GEM®III DR 7275
Dual Chamber Implantable Cardioverter Defibrillator
System Reference Guide
1
GEM® III DR
System Reference Guide
Caution: Federal Law (USA) restricts this
device to sale by or on the order of a
physician.
A guide to the operation and
programming of the 7275
®
GEM
Implantable Cardioverter
Defibrillator
III DR Dual Chamber
GEM, Marker Channel, Decision Channel, PR Logic, T-Shock, Quick Look, QuickLink, Patient Alert,
Active Can, and Flashback are trademarks of Medtronic, Inc.
Table of Contents
Table of Contents
Introduction vii
Abbreviations and Acronyms ix
1. Quick Reference
Primary Capabilities 1-2
Physical Characteristics 1-5
Electrical Characteristics 1-6
Magnet Application 1-10
Emergency Settings 1-11
Programmable Parameters Overview 1-12
Detection Parameters 1-13
Therapy Parameters 1-15
Bradycardia Pacing Parameters 1-17
Automatic Capacitor Formation Parameters 1-19
Data Collection Parameters 1-20
Patient Alert™ Monitoring System Parameters 1-21
Patient Information Parameters 1-23
EP Studies Parameters 1-24
Fixed Parameters 1-26
Notes 1-28
2. Emergency Therapy
Overview 2-2
Effect on System Operation 2-3
On-Screen and Display Panel Buttons 2-3
Emergency Defibrillation 2-4
Emergency Cardioversion 2-5
Emergency Fixed Burst Pacing 2-6
Emergency VVI Pacing 2-7
3. Overview
System Description 3-2
Detection and Therapy Overview 3-4
Disabling Detection and Therapies 3-9
4. Tachyarrhythmia Detection
Sensing 4-2
VF Detection 4-7
VT Detection 4-10
Combined Count Detection 4-13
VT Stability Option 4-15
GEM®III DR System Reference Guide
iii
Table of Contents
FVT Detection 4-17
Dual Chamber SVT Criteria 4-22
Termination and Redetection 4-35
5. Tachyarrhythmia Therapies
High Voltage Therapy Overview 5-2
Defibrillation 5-9
Cardioversion 5-17
Antitachycardia Pacing Therapy Overview 5-23
Programming ATP Therapies 5-25
Burst Pacing 5-27
Ramp Pacing 5-29
Ramp+ Pacing 5-31
Smart Mode 5-33
Progressive Episode Therapies 5-36
6. Bradycardia Pacing
Pacing Mode 6-2
Bradycardia Pacing Parameters 6-9
Post Shock Pacing Parameters 6-22
Mode Switch 6-25
Rate Responsive Pacing 6-29
Rate Adaptive AV 6-35
Non-Competitive Atrial Pacing 6-38
Single Chamber Hysteresis 6-42
Ventricular Rate Stabilization 6-44
PVC Response 6-47
PMT Intervention 6-49
Ventricular Safety Pacing 6-51
7. Programmer and Software
Connecting the Programmer Hardware 7-2
Setting Up and Using the Programmer 7-12
Using the Programmer Display Screen 7-22
Starting a Patient Session 7-30
Programming Parameter Values 7-32
Checklist 7-35
Live Rhythm Monitor 7-42
Recording Live Waveforms 7-54
Printing Reports 7-62
Changes This Session 7-67
Ending a Patient Session 7-68
iv
GEM®III DR System Reference Guide
8. Conducting System Tests
System Tests Overview 8-2
Underlying Rhythm Test 8-3
Pacing Threshold Test 8-4
Lead Impedance Test 8-6
Manual EGM Amplitude Test 8-9
Test Charge / Dump 8-11
Capacitor Formation 8-13
9. EP Studies
EP Studies Overview 9-2
Delivering Inductions 9-6
T-Shock™
50 Hz Burst Induction 9-9
Manual Burst Induction 9-10
PES Induction 9-11
Delivering Manual Therapies 9-12
Manual Defibrillation Therapy 9-13
Manual Cardioversion Therapy 9-14
Manual ATP (Antitachycardia Pacing) Therapies 9-14
10. Data Collection
Data Collection Overview 10-2
Quick Look™ 10-4
Setting Up Data Collection 10-6
Counter Data 10-11
Episode Data 10-15
Patient Information 10-28
Battery and Lead Measurements 10-32
Device Status Indicators 10-36
Saving and Retrieving ICD Data 10-38
Induction 9-8
Table of Contents
11. Patient Alert™ Monitoring System
Patient Alert™ Monitoring System 11-2
Instructions for the Patient 11-7
Instructions for Clinic Personnel 11-9
Patient Alert™ Event Log 11-10
12. Implant and Follow-up
Pre-Implant Information 12-2
Operative Set-Up 12-4
Surgical Approach 12-6
Sensing and Pacing Measurements 12-8
Defibrillation Testing 12-9
GEM®III DR System Reference Guide
v
Table of Contents
Placing the ICD 12-15
Replacing the ICD 12-16
Pre-Discharge Evaluation 12-17
Follow-Up Recommendations 12-18
A. Appendix A - Warnings and Precautions
General Warnings A-2
Sterilization, Storage, and Handling A-3
Implantation and ICD Programming A-4
Lead Evaluation and Lead Connection A-5
Follow-up Testing A-6
ICD Explant and Disposal A-7
Environmental and Medical Therapy Hazards A-7
Home and Occupational Environments A-10
B. Appendix B - Parameter Interlocks
Bradycardia Pacing Parameter Interlocks B-2
Detection Parameter Interlocks B-6
Resolving Tachy / Brady Parameter Interlocks B-8
G. Glossary
I. Index
vi
GEM®III DR System Reference Guide
Introduction
Introduction
Before implanting the ICD, it is strongly recommended that you:
■
Refer to the product literature packaged with the ICD for information
about prescribing the ICD.
■
Thoroughly read this manual and the technical manuals for the leads
used with the device.
■
Discuss the procedure and the ICD system with the patient and any
other interested parties, and provide them with any patient
information packaged with the ICD.
Education
Medtronic invites physicians to attend an education seminar on the
complete ICD system. The course includes indications for use, an
overview of ICD system functions, implant procedures, and
patient management.
Technical Support
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 medical consultation,
Medtronic can often refer product users to outside medical consultants
with appropriate 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.
GEM®III DR System Reference Guide
vii
Introduction
References
Automatic defibrillation was invented and patented in 1953 by Dr. F.
Zacouto, who designed an external device that delivered a defibrillation
impulse to the heart upon detection of very rapid ECG activity in
combination with the absence of arterial pulsations.
The primary reference for background information is Zacouto FI, Guize LJ.
Fundamentals of Orthorhythmic Pacing. In: Luderitz B, ed.
Pacing Diagnostic and Therapeutic Tools.
New York: Springer-Verlag;
1976: 212-218.
See these additional references for more background information:
■
Singer I, Ed.
Implantable Cardioverter-Defibrillator
Futura Publishing Co. 1994.
■
Singer I, Barold SS, Camm AJ, Eds.
Nonpharmacological Therapy of
Arrhythmias for the 21st Century: The State of the Art
Futura Publishing Co. 1998.
■
Estes M, Manolis AS, Wang P, Eds.
Cardioverter-Defibrillators
■
Kroll MW, Lehmann MH, Eds.
. New York, NY: Marcel Dekker, Inc. 1994.
Therapy: The Engineering-Clinical Interface
Implantable
Implantable Cardioverter-Defibrillator
. Norwell, MA: Kluwer
Academic Publishers 1996.
Cardiac
. Armonk, NY:
. Armonk, NY:
viii
Notice
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, INCIDENTIAL OR
CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH
RESULTS FROM THE USE OF THE INFORMATION PROVIDED IN THE
SOFTWARE.
GEM®III DR System Reference Guide
Abbreviations and Acronyms
A- Atrial
AF Atrial Fibrillation
AFib/AFlutter Atrial Fibrillation and/or Atrial Flutter
ARP Atrial Refractory Period
ATP Antitachycardia Pacing
AVP Atrial Vulnerable Period
BOL Beginning of Life
bpm beats per minute
CNID Combined (VT and VF) Number of Intervals to Detect
CV Cardioversion
DF / Defib Defibrillation
ECG Electrocardiogram
EGM Electrogram
EOL End of Life
ERI Elective Replacement Indicator
FDI Fibrillation Detection Interval
FTI Fast Ventricular Tachycardia Detection Interval
FVT Fast Ventricular Tachycardia
ICD Implantable Cardioverter-Defibrillator
J joules
-1
min
ms milliseconds
mV millivolts
NCAP Non-Competitive Atrial Pacing
NID Number of Intervals to Detect
PAC Premature Atrial Contraction
PAV Paced A-V Delay
PES Programmed Electrical Stimulation
PMT Pacemaker-Mediated Tachycardia
POR Power On Reset
PP P-P interval; an atrial interval
ppm paces or pulses per minute
reciprocal minutes; for example, pacing pulses per minute
Abbreviations and Acronyms
GEM®III DR System Reference Guide
ix
Abbreviations and Acronyms
PR P-R interval; an interval between a P-wave and the
PVAB Post Ventricular Atrial Blanking period
PVARP Post Ventricular Atrial Refractory Period
PVC Premature Ventricular Contraction
RAAV Rate Adaptive A-V delay
RCNID Combined (VT and VF) Number of Intervals to Redetect
RNID Number of Intervals to Redetect
RP R-P interval; an interval between an R-wave and the
RR R-R interval; a ventricular interval
SAV Sensed A-V Delay
ST / Sinus Tach Sinus Tachycardia
SVT Supraventricular Tachycardia
TDI Tachycardia Detection Interval
V volts
V- Ventricular
VF Ventricular Fibrillation
VF NID VF Number of Intervals to Detect
VF RNID VF Number of Intervals to Redetect
VRS Ventricular Rate Stabilization
VSP Ventricular Safety Pacing
VT Ventricular Tachycardia
VT NID VT Number of Intervals to Detect
VT RNID VT Number of Intervals to Redetect
subsequent R-wave
subsequent P-wave
x
GEM®III DR System Reference Guide
Quick Reference
1
1
Primary Capabilities 1-2
Physical Characteristics 1-5
Electrical Characteristics 1-6
Magnet Application 1-10
Emergency Settings 1-11
Programmable Parameters
Overview 1-12
Detection Parameters 1-13
Therapy Parameters 1-15
Bradycardia Pacing
Parameters 1-17
Automatic Capacitor
Formation Parameters 1-19
Data Collection Parameters 1-20
Patient Alert™ Monitoring
System Parameters 1-21
Patient Information
Parameters 1-23
EP Studies Parameters 1-24
Fixed Parameters 1-26
Notes 1-28
GEM®III DR System Reference Guide
1-1
Quick Reference
Primary Capabilities
Primary Capabilities
Pacing Management
Dual chamber rate responsive bradycardia pacing up to
150 ppm (min
Rate Adaptive AV, Sensor Varied PVARP, PMT Intervention,
Non-Competitive Atrial Pacing, Ventricular Safety Pacing
Ventricular Rate Stabilization after short ventricular intervals
DDIR Mode Switch during paroxysmal atrial episodes
-1
): DDDR, DDD, DDIR, DDI, VVIR, VVI, AAIR, AAI modes;
Dual Chamber VF/VT/FVT Detection
Ventricular fibrillation and ventricular tachycardia detection
(VF, VT, and FVT)
Single chamber VT Stability criterion
PR Logic™ Pattern and Rate Analysis identifies Atrial Fibrillation/Atrial
Flutter, Sinus Tachycardia, and Other 1:1 SVTs
Adjustable 1:1 VT-ST Boundary for patients with slow conduction
Tachyarrhythmia Therapy
Up to six (each) automatic VF, VT, and FVT therapies
Ventricular defibrillation and cardioversion, 30 joules delivered (35 joules
stored) with 50% tilt
1-2
Burst, Ramp, and Ramp+ antitachycardia pacing
Smart Mode disables ineffective ATP therapies
Progressive Episode Therapies ensures increasingly aggressive therapy
sequencing
Dual chamber synchronization of high voltage therapies avoids the
atrium’s vulnerable period
GEM®III DR System Reference Guide
Quick Reference
Primary Capabilities
Patient Management
Audible Patient Alert™ monitoring system
Automatic, painless pacing and HV lead impedance testing
Lead performance trends report and display
Sensing integrity counter
Patient information that can be entered, viewed and printed via
the programmer
Two simultaneous real time EGMs: atrial / ventricular / far-field
Two channels stored EGM: atrial / ventricular / far-field
Dual chamber Marker Channel™ telemetry
Supplementary Decision Channel annotations in stored EGM and on real
time recordings that indicate detection algorithm status.
256 Kbyte data storage, including two EGMs, Markers, and Flashback™
Memory of A-A and V-V intervals
Save-to-Disk and Read-from-Disk patient data features
Table 1-1. GEM®III DR ICD Data Collection Summary
Tachy episodes
SVT/NST episodesa50 SVT/NST episodes: text, stored EGM, intervals, and
Brady episodes 53 mode switch episodes: episode text
EGM capacity 12 minutes (2 channels) or 22 minutes (1 channel)
EGM sources Ten options: atrial / ventricular / far-field
EGM options Store before onset; Store during charging
Flashback™
Memory
Detection counters Lifetime total, Since cleared, and Since last session
a
150 VF/VT/FVT episodes: text, stored EGM, intervals
episode summaries (usually only episode summaries are
provided for NSTs)
2000 intervals (containing both A-A and V-V): before latest
VF, before latest VT, and before interrogation
GEM®III DR System Reference Guide
1-3
Quick Reference
Primary Capabilities
Table 1-1. GEM®III DR ICD Data Collection Summary
Episode counters Episodes:
- VF, FVT, and VT
- Atrial Fibrillation / Atrial Flutter episodes
- Sinus Tach episodes
- Other 1:1 SVTs episodes
- Non-sustained tachy 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
Therapy Efficacy
Counters
Patient Alert™
Events
a
All tachy, NST, and SVT episode data are stored in the same block of memory.
Counts for each VF, FVT, VT Therapy:
- Delivered
- Successful
- Unsuccessful
- Intervention
Total number of aborted shocks
Up to 10 log entries: text and date for the first time an alert
is triggered between interrogations.
Other features
1-4
Direct replacement for DF-1 / IS-1 systems, including all Medtronic “C,”
“Cx,” and “D” ICDs
Medtronic icon-based user interface
Full-size report printing
Quick Look™ programming summary with Quick Links™ to stored
episodes and observations
Non-invasive EP study functions: atrial inductions, ventricular inductions /
manual therapies
Smart Auto Cap Formation extends the formation timer after
therapeutic charging
Auto-Resume feature automatically resumes detection after an induction
Checklist feature provides streamlined, customizable navigation through
sets of tasks for follow-up and implant visits
GEM®III DR System Reference Guide
Physical Characteristics
Volume 39.7 cc
Mass 78.1 g
H x W x D
Surface area of device can 69.0 cm
a
Quick Reference
Physical Characteristics
70.1 mm x 50.8 mm x 13.5 mm
2
Radiopaque ID
Materials in contact with
human tissue
b
c
PJM
Titanium / polyurethane / silicone rubber
Battery Lithium silver vanadium oxide
Connector configuration Two IS-1 connectors for pacing and sensing,
Two DF-1 connectors for high voltage therapy,
Active Can® electrode
A
IS-1
V
SVC
(HVX)
RV
(HVB)
DF-1
Can (HVA)
a
This measurement refers to the thickness (depth) of the can; grommets may protrude slightly
beyond can surface.
b
Engineering series number follows the radiopaque code.
c
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.
GEM®III DR System Reference Guide
1-5
Quick Reference
Electrical Characteristics
Electrical Characteristics
Longevity
Table 1-2 below provides longevity estimates based on accelerated
battery discharge data and device modeling with 60 ppm (min-1) pacing
rate, 2 V pacing pulse amplitude, 0.6 ms pacing pulse width, and
30 J delivered therapy energy
Table 1-2. GEM®III DR Projected Longevity in Years with 2 V Pacing Pulse Amplitude
and 0.6 ms Pacing Pulse Width
Percent
pacing
0% Semi-Annual 7.0 7.0 7.0 7.0
15% Semi-Annual 6.7 6.9 6.8 7.0
50% Semi-Annual 6.1 6.6 6.5 6.8
100% Semi-Annual 5.5 6.2 6.1 6.5
Maximum Energy
Charging Frequency
Quarterly 6.3 6.3 6.3 6.3
Quarterly 6.0 6.2 6.1 6.3
Quarterly 5.6 6.0 5.9 6.1
Quarterly 5.1 5.7 5.5 6.0
1
.
500 ohm pacing
impedance
DDD Pacing VVI Pacing DDD Pacing VVI Pacing
900 ohm pacing
impedance
1-6
GEM®III DR System Reference Guide
Quick Reference
Electrical Characteristics
Table 1-3 below provides longevity estimates based on accelerated
battery discharge data and device modeling with 60 ppm (min-1) pacing
rate, 3 V pacing pulse amplitude, 0.4 ms pacing pulse width, and
30 J delivered therapy energy
Table 1-3. GEM®III DR Projected Longevity in Years with 3 V Pacing Pulse Amplitude
and 0.4 ms Pacing Pulse Width
Percent
pacing
0% Semi-Annual 7.0 7.0 7.0 7.0
15% Semi-Annual 6.4 6.7 6.6 6.9
50% Semi-Annual 5.5 6.2 6.0 6.5
100% Semi-Annual 4.5 5.5 5.3 6.1
Maximum Energy
Charging Frequency
DDD Pacing VVI Pacing DDD Pacing VVI Pacing
Quarterly 6.3 6.3 6.3 6.3
Quarterly 5.8 6.0 6.0 6.2
Quarterly 5.0 5.6 5.5 5.9
Quarterly 4.2 5.1 4.9 5.5
1
.
500 ohm pacing
impedance
900 ohm pacing
impedance
The following factors result in decreased longevity:
■
an increase in pacing rate, pacing amplitude or pulse width, the ratio
of bradycardia paced to sensed events, or the charging frequency,
■
a decrease in pacing impedance, or
■
using the pre-onset EGM storage feature or Holter telemetry
To maximize ICD longevity:
■
Optimize pacing rate and output parameters for the patient.
■
Set the delivered energy value for the first programmed high voltage
therapy to a value lower than maximum energy.
■
Set the automatic capacitor formation interval to a longer value
(unless a shorter interval is required to maintain clinically acceptable
charge times).
■
Use the pre-onset EGM storage feature and Holter telemetry only for
short periods of time.
1
EGM pre-storage feature set to Off.
GEM®III DR System Reference Guide
1-7
Quick Reference
Electrical Characteristics
Battery Voltage
Battery voltage appears on the programmer display and on printed
reports. See “Preparing the ICD for Implant” on page 12-5, and
“Replacement Indicators” on page 12-19 for more information.
Table 1-4. Battery Voltage Indicators
Elective Replacement (ERI)
Pacing mode and rate (magnet and non-magnet) as programmed
End of Life (EOL)
Pacing mode and rate (magnet and non-magnet) as programmed
a
The minimum time between ERI and End of Life is three months, assuming 100% DDD
pacing at 60 ppm (min
b
When the battery reaches EOL, immediate replacement is recommended. (See also “Charge
Circuit Timeout” on page 5-4.)
b
-1
a
), 3 V, 0.4 ms; 500 Ω pacing load; and six 30 J charges.
≤ 2.55 V
≤ 2.40 V
Charge Time
The high voltage capacitors charge more rapidly just following a capacitor
formation, when they are fully formed. Between formations, the capacitors
gradually deform, resulting in longer charge times toward the end of the
formation interval. See page 8-13 for information on managing charge
time. See page 8-12 for instructions on using the Test Charge feature to
measure charge time. Table 1-5 provides typical full energy charge times
at BOL and ERI based on the time interval since the last capacitor
formation.
Table 1-5. Typical Full Energy (30 J Delivered) Charge Times
Capacitors
fully formed
At Beginning of Life (BOL) 7 seconds ≈ 1 second
Near Elective Replacement
Indicator (ERI)
a
Typical values for stated conditions, actual charge time performance may vary.
14 seconds ≈ 3 seconds
3 months after
capacitor
formation
longer than fully
formed
longer than fully
formed
a
6 months after
capacitor
formation
≈ 2 seconds
longer than fully
formed
≈ 5 seconds
longer than fully
formed
1-8
GEM®III DR System Reference Guide
Quick Reference
Electrical Characteristics
High Voltage Therapy Energy
Table 1-5 compares delivered energy levels to energy levels stored by the
device.
Note: 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 1-6. Comparing Programmed (Actual Delivereda) and Storedb Energy Levels
Programmed
(Actual Delivered)
Energy (J)
0.4 0.5 .09 9 11 1.94
0.6 0.8 .13 10 12 2.15
0.8 1.0 .17 11 13 2.37
1.0 1.2 .22 12 14 2.58
1.2 1.5 .26 13 15 2.80
1.4 1.7 .30 14 16 3.01
1.6 2.0 .34 15 18 3.23
1.8 2.2 .39 16 19 3.44
2 2.4 .43 18 21 3.87
3 3.6 .65 20 24 4.30
4 4.7 .86 22 26 4.73
5 5.9 1.08 24 28 5.16
6 7.1 1.29 26 31 5.59
7 8.3 1.51 28 33 6.02
8 9.4 1.72 30 35 6.45
a
Energy and voltage delivered at connector block into a 75 ohm load.
b
Energy stored at end of charge on capacitor.
c
Typical charge time at BOL, with fully formed capacitors.
Stored
Energy (J)
Charge
Timec (sec)
Programmed
(Actual Delivered)
Energy (J)
Stored
Energy (J)
Charge
Timec (sec)
GEM®III DR System Reference Guide
1-9
Quick Reference
Magnet Application
Magnet Application
Applying a magnet closes a reed switch within the ICD (see Table 1-6 for
magnet effects). When the magnet is removed, the ICD returns to its
programmed operations.
Pacing Mode as programmed
Pacing Rate and Interval as programmed
VF, VT, and FVT Detection
and Therapy
Patient Alert™ Audible Tones
a
The programming head contains a magnet which can suspend detection. However, if the
Resume option has been enabled via the programmer, detection will remain enabled.
b
The alert sounds only if Patient Alert™ is programmed On for any alert except POR. A POR
alert causes an alarm every 20 hours, even if Patient Alert is programmed Off.
Table 1-7. Effects of Magnet Application
suspended
b
(30 seconds or less)
continuous tone (Alarm OK)
on/off intermittent tone (seek follow-up)
high/low dual tone (urgent follow-up)
a
1-10
GEM®III DR System Reference Guide
Emergency Settings
The table below lists the values that can be selected for the ICD
emergency therapy parameters. Default values are highlighted in
bold, italicized
notes on page 1-28.
Table 1-8. Emergency Therapy Parameters
Parameter Selectable Values (and
Defibrillation
Energy (J) 10, 11, . . ., 16,
18, 20, . . .,
Pathway AX→B
Cardioversion
Energy (J) 0.4, 0.6, . . ., 1.8,
2, 3, . . ., 16
18, 20, . . .,
Pathway AX→B
Fixed Burst
Pacing Interval (ms) 100, 110, . . .,
360, 370, . . ., 600
Pulse Amplitude (V) 8
Pulse Width (ms) 1.6
text. The Notes column lists letters than correspond to
30
30
350
,
default value
Quick Reference
Emergency Settings
) Notes
VVI Pacing
Pacing Mode VVI
Lower Rate (ppm, min-1)70
Vent. Rate Stabilization Off
Hysteresis Off
V. Sensitivity/A.Sensitivity As programmed
Pulse Amplitude (V) 6 V
Pulse Width (ms) 1.6 ms
Pace Blanking (ms) 240 ms
Post Shock Pace Blanking (ms) 240 ms A.
GEM®III DR System Reference Guide
1-11
Quick Reference
Programmable Parameters Overview
Programmable Parameters Overview
The tables that follow (from “Detection Parameters” on page 1-13 to
“Patient Information Parameters” on page 1-23) list the values that can be
selected for all ICD programmable parameters. As applicable, these
tables also indicate the Medtronic nominal value, the POR value, and the
shipped value for each parameter.
Medtronic nominal values – are suggested settings for parameters
under nominal conditions. Medtronic nominal values, if applicable, are
indicated in the Programmable Values column with
POR values – are the values to which the ICD resets parameters after a
power-on reset (POR). If a POR occurs, the ICD sounds a high-urgency
Patient Alert™ tone every twenty hours. See the “Power-On Reset
Recovery Procedure” on page 10-37.
Shipped values – are the programmed parameter values when the ICD
is shipped from Medtronic.
The Notes column in each table lists letters that correspond to notes on
page 1-28. These include exceptions or clarifications that relate to the
values listed in the programmable parameter tables.
bold, italicized
text.
1-12
GEM®III DR System Reference Guide
Detection Parameters
Table 1-9. Detection Parameters (Sheet 1 of 2)
Parameter Programmable Values
VF DETECTION PARAMETERS
Detection Enable
Interval (ms) 240, 250, . . .,
Initial NID 12/16,
Redetect NID 6/8, 9/12,
V. Sensitivity (mV) 0.15,
A. Sensitivity (mV) 0.15,
(and
Medtronic Nominal
On
, Off On Off
320
,
330, 340, . . ., 400
18/24
12/16
0.3
, 0.45, 0.6,
0.3
, 0.45, 0.6,
, 24/32,
, 18/24,
30/40, 45/60, 60/80,
75/100, 90/120,
105/140, 120/160
21/28, 24/32, 27/36, 30/40
0.9, 1.2
0.9, 1.2, 1.5, 2.1
Quick Reference
Detection Parameters
)
POR
Value
320 320 C.
18/24 18/24 B.
12/16 12/16
0.3 0.3 D, E.
0.3 0.3 D, E.
Shipped
Value
Notes
FVT DETECTION PARAMETERS
Detection Enable
Interval (ms) 200, 210, . . ., 600 --- --- C, F.
V. Sensitivity (mV) 0.15,
A. Sensitivity (mV) 0.15,
Off
, via VF, via VT Off Off
0.3
0.9, 1.2
0.9, 1.2, 1.5, 2.1
, 0.45, 0.6,
0.3
, 0.45, 0.6,
0.3 0.3 D, E.
0.3 0.3 D, E.
GEM®III DR System Reference Guide
1-13
Quick Reference
Detection Parameters
Table 1-9. Detection Parameters (Sheet 2 of 2)
Parameter Programmable Values
VT DETECTION PARAMETERS
Detection Enable On,
Interval (ms) 280, 290, . . .,
Initial NID 12, 16, . . ., 52,
Redetect NID 4, 8, 12, . . ., 52 12 12
V. Sensitivity (mV) 0.15,
A.Sensitivity (mV) 0.15,
VT Stability Criterion Parameters
VT Stability (ms)
(and
Medtronic Nominal
)
Off
400
,
410, 420, . . ., 600
76, 100
0.3
0.9, 1.2
0.9, 1.2, 1.5, 2.1
Off
, 0.45, 0.6,
0.3
, 0.45, 0.6,
, 30, 40, . . ., 100 Off Off C.
POR
Value
Off Off
400 400 C.
16 16
0.3 0.3 D, E.
0.3 0.3 D, E.
Shipped
Value
Notes
DUAL CHAMBER SVT DETECTION
AFib / AFlutter
Sinus Tach
1:1 VT-ST Boundary (%) 35, 50, 66, 75, 85 50 50
Other 1:1 SVTs On,
SVT Limit (ms) 240, 250, . . .,
On
, Off Off Off H.
On
, Off Off Off H.
Off
320
330, 340, . . ., 600
,
Off Off
320 320 C, F.
I.
1-14
GEM®III DR System Reference Guide
Therapy Parameters
Table 1-10. Therapy Parameters (Sheet 1 of 2)
Parameter Programmable Values
VF THERAPY PARAMETERS
Therapy Status
Energy (J) 0.4, 0.6, . . ., 1.8,
Pathway
Reconfirm VF
VT and FVT THERAPY PARAMETERS
Cardioversion Therapy Parameters
Therapy Status
Energy (J) 0.4, 0.6, . . ., 1.8,
Pathway
(and
Medtronic Nominal
On
, Off On (all) On (all)
2, 3, . . ., 16,
18, 20, . . .,
AX→B
Yes
On
2, 3, . . ., 16,
18, 20, . . .,
AX→B
30
, B→AX AX→B (all) AX→B (all) J.
, No Yes Yes M.
, Off --- ---
30
, B→AX --- --- J.
Quick Reference
Therapy Parameters
)
POR
Value
30 (all) 30 (all) J, K, L.
--- --- J, L.
Shipped
Value
Notes
Burst Pacing Therapy Parameters
Therapy Status
Initial # Pulses 1, 2, . . ., 6, . . ., 15 --- --- J.
R-S1 Interval
(% of R-R)
Pacing Interval Decrement (ms) 0,
# Sequences 1, 2, 3, . . ., 10 --- ---
Smart Mode On,
On
, Off --- ---
50, 53, 56, 59,
63, 66, . . ., 84,
88, 91, 94, 97
10
, . . ., 40 --- ---
Off
--- --- J.
--- --- N.
GEM®III DR System Reference Guide
1-15
Quick Reference
Therapy Parameters
Table 1-10. Therapy Parameters (Sheet 2 of 2)
Parameter Programmable Values
Ramp Pacing Therapy Parameters
Therapy Status
Initial # Pulses 1, 2, . . ., 8, . . ., 15 --- --- J, AB.
R-S1 Interval
(% of R-R)
Pacing Interval Decrement (ms) 0, 10, . . ., 40 --- --- J.
# Sequences 1, 2, 3, . . ., 10 --- ---
Smart Mode On,
Ramp+ Pacing Therapy Parameters
Therapy Status
Initial # Pulses 1, 2, 3, . . ., 15 --- --- J.
R-S1 Interval
(% of R-R)
S1-S2 Interval
(% of R-R)
S2-Sn Interval
(% of R-R)
# Sequences 1, 2, . . ., 5, . . ., 10 --- ---
Smart Mode On,
(and
Medtronic Nominal
On
, Off --- ---
50, 53, 56, 59,
63, 66, . . ., 84,
88,91, 94, 97
)
Off
On
, Off --- ---
50, 53, 56, 59,
63, 66, . . ., 75, . . ., 84,
88, 91, 94, 97
50, 53, 56, 59,
63, 66, 69, . . ., 84,
88, 91, 94, 97
50, 53, 56, 59,
63,66, . . ., 84,
88, 91, 94, 97
Off
POR
Value
--- --- J, AB.
--- --- N.
--- --- J.
--- --- J.
--- --- J.
--- --- N.
Shipped
Value
Notes
SHARED PARAMETERS FOR TACHYARRHYTHMIA THERAPIES
Shared by all Automatic ATP Therapies J.
V. Pulse Width (ms) 0.03, 0.06,
V. Amplitude (V) 1, 2, . . ., 6,
V. Pace Blank (ms) 150, 160, . . .,
ATP Minimum Interval (ms) 150, 160, . . .,
Shared by all VF, VT, and FVT Therapies
Progressive Episode
Therapies Enable
1-16
GEM®III DR System Reference Guide
0.1, 0.2, . . .,
On,
Off
1.6
8
240
, . . ., 440 240 240
200
, . . ., 400 200 200
1.6 1.6
88
Off Off
Bradycardia Pacing Parameters
Bradycardia Pacing Parameters
Table 1-11. Bradycardia Pacing Parameters (Sheet 1 of 3)
Parameter Programmable Values
Pacing Mode
Lower Rate (ppm, min-1) 34, 35, 40, . . ., 60,
Upper Tracking Rate (ppm, min-1) 80, 85, . . ., 105,
Upper Sensor Rate
(ppm, min-1)
A. Sensitivity (mV) 0.15,
A. Pulse Width (ms) 0.03, 0.06,
A. Pulse Amplitude (V) 1, 2, 3, . . ., 6 4 3
A.Pace Blanking (ms) 200, 210, . . .,
V. Sensitivity (mV) 0.15,
V. Pulse Width (ms) 0.03, 0.06,
V. Pulse Amplitude (V) 1, 2,
V. Pace Blanking (ms) 150, 160, . . .,
(and
Medtronic Nominal
DDDR
, DDD, DDIR, DDI, AAIR,
AAI, VVIR, VVI
70, 75, . . ., 105,
109, 115, 120
109, 115,
146, 150
80, 85, . . ., 105,
109, 115,
146, 150
0.9, 1.2, 1.5, 2.1
0.1, 0.2, . . .,
0.5, 0.6, . . ., 1.6
120
, 125, 130, 136, 140,
120
, 125, 130, 136, 140,
0.3
, 0.45, 0.6,
0.4
,
240
0.3
0.9, 1.2
0.1, 0.2, . . .,
0.5, 0.6, . . . , 1.6
, 0.45, 0.6,
0.4
,
3
, . . ., 6 6 3
200
210, 220, . . ., 440
)
, 250 240 240
,
POR
Value
VVI DDD
65 60 G.
120 120 G.
120 120 G.
0.3 0.3 D, E.
0.4 0.4
0.3 0.3 D, E.
1.6 0.4
240 200
Quick Reference
Shipped
Value
Notes
Post-Shock Pacing Parameters
A. Pulse Width (ms) 0.03, 0.06,
A. Pulse Amplitude (V) 1, 2, 3, 4, 5, 6 4 4
A. Pace Blanking (ms) 200, 210, . . .,
V. Pulse Width (ms) 0.03, 0.06,
V. Pulse Amplitude (V) 1, 2, 3, 4, 5,
V. Pace Blanking (ms) 150, 160, . . .,
0.1, 0.2, . . .,
1.6
240
0.1, 0.2, . . .,
1.6
6
200
210, 220, . . ., 440
, 250 240 240
,
1.6 1.6
1.6 1.6
66
240 200
GEM®III DR System Reference Guide
1-17
Quick Reference
Bradycardia Pacing Parameters
Table 1-11. Bradycardia Pacing Parameters (Sheet 2 of 3)
Parameter Programmable Values
Intervals
PAV (ms) 30, 40, . . .,
SAV (ms) 30, 40, . . .,
PVARP (ms) Varied,
A. Refractory (ms) 150, 160, . . .,
PVAB (ms) 100, 110, . . .,
Mode Switch Parameters
Enable On,
A. Detect Rate (bpm, min-1) 120, 125, 130, 136, 140, 146, 150,
Rate Response Pacing Parameters
Rate Response 1, 2, . . ., 7,
Activity Threshold Low, Medium Low,
Activity Acceleration (sec.) 15,
Activity Deceleration (min.) Exercise, 2.5, 5, 10 5 5
(and
Medtronic Nominal
180
190, 200, . . ., 350
150
160, 170, . . ., 350
150, 160, . . .,
320, 330, . . ., 500
310
310
320, 330, . . ., 500
150
160, 170, . . ., 350
,
,
)
,
,
,
Off
154, 158, 167, 171,
8, 9, 10
Medium
Medium High, High
,
30
, 60 30 30
176
POR
Value
180 180
150 150
310 310 O.
310 310
150 150 O.
Off Off
176 176
77
High Medium
Shipped
Value
Notes
Rate Adaptive AV Parameters
Enable On,
Start Rate (bpm, min-1) 50, 55, 60, . . ., 105, 109,
Stop Rate (bpm, min-1) 50, 55, . . ., 105, 109,
Minimum PAV (ms) 30, 40, . . .,
Minimum SAV (ms) 30, 40, . . .,
1-18
GEM®III DR System Reference Guide
Off
115, 120, 125, 130, 136, 140, 146,
150, 154, 158, 167, 171, 176, 182
115,
120
150, 154, 158, 167, 171, 176, 182
150, 160, . . ., 350
120, 130, . . ., 350
, 125, 130, 136, 140, 146,
140
,
110
,
Off Off
60 60
120 120
140 140
110 110
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