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

4. WARNINGS

PACEMAKER DEPENDENT PATIENTS

Electrograms of the patient’s intrinsic activity should be obtained with care since the patient

is without pacing support.

Automated threshold testing should be terminated, either by pressing any key or by

removing the programming head when capture ceases in order to restore the preprogrammed

pulse amplitude and ensure capture. Otherwise, the pacemaker will continue the threshold

test for the remainder of the test period without pacing the patient (i.e. without capture of the

heart).

WARNINGS TO PATIENTS

The patient should be warned of the potential risks of pacemaker malfunction if he/she is

exposed to external magnetic, electrical, or electromagnetic signals.

Electrical equipment:

Household electrical appliances do not affect the functioning of the pacemaker, providing they

are insulated according to current standards. However, patients should avoid using induction

ovens and cookers.

Electronic Article Surveillance (EAS) and RadioFrequency IDentification

equipment (RFID):

Patients should be advised to walk directly through and not lean against or linger near

Electronic Article Surveillance (EAS) systems such as retail theft prevention systems, security

gates, entry control systems, or tag readers including Radio Frequency IDentification

equipment (RFID). These systems may be found at the entrances and exits of stores,

libraries, banks, etc...and may interact with pulse generators. It is unlikely that these systems

affect cardiac function when the patient walks through them at a normal pace. If patients do

experience symptoms near these systems, they should promptly move away and inform their

doctor.

Work environment:

The patient's work environment may be an important source of interference; as a result,

specific recommendations may be required.

Cellular phones:

The devices are protected against high-frequency signals emitted by cellular telephones.

Nevertheless it is recommended not to keep the cellular telephone too close to the

pacemaker.

RISKS RELATED TO MEDICAL ENVIRONMENT

Pacemaker operation should be carefully monitored prior to and after any medical treatment

during which an electrical current from an external source passes through the patient's body.

4.1.

4.2.

4.3.

4. WARNINGS

16 ALIZEA – UA10414A