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Related Manuals for NanoVibronix PAINSHIELD MD
Summary of Contents for NanoVibronix PAINSHIELD MD
- Page 1 User Manual Cat. # PSUM004 Ver. 09 (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 General Safety................4 Indications for Use................5 Safety ....................6 Contraindications............... 6 Warnings ..................7 Precautions ................8 Product Features ................. 9 Preset Treatment ............... 9 Battery Operation ..............9 ® PainShield MD Patches ............. -
Page 4: Introduction
PainShield® MD User Manual Introduction Thank you for choosing the PainShield® MD. This manual contains general instructions for operation, application, precautions, and care. In order to obtain maximum life and efficiency from the PainShield® MD and to assist in its proper operation, please read and understand this manual thoroughly. -
Page 5: Indications For Use
PainShield® MD User Manual Indications for Use The 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 Safety Contraindications The PainShield® MD is not 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 the PainShield® MD with components or parts other than those supplied by NanoVibronix. Do not connect the PainShield® MD to any device/system other than the parts supplied with it. PSUM004 Ver. 09... -
Page 8: Precautions
PainShield® MD User Manual Charge the PainShield® MD only with the supplied charger. Do not attempt to open or remove the cover of the PainShield® MD. C AUT IO N The lithium ion rechargeable battery in the PainShield® MD must not be disassembled, heated above 100 degrees Celsius, incinerated, or exposed to water. -
Page 9: Product Features
PainShield® MD User Manual Product Features Preset Treatment The 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 the PainShield® MD is ON, it alternates automatically between 2 phases: Active phase—the PainShield®... -
Page 10: Product Components
PainShield® MD User Manual Product Components The PainShield® MD has two components: a treatment patch and a driver. A charger is included. The PainShield MD Treatment Patch ® The reusable treatment patch comes in a pouch which also serves for storing the patch between treatment sessions. -
Page 11: The Painshield ® Md Driver
PainShield® MD User Manual and the side of the patch with hydrogel is placed on the skin. When the patch is removed from the skin, the liner is replaced to protect the hydrogel coating. The transducer in the center of the patch is the active element that converts electric signals to ultrasound waves. -
Page 12: 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 13: 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 Remove excess hair from the treatment area. Clean the treatment area thoroughly with soap and water or alcohol prep pad. - Page 14 PainShield® MD User Manual Place the patch on the area of treatment over healthy skin. The hydrogel adhesive attaches the patch to the skin. If the skin is broken, place the patch on adjacent healthy skin as illustrated below. Over painful area Next to wound When applying the patch next to an open wound, you can remove section A or section B of the patch by cutting along the dotted lines...
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Page 15: Applying The Smaller Patch To Treat Trigeminal Neuralgia
PainShield® MD User Manual Make sure that the ultrasonic active element is in full contact with the skin. Note: To ensure full contact of the active element with the skin, particularly when using the smaller patch or during prolonged use, consider using a wrap-type dressing (e.g. - Page 16 PainShield® MD User Manual Connect the driver cable to the two snap contacts on the patch. Remove the transparent protective liner from the patch. Save the liner for protecting the patch during storage. Place the patch next to the cheekbone when the pain is in the maxillary nerve (V ) or next to the lower jaw bone when the pain is in the mandibular nerve (V...
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Page 17: Applying Therapy
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 PainShield® MD User Manual Symbols/Text Displayed Explanation Working mode information ① ② ③ (ACTIVE phase) 1. Battery indicator 2. Treatment cycle number (C1 to C6) 3. Output power 4. Time elapsed since the beginning of ④ the current ACTIVE phase. Working mode information ①...
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Page 19: Removing The Patch
PainShield® MD User Manual Symbols/Text Displayed Explanation Charging mode information The battery icon fills gradually to show charging progress. 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). - Page 20 PainShield® MD User Manual Moisten the hydrogel layer with a little water. Replace the clear patch protective liner. Return the patch to its pouch. Do not leave the patch unpackaged in a dry place. C AUT IO N It will lose its hydration and will no longer adhere to the skin.
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Page 21: Frequently Asked Questions
Do not leave the patch unpackaged in a dry place. It will lose its hydration and will no longer adhere properly to the skin. How can I order Please contact NanoVibronix or your local distributor. additional patches? Can the PainShield® MD Yes. -
Page 22: Product Care
The treatment patch expiration date is printed on the patch pouch label. Do not use the patch after its expiration date. A faulty unit which is under the warranty period can be sent to NanoVibronix for replacement. PSUM004 Ver. 09... -
Page 23: 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® MD should assure that it is used in such an environment. - Page 24 PainShield® MD User Manual Immunity test IEC 60601 Compliance Electromagnetic Environment – Test level Level Guidance Surge ±1 kV ±1 kV Mains power quality should be IEC 61000-4-5 differential differential that of a typical commercial or mode mode hospital environment. ±2 kV ±2 kV common...
- Page 25 PainShield® MD User Manual Immunity test IEC 60601 Compliance Electromagnetic Environment – Test level Level Guidance Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
- Page 26 PainShield® MD User Manual Table 3: PainShield® MD Recommended Separation Distances Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the PainShield® MD The PainShield® MD is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the PainShield® MD can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 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) Weight: Approximately 70 g... -
Page 28: Appendix C: Labels
PainShield® MD User Manual Appendix C: Labels Figure 1 and Figure 2 show the PainShield® MD labels. Figure 1: Driver Label Figure 2: Patch Labels PSUM004 Ver. 09... -
Page 29: Appendix D: Symbols
PainShield® MD 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 Temperature limits Authorized representative in the European Community Beam nonuniformity ratio Serial number Effective radiating area... -
Page 30: Appendix E: Warranty
NanoVibronix warrants that the PainShield® MD driver shall be defect-free for a period of one year from the 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 at its expense.