Troubleshooting Guide
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Urgent® PC Treatment Trouble-shooting Guide Consult the Instructions for Use and Urgent PC training for detailed information on the use of the Urgent PC Neuromodulation System.
Issue
Potential causes and solutions
Potential Causes: Stimulator not Lead Set is not new. A fuse within the Lead Set prevents it from being used recognizing Lead Set more than once. at Start-up Lead Set is not inserted correctly. Lead set is faulty. Corrective Action Steps: 1. Power off Stimulator. Make sure the Lead Set is fully inserted into the Stimulator. Power Stimulator back on. 2. If this doesn’t work, power off Stimulator. Disconnect Lead Set from Stimulator and reinsert. Power Stimulator back on. 3. If this doesn’t work, restart process with a new Lead Set. 4. If a new Lead Set does not resolve the issue, contact Cogentix Medical Customer Care.
Stimulator stopped mid-treatment
Potential Causes: The patient moved their leg. Movement may disrupt the electrical circuit. The Stimulator recognizes an incomplete circuit and treatment ceases immediately. The STOP button was pressed. Stimulator was not transferred out of TEST mode into THERAPY mode. Corrective Action Steps: 1. If Stimulator stops during TEST mode: Restart TEST mode with current Lead Set. 2. If Stimulator stops during THERAPY mode: <1 minute in THERAPY mode, restart TEST mode with current Lead Set.
Unable to insert Lead Set
>1 minute in THERAPY mode, you will need a new Lead Set.
Potential Causes: Something is stuck in the pin area of the connector guide. You have an older device. Older devices may not contain a connector guide to assist in the alignment of the lead set into the stimulator. Without this connector guide, the pins are prone to bend. The glue holding the connector guide may have failed. Corrective Action Step: 1. Contact Cogentix Medical Customer Care.
Current will not exceed level #4
Potential Causes: There is an incomplete electrical circuit. The Lead Set wires have been separated by the user. Pulling wires apart too far or too quickly may damage internal wiring. Corrective Action Steps: 1. Make sure the surface electrode is properly adhered on the bottom of the foot. Clean and dry area prior to electrode placement. 2. Check the placement of the Needle Electrode. Angle: 60 degrees, pointed towards head Depth: ~¾” (half of bottom portion) inserted Near tibial nerve: 3 fingers from ankle bone, 1 finger behind tibia 3. Check the connection of the electrode clip onto the needle electrode. 4. If this does not resolve the issue, restart treatment. A new Lead Set may be required if you have entered TEST mode 5 times or have been in THERAPY mode for more than 1 minute.
Potential Causes: Service icon appears Pressing multiple buttons at one time may produce a false error. Internal error within Stimulator. Corrective Action Steps: 1. Restart setup for treatment, taking each step at a slower pace. 2. If this does not resolve the issue, contact Cogentix Medical Customer Care. Stimulator will not power on
Potential Causes: Power button wasn’t held down long enough. The Power button is a press and hold button. The Stimulator doesn’t have sufficient battery power. Corrective Action Steps: 1. Hold for 2 seconds, listen for auditory signal. 2. Make sure the battery has a sufficient charge to operate the stimulator. 3. Ensure the battery is installed in the correct orientation. 4. If this does not resolve the issue, contact Cogentix Medical Customer Care.
Potential Cause: Stimulator will not go The button wasn’t held down long enough. The buttons for initiating TEST and into THERAPY mode are press and hold buttons.
TEST or THERAPY
Rattle in Stimulator
Corrective Action Steps: 1. Hold button for at least 2 seconds, taking care to only press one button at a time. 2. Listen for auditory signal. Potential Cause: The glue holding the connector guide may have failed. Corrective Action Step: 1. Contact Cogentix Medical Customer Care.
For treatment-related questions, contact your area manager or Cogentix Medical Customer Care at 866.258.2182 Urgent PC is indicated for the treatment of Overactive Bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence. Contraindications: patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or patients who are pregnant or planning to become pregnant during the duration of the treatment. Precautions: Exercise caution for patients with heart problems related to pacing. Most patients don't experience side-effects. If side-effects occur, they are typically temporary and include mild pain and skin inflammation at or near the stimulation site. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For complete instructions for use, storage, warnings, indications, contraindications, precautions, adverse reactions and disclaimer of warranties, please refer to the insert accompanying each product or online at www.cogentixmedical.com. Urgent is a registered trademark of Cogentix Medical, Inc. © 2015 All rights reserved. 20310C 10/15
Cogentix Medical, Inc. 5420 Feltl Road Minnetonka, MN 55343 USA TOLL FREE 866 258 2182 FAX 952 426 6199 WWW cogentixmedical.com