THERANICA Nerivio Скачать руководство пользователя страница 37 | Manualshive

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THERANICA Nerivio Скачать руководство пользователя страница 37

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For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

Note

: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies

Note

: These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects, and people.

15. FCC RADIO FREQUENCY INTERFERENCE STATEMENT

FCC Registration Number (FRN): 0027054477.

This  equipment  has  been  tested  and  found  to  comply  with  the  limits  of  Class  B  digital
device,  pursuant  to  part  15  of  the  FCC  Rules.  These  limits  are  designed  to  provide
reasonable  protection  against  harmful  interference  in  a  residential  installation.  This
equipment generates, uses and can radiate radio frequency energy and, if not installed
and  used  in  accordance  with  the  instructions,  may  cause  harmful  interference  to  radio
communications.  However,  there  is  no  guarantee  that  interference  will  not  occur  in  a
installation.  If  this  equipment  causes  interference  with  other  devices,  which  may  be
determined by turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:

• Reorient or relocate the device receiving the interference

• Increase the separation between the equipment

• Connect the equipment into an outlet on a circuit different from that to which the device
is connected.

• Consult the manufacturer or field service technician for help

Theranica Bio-Electronics LTD. is not responsible for any radio or communication
interference caused by using other than specified or recommended cables and battery or
by unauthorized changes or modifications to this equipment. Changes or modifications not
expressly approved by the manufacturer could void the user’s authority to operate the
equipment.

This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions:

1. This device may not cause harmful interference, and

2. This device must accept any interference received, including interference that may
cause undesired operation.

16. APPLICABLE STANDARDS

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Содержание Nerivio

Страница 1: ...Nerivio A wireless non invasive neuromodulation device for the acute treatment of migraine USER MANUAL...

Страница 2: ...ced without the written permission of Theranica Theranica reserves the right to change or improve its products and accompanying technical literature without specific notice Manufacturer Theranica Bio...

Страница 3: ...ce 25 7 2 Disposal 26 8 Troubleshooting 26 8 1 General 26 8 2 Main errors and messages 27 8 3 LED status 28 8 4 Customer support 28 9 Operation specification 29 9 1 Environment operating conditions 29...

Страница 4: ...roduces electrical signals The device is good for 12 treatments of 45 minutes 2 Armband and an extension The armband should be wrapped around the device on the arm to improve the contact between the d...

Страница 5: ...tion on the arm and to conceal the device to enable a discreet treatment An extension is also provided for larger arm sizes An application app installed on a smartphone to control and monitor the trea...

Страница 6: ...mpliance with FCC Federal Communications Commission Class B certified for home use FCC identifier 2AOH8 NM Manufacturer Type BF applied part IEC60601 1 Catalog number Serial number IP22 Ingress protec...

Страница 7: ...t WEEE Directive This product must not be disposed of via municipal waste collection Separate collection for electrical and electronic equipment waste per Directive 2012 19 EC in the European Union is...

Страница 8: ...could cause electric shock electrical interference or serious injuries or medical conditions 4 2 WARNINGS PRECAUTIONS AND ADVERSE EVENTS The following icons are used throughout this user manual Warni...

Страница 9: ...to cancerous lesions Do not use the device on an arm with a metallic implant In such cases consider using it on the other upper arm Do not use the device simultaneously with another electrical stimul...

Страница 10: ...ty may occur in the vicinity of equipment emitting RF e g microwave routers Wi Fi devices To minimize moisture loss when unused the electrodes should be covered with the provided protective film and t...

Страница 11: ...ng numbness in the arm pain in the arm or redness of the skin which should disappear shortly after the end of the treatment Refer to Theranica s website at https theranica com for a complete listing o...

Страница 12: ...hone requirements Step 2 Download and install the Nerivio app via Google play or App store depending on your operating system Step 3 You will be asked to create an account Follow the app instructions...

Страница 13: ...at least 1 uppercase letter at least 1 lowercase letter and at least 1 numeric digit During the sign up process the app will send you a verification email to the email address which you have registere...

Страница 14: ...o device to the app using the app instructions The device and the smartphone should be in proximity of less than 1 inch 2 5 cm As you begin using the app it may ask for permissions Please allow these...

Страница 15: ...e it for next use or start a treatment following the instructions below If the device was on for over 10 minutes when no treatment was initiated it automatically shuts down Turn it back on to start a...

Страница 16: ...s and migraine headaches More screen This screen provides access to some of the technical aspects of the app View profile Select this to view your account details Buy Nerivio Select this to but a Neri...

Страница 17: ...lect to enter a code if applicable Sign out select this to sign out of your account 6 2 TREATING A MIGRAINE HEADACHE The treatment should be performed at the onset of a migraine headache For effective...

Страница 18: ...slow flashing mostly on green light indicates the device is on If the LED is still off or is solid green please contact customer support Step 4 Open the app and confirm the device is connected succes...

Страница 19: ...device should be located midway between the elbow and the shoulder Place the device directly on the skin and not on your shirt Step 7 Adjust the armband to your size There are 4 sizes you can choose...

Страница 20: ...s now begun and will stop automatically after 45 minutes A slow flashing mostly off green light indicates the device is stimulating Do not start a treatment before placing the device on your arm Do no...

Страница 21: ...tarts at a default intensity of 12 Gradually increase the intensity as described below Setting intensity level a Start increasing the stimulation intensity using the button Each press will increase th...

Страница 22: ...ntact customer support For your safety the intensity will increase slowly This gradual increase will be presented in the app by a flashing increasing indication that will stop once the desired intensi...

Страница 23: ...adual increase will be presented in the app by a flashing increasing indication that will stop once the desired intensity is reached The treatment can be stopped early at any time by touching the paus...

Страница 24: ...has ended the green light will turn off Step 2 Apply the protective film on the electrodes the protective film is reusable Step 3 Place the device in its original package or in the travel bag to store...

Страница 25: ...unt details To view your login details in the app touch More and then touch View profile 7 CLEANING MAINTENANCE AND DISPOSAL 7 1 CLEANING AND MAINTENANCE The device can be cleaned with a dry cloth exc...

Страница 26: ...ease check and confirm the following 1 Make sure that Bluetooth connection is enabled in your phone 2 Make sure that there are treatments left in your device 8 1 GENERAL Problem What it may mean What...

Страница 27: ...e phone Enable the Bluetooth feature on your phone and try to reconnect The phone and the device are not close enough Bring the phone closer to the device to a range of 1 inch 2 5 cm The device was au...

Страница 28: ...ice is turned off Turn on the device The device is too far from the smartphone Bring the phone closer to the device to a range of inch 2 5 cm Authentication failed The device has already been associat...

Страница 29: ...DITIONS Operating temperature range 5 to 40 C 41 F 104 F Relative humidity range 35 65 Atmospheric pressure 70 106 kPa 9 2 ENVIRONMENTAL STORAGE AND TRANSPORTATION CONDITIONS BETWEEN USES Temperature...

Страница 30: ...charge or detach the battery Recycle or dispose the device in accordance with disposal instructions in the user manual 10 TECHNICAL SPECIFICATIONS Number of channels 1 Waveform Biphasic rectangular mo...

Страница 31: ...play Device LED Via the mobile application if connected On off status Yes Yes Wireless connection Yes Yes Low battery No Yes remaining number of treatments Current level No Yes stimulation intensity O...

Страница 32: ...further control However the app may not enable you to stop the treatment or adjust the intensity which may result in an uncomfortable feeling If such sensation occurs please remove the device from yo...

Страница 33: ...h it is used Do not use devices which generate strong electrical or electromagnetic fields in proximity to the Nerivio device This may result in incorrect operation of the device and create a potentia...

Страница 34: ...ormatted based on IEC60601 1 2 2007 Electromagnetic emissions IEC 60601 1 2 Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Nerivio uses RF energy only...

Страница 35: ...Not Applicable 70 UT for 25 cycles Not Applicable 0 UT for 5 s Not Applicable Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Note UT is the A C mains voltage prior to application...

Страница 36: ...oadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field...

Страница 37: ...mful interference to radio communications However there is no guarantee that interference will not occur in a installation If this equipment causes interference with other devices which may be determi...

Страница 38: ...safety and essential performance IEC EN 60601 1 2 edition 4 0 Medical electrical equipment Part 1 2 General requirements for safety collateral standard Electromagnetic compatibility Requirements and t...

Страница 39: ...ca Bio Electronics LTD 4 Ha Omanut St Netanya 4250438 Israel Tel 972 72 3909 763 Fax 972 72 3909762 2018 Theranica Bio Electronics LTD All Rights Reserved www theranica com ART No LBL NM 0014 1 1 Rev...

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