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
LV MULTIPOINT PACING (MP)
PLATINIUM 4LV CRT-D 1744 features simultaneous multipoint left ventricular pacing allowing
LV pacing on 2 differents vectors at the same time, named MP1 and MP2 LV pacing sites.
FOLLOW-UP FUNCTION
Storage of memory data:
AIDA (Automatic Interpretation for Diagnosis Assistance) software provides access up to 6
months of patient follow-up with day by day data collection, or up to 24 hours with hourly data
collection. Episodes of ventricular tachyarrhythmia are recorded with one programmable
EGM channel which can be selected, in addition to RV EGM.
Alerts / Warnings:
The device routinely performs security self-checks and technical measurements to ensure
system integrity. When system integrity is found to be at risk outside a follow-up, alerts are
stored in the device memory. When system integrity is found to be at risk during a follow-
up, the information is managed by a warning (pop-up message) to immediately notify the
user. For example, the following types of events can trigger a warning or an alert: technical
problem during a shock, lead impedance or shock continuity measurements out-of-range,
battery depletion, …
REMOTE MONITORING FUNCTION
Remote monitoring enables the automatic remote transmission of implant data to the
physician thanks to the wireless Radio Frequency (RF) communication ability of the implant in
order to provide a comprehensive report to the physician about device functioning and patient
cardiac status without having the patient physically in the clinic.
The data is transmitted from the implant to the SMARTVIEW monitor, a small transmitter
placed in the patient's home.
Implant data are first transmitted to the SMARTVIEW monitor via RF. Data are then routed
through the phone line or via GPRS to an internet website. This website is responsible for
transforming the implant data into a comprehensive report that can be consulted by the
physician.
SMARTVIEW Monitor
The SMARTVIEW monitor is a small device equipped with an RF transmission module to
communicate with the implant and a modem to export data through the internet.
The SMARTVIEW monitor is delivered to the patient who has to install it at home. Preferably
the SMARTVIEW monitor will be placed on the nightstand of the patient, as close as possible
to the side of the bed where the patient usually sleeps. The SMARTVIEW monitor connects
to the phone line of the patient and the power plug. Regular transmissions are done during
the night when the patient is asleep next to the SMARTVIEW monitor without any intervention
from the patient.
Transmission trigger
There are 3 different triggers for a remote transmission:
― the remote follow-up transmission is scheduled by the physician to occur regularly
(according to the programming).
16.6.
16.7.
16.8.
16.8.1.
16.8.2.
16. MAIN FUNCTIONS
SORIN – PLATINIUM 4LV CRT-D 1744 – U904A 43