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

12. IMPLANT PROCEDURE

NECESSARY EQUIPMENT

Implantation of ALIZEA DR / SR requires the following equipment:

― MicroPort dedicated programmer, equipped with the SMARTVIEW software interface

and inductive telemetry head,

― pacing system analyzer, as well as its sterile connecting cables, to evaluate the pacing

and sensing thresholds,

― a complete set of leads with corresponding introducers,

― physiological signal monitor capable of displaying simultaneously the surface ECG and

arterial pressure,

― an external defibrillator with sterile external paddles,

― sterile cover for the telemetry head.

PACKAGING CONTENTS

ALIZEA DR / SR and its accessories are ethylene oxide sterilized and hermetically sealed in

two-ply clear packaging meeting international requirements.

The sterile packaging contains:

― the pacemaker,

― a ratcheting screwdriver.

As delivered, ALIZEA DR / SR is programmed to as-shipped values that are different from

nominal values (see “Programmable Parameters” section for details).

OPTIONAL EQUIPMENT

The following equipment may be required during implantation of ALIZEA DR / SR:

― an IS-1 insulating plug to close the atrial port (only for ALIZEA DR),

― sterile water to clean traces of blood. Any parts cleaned with sterile water must be

thoroughly dried,

― mineral oil to lubricate if necessary,

― a lead cap to isolate a lead which is not used.

OPENING THE PACKAGE

Before opening the package:

― Check the "Use by" date printed on the labels on the box and on the sterile package.

Pacemakers not implanted before the “Use by” date should be returned to your MicroPort

representative.

― Interrogate the device before activating the remote monitoring: if a warning is displayed

or if battery voltage is too low (< 3.04V), do not implant the device and contact your

MicroPort representative.

12.1.

12.2.

12.3.

12.4.

12. IMPLANT PROCEDURE

30 ALIZEA – UA10414A