St Jude Medical SJMRFB RF implantable medical device User Manual
St. Jude Medical RF implantable medical device
Users Manual
XXXX XXXX XXXX Reference Manual 1-1
Accent™
SR Model PM1110
SR RF Model PM1210
DR Model PM2110
DR RF Model PM2210
Pulse Generators
Anthem™
Model PM3110
RF Model PM3210
Cardiac Resynchronization Therapy Device,
Pulse Generator
User’s Manual
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1-2
CAUTION
Federal (USA) law restricts this device to sale by or
on the order of a physician.
Proposition 65, a State of California voter initiative, requires the fol-
lowing notice: WARNING: This product and its packaging have been
sterilized with ethylene oxide. This packaging may expose you to ethyl-
ene oxide, a chemical known to the state of California to cause cancer
or birth defects or other reproductive harm.
© 2009 St. Jude Medical Cardiac Rhythm Management Division.
All Rights Reserved.
Unless otherwise noted, ® or ™ indicates that the name is a trademark of,
or licensed to, St. Jude Medical, Inc. or its subsidiaries.
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XXXX XXXX XXXX Reference Manual 1-1
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 1
Device Description
This manual describes the following St. Jude Medical™ devices:
The pulse generator, along with compatible, commercially available leads, con-
stitutes the implantable portion of the pulse generator and CRT-P systems. The
lead systems are implanted using either transvenous or transthoracic tech-
niques. These devices can be programmed with Merlin Patient Care System
equipped with Model 3330 version 7.1 (or greater) software. For information
on programming, refer to the programmer’s on-screen help.
Indications and Usage
Implantation of Anthem™ and Anthem RF devices is indicated for:
• Maintaining synchrony of the left and right ventricles in patients who have
undergone an AV nodal ablation for chronic atrial fibrillation and have
NYHA Class II or III heart failure.
• The reduction of the symptoms of moderate to severe heart failure (NYHA
Class III or IV) in those patients who remain symptomatic despite stable,
optimal medical therapy, and have a left ventricular ejection fraction ≤
35% and a prolonged QRS duration.
Implantation of Accent™, Accent RF, Anthem, and Anthem RF devices is indi-
cated in one or more of the following permanent conditions:
• Syncope
• Presyncope
•Fatigue
• Disorientation
Name Model
Number Description
Accent SR PM1110 Single-chamber pulse generator
Accent SR RF PM1210 Single-chamber pulse generator with RF telemetry
Accent™ DR PM2110 Dual-chamber pulse generator
Accent DR RF PM2210 Dual-chamber pulse generator with RF telemetry
Anthem™ PM3110 CRT-P pulse generator
Anthem RF PM3210 CRT-P pulse generator with RF telemetry
Table 1. Accent and Anthem device descriptions
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1-2 Contraindications
2 Contraindications
• Or any combination of those symptoms.
Rate-Modulated Pacing is indicated for patients with chronotropic incompe-
tence,1 and for those who would benefit from increased stimulation rates con-
current with physical activity.
Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210,
Anthem, and Anthem RF devices only) is indicated for those patients exhibiting:
• Sick sinus syndrome
• Chronic, symptomatic second- and third-degree AV block
• Recurrent Adams-Stokes syndrome
• Symptomatic bilateral bundle branch block when tachyarrhythmia and
other causes have been ruled out.
Atrial Pacing is indicated for patients with sinus node dysfunction and normal
AV and intraventricular conduction systems.
Ventricular Pacing is indicated for patients with significant bradycardia and:
• Normal sinus rhythm with only rare episodes of A-V block or sinus arrest
• Chronic atrial fibrillation
• Severe physical disability.
AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem
and Anthem RF devices only) is indicated for suppression of paroxysmal or per-
sistent atrial fibrillation episodes in patients with one or more of the above pac-
ing indications.
For specific indications associated with individual modes, refer to the program-
mer’s on-screen help.
Contraindications
Implanted Cardioverter-Defibrillator (ICD). Accent™, Accent RF,
Anthem™, Anthem RF devices are contraindicated in patients with an
implanted cardioverter-defibrillator.
Rate-Adaptive Pacing may be inappropriate for patients who experience
angina or other symptoms of myocardial dysfunction at higher sensor-driven
rates. An appropriate Maximum Sensor Rate should be selected based on
assessment of the highest stimulation rate tolerated by the patient.
1. Chronotropic incompetence has not been rigorously defined. A conservative approach,
supported by the literature, defines chronotropic incompetence as the failure to achieve
an intrinsic heart rate of 70% of the age-predicted maximum heart rate or 120 min-1
during exercise testing, whichever is less, where the age-predicted heart rate is
calculated as 197 — (0.56 x age). Gwinn N, Leman R, Kratz J, et al. Chronotropic
incompetence: A common and progressive finding in pacemaker patients. American
Heart Journal 1992; 123:1216-19.
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Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 3
AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem,
Anthem RF devices only) stimulation is not recommended in patients who can-
not tolerate high atrial-rate stimulation.
Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210,
Anthem, Anthem RF devices only), though not contraindicated for patients
with chronic atrial flutter, chronic atrial fibrillation, or silent atria, may provide
no benefit beyond that of single-chamber pacing in such patients.
Single-Chamber Ventricular Demand Pacing is relatively contraindicated in
patients who have demonstrated pacemaker syndrome, have retrograde VA
conduction, or suffer a drop in arterial blood pressure with the onset of ventric-
ular pacing.
Single-Chamber Atrial Pacing is relatively contraindicated in patients who
have demonstrated compromise of AV conduction.
For specific contraindications associated with individual modes, refer to the pro-
grammer’s on-screen help.
Warnings and Precautions
To prevent permanent damage to the device and tissue damage at the elec-
trode/tissue interface:
• Electrosurgery. Do not use electrosurgical devices in the vicinity of an
implanted device. If electrocautery is necessary, use a bipolar cauterizer or
place the indifferent electrode as far from the device as possible.
• Lithotripsy. Do not focus a lithotripsy beam within 6 inches of the device.
Program the device to Sensor Off prior to lithotripsy to prevent inappropri-
ate increases in pacing rate. A thorough assessment of device function
with special attention to the sensor should be performed following expo-
sure to lithotripsy.
• Therapeutic Radiation. Do not use ionizing radiation in the vicinity of an
implanted device. Radiation therapy may damage the electronic circuitry of
the device.
• Ultrasound Treatment. Do not use therapeutic ultrasound within 6 inches
of the device.
• Ventricular Sensing. In Anthem™ and Anthem RF devices, Ventricular Sen-
sitivity should be programmed to the highest setting (lowest sensitivity)
that will provide ventricular sensing with adequate sensing margin. Left
ventricular lead dislodgement, to a position near the atria, can result in
atrial oversensing and ventricular inhibition.
Perform a thorough assessment of device function following exposure to any of
the above.
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1-4 Warnings and Precautions
4 Warnings and Precautions
Backup VVI Operation. In rare instances, the device may revert to Backup VVI
operation at the programmed settings listed in Table 2. These values are not
programmable.
When the device has reverted to Backup VVI operation, the programmer dis-
plays a pop-up message indicating that the device is operating at the Backup
VVI values. Press [Continue] and follow the on-screen instructions.
Elective Replacement Indicator (ERI). At ERI, the nominal life of the device is
three months. When the device exhibits signs of ERI, described on page 18, it
should be replaced expeditiously.
Patient follow-up visits should be scheduled at an appropriate frequency so
that ERI can be detected well before End-of-Life (EOL).
Noninvasive Programmed Stimulation (NIPS). Life-threatening ventricular
tachycardia or fibrillation may occur during NIPS, therefore: (1) closely monitor
the patient, and (2) make defibrillation and resuscitation equipment, and
trained personnel, readily available during testing. Only physicians trained in
tachycardia induction and reversion protocols should use NIPS. For more infor-
mation on NIPS, refer to the programmer’s on-screen help.
Ventricular Support Pacing during NIPS testing (Accent Model PM2110,
Accent RF Model PM2210, Anthem, and Anthem RF devices only) is delivered
Parameter Value
Accent™ Anthem™
Mode VVI VVI
Base Rate 67.5 ppm 67.5 ppm
Ventricular Pacing Chamber NA LV —> RV
Pulse Configuration Unipolar RV Unipolar Tip
LV Unipolar Tip
Sense Configuration Unipolar Tip RV Unipolar Tip
Pulse Amplitude 5.0 V 5.0 V
Pulse Width 0.6 ms 0.6 ms
Refractory Period 337 ms 337 ms
Sensitivity 2.0 mV 2.0 mV
Interventricular Delay NA 16 ms
Table 2. Backup VVI Settings
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XXXX XXXX XXXX Reference Manual 1-5
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 5
in the VOO mode. The specific indications and contraindications for VOO mode
can be found on the programmer’s on-screen help.
Precautions
For single use only.
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 pro-
grammer. If the problem persists, contact St. Jude Medical.
Suboptimal RF Communication.2 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 sub-
optimal radio communication:
CT Scans. CT scans, due to their increased power levels and long exposure
times, have the remote possibility of interfering with implanted devices. The
potential interference is transient and occurs only when the X-ray signal is
present. Continuous exposure may cause a temporary sensor rate increase. In
2. Available in Accent RF and Anthem RF devices only.
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 device. Move the Merlin Antenna closer to the
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 3. Possible causes and solutions for suboptimal RF communication
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1-6 Sterilization, Storage and Handling
6 Sterilization, Storage and Handling
addition, there is a remote possibility for a device to intermittently oversense
while the CT scanning beam is directly over the implanted device.
Sterilization, Storage and Handling
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 res-
terilized.
If the sterile package has been compromised, contact St. Jude Medical.
Mechanical Shock. St. Jude Medical® devices are ruggedly constructed. How-
ever, if you suspect the device has been damaged, do not implant it; return it to
St. Jude Medical.
Temperature. Do not subject the pulse generator to temperatures above 50ºC
(122ºF) or below –5ºC (23ºF). Exposure to temperatures below 0ºC may cause
false ERI indications. Following exposure to extreme temperatures, warm the
device to room temperature. If ERI indications are still present, return the pulse
generator to St. Jude Medical.
Incineration. Do not incinerate the device.
Preparation for Implantation
Package Label. Before opening the sterile package, carefully read the label
and verify that the package contains the desired device.
Verifying Operation. Before opening the sterile package, verify that the
device is operating properly by interrogating it in the package. Remove the
magnet and establish communication:
• Inductive communication. Position the Merlin® PCS telemetry wand over
the package and select “Interrogate.”
• RF communication. To establish RF communication between the device
and the programmer and to troubleshoot communications problems, you
must first attach the RF Antenna to the programmer. Please refer to the
Merlin™ Patient Care System User’s Manual that accompanies the pro-
grammer and the Merlin Antenna. Use the telemetry strength indicators to
evaluate the communication.
If the device is RF-compatible, an icon in the upper left-hand corner of the
screen during the programming session indicates the status of the RF com-
munication link. If an RF icon does not appear on the screen during the
session, the device is not RF-compatible. Once you have established tele-
metery, select “Interrogate.”
If The unit’s Measured Data will be displayed on the FastPath® Summary screen
and should indicate normal voltage and battery status, and the programmed
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XXXX XXXX XXXX Reference Manual 1-7
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 7
parameters should be identical to the Shipped Settings displayed on the pro-
grammer’s on-screen help.
Package Integrity. Ensure that the package has not been opened or in any
way compromised. If damage is suspected, return it to the manufacturer.
“Use Before” Date. Do not implant the device after the “use before” date
printed on the label.
Opening the Package. If interrogation of the device in its sterile packaging
indicates normal functioning, remove it from the package. The package’s outer
tray can be opened in nonsterile surroundings. However, when opening the
inner tray, complete sterile technique must be observed.
Pre-Implant Testing
Compatible Pacing Leads. These devices accept unipolar or bipolar IS-1 short
terminal pin leads. Use only St. Jude Medical® leads as the left ventricular lead
in Anthem™ and Anthem RF devices. Prior to implantation, make sure leads fit
easily and snugly into the device header.
Pacing System Analyzer. Before implantation, you may wish to test the
device using a compatible pacing system analyzer (PSA) with calibrated sensitiv-
ity and output settings. When the probe is attached to the device’s connector,
the programmed parameters should be identical to the Shipped Settings dis-
played on the programmer’s on-screen help.
Adaptor Probes. Use only IS-1 PSA cable adaptor probes when testing the
device. Other probes may damage the connector.
Capture/Sensing Thresholds. Capture and sensing thresholds should be
determined with a PSA before implanting the device. Connect the negative
(black) PSA terminal to the portion of the lead terminal pin corresponding to
the tip electrode. The positive (red) terminal should be connected to the ring
electrode portion of the lead pin for bipolar leads or to an indifferent electrode.
For more information on conducting capture and sensing threshold tests,
please consult the PSA technical manual.
Establishing Baseline Ventricular Capture/Sensing Thresholds (Anthem,
Anthem RF devices). After the leads have been implanted and before they are
connected to the device, separately identify and document the baseline mor-
phology for capture and sensing thresholds for each ventricular lead. Once
baselines are established, determine if the ECG or IEGM recordings can help
discriminate biventricular capture, and negative depolarizations for each lead.
In a cardiac resynchronization therapy system, the ECG may display two distinct
capture loss morphologies, because the left and right chambers often have dif-
ferent pacing thresholds. To ensure that the device is losing capture on both
sides of the heart, allow the test to run until a marked change in morphology
occurs, indicating capture loss on both sides.
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1-8 Implantation
8Implantation
Implantation
Ventricular Leads with Polished Platinum Tip Electrodes (Anthem™ and
Anthem RF devices only). Pairing a ventricular lead with a polished platinum tip
electrode with a ventricular lead with a tip electrode of a different material may
create a source impedance mismatch that could adversely affect sensing.
Data Transmission. 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.
Case Markings. Examine the markings on the device case and verify proper
atrial and ventricular connection.
Setscrew. Exercise caution when turning the setscrew, which may be backed
out of the connector if turned counter-clockwise for more than two rotations.
Programming
Programmer. These devices can be interrogated and programmed with the
Merlin® Patient Care System equipped with Model 3330 version 7.1 (or
greater) software.
For a list of programmable parameters and their programmable values, refer to
the programmer’s on-screen help.
Setting Lead Type. When you interrogate the device for the first time, the
programmer will prompt you to set the Lead Type. (In Anthem™ and Anthem
RF devices, the right and left ventricular lead types are independently set.)
Because some parameters are determined by the Lead Type (for example, Pulse
Configuration), you should set this parameter when the device is implanted.
Lead Impedance Values. In Anthem and Anthem RF devices, independent
lead impedance values are displayed for the RV and LV leads.
Ventricular Pulse Amplitudes and Pulse Widths. In Anthem and Anthem RF
devices, the right and left ventricular pulse amplitudes and pulse widths are
independently programmable. The pulse amplitude should be evaluated in
each chamber accordingly. Typically, capture thresholds are higher in the left
ventricle.
Follow-up Capture Threshold Measurements. In Anthem and Anthem RF
devices, the RV and LV capture threshold measurements are evaluated inde-
pendently. During an RV or LV capture test, you may be able to determine
when capture is occurring by noting changes in the ECG morphology. For addi-
tional information, refer to the programmer’s on-screen help.
AOO(R), VOO(R), and DOO(R) Modes are primarily intended for temporary
diagnostic use. Long-term use may result in competitive pacing, inducing
potentially dangerous arrhythmias.
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XXXX XXXX XXXX Reference Manual 1-9
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 9
Off mode is not recommended for patients who would be adversely affected
by even a short cessation of device function.
Pulse Amplitude. If the AutoCapture™ Pacing System or Cap Confirm are not
in use, determine the capture threshold before programming the Pulse Ampli-
tude. Program Pulse Amplitude to yield a suitable safety margin for reliable,
long-term capture. Reassess capture thresholds periodically.
Noninvasive Program Stimulation (NIPS). Atrial or ventricular tachycardia or
fibrillation may occur during NIPS. Therefore, (1) closely monitor the patient,
and (2) have emergency equipment for cardioversion/defibrillation readily avail-
able while conducting NIPS.
High-Output Settings. Programming high-output settings or a high Base Rate
may shorten the time to ERI.
Runaway Protection. Hardware circuitry in the device prevents it from stimu-
lating at rates higher than 210 min-1 (± 10 min-1).
Sensing Configuration. Sensing tests should be performed whenever
changes are made to the sensing configuration.
Sensitivity Settings. Careful consideration should be given to patient expo-
sure to electromagnetic interference if programming sensitivity greater than
0.5 mV with a bipolar sense configuration setting and 2.0 mV with a unipolar
sense configuration setting.
Environmental and Medical Therapy
Hazards
St. Jude Medical™ devices are equipped with special shielding and filters which
significantly reduce the adverse effects of electromagnetic interference (EMI)
on the operation of the device.
Patients should be directed to exercise reasonable caution in avoidance of
strong electric or magnetic fields. If the device inhibits or reverts to asynchro-
nous operation while in the presence of electromagnetic interference (EMI), the
patient should move away from the EMI source or turn the source off.
Advise patients to seek medical guidance before entering environments which
could adversely affect the operation of the device, including areas protected by
a warning notice preventing entry by pacemaker patients.
Medical Procedures and Environments
In general, pacemaker patients should not be exposed to hospital equipment
that produces high electromagnetic field strength signals, such as diathermy
machines and electrosurgical units.
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1-10 Environmental and Medical Therapy Hazards
10 Environmental and Medical Therapy Hazards
• External Defibrillation. The electronic circuitry in the device provides protec-
tion from defibrillation discharges. Nevertheless, do not place defibrillator
paddles directly over the device or pacing lead. Following defibrillation,
ensure that the device is operating correctly.
• Magnetic Resonance Imaging (MRI). MRI for patients with implantable
devices has been contraindicated by MRI manufacturers. Clinicians should
carefully weigh the decisions to use MRI with pacemaker patients. Addi-
tional safety concerns include:
- Magnetic and RF fields produced by MRI may increase pacing rate, inhibit
pacing, cause asynchronous pacing or result in pacing at random rates
- MRI may result in changes in capture thresholds due to heating of pacing
leads
- MRI may irreversibly damage the device
- Patients should be closely monitored during the MRI
- Assess the device function before and after exposure to MRI.
• Ionizing Radiation. Therapeutic ionizing radiation (for example, used in lin-
ear accelerators and cobalt machines) can permanently damage the
device’s circuitry. The effect of ionizing radiation is cumulative; the poten-
tial for damage to the device is proportional to the patient’s total radiation
dosage. If the patient must be exposed to ionizing radiation, protect the
device during the procedure with local radiation shielding. If tissue near the
implant site must be irradiated, it may be necessary to move the device to
another area. Before and after exposure to radiation, evaluate the device
operation to identify any adverse consequences.
• Transcutaneous Electrical Nerve Stimulation (TENS). To reduce the possibil-
ity of interference with device function, place the TENS electrodes close to
one another and as far from the device as possible. Before allowing unre-
stricted use of TENS in a home or other setting, screen the patient in a
monitored environment for possible interaction.
• Therapeutic Diathermy. Avoid diathermy, even if the device is programmed
off, as it may damage tissue around the implanted electrodes or may per-
manently damage the device.
• Electrosurgical Cautery can induce ventricular arrhythmias and/or fibrilla-
tion or may cause asynchronous or inhibited device operation. If use of
electrocautery is necessary, the current path and ground plate should be
kept as far away from the device and leads as possible. A bipolar cauterizer
may minimize these effects. Following electrocautery, conduct a thorough
assessment of the device.
• RF Ablation. Radiofrequency (RF) ablation in patients with a device may
cause any of the following: asychronous pacing above or below the pro-
grammed rate; reversion to an asynchronous operation; device electrical
reset; or premature triggering of the elective replacement indicator.
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XXXX XXXX XXXX Reference Manual 1-11
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 11
RF ablation risks may be minimized by: programming a non-rate responsive,
asynchronous pacing mode prior to the RF ablation procedure; avoid direct
contact between the ablation catheter and the implanted lead or device; posi-
tioning the ground plate so that the current pathway does not pass through or
near the device system, i.e., place the ground plate under the patient’s but-
tocks or legs; having a programmer available; or having external defibrillation
equipment available.
Patient Environment
High-Voltage transmission lines and equipment, arc or resistance weld-
ers, induction furnaces, and similar equipment may generate substantial EMI
fields that may interfere with device operation.
Communication Equipment, such as microwave transmitters,3 linear power
amplifiers, or high-power amateur transmitters may generate sufficient EMI to
interfere with the operation of the device. Advise patients to move away from
this equipment to resume normal device operation.
Home Appliances that are in good working order and properly grounded do
not usually produce enough EMI to interfere with device operation. Electric
vibrators, razors, and handtools held directly over the device may disturb its
operation.
Twiddler’s Syndrome. Caution patients against manipulating the implanted
device since it may result in lead damage or lead displacement.
Patient Activities. Any activities that involve repetitive impacts or jarring (such
as horseback riding, jackhammer use, etc.) may increase the pacing rate when
the device’s Sensor is programmed On. Caution patients against such activity
and program Sensor parameters with these activities in mind.
Electronic Article Surveillance (EAS). Advise patients that the Electronic Arti-
cle Surveillance/Anti-theft systems or Electronic Article Surveillance (EAS) sys-
tems such as those at the point of sale and entrances/exits of stores, libraries,
banks, etc., emit signals that may interact with pacemakers and CRT-Ps. It is
very unlikely that these systems will interact with their device significantly. How-
ever, 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.
No Pacer Symbol. Caution patients implanted with this device to avoid areas
marked with the NO PACER symbol.
3. Home appliance microwave ovens do not interfere with device operation.
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1-12 Explantation
12 Explantation
Figure 1. No Pacer Symbol
Cellular Phones. A St. Jude Medical-designed protective filter in Accent™,
Accent RF, Anthem™, and Anthem RF devices prevents cellular phone-gener-
ated electromagnetic signals from interfering with the operation of the device.4
The device has also been tested for compatibility with handheld wireless trans-
mitters in accordance with the requirements of AAMI PC69. This testing cov-
ered the operating frequencies (450 MHz - 3 GHz) and pulsed modulation
techniques of all of the digital cellular phone technologies in worldwide use
today. For more information, you or your patient may wish to contact Technical
Service (page 19).
Explantation
Do not reuse explanted devices and leads.
Clean explanted equipment with +1% sodium hypochlorite, rinse with
water, dry.
Return the explanted device to the manufacturer.
Explant the device before cremation of a deceased patient.
Hex wrenches are available for disconnecting a previously implanted device
from the indwelling leads. To obtain the wrenches, contact your local St. Jude
Medical representative.
Potential Adverse Events
The following are potential complications associated with the use of any pacing
system:
• Air embolism
• Body rejection phenomena
• Cardiac tamponade or perforation
4. Carrillo R, Williams DB, Traad EA, Schor JS. Electromagnetic filters impeded adverse
interference of pacemakers by digital cellular telephones. JACC 1996; 27(2A):15A
Abstract 901-22.
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XXXX XXXX XXXX Reference Manual 1-13
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 13
• Hematoma, bleeding hematoma, seroma
• Formation of fibrotic tissue, local tissue reaction
• Inability to interrogate or program due to programmer or device malfunc-
tion
• Infection/erosion
• Interruption of desired pulse generator function due to electrical interfer-
ence, either electromyogenic or electromagnetic
• Lead malfunction due to conductor fracture or insulation degradation
• Loss of capture or sensing due to lead dislodgement or reaction at the elec-
trode/tissue interface
• Loss of desired pacing and/or sensing due to lead displacement, body reac-
tion at electrode interface, or lead malfunction (fracture or damage to
insulation)
• Loss of normal device function due to battery failure or component mal-
function
• Pacemaker migration or pocket erosion
• Pectoral muscle or diaphragmatic stimulation
• Phrenic nerve stimulation
• Pneumothorax/hemothorax
• Device migration and pocket erosion
• Endocarditis
• Excessive bleeding
• Induced atrial or ventricular arrhythmias
• Myocardial irritability
• Pericardial effusion
• Pericardial rub
• Pulmonary edema
• Rise in threshold and exit block
• Valve damage
• Cardiac/coronary sinus dissection (Anthem, Anthem RF devices only)
• Cardiac/coronary sinus perforation (Anthem, Anthem RF devices only)
• Coronary sinus or cardiac vein thrombosis (Anthem, Anthem RF devices
only)
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1-14 Clinician Use Information
14 Clinician Use Information
Clinician Use Information
Programming Guidelines
General
For a list of all programmable parameters and settings, refer to the program-
mer’s on-screen help.
Magnet Use
To interrogate the device, remove the magnet from the programmer telemetry
wand. A magnet will interfere with proper telemetry.
Temporary Programming
These devices feature Temporary Programming to aid the clinician in diagnos-
ing and treating the patient. The clinician can temporarily program parameters
to assess their effects with the ability to quickly cancel or permanently program
the setting. For more information, refer to the programmer’s on-screen help.
Preset Programmed Settings
Shipped Settings
The device’s parameter settings are preset when the device is manufactured.
For additional information, refer to the programmer’s on-screen help.
WARNING
The default Atrial Sensitivity setting and the
lowest possible setting of Ventricular Sensi-
tivity, 0.2 mV, may be more susceptible to
EMI, according to testing required by
CENELEC standard prEN45502-2-2. The devices
comply with the electromagnetic compatibil-
ity requirements of CENELEC standard
prEN45502-2-2 at atrial and ventricular sensi-
tivities of 0.3 mV and less sensitive settings.
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XXXX XXXX XXXX Reference Manual 1-15
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 15
Emergency Settings
The device is equipped with standard, high-output settings that can be quickly
programmed using the programmer’s Emergency VVI function. Settings for
Emergency VVI can be found in the programmer’s on-screen help.
Radiopaque Identification
Each device has an X-ray absorptive marker for noninvasive identification. The
marker consists of the St. Jude Medical logo (SJM) and a two-letter model
code. (See Table 4.)
Implantation and Lead Connection
Package Contents
Devices are shipped in a sterile box containing:
• One device
• Two IS-1 header plugs for sealing unused ports (Anthem™, Anthem RF
devices only)
• Connector kit containing:
- Torque wrench
• Literature.
Lead Connection
These devices accept unipolar or bipolar IS-1 short terminal pin leads. Prior to
implantation, make sure leads fit easily and snugly into the device header.
These devices have a single setscrew for each lead pin. The setscrew makes
Note
When Emergency VVI is selected, diagnostic data
are cleared from memory without a warning.
Device Model X-ray ID
Model Code
PM1110, PM1210, PM2110, PM2210, PM3110,
PM3210
HI
Table 4. X-ray ID codes for Accent™, Accent RF, Anthem™, Anthem RF devices
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1-16 Implantation and Lead Connection
16 Implantation and Lead Connection
contact with the pin (cathode) securing the lead within the connector while an
annular spring makes contact with the proximal ring (anode).
To connect the device to the leads:
1. Remove blood and body fluids from the terminal pins of the
implanted leads.
2. Check the markings on the device case and verify proper atrial and
ventricular connections.
Note
Enter the lead types for each lead on the Patient
Information screen. For additional information,
refer to the programmer’s on-screen help.
CAUTION
After all leads have been implanted and before
they are connected to the device, establish and
document the baseline morphology for capture
and sensing thresholds for each lead using a suit-
able recording system, such as a 12-lead ECG or Int-
racardiac Electrogram (IEGM)
CAUTION
In Anthem™ and Anthem RF devices, pairing a ven-
tricular lead with a polished platinum tip electrode
with a lead with a tip electrode of a different
material may create a source impedance mismatch
that could adversely affect sensing. Use only
St. Jude Medical™ leads as the left ventricular lead
in Anthem and Anthem RF devices.
CAUTION
Exercise caution when turning the setscrew, which
may be backed out of the connector if turned
counterclockwise for more than two rotations.
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XXXX XXXX XXXX Reference Manual 1-17
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 17
3.
4. Use the torque wrench packaged with the device to retract the set-
screws in the device connector so that the pacing lead terminal pins
can be fully inserted.
5. Insert the lead pin firmly into the connector until it is immobile and
visible in the viewport at the opposite end of the connector.
6. Insert the torque wrench through the aperture on the header and
into the setscrew on the side of the connector.
7. Turn the torque wrench clockwise until it clicks. The wrench is
torque-limited and will not allow excessive tightening.
8. Repeat Steps 5 through 7 for additional lead(s).
9. Tug gently on the leads to ensure they are securely connected to the
device.
In order to minimize device migration, secure the device to the subcutaneous
pocket via the suture hole in the device header.
After the device has been implanted and the pocket is closed, interrogate the
device and set the Lead Type to the correct setting. Lead Type settings are
described on the programmer’s on-screen help.
Note
In Anthem and Anthem RF devices: For proper
sensing and pacing, it is important to ensure that
left and right ventricular signals are correctly
detected and that pacing pulses are delivered in
the desired chamber.
Note
In Anthem and Anthem RF devices, the right and
left ventricular pulse amplitudes and pulse widths
are independently programmable. The pulse ampli-
tude and pulse width should be evaluated in each
chamber accordingly.
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1-18 Device Registration
18 Device Registration
Device Registration
An Implantable Device Registration Form is enclosed with each device to serve
as a permanent record of information pertaining to the implanted device. The
completed original should be returned to the manufacturer in the postage-
paid, addressed envelope provided. Copies of the registration form are pro-
vided for the hospital and the physician.
Device Longevity
For estimated longevity calculations, see the programmer’s on-screen help.
Elective Replacement Indicator
ERI (or Recommended Replacement Time) is the point at which battery voltage
has dropped to the lowest capacity that will maintain adequate device opera-
tion for a nominal period of three months before EOL.
When the device reaches ERI, a number of indicators alert the clinician to this
condition. For information on these conditions, refer to the programmer’s on-
screen help.
Clearing ERI
When the programmer displays a message that the device has reached ERI, you
are able to clear ERI. For additional information on Clearing ERI, refer to the
programmer’s on-screen help.
Note
Careful consideration should be given to patient
exposure to electromagnetic interference if pro-
gramming sensitivity greater than 0.5 mV with a
bipolar sense configuration setting and 2.0 mV
with a unipolar sense configuration setting.
Note
In Anthem and Anthem RF devices, independent
lead impedance values are displayed for the RV
and LV leads.
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XXXX XXXX XXXX Reference Manual 1-19
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 19
End-of-Life
End-of-Life (EOL) occurs when the battery voltage has fallen to approximately
2.5 V. For additional information, refer to the programmer’s on-screen help.
Technical Service
St. Jude Medical Cardiac Rhythm Management Division maintains 24-hour
phone lines for technical questions and support:
• 1 818 362 6822
• 1 800 722 3774 (toll-free within North America)
• + 46 8 474 4147 (Sweden)
For additional assistance, call your local St. Jude Medical representative.
Additional Information
For additional information on this device, refer to the programmer’s on-screen
help.
CAUTION
Programming to high output settings with a high
Base Rate may shorten the time to ERI. Program-
ming to lower rates and outputs may restore nor-
mal battery status.
If the programmer displays an ERI warning mes-
sage, the clinician should fully evaluate the device.
WARNING
At ERI, the nominal life of the device is three
months. When the device exhibits signs of
ERI (described on the programmer’s on-
screen help), it should be replaced expedi-
tiously.
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1-20 Physical Specifications
20 Physical Specifications
Physical Specifications
PM1110 PM2110 PM1210 PM2210
Case Material Titanium Titanium Titanium Titanium
Case Coating None None None None
RF Antenna
Material
None None Titanium Titanium
Connector Material Epoxy Epoxy Epoxy Epoxy
Dimensions1 (mm)
1. These values are nominal.
42(h) x 52(l) x
6(t)
46(h) x 52(l) x
6(t)
52(h) x 52(l) x
6(t)
52(h) x 52(l)
x 6(t)
Weight 1 (g) 18 19 23 23
Volume2 (cm3)
2. ± 0.5 cm3
9.5 10.5 12.8 12.8
Lead Connector IS-13
3. Accepts IS-1 short terminal pin leads.
IS-1 3IS-1 3IS-1 3
Table 5. Accent™, Accent RF physical specifications
PM3110 PM3210
Case Material Titanium Titanium
Case Coating None None
RF Antenna Material None Titanium
Connector Material Epoxy Epoxy
Dimensions1 (mm)
1. These values are nominal.
52(h) x 52(l) x 6(t) 58(h) x 52(l) x 6(t)
Weight 1 (g) 21 25
Volume2 (cm3)
2. ± 0.5 cm3
11.5 13.7
Lead Connector IS-13
3. Accepts IS-1 short terminal pin leads.
IS-1 3
Table 6. Anthem™, Anthem RF devices physical specifications
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XXXX XXXX XXXX Reference Manual 1-21
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 21
Battery Information
RF Operating Frequencies
Nearby equipment emitting strong magnetic fields can interfere with RF com-
munication, even if the other equipment complies with CISPR emission require-
ments. The operating characteristics are as follows:
MICS band: 402-405 MHz. The effective radiated power is below the limits as
specified in:
• Europe: EN ETSI 301 839-2
• USA: FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219.
• FCC ID: RIASJMRFB.
PM1110, PM2110, PM3110
Power source 1 QMR cell
Manufacturer Wilson Greatbatch Ltd. USA
Model 2662
Voltage at BOL 3.2 V
Voltage at ERI 2.6 V
Table 7. Battery Information
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1-22 Temperature Effects
22 Temperature Effects
Temperature Effects
WARNING
This transmitter is authorized by rule under
the Medical Implant Communications Service
(part 95 of the FCC Rules) and must not cause
harmful interference to stations operating in
the 400.150 - 406.000 MHz band in the Meteo-
rological Aids (that is, transmitters and
receivers used to communicate weather
data), the Meteorological Satellite, or the
Earth Exploration Satellite Services and must
accept interference that may be caused by
such aids, including interference that may
cause undesired operation. This transmitter
shall be used only in accordance with the FCC
Rules governing the Medical Implant Commu-
nications Service. Analog and digital voice
communications are prohibited. Although
this transmitter has been approved by the
Federal Communications Commission, there
is no guarantee that it will not receive inter-
ference or that any particular transmission
from this transmitter will be free from inter-
ference.
Parameter1
1. Parameter value deviation from 37°C.
at 20°C at 43°C
Base Rate < ± 1% < ± 1%
Test Rate < ± 1% < ± 1%
Pulse Width < ± 1% < ± 1%
Pulse Amplitude < ± 5% < ± 2%
Sensitivity < ± 5% < ± 2%
Table 8. Maximum Temperature Effect on Different Parameters
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XXXX XXXX XXXX Reference Manual 1-23
Accent™, Accent RF, Anthem™, Anthem RF Devices User’s Manual 23
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1-24 Temperature Effects
24 Temperature Effects
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January 2009
Art 60020471/A
Cardiac Rhythm Management Division
15900 Valley View Court
Sylmar, CA 91342 USA
+1 818 362 6822
701 E. Evelyn Avenue
Sunnyvale, CA 94086 USA
+1 408 738 4883
Veddestavägen 19
SE-175 84 Järfälla
Sweden
+46 8 474 4000
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