St. Jude Medical MediGuide MG1000 Instructions For Use Manual
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St. Jude Medical MediGuide MG1000 Instructions For Use Manual

St. Jude Medical MediGuide MG1000 Instructions For Use Manual

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MediGuide™ Technology
MG1000
Software Version 17.1
Instructions for Use

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Summary of Contents for St. Jude Medical MediGuide MG1000

  • Page 1 MediGuide™ Technology MG1000 Software Version 17.1 Instructions for Use...
  • Page 2 Disclaimer St. Jude Medical shall not be liable nor obligated in any manner in respect of bodily injury and/or property damage arising from the use of this manual if such use is not in strict compliance with instructions and safety precautions contained in the relevant operating manuals and in all supplements thereto, in all product labels, and according to all terms of warranty and sale of this system, nor if any change not authorized by St.

  • Page 3: Table Of Contents

    Contents Preface ................................... 1 Symbols ..................................2 Definitions Acronyms, and Abbreviations ......................... 6 Safety ..................................... 7 Conventions ....................................7 Safety Guidelines ..................................7 Safety Data ....................................9 System Description ............................... 10 Indications for Use ..................................10 Contraindications ..................................10 System Physical Structure ................................10 System Functionalities ................................

  • Page 5: Preface

    This IFU is recyclable. Dispose of all packaging materials as appropriate. Dispose of delivery systems and accessories per standard solid biohazard waste procedures. St. Jude Medical (SJM) recommends contacting SJM Technical Support before removing this system from service and disposing of it.

  • Page 6: Symbols

    Symbols Symbol Definition Defibrillation-proof Type CF equipment Defibrillator-proof type BF applied part Nonsterile Do not reuse Fragile Keep dry Temperature limitations Manufacturer Date of Manufacture Use-by date Lot number Reorder number Serial number Finished good Consult instructions for use Consult instructions for use on this website Do not use if package is damaged Quantity Non-ionizing radiation...
  • Page 7 Notified Body Mark Authorized Representative in the European Community Caution Warning Flammable X-ray radiation Explosion Hazard Electrical Shock Hazard Dangerous Voltage Voltage Hazard Sign ON/OFF button AC Power Internal functional earth terminal Earth (ground) Earth (ground) Software version FUSE, 5 x 20 mm, 10A, 250V, High Breaking Capacity ETL Listed Conforms to UL STD 60601-1...
  • Page 8 Cable Tester Kit Cart CAS Kit (C-Arm Sensor Kit) Cath Connect Cath Connect Bracket Cath Connect Holder Cath Connect Kit Connect Cover Proximity Switch Cover Proximity Switch CPS Component Display ECG (Electrocardiogram) ECG Cable ECG Kit Floor Mount Fuse Keyboard Large Detector Large Detector Upgrade Kit Magnetic Transmitter Assembly...
  • Page 9 Power Splitter Power Supply PRS Patch Rear Mount Real Time Unit Software Installation Software Media Software upgrade kit System System Installation Tool Technology Table Side Unit Upgrade Kit VC21 VC21 Compatible System VD10 Compatible System Workstation XIU (X-Ray Interface Unit) Fluoroscopy Interface Unit...

  • Page 10: Definitions Acronyms, And Abbreviations

    Definitions Acronyms, and Abbreviations Table 1. Definitions, Acronyms, and Abbreviations Cine A recorded fluoroscopy sequence used for playback Cardiac Resynchronization Therapy Coronary Sinus MediGuide™ Connect Electronic Box DICOM Digital Imaging and Communications in Medicine Electrocardiogram Electromagnetic Interference Electrophysiology Fluoroscopy system’s flat detector Frames per second Graphical User Interface Switch located on the bottom left corner of the MediGuide™...

  • Page 11: Safety

    Fuses blown immediately after being replaced may indicate malfunctioning electrical circuits within the system. Do not continue  replacing a fuse if it blows immediately after replacing it. Have the system checked by St. Jude Medical's qualified service personnel, and do not continue to replace the same fuse.
  • Page 12 Fluoroscopy system's Flat Detector. However, a momentary approach to the Fluoroscopy system's Flat Detector is acceptable. Any changes in the Cath Lab configuration should be communicated to St. Jude Medical Technical Support.  X-RAY RADIATION: It is required to follow your facility's internal Radiation Safety Practices.

  • Page 13: Safety Data

     DO NOT bring items containing metallic elements closer than 20 cm (8 inches) to the transmitters. Contact a St. Jude Medical authorized technician when introducing new/untested devices containing metallic elements into the Cath Lab that are intended to stand in vicinity to MediGuide™...

  • Page 14: System Description

    System Description Indications for Use The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip positioning and navigation of a MediGuide Enabled™/Sensor Enabled™ (equipped with a magnetic sensor) invasive device used in vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background.
  • Page 15 The MediGuide™ System is supplied with two monitors to be installed in the control room, while the Cath Lab display is executed by a St. Jude Medical technician in accordance with the configuration of each Cath Lab. Two Cath Lab display options are currently enabled: Two commercially available high resolution color monitors dedicated to the MediGuide™...

  • Page 16: System Functionalities

    System Functionalities Overview MediGuide™ Technology consists of hardware and software elements, which are installed in conjunction with the existing fluoroscopy Imaging System in a Cath Lab. The conventional fluoroscopy Imaging System, equipped with MediGuide™ Technology elements, continues to perform safely and effectively per its intended use as fluoroscopic imaging while enabling device tracking and enhanced visualization tools supplied by MediGuide™...
  • Page 17 Tracking on Images Acquired from Different Angulations In addition to the sensor, the system uses the PRS for correlation of the patient's position and orientation relative to the transmitters. As a result, the current P&O of any MediGuide Enabled™/Sensor Enabled™ device can be projected on a previous X-ray image, even if taken from different C-Arm angulations.
  • Page 18 Tricuspid Valve Right Ventricular Outflow Tract RVOT Right Atrial Appendage Right Inferior Pulmonary Vein Ostium RIPV Right Superior Pulmonary Vein Ostium RSPV Left Inferior Pulmonary Vein Ostium LIPV Left Superior Pulmonary Vein Ostium LSPV Apex Apex Lesion Lesion Catheter Shaft Rendering NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™...
  • Page 19 Angio Survey™ 2D Fusion NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application MediGuide™ Technology features an option to display live fluoroscopy with a fused overlay of any previously recorded acquired fluoroscopy loop, as seen in the next figure. The purpose of this feature is to display previously imaged anatomy (e.g., an angiogram of the anatomy) in a synchronized way while the operator uses live fluoroscopy to view the device and associated MediGuide Enabled™/Sensor Enabled™...
  • Page 20 Angio Survey 2D ROI NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application The 2D ROI may be used to identify the path of the vessel on a selected venogram in order to optimize MediGuide Enabled™/Sensor Enabled™...

  • Page 21: System Limitations

    MediGuide™ Technology. Removal of this filter plate may impact the accuracy of the system. MediGuide™ Technology Interference with Other Systems Before placing a new system/device near a MediGuide™ Technology device, contact a St. Jude Medical authorized technician to find out if any magnetic interference is known to occur.

  • Page 22: User Interface And Operating Controls

    Table 3. System Specifications Type Parameter Value Max Power Consumption Patient Isolation The unit is classified as Class I system continuously operated, ordinary equipment with type BF and CF applied parts. Patient leakage current is limited to the levels specified in IEC-EN-UL 60601-1, 60601-1-1 Nominal Patient Magnetic Field Flux <200 µT @ audio frequency Nominal Personnel Magnetic Field Flux...
  • Page 23 Figure 8. Fluoroscopy and Cine Pedal 1. Cine Pedal 2. Fluoroscopy Pedal Accidentally stepping on this pedal at any time will result in an x-ray with the subsequent known hazards. X-RAY RADIATION The pedal functionality exposes the user and patient to x-ray radiation. Table Side Unit The Table Side Unit (TSU) depicted in next figure is used to select a menu item or activate a button on the MediGuide™...
  • Page 24 To rotate the 3D display: Move the mouse cursor over the 3D display, press the <left> mouse button, move the cursor in the desired directions, and release the mouse button. This action can only be performed in the Secondary Display, when a fluoroscopy image is not being shown.

  • Page 25: Using Mediguide™ Technology

    Using MediGuide™ Technology Conventions The following conventions are used when describing the interaction with the MediGuide™ system: Hardware System Parts are stated in initial caps, e.g., Patient Reference Sensor  System modes are stated in initial caps, e.g., System Mode ...
  • Page 26 Figure 11. MediGuide™ Connect Green and Red LEDs 1. Red LED - The red LED will be either on or blinking when the MediGuide™ System is either in the power-up /shutdown process or in modes indicating system failure. 2. Green LED - If the green LED is blinking, the system power is ON. NOTE: During system power up and shut down, both the red and green LEDs will blink until the MediGuide™...
  • Page 27 Figure 13. System Diagnostic tests completed Select the appropriate application from the MediGuide™ Clinical Screen (refer to the next figure) for the type of procedure to be conducted: Select the Cardiac Navigation Application for electrophysiology ablation procedures. Select the Cardiac Navigation with Angio Survey™ Application for implant procedures. NOTE: Prior to launching an application, ensure that the MediGuide™...
  • Page 28 The selected application will then display (refer to the next two figures). Figure 15. Cardiac Navigation Application Figure 16. Cardiac Navigation with Angio Survey™ Application NOTE: If at any time during MediGuide™ Technology operation there is a need to turn off the magnetic field generated by it, immediate transmission shut-down can be done via the [Turn Magnet OFF] button.
  • Page 29 Figure 18. Turn Magnet ON button Startup Verification Procedure ("Morning Test") This procedure should be performed once a day after powering-up the MediGuide™ System and before starting MediGuide™ Technology procedures. X-RAY RADIATION: The test requires X-ray radiation. Known radiation protection measures should be taken such as using lead aprons, etc.
  • Page 30 NOTE: The last-used PRS number will be selected in a dropdown menu as a default. If a PRS number is already selected, verify that the number matches the connected PRS. From the MediGuide Connect Setup window, define the Morning Test device(s) in the dropdown menu of their corresponding connection port (refer to next figure).
  • Page 31 In the Confirm Start Procedure window, click [Bypass Verification] (refer to next figure). Figure 22. Confirm Start Procedure Verify magnetic system functionality: NOTE: Do not press the fluoroscopy pedal in steps a-d: Hold the Patient Reference Sensor (Motion Sensor) inside the MB and verify the PRS indication is green in the status area as shown in the next figure.
  • Page 32 Repeat step b while raising the Fluoroscopy system's Flat Detector height SID from 90 cm to115 cm (or until out of the MB). Verify that ECG and respiration "flat lines" are refreshed. Close the Morning Test procedure. Disconnect the Morning Test devices and store them. When the PRS is not in use, it should be coiled and stored in the MediGuide™ Connect side panel.

  • Page 33: Preparations For A New Procedure

    Do not use the TSU Power Switch to shut down the system unless absolutely necessary, e.g., if the software becomes completely unresponsive or the software shutdown method is not working. Contact St. Jude Medical Technical Support if this occurs.
  • Page 34 In the Login Screen select the appropriate user name. For clinical procedures, choose the user name "Clinical". Type in the password and FCE Name. Click the [Login] button. Select the appropriate application from the MediGuide™ Clinical Screen for the type of procedure to be conducted: Select the Cardiac Navigation Application for electrophysiology ablation procedures.
  • Page 35 Attach the PRS to the PRS patch as shown in the next figure. NOTE: The PRS should only be attached with a St. Jude Medical™ PRS Patch. The PRS has a locating pin and the patch has a matching groove to ensure that the PRS is oriented in the correct direction and with its motion controlled, as shown in the next figure.
  • Page 36 29 days. The PRS Patch in this package is for use only with the MediGuide™ Technology Motion Sensor PRS and intended for single-use. NOTE: Any adverse skin reactions observed during or after use should be reported to St. Jude Medical Technical Support. ELECTRICAL SHOCK HAZARD: Using a damaged PRS may result in an electric shock to the patient.
  • Page 37 If after connecting the PRS to the MediGuide™ Connect port marked "PRS2" and attaching the PRS into its patch inside the MB, the PRS status in the System Display Status Area remains disconnected, replace the Patient Reference Sensor. If the status remains disconnected after replacing the PRS, contact your St. Jude Medical authorized service representative. Physiologic Monitoring During procedures, the cardiac rate and patient respiratory pattern are monitored and the system compensates for these motions for better projection accuracy.
  • Page 38 NOTE: In some conditions the respiration parameter might not meet system requirements i.e. small respiration amplitude in patients using JET ventilation. If this is the case, the [Ignore Resp] button may be used. The use of this option should be carefully considered before activating.
  • Page 39 Figure 33. 3-connector-ECG cable with labels 1. Right Arm (RA) connector 2. Left Arm (LA) connector 3. Left Leg (LL) connector Verify the PRS and ECG cables are securely connected. Route the wires away from the MB area (close to the neck and shoulders) in order to assure that no visual interference will be caused by the cables.
  • Page 40 The system will analyze the patient ECG and respiration parameters continuously as long as the Patient Setup window is displayed.  When the parameters are suitable for starting a procedure, the [Start Procedure] button's frame will become green. Otherwise, it will be amber.
  • Page 41 Figure 35. Confirm Start Procedure It is recommended to click the [Return to Patient Setup] button and verify readiness. If this is not possible, select [Bypass Verification]. NOTE: Performance may be deteriorated if the verification is bypassed. Specifically, the system might not be Ready for Cine for long periods of time, and projection accuracy on pre-acquired cines may be harmed.
  • Page 42 NOTE: The MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™ are non-sterile. Care must be taken when disconnecting devices to keep the connector end of the cable outside of the sterile field in order to avoid contamination of the sterile field. WARNING: To avoid overheating, do not cover the MediGuide™...
  • Page 43 NOTE: A default color is assigned to each MediGuide Enabled™/Sensor Enabled™ device. The color may be changed by clicking on the corresponding port in the Device Status area and selecting the desired color from the color palette (see next figure). Figure 37.
  • Page 44 Users have the option to turn the rendering of the distal loop on or off by clicking on the device’s corresponding port in the Device Status area and selecting the desired visualization preference. Table 5. Distal loop visualization options Distal loop visible Distal loop hidden Visualization control Device projection in display screen...
  • Page 45 NOTE: "CN" will automatically be added as a prefix to the name of Tool Presets saved in the Cardiac Navigation Application and "CNAS" will automatically be added as a prefix for Tool Presets saved in the Cardiac Navigation with Angio Survey™ Application.

  • Page 46: Mediguide™ Technology Key Features

    Click [Close] to exit. The Landmark Preset will now be saved and listed in the Landmark Presets dropdown menu. It can be loaded before starting a study by selecting it in the Landmark Presets dropdown menu and clicking [OK]. When using the Cardiac Navigation Application, only "CN" Landmark Presets will be available in the dropdown menu and in the Cardiac Navigation with Angio Survey™...
  • Page 47 For mid-size Fluoroscopy system's Flat Detector, the available Detector Zooms are: 39, 32, 26, 20, 16, 10  For large Fluoroscopy system's Flat Detector, the available Detector Zoom modes are: 48, 42, 32, 22, 16, 11  NOTE: Detector Zoom buttons are not functional on the MediGuide™ System's GUI and are only for display purposes. Detector Zoom settings can be modified only on the Siemens Axiom Artis system.
  • Page 48 Figure 45. Primary Monitor Layout - Cardiac Navigation with Angio Survey™ Application 1. Cine List 2. Control area 3. Primary Display screen 4. Edit windows (Edit Landmark, Edit CT/MR, Edit Fiducial) Cine List The Cine List is a list of cines recorded during the procedure. Select to display a specific cine by clicking the arrow next to the cine icon. When Dual Cine is selected, the Cine List enables the action of selecting a cine separately for the left and right display screens by selecting the appropriate arrow next to the cine icon.
  • Page 49 Figure 47. Move cine order Secondary Monitor Figure 48. Secondary Monitor Layout 1. Secondary Display screen 2. Status Area 3. Model List 4. Motion Box Graphics 5. Edit Panel (with Landmark, Lesion and Registration subpanels) Model List A list of 3D models and surface models will appear in the Model List on the Secondary Display. The type of models that may appear in the Model List will depend on the application: Surface models will appear in the Model List in both the Cardiac Navigation and Cardiac Navigation with Angio Survey™...
  • Page 50 Figure 49. Model List in Cardiac Navigation Application NOTE: Multiple surfaces can be imported. Only one registration can be displayed at any given time. The Surface model icon with yellow arrows is currently being shown (refer to previous figure). Figure 50. Model List in Cardiac Navigation with Angio Survey™ Application NOTE: Only one Angio Survey™...
  • Page 51 Figure 51. Status Area Device Status Area Once a tool has been defined in the MediGuide Connect Setup window (see Connecting MediGuide Enabled™ and Sensor Enabled™ Devices (page 38)), it will be displayed in the Device Status area. Tools connected to MediGuide™ Cath Connect will appear in ports A1, A2 and A3.
  • Page 52 Figure 53. System is not ready to record cine If the conditions for recording a valid cine are not met, due to either imaging system geometry or setup, irregular respiration, or heart rate, the readiness for cine indicator will turn amber and the reason for the error will displayed underneath the indicator icons. The next table shows status icons that may be displayed in this area when the PRS is invalid or conditions have not been met to allow for the recording of a cine.
  • Page 53 Figure 54. ECG and Respiration Graphs Motion Box Graphic The Motion Box graphic appears in the Secondary Display to allow users to visualize the location of the PRS and MediGuide Enabled™/Sensor Enabled™ devices within the Motion Box. Connected devices will be visualized by its assigned color. Devices with a Disconnected status will not be displayed.
  • Page 54 Control Area The Control Area is available on the Primary Monitor only. It is divided into two regions, a top banner where certain operations available throughout the procedure are accessible and a bottom banner where the structured functionality tabs and toolbars reside. The operations presented on the top banner are available during the entire procedure, and include: Table 8.
  • Page 55 Figure 58. Procedure tab [New] - Starts a new procedure [Close] - Closes a current procedure [Patient Setup] - Opens the Patient Setup window [LM Presets] - Opens the Landmark Presets window [Import CT/MR] - Import a segmented CT/MR image file [Preview CT/MR] - Opens a dialog box that can be used to preview imported CT/MR image files [Tools] - Opens a software tools window [About] - Displays information about the application version...
  • Page 56 The Cine tab enables stopping the cine playback and selecting a specific frame. It has separate controls for the primary and  secondary (if active) cine displays. When the [Road Map] button is selected, the cine playback is stopped and an individual frame can be selected using the yellow frame selection slider or the frame forward/backward buttons.
  • Page 57 Key Features Available During Procedure After the preparation steps are performed and at least one MediGuide Enabled™/Sensor Enabled™ device is connected to the system and inserted into the patient, the following features are available to the operator according to the procedural sequence of the specific device: Fluoroscopy The operator may take, at any time during a MediGuide™...
  • Page 58 Table 9. Recorded Cines Cine Description Cine Frame (in Cine Tab) Cine List Icon Recorded cine does not have valid region of more than two seconds. No valid cropping region detected. No automatic cropping performed. Invalid cine icon in Cine List. NOTE: Invalid cines will be marked with the amber exclamation point ! in the Cine List, as well as a banner reading Non compensated cine selected.
  • Page 59 Figure 66. Landmark Assignment 1. While in the Landmark tab, select the MediGuide Enabled™/Sensor Enabled™ device that will be used to assign the landmark. 2. Select a landmark. It will be assigned at the the tip of the magnetic sensor of the selected device.
  • Page 60 Figure 68. Landmarks viewed in 3D An assigned landmark or lesion may be customized by the user. Features that may be customized include color, name, size, and orientation. For more information on landmark customization, refer to the section, Customizing a Landmark (page 69). Angio Survey™...
  • Page 61 To control the opacity of the overlay, use the arrow controls at the left of the display (refer to the next figure). Figure 70. Angio Survey™ 2D Fusion Opacity Control To deactivate the Angio Survey™ 2D Fusion, select the Fuse Cine control again. Angio Survey™...
  • Page 62 Figure 71. Angio Survey™ 3D Mark the region of interest (ROI): Refer to the next figure. Starting from the proximal part of the anatomy, mark a point on the left cine by clicking the left mouse button. A line crossing the anatomy (epi-polar line, the projection of the point selected on the left cine) will appear on the right cine image.
  • Page 63 Figure 73. Angio Survey™ 3D model projection on Cine NOTE: If the lumen boundaries of the model deviate from the actual vessel boundaries, use the [Edit Lumen] button to correct them on the primary display. Lumen is edited by dragging the mouse with the left button pressed over the correct path of the wall.
  • Page 64 With Angio Survey™ 2D ROI, it is possible to improve the display of projected devices on the cine playback. 2D ROI will stabilize the tool marker within the ROI and thus help the physician to track the tool especially when moving in small sub-branches. NOTE: A constructed Angio Survey™...
  • Page 65 It is recommended to mark the first point of the 2D ROI distally to the angiogram balloon projection on the screen. NOTE: ROI is not seen onscreen, rather only when a device enters the ROI. When the device is positioned within the assigned ROI position, a magenta-colored ring displays around the device tip.
  • Page 66 Figure 76. Placing fiducial points at tool tip NOTE: If the catheter is moving too fast when a fiducial point is placed, it may not be compensated correctly and the system will display a message suggesting the user delete and replace the fiducial point (see next figure). Figure 77.
  • Page 67 Figure 78. Placing fiducial point at landmark When one or more pairs of fiducial points have been placed, registration can be completed by pressing the [Register] button. NOTE: The registered surface model is a guide to the user which represents a previously acquired anatomy. NOTE: Confirm the catheter position relative to the anatomy using conventional means (e.g., fluoroscopy, intercardiac echocardiography).
  • Page 68 Figure 80. Manual Adjustment of Model 1. Move Cursor – Click and drag with this cursor to move the model on the x- or y-axis 2. Rotate Cursor – Click and drag with this cursor for free 3D rotation. Rotate may only be performed in the Secondary Display.
  • Page 69 1. Delete – Delete selected model or sub surface 2. Undo – Undo last action 3. Redo – Redo last action 4. Move/Rotate – Click button to enable manual adjustment of the selected model (move, rotate, roll) 5. Show/Hide – Show or hide the selected model or sub surface 6.

  • Page 70: Mediguide™ Technology Procedure Guidelines

    MediGuide™ Technology Procedure Guidelines Setup Follow the startup and patient preparation steps as described in the section, Preparations for a New Procedure (page 29). Start a new procedure by pressing the [New] button. Verify the patient procedure data in the appropriate fields in the Patient Data Dialog window (refer to the next figure). This information is automatically obtained from the Siemens Axiom Artis system.
  • Page 71 Use the MediGuide Enabled™/Sensor Enabled™ devices according to the device's user manual, and observe their tracking on the relevant system displays. Once a MediGuide Enabled™/Sensor Enabled™ device is connected and placed in the MB, it will be tracked by the system and displayed in all active display screens, either in 3D or superimposed on fluoroscopy. NOTE: Like any other invasive device, MediGuide Enabled™/Sensor Enabled™...
  • Page 72 A 3D display of the MediGuide Enabled™/Sensor Enabled™ devices and landmarks will show on the Secondary Monitor if the dual cine view is not selected. To select Dual Cine view, use the Dual Cine button in the top banner of the Control Area. Click the left or right arrow next to the cine icon to display the cine on the Secondary Monitor.
  • Page 73 Figure 84. System message - Replace landmark Customizing a Landmark User-assigned landmarks may be customized. To customize a landmark: Select the desired landmark/lesion by clicking on it in a display screen or selecting it from the Landmark or Lesion subpanel. A bounding box will display around the selected landmark or lesion.
  • Page 74 Archive Utility MediGuide™ Technology users may archive and import study data using the Archive utility. Data may be archived to or imported from the following sources - a hospital PACS server, a network drive, a USB device, or a CD/DVD drive. Figure 85.
  • Page 75 Archive Media Navigate to the Archive Media screen in the Archive utility. A list of MediGuide™ Technology studies stored on the hard drive with videos/screenshots will appear. Select the study that contains the media to be archived. A preview window on the right side of the screen will show the videos and screenshots from the study.
  • Page 76 Archive Troubleshooting Settings icon – Click to open the Settings window NOTE: The Settings icon is will only available to SJM-Expert users. This icon will not appear when logged in as a Clinical user. Log icon – Click to open the Log window The Log is used to troubleshoot communication-related issues.
  • Page 77 Reboot the PACS server, and retry the retrieve. If the retrieve is successful, stop here. Increase the Log Level to DEBUG and perform the original retrieve. Call Technical Support to report the problem. Be sure to have logs available. Storage Failed Open the Settings window and click on the PACS Servers tab.
  • Page 78 Figure 86. Media Export Interface...

  • Page 79: User-Level Maintenance

    NOTE: Proceeding without freeing up disk space will result in automatic deletion of the data of the earliest procedure on the disk. Tools Window Description The [Tools] button opens the Tools window (refer to the next figure). It provides the technician's tools options for the St. Jude Medical operator only. Cidex is a trademark of Johnson & Johnson.
  • Page 80 Figure 89. Tools Window Table 11. Utility Button Descriptions Utility name Operation Description Patient Info. Displays patient data Patient data verification during procedure Filter Comp. Cine Removes invalidated cines Acts as a toggle button. When active, eliminates the non-compensated cines from the Cine List MCA Snap Shot Saves real time hardware status As part of troubleshooting...
  • Page 81 Figure 90. Error Log History Window...

  • Page 82: Feedback

    St. Jude Medical Coordination Center BVBA The Corporate Center DaVincilaan 11 Box F1 1935 Zaventum Belguim +32 2 774 68 11 sjm.com In some cases, St. Jude Medical may use on-site satisfaction survey forms. Please help us by completing the form with all relevant details.

  • Page 83: Safety And Compliance Standards

    Safety and Compliance Standards The MediGuide™ Technology in conjunction with any MediGuide Enabled™/Sensor Enabled™ device must meet the safety and compliance standards and requirements listed below. General Safety Description EN 60601-1 (2nd and 3rd Edition) (+amnd. 1,2) General Safety requirements for Medical Electrical Equipment Risk Management Description EN ISO 14971:2012...

  • Page 84: Electromagnetic Emissions & Immunity

    Electromagnetic Emissions & Immunity Guidance and Manufacturer’s Declaration - Electromagnetic Emissions MediGuide™ Technology is intended for use in the electromagnetic environment specified below. The customer or the user of MediGuide™ Technology should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance...
  • Page 85 Immunity Test IEC 60601 Compliance Electromagnetic Environment - Guidance Test Level Level Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part IEC 61000-4-6 150kHz to 80 MHz of MediGuide™ Technology, including cables, than the recommended separation distance Radiated RF 3 V/m...
  • Page 90 Australian Sponsor: St. Jude Medical Australia Pty. Limited 17 Orion Road St. Jude Medical St. Jude Medical Lane Cove NSW 2066 One St. Jude Medical Drive Coordination Center BVBA Australia St. Paul, MN 55117-9913 USA The Corporate Village +1 855 478 5833...

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