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
Quick Manual for TEST MODE
I
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 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
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
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
Rev. 10
 Cartridge
1
 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
V
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
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
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 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.
Function Keys
The “cursor” in these descriptions stands for the “>>” notation.
Down
Up
Reset
Operation
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 i-CH
ROMATM Reader with a System Control Device.
Operation
On-Screen displays and applicable steps
MENU
22D
13:13:00
* Test Mode
Setting Mode
 When you turn power switch on, you will
see ”MENU” on–Screen 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
Insert a System Control Device into the holder
VII
after a sample loading .
System Check
Reading
Progressing
System Check
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.
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
VII
The following steps describe recommended procedures for a test in i-CH
ROMATM 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
MENU
22D
13:13:00
* Test Mode
Setting Mode
 When you turn power switch on, you will
see ”MENU” on–Screen 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
Insert a Test Device into the holder after a sample
VII
loading .
Operation
 Press “Select” key to start.
hsCRP Test
Reaction
Progressing
05 : 00
hsCRP Test
Reading
Progressing
OO %
hsCRP Test
 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.
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
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
PRE * RESET
NEXT * SELECT
year. month. day
hour : min
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.
 “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.
 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.
“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.
A
B
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.
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
VIII
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 i-CHRO
MATM 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
User’s 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
X
Trouble
Shooting
Symptoms
E.10.2