User's 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. Declaration of conformity
- 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
16.7.3. 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 most important IEGM episodes automatically selected based on the degree of severity
for the patient.
16.7.4. 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
16.7.5. 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
─ ATP 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
The following set of alert trigger (system alerts) cannot be deactivated when the Alerts are
programmed “On” and can trigger an alert transmission:
─ Battery depletion – RRT
─ Device reset
─ Excessive charge time (>25s)
─ System integrity
SORIN – PLATINIUM CRT-D – U459A
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