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Table of Contents
Chapter 1: Important Information...................... 1
Indications for Use ............................................. 1When the Device Should Not be Used(Contraindications) ............................................ 2General Warnings and recautions ................... !
Warnings ........................................................ !General recautions ....................................... "
#lectro$agnetic Interference (#%I) ................ &recautions 'egarding ther %edicalrocedures ..................................................... ossible Interference *ith ther #lectronicDevices ......................................................... 1+
,our atient Identification Card ....................... 1!I$-ortance of ollo*ing a Care 'egi$en........ 1/
When to Call ,our Doctor ............................. 1"'ecovering ro$ Surger0 or n0 dverse#vents........................................................... 1&
'iss and 3enefits ........................................... 1&'iss of the rgus II S0ste$......................... 1&3enefits and 4i$itations of the rgus II S0ste$..................................................................... 21
Chapter 2: Device Description......................... 23
rgus II 'etinal rosthesis (I$-lant) ............... 2"#5ternal #6ui-$ent ......................................... 27
8ideo rocessing Unit (8U)........................ 27Glasses......................................................... !/ rgus II S0ste$ Wireless Infor$ation ...........
! rgus II atient Catalog................................... /+
Chapter 3: Preparing for Your Device ............. 43
I$-lantation Surger0........................................ /!ost9I$-lant Care............................................ /"
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Clinical ollo*9U-......................................... /"Device itting and rogra$$ing .................. /&
8isual 'ehabilitation ..................................... /7Chapter 4: sing Your Device ......................... 4!
Setu- Instructions............................................ /:-erating Instructions ..................................... "!
4#D Indicators and udible lar$s .............. "&3atter0 4ife ................................................... ":'echarging the 3atteries .............................. &+
Checing the unction of the Device............... &+Cleaning .......................................................... &+%aintenance.................................................... &1;andling and Storage...................................... &2#5-ected ailure <i$e and %ode and Its #ffecton ,ou ............................................................. &"Instructions on ;o* to Safel0 Dis-ose of the
Device ............................................................. &&8U and Glasses ......................................... &7'echargeable 3atteries and 3atter0 Charger ..................................................................... &7
rgus II I$-lant ............................................ &Dis-osal of acaging %aterial .................... &
Chapter ": Troubleshooting ............................ #!
Chapter #: $%%itional information .................. &3
Warrant0.......................................................... !S0$bols and 'egulator0 Classifications .........
Chapter ': ser $ssistance............................. !3
Write 0our i$-ortant tele-hone nu$bers here :/
Chapter &: (lossar) ......................................... !"
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Chapter 1: Important Information
In%ications for se
<he rgus II 'etinal rosthesis S0ste$ isintended to -rovide electrical sti$ulation of theretina to induce visual -erce-tion in blind -atients.It is indicated for use in -atients *ith severe to
-rofound retinitis -ig$entosa *ho $eet thefollo*ing criteria=
> re an adult? age 2" 0ears or older.
> ;ave bare light or no light -erce-tion in
both e0es. (If 0ou do not have an0
re$aining light -erce-tion? 0ou *ill betested to $ae sure that 0our e0e *ill
res-ond to electrical sti$ulation.)
> Were able to see ob@ects? sha-es and lines
in the -ast.
> ;ave no lens or an artificial lens in the e0e
that *ill be i$-lanted (If 0ou have a natural
lens in the e0e that *ill be i$-lanted? it *ill
be re$oved during the i$-lant surger0.)
> re *illing and able to receive the
reco$$ended -ost9i$-lant clinical follo*9
u-? device fitting and visual rehabilitation.
<he rgus II i$-lant *ill be i$-lanted in onl0 onee0e? $ost liel0 the e0e that has the *orse vision.
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*hen the Device +houl% ,ot be se%
-Contrain%ications
,ou should not have the rgus II 'etinal
rosthesis i$-lanted if 0ou=
> ;ave an e0e disease or condition that could
-revent the rgus II S0ste$ fro$ *oring
-ro-erl0 (for e5a$-le? o-tic nerve disease?
central retinal arter0 or vein occlusion?
histor0 of retinal detach$ent? trau$a? or
severe strabis$us).
> ;ave an e0e structure or condition (for
e5a$-le? a ver0 long or ver0 short e0e? as
$easured fro$ the front to the bac of thee0e) that could $ae it difficult to
successfull0 i$-lant the rgus II I$-lant or
recover follo*ing surger0.
> ;ave e0e diseases or conditions (other
than cataracts) *hich $ae it difficult for
0our doctor to see inside 0our e0e (for e5a$-le? a cloud0 cornea? etc.).
> re unable to undergo general anesthesia
or tae the reco$$ended antibiotic and
steroid $edications 0ou *ill need to tae
before and after surger0.
> ;ave a $etallic or active i$-lantable device
(for e5a$-le? a cochlear i$-lant) in 0our
head.
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> ;ave an0 diseaseor condition (for
e5a$-le? significant $ental decline) that
-revents 0ou fro$ understanding or giving0our infor$ed consent? fro$ undergoing the
-rogra$$ing the device after it is
i$-lanted? or fro$ having $edical follo*9
u-. ,our doctor $a0 as 0ou to have a
-s0chological evaluation to $ae sure 0ou
are 6ualified for this device.> <end to rub 0our e0e a lot.
(eneral *arnings an% Precautions
*arnings
> If 0ou have an rgus II I$-lant? do notundergo short /ave
or
micro/ave
%iatherm). <hese -rocedures could cause
high electrical current in the i$-lant
electrodes that could cause tissue da$age
or serious in@ur0. Diather$0 $a0 also cause
-er$anent da$age to the i$-lant.> If 0ou have an rgus II I$-lant? do not
undergo electroconvulsive therap) -0CT
as #C< $a0 da$age 0our e0e or 0our
rgus II i$-lant.
> If 0ou have an rgus II I$-lant and need to
undergo lithotrips) or high outputultrasoun% infor$ 0our doctor that 0ou
have this i$-lant. If 0ou have an rgus II
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I$-lant? these treat$ents $a0 har$ 0ou or
da$age the i$-lant. ,our doctor should
contact Second Sight %edical roducts for instructions in ho* to -erfor$ these
-rocedures in so$eone *ho has an rgus
II I$-lant.
> <he rgus II I$-lant has been classified as
an Con%itional device. If 0ou have an
rgus II I$-lant? 0ou $a0 undergo a$agnetic resonance i$aging (%'I)
-rocedure N4, if it is -erfor$ed using a
1." or !.+ <esla %'I S0ste$ and N4,
follo*ing s-ecial instruction. 3efore having
an %'I -rocedure? tell 0our doctor that 0ou
have the rgus II I$-lant. ,our doctor should contact Second Sight %edical
roducts for instructions in ho* to -erfor$
an %'I in so$eone *ho has an rgus II
I$-lant.
> If 0ou have an rgus II I$-lant? 0ou should
not enter a roo$ housing an I S0ste$that is not 1." or !.+ <esla? even if the
rgus II S0ste$ is not being used.
> <he rgus II S0ste$ $a0 cause me%ical
monitoring %iagnostic or life support
euipment to function i$-ro-erl0. Do not
use the rgus II S0ste$ *ithin ! feet of thist0-e of e6ui-$ent. If so$eone notices that
interference is occurring? turn off the
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rgus II 8U or e5tend the distance
bet*een 0ourself and the e6ui-$ent.
> If 0ou have an rgus II I$-lant do not
receive treat$ent *ith monopolar
electrosurgical euipment. %ono-olar
electrosurgical e6ui-$ent $a0 da$age the
i$-lant or the tissue around the i$-lant.
(eneral Precautions
> If 0ou e5-erience an0 uncomfortable
feeling *hile using the rgus II S0ste$ (for
e5a$-le? -ain)? i$$ediatel0 sto- using the
s0ste$ b0 re$oving the rgus II Glasses or
b0 turning off the rgus II 8U.
> <he long9ter$ effects of electrical
stimulation are unno*n. It $a0 cause
da$age to the retina or o-tic nerve. <his
sort of da$age could lead to a decline in
0our nor$al re$aining vision andAor ho*
*ell 0ou see *ith the rgus II S0ste$. It
could also -revent 0ou fro$ getting a
re-lace$ent rgus II I$-lant or another
t0-e of retinal i$-lant in the future.
> nl0 use a 5P that has been
specificall) programme% for )ou b0 0our
clinician. Using so$eone elseBs 8U $a0
li$it ho* *ell 0ou see *ith the rgus II
S0ste$ and $a0 cause 0ou -h0sical
disco$fort fro$ oversti$ulation.
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> void ph)sical impact or e6treme %irect
pressure to the e)e as this $a0 result in
in@ur0 to the e0e? $ove$ent or da$age tothe rgus II I$-lant. If either of these
occurs? contact 0our -h0sician.
> void rubbing the e)e that has the i$-lant
as this $a0 dislodge the i$-lant or cause
e0e irritation.
> #ven though 0ou have the rgus II I$-lant?
continue to use )our other mobilit) ai%s
(for e5a$-le? canes? dogs? etc.) at all ti$es.
> Use of the rgus II S0ste$ during
pregnanc) an% nursing has not been
evaluated.
0lectromagnetic I nterference -0I
#lectro$agnetic interference is a field of energ0
(electrical? $agnetic? or both) created b0
e6ui-$ent found in -ublic environ$ents that $a0
be strong enough to interfere *ith the nor$alo-eration of 0our rgus II S0ste$.
<he rgus II S0ste$ $eets international standards
for electro$agnetic co$-atibilit0 ('efer to
S0$bols and 'egulator0 Classifications on -age
for $ore infor$ation). <he rgus II S0ste$ is
designed to continue to o-erate in a safe $ode
in the -resence of an0 electro$agnetic
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interference that 0ou *ould encounter during 0our
nor$al ever0 da0 activit0.
It is i$-ortant to note? ho*ever? that in certain
circu$stances? electro$agnetic interference could
cause=
Serious in@ur0. #5-osure of 0our i$-lant to
#%I $a0 result in 0our i$-lant heating and
da$aging nearb0 retinal tissue. See
Warnings on -age !.
Da$age to 0our rgus II i$-lant. Da$age
to the i$-lant $a0 re6uire re-lace$entE or
result in loss of? or irreversible change in
the -erfor$ance of the rgus II S0ste$.See Warnings on -age !.
Une5-ected <urning off of the rgus II
8U. #%I $a0 cause 0our 8U to turn off
une5-ectedl0.
Interru-tion of Sti$ulation. #%I $a0 causea $o$entar0 interru-tion of sti$ulation.
If 0ou enter an environ$ent *hich $a0be
causing interference *ith 0our rgus II
S0ste$? 0ou should do the follo*ing=
1. %ove a*a0 fro$ the e6ui-$ent or ob@ect
thought to be causing the interference.
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2. If -ossible? turn off the e6ui-$ent or ob@ect
causing the interference.
!. <ell the e6ui-$ent o-erator? or 0our doctor
*hat ha--ened.
If 0ou continue to e5-erience interference? or if
0ou thin that 0our rgus II S0ste$ is not
*oring as *ell as it did before 0ou
encountered the interference? -lease contact0our doctor.
'efer to the Precautions Regarding Other Medical Procedures? the Possible Interferencewith Other Electronic Devices? or the Travel or International Use sections of this $anual for
additional infor$ation regarding -otentialsources of electro$agnetic interference andho* to use 0our rgus II S0ste$ in theseenviron$ents.
Pre c autions e g ar%ing 7 t her e%ical
Proce%ure s
If 0ou need to undergo an0 of the -rocedures
listed belo*? -lease infor$ 0our doctor that 0ou
have a retinal -rosthesis in 0our e0e. ,our doctor
should contact Second Sight at 1919!!9"+&+
for $ore infor$ation.
'e$ove the rgus II Glasses and 8U before
having an0 $edical or test -rocedure that involves
the use of other $edical e6ui-$ent. nce the
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-rocedure is co$-lete? 0ou should have 0our
rgus II I$-lant tested b0 0our clinician as soon
as -ossible to $ae sure it is still functioning-ro-erl0.
> <he use of laser phacoemulsification
fragmatome $a0 da$age the rgus II
I$-lant.
> <he use of bipolar electrosurgicaleuipment
$a0 da$age the rgus II
I$-lant.
> ,ou $a0 undergo CT +cans or Diagnostic
ltrasoun%. ;o*ever? if a scan or
ultrasound is -erfor$ed in the area *here
the rgus II I$-lant is located? the i$-lant$a0 bloc or blur the i$age $aing the
scan unreadable in this area.
> Use of
%efibrillators
or therapeutic
ioni8ing ra%iation to the head $a0
-er$anentl0 da$age the rgus II I$-lant.
;o*ever? this should not sto- 0ou fro$receiving these treat$ents? if necessar0.
<he rgus II I$-lant should be tested as
soon as -ossible follo*ing these
-rocedures to deter$ine *hether the
i$-lant is still functioning -ro-erl0. Da$age
to the i$-lant $a0 not be i$$ediatel0detectable.
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> <he effects of cobalt treatment or linear
acceleration techniues on the i$-lant
are unno*n.
Po s sible Interfere n ce / ith 7 t her 0lectronic
Devices
> Theft or metal %etectors (such as those
located in entrances to -ublic buildings and
de-art$ent stores) and airport or securit)
screening %evices $a0 interfere *ith the
rgus II S0ste$ causing interru-tion of
sti$ulation. When -ossible? it is best to
avoid these devices or turn the 8U off
*hen -assing through these s0ste$s. ,ou
should sho* 0our -atient identification cardto an0 attendant in the area *ho $a0 be
able to assist 0ou in b0-assing these
devices. If unavoidable? *al through the
scanner and -ro$-tl0 $ove a*a0 fro$ the
area. Do not lean on these scanners or
linger in their -ath.> +tatic electricit) $a0 interfere *ith nor$al
o-eration or cause da$age to the rgus II
S0ste$. Co$$on situations that create
static electricit0 include -utting on or
re$oving clothes? or dragging feet across a
car-et or rug *hen there is ver0 lo*hu$idit0 (for e5a$-le? hu$idit0 belo*
!+F). Static electricit0 can be re$oved b0
touching a $etal ob@ect. void handling the
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8U and glasses if 0ou thin there is a lot
of static electricit0 -resent.
> <he rgus II S0ste$ $a0 interfere *ith the
nor$al o-eration of so$e $odels of
hearing ai%s. If 0ou *ear a hearing aid?
0ou should have it tested *ith the rgus II
S0ste$ before 0ou are i$-lanted? to $ae
sure both the hearing aid and rgus II
S0ste$ *ill function -ro-erl0.
> So$e home appliances (for e5a$-le?
$icro*aves and co$-uter $onitors) and
so$e %evices /ith antennae (for e5a$-le?
*alie9talies? a$ateur radios? cell -hones?
and % s0ste$s) $a0 te$-oraril0 interru-t
rgus II sti$ulation if the rgus II S0ste$ islocated *ithin 1 ! 0ards of the$. Devices
*ith antennae $a0 be $ared *ith the
follo*ing s0$bol=
Nor$al o-eration *ill resu$e *hen 0ou
$ove a*a0 fro$ these ite$s.
> When the rgus II s0ste$ is used in ver0close -ro5i$it0 to marine ra%ios? nor$alo-eration of the s0ste$ $a0 be te$-oraril0interru-ted. Nor$al o-eration *ill resu$e*hen 0ou $ove a*a0 fro$ these ite$s.
> <he rgus II S0ste$ o-erates using
*ireless technolog0 *hich could interfere
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*ith the safe o-eration of an airplane. Do
not turn on the rgus II S0ste$ on an
air-lane.
> Commercial electrical euipment (such
as arc *elders? induction furnaces or
resistance *elders)?
communication
euipment (such as $icro*ave
trans$itters? linear -o*er a$-lifiers and
high9-o*er a$ateur trans$itters)?
highvoltage lines po/er lines or generators
electric steel furnaces
or large
magneti8e% spea9ers $a0 te$-oraril0
interru-t rgus II S0ste$ function. Nor$al
o-eration should resu$e *hen 0ou $ove
a*a0 fro$ these ob@ects.
<ravel or I nternational Use
,ou $a0 *ant to travel *ith 0our rgus II S0ste$.
When travelling and not using the s0ste$? it isreco$$ended that 0ou store the e5ternal s0ste$
in the travel case.
If 0ou *ill be traveling outside the United States?
0ou $a0 need an ada-ter to -lug the batter0
charger into the electrical outlet.
3ring 0our -atient identification card *ith 0ou to
assist in going through securit0 s0ste$s (this card
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current infor$ation and indicate the changes. ,ou
$a0 either call 1919!!9"+&+ *ith the
infor$ation or send it to=
Second Sight %edical roducts? Inc.
Device 'egistration
127// San ernando 'd.? 3ldg. !
S0l$ar? C :1!/2? US
In addition to 0our atient Identification Card? 0ou
$a0 *ant to *ear a %edical lert 3racelet. If 0ou
choose to -urchase one of these bracelets? it is
reco$$ended that 0ou include the follo*ing
infor$ation on it=
ctive I$-lantable Device on (right or left) #0e
See atient ID Card in $0 *allet.
SurgeonBs hone is () 9
Importance of ollo/ing a Care
egimen
<he follo*ing guidelines about 0our rgus II
S0ste$ *ill hel- to ensure that 0ou receive the
safest and $ost beneficial treat$ent.
l*a0s tell an0 $edical -ersonnel that 0ou have
an i$-lant in 0our e0e and tell the$ *here it islocated. If the0 have an0 6uestions? the0 should
contact 0our doctor or Second Sight at 1919!!9
"+&+.
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If 0ou e5-erience an0 unusual s0$-to$s that 0ou
thin $a0 be related to 0our rgus II I$-lant?
contact 0our doctor.
If 0ou have a fa$il0 $e$ber or caregiver? as
the$ to read this $anual along *ith 0ou. <here
$a0 be situations *here 0ou *ill need their
assistance.
Go to all follo*9u- a--oint$ents. <his *ill ensurethat 0ou get the best care.
*hen to Call Your Doctor
Call 0our doctor if an0 of the follo*ing situations
occur=
> ,ou are e5-eriencing an0 -ain or
disco$fort in 0our i$-lanted e0e.
> ,ou feel an0 disco$fort during sti$ulation.
irst? turn off 0our rgus II S0ste$ (b0
shutting off the 8U or taing off 0our
glasses)? then call 0our doctor.
> ,ou are having an0 difficult0 o-erating 0our
rgus II S0ste$ or an0 of the co$-onents
brea.
> ,ou feel lie the infor$ationAsti$ulation 0ou
receive fro$ 0our s0ste$ is getting *orse.
> ,ou e5-erience an0 unusual s0$-to$s that
0ou thin $a0 be caused b0
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electro$agnetic interference (such as theft
detectors).
e co v eri n g rom +ur g e r ) or $n) $% v erse
0vents
fter 0our surger0? 0our doctor or nurse *ill
-rovide 0ou *ith instructions on ho* to recover.
<hese instructions often include infor$ation about
the healing -rocess? $edications to tae? and
*hen to return for follo*9u- visits. l*a0s follo*
these instructions.
If 0ou e5-erience an0 $edical co$-lications *ith
0our i$-lant? it is i$-ortant to follo* the
instructions -rovided b0 0our doctor for ho* totreat these co$-lications.
It $a0 tae several *ees to recover fro$ surger0.
During this ti$e? 0ou $a0 feel disco$fort around
0our e0e. If 0ou notice unusual s0$-to$s? contact
0our doctor.
is9s an% ;enefits
is9s of t he $rgus I I +)stem
'iss associated *ith the rgus II S0ste$ include
surgical riss? -ossible side effects? and -otential
device co$-lications. <hese are described belo*.
'iss of Surger0
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<he riss of i$-lanting the rgus II I$-lant are
si$ilar to the riss of other e0e surgeries and
general anesthesia. <hese riss $a0 include=
> Chest -ain or heart attac
> llergic reaction to the anesthesia or to the
i$-lant $aterials
> 3lood clots in the legs or lungs (-ul$onar0
e$bolis$ or dee- vein thro$bosis)
> 'es-irator0 failure
> 3lood loss re6uiring transfusion
> Infection
> ;os-italiJation
> Urinar0 retention
> 3leeding in the e0e
> tear? hole or other da$age to the retina
> Da$age to the e0e $uscles or e0e lids
ossible Side #ff ects
Side effects of the surger0? the -resence of the
rgus II I$-lant in the e0e? or the use of the rgus
II S0ste$ $a0 include=
> <hinning of the tissue that covers thei$-lant
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> -ening of one or $ore of the of the
surgical *ounds
> decrease or increase in the internal
-ressure in 0our e0e
> Detach$ent or tear of the retina or the
choroid (a thin la0er of cells behind the
retina)
> Clouding or thinning of the cornea> 3lood vessels? de-osits or $ucus
develo-ing on the cornea
> or$ation of blood vessels on the iris
> Corneal dr0ness
> 'edness and irritation in or around the e0e(infla$$ation)
> Irritation caused b0 the sutures
> ain in or around the e0e
> ;eadaches
> or$ation of scar tissue in the e0e
> Dr0 e0e or *atering e0e
> C0sts on the e0e
> S*elling of the retina or choroid
> Decrease in re$aining light -erce-tion> oreign bod0 sensation
> Nausea or vertigo
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> ,our bod0 $a0 have an allergic reaction to
the $aterials in the i$-lant or in the
glasses? both of *hich co$e into contact*ith 0our bod0. (<he follo*ing $aterials in
the i$-lant and glasses co$e into contact
*ith 0our bod0= niobiu$? titaniu$? silicone?
-latinu$ and -lastic. While these $aterials
are co$$onl0 used to $ae $edical
i$-lants and have -assed testing to sho*that the0 should not cause a reaction? it is
still -ossible that 0ou $a0 have a reaction
to the$.)
> <here is a -ossibilit0 of da$age to 0our
retina due to trau$a? too $uch sti$ulation?
or heating of the i$-lant.
> <he i$-lant could cause facial nerve
sti$ulation? electric shoc? or sin burn due
to too $uch heating of the e5ternal
e6ui-$ent.
> <he s0ste$ could cause 0ou to fall or bu$-
into so$ething.
ossible Cascade of Co$-lic ati ons
<here is the -ossibilit0 that one co$-lication couldlead to other co$-lications. In addition? aco$-lication could lead to the *orsening of other
co$-lications. So$eti$es? it $a0 tae severalvisits to 0our doctor? several treat$ents? andAor -ossibl0 surger0 to treat a cascade of co$-lications. If the co$-lication(s) cannot be
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ade6uatel0 treated? 0ou $a0 ulti$atel0 need tohave the rgus II i$-lant re$oved fro$ 0our e0e
or -ossibl0 in the e5tre$e case have 0our e0e?itself? re$oved.
;enefit s an% <imi tations of t he $rgus II +)stem
<he rgus II S0ste$ -rovides an artificial for$ of visionE it *ill not restore nor$al vision. <he s0ste$*ill not slo* or reverse the -rogression of 0our disease. In addition? the s0ste$ *ill not re-lace0our nor$al visual aids (such as a cane). When0ou are not using the rgus II S0ste$? 0our vision*ill return to its original i$-aired state.
4earning to inter-ret the infor$ation fro$ thedevice and incor-orate it into 0our functional life
$a0 be a challenging -rocess. ,ou *ill have tolearn ho* to co$bine the infor$ation -rovided b0the rgus II S0ste$ *ith 0our e5isting assistivedevices (such as a dog or cane) and *ith thetechni6ues 0ou alread0 use to co-e *ith 0our visual i$-air$ent.
When 0ou use the rgus II S0ste$? it *ill deliver electrical sti$ulation to 0our retina that *ill allo*0ou to see -hos-henes (s-ots of light). <hea--arent siJe of the electrode arra0 in visuals-ace $a0 be about !." inches b0 &." inches? or slightl0 larger than a standard ! 5 " inde5 cardheld at ar$Bs length. ;o*ever? the actual siJe of
light 0ou see *hen all the electrodes are turned ontogether $a0 be larger or s$aller than this due toindividual variation. t first? 0ou $a0 not be able totell e5actl0 *hat 0ou are looing at. ,ou *ill need
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training to learn ho* to inter-ret the vision-rovided b0 the rgus II S0ste$.
<he rgus II S0ste$ $a0 hel- 0ou -erfor$ tassvisuall0? rather than b0 touch. or e5a$-le? duringthe clinical trial so$e sub@ects *ere able to usethe rgus II S0ste$ to locate lights and *indo*s?follo* lines on the ground (for e5a$-le in a cross*al)? avoid obstacles as the0 *aled? sortlaundr0? deter$ine *here other -eo-le *erelocated? and recogniJe large font letters and*ords. In addition? $an0 sub@ects re-orteden@o0ing seeing light after being blind for $an00ears and having a greater feeling of connection toother -eo-le.
'esults varied a$ong clinical trial sub@ects. While
the $a@orit0 of sub@ects received a benefit fro$ the rgus II S0ste$ on $ulti-le tests and e5a$s?so$e sub@ects re-orted receiving no benefit.
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Chapter 2: Device Description
<he rgus II 'etinal rosthesis S0ste$ consists of
the follo*ing $ain co$-onents and accessories=
> rgus II 'etinal rosthesis (I$-lant)
> rgus II 8ideo rocessing Unit (8U)
> rgus II Glasses (Glasses)
> ccessories=
> 8U 'echargeable 3atter0
> 8U 3atter0 Charger
> 8U ouch
> <ravel Case
*$,I,( Do not use an) euipment /ith
)our $rgus II +)stem other than
that supplie% b) +econ% +ight.
The use of cables or batteries
other than those supplie% b)
+econ% +ight ma) result in )our $rgus II s)stem being more
effecte% b) electromagnetic
interference from other %evices.
se of non=approve% cables or
batteries ma) also result in the
$rgus II +)stem interfering /ith
the performance of other
electronic euipment.
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efer to the section on
0lectromagnetic Interference
-0I for more information.
<he rgus II 'etinal rosthesis is i$-lanted in and
around 0our e0eball. <o turn on and use the
i$-lant? 0ou *ill need to *ear the glasses and
8U (*hich together are referred to as the
e5ternal e6ui-$ent.)
<he s0ste$ *ors as follo*s. $iniature video
ca$era on the glasses ca-tures a scene. <he
video is sent to the 8U *here it is -rocessed and
converted into instructions that are sent bac to
the glasses via a cable. <hese instructions are
sent *irelessl0 to a receiver in the i$-lant. <hesignals are then sent to the electrode arra0? *hich
e$its s$all -ulses of electricit0. <hese -ulses
sti$ulate 0our retinaBs re$aining cells? *hich send
the signals along the o-tic nerve to 0our brain?
resulting in the -erce-tion of light. ver ti$e? 0ou
$a0 learn ho* to inter-ret these visual -atterns asrecogniJable ob@ects.
Note= <he i$-lant is -o*ered onl0 *hen 0ou are
*earing the glasses and have the 8U turned onE
other*ise? the i$-lant is off.
#ach of these individual co$-onents is describedbelo*.
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$rgus II etinal Prosthesis -Implant
<he i$-lant consists of four -arts= (1) theelectronics case (2) the i$-lant coil? (!) electrode
arra0? and (/) the scleral band. <he i$-lant is
$ade of $etal? -lastic and silicone.
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igure 1 sho*s the i$-lant as it loos once
i$-lanted around and inside the e0e. art of the
i$-lant sits on the outside of 0our e0e (butunderneath a thin la0er of tissue that covers the
*hite -art of the e0e) and is held in -lace *ith the
scleral band that *ra-s around 0our e0e. <he
electrode arra0? *hich sti$ulates 0our retina? has
&+ electrodes arranged in a rectangular grid? "" of
*hich are turned on at the ti$e of i$-lant. U- to "of the re$aining electrodes $a0 be functional and
could be turned on to re-lace an electrode if it fails
-ost9i$-lant.
<he i$-lant has a cable that is attached to the
electronics case and is then fed through an
incision in 0our e0e. <he -ortion of the arra0 *ith
the electrodes is attached onto 0our retina *ith a
retinal tac. <he i$-lant is not visible to other
-eo-le.
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igure 1: Implant on a ight 0)e
-loo9ing at )our e)eball
#lectronics Case(outside the e0e)
I$-lant Coil(outside the e0e)
Scleral 3and(outside the e0e)
#lectrode rra0(inside the e0e)
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06ternal 0uipment
-hoto of the 8U? glasses? and batter0 is-rovided in igure 2. descri-tion of each of these co$-onents follo*s.
igure 2: 06ternal 0uipment
8U
Glasses
Glasses CoilCa$era
5i%eo Processing nit -5P
<he 8U allo*s 0ou to turn sti$ulation on and off and select the sti$ulation settings best suited to
0our current environ$ent. It is $ade of $etal and
has rubber buttons. <he 8U is connected to the
glasses using a cable? and both $ust be *orn in
order to -o*er the i$-lant. When the 8U is on
and 0ou are *earing the glasses? the 8U is in
constant co$$unication *ith the i$-lant. <he
8U also tracs *hen it is s*itched on and off?
ho* *ell 0our i$-lant and 8U function? and
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*hether the co$$unication bet*een the i$-lant
and 8U is interru-ted. ,our clinician can $onitor
this infor$ation *hen 0ou visit the clinic.
<he 8U buttons are large and sha-ed so that
the0 can be easil0 identified b0 touch. <he glasses
rece-tacle connects the 8U to the glasses. <he
co$$unication ada-ter connector connects the
8U to a co$-uter *hich is onl0 used during
testing in the clinic. When not in use? the
co$$unication ada-ter connector on the 8U is
covered b0 a $etal door. <he 8U *ith the batter0
*eighs about half a -ound? see igure ! for a
diagra$ of the 8U.
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Component Description
Inverse
Setting
3utton
<he s6uare9sha-ed button
located on the right9hand side
of the 8U is used to invert the
i$age fro$ blac9to9*hite and
*hite9to9blac. #ach ti$e the
button is -ressed? the i$age is
inverted. It is set to the non9
invert $ode ever0 ti$e the8U is s*itched on.
udible '
4in lar$
3utton
<he star9sha-ed button located
on the botto$ of the right side
of the 8U is used to enable or
disable the audible alar$ that
indicates if the co$$unicationlin *ith the i$-lant has been
interru-ted. <he default setting
is ' lin alar$ on. It is set to
the ' lin alar$ on $ode
ever0 ti$e the 8U is s*itched
on.
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Component Description
3atter0
'ece-tacle
<he batter0 rece-tacle? located
on the botto$ third of the front
-anel? is *here the
rechargeable batter0 is
installed on the 8U. <he
rece-tacle has a e0ing
$echanis$ that -revents
incorrect installation of thebatter0.
3atter0
4atch
<he batter0 latch? located on
the left side of the 8U? is a
t*o9-osition? sliding latch that
auto$aticall0 slides into the
loced -osition *hen abatter0 is -ro-erl0 inserted into
the rece-tacle. <o re$ove a
batter0? 0ou $ust first slide the
latch to its un9loced -osition.
'efer to Cha-ter / for details
about inserting and re$ovingthe batter0.
4#D
Indicators
<hree indicator lights are
located on the front of the 8U
in bet*een the oval control
buttons. <hese give a visual
indication of the o-eratingstatus of the 8U.
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Component Description
Glasses
'ece-tacle
<he glasses rece-tacle is a
round connector on the to- of
the 8U that acce-ts the
glasses cable -lug. 'efer to
Cha-ter /? Connecting the
glasses to the 8U for $ore
infor$ation.
Co$$uni9
cation
da-ter
(C)
Connector
4ocated on the botto$ of the
8U? this rectangular9sha-ed
connector acce-ts the cable
co$ing fro$ the
co$$unication ada-ter. Used
onl0 in the clinic? it is -rotected
b0 a $etal door *hen not inuse.
Table 2: 5P $ccessories
$ccessor) Description
3atter0 S$all and $ediu$ siJedrechargeable batteries are
available for use *ith the 8U.
nl0 use rechargeable
batteries -rovided to 0ou b0
Second Sight.
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$ccessor) Description
3atter0
Charger
De-leted batteries can be
recharged b0 using the batter0
charger that is -rovided *ith
the rgus II S0ste$.
8U ouch <he -ouch allo*s the 8U to
be *orn on the bod0. It can be
ad@usted to hold the 8U in the
$ost co$fortable orientation.
(l asses
<he glasses? *hich are $ade of -lastic? have a
$iniature video ca$era in the bridge above thenose and a coil on one of the ear-ieces? *hich is
used to -o*er and co$$unicate *ith the i$-lant.
<he glasses are connected to the 8U b0 a cable.
See igure /.
<able ! -rovides a descri-tion of the co$-onents
that $ae u- the glasses and their associated
accessories.
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igure 4: (lasses for the ight 0)e
Cable Ca$era
Glasses Coil
Table 3: (lasses Components an%
$ccessories
Component Description
Glasses <he glasses -rovide a
convenient and discreet *a0 to
house the video ca$era and the
coil needed to -o*er andco$$unicate *ith the i$-lant.
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Component Description
Ca$era $iniature video ca$era is
$ounted in the center of the
glasses fra$e? directl0 above the
nose bridge. When the s0ste$ is
o-erating? the ca$era conve0s a
stead0 strea$ of video i$ages to
the 8U? via a cable.
Glasses Coil <he glasses coil contains the
receiver and trans$itter
antennae. <he coil is $ounted to
the te$-le of the glasses on the
side *here the i$-lant is
located. It is used to
co$$unicate *irelessl0 *ith the
i$-lant.
Cable
Cable(continued)
<he cable -rovides a connection
bet*een the glasses and the
8U. <he cable has threefunctions= (1) <o -o*er the
ca$era and conve0 video
signals fro$ the ca$era to the
8UE (2) <o send data and
-o*er fro$ the 8U to the
glasses coilE and (!) <o conve0i$-lant status infor$ation fro$
the glasses coil to the 8U.
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Component Description
<he cable is -art of the glasses
asse$bl0 and cannot be
re$oved fro$ the glasses.
If the cable breas or
$alfunctions? the glasses should
be re-laced. Contact 0our
clinician or Second Sight usingthe infor$ation -rovided in
Cha-ter & for re-lace$ent -arts.
<ravel Case durable case is -rovided to
safel0 store and trans-ort the
8U? glasses and batteries *hennot in use. See igure ".
igure ": Travel Case
Glasses
8U
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$rgus II +)stem *ireless Informati on
<he rgus II Glasses use *ireless technolog0 toco$$unicate *ith and -o*er the I$-lant. <able /
su$$ariJes infor$ation about the *ireless
technolog0 used in the rgus II S0ste$.
Table 4: *ireless Technolog) Information
Details
;o* to chieve
Wireless 4in *ith
the Glasses
Wear the glasses as 0ou
*ould a nor$al -air of
glasses. ,our clinician *ill
-osition the glasses coil to
ensure that it *ill have good*ireless lin *ith the i$-lant.
<he glasses and the i$-lant
*ill auto$aticall0 connect and
o-erate *hen the glasses are
-laced on 0our head and the
8U is turned on. 'efer toWearing the Glasses on
-age "2 for $ore details.
Wireless S-ecifications=
re6uenc0
(to the i$-lant)
!.1"& %egahertJ (%;J.)
re6uenc0 /7! /:+ HilohertJ (H;J.)
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Details
(fro$ the i$-lant)
3and*idth (to the
i$-lant)
1! HilohertJ (H;J.)
3and*idth (fro$
the i$-lant)
2+ HilohertJ (H;J.)
o*er
(to the i$-lant)
$-litude $odulation (%)
4ess than 1.2 *atts
o*er
(fro$ the i$-lant)
re6uenc0 shift e0ing (SH)
4ess than 1+ $icro*atts
Wireless 4inerfor$ance
Wireless lin active $ore than:+F of the ti$e *hen the coil
is a--ro5i$atel0 1 inch or
closer to the i$-lant.
or <roubleshooting regarding
lin loss? refer to -age 77.
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Details
Wireless Securit0 <he *ireless s0ste$ is
designed so the i$-lant *ill
onl0 o-erate if it is *ithin a
ver0 short distance of the
glasses. <he rgus II S0ste$
uses a -ro-rietar0
co$$unication -rotocol toreduce the lielihood of
inadvertent control or
$alicious hacing of the
S0ste$. No identifiable
-ersonal data are trans$itted
b0 the rgus II S0ste$.
Interference related
to the *ireless
s0ste$
C$TI7,: efer to the
Possible Interference /ith
7ther 0lectronic Devices
section on page 1>.
$rgus II Patient Catalog
<he follo*ing ite$s are included in 0our rgus II
'etinal rosthesis atient Catalog=
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Table ": Patient Catalog
Description Catalog ?Pro%uct
,umber
rgus II 8ideo rocessing Unit
including atient %anual
+1!++!
8U 3atteries=
S$all batter0
Son0 Info4I<;IU% % Series
%odel Nu$ber N9%"++;
%ediu$ batter0
Son0 Info4I<;IU% % Series
%odel Nu$ber N9K%71D
1++2++9++1
1++2++9++2
rgus II Glasses=
/ -ossible configurations
Glasses? 'ight #0e? Dar 4enses
Glasses? 'ight #0e? Clear 4enses
Glasses? 4eft #0e? Dar 4enses
Glasses? 4eft #0e? Clear 4enses
+12+11
+12+12
+12+1!
+12+1/
8U 3atter0 Charger 1++2++9++/
rgus II <ravel Case +12:!+
rgus II 8U ouch +1!:!1
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Chapter 3: Preparing for Your
Device
Implantation +urger)
3elo* is general infor$ation about ho* the rgus
II S0ste$ is i$-lanted. ,our doctor *ill -rovide
0ou *ith $ore s-ecific infor$ation.
1. <*o da0s before surger0? 0ou $a0 be
instructed to start taing antibiotics.
2. n the da0 of surger0? 0ou *ill be ad$itted to
the hos-ital. <he surgical -rocedure *ill
generall0 last four hours? but it $a0 be shorter or longer. During the i$-lant -rocedure? 0ou
*ill undergo general anesthesia.
3. If 0ou have a natural lens in 0our e0e? the
surgeon *ill re$ove it before inserting the
i$-lant. If 0ou have an intraocular lens in 0our e0e? the surgeon *ill liel0 leave it in -lace.
4. <he con@unctiva (the thin tissue that covers the
*hite -art of 0our e0e) *ill be -ulled bac. If
0our e0e orbit is s$all? the surgeon $a0 need
to $ae a s$all cut at the outer corner of the
e0elids to $ae it easier to -lace the device.
". <he surgeon *ill then -lace the i$-lant around
0our e0e. It *ill be ad@usted and -ositioned to
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fit snugl0 against 0our e0e. <he band on the
i$-lant *ill be secured around 0our e0e using
a s$all -lastic sleeve. Stitches *ill be -lacedon the i$-lant to hold it in -lace on 0our e0e.
#. <he surgeon *ill then $ae s$all hole in the
*all of 0our e0e and *ill re$ove all of the gel9
lie fluid inside 0our e0e. <he fluid *ill be
re-laced *ith a saline solution.
'. If 0ou have a thin la0er of tissue over 0our
retina? 0our surgeon $a0 re$ove this b0 gentl0
-eeling it off the retina.
&. ,our surgeon *ill then attach the electrode
arra0 of the i$-lant to 0our retina *ith a tac.<he i$-lant *ill then be tested to ensure that it
is functioning -ro-erl0.
!. If the device is functioning -ro-erl0? all of the
cuts in 0our e0e *ill be closed and a thin la0er
of tissue (fro$ a hu$an donor) *ill be -laced
over a s$all -ortion of the i$-lant on the
outside of 0our e0e.
1>. <he con@unctiva (the thin tissue that covers the
*hite -art of 0our e0e) *ill be closed *ith
stitches that *ill dissolve over ti$e.
11. ,our e0e *ill be -atched and 0ou *ill be
escorted to the recover0 roo$.
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12. fter 0ou recover fro$ surger0? 0ou *ill be
discharged fro$ the hos-ital *ith instructions
to tae a -rescribed oral $edication and usee0e dro-s to control s*elling? infection? and
-ain. ,ou *ill -robabl0 not need to s-end the
night in the hos-ital.
13. ,ou *ill need to return to the hos-ital the ne5t
da0 so the doctor can chec 0our e0e. ,ou *ill
return to the hos-ital one *ee later to have
0our e0e checed again. t this ti$e? if the
doctor feels that 0ou have recovered
ade6uatel0 fro$ 0our surger0? fitting and
-rogra$$ing of the device $a0 begin.
Post=Implant Care
fter 0ou are i$-lanted *ith the rgus II I$-lant?
0ou *ill need to return several ti$es to the clinic
for clinical follo*9u-? device fitting and
-rogra$$ing? and visual rehabilitation. #ach of
these is described in $ore detail belo*. ,ou
should consider living close enough to the clinic?
or be *illing to te$-oraril0 relocate closer to the
clinic? to allo* 0ou to full0 -artici-ate in the
reco$$ended follo*9u-.
Clinical oll o/ =p
,ou *ill need to return to the hos-ital -eriodicall0
so that the doctor can chec the health of 0our
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e0e. <hese -eriodic visits *ill continue as long as
the rgus II i$-lant re$ains in 0our e0e.
Device it ting an% Programming
fter the i$-lant surger0? 0ou are about to start
the e5citing and long @ourne0 of living and *oring
*ith 0our rgus II S0ste$. irst? the s0ste$ *ill
need to be -rogra$$ed? or fitted? in order for
0ou to see an0thing fro$ the device.
Initial ittin g Sessions
<he -ur-ose of the initial fitting sessions is si$-le=
to find suitable sti$ulation levels across all of the
electrodes so that the first visual -rogra$ can be
set on 0our 8U. <his is achieved b0 having 0ou
co$e to the clinic *here 0our video -rocessing
unit (8U) *ill be connected to a s-ecial
co$-uter. ,our clinician *ill use the soft*are to
co$$and the i$-lant to -rovide electrical
sti$ulation. ,our res-onse to the sti$ulation *ill
be recorded and used to create custo$ -rogra$s
that can be do*nloaded to 0our 8U for 0ou to
use in 0our ever0da0 life.
re-aring for Using t he rgus II S0ste$ at ;o$e
nce the -rogra$s are created and do*nloaded
to the 8U? the device can be connected to the
glasses? turned on and 0ou *ill start to -erceive
s-ots of light? also no*n as -hos-henes? fro$ the
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device. <he video signal is ca-tured b0 the
ca$era $ounted on the glasses. <he ca$era *ill
be ad@usted b0 0our clinician to line u- *ith ho*the i$-lant is -ositioned inside 0our e0e.
,ou *ill also be trained on ho* to connect the
glasses to the 8U? ho* to o-erate the controls
and s*itches on the 8U? ho* to understand the
alar$s and 4#D lights? si$-le troubleshooting?
and care and $aintenance of 0our rgus II
S0ste$.
Several of these fitting and training sessions $ust
be conducted over the course of /9& *ees
follo*ing the surger0 before 0ou can use the
s0ste$ at ho$e. <0-icall0? -atients in the clinicaltrial started ho$e use of the s0ste$ one to three
$onths after their i$-lant surger0.
ollo*9u- rogra$$ing
fter the initial fitting sessions? 0ou $a0 need to
visit 0our clinician on a regular basis in order to
fine9tune the -rogra$. If 0our -erce-tual
e5-erience *ith the device changes? 0ou should
contact 0our clinician for a follo*9u- -rogra$$ing
session.
5isual eh abili tation
ollo*ing device i$-lantation? it is ver0 i$-ortant
to -artici-ate in the reco$$ended visual
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rehabilitation -rogra$. <his rehabilitation -rogra$
is designed to allo* 0ou to i$-rove 0our abilit0 to
-erfor$ dail0 activities and reach 0our goals *iththe rgus II S0ste$.
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Chapter 4: sing Your Device
+etup Instructions
<o set u- the e6ui-$ent for use? follo* the
instructions belo*.
1. Charge the batter). 3efore first use of a
batter0? charge it full0. <o charge the batter0?
-lug in the batter0 charger and -lace the
batter0 in the rece-tacle of the charger. It taes
a--ro5i$atel0 three hours to full09charge a
batter0. <he follo*ing can be checed b0 a
sighted individual. When the batter0 is
charging? the orange charge light is on. Whenthe batter0 is full0 charged? the light *ill be off.
2. Install the batter). <o install the rechargeable
batter0? slide the 8U batter0 latch so that it
o-ens (as sho*n in igure & belo*). While
holding the latch o-en? slide the batter0 in therece-tacle a*a0 fro$ the latch until the batter0
latch auto$aticall0 slides into its loced
-osition.
3. emove the batter). <o re$ove the batter0?
slide the 8U batter0 latch so that it o-ens
(to*ard the to- of the 8U). ;olding the latcho-en? slide the batter0 as far as 0ou can
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to*ard the latch and lift it out of the rece-tacle.
'elease the latch.
igure #: ;atter) <atch ;eing @el% 7pen
4. Confirm proper installation of the batter).
Confir$ that the batter0 is -ro-erl0 installed b0
gentl0 -ulling it. If the batter0 co$es loose? it
*as not -ro-erl0 installed. erfor$ Ste- 2again to -ro-erl0 re9install the batter0.
C$TI7,: Do not use an) batteries /ith
the 5P other than those supplie% b)
+econ% +ight. se of other batteries ma)
%amage the 5P or cause it to function
improperl) an% voi% the manufacturerAs
/arrant).
". *earing the 5P. lace the 8U in the -ouch
and loc it in -lace using the 8elcroL
stra- near
the right side of the 8U ne5t to the star9
sha-ed button. Insert the batter0 into therece-tacle and secure the 8U in -lace *ith
the other 8elcro stra-. <he 8U -ouch can be
*orn on the bod0.
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#. Connecting the glasses to the 5P. <he
glasses are e6ui--ed *ith a cable that is
inserted into the glasses rece-tacle located onthe to- of the 8U. <o connect the glasses to
the 8U? -erfor$ the follo*ing ste-s=
(a) l*a0s $ae sure the 8U is turned off
before connecting the glasses.
(b) Gras- the cable and hold it b0 the rubber
-iece at the end. Notice that the rubber
-iece $aes an 49sha-e. <his 49sha-e
aids in -ro-er orientation of the -lug.
(c) 4ocate the round9sha-ed glasses
rece-tacle on the 8U.
(d) Insert the cable -lug into the glasses
rece-tacle. #nsure that the cable end of the -lug is -ointed to*ards the right side of
the 8U *here the circular -o*er button is
located. --l0 -ressure to insert the -lug
into the glasses rece-tacle. If the -lug
does not insert? gentl0 rotate it for -ro-er
align$ent *hile tr0ing to insert it. ncealigned? the -lug *ill insert into the glasses
rece-tacle.
(e) ush the -lug fir$l0 into the rece-tacle
until 0ou hear a clic. Note that the -lug
does not loc.
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'. Disconnecting the glasses from the 5P.
l*a0s turn the 8U off before disconnecting
the glasses. If 0ou need to disconnect theglasses fro$ the 8U? hold the 8U fir$l0 in
one hand. Using the other hand? gras- the
49sha-ed -lug at the end of the glasses cable
and gentl0 -ull it straight a*a0 fro$ the 8U.
C$TI7,: Do not pull the glasses cable
out of the 5P at an angle as this ma)
%amage the receptacle or the 5P.
&. *earing the glasses. Using both hands?
gentl0 -ut on the glasses as 0ou *ould a
nor$al -air of glasses. d@ust the cable so that
it is co$fortable and does not catch onan0thing such as 0our ar$s or clothes. <he
cable $a0 be threaded inside 0our clothing to
-revent it fro$ getting caught on ob@ects *hile
0ou $ove.
C$TI7,: Do not a%Bust the position of
the glasses coil. The coil position is set
b) )our clinician or +econ% +ight
personnel to optimi8e performance of
the %evice. Changing the coil position
ma) cause loss an%?or interruption of
stimulation. Contact )our clinician if
)our 5P au%ible alarm beeps
freuentl).
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C$TI7,: se care /hen putting on the
glasses. Do not over=e6ten% the glasses
arms as this coul% brea9 them.
C$TI7,: Do not attempt to a%Bust the
camera mounte% on the glasses as it
ma) cause %amage or misalignment of
the camera.
7perating Instructions
C$TI7,: Do not e6change )our 5P /ith
another patientAs 5P. 0ach 5P is
programme% for one patient an% can cause
uncomfortable stimulation if use% b)
another patient.
C$TI7,: If )ou e6perience an) %iscomfort
%uring the use of the %evice please contact
)our clinician or +econ% +ight promptl).
<o use the 8U and glasses? follo* the
instructions belo*.
1. <ighting Con%itions. <he rgus II S0ste$
uses the ca$era in the glasses to ca-ture the
video i$age that is sent to 0our i$-lant. Since
the ca$era does not *or *ell in di$l0 lit
environ$ents? it is i$-ortant to $ae sure that0ou have enough light in 0our surroundings
*hen 0ou are using the S0ste$. If 0ou are
inside? 0ou should al*a0s $ae sure the lights
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are on in the roo$. It is also reco$$ended that
a sighted individual confir$ that 0our lights are
*oring -ro-erl0.
2. Turning on the 5P. ut the glasses on as
described above. <o turn on the 8U? -ress
the circular -o*er button on the side of the
8U and hold it do*n for a--ro5i$atel0 t*o
seconds until 0ou hear four short bee-s.
3. +)stem start=up tests. I$$ediatel0 after the
8U is turned on? the s0ste$ -erfor$s a series
of tests. <hese tests last a--ro5i$atel0 !+
seconds. During this ti$e the green indicator
light *ill blin 6uicl0. ,ou $a0 or $a0 not see
so$ething during these tests. nce these testsare co$-lete? sti$ulation *ill begin and the
green indicator light *ill blin $ore slo*l0
(1blin -er second) to indicate that the s0ste$
is o-erating -ro-erl0.
4. Possible clic9ing noise from the glasses
coil. <his is -art of the nor$al o-eration of the
s0ste$ and does not indicate a failure of an0
ind.
". Changing program settings. <he 8U has !
-rogra$ settings that are selectable b0
-ressing one of the three oval9sha-ed buttonson the front of the 8U. <he oval9sha-ed
button *ith a single circle corres-onds to
rogra$ Setting 1. <he button *ith t*o circles
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corres-onds to rogra$ Setting 2 *hile the
oval button *ith a s$all bar corres-onds to
rogra$ Setting !. <he user $a0 change the-rogra$ being used to suit different lighting or
contrast conditions. When the 8U is first
turned on it defaults to rogra$ Setting 1.
#ach ti$e the rogra$ Setting is changed the
8U *ill -roduce a short bee-.
#. Inverting the image. <o invert the i$age fro$
blac9to9*hite and *hite9to9blac? -ress the
s6uare button located in the $iddle of the right9
hand side of the 8U. #ach ti$e the button is
-ressed? the i$age *ill invert and the 8U *ill
bee-.
'. $u%ible lin9 alarm. <he star9sha-ed
button ne5t to the inverse button is a toggle
s*itch for turning onAoff the 8U audible alar$
that indicates *hen the co$$unication lin
*ith the i$-lant has been te$-oraril0 lost.
&. Turning off the 5P. <o turn off the 8U?
-ress the -o*er button and hold it do*n for
a--ro5i$atel0 one second. ne bee- follo*ed
b0 a -ause? follo*ed b0 t*o short bee-s *ill
signal that the s0ste$ is turning off. nce the
8U is off? all indicator lights on the 8U *ill
be off.
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<0D In%icators an% $u%ible $larms
<he 8U uses both visual and audible indicatorsto -rovide infor$ation about the status of the 8U
and glasses and -roble$s that can occur *ith the
rgus II S0ste$. <able " and <able & su$$ariJe
the $eaning of these indicators. <heir location on
the 8U is sho*n in igure 7 belo*.
igure ': 5P <0D In%icator Colors
$ber 4#D
Green
4#D
range4#D
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Table #: <0D In%icators
<0DColor
<ightflashing
eaning
Green ast
-eriodic
blining
<he 8U is going
through s0ste$
start9u- diagnostic
testing.
Green Slo*
-eriodic
blining
(1 -er
second)
<he 8U is
o-erating nor$all0.
range Solid <here is a -roble$*ith the video
signal. (or
e5a$-le? the
glasses cable is
not connected to
the 8U).
$ber Solid <here is a loss of
co$$unication
bet*een the
i$-lant coil and
glasses coil.
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<0D
Color
<ight
flashing
eaning
$ber 3lining <here is
inter$ittent
co$$unication
bet*een the
i$-lant coil and
the glasses coil.
Table ': $u%ible $larms
+oun% eaning
Single short bee- button has been
-ressed (for e5a$-le?
a rogra$ Setting or
Inverse Setting
3utton).
ne bee- follo*ed b0
a -ause? follo*ed b0
t*o short bee-s
<he 8U is turning
off.
our short bee-s <he 8U is starting
u-.
<hree short bee-s n error has occurred
and the 8U is about
to shut do*n
auto$aticall0.
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+oun% eaning
eriodic bee-ing
-attern (! short
bee-s follo*ed b0
1 long bee-? follo*ed
b0 ! short bee-s?
follo*ed b0 a long
-ause)
<he batter0 level is
lo*.
Slo* -eriodic bee-
(1 ever0 2 seconds)
<here is a -roble$
*ith the video signal.
ast -eriodic bee-
(2 -er second)
<here is a loss of
co$$unication
bet*een the i$-lant
coil and glasses coil.<his alar$ can be
turned off b0 -ressing
the star9sha-ed
button on the right
side of the 8U (the
udible ' 4in lar$ 3utton).
;att er ) <if e
ctual batter0 life $a0 var0 based on settings?
usage -atterns? and environ$ental conditions. n
average? the s$all rechargeable batter0 *ill last
2." to !." hours and the $ediu$ batter0 *ill last /
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to & hours before needing to be recharged. 3atter0
ca-acit0 *ill dro- graduall0 over ti$e *ith use of
the s0ste$. When the available batter0 ti$e isshortened considerabl0? a -robable cause is that
the batter0 has reached the end of its life. Contact
0our clinician or Second Sight for a re-lace$ent
batter0.
echargin g the ;atteries
ne s$all rechargeable batter0? one $ediu$
rechargeable batter0 and one batter0 charger are
-rovided *ith the rgus II S0ste$. ollo* the
instructions su--lied *ith the charger to recharge
the batter0. dditional batteries $a0 be -urchased
fro$ Second Sight.
Chec9ing the unction of the Device
It is i$-ortant to -eriodicall0 chec the rgus II
S0ste$ for nor$al *ear and tear. If 0ou notice an0
e5-osed *ires on the glasses or loose or broen
-arts on the glasses or 8U? contact 0our doctor.
In addition? if 0ou notice a decline in the lin
bet*een the i$-lant and glasses (for e5a$-le? if
the ' lin alar$ is bee-ing $ore fre6uentl0 than
nor$al)? contact 0our doctor.
Cleaning
<o clean the batter0 contacts? follo* the
instructions in the batter0 -acage.
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<o clean 0our 8U? glasses or cables? follo* the
instructions belo*=
1. Use a clean? slightl0 da$- cloth to clean the
e6ui-$ent. Gentl0 rub the areas that re6uire
cleaning.
2. Use a clean? dr0 cloth to dr0 the e6ui-$ent
after cleaning it.
3. Use a can of co$-ressed air to re$ove dust
and debris fro$ the s0ste$. Use the
co$-ressed air as directed b0 the
$anufacturer.
4. Use a soft cloth to re$ove $inor s$udges and
finger-rints fro$ the glasses and ca$era lens
on the glasses.
C$TI7,: Do not use an) cleaning
solutions or solvents to clean the
euipment as this ma) %amage the
euipment or its labels.
aintenance
<he rgus II S0ste$ does not contain an0 user
serviceable -arts.
C$TI7,: Do not attempt to service
open repair or con%uct maintenance on
an) of )our euipment as )ou ma)
e6perience an inBur) violate the pro%uct
/arrant) or %amage the euipment.
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C$TI7,: Contact )our clinician or
+econ% +ight using the contact
information provi%e% in Chapter ' if )our euipment reuires maintenance or is
not /or9ing properl).
@an%ling an% +torage
<ae care *hen storing and handling the 8U and
glasses. I$-ro-er care or storage can result inda$age to the e6ui-$ent. ollo*ing the
guidelines belo* can i$-rove the lifeti$e of this
e6ui-$ent.
1. agneticall)=sensitive storage %evices. Do
not -lace $agneticall09sensitive storage
devices (credit cards? co$-uter flo--0 diss or
hard diss) near the rgus II S0ste$ *hile it is
o-erating. <he electro$agnetic field generated
b0 the o-erational s0ste$ $a0 corru-t the
infor$ation stored on such devices.
2. etal obBects. Do not allo* an0 $etal ob@ects*ithin & inches (1".2 c$) of the glasses coil
*hile the 8U is in use. Should this ha--en?
the 8U *ill detect the -ossibilit0 of this coil
overheating and turn off. <he 8U *ill not *or
until reset b0 trained -ersonnel.
3. napprove% components. Use onl0
co$-onents and accessories su--lied b0
Second Sight *ith the rgus II S0ste$. <he
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use of una--roved co$-onents $a0 cause
da$age to the e6ui-$ent? resulting in loss of
sti$ulation andAor in@ur0. It *ill also void the$anufacturerBs *arrant0.
4. 06posure to liui%. Do not e5-ose the 8U
and glasses to *ater (for e5a$-le? rain?
sho*er? s*i$$ing -ool? or ocean) or other
li6uids as the0 $a0 da$age the e6ui-$ent.
<he glasses $a0 be e5-osed to light rain? but
the 8U $a0 not.
". +torage of the $rgus II 5P an% (lasses.
Store the -acaged rgus II 8U and glasses
at te$-eratures bet*een !2 (+MC) and 11!
(/"MC). Do not e5-ose the e5ternal e6ui-$entto te$-eratures belo* !2 or above 11! as
this $a0 result in da$age that renders the
device ino-erable.
#. sage temperature range. <he te$-erature
range for nor$al use should be bet*een !2 (+MC) and 1+/ (/+MC).
'. @an%ling the glasses. <he glasses are fragile.
;andle the$ *ith care? es-eciall0 *hen -utting
the$ on or taing the$ off. Do not over9e5tend
the ar$s of the glasses *hen -utting the$ on
or taing the$ off as this $a0 brea the$. Donot fold the ar$s of the glasses to shut the$.
<he ar$s are not designed to be closed and
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tr0ing to fold the$ $a0 brea the$. Use care
*hen attaching or re$oving an0 cables or
-lugs as rough handling can da$age thecables or e6ui-$ent. Do not *ra- the cable
around the 8U since? over ti$e? this $a0
cause da$age to the cable.
&. Traveling /ith the e6ternal %evices. It is
reco$$ended that 0ou store the 8U? glasses?
and batteries in the travel case -rovided b0
Second Sight as this is designed to -rotect the
e6ui-$ent. It is also reco$$ended that 0ou
uninstall the batter0 fro$ the 8U during
transit? to avoid accidentall0 turning on the
8U *hich could drain the batter0. Do not
-lace an0thing on to- of the glasses or 8U.
!. <oss of lin9. <he rgus II I$-lant is driven
b0 the e5ternal coil housed on the rgus II
Glasses. Shifting the rgus II Glasses outside
the range of the rgus II I$-lant $a0 result in
a decrease or loss of sti$ulation. dditionall0?0ou $a0 need to restrict 0our e0e $ove$ents
to $aintain the lin bet*een the i$-lant coil
and glasses coil.
1>. Interference. <he rgus II S0ste$ $a0
interfere *ith certain radiofre6uencies. If
interference occurs? 0ou should e5tend the
distance bet*een 0ou and the source of
interference? or turn off the rgus II 8U.
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06pecte% ailure Time an% o%e an% Its
0ffect on You
<he rgus II I$-lant *as designed to o-erate for
at least five 0ears? and laborator0 testing has
de$onstrated that the design is ca-able of that
lifeti$e. Insufficient ti$e has ela-sed in actual
clinical use to -rovide -roof that the device *ill
function -ro-erl0 for $ore than five 0ears? but-erfor$ance to date and laborator0 testing
suggest that it *ill.
ne -ossible failure $ode of the i$-lant is that it
could sto- res-onding to signals fro$ the glasses
and thus sto- sti$ulating. If it fails in this $anner?
0ou should not e5-erience an0 har$ful effects.
<he i$-lant $a0 be safel0 re$oved and re-laced
if desired.
<he e5ternal e6ui-$ent (8U and glasses) are
$uch $ore susce-tible to handling and breaage
than the i$-lant. <his e6ui-$ent $a0 be re-lacedif necessar0.
Wearout failure of the rechargeable batter0 is
described in the -erating Instructions section of
this cha-ter.
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Instructions on @o/ to +afel) Dispose
of the Device
*$,I,( During transport storage an%
han%ling for %isposal the
follo/ing safet) precautions
shoul% be consi%ere%:
Do not %ispose of the 5P
batteries or the batter) charger
in a fire as this ma) cause an
e6plosion an%?or the release of
to6ic fumes.
Do not %ismantle the batter) as
some ingre%ients can beflammable or harmful.
+tore use% batteries for %isposal
in a clean %r) environment out of
%irect sunlight an% a/a) from
e6treme heat. Dirt an% /etness
ma) cause short=circuits an%
heat. @eat ma) cause lea9age of
flammable gas /hich ma) result
in fire rupture or e6plosion.
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*$,I,(+tore use% batteries in a /ell=
ventilate% area. If use% batteries
are short=circuite% abnormall)=charge% or force=%ischarge%
lea9age of flammable gas ma)
be cause% possibl) resulting in
fire rupture or e6plosion.
Do not mi6 use% batteries /ith
other materials. If the batteries
are short=circuite% abnormall)=
charge% or force=%ischarge% the
heat generate% ma) ignite
flammable /astes an% cause a
fire.
5P an% (l asses
ollo* local and state regulations regarding the
-ro-er dis-osal of electronics to dis-ose of the
8U or glasses. If an e5change or re-lace$ent of
e6ui-$ent is occurring through 0our clinician? the0
*ill ensure that the e6ui-$ent is -ro-erl0 returned.
echargea ble ;atteries an% ;atter ) Charger
<he 8U uses rechargeable batteries. If 0ou
detect an0 leaage of fluid fro$ the batter0? sto-
using it and re-lace it *ith a ne* one. Dis-ose of
a batter0 or batter0 charger *hen it reaches the
end of life. ollo* -rocedures that co$-l0 *ith
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0our local regulations and the -acage insert of
the batter0 or batter0 charger for -ro-er dis-osal
$ethods.
$rgus II Implant
If the rgus II I$-lant is e5-lanted for an0 reason?
Second Sight $ust be contacted first e5ce-t in the
event of $edical e$ergenc0. <he e5-lanted unit
$ust be returned to Second Sight for evaluation?
*arrant0 -ur-oses and final dis-osition. ,our
clinician should re6uest a biohaJard (e5-lant) it
fro$ the Second Sight office (see contact
infor$ation in Cha-ter 7).
Disposal of Pac9aging aterial
<he shi--ing carton for the rgus II S0ste$
co$-onents or accessories? and -acaging
$aterials should be dis-osed of according to local
regulations.
Cha-ter /= Using ,our Device age &:
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Chapter ": Troubleshooting
If 0ou encounter a -roble$ *ith an0 -art of 0our
s0ste$? loo for the -roble$ in <able belo*.
Instructions for ho* to fi5 the -roble$ are -rovided
in the table.
If 0ou cannot find the -roble$ in the tables belo*
or if the reco$$endations do not fi5 the -roble$?
then contact 0our clinician or use the infor$ation
-rovided in Cha-ter 7 of this $anual to contact
Second Sight.
C$TI7,: If )ou encounter a clinical or
ph)sical problem -such as chronic e)epain or %iscomfort relate% to the $rgus II
+)stem please contact )our clinician
imme%iatel).
Table &: Troubleshooting
+)mptom Cause an%?or Corrective
$ction
<he 8U does
not start
1. Chec that the batter0
is installed -ro-erl0. If it
is not installed
-ro-erl0? refer to
instructions in Cha-ter
/? Install the batter0.
Cha-ter "= <roubleshooting age 7+
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+)mptom Cause an%?or Corrective
$ction
<he 8U does
not start
(continued)
2. Install a full09charged
batter0. 'efer to
instructions -rovided in
Cha-ter /? Install the
batter0.
!. #nsure that 0ou are
-ressing the correctbutton. <he -o*er
button is the circular9
sha-ed one on the
right side -anel of the
8U (see igure !).
/. #nsure that 0ou are-ressing the -o*er
button for at least t*o
seconds. If the button
is -ressed for less than
t*o seconds? the 8U
*ill not turn on.
<he 8U
-roduces an
audible *arning
(three short
bee-s) and
shuts off
suddenl0
<urn on the 8U to
see if this occurs
again. If the -roble$
-ersists? contact either
0our clinician or 0our
Second Sight
re-resentative.
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+)mptom Cause an%?or Corrective
$ction
<he 8U
shuts off
suddenl0
*ithout an
audible
*arning
1. Install a full09charged
batter0. 'efer to
instructions Install the
batter0 -rovided in
Cha-ter /.
2. <urn on the 8U to
see if this occursagain.
!. If the 8U fails to
restart? re$ove the
batter0 for at least "
$inutes. <hen? install
again./. ut on glasses. <urn
on the 8U again and
sti$ulation should
restart.
". If the -roble$ -ersists
or occurs again
rando$l0 *hen the
batter0 is charged?
contact either 0our
clinician or 0our
Second Sight
re-resentative for
advanced
troubleshooting.
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+)mptom Cause an%?or Corrective
$ction
<he 8U is
on? but I donBt
see an0thing
1. Confir$ that the 8U
is on b0 -ressing an0
button on the 8U
other than the -o*er
button. If a bee- is
heard? then the 8U is
on.2. #nsure that the 8U is
not $aing an0 audible
alar$s. Chec if the
audible ' lin alar$
s*itch is on. If it is?
chec that the glassescable is -ro-erl0
-lugged into the 8U
glasses rece-tacle.
!. Gentl0 -ress the coil
$ounted on the
glasses closer to 0our
e0e. If the audible
alar$ sto-s bee-ing
and resu$es bee-ing
*hen 0ou sto-
-ressing the coil? this
indicates that 0our
e5ternal coil needs to
be ad@usted to ensure
the co$$unication
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+)mptom Cause an%?or Corrective
$ction
<he 8U is
on? but I donBt
see an0thing
(continued)
bet*een the e5ternal
coil and the i$-lant is
reliable.
/. #nsure that nothing is
blocing the ca$era
on the glasses. If there
is so$ething blocingthe ca$era? tr0 to
re$ove the
obstruction.
". #nsure that the lens on
the ca$era is clean.
'efer to Cleaning inCha-ter /.
&. #nsure that 0our
surroundings have
ade6uate lighting.
7. <r0 inverting the i$age
(fro$ blac9to9*hite or
*hite9to9blac) b0
-ressing the s6uare9
sha-ed settings
button.
. <r0 changing the
-rogra$ setting.
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+)mptom Cause an%?or Corrective
$ction
<he 8U is
on? but the
i$age see$s
distorted
1. #nsure that nothing is
blocing the ca$era
on the glasses.
2. #nsure that the lens on
the ca$era is clean.
'efer to Cha-ter /?
Cleaning.!. <r0 using one of the
other -rogra$ settings
to see if there is an
i$-rove$ent.
<he 8U is
on? but $0-erce-tion is
di$$er than
usual
1. #nsure that nothing is
blocing the ca$eraon the glasses. If there
is so$ething blocing
the ca$era? tr0 to
re$ove the
obstruction.
2. #nsure that the lens onthe ca$era is clean.
'efer Cha-ter /?
Cleaning.
!. #nsure that 0our
surroundings have
ade6uate lighting.
/. #nsure that 0ou are
using the correct
sti$ulation setting.
Cha-ter "= <roubleshooting age 7"
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+)mptom Cause an%?or Corrective
$ction
<he 8U is
on? but $0
-erce-tion is
di$$er than
usual
(continued)
S*itch bet*een the
nor$alAinvert settings
b0 -ressing the
s6uare9sha-ed invert
button.
". #nsure that the
intended rogra$Setting is being used
to -rovide the o-ti$u$
-erce-tion b0
e5-eri$enting *ith the
different rogra$
Setting buttons.&. S*itch off the 8U for
1+ $inutes and s*itch
it bac on.
<he coil on
the glasses
see$s*ar$er than
usual
'e9ad@ust the glasses
to see if the coil cools
do*n to its usualo-erating te$-erature.
If the -roble$ is
-ersistent or the coil is
getting unusuall0
*ar$? contact Second
Sight using the contact
infor$ation -rovided in
Cha-ter 7.
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+)mptom Cause an%?or Corrective
$ction
<here is a
clicing noise
fro$ the area
of the coil on
the glasses
<his is -art of the
nor$al o-eration of the
s0ste$ and does not
indicate a failure of an0
ind.
Nose-iece
co$es off the
glasses
1. <urn the glasses over
and la0 the$ on a flat
surface so that the to-
of the fra$e is in
contact *ith surface.
2. <ae the nose-iece and
-lace it on the
underside of the lens*here the nose-iece
should be attached.
!. ress fir$l0. <his
should loc the
nose-iece bac in
-lace.
If the -roble$ -ersists? contact 0our clinician or
use the infor$ation in Cha-ter 7 to contact
Second Sight.
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