St. Jude Medical Ellipse User Manual
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St. Jude Medical Ellipse User Manual

Tiered-therapy cardioverter/defibrillator
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Ellipse™
Fortify Assura™
Tiered-therapy Cardioverter/Defibrillator
Quadra Assura™, Quadra Assura MP™
Unify Assura™
Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator

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Larry Rogers
February 4, 2025

What does it mean when the device vibrates twice. Md# cd3369-40q

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Summary of Contents for St. Jude Medical Ellipse

  • Page 1 Ellipse™ Fortify Assura™ Tiered-therapy Cardioverter/Defibrillator Quadra Assura™, Quadra Assura MP™ Unify Assura™ Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator...
  • Page 2 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 and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies.

  • Page 3: Device Description

    Device Description This manual describes the following St. Jude Medical™ pulse generators: Table 1. Single-chamber pulse-generator descriptions Name Model Number Description Connector Type Delivered MRI Status Energy (approx.) Fortify Assura CD1257-40 Single-chamber ICD DF-1/IS-1 40 J Untested with RF telemetry...
  • Page 4 Table 1. Single-chamber pulse-generator descriptions Name Model Number Description Connector Type Delivered MRI Status Energy (approx.) Ellipse VR CD1311-36 Single-chamber ICD DF-1/IS-1 36 J Untested with RF telemetry Ellipse VR CD1311-36Q Single-chamber ICD DF4-LLHH 36 J with RF telemetry Conditional...
  • Page 5 Table 1. Single-chamber pulse-generator descriptions Name Model Number Description Connector Type Delivered MRI Status Energy (approx.) Ellipse VR CD1411-36 Single-chamber ICD DF-1/IS-1 36 J Untested with RF telemetry Ellipse VR CD1411-36C Single-chamber ICD DF-1/IS-1 36 J Untested with RF telemetry,...
  • Page 6 Dual-chamber ICD DF-1/IS-1 40 J Untested with RF telemetry Fortify Assura CD2257-40Q Dual-chamber ICD DF4-LLHH/IS-1 40 J Untested with RF telemetry Ellipse DR CD2275-36 Dual-chamber ICD DF-1/IS-1 36 J Untested with RF telemetry Ellipse DR CD2275-36Q Dual-chamber ICD DF4-LLHH/IS-1 36 J...
  • Page 7 40 J Untested with RF telemetry Fortify Assura CD2357-40QC Dual-chamber ICD DF4-LLHH/IS-1 40 J Untested with RF telemetry, Parylene coating Ellipse DR CD2411-36 Dual-chamber ICD DF-1/IS-1 36 J Untested with RF telemetry Ellipse DR CD2411-36C Dual-chamber ICD DF-1/IS-1 36 J...
  • Page 8 Table 2. Dual-chamber pulse-generator descriptions Name Model Number Description Connector Type Delivered MRI Status Energy (approx.) Ellipse DR CD2411-36Q Dual-chamber ICD DF4-LLHH/IS-1 36 J with RF telemetry Conditional Ellipse DR CD2411-36QC Dual-chamber ICD DF4-LLHH/IS-1 36 J with RF telemetry, Conditional Parylene coating Table 3.
  • Page 9 Table 3. CRT-D pulse generator descriptions Name Model Description Connector Type Delivered MR Status Number Energy (approx.) Unify CD3257-40 CRT-D with DF-1/IS-1 40 J Untested Assura RF telemetry Unify CD3257-40Q CRT-D with DF4-LLHH/IS-1 40 J Untested Assura RF telemetry Quadra CD3265-40 CRT-D with DF-1/IS-1/IS4-LLLL...
  • Page 10 Table 3. CRT-D pulse generator descriptions Name Model Description Connector Type Delivered MR Status Number Energy (approx.) Unify CD3357-40C CRT-D with DF-1/IS-1 40 J Untested Assura RF telemetry, Parylene coating Unify CD3357-40Q CRT-D with DF4-LLHH/IS-1 40 J Untested Assura RF telemetry Unify CD3357-40QC CRT-D with DF4-LLHH/IS-1...
  • Page 11 Table 3. CRT-D pulse generator descriptions Name Model Description Connector Type Delivered MR Status Number Energy (approx.) Quadra CD3365-40Q CRT-D with DF4-LLHH/IS4-LLLL/IS-1 40 J Untested Assura RF telemetry Quadra CD3365-40QC CRT-D with DF4-LLHH/IS4-LLLL/IS-1 40 J Untested Assura RF telemetry, Parylene coating Quadra CD3369-40 CRT-D with RF...
  • Page 12 ICD and CRT-D systems. The lead systems are implanted using either transvenous or transthoracic techniques. The St. Jude Medical Merlin™ Patient Care System (PCS) with software model 3330 version 24.0.1 (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.

  • Page 13: Indications And Usage

    LLLL is equivalent to IS4-LLLL. SJ4 and IS4 connectors comply with ISO 27186:2010(E). Indications 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.

  • Page 14: Warnings And Precautions

    MR Conditional system and according to instructions in the MRI Procedure Information document for the St. Jude Medical™ MR Conditional system. 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.
  • Page 15 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.

  • Page 16: Magnetic Resonance Imaging (Mri)

    MRI environment when used according to the instructions in the MRI Procedure Information document. The St. Jude Medical MR Conditional system includes a St. Jude Medical MR Conditional pulse generator connected to one or more St. Jude Medical MR Conditional leads.

  • Page 17: Sterilization, Storage And Handling

    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 (page 20) to avoid device damage.

  • Page 18: Implantation And Device Programming

    (CPR) are present during post-implant device testing should the patient require external rescue. 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.

  • Page 19: 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.
  • Page 20 groundplate as far away from the pulse generator and leads as possible. 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)
  • Page 21 device. 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. Radiofrequency ablation. RF ablation in a patient with a pulse generator may cause device malfunction or damage.

  • Page 22: Home And Occupational Environments

    FCC ID: RIASJMRF  WARNING: This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in 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 Meteorological 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 stations, including interference that...

  • Page 23: Electronic Article Surveillance, Security And Logistical Systems, And Metal Detectors

    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.

  • Page 24: Cellular Phones

    the ICD and CRT-D systems contain a 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 conduct 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.
  • Page 25 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 ...

  • Page 26: Clinician Use Information

    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 27: Physician Training

    For devices without the Low Frequency Attenuation Filter, the default Atrial Sensitivity setting and the lowest possible setting of Ventricular Sensitivity, 0.2 mV, may be more susceptible to EMI, according to testing required by CENELEC standard EN45502-2-2. The devices comply with the electromagnetic compatibility requirements of CENELEC standard EN45502-2-2 at atrial and ventricular sensitivities of 0.3 mV and less sensitive settings.

  • Page 28: Maintaining Device Effectiveness

    Device Storage FOR SINGLE USE ONLY. Do not resterilize and re-implant explanted pulse generators. St. Jude Medical has sterilized the pulse generator with ethylene oxide prior to shipment. Contact St. Jude Medical if resterilization is necessary. Do not implant the device when: It has been dropped on a hard surface because this could have damaged pulse generator ...
  • Page 29 Pulse generator operating characteristics should be verified at the time of implantation and recorded in the patient file. Complete the Patient Registration Form and return it to St. Jude Medical as it provides necessary information for warranty purposes and patient tracking.

  • Page 30: Package Contents

    Device Model X-ray ID Model Code CD1275-36/36Q, CD1311-36/36Q, CD1411-36/36C/36Q/36QC, CD2275-36/36Q, CD2311-36/36Q, CD2411-36/36C/36Q/36QC CD1257-40/40Q, CD2257-40/40Q, CD1357-40/40C/40Q/40QC, CD2357-40/40C/40Q/40QC, CD3257-40/40Q, CD3265-40/40Q, CD3357-40/40C/40Q/40QC, CD3365-40/40C/40Q/40QC, CD3269-40/40Q, 3369-40/40C/40Q/40QC Package Contents The pulse generator is supplied in a sterile tray for introduction into the operating field. The tray contains: One pulse generator (with all tachyarrhythmia therapies off) with pre-installed setscrews ...

  • Page 31: Technical Support

    Technical Support St. Jude Medical 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)  + 61 2 9936 1200 (Australia) ...
  • Page 34 St. Jude Medical St. Jude Medical Coordination Center BVBA Cardiac Rhythm The Corporate Village Management Division Da Vincilaan 11 Box F1 15900 Valley View Court 1935 Zaventem Sylmar, CA 91342 USA Belgium +1 818 362 6822 +32 2 774 68 11 sjm.com...

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