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Gotop RigiScan Plus, Руководство пользователя

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Contraindications

•  Not for use in evaluating erectile capability in children.

•  Do not use the RigiScan Plus Monitor in men who have communicable skin or venereal dis-

eases or men who have any rash or lesions on the penis or surrounding area.

•  Do not use in men with impaired mental capacity unless the testing period is directly super-

vised by appropriate medical personnel.

Chapter 1: Introduction

The RigiScan Plus System allows you to measure the duration, frequency, and degree of rigidity and 
tumescence of the penis. This device provides a graphical and tabular display of base and tip penile 
rigidity and tumescence data for the physician’s interpretation. The design of the RigiScan Plus System 
makes it simple for you and your patients to use, yet it offers a sophisticated range of capabilities and 
applications. The system is suitable for nocturnal data collection or data collection during various 
provocative interventions that are intended 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 information which must be observed to ensure patient safety and 
proper operation of the RigiScan Plus system.

Warnings

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.

•  DO NOT use the RigiScan Plus Monitor with improperly or incompletely installed tension 

guides. The tension guides must be inserted in the monitor with the tension guide pin fully 
seated in the slot on the top of the housing. Use of a RigiScan Plus with improperly inserted 
tension guides may result in patient injury.

•  DO NOT operate the RigiScan Plus Monitor near sources of intense pulsed or conducted 

electrical or magnetic fields such as Magnetic Resonance Imaging (MRI), CT scan, X-ray, 

Содержание RigiScan Plus

Страница 1: ...User Guide CAUTION Federal USA law restricts this device to sale by or on the order of a physician...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 72: ...72 RIGISCAN User Guide NOTES...

Страница 73: ...73...

Страница 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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