This manual describes the operation and intended use of the
Intrinsic Model 7288 and Intrinsic 30 Model 7287 systems.
In these systems, both devices provide ventricular
tachyarrhythmia detection and therapy and a full range of
dual-chamber bradycardia pacing modes and associated
features. Unless otherwise noted, all information in this manual
applies to both devices.
The full delivered energy is different for Intrinsic Model 7288
devices and Intrinsic 30 Model 7287 devices. Intrinsic devices can
be programmed to deliver a full energy of up to 35 J. Intrinsic 30
devices can be programmed to deliver up to 30 J. Throughout
the manual, the term "full-energy" refers to either 35 J or 30 J,
depending on the device model.
Programmer hardware and screen images
11
The screen image examples in this document show the Medtronic
CareLink Model 2090 programmer screen. Wherever possible,
these screen images show the application for an Intrinsic Model
7288 device.
The information provided in this manual about using the
programmer assumes the Medtronic CareLink Model 2090
Programmer is used. For information about using the Model
9790C Programmer, see the
Manual
Manual conventions
Throughout this document, the word “device” refers in general to
both Intrinsic and Intrinsic 30 devices.
The
nominal value for that parameter.
On-screen buttons are shown with the name of the button
surrounded by brackets: [Button Name].
.
symbol in parameter tables indicates the Medtronic
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
9790/9790C Programmer Instruction
12
Introduction
Additional literature
Technical support
Before implanting the device, it is strongly recommended that
you take the following actions:
Refer to the product literature packaged with the device for
•
information about prescribing the device.
Thoroughly read the technical manuals for the leads used
•
with the device.
Discuss the procedure and the device with the patient and
•
any other interested parties, and provide them with any
patient information packaged with the device.
Medtronic employs highly trained representatives and engineers
located throughout the world to ser ve 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 medical
consultation, Medtronic can often refer product users to outside
medical consultants with appropr iate expertise.
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.
Customer education
Medtronic invites physicians to attend an educational seminar
on the device. The course describes indications for use, system
functions, implant procedures, and patient management.
References
The primary reference for background information is Zacouto FI,
Guize LJ. Fundamentals of Orthorhythmic Pacing. In: Luderitz B,
Cardiac Pacing Diagnostic and Therapeutic Tools.
ed.
Springer-Verlag; 1976: 212-218.
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
New York:
Notice
Introduction
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
This 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 RESULTS FROM THE USE OF THE
INFORMATION PROVIDED IN THE SOFTWARE.
. Norwell, MA: Kluwer Academic Publishers 1996.
Implantable Cardioverter-Defibrillator
. Armonk, NY: Futura Publishing Co. 1998.
. New York, NY: Marcel Dekker,
Implantable
Implantable
. Armonk,
Nonpharmacological
13
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
Quick overview
Part I
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
1Quick reference
1.1 New to Intrinsic18
1.2 Physical characteristics18
1.3 Magnet application20
1.4 Longevity projections21
1.5 Replacement indicators23
1.6 Typical charge times23
1.7 High voltage therapy energy24
1.8 Stored data and diagnostics26
1
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
18
Chapter 1
New to Intrinsic
1.1New to Intrinsic
MVP (Managed Ventricular Pacing) – The MVP modes promote
intrinsic conduction by reducing unnecessary right ventricular
pacing. The MVP modes are indicated by AAIR<=>DDDR and
AAI<=>DDD on the mode selection screen. These modes
provide atrial-based pacing with ventricular backup. For loss of
AV conduction, the device switches to DDDR or DDD mode.
Periodic checks are performed, and if AV conduction resumes,
the device switches back to AAIR or AAI mode.
Measurements are nominal values based on CAD (computer aided design)
model measurements and are rounded to the nearest unit.
b
Grommets may protrude slightly beyond the can surface.
c
Engineering series number follows the radiopaque code.
d
These materials have been successfully tested for the ability to avoid biological
incompatibility. The device does not produce an injurious temperature in the
surrounding tissue.
Table 1-2. Lead connections
Device portConnector typeSoftware name
SVCDF-1HVX
RVDF-1HVB
Cann/aHVA; Can
VIS-1 bipolar
AIS-1 bipolar
sensing, Two DF-1 connectors for high
voltage therapy, Active Can electrode
(programmable)
—
—
19
Figure 1-1. Lead connections
1 DF-1 connector port, SVC (HVX)
2 DF-1 connector port, RV (HVB)
3 Device Active Can electrode, Can (HVA)
4 IS-1 connector port, V
5 IS-1 connector port, A
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
20
Chapter 1
Magnet application
Figure 1-2. Suture holes
1.3Magnet application
Bringing a magnet close to the device triggers changes in device
operation as shown in Table 1-3. When the magnet is removed,
the device returns to its programmed operations.
Table 1-3. 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
b
c
a
b
with programmable alerts enabled:
continuous tone (Test)
•
on/off intermittent tone (seek
•
follow-up)
high/low dual tone (urgent
•
follow-up)
with programmable alerts disabled:
no tone
•
high/low dual tone (urgent
•
follow-up)
Rate response adjustments are suspended while a Patient Alert tone sounds.
Detection resumes if telemetry is established and the application software is
running, or it resumes after the application software has started.
The Test tone does not sound if “VF Detection/Therapy Off” is the only alert
enabled.
c
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
1Quick reference
Longevity projections
1.4Longevity projections
1.4.1Intrinsic Model 7288 longevity projections
Longevity estimates are based on accelerated battery discharge
data and device modeling with EGM pre–storage off and a
60 ppm pacing rate. The estimates provided in Table 1-4 apply to
a delivered therapy energy of 35 J and pacing pulses having a
0.4 ms pulse width and either a 2.5 V or 3 V amplitude.
This model assumes default automatic capacitor formation
setting. As a guideline, each full-energy charge decreases device
longevity by approximately 31 days.
Table 1-4. Intrinsic Model 7288: Projected longevity in years with 0.4 ms pulse width and 60 ppm
pacing rate
Maximum
Pacing
DDD, 0%
energy charging
frequency
a
Semi-annualOff
Pre-arrhythmia
EGM storage
On
QuarterlyOff
On
DDD, 50%
Semi-annualOff
On
QuarterlyOff
On
AAI<=>DDD
(MVP mode),
50% atrial,
5% ventricular
Semi-annualOff
On
QuarterlyOff
On
DDD, 100%
Semi-annualOff
On
QuarterlyOff
On
a
Maximum energy charging frequency may include full-energy therapy shocks or capacitor formations.
b
The data provided for programming Pre-arrhythmia EGM on is based on a 6 month period (two 3 month
follow-up intervals) over the life of the device. Additional use of Pre-arrhythmia EGM reduces longevity by
approximately 27% or 3 months per year.
500pacing
impedance
b
2.5 V3.0 V2.5 V3.0 V
8.58.58.58.5
8.38.38.38.3
7.17.17.17.1
7.07.07.07.0
7.47.17.97.6
7.26.9
6.46.16.76.5
6.26.06.56.4
7.67.47.97.8
7.47.2
6.56.46.76.6
6.46.26.66.5
6.66.17.36.9
6.45.97.26.8
5.7
5.46.36.0
5.65.26.25.9
900pacing
impedance
7.7
7.7
7.4
7.6
21
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
22
Chapter 1
Longevity projections
1.4.2Intrinsic 30 Model 7287 longevity projections
Longevity estimates are based on accelerated battery discharge
data and device modeling with EGM pre–storage off and a
60 ppm pacing rate. The estimates provided in Table 1-5 apply to
a delivered therapy energy of 30 J and pacing pulses having a
0.4 ms pulse width and either a 2.5 V or 3 V amplitude.
This model assumes default automatic capacitor formation
setting. As a guideline, each full-energy charge decreases device
longevity by approximately 24 days.
Table 1-5. Intrinsic 30 Model 7287: Projected longevity in years with 0.4 ms pulse width and
60 ppm pacing rate
Maximum
Pacing
DDD, 0%
energy charging
frequency
a
Semi-annualOff
Pre-arrhythmia
EGM storage
On
QuarterlyOff
On
DDD, 50%
Semi-annualOff
On
QuarterlyOff
On
AAI<=>DDD
(MVP mode),
50% atrial,
5% ventricular
Semi-annualOff
On
QuarterlyOff
On
DDD, 100%
Semi-annualOff
On
QuarterlyOff
On
a
Maximum energy charging frequency may include full-energy therapy shocks or capacitor formations.
b
The data provided for programming Pre-arrhythmia EGM on is based on a 6 month period (two 3 month
follow-up intervals) over the life of the device. Additional use of Pre-arrhythmia EGM reduces longevity by
approximately 25% or 3 months per year.
500pacing
impedance
b
2.5 V3.0 V2.5 V3.0 V
8.68.68.68.6
8.58.58.58.5
7.57.57.57.5
7.37.37.37.3
7.5
7.28.07.8
7.47.07.97.6
6.66.47.06.8
6.56.26.86.7
7.87.68.17.9
7.67.47.97.8
6.86.77.06.9
6.76.56.96.8
6.76.2
6.56.07.37.0
6.0
5.5
5.85.46.46.1
900pacing
impedance
7.5
7.1
6.66.3
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
1.5Replacement indicators
Battery voltage and messages about replacement status appear
on the programmer display and on printed reports. Table 1-6 lists
the Elective Replacement Indicator (ERI) and the End of Life
(EOL) conditions.
Table 1-6. Replacement indicators
Elective Replacement (ERI)≤ 2.62 V
End of Life (EOL)3 months after ERI
ERI date – The programmer displays the date when the
battery reached ERI on the Quick Look and Battery and Lead
Measurements screens.
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,
ERI or EOL indicator may be displayed. However, this is a
temporary status which 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
23
Post-ERI conditions – EOL device status is defined as three
months following an ERI indication assuming the following
post-ERI conditions: 100% DDD pacing at 60 ppm, 3 V, 0.4 ms;
pacing load; and six full-energy charges. EOL may be
500
indicated before the end of three months if the device exceeds
these conditions.
1.6Typical 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 1-7 and Table 1-8).
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
24
Chapter 1
High voltage therapy energy
Table 1-7. Intrinsic Model 7288: typicalafull energy charge times
At Beginning of Life (BOL)
At Elective Replacement (ERI)
a
These charge times are typical when the capacitors are fully formed.
Table 1-8. Intrinsic 30 Model 7287: typicalafull energy charge times
At Beginning of Life (BOL)
At Elective Replacement (ERI)
a
These charge times are typical when the capacitors are fully formed.
1.7High 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 1-9 compares the programmed energy
levels delivered by the Intrinsic to the energy levels stored in
the capacitors before delivery. Table 1-10 makes the same
comparison for the Intrinsic 30 device.
7.0 s
8.9 s
5.9 s
7.5 s
Table 1-9. Intrinsic Model 7288: delivered (programmed) and stored energy levels
Energy ( J)
Delivereda/
ProgrammedStored
35397.0
32376.4
30346.0
28325.6
26305.2
25295.0
24274.8
22254.4
20234.0
18213.6
16193.2
15173.0
14162.8
13152.6
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
b
Charge
Timec( s)
Delivereda/
ProgrammedStored
Energy ( J)
b
10122.0
910.51.8
89.31.6
7
67.11.2
5
44.80.8
33.60.6
22.40.4
1.82.20.4
1.62.00.3
1.41.70.3
1.21.50.2
1.01.20.2
8.21.4
5.91.0
Charge
Timec( s)
1Quick reference
High voltage therapy energy
Table 1-9. Intrinsic Model 7288: delivered (programmed) and stored energy levels (continued)
25
Energy ( J)
Delivereda/
ProgrammedStored
12142.4
11132.2
b
Charge
Timec( s)
Delivereda/
ProgrammedStored
Energy ( J)
Charge
b
Timec( s)
0.81.00.2
0.60.80.1
0.40.50.1
a
Energy delivered at connector block into a 75
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 a second.
load.
Table 1-10. Intrinsic 30 Model 7287: delivered (programmed) and stored energy levels
Energy ( J)
Delivereda/
ProgrammedStored
b
Charge
Timec( s)
Delivereda/
ProgrammedStored
30355.9
28335.6
26315.2
24284.7
22264.4
20244.0
18213.5
16193.2
15183.0
14162.7
13152.5
12142.4
11132.2
10122.0
9111.9
a
Energy delivered at connector block into a 75
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 a second.
Table 1-11. Stored data and diagnostics (continued)
1Quick reference
Stored data and diagnostics
27
Battery and lead measurementsBattery voltage, last capacitor formation, last charge, lead
Lead performance trends14 days of daily measurements plus 80 weeks of weekly
Cardiac Compass trends14 months of measurement trends:
impedance, EGM amplitude measurements, last high
voltage therapy, and sensing integrity counter
minimum and maximum measurements:
Lead impedance: atrial pacing, ventricular pacing,
•
defibrillation pathway, and SVC lead (if used)
EGM amplitude: atrial (P-waves), ventricular
•
(R-waves)
VT and VF episodes per day
•
High voltage therapies delivered per day
•
Ventricular rate during VT or VF
•
Episodes of non-sustained tachycardia per day
•
Heart rate variability
•
Total daily time in AF or AT
•
Ventricular rate during AF or AT
•
Percent pacing per day
•
Patient activity
•
Average day and night ventricular heart rate
•
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
2The Intrinsic system
2.1 System overview30
2.2 Indications and usage33
2.3 Contraindications33
2.4 Patient screening33
2
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
30
Chapter 2
System overview
2.1System overview
The Intrinsic and Intrinsic 30 Dual Chamber Implantable
Cardioverter Defibrillator (ICD) systems are implantable medical
device systems that automatically detect and treat episodes of
ventricular fibrillation, ventricular tachycardia, fast ventricular
tachycardia, and bradyarrhythmia. The device system includes
three major components:
ICD
•
The ICD senses the electrical activity of the patient’s heart
via the sensing electrodes of the implanted atrial and
ventricular leads. It then analyzes the heart rhythm based
on selectable sensing and detection parameters. If the
device detects a tachyarrhythmia, it delivers defibrillation,
cardioversion, or antitachycardia pacing therapy to the
patient’s heart. If the device identifies a bradyarrhythmia, it
delivers bradycardia pacing therapy to the patient’s heart.
Leads
•
The ICD can be used with transvenous or epicardial
defibrillation leads. The lead system should consist
of bipolar or paired unipolar1pacing/sensing leads in
each chamber of the hear t and one or two high voltage
cardioversion/defibrillation electrodes. You can program
the Active Can device case as a high voltage electrode.
The pacing and sensing electrodes in each chamber sense
cardiac activity and deliver pacing stimuli.
Programmer and software
•
The Medtronic programmer and application software (Model
9997 for Intrinsic and Model 9996 for Intrinsic 30) allow you
to perform the following tasks:
– configure the detection, therapy, and bradycardia features
for your patient
– perform electrophysiological studies and system tests
– monitor, display, or print patient cardiac activity
information
– view patient and device diagnostic data
1
With an appropriate unipolar to bipolar adapter kit.
INTRINSIC™/INTRINSIC™30 7288/7287Reference Manual
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