Medtronic C60A1B Reference Guide

C-series
C60 DR C20 SR
C-series VSF04 1.3 (Vitatron CareLink)
C60A1 C20A1
Reference Manual
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
C-series Reference Manual
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 C60A1) . . . . . . . . . . . . . . . . . . . . . 9
2.3 Vitatron C20 SR (Model C20A1) . . . . . . . . . . . . . . . . . . . . . 9
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2 Getting started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.3 Adjusting the programmer settings . . . . . . . . . . . . . . . . . . 24
4.4 Pacemaker follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.5 Emergency programming . . . . . . . . . . . . . . . . . . . . . . . . . 42
4.6 Viewing and adjusting the ECG . . . . . . . . . . . . . . . . . . . . . 43
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C-series Reference Manual
Part II Follow-up and diagnostics . . . . . . . . . . . . . . . . . . . . . . 55
5 Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.2 Post-implant configuration . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.3 Record an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.4 Program patient information . . . . . . . . . . . . . . . . . . . . . . . 56
5.5 Checks and programming . . . . . . . . . . . . . . . . . . . . . . . . . 57
5.6 Optimizing the pacemaker . . . . . . . . . . . . . . . . . . . . . . . . . 59
5.7 The ECG/EGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5.8 Follow-up frequency and longevity . . . . . . . . . . . . . . . . . . 60
6 Optimizing pacing and sensing . . . . . . . . . . . . . . . . . . . . . . . 67
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
6.2 Optimizing pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
6.3 Optimizing sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6.4 VA interval measurement . . . . . . . . . . . . . . . . . . . . . . . . . 79
6.5 Temporary test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
6.6 Lead measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
7 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
7.2 Therapy Advisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
7.3 Data collection and storage periods . . . . . . . . . . . . . . . . . 90
7.4 Displaying diagnostic data . . . . . . . . . . . . . . . . . . . . . . . . . 92
7.5 Assessing atrial rhythm . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
7.6 Assessing ventricular rhythm . . . . . . . . . . . . . . . . . . . . . . 100
7.7 Assessing AV synchrony . . . . . . . . . . . . . . . . . . . . . . . . . 104
7.8 Assessing rate response . . . . . . . . . . . . . . . . . . . . . . . . . 105
7.9 Assessing sensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Part III Pacing therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
8 An introduction to Vitatron pacing therapies . . . . . . . . . . . 113
8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
8.2 Basic pacing therapies . . . . . . . . . . . . . . . . . . . . . . . . . . 114
8.3 Pacemaker timing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
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8.4 Lower rate pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
8.5 Maximum rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
8.6 Refractory period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
8.7 Blanking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
8.8 Ventricular safety pacing (VSP) . . . . . . . . . . . . . . . . . . . . 123
8.9 Atrial hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
8.10 Interference management . . . . . . . . . . . . . . . . . . . . . . . . 127
9 Rate stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
9.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
9.2 Atrial rhythm classification . . . . . . . . . . . . . . . . . . . . . . . . 129
9.3 Atrial tracking behavior . . . . . . . . . . . . . . . . . . . . . . . . . . 131
9.4 Bradyarrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
9.5 Atrial tachyarrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
10 AV synchrony . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
10.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
10.2 Paced and sensed AV delay . . . . . . . . . . . . . . . . . . . . . . 140
10.3 Adaptive AV delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
10.4 AV delay hysteresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
10.5 Atrial synchronization pace (ASP) interval . . . . . . . . . . . 145
10.6 Retrograde conduction and PVC management . . . . . . . . 146
11 Rate response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
11.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
11.2 Activity sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
11.3 Slope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
11.4 Daily learning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
11.5 Fast learning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
11.6 Activity acceleration and deceleration . . . . . . . . . . . . . . . 158
Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
A Safety features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
A.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
A.2 Pacemaker restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
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B Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
B.1 Effects of extreme conditions . . . . . . . . . . . . . . . . . . . . . 165
B.2 Area restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
B.3 Environmental and medical therapy hazards . . . . . . . . . 165
C Product specifications Vitatron C60 DR, ............................. 171
C.1 Programming parameters . . . . . . . . . . . . . . . . . . . . . . . . 171
C.2 Technical parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
D Product specifications Vitatron C20 SR .............................. 177
D.1 Programming parameters . . . . . . . . . . . . . . . . . . . . . . . . 177
D.2 Technical parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
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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.
In Part III, there is an extensive description of the pacing therapies. The basic pacing therapies, including timing characteristics are described in Chapter 8. This is followed by advice on maintaining rate stability (see Chapter 9), the importance of maintaining and restoring AV synchrony (see Chapter 10) and rate response (see Chapter 11).
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.
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C-series Reference Manual Section 1.2

1.2 Programming instructions

The gray block at the beginning of some sections contains instructions for programming the parameter. For example:
Parameters
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 4.4). You can press the value boxes named on the following lines to program the parameter.
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.
–1
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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.
Each pacemaker has a high quality ECG (EGM) and diagnostic tools which quickly provide information about the effectiveness of pacemaker therapy and simplify follow-up sessions.
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 and gives suggestions for programming the pacemaker.

2.2 Vitatron C60 DR (Model C60A1)

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:
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

2.3 Vitatron C20 SR (Model C20A1)

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:
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C-series Reference Manual Section 2.3
Therapy Advisor, which provides clear and concise advice on pacemaker settings
and therapies
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 2-1).
Figure 2-1. 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.
Rate responsive modes may be contraindicated if they are expected to aggravate clinical symptoms (angina pectoris for example) or congestive heart failure caused by fast heart rates.
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 3-1.
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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 3-1. The Revised NASPE/BPEG Generic Code for Antibradycardia Pacing

Position: I II III IV V
Category: Chamber(s)
Manufacturers’
designation
Paced O = None
A = Atrium V = Ventricle D = Dual (A + V)
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 3-1. 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
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
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C-series Reference Manual Section 3.7
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.
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
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C-series Reference Manual Section 3.7
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.
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:
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C-series Reference Manual Section 3.7
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

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:
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C-series Reference Manual Section 3.7
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.
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:
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C-series Reference Manual Section 3.7
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.
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

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, which describes how to perform various tasks using the programmer, is divided into five sections:
getting started (see Section 4.2)
adjusting the programmer settings (see Section 4.3)
starting a follow-up session, programming the pacemaker and general use of the
programmer (see Section 4.4)
emergency programming (see Section 4.5)
viewing and adjusting the ECG (see Section 4.6)
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.
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 Getting started

After switching the programmer on the Vitatron desktop appears.
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C-series Reference Manual Section 4.2

Figure 4-1. The Vitatron desktop

1 Top line 2 ECG window and controls 3 Control panel 4 Main window 5 Button line
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.

4.2.1 Top line

The desktop always shows the Vitatron logo on the top line. After a programming session is initiated, the applicable pacemaker model number is also shown. The top line is not shown in the illustrations used in this chapter.

4.2.2 ECG window and ECG controls

While the desktop is active, the programmer continuously displays the default surface Electrocardiogram (ECG, lead I, II or III) in the ECG window.
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C-series Reference Manual Section 4.2
The ECG controls on the right allow you to freeze the ECG, adjust the various ECG settings and ECG markers or recall previously stored ECGs. For a detailed explanation of these features see Section 4.6.
For instructions on connecting the ECG cable and leads, refer to the relevant programmer manual.

4.2.3 Control panel

This panel, on the right of the desktop, contains (in addition to the ECG controls) the following icons:
“Select Model” is used to launch a simulated programming session (demo) - see
Section 4.2.4.
“Programmer” gives access to programmer settings - see Section 4.3.
“Analyzer”. 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.

4.2.4 Main window

At start-up the main window always contains the Select Model window, which is used for demonstration purposes. Select a model and press [Demo] to launch a simulated programming session for the pacemaker in question. A pacemaker follow-up session is usually started by pressing [Auto Identify]. The [Start] button can only be used to launch applications that are not started with auto identify.

4.2.5 Button line

The bottom line normally contains two buttons:
[Auto Identify]. Pressing this button starts automatic recognition and interrogation
of the pacemaker.
Vitatron to Medtronic switch, which is used to go from Vitatron to Medtronic
applications and vice versa.
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C-series Reference Manual Section 4.3

4.3 Adjusting the programmer settings

Prior to launching pacemaker applications you are given the opportunity to change the main programmer settings. Selecting “Programmer” reveals the following list of options:
Programmer preferences
Time and date
Software
Memory contents files
Reload session data

4.3.1 Setting programmer preferences

This window allows you to set one or more of the following programmer preferences.

Figure 4-2. Programmer Preferences window

Language – To change the language, press the value box and select the desired
language from the list. The change takes immediate effect.
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C-series Reference Manual Section 4.3
Audio – To mark certain events (for example, programming confirmed, start/end emergency, end test, error) audible signals are used. The audio option allows you to switch the sound on or off. To do this press the “Audio” value box and select the desired option (Off, Low, Medium or High).
If the sound is switched off, only emergency beeps will still be audible. The last three options are equivalent to “On” and do not provide different volume levels.
Therapy Advisor – This allows you to switch the Therapy Advisor on or off.
Printer – This option is used to select the printer, which is either the built-in (thermal)
strip printer (the default setting) or a full-size external printer. If the full-size printer is selected, you can select the printer type from a drop-down list of all supported printers. A number of other print options are also listed:
Number of copies
The default number of copies to be printed is set using this option.
Pop-up print options dialog when any print button is selected
If this option is activated, every time you click a [Print] button in any window, the Print - Options window is opened, in which you can overrule the preference settings for a particular print job.
Auto print initial interrogation report
If this option is switched on (the default setting) the results of the initial pacemaker interrogation are printed as soon as they are available.
You can also adjust the printer preferences during a follow-up session by selecting the “Session” icon (see Section 4.4.6).

4.3.2 Adjusting time and date

This option allows you to adjust the current time and date in the programmer.
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C-series Reference Manual Section 4.3

Figure 4-3. Time and Date window

To change the programmer time or date, press the relevant value box and select the time or date. Press [Apply] to apply the changes. Press another icon to leave the window without making any changes.
Caution: The programmer clock is battery-powered so if the battery is depleted the date and time will be incorrect and should not be used to set the pacemaker time. A warning to this effect will be given by the programmer.

4.3.3 Checking software release numbers

The Software window shows the version numbers and service release numbers of the currently installed Vitatron software.
4.3.4 Managing memory contents files
The Memory Contents Files window lets you copy pacemaker memory files (memory dumps) from the programmer hard disk to diskette. This can be useful in the case of programming difficulties, if the pacemaker behavior cannot be interpreted, or if a pacemaker malfunction is suspected. In such cases, the programmer often generates a memory contents file. Availability of this file enables Vitatron specialists to evaluate the pacemaker status and assist during follow-up.
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C-series Reference Manual Section 4.3

Figure 4-4. Memory Contents Files window

All stored pacemaker memory contents files are listed. Each file name starts with an eight-digit number followed by a year code; if more than one file is listed the one with the highest number is the newest for that particular year.
To copy a selected file from the programmer to a disk, press [Copy to Diskette].
Use [Delete] to remove a selected file from the programmer.
Cautions:
Make sure only virus-free diskettes are used!
Remove the diskette from the disk drive before you turn the programmer off. Do
not switch the programmer on if a diskette is in the disk drive.

4.3.5 Reloading session data

Using this feature you can reload session data that has previously been saved to diskette (see Section 4.4.9). This enables you to perform the following actions:
Analyze (and compare) data from previous follow-ups.
Run demo follow-up sessions using different patient profiles.
If you choose the reload session data option you are asked to insert the relevant diskette into the programmer disk drive. The programmer subsequently displays a list of all session export files stored on the diskette.
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C-series Reference Manual Section 4.3

Figure 4-5. Reload Session Data window

Select the desired file and then press [Reload Data]. This loads the patient data and allows you to analyze the follow-up data or conduct a demo follow-up session.

Figure 4-6. Example of a Reloaded Data Parameters Therapy window

Reloaded sessions can be identified by the text “Reloaded Data” in the top line and by the fact that during a reloaded session ECG recordings are shown as a flat line. The reloaded sessions only contain the data that was read out during initial interrogation of the pacemaker. The results of any subsequent programming actions or measurements carried out during the follow-up session are not displayed, although they are stored on the diskette and can be accessed using commercially available software.
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C-series Reference Manual Section 4.3
During a reloaded session you can simulate a follow-up session and analyze the data. You can also “reprogram” pacing parameters; any changes may be reflected in the information presented on the programmer or in reports during the reloaded session. When you press [End] and return to the Vitatron desktop, all changes will be discarded. You cannot change the contents of the file on the diskette.

4.4 Pacemaker follow-up

To start automatic pacemaker recognition press [Auto Identify] and position the programming head. This starts initial interrogation of the pacemaker. Press [Stop] to return to the Select Model window.
When interrogation is complete (indicated by a progress bar), the Status window shows the most important pacemaker settings, as well as lead and battery information and Therapy Advisor messages. The top left-hand corner of the ECG window also shows the current heart rate (paced or sensed) and the corresponding interval in milliseconds. This information is derived from the ECG markers.

Figure 4-7. Status window

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C-series Reference Manual Section 4.4
The control panel icons are used to access stored information and to perform programming and test functions. These icons are described in the rest of this section.
During a follow-up session, the bottom line normally contains two buttons:
The [Emergency] button is always active during a follow-up session. When pressed
it programs the pacemaker to emergency settings (see Section 4.5).
The [End Session] button allows you to close the follow-up session (see
Section 4.4.7). There is also an option to save pacemaker data to diskette before closing the session.
A number of symbols may appear on the screen during interrogation and programming of the pacemaker. These are listed in Table 4-1.

Table 4-1. Programmer symbols

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.
Warns of a possible undesirable interaction with other parameters.
Warns that certain parameters are not programmable, or that certain values are not allowed because of a conflict with other parameters.
It is always advisable, after initial interrogation of the pacemaker, to print a copy of the pacemaker status for later reference. If the “Auto Print Initial Interrogation Report” preference is on (see Section 4.3.1) this is done automatically. If not, just press the [Print] button.
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