ra9

itrHRtrMAIT

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('i:-;,7
Document No. : OPM-IR2-EN
oale:2015 12.20 {R*05) hc;tah
Th. inlormarion cohrai^ed h.r€in is suble.t to.hang€ wiiholt prior noti.€.
Bodir€ch Med I.c shallnot be lable ror anyr{hni..land edito at.rc6 orohisiotu contain.d

Addilion.ly,3ny maltundion n.lements induling rhe optrc.ls.nsor ass.mbv the rFtem bo.d .nd
the drive ta r sholld be consulied with and serui.ed by Bodte(h Med Inc. Any unaurhoriz.d operationt
on elements not sugqened ln rh6 doomenl willvo d the *sung w.naniy

lat tthhi.al aeistance co,tact

B.dat..h M.d ln..! T.ch.iol S.rvi(.3
Tel +82l3 241 1!00, E-mail suppon@boditech.co.kr

{ roa,..n r"a
".o,ooor"r
41, Geodudanli 1-qil, Donqna.-myeo.,

Chuncheon-ri, Ganq-*of -do, 24398, Republ( oi (orea

IeI +32 33 2431400/ Far:+82 312419371

r;T;] ., .

Bd GEiaGlwahk s3, 1030 8tu$elr BELGIUM

Te[ +(32) 27325954

E-Marl r mail@ob.lishet

D.r. ot l.rt Evi3id : D.emh.r 20, 2016

ft
Th. .cturl .oni.nt of th€ dhpl.y eul.l difi.r. dcp.nding on rh. sp..itr.ation ..d .unom.r

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Date r 2016.12 20 lRe05) hdifth
Tabte .ontenrs

11.6. ichEmaB lt DC Cdn*tor C.bt. (USB 016 Cabt.)...,,,......_..._........,..................... ,.. ................ ..50

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2 2 NlB 2015 El-,,,Llrc;,;T
 No.
Document OPMIR2-EN
Date 2015 1? 20 (R40t) hritrh
1. lntended Use
ichfomatu tr is a semi'auto portable fluofescence scanning instrument for
measuring the concentration of deslgnated analytes in the human blood, udne and
other specimensj duly prccess€d and tested in accordance with various ichroma&
Immunoassay Tests manufactured by Boditech lved Incorpo6ted.
ichrornatu tr is to be used only in conlunction with various ichromaD lmmunoassay
Tests and meant only for in vivo diagnostic pr,.pose.
ichromatu tr
can be used fo, scrcening, rnonitoring and/or routin€ physical
examination in centralized laboEto es of hospitak, physicians clinics

2. Introduction
ichromatu tr is a semi-auto portab:€ fluores(ence scanning innrument for
measuring the concentralio. of designated analytes in th€ hum.n blood, !rine and
other specimens; duly processed and rested in ac.ordan(e with va ous i.hroman
tmmunoassay Tests manlfactured by Bodit€ch Med IncoQorated. ichrcmar tr is
e:sy to us€. When colle.ted samples arc loaded to a test cartidge, ichroma,! tr
fteasurcs intensity of fluorescent signal ichroma" tr conve(s this tntensity of
fluores.ent signal to quantitative value and displays this value as a test resulr.

3. Safe9 Information
. Safety intormation pior to u*
1) Please read this manual before use
2) This equipment is in vitrc diagrostic medical device. Please ure it with conect

3) ichromafr E is only compatible with ichroma^ test ca(ridges manufacnrrcd by

Boditech Med lnc. In case of use of other test cart dges, it mry cause
malfunction of ichroma" tr or incorect iest results.
4) When inltial pu(hase and installation, please set eracvcorrect dare and tim€.
Incorcct seiling may cause va ous €rols regarding expir.tion dare.
5) To pevent infedion or contamination, pl€ase use prcte<tiw glo!€s, mask and so
on durinq handlinq test samples.
6) All tests should be done at flat and srable place. Do nor move and force
mechanical stress in ichrcmatu tr d!ring resrs
7) rcr.orra" Il-ould be i. (lean pl.c€.
"sed
8) Please use ich.omaB tr indoor only.
9) Operation tempeGture is t5-35r {59 - 9S'F) and humidity is maximum 7O%. r
ichroma" E is stored at some place whh out of opeGrion environment, ptease

luper-oo roB r 6rox,u66ifi

2 ? tilll 2015
Doom€nl No : OPMiR2-EN
Dal€:2016.12.20 (Rd05) hdrfth
leave it operation environment at teast 30 minutes.
10)If the .artidge holder or holder cover arc contaminated by some reagen! dust
or foreign materiak, please cleas them and l]se i.hroma* E.
l1)Extemal st€sses such as mechanicat, chemicat and €tectri( srresses can cause
maltunction of ichroma* II or incorrect tert resutrs. Do nor (ress ichromar tr

. Warnings and @utiont

1) ichrcman tr is only for in vitro diagnostic use with ichroma* test cartridges.
2) In case of flning maltunctions in tchrcmah tr, tum the power off immediat€ty
and co.tact regional distributor or Bodnech Med tn.3 techntcat suppon.
3) Install ichrcma," E at flat su{ace.
4) Excesslve force during inrerting a iest
cartidge inro the cartidge hotdei switches
or buttons may cause malfunction o. eror in ichroma- tr.
5) B€ caretul i. handling test smples to prevenr infection.
5) Do not innall ichromatu E at high temperature and humidity ptace.
A Avoid exposure of ichromat tr ro dlst satinity, warer or any orher liquid and
direct sunlight.
8) Please use your ichroma" tr gentl)r Avoid throwing, shaking, or dropping it,
which may damage ,ts ,nre,nal compone.ts.
9) Do nor store E in chem,cats srorage o, gassing arca
'(hroma"
10) Remove power cable tr is not used ,or a tong time.
if ichrcmar
11) Oo not allow ichromar tr to come in contact with liquid in a.y manner.
12) Do not pla(e anlhing on top of ichrcman II even when it is lyinq tdte
13) Read this manual carefully before use. Viotation of instruction for insta ing and
operat ng i<h.omatu U may cause electric, mechanicat or bio-hazardous isk
14) We do not r€sponsible for any unauthorized op€ning or seruicing of ichromatu
II. When )ou find malfunctions in ichroma- tr. ptease conta.t regionat
distributor or Boditech M€d Inc3 rechnicalsuppo ream.
15)The user of i.hroma* E in conjunction wjth the ichroman tesr shoutd not arrive
at any conclusion .ndlor should not tak€ any decision of medicat/therapeutic
importance afterknowing the test resukwitholt firstconsuking his/her physician.
16)ichromar tr rhould b€ operared by vained medicat t€chnotogist or medi.at
personnel such as nurse or physicians.
14lf you have any inquiry regading ichroma" E operation, please contact regionat
dist butor or Eoditech Med ln* technical support team.

2 2 N)B
Arpertop rOS;;;;6;;;
2018

'F, OXl orirlrA

Document No : OPM-IR2-EN
Date r 2015 12 20 (Rw.05) hdifth
Storrg. .ft.r using & managem€nt
1) Please insed crn dge holder by tapping 'inlout" button after using ichrcma
tr to prevent contamination by dun or loreiqn mate als.
2) Whenyou turn the pow€r off pl€ase follow propersteps des.ribed in rhis manuat.
If not, it may cause malfunction in ichroma" E.
3) Do not open or aher ichromaD II by intention.
4) storc ichroma' tr at liquid nee place.
5) Store ichroma tr at slope/vibhtion/mechanical shock free place.
6) Do nol store i(hroma- tr in chemicah storage or gassing area
a Arcid direct sunlight du ng storage.
8) In case ofichroman tr exterior k contaminat€d byfo.eign mat€riak, ptease wipe
them out using soft and dry cloth or tissu€.

VaroLrs symbols are !sed in th s manual as follow

Consult rnstruct ons fo/ use

lar k vttto diagnostic lse

This p.oduct fulfilts the reaunements of Dnedive 98r9^C on In Vitro
Oiagnonic Medical Odices

Read nsl/urtons before use

Separate colleclion for electri.a and eledroni. equipment

L]SB

t
LASER Radiation Do not nare nto beam

Ihis symbol is esentially a safely slmbot and should b€ used to

highlighl the fact that the.e are specific wamings or precautions with
the dwice which are not otheMise found on rhe label. The swbd

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2 2 il{08 2010
6]OXLNIOAPMA"

kx""''%
Oo.umenr N. oPMJRT-FN
Date 2016. 12 20 1Rd.05)
"Caution" is srillsom€times used ro have rhe meaning of;enention,
Mifth
Iodicates a hazardoLrs sil!ation whi.h if not
injury lo the operator or a blslander (eg etecrncat shock or UV

4. Prin.iple
chom." E it a iuor€s.€nce s..nning iGrtume.t to be us.d in .o.junction qith E ous i.h@ma,"
Imnunoassay Tesis whl.h aEbased on.nt q.n,.^tibody Eacrior ahd fiuor*ce nc. techno to gy i.h@ma- II
user. semi.ond!.tor d iod e l.ser as the excil.tion tight sourc. ror iluminatinq th€ ten crrtidge membran€
Ipreload€d wiih th€ .linl.al sp..im.n dut proc.ssed as per the si.nd.rd t.sl proc€dure pGsc b.d by
Sodiiech Med lnc) th.reby r ggering fluoescenc. nom ihe fiuorochrcme motecutes preseni on lhe
nembran. Th. ,luores.e.r ligtn k cotteded together with lhe sc.ttered tas€r tiqht. plre fuor6c.... is
lih€cd lrom the minurc ol the scaneren and n!or6(ed tight.lntensity ot th€ fllor.5cne G scan^ed and
conw.ted inio .n .l€ct.lc sign.l wh d ir proponionat to rhe intensity ot fluores.ence podlced on rh€ r€sl

micropoc.se. compotes conce.rrat on ofrh€.n5lyr€ in the ctiaicatsp*imen based on a pre

The on-b@.d
pbgEmm.d calibration Th. compui.d and.onverred €sult i5 dijptayed of rh€ dispt.y scGe. ot the ich@ma
"E,

5. Paakage Gontents
l.homat E and it! ac.€ssones are p@vided in a singt€ box For prcper oper.tioo of th€ srlieh, u5e. mlst
befamili.rwilh the te.hnicalterm and use ol.ach irem User musl enslrelhat tolowing item! are inctuded
the.ommerci.l p.ckag€.It.r'y h.mG) were io b. nkinq, pt.as. conta.t your sat.s distnblt.r or Boditech
Med Inc! ostomer c.r. rcpresentarirc(r€t* to Secrion 14. Wananty)

i, ac adipror & powsr..ble

@ System (he.k (a4.idg. s.r

',

2 2 ll0| F,1(;,( I t.r1r,A P l\i A

101fl
Dodmenl No. :OPM-IR2-EN
oale : 2015. 12. 20 (Rry.05) hcirsh

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2 2 lrlud 2018
S tox r r\40A Ptll A,
ooom€nr No : OPMIR2-EN
Dai. 2016 12.20 (RerO5) hrdrh
6. Technical specif ications

Fluores.ent Immunoa*ay

276mm (w) X 22omm (L) X 91mm (N)

Input 1@-2ilOV - 5Ol50H2 13A

Slepper Linea. Aduato6(5V O34AJ

us3 4 porls LAN Porr, US3 0T6 pori

Hlmidity 10-70% (Non-conde$in9)

Humidny < 90% (Non-(ond€6inq)

P.lient t.n 1 000 r.ruh!

Syslem che.k ten reeuhs: 500 Esutts
Controlfr.te als ren r.suhs:1.000 resuhr

SavinglD (hip nfomat on 5001O chipt (maximum 5 LOIS per item)

ichMa" I] mcetr th. EMC guirtcline d p€r EN 61326,2-6

2 2 lr(08 2018
DocUme.I N6 : OPM-IR2.EN
Dde: 2016 12 20 {Rd.05) fodrteh
7. Funational and operational elements

Front side view of ichroma" tr

You.an inpulvarious need.d in,ohatio. lor tBti.g I,y rouchpad ol

o --O LCD d sohr6 vaiou! irponant
'.,omaron
i!(h as a.@s
natus r.n $ 6i
'.!uh<:nd
to

lnseningrest.a idge for proceeding resrs.

a) Holdercore.k 6rlighl /dun /lorciqn mat€.iak prs^tion

o) It measurcs oohtempeElurc arcund ichroma" tr.

rT:'1 l.d infom.tion rcgarding oprional items, ptdse coftcl @qionaldkhblro.

I lrl For deta
or Sodr(h Med In.3 l{hni.al qles leam.

A Temperaturc s€nsor measures

i artional heatingorcoolnq.
Do not insr.ll i.h@ma- u in.E:
@m t.mpebture Oo hot chanqe

whkh has big remp.ratuc v.nat on

lempebtur. by

Aupexrop TOB rBloxrMSapMa,

2 2 11{08 2018

'6tox l,rioAPlMA
oo.lme No oFMIR2-EN
Dar.:2016 12 20 (Req05) hdifth
Bottom and r.ar side view of i.hromat E

Il
-l
cl

:5
()
o
# aTl

When the banery cow i. op€n€d, you cn i.statt/set baft.riB and

@

@
o Connedion pon for AC adapi.r

o conn.dion Don to. Pc .onn..|on and conmuni.:ti.n

Conneclion pon lor bai.ode s.?nnei keyboard, WIFI Dongle,
Bluelooth Dongle and USB memory nEk

o Connedion pon for Etheher connection

2 2 2010 '610xif,roAPMA
'f0B
 No
Do.ument OPM-lR2-EN
Date 2016 12 20 (Rev05) hritth
8. Power supplement
Power6lihg lor i.homa" tr B A( 110-120V or 220-240V 50 - 60H.
To p.oba €led. hazard su.h at .leclric shock and fle please us. AC adapror and
l i\
,A pows cable providen by Boditeh Med Inc only and chak power rar ng belore use.
<onim power Eting, please conslh wrh your ladllty manaqement offic.r
lr you can't
Danger
when using bafteie' please ch(k the rype of bateries IAA ryp€) and indall rhem

. U!€ of AC ad.pio.
1) Please checllhe powq swnch is ofl'{O)'and conn€ct AC adapto. ro th€ pow€r pon.

2) conned power cord to .n.halpover olnet

Us. or bandies n ont aEihble in cas. oi . blackour lor nna operauon lt s

imposribl.lor nohalus€ with batte.6 ror a lo.g tihe W€ suggest ro usa AC adaplor
5nd powercable lor nabl. a^d sale opeEtion lt is possible l0 lllit€ns or 2 singte
tens wien baftd.s arc u..d
ll s po$lblelo useAC adaptor a^d banen.s simuhan.oudy
But we suqqd lo remow ba(er.s when AC adaDlo. is lsed
Pl€.se do not usa a p nlerqhen l.hrcm.- II ir operaling wirh bafieiei
Use ol a pnnler.a^ cuse power down due ro.x(essive powerconslmproh

c@r ir th€ bottom ot th€ th6mrE E.

1) Open lhe batiery Ple.se dred( lh. diredor ol6ane es and
inse rh.m with.or..r dic.rioh

t.:l
l'r-r !,-----"9

2) Closa rh. batt.n/ covs and pur rh. i.h@ha, tr on nghr postion

P,'pu'-op roe *s.i*Si

2 2 )r{08 201S '/ r o6raer.,or, \+

& n".",,r* '5IOX I,IOAPIJA

oo.umenl No oPM-IR2-EN
oare: 2016 12 20 (iey05)

9. Installation

R.Lr to Section I aad S€ction 3 pno.lo inrt.tt.tion.

l) connect . porer cod .hd ac ad.pto, p@id.d by sodn*h Med In.. to ih. pows port o, crr sid. of
'.h@man
IL Th.n lum th. p4r eritch on.

2) ichrcm.E IJ displays the p6du.r logo .hd toading screen sen.lt when t@ding, it t.kes few se.onds

It loadinq screen lasts more ihan 5 m nlr€r plers€ rlm ichomar E oft and lun it
on again.lrsrm. probl.m k oc.ured, pt€.s. .a ti Sod ilech M.d lnc! lechni.:tsetutce
or author zed r.qional dl{nbllor

l)Wh€n loading i5 completed, i.hroman tr witt prcce.d the self-i€n n9 and display rhe selilestinq rcruh5

Synem ol throms" E k

Iher€ are some pEblms in

th€ r.l€wnr pa.ts or

t mpehrlE ir out ot

2 2 2010
'fl08 6 iox lt\,10,4 F MA
oo.umehr No oPM-IR2-EN
Dare 2015 12 20 (Re05)

-tur. orl Iurn the dev.. off and

calllo manufactu€ or authoized.egiona

Ignore: You .an proc..d the next nep but ir is imposible lo i€n items

It , ,o$ible to len tems bur telt r.suhs may not be 3..u6re becalse
lemperaturc is our ol sugge(.d cohdilon. Pease call to manlfacruGr or
Tenpei;ture sensor Ercr au$oized regional disrributor
Turn olt Turn lh.devce ofland callto manufaciurer oraulhonzed rcqional

Ignor. You .ah pro(eed lhe neyt st p and l€n ir€ms.

It is po$ible to len ilem! but p nting lest BUlt out k impo5.lbt.. ptease
c.ll lo ma^ulactu.er or iutho zed.egion.l distiburo.
lumoll lurnlh.d*1..olf andcalltomanulactuero/.ulho led rcqionat

Igmr.: You can p.oc€ed the nd nep.nd t€st it.ms.

,/i\
/!\
Pesse set envronmentlenperalueas 15 - 15.(.
Tum o,lt Iurn the devic. ofi and wat lor eNionnsnt remp.Erure Eaches
to the opeGlion lemp.6rrr.
Isnor.: You .an po.eed rhe nen neD.nd test it.ms

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Doome No : oPMIR2-EN
oare 2016. 12 20 (Rd.Ot)

Seltlesling items are .t rollow.

1. Ddvinq pan.nd pinter (.tt n onethem.l p nter k adopied)

4. ropeEllre (enrrcnme remp.ratu.e)

Do nol d sa$emble the l.hroma" tr vhen som. eaou ..t€wnr to s€lf.tenino ir€ms

A
lf you ium the dryice oft during s.Fr.ning pc€s, il c calse m.liunction of the

If the t.si r6llts show "Not aEilabte, tor driving pan opri6 o. disk, crl io
manuia.turer or authonzed req on.l dist butor
I lemper.iure ]5 out o, r.ng. ol operation t.mp.raturc(t5 - 35t), pt€.se sel
envionh.nr r€mparatur€ as 15 - 3SrC

is.omplered su...$tult lhe ich.omat tr wttldkptayth. narn 3.ren

Ihe actual .ont.nts ol th. display .ould ditt r, depending on the sp€citi..uon and

lr! "

2 2 NlB 2018 '610x |\40A

Fi{.,1A
Oo.umenl No OPM-IR2 EN

Date:2015 12 20 (Rey05) hciteh

10. ichroma* II operation

singleren, MuhiIen, QC len, Rfliew rnd Serup menu 6 shoM in the maii scG.n as lollow.

. Fun.tion for..rh buion

lvlove ro Single Ien mode

Turn the devce off or restan

Inr.rt or 4ed the @ ridge hode.

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2 2 )t(08 20ts
'5roxlf.40APMA
oodme.r No I oPMIR2-EN
oale 2016 1? 20 (Rey05) Qdrfth
. 2) DB.riprion 6t.rrh i.on
Nov-O3-2O15 / 8:lO:45 am +

ttntE Displaying batrery status when the ich@ma- E k operaring

E Thk .o. will be displayed *he. AC adaetor is conneded

Green r E^vi rof, m€ nt t.mp eratu r€ s rn the hng. oI t5,35t

tsl Red : Environmenr t.mp€rarure

3Sra
ir @i otrhe r.ng. ol 15 -

E
It
Thi5 iconwillbe displayed when WIFI s connert€d.

tr Ihie i.on wlll be displayed whe. Bluetooth ir .onnected.

F] This icon will be dLplay€d wheh Eth.h.t k 6nn.cted.

a,pe-opTdE-iE[.-E i]i
2 2 lt{08 2018
noBapcrk-rF
"6toxn4eAPt\4A
 No
Dooment OPMIR2-EN
Date 2016 12 20 (Rryos) M rteh
10.2. System check

System check s pe omed io.onfm the ich/om." E rc*s prope y

1)Open rhe syn.m che.k @ftrldge pou.h which k pa.ked with rhe ichroha" tr rnd ch*k rhe.ontenrs as
lollow(syslem.h.d @nridge .nd s)5teF che.k ID chip)

r.|r a al ll

If lherc are forcign marenab o^ lhe rho..llulose m.mbrane ol a 3yn.m ch.ck

@nidqe, lhL uill .a!s. .ron.ds rtsl€6 check Esult.
Do not load anyr6t samples nro the sample wellola 3yncm.he.k cartndg€

Do noi rouch rhe nitocellulose membran. of a syst.m .he.k c..t dge by h.nd'
Do not dam.g.lhe nirroc.llulose mefrbEn. oia ststem <h€.t.anridq.

2)Iap the "QC lest'on lhe main (een

l)Thenthe ich@6a" E willej.cl the cadidge holder aulomari.allJ.

atJ
4)lnsert a stsl€m .heck 10 chip nto lhe lO ch p pon and rap rhe'Nen" button on rhe LCO
-7'

2 2 )l{08 2018 tl,pexrop rOg .Sror,MO;;;;

'6toxtN40APMA
Doom€ni No : OPMIR2,EN
oal.:2016 12.20 (Rd.05) hdrtQh
wrong di€ction or ercessir. force du ng iBe ng rO ch p wil .ause matrun.tions ot

You must insert synen de.t IO ch p ro proceed 3ynem .heck pro(ds Be .aGtul to*

llyou los.sytleE.h.cklD chip, call Boditech Med l.c3 Te.hnicatseruice orauthorizei

userlD dkplay€d in LcD means rhat the rel€vant user togs in th. ichrcmaE tr
11loq in rundion is not usen, ihe ichroma- E wil dispt.ys GerID as L,t

.he.l canridg. eith co@d dnedon and rap lhe "Sian. bulton.

\\
,n
XIil
5)The lch.oma^ E p. ohs synem.he.k proce$ and

There is no n*d ro mak€.ounter me6!e_

You can us€ rhe rynem nom.lly.

Check lnerc a.e foreign nal€rials or dahag.s in a

system canndge and try ag.in synem che.k

Therc arc sohe problems in

Call Bodil€ch M.d Inc3 Tech.i.al s.M(e or
5r5lem .h{k cartrdg€ or
altho zed Ggion.l Epres.ntrtive it nhe

22 2018
,
' st ox I il oA Pl!4A
'ltos
Doomet No : oPM-IR2.EN
Oate: 2016 12.20 {Rd.05) hdrfth
A
Thd. .re som€ pEblemr in
Ch.ck
sy51em
th.E arc loeign mat nals or dadas* in a
..nddg€ .nd lry agri^ system .h€ck

Call Sodte.h Med Inc3 Technicrl s.ryice or

rrstem .heck @nridge or
authonzed regional cpEs€nrati€ il s6e

Insed a sy{em che.k ..nridqe in rh. .art.idqe

A
It is imposible to identily a
Chak lheG arc lor.ign matarals or damaqes on
brrcode ola system canidqe and tryaqain rynem
a

bar code on a synem .he.k

(all 8odit..h Med In.:s Ie.hnical letu(e or
authonzed raqionrl repreenlaliw if sam.

A
Lor nunbeG oI a sysrem
Chkk and match Lot nlmbeu o, a sFreh check
.a ndge and syslem .he.k ID .hip and lry agan

Call Sodile.h Med Inds Ie.hnical setuice or

ch€ck cnridqe and sJ6lem
aulhonzed r.gional rcpeentatiw I sahe
check Ig (hip do nol march

Trvou Ld" pd rts. r.n $uh ou! oy rappig 'Pnnr' Dunon

3) Ple.se pa.k a synen check canrdg€ ind system .h.ck lD chip in rhe ortqinal pouch .nd seatit Th€n
norc it .l rcom tempehiure.

Somerm.s LOT number and erpraton date may not be disptayed a..ording ro LOT
number ol rystem .h..k .anndg.

A.peKrop TOB (6oxrv+apMa, :_o6u.+eru,r

2 2 )li0B 2018
"ar*uir'r',li}-
'5,ox,n,oorrol
Oo.um.nr No : OPMIR2-EN
o.t.I 2015. 12 20 {R4.05)

10.3. Sdup
Iap lhe'selup'button then therhe i.nDma- E wittdispt.y setup s.reen as rolou.
condilion k saved and not ch.nged lholgh pows it on

10.3.1.Uer IO

sellp lor usihg of login tuncllon regisnation ot user rq (hange of urer infom.tion and erc is.Eitabt. in

1) S€tiiI, togin lukrion Orir *tting is ohty.v.it.bt. wh.n .dhttr L togg.d in.)
O rap th€'Login oN/otF" blronro sel lhis tundton

EEllEEErtit!
wr6 yd rap rh€ .or burd,

whd you bp rh. "oK' buro^,

Log'n tundion tr nor d.rabl..

To ser loqin tunclion, lo9 in with admin a.c@n

(The i.hromaE tr is set w ih Login OFF' by def.uh etr. r.t€asing.)
<Hwro log in admin.ccouni >

1)T.p lhe "setup > User ID-

3) Tap lhe "select User'.nd inpul passwod. Oh. inniatpas.d is -@0O..)

4) Ttp lh.'OK'for log'n and the ichrcma- :I will dkptay.Add. and ,Login ON/O(.
bltton in the botiom of ecr€en.

2 2 tt}B 2018
*',31';";'i.
5O:,1,;.,;p.,^

-_- _.-,::..
Oodm.nt No. r OPMIR2-EN
Dare 2016.12. 20 (Rs05) hrifrh
2) Rrgirlrali ol n.w U4r ID (lhir 3.dn9 ie 6b e .hL sh.n ldnh B logs.d in.)
O T.D lhe hdd'butron.

O Input new user lq pasword and tap rhe "OK" button to.ompleie reqtsraton olnew user

Whe. 'Logi^" tuncrion s I E, the i.honar tr r€qui6 User ID and p.ssrd to tog
in. 3e caretulspilling ol us€rlD and pa$wod
UserID.nd pa$wod lhould be nore lhan 2.tu.act.n.

, Tap user ID wh.l you want lo.ha^ge pa$wod.

O Tap 'Chanqe Pa$word" button

!rpe(rop TOB (SroxrMQapMa,

2 2 )t{08 2018
'6loxflroAPMA'
Dotud.nl No.: OPMIR2-EN
Dar.:2016 t2 20 (Re05) non*n
@ Inputrh.cur€nlpEssrc.d new password and newpa$vod for.onl'rmatron io.hange parsword Then

You.an change urer w thou log.ui procedure fron rhe.uiienr lser

O Lp rhe operator whar you w..r io da.ae

@E

Tap 'seled User" buttor Then ichEmaq ! wittdBptay.User chanqe men!. pop-up window.

O Input password and tap "O<" blron ro chanoe ur.r

gupexrop roa s,oxru4friJ

"

2 2 )l{08 2018 "6t0xllroAnlvl\

Oocuhenl No. : OPiillR2-EN
Dare 2016.12. 20 (ReoS) hditeh
Ths tund o^ is lor deleiion the Eghrered u!.6

O Tap a user what you wani lo delele.

E--
@ Tap "Delete" bullon. Then l.h@frau t willdispay "O.l€te ujernenu" pop-up u ndow.Input pasword

tunction ir used, you (a. find 'Lolout buflon in lhe ght bottom ol mrin menu

@ Ifyd wa ro logoul,lap'Logole a^d "OK" button by ruhs. Then ichona" E will disptay "Logrn
menu'pop-up windoe for new use.

4upexrop ros .-roxrigiiii

2 2 )1108 2018

5I OX iT,4 OA P]VA'

3r-,;;
ooomeni No. : OPM-IR2,EN
oale:2016 12.20 (Rd.05) hd;fth
10.3.2.IIEM Info,mtion
saup > IrEM lnfohaion
Ths t ror rcg siration and mamgemenl otIO chp intohation fo. each r( ilem.

Inra lo chip what you wanr lo regkter .nd rap "Load" burton. rhen i.h6nan E will dkplry lhe name ol
ID chipwhich G lnsgred inro theID chip por

o Toch<l rh€ rcginralion dite, LoI humber .nd €xpnatior d.le of the r.l.vanr item, taD lhe nrme ol
lem whar yo! wanr ro .he.k

E-
@ Io delel€ rhe rcginere! LOI s€l€rt the LOT ehli you wa lo det€t. and tap "Oetae. button. Then
ichroha" E will displ.y 'D€lele sel€ct.d it.ms?" pop-up findow To .onfirfi lhe d€tetion, tap 'yes-

rhb ftthc d will b. p6ant.d i" N. tututu

Mathum 5 LOTS olID (hip liem.an be saved
per ea.h
ln .ase of 5 LOTS ars regisle.ed, f user rry to cqiste. a new LOT on sam. iten, fte
oldest LOT will b. deleted :utomari.aly and a n4 LOT witt be egislered.
rhe saDe LOI on same tem,lhe larest lnfo.hation wrtLbe reg nered

(5rorM+rpM;

2 2 fi08 2018 "EIOX l\rloAFlVA

Dodmsl No : OPMIR2-EN

Dal€ : 2015. 12. 20 (Rd05) hddfrh

On.e an it.m G rcqinered, there is no ne.d 1o iBen IO chplhenyou t n rh. $me

It you pro...n t.d wnhod .egisration ol it€fr, ihat item will b. regist.red

There can be some llmitalion.c.odinq to LOT humber oi i.hrom." ftam.

10.3.3.Date & Time

Th6lundion s for sellinq date and tim.

You.an sel date byrapping "+" or 1" butt.n To fn sh sett n9 dale, tap -Set" button

You c.n sdtih€ bytappinq "+" or a'bunon To finish set nS tim., tap'Sel'bunoh.

You .an select 3 kinds of dare fohat.

!r.pel(Top TOB (6loxrMSapMa,

2 2 }li0B 2018
ffi r"".0,r*r
^
' 5rox lt\,leAPMA'
Dotum€nr No oPMJRT-FN
Dat€:2015 12 20 (Rw.05)

pl.ase ret lhe con.d and €x.d daie and im..

If incorect &te ir set, ichroma" E .ant c6tcutr. o.che.k.n erpnation date of t6l

10.tJ. Commsniotid

ThB E ior (onnea PC, Ern.m( wlFt.nd Btudoolh tundDn

Tap tunctioh uh.i you w.ft ro.onn.<t.

Ltrri!_rll ntt

Conn€.| PC wilh ichoma" II u.inq USB OTG cabte and raD 'ON- bl.tron

,vttl, 3tu.to9,rk Eth.rEt funrt@N *itt b" DreNad i, Nr hnuru.

USB OTG cable WFI dongle and Bluetoolh dongle aE optiond nems.
Ilconn€.lion s nor possible, pl.as€.ontacr authorz.d rcgion. dislibltoror Bodil€ch
Med hc! ie.hni6l setui.e

.';;,ili!,; i,
'
,..,,, , ,";";:i.
2 2 2010
6tC,,4.ooorO.
't{08
Documenl No : OPMIR?-EN
oar. 2016 12.20 (Rd05) hcifth
10.3.5.4b@t i.hroma* tr
Setlp > Abour .hroma" E

In this men!, you cah.h.* I rear. va6ion, memory, IP .d d.esr .nd s€lrtening..suhs ol ich@m.r tr, tn

b]
"Inilialze" bufton.nd tap -Ye{ butlon to p6...d lacrory sefi nq

When you run hctorys.tting, allsaved data eittbe delet€d and deteted dala.:n,t be
estor€d. Be.arctuLfor tunning ladory setting

S.lltesting resuh whch is disphyed n rhis menu is th. tatst rBt Esutt.
Temper:ture in the selheninq result u curEnt t.mD.ratuE.

lound,language p ni.rand update

I$
s.lup'sysiem>Display
1) Bnqlfine$: ichromat tr prcvides 5 ftps ol bdqhrnes

n,pu*rop rOA;E-,;;;;;
2 2 )tr0B 2018 '6 tox |\4 CA lMA '
Docume.t No OPM-IR2-EN
Dar.:2016 12 20 (R.{05) hdrreh
2) Sleep mode You selen lor $ing sa neep mode by iappry "ON'or "OFF' button. When y@ u* ste.p

Tme lor sl*p mode is lo 20, 30,60 and t2o minut€.

S.t!p>Synem>Sound
r) abm onlofi: You .a. sel ahm

ffi 9

ich@ha" E sounds alam when ten is compl.t.d, tim€r is Mr.nd ercr is occurud

Setup>syn€m>P.inter
1) ON: Wh€n pnfter is on, i.hroman tr wiltp.ints oll rhe test r6uh wh.nten k comptete!.
2) OFt Wheh pnder k ofi i.hroma" E do6 not pinl out the rd r.sutt !i.n rast is comptA€d. you .an
pdnt oul rhe pr*ious ten r6uh lor Muititen or Singteresr

ahpe*'op roe -E6;;6 ;

2 2 )t{08 2018
"6lOXltu1,t API'i A
D@m.nl No. : OPMJR2-EN
Oate:2016. 12 20 (R 05) hdifth
Setup>slstem>Lanquaqe
To.hanq. language lap l.nguage whai you want ro .ha^ge and tap 1es' buton Il yo! t.p -No' button,
language will not be chrnged

Suppo(ed languaoe wllbe changed accodinq to diom.,! equest5.

Serup>Syslem>Updaie
tunctioh for application and flW.E
Do nor rurn ichroma" tr ofi durinq updalihg.
Do nor d sconnecl (onne.ron.abre bebeen i.hrcma- n and PC dunng updating.
Upd.tinA proces willtake r.e seconds or few minutes.

Selup > Sysr.m > Upd.t. Applcition

'
O Open the ban.ry cov€r in rh. bottom ofichronat II
la Ins€fl a SD cad whlch lnclldes u inq nlormaton inlo lheSD @rd sloi as lollowinq pidur..

nupexrop roa *sroxiu6iffi r^orue

ie!c\,
,',,"";;:;:],'
22 2018
't{00 c&o""*,r,, b I(] \ tit4oA p/\,,lA
Oodm€nl No.: OPMIR2-EN
Dal.:2015 12 20 (Rs05) Qdrfth
@ Iap iApplicatio." in the 'Updare" soe€n.

€) Wh.n updating i5.ompleted, rap'Done' buflon. Th* i.nrcma- E wilt rcrran automari.aly

(lhere
-n
i5 no SD card in orthe is no updalihg
ihe 5D ca.d not inlomaiion in a SD
card, chromar ! willdisplay. me$lqe for <h..kihg SD .ard.

Il is impoisibleto downgrade the application.

"S,o""OapE
21 tt}s 2018 6l0Xrt o/Ptrl.,
Dodment No. : oPM-IR2.EN
Dale:2016 12.20{Rd.O5) focrtth
S.iup > Syslem > Updal€ > Fimw.re

. Fimur. urdaiing using SD C.rd

O Opef the ba$dy.orer n rh€ botom of i.h6mar tr.
O hsen a 5D card whi.h in.ludes updating infom.tion inlolhe sD <.d slol as,ottowing piduE,

O T.p OK'butron to pro.ed Imw eupdarnq

O When updatnq ls completed, ichroma- tr willrenan automariotbl

ouring nmrare updalns, .hroma" tr on gene/ate ronrtnuols beep sound wtren imwarc
updaring s finished a ba.kup copy of the softwarc and r checkslm ofrh. innatblion fite are
rc.ord.d on rhe 5D .ad and i.hroman ]] willstop b*p solnd alto

Arpenop IOB (Aor MOapMa,

2 2 tt{08 2018 i:rc,xit*ot p1114"
Document No OPM.IR2,EN
Dlte 2015 12 20lRryOs)

trr,L i.hlma! tr Multi T€st iow.h.rr

I Turn ln€ power on

I
I
{Powa rwirch is locared in rhe /e r d..)

Ins.^ or regGlerID chip what yo! wanr ro ien

Tap "MultiTest'in rh. main scr.€n

You .an sklp following 3t pr.

lnsen sampe load.d lett.anr,dqo nlo ihe

.:(rcqe hodP.:nd t3p j:n .uron
lnpur p .ii ll rge:n. qender

T
I
I when all!*B are (ompleled, ruh the
I
I power oll ac.ording lo propern.ps I
t_

T€n samples lsinq in v. 06 t.n (an be nG.tiour ThecloE pt€$€ lse prot.dive
glows, nask and so on du.ng handling i.n srmpl*.
/r-,1\
l-a lJs.d can dg.r pipen€ Ips and samplej ehouid b. di*rrd.d a<ording tothedsm
Egiontl cgul.iions wilh h gh t.mpeEture .nd hiqh pcsuE n€rite.

A
Danger
Oo nor handl€ ichbmaE
If llu
Do nor 6ove i.h@ma- !
II with w.l hand..
fihd/l€el sme smok. or bu.ning smellr turn rh. power
ro oih.. place dunng tsi.
oaf imncdi.r.t

A Do nol 5tare in5ide ol i.hrcma- tr duing iesl

;,",,..}
"_ f
^/ / I00tuElrN.r. \'
a,pe*,op roE
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2 2 N1B 2019 \ 6 Crll.r{.r:rviA /
,\ t" rr --',,r,-,/
\ 2^\ ,/:,/
,

\,:,-,--"'':2'
DoNmMt No : OPMIR2-EN
Dale:2016 12.20 (RdOs)

ichroma'r D providB -Muhi T€si" .nd 'Single lesl" tun.rio.s

10-4j,r. Singl. T.it

1) Tap',Si^gle T.st"in the man s.rc.n th.n ichroman tr wil d]sptay folowng s.r€en.
2) Open a i.sr.adridge and ineen a lan.a ridge lhe.anrdg. hotderand tap "Nen'buxon
'nto

3) Ch..k whaher r.st irem, LoT numb$ and erpiration dat. mar(h th. contenk of r.r.an. (slme:imes LoT
number a.d erpnaiion dar. mry not be d spl.yed .(cordlng lo LOT nlmb.r ot i.h.om.n uem)

4) Inpul paii.nt lo(maximum 15 .haracle6), age End qend.r (You can skip lhk n.p)

5) T.p'Next'bunon. The. i.hronaE tr willdisplayl6t p6c.dur€.

Sonelima LOI numbs and .rptrarion date n.y not be dkptarrd .ccording to LOT
numb€r of ichomat It 6.

6) lnsen sampl€ oade! ten cadrrdse irio rhe.artddse hotder and iap "slart" but.n mmediarely

q,penop roa
"aox,ifriliJ '/ - ro!Jp, ..'
?.2 fr08 201s t,,],,"",:;;;L;;.
r5rrjritA4oApArA,
t'\.' , hj22j175r1
/
_ _ .-/.t",
ooom.nr No : OPM-IR2,EN

Oal. : 2015. 12 20 (Ra.05) Mhah

7) .h,oma_ ! di5plays reacton I me when rcad'on tr.ompeted lchroma! tr nansrheren auton .:lty

3)Whenlhe lest k.ompleted, i.hromar tr dkptays the ren rcsutr i. LaD and 5.ws ir in rh. inte.natmemory
You ca^ onnt lhei.n r.suh our

9) Ii you
t0) Pleas€
ffi
lap "OK'or'Prnf bullon, ich6ma!
discad lsed te c.nridge.
! goes back ro,Stngt. T€.1- s..e.n

Usen G/ddg.t piperie tps and sampt.s thoutd be disorded a(cordinq to th. retent
,€98n.' wnr hgh r€moeral"r..nd higr p,esu,e $erit..
'egulal'ons

1) Tap 'Muh Ien" n the marn s(een ihen E wil d sptay toltowing s.reen
'ch.omatu

Aupexrop ToB (sroxrMSapMa"

2 2 )fi08 2013
gffi_ no."*r*r, '6lCrX i lrlC A ir i\'1A"
Dodm€nl No : OPM-IR2-EN
D.le:2016. 12.20(Rry.Osl

3)lnpul patienl lD(maximun 15 chaiacte6),.qe and q.nder (You on skip thir st€p.)
loaded t6t ca.t dge hro$e can dge holder .nd tap '$an" bunon imm.di.t.ty

5) wn.n tests aG compleled, nam.s or t€ms .hd t.n resuhs aE dkpt.yld rnd 3.wd :ltomrti@tty
6) Yo! can delete disp ayed test rcsuli byseledirg snd lapping 'o€lete' bltton. And you.an pnm t n 6!hs

7) Please di*ad used t.n canrdigs

. ttow to r.t tim.r
chrohan E provides 'Mllti Timer' tunclion

FP -o
tl
@o
!t when rtu lap "Time i.on' ichroma" E dkplays'Sel Tim€(Mtn.), pop-up
wndow By tapping "+" and a" buron, you can set time(m.ximun 60

s
I &i
I

!/pe(rop TOB (SroxrMOapMa,

2 2 )r{08 201s
6 0xlt,toAPlvA,
Oocument No OPM-IR2-EN
Date:2016.12 20 (Rey05) hdir+h
To co^litu *tung timei lap "S.w'bunon
Ilr@ iap "S.ve All'bunon all r men are saved wth seni.g liEe

wh€n lime k ovei ch@m.- E sounds alam and time disptay wi[ be

To fn sh al.h round, rap reset butto^

(a Afts refiinq rime,lip 'i.n bunon-to stadtim.r rhen,stad bunon- is

Io paus.timer tap'Pause burof," Ih€n.Pau* bullon- i5 ch.nged lo

To reruh€ tim€r tap 'Stan butron'.

Il r@ tap "Reset b!no.' when timd is N. o. time is in p.use n.tu!,
-Tim. i.on'willbe chang.d
rorh. initi.tr.ning lih..

Allt.ttr sholld b. do.€ in clean and stable ptace.

B.lor. run l.st, pl€ase ..le.lo r.lMnt p.d.q. ic.n lor ..ch t8t.
Ex.6ir ,o..e dlring insening . ten c..rndge irto $. can.idg. h.td.r may c.!se
maltu.dion or eror in ichoma- tr.

Pl.ase Egkler i.n ile6 before tuhning test.

All td can.idg.s ar. disposabte ptea* dk..rd u*d carrridges accord nq to lhe

A .eleEnt and prope. egional.equtarions

When chroma" II wo.ks on 'Muht len- mo!e, ichromrtu E can tun 1OO tens

(,6u do not want to use inlemalt mei you can skip this s.tting.
Yo! caf skip inpu11ing p i.nr lO age.nd gender
Yo!.a. input p.tient ID by usinq barcode scanh.r (R.fer to ctause 112)
ll blili-in p nrd is not set€ded, 'print button is .ol display.d in lCO In thk cas., you
can p nt tha l.n resulls our by.onne.rng Pa.lRefd io daus€ 106.)

lo,a,a.l. syrt.m <h.ck t rt

a,pe*'op roa -aoi 66iJ "'-!?,,*",;",

2 2 NIB 2018
,,.,;;;;l'J;l
Doomefl No : OPM-IR2-EN
D.te : 2016. 12 20 (RdOs) M;1+h
10.4.4.2. QC h.t.nJ t st

i.hrom." E pbvid.s'M!hiTest" and -Single Test" du nq QC nar./ialt€n.

1)Tap'QC len QC Mal€nak > Mult tesl'Then thrcma E witt d irptay iolowing s.r€en.
'

x
2)Sele.t c.nrolname bytappin!.ed redangl. ar.a.IIlhere is no r.9id.r.d conl@t, pleas€ r€gist.r.ontrot
li6t (R.fer lo clause 1044 3.)
3)When you sele.t regisrered.onrrol, LOT numbe' of s€l?cted.onr@lG disptay.d automaticaly
,4)Load.onro to a ten (anridqe and inse r nto rhe enrdqe hotder and rap Stan, bllton mmediarey

5) Wh€n r.ns are.ompeled nanes of items and ren resu rs ar. d lplayed and sawd auroharcaly

T
6)You .an delde dGplayed t6t.esult by sele.i ng and lapp ng "Detele, bunon And you .an p .r r.d resllts
whai you eant io Plea* dEcad used t*t cadridge

r) Tap "QC rer > QC Maiara s > 5 ngle Tesr". Then .hroma" I] wiltdkptay roltowi.g s(en
2)Open a canldge pouch and insert a resl.a.lridg€ rnto the onridge hotder and tap,Next, blnon.

}*!-)
nvpe'<rop toe *sroxuGii6, (/r"".0, \.
7_,
"t,.*",,..
.'.rnoe \
2 2 )l{08 2019 1 ,1rn5a .,. \
6lOr lr'ioApMa.
\
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..N. , ,..-,/-
\l) ,-1;'
Do.ument No OPM-lR2-EN
Drte r 2016 12 20 {Rw.05) Mitth

3) Ch*k sterher ten ireh, LOr numbs .nd €xptrarion date nrch th. conl.lns ot *een (Sometimes LOI
number and dpnation date m.y .ot be dirptay€n a.cod h9 to LOr number of ichoman lem )
4) Select contolnam€. (LOT nlmbe' ol seled.n controtk dispt.yed aurooari.. )z)
5) Tap "Ne( buron Then ichromai" tr witd sphy ren procedure

6)Load controllo a iesr (anidge and n5ert lrnlorhe. rrdge hod?r and tap "srart" buron lmmedialey

re.dontime. when r.adon s (ompteted, ichroman E sra r the rest altomari.aly

jEIIE

3)When rh.ren s rc pleted,l.homa* E d sphF thelest rcsult in L<D.hd 3.ws it in the int.h.tEemory
You caf pnnt the resl r6uk out bybppng "prinf buron

.'^?9,.-"'".-
l/p€(rop TOB (EroxrMoapMa, ",iJi*i"',,7
2 7 I'ol ?1118
.
Dodmst No : OPMIR2-EN

D €:2016. 12.20 (idOs) M;fth

9. ryou t3p 'Or or'Prinf bulton, chbmatu E qoes back to 'S nqte Ten' scre.n
10 Please dB.ard used tesr.arftldge.

Sometimes LOT numbq and expnauon date may not b. disptayed accordi.g to LOT
numbd ol i.hrcmai ftem

10.4-lt.3. R.gLthtion ol Conrto, M.t.ri.h

1)Tap 'Control Lisl" button.

m
2) Iap "Conlrol lnnall' bullon

l) Tap -Contrcl Nam.' lhen ich@ma tr displays lkt ol.onlrok tiich .c pr@id.d by Bodhech Med l^c
Also yo! .an nput contro .ame by uling ba(ode s(anne.

2 2 )t{08 2010
"6toxlMoAPl\,'A"
Doam.nl No : OPM-IR2-EN
D.l. i 2016.12.20 (Rry.05) fodrleh
4) Trp "Contrcl Lot"
.nd 'Conlrol Exp: and nput rclaant i|fomalo. which a.e pint.d on lhe tabet ol rcnlEt
Then tap "Nen' bunon. In 6se o, inputring comrol name by Ginq b.rcode (annff LOT numbd and
r.rion date are nputi€d automan.at,

5) Inpul item n.m.(.!m€ ol te(), h.an Etu. and Lovhtgh timir. you can npul lhis ntormation by using

.rJd n.m,
lLlllIggtetE{l9l"si.t"r moc rhan 1 r€rr ilem, prease rap

7)Input rcl€Enr infomallon and rap'Sav€' blnon lor.ompteling rcgislEtion aherrapping

can find r.gistered contbtt in LCO scre.n

rr,--
4,pe*,op roa *EoiiS!ffi
2 2 lr{08 2018

Sloxlt\toAFMA
Dodm€nl No. : OPM-IR2-EN
Dal€ : 2016. 12 20 (R*05) hdrtQh
. Ch.cling intom.rie ol Egkr.r.d cohiol frxriJr
To .he.k inlormarion oI Gglnered conrol matetuls tap reqkrared (onrrot name vhar you wani ro .h..k
rhen you can.he.k nam€ o, leTr unit, LOT numbe4 expnauon dare, mean value and loqAqh imtr vatue

. D.l.r. infomation of r.gist.r.d @ni6t i.r.ri.ts

Trp .onrbl name whai you wanl to delete and rap "Detere' bunon To contnm det.iion, tap "OX" blnon
Th s intormarion wll be deleied p.rmanenrly

Yo! 6n i.put .ontol infoturlion by manuallnpul or wing barod. sc.nner

Wh.n you input contol inlo,m:ton by manual inp!1, pl.as. rnpur ebct and co .ct
nromarion lor LOI number and expirarion dne lncor€d inlomation nay ca!5e

Bar.ode s.3nne. is an oprional tem.Iiyo! want to pu.chase ir, please.onracr iegiona

dinribuloror Bodite.h Med In.! Sre5 dep.rrment.

Il user E9 ster the same.onto materalon lase ii.m, the lal.st inlo.m.rion wttbe

-.)
g'lpe-op roB;8,;;;6;;; / ;,,,
to=:',q \*
/ r oaMe*eio \
2 2 201s /",,rnou,r'n"'"'o i
'r{08 \ sroxruo.reun /
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\:; ,
--,-r'
Document No OPM-IR2-EN
Date r 2016 12 20 1Rry05) Qdrtth
10.5. R€view data
10.5.1. P.ii€nr Br E5uh

5 tesi E!h5 iap 'P .m resuli"

l)Fo. more inlomation, tap a lest raruh what you wanr ro .he(k

EE
Somerihes LOT nlmbs and expir.tion dare may not be disptayed ...ording to LOT
of i.hroma" Item.
^uhblr

6 60 ba* lo the prwious s.reen

Prnl seleded test resuhs our (Only avaitabte shen built']n p. nter is seled.d )

Send see.red ien Gsuts ro conneded pC US, WFI or Btueroolh.

l,perrcp roa .s,o"i$fri

'6loxlt4CAFflA
2 2 )r{08 2018
oo.umeft No : oPM-tR2-EN
Date 2016.12 20 (Rw05) hdifrh
when you tap lhis bullon afts selecting oie p.ii.nt Iq a[ t6t esu[s ror 3.lded
palient ID.E dkplay.d lfthere is no palient Iq lhis runction ir hot.6ilabl..

You can searh len results by inp!ttin9 ien dare, name ol ilem and p3ti.nt IO

r,l Go back io th. praious page.

s.ledng o/desel€ctinq listed t.st r6ults.

When lhB ie ma{.d on. it ne.ns lhat it.m k !.l.d.d

chmmaE 1I cah save up to 1,000 ren rcsuhs in ns im.mat m.mory Flnh.r lBr
resuhs are iawd auiomat cally and oldest tert rcsuhs will b. d.l.t.d.

a,p*-;rc=tG;;G;;
2 2 )tt0B 2019
,5IOX
IIOAPMA"
Doamenl No
\d;fth
OPM-IR2-EN
Dale:2015.12 20 (Rev05)

lO5-2.1. SFt m .h..k r.rt r.ruli

Iap 'Syn.m check".nd check ihe synem .he.k t.sr csults.

Someum6 LOT number and €rp ralion dat€ may nor be disptayed.ccoding to LOT
numbero, ichronao syslem che.k onridg..

Go back to ihe previous (rcen

Prinl sele.ted ten resuhs out

send sele.red rest resuhs to (onneded Pc, us, wrFl or Bluerooth

n Go b.ck 10 ihe prrylous page

.l sel€.ting or d6.l.cring listed ten resultr

Whd rhG is m.rked on, it me.nr th.i irem i5 5.|€cted

!,pexrop roe;61;;;;;;;
'6iox [icAi]r.r1
2 2 NlB 2018
Dodmenl No. : OPM-IR2-EN
D.le : 2016. 12 20 (i*o5)
10.s.2.2. QC mrt nJ tdt ..roh
Rwis /Buh > Conxol Sample
' QC
ich.onan tr provid 6 lu n.tions tor che.kins and monro ng QC ten r.suh. Thrcugh rhe* tuhctioE, ue en
prcvide prcp., qualty comrol method

2)Sel.ct LOT number of ren ltem, ConrotName and ConrotLOT and rap "O(" butron.

-3)lnfornaron olseeded nen n disphyed

506.l h5 LOT number .nd .xpi.ation dale E.y not be displryed r..ording to LOr
nufrber ol ichoman neh.

Go b.ck loth. p@ious <Gen

Prinr reled.d tdr r.q,lk 6rr

Arperop TOB (SrorMrDapMa,

2 2 )r{08 2018
'5lOXll"1OAPN'1A'
Doomenr No oPMIR2-EN
o.te: 2016 12 20 (Rdos) hditah
s€nd sel.ded r.st results ro co^h.ct.i PC, Ut WtFt or Btu€toorh.

T€ti r.sults are d splryed wiih graph typ..

g
m Go back 10 rhe prevous page

.l Sel.6ing or dB.ledinq list.! test.esutts.

Wh€n thk i! mr*ei on, it meanrrhal ncm is selected.

blnon iined ren r.tu k ,c wirh gEph typ€ as follM

i.hroma" E prcvid.e erfcient quatity.onvolmelhod by di.ptayi^g and an.tnng eC

10.6. Print test rcsuh

ichrom." E .an prinl t6i result out byusing bui[,in prinleror pC.onnedion

10,6.1 Pn,n r.tr rctutb out by uring buitt-in print t

1)ln.as. orblih-in pime.is hnalbd, you c.n p 16l r6uh olr imm.diat€t aner t.sr ir cohpteled.
2) To s.l buih-in pinie, pl€ase reier lo clause 10 3.6. Sysi.m.

nrpeFop TOB (SroxrMQapMa,

2 2 )r{08 2018 ,, ,j i, 1 ,","
",a " ",a "
"5tox ir4'!A .
I Pl,4/\
Do.ument No. : OPMIR2-EN
Date 2016 12 20 (R8.05) hddrh
P/inted (ontents e as folow
Run T6t E uh(.Enpl.) System Che(k res!h(.xample)

ITEM LOT :

mM Exp. : 2015.12.31

da,
P i.nrlD codml uiivderconrbll
Ico{mr urivderco bll I Resuh Synem oK
|Re !

Aqe 30 Lo)sror
| coftrct roT I ot
!e-de M.re lconrorE,o.:10151) | R.tuh. Nor AEitabte I

Resur:265 mglL ] R€sult:2.6s nglml

R.rer.n.e v.lue I Lo* Limn .

Somdimes LOT nuhber rn! expiratio. d.te may nor be dLpl.y€d accodi.g to LOt
number of ichoma- il€o

. Chans ns pnnrer paper

op.n the prinler.over and i^seh prinrer paper with.o..ed d redon as louow Then.to<e lhe pinter cover

when the prinls .over k .los.d, bullr-'n pinl.r ejeas pnnts pape. . tittte tor

Be c.retul excessive lo.ce wh.n opening or closn! the pnnle. (ow.lor prevenrtng
n.ltunction ol builtin prnter

2 2 NlB 2018
u,l*u,aunr,H'"t"
"6loxlMoAPL'4A"
oocumenl No. : OPM-In2-EN
Dlte : 2016.12 20 (R*.05)
(o.n..tion
Mdrh
10,6,2. Priht t.rt E3ult3 oui by PC
ichromaq tr 6n prnt t€st reruhs oul ry PC conhection.

To pnnt t.n .esuks olr by Pc co.n?ction the spe.iric software prorded by Bodilech

Thir tuncion willbe p@senled tn n.ar tururc.

lupexrop lOa.Sroxru6apMa,,
2 2 )t{00 201s
"6ICXihICAPIVA
Document No. r OP^,]1R2-EN
oare 2016 12 20 (Rw05) hcifth
11. Oplional

11.1. B.rcode s.ann.r

Barcod€ s.anns ii used roi ihpullinq user Iq palient ID or nfo/hsrion oi QC materatskonlrok).

A
I) Conne.t barcode scann.rto USB pod rti.h is o.al.d on th€..arside o, i.hEm.E n
Io use b.kod. scann.i sp..ifi. tetiing pb.edure for usinq barcode j@n.er is not need€d

11.2. X.yboard
You.an use keybo.rd insr€ad of iouchpad in LCD dkptarr

r) Connect keyb.ad ro USS pon which s lo.atei onthe r.ar side of chom.n
To us€ keyb@rd, specific s.t nq proc.dure for uring kayboa.d is nol neen.d

11.3. WIn Dongl€

ch.omatu tr prcvd€s wr.l.s intehet conne.tion using WIFI dongte.

//,,.
, -r.\\ \
// I ro",rp4
oDM!reHo! \
IE a,or rr b,,,.rD l
2 2 )l{08 2018

\ t 'ro4t,loAF
rti2l,,'r
UA
r' //
/
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\<);o;1or)'
Do.um€nl No. : OPMIR2-EN
Dare r 2016 12.20 {R*05) MrlQh

This tunction wll be presenled in near tulure

11.4. Bluetooth Dongle

'.h/oma" tr
povLdes suerooth ru^don

Thk tun.lion vill be pr.senred near tuiure

'n

11.5. SD card
You @n update software ol chroma! tr using SD aard
Pl€a3e rel€' lo clause'10 3 6 s updale"

11.5. ichromar II PC Conn.ctor Cable (USB OIG Cable)

ch.oma'" n provdes tun.lions ro. prin.n! by pC conne.lion

lo USB OTG pon which k to@r.d on lhe rca. sd. of ich@ma-

1) Conn€cr connectioh @bl€
2)Connect.on..ction.abte io UsB pon o, pC

'serup > Commufi@tion PC" Then i.hrom,- displays following sc.een.

'

n,pe*rop rOS;8,-;;6;;;
2 2 )t{08 2018
6 CXll\,1OAPl\4A"

-
Doomnr No. : oPMIR -EN
D.te:2015 12.20 (Rd.Os) fuddfth
4)To connecr i.homa" E to rc, t.p "ON'
Toconne.t ichromaB tr lo PC, the sp*ilic solt arc n needed. please .onracl rcqiona|
dist bllor o. Bodilech M€d ln( ! lechn ical su ppo.t team lor d€lail.d iniomation.

lo prinl t*l out by pC conne.l on, the ipe.ific aohwaro prcvided by Bodit€ch
€uns
M.d In.. is need.d. pl.rse conract r€gionalditt butor or Bodirech M€d Inds tedrniel
supporl leam lor d.lailed i^foftation.

11.7. AA bat€ry
ichroms" E c.n us. AA iyp! bate es innead olAC adaptor
To innalfset b.ti..ier please r.fer to sec1lo^ "8. Pover supplemeni'

Ur. of batteries is only aElabe n.ase of a bEckout for nst.nt operartoi Il s

imposlbl. lor normal !se with batt.rles for a long lire. W€ suqqast ro !se AC adrplor

A and pow.r.able lor n.ble rnd saie operation lt i5 posible 30 mlltiteslr o.2 shgte
rests wh€n ba{en.s aE uren
Itk po$ible to use AC .dapror and bane es simult.neousty
3!r w" (ggen &,erove b renesk... a( roapro,5 us.d

A For delziled infomarion .egardlng optional iems, ptease .onlacr regionat di*nbulor
orSodilech M.d Incl la.hni.a sales team.

2 2 )t108 2013
6 OX trloAPL'lA"

:) !_i
Do.ument No . OPM-IR2-EN
Date 2016 12 201Rd05) hdileh
12. Tioubleshooting

r.mediaU.orE.tiv. m.aiurct
Nothing happenr i<nromax I
Poo. conn.d on bawM the
d@s not show .ny lign ot R€move ihe power cable /
Poqer ad.pr€r and rh. pouer
adaplor and reconn€cr fihly

Pleas€ use AC adapror prwided

Please lum the power swkh on

Conl*l regional dinributor or
Sodhech Med In.! te.hni.5l

LCD is nol on or do€r not wolk Ch€ck therc a/e som.

elect6magndi. field emitting
deica arcund ichroha" n.
Plerle ins$ll ichro6.," ll .pan
fom thal krnds ot d.vic.s.
If probl.hs aE nor solv.d,
.onlrct rcgion.l d'nri6utor oi
god'(.ch M.d Incls l€chnical

Refs to -Norhing happens"

If p.obl€ms arc not solv€d

contad fegional dist.iblto/ or
Sodirech M€d Inctt teC^ntc.l

ichrom.' I doe5 not dirplay l.3t i.hrom.tu I in under 6lcul*i^g Pl.ase wait until ichrcmaq I
rcsuh.h.r conpl.tinq the ten

Il problens r.e not solwd,

contad caional distnbuto. or
Sodh€ch M€d Inc! lednl..t

The ortridg. holds does ool Conlact rcgio..l din butor or

Bodire.h M.d Inctr tedrntcal

Ir p.oblers ar€ not solved

contacl r.gio.al distibutor or
Sodlech Med Incls technical

A,perrop roe;E;;;6;;;
2 2 NlB 2018 SLOXllrlOAPiVA"
Some noise g€n€rate wnil. Conla.l Eqional distnbulor or
Bodilech [ied Inc! lschnca

It problemi ae .ot elwd,

conta.i .e9 onal disvibulor or
Bodil€ch Med ln.S t*hnical

Ope6tion iemperarlre k olt ol I menr rem p.Etu re is out ol Il is posible to poceed test. 8ut
^vnon
ope'alion lempeEture range(1s- test resuh may hor corect due ro
Dorlu wantlo pro..ed the te(? 35'(). operation lenperatur. is our ol
sugg€sed condhio.(15,35t).
Pl.as€ s.l .nvircnfrenl

It s mpo$iblelo prc.*d thetesl Conract /€giorul d strbutor or

Bodilech M.d In.3 t€chnical

ichrona" II k wo ing. Please The enridge hold€r ii movin! Pleas€ wall lntl rhe c trdle

In case of bpp'^g 'N.{" blrton Please insen te{ canridge 3nd

wnhour i.lenrng td canrdge ln

In.ase oflD chip is not Egirtaed Please nsen or regisre/ ID chip

or not regstered iren is r.sr.d
Some ilems are (ant be
regi(erci Please check items

Please.heck t.n canndge ln @se o, use of syslem .heck Il s lmpo$ble ro use syneh
candg€ in multi, 5inlle and .he.k crnridge h muhi, single
.ont6l natei,l< r.( m.n. and.ontfolien hod€ Iry the i.i
with p@perlcn.art dga
Ega n
Ch..k tystem che.k ID .hip In ca* ol tapping "Nett' button To proceed syslem .h..k, you
without systm check ID .hip should ins.d system .he.k ID
In case ofoih&lD chip is lns.rtad (hip. Please ins.n sy5tem .he.k
ID .hip and try syri.m check

Che.k LoT number ol synem LOT number or rrsleh che.k Please chect LoI nlmber and lry
che(k ca.rridge and ID chlp canridge and ID chip do not

Srdem che* canndge is qpnei. ln(orecr ser ofdare and time. Pleas. check dare and rime in
Do you want ro prn.ed tsrem

2 2 )t{08 2018

'5tox [/oAPr.rA"
Oo.umenl No. : OPM-IR2,EN
Drl. r 2015 12.20 (R405) Qdrtfth
Sysl.m .h{-k onridqe s expi.ed. In cas. ol erpnation date ol
sYstem ch€ck candge is de,; it
i3 po$ibl. to proc€.d syliem
ch€.k pr@dur.. But it m.y c.!s.
incore.l system che.L l6t r€slh
In .as. 6l .onxol maier a s ien is Please nput hrm. ol.ontbl ahd
*aned wilhour s.ledng nam€ of

Pl..s. innalVin5€.t printer paper

It problems ac not solEd,

conta.t r.elonal ditlibulo. or
Bodh.ch Med l.cl te.hni.al

It is i6po$ble to search items In cas. of 6.r laes to sea.ch Ir.n rcsuh inrorm.tion do€s not
whi.h are nol,n(luding pai ent lD items whlch are nol in.ludi.g i
in.lud€ parienr Iq is imposibl.
ro learch lesr BUk by palienr ID
Pl€a se ch.ck p.l ient ID ir in.lud.d
in lhe iesl Esut intomat on.
There is no seled.d dac In ose of lappng -Pnnt" or Pl€ase select data whal you wanr
'oelete- blrton wirhour teled n9 ro print o. delete and try again

lnplr user ID with hore than 2 h case of inpun€d lser lD wilh Pleas. inpur ID .gain with morc

l^pur password with moc lhan 2 h Gs. of inputted p.5swod whh Please input pasiword wih moE
only 1 ch.ra.r.r duri^g user IO

In care of inpltt€d paswod and Pleaie check inpufi.d p.$word

Che.k you/ passod and ny confirmation Oasrc.d do hot
iarch du n9 !5.r ID ..gistEtion.
Ths lO L.kaady registered In (.s€ ot inputted user ID is Pl.ase ch.ck user IO a^d try
already req ftrcd/er n dunnq

ichromaD llen rcgister maximum The number ol rcginer.d user ID d..s. d.lete Ber lD a^d rry
exceed 100 d! n9 user ID

In .ase ol tappino 'Or buito. Please inpur userlO and tyagain.

witholtinp!itlig use.lD
I. case of tapping "OK blrlo^ Please input passwod and try
wirholr inp!trin9 parsword

f"".1",',., \]
2 2 )l{08 201s

6lOXlr"1t rPiuA /

S;-.:;/r
Do.UhenI No OPM IR2'EN
Dare 2015 12. 20 (R.v05) hc;fth
13. Error code
ie.ohmended Renedial / Coredive

T*hnicl problems in t6r

Try:9a n rhe ten wnh n., test canrdge.

Tuh lhe pows otl and .ont.d regional

dlsnibltor or Bodit.ch M.d ln.! trh^i.,r

Improper sample or bufter s Try agai.lhere.rwhh helen.ad dqe and ren

T4hnic.l p.oblems in t6r

Try aqa n th. ten wilh neq ten can.dge.

Che.k b.rcode oh test .:nridqe ir dahaged or

conramrnar.d by loreign mate als

Problem ln id.nr fcal on o,

lrued td .anridqe i.lo rhe .arrridqe hotder to

bar.6de on len canrdqe

Il p.obldns are not solv.d, contad .egonal
dislibutor or Bodile.h Med tncr5 technt.al

IO .hip ahd len cartidge do Match lD .hip and ten (anridge. Then try again

Tryagain after ch€.king us.rID and passord.

LOT number ol ID dip and tesr Mdtch LOI nlmberollD chip and tesr c.fiidge.

Change l0 chip and rryaqrih wilh newtD.hip

lf pbblems lrE nor sohEd, coniacl rcgionat
dslnbltor or Bodirech Med ln.r3 r..hni.:r

Te* tem 5 not included n Contacl eglonal disributo. o. Sodt(h Med

lncls techni..l su ppo team.
^
Optical l:ilure du ng selt- Cont.cl regio^al distibuto. o. Bodnech Me!
ln(3 re.hniGl suppo^ ieam.

4,pe(Top roa-so"i6a-ffi
5l cx I ArlOA Fi\,4A '

2 2 )t{08 2018
Do@h.nt No :OPM-IR2.EN
Dat.:2016 12. 20 (Rd.os) hciteh
Moving p.rt ,arlurc durinq s.tt Coniact Egional dist butor or Sodr*h M.d
Incl i€chnical support team

Ihlemal slor.g. failu.e dlrng Conla.l rcqion.l ditvibulor o. Sodt*h M.d

lnc! iech n ica I 3uppo.t tea6

I is po.sible to proceed i€s Bur ten Esutr nay

Tmperalu.. *nsor failuE
du ng self-t.sting pb.edure
Suih-in printer tailur. dunng
Environmert lemperatlre i5 oul
of opeGnon tenp€ralure r:nq.
du. ng selr-lesling pro.€dur.
nor .on ct due ro opeEion remp.ratuE k out
ol sugg6ren .ondirion(15-35 8).
Comd reqional dhributor or Boditrh Med
Inc.t i.chnical suppo te.n.
ft is posible lo pro.€ed t*t Bul n is imposible
ro prinr the ten resuh our
Co ..r r.gional dkl.tbltor or Boditech Med
In.3 te.hnical suppon le.m
Il i5 po$ible lo p6c.€d t.n. Bur ien r.sult may
noi .orE.l du€ to operarion l.np.Et!.. ls oul
ol suqgesred condition(15-35t),
Please 5et €nvionment tempeGtlE as 15-35t

2 2 )r{08 2018
0o.umenl No OPMIR2'EN
Dare:2016 12 20 (Rev05) Qdirfth
14. Warranty

ichbms" I hrs pa$ed sr <l qualiiyasuhn.€ and lenng prcc€dures

Bodlt*h Med Inc! expEs.d and implied waftmi.s aE.ondiionatupon tuttobs.france of Bodir.ch Med
lh. use ot Bodil(h M.3 tn. s prodlcts.
lnc.'s published diEctions whh respect to

(lnder no .ncumnan..s whatsoev€r shall Bodit..h Me! lnc. be h.ld li.bte for any indn d or.ons.quentiat

s.dice tha consumer mlrt .erurn the detectiw i(hroma- n unit or any .omponenl
To avail the waranty
rher@t alonq whh prool of pur.hase ro Sodte(h rvted In.. or it,! nearen Aulho zed Setoice Agcnl

Dur nq the waranty peiod G2 monthi irom lhe dale orpurchase), dete.tive o. sponianeous, majtunaionins
ich.oma" n or it! cohponenr(t) wittb. Epaned lr.e ot.ost or nay be .ompensai.d for in ac.o.dan.e with
.onsumer protection /ul.s and rcgularons

The consum€r may be.harged lo. rep. r of ich,oman g den dldng the w.ranty peiod ih folosnq.as.s:
- lmp.oper use or misus€
. Conslme/s int.ntionalm shandlin!, abus. or neg ear oflhe productG)
. Lnaurlo zed ..patr /,eplac.me-r ol or rh.uol r..y.oapone, r

. Miss ng oi wa,anry cald or i.tentionatmod rcation oi rntormalion in war.nq,.ard

- Damages or deleds due to rir€, pollurion, €aftquake o/ orher nat!.atdkasr.6

Fo. aftersalee inquiry please.ontactl

Boditxh M.d L<ooorat.d

43, 6eodldanji 1-gil, Oongnae-my€on, Chun.h.onj, 6ang-won-do 24198

Phone No: +32 ll 241 1400 / F.x No: +32 33 24t 9373

E'mal 5uppoft@bodn..h.okr/Webrlerw6!bodie.h..['

.i, \ \
+/./ :rooapu
16',r:+esr- \'
Arpe*rop rOg *601 6]ii]]
2 2 )t{08 2013 SLCX l,40APl\,4A"
Document No. OPMtR2-EN
Date:2016.12 20 (Rry05) hdfrh
Warranty card
Thank you for purchasing ichroma" I]

Please fill the requned information and send a copy of thk watranty card within 30 days of
date of pur.hase to the above address.

12 months from the date of pu.chase

Year lvonth D.v

i.l,o",*-E','."-G*,, l::r'"1"*!
2 2 )tl(rB 2018
l rH- ,"""*,^,,1 ri:rm1;1;
;. ,l
www.boditech.co.kr

Respect for life

Bodiiech Med Inc,

43. Geodldani i-ur,Dononae' veon,
Chuncheon-si. 0ad.-vroi.dd 24398 (orca
Iel +s2-33,243-tit00 tu: +82.3$213,9373
lrcEl{lila, 3!5 lul :rt! ,r+ar r,; i312{393j

obelis s.a
Bd. G6ned liahN 53, 1030 Oilssrls. letgium
Tel +132) 2-?32'59-54 Faxr l{321 2-732.60-03

a,,per.op rOe
"E'ox;6;;;
22 il108 2018
:i,:,T'ili:"ffi
;.",""1