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Operation Guide
Operation Guide
MEK-1300 series
Table of contents
[1] Introduction
[2] Operation
[1] Introduction
This installation guide provides information about installation, calibration and quality control for a demonstration of
the MEK-1300 series hematology analyzer. Each item is listed in the actual order of operation. Install and operate
the analyzer according to this guide. For details about the analyzer, refer to the operator’s manual.
Installation takes approximately 2 hours.
This installation guide is for the following instruments of the MEK-1300 series.
MEK-1301 (CBC open measurement only type)
MEK-1302 (CBC both open & closed measurement type)
MEK-1305 (CBC+ESR open measurement only type)
CBC+ESR
◆ Power ON
Press the power switch
(*) Normally, when the power is turning ON, it performs “Self Check”, not the “Startup” process.
(1) The sub power indicator lights “green” (screen is not on yet). The screen comes on about 5 seconds after
turning ON.
[Caution]
Please note, if [Waste Sensor] is set to “On” even
though a waste sensor is not in use, the system
will detect the waste container is always full and
the instrument will stop operating.
4-2. Registering Reagents
◆ In order to get accurate results, it is important to use
reagents properly within their expiration dates. The
reagent management function makes it possible to
manage reagents by not only the lot, but also by opening
day or expiration after opening. It’s simply reading the
bar code attached to the reagent when replacing it.
◆ When the reagent management function is used and a
reagent gets low, instrument shows a warning message
in advance to replace the reagent. The approximate
amount of reagent remaining can also be checked via
the icon at the top of the screen.
◆ Each reagent has a lot number and expiration. When the
expiration is passed, the reagent cannot be used. Once
a reagent has been registered, it cannot be registered
again.
(*) If the barcode cannot be read for some reason, touch the [Manual Entry] key to open a dialog to enter the code.
Use the on-screen numeric keypad to enter the barcode number exactly. (This entry is case-sensitive.)
[Note]
Once the code of a reagent is registered, it cannot be registered again.
Once a reagent has expired, it cannot be registered.
If one of the reagents is not registered, the system cannot start to prime.
5. Setting the period of Protein Cleaning
◆ The “Protein cleaning” function cleans primarily the flow paths inside the analyzer with CLEANAC-3. Perform
“Protein cleaning” at least once a month to remove deposited blood protein inside of the analyzer. A message
of prompting “Protein Cleaning” is displayed after the number of measurements exceeds the limit.
By setting an approximate number of measurements done
per month, and “Protein cleaning” is performed once a
month, the state of the analyzer can be maintained.
[Note]
Perform “Protein cleaning” at least once a month.
Before starting “Protein cleaning”, make sure there is
enough remaining reagent and that the waste container
is not full.
[Note]
For using the calibrator (MEK-CAL), read the instruction manual. In particular, be sure to follow the instructions
about its expiration, expiration after opening and storage environment.
Expiration date Check the label on the container (lot every month)
Validity period 7 days after opening
Storage environment Store in a specified container at 2 to 8°C (35.6 to 46.4°F).
[Caution] Do not freeze.
Remove the calibrator from refrigerater and leave at room temperature for 15
minutes before use. After it returns to room temperature, mix it by inverting at
least 20 times so it is well-mixed for use.
The hematology controls MEK-3DN cannot be used as a calibrator. MEK-3DN is for quality control.
MEK-CAL cannot be used for calibrating WBC differential. Normally calibration coefficients for WBC differential
(LY% and MO%) are set 1,000, but they are only changed to correlate to eye counts.
◆ For MEK-1301 and MEK-1305, as only an open measurement is done, first calibrate with an open
measurement. Then calibrate the pre-dilution (capillary) measurement.
Calibration complete
◆ For MEK-1302, the calibration that forms the basis for others is done in the closed measurement, so first
calibrate in a closed measurement. Then calibrate the open measurement and the pre-dilution (capillary)
measurement.
Measure in
Closed measurement Open measurement
pre-dilution/capillary mode
Calibrate in
Calibration complete
pre-dilution/capillary mode*
Calibration complete
◆ Refer to the operation manual for details of pre-dilution and capillary measurement.
9-1. Calibrate Closed mode (CBC)
◆ For MEK-1302 Calibration method in the closed measure mode
(2) Check that the data has been entered correctly and
then touch [Next] to open the “Calibration
Measurement” screen. The tube holder opens
automatically.
(3) After blood aspiration is complete, the tube holder opens automatically. When
measurement is complete, the results data are updated to the calibration
measurement list.
(4) Continue to measure the calibrator 10 times. Before inserting the MEK-CAL to
the tube holder again, do inversion mixing again.
(5) The averages and CV values of measurement data are shown on the “Calibration
Measurement List” screen. Check the [CV] column and check whether there are
any large deviations in the measurement data. If there is a large deviations,
delete it and measure MEK-CAL again until total of 10 sets of data are available.
[Caution]
If the [Cancel] key is touched, all measurement data are deleted without saving it.
(6) When 10 sets of sample data are available, select the data that can be used for calibration. Touching the
check box to the left of data toggles between select and unselect.
(6)
(5)
(7)
(8)
(7) Check the content of data and select the parameter whose calibration coefficient is to be changed. Touching
a check box toggles between select and unselect. If the difference between the calculated value and the
calibration coefficient exceeds 20%, “Not Recommended” is shown and it cannot be changed; uncheck it and
touch “Edit” in the Calibration screen and enter it manually.
(9) On the Calibration screen, check whether the calibration coefficients are applied correctly.
9-2. Calibrate Open Mode (CBC)
◆ Calibration method in the open measure mode
After calibrating the closed mode (for MEK-1302), calibrate open mode (for all models).
(2) Check that the data has been entered correctly and
then touch [Next] to move the sampling nozzle to the
open measurement aspiration position and open the
“Calibration Measurement” screen.
3. Measure the MEK-CAL.
(1) Open the lid of the MEK-CAL and insert the tip of the
sampling nozzle to the lower part of the MEK-CAL, as Sampling Nozzle
[Note] During sample aspiration, do not lower the sample out of the sampling nozzle. A sound indicating
measurement in progress is made during sample aspiration.
[Caution]
If the [Cancel] key is touched, the measurement data is deleted without saving it.
(3) After measurement is complete, the measurement result data is updated to the calibration measurement list.
(4) Continue to measure the calibrator 10 times. Before measuring the MEK-CAL again, do inversion mixing
again.
(5) The averages and CV values of measurement data are shown on the “Calibration Measurement List” screen.
Check the [CV] column and check whether there are any large deviations in the measurement data. If there
is a large deviation, delete it and measure MEK-CAL again until a total of 10 sets of data are available.
(6) Calibrate following the same procedures as the calibration method (6) for closed measurement.
9-3. Calibrate Capillary Mode (CBC)
◆ Calibration method in the capillary measure mode
If the measurement data with pre-dilution and capillary modes do not match the calibration values with closed
mode results, calibrate them with the following method. Before calibration measurements with the pre-dilution or
capillary modes, prepare enough samples in advance on the Measurement screen.
1. Prepare samples
Set a capillary in the capillary adapter.
For YZ-0373K:
1) Load a capillary pipette into the groove in the assembler. Make sure that the end of the capillary pipette
touches the capillary assembler wall.
2) Attach the capillary adapter to the end of the capillary pipette. Fully insert the capillary pipette into the
adapter. After inserting, hold it by the adapter tab and handle so as to avoid damage.
For YZ-0373K
(2) Check that the data has been entered correctly and
then touch [Next] to open the “Calibration
Measurement” screen.
4. Sample blood.
Mix the MEK-CAL by inverting it at least 10 times, then open the cap and insert a capillary pipette so blood is
collected into it by capillary action.
[Reference] About collecting capillary blood
Collect the blood from a fingertip or heel with a lancet and the like, then aspirate blood into a capillary
tube with capillary action.
Measure within 1 minute after collection
with an EDTA coated capillary.
If the finger is squeezed hard to force
out blood, the body fluid will mix in, and
its result will be with measurement error.
For YZ-0373K
(1) Insert the tip of the sampling nozzle firmly into the capillary adapter so it is in close contact.
(2) Press the Measure switch by the opposite hand.
[Note] Insert the sampling nozzle in straight, so there is no gap between it and the adapter.
(3) After measurements are complete, the measurement result data is updated to the calibration measurement
list. Continue to measure the calibrator 10 times. Before measuring the MEK-CAL again, do inversion mixing
again.
(4) The averages and CV values of measurement data are shown on the “Calibration Measurement List” screen.
Check the [CV] column and whether there are any large deviations in the measurement data. If there is a
large deviation, delete it and measure MEK-CAL again until total of 10 sets of data are available.
(5) Calibrate following the same procedures as the calibration method (6) for closed measurement.
10. Measuring Background Noise (2)
◆ After performing calibration, measure the background again.
If “Quality Control at each login” setting is “On”, it becomes necessary to perform the quality control when
logging in from Administrator to Technical User, so in terms of convenience of maintenance, it is better to
leave the setting “Off”.
If the customer wants to use quality control method not only within the range of the assay sheet, but also “2D”
or “3D”, change settings of [Average/SD] or [Westgard Multi rules] to “On”.
To use X-R quality control method instead of L&J, login as “Technical User” and enter “ADV setting” screen in
the “System menu”. Set the quality control method to “X-R”.
2. Register controls.
Register the hematology control to be used before
measuring it. If the lot information of a hematology
control is not registered in the analyzer,
measurements are not saved as quality control
data.
(7) To switch between whether a blood control registered at one time should be subject to control or not, check
the check box of the lot to change and touch [Change Status] to toggle between enable and invalid.
Controls become automatically “Invalid” when they pass their expiration date.
3. Prepare the measurement mode and parameter set for control.
(1) On the “Measurement screen”, touch to focus the “Sample ID“ ( If only “Patient ID” is shown, then “Patient
ID” ), and Read the label of hematology control which is printed the lot number by handheld barcode reader.
The lot number will be entered into the “Sample ID” column. When the entered ID is already registered lot of
the control, It switches automatically to the QC mode.
(2) Check “[QC] Parameter Set” key on the “Measurement screen”. If the QC measurement method is not
correct, select the Parameter Set to measure the hematology control.
12. Check Data with a Hematology Control
◆ Measure a hematology control (MEK-3DN) to check the data.
Tube Type
(2) Leave at room temperature for 15 minutes so it returns to a normal temperature before use. After it returns to
normal temperature, mix it by inverting at least 20 times so it is well-mixed for use
[Caution]
Allow the hematology control to return to room temperature and then mix by inverting it. If mixed by
inverting before returning to room temperature, the contents may ooze out from the top of the cap.
For MEK-1301 and MEK-1305
(1) On the “Measurement screen”, If there is one ID (“Sample ID”
or “Patient ID”), read the hematology control label which is
printed the lot number by handheld barcode reader. Otherwise,
touch to focus the ID column to entry, and read the barcode.
The lot number is automatically entered into the ID column. If
the entered ID is already registered lot of the control, it
changes automatically to the “QC Parameters Set” which is
registered at system settings of “QC Parameters Settings“.
(3) Insert the end of the sampling nozzle into the sample tube until it
is just below the bottom of the side wall of the tube, as shown in the figure on
the right.
(4) Press the Measure key switch to start measurements. After the Measure key is pressed, the analyzer
aspirates the blood sample and measures it.
(5) The measurement results are automatically displayed when measurements end.
For MEK-1302 (Closed mode)
(3) Touch [Eject] key at bottom left to open the tube holder
(4) Set the hematology control into the tube holder, and Close the
tube holder. After that, the measurement starts automatically.
(6) The measurement results are automatically displayed when measurements end.