Medtronic 19061 User Manual
Rev.
4.0
DSN009462
Sensor Optimization of CRT
Response (SOCR) System
User Guide
Caution: Investigational device. Limited by federal law (USA) to investigational use.
Exclusively for clinical investigations.
Investigational Device / Instrument de recherche.
To Be Used by Qualified Investigators Only / Réservé uniquement à l'usage de
chercheurs compétents.
SOCR System User Guide Page 1 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
22-Apr-2013 16:05 UTC
Term
Definition
Rev.
4.0
SYMBOLS DEFINITIONS:
Attention, consult accompanying documents.
Device is type CF, direct cardiac applied parts.
Caution or Warning notice.
Do not reuse, single patient use only.
Conformité Européenne (European Conformity).
This symbol means that the device fully complies with R&TTE
Directive 1999/5/EC.
DSN009462
Do not dispose of this product in the unsorted municipal
waste stream. Dispose of the product according to local
regulations.
TERMINOLOGY DEFINITIONS:
Subject Patient under study.
Impedance Ratio of voltage measured divided by current injected.
Vector Pacing lead electrode configuration for impedance measurement.
SOCR System User Guide Page 2 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
22-Apr-2013 16:05 UTC
Rev.
4.0
Table of Contents
1. Physical Characteristics.................................................................................4
1.1 System Components..........................................................................4
1.2 Power Source...................................................................................... 4
1.3 Intended Use Environment................................................................5
2. System Overview...........................................................................................6
2.1 System Description............................................................................6
2.2 Intended Use.......................................................................................8
2.2.1 Intended Use of the Model 19061 AHM Module................................8
2.2.2 Intended Use of the Model 19062 Heart Sound Sensor Device........8
2.2.3 Intended Use of the Model 15420 Patient Cable...............................9
2.3 Cleaning and Maintenance ................................................................ 9
DSN009462
2.4 Warnings and Precautions ................................................................ 9
2.5 Potential Adverse Events ................................................................10
2.6 Contraindications.............................................................................10
3. System Setup ..............................................................................................11
3.1 Biopac System Overview.................................................................11
3.2 Connections to the Biopac System ................................................12
3.3 Connections to and Use of the AHM Module.................................13
3.4 Connections to the Subject.............................................................15
3.5 Installing and Uninstalling the SOCR Investigational Software...16
3.6 Starting the SOCR Investigational Software..................................16
3.7 Software Setup for the AHM Module...............................................17
3.7.1 Programming Impedance Vectors...................................................19
3.8 Software Setup for the Heart Sound Sensor Device .....................20
4. Setup Test Procedure..................................................................................21
Appendix A – Installing the SOCR Investigational Software...............................22
Appendix B – Uninstalling the SOCR Investigational Software...........................25
SOCR System User Guide Page 3 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
22-Apr-2013 16:05 UTC
Table 1.
System Components
Component
Description
Rev.
4.0
1. PHYSICAL CHARACTERISTICS
1.1 SYSTEM COMPONENTS
Components included as part of the SOCR research system are shown in Table
1.
DSN009462
Investigational Model 19061 AHM
Module
Investigational Model 19062 Heart
Sound Sensor Device
Biopac MP150 and UIM100C Data acquisition system
Model 2090 Programmer with
Viva/Brava Software with 2090 A/B
and cable
Model 2090 Programmer with SOCR
Investigational Software with 2090
A/B and cable
Laptop Computer with AcqKnowledge
Software package
Investigational Model 15420 Patient
Cable
RA/RV leads Connections to subject right heart
LV lead or LV catheter/patient cable Connections to subject left heart
Millar pressure catheter LV pressure component
Millar PCU-2000 and patient cable LV pressure measurement component
Impedance measurement and pacing component
Heart sounds component
Programmer for Heart Sound Sensor Device
Programmer for AHM Module
Used for data acquisition software
Used for connection of AHM Module to subject pacing
leads
1.2 POWER SOURCE
The AHM Module is powered by six 3.6V AA lithium batteries. A set of batteries
will provide at least 4-hours of procedure time before requiring replacement.
These batteries will be provided by Medtronic to centers for use in the study. The
Heart Sound Sensor Device has a self-contained battery. All other system
components requiring power (i.e. the laptop, Biopac MP150, and the 2090
Programmers) will use AC line power.
of 3.6V AA lithium batteries provided by Medtronic prior to each clinical case.
SOCR System User Guide Page 4 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
Caution: It is recommended that the AHM Module be fitted with a fresh set
22-Apr-2013 16:05 UTC
Rev.
4.0
Caution: It is recommended that the SOCR System be disconnected from
the subject during battery replacement.
Caution: The 2090 Programmer is powered with AC line power.
Caution: The Biopac MP150 Data Acquisition System is powered with AC
line power.
Caution: The laptop computer is powered with AC line power.
1.3 INTENDED USE ENVIRONMENT
The SOCR System is designed to operate in an Electrophysiology (EP) Lab or
hospital environment under the direct supervision of medical personnel. The
system was not tested to handle exposure to autoclave (except for the Model
15420 Patient Cable sterilization procedure), hyperbaric chambers, cold
temperatures, high temperatures, high humidity, steam, special gases
(anesthetic etc.), fluids, or other severe conditions.
DSN009462
Caution: The Model 19061 AHM complies with Part 15 of the FCC rules.
Operation is subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation. Changes or
modifications of any kind not expressly approved by Medtronic could void the
user’s authority to operate the equipment.
AHM FCC ID: LF519061
SOCR System User Guide Page 5 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
22-Apr-2013 16:05 UTC
Rev.
4.0
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.
DSN009462
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.
SOCR System User Guide Page 6 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
22-Apr-2013 16:05 UTC
Rev.
4.0
DSN009462
Figure 1. SOCR System Components.
Warning: The SOCR System is intended for investigational use only and
should be used only by trained Medtronic personnel, clinical study investigators
and designated clinical staff trained in performing the acute clinical study
protocol.
SOCR System User Guide Page 7 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
22-Apr-2013 16:05 UTC
Rev.
4.0
2.2 INTENDED USE
The SOCR System (Figure 1) is intended to be used in the
Electrophysiology (EP) Lab for the clinical investigation of continuous
intracardiac impedance and heart sounds signals during the defined acute
human study protocol.
2.2.1 INTENDED USE OF THE MODEL 19061 AHM MODULE
The AHM Module contains electronics that control the continuous
stimulation and sensing required to collect real-time intracardiac
impedance signals from a selected electrode vector configuration using
conventional implanted pacing leads/LV catheter. A Model 2090
programmer operating the SOCR investigational software along with the
HVB/LVR3 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 AHM Module also contains electronics
to provide the standard pacing interventions using the conventional
implanted pacing leads/LV catheter needed during the course of the study.
The real-time impedance signal and EGM/markers generated by the AHM
Module are recorded by the data acquisition system.
DSN009462
2.2.2 INTENDED USE OF THE MODEL 19062 HEART SOUND SENSOR DEVICE
The Heart Sound Sensor device is used to collect a real-time heart sounds
signal. Although the Heart Sound Sensor device has a header and shield
graphics indicating that leads can be connected to it, no leads are
connected to the device for the purposes of this study. The device has no
therapy functions. The heart sounds signal is transmitted through
telemetry, using the Viva/Brava software operating on a Model 2090
programmer, and recorded by the data acquisition system.
The Heart Sound Sensor device is provided sterile. It can be temporarily
placed in the subject’s device pocket during an implant procedure, and, for
this purpose, it is single use.
The Heart Sound Sensor device can be cutaneously attached to the
subject post implant, and, for this purpose it can be re-used. See Section
2.3 for cleaning instructions.
Do Not Reuse: The Medtronic Model 19062 Heart Sound Sensor
device is for single patient use only when placed in the subject’s device
pocket.
SOCR System User Guide Page 8 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
22-Apr-2013 16:05 UTC
Rev.
4.0
DSN009462
2.2.3 INTENDED USE OF THE MODEL 15420 PATIENT CABLE
The Model 15420 patient cable is used for connection between the
implanted subject’s pacing leads to the AHM Module. The cable will be
supplied non-sterile. It should be cleaned and steam sterilized prior to use.
All surfaces may be cleaned with water, mild detergent or 70% isopropyl
alcohol. Care should be taken to ensure complete removal of all cleaning
agents. A soft bristle brush may be used to facilitate the cleaning of small
surfaces. During cleaning, the connector block should be opened and the
adaptor area cleaned. The cable may be wiped clean. This cable will enter
the sterile field and therefore must be sterilized prior to use , including first
use. Autoclave the cable under the following conditions: 121 °C (250 °F),
vacuum cycle for 50 minutes.
2.3 C
After completion of the study, the AHM Module should be cleaned using
damp cloth or towel with either water or alcohol based solvent. The
module should not be immersed or exposed to excessive moisture.
Patient cables can be wiped down and must be returned to the clinical
staff for sterilization prior to their next use. After cutaneous use, a Heart
Sound Sensor device can be cleaned using damp cloth or towel with
either water or alcohol based solvent. No special maintenance is required
between uses of the SOCR System.
2.4 W
used for pacing interventions and impedance signal generation. The
Heart Sound Sensor device is to only be used for heart sounds signal
generation. Neither can be used for rescue attempts in the event that
defibrillation, cardioversion or resuscitation is required. Emergency backup
equipment must be available prior to the start of the study.
LEANING AND MAINTENANCE
ARNINGS AND PRECAUTIONS
Warning: The AHM Module supplied by Medtronic is to only be
SOCR System User Guide Page 9 of 27
Revision B April 2013 Medtronic Confidential
Approval date:
Warning: External defibrillator pads should be placed no closer than
2.5 cm to any other study electrodes.
Caution: If an LV catheter is placed, ensure that none of the
unused catheter cable pins present a direct unintended conductive path to
22-Apr-2013 16:05 UTC