NanoVibronix UroShield User Manual
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NanoVibronix UroShield User Manual

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Summary of Contents for NanoVibronix UroShield

  • Page 2 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 3: Table Of Contents

    5.1 Operating Cycle 5.2 Mains and Battery Operation 6.0 PRODUCT CARE 6.1 The Driver 6.2 The Actuator 6.3 Storage 6.4 Environmental Operating Conditions 7.0 OPERATION 7.1 Charging the UroShield Driver ® 7.2 Connecting the UroShield ® 7.3 Switching the UroShield ON or OFF ®...
  • Page 4 This user manual contains the instructions for operation, application and care of UroShield . To obtain ® maximum life and efficiency from UroShield and to assist ® in its proper operation, please read and understand this manual thoroughly. UroShield is to be used ®...
  • Page 5 DISCLAIMER FOR PHYSICIANS AND PATIENTS IN THE USA The UroShield has neither been cleared or approved to aid in the reduction of catheter- associated urinary tract infection (CAUTI) incidence in patients requiring long-term (≥ 14 days) indwelling catheterization. The UroShield is under Enforcement Discretion for use during the COVID-19 epidemic;...

  • Page 6: Biofilm Formation And Urinary Tract Infections

    UroShield®. This user manual should be retained for future reference. ESSENTIAL PERFORMANCE The UroShield® is applied on the urethral or suprapubic catheter and emits ultrasound energy to its surface. The waves interfere with the attachment of bacteria, which is the initial step in biofilm formation, and increase antibiotic efficacy against biofilm bacteria.
  • Page 7 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. The UroShield is to be worn continuously ® and is intended to minimise bacterial adhesion and colonisation on the catheter surfaces.

  • Page 8: Contraindications

    ® A healthcare professional or a caregiver should periodically inspect and confirm integrity of connection and operation of UroShield® when used by a patient known to be incapable of managing the device. UroShield has no user serviceable parts. ® If it is not operating correctly, contact the local representative of NanoVibronix.
  • Page 9 UroShield system to verify it is ® operating normally. Use of accessories, transducers, and cables other than those specified or provided by NanoVibronix could result in increased electromagnetic emissions or decreased electromagnetic immunity of this medical device and result in improper operation. P ortable RF communications equipment (including peripherals such as antenna...
  • Page 10 UroShield has two components: ® A Driver and an Actuator A Mains Adapter/Charger is also included Driver Actuator Mains Adapter/ Charger Power Button Catheter (Not Included)

  • Page 11: The Uroshield Actuator

    ACTUATOR ® The actuator is attached onto the urinary catheter after the catheter’s insertion into the patient’s urethra. When the UroShield ® driver is active, the actuator generates ultrasound waves on the surface of the catheter. The actuator is intended for single use only, should be worn continually and changed every 30 days.

  • Page 12: Operating Cycle

    OPERATING CYCLE UroShield is preconfigured to provide ® intermittent ultrasound output at a pre-set frequency which cannot be modified by the user. When in ON mode, UroShield alternates ® between 2 phases: Active phase UroShield delivers 15 minutes of ® ultrasound therapy on the surface of the catheter. A low audible sound may be heard.

  • Page 13: The Driver

    T he driver is flame resistant according to UL-94HB. It does not contain flammable materials and will not accelerate a fire. The driver is not intended for use in the presence of flammable liquids. A faulty unit which is still under warranty, can be sent to NanoVibronix for replacement. Refer to Appendix D for conditions of warranty. The driver does not contain recyclable material. THE ACTUATOR...
  • Page 14 STORAGE CONDITIONS UroShield storage conditions: ® 40°C 35°C 40°C 35°C 40°C 35°C 5 - 40°c 5°C 5°C 5°C 5°C 5°C 5°C 10 - 80% 106kPa 106kPa 106kPa 70kPa 70 - 106 kPa 70kPa 70kPa ENVIRONMENTAL OPERATING CONDITIONS The recommended environmental operating conditions are: 40°C...

  • Page 15: Charging The Uroshield Driver

    USB power bank can be used to recharge the UroShield battery by connecting a USB cable from the power bank to the UroShield rechargeable (USB-C) port. When the driver begins to charge, the screen lights up brightly and displays the battery icon.

  • Page 16: Connecting The Uroshield

    CONNECTING THE UROSHIELD® UroShield application should occur after ® catheter insertion into the bladder. Remove the actuator from its packaging. Remove the two protective strips from the inside of the actuator. (fig.2) fig.2 5-10cm Place the actuator on the catheter in accordance with the following: 3 cm 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.
  • Page 17 3 cm 5-10cm 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. Make sure that the direction of the actuator 3 cm connection cable is towards the patient. Attach the actuator to the catheter so that the catheter enters and exits the actuator through the grooves at either...
  • Page 18 UroShield UroShield Ver: 41.05 Ver: 41.05 The UroShield is now working and charging ® at the same time. The UroShield is supplied ® UroShield with a small amount of charge, to fully UroShield Ver: 41.05 charge the battery it takes approximately Ver: 41.05...

  • Page 19: Switching The Uroshield On Or Off

    SWITCHING THE UROSHIELD ® ON OR OFF To switch the UroShield ON, when the driver is ® NanoVibronix turned off and not connected to the mains, press and hold the ON/OFF button for 2–3 seconds. After the intro sequence, the driver display shows the status of the battery and actuator connection as shown in the following screen: UroShield Ver: 41.05...

  • Page 20: Monitoring The Uroshield

    MONITORING THE UROSHIELD ® The following information explains the symbols and text that may be displayed on the driver display during normal functioning of the UroShield ® various times. Driver Display Glossary Manufacturer name NanoVibronix Displayed briefly when you NanoVibronix switch ON the driver.

  • Page 21: Alerts And Troubleshooting

    ALERTS 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: Explanation The battery has less than 10% capacity. Action Required Connect the driver to the mains power supply with the supplied AC charger.

  • Page 22: The Actuator

    DISCONNECTING THE UROSHIELD® Switch OFF the UroShield to prevent the ® driver from sounding an alert when it is disconnected from the actuator. Hold the driver in one hand and the actuator cable plug in the other hand, then pull them apart. (fig.5) fig.5...
  • Page 23 ® made of uncoated silicone, polyvinyl chloride (PVC), latex rubber, siliconized latex, and all other catheter materials. Question What catheter sizes can the UroShield ® be used with? Answer The UroShield can be used with urinary ®...
  • Page 24 Table 1 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 25 IMMUNITY Table 2 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 IEC 60601 Compliance...
  • Page 26 Table 3 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...
  • Page 27 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 28: Uroshield Specifications

    UROSHIELD DRIVER & ACTUATOR ® 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 (D)
  • Page 29 UROSHIELD CHARGER SPECIFICATIONS ® UroShield Charger ® Voltage input 100-240 VAC, 0.4-0.2 A, 50/60 Hz Output 5 VDC, 2.4 A Note: Use an appropriate adaptor for local mains. UROSHIELD PRODUCT CLASSIFICATIONS ® Classification & Compliance Product classification Low risk device classification: CE mark – Class II a Compliance with standards EN 60601-1;...
  • Page 30 UROSHIELD SYMBOL INDEX ® Refer to instruction manual/booklet Type BF applied part Rated frequency or rated frequency range(s) (Hz) The product must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether...
  • Page 31 UROSHIELD WARRANTY ® NanoVibronix warrants that the UroShield ® driver will 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 replacement (at NanoVibronix’s choice) of any allegedly defective part or parts under warranty by NanoVibronix at its expense.
  • Page 32 Cat. # 20-100-0022 Ver. 03 USA info@nanovibronix.com www.nanovibronix.com ©2021 NanoVibronix...

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