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Gotop RigiScan PLUS User Manual

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User Guide
for Generation 4 Systems

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Summary of Contents for Gotop RigiScan PLUS

  • Page 1 User Guide for Generation 4 Systems...

  • Page 2: Table Of Contents

    Chapter 4: Preparing the RigiScan Plus System for Patient Testing ......

  • Page 3: Chapter 1: Introduction

    7.1 Instructions for Disinfecting the RigiScan Plus Monitor ....... .62...

  • Page 4: Principles Of Operation

    The RigiScan Monitor then takes a tumescence measurement. After the • Do not attempt to modify the RigiScan. GOTOP Medical Inc. can not be held responsible tumescence measurement is taken, it is compared to the previous samples. When a 6 mm increase in...

  • Page 5: The Rigiscan Plus Monitoring System

    PLUS ® (User Guide) Chapter 2: Setting Up the RigiScan Plus System 1.3 The RigiScan Plus Monitoring System 2.1 System Requirements A new RigiScan System consists of the following components and accessories: • RigiScan Monitor • RigiScan Windows Software Before you can install the RigiScan Software, you must assemble the following hardware •...

  • Page 6: Connecting The Event Marker (Optional)

    You can use the optional Event Marker to mark pertinent points in the patient data. agreement set forth by GOTOP. To do so, click the radio button next to “I agree with the above terms and conditions”. Then click Next.

  • Page 7: Chapter 3: Software Operation

    Enter the name of the business or individual to whom the software is licensed, then click Save. If you don’t have a “Devices.adl” file, contact GOTOP customer service for one via the “contact us” tab on the www.gotopmedical.com website or via email: info@gotopmedical.com If outside of the United States, contact your local GOTOP customer service representative.

  • Page 8: The Rigiscan Plus Home Screen

    PLUS ® (User Guide) 3.2 The RigiScan Plus Home Screen 3.3 RigiScan Control Window When you start the RigiScan Software, the RigiScan Home Screen will appear in a new window. Clicking the RigiScan button on the RigiScan Home Screen opens the RigiScan Control window.
  • Page 9 (typically C:\GOTOP\Rigiscan\) and verify that the connected Email:info@gotopmedical.com or device has been registered for use on this PC with GOTOP. See Section 2.4 for installation and regis- TEL: 651-641-3621 tration details. If problem persists, contact GOTOP customer service at 1-651-641-3621, via the “contact us”...

  • Page 10: Initializing The Monitor

    ® (User Guide) To Start Monitoring Session: Using the RigiScan Plus - Initializing the Monitor See Chapter 5: Patient Testing for details on starting Real-Time and Ambulatory Monitoring Sessions. To Initialize the Device (New Patient): 1. Click the Initialize Device button in the RigiScan Control window. This opens the Device Ini- To Download Patient Data (following a monitoring session): 1.

  • Page 11: Patient Management Window

    3.4 Patient Management Window To view all patients who visited on or after a specific day: Clicking the Patient Mgmt button on the RigiScan Plus Home Screen opens the Patient Management 1. Click the Recently Visited button. window. Here, the user may add, view, edit, delete, import, and export patient records.
  • Page 12 PLUS ® (User Guide) To Add A New Patient (Manual Entry): To Import a New Patient From File: 1. Click the to open the Patient Information window. 1. Click the button to open the Patient Information window. 2. Fill in pertinent patient information on the General tab. 2.
  • Page 13 Information window. History, and RigiScan tabs. Double-click the Patient ID of the record you wish to edit to open the Patient Information To View Existing RigiScan Plus Monitoring Data: 1. Navigate to the RigiScan tab in the Patient Information window. window.
  • Page 14 PLUS ® (User Guide) Exporting Patient Data into a CSV File The following information is included when exporting patient data into a CSV file: • Physician • Patient ID • Date • Test Method • Sample Number • Sample Time •...

  • Page 15: Report Manager Window

    1. Selecting the Show Selection Info from the context menu displays a pop-up giving you more information. 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.

  • Page 16: Filtering Available Patients

    Pressing the Cancel button closes the Report Selector window. For details on the information provided in each report, see Chapter 6: RigiScan Plus Reports. Clicking Apply Filters will bring the user back to the Report Manager window, where only those patients meeting the filter criteria will be shown in the Available Patients area.

  • Page 17: Data Management Window

    1. To avoid inadvertent loss of data, it is recommended to always backup the current database prior Clicking the Data Mgmt button on the RigiScan Plus Home Screen opens the Data Management to using the Restore feature. The Restore feature completely overwrites the current database.
  • Page 18 2. From this window, the user may select patient records to archive or un-archive (set as active). 2. Click the DB Clean Up button. 3. Clicking the button closes the Archive Manager window and re-opens the RigiScan Plus 3. When prompted, select the “Delete Before:” date. All patient treatment history prior to the select- Home Screen.

  • Page 19: Rigiscan Settings Window

    2. When prompted in the Date Selection pop-up window, select the archive cutoff date. 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 application for their particular needs.
  • Page 20 PLUS ® (User Guide) Other Settings: COM Port Selection: Select the COM port that corresponds with the desired RigiScan. They are identified as “COM#” Auto Print Graphs (feature currently disabled): where the # is a number assigned by the Windows operating system. This option allows the automatic printing of the Rigi Session Graphs once the downloading of session data is complete.

  • Page 21: Rx Codes Tab

    4. Click the button in the upper right corner to save changes and return to the RigiScan Plus 4. Click the button in the upper right corner to save changes and return to the RigiScan Plus Home Screen.

  • Page 22: 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 23: Chapter 4: Preparing The Rigiscan Plus System For Patient Testing

    4.1 Initialize the RigiScan Monitor for the Patient to be Tested See subsection “Using the RigiScan Plus - Initializing the Monitor” on page 18 inside Chapter 3.3 called “RigiScan Control Window”. Please note that the RigiScan will only record up to 3 sessions.

  • Page 24: Removing The Tension Guides

    PLUS ® (User Guide) 5. If the end of the Tension Guide appears like Figure 4-2, the loop has not been fully expanded. 4.3 Removing the Tension Guides It should look like Figure 4-3. 1. Verify that the RigiScan monitor is turned off, batteries are removed, and USB disconnected. 2.

  • Page 25: Installing The Loop Covers

    RigiScan monitor begin to blink, that signals that the batteries don’t have enough power to record another full 10-hour session. Fig. 4-8 NOTE: The RigiScan monitor’s internal lithium battery must be replaced by a qualified GOTOP Medical service technician a minimum of one (1) time per year. -48-...

  • Page 26: Chapter 5: Patient Testing

    This method of testing is performed over a shorter period of time, usually in using GOTOP approved rechargeable batteries, place them in GOTOP approved battery charger an office setting. Intervention might include the injection of a pharmacological agent or visual sexual and allow them to fully charge before re-use.

  • Page 27: Removing The Loops Quickly

    PLUS ® (User Guide) Removing the Loops Quickly 5.3 Testing Patients Using the Real-time and Ambulatory Modes Normally the patient would remove the loops by first turning the RigiScan instrument off and then inserting his fingers gently into the loops and pull- Real-time Testing ing outward to expand the loops.

  • Page 28: Time Monitoring

    Chapter 3.) 5. Click to return to the RigiScan Plus Home Screen. 7. Click the Real Time Monitoring button. If you initialized the patient data for provocative testing, the Provocative Real-time Mode Graphs screen will appear. Otherwise, the Nocturnal Real-time 6.

  • Page 29: Beep Cues

    PLUS ® (User Guide) Chapter 6: RigiScan Plus Reports Beep Cues 6.1 The Session Scan Summary Report Each time the patient turns the RigiScan 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. The buzzer is not loud. It is located within the The RigiScan Session Scan Summary Report allows you to see the results of previously downloaded case, in the lower right corner of the RigiScan.

  • Page 30: The Summary Analysis Statistic Report

    PLUS ® (User Guide) 6.3 Printing Session Scan Summary and Summary Analysis Statistics Reports 6.2 The Summary Analysis Statistic Report To Print the Session Scan Summary Report: The RigiScan Summary Analysis Statistics Report provides a comprehensive review of the duration of events, their averages, and baselines.

  • Page 31: Treatment Summary Report

    PLUS ® (User Guide) 6.5 Treatment Summary Report Session Number. This field displays session number for each patient. Session Duration. This field displays the duration of each session. Treatment Summary Reports list the information you entered in the Treatment Record window (see Patient Management in Chapter 3) for any number of patients.

  • Page 32: Chapter 7: Rigiscan Plus Cleaning And Disinfection

    Red LED inside the battery compartment, is illuminated, contact 1. Remove and discard all loop covers that are attached to the RigiScan monitor or included in the GOTOP Medical Customer Service. The lithium battery limits the shelf life of the RigiScan monitor to carrying case.

  • Page 33: Glossary

    PLUS ® (User Guide) Glossary Nocturnal Mode. A testing mode conducted at night while the patient sleeps. This mode uses the Ambulatory. The activity of using the RigiScan monitor to collect data when it is independent of the entire session to calculate a baseline for evaluation. Provocative Mode.
  • Page 34 PLUS ® (User Guide) Session. A monitoring period between fifteen minutes and ten hours in length. The RigiScan monitor will store the data from three sessions and one Characterization Session in its memory. The RigiScan monitor may be intermittently turned off for periods of up to fifteen minutes to allow time for the patient to urinate.

  • Page 35: Appendix A: Product Specifications

    Warning! DO NOT turn on the RigiScan monitor until you have placed the loops on your Class II Medical Equipment penis. Doing so may result in penile pain, irritation or bruising. Two GOTOP Approved Warning! DO NOT remove or loosen cables from the RigiScan monitor. If the cables are Rechargeable 9V Batteries...
  • Page 36 ® (User Guide) Placing the RigiScan Plus Monitor into Protective Bag The flap needs to be cut so each side can fold around the two tension guides coming out from the top Slide the RigiScan monitor in the protective bag so that the resealable flap is on the back of the RigiScan.
  • Page 37 Fig. B-9A 2. With one hand, grasp the loop at the “Y” connector. Starting a RigiScan Plus Session 3. With the other hand, grasp the quick release tab and pull it sharply until the two ends of the loops come apart.

  • Page 38: Appendix C: Troubleshooting Guide

    RigiScan monitor, but rather in the devices.adl file corresponding to the unit. When a RigiScan is calibrated by GOTOP Medical, a new devices file is supplied. That file needs to replace the old devices file in the same folder as the RigiScan program.

  • Page 39: Appendix D: References

    Red LED is on? If the red LED in the 9V battery box is on, the internal Lithium battery is low and needs 5. Kessler WO : Nocturnal penile tumescence. Urologic Clinics of North Am. 1988, Feb., 15(1), to be replaced. Contact GOTOP Customer Service. p 81.

  • Page 40: Appendix E: Electromagnetic Declaration

    (User Guide) Guidance and manufacturer’s declaration - electromagnetic emissions The RigiScan Plus is intended for use in the electromagnetic environment specified below. The customer or the user Appendix E: Electromagnetic Declaration of the RigiScan Plus should assure that it is used in such an environment.

  • Page 41: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RigiScan Plus is used exceeds the applicable RF compliance level above, the RigiScan Plus should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RigiScan Plus.

  • Page 42: Appendix F: Rigiscan Plus Nomogram

    Upon determination of the nature and cause of the malfunction, GOTOP Medical, Inc. will issue a “no charge” invoice for services and parts covered by the warranty. Charges not covered by warranty will be invoiced to the purchaser at the GOTOP Medical, Inc.
  • Page 43 PLUS ® (User Guide) NOTES: - This page intentionally left blank - -84- -85-...
  • Page 44 GOTOP Medical, Inc., 1000 Westgate Drive, Suite 125, Copyright ©2024 by GOTOP Medical, Inc. Printed in the United States of America St. Paul, MN 55114 U.S.A.

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