1. Manuals
  2. Brands
  3. Gotop Manuals
  4. Medical Equipment
  5. RigiScan Plus
  6. User manual

Gotop RigiScan Plus User Manual

Hide thumbs Also See for RigiScan Plus:
Table of Contents

Advertisement

Quick Links

User Guide
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the RigiScan Plus and is the answer not in the manual?

Questions and answers

Related Manuals for Gotop RigiScan Plus

Summary of Contents for Gotop RigiScan Plus

  • Page 1 User Guide CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
  • Page 2 (User Guide) ©2016 GOTOP Medical This manual pertains only to the GOTOP Medical RigiScan® Plus System. All rights reserved. Printed in the U.S.A. U.S. Patent Nos. 4,515,166 and 4,766,909 apply. Le présent manuel ne s’applique qu’au système RigiScan® Plus d’’GOTOP Medical . Tous droits réservés. Im- primé...
  • Page 3 Chapter 4: Preparing the RigiScan Plus System for Patient Testing ......
  • Page 4 Chapter 6: RigiScan Plus Reports........

  • Page 5: Chapter 1: Introduction

    Adequate patient education is required to assure safe operation of the RigiScan Plus by a patient for in-home nocturnal testing. • DO NOT use the RigiScan Plus Monitor if the tension guide boots are loose, the cable is kinked or curled, or the tension guide is crushed or broken. Use of worn or damaged tension guides may result in patient injury.
  • Page 6 • DO NOT turn the RigiScan Plus Monitor “on” until the loops have been placed on the penis. Turning the monitor on before placing the loops will cause continuous rigidity sampling and may result in patient discomfort, pain, irritation or bruising.

  • Page 7: Principles Of Operation

    10 ounces (283.5g). The RigiScan Plus Monitor takes a measurement when this force is applied to record a cross sectional response to radial compression. This is how rigidity is measured.

  • Page 8: The Rigiscan Plus Monitoring System

    Fig. 1-1 Optional Accessories: • Rechargeable Batteries and Charger are available for purchase from GOTOP Medical Inc. NOTE: Excluding the customer provided EN60950 compliant PC, all components of the RigiS- can system are suitable for use in the patient environment.

  • Page 9: Chapter 2: Setting Up The Rigiscan Plus System

    The RigiScan Plus Monitor connects to your computer with the supplied communication cable. The 15-pin male connector attaches to the RigiScan Plus Monitor (Fig. 2-1) and the USB plug attaches to an available USB 2.0 port on the computer (Fig. 2-2).

  • Page 10: Connecting The Event Marker (Optional)

    ® (User Guide) 2.3 Connecting the Event Marker (Optional) You can use the optional Event Marker to mark pertinent points in the patient data. To connect the Event Marker cable: Connect the small, round 4-pin connector on the communications cable to the round connector on the Event Marker cable.

  • Page 11: Installing The Rigiscan Plus Software

    4. Double click the RigiScan-Inst (v5.03).exe excecutable file. Note: You may need Administrator Priveleges to install software in Windows. 5. When prompted, click Next in the installer window to begin installation. The RigiScan Plus software will begin installing as indicated by a progress bar. -11-...
  • Page 12 ® (User Guide) When the progress bar reaches 100%, installation of the USB to Serial Driver will automatically begin as indicated by the pop-up window below. When installation of the USB to Serial driver is complete, click Exit to finish installation. -12-...

  • Page 13: Chapter 3: Software Operation

    1. Double-click the RigiScan icon on the desktop 1. Click the Start button on the task bar 2. Navigate to All Programs -> GOTOP Medical RigiScan PLUS 3. Click RigiScan When running RigiScan for the first time you may be prompted to enter licensing information.

  • Page 14: The Rigiscan Plus Home Screen

    ® (User Guide) 3.2 The RigiScan Plus Home Screen When you start the RigiScan Plus software, the RigiScan Plus Home Screen will appear in a new window. A column of buttons, along with functional descriptions of each are provided. • RigiScan - opens the RigiScan Control window (see Section 3.3) •...

  • Page 15: Rigiscan Control Window

    3.3 RigiScan Control Window Clicking the RigiScan button on the RigiScan Plus Home Screen opens the RigiScan Control window. Here the user may download session data from a previous ambulatory or real-time monitoring session, initialize the device for a new patient, or start a Real-Time Monitoring session.

  • Page 16: Initializing The Monitor

    ® (User Guide) Initializing the Monitor To Initialize the Device (New Patient): 1. Click the Initialize Device button in the RigiScan Control window. This opens the Device Ini- tialization window. 2. Click the Add New button to add a new patient. This opens the Patient Information window. 3.
  • Page 17 To Start Monitoring Session: See Chapter 5: Patient Testing for details on starting Real-Time and Ambulatory Monitoring Sessions. To Download Patient Data (following a monitoring session): 1. Following an ambulatory or real-time monitoring session, connect the device to the PC via the supplied communication cable.

  • Page 18: Patient Management Window

    (User Guide) 3.4 Patient Management Window Clicking the Patient Mgmt button on the RigiScan Plus Home Screen opens the Patient Management window. Here, the user may add, view, edit, delete, import, and export patient records. To aid in viewing, editing, and deleting patient records, a search feature as well as quick search but- tons are available along the left side of the window.
  • Page 19 Patient Information window. 7. Click the button in the Patient Information window to save patient data. 8. Click the button to return to the RigiScan Plus Home Screen. 9. When prompted with the Confirm Close pop-up window, click OK. -19-...
  • Page 20 5. Click the button to save patient record. 6. Click the button to return to the RigiScan Plus Home Screen. 7. When prompted with the Confirm Close pop-up window, click OK. To Edit an Existing Patient Record: 1. Click the Patient ID of the record you wish to edit, then click the button to open the Pa- tient Information window.
  • Page 21 To View Existing Patient Data: 1. Double-click the Patient ID of the record you wish to view. 2. Use the tabs along the left side of the Patient Information window to view General, Treatment History, and RigiScan tabs. To View Existing RigiScan Monitoring Data: 1.
  • Page 22 ® (User Guide) 4. From the graph screen, you can set the horizontal scale with the Scale drop down menu; set a threshold to be displayed on any of the graphs using the Thresh. button; print the graphs using the Print button; or return to the Session Scan Summary window using the button.
  • Page 23 To Select an Interval to View Selected Information: 1. In the graph screen, you can get more detailed information by clicking and dragging anywhere in the graph. A gray shaded region will appear. Simply release the mouse button to end the selection of the shaded region and it will then appear on all 4 charts. 2.
  • Page 24 ® (User Guide) To Show Selection Info of the Selected Region 1. Selecting the Show Selection Info from the context menu displays a pop-up giving you more information. 2. From this pop-up, you can see the starting and ending information including the timestamp, tip and base rigidity, tip and base tumescence, and the duration of that interval.

  • Page 25: Report Manager Window

    3.5 Report Manager Window Clicking the Reports button on the RigiScan Plus Home Screen opens the Report Manager Window. Here the user may generate customized reports for individual or multiple patients. Clicking the button in the upper right corner of the Report Manager Window brings the user back to the RigiScan Plus Home Screen.

  • Page 26: Filtering Available Patients

    ® (User Guide) Filtering Available Patients When a large database of patients exists, it may be useful when creating a report to filter the available patients based on certain parameters. Clicking the Filter Options button in the Report Manager window opens the Report Filter Options window, where (via drop-down menus) the user can filter available patients based on Primary Etiolo- gy, Rx Treatment, and/or RigiScan Data Type.

  • Page 27: Report Selector

    Clicking the Select button opens a print dialog box which allows the user to specify the desired print- er. Pressing the Cancel button closes the Report Selector window. For details on the information provided in each report, see Chapter 6: RigiScan Plus Reports. -27-...

  • Page 28: Data Management Window

    (User Guide) 3.6 Data Management Window Clicking the Data Mgmt button on the RigiScan Plus Home Screen opens the Data Management Window. Here the user may backup the database, restore a previous database, cleanup the current database, and specify patient records as active or archived status.
  • Page 29 To Restore a previously backed up database: 1. To avoid inadvertant loss of data, it is recommeded to always backup the current database prior to using the Restore feature. The Restore feature completely overwrites the current database. 2. Click the Restore button in the Data Management window. 3.
  • Page 30 ® (User Guide) To Clean Up database: 1. To avoid the inadvertant deletion of important data, it is strongly recommended to backup the database prior to using the DB Clean Up feature. 2. Click the DB Clean Up button. 3. When prompted, select the “Delete Before:” date. All patient treatment history prior to the select- ed date will be deleted.
  • Page 31 1. Click the Archive button to open the Archive Manager window. 2. From this window, the user may select patient records to archive or un-archive (set as active). 3. Clicking the button closes the Archive Manager window and re-opens the RigiScan Plus Home Screen. To Archive a specific patient record: 1.
  • Page 32 4. Click the button to save the changes to patients’ statuses. 5. Clicking the button closes the Archive Manager window and re-opens the RigiScan Plus Home Screen. To Un-Archive a specific patient record: 1. Click the Patient ID of the desired record to un-archive.

  • Page 33: Rigiscan Settings Window

    3.7 RigiScan Settings Window Clicking the Settings button on the RigiScan Plus Home Screen opens the RigiScan Settings Window. Click-able tabs along the left side of the window allow the user to navigate to different sections of the Settings Window to customize the RigiScan Plus application for their particular needs.
  • Page 34 ® (User Guide) Serial Port Selection: 1. Select the COM port that corresponds with the desired RigiScan. They are identified as “COM#” where the # is a number assigned by the Windows operating system. NOTE: USB connected devices and Serial Port connected devices that use a Serial-to-USB Adapter will still appear as COM port devices even though they are attached to the PC via one of its USB ports.
  • Page 35 Other Settings: Auto Print Graphs: This option allows the automatic printing of the Rigi Session Graphs once the downloading of session data is complete. This is where the default setting of this option is set. This set- ting can be temporarily overridden from the Data Download Options pop-up window (see Section 3.3 for RigiScan Control Window), but the default setting will be used upon the next Data Download.

  • Page 36: Rx Codes Tab

    3. Click the button to add the new treatment code and description. 4. Click the button in the upper right corner to save changes and return to the RigiScan Plus Home Screen. To delete an existing code and description: 1. Click the line you wish to delete.

  • Page 37: Drug Codes Tab

    3. Click the button to add the new drug code and description. 4. Click the button in the upper right corner to save changes and return to the RigiScan Plus Home Screen. To delete an existing code and description: 1. Click the line you wish to delete.

  • Page 38: Prosthesis Codes Tab

    3. Click the button to add the new prosthesis code and description. 4. Click the button in the upper right corner to save changes and return to the RigiScan Plus Home Screen. To delete an existing code and description: 1. Click the line you wish to delete.

  • Page 39: About Tab

    The About tab displays product information including • Application Name • Application Version • Application Release Date • GOTOP Medical Contact Information • Product Registration Information It also allows the user to change to whom the software is registered by clicking (Change). -39-...

  • Page 40: Chapter 4: Preparing The Rigiscan Plus System For Patient Testing

    4.1 Installing the Tension Guides Prior to each use, inspect the RigiScan Plus Monitor’s Tension Guides, cables and loops to determine that all parts are in good working order. Replace the Tension Guides if the cables are kinked, frayed or worn, the boots are loose or otherwise worn or damaged, or the tension guides are crushed or broken.

  • Page 41: Removing The Tension Guides

    Tension Guides too quickly may damage the monitor or result in an ‘out-of-phase’ condition and inability to re-insert the tension guides. 1. Verify that the RigiScan Plus Monitor is turned off. 2. Unscrew the plastic retention nut on the Tension Guide at the monitor end of the Tension Guide.

  • Page 42: Installing The Loop Covers

    ® (User Guide) 4.2 Removing the Tension Guides (continued) 4. Push the Tension Guide into the Tension Guide housing on the monitor and turn approximately 1/4 turn counterclockwise until the metal pin moves out of the slot at the far right of the housing. 5.

  • Page 43: Removing The Loop Covers

    10-hour session. Fig. 4-5 NOTE: The RigiScan Plus Monitor’s internal lithium battery must be replaced by a qualified GOTOP Medical service technician a minimum of one (1) time per year. -43-...

  • Page 44: Attaching The Leg Strap

    NOTE: If physical disabilities prohibit the patient from attaching the leg strap to his thigh, a waist strap is supplied to allow the patient to wear the RigiScan Plus Monitor around his abdo- men. Connect the two straps together and wrap them around the patient’s waist, with the pock- et centered over his penis.

  • Page 45: Chapter 5: Patient Testing

    The data that is collected is then downloaded to an IBM compatible computer for evaluation by the cli- nician. To prepare the RigiScan Plus Monitor for a new study, you must be sure that you have initialized the RigiScan Plus Monitor with the patient’s proper information. For instructions on how to initialize the RigiScan Plus Monitor, see Initializing the Monitor in Chapter 3 of this manual.

  • Page 46: Instructing The Patient

    When a patient is being tested in the ambulatory mode at home, you need to explain how to use the RigiScan Plus Monitor, including giving instructions on how to put it on, start it, and change the batter- ies. A characterization session is provided for patient education. See section 5.4. Instruct the patient to wear loose fitting clothing when wearing the RigiScan Plus Monitor, such as pajamas or boxer shorts.

  • Page 47: Testing Patients Using The Real-Time And Ambulatory Modes

    2. Initialize the RigiScan Plus Monitor. (See Initialize the Monitor in Chapter 3.) 3. Attach the RigiScan Plus Monitor to the patient’s leg. (See Attaching the Leg Strap in Chapter 4.) 4. Attach the RigiScan Plus Monitor Loops to the patient’s penis: First, fit the BASE Loop (blue boot) over the patient’s penis and position it at the base of the penis.

  • Page 48: Ambulatory Testing

    Provocative Real-time Mode Graphs screen will appear. Otherwise, the Nocturnal Real-time Mode Graphs will appear. 8. Hold the loops in their proper positions until the RigiScan Plus Monitor tightens them. The Base Loop will tighten first, followed by the Tip Loop. The loops will not tighten until you have clicked Real Time Monitoring.
  • Page 49 7. Disconnect the communications cable. 8. Attach the RigiScan Plus Monitor to the patient’s leg. (See Attaching the Leg Strap in Chapter 4.) 9. Attach the RigiScan Plus Monitor Loop to the patient’s penis: First, fit the BASE Loop (blue boot) over the patient’s penis and position it at the base of the penis.

  • Page 50: Beep Cues

    Beep Cues Each time the patient turns the RigiScan Plus Monitor on, it will emit a series of beep tones to indicate that the device is active and which session it is ready to record. For example, the first session is indicated by a single beep, the second by two beeps, and so on.

  • Page 51: Chapter 6: Rigiscan Plus Reports

    Chapter 6: RigiScan Plus Reports 6.1 The Session Scan Summary Report The RigiScan Plus Session Scan Summary Report allows you to see the results of previously download- ed sessions. These are the fields that appear on the Session Scan Summary Report.

  • Page 52: The Summary Analysis Statistic Report

    (User Guide) 6.2 The Summary Analysis Statistic Report The RigiScan Plus Summary Analysis Statistics Report provides a comprehensive review of the dura- tion of events, their averages, and baselines. It includes as many as three data collection sessions, and provides individual and composite views for all three sessions. These are the fields that appear on the Summary Analysis Statistics Report: Start and Stop Times and Duration.

  • Page 53: Printing Session Scan Summary And Summary Analysis Statistics Reports

    6.3 Printing Session Scan Summary and Summary Analysis Statistics Reports To Print the Session Scan Summary Report: 1. Navigate to the RigiScan tab of the Patient Information window. 2. Select a RigiScan Session and click View Details for Selected. 3. Click Print. 4.

  • Page 54: Treatment Summary Report

    ® (User Guide) 6.5 Treatment Summary Report Treatment Summary Reports list the information you entered in the Treatment Record window (see Patient Management in Chapter 3) for any number of patients. These reports cannot be displayed on the screen, but they can be printed out through the Reports window (see Reports in Chapter 3). The following fields appear on the Treatment Summary report: Patient ID.

  • Page 55: Base Data Report

    Session Number. This field displays session number for each patient. Session Duration. This field displays the duration of each session. Event Duration. This field displays the duration of all qualified events in the listed session. Event Percentage of Session. This field displays length of time for all qualified events in a session measured as a percentage of the total session duration.

  • Page 56: Chapter 7: Maintenance

    Should the loops or tension guides be bent or damaged, install new tension guide/cables prior to use. Do not use the monitor if the loops or tension guides/cables are damaged in any way. The RigiScan Plus Monitor may be cleaned and/or disinfected by wiping with a cloth moistened with a mild detergent solution or alcohol.

  • Page 57: Glossary

    Glossary Ambulatory. The activity of using the RigiScan Plus Monitor to collect data when it is independent of the PC. Baseline Tumescence. The estimated circumference of the penis in the resting, or flaccid, non-erect condition. Characterization Session. The first session of recording performed after the RigiScan Monitor has been initialized.
  • Page 58 Real-time. The output of data on the computer screen as the RigiScan Plus Monitor collects it. This can be done in both the nocturnal and provocative modes.
  • Page 59 minutes, monitoring will resume in the same session when the monitor is turned back on. If the moni- tor is turned off for more than fifteen minutes, it will begin the next session when it is turned on again. Tension Guides. Extensions which connect the penile loops to the RigiScan Monitor. Tumescence.

  • Page 60: Appendix A: Product Specifications Physical Dimensions

    ® (User Guide) Appendix A: Product Specifications Physical Dimensions -60-...

  • Page 61: Appendix B: Patient Instructions

    Appendix B: Patient Instructions The following pages lists instructions for the patient to follow in the use of the RigiScan Plus Monitor. Provide these instructions in order to send home with patients. WARNING: It is the responsibility of the physician to assure that adequate instructions and orientation regarding in-home use of the RigiScan Plus Monitor are given to the patient.
  • Page 62 The loops will squeeze gently around your penis every 15 seconds and will continue through the full session (up to ten hours). This is how the RigiScan Plus Monitor measures your erections. You may wear loose pajamas over the RigiScan Plus Monitor, however, be careful not to kink or bend the cables sharply.
  • Page 63 RigiScan Plus Monitor. You can leave the monitor off for up to fifteen minutes. Be sure to hold the leg strap and monitor in place when standing or walking. When you are ready to go back to sleep, turn the monitor on again.
  • Page 64 ® (User Guide) When you Wake the Next Morning When you wake the next morning first turn off the RigiScan Plus Monitor. Ease the loops off your penis by gently inserting your fingers into Fig. B-6 Replacing the the loops and pulling slightly outward to widen them.

  • Page 65: Appendix C: References

    Appendix C: References 1. Frohrib DA, Goldstein I, Payton TR, Padma-Nathan H, Krane RJ : Characterization of penile erectile states using external computer-based monitoring. J. Biomedical Engineering 1987, Mai, 109, p 110. 2. Kaneko S, Bradley WE : Evaluation of erectile dysfunction with continuous monitoring of penile rigidity.

  • Page 66: Appendix D: Electromagnetic Declaration

    ® (User Guide) Appendix D: Electromagnetic Declaration Notes and Cautions This symbol means: Attention, consult accompanying documents. This symbol indicates Type BF equipment. CAUTIONS: This device is not intended for use in the presence of flammable mixtures. This device requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents.
  • Page 67 Guidance and manufacturer’s declaration - electromagnetic emissions The RigiScan is intended for use in the electromagnetic environment specified below. The customer or the user of the RigiScan should assure that it is used in such an environment. Emissions Compliance Electromagnetic environment — guidance Test The RigiScan uses RF energy only for its internal function.
  • Page 68 ® (User Guide) Guidance and manufacturer’s declaration - electromagnetic immunity The RigiScan is intended for use in the electromagnetic environment specified below. The customer or the user of the RigiScan should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic environment...
  • Page 69 Recommended separation distances between portable and mobile RF communications equipment and the RigiScan The RigiScan is intended for use in an electromagnetic environment in which radiated RF disturbances are con- trolled. The customer or the user of the RigiScan can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RigiScan as recommended below, according to the maximum output power of the communications equipment.

  • Page 70: Appendix E: Rigiscan Nomogram

    ® (User Guide) Appendix E: RigiScan Nomogram -70-...

  • Page 71: Appendix F: Limited Warranty

    RigiScan Plus System from GOTOP Medical , Inc. This is limited warranty assured the CUSTOMER the GOTOP Medical, Inc. will replace or repair any RigiScan System which malfunctions in the course of normal operations within one year from the date of invoice due to defects in parts or workmanship.
  • Page 72 ® (User Guide) NOTES: -72-...
  • Page 73 -73-...
  • Page 74 It may not be reproduced in whole or in part without written permission from the publisher. Adaptation or any other form of copyright infringement by any individual, firm, organization or other entity will not be tolerated by the publisher of this work. U.S.A. Copyright ©2016 by GOTOP Medical, Inc. Printed in the United States of America P 651.641.3621 F 651.641.3622 www.gotopmedical.com...

Table of Contents