St. Jude Medical Ellipse VR User manual

Ellipse™
Tiered-therapy Cardioverter/Defibrillator
Fortify Assura™
Tiered-therapy Cardioverter/Defibrillator
Quadra Assura™
Cardiac Resynchronization Device Tiered-therapy Cardioverter/Defibrillator
Unify Assura™
Cardiac Resynchronization Device Tiered-therapy Cardioverter/Defibrillator

Covered by one or more of the following US patents: 5 318 591
Proposition 65 a State of California voter initiative requires the following notice:
WARNING: This product and its packaging have been sterilized with
ethylene oxide. This packaging may expose you to
ethylene oxide a chemical known to the state of California to cause cancer or birth defects or other reproductive harm.
ST. JUDE MEDICAL the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered
trademarks and service marks of St. Jude Medical Inc. and its related companies.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
© 2012 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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Device Description
Device DescriptionDevice Description
Device Description
This manual describes the following St. Jude Medical
®
pulse generators:
Table 1. Single-chamber pulse-generator descriptions
Name
NameName
Name Model Number
Model NumberModel Number
Model Number Description
DescriptionDescription
Description Connector Type
Connector TypeConnector Type
Connector Type Delivered
Delivered Delivered
Delivered
Energy
Energy Energy
Energy
(approx.)
(approx.)(approx.)
(approx.)
Ellipse VR CD1275-36 Single-chamber ICD
with RF telemetry
DF-1/IS-1 36 J
Ellipse VR CD1275-36Q Single-chamber ICD
with RF telemetry
DF4-LLHH 36 J
Fortify Assura
VR
CD1257-40 Single-chamber ICD
with RF telemetry
DF-1/IS-1 40 J

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Table 1. Single-chamber pulse-generator descriptions
Fortify Assura
VR
CD1257-40Q Single-chamber ICD
with RF telemetry
DF4-LLHH 40 J
Ellipse VR CD1311-36 Single-chamber ICD
with RF telemetry
DF-1/IS-1 36 J
Ellipse VR CD1311-36Q Single-chamber ICD
with RF telemetry
DF4-LLHH 36 J

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Table 2. Dual-chamber pulse-generator descriptions
Name
NameName
Name Model Number
Model NumberModel Number
Model Number Description
DescriptionDescription
Description Connector Type
Connector TypeConnector Type
Connector Type Delivered
Delivered Delivered
Delivered
Energy
Energy Energy
Energy
(approx.)
(approx.)(approx.)
(approx.)
Ellipse DR CD2275-36 Dual-chamber ICD with
RF telemetry
DF-1/IS-1 36 J
Ellipse DR CD2275-36Q Dual-chamber ICD with
RF telemetry
DF4-LLHH/
IS-1
36 J
Fortify Assura
DR
CD2257-40 Dual-chamber ICD with
RF telemetry
DF-1/IS-1 40 J
Fortify Assura
DR
CD2257-40Q Dual-chamber ICD with
RF telemetry
DF4-LLHH/
IS-1
40 J
Ellipse DR CD2311-36 Dual-chamber ICD with
RF telemetry
DF-1/IS-1 36 J
Ellipse DR CD2311-36Q Dual-chamber ICD with
RF telemetry
DF4-LLHH/
IS-1
36 J

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Table 3. CRT-D pulse-generator descriptions
Name
NameName
Name Model Number
Model NumberModel Number
Model Number Description
DescriptionDescription
Description Connector Type
Connector TypeConnector Type
Connector Type Delivered
Delivered Delivered
Delivered
Energy
Energy Energy
Energy
(approx.)
(approx.)(approx.)
(approx.)
Quadra Assura CD3265-40 CRT-D with
RF telemetry
DF-1/IS-1/
IS4-LLLL
40 J
Quadra Assura CD3265-40Q CRT-D with
RF telemetry
DF4-LLHH/
IS4-LLLL/
IS-1
40 J
Unify Assura CD3257-40 CRT-D with
RF telemetry
DF-1/IS-1/
IS4-LLLL
40 J
Unify Assura CD3257-40Q CRT-D with
RF telemetry
DF4-LLHH/
IS4-LLLL/
IS-1
40 J
The pulse generator along with compatible commercially available leads constitutes the implantable
portion of the ICD and CRT-D systems. The lead systems are implanted using either transvenous or

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transthoracic techniques. The St. Jude Medical Merlin
®
Patient Care System (PCS) with software model
3330 version 14.1.1 (or greater) a Merlin
®
Antenna (for devices with RF communication) and a
telemetry wand constitute the external portion of the ICD and CRT-D systems.
Models with the “Q” suffix” are functionally equivalent in all respects to the same model without the “Q”
suffix except for the header. Models without the Q” suffix use DF-1 lead connectors for the high-voltage
leads and models with the Q” suffix use a single DF4-LLHH lead connector for the high-voltage leads
and for the low voltage RV lead.
SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connectors comply with ISO 27186:2010(E).SJ4-
LLLL is equivalent to IS4-LLLL. SJ4 and IS4 connectors comply with ISO 27186:2010(E).
I
II
Indications and Usage
ndications and Usagendications and Usage
ndications and Usage
St. Jude Medical
®
ICDs and CRT-Ds are intended to provide ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in
patients with the above ICD indication and sinus node dysfunction.
In patients indicated for an ICD CRT-Ds are also intended:
to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class

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III or IV) in those patients who remain symptomatic despite stable optimal medical therapy (as
defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left
ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration
to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal
ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure
Contrai
ContraiContrai
Contraindications
ndicationsndications
ndications
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
Warnings and PrecautionsWarnings and Precautions
Warnings and Precautions
Resuscitation Availability. Do not perform device testing unless an external defibrillator and medical
personnel skilled in cardiopulmonary resuscitation (CPR) are readily available.
Lead system. Do not use another manufacturer’s lead system without demonstrated compatibility as
undersensing cardiac activity and failure to deliver necessary therapy may result.
Avoiding shock during handling. Disable tachyarrhythmia therapy (Enable/ Disable Tachy Therapy) or
program tachyarrhythmia therapies Off during surgical implant and explant or post-mortem procedures
as well as when disconnecting leads as the device can deliver a serious shock if you touch the

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defibrillation terminals while the device is charged.
Additional pacemaker implanted. 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.
Modifying the device. 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.
Suboptimal radio frequency (RF communication. The Merlin PCS indicates the quality of the RF
communication by the telemetry strength indicator LEDs on both the Merlin PCS and the Merlin
Antenna. Below is a list of potential causes to suboptimal radio communication:
Table 4. Possible causes and solutions for suboptimal RF
communication
Possib
PossibPossib
Possible Causes
le Causesle Causes
le Causes Solutions
SolutionsSolutions
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.

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Table 4. Possible causes and solutions for suboptimal RF
communication
Possib
PossibPossib
Possible Causes
le Causesle Causes
le Causes Solutions
SolutionsSolutions
Solutions
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.

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Sterilization Storage and Handling
Sterilization Storage and HandlingSterilization Storage and Handling
Sterilization Storage and Handling
Resterilization. Do not resterilize and re-implant explanted pulse generators.
Use before date. Do not implant the device after the "use before" date because the battery may have
reduced longevity.
If package is damaged. Do not use the device or accessories if the packaging is wet punctured opened
or damaged because the integrity of the sterile packaging may be compromised. Return the device to
St. Jude Medical.
Device storage. Store the device in a clean area away from magnets kits containing magnets and
sources of electromagnetic interference to avoid device damage. Store the device between 10° and 45°C
because temperatures outside this range may damage the device.
Temperature Equilibration. 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.
Follow
FollowFollow
Follow-
--
-up Testing
up Testingup Testing
up Testing
Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation
(CPR) are present during post-implant device testing should the patient require external rescue.

10
Be aware that the changes in the patient's condition drug regimen and other factors may change the
defibrillation threshold (DFT) which may result in nonconversion of the arrhythmia. Successful
conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no
assurance that conversion will occur post-operatively.
Implantation and Device Programming
Implantation and Device ProgrammingImplantation and Device Programming
Implantation and Device Programming
Do not position a magnet over the device as that suspends detection and treatment (unless the device
has been programmed to ignore the magnet).
Replace the device when the battery reaches the elective replacement indicator (ERI).
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.
Exercise caution when turning the setscrew which may be backed out of the connector if turned
counterclockwise for more than two rotations.
Program the device parameters as specified in the Merlin
®
PCS on-screen help.
The results of the DAVID Study demonstrated that for patients with standard indications for ICD therapy
no indication for cardiac pacing and an EF < 40% dual-chamber pacing offers no clinical advantage
over backup VVI pacing and may be associated with worsening heart failure.
1
When programming the
1
Wilkoff BL Cook JR Epstein AE Greene L Hallstrom AP Hsia H Kutalek SP Sharma A. Dual-Chamber Pacing or Ventricular Backup
Pacing in Patients With an Implantable Defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. December
25 2002; Vol 288 No. 24:3115-3123.

11
device to dual-chamber pacing modes give particular attention to setting the pacing parameters (such
as the A-V delay) to promote intrinsic conduction and minimize the amount of ventricular pacing.
Pulse Generator Explant and Disposal
Pulse Generator Explant and DisposalPulse Generator Explant and Disposal
Pulse Generator Explant and Disposal
Interrogate the device and turn all therapies off before explanting cleaning or shipping the device to
prevent unwanted shocks.
Return all explanted pulse generators and leads to St. Jude Medical.
Never incinerate the device because of the potential for explosion. Explant the device before cremation.
Environmental and Medical Therapy Hazards
Environmental and Medical Therapy HazardsEnvironmental and Medical Therapy Hazards
Environmental and Medical Therapy Hazards
Instruct patients to avoid devices which generate a strong electric or magnetic interference (EMI). EMI
could cause device malfunction or damage resulting in non-detection or delivery of unneeded therapy.
Moving away from the source or turning it off will usually allow the pulse generator to return to its normal
mode of operation.
Hospital and Medical Environments
Hospital and Medical EnvironmentsHospital and Medical Environments
Hospital and Medical Environments
Electrosurgical cautery. Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation
or may cause device malfunction or damage. If electrocautery is necessary keep the current path and
groundplate as far away from the pulse generator and leads as possible.

12
External defibrillation. External defibrillation may damage the pulse generator or may result in
temporary and/or permanent myocardial damage at the electrode-tissue interface as well as temporarily
or permanently elevated pacing capture thresholds. Minimize current flowing through the pulse
generator and lead system by following these precautions when using external defibrillation on a patient
with a pulse generator:
Position defibrillation paddles as far from the pulse generator as possible (minimum of 13 cm)
Use the lowest clinically appropriate energy output
Confirm pulse generator function following any external defibrillation
High radiation sources. Do not direct high radiation sources such as cobalt 60 or gamma radiation at
the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator place
lead shielding over the device to prevent radiation damage and confirm its function after treatment.
Lithotripsy. Lithotripsy may permanently damage the pulse generator. Avoid it unless the therapy site is
not near the pulse generator and leads.
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.
Magnetic resonance imaging (MRI . MRI for patients with implantable pulse generators has been
contraindicated by MRI manufacturers. Clinicians should carefully weigh the decision to use MRI with
ICD/CRT-D patients. MRI may cause device malfunction or injury to the patient.
Ultrasound therapy. Diagnostic and therapeutic ultrasound treatment is not known to affect the function

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of the pulse generator.
Transcutaneous Electrical Nerve Stimulation (TENS . TENS may interfere with device function. To
reduce interference place the TENS electrodes close to one another and as far from the device/lead
system as possible. Monitor cardiac activity during TENS use.
RF Operating Frequencies. Nearby equipment emitting strong magnetic fields can interfere with RF
communication even if the other equipment complies with CISPR emission requirements. 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: RIASJMRF.
The following is applicable to Canada only:
This device may not interfere with stations operating in the 400.150-406.000 MHz band in the
meteorological aids meteorological-satellite and earth exploration-satellite services and must accept any
interference received including interference that may cause undesired operation.
WARNING
WARNINGWARNING
WARNING
This transmitter is authorized by rule under the Medical Implant Communications
This transmitter is authorized by rule under the Medical Implant Communications This transmitter is authorized by rule under the Medical Implant Communications
This transmitter is authorized by rule under the Medical Implant Communications
Service (part 95 of the FCC Rules) an
Service (part 95 of the FCC Rules) anService (part 95 of the FCC Rules) an
Service (part 95 of the FCC Rules) and must not cause harmful interference to stations
d must not cause harmful interference to stations d must not cause harmful interference to stations
d must not cause harmful interference to stations
operating in the 400.150
operating in the 400.150 operating in the 400.150
operating in the 400.150 -
--
- 406.000 MHz band in the Meteorological Aids (that is
406.000 MHz band in the Meteorological Aids (that is 406.000 MHz band in the Meteorological Aids (that is
406.000 MHz band in the Meteorological Aids (that is

14
transmitters and receivers used to communicate weather data) the Meteorological
transmitters and receivers used to communicate weather data) the Meteorological transmitters and receivers used to communicate weather data) the Meteorological
transmitters and receivers used to communicate weather data) the Meteorological
Satellite or the Earth Exploration Satellit
Satellite or the Earth Exploration SatellitSatellite or the Earth Exploration Satellit
Satellite or the Earth Exploration Satellite Services and must accept interference that
e Services and must accept interference that e Services and must accept interference that
e Services and must accept interference that
may be caused by such aids including interference that may cause undesired
may be caused by such aids including interference that may cause undesired may be caused by such aids including interference that may cause undesired
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
operation. This transmitter shall be used only in accordance with the FCC Rules operation. This transmitter shall be used only in accordance with the FCC Rules
operation. This transmitter shall be used only in accordance with the FCC Rules
governing the Medical Implant Communications Service. A
governing the Medical Implant Communications Service. Agoverning the Medical Implant Communications Service. A
governing the Medical Implant Communications Service. Analog and digital voice
nalog and digital voice nalog and digital voice
nalog and digital voice
communications are prohibited. Although this transmitter has been approved by the
communications are prohibited. Although this transmitter has been approved by the communications are prohibited. Although this transmitter has been approved by the
communications are prohibited. Although this transmitter has been approved by the
Federal Communications Commission there is no guarantee that it will not receive
Federal Communications Commission there is no guarantee that it will not receive Federal Communications Commission there is no guarantee that it will not receive
Federal Communications Commission there is no guarantee that it will not receive
interference or that any particular transmission from this transmitt
interference or that any particular transmission from this transmittinterference or that any particular transmission from this transmitt
interference or that any particular transmission from this transmitter will be free from
er will be free from er will be free from
er will be free from
interference.
interference.interference.
interference.
Radiofrequency ablation. RF ablation in a patient with a pulse generator may cause device malfunction
or damage.
Minimize RF ablation risks by:
Programming all tachyarrhythmia therapies off
Avoiding direct contact between the ablation catheter and the implanted lead or pulse generator
Positioning the groundplate so that the current pathway does not pass near the pulse generator
system i.e. place the groundplate under the patient's buttocks or legs
Having external defibrillation equipment available.

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Home and Occupational Environments
Home and Occupational EnvironmentsHome and Occupational Environments
Home and Occupational Environments
High-voltage power transmission lines. High-voltage power transmission lines may generate enough
EMI to interfere with pulse generator operation if approached too closely.
Communication equipment. Communication equipment such as microwave transmitters or high-power
amateur transmitters may generate enough EMI to interfere with pulse generator operation if approached
too closely.
Home appliances. Home appliances in good working order and properly grounded do not usually
produce enough EMI to interfere with pulse generator operation. There are reports of pulse generator
disturbances caused by electric hand tools or electric razors used directly over the pulse generator
implant site.
Industrial equipment. A variety of industrial equipment produce EMI of sufficient field strength and
modulation characteristics to interfere with proper operation of the pulse generator. These include but
are not limited to: arc welders; induction furnaces; very large or defective electric motors; and internal
combustion engines with poorly shielded ignition systems.
Electronic Article Surveillance
Electronic Article SurveillanceElectronic Article Surveillance
Electronic Article Surveillance
Advise patients that the Electronic Article Surveillance/Anti-theft (EAS) systems such as those at the
point of sale and entrances/exits of stores libraries banks etc. emit signals that may interact with the
device. It is very unlikely that these systems will interact with their device significantly. However to

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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
Metal DetectorsMetal Detectors
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
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 the patient should ask that they perform the search quickly stressing that
they should avoid holding the wand over the device for a prolonged period.
Cellular Phones
Cellular PhonesCellular Phones
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.

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Potential Adverse Events
Potential Adverse EventsPotential Adverse Events
Potential Adverse Events
Possible adverse events (in alphabetical order) associated with the system include but are not limited to
the following:
Acceleration of arrhythmias (caused by device)
Air embolism
Allergic reaction
Bleeding
Cardiac tamponade
Chronic nerve damage
Death
Erosion
Exacerbation of heart failure
Excessive fibrotic tissue growth
Extracardiac stimulation (phrenic nerve diaphragm chest wall)
Extrusion
Fluid accumulation
Formation of hematomas or cysts
Inappropriate shocks

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Infection
Keloid formation
Lead abrasion and discontinuity
Lead migration/dislodgment
Myocardial damage
Pneumothorax
Shunting current or insulating myocardium during defibrillation with internal or external paddles
Potential mortality due to inability to defibrillate or pace
Thromboemboli
Venous occlusion
Venous or cardiac perforation.
Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop
psychological intolerance to an ICD or CRT-D system that may include the following:
Dependency
Depression
Fear of premature battery depletion
Fear of shocking while conscious
Fear of losing shock capability
Imagined shocking (phantom shock).