Post on 31-Mar-2015
transcript
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