ECL 412 Đông Máu

ECL 412
Software Version 1.0
Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ

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ECL 412 User Manual | Revision 1.0
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:
Revision Description Date Signed

1.0 Initial Release 16-09-2015 Corinne Robe
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Icons
The following icons are used on the instrument to aid the user:
Attention: Read the installation document
Read the instructions carefully before attempting

Information:
practically.
Be aware that this product poses some biological risk due to

the nature of the material it analyses.
Biological Risk:
Take appropriate pre-cautions noted in this User Manual
below.
Storage
Store this instrument at between 5°C and 20 °C
Conditions:
IVD: This instrument is covered by the European In Vitro

Diagnostics Directive.
CE Mark: This product is CE marked.
Manufacturer: Erba Lachema s.r.o., Czech Republic
Serial Number: Denotes the product serial number.
The symbol on the product indicates that this product may

not be treated as a household waste. Instead it shall be
handled to the applicable collection point for the recycling of
Disposal:
electrical and electronic equipment. By ensuring this product
is disposed of correctly, you will help prevent potential
negative consequences for the environment and human
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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:
Please pay special attention to notices with this mark.

There is potential for risk to the operator or instrument
safety.
1. Warning messages Black on White displays
important user information to give elements to
make informed decisions
Warning:
2. Warning messages Black on Orange displays
important information that can lead to some
degree of system inconvenience
3. Warning messages White on Red displays
important massages that can lead to damages to
the instrument or potential danger to the user
Note: This point is worthy of note.
Read the instructions or kit insert sheets carefully before

Information:
attempting practically.
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.
Biohazard:
Consider all human-source materials, like controls and
calibrators, as potentially infectious.
Dispose of all liquid waste in accordance with local and

national regulations. Liquid waste pre-treatment is
recommended.
Store the instrument between 5°C and 20°C. Pay attention

Storage: to other recommended storage temperatures on associated
product literature.
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1. Contents
1
PREFACE ________________________________________________________________________ 3
REVISIONS _______________________________________________________________________ 4
ICONS __________________________________________________________________________ 5
1. CONTENTS ___________________________________________________________________ 8
2. OVERVIEW __________________________________________________________________ 12
2.1. GENERAL DESCRIPTION _________________________________________________________ 12

2.2. INTENDED USE _______________________________________________________________ 12
2.3. INSTRUMENT SPECIFICATIONS _____________________________________________________ 13
2.4. DEVICE PRESENTATION _________________________________________________________ 15
2.4.1. MODULE POSITIONS __________________________________________________________ 15
2.4.2. MODULE DESCRIPTION ________________________________________________________ 16
2.4.3. COLOUR TOUCH SCREEN _______________________________________________________ 16
2.4.4. BUILT-IN THERMAL PRINTER _____________________________________________________ 16
2.4.5. 37°C TEMPERATURE CONTROLLED AREA _____________________________________________ 16
2.4.5.1. MEASURING CHANNELS ______________________________________________________ 16
2.4.5.2. REACTION CUVETTES INCUBATION AREA ___________________________________________ 16
2.4.5.3. 37°C REAGENT INCUBATION AREA _______________________________________________ 16
2.4.6. AMBIENT TEMPERATURE REAGENT INCUBATION AREA ____________________________________ 17
2.4.7. REAGENT STIRRING DEVICE______________________________________________________ 17
2.4.8. RADIO FREQUENCY IDENTIFICATION (RFID) __________________________________________ 17
2.4.9. INTERFACE_________________________________________________________________ 17
2.4.9.1. ON/OFF SWITCH __________________________________________________________ 17
2.4.9.2. EXTERNAL POWER SUPPLY ____________________________________________________ 17
2.4.9.3. SERIAL PORT ______________________________________________________________ 17
2.4.9.4. USB PORTS TYPE A _________________________________________________________ 17
2.4.9.5. USB PORT TYPE B __________________________________________________________ 18
2.4.10. INSTRUMENT IDENTIFICATION LABEL ______________________________________________ 19
2.4.11. ECL 412 ACCESSORIES LIST ____________________________________________________ 19
3. OPERATING PRINCIPLES _______________________________________________________ 20
3.1. DETERMINATION OF CLOTTING TIMES _______________________________________________ 20

3.2. CHROMOGENIC MEASUREMENTS___________________________________________________ 20
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3.3. IMMUNO-TURBIDIMETRIC MEASUREMENTS ___________________________________________ 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
4.3.2. SPECIFIC SAMPLE PREPARATION __________________________________________________ 24
4.3.3. PREPARATION OF CALIBRATORS __________________________________________________ 24
4.4. 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 ___________________________________________________________ 27
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. RUNNING CALIBRATION _________________________________________________________ 31
5.3. RUNNING QUALITY CONTROLS ____________________________________________________ 33
5.3.1. DEFINING QUALITY CONTROL MATERIALS ___________________________________________ 33
5.3.2. RUNNING QUALITY CONTROL MATERIALS ___________________________________________ 36
5.4. RUNNING ANALYSES ___________________________________________________________ 37
5.4.1. RUNNING ANALYSES IN SINGLE OR DUPLICATE _________________________________________ 38
5.4.1.1. CASE OF CLOTTING TESTS _____________________________________________________ 39
5.4.1.2. CASE OF IMMUNO-TURBIDIMETRIC TESTS __________________________________________ 39
5.4.1.3. CASE OF CHROMOGENIC TESTS _________________________________________________ 40
5.4.2. RUNNING ANALYSES WITH PREPARATION LINE ACTIVATED _________________________________ 45
5.5. RETRIEVING RESULTS ___________________________________________________________ 48
5.5.1. RETRIEVING CALIBRATION RESULTS _______________________________________________ 48
5.5.2. RETRIEVING QUALITY CONTROL RESULTS ____________________________________________ 49
5.5.3. RETRIEVING SAMPLE RESULTS ___________________________________________________ 52
5.6. CONFIGURATION (OF ASSAYS) ____________________________________________________ 56
5.6.1. CREATING NEW METHOD ______________________________________________________ 56
5.6.2. DELETING EXISTING METHOD ____________________________________________________ 59
5.6.3. METHOD PARAMETERS ________________________________________________________ 60
5.7. SYSTEM ____________________________________________________________________ 64
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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
6.1. SITE PREPARATION ____________________________________________________________ 71

6.2. SYSTEM PREPARATION _________________________________________________________ 71
6.2.1. UNBOX THE SYSTEM __________________________________________________________ 71
6.2.2. PREPARE THE SYSTEM FOR INSTALLATION ____________________________________________ 72
6.2.3. INSTALL PAPER ROLL __________________________________________________________ 73
6.2.4. PRECAUTION GUIDE __________________________________________________________ 74
7. MAINTENANCE ______________________________________________________________ 76
7.1. DAILY _____________________________________________________________________ 76

7.2. WEEKLY____________________________________________________________________ 76
7.3. MONTHLY __________________________________________________________________ 76
7.4. QUARTERLY _________________________________________________________________ 76
7.5. ANNUALLY __________________________________________________________________ 76
7.5.1. MEASUREMENT ELEMENTS CHECKS________________________________________________ 77
7.5.1.1. CHECKING THE NEPHELOMETRIC MEASUREMENTS ____________________________________ 77
7.5.1.2. CHECKING THE INFRARED MEASUREMENTS_________________________________________ 77
7.5.1.3. CHECKING THE UV MEASUREMENTS _____________________________________________ 77
7.5.2. VERIFICATION / RECALIBRATION OF TEMPERATURES ____________________________________ 78
7.5.3. STIRRING FUNCTION CHECKS ____________________________________________________ 78
8. TROUBLESHOOTING __________________________________________________________ 79
8.1. DIAGNOSTICS CHART ___________________________________________________________ 79
9. PERFORMANCE ______________________________________________________________ 83
9.1. PRECISION __________________________________________________________________ 83

9.2. LIMITS _____________________________________________________________________ 84
10. LIS SETUP __________________________________________________________________ 86
10.1. GENERAL __________________________________________________________________ 86

10.2. HARDWARE CONFIGURATION ____________________________________________________ 86
10.2.1. SERIAL COMMUNICATION _____________________________________________________ 87
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10.2.1.1. CABLE SPECIFICATIONS______________________________________________________ 87

10.2.1.2. ECL412/105 RS232 CONNECTION ____________________________________________ 88
10.2.2. NETWORK COMMUNICATION___________________________________________________ 88
10.3. WORK MODE _______________________________________________________________ 89
10.4. PROTOCOLS ________________________________________________________________ 89
10.4.1. PHYSICAL PROTOCOL: ASTM 1381 ______________________________________________ 89
10.4.2. LOGICAL PROTOCOL: ASTM E 1394______________________________________________ 91
10.4.3. RESULTS _________________________________________________________________ 91
11. DISPOSAL __________________________________________________________________ 95
11.1. END OF LIFE DISPOSAL _________________________________________________________ 95
12. PACKAGING ________________________________________________________________ 96
12.1. TRANSPORT REQUIREMENTS _____________________________________________________ 96

12.2. PACKAGING LABELS ___________________________________________________________ 96
13. CONTACT __________________________________________________________________ 97
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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
2.1. General Description

The Erba Mannheim ECL 412 Analyzer 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

The ECL 412 Analyzer is intended for in-vitro measurement of hemostasis parameters like:
Assay Volume Predilution Volume of Number Volume of reagents

of pure of the diluted of required
sample sample sample reagents
required (when
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
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Assay Volume Predilution Volume of Number Volume of reagents

of pure of the diluted of required
sample sample sample reagents
required (when
applicable)
Intrinsic factors: Fact 8µl 1/5 40µl 3 40+40+40

VIII, 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)
2.3. Instrument specifications

ECL 412 is a:
o 4 channel semi-automated haemostasis instrument

o It can perform 4 simultaneous tests of the same parameter
o It is also possible to have a second row of assay preparation/incubation during the analysis
of the current line
o It can run assays in single or duplicate (programmable per assay).
o Optically detects and automatically moves to the next assay steps and auto starts the
measurements
Tests principles:
o Clotting (scattered light at 640nm)

o Chromogenic (colorimetry at 405nm)
o Immuno-turbidimetric (turbidimetry at 800nm)
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See Chapter 3 for details of operating principles.
Dimensions / Weight:
o Dimension : 300 x 290 x 90 mm

o Weight : 3 kgs
Environmental requirements:
o Operating Temperature : 17-32°C

o Humidity : Max. 80% Relative Humidity, non-condensing
Power:
o Power Supply : 100-240 VAC and 50/60 Hz

o Power Consumption : 45 Watts
o In-Rush Power : 150VA or less
Calibrations:
o Up to 6 calibration levels per assay

o Storage of the active calibration curve
Quality Controls:
o Up to 12 different control names total can be assigned to any given assay.

o Automatic Levey-Jennings plotting
o Automatic statistics calculation
o Storage of Quality Control results
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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2.4. Device presentation

2.4.1. 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

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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Figure 3: ECL 412 rear view
2.4.2. Module Description
2.4.3. 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.
2.4.4. Built-in thermal printer
The device is a 2 inches integrated thermal printer. It prints automatically and/or on demand
results and other information.
2.4.5. 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.
2.4.5.1. 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
2.4.5.2. Reaction cuvettes incubation area
This area is composed of 20 positions (4 columns of 5 cuvette holes, aligned with the
measurement channels). It can hold the reaction cuvettes.
2.4.5.3. 37°C reagent incubation area
This area is composed of a total of 7 reagent positions:
 1 position for a 30 mm diameter vial (or 22 to 24 mm diameter with adaptors). This

position is equipped with a stirring device.
 6 positions for 3ml cups for reagent incubations
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2.4.6. 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
2.4.7. 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 deactivated
from the System (running mode) section of the software. This activation / deactivation is common
for the 37°C and ambient reagent positions.
2.4.8. 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.
2.4.9. Interface
At the back and on the side of the ECL 412 a number of connections and buttons are present.
2.4.9.1. ON/OFF switch
This switch is used to turn the instrument ON and OFF.
2.4.9.2. External Power Supply
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.
2.4.9.3. Serial Port
The Serial port is a RS232 9 pin connector for serial communication to the LIS.
2.4.9.4. 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
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curves, which can be viewed when checking details in the Results.
2.4.9.5. USB port type B
A slave USB port is present and can be used.
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2.4.10. Instrument identification label
Figure 4: ECL 412 identification label for India (a), for the rest of the world (b)
2.4.11. ECL 412 Accessories list
The ECL 412 analyser is delivered with the following accessories:
Item Quantities
ECL 412 Analyzer 1
External universal power supply 1
External power cord 1
Instrument dust cover 1
Stylus 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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3. Operating Principles
3
The ECL 412 uses optical detection for 3 types of analyses:
 Determination of clotting time

 Chromogenic measurements
 Immuno-Turbidimetric measurement
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.
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.
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
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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
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).
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).
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 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
Prot S Diluent + Prot S R1 + R2 + 10 µL 10 µL

R3 + R4 90µl of diluent + 10µl of sample 90µl of diluent + 10µl of sample
Lupus Lupus screen 75 µL
Screen
Lupus Lupus confirm 75 µL
Confirm
4.3.3. Preparation of calibrators

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

Prot C Prot C diluent Calibrator: ref. EHL00012 Erba Standard Plasma
Pure, 1/2 , 1/4 ; resulting in ¼, 1/8, 1/16
Prot S Prot S Saline solution Calibrator: ref. EHL00012 Erba Standard Plasma
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
DRVVT Confirm
4.4. 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.
Parameter Reagent Consumption/Test Consumption for duplicate tests for

dilutions
PT PT Reagent 100 µL
APTT APTT Reagent 50 µL
Calcium Chloride 50 µL
Fbg Owren's Veronal Buffer 180 µL : 270 µL
180µl of buffer +20µl of sample 270µl of buffer + 30µl of sample
Thrombin Reagent 50 µL
TT Thrombin Time Reagent 50 µL
Extrinsic Owren's Veronal Buffer 80 µL :
Factor 80µl of buffer +20µl of sample
PT based Factor-deficient Plasma 40 µL
PT Reagent 80 µL
Intrinsic Owren's Veronal Buffer 80 µL : 80 µL :
Factor 80µl of buffer +20µl of sample 80µl of buffer +20µl of sample
APTT Factor-deficient Plasma 40 µL
based
APTT Reagent 40 µL
Calcium Chloride 40 µL
AT III AT Xa diluted dilution buffer 180 µl dilution in 2 steps: 270 µl dilution in 2 steps:
Dil1= 90µl of buffer + 10µl of sample, Dil1= 90µl of buffer + 10µl of sample,
Dil2= 90µl of buffer + 10µl of Dil1 Dil2= 180µl of buffer + 20µl of Dil1
AT Xa R1 50 µL
AT Xa R2 50 µL
DDimer DDimer Buffer 75 µL
DDimer Latex 60 µL
Prot C Prot C Dilution buffer 60 µL 120 µL
60µl of PC Dil° buff. + 20µl of sample 120µl of PC Dil° buff. + 40µl of sample
Prot C R1 50 µL
Prot C R2 50 µL
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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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5.5 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.
5.1.3. Analysis button
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.
FORMA
T
STATUS STATUS
Results window calls for results screen including Button

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.
FORMA
T
STATUS STATUS
Quality control calls for all commands and Button

windows linked with Quality
Controls (QC), from creating new
lots of controls, 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.
FORMA
T
STATUS STATUS
Calibration Calls all commands and windows Button

linked with calibrations where
reagents and calibrators lots are
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.
FORMA
T
STATUS STATUS
Configuration calls the Configuration of the button

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.
FORMA
T
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. 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
3. Then click on the button of the test
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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.
5.3. Running Quality Controls

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 5.2.2 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
5.3.1. Defining Quality Control materials

To define Quality Control materials:
1. Click on QC button
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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
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
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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:
i. Change the year directly by clicking on the arrow up and down on the Year
field and
ii. Precise the month by using the arrows to the right and left of the currently
displayed month,
iii. Precise the exact day by selecting the day with your finger
iv. 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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5.3.2. 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

o Open the name list by clicking on the arrow
o Select the name of the desired QC material
o Then click on the OK button

 Then proceed to the analysis as instructed in 5.4 from step 7
Note: 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)
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.
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.
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5.4.1.1. 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
5.4.1.2. Case of Immuno-Turbidimetric tests
Figure 9: Analysis screen for Immunoturbidimetric (D-Dimer), configured in single
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Figure 10: Analysis screen for Immunoturbidimetric (D-Dimer), configured in duplicate
5.4.1.3. Case of Chromogenic tests
Figure 11: Analysis screen for Chromogenic (AT III), configured in single
Figure 12: Analysis screen for Chromogenic (AT III), configured in duplicate
6. Click on the ADD ID field, the following Dialogue box opens
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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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14. When the incubation time is reached (0) then:

a. the system beeps 5 times to prompt the user to get ready to inject
b. the button frame blinks from orange to White
c. the time is now displayed in Red counting up to display the number seconds
exceeding the prescribed incubation.
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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
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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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.
5.4.2. 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
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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
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
section, 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
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:
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5. Click on CHART button
a. The line C corresponds to the theoretical calibrators values

b. The R line corresponds to the Response of the analyser (Clotting in sec, signal in
Delta OD, etc, depending on the assay)
c. The Calc. line corresponds to the recalculated value of the response using the
calibration equation used
d. The Graph represents the fitting of the data points using the calibration fitting
selected in the method parameters.
e. The data can be printed by clicking on the PRINT button
Note: 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.
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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
2. Select the appropriate result intended

a. Select the Assay name
b. Select the QC material
c. Select the desired unit
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
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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
4. Review Levey Jennings
Once the Assay Name, QC material and desired units are selected:
5. Click on the LEVEY JENNINGS button
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
7. It is possible to reject a QC data point from the statistical calculations:

a. Click on the data point representation on the graph
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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
c. Click on the waste basket icon to ignore the point
d. Click on the paper sheets icon to integrate it
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.
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
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Note: 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)
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
appears 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
a. Selected
b. Checked (ticked)
c. Not printed
d. All
D. Results can be sent to LIS:
1. Click on the send button

2. Then choose which results to be sent from
a. Selected
b. Checked (ticked)
c. Not sent
d. 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
a. Selected
b. Checked (ticked)
c. 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.
 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
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3. Filtering can be done by ID, ASSAY and/or DATE

a. Click in the ID field and the Virtual Keyboard will automatically open
i. Enter the ID you wish to review

b. Click in the ASSAY button and select the assay from the whole assay list
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.
Figure 15: Filters with Assay + Date selected
e. Click OK to view the filtered list
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
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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
The window goes back to the previous screen
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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5.6.2. Deleting existing method

It is possible to deleting user defined methods. Deleting a method will delete of its related data.
To do so:
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
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
5. Select the Confirmation decision:

a. Click on NO to cancel, the method and all linked data will be kept intact
b. Click on YES to confirm deletion.
5.6.3. Method parameters

The method parameters are what defines a method: Type of Measurement, replicate, steps,
calibration type, units, normal values, etc.
To review or modify parameters:
To do so:
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2. Click on the name group where the method to be reviewed or modified is

organized.
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:

i. Type of measurement:
o Clotting
o Chromogenic
o Turbidimetric
ii. Algorithm:
o 50% (50% intercept from Minimum and Maximum light intensity) for clotting tests
o Best fit (steepest slope of the reaction curve) for Clotting tests
o Best fit APTT
o Best fit Fine
o Fibrinogen (for Clotting tests)
o dOD (Delta Absorbance for turbidimetric and Chromogenic assays)
iii. Duplicate
o ON / OFF
o If ON the replicate limits in % needs to be entered
iv. 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
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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
iv. Then select the type of calibration curve

o Lin-Lin (regression linear of all points on the the 2 linear axes)
o Lin-Lin p-p (Point to Point on the the 2 linear axes)
o Log-Log (Linear regression of all points on the the 2 Log axes)
o Log-Log p-p (Point to Point on the the 2 Log axes)
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
Global consists of:
 Date and Time information

o Enter Date by clicking on the Date Field, this will open the calendar dialogue box
o Enter the time by using the Up and Down arrows on the Hour and Minutes, check
the 24H box to display 24H format
o Click on SET to save the date & time information
 Sound level information
o Consists of the scrolling cursor indicating the level of sound for the alarms
o 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
o Click on the list to select the desired version
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5.7.2. Running Menu
The Running Menu consists of:
 Reagent incubation stirring.

o 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:
o Sample ID can be user defined or set automatically by the instrument and auto-
incremented.
o Select ON to define manually the sample ID for each channel.
 Workflow:
o A Preparation line can be activated for experienced users, to be able to prepare
the next line while one is being tested.
o 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)
 RFID:
o When new supply needs to be entered into the system (reaction cuvettes),
65 | 97
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
66 | 97
5.7.3. Printer
The Printer consists of the setting of item to be printed:
 Enter laboratory information in 3 lines

o Click on a line number and the keyboard automatically opens
o Type in the information needed (16 characters per line)
o 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
67 | 97
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 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.
68 | 97
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.
69 | 97
70 | 97
6. Installation
6
6.1. 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
6.2. System Preparation

The instrument is packed in an inner box, and accessories around it in the outer box
6.2.1. Unbox the system
1 2
71 | 97
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
6.2.2. Prepare the system for installation
 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
72 | 97
6.2.3. 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
73 | 97
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: 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
74 | 97
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 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.
75 | 97
7. Maintenance
7
7.1. 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.
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.
76 | 97
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.
7.5.1. 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.
7.5.1.1. 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.
7.5.1.2. 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.
7.5.1.3. 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.
77 | 97
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.
7.5.3. Stirring function checks

Under the service program the service engineer will verify that the stirring is functional by inserting
a magnetic rod in a bottle in both bottle positions.
78 | 97
8. Troubleshooting
8
8.1. 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 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
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
79 | 97
Observation Meaning
Check the Following

Out of normal value The test result is out of the normal range
as defined in method configuration
> 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
contamination with anticoagulant)
 Verify that the sample and reagent(s)
were dispensed correctly (no bubbles
present and correct total volume)
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
factor 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
Clotting time too low The test result is lower than the
minimum reading limit of the method
 Check sample for integrity (no clot,
hemolysis, lipemia, possible
contamination with anticoagulant)
 Verify that the sample and reagent(s)
were dispensed correctly (no bubbles
present and correct total volume)
reconstitution)
 Review reaction curve to check for
abnormalities
 Retest sample
The difference in duplicate measures is too high The difference between the replicate
measurements exceeds the tolerance
limit defined in Method, Duplicate Limit
 Retest sample
80 | 97
Observation Meaning
Check the Following

A reagent has expired  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
Test alert! 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)
Wrong minimum value! When programming QC values for a lot,
the minimum value is greater than the
maximum
 Correct minimum (and/or maximum)
value before saving
Wrong maximum value! When programming QC values for a lot,
the Maximum value is lower than the
Minimum
 Correct Maximum (and/or minimum)
value before saving
No more available test! The test or cuvette supply is totally
depleted
 Add supply through RFID
There is no more free space in this group! The new test name can no longer be
inserted in the selected group (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
RFID writing failed! 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
Not enough cuvettes left! The number of cuvettes does not allow
the number of requested tests.
81 | 97
Observation Meaning
Check the Following

 Limit the batch to the number of
possible tests
 Then add supply through RFID (or add
new supply But be careful, inserting a
new RFID supply will reset the supply
so leftover tests will be lost if
performed too early)
The QC is expired!  Start a new lot of non-expired QC
before testing
The minimum read time cannot be smaller than  Correct the inputted information
the lag time!
The minimum read time cannot be bigger than the  Correct the inputted information
maximum read time!
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
This section is currently not complete.
82 | 97
9.9 Performance
9.1. Precision
The analyser ECL412 performance were evaluated with the Erba reagents. Results are as follows.
Parameter Reagent Unit C.V. * C.V. limits ** Others

PT LS Erba Protime LS % 2% or less 4.8%
PT Erba Protime % 3% or less 4.8%
APTT Erba Actime sec 2.5% or less 3.9%
Calcium Chloride 25mM
Fbg Owren's Veronal Buffer g/L or mg/dL 5% of less 6.5%
Erba Thrombin Reagent
TT Erba Thrombin Time sec 7% or less 10%
Extrinsic Factor Owren's Veronal Buffer % 8% or less 9%
PT based Erba Factor deficient
Plasmas
Erba Protime or Protime
LS
Intrinsic Factor Owren's Veronal Buffer % 7% or less 8%
APTT based Erba Factor deficient
Plasmas
Erba Actime
AT III Erba Chrom AT Xa % 6% or less 10.7%
DDimer Erba DDimer R ng/mL 6% or less <10% at cutoff LOQ= 30ng/mL

<15% at ½ cutoff Linearity 3 500
No Hook effect till
100 000
Prot C Erba Prot C Dilution % 3% or less 6.7%
buffer
Lupus Erba LA1 Lupus screen sec 4% or less No published
DRVVT Screen limits
Lupus Erba LA2 Lupus confirm sec 3% or less No published
DRVVT Confirm limits
* CV are coefficients of variation obtained from running replicates of 20 Erba Normal controls for
routine tests PT, APTT, and Fibrinogen, and 10 replicates for the other parameters.
**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
83 | 97
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
Parameter Reagent Linearity / Maximum Interferences

reportable reading time
ranges
Lipids Icteria Hemolysis
PT LS Erba Protime LS 0.7 to 10 INR 150 sec No No No
significant significant significant
interference interference interference
until 3 g/L until 200 until 7.5 g/L
mg/L
PT Erba Protime 0.7 to 10 INR 180 sec No No No
until 3 g/L until 200 until 10 g/L
mg/L
APTT Erba Actime 180 sec No No No
Calcium Chloride 25mM significant significant significant
mg/L
Fbg Owren's Veronal Buffer 40 to 490 mg/dL 60 sec No No No
Erba Thrombin Reagent with standard significant significant significant
1/10 dilution, or interference interference interference
35 to 980 with until 10 g/L until 200 until 10 g/L
1/5 and 1/20 mg/L
dilutions
TT Erba Thrombin Time 120 sec No No No
mg/L
Extrinsic Factor Owren's Veronal Buffer 10 to 130% 180 sec Refer to corresponding PT reagent
PT based Erba Factor deficient
Plasmas
Erba Protime or
Protime LS
Intrinsic Factor Owren's Veronal Buffer 10 to 130% 180 sec Refer to corresponding APTT reagent
APTT based Erba Factor deficient
Plasmas
Erba Actime
AT III Erba Chrom AT Xa 15 to 130% 45 sec No
significant
interference
until 10 g/L
84 | 97
Parameter Reagent Linearity / Maximum Interferences

reportable reading time
ranges
Lipids Icteria Hemolysis
DDimer Erba DDimer R LOQ= 30ng/mL 150 sec No No No
Lin.= 3500ng/mL significant significant significant
No Hook effect interference interference interference
till 100000 until 10 g/L until 200 until 8 g/L
mg/L
Prot C Erba Prot C Dilution 0 to 120% 60 sec No
buffer significant
interference
until 60
mg/L
Lupus Erba LA1 Lupus screen 180 sec No No No
DRVVT Screen significant significant significant
mg/L
Lupus Erba LA2 Lupus 120 sec No No No
DRVVT Confirm confirm significant significant significant
mg/L
85 | 97
10. LIS
10 Setup
10.1. 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.
10.2. 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.
86 | 97
10.2.1. Serial communication

The connection uses a RS 232 serial interface with DB-9 connector
10.2.1.1. Cable specifications
RS232 Pin Assignments (DB9 PC signal set) Data:
Received Line Signal Detector Low level:

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

Control:
Pin 5 Signal Ground
OFF:
Pin 6 Data Set Ready (DSR)
+5  +20 V
Pin 7 Request To Send (RTS)
ON:
Pin 8 Clear To Send (CTS) -5  -20 V
Pin 9 Ring Indicator
87 | 97
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).
10.2.2. 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.
88 | 97
10.3. 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.
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).
10.4.1. 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.
89 | 97
START
Wait receiving ENQ
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
90 | 97
10.4.2. 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 )
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 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
91 | 97
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
92 | 97
Fields Table:
Field Contenu Remarque/Valeur
H Line
Field n°1 :
1st character H
2nd character Field delimiter generally : |
3rd character Repetition delimiter generally : \
4th character Component delimiter generally : ^
5th 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
93 | 97
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
94 | 97
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.
Note: A lithium battery is integrated on one internal electronic board.
95 | 97
12 Packaging
12.
12.1. Transport requirements
Transport Environment limit ranges
 Temperature: 5-40°C
 Humidity: 5- 90% (non-condensing)
 Chock: < 35G
12.2. Packaging labels
96 | 97
13 Contact
13.
For customer and technical support:
Manufacturer:
Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ
Tel: +420 517 077 111
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)
97 | 97

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ECL 412

Software Version 1.0

Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ

Revision Description Date Signed

Attention: Read the installation document

Read the instructions carefully before attempting

Be aware that this product poses some biological risk due to

IVD: This instrument is covered by the European In Vitro

CE Mark: This product is CE marked.

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

Serial Number: Denotes the product serial number.

The symbol on the product indicates that this product may

Please pay special attention to notices with this mark.

Note: This point is worthy of note.

Read the instructions or kit insert sheets carefully before

Decontaminate all parts of the instrument before service

Observe appropriate precautions when using this

Dispose of all liquid waste in accordance with local and

Store the instrument between 5°C and 20°C. Pay attention

2.1. GENERAL DESCRIPTION _________________________________________________________ 12

3. OPERATING PRINCIPLES _______________________________________________________ 20

3.1. DETERMINATION OF CLOTTING TIMES _______________________________________________ 20

3.3. IMMUNO-TURBIDIMETRIC MEASUREMENTS ___________________________________________ 20

4. ANALYSES PREPARATIONS _____________________________________________________ 22

4.1. STARTING UP THE INSTRUMENT____________________________________________________ 22

5. USER INTERFACE _____________________________________________________________ 27

5.1. SOFTWARE GENERAL INTRODUCTION ________________________________________________ 27

6.1. SITE PREPARATION ____________________________________________________________ 71

7.1. DAILY _____________________________________________________________________ 76

8.1. DIAGNOSTICS CHART ___________________________________________________________ 79

9.1. PRECISION __________________________________________________________________ 83

10. LIS SETUP __________________________________________________________________ 86

10.1. GENERAL __________________________________________________________________ 86

10.2.1.1. CABLE SPECIFICATIONS______________________________________________________ 87

11. DISPOSAL __________________________________________________________________ 95

11.1. END OF LIFE DISPOSAL _________________________________________________________ 95

12. PACKAGING ________________________________________________________________ 96

12.1. TRANSPORT REQUIREMENTS _____________________________________________________ 96

13. CONTACT __________________________________________________________________ 97

2.1. General Description

2.2. Intended Use

Assay Volume Predilution Volume of Number Volume of reagents

APTT 50µl 2 50+50µl

Fibrinogen 10µl 1/10 100µl 1 50µl

Extrinsic factors: Fact II, 8µl 1/5 40µl 2 40+80

Assay Volume Predilution Volume of Number Volume of reagents

Intrinsic factors: Fact 8µl 1/5 40µl 3 40+40+40

D-Dimer 15µl 2 75+60

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)

2.3. Instrument specifications

o 4 channel semi-automated haemostasis instrument

o Clotting (scattered light at 640nm)

o Dimension : 300 x 290 x 90 mm

o Operating Temperature : 17-32°C

o Power Supply : 100-240 VAC and 50/60 Hz

o Up to 6 calibration levels per assay

o Up to 12 different control names total can be assigned to any given assay.

2.4. Device presentation

1= Colour touch screen