NanoVibronix URO SHIELD User Manual Download Page 8 | Manualshive

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UroShield® User Manual

20-100-0022 Ver. 02

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2

Indications for Use

The NanoVibronix™ UroShield™ is an extracorporeal accessory to indwelling
urinary catheters intended to aid in the reduction of catheter-associated
urinary tract infection (CAUTI) incidence in patients requiring long-term (≥ 14
days) indwelling catheterization.

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Summary of Contents for URO SHIELD

Page 1: ...User Manual Cat 20 100 0022 ver 02 USA...

Page 2: ...ble for errors or omissions Trademarks patents and copyrights apply NanoVibronix Inc 525 Executive Boulevard Elmsford N Y 10523 USA Tel 1 914 233 3004 Fax 1 914 376 6111 Email info nanovibronix com We...

Page 3: ...tor 13 5 2 The UroShield Driver 14 6 Operation 15 6 1 Connecting the UroShield 15 6 2 Switching the UroShield ON or OFF 18 6 3 Recharging the UroShield Battery 19 6 4 Instructing the Patient 20 6 5 Mo...

Page 4: ...UroShield User Manual 20 100 0022 Ver 02 4 Appendix B Specifications 31 Appendix C Labels 32 Appendix D Symbols 33 Appendix E Warranty 34...

Page 5: ...e declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564 b 1 of the Act 21 U S C 360bbb 3 b 1 Note for Healthcare Facilities Health...

Page 6: ...ion or attachment of planktonic bacteria to the catheter surface It is thought that the bacteria use touch sensors to attach to a solid surface 2 This occurs within a few hours after urinary catheter...

Page 7: ...ghly read and understand the precautionary and operating instructions before attempting to operate the UroShield Observe the precautionary and operational labels on the product Periodically review the...

Page 8: ...r Use The NanoVibronix UroShield is an extracorporeal accessory to indwelling urinary catheters intended to aid in the reduction of catheter associated urinary tract infection CAUTI incidence in patie...

Page 9: ...ve urinary infection Do not use the UroShield in the presence of flammable materials and liquids The UroShield is classified as internally powered intermittently operated ordinary equipment with a dis...

Page 10: ...ectromagnetic immunity of this equipment and result in improper operation Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no clos...

Page 11: ...to water Recharge the UroShield only with the supplied charger or recommended USB power bank devices Do not attempt to open or remove any of the covers of the UroShield The lithium ion rechargeable ba...

Page 12: ...can be powered by the internal battery for up to 6 hours when fully charged The internal battery can be fully charged in about 2 hours 4 2 Operating Cycle When the UroShield is ON it alternates betwee...

Page 13: ...catheter after the catheter s insertion into the patient s urethra When the UroShield is active the actuator generates acoustic waves on the surface of the catheter The actuator itself does not conta...

Page 14: ...cable to connect the actuator ON OFF button Operational display screen The driver is small and lightweight and can be attached see figure below using a lanyard or placed on the patient s bed When the...

Page 15: ...1 Make sure that UroShield application occurs shortly following catheter insertion into the bladder 2 Gently pull on the catheter until you feel slight resistance 3 Remove the actuator from its packa...

Page 16: ...5 to 10 cm of space between the actuator and the point where the catheter exits the body Make sure that the direction of the actuator connection cable is towards the patient Attach the actuator to th...

Page 17: ...tuator cable plug into the driver making sure to orient the plug correctly in relation to the socket and also making sure that the plug is fully inserted and secured 9 Connect the supplied charger to...

Page 18: ...urned off and not connected to the mains press the ON OFF button for 2 3 seconds About 30 seconds following above display sequence the driver display shows the battery level and actuator connection as...

Page 19: ...internal battery capacity is less than 10 see section 6 5 2 2 The recharging adapter should be connected to the AC wall outlet and the other end USB connector should be plugged into the recharging po...

Page 20: ...atient should not pull readjust or open the actuator The patient should not disconnect the actuator from the driver The patient should not press the ON OFF button The patient should inform medical sta...

Page 21: ...shown on the driver display during normal functioning of the UroShield Icons Text Shown Explanation Manufacturer s name Shown briefly when you plug the UroShield into the mains or switch it ON Produc...

Page 22: ...aver The UroShield is ON You can show the battery charge indicator and actuator status by pressing the ON OFF button briefly that is for less than 2 seconds 6 5 2 Alerts and Troubleshooting When the U...

Page 23: ...function The actuator is not connected to the driver or is damaged Make sure the actuator is properly connected to the driver If the actuator is properly connected and the malfunction icon is displaye...

Page 24: ...er in a clean dry area to insure the driver is not at risk to come in contact with water The actuator can remain attached to the catheter while the patient is showering or bathing Prior to reconnectin...

Page 25: ...ch catheter sizes can the UroShield be used The UroShield can be used with urinary catheter sizes 12 14 16 18 20 and 22 French Can the actuator be reused after catheter removal No The actuator is for...

Page 26: ...3 The Driver The life expectancy of the driver is 5 years To clean the driver use wipes with 70 alcohol or equivalent disinfecting solution Do not use solvents such as acetone as they may damage the p...

Page 27: ...only A new actuator should be applied with each catheter change If the actuator becomes soiled it can be cleaned with a damp sponge and then allowed to dry After use the actuator must be disposed of t...

Page 28: ...ectromagnetic environment guidance RF emissions CISPR 11 Group 1 The UroShield uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any int...

Page 29: ...Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line Class II ME equipment Mains power quality...

Page 30: ...such an environment Immunity test IEC 60601 level Compliance level IEC 61000 4 6 Conducted RF 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM bands 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to...

Page 31: ...ours Dimensions 137 mm L x 47 mm W x 21 mm H Weight Approximately 85 g Housing ABS UroShield Actuator Dimensions 42 mm x 34 mm x 15 mm Weight including cable 20 g Housing Polypropylene Charger Voltage...

Page 32: ...P 050240SPA Input 100 240VAC 50 60Hz 500mA Output 5VDC 2 4A P N 10 800 0003 NanoVibronix Ltd 9 Derech Hashalom St Nesher 3665112 Israel 2019 10 4003 CEpartner 4U BV Esdoornlaan13 3951DB Maarn Netherla...

Page 33: ...uency or rated frequency range s Hz Separate collection for electrical and electronic equipment Manufacturer Authorized representative in the European Community Lot Do not reuse Use by YYYY MM S N Ser...

Page 34: ...be returned to NanoVibronix accompanied by a notice that describes the nature of the problem This warranty shall not apply to a product which has been subject to misuse unauthorized use negligence ac...

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