003 patient manual redacted

8/10/2019 003 Patient Manual Redacted

http://slidepdf.com/reader/full/003-patient-manual-redacted 1/86



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............................................ /"



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) ......................................... !"



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.

Cha-ter 1= I$-ortant Infor$ation age 1



*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.




> ;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

Cha-ter 1= I$-ortant Infor$ation age !



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

Cha-ter 1= I$-ortant Infor$ation age /



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.

Cha-ter 1= I$-ortant Infor$ation age "



> 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

Cha-ter 1= I$-ortant Infor$ation age &



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.




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

Cha-ter 1= I$-ortant Infor$ation age



-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.

Cha-ter 1= I$-ortant Infor$ation age :



> <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

Cha-ter 1= I$-ortant Infor$ation age 1+



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




*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




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

"+&+.

Cha-ter 1= I$-ortant Infor$ation age 1/



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

Cha-ter 1= I$-ortant Infor$ation age 1"



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

Cha-ter 1= I$-ortant Infor$ation age 1&



<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




> -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




> ,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

Cha-ter 1= I$-ortant Infor$ation age 2+



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




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.




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.

Cha-ter 2= Device Descri-tion age 2!



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*.

Cha-ter 2= Device Descri-tion age 2/



$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.

Cha-ter 2= Device Descri-tion age 2"



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.

Cha-ter 2= Device Descri-tion age 2&



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)

Cha-ter 2= Device Descri-tion age 27



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

Cha-ter 2= Device Descri-tion age 2



*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.

Cha-ter 2= Device Descri-tion age 2:



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.

Cha-ter 2= Device Descri-tion age !2




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.

Cha-ter 2= Device Descri-tion age !!




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.

Cha-ter 2= Device Descri-tion age !/



$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.

Cha-ter 2= Device Descri-tion age !"



igure 4: (lasses for the ight 0)e

Cable Ca$era

Glasses Coil

Table 3: (lasses Components an%

$ccessories


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.

Cha-ter 2= Device Descri-tion age !&




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.

Cha-ter 2= Device Descri-tion age !7




<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

Cha-ter 2= Device Descri-tion age !



$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.)

Cha-ter 2= Device Descri-tion age !:



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.

Cha-ter 2= Device Descri-tion age /+



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=

Cha-ter 2= Device Descri-tion age /1



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

Cha-ter 2= Device Descri-tion age /2



Cha-ter 2= Device Descri-tion age /!



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

Cha-ter != re-aring for ,our Device age //



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$.

Cha-ter != re-aring for ,our Device age /"



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

Cha-ter != re-aring for ,our Device age /&



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

Cha-ter != re-aring for ,our Device age /7



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

Cha-ter != re-aring for ,our Device age /



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$.

Cha-ter != re-aring for ,our Device age /:



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

Cha-ter /= Using ,our Device age "+



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.

Cha-ter /= Using ,our Device age "1



#. 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.




'. 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).

Cha-ter /= Using ,our Device age "!



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

Cha-ter /= Using ,our Device age "/



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

Cha-ter /= Using ,our Device age ""



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.

Cha-ter /= Using ,our Device age "&



<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




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.

Cha-ter /= Using ,our Device age "



<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.

Cha-ter /= Using ,our Device age ":



+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 /

Cha-ter /= Using ,our Device age &+



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.

Cha-ter /= Using ,our Device age &1



<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.




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

Cha-ter /= Using ,our Device age &!



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

Cha-ter /= Using ,our Device age &/



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.

Cha-ter /= Using ,our Device age &"



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 stores-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.

Cha-ter /= Using ,our Device age &&



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.




*$,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

Cha-ter /= Using ,our Device age &



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 &:



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+




$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.

Cha-ter "= <roubleshooting age 71




$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.





$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

Cha-ter "= <roubleshooting age 7!




$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.

Cha-ter "= <roubleshooting age 7/




$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"




$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.

Cha-ter "= <roubleshooting age 7&




$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.


003 patient manual redacted

Documents