Medtronic C60A3U Reference Guide
C-series
C60 DR
C20 SR
C-series VSF12 1.2 (Vitatron CareLink)
C60A3
C20A3
Reference Manual
Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
C-series Reference Manual
Contents
Part I General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.1 About this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.2 Programming instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2 The pacemaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 Vitatron C60 DR (Model C60A3) . . . . . . . . . . . . . . . . . . . . . 9
2.3 Vitatron C20 SR (Model C20A3) . . . . . . . . . . . . . . . . . . . . 10
2.4 Connector configuration . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3 The patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.4 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.5 Pacing code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.6 Mode selection decision tree . . . . . . . . . . . . . . . . . . . . . . . 13
3.7 Mode descriptions, indications and contraindications by
mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4 The programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.2 How to start a programmer session . . . . . . . . . . . . . . . . . 24
4.3 How to use the cardiac dashboard . . . . . . . . . . . . . . . . . . 26
4.4 How to view pacemaker diagnostics . . . . . . . . . . . . . . . . . 31
4.5 How to program parameters . . . . . . . . . . . . . . . . . . . . . . . 32
4.6 How to start tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.7 How to enter patient information . . . . . . . . . . . . . . . . . . . . 38
4.8 How to save and reload data . . . . . . . . . . . . . . . . . . . . . . . 40
4.9 How to print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
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C-series Reference Manual
4.10 How to adjust the programmer . . . . . . . . . . . . . . . . . . . . . 48
4.11 How to adjust the ECG window . . . . . . . . . . . . . . . . . . . . . 50
4.12 Emergency programming . . . . . . . . . . . . . . . . . . . . . . . . . 59
Part II Follow-up and diagnostics . . . . . . . . . . . . . . . . . . . . . . 61
5 Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.2 Post-implant configuration . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.3 Record an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.4 Program patient information . . . . . . . . . . . . . . . . . . . . . . . 63
5.5 Checks and programming . . . . . . . . . . . . . . . . . . . . . . . . . 63
5.6 Optimizing the pacemaker . . . . . . . . . . . . . . . . . . . . . . . . . 65
5.7 The ECG/EGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
5.8 Follow-up frequency and longevity . . . . . . . . . . . . . . . . . . 66
6 Optimizing pacing and sensing . . . . . . . . . . . . . . . . . . . . . . . 73
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
6.2 Optimizing pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
6.3 Optimizing sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
6.4 Lead measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
6.5 VA interval measurement . . . . . . . . . . . . . . . . . . . . . . . . . 88
6.6 Temporary test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
6.7 Atrial burst pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
6.8 Tests history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
7 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
7.2 Therapy Advisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
7.3 Data collection and storage periods . . . . . . . . . . . . . . . . 101
7.4 Displaying diagnostic data . . . . . . . . . . . . . . . . . . . . . . . . 102
7.5 Assessing atrial rhythm and AF . . . . . . . . . . . . . . . . . . . . 110
7.6 Assessing ventricular rhythm . . . . . . . . . . . . . . . . . . . . . . 114
7.7 Assessing AV synchrony . . . . . . . . . . . . . . . . . . . . . . . . . 120
7.8 Assessing rate response . . . . . . . . . . . . . . . . . . . . . . . . . 120
7.9 Assessing sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
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8 Selected Episodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
8.2 Data collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
8.3 Setting up episode selection . . . . . . . . . . . . . . . . . . . . . . 131
8.4 Selected Episodes overview . . . . . . . . . . . . . . . . . . . . . . 135
8.5 Selected Episodes histograms . . . . . . . . . . . . . . . . . . . . 136
8.6 Selected Episodes diary . . . . . . . . . . . . . . . . . . . . . . . . . 137
8.7 Selected Episodes stored EGM . . . . . . . . . . . . . . . . . . . 139
Part III Pacing therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
9 An introduction to Vitatron pacing therapies . . . . . . . . . . . 141
9.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
9.2 Basic pacing therapies . . . . . . . . . . . . . . . . . . . . . . . . . . 142
9.3 Pacemaker timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
9.4 Lower rate pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
9.5 Maximum rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
9.6 Refractory period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
9.7 Blanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
9.8 Ventricular safety pacing (VSP) . . . . . . . . . . . . . . . . . . . . 152
9.9 Atrial hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
9.10 Interference management . . . . . . . . . . . . . . . . . . . . . . . . 158
10 Rate stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
10.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
10.2 Atrial rhythm classification . . . . . . . . . . . . . . . . . . . . . . . . 159
10.3 Atrial tracking behavior . . . . . . . . . . . . . . . . . . . . . . . . . . 161
10.4 Bradyarrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
10.5 Atrial tachyarrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
10.6 Rate stabilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
11 AV synchrony . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
11.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
11.2 Paced and sensed AV delay . . . . . . . . . . . . . . . . . . . . . . 174
11.3 Adaptive AV delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
11.4 Refined Ventricular Pacing (RVP) . . . . . . . . . . . . . . . . . . 177
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C-series Reference Manual
11.5 Atrial synchronization pace (ASP) interval . . . . . . . . . . . 179
11.6 Retrograde conduction and PVC management . . . . . . . . 180
12 Rate response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
12.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
12.2 Activity sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
12.3 Slope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
12.4 Daily learning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
12.5 Fast learning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
12.6 Activity acceleration and deceleration . . . . . . . . . . . . . . . 193
Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
A Safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
A.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
A.2 Pacemaker restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
B Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
B.1 Effects of extreme conditions . . . . . . . . . . . . . . . . . . . . . 199
B.2 Area restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
B.3 Environmental and medical therapy hazards . . . . . . . . . 199
C Product specifications Vitatron C60 DR, ............................. 205
C.1 Programming parameters . . . . . . . . . . . . . . . . . . . . . . . . 205
C.2 Technical parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
D Product specifications Vitatron C20 SR .............................. 213
D.1 Programming parameters . . . . . . . . . . . . . . . . . . . . . . . . 213
D.2 Technical parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
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C-series Reference Manual
Part I
General information
1 Introduction
1.1 About this manual
This Reference Manual contains an extensive description of the Vitatron C-series of
pacemakers (Vitatron C60 DR and Vitatron C20 SR).
For ease of use, the manual is divided into three parts.
In Part I, general information is given about the Vitatron pacing system. It begins with an
introduction to the manual (see Chapter 1), and a description of each pacemaker (see
Chapter 2). This is followed by a description of each available pacing mode, together
with the relevant indications and contraindications (see Chapter 3). How to carry
out common programming procedures and program the programmer preferences are
described in Chapter 4.
In Part II, follow-up and diagnostic features are discussed. Basic follow-up procedures
are described in Chapter 5. This is followed by a more detailed description of how to
optimize pacing and sensing characteristics (see Chapter 6). Advice on how to make
optimal use of the diagnostic features included in the pacemakers is given in Chapter 7.
The Selected Episodes diagnostic feature is explained in Chapter 8.
In Part III, there is an extensive description of the pacing therapies. The basic pacing
therapies, including timing characteristics are described in Chapter 9. This is followed by
advice on maintaining rate stability (see Chapter 10), the importance of maintaining and
restoring AV synchrony (see Chapter 11) and rate response (see Chapter 12).
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C-series Reference Manual Section 1.1
The appendices provide technical information. Safety features are described in
Appendix A and precautions are listed in Appendix B. In Appendix C and Appendix D
the programmable parameters of each individual pacemaker and their most important
specifications are listed.
1.2 Programming instructions
The gray block at the beginning of some sections contains instructions for programming
the parameter. For example:
Parameters
⇒ Therapies
⇒ Lower Rate…
⇒ Night Lower Rate
Range: 40 - (5) - 130 min
Availability: All modes, except OOO
The first line contains the name of the icon in the control panel (see Section 4.3). You
can press the tab or value boxes named on the following lines to program the parameter.
–1
The “Range” usually shows the lowest and highest values that you can program. The
number in brackets shows the programming steps within this range. In some cases you
can choose an option, for example “On” or “Off”.
The “Availability” line lists any restrictions on the use of the parameter, for example, in
which modes it is available.
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C-series Reference Manual
2 The pacemaker
2.1 Introduction
The Vitatron C-series consists of a dual chamber pacemaker model (Vitatron C60 DR)
and a single chamber pacemaker model (Vitatron C20 SR).
These pacemakers provide an extensive range of therapies for the treatment of
bradycardia. Ventricular Rate Stabilization is specially designed to reduce ventricular
irregularity.
Diagnostic tools quickly provide information about the effectiveness of pacemaker therapy
and simplify follow-up sessions. Detailed information and intracardiac electrograms
(EGMs), recorded during selected episodes of high rates, are stored for interrogation at
the next follow-up session. Storage of EGMs has a negligible effect on the pacemaker
longevity.
Therapy Advisor automatically scans pacemaker data at the start of a follow-up session
(battery status, diagnostic data and programmed parameters). It immediately reports any
important events, including AF, and gives suggestions for programming the pacemaker.
2.2 Vitatron C60 DR (Model C60A3)
The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing
using an accelerometer) for permanent atrial and ventricular pacing. It has the following
features:
Ventricular Rate Stabilization (VRS), to regulate the ventricular rate during episodes
•
of conducted atrial tachyarrhythmia
Refined Atrial Pacing (RAP) and Refined Ventricular Pacing (RVP), to give further
•
preference to intrinsic atrial depolarization and conduction
Beat-to-Beat mode switching enables the pacemaker to detect atrial arrhythmias
•
and respond immediately to them
Therapy Advisor, which provides clear and concise advice on pacemaker settings
•
and therapies
Selected Episodes with stored EGMs, which provides detailed information about
•
episodes of high rates
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C-series Reference Manual Section 2.3
2.3 Vitatron C20 SR (Model C20A3)
The Vitatron C20 SR is a single chamber rate responsive pacemaker (activity sensing
using an accelerometer) for permanent atrial or ventricular pacing. It has the following
features:
Ventricular Rate Stabilization (VRS), to stabilize the ventricular rate during episodes
•
of irregularity which are probably due to conducted atrial tachyarrhythmia (VVI(R)
mode only)
Therapy Advisor, which provides clear and concise advice on pacemaker settings
•
and therapies
Selected Episodes with stored EGMs, which provides detailed information about
•
episodes of high rates
2.4 Connector configuration
Vitatron digital pacemakers all have IS-1 connectors. Access to the connector screws is
from above for single chamber pacemakers and from the engraved side for dual chamber
pacemakers (see Figure 1).
Figure 1. Connector configuration
1 Dual chamber connection
2 Single chamber connection
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C-series Reference Manual
3 The patient
3.1 Introduction
Cardiac pacing is an accepted method of controlling heart rate in patients with
symptomatic bradyarrhythmias. Vitatron pacemakers are therefore intended for use in
patients for whom permanent cardiac pacing is indicated for the treatment of disorders in
impulse formation or conduction.
This chapter describes specific indications and contraindications, together with a
description of each of the available pacing modes.
3.2 Indications
Dual chamber pacing is indicated if AV synchrony needs to be restored to optimize cardiac
output (for example, in patients with symptomatic second or third degree AV block).
Dual chamber rate responsive pacing modes are of specific benefit to patients with
chronotropic incompetence of the sinus node.
Rate responsive modes can help patients who have a requirement for an increase in
pacing rate, in response to physical activity.
Single chamber ventricular pacing can help patients with permanent atrial
tachyarrhythmias, including atrial fibrillation and flutter.
Single chamber atrial pacing can help patients with symptomatic bradyarrhythmias and
normal AV conduction.
3.3 Contraindications
There are no known contraindications to the use of pacemakers as a means to control
the heart rate. The patient’s individual medical condition dictates which particular pacing
system and mode of operation is chosen by the physician.
Pacemakers are contraindicated in the following situations:
dual chamber
•
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C-series Reference Manual Section 3.3
– permanent supraventricular tachyarrhythmias, including atrial fibrillation and
flutter
– expected aggravation of clinical symptoms (for example, angina pectoris) or
congestive heart failure caused by fast heart rates
– inadequate intracavitary atrial complexes
single chamber AAI(R)
•
– AV conduction disturbances
– inadequate intracavitary atrial complexes
single chamber VVI(R)
•
– known pacemaker syndrome
– a need for AV synchrony
– expected aggravation of clinical symptoms (for example angina pectoris) or
congestive heart failure caused by fast heart rates
3.4 Potential adverse events
Adverse events associated with pacemaker systems include: cardiac perforation, cardiac
tamponade, death, erosion through the skin, hematoma/seroma, infection, improper
operation caused by theft-prevention systems, myopotential sensing, nerve stimulation,
muscle stimulation, pacemaker syndrome, rejection phenomena (local tissue reaction,
fibrotic tissue formation, pacemaker migration), threshold elevation, and transvenous
lead-related thrombosis.
3.5 Pacing code
Pacemaker modes are described using the NBG code. The five-letter NBG1code,
named after The North American Society of Pacing and Electrophysiology (NASPE)
and the British Pacing and Electrophysiology Group (BPEG), describes the operation
of implantable pulse generators. The NBG code, which supersedes the ICHD Code,
is described in Table 1.
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C-series Reference Manual Section 3.5
Permanent Atrial
Fibrillation/Flutter?
Sinus Node Dysfunction
VVIR
AV Block AV Block
Paroxysmal Atrial
Fibrillation/Flutter?
DDDR + MS DDD(R) AAI(R)
Y N
Paroxysmal Atrial
Fibrillation/Flutter?
DDDR + MS DDD/VDD
Y N
Y N
Y
AV Block
Y N
Y
Y
Table 1. The Revised NASPE/BPEG Generic Code for Antibradycardia Pacing
Position: I II III IV V
Category: Chamber(s)
Paced
O = None
A = Atrium
V = Ventricle
D = Dual
(A + V)
Manufacturers’
designation
S = Single
(A or V)
Chamber(s)
Sensed
O = None
A = Atrium
V = Ventricle
D = Dual
(A + V)
S = Single
(A or V)
Response to
Sensing
O = None
T = Triggered
I = Inhibited
D = Dual
(T + I)
Rate
Modulation
O = None
R = Rate
modulation
Multisite
Pacing
O = None
A = Atrium
V = Ventricle
D = Dual
(A + V)
only:
Note: The programmer displays A or V (not S) for chambers paced and sensed.
3.6 Mode selection decision tree
The following basic decision tree is an aid in selecting the best pacing mode for a
particular patient.
Figure 2. Basic decision tree (from den Dulk, K et al. Selection of the optimal pacing mode. The
Netherlands Journal of Cardiology 1992; 5:214-225)
1
Bernstein A.D, et al., The Revised NASPE/BPEG Pulse Generator Code, Pace, 25, No 2, Feb 2002.
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C-series Reference Manual Section 3.7
3.7 Mode descriptions, indications and contraindications by mode
3.7.1 DDDR mode
The pacemaker senses and paces in both the atrium and the ventricle. Sensed atrial
events inhibit the atrial channel and start an AV delay. Sensed atrial events conducted to
the ventricles before the end of the AV delay inhibit the ventricular channel. Sensed atrial
events not conducted before the end of the AV delay trigger the release of a ventricular
stimulus (tracking of the atrial rate).
Paced atrial events also start an AV delay. Paced atrial events conducted to the ventricles
before the end of the AV delay inhibit the ventricular channel. Paced atrial events not
conducted before the end of the AV delay trigger the release of a ventricular stimulus.
In the absence of sinus rhythm and spontaneous AV conduction, both chambers are
paced at the sensor rate, the Flywheel rate, or the lower rate (whichever is highest).
In the presence of atrial tachyarrhythmias, Beat-to-Beat mode switching is initiated (the
ventricular rate is stabilized by rate responsive ventricular pacing). The atrial rate is
monitored on a beat to beat basis and AV synchronous pacing is restored as soon as
possible.
Indications:
chronotropic incompetence due to atrial bradyarrhythmia or AV block
•
sick sinus syndrome, including brady-tachy syndrome
•
paroxysmal atrial arrhythmias in patients who require restoration of AV synchrony
•
Contraindications:
permanent atrial tachyarrhythmias, including atrial fibrillation and flutter
•
expected aggravation of clinical symptoms (for example angina pectoris) or
•
congestive heart failure caused by fast heart rates
3.7.2 DDD mode
The pacemaker senses and paces in both the atrium and the ventricle. Sensed atrial
events inhibit the atrial channel and start an AV delay. Sensed atrial events conducted to
the ventricles before the end of the AV delay inhibit the ventricular channel. Sensed atrial
events not conducted before the end of the AV delay trigger the release of a ventricular
stimulus (tracking of the atrial rate).
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C-series Reference Manual Section 3.7
Paced atrial events also start an AV delay. Paced atrial events conducted to the ventricles
before the end of the AV delay inhibit the ventricular channel. Paced atrial events not
conducted before the end of the AV delay trigger the release of a ventricular stimulus.
In the absence of sinus rhythm and spontaneous AV conduction both chambers are
paced either at the Flywheel rate or the lower rate (whichever is highest).
In the presence of atrial tachyarrhythmias, Beat-to-Beat mode switching is initiated. The
atrial rate is monitored on a beat to beat basis and AV synchronous pacing is restored as
soon as possible.
Indications:
intermittent or complete AV block with normal sinus rhythm
•
sick sinus syndrome, including brady-tachy syndrome
•
paroxysmal atrial arrhythmias in patients who require restoration of AV synchrony
•
Contraindications:
permanent atrial arrhythmias, including atrial fibrillation and flutter
•
expected aggravation of clinical symptoms (for example angina pectoris) or
•
congestive heart failure caused by fast heart rates
3.7.3 DDIR mode
The pacemaker senses and paces in both the atrium and the ventricle. Atrial inhibition
does not trigger an AV delay. In the absence of spontaneous conduction to the ventricle
the pacemaker actively resynchronizes the atrium with the ventricle using an atrial
synchronization pace (ASP). The pacing rate is dictated by the sensor rate.
Indications:
atrial bradyarrhythmia in patients with paroxysmal atrial tachyarrhythmias, with or
•
without normal AV conduction
brady-tachy syndrome
•
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C-series Reference Manual Section 3.7
Contraindications
complete AV block with normal sinus rhythm (allows retrograde P-wave sensing or
•
continuous atrial synchronization pacing)
3.7.4 DDI mode
The pacemaker senses and paces in both the atrium and the ventricle. Atrial inhibition
does not trigger an AV delay. In the absence of spontaneous conduction to the ventricle
the pacemaker actively resynchronizes the atrium with the ventricle using an atrial
synchronization pace (ASP). The pacing rate is dictated by the programmed lower rate.
Indications:
atrial bradyarrhythmia in patients with paroxysmal atrial tachyarrhythmias, with or
•
without normal AV conduction
brady-tachy syndrome
•
Contraindications
complete AV block with normal sinus rhythm (allows retrograde P-wave sensing or
•
continuous atrial synchronization pacing)
3.7.5 DOO mode
The pacemaker provides asynchronous, AV sequential pacing at the programmed lower
rate.
Indications:
intended primarily as a temporary mode to reduce the likelihood of triggering or
•
inhibition during electrosurgery or electromagnetic interference
Contraindications:
intrinsic cardiac activity at a rate sufficient to cause competitive pacing
•
3.7.6 VDDR mode
The pacemaker senses in both the atrium and the ventricle but can only pace the
ventricle. It tracks spontaneous sinus rhythm and is inhibited by ventricular sensing.
In the absence of sinus rhythm, or in the presence of atrial tachyarrhythmias, rate
responsive ventricular pacing is initiated.
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C-series Reference Manual Section 3.7
Indications:
intermittent or complete AV block with normal sinus rhythm, with or without
•
paroxysmal atrial tachyarrhythmia
Contraindications:
likelihood of loss of AV synchrony (atrial bradyarrhythmia) and associated
•
complications (retrograde conduction, anticipated or known pacemaker syndrome)
permanent atrial tachyarrhythmias, including atrial fibrillation and flutter
•
expected aggravation of clinical symptoms (for example angina pectoris) or
•
congestive heart failure caused by fast heart rates
inadequate intracavitary atrial complexes
•
3.7.7 VDD mode
The pacemaker senses in both the atrium and the ventricle but can only pace the
ventricle. It tracks spontaneous sinus rhythm and is inhibited by ventricular sensing. In
the absence of sinus rhythm, or in the presence of atrial tachyarrhythmias, ventricular
(VVI) pacing at the programmed lower rate is initiated.
Indications:
intermittent or complete AV block with normal sinus rhythm, with or without
•
paroxysmal atrial tachyarrhythmia
Contraindications:
likelihood of loss of AV synchrony (atrial bradyarrhythmia) and associated
•
complications (retrograde conduction, anticipated or known pacemaker syndrome)
permanent atrial tachyarrhythmias, including atrial fibrillation and flutter
•
inadequate intracavitary atrial complexes
•
3.7.8 VVIR mode
The pacemaker senses and paces in the ventricle and is inhibited by sensed ventricular
events. In the absence of spontaneous ventricular rhythm, rate responsive ventricular
pacing is initiated.
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C-series Reference Manual Section 3.7
Indications:
permanent atrial fibrillation and flutter with symptomatic ventricular bradyarrhythmia
•
Contraindications:
expected aggravation of clinical symptoms (for example angina pectoris) or
•
congestive heart failure caused by fast heart rates
anticipated or known pacemaker syndrome
•
a need for the restoration of AV synchrony
•
3.7.9 VVI mode
The pacemaker senses and paces in the ventricle and is inhibited by sensed ventricular
events. In the absence of spontaneous ventricular rhythm, ventricular pacing at the
programmed lower pacing rate is initiated.
Indications:
permanent atrial fibrillation and flutter with symptomatic ventricular bradyarrhythmia
•
Contraindications:
anticipated or known pacemaker syndrome
•
a need for the restoration of AV synchrony
•
3.7.10 VVT mode
The pacemaker paces and senses in the ventricle. Operation is identical to the VVI mode
except that events sensed during the ventricular escape interval trigger an immediate
pacing pulse.
Indications:
intended as a temporary diagnostic mode, used to verify sensing and evaluate
•
arrhythmias. This mode may also be useful in preventing inappropriate inhibition in
the presence of electromagnetic interference.
Contraindications:
anticipated or known pacemaker syndrome
•
a need for the restoration of AV synchrony
•
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C-series Reference Manual Section 3.7
3.7.11 VOO mode
The pacemaker paces in the ventricle at the programmed lower rate (asynchronous
ventricular pacing). It is not inhibited by sensed ventricular events.
Indications:
intended primarily as a temporary mode to reduce the likelihood of triggering or
•
inhibition during electrosurgery or electromagnetic interference
Contraindications:
intrinsic cardiac activity at a rate sufficient to cause competitive pacing
•
3.7.12 AAIR mode
The pacemaker senses and paces in the atrium and is inhibited by sensed atrial events.
In the absence of spontaneous rhythm, rate responsive atrial pacing is initiated.
Indications:
atrial bradyarrhythmia with normal AV conduction
•
Contraindications:
AV conduction disturbances
•
atrial fibrillation and flutter
•
expected aggravation of clinical symptoms (for example angina pectoris) or
•
congestive heart failure caused by fast heart rates
inadequate intracavitary atrial complexes
•
3.7.13 AAI mode
The pacemaker senses and paces in the atrium and is inhibited by sensed atrial events.
In the absence of spontaneous atrial rhythm, atrial pacing at the programmed rate is
initiated.
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C-series Reference Manual Section 3.7
Indications:
atrial bradyarrhythmia with normal AV conduction
•
Contraindications:
AV conduction disturbances
•
atrial fibrillation and flutter
•
inadequate intracavitary atrial complexes
•
3.7.14 AAT mode
The pacemaker paces and senses in the atrium. Operation is identical to the AAI mode
except that events sensed during the atrial escape interval trigger an immediate pacing
pulse.
Indications:
intended as a temporary diagnostic mode, used to verify sensing and evaluate
•
arrhythmias. This mode may also be useful in preventing inappropriate inhibition in
the presence of electromagnetic interference.
Contraindications:
inadequate intracavitary atrial complexes
•
3.7.15 AOO mode
The pacemaker paces in the atrium at the programmed lower rate (asynchronous atrial
pacing). It is not inhibited by sensed atrial events.
Indications:
intended primarily as a temporary mode to reduce the likelihood of triggering or
•
inhibition during electrosurgery or electromagnetic interference
Contraindications:
intrinsic cardiac activity at a rate sufficient to cause competitive pacing
•
AV conduction disturbances
•
3.7.16 OOO mode
In the OOO mode pacing is switched off.
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C-series Reference Manual Section 3.7
Indications:
used for diagnostic purposes, such as the analysis of underlying rhythm
•
Contraindications:
patients with no underlying rhythm
•
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C-series Reference Manual
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C-series Reference Manual
4 The programmer
4.1 Introduction
Vitatron C-series pacemakers can be programmed with a Vitatron CareLink programmer
with Vitatron C-series software. This manual only describes the software for the Vitatron
C-series. For specific programmer information, please refer to the programmer manual
which is provided with the programmer.
This chapter describes how to carry out a follow-up session using the programmer.
how to start a programmer session (see Section 4.2)
•
how to use the cardiac dashboard (see Section 4.3)
•
how to view diagnostics (see Section 4.4)
•
how to program parameters (see Section 4.5)
•
how to start tests (see Section 4.6)
•
how to enter patient information (see Section 4.7)
•
how to save and reload data (see Section 4.8)
•
how to print and set print options (see Section 4.9)
•
Two sections describe how to change the programmer settings and display.
how to adjust the programmer (see Section 4.10)
•
how to adjust the ECG display (see Section 4.11)
•
The last section explains how to perform emergency programming (see Section 4.12).
Notes:
Programmers other than the Vitatron CareLink are not compatible.
•
When using a second programmer during the same follow-up session, the first
•
session must be ended before the second begins.
The screens in this chapter show examples based on dual chamber pacemakers,
•
and are subject to minor changes. The screens for single chamber pacemakers
have a simpler layout because many features are not applicable to all models.
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C-series Reference Manual Section 4.1
Warning: Pacemaker programming should be done only after careful study of
the Pacemaker Manual and after determination of the appropriate parameter
settings. Improper use of the programmer could result in erroneous or inadvertent
programming and improper operation of the telemetry and measurement functions.
4.2 How to start a programmer session
After switching the programmer on the Vitatron desktop appears.
Figure 3. The Vitatron desktop
The main parts of the desktop are described briefly in this section. The task bar, which
appears above the top line, is described in the programmer manual.
1 Top line – The desktop always shows the Vitatron logo on the top line. During a
follow-up session, the patient’s name, the pacemaker model name and number are also
shown. The top line is not usually included in the illustrations used in this manual.
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C-series Reference Manual Section 4.2
2 ECG window and controls – While the desktop is active, the ECG window displays
the default surface electrocardiogram (ECG lead I, II or III). During a follow-up session,
the filtered atrial and ventricular intracardiac electrograms (AEGM and VEGM), marker
annotations and marker intervals are also available. For a description of this window,
see Section 4.3.1.
The ECG controls on the right allow you to freeze the ECG, adjust the ECG settings
and ECG markers or recall previously stored ECGs. For a detailed explanation see
Section 4.11.
For instructions on connecting the ECG cable and leads, refer to the programmer manual.
3 Control panel – Pressing one of the control panel icons opens the relevant window in
the main window.
4 Main window – At startup the main window always contains the Select Model window.
During a follow-up session, the main window contains the cardiac dashboard or one
of the detailed windows.
5 Button line – When the desktop is active, the bottom line contains the [Auto Identify]
button and a Vitatron to Medtronic switch, which is used to go from Vitatron to Medtronic
applications and vice versa. During a follow-up or demonstration session, the bottom
line contains buttons that are available in all windows. On some buttons, three dots
indicate that pressing the button opens another window in which you can program
related parameters.
4.2.1 Starting a demo session
Select a model from the Select Model window and press [Demo] to start a simulated
programming session.
4.2.2 Starting a follow-up session
To start automatic pacemaker recognition position the programming head and press
[Auto Identify]. This starts initial interrogation of the pacemaker. The cardiac dashboard
appears in the main window (see Section 4.3). Press [Stop] to return to the Select
Model window.
The [Start] button can only be used to launch applications that are not started with auto
identify.
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C-series Reference Manual Section 4.2
Notes:
If the programmer is unable to identify the pacemaker the following message is
•
displayed: “Position programming head”.
In the unlikely event that more than one pacemaker is in close proximity to the
•
programming head, the programmer will warn you that more than one pacemaker
has been detected. The pacemakers are then listed and you are asked to select the
one to be interrogated.
4.2.3 Starting a reloaded data session
Select the “Programmer” icon and choose the reload session data option to reload
session data stored on diskette. For more information, see Section 4.8.3.
4.2.4 Starting the Analyzer program
If the Medtronic lead analysis software and hardware are installed on the programmer,
the Vitatron desktop will contain the “Analyzer” icon. Clicking the icon starts the analyzer
program. After ending the analyzer program the programmer restarts the Vitatron
software. For more information about the analyzer please refer to the documentation
provided with it.
4.2.5 Adjusting programmer settings
Select the “Programmer” icon to change the programmer time and date, audio or printer
options, turn the Therapy Advisor on or off, manage memory contents files or check the
software version. See Section 4.10 for more information.
4.3 How to use the cardiac dashboard
When the pacemaker has been identified with [Auto Identify], the programmer starts
initial interrogation of the pacemaker. When pacemaker interrogation is complete
(indicated by a progress bar), the cardiac dashboard appears. The cardiac dashboard
gives an overview of how the pacemaker has performed during the last follow-up period.
Therapy Advisor messages and the most important patient and pacemaker information
indicate whether the pacemaker may need reprogramming to optimize pacing therapy.
If you change pacemaker settings or measurements during the follow-up session, the
cardiac dashboard is updated.
You can select the “Dashboard” icon at any time to return to the cardiac dashboard.
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C-series Reference Manual Section 4.3
Figure 4. Cardiac dashboard window
1 Therapy Advisor window – The main Therapy Advisor messages are shown here,
if the Therapy Advisor is switched on. For a description of the Therapy Advisor, see
Section 7.2.
2 Dynamic window – Press one of the underlined hyperlinks on the cardiac dashboard
to display more detailed information in the dynamic window. If you press a Therapy
Advisor hyperlink, details and programming advice appear in this window. If you press
a parameter or diagnostic hyperlink, the dynamic window contains a graph showing its
history over the previous follow-up periods. The anticoagulation information in the Burden
graph comes from details entered in the Patient window.
The graphs are based on the History data in the pacemaker (see Section 6.8 and
Section 7.4.2). If any relevant parameter settings were changed between history periods,
no trend line will be shown on the graph.
3 Patient summary – This gives a summary of the most important pacing and sensing
data during the follow-up period, including notes from the Patient window. The Episodes
information applies to data collected during the follow-up period, and does not reflect any
episode trigger changes in the current follow-up session.
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C-series Reference Manual Section 4.3
4 Pacemaker information – This contains technical information on parameter settings,
battery and lead status, threshold and testing results. If no information is available, “---” is
displayed. If “***” is displayed, this means that no senses were detected during a test.
If you change any settings during the follow-up session, the cardiac dashboard will show
the new value. At initial interrogation, the P-wave amplitude is derived from the P-wave
amplitude histogram. If a P-wave amplitude test is carried out during the follow-up
session, the test result replaces the initial value. R-wave information is only available
after an R-wave amplitude test has been performed during the follow-up session.
5 Control panel – The control panel icons are used to access stored information and to
perform programming and test functions during a follow-up session.
6 Button line – During a follow-up session, the bottom line normally contains three
buttons:
The [Emergency] button is always active during a follow-up session. When pressed
•
it programs the pacemaker to emergency settings (see Section 4.12).
The [Print] button prints the data displayed in the current window (see Section 4.9.1).
•
The [End Session] button allows you to close the follow-up session (see
•
Section 4.3.2). There is also an option to save pacemaker data to diskette or the
network before closing the session.
Note: You cannot program parameters in this window. Select the “Parameters” icon to
change parameter values.
A number of symbols may appear on the cardiac dashboard or in diagnostics and
parameter programming windows (see Table 2).
Table 2. Programmer symbols
Symbol
Description
When pressed, shows more detailed information or the history of a parameter in
the dynamic window. The last hyperlink pressed changes from green to blue.
When pressed, leaves the cardiac dashboard and jumps directly to the relevant
diagnostic, test or therapy programming window.
When pressed, leaves the cardiac dashboard and jumps directly to the stored
EGM window of the first episode in the Selected Episodes diary.
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C-series Reference Manual Section 4.3
Table 2. Programmer symbols (continued)
Symbol
Description
Indicates the nominal (delivery) value of the parameter concerned.
Indicates the currently programmed value of the parameter concerned.
Indicates that more information is available. This information will appear if the
icon is pressed.
Indicates either a warning about possible undesirable interaction with other
parameters, or a caution about using an option. If the icon is pressed, it displays
an explanation of the warning or caution.
Warns that certain parameters are not programmable, or that certain values are
not allowed because of a conflict with other parameters.
4.3.1 The ECG window
During a follow-up session, the programmer can display recordings from up to seven
sources. The ECG leads I, II and III are always available and are detected via skin
electrodes, if the programmer is connected to these electrodes with the ECG cable.
Filtered atrial and ventricular EGMs (AEGM and VEGM) can be switched on and off
as desired. The Marker Annotation and Marker Intervals can be superimposed on an
ECG to facilitate interpretation.
For information on arranging the recordings and adjusting the ECG window display,
see Section 4.11.
The top left-hand corner of the ECG window shows the current heart rate (paced or
sensed) and the corresponding interval in milliseconds; this information is derived from
the ECG markers.
During tests, multiple recordings are displayed. The signals are the previously displayed
surface ECG combined with marker annotations and the intracardiac electrogram (EGM)
of the chamber being tested.
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C-series Reference Manual Section 4.3
Marker intervals – The programmer automatically measures the intervals between pace
and sense markers and displays them (in milliseconds) as a separate recording. For dual
chamber modes the AV intervals and the VV intervals are displayed. For single chamber
modes the AA or VV intervals are displayed, depending on the chamber being paced.
Marker annotation – Marker annotations depict pacemaker operation by showing events
as they occur. These annotations are intended to simplify ECG interpretation. Typically,
the Marker Annotation channel is superimposed on an ECG recording. Atrial events are
shown above the baseline and ventricular events below it.
Press [i] in the top right-hand corner of the window for an explanation of marker
annotations.
The following marker annotations are used:
Atrial events
•
– AP Atrial pace
– AS Atrial sense
– BS Atrial sense in blanking period
– PC Premature atrial contraction
– RC Retrograde atrial sense
– RS Atrial sense in refractory period
– SP Atrial synchronization pace
– TS Atrial tachy sense
– +P Triggered atrial pace
Ventricular events
•
– RS Ventricular sense in refractory period
– VE Premature ventricular contraction
– VP Ventricular pace
– VS Ventricular sense
– XP Ventricular safety pace
– +P Triggered ventricular pace
Note: Parameter programming or pacemaker interrogation may momentarily interrupt the
transmission of the EGM or marker annotations. This can result in missing markers on
the recording.
30