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

Events Possible adverse effects

Others Venous trauma (e.g., perforation, dissection,

erosion, rupture)

Tissue necrosis

Device related

Casing migration Pain, discomfort

Component failure Complications and mortality due to inability to

deliver appropriate and intended therapy, surgi-

cal intervention to remove/replace the device

Myopotential sensing Oversensing

Sensing circuit inhibition, reversion to backup

mode, or other failures due to electromagnetic

interference

Inappropriate functioning

Early battery depletion Complications and mortality due to inability to

deliver appropriate and intended therapy, surgi-

cal intervention to remove/replace the device

Leads related

Arrhythmia at implantation Extrasystoles, tachycardia, ventricular/atrial fib-

rillation

Cardiac perforation Intermittent or continuous loss of pacing and/or

sensing

Muscle or phrenic stimulation

Cardiac tamponade, fluid accumulation

Contamination, inflammation Pocket infection, endocarditis, septicaemia

may become necessary to perform surgical in-

tervention, to remove the device and/or the

lead

Lead displacement, migration, conductor frac-

ture or incorrect lead implantation

Intermittent or continuous loss of pacing and/or

sensing

Lead insulation rupture or abrasion Pectoral and other muscular stimulation, sud-

den fall in impedance, loss of efficacy of pac-

ing, early battery depletion

Lead tip perforation and/or breakage by over-

torquing

Intermittent or continuous loss of pacing and/or

sensing

Myocardial trauma Chest pain, cardiac wall perforation, arrhyth-

mias, formation of clot at injury site, bleeding,

embolism, pericardial effusion or rub, endo-

carditis

Threshold elevation Loss of capture

Phrenic elevation Pain, discomfort

Others Heart block

Valvular damage (particularly in fragile hearts)

Tachyarrhythmias, which include acceleration

of arrhythmias (caused by the device) and ear-

ly, recurrent atrial fibrillation

General

Others Death

Electrolyte imbalance/dehydration

Pain, inaesthetic scar

Vasovagal syncope

3. CONTRAINDICATIONS AND ADVERSE EVENTS

14 ALIZEA – UA10414A