Pain Shield MD User Manual
Contents
1. Specifications Driver model FD 14A Frequency 90 kHz 0 001 Hz Voltage output 12 V p p Current output Up to 0 3 A rms Rechargeable battery Lithium ion full charging time 6 h Dimensions 113 mm h x 39 4 mm w x 12 6 mm h Weight 70g Housing ABS Holding accessories Hanging strip pouch optional Applicator Patch model and type Reusable PRP 20 single attachment PDP 20 Acoustic power 0 4 W 0 4 W Frequency 90 kHz 0 001 Hz 90 kHz 0 001 Hz Beam non uniformity ratio 6 1 6 1 BNR Active treatment area ERA 6 cm 6 cm Adhesive area 33 cm 40 cm Dimensions 120 mm 50 mm 6 mm 0100 mm Weight 10g 5 6g Color Beige White Usage Multiple uses by a single Single attachment can be patient Approx 4 5 reused for several treatments treatment sessions until removal Charger Voltage input 100 240 V ac 138mA 50 60 Hz Output 5V dc 1A Note use an appropriate adaptor for local mains NanoVibronix Page 15 of 21 PainShield User Manual Labels PainShield MD driver s label Model FD 14A S N Note Recharge only with supplied adaptor This product complies with 21 CFR 1050 10 Caution 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 0473 CE ANI o A Output Frequency 9OkHz Type Divergent Not waterproof Waveform CW BNR 6 1 ERA 6cm Acoustic power2. NANO IBRONIX Curing through prevention Pain Shield MD User Manual Cat PSUMOO3 Ver 03 USA PainShield User Manual NanoVibronix Page 2 of 21 Pain Shield user manual Table of Contents GENERAL INFORMATION 4 CLINICAL INFORMATION 8 GENERAL DESCRIPTION 9 PAINSHIELD MD OPERATION 9 PAINSHIELD MD OPERATION 10 SPECIFICATIONS 15 LABELS 16 TROUBLESHOOTING 19 ADDRESSES 21 NanoVibronix Page 3 of 21 Pain Shield user manual General Information Introduction to ultrasound Ultrasound is a form of acoustical vibration occurring at frequencies above the 20 kHz perception limit of the human ear Ultrasound therapy effectiveness depends on transmitting pressure and displacement waves through body tissues Since the body is actually composed of a variety of tissue types the penetration depth will depend on the thickness of each tissue in the pathway of the ultrasound beam Therapeutic ultrasound is produced through a reverse piezoelectric effect Electric signals produced by the driver are delivered to an electrode that 1s in contact with the piezo electric element The signal applied to the piezo element surface produces mechanical vibrations or the so called reverse piezoelectric effect Ultrasonic power is expressed in watts W or watts per square centimetre W cm Average intensity W cm is obtained by measuring the total output of the applicator in watts and then divided by the size of the effective rad
3. 0 4W isl NANOVIBRONIX Ltd 9 Derech Hashalom st Nesher Israel www nanovibronix com single attachement treatment patch label Reusable treatment patch label Disposable PainShield patch model PDP 20 Reusable PainShield patch model PRP 20 Output Fre quency 90 KHz Lype Divergent BNE 6 1 Waveform CW ERA 6 cm2 Acoustic power 0 4WV Intensity 70 m VW cm2 Lift edge of patch while continuously wiping patch undersurface with alcohol to dissolve adhesive away from skin USA Federal law restricts this device to sale by or on the order of a physician or phisical therapist Output Fre quency 90 kHz Type Divergent BNR 6 1 Waveform CW ERA 6 cm2 Acoustic power 0 4 W Intensity 70 mM cm2 After patch removal moisten the hydro el portion of the patch with a small amount of water place the patch back on the clear plastic liner and store itin its original packaging TIS A Federal law restricts this device to sale by or on the order of physician or physical therapist Mul ple uses by u s1ugle putreut SAAT enr 1229 Lise by 30103 4 12 2010 ce S UI ee cE A T 290103 421212 se bw Manufazturzd by U6 7 20140 NanoVibronix Ltd 8 Derezh Hashalom St Nesher 3555 Israel Patent pending US 6 964 640 Mlanufaztured by NanoVibronix Ltd 9 Derech Hasta on St Nesher 26651 Isracl Patent pending US 76 964 640 NanoVibronix Page 16 of 21 PainShield User Manual Safety Measures This product
4. do I place the patch correctly How I can extend reusable patch usage How can I easily remove the single attachment treatment patch Can I use additional bandage for patch attachment NanoVibronix Answer No the single attachment patch 1s designed for a single attachment and can be reused for several treatments until removal The patch should never be placed on an open wound it should be placed on the health skin nearby the wound The PainShield ultrasound waves are not felt and may produce during treatment only slight warming at the Applicator site Please contact NanoVibronix local representative The user should ensure that ultrasound transducer is placed directly on healthy skin over the source of pain and the applicator 1s 1n full contact with the skin After patch removal moisten the hydro gel portion of the patch with a small amount of water place the patch back on the clear plastic liner and store it in its original packaging Do not use alcohol for reusable hydro gel patch removal Use disinfecting medical wipes to dissolve the single attachment patch adhesive Not recommended The bandage can remove hydro gel portions from the patch Page 20 of 21 PainShield User Manual Addresses Manufactured by NanoVibronix Ltd 9 Derech Hashalom St P O B 515 Nesher 36651 Israel Tel 972 4 8202994 Fax 972 4 8202794 E mail info nanovibronix com Website www nanovibronix com Com
5. ed in water or other liquid Do not place the treatment patch directly over an open wound PainShield MD device should be used by the order of a physician Following treatment some redness might occur in the treated area The redness should naturally be resolved after a couple of hours PainShield MD device should not be used while in charging mode PainShield MD device should be used only in the manner described in this User Manual The device contains rechargeable Lithium ion batteries e Do not disassemble e Do not heat above 100 C e Do not incinerate or expose device to water Treating of children should be done under adult supervision Page 7 of 21 PainShield User Manual Clinical Information Intended Use PainShield MD diathermy device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as e Pain e Muscle spasms e Joint contractures Contraindications e Cancer and bone metastases e Over bone growth centers until bone growth is complete e Directly on the eye e Directly over ischemic tissues in individuals with vascular disease Precautions e In young children it is preferable to avoid usage over the epiphyseal growth plate area e When hemorrhagic diathesis is present e Pregnant women should be treated only with physician consent NanoVibronix Page 8 of 21 PainShield User Manual General Description The Pain Sh
6. iating area of the applicator High frequency waves Megahertz range are absorbed rapidly with consequent reduction in penetration Conversely lower frequencies kilohertz range support wave penetration and may lead to greater energy deposition Applicator Ultrasound beam Transducer disk Figurel Principal schema of Ultrasound beam radiation The PainShield Device Ultrasonic diathermy 1s known to treat pain muscle spasms and to provide temporary improvement in local circulation In addition ultrasound has been used to treat post operative pain and for physiotherapy PainShield MD applies ultrasound energy through an Applicator that 1s placed at the epicenter of the pain The user may feel minor warmth at the Applicator site during the treatment period PainShield MD should be used under the prescription of a physician or physiotherapist The PainShield MD is comprised of two elements an Applicator that delivers ultrasound waves and a portable Driver unit that 1s battery operated NanoVibronix Page 4 of 21 PainShield User Manual Definitions Driver Ultra sound transducer Applicator Single attachment applicator Reusable applicator Charger NanoVibronix Electronic unit that provides the electrical signals to the transducer incorporated into the treatment patch Piezoelectric element which converts the electrical signals into ultrasound waves Treatment patch with incorporated ultrasound transduce
7. ield MD device produces low frequency low intensity ultrasonic waves for the relief of pain muscle spasm and improvement of local circulation The device includes a rechargeable battery powered driver unit that connects with a cable to an applicator The ultrasonic waves are generated by a transducer that 1s incorporated into the applicator The applicator should be placed on or next to desired treatment area For maximal effectiveness the transducer should be in full contact with the skin Two applicators are available for use Single attachment patch and Reusable patch PainShield MD device ON OFF Button lt FD 14A Reusable patch model PRP 20 Disposable patch model PDP 20 Mid cc ME ZEE Ultrasound transducer incorporated into the patch NanoVibronix Page 9 of 21 PainShield User Manual PainShield MD Operation Pre Use Preparations 1 Ensure that the driver is charged If required charge according to instruction See page 13 2 Prior to attaching the treatment patch to the skin ensure that the designated area 1s clean and dry 3 Remove excess hair from the area prior to patch application Using PainShield MD Applicator 1 Remove the protective layer from the single attachment A or reusable B treatment patch respectively The protective layer of single attachment patch can be disposed of while the layer of reusable treatment patch will be reused for storing 2 Attach the trea
8. ntil removal from the skin The reusable treatment patch is effective for 40 50 hours of use and should not be used for more than 10 treatment sessions Before storage moisten the hydro gel portion of the patch with a small amount of water Then place the patch back on the clear plastic liner Once this is done the patch can be stored in its original silver pouch Cleaning The driver unit can be wiped with disinfecting medical wipes CAUTION Do not use solvents such as acetone as they may damage the product NanoVibronix Page 18 of 21 PainShield User Manual Troubleshooting Problem Required action The battery icon on the screen 1s Low battery charging 1s required blinking and audible alarm is heard A patch icon is displayed on the Patch 1s either disconnected or non screen and audible alarm is heard functional check if the driver cable is connected correctly to the patch s snaps or replace treatment patch Before patch replacement turn the driver off The cable snaps connectors are Please contact NanoVibronix local loosened when connected to the representative patch NanoVibronix Page 19 of 21 PainShield User Manual Frequently Asked Questions Question Can I use the single attachment treatment patch again as it looks like new Can I put the patch over an open wound I do not feel anything during the treatment procedure Is the device working properly How I can order additional patches How
9. pany Address NanoVibronix Inc Broad Hollow Bioscience Park 3 Bioscience Park Drive Farmingdale NY 11735 E mail info nanovibronix com Website www nanovibronix com Representative in Europe MEDNET Gmbh Borkstrasse 10 48163 Munster Germany Tel 49 251 32266 0 Fax 49 251 32266 22 E mail info medneteurope com NanoVibronix Page 21 of 21
10. r that comes in direct contact with the treatment area Two variants are available single attachment or reusable applicator A treatment patch intended for single attachment and can be used for several treatments until removal A treatment patch intended for multiple treatments by a single patient Device for battery recharging Page 5 of 21 PainShield User Manual Symbols Class BF applied part CE CE mark Do not reuse SN Serial number Caution consult accompanying LOT udi documents 3 Rated fre quency or rated frequency Manufacturer A iones LH Separate collection for Authorized representative in the electrical and electronic European Community equipment Y Y Y Y MM DD or Used by BNR Beam non uniformity ratio Use by YYYY MM YYYY MM Power output 0 4 watts l o 0 4W ERA Effective radiating area CW Continues wave W Watts Miliwatt s per mW cn square centimeter cm Square centimeters 1W 1000mW kHz 1 Kilohertz 21000 Hz NanoVibronix Page 6 of 21 PainShield User Manual Important Notices WARNING WARNING WARNING ATTENTION ATTENTION ATTENTION CAUTION CAUTION CAUTION NanoVibronix The unit 1s classified as internally powered continuous operation ordinary equipment with a disposable type BF applied part The device 1s not intended for use in the presence of flammable mixtures PainShield MD device is not waterproof and therefore should not be immers
11. rged the on screen battery icon blinks and a beeping sound indicates that battery recharging 1s required It is advised to charge the driver prior to each use in order to assure 6 5 hours of activation 2 Turn driver off by pressing ON OFF button After 1 minute connect the charger to the driver socket and then plug the adaptor to the wall outlet Battery icon on the driver screen will indicates battery charging process Complete charging process takes approximately 5 hours When the battery 1s fully charged the on the screen battery indicator will stay constantly lit Un A U CAUTION PainShield MD should not be used while charging CAUTION Use original charger only NanoVibronix Page 13 of 21 PainShield User Manual Switch and Alarms see the device view on the page 9 The driver screen is lit the device is working properly The Patch indicator on the screen flashes and an audible alert is heard treatment patch is not connected properly or it has been damaged and should be replaced The Battery indicator on the screen flashes and an audible alert is heard low battery recharging is required The Battery indicator on the screen 1s filling up sequentially the driver is being charged The Battery indicator on the screen 1s full and lits continuously charging is completed The driver screen is not lit the driver is turned off NanoVibronix Page 14 of 21 PainShield User Manual
12. tment patch to the skin over the area where the pain 1s most intense or adjacent to the treated wound Ensure that ultrasound transducer is in full contact with the skin NanoVibronix Page 10 of 21 PainShield User Manual The patch 1s attached to the skin Treatment patch placed directly over Due to the oval shape of the transducer the location of the pain ultrasound waves mainly propagate directionally as per illustration Place the treatment patch directly over the location of the pain If skin integrity is compromised in that area place the patch on healthy skin with oval edge of the active element adjacent to the lesion see illustration 3 Connect driver cable to the treatment patch snaps 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 5 Pain Shield is active for 6 5 hours and then it shuts off automatically During treatment a screen server 1s activated For returning to normal screen press shortly the ON OFF button 6 Itis possible to shut off the device at any time by pressing the ON OFF button and hold it during 2 seconds NanoVibronix Page 11 of 21 PainShield User Manual The single attachment patch can be used as long as the patch remains adherent to the treatment area Before each treatment connect the cable to the patch snaps After the patch has been removed it should be disposed of Never pull the single use patch a
13. was designed and manufactured to ensure maximum safety of operation It should be operated and maintained in strict compliance with the safety precautions warnings and operating instructions contained in this manual The product in whole or in part shall not be modified in any way No part should be replaced with components or parts other then the originals supplied by NanoVibronix PainShield MD is a stand alone device and should not be connected to any other device system except to its own accessories CAUTION Cleaning of the device should not take place during charging CAUTION Servicing repairs and opening of the device may be carried out only by authorized distributors Product classification Low risk device classification CE mark Class II a FDA clearance class II Compliance with standards IEC 60601 1 2001 IEC 60601 2 2001 ISO 10993 NanoVibronix Page 17 of 21 PainShield User Manual Storage and Maintenance Store PainShield MD device under the following conditions Temp 0 40 C Humidity 20 85 The driver is flame resistant according to UL 94HB It does not contain flammable materials and will not accelerate a fire The driver is not intended for use in the presence of flammable mixtures Patch Shelf life According to expiration date printed on the patch package label Operational period The Driver is intended undergo up to 300 charging cycles The single attachment treatment patch can be reused u
14. way from the skin by pulling on the cable To remove the patch first disconnect the cable snaps from the patch and then gently remove the patch from the skin using alcohol to dissolve the adhesive The reusable patch may be used multiple times due to a hydro gel adhesive that may be refreshed Gently moisten the hydro gel portions of the patch using water before storage It should then be placed back on the transparent protective layer Once this 1s done the patch can be stored in its original silver pouch PainShield MD user interface screens Product name 1 Driver turned on PainShield Ver 23 03 Pro oram Version Battery level Treatment cycle number Treatment time within the cycle 2 Active mode 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 saver 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 pressing the ON OFF button and hold it during 2 seconds 3 IDLE mode 4 Battery is discharged and requires charging NanoVibronix Page 12 of 21 PainShield User Manual 5 Treatment patch is disconnected or damaged 6 Charging in progress 7 Driver 1s turning off Charging the PainShield MD driver 1 When the battery is discha
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