Immunofluorometer Equipment

i-CHROMA

Reader

Operation Manual

TABLE OF CONTENTS
English

Quick Manuals

E.1

II

Introduction and Principle of Operation

E.2

III

Contents of System

E.3

IV

Specifications

E.4

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

Trouble Shooting

E.10

XI

Contact Information

E.11

Section I

I
Quick Manual

Quick Manual for TEST MODE

II

III

IV
Rev. 10

For finish a test,

press In/Out button to put the holder back
Power Switch OFF
E.1

II

Section II

Introduction

Introduction and Principle of

Operation
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 invitro 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.

Rev. 10

E.2.1

II

holder and does not require an external holder to place the Test
Device in. The Test Device holder will appear through the

Introduction

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

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.

Rev. 10

E.2.2

III

Section III
Contents of System
Unpacking

Contents

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

Contents
i-CHROMATM Reader set
i-CHROMATM Reader

Operation manual

Power cable for Reader

Connection cable

Printer set (Optional)

Thermal printer

Manual for printer

Printer paper (roll)

Pipette set (Optional)

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

Capillary tube (5ul)

System Check Chip set

Rev. 10

Cartridge

ID chip

1
E.3

Section IV
Specifications

IV

Physical Description
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

Specifications

Dimensions

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.

Rev. 10

E.4

Section V
Initial Installation Procedure
Power requirements

Reader
Installation

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.

Rev. 10

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.

E.5.1

4.

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

V
Reader
Installation

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.)
MENU
22D
13:13:00
* Test Mode
Setting Mode

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.
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).

Rev. 10

E.5.2

VI

Section VI
Printer Installation
i-CHROMATM Reader comes with an optional printerthatpreconfigured
to work. For proper handling and installation of the printer, refer to the

Printer
Installation

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.

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

VII

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

Function Keys
The cursor in these descriptions stands for the >> notation.

Down

Up

Reset

Operation

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

This function moves the cursor down a line on the display

window.

This function moves the cursor up a line on the display window.

This function returns the screen to the previous mode.

This function selects and executes the command at the cursor

Select

In/Out

Rev. 10

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.

E.7.1

Procedure for System Check

VII

The following steps describe recommended procedures for a test in iCHROMATM Reader with a System Control Device.

Operation

On-Screen displays and applicable steps

When you turn power switch on, you will
MENU
22D
13:13:00
* Test Mode
Setting Mode

see MENU onScreen after Self Test

Mode.
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
ID Chip

Rev. 10

Insert a System Check ID chip.

E.7.2

Insert Control
Cartridge
Select to Start

Prepare a System Control Device

And then, you should do a test

VII

Insert a System Control Device into the holder

after a sample loading .

System Check
Reading
Progressing

System Check
System OK

Operation

Press Select key to start.

i-CHROMATM Reader will scan the System

Control Device automatically.

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.

Rev. 10

E.7.3

Procedure for Test Mode

VII

The following steps describe recommended procedures for a test in iCHROMATM Reader with a specific Test Device. You can use only
whole blood for test (No serum or commercial controls)

Operation

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
MENU
22D
13:13:00
* Test Mode
Setting Mode

see MENU onScreen after Self Test

Mode.
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
ID Chip

Rev. 10

Insert a proper ID chip which you want to test.

E.7.4

Insert hsCRP
Cartridge
Select to Start

Prepare a Test Device and apply sample mixture

onto the Test Device.
And then, you should do a test

VII

Insert a Test Device into the holder after a sample

loading .
Operation

Press Select key to start.

hsCRP Test
Reaction
Progressing
05 : 00

hsCRP Test
Reading
Progressing
OO %

hsCRP Test
O.O mg/L

i-CHROMATM Reader will scan the Test Device

automatically after 3 min for immune reaction.

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.

Rev. 10

E.7.5

Procedure for Time Setting and

VII

Recall Previous Results

Operation

MENU
22D
13:13:00
Test Mode
* Setting Mode
MENU
22D
13:13:00
Recall Result
* Time Set
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.

PRE * RESET
NEXT * SELECT
year. 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.

hsCRP Test 01
00.0 mg/L
year. month. day 13:13

Print Data
* One
All
Rev. 10

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.

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.
Choose One mode for single result or All
mode for total data with Up or Down key
and then press Select key.
E.7.6

Caution in handling the cartridge

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

When inserting the Test Device into the holder, orient the Test
Device in such a way that the B well should be toward i-

Operation

VII

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.
Dont 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.

Rev. 10

E.7.7

Section VIII
Warnings, Precautions and Limitations
VIII

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

Warnings
Precautions
Limitations

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.
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.

Rev. 10

E.8

Section X
Trouble Shooting
Symptoms users can take corrective measures
Symptoms

Probable Causes

Recommended Measures

Power failure

Check if the wall outlet is alive.

Poor connection
between the power
adapter and the cable.

Remove the power cable (from

SMPS to i-CHROMATM
Reader) and reconnect firmly.

Main switch is off.

Turn on the main switch.

Faulty power adapter

Call customer service.

Excessive
computational load

Wait till the computation is

finished.

Computational
Abnormality

Turn the power off and on again.

Mechanical failure
(Buzzing noise)

Call customer service.

Software Abnormality

Turn off the power and start

fresh

Electrostatic shock

Ground the surface of iCHROMATM Reader to electric

ground terminal. Remove any source
of electric charge. Reset the system.

Electric circuit failure

Call customer service.

Clicking noise
when the holder
extends

Normal mechanical
setting

Users action is not required.

Message:
Error 21~24

Internal Electrical or
Mechanical Fault

Call customer service.

X
Nothing happens
Trouble
Shooting
Run finished and
no result
returned.

Sample holder
does not show.

Display does not

function
properly.

Rev. 10

E.10.1

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.

Test Device alignment is

off.

Remove the Test

Device and try again.
Repeat with a new Test
Device .

Message:
Caution Barcode
Error
Message:
Lot Number Error

Call customer service.

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.

Rev. 10

Trouble
Shooting

Symptoms

E.10.2