Boditech iCHROMA II User manual

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Document No. : OPM-IR2-EN
oale:2015 12.20 {R*05)
Th. inlormarion cohrai^ed h.r€in is suble.t to.hang€ wiiholt prior noti.€. hc;tah
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
{ 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 [email protected]
D.r. ot l.rt Evi3id : D.emh.r 20, 2016
ft
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Tabte .ontenrs
11.6. ichEmaB lt DC Cdn*tor C.bt. (USB 016 Cabt.)...,,,......_..._........,..................... ,.. ................ ..50
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Document No. OPMIR2-EN
Date 2015 1? 20 (R40t)
1. lntended Use hritrh
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 "sed i. (lean pl.c€.
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
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2 ? tilll 2015

Doom€nl No : OPMiR2-EN
Dal€:2016.12.20 (Rd05)
leave it operation environment at teast 30 minutes. hdrfth
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 '(hroma" E in chem,cats srorage o, gassing arca
10) Remove power cable if ichrcmar tr is not used ,or a tong time.
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 rechnical suppo 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.
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2 2 N)B 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€.
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
t
Separate colleclion for electri.a and eledroni. equipment
L]SB
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
VaroLrs symbols are !sed in th s manual as follow
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"Caution" is srillsom€times used ro have rhe meaning of;enention,
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 fi uor*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
The [email protected] micropoc.se. compotes conce.rrat on ofrh€.n5lyr€ in the ctiaicatsp*imen based on a pre
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)
Oo.umenr N. oPMJRT-FN
Date 2016. 12 20 1Rd.05)
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Dodmenl No. :OPM-IR2-EN
oale : 2015. 12. 20 (Rry.05) hcirsh
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ooom€nr No : OPMIR2-EN
Dai. 2016 12.20 (RerO5) hrdrh
6. Technical specif ications
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
Fluores.ent Immunoa*ay

DocUme.I N6 : OPM-IR2.EN
Dde: 2016 12 20 {Rd.05)
7. Funational and operational elements
Front side view of ichroma" tr
fodrteh
You.an inpulvarious need.d in,ohatio. lor tBti.g I,y rouchpad ol
--O LCD d sohr6 vaiou! irponant '.,omaron i!(h as a.@s
natus r.n '.!uh<:nd $ 6i
lnsening rest.a idge for proceeding resrs.
Holdercore.k 6rlighl /dun /lorciqn mat€.iak prs^tion
It measurcs oohtempeElurc arcund ichroma" tr.
For deta l.d infom.tion rcgarding oprional items, ptdse coftcl @qionaldkhblro.
or Sodr(h Med In.3 l{hni.al qles leam.
ATemperaturc s€nsor measures @m t.mpebture Oo hot chanqe lempebtur. by
i artional heatingorcoolnq.
Do not insr.ll i.h@ma- u in.E: whkh has big remp.ratuc v.nat on
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Bottom and r.ar side view of i.hromat Ehdifth
When the banery cow i. op€n€d, you cn i.statt/set baft.riB and
Connedion pon for AC adapi.r
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
Connedion pon for Etheher connection
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Do.ument No OPM-lR2-EN
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8. Power supplement hritth
I
. 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
1) Open lhe batiery c@r ir th€ bottom ot th€ th6mrE E. Ple.se dred( lh. diredor ol6ane es and
inse rh.m with.or..r dic.rioh
2) Closa rh. batt.n/ covs and pur rh. i.h@ha, tr on nghr postion
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Danger
Power 6lihg 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
pows cable providen by Boditeh Med Inc only and chak power rar ng belore use.
lr you can't <onim power Eting, please conslh wrh your ladllty manaqement offic.r
when using bafteie' please ch(k the rype of bateries IAA ryp€) and indall rhem
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$lblelo useAC adaptor a^d banen.s simuhan.oudy
But we suqqd lo remow ba(er.s when AC adaDlo. is lsed
Pl€.se do not usa a p nlerqhen l.hrcm.- II ir operaling wirh bafieiei
Use ol a pnnler.a^ cuse power down due ro.x(essive powerconslmproh
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oo.umenl No oPM-IR2-EN
oare: 2016 12 20 (iey05)
9. Installation
R.Lr to Section I aad S€ction 3 pno.lo inrt.tt.tion.
l)Wh€n loading i5 completed, i.hroman tr witt prcce.d
l) connect . porer cod .hd ac ad.pto, [email protected] by sodn*h Med In.. to ih. pows port o, crr sid. of
'.h@man IL Th.n lum th. p4r eritch on.
2) ichrcm.E IJ displays the p6du.r logo .hd toading screen sen.lt when t@ding, it t.kes few se.onds
It loadinq screen lasts more ihan 5 m nlr€r plers€ rlm ichomar E oft and lun it
on again.lrsrm. probl.m k oc.ured, pt€.s. .a ti Sod ilech M.d lnc! lechni.:tsetutce
or author zed r.qional dl{nbllor
the self-i€n n9 and display rhe selilestinq rcruh5
Synem ol throms" E k
Iher€ are some pEblms in
th€ r.l€wnr pa.ts or
t mpehrlE ir out ot
2 2 'fl08 2010
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oo.umehr No oPM-IR2-EN
Dare 2015 12 20 (Re05)
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-tur. orl Iurn the dev.. off and calllo manufactu€ or authoized.egiona
Ignore: You .an proc..d the next nep but ir is imposible lo i€n items
Tenpei;ture sensor Ercr
It , ,o$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
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.
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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
2 2 ,l{08 2018 5 t ox t rr4 0A F l!,1A,

Doome No : oPMIR2-EN
oare 2016. 12 20 (Rd.Ot)
Ihe actual .ont.nts ol th. display .ould ditt r, depending on the sp€citi..uon and
is.omplered su...$tult lhe ich.omat tr wttldkptayth. narn 3.ren
A
Seltlesling items are .t rollow.
1. Ddvinq pan.nd pinter (.tt n onethem.l p nter k adopied)
4. ropeEllre (enrrcnme remp.ratu.e)
Do nol d sa$emble the l.hroma" tr vhen som. eaou ..t€wnr to s€lf.tenino ir€ms
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
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2 2 NlB 2018

Oo.umenl No OPM-IR2 EN
Date:2015 12 20 (Rey05)
10. ichroma* II operation hciteh
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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oodme.r No I oPMIR2-EN
oale 2016 1? 20 (Rey05)
. 2) DB.riprion 6t.rrh i.on Qdrfth
ttntE Displaying batrery status when the ich@ma- E k operaring
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
Red : Environmenr t.mp€rarure ir @i otrhe r.ng. ol 15 -
3Sra
Thi5 iconwillbe displayed when WIFI s connert€d.
Ihie i.on wlll be displayed whe. Bluetooth ir .onnected.
This icon will be dLplay€d wheh Eth.h.t k 6nn.cted.
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Dooment No OPMIR2-EN
Date 2016 12 20 (Rryos)
10.2. System check Mrteh
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)
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
nto lhe lO ch p pon and rap rhe'Nen" button on rhe LCO
tl,pexrop rOg .Sror,MO;;;;
l)Thenthe ich@6a" E willej.cl the cadidge holder aulomari.allJ.
2 2 )l{08 2018
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4)lnsert a stsl€m .heck 10 chip
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Doom€ni No : OPMIR2,EN
oal.:2016 12.20 (Rd.05) hdrtQh
.he.l canridg. eith co@d dnedon and rap lhe "Sian. bulton.
2 2 'ltos 2018
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
11 loq in rundion is not usen, ihe ichroma- E wil dispt.ys GerID as L,t
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.
Therc arc sohe problems in
5r5lem .h{k cartrdg€ or
Check lnerc a.e foreign nal€rials or dahag.s in a
system canndge and try ag.in synem che.k
Call Bodil€ch M.d Inc3 Tech.i.al s.M(e or
altho zed Ggion.l Epres.ntrtive it nhe
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Thd. .re som€ pEblemr in
rrstem .heck @nridge or
Ch.ck th.E arc loeign mat nals or dadas* in a
sy51em ..nddg€ .nd lry agri^ system .h€ck
Call Sodte.h Med Inc3 Technicrl s.ryice or
authonzed regional cpEs€nrati€ il s6e
A
It is imposible to identily a
bar code on a synem .he.k
Insed a sy{em che.k ..nridqe in rh. .art.idqe
Chak lheG arc lor.ign matarals or damaqes on a
brrcode ola system canidqe and tryaqain rynem
(all 8odit..h Med In.:s Ie.hnical letu(e or
authonzed raqionrl repreenlaliw if sam.
A
Lor nunbeG oI a sysrem
ch€ck cnridqe and sJ6lem
check Ig (hip do nol march
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
aulhonzed r.gional rcpeentatiw I sahe
Doomet No : oPM-IR2.EN
Oate: 2016 12.20 {Rd.05) hdrfth
Trvou Ld" p d 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
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'5,ox,n,oorrol
2 2 )li0B 2018
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