User Manual

ManualsBrandsSORIN CRM ManualsElectronicsImplantable pacemaker with RF com.

Table Of Contents

1. General description
2. Intended use and targeted population
- 2.1. Intended use
- 2.2. Indications and targeted population
3. Contraindications and adverse events
- 3.1. General considerations
- 3.2. Adverse events, risks and side effects
4. Warnings
- 4.1. Pacemaker dependent patients
- 4.2. Warnings to patients
- 4.3. Risks related to medical environment
- 4.4. Storage
- 4.5. Packaging
  - 4.5.1. Characteristics of the sterile package
  - 4.5.2. Characteristics of the non-sterile package
5. Clinical studies
- 5.1. Methods
- 5.2. Patients studied
- 5.3. Safety results
- 5.4. Effectiveness results
6. Patient selection and treatment
- 6.1. Specific patient populations
7. Patient counseling information
8. Declaration of conformity
9. Physician guidelines
- 9.1. Physician training
- 9.2. Directions for use
- 9.3. Maintaining device quality
- 9.4. Implantation and device programming
- 9.5. Lead evaluation and lead connection
- 9.6. Programming and pacemaker operation
- 9.7. Rate increases
- 9.8. Generator explant and disposal
10. Patient information
11. How supplied
- 11.1. Sterility
- 11.2. Warranty and replacement policy
12. Implant procedure
- 12.1. Necessary equipment
- 12.2. Packaging contents
- 12.3. Optional equipment
- 12.4. Opening the package
- 12.5. Preparing the pocket
- 12.6. Choosing the type of lead
- 12.7. Measurement of thresholds at implant
- 12.8. Lead connections
- 12.9. Implant considerations
13. Pacemaker interrogation and upgrade
14. Special modes
- 14.1. Nominal mode (Safety mode)
- 14.2. Standby mode
- 14.3. Magnet mode
- 14.4. Response in the presence of interference
15. Functions and parameters
- 15.1. Pacing modes
  - 15.1.1. MRI Mode
- 15.2. Rates
- 15.3. Pacing and Sensing parameters
- 15.4. Refractory periods
- 15.5. Rate response
- 15.6. Therapeutic improvements
- 15.7. Optimizing operation
- 15.8. Follow-up function
- 15.9. Remote monitoring function
16. Patient follow-up
- 16.1. Recommended Replacement Time (RRT)
- 16.2. Follow-up recommendations
- 16.3. Explantation
- 16.4. Programmer tests
- 16.5. Interrogating the diagnostic data (AIDA)
  - 16.5.1. SafeR (Preservation of AV conduction)
- 16.6. Pacemaker identification
17. Standby mode
18. Medical follow-up
- 18.1. Magnet test
  - 18.1.1. Magnet On
  - 18.1.2. Magnet Off
- 18.2. Capture test mode:
- 18.3. Rate test mode:
- 18.4. Threshold tests
  - 18.4.1. Ventricular threshold test
  - 18.4.2. Atrial threshold test
- 18.5. Lead measurements
- 18.6. Statistics
- 18.7. Markers and intracardiac ECG
  - 18.7.1. Markers
  - 18.7.2. Intracardiac ECG
- 18.8. Temporary programming
- 18.9. Memory functions
19. Physical characteristics
20. Electrical characteristics
- 20.1. Current drain at beginning of service
- 20.2. Correspondence between magnet rate and battery life
- 20.3. Battery
- 20.4. Longevity
- 20.5. Radio equipment emission
21. Programmable parameters
- 21.1. Antibradycardia pacing
- 21.2. Remote alerts and warnings
22. Non-programmable parameters
23. Warranty
- 23.1. Article 1: Terms of warranty
- 23.2. Article 2: Terms of replacement
24. Explanation of symbols

Pacemaker sym-

bols

Explanation of sym-

bols

Cardiac resynchro-

nization therapy

pacemaker (RA, RV,

LV)

Pacemaker (dual

chamber, RA, RV)

Pacemaker (single

chamber, RV)

IS1 Connectors

(CRT-P)

IS1 connectors (dual

chamber)

IS1 connector (single

chamber)

Accelerometer

Minute ventilation

Sleep Apnea Moni-

toring (SAM)

MR Conditional

Full Body

Pacemaker sym-

bols

Explanation of sym-

bols

A-V interval

(paced/sensed)

Amplitude and pulse

width, RA, RV, LV

Amplitude and pulse

width, RA, RV

Amplitude and pulse

width, RV

Amplitude and pulse

width, RA

Refractory periods,

RA, RV

Refractory periods,

Pacing polarity,

CRTP

Pacing polarity, RA,

Pacing polarity, RV

Sensing polarity, RA,

Sensing polarity, RV

Sensitivity, RA

Sensitivity, RV

The ALIZEA models are covered by the following US patents:

US 5 167 224, US 5 226 415, US 5 249 572, US 5 271 394, US 5 303 702, US 5 312 451,

US 5 318 594, US 5 411 533, US 5 522 860, US 5 622 428, US 5 645 574, US 5 645 576,

US 5 674 265, US 5 702 424, US 5 702 426, US 5 713 928, US 5 722 996, US 5 741 315,

US 5 891 184, US 5 899 931, US 5 931 856, US 5 954 660, US 6 052 616, US 6 230 058,

US 6 307 261, US 6 336 048, US 6 337 996, US 6 397 105, US 6 408 209, US 6 487 451, US

6 487 452, US 6 505 068, US 6 532 238, US 6 574 507, US 6 711 441, US 6 773 404, US 6

778 859, US 6 830 548, US 6 890 306, US 6 898 845, US 6 912 421, US 6 975 905, US 7

020 515, US 7 072 716, US 7 164 946, US 7 076 297, US 7 142 924, US 7 395 115, US 7

440 795, US 7 440 801, US 7 630 770, US 7 797 045, US 8 043 225, US 7 856 705, US 8

583 255, US 8 554 318.

24. EXPLANATION OF SYMBOLS

ALIZEA – UA10414A 79