User's Manual

SOCR System User Guide Page 6 of 27
Revision B April 2013 Medtronic Confidential
2. SYSTEM OVERVIEW
2.1 SYSTEM DESCRIPTION
The SOCR System (Figure 1) contains electronics that control the continuous
stimulation and sensing required to collect real-time intracardiac impedance
and heart sounds signals. The impedance signals are collected from selected
electrode vector configurations using the subject’s implanted pacing leads/LV
catheter and an investigational impedance pacing unit, the Model 19061
Acute Human Monitor (AHM) Module. A Model 2090 programmer with the
SOCR Investigational Software along with a switch on the front panel of the
AHM Module allow the user to select specific electrode vector configurations
for current stimulation and voltage sense measurement. The heart sounds
signals are collected from an investigational Model 19062 Heart Sound
Sensor Device placed on the subject.
Real-time impedance and auxiliary signals from analog output terminals of the
AHM Module, real-time heart sounds and EGM/marker signals from the two
programmers through a 2090A/B Analog Output Module, and real-time LV
pressure signals from the Millar PCU-2000 are transmitted to the applicable
Biopac Data Acquisition System’s analog input terminals. The Biopac Data
Acquisition System transmits the acquired analog input signals to the
computer’s data acquisition software [AcqKnowledge
®
] which subsequently
saves the data to the computer’s hard disk and displays real time waveform
data on the computer’s display.
The AHM Module also contains circuitry for standard pacing interventions with
the implanted right atrial (RA) lead, right ventricular (RV) pacing lead, and left
ventricular (LV) pacing lead or catheter. The leads are connected to an
investigational Model 15420 Patient Cable in order to interface with the AHM
Module. The LV catheter is directly connected.
The Biopac MP150 Data Acquisition System also collects physiologic signals
from standard EP laboratory equipment used for subject monitoring during
device implant. These physiologic signals may include ECG, blood pressure,
or other physiologic signals. Available physiologic signals can be recorded
simultaneously with the above signals but are not required by Medtronic to
obtain the study objectives.
The SOCR system is shown pictorially in Figure 1.
Approval date:
4.0
DSN009462
22-Apr-2013 16:05 UTC
Rev.