Cogentix Medical UPC 250 Gebrauchsanweisung Seite 2

Use Only with the Urgent
DESCRIPTION OF SYMBOLS
Prescription Use Only
Product Reference Number
Consult Instructions for Use
Do not reuse
60°C
Temperature limitation of -20°C (-4°F) to 60°C (140°F)
-20°C
80%
Relative humidity 20% to 80%, non-condensing
20%
1060
hPa
Atmospheric pressure of 500 hPa to 1060 hPa
500
hPa
Waste electrical and electronic equipment (WEEE) should not be disposed
as unsorted municipal waste; WEEE should be collected separately.
Manufacturer
Authorized Representative in European Community
Lot Number
Expiration Date
Not made with natural rubber latex.
INDICATIONS FOR USE
The Urgent PC Lead Set, used in conjunction with the Urgent PC Stimulator, is
®
designed to deliver percutaneous tibial nerve stimulation (PTNS).
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 Lead Set
(Lead Set) and the Urgent PC Stimulator (Stimulator). The Lead Set (comprised of the
Lead Wires, Needle Electrode, and Alcohol Pad) transfers the electrical current from the
Stimulator to the tibial nerve via the Needle Electrode. The entire Lead Set is intended
for single use only and is not to be reused.
Note: These Lead Sets are only compatible with the UPC200-A (USA) and UPC200-B (CE).
WARNINGS
1. Prior to using the Lead Set, read and understand all instructions in the Stimulator
Instructions for Use. Users should be familiar with appropriate applications and
techniques involved in the use of the Stimulator and Lead Set.
2. This Instructions for Use is NOT a comprehensive reference to therapeutic
techniques for the treatment indications noted for the Urgent PC.
3. Do not use the Lead Set if the skin in the area of use is inflamed, infected, or
otherwise compromised.
4. Monitor patients during treatment for pain or skin irritation/inflammation. Discontinue use
of the Stimulator if the patient complains about these symptoms or any other discomfort.
5. Do not use the Needle Electrode or the Alcohol Pad if the packaging for either
component has been opened or damaged.
6. Do not use any component (Needle Electrode, Surface Electrode, or Lead Wire) if
the component is damaged.
7. Do not reuse any component.
8. Properly dispose of the Lead Set components as bio-hazardous materials.
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PC Stimulator
®
9. Reuse of the Urgent PC Lead Set is associated with risks of infection and cross-
contamination.
10. Unauthorized modification of this equipment may cause injury to either the patient
or the device operator.
HOW SUPPLIED
The Lead Set is made of multiple components, packaged together within a foil pouch:
» 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.
PROCEDURE
Follow the directions in the Stimulator Instructions for Use to conduct PTNS: insert
approximately 2 cm (¾") of the Needle Electrode into the leg, connect the Lead Wire to
the Stimulator, attach the Surface Electrode, attach Needle Electrode Clip, test patient
response, stimulate the patient, disconnect and dispose of the components, clean and
store the Stimulator.
PERMISSIBLE OPERATING ENVIRONMENT
» Ambient temperature 10°C to 40°C
» Relative humidity 30% to 75%
» Atmospheric pressure 700 hPa to 1060 hPa
WARRANTY
Cogentix Medical warrants that reasonable care has been used to design and
manufacture this product. Product will be replaced if Cogentix Medical determines its
material or workmanship is defective. This is Cogentix Medical's only warranty, and it
excludes all other warranties (including those implied by operation of law). Cogentix
Medical is not responsible for matters within the control of the user or others, such as
product handling and storage, patient selection and diagnosis and treatment procedures.
This Limited Warranty is limited to its express terms. In particular:
(1) Except as expressly provided by this Limited Warranty, COGENTIX MEDICAL
IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE
PRODUCT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT
OR OTHERWISE.
(2) This Limited Warranty is made only to the purchaser of the Product. AS TO ALL
OTHERS, COGENTIX MEDICAL MAKES NO WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WHETHER
ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. THIS LIMITED
WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.
Any implied warranties of merchantability or fitness are specifically excluded.
Statements and descriptions in marketing literature, while generally describing this
product, do not constitute any warranties.
DISCLAIMER OF WARRANTIES
Cogentix Medical excludes all warranties and responsibilities for:
» Improper use of or tampering with the product
» Failure to follow instructions provided in this insert, and/or
» Failure to follow the Instructions for Use for Urgent PC Stimulator and Urgent PC
Lead Set.
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