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Related Manuals for NanoVibronix PAIN SHIELD MD
Summary of Contents for NanoVibronix PAIN SHIELD MD
- Page 1 User Manual Cat. # 20-100-0005 Ver. 06 (ROW)
- 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
PainShield® MD User Manual Table of Contents Introduction ...................... 4 1.1. General Safety................4 Indications for Use .................... 5 Safety……….…………………………………………………………………………………………………...6 3.1. Contraindications............... 6 3.2. Warnings ..................7 3.3. Precautions ................9 Product Features..................... 10 4.1. Preset Treatment ..............10 4.2. Battery Operation .............. -
Page 4: Introduction
PainShield® MD User Manual 1. Introduction Thank you for choosing the PainShield® MD. This manual contains precautions and general instructions for the operation, application and care of PainShield® MD. In order to obtain maximum lifetime and efficiency from PainShield® MD and to ensure it is properly operated, please read and understand this manual thoroughly. -
Page 5: Indications For Use
PainShield® MD User Manual 2. Indications for Use PainShield® MD is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions. The low intensity and low frequency ultrasound energy is effective within a diameter of 20 cm and a depth of approximately 3 cm. -
Page 6: Safety
PainShield® MD User Manual 3. Safety 3.1. 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 7: Warnings
Do not replace any part of PainShield® MD with components or parts other than those supplied by NanoVibronix. Do not connect PainShield® MD to any device or W AR NI NG system other than the parts supplied with it. - Page 8 PainShield® MD User Manual Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the PainShield® MD, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Page 9: Precautions
PainShield® MD User Manual 3.3. Precautions Use PainShield® MD with caution in the following areas: Following a laminectomy involving major tissue removal In patients susceptible to bleeds Over anesthetized areas of impaired skin Treatment of children should be performed under adult supervision. ... -
Page 10: Product Features
PainShield® MD User Manual 4. Product Features 4.1. Preset Treatment PainShield® MD is preconfigured to provide intermittent ultrasonic output at a preset frequency of 90 kHz and low intensity, neither of which can be modified by the user. When in ON mode, PainShield® MD alternates automatically between 2 phases: Active phase—PainShield®... -
Page 11: Product Components
PainShield® MD User Manual 5. Product Components PainShield® MD has two main components: a treatment actuator and a driver. A charger is included in every kit. 5.1. 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 5.2. 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 Actuator port ON/OFF button Operation screen display ... -
Page 13: Operation
PainShield® MD User Manual 6. Operation 6.1. 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. 6.2. 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: Preparation For Trigeminal Neuralgia Treatment
PainShield® MD User Manual Attach the actuator patch to the skin, with the adhesive side down over the area where the pain is most intense. If the skin is broken or if the pain is located near a joint, attach the actuator on flat healthy skin area adjacent to the source of pain. -
Page 17: Applying Therapy
6.5. 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: Press the ON/OFF button until you hear the shut-off beep. -
Page 18: Monitoring Painshield Md
PainShield® MD User Manual 6.6. 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 Explanation Manufacturer name... - Page 19 PainShield® MD User Manual Symbols/Text Displayed Explanation Working mode information ① ② ③ (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®...
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Page 20: 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 21: Replacing The Actuator
6.8. 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 alert when it is disconnected from the actuator). -
Page 22: Frequently Asked Questions
How can I order additional Please contact NanoVibronix or your local distributor. actuators or patches? Can PainShield® MD be Yes. PainShield® MD is perfectly suited for use in used with physical therapy. -
Page 23: 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 24: Appendix A: Electromagnetic Compliance
PainShield® MD User Manual 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 the PainShield® should assure that it is used in such an environment. - Page 25 PainShield® MD User Manual Table 2: PainShield® MD Electromagnetic Immunity Guidance and Manufacturer’s Declaration – Electromagnetic Immunity PainShield® MD is intended for use in the electromagnetic environment specified below. The customer or user of the PainShield® MD should assure that it is used in such an environment. Compliance Electromagnetic environment - Immunity test...
- Page 26 PainShield® MD User Manual Table 3: PainShield® MD Electromagnetic Immunity (Continuation) Guidance and Manufacturer’s Declaration – Electromagnetic Immunity PainShield® MD is intended for use in the electromagnetic environment specified below. The customer or user of the PainShield® MD should assure that it is used in such an environment. Immunity test IEC 60601 level Compliance level...
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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, 1250mAh (full charging time ~ 2 h) Dimensions: 137 mm (L) x 47 mm (W) x 21 mm (H) Weight: Approximately 85 g... -
Page 28: Appendix C: Labels
90kHz 00167 Type: Divergent 1282 IP22 2019-12 Waveform: CW NanoVibronix Ltd . BNR 6:1, ERA=6cm² 9 Derech Hashalom St , Nesher3665112, Israel Adaptor: UES 18LCP-050240SPA Acoustic power: 0.4W CEpartner 4U BV Input: 100-240VAC, 50/60Hz, 500 mA Esdoornlaan13, 3951 DB Maarn, Netherlands Output: 5VDC, 2.4A... -
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) The product must be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless 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. -
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. -
Page 31: Appendix F: Troubleshooting
The device does not turn on Charge the driver using the supplied charger for 2 hours. If issue is not resolved, contact the NanoVibronix local distributor The actuator is not staying secured Turn off the device. Remove the to the skin during treatment actuator patch (See 6.7).
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Questions and answers
I don't see any place to reorder patches and duel actuator.