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Summary of Contents for NanoVibronix URO SHIELD
- Page 1 User Manual Cat. # 20-100-0022 ver. 02 (USA)
- Page 2 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.
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Page 3: Table Of Contents
UroShield® User Manual Table of Contents Introduction ..................6 Biofilm Formation and Urinary Tract Infections ......6 General Safety ................7 Indications for Use ................8 Safety Warnings and Cautions ............. 9 Product Features ................12 Mains and Battery Operation ..........12 Operating Cycle ................ - Page 4 UroShield® User Manual Appendix B: Specifications..............31 Appendix C: Labels.................. 32 Appendix D: Symbols ................33 Appendix E: Warranty ................34 20-100-0022 Ver. 02...
- Page 5 Patient Insert and healthcare providers the accompanying Healthcare Provider Insert. Healthcare facilities using the UroShield should make NanoVibronix, Inc., and FDA aware of any adverse events under 21 CFR Part 803. Healthcare facilities should ensure healthcare providers using the...
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Page 6: Introduction
UroShield® User Manual 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. The UroShield® device is to be used only as directed in this manual. -
Page 7: General Safety
UroShield® User Manual General Safety Thoroughly 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 operation procedures and safety precautions outlined in this manual. 20-100-0022 Ver. -
Page 8: Indications For Use
UroShield® User Manual 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. 20-100-0022 Ver. 02... -
Page 9: Safety Warnings And Cautions
UroShield® User Manual Safety Warnings and Cautions The UroShield is not intended for use for suprapubic or other types of catheterization other than catheterization through the urethra with a Foley catheter. Insertion and removal of catheters and connection, operation, and disconnection of the UroShield®... - Page 10 UroShield® User Manual The UroShield® has no user serviceable parts. If it is not operating correctly, contact the local representative of NanoVibronix. No part of the UroShield® should be replaced with components or parts other than those supplied by NanoVibronix.
- Page 11 UroShield® User Manual The UroShield® is intended for use in professional healthcare facilities (e.g., Hospitals, , Temporary Hospitals, Nursing Homes, Long-term Care, etc.). The UroShield® driver is not waterproof. Do not expose it to water. Recharge the UroShield® only with the supplied charger or recommended USB power bank devices.
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Page 12: Product Features
UroShield® User Manual Product Features Mains and Battery Operation The UroShield® can be powered by the AC mains or via its internal rechargeable battery. During normal use it can be continuously connected to a wall outlet. However, to provide patient mobility it can be powered by the internal battery for up to 6 hours (when fully charged). -
Page 13: Product Components
UroShield® User Manual Product Components The UroShield® has two primary components: an actuator and a driver. An AC power adapter with a recharging cable is also supplied. The Actuator The small, lightweight actuator clips onto the urinary catheter after the catheter’s insertion into the patient's urethra. -
Page 14: 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 USB port Connection 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. -
Page 15: 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 16 UroShield® User Manual Place the actuator on the catheter in accordance with the following: For women, make sure that there is 2 to 3 cm of space between the actuator and the point where the catheter exits the body. For men, make sure that there is 5 to 10 cm of space between the actuator and the point where the catheter exits the body.
- Page 17 UroShield® User Manual Insert the actuator 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. Connect the supplied charger to the driver charging port. 10.
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Page 18: Switching The Uroshield On Or Off
UroShield® User Manual The driver display will show the following screens in quick succession: The UroShield® is now working and charging at the same time (you do not need to wait for the battery to charge fully, which takes about 2 hours). Switching the UroShield ON or OFF ®... -
Page 19: Recharging The Uroshield Battery
UroShield® User Manual Recharging the UroShield Battery ® The UroShield® can be used for a duration of 6 hours without being constantly recharged by connecting it to a AC wall outlet using the recharging adapter. The internal battery should be recharged when the internal battery capacity is less than 10% (see section 6.5.2). -
Page 20: Instructing The Patient
UroShield® User Manual Instructing the Patient Instruct the patient as follows: The patient 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. ... -
Page 21: Monitoring The Uroshield
UroShield® User Manual Monitoring the UroShield ® 6.5.1 Driver Display Icons during Normal Functioning The table below explains the icons and text that may be 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®... - Page 22 UroShield® User Manual Icons/Text Shown Explanation Battery charge indicator. The battery is charging. The UroShield® is OFF. The battery icon fills gradually to show charging progress. If the screen has dimmed, you can brighten it by pressing the ON/OFF button briefly (that is, for less than 2 seconds).
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Page 23: Disconnecting The Driver From The Actuator
UroShield® User Manual Icon on Flashing Display Explanation Action Required This icon appears for Connect the driver to the several seconds when mains with the supplied the battery has less than charger 5% capacity left. The UroShield® then shuts down automatically. Actuator malfunction. -
Page 24: 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 bathing, switch OFF the UroShield®. Disconnect the driver from the actuator. Place the driver in a clean, dry area to insure the driver is not at risk to come in contact with water. -
Page 25: Frequently Asked Questions
UroShield® User Manual Frequently Asked Questions Question Answer Can the UroShield® be UroShield should be used only with catheters made of used with catheters uncoated silicone. made of any type of material? With which catheter The UroShield® can be used with urinary catheter sizes 12, sizes can the 14, 16, 18, 20, and 22 French. -
Page 26: Product Care
Nevertheless, the driver is not intended for use in the presence of flammable liquids. The driver does not contain recyclable material. The driver has a 1 year warranty. A faulty unit which is within the warranty period can be sent to NanoVibronix for replacement. 20-100-0022 Ver. 02... -
Page 27: The Actuator
UroShield® User Manual The Actuator The actuator is designed to work effectively for 30 days and single use 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. -
Page 28: Appendix A: Electromagnetic Compliance
UroShield® User Manual 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. Emissions test Compliance Electromagnetic environment - guidance... - Page 29 UroShield® User Manual Table 2: UroShield® Electromagnetic Immunity Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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. Electromagnetic environment - Immunity test IEC 60601 level...
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Page 30: Uroshield Essential Performance
UroShield® User Manual Table 3: UroShield® Electromagnetic Immunity (Continuation) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 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. Immunity test IEC 60601 level Compliance level... -
Page 31: Appendix B: Specifications
UroShield® User Manual Appendix B: Specifications UroShield Driver Frequency: 90 kHz ± 0.001 kHz, modulated by 30 Hz Voltage output: 12 V p-p Rechargeable battery: Lithium-Ion, 3.7 V, 1250 mAh (full charging time ~ 2 hours) Dimensions: 137 mm (L) x 47 mm (W) x 21 mm (H) Weight: Approximately 85 g Housing:... -
Page 32: Appendix C: Labels
1282 U . S. Pat. N 7, 393, 501; 7, 829, 029 IP22 2019-10 90kHz + 30Hz NanoVibronix Ltd . Adaptor: UES18LCP-050240SPA 9 Derech Hashalom St , Nesher 3665112 , Israel Power: 0.4W Input: 100-240VAC, 50/60Hz, 500 mA CEpartner 4U BV Output : 5VDC, 2.4A... -
Page 33: 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 Use by YYYY-MM Serial number Part number... -
Page 34: Appendix E: Warranty
NanoVibronix warrants that the UroShield® driver shall be defect-free for a period of one year from the product date of purchase. 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.
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