1
User Manual
USA
Page 1: ...1 User Manual USA...
Page 2: ...3 442 524 M 31 6 516 536 26 F 31 343 442 162 office CEpartner4U com info nanovibronix com www nanovibronix com Without prior notice and without obligation the contents of this manual may be revised to...
Page 3: ...ating 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 Conn...
Page 4: ...r 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...
Page 5: ...ices under section 564 b 1 of the Act 21 U S C 360bbb 3 b 1 NOTE FOR HEALTHCARE FACILITIES Healthcare facilities using the UroShield should make available to patients the accompanying Patient Insert a...
Page 6: ...polymeric matrix now adherent to the catheter surface is known as biofilm which is highly resistant to antibiotics and to the body s immune system The UroShield is intended to prevent bacterial biofi...
Page 7: ...ry 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 coloni...
Page 8: ...dasinternallypowered intermittentlyoperated ordinaryequipment withadisposabletypeBFappliedpart Use UroShield only as instructed in this manual Do not use the UroShield driver or accessories if they ap...
Page 9: ...sducers 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...
Page 10: ...hield has two components A Driver and an Actuator A Mains Adapter Charger is also included 1 2 5 3 4 1 Driver 2 Actuator 3 Mains Adapter Charger 4 Power Button 5 Catheter Not Included The UroShield Sy...
Page 11: ...that it is used on a new catheter THE UROSHIELD DRIVER The driver supplies electrical signals to the actuator It has the following parts Built in rechargeable battery Charging port Actuator port ON O...
Page 12: ...eard Idle phase UroShield is idle for 5 minutes MAINS AND BATTERY OPERATION The UroShield can be powered by mains or by its internal rechargeable battery To provide patient mobility it can be powered...
Page 13: ...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...
Page 14: ...perating conditions are 5 40 c 10 80 70 106 kPa 5 35 c 10 80 70 106 kPa 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 10...
Page 15: ...rnatively for patients who are wheelchair bound geriatric patients using a walker or ambulatory patients a USB power bank can be used to recharge the UroShield battery by connecting a USB cable from t...
Page 16: ...move the actuator from its packaging 3 Remove the two protective strips from the inside of the actuator fig 2 4 Place the actuator on the catheter in accordance with the following For women make sure...
Page 17: ...the catheter so that the catheter enters and exits the actuator through the grooves at either end of the actuator 6 Carefully close the actuator so that the two halves snap together 7 Make sure that t...
Page 18: ...tically turn on showing the following screens sequence The UroShield is now working and charging at the same time The UroShield is supplied with a small amount of charge to fully charge the battery it...
Page 19: ...oting After another 3 minutes the display shows the screensaver Note when the screensaver is shown you can return to the battery actuator status by pressing the ON OFF button briefly for less than 2 s...
Page 20: ...ctly working The UroShield is ON 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 brigh...
Page 21: ...lied AC charger Explanation This icon appears for several seconds when the battery has less than 5 capacity left The UroShield then shuts down automatically Action Required Connect the driver to the m...
Page 22: ...efore entering the bathroom switch OFF the UroShield driver 2 Disconnect the UroShield driver from the actuator 3 Place the driver in a clean dry area to insure the driver is not at risk to come in co...
Page 23: ...estion What catheter sizes can the UroShield be used with Answer The UroShield can be used with urinary catheter sizes 12 14 16 18 20 and 22 French Question Can the actuator be reused after catheter r...
Page 24: ...uidance 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 interference in nearby electro...
Page 25: ...d 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 should be that of a typic...
Page 26: ...uch an environment Immunity test IEC 60601 level Compliance level IEC 61000 4 6 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 27 283 MHz an...
Page 27: ...ld assure that it is used in such an environment Immunity test IEC 60601 level Compliance level IEC 61000 4 3 Radiated RF 10 V m 80 MHz to 2 7 GHz E 10 V m Proximity fields from RF wireless communicat...
Page 28: ...Lithium Ion 3 7 V 1250 mAh full charging time 2 hours Dimensions 137mm L x47mm W x21mm D Weight Approximately 85 g Housing ABS 9 UROSHIELD DRIVER ACTUATOR SPECIFICATIONS Dimensions 42mm L x34mm W x15...
Page 29: ...CATIONS UroShield Charger Classification Compliance 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 Product classification Low risk devi...
Page 30: ...rdless of whether or not they contain toxic substance at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner Consult your municipal autho...
Page 31: ...ix 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 or accident including but no...
Page 32: ...32 Cat 20 100 0022 Ver 03 USA info nanovibronix com www nanovibronix com 2021 NanoVibronix...
