Zephyr™ SR Single-Chamber Rate-Responsive Pacemaker
CARDIOVASCULAR
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Zephyr SR

Single-Chamber Rate-Responsive Pacemaker

Zephyr SR

PRODUCT HIGHLIGHTS

  • Small, physiologic-shaped device maximises longevity without compromising size
  • Instant follow-up with automatic P- or R-wave, lead impedance measurements and threshold tests, resulting in 100% of follow-up completed before the patient arrives at the clinic
  • The AutoCapture pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat-by-Beatcapture confirmation
  • ACap confirm feature periodically completes a threshold search and adjusts the pulse amplitude accordingly in the atrium
  • Stored electrograms (EGMs) record a real-time EGM waveform as well as the associated event markers that precede and follow a specific triggering event
  • Automatic daily measurement and weekly trending of intrinsic P- or R-waves
  • Automatic lead impedance measurement. Display of weekly lead impedance trend, historical test results, pacing polarity and any polarity switches
  • Physiologic-based rest rate not subject to changes in time zone, daylight savings time or the patient’s schedule
  • Advanced hysteresis maximises opportunities for the patient’s own rhythm to prevail and addresses abrupt rate drops

ORDERING INFORMATION

Contents: Cardiac pulse generator


Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
5620 41 x 44 x 6 17 8 (± 0.5) IS-1
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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Indications and Usage: Implantation of Zephyr pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing (Models 5826, 5820 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 (Models 5826, 5820 only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. For specific indications associated with individual modes, refer to Operating Modes.

Contraindications: Zephyr devices are contraindicated in patients with an implanted cardioverterdefibrillator. 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. AF Suppression (Models 5826, 5820 only) stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation.

Dual-Chamber Pacing (Models 5826, 5820 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 ventricular 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 Operating Modes.

Potential Adverse Events: Adverse events associated with the use of any pacing system include: Air embolism, Bleeding Hematoma, Body rejection phenomena, Cardiac tamponade or perforation, Formation of fibrotic tissue, local tissue reaction, Inability to interrogate or program due to programmer or device malfunction, Infection/erosion, Interruption of desired pulse generator function due to electrical interference, 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 electrode/tissue interface, Loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation), Loss of normal device function due to battery failure or component malfunction, Pacemaker migration, pocket erosion or hematoma, Pectoralmuscle or diaphragmatic stimulation, Phrenic nerve stimulation, Pneumothorax/hemothorax.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

Item GMCRM910EN

Last Updated: January 02, 2019

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