chroma manual 090120

8/3/2019 Chroma Manual 090120

http://slidepdf.com/reader/full/chroma-manual-090120 1/20

i-CHROMAT

M

mmunofluorometer Equipment

Reader

Operation Manual



I Quick Manuals E.1

II Introduction and Principle of Operation E.2

III Contents of System E.3

IV Specifications E.4

V Initial Installation Procedure E.5

VI Printer Installation E.6

VII Operation E.7

VIII Warnings, Precautions, and Limitations E.8

IX Service, Maintenance, and Disposal E.9

X Trouble Shooting E.10

XI Contact Information E.11

En gl i s h

TABLE OF CONTENTS



Section I

Q ui c k

M an u al

I

Rev. 10 E.1

For finish a test,

press “In/Out” button to put the holder back

Power Switch OFF

Quick Manual for TEST MODE

I

II

III

IV



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 excitation 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

examination.

After a buffer-mixed sample is applied to the Test Device, the Test Device is

inserted into i-CHROMA Reader and the concentration of analyte is

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

can accept Test Devices that are designed specifically for use with this

instrument.

Section II

Introduction and Principle of OperationI nt rod ct i on

II

Rev. 10 E.2.1



i -CHROMATM Reader is equipped with a built-in Test Device

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

Device in. The Test Device holder will appear through the

opening on the front surface of the Reader.

The main power switch, located on the left side of the instrument,

powers the i -CHROMATM

Reader. The optional printer comes

with its own power supply. These two power supplies have

different power ratings, and a critical damage on instrument can

thus be resulted in if power supplies are connected incorrectly.

Power supplies are labeled, indicating that which unit are

supposed to work with.

I n t r o d u c t i on

II

Rev. 10 E.2.2



Section III

Contents of System

Unpacking

After opening the box, compare the contents with the list below.

Contents i -CHROMATM Reader set

i -CHROMATM Reader 1

Operation manual 1

Power cable for Reader 1

Connection cable 1

Printer set (Optional)

Thermal printer 1

Manual for printer 1

Printer paper (roll) 1

Pipette set (Optional)

Pipette (10, 20, 30, 75, 100ul) 1

Capillary tube (5ul) 1

System Check Chip set

Cartridge 1

ID chip 1

Cont ent s

III

Rev. 10 E.3



Physical Description

Dimensions 250 (L) x 185 (W) x 80 (H) mm Weight 2 kg

Power supply 100-240V AC, 50/60Hz, 0.5-1.3A

Data output: On-board screen / Printer

Environmental Set-up

Temperature 15oC ~30oC

Humidity 10 ~ 80%

Location Dry, clean, flat, horizontal surface away from

direct sunlight and mechanical vibration.

Optical Description

Light source Laser diode, 2.5 mW, 637nm

Detector Silicon photo diode

Other

Driver Motor 12V

Interface RS-232 serial (I/O) port

Printer Thermal

Display LCD (16x4 character)

Key pad 5 function keys

*** This device meets the EMI guideline as per EN60601-1-2.

Section IV

Specifications

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

IV

Rev. 10 E.4



4. Turn on the power switch on the left side of i -CHROMATM Reader.

5. i -CHROMATM Reader will execute a series of self-checking routine.

Upon successful completion, the display monitor will show the initial

screen as shown below. (The actual contents of the display could be differ,

depending on the specification and customer requirements.)

Caution: Keep the cables, cords and wirings for the power adapter and

the printer away the front and the top surface of i -CHROMATM

Reader. These could render it hazardous to connect/disconnect the

power adapter (and the printer).

6. i -CHROMATM Reader is now ready for use.

7. At the end of the run, remove the Test Device from i -CHROMATM

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

the power off.

M E N U 22D13:13:00

* Test Mode

Setting Mode

R e a d er

I n s t al l a t i on

V

Rev. 10 E.5.2



ection VI

rinter Installation

i -CHROMATM Reader comes with an optional printer that preconfigured to

work. For proper handling and installation of the printer, refer to the

instruction manual accompanying the printer. With the printer ready for

operation, you can connect the printer to i -CHROMATM Reader following

steps listed below.

1. Connect the other of the cable to i -CHROMATM Reader.

2. Now the printer is ready for operation.

3. Turn on the power switch on the left side of Printer.

P r i n t e r

VI

Rev. 10 E.6



Section VII

Operation

The operation of i -CHROMATM Reader is performed by five primary

functions each of which can be represented by corresponding key pad on thefront panel. The software in i -CHROMATM Reader is designed concisely

and user-friendly to be used in a point-of-care or a central laboratory setting.

Each of these functions is addressed in this section.

Function Keys

The “cursor” in these descriptions stands for the “>>” notation.

This function selects and executes 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 run: the sample holder stays extended 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 window.

This function moves the cursor down a line on the display

window.

O p e r a t i on

VI

Rev. 10 E.7.1

Down

Up

Reset

Select

In/Out



Procedure for System Check

The following steps describe recommended procedures for a test in i -

CHROMATM Reader with a System Control Device.

On-Screen displays and applicable steps

When you turn power switch on, you will

see ”MENU” on–Screen after “Self Test

Mode”.

Insert

ID Chip

Choose “Test mode” by moving cursor with

“Up” or “Down” key. Press “Select” key to move

next stage after you chose a specific mode.

“Insert ID Chip” is displayed on the screen.

Insert a System Check ID chip.

Ope r at i on

VII

M E N U 22D

13:13:00

* Test Mode

Setting Mode

Rev. 10 E.7.2



ystem Check

Reading

Progressing

i -CHROMATM Reader will scan the System

Control Device automatically.

Prepare a System Control Device

And then, you should do a test

Insert a System Control Device into the holder

after a sample loading .

Press “Select” key to start.

Insert Control

Cartridge

Select to Start

System Check

System OK

The test result will show up on-screen. You can

also get the print-out of test result.

If you press “Reset” button, Screen will return to

“MENU” mode. Now you can run another test.

O p e r a t i on

V

Rev. 10 E.7.3



Procedure for Test Mode

The following steps describe recommended procedures for a test in i -

CHROMATM Reader with a specific Test Device. You can use onlywhole blood for test (No 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-Screen displays and applicable steps

When you turn power switch on, you will

see ”MENU” on–Screen after “Self Test

Mode”.

Insert

ID Chip

Choose “Test mode” by moving cursor with

“Up” or “Down” key. Press “Select” key to move

next stage after you chose a specific mode.

“Insert ID Chip” is displayed on the screen.

Insert a proper ID chip which you want to test.

Ope r at i on

VII

M E N U 22D

13:13:00

* Test Mode

Setting Mode

Rev. 10 E.7.4



sCRP Test

Reading

Progressing

OO %

i -CHROMATM Reader will scan the Test Device

automatically after 3 min for immune reaction.

Prepare a Test Device and apply sample mixture

onto the Test Device.

And then, you should do a testInsert a Test Device into the holder after a sample

loading .

Press “Select” key to start.

Insert hsCRP

Cartridge

Select to Start

hsCRP Test

O.O mg/L

The test result will show up on-screen. You can

also get the print-out of test result.

If you press “Reset” button, Screen will return to

“MENU” mode. Now you can run another test.

O p e r a t i on

V

sCRP TestReaction

Progressing

05 : 00

Rev. 10 E.7.5



MENU * SELECT

SET * RESET

year. month. day

hour : min

“Time Set” mode is for date/time setting only

when you activate the instrument for the first time

or reuse after not using the instrument more than a

month. After pressing “Reset” key, you can set year

blinking with “Up” or “Down” key.

Procedure for Time Setting and Recall

Previous Results

Choose “Setting Mode” and “Time Set” or

“Recall Result” by moving cursor with “Up” or

“Down” key. Press “Select” key to move next stage

after you chose a specific mode.MENU 22D

13:13:00

Recall Result

* Time Set

PRE * RESET

NEXT * SELECT

year. month. day

hour : min

Use “Select” key to move year to month to dateto time while setting month/date/time with “Up”

or “Down” key. Press “Select” key to go back to

Menu mode when you finish setting date/time.

Ope r at i on

VII MENU 22D

13:13:00

Test Mode

* Setting Mode

hsCRP Test 01

00.0 mg/L

year. month. day 13:13

“Recall Result” mode is used to store and recall

previous tests. You can store up to 100 test results

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

with “Up” or “Down” key. For printing the

previous results, press “Select” key.

Print Data

* OneAll

Choose “One” mode for single result or “All”

mode for total data with “Up” or “Down” key and

then press “Select” key.

Rev. 10 E.7.6



The test sample should be applied to the “B” well, as shown below.

Caution in handling the cartridge

• When inserting the Test Device into the holder, orient the Test

Device in such a way that the “B” well should be toward i -

CHROMATM Reader. This direction is also marked with an arrow

on the Test Device .

• Push the Test Device all the way into the holder until the Test Device

comes to a stop. Use only the push of your thumb or the index finger.

Don’t use of excessive force on the Test Device, or it will result in a

mechanical failure.

• The spent Test Device should be treated as a potential bio-hazard and

should be disposed of according to the standing ordinance. We

recommend high temperature autoclaving, followed by incineration.

A

B

A B

O p e r a t i on

VI

Rev. 10 E.7.7



Do not insert anything other than a Test Device provided by themanufacturer into the sample holder.

Do not immerse i -CHROMATM Reader into water.

Do not spill any liquid on i -CHROMATM Reader. This may disable the

system.

Do not drop i -CHROMATM Reader.

Do not subject i-CHROMA to mechanical shocks heavier than light taps

with hands.

Do not open i -CHROMATM Reader without written authorization from

its representative.

Do not place heavy objects on i -CHROMATM Reader. This may damage

the optical alignment to result in degraded performance or in mechanical

damage.

Use only the power adapter provided with i -CHROMATM Reader.

Use i -CHROMATM Reader only in environment as specified in section

IV .

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

interpreted by trained medical personnel only.

Section VIII

Warnings, Precautions and Limitations

Cautions should be taken to use i -CHROMATM Reader in settings

meeting the requirements specified in Section IV of this manual and in

observance of the warnings in Section VIII . If used otherwise, the

built-in safety features of i -CHROMATM Reader may be compromised

to present severe electrical, mechanical or biological hazards to the

user.

W ar ni n g s

P r e c aut i ons

VIII

Rev. 10 E.8



Section X

Trouble Shooting

Call customer service.Internal Electrical or Mechanical Fault

Message:“Error 21~24”

User’s action is not required. Normal mechanicalsetting

Clicking noisewhen the holder extends

Call customer service.Electric circuit failure

Ground the surface of i -CHROMATM Reader to electricground terminal. Remove anysource of electric charge. Resetthe system.

Electrostatic shock Display does notfunction properly.

Turn off the power and startfresh

Software Abnormality

Call customer service.Mechanical failure(Buzzing noise)Sample holder

does not show.

Turn the power off and on again.ComputationalAbnormality

Wait till the computation isfinished.

Excessivecomputational loadRun finished and

no resultreturned.

Call customer service.Faulty power adapter

Turn on the main switch.Main switch is off.

Remove the power cable (fromSMPS to i -CHROMATM Reader) and reconnect firmly.

Poor connection between the power adapter and the cable.

Check if the wall outlet is alive.Power failure

Nothing happens

Recommended MeasuresProbable CausesSymptoms

Symptoms users can take corrective measures

Tr o u b l e

X

Rev. 10 E.10.1



Symptoms Probable Causes Recommended Measures

Message:

“Error 25~28”

Technical problem with the

Test Device

Retest using fresh sample

or device.

Message:“Error S1 or S2”

Optical failure Call customer service.

Message:“Value Error 1-10”

Unusual sample or incorrectstorage of reagents

Retest using fresh sampleor device.

Message:“Caution Error” or

“Error”

Technical problem with theTest Device

Replace the Test Devicewith a new one and repeat

the test.

Message:“Caution BarcodeError”

Test Device alignment is off. Remove the Test Deviceand try again. Repeatwith a new Test Device .

Call customer service.Message:“Lot Number Error”

Message:

“ID Chip Lot Number Mismatch”

Does not match the Test

Device lot # with ID Chip #

Check the Test Device lot

# and ID Chip #.

Message:“ID Chip CartridgeMismatch”

Does not match the TestDevice Item with ID ChipItem

Check the Test DeviceItem and ID Chip Item.

Message:“Insert ID Chip”

No ID Chip Insert ID Chip onto theinstrument.

Message:“Hb Low”

Hb conc. of the sample is below 5.0 g/dL

Retest the sample andmake sure that a correctvolume of detector isapplied.

Message:“Hb High”

Hb conc. of the sample isabove 25.0 g/dL.The volume of detector is toosmall

Retest the sample andmake sure that a correctvolume of detector isapplied.

Tr o u bl e

S h o o t i n g

X

chroma manual 090120

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