time. Otherwise, the
pacemaker paces at the hysteresis rate instead of the basic rate even in the
absence of spontaneous activity.
68 Bradycardia Therapy
Repetitive Rate Hysteresis
Purpose The repetitive rate hysteresis helps to maintain the spontaneous rhythm and
avoid unnecessary pacing in situations that exceed the basic hysteresis, such as
post-extrasystolic pauses.
Description If such a pause occurs, the pacemaker continues to pace at the hysteresis rate
for a programmable number of cycles instead of immediately reverting to the
basic rate.
An existing spontaneous rhythm is thus once again able to inhibit the pacemaker.
This prevents any worsening of the hemodynamics, as might otherwise occur in
modes such as VVI pacing.
The pacemaker supports and stabilizes the spontaneous atrial rhythm in the DDD
or DDDR pacing modes. This prevents the undesirable suppression of the sponta-
neous rhythm through overdrive pacing, especially during periods of rest.
Repetitive rate hysteresis is only activated in the presence of a stable intrinsic
rhythm, that is, when inhibition due to intrinsic rhythm has continuously occurred
over a period of at least 180 cycles.
69 Bradycardia Therapy
Scan Rate Hysteresis
Definition The scan rate hysteresis promotes a spontaneous rhythm during longer phases of
pacing.
Description If the scan hysteresis is activated, the pacemaker will reduce the pacing rate
temporarily to the hysteresis rate after every 180 consecutive atrial paced events.
The number of scan intervals can be programmed.
If no intrinsic event is sensed during the scan intervals, pacing at the basic rate is
resumed (at the sensor rate in rate-adaptive mode). Scanning for an intrinsic
rhythm is repeated after an additional 180 cycles.
Reaction to
vasovagal syncopes and
carotid sinus syndrome
The scan rate hysteresis can be used in conjunction with the repetitive rate
hysteresis to treat patients with vasovagal syncopes and carotid sinus syndrome of
a primarily cardioinhibitory type.
The following programming is recommended for this purpose:
This program will inhibit the pacemaker until bradycardia episodes occur. If the
rate drops due to an attack, the pacemaker will pace at the hysteresis rate for
the set number of repetition cycles (the confirmation period).
The pacemaker will switch to the higher intervention rate to prevent possible
syncope only if a spontaneous rhythm does not occur during the confirmation
period, which should be set as short as possible.
The pacemaker will scan for a spontaneous rhythm every 180 cycles (scan rate
hysteresis) to avoid long pacing phases. If the attack has been terminated by
that time, the pacemaker will be inhibited; otherwise, it will repeat the scan
every 180 cycles.
Parameter Recommended programming
Basic rate Increased value (e.g. 90 ppm)
Rate hysteresis So that the hysteresis rate at rest is always
lower than the intrinsic rhythm (e.g. -50)
Scan rate hysteresis Enabled with the number of cycles set
according to the patients condition
Repetitive rate hysteresis Enabled with a low number of cycles
Note: These patients should only be treated with a DDD(R) system to exploit the
contribution of the atrium to ventricular filling and to overall hemodynamics as
much as possible during such attacks.
70 Bradycardia Therapy
Setting Rate Hystereses
Purpose The device has a hysteresis function intended to maintain and support the patient's
intrinsic heart rhythm for as long as possible. In addition to the conventional
hysteresis function, additional hysteresis functions (scan and repetitive cycles)
can be activated.
Selecting device
parameters
Select Parameters Bradycardia to choose the device parameters.
Setting rate hystereses Proceed as follows:
Device parameter: Hysteresis
Step Action
1 Select Basic rate/Night rate.
The window contains the following parameters among others:
Hysteresis
Repetitive cycles
Scan cycles
2 Select Hysteresis and set the required hysteresis rate.
It is only possible to program the additional hystereses after
activating the hysteresis function.
3 Select the desired additional hysteresis function and determine
the number of scan or repetitive cycles. Confirm the settings with
[OK] to accept the values.
71 Bradycardia Therapy
5.3.3 Functions of the Dynamic AV Delay
What's in this section? This section contains the following topics:
Topic Page
Dynamic AV Delay 72
Setting the Dynamic AV Delay 74
EasyAV - Tool for Optimizing the AV Delay 77
AV Safety Delay 78
Sense Compensation 79
AV Hysteresis 80
AV Repetitive Hysteresis 80
AV Scan Hysteresis 81
Negative AV Hysteresis 82
Setting AV Hystereses 83
The Concept of Ventricular Pacing Suppression 86
How Ventricular Pacing Suppression Works 87
Setting Ventricular Pacing Suppression 94
IRSplus - Promoting Intrinsic AV Conduction 95
72 Bradycardia Therapy
Dynamic AV Delay
Description The AV delay defines the period of time between an atrial event and the subsequent
ventricular stimulus. The dynamic AV delay allows independent selection of AV
delays in five atrial rate ranges. The AV delay selected for this rate is then effective
depending on the current atrial rate (the AA interval). The dynamic AV delay is
started after atrial sensing and after sensor-driven atrial pacing. In the following
rate ranges, the AV delay can be selected as required. Basic rate:
40 60 ppm
61 80 ppm
81 100 ppm
101 120 ppm
121 140 ppm
141 160 ppm
In the non-rate-adaptive pacing modes, an AV delay may be separately selected for
AV sequential pacing at the basic rate. The AV delays in the four other atrial rate
ranges are only active after atrial sensing.
In addition to the option of setting the AV delay individually for these ranges,
the programmer also offers four pre-set options (low, medium, high and fixed).
Refer to the table below for details.
The optimization feature can be deactivated and fixed AV delays can be selected.
In non-rate-adaptive modes, the AV delay after atrial paced events is different
from the AV delay after atrial sensed events.
73 Bradycardia Therapy
Preset dynamic AV delays Preset dynamic AV delays in the DDDR mode (standard program)
Preset dynamic AV delays in the DDD-CLS mode (standard program)
Interpolation is performed between the values of 60 - 80 ppm.
The values for the dynamic AV delay in the DDD-CLS mode are especially
configured to prevent competitive stimulation.
Rate range AV delay (in ms) for programming
the dynamic AV delay to
Low Medium High
at 60 ppm 180 180 180
at 80 ppm 170 160 150
at 100 ppm 160 140 120
at 120 ppm 150 120 100
at 140 ppm 140 100 75
at 160 ppm 140 100 75
Fixed for all rate ranges 180
Frequency range AV delay (in ms) for programming
the dynamic AV delay to
Low Medium High
at 60 ppm 150 150 150
at 80 ppm 140 130 120
at 100 ppm 130 120 100
at 120 ppm 120 100 75
at 140 ppm 120 75 50
at 160 ppm 120 75 50
Fixed for all rate ranges 150
Note: The dynamic AV delay serves to prevent pacemaker-mediated tachycardias
and supraventricular tachycardias (Antitachycardia Functions, p. 149).
74 Bradycardia Therapy
Setting the Dynamic AV Delay
Purpose Dynamic AV delay simulates natural AV conduction in various stress situations.
Description The AV delay is the interval between an atrial event and the subsequent ventricular
stimulus. If the dynamic AV delay is programmed, then the AV delay automatically
changes according to the default values as the pacing rate increases.
In addition to this, the AV hysteresis changes the AV delay: A positive AV hysteresis
extends the AV delay and a negative AV hysteresis shortens the AV delay (see:
Setting AV Hystereses, p. 83).
Parameter overview The following settings can be selected for the AV delay:
Default AV delays for all rate ranges
Staged (see: Select default staged values, p. 75)
Fixed (see: Selecting a default fixed value, p. 76)
Individual AV delays for all rate ranges (see: Selecting individual values, p. 75)
Further settings are possible for:
AV delay after sense in combination with sense compensation
AV hystereses (see: Setting AV Hystereses, p. 83)
Sequence The dynamic AV delay is set for 6 rate ranges:
Either numerically via value windows
Or graphically using a curve that can be individually adjusted for each rate
range
75 Bradycardia Therapy
Accessing the
program window
Proceed as follows:
User interface Device parameter: Dynamic AV delay
Select default staged values Proceed as follows:
Selecting individual values Proceed as follows:
Step Action Result
1 Select Dynamic AV delay on
the Bradycardia tab in the
Parameters window.
The Dynamic AV delay
window is opened.
Step Action Result
1 Select [Low], [Medium] or
[High].
You can use the arrow keys to
change the default configura-
tion as a whole.
The default values are
displayed numerically and
graphically.
If the default settings
have been changed, then
the display changes to
[Individual] (see: Selecting
individual values, p. 75).
2 Accept values:
Select [OK].
Reject values:
Select [Cancel].
The [OK] button is used to accept
the values in the program and
display them in the Parameters
window.
Step Action Result
1 Select the suitable values
Numerically via the value
windows.
Graphically using the arrow
keys or via the circles on the
line segments.
If the default setting has been
changed, then the display
changes to [Individual].
The selected values are
displayed numerically and
graphically.
2 Accept values:
Select [OK].
Reject values:
Select [Cancel].
The [OK] button is used to accept
the values in the program and
display them in the Parameters
window.
76 Bradycardia Therapy
Selecting a default
fixed value
Proceed as follows:
AV delay after sense and
sense compensation
For hemodynamic reasons, it is desirable to maintain a constant delay between
an atrial and a ventricular contraction and to adjust it to physiologic conditions.
For this purpose, sense compensation can be used to shorten the AV delay after
atrial sensing.
Sense compensation can be programmed to specific values. In this case, the
AV delay after sense following atrial sensing is shorter than the delay after atrial
pacing by the programmed value. The AV delay after atrial pacing then corresponds
to the programmed AV delay.
Step Action Result
1 Select [Fixed]. The default value is displayed
numerically and graphically.
2 Select the suitable value:
Numerically via the value
windows.
Graphically with the
arrow keys.
The selected value is displayed
numerically and graphically.
3 Accept value:
Select [OK].
Reject value:
Select [Cancel].
The [OK] button is used to accept
the value in the program and
display it in the Parameter
window.
77 Bradycardia Therapy
EasyAV - Tool for Optimizing the AV Delay
Purpose The AV delay setting can be optimized using the AV delays that have actually
occurred and have been recorded for the rate ranges 60 - 140 ppm and thus be
adapted to more closely correspond with the physiological AV delay.
Description The EasyAV function uses the event statistics stored in the device to generate
five vertical lines at the rate marks 60, 80, 100, 120, and 140, which represent
the distribution of the AV delays recorded so far. The upper and lower horizontal
lines designate the recording range, whereas the middle horizontal line indicates
the median. The median indicates the AV delays that occurred most frequently.
These recordings can be used to adapt the AV delay.
The AV delay is recorded with the distribution of the A
s
-V
s
and A
p
-V
s
intervals.
Software interface EasyAV
Using EasyAV Proceed as follows:
Step Action Result
1 Select [Dynamic AV delay [ms]]. The Dynamic AV delay
window is opened.
2 Select [As-Vs interval distribu-
tion] or [Ap-Vs interval distribu-
tion].
Recordings of the AV delay are
indicated by vertical lines
3 You can optimize modification of
the AV delay directly in the
graphic by moving the points of
AV delay line at the 60 - 140 ppm
rate marks with the cursor
towards the median of the
vertical line.
The [OK] button is used to
accept the values in the
program and display them
in the Parameters window.
78 Bradycardia Therapy
AV Safety Delay
Protection against
pulse inhibition
If an atrial pace triggers ventricular oversensing through crosstalk, undesired
pulse inhibition in the ventricle can result. Sensing of the atrial pulse delivery in the
ventricular channel during the AV delay can be incorrectly interpreted as intrinsic
ventricle excitation.
Description In the DDD(R), DDI(R), and DVI(R) pacing modes, the AV safety delay is started
with atrial pacing. If a ventricular sensing occurs within the AV safety delay, the
pacemaker paces in the ventricle at the end of the interval (Vsp = ventricular safety
pace). If the AV delay is shorter than the AV safety delay, pacing occurs at the end of
the AV delay.
This prevents ventricular pulse inhibition through ventricular sensing of atrial
pacing (crosstalk).
If AV sequential pacing is observed with an AV delay corresponding to the AV safety
delay, this may be evidence of ventricular crosstalk (recognition of atrial pulse
delivery).
In order to avoid crosstalk, the following can be defined: a lower atrial pulse energy,
a lower ventricular sensitivity (higher numerical value) and/or a longer ventricular
blanking period.
The AV safety delay is not programmable and lasts 100 ms.
79 Bradycardia Therapy
Sense Compensation
Purpose For hemodynamic reasons, it is desirable to maintain a constant period between
an atrial and a ventricular contraction and to adjust it to physiologic conditions.
For this purpose, sense compensation can be used to shorten the AV delay after
atrial sensing.
Description You can program values of -10 to -120 ms for the sense compensation. In this case,
the AV delay after atrial sensing is shorter than the delay after atrial pacing by
the programmed value. The AV delay after atrial pacing then corresponds to the
programmed AV delay.
Sense Compensation
AV delay after sense 140 ms
AV delay correction 40 ms
AV delay after pace 180 ms
AS
140 ms
180 ms
40 ms
AP
80 Bradycardia Therapy
AV Hysteresis
Purpose AV hysteresis can be programmed to a low, medium, or high setting to promote
intrinsic AV conduction.
Description In the case of activated AV hysteresis, the AV delay is extended by a defined time
period after sensing an intrinsic ventricular event. The long AV delay remains intact
as long as an intrinsic ventricular activity is measured. The short AV delay interval
without extension by the hysteresis value then follows after repeated ventricular
pacing.
AV Repetitive Hysteresis
Purpose The AV repetitive hysteresis reduces pacing when existing intrinsic activity within
the extended AV delay is suppressed by occasional paced events.
Description With active AV repetitive hysteresis, the AV delay is extended by the defined
hysteresis value after the sensing of an intrinsic ventricular event.
In contrast to normal AV hysteresis, once the ventricular paced event occurs,
the long AV delay for a programmed number of cycles remains intact. If an intrinsic
activity occurs during one of these repetitive cycles, the long AV delay remains
intact. Only when the repetitive cycles have elapsed without spontaneous
AV conduction does the pacemaker switch back to the short AV delay.
As As As As As As
Vp Vp Vp Vs Vs Vs
AV interval AV hysteresis
!
!
CAUTION
If AV hysteresis is enabled along with the algorithm for detecting and terminating
pacemaker-mediated tachycardias (PMT management), the variations in the
AV delay for detection and termination of a PMT have priority over any possible
simultaneous activation of the AV hysteresis.
Example 1:
Intrinsic AV conduction
is achieved
Example 2:
Intrinsic AV conduction
is not achieved
As As As As As As As As As
Up to 10 repetitive extensions
of the AV interval
Repetition cycles elapsed
AV interval AV hysteresis
Vs Vp Vp Vp Vs Vs Vp Vp Vp
81 Bradycardia Therapy
AV Scan Hysteresis
Purpose The AV scan hysteresis reduces pacing in situations in which intrinsic conduction
exists but does not take place within the defined AV delay.
Description In AV scan hysteresis, the AV delay is switched to the interval extended by the
AV hysteresis after 180 consecutive cycles in which a paced event has occurred
without any spontaneous ventricular activity. The long AV delay remains intact
for a defined number of cycles.
If an intrinsic AV conduction occurs within the defined number of cycles, the
AV hysteresis remains intact.
The short AV delay resumes only when no ventricular event has been sensed
within the defined number of cycles and instead every one of these cycles ends
with a pacing. The cycle counter begins counting the consecutive paced cycles
again.
Intrinsic ventricular events (excluding PVC) reset the counter to zero and activate
AV hysteresis.
Vs Vp Vp Vp Vp Vs Vs Vp Vp Vp
As As As As As As As As As As
Example 2:
Intrinsic AV conduction
is not achieved
Example 1:
Intrinsic AV conduction
is achieved
Up to 10 extended AV scan intervals Scan cycles elapsed
AV interval AV hysteresis
179 180
82 Bradycardia Therapy
Negative AV Hysteresis
Purpose In individual cases, it may be necessary to support ventricular pacing and allow
the least possible conduction of the atrial intrinsic rhythm. This may be necessary
particularly for patients with hypertrophic obstructive cardiomyopathy (HOCM).
Description With a ventricular sensed event (Vs), the function decreases the AV delay and
thereby promotes ventricular pacing. As opposed to this, in conventional positive
AV hysteresis, the AV delay is extended to support intrinsic rhythms.
Negative AV hysteresis is optional. It is possible to program the negative
AV hysteresis function in combination with the negative AV repetitive hysteresis.
This ensures that pacing is carried out upon occurrence of a sensed event for a
programmable number of cycles with shorter AV delay.
Negative AV hysteresis The following table shows the correlation between the standard values for AV delay
and negative AV hysteresis:
AV delays (standard) Negative AV hysteresis
100 100
120 100
130 100
140 100
150 100
160 120
170 120
180 130
190 140
200 150
225 170
250 180
300 200
350 240
83 Bradycardia Therapy
Setting AV Hystereses
Purpose of positive
hysteresis
The positive AV hysteresis function serves to sustain the patients spontaneous
AV conduction as long as possible, thereby guaranteeing a natural contraction
sequence. This prevents any unnecessary pacing in the ventricle.
Purpose of negative
hysteresis
The negative AV hysteresis function supports ventricular pacing and allows the
least possible amount of conductions of the atrial intrinsic rhythm.
This may be necessary particularly for patients with hypertrophic obstructive
cardiomyopathy (HOCM) or for patients with congestive heart failure who receive
resynchronization therapy
Description For positive AV hysteresis, the programmed AV delay is extended by a defined
value and can be performed with various preference settings.
With a ventricular sensed event (Vs), a negative AV hysteresis decreases the
AV delay and thereby promotes ventricular pacing.
Note: IRSplus and AV hystereses cannot be activated if Vp suppression has
been activated.
84 Bradycardia Therapy
Setting the AV hysteresis Proceed as follows to set the AV hysteresis. The AV hysteresis value that is set will
prolong the AV delay by the same value.
Parameters: AV hysteresis
Displaying the AV delay and
hysteresis
In the AV delay chart, the selected settings are displayed as a dotted line. For a
positive AV hysteresis, the dotted line is above the solid line indicating the AV delay;
for a negative AV hysteresis, it is below the solid line. AV hystereses are shown so
that they correspond with the previously selected AV delays.
Step Action
1 The following functions and parameters for supporting intrinsic
conduction can be selected:
AV hysteresis
AV delay
AV delay after sense and Sense compensation
2 Use AV hysteresis to choose the hysteresis mode. The following
parameters can be set:
OFF
Negative
Low
Medium
High
IRSplus (see: IRSplus - Promoting Intrinsic AV Conduction,
p. 95)
3 Activate AV hysteresis and select the value range for the AV delay
(prolongation or shortening) in the respective window.
85 Bradycardia Therapy
Making additional
hysteresis settings
AV scan and AV repetitive hysteresis can only be activated if AV hysteresis is
enabled. Upon selecting the parameters, the number of cycles must be determined
in which the device attempts to determine and thus maintain AV conduction in the
patient.
AV repetitive hysteresis When AV repetitive hysteresis is activated, the AV delay is increased/decreased by
the defined hysteresis value after sensing an intrinsic ventricular event.
In contrast to normal AV hysteresis, once the ventricular paced event occurs,
the modified AV delay for a programmed number of cycles remains intact.
Positive If an intrinsic activity occurs during one of these repetitive cycles, the long
AV delay remains intact. Only when the repetitive cycles have elapsed without
spontaneous AV conduction does the pacemaker switch back to the short
AV delay.
The AV repetitive hysteresis hence reduces pacing when existing intrinsic
activity within the extended AV delay is suppressed by occasional paced events.
Negative The repetitive cycles occur with the decreased AV delay. When the cycles
are completed, the programmed AV delay is restored (increased). An intrinsic
ventricular event shortens the AV delay again.
Step Action
1 Set the number of AV repetitive cycles and AV scan
cycles.
2 Close the window with [OK] to accept the set values.
86 Bradycardia Therapy
The Concept of Ventricular Pacing Suppression
Why should
right ventricular pacing
be avoided?
Right ventricular pacing evokes an asymmetrical contraction of the ventricle due to
the unphysiological activation of the cardiac conduction system.
Various randomized studies performed with pacemaker and ICD patients have
shown that frequent ventricular pacing is connected with an increased risk of
congestive heart failure and atrial fibrillation as long-term effects.
Therefore, pacing should only be performed if it is clinically necessary.
Based on this new knowledge, it is widely accepted that pacemaker therapy should
avoid unnecessary right ventricular pacing.
This particularly applies to patients with sick sinus syndrome (SSS) and/or inter-
mittent AV block.
Which pacemaker types
are suitable for
which basic illness?
AAI pacemakers are sufficient for patients with intact AV conduction.
However, dual-chamber pacemakers are still indicated in most cases for safety
reasons if the patient develops an AV block, bradycardia-induced atrial fibrillation
or drug-induced bradycardia.
According to the German heart registry, this happens in 83% of the cases. The
device should be able to be programmed in such a way that unnecessary right
ventricular pacing can be avoided.
Dual-chamber pacemakers are always indicated for patients with AV block.
For patients with intermittent AV block, right ventricular pacing should cease in
phases of intrinsic AV conduction.
In cases of intermittent or permanent first-degree AV block, a decision has to
be made between delayed atrioventricular conduction and pacing with a short
AV delay, which is hemodynamically more effective.
Vp suppression:
option for avoiding right
ventricular pacing
In phases of intact AV conduction, pacing is performed in a mode similar to AAI.
In phases when there is no AV conduction, the mode is switched back to
DDD pacing and the right ventricle is paced.
The Vp suppression function enables the device to toggle between these two modes
according to the patient's needs.
87 Bradycardia Therapy
How Ventricular Pacing Suppression Works
Overview The following topics are described within this segment:
Activation of Vp suppression
Mode of functioning
Switching from DDD(R) to ADI(R)
Switching criterion and Vs continuity search
The Vs continuity search triggered by a single Vs
Vs continuity search triggered by a timing interval
Intelligent search
ADI(R) mode
Switching from ADI(R) to DDD(R)
Switching criterion: 2 seconds without Vs
Switching criterion: 2 consecutive cycles without Vs
Switching criterion: Programmable number X of 8 cycles without Vs
Summary
Vp suppression and mode switching
Statistics recordings of Vp suppression
Vp suppression and high rates
Vp suppression interactions with other functions and actions
Activation of
Vp suppression
The Vp suppression function is activated if the mode DDD-ADI or DDDR-ADIR is
selected.
Mode of functioning Vp suppression supports intrinsic AV conduction by only pacing in the ventricle if
intrinsic AV conduction becomes unstable or stops.
If there is intrinsic AV conduction, the function works in a mode similar to ADI(R).
If intrinsic AV conduction stops or becomes unstable, the function paces in
DDD (R) mode with the programmed AV delay in the ventricle.
Automatic mode switching between these two modes provides for maximum
intrinsic optimization without doing damage to the patient.
Scan algorithms with a programmed schedule test intrinsic AV conduction and
the AV delay is extended to 450 ms.
The ADI(R) mode - according to the NBG pacemaker code - describes precisely
what the device does in this state. Thus, as opposed to the AAI(R) mode, sensing is
also possible in the ventricle in order to switch to the DDD(R) mode and pace in the
ventricle in the case of ventricle pauses or unstable rhythms.
DDD(R) - ADI(R) mode DDD(R) - ADI(R) mode
Activation of
Vp suppression
Vs search algorithm
Functionality of Vp Suppression
A
V
condu
c
t
io
n
AV blo
c
k
DDD(R) functionality
AV delay: as programmed
ADI(R) functionality
AV delay: 450 ms
up to two cycles w/o Vs
88 Bradycardia Therapy
Switching from
DDD(R) to ADI(R)
If Vp suppression is activated by switching on the DDD(R)-ADI(R) mode, the function
initially works in DDD(R) mode, so that a ventricular stimulus is triggered at the
end of the AV delay.
During the DDD(R) activity, the device systematically scans to determine whether
there is an intrinsic ventricular signal.
If no activity is sensed for 30 s within the AV delay, the function starts a continuous
scan algorithm called the Vs continuity search.
The search for intrinsic ventricular activity can be triggered by two different events:
Sensing of a single Vs event within the AV delay (even PVC)
No ventricular sensed events within a certain time (intelligent search,
at least 30 s)
Switching criterion and
Vs continuity search
In order to prevent constant switching between DDD(R) and ADI(R), an additional
test is performed to verify stability of the intrinsic ventricular activity.
The device only switches to ADI(R) if a stable Vs activity is verified.
The Vs continuity search
triggered by a single Vs
If the device paces in the DDD(R)-ADI(R) mode according to the set AV delay and
senses a single Vs within the AV delay, then the Vs continuity test is started.
The search is successful if the set number of cycles has been sensed consecutively
within 8 cycles. If no Vs was sensed except for the initial Vs, then the device paces
for 8 cycles with an AV delay of 450 ms.
As a result, the device will work in the DDD(R) mode with the programmed AV delay
until the next Vs continuity test.
If the search was successful and the number of programmed consecutive Vs was
sensed, it switches to the ADI(R) mode.
DDD(R) - ADI(R)
mode
DDD(R)
functionality
DDD(R) to ADI(R) Switching criteria
and Vs Continuity test
AV Delay: as
programmed
DDD(R) - ADI(R)
mode
ADI(R)
functionality
AV Delay:
450 ms
up to two
cycles w/o Vs
AV Delay:
450 ms
for 8 cycles
6* out of 8
consecutive Vs
[*programmable
range: 2..(1)..8]
Vs
Continuity
1 single Vs
or
intelligent
search
after 30 sec
duration of Vp
no Vs Continuity Vs Continuity
As/Ap As/Ap As/Ap As/Ap
8x
DDD(R) Vs Continuity ADI(R)
Vp
Vs Vs Vs
450 ms AV delay
Programmed AV delay
6 consecutive Vs within 8 cycles
[programmable value: 1...(1)...8]
89 Bradycardia Therapy
Vs continuity search
triggered by a
timing interval
If the DDD(R)-ADI(R) mode has been set and the device paces with the programmed
AV delay in the ventricle, then the initial Vs continuity search begins 30 s after
removing the programming head.
The Vs continuity search runs in the same way within the programmed AV delay as
the search triggered by a single Vs.
The condition for switching to the ADI(R) mode is met if the programmed number of
Vs is consecutively sensed within 8 cycles.
Intelligent search The intelligent search serves to avoid frequent scan cycles for patients who have
no intrinsic activity.
The reason for this is that some patients become symptomatic if the device paces
with a long AV delay.
Every time the Vs continuity search is unsuccessful, the timing interval for starting
the search is doubled until a limit of 128 min. is reached. Then the Vp suppression
function will only search every 20 hours for intrinsic AV conduction. The scan
interval is set to 20 hours instead of every 24 hours so that the search is initialized
at different times of day. The search is carried out at different times of day and night
in a 6-day cycle.
The Vp suppression function does not deactivate itself entirely on its own.
Intelligent search time schedule
ADI(R) mode The device always works in ADI(R) mode if there is stable intrinsic activity.
If the device works in ADI(R) mode according to NBG nomenclature, then pacing is
only performed in the atrium (A). Sensing takes place in both chambers (D), but
atrial pacing is inhibited (I) if the intrinsic rate is higher than the basic rate or the
rate specified by the sensor (R).
While working in ADI(R) mode, no ventricular pacing is carried out. If no ventricular
sensing occurs within two cardiac cycles or within 2 seconds, then it switches to
DDD(R) mode.
While the device is working in the ADI(R) mode, sensing is performed in the atrium
and ventricle. The AV delay is 450 ms and is not followed by a ventricular stimulus.
As/Ap As/Ap As/Ap As/Ap
8x
DDD(R) Vs Continuity ADI(R)
Vp
450 ms AV delay
...30 sec
pacing with
programmed
AV delay
6 consecutive Vs within 8 cycles
[programmable value: 1...(1)...8]
Vs Vs Vs
30 sec > 1 min > 2 min > 4 min > .... > 128 min > 20 h
90 Bradycardia Therapy
Switching from
ADI(R) to DDD(R)
If no more intrinsic ventricular activity is sensed, it switches to DDD(R) mode.
In order to safely account for all situations, there are four different criteria which
result in switching and they all work independently:
no Vs for 2 seconds
2 consecutive cycles without Vs
pacing support for x out of 8 cycles without Vs (programmable number, default
setting: 3 out of 8)
15 switches per hour permanently switches to DDD(R) until 24:00 h of the
same day.
The criterion which is met first triggers the switch. Regardless of the criterion,
switching is AV-synchronous. The ventricle is always paced either using the
programmed AV delay or with the AV delay of 450 ms depending on the situation
and especially depending on the rate.
Switching criterion:
2 seconds without Vs
In the example shown below, the 2-second criterion is met first. The 2-second
timer always starts at the sensed ventricular event. The ventricular pause is
greater than 2 seconds because the ventricular stimulus is AV-synchronous.
In this example, the ventricular pause is about 3 seconds. Due to the fact that
the rate is low (1500 ms), the 2-second criterion is met earlier than the 2-cycles-
without-Vs criterion.
Example: Ventricular pause at 40 ppm
Switching criterion:
2 consecutive cycles
without Vs
In the example shown below, the 2-cycles-without-Vs criterion is met earlier than
the 2-second criterion because the cycle length is 857 ms (70 ppm).
Example: Ventricular pause at 70 ppm
As / Ap As / Ap As / Ap As / Ap
Vp
DDD(R) ADI(R)
Skipped Vp at 450 ms
Programmed
AV delay
1 cycle 450 ms
AV delay
AV delay
450 ms
2 s
Vs
As / Ap As / Ap As / Ap As / Ap
Vs
Vp
2 s
DDD(R) ADI(R)
Programmed
AV delay
Skipped Vp at 450 ms
AV delay
450 ms
1 2
91 Bradycardia Therapy
Switching criterion:
Programmable number X of
8 cycles without Vs
In order to avoid irregular ventricular rhythms while in ADI(R) mode, only one
programmable number of cycles is permissible without intrinsic activity. The
default setting is 3 out of 8 cycles. If this criterion is met, it switches to DDD(R)
mode.
Example: 3 out of 8 cycles without Vs
The 8 cycle interval is fixed and is not flexible like the X out of Z criterion in mode
switching.
Summary
As/Ap As/Ap As/Ap As/Ap As/Ap As/Ap As/Ap As/Ap As/Ap
Vs Vs Vs Vs Vs
Vp
1 2 3
1 2 3 4 5 6 7 8
Cycles without Vs, skipped Vp at 450 ms
Programmed
AV delay
DDD(R) ADI(R)
Example:
3 out of 8 cycles without ventricular sense
Number of
cycles
7 8 1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8
ADI(R) ADI(R) DDD(R)
...
Cycles with Vs
Cycles without Vs
Switching criteria: ADI(R) to DDD(R)
DDD(R) - ADI(R)
mode
ADI(R)
functionality
AV Delay:
450 ms
up to two
cycles w/o Vs
2 consecutive cycles without Vs
3* out of 8 cycles without Vs
Interval w/o ventricular support of 2 s
> pace at the next possibility
with AV synchrony
DDD(R) - ADI(R)
mode
DDD(R)
functionality
AV Delay: as
programmed
More than 15 switches/h will suspend Vp Suppression until 12:00 p.m.
The next Vs Continuity test will occur 30 seconds later.
*Range: 1...(1)...4; Default: 3

92 Bradycardia Therapy
Vp suppression and
mode switching
Every time the DDD(R)-ADI(R) mode is activated, mode switching is automatically
activated with the possibility of switching to DDI(R) mode. Mode switching is
available in the background regardless of the current Vp suppression mode
function in order to protect the patient against high ventricular rates.
The function is deactivated for the duration of mode switching.
Whenever the mode switching criterion is met, the algorithm switches to the
DDI(R) mode regardless of the current functioning of the DDD(R)-ADI(R) mode.
The algorithm remains in DDI(R) mode until the resynchronization criterion is met.
Subsequent to resynchronization from within mode switching, the algorithm
always switches to DDD(R) and not to ADI(R) mode to work with defined conditions
after a tachycardia.
Statistics recordings of
Vp suppression
You will find the statistics for Vp suppression under Statistics Sensing
Vp suppression.
The Vp suppression statistics records the actions of these functions numerically
and chronologically:
240-day trend for the duration of ADI(R). Like all long-term trends, this is a
rolling recording in which one data point is recorded per day. The portion is
shown as a percentage of one day for the ADI(R) mode. The earliest recordings
are overwritten if recording continues for more than 240 days.
Counter for successful switching to the ADI(R) mode. All successful Vs conti-
nuity searches since the last transmission of the permanent program are
counted.
Counter of Vs continuity searches. The absolute number of scan cycles since
the last permanent program transmission is counted.
It has to be taken into consideration that there are several functions with higher
priority than Vp suppression. After switching back, Vp suppression starts in the
DDD(R) mode with a new Vs continuity search.
This is the reason why the number of Vs continuity searches and successful
switches can be unexpectedly high in the case of 100% sensing spread throughout
the day.
DDD(R) - ADI(R) mode
ADI(R) funcionality
AV Delay: 450 ms
up to two cycles w/o Vs
DDD(R) - ADI(R) mode
DDD(R) functionality
AV Delay: as programmed
Activation of
Vp suppression
Vs search algorithm
Vp Suppression and Arrhythmia Mode Switch
A
V
condu
c
t
io
n
AV blo
c
k
Mode switch DDI(R)
Atrial tachycardia Atrial tachycardia
93 Bradycardia Therapy
Vp suppression and
high rates
Vp suppression is not connected to specific rate limits like, for example, capture
control.
In the case of high rates, the AV delay would be longer than the VA interval if
the AV delay is set to a maximum of 450 ms.
Therefore, the AV delay of 450 ms is reduced depending on the rate to avoid
unfavorable hemodynamic situations in the case of high rates.
The exact AV delay dependent on the rate when Vp suppression is activated can
be viewed in the diagram of the dynamic AV delay function.
The maximum AV delay is still 450 ms at 100 ppm and is reduced incrementally,
thus reaching a base of 300 ms at 140 ppm, which remains set even at higher rates.
Vp suppression interactions
with other functions
and actions
As already mentioned above, there are several functions with a higher priority than
Vp suppression.
The Vp suppression function is interrupted if a function with higher priority starts.
After automatic reactivation of Vp suppression, the function always initially works
in DDD(R) mode regardless of which mode was active when Vp suppression was
interrupted.
The following algorithms, partial functions and actions interrupt the Vp suppres-
sion function:
Pacing threshold search of atrial and ventricular capture control
Mode switching
PMT detection
Programming head application
Long-term deactivation when ERI is reached
94 Bradycardia Therapy
Setting Ventricular Pacing Suppression
Purpose The ventricular pacing suppression function serves to promote the intrinsic
ventricular rhythm with AV conduction.
Description The function can only be set in the DDD(R)-ADI(R) mode. The device adapts to
conduction changes. In the case of intrinsic conduction, the device works in a mode
similar to AAI.
The pacemaker switches back to the DDD(R) mode under the following conditions:
2 consecutive cycles without Vs
X(1-4) out of 8 intervals without ventricular support
Interval without ventricular support for 2 s
More than 15 conversions per hour deactivate the function until 24:00 h
Activating ventricular
pacing suppression
Proceed as follows:
Software interface Vp suppression
Effect On the long term, right-ventricular pacing has been shown to cause asymmetrical
ventricular contraction due to the unphysiological cardiac conduction. The Vp
suppression function promotes intrinsic conduction by extending the AV delay.
On the long term this serves to prevent desynchronization of the ventricle and
development of congestive heart failure.
Step Action
1 Select Parameters Bradycardia Mode.
2 Select the mode [DDD-ADI] or [DDDR-ADIR]. The Vp suppression
function is now activated and the Bradycardia window displays
the value ON. Select the function parameters.
3 Set the value for Pacing suppression to 6 consecutive Vs.
The default setting is 6.
4 Set the value for Pacing support to 3 out of 8 cycles.
The default setting is 3.
95 Bradycardia Therapy
IRSplus - Promoting Intrinsic AV Conduction
Purpose The IRSplus (Intrinsic Rhythm Support) function is intended to support the heart's
intrinsic rhythm. All parameters of the AV hysteresis functions are set in a single
step. The objective is to maintain spontaneous AV conduction of the patient's heart
as long as possible. This causes a natural contraction procedure and prevents
unnecessary pacing of the ventricle.
IRSplus range of values The value range is preconfigured as follows after activating the IRSplus function:
* At high rates of over 100 ppm, the AV hysteresis interval is shortened to 300 ms
maximum at rates of over 140 ppm.
Activating IRSplus Activate the IRSplus function and automatically activate AV hystereses in the
dynamic AV delay, proceed as follows:
Graphic display of
the AV hysteresis
In the Dynamic AV delay window, the AV hysteresis is displayed in the AV delay
diagram as a dotted line.
Note: IRSplus and AV hystereses cannot be activated if Vp suppression has
been activated.
Function IRSplus Standard
AV hysteresis 400* ms OFF
AV scan 5 cycles
AV repetitive 5 cycles
Note: IRSplus allows for long AV delays. Therefore, turn on PMT protection in
order to avoid tachycardia, which may be induced by the device.
Step Action
1 Make sure PMT protection is activated to prevent pacemaker-
mediated tachycardias. Select Parameters Bradycardia
Refractory period/Blanking PMT ON.
2 Select Parameters Bradycardia Dynamic AV delay
AV hysteresis to choose IRSplus.
Select IRSplus. The AV hystereses are automatically set in the
dynamic AV delay.
3 Confirm the settings with [OK] to accept the values.
96 Bradycardia Therapy
5.3.4 Refractory and Blanking Times
What's in this section? This section contains the following topics:
Topic Page
Timing of the Atrial Refractory Times (ARP, PVARP) 97
Setting the Blanking and Refractory Periods 100
97 Bradycardia Therapy
Timing of the Atrial Refractory Times (ARP, PVARP)
Abbreviation list Abbreviations and their meanings in graphics and text:
Definition: Physiologic
refractory period
Time period after depolarization in which a heart cell is in the refractory state and
cannot be depolarized again:
150 to 220 ms depending on the heart rate
Abbreviation Meaning
BI Basic interval
AV AV delay
As Atrial sense
Ap Atrial pace
ARP Atrial refractory period
AUR Atrial upper rate interval
Vs Ventricular sense
Vp Ventricular pace
VRP Ventricular refractory period
PVARP Post-ventricular atrial refractory period
PVARP(ext). Extended post-ventricular atrial refractory period
FFPp Far-field protection after pace
UTI Upper tracking interval
Vp(WKB) Ven. pace delayed by Wenckebach response
Vp(SW) Ven. safety pace within the safety window
Vp(BU) Ven. pace as backup pace
Vs(AVC) Ven. sense within the AV control window
98 Bradycardia Therapy
Definition: Atrial refractory
period in the device's timing
The atrial refractory period (ARP) starts with an intrinsic sense or pace.
Each of the following atrial events (As, As(AV), Ap, Ap(AUR) and As(PVARP))
starts an atrial refractory period (ARP).
Mode-controlled atrial
refractory period setting
Timing with
the atrial refractory
period setting AUTO
The atrial refractory period (ARP) is automatically configured in addition to
the AV delay.
The atrial refractory period (ARP) is 225 ms minimum. It is also used after
AsPVARP.
Atr. refractory period
Basic interval
AV interval


V
p


V
p
180 180 350
A
p
A
s
AV AV
BI BI
ARP ARP
Setting Mode
AUTO DDD(R), DDD-CLS, DDI(R), VDI(R),
VDT(R), DDD(R)-ADI(R)
300 ... (25) ... 775 ms AAI(R), AAT(R), DDT
AS AS AS
PVARP PVARP PVARP
ARP
FFPp FFPp FFPp
AV AV AV
VRP VRP VRP
UTI UTI UTI
VP VP VP
ARP
BI BI BI
ARP
225 ms-FFP < AV delay < 225 ms 225 ms-FFP > AV delay AV delay > 225 ms
99 Bradycardia Therapy
Post-ventricular atrial
refractory period (PVARP)
The post-ventricular atrial refractory period function prevents atrial pacing from
being triggered directly after a ventricular event. This prevents a pacemaker-
mediated tachycardia (PMT).
In all P-synchronous modes (e.g., DDD), a PVARP starts in the case of the
following events: Vp, Vp (WKB), Vp (SW), Vp (BU)
In all R-synchronous modes (e.g., DDI), a PVARP starts in the case of the
following events: Vp, Vp (SW), Vp (BU), PVC, Vs and Vs (AVC).
AUTO PVARP After ending a pacemaker-mediated tachycardia (PMT), PVARP and PVARP after
PVC are automatically extended by 50 ms.
The limit for PVARP is:
Value of the VA criterion + 50 ms.
Minimum automatic setting: 175 ms
If no pacemaker-mediated tachycardia (PMT) is detected within 7 days, the
Auto PVARP function automatically reduces PVARP and PVARP after PVC by 50 ms.
A
p
A
p
A
s


V
p


V
s
V
E
S
180 420
153 350 473
Atr. refractory period
PVARP
Far-field protection
Basic interval
AV interval
ARP ARP ARP
PVARP
PVARP(ext.)
FFPp FFPs FFPs
BI BI
BI
AV AV AV VA(EI)
100 Bradycardia Therapy
Setting the Blanking and Refractory Periods
Purpose Blanking and refractory periods can prevent false inhibition of the device by inter-
ference potentials. This protects the patient. The following interference potentials
may inhibit the device:
Retrograde conductions
Remote potentials
Afterpotentials
Description
Automatic PVARP
If pacemaker tachycardia (PMT) is verified, the post-ventricular atrial
refractory period is automatically extended by 50 ms.
The PVARP is reduced by 50 ms every seven days without a verified PMT.
The maximum value of the PVARP is calculated based on the set VA criterion
plus 50 ms.
The PVARP is extended by 150 ms following premature ventricular
contractions. The PVARP is technically limited to 600 ms after PVC.
Automatic atrial refractory period
The atrial refractory period (ARP) is automatically connected to the AV delay.
The ARP does not drop below 225 ms.
In triggered pacing modes, the parameter can be set to the value
'Automatic' or set to fixed values.
Refractory periods
Events that occur during the refractory period and are sensed by the device
have no effect on device timing. This does not include algorithms used for
prevention in the case of atrial tachyarrhythmias (e.g., mode switching).
Far-field protection
Events that are sensed in the far-field protection window do not affect
device timing. These events are visible in the marker channel.
101 Bradycardia Therapy
Setting the blanking and
refractory periods
Proceed as follows:
Software interface
Step Action
1 Select Parameters Bradycardia to choose the program
parameters.
2 Select [Refractory period/Blanking]. A window with the adjustable
parameters and a graphical overview of the general effect of
refractory periods and blanking times is displayed.
3 Confirm the changes with [OK]. The set blanking periods in the
atrium and ventricle are displayed in the parameter window.
Note: When you activate the Auto PVARP function, PMT protection is
automatically activated.
102 Bradycardia Therapy
5.4 Atrial and Ventricular Capture Control
What's in this section? This section contains the following topics:
Overview The functions of atrial capture control are designed as follows:
Continuous monitoring of effective atrial pacing
Periodic determination of the atrial pacing threshold
Verification of stimulus response
Periodical adaptation of the pacing amplitude
The functions of ventricular capture control are designed as follows:
Continuous monitoring of effective ventricular pacing
Periodic determination of the ventricular pacing threshold
Verification of stimulus response
Beat-to-beat adaptation of the pacing amplitude
Objective The purpose of ventricular capture control is to continually monitor the pacing
process and to adjust the pacing amplitude to threshold changes.
Because the pacing amplitude is periodically (atrial) or continuously (ventricular)
being adjusted to the threshold, it is possible to optimally apply the energy reserves
of the pacemaker and thus ensure reliable patient care.
Section Topic Page
5.4.1 Atrial capture control 103
5.4.2 Ventricular Capture Control 111
5.4.3 Configuring Capture Control, Parameters, and FAQ 121
Note: Leads that generate high polarization artifacts are not suitable for
ventricular capture control.
103 Bradycardia Therapy
5.4.1 Atrial capture control
What's in this section? This section contains the following topics:
Topic Page
Atrial Capture Control - Overview 104
Automatic Threshold Measurement 105
104 Bradycardia Therapy
Atrial Capture Control - Overview
Overview Objective of atrial capture control
Function
Advantages
Objective of
atrial capture control
Lead aging, changes to the medication, lead dislodgement and pathological
changes can result in changes to the pacing threshold.
Automatic algorithms permit follow-ups to be carried out as efficiently as possible.
Automatic measurement of the ventricular threshold and the corresponding
automatic adaptation of the ventricular pacing amplitude are functions, which
have already been used for many years in clinical practice.
This type of automatic algorithm is thus advantageous for measurement of the
atrial threshold and the corresponding adaptation of the atrial amplitudes.
Function The dual-chamber systems in this device line dispose of an algorithm for atrial
capture control, which is based on periodical observation and differentiation of
atrial signals. The algorithm automatically measures the atrial threshold at a
defined time and adapts the pacing amplitude when needed.
Advantages The following advantages arise from the use of atrial capture control:
Remote follow-up:
Follow-up can be performed as remote follow-up with BIOTRONIK Home
Monitoring. The atrial capture control function is one of the requirements
for this.
Safety:
The atrial amplitude is automatically adapted to increased atrial thresholds,
so that atrial exit blocks are avoided.
Longevity:
The lowest atrial pacing amplitude value is determined by atrial capture
control. It is automatically adapted to the current atrial threshold in each case
and a safety margin is added. Low values for the atrial pacing amplitude
increase the service life of the device.
105 Bradycardia Therapy
Automatic Threshold Measurement
Overview Testing principle
Determining the intrinsic rate and performing overdrive pacing
Searching for the pacing threshold
Confirming the pacing threshold
Automatic Active Capture Control
Programming suggestions
Testing principle When measuring the atrial threshold, the pulse amplitude is reduced until pacing
in the heart no longer triggers a response. As soon as there is no atrial stimulus
response, the intrinsic atrial rate takes over and generates a sensing marker,
which can be produced using possible retrograde conduction if there is no intrinsic
atrial rate.
Therefore, the atrial threshold can also be identified in the case of sinus arrest
(no intrinsic atrial rate) by means of retrograde conduction.
Determining the intrinsic
rate and performing
overdrive pacing
The atrium is paced in order to be able to identify the loss of stimulus response at
a certain amplitude.
Therefore, the intrinsic rate is subjected to overdrive pacing amounting to 20% to
ensure the atrium is being paced artificially. The intrinsic rate is identified using the
average rate of the last 4 cycles in each case.
Conditions for overdrive pacing
Intrinsic rate 65 beats per minute + 20% = test pulse rate of 78 ppm
If ... Then ...
the average atrial rate is higher
than the programmed pacing rate
(= 108 ppm)
the atrial pacing threshold test is
carried out at a rate which corresponds
to the average intrinsic rate + 20%.
the average atrial rate is lower than the
programmed pacing rate
the atrial pacing threshold test is
carried out at the pacing rate + 20%.
the average atrial rate lies above
108 beats per minute
the test cannot be carried out at the
present time and the atrial pacing
amplitude remains at the current
value.
Intrinsic rhythm 65 bpm
Test start
Test 78 ppm
25 mm/s 25 mm/s
A
s


9
1
7
A
s


9
2
9
A
s


9
2
9
A
s


9
1
3
A
s


9
2
8
A
s


9
1
7

A
s


9
2
1
A
s


9
2
9
A
p


7
6
5
3.0 V A
p


7
6
9
3. 0 V A
p


7
6
5
V
p


7
6
4
V
p


9
2
9
V
p


9
2
9
V
p


9
1
7
V
p


9
1
7
V
p


9
5
5
V
p


9
2
4
V
p


9
2
5
V
p


9
1
3
V
p


7
6
5
V
p


7
6
5
V
p


7
6
9
3.0 V A
p


7
6
8
3.0 V
106 Bradycardia Therapy
Searching for the
pacing threshold
Mode and AV delay during the test
DDI mode:
Pacing in the DDI mode prevents tracking of retrograde conducted P waves,
which can occur if the atrial stimulus response is lost during the pacing
threshold test.
In the DDD mode, retrograde conducted P waves can trigger pacemaker-
mediated tachycardias. Therefore, the test is carried out in DDI mode.
AV delay = 50 ms
After the AV delay of 50 ms, ventricular pacing is carried out, starting an
atrial blanking of 150 ms. During blanking, the cardiac pacemaker does not
evaluate the atrial signals for the test.
To allow sensing of the atrial rhythm as early as possible and prevent retro-
grade conduction, the AV delay has to be as short as possible. This ensures
that intrinsic atrial events are not blanked in the atrial channel.
Pacing threshold search using amplitude reduction
The pacing threshold search begins at the programmed start amplitude
(default setting: 3.0 V). The amplitude is reduced here in 0.6 V increments,
until 2 intrinsic atrial events are sensed within 5 cycles (2 of 5).
After the first loss of stimulus response (2 of 5), the device switches back
to the amplitude, at which the last stimulus response took place, in order to
perform a more detailed search.
The test amplitude is decreased in increments of 0.1 V until the device detects
a loss of 2 of 5 possible stimulus responses for the second time.
This completes the pacing threshold search.
Below 0.6 V, the search is always performed in 0.1 V increments.
The criterion 2 of 5 was selected because statistically, at least 2 events within
5 cycles can be sensed outside the far-field protection interval.
Start amplitude: 3.0 V; amplitude reduction: 0.6 V increments; loss of stimulus
response at 0.6 V; beginning of detailed search at 1.2 V; amplitude reduction:
0.1 V increments; loss of the stimulus response at 0.7 V; pacing threshold at 0.8 V
3.0
2.4
1.8
1.2
0.6
1.2
1.1
1.0
0.9
0.8
0.7
Threshold
A
m
p
l
i
t
u
d
e

[
V
]
107 Bradycardia Therapy
Amplitude rate per test amplitude, analysis algorithm and synchronization pulse
Each test amplitude is delivered and analyzed 5 times with the same pacing
energy for the duration of 5 cycles.
After sensing 2 intrinsic events within 5 cycles, the test sequence is terminated
prematurely because ineffective pacing has occurred and the value has fallen
below the pacing threshold.
After each test pulse sequence with the same pacing energy, a synchronization
pulse is delivered to ensure that the AV synchrony is restored after possible loss
of pacing.
For technical reasons, the synchronization pulse is even delivered without a
loss of stimulus response.
If there is no stimulus response, the synchronization pulse has an additional
pacing energy of 0.6 V in the test sequence with larger increments (0.6 V).
If a stimulus response occurs, the synchronization pulse has the same pacing
energy as the test pulse.
In the test sequence with smaller increments (0.1 V), the pacing energy of
the synchronization pulse is increased by 0.5 V.
Premature ventricular contractions have no impact on the test.
Diagram of the test and synchronization pulses with stimulus response (capture)
and without stimulus response (non-capture)
Example: Synchronization pulse, 5 stimuli at 3 Vs and a synchronization pulse
Test sequence Amplitude of the synchronization pulse
Reduction in increments of 0.6 V
with stimulus response
Pacing energy the same as test amplitude
Reduction in increments of 0.6 V
without stimulus response
Pacing energy the same as test amplitude
+ 0.6 V
Reduction in increments of 0.1 V
with and without stimulus response
Pacing energy the same as test amplitude
+ 0.5 V
Capture
Non Capture Non Capture
Capture
Test amplitude
Capture
Sync. Pace
1.8 1.2 0.6 1.1 1.0
1.8* 1.2*
1.6* 1.2 1.5
25 mm/s 25 mm/s
V
p


7
6
5
V
p


7
6
9
V
p


7
6
9
V
p


7
6
4
V
p


7
6
5
V
p


7
6
5
V
p


7
6
8
A
p


7
6
8
3.0 V A
p


7
6
5
3.0 V A
p


7
6
5
3. 0 V A
p


7
6
9
3.0 V A
p


7
6
9
3.0 V A
p


7
6
9
2.4 V A
p


7
6
4
3.0 V
Synchronisation pulse
5 Stimuli at 3.0 V Next amplitude 2.4 V
108 Bradycardia Therapy
Example: Loss of capture at 0.6 V; only atrial markers outside the far-field
protection interval (150 ms after Vp) are evaluated.
Example: Beginning of the detailed search in 0.1 V increments, switching from
0.6 V to 0.1 V increments of decrementation
The threshold determined at the beginning is confirmed as follows:
1st step:
Pacing pulses of 0.3 V above the pacing threshold are delivered within a testing
period of 5 atrioventricular pacing intervals.
2nd step:
Another test cycle of 5 atrioventricular pacing intervals is carried out at 0.3 V
below the pacing threshold.
The pacing threshold is considered verified if a stimulus response is identified
in the first step and loss of the stimulus response is confirmed in the second
step.
Event in FFP
Far-field protection (FFP)
atrial IEGM
Sinus rhythm gets through due to loss of capture
First intrinsic event
detected outside FFP
Second intrinsic event
detected
>threshold above 0.6 V
V
p


7
6
5
V
p


7
6
8
V
p


7
0
5
V
p


6
7
9
V
s


4
0
6
0.6 V A
p


7
6
9
0.6 V A
p


7
6
4
0.6 V A
p


7
6
9
0.6 V
A
p


1
0
8
5
25 mm/s 25 mm/s
A
p


7
6
5
1.7 V A
p


7
6
9
1.1 V A
p


7
6
5
V
p


7
6
4
V
p


7
6
5
V
p


7
6
5
V
p


7
6
5
V
p


7
6
8
V
p


7
6
9
V
p


7
6
8
V
p


7
6
5
V
p


7
6
5
V
s


4
0
6
V
p


7
6
9
V
p


7
6
5
V
p


7
6
9
A
p


7
6
8
1.2 V 1.2 V
A
p


7
6
5
1.2 V
A
p


7
6
8
1.2 V
A
p


7
6
5
1.2 V
A
p


1
0
8
0
0.6 V
A
p


7
6
9
0.6 V
A
p


7
6
9
0.6 V
A
p


7
6
4
0.6 V
A
p


7
6
9
1.2 V
Sync Pace Sync Pace Capture at 1.2 V Loss of capture at 0.6 V Next amplitude 1.1 V
Note: If the pacing threshold is s 0.3 V, pacing markers of 0 V are set in the IEGM.
109 Bradycardia Therapy
Example: Verification test: stimulus response at 0.7 V (= pacing threshold),
loss of the stimulus response at 0.6 V, (pacing threshold +/- 0.3 V)
Pacing threshold measurement using retrograde conduction in the case of
sinus arrest
Atrial capture control also works if there is no atrial intrinsic rate.
Retrograde conducted P waves, which are caused by ventricular pulses if there
are no intrinsic atrial signals, suffice for analysis.
Example: Sinus arrest with retrograde conduction time of 220 ms
25 mm/s 25 mm/s
V
s


4
0
6
V
p


7
6
8
V
p


7
6
5
V
p


7
6
5
V
p


7
6
8
V
p


7
6
9
V
p


7
6
9
V
p


7
6
5
V
p


7
6
5
V
p


7
6
5
V
p


6
7
5
V
p


7
6
4
V
p


6
8
9
A
p


7
6
5
1.0 V
A
p


7
6
5
1.0 V
A
p


7
6
5
1.0 V
A
p


7
6
5
0.4 V
A
p


7
6
8
0.4 V
A
p


7
6
9
1.0 V
A
p


1
0
8
5
0.4 V
A
p


7
6
9
1.0 V
A
p


7
6
8
1.0 V
A
p


7
6
9
1.0 V
A
p


1
0
7
7
0.6 V
A
p


7
6
8
1.2 V
confirmed:
loss of capture at 0.4 V
Sync Pace Sync Pace Sync Pace
L
o
s
s

o
f

c
a
p
t
u
r
e

a
t

0
.
6

V
confirmed:
capture at 1.0 V
25 mm/s 25 mm/s
V
p


8
3
9
V
p


8
3
9
V
p


8
3
9
V
p


8
3
9
V
p


8
3
9
V
p


8
3
5
V
p


8
3
5
V
p


8
3
5
V
p


8
3
5
V
p


8
3
5
A
p

8
3
5
1.2 V A
p

8
3
9
1.8 V A
p

8
3
5
1.2 V A
p

8
3
5
1.2 V A
p

8
3
5
1.2 V A
p

8
3
5
1.2 V A
p

8
3
5
0.6 V A
p

8
3
9
1.2 V A
p

8
3
9
1.2 V A
p

8
3
9
1.2 V A
p

8
3
9
0.6 V A
p

8
3
9
1.8 V
Loss of capture at 0.6 V
retrograde conduction
ventricular IEGM
atrial IEGM
110 Bradycardia Therapy
Automatic Active
Capture Control
The atrial pacing amplitude is adapted by adding the programmed safety
margin (default setting 1.0 V, adjustable) to the measured pacing threshold.
If no atrial pacing threshold test could be carried out (e.g., at an intrinsic
rate > 108 bpm), the current atrial amplitude remains valid.
If atrial capture control is deactivated (e.g., in the case of interferences of a
unipolar lead), the atrial amplitude is calculated by adding the test output
amplitude and the safety margin. Default setting: 3.0 V + 1.0 V = 4.0 V.
Programming suggestions The value of the Threshold test start parameter does not influence the success
of the test (as opposed to ventricular capture control), but reduction makes it
several seconds faster.
The test is repeated daily at the programmed time.
Note:
If atrial capture control is deactivated, an error message is displayed in the
Follow-up window and an event message is generated for BIOTRONIK Home
Monitoring.
Unsuccessful measurements of atrial capture control are shown in the Home
Monitoring statistics as gaps.
Note: Make sure there is a sufficient difference between the threshold and the
value of the threshold test start parameter, so that pacing threshold changes
can be monitored following implantation.
111 Bradycardia Therapy
5.4.2 Ventricular Capture Control
What's in this section? This section contains the following topics:
Topic Page
Ventricular Capture Control - Overview 112
Signal Analysis 115
Automatic Threshold Measurement 117
Verification of Stimulus Response 119
112 Bradycardia Therapy
Ventricular Capture Control - Overview
Components of the algorithm
Characteristics
Manual/automatic determination of the pacing threshold
Terms
Purpose During implantation and follow-up, the necessary pulse amplitude required to
depolarize the myocardial tissue is usually measured. This minimum pulse ampli-
tude is identified as the pacing threshold. The impulse amplitude is set twice as
high as the measured pacing threshold as standard. The purpose of ventricular
capture control is to adjust the pacing amplitude via a change in the pacing
threshold.
Components of
the algorithm
The algorithm is comprised of 3 components:
Signal analysis
Measurement of the pacing threshold with amplitude setting
Verification of stimulus response
The first two components occur periodically. Verification of the stimulus response
occurs with every stimulus. If the entire ventricular capture control mode is set to
ON, all 3 components will run one after the other.
113 Bradycardia Therapy
Overview of the algorithm's components
The algorithm is based on the comparison of the signals from the evoked response
and the polarization artifact.
Characteristics The function comprises of the following characteristics:
The function periodically measures the pacing threshold, automatically adjusts
the pulse amplitude and offers a programmable safety margin.
The function checks the effectiveness of every ventricular pacing pulse on a
beat-to-beat basis and implements a back-up pulse in the case of an ineffective
stimulus (non-capture).
The differences in the signal morphology and the evoked response and the
polarization artifact are used to differentiate between effective and ineffective
pacing.
Manual/automatic
determination
As the manual method of determining the pacing threshold occurs at long
intervals (e.g. every 12 months), a large safety margin must be selected in order
to ensure an effective pacing.
An automatic method, which continually checks the efficiency of pacing and
periodically determines the pacing threshold (e.g. every 12 hours), can manage
with a smaller safety margin, as the pacing amplitude is continuously adjusted
to the demand. A smaller safety margin may lead to less power consumption
and an extended longevity of the device.
Successful pacing Unsuccessful pacing
Ventricular Capture Control
114 Bradycardia Therapy
Terms The following table lists and describes all terms that are used in connection with
ventricular capture control.
Term Description
Evoked response Intracardiac signal which arises through the excita-
tion of the myocardium tissue. The evoked response is
independent from the pacing amplitude and the
pacing threshold.
Polarization artifact Noise which arises between the pacing lead and the
myocardial tissue after delivery of the pacing pulse.
The polarization artifact is dependent on the pacing
amplitude, the structure of the lead tip, and the
manner of the implantation.
Signal analysis A component of the function which periodically
determines whether the evoked response has been
correctly recognized and whether the polarization
artifact's amplitudes are small enough. If the signal
analysis determines that the signal is not useable,
then the other components of the function cannot
be activated.
Threshold search A component of the function which periodically deter-
mines the pacing threshold. The pacing threshold
search can only be performed after a successful
signal analysis.
Verification of stimulus
response
A component of the function which classifies every
stimulus (beat-to-beat) as effective or ineffective.
Ineffective stimulus A single ineffective, ventricular stimulus without
depolarization (non-capture)
Safety margin The difference between the pacing threshold and
the programmed impulse amplitude is referred to
as the safety margin.
Loss of capture The function detects a loss of capture if a series of
ventricular stimuli at different AV delays cannot
depolarize the tissue (max. 3 successive ineffective
stimuli).
Threshold test start The set amplitude at which signal analysis and pacing
threshold measurement start. The signal analysis is
also carried out for every amplitude.
Back-up pulse Pacing pulse of increased energy following an ineffec-
tive stimulus
115 Bradycardia Therapy
Signal Analysis
Purpose This sub-function analyzes the signal quality of the ventricular evoked stimulus
response when the stimulus is effective, and the polarization artifacts when the
stimulus is ineffective.
The function ensures that only undisturbed and suitable signals are evaluated.
The signal analysis function works up to a ventricular rate of 100 bpm.
How signal analysis works The signal analysis sub-function works in the following way:
Sequence Description
1 The device measures with a constant, maximum pacing amplitude
(Threshold test start) for a duration of 5 cycles. The AV delay is
shortened to 50 ms after pacing and to 15 ms after sensing.
2 After another 5 cycles, a second pulse is delivered with the same
amplitude 100 ms after the effective stimulus. This pacing reaches
refractory tissue and thus does not evoke a stimulus response.
This makes it possible to determine the sole polarization artifacts
of the lead.
3 The average signal from the 5 measurements is used to compare
the effectiveness of the pacing pulse (signal morphology) and to
classify it as effective or ineffective.
Note: If the signal quality is classified as insufficient, then the pacemaker tempo-
rarily and automatically switches to safety pacing until a successful measure-
ment can be conducted.
If insufficient signal quality is measured repeatedly, then the function is deacti-
vated and the pacemaker switches to permanent safety pacing.
The signals (evoked response and polarization artifact) can be changed by
changing the pulse width, the pacing polarity and the pulse amplitude under
Ventricular Capture Control Threshold test start [V] so that the signal quality
is possibly sufficient.
116 Bradycardia Therapy
Example: Checking signal quality, analysis of evoked responses
Possible scenarios during
signal analysis

25 mm/s 25 mm/s
A
p
A
p
A
p
A
p
A
p
A
p
V
p


9
9
6
V
p


9
9
8
V
p


9
9
8
A
p


9
9
5
A
p


9
9
5
A
p


9
9
5
A
p


9
9
9
A
p


9
9
9
A
p


9
9
9
3.0 V V
p


9
9
9
3.0 V V
p


9
9
9
3.0 V V
p


9
9
5
3.0 V V
p


9
9
9
V
p

3.0 V 3.0 V V
p

3.0 V V
p

3.0 V V
p

3.0 V V
p

3.0 V
Test start
Start threshold test:
first stimulus
Evaluation signal quality check: 5 single stimuli; 5 doubled simuli
If... Then...
after initial activation of
ventricular capture control,
signal analysis is not
completed successfully,
the function is immediately deactivated and the
pacing amplitude is set to the threshold test start
amplitude value.
By changing parameters (see note above), the
signal quality can be changed so that analysis is
permanently successful.
after initial activation,
signal analysis is completed
successfully, but subse-
quently completed without
success,
the function is suspended and the pacing
amplitude is set to a safe value.
This value is composed of the last measured
threshold + maximum safety margin of 1.2 V.
Signal analysis is performed again at the next
programmed time. The procedure is carried out
up to three times.
the third consecutive
signal analysis remains
unsuccessful,
the function will be deactivated and the pacing
amplitude set to a safe value (threshold test
start amplitude + 1.2 V).
Afterwards, the ventricle capture control
can only be manually reactivated with the
programmer.
117 Bradycardia Therapy
Automatic Threshold Measurement
Purpose The sub-function Pacing threshold measurement enables the pacing threshold
with the resulting stimulus to be automatically determined. The ventricular
threshold is periodically measured and the pacing amplitude is adjusted if
necessary.
Prerequisite Only after the signal quality has successfully been checked can the pacing
threshold measurement and capture control functions be executed.
How the pacing threshold
measurement works
The threshold is determined as follows:
Sequence Description
1 After successful verification of the signal quality, the pacing
amplitude is incrementally decreased with each pace.
The amplitude is reduced, first in larger increments (0.6 V),
then in smaller increments (0.1 V).
Each amplitude is tested with 1 stimulus.
The AV delay is shortened to 50 ms after pacing and to 15 ms
after sensing.
2 The incremental decrease of the pacing amplitude continues until
a loss of stimulus response (ineffective stimulus) is measured.
The last effective pacing amplitude that is measured is accepted
and saved as the pacing threshold value.
3 A safety pulse with an increased pulse width energy of 1 ms is
delivered after each ineffective ventricular stimulus. This leads to
continuous effective pacing.
Analysis of the evoked response Analysis of the polarization artefact Threshold measurement
Back-up pulse
(sequence classified
as capture)
Back-up pulse
non capture (A)
Threshold
determined with
0.1 V precision
Back-up pulse
non capture (B)
. . .
. . .
1.8 V 1.2 V 0.6 V 1.2 V 1.1 V 1.0 V 0.9 V
3,0 V 3,0 V 3,0 V 2,4 V
118 Bradycardia Therapy
Automatic determination of
the pacing threshold

Example: The pacing threshold test was carried out in less than 20 seconds.
Programming suggestions The standard value to start the threshold test is 3.0 V. To further increase the
likelihood that the test will be successful, this value can be lowered to 2.4 V.
Also, in case of a low pacing threshold, the pulse width can be reduced from 0.4 ms
to 0.3 ms .
The search type is set to time of day and 2 o'clock in the morning by default in
the software. This serves to minimize the impact that a highly fluctuating intrinsic
rate has on the algorithm.
If ... Then ...
during the first pulse amplitude
decrement (0.6 V), a single
ineffective stimulus is detected,
the pacing value is set at the previous value
minus 0.1 V and the amplitude is then
reduced by 0.1 V in order to determine
the pacing threshold.
during the second pulse amplitude
decrement (0.1 V), a single
ineffective stimulus is detected,
the preceding measured value is taken to
be the pacing threshold.
an ineffective stimulus is
detected again,
up to 2 more stimuli are delivered with
the same pacing amplitude.
2 of 3 stimuli are ineffective, the preceding measured value is taken to
be the pacing threshold.
The pacing amplitude is then set to the
pacing threshold plus the programmable
safety margin.
A
p
A
p
A
p
A
p
A
p
A
p
A
p
V
p

9
9
8
3.0 V V
p

9
9
5
2.4 V V
p

9
9
9
V
p

9
9
5
A
p

9
9
5
A
p

9
9
5
A
p

9
9
9
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p

9
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A
p

9
9
9
A
p

1
4
5
6
A
p

1
5
2
5
1.8 V
V
p 1.2 V V
p

9
9
9
1.2 V V
p

9
9
5
1.1 V
V
p

1
0
5
0
0.9 V V
p

9
9
8
1.0 V V
p

9
9
5
0.8 V 0.6 V V
p

9
9
9
V
p
V
E
S

9
0
5
0.6 V V
p
0.7 V 0.6 V
V
p 0.6 V
V
E
S

4
7
6
25 mm/s 25 mm/s 25 mm/s
Loss of capture 0.6 V
Loss of capture 0.6 V
> threshold 0.7 V
0.6 V-steps 0.1 V-steps
119 Bradycardia Therapy
Verification of Stimulus Response
Overview Functionality (verification of the stimulus response)
Back-up pulse
Algorithm for fusion beat discrimination
Fusion beat discrimination in 3 stages
Purpose This sub-function allows the pacing amplitude to be continuously checked. Verifi-
cation of the stimulus response is possible up to a ventricular rate of 110 bpm.
Functionality The pacing effectiveness is checked after each ventricular stimulus.
Back-up pulse The algorithm checks the effectiveness of every single ventricular stimulus. If an
ineffective stimulus is detected, a back-up pulse with more energy will be delivered
within 130 ms. The energy of this stimulus is increased in that the pulse width is
increased to 1.0 ms.
The maximum pulse duration that can be programmed with capture control is
0.4 ms, which causes the back up pulse to provoke a depolarization. Thus, the
energy of the back-up pulse is 150% higher than the energy of the previous
ineffective stimuli.
Sequence Description
1 When pacing is effective, the current settings are retained.
2 If the stimulus is ineffective, then a back-up pulse with increased
energy is delivered after a maximum of 130 ms. This is carried out
at the same amplitude and an increased pulse width.
3 If a series of 3 consecutive ventricular paces, even after the
AV delay has been changed (with atrial-controlled pacing modes or
the basic rate in ventricular-controlled pacing modes), does not
produce effective pacing, the signal analysis function is started
first and a new threshold search is executed.
4 If pacing continues to be ineffective, the pacing amplitude is
increased in order to secure effective pacing. Due to this automatic
capture control, it is possible to select a small safety margin,
which can combine lower energy consumption with safe pacing.
5 After the monitoring interval has elapsed, the threshold search
function is automatically executed. The pacing amplitude is set to
the threshold value plus the safety margin.
Note: The verification of the stimulus report function does not work when the
programming head or magnet is applied.
120 Bradycardia Therapy
Diagram of the signal analysis when the stimulus is not effective
Algorithm for fusion beat
discrimination
Fusion beats can significantly compromise signal morphology, which in some
cases may cause such fusion beats to be classified as ineffective stimulation.
A fusion beat occurs when the spontaneous depolarization could still not be
detected before the stimulus delivery from the pacemaker. An overlay of the
spontaneous complex with the stimulus thus results.
Fusion discrimination is important during the pacing monitoring phase. During the
signal check and the pacing threshold measurement, the AV delay is reduced to
50 ms in order to avoid fusion beats.
Fusion beats do not compromise the safety of the algorithm, but release back-up
impulses which would otherwise not be necessary. During stimulus response
verification, ineffective pacing may be detected for two reasons:
Actual ineffective pacing
Fusion beat
Fusion discrimination
in 3 stages
Apart from the signal analysis and the threshold measurement, fusion discrimina-
tion is started with each case of ineffective pacing. Fusion discrimination occurs in
3 stages:
Sequence Description
1 If an AV hysteresis is programmed, then the AV delay is prolonged
to the value of the programmed AV hysteresis when an ineffective
stimulus is detected. If no AV hysteresis is programmed, the
AV delay is prolonged for one cycle using the average AV hysteresis
(+110 milliseconds). Extension of the AV delay serves to support
the intrinsic rhythm and effectively discriminate a fusion beat.
The AV delay remains extended as long as ventricular events are
being sensed. If no intrinsic event is sensed, the pacemaker paces
after the extended AV delay.
2 Return to the normal AV delay. If the stimulus is effective after the
extended AV delay, the pacemaker returns to the normal AV delay.
If an ineffective stimulus is sensed in the normal AV delay, the pace-
maker switches to the third stage of fusion beat discrimination.
3 Reduction of the AV delay to 15 or 50 ms after As or after Ap. If effi-
ciency is detected in two stimuli, the pacemaker reverts to regular
pacing verification. If pacing was detected as ineffective even after
the shortened AV delay, a new signal analysis with threshold
measurement is initiated.
121 Bradycardia Therapy
5.4.3 Configuring Capture Control, Parameters, and FAQ
What's in this section? This section contains the following topics:
Topic Page
Setting Atrial and Ventricular Capture Control 122
Ven. und atr. Capture Control - Programmable Parameters 125
FAQ - Frequently Asked Questions 126
Comparison of Atrial and Ventricular Capture Control 128
122 Bradycardia Therapy
Setting Atrial and Ventricular Capture Control
Overview Atrial capture control
Automatic pacing threshold search
Confirmation of the found pacing thresholds
Ventricular capture control
Signal analysis
Automatic pacing threshold search
Verification of stimulus response
Calling capture control
Activating capture control
Activating automatic threshold measurement (ATM)
Setting parameters
Displaying further data
Displaying the status
Atrial capture control Atrial capture control is not based on a beat-to-beat algorithm, which monitors
the evoked response of the stimulus, but on event markers in the atrium and their
statistical analysis.
Periodic and automatic measurement of the pacing threshold
Confirmation of the found pacing threshold
Adaptation of the amplitude if ATM has not been set
Ventricular capture control The efficacy of a stimulus is monitored by a beat-to-beat algorithm and the pacing
energy is continuously adapted in case of pacing threshold fluctuations. Ventricular
capture control consists of the following sub-functions:
Signal analysis
This function analyzes the signal quality of the ventricular evoked stimulus
response when the stimulus is effective, and the polarization artifacts (when
the stimulus is ineffective). The function ensures that only undisturbed suitable
signals are evaluated. Only after the signal quality has been successfully tested
can the pacing threshold search and testing of the stimulus response functions
be executed.
Automatic pacing threshold search
The pacing threshold search function makes it possible to determine the pacing
threshold with the resulting stimulus automatically and periodically.
Verification of stimulus response
This function allows the pulse amplitude to be continuously verified. The pacing
effectiveness is checked after each ventricular stimulus.
Adaptation of the amplitude if ATM has not been set
This function continuously adapts the pulse amplitude to the results of
automatic pacing threshold measurement. Automatic increase of the pulse
amplitude by an adjustable safety margin guarantees safe pacing.
123 Bradycardia Therapy
Calling capture control Proceed as follows:
Windows with the following adjustable parameters are opened for atrial and
ventricular capture control respectively:
OFF; ON; ATM (Automatic Threshold Monitoring)
Threshold test start
Safety margin
Search type
Interval
Time of day
The following additional parameters can be set for atrial capture control:
Min. amplitude
Step Action
1 Select Parameters Bradycardia to initiate the function.
2 Select [Capture control] to set the function's parameters.
Select the [A] group box for atrial capture control or the [V] group
box for ventricular capture control.
124 Bradycardia Therapy
Activating capture control Capture control can be activated and configured separately for the atrium and
ventricle. Proceed as follows:
Setting parameters Proceed as follows:
Displaying additional data Additional capture control function data are displayed:
Note:
A note is displayed if the amplitude is higher than the measured pacing
threshold plus the safety margin
Pacing threshold:
The pacing threshold that is measured and used in the permanent program is
displayed.
Date of pacing threshold measurement
Time of pacing threshold measurement
Step Action
1 Select [ON] to activate the function with all subfunctions or [OFF] to
deactivate it.
Select [ATM] to only monitor and record the threshold without
tracking pulse amplitude.
!
!
CAUTION
When selecting the ATM or OFF options, make sure that a sufficient safety margin
is selected when manually setting the pacing amplitude since there is no auto-
matic tracking of the pulse amplitude for these options.
Step Action
1 Select [Min. amplitude] to prevent the value from dropping below a
specified minimum ventricular amplitude. This parameter is preset
to 0.7 V for the ventricular amplitude.
2 Select [Threshold test start] to enter the initial value with which
the pacing threshold is measured.
3 Select [Safety margin] to set another value for the safety margin.
Safety pacing is carried out at the amplitude of the most recently
measured pacing threshold plus the programmed safety margin or
the programmed initial amplitude. The larger value of the pacing
threshold influences safety pacing.
4 Select [Search type] to determine the times or intervals during
which the automatic threshold search is executed continuously.
Intervals or times can be alternately selected.
5 If you have selected [Interval] as the search type, then enter the
period in which the pacing threshold measurement is performed in
hours.
If you have selected [Time of day] as the search type, then enter
the time of the pacing threshold measurement. Then the interval is
24 hours in each case.
125 Bradycardia Therapy
Ven. und atr. Capture Control - Programmable Parameters
Parameter overview
Function options The following options are available for the capture control function:
Parameter Range of values and explanations
Capture control ON; OFF; ATM (monitoring only)
Minimum
amplitude (atr.)
0.5 ... (0.1) ... 4.8 V
The minimum amplitude and threshold test start
(maximum atrial amplitude) parameters prevent a certain
value of the ventricular amplitude from being exceeded or
undershot during the threshold search.
Minimum
amplitude (ven.)
The value 0.7 V is a fixed preset. It is not programmable
and is not displayed for ventricular capture control.
The minimum ventricular amplitude and threshold
test start (maximum ventricular amplitude) parameters
prevent a certain value of the ventricular amplitude from
being exceeded or undershot during the threshold search.
Threshold test
start (maximum
ventricular and
atrial amplitude)
2.4; 3.0; 3.6; 4.2; 4.8 V
Search type Interval; time of day
The search type parameter determines the times or inter-
vals during which the signal quality is continuously verified
and the automatic threshold search is executed. Intervals
or the times can be alternately selected.
Interval 0.1; 0.3; 1; 3; 6; 12; 24 hours
Time of day 00:00 to 24:00 h, min. time unit of 10 min.
Safety margins of
the ventricular
and atrial pacing
amplitudes
Atr. safety margin: 0.5 ... (0.1) ... 1.2 V
Ven. safety margin: 0.3 ... (0.1) ... 1.2 V
The value of the pacing amplitude, which is set by the
function, is made up of the most recently measured pacing
threshold plus the configured safety margin or the
programmed initial amplitude + 1.2 V for the ventricle
and 1 V for the atrium if the pacing threshold is higher
than the initial amplitude (Threshold test start).
Options Explanations
Capture control ON; OFF; ATM (monitoring only)
ON option This option activates all sub-functions: The pacing
threshold is monitored and recorded; the pacing energy is
adapted continuously for the ventricle and periodically for
the atrium. This is done with the following:
Signal analysis (ventricle only)
Automatic pacing threshold search
Verification of stimulus response (ventricle only)
OFF option This setting deactivates the entire capture control func-
tion.
Automatic
Threshold
Monitoring (ATM)
option
The pacing threshold is monitored and recorded at
programmable time intervals. This is done with the
following:
Signal analysis (ventricle only)
Automatic pacing threshold search
Accordingly, no continual adaptation of the pacing
amplitude is performed.
!
!
CAUTION
When selecting the ATM or OFF option, make sure that a sufficient safety margin
is selected when setting the pacing amplitude since there is no automatic
tracking of the pacing amplitude for this option.
126 Bradycardia Therapy
FAQ - Frequently Asked Questions
Overview The following questions regarding the behavior of capture control in particular
situations will be answered:
When is the pacing threshold measured?
During which events is ACC temporarly disabled?
How does ACC behave on magnet application?
How does ACC behave on reaching ERI?
What is the effect of a fusion beat?
What should be observed when pacing single-chamber devices?
When are the atrial and
ventricular pacing
thresholds measured?
In addition to the pacing threshold search after a loss in depolarization (loss of
capture), the measurements are carried out as follows:
At a defined time of day
The pacing threshold measurement is conducted, in order to ensure an exact safety
margin also in the case of slow changes in the pacing threshold.
If the pacing threshold measurement is initiated by a sudden loss of depolarization,
the counter causing the next periodical measurement is reset.
Which atrial and ventricular
events cause temporary
deactivation?
During the following events, automatic adaptation of the amplitude and control of
the pacing effectiveness are temporarily turned off and automatically reactivated
after the end of the event:
Mode switching
Sustained interference rate behavior
Rate > 110 ppm
The last measured pacing threshold plus safety margin is greater than the max.
amplitude (Threshold test start)
For the duration of the event, the amplitude is set at the last measured pacing
threshold plus 1.2 volts (highest safety margin). If the algorithm is temporarily
interrupted, then the status OK is displayed during interrogation.
What is the response to
magnet and programming
head application?
The process is momentarily interrupted by magnet application during the signal
analysis or the pacing threshold measurement and is restarted after 3 4 cycles
following magnet application if magnet response is set to SYNC (synchronous).
Monitoring of pacing success is interrupted during magnet application if magnet
response is set to ASYNC (asynchronous).
During communication with the programming head, the function is disabled and is
reactivated when the programming head is removed.
How does ACC behave on
reaching ERI?
When ERI is reached, capture control is deactivated. The amplitude is set to the
most recent automatically measured pacing threshold plus 1.2 V in the ventricle,
while the amplitude in the atrium is set to the most recent automatically measured
pacing threshold plus 1 V.
127 Bradycardia Therapy
How do fusion beats
affect ventricular
capture control?
If pacing is classified as ineffective because of a fusion beat, a back-up-impulse is
delivered. Fusion beats do not compromise safety, however, they lead to unneces-
sary (back-up) stimulation. In the following cycles, the AV delay can be extended or
shortened to 15/50 ms (after As/Ap) in order to avoid fusion beats and to prevent
the detection of loss of depolarization (3 consecutive ineffective Vp) because of
fusion beats.
Which status messages
are displayed?
Status description:
What actions can be taken
in the case of an inactive
ventricular status?
If insufficient signal morphology is the reason for unsuccessful measurement, then
it can be remedied by changing the following parameters:
Amplitude (Threshold test start, e.g. 2.4 V)
Pulse width (e.g. 0.3 ms)
Polarity (from unipolar to bipolar)
Changing these parameters can result in successful measurement.
What should be observed
when pacing single-
chamber devices for atrial
or ventricular application?
In order to ensure pacing in single-chamber devices during signal analysis and
threshold verification, the device paces at a rate that is 10 ppm higher than the
intrinsic rate.
Display Description
OK The capture control or ATM function is activated and operates
without errors.
Ventricular
capture control
disabled
During the first 28 days after implantation, the device attempts
to activate ventricular capture control permanently.
After these 28 days, the device disables the ventricular capture
control permanently if 3 consecutive measurements have failed
or if too many measurements have been made per day.
Possible reasons for this status are:
If a polarization artifact that is too large or ineffective
pacing at maximum amplitude is sensed during initial
signal analysis after programming, then the device sets the
amplitude to the value programmed for threshold test start
and indicates the status disabled.
If there are 3 consecutive unsuccessful signal analyses,
then the amplitude is set to the programmed value for
threshold test start (polarization artifact) or to the
programmed value for threshold test start plus 1.2 V
(ineffective pacing at max. amplitude) and ventricular
capture control is disabled.
If loss of depolarization is detected 25 times within
24 hours, then the amplitude is set to the value
programmed for threshold test start plus 1.2 V and the
function is deactivated.
Atrial capture
control disabled
Atrial capture control is disabled if the replacement indication
ERI is reached or if lead impedance is outside the permitted
value range (from 100 to 2500 Ohms).
Pending The device could not yet determine a valid pacing threshold.
Further measurements will be made.
Note: Activation of capture control via auto-initialization or manual activation
sometimes fails during implantation because the implantation damage raises
the pacing thresholds. In the first weeks following implantation, the pacing
threshold drops again so that the capture control can be activated either auto-
matically or manually.
128 Bradycardia Therapy
Comparison of Atrial and Ventricular Capture Control
A comparison of differences between atrial and ventricular capture control
Atrial capture control Ventricular capture control
The pacing threshold is determined
using sensing markers
The pacing threshold is determined by
beat-to-beat measurements of evoked
responses
Reduction of the start amplitude of the
pacing threshold test (Threshold test
start) has no impact on the test result
and makes the test faster.
Reduction of the start amplitude of the
pacing threshold test (Threshold test
start) from 3.0 V to 2.4 V increases the
chances of success because the polar-
ization artifacts are smaller in the
leads. In addition to this, it makes the
test faster.
Safety margin: 1.0 V (default setting) Safety margin: 0.5 V possible because of
beat-to-beat monitoring with backup
pacing in the case of ineffective pacing
Switching on using auto-initialization.
The first measurement is performed at
the programmed time (default setting:
02:00).
Switching on using auto-initialization.
The first measurement takes place
immediately.
129 Bradycardia Therapy
5.5 Rate Adaptation
What's in this section? This section contains the following topics:
Section Topic Page
5.5.1 Pacing Modes 130
5.5.2 Physiological Rate Adaptation (CLS Function) 132
5.5.3 Rate Adaptation Using the Accelerometer 139
130 Bradycardia Therapy
5.5.1 Pacing Modes
What's in this section? This section contains the following topics:
Topic Page
Rate-Adaptive Modes 131
131 Bradycardia Therapy
Rate-Adaptive Modes
Rate adaptation principles The device uses two independent principles for rate adaptation:
Physiological rate adaptation via closed loop stimulation
Rate adaptation using the accelerometer
An overview of
rate adaptation
The programmable rate-adaptive modes can be categorized as follows:
Rate adaptation
Closed loop stimulation Accelerometer
DDD-CLS
VVI-CLS
DDDR
DDIR
DOOR
DVIR
DDDR-ADIR
VDDR
VVIR
VVTR
VDIR
V00R
AAIR
AATR
AOOR
132 Bradycardia Therapy
5.5.2 Physiological Rate Adaptation (CLS Function)
What's in this section? This section contains the following topics:
Topic Page
The Closed Loop Stimulation Principle 133
Individual Adjustment of CLS Parameters 134
CLS Safety Feature 135
Setting Closed Loop Stimulation 136
133 Bradycardia Therapy
The Closed Loop Stimulation Principle
The contraction dynamics of the myocardium vary depending on the patient's
exertion. The changes are characteristic and closed loop stimulation uses these
to generate a physiological pacing rate specific to the patient. This also applies
to the patient's mental stress.
The pacemaker evaluates the dynamics of the contraction of the myocardium
(inotropy) in a short time period after the beginning of ventricular excitation.
Impedance measurement is carried out with a ventricular lead and is primarily
dependent on the specific conductivity of a small volume surrounding the lead tip.
The impedance changes are characteristic for the ventricular contraction proce-
dure and directly proportional to the stress on the heart. The pacemaker calculates
the required pacing rate using a reference measurement with a reference imped-
ance curve recorded at rest. The CLS responds immediately at the beginning of
stress by using contractility as input information for rate adaptation. Therefore,
the combination with rate adaptation by accelerometer is not necessary.
Closed loop stimulation is self-calibrating and automatically adjusts to the
patient's situation within just a few minutes. Typically, there is no need to manually
fine-tune the system. Automatic fine-tuning is active during the entire operating
time of the pacemaker.
Among other things, pacing cycles with extended or shortened AV delays update
the reference impedance curves at regular intervals.
However, some individual cases (e.g. if the patient is extremely active or extremely
inactive) may require adjustment of the CLS.
Autonomic
nervous system
Myocardium
inotropy
Cardiac
output
Heart rate
Stroke volume
sbiotronik
Mean arterial
blood pressure
Sinus node
chronotropy
134 Bradycardia Therapy
Individual Adjustment of CLS Parameters
Overview The following parameters can be individually adjusted in the Extended CLS
settings window:
Vp required
CLS dynamics
Resting rate control
Vp required In the mode DDD-CLS, an AV hysteresis is set to support existing adequate intrinsic
AV conduction. For patients with inadequate or non-existent intrinsic AV conduc-
tion, it may be necessary to deactivate the AV hysteresis. The [Vp required]
parameter is activated for this.
CLS dynamics The factory settings for closed loop stimulation are made so as to ensure that the
majority of patients receive optimum rate dynamics. Adjustment is not usually
required.
However, the rate profile resulting from closed loop stimulation can vary greatly
from patient to patient. In individual cases, the rate dynamics can be optimized if
the rate distribution is inadequate.
The parameter [CLS dynamics] affects an internal device target rate, which
depends on the preset basic and maximum closed loop rate parameters. The
device internally controls rate adaptation so that 20% of the pacing events are
always above the internal target rate. If the CLS dynamics parameter is repro-
grammed, then increasing setting values result in rate distribution towards higher
middle rates and lower setting values result in rate distribution with lower rates.
Resting rate control This parameter limits the pacing rate attainable at rest to the programmable value
of, e.g., 20 ppm above the set basic rate. This serves to suppress unspecific rate
excursions at rest without limiting rate adaptation in cases of mental stress. This
can be switched off if a high rate limit is not desired from the clinical perspective.
The exact value depends on the relationship between the basic rate and the
maximum closed loop rate.
135 Bradycardia Therapy
CLS Safety Feature
The pacemaker regularly checks the requirements for correct closed loop stimu-
lation internally. If one of the requirements is not met, then closed loop stimulation
is interrupted. The accelerometer takes on rate adaptation for the duration of the
interruption. Once all requirements have been met, closed loop stimulation is auto-
matically activated again. The following events interrupt closed loop stimulation:
Automatic initialization of CLS
Mode switching
Ventricular fusion beats
Inadequate impedance values
Hardware and software errors
136 Bradycardia Therapy
Setting Closed Loop Stimulation
Overview
Setting closed loop stimulation and the maximum CLS rate
CLS parameters and default settings
Description of the CLS parameters
Changing CLS parameters
CLS response
CLS resting rate control
CLS Vp required
Setting ventricular CLS pacing
Selecting device
parameters
Select Parameters Bradycardia to choose the device parameters.
Setting closed loop
stimulation and the
maximum CLS rate
You can set the closed loop stimulation and the maximum closed loop rate as
follows:
Device parameter: DDD-CLS and the adjustment of AV delays and AV hystereses
Device parameter: Maximum closed loop rate
Step Action
1 Select [Mode] to be able to select the CLS pacing mode. The corre-
sponding window is opened.
2 Select [DDD-CLS] for example. A message window describes that
the AV delays and AV hystereses are automatically predefined and
optimized by the programmer. These default settings are intended to
support the intrinsic rhythm and prevent fusion beats.
3 Confirm the changes to AV delays and AV hystereses with [OK].
The selected CLS pacing mode is displayed in the parameter window.
4 Select [CLS [ppm]] to at least set the maximum closed loop rate of
the CLS parameters.
5 Select [Max. CLS rate [ppm]] to set the maximum pacing rate to the
desired value.
6 Confirm the changes with [OK]. The selected maximum value for the
closed loop rate is displayed in the CLS [ppm] parameter.
137 Bradycardia Therapy
CLS parameter preferences The CLS parameters are set as follows:
Maximum closed loop rate: 120 ppm
CLS dynamics: Medium
The resting rate control can be configured and is set to +20 ppm.
CLS pacing is required: No
CLS parameters In general, it is only necessary to adjust the closed loop rate to meet the individual
needs of the patient. All other CLS parameters usually do not have to be changed.
However, CLS parameters can be changed if necessary.
Description of
the CLS parameters
The meanings of the individual CLS parameters are described briefly in the
following:
Type Description
CLS response The rate profile resulting from closed loop stimulation can
differ widely depending on individual requirements. In indi-
vidual cases, the rate dynamics can be optimized if rate
distribution is not adequate. CLS dynamics determines how
the profile of rate distribution can be changed. The setting
Very high moves the rate profile to higher values, whereas
the setting Very low moves the rate profile to lower values.
CLS resting
rate control
The resting rate control serves to limit the pacing rate
possible during resting and hence enables stable rate
adaptation.
CLS Vp required In the pacing mode DDD-CLS, an AV hysteresis is entered
as a default value to support existing adequate intrinsic
AV conduction. If ventricular pacing is switched on using
the 'CLS Vp required' parameter, then the AV hysteresis is
switched off and ventricular pacing is promoted.
Note: If the patient has intermittent, adequate intrinsic
AV conduction, then this parameter should not be repro-
grammed.
138 Bradycardia Therapy
Changing CLS parameters Proceed as follows to change one of the default CLS parameters:
Setting ventricular
CLS pacing
For patients with inadequate or non-existent intrinsic AV conduction, it may be
necessary to deactivate the AV hysteresis. The CLS Vp required parameter is
activated for this.
Step Action
1 You have set the CLS pacing mode and the CLS window is currently
displayed.
2 Select [CLS expert options] to change the default values for closed
loop stimulation. A window opens with the following parameters:
CLS response
CLS resting rate control [ppm]
CLS Vp required
3 You can now change the default CLS parameters.
Step Action
1 Select [CLS Vp required].
2 Note in the case of intrinsic AV conduction: If the patient has inter-
mittent, adequate intrinsic conduction, then this parameter should
not be reprogrammed. Select [Yes] to deactivate the hysteresis
function.
As an alternative, you can change the default value of the
[AV hysteresis] parameter in the [Dynamic AV delay] window.
3 Confirm the settings for sensing intrinsic ventricular events
with [OK].
4 Confirm the CLS settings with [OK].
139 Bradycardia Therapy
5.5.3 Rate Adaptation Using the Accelerometer
What's in this section? This section contains the following topics:
Topic Page
The Principle of Rate Adaptation via Accelerometer 140
Maximum Activity Rate 140
Sensor Gain 141
Automatic Sensor Gain 142
Sensor Threshold 142
Rate Increase 143
Rate Decrease 143
Sensor Simulation 144
Rate Fading 145
Setting Rate Adaptation and Sensor/Rate Fading Parameters 147
140 Bradycardia Therapy
The Principle of Rate Adaptation via Accelerometer
Purpose Sensor-controlled rate adaptation allows an adjustment of the pacing rate to
changing metabolic needs at rest and during exertion.
Technical realization The pacemakers are equipped with an acceleration sensor (accelerometer) that is
integrated into the hybrid circuit. This sensor produces an electric signal which is
constantly processed by analog and digital signal facilities.
If a rate-adaptive mode is programmed, then this affects an adjusted increase of
the basic rate, depending on the exertion level of the patient.
Due to the integration of the sensor in the hybrid circuit, it is not sensitive to static
pressure on the pacemaker housing.
Description The pacing rate increases at the onset of exercise to the sensor determined rate.
It slowly returns to the basic rate when exercise is no longer sensed.
Sensing and inhibition remain active during sensor-controlled operation. In case of
high pacing rates, however, the refractory period may cover a majority of the basic
interval, resulting in asynchronous pacing.
Maximum Activity Rate
Description Regardless of the sensor's detected signal amplitude, the pacing rate will not
exceed the programmed maximum activity rate.
The programmed value applies only to the maximum pacing rate during sensor-
controlled operation and is independent of the upper tracking rate.
Note: In the DDIR and DVIR modes, lower maximum sensor rates result than
those indicated here, depending on the selected AV delay. The respective values
are indicated by the programmer.
The shorter the selected AV delay is, the higher the maximum sensor rates can
become.
Rate/
ppm
Rest Exercise Rest
150
60
150 ppm
125 ppm
100 ppm
Time
141 Bradycardia Therapy
Sensor Gain
Definition The sensor gain designates the factor by which the electric signal of the sensor is
amplified before subsequent signal processing occurs.
Purpose The programmable sensor gain permits adaptation of the desired rate adaptation
to the individually variable signal strengths.
Description The optimal parameter setting is achieved when the desired maximum pacing rate
is reached during maximum exertion.
Before adjusting the sensor gain, the rate increase, rate decrease, and maximum
sensor rate parameters must be checked for their suitability with respect to the
individual patient.
If the rate increase is not sufficient during high levels of physical exertion, the
sensor gain should be increased. On the other hand, the sensor gain should be
reduced if high rates are obtained at low levels of exertion.
Note: Apart from the manual adjustment of the sensor gain, an automatic sensor
gain function is available (see the "Automatic Sensor Gain" section).
Optimum gain
setting
Gain setting
too low
Gain setting
too high
Max.
sensor
rate
Max.
exertion
Basic
rate
Min. Max.
exertion
Max.
exertion
Min. Min.
142 Bradycardia Therapy
Automatic Sensor Gain
Description The manually programmable sensor gain is supplemented by an automatic sensor
gain function. When the function is enabled, the pacemaker continuously checks
whether sensor gain optimally corresponds to the patient's needs and makes
adjustments if necessary.
The "automatic sensor gain" function checks daily whether 90% of the adjusted
maximum activity rate (MAR) have been reached for a total of 90 seconds. If this
occurs, it decreases the sensor gain by one increment.
If the "maximum activity rate" is not reached, the current setting will initially
remain unchanged. If the MAR is not reached within a period of 7 days, sensor gain
will be increased by one increment.
Sensor Threshold
Definition The minimum strength of the signals used for rate adaptation is determined with
the programmable sensor threshold. Sensor signals below this threshold do not
affect rate adaptation.
Purpose Through the programmable sensor threshold, a stable rate at rest of the patient
can be achieved by ignoring low-amplitude signals that have no relevance for
increased levels of physical exertion.
Setting the sensor
threshold
If the pacing rate at rest is unstable or reaches values that are above the basic rate,
the sensor threshold should be increased. On the other hand, the sensor threshold
should be reduced if a sufficient rate increase is not observed with slight exertion.
The sensor gain should be adjusted before setting the sensor threshold.
Sensor
gain
90% of max.
sensor rate
Reached
sensor rate
Days
Low threshold Mean threshold High threshold
100%
143 Bradycardia Therapy
Rate Increase
Description The rate increase parameter determines the maximum speed at which the pacing
rate rises if the sensor signal indicates increasing exertion.
A setting of the increase speed of 2 ppm per cycle means that the rate increases
e.g., from 60 ppm to 150 ppm in 45 cycles.
The programmed rate increase applies only to sensor-controlled operation and
does not affect the rate changes during atrial-controlled ventricular pacing.
Rate Decrease
Description The programmed rate decrease parameter determines the maximum speed by
which pacing is reduced if the sensor signal indicates decreasing exertion.
Setting the decrease speed to 0.5 ppm per cycle means that the rate decreases e.g.,
from 150 ppm to 60 ppm in 180 cycles.
In the modes DDIR and DVIR, the rate decrease is slightly slower than indicated
here (partly depending on the programmed AV delay).
Rate/ppm
Exercise Rest
0.1 ppm/cycle 0.2 0.4 0.8
0 100 200 300 400 500 600 700 800 900
150
60
Time/sec
144 Bradycardia Therapy
Sensor Simulation
Definition Even when a non-rate-adaptive mode is programmed, the sensor response is
recorded without being activated. In other words, the sensor simulation indicates
how the sensor would have responded if a rate-adaptive mode had been
programmed.
Purpose This function is helpful to find the optimum sensor settings and to compare the
sensor rate with the intrinsic rate.
Thus, sensor information is available prior to the activation of the rate adaptation,
which can be used to evaluate the sensor response (see also the "Sensor Histo-
gram" and "Activity Chart" sections under "Diagnostic Memory Functions").
Note: In the sensor simulation, you can only select sensor threshold values that
are greater than those used in the permanent program.
145 Bradycardia Therapy
Rate Fading
In all atrial-controlled modes, rate fading results in improved adjustment of the
pacemaker's pacing rate to the patient's intrinsic rate in the case of sudden
bradycardia.
If controlled rate fading is activated, then the pacemaker calculates the backup
rate, which is always active in the background. As soon as the rate decreases,
the pacemaker paces with the backup rate. With a certain delay, the backup
rate follows the intrinsic rate according to the programmable rate increase
(1...10 ppm/cycle) and the programmed rate decrease (0.1; 0.2; 0.5; 1.0 ppm/cycle).
These settings determine the sensitivity of the controlled rate fading.
After four consecutive As, the target rate for the backup rate is calculated as the
current atrial sensing rate minus 10 ppm. AES and Ap set the target rate to the
value of the basic or sensor rate.
In cases of sudden atrial tachycardia, which result in mode switching, the target
rate is set to the sensor or basic rate. The current pacing rate in the ventricle
results from the current value of the backup rate prior to the mode switching event.
If the pacing rate reaches the intrinsic rate upon rate decrease, then at least four
consecutive intrinsic cycles above the pacing rate are required to adjust the pacing
rate to the last intrinsic event.
This way rate fading is continued during intermittent sensed events.
146 Bradycardia Therapy
Four consecutive intrinsic sensed events are required to activate rate fading.
Individual sensed events have no impact on rate fading.
Table 2: Backup rate and target rate
Backup rate Rate at which the pacemaker paces in the case of sudden
rate decrease. It can be up to 10 ppm lower than the
intrinsic rate and follows the target rate up at 1...10 ppm
per cycle or falls at 0.1...1 ppm per cycle if the target rate is
lower than the current backup rate.
Target rate The target rate is either the current sensing rate minus
10 ppm or the sensor or basic rate. The backup rate follows
the target rate at the programmed rate increase or
decrease.
147 Bradycardia Therapy
Setting Rate Adaptation and Sensor/Rate Fading Parameters
Purpose Sensor-controlled rate adaptation adapts the pacing rate to changing metabolic
requirements at rest and under stress conditions.
Description The pacing rate increases at the onset of exertion to the rate determined by the
sensor. It slowly returns to the set basic rate when exertion is no longer detected.
The sensing and inhibition function remains active during sensor-controlled
operation. In case of high pacing rates, however, the refractory period may cover a
majority of the basic interval, resulting in asynchronous pacing. The individual
sensor parameters are described briefly in the following:
Type Explanation
Max. activity
rate
Regardless of the sensor's sensed signal amplitude, the
pacing rate will not exceed the set maximum activity rate.
The set value applies to the maximum pacing rate during
sensor-controlled operation and is independent of the
upper rate. The shorter the selected AV delay, the higher
the maximum activity rates can become. The respective
values are indicated by the programmer, e.g. in DDIR mode.
Sensor gain The programmable sensor gain designates the factor by
which the electric signal of the sensor is amplified. This
allows the rate adaptation to be modified for individually
variable signal strengths. The optimal setting is achieved
when the desired maximum sensor rate is reached during
maximum exertion.
Sensor
threshold
The minimum signal strength used for rate adaptation is
determined with the programmable sensor threshold.
Sensor signals below this threshold do not affect rate
adaptation. With the sensor threshold, a stable rate can be
achieved when the patient is at rest by ignoring low-ampli-
tude signals that have no relevance for increased levels of
physical exertion. If the pacing rate at rest is unstable or
reaches values that are above the basic rate, the sensor
threshold should be increased. On the other hand, the
sensor threshold should be reduced if a sufficient rate
increase is not observed with slight exertion.
Rate increase The set rate increase value determines the maximum
speed at which the pacing rate rises if the sensor signal
indicates increasing exertion. A setting of the increase
speed of 2 ppm per cycle means that the rate increases
from 60 ppm to 150 ppm in 45 cycles, for example. The
set rate increase applies only to the rate analyzed by the
sensor and does not affect the rate changes during atrial-
controlled ventricular pacing.
Rate decrease The set rate decrease parameter determines the maximum
speed by which pacing is reduced if the sensor signal
indicates decreasing exertion. Setting the decrease speed
to 0.5 ppm per cycle means that the rate decreases, from
150 ppm to 60 ppm in 180 cycles, for example. In DDIR
mode, the actual rate decrease is sometimes slower
depending on the set AV delay.
148 Bradycardia Therapy
Automatic gain The manually programmable sensor gain is supplemented by the automatic sensor
gain function. Every day, the device checks whether 90% of the set maximum
sensor rate has been reached for a certain total duration.
Sensor optimization A link to sensor optimization is located in the Sensor/Rate fading window.
For information on sensor optimization, see: Sensor Optimization, p. 230
Rate fading In all atrial-controlled pacing modes, controlled rate fading is intended to more
effectively adapt the device's pacing rate to the patient's intrinsic rate in cases of
suddenly occurring bradycardia. If controlled rate fading is activated, then the
device calculates the backup rate, which is always active in the background. As
soon as the intrinsic rate decreases, the device paces with the backup rate and
regulates the process of rate decrease using the backup rate and the rate fading
settings.
Selecting program
parameters
Select Parameters Bradycardia to choose the program parameters.
Setting rate adaptation Rate adaptation is programmed as follows:
If 90% of the set maximum sensor rate... Then the sensor gain...
is reached for at least 90 seconds (cumulative)
within one day,
is decreased by one step.
is not reached within seven days, is increased by one step.
Step Action
1 Select a rate-adaptive pacing mode (e.g. Mode DDDR).
2 Select [Sensor/Rate fading [ppm]] and set the maximum sensor
rate.
3 The following sequence is suggested for setting the sensor
parameters:
First check the parameters Max. activity rate [ppm],
Rate increase [ppm/cycle] and Rate decrease
[ppm/cycle] regarding the individual needs of the patient.
Then adjust the Sensor gain.
For subsequent fine tuning, adjust the Sensor threshold.
4 Select Rate fading ON to activate controlled rate fading.
5 Select [OK] and transmit the changed parameter settings to the
device using [Program].
149 Bradycardia Therapy
5.6 Antitachycardia Functions
What's in this section? This section contains the following topics:
Topic Page
Setting the Upper Rate 150
Atrial Upper Rate 152
Tachycardia Mode 154
Mode Switching 155
Setting Mode Switching 157
2:1 Lock-In Management 160
PMT Prevention 161
PMT Protection 162
Setting PMT Protection and VA Criterion 164
AV Control Window as PVC Lock-in Protection 166
Atrial Overdrive Pacing 167
Setting Overdrive Pacing 168
150 Bradycardia Therapy
Setting the Upper Rate
Purpose In atrial-controlled pacing modes of the dual-chamber devices, the upper rate,
along with the atrial refractory period, determines the maximum P-wave-triggered
ventricular rate. In all of the triggered pacing modes, the upper rate limits the
pacing rate triggered by sensing.
Therefore, sensible programming of the upper rates in combination with the
Refractory period parameter and the Mode switching function helps to prevent
conduction of atrial tachycardias to the ventricle.
Description The following parameters limit the maximum rates triggered by P waves:
Upper rate, ventricle
Upper rate, atrium
The response at the upper rate (WKB or 2:1) is automatically determined when
these parameters are set. They cannot be set directly.
WKB response occurs when the intrinsic rate exceeds the upper rate.
2:1 behavior occurs when the intrinsic rate exceeds the interval limit that
equals an interval of 60000 divided by the set AV delay plus PVARP.
Upper rate in the atrium Depending on the setting of the PVARP and the pacing interval, an atrial pace at the
end of the atrial refractory period could pace in the vulnerable phase of the atrium
and trigger an atrial tachycardia. Sensing of an atrial event within the PVARP is
detected as an AsPVARP by the device. After As(PVARP), an atrial upper interval is
started. 250 ms later, at the end of the atrial upper interval, safe atrial pacing
ensues outside the natural refractory period of the heart.
Selecting device
parameters
Select Parameters Bradycardia to choose the device parameters.
!
!
CAUTION
Pay special attention to patients with increased vulnerability to premature
atrial contractions, myopotentials or other interferences!
The upper rate must be set so that it can be tolerated by the patient for an
extended period of time.
151 Bradycardia Therapy
Setting the atrial/
ventricular upper rates
Set the upper rates as follows:
Displaying results In the Upper rate response [ppm] field, the behavior (2:1 or WKB) is
displayed that corresponds to the entered parameters of the upper rate and
the maximum attainable pacing rate.
Device parameters: Upper tracking rate [ppm], Wenckebach response
of [ppm] and Upper rate atrium [ppm].
Step Action
1 Select Upper rate response [ppm] to call up the function.
2 Select the parameter Upper tracking rate [ppm] and set
the desired value.
3 Select Upper rate atrium [ppm] and set 240 ppm as a fixed
value if required.
4 Confirm with [OK] to accept the settings.
152 Bradycardia Therapy
Atrial Upper Rate
Abbreviation list Abbreviations and their meanings in graphics and text:
Problem:
Atrial tachycardias
triggered by PAC
A premature atrial contraction (PAC) which occurs within the PVARP interval
depolarizes the atrium.
As a consequence, the atrial tissue is refractory for 150 - 220 ms.
Pacing in the vulnerable period depends on the following factors:
PVARP configuration
Current heart rate
Pacing in the atrium at the end of the refractory period can trigger an atrial
tachycardia.
Atrial pacing at the end of the PVARP in the vulnerable phase:
Abbreviation Meaning
Intrin. atr. refr. Intrinsic atrial refractory period
BI Basic interval
AV AV delay
As Atrial sense
Ap Atrial pace
ARP Atrial refractory period
AUR Atrial upper rate interval
Vs Ventricular sense
Vp Ventricular pace
VRP Ventricular refractory period
PVARP Post-ventricular atrial refractory period
As (PVARP) As in the PVARP starts the AUR (atrial upper rate)
FFPp Far-field protection after pace
VRP
Vp
AV
BI
FFPp
ARP ARP
PVARP
intrin.
atr. Refr.
As AsPVARP Ap
153 Bradycardia Therapy
Atrial upper rate
as a safety window
This function protects against atrial tachycardias. The safety window works in the
following way:
Each sensed atrial event during the PVARP (As(PVARP)) starts the atrial upper
rate (AUR).
During a sustained episode of AUR, an intended atrial pace (ARP) is shifted to
the end of the AUR.
The standard value for the atrial upper rate is 240 bpm (250 ms).
Shifting of the atrial stimulus to the end of AUR:
BI BI
Vp Vp
As As(PVARP) Ap
AUR
FFPp FFPp
ARP ARP ARP
PVARP PVARP
AV AV
VRP VRP
154 Bradycardia Therapy
Tachycardia Mode
Description The resulting tachycardia mode - either 2:1 or Wenckebach (WKB) - is auto-
matically displayed, depending on the combination of selected parameters.
The parameters that affect this are:
Upper tracking rate (UTR)
Atrial refractory period
WKB behavior A response similar to Wenckebach block (WKB mode) results if the selected upper
tracking rate is lower than the rate corresponding to the atrial refractory period.
If the upper tracking rate is exceeded in the WKB mode, the AV delay is continually
prolonged so that the ventricular pacing rate does not exceed the programmed
upper tracking rate.
If the selected upper tracking rate exceeds the rate corresponding to the atrial
refractory period, the maximum P-wave-triggered ventricular rate results exclu-
sively from the atrial refractory period, not from the programmed upper tracking
rate.
2:1 behavior If the length of the atrial cycle is shorter than the programmed atrial refractory
period, a 2:1 block, then a 3:1 block, etc., will result before the upper tracking rate
is reached in the ventricle (DDD mode, 2:1 behavior).
Resulting pacing rate If the resulting length of the spontaneous atrial cycle is shorter than the upper rate
interval in a rate-adaptive mode, the resulting pacing rate will depend on whether
the 2:1 rate has been exceeded or not. If this is the case, the sensor rate will be
used as the pacing rate.
If the 2:1 rate is not exceeded, the pacemaker will use a rate that lies between the
sensor rate and the rate determined by the atrial refractory period. In the latter
case, the cycle length switches between the sensor-defined interval and a shorter
interval, which is at least the amount of the ARP. Response then depends on the
response of the atrial rate to sensor rate and on the atrial refractory period.
Note: The extended AV delay in the WKB mode and the associated desynchroni-
zation of the atrium and ventricle increase the likelihood of detecting retrograde
P waves. This should especially be considered if the dynamic AV delay is to be
used for preventing or terminating (pacemaker-mediated) tachycardia, since the
WKB mode deactivates the dynamic AV delay when the upper rate is exceeded.
155 Bradycardia Therapy
Mode Switching
Description The device provides an algorithm which effectively prevents conduction of atrial
tachycardia into the ventricle. At the start of a tachycardia episode, the pacemaker
automatically switches from an atrial-controlled to a ventricular-controlled mode.
The following function is available for this:
Mode switching with X/Z-out-of-8 algorithm
Mode switching with
X/Z-out-of-8 algorithm
This X/Z-out-of-8 algorithm can be used to program activation and deactivation
criteria. This prevents unnecessary mode oscillations in the case of atrial extra
systoles or unstable atrial signals. In addition, this algorithm can be employed to
determine the speed at which a desynchronization and resynchronization of
ventricular depolarization occurs. This intervention rate can be programmed
within a range from 100 ... (10) ... 250 ppm.
In addition, the far-field protection interval after a ventricular event can be
programmed in a range from 100 220 ms. This prevents that any ventricular
events that are registered in the atrial channel are assessed for timing.
Available modes When detecting an atrial tachycardia, the pacemaker automatically switches to a
non atrial-controlled mode, i.e. from DDD(R) to DDI(R), from DDD(R)+ to DDI(R) or
from VDD(R) to VDI(R).
The mode switch can be programmed so that you can switch from a non-rate-
adaptive mode to a rate-adaptive mode, and vice versa. This serves to prevent an
undesirable rate drop to the basic rate in case of physical stress.
Time
DDD DDI (R) DDD
5 out of 8 5 out of 8
VDD VDI (R) VDD Pacing
mode
Atrial
rate
Mode switching
intervention rate
156 Bradycardia Therapy
Detection conditions An atrial tachycardia can be considered detected when the so-called X-out-of-8
switching criterion has been satisfied. The X value can be programmed within the
value range (X = 3 ... (1) ... 8).
Detection is based on the continual evaluation of the last 8 atrial intervals. If X-out-
of-8 intervals show an atrial rate above the programmed intervention rate, then the
switching criterion is fulfilled, and mode switching takes place automatically.
The pacemaker works in the programmed non-atrial mode until the deactivation
criterion (Z-out-of-8) has been fulfilled. The Z value can be programmed within the
value range (Z = 3 ... (1) ... 8). The last 8 consecutive atrial intervals are continually
evaluated. When Z-out-of-8 intervals lie below the programmed intervention rate,
the atrial tachycardia is considered to be over, and the pacemaker automatically
switches to the originally programmed atrial-controlled mode.
The X or Z counter is reset to zero after every completed switching.
The basic rate with
mode switching
It is possible to set a higher basic rate with mode switching to soften the unfavor-
able hemodynamic conditions during mode switching to some extent. This basic
rate can be programmed higher than the standard basic rate, which results in a
slight increase in cardiac output.
Table 3: Programmable parameters:
Rate stabilization with
mode switching
The frequency stabilization function with mode switching prevents ventricular rate
fluctuations by aiming for a target rate via rate fading. For further details on this
function, see: Setting the mode switching parameters, p. 158.
The basic rate with mode switching + 5 ... (5) ... +30 ppm
Note: In the CLS modes, the maximum closed loop rate is lowered in mode
switching to the sensor rate. If no rate-adaptive mode has been set up with mode
switching, then the CLS rate is slowly lowered to the basic rate in mode
switching.
157 Bradycardia Therapy
Setting Mode Switching
Overview Purpose
Description of the X/Z-out-of-8 algorithm
Selecting mode switching
Setting the mode switching parameters
2:1 lock-in protection
Purpose The mode switching function prevents conduction of atrial tachycardias to the
ventricle.
When an atrial tachycardia occurs, the device automatically switches from an
atrial-controlled to a ventricular-controlled mode.
The mode switching function with the X/Z-out-of-8 algorithm is especially suited
for patients with premature atrial contractions or irregular atrial signals to prevent
unnecessary mode oscillation. In addition to this, the algorithm can be used to
determine the speed at which desynchronization and resynchronization of ventric-
ular depolarization occurs.
Description of the
X/Z-out-of-8 algorithm
The mode switching function is based on the X/Z-out-of-8 algorithm:
Selecting mode switching To select the mode switching function, proceed as follows:
Atrial-controlled pacing
mode
Ventricular-controlled pacing mode after
mode switching
DDD(R) DDI(R)
VDD(R) VDI(R)
If... Then...
... X-out-of-8 intervals show an
atrial rate above the programmed
intervention rate,
... the switching criterion for the automatic
Mode switching function is fulfilled.
The device's timing switches to a ventricular
pacing mode.
... Z-out-of-8 intervals show an
atrial rate below the programmed
intervention rate,
... the resolution criterion is fulfilled.
The atrial tachycardia episode is considered
ended and the device's timing switches back
to the original atrial-controlled pacing
mode.
Step Action
1 Select Parameters Bradycardia to choose the function.
2 Select [Mode switching]. A window opens with options for behavior
during atrial tachycardia.
3 Activate the function using [ON] and configure the required
parameters.
158 Bradycardia Therapy
User interface Mode switching
Setting the
mode switching parameters
Set the mode switching parameters as follows:
Description of
2:1 lock-in protection
Among other things, 2:1 lock-in protection ensures the effective application of
mode switching. In cases of high atrial rates (atrial flutter) in combination with a
relatively long AV delay, it is possible that every second P wave regularly occurs in
the atrial far-field blanking period. In such cases, the device's timing behavior is
similar to a 2:1 block. For example, upon sensing atrial flutter at 280 bpm, the
ventricle is paced with 140 ppm. In order to terminate this block using 2:1 lock-in,
the AV delay is extended by the value of the far-field blanking time and it can be
switched to a ventricular-controlled pacing mode.
2:1 lock-in protection in combination with mode switching prevents mode switching
from not starting or from only starting at very high rates.
Step Action
1 Select [Intervention rate] to set the rate at which an atrial tachy-
cardia is sensed.
2 Select [Switch to] to determine the ventricular-controlled pacing
mode to be switched to.
3 Select [Criterion for activation] to determine the number of inter-
vals, the atrial rate of which must exceed the programmed inter-
vention rate for switching to occur.
4 Select [Resolution criterion] to determine the number of intervals,
the atrial rate of which must fall below the programmed inter-
vention rate in order to switch back.
5 Select [Change of basic rate] to set a rate for the duration of mode
switching that is higher than the standard basic rate. This slightly
increases the cardiac output.
6 Select [Rate stabilization during mode switching] to prevent the
ventricular rate from increasing or decreasing too quickly due to
the rate fading function.
The sensed atrial rate is not used to configure the required
ventricular rate. The sensed ventricular rate minus 10 bpm is used
instead. If no ventricular rate is sensed, then the basic rate is used
for mode switching.
7 Confirm with [OK] to accept the settings.
The selected ventricular-controlled pacing mode and the inter-
vention rate are applied and displayed in the displayed program.
159 Bradycardia Therapy
Setting 2:1 lock-in
protection
Set 2:1 lock-in protection as follows:
User interface Mode switching and 2:1 lock-in protection
Step Action
1 Select [Mode switching] and [ON] to activate the function.
2 Select [2:1 Lock-in protection] and [ON] to activate the function.
160 Bradycardia Therapy
2:1 Lock-In Management
Description In cases of high atrial rates (atrial flutter) in combination with a relatively large
AV delay, it is possible that every second P wave regularly occurs in the atrial
far-field blanking (FFB) period. In this case, the device detects only half of the
present atrial rate.
Therefore the behavior of the device is similar to a 2:1 block. The device paces in
the ventricle at a rate corresponding to half the atrial rate. At very high atrial rates,
this can cause physiologically unsuitable high ventricular rates.
Example: if atrial flutter takes place at a rate of 280 bpm, then pacing is performed
at a ventricular rate of 140 ppm.
This phenomenon is called 2:1 lock-in and can cause the patient serious discomfort
in cases of prolonged atrial flutter.
Impact on mode switching It is possible that, in a 2:1 situation such as this, the Mode Switching function will
not be started or will only be started at very high rates even though this would be
necessary. Therefore this function is intended to ensure effective application of
Mode Switching.
In order to terminate this behavior (2:1 lock-in), the AV delay is extended by the
value of the far-field blanking period and it can be switched to a ventricular-
controlled pacing mode. The algorithms of the 2:1 lock-in behavior are designed
as follows:
Suspicious phase
Confirmation
Termination
Suspicious phase The following criteria have to be met to fulfill the conditions of the 2:1 situation:
8 consecutive VpAs intervals have to occur
The actual ventricular rate has to exceed 100 ppm
If these conditions are met, then the 2:1 lock-in situation is considered confirmed.
Confirmation Detection is initiated as follows:
The AV delay is extended for a cycle of up to 300 ms to confirm the 2:1 lock-in
situation. Therefore events that were previously within the blanking period are
detected by the device as atrial refractory events.
Termination Termination is initiated as follows:
If the As-Ars interval reaches the mode switching rate, then the device immedi-
ately switches to the previously selected ventricular mode (without previously
waiting for the criteria for X/Z-out-of-8 mode switching).
If the rate corresponding to the As-Ars interval is greater than the mode
switching rate, then the AV delay is reduced to the current value in 50 ms incre-
ments.
Programmable
parameters
The following parameter is displayed in the mode switching window and can be set
there.
2:1 lock-in protection ON; OFF
161 Bradycardia Therapy
PMT Prevention
Purpose PMT prevention
PMT occurrence Pacemaker-mediated tachycardia is generally triggered by ventricle depolar-
ization that is asynchronous with atrial depolarization, e.g., as would be the
case in premature ventricular contractions (PVC).
The tachycardia is maintained retrogradely by VA conduction of stimulated
ventricle depolarization and antegradely by P-wave-triggered ventricular
pacing.
PMT prevention measures In the case of ventricular detection without previous atrial event, the following
intervals are restarted to prevent a PMT:
Basic interval
Post-ventricular atrial refractory period (PVARP)
Extending the atrial refractory period after a PVC
Result A retrograde P wave with a VA conduction period that is shorter than the PVARP is
not able to trigger a ventricular pace, and thus does not trigger a PMT.
Extending the atrial refrac-
tory period through PVARP
Subsequent to a ventricular event, the atrial refractory period is extended through
PVARP (if set) by the programmed value if the following events occur:
A ventricular sensed event without a preceding atrial event (PVC); pacing
modes: DDD(R), DDT(R), VDD(R), VDT(R)
A ventricular paced event which has not been triggered by a P wave; pacing
modes: VDD(R), VDT(R)
Note: An atrial refractory period extension through PVARP might be necessary in
the case of a short atrial refractory period in conjunction with a long VA conduc-
tion period in order to prevent the triggering of a PMT by asynchronous ventric-
ular depolarizations.
162 Bradycardia Therapy
PMT Protection
Overview PMT detection
PMT termination
Purpose Pacemaker-mediated tachycardias can also be caused by artifacts and atrial extra-
systoles. In such cases, the PMT protection algorithm offers functions to provide
both reliable detection as well as termination of PMTs. In this way, the hemo-
dynamically more favorable AV synchronization can rapidly be re-established.
PMT detection using
the VA criterion
The period between a ventricular event and the sensing of a retrograde P wave is
designated as the VA interval or retrograde conduction:
Vp-As interval (Vp = ventricular pace, As = sensed atrial event).
The VA delay is a programmable parameter (VA criterion) and can be set between
250 and 500 ms.
Detection algorithm A pacemaker-mediated tachycardia is recognized by the detection algorithm
when the following conditions are met:
If eight consecutive Vp-As intervals are shorter than the programmed VA
interval and
If the average standard deviation for the eight VpAs intervals is within the toler-
ance limit of the PMT stability criterion, then the device automatically extends
or shortens the AV delay by a defined value.
If the resulting Vp-As interval remains constant, the PMT is considered as
confirmed. The algorithm for terminating the PMT is automatically started.
Note: In cases where a low upper tracking rate and long AV delays have been
programmed, pacing rates slightly above the UTR may occur for a few cycles.
400
200
t (ms)
8 cycles
Limiting the PMT VA
Average VpAs interval
VpAs interval
VpAp, VsAs, VsAp interval
t (ms)
Cycles
Cycles
8 cycles
PMT VA tolerance range
Average VpAs interval
Absolute VpAs interval
+25
-25
0
163 Bradycardia Therapy
Termination algorithm The algorithm for terminating PMTs becomes effective:
Sequence Description
1 The PMT is terminated by extending PVARP by one pacing cycle.
2 This interrupts the retrograde conduction loop and hence the PMT.
Consequently the PVARP must be longer than the retrograde
conduction period after ventricular pacing or sensing.
3 AUTO PVARP: After ending a pacemaker-mediated tachycardia
(PMT), AUTO PVARP automatically extends the PVARP and the
PVARP after PVC by 50 ms.
The limit for the PVARP extension is:
Value of the VA criterion + 50 ms.
After 5 days without sensing a pacemaker-mediated tachycardia
(PMT), the AUTO PVARP function automatically reduces the PVARP
extension and the PVARP after PVC by 50 ms.
Note: A safety interval of 300 ms protects against competitive pacing and
prevents the atrial pulse from reaching refractory and/or vulnerable tissue.
This safety interval cannot be programmed and is only active when the PMT
function is active.
164 Bradycardia Therapy
Setting PMT Protection and VA Criterion
Purpose The PMT safety interval inhibits triggering of a pacemaker-mediated tachycardia
(PMT) via the algorithm on which it is based.
Description of
PMT protection
In the atrial-controlled and ventricular-controlled dual-chamber modes, the device
starts the PMT safety interval after the following events:
Ventricular pace
Premature ventricular contractions
In the ventricular-controlled dual-chamber modes, the device also starts the
PMT safety interval after the following:
Ventricular sensed events
Device parameter: PMT protection
Description of
PMT detection
The principle of PMT detection is based on the absence of a coupling between a
ventricular pace and the following atrial sensed event during sinus rhythm. When
PMT is present, there is a coupling between the Vp interval and the subsequent As
interval (which is known as the VA interval). The detection algorithm is based on the
steadiness of the VA interval length.
165 Bradycardia Therapy
Criteria for the detection
and confirmation of a PMT
A pacemaker-mediated tachycardia is recognized and confirmed by the algorithm
if the following criteria are satisfied:
Terminating the PMT The algorithm for terminating the PMT is automatically started after the PMT has
been confirmed.
Selecting device
parameters
Select Parameters Bradycardia Refractory period/Blanking to choose
the device parameters.
Setting PMT protection Proceed as follows to set PMT protection:
Criterion Description
1 The mean value of the last eight sequential Vp-As intervals
is shorter than the programmed VA criterion.
2 The mean value of the Vp-As intervals is subtracted from
each of the eight individual Vp-As intervals. The result is
compared with an internal PMT stability criterion and evalu-
ated with respect to a particular margin of fluctuation that is
tolerated. If stability exists, a confirmation phase follows.
3 If critieria 1 and 2 are met, the device automatically extends
or shortens the AV delay by a defined value. If the resulting
Vp-As interval remains constant, the PMT is considered as
confirmed.
If a low upper tracking rate and a long AV delay has been
programmed, pacing rates above the upper tracking rate
may occur for a few cycles.
Sequence Description
1 PMT protection sets the PVARP value for one cycle to the value of
the VA criterion + 50 ms.
This interrupts the retrograde conduction loop and the PMT.
Step Action
1 Select [PMT protection] to access the function.
2 Select [ON] to activate the function.
3 Open [VA criterion] and select the desired VA value.
4 Select [OK] to accept the settings. The activated PMT protection
function is accepted and displayed on the program screen.
166 Bradycardia Therapy
AV Control Window as PVC Lock-in Protection
PVC discrimination after
atrial sensed events
Pacemaker timing (programming) can cause a situation in which the device senses
ventricular events as extrasystoles that are not physiologic premature ventricular
contractions (PVC). If this takes place systematically for each cycle, then the situa-
tion is referred to as PVC lock-in.
The AV control window prevents the device from entering a PVC lock-in situation.
By starting an AV control window for each As and each As(PVARP) for example,
the device can make a distinction between real and false premature ventricular
contractions. An As(PVARP) is a refractory atrial event that occurs outside of
blanking but within the PVARP.
Distinction is made between PVC and antegrade conduction by allocating the
subsequent ventricular event (inside or outside the AV control window).
AV control window The AV control window starts in all dual-chamber modes with atrial sensing if
the following events occur:
As, As(AV), Ap, Ap(AUR), As(PVARP)
The AV control window interval is identical to the programmed AV delay
(up to 350 ms).
The AV control window is limited by the following events:
As, As(PVARP), Ap, Ap(AUR)
RVs, RVs(AVC), RVp, RVp(SW), RVp(WKB)
PI
AV
AVC
Atr. refractory period
PVARP
Far-field protection
Rate Interval
AV interval
Ven. refractory period
AV control window
A
p
A
s
(
P
V
A
R
P
)
A
s



V
p


V
s
(
A
V
C
)



V
s
180 213 265 300
153
ARP ARP ARP
PVARP
FFPp
FFPs FFPs FFPs FFPs
VA
FFB
VRP VRP VRP
AVC AVC
BI BI
AV
167 Bradycardia Therapy
Atrial Overdrive Pacing
Description Atrial overdrive pacing is used as a preventive measure to reduce the number of
atrial tachycardia incidences. Numerous clinical examinations and publications
provide information as to reducing the risk of forming atrial tachycardia. The over-
drive algorithm causes atrial overdrive pacing and ensures pacing at a rate slightly
above the intrinsic sinus rate. Atrial overdrive pacing thus minimizes the number of
sensed atrial events. Overdrive pacing is available in the modes DDD(R), DDD(R)-
ADI(R) (Vp suppression), AAI(R) and AAT(R) in the device variations DR and DR-T.
Increasing and decreasing
the rate incrementally
Each time an atrial event is sensed, the pacing rate is raised by an increase rate.
This increase rate is preset to 8 ppm and the target rate is limited by high rate
protection.
High rate protection can be set using the Maximum activity rate parameter in the
Sensor/Rate fading function (range of values 80...5...160 ppm).
If the intrinsic rate does not continue to increase (overpacing plateau), then the
overdrive rate is reduced in increments of 1 ppm. The rate decrease occurs in each
case at the end of a fixed number of 20 cycles.
The pacing rate is reduced until an atrial event is sensed again. Then the overdrive
pacing cycle starts again with rate increase.
The protective function
of the algorithm
Atrial overdrive pacing has various protective functions, which take effect at
high atrial rates:
When exceeding the programmed maximum activity rate, as is the case with
atrial tachycardia for example, the algorithm is automatically deactivated. If the
rate drops below the maximum activity rate again, then the overdrive algorithm
is activated again.
The function is also deactivated if the mean value of the atrial rate of the last
64,000 cycles exceeds the average safety rate (ASR). In this case, the pacing
rate is reduced to the basic rate incrementally. The ASR depends on the
programmed basic rate and the maximum activity rate. If the average atrial rate
drops below the ASR, then preventive overdrive pacing is activated again.
The fourth time the function is deactivated because the ASR is exceeded, overdrive
pacing is switched off permanently. Atrial overdrive pacing can only be activated
again the next time the pacemaker is interrogated.
!
!
CAUTION
When programming atrial overdrive pacing, a check should be performed to
determine whether pacemaker-mediated tachycardia can be triggered based on
the selected pacemaker program and whether atrial overdrive pacing results.
If so, it is recommended that the maximum activity rate for atrial overdrive pacing
in the Sensor/Rate fading function be programmed at a value that is lower than
the expected rate of pacemaker-mediated tachycardia.
168 Bradycardia Therapy
Setting Overdrive Pacing
Requirement for
overdrive pacing
To activate preventive overdrive pacing, you must first select a suitable pacing
mode. Proceed as follows:
Activating overdrive pacing Proceed as follows:
The following 3 parameters control the function. The first two are preset and
cannot be changed:
Rate increase
Rate decrease
Max. overdrive rate
The Maximum overdrive rate parameter can be configured by changing the
maximum activity rate in the Sensor/Rate fading function.
Sequence
Step Action
1 Open Parameters Bradycardia and [Mode].
The corresponding window is opened.
2 Select one of the possible pacing modes for atrial overdrive:
DDD(R)
AAI(R)
AAT(R)
DDD(R)-ADI(R)
The function can now be activated. If no suitable pacing mode has
been selected for atrial overdrive pacing, then the function cannot be
activated.
Step Action
1 Select [Atrial overdrive] and [ON] to activate the function.
Sequence Description
1 After each sensed atrial event (except for sensed PAC), the pacing
rate is increased.
2 The amount of this increase is controlled by the Rate increase
parameter.
3 If the spontaneous rate drops again, then the pacing rate is
reduced incrementally with a set number of cycles.
4 The rate decrease occurs in each case after completion of the
set cycles until an atrial event is sensed again.
169 Bradycardia Therapy
5.7 Patient Data and Diagnostics/HM Tabs
What's in this section? This section contains the following topics:
Topic Page
Parameters: Patient Tab 170
Parameters: Home Monitoring/Diagnostics Tab 171
170 Bradycardia Therapy
Parameters: Patient Tab
Purpose The information on this tab is used for patient identification and the allocation of
follow-up data sets stored in the ICS 3000 programmer.
It includes the following details:
During implantation: entry of patient data for storage in the device.
During follow-up: check the patient data interrogated by the device, correct if
necessary, and print out the report.
User interface Patient tab:
The following fields can be filled out:
Patient data:
Patient ID, first name, last name, date of birth, gender
Implantation data:
Date of implantation, hospital, physician, LVEF, NYHA
Anamnesis data:
Symptom, ECG indication, etiology
Lead data (atrium and ventricle):
Polarity, type, manufacturer, lead position in each case
Entering patient data
and transmitting them
to the device
Proceed as follows:
1 Select Parameters Patient.
2 Make entries in the input fields.
3 Checkmark the appropriate facts in the anamnesis lists.
4 [Program]
The entered data are sent to the device and saved in the follow-up
history.
Note: The follow-up history is found in the Follow-up Last follow-up group
box.
171 Bradycardia Therapy
Parameters: Home Monitoring/Diagnostics Tab
Purpose The following parameters can be set in the [Home Monitoring/Diagnostics] tab:
Events and settings that trigger IEGM (Holter) recording
Settings for data transfer via Home Monitoring
Calling the tab Proceed as follows:
User interface Parameters for diagnostics and Home Monitoring:
1 Select Parameters Home Monitoring/Diagnostics.
Note:
Home Monitoring is only available in devices with the T function.
172 Bradycardia Therapy
Home Monitoring The parameters in detail:
Parameter Description
HM PID Display: Product identification number
This is required for registration of the patient with the
Home Monitoring Service Center (found on the status
page of the programmer or on included labels).
Home Monitoring Setting: ON; OFF
Default setting: OFF
Time of
transmission
Setting: Time for transmitting the device message
to the patient device; Auto (between 1:00 and
2:00 a.m.)
Default setting: AUTO
Periodic IEGM
[days]
Setting: Interval between two scheduled messages,
which contain an IEGM: 30, 60, 90, 120, 180 days
Default setting: 30 days
High atrial rate Controls sending of messages at high atrial rates
(HAR). Values are adopted from the Holter setting.
An IEGM is not sent via Home Monitoring.
Setting: Automatically adopted from Holter trigger
and High atrial rate (HAR), see below.
Ongoing
atr.episode
[hh:mm]
Setting: Time with which an atrial episode is defined
as sustained. If the set duration is exceeded, then
the next device message provides information
pertaining to the occurrence of this episode.
Values: 6; 12; 18 hours
High ventricular
rate
Controls sending of messages at high ventricular
rates (HVR). Values are adopted from the Holter
setting. An IEGM is not sent via Home Monitoring.
Setting: Automatically adopted from Holter trigger
and High ventricular rate (HVR), see below.
CardioMessenger Activation: Activation of the CM (CardioMessenger)
tab for fixed allocation of implanted device and a
specific patient device
Message type Display: Trend message; event message; test
message
Message created on Display: Time of transmission of the message
transmitted last, day and time
[Send test message]
button
Button used to trigger sending of a test message
from the implanted device to the patient device.
The programming head has to be removed from the
device for 10 seconds.
173 Bradycardia Therapy
Holter triggers You set the parameters for the Holter recording in the following group boxes.
High atrial rate (HAR)
High ventricular rate (HVR)
Parameter Description
High atrial rate Select whether exceeding a detected atrial rate
should trigger an IEGM recording.
Values:
Off
ModeSw - triggered on exceeding the upper rate
for mode switching.
AT - atrial tachycardia - triggered on exceeding
the rate specified under HAR limit.
High ventricular
rate
Select whether exceeding a detected ventricular rate
should trigger IEGM recording.
Values: OFF; ON
Patient trigger Select whether the patient should be able to trigger
Holter recording by applying a magnet.
If you activate this option, then the magnet effect will
be automatically set to synchronous for safety
reasons.
Values: OFF; ON
Please instruct your patient.
Pre-trigger
recording [%]
Specify here the portion of the entire recording time
(10 sec.) which is before the trigger event.
Values [%]: 0; 25; 50; 75; 100
IEGM signal Filtered or unfiltered
Parameter Description
HAR limit [bpm] Enter the atrial rate limit (100 ... 250 bpm) that
triggers an IEGM recording if it is exceeded.
Parameter Description
HVR limit [bpm] Enter the ventricular rate limit (100 ... 200 bpm) that
triggers an IEGM recording if it is exceeded.
HVR counter
[Events]
Maximum number of recorded events.
Values: 4; 8; 12; 16
174
6 Home Monitoring
Home Monitoring 6365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Introduction 175
Home Monitoring Parameters 176
Types of Device Messages 177
Criteria for the Use of Home Monitoring 178
Periodic IEGM 179
175 Home Monitoring
Introduction
About the Home Monitoring
function
With BIOTRONIK's Home Monitoring function, patients can be treated even more
effectively. All Home Monitoring devices are equipped with a small transmitter and
are designated with the letter 'T' (e.g., DR-T, SR-T).
All functions and features of the basic device, such as pacing and sensing
functions, preset parameters, or memory functions, are unaffected by the
Home Monitoring function.
With Home Monitoring, you can view the data transmitted by the device in a clear
form in the Internet and thus always be informed of your patient's cardiac status.
A patient device receives messages from the device and transmits them to the
BIOTRONIK Service Center. At the Center, the data are processed and are made
available via a secure Internet connection.
The devices Home Monitoring function can be used for the entire service life of
the device or for shorter periods, such as several weeks or months.
The most important components of Home Monitoring are the implanted device,
the patient device, and the Internet platform Home Monitoring Service Center.
Device The power of the device's transmitter is very low, so that the patient's health is not
affected in any way. The resulting small transmission range requires the use of a
special transmitter to forward the device data to the BIOTRONIK Service Center.
The patient's device data are sent to the transmitter once a day (usually at night).
With Home Monitoring, the distance between the device and the transmitter should
not be less than 20 centimeters (6 inches) and not more than two meters (6 feet).
Transmitter The transmitter collects the data sent by the device and transmits the information
via the cellular phone network to the BIOTRONIK Service Center.
The stationary transmitter (e.g. CardioMessenger II-S) is usually placed on the
patient's bedside table. The patient can take it on trips and also set it up and
connect it to the power supply while on vacation.
BIOTRONIK
Home Monitoring
Service Center
The BIOTRONIK Service Center receives the data sent by the transmitter and
evaluates them. The analysis criteria are specific to the particular device and can
additionally be individually customized for each patient. The results of the analysis
are presented both in diagram and table form on the secure Internet platform.
If the value of a transmitted parameter is outside the defined limits, a monitoring
finding is created if the system is configured to do so. Monitoring findings can
automatically trigger notifications that are sent to the attending physician via fax,
SMS or E-mail.
The BIOTRONIK Home Monitoring Service Center is the Internet platform where
patients' current monitoring findings are presented clearly and accessibly. The
Detail view contains specifics about monitoring findings and medical histories for
every patient.
Programmer You have to set the Home Monitoring function in the programmer and register the
patient in the Home Monitoring Service Center.
For information about activating Home Monitoring on the programmer, see the
manual for the programmer.
For information about registering as a user in the Home Monitoring Service Center,
see the technical manual for the Home Monitoring Service Center.
For information on registering a new patient in the Home Monitoring Service
Center, refer to the online help of the Home Monitoring Service Center.
176 Home Monitoring
Home Monitoring concept
Home Monitoring Parameters
Home Monitoring OFF, ON
You can activate or deactivate the Home Monitoring function using the program-
ming device. The additional sub-functions can only be used if Home Monitoring
has been activated. When the function is switched on, all other parameters are
automatically reset to the default settings.
Time of transmission AUTO, 0:00...23:50 h
Set a time between 0:00 and 23:30 for the device message. It is recommended to set
a time between 0:00 and 4:00 when the patient is usually sleeping.
The default time of transmission [AUTO] is a time of transmission between 1 and
2 o'clock.
Periodic IEGM 30, 60, 90,180 days
Configure the interval for generating and transmitting the periodic IEGM. You can
find further information pertaining to periodic IEGM in the section Periodic IEGM,
p. 179 .
Ongoing atrial episode 6, 12, 18 hours
Set the minimum duration here, which an atrial episode has to have to be evaluated
as a persistent atrial episode. Device messages which indicate a persistent atrial
episode are transmitted to the Home Monitoring Service Center more quickly in
some cases.
!
CardioMessenger
Patient
Data transmission
Home Monitoring
Service Center
Physician
sbiotronik
177 Home Monitoring
Types of Device Messages
Types of device messages Devices with the Home Monitoring function send the device message daily at a
specified time. The device message can contain varying amounts of data:
Each message contains the results of daily measurements and statistics.
The first message after implantation and every message after reprogramming
(e.g., as part of follow-up) also contain all information on the current device
settings.
The periodic IEGM message also contains the current device settings and the
periodic IEGM.
Depending on the transmitter used, these data are passed on immediately or, if the
data is normal, it is collected for up to 2 weeks. Device messages, which indicate
certain events in the patient's heart or in the device, are forwarded immediately.
Test message A test message can be triggered with the programmer to test the connection to the
Home Monitoring Service Center. The test message is sent immediately. If it is
received by a transmitter, then it immediately forwards the test message to the
BIOTRONIK Service Center.
You can view the test message just a little later on the protected Internet platform,
if data has been entered for the patient. Therefore you should make sure the data
for the patient has been entered in the Home Monitoring Service Center before
sending the test message.
Event message When the device detects certain cardiac and technical events, an event message is
sent to the patient device. The triggering events are adjusted to the specific device.
You can go to the Home Monitoring Service Center on the Internet and configure
whether you also want to receive event reports for these events.
A range of events, e.g., when the battery reaches ERI, can never be deselected. For
more information about events, consult the online help for the Home Monitoring
Service Center.
178 Home Monitoring
Criteria for the Use of Home Monitoring
Purpose The general medical objective is to make diagnostic information available to physi-
cians. The therapeutic effect of devices that transmit data is not affected because
the Home Monitoring Service Center has no direct effect on the device.
For a detailed description of the objective of the Home Monitoring system, see
the manual for the Home Monitoring Service Center.
Prerequisites The technical specifications and system requirements for access to the Home
Monitoring Service Center are included in the manual of the Home Monitoring
Service Center.
Indications and
contraindications
The recognized indications and contraindications for pacemakers and ICDs are
applicable and are independent of Home Monitoring. There is no absolute indica-
tion for the use of the Home Monitoring Service Center.
There are no contraindications for the use of the Home Monitoring Service Center
as a diagnostic tool because it has no effect on the diagnostic or therapeutic
functionality of the device. However, proper use of Home Monitoring requires the
complete cooperation of the patient. Moreover, the physician must have access to
the Home Monitoring data (per fax and/or Internet) in order to be able to use the
Home Monitoring Service Center.
Warnings and precautions Recognized warnings and precautions for pacemakers and ICDs are applicable
and are independent of Home Monitoring. However, there are other specific
precautions for Home Monitoring as well.
Please note the specific warnings and precautions for Home Monitoring in the
manual of the BIOTRONIK Home Monitoring Service and in the manual of the
patient device.
Home Monitoring
scope of functions
Monitoring of system integrity:
Battery status
Monitoring of lead integrity:
Impedance in the atrium and ventricle
Pacing thresholds in the atrium and ventricle
Sensing amplitudes in the atrium and ventricle
Bradycardia and tachycardia rhythm and therapy monitoring:
Sensing/pacing counters
Detected episodes
Patient activity
Heart rate
179 Home Monitoring
Periodic IEGM
The device can record an IEGM in a time-controlled manner at regular intervals and
transmit this together with the daily device message. Thus the attending physician
can gain comprehensive insight into the patient's cardiovascular condition without
having the patient come in for follow-up.
The periodic IEGM is deleted following transmission. Therefore it can only be
viewed in the Home Monitoring Service Center and not with the programmer.
Depending on the device type, the IEGM sent by Home Monitoring consists of
the following:
Right atrial marker channel
Right ventricular marker channel
Right atrial morphology
Right ventricular morphology
The IEGM is subdivided into 3 recorded sequences of at least 10 seconds duration:
Normal
Recording with the current device settings
Forced sensing
Modes: AAI(R), VVI(R), VVI-CLS, DDD(R), DDD-CLS, VDD(R)
Recording with programmed AV hysteresis and rate hysteresis
If the hystereses are switched off, the adjusted AV delay + 70 ms is effective.
Basic rate -10 ppm ones, if the rate is > 40 ppm
Basic rate -5 ppm if the rate is 35 - 40 ppm
No rate change if the rate is < 35 ppm
Forced pacing
Modes: AAI(R), VVI(R), VVI-CLS, DDD(R), DDD-CLS, VDD(R)
In the modes DDD(R), DDD-CLS and VDD(R), increase of the atrial rate
by 12.5% with an AV delay of 100 ms
In the modes AAI(R), increase of the atrial rate by 12.5%
In the modes VVI(R) und VVI-CLS, increase of the ventricular pacing rate
by 12.5%
Note: Average rate determined during intrinsic IEGM registration; rate increase
limited by the upper rate; no forced sensing and no forced pacing in the DDI mode
180 Home Monitoring
IEGM types and
marker channel
The following diagrams are excerpts. At least 10 seconds of each IEGM type are
recorded and sent.
IEGM type: Normal
IEGM type: Forced sensing
IEGM type: Forced pacing
181
7 Evaluating Holter Data
Evaluating Holter Data7365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Displaying IEGM Recordings (Holter) 182
182 Evaluating Holter Data
Displaying IEGM Recordings (Holter)
Showing the graphic display
of an IEGM recording
Proceed as follows:
Interrogating all data sets If you interrogate all data sets, then all IEGM recordings can be displayed on the
ICS 3000 screen without delay.
The following procedures are triggered with the [Interrogate] button:
All data sets from the Holter memory of the device are transmitted to the
ICS 3000.
The duration of this procedure depends on the scope of the data:
The real-time IEGM is not available during this time. The status bar shows:
Interrogation....
After all data records have been transmitted, the status bar contains the
message Interrogation was successful.
Defining criteria and
parameters for the
Holter function
Use the link Set arrhythmia detection parameters to display the
Home Monitoring/Diagnostics tab in the Parameters window. The criteria
and parameters for the device's Holter function can be defined in the Holter
triggers group box here. See: Parameters: Home Monitoring/Diagnostics Tab,
p. 171.
Displaying, evaluating,
saving, and printing the
Holter IEGM
Proceed as follows to display a recorded IEGM with the programmer from the list
of the Holter data:
Step Action Result
1 Select [Holter]. The respective window is opened and
displays the saved types of IEGM
recordings.
2 Select the desired IEGM
recording from the
displayed list by
clicking on it.
After selecting the desired IEGM
recording from the list, the device is
interrogated. The data are read from
the device and displayed in the
associated window as a graph.
Step Action
1 Click on the IEGM symbol of the desired recording in the View
column.
The programmer opens an IEGM display window with an expres-
sive signal display, comprehensive remarks, options for adapting
the display, and buttons for printing and saving.
2 The Evaluating, Interpreting and Storing ECG/IEGM Data section
of the Handling basics chapter provides information on how to
adapt the IEGM display as well as print and save the IEGM.
183
8 Statistics
Statistics8365350-AEvia Function Manual
What's in this chapter? This chapter contains the following sections:
Section Topic Page
8.1 Statistics General 184
8.2 Evaluating Statistics 187
184 Statistics
8.1 Statistics General
What's in this section? This section contains the following topics:
Purpose The statistical evaluation can help optimize diagnostics and therapy.
Description The diagnostic data stored in the device can be transmitted to the programmer.
The diagnostic memory functions of an device are grouped according to content
aspects and allocated to specific statistics. These statistics are displayed as tabs on
the programmer. The following statistics can be evaluated:
Timing of the device
Atrial arrhythmia
Ventricular arrhythmia
Sensor
Sensing
Pacing
Displaying the statistics The content of the diagnostic memory is displayed as follows:
Event counters...
are usually displayed as bar charts with a percentage indication and an entry of
the total events.
Histograms...
count the frequency of events in various time or rate intervals.
Trends...
represent a certain number of events at a fixed point in time (e.g. rates).
The trends consist of points that are joined together as a curve.
Interrogating the statistics During the first interrogation of a device, all statistical data is automatically
retrieved from the device list (when all data is interrogated), transmitted to the
programmer and then stored there. This allows you to call up the statistical data via
the programmer at any time.
Interrupting the recording
of diagnostic data
The following events interrupt the recording of diagnostic data:
ERI
Magnet or programming head application
Topic Page
Selecting Statistics 185
185 Statistics
Selecting Statistics
Overview The following actions can be performed with the Statistics function:
Interrogate statistics
Display statistics
Select statistics
Evaluate statistics
Delete statistics (restart)
Interrogating statistics During the first interrogation of a device, all statistical data is automatically
retrieved from the device list (when all data is interrogated), transmitted to the
programmer and then stored there.
Displaying statistics Once the Statistics function is called up, the Timing statistics are opened. Its first
tab, Event counters, is automatically displayed with the corresponding graph.
Selecting statistics Proceed as follows to select the statistics:
Example: Event counters
Step Action Result
1 Select [Statistics] to initiate the
function.
The various statistics are
displayed as tabs.
2 Select the required statistics on
the tab (e.g. [Timing]).
The associated statistics func-
tions are displayed as buttons on
the right side of the screen.
3 Select one of the buttons, e.g.
[Event counters].
The respective graph of event
counters is displayed.
4 Switch between the individual
statistics functions by pressing
the buttons on the right side of
the screen.
The corresponding data is
displayed.
186 Statistics
Evaluating statistics Proceed as follows to evaluate the statistics:
Updating statistics The statistical data is updated when it is reinterrogated. This requires that the
device is interrogated again from the device list. During this, the displayed current
device values overwrite the previously displayed data.
Delete/restart statistics Proceed as follows:
Step Action
1 Select [Print] and begin evaluating the data. As an alternative, you
can analyze the data directly on the screen.
Step Action
1 Select [Interrogate statistics]. The updated data is displayed.
Step Action
1 Select [Restart] to reset all counters of the statistics to zero.
All existing statistics in the device are deleted if you confirm the
software security prompt.
Note: Each time the parameters of the permanent program are changed, the
memory contents are deleted and the statistics are restarted.
187 Statistics
8.2 Evaluating Statistics
What's in this section? This section contains the following topics:
Topic Page
Displaying Timing Statistics 188
Displaying Arrhythmia Statistics 190
Displaying Sensor Statistics 191
Displaying Sensing Statistics 192
Displaying Pacing Statistics 193
188 Statistics
Displaying Timing Statistics
Overview The following timing statistics are available:
Event counters
Event episodes
24-hour rate trend
240-day rate trend
Rate histograms
Description
The individual timing statistics are described briefly in the following:
Note: Premature ventricular contractions are counted both as PVC as well as
ventricular sensed events.
Classification Description
Event counters The event counters are divided into two groups:
Atrial sensing (As) and atrial pacing (Ap):
As: Atrial sensing outside the atrial refractory period
As (PVARP): Atrial sensing within the PVARP refractory period
Ars: Sensing in the refractory period of the atrium
Ap: Atrial pacing
Ventricular sensing (Vs) and ventricular pacing (Vp):
Vs: Ventricular sensing outside the ventricular refractory period
PVC: Premature ventricular contraction
Vrs: Sensing in the refractory period of the ventricle
Vp: Ventricular pacing
Event counters can record events for a period of up to 240 days. Older recordings
will be overwritten continuously.
Event episodes Event episodes add up the events in the atrium and ventricle to display them in a
bar chart with percentage distribution information. Sensed and paced events are
taken into account:
As - Vs: Atrial sensing (As) and ventricular sensing (Vs)
As - Vp: Atrial sensing (As) and ventricular pacing (Vp)
Ap - Vs: Atrial pacing (Ap) and ventricular sensing (Vs)
Ap - Vp: Atrial pacing (Ap) and ventricular pacing (Vp)
Vx - Vx: V followed by V are two consecutive ventricular events (Vs, Vp or PVC)
without previous atrial event.
24-hour rate trend The 24-hour rate trend for dual-chamber devices is divided into two groups.
The ventricular curve is displayed as a thicker line and the atrial curve is
displayed as a thinner line:
Rate in ppm:
No automatically compressed trends are recorded. One recording point
per hour is stored. After 24 hours the recording is rolling.
Pacing as percentage:
Pacing rate trend with indication of the percentage distribution
189 Statistics
240-day rate trend The 240-day rate trend for dual-chamber devices is divided into two groups.
The ventricular curve is displayed as a thicker line and the atrial curve is
displayed as a thinner line:
Rate in ppm:
Details: One recording point per day is stored in each case. After 240 days,
the recording is rolling.
Pacing as percentage:
Pacing rate trend with indication of the percentage distribution
Rate histograms In dual-chamber devices, a separate atrial and ventricular rate histogram is
recorded, which is displayed as a bar chart with percentage indication of the
heart rate as well as the absolute value. The number of times a heart rate occurs
within certain rate ranges is recorded separately according to sensing and
pacing. A marker also displays the max. activity rate.
Classification Description
190 Statistics
Displaying Arrhythmia Statistics
Overview The individual arrhythmia statistics and the criteria for assignment to a classifica-
tion are described in the following:
Atrial arrhythmia statistics
Atrial burden
Time distribution
Mode switching
Ventricular arrhythmia statistics
PVC sequences
Atrial arrhythmia statistics
Ventricular arrhythmia
statistics
Classification Description
Atrial burden This function registers the number and duration of atrial
tachycardia. The sum and duration of the atrial tachycardia
that have occurred are displayed for each day as a peak in
the [Episodes] and [Duration] charts. Place the cursor on a
peak using the arrow key to display the quantity and
duration values above the graphic.
Set the tracking rate for the beginning of recording of the
atrial arrhythmia by selecting [Set arrhythmia detection
parameters]. The HAR limit [bpm] can be specified in the
High atrial rate (HAR) group box.
Time distribution This function adds up all recorded atrial tachycardia sorted
according to time of occurrence over the course of 24 hours.
A bar chart displays the average time distribution over the
course of 24 hours as a percentage.
Mode switching The following recordings and parameters are displayed:
Mode switching events [quantity]
Duration of mode switching [dd, hh:mm]
Intervention rate [ppm]
Classification Description
PVC sequences This function permits long-term recording and classifica-
tion of premature ventricular contractions (PVC). They are
categorized in five groups based on frequency of occur-
rence. These are expressed as percentages in a bar chart.
The following PVC types are recorded and displayed:
Single PVC
Couplets
Triplets
Runs (4 ... 8)
Runs (> 8)
Additionally, the number of high ventricular rates (HVR) is
recorded and displayed:
HVR episodes [quantity]
191 Statistics
Displaying Sensor Statistics
Description The sensor in the device can measure physical activity and adjust the heart rate
adequately.
The following sensor statistics are recorded:
Sensor histogram
Activity report
The recording of the sensor rate does not depend on whether the respective pacing
rate was effective or whether intrinsic events were in the foreground.
Selecting statistics Proceed as follows to display the sensor statistics:
Sensor statistics The device records the following sensor statistics:
Note: The sensor histogram and the activity report are also recorded and
displayed if no rate-adaptive pacing mode has been set.
Step Action
1 Select [Sensor].
2 Select one of the displayed sensor statistics (e.g. [Sensor
histogram]). The corresponding graph is displayed in the window.
3 Evaluate the data.
Type Description
Sensor histo-
gram
The frequency with which the sensor rate occurs in certain rate
ranges is recorded. The rate range is divided into 16 equidistant
rate ranges between < 40 to > 180 ppm. The sensor histogram
displays the percentages of the individual rate ranges in the
form of a bar chart and the total number of recorded days since
the beginning of recording.
Activity report The time evaluated by the sensor of the device as physical
activity is shown in the chart as activity. A percentage indication
and a symbol are displayed for the following criteria:
Max. sensor rate
Activity
No activity
192 Statistics
Displaying Sensing Statistics
Description The sensing functions of the device are displayed in the sensing statistics:
Selecting statistics Proceed as follows to select the sensing statistics:
Type Description
P/R wave trend The P/R wave trend displays the development of the signal
sensed in the atrium and ventricle as a two-colored line
chart. The P/R wave trend records values ranging from
0.0 to 40 mV. Daily values are shown above the diagram if
the cursor is placed over the date.
Far-field
histogram
The far-field histogram displays the events which are evalu-
ated as far-field sensing by the device (gray area). The histo-
gram also records atrial sensed events which are outside
the far-field window.
As-Vs interval
distribution
This diagram displays the programmed AV delay as well as
the distribution of the As/Vs intervals. A counter documents
how often the AV scan hysteresis has been successful.
Ap-Vs interval
distribution
This diagram displays the programmed AV delay as well as
the distribution of the Ap/Vs intervals. A counter documents
how often the AV scan hysteresis has been successful.
Ven. pacing
suppression
This diagram shows the duration as a percentage for a day
in which the system works with the ADI(R) functionality due
to ventricular pacing suppression. Daily values are shown
above the diagram if the cursor is placed over the date.
The total sum and the Vs scan count after ventricular pacing
suppressions are displayed above the diagram.
Step Action
1 Select [Sensing].
2 Select one of the displayed sensing statistics (e.g. P/R wave
trend). The corresponding sensing graph is displayed in the
window.
3 Evaluate the data.
193 Statistics
Displaying Pacing Statistics
Overview The following pacing statistics are available:
Lead impedance trend
Pulse amplitudes and threshold trend
Pulse amplitudes histogram
Capture control status
Description
The individual pacing statistics are described briefly in the following:
Selecting statistics Proceed as follows to select the pacing statistics:
Note: In the lead impedance trend and pulse amplitude/threshold trend windows,
the Y axis is scaled according to the respective maximum measured value.
Classification Explanation
Lead impedance
trend
The lead impedance trend function stores the automatically
measured impedances for atrial and ventricular leads on a
daily basis. The diagram displays this as a trend. The
measured value range is between 0 and 2500 Ohms.
Pulse amplitude /
threshold trend
The pulse amplitudes and threshold trend function stores
the paced pulse amplitudes and automatically measured
pacing thresholds for atrium and ventricle on a daily basis.
The diagram displays this as a trend. The measured value
range is between 0 and 5 Volts.
Pulse ampl.
histogram
The pulse amplitude histogram records the number and the
percentage of the paced pulse amplitudes in combination
with the capture control function. The measured value range
is between 0 and 7 Volts.
Capture control
status
This status function provides information pertaining to
right-atrial and right-ventricular capture control:
Status
Note
Pacing threshold
Date and time
The capture control function has to be activated to record
threshold values.
Step Action
1 Select [Pacing].
2 Evaluate the data.
194
9 System Functions of the Device
System Functions of the Device9365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Reading out Device Data 195
195 System Functions of the Device
Reading out Device Data
Purpose To be able to export data from an implanted device to an external data medium, the
data must first be read from the device using this function.
Reading data To apply this function, proceed as follows:
Step Action
1 Select [More] and click on the tab with the name of the device.
2 Select the [Memory dump] button in the Transfer memory
contents group box.
The data are read out via device interrogation. The duration of the
interrogation is displayed as a percentage. When the data have
been read successfully, the system indicates in the status bar:
Interrogation was successful
3 Proceed as described in the technical manual Handling Basics.
196
III Follow-up
Follow-upIII365350-AEvia Function Manual
What's in this part? This part contains the following chapters:
See part III of the function manual for further information on all topics related to
follow-up.
Chapter Chapter name Page
10 Performing Automatic Follow-Up 197
11 Archive - Events - Measured Value Trends 204
12 Performing Manual Follow-up 210
197
10 Performing Automatic Follow-Up
Performing Automatic Follow-Up10365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
The follow-up concept
at a glance
The follow-up is virtually fully automated because all relevant data is measured
periodically.
When the device is interrogated, the measurement data including pacing threshold,
P/R amplitude and lead impedance, for example, are available because they are
saved periodically.
Therefore, it will not be necessary to carry out additional manual measurements in
many cases.
In addition to the saved measurement data, which indicate automatically measured
values with two white arrows, all important data for medical evaluation are
displayed at a glance.
Hyperlinks, which are indicated in bold lettering, lead to more menus and serve to
make navigation very convenient.
If required, follow-up tests can be started right from this page for manual imple-
mentation. A real-time IEGM is displayed with all relevant markers when the
programmming head is applied.
Other convenient functions on the follow-up page are:
Follow-up history of the 10 most recent follow-ups can be accessed directly
Patient and implantation data
Device status with the most important permanent program parameters
Error messages and episodes
Archive of the measurement trend and Holter recordings, diagnostics data
(statistics)
Battery status and replacement indication
Topic Page
Follow-up 198
The Follow-up Window 199
Real-time IEGM on the Software Interface 201
Configuring and Performing Automatic Follow-up 202
198 Performing Automatic Follow-Up
Follow-up
Follow-up intervals Follow-ups must be performed at regular, agreed intervals.
Following the lead ingrowth phase, approximately 3 months after implantation,
the first follow-up should be carried out by the physician using the programmer
(in-office follow-up).
The next in-office follow-up should be carried out once a year and no later
than 12 months after the last in-office follow-up.
Follow-up with
BIOTRONIK Home
Monitoring

Monitoring using the Home Monitoring function does not serve to replace regular
in-office appointments with the physician required for other medical reasons.
Follow-up supported by Home Monitoring can be used to functionally replace
in-office follow-up under the following conditions:
The patient was informed that the physician must be contacted if symptoms
worsen or if new symptoms arise despite of the use of the Home Monitoring
function.
Device messages are transmitted regularly.
The physician decides whether the data transmitted via Home Monitoring with
regard to the patient's clinical condition as well as the technical state of the
device system are sufficient. If not, an in-office follow-up has to be carried out.
Possible early detection due to information gained via Home Monitoring may
necessitate an additional in-office follow-up. For example, the data may indicate at
an early stage lead problems or a foreseeable end of service time (ERI). Further-
more the data could provide indications of previously unrecognized arrhythmias or
modification of the therapy by reprogramming the device.
Follow-up with
the programmer
Use the following procedure for in-house follow-up:
1 Record and evaluate the external ECG.
2 Check the sensing and pacing function.
3 Interrogate the device.
4 Evaluate the status and automatically measured follow-up data.
5 Possibly evaluate statistics and Holter/IEGM recording.
6 Manually perform standard tests if necessary.
7 Possibly customize program functions and parameters.
8 Transmit the program permanently to the device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.
199 Performing Automatic Follow-Up
The Follow-up Window
Displaying the follow-up
window automatically
If the ICS 3000 has been started and the programming head is placed over the
device, then the device is interrogated automatically and the Follow-up window is
displayed.
Manually displaying the
follow-up window
To access the follow-up function from a different function of the program, proceed
as follows:
Handling concept Display the individual functions immediately by clicking on a parameter within the
group boxes. Parameters in the Test results group box and those displayed in
bold font are interactive. The Device status and Diagnostics group boxes
only provide information and are not interactive.
Meaning of the arrows
beside the measured values
White double arrows beside measured values or parameters mean that these
values have been measured or set automatically.
User interface The program window for automated follow-up is shown below:
The follow-up window is divided into five sections:
In the Patient group box, you will find the patient name, the Date of
implant and, under Last follow-up, the follow-up history.
In the Device status group box, you will see an overview of the most
important active pacing parameters such as Mode, Basic rate/UTR [ppm],
Pulse amplitude [V], and Pulse width [ms]. Under Expected ERI,
you can find information on the expected service life until ERI as well as a bar
showing the battery status.
Notes on special events stored in the Holter with the corresponding IEGMs can
be found in the Alerts and episodes group box.
For details on this, see: Event List, p. 205
Step Action
1 Select [Follow-up] from the bar on the right side.
200 Performing Automatic Follow-Up
In the Test results group box, you will find the display of measured values
for tests which have been measured automatically or manually.
Press the [TrendView] button to display an overview of the measured value
trends since the most recent follow-up. For further details, see:TrendView -
Overview of Important Measured Value Trends of the Device, p. 207
In the Diagnostics group box you will find an important excerpt of the data
stored in the Statistics function such as Pacing in A/V [%] and Atrial
burden [%]. For further details, see: Evaluating Statistics, p. 187
Performing the
follow-up test
Press the [Start tests] button to perform an automatic follow-up procedure.
You can individually call up and perform any test by clicking on the test name:
P/R wave amplitude [mV].
Capture threshold [V].
Lead impedance [Ohms]; is performed on an ongoing basis and cannot be
performed manually.
Displaying the
follow-up history
In the Patient group box, you can call a list of stored data sets for follow-up
procedures that have already been performed by clicking on Last follow-up.
For more information on this, see: Archiving Follow-up Results, p. 206
201 Performing Automatic Follow-Up
Real-time IEGM on the Software Interface
Real-time ECG/IEGM
display
While the magnet is being applied, a real-time IEGM of the data transferred from
the device is displayed on the programmer screen.
The IEGM is produced simultaneously for the relevant channels with a scan rate of
256 Hz.
At the same time a marker channel and a surface ECG channel are displayed.
Availability and temporary
exceptions
This real-time monitoring of the current IEGM data is constantly available during
the follow-up. The only times the IEGM is not updated is during initial interrogation
of the device and during transmission of Holter and statistics data.
Further information Detailed explanations of IEGM display adaptation and handling of the
programmer's recording function are available in the technical manual - handling
basics.
Real-time IEGM
during tests
The following measured values are displayed in the real-time IEGM window while
the various tests are being conducted:
During the sensing test: the amplitudes of the sensed signals
During the threshold test: the pulse amplitudes
During the retrograde conduction test: the conduction times
Recording the IEGM The [Freeze] button can be used to have the software display a snapshot of the
IEGM in another window. Detailed markers and entries of measured values are
displayed in this window.
Marker overview The following marker symbols and labels are displayed in the real-time IEGM
window and in the Freeze window.
Channel Display in the IEGM marker
channel
Display in the
Freeze window
Event, meaning
Atrium Marker up, long, label: P Marker up, label: Ap Atrial pace
Atrium Marker up, short, label: S Marker up, label: As Atrial sensing
Atrium Marker up, very short, no label Marker up,
label: Ars (PVARP)
Atrial sensing during PVARP
Atrium Marker up, very short, no label Marker up,
label: Ars
Atrial sensing of a refractory or inter-
ference signal
Atrium Marker up, very short, no label Marker up,
label: Ars (FFP)
Atrial refractory sensing during the
period of far-field protection
Ventricle Marker down, long, label: P Marker down,
label: Vp
Ventricular pacing, ventricular triggered
pacing, pacing in the ventricular safety
window, ventricular pace after UTI
(Wenckebach), ventricular backup pace
Ventricle Marker down, short, label: S Marker down,
label: Vs
Ventricular sensing, ventricular sensing
in AV control interval
Ventricle Marker down, very short,
no label
Marker down,
label: Vrs
Ventricular sensing of a refractory or
interference signal
Ventricle Marker down, short, label: S Marker down,
label: VES
Premature ventricular contraction
202 Performing Automatic Follow-Up
Configuring and Performing Automatic Follow-up
Automatic functions
at a glance
Follow-ups for the devices are largely automated. As soon as interrogation is
performed for the follow-up, measured value data are available in the Test results
group box for the following tests:
P/R wave amplitude [mV]
Capture threshold [V]
Lead impedance [Ohms]
The pacing threshold test is automatically performed at specific times of day or
at hourly intervals if the Capture control has been set to ON or ATM in the
Parameters window.
Prerequisites The following requirements must be met for an automatic follow-up procedure:
Telemetry contact between the device and the programmer has been estab-
lished.
The device can be interrogated automatically.
The programmer confirms the process with the following message in the status
bar:
Interrogation was successful
There is enough printer paper in the programmer printer tray (if printing is to
be carried out with the ICS 3000).
!
!
WARNING
Patient endangered by interrupted telemetry!
Communication error between the programming head and the device during
the pacing threshold test or the P/R amplitude measurement may result in
inadequate pacing.
The permanent program can be activated immediately at any time by removing
the programming head from the device.
203 Performing Automatic Follow-Up
Repeating the
automatic tests
You can repeat the tests at any time if the measured values do not seem plausible.
Results of the
automatic follow-up tests
The results of the automatic follow-up can be found as follows:
An overview of the follow-up test results can be found in the Test results
group box in the Follow-up window.
During follow-up, the automatic test functions generate an IEGM display
with test markers in real-time and a print file with a short IEGM sequence.
This short IEGM sequence can be displayed and printed with the set parameters
via More Print manager Preview.
The follow-up results are electronically archived:
The archived follow-up results can be displayed by clicking on Last follow-
up in the Patient group box. See: Archiving Follow-up Results, p. 206
Canceling the
automatic follow-up
To cancel an automated follow-up, select [Stop].
Step Action Comments
1 Select [Start tests].
2 The P/R wave amplitude
[mV] is determined
The IEGM is displayed in real-
time. P and R amplitudes are
displayed with markers
3 The Capture threshold
[V] is determined
The IEGM of the pacing
threshold test is transferred in
real-time.
4 The Lead impedance
[Ohms] is measured.
The lead impedance is always
measured automatically and
continuously by the device.
204
11 Archive - Events -
Measured Value Trends
Archive - Events - Measured Value Trends11365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Event List 205
Archiving Follow-up Results 206
TrendView - Overview of Important Measured Value Trends of
the Device
207
205 Archive - Events - Measured Value Trends
Event List
Description Specific cardiac events are stored in the device. These provide information for
assessing the status of the patient and device and for optimizing follow-up.
The Alerts and episodes group box in the Follow-up window always displays
the number of events that have actually occurred and been stored in the device.
Displaying events Display further information on a specific event from the event list by pressing
the event. The Holter window is displayed next. Each event is documented with
an IEGM recording, which has been stored in the Holter.
Event messages for
dual-chamber pacemakers
The following event notifications can be displayed for a dual-chamber pacemaker:
Event messages for
single-chamber
pacemakers
The following event notifications can be displayed for a single-chamber pace-
maker:
Note: If you click on an event message, the program will display the Holter list.
The events since last device follow-up are listed chronologically here.
Event text Meaning
Lead status changed The device has been switched to unipolar pacing.
You will find further information under
Statistics Pacing Lead impedance trend.
High ventricular rates Critical episode: Check Holter for HVR and adapt
programming if necessary. Check the ventricular
rate histogram to determine whether values
have occurred that are greater than or equal to
the upper rate.
You will find further information under
Statistics Timing Rate histograms.
Ventricle or atrium capture
control switched off
Capture control in the ventricle or in the atrium
has been switched off by the system.
Atrial overdrive pacing
switched off
Overdrive pacing in the atrium has been switched
off by the system.
Event text Meaning
Lead status The device has been switched to unipolar pacing.
You will find further information under
Statistics Pacing Lead impedance trend.
High rates Critical episode: Check Holter for HVR and adapt
programming if necessary. Check the ventricular
rate histogram to determine whether values have
occurred that are greater than or equal to the
upper rate.
You will find further information under
Statistics Timing Rate histograms.
Ventricular capture control
switched off
The capture control in the ventricle has been
switched off by the system.
206 Archive - Events - Measured Value Trends
Archiving Follow-up Results
Purpose The history provides a chronological overview of the follow-up measured values
stored since implantation.
Calling up the archive Select Follow-up Patient Last follow-up.
Program interface Follow-up history:
Functioning of
the history memory
The follow-up data is stored in the device and can thus be accessed by any
ICS 3000 device.
The values determined during implantation or the first follow-up and the values
of up to an additional nine follow-ups are displayed.
Once nine follow-ups have been recorded, the system overwrites the oldest
record beginning with the second follow-up. The data set recorded at implanta-
tion or the first follow-up remains saved.
207 Archive - Events - Measured Value Trends
TrendView - Overview of Important Measured Value Trends of the Device
Purpose TrendView provides a structured overview of the important measured value trends
since the last follow-up.
You can navigate in TrendView, call up individual events directly, view stored IEGMs
and print the TrendView with all important patient and device data. Events from the
event list are displayed directly beneath the cursor in TrendView with a comment
and the date.
Displaying TrendView Select [Follow-up] in the Test results [TrendView] group box.
Follow-up: TrendView
Displaying the measured
values of the device
The following measured values are displayed:
The average rate as well as the proportional atrium and ventricle pacing ratio
Thresholds in the atrium and ventricle if the capture control function has been
activated
P/R amplitudes
Lead impedances in the atrium and ventricle
208 Archive - Events - Measured Value Trends
Icons and list of events
in TrendView
The icons have the following meanings:
The following events are displayed in TrendView:
Icon Meaning
Event with entry of date, time and type of event
IEGM recording with entry of date and time
Event plus icon;
Details can be displayed by clicking on the surface
with the colored background.
Type Event
ERI The beginning of the replacement period has been reached for
the device. The date of the beginning of ERI is displayed.
Recording of the measured value trends ends at the beginning of
the replacement indication.
Ven. lead
check
Lead impedance in the ventricle indicates the date of checking
the lead.
Atr. lead
check
Lead impedance in the atrium indicates the date of checking the
lead.
Pt. Recording which has been triggered by the patient by
applying a magnet. An IEGM recording like this is possible
if this has been previously activated in
Parameters Home Monitoring/Diagnostics.
MSw Mode switching. An IEGM recording is available if this
has been previously activated in
Parameters Home Monitoring/Diagnostics.
VT High ventricular rate recorded, an IEGM recording is available.
AT High atrial rate recorded, an IEGM recording is available.
209 Archive - Events - Measured Value Trends
Meaning of the
arrow keys for navigation
The different arrows have the following functions:
Navigating in TrendView
and printing the results
You can navigate in TrendView as follows:
Icon Functions
Arrow keys with an icon which symbolizes an event.
You can navigate directly to the next event to the left
or right in TrendView.
Arrow keys to move the cursor to the left or right in
TrendView
Step Action
1 Select Follow-up TrendView to open the overview of the
measured value trend.
2 Select one of the arrow keys shown in the TrendView display to
move the cursor to a required point in time in TrendView.
3 Select the [Print] button in TrendView to print the measured
value trends.
210
12 Performing Manual Follow-up
Performing Manual Follow-up12365350-AEvia Function Manual
What's in this chapter? This chapter contains the following sections:
Section Topic Page
12.1 Manual Follow-up 211
12.2 Sensing Test 213
12.3 Threshold Test 217
12.4 Retrograde Conduction Test 225
12.5 Sensor Optimization 229
12.6 NIPS - Non-Invasive Programmed Stimulation 232
211 Performing Manual Follow-up
12.1 Manual Follow-up
What's in this section? This section contains the following topics:
Topic Page
Overview of Manual Follow-up Tests 212
212 Performing Manual Follow-up
Overview of Manual Follow-up Tests
Purpose If you do not want to perform the follow-up automatically with the standard
settings, you can initiate, configure and perform each test separately.
Follow-up test overview The following follow-up tests are possible:
Lead impedance (is automatically performed on an ongoing basis)
Sensing
Pacing threshold
Retrograde conduction
Sensor optimization
Initiate tests:
from the Follow-up window
From the Follow-up window, you can manually initiate interrogations and the
individual tests in the Test results group box. Proceed as follows:
Initiate tests:
from the Tests window
Display the Tests window and start the individual test as follows:
Evaluating statistics It may be necessary to evaluate the statistical data to get further information about
the cardiac status of the patient. Proceed as follows:
Step Action
1 Select the required test by clicking on the function name (link).
The software opens the window of the respective test or interroga-
tion.
2 Perform the test or interrogation.
3 If you would like to carry out further follow-up steps in this manner,
then you must open the Follow-up window manually again.
Step Action
1 Select the [Tests] button. The window is opened and displays each
test on a separate tab.
2 Select the tab for the required test.
3 Select [Start] and the test will be performed.
Step Action
1 Select [Statistics]. The window with the individual statistics tabs is
opened.
2 Select the required statistics recording on the tab.
3 Evaluate the data.
213 Performing Manual Follow-up
12.2 Sensing Test
What's in this section? This section contains the following topics:
Topic Page
Description of the P/R Amplitudes Sensing Test 214
Performing the P/R Amplitudes Sensing Test 215
214 Performing Manual Follow-up
Description of the P/R Amplitudes Sensing Test
Purpose The test for sensing the P/R amplitudes (sensing test) has the following clinical
benefit:
Evaluation of the position of the electrodes
Creating the prerequisites for additional electrophysiologic tests
Determining the optimal value for the device's Sensitivity parameter
Process sequence Sensing test sequence:
The test program is set with the suitable parameters. The following parameters
can be modified:
Test mode, basic rate and upper rate
Backup pulse amplitude and width in all chambers
IEGM (report) printing in realtime
Sensitivity
Pacing and sensing polarity in the atrium and ventricle
The following parameter cannot be changed:
AV delay; is only displayed in the DDI mode and is firmly set to 100 ms.
The test program is started. After the set duration has elapsed, the sensing test
ends automatically.
When the test is completed, the permanent program is automatically activated.
Results Depending on the test mode and the set parameters, the sensing test provides the
following results:
Display of minimum, mean and maximum signal amplitudes of the P/R waves
in each chamber
Display of mean rate if atrial sensed events occur
Note: In the DDI test mode, P/R amplitudes are measured at the same time.
215 Performing Manual Follow-up
Performing the P/R Amplitudes Sensing Test
Performing the sensing test
without backup
As long as you keep the [Intrinsic rhythm] button pressed, the sensing test will be
started without backup pacing. Proceed as follows:
!
!
WARNING
Interrupted telemetry can cause display of incorrect data
A communication error between the device and the programmer can cause false
data to be displayed on the programmer.
Always use an external ECG device during tests. Then the effectiveness of
measurement and the plausibility of the test results can be continuously
monitored at any time.
Step Action Comments
1 Select [Intrinsic rhythm] and
keep the button pressed.
The sensing test is running and
backup pacing is deactivated.
2 Release the [Intrinsic rhythm]
button to end the test.
When the test is completed,
the permanent program is
automatically set again.
!
!
WARNING
Interrupted telemetry with inadequate pulse amplitude
If the amplitude of the temporary program is not large enough during pacing
threshold or sensing tests to provide effective pacing, the patient may experience
a hemodynamically critical condition. An interruption in telemetry between the
device and the programmer can prevent the critical amplitudes from being
corrected.
Then simply reactivate the permanent program by taking the programming
head at least 30 cm away from the device.
216 Performing Manual Follow-up
Performing the sensing test Proceed as follows:
What to do if... Proceed as follows:
Step Action Comments
1 Select Tests Sensing. It is possible to begin the test
immediately with the preset values
or to edit the test parameters and
then to begin the test.
2 Use [Test mode] to select a
preset test program.
The following test programs are
available:
R measurement VVI
P measurement AAI
P measurement VDD
P and R measurement DDI
3 Select [Basic rate] and
decrease the basic rate to
a value that is below the
intrinsic rate.
Display of measured values:
Current individual measured
values are displayed on the
right next to the IEGM.
Mean measured values are
displayed in the Measured
values group box.
4 Select [Start] to perform the
test with the set values.
The test is performed.
5 Select [Stop] to terminate the
test.
The test ends.
6 Evaluate the mean measured
values and then decide whether
the permanent program needs
to be modified.
Optimization options:
Reposition the leads
Change sensing parameter
sensitivity
When the test is completed, the
permanent program is automati-
cally activated.
If ... Then...
no measurement results are
displayed,
check first whether the preset test mode
and rate are suitably set.
no measurement results are
printed,
check whether the Report parameter is
deactivated. Configure the feed rate to
activate the printout.
217 Performing Manual Follow-up
12.3 Threshold Test
What's in this section? This section contains the following topics:
Topic Page
Description of the Threshold Test 218
Conducting the Threshold Test 219
Threshold Test Parameters 223
218 Performing Manual Follow-up
Description of the Threshold Test
Purpose The threshold test determines the lowest value of pacing output needed to pace
the heart. Low values for the pulse widths or the pacing amplitudes increase the
service life of the device.
Test procedure In the threshold test, the pulse amplitude is reduced until a stimulus no longer
triggers a response from the heart. The last value that effectively paces is the
threshold.
Sequence The pacing threshold test sequence consists of the following procedures:
Determination of the pacing threshold
Evaluation and acceptance of the results
Adaptation of the permanent program
Results The test provides the following results:
Threshold values for the atrium and ventricle
Note: The threshold test can be carried out automatically or manually in the
atrium and ventricle. For safety reasons, the test is carried out as a temporary
program
219 Performing Manual Follow-up
Conducting the Threshold Test
Overview The following aspects are described:
Initiating the threshold test
Conducting the threshold test automatically
Preferences for the automatic threshold test
Conducting the threshold test manually
Determining the threshold
Evaluating and accepting the results
Adapting the permanent program
Initiating the threshold test Access the threshold test as follows:
!
!
WARNING
Interrupted telemetry can cause display of incorrect data
A communication error between the device and the programmer can cause false
data to be displayed on the programmer.
In order to continuously monitor the effectiveness of pacing and the accuracy
of the test results at any time, always use an external ECG device during tests.
!
!
WARNING
Telemetry interference with inadequate pulse amplitude
If the amplitude of the temporary program is not large enough during pacing
threshold or sensing tests to provide effective pacing, the patient may experience
a hemodynamically critical condition. An interruption in telemetry between the
device and the programmer can prevent the critical amplitudes from being
corrected.
Then simply reactivate the permanent program by taking the programming
head at least 30 cm away from the device.
Step Action
1 Select [Follow-up]. The automatically measured values for the
pacing threshold are displayed in the Test results group box.
Select [Capture threshold] to call the pacing threshold test function.
2 As an alternative, you can select [Tests] and [Capture threshold] to
call the threshold test function.
3 Select a test program, edit the program if necessary, and start the
test.
220 Performing Manual Follow-up
Conducting the threshold
test automatically
Proceed as follows to automatically run the threshold test with the preset
parameters:
Conducting the threshold
test manually
Proceed as follows:
Step Action
1 Select [Test mode] and one of the following modes to conduct the
threshold test automatically in the atrium or ventricle:
Atr. threshold DDI - AUTO
Ven. threshold DDD - AUTO
Ven. threshold VVI - AUTO
Ven. threshold VDD - AUTO
2 Select [Start].
3 During the test, observe the ECG monitor closely to cancel the test
immediately if necessary.
4 The measured pacing threshold is stored and displayed in the
Follow-up window in the Test results group box.
Step Action
1 Select a non-automatic Mode to conduct the threshold test in the
atrium or ventricle. These are all modes without the label AUTO.
2 Select [Start].
3 During the test, observe the ECG monitor closely to determine the
threshold value and cancel the test immediately if a pacing pulse is
no longer effective.
4 To end the test, press [Stop].
5 Accept the measured pacing threshold by selecting the found value in
the value window.
6 The measured pacing threshold is stored and displayed in the
Follow-up window in the Test results group box.
221 Performing Manual Follow-up
Determining the
threshold manually
The threshold is determined by transmitting test amplitudes to the device and
monitoring the effectiveness of the stimulus. Choose from the following options:
If ... Then...
1 you wish to select a
specific test amplitude,
select the desired value for the test amplitude.
The selected test amplitude is transmitted.
2 you wish to decrease the
test amplitude by one
step,
briefly press the [Reduce test amplitude]
button.
The test amplitude is decreased by one step.
As long as the test pulses are enabled, the
next ECG field displays the ECG segment that
immediately follows the test pulse.
3 you wish to automatically
decrease the test
amplitude,
select [Reduce test amplitude] and hold the
button down.
As long as the button remains pressed, the
test amplitude is automatically reduced.
Release the button when the value falls below
the pacing threshold. After releasing the
button, the safe start amplitude is immediately
activated.
222 Performing Manual Follow-up
Evaluating and
accepting the results
of the manual test
After the threshold test is ended, the Threshold window opens. Accept the
measured pacing threshold as follows:
Adapting the
permanent program
Proceed as follows:
Step Action
1 Evaluate and accept the measured pacing threshold by selecting the
value in the window.
2 Then print out the data.
The pacing threshold is printed out together with the parameters of
the program and the ECG sections that were displayed last.
Step Action
1 Set the parameters [Pulse amplitude] and [Pulse width] with
the measured value of the Threshold test plus safety margin in
the Parameters window in the Device tab.
2 Use [Program] to transmit the permanent program to the device.
!
!
WARNING
Inadequate pacing
The values determined during the threshold test may change between
follow-ups.
Always leave a sufficient safety margin for the values [Pulse amplitude] and
[Pulse width].
223 Performing Manual Follow-up
Threshold Test Parameters
Overview Preferences for the automatic threshold test
Selecting the test mode
Setting the basic rate
Switching the report on and off
Determining the resolution
Determining the number of pulses
Saving preferences
Preferences for the
automatic threshold test
The automatic threshold test is performed with fixed preset parameter values,
which cannot be changed by the user.
Setting the parameters of
the manual test program
The factory settings of the test program are usually suitable for the manual
threshold test. If needed, the parameters can be changed. The most important
parameters are explained below.
Selecting the test mode Proceed as follows:
Setting the basic rate Proceed as follows:
Switching the report
on and off
The Report parameter activates the automatic printout during the threshold test.
Dual-chamber devices Range of values
Atrial threshold test Current atrial rate up to 108 ppm max.;
AV delay 50 ms
Ventricular threshold test Atrial rate up to 110 ppm;
AV delay 50 ms
Single-chamber devices Range of values
Threshold test Current rate up to 110 ppm max.
Step Action
1 Use [Test mode] to select an established test program for the atrial
or ventricular threshold test.
Step Action
1 Set the [Basic rate] to a value above the patient's current intrinsic
rate.
Step Action
1 Use the Report parameter in the Setting group box to select the
paper speed for the ECG display and the printout.
224 Performing Manual Follow-up
Determining the resolution The resolution is a gradation of the values used by the test program to measure the
threshold. It determines the increment of the test amplitudes. At a low resolution,
only a few values are available in the high pulse amplitude range. This makes it
possible to run the threshold test very quickly in a few steps, but with reduced
precision. At a high resolution, all available values are included. This allows the
threshold test to be run with maximum precision.
Determining the
number of pulses
The Pulses parameter determines the number of test pulses triggered. When
activated, this function ensures that the patient will remain without pacing for no
longer than the set number of test pulses after falling below the pacing threshold.
After each of the programmed number of test pulses, the pacemaker automatically
returns to a safe start amplitude. When the function is deactivated, the set test
pulse remains active until the next value is set or the threshold test is terminated.
Saving preferences You can permanently save the selected parameter values as preferences in the
programmer. These settings will appear as the new standard values the next time
a manual threshold test is activated.
If... Then...
1 you select a
high resolution,
all values are displayed in the window for test
amplitudes from 7.5 V to 0.1 V.
2 you select a
low resolution,
a reduced number of values is displayed in the
window for test amplitudes.
Step Action
1 Enter the desired number for the Pulses parameter.
Step Action
1 Select More Preferences Tests to save preferences.
Note: Preferences do not apply to the automatic threshold test.
225 Performing Manual Follow-up
12.4 Retrograde Conduction Test
What's in this section? This section contains the following topics:
Topic Page
Retrograde Conduction Test 226
Conducting the Retrograde Conduction Test 227
226 Performing Manual Follow-up
Retrograde Conduction Test
Description This test determines whether retrograde conduction occurs and, if so, how long
the latency is.
The latencies measured are those between the right ventricle (pacing) and the
atrium.
Purpose Based on the determined conduction times, the timing parameters can be set, with
the objective of optimizing the hemodynamics and preventing pacemaker-induced
tachycardia.
Prerequisites The test can be performed only under the following conditions:
The device was successfully interrogated.
Pacing is possible in the right ventricle.
Sensing is possible in the right atrium.
The programming head has telemetry contact with the device for the entire
duration of measurement.
Sequence of the test The measurement is carried out as follows:
The user initiates the test, sets the parameters, and begins the measurement.
The system measures retrograde conduction between the selected chambers
applying the set parameters.
The following process sequence is carried out:
The ICS 3000 transmits the set temporary program to the implanted device
and starts the report function (real-time printing) if this function has been
activated.
The device activates and starts the test (temporary program).
The test automatically ends after ten pulses or, at most, after ten seconds
and the permanent program is reactivated in the device.
During measurement, the system displays the following:
In the IEGM Online display: the currently measured conduction time
The minimum, mean, and maximum conduction time, as well as the
average rate are calculated over multiple periods.
The system updates the display with every new measured value and displays
the message Test in progress. Please wait... in the status bar.
After finishing the measurement, a message in the software status bar provides
information on the success of the test and the current software status.
The user can now print out the measured results and the parameters.
The user can now change parameters if needed and begin a new measurement.
Results Since measurement of the retrograde conduction occurs over the course of several
pulses, the system delivers a mean, maximum and minimum value as the result.
Optimize the parameters based on these results.
227 Performing Manual Follow-up
Conducting the Retrograde Conduction Test
Performing test
with preset values
Proceed as follows to start the test with default values:
!
!
WARNING
Interrupted telemetry can cause display of incorrect data
A communication error between the device and the programmer can cause false
data to be displayed on the programmer.
In order to be able to continuously monitor the effectiveness of pacing and the
accuracy of the test results, always use an external ECG device during tests.
Step Action Result
1 Select
Tests Retrograde
conduction.
It is possible to begin the test immedi-
ately with the preset values or to edit
the test parameters and then to begin
the test.
2 Press [Start]. Measurement begins.
The [Stop] button is displayed in place
of the [Start] button. The test can be
canceled at any time with this button.
3 Select [Stop] to stop
the test prematurely.
The test ends automatically after
5 conductions or 10 seconds.
When report printing is activated,
the IEGM of this test is automatically
printed out.
4 Evaluate the measured
and displayed measure-
ment results.
Select [Print] to print
this data.
The displayed measurement results
and parameters are printed.
This data is not saved and cannot be
interrogated later on.
228 Performing Manual Follow-up
Performing the test
with changed values
Proceed as follows to conduct the test with changed values:
Step Action Comments
1 Select
Tests Retrograde conduc-
tion.
2 Select the rate that is to be used
for pacing during the test in the
Test program group box
under [Basic rate].
This rate must be higher than
the intrinsic heart rate.
The device works in VDI mode
during this test.
3 In the Test program group
box under [Report], select
whether the IEGM should be
printed out during the test and,
if so, the resolution of the
printout.
If this function is activated,
the report begins printing auto-
matically when the test starts.
4 Select A or V under
[Pulse amplitude] to set the
pacing amplitude.
5 Select A or V under
[Pulse width] to set the
duration of the pulse amplitude.
6 Set the sensing sensitivity in
the ventricle and atrium under
[Sensitivity].
7 Select the polarity of the
implanted lead for pacing under
[Pacing polarity].
Unipolar or bipolar
8 Select the polarity for the
implanted lead for sensing
under [Sensing polarity].
Unipolar or bipolar
!
!
WARNING
Inadequate parameters or interrupted telemetry
While a temporary program is running in control of the programmer,
interruptions in telemetry or the application of inadequate parameters could
put the patient into a hemodynamically critical state.
Continuously monitor the ECG and the patient's condition.
Reactivate the permanent program of the device if necessary by lifting the
programming head by at least 30 cm.
229 Performing Manual Follow-up
12.5 Sensor Optimization
What's in this section? This section contains the following topics:
Topic Page
Sensor Optimization 230
230 Performing Manual Follow-up
Sensor Optimization
Purpose Sensor optimization adjusts the sensor function in the device to the patient's needs
during the stress test.
Description For the duration of sensor optimization, create a rate profile of the patient by
performing stress tests. To do this, a fixed short-term trend of 16 minutes is
recorded, which documents the function of the sensor in the device during this
stress test.
After the stress test, interrogate the device again and suggestions for setting the
device's sensor parameters in the sensor optimization window will be provided.
The parameters can be changed and further optimized.
Then adopt the suggestion and check to make sure that the changed parameters do
not result in conflicts with other parameters. The program with sensor optimiza-
tion is then transmitted to the device permanently.
Performing sensor
optimization
The device was successfully interrogated for the first time. The standard statistics
were are also interrogated in this process. Proceed as follows to perform sensor
optimization:
Step Action
1 Select [Tests] to access the sensor optimization function.
2 Select [Sensor optimization] to initiate the sensor optimization
function. The statistics are empty the first time sensor optimization is
called.
3 Select [Start]. A message indicates that a fixed short-term trend has
to be set for sensor optimization.
Confirm the notification with [OK] to start the fixed short-term trend.
4 Have the patient complete the stress test and then interrogate the
device again by positioning the programming head.
5 Change the parameters for rate adaptation directly in the Sensor
optimization window until the preview curve of the trend chart
meets your expectations.
Select [Accept parameters] to check the changed settings in the
Parameters window on the Device tab with regard to possible
parameter conflicts.
Transmit the changed parameter settings to the device using the
[Program] button.
Note: Error message during sensor optimization.
If the capture control status is set to inactive, then sensor optimization cannot be
started. Check the capture control function.
231 Performing Manual Follow-up
Details on the
simulation preview
The sensor optimization window also includes the parameters for rate adaptation.
These correspond to the settings that are valid while the trend is being recorded.
Note: If sensor optimization has been performed with a pacing mode without
rate adaptation, then the corresponding rate-adaptive program is shown as a
parameter suggestion.
232 Performing Manual Follow-up
12.6 NIPS - Non-Invasive Programmed Stimulation
What's in this section? This section contains the following topics:
Topic Page
NIPS - External Pulse Control 233
NIPS - Selecting Therapy and Setting Parameters 234
NIPS - Description of Burst Stimulation 235
NIPS - Executing Burst Stimulation 236
NIPS - Description of Programmed Stimulation 239
NIPS - Executing Programmed Stimulation 241
233 Performing Manual Follow-up
NIPS - External Pulse Control
Overview Description of external pulse control
Purpose
Characteristics
Functional description
Purpose Pulse delivery of the device can temporarily be controlled using the programmer
for the acute therapy of certain arrhythmias. No additional external device is
required.
External pulse control is only possible in the atrium with dual chamber devices.
Characteristics Programs for external pacing are set in the Test window in the NIPS tab.
They include the following features:
Safe program (backup stimulation)
It is possible to select the following therapies depending on the objective:
Burst stimulation
Programmed stimulation
How NIPS works NIPS works as follows:
!
!
CAUTION
Triggering arrhythmias
Non-invasive programmed stimulation (NIPS) may only be performed by physi-
cians familiar with high-rate stimulation procedures. Dangerous arrhythmias or
even ventricular fibrillation may occur, depending on the patients individual
pacing protocol and predisposition. For this reason, please observe the usual
safety precautions for conducting electrophysiologic examinations.
Topic Description
Transmission Upon starting the backup program (safety pacing),
the pacemaker is set to a standby mode.
In this mode, the pacemaker can directly execute the
pacing pulses transmitted by the programmer.
Maximum rate External pulse control is possible with a maximum rate
of 800 ppm. This corresponds to a pacing interval of
80 ms.
Continuous pacing/
pause
Continuous pacing is performed. After the entire
sequence is complete (set number of cycles with basic
interval and coupled extrastimuli), the Pause parameter
takes effect.
The value for Pause is entered in ms and determines
the duration of the pause interval. After the pause
has elapsed, the complete sequence is automatically
repeated. This occurs until programmed stimulation
is canceled.
If the Stop value is set, then the sequence is not
automatically repeated. Pacing only proceeds when
programmed stimulation is restarted.
Backup stimulation in
the ventricle
In external dual-chamber stimulation, backup
stimulation in the ventricle generally has priority
over atrial pacing.
It is therefore possible that a single pulse of the atrial
pulse cycle is omitted when a pace of the safety
program is triggered simultaneously in the ventricle.
234 Performing Manual Follow-up
NIPS - Selecting Therapy and Setting Parameters
Overview Initiating NIPS
Selecting the therapy:
Burst stimulation
Programmed stimulation
Setting parameters for backup stimulation
Switching the report on and off; default settings
Initiating NIPS Proceed as follows:
Selecting the
form of therapy
Proceed as follows:
Setting parameters for
backup stimulation
Parameters for setting the safe program (backup stimulation) are on the left side of
the NIPS window.
Form of therapy
Mode
Basic rate
Report
Pulse amplitude
Pulse width
Sensitivity
Pacing polarity
Sensing polarity
Step Action
1 Select [Tests] and then [NIPS].
If... Then...
you want to trigger a pulse train
with fixed or variable rate
(ramp function),
select Form of therapy Burst stimula-
tion.
you want to trigger a full electro-
physiological stimulation program
with up to four extrastimuli
(like UHS).
select Form of therapy Programmed
stimulation.
235 Performing Manual Follow-up
Proceed as follows:
The parameters of the safety program (backup stimulation) cannot be changed
during burst stimulation. This is only possible if burst stimulation is previously
switched off.
Switching the report
on and off
An automatic report is offered for NIPS. If it is activated, then the ECG is printed
automatically. At the end of transmission, the used pacemaker program is also
printed out.
You can switch this automatic report on or off and store it as a permanent
preference setting in the programmer.
Report default settings Proceed as follows:
NIPS - Description of Burst Stimulation
Description Burst stimulation allows for triggering a pulse train with fixed or variable rate
(ramp function) as long as the [Burst] key remains pressed.
Programmed stimulation is only possible in the atrium with dual chamber devices.
The parameters for burst stimulation are on the right side of the NIPS window.
Step Action
1 Select the parameters and set the desired values.
Step Action Comments
1 Select [Stop backup program]. External pulse control is
cancelled and the permanent
program is transmitted to the
device.
Note: Independent of the option of canceling, external pacing can be stopped at
any time by lifting the programming head (at least 30 cm). The pacemaker then
switches back to its permanent program.
Step Action
1 Select More Preferences Tests NIPS to save the prefer-
ences for the report function. These settings will be displayed as
the new standard values the next time the function is activated.
Parameter Description
Pacing site Chamber for burst stimulation; only possible in the atrium
Coupling interval Burst stimulation is only started after the coupling interval
has passed. The coupling interval is started with the first
pacing or sensing event after pressing the [Burst] key.
If the value is WITHOUT, then burst stimulation is started
immediately (asynchronous).
Burst rate Fixed rate for burst stimulation
Burst min. Minimum rate with decreasing ramp
Burst max. Maximum rate with increasing ramp
Ramp function The increment for increasing and decreasing the ramp
function is preset to 10 ppm/s and cannot be changed.
236 Performing Manual Follow-up
NIPS - Executing Burst Stimulation
Overview Selecting burst stimulation
Executing burst stimulation
Starting the backup program (safety pacing)
Releasing the function
Starting/stopping burst stimulation
Varying the burst rate during pacing
Selecting burst stimulation Proceed as follows:
User interface NIPS: Start backup program
!
!
CAUTION
Triggering arrhythmias
External pulse control may only be performed by physicians familiar with
high-rate stimulation procedures. Dangerous arrhythmias or even ventricular
fibrillation may occur, depending on the patients individual pacing protocol and
predisposition. For this reason, please observe the usual safety precautions for
conducting electrophysiologic examinations.
!
!
WARNING
Interrupted telemetry can cause display of incorrect data
A communication error between the device and the programmer can cause false
data to be displayed on the programmer.
In order to continuously monitor the effectiveness of pacing and the accuracy of
the test results at any time, always use an external ECG device during tests.
Step Action
1 Select [Tests] and then [NIPS].
2 Select [Burst stimulation] to trigger a pulse train with fixed or
variable rate (ramp function),
237 Performing Manual Follow-up
Starting/stopping
burst stimulation
Proceed as follows:
User interface NIPS: Burst stimulation
Step Action Result
1 Select
[Start backup program].



A window is displayed which informs
you of possible risks and requests you
to release (confirm) activation of the
function.
2 Select [Release] if you
would like to start burst
stimulation.
External pulse control is enabled in the
pacemaker as a temporary program.
The status bar displays: NIPS:
backup program is active.
Pacing is controlled or ensured by the
backup program (safety pacing).
3 Press the center of the
[Burst] button and keep
the button pressed for the
duration of the burst.
As long as the key remains pressed,
burst stimulation at the specified rate
will accompany safety pacing. When
the key is released, only safety pacing
is active.
4 Select [Stop backup
program].
External pulse control is cancelled and
the permanent program is transmitted
to the device.
238 Performing Manual Follow-up
Varying the burst rate
during pacing
The burst rate can be gradually changed during pacing (ramp function).
This ramp function is facilitated by a three-part key.
If ... Then ...
you want to increase the
burst rate,
press on the right part [ >] of the [Burst] button and
keep the button pressed for the duration of the
burst.
Based on the preset value, the burst rate is
increased incrementally until the specified
maximum has been reached. When you let go of
the key, backup stimulation is active.
you want to decrease the
burst rate,
press on the left part [ <] of the [Burst] button and
keep the button pressed for the duration of the
burst.
Based on the preset value, the burst rate is
decreased incrementally until the specified
minimum has been reached. When you let go of
the key, backup stimulation is active.
you want to cancel burst
stimulation
release the [Burst] button. After releasing the
button, the burst stimulation is automatically ended.
Backup stimulation remains active.
!
!
CAUTION
Reduced pulse amplitude due to a battery voltage drop
If the rate and amplitude are set very high and the pulse width is set too long at
the same time, the battery voltage may temporarily drop so low that the actual
pulse amplitude drops well below the selected level. Therefore, continuously
check the pacing efficiency using ECG monitoring.
239 Performing Manual Follow-up
NIPS - Description of Programmed Stimulation
Description With programmed stimulation, it is possible to trigger a full electrophysiological
stimulation program with up to four extrastimuli.
Programmed stimulation is only possible in the atrium with dual chamber devices.
The following parameters can be configured for programmed stimulation.
Coupling pacing
intervals 1 to 4
The extrastimuli are coupled to the basic interval as follows:
Parameters Description
Pacing site Chamber for programmed stimulation; only possible in the
atrium
S1 - S1 Basic interval for programmed stimulation
Cycles The basic interval is repeated for the specified number of
cycles before the extrastimuli are added. If the value 0 is
specified, the extrastimuli are effected immediately after
the start of the basic interval.
S1 - S2
S2 - S3
S3 - S4
S4 - S5
Intervals of the extrastimuli that are coupled to the basic
interval. The method is described below and applies to all
intervals of the extrastimuli.
Decrement This parameter specifies whether the sequence is to be
repeated unchanged or modified after the pause.
Pause After the entire sequence is complete (set number of cycles
with basic interval and coupled extrastimuli), the Pause
parameter takes effect.
The value for Pause is entered in ms and determines
the duration of the pause interval. After the pause has
elapsed, the complete sequence is automatically
repeated. This occurs until programmed stimulation is
canceled.
If the Stop value is set, then the sequence is not
automatically repeated. Pacing only proceeds when
programmed stimulation is restarted.
If ... Then ...
pacing is to be carried out
without the first extra stimulus
(S1 - S2 = WITHOUT),
all further extrastimuli are also not coupled.
a numerical value is entered
for S1 - S2,
the first extra stimulus is coupled after the
set cycles of the basic interval are complete.
Stimulation takes place at the end of the
S1 - S2 interval.
pacing is carried out without
the second extra stimulus
(S2 - S3 = WITHOUT),
all further extrastimuli are also not coupled.
a numerical value is entered
for S2 - S3
the first extra stimulus and then the second
extra stimulus is coupled after the set cycles
of the basic interval are complete. Stimulation
occurs at the end of the S1 - S2 and S2 - S3
intervals, respectively.
240 Performing Manual Follow-up
Decrementing extrastimuli The decrement parameter functions as following:
Displaying current values
If ... Then ...
the value 0 is set the sequence is repeated in the same manner
after the pause.
a value other than 0 is set, the interval is shortened by the set value
before the last active extra stimulus. This
happens with every repetition of the sequence.
Displayed values Description
Current Next to the interval of the last active extra
stimulus, there is a field indicating the current
interval value. This is based on the value for
the set parameter decrement.
!
!
CAUTION
Reduced pulse amplitude due to a battery voltage drop
If the rate and amplitude are set very high and the pulse width is set too long at
the same time, the battery voltage may temporarily drop so low that the actual
pulse amplitude drops well below the selected level. Therefore, continuously
check the pacing efficiency using ECG monitoring.
241 Performing Manual Follow-up
NIPS - Executing Programmed Stimulation
Overview Initiating NIPS
Selecting programmed stimulation
Executing programmed stimulation
Starting the backup program
Releasing the function
Starting and stopping programmed stimulation
Selecting programmed
stimulation
Proceed as follows:
User interface NIPS: Starting programmed stimulation
!
!
CAUTION
Triggering arrhythmias
External pulse control may only be performed by physicians familiar with
high-rate stimulation procedures. Dangerous arrhythmias or even ventricular
fibrillation may occur, depending on the patients individual pacing protocol and
predisposition. For this reason, please observe the usual safety precautions for
conducting electrophysiologic examinations.
!
!
WARNING
Interrupted telemetry can cause display of incorrect data
A communication error between the device and the programmer can cause false
data to be displayed on the programmer.
In order to continuously monitor the effectiveness of pacing and the plausibility of
the test results at any time, always use an external ECG device during tests.
Step Action
1 Select [Tests] and then [NIPS].
2 Select [Programmed stimulation] to trigger a full electro-
physiological stimulation program with up to four extrastimuli
(like UHS).
242 Performing Manual Follow-up
Executing programmed
stimulation
Proceed as follows:
Step Action Result
1 Select
[Start backup program].
A window is displayed which informs
you of possible risks and requests you
to release (confirm) activation of the
function.
2 Select [Release] if you
would like to start
programmed stimulation.


External pulse control is enabled in the
pacemaker as a temporary program.
The status bar displays: NIPS backup
program is active.
Pacing is controlled or ensured by the
backup program (safety pacing).
3 Select
[Start programmed
stimulation].
External pulse control is enabled in the
pacemaker as a temporary program.
Pacing is controlled or ensured by the
safety program (backup stimulation)
set in the NIPS window.
Programmed stimulation commences
in addition to backup stimulation. This
remains active until the set sequence
has been carried out in full or until the
function is ended manually. Then, only
backup stimulation will remain active.
4 Select
[Stop progr. stimulation].
External pacing is canceled and the
permanent program is transmitted to
the device.
243 Performing Manual Follow-up
User interface NIPS: Stop progr. stimulation
!
!
CAUTION
Reduced pulse amplitude due to a battery voltage drop
If the rate and amplitude are set very high and the pulse width is set too long at
the same time, the battery voltage may temporarily drop so low that the actual
pulse amplitude drops well below the selected level. Therefore, continuously
check the pacing efficiency using ECG monitoring.
244
IV ProMRI
ProMRI IV365350-AEvia Function Manual
What's in this part? This part contains the following chapters:
Overview See part IV for further information on conditions and instructions for the MR scan.
Chapter Chapter name Page
13 MRI Examination 245
245
13 MRI Examination
MRI Examination13365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Target Group 246
Intended Medical Use 247
An Overview of MR Conditional BIOTRONIK Products 248
Magnetic Resonance Imaging - Possible Interactions 250
Contraindications 251
Preconditions and Basic Conditions for all Products 252
Conditions for Specific Products 253
Preliminary Examination 255
MRI Examination 256
Follow-up 257
MR Conditional Symbol on the Label 257
246 MRI Examination
Target Group
Cooperation between
professionals from
two areas of expertise
This manual is directed at physicians and medical personnel with required
knowledge and experience for the preparation and usage of an MR scan on patients
with pacemakers.
Preparation and usage of an MR scan on a pacemaker patient requires close
cooperation between a cardiology professional as a specialist for the pacing system
and a radiology professional as a specialist for the MR scan.
The following sections describe the tasks that each of these specialists are
responsible for.
Knowledge required by the
cardiology specialist
A cardiology professional is required to select and/or approve the patient for the
MR scan. Additionally, they must test the pacing system before the exam, put it in
a special MRI mode, ensure its functionality after the exam and program it back to
the mode which was active before the MR scan.
The expert knowledge required by the cardiologist include the following areas and
subjects:
Application of pacemaker therapy.
Handling the BIOTRONIK programmer and especially the following activities:
Interrogating the active device
Performing follow-up
Switching parameters
All associated risks, possible side effects and the appropriate safety and
therapy measures.
Knowledge required by the
radiology specialist
The radiology professional is responsible not only for successful performance of
the MR scan for the purposes of the desired diagnosis, but must also make sure
that the restrictive conditions, under which the exam is to be performed, are
observed both before and during the exam.
The expert knowledge required by the radiology professional include the following
areas and subjects:
Handling MRI scanners
Preparation, performance and analysis of MR scans
247 MRI Examination
Intended Medical Use
Active device and lead The intended use of pacemaker and lead also applies to the use of the pacing
system.
Patient selection,
MRI indication
Before a patient with an implanted MR conditional pacing system is selected for
an MR scan, the following issues must be resolved:
There must be a clear indication for the MR scan.
This means that there is no doubt as to the predictable diagnostic benefit of the
MR scan and that comparable results can not be achieved with other less risky
procedures.
Risk/benefit analysis
All of the exclusion criteria listed in these instructions have been taken into
consideration.
The described restrictions and conditions for the MR scan are to be observed at
all times.
Intended use In the past, MR scans were always contraindicated for pacemaker patients.
If particular prerequisites and conditions are fulfilled, MR scans can now be
conducted on patients with a combination of a BIOTRONIK active device and lead
that has been tested for this.
Residual risk The expectable risks and hazards are minimized by the measures performed in
this manual. Nevertheless, a residual risk remains.
Note: The technical manual for the active device is to be observed in this regard.
248 MRI Examination
An Overview of MR Conditional BIOTRONIK Products
Devices and pacing systems The behavior of a precisely defined pacing system, consisting of a pacemaker and
at least one lead, has been tested under the conditions of an MRI examination and
labeled MR conditional.
However, due to the fact that both the active device and the lead are sold indepen-
dently of each other, this manual informs the user about which specific combina-
tions of an active device and a lead are MR conditional, and on the specific condi-
tions, and requirements that are to be observed for the respective combination.
MRI approval in
the country or region
If you are planning to perform an MR scan with an MR conditional BIOTRONIK
pacing system, please contact the responsible authorities beforehand to determine
whether these products are actually certified MR conditional in your country or
region.
MR conditional pacemakers The following pacemaker and lead models are MR conditional:
MR conditional Evia models:
MR conditional Entovis models:
MR conditional Estella models:
MR conditional Ecuro models:
Model Order number: uncoated Order number: coated
Evia DR-T 371996 372032
Evia DR 371995 372031
Evia SR-T 371998 372034
Evia SR 371997 372033
Model Order number: uncoated Order number: coated
Entovis DR-T 371992 372028
Entovis DR 371991 372027
Entovis SR-T 371994 372030
Entovis SR 371993 372029
Model Order number: uncoated Order number: coated
Estella DR-T 371207 371208
Estella DR 371205 371206
Estella SR-T 371200 371196
Estella SR 371209 371204
Model Order number: uncoated Order number: coated
Ecuro DR-T 375439 375440
Ecuro DR 375437 375438
Ecuro SR-T 375435 375436
Ecuro SR 375433 375434
249 MRI Examination
MR conditional lead models The following leads are MR conditional:
Lead Safio S:
Lead Solia S:
Lead Solia T:
MR conditional
pacing systems
The following pacemakers comprise the MR conditional pacing systems in
combination with the leads named below:
Evia SR (T), DR (T), coated and uncoated versions
Entovis SR (T), DR (T), coated and uncoated versions
Estella SR (T), DR (T), coated and uncoated versions
Ecuro SR (T), DR (T), coated and uncoated versions
These pacemakers can be combined with the following leads:
Safio S 53
Safio S 60
Or:
Solia S 45
Solia S 53
Solia S 60
Solia T 53
Solia T 60
Lead model Order number
Safio S 53 370945
Safio S 60 370946
Lead model Order number
Solia S 45 377176
Solia S 53 377177
Solia S 60 377179
Lead model Order number
Solia T 53 377180
Solia T 60 377181
!
!
CAUTION
Limitation due to lead combinations that are not MR conditional
To constitute an MR conditional pacing system, connect in each case only Safio or
Solia models to one of the listed pacemakers.
The combination of Safio and Solia leads in a pacing system is not tested
MR conditional.
250 MRI Examination
Magnetic Resonance Imaging - Possible Interactions
Problematic interactions Significant mechanisms which can lead to problematic interactions with implanted
pacing systems are described here.
Therefore, use of MR scans for cardiac pacemaker patients is generally contra-
indicated.
MR conditional
BIOTRONIK devices
BIOTRONIK has, with its MR conditional pacing systems, developed MR conditional
BIOTRONIK devices where the effects on pacing systems and patients listed below
are minimized.
For this combination of lead and active device, conditions required for the respon-
sible performance of MR scans have been tested and explained in this manual.
Fields in the
MRI scanner
The following three types of fields are generated in an MR scan:
Static magnetic field
This is a consistently strong, rectified magnetic field which is constantly emitted
in the MRI scanner and its immediate surroundings even if no examination is
being performed.
Gradient magnetic fields
These are low-frequency pulsed magnetic fields with a relatively low amplitude.
During MRI scanning, the patient is exposed to three vertical gradient magnetic
fields that are facing towards each other.
HF field (high frequency field)
This is an electromagnetic field in the high frequency range.
It is also effective only during a scanning and is usually generated by different
transmission coils created especially for scanning certain parts of the body.
Action of force of the
static and gradient
magnetic fields
Implanted ferromagnetic materials are subject to the action of force of these
magnetic fields.
This means that implanted devices can subject the surrounding tissue to pressure,
tensile force or vibrations.
Construction and choice of material in our MR conditional devices and compliance
with the specified conditions serve to reduce these stresses to a minimum.
Interactions resulting
from induced AC voltages
Gradient magnetic fields and electromagnetic high frequency fields can induce
electrical AC voltages in metallic devices.
In some cases, these electrical energies can result in undesirable pacing or
have a negative impact on the pacemaker.
Constructive measures on the MR conditional devices and the restrictive
prerequisites for the arrangement and usage of the MR scan reduces the proba-
bility of occurrence and strength of this effect. However, this effect cannot be
entirely excluded.
Among other things, corresponding emergency precautions have to be taken in
this case.
251 MRI Examination
Thermal interactions High-frequency electromagnetic fields induce electric voltages in the lead which
cause current conduction through the lead and the tissue electrically connected to
the lead.
This flow of current in turn causes warming at the electrical points of contact
between the lead and the tissue which can result in thermal damage to the
surrounding tissue.
This thermal tissue damage can be temporary or lasting and can be evidenced by
the deterioration of the lead's pacing and sensing functions.
Gradient magnetic fields can cause warming of the device housing which can lead
to thermal exposure and damaging to the surrounding tissue.
Due to the constructive composition of the MR conditional devices, and the compli-
ance with the tested conditions and restrictions for the MR scan, these thermic
effects are kept to a tolerable measure.
Image interference
and artifacts
Not only can the MR scan have undesirable effects on the patient or the pacing
system, but the implanted devices can also have a negative impact on the MR scan.
If the devices are outside the scanning area, then they only cause slight image
distortion and interference.
If a device is within the area shown by the MRI scanner, then artifacts, distortion
and interference are probable. Consider this when selecting the image calculation
parameters and the depicted area.
Contraindications
Preliminary notes Indications and contraindications for the implantation of certain leads and pace-
makers and the application of the respective cardiological therapies are not the
subject of this manual, but should be obtained from the user manuals of the
respective devices.
This manual only deals with aspects that are relevant within the MR scan context.
The manual does not deal with the contraindications of MRI applications, which
do not result from interactions with an implanted pacing system.
Contraindications An MR scan on a pacing system patient is always contraindicated for pacing
systems which have not been labeled MR conditional by BIOTRONIK and have
not been certified for MR applications by a responsible authority.
An MR scan on a patient with an MR conditional pacing system is also contra-
indicated when any of the conditions listed under Preconditions and Basic
Conditions for all Products, p. 252 is not adhered to.
An MR scan on a patient with an MR conditional pacing system is also contra-
indicated when one of the specific conditions that applies to a particular pacing
system is not adhered to.
Note: Permissible positioning range
A permissible positioning zone for each MR conditional pacing system is speci-
fied in the relevant part of this manual.
The limits of the permissible positioning zones regulate the size and location of
the scan exclusion zone.
252 MRI Examination
Preconditions and Basic Conditions for all Products
Basic principles Safe usage of an MR scan on a patient having an implanted pacemaker is only
possible under highly specific prerequisites and conditions.
MRI use is contraindicated in any other cases.
Preconditions for
the patient and
the pacing system
The following requirements must always be fulfilled to perform an MR scan
with inclusion of a BIOTRONIK pacing system.
The implanted system consists only of a lead and a pacemaker, which are each
labeled MR conditional separately, and in combination make up an MR condi-
tional system (See An Overview of MR Conditional BIOTRONIK Products,
p. 248).
There are no other implants in the patient's body.
For example:
Other pacemakers or ICDs
Leads no longer in use
Lead adapters
Lead extensions
The patient does not have fever.
The patient's height is at least 1.4 meters.
The pacing system has been implanted for at least 6 weeks.
The implanted pacing system is in the patient's chest area.
The calculated pacing threshold does not lie above 2.0 V at 0.4 ms pulse width.
The ascertained lead impedance is between 200 and 1500 Ohms.
The pacemaker is reprogrammed to a special MRI mode immediately before
the MR scan.
The conditions applicable to specific devices or pacing systems such as specific
permissible positioning zones, minimum patient height, etc. are observed.
(See Conditions for Specific Products, p. 253) in this manual.
Requirements of
the MRI scanner
The MRI scanner has to meet the following conditions:
Use of a clinical MRI system with a closed tube, cylindrical magnets and a static
magnetic field strength of 1.5 tesla.
The slew rate of the MRI scanner's gradient fields should not exceed 200 T/m/s.
No additional local transmitting coils are used.
Restrictions during
the MR scan
The following conditions must be met during the MR scan:
The MR scan can only be performed with the patient in dorsal position.
The permissible positioning zone defined in the 'Conditions for specific
products' section has to be observed.
The overall MR scanning time accumulated from the imaging times as
displayed by the MRI scanner must not exceed 30 minutes.
The mean specific absorption rate for the whole body displayed by the
MRI scanner must not exceed 2.0 W/kg.
The head absorption rate displayed by the MRI scanner must not exceed
3.2 W/kg.
Emergency equipment for reanimation must be kept at hand and properly
certified staff must be available.
During the entire MR scan, the ECG and the blood pressure or the ECG and
the blood oxygen saturation of the patient must be monitored continuously.
Only use devices for this which are permitted for patient monitoring in
an MRI environment.
Specific conditions for the respective pacing systems have to be observed in
addition.
Note: The ECG function integrated in the MRI scanner is often not permitted for
patient monitoring.
253 MRI Examination
Conditions for Specific Products
General information Some prerequisites and conditions for the conduction of an MR scan apply for more
than one possible device combination, other conditions are specifically defined for
an according device combination.
This section describes the conditions for specific pacing systems.
Evia, Entovis, Estella or
Ecuro pacemaker with
Safio S, Solia S or
Solia T lead
The following specific conditions for use apply to the pacemaker models in the
following list in combination with the leads listed subseqently.
One of the following pacemaker models:
Evia SR (T), DR (T)
Entovis SR (T), DR (T)
Estella SR (T), DR (T)
Ecuro SR (T), DR (T)
In combination with the following lead models:
Safio S 53
Safio S 60
Or in combination with the following lead models:
Solia S 45
Solia S 53
Solia S 60
Solia T 53
Solia T 60
In addition to the preconditions and basic conditions for all products, the following
special conditions apply to this combination of pacemaker and lead:
The total length of examination for the pacing system must be below 10 hours.
Explanation of the term 'total length of examination':
When a patient with an implanted pacing system is succumbed to several
MRI examinations in a row, the length of each examination is recorded and
these times are accumulated. This sum is almost equal to the total exposition
time during which the devices were exposed to the strong magnetic field.
Adherence to the permissible positioning ranges.
The permissible positioning ranges are bodily regions upon which a laser mark
may be set in order to position the isocentre of the MRI scanner.
These areas absolutely have to be adhered to during the MR scan.
However, receipt only coils can also be positioned outside this area.
As a result of this limitation and due to the technical givens of the MRI scanner,
no imaging data can be collected for this part of the body (the scan exclusion
zone).
!
!
CAUTION
Limitation due to lead combinations that are not MR conditional
To constitute an MR conditional pacing system, connect in each case only Safio or
Solia models to one of the listed pacemakers.
The combination of Safio and Solia leads in a pacing system is not tested MR
conditional.
254 MRI Examination
Permissible
positioning zone and
scan exclusion zone
The following applies for the pacing systems named above:
Sketch: permissible positioning zone and scan exclusion zone
Legend:
1) Scan exclusion zone
2) Permissible positioning zone
Starting from the foot end, the maximum allowed positioning mark for the
isocenter is at the hip bone level.
Starting from the top of the skull, the maximum allowed positioning mark for
the isocenter is at the level of the eyes.
255 MRI Examination
Preliminary Examination
Cooperation between
specialists
Preparation and usage of an MR scan on a patient with a pacemaker requires close
cooperation by a specialist for the implanted pacing system and a specialist for
the MRI technology and examination.
One of these specialists has to perform the steps described in the following for
preparation of the MR scan, the patient and his or her implanted pacing system.
The person responsible for each task depends on the concrete activity or context.
Checking the suitability of
the patient and the
implanted pacing system
Cardiology and radiology professionals are required for this step.
Preliminary cardiological
examination and
MRI programming
Once the conditions for an MR scan have been clarified, preliminary examination
and programming to an MRI mode by the cardiologist is the final and definitive
preparation measure.
Step Action
1 Check and ensure that all requirements described in sections
Preconditions and Basic Conditions for all Products, p. 252 and
Conditions for Specific Products, p. 253 are met pertaining to
the patient and the pacing system.
2 Make sure the technical and clinical basic conditions for the
MR scan can be met and that the necessary preparations have
been made.
Step Action
1 Apply the programming head of the programmer to the chest and
interrogate the pacemaker.
2 Perform full follow-up.
In doing so, check the following preconditions for the MR scan:
Pacing threshold: max. 2.0 V / 0.4 ms
Lead impedance: 200 ... 1500 O
Battery charging status: at least 30%
3 Open the MRI program window.
There are two ways to open the MRI program window:
Select Follow-up MRI.
Select Parameters Bradycardia Programs
Show MRI program.
4 Carefully read the preconditions and basic conditions in the
MRI checklist window. Confirm observance of these conditions
by placing a checkmark in the checkbox.
The software will not permit further programming of an MRI mode
without this confirmation.
!
!
WARNING
Health risk to patients if pacemaker is switched off
If the OFF mode is set in the following step, continual cardiological monitoring of
the patient must be ensured throughout this time.
256 MRI Examination
MRI Examination
Prerequisites The following conditions have to be met:
The contraindications listed in the respective sections as well as the required
preconditions and basic conditions are taken into consideration.
The patient is previously examined by a cardiology professional and the
implanted pacing system is switched to a mode especially suitable for
an MR scan.
The technical and organizational conditions are met to be able to observe
the restrictions and safety measures required during the MR scan.
Emergency equipment for reanimation (including specialist staff certified to
use it) is available.
Basic conditions and
restrictions
The conditions that have to be met during an MR scan are listed in section
Preconditions and Basic Conditions for all Products, p. 252 under the subheading
'Basic conditions and restrictions during the MR scan'.
In addition to this, the 'Conditions for specific products' defined in section
Conditions for Specific Products, p. 253 for the respective pacing systems have
to be observed.
Completion of
the examination
After completing the MR scan, it must be ensured that the patient is again
monitored by a cardiology professional, who performs the required cardiological
follow-up and reprogramming of the pacing system.
5 Activate one of the four possible MRI modes: D00, A00, V00, OFF
The OFF setting is recommended for patients not dependent on
their pacemaker.
One of the asynchronous pacing modes (D00, A00, V00) is
recommended for pacemaker-dependent patients depending
on the particular indication.
The magnet effect is automatically set to SYNC (synchronous).
The pacing amplitude is preset to 4.8 V / 1.0 ms here, at a fixed
pacing rate of 80 ppm. Home Monitoring and all automatic
functions are deactivated.
Note: You will leave the MRI program if you change any parameters prior to
sending.
6 Transmit the MRI program to the pacemaker.
Note: When programming the MRI mode, the original device settings are saved in
the programmer.
If you perform cardiological follow-up and reprogramming using the same
programmer after completing the MR scan, then you can invoke these settings
again and thus simplify restoring the state from before the MR scan.
7 Print and document follow-up data (print report).
8 Finish the preliminary examination of the patient.
Make sure that the patient can be immediately submitted to
cardiological follow-up after completion of the MR scan.
257 MRI Examination
Follow-up
After the MR scan Subsequent to the MR scan, the patient must immediately undergo cardiological
follow-up.
This is necessary for the patient's safety for two reasons:
To switch the active device back into a mode which provides the patient with
adequate therapy.
To check whether damage has been incurred to the pacing system or to the
heart muscle during the MR scan.
Cardiological
follow-up procedure
The cardiological examination following an MR scan is to be performed as follows:
MR Conditional Symbol on the Label
There is a sticker with product information and symbols which are explained in
the user manual provided in the packaging of the BIOTRONIK devices.
The packaging of MR conditional products under the brand name ProMRI is
additionally labeled with the following symbol:
1 Apply the programming head
2 Interrogate the device
3 Reactivate the program that was active prior to programming the
MRI mode
4 Permanently transfer the program to the device
5 Perform of a complete follow-up
6 If necessary: conduct further examinations
7 Print (print protocol) and document follow-up data
8 Complete the follow-up examination for the patient
MR conditional:
Patients who have a pacing system with devices labeled with
this symbol on the packaging can be examined using an MR scan
under precisely defined conditions.
258
V Technical Data
Technical DataV365350-AEvia Function Manual
What's in this part? This part contains the following chapters:
Overview The technical data is documented in part V.
Chapter Chapter name Page
14 Parameters 259
15 Technical Data 272
259
14 Parameters
Parameters14365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Pacing Modes 260
Timing: Dual-chamber 261
Timing: Single-chamber 263
Pacing and sensing: Dual-chamber 264
Pacing and sensing: Single-chamber 266
Rate Adaptation 267
Preset Programs: Dual-chamber 268
Preset Programs: Single-chamber 269
Tolerances of Parameter Values 270
260 Parameters
Pacing Modes
Evia family The following pacing modes are available:
Device type Pacing mode Standard
DR(-T) DDD-CLS; VVI-CLS
DDDR; DDIR; DVIR; DOOR
VDDR; VDIR; VVIR; VVTR; VOOR
AAIR; AATR; AOOR
DDD; DDT; DDI; DVI; DOO
VDD; VDI; VVI; VVT; VOO
AAI; AAT; AOO
DDD-ADI; DDDR-ADIR
OFF
DDDR
SR(-T) VVI-CLS
VVIR; VVTR; VOOR
AAIR; AATR; AOOR
VVI; VVT; VOO
AAI; AAT; AOO
OFF
VVIR
Note: Home Monitoring is possible in all pacing modes.
261 Parameters
Timing: Dual-chamber
Basic rate day/night
Rate hysteresis
AV delay
AV hystereses
Ventricular pacing
suppression
Parameter Range of values Standard
Basic rate 30 ... (1) ... 88 ... (2) ... 122 ... (3) ... 140
... (5) ... 200 ppm
60 ppm
Night rate OFF
30 ... (1) ... 88 ... (2) ... 122 ... (3) ... 140
... (5) ... 200 ppm
OFF
Night begins 00:00 ... (10 min) ... 23:50 hh:mm 22:00 hh:mm
Night ends 00:00 ... (10 min) ... 23:50 hh:mm 06:00 hh:mm
Parameter Range of values Standard
Rate hysteresis OFF
-5 ... (-5) ... -90 ppm
OFF
Repetitive hysteresis OFF; 1 ... (1) ... 15 OFF
Scan hysteresis OFF; 1 ... (1) ... 15 OFF
Parameter Range of values Standard
AV delay Low; medium; high; fixed;
individual
Low
15 ... (5) ... 350 ms
(in 5 rate ranges)
180 ms
Sense compensation OFF
-10 ... (5) ... -120 ms
-45 ms
AV safety delay 100 ms 100 ms
Parameter Range of values Standard
AV hysteresis mode OFF
Negative, low; medium; high;
IRSplus
OFF
Positive repetitive
AV hysteresis
OFF
1 ... (1) ... 10
OFF
Negative repetitive
AV hysteresis
OFF
1 ... (1) ... 10 ... (5) ... 100 ... (10)
... 180
OFF
AV scan hysteresis OFF
1 ... (1) ... 10
OFF
Parameter Range of values Standard
V
p
suppression OFF; ON OFF
Pacing suppression after
consecutive V
s
1 ... (1) ... 8 6
Pacing supported after
X-out-of-8 cycles
1; 2; 3; 4 3
262 Parameters
Upper rate
Mode switching
Refractory periods
Blanking periods
PMT protection
Parameter Range of values Standard
Upper rate 90 ... (10) ... 200 ppm 130 ppm
Atrial upper rate OFF
240 ppm
240 ppm
Parameter Range of values Standard
Mode switching OFF; ON ON
Intervention rate 100 ... (10) ... 250 ppm 160 ppm
Switch to (mode) DDI; DDI(R) when permanent
DDD(R)
VDI; VDI(R) when permanent VDD(R)
DDI(R)
VDI(R)
Onset criterion 3 ... (1) ... 8 5
Resolution criterion 3 ... (1) ... 8 5
Change of the basic rate
with mode switching
OFF
+5 ... (5) ... +30 ppm
+10 ppm
Rate stabilization with
mode switching
OFF; ON OFF
Parameter Range of values Standard
Atrial refractory period AUTO AUTO
Atrial refractory period in
the modes AAI(R); AAT(R);
DDT
300 ... (25) ... 775 ms 350 ms
PVARP AUTO
175 ... (5) ... 600 ms
AUTO
PVARP after PVC PVARP + 150 ms (max: 600 ms) is
automatically programmed
400 ms
Ventricular refractory
period
200 ... (25) ... 500 ms 250 ms
Parameter Range of values Standard
Far-field protection after V
s
100 ... (10) ... 220 ms 100 ms
Far-field protection after V
p
100 ... (10) ... 220 ms 150 ms
Ventricular blanking after A
p
30 ... (5) ... 70 ms 30 ms
Parameter Range of values Standard
PMT detection/termination OFF; ON ON
VA criterion 250 ... (10) ... 500 ms 350 ms
263 Parameters
Timing: Single-chamber
Basic rate day/night
Rate hysteresis
Upper rate
Refractory period
Parameter Range of values Standard
Basic rate 30 ... (1) ... 88 ... (2) ... 122 ... (3)
... 140 ... (5) ... 200 ppm
60 ppm
Night rate OFF
30 ... (1) ... 88 ... (2) ... 122 ... (3)
... 140 ... (5) ... 200 ppm
OFF
Night begins 00:00 ... (10 min.)
... 23:50 hh:mm
22:00 hh:mm
Night ends 00:00 ... (10 min.)
... 23:50 hh:mm
06:00 hh:mm
Parameter Range of values Standard
Rate hysteresis OFF
-5 ... (-5) ... -90 ppm
OFF
Repetitive hysteresis OFF; 1 ... (1) ... 15 OFF
Scan hysteresis OFF; 1 ... (1) ... 15 OFF
Parameter Range of values Standard
Upper rate in VVT(R) mode 90 ... (10) ... 200 ppm 130 ppm
Parameter Range of values Standard
Refractory period 200 ... (25) ... 500 ms 250 ms
264 Parameters
Pacing and sensing: Dual-chamber
Pulse amplitude and
pulse width
Sensitivity
Atrial capture control
Ventricular capture control
Lead configuration
Parameter Range of values Standard
Pulse amplitude A 0.2 ... (0.1) ... 6.0 ... (0.5) ... 7.5 V 3.0 V
Pulse width A 0.1 ...(0.1) ... 0.5; 0.75; 1.0; 1.25;
1.5 ms
0.4 ms
Pulse amplitude V 0.2 ... (0.1) ... 6.0 ... (0.3) ... 7.5 V 3.0 V
Pulse width V 0.1 ... (0.1) 0.5; 0.75; 1.0; 1.25;
1.5 ms
0.4 ms
Parameter Range of values Standard
Sensitivity A AUTO
0.1 ... (0.1) ... 1.5 ... (0.5) ... 7.5 mV
AUTO
Sensitivity V AUTO
0.5 ... (0.5) ... 7.5 mV
AUTO
Parameter Range of values Standard
Atrial capture control ATM (monitoring only)
ON; OFF
ON
Min. amplitude 0.5 ... (0.1) ... 4.8 V 1.0 V
Threshold test start 2.4; 3.0; 3.6; 4.2; 4.8 V 3.0 V
Safety margin 0.5 ... (0.1) ... 1.2 V 1.0 V
Search type Interval; time of day Time of day
Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h
Time of day 00:00 ... (10 min) ... 23:50 02:00 hh:mm
Parameter Range of values Standard
Ventricular capture control ATM (monitoring only)
ON; OFF
ON
Min. amplitude 0.7 V 0.7 V
Threshold test start 2.4; 3.0; 3.6; 4.2; 4.8 V 3.0 V
Safety margin 0.3 ... (0.1) ... 1.2 V 0.5 V
Search type Interval; time of day Time of day
Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h
Time of day 00:00 ... (10 min) ... 23:50 02:00 hh:mm
Parameter Range of values Standard
Pacing polarity A Unipolar; bipolar Unipolar
Pacing polarity V Unipolar; bipolar Unipolar
Sensing polarity A Unipolar; bipolar Unipolar
Sensing polarity V Unipolar; bipolar Unipolar
265 Parameters
IEGM recordings
Rates for statistics
Parameter Range of values
IEGM recordings 20 (quantity); each max. 10 s
Types of IEGM recordings High atrial rate (HAR)
Mode switching
High ventricular rate (HVR)
Patient triggered (Pt.)
IEGM recording prior to event 0; 25; 50; 75; 100%
IEGM signal Filtered; unfiltered
Parameter Range of values Standard
High atrial rate
(HAR)
100 ... (5) ... 250 bpm
600; 572 ... 245; 240 ms
200 bpm
300 ms
High ventricular
rate (HVR)
150 ... (5) ... 200 bpm
400; 387 ... 308; 300 ms
180 bpm
333 ms
HVR counter 4; 8; 12; 16 8
266 Parameters
Pacing and sensing: Single-chamber
Pulse amplitude and
pulse width
Sensitivity
Ventricular capture control
Lead configuration
IEGM recordings
Rates for statistics
Parameter Range of values Standard
Pulse amplitude 0.2 ... (0.1) ... 6.0 ... (0.5) ... 7.5 V 3.0 V
Pulse width 0.1 ... (0.1) ... 0.5; 0.75; 1.0; 1.25;
1.5 ms
0.4 ms
Parameter Range of values Standard
Sensitivity AUTO
0.5 ... (0.5) ... 7.5 mV
AUTO
Parameter Range of values Standard
Ventricular capture
control
ATM (monitoring only)
ON; OFF
ON
Min. amplitude 0.7 V 0.7 V
Threshold test start 2.4; 3.0; 3.6; 4.2; 4.8 V 3.0 V
Safety margin 0.3 ... (0.1) ... 1.2 V 0.5 V
Search type Interval; time of day Time of day
Interval 0.1; 0.3; 1; 3; 6; 12; 24 h 24 h
Time of day 00:00 ... (10 min) ... 23:50 02:00 hh:mm
Parameter Range of values Standard
Pacing polarity Unipolar; bipolar Unipolar
Sensing polarity Unipolar; bipolar Unipolar
Parameter Range of values
IEGM recordings 20 (quantity); each max. 10 s
Types of IEGM recordings High atrial rate (HAR)
Mode switching
High ventricular rate (HVR)
Patient triggered (Pt.)
IEGM recording prior to event 0; 25; 50; 75; 100%
IEGM signal Filtered; unfiltered
Parameter Range of values Standard
High rate limit 150 ... (5) ... 200 bpm
400; 387 ... 308; 300 ms
180 bpm
333 ms
High rate counter 4; 8; 12; 16 8
267 Parameters
Rate Adaptation
Closed Loop Stimulation
rate adaptation
CLS modes:
Rate adaptation
via accelerometer
R modes:
Parameter Value range Standard
Max. CLS rate 80 ... (5) ... 160 ppm 120 ppm
CLS response Very low; low; medium; high;
very high
Medium
Resting rate control OFF;
+10 ... (10) ... +50 ppm
+20 ppm
CLS required Yes; no No
Parameter Range of values Standard
Sensor gain 1 ... 23 4
Max. activity rate 80 ... (5) ... 180 ppm 120 ppm
Automatic gain OFF; ON ON
Sensor threshold Very low; low; medium; high;
very high
Medium
Rate increase 1 ... (1) ... 10 ppm/cycle 4 ppm/cycle
Rate decrease 0.1; 0.2; 0.5; 1.0 ppm/cycle 0.5 ppm/
cycle
Rate fading OFF; ON OFF
268 Parameters
Preset Programs: Dual-chamber
Standard and safe program Only the auto-initialization function is activated as a factory setting.
All the other functions of the standard program are deactivated.
Parameter Standard
program
Safe
program
Mode (after auto initialization: DDD) DDDR VVI
Basic rate 60 ppm 70 ppm
Night program OFF OFF
Rate hysteresis OFF OFF
Upper rate 130 ppm
Dynamic AV delay Low
AV hysteresis OFF
Sense compensation 45 ms
AV safety delay 100 ms
Far-field protection after V
s
100 ms
Far-field protection after V
p
150 ms
Ventricular blanking period after A
p
30 ms
PMT protection ON
VA criterion 350 ms
Magnet response AUTO AUTO
Pulse amplitude A 3.0 V
Pulse amplitude V 3.0 V 4.8 V
Pulse width A 0.4 ms
Pulse width V 0.4 ms 1.0 ms
Sensitivity A AUTO
Sensitivity V AUTO 2.5 mV
Refractory period A AUTO
Refractory period V 250 ms 300 ms
Mode switching ON
Onset criterion 5-out-of 8
Resolution criterion 5-out-of 8
Intervention rate 160 ppm
Switches to DDIR
Basic rate with mode switching +10 ppm
Rate stabilization with mode switching OFF
2:1 lock-in protection ON
PVARP AUTO AUTO
PVARP after PVC 400 ms
269 Parameters
Preset Programs: Single-chamber
Standard and safe program Only the auto-initialization function is activated as a factory setting.
All the other functions of the standard program are deactivated.
Lead configuration, automatically determined and set:
Pacing polarity A/V Unipolar Unipolar
Sensing polarity A/V Unipolar Unipolar
Automatic lead check A/V ON ON
A/V capture control ON OFF
Atrial overdrive pacing OFF
V
p
suppression OFF
IEGM recording (HAR, HVR) ON OFF
Home Monitoring OFF OFF
Parameter Standard
program
Safe
program
Parameter Standard
program
Safe
program
Mode (after auto initialization: VVI) VVIR VVI
In the AAI mode, the safe program is
also AAI.
Basic rate 60 ppm 70 ppm
Night program OFF OFF
Rate hysteresis OFF OFF
Magnet response AUTO AUTO
Pulse amplitude 3.0 V 4.8 V
Pulse width 0.4 ms 1.0 ms
Sensitivity AUTO 2.5 mV
Refractory period 250 ms 300 ms
Lead configuration, automatically determined and set
Pacing polarity Unipolar Unipolar
Sensing polarity Unipolar Unipolar
Automatic lead check ON ON
Capture control ON OFF
IEGM recording ON OFF
Home Monitoring OFF OFF
270 Parameters
Tolerances of Parameter Values
Dual-chamber
Parameter Range of values Tolerance
Basic rate 30 ... 100 ppm +/-1.5 ppm
102 ... 195 ppm +/-2.0 ppm
200 ppm +0.0/-3.0 ppm
Basic interval 1000 ms +/-20 ms
Magnet rate 90 ppm +/-1.5 ppm
Magnet interval 664 ms +/-20 ms
AV delay 15 ... 350 ms +20/-5 ms
A/V pulse amplitude 0.2 V +/-0.10 V
0.3 ... 7.5 V +20/-25%
A/V pulse duration 0.1 ... 0.4 ms +/-0.04 ms
0.5 ... 1.0 ms +/-0.10 ms
1.25 ... 1.5 ms +/-0.15 ms
Sensitivity A
45502-2-1 triangle pulse
0.1 mV +0.2/-0.1 mV
0.2 ... 0.5 mV +/-0.1 mV
0.6 ... 7.5 mV +/-20%
Sensitivity V
45502-2-1 triangle pulse
0.5 mV +/-50%
1.0 ... 7.5 mV +/-20%
Refractory period A 300 ... 775 ms +10/-30 ms
Refractory period V 200 ... 500 ms +10/-30 ms
PVARP 175 ... 600 ms +10/-30 ms
PVARP after PVC 325 ... 600 ms +10/-30 ms
Max. activity rate 80 ... 100 ppm +/-1.5 ppm
105 ... 180 ppm +/-2.0 ppm
Upper rate 90 ... 190 ppm +/-2.0 ppm
200 ppm +0/-2.0 ppm
High rate protection 200 ppm +20/-0 ppm
Lead impedance 100 ... 200 Ohm +/-50 Ohm
201 ... 2500 Ohm +/-25%
271 Parameters
Single-chamber
Parameter Range of values Tolerance
Basic rate 30 ... 100 ppm +/-1.5 ppm
102 ... 195 ppm +/-2.0 ppm
200 ppm +0.0/-3.0 ppm
Basic interval 1000 ms +/-20 ms
Magnet rate 90 ppm +/-1.5 ppm
Magnet interval 664 ms +/-20 ms
Pulse amplitude 0.2 V +/-0.10 V
0.3 ... 7.5 V +20/-25%
Pulse width 0.1 ... 0.4 ms +/-0.04 ms
0.5 ... 1.0 ms +/-0.10 ms
1.25 ... 1.5 ms +/-0.15 ms
Sensitivity
45502-2-1 triangle pulse
0.5 mV +/-50%
1.0 ... 7.5 mV +/-20%
Refractory period 200 ... 500 ms +10/-30 ms
Max. activity rate 80 ... 100 ppm +/-1.5 ppm
105 ... 180 ppm +/-2.0 ppm
High rate protection 200 ppm +20/-0 ppm
Lead impedance 100 ... 200 Ohm +/-50 Ohm
201 ... 2500 Ohm +/-25%
272
15 Technical Data
Technical Data15365350-AEvia Function Manual
What's in this chapter? This chapter contains the following topics:
Topic Page
Mechanical Characteristics 273
Electrical Characteristics 274
Battery Data 276
Country-Related Information 278
Legend for the Label 279
273 Technical Data
Mechanical Characteristics
Measurements
for the housing
The measurements refer to the housing without header.
Radiopaque marker BIO SF
Materials in contact
with body tissue
Housing: titanium
Header: epoxy resin
Sealing plug: silicone
Coating, if applicable: silicone
Device W x H x D [mm] Volume [cm
3
] Mass [g]
DR-T 53 x 44.5 x 6.5 12 25
DR 53 x 43 x 6.5 11 26
SR-T 53 x 39 x 6.5 11 24
SR 53 x 39 x 6.5 10 25
274 Technical Data
Electrical Characteristics
Components and input
values
Electrical characteristics determined at 37C, 500 Ohm
Housing shape The device housing has the following shape:
Electrically conductive
surface
The device housing has the following surface:
Pulse form The pacing pulse has the following form:
The pulse amplitude reaches its maximum value at the beginning of the pulse (Ua).
With increasing pacing duration (tb), the pulse amplitude is reduced dependent on
the pacing impedance.
Resistance to interference All variants of BIOTRONIK devices comply with the requirements of
prEN 45502-2-1: 2006, Section 27.5.1 at the highest sensitivity.
Circuit Hybrid electronics with
VLSI-CMOS chip
Input impedance > 10 kOhm
Pulse form Biphasic, asymmetric
Polarity Cathodic
Device type Dual-chamber, single-chamber
Uncoated Flattened ellipsoid
Coated
Device type Dual-chamber, single-chamber
Uncoated [cm
2
]
33
Coated [cm
2
]
7
275 Technical Data
Temperature stability Measurements were made at 20, 30 and 45C and a load resistance of 500 Ohms.
Telemetry Telemetry data for Home Monitoring:
Sensitivity: 1 mV in A, 2.5 mV in V; capture control: OFF
Pulse amplitude: 3 V in A and V
Pulse width: 0.4 ms in A and V
Basic rate: 60 ppm; magnet rate (setpoint): 90 ppm
20 30 45 [C]
0
1
2
[mV]
0,96
2,56
A
V
20 30 45 [C]
2
3
[V]
2,8
A, V
20 30 45 [C]
0,3
0,4
[ms]
0,39
A, V
20 30 45 [C]
60
90
[ppm]
90,63
60,12
Nominal carrier frequency Maximum power of transmission
403.62 MHz < 25 W
-16 dBm
276 Technical Data
Battery Data
Battery type characteristics The following data is entered by the manufacturer:
Power consumption The device has the following power consumption:
Average service time Average service times are precalculated using the battery manufacturer's technical
specifications, a basic rate of 60 ppm and the setting of different pulse amplitudes
and lead impedances.
Service times
dual-chamber
For dual-chamber devices, the following times (in years) result:
Manufacturer GREATBATCH, INC.
Clarence, NY 14031, USA
LITRONIK GmbH
01796 Pirna, Germany
Battery type GB 8431 GB 2596 LiS 3150 LiS 3150M
System LiJ Ag/SVO/CFx
QMR


LiJ LiMn0
2
Device type DR
SR
DR-T
SR-T
DR
SR
DR-T
SR-T
Battery voltage
at BOS
2.8 V 3.0 V 2.8 V 3.1 V
Open-circuit
voltage
2.8 V 3.0 V 2.8 V 3.1 V
Nominal capacity 1.3 Ah 1.3 Ah 1.3 Ah 1.2 Ah
Usable capacity
until EOS
1.2 Ah 1.1 Ah 1.2 Ah 1.0 Ah
Power consumption Dual-chamber Single-chamber
BOS, inhibited 6 A 6 A
BOS, 100% pacing 13 A 9 A
Amplitude Impedance
[Ohms]
Pacing
10% 50% 100%
DR-T DR DR-T DR DR-T DR
1.5 V 500 >15 >15 14.3 14.8 12.7 13.0
1000 >15 >15 >15 >15 14.2 14.7
2.5 V 500 13.4 13.6 12.0 12.1 9.5 9.4
1000 14.7 >15 13.7 14.1 11.8 12.0
3.0 V 500 12.2 12.1 10.3 10.2 7.6 7.3
1000 13.8 14.2 12.4 12.7 10.0 10.1
3.5 V 500 11.3 11.1 9.3 9.0 6.5 6.2
1000 13.1 13.4 11.6 11.7 8.9 8.9
5.0 V 500 7.1 7.8 5.2 5.8 3.2 3.6
1000 9.6 10.7 7.5 8.7 4.9 5.9
277 Technical Data
Service times
single-chamber
For single-chamber devices, the following times (in years) result:
Shortening of
the service time
after long storage period
Depending on the storage period, the service time from the beginning of service
BOS to the replacement time ERI decreases as follows:
After 1 year:
Dual-chamber by 6 months
Single-chamber by 8 months
After 1.5 years:
Dual-chamber by 9 months
Single-chamber by 12 months
Amplitude Impedance
[Ohms]
Pacing
10% 50% 100%
SR-T SR SR-T SR SR-T SR
1.5 V 500 >15 >15 >15 >15 >15 >15
1000 >15 >15 >15 >15 >15 >15
2.5 V 500 >15 >15 >15 >15 13.4 13.3
1000 >15 >15 >15 >15 >15 >15
3.0 V 500 >15 >15 14.3 14.2 11.3 11.2
1000 >15 >15 >15 >15 13.9 14.1
3.5 V 500 >15 14.9 13.2 12.9 10.1 9.7
1000 >15 >15 >15 >15 12.8 12.9
5.0 V 500 10.8 11.3 8.4 9.1 5.4 6.2
1000 13.4 14.5 11.3 12.5 8.0 9.4
278 Technical Data
Country-Related Information
International certification Other notes specific to each country will follow in the course of international
product certification.
Industry Canada Telemetry data
This device may not interfere with stations operating in the rate range of
400.150 - 406.000 MHz in the meteorological aids, meteorological-satellite, and
earth exploration-satellite services and must accept any interference received,
including interference that may cause undesired operation.
This device will be registered with Industry Canada under the following number:
IC: 4708A-PRIMUS
The code IC in front of the certification/ registration number only indicates that
the technical requirements for Industry Canada are met.
China The following provides information according to the ordinance
no. 39 issued by the 'Ministry for Industry and Information
Technology' of the People's Republic of China pertaining to the
materials which are contained in BIOTRONIK's pacemakers,
ICDs and external devices:
Dangerous material In PCBs In cables
Lead Pb Yes (soldering agent) Yes
Mercury Hg No No
Cadmium Cd No No
Chrome compounds Cr6+ No No
Polybrominated biphenyls PBB No No
Polybrominated diphenyl ether PBDE No No
25
279 Technical Data
Legend for the Label
The label icons symbolize the following:
Manufacturing date
Use by
Storage temperature
BIOTRONIK order number
Serial number
Product identification number
Sterilization with ethylene oxide
Resterilization prohibited
Not for reuse
Non-sterile
Usage information
Contents
Do not use if packaging is damaged.
European approval mark
Non-ionizing radiation
STERILIZE
2
NON
STERILE
280 Technical Data
Transfer sheath for leads with PIN-lock PE lead
connector (5 mm) to connect to pacemakers with
PEC sockets (6 mm)
Device with NBG encoding and name of compatible
leads (example)
Silicone-coated device with NBG encoding and
designation of the compatible leads (example)
Screwdriver
Position of connector ports in the header (example)
Unipolar IS-1 connector
Bipolar IS-1 connector
A Atrium
V Ventricle
UNI/BI Unipolar/bipolar configuration
V
p
V
s
Ventricular pace
Ventricular sense
A
p
A
s
Atrial pace
Atrial sense
MR conditional
Patients who have a pacing system with devices
having this symbol indicated on the packaging,
can undergo an MR scan under precisely defined
conditions.
DDDR
A
IS-1
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