User Manual
Table Of Contents
- 1. General description
- 2. Intended use and targeted population
- 3. Contraindications and adverse events
- 4. Warnings
- 5. Clinical studies
- 6. Patient selection and treatment
- 7. Patient counseling information
- 8. Declaration of conformity
- 9. Physician guidelines
- 10. Patient information
- 11. How supplied
- 12. Implant procedure
- 13. Pacemaker interrogation and upgrade
- 14. Special modes
- 15. Functions and parameters
- 16. Patient follow-up
- 17. Standby mode
- 18. Medical follow-up
- 19. Physical characteristics
- 20. Electrical characteristics
- 21. Programmable parameters
- 22. Non-programmable parameters
- 23. Warranty
- 24. Explanation of symbols
― symptomatic paroxysmal or transient sinus node dysfunctions with or without
associated AV conduction disorders;
― bradycardia-tachycardia syndrome to prevent symptomatic Bradycardia or some
forms of symptomatic tachyarrhythmias;
― vasovagal syndromes or hypersensitive carotid sinus syndromes.
― Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent
with increases in minute ventilation and/or activity.
Guidelines on cardiac pacing are provided by the European Society of Cardiology, the
American College of Cardiology and the American Heart Association ("2013 ESC Guidelines
on cardiac pacing and cardiac resynchronization therapy". Eur Heart J 2013;34:2281–2329,
“2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of
Cardiac Rhythm Abnormalities”. J Am Coll Cardiol. 2013; 61(3):e6-75).
2. INTENDED USE AND TARGETED POPULATION
12 ALIZEA – UA10414A