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

CORRESPONDENCE BETWEEN MAGNET RATE AND BATTERY LIFE

Table of magnet rate:

Battery life BOS RRT EOS

Magnet Rate (bpm) 96 80 70

BATTERY

Manufacturer LITRONIK GmbH

Type Lithium manganese dioxide (LiMnO2)

Model LiS 3150 MP

Total capacity 1.2 Ah

Usable capacity

Without Remote monitoring, between BOS and RRT = 1.123 Ah,

between RRT et EOS = 0.053 Ah.

With Remote monitoring, between BOS and RRT = 1.040 Ah, be-

tween RRT and EOS = 0.136 Ah.

Voltage

BOS: 3.20 V without Remote monitoring

BOS: 3.10 V with Remote monitoring

RRT: 2.70 V without Remote monitoring

RRT: 2.63 V with Remote monitoring

EOS: 2.50 V

LONGEVITY

For the DR model:

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

Longevity projection at 60 min

-1

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

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

SafeR 50 5 750 OFF 16.2

SafeR 50 5 750 ON 14.7

SafeR 50 5 500 OFF 15.5

SafeR 50 5 500 ON 14.1

DDD 100 100 750 OFF 12.7

DDD 100 100 750 ON 11.8

DDD 100 100 500 OFF 11.2

DDD 100 100 500 ON 10.5

20.2.

20.3.

20.4.

20. ELECTRICAL CHARACTERISTICS

ALIZEA – UA10414A 67