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Gotop RigiScan Plus, User Manual

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1.3 The RigiScan Plus Monitoring System

The RigiScan Plus System consists of the following components and accessories:

 

• RigiScan Plus Monitor

 

• RigiScan Plus Program (USB)

 

• Carrying case

 

• Box of Leg straps

 

• Communications cable

 

• Event Marker cable (optional)

 

• RigiScan Plus User’s Manual

 

• Set of tension guides

 

• Box of loop covers

 

• Box of Duracell 9-volt Batteries

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.

R

IGI

S

CAN

®

   (

User Guide

)

Fig. 1-1

Summary of Contents for 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: ...soltanto il sistema di valutazione della rigidit RigiScan Plus della GOTOP Medical Tutti i diritti sono riservati Stampato negli USA Sono validi i brevetti statunitensi No 4 515 166 e 4 766 909 Este m...

Page 3: ...ager Window 25 Filtering Available Patients 26 Report Selector 27 3 6 Data Management Window 28 3 7 RigiScan Settings Window 33 General Tab 33 Rx Codes Tab 36 Drug Codes Tab 37 Prosthesis Codes Tab 38...

Page 4: ...n Scan Summary and Summary Analysis Statistics Reports 53 6 4 Patient Summary Report 53 6 5 Treatment Summary Report 54 6 6 General Session Info Report 54 6 7 Base Data Report 55 6 8 Tip Data Report 5...

Page 5: ...tended to produce an erectile response Testing may be conduct ed in a stand alone Ambulatory mode or in a Real time monitoring mode when connected to your computer This chapter contains important info...

Page 6: ...inuous rigidity sampling and may result in patient discomfort pain irritation or bruising The RigiScan Monitor must be turned off prior to urination The monitor may be turned off for a continuous peri...

Page 7: ...logging unit that measures and records penile rigidity and tumescence It is linked by cable to an IBM compatible computer which downloads and process es the data stores it for review and prints it on...

Page 8: ...cable Event Marker cable optional RigiScan Plus User s Manual Set of tension guides Box of loop covers Box of Duracell 9 volt Batteries Optional Accessories Rechargeable Batteries and Charger are ava...

Page 9: ...t 1 GB of random access memory RAM Available USB 2 0 port VGA compatible graphics card VGA monitor Mouse and keyboard Printer Supplied USB Flash Drive Note Windows DPI setting should be 100 for optimu...

Page 10: ...l 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 Ma...

Page 11: ...sh Drive and install driver if necessary 3 Use Windows Explorer to navigate to the Flash Drive s root directory 4 Double click the RigiScan Inst v5 03 exe excecutable file 5 When prompted click Next i...

Page 12: ...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...

Page 13: ...an icon on the desktop or 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...

Page 14: ...of buttons along with functional descriptions of each are provided RigiScan opens the RigiScan Control window see Section 3 3 Patient Mgmt opens the Patient Management window see Section 3 4 Reports...

Page 15: ...session initialize the device for a new patient or start a Real Time Monitoring session If clicking the RigiScan button on the RigiScan Plus Home screen opens the Error Communicating pop up window cl...

Page 16: ...m the Test Method drop down menu 9 Click OK to complete initialization and return to the RigiScan Control window To Initialize the Device Existing Patient 1 Click the Initialize Device button in the R...

Page 17: ...ice contains monitoring data not yet downloaded to the PC database the RigiScan Con trol window will display NOT Downloaded in the Download Status area 5 Click the Download Now button 6 A Data Downloa...

Page 18: ...as well as quick search but tons are available along the left side of the window To Search for an individual patient record 1 Type a patient ID number into the Patient ID text box 2 Click the Search b...

Page 19: ...atment Record pop up window 5 Use text entry fields and drop down menus to fill in the pertinent treatment history information 6 Click the button to save treatment record and return to the Patient Inf...

Page 20: ...dow or Double click the Patient ID of the record you wish to edit to open the Patient Information window 2 Modify fields in the General tab as necessary 3 Click the button to save patient record 4 In...

Page 21: ...view General Treatment History and RigiScan tabs ToView Existing RigiScan Monitoring Data 1 Navigate to the RigiScan tab in the Patient Information window 2 Click the RigiScan session you wish to view...

Page 22: ...on or return to the Session Scan Summary window using the button 5 From the Session Scan Summary window you can click the View SAS button to open the Session SASViewer window 6 From the Session SASVie...

Page 23: ...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 Also the Interval Time in the lower right corner will display how long...

Page 24: ...hat region from the Session SASViewer and Session Scan Summa ry screens A confirmation dialog box will appear before excluding any data 2 The excluded data can be restored by clicking the blue link in...

Page 25: ...ndow brings the user back to the RigiScan Plus Home Screen To add all available patients to the current report 1 Click Add ALL To remove all sected patients from the current report 1 Click Remove ALL...

Page 26: ...an Data Type It is here that the user may also clear previously applied filters to make all patients available again Clicking Apply Filters will bring the user back to the Report Manager window where...

Page 27: ...ser can select from the following report options Patient Summary Treatment Summary General Session Info Base Rigidity Info Tip Rigidity Info Clicking the Select button opens a print dialog box which a...

Page 28: ...a previous database cleanup the current database and specify patient records as active or archived status Clicking the button in the upper right corner of the Data Management Window brings the user b...

Page 29: ...ent 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 When prompted with the Warning...

Page 30: ...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 4 Click D...

Page 31: ...t record 1 Click the Patient ID of the desired record to archive 2 Optional Ctrl Click to select multiple patient records 3 Click the Archive Selected button 4 Click the button to save changes to pati...

Page 32: ...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 2 Optional C...

Page 33: ...r back to the RigiScan Plus Home Screen Below you will find a description of each tab available from the Settings Window General Tab The General Tab allows the user to select the correct serial port u...

Page 34: ...different RigiScan devices connected to the PC COM7 is an earlier generation RigiScan that uses the original Serial cable that requires an external power supply In this instance it is also using a Ser...

Page 35: ...l of data in the graphs 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 appea...

Page 36: ...reatment code 2 Click inside the Description text entry box and type the desired treatment description 3 Click the button to add the new treatment code and description 4 Click the button in the upper...

Page 37: ...code 2 Click inside the Description text entry box and type the desired drug description 3 Click the button to add the new drug code and description 4 Click the button in the upper right corner to sav...

Page 38: ...prosthesis code 2 Click inside the Description text entry box and type the desired prosthesis description 3 Click the button to add the new prosthesis code and description 4 Click the button in the u...

Page 39: ...uct information including Application Name ApplicationVersion Application Release Date GOTOP Medical Contact Information Product Registration Information It also allows the user to change to whom the...

Page 40: ...rds the boot of theTension Guide and the loop fully expanded 4 Hold theTension Guide by the boot at the ball end of the cable and insert it into the correspond ingTension Guide housing on the Monitor...

Page 41: ...gure 4 2 Fig 4 1 Installing the Tension Guides Fig 4 2 Expanding the Loops CAUTION DO NOT over tighten the retention nuts as this will make future removal very difficult CAUTION Turn the RigiScan Moni...

Page 42: ...gently pull the feeder tube and cable through the loop cover until the Y connect is adjacent to the threaded end of theTension Guide 3 Hold theTension Guide boot in one hand the Y connect in the oth e...

Page 43: ...uses either two DURACELL 9 volt alkaline batteries or two GOTOP approved rechargeable 9 volt batteries They must either be replaced or have been fully recharged if using GOTOP approved rechargeable b...

Page 44: ...ap the leg strap supplied in the carrying case around the thigh of either leg with the opening pointing toward the patient s penis see Figure 4 6 If the patient sleeps on his left side you should atta...

Page 45: ...ons over a peri od of several hours This test method can be used while the patient is at home or in a sleep laboratory setting and also can be used under Ambulatory or Real time settings The Nocturnal...

Page 46: ...erting his fingers gently into the loops and pulling outward to expand the loops How ever if the patient experiences pain during testing or wants to remove the loops quickly for any other reason he ca...

Page 47: ...ition it at the base of the penis Second fit theTIP Loop white boot over the patient s penis and position it at the tip of the penis just below the glans WARNING It is IMPORTANT to follow the instruct...

Page 48: ...RigiScan Plus Monitor s power 11 Remove the loops from the patient s penis 12 Download the patient s data to the computer SeeTo Download Patient Data in Chapter 3 Ambulatory Testing Ambulatory monitor...

Page 49: ...BASE Loop blue boot over the patient s penis and position it at the base of the penis Second fit theTIP Loop white boot over the patient s penis and position it at the tip of the penis just below the...

Page 50: ...tion allowed for characterization is fifteen minutes If the monitor is left on for a period exceeding fifteen minutes during the Characterization Session it will automatically start to record session...

Page 51: ...subsequent sessions Date This field displays the date start and stop times and the duration of each session Number of Events This field displays the total number of qualified events recorded during e...

Page 52: ...as at a certain percent level of rigidity This report is valid for individual sessions as well as a composite view Baseline Circumference This field shows the baseline or non tumesced circumference Av...

Page 53: ...ny number of patients These reports cannot be displayed on screen but they can be printed through the Reports window see Reports in Chapter 3 The following fields appear on the Patient Summary Report...

Page 54: ...you entered for the date displayed in Visit Date field The legend of codes for these fields appears on the last page of the report Cavernosography Code This field displays the test results entered fo...

Page 55: ...or base and tip data The RAU value rep resents the area under the rigidity curve during an event The TAU value represents the area under the tumescence curve based on the percent increase in tumescenc...

Page 56: ...an Plus Monitor may be cleaned and or disinfected by wiping with a cloth moistened with a mild detergent solution or alcohol The internal lithium battery must be changed by a qualified GOTOP Medical S...

Page 57: ...ient is using the device properly at home After monitoring is completed and the data has been downloaded the Characterization Session graph can be printed or viewed through the Patient Information win...

Page 58: ...idity as a per centage Rigidity Activity Units RAU This value is a time intensity measurement that represents the area under the rigidity curve during a qualified event The Rigidity Activity Unit is c...

Page 59: ...e of the penis measured in centimeters Tumescence Activity Units TAU This value is a time intensity measurement that represents the area under the tumescence curve above the baseline during qualified...

Page 60: ...60 Appendix A Product Specifications Physical Dimensions RIGISCAN User Guide...

Page 61: ...tor on may cause pain irritation or blood in the urine Warning DO NOT use electric blankets electric razors power tools microwave ovens hair dryers or cellular phones while operating the RigiScan Plus...

Page 62: ...giScan Plus Monitor press the on off button until it clicks and pops out see Figure B 4 The RigiS can Plus Monitor will beep once when activated the first night twice the second night and three times...

Page 63: ...rience pain during testing or want to remove the loops quickly for any other reason you can unsnap the loops with the quick release tab To do this follow these steps see Figures B 5A and B 5B 1 With o...

Page 64: ...y ing case REMEMBER If you have any questions do not hesitate to contact your doctor s office Replace recharge the batteries before each evening s session If using alkaline batteries fresh batteries a...

Page 65: ...erapy in postpriapism cavernosal fibrosis J Urology 1988 Oct 140 p 828 7 Weinberg JJ Badlani GH Utility of RigiScan and papaverine in diagnosis of erectile impotence J Urology 1988 Juin 31 6 p 526 8 Z...

Page 66: ...quipment and that if adjacent or stacked use is necessary the RigiScan should be observed to verify normal operation NOTE ON CLASSIFICATION This device is classified as internally powered This device...

Page 67: ...50 60 Hz magnetic field IEC 61000 4 8 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 6 kV contact 8 kV air 3 A m 3 A m 2 kV for...

Page 68: ...V m 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...

Page 69: ...stance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 0 01 0 1 1 10 100 0 12m 0 38m 1 2m 3 8m 12m 0 12m 0 38m 1 2m 3 8m 12m 0 23m 0 76m 2 3m 7 6m 23m 80 MHz to 800 MHz d 1 2 P 800 M...

Page 70: ...70 RIGISCAN User Guide Appendix E RigiScan Nomogram...

Page 71: ...USE OF THIS SYSTEM OR THE INTERPRETATION OF THE DATA CAUSED BY ANY FAILURE OR MALFUNCTION OF THE PRODUCT To qualify for the remedy provided by this limited warranty the CUSTOMER must meet the followi...

Page 72: ...72 RIGISCAN User Guide NOTES...

Page 73: ...73...

Page 74: ...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 Copyright 2016 by GOTOP Medica...

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