Innovative Neurological Devices Cervella User manual

Rev. 1.4

Cranial Electrotherapy Stimulator

User’s Manual

www.cervella.us!

PAGE%2%OF%38%

"#$%&! '()! *(+! ,)+-#$./%0! 1#2! 32+4255$6! 3+$%/$5! 752-1+(1#2+$,'! 81/9)5$1(+:! $!%(%;

,#$+9$-(5(0/-$5! $512+%$1/42! *(+! 1+2$192%1! (*! $%</21':! =2,+2../(%:! $%=! /%.(9%/$>!

32+4255$6! *2$1)+2.!$! %)9?2+! (*! /%%(4$1/42! ,$12%1;,2%=/%0! *2$1)+2.! 1#$1! /%-+2$.2!

2$.2;(*;).2! $%=! -(9*(+1! =)+/%0! 1+2$192%1! $%=:! -(%.2@)2%15':! /9,+(42! ,$1/2%1A.!

-(9,5/$%-2>!!

B51#()0#!C2!#$42!=2./0%2=!32+4255$6!C/1#!9$</9)9!).2!./9,5/-/1'!/%;9/%=:!,52$.2!

+2$=! 1#/.! 9$%)$5! 1#(+()0#5'! ,+/(+! 1(! ).2>! B5.(:! ?2! .)+2! 1(! *(55(C! 1#2! 02%2+$5!

/%.1+)-1/(%.! ,+(4/=2=! /%! 1#/.! 9$%)$5! $%=! $%'! .,2-/*/-! =/+2-1/(%.! *+(9! '()+! #2$51#!

-$+2!,+$-1/1/(%2+>!

"#2! ,$+$9212+! .211/%0.! $%=! 1+2$192%1! 0)/=25/%2.! *(+!1#/.! =24/-2! $+2!,+(4/=2=! *(+!

+2*2+2%-2! (%5'>! B5C$'.! -(%.)51! '()+! #2$51#-$+2! ,+(4/=2+! *(+! /%=/4/=)$5! 1+2$192%1!

,+(1(-(5>!!

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

licensed%health%care%practitioner.%

NOTE:% Always% notify% your% healthcare% practitioner% immediately% if% your% health%

conditions%do%not%improve%or%if%you%experience%any%side%effects.%

D()! .#()5=! *(55(C! 1#2! /%.1+)-1/(%.! -(%1$/%2=! /%! 1#/.! 9$%)$5! /%! (+=2+! 1(! ,+242%1!

$?%(+9$5! (,2+$1/(%! 1#$1! 9$'! =$9$02! 1(! 1#2! =24/-2!$%=! +2.)51! /%! /%2**2-1/42!

1+2$192%1!(+!-$).2!,$1/2%1!=/.-(9*(+1>!E%%(4$1/42!F2)+(5(0/-$5!G24/-2.!HH3!C/55!%(1!

?2! #25=! +2.,(%./?52! *(+! /%I)+':! #$+9:! (+! =$9$02! 1(! ,2+.(%! (+! ,+(,2+1'! -$).2=! ?'!

9/.).2!(*!1#/.!=24/-2>!

Cervella™%is%a%trademark%of%INNOVATIVE%NEUROLOGICAL%DEVICES%LLC%

International%and%US%Patents%Pending.%All%Rights%Reserved.%

©%2019%INNOVATIVE%NEUROLOGICAL%DEVICES%LLC%

% %

PAGE%3%OF%38%

8DJKLH8!

"#2+2!$+2!%(!.12+/52!,$+1.!(*!1#2!32+4255$!=24/-2!(+!,$+1.!1#$1!$+2!

92$%1!1(!?2!.12+/5/M2=>!

"',2!KN!7@)/,92%1>!E%12+%$55'!,(C2+2=!(%5'>!

822! /%.1+)-1/(%.! *(+!).2>!O2$=! 1#/.! 9$%)$5! 1#(+()0#5'! ,+/(+! 1(!

)./%0!1#2!=24/-2>!

P22,!=+'>!

"#/.! ,+(=)-1! -(%1$/%.!H/;E(%! ?$112+/2.! $%=! 9).1! ?2! ,+(,2+5'!

+2-'-52=>! G(! %(1! 1#+(C! /%! 1#2! 1+$.#! C/1#! (+=/%$+'! #().2#(5=!

C$.12>!G/.,(.2!/%!$--(+=$%-2!C/1#!5(-$5!+2-'-5/%0!/%.1+)-1/(%.>!

"#/.! =24/-2! -(9,5/2.! C/1#! ,$+1! QR! (*! 1#2! N33! O)52.>! L,2+$1/(%! /.!

.)?I2-1! 1(! 1#2! *(55(C/%0! 1C(! -(%=/1/(%.S! TQU! "#/.! =24/-2! 9$'! %(1!

-$).2! #$+9*)5! /%12+*2+2%-2:! $%=! TVU! 1#/.! =24/-2! 9).1! $--2,1! $%'!

/%12+*2+2%-2! +2-2/42=:! /%-5)=/%0! /%12+*2+2%-2! 1#$1! 9$'! -$).2!

)%=2./+2=!(,2+$1/(%>!

32+4255$6! /.! $! 1+$=29$+&! (*! EFFLWB"EW7! F7XOLHLYE3BH! G7WE378! HH3>! /L8!$+2!

+20/.12+2=!1+$=29$+&.!3/.-(!$%=!5/-2%.2=!?'!B,,52!$%=!Y((052!Z5$'6!/.!$!1+$=29$+&!

*(+! 1#2! .1(+2! (*! Y((052>!K5)21((1#® 1+$=29$+&.! $+2! (C%2=! ?'! K5)21((1#! 8,2-/$5!

E%12+2.1!Y+(),!T8EYU>!%!

PAGE%4%OF%38%

"BKH7!LN!3LF"7F"8!

SYMBOLS% 3!

TABLE%OF%CONTENTS% 4!

PRINCIPLE%OF%OPERATION% 5!

INDICATIONS% 5!

CONTRAINDICATIONS% 6!

PRECAUTIONS% 6!

ADVERSE%EVENTS% 7!

CERVELLA%DESCRIPTION% 8!

CERVELLA%APP%SET-UP% 9!

Cervella'Battery'Level!...............................................................................................................................................!11!

Bluetooth'Information!..............................................................................................................................................!11!

CERVELLA%OPERATION%12!

Home'Menu!..............................................................................................................................................................!14!

Treatment'History!.....................................................................................................................................................!16!

User'Menu!.................................................................................................................................................................!16!

CERVELLA%HEADPHONES%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%24!

Cervella'Troubleshooting!..........................................................................................................................................!24!

Stereo'Headset'Troubleshooting!..............................................................................................................................!26!

CERVELLA%CARE%28!

Cleaning'Instructions!................................................................................................................................................!28!

Batteries'and'Power'Supplies!...................................................................................................................................!29!

TECHNICAL%SPECIFICATIONS%30!

Cervella'Device!..........................................................................................................................................................!30!

Headphones!..............................................................................................................................................................!31!

ELECTROMAGNETIC%EMISSIONS%AND%IMMUNITY%32!

WARRANTY%AND%SERVICE%INFORMATION%37!

COMPANY%CONTACT%INFORMATION%37!

DEVICE%LABELING%38!

PAGE%5%OF%38%

Z+/%-/,52!(*!L,2+$1/(%

32+4255$! C(+&.! ?'! .2%=/%0! 9/-+(! ,)5.2.! (*! 252-1+/-/1'! 1(! '()+! ?+$/%! 4/$! 252-1+(=2.!

/%120+$12=! /%1(! 1#2! 2$+! ,$=.!(*! 1#2! .12+2(! #2$=.21>! B--(+=/%0! 1(! -5/%/-$5! $%=!

+2.2$+-#!.1)=/2.:!1#2! 9/-+(!-)++2%1!#$.!.242+$5!2**2-1.!(%!1#2! ?+$/%S!/1!$**2-1.! 1#2!

G2*$)51! J(=2! F21C(+&! TGJFU:! $512+.! 2%=(02%().! ?+$/%! (.-/55$1/(%.:! $%=! #$.! $%!

2**2-1!(%!1#2!-#$%02!(*!%2)+(1+$%.9/112+!52425.!.)-#!$.!.2+(1(%/%>!"#2!2**/-$-'!$%=!

92-#$%/.9.! (*! $-1/(%! (*! -+$%/$5! 252-1+(1#2+$,'! .1/9)5$1/(%! *(+! 1+2$192%1! (*!

$%</21':! /%.(9%/$:! $%=! =2,+2../(%! $+2! =29(%.1+$12=! $%=! =(-)92%12=!1#+()0#! $!

%)9?2+! (*! -5/%/-$5! 1+/$5.!$%=! +2.2$+-#! ,$,2+.>! [2! 2%-()+$02! '()! 1(! 4/./1! ()+!

C2?./12! TCCC>-2+4255$>).U! *(+! $! .)99$+'! 5/.1! (*! ,)?5/-5'!$4$/5$?52! -5/%/-$5! $%=!

+2.2$+-#!/%*(+9$1/(%>!

J(.1!,$1/2%1.!.1$+1!*225/%0!1#2!,(./1/42!2**2-1.!(*!-+$%/$5!252-1+(1#2+$,'!.1/9)5$1/(%!

C/1#/%!1#2!*/+.1!C22&>!F(12!1#$1!+2.)51.!9$'!4$+'!$%=!$+2!=2,2%=2%1!(%!/%=/4/=)$5!

-(%=/1/(%.>! Z$1/2%1! .#()5=!$5C$'.! -(%.)51! #/.! (+! #2+!#2$51#-$+2! ,+(4/=2+! ?2*(+2!

.1$+1/%0! 32+4255$! $%=! *(55(C! 1#2! 1+2$192%1! ,5$%! $.! =/+2-12=>! B%</21'! /.! (*12%!

+2=)-2=!$*12+!$!./%052!1+2$192%1!?)1!9$'!+2(--)+!.(!-(%./.12%1!1+2$192%1!.2../(%.!

$+2!+2-(992%=2=>! J$%'! ,$1/2%1.! .)**2+/%0! *+(9! $%</21'! */%=! /1! ).2*)5! 1(! ).2!

32+4255$! $1! 1#2! (%.21! (*! $%</21'! (+! ?2*(+2! $! #/0#! .1+2..! ./1)$1/(%>! Z$1/2%1.! C/1#!

=2,+2../(%! C/55! (*12%! .22! /9,+(4292%1.! /%! $! *2C! C22&.:! ?)1! ,$1/2%1.! .#()5=!

-(%1/%)2!1(!).2!32+4255$!$.!=/+2-12=!?'!1#2/+!#2$51#-$+2!,+(4/=2+>!E%.(9%/$!/.!(*12%!

+2=)-2=! $*12+! $! ./%052! 1+2$192%1! ?)1:!5/&2! /%! 1#2! -$.2! (*! =2,+2../(%:! -(%./.12%1!

1+2$192%1! .2../(%.! $+2!+2-(992%=2=! 242%! C#2%! '()! $+2! *225/%0! ?2112+>! [#2%!

-(%=/1/(%.!/9,+(42:!,52$.2!).2!32+4255$!$1!+2=)-2=!/%12+4$5.!(+!(%!$%!$.;%22=!?$./.!

$.!/%.1+)-12=!?'!'()+!#2$51#-$+2!,+(4/=2+>!

E%=/-$1/(%.!

32+4255$! -+$%/$5! 252-1+(1#2+$,'! .1/9)5$1(+! /.! /%=/-$12=! *(+! 1+2$192%1! $%=!

9$%$0292%1!(*!$%</21':!/%.(9%/$:!$%=!=2,+2../(%>!!

PAGE%6%OF%38%

3(%1+$/%=/-$1/(%.!

"#2+2! $+2! %(! &%(C%! -(%1+$/%=/-$1/(%.! *(+! ).2! (*! 1#2! 3+$%/$5! 752-1+(1#2+$,'!

81/9)5$1(+>!\(C242+:!1#2+2! $+2!-(%=/1/(%.!C#2+2!1#2!).2!(*!$!378!=24/-2!#$.!%(1!

?22%!12.12=>!3(%.2@)2%15':!32+4255$!.#()5=!%(1!?2!).2=!?'!,$1/2%1.!C/1#!/9,5$%12=!

92=/-$5!=24/-2.!.)-#!$.!,$-29$&2+.:!/9,5$%12=!=2*/?+/55$1(+.!(+!921$5!/9,5$%1.!/%!

#2$=! (+! %2-&>! 8$*21'! (*! .1/9)5$1/(%! #$.! %(1! ?22%! 2.1$?5/.#2=! =)+/%0! ,+20%$%-'>!

7,/52,.'! ,$1/2%1.! .#()5=! %(1! ?2! )./%0! 1#2! =24/-2! C/1#()1! -5/%/-$5! .),2+4/./(%>!

B5C$'.!-(%.)51!'()+!#2$51#-$+2!,+(4/=2+!?2*(+2!)./%0!32+4255$>!

Z+2-$)1/(%.!

• N(+!2<12+%$5!).2!(%5'>!G(!%(1!).2!1#/.!=24/-2!*(+!(1#2+!,)+,(.2.!(1#2+!1#$%!

/%=/-$12=!/%!1#/.!9$%)$5>!

• Children% should% not% be% allowed% to% use% the% Cervella% device% without% adult%

supervision.%%

• G(! %(1! ).2! (42+! .&/%! 52./(%.:! *+2.#! -)1.:! .-$+.:! $%=! C#2%! .&/%! /++/1$1/(%! /.!

,+2.2%1>!!

• O29(42! $%'! 2$++/%0.:! ,/2+-/%0.:! #2$+/%0! $/=.:!(+! I2C25+'! ?2*(+2! .1$+1/%0!

1+2$192%1>!!!

• 7%.)+2!1#$1!'()!$+2!)./%0!-(%=)-1/42!025!T?2.1U!(+!C$12+!1(!C21!1#2!-(%1$-1!

,$1-#!$+2$>!J$&2!.)+2!1#$1!?(1#!2$+!-).#/(%.!$+2!/%!1/0#1!-(%1$-1!C/1#!'()+!

.&/%!$%=!1#2!.&/%!/.!-52$%!(*!(/5!$%=!9$&2;),>!X./%0!32+4255$!$1!#/0#!-)++2%1!

52425.! $%=! C/1#()1! -(%=)-1/42! 025! (+! C$12+! $1! 1#2! -(%1$-1! ,$1-#! /%12+*$-2!

9$'!-$).2!.&/%!/++/1$1/(%>!!

• G24/-2! ,$+1.! 1#$1! $+2! /%! ,#'./-$5! -(%1$-1! C/1#! #)9$%! ?(='! $*12+! ).$02!

.#()5=!?2!&2,1!-52$%>!!

• G(! %(1! (,2+$12! =$%02+().! 2@)/,92%1! (+! =+/42! 9(1(+! 42#/-52.! =)+/%0!

1+2$192%1>!!

• "+2$192%1!/992=/$125'!,+/(+!1(!?2=1/92!9$'!-$).2!=/**/-)51'!*$55/%0!$.522,>!

• X.2!(%5'!1#2!,(C2+!.),,5'!,+(4/=2=!C/1#!1#2!32+4255$!=24/-2!1(!-#$+02!1#2!

=24/-2!$%=!1#2!#2$=.21>!

• G(!%(1!(,2+$12!1#2!=24/-2!/%!$+2$.!(*!.1+(%0!252-1+(9$0%21/-!/%12+*2+2%-2!!

• "(!$4(/=!2<,5(./(%:!=(!%(1!).2!1#/.!=24/-2!%2$+!*5$99$?52!$%2.1#21/-.!(+!/%!$!

#',2+?$+/-!(<'02%!-#$9?2+>!

• "#2! =24/-2! 2%-5(.)+2! /.! %(1! ).2+;.2+4/-2$?52>! L,2%/%0! (*! 1#2! =24/-2! C/55!

+2.)51!/%!4(/=/%0!(*!C$++$%1'>!

PAGE%7%OF%38%

B=42+.2!742%1.!

B=42+.2!242%1.!$+2!+$+2>!B=42+.2!242%1.!*+(9!,$1/2%1!=$1$!+2,(+1!$!*2C!/%.1$%-2.!

(*!=/MM/%2..:! .&/%! /++/1$1/(%:! $%=! #2$=$-#2.>! Z+(5(%02=! 1+2$192%1! $1! #/0#! -)++2%1!

52425.! 9$'!-$).2!=/MM/%2..! (+! %$).2$>! "#2.2! $=42+.2! 2**2-1.!$+2!).)$55'! 9/1/0$12=!

?'!+2=)-/%0!1#2!-)++2%1!/%12%./1'!52425>!B5C$'.!%(1/*'!'()+!#2$51#-$+2!,+$-1/1/(%2+!

/992=/$125'!/*!'()+!#2$51#!-(%=/1/(%.!=(!%(1!/9,+(42!(+!/*!'()!2<,2+/2%-2!$%'!./=2!

2**2-1.>!

PAGE%8%OF%38%

32+4255$!G2.-+/,1/(%!

32+4255$! -(%./.1.! (*! $! 9$/%! =24/-2! $%=! $! .12+2(! #2$=.21! 1#$1! /.! -(%%2-12=! 1(! 1#2!

9$/%! =24/-2! 4/$! $! -$?52>! "#2! =24/-2! /.! -(%1+(552=! C/1#! $%! $,,! /%.1$552=! (%! ).2+A.!

.9$+1! =24/-2>! 32+4255$! -(99)%/-$12.! C/1#! 1#2! .9$+1! =24/-2! 4/$! $! K5)21((1#®!

-(%%2-1/(%>!E%!$==/1/(%:!1#2!32+4255$!.12+2(!#2$=.21!/.!$5.(!K5)21((1#;2%$?52=!*(+!

.2-(%=! K5)21((1#! -(%%2-1/(%! $55(C/%0! ,$1/2%1! 1(! ).2! 1#2! $)=/(! ,(+1/(%! (*! 1#2!

#2$=.21!=)+/%0!1+2$192%1>!

"#2!-(9,(%2%1.!(*!1#2!32+4255$!=24/-2!$+2!.#(C%!?25(CS!

1. 7<12+%$5!3$+=?($+=!K(<!TZ]FS!EFG;KL^U!

2. 32+4255$!3+$%/$5!752-1+(1#2+$,'!81/9)5$1(+!T378U!TZ]FS!EFG;378U!

3. 32+4255$!BF3!#2$=.21!C/1#!/%120+$12=!1+2$192%1!252-1+(=2.!TZ]FS!EF3;\7BG87"U!

4. 8C/1-#/%0!B3]G3!Z(C2+!B=$,12+!TZ]FS!YB";_R_Q___XU!

5. X8K!3#$+0/%0!3$?52!TZ]FS!EFG;X8KU!

6. 3(%%2-1/%0!3$?52!TZ]FS!EF3;33U!

7. 3(%=)-1/42!Y25!TZ]FS!8,2-1+$!`a_!QV;_VU!!

8. Z+(12-1/42!3$.2!TZ]FS!EFG;3B87U!

9. Z+/%12=!X.2+A.!J$%)$5!T%(1!,/-1)+2=U!TZ]FS!EFG;LEJU!

PAGE%9%OF%38%

32+4255$!B,,!821;X,!

Charge%both%the%Cervella%device%and%the%stereo%headset%fully%before%first%and%each%

subsequent% use>! N/+.1:! /%.2+1! 1#2! ,(C2+! -(+=! /%1(! J/-+(;X8K! -#$+0/%0! ,(+1! (%! 1#2!

32+4255$!=24/-2!TQU!$%=!-(%%2-1!1#2!(1#2+!./=2!1(!1#2!,(C2+!$=$,12+!,+(4/=2=>![#2%!

32+4255$! -#$+02! /.! -(9,5212=! T/%=/-$12=! ?'! 1#2! 32+4255$! H7G! 1)+%/%0! 0+22%:! -#$+02!

'()+! .12+2(! #2$=.21! TVU! .(! '()! -$%! ).2! 1#2! #2$=.21! *(+! $)=/(! $%=! B-1/42! F(/.2!

3$%-255$1/(%!TBF3U!*)%-1/(%.!=)+/%0!1+2$192%1>!

7%.)+2!1#$1!'()+!.9$+1!=24/-2!T2>0>!,#(%2!(+!1$?521U!$%=!$)=/(!.()+-2!T-$%!?2!.$92!

(+!=/**2+2%1!*+(9!=24/-2!+)%%/%0!1#2!32+4255$!$,,U!/.!K5)21((1#!-$,$?52!$%=!*2$1)+2.!

K5)21((1#® 42+./(%!b>_! (+! $?(42>! 32+4255$! /.! =2./0%2=! 1(! C(+&! C/1#! .9$+1! =24/-2.!

.)-#! $.! -255,#(%2.! (+! 1$?521.! +)%%/%0! (%! B,,52! /L8! (+! Y((052! B%=+(/=! (,2+$1/%0!

.'.129.>!!

STEP% 1:!G(C%5($=! $%=! /%.1$55! 1#2! 32+4255$!

B,,! (%! '()+! .9$+1! =24/-2! ?'! 4/./1/%0!1#2!

B,,52!B,,!.1(+2!T/*!'()!(C%!$%! /L8!=24/-2U!

(+! 1#2! Y((052! Z5$'! .1(+2! T/*! '()! (C%! $%!

B%=+(/=!=24/-2U!$%=!1',/%0!c-2+4255$d!/%!1#2!

.2$+-#!?(<>!

STEP% 2:!W2+/*'!1#$1! 1#2! K5)21((1#!

*)%-1/(%$5/1'! /.! 2%$?52=! (%!'()+! .9$+1!

=24/-2!$%=!1#$1! '()+! .9$+1!=24/-2!*2$1)+2.!

K5)21((1#!b>_!(+!#/0#2+!/%!(+=2+!1(!).2!1#2!

32+4255$! =24/-2>!7%.)+2! 1#$1! '()! -$%! #$42!

E%12+%21!$--2..!*+(9!'()+!.9$+1!=24/-2>!

STEP%3!H$)%-#!1#2!32+4255$!B,,>!N(55(C!1#2!

O20/.1+$1/(%! ,+(9,1.! 1(! .21;),! $! ).2+!

$--()%1! *(+! 1#2! ,)+,(.2! (*! $)1(9$1/-$55'!

+2-(+=/%0!'()+!1+2$192%1!#/.1(+'!C#/-#!C/55!

?2!).2*)5!C#2%!'()!=/.-)..!'()+!1+2$192%1!

C/1#!'()+!#2$51#!,+(4/=2+>!

PAGE%10%OF%38%

"#2!).2+%$92!$%=!,$..C(+=!.#()5=!?2!$1!52$.1!a!-#$+$-12+.!5(%0>!F(12S!*(+!.2-)+/1'!

,)+,(.2.:!(%5'!J(%1#!$%=!D2$+!(*!1#2!+20/.12+2=!).2+!?/+1#=$'!C/55!?2!+2-(+=2=>!

"#2!32+4255$!=24/-2!/.!%(1!/%12%=2=!1(!?2!).2=!*(+!,$1/2%1.!)%=2+!Qe!

'2$+.!(5=!C/1#()1!$=)51!.),2+4/./(%>!Z$1/2%1.!)%=2+!Qe!'2$+.!(*!$02!C/55!

%22=!1(!#$42!1#2/+!,$+2%1!(+!520$5!0)$+=/$%!,2+*(+9!1#2!=24/-2!

+20/.1+$1/(%!,+(-2..>%

STEP%4:!8252-1!Z$/+/%0!*+(9!1#2!=+(,;=(C%!92%)!$%=!,+2..!c82$+-#!*(+!32+4255$d!1(!

2%12+!1#2!,$/+/%0!92%)>!F2<1:!Z+2..!c82$+-#!B0$/%>d!E*!'()+!32+4255$!/.!%2$+?'!$%=!

-#$+02=:!/1!.#()5=!$,,2$+!/%!1#2!5/.1!$.!.#(C%!?25(C>!8252-1!c32+4255$;^^^^d!$%=!1#2!

H7G!(%!1#2!32+4255$!=24/-2!.#()5=!1)+%!(%!YO77F>!Note:!the!app!always!searches!for!

closest!Cervella,!so!if!there!are!multiple!Cervella!devices!in!the!area,!the!closest!to!

your!smart!device!will!appear!on!top!of!the!list.%

PAGE%11%OF%38%

STEP%5:!E*!,5$%%/%0!1(!).2!1#2!#2$=,#(%2.:!,$/+!1#2!#2$=,#(%2.!C/1#!'()+!.9$+1!

=24/-2!$.!=2.-+/?2=!/%!1#2!Headphones!.2-1/(%!(*!1#/.!9$%)$5>!"#/.!C/55!2%$?52!'()!1(!

).2!1#2!.12+2(!#2$=.21!*(+!5/.12%/%0!1(!$)=/(!*+(9!'()+!.9$+1!=24/-2!=)+/%0!

1+2$192%1>!!

D()+!32+4255$!=24/-2!/.!%(C!+2$='!1(!).2f!

Cervella Battery Level

D()!-$%!-#2-&!1#2!52425!(*!1#2!32+4255$!/%12+%$5!

?$112+'!?'!0(/%0!/%1(!1#2!Z$/+/%0!J2%)!$.!.#(C%>!

"#2+2!$+2!%(!LF]LNN!.C/1-#2.!.(!32+4255$!0(2.!1(!

c.522,d!C#2%!'()!1)+%!(**!1#2!32+4255$!$,,!$%=!1#2!

H7G!(%!1(,!(*!32+4255$!1)+%.!(**>!O2929?2+!1(!

-#$+02!1#2!32+4255$!=24/-2!,+/(+!1(!).2:!$.!'()!

-$%%(1!).2!1#2!32+4255$!.1/9)5$1/(%!C#/52!-#$+0/%0>!!!

Bluetooth Information

E%!(+=2+!1(!2%.)+2!)%/%12++),12=!-(99)%/-$1/(%!?21C22%!1#2!32+4255$!$%=!'()+!

-(%1+(55/%0!.9$+1!=24/-2:!2%.)+2!1#$1!'()!&22,!1#2!=/.1$%-2!1(!1#2!32+4255$!=24/-2!

C/1#/%!QR*1!TR9U>!E*!1#/.!=/.1$%-2!/.!2<-22=2=:!32+4255$!9$'!1)+%!(**!$%=!1#2!1+2$192%1!

C/55!.1(,>!E%!(+=2+!1(!-(%1/%)2!1+2$192%1:!9(42!?$-&!C/1#/%!+$%02:!+2-(%%2-1!1#2!

32+4255$!)./%0!c"()-#!1(!3(%%2-1d!*)%-1/(%!/%./=2!1#2!1/92+!-/+-52!C/1#/%!1#2!$,,:!$%=!

+2;.1$+1!1#2!1+2$192%1>!!

N(+!(,1/9$5!$)=/(!@)$5/1':!2%.)+2!1#$1!1#2!$)=/(!.()+-2!/.!&2,1!C/1#/%!QR*1!TR9U!*+(9!

1#2!32+4255$!#2$=,#(%2.>!E*!1#2!=/.1$%-2!/.!2<-22=2=:!'()!9$'!#2$+!1#2!$)=/(!?+2$&;

),!(+!.1(,>!E*!1#2!$)=/(!=20+$=2.!(+!.1(,.!-(9,52125':!,52$.2!1)+%!(**!1#2!32+4255$!

$)=/(!#2$=.21:!9(42!C/1#/%!+$%02:!$%=!1)+%!(%!1#2!#2$=.21!?$-&!(%>!

PAGE%12%OF%38%

32+4255$!L,2+$1/(%!

STEP%1:%7%.)+2!1#$1!1#2!32+4255$!=24/-2!$%=!'()+!.12+2(!#2$=.21!$+2!-#$+02=!,+/(+!1(!

).2:!$.!'()!-$%%(1!).2!1#2!32+4255$!C#/52!?2/%0!-#$+02=>!J$&2!.)+2!1#$1!1#2!.&/%!

$+()%=!'()+!2$+.!/.!-52$%!(*!(/5!$%=!9$&2;),>!!O29(42!$%'!2$++/%0.:!,/2+-/%0.:!

#2$+/%0!$/=.:!(+!I2C25+'!?2*(+2!.1$+1/%0!1+2$192%1> B,,5'!$!5$'2+!(*!-(%=)-1/42!025!(+!

T/*!%(1!$4$/5$?52U!C$12+!$1!1#2!,(/%1!(*!.&/%!-(%1$-1!?2#/%=!2$-#!2$+!$+2$!T9$.1(/=U!$.!

-/+-52=!?25(C!$%=!$5.(!1(!1#2!0(5=;-(5(+2=!.&/%!9$.1(/=!-(%1$-1!,(+1/(%!(*!1#2!2$+!

-).#/(%.>!Only%apply%the%gel%only%to%the%electrode%area%that%will%be%in%contact%with%

the%mastoid%area%behind%each%ear%as%shown%below.!

Do%NOT%operate%the%device%without%gel%or%water%on%the%mastoid%area%

and%electrode%as%skin%irritation%and%uncomfortable%treatment%may%

result.!

PAGE%13%OF%38%

STEP%2:%3(%%2-1!1#2!32+4255$!=24/-2!$%=!1#2!#2$=.21!)./%0!1#2!-(%%2-1/%0!-$?52>!L%2!

2%=!(*!1#2!-$?52!-(%%2-1.!1(!1#2!32+4255$!,(+1!$%=!1#2!(1#2+!2%=!-(%%2-1.!1(!1#2!

-/+-)5$+!,(+1!)%=2+!(%2!(*!1#2!2$+!-).#/(%.>!F2<1:!,5$-2!1#2!#2$=.21!(%!,$12%1A.!#2$=!

$%=!2%.)+2!1#$1!1#2!252-1+(=2.!$+2!9$&/%0!0((=!.&/%!-(%1$-1!?'!02%15'!,+2../%0!1#2!

2$+!-).#/(%.!$0$/%.1!1#2!,$1/2%1A.!#2$=!$.!.#(C%!?25(C>!%

PAGE%14%OF%38%

Home Menu

STEP%3:%H$)%-#!1#2!32+4255$!B,,>!"#2!$,,!C/55!?2!/%!1#2!\(92!92%)!$.!.#(C%!?25(C>!

8252-1!1#2!1+2$192%1!*+2@)2%-'>!"#2!=2*$)51!$%=!9(.1!C/=25'!).2=!$%=!.1)=/2=!

*+2@)2%-'!*(+!-+$%/$5!252-1+(1#2+$,'!.1/9)5$1/(%!/.!Q__\M>!E*!1#2!=2*$)51!*+2@)2%-'!/.!

%(1!2**2-1/42:!1+'!_>R\M!(+!Q>R\M>!F2<1:!.252-1!1#2!G)+$1/(%!(*!1#2!1+2$192%1>!"#2!

(,1/9$5!$%=!=2*$)51!1+2$192%1!=)+$1/(%!/.!`_!9/%)12.>!"+2$192%1.!/%!2<-2..!(*!Q!#()+!

$+2!1',/-$55'!%(1!%2-2..$+'!$%=!1+2$192%1.!.#(+12+!1#$%!V_!9/%)12.!9$'!%(1!?2!

2**2-1/42>%

STEP% 4:!Z+2..! 1#2! -/+-)5$+!?)11(%!(%! 1#2! B,,!1(! -(%%2-1! 1(! 32+4255$>! "#2! H7G!

/%=/-$1(+! (%!1#2!32+4255$!.#()5=! 1)+%!(%!BLUE!$%=!?2! ?5/%&/%0!$%=!1#2! -()%1=(C%!

1/92+! .#()5=! .1$+1>! If% the% light% remains% solid% BLUE%and% timer% does% not% start,% the%

electrodes%are%not%making%good%electrical%contact%with%your%skin%at%the%mastoid.!

"$,! 1#2! /%12%./1'! ?$+! ),! 1(!$=I).1! 1#2! -)++2%1! /%12%./1'! )%1/5! '()! .1$+1! *225/%0! $!

1/%05/%0!.2%.$1/(%>!"#2%:!1$,!1#2! /%12%./1'!?$+! =(C%!1(!+2=)-2!1#2!/%12%./1'!.(!1#2!

1/%05/%0! .2%.$1/(%! /.! ?$+25'! ,2+-2,1/?52>! E*! 1#2! 1/%05/%0! .2%.$1/(%! /.! )%-(9*(+1$?52!

242%!$1!1#2!5(C2.1!.211/%0:!/1!).)$55'!92$%.!1#$1!1#2+2!/.!%(1!2%()0#!-(%=)-1/42!025!

?21C22%!1#2!.&/%!$%=!1#2!2$+!-).#/(%!$1!1#2!9$.1(/=!

$+2$! -(%1$-1! ,$1-#>! Note:% you% should% never% adjust%

the%treatment%level%so%that%the%tingling%sensation%is%

uncomfortable% or% painful.% It% has% been% clinically%

demonstrated% that% higher% current% levels% do% not%

result% in% better% or% faster% clinical% outcomes% so% only%

use%the%current%level%that%is%comfortable.!!!

E*! '()! %22=! 1(! ,$).2! 1#2! 1+2$192%1:! ./9,5'! +29(42!

1#2! #2$=.21>! 32+4255$! C/55! $)1(9$1/-$55'! +2.)92! 1#2!

1+2$192%1! C#2%! /1! =212-1.! 0((=! -(%1$-1! ?21C22%!

1#2!252-1+(=2.!$%=!,$1/2%1A.!.&/%>!E*!'()!%22=!1(!.1(,!

1#2!1+2$192%1:!1$,!1#2!-/+-52!$+2$!(%!1#2!$,,!$%=!1#2!

1+2$192%1!C/55!.1(,!$%=!1#2!1/92+!C/55!+2.21>!

D()! 9$'! ).2! 1#2! $)=/(!*2$1)+2! (*! '()+! .12+2(!

#2$=.21! =)+/%0! 1+2$192%1! T1)+%! (%! $%=! ,$/+! '()+!

#2$=,#(%2.!*/+.1U>! !

PAGE%15%OF%38%

32+4255$!*2$1)+2.!$!9)51/;-(5(+!H7G!.1$1).!/%=/-$1(+:!C#/-#!/%*(+9.!1#2!).2+!$?()1!

1#2!.1$1).!(*!1#2!=24/-2!$.!=2.-+/?2=!?25(CS!

When%Cervella%

is%Charging%

When%Cervella%needs%

to%be%recharged%

When%Cervella%is%

connected%to%the%

smart%device%and%app%

When%Cervella%is%

operating%

E%=/-$1(+!

-#$%02.!1(!

?5/%&/%0!O7G%

[#2%!1#2!?$112+'!52425!

=+(,.!?25(C!V_g:!1#2!

/%=/-$1(+!-#$%02.!1(!

O7G:!$%=!?5/%&.!`!

1/92.!242+'!Q_!

.2-(%=.!

E%=/-$1(+!-#$%02.!1(!

YO77F!C#2%!1#2!

=24/-2!/.!

-(%%2-12=],$/+2=!

C/1#!1#2!B,,!$%=!

.9$+1!=24/-2!

E%=/-$1(+!-#$%02.!1(!

?5/%&/%0!KHX7!(%-2!1#2!

1+2$192%1!/.!)%=2+0(/%0!

$%=!1#2!-)++2%1!/.!

*5(C/%0!

E%=/-$1(+!-(5(+!

/.!YO77F!C#2%!

32+4255$!/.!

-(9,52125'!

-#$+02=%

[#2%!1#2!?$112+'!52425!

=+(,.!?25(C!Rg:!1#2!

H7G!-(5(+!/.!$512+%$1/%0!

O7G!$%=!YO77F!$%=!

?5/%&.!

E%=/-$1(+!/.!LNN!C#2%!

1#2!B,,!/.!2</12=!$%=!

1#2!?$112+'!52425!/.!

$?(42!V_g!

E%=/-$1(+!-(5(+!/.!.(5/=!

KHX7!C#2%!1#2!=24/-2!/.!

=/.-(%%2-12=!*+(9!1#2!

#2$=.21!(+!1#2!#2$=.21!

/.!+29(42=!*+(9!

,$1/2%1A.!#2$=!$%=!1#2+2!

/.!%(!-)++2%1!*5(C!

TABLE'1:'Cervella'LED'Status'Indicator'

PAGE%16%OF%38%

Treatment History

"#2!1+2$192%1!#/.1(+'!.-+22%!

$)1(9$1/-$55'!5(0.!,$1/2%1A.!

1+2$192%1!,$+$9212+.!/%-5)=/%0!

1+2$192%1!=$12:!1/92:!1+2$192%1!

/%12%./1'!52425:!*+2@)2%-':!$%=!

=)+$1/(%>!"+2$192%1!#/.1(+'!

.-+22%!/.!).2*)5!$.!$!+2*2+2%-2!*(+!

1#2!,$1/2%1!=)+/%0!=/.-)../(%!C/1#!

#/.!(+!#2+!#2$51#!,+(4/=2+>!

User Menu

"#2!X.2+!J2%)!.#(C.!1#2!).2+A.!/%*(+9$1/(%!2%12+2=!=)+/%0!+20/.1+$1/(%!

,+(-2..>!X.2+!-$%!5(0!/%!$%=!()1!(*!1#2!$--()%1!/%!-$.2!9(+2!1#$%!(%2!).2+!

).2.!1#2!32+4255$!=24/-2>!7$-#!).2+!$--()%1!.1(+2.!).2+A.!1+2$192%1!#/.1(+'!/%!

$%!2%-+',12=!$%=!=2;/=2%1/*/2=!T$%(%'9().U!*(+9$1!(%!1#2!-5()=!.2+42+>!!

PAGE%17%OF%38%

Cervella Headphones

PAGE%18%OF%38%

Name%

Description%

Headband%

B=I).1$?52!#2$=?$%=!

Battery%Indicator%LED!

Y5(C.!RED!C#/52!-#$+0/%0!$%=!05(C.!BLUE!C#2%!1#2!

#2$=.21!/.!*)55'!-#$+02=>!

Micro%USB%Charging%

Port%

\2$=,#(%2!,(C2+.!(**!C#/52!-#$+0/%0>!

Note:%Do%not%use%headphones%while%charging.%

Volume+%/%Skip%

Forward!

Z+2..!/1!1(!/%-+2$.2!1#2!4(5)92>!Z+2..!$%=!#(5=!/1!1(!.&/,!1(!

%2<1!$)=/(!1+$-&>!

MFB%(Multi-function%

Button)%

Power%On/Off:%Z+2..!$%=!#(5=!V!.2-(%=.!1(!,(C2+!(%:!,+2..!

$%=!#(5=!`!.2-(%=.!1(!,(C2+!(**>!

TL%-2!,(C2+2=!(%:!1#2!#2$=.21!2%12+.!,$/+/%0!9(=2!

$)1(9$1/-$55'!$*12+!R!.2-(%=.U!

Phone%Call%Control:%Z+2..!1(!$%.C2+]#$%0!),>!Z+2..!$%=!

#(5=!1(!+2I2-1!-$55>!

Voice%Control:%Z+2..!1C/-2!1(!$-1/4$12!8/+/!T/*!,$/+2=!1(!$%!

B,,52!=24/-2U>!

Music%Play%Control:%Z+2..!1(!,5$'],$).2>!

Volume-/Skip%

Backward!

Z+2..!1(!1)+%!4(5)92!=(C%>!Z+2..!$%=!#(5=!1(!,5$'!,+24/().!

$)=/(!1+$-&>!

Status%Indicator%LED!

Pairing:%!"#2!H7G!?5/%&.!$512+%$1/%0!RED!$%=!BLUE!

Connected:%"#2!H7G!?5/%&.!BLUE!@)/-&5'!242+'!R!.2-(%=.!

Calling:%"#2!H7G!?5/%&.%BLUE!.5(C5'!242+'!R!.2-(%=.!

ANC%(Active%Noise%Cancellation)%Mode:%H7G!05(C.!GREEN!

C#2%!1)+%2=!(%>!

3.5mm%Cervella%

connection!

"#/.!,(+1!/.!).2=!1(!-(%%2-1!1#2!#2$=.21!1(!1#2!32+4255$!

=24/-2>!!

Note:%Do%not%use%to%connect%to%audio%source%as%damage%to%

your%audio%device%may%occur!%

Microphone!

J/-+(,#(%2!*(+!-$55/%0!C#2%!,$/+2=!1(!'()+!.9$+1,#(%2>!

10%

Active%Noise%

Cancellation!

Z+2..!1(!1)+%!(%](**!BF3!*)%-1/(%>!

PAGE%19%OF%38%

Headphone Pairing

STEP%1:!"(!,)1!'()+!#2$=,#(%2!/%!,$/+/%0!9(=2:!,+2..!$%=!#(5=!1#2!JNK!?)11(%!TRU!

*(+!V!.2-(%=.!)%1/5!1#2!#2$=.21!,(C2+.!(%!$%=!2%12+.!,$/+/%0!9(=2!$)1(9$1/-$55'!

$*12+!R!.2-(%=.>!H7G!/%=/-$1(+!ThU!C/55!*5$.#!KHX7!$%=!O7G!$512+%$125'>!F(12S!1#2!

#2$=,#(%2.!C/55!,(C2+!(**!$*12+!R!9/%)12.!/*!%(!K5)21((1#!=24/-2!/.!-(%%2-12=>!

STEP%2:!B-1/4$12!K5)21((1#!(%!'()+!.9$+1,#(%2!T(+!(1#2+!K5)21((1#;2%$?52=!$)=/(!

.()+-2U!$%=!.21!/1!1(!.2$+-#!*(+!%2C!=24/-2.>!

/Z#(%2!8211/%0.!i!K5)21((1#!i!L%!

B%=+(/=!8211/%0.!i!K5)21((1#S!L%!i!8-$%!*(+!=24/-2.!FL"7S!J2%).!9$'!4$+'!?'!=24/-2!

STEP%3:!8252-1!“Cervella-headset”!from%the%list%of%available%Bluetooth%devices.!E*!

%2-2..$+':!2%12+!*()+!M2+(.!T____U!*(+!,$..!-(=2!(+!$--2,1!-(%%2-1/(%>!L%-2!

.)--2..*)55'!,$/+2=:!1#2!#2$=,#(%2!H7G!/%=/-$1(+!*5$.#2.!BLUE>!

Note:'Avoid'connecting'additional'Bluetooth'devices'(other'than'Cervella'device'

and'headphone'connection)'to'your'smart'device'in'order'to'ensure'uninterrupted'

audio'streaming'during'treatment.''

Active Noise Cancellation (ANC)

ANC%Button:!Z+2..!1#2!BF3!?)11(%!(%!1#2!+/0#1!(*!1#2!#2$=,#(%2!1(!$-1/4$12!1#2!

%(/.2!-$%-255$1/(%!$%=!1#2!H7G!/%=/-$1(+!1)+%.!0+22%>!Z+2..!BF3!?)11(%!$0$/%!1(!1)+%!

(**!1#2!%(/.2!-$%-255$1/(%!$%=!/%=/-$1(+!1)+%.!(**>!

Charging the Headphones

Z52$.2!,5)0!J/-+(!X8K!/%1(!#2$=,#(%2!-#$+0/%0!,(+1!$%=!-(%%2-1!1#2!(1#2+!./=2!1(!

1#2! X8K! -#$+02+! ,+(4/=2=>! "#2! K$112+'! E%=/-$1(+! H7G! TVU! /%=/-$1(+! 1)+%.! O7G!C#/52!

-#$+0/%0!$%=!1)+%.!?5)2!C#2%!*)55'!-#$+02=>!F(12S!"#2!#2$=,#(%2!+29/%=.!'()!1#$1!

1#2!?$112+'!/.!5(C!242+'!QR!9/%)12.!C#2%!1#2!?$112+'!,(C2+!/.!?25(C!Q_g>!

PAGE%20%OF%38%

N+2@)2%15'!B.&2=!j)2.1/(%.!

Clinical%

Q:%How%soon%will%I%start%feeling%better?%

BS!J(.1!,$1/2%1.!.1$+1!*225/%0!1#2!,(./1/42!2**2-1.!(*!-+$%/$5!252-1+(1#2+$,'!

.1/9)5$1/(%!C/1#/%!1#2!*/+.1!C22&>!F(12!1#$1!+2.)51.!4$+'!$%=!$+2!=2,2%=2%1!(%!'()+!

-(%=/1/(%>!B5C$'.!-(%.)51!'()+!#2$51#-$+2!,+(4/=2+!?2*(+2!.1$+1/%0!32+4255$!$%=!

*(55(C!1#2!1+2$192%1!,5$%!$.!=/+2-12=>!B%</21'!/.!(*12%!+2=)-2=!$*12+!$!./%052!

1+2$192%1!?)1!9$'!+2(--)+!.(!-(%./.12%1!1+2$192%1!.2../(%.!$+2!+2-(992%=2=>!

J$%'!,$1/2%1.!.)**2+/%0!*+(9!$%</21'!*/%=!/1!).2*)5!1(!).2!32+4255$!$1!1#2!(%.21!(*!

$%</21'!(+!?2*(+2!$!#/0#!.1+2..!./1)$1/(%>!Z$1/2%1.!C/1#!=2,+2../(%!C/55!(*12%!.22!

/9,+(4292%1.!/%!$!*2C!C22&.:!?)1!,$1/2%1.!.#()5=!-(%1/%)2!1(!).2!32+4255$!$.!

=/+2-12=!?'!1#2/+!#2$51#-$+2!,+(4/=2+>!E%.(9%/$!/.!(*12%!+2=)-2=!$*12+!$!./%052!

1+2$192%1!?)1:!5/&2!=2,+2../(%:!-(%./.12%1!1+2$192%1!.2../(%.!$+2!+2-(992%=2=!

242%!C#2%!'()!$+2!*225/%0!?2112+>![#2%!-(%=/1/(%.!/9,+(42:!,52$.2!).2!32+4255$!$1!

+2=)-2=!/%12+4$5.!(+!(%!$%!$.;%22=!?$./.!$.!/%.1+)-12=!?'!'()+!#2$51#-$+2!,+(4/=2+>!

Q:%What%should%be%the%optimal%treatment%intensity%level?%

BS!"#2!(,1/9$5!1+2$192%1!/%12%./1'!52425!/.!C#2%!'()!*225!$!.5/0#1!1/%05/%0!$+()%=!

'()+!2$+.:!?)1!1#2!.2%.$1/(%!/.!%242+!)%-(9*(+1$?52!(+!,$/%*)5>!E1!#$.!?22%!-5/%/-$55'!

=29(%.1+$12=!1#$1!#/0#2+!-)++2%1!52425.!=(!%(1!+2.)51!/%!?2112+!(+!*$.12+!-5/%/-$5!

()1-(92.!.(!(%5'!).2!1#2!-)++2%1!52425!1#$1!/.!-(9*(+1$?52>!

Q:%What%should%I%do%if%I%experience%headache,%dizziness,%nausea,%or%other%adverse%

effects?%

BS!N/+.1:!+2=)-2!1#2!/%12%./1'!52425!=)+/%0!1+2$192%1>!"+2$192%1!.2../(%.!$1!-)++2%1!

/%12%./1'!52425.!#/0#2+!1#$%!%2-2..$+'!9$'!-$).2!=/MM/%2..!$%=!%$).2$!1#$1!-$%!5$.1!

.242+$5!#()+.!1(!$!*2C!=$'.>!E*!'()!-(%1/%)2!2<,2+/2%-/%0!$=42+.2!2**2-1.!(+!/*!'()!

2<,2+/2%-2!,$+$=(</-$5!+2$-1/(%.!.)-#!$.!/%-+2$.2=!$%</21'!(+!-(%1/%)2=!/%.(9%/$:!

-(%.)51!'()+!#2$51#-$+2!,+(4/=2+!/992=/$125'>!

Q:%Which%is%the%best%frequency%to%use?%

BS!"#2!=2*$)51!$%=!9(.1!C/=25'!).2=!$%=!.1)=/2=!*+2@)2%-'!*(+!-+$%/$5!

252-1+(1#2+$,'!.1/9)5$1/(%!/.!Q__\M>!E*!1#2!=2*$)51!*+2@)2%-'!/.!%(1!2**2-1/42:!1+'!

_>R\M!(+!Q>R\M>!!

Page is loading ...

Innovative Neurological Devices Cervella User manual

Other documents