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

The test begins at user demand in the programmed mode, at the programmed start amplitude

(in volts) with the programmed number of spike(s) per amplitude. During the test, atrial pacing

(and ventricular if programmed for DR model) is (are) asynchronous. The pacing rate, the

pulse width and the polarity are respectively the programmed threshold rate, programmed

threshold pulse width and programmed threshold polarity.

The atrial amplitude (in volts) sequence is 6V, 5V, 4.5V, 4V, 3.5V, 3V, 2.75V and then

decreases by steps of 0.25 V.

For the DR model, the AV delay is fixed to 250ms. If a magnet is applied, if the programming

head is removed, or if any key of the programmer is pressed, the test is immediately stopped.

LEAD MEASUREMENTS

The lead measurement test mode allows non-invasive measurements of atrial and/or

ventricular lead characteristics. The lead measurement test mode begins when programmed

and lasts one cycle.

The pacing rate is programmable (80, 90, 100, 110, 120 ppm) and the pulse width is greater

than or equal to 0.5 ms in the paced chamber(s).

The programmer displays the measured averages for voltage current and impedance.

MEASURABLE RANGE

Parameters Min. Max.

Voltage (V) 1.4 7.5

Current (mA) 0.5 28.0

Impedance (kΩ) 0.2 3.0

STATISTICS

The pacemaker automatically stores data via diagnostic counters that can be reset at any

time. These counters can be used to check the function of the pacemaker, to optimize

programmable values and to evaluate the need for special features.

MARKERS AND INTRACARDIAC ECG

The atrial or ventricular EGM and the markers can be obtained simultaneously on the

programmer screen.

Markers

Event markers are particularly useful in the interpretation of dual chamber pacemaker ECGs.

Positive markers: atrial events

Ar marker

Small marker

Atrial sensing during a relative refractory period and in DDI mode

As marker

Intermediate marker

Atrial sensing outside the refractory periods

Ap marker

Large marker

Atrial pacing (including pacing initiated in the SST mode)

An marker

Large marker

Atrial pacing inside absolute refractory periods

18.5.

18.6.

18.7.

18.7.1.

18. MEDICAL FOLLOW-UP

ALIZEA – UA10414A 61