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

14. SPECIAL MODES

NOMINAL MODE (SAFETY MODE)

Safety settings may be rapidly restored by pressing the Emergency button below: via the

MicroPort dedicated programmer screen, the programming head or the MicroPort dedicated

programmer keyboard.

In nominal mode, the pacemaker operates with the parameters from the table of

programmable parameters.

STANDBY MODE

In the event of self-test failure, the pacemaker switches automatically to a safe mode of

operation known as standby mode. In most cases, normal pacemaker operation may be

re-established (if the pacemaker is at a stabilized temperature of approximately 37°C) by

confirming the reinitialization function suggested by the MicroPort dedicated programmer. If

this is not the case, contact your MicroPort representative.

In standby mode, the pacemaker operates with the following parameters: VVI, 70 ppm, 5 V,

0.5 ms, sensitivity 2.2 mV, unipolar for the DR model and the SR model when implanted in

the ventricle or AAI for the SR model when implanted in the atrium.

Programming is then impossible and test modes, including magnet mode, are ineffective.

MAGNET MODE

When a magnet is applied, the pacemaker terminates the cycle in progress and operates

using the following parameters:

Mode

DOO (if mode programmed: Dxx or SafeR for the DR model only)

VOO (if mode programmed: Vxx)

AOO (if mode programmed: Axx)

Rate Magnet rate

Pulse amplitude 5 V (or greater if the programmed amplitude value is greater)

Pulse width 0.5 ms (or greater if the programmed pulse width value is greater)

AV delay (for the DR

model only)

Rest AV delay

On exiting magnet mode, the device operates:

― for 6 cycles by pacing at the magnet rate, with an AV delay of 95 ms (if applicable and for

the DR model only), with the programmed amplitude and pulse width in asynchronous

mode,

― then for 2 cycles with the programmed parameters in asynchronous mode.

RESPONSE IN THE PRESENCE OF INTERFERENCE

If the pacemaker senses electrical noise at a frequency above 20 Hz, it switches to an

asynchronous mode at the basic rate. The programmed mode is restored as soon as the

14.1.

14.2.

14.3.

14.4.

14. SPECIAL MODES

ALIZEA – UA10414A 35