Zeiss VISUPHOR 500 User manual

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VISUPHOR  500 
Digitalphoropter 
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Documentation set 

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©2022,CarlZeissMeditecAG,Jena 
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Allrightsreservedintheeventofgrantingofpatentsorregistrationasautility 
patent. 
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Allnamesofcompaniesandproductscitedinthisdocumentationsetmaybe 
trademar sorregisteredtrademar s.Thirdpartyproductsarecitedforinformation 
purposesonly.Thisdoesnotrepresentapprovalorrecommendationofthese 
products.CarlZeissMeditecAGacceptsnoliabilityfortheperformanceoruseof 
suchproducts. 
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Bluetooth®isaregisteredtrademar ofBluetoothSIG,Inc. 
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Otherbrandnames,softwareandhardwarenamesusedinthisdocumentationset 
aregenerallysubjecttotrademar orpatentprotection.Thequotingofproductsis 
forinformationalpurposesonlyanddoesnotrepresentatrademar misuse. 
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Theweblin saredynamichyperlin s.Beforeincorporatinganylin s, 
CarlZeissMeditecAGchec stheircontenttoensurethatitisnotli elytoresultin 
civilorcriminalliability.Itdoesnot,however,continuouslychec foranychanges 
whichcouldformthebasisforliability.IfCarlZeissMeditecAGdeterminesthata 
lin whichithasincorporatedcouldresultincivilorcriminalliability,orisalertedto 
thefactbyathirdparty,thelin willberemoved. 
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Thisdocumentationsetisprotectedbycopyright.Unlessexpresslyauthorizedin 
writing,dissemination,duplicationorothercommercialexploitationofthis 
documentorcommunicationofitscontentsorpartsofitisnotpermitted.Violations 
mayresultinpaymentofdamages. 
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Specificationsduetotechnicaldevelopmentsaresubjecttochange.This 
documentationsetisnotsubjecttotherevisionservice.Pleasecontactthe 
manufacturerorauthorizeddealertorequestthelatesteditionofthe 
documentationset.

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Contents 
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User manual 
VISUPHOR 500 
Digital Phoropter 
[000000-2075-933-GA-en- 
GB-230822] 
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000000-2075-933-Inhalt0-en-GB-230822 

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VISUPHOR  500 
Digitalphoropter 
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User manual

Notice
FCC Statement

 !
!
!"
!#

$
% !
% #&!
% '!
% ()*!
FCC Caution:
+(
,!
 !-.$
/0 
/10 !
IMPORTANT NOTE: 
FCC Radiation Exposure Statement: 
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This equipment should be installed and operated with minimum distance 20 cm between the radiator and
your body.
This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

IC Statement
#243556!
7 89:3556!
#3( 44/0!-.
$/0/10
!
;7(9 <#((!
;<(7(($/0</10
<<7=
<!
   /           ##0  
#(
!+(
!
    /0    3    .     
!
              
!9 
!
IMPORTANT NOTE:
IC Radiation Exposure Statement:
# 44351(!
15>! 
7(# 44351<((7
?7!
000000-2075-933-GA-en-GB-230822

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Contents  1 
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Contents 
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Contents ....................................................................................  1 
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Notes on the user manual .........................................................  3 
Purpose an availability of the ocumentation ..............................................  3 
Questions an comments ..............................................................................  3 
Explanation of symbols use ..........................................................................  4 
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Package check list.....................................................................  5 
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Country-specific information an labels ...................................  7 
Classification/Manufacturer's eclaration ......................................................  7 
Inten e use ...................................................................................................  8 
Patient population ..........................................................................................  8 
Si e effects/contrain ications ........................................................................  8 
Inten e user profile.....................................................................................  8 
Notification to manufacturers an authorities ...............................................  9 
Disposal of the pro uct ..................................................................................  9 
External labels ..............................................................................................  10 
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Performance specifications .....................................................  16 
Functional escription .................................................................................  16 
Characteristics ..............................................................................................  17 
Service life....................................................................................................  17 
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Description of the evice ........................................................  18 
Phoropter hea .............................................................................................  18 
Junction box .................................................................................................  19 
Near-point chart ..........................................................................................  20 
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Installation ..............................................................................  21 
Notes on installation an use .......................................................................  21 
Unpacking an installing the evice .............................................................  22 
Interfaces to mount the phoropter hea ......................................................  23 
Interfaces to connect external evices .........................................................  31 
Interface to VISUSCREEN control unit ..........................................................  31 
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Daily startup ...........................................................................  33 
Switching on .................................................................................................  34 
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000000-2075-933-GA-en-GB-230822

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2  Contents 
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Operation of the evice ...........................................................  35 
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Shutting own .........................................................................  42 
Switching off the evice ..............................................................................  42 
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Maintenance an care .............................................................  43 
Troubleshooting ...........................................................................................  43 
Replacing the forehea rest .........................................................................  44 
Replacing the face rest ................................................................................  46 
Replacing the fuses ......................................................................................  47 
Maintenance ...............................................................................................  48 
Careandcleaning...............................................................................................  48 
Cleaningtheexteriorcomponents.......................................................................  49 
Safety inspections ........................................................................................  50 
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Replacement of components ...................................................  51 
Replacing the phoropter hea ....................................................................  52 
Disassembly........................................................................................................  52 
Mounting............................................................................................................  53 
Replacing the junction box .........................................................................  54 
Disassembly........................................................................................................  54 
Mounting............................................................................................................  54 
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Optional accessories ................................................................  55 
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Technical ata.........................................................................  56 
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Electromagnetic compatibility .................................................  58 
Ambient con itions for inten e use ..........................................................  58 
Limitations on essential performance features ............................................  58 
Emission .......................................................................................................  60 
Immunity ......................................................................................................  61 
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Abbreviations/Glossary ............................................................  63 
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Figures .....................................................................................  64 
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In ex ........................................................................................  65 
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000000-2075-933-GA-en-GB-230822 

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Notesontheusermanual 
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Notesontheusermanual 
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Purpose an availability of the ocumentation 

Thisusermanualdescribesthesafetyprecautions,functions,usage, 
performanceparametersandcareandmaintenancemeasuresofthe 
VISUPHOR 500DigitalPhoropter. 
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Correctoperationofthesystemisimperativeforitssafeandsuccessful 
function.Youshouldthereforeensurethatyouarethoroughlyfamiliarwith 
thisusermanualbeforesettingupandusingthe VISUPHOR 500thefirst 
time. 
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Theusermanualsandotherdocumentationenclosedwiththe 
VISUPHOR 500shouldbeeptaccessibletousersatalltimestoensurethat 
theinformationrequiredforuseofthe VISUPHOR 500isreadilyavailable. 
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Questions an comments 
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Ifyouhaveanyquestionsorcommentsconcerningthisusermanualorthe 
VISUPHOR 500,pleasecontact ZEISS serviceoryourlocaldealer.(Contact 
detailsseereverse). 
3 
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000000-2075-933-GA-en-GB-230822 

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4  Notesontheusermanual 
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Explanation of symbols use 
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Thesymbolsusedinthisusermanualrefertoimportantsafetyinformation 
whichmaywarnagainstpossiblehealthris sorfatalinjuriesandcontain 
usefulnotes.Wheneveryouseethesesymbols,readtheaccompanying 
informationcarefullyandobserveallsafetynotesandinformationinthis 
usermanualandondevicelabels. 
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WARNING 
Indicatesahazardoussituationwhichcouldresultindeathorserious 
bodilyinjuryiftheappropriatesafetyprecautionsarenotheeded. 
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CAUTION 
Indicatesahazardoussituationwhichcouldresultinminorormoderate 
injuryiftheappropriatesafetyprecautionsarenotheeded. 
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CAUTION - PROPERTY DAMAGE 
Indicatespossibledevicedamageiftheappropriatesafetyprecautionsare 
notheeded. 

 
Information,hintsandadviceforbetterunderstandingofthe 
instructionstobeobservedintheoperationofthedevice. 
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000000-2075-933-GA-en-GB-230822 

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Pac agechec list 
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Packagechecklist 
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Thepac ageincludesthebasicdevicecomprisingthephoropterheadandjunctionboxandalsothe 
partsshownbelow. 
5 
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1  Phoropterheadconnectingcable 
2  Fasteningscrewswithscrewcoversforcoveringtheconnectorcompartment(Fig.27) 
3  Fixingrodfornear-pointchart(length70cm) 
4  Near-pointchart 
5  Powercableforjunctionbox 
6  Bluetooth®/USBadapter 
7  Foreheadrest(replacementpart) 
8  Facerests(replacementpart) 
9  Fuses(replacementpart) 
10  Dustcover 
11  Documentationset 

Fig.1  Pac agechec list(withoutassemblyadapter) 
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000000-2075-933-GA-en-GB-230822 


6  Pac agechec list 

A apter for mounting the A apter for mounting the A apter for mounting in axial 
evice to the bottom part evice to the front part of a irection of a support arm 
of a support arm support arm 







ZDR10includingmountingset 
(4AllenscrewsM4x12mm 
and4xcorrespondingE-rings 
D7.4mm) 
ZDR18with3spacers  ZDR19 
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ZDR14  ZDR20(optional) 
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ZDR15 
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ZDR16 



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Mountingset1: 
4AllenscrewsM3x10mm, 
4correspon ingE-rings D 5.4 
mm 




ZDR17 
Mountingset2:

4AllenscrewsM4x10mm, 
4correspon ingE-rings D 7.4 
mm 





Fig.2  Pac agechec listofassemblyadaptersandcorrespondingmountingsets 





000000-2075-933-GA-en-GB-230822 
Mountingset3: 
AllenscrewM5x15inclu ing 
washer D 9.8mm(fixe to ZDR 
19) 
Phillipsscrew0.25”x16mm 


Country-specificinformationandlabels 



Country-speci icin ormationandlabels 

Classification/Manufacturer's eclaration 


WARNING - GENERAL HAZARD 
Thisdevicemaybesetup,operatedandusedonlyfortheintendeduse 
andinaccordancewithlocalcountry-specificregulations,generally 
acceptedengineeringstandardsandoccupationalsafetyandaccident 
preventionregulations.Furthernotesonclassificationaretobefoundin 
Section Technical data,page56andfollowing. 


EMC:  SeeSection Electromagnetic compatibility, 
page58andfollowing. 

HF transmitter:  SeeSection Technical data/ HF transmitter 
specifications,page57. 

UMDNSNo.:  13-313 

Thisdeclarationshallberenderedinvalidifchangesaremadetotheproduct 
withoutthemanufacturer'sauthorization. 

Thejunctionboxfor VISUPHOR 500correspondstotherelevant 
requirementsinthe EU Directiveonradioinstallationsand 
telecommunicationequipment.Thecorrespondingdeclarationofconformity 
canbeobtainedinEnglishfromCarlZeissMeditecAG(contactdetailson 
reverse). 
7 
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000000-2075-933-GA-en-GB-230822 


8  Country-specificinformationandlabels 



Inten e use 

VISUPHOR 500DigitalPhoropterisusedtoidentifyrefractivevaluesbased 
onfeedbac fromthepatientbeingexamined(subjectiverefraction).The 
deviceisusedtosupporteyecare/ophthalmologyspecialists 
(ophthalmologists,optometristsandopticians)whenprescribingcorrective 
eyeglassesandcontactlenses. 
VISUPHOR 500DigitalPhoropterisacomputer-controlledunitforthe 
subjectiverefractionofpatients.Inadditiontoidentifyingtherefractive 
values,theunitisalsousedtodetectanomaliesinthepatient’sbinocular 
vision,suchasmusclebalance,binocularbalance,anisoconia,fusion, 
stereopsisetc. 

Patient population 

Thedevicewasdevelopedforawidepatientpopulation. 
Inprinciple,peopleofallagegroupscanbeexaminedinaccordancewith 
thesideeffectsandcontraindications. 


Si e effects/contrain ications 

VISUPHOR 500DigitalPhoroptershoul notbeuse for: 

• 
Patientswhocannotprovideanyusablefeedbac (infants,mentally

retardedpersons,...). 

• 
Patientswhoarenotabletobringthemselvesintopositioninfrontofthe

deviceasaresultoftheirphysicalcondition(e.g.,duetotheirphysical 
size,posturaldefects,...)ortoeepstill(e.g.,duetoPar inson’sdisease). 

• 
Patientswhocouldbeinjuredbyusingthedevice(e.g.,injuriestotheir

foreheadorface). 

• 
Patientswithinfectiouseyediseases.


• 
Patientswhoworecontactlensesdirectlypriortoexamination.



Inten e user profile 

CAUTION - RISK ARISING FROM OPERATING ERRORS 
Thisevicemayonlybeinstalle ,operate ,use an maintaine by 
personswhohavebeenproperlytraine orwhohavetherequire 
knowle gean experiencetooso.Pleasealsoa heretothenational 
qualificationgui elinesapplicableinyourcountry. 






000000-2075-933-GA-en-GB-230822 


Country-specificinformationandlabels 



Notification to manufacturers an authorities 

InmemberstatesoftheEuropeanUnion,theresponsibleorganizationor 
personmustreportseriousincidentstohiscompetentauthority.Inallother 
countries,comparablerulesapplywherenationallegislationsorequires. 


Disposal of the pro uct 
9 

 
Thepac ingmaterialshouldbeepttobeusedforafuturemove 
orforrepairs. 

Ifyouwanttodisposeofthepac ingmaterial,pleaseusea 
recognizedcollectionsystemforrecycling. 
Thesystemcontainselectroniccomponents.Attheendofthe 
servicelife,thedeviceandthebatteriesinstalledinithavetobe 
disposedofproperlyaccordingtothenationallaws. 



Disposal of the evice within the EU 
Inaccordancewithapplicable EU guidelinesandnationalregulationsatthe 
timeatwhichtheproductwasbroughtontothemar et,theproduct 
specifiedontheconsignmentnoteisnottobedisposedofviathedomestic 
wastedisposalsystemorcommunalwastedisposalfacilities. 

Fordetailedinformationonthedisposaloftheproduct,pleasecontactyour 
localdealerorthedevicemanufactureroritslegalsuccessorcompany. 
PleasereadlatestInternetinformationprovidedbythemanufacturer. 

Wheretheproductoritscomponentsareresold,thesellermustinformthe 
buyerthattheproductmustbedisposedofinaccordancewiththecurrently 
applicablenationalregulations. 
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000000-2075-933-GA-en-GB-230822 


10  Country-specificinformationandlabels 



External labels 
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3 
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10 
14 
12 
6 
7 
8 

5 
4 
1 
11 

9
 13 


Fig.3  Warningan informationlabelsonthe VISUPHOR 500 
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000000-2075-933-GA-en-GB-230822 


Country-specificinformationandlabels 



Item  Label  Explanation 

1  Typelabel 
Manufacturer 

Dateofmanufacture 

Appliedparttype B 

DCvoltage 

2  Identificationlabel 
REF  Cataloguenumber/partnumber 
SN  Serialnumber 
Bottom:  Serialnumberasbarcode 

3
 Deviceidentificationcode 
(datamatrix,serialnumber,anddevicename) 
11 






4  Notapplicable  Notapplicable 

5  "Observeusermanual"informationlabel 



6  CE approvallabelanddisposaladvicefor EU 
EU conformitysymbolwith 
identificationnumberofnotifiedbody 
Disposaladvicefor EU 


7  ULapprovalforUSAandCanada 






8  Warninglabel 
Useoftheapprovedjunctionbox 







000000-2075-933-GA-en-GB-230822 



12  Country-specificinformationandlabels 

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000000-2075-933-GA-en-GB-230822 
Item  Label  Explanation 
9  
Countryoforiginlabel 
10 
Notapplicable  Notapplicable 
11  Notapplicable  Notapplicable 

12 

Labelformar ingthedeviceasamedicaldevice 
13  Notapplicable  Notapplicable 
14  Notapplicable  Notapplicable 


Country-specificinformationandlabels  13 

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6 
9 
10 
3 
1 
5 
2 
8 
4  7  11  12 


Fig.4  Warningan informationlabelsonthejunctionbox 


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
000000-2075-933-GA-en-GB-230822 


14  Country-specificinformationandlabels 



Item  Label  Explanation 

1  Typelabel 
Manufacturer 

Dateofmanufacture 

Appliedparttype B 

ACvoltage 

DCvoltage 

2  Identificationlabel 
REF  Cataloguenumber/partnumber 
SN  Serialnumber 
Bottom:Serialnumberasbarcode 
3 
Notapplicable
 Notapplicable 

4  "Observeusermanual"informationlabel 



5  CE mar inglabelanddisposaladvicefor EU 
EU conformitysymbolwith 
identificationnumberofnotified 
body 
Disposaladvicefor EU 


6  LabelwiththeMACaddressofthe 
Bluetoothmoduleandtheregistration 
numbersfortheUSA,CanadaandJapan 




7  "Disconnectdevicefromthepowersupply 
beforeopening"informationlabel 


8  Countryoforiginlabel 

9  HF transmitter 
(seeSection Electromagnetic 
compatibility/page58) 





000000-2075-933-GA-en-GB-230822