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

CHOOSING THE TYPE OF LEAD

For the DR model, for optimal use of pacemaker functions, the atrial lead should be bipolar.

If a unipolar atrial lead is used, the Autosensing function will not be available. For MRI

compatibility, both leads should be bipolar.

For the SR model, for optimal use of pacemaker functions, the lead used should be bipolar. If

a unipolar lead is used, the following function will not be available: the rate-response function

based on minute ventilation. For MRI compatibility, the lead should be bipolar.

Use of a high polarization ventricular lead interferes with normal operation of the Ventricular

Autothreshold function.

Connections:

The pacing/sensing connectors are IS-1 compatible. Other lead configurations are not

compatible.

MEASUREMENT OF THRESHOLDS AT IMPLANT

Pacing and sensing thresholds should be measured at implant.

Pacing thresholds:

Acute thresholds should be lower than 1 V for a 0.5 ms pulse width, both in the ventricle and

in the atrium.

Chronic thresholds should be less than 3 V for a 0.5 ms pulse width.

Sensing thresholds:

For proper ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. For

proper atrial sensing, the amplitude of the P-wave should be greater than 2 mV.

LEAD CONNECTIONS

It is imperative that each lead be properly connected to the corresponding pacemaker

connector (the position of each connector is indicated on the casing).

CAUTION:

For the SR model, only one lead will be connected (ventricular or atrial). For the DR model,

two leads will be connected: ventricular and atrial.

For each lead, only distal inserts must be tightened. To connect each lead, proceed as

follows:

1. For the SR model, insert the ventricular or atrial lead pin all the way into the pacemaker

port.

For the DR model, insert the ventricular lead pin all the way into the appropriate

pacemaker port (marked V) of the pacemaker.

2. Insert the screwdriver in the centre of the prominent screwdriver slot contour on the distal

insert, then into the pre-inserted screw.

3. Tighten the screw until the screwdriver clicks. Check the fixation by pulling the lead (the

lead should remain in the pacemaker when pulling to check the tightness).

12.6.

12.7.

12.8.

12. IMPLANT PROCEDURE

32 ALIZEA – UA10414A