DSN009462 Rev. 4.0 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.
DSN009462 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. Do not dispose of this product in the unsorted municipal waste stream. Dispose of the product according to local regulations.
DSN009462 Rev. 4.0 Table of Contents 1. 2. 3. Physical Characteristics.................................................................................4 1.1 System Components ..........................................................................4 1.2 Power Source......................................................................................4 1.3 Intended Use Environment ................................................................5 System Overview....................................
DSN009462 Rev. 4.0 1. 1.1 PHYSICAL CHARACTERISTICS SYSTEM COMPONENTS Components included as part of the SOCR research system are shown in Table 1. Table 1.
DSN009462 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.
DSN009462 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.
DSN009462 Rev. 4.0 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.
DSN009462 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.
DSN009462 Rev. 4.0 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.
DSN009462 Rev. 4.0 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.
DSN009462 Rev. 4.0 3. 3.1 SYSTEM SETUP 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).
DSN009462 Rev. 4.0 Figure 3. Depicts an example of an external physiologic signal connection to the UIM100C Analog Input Channel Array via provided custom cables. 3.2 CONNECTIONS TO THE BIOPAC SYSTEM Table 2 depicts assigned connections to the Biopac MP150 and UIM100C analog input channels: Table 2.
DSN009462 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.
DSN009462 Rev. 4.0 SERIAL NUMBER XXXXXXXXXX Figure 4. Rear panel of the AHM Module Figure 5. Front panel of the AHM Module. 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.
DSN009462 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. 3.4 CONNECTIONS TO THE SUBJECT Table 4 and Figure 6 show the patient cable connections in the sterile field for device connection to the subject.
DSN009462 Rev. 4.0 3.5 INSTALLING AND UNINSTALLING THE SOCR INVESTIGATIONAL SOFTWARE 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.
DSN009462 Rev. 4.0 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 SOFTWARE SETUP FOR THE AHM MODULE The programmer used with the AHM Module must have the SOCR Investigational Software installed (see section 3.5).
DSN009462 Rev. 4.0 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.
DSN009462 Rev. 4.0 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.
DSN009462 Rev. 4.0 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.
DSN009462 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. Setup Procedure 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.
DSN009462 Rev. 4.0 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.
DSN009462 Rev. 4.0 5) Select Install from Medtronic… 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.
DSN009462 Rev. 4.0 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. 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.
DSN009462 Rev. 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. 4) Select Uninstall Software...
DSN009462 Rev. 4.0 5) On the Uninstall Software screen, select the SOCR Investigational Software application. Press Uninstall. 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.
DSN009462 Rev. 4.0 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.
