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

3. CONTRAINDICATIONS AND ADVERSE EVENTS

GENERAL CONSIDERATIONS

For the DR model, the use of dual chamber pacing mode is contraindicated in patients with

chronic atrial fibrillation. In general, the patient's medical and physical condition, as well as

age, should always be taken into consideration when choosing the pacemaker and leads.

Furthermore, the benefits of pacing to pediatric subjects have not been evaluated. Adverse

interactions may occur between the patient's spontaneous rate and pacemaker functions.

ADVERSE EVENTS, RISKS AND SIDE EFFECTS

Based on the literature and on pulse generator and/or lead implant experience, the following

list includes the possible adverse events associated with implantation of pacing systems:

Events Possible adverse effects

Procedure related

Clotting disorder Pocket hematoma, bleeding, formation of clots,

may necessitate reintervention

Contamination, inflammation Pocket infection, endocarditis, septicaemia,

may become necessary to perform surgical in-

tervention, to remove the device and/or the

lead

Fibrotic tissue formation Pain, risk of hematoma and infection at the

time of replacement

Introduction of air (with subclavian approach) Air embolism

Poor lead/pacemaker connection Intermittent or continuous loss of pacing and/or

sensing

Others Adverse reaction to the procedure

Pneumothorax linked to subclavian access

Thrombosis

Thrombic embolism

Venous occlusion

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

erosion, rupture)

Tissue necrosis

Pocket related

Clotting disorder Pocket hematoma, bleeding, formation of clots,

may necessitate re-intervention

Contamination, inflammation Pocket infection, endocarditis, septicaemia

may become necessary to perform surgical in-

tervention, to remove the device and/or the

lead

Fibrotic tissue formation Risk of hematoma and infection at the time of

replacement

Skin erosion by the pacemaker with possible

protrusion/extrusion of the casing

Generally linked to infection and/or hematoma,

necessitates reintervention and to change the

site of implantation

3.1.

3.2.

3. CONTRAINDICATIONS AND ADVERSE EVENTS

ALIZEA – UA10414A 13