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

Automatic detection of implantation

Operation:

At implantation, once the ventricular lead has been connected to the pacemaker and the

case is in contact with the tissue, the device starts the detection of implantation. After five

minutes, the device automatically checks if the ventricular lead is still connected to the

pacemaker and the case still in contact with the tissue:

1. If yes, the detection of implantation is automatically confirmed.

2. If no, a new check is done by the device every five minutes, until the ventricular lead

connection and the contact between the pacemaker and the tissue are confirmed.

The automatic detection of implantation can be deactivated via the programmer. In such case

none of the automatic configuration steps described below will be done automatically; they

shall be done manually as appropriate.

Measurements of lead impedances:

Twenty minutes after the detection of implantation has been confirmed, the device starts

measuring the lead impedance(s) every 6 (six) hours and data is stored for each chamber.

Automatic launch of parameters:

Twenty minutes after the detection of implantation:

1. Memories are initiated.

2. Sensor is programmed to "Learn".

3. Statistics are reset to zero.

4. Remote monitoring is activated if programmed

5. Ventricular Autothreshold is activated if programmed

6. For the DR model, Atrial Autothreshold is activated if programmed

7. Lead polarity Switch is activated if programmed

8. For the DR model, the device switches from DDD to SafeR mode if programmed.

Autosensing

The Autosensing function allows automatic adjustment of the sensitivity for the SR model

and for both atrial and ventricular sensitivities for the DR model.

Operation:

1. If the ventricular (or atrial) Autosensing function is programmed to Auto, the ventricular

(or atrial) sensitivity is constantly adjusted to 37.5% of the mean amplitude of the

ventricular (or atrial) signals.

2. When the atrium is paced, the sensitivity tends toward 0.4 mV. For the DR model, for

the duration of an atrial arrhythmia, the atrial sensitivity tends toward 0.4 mV.

3. When the ventricle is paced, the ventricular sensitivity tends toward 1.5 mV in bipolar

configuration and toward 2.5 mV in unipolar configuration.

Programming constraints:

1. The atrial Autosensing function (Auto mode) is available only when the atrial sensing

polarity is bipolar.

15.7.1.

15.7.2.

15. FUNCTIONS AND PARAMETERS

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