Rev.
4.0
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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.
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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.
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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.
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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
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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
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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
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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
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the heart. Capping the unused pins is an acceptable method of
preventing this.
Caution: The AHM Module is not designed to be sterilized or
intended to be used within a sterile field. The module should be used in
conjunction with sterilized patient cables to provide sterile connection to
the subject.
2.5 POTENTIAL ADVERSE EVENTS
Potential adverse events related to the use of SOCR system include, but are not
limited to:
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LV catheter placement risks such as stroke, bleeding, and pro-arrhythmia
Standard CRT system implantation risks
Bleeding and bruising due to use of blood thinners
For a full list of potential adverse events, see the Clinical Investigational Plan.
2.6 CONTRAINDICATIONS
The following contraindications exist for this system:
Patient requires dual chamber cardiac pacing or single chamber
(ventricular) pacing at rest for rate support
Recent echocardiogram (within the last 6 months) has revealed the
presence of an LV thrombus
For further details and a complete list of inclusion/exclusion criteria, see the
Clinical Investigational Plan.
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3. SYSTEM SETUP
3.1 BIOPAC SYSTEM OVERVIEW
All analog output signals from the AHM Module, 2090A/B Analog Output
Modules, and Millar PCU-2000 will be independently connected via a supplied
connection cables to separate analog input channels on the Biopac MP150 Data
Acquisition System with the Biopac UIM100C module (Figure 2). Additional
physiologic input signals such as ECG, blood pressure, blood pressure
plethysmography or any other physiologic signals, per implanting physician’s
discretion, may also be connected to an unassigned input channel on the Biopac
UIM100C (Figure 3) to monitor the subject’s vital signs. Available physiologic
signals can be recorded simultaneously with the above signals but are not
required by Medtronic to obtain the study objectives.
Data will be acquired through the AcqKnowledge®(Ver 4.0 or later) data
acquisition software via the Biopac MP150 / UIM100C and supplied laptop
computer.
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Figure 2. Biopac MP150 Data Acquisition System with Biopac UIM100C Module.
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Table 2. Connections to t
he Biopac System
Channel
Description
Connection Method
Rev.
4.0
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Figure 3. Depicts an example of an external physiologic signal connection to the UIM100C
Analog Input Channel Array via provided custom cables.
3.2 C
ONNECTIONS TO THE BIOPAC SYSTEM
Table 2 depicts assigned connections to the Biopac MP150 and UIM100C analog
input channels:
Input
1 ECG Cable from an ECG source available in the lab
2 EGM1 Cable from Output B of 2090A/B Analog Output Module
connected to AHM Module programmer
3 EGM2 Cable from Output C of 2090A/B Analog Output Module
connected to AHM Module programmer
4 Markers Cable from Output D of 2090A/B Analog Output Module
connected to AHM Module programmer
5 Impedance vector toggle Cable from HVB/LVR3 output of AHM Module
6 Pace blanking Cable from IBLANK output of AHM Module
7 Impedance Cable from AOUT output of AHM Module
8 Impedance gain Cable from Gain output of AHM Module
9 Heart sounds Cable from Output B of 2090A/B Analog Output Module
10 LV Pressure Cable from PCU-2000
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connected to Heart Sound Sensor programmer
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Table 3. Connections
to the AHM Module
Connection
Connection Method
Rev.
4.0
All connections to the Biopac MP150 interface are made using cables provided
by Medtronic.
3.3 CONNECTIONS TO AND USE OF THE AHM MODULE
Table 3 depicts channel connections to the AHM Module’s rear (Figure 4), and
front panels (Figure 5). The LV TIP, and LV RING 1-3 connections only apply
when an LV catheter is placed. When an LV catheter is placed, select the distal
electrode on the LV catheter as electrode AA. Select electrodes BB, CC, and DD
such that the edge-to-edge distance between BB and AA is closest to 21mm,
between CC and BB is closest to 1.3mm, and between DD and AA is closest to
46mm.
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HVB/LVR3 Cable to Biopac UIM100C Analog Input Channel 5
I BLANK Cable to Biopac UIM100C Analog Input Channel 6
AOUT Cable to Biopac UIM100C Analog Input Channel 7
GAIN Cable to Biopac UIM100C Analog Input Channel 8
PATIENT CABLE Model 15420 Patient Cable to sterile field for connection to subject
pacing leads
LV TIP Cable to LV catheter electrode AA (if LV catheter is placed)
LV RING 1 Cable to LV catheter electrode BB (if LV catheter is placed)
LV RING 2 Cable to LV catheter electrode CC (if LV catheter is placed)
LV RING 3 Cable to LV catheter electrode DD (if LV catheter is placed)
Model 2067 or 2067L
Programming Head
Programmer Head for Model 2090 Programmer
Except for the LV catheter, all connections to the AHM Module are made using
cables provided by Medtronic. LV catheter cables are provided by the LV
catheter manufacturer.
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Figure 4. Rear panel of the AHM Module
SERIAL NUMBER
XXXXXXXXXX
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Leave the GAIN switch on the front panel in the “x8” position for the study.
Place the programming head in the designated area on top of the AHM Module.
The unit is powered by 6 AA lithium batteries. The unit takes 3.6V batteries,
supplied by Medtronic. Replace the batteries prior to each subject use.
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Figure 5. Front panel of the AHM Module.
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Table 4. Connections to t
he
Subject
Cable
/ Label
Subject
Connection
Rev.
4.0
Warning: Do not dispose of the lithium batteries in the unsorted
municipal waste stream. Dispose of the batteries according to local regulations.
Power to the unit is turned on and off by use of the power switch labeled
“POWER” with the conventional on/off switch positions. The power must be
applied to the AHM Module during use.
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3.4 C
ONNECTIONS TO THE SUBJECT
Table 4 and Figure 6 show the patient cable connections in the sterile field for
device connection to the subject. Run an impedance test using the SOCR
software to verify that all leads are properly connected.
Medtronic
Model
15420
RV-DF4 Connection to subject’s RV-DF4 lead (if applicable)
LV-IS4 Connection to subject’s LV-IS4 lead (if applicable)
RA-IS1 Connection to subject’s RA-IS1 lead
LV-IS1 Connection to subject’s LV-IS1 lead (if applicable)
HVB-DF1 Connection to subject’s HVB-DF1 leg of RV IS1/DF1 lead (if
applicable)
RV-IS1 Connection to subject’s RV-IS1 leg of RV IS1/DF1 lead (if
applicable)
SVC-DF1 Connection to subject’s SVC-DF1 leg of RV IS1/DF1 lead (if
applicable)
Figure 6. Medtronic Model 15420 Patient Cable for AHM Module connection to subject’s pacing
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3.5 I
S
OFTWARE
NSTALLING AND UNINSTALLING THE
SOCR I
NVESTIGATIONAL
Refer to Appendix A for instructions on how to install the SOCR Investigational
Software onto a Model 2090 Programmer. The installation only needs to be done
once per programmer.
When the clinical study is complete, the software must be uninstalled from all
Medtronic Model 2090 CareLink Programmers on which it was installed. Refer to
Appendix B for instructions on how to uninstall the SOCR Investigational
Software.
3.6 S
TARTING THE
SOCR I
NVESTIGATIONAL SOFTWARE
After installing the SOCR Investigational Software application on the
programmer, do the following to access it:
1) Turn the Medtronic Model 2090 CareLink Programmer’s power On.
2) If the Find Patient window is displayed, select Cancel.
3) Select “Programmer” from the icons on the right side.
4) Select “Other Software” from the options displayed.
5) Select “SOCR Rev. 1.0 – For Investigational Use Only” from the list
displayed.
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6) Select Start.
7) After about 5 seconds, the SOCR Investigational Software will be
activated and the system is ready for use.
After using the software, select the End Session button to go back to the Other
Software screen.
3.7 S
OFTWARE SETUP FOR THE
AHM M
ODULE
The programmer used with the AHM Module must have the SOCR
Investigational Software installed (see section 3.5 ).
Follow the steps below for proper use of the programmer with the AHM Module:
1) Ensure that the AHM Module’s power is on and that neither battery low
indicator is set.
2) Follow the steps in section 3.6 to start the software.
3) Press Interrogate… and then Start.
4) Clear the electrical reset and press Continue.
5) Disable ALL therapies and ALL detection parameters. (Params>Pacing)
6) Place the device in DDD mode. (Params>Pacing)
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7) Set V. Pacing is set to LV->RV. (Params>Pacing>CRT)
8) Ensure that LV Pace Polarity is set to LV1 to RVcoil. (Params>Pacing)
9) Disable the following features: (Params>Pacing)
a. Capture Management (Amplitude/Pulse Width)
b. Rate Adaptive AV (AV Intervals)
c. V. Sense Response (Arrhythmia/Post Shock)
10)Program the following:
a. LV amplitude to a minimum of 3V.
b. LV pulse width to a minimum of 0.4 ms.
c. RV amplitude to a minimum of 3V.
d. RV pulse width to a minimum of 0.4 ms.
e. A amplitude to a minimum of 3V.
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f. A pulse width to a minimum of 0.4 ms.
11)Program the following:
a. EGM1 Source to RVtip to RVring.
b. EGM3 Source to LV1 to RVcoil.
c. Impedance Vector to RV to LV Distal.
12)Enter the live waveform screen. Position EGM1 above EGM3. Select
EGM1 and EGM3 for printing.
13)Set Lower Rate and Paced AV to achieve AV sequential pacing.
(Params>Pacing)
14)Observe that atrial and biventricular pace markers are occurring.
15)Set the pacing mode to ODO.
AHM Module software setup is complete.
Be sure to power down the AHM Module prior to the completion of the study.
Sensing performance and pacing thresholds should already be assessed as a
part of the lead implant prior to the start of this study. Refer to the investigational
Viva/Viva Quad, Brava/Brava Quad CRT-D Reference Manual for any additional
instructions on interfacing with the Model 2090 Programmer.
Capture thresholds will be monitored and adjusted as needed to maintain
consistent capture; adequate safety margins will be used. EGM signals will be
monitored and sensing thresholds will be adjusted as needed to maintain proper
sensing.
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3.7.1 PROGRAMMING IMPEDANCE VECTORS
The SOCR Investigational Software provides the capability of programming the
Impedance Vector to any of six possible values from the Params->Data
Collection Setup screen. Note that the HVB/LVR3 switch on the front panel of the
AHM Module must be set to the proper position when programming the last two
selections.
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3.8 SOFTWARE SETUP FOR THE HEART SOUND SENSOR DEVICE
The programmer used with the Heart Sound Sensor device must have the
Viva/Brava software installed. Contact the Medtronic Clinical Study Team if the
software is not installed on your programmer.
Power up the programmer.
Follow the steps below for proper use of the Model 2090 Programmer with the
Heart Sound Sensor device:
1) When the Find Patient screen is displayed, ensure that the “Use Wireless”
checkbox is selected.
2) Place programming head over the Heart Sound Sensor device until the
programmer recognizes the device, then return the programming head to
the programmer tray.
3) Wait for the interrogation to complete. If a pop-up message specifying
electrical reset is displayed during this process, do not proceed with this
Heart Sound Sensor device (repeat setup for a backup device if available).
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4) Navigate to the Parameters screen and ensure that EGM3 is set to LV3 to
LV4 with +/-4mV range and that Pacing Mode is ODO.
5) Enter the live waveform screen. Position EGM3 above all other waveforms
and select for printing.
6) Ensure that EGM3 (heart sounds signal) amplitude is at least above half of
the dynamic range but without signal clipping. Adjust EGM3 Range to +/2mV or +/-8mV, even +/-16mV as needed.
The heart sounds signal is now being transmitted, and Heart Sound Sensor
device software setup is complete.
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Setup
Procedure
Perform Last:
Rev.
4.0
4. SETUP TEST PROCEDURE
The following setup procedure must be completed prior to protocol initiation.
These steps are not in any particular order, except for the last step, which must
be executed last.
Confirm that each 2090A/B Analog Output Module is connected to its respective
Medtronic programmer.
Confirm Output B of the 2090A/B Analog Output Module connected to the Heart
Sound Sensor programmer is connected to the Biopac MP150 as outlined in section
3.2, Table 2.
Confirm Output B, Output C, and Output D of the 2090A/B Analog Output Module
connected to the AHM Module programmer are connected to the Biopac MP150 as
outlined in section 3.2, Table 2.
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Confirm the output cables on the rear panel of the AHM Module are connected to the
applicable Biopac MP150 analog input channels as outlined in section 3.2, Table 2.
Confirm ECG is connected to the Biopac MP150 as outlined in section 3.2, Table 2.
Confirm the Millar PCU-2000 output is connected to the Biopac MP150 as outlined in
section 3.2, Table 2.
Confirm the Ethernet cable is connected from the Biopac MP150 to the laptop
computer.
Confirm 6 new 3.6V AA lithium batteries have been placed in the AHM Module as
shown on the front panel, Section 3.3, Figure 5, and that neither battery low indicator
is set. Also confirm that the GAIN switch is in the “x8” position. Turn power on.
Confirm the Medtronic patient cable is connected to the PATIENT CABLE input on the
front panel of the AHM Module.
Confirm the Medtronic programmer head of the AHM Module programmer is
positioned on the top of the AHM Module as outlined in section 3.3, Table 3.
Confirm that the AHM Module programmer setup as outlined in section 3.7 has been
completed, and the atrial and ventricular pace markers occurred as expected.
Confirm that the Heart Sound Sensor programmer setup as outlined in section 3.8
has been completed.
If an LV catheter has been placed, confirm the LV catheter cables are connected to
the front panel of the AHM Module as outlined in section 3.3, Table 3 and Figure 5. If
an LV catheter has not been placed, confirm that there are no connections to those
inputs.
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Confirm that the pacing leads have been connected to the Model 15420 patient cable
and that the impedance test shows proper connections.
Confirm the Millar pressure catheter is connected to the Millar PCU-2000.
signals for ECG, EGM, impedance, heart sounds, and LV pressure, and that the
markers, IBLANK, GAIN, and HVB/LVR3 signals are appropriate.
Confirm that the laptop computer is displaying physiological-looking
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APPENDIX A – INSTALLING THE SOCR INVESTIGATIONAL SOFTWARE
To use the SOCR Investigational Software with a Medtronic Model 2090
CareLink Programmer, the software must first be installed on a programmer
running Vision Release 2.5 or later. To determine the Vision Release on a 2090
programmer, select the Programmer icon from the main screen. Select Software
from the dropdown list. Verify the 2090 programmer lists Vision Release 2.5 or
higher. If the programmer release is not current or correct, ask your Medtronic
representative about updating the programmer software. The installation of the
SOCR Investigational Software only needs to be done once per programmer.
Installation requires use of a network connection to access the Medtronic
Software Distribution Network (SDN). The SDN uses a world-wide private
network to connect to servers. If you have not yet used SDN, you will be
prompted to enter in a Programmer Profile during the install. Follow the
Programmer Reference Guide provided with the Medtronic Model 2090 CareLink
Programmer to fill in this information. To install the Investigational Software
application on your programmer using SDN:
DSN009462
1) Contact the Medtronic Clinical Study Team to add your programmer serial
number to the approved SOCR Investigational Software list.
2) Turn the programmer’s power On. Connect the programmer to a network,
either wired, wireless, or dial-up.
3) Select the Programmer icon.
4) Select Software from the menu.
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5) Select Install from Medtronic…
DSN009462
6) US Only: Press Accept to agree to the terms of the installation agreement.
The download will begin. Note that the manuals available on the
Medtronic website are for market released products only, including the
device and 2090 programmer being used during this study.
7) If the programmer has a combo card installed, the Install from Medtronic Schedule Software Update window appears showing the LAN connection
by default. You may configure this connection by selecting Configure. If
the programmer has a modem card installed, you can ignore this step.
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8) Type in your Medtronic password on the Start Software Update window.
9) The Update Software window will appear to start the installation. Review
this window to verify the current settings.
DSN009462
10) Press Start to begin the software download. The screen will temporarily
go blank and reboot while connecting to the SDN and installing the
software.
11) When the installation is complete, the Software on This Programmer
screen shows the SOCR Investigational Software application and the
Time of Update.
12)For further instructions on accessing the SDN installation, see the
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Medtronic CareLink Programmer for Model 2090 Programmer Reference
Guide, available on the Medtronic Manuals website.
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4.0
APPENDIX B – UNINSTALLING THE SOCR INVESTIGATIONAL SOFTWARE
When the clinical study is complete, the software must be uninstalled from all
Medtronic Model 2090 CareLink Programmers on which it was installed. If the
software needs to be re-installed onto the same programmer after it has been
uninstalled, contact Medtronic for assistance.
1) Turn the programmer’s power On.
2) Select the Programmer icon.
3) Select Software from the menu.
DSN009462
4) Select Uninstall Software...
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5) On the Uninstall Software screen, select the SOCR Investigational
Software application. Press Uninstall.
DSN009462
6) An Uninstall Software warning window will appear to confirm the uninstall
of SOCR. Verify that the software to be removed is SOCR, accept the
term of this uninstall, and press Continue.
7) The Software on This Programmer screen is updated to display the SOCR
Investigational Software Uninstall update.
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Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Internet: www.Medtronic.com
Tel. +1-763-514-4000
Fax +1-763-514-4879
Medtronic E.C. Authorized
Representative/Distributed By
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. +31-45-566-8000
Fax: +31-45-566-8668
DSN009462
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