NanoVibronix UROSHIELD User Manual
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NanoVibronix UROSHIELD User Manual

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User Manual
Cat. # USUM005 Ver. 07

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Summary of Contents for NanoVibronix UROSHIELD

  • Page 1 User Manual Cat. # USUM005 Ver. 07...
  • Page 3 Without prior notice and without obligation, the contents of this manual may be revised to incorporate changes and improvements. Every effort is made to ensure that the information is complete and accurate at the time of publication. Nevertheless, NanoVibronix cannot be held responsible for errors or omissions. Trademarks, patents, and copyrights apply.

  • Page 4: Table Of Contents

    UroShield® User Manual Table of Contents Introduction..................6 Biofilm Formation and Urinary Tract Infections......6 Pain, Discomfort, and Spasm ............. 7 General Safety................7 Indications for Use................8 Safety Warnings and Cautions............. 9 Product Features ................11 Mains and Battery Operation ..........11 Operating Cycle................
  • Page 5 UroShield® User Manual Appendix A: Electromagnetic Compliance..........26 Appendix B: Specifications..............30 Appendix C: Labels.................. 31 Appendix D: Symbols ................32 Appendix E: Warranty ................33 Appendix F: Z-Shield for Percutaneous Nephrostomy Catheters ... 34 USUM005 Ver. 07...

  • Page 6: Introduction

    Thank you for choosing the UroShield®. This manual contains general instructions for operation, application, precautions and care. In order to obtain maximum life and efficiency from the UroShield® and to assist in its proper operation, please read and understand this manual thoroughly. This UroShield®...

  • Page 7: Pain, Discomfort, And Spasm

    Pain, Discomfort, and Spasm By means of the same acoustic waves that mitigate against biofilm, the UroShield® also reduces friction between the catheter and the patient’s internal tissues. This decreases the pain, discomfort and spasm associated with indwelling urinary catheters.

  • Page 8: Indications For Use

    Pain, discomfort, and spasm  The UroShield® can be used with catheters made of any material and sized 14, 16, 18, 20, or 22 French, for up to 30 days. Note that the UroShield® is not for use with percutaneous nephrostomy catheters.

  • Page 9: Safety Warnings And Cautions

    UroShield® should be performed only by qualified medical staff and in accordance with the relevant medical facilities care guidelines. Do not use the UroShield® as a treatment for  an active urinary infection. Do not use the UroShield® in the presence of ...
  • Page 10 UroShield® User Manual The UroShield® driver is not waterproof.  Do not expose it to water. Charge the UroShield® only with the  supplied charger. Do not attempt to open or remove any of  C AUT IO N the covers of the UroShield®.

  • Page 11: Product Features

    Product Features Mains and Battery Operation The UroShield® can be powered by the mains or by its rechargeable battery. In normal use it should be continuously connected to a mains socket. However, to provide patient mobility it can be powered by the battery for up to 6 hours (when fully charged).

  • Page 12: Product Components

    The Actuator The small, lightweight actuator clips onto the urinary catheter after the catheter’s insertion into the patient's bladder. When the UroShield® is active, the actuator generates acoustic waves on the surface of the catheter. The actuator itself does not have contact with the patient’s skin. It is for single use only: that is, for use with one catheter only (until the catheter is replaced or for a maximum of 30 days).

  • Page 13: The Uroshield Driver

    UroShield® User Manual The UroShield Driver ® The driver supplies electrical signals to the actuator. It has the following parts: Built-in rechargeable battery  Charging port  Connection cable  ON/OFF button  Operational display screen  The driver is small and lightweight and can be placed on the patient’s bed.

  • Page 14: Operation

    UroShield® User Manual Operation Connecting the UroShield ® Make sure that UroShield application occurs shortly following catheter insertion into the bladder. Gently pull on the catheter until you feel slight resistance. Remove the actuator from its packaging. Peel off the protective strips from the inside of both halves of the actuator.
  • Page 15 UroShield® User Manual Place the actuator on the catheter in accordance with the following: In females, make sure that there are 2 to 3 cm between the actuator and the point where the catheter exits the body. In males, make sure that there are 5 to 10 cm between the actuator and the point where the catheter exits the body.
  • Page 16 UroShield® User Manual Insert the actuator cable plug into the driver cable socket, making sure to orient the plug correctly in relation to the socket, and also making sure that the plug is fully inserted and secured. Connect the supplied charger to the driver charging port.

  • Page 17: Switching The Uroshield

    UroShield® User Manual The UroShield® is now charging and is ready to be switched on (you do not need to wait for the battery to charge fully, which takes about 2 hours). Switching the UroShield ON or OFF ® To switch the UroShield® ON or OFF, press the ON/OFF button for 2–3 seconds.

  • Page 18: Instructing The Patient

    UroShield® User Manual Instructing the Patient Instruct the patient as follows: The patient should not pull or open the actuator.  The patient should not disconnect the actuator from the driver.  The patient should not press the ON/OFF button.

  • Page 19: Monitoring The Uroshield

    UroShield®. Icons/Text Shown Explanation Manufacturer’s name (shown briefly when you plug the UroShield® into the mains or switch it ON). Product name. Software version number (shown briefly after the manufacturer’s name). Battery charge indicator.
  • Page 20 (that is, for less than 2 seconds). 6.4.2 Alarms and Troubleshooting When the UroShield® requires attention, an audible alert sounds and the driver display flashes. The icon on the display will indicate what action is required: see the table below.

  • Page 21: Disconnecting The Driver From The Actuator

    Disconnecting the Driver from the Actuator Switch OFF the UroShield® (to prevent the driver from sounding an alarm when it is disconnected from the actuator). Hold the driver cable socket in one hand and the actuator cable plug in the other hand, then pull them apart.

  • Page 22: Showering And Bathing

    UroShield® User Manual Showering and Bathing The UroShield® driver is not waterproof and should not be exposed to water. If the patient wants to shower or bath, do the following: Before entering the bathroom, switch OFF the UroShield®. Disconnect the driver from the actuator.

  • Page 23: Frequently Asked Questions

    Appendix catheters? With which catheter sizes can the The UroShield® can be used with urinary UroShield® be used? catheter sizes 14, 16, 18, 20, and 22 French. Can the actuator be reused after No. The actuator is for use with a single...

  • Page 24: Product Care

    UroShield® User Manual Product Care Storage Before use, store the UroShield® in its shipment box under the following conditions: Temp: 10 °C to 30 °C (50 °F to 86 °F)  Humidity: 20% to 55%  The driver battery shelf life is 2 years.

  • Page 25: The Actuator

    UroShield® User Manual The Actuator The actuator is designed for single use only: that is, for use with one catheter only and each actuator will work effectively for 30 days. If the actuator becomes soiled, it can be cleaned with a damp sponge and then allowed to dry.

  • Page 26: Appendix A: Electromagnetic Compliance

    Table 1: UroShield® Electromagnetic Emission Guidance and Manufacturer’s Declaration – Electromagnetic Emissions UroShield® is intended for use in the electromagnetic environment specified below. The customer or user of the UroShield® should assure that it is used in such an environment. Emission test Compliance Electromagnetic Environment –...
  • Page 27 UroShield® is battery powered. During system charging, it is <5% U <5% U recommended that the (>95% dip in UroShield® be powered by an (>95% dip in ) for 5 sec uninterruptible power supply. ) for 5 sec  is the A/C mains voltage prior to application of the test level.
  • Page 28 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 UroShield® is used exceeds the applicable RF compliance level above, the UroShield® should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the UroShield®.
  • Page 29 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the UroShield® UroShield® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the UroShield® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the UroShield®...

  • Page 30: Appendix B: Specifications

    UroShield® User Manual Appendix B: Specifications Driver model FD-14B Frequency: 90 kHz ± 0.001 kHz, modulated by 30 Hz Voltage output: 12 V p-p Rechargeable battery: Lithium-Ion, 3.7 V, 1200 mAh (full charging time ~ 2 hours) Dimensions: 125 mm (L) x 39 mm (W) x 13 mm (H)

  • Page 31: Appendix C: Labels

    UroShield® User Manual Appendix C: Labels Figures 1–4 show the UroShield® labels. Figure 1: Driver Label Figure 2: Actuator Label Figure 3: Actuator Pouch Label Figure 4: Kit Label USUM005 Ver. 07...

  • Page 32: Appendix D: Symbols

    UroShield® User Manual Appendix D: Symbols CE mark Refer to instruction manual/booklet Type BF applied part Rated frequency or rated frequency range(s) (Hz) Separate collection for electrical and electronic equipment Manufacturer Authorized representative in the European Community Do not reuse...

  • Page 33: Appendix E: Warranty

    NanoVibronix warrants that the UroShield® driver shall be defect-free for a period of one year from the product date of shipment. The liability of NanoVibronix under this warranty is limited to the repair or replacement (at NanoVibronix’s choice) of any allegedly defective part or parts under warranty by NanoVibronix at its expense.

  • Page 34: Appendix F: Z-Shield For Percutaneous Nephrostomy Catheters

    Appendix F: Z-Shield for Percutaneous Nephrostomy Catheters A sister product, Z-Shield, is intended for use with percutaneous nephrostomy catheters. Instead of the UroShield® actuator, the Z-Shield has an acoustically- active stabilization patch. The patch does the following: Stabilises the catheter ...

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