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Cervella features a multi-color LED status indicator, which informs the user about
the status of the device as described below:

When Cervella

is Charging

When Cervella needs

to be recharged

When Cervella is

connected to the

smart device and app

When Cervella is

operating

Indicator

changes to

blinking

RED

When the battery level

drops below 20%, the

indicator changes to

RED,

and blinks 3

times every 10

seconds

Indicator changes to

GREEN

when the

device is

connected/paired

with the App and

smart device

Indicator changes to

blinking

BLUE

once the

treatment is undergoing

and the current is

flowing

Indicator color

GREEN

when

Cervella is

completely

charged

When the battery level

drops below 5%, the

LED color is alternating

RED

and

GREEN

and

blinks

Indicator is OFF when

the App is exited and

the battery level is

above 20%

Indicator color is solid

BLUE

when the device is

disconnected from the

headset or the headset

is removed from

patient’s head and there

is no current flow

TABLE 1: Cervella LED Status Indicator

Содержание Cervella

Страница 1: ...Rev 1 4 Cranial Electrotherapy Stimulator User s Manual www cervella us...

Страница 2: ...are provided for reference only Always consult your healthcare provider for individual treatment protocol Caution Federal law restricts this device to sale by or on the order of a licensed health care...

Страница 3: ...ispose in accordance with local recycling instructions 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 inter...

Страница 4: ...ADPHONES 17 Headphone Pairing 19 Active Noise Cancellation ANC 19 Charging the Headphones 19 FREQUENTLY ASKED QUESTIONS 20 Clinical 20 Operation 21 Wireless Functionality Bluetooth 23 TROUBLESHOOTING...

Страница 5: ...on within the first week Note that results may vary and are dependent on individual conditions Patient should always consult his or her healthcare provider before starting Cervella and follow the trea...

Страница 6: ...present Remove any earrings piercings hearing aids or jewelry before starting treatment Ensure that you are using conductive gel best or water to wet the contact patch area Make sure that both ear cus...

Страница 7: ...skin irritation and headaches Prolonged treatment at high current levels may cause dizziness or nausea These adverse effects are usually mitigated by reducing the current intensity level Always notify...

Страница 8: ...uetooth connection allowing patient to use the audio portion of the headset during treatment The components of the Cervella device are shown below 1 External Cardboard Box P N IND BOX 2 Cervella Crani...

Страница 9: ...th version 4 0 or above Cervella is designed to work with smart devices such as cellphones or tablets running on Apple iOS or Google Android operating systems STEP 1 Download and install the Cervella...

Страница 10: ...their parent or legal guardian perform the device registration process STEP 4 Select Pairing from the drop down menu and press Search for Cervella to enter the pairing menu Next Press Search Again If...

Страница 11: ...cannot use the Cervella stimulation while charging Bluetooth Information In order to ensure uninterrupted communication between the Cervella and your controlling smart device ensure that you keep the...

Страница 12: ...fore starting treatment Apply a layer of conductive gel or if not available water at the point of skin contact behind each ear area mastoid as circled below and also to the gold colored skin mastoid c...

Страница 13: ...of the cable connects to the Cervella port and the other end connects to the circular port under one of the ear cushions Next place the headset on patent s head and ensure that the electrodes are mak...

Страница 14: ...adjust the current intensity until you start feeling a tingling sensation Then tap the intensity bar down to reduce the intensity so the tingling sensation is barely perceptible If the tingling sensa...

Страница 15: ...seconds Indicator changes to GREEN when the device is connected paired with the App and smart device Indicator changes to blinking BLUE once the treatment is undergoing and the current is flowing Indi...

Страница 16: ...tory screen is useful as a reference for the patient during discussion with his or her health provider User Menu The User Menu shows the user s information entered during registration process User can...

Страница 17: ...PAGE 17 OF 38 Cervella Headphones...

Страница 18: ...r hang up Press and hold to reject call Voice Control Press twice to activate Siri if paired to an Apple device Music Play Control Press to play pause 6 Volume Skip Backward Press to turn volume down...

Страница 19: ...os 0000 for pass code or accept connection Once successfully paired the headphone LED indicator flashes BLUE Note Avoid connecting additional Bluetooth devices other than Cervella device and headphone...

Страница 20: ...please use Cervella at reduced intervals or on an as need basis as instructed by your healthcare provider Q What should be the optimal treatment intensity level A The optimal treatment intensity leve...

Страница 21: ...ervella A Do not operate vehicles or dangerous equipment during treatment and within several hours post treatment Q Can I use Cervella together with medication A Generally yes but always consult your...

Страница 22: ...Using Cervella at high current levels and without conductive gel or water at the contact patch interface may cause skin irritation Q Why is it that when I press START in the timer circle the timer do...

Страница 23: ...udio feature of the Cervella headphones also ensure that the audio source and the Cervella headphones are not separated by more than 15ft 5m When this range is exceeded you may see an error The connec...

Страница 24: ...t LED STAYS SOLID BLUE Current intensity is set too low Increase current intensity via the Cervella App Headset electrodes are not making a good contact with patient s head Check the position and tigh...

Страница 25: ...it the Cervella App completely then restart the App and restart the treatment If problem persists turn the Bluetooth off and on again in your smart device The Cervella LED indicator is blinks RED Cerv...

Страница 26: ...me but the indicator LED should glow RED to indicate the charging state after a while There is no sound from the headphones Check that Bluetooth headphone is charged and switched on Ensure the music s...

Страница 27: ...headphone and cell phone Bluetooth devices are turned on Make sure the headphone enters Bluetooth pairing mode the indicator blinks red and blue Try to delete the previous connected Bluetooth Cervella...

Страница 28: ...by the manufacturer In order to ensure good service life of the rechargeable battery inside the Cervella unit and the stereo headset fully charge both the device and headset at least once every six m...

Страница 29: ...nds on frequency of use charge discharge cycle and usage environment Injury caused by leak or explosion of battery may happen if the battery is broken apart or burned Battery should be replaced in the...

Страница 30: ...Pulse Width 5ms 1s The pulse width is variable and depends on frequency selection Bluetooth Version 4 0 BLE Bluetooth Frequency 2 400 GHz 2 4835 GHz ISM Band Class 2 2 5mW Bluetooth Distance Range 5m...

Страница 31: ...5ft maximum range recommended Noise Cancellation ANC Active Noise Cancellation Headphone drivers 32 40mm 100 3dB 20Hz 20kHz Stand by Time 800h Talking Time 65h Music Playing Time Max volume with ANC o...

Страница 32: ...ult in ineffective or incomplete treatment Cervella must only be used with the headset with integrated electrodes headset to device connecting cable AC DC charger and charger to device cable provided...

Страница 33: ...11 Group 1 Cervella 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...

Страница 34: ...fferential mode 2 kV common mode 1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on po...

Страница 35: ...50 kHz to 80 MHz 6 V in ISM and amateur radio bands between 0 15 MHz and 80 MHz 10 V m 80 MHz to 2 7 GHz 385MHz 5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equ...

Страница 36: ...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 b Field strengths from fixed transmitter...

Страница 37: ...may become worn or contaminated The ear cushions with treatment electrodes are designed to be easily user replaceable You can remove each treatment electrode by gently twisting the ear cushion off cou...

Страница 38: ...ng The following is the device label placed on the back of the Cervella stimulator The items in RED are unique identifiers to each device serial number date of manufacture and GUDID information in 2D...

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