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NanoVibronix PainShield MD User Manual

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Summary of Contents for NanoVibronix PainShield MD

  • 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 1.0 INTRODUCTION ® 1.1 PainShield essential performance 1.2 General Safety 1.3 Prescription Use Only 1.4 Contents 2.0 INDICATIONS FOR USE 3.0 SAFETY 3.1 Contraindications 3.2 Warnings 3.3 Precautions 4.0 THE PAINSHIELD ® SYSTEM ® 4.1 The PainShield Treatment Actuator ® 4.2 PainShield Adhesive Patches ®...
  • Page 4 This manual contains general instructions for the operation, application and care of PainShield . To obtain ® maximum life and efficiency from PainShield and to assist ® in its proper operation, please read and understand this manual thoroughly. PainShield is to be used only ®...
  • Page 5 PAINSHIELD ESSENTIAL PERFORMANCE ® PainShield produces low frequency, low ® intensity ultrasonic waves for the relief of pain, muscle spasm and improvement of local circulation. The ultrasonic waves are generated by a transducer that is incorporated into the actuator. GENERAL SAFETY Thoroughly read and understand the safety and operating instructions before attempting to operate the PainShield...
  • Page 6 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 as: Pain.
  • Page 7 CONTRAINDICATIONS PainShield is contraindicated 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. Over the uterus in pregnant patients. Over bone growth centres until bone growth is complete.
  • Page 8 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.
  • Page 9 PRECAUTIONS Use PainShield with caution in the ® following areas: Following a laminectomy involving major tissue removal. In patients susceptible to bleeds. Over anesthetised areas of impaired skin. Treatment of children should be performed under adult supervision. In children, avoid use over the epiphyseal growth plate area.
  • Page 10 PainShield has three components: ® A Treatment Actuator Adhesive Patches and a Driver A charger is also included. Driver Actuator Charger Power Button Adhesive Patch...
  • Page 11 THE PAINSHIELD TREATMENT ACTUATOR ® The treatment actuator incorporates an ultrasonic transducer and connects to the driver with a cable. The transducer is the active element that converts electric signals to ultrasound waves. For effective treatment, the transducer must be in full contact with the skin. PAINSHIELD ADHESIVE PATCHES ®...
  • Page 12 OPERATING CYCLE PainShield is preconfigured to provide ® intermittent ultrasonic output at a pre-set frequency which cannot be modified by the user. When in ON mode, the PainShield alternates ® between 2 phases: Active phase — PainShield delivers 30 minutes ®...
  • Page 13 STORAGE CONDITIONS PainShield 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 35°C...
  • Page 14 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. Refer to Appendix D for conditions of warranty. The driver does not contain recyclable material.
  • Page 15 CHARGING THE PAINSHIELD DRIVER ® When the battery is fully charged, the PainShield can be used without mains power ® connection for approximately 6.5 hours. Charge the driver in accordance with the following guidelines: Charge the driver only with the supplied charger.
  • Page 16 PREPARING THE TREATMENT AREA Remove excess hair from the treatment area. Clean the treatment area thoroughly with soap and water or an alcohol wipe. Ensure the treatment area is dry and free from any creams or oils which could affect the adherence of the actuator patch.
  • Page 17 5-10cm 3 cm fig.2 Place the actuator on the exposed adhesive at the centre of the patch, with the metal transducer facing up and the wire aligned with the open notch in the patch. (fig.3) fig.3...
  • Page 18 Attach the actuator patch to the skin, with the adhesive side down over the area where the pain is most intense. (fig.4) fig.4 If the skin is broken or if the pain is located near a joint, attach the actuator to the flat healthy skin area adjacent to the source of pain.
  • Page 19 Use the ON/OFF button to switch the driver ON and OFF. To switch the driver ON: Press and hold the ON/OFF button until you hear a beep, and the NanoVibronix logo appears on the screen. Note: Briefly pressing the ON/OFF button refreshes the information screen. The screen saver is replaced by the information screen.
  • Page 20 PAINSHIELD DISPLAYS ® The information below explains the symbols and text that may be displayed on the driver display during normal functioning of the PainShield at various times. ® Manufacturer name Displayed briefly when you switch ON the driver. Product name Software version number (Displayed during device initiation).
  • Page 21 REMOVING THE ACTUATOR PATCH Use caution when removing the actuator patch from the skin. Gently remove the patch from the actuator avoiding applying tension to the wire. Important: Do not reuse the adhesive patch as this may affect the performance.
  • Page 22 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 23 The device does not turn on. Solution Charge the driver using the supplied charger for 2 hours. If issue is not resolved, contact the NanoVibronix local distributor. Issue or Problem The actuator is not staying secured to the skin during treatment.
  • Page 24 Question How do I place the actuator correctly? Answer Place the actuator on clean, dry, healthy skin over or close to the source of pain and in full contact with the skin. Question Do I need to use an ultrasound gel under the PainShield actuator? ®...
  • Page 25 Question How can I order additional actuators and patches? Answer Please contact NanoVibronix or your local distributor. Question Can PainShield be used with ® physical therapy? Answer Yes.
  • Page 27 PAINSHIELD ELECTROMAGNETIC ® EMISSION Table 1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ® PainShield 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 28 PAINSHIELD ELECTROMAGNETIC ® IMMUNITY Table 2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ® PainShield 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. Immunity IEC 60601 Compliance...
  • Page 29 PAINSHIELD ELECTROMAGNETIC ® IMMUNITY Table 3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ® PainShield 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. Immunity IEC 60601 level Compliance...
  • Page 30 PAINSHIELD DRIVER & ACTUATOR ® SPECIFICATIONS PainShield Driver ® Frequency 90 kHz ± 0.001 kHz Voltage output 12 V p-p Current output Up to 0.3 A RMS Rechargeable battery Lithium-Ion, 3.7 V, 1250 mAh (full charging time ~ 2 h) Dimensions 137 mm (L) x 47 mm (W) x 21 mm (H)
  • Page 31 PAINSHIELD CHARGER SPECIFICATIONS ® PainShield Charger ® Voltage input 100-240 VAC, 0.4-0.2A, 50/60 Hz Output 5 VDC, 2.4 A Note: Use an appropriate adaptor for local mains. PAINSHIELD PRODUCT CLASSIFICATIONS ® Classification & Compliance Product classification Low risk device classification: CE Mark - Class IIa / FDA Clearance - Class II...
  • Page 32 PAINSHIELD 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 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 33 IP rating per IEC 60529 Continuous Wave Milliwatt per centimeter squared Centimeter squared Watt (1W = 1000mW) 21 CFR 801.109/ Prescription devices. US Federal law restricts this device to sale by or on the order of a physician or physical therapist licensed by the law of the State in which he practices to use or order the use of the device.
  • Page 34 (at NanoVibronix’s choice) of any allegedly defective part or parts under warranty by NanoVibronix and at its expense. The defective driver should be returned to NanoVibronix accompanied by a notice that describes the nature of the problem.
  • Page 36 20-100-0004 Ver 06 info@nanovibronix.com www.nanovibronix.com ©2021 NanoVibronix...