i-CHROMAT

M

Immunofluorometer 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

glishTABLE OF CONTENTS

Section IQ

uick

Man

ual

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 Operation

Introd

uction

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.

Introd

uction

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

Con

tents

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

Sp

ecifications

IV

Rev. 10 E.4

Section V

Initial Installation Procedure

Power requirements

i-CHROMATM Reader will work on household power line, 110-120 V

or 220-240 V AC, 50 ~ 60Hz. If you are uncertain of your power line,

consult with your utility manager.

 Location

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

horizontal surface away from direct sunlight and other source of

electromagnetic radiation (power transformers for example).

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.

1. Place i-CHROMATM Reader on a flat table

(surface), with the front surface at least 10cm

inside of the table edge.

• Connect the power cord for i-CHROMATM

Reader to the wall power outlet.

• Connect the power connector to i-CHROMATM

Reader.

Read

er

Installation

V

Rev. 10 E.5.1

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 22D 13:13:00

* Test Mode Setting Mode

Read

er

Installation

V

Rev. 10 E.5.2

Section VI

Printer 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.

Prin

ter

Installation

VI

Rev. 10 E.6

Section VIIOperation

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

functions each of which can be represented by corresponding key pad on

the front 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.

Op

eration

VII

Rev. 10 E.7.1

Down

Up

Reset

Select

In/Out

Procedure for System CheckThe 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.

Op

eration

VII

M E N U 22D 13:13:00

* Test Mode Setting Mode

Rev. 10 E.7.2

System 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.

Op

eration

VII

Rev. 10 E.7.3

Procedure for Test ModeThe following steps describe recommended procedures for a test in i-

CHROMATM Reader with a specific Test Device. You can use only

whole 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.

Op

eration

VII

M E N U 22D 13:13:00

* Test Mode Setting Mode

Rev. 10 E.7.4

hsCRP 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 test

Insert 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.

Op

eration

VII

hsCRP Test Reaction 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 * SELECTyear. month. day hour : min

Use “Select” key to move year to month to date to 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.

Op

eration

VII MENU 22D 13:13:00

Test Mode * Setting Mode

hsCRP Test 0100.0 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 the test result by searching date and time of the test with “Up” or “Down” key. For printing the previous results, press “Select” key.

Print Data

* One All

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

Op

eration

VII

Rev. 10 E.7.7

Do not insert anything other than a Test Device provided by the

manufacturer 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.

Warn

ings

Precau

tions

Lim

itations

VIII

Rev. 10 E.8

Section XTrouble Shooting

Call customer service.Internal Electrical or Mechanical Fault

Message:“Error 21~24”

User’s action is not required.Normal mechanical setting

Clicking noise when the holder extends

Call customer service.Electric circuit failure

Ground the surface of i-CHROMATM Reader to electric ground terminal. Remove any source of electric charge. Reset the system.

Electrostatic shockDisplay does not function properly.

Turn off the power and start freshSoftware Abnormality

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

does not show.

Turn the power off and on again.Computational Abnormality

Wait till the computation is finished.

Excessive computational loadRun finished and

no result returned.

Call customer service.Faulty power adapter

Turn on the main switch.Main switch is off.

Remove the power cable (from SMPS 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

Trou

ble

Sh

ooting

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 incorrect storage of reagents

Retest using fresh sample or device.

Message:“Caution Error” or “Error”

Technical problem with the Test Device

Replace the Test Device with a new one and repeat the test.

Message:“Caution Barcode Error” Test Device alignment is

off.

Remove the Test Device and try again. Repeat with 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 Cartridge Mismatch”

Does not match the Test Device Item with ID Chip Item

Check the Test Device Item and ID Chip Item.

Message:“Insert ID Chip” No ID Chip Insert ID Chip onto

the instrument.

Message:“Hb Low”

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

Retest the sample and make sure that a correct volume of detector is applied.

Message:“Hb High”

Hb conc. of the sample is above 25.0 g/dL.The volume of detector is too small

Retest the sample and make sure that a correct volume of detector is applied.

Trou

ble

Sh

ooting

X

Rev. 10 E.10.2