Dual chamber implantable cardioverter defibrillator with
cardiac resynchronization therapy including sequential
biventricular pacing and OptiVol®Fluid Monitoring
Reference Manual
Caution: Federal Law (USA) restricts this device to sale
by or on the order of a physician.
INSYNC SENTRY®7299
Reference Manual
A guide to the operation and programming of the Model 7299
InSync Sentry dual chamber implantable cardioverter defibrillator with
cardiac resynchronization therapy including sequential biventricular pacing
and OptiVol
A.1 General warnings373
A.2 Handling and storage instructions373
A.3 Device operation374
A.4 Lead evaluation and lead connection376
A.5 Follow-up testing378
A.6 Explant and disposal378
A.7 Medical therapy hazards378
A.8 Home and occupational environments381
BDevice parameters383
B.1 Emergency settings385
INSYNC SENTRY®7299Reference Manual
CDevice programming recommendations403
Glossary411
Index419
Contents
B.2 Detection parameters386
B.3 Therapy parameters387
B.4 Pacing parameters389
B.5 System maintenance parameters392
B.6 Data collection parameters394
B.7 System test and EP study parameters395
B.8 Fixed parameters398
B.9 Patient information parameters399
B.10 Programmer symbols400
B.11 Parameter interlocks402
C.1 Device programming recommendations405
C.2 V-V Delay programming recommendations407
9
INSYNC SENTRY®7299Reference Manual
Introduction
Using this manual
Before implanting the device, it is strongly recommended that you:
Manual conventions
Throughout this document, the word “device” refers to the
implanted InSync Sentry device.
Introduction
Refer to the product literature packaged with the device for
•
information about prescribing the device.
Thoroughly read this manual and the technical manuals for
•
the leads and the implant tools used with the device.
Discuss the procedure and the device system with the
•
patient and any other interested parties, and provide them
with any patient information packaged with the device.
11
Technical support
References
The
nominal value for that parameter.
On-screen buttons are shown with the name of the button
surrounded by brackets: [Button Name].
Medtronic employs highly trained representatives and engineers
located throughout the world to serve you and, upon request,
to provide training to qualified hospital personnel in the use of
Medtronic products.
In addition, Medtronic maintains a professional staff of consultants
to provide technical consultation to product users.
For more information, contact your local Medtronic representative,
or call or write Medtronic at the appropriate address or telephone
number listed on the back cover.
The primary reference for background information is Zacouto FI,
Guize LJ. Fundamentals of Orthorhythmic Pacing. In: Luderitz B,
ed.
Springer-Verlag; 1976: 212-218.
symbol in parameter tables indicates the Medtronic
Cardiac Pacing Diagnostic and Therapeutic Tools. New York:
INSYNC SENTRY®7299Reference Manual
12
Introduction
Notice
See these additional references for more background information:
Estes M, Manolis AS, Wang P, Eds.
•
Cardioverter-Defibrillators
Inc. 1994.
Kroll MW, Lehmann MH, Eds.
•
Cardioverter-Defibrillator Therapy: The Engineering-Clinical
Interface
Singer I, Ed.
•
NY: Futura Publishing Co. 1994.
Singer I, Barold SS, Camm AJ, Eds.
•
Therapy of Arrhythmias for the 21st Century: The State of
the Art
Software is provided as an informational tool for the end user.
The user is responsible for accurate input of patient information
into the software. Medtronic makes no representation as
to the accuracy or completeness of the data input into the
software. Medtronic SHALL NOT BE LIABLE FOR ANY DIRECT,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES TO
ANY THIRD PARTY WHICH RESULT FROM THE USE OF THE
INFORMATION PROVIDED IN THE SOFTWARE.
. Norwell, MA: Kluwer Academic Publishers 1996.
Implantable Cardioverter-Defibrillator. Armonk,
. Armonk, NY: Futura Publishing Co. 1998.
. New York, NY: Marcel Dekker,
Implantable
Implantable
Nonpharmacological
INSYNC SENTRY®7299Reference Manual
Quick overview
Part I
1Quick reference
1.1 Physical characteristics17
1.2 Magnet application18
1.3 Projected longevity19
1.4 Replacement indicators21
1.5 Typical charge times21
1.6 High-voltage therapy energy22
1.7 Stored data and diagnostics23
1.8 New and enhanced features24
1
1.1Physical characteristics
Table 1. Device physical characteristics
Volume
Mass
H x W x D
Surface area of device
can
Radiopaque ID
Materials in contact with
human tissue
BatteryLithium silver vanadium oxide
ConnectorsTwo IS-1 connectors for pacing and
a
Measurements are nominal values based on CAD (computer aided design)
model measurements and are rounded to the nearest unit.
b
Volume with connector holes unplugged.
c
Grommets may protrude slightly beyond the can surface.
d
Engineering series number follows the radiopaque code.
e
These materials have been successfully tested and verified for biocompatibility.
The device does not produce an injurious temperature in the surrounding tissue.
sensing, one IS-1 connector for
pacing, two DF-1 connectors for
high-voltage therapy, Active Can
electrode (programmable)
17
Table 2. Lead connections
Device portConnector typeSoftware name
SVC (HVX)DF-1SVC
RV (HVB)DF-1RVcoil
Can
—
Can
RVIS-1 bipolarRVtip and RVring
LVIS-1 bipolarLVtip and LVring
AIS-1 bipolarAtip and Aring
INSYNC SENTRY®7299Reference Manual
18
2
5
4
6
3
1
Chapter 1
Magnet application
Figure 1. Lead connections
1 SVC (HVX)
2 RV (HVB)
3 Can (HVA)
4 LV
5 RV
6 A
Figure 2. Suture holes
1.2Magnet application
Bringing a magnet close to the device triggers changes in device
operation as shown in Table 3. When the magnet is removed, the
device returns to its programmed operations.
For information on demonstrating Patient Alert tones to the
patient, see Section 11.3.4, “Instructing the patient”, page 271.
INSYNC SENTRY®7299Reference Manual
Table 3. Effects of magnet application on the device
Pacing modeas programmed
Pacing rate and intervalas programmed
VF, VT, and FVT detectionsuspended
Patient Alert audible tones
(20 s or less)
a
Rate response adjustments are suspended while a Patient Alert tone sounds.
b
Detection resumes if telemetry is established and the application software is
running, or detection resumes after the application software has started.
c
Or “VF Detection/Therapy Off” is the only alert enabled.
1.3Projected longevity
Longevity estimates are based on accelerated battery discharge
data and device modeling with EGM pre-storage off (see Table 4).
The following table displays projected longevity in years with
pacing outputs programmed to the specified amplitude and 0.4 ms
pulse width, DDD mode, 100% biventricular pacing, specified
percentage of atrial pacing at 60 ppm with the remainder at
70 ppm atrial tracking, and semiannual full-energy charges.
1Quick reference
Projected longevity
a
b
high/low dual tone (high urgency
•
alert occurred)
on/off intermittent tone (lower
•
urgency alert occurred)
continuous test tone (no alert
•
occurred)
no tone (alerts are disabled)
•
19
c
1
Table 4. Projected longevity in years
Amplitudes:
A/RV; LV
2.5 V; 3.0 V
% atrial
pacing
pacing
impedance
0%5.86.26.5
500 Ù
700 Ù
pacing
impedance
900 Ù
pacing
impedance
25%5.66.06.4
50%
100%5.2
3.0 V; 4.0 V
1
Semiannual full-energy charges may include therapy shocks or capacitor
formations. Additional full-energy charges due to therapy shocks, device
testing, or capacitor formation reduces device longevity by approximately 26
days (0.07 years). Additional 30 J charges due to therapy shocks or device
testing reduces device longevity by approximately 22 days (0.06 years).
0%4.9
5.5
6.06.3
5.7
5.5
INSYNC SENTRY®7299Reference Manual
6.1
5.8
20
Chapter 1
Projected longevity
Table 4. Projected longevity in years (continued)
Amplitudes:
A/RV; LV
The longevity of the ICD is dependent on several factors. The
following factors result in decreased longevity:
an increase in pacing rate, pacing amplitude, or pulse
•
width; the ratio of paced to sensed events; or the charging
frequency
a decrease in pacing impedance
•
using the pre-onset EGM storage feature or Holter telemetry
•
Considerations for using EGM pre-storage – When the EGM
pre-storage feature is programmed to Off, the device starts
to store EGM following the third tachyarrhythmia event and
also provides up to 20 s of information before the onset of the
tachyarrhythmia, including this information:
AA and VV intervals
•
Marker Channel
•
Interval Plot Flashback
•
% atrial
pacing
25%4.85.3
50%4.65.25.6
100%4.45.05.4
500 Ù
pacing
impedance
700 Ù
pacing
impedance
900 Ù
pacing
impedance
5.7
When the EGM pre-storage feature is programmed to On, the
device also collects up to 20 s of EGM information before the
onset of the arrhythmia.
In a patient who uniformly repeats the same onset mechanisms,
the greatest clinical benefit of pre-onset EGM storage is achieved
after a few episodes are captured. To maximize the effectiveness
of the EGM pre-storage feature and optimize device longevity,
consider these programming options:
Turn pre-storage to On to capture possible changes in the
•
onset mechanism following significant clinical adjustments,
for example, device implant, medication changes, and
surgical procedures.
Turn pre-storage to Off once you have successfully captured
•
the information of interest.
INSYNC SENTRY®7299Reference Manual
1.4Replacement indicators
Battery voltage and messages about replacement status appear
on the programmer display and on printed reports. The Elective
Replacement Indicator (ERI) and the End of Life (EOL) conditions
are listed in Table 5.
Table 5. Replacement indicators
Elective Replacement (ERI)≤ 2.62 V
End of Life (EOL)3 months after ERI
ERI date – The Quick Look and Battery and Lead Measurements
screens display the date when the battery reached ERI.
Temporary voltage decrease – The battery voltage temporarily
decreases following a high-voltage charge. If a battery
measurement is taken immediately after a high-voltage charge,
the ERI or EOL indicator may be displayed. However, this is a
temporary status that will return to normal when the battery has
recovered from the charge.
EOL indication – If the programmer indicates that the device is
at EOL, replace the device immediately.
1Quick reference
Replacement indicators
21
Post-ERI conditions – EOL device status is defined as 3 months
following an ERI indication assuming the following post-ERI
conditions: 0% DDD atrial pacing; 100% DDD RV and LV pacing
at 60 ppm; 3 V atrial and RV pacing amplitude; 4 V LV pacing
amplitude; 0.4 ms pulse width; 500 Ù pacing load; and six 35 J
charges. EOL may be indicated before the end of 3 months if the
device exceeds these conditions.
1.5Typical charge times
The most recent capacitor charge time appears on the
programmer display and on printed reports and can be evaluated
using the Charge/Dump test (see Table 6).
Table 6. Typical
At Beginning of Life (BOL)
At Elective Replacement (ERI)
a
These charge times are typical when the capacitors are fully formed.
a
full-energy charge times
7.1 s
9.0 s
INSYNC SENTRY®7299Reference Manual
22
Chapter 1
High-voltage therapy energy
1.6High-voltage therapy energy
The stored energy of the device is derived from the peak
capacitor voltage and is always greater than the energy delivered
by the device. Table 7 compares the programmed energy
levels delivered by the device to the energy levels stored in the
capacitors before delivery.
Table 7. Comparison of delivered (programmed) and stored energy levels
Energy ( J)Energy ( J)
a
Delivered
ProgrammedStored
a
Energy delivered at connector block into a 75 Ù load.
b
Energy stored at end of charge on capacitor.
c
Typical charge time at Beginning of Life (BOL) with fully formed capacitors, rounded to the nearest tenth of
Ventricular sensing episodes9 ventricular sensing episodes (longest, first, and 7
Counter data
Detection countersLifetime total, since cleared, and since last session
Episode countersEpisodes:
Therapy efficacy countersCounts for each VF, FVT, VT Therapy:
single-channel EGM
does not usually store detailed episode records for NST
episodes)
2 min of dual-channel EGM or 3.6 min of single-channel
EGM
latest VF, before latest VT, and before interrogation
latest): episode text
latest): intervals, markers, and counter data text
VF, FVT, and VT
•
Atrial Fibrillation/Atrial Flutter episodes
•
Sinus Tach episodes
•
Other 1:1 SVT episodes
•
NST episodes
•
Mode Switch episodes
•
Percentage pacing:
AS-VS, AS-VP, AP-VS, AP-VP percentages
•
Additional counters:
Single PVCs and PVC runs
•
Rate stabilization pulses and runs
•
Delivered
•
Successful
•
Unsuccessful
•
Intervention (manually aborted)
•
Total number of aborted shocks
23
INSYNC SENTRY®7299Reference Manual
24
Chapter 1
New and enhanced features
Table 8. Stored data and diagnostics (continued)
Other stored data
Patient Alert — System eventsUp to 10 log entries: text and date for the first time an
Battery and lead measurementsBattery voltage, last capacitor formation, last charge,
Lead performance trends14 days of daily measurements plus 80 weeks of weekly
Rate Histograms
Cardiac Compass trends14 months of daily measurements:
alert is triggered between interrogations
lead impedance, EGM amplitude measurements, last
high-voltage therapy, and sensing integrity counter
minimum and maximum measurements:
lead impedance: atrial pacing, RV pacing, LV
•
pacing, defibrillation pathway, and SVC lead (if
used)
atrial EGM amplitude (P-waves)
•
Atrial rate
•
Ventricular rate
•
Ventricular rate during AT/AF
•
VT and VF episodes per day
•
one or more high-voltage therapy delivered
•
ventricular rate during VT or VF
•
episodes of non-sustained tachycardia per day
•
total daily time in AT/AF
•
ventricular rate during AT/AF
•
percent pacing per day
•
average day and night ventricular heart rate
•
patient activity
•
heart rate variability
•
thoracic impedance
•
accumulated differences between the daily and
•
reference thoracic impedance (OptiVol fluid index)
1.8New and enhanced features
The following features are new or changed from the 7289 InSync
II Marquis ICD.
1.8.1Patient management
OptiVol Fluid Monitoring – The OptiVol Fluid Monitoring
feature is designed to assist the physician in assessing the
INSYNC SENTRY®7299Reference Manual
patient’s thoracic fluid status. When the device determines that
the patient’s thoracic fluid status has exceeded a programmed
threshold, an observation is displayed on the Quick Look screen
and Heart Failure Management Report at the next interrogation.
The OptiVol Fluid Monitoring feature is an additional source
of information for patient management and does not replace
assessments that are part of standard clinical practice.
OptiVol Fluid Trends – There are 2 OptiVol Fluid Trends:
The Thoracic impedance trend plots thoracic impedance for
•
up to 14 months. The Daily thoracic impedance is measured
between the RVcoil and Can.
The OptiVol fluid index trend plots the accumulated
•
differences between the daily and reference thoracic
impedance. Thoracic fluid accumulation may exist when the
OptiVol fluid index is greater than the OptiVol threshold.
The OptiVol Fluid Trends are included in the Cardiac Compass
and Heart Failure Management reports. For more information on
each trend, see Section 12.5.2.
1.8.2Tachyarrhythmia therapy
1Quick reference
New and enhanced features
25
Output – The InSync Sentry CRT-D has a maximum delivered
energy of 35 J.
1.8.3Cardiac resynchronization therapy
Sequential biventricular pacing – The ventricular sequence
and V-V pace delay are programmable to support improved
hemodynamics.
Pacing outputs for RV and LV are independently programmable.
INSYNC SENTRY®7299Reference Manual
2The InSync Sentry system
2.1 System overview29
2.2 Indications and usage33
2.3 Contraindications33
2.4 Patient screening33
2
2.1System overview
The Model 7299 InSync Sentry dual chamber implantable
cardioverter defibrillator with cardiac resynchronization therapy
(CRT-D) including sequential biventricular pacing and OptiVol
Fluid Monitoring is an implantable medical device system that
includes 3 major components:
CRT-D device
•
leads
•
programmer, software, and accessories
•
Each of these components is described in detail below.
Device – The device senses the electrical activity of the patient’s
heart using the sensing electrodes of the implanted atrial and
right ventricular leads. It then analyzes the heart rhythm based
on selectable sensing and detection parameters. The device
provides the following functions:
simultaneous or sequential biventricular pacing for cardiac
tachycardia, and fast ventricular tachycardia) with
defibrillation, cardioversion, and antitachycardia pacing
therapies
single or dual chamber pacing for patients requiring rate
•
support
diagnostics and monitors that evaluate the system and assist
•
in patient care
2The InSync Sentry system
System overview
®
29
Leads – The device can be used with transvenous or epicardial
defibrillation leads. The lead system should consist of bipolar or
paired unipolar pacing/sensing leads in the right atrium and right
ventricle of the heart, a pacing lead for the left ventricle, and 1 or
2 high-voltage cardioversion/defibrillation electrodes. In addition
to the lead system, the Active Can feature enables the device to
act as one of the high-voltage electrodes. The device delivers
pacing and cardiac resynchronization therapy via the atrial (A),
right ventricular (RV), and left ventricular (LV) leads. The device
senses using the atrial and RV leads. Cardioversion/defibrillation
therapy is delivered with 2 lead-based high-voltage electrodes, or
with the Active Can defibrillation electrode and 1 or 2 lead-based
high-voltage electrodes.
INSYNC SENTRY®7299Reference Manual
30
Chapter 2
System overview
The OptiVol Fluid Monitoring feature may be adversely affected
by the use of an epicardial defibrillation lead instead of an RVcoil.
Prior to implanting the left ventricular pacing lead, thoroughly
read the associated left ventricular lead technical manual.
Programmer and software – The Medtronic CareLink
Programmer, Model 2090,1and Model 9998 software application
allow you to perform the following functions:
configure the cardiac resynchronization, arrhythmia detection
•
and therapy, and bradycardia features for your patient
perform electrophysiological studies and system tests
•
monitor, display, or print patient cardiac activity information
•
Network connectivity and data exchange – The system
supports network connectivity and the exchange of data between
the Medtronic Carelink 2090 programmer and the Medtronic
Paceart data management system using the SessionSync feature.
Concurrent Analyzer – The system supports the use of the
Medtronic 2290 Analyzer, which allows you to have a device
session and an analyzer session running at the same time,
quickly switch from one to the other without having to end or
restart sessions, and export data from the analyzer to the device
software application.
Remote View – The system supports Remote View, which allows
you to use a personal computer in your office or elsewhere to
view the screen displays from a Medtronic Carelink programmer
in a clinic, hospital, or other location.
1
With the Model 2067 or Model 2067L programming head.
INSYNC SENTRY®7299Reference Manual
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