Status Screen
Icons and alpha-numeric characters on the Status Screen provide
operational feedback. These include:
Battery Level icon
The number of horizontal lines displayed in the Battery Level
icon represents the remaining battery life. Seven horizontal
lines indicate a fully charged battery whereas one horizontal line
indicates that the battery is nearly empty. A flashing Battery Level
icon signals that a replacement battery is needed. In addition, the
Stimulator will emit a beep every 15 seconds when the battery is
nearly empty (only one line displayed in the Battery Level icon).
Note: The system is designed to prohibit the start of Test mode
if there is insufficient battery life remaining to complete the
treatment.
Lead Wire Status icon
Indicates the functional status of the Lead Wire. The icon will flash
if a new Lead Wire is required.
Inactive Current icon
Indicates that current is not flowing through the Lead Set. Check
the security of the Lead Connector, the adherence of the Surface
Electrode, and the placement of the Needle Electrode Clip.
Active Current icon
Indicates that current is actively flowing through the Lead Set.
Service Required icon
If a fault is detected, Therapy mode will end and the Service
Required icon will appear on the screen. Contact Cogentix Medical
for further instructions.
Note: Holding down more than one button at start-up may result
in the Service Required icon appearing on the display. If this icon
appears at start-up, use the Power button to turn the device off
and on.
10
Treatment Status (Lower right of screen)
During Test Mode, the word "TEST" will appear on the screen.
Once Therapy mode is started, a countdown timer will appear in
the lower right of the display. This timer indicates how much time
is left in the 30 minute Therapy session.
Upon completion of Therapy, the word "END" will flash on the
screen until shutdown.
Current Setting (Center of screen)
The selected current setting is displayed at all times in the center
of the status screen. The current is adjustable in both Test and
Therapy modes.
Urgent PC Lead Set
The Lead Set transfers the electrical current from the Stimulator to the
tibial nerve and includes:
» Lead Wire: the components of the Lead Wire create the non-sterile
circuit interface between the Simulator and the patient. A one-way
fit Stimulator connector is attached to the proximal end of the Lead
Wire. The distal end of the Lead Wire is split into individual wires.
One wire is attached to an adhesive-backed Surface Electrode; the
other is attached to the Needle Electrode Clip.
» Needle Electrodes: two 34 Ga. solid stainless steel Needle
Electrodes, each contained within a plastic guide tube with stop plug.
Each Needle Electrode is supplied sterile in an individual peel-open
package.
» Alcohol Pad: a prepackaged alcohol pad to clean the Needle
Electrode insertion site.
11