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

THERAPEUTIC IMPROVEMENTS

Features DR model SR model

SafeR x

Dplus x

Rate acceleration x

Rest rate x x

Smoothing x x

Mode switching x

SafeR mode

The SafeR mode is intended to minimize unnecessary ventricular pacing and to promote

spontaneous atrioventricular conduction. It gives priority to pacemaker operation in AAI(R)

mode: the sensed P wave does not trigger the AV delay and recycles an atrial escape

interval.

Indication:

SafeR is designed for patients requiring AAI(R) pacing (sinus node dysfunction) and/or who

are at risk for AV conduction disorders (paroxysmal AV block, permanent first degree AV

block, or exercise-induced AV block).

Operation:

The pacemaker functions in AAI(R) mode and temporarily converts to DDD(R) mode in the

following cases:

― AVB III: Two consecutive atrial events (paced or sensed) occur without subsequent

ventricular beats.

― AVB II: Three atrial events in twelve consecutive atrial cycles without subsequent

ventricular beats.

― AVB I: Six consecutive atrial events occur without subsequent ventricular beats within

a programmed PR interval (Long PR min and Long PR max parameters). This AVB I

criterion can be activated continuously or only during exercise phase depending on the

AVB I switch parameter.

― PAUSE: No ventricular beat occurs within a programmed interval (Max pause parameter,

programmable to 2, 3 or 4 seconds).

The device regularly switches back to AAI(R) mode (at least once a day):

― after sensing 12 consecutive spontaneous ventricular events

― automatically every 100 paced ventricular cycles.

After an automatic switch to AAI(R) mode, if the intrinsic AV conduction has not resumed,

the device switches back to DDD(R) mode according to the criteria listed above (third degree

AVB, second degree AVB, first degree AVB or the pause).

The SafeR-R mode is a SafeR mode with Rate Response.

The SafeR/DDIR mode activates a switch from SafeR to DDIR mode when the pacemaker

enters Fallback Mode Switching. Rate responsive pacing is only functional when the patient

is in Fallback Mode Switching. The physical activity used during the Fallback Mode Switching

phase is equal to the programmed parameter.

15.6.

15.6.1.

15. FUNCTIONS AND PARAMETERS

ALIZEA – UA10414A 43