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Related Manuals for NanoVibronix PainShield
Summary of Contents for NanoVibronix PainShield
- Page 1 User Manual Cat. # 20-100-0001 Ver. 03 (USA)
- 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.
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Page 4: Table Of Contents
PainShield® MD User Manual Table of Contents Introduction ..................5 General Safety ................5 Prescription Use Only ..............5 Indications for Use ................6 Safety……………………………………………………………………………………………….7 Contraindications ............... 7 Warnings ..................8 Precautions ................9 Product Features ................. 9 Preset Treatment ..............10 Battery Operation .............. -
Page 5: Introduction
PainShield® MD is simple to administer, and operates on a broad range of body areas, allowing the delivery of ultrasound treatment for up to 6.5 hours, at a preset frequency of 90kHz. -
Page 6: Indications For Use
PainShield® MD User Manual Indications for Use PainShield® MD is required to be prescribed by a licensed healthcare provider The PainShield® MD is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such ... -
Page 7: Safety
PainShield® MD User Manual Safety Contraindications PainShield® MD is prohibited for use in the following cases: Patients with cancer and bone metastases under treatment area Directly on the eye Directly over an open wound Directly over ischemic tissues in individuals with vascular disease ... -
Page 8: Warnings
MD in water or any other liquid. Use PainShield® MD only as instructed in this manual. Do not use any part of PainShield® MD that appears damaged. W AR NI NG Do not modify PainShield® MD in any way. -
Page 9: Precautions
Use caution when removing the actuator patch from the skin after use. The safety and effectiveness of PainShield® MD has not been established in patients who are or have been treated by other medical devices including but not limited to:... -
Page 10: Product Features
6.5 hours of continuous therapy on a single battery charge. After 6.5 hours, PainShield® MD automatically switches off, and the battery must be recharged. You can switch PainShield® MD to OFF mode, manually, at any point of time. PainShield MD Adhesive Patches ®... -
Page 11: Product Components
Actuator Driver Single-use patches Charger PainShield® MD has two main components: a treatment actuator and a driver. A charger is included in every kit. The PainShield MD Treatment Actuator ® The treatment actuator incorporates an ultrasonic transducer and connects to the driver with a cable. -
Page 12: The Painshield ® Md Driver
PainShield® MD User Manual The PainShield MD Driver ® The driver that supplies electrical signals to the transducer in the actuator has the following parts: Built-in rechargeable battery Charging port Connection cable ON/OFF button Operation screen display... -
Page 13: Operation
PainShield® MD User Manual Operation Charging the Driver When the battery is fully charged, the driver has an operating life of 6.5 hours. Charge the driver in accordance with the following guidelines: Charge the driver only with the supplied charger. -
Page 14: Preparing The Treatment Area
PainShield® MD User Manual Charging takes about 2 hours. When the battery is fully charged, the battery icon appears full. Preparing the Treatment Area 1. Remove excess hair from the treatment area. 2. Clean the treatment area thoroughly with soap and water or an alcohol prep pad. - Page 15 PainShield® MD User Manual Remove the center protective layer from the adhesive leaving the outer strips attached to insure easy placement. Place the actuator on the exposed adhesive at the center of the patch, with the metal transducer facing up and the wire aligned with the open notch in the patch.
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Page 16: Applying Therapy
Use the ON/OFF button to switch the driver ON and OFF. To switch the driver ON: Press the ON/OFF button until you hear a beep and the NanoVibronix logo appears on the screen. To switch the driver OFF: ... -
Page 17: Monitoring Painshield Md
PainShield® MD User Manual Monitoring PainShield ® The driver screen displays information in respect of the functioning of ® PainShield MD. The table below explains the symbols and text that may be displayed on the screen at various times. Symbols/Text Displayed... - Page 18 (IDLE phase) 1. Battery indicator 2. Treatment cycle number 3. Output power ④ 4. PainShield® MD is in IDLE phase. Screensaver during working mode (automatically replaces the information screen after 3 minutes) PainShield® MD is ON. To refresh the display of information, briefly press the ON/OFF button.
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Page 19: Removing The Actuator Patch
PainShield® MD User Manual Symbols/Text Displayed Explanation Screensaver in Charging Mode The display is dimmed and keeps scrolling vertically. To refresh the display of information press the ON/OFF button briefly (that is, for less than 2 seconds). The actuator is damaged or not connected to the driver. -
Page 20: Replacing The Actuator
It is recommended to replace the actuator after 30 treatments. New actuators can be ordered from NanoVibronix or your local distributor. Switch OFF the PainShield driver (to prevent the driver from sounding an alarm when it is disconnected from the actuator). -
Page 21: Frequently Asked Questions
Place the actuator on clean, dry, healthy skin over or close actuator correctly? to the source of pain and in full contact with the skin. Do I need to use an You do not need to use ultrasound gel with the PainShield® ultrasound gel under the PainShield® MD actuator? Can I put the actuator The actuator should never be placed on an open wound;... -
Page 22: Product Care
Use the actuator with a new patch for each treatment session. A faulty unit which is still under warranty, can be sent to NanoVibronix for replacement. Do not immerse any part of PainShield® MD in water or any other liquid. -
Page 23: Appendix A: Electromagnetic Compliance
Table 1: PainShield® MD Electromagnetic Emission Guidance and Manufacturer’s Declaration – Electromagnetic Emissions PainShield® MD is intended for use in the electromagnetic environment specified below. The customer or user of PainShield® MD should assure that it is used in such an environment. Emission test Compliance Electromagnetic Environment –... - Page 24 Portable and mobile RF communications equipment should be used no closer to any part of the PainShield, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
- Page 25 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 PainShield® MD is used exceeds the applicable RF compliance level above, PainShield® MD should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating PainShield®...
- Page 26 Equipment and PainShield® MD PainShield® MD is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of PainShield® MD can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and PainShield®...
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Page 27: Appendix B: Specifications
PainShield® MD User Manual Appendix B: Specifications Driver model FD-14A Frequency: 90 kHz ± 0.001 kHz Voltage output: 12 V p-p Current output: Up to 0.3 A RMS Rechargeable battery: Lithium-Ion, 3.7V, 1200mAh (full charging time ~ 2 h) Dimensions: 113 mm (L) x 39.4 mm (W) x 12.6 mm (h) -
Page 28: Appendix C: Labels
PainShield® MD User Manual Appendix C: Labels Figure 1, Figure 2, Figure 3 and Figure 4 show PainShield® MD labels. Figure 1: Driver Label Figure 2: Actuator pouch label Figure 3: Kit label Figure 4: Patches pouch labels... -
Page 29: Appendix D: Symbols
PainShield® MD User Manual Appendix D: Symbols CE mark Refer to instruction manual/booklet Type of BF applied part Rated frequency or rated frequency range(s) (Hz) Separate collection for electrical and electronic equipment Manufacturer Temperature limits Authorized representative in the European Community... -
Page 30: Appendix E: Warranty
NanoVibronix warrants that the PainShield® MD driver shall be defect-free for a period of one year from 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 and at its expense.
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