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NanoVibronix PAINSHIELD MD, User Manual

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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.

Emissions test

Compliance

Electromagnetic 
environment - guidance

RF emissions 
CISPR 11

Group 1

The PainShield

®

 D uses RF 

energy only for its internal 
function. Therefore, its 
RF emissions are very low 
and are not likely to cause 
any interference in nearby 
electronic equipment.

RF emissions 
CISPR 11 

Class B

The PainShield

®

 is suitable 

for use in all establishments, 
including domestic 
establishments and those 
directly connected to the 
public low- voltage power 
supply network that supplies 
buildings used for  
domestic purposes. 

Harmonic 
emissions IEC 
61000-3-2

Class A

Voltage 
fluctuations/
flicker emissions 
IEC 61000-3-3

Complies

9.1

Electromagnetic C

ompliance

9

Summary of Contents for PAINSHIELD MD

Page 1: ...1 User Manual USA ...

Page 2: ...43 442 524 M 31 6 516 536 26 F 31 343 442 162 office CEpartner4U com info nanovibronix com www nanovibronix com 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 ...

Page 3: ...ycle 5 2 Battery Operation 6 0 PRODUCT CARE 6 1 Storage 6 2 Environmental Operating Conditions 6 3 The Driver 6 4 The Actuator 6 5 The Patch 7 0 OPERATION 7 1 Charging the PainShield Driver 7 2 Preparing the Treatment Area 7 3 Preparing the Actuator and Patch for Use 7 4 Applying Therapy 7 5 PainShield Displays 7 6 Removing the Actuator Patch 7 7 Replacing the Actuator 7 8 Troubleshooting 8 0 FREQ...

Page 4: ... as a next generation wearable ultrasound system which transforms conventional therapeutic ultrasound technology into a small and portable ultrasound therapy unit It is designed to work along with the human body and maximise the safe and effective delivery of a long duration therapeutic effect PainShield is simple to use and operates on a broad range of body areas allowing the delivery of ultrasou...

Page 5: ... and operating instructions before attempting to operate the PainShield This user manual should be retained for future reference PRESCRIPTION USE ONLY Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the state in which he she practices to use or order the use of the device CONTENTS The PainShield MD includes the following items PainShield Driver...

Page 6: ...d 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 Muscle spasms Joint contractures ...

Page 7: ...erials or liquids PainShield is classified as an internally powered intermittently operated ordinary equipment with a disposable type BF applied part Do not immerse any part of PainShield in water or any other liquid Refer to Appendix A for information on maintaining basic safety with regard to electromagnetic disturbances of PainShield The PainShield is not MRI compatible and therefore should be ...

Page 8: ... aware of the actuator cable which can get caught or wrapped around a person s body and lead to potential injury or restrict blood flow Use of PainShield adjacent to or stacked with other equipment should be avoided as it could result in improper operation If such use is necessary observe the PainShield system to verify it is operating normally Use of accessories transducers and cables other than ...

Page 9: ... area Use caution when removing the actuator patch from the skin after use The safety and effectiveness of PainShield has not been established in patients who are or have been treated by other medical devices including but not limited to Pacemakers Electrical stimulators Radiofrequency generators Surgical meshes Intra Uterine devices IUDs Other surgical implants When the actuator is applied in a l...

Page 10: ...ainShield has three components A Treatment Actuator Adhesive Patches and a Driver A charger is also included 1 3 4 5 2 1 Driver 2 Actuator 3 Charger 4 Power Button 5 Adhesive Patch The PainShield System 4 0 ...

Page 11: ...ric signals to ultrasound waves For effective treatment the transducer must be in full contact with the skin PAINSHIELD ADHESIVE PATCHES The adhesive patches secure the actuator to the affected area THE PAINSHIELD DRIVER The driver that supplies electrical signals to the actuator It has the following parts Built in rechargeable battery Charging port Actuator port ON OFF button Operation screen dis...

Page 12: ...isplayed as C1 to C6 and automatically switches to OFF mode after 6 5 hours The battery should be recharged following use BATTERY OPERATION Powered by a rechargeable lithium ion battery PainShield can provide approximately 6 5 hours of continuous therapy on a single battery charge After 6 5 hours PainShield automatically switches off and the battery must be recharged You can switch PainShield to O...

Page 13: ...ommended environmental operating conditions are 0 5 40 c 10 80 70 106 kPa 5 35 c 10 80 70 106 kPa 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C 80 10 5 C 40 C 106kPa 70kPa 5 C 35 C ...

Page 14: ...e materials and will not accelerate a fire The driver is not intended for use in the presence of flammable liquids 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 THE ACTUATOR It is recommended to replace...

Page 15: ...first use remove the driver from its packaging and place on charge To charge the driver 1 Connect the USB C plug of the supplied charger to the driver s charging port 2 Plug the charger into a mains power outlet When the driver begins to charge the screen lights up brightly and displays the battery icon After approximately 1 minute the screen dims To refresh the display briefly press the ON OFF bu...

Page 16: ...adherence of the actuator patch PREPARING THE ACTUATOR AND PATCH FOR USE 1 Remove the actuator from it s packaging and connect the actuator plug into the driver socket ensuring the plug is correctly orientated in relation to the socket and make sure the plug is fully inserted and secured fig 1 7 2 7 3 1 3 4 fig 1 2 Take adhesive patch Remove the protective layer from an adhesive pad taking care to...

Page 17: ...ration 7 3 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 4 3cm 5 10cm 1 3 5 2 fig 2 fig 3 ...

Page 18: ... the pain is most intense fig 4 5 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 Be sure to place the actuator within 10cm 4 inches of the affected area to ensure the pain source is within the treatment area fig 4 ...

Page 19: ...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 To switch the driver OFF Press and hold the ON OFF button until you hear the shut off beep 7 4 Operation 7 ...

Page 20: ...C1toC6 3 Output power 4 Time elapsed since the beginning of the current ACTIVE phase Screensaver In Charging Mode The display is dimmed and keeps scrolling vertically To refresh the display of information press the ON OFF button for less than 2 seconds Screensaver In Working Mode Automaticallyreplacestheinformation screen after 3 sec PainShield is ON To refresh the display briefly press the ON OFF...

Page 21: ... Use caution when removing the actuator patch from the skin 2 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 7 6 Operation 7 ...

Page 22: ...revent the driver from sounding an alert when it is disconnected from the actuator 2 Hold the driver in one hand and the actuator cable plug in the other hand and pull apart fig 6 3 1 3 4 5 2 fig 6 fig 7 3 Connect the new actuator cable plug into the driver socket making sure to orient the plug correctly in relation to the socket and that the plug is fully inserted and secured fig 7 7 8 7 Operatio...

Page 23: ...7 1 Issue or Problem The screen displays actuator disconnection status icon and an audio alert is played TROUBLESHOOTING Issue or Problem 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 Solution Turn off ...

Page 24: ... ultrasound gel with the PainShield Question Can I put the actuator over an open wound Answer The actuator should never be placed on an open wound it should be placed on healthy skin near the wound Question Will I feel any vibrations or shocks from PainShield when it is on Answer Other than mild warmth from the metal active element in the actuator you will feel no vibrations or shocks Following tr...

Page 25: ...es that are in spasm and by normalizing nerve activity 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 PainShield is perfectly suited for use in conjunction with a program of physical therapy and can be used in between therapy sessions Frequently Asked Questions 8...

Page 26: ...Appendix ...

Page 27: ...1 Group 1 The PainShield D uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The PainShield is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies ...

Page 28: ...EC 61000 4 5 1 kV line to line 2 kV line to earth 1 kV line to line Class II ME equipment Mains power quality should be that of a typical commercial or hospital environment Voltage dips and interruptions on power supply input lines IEC 61000 4 11 0 UT for 0 5 cycle 0 UT for 1 cycle 70 UT for 25 30 cycles 0 UT for 250 300 cycles 0 UT for 0 5 cycle 0 UT for 1 cycle 70 UT for 25 30 cycles 0 UT for 25...

Page 29: ... to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz and amateur bands 1 8 MHz to 2 0 MHz 3 5 MHz to 4 0 MHz 5 3 MHz to 5 4 MHz 7 MHz to 7 3 MHz 10 1 MHz to 10 15 MHz 14 MHz to 14 2 MHz 18 07 MHz to 18 17 MHz 21 0 MHz to 21 4 MHz 24 89 MHz to 24 99 MHz 28 0 MHz to 29 7 MHz and 50 0 MHz to 54 0 MHz V 3 Vrms V 6 Vrms Proximity fields from RF wireless communicati...

Page 30: ...chargeable 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 Weight Approximately 85 g Housing ABS Acoustic power 0 4 W Frequency 90 kHz 0 001 kHz Beam Non Uniformity Ratio BNR 6 1 Effective Radiating Area ERA 6 cm Dimensions 35 mm L x 27 mm W x 6 mm D Weight Approximately 12 g Reuse 30 applications 9 2 Specifications 9 ...

Page 31: ... 2 9 2 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 Product classification Low risk device classification CE Mark Class IIa FDA Clearance Class II Classification Compliance Specifications 9 ...

Page 32: ...ether 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 Consult your municipal authority or your dealer for information about disposal Manufacturer Date of Manufacture YYYY MM DD CE Mark Authorized representative in the European Community Part number LOT Serial Number Power output 0 4 watts Beam...

Page 33: ...entimeter 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 Symbols Index 9 ...

Page 34: ...panied by a notice that describes the nature of the problem This warranty shall not apply to a product which has been subject to misuse unauthorized use negligence or accident including but not limited to fire water explosion smoke or vandalism or which has not been operated in compliance with NanoVibronix instructions for use Without derogating from the above this warranty is void if at any time ...

Page 35: ...Notes ...

Page 36: ...20 100 0004 Ver 06 info nanovibronix com www nanovibronix com 2021 NanoVibronix ...

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