ECL 105 Manual

ECL 105
Software Version 1.0
Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ

ECL 105 User Manual | Revision 1.0
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Preface
The ECL 105 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 105 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 105 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 prescribed use and the instrument maintenance
procedures will void the warranty and may result in injuries.
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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
2.4.2.1. COLOUR TOUCH SCREEN ______________________________________________________ 16
2.4.2.2. BUILT-IN THERMAL PRINTER ___________________________________________________ 16
2.4.2.3. 37°C TEMPERATURE CONTROLLED AREA ___________________________________________ 16
2.4.2.3.1. MEASURING CHANNELS _____________________________________________________ 16
2.4.2.3.2. REACTION CUVETTES INCUBATION AREA __________________________________________ 16
2.4.2.3.3. 37°C REAGENT INCUBATION AREA ______________________________________________ 16
2.4.2.3.4. REAGENT STIRRING DEVICE __________________________________________________ 16
2.4.2.4. AMBIENT TEMPERATURE REAGENT INCUBATION AREA __________________________________ 16
2.4.2.5. RADIO FREQUENCY IDENTIFICATION (RFID) _________________________________________ 17
2.4.2.6. INTERFACE _______________________________________________________________ 17
2.4.2.6.1. ON/OFF SWITCH _________________________________________________________ 17
2.4.2.6.2. EXTERNAL POWER SUPPLY ___________________________________________________ 17
2.4.2.6.3. SERIAL PORT ____________________________________________________________ 17
2.4.2.6.4. USB PORT TYPE A ________________________________________________________ 17
2.4.2.6.5. USB PORT TYPE B _________________________________________________________ 17
2.5. INSTRUMENT IDENTIFICATION LABEL ________________________________________________ 18
2.6. ECL 105 ACCESSORIES LIST ______________________________________________________ 18
3. OPERATING PRINCIPLES _______________________________________________________ 19
3.1. DETERMINATION OF CLOTTING TIMES _______________________________________________ 19
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3.2. IMMUNO-TURBIDIMETRIC MEASUREMENTS ___________________________________________ 19
4. ANALYSES PREPARATIONS _____________________________________________________ 20
4.1. STARTING UP THE INSTRUMENT____________________________________________________ 20

4.2. LOADING OF CONSUMABLES ______________________________________________________ 20
4.3. PREPARATION OF SAMPLES_______________________________________________________ 21
4.3.1. PRE ANALYTICAL PREPARATIONS OF SAMPLES_________________________________________ 21
4.3.2. SPECIFIC SAMPLE PREPARATION __________________________________________________ 22
4.3.3. PREPARATION OF CALIBRATORS __________________________________________________ 22
4.4. PREPARATION OF REAGENTS ______________________________________________________ 23
5. USER INTERFACE _____________________________________________________________ 24
5.1. SOFTWARE GENERAL INTRODUCTION ________________________________________________ 24

5.1.1. START-UP SCREEN ___________________________________________________________ 24
5.1.2. SIDE BAR__________________________________________________________________ 24
5.1.3. ANALYSIS BUTTON ___________________________________________________________ 25
5.1.4. RESULTS BUTTON ____________________________________________________________ 25
5.1.5. QUALITY CONTROL BUTTON _____________________________________________________ 25
5.1.6. CALIBRATION BUTTON _________________________________________________________ 26
5.1.7. SYSTEM BUTTON ____________________________________________________________ 26
5.1.8. STATUS BAR ________________________________________________________________ 27
5.2. RUNNING CALIBRATION _________________________________________________________ 28
5.3. RUNNING QUALITY CONTROLS ____________________________________________________ 31
5.3.1. DEFINING QUALITY CONTROL MATERIALS ___________________________________________ 31
5.3.2. RUNNING QUALITY CONTROL MATERIALS ___________________________________________ 33
5.4. RUNNING ANALYSES ___________________________________________________________ 34
5.4.1. RUNNING ANALYSES WITH PREPARATION LINE ACTIVATED _________________________________ 39
5.5. RETRIEVING RESULTS ___________________________________________________________ 42
5.5.1. RETRIEVING CALIBRATION RESULTS _______________________________________________ 42
5.5.2. RETRIEVING QUALITY CONTROL RESULTS ____________________________________________ 45
5.5.2.1. RETRIEVING QC RESULTS FROM THE MAIN PAGE _____________________________________ 45
5.5.2.1.1. TO FILTER QC RESULTS _____________________________________________________ 46
5.5.2.1.3. TO REVIEW LEVEY-JENNINGS GRAPH ____________________________________________ 47
5.5.2.1.4. TO PRINT QC RESULTS _____________________________________________________ 49
5.5.2.1.5. TO SEND QC RESULTS TO THE LIS ______________________________________________ 50
5.5.2.1.6. TO DELETE QC RESULTS ____________________________________________________ 50
5.5.3. RETRIEVING SAMPLE RESULTS ___________________________________________________ 51
5.5.3.1. TO REVIEW REACTION CURVES _________________________________________________ 52
5.5.3.2. TO FILTER RESULTS _________________________________________________________ 53
5.5.3.3. TO (RE)PRINT RESULTS _______________________________________________________ 54
5.5.3.4. TO (RE)SEND RESULTS TO THE LIS _______________________________________________ 54
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5.5.3.5. TO DELETE RESULTS _________________________________________________________ 55

5.6. SYSTEM ____________________________________________________________________ 56
5.6.1. GLOBAL __________________________________________________________________ 56
5.6.2. RUNMENU ________________________________________________________________ 58
5.6.2.1. RUNMENU SETTINGS________________________________________________________ 58
5.6.2.2. RUNMENU RFID __________________________________________________________ 59
5.6.3. PRINTER __________________________________________________________________ 60
5.6.4. LIS______________________________________________________________________ 61
5.6.4.1. LIS SETTINGS FOR SERIAL CONNECTION ____________________________________________ 61
5.6.4.1. LIS SETTINGS FOR ETHERNET CONNECTION _________________________________________ 62
5.6.5. CONFIGURATION (OF ASSAYS) ___________________________________________________ 63
5.6.5.1. CREATING NEW METHOD _____________________________________________________ 63
5.6.5.2. DELETING EXISTING METHOD __________________________________________________ 65
5.6.5.3. METHOD PARAMETERS ______________________________________________________ 67
6. INSTALLATION _______________________________________________________________ 73
6.1. SITE PREPARATION ____________________________________________________________ 73

6.2. SYSTEM PREPARATION _________________________________________________________ 73
6.2.1. UNBOX THE SYSTEM __________________________________________________________ 73
6.2.2. PREPARE THE SYSTEM FOR INSTALLATION ____________________________________________ 74
6.2.3. INSTALL PAPER ROLL __________________________________________________________ 75
6.2.4. PRECAUTION GUIDE __________________________________________________________ 76
7. MAINTENANCE ______________________________________________________________ 78
7.1. DAILY _____________________________________________________________________ 78

7.2. WEEKLY____________________________________________________________________ 78
7.3. MONTHLY __________________________________________________________________ 78
7.4. QUARTERLY _________________________________________________________________ 78
7.5. ANNUALLY __________________________________________________________________ 78
7.5.1. MEASUREMENT ELEMENTS CHECKS________________________________________________ 79
7.5.1.1. CHECKING THE NEPHELOMETRIC MEASUREMENTS ____________________________________ 79
7.5.1.2. CHECKING THE INFRARED MEASUREMENTS_________________________________________ 79
7.5.2. VERIFICATION / RECALIBRATION OF TEMPERATURES ____________________________________ 79
7.5.3. STIRRING FUNCTION CHECKS ____________________________________________________ 80
8. TROUBLESHOOTING __________________________________________________________ 81
8.1. DIAGNOSTICS CHART ___________________________________________________________ 81
9. PERFORMANCE ______________________________________________________________ 85
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9.1. PRECISION __________________________________________________________________ 85

9.2. LIMITS _____________________________________________________________________ 86
10. LIS SETUP __________________________________________________________________ 87
10.1. GENERAL __________________________________________________________________ 87

10.2. HARDWARE CONFIGURATION ____________________________________________________ 87
10.2.1. SERIAL COMMUNICATION _____________________________________________________ 88
10.2.1.1. CABLE SPECIFICATIONS______________________________________________________ 88
10.2.1.2. ECL412/105 RS232 CONNECTION ____________________________________________ 89
10.2.2. NETWORK COMMUNICATION___________________________________________________ 89
10.3. WORK MODE _______________________________________________________________ 90
10.4. PROTOCOLS ________________________________________________________________ 90
10.4.1. PHYSICAL PROTOCOL: ASTM 1381 ______________________________________________ 90
10.4.2. LOGICAL PROTOCOL : ASTM E 1394 _____________________________________________ 92
10.4.3. RESULTS _________________________________________________________________ 92
11. DISPOSAL __________________________________________________________________ 96
11.1. END OF LIFE DISPOSAL _________________________________________________________ 96
12. PACKAGING ________________________________________________________________ 97
12.1. TRANSPORT REQUIREMENTS _____________________________________________________ 97

12.2. PACKAGING LABELS ___________________________________________________________ 97
13. CONTACT __________________________________________________________________ 98
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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 Lachema ECL 105 Analyzer is a single 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 2 types of optical measurement principles: Clotting and Turbidimetric
(immunologic) on centrifuged citrated plasmas.
2.2. Intended Use

The ECL 105 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
Intrinsic factors: Fact 8µl 1/5 40µl 3 40+40+40

VIII, Fact IX, Fact XI,
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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)
Fact XII
D-Dimer
D-Dimer 15µl 2 75+60
Others
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 105 is a :
o Single channel semi-automated haemostasis instrument

o It can analyze 1 test at a time
o It is also possible to have a second position of assay preparation/incubation during the
analysis of the current one
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 Immuno-turbidimetric (turbidimetry at 800nm)
See Chapter 3 for details of operating principles.
Dimensions / Weight:
o Dimension : 216 x 205 x 75 mm

o Weight : ~1 kg
Environmental requirements:
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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 : 150 VA 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 1000 results for QC determinations
o Up to 1000 results for patients
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= Measuring channel
4= Incubation area for 5 reaction
cuvettes
5= 37°C reagent incubation area:
 One 24 mm Diameter vial

with programmable stirring
 2 reagent cups
6= Ambient reagent incubation area
for 2 reagent cups
Figure 1: ECL 105, top/Front view
1= RFID receptor
Figure 2: ECL 105 Left side view
1= Build-in Thermal Printer cover

2= USB port type B
3= USB port type A
4= RS232 serial port
5= RJ45 Ethernet port
6= ON/OFF switch and Power supply
unit connector
7=
Figure 3: ECL 105 rear view
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2.4.2. Module Description
2.4.2.1. Colour touch screen
The display is a 3.5 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.
2.4.2.2. Built-in thermal printer
The device is a 2 inches integrated thermal printer. It prints automatically and/or on demand
results and other information.
2.4.2.3. 37°C temperature controlled area
This area includes the Measuring channels, the reaction cuvettes incubation area and the 37°C
reagent incubation area. It is made of an aluminium block, heated at 37+/-0.5°C and controlled by
several temperature sensors.
2.4.2.3.1. Measuring channels
There is 1 measuring channels on the ECL 105:
 It can perform nephelometric (clotting by scattered light) measurements

 and can also perform turbidimetric (immunologic) measurements at 800nm
2.4.2.3.2. Reaction cuvettes incubation area
This area is composed of 5 positions. It can hold the reaction cuvettes.
2.4.2.3.3. 37°C reagent incubation area
This area is composed of a total of 5 reagent positions:
 1 position for a 24 mm diameter vial. This position is equipped with a stirring device
 4 positions for 3ml cups for reagent incubations
2.4.2.3.4. Reagent Stirring device
The reagent vial position is 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.
2.4.2.4. Ambient temperature reagent incubation area
This area is composed of a total of 2 reagent positions for 3 ml reagent cups incubation at room
temperature.
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2.4.2.5. Radio Frequency Identification (RFID)
The ECL 105 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.
2.4.2.6. Interface
At the back and on the side of the ECL 105 a number of connections and buttons are present.
2.4.2.6.1. ON/OFF switch
This switch is used to turn the instrument ON and OFF.
2.4.2.6.2. External Power Supply
The ECL 105 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.
2.4.2.6.3. Serial Port
The Serial port is a RS232 9 pin connector for serial communication to the LIS.
2.4.2.6.4. USB port Type A
1 USB port type A is present, on the back of the instrument. It can allow automatic saving of
the reaction curves, which can be viewed when checking details in the Results and/or
connection to scanner.
2.4.2.6.5. USB port type B
A USB port type B is present and can be used.
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2.5. Instrument identification label
Figure 4: Instrument identification labels for India (a), for rest of the world (b)
2.6. ECL 105 Accessories list

The ECL 105 analyser is delivered with the following accessories:
Item Quantities
ECL 105 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 3
Metal black adaptor ring 25 to 22 mm 1
Thermal paper roll 57mm 3
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3. Operating Principles
3
The ECL 105 uses optical detection for 2 types of analyses:
 Determination of clotting time

 Immuno-Turbidimetric measurement
3.1. Determination of Clotting times

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. Immuno-turbidimetric measurements

The turbidimetric measurements are done using a LED emitting at 800nm. A photo detector
positioned on the other side of the cuvette measures the intensity of the light after crossing the
reaction mixture. The intensity of the light will vary as the reaction evolves and the Optical Density
(OD) is calculated. The Delta OD (dOD) is calculated from the beginning of the reaction to the end.
Using a calibration curve with known concentrations, the patient sample is calculated in the
calibrators’ unit.
This measurement method is intended for immunologic reactions using latex based reagents that
are compatible with 800nm wavelength, typically D-Dimer. During these reactions, an immune
complex antigen-antibody will form and create optical turbidity which will decrease the light
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 105, 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 5.6.2.2 (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 105.
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 phases 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
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
DRVVT
Screen
Lupus Lupus confirm 75 µL
DRVVT
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
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
Intrinsic Factor Owren's Veronal Buffer Calibrator: ref. EHL00012 Erba Standard Plasma
APTT based 4 point calibration:
Pure, 1/2 , 1/4 , 1/8
DDimer Ddimer Diluent Calibrator: ref. EHL00018 or EHL00044 DDimer calibrator
6 point calibration:
Pure, 1/2 , 1/4 , 1/8; 1/16 , 1/32
Prot S Prot S Saline solution Calibrator: ref. EHL00012 Erba Standard Plasma
4 point calibration:
Pure, 1/2 , 1/4 , 1/8
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Parameter Diluent to be used Dilutions of calibrator

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 : 80 µL :
Factor 80µl of buffer +20µl of sample 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
DDimer DDimer Buffer 75 µL
DDimer Latex 60 µL
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
Screen
Lupus Lupus confirm 75 µL
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 verified and calibrated automatic pipettes that can inject:
 Volumes from 10 to 30µl 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 105 logo that will disappear once any function is
selected.
From this screen all parts of the software are directly accessible thanks to a side bar that consists
of all the menu buttons.
5.1.2. Side Bar
The Side Bar is always visible on the right of the screen, regardless of the location in the software.
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5.1.3. Analysis button
The Analysis button opens the window where testing can be performed.
DEFAULT / SELECTED /
BUTTON ACTIVE INACTIVE DESCRIPTION / USE FORMAT
STATUS STATUS
Analysis
Window
Where analyses can be carried out. Button
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 sample results. This includes results (in all units applicable
for the method), reaction curves (if USB key was/is connected to instrument) and alarms.
STATUS STATUS
Results window calls for results screen including Button

reaction curves
5.1.5. Quality Control button
The Quality Control button opens the Quality control windows which allows Control Lots to be
added to the system and monitored via QC tables with integrated error flagging and Levey-
Jennings charts with monitoring statistics.
STATUS STATUS
Quality control Calls for all commands and windows Button

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.
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. System button
The System button opens the system parameters and the Configuration. it includes Global, running
menu, Printer, LIS and Configuration. 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.
All these windows will be detailed in their specific sections.
STATUS STATUS
calls for the system parameters

System and the Configuration of the button
methods
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5.1.8. 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,
date & time
Figure 5: Status bar, instrument warming up, temperature not reached: Not Ready
Figure 6: Status bar, temperature reached within range: Ready
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5.2. Running Calibration

Running Calibration on the ECL 105 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 steps of the method.
5. Fill the reagent name(s), lot numbers and expiries 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 by clicking on.
8. Then go to Analysis
9. Run the calibrator material as samples (See 5.4 for details)
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10. Write down analyzer’s responses
11. Go back to the calibration and go to the second page, by clicking on to reach
page 2 of 3
12. Enter the Target and analyser responses for the different units
13. Then Save
14. Page 3 of 3 contains the INR or ratio calibration

information, go to it and save as needed
depending on the assay.
Note: for some calibrations it is possible to view the Calibration curve, see 5.5.1 for more details
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5.3. Running Quality Controls

To fully take advantage of the Quality Control program of the ECL 105, the Quality Control
materials should be defined and identified in the software.
The software lets you define 12 different quality control materials which can be assigned to any or
all of the existing programmed methods.
If your Quality Control materials are already defined and the lots and values are already entered,
go to 5.3.2 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
2. Click on the Set QC button
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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 in the Set Bank name field with the keyboard
(up to 14 characters)
e. Press the Enter key to validate and save the name
4. If the name of the QC is already defined, select it from the drop down list
5. Enter the Lot number in the Lot Number field
6. Enter the Expiry date:
a. By clicking on the field the calendar opens
b. By default it opens on today’s date

c. The date can be changed by using the different arrows and clicking on the Day:
i. Change the year directly by clicking in the
year field, and typing the full year in the
ADD_YEAR field with the keyboard (ie 2017)
and pressing to validate it
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 or stylus
iv. Click on the button 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 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 Select the name of the desired QC material by clicking on the name list
o Then click on the OK button (check 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 105, 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). If more than 4 methods are present in the group
an arrow down will be present to display the next 4 methods.
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3. Select the desired assay,

4. The information screen will popup (as shown below),
5. Close it with the 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.
6. 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.
7. Click on the ADD ID field, the following Dialogue box opens
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8. Select SAMPLE to run a sample (to run control, refer to Running Quality Control analysis)
9. Enter 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
10. Press to validate the ID
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11. Then the system prompts to ADD TUBE with blinking Green/Grey border. Place a clean
empty Erba reaction Cuvette in the prompted channel
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.
12. Pipette the sample or reagent as instructed, following the correct volumes as stated in the
section 2.2 and reminded in the information window from
Note: When the user is prompted to add any element during the testing steps the button frame
blinks between Grey to the current colour. For the addition of the starter step the system will blink
from White to Orange with concomitant instrument beep to create a stronger contrast and signal.
13. The injection of the liquid will be automatically detected and the system will move to the
next step, for example Incubation as shown below
14. The incubation is counted down in seconds. The button frame is now Orange, the
countdown lettering is White.
15. When the countdown reaches 5 seconds before the end of incubation: The frame blinks
from orange to grey, the countdown becomes in Orange letters giving the user a visual
information to get ready to inject
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16. When the countdown reaches 0 seconds, the systems instructs to ADD NEEDED PRODUCT
(named)
17. When the incubation time is reached (0) then:

a. the system beeps for 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.
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
18. 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.
19. The system will read until either it finds the end of the clotting process or the end of the
measurement process depending on the assay algorithm.
20. If no clot is detected the measurement will be pursued until the end of the maximum
measurements as defined in the method configuration.
21. Once the end of the clotting reaction is detected, the system stops counting up seconds
and will quickly calculate and report the clotting time, the display switches to Sample ID,
RESULT, XX.X sec
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22. The result is automatically printed if a paper roll is inserted and the result displayed in the
table above the channels.
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 back or next
buttons.
5.4.1. Running analyses with Preparation line activated
To activate the timed Preparation “line”, go to System, Running Mode, and activate preparation
line (refer to 5.6.2 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 test as usual, then during the process of the first one, another reaction of the same
parameter can be prepared:
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1. Click on the ADD ID top button to open the dialogue box sample/control choice
2. Select the type and either select the Control name or type the sample ID as during normal
operations on the measuring channel
3. The instrument will instruct and guide the user to the required steps,
4. to inform the system that the step has been completed, click on the status line button and
select the arrow to the right
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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 2 down
arrows, as shown below.
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
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4. To view the calibration curve:

5. Click on CHART button, page 1 of 2 opens
a. The graph displays the response on the X axis and the Concentration on the Y axis
b. The calibration points/responses are represented by a red square outlined
c. The calibration curve is a line going through the points according to the method
selected calibration curve fitting.
d. The graph can be printed by clicking on the Print button
e. An active arrow to the right allows to go to page 2

6. If you wish to see the calibration data, click on the next page button
a. In the table showing the calibration data:

b. The 6 columns represent the 6 possible calibration points
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c. The first line corresponds to the theoretical calibrators values with its unit
d. The 2nd line corresponds to the Response of the analyser (Clotting in sec, signal in
Delta OD, etc., depending on the assay)
e. The last line corresponds to the recalculated value of the response using the
calibration equation used
f. The data table can be printed by clicking on the PRINT button
7. Click on the Door button to close the window.
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
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5.5.2. Retrieving Quality Control results
5.5.2.1. Retrieving QC results from the main page

Results of Quality Controls can be seen during the run in the table displayed above the measuring
channels (and preparation line when applicable) status. Refer to Running analyses (5.4) for more
details.
But to review the Control results in the Quality Control program of the ECL 105:
1. Click on QC button
By default the window opens with the results of the last Quality Control determination
The page contains 3 areas:
 Area 1
o The record area: it displays the position of the results the available QC data, displayed
as X/Y (1/7 on the example above)
o A FILTER button is displayed in blue colour, unless a filter is active then it is orange
 Area 2 : The result information contains:

o The Meas Name, which corresponds to the assay
o The ID, corresponds to the QC material name the way it was defined in the system
o The date and time of the result calculation
o The raw result from the instrument
o The result corresponds to the main unit
o Min and max values correspond to the values entered for this QC material lot number
(as entered from the QC definition window)
o Alarms:
o If alarms are present a red button will be present on the upper right corner of
the results area,
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o clicking on the ALARM button will display the actual message(s) from the
instrument
o If the result was printed a check box will be displayed for printed
o Same for the Sent check box in case it was sent to the LIS.
 Area 3 : Functions and navigation:

o The 2 arrows allow the user to go to the next and/or previous QC results
o In the middle of this section a FUNCTIONS button can be clicked to access the
functions. The list of functions are:
o Print
o Send
o Delete
o Levey-Jennings
5.5.2.1.1. To filter QC results

If you wish to filter the results by some criteria:
1. Click on the FILTER button, it opens the Filter dialogue box below
2. Then select the QC name, and/or the assay name, and/or the unit to restrict the list of
results displayed
3. Click on the Check button to apply the filtering (Or click on the X button to
cancel the request)
When the results are displayed using a filter, the FILTER button is displayed in Orange
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5.5.2.1.3. To review Levey-Jennings graph

1. Click on the orange FILTER button
2. Then select the QC name, and/or the assay name, and/or the unit to restrict the list of
results displayed
cancel the request)
Once filtered:
4. Press on the FUNCTIONS button
5. The following dialogue box opens
6. Press the LEVEY JENNINGS button, The following window opens
 The window can be closed by pressing the button

 All QC determinations for that given QC material/Lot number/Assay are plotted on the
graph.
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Notes:
 The QC AVG represents the defined QC target, and represented by a Black line
 The QC MIN and QC MAX respectively represent the -3 and +3SD limits and are
represented by Red lines
 The 1SD limit are represented by Green dotted lines
 The 2SD limits are represented by an Orange dotted lines
 Results that are within the 3SD limits are represented as dots ●
 Results exceeding + or – 3SD are represented as triangles ∆
 By default all the points are included and are linked one to the next point by a Blue line
 Included results are represented by a Black shape ● or ∆
 Excluded points are represented by a Red shape ● or ∆
7. If more points than the available space on the screen are available, use the left and right
arrows to move through the data points

8. If needed click on a graphical point to open the detailed information about the QC
determination:
o The QC name
o The lot number
o The date / time of the result
o The result and its unit
o The defined acceptable range of this QC for that unit
To reject a point from the Levey Jennings:
 Click on the button
 The button is then changed to the button and the point becomes Red
keeping its original shape.
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 The window can be closed by pressing the button
5.5.2.1.4. To print QC results

1. Press on the FUNCTIONS button, the following dialogue box opens
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2. Click on the print button

3. Then select one of the 3 options by clicking on the relevant button on the right:
o Current
o Not PNR/SND (for not printed or not sent)
o All
As soon as the 2nd element is selected the command is executed.
5.5.2.1.5. To send QC results to the LIS

2. Click on the send button

o Current
o All
5.5.2.1.6. To delete QC results

It is possible to selectively remove some QC points from the memory to preserve room for
important QC data.
2. Click on the delete button

o Current
o All
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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 , the following window opens
By default the window opens with the results of the last test performed
The page contains 3 areas:
 Area 1
o The record area: it displays the position of the results the available QC data, displayed
as X/Y (1/33 on the example above)
o A FILTER button is displayed
 Area 2 : The result information contains:

o The Meas Name, which corresponds to the assay
o The ID, corresponds to the ID entered when running the test
o The date and time of the result calculation
o The raw result from the instrument
o The result 1, 2 and 3 as applicable
o Alarms:
o If alarms are present a red button will be present on the upper right corner of
the results area, indicating the number of errors
o clicking on the ALARM button will display the actual message(s) from the
instrument, refer to the troubleshooting section (8) for more information
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o Click on the check button to close

o If the result was printed a check box will be displayed for printed
o Same for the Sent check box in case it was sent to the LIS.
 Area 3 : Functions and navigation:

o The 2 arrows allow the user to go to the next and/or previous results
o In the middle of this section a FUNCTIONS button can be clicked to access the
functions. The list of functions are:
o Print
o Send
o Delete
o Result (reaction) curve
5.5.3.1. To review reaction curves

If a USB pendrive was inserted during the testing, the reaction curve is recorded onto the pendrive.
From the result window, with the pendrive inserted:
1. Click on the FUNCTIONS button
2. Click on the Result Curve button
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 The reaction curve window opens
 The curve can be printed by clicking on the Print button
3. Close the window by pressing the button
5.5.3.2. To filter results

If you wish to filter the results by some criteria:
1. Click on the FILTER button, it opens the Filter dialogue box below
 Results can the filtered by any combination of the 3 selections below:

o ID
o Assay
o Date
2. Then select the sample ID, and/or the assay name, and/or the date to restrict the list of
results displayed
cancel the request)
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5.5.3.3. To (re)print results

From the result window, once on the desired sample results
1. Press on the FUNCTIONS button, the following dialogue box opens
Figure 7: Functions options: (a) without USB data key present, (b) with USB data key inserted
2. Click on the print button

o Current
o All
5.5.3.4. To (re)send results to the LIS

From the result window, once on the desired sample results
5. Click on the send button

o Current
o All
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5.5.3.5. To delete results

The memory of the instrument limits the total number of determinations which can be stored.
Therefore a regular removal of results is done automatically.
To provide space and keep data longer, it is possible to manually remove some results
2. Click on the delete button

o Current
o All
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5.6. System
The system is where all instrument settings and method configuration 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
 Configuration
5.6.1. Global
Global consists of:
 Date and Time information

o Enter Date by clicking on the Date Field, this will open the calendar dialogue box
 Enter the year first,
 then select the month with the arrows,
 then click on the day
o Enter the time by using the Up and Down arrows on the Hour and Minutes,
 by default it is on 24H (button displayed as 24H highlighted orange),
 click on the 24H to toggle to the 12H
 the button becomes blue and labelled 12H
 to enter the time, click on the field, then enter
the hours first from the keyboard (enter 16 for
4pm)
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 then enter the minutes

o The information displayed in this screen is immediately saved to the system
 Bright(ness) Consists of a scrolling cursor indicating the level of backlight of the display
 Mute
o The Mute button has 2 states:
 The orange speaker means that the sound is active
 The Blue crossed speaker means that the system is on Mute

 Software language selector
o Click on the list to select the desired version
 Service button
o This button gives access to the Service software, protected by passwords and
reserved to technical service.
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5.6.2. RunMenu
The RunMenu is divided in 2 sections:
o MEASURE: settings linked to running the analyser

o RFID to manage the consumables controlled by RFID
5.6.2.1. RunMenu settings

Click on the MEASURE button to access the following settings:
 Reagent incubation mixing.

o The stirring of the reagents can be set ON or OFF.
 Identification:
o Sample ID can be user defined or automatically autoincremented by the
instrument
o Select ON to define manually the sample ID for each channel.
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 Workflow:
o A Preparation “line” can be activated for experienced users, to be able to prepare
another test 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 5.4.1
for more details on how to operate with the preparation line)
5.6.2.2. RunMenu RFID

When new supply needs to be entered into the system (reaction cuvettes),
o Place the kit orienting the RFID tag next to the RFID logo on the left side of the
instrument
o Click on the System, RunMode then 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 box tag to the device
in the white field below the RFID / DEVICE information
o Then click on the tag to device Logo to save it
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If more than 1 page of information is present, use the arrow left and right to review the
other pages.
o If the laboratory is equipped with more than one compatible device and too much
supply has been transferred by mistake to one device, supply can be placed back to
the Tag by pressing the (Device to Tag) logo
Upon saving in one direction or the other, the instrument writes to the RFID tag on the box or kit.
5.6.3. 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
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5.6.4. LIS
The ECL 105 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 2 possible selections between SERIAL and ETHERNET
5.6.4.1. LIS settings for serial connection
Select the SERIAL box then click on the SETTINGS button
A sub selection between RS232 or VCP is requested (by default RS232 is selected):
Parameters include the information needed to be configured to achieve the communication with
the Host computer. This includes: Baud, Bits, Parity, Stop bits
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5.6.4.1. LIS settings for Ethernet connection
Select the ETHERNET box then click on the SETTINGS button
The system can be configured with Fixed IP (STATIC) or DHCP
Fields to be entered are IP, Mask, Gateway, Server IP, Port number.
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5.6.5. Configuration (of Assays)

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

New methods can be created on the ECL 105. To create a new method:
1. Click on the SYSTEM button

2. Then click on the CONFIG button from the left button raw
3. Then Click on the NEW METHOD button, the following window opens:
4. Select the group name where you wish to place the new method, the following
window opens with keyboard to enter the name of the new method
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5. Enter the method as desired (Maximum 14 characters, different from already

existing names) and press enter to validate the new name
The window goes back to the previous screen and a message new method saved
appears briefly on the screen
6. To configure the method,

i. Click on METHOD PARAMETERS. (from System, Config)
ii. Select the group name where it is organized,
iii. Click on the assay name, see 5.6.5.3 for instructions.
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5.6.5.2. Deleting existing method

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

3. Click on the DELETE METHOD button
4. Click on the name group where the method to be deleting is organized.
5. Then click on the method name that needs to be deleted
a) Erba methods are protected and cannot be deleted, if one of these methods is
selected, the following message will appear briefly and disappear automatically
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b) For a user defined method, a confirmation message will be displayed, (as shown
below):
c) Answering X will cancel the deletion request
d) Answering will delete the method, the following message will appear
briefly and disappear automatically
WARNING: Once a method is removed, all results, calibration and controls linked to this
method will be discarded and lost.
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5.6.5.3. Method parameters

The method parameters are what defines a method: Type of Measurement,
replicate, steps, calibration type, units, normal values, etc.
Note: All the Erba methods are already defined and protected in the instrument. Certain elements
of the methods can be edited though:
 Duplicates
 Normal values
 Units
To review or modify parameters:

3. Then click on the METHOD PARAMETERS button
4. Click on the name group where the method to be reviewed or modified is

organized.
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5. Then click on the method name that needs to be reviewed, programmed

or modified, the following window opens
Note: the method parameters is composed of 5 pages:

- Page 1/5 measurement type and units,
- page 2/5 workflow (method steps),
- page 3/5 material
- page 4/5 for measurement timing, limit values and calibration type.
6. Fill in the information present in page 1/5 of the method parameters:

i. Type of measurement:
o Clotting
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 fine (for Clotting tests)
o Best fit APTT (for Clotting tests)
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o Fibrinogen (for Clotting tests)

o dOD (Delta Absorbance for turbidimetric and Chromogenic assays)
iii. 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
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
iv. For each unit select the reporting format (decimal format 9, 9.9; 9.99)
7. Click on the SAVE button to save the data from page (1/5)
8. Click on the NEXT button to get to the next page (2/5) of the
method parameters
9. Fill in the information present in page 2/5 of the method parameters:

i. The steps definition:
The steps should follow one another. For each step define the action from the drop down list,
tick the box to request a mixing instruction for the user and the incubation time in sec before
the next step.
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o Sample
o Reagent1
o Reagent 2
o Reagent 3
o Reagent 4
o Diluent
o Buffer
o Latex
10. Click on the button to save the data from page (2/5)
11. Click on the button to get to the next page (3/5) of the method
parameters
12. Fill in the material information in page 3/5 of the method parameters:
Note: The reagent names are taken from the database and cannot be edited. Only Erba methods
have information available for names in that window. The name of the reagents for user defined
methods can be edited in the calibration window. (see 5.2 for more details)
i. Enter the volumes for each step; so they can be reported to the information screen in the
Analysis mode
parameters
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15. Fill in the necessary information:

ii. the measurement timing definition
o Minimum time or First read time
o Maximum or second read time depending on the type of measurement
o Lag time (occulted time for clotting tests)
iii. Enter the 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 in page 1/5
parameters
18. Fill in the necessary information:
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iv. Enter the dilution factor (it will be reported in the information window of the Analysis
mode)
v. Enter the Alert level (expressed either in mL or Number of tests depending on the assay)
vi. For Erba protected method, PT methods in particular which are programmed for 3 units:
 %
 INR
 Sec
It is possible to disable the main unit, in case you do not intend to report in this unit. To do
so, tick the Disable main unit check box
vii. Then select the type of calibration curve
o Lin-Lin (regression linear of all points on the 2 linear axes)
o Lin-Lin p-p (Point to Point on the 2 linear axes)
o Log-Log (Linear regression of all points on the 2 Log axes)
o Log-Log p-p (Point to Point on the 2 Log axes)
20. A confirmation message will be displayed briefly and disappear
automatically.
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6. Installation
6
6.1. Site Preparation

Ensure the bench space chosen for the ECL 105
 Is a level surface
 Is away from direct sunlight
 Is a at least 220 mm (W) x 210 mm (D)
 Has at least 100 mm back clearance to ensure ventilation and connection of USB key
 Is sturdy enough to sustain 2 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
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3 4
5 6
 Open the outer box 1

 Remove the accessories to uncover the inner box 2
 check the accessories against the packing list and place them securely aside
 Remove the inner box with the instrument 3 4
 Open the inner box as shown on pictures 5 6
 Remove the instrument from the outer box (Hold the instrument securely)
 Remove the protecting bag
 Verify that the system is free from any visible damage
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 2.4.2)
 Then plug the power cord to the wall socket
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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
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6.2.4. Precaution guide
Hardware requirements:
Improper grounding to instrument bypasses the important safety features and may
result in biased results or in permanent damage to the analyzer that may void the warranty. It is
necessary to ensure proper grounding. The main electrical network should comply NFC15100
standard.
Warning: Installing the ECL 105 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 105 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
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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.
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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 monthly basis.
7.5. Annually
There is nothing special to be done on an annually basis.
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But depending on the accreditation of the laboratory, if requalification is required the follow
elements should be checked:
1. Measurement elements
2. Temperature controlled elements
3. Stirring function
The following sections 7.5.1 to 7.5.3 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 measurement checks should be performed.
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 measuring channel is equipped with a Red LED to obtain the nephelometric measurements.
Using the service menu the engineer will read the AD value 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 Channel is also equipped with an Infrared LED to read at 800nm.
Using the service menu the engineer will read the AD value using an IR filtered glass reference
cuvettes.
Required AD range in both channels: 1085 – 1715.
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 channel and incubation position as marked in the picture
below. These points being the most distant from the heating source.
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th
Figure 8: temperature checking points: Measuring channel et 5 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.
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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 5.6.1 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
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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,
haemolysis, 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,
haemolysis, 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
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Observation Meaning
Check the Following

 Retest sample
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
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Observation Meaning
Check the Following

the number of requested tests.
 Limit the batch to the number of
possible tests
 Then add supply through RFID (or add
new supply But be careful, 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
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9.9 Performance
9.1. Precision
The analyser ECL 105 performance were evaluated with the Erba reagents. Results are as follows.
Parameter Reagent Unit C.V. * C.V. limits ** Other

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
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
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
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.
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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
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
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
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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.
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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
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10.2.1.2. ECL412/105 RS232 connection
The serial cable must be plugged to the standard DB9 connectors of the PC, referenced in the
Windows system as « COM Ports ».
If it is not the case, you must plug in the PC either an electronic card (RS 232 serial card), or use an
USB-Serial adapter (if your 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.
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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 is resumed in the next page.
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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
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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
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Sending several results :
When the transmission of several results of an analysis is needed (for example , PT with seconds,
percent and INR):
For a PT Test transmission will be:
3 results lines are sent with the same code (PT)
H|\^&|||||||ECL_412
P|1||1
O|1|1||^^^PT|||||
R|1|^^^PT|34.884365|%||||||||20150625162726||
R|2|^^^PT|0.000000|INR||||||||20150625162726||
R|3|^^^PT|9.200000|Sec||||||||20150625162726||
L|1
Date/Time of execution :
The 13th Field contains date and time when test has been completed on the ECL412/105 This date
format is YYYYMMDDHHMMSS
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Fields Table:
Field 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
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6-10 Unused fields
Ligne R
1 R
2 Sequence number
3 Analysis parameters :
component # 1,2,3 : unused
component # 4 : Analysis parameters
4 Result
5 Unit
6-12 Unused fields
13 Date/time completion Format YYYYMMDDHHMMSS
14-15 Unused fields
L Line
1 L
2 Sequence number
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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.
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12 Packaging
12.
12.1. Transport requirements
Transport Environment limit ranges
 Temperature: 5-40°C
 Humidity: 5- 90% (non-condensing)
 Shock < 35G
12.2. Packaging labels
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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)
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ECL 105

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

health, which could otherwise be caused by inappropriate

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 _______________________________________________________ 19

3.1. DETERMINATION OF CLOTTING TIMES _______________________________________________ 19

3.2. IMMUNO-TURBIDIMETRIC MEASUREMENTS ___________________________________________ 19

4. ANALYSES PREPARATIONS _____________________________________________________ 20

4.1. STARTING UP THE INSTRUMENT____________________________________________________ 20

5. USER INTERFACE _____________________________________________________________ 24

5.1. SOFTWARE GENERAL INTRODUCTION ________________________________________________ 24

5.5.3.5. TO DELETE RESULTS _________________________________________________________ 55

6.1. SITE PREPARATION ____________________________________________________________ 73

7.1. DAILY _____________________________________________________________________ 78

8.1. DIAGNOSTICS CHART ___________________________________________________________ 81

9.1. PRECISION __________________________________________________________________ 85

10. LIS SETUP __________________________________________________________________ 87

10.1. GENERAL __________________________________________________________________ 87

11. DISPOSAL __________________________________________________________________ 96

11.1. END OF LIFE DISPOSAL _________________________________________________________ 96

12. PACKAGING ________________________________________________________________ 97

12.1. TRANSPORT REQUIREMENTS _____________________________________________________ 97

13. CONTACT __________________________________________________________________ 98

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

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

Assay Volume Predilution Volume of Number Volume of reagents

D-Dimer 15µl 2 75+60

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 Single channel semi-automated haemostasis instrument

o Clotting (scattered light at 640nm)

See Chapter 3 for details of operating principles.

o Dimension : 216 x 205 x 75 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

 One 24 mm Diameter vial