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

8. DECLARATION OF CONFORMITY

MicroPort declares that this device is in conformity with the essential requirements of Radio

Equipment Directive 2014/53/EU, with the mutual recognition of their conformity (RED).

Federal Communication Commission Interference Statement 47 CFR Section 15.19 and

15.105(b)

The FCC product ID is :

― ALIZEA DR: YSG1614

― ALIZEA SR: YSG1311

ALIZEA pacemaker is featuring Bluetooth Low Energy communication capability. Using a

standard Bluetooth Low Energy component not initially intended for use in life support

applications, MicroPort CRM has fully qualified that Bluetooth Low Energy communication to

comply with implantable medical devices intended use and safety requirements.

This equipment has been tested and found to comply with the limits for a Class B digital

device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide

reasonable protection against harmful interference in a residential installation. This

equipment generates, uses and can radiate radio frequency energy and, if not installed

and used in accordance with the instructions, may cause harmful interference to radio

communications. However, there is no guarantee that interference will not occur in a

particular installation.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following

two conditions: (1) This device may not cause harmful interference, and (2) this device must

accept any interference received, including interference that may cause undesired operation.

FCC Interference Statement 47 CFR Section 15.21 - No Unauthorized Modifications

CAUTION:

This equipment may not be modified, altered, or changed in any way without signed written

permission from MicroPort. Unauthorized modification may void the equipment authorization

from the FCC and will void the MicroPort warranty.

Identification of the equipment according to Section 95.1217(a)

This transmitter is authorized by rule under the Medical Device Radiocommunication Service

(in part 95 of the FCC Rules) and must not cause harmful interference to stations operating

in the 400.150-406.00 MHz band in the Meteorological Aids (i.e., transmitters and receivers

used to communicate weather data), the Meteorological Satellite, or the Earth Exploration

Satellite Services and must accept interference that may be caused by such stations,

including interference that may cause undesired operation. This transmitter shall be used

only in accordance with the FCC Rules governing the Medical Device Radiocommunication

Service. Analog and digital voice communications are prohibited. Although this transmitter

has been approved by the Federal Communications Commission, there is no guarantee that

it will not receive interference or that any particular transmission from this transmitter will be

free from interference.

8. DECLARATION OF CONFORMITY

ALIZEA – UA10414A 23