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Principles of Operation

The RigiScan® Plus Monitor is an ambulatory data logging unit that measures and records penile rigidity and tumescence. It is linked by cable to an IBM-compatible computer, which downloads and processes the data, stores it for review, and prints it on command. The ambulatory monitor uses tip and base penile loops that adjust by tightening slightly at discrete time intervals to measure and record penile rigidity and tumescence. Each loop contains a cable that moves freely inside a conduit. Each loop takes a measurement every 15 seconds. The loop gently tightens with a linear force of 4 ounces (114g) and then immediately releases and the tissue rebounds to its unloaded state. The RigiScan® Plus Monitor then takes a tumescence measurement. After the tumescence measurement is taken, it is compared to the previous samples. When a 6 mm increase in tumescence is detected, representing possible erectile activity, the RigiScan® Plus Monitor takes a second measurement every 30 seconds. After tumescence is measured, the loops tighten a second time around the circumference of the penis with a linear force of 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.

Real-time Monitoring

One of the options on the RigiScan® Contents screen is RTM (Real-time Monitoring). Real-time Monitoring is useful for collecting rigidity and tumescence data for immediate analysis, which can be done in the privacy

of your office or the sleep laboratory. At the same time the RigiScan® Plus Monitor is storing the patient’s data, you can view it on your computer screen. Real-time Monitoring can be performed in the Provocative or Nocturnal mode. If you select the provocative method of testing during initialization, and then click RTM, the Provocative Real-time Mode Graphs screen will open.

 

NOTE: Place the RigiScan® Plus Loops on the patient’s penis before

you click RTM.

Mode Graphs Display

Base rigidity and tip rigidity are expressed on the left margin of the graph as percentages ranging from 0% to 100%. Base tumescence and tip tumescence are expressed in centimeters, ranging from 5 cm to 15 cm, to measure the circumference of the penis. As the RigiScan® Plus Monitor collects data, the current value is updated on the right margin of the graph. Place the RigiScan® Plus Monitor Loops on the patient’s penis before you click RTM.

Nocturnal & Provocative Collection Modes

Estimating an appropriate baseline for penile circumference is an important parameter in the processing of rigidity and tumescence data by the RigiScan® Plus System Software. There are two different modes of data collection: Nocturnal and Provocative. Each method processes data differently in order to establish an accurate estimate of the baseline penile

circumference, so it is important to select the appropriate mode during initialization before you begin testing the patient.

Nocturnal Testing

You should use the Nocturnal Testing mode when you want to monitor nocturnal erections over a period 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 Mode is used when there are multiple erectile events and there is a periodic return to the flaccid state. This uses the entire session to calculate the

baseline.

Provocative Testing

Provocative Testing is performed when the clinician wants to use an intervention to produce a one-time erectile response. This method of testing is performed over a shorter period of time, usually in an office setting. Intervention might include the injection of a pharmacological agent or visual sexual stimuli. This test method can also be used under either Ambulatory or Realtime settings. In the Provocative Mode, the RigiScan® Plus System records a baseline penile tumescence during the first fifteen minutes of testing and stores it for later reference. If you are testing in the Real-time mode, the message CALCULATING BASELINE will flash at the bottom of the screen while the baseline tumescence is being established. Only when the message BASELINE ESTABLISHED appears on the screen indicating the baseline tumescence is calculated and stored may intervention be given to the patient. If you are testing in the ambulatory mode, monitoring must be performed for a period of fifteen minutes to establish a baseline value before intervention is given to the patient.

Testing Patients Using the Real-time

& Ambulatory Modes

Real-time Testing

Real-time Monitoring permits the clinician to view data recorded during sessions immediately on the computer screen. Either Nocturnal or Provocative testing can be performed using the Real-time Monitoring Option. Battery life during RTM is approximately three hours.

Ambulatory Testing

Ambulatory monitoring allows the RigiScan® Plus Monitor to collect data without being connected to the computer. At home, the patient is responsible for placing the loops on his penis correctly, and for replacing the two 9-volt batteries before each nocturnal session. To collect patient data in the ambulatory mode, follow these steps in the exact order given.

RigiScan® is the registered trademark of GOTOP Medical, Inc.,   Copyright 2014 GOTOP Medical, Inc. All Rights Reserved.