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Table of Contents
- 1 Device Description
- 2 Warnings and Precautions
- 3 Follow up Testing
- 4 Pulse Generator Explant and Disposal
- 5 Environmental and Medical Therapy Hazards
- 6 Hospital and Medical Environments
- 7 Cellular Phones
- 8 Potential Adverse Events
- 9 Physician Training
- 10 Device Storage
- 11 Directions for Use
- 12 Technical Support
- 13 Additional Information
- Download this manual
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Table of Contents
Related Manuals for St. Jude Medical Ellipse VR
Summary of Contents for St. Jude Medical Ellipse VR
- Page 1 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...
- Page 2 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.
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Page 3: Device Description
Connector Type Connector Type Delivered Delivered Energy Energy Energy Energy (approx.) (approx.) (approx.) (approx.) Single-chamber ICD Ellipse VR CD1275-36 DF-1/IS-1 36 J with RF telemetry Ellipse VR CD1275-36Q Single-chamber ICD DF4-LLHH 36 J with RF telemetry Fortify Assura Single-chamber ICD... - Page 4 Table 1. Single-chamber pulse-generator descriptions Fortify Assura CD1257-40Q Single-chamber ICD DF4-LLHH 40 J with RF telemetry Ellipse VR CD1311-36 Single-chamber ICD DF-1/IS-1 36 J with RF telemetry Single-chamber ICD Ellipse VR CD1311-36Q DF4-LLHH 36 J with RF telemetry...
- Page 5 Table 2. Dual-chamber pulse-generator descriptions Delivered Delivered Name Name Name Name Model Number Model Number Model Number Model Number Description Description Description Description Connector Type Connector Type Connector Type Connector Type Delivered Delivered Energy Energy Energy Energy (approx.) (approx.) (approx.) (approx.) Ellipse DR CD2275-36...
- Page 6 Table 3. CRT-D pulse-generator descriptions Delivered Delivered Name Name Name Name Model Number Model Number Model Number Model Number Description Description Description Description Connector Type Connector Type Connector Type Connector Type Delivered Delivered Energy Energy Energy Energy (approx.) (approx.) (approx.) (approx.) Quadra Assura CD3265-40...
- Page 7 ® 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”...
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Page 8: Warnings And Precautions
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... - Page 9 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.
- Page 10 Table 4. Possible causes and solutions for suboptimal RF communication Possib Possible Causes Possib Possib le Causes le Causes le Causes Solutions Solutions Solutions Solutions People or objects interfere with Make sure that the space the communication between the between the Merlin Antenna Merlin Antenna and the device.
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Page 11: Follow Up Testing
Sterilization, Storage and Handling Sterilization, Storage and Handling Sterilization, 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. - Page 12 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.
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Page 13: Pulse Generator Explant And Disposal
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 Disposal Pulse 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. - Page 14 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...
- Page 15 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.
- Page 16 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 Satellite Services and must accept interference that Satellite, or the Earth Exploration Satellit...
- Page 17 Home and Occupational Environments Home and Occupational Environments Home 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.
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Page 18: Cellular Phones
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 Detectors Metal 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. -
Page 19: Potential Adverse Events
Potential Adverse Events Potential Adverse Events Potential 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... - Page 20 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...
- Page 21 Clinic Clinician Use Information Clinic Clinic ian Use Information ian Use Information ian Use Information WARNING WARNING WARNING WARNING For devices without the Low Frequency Attenuation Filter, the default Atrial Sensitivity For devices without the Low Frequency Attenuation Filter, the default Atrial Sensitivity For devices without the Low Frequency Attenuation Filter, the default Atrial Sensitivity For devices without the Low Frequency Attenuation Filter, the default Atrial Sensitivity setting and the lowest possible setting of Ventricular Sensitivity, 0.2...
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Page 22: Physician Training
Physician Training Physician Training Physician Training Physician Training Physicians should be familiar with sterile pulse generator implant procedure and with follow-up evaluation and management of patients with an ICD or CRT-D (or should refer the patient to such a physician). Maintaining Device Effectiveness Maintaining Device Effectiveness Maintaining Device Effectiveness... -
Page 23: Directions For Use
An electrical reset condition may occur at temperatures below -20°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. Its "use before" date has expired, because this can adversely affect pulse generator longevity or device sterility. - Page 24 Table 5. X-ray ID codes for the device models described in this manual Device Model Device Model Device Model Device Model X X X X - - - - ray ray ID Model Code ID Model Code ID Model Code ID Model Code CD1275-36/36Q, CD1311-36/36Q, CD2275-36/36Q, CD2311- 36/36Q...
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Page 25: Technical Support
Technical Support Technical Support Technical Support Technical Support 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. - Page 28 Cardiac Rhythm Management Division 15900 Valley View Court Veddestavägen 19 Sylmar, CA 91342 USA SE-175 84 Järfälla +1 818 362 6822 Sweden +46 8 474 4000 sjm.com April 2012 Art 60031731/A...
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