UPC 200-B Urgent PC Stimulator Instructions for Use Reg G Sept 2016

Prescription Use Only Product Reference Number

SN

Serial Number Lot Number Consult Instructions for Use 60°C

-20°C 80% 20%

500 hPa

1060 hPa

Temperature limitation of -20°C (-4°F) to 60°C (140°F) Relative humidity of 20% to 80%, non-condensing Atmospheric pressure of 500 hPa to 1060 hPa

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.

Type BF Applied Part

CONTRAINDICATIONS FOR USE

Waste electrical and electronic equipment (WEEE) should not be disposed as unsorted municipal waste; WEEE should be collected separately.

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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

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DESCRIPTION OF SYMBOLS

2. 3. 4. 5.

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 The Stimulator is not intended for intra-cardiac or trans-thoracic use. Do not use the Stimulator on patients who are pregnant or planning to become pregnant while using this product. Concurrent use of medical monitoring equipment during stimulation is not recommended. This device is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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. 4

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This Instructions for Use is NOT a comprehensive reference to therapeutic techniques for the treatment indications noted for the Urgent PC. 2. Users should be familiar with appropriate application and techniques involved in the use of the Stimulator and the Lead Set. 3. Do not use the Stimulator in or around water. 4. Do not use the Stimulator or Lead Set if the skin in the area of use is inflamed, infected, or otherwise compromised. 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 open battery cover while Stimulator is powered on or connected to the patient. 6. Patients should not spend more than 30 minutes in Therapy mode during a single treatment session. 7. The patient should remain comfortably seated, or in a supine position, for the duration of the treatment. The patient should not rise or walk until the treatment is complete, as mobility during treatment has not been assessed. 8. Do not use any Lead Set component (Lead Wire, Needle Electrode or Alcohol Pad) if the component is damaged. 9. Do not use the Needle Electrode or the Alcohol Pad if the packaging for either component has been opened or damaged. 10. Do not reuse the single-use Needle Electrode, Surface Electrode, or Lead Wire. 11. Dispose of used Lead Set components in a bio-hazardous material disposal container. 12. Remove battery if equipment is not likely to be used for some time. 13. Simultaneous connection of a patient to high frequency surgical equipment may result in burns at the site of the Stimulator electrodes and possible damage to the Stimulator. 14. Device operation in close proximity (e.g., 1 meter) to short wave or microwave therapy equipment may produce instability in the Stimulator output. 15. The application of the electrodes near the thorax may increase the risk of cardiac fibrillation. 6

16. Do not apply stimulation across or through the head, directly on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus), chest, upper back or crossing over the heart. 17. The Stimulator has electric shock protection, Type “Internally Powered Equipment.” 18. The Stimulator enclosure is type IPX0 and does not protect against the ingress of water. 19. Unauthorized modification of this equipment may cause injury to either the patient or the device operator.

PRECAUTIONS 1. 2. 3.

4.

Prior to using the Urgent® PC Neuromodulation System, read and understand all instructions in the Urgent PC Stimulator Instructions for Use and Urgent PC Lead Set Instructions for Use. Caution should be used for patients with suspected or diagnosed heart problems, especially those relating to the pacing or electrical functioning of the heart. The following are potential health risks associated with this type of device and therapy: »» Discomfort and pain (including throbbing pain) at, or near, the stimulation site, including the patient’s lower leg and foot »» Bleeding at the needle site »» Redness/inflammation at, or near, the stimulation site »» Potential for peripheral nerve damage »» Numbness of toes »» Stomach ache Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and placed into service according to EMC guidelines provided (see page 18 for more information). a. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment. b. The end user of this product should assure it is used in an appropriate environment. i. Portable and mobile RF Communications equipment (i.e., cell phones) should not be used at close distances. ii. Power frequency magnetic fields should be at levels characteristic of a typical commercial, hospital or clinic environment. 7

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WARNINGS

Urgent PC Stimulator 1.

2.

Design Features: »» Lightweight, ergonomic, handheld design »» Electronic touch pad controls »» Raised and embossed buttons to provide tactile feedback »» LCD status screen to provide operational status »» One-way fit connection site for Lead Set Electrical Current Settings: Current Setting

Current (in mA)

Current Setting

Current (in mA)

0

0

10

4.5

1

0.15

11

5.0

2

0.5

12

5.5

3

1.0

13

6.0

4

1.5

14

6.5

5

2.0

15

7.0

6

2.5

16

7.5

7

3.0

17

8.0

8

3.5

18

8.5

9

4.0

19

9.0

»» Pulse characteristics: ◦◦ Fixed pulse frequency of 20 Hz ◦◦ Pulse width of 200 µseconds ◦◦ Square waveform »» Resistance of 500-4000 Ohms.

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PRODUCT SPECIFICATIONS

Button Controls The Stimulator is controlled by raised buttons on the device. These buttons are: Power button – turns power on and off Note: To turn the power on or off, the user is required to depress the Power button for approximately 2 seconds. This is designed to protect the Stimulator from inadvertent status changes. Test (yellow) button – begins Test mode Upon entering Test mode, the default current setting will be 0 (0mA). At the completion of the Test mode, the final current setting shall be the baseline setting in Therapy mode. Note: To activate Test mode, the user is required to depress the Test mode button for approximately 2 seconds. This is designed to protect the Stimulator from inadvertent status changes. Therapy (green) button – begins Therapy mode The default current setting for Therapy mode will be the final current setting in Test mode. However, the Current Adjustment button may be used to increase or decrease the current level at any time. Note: To activate Therapy mode, the user is required to depress the Therapy mode button for approximately 2 seconds. This is designed to protect the Stimulator from inadvertent status changes. Stop (red) button – stops flow of current in Test or Therapy mode Note: If treatment is stopped or interrupted during Therapy mode, the remaining Therapy mode time is displayed. Once stopped, the treatment session will need to be restarted, beginning with Test mode. Depending on when the session was interrupted, a new Lead Set may be required. Current Adjustment button – increases or decreases current Note: The current is adjustable in both Test and Therapy modes. Note: if the Stimulator is not in Test or Therapy mode and no button is pressed for 15 minutes, the Stimulator will power down.

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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.

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Status Screen Icons and alpha-numeric characters on the Status Screen provide operational feedback. These include:

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.

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.

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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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Insert the Needle Electrode »» Locate the insertion site for the Needle 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. »» 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.

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INSTRUCTIONS FOR USE

Connect Lead Wire to the Stimulator »» Plug the one-way fit connector of the Lead Wire into the Stimulator’s connection site. Verify that the one-way fit connector is inserted correctly.

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Attach the Surface Electrode »» Remove the adhesive backing from the Surface Electrode. »» Place the Surface Electrode near the medial aspect of the calcaneus on the same leg as the Needle Electrode insertion. Attach Needle Electrode Clip »» Depress the plunger on the Needle Electrode Clip to expose the connection hook at the tip. Loop the connection hook around the Needle Electrode and release.

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»» Using the Current Adjustment button, slowly increase the current while monitoring the patient for a response. Patient response may be either motor or sensory. For some patients it is both. Motor response is typically a toe flex or fan, or an extension of the entire foot. Sensory response is generally described as a tingling sensation that travels away from the insertion site, towards the heel, arch or toes.

Determine Current Setting for Therapy »» Turn on the Stimulator by pressing and holding the Power button for approximately 2 seconds. An audible tone will sound and symbols will appear on the screen.

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Note: If the Lead Wire Status icon is blinking, ensure that the Lead Wire connector is secure in the Stimulator’s connection site. »» Enter Test mode by pressing and holding the Test button for approximately 2 seconds. The default setting for Test mode is level 0 (0mA current).

or

Note: If the Inactive Current icon appears, current is not flowing through the Lead Set. Check the security of the Lead Wire connector, the adherence of the Surface Electrode, and the placement of the Needle Electrode Clip.

»» Once a patient response is confirmed, reduce current setting by one level and begin Therapy mode. »» If the incremental adjustment of amplitude fails to elicit either a motor or a sensory response, press the Stop button and reposition the Needle Electrode slightly. Re-enter Test mode using the preceding instructions. »» If repositioning the Needle Electrode and repeating the current step-up procedure fails to elicit patient response, discard the Needle Electrode. Open the second Needle Electrode included in the Lead Set and repeat the procedure on the other leg. Conduct Therapy »» After completing Test mode, Therapy mode can be entered by either: 1) Pressing the Stop button to end Test mode and then pressing the Therapy button to start Therapy mode. 2) Pressing the Therapy button while the Test mode is still active. Note: Test mode is a prerequisite to Therapy mode. »» To ensure optimal treatment, the default current setting for Therapy mode will be the final current setting in Test mode. However, the Current Adjustment button can be used to increase or decrease the current level at any time during Therapy mode. 15

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TREATMENT FREQUENCY »» Conduct 12 treatments, typically once per week. »» After the initial 12 treatments, slowly increase the time between 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.

PERMISSIBLE OPERATING ENVIRONMENT »» Ambient temperature »» Relative humidity »» Atmospheric pressure

Use only a 9V alkaline battery (e.g., Duracell) to power the Stimulator. Never operate the Stimulator with any type of line-powered battery eliminator or other external power source. Battery life is dependent on the intensity of treatment; a new 9V battery will perform approximately 12 treatments at a current setting of 5mA (level 11). Recycle or dispose of batteries in compliance with applicable local and/or national regulations. If the Stimulator is not working properly, contact Cogentix Medical. 16

10°C to 40°C 30% to 75% 700 hPa to 1060 hPa

MANUFACTURING The Stimulator is manufactured in accordance with the safety norms set forth by the International Electrotechnical Commission and Underwriters Laboratory, IEC/UL 60601, including electromagnetic compatibility.

ELECTROMAGNETIC COMPATIBILITY Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Urgent PC Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Urgent PC Stimulator should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF emissions CISPR 11

Group 1

The Urgent PC Stimulator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Not applicable

The Urgent PC Stimulator is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings for domestic purposes.

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not applicable

MAINTENANCE After each treatment the surface of the Stimulator device should be wiped down with a soft cloth. The cloth may be slightly dampened, but not saturated, with water or with a mix of isopropyl alcohol (70%) and water (30%).

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»» Therapy mode time is automatically set for 30 minutes. »» When the therapy time has elapsed, Therapy mode will automatically end, the current will be inactive, and the Stimulator will emit a series of three beeps. Complete Treatment Session »» Turn off the Stimulator by holding down the Power button for approximately 2 seconds. »» Remove the Needle Electrode Clip from the Needle Electrode. »» Using a smooth, fluid motion, quickly remove the Needle Electrode from the leg. If bleeding occurs, apply slight pressure and bandage. »» Disconnect the Lead Wire from the Stimulator and properly dispose of Lead Set components. »» The treatment session is now complete.

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Urgent PC Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Urgent PC Stimulator should assure that it is used in such an environment.

The Urgent PC Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Urgent PC Stimulator should assure that it is used in such an environment.

Immunity Test

Immunity IEC 60601 Compliance Test Test Level Level

IEC 60601 Test Level

Compliance Level

Electrostatic discharge (ESD) IEC 61000-4-2

± 6kV contact ± 8kV air

± 6 kV contact

Electrical fast transient/burst IEC 61000-4-4

± 2kV for power supply lines

Not applicable

Surge IEC 61000-4-5

± 1kV differential mode

± 8 kV air

Electromagnetic Environment – Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

± 1kV for input/ output lines

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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<5 % UT (>95 % dip in UT) for 0,5 cycle

3 Vrms

Not applicable

Not applicable

Not applicable

Not applicable

Portable and mobile RF communications equipment should be used no closer to any part of the Urgent PC Stimulator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2√P

Not applicable

±2 kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Conducted 3 Vrms 150 kHz to RFIEC 61000-4-6 80 MHz

Electromagnetic Environment – Guidance

Radiated RFIEC 61000-4-3

3 V/m 80MHz to 2,5 GHz

3 V/m

d = 1,2√P 80 MHz to 800 MHz d = 2,3√P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strength from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

40 % UT (>95 % dip in UT) for 5 cycles 70 % UT (>95 % dip in UT) for 25 cycles

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

<5 % UT (>95 % dip in UT) for 5 sec

a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Urgent PC Stimulator is used exceeds the applicable RF compliance level above, the Urgent PC Stimulator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Urgent PC Stimulator b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

3 A/m

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Not applicable

Not applicable

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Urgent PC is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Urgent PC Stimulator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Urgent PC Stimulator as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter W

Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d = 1,2√P

80 MHz to 800 MHz d = 1,2√P

800 MHz to 2,5 GHz d = 2,3√P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

(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.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structure, objects and people.

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: 20

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Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Urgent PC Stimulator

Uroplasty LLC, a wholly owned subsidiary of Cogentix Medical 5420 Feltl Road, Minnetonka, MN 55343 USA tel 866.258.2182 fax 866.255.4522 email [email protected] www cogentixmedical.com

Uroplasty BV Hofkamp 2, 6161 DC Geleen, The Netherlands tel +31 (0)88.423.79.21 email [email protected] www cogentixmedical.com

UK Customer Care: 0800.032.5964 email [email protected] tel

© 2015 Cogentix Medical. All Rights Reserved. PN 4288 Rev. G 09/2016

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