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Caution: Federal law restricts this device to sale by or on the order of a physician

User Manual

Содержание NeuroSigma

Страница 1: ...Caution Federal law restricts this device to sale by or on the order of a physician User Manual...

Страница 2: ...s 3 II Contraindications Warnings and Precautions 5 III Indications For Use 8 IV Trigeminal Nerve Stimulation Therapy 8 V General Description 9 VI Monarch Key Functions 11 VII Operating Procedures 13...

Страница 3: ...eference VIII Maintenance and Cleaning 21 IX Environmental Specifications 23 Manufacturer s Declaration Electromagnetic Emissions 23 Manufacturer s Declaration Electromagnetic Immunity 24 Recommended...

Страница 4: ...ions Caution Pay special attention to the following details or consult accompanying documents Type BF Applied Part By order of a physician not applicable in the EU Manufacturer Conformit Europ enne Eu...

Страница 5: ...ed Authorized representative in the European community Serial number Do not reuse Refer to instruction manual Operating instructions Product number Lot number Unsafe within the magnetic resonance envi...

Страница 6: ...ulin pumps and t VNS within 100cm of RFID readers or emitters that operate below 150kHz in the presence of the following sources of radio frequency RF energy MRI Diathermy Cell phones CT Microwave or...

Страница 7: ...with the eTNS system compared to subjects treated with the sham placebo device Patients should consult their physician if any of the following events are observed Bronchitis Headache Itching Lighthea...

Страница 8: ...be used in the bath or shower not be used while operating machinery The Monarch electric patches should not be used in patients with dermatitis or sensitive skin as they are at higher risk of developi...

Страница 9: ...on from the face into the brain External trigeminal nerve stimulation eTNS uses this natural pathway to send therapeutic signals into the brain The trigeminal nerve connects directly from the face to...

Страница 10: ...branches of the trigeminal nerve located just below the skin above the eyebrows via a cutaneous electric patch Main component Monarch external pulse generator 1 LCD Screen 2 Output Ports CH1 CH2 3 Up...

Страница 11: ...volt batteries 2 NeuroSigma battery recharging station 1 NeuroSigma battery recharging station AC adapter 1 Belt clip 1 Monarch User Manual 1 Monarch carrying case 1 Use only NeuroSigma approved acce...

Страница 12: ...selected item from blinking Returns screen to selection mode if ERR is displayed Up and Down keys These keys are for setting or changing the current amplitude intensity in 0 2 mA increments Keeping th...

Страница 13: ...inued Lock key Pressing the Lock key locks all the keys except the Lock key itself will be displayed at the top of the LCD screen To unlock press the Lock key for two seconds or longer ON OFF key This...

Страница 14: ...ry into charging station The LED light will glow red when the battery is charging Charging a battery can take up to one hour If the LED light flashes red or green then this battery cannot be charged a...

Страница 15: ...lose the battery cover and return the retainer to its original closed position If the low battery symbol appears replace with a fully charged battery Use of a partially charged battery may cause the M...

Страница 16: ...soap and water or an alcohol based cleaning pad Completely dry the skin Remove electric patch from the release liner backing Using a mirror center the patch on the forehead and apply just above the e...

Страница 17: ...Connect electric patch wires to the lead wires Place wires above and over the ears Insert lead wire plug into one of the two output ports CH 1 or CH 2 of the Monarch Be sure the lead wire is securely...

Страница 18: ...T key Be sure the lead wire is connected to the selected output port Press the UP key to increase current amplitude to maximum tolerable level Stimulation should not be painful or uncomfortable Once t...

Страница 19: ...or to and following the use of the device Clinical trials suggest that a clinical response to eTNS should be seen within 4 weeks Limited long term data is available Once a clinical response is achieve...

Страница 20: ...a low current amplitude If the sudden stimulus continues stop using the Monarch and contact your physician immediately The message ERR will appear at the top of the LCD screen when the Monarch detect...

Страница 21: ...en press the ON OFF key If the Monarch does not turn on remove the battery and insert a fully charged battery Press the ON OFF key again If there are recurrent device turn offs contact your physician...

Страница 22: ...clean the device while in use Do not make any alterations or repairs to the Monarch or to any of the components in the eTNS System as this may result in personal injury damage to equipment and voiding...

Страница 23: ...e that interference will not occur in any particular installation If this equipment does cause interference to other devices try to correct the interference by one or more of the following measures Re...

Страница 24: ...ed The Monarch eTNS System is intended for use in the electromagnetic environment specified in the following tables The customer or the user of the Monarch should assure that it is used in such an env...

Страница 25: ...Not applicable There is no connection to a c mains Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth Not applicable There is no connection to a c mains Voltage dips short interruptions a...

Страница 26: ...hould be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency...

Страница 27: ...of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 12...

Страница 28: ...onarch main unit 5 years Components e g electric patches are consumables Error functions Battery error and open error only Battery life Approximately 15 hours at standard clinically useful settings Li...

Страница 29: ...tons except itself Lock button Press for two seconds to unlock Input code password Restricts use for intended patient XII Environmental Conditions Operating environment 10 C to 40 C 30 to 75 700 to 10...

Страница 30: ...provement CGI I 3 scale also demonstrated that a large majority of subjects improved in their overall clinical conduction Specifically at Week 4 and 8 64 and 71 of subjects respectively were assessed...

Страница 31: ...ars range 8 13 years old Sixty five percent 65 of subjects were male and thirty five percent 35 were female The study population include White 65 Black 6 Asian 16 and Mixed Other 13 races The study po...

Страница 32: ...roup The CGI I scale results demonstrated a statistically significantly greater improvement in the active arm than the sham arm when subjects were either classified as improved based on receiving a CG...

Страница 33: ...petite 19 versus 7 skin rash 6 versus 0 and teeth clenching 13 versus 7 The between group difference for these events was not statistically significant except in the case of headache p 0 05 Weight gai...

Страница 34: ...scretion of NeuroSigma the Monarch device will either be repaired free of charge by an approved service provider or replaced To obtain warranty service go to our website www monarch etns com and compl...

Страница 35: ...esentative Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Authorized Australian Representative Emergo Australia Level 20 Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Aus...

Страница 36: ...NeuroSigma Inc 10960 Wilshire Boulevard Suite 1910 Los Angeles California 90024 USA...

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