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

16. PATIENT FOLLOW-UP

RECOMMENDED REPLACEMENT TIME (RRT)

The Recommended Replacement Time (RRT), previously known as Elective Replacement

Indicator (ERI) is controlled by:

― a battery voltage:

― of 2.63 V if Remote monitoring activated;

― of 2.70 V if Remote monitoring deactivated.

When RRT is reached, a magnet rate of 80 ± 1 ppm is applied by the device. As the EOS

(End Of Service) approaches, the magnet rate decreases to 70 ± 1 ppm.

CAUTION:

The pacemaker should be replaced as soon as the Recommended Replacement Time (RRT

or ERI) point is reached.

When the RRT (or ERI) point is reached, the following parameters are switched to the settings

specified below until the end of the device's service:

― Mode: VVI

― Basic rate: 70 ppm

― Rate hysteresis : off

― Rate response mode: off

― Smoothing: off

Other parameters remain as programmed.

If activated, the remote monitoring function is deactivated after RRT once the RRT alerts have

been sent.

After having reached the RRT (or ERI), the Prolonged Service Period (PSP) of the device is:

― at least 3 months under the following conditions: VVI, 70 ppm, 5V, 0.35ms, 500 Ω, 100%

pacing (Nominal parameters).

― at least 6 months under the following conditions: VVI, 60 ppm, 2.5V, 0.35ms, 600 Ω,

100% pacing according to ISO14708 section 19.2.

Time to RRT (residual longevity): estimated remaining service time of the device. This

estimate is calculated using battery voltage, leads measurements, statistics and programmed

parameters. This value is refreshed automatically after each programming impacting device

longevity.

FOLLOW-UP RECOMMENDATIONS

Standard follow-up

Annual standard follow up is recommended. Before the patient’s discharge, and at each

follow-up visit, it is advisable to:

1. Check the battery status.

16.1.

16.2.

16. PATIENT FOLLOW-UP

54 ALIZEA – UA10414A