User Manual
Table Of Contents
- 1. General description
- 2. Indications
- 3. Contraindications
- 4. Warnings and precautions
- 5. Adverse events
- 6. Clinical studies
- 7. Patient selection and treatment
- 8. Patient counselling information
- 9. Conformance to standards
- 10. Physician guidelines
- 11. Patient information
- 12. How supplied
- 13. Device description
- 14. Implant procedure
- 14.1. Necessary equipment
- 14.2. Packaging
- 14.3. Optional equipment
- 14.4. Before opening the package
- 14.5. Prior to implantation
- 14.6. Device placement
- 14.7. Choosing the type of lead
- 14.8. Shock configuration (+ -> -)
- 14.9. Measurement of thresholds at implant
- 14.10. Leads connection
- 14.11. Device implantation
- 14.12. Tests and programming
- 15. Special modes
- 16. Main functions
- 17. Patient follow-up
- 18. Supplemental Information
- 19. Physical characteristics
- 20. Electrical characteristics
- 21. Programmable parameters
- 22. Non programmable parameters
- 23. Limited warranty
- 24. Patents
- 25. Explanation of symbols
16. MAIN FUNCTIONS
16.8.3 . Data transmitted
The data transmitted are identical to the data available during a standard interrogation with
the dedicated programmer. All counters, histograms, IEGMs and diagnosis available in the
device are transmitted containing (not exhaustive list):
─ programmed parameters
─ Information on patient and system implanted
─ battery status
─ lead status (brady leads and defibrillation coils)
─ pacing counters and mean heart rate (brady)
─ atrial and ventricular arrhythmia counters and episodes
─ ventricular therapy counters
Data are presented in the form of 2 reports to the physician: the first one contains a
summary of major counters, histograms, warnings and diagnosis. The second one presents
the 3 most important IEGM episodes automatically selected based on the degree of severity
for the patient.
16.8.4 . User website
On the website, the physician is able to:
─ consult and schedule the remote follow-ups of their patient
─ configure additional ways of being notified of alerts (for instance by SMS, fax or e-mail
─ consult, print and export patient reports
16.8.5 . Alert system
The following set of alert trigger can be independently programmed ON/OFF by the
physician using the dedicated programmer and can trigger an alert transmission:
─ Low or high impedance (A, RV, LV)
─ Abnormal coil impedance (shock lead)
─ Low or High shock impedance
─ Inefficient high energy shock
─ All shocks programmed OFF
─ Shock treated VT/VF
─ Lack of V pacing in CRT device
─ Suspicion of noise on the V lead
─ AT/AF occurrence
─ Fast V rate during AT/AF
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SORIN – INTENSIA SonR CRT-D 184 – U150A
WARNING: The use of remote monitoring does not replace regular follow-up. Therefore,
when using remote monitoring, the time period between follow-ups visits may not be
extended.