ECL 412 Đông Máu
ECL 412 Đông Máu
Preface
The ECL 412 User Manual is protected by copyright. Neither the whole nor any part of the
information contained herein may be adapted or reproduced in any material for, except with the
prior written consent of Erba Lachema.
All information, of a technical nature, and particulars of the ECL 412 Analyzer and its use are given
by Erba Lachema in good faith, but may contain errors. This manual is intended only to assist the
user in the use of the ECL 412 Analyzer and therefore Erba Lachema shall not be liable for any loss
or damage whatever arising from the use or any information or particulars in, or any errors, or
omission in this manual.
Users must respect the precautions and notes intended to protect them against injuries and/or
instrument damage.
Misuse of the instrument and none respect of the instrument maintenance procedures will void
the warranty.
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Revisions
Revision History:
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Icons
The following icons are used on the instrument to aid the user:
Storage
Store this instrument at between 5°C and 20 °C
Conditions:
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health, which could otherwise be caused by inappropriate
waste handling of this product. Please contact your local city
office or your distributor of this product. Pursuant to the EU
directive 2002/96/EC
- for medical devices sold from that time by ERBA Lachema
the corresponding costs are divided up as described
below:
1. The concerned device delivery to ERBA Lachema will
be paid by the CUSTOMER
2. Device dismantling sorting of parts and elimination of
wastes will be supported by ERBA Lachema according
to the existing local regulation
3. In case of a sale to a third-party the first CUSTOMER
shall inform ERBA Lachema of the name and address
of the new owner to guarantee the device traceability
and to allow it's further elimination, and shall inform
of the new owner that he will pay for the delivery of
the device to ERBA Lachema for its elimination
4. Otherwise the first CUSTOMER will pay all of the costs
and all penalties that the legal authorities should
impose on the manufacturer for default of the device
elimination traceability as requested by the
regulation
- For medical devices sold before that time, except in
particular cases, the elimination of the device will be
supported by the CUSTOMER. Upon request ERBA
Lachema could provide this elimination. Contact us for
quotation
- For medical devices sold and used in other countries, the
CUSTOMER should contact the ERBA Lachema
REPRESENTATIVE to be informed of his responsibilities
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The following iconography is used throughout this manual to help the user:
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1. Contents
1
PREFACE ________________________________________________________________________ 3
REVISIONS _______________________________________________________________________ 4
ICONS __________________________________________________________________________ 5
1. CONTENTS ___________________________________________________________________ 8
2. OVERVIEW __________________________________________________________________ 12
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5.7.1. GLOBAL __________________________________________________________________ 64
5.7.2. RUNNING MENU ____________________________________________________________ 65
5.7.3. PRINTER __________________________________________________________________ 67
5.7.4. LIS______________________________________________________________________ 68
5.7.5. SERVICE __________________________________________________________________ 69
6. INSTALLATION _______________________________________________________________ 71
7. MAINTENANCE ______________________________________________________________ 76
8. TROUBLESHOOTING __________________________________________________________ 79
9. PERFORMANCE ______________________________________________________________ 83
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2. Overview
2
Warning: if the equipment is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired
Screening tests:
PT 50µl 1 100µl
TT 100µl 1 50µl
Factors:
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D-Dimer
Others
Tests principles:
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See Chapter 3 for details of operating principles.
Dimensions / Weight:
Environmental requirements:
Power:
Calibrations:
Quality Controls:
Stored results:
o Independent storage allocation in the instrument memory for Quality Control (QC) and
patient determinations
o Up to 600 results for QC determinations (run in duplicate)
o Up to 900 results for patients (run in duplicate)
o New results automatically replace the oldest results of the appropriate category past the
maximum storage allowance
o Reaction curves are exclusively stored on the external USB pendrive.
o Regular backup and file purging is recommended from the USB pendrive to insure rapid
operations. (We recommend at least a monthly purge from a computer to back up and
remove CH files).
o Should a reformatting of the USB pendrive be needed, perform as FAT32
For additional information about the hardware, refer to 2.4 Device presentation
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Figure 3: ECL 412 rear view
The display is a 7 inches capacitive colour touch screen. The user can activate the functions by
clicking directly on the screen area directed by the graphical User Interface with finger and/or a
stylus or a clean pipette tip.
The device is a 2 inches integrated thermal printer. It prints automatically and/or on demand
results and other information.
This area includes the Measuring channels, the reaction cuvettes incubation area and the 37°C
reagent incubation area. It is made of an aluminium block, heated at 37+/-0.5°C and controlled by
several temperature sensors.
This area is composed of 20 positions (4 columns of 5 cuvette holes, aligned with the
measurement channels). It can hold the reaction cuvettes.
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1 position for a 30 mm diameter vial (or 22 to 24 mm diameter with adaptor). This position
is equipped with a stirring device.
4 positions for 3 ml cups for reagent incubations
The 2 reagent vial positions are equipped with a stirring device that create a rotating magnetic field
which moves a magnetic rod placed into the vial. This mechanism can be activated and deactivated
from the System (running mode) section of the software. This activation / deactivation is common
for the 37°C and ambient reagent positions.
The ECL 412 is equipped with a RFID antenna and reader that will be able to detect the reaction
cuvette stock to allow the system to perform the given number of tests. Past this consumption the
system will be blocked and will prompt for cuvette supply.
2.4.9. Interface
At the back and on the side of the ECL 412 a number of connections and buttons are present.
The ECL 412 analyzer is powered by an external power supply of 100 to 250V and about 47 to
63Hz Input, and Output of 7.5V DC 6A.
The system should only be operated using its original power supply. The use of any other
power supply cannot guarantee correct performance (temperature control and
measurements). It can as well cause interference and lead to malfunction and damage to the
instrument.
The Serial port is a RS232 9 pin connector for serial communication to the LIS.
2 master USB ports are present, one on the left side of the
instrument and one in the back.
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curves, which can be viewed when checking details in the Results.
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Figure 4: ECL 412 identification label for India (a), for the rest of the world (b)
Item Quantities
Stylus 1
USB Pendrive 1
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3. Operating Principles
3
The ECL 412 uses optical detection for 3 types of analyses:
The light emitted at 640nm by a LED is directed towards the reaction cuvette and the scattered
light intensity is measured at a 90° angle by a photo detector. It is weak at the beginning of the
reaction which starts immediately at the addition of the starter (the last reagent to be added), it
then increases gradually as the clot formation takes place and reaches a steady value once the clot
is fully formed. The algorithm that monitors the scattered light intensity in real time stops the
measurement when the measurement becomes stable.
Different algorithms can be applied to best fit the type of reaction seen with the different
parameters. The clotting time is then determined from the measured reaction curve.
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reaction to the end. Using a calibration curve with known concentrations, the patient sample is
calculated in the calibrators’ unit.
This measurement method is intended for immunologic reactions using latex based reagents that
are compatible with 800nm wavelength, typically D-Dimer. During these reactions, an immune
complex antigen-antibody will form and create optical turbidity which will decrease the light
intensity captured by the photo detector. This change in light intensity transformed in delta OD is
proportional to the concentration of the tested analyte present in the analysed sample.
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4.
4
Analyses preparations
Before running analyses, it is important to prepare everything. This includes:
The instrument
The samples
The reagents
2. Turn ON the instrument, using the ON switch to the I position in the back of the analyser
3. Let it warm up (you can monitor the temperature of the incubators on the main window,
see Software instructions for more details).
Note: the heating block takes from 10 to 20 minutes to equilibrate to 37+/-0.5 °C from the
time of switch ON (depending on the room temperature from 17 to 32°C ambient
temperature range).
In order to be able to run tests, the instrument needs to have loaded cuvettes in the system. Each
time a test is run, the supplies are subtracted, once the supply will expire, the system will display a
message: No more test available.
To load new supply (cuvettes), refer to 5.7.2 (System, Running Mode, RFID)
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Only centrifugated citrated plasmas should be used for testing on the ECL 412.
Plastic or siliconised glass should be used throughout the preparation of the samples.
Blood (9 parts) should be collected into 3.2% or 3.8% sodium citrate anticoagulant (1 part).
Separate plasma after centrifugation for 15 minutes at 1500 x g or for 10 minutes at 2500 x g.
Plasma should be kept between +2 and +8°C or +18 and +24°C depending on the assay(s) to be
performed.
Testing should be completed within the specified time frame from sample collection described in
the reagent technical inserts, otherwise plasma can be stored frozen at -20°C or -70°C for specific
durations also stated in technical inserts.
In case of frozen plasma, thaw quickly at +37°C prior to testing. Do not keep at +37°C for more than
5 minutes. This will minimize the neutralization of the lupus inhibitor.
Erroneous results may be caused by contamination with tissue fluids or stasis. Avoid agitation, air
bubbles or foaming. For the effects of commonly administered drugs, refer to Young, et al.
Visual inspections of the samples throughout its pre-analytical phase is also important. Hemolyzed
samples, presence of micro clots, samples that have been exposed to temperatures outside of the
recommended range may lead to inconsistent and erroneous results.
WARNING: Biohazard: As usual, consider all human-source materials, like controls and
calibrators, as potentially infectious. Observe appropriate precautions when using this
instrument, handling sample material or clinical waste; use laboratory coat, gloves, protective
eye wear.
Note: the volume of sample (or diluted sample) to be injected for each assay is reminded to the
user when selecting the analysis mode upon the selection of the assay. Refer to 5.4 Running
analysis and the icon
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4.3.2. Specific sample preparation
Immediately before running a given sample, prepare it as required. You can refer to the table below
as guidelines.
Parameter Reagents to be used Sample consumption/Test Consumption for duplicate tests for
dilutions
PT PT Reagent 50 µL
APTT APTT Reagent + Calcium 50 µL
Chloride
Fbg Owren's Veronal Buffer and 20 µL : 30 µL
Thrombin Reagent 180µl of buffer +20µl of sample 270µl of buffer + 30µl of sample
TT Thrombin Time Reagent 100 µL
Extrinsic Owren's Veronal Buffer + 20 µL : 20 µL :
Factor Factor-deficient Plasma + 80µl of buffer +20µl of sample 80µl of buffer +20µl of sample
PT based PT Reagent
Intrinsic Owren's Veronal Buffer + 20 µL : 20 µL :
Factor Factor-deficient Plasma + 80µl of buffer +20µl of sample 80µl of buffer +20µl of sample
APTT APTT Reagent + Calcium
based Chloride
DDimer DDimer Buffer + Latex 15 µL
AT III
Prot C
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Parameter Reagent Consumption/Test Consumption for duplicate tests for
dilutions
Prot S Diluent 90 µL 90 µL
90µl of diluent + 10µl of sample 90µl of diluent + 10µl of sample
Prot S R1 30 µL
Prot S R2 30 µL
Prot S R3 30 µL
Prot S R4 30 µL
Lupus Lupus screen 75 µL
DRVVT
Screen
Lupus Lupus confirm 75 µL
DRVVT
Confirm
Review instructions for preparation of reagents on the respective Instructions for Use present
in each kit.
Note: to pipette the reagents as well as prepare and inject the samples / sample dilutions it is
necessary to possess frequently calibrated automatic pipettes that can inject:
Volumes from 5 to 20µl for sample dilution preparation and low volume sample injections
Volumes of 50 to 200µl for the sample and reagent injections
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Read First: It is recommended that this section be read prior to further operation of the system.
Failure to follow recommendations can lead to reduced system protection for results as well as
user safety.
The start-up screen is the screen that appears upon switching the instrument ON after the initial
self-testing is completed.
This screen displays the Erba Mannheim ECL 412 logo that will disappear once any function is
selected.
From this screen all parts of the software are directly accessible thanks to a Top bar that consists of
all the menu buttons.
The Top Bar is always visible, regardless of the location in the software.
The Analysis button opens the window where testing can be performed.
DEFAULT / SELECTED /
FORMA
BUTTON ACTIVE INACTIVE DESCRIPTION / USE
T
STATUS STATUS
Analysis
Window
Where analyses can be carried out. Button
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5.1.4. Results button
The Results button opens the Results Window which allows for the detailed review of data
collected by the system with regards to patient sample, Control and Calibrator sample results. This
includes results (in all units applicable for the method), reaction curves (if USB key was/is
connected to instrument) and alarms.
DEFAULT / SELECTED /
FORMA
BUTTON ACTIVE INACTIVE DESCRIPTION / USE
T
STATUS STATUS
The Quality Control button (QC) opens the Quality control windows which allow Control Lots to be
added to the system and monitored via QC tables with integrated error flagging and Levey-
Jennings charts with monitoring statistics.
DEFAULT / SELECTED /
FORMA
BUTTON ACTIVE INACTIVE DESCRIPTION / USE
T
STATUS STATUS
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The Calibration button opens the Calibration window which allows Calibrator Lots to be added and
Calibration runs to be ordered. It also provides a method of reviewing Calibrator data and
Calibration Curves.
DEFAULT / SELECTED /
FORMA
BUTTON ACTIVE INACTIVE DESCRIPTION / USE
T
STATUS STATUS
The Configuration button opens the Configuration window. In Configuration parameters can be
reviewed and updated for the accessible parts of the protected ERBA methods. New methods can
be added and programmed. User defined methods can be deleted.
DEFAULT / SELECTED /
FORMA
BUTTON ACTIVE INACTIVE DESCRIPTION / USE
T
STATUS STATUS
The System button opens the system parameters. It includes Global, running menu, Printer, LIS
and a protected access to Service.
DEFAULT / SELECTED /
FORMA
BUTTON ACTIVE INACTIVE DESCRIPTION / USE
T
STATUS STATUS
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5.1.9. Status bar
At the bottom of the screen the Status bar gives information to the user on the status of the
instrument.
It is visible from all screen EXCEPT from the analysis menu.
The information listed in this area are: Colour coded Ready / Not Ready dot, temperature display,
presence of a USB key connected in at least one USB port date & time
Figure 5: Status bar, instrument warming up, temperature not reached: Not Ready, USB key connected
Figure 6: Status bar, temperature reached within range: Ready, No USB key
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To perform this:
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4. Click on the Calibrate button, the following window opens
Note: For the Erba methods the reagent name(s) are already filled in, loaded from the default
settings in the database. If the information is modified by the user, the last saved information
will be displayed in this screen as well as in the analysis mode at injection request and the
Information window from the analysis mode. For user defined methods, enter the name(s) as
needed to see them in the analysis information screen and in injection step of the method.
5. Fill the reagent name(s) as needed, this information is dynamic and takes it from the assay
configuration. So the number of products to be identified are linked to the configuration.
6. Leave the next page blank
7. Save the new information.
8. Then go to Analysis
9. Run the calibrator material as samples (See 5.4 for details)
10. Write down analyzer’s responses
11. Go back to the calibration and go to the second page
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12. Enter the Target and analyser responses for the different units
13. Then Save
Note: for some calibrations it is possible to view the Calibration curve, see 5.5.1 for more details
Note: It is possible to keep 2 different calibration curves per parameter if they are for 2 different
lot numbers. If more than 1 lot needs to store calibrations, then click on the Active Cal tbl. Drop
down list, select the 2 and enter calibration information and save. To recall the appropriate
calibration, select the 1 or the 2 from that field.
The software lets you define 12 different quality control materials which can be assigned to any or
all of the existing programmed methods.
If your Quality Control materials are already defined and the lots and values are already entered,
go to 5.2.2 Running Quality Control materials
If your Quality Control materials are already defined, but new lots and values need to be entered,
proceed to 5.3.1 step 4 to 7 before going to 5.3.2 Running Quality Control materials
1. Click on QC button
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2. Click on the Set QC button
4. If the name of the QC is already defined, select it from the drop down list
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5.3.2. Running Quality Control materials
To run Quality Control materials, refer to 5.4 running analyses.
Note: Quality Control material can be tested in the same run as patient samples
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2. Click on the desired Group of tests (Screening Tests, Factors, D-Dimer or Others)
Note: On the ECL 412, the assays or tests are organized in groups for easier routine work. Groups
of tests can include assays of different measurement modes. The selection of the assay will show
the channels to be used for it.
The Group of tests menu appears as the system is configured (first, the ERBA protected methods
will display, followed by the user defined assays)
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3. Select the desired assay,
4. The information screen will popup (as shown below), and will close automatically after 5
seconds, or can be closed with the OK button
Note: once this window is closed it can be recalled by clicking on the i icon located
on the left of the temperature displayed in the analysis mode.
5. Then the corresponding window will open, showing the name of the assay, a table to
display the results, and the channels that can be used for this assay.
Depending on the method configuration the assay can be run in single or duplicate.
When a test is configured in single determination, each channel will require to enter an ID number
(unless the System, Running Mode Identification is set OFF for Sample ID User defined; in which
case the sample ID will be set automatically and incrementally.)
When the system is configured in duplicate determinations, clicking on a channel will set the ID for
the duplicate channel.
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Figure 10: Analysis screen for Immunoturbidimetric (D-Dimer), configured in duplicate
Figure 11: Analysis screen for Chromogenic (AT III), configured in single
Figure 12: Analysis screen for Chromogenic (AT III), configured in duplicate
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7. Select Sample to run a sample (to run control, refer to Running Quality Control analysis)
8. Enter (or scan with external barcode reader) the ID as prompted-(unless the User Defined
Sample ID is deactivated from System, running Mode), the Sample ID can be up to 14
characters
9. Then the system prompts to ADD TUBE with blinking Green/Grey border. Place a clean
empty Erba reaction Cuvette in the prompted channel
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Note: The system will detect the presence of the cuvette automatically and move to the next
reaction step: ADD SAMPLE or ADD REAGENT 1 or the actual name of the reagent as defined in
the Calibration definition. When the user is prompted to add something the button frame
blinks between Grey to the current colour.
10. Pipette the sample or reagent as instructed, following the correct volumes as stated in the
section 2.2
11. The injection of the liquid will be automatically detected and the system will move to the
next step, for example Incubation as shown below
12. The incubation is counted down in seconds. The button frame is now Orange, the
countdown lettering is White.
13. When the countdown reaches 5 seconds before the end of incubation: The frame blinks
from orange to grey, giving the user a visual information to get ready to inject
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Note: the exceeding incubation time is monitored. If the exceeding time stays below 20sec,
the result is reported with no flag. Over 20sec, the result is then flagged for exceeded
incubation
15. Once the injection of the starter is automatically optically detected, the system starts
Measurement and display: the sample ID, Measure, the number of seconds being
measured.
16. The system will read until it finds the end of the clotting process and the measurement will
stop automatically as soon as it is detected.
17. If no clot is detected the measurement will be pursued until the end of the maximum
measurements as defined in the method configuration.
18. Once the end of the clotting reaction is detected, the system stops counting up seconds
and will quickly calculate and report the clotting time, the display switches to Sample ID,
RESULT, XX.X sec
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Note: if the system accidently misses a detection or moves to the next steps erroneously, it is
possible to go back or forward by clicking on the channel button to activate the double direction
arrows; click to the right to move forward, and left to move backward.
To activate the timed Preparation line, go to System, Running Mode, and activate preparation line
(refer to 5.7.2 for more details).
When running with the preparation line activated, the system will display 2 status lines, as shown
below
Perform your tests as usual, then during the process of the tests in the measuring channels, other
reactions of the same parameter can be prepared:
1. Click on the ADD NEW top button to open the dialogue box sample/control choice
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2. Select the type and either select the Control name or type the sample ID as during normal
operations on the measuring channel
3. The instrument will instruct and guide the user to the required steps,
4. to inform the system that the step has been completed, click on the status line button and
select the arrow to the right
5. When the measuring channel is freed-up then the system will instruct the user to transfer
the cuvette from the preparation line to the measuring channel by showing a down arrow
and automatically assign the sample ID of the preparation line to the measuring channel(s),
as shown below.
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As soon as the measuring channel detects the insertion of a cuvette, the status of the preparation
cuvette will automatically be transferred to the measuring channel.
Note: When the measuring channel gets freed up, wait a few seconds before transferring the
cuvette to the measuring channel
Take into account the assay algorithm and longest measuring time before starting a preparation to
avoid over incubation errors
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5.5. Retrieving results
1. Click on Calibration
2. Select the Group in which the assay you intend to view is organized
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Note: the data can also be reviewed from the input window
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But to review the Control results in the Quality Control program of the ECL 412:
1. Click on QC button
By default the table opens with the first assay of the list and the first QC material and its first unit
showing the different data points
Warning: If a QC point has broken Westgard rules, then the data point will be flagged with a
3. The user can select a result line and view its Details by clicking on the DETAIL button.
This window shows all units results of the assay determination point, its time of completion, its
potential alarms
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The reaction curve can be reviewed by clicking on the button if active (if the USB
key that was connected at the time of run is currently connected to the left side port).
The user can go to the next or previous QC results by using the Previous and Next
buttons
Once the Assay Name, QC material and desired units are selected:
6. If there are more data points than can be displayed in the window, use the arrows to the
right or left to move around the graph.
Note: The LJ graph automatically plots all determinations displayed according to their relation to
the Mean and SD
Data points are represented by a dot if its value is within 3SD and by a Triangle if it exceeds 3SD.
By default all QC points are accepted and included in the statistical calculations
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b. A dialogue box will open its details and will allow you to accept or reject it. By
default it will be accepted and therefore represented in a black shape
Note: Ignoring a point omit it from the Levey Jennings plotting linking the subsequent data points
together. The data point will remain but will be displayed as a Red dot or triangle instead of a black
shape.
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E. Results can be deleted :
This window shows all units results of the assay determination point, its time of completion, its
potential alarms and its reaction curve if the USB data key that was connected at the time of run is
currently connected to the left side port.
The reaction curve can be reviewed by clicking on the button if active (if the USB
key that was connected at the time of run is currently connected to the left side port).
The user can go to the next or previous QC results by using the Previous and Next
buttons
Press the X to close the Details window
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c. Click in the DATE field and the Calendar dialogue box will open
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i. Fill the date information as required.
d. Activate the filter(s) by clicking on the desired button(s)
Selected items will be displayed in Orange buttons as seen below.
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2. Then Click on the NEW METHOD button, the following window opens:
3. Click in the Method name field, the virtual keyboard automatically opens as shown
below
4. Type the name of the new desired method (Maximum 14 characters) and press the
Enter key
5. Select the group name where you wish to place the new method, as shown below
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6. Click on the SAVE button. The method name is saved and can be seen in the group
name selected.
7. To configure the method,
i. click on the group name where it is organized,
ii. click on the assay name, and
iii. go to METHOD PARAMETERS. See 5.6.3 for instructions.
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To do so:
Note: If a pre defined Erba Method is selected, the DELETE METHOD button is not active. Only
User defined methods can be deleted.
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A message will be displayed to confirm the requested deletion:
“Once a method is removed, all results, calibration and controls linked to this method will be
discarded and lost. Are you sure you want to delete this method?” YES/NO
To do so:
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3. Then click on the METHOD PARAMETERS button, the following window opens
The steps should follow one another. For each step define the action in the Add column from
the drop down list, whether the instrument will request a mixing by user if the check box is
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ticked, and the incubation time in sec before the next step, and the volume in µl of the product
(the volume information is reported into the Information screen in the analysis mode).
o Sample
o Reagent
o Reagent 1
o Reagent 2
o Reagent 3
o Reagent 4
o Diluent
o Buffer
o Latex
v. Then the measurement timing definition
o Min read time (corresponds to the minimum time of measurement for a clotting
time or the First measurement for a Chromogenic or turbidimetric assay)
o Max. read time (corresponds to the maximum time of measurement for a clotting
time or the Second measurement for a Chromogenic or turbidimetric assay)
o Lag time (occulted time for clotting tests)
5. Click on the SAVE button to save the data from page (1/2)
6. Click on the NEXT PAGE button to get to the next page (2/2) of the method
parameters
7. Fill in the information present in page 2/2 of the method parameters:
i. Units: Enter up to 3 units per assay
o Sec
o %
o INR
o INR calib
o Ratio
o g/L
o mg/dL
o mg/L
o ng/mL
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o µg/mL
o µg FEU/mL
Note : All the units in blue are linked: once one of them is selected from the list of units for
main, 2nd or 3rd, another one blue cannot be selected as another unit
ii. For each unit select the reporting format (decimal format 9, 9.9; 9.99)
iii. Enter the Normals and limits of the method
o Normal values (Min – Max)
o Sensitivity limit of the method
o Linearity limit of the method
All expressed in the main unit selected above
v. Enter the appropriate correlation factor if needed (correction of AX+B type; by default A=1
and B=0)
vi. By default the main unit is active (checked), but for example for an Erba protected method
for PT, 3 units are selected %, INR and Sec. if the lab only wants to report in INR and Sec and
not calibrate, then the user can deactivate the main (%) unit. In that case uncheck the box.
vii. Dilution ratio information (will be displayed on the information window from the Analysis
mode)
viii. Enter the Alert level (it is in number of ml left or number of tests depending on the assay
when RFID manages the reagents for alerts. If managed it will also be used in the warning
alert message in the analysis mode).
8. Click on the SAVE button to complete the method parameters saving,
9. A confirmation message will be displayed. Say YES to confirm or NO to discard the
newly entered information
10. Close the window by pressing the X on the upper right corner of the window.
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5.7. System
The system is where all instrument settings are defined and stored. All of the following items are
located in the SYSTEM section of the software. Click on the System icon to access them, then on
the left list of elements:
Global
Running Mode
Printer
LIS
Service
5.7.1. Global
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RFID:
o When new supply needs to be entered into the system (reaction cuvettes),
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o then place the kit orienting the RFID tag next to the RFID logo on the left side of
the instrument
o Click on the RFID button
o A message appears giving a 5 seconds count down for the tag to be read.
o Once the tag is read, the system displays what is on the tag in the RFID field and
what related information is registered on the system in the Device field.
o Enter the number of cuvettes you wish to transfer from the tag to the devise
o Then click on the logo (tag to device) to save it
o If the laboratory is equipped with more than one compatible device and too much
supply has been transferred by mistake to the device, supply can be placed back to
the Tag by pressing the (Device to Tag) logo
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5.7.3. Printer
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5.7.4. LIS
The ECL 412 can be connected to an LIS and send automatically the results to the host computer.
Once the LIS window opens by default with Serial connexion option selected
It displays the information needed to be configured to achieve the communication with the Host
computer. This includes: Port #, speed, data bit, parity, stop bits, flow control, etc.
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If the Ethernet type connexion is selected then the host IP needs to be entered in the appropriate
field. Click on the Settings button to access the Device Setting
5.7.5. Service
Service is only accessible to your technical service representative and is protected by special access
codes.
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6. Installation
6
Is a level surface
Is away from direct sunlight
Is a at least 300 mm (W) x 290 mm (D)
Has at least 100 mm left horizontal clearance for USB key manipulation
Has at least 100 mm back clearance to ensure ventilation
Is sturdy enough to sustain 4 kg of the equipment, plus the operator’s manipulations.
Is within 2 m of a grounded electrical power outlet
Temperature conditions are to be within specifications 17-32°C
Humidity Maximum 80% Relative Humidity, non-condensing
Avoid dusty area
Avoid placing in a draughty area
Avoid direct exposure to cooling or heating devices
1 2
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3 4
5 6
Secure the power supply and the appropriate power cable that matches the country and
insuring that proper grounding can be achieved with the cable and the socket
Plug the power supply to back of instrument first, insuring tight connection (see 2.4.1)
Then plug the power cord to the wall socket
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6.2.4. Precaution guide
Hardware requirements:
Improper grounding to instrument bypasses the important safety features and may
result in biased results or in permanent damage to the analyzer that may void the warranty. It is
necessary to ensure proper grounding. The main electrical network should comply NFC15100
standard.
Warning: Installing the ECL 412 in an area with known power supply issues such as
frequent power surges or power outages is not advisable. It is recommended that the instrument
be connected to an Uninterruptible Power Supply to ensure instrument safety.
Warning: The safety disconnect device is the main plug. Ensure this plug remains
easily accessible.
Warning: For any replacement of the power cord, it must comply the IEC 320
standard and with less than 3 meters long. The minimum rated current is 5A
Warning: Placing devices that can generate vibrations, such as printers, centrifuges,
agitators, etc … on the same bench as the ECL 412 must be avoided
Warning: The external USB devices should actually comply CE mark to avoid
unstable functionality
Warning: Full reliability of results is only achievable with reagents provided and
validated by Erba group
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Bio Hazard: Consider all human-source materials, like controls and calibrators,
as potentially infectious
Bio Hazard: Dispose of all the liquid and solid waste in accordance with
local and national regulations. Liquid waste pre -treatment is recommended
Bio Hazard: Decontaminate all parts of the instrument before service intervention.
Use an alcoholic solution (Ethanol, Iso Propanol), do not use bleach as it can damage the incubator
surface, and do not use solvents that can damage the plastic covers.
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7. Maintenance
7
7.1. Daily
Beginning of day
End of day
Turn OFF instrument
Remove all used cuvettes and reagent containers.
Remove dust and or spills from the surface of instrument using water and dry completely.
Note: if a decontamination of the surface is to be done, use a 1+1 solution of alcohol and water,
and dry completely.
Warning: Do not use solvents or strong bleach that could damage the coating of the cover and
heating block
7.2. Weekly
There is nothing special to be done on a weekly basis.
7.3. Monthly
There is nothing special to be done on a monthly basis.
7.4. Quarterly
There is nothing special to be done on a quarterly basis.
7.5. Annually
There is nothing special to be done on a yearly basis.
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But depending on the accreditation of the laboratory, if requalification is required the follow
elements should be checked:
1. Measurement elements
2. Temperature controlled elements
3. Stirring function
The following sections 7.5.1 to7.5.3 are intended for technical service personnel and only as
indications / information for the user.
If the values are not within range, the channel optics should be cleaned with dust blower used as
an aspiration tool in conjunction with the brush side.
Using the service menu the engineer will read the AD values of all 4 channels using 2 different
reference cuvettes.
Using the service menu the engineer will read the AD values of all Channels 1 & 4 using an IR
filtered glass reference cuvettes.
Using the service menu the engineer will read the AD values of channels 2 and 3 using 2 different
cuvettes.
With the 830 S reference cuvette, required AD range in both channels: 975 – 1625.
With a distilled water filled cuvette, required AD range in both channels: 3600 – 6000.
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7.5.2. Verification / recalibration of temperatures
The instrument controls temperatures in the measuring channels as well as in the incubation areas.
The verification / recalibration of these temperature can be done by a service engineer using the
service program and specific temperature tools.
The verifications should be done in the channels and location as marked in the picture below.
These points being the most distant from the heating source and the temperature sensors.
Figure 16: temperature checking points: Channels 1 & 4, Top line of 3rd column for incubation positions and
lower right 37°C reagent incubation position
If the temperatures are not within the acceptable range of 37°C +/- 0.5, then a recalibration is
needed.
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8. Troubleshooting
8
Observation Meaning
Critical alarm
Instrument
Switching ON the instrument does not start the Insure that the power supply unit and
instrument its wires are free of damage
Insure that the Power cord is
connected securely (from wall to
power adaptor
Insure power adaptor is connected to
the back of the instrument securely
(see 4.1 Starting up the instrument)
The instrument does not give a signal beep for Go to System, Global and check that
starting reactions the system is not on Mute
See 5.7.1 System, Global
Error messages
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Observation Meaning
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Observation Meaning
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Observation Meaning
The maximum read time cannot be smaller than Correct the inputted information
the lag time!
The maximum read time cannot be smaller than Correct the inputted information
the minimum read time!
The lag time cannot be bigger than the minimum Correct the inputted information
read time!
The lag time cannot be bigger than the maximum Correct the inputted information
read time!
RFID read failed! The instrument was not able to read the
RFID tag
Make sure the RFID label is correctly
positioned next to the antenna
(where the RFID logo is located on
the left of the instrument)
Retry the procedure
Device is overheated! Turn off and unplug the instrument
and all the power supply elements
Contact your technical service
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9.9 Performance
9.1. Precision
The analyser ECL412 performance were evaluated with the Erba reagents. Results are as follows.
**CV limits are taken for the normal concentrations from guidelines “Normes d’acceptabilité en
Hémostase” of GEHT, August 2014. GEHT is a study group of the French Society of Hematology
who developed these guidelines in cooperation between members of GEHT, the main associations
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of French quality controls and the National Security Agency drug and health products (ANSM). CV
limits vary depending on the different concentrations for each analyte.
9.2. Limits
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10. LIS
10 Setup
10.1. General
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10.2.1.2. ECL412/105 RS232 connection
The serial cable must be plugged to the standard DB9 connectors of the PC, referenced in the
Windows system as « COM Ports ».
If it is not the case, you must plug in the PC either an electronic card (RS 232 serial card), or use an
USB-Serial adapter (if you PC has USB ports).
The network connection is done by plugging an Ethernet RJ 45 Category 5 cable connector to the
network connector of ECL412/105.
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The ECL412/105 System only sends the result data of measurement. When a measurement is done
the system automatically tries to send on the selected LIS port.
10.4. Protocols
When using serial port, the ECL412/105 System works with 2 standard protocols:
- ASTM 1381 for « physical » communication : this protocol describes the mechanisms of
data send
- ASTM E 1394 for « logical » communication : this protocol describes the mechanism of
data coding ( test requests, queries, results)
With Network communication, only ASTM E 1394 protocol is used: the physical protocol is the
chosen network protocol (generally TCP/IP).
<STX><Frame #><Data><ETX><Checksum><CR><LF>
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START
ENQ Received
5 seconds
EOT received
Send ACK File reception complete
N
New files in
\ASTM\OUT Wait Frame reception
folder
?
Frame reception
Y
Frame analysis
Y N
Frame OK ? Send NAK
Connection Established
Send ENQ
NAK ACK
10 Received Received
seconds
Other file to send ?
n > nb frames of the file
Send Frame N
Send EOT - file completed =>
ACK NAK TimeOut 5s Move in \ASTM\OUT\Done
Received received folder
n=n+1
Completed
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The Logical protocol ASTM E 1394 allows communication between LIS and ECL412/105 System:
Send the results
10.4.3. Results
Once tests are completed, the ECL412/105 System sends the results.
A result message contains only data for one sample but it may contain one or more result for one
or more analysis.
a H line (header)
a P line (patient)
Example:
H|\^&|||||||ECL_412
P|1||1
O|1|1||^^^Fibriogen|||||
R|1|^^^Fibriogen|34.884365|Sec||||||||20150625162726||
L|1
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Sending several results:
When the transmission of several results of an analysis is needed (for example, PT with seconds,
percent and INR):
H|\^&|||||||ECL_412
P|1||1
O|1|1||^^^PT|||||
R|1|^^^PT|34.884365|%||||||||20150625162726||
R|2|^^^PT|0.000000|INR||||||||20150625162726||
R|3|^^^PT|9.200000|Sec||||||||20150625162726||
L|1
Date/Time of execution:
The 13th Field contains date and time when test has been completed on the ECL412/105 this date
format is YYYYMMDDHHMMSS
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Fields Table:
H Line
Field n°1 :
1st character H
Ligne P
1 P
2 Sequence number
3 Unused field
4 Patient ID
Ligne O
1 O
2 Sequence number
3 Sample ID
4 Unused fields
5 Analysis parameters :
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6-10 Unused fields
Ligne R
1 R
2 Sequence number
3 Analysis parameters :
4 Result
5 Unit
L Line
1 L
2 Sequence number
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11 Disposal
11.
11.1. End of life disposal
Before disposing the instrument, please contact the local Erba Lachema representative. Full
instruction will be provided for instrument proper and complete disposal process in compliance of
local and national regulations.
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12 Packaging
12.
12.1. Transport requirements
Transport Environment limit ranges
Temperature: 5-40°C
Humidity: 5- 90% (non-condensing)
Chock: < 35G
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13 Contact
13.
For customer and technical support:
Manufacturer:
Website: https://www.erbalachema.com/en/product-support/
Contact your local technical support: (Print this page and write or paste contact information for
easy access)
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