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

RATE TEST MODE:

The purpose of this mode is to measure the programmed amplitude and rate and, in dual

chamber pacing, the programmed AV delay.

During the rate test, the pacemaker operates as follows:

Mode

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

only)

VOO (if mode programmed: Vxx)

AOO (if mode programmed: Axx)

Rate Basic rate

Pulse amplitude and width As programmed

AV delay (for the DR model

only)

94ms

NOTES:

― If the magnet is reapplied during the capture test or the rate test, the pacemaker reverts

to the magnet test.

― The programmer is not effective during either magnet, capture, or rate test.

― For the DR model only: AVD Paced/Sensed Offset is not applied

THRESHOLD TESTS

Non-invasive threshold measurements can be performed in both chambers through the

pacemaker. Intracardiac ECG and markers are automatically transmitted for the paced

chamber during the threshold test.

Ventricular threshold test

The ventricular threshold test can be used when the pacemaker is programmed to

― VOO, VVI and VVT mode for the SR model

― VOO, VVI, VVT, DOO, DDI, DDD, Dplus and SafeR mode for the DR model

The test begins at user demand in the programmed mode, at the programmed start amplitude

(in volts) with the programmed number of spike(s) per amplitude. During the test, ventricular

pacing (and atrial if programmed for DR model) is (are) asynchronous. The pacing rate, the

pulse width and the polarity are respectively the programmed threshold rate, programmed

threshold pulse width and programmed threshold polarity.

The ventricular amplitude (in volts) sequence is 6V, 5V, 4.5V, 4V, 3.5V, 3V, 2.75V and then

decreases by steps of 0.25 V.

For the DR model, the AV delay is fixed to 95ms. If a magnet is applied, if the programming

head is removed, or if any key of the programmer is pressed, the test is immediately stopped.

Atrial threshold test

The atrial threshold test can be used when the pacemaker is programmed to

― AOO, AAI and AAT mode for the SR model

― AOO, AAI, AAT, DOO, DDI, DDD, Dplus and SafeR mode for the DR model

18.3.

18.4.

18.4.1.

18.4.2.

18. MEDICAL FOLLOW-UP

60 ALIZEA – UA10414A