ECL 412

4 Channel Semi automated

Coagulometer

USER MANUAL
INS00060

Date of last revision:

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ 04/2022
COAG/IFU/015/22/A
User Manual
ECL 412

Copyright
Copyright © 2022, Erba Lachema s.r.o. All rights reserved.

This manual contains material proprietary to Erba Lachema and is proteced by copyright laws.
Therefore, the manual and any of its content must not be modified, reproduced, transmitted or
translated without the written consent of Erba Lachema.

Disclaimer
All information, of a technical nature, and particulars of the ECL 412 Analyser 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 Analyser 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 prescribed use and the instrument maintenance
procedures will void the warranty and may result in injuries.

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ECL 412
Icons

The following icons are used on the instrument to aid the user:

Attention (caution) Read the instructions for use for important cautionary
information such as warnings and precautions.

See Instructions Read the instrustions for use carefully before attempting
for Use practically.

Biological Risks Be aware that this product poses some biological risk due to
the nature of the material it analyses.
Take appropriate precautions noted in this User Manual
below.

Storage Store the product at the specified temperatures.

Temperature

In vitro diagnostic This instrument is covered by the European

medical device In Vitro Diagnostics Directive.

CE marking of confor- This product is CE marked.

mity – IVD complies
with the Regulation
(EU) 2017/746

Manufacturer: Erba Lachema s.r.o., Czech Republic

Serial Number: Denotes the product serial number.

Humidity limitation: Indicates the range of humidity to which the medical devi-
ce can be safely exposed.

Atmospheric pre- Indicates the range of atmospheric pressure to which the

ssure limitation: medical device can be safely exposed.

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ECL 412 User Manual

Classified The symbol on the product indicates that this product may not
collection of be treated as a household waste. Instead it shall be handled
electrical to the applicable collection point for the recycling of electrical
and electronic and electronic equipment. By ensuring this product is disposed
equipment of correctly, you will help prevent potential negative conse-
quences for the environment and human health, which could
otherwise be caused by inappropriate waste handling of this
product. Please contact your local city office or your distribu-
tor 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 particu-

lar 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 REPRESENTA-
TIVE to be informed of his responsibilities

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ECL 412

The following iconography is used throughout this manual to help the user:

Attention (caution) Please pay special attention to notices with this mark. There is
potential for risk to the operator or instrument safety.

Note This point is worthy of note.

See Instructions Read the instructions for use of instrument and reagents
for Use carefully before attempting practically.

Biological Risks Decontaminate all parts of the instrument before service

intervention.

Observe appropriate precautions when using this instrument,

handling sample material or clinical waste; laboratory coat,
gloves, protective eye wear.

Consider all human-source materials, like controls and calibrators,

as potentially infectious.

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1. Contents

COPYRIGHT 3
DISCLAIMER 3
ICONS 5
1. CONTENTS 8
2. OVERVIEW 11
2.1. General Description 11
2.2. Intended Use 11
2.3. Operating Principles 12
2.3.1. Determination of Clotting times 12
2.3.2. Chromogenic measurements 12
2.3.3. Immuno-turbidimetric measurements 12
2.4. Instrument specifications 12
2.5. Device presentation 14
2.5.1. Module positions 14
2.5.2. Module Description 15
2.5.2.1. Colour touch screen 15
2.5.2.2. Built-in thermal printer 15
2.5.2.3. 37°C temperature controlled area 15
2.5.2.3.1. Measuring channels 15
2.5.2.3.2. Reaction cuvettes incubation area 15
2.5.2.3.3. 37°C reagent incubation area 15
2.5.2.3.4. Reagent Stirring device 15
2.5.2.4. Ambient temperature reagent incubation area 15
2.5.2.5. Radio Frequency Identification (RFID) 16
2.5.2.6. Interface 16
2.5.2.6.1. ON/OFF switch 16
2.5.2.6.2. External Power Supply 16
2.5.2.6.3. Serial Port 16
2.5.2.6.4. USB ports type A 16
2.5.2.6.5. USB port type B 16
2.6. ECL 412 Accessories list 17
3. INSTALLATION 18
3.1. Site Preparation 18
3.2. System Preparation 18
3.2.1. Unbox the system 18
3.2.2. Prepare the system for installation 19
3.2.3. Install paper roll 20
3.2.4. Precaution guide 20
4. ANALYSES PREPARATIONS 22
4.1. Starting up the instrument 22
4.2. Loading of consumables 22
4.3. Preparation of samples 23
4.3.1. Pre analytical preparations of samples 23

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4.3.2. Specific sample preparation 23

4.3.3. Preparation of calibrators 24
4.3.4. Preparation of reagents 25
5. USER INTERFACE 27
5.1. Software general introduction 27
5.1.1. Start-up Screen 27
5.1.2. Top Bar 27
5.1.3. Analysis button 28
5.1.4. Results button 28
5.1.5. Quality Control button 28
5.1.6. Calibration button 29
5.1.7. Configuration button 29
5.1.8. System button 29
5.1.9. Status bar 30
5.2. Calibration 31
5.2.1. Introduction 31
5.2.2. Calibration material 31
5.2.3. Running Calibration 31
5.3. Quality Controls 33
5.3.1. Introduction 33
5.3.2. Quality control material 34
5.3.3. Defining Quality Control materials 35
5.3.4. Running Quality Control materials 37
5.4. Running analyses 38
5.4.1. Running analyses in single or duplicate 40
5.4.2. Case of clotting tests 40
5.4.2.1. Case of Immuno-Turbidimetric tests 41
5.4.2.2. Case of Chromogenic tests 41
5.4.3. Running analyses with Preparation line activated 46
5.5. Retrieving results 48
5.5.1. Retrieving Calibration results 48
5.5.2. Retrieving Quality Control results 50
5.5.3. Retrieving sample results 53
5.6. Configuration (of Assays) 58
5.6.1. Creating new method 58
5.6.2. Deleting existing method 59
5.6.3. Method parameters 61
5.7. System 64
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. MAINTENANCE 70
6.1. Daily 70

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6.2. Weekly 70
6.3. Monthly 70
6.4. Quarterly 70
6.5. Annually 70
6.5.1. Measurement elements checks 71
6.5.1.1. Checking the Nephelometric measurements 71
6.5.1.2. Checking the InfraRed measurements 71
6.5.1.3. Checking the UV measurements 71
6.5.2. Verification / recalibration of temperatures 71
6.5.3. Stirring function checks 72
7. Troubleshooting 73
7.1. Diagnostics Chart 73
8. Performance 76
9. LIS Setup 77
9.1. General 77
9.2. Hardware configuration 77
9.2.1. Serial communication 77
9.2.1.1. Cable specifications 78
9.2.1.2. ECL412/105 RS232 connection 78
9.2.2. Network communication 78
9.3. Work mode 79
9.4. Protocols 79
9.4.1. Physical protocol: ASTM 1381 79
9.4.2. Logical protocol: ASTM E 1394 81
9.4.3. Results 81
10. DISPOSAL 83
11. PACKAGING 84
11.1. Transport requirements 84
11.2. Packaging labels 84
12. CONTACT 85

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2. Overview

Warning: if the equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired

2.1. General Description

The Erba Mannheim ECL 412 Analyser is a 4 channel semi-automated coagulometer. It is an in vitro
Diagnostics device for use in clinical laboratories by qualified personnel only and trained on the
system by Erba Lachema personnel or an Erba Lachema representative or distributor. It can perform
assays using 3 types of optical measurement principles: Clotting, Turbidimetric and Chromogenic on
centrifuged citrated plasmas.

2.2. Intended Use

ECL 412 is semi-automated coagulometer for in vitro qualitative or quantitative measurement of
hemostasis parameters in human blood plasma. The results of tested hemostasis parameters can
be used for their screening, monitoring and diagnosis. The function is specifically dependent on
each parameter and is described in IFU of every Erba reagent kit. For professional use in clinical
laboratory only.
Volume of Predilu- Volume of diluted
Number of Volume of rea-
Assay pure sample tion of the sample (when
reagents gents required
required sample applicable)
Screening tests:
PT 50μl — — 1 100μl
APTT 50μl — — 2 50+50μl
Fibrinogen 10μl 1/10 100μl 1 50μl
TT 100μl — — 1 50μl
Factors:
Extrinsic factors: Fact II,
8μl 1/5 40μl 2 40+80
Fact V, Fact VII, Fact X
Intrinsic factors: Fact VIII,
5μl 1/5 25μl 3 25+50+50
Fact IX, Fact XI, Fact XII
D-Dimer
D-Dimer 15μl — — 2 75+60
Others
AT III 5μl 1/100 50μl 2 50+50
Protein C 13μl 1/4 50μl 2 50+50
Protein S 5μl 1/10 30μl 4 30+30+30+30
Lupus DRVV screen 75μl — — 1 75
Lupus DRVV Confirm 75μl — — 1 75
Other tests (as defined by user)

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2.3. Operating Principles

The ECL 412 uses optical detection for 3 types of analyses:
• Determination of clotting time
• Chromogenic measurements
• Immuno-Turbidimetric measurement

2.3.1. Determination of Clotting times

On Channel 1 to 4, the detection of clotting time is done optically, by measuring the scattered light
generated by the formation of the fibrin clot in the mixture when sample and necessary reagent(s)
are combined respecting the necessary incubation times.
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.

2.3.2. Chromogenic measurements

On Channels 2 and 3, the chromogenic measurements are done using a LED emitting at 405nm.
A photo detector positioned on the other side of the cuvette measures the intensity of the light
after crossing the reaction mixture. The intensity of the light will vary as the reaction evolves and
the Optical Density (OD) is calculated. The Delta OD (dOD) is calculated from the beginning of the
reaction to the end. Using a calibration curve with known concentrations, the patient sample is
calculated in % activity or units.

2.3.3. Immuno-turbidimetric measurements

On Channels 1 and 4, the turbidimetric measurements are done using a LED emitting at 800nm. A photo
detector positioned on the other side of the cuvette measures the intensity of the light after crossing
the reaction mixture. The intensity of the light will vary as the reaction evolves and the Optical Density
(OD) is calculated. The Delta OD (dOD) is calculated from the beginning of the 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 in-
tensity 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.

2.4. Instrument specifications

ECL 412 is a:
• 4 channel semi-automated haemostasis instrument
• It can perform 4 simultaneous tests of the same parameter
• It is also possible to have a second row of assay preparation/incubation during the analysis
of the current line

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ECL 412

• It can run assays in single or duplicate (programmable per assay).

• Optically detects and automatically moves to the next assay steps and auto starts the meas-
urements

Tests principles:
• Clotting (scattered light at 640nm)
• Chromogenic (colorimetry at 405nm)
• Immuno-turbidimetric (turbidimetry at 800nm)
See Chapter 2.3. for details of operating principles.

Dimensions / Weight:
• Dimension: 300 x 290 x 90 mm
• Weight: 3 kg

Environmental requirements:
• Operating Temperature: 17-32°C
• Humidity: Max. 80% Relative Humidity, non-condensing

Power:
• Power Supply: 100-240 V AC a 50/60 Hz
• Power Consumption: 45 Watts
• In-Rush Power: 150VA or less

Calibrations:
• Up to 6 calibration levels per assay
• Storage of the active calibration curve

Quality Controls:
• Up to 12 different control names total can be assigned to any given assay.
• Automatic Levey-Jennings plotting
• Automatic statistics calculation
• Storage of Quality Control results

Stored results:
• Independent storage allocation in the instrument memory for Quality Control (QC) and patient
determinations
• Up to 600 results for QC determinations (run in duplicate)
• Up to 900 results for patients (run in duplicate)
• New results automatically replace the oldest results of the appropriate category past the
maximum storage allowance
• Reaction curves are exclusively stored on the external USB pendrive.
• Regular backup and file purging is recommended from the USB pendrive to insure rapid opera-
tions. (We recommend at least a monthly purge from a computer to back up and remove CH files).
• Should a reformatting of the USB pendrive be needed, perform as FAT32

For additional information about the hardware, refer to 2.5. Device presentation.

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2.5. Device presentation

2.5.1. Module positions
1 = Colour touch screen
2 = Build-in Thermal Printer cover
3 = 4 measuring channels
4 = Incubation area for reaction cuvettes
5 = 37°C reagent incubation area:
• One 30 mm Diameter vial with
programmable stirring
• Six reagent cups
6 = Ambient reagent incubation area:
• One 30 mm Diameter vial with
programmable stirring
• Six reagent cups
7 = 37°C temperature controlled area
Figure 1: ECL 412, top/Front view

1 = 1st master USB port

2 = RFID receptor

Figure 2: ECL 412 Left side view

1 = Build-in Thermal Printer cover

Figure 3: ECL 412 rear view
2 = Slave USB port
3 = 2nd master USB port
4 = RS232 serial port
5 = RJ45 Ethernet port
6 = Power supply unit connector
7 = ON/OFF switch

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2.5.2. Module Description

2.5.2.1. Colour touch screen

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.

2.5.2.2. Built-in thermal printer

The device is a 2 inches integrated thermal printer. It prints automatically and/or on demand
results and other information.

2.5.2.3. 37°C temperature controlled area

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.

2.5.2.3.1. Measuring channels

There are 4 measuring channels on the ECL 412:
• The 4 can all perform nephelometric (clotting by scattered light) measurements
• The 2 central ones can also perform colorimetric (chromogenic) measurements at 405nm
• The 2 external ones can also perform turbidimetric (immunologic) measurements at 800nm

2.5.2.3.2. Reaction cuvettes incubation area

This area is composed of 20 positions (4 columns of 5 cuvette holes, aligned with the measure-
ment channels). It can hold the reaction cuvettes.

2.5.2.3.3. 37°C reagent incubation area

In this area, which is heated to 37 ° C, there are a total of 7 positions:
• 1 position for a 30 mm bottle (or 22 to 24 mm bottle with adapter). This position is equipped
mixing device.
• 6 positions for 3 ml reaction caps for reagent incubation

2.5.2.3.4. Reagent Stirring device

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 de-
activated from the System (running mode) section of the software. This activation / deactivation
is common for the 37°C and ambient reagent positions.

2.5.2.4. Ambient temperature reagent incubation area

This area is composed of a total of 5 reagent positions:
• 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

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2.5.2.5. Radio Frequency Identification (RFID)

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.

2.5.2.6. Interface
At the back and on the side of the ECL 412 a number of connections and buttons are present.

2.5.2.6.1. ON/OFF switch

This switch is used to turn the instrument ON and OFF.

2.5.2.6.2. External Power Supply

The ECL 412 analyser 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.

2.5.2.6.3. Serial Port

The Serial port is a RS232 9 pin connector for serial communication to the LIS.

2.5.2.6.4. USB ports type A

2 master USB ports are present, one on the left side of the instrument and one in the back. Either
one can be used to allow automatic saving of the reaction curves, which can be viewed when
checking details in the Results.

Type A (hest os hub)

2.5.2.6.5. USB port type B

A slave USB port is present and can be used.

Type B (peripheral)

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2.6. ECL 412 Accessories list

The ECL 412 analyser is delivered with the following accessories:

Item Quantities

ECL 412 Analyser 1

External universal power supply 1

External power cord 1

Instrument dust cover 1

Stylus 1+1

USB Pendrive 1

User Manual (on Pendrive) 1

Single Reaction Cuvettes, SRC -10 (bag) 500

Reagent Cups (bag) 50

Reagent Vial- 24mm Diameter 2

Autohandle pipettor (adjustable from 10 to 100μl) 1

Stir magnetic bars 5

Metal black adaptor ring 30 to 25mm 1

Metal black adaptor ring 30 to 23mm 1

Plastic White adaptor ring 30 to 25mm 1

Thermal paper roll 57mm 3

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ECL 412 User Manual

3. Installation

3.1. Site Preparation

Ensure the bench space chosen for the ECL 412
• 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

3.2. System Preparation

The instrument is packed in an inner box, and accessories around it in the outer box

3.2.1. Unbox the system

1 2

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3 4

5 6

• Open the outer box 1

• Remove the accessories to uncover the inner box 2
• Check the accessories against the packing list and place them securely aside
• Remove the inner box with the instrument 3 4
• Open the inner box as shown on pictures 5 6
• Remove the instrument from the outer box (Hold the instrument securely)
• Remove the protecting bag
• Verify that the system is free from any visible damage

3.2.2. Prepare the system for installation

• Secure the power supply and the appropriate power cable that matches the country and in-
suring 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 2.5.1.)
• Then plug the power cord to the wall socket

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3.2.3. Install paper roll

• Open the printer cover
• Install paper roll in lodgement with free pan facing you
• Insure that the free pan of paper is longer than the lodgement itself so that it will stick out
upon closing the lid
• Simply close the lid

3.2.4. 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 analyser 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

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Warning: Avoid dropping any liquid on surface of instrument to avoid damage

Warning: Full reliability of results is only achievable with reagents provided and validated
by Erba group

Bio hazard requirements:

Bio Hazard: Observe appropriate precautions when using this instrument, handling
sample material or clinical waste; laboratory coat, gloves, protective eye wear.

Bio Hazard: Consider all human-source materials, like controls and calibrators, as po-
tentially 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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4. Analyses preparations

Before running analyses, it is important to prepare everything. This includes:

• The instrument
• The samples
• The reagents

4.1. Starting up the instrument

1. Visually check the instrument:
• That it is clean
• That its power supply unit is correctly connected into the instrument power supply
connector socket
• That the power supply unit and its wires are free of damage before turning ON the unit.
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).

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 tem-
perature range).

4.2. Loading of consumables

On the ECL 412, the system keeps track of supplies (Reaction cuvettes).
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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4.3. Preparation of samples

4.3.1. Pre analytical preparations of samples

Preanalytical steps are crucial to obtain accurate results. In order to preserve the various
coagulation factors, special care must be taken when collecting the blood from the patient,
following professional standards.
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 precau-
tions when using this instrument, handling sample material or clinical waste;
use laboratory coat, gloves, protective eye wear.

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 i icon.

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.

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Consumption for duplicate

Parameter Reagents to be used Sample consumption/Test
tests for dilutions
PT PT Reagent 50 μL
APTT Reagent + Calcium
APTT 50 μL
Chloride
20 μL: 30 μL
Owrens Veronal Buffer
Fbg 180μl of buffer +20μl of 270μl of buffer + 30μl of
and Thrombin Reagent
sample sample

TT Thrombin Time Reagent 100 μL

Extrinsic Owrens Veronal Buffer + 20 μL:

20 μL:
Factor Factor-deficient Plasma + 80μl of buffer +20μl of
80μl of buffer +20μl of sample
PT based PT Reagent sample
Intrinsic Owrens Veronal Buffer +
20 μL:
Factor Factor-deficient Plasma + 20 μL:
80μl of buffer +20μl of
APTT APTT Reagent + Calcium 80μl of buffer +20μl of sample
sample
based Chloride
DDimer DDimer Buffer + Latex 15 μL
AT III
Prot C
Diluent + Prot S R1 + R2 + 10 μL 10 μL
Prot S
R3 + R4 90μl of diluent + 10μl of sample 90μl of diluent + 10μl of sample

Lupus DRVVT
Lupus screen 75 μL
Screen

Lupus DRVVT
Lupus confirm 75 μL
Confirm

4.3.3. Preparation of calibrators

Parameter Diluent to be used Dilutions of calibrator
For % calibration, reconstitute the set of calibrators accor-
PT N/A
ding to insert (Ref EHL00013 Erba-PT - INR MultiCal)
APTT N/A N/A
Calibrator: ref. EHL00012 Erba Standard Plasma
Owrens Veronal
Fbg 4 point calibration
Buffer
X2, Pure, ½, 1/3; resulting in 1/5, 1/10 , 1/20 , 1/30
TT N/A N/A
Calibrator: ref. EHL00012 Erba Standard Plasma
Extrinsic Factor Owrens Veronal
4 point calibration:
PT based Buffer
Pure, 1/2 , 1/4 , 1/8; resulting in 1/5, 1/10, 1/20, 1/40
Calibrator: ref. EHL00012 Erba Standard Plasma
Intrinsic Factor Owrens Veronal
4 point calibration:
APTT based Buffer
Pure, 1/2 , 1/4 , 1/8; resulting in 1/5, 1/10, 1/20, 1/40
Calibrator: ref. EHL00018, EHL00044 or EHL00049 DDimer
DDimer Ddimer Diluent calibrator, 6 point calibration:
Pure, 1/2 , 1/4 , 1/8; 1/16 , 1/32

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Parameter Diluent to be used Dilutions of calibrator

DILUTED AT III Calibrator: ref. EHL00012 Erba Standard Plasma
AT III Diluent 1/5 in disti- 4 point calibration: Pure, 1/2 , 1/4 , 1/8; resulting in 1/100,
lled water 1/200, 1/400, 1/800
Calibrator: ref. EHL00012 Erba Standard Plasma
Prot C Prot C diluent 3 point calibration:
Pure, 1/2 , 1/4 ; resulting in ¼, 1/8, 1/16
Calibrator: ref. EHL00012 Erba Standard Plasma
Prot S Saline
Prot S 3 point calibration:
solution
Pure, 1/2 , 1/4 , 1/8; resulting in 1/10, 1/20, 1/40
Lupus
N/A N/A
DRVVT Screen

Lupus N/A N/A

4.3.4. Preparation of reagents

Before running, prepare the necessary reagents. Prepare reagents taking into account the volumes
used per test and the number of tests to be performed during the run/shift as needed.
Consumption for dupli-
Parameter Reagent Consumption/Test
cate tests for dilutions
PT PT Reagent 100 μL
APTT Reagent 50 μL
APTT
Calcium Chloride 50 μL
180 μL: 270 μL:
Owrens Veronal Buffer 180μl of buffer +20μl of 270μl of buffer + 30μl
Fbg sample of sample
Thrombin Reagent 50 μL
TT Thrombin Time Reagent 50 μL
80 μL:
Extrinsic Owrens Veronal Buffer 80μl of buffer +20μl of
Factor sample
PT based Factor-deficient Plasma 40 μL
PT Reagent 80 μL
80 μL: 80μl of buffer 80 μL: 80μl of buffer
Intrinsic Owrens Veronal Buffer
+20μl of sample +20μl of sample
Factor Factor-deficient Plasma 25 μL
APTT
based APTT Reagent 50 μL
Calcium Chloride 50 μL

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Consumption for dupli-

Parameter Reagent Consumption/Test
cate tests for dilutions
180 μl dilution in 2 270 μl dilution in 2
steps: steps:
AT Xa diluted dilution Dil1= 90μl of buffer + Dil1= 90μl of buffer +
buffer 10μl of sample, 10μl of sample,
AT III Dil2= 90μl of buffer + Dil2= 180μl of buffer +
10μl of Dil1 20μl of Dil1
AT Xa R1 50 μl
AT Xa R2 50 μl
DDimer Buffer 75 μl
DDimer
DDimer Latex 60 μl
60 μl: 60μl of PC Dil° 120 μl: 120μl of PC Dil°
Prot C Dilution buffer
buff. + 20μl of sample buff. + 40μl of sample
Prot C
Prot C R1 50 μl
Prot C R2 50 μl
90 μl: 90μl of diluent + 90 μl: 90μl of diluent +
Diluent
10μl of sample 10μl of sample
Prot S R1 30 μl
Prot S
Prot S R2 30 μl
Prot S R3 30 μl
Prot S R4 30 μl
Lupus DRVVT
Lupus screen 75 μl
Screen
Lupus DRVVT
Lupus confirm 75 μl
Confirm

Review instructions for preparation of reagents on the respective Instructions for Use
present in each kit.

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 injec-
tions Volumes of 50 to 200μl for the sample and reagent injections

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5. User Interface

This section provides a complete screen by screen walkthrough of the software’s User Interface
(UI) in order to fully orient the user.

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.

5.1. Software general introduction

5.1.1. Start-up Screen
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.

5.1.2. Top Bar

The Top Bar is always visible, regardless of the location in the software.

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5.1.3. Analysis button

The Analysis button opens the window where testing can be performed.

BUTTON DEFAULT / ACTIVE STATUS SELECTED / INACTIVE STATUS DESCRIPTION / USE FORMAT

Analysis Where analyses

Button
Window can be carried out.

5.1.4. Results button

The Results button opens the Results Window which allows for the detailed review of data col-
lected 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 con-
nected to instrument) and alarms.

BUTTON DEFAULT / ACTIVE STATUS SELECTED / INACTIVE STATUS DESCRIPTION / USE FORMAT

calls for results

Results
screen including Button
window
reaction curves

5.1.5. Quality Control button

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 / ACTIVE SELECTED / INACTIVE
BUTTON DESCRIPTION / USE FORMAT
STATUS STATUS

calls for all commands and windows

linked with Quality Controls (QC),
Quality from creating new lots of controls,
Button
control entering expected values, reviewing
quality control results and data,
statistical analysis, etc...

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5.1.6. Calibration button

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 / ACTIVE SELECTED / INACTIVE

BUTTON DESCRIPTION / USE FORMAT
STATUS STATUS

Calls all commands and windows

linked with calibrations where
Calibra-
reagents and calibrators lots are Button
tion
created, calibration values are
entered and saved.

5.1.7. Configuration button

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 / ACTIVE SELECTED / INACTIVE

BUTTON DESCRIPTION / USE FORMAT
STATUS STATUS

Configu- calls the Configuration of the

Button
ration methods

5.1.8. System button

The System button opens the system parameters. It includes Global, running menu, Printer, LIS
and a protected access to Service.

All these windows will be detailed in their specific sections.

DEFAULT / ACTIVE SELECTED / INACTIVE
BUTTON DESCRIPTION / USE FORMAT
STATUS STATUS

System calls for the system parameters Button

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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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5.2. Calibration
5.2.1. Introduction

Calibration is a procedure to standardize the analyser/method by determining the analyser´s re-

sponse to reference values in the calibration material. To ensure that the results of the measure-
ment of patient samples are correct, perform regular calibration of the analyser. Calibration test
does not need to be done daily, but due to changes in the system environment: batch of reagent
and/or calibrator, the system does not give the expected response.
To ensure the correctness and accuracy of the instrument it is recommended to use reagents and
calibrators supplied by the manufacturer. Store and use the calibrator and reagents following the
instructions for use of the calibrations and reagents. Follow the instructions given in the instruc-
tion for use when preparing and using the calibrator.

5.2.2. Calibration material

For calibration for some method on ECL 412 is intended this calibration material:
• Erba Standard Plasma, Cat. No. EHL00012
• Erba DDimer Calibrator, Cat. No. EHL00018, EHL00044 or calibrator in pack Erba DDimer R,
Cat. No. EHL00049
• Erba PT-INR Multical, Cat. No. EHL00013

5.2.3. Running Calibration

Running Calibration on the ECL 412 requires to enter the name lot numbers and expiration of the
products used, then enter the raw results of the calibrators.

To perform this:
1. Go to Calibration, click on the Calibration button

2. Select the group in which your test is organized

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3. Then click on the button of the test

4. Click on the Calibrate button, the following window opens

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 informa-
tion 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

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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 analyser´s responses
11. Go back to the calibration and go to the second page

12. Enter the Target and analyser responses for the different units
13. Then Save

For some calibrations it is possible to view the Calibration curve, see 5.5.1. for more
details

It is possible to keep 2 different calibration curves per parameter if they are for 2 differ-
ent 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.

5.3. Quality Controls

5.3.1. Introduction
Quality Control (QC) consists of strategies and procedures that measure the precision and stabil-
ity of the analyser. The results imply the reliability of the sample results. QC involves measuring
materials with known, stable characteristics at frequent intervals.

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Erba Lachema recommends running the QC program on a daily basis with normal and abnormal
level controls. A new lot of controls should be analysed in parallel with the current lot prior to
their expiration dates. The measured results should be within the expected range specified by
the manufacturer.

To ensure the correctness and accuracy of the instrument it is recommended to use reagents and
calibrators supplied by the manufacturer. Store and use the controls and reagents by the following
instructions for use of the controls and reagents. Controls beyond their expiration date shall not
be used. Controls (similar to standard plasma samples) must be well mixed before use.

5.3.2. Quality control material

For quality control of some methods on ECL 412 is intended this control material:
• Erba Control N, Cat. No. EHL00014
• Erba Control P, Cat. No. EHL00015
• Erba Control N Plus, Cat. No. EHL00016
• Erba Control P Plus, Cat. No. EHL00017
• Erba DDimer Control N+P, Cat. No. EHL00019
• Erba LA Control High, Cat. No. EHL00039

To fully take advantage of the Quality Control program of the ECL 412, the Quality Control materials
should be defined and identified in the software.
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 5.3.4. Running Quality Control materials
If your Quality Control materials are already defined, but new lots and values need to be entered,
proceed to 5.3.3. step 4 to 7 before going to 5.3.4. Running Quality Control materials

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5.3.3. Defining Quality Control materials

To define Quality Control materials:

1. Click on QC button

2. Click on the Set QC button

3. If the name is not yet set:

a. Open the drop down list of QC names by clicking on the QC Name “button”
b. Select the first generic QC-X line that shows new available QC name positions
c. Click on the SET NAME button

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d. Enter the name of the QC material (up to 14 characters)

e. Press the Enter key to validate and save the name

4. If the name of the QC is already defined, select it from the drop down list

5. Enter the Lot number in the Lot Number field

6. Enter the Expiry date:
a. By clicking on the field the calendar opens

b. By default it opens on today’s date

c. The date can be changed by using the different arrows and clicking on the Day:
• Change the year directly by clicking on the arrow up and down on the Year field and
• Precise the month by using the arrows to the right and left of the currently displayed
month,
• Precise the exact day by selecting the day with your finger
• Click OK to validate the expiry date.

7. Once all the desired Control materials, lots and values are entered, by selecting each assay,
and each unit and saving each time
8. Close by clicking on the close button
9. Now the QC can be run

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5.3.4. Running Quality Control materials

To run Quality Control materials, refer to 5.4. Running analyses.
• At 5.4 step 5 select the Control button

• The following dialogue box opens

Open the name list by clicking on the arrow
Select the name of the desired QC material

Then click on the OK button

• Then proceed to the analysis as instructed in 5.4. from step 7

Quality Control material can be tested in the same run as patient samples

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5.4. Running analyses

Before running analyses, all reagents and samples should be prepared. See Chapter 4 for Analyses
preparation.
1. To run analysis, click on the Analysis button

The following window opens

2. Click on the desired Group of tests (Screening Tests, Factors, D-Dimer or Others)

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

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.

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5.4.1. Running analyses in single or duplicate

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.

5.4.2. Case of clotting tests

Figure 7: Analysis screen for Clotting (PT), configured in single determination

Figure 8: Analysis screen for Clotting (PT), configured in duplicate

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5.4.2.1. Case of Immuno-Turbidimetric tests

Figure 9: Analysis screen for Immunoturbidimetric (D-Dimer), configured in single

Figure 10: Analysis screen for Immunoturbidimetric (D-Dimer), configured in duplicate

5.4.2.2. Case of Chromogenic tests

Figure 11: Analysis screen for Chromogenic (AT III), configured in single

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Figure 12: Analysis screen for Chromogenic (AT III), configured in duplicate

6. Click on the ADD ID field, the following Dialogue box opens

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

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9. Then the system prompts to ADD TUBE with blinking Green/Grey border. Place a clean empty
Erba reaction Cuvette in the prompted channel

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

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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

14. When the incubation time is reached (0) then:

• the system beeps 5 times to prompt the user to get ready to inject
• the button frame blinks from orange to White
• the time is now displayed in Red counting up to display the number seconds exceeding
the prescribed incubation.

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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 Meas-
urement 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 meas-
urements 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

19. The result is automatically printed if a paper roll is inserted and the result displayed in the
table above the channels.

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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.

5.4.3. Running analyses with Preparation line activated

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

• The bottom status corresponds to the measuring channel

• The one above corresponds to the preparation line.

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

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,

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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.

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.

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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 prepa-
ration to avoid over incubation errors

5.5. Retrieving results

5.5.1. Retrieving Calibration results
The results of a calibrator is visible at the time of running the test as a sample in the Analysis sec-
tion, or in the Result later section (see 5.5.3. for more details).

The Calibration curve and data can be viewed in:

1. Click on Calibration

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2. Select the Group in which the assay you intend to view is organized

3. Click on the Assay button name

4. To view the calibration curve:

5. Click on CHART button

• The line C corresponds to the theoretical calibrators values

• The R line corresponds to the Response of the analyser (Clotting in sec, signal in Delta OD,
etc, depending on the assay)
• The Calc. line corresponds to the recalculated value of the response using the calibration
equation used

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• The Graph represents the fitting of the data points using the calibration fitting selected in
the method parameters.
• The data can be printed by clicking on the PRINT button

The data can also be reviewed from the input window

• The data can also be reviewed from the input window

• Click on Calibrate
• Go to next page to view the page 2 where the results are recorded and seeable

5.5.2. Retrieving Quality Control results

Results of Quality Controls can be seen during the run in the table displayed above the measuring
channels (and preparation line when applicable) status.

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

2. Select the appropriate result intended

• Select the Assay name
• Select the QC material
• Select the desired unit

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Figure 13: QC table form view

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
• The result can be printed by clicking on the button
• Or sent to the LIS by clicking on
• 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

4. Review Levey Jennings

Once the Assay Name, QC material and desired units are selected:
5. Click on the LEVEY JENNINGS button

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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.

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

7. It is possible to reject a QC data point from the statistical calculations:

• Click on the data point representation on the graph

• 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
• Click on the waste basket icon to ignore the point

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• Click on the paper sheets icon to integrate it

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.

5.5.3. Retrieving sample results

The results are automatically printed when completed and can be viewed directly from the analysis
menu at the time on testing, either directly from the channel or from the table. Refer to running
analyses 5.4.

To review the stored results at a later time, then:

1. Click on the RESULT button

2. The results can be reviewed in the table

The results from the table show:

• Black letters on white background (within normal no alarm)
• Red letters on white background (abnormal results, no reaction alarm)
• Black letters on Red background (presence of reaction alarm)

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A. Results can be highlighted by clicking on 1 line

B. Results can be selected (ticked) by pressing for a few second on 1 line, then the tick mark ap-
pears in the Sel(ection) column

C. Results can be printed:

1. Click on the Print button
2. Then choose which results to be printed from
• Selected
• Checked (ticked)
• Not printed
• All

D. Results can be sent to LIS:

1. Click on the send button
2. Then choose which results to be sent from
• Selected
• Checked (ticked)
• Not sent
• All

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E. Results can be deleted:

1. Click on the delete button
2. Then choose which results to be deleted from
• Selected
• Checked (ticked)
• All

F. More details can be reviewed by clicking on the DETAILS button

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.

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• The result can be printed by clicking on the button

• Or sent to the LIS by clicking on
• 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).

Figure 14: Example of a reaction curve

• 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

G. The table can also be filtered:

1. Press the FILTERS button
2. The Filters dialogue box opens

3. Filtering can be done by ID, ASSAY and/or DATE

• Click in the ID field and the Virtual Keyboard will automatically open

i. Enter the ID you wish to review

• Click in the ASSAY button and select the assay from the whole assay list

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• Click in the DATE field and the Calendar dialogue box will open

i. Fill the date information as required.

• Activate the filter(s) by clicking on the desired button(s)
Selected items will be displayed in Orange buttons as seen below.

Figure 15: Filters with Assay + Date selected

• Click OK to view the filtered list

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5.6. Configuration (of Assays)

In the Configuration menu, all methods (also referred as assays or tests in this manual) and their
parameters are stored.

5.6.1. Creating new method

New methods can be created on the ECL 412. To create a new method:
1. Click on the Configuration button

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

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4. Type the name of the new desired method (Maximum 14 characters) and press the Enter key

The window goes back to the previous screen

5. Select the group name where you wish to place the new method, as shown below

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,
• click on the group name where it is organized,
• click on the assay name, and
• go to METHOD PARAMETERS. See 5.6.3. for instructions.

5.6.2. Deleting existing method

It is possible to deleting user defined methods. Deleting a method will delete of its related data.

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To do so:

1. Click on the Configuration button

2. Click on the name group where the method to be deleting is organized.

3. Then click on the method name that needs to be deleted

4. Then click on the DELETE METHOD button

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 dis-
carded and lost. Are you sure you want to delete this method?” YES/NO

5. Select the Confirmation decision:

• Click on NO to cancel, the method and all linked data will be kept intact
• Click on YES to confirm deletion.

5.6.3. Method parameters

The method parameters are what defines a method: Type of Measurement, replicate, steps, cali-
bration type, units, normal values, etc.

To review or modify parameters:

To do so:
1. Click on the Configuration button

2. Click on the name group where the method to be reviewed or modified is organized.

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3. Then click on the METHOD PARAMETERS button, the following window opens

4. Fill in the information present in page 1/2 of the method parameters:

• Type of measurement:
• Clotting
• Chromogenic
• Turbidimetric
• Algorithm:
• 50% (50% intercept from Minimum and Maximum light intensity) for clotting tests
• Best fit (steepest slope of the reaction curve) for Clotting tests
• Best fit APTT
• Best fit Fine
• Fibrinogen (for Clotting tests)
• dOD (Delta Absorbance for turbidimetric and Chromogenic assays)
• Duplicate
• ON / OFF
• If ON the replicate limits in % needs to be entered
• The steps definition:

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 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).

• Sample
• Reagent
• Reagent 1
• Reagent 2
• Reagent 3
• Reagent 4
• Diluent
• Buffer
• Latex

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• Then the measurement timing definition
• Min read time (corresponds to the minimum time of measurement for a clotting time or
the First measurement for a Chromogenic or turbidimetric assay)
• Max. read time (corresponds to the maximum time of measurement for a clotting time or
the Second measurement for a Chromogenic or turbidimetric assay)
• 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:

• Units: Enter up to 3 units per assay

• Sec
• %
• INR
• INR calib
• Ratio

• g/L
• mg/dL
• mg/L
• ng/mL
• μg/mL
• μg FEU/mL

All the units in the frame 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

• For each unit select the reporting format (decimal format 9, 9.9; 9.99)
• Enter the Normals and limits of the method
• Normal values (Min – Max)
• Sensitivity limit of the method
• Linearity limit of the method
All expressed in the main unit selected above

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• Then select the type of calibration curve

• Lin-Lin (regression linear of all points on the the 2 linear axes)
• Lin-Lin p-p (Point to Point on the the 2 linear axes)
• Log-Log (Linear regression of all points on the the 2 Log axes)
• Log-Log p-p (Point to Point on the the 2 Log axes)
• Enter the appropriate correlation factor if needed (correction of AX+B type; by default A=1
and B=0)
• 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.
• Dilution ratio information (will be displayed on the information window from the Analysis
mode)
• 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.

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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Global consists of:

• Date and Time information
• Enter Date by clicking on the Date Field, this will open the calendar dialogue box
• Enter the time by using the Up and Down arrows on the Hour and Minutes, check the 24H
box to display 24H format
• Click on SET to save the date & time information
• Sound level information
• Consists of the scrolling cursor indicating the level of sound for the alarms
• The Mute check box will disable the touch screen clicks
• Brightness Consists of the scrolling cursor indicating the level of light of the display
• Software language selector
• Click on the list to select the desired version

5.7.2. Running Menu

The Running Menu consists of:

• Reagent incubation stirring.
• The stirring of the reagents can be set ON or OFF. This setting is effective for both types
of reagent bottle positions: 37°C and Room temperature.
• Identification:
• Sample ID can be user defined or set automatically by the instrument and auto-incremented.
• Select ON to define manually the sample ID for each channel.
• Workflow:
• A Preparation line can be activated for experienced users, to be able to prepare the next
line while one is being tested.
• Selecting Preparation line ON will change the Analysis window by adding the preparation
line above the measurement channel display as seen below. (see 5.4.2. for more details
on how to operate with the preparation line)

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• RFID:
• When new supply needs to be entered into the system (reaction cuvettes),
• then place the kit orienting the RFID tag next to the RFID logo on the left side of the
instrument
• Click on the RFID button
• A message appears giving a 5 seconds count down for the tag to be read.

• 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.

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• Enter the number of cuvettes you wish to transfer from the tag to the devise
• Then click on the logo (tag to device) to save it
• 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

5.7.3. Printer

The Printer consists of the setting of item to be printed:

• Enter laboratory information in 3 lines
• Click on a line number and the keyboard automatically opens
• Type in the information needed (16 characters per line)
• Press the Enter key to validate the field
• Tick the Device name check box for the information to be printed
• Tick the date and Time check box for them to be printed

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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.
The instrument can be connected 2 different ways:
1. By serial port (RS232)
2. By Ethernet (RJ45)

Depending on the type of connexion the system needs to be configured accordingly.

Once the LIS window opens by default with Serial connexion option selected, it displays the in-
formation 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 ac-
cess codes.

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6. Maintenance

6.1. Daily
Beginning of day
• Ensure that the instrument is free from any damage
• That the electrical and LIS (if applicable) connections are secure
• Remove dust and or spills from the surface of instrument using water and dry completely.
• Turn ON instrument and wait for temperature 37+/-0.5°C to be reached

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.

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

6.2. Weekly
There is nothing special to be done on a weekly basis.

6.3. Monthly
There is nothing special to be done on a monthly basis.

6.4. Quarterly
There is nothing special to be done on a quarterly basis.

6.5. Annually
There is nothing special to be done on a annually basis.

But depending on the accreditation of the laboratory, if requalification is required the follow ele-
ments should be checked:
1. Measurement elements
2. Temperature controlled elements
3. Stirring function

The following sections 6.5.1. to 6.5.3. are intended for technical service personnel and only as
indications / information for the user.

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6.5.1. Measurement elements checks

With specific cuvettes, the following measuring channels should be checked.
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.

6.5.1.1. Checking the Nephelometric measurements

The 4 channels are equipped with Red LED to obtain the nephelometric measurements.
Using the service menu the engineer will read the AD values of all 4 channels using 2 different
reference cuvettes.
• 830 S reference cuvette, required AD range in all channels: 280 – 470.
• 450 S reference cuvette, required AD range in all channels: 1275 – 2125.

6.5.1.2. Checking the InfraRed measurements

The Channels 1 and 4 are also equipped with Infrared LEDs to read at 800nm.
Using the service menu the engineer will read the AD values of all Channels 1 & 4 using an IR
filtered glass reference cuvettes.
• Required AD range in both channels: 1085 – 1715.

6.5.1.3. Checking the UV measurements

The Channels 2 and 3 are also equipped with UV LEDs to read at 405nm.
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.

6.5.2. 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.

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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.

6.5.3. Stirring function checks

Under the service program the service engineer will verify that the stirring is functional by insert-
ing a magnetic rod in a bottle in both bottle positions.

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7. Troubleshooting
7.1. Diagnostics Chart
Use the following Diagnostics Chart to help diagnose issues with your instrument so that you
can report genuine technical service problems in way which will help your technical service team
resolve the issue as soon as possible.

Observation Meaning / Check the Following

Critical alarm
Device is overheated! • Turn off and unplug the instrument and all the power supply elements
• Contact your technical service
Instrument
Switching ON the instrument • Insure that the power supply unit and its wires are free of damage
does not start the instrument • 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 • Go to System, Global and check that the system is not on Mute
give a signal beep for starting • See 5.7.1. System, Global
reactions
Error messages
Out of range The QC result is out of the acceptable range as defined in QC lot/Values
• Check QC material (stability for assay, reconstitution)
• Check reagents (stability for assay, reconstitution)
• Replace reagents and QC and retest
Out of normal value The test result is out of the normal range as defined in method confi-
guration
> linearity The test result is out of the linearity limit of the method
• Rerun the test with a greater dilution
< sensitivity The test result is lower than the sensitivity limit of the method
• Rerun the test with a lower dilution
No clotting detected • Check sample for integrity (no clot, hemolysis, lipemia, possible conta-
mination with anticoagulant)
• Verify that the sample and reagent(s) were dispensed correctly (no
bubbles present and correct total volume)
• Check reagents (stability for assay, reconstitution)
• Review reaction curve to check if a reaction has taken place
• Retest sample
• A weak reaction could be due to a low fibrinogen concentration or fac-
tor deficiency or inhibitors
• Review previous patient history
• Review clinical data for the patient
• Review other results for the patient to evaluate the validity of the result
• Proceed with alternate laboratory protocol

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Observation
Clotting time too low
The difference in duplicate
measures is too high
A reagent has expired
Test alert!
Wrong minimum value!
Wrong maximum value!
No more available test!
There is no more free space in The new test name can no longer be inserted in the selected group
this group!
RFID writing failed!
Not enough cuvettes left!
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Meaning / Check the Following
The test result is lower than the minimum reading limit of the method
• Check sample for integrity (no clot, hemolysis, lipemia, possible conta-
mination with anticoagulant)
• Verify that the sample and reagent(s) were dispensed correctly (no
bubbles present and correct total volume)
• Check reagents (stability for assay, reconstitution)
• Review reaction curve to check for abnormalities
• Retest sample
The difference between the replicate measurements exceeds the tole-
rance limit defined in Method, Duplicate Limit
• Retest sample
• Check the information area to see which reagent is expired (and/or the
calibrate window to review the lots)
• Replace reagent by non-expired one before testing
The number of test left for this assay (or cuvette supply) has come below
the defined limit
• Make sure additional supply is available (otherwise place order)
• Use up the remaining tests
• Then add supply through RFID (Be careful, inserting a new RFID supply
will reset the supply so leftover assays will be lost if performed too early)
When programming QC values for a lot, the minimum value is greater
than the maximum
• Correct minimum (and/or maximum) value before saving
When programming QC values for a lot, the Maximum value is lower
than the Minimum
• Correct Maximum (and/or minimum) value before saving
The test or cuvette supply is totally depleted
• Add supply through RFID
(the limit of number of methods has been reached for this group)
• Select another group to insert it in,
• Or delete unused user-defined methods to free up space
The instrument was not able to write in 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
The number of cuvettes does not allow the number of requested tests.
• Limit the batch to the number of possible tests
• Then add supply through RFID (or add new supply But be careful, inser-
ting a new RFID supply will reset the supply so leftover tests will be lost if
performed too early)
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ECL 412

Observation Meaning / Check the Following

The QC is expired! • Start a new lot of non-expired QC before testing
The minimum read time • Correct the inputted information
cannot be smaller than the lag
time!
The minimum read time can- • Correct the inputted information
not be bigger than the maxi-
mum read time!
The maximum read time • Correct the inputted information
cannot be smaller than the lag
time!
The maximum read time • Correct the inputted information
cannot be smaller than the
minimum read time!
The lag time cannot be bigger • Correct the inputted information
than the minimum read time!
The lag time cannot be bigger • Correct the inputted information
than the maximum 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 anten-
na (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 ele-
ments
• Contact your technical service

This section is currently not complete.

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8. Performance
Performance characteristics are given in the instruction for use of individual coagulation kits.

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9. LIS Setup

9.1. General
The ECL412/105 System is linkable to a LIS (Laboratory Information System).

For that you will need to:

• Physically connect the ECL412/105 System to the laboratory system
• Configure the ECL412/105 System

Connection may be done either by serial port or network connection.

Serial Port / Network

ECL412/105 LIS (host)

Results

9.2. Hardware configuration

The connection uses a RS 232 serial interface with DB-9 connector for Serial communication or
Ethernet interface RJ45 connector between the ECL412/105 System and the Host computer.

9.2.1. Serial communication

The connection uses a RS 232 serial interface with DB-9 connector

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9.2.1.1. Cable specifications

RS232 Pin Assignments (DB9 PC signal set) Data:

Received Line Signal Detector (Data

Pin 1 Low level:
Carrier Detect) (DCD)
+5 +20 V
Pin 2 Received Data (RD)
Pin 3 Transmit Data (TD) High level:
-5 -20 V
Pin 4 Data Terminal Ready (DTR)

Pin 5 Signal Ground

Control:
Pin 6 Data Set Ready (DSR)

Pin 7 Request To Send (RTS)

Pin 8 Clear To Send (CTS)

Pin 9 Ring Indicator

9.2.1.2. 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).

9.2.2. Network communication

The network connection is done by plugging an Ethernet RJ 45 Category 5 cable connector to the
network connector of ECL412/105.

To configure the network, contact ERBA Lachema support.

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9.3. Work mode

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.

9.4. 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).

9.4.1. Physical protocol: ASTM 1381

The frame format is:

<STX><Frame #><Data><ETX><Checksum><CR><LF>

(for more information about this protocol, visit www.astm.org)

The function schematics are resumed in the next page.

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START

Wait receiving ENQ

ENQ Received
5 seconds

EOT received
Send ACK File recep on complete

N New files in Wait Frame recep on

\ASTM\OUT
folder? Frame recep on

S Frame analysis

S N
Send NAK
Frame OK?

Connec on Established

Send ENQ
NAK ACK Other file to send?
Received Received
10 seconds
Send EOT – file completed
Send Frame N
n > nb frames of the file =>
Move in \ASTM\OUT\Done
ACK NAK TimeOut 5s folder
Received received
Completed

n=n+1

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9.4.2. Logical protocol: ASTM E 1394

The Logical protocol ASTM E 1394 allows communication between LIS and ECL412/105 System:
Send the results

(for more information about this protocol, visit www.astm.org)

9.4.3. 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 result message is composed of:

a H line (header)
a P line (patient)
one O line or more (order)
for every O line , one R line (result)or more
a L line (end of message)

Example:

H|\^&|||||||ECL_412
P|1||1
O|1|1||^^^Fibriogen|||||
R|1|^^^Fibriogen|34.884365|Sec||||||||20150625162726||
L|1

Sending several results:

When the transmission of several results of an analysis is needed (for example, PT with seconds,
percent and INR):
For a PT Test transmission will be:

3 results lines are sent with the same code (PT)

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:
Field Contens Remarque/Valeur
H řádek
Field n°1:
st
1 character H
st
2 character Field delimiter generally: |
3st character Repetition delimiter generally: \
st
4 character Component delimiter generally: ^
5st character Escape character generally: & but unused
2==>7 Unused fields
8 Automate ID ECL_412 or ECL_105
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:
component # 1,2,3: unused
component # 4: Analysis parameters
6-10 Unused fields
Ligne R
1 R
2 Sequence number
3 Analysis parameters:
component # 1,2,3: unused
component # 4: Analysis parameters
4 Result
5 Unit
6-12 Unused fields
13 Date/time completion Format YYYYMMDDHHMMSS
14-15 Unused fields
L Line
1 L
2 Sequence number

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10. Disposal

Before disposing the instrument, please contact the local Erba Lachema representative. Full in-
struction will be provided for instrument proper and complete disposal process in compliance of
local and national regulations.

Dispose of all liquid waste in accordance with local and national regulations. Liquid waste pre-
treatment is recommended.

A lithium battery is integrated on one internal electronic board.

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11. Packaging

11.1. Transport requirements

Transport Environment limit ranges

Temperature: 5–40°C
Humidity: 5–90 % (non-condensing)
Shock: < 35G

11.2. Packaging labels

The labels applied on the external packaging specify the environmental conditions acceptable for
transportation and storage of the device, as described in this manual.
They also contain necessary labels for the package to be handled appropriately during transports
like FRAGILE, this side up, etc. as needed, according to internal procedures.

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12. Contact

For customer and technical support:

Manufacturer:
Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ
Tel: +420 517 077 111
www.erbamannheim.com

Contact your local technical support:

service@erbamannheim.com

Any serious incident that has occurred in relation to the device shall be reported to the manufac-
turer and the competent authority of the Member State in which the user and / or the patient is
established.

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 Erba Lachema s.r.o.
Karásek 2219/1d, 621 00 Brno, Czech Republic
Tel.: +420 517 077 111
E-mail: diagnostics@erbamannheim.com
www.erbamannheim.com