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

2. Check for proper sensing (sensitivity for the both SR and DR models, crosstalk

for the DR model) and pacing; set the pacing amplitude to twice the pacing threshold.

3. Interrogate the device memories (AIDA)

4. Keep a printout of programmed parameters, test results, and memory data.

Frequent follow-up

When the minimum estimated residual longevity displayed by the MicroPort dedicated

programmer is less than or equal to 12 months:

― It is recommended to conduct patient follow-up visit at an interval that is between

the minimal and the typical residual longevities displayed by the MicroPort dedicated

programmer, without exceeding 12 months (i.e. the annual standard follow-up).

― For pacemaker-dependent patients, it is recommended to conduct patient follow-up

visit at an interval equal to the minimal residual longevity displayed by the MicroPort

dedicated programmer.

NOTES:

“Time to RRT = N/A” is displayed by the MicroPort dedicated programmer

― If less than 5 minutes statistics are available (i.e. first interrogation at implant, device

reset),

― If any lead impedance related to each currently pacing chamber does not have a valid

value (range between 200 and 3000 Ω).

If “Time to RRT” is still N/A (outside of the two cases listed here above), contact your

MicroPort Representative.

Replacement

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

point is reached.

Implant software upgrade

In case new implant software is downloaded in the device memory through the MicroPort

dedicated programmer, a warning message may be displayed by the MicroPort dedicated

programmer to inform the user and give the proper instructions to follow.

EXPLANTATION

The pacemaker should be explanted in the following cases:

― End of service;

― Confirmed malfunction;

― Cremation of the patient (the pacemaker may explode if placed in an incinerator);

― Patient death: for environmental reasons, the local regulation may require the

explantation of the devices containing a battery supply.

WARNING:

The pacemaker is a single use impantable device. The explanted pacemaker should not be

reused in another patient. It could lead to inflammation, intoxication or infection of the patient.

16.3.

16. PATIENT FOLLOW-UP

ALIZEA – UA10414A 55