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

8.7 years Cenelec conditions and DDD mode, assuming 100% pacing

70 min

-1

, 2.5 V, 0.5 ms, 500 Ω, Holter ON, sensors ON, Remote OFF

11.1 years ISO14708-2 conditions and DDD mode, assuming 100% pacing

60 min

-1

, 2.5 V, 0.35 ms, 600 Ω, Holter ON, sensors ON, Remote OFF

12.7 years Shipment conditions and SafeR mode, assuming 5% V pacing & 50% A pacing

60 min

-1

, 3.5 V, 0.35 ms, 500 Ω, Holter ON, sensors ON, Remote OFF

12.8 years SafeR mode, assuming 50% A pacing and 5% V pacing

60 min

-1

, 2.5 V , 0.35 ms, 750 ohms, sensors ON, Holter ON, Remote ON

13.0 years Cenelec conditions and SafeR mode, assuming 5% V pacing & 50% A pacing

70 min

-1

, 2.5 V, 0.5 ms, 500 Ω, Holter ON, sensors ON, Remote OFF

For the SR model:

The longevities are calculated by taking into account 6 months storage.

Longevity projection with VVI mode at 60 min

-1

, 2.50 V, 0.35 ms, Holter ON, Remote OFF

% V pacing Impedance (Ω) Sensors Longevity (years)

50 750 OFF 17.0

50 750 ON 15.4

50 500 OFF 16.2

50 500 ON 14.8

100 750 OFF 15.4

100 750 ON 14.1

100 500 OFF 14.3

100 500 ON 13.1

10.3 years Shipment conditions and VVI mode, assuming 100% pacing

70 min

-1

, 3.5 V, 0.35 ms, 500 Ω, Holter ON, sensors ON, Remote OFF

11.6 years Cenelec conditions and VVI mode, assuming 100% pacing

70 min

-1

, 2.5 V, 0.5 ms, 500 Ω, Holter ON, sensors ON, Remote OFF

13.6 years ISO14708-2 conditions and VVI mode, assuming 100% pacing

60 min

-1

, 2.5 V, 0.35 ms, 600 Ω, Holter ON, sensors ON, Remote OFF

An excessive number of remote follow-ups can have a non-negligible impact on device

longevity.

RADIO EQUIPMENT EMISSION

Radio Equipment Transmitter Frequency Bands

Maximal Power

Receiver Frequency

Bands

Inductive Teleme-

try

Slow mode: 8kHz, Fast mode: 16kHz

Simulated Worst Case (16kHz) in continuous

communication, -10.31 dBµA/m max at 10m

Slow mode: Frequency

~30kHz modulation

pulsed,

Fast mode: Frequency

~70 kHz modulation

pulsed.

Bluetooth Low En-

ergy™ ® RF

telemetry

(ISM Band)

Bluetooth Low Energy 4.2

2400-2483.5 MHz

-17.9 dBm max

Bluetooth Low Energy

4.2

2400-2483.5 MHz

20.5.

20. ELECTRICAL CHARACTERISTICS

68 ALIZEA – UA10414A