Innovative Neurological Devices Cervella User Manual Download Page 34

PAGE 34 OF 38

 

Guidance and manufacturer´s declaration – electromagnetic immunity 

Cervella

 is intended for use in the electromagnetic environment specified below. The customer or the user 

of the 

Cervella

 should assure that it is used in such an environment. 

Immunity test 

IEC 60601 

test level 

Compliance level 

Electromagnetic 

environment - 

guidance 

Electrostatic 
discharge (ESD) 
 

IEC 61000-4-2 

± 8 kV contact 
 
± 2 kV, ± 4 kV, ± 8 kV, 

± 15 kV air 

 
±

 

8 kV contact

 

 

± 2 kV, ± 4 kV, ± 8 
kV, 
± 15 kV air

 

 

 

Floors should be wood, 
concrete or 

ceramic tile. If floors are 
covered with synthetic 
material, the relative 
humidity should be at 

least 30 %. 

Electrostatic 
transient / burst 
 
IEC 61000-4-4 

± 2 kV for power 
supply lines 
 

± 1 kV for input/output 
lines 

 
 

±

 

2 kV for power

 

supply lines

 

 

 

 
 

Mains power quality 
should be that of a 
typical commercial or 

hospital 
environment. 

Surge 
 
IEC 61000-4-5 

 
±  1 kV differential 

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 power supply 
input lines 

 
IEC 61000-4-11 

0 % UT; 0,5 cycle g) At 0°, 45°, 
90°, 135°, 180°, 225°, 270° and 
315°  

 
0 % UT; 1 cycle and 70 % UT; 
25/30 cycles  Single phase: at 

0° 
 
0 % UT; 250/300 cycle  

0 % UT; 0,5 cycle g) 
At 0°, 45°, 90°, 

135°, 180°, 225°, 
270° and 315°  
 
0 % UT; 1 cycle and 

70 % UT; 25/30 
cycles  Single 
phase: at 0° 

 
0 % UT; 250/300 
cycle 

Mains power quality 

should be that of a 
typical commercial or 
hospital environment. If 
the user of the 

Cervella

 

requires continued 
operation during power 
mains interruptions, it is 

recommended that the 

Cervella

 be powered 

from an uninterruptible 

power supply or a 
battery. 

Power frequency 
(50/60 Hz) 
magnetic field 

 
IEC 61000-4-8 

30 A/m 

 
 
30 A/m 

 
 

Power frequency 
magnetic fields should be 

at levels characteristic of 
a typical location in a 
typical commercial or 

hospital environment. 

NOTE                 U

T  

is the a. c. mains voltage prior to application of the test level. 

Summary of Contents for Cervella

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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