IChroma Operation Manual

7/23/2019 IChroma Operation Manual

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i-CHROMAT

M

mmunofluorometer Equipment

Reader

Operation Manual



I Quick Manuals E.1

II Introduction and Principle of Operation E.

III Contents of !"stem E.#

I$ !pecifications E.%

$ Initial Installation Procedure E.&

$I Printer Installation E.'

$II Operation E.(

$III )arnin*s+ Precautions+ and ,imitations E.-

I !er/ice+ Maintenance+ and 0isposal E.

Trou2le !3ootin* E.14

I Contact Information E.11

En *l i s 3

TA5,E O6 CO7TE7T!



!ection I

Q ui c k

M an u al

I

Re/. 14 E.1

6or finis3 a test+

press 8In9Out: 2utton to put t3e 3older 2ack

Po;er !;itc3 O66

Quick Manual for TE!T MO0E

I

II

III

I$



This manual contains the introductions for the operation of i <CHROMATM

Reader and for the sample testing procedures. Refer to the test procedure of

specific product for specific test and operating instructions.

i <CHROMATM Reader, manufactured by BodiTech Med Inc., is a portable

instrument for fluorescence detection to quantify concentration of various

kind of analytes in blood or urine. The assays and the instrument are for in-

vitro diagnostic use only. i <CHROMATM Reader can be used in a central

laboratory or in a point-of-care testing facility. i <CHROMATM Reader uses a

laser as the ecitation light source. The emitted light from the fluorescence

dye is collected and converted into an electrical signal. The signal is closely

related to the amount of fluorescing dye molecules present on the spot under

eamination.

!fter a buffer-mied sample is applied to the Test "evice, the Test "evice is

inserted into i-#$R%M! Reader and the concentration of analyte is

calculated by a pre-programmed calibration process. i <CHROMATM Reader

can accept Test "evices that are designed specifically for use &ith this

instrument.

!ection II

Introduction and Principle ofOperation

I nt r od uc t i on

II

Re/. 14 E..1



i <CHROMATM Reader is equipped &ith a built-in Test "evice

holder and does not require an eternal holder to place the Test

"evice in. The Test "evice holder &ill appear through the

opening on the front surface of the Reader.

The main po&er s&itch, located on the left side of the instrument,

po&ers the i <CHROMATM Reader. The optional printer comes

&ith its o&n po&er supply. These t&o po&er supplies have

different po&er ratings, and a critical damage on instrument can

thus be resulted in if po&er supplies are connected incorrectly.

'o&er supplies are labeled, indicating that &hich unit are

supposed to &ork &ith.

I n t r o d u c t i on

II

Re/. 14 E..



!ection III

Contents of !"stem=npackin*

!fter opening the bo, compare the contents &ith the list belo&.

Contents i <CHROMATM Reader set

i <CHROMATM Reader 1

Operation manual 1

Po;er ca2le for Reader 1

Connection ca2le 1

Printer set >Optional?

T3ermal printer 1

Manual for printer 1

Printer paper >roll? 1

Pipette set >Optional?

Pipette >14+ 4+ #4+ (&+ 144ul? 1

Capillar" tu2e >&ul? 1

!"stem C3eck C3ip set

Cartrid*e 1

I0 c3ip 1

Cont e nt s

III

Re/. 14 E.#



P3"sical 0escription

"imensions ()* + /) +0 /* +$ mm

0eight ( kg

'o&er supply **-(1*2 !#, )*34*$5, *.)-.6!

"ata output7 %n-board screen 3 'rinter

En/ironmental !et<up

Temperature )o

# 86*o

# $umidity * 8 /*9

ocation "ry, clean, flat, hori5ontal surface a&ay from

direct sunlight and mechanical vibration.

Optical 0escription

ight source aser diode, (.) m0, 46:nm

"etector ;ilicon photo diode

Ot3er

"river Motor (2

Interface R;-(6( serial +I3% port

'rinter Thermal

"isplay #" +41 character

<ey pad ) function keys

@@@ T3is de/ice meets t3e EMI *uideline as per E7'4'41<1<.

!ection I$

!pecifications

! p e c i f i c a t i on s

I$

Re/. 14 E.%



!ection $

Initial Installation Procedure

Po;er requirements

i <CHROMATM Reader &ill &ork on household po&er line, *-(* 2

or ((*-(1* 2 !#, )* 8 4*$5. If you are uncertain of your po&er line,

consult &ith your utility manager.

,ocation

i <CHROMATM Reader should be placed on a dry, clean, flat, and

hori5ontal surface a&ay from direct sunlight and other source of

electromagnetic radiation +po&er transformers for eample.

To set-up i <CHROMATM Reader for the first time, remove the contents from

the packing materials. Inspect the contents for any physical damages and any

missing components compared to the suggested list of contents.

. 'lace i <CHROMATM Reader on a flat table

+surface, &ith the front surface at least 14cm

inside of t3e ta2le ed*e.

= #onnect the po&er cord for i <CHROMATM

Reader to the &all po&er outlet.

= #onnect the po&er connector to i <CHROMATM

Reader.

R e a d e r

I

tllti

$

Re/. 14 E.&.1



1. Turn on the po&er s&itch on the left side of i <CHROMATM Reader.

5. i <CHROMATM Reader &ill eecute a series of self-checking routine.

>pon successful completion, the display monitor &ill sho& the initial

screen as sho&n belo&. +The actual contents of the display could be differ,

depending on the specification and customer requirements.

Caution Beep t3e ca2les+ cords and ;irin*s for t3e po;er adapter

and t3e printer a;a" t3e front and t3e top surface of i <CHROMATM

Reader. T3ese could render it 3aardous to connect9disconnect t3e

po;er adapter >and t3e printer?.

6. i <CHROMATM Reader is no& ready for use.

:. !t the end of the run, remove the Test "evice from i <CHROMATM

Reader. !lso, make sure the sample holder is retracted before turning

the po&er off.

M E 7 = 0 1#1#44

@ Test Mode

!ettin* Mode

R e a d er

I n s t al l a t i on

$

Re/. 14 E.&.



!ection $I

Printer Installation

i <CHROMATM Reader comes &ith an optional printer that preconfigured

to &ork. ?or proper handling and installation of the printer, refer to the

instruction manual accompanying the printer. 0ith the printer ready for

operation, you can connect the printer to i <CHROMATM Reader follo&ing

steps listed belo&.

. #onnect the other of the cable to i <CHROMATM Reader.

(. @o& the printer is ready for operation.

6. Turn on the po&er s&itch on the left side of 'rinter.

P r i n t e r

I

tllti

$I

Re/. 14 E.'



!ection $II

OperationThe operation of i <CHROMATM Reader is performed by five primary

functions each of &hich can be represented by corresponding key pad on

the front panel. The soft&are in i <CHROMATM Reader is designed

concisely and user-friendly to be used in a point-of-care or a central

laboratory setting. Aach of these functions is addressed in this section.

6unction Be"s

The cursorC in these descriptions stands for the DDC notation.

This function selects and eecutes the command at the cursor

position

This function moves the sample carrier in and out of the main

body of i <CHROMATM Reader. This key is also used to finish

the run7 the sample holder stays etended at the end of the run

and this key retracts the holder back into the main body.

This function returns the screen to the previous mode.

This function moves the cursor up a line on the display &indo&.

This function moves the cursor do&n a line on the display

&indo&.

O p e r a t i on

$I

Re/. 14 E.(.1

Down

Up

Reset

Select

In/Out



Procedure for !"stem C3eck

The follo&ing steps describe recommended procedures for a test in i <

CHROMA

TM

Reader &ith a ;ystem #ontrol "evice.

On<!creen displa"s and applica2le steps

0hen you turn po&er s&itch on, you &ill

see CME7=C onE;creen after 8!elf Test

Mode:.

Insert

I0 C3ip

#hoose Test mode: by moving cursor &ith

=pC or 0o;nC key. 'ress !electC key to move

net stage after you chose a specific mode.

Insert I" #hipC is displayed on the screen.

Insert a ;ystem #heck I" chip.

Ope r at i on

$II

M E 7 = 0

1#1#44

@ Test Mode

!ettin* Mode

Re/. 14 E.(.



!"stem C3eck

Readin*

Pro*ressin*

i <CHROMATM Reader &ill scan the ;ystem

#ontrol "evice automatically.

'repare a ;ystem #ontrol "evice

!nd then, you should do a test

Insert a ;ystem #ontrol "evice into the holder

after a sample loading .

'ress !electC key to start.

Insert Control

Cartrid*e

!elect to !tart

!"stem C3eck

!"stem OB

The test result &ill sho& up on-screen. Fou can

also get the print-out of test result.

If you press ResetC button, ;creen &ill return to

ME7=C mode. @o& you can run another test.

O p e r a t i on

$

Re/. 14 E.(.#



Procedure for Test Mode

The follo&ing steps describe recommended procedures for a test in i <

CHROMA

TM

Reader &ith a specific Test "evice. Fou can use only&hole blood for test +@o serum or commercial controls

The actual display may differ from the ones shown below, depending on

the factory configuration of the Reader .

If the scanning is stopped by accident or error message is displayed on the screen,

you will hear an alarm sound. Please check out the cause of alarm sound.

On<!creen displa"s and applica2le steps

0hen you turn po&er s&itch on, you &ill

see CME7=C onE;creen after 8!elf Test

Mode:.

Insert

I0 C3ip

#hoose Test mode: by moving cursor &ith

=pC or 0o;nC key. 'ress !electC key to move

net stage after you chose a specific mode.

Insert I" #hipC is displayed on the screen.

Insert a proper I" chip &hich you &ant to test.

Ope r at i on

$II

M E 7 = 0

1#1#44

@ Test Mode

!ettin* Mode

Re/. 14 E.(.%



3sCRP Test

Readin*

Pro*ressin*

OO D

i <CHROMATM Reader &ill scan the Test "evice

automatically after 6 min for immune reaction.

'repare a Test "evice and apply sample miture

onto the Test "evice.

!nd then, you should do a test

Insert a Test "evice into the holder after a sample

loading .

'ress !electC key to start.

Insert 3sCRP

Cartrid*e

!elect to !tart

3sCRP Test

O.O m*9,

The test result &ill sho& up on-screen. Fou can

also get the print-out of test result.

If you press ResetC button, ;creen &ill return to

ME7=C mode. @o& you can run another test.

O p e r a t i on

$

3sCRP Test Reaction

Pro*ressin*

4& 44

Re/. 14 E.(.&



ME7= @ !E,ECT

!ET @ RE!ET

"ear. mont3. da"

3our min

8Time !et: mode is for date3time setting only

&hen you activate the instrument for the first time

or reuse after not using the instrument more than a

month. !fter pressing ResetC key, you can set year

blinking &ith =pC or 0o;nC key.

Procedure for Time !ettin* and

Recall Pre/ious Results

#hoose !ettin* ModeC and 8Time !et: or

Recall ResultC by moving cursor &ith =pC or

0o;nC key. 'ress !electC key to move net stage

after you chose a specific mode.ME7= 0

1#1#44

Recall Result

@ Time !et

PRE @ RE!ET

7ET @ !E,ECT

"ear. mont3. da"

3our min

>se !electC key to move year to month to dateto time &hile setting month3date3time &ith =pC

or 0o;nC key. 'ress !electC key to go back to

Menu mode &hen you finish setting date3time.

Ope r at i on

$II

ME7= 0

1#1#44

Test Mode

@ !ettin* Mode

3sCRP Test 41

44.4 m*9,

"ear. mont3. da" 1#1#

8Recall Result: mode is used to store and recall

previous tests. Fou can store up to ** test results

and can also print the test result. Fou can find thetest result by searching date and time of the test

&ith =pC or 0o;nC key. ?or printing the

previous results, press !electC key.

Print 0ata

@ OneAll

#hoose OneC mode for single result or AllC

mode for total data &ith =pC or 0o;nC key

and then press !electC key.

Re/. 14 E.(.'



• The test sample should be applied to the BC &ell, as sho&n belo&.

Caution in 3andlin* t3e cartrid*e

= 0hen inserting the Test "evice into the holder, orient the Test

"evice in such a &ay that the BC &ell should be to&ard i <

CHROMATM Reader. This direction is also marked &ith an

arro& on the Test "evice .

= 'ush the Test "evice all the &ay into the holder until the Test "evice

comes to a stop. >se only the push of your thumb or the inde finger.

"onGt use of ecessive force on the Test "evice, or it &ill result in a

mechanical failure.

= The spent Test "evice should be treated as a potential bio-ha5ard and

should be disposed of according to the standing ordinance. 0e

recommend high temperature autoclaving, follo&ed by incineration.

A

B

A B

O p e r a t i on

$I

Re/. 14 E.(.(



"o not insert anything other than a Test "evice provided by the

manufacturer into the sample holder.

"o not immerse i <CHROMATM Reader into &ater.

"o not spill any liquid on i <CHROMATM Reader. This may disable the

system.

"o not drop i <CHROMATM Reader.

"o not subHect i-#$R%M! to mechanical shocks heavier than light taps

&ith hands.

"o not open i <CHROMATM Reader &ithout &ritten authori5ation from

its representative.

"o not place heavy obHects on i <CHROMATM Reader. This may damage

the optical alignment to result in degraded performance or in mechanical

damage.

>se only the po&er adapter provided &ith i <CHROMATM Reader.

>se i <CHROMATM Reader only in environment as specified in section

IV .

>se the test result as a pre-screening guide. The result should be

interpreted by trained medical personnel only.

!ection $III

)arnin*s+ Precautions and ,imitations

Cautions s3ould 2e taken to use i <CHROMA

TM

Reader in settin*smeetin* t3e requirements specified in Section IV of t3is manual and

in o2ser/ance of t3e ;arnin*s in Section VIII . If used ot3er;ise+ t3e

2uilt<in safet" features of i <CHROMATM Reader ma" 2e

compromised to present se/ere electrical+ mec3anical or 2iolo*ical

3aards to t3e user.

) ar ni n * s

P r e c aut i ons

$III

Re/. 14 E.-



!ection

Trou2le !3ootin*

#all customer service.Internal Alectrical orMechanical ?ault

Message7Arror (8(1C

>serGs action is not required. @ormal mechanicalsetting

#licking noise&hen the holderetends

#all customer service.Alectric circuit failure

round the surface of i <CHROMATM Reader to electricground terminal. Remove any sourceof electric charge. Reset the system.

Alectrostatic shock "isplay does notfunction properly.

Turn off the po&er and startfresh

;oft&are !bnormality

#all customer service.Mechanical failure+Bu55ing noise;ample holderdoes not sho&.

Turn the po&er off and on again.#omputational!bnormality

0ait till the computation isfinished.

Acessivecomputational loadRun finished and

no resultreturned.

#all customer service.?aulty po&er adapter

Turn on the main s&itch.Main s&itch is off.

Remove the po&er cable +from;M'; to i <CHROMATM Reader and reconnect firmly.

'oor connection bet&een the po&eradapter and the cable.

#heck if the &all outlet is alive.'o&er failure

@othing happens

Recommended Measures'robable #auses;ymptoms

;ymptoms users can take corrective measures

Tr o u 2 l e

Re/. 14 E.14.1



;ymptoms 'robable #auses RecommendedMeasures

Message7Arror ()8(/C

Technical problem &iththe Test "evice

Retest using freshsample or device.

Message7Arror ; or ;(C %ptical failure #all customer service.

Message72alue Arror -*C

>nusual sample orincorrect storage ofreagents

Retest using freshsample or device.

Message7

#aution ArrorC orArrorC

Technical problem &iththe Test "evice

Replace the Test

"evice &ith a ne& oneand repeat the test.

Message7#aution BarcodeArrorC Test "evice alignment is

off.

Remove the Test"evice and try again.Repeat &ith a ne& Test"evice .

#all customer service.Message7ot @umber ArrorC

Message7I" #hip ot @umber MismatchC

"oes not match the Test"evice lot J &ith I" #hipJ

#heck the Test "evicelot J and I" #hip J.

Message7I" #hip #artridgeMismatchC

"oes not match the Test"evice Item &ith I" #hipItem

#heck the Test "eviceItem and I" #hip Item.

Message7Insert I" #hipC @o I" #hip Insert I" #hip onto

the instrument.

Message7$b o&C

$b conc. of the sample is belo& ).* g3d

Retest the sample andmake sure that acorrect volume ofdetector is applied.

Message7$b $ighC

$b conc. of the sample isabove ().* g3d.

The volume of detector istoo small

Retest the sample andmake sure that acorrect volume ofdetector is applied.

Tr o u 2l e

! 3 o o t i n *

IChroma Operation Manual

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