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PainShield® MD User Manual

7

3

Safety

3.1

Contraindications

PainShield® MD is prohibited 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 centers until bone growth is complete

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Содержание PainShield

Страница 1: ...User Manual Cat 20 100 0001 Ver 03 USA...

Страница 2: ...2...

Страница 3: ...ess NanoVibronix cannot be held responsible for errors or omissions Trademarks patents and copyrights apply NanoVibronix Inc 525 Executive Boulevard Elmsford N Y 10523 USA Tel 1 914 233 3004 Fax 1 914...

Страница 4: ...duct Components 11 5 1 The PainShield MD Treatment Actuator 11 5 2 The PainShield MD Driver 12 6 Operation 13 6 1 Charging the Driver 13 6 2 Preparing the Treatment Area 14 6 3 Preparing the Actuator...

Страница 5: ...fe and effective delivery of a long duration therapeutic effect PainShield MD is simple to administer and operates on a broad range of body areas allowing the delivery of ultrasound treatment for up t...

Страница 6: ...sed 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 J...

Страница 7: ...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 diseas...

Страница 8: ...his manual Do not use any part of PainShield MD that appears damaged Do not modify PainShield MD in any way Do not replace any part of PainShield MD with components or parts other than those supplied...

Страница 9: ...piphyseal growth plate area Use caution when removing the actuator patch from the skin after use The safety and effectiveness of PainShield MD has not been established in patients who are or have been...

Страница 10: ...to OFF mode after 6 5 hours at which point the battery should be recharged 4 2 Battery Operation Powered by a rechargeable lithium ion battery PainShield MD can provide 6 5 hours of continuous therapy...

Страница 11: ...ld MD 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 ult...

Страница 12: ...2 The PainShield MD Driver The driver that supplies electrical signals to the transducer in the actuator has the following parts Built in rechargeable battery Charging port Connection cable ON OFF bu...

Страница 13: ...ver is being charged Before first use remove the driver from its packaging and verify that it is fully charged To charge the driver 1 Connect the mini USB plug of the supplied charger to the driver s...

Страница 14: ...e treatment area 2 Clean the treatment area thoroughly with soap and water or an alcohol prep pad 3 Dry the treatment area 6 3 Preparing the Actuator for Use 1 Remove the actuator from its packaging a...

Страница 15: ...ve leaving the outer strips attached to insure easy placement 3 Place the actuator on the exposed adhesive at the center of the patch with the metal transducer facing up and the wire aligned with the...

Страница 16: ...tor is within 4 inches 10cm of the effective area to insure the pain source is within the treatment area 6 4 Applying Therapy Use the ON OFF button to switch the driver ON and OFF To switch the driver...

Страница 17: ...on the screen at various times Symbols Text Displayed Explanation Manufacturer name displayed briefly when you switch ON the driver Product name Software version number displayed briefly in the interv...

Страница 18: ...wer 4 PainShield MD is in IDLE phase Screensaver during working mode automatically replaces the information screen after 3 minutes PainShield MD is ON To refresh the display of information briefly pre...

Страница 19: ...uator is damaged or not connected to the driver The driver is switching OFF Switching off takes 3 seconds The number indicates how many seconds to complete shut off 6 6 Removing the Actuator Patch 1 U...

Страница 20: ...s disconnected from the actuator 2 Hold the driver cable socket in one hand and the actuator cable plug in the other hand and then pull them apart CAUTION Never attempt to disconnect the driver from t...

Страница 21: ...n it is on Other than mild warmth from the metal active element in the actuator you will feel no vibrations or shocks Following treatment some redness might occur in the treated area This redness reso...

Страница 22: ...cal wipes Do not use solvents such as acetone as they may damage the product The driver is flame resistant according to UL 94HB It does not contain flammable materials and will not accelerate a fire T...

Страница 23: ...c emissions IEC 61000 3 2 Class B Voltage fluctuations flicker emissions IES 61000 3 3 Complies Table 2 PainShield MD Electromagnetic Immunity Guidance and Manufacturer s Declaration Electromagnetic E...

Страница 24: ...ion will not be affected by power mains interruptions since PainShield MD is battery powered During system charging it is recommended that PainShield MD be powered by an uninterruptible power supply U...

Страница 25: ...lectromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telep...

Страница 26: ...150 kHz to 80 MHz P V d 1 5 3 Separation Distance meters 80 MHz to 800 MHz P E d 1 5 3 Separation Distance meters 800 MHz to 2 5 GHz P E d 1 7 Separation Distance meters 0 01 0 12 0 12 0 23 0 1 0 37 0...

Страница 27: ...sing ABS Treatment Actuator 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 x 270 mm x 6 mm Weight 12 g Reuse Appro...

Страница 28: ...eld MD User Manual 28 Appendix C Labels Figure 1 Figure 2 Figure 3 and Figure 4 show PainShield MD labels Figure 1 Driver Label Figure 2 Actuator pouch label Figure 3 Kit label Figure 4 Patches pouch...

Страница 29: ...e collection for electrical and electronic equipment Manufacturer Temperature limits Authorized representative in the European Community LOT BNR Beam Nonuniformity Ratio S N Serial number ERA Effectiv...

Страница 30: ...urned to NanoVibronix accompanied 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 accide...

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