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

Negative markers: ventricular events

Vr marker

Small marker

Ventricular sensing during a relative refractory period

Vs marker

Intermediate marker

Ventricular sensing outside the refractory periods

Vp marker

Large marker

Ventricular pacing (including pacing initiated in the SST mode)

Vn marker

Large marker

Ventricular pacing inside absolute refractory periods

The pacemaker starts transmitting markers when commanded by the programmer (see

programmer manual). Transmission is ended when the programmer head is removed, a

magnet is applied, or any key of the programmer is pressed.

Intracardiac ECG

The pacemaker provides noninvasive atrial and ventricular intracardiac ECGs, as well as,

atrial + ventricular intracardiac ECGs, which are essential to evaluate the pacing system.

The intracardiac ECG can be used to select pacing and sensing polarities, to reveal possible

myopotentials that are not visible on the surface ECG or to measure the retrograde

conduction time. The pacemaker stops transmitting intracardiac ECGs when the programmer

head is removed, a magnet is applied, or any key of the programmer is pressed.

NOTE:

The programmed sensed polarity determines the intracardiac ECG polarity displayed on the

programmer screen.

TEMPORARY PROGRAMMING

Temporary programming parameters:

― Mode

― Basic rate

― Maximum rate

― Sensing and pacing polarities

― Atrial and/or ventricular sensitivity

― Atrial and/or ventricular amplitude and pulse width

― Rest and exercise AV delays for DR model only

― AVD Paced/Sensed Offset for DR model only

Temporary parameters can be batch programmed. When temporary programming is used,

rate hysteresis is fixed to 0 % and rate response and smoothing are permanently disabled.

MEMORY FUNCTIONS

Memory functions are useful for assessing the performance of the pacemaker during the

patient’s daily life. They can be used in conjunction with the statistics function. The large

memory capacity of the pacemaker allows the beat-to-beat monitoring of many events for a

long period of time. Types of events and periods of time are listed in the descriptions that

follow.

18.7.2.

18.8.

18.9.

18. MEDICAL FOLLOW-UP

62 ALIZEA – UA10414A