Immunofluorometer Equipment

TM
i-CHROMA
Reader

Operation Manual
TABLE OF CONTENTS

English
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

 Section I
I
Quick Manual for TEST MODE

Quick Manual
I

II

III

For finish a test,

IV press “In/Out” button to put the holder back
Power Switch OFF

Rev. 10 E.1
 Section II
II
Introduction and Principle of Operation
Introduction

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.

Rev. 10 E.2.1
 II

Introduction
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.

Rev. 10 E.2.2
 Section III
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 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
Rev. 10 E.3
 Section IV
Specifications IV
Physical Description

Specifications
 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.

Rev. 10 E.4
 Section V
Initial Installation Procedure
V
Power requirements
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,
Reader

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.

Rev. 10 E.5.1
 4. Turn on the power switch on the left side of i-CHROMATM Reader.
V

Installation
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.)

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

instruction manual accompanying the printer. With the printer ready for
Printer

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 the
front panel. The software in i-CHROMATM Reader is designed concisely
VII
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.

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

This function moves the cursor down a line on the display

Down
window.

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

Up

This function returns the screen to the previous mode.

Reset

This function selects and executes the command at the cursor

Select
position

This function moves the sample carrier in and out of the main
In/Out 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.

Rev. 10 E.7.1
 Procedure for System Check
The following steps describe recommended procedures for a test in i-CH
VII ROMATM Reader with a System Control Device.
Operation

On-Screen displays and applicable steps

 When you turn power switch on, you will
MENU 22D see ”MENU” on–Screen after “Self Test
13:13:00
* Test Mode Mode”.
Setting 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  Insert a System Check ID chip.

Rev. 10 E.7.2
  Prepare a System Control Device
Insert Control
Cartridge And then, you should do a test
Select to Start Insert a System Control Device into the holder
VII
after a sample loading .
 Press “Select” key to start.

Operation
System Check  i-CHROMATM Reader will scan the System
Reading
Progressing
Control Device automatically.

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

System Check
also get the print-out of test result.
System OK
 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
The following steps describe recommended procedures for a test in i-CH
VII ROMATM 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
Operation

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 see ”MENU” on–Screen after “Self Test
13:13:00
* Test Mode Mode”.
Setting 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  Insert a proper ID chip which you want to test.

Rev. 10 E.7.4
  Prepare a Test Device and apply sample mixture
Insert hsCRP
Cartridge onto the Test Device.
 And then, you should do a test
Select to Start VII
Insert a Test Device into the holder after a sample
loading .
 Press “Select” key to start.

Operation
hsCRP Test
Reaction
Progressing
05 : 00

hsCRP Test  i-CHROMATM Reader will scan the Test Device

Reading
Progressing
automatically after 3 min for immune reaction.
OO %

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

hsCRP Test
also get the print-out of test result.
O.O mg/L
 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
Recall Previous Results
VII MENU 22D
13:13:00
Test Mode Choose “Setting Mode” and “Time Set” or
* Setting Mode “Recall Result” by moving cursor with “Up” or
Operation

MENU 22D
“Down” key. Press “Select” key to move next stage
13:13:00 after you chose a specific mode.
Recall Result
* Time Set

MENU * SELECT  “Time Set” mode is for date/time setting only

SET * RESET when you activate the instrument for the first time
year. month. day or reuse after not using the instrument more than a
hour : min month. After pressing “Reset” key, you can set year
blinking with “Up” or “Down” key.
 Use “Select” key to move year to month to date
PRE * RESET
NEXT * SELECT to time while setting month/date/time with “Up”
year. month. day or “Down” key. Press “Select” key to go back to
hour : min Menu mode when you finish setting date/time.

“Recall Result” mode is used to store and recall

hsCRP Test 01
previous tests. You can store up to 100 test results
00.0 mg/L
year. month. day 13:13 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  Choose “One” mode for single result or “All”
mode for total data with “Up” or “Down” key and
* One
All then press “Select” key.

Rev. 10 E.7.6
 Caution in handling the cartridge
• The test sample should be applied to the “B” well, as shown below.
VII
A B

Operation
• 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.

Rev. 10 E.7.7
 Section VIII
Warnings, Precautions and Limitations

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

manufacturer into the sample holder.
VIII
 Do not immerse i-CHROMATM Reader into water.
 Do not spill any liquid on i-CHROMATM Reader. This may disable the
Precautions
Limitations

system.
Warnings

 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.

X Poor connection Remove the power cable (from
between the power SMPS to i-CHROMATM
Nothing happens adapter and the cable. Reader) and reconnect firmly.
Main switch is off. Turn on the main switch.
Shooting
Trouble

Faulty power adapter Call customer service.

Excessive Wait till the computation is
Run finished and computational load finished.
no result
returned. Computational Turn the power off and on again.
Abnormality
Mechanical failure Call customer service.
Sample holder (Buzzing noise)
does not show. Turn off the power and start
Software Abnormality fresh
Ground the surface of i-CHRO
Electrostatic shock MATM Reader to electric ground
Display does not terminal. Remove any source of
function properly. electric charge. Reset the system.

Electric circuit failure Call customer service.

Clicking noise Normal mechanical

when the holder setting User’s action is not required.
extends
Message: Internal Electrical or Call customer service.
“Error 21~24” Mechanical Fault

Rev. 10 E.10.1
 Symptoms Probable Causes Recommended
Measures
Message: Technical problem with the Retest using fresh
“Error 25~28” Test Device sample or device.
Message: Optical failure Call customer service.
“Error S1 or S2”
Unusual sample or X
Message: incorrect storage of Retest using fresh
“Value Error 1-10” reagents sample or device.

Message: Technical problem with the Replace the Test

“Caution Error” or Device with a new one

Shooting
Test Device

Trouble
“Error” and repeat the test.
Message: Remove the Test
“Caution Barcode Device and try again.
Error” Test Device alignment is Repeat with a new Test
off. Device .
Message:
“Lot Number Error” Call customer service.
Message: Does not match the Test Check the Test Device
“ID Chip Lot Device lot # with ID Chip lot # and ID Chip #.
Number Mismatch” #
Message: Does not match the Test Check the Test Device
“ID Chip Cartridge Device Item with ID Chip Item and ID Chip Item.
Mismatch” Item

Message: No ID Chip Insert ID Chip onto

“Insert ID Chip” the instrument.

Retest the sample and

Message: Hb conc. of the sample is make sure that a
“Hb Low” below 5.0 g/dL correct volume of
detector is applied.
Hb conc. of the sample is Retest the sample and
Message: above 25.0 g/dL. make sure that a
“Hb High” The volume of detector is correct volume of
too small detector is applied.

Rev. 10 E.10.2