Instruction for use
Contents
1. apply over bone growth centers until bone growth is complete Do not apply directly on the eye Do not apply directly over ischemic tissues in individuals with vascular disease Pregnant women should be treated only with physician consent Precautions In children it is preferable to avoid usage over the epiphyseal growth plate area Following a laminectomy when major tissue removal has occurred Over anesthetic areas When hemorrhagic diathesis is present General warnings and precautions Treating of children should be done under adult supervision Following treatment some redness might occur in the treated area The redness should resolve naturally within a few hours Do not place the treatment patch directly on open wound The safety and effectiveness of PainShield has not been determined in patients who are being treated by or who have received other medical devices including but not limited to pacemakers electrical stimulators radiofrequency generators surgical meshes or other surgical implants PSIFU009 Ver 03 USA NanoVibronix Inc 105 Maxess Road Suite 124 Melville NY 11747 Tel 631 574 4410 Europe NanoVibronix Ltd 9 Derech Hashalom St Nesher 36603 Israel Tel 972 4 820 0581 www nanovibronix com info nanovibronix com PainShield Instruction for use 2 Place the ultrasonic transducer the metal p 2 v part in the center of the treatment patch over the pain source or nex2. PainShield Attention this guide provides the basic principals of operation for the PainShield device It is not intended to replace the complete user manual Please read the complete manual PSUMO003 before using the PainShield and make sure that you understand all aspects of PainShield operation Contact snaps Driver cable Ultrasound transducer Reusable facial treatment patch B incorporated into patch Driver FD 14A Reusable treatment patch A The PainShield MD is a microprocessor controlled therapeutic ultrasound device that produces low frequency low intensity ultrasonic waves for the relief of pain muscle spasm and improvement of localized blood circulation The ultrasonic waves are generated by a unique transducer incorporated into a treatment patch There are two types of the patches Reusable treatment patch A and Reusable facial treatment patch B The treatment patch should be placed on the skin at the desired treatment area or adjacent to it For maximal effectiveness ensure that the ultrasonic transducer is in full contact with the skin Pain Shield MD model FD 14A specifications Frequency range 90 kHz 0 001 Hz 12V Output voltage Rechargeable battery Lithium ion full charging time 6 h Dimensions 113 mm h x 39 4 mm w x 12 6 mm h Weight Driver 70 g patch 10 g Acoustic power 0 4 W Contraindications Do not use in patients with cancer and bone metastases Do not
3. pressing the ON OFF button and hold it during 2 seconds Device is turning Off Treatment patch is Battery discharged and Charging in progress disconnected or damaged requires charging Approvals and compliance with Requlatory Representative in USA standards MedicSence C 4 291 Hiliside Avenue 0473 FDA 510 K cleared Somerset MA 02726 IEC 60601 1 IEC 60601 2 Tel 1 508 479 6116 Fax 1 508 677 1418 george medicsense com
4. t to it and tighten the patch to the skin ke a a ZNT 1 Ensure that the treatment area is clean dry and free of wounds or other lesions Remove the protective liner from the treatment patch ON OFF 4 Press the ON OFF button at the upper side of the device for about 2 seconds till you hear a beeping sound to turn the device on 3 Following treatment patch placement connect it to the PainShield device using the snaps at the end of the connecting cable Removal and storage of the treatment patch Reusable patch A gently remove the patch from the skin Moist the sticky area of the patch with water and put the protective liner back and store it in its original package Reusable facial patch B gently remove the patch from the skin Moist the sticky area of the patch with water and put the protective liner back and Store it in its original package Pain Shield driver screens Treatment cycle IDLE mode number C1 C6 screen as PainShield Time of treatment in Ver 30 03 the cycle 0 30 min 290 ae Device is turned On Treatment screen indicates treatment phase Each cycle has an active period of 30 min followed by an IDLE period of 30 min The PainShield is active for 6 5 hours and then it shuts down automatically During treatment a screen server is activated For returning to normal screen press shortly the ON OFF button It is possible to turn the device off at any time by
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