Device Model 8042
Vision® Programmer Software Model 9981
Device Reference Guide
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
InSync III Model 8042
0
Device Reference Guide
A reference guide for information about the InSync III Model 8042 Device.
Refer to the InSync III Model 8042 Device Programming Guide for
information on programming this device.
0
The following list includes trademarks or registered trademarks of Medtronic in the
United States and possibly in other countries. All other trademarks are the property of
their respective owners.
6Telemetry and transtelephonic follow-up features 107
Te l e m e t e r e d Da ta1 0 8
Extended Telemetry 113
Features for Transtelephonic Follow-up114
7Miscellaneous operations 117
Magnet Mode Operation 118
InSync III Model 8042 Device Reference Guide
6
Contents
Temporary Programming 120
Electrical Reset 121
Elective Replacement Indicator (ERI) 122
Emergency Pacing 123
8Diagnostics 125
Automatic Diagnostic Data Collection 126
About the Data Displays 128
9Troubleshooting the device system 139
Troubleshooting Strategy 140
Troubleshooting Electrical Problems141
Troubleshooting Hemodynamic Problems 143
Device Longevity145
Replacing the Device 146
Patient Information and Service 147
A Device description 151
Basic Description 152
Lead Compatibility152
Radiopaque Identification Codes 153
Physical Dimensions153
Connector Dimensions 153
B Preset parameter settings155
Shipping Settings 156
Nominal Settings 159
Electrical Reset Settings 162
Emergency Settings 165
C Device programming recommendations 167
Device Programming Recommendations 168
V-V Delay Programming Recommendations 172
D Longevity projections, battery information 177
Estimated Longevity Projections 178
Prolonged Service Period 180
Elective Replacement Indicator (ERI) 180
Battery Specifications 181
InSync III Model 8042 Device Reference Guide
E Telemetry and diagnostic values 183
Magnet Mode Operation 184
Telemetry Functions 185
Automatic Diagnostics 188
F Parameter values and restrictions 191
Programmable Modes and Parameters 192
Parameter Programming Restrictions 197
Temporary Parameters 198
G Warnings, precautions, and EMI 199
Warnings 200
Precautions 205
Potential Complications 210
Potential Events 211
Hospital or Medical Environment Interference211
Home and Job Environment Interference 214
H Clinical Studies 217
Clinical Studies 218
Contents
7
Index 219
IGlossary 227
InSync III Model 8042 Device Reference Guide
Required Physician Training
In order to implant a Medtronic biventricular pacing system, the
physician is required to:
1. Thoroughly read this manual, and all associated device
and/or lead technical manuals.
2. Provide a copy of the patient manual to the patient and
discuss it with him or her and any other interested parties.
3. Be trained on the following topics:
■
Indications for use
■
Device operation to ensure therapy delivery
■
Measuring and managing biventricular thresholds
■
Assembly and use of LV lead implant tools
■
Placement of the LV lead
■
Patient management and system follow-up
Prior to implanting the system, Medtronic will certify that
physicians received training.
9
Required Physician Training
How to Use This Guide
Information is Contained in Two Guides
Product information about the InSync III Model 8042 and use of
the 9790 series programmer is presented in two separate guides:
■
The InSync III Model 8042 Device Reference Guide, which is
supplied with the applicable programmer software and
contains instructions on how to use the programmer with
the InSync III device.
■
This guide, the InSync III Model 8042 Device Reference
Guide, which is a supplementary guide that provides detailed
information about the InSync III device model.
Note: A small technical manual, which contains information about
implantation, is also supplied with each InSync III device.
InSync III Model 8042 Device Reference Guide
10
How to Use This Guide
About this Guide
This reference guide covers the information listed below. Included
are descriptions of how the various device functions operate.
■
The pacing modes, rate response options, special therapy
features, telemetry types, and data collection options. In some
cases, guidelines are given on how to configure device
operation.
■
Parameter and data collection capabilities, longevity
projections, and mechanical and electrical specifications.
■
Troubleshooting information for electrical and hemodynamic
problems.
■
Warnings, precautions, and potential interference sources.
About the Device Programming Guide
The device programming guide provides the following information.
■
How to setup and configure the programmer and access
on-line help.
■
How to start a patient session, use the various follow-up
features during the session, and properly end the session.
■
How to view and print the patient’s ECG and EGM waveform
traces.
■
How to configure the device to collect diagnostic data, and
how to retrieve and view this information.
■
How to measure stimulation thresholds and sensing levels.
■
How to program parameter values and verify rate response
parameters settings.
InSync III Model 8042 Device Reference Guide
Understanding device operation
Part I
Pacing modes and the mode
Pacing Modes 14
Programming Mode Switch 35
switch option
1
1
14
Chapter 1
Pacing Modes
Pacing Modes
Biventricular Pacing
Atrial Pacing Modes
The information in this section provides an introduction to pacing
modes as an aid to mode selection. Included are parameter
pertinency tables showing which parameters apply to each pacing
mode (asynchronous modes are not included) and a description of
each of the available modes.
Note: The pacing mode descriptions presented in this section are
not affected by the use of biventricular pacing. Ventricular timing is
always based on the first ventricular pace. The VP (ventricular
pace) markers in the mode timing illustrations can be interpreted
as either a single VP or a BV (biventricular pace).
The InSync III Model 8042 provides the option to program atrial
pacing modes. Atrial pacing modes, however, do not provide
ventricular resynchronization.
Warning: The atrial only pacing modes available with the InSync
III device do not provide cardiac resynchronization for heart failure
patients.
InSync III Model 8042 Device Reference Guide
NBG Pacing Codes
CHAMBER PACED
V = Ventricle
A = Atrium
D = Dual Chamber
S = Single Chamber
O = None
CHAMBER SENSED
V = Ventricle
A = Atrium
D = Dual Chamber
S = Single Chamber
O = None
MODE OF RESPONSE
T = Triggered
I = Inhibited
D = Double (Both)
O = None
PROGRAMMABLE/
RATE RESPONSE
P = Programmable
M = Multiprogrammable
C = Communicating
R = Rate Responsive
O = None
DDDR
Pacing modes and the mode switch option
Pacing Modes
The pacing modes are defined in the NBG code.1 Each five-letter
NBG code describes a specific type of operation for implantable
pacing devices. For simplicity, this manual uses only the first three
or four letters, such as DDD, DDIR, DVIR. Figure 1-1 describes
the first four letters of the NBG code.
These pacing modes are used for conventional pacing. Currently
there are no established pacing codes for biventricular pacing.
Figure 1-1. NBG Pacing Codes
15
Further Information
The mode descriptions in this chapter provide only a basic
overview of each mode. For further details on the rate response,
timing and therapy capabilities refer to “Programming rate and
rate response parameters” on page 39, “AV intervals, refractory
and blanking periods” on page 55, and “Special therapy options”
on page 95, respectively.
1
Bernstein A., et al., “The NASPE/BPEG Pacemaker Code,” PACE, 10(4),
Jul-Aug 1987. [“NBG” stands for The North American Society of Pacing and
Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group
(BPEG) Generic. NBG’s five-letter code supersedes the ICHD Code.]
InSync III Model 8042 Device Reference Guide
16
Chapter 1
Pacing Modes
). Dashes (–) indicate parameters that are
✓
✓ ✓ ✓✓✓✓✓
✓✓✓
–
–
✓✓
✓✓
–
–
✓✓✓
✓
✓
c
✓ ✓ ✓✓✓✓✓
✓ ✓ ✓✓✓✓✓
✓ ✓ ✓✓✓✓✓
✓ ✓ ✓✓✓✓✓
✓ ✓ ✓✓✓✓✓
✓ ✓ ✓✓✓✓
✓✓✓
✓✓✓ ✓ ✓
a
Pacing ParameterDDDRDDDDDIRDDIDVIRDVIVDD
Modes/Rates
Lower Rate
Table 1-1 and Table 1-2 show which pacing parameters and features are pertinent to each
pacing mode as indicated by check marks (
programmable when Mode Switch is enabled.
Asynchronous modes are not shown. The following parameters, which apply to all modes in the
Tabl e 1-1. Pacing Parameters Pertinent to Dual Chamber Modes (Including VDD)
tables, are also not shown: Pulse Width, Amplitude, Sensitivity, Pace Polarity, and Sense
Polarity.
Mode Pertinency Tables
InSync III Model 8042 Device Reference Guide
d
b
Mode Switch
Upper Tracking Rate
Upper Sensor Rate
Rate Response
Ventricular Pacing Configuration
Ventricular Pacing
First Chamber Paced
V-V Pace Delay
Ventricular Sense Response
Maximum Response Rate
A-V IntervalsdPaced AV Interval
Sensed AV Interval
Rate Adaptive AV
Refractory/Blanking Periods
✓✓✓✓✓
✓✓✓✓✓
✓ ✓ ✓✓✓✓✓
✓ ✓ ✓✓✓✓
✓ ✓ ✓✓✓✓✓
✓ ✓ ✓✓✓✓✓
✓✓
✓✓✓
✓✓✓✓✓
Pacing modes and the mode switch option
Pacing Modes
✓ ✓ ✓✓✓✓
17
Tabl e 1-1. Pacing Parameters Pertinent to Dual Chamber Modes (Including VDD) (continued)
Pacing ParameterDDDRDDDDDIRDDIDVIRDVIVDD
PVARP (including Auto PVARP)
PVAB
Ventricular Refractory
Ventricular Blanking (after AP)
Interventricular Refractory
Additional FeatureseSleep Function
Non-Competitive Atrial Pacing
PMT Intervention
PVC Response
See Chapter 2 for a description of the rate and rate response parameters.bSee Chapter 1 for a description of Mode Switch operation.cSee Chapter 4 for a description of the Ventricular Pacing Configuration parameters.dSee Chapter 3 for a description of these timing parameters.eSee Chapter 5 for a description of these special therapy options.
Tabl e 1- 2. Pacing Parameters Pertinent to Single Chamber Modes
InSync III Model 8042 Device Reference Guide
Maximum Response Rate
Refractory/Blanking PeriodscPVAB
✓✓✓✓✓
Ventricular Refractory
Ventricular Blanking (after AP)
✓✓✓✓✓
Interventricular Refractory
Atrial Refractory
✓ ✓ ✓✓✓ ✓ ✓ ✓✓✓
Additional FeaturesdSleep Function
See Chapter 2 for a description of the rate and rate response parameters.bSee Chapter 4 for a description of the Ventricular Pacing Configuration parameters.cSee Chapter 3 for a description of refractory and blanking periods.dSee Chapter 5 for a description of the Sleep function.
a
Atrial Blanking
Indications and Usage
The Medtronic InSync III Model 8042 is indicated for NYHA
Functional Class III and IV patients who remain symptomatic
despite stable, optimal medical therapy (as defined in the clinical
trials section), and have a left ventricular ejection fraction ≤ 35%
and a prolonged QRS duration.
Rate adaptive pacing is provided for those patients developing a
bradycardia indication who might benefit from increased pacing
rates concurrent with increases in activity.
Dual chamber and atrial tracking modes are indicated for patients
who may benefit from maintenance of AV synchrony.
Contraindications
Dual chamber atrial pacing is contraindicated in patients with
chronic refractory atrial tachyarrhythmias.
Asynchronous pacing is contraindicated in the presence
(or likelihood) of competitive paced and intrinsic rhythms.
Unipolar pacing is contraindicated in patients with an implanted
defibrillator (ICD) because it may cause unwanted delivery or
inhibition of defibrillator or ICD therapy.
Pacing modes and the mode switch option
Pacing Modes
19
Clinical Outcomes
Medtronic biventricular pacing systems for cardiac
resynchronization therapy have demonstrated the following
clinical benefits through prospectively defined clinical studies:
■
Improved NYHA functional class
■
Improved quality of life
■
Improved exercise capacity
■
Reduced risk of all cause mortality
■
Reduced risk of all cause mortality or unplanned
cardiovascular hospitalization
■
Reduced risk of all cause mortality or unplanned heart failure
hospitalization
See the Medtronic InSync IIIModel 8042 Implant Manual for
details on study design, objectives, and results.
InSync III Model 8042 Device Reference Guide
20
Chapter 1
Pacing Modes
DDDR Mode
In the DDDR mode, the device tracks the faster of the intrinsic
atrial rate or the sensor-indicated rate. If the intrinsic rate is faster,
the DDDR mode provides atrial synchronous pacing; otherwise,
AV sequential pacing occurs at the sensor-indicated rate.
■
Rate limits for atrial tracking (Upper Tracking Rate)1 and
sensor tracking (Upper Sensor Rate) are separately
programmable.
■
The AV intervals that follow sensed atrial events (SAV) and
paced atrial events (PAV) are separately programmable, and
they can be programmed to shorten with increasing rates
(Rate Adaptive AV).
■
A nonrefractory sensed event in either chamber inhibits
pacing in that chamber. A ventricular nonrefractory sensed
event in the VA interval that is not preceded by an atrial sense
(AS or AR) is a device-defined PVC, and starts a new VA
interval.
This mode may be appropriate for heart failure patients as it
provides both AV synchrony and cardiac resynchronization
therapy.
Rate responsiveness has not been evaluated in this patient
population.
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a
lesser value.
Sensor-indicated Rate = 90 ppm (667 ms) SAV Interval = 170 ms
Sensor-indicated
Interval
Figure 1-2. Example of DDDR Mode Operation
21
Pacing Modes
DDD Mode
The DDD mode provides atrial synchronous pacing in the
presence of intrinsic atrial activity; otherwise, AV sequential pacing
occurs at the Lower Rate.
■
Each atrial paced or nonrefractory atrial sensed event starts
an AV interval and a lower rate interval. The AV intervals that
follow sensed atrial events (SAV) and paced atrial events
(PAV) are separately programmable, and the SAV may be
optionally programmed to shorten with increasing rate (Rate
Adaptive AV).
■
A ventricular paced event may track atrial sensed events up to
the programmed Upper Tracking Rate.
■
A ventricular nonrefractory sensed event in the VA interval that
is not preceded by an atrial sense (AS or AR) is a
device-defined PVC, and starts a new VA interval.
This mode is appropriate for heart failure patients as it provides
both AV synchrony and cardiac resynchronization therapy.
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a
lesser value.
The DDIR mode provides dual chamber, sensor-driven,
atrioventricular (AV) sequential pacing for heart rate variation
without atrial tracking.
■
Atrial pacing occurs at the sensor-indicated rate, with
ventricular pacing at the end of the PAV interval unless
inhibited.
■
An atrial event sensed outside the PVARP will inhibit a
scheduled atrial stimulus but will not start an AV interval. That
is, ventricular paced events after such sensed atrial events
occur at the sensor-indicated rate. The following
ventriculoatrial (VA) interval may be extended slightly to avoid
an increasing atrial paced rate.
■
A ventricular nonrefractory sensed event in the VA interval
starts a new VA interval.
DDIR mode should not be permanently programmed in heart
failure patients with normal sinus rhythm. The device will switch to
DDIR/DDI modes when a mode switch occurs. Mode switch may
be appropriate for patients with a history of atrial arrhythmias.
The DDI mode provides dual chamber atrioventricular (AV)
sequential pacing with atrial sensing but without atrial tracking.
■
Atrial pacing occurs at the Lower Rate, with ventricular pacing
at the end of the PAV interval unless inhibited.
■
An atrial event sensed outside the PVARP will inhibit a
scheduled atrial stimulus but will not start an AV interval.
Ventricular paced events after such sensed atrial events occur
at the Lower Rate.
■
A ventricular nonrefractory sensed event in the ventriculoatrial
(VA) interval starts a new VA interval.
DDI mode should not be permanently programmed in heart failure
patients with normal sinus rhythm. The device will switch to
DDIR/DDI modes when a mode switch occurs. Mode switch may
be appropriate for patients with a history of atrial arrhythmias.
The DVIR mode provides AV sequential pacing at the
sensor-indicated rate unless inhibited by ventricular sensed
events.
■
■
Atrial pacing occurs at the sensor-indicated rate, with
ventricular pacing at the end of the PAV interval unless
inhibited.
The DVIR mode ignores intrinsic atrial events. Sensing occurs
only in the ventricle. A ventricular nonrefractory sensed event
during the ventriculoatrial (VA) interval starts a new VA
interval.
DVIR mode is not appropriate for heart failure patients with normal
sinus rhythm.
The DVI mode provides dual chamber AV sequential pacing
without atrial sensing/tracking.
■
Atrial pacing occurs at the Lower Rate, with ventricular pacing
at the end of the PAV interval unless inhibited.
■
Sensing occurs only in the ventricle, and intrinsic atrial events
are ignored. A ventricular nonrefractory sensed event during
the VA interval starts a new ventriculoatrial (VA) interval.
DVI mode is not appropriate for heart failure patients with normal
sinus rhythm.
The VDD mode provides atrial synchronous pacing (or VVI pacing
at the Lower Rate). The ventricles are paced synchronously up to
the programmed Upper Tracking Rate.
the atrium and ventricle, but pacing occurs only in the ventricles.
■
■
1
Sensing occurs in both
To promote atrial synchronous pacing at slow rates, a sensed
atrial event occurring near the end of the Lower Rate interval
will be followed by the programmed maximum SAV interval.
The result is an extension of the ventricular lower rate.
A ventricular nonrefractory sensed event in the V-V interval
that is not preceded by an atrial sense (AS or AR) is a
device-defined PVC, and it starts a new V-V interval.
This mode is appropriate for heart failure patients as it provides
InSync III Model 8042 Device Reference Guide
both AV synchrony and cardiac resynchronization therapy.
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser
value.
The VVIR mode provides ventricular rate responsive pacing in
patients for whom atrial-based pacing is deemed unnecessary or
inappropriate. In the absence of sensed events, the ventricles are
paced at the sensor-indicated rate.
The VDIR mode operates the same as the VVIR mode except that
events sensed in the atrium are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
concurrent ECG, this mode may be used to observe the underlying
atrial rhythm without affecting ventricular pacing.
Note: In the VVIR and VDIR modes, ventricular refractory sensed
events restart the Upper Sensor Rate interval.
VVIR/VDIR modes are generally not appropriate for heart failure
patients with normal sinus rhythm. In these modes, patients may
not receive cardiac resynchronization therapy.
Sensor-indicated Rate = 90 ppm (667 ms) Ventricular Refractory Period = 300 ms
Sensor-indicated
Interval
Sensor-indicated
Interval
Sensor-indicated
Interval
Upper Sensor
Rate Interval
Chapter 1
Pacing Modes
Figure 1-9. Example of VVIR Mode Operation
VVI / VDI Modes
The VVI mode provides single chamber inhibited pacing at the
programmed Pacing Rate unless inhibited by sensed events.
Sensing occurs only in the ventricle.
The VDI mode operates the same as the VVI mode except that
events sensed in the atrium are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
InSync III Model 8042 Device Reference Guide
concurrent ECG, this mode may be used to observe the underlying
atrial rhythm without affecting ventricular pacing.
VVI/VDI modes are generally not appropriate for heart failure
patients with normal sinus rhythm. In these modes, patients may
not receive cardiac resynchronization therapy.
Pacing modes and the mode switch option
Pacing Rate Interval
Parameters:
Pacing Rate = 60 ppm (1000 ms)
Ventricular Refractory Period = 300 ms
Pacing Rate Interval
Figure 1-10. Example of VVI Mode Operation
Other Available Modes
29
Pacing Modes
Warning: Atrial only pacing modes do not provide cardiac
resynchronization.
AAIR / ADIR Modes
The AAIR mode provides atrial-based rate responsive pacing in
patients with intact AV conduction. Sensing and pacing occur only
in the atrium. In the absence of sensed events, the chamber is
paced at the sensor-indicated rate.
The ADIR mode operates the same as the AAIR mode except that
events sensed in the ventricle are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
concurrent ECG, this mode may be used to observe the conducted
ventricular rhythm without affecting atrial pacing.
Note: In the AAIR and ADIR modes, atrial refractory sensed
events do not restart the Upper Sensor Rate interval.
AAIR/ADIR modes are generally not appropriate for heart failure
patients with normal sinus rhythm. In these modes, patients may
not receive cardiac resynchronization therapy.
The AAI mode provides single chamber inhibited atrial pacing.
Sensing and pacing occur only in the atrium. Pacing occurs at the
programmed Pacing Rate unless inhibited by sensed events.
The ADI mode operates the same as the AAI mode except that
events sensed in the ventricle are recorded by the diagnostics.
When used in conjunction with Marker Channel recordings and
concurrent ECG, this mode may be used to observe the conducted
ventricular rhythm without affecting atrial pacing.
AAI/ADI modes are generally not appropriate for heart failure
patients with normal sinus rhythm. In these modes, patients may
not receive cardiac resynchronization therapy.
InSync III Model 8042 Device Reference Guide
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