Description Of Symbols; Indications For Use; Product Description; Contraindications For Use - Cogentix Medical Urgent PC Mode D'emploi

DESCRIPTION OF SYMBOLS

Prescription Use Only
Product Reference Number
SN
Serial Number
Lot Number
Consult Instructions for Use
60°C
Temperature limitation of -20°C (-4°F) to 60°C (140°F)
-20°C
80%
Relative humidity of 20% to 80%, non-condensing
20%
1060
hPa
Atmospheric pressure of 500 hPa to 1060 hPa
500
hPa
Type BF Applied Part
Waste electrical and electronic equipment (WEEE)
should not be disposed as unsorted municipal waste;
WEEE should be collected separately.
Direct Current
9V Alkaline Battery
Classified by Underwriters Laboratories Medical
Equipment With Respect to Electric Shock, Fire, and
Mechanical Hazards Only. In accordance with UL 60601-1,
CAN/CSA C22.2 No. 601.1, EN 60601-1, IEC 60601-1,
and IEC 60601-2-10.
Manufacturer
Authorized Representative in European Community

INDICATIONS FOR USE

The Urgent PC Neuromodulation System is intended to treat patients
®
suffering from urinary urgency, urinary frequency, and urge incontinence.
The Urgent PC is also indicated for the treatment of fecal incontinence.
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PRODUCT DESCRIPTION

The Urgent PC Neuromodulation System is a minimally invasive
neuromodulation system designed to deliver retrograde access to the
sacral nerve through percutaneous electrical stimulation of the tibial
nerve. The method of treatment is referred to as Percutaneous Tibial
Nerve Stimulation (PTNS).
The Urgent PC Neuromodulation System is a combination of the Urgent
PC Stimulator (Stimulator) and the Urgent PC Lead Set (Lead Set). The
Stimulator and Lead Set are sold separately.
The Stimulator is a battery powered, external pulse generator and
is designed, constructed, and manufactured for multiple use. The
Stimulator is to be used only in conjunction with the single-use Lead
Set. The Lead Set (comprised of the Lead Wire, Needle Electrode,
and Alcohol Pad) transfers the electrical current from the Stimulator to
the tibial nerve via the Needle Electrode. The only components of the
Urgent PC Neuromodulation System provided sterile are the Needle
Electrodes.

CONTRAINDICATIONS FOR USE

1. In order for treatment to be effective and to avoid any possible
problems or complications, the device is contraindicated for use on
patients who have the following history or conditions:
» 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
2. The Stimulator is not intended for intra-cardiac or trans-thoracic use.
3. Do not use the Stimulator on patients who are pregnant or planning
to become pregnant while using this product.
4. Concurrent use of medical monitoring equipment during stimulation
is not recommended.
5. This device is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
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