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

All explanted pacemakers should be returned to your MicroPort representative carefully

cleaned of all traces of contamination. Cleaning can be achieved by immersing the

pacemaker in an aqueous sodium hypochlorite containing at least 1% chlorine, followed by

rinsing copiously with water.

The pacemaker should be packaged so as to protect against the mechanical impact and

temperature variations that may occur during shipping.

PROGRAMMER TESTS

The MicroPort dedicated programmer is designed to:

― perform impedance tests on the lead for the SR model and on both atrial and ventricular

leads for the DR model,

― perform pacing threshold tests on the paced cavity(ies) in asynchronous mode, in the

ventricle this test can be performed manually or automatically,

― determine the amplitude of sensed waves for the SR model and atrial and ventricular

waves for the DR model,

― display the patient's ECG with temporarily modified programming parameters (e.g., to

observe the patient's subjacent rhythm),

― perform electrophysiologic studies (bursts and extrastimulus sequences).

INTERROGATING THE DIAGNOSTIC DATA (AIDA)

Interrogating the diagnostic data provides:

― statistics since the last follow-up,

― 6-month curves and histograms for evaluating device operation if AIDA programmed on

6 months,

― recorded episodes (fallback mode switching for the DR model, atrial and/or ventricular

bursts, switches from AAI to DDD for the DR model, atrial and/or ventricular

autothreshold episodes) including intracardiac ECGs and continuous heart rate recording

over the last 7 days,

― diagnostic messages about events detected by the device.

SafeR (Preservation of AV conduction)

The following AV conduction graphs are presented:

1. Monitoring of the evolution of patient’s AV conduction

2. Overview of all switches due to various types of AV blocks, classified by day/night and by

exercise/rest.

3. Histograms showing the day to day distribution of blocked atrial events and the number

of pacemaker switches from AAI to DDD(R)

4. EGM strips associated to AV block switches and pauses.

PACEMAKER IDENTIFICATION

The pacemaker can be interrogated and programmed via telemetry, using the programming

head interfaced with the MicroPort dedicated programmer.

The device can be non-invasively identified as follows:

16.4.

16.5.

16.5.1.

16.6.

16. PATIENT FOLLOW-UP

56 ALIZEA – UA10414A