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NEXALIN ADI, Руководство по эксплуатации

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Table of Contents 

SECTION 1 

The Nexalin ADI Device ..................................................................................................................5 
Intended Use ..................................................................................................................................5 
Contraindications ...........................................................................................................................5 
Warnings and Limitations ..............................................................................................................5 
Possible Adverse Side Effects  ........................................................................................................6 
Explanation of Symbols ..................................................................................................................7 

SECTION 2 

Nexalin ADI Device Specifications ..................................................................................................8 
Applicable Standards .....................................................................................................................8 
Electrical .........................................................................................................................................8 
Environmental ...............................................................................................................................8 
Mechanical .....................................................................................................................................8 

SECTION 3

The Nexalin ADI System .................................................................................................................9 
Nexalin Electrodes .........................................................................................................................9 
Nexalin ADI Device Setup ...............................................................................................................9 

SECTION 4 

Nexalin ADI System Operations ...................................................................................................10 
Instructions for the Patient ..........................................................................................................10 
Powering On the Nexalin ADI Device............................................................................................10 
Preparing the Patient ...................................................................................................................11 
Applying the Nexalin Electrodes ..................................................................................................11 
Attaching the Nexalin Electrode Clips ..........................................................................................12 
The Nexalin ADI Therapy Session .................................................................................................12 
Completing the Nexalin ADI Therapy Session ..............................................................................12 
Pause Mode .................................................................................................................................12 
Default Nexalin ADI Device Parameters .......................................................................................13 
Nexalin ADI Device Status Indications .........................................................................................14 
Check Electrode LED.....................................................................................................................14 
Battery LED...................................................................................................................................15 
System Error LED .........................................................................................................................16 
Error Code 9 .................................................................................................................................16 
All Other Error Codes....................................................................................................................17 

Содержание ADI

Страница 1: ...i Bob OPERATING INSTRUCTIONS Nexalin ADIDevice Nexalin Support Center 1776 Yorktown Ave 550 Houston TX 77056 Telephone 714 916 9290 Website www nexalintechnology com The Future of Brain Based Health ...

Страница 2: ...n ADI Device is manufactured by Nexalin Technology Inc and marketed by Nexalin Technology Inc for exclusive use at Nexalin Advanced Therapy Centers Document Number IFU 7006 00 Part Number KS09003 Rev 01 Copyright July 2013 by Nexalin Technology Inc 1776 Yorktown Ave 550 Houston TX 77056 All rights reserved No part of this document may be reproduced by any means with out the prior written permissio...

Страница 3: ... Electrodes 9 Nexalin ADI Device Setup 9 SECTION 4 Nexalin ADI System Operations 10 Instructions for the Patient 10 Powering On the Nexalin ADI Device 10 Preparing the Patient 11 Applying the Nexalin Electrodes 11 Attaching the Nexalin Electrode Clips 12 The Nexalin ADI Therapy Session 12 Completing the Nexalin ADI Therapy Session 12 Pause Mode 12 Default Nexalin ADI Device Parameters 13 Nexalin A...

Страница 4: ... 18 Cleaning the Nexalin ADI System 18 SECTION 6 Nexalin ADI Device Accessories 19 SECTION 7 Limited Warranty and Expected Life 19 Nexalin ADI Device Returns 19 Contact Information 20 Disposal of the Nexalin ADI System Products 20 This Space Intentionally Left Blank ...

Страница 5: ...ese operating Instructions will help to ensure that a safe and effective treatment is administered Intended Use The Nexalin ADI Device is classified as cranial electrotherapy stimulation CES device Its intended use is for relief from the symptoms associated with anxiety depression and insomnia The Nexalin ADI Device is intended for use by or on the order of a licensed healthcare practitioner Only ...

Страница 6: ...es personal music players radios televisions or other electronic equipment Mobile phones may not be turned on anywhere in the clinic area To reduce risk of electric shock NEVER open the cover of a Nexalin ADI Device NOTE UL 60601 1 standard rating as Class I protection against electric shock Do not use a Nexalin ADI Device in the presence of flammable anesthetics Use only Nexalin Certified Electro...

Страница 7: ...o avoid a potential problem ATTENTION Indicates an area of the operating instructions that requires special attention 1A 250 FUSE AMPERAGE INDICATOR EQUIPOTENTIAL GROUND Used by equipment requiring a common ground This symbol appears on the tip of the ground stud on the back of a Nexalin ADI Device ATTENTION CONSULT ACCOMPANYING DOCUMENTS ELECTRICALLY ISOLATED FLOATING PATIENT CONNECTION TYPE BF P...

Страница 8: ... that interference will not occur in a particular installation Electrical Nexalin ADI Device power source 100 240 V 50 60Hz 0 6A Fuses Two 5 x 20 mm Slo Blo 1 0A 250V double pole neutral Power cord rating 250V AC 10A 3 wire 18AWG Type SJT grounding type IEC 60320 C13 NEMA 5 15P hospital grade plug cap 3m 9ft long UL and CSA approved Only cords with the above rating assure grounding reliability whe...

Страница 9: ...ed from the patient s head for any reason All Nexalin Electrodes must be stored in a temperature controlled environment and out of direct sunlight The Nexalin Electrodes are specifically designed to be compatible with the Nexalin ADI System To ensure the safety and effectiveness of the Nexalin ADI Therapy use only Nexalin Electrodes approved by the manufacturer Nexalin ADI Device Setup Ground Stud...

Страница 10: ...er should be connected to a technician s location is best b Providing a bell or other ringer that can be heard at the technician s desk can also be an opiton b Show them how in an emergency they can simply remove the cable hold it in hand and leave the treatment area 7 Instruct the patient to gently press on any electrode that begins to come loose during a treatment 8 Inform the patient audible to...

Страница 11: ...e back panel to discharge any static electricity 2 Arrange the patient cable across the back of the patient s shoulders with the electrode clips hanging across each shoulder 3 Open a Nexalin Electrode Set and remove one forehead and two mastoid electrodes 4 Peel the hard plastic backing off of one mastoid electrode 5 Apply the mastoid electrode to the patient avoiding the crease behind the patient...

Страница 12: ...sh the start button a second and third time as needed 8 If a break is needed by the patient you can simply disconnect the cable leading to the Nexalin device and hand it to the patient who then can do what they may need to do and return 9 Upon their return you will simply put the cable back into the Nexalin Device and hit the start button Figure 10 CURRENT LEVEL window readout Figure 11 TIME windo...

Страница 13: ...from zero to 4 00 over a period of approximately 20 to 30 seconds 5 The session TIME will resume counting down and the therapy session will continue Default Nexalin ADI Device Parameters 1 The default CURRENT LEVEL for the Nexalin ADI Device is 4 00 mA This is not adjustable 2 The default therapy session TIME for the Nexalin ADI Device is 40 00 minutes This is not adjustable CAUTION To ensure the ...

Страница 14: ...ith the patient for a minimum of 30 seconds after beginning a treatment This will allow an adequate amount of time to ensure that no electrode problems exist A Verify that the Nexalin Patient Cable Electrode Clips are properly attached to the electrodes and the device Section 4 Attaching the Nexalin Patient Cable Wait approximately 5 to 10 seconds for the light to stop flashing Once the CHECK ELEC...

Страница 15: ...y session already in progress If the internal backup battery of the Nexalin ADI Device is in use the amber BATTERY LED will light up or flash depending upon the situation Do not initiate a new Nexalin ADI Therapy session with a Nexalin ADI Device displaying a lit or flashing BATTERY LED BATTERY LED is on but not flashing The device is operating on the backup battery BATTERY LED is flashing The dev...

Страница 16: ...w it means The allowed number of Nexalin ADI Therapy sessions has been reached or The expiration date of the Nexalin ADI Device has passed and the device has been de activated and will no longer function 1 Ensure the patient is disconnected from the Nexalin ADI Device 2 Power off the Nexalin ADI Device using the ON OFF switch 3 Contact the Nexalin Support Center for assistance For support contact ...

Страница 17: ...ADI Device is properly plugged into a functioning power source 4 Wait approximately ten seconds then power the device on 5 Upon powering on the Nexalin ADI Device will perform the diagnostic self test 6 The powering on process has successfully completed when the CURRENT LEVEL window reads 4 00 and the session TIME window reads 40 00 If the error code persists the device must be returned to the man...

Страница 18: ... your hands thoroughly before cleaning or disinfecting the Nexalin ADI Device and or its accessories 4 Use a generic disinfectant cleaning agent to clean and disinfect the Nexalin ADI Device and system accessories as needed 5 Spray the disinfectant cleaner on a clean cloth or paper towel until the towel is moistened or use a pre moistened disinfectant towelette 6 Thoroughly wipe down the patient c...

Страница 19: ...ION 7 Limited Warranty and Expected Life The expected life of the Nexalin ADI Device is five 5 years from the date of original manufacture The Nexalin Patient Cable is not warranted however the expected life of the Nexalin Patient Cable is one 1 year from the date of first use The Nexalin Electrodes are not warranted and have a shelf life of three 3 years from the date of original manufacture prov...

Страница 20: ...fe return it to Nexalin Technology Inc See Section 7 Nexalin ADI Device Returns for return instructions 2 Other Nexalin ADI System components must be disposed of in accordance with federal state and local regulations These components include Forehead electrodes Mastoid electrodes Patient cables Electrode clips Power cords Nexalin Support Center Telephone 714 916 9290 Website www nexalintechnology ...

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