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
Necessary equipment............................................................................................... 30
Packaging contents .................................................................................................. 30
Optional equipment .................................................................................................. 30
Opening the package ............................................................................................... 30
Preparing the pocket ................................................................................................ 31
Choosing the type of lead......................................................................................... 32
Measurement of thresholds at implant ..................................................................... 32
Lead connections ..................................................................................................... 32
Implant considerations ............................................................................................. 33
13. PACEMAKER INTERROGATION AND UPGRADE ............................................... 34
14. SPECIAL MODES.................................................................................................... 35
Nominal mode (Safety mode)................................................................................... 35
Standby mode .......................................................................................................... 35
Magnet mode ........................................................................................................... 35
Response in the presence of interference................................................................ 35
15. FUNCTIONS AND PARAMETERS.......................................................................... 37
Pacing modes........................................................................................................... 37
Rates ........................................................................................................................ 37
Pacing and Sensing parameters .............................................................................. 38
Refractory periods .................................................................................................... 40
Rate response .......................................................................................................... 41
Therapeutic improvements....................................................................................... 43
Optimizing operation ................................................................................................ 46
Follow-up function .................................................................................................... 51
Remote monitoring function ..................................................................................... 51
16. PATIENT FOLLOW-UP ........................................................................................... 54
Recommended Replacement Time (RRT) ............................................................... 54
Follow-up recommendations .................................................................................... 54
Explantation.............................................................................................................. 55
Programmer tests..................................................................................................... 56
Interrogating the diagnostic data (AIDA) .................................................................. 56
Pacemaker identification .......................................................................................... 56
17. STANDBY MODE .................................................................................................... 58
18. MEDICAL FOLLOW-UP .......................................................................................... 59
Magnet test............................................................................................................... 59
Capture test mode:................................................................................................... 59
Rate test mode: ........................................................................................................ 60
Threshold tests......................................................................................................... 60
Lead measurements................................................................................................. 61
Statistics ................................................................................................................... 61
12.1.
12.2.
12.3.
12.4.
12.5.
12.6.
12.7.
12.8.
12.9.
14.1.
14.2.
14.3.
14.4.
15.1.
15.2.
15.3.
15.4.
15.5.
15.6.
15.7.
15.8.
15.9.
16.1.
16.2.
16.3.
16.4.
16.5.
16.6.
18.1.
18.2.
18.3.
18.4.
18.5.
18.6.
8 ALIZEA – UA10414A