Connector
type
Delivered
Energy
(approx.)
DF-1
30 J
Name
Model
Number
Current Accel VR
CD1215-30
Single-chamber
ICD with RF
telemetry
Fortify™ DR
CD2233-40
Dual-chamber ICD DF-1/IS-1
with RF telemetry
40 J
Fortify DR
CD2233-40Q
Dual-chamber ICD DF4-LLHH/IS-1
with RF telemetry
40 J
Fortify ST DR
CD2235-40
Dual-chamber ICD DF-1/IS-1
with RF telemetry
40 J
Fortify ST DR
CD2235-40Q
Dual-chamber ICD DF4-LLHH/IS-1
with RF telemetry
40 J
Fortify ST VR
CD1235-40
Single-chamber
ICD with RF
telemetry
DF-1/IS-1
40 J
Fortify ST VR
CD1235-40Q
Single-chamber
ICD with RF
telemetry
DF4-LLHH
40 J
Fortify VR
CD1233-40
Single-chamber
ICD with RF
telemetry
DF-1/IS-1
40 J
Fortify VR
CD1233-40Q
Single-chamber
ICD with RF
telemetry
DF4-LLHH
40 J
Promote +
CD3211-36
CRT-D with
RF telemetry
DF-1/IS-1
36 J
Promote +
CD3211-36Q
CRT-D with
RF telemetry
DF4-LLHH/IS-1
36 J
Promote
3107-36
CRT-D
DF-1/IS-1
36 J
Promote
3107-36Q
CRT-D
DF4-LLHH/IS-1
36 J
Promote
3107-30
CRT-D
DF-1/IS-1
30 J
Promote
3109-36
CRT-D with LVonly pacing
DF-1/IS-1
36 J
Promote
3109-30
CRT-D with LVonly pacing
DF-1/IS-1
30 J
Promote
CD3207-36Q
CRT-D with RF
telemetry
DF4-LLHH/IS-1
36 J
Promote RF
3207-36
CRT-D with RF
telemetry
DF-1/IS-1
36 J
Description
Table 1. Pulse generator descriptions (continued)
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1-3
Connector
type
Delivered
Energy
(approx.)
Name
Model
Number
Promote RF
3207-30
CRT-D with RF
telemetry
DF-1/IS-1
30 J
Promote RF
3213-36
CRT-D with LVonly pacing and
RF telemetry
DF-1/IS-1
36 J
Promote RF
3213-30
CRT-D with LVonly pacing and
RF telemetry
DF-1/IS-1
30 J
Promote Accel
CD3215-36
CRT-D with
RF telemetry
DF-1/IS-1
36 J
Promote Accel
CD3215-36Q
CRT-D with
RF telemetry
DF4-LLHH/IS-1
36 J
Promote Accel
CD3215-30
CRT-D with LVonly pacing and
RF telemetry
DF-1/IS-1
30 J
Promote Q
CD3221-36
CRT-D
DF-1/SJ4-LLLL/
IS-1
36 J
Promote Q
CD3227-36
CRT-D
DF-1/SJ4-LLLL/
IS-1
36 J
Promote Quadra
CD3237-40
CRT-D with
RF telemetry
DF-1/DF4-LLHH 40 J
Promote Quadra
CD3237-40Q
CRT-D with
RF telemetry
DF4-LLHH/
SJ4-LLLL/IS-1
Promote Quadra
CD3239-40
CRT-D with
RF telemetry
DF-1/DF4-LLHH 40 J
Promote Quadra
CD3239-40Q
CRT-D with
RF telemetry
DF4-LLHH/
SJ4-LLLL/IS-1
40 J
Unify™
CD3235-40
CRT-D with
RF telemetry
DF-1/IS-1
40 J
Unify
CD3235-40Q
CRT-D with
RF telemetry
DF4-LLHH/IS-1
40 J
Description
40 J
Table 1. Pulse generator descriptions (continued)
1. SJ4-LLHH is compatible with DF4-LLHH. SJ4 and DF4 connectors comply with
ISO27186:2010(E).
These devices can be programmed with the Merlin™ Patient Care System
equipped with Model 3330 version 10.2 (or greater) software. For information
on programming, refer to the programmer’s on-screen help.
4
Device Description
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Device Description
Indications
The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular
arrhythmias. Cardiac Resynchronization Therapy devices (CRT-Ds) are also
intended to resynchronize the right and left ventricles in patients with congestive heart failure.
Contraindications
Contraindications for use of the pulse generator system include ventricular
tachyarrhythmias resulting from transient or correctable factors such as drug
toxicity, electrolyte imbalance, or acute myocardial infarction.
Warnings
Implantation Procedure
• The physician should be familiar with all components of the system and the
material in this manual before beginning the procedure.
• Ensure that a separate standby external defibrillator is immediately available.
• Implant the pulse generator no deeper than 5 cm to ensure reliable data
transmission. For patient comfort, do not implant the pulse generator
within 1.25 cm of bone unless you cannot avoid it.
Device Replacement
• Replace the pulse generator within three months of reaching ERI. Replace
the pulse generator immediately upon reaching ERI if there is frequent high-voltage charging and/or one or more of the pacing outputs are programmed above 2.5 V. See Table 16 on page 34.
Battery Incineration
• Do not incinerate pulse generators as they contain sealed chemical power
cells and capacitors that may explode. Return explanted devices to St. Jude
Medical.
High-Voltage Can
• Ensure that tachyarrhythmia therapy is programmed Off before handling
the pulse generator to avoid any risk of accidental shock. Do not program
tachyarrhythmia therapies On until the pulse generator is inserted in the
pocket.
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1-5
• For effective defibrillation, perform all defibrillation testing with the can in
the pocket.
Magnetic Resonance Imaging (MRI)
• Avoid MRI devices because of the magnitude of the magnetic fields and
the strength of the radiofrequency (RF) fields they produce.
Precautions
Device Modification
• This device has been tested for compliance to FCC regulations. Changes or
modifications of any kind not expressly approved by St. Jude Medical Inc.
could void the user’s authority to operate this device.
Device Storage
• Store the pulse generator at temperatures between 10° and 45°C. Do not
subject it to temperatures below -20° or over 60°C.
• After cold storage, allow the device to reach room temperature before
charging the capacitors, programming, or implanting the device because
cold temperature may affect initial device function.
Lead Impedance
• Do not implant the pulse generator if the acute defibrillation lead impedance is less than 20 ¬ or the lead impedance of chronic leads is less than
15 ¬. Damage to the device may result if high-voltage therapy is delivered
into an impedance less than 15 ¬.
Device Communication
• Communication with the device can be affected by electrical interference
and strong magnetic fields. If this is a problem, turn off nearby electrical
equipment or move it away from the patient and the programmer. If the
problem persists, contact St. Jude Medical.
Suboptimal RF Communication
• The Merlin™ PCS indicates the quality of the RF communication by the
telemetry strength indicator LEDs on both the programmer and the Merlin
Antenna. Below is a list of potential causes to suboptimal radio communication:
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Device Description
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Device Description
Possible Causes
Solutions
The Merlin Antenna orientation/location is
suboptimal.
Move or reorient the Merlin Antenna
slightly. Make sure that the front of the
Merlin Antenna faces the implantable
device.
People or objects interfere with the
communication between the Merlin
Antenna and the device.
Make sure that the space between the
Merlin Antenna and the device is free from
interfering objects/people.
The Merlin Antenna is too far away from the Move the Merlin Antenna closer to the
device.
device.
Someone is holding the Merlin Antenna.
Place the Merlin Antenna on a flat surface.
Do not hold the Merlin Antenna.
Other products in the vicinity are causing
electromagnetic interference (EMI).
Power off or remove equipment that could
cause EMI.
The Merlin Antenna cable is wound around
the Merlin Antenna.
Make sure the Merlin Antenna cable is not
wound around the Merlin Antenna.
Table 2. Possible causes and solutions for suboptimal RF communication
Disconnecting Leads
• Connecting or disconnecting sense/pace leads can produce electrical artifacts that can be sensed by the pulse generator. To prevent detection of
artifacts, reprogram the pulse generator to tachyarrhythmia therapy Off:
- Before disconnecting the leads from a pulse generator in the operating
room
- Before a post-mortem examination
- Whenever there are no leads connected to it
- When sense/pace leads are connected but are not implanted in a
patient
If a programmer is not available, use a magnet to prevent delivery of tachyarrhythmia therapy in response to detected disconnection artifacts. Place
the magnet over the pulse generator before disconnecting the leads. Do
not remove it until the leads are reconnected.
CAUTION
The Magnet Response parameter must be set to
Normal for the magnet to prevent the delivery of
tachyarrhythmia therapy. For more information,
see ”Using a Magnet” on page 25.
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External Equipment for Arrhythmia Induction
• If external equipment is used for arrhythmia induction through the pulse
generator header and leads, apply rectified AC current through the highvoltage ports, not the sense/pace ports, to avoid damaging the sense/pace
function.
• Disconnect the external equipment from the pulse generator before any
therapy is delivered; otherwise, damage to the device is likely to occur.
Place a magnet over the device until the external equipment can be disconnected.
Antiarrhythmic Drugs
• Antiarrhythmic drugs may alter the defibrillation energy threshold, rendering the pulse generator’s countershock ineffective or causing the shock to
induce a clinically significant arrhythmia. In addition, changing cardiac electrical characteristics may prevent detection of a tachyarrhythmia or may
cause the pulse generator to misinterpret a normal rhythm as a clinically
significant arrhythmia. Changes in medication may require defibrillation
threshold testing, updating the morphology template, and reprogramming
of the device.
Sterilization
• The package contents have been sterilized with ethylene oxide before shipment. This device is for single use only and is not intended to be resterilized.
• If the sterile package has been compromised, contact St. Jude Medical.
Environmental Hazards
• External devices generating strong electromagnetic fields can cause operational problems in the pulse generator that include, but are not limited to:
cessation of or intermittent bradycardia pacing, and inadvertent antitachycardia pacing, cardioversion, or defibrillation. Additionally, high-energy
induced or conducted currents can reset the programmed parameters and
damage the pulse generator and tissue surrounding the implanted lead
electrodes.
Additional Pacemaker
• These devices provide bradycardia pacing. If another pacemaker is used, it
should have a bipolar pacing reset mode and be programmed for bipolar
pacing to minimize the possibility of the output pulses being detected by
the device.
8
Device Description
1-8
Device Description
External Defibrillators
• Shocks of sufficient strength can reset the programmed parameters or
damage the pulse generator and/or the tissue around the lead electrodes.
Whenever possible, disconnect the pulse generator from its leads before
applying defibrillator paddles.
• The effectiveness of external defibrillation may be reduced due to the
insulating effect of the implanted defibrillation electrodes. Minimize this
with proper external paddle placement relative to the orientation of the
implanted defibrillation electrodes. Deliver the energy perpendicular to a
line between the two implanted electrodes.
• As soon as possible after external/internal defibrillation, check the pulse
generator by verifying that:
- Programmed parameters remain as previously programmed
- Measurements (battery voltage, lead impedances, etc.) are appropriate
- Real-time EGM and status information indicate appropriate sensing of
cardiac signals
- Capture is maintained during bradycardia pacing
• Verify the proper functioning of the output circuitry by delivering a synchronous emergency shock.
• External defibrillation may reprogram the device to its reset values. Assess
any device parameter reset in conjunction with St. Jude Medical Technical
Service personnel.
Electrosurgical Instruments
• The pulse generator may detect electrocautery energy as cardiac events
and deliver tachyarrhythmia therapy. Electrocautery can also cause tissue
damage near the implanted electrodes, damage the pulse generator, or
reprogram the device to its reset values. Position the electrocautery ground
electrode to minimize current flow through the implanted electrode system. Do not apply electrocautery directly to the pulse generator.
• During electrosurgery, disable tachyarrhythmia therapy (Enable/Disable
Tachy Therapy) or program tachyarrhythmia therapy Off. If a programmer is
unavailable, use a magnet to inhibit delivery of tachyarrhythmia therapy.
Therapeutic Radiation
• Use devices emitting ionizing radiation with caution as they can damage
CMOS circuitry in the pulse generator. Devices such as linear accelerators,
betatrons and cobalt machines can be used with proper therapeutic planning to minimize cumulative dosage levels to the pulse generator. Diagnostic X-rays, although a source of ionizing radiation, generally produce much
lower levels and are not contraindicated. Consultation with clinical physicists and St. Jude Medical is recommended.
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Medical Lithotripsy
• Avoid lithotripsy unless the therapy site is not near the pulse generator and
leads as lithotripsy may damage the pulse generator.
Diathermy
• Avoid diathermy, even if the device is programmed off, as it may damage
tissue around the implanted electrodes or may permanently damage the
pulse generator.
Ultrasound Therapy
• Diagnostic and therapeutic ultrasound treatment is not known to affect
the function of the pulse generator.
Home and Industrial Environments
• A variety of devices produce electromagnetic interference (EMI) of sufficient field strength and modulation characteristics to interfere with proper
operation of the pulse generator. These include, but are not limited to:
high-powered radio, television, and radar transmitters/antennas; arc welders; induction furnaces; very large or defective electric motors; and internal
combustion engines with poorly shielded ignition systems.
• The patient should avoid strong magnetic fields since they are potentially
capable of inhibiting tachyarrhythmia therapies. If a patient is frequently in
a high-magnetic-field environment and therefore at risk of not having therapies delivered, you may choose to program the device to ignore magnetic
fields. Therapies would then be delivered in the normal manner in response
to detected arrhythmias. Magnet application would have no effect on
operation.
Electronic Article Surveillance (EAS)
Advise patients that the Electronic Article Surveillance/Anti-theft systems or
Electronic Article Surveillance (EAS) systems such as those at the point of sale
and entrances/exits of stores, libraries, banks, etc., emit signals that may interact with ICDs and CRT-Ds. It is very unlikely that these systems will interact with
their device significantly. However, to minimize the possibility of interaction,
advise patients to simply walk through these areas at a normal pace and avoid
lingering near or leaning on these systems.
Metal Detectors
Advise patients that metal detector security systems such as those found in airports and government buildings emit signals that may interact with ICDs and
CRT-Ds. It is very unlikely that these systems will interact with their device significantly. To minimize the possibility of interaction, advise patients to simply
10
Device Description
1-10
Device Description
walk through these areas at a normal pace and avoid lingering. Even so, the
ICD and CRT-D systems contain metal that may set off the airport security system alarm. If the alarm does sound, the patient should present security personnel with their patient identification card. If security personnel perform a search
with a handheld wand, they should ask the security personnel to perform the
search quickly, stressing that they should avoid holding the wand over the
device for a prolonged period.
Cellular Phones
The pulse generator has been tested for compatibility with handheld wireless
transmitters in accordance with the requirements of AAMI PC69. This testing
covered the operating frequencies (450 MHz - 3 GHz) and pulsed modulation
techniques of all of the digital cellular phone technologies in worldwide use
today. Based on the results of this testing, the pulse generator should not be
affected by the normal operation of cellular phones.
Adverse Events
Implantation of the pulse generator system, like that of any other device,
involves risks, some possibly life-threatening. These include but are not limited
to the following:
• Acute hemorrhage/bleeding
• Air emboli
• Arrhythmia acceleration
• Cardiac or venous perforation
• Cardiogenic shock
• Cyst formation
• Erosion
• Exacerbation of heart failure
• Extrusion
• Fibrotic tissue growth
• Fluid accumulation
• Hematoma formation
• Histotoxic reactions
• Infection
• Keloid formation
• Myocardial irritability
• Nerve damage
• Pneumothorax
• Thromboemboli
• Venous occlusion
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1-11
Other possible adverse effects include mortality due to:
• Component failure
• Device-programmer communication failure
• Lead abrasion
• Lead dislodgment or poor lead placement
• Lead fracture
• Inability to defibrillate
• Inhibited therapy for a ventricular tachycardia
• Interruption of function due to electrical or magnetic interference
• Shunting of energy from defibrillation paddles
• System failure due to ionizing radiation
Other possible adverse effects include mortality due to inappropriate delivery of
therapy caused by:
• Multiple counting of cardiac events including T-waves, P-waves, or supplemental pacemaker stimuli
Among the psychological effects of device implantation are imagined pulsing,
dependency, fear of inappropriate pulsing, and fear of losing pulse capability.
Persons administering cardiopulmonary resuscitation (CPR) have reportedly
been startled by voltage present on the patient’s body surface during discharge
of the pulse generator. The voltage decreases as the discharge disperses toward
the periphery of the body, and is weakest at the furthest extension of the limbs.
Nevertheless, there is a highly remote possibility that an arrhythmia may be
induced in someone administering CPR to the patient at the time a countershock is delivered.
12
Device Description
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Device Description
Promote Accel™ CRT-D
Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
with InvisiLink™ Wireless Telemetry
MODELS CD3215-30 and CD3215-36
Specifications
LV, RV, and Atrial Capture Confirmation features ensure capture of the
myocardium in response to pacing stimuli in the left ventricle, right ventricle and
right atrium. LVCap™, RVCap™ and ACap™ Confirm help ensure patient safety and
therapy delivery by automatically monitoring and adjusting capture thresholds
according to changing patient needs.
Designed to reduce unnecessary right ventricular pacing, the VIP™ algorithm
allows intrinsic conduction when possible and provides optimised ventricular
support when needed.
Advanced Biventricular Pacing options.
– Triggered Pacing with BiV Trigger Mode helps maintain a high percentage
of BiV pacing by triggering pacing in both the left and right ventricles in
response to a sensed ventricular event.
– VectSelect™ programmable LV pulse configuration (LV ring-RV coil, LV tip-RV
coil or LV bipolar) may be adjusted noninvasively via the programmer.
– Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present,
thereby promoting a high degree of ventricular pacing.
™
DeFT Response technology tools provide more clinically proven, non-invasive options for managing high DFTs.
– Programmable pulse widths allow the user to tailor the shock to the individual
patient, making shocks more efficacious.1
– SVC shocking electrode can be quickly and non-invasively activated or
deactivated with the press of a button.
– 36 J delivered energy (model CD3215-36) provides unsurpassed energy
for defibrillation.
– Four programmable tilt options are available to accommodate variances
among patients.2
– Together, these features may help to prevent additional surgeries.
Exclusive SenseAbility™ feature, with Decay Delay and Threshold Start, provides
the flexibility to fine-tune sensing to individual patient needs and help
eliminate oversensing of T waves, fractionated QRS complexes, and other
extraneous signals.
™
QuickOpt Timing Cycle Optimisation provides quick and effective optimisation
for more patients at the push of a button.3
– IEGM-based AV and V-V optimisation allows optimised timing without need
for echo-guided optimisation.
– V-V timing optimisation may help improve patient outcomes. Because not all
patients respond to simultaneous biventricular pacing, programmable timing
of right- and left-ventricular outputs helps to ensure appropriate therapy and
may reduce the number of non-responders.4
Exclusive Morphology Discrimination plus AV Rate Branch SVT discrimination
feature helps reduce the risk of inappropriate ICD shocks and is intended to
promote fast, accurate diagnosis and delivery of therapy. Clinical data states
that this combination resulted in a sensitivity of 100% with a specificity of
85%.5
Exclusive AF Suppression™ algorithm is clinically proven to suppress episodes
of paroxysmal and persistent AF.
– Studies show a 25% decrease in symptomatic AF burden.6
AT/AF Alerts notify patients and their clinics when a programmed AT/AF threshold
or continuous episode duration has been exceeded, or when a high ventricular rate
accompanies the AT/AF episode.
™
Exclusive DC Fibber induction has a documented 95,5% success rate for
inducing fibrillation on the first induction as compared with a 72,7% success rate
for Shock-on-T.7
Exercise Trend Diagnostic provides insight into the patient’s disease state
progression and exercise activity.
Up to 45 minutes of continuous, fully annotated stored electrograms, including
up to 60 seconds of pre-trigger information per electrogram.
– Preferential EGM storage capability allows prioritisation of episode storage.
Exclusive Vibratory Patient Notifier allows even patients with hearing problems
to be alerted to a low battery, lead-related complications and more.
Automatic Daily High-Voltage (HV) Lead Integrity Test is designed to
automatically test the HV lead on a daily basis to ensure therapy delivery
for optimal patient safety.
Multiple hardware and software system safeguards for added security
and patient comfort.
The capability to program multiple ATP schemes per zone has the potential to
increase the success of ATP prior to requiring a shock.
InvisiLink™ wireless telemetry, in conjunction with the Merlin@home™ transmitter and Merlin.net™ PCN, allows for seamless remote monitoring and follow-up. InvisiLink RF telemetry uses a dedicated range of frequencies designated for
medical devices called the MICS (Medical Implant Communications Service)
frequency band, which helps reduce the interference seen on frequencies used
by common household electronics.
Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated
treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronisation Therapy devices (CRT-Ds) are also intended to
resynchronise the right and left ventricles in patients with congestive heart failure.
Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from
transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
Warnings and Precautions:
Implantation Procedure. The physician should be familiar with all components of the system and the material in this manual before
beginning the procedure. Ensure that a separate standby external defibrillator is immediately available. Implant the pulse generator
no deeper than 5 cm to ensure reliable data transmission. For patient comfort, do not implant the pulse generator within 1,25 cm of
bone unless you cannot avoid it.
Device Replacement. Replace the pulse generator within three months of reaching the 2,45 V indication. Replace the pulse generator
immediately upon reaching 2,45 V if there is frequent high-voltage charging and/or one or more of the pacing outputs are programmed
above 2,5 V.
Battery Incineration. Do not incinerate pulse generators as they contain sealed chemical power cells and capacitors that may
explode. Return explanted devices to St. Jude Medical.
High-Voltage Can. Ensure that tachyarrhythmia therapy is programmed Off before handling the pulse generator to avoid any risk
of accidental shock. Do not program tachyarrhythmia therapies On until the pulse generator is inserted in the pocket. For effective
defibrillation, perform all defibrillation testing with the can in the pocket.
Magnetic Resonance Imaging (MRI). Avoid MRI devices because of the magnitude of the magnetic fields and the strength of the
radiofrequency (RF) fields they produce.
Device Storage. Store the pulse generator at temperatures between 10° and 45°C. Do not subject it to temperatures below -20° or
over 60°C. After cold storage, allow the device to reach room temperature before charging the capacitors, programming, or implanting
the device because cold temperature may affect initial device function.
Device Communication. Communication with the device can be affected by electrical interference and strong magnetic fields.
If this is a problem, turn off nearby electrical equipment or move it away from the patient and the programmer. If the problem
persists, contact St. Jude Medical.
Lead Impedance. Do not implant the pulse generator if the acute defibrillation lead impedance is less than 20 ohms or the lead
impedance of chronic leads is less than15 ohms. Damage to the device may result if high-voltage therapy is delivered into an
impedance less than 15 ohms.
Suboptimal RF Communication. The Merlin™ PCS indicates the quality of the RF communication by the telemetry strength indicator
LEDs on both the programmer and the Merlin Antenna.
Disconnecting Leads. Connecting or disconnecting sense/pace leads can produce electrical artifacts that can be sensed by the pulse
generator. To prevent detection of artifacts, reprogram the pulse generator to tachyarrhythmia therapy Off: Before disconnecting the
leads from a pulse generator in the operating room; Before a post-mortem examination; Whenever there are no leads connected to it;
When sense/pace leads are connected but are not implanted in a patient. If a programmer is not available, use a magnet to prevent
delivery of tachyarrhythmia therapy in response to detected disconnection artifacts. Place the magnet over the pulse generator before
disconnecting the leads. Do not remove it until the leads are reconnected.
External Equipment for Arrhythmia Induction. If external equipment is used for arrhythmia induction through the pulse generator
header and leads, apply rectified AC current through the high-voltage ports, not the sense/pace ports, to avoid damaging the sense/
pace function: disconnect the external equipment from the pulse generator before any therapy is delivered; otherwise, damage to the
device is likely to occur. Place a magnet over the device until the external equipment can be disconnected.
Adverse Events:
Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include
but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation,
cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation,
hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax,
thromboemboli, venous occlusion. Other possible adverse effects include mortality due to: component failure, device-programmer
communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited
therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from
defibrillation paddles, system failure due to ionising radiation. Other possible adverse effects include mortality due to inappropriate
delivery of therapy caused by: multiple counting of cardiac events including T-waves, P-waves, or supplemental pacemaker stimuli.
Among the psychological effects of device implantation are imagined pulsing, dependency, fear of inappropriate pulsing, and fear of
losing pulse capability.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Post-Therapy Pacing (Independently programmable from Bradycardia and ATP )
PHYSICAL SPECIFICATIONS
Models
Telemetry
Delivered Energy
Volume (cc)
Weight (g)
Size (mm)
Defibrillation Lead Connections
Sense/Pace Lead Connections
High Voltage Can CD3215-30
RF
30 J
39
76
80 x 50 x 13
DF-1
IS-1
Electrically active titanium can
CD3215-36
RF
36 J
43
82
81 x 50 x 14
DF-1
IS-1
Electrically active titanium can
Off, AAI, VVI, DDI, or DDD
30-100 in increments of 5
Off, 0,5; 1; 2,5; 5; 7,5; or 10
Device Testing/Induction Methods
DC Fibber™ Pulse Duration (sec)
Burst Fibber Cycle Length (ms)
Noninvasive Programmed
Stimulation (NIPS)
0,5-5,0
20-100
2-25 stimuli with up to three extrastimuli
Patient Notifiers
PARAMETER SETTINGS
V. Triggering (BiV Trigger Mode)
QuickOpt™ Timing Cycle Optimisation
V-V Timing
Interventricular Pace Delay (ms)
Ventricular Sensing
Ventricular Pacing Chamber
Negative AV Hysteresis/Search (ms)
Shortest AV Delay (ms)
VectSelect™ LV Pulse Configuration
Programmable Notifiers (On, Off)
Device Reset
Entry into Backup VVI Mode
Vibration Duration (sec)
Number of Vibrations per Notification
Number of Notifications
Time Between Notifications (hours)
On, Off
Sensed/paced AV delay, Interventricular Pace delay
Simultaneous*, RV First, LV First
RV First 10-80 / LV First 15-80 in increments of 5
RV only (not programmable)
RV only, biventricular
Off, -10 to -120
25-120
LV tip to RV coil, LV bipolar, LV ring to RV coil
AF Management
Device at ERI, Charge Time Limit Reached, Possible HV Circuit Damage,
Atrial Lead Impedance Out of Range, Ventricular Lead Impedance
Out of Range, AT/AF Burden
On
On
2, 4, 6, 8, 10, 12, 14, 16
2
1-16
10, 22
Electrograms and Diagnostics
AF Suppression™ Pacing
No. of Overdrive Pacing Cycles
Maximum AF Suppression Rate
On, Off
15-40 in steps of 5
80-150 min-1
Sensing/Detection
SenseAbility™ Technology
Threshold Start
Decay Delay
Ventricular Sense Refractory (ms)
Detection Zones
SVT Discriminators
Reconfirmation
Automatic Sensitivity Control adjustment for atrial and ventricular events
(Post-Sensed, Atrial) 50; 62,5; 75; 100%; (Post-Paced, Atrial) 0,2-3,0 mV;
(Post-Sensed, Ventricular) 50; 62,5; 75; 100%; (Post-Paced, Ventricular)
Auto, 0,2-3,0 mV
(Post-Sense/Post-Pace, Atrial/Ventricular) 0-220
125, 157
VT-1, VT-2, VF
AV Rate Branch, Sudden Onset, Interval Stability, Morphology
Discrimination (MD) with Manual or Automatic Template Update
Continuous sensing during charging
Antitachycardia Pacing Therapy
ATP Configurations
Burst Cycle Length
Min. Burst Cycle Length (ms)
Number of Bursts/Stimuli
Add Stimuli per Burst
Ramp, Burst, Scan; 1 or 2 schemes per zone
Adaptive, Readaptive or Fixed
150-400 in increments of 5
1-15 with 2-20 Stimuli
On, Off
High Voltage Output Mode
Waveform
RV Polarity
Electrode Configuration
Up to 45 minutes including up to one minute programmable pre-trigger
data per VT/VF diagnosis/detection electrograms; triggers include
diagnosis, therapy, atrial episode, PMT termination, PC shock delivery,
noise reversion, magnet reversion, and morphology template verification
Diagram of therapies delivered
Directory listing of up to 60 episodes with access to more details including
stored electrograms
History of bradycardia events and device-initiated charging
Trend data and counts
Multi-Vector Trend Data
Event Histogram, AV Interval Histogram, Mode Switch Duration Histogram,
Peak Filtered Rate Histogram, Atrial Heart Rate Histogram, Ventricular
Heart Rate Histogram, AT/AF Burden, Exercise and Activity Trending,
V Rates During AMS
Information regarding PMT detections
Pacing lead impedances, high voltage lead impedances, unloaded
battery voltage, and signal amplitudes
1 Mouchawar G, Kroll M, Val-Mejias JE et al. ICD waveform optimization: a randomized prospective,
pair-sampled multicenter study. PACE 2000; 23 (Part II):1992-1995.
2 Sweeney MO, Natale A, Volosin KJ et al. Prospective randomized comparison of 50%/50% versus 65%/65% tilt
biphasic waveform on defibrillation in humans. PACE 2001; 24:60-65.
Fixed Pulse Width, Fixed Tilt
Biphasic, Monophasic
Cathode (-), Anode (+)
RV to Can, RV to SVC/Can
3 Baker et al. Acute evaluation of programmer-guided AV/PV and VV delay optimization comparing an IEGM
method and echocardiogram for cardiac resynchronization therapy in heart failure patients and dual-chamber
ICD implants. Journal of Cardiovascular Electrophysiology, Vol. 18 No. 2, Feb. 2007.
4 Chan et al. Tissue Doppler guided optimization of A-V and V-V delay of biventricular pacemaker improves
response to cardiac resynchronization therapy in heart failure patients. J Cardiac Failure 2004; 10:4
(supplement): 572 (abstract 199).
Bradycardia Pacing
Permanent Modes
Off, DDD(R), DDT(R), DDI(R), VVT(R), VVI(R), AAI(R)
Temporary Modes
Off, DDD(R), DDT(R), DDI(R), VVT(R), VVI(R), AAI(R), AAT, DOO, VOO, AOO
Rate-Adaptive Sensor
On, Off, Passive
Programmable Rate and Off, Base Rate (min-1), Rest Rate (min-1), Maximum Tracking Rate (min-1)
Delay Parameters
Maximum Sensor Rate (min-1), Paced AV Delay (ms), Sensed AV Delay (ms),
Rate Responsive AV Delay, Pulse Amplitude (Atrial, RV and LV) (V),
Pulse Width (Atrial, RV and LV) (ms), Hysteresis Rate (min-1),
Rate Hysteresis with Search
Auto Mode Switch (AMS)
Off, DDI(R), DDT(R), VVI(R), VVT(R)
-1
AMS Detection Rate (min )
110-300
AMS Base Rate
40, 45, ...135
Auto PMT Detection/Termination
A Pace on PMT, Off, Passive
Rate Responsive PVARP/VREF
Off, Low, Medium, High
™
Ventricular Intrinsic Preference (VIP ) Off, 50-200 (50-150 in increments of 25; 160-200 in increments of 10)
™
™
LV Cap Confirm, RV Cap Confirm Setup, On, Monitor, Off
ACap™ Confirm
On, Monitor, Off
Cardiac Rhythm Management
Stored Electrograms
Therapy Summary
Episodes Summary
Lifetime Diagnostics
AT/AF Burden Trend
Ventricular HV Lead Impedance Trend
Histograms
PMT Data
Real-Time Measurements (RTM)
*LV first with 10 ms interventricular delay.
High Voltage Therapy
Atrial Fibrillation
Post-Shock Pacing Mode
Post-Shock Base Rate (min-1)
Post-Shock Pacing Duration (min)
Cardiac Surgery
Cardiology
Global Headquarters
One Lillehei Plaza
St. Paul, Minnesota 55117
USA
+1 651 483 2000
+1 651 490 4310 Fax
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, California 91342
USA
+1 818 362 6822
+1 818 364 5814 Fax
St. Jude Medical Sweden AB
Veddestavägen 19
175 84 Järfälla
Sweden
+46 8 474 4000
+46 8 760 3855 Fax
St. Jude Medical Brasil Ltda.
Rua Frei Caneca, 1380
7º ao 9º andares
01307-002 - São Paulo (SP)
Brazil
+55 11 5080 5400
+55 11 5080 5423 Fax
St. Jude Medical (Hong Kong) Ltd.
Unit 2701-07 27/F, COSCO Tower
Grand Millennium Plaza
183 Queen’s Road
Central, Hong Kong
+852 2996 7688
+852 2956 0622 Fax
St. Jude Medical Japan Co., Ltd.
3-1-30, Minami-Aoyama
Minato-ku
Tokyo 107 0062
Japan
+81 3 3423 6450
+81 3 3402 5586 Fax
5 Sperzel J, Meine M et al. A new automatic update function of the morphology template used for SVT/VT
discrimination in an ICD. Europace Supplements; Vol. 3, July 2002; A 131, #1515.
6 Summary of Safety and Effectiveness, P88086/S83 and P830015/S76; St. Jude Medical.
7 Sharma AD, O’Neill PG, Fain E et al. Shock on T versus DC for induction of ventricular fibrillation: a randomized
prospective comparison. 21st Annual Scientific Session North American Society of Pacing and Electrophysiology
(NASPE). Poster presentation published in meeting proceedings. Washington D.C., U.S.A. May 2000.
Neuromodulation
St. Jude Medical Europe, Inc.
The Corporate Village
Figueras Building
Avenue Da Vinci Iaan, 11 Box F1
B-1935 Zaventem
Belgium
+32 2 774 68 11
+32 2 772 83 84 Fax
sjm.com
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available
in all countries. Check with your St. Jude Medical representative for product availability in your country. Unless otherwise noted,
™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL,
the nine-squares symbol and MORE CONTROL. LESS RISK. are trademarks and service marks of St. Jude Medical, Inc.
and its related companies. ©2008 St. Jude Medical, Inc. All Rights Reserved.
Item No. GMCRM393
Promote Accel™
Cardiac Resynchronisation Therapy Defibrillator (CRT-D)
with SJ4 Connector
MODEL CD3215-36Q
Specifications
The SJ4 connector is designed to simplify implants by streamlining defibrillation
connections into a single terminal pin and reducing the number of set screws.
The SJ4 connection reduces pocket bulk, which may provide increased comfort,
particularly for patients who are thin or small in stature, and could lessen the risk
of lead-to-can abrasion, a known complication.
LV, RV, and Atrial Capture Confirmation features ensure capture of the
myocardium in response to pacing stimuli in the left ventricle, right ventricle
and right atrium. LVCap™, RVCap™ and ACap™ Confirm help ensure patient safety
and therapy delivery by automatically monitoring and adjusting capture
thresholds according to changing patient needs.
Advanced Biventricular Pacing options.
– Triggered Pacing with BiV Trigger Mode helps maintain a high percentage
of BiV pacing by triggering pacing in both the left and right ventricles in
response to a sensed ventricular event.
– VectSelect programmable LV pulse configuration (LV ring-RV coil, LV tip-RV
coil or LV bipolar) may be adjusted noninvasively via the programmer.
™
– Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present,
thereby promoting a high degree of ventricular pacing.
DeFT Response™ technology tools provide more clinically proven, non-invasive options for managing high DFTs.
– Programmable pulse widths allow the user to tailor the shock to the individual
patient, making shocks more efficacious.1
– SVC shocking electrode can be quickly and non-invasively activated or
deactivated with the press of a button.
– 36 J delivered energy provides unsurpassed energy for defibrillation.
– Four programmable tilt options are available to accommodate variances
among patients.2
– Together, these features may help to prevent additional surgeries.
Exclusive SenseAbility ™ feature, with Decay Delay and Threshold Start, provides
the flexibility to fine-tune sensing to individual patient needs and help
eliminate oversensing of T waves, fractionated QRS complexes, and other
extraneous signals.
QuickOpt™ Timing Cycle Optimisation provides quick and effective optimisation
for more patients at the push of a button.3
– IEGM-based AV and V-V optimisation allows optimised timing without need
for echo-guided optimisation.
– V-V timing optimisation may help improve patient outcomes. Because not all
patients respond to simultaneous biventricular pacing, programmable timing
of right- and left-ventricular outputs helps to ensure appropriate therapy and
may reduce the number of non-responders.4
Exclusive Morphology Discrimination plus AV Rate Branch SVT discrimination
feature helps reduce the risk of inappropriate ICD shocks and is intended to
promote fast, accurate diagnosis and delivery of therapy. Clinical data states
that this combination resulted in a sensitivity of 100% with a specificity of
85%.5
Exclusive AF Suppression™ algorithm is clinically proven to suppress episodes
of paroxysmal and persistent AF.
– Studies show a 25% decrease in symptomatic AF burden.6
AT/AF Alerts notify patients and their clinics when a programmed AT/AF threshold
or continuous episode duration has been exceeded, or when a high ventricular rate
accompanies the AT/AF episode.
Exclusive DC Fibber™ induction has a documented 95,5% success rate for inducing fibrillation on the first induction as compared with a 72,7% success
rate for Shock-on-T.7
Exercise Trend Diagnostic provides insight into the patient’s disease state
progression and exercise activity.
Up to 45 minutes of continuous, fully annotated stored electrograms, including
up to 60 seconds of pre-trigger information per electrogram.
– Preferential EGM storage capability allows prioritisation of episode storage.
Exclusive Vibratory Patient Notifier allows even patients with hearing problems
to be alerted to a low battery, lead-related complications and more.
Automatic Daily High-Voltage (HV) Lead Integrity Test is designed to
automatically test the HV lead on a daily basis to ensure therapy delivery
for optimal patient safety.
Multiple hardware and software system safeguards for added security
and patient comfort.
The capability to program multiple ATP schemes per zone has the potential to
increase the success of ATP prior to requiring a shock.
InvisiLink™ wireless telemetry, in conjunction with the Merlin@home™ transmitter and Merlin.net™ Patient Care Network (PCN), allows for seamless remote
monitoring and follow-up. InvisiLink RF telemetry uses a dedicated range of
frequencies designated for medical devices called the MICS (Medical Implant
Communications Service) frequency band, which helps reduce the interference
seen on frequencies used by common household electronics.
Indications: The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for
automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronisation Therapy devices (CRT-Ds)
are also intended to resynchronise the right and left ventricles in patients with congestive heart failure.
Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias
resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance,
or acute myocardial infarction.
Warnings and Precautions:
Implantation Procedure. The physician should be familiar with all components of the system and the material in this
manual before beginning the procedure. Ensure that a separate standby external defibrillator is immediately available.
Implant the pulse generator no deeper than 5 cm to ensure reliable data transmission. For patient comfort, do not implant
the pulse generator within 1,25 cm of bone unless you cannot avoid it.
Device Replacement. Replace the pulse generator within three months of reaching the 2,45 V indication. Replace the
pulse generator immediately upon reaching 2,45 V if there is frequent high-voltage charging
and/or one or more of the pacing outputs are programmed above 2,5 V.
Battery Incineration. Do not incinerate pulse generators as they contain sealed chemical power cells and capacitors that
may explode. Return explanted devices to St. Jude Medical.
High-Voltage Can. Ensure that tachyarrhythmia therapy is programmed Off before handling the pulse generator to avoid
any risk of accidental shock. Do not program tachyarrhythmia therapies On until the pulse generator is inserted in the
pocket. For effective defibrillation, perform all defibrillation testing with the can in the pocket.
Magnetic Resonance Imaging (MRI). Avoid MRI devices because of the magnitude of the magnetic fields and the
strength of the radiofrequency (RF) fields they produce.
Device Storage. Store the pulse generator at temperatures between 10° and 45°C. Do not subject it to temperatures
below -20° or over 60°C. After cold storage, allow the device to reach room temperature before charging the capacitors,
programming, or implanting the device because cold temperature may affect initial device function.
Device Communication. Communication with the device can be affected by electrical interference and strong magnetic
fields. If this is a problem, turn off nearby electrical equipment or move it away from the patient and the programmer. If
the problem persists, contact St. Jude Medical.
Lead Impedance. Do not implant the pulse generator if the acute defibrillation lead impedance is less than
20 ohms or the lead impedance of chronic leads is less than 15 ohms. Damage to the device may result if
high-voltage therapy is delivered into an impedance less than 15 ohms.
Suboptimal RF Communication. The Merlin™ PCS indicates the quality of the RF communication by the telemetry strength
indicator LEDs on both the programmer and the Merlin Antenna.
Disconnecting Leads. Connecting or disconnecting sense/pace leads can produce electrical artifacts that can be sensed
by the pulse generator. To prevent detection of artifacts, reprogram the pulse generator to tachyarrhythmia therapy
Off: Before disconnecting the leads from a pulse generator in the operating room; Before a post-mortem examination;
Whenever there are no leads connected to it; When sense/pace leads are connected but are not implanted in a patient.
If a programmer is not available, use a magnet to prevent delivery of tachyarrhythmia therapy in response to detected
disconnection artifacts. Place the magnet over the pulse generator before disconnecting the leads. Do not remove it until
the leads are reconnected.
External Equipment for Arrhythmia Induction. If external equipment is used for arrhythmia induction through the pulse
generator header and leads, apply rectified AC current through the high-voltage ports, not the sense/pace ports, to avoid
damaging the sense/pace function: disconnect the external equipment from the pulse generator before any therapy is
delivered; otherwise, damage to the device is likely to occur. Place a magnet over the device until the external equipment
can be disconnected.
Adverse Events:
Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening.
These include but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac
or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue
growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability,
nerve damage, pneumothorax, thromboemboli, venous occlusion. Other possible adverse effects include mortality due to:
component failure, device-programmer communication failure, lead abrasion, lead dislodgment or poor lead placement,
lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to
electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionising radiation.
Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by: multiple counting of
cardiac events including T waves, P waves, or supplemental pacemaker stimuli. Among the psychological effects of device
implantation are imagined pulsing, dependency, fear of inappropriate pulsing, and fear of losing pulse capability.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Post-Therapy Pacing (Independently programmable from Bradycardia and ATP )
PHYSICAL SPECIFICATIONS
Post-Shock Pacing Mode
Post-Shock Base Rate (min-1)
Post-Shock Pacing Duration (min)
Models
Telemetry
Delivered Energy (J)
Volume (cc)
Weight (g)
Size (mm)
Defibrillation Lead Connections
Sense/Pace Lead Connections
High Voltage Can PARAMETER
CD3215-36Q
RF
36
42
82
75 x 50 x 14
SJ4
IS-1; SJ4
Electrically active titanium can
V. Triggering (BiV Trigger Mode)
QuickOpt™ Timing Cycle Optimisation
V-V Timing
Interventricular Pace Delay (ms)
Ventricular Sensing
Ventricular Pacing Chamber
Negative AV Hysteresis/Search (ms)
Shortest AV Delay (ms)
VectSelect™ LV Pulse Configuration
On; Off
Sensed/paced AV delay; Interventricular Pace delay
Simultaneous*; RV First; LV First
RV First 10-80 / LV First 15-80 in increments of 5
RV only (not programmable)
RV only; biventricular
Off; -10 to -120
25-120
LV tip to RV coil; LV bipolar; LV ring to RV coil
Off; AAI; VVI; DDI; or DDD
30-100 in increments of 5
Off; 0,5; 1; 2,5; 5; 7,5; or 10
Device Testing/Induction Methods
DC Fibber™ Pulse Duration (sec)
Burst Fibber Cycle Length (ms)
Noninvasive Programmed
Stimulation (NIPS)
0,5-5,0
20-100
2-25 stimuli with up to three extrastimuli
Patient Notifiers
Settings
Programmable Notifiers (On, Off)
Device Parameter Reset
Entry into Backup VVI Mode
Vibration Duration (sec)
Number of Vibrations per Notification
Number of Notifications
Time Between Notifications (hours)
Device at ERI; Charge Time Limit Reached; Possible HV Circuit Damage;
Atrial Lead Impedance Out of Range; RV Lead Impedance Out of Range;
LV Lead Impedance Out of Range; High-Voltage Lead Impedance Out of Range; AT/AF Burden
On
On
2; 4; 6; 8; 10; 12; 14; 16
2
1-16
10; 22
AF Management
AF Suppression™ Pacing
No. of Overdrive Pacing Cycles
Maximum AF Suppression Rate
Electrograms and Diagnostics
On; Off
15-40 in steps of 5
80-150 min-1
Sensing/Detection
SenseAbility™ Technology
Threshold Start
Decay Delay
Ventricular Sense Refractory (ms)
Detection Zones
SVT Discriminators
Reconfirmation
Automatic Sensitivity Control adjustment for atrial and ventricular events
(Post-Sensed; Atrial) 50; 62,5; 75; 100%; (Post-Paced, Atrial) 0,2-3,0 mV;
(Post-Sensed; Ventricular) 50; 62,5; 75; 100%; (Post-Paced; Ventricular)
Auto; 0,2-3,0 mV
(Post-Sense/Post-Pace; Atrial/Ventricular) 0-220
125; 157
VT-1; VT-2; VF
AV Rate Branch; Sudden Onset; Interval Stability; Morphology
Discrimination (MD) with Manual or Automatic Template Update
Continuous sensing during charging
Antitachycardia Pacing Therapy
ATP Configurations
Burst Cycle Length
Min. Burst Cycle Length (ms)
Number of Bursts/Stimuli
Add Stimuli per Burst
Ramp; Burst; Scan; 1 or 2 schemes per zone
Adaptive; Readaptive or Fixed
150-400 in increments of 5
1-15 with 2-20 Stimuli
On; Off
1 Mouchawar G, Kroll M, Val-Mejias JE et al. ICD waveform optimization: a randomized prospective,
pair-sampled multicenter study. PACE 2000; 23 (Part II):1992-1995.
2 Sweeney MO, Natale A, Volosin KJ et al. Prospective randomized comparison of 50%/50% versus 65%/65% tilt
biphasic waveform on defibrillation in humans. PACE 2001; 24:60-65.
Fixed Pulse Width; Fixed Tilt
Biphasic; Monophasic
Cathode (-); Anode (+)
RV to Can; RV to SVC/Can
3 Baker et al. Acute evaluation of programmer-guided AV/PV and VV delay optimization comparing an IEGM
method and echocardiogram for cardiac resynchronization therapy in heart failure patients and dual-chamber
ICD implants. Journal of Cardiovascular Electrophysiology, Vol. 18 No. 2, Feb. 2007.
Bradycardia Pacing
Permanent Modes
Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R)
Temporary Modes
Off; DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); AAT; DOO; VOO; AOO
Rate-Adaptive Sensor
On; Off; Passive
Programmable Rate and Off; Base Rate (min-1); Rest Rate (min-1); Maximum Tracking Rate (min-1)
Delay Parameters
Maximum Sensor Rate (min-1); Paced AV Delay (ms); Sensed AV Delay (ms);
Rate Responsive AV Delay; Pulse Amplitude (Atrial; RV and LV) (V);
Pulse Width (Atrial; RV and LV) (ms); Hysteresis Rate (min-1);
Rate Hysteresis with Search
Auto Mode Switch (AMS)
Off; DDI(R); DDT(R); VVI(R); VVT(R)
-1
AMS Detection Rate (min )
110-300
Atrial Tachycardia Base Rate
40; 45; ...135
Auto PMT Detection/Termination
A Pace on PMT; Off; Passive
Rate Responsive PVARP/VREF
Off; Low; Medium; High
™
Ventricular Intrinsic Preference (VIP ) Off; 50-200 (50-150 in increments of 25; 160-200 in increments of 10)
™
™
LV Cap Confirm, RV Cap Confirm Setup; On; Monitor; Off
ACap™ Confirm
On; Monitor; Off
Atrial Fibrillation
Cardiac Rhythm Management
Up to 45 minutes including up to one minute programmable pre-trigger
data per VT/VF diagnosis/detection electrograms; triggers include
diagnosis; therapy; atrial episode; PMT termination; PC shock delivery;
noise reversion; magnet reversion; and morphology template verification
Diagram of therapies delivered
Directory listing of up to 60 episodes with access to more details including
stored electrograms
History of bradycardia events and device-initiated charging
Trend data and counts
Multi-Vector Trend Data
Event Histogram; AV Interval Histogram; Mode Switch Duration Histogram;
Peak Filtered Rate Histogram; Atrial Heart Rate Histogram; Ventricular
Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending;
V Rates During AMS
Information regarding PMT detections
Pacing lead impedances; high voltage lead impedances; unloaded
battery voltage; and signal amplitudes
*LV first with 10 ms interventricular delay.
High-Voltage Therapy
High-Voltage Output Mode
Waveform
RV Polarity
Electrode Configuration
Stored Electrograms
Therapy Summary
Episodes Summary
Lifetime Diagnostics
AT/AF Burden Trend
Ventricular HV Lead Impedance Trend
Histograms
PMT Data
Real-Time Measurements (RTM)
Cardiac Surgery
Cardiology
Global Headquarters
One Lillehei Plaza
St. Paul, Minnesota 55117
USA
+1 651 483 2000
+1 651 490 4310 Fax
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, California 91342
USA
+1 818 362 6822
+1 818 364 5814 Fax
St. Jude Medical Sweden AB
Veddestavägen 19
175 84 Järfälla
Sweden
+46 8 474 40 00
+46 8 760 95 42 Fax
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
+32 2 772 83 84 Fax
St. Jude Medical Brasil Ltda.
Rua Frei Caneca, 1380
7º ao 9º andares
01307-002 - São Paulo (SP)
Brazil
+55 11 5080 5400
+55 11 5080 5423 Fax
St. Jude Medical (Hong Kong) Ltd.
Unit 2701-07 27/F, COSCO Tower
Grand Millennium Plaza
183 Queen’s Road
Central, Hong Kong
+852 2996 7688
+852 2956 0622 Fax
4 Chan et al. Tissue Doppler guided optimization of A-V and V-V delay of biventricular pacemaker improves
response to cardiac resynchronization therapy in heart failure patients. J Cardiac Failure 2004; 10:4
(supplement): 572 (abstract 199).
5 Sperzel J, Meine M et al. A new automatic update function of the morphology template used for SVT/VT
discrimination in an ICD. Europace Supplements; Vol. 3, July 2002; A 131, #1515.
6 Carlson MD et al. A new pacemaker algorithm for the treatment of atrial fibrillation: results of the Atrial
Dynamic Overdrive Pacing Trial (ADOPT). JACC 2003; 42:627-633.
7 Sharma AD, O’Neill PG, Fain E et al. Shock on T versus DC for induction of ventricular fibrillation: a randomized
prospective comparison. 21st Annual Scientific Session North American Society of Pacing and Electrophysiology
(NASPE). Poster presentation published in meeting proceedings. Washington D.C., U.S.A. May 2000.
Neuromodulation
St. Jude Medical Japan Co., Ltd.
3-1-30, Minami-Aoyama
Minato-ku
Tokyo 107 0062
Japan
+81 3 3423 6450
+81 3 3402 5586 Fax
sjm.com
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings,
precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your St. Jude Medical
representative for product availability in your country. Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude
Medical or one of its subsidiaries. ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are trademarks and service
marks of St. Jude Medical, Inc. and its related companies. ©2009 St. Jude Medical, Inc. All Rights Reserved.
Item No. GMCRM453