Instructions For Use - Cogentix Medical Urgent PC Mode D'emploi

INSTRUCTIONS FOR USE

This therapy, percutaneous tibial nerve stimulation (PTNS), involves
placing the Needle Electrode into the lower, inner aspect of either leg
slightly cephalad to the medial malleolus. A Surface Electrode is placed
over the medial aspect of the calcaneous on the same leg. The Lead
Wire is first connected to the Stimulator, and then the Needle Electrode
Clip is connected to the Needle Electrode. The Stimulator produces an
adjustable electrical pulse that travels to the sacral nerve plexus via the
tibial nerve. Among other functions, the sacral nerve plexus regulates
bladder and pelvic floor function.
The patient is typically treated once per week for 30 minutes for a period
of 12 weeks. No decision to discontinue treatment should be made until
the patient completes the 12 treatments. For patients responding to
treatment, the time between treatment sessions may be slowly increased
after the initial 12 treatments, with the patient closely monitored for the
return of symptoms. If symptoms reappear or increase in severity, the
patient's treatment schedule should revert to the last previously effective
treatment schedule.
TREATMENT PROTOCOL FOR EACH TREATMENT SESSION
1. Check Battery Level
» Before beginning any treatment session, it is advisable to
check the battery level. To check the battery level, turn on
the Stimulator by pressing and holding the Power Button for
approximately 2 seconds. An audible tone will sound and icons
will appear on the screen. Battery replacement is recommended
when there is only one line remaining in the Battery Level icon.
To conserve battery power, the Stimulator may be turned off
during patient preparation.
Note: The system is designed to prohibit the start of Test mode
if there is insufficient battery life remaining to complete the
treatment.
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2. Insert the Needle Electrode
» Locate the insertion site for the Needle
» To prepare the Needle Electrode insertion site, open the Lead
Set packaging. Remove and open the Alcohol Pad. Use the
Alcohol Pad to clean the skin area surrounding the identified
insertion site.
» Place the patient in a comfortable position, supine or sitting, for
easy access to the insertion site; for example, the patient may
sit with the soles of the feet together and knees abducted and
flexed. Open the sterile Needle Electrode package and remove
the Needle Electrode/guide tube assembly.
» Place the Needle Electrode/guide tube assembly over the
identified and cleaned insertion site in a position that creates a
60-degree angle between the Needle Electrode and the ankle.
Remove the stop plug in the guide tube to release the Needle
Electrode.
» Gently tap the Needle Electrode head to pierce the skin. Once
the Needle Electrode has penetrated the skin, remove the guide
tube and advance the Needle Electrode
using a rotating motion to facilitate entry.
Note: it is important to maintain a 60-degree
angle with the Needle Electrode while
advancing it in a path that is parallel to the
tibia. When appropriately inserted,
approximately 2 cm (¾") of the Needle
Electrode will be inserted in the leg.
Electrode by identifying the location on
the lower inner aspect of either leg that
is approximately three fingerbreadths
(5 cm or 2") cephalad to the medial
malleolus and approximately one
fingerbreadth (2 cm or ¾") posterior to
the tibia.
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