Diesse VES-MATIC EASY User manual

INSTRUCTIONS MANUAL
Software Release N° 2.07
Rev. 2.1 issued on November 2017
Automatic instrument for the determination
of the Erythrocyte Sedimentation Rate (ESR)
(Patented)
For In Vitro Diagnostic use only

Instructions Manual
2/54 Rev.2.1 of 11/2017
MANUFACTURER
DIESSE DIAGNOSTICA SENESE S.p.A.
Via delle Rose 10, 53035 Monteriggioni (SI), Italy
Tel. [phone] - Fax. [phone]
www.diesse.it
For Technical Assistance please contact your distributor:
No page in this manual may be reproduced in any form or byany means, neither electronic nor mechanical,
for any use whatsoever without prior written permission from DIESSE Diagnostica Senese S.p.A.

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Standard applied in this document:
- 98/79/EEC “directive relevant to the In Vitro Medical-Diagnostic Devices (IVD)”
- EN 61010-1 (CEI 66-5) “Safety requirements for electrical equipment for measurement,
control laboratory use –Part1: General requirements”.
- EN 61010-2-081 Safety requirements for electrical equipment for measurement, control and
laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes.
- EN 61010-2-101 “Safety requirements for electrical equipment for measurement, control
and laboratory use –Part 2-101: Particular requirements for In Vitro Diagnostic (IVD)
medical equipment”.
- EN 61326-1 “Electrical Equipment for Measurement, Control, and Laboratory Use –
Electromagnetic compatibility requirements-Part 1: General requirements”
- EN 61326-2-6 “Electrical Equipment for Measurement, Control, and Laboratory Use –
Electromagnetic compatibility requirements-Part 2-6: In Vitro Diagnostic (IVD) medical
equipment”
- 2014/35/EU “Low Voltage Directive”
- 2014/30/EU “Electromagnetic Compatibility Directive”
- 2011/65/EU “Restriction of Hazardous Substances in Electrical and Electronic Equipment
Directive –RoHS2”
LIST OF REVISIONS
MANUAL
REVISIONS
VERSION SW
VES-MATIC
EASY
DESCRIPTION OF MODIFICATION
0.00
of
12/06
2.00
of
12/06
Initial version
1.00
of
09/14
2.01
of
05/07
Removed the address of the DIESSE distributor in USA
Changed DIESSE President
Updated CE conformity certificate in attachment A
Added CE mark and Manufacturer other symbols
2.0
of
04/15
2.06
of
03/15
Update chapter 1 and complete restyling.
2.1
of
11/17
2.07
of
01/17
Update chapter 5.3
MODELS
This manual applies to the following VES-MATIC EASY models:
DIESSE Code
Description
10376
VES-MATIC EASY

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SYMBOLS
Legend of graphic symbols used on the instrument.
Instrument satisfying requirements of European directive on in vitro diagnostic
medical devices (98/79/EC).
In Vitro Diagnostic medical device.
Date of manufacturing of the unit.
Serial number of the unit.
Manufacturer.
Legend of Electrical and Safety symbols used on the instrument.
Protective conductor terminal.
Obligation of separate waste collection according to 2012/19/EU Directive.
Warning, read the Manual and pay attention to the safety symbols.
Warning, risk of electric shock.
Legend of symbols used in this document.
ATTENTION, potential hazard of personal injuries, all conditions indicated in the
text have to be read and understood before proceeding.
CAUTION, potential danger of damage to the machine, all conditions indicated in
the text have to be read and understood before proceeding.
NOTE, important information
BIOHAZARD, danger of contamination with possibly infected materials.
Instrument satisfying CSA standards for the Canadian and U.S.A. market.

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GENERAL WARNINGS
Before installation and use of the instrument, for ensuring correct and safe use, it is recommended
carefully reading the warnings and instructions contained in this instruction manual.
It is important for this instruction manual always to be stored together with the instrument for future
consultation.
In the case of selling or transferring the instrument, make sure that the manual always accompanies
the VES-MATIC EASY to allow the new owner to be informed about its functioning and relative
warnings.
The instrument should be used only by qualified and competent personnel.

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CONTENTS
CHAPTER 1............................................................................................................................................................... 8
1.0 INTENDED USE OF THE INSTRUMENT ........................................................................................................8
1.1 PRESENTATION OF THE INSTRUMENT .......................................................................................................8
1.2 GENERAL DESCRIPTION OF THE INSTRUMENT ......................................................................................10
1.3 MATERIAL SUPPLIED WITH THE INSTRUMENT ........................................................................................11
1.4 LIST OF MATERIAL REQUIRED BUT NOT PROVIDED...............................................................................11
1.5 TECHNICAL SPECIFICATIONS.....................................................................................................................12
1.6 BLOCK DIAGRAM ..........................................................................................................................................13
1.7 TECHNICAL DESCRIPTION OF THE INSTRUMENT...................................................................................13
1.8 INFORMATION REGARDING DISPOSAL.....................................................................................................14
CHAPTER 2............................................................................................................................................................. 15
2.1 STORAGE AND TRANSPORT.......................................................................................................................15
2.2 PREPARATION AND CHECKS PRIOR TO INSTALLATION ........................................................................15
2.3 UNPACKING THE INSTRUMENT..................................................................................................................16
2.4 POSITIONING.................................................................................................................................................16
2.5 INSTALLATION...............................................................................................................................................17
2.6 RESTRICTIONS AND WARNINGS................................................................................................................18
2.7 SHUTTING DOWN AND SHIPPING ..............................................................................................................19
CHAPTER 3............................................................................................................................................................. 20
3.1 TURNING ON THE INSTRUMENT.................................................................................................................20
3.2 KEYBOARD ....................................................................................................................................................21
3.3 MAIN MENU....................................................................................................................................................21
3.4 DESCRIPTION OF THE TESTS.....................................................................................................................22
3.4.1 ESR F1 (Erythrocyte Sedimentation Rate 1h) ANALYSIS.................................................................22
3.4.2 ESR F2 (Erythrocyte Sedimentation Rate 2h) ANALYSIS.................................................................22
3.4.3 ESR F1 RANDOM (Erythrocyte Sedimentation Rate 1h) ANALYSIS................................................23
3.4.4 ESR F2 RANDOM (Erythrocyte Sedimentation Rate 2h) ANALYSIS................................................24
3.5 SET-UP MENU –SETTINGS .........................................................................................................................25
3.5.1 DISPLAY AND PRINTER SET-UP.....................................................................................................25
3.5.2 BARCODE READER SET-UP............................................................................................................26
3.5.3 PRINTING MODE SET-UP.................................................................................................................26
3.5.4 UPDATING THE DATE AND TIME ....................................................................................................27
3.6 PRINTING OF THE STORED RESULTS.......................................................................................................27
3.7 QUALITY CONTROL ......................................................................................................................................28
CHAPTER 4............................................................................................................................................................. 31
4.1 TURNING ON FOR THE FIRST TIME ...........................................................................................................31
4.2 PREPARING THE SAMPLE...........................................................................................................................31
4.3 SEQUENCE FOR PREPARING AN EXAM ESR1-ESR2 WITHOUT ID NR. AND VIEWING OF THE
RESULTS ................................................................................................................................................................32
4.4 SEQUENCE FOR PREPARING AN EXAM ESR1-ESR2 WITH ID NR..........................................................34
4.5 SEQUENCE FOR PREPARING AN EXAM ESR1-ESR2 RANDOM WITHOUT ID NR. AND VIEWING OF
THE RESULTS........................................................................................................................................................36
4.6 SEQUENCE FOR PREPARING AN EXAM ESR1-ESR2 RANDOM WITH ID NR ........................................38

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CHAPTER 5............................................................................................................................................................. 39
5.1 GENERAL RECOMMENDATIONS.................................................................................................................39
5.2 EXTERNAL CLEANING OF THE INSTRUMENT...........................................................................................39
5.3 REPLACING THE PAPER IN THE PRINTER ................................................................................................39
5.4 PERIODIC CHECKS.......................................................................................................................................41
CHAPTER 6............................................................................................................................................................. 42
6.1 SELF-DIAGNOSIS..........................................................................................................................................42
CHAPTER 7............................................................................................................................................................. 45
7.1 EXTERNAL BARCODE READER ..................................................................................................................45
7.2 CONNECTING TO A HOST COMPUTER......................................................................................................46
7.3 SPECIFICATIONS OF THE ASYNCHRONOUS SERIAL COMMUNICATION PROTOCOL ........................47
7.4 “NEW PROTOCOL” SPECIFICATIONS .........................................................................................................47
VES EASY SERIAL COMMANDS AND PARAMETER FORMAT ....................................................................47
BIBLIOGRAPHY ..................................................................................................................................................... 51
ATTACHMENT A: CE COMPLIANCE CERTIFICATE........................................................................................... 52
ATTACHMENT B: GUIDELINES FOR THE INSTALLATION REPORT ............................................................... 52
ATTACHMENT C: QUICK START GUIDE............................................................................................................. 53

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CHAPTER 1
1.0 INTENDED USE OF THE INSTRUMENT
Automatic instrument for the determination of erythrocyte sedimentation rate (ESR)
1.1 PRESENTATION OF THE INSTRUMENT
The VES-MATIC EASY is a bench instrument designed and programmed to determine the erythrocyte
sedimentation rate (ESR) in a maximum of 10 samples of blood (human or animal), contained in dedicated
cuvettes, simultaneously or individually in Random Access mode [continuous cycle].
Cuvettes compatible with VES-MATIC EASY:
VES-TEC - (refer to relative
Instructions for Use).
Non evacuated tubes to be
filled manually, containing
sodium citrate solution for
direct determination of the
ESR. Sample volume ≈ 1 ml.
CODE:
- 10201/A
- 10201/W
- 10214
- 10212
- 10210
VACU-TEC - (refer to relative
Instructions for Use).
Evacuated tubes for direct
blood drawing, containing
sodium citrate solution for
direct determination of the
ESR. Sample volume ≈ 1 ml.
CODE:
- 10200
- 10202
- 10200/W
- 10202/W
- 10208
- 10209
- 10207
- 10206
- 10600
- 10602
- 10238
- 10235
- 10200/S
10230
- 10232
- 10220
Fig. 1.1.1
The instrument is controlled by a microprocessor, the functioning of which will be described in more detail
in the following paragraphs.
The cuvettes containing the blood samples are placed in the instrument after being carefully mixed by
slowly, repeatedly turning upside down; the ESR test procedure is then performed automatically and the
results are comparable with those obtained with the Westergren method1-10.
Using the 18°slant of the tubeswith respect to thevertical axis, the VES-MATIC EASY allows for obtaining
results equivalent to those of the Westergren method (1st hour) in only 20 minutes, and equivalent to the
Westergren method (2nd hour) in only 40 minutes.

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The instrument is designed with the temperature
correction always activated and relates the results to a
temperature of 18°C according to Manley’s
Nomogram11.
However, it is possible to de-select the temperature
correction for individual laboratory needs.
Clinical concept of the ESR
The Erythrocyte Sedimentation Rate test (ESR) is performed measuring the distance travelled by red cells
in autologous plasma over a fixed period of time. In normal conditions, red cells tend to repel each other
by virtue of the negative membrane net charge, due to the presence of numerous sialic acid residues at
the level of membrane glycoproteins.
When the protein composition of the plasma is changed, with the production of so-called "acute phase
proteins", as a result of an inflammatory process or tissue damage, thanks to the binding of these proteins
(fibrinogen, immunoglobulins) to the surface of red blood cells, the negative charge of membrane potential
(Z) is altered and the red blood cells can pile-up, to form the so-called rouleaux, which then aggregate to
form microspheres of uniform radius,that begin tosediment when their density exceeds that of the plasma
in which they are immersed. The value of the ESR is then increased in all of those situations in which there
is an increase in acute phase proteins and in particular fibrinogen (which is thought to contribute for 70%
to the total phenomenon of sedimentation) and immunoglobulins (that will increase in case of onco-
hematological diseases and acute infections). ESR is therefore an indirect not specific measure of an
inflammatory state and is elevated in various pathological conditions such as inflammatory diseases
(infections, rheumatic diseases), relative/absolute increase of globulins (nephrotic syndrome, myeloma),
tissue necrosis(myocardialinfarction, tumors). ESR is useful for predicting the prognosis of some diseases
such as polymyalgia rheumatica, giant cell arteritis, rheumatoid arthritis and Hodgkins disease and is
useful as a marker of treatment efficacy in many diseases such as rheumatoid arthritis, vasculitis,
collagenosis, septic arthritis.
The erythrocyte sedimentation rate is usually higher in females than males and is increased in pregnancy
and it has also a tendency to increase in both sexes with increasing age.
In the classical formulation of Westergren the test is performed on blood anti-coagulated with citrate, in
the proportion of 4 parts blood to one part of anticoagulant. The diluted blood is then aspirated inside a
special graduatedpipette with inner diameter of 2.5 mm held vertically in a stand; the level of sedimentation
of the erythrocytes is recorded after one hour, measuring the distance between the lower face of the
meniscus of the plasma and the upper face of the layer of sedimented red blood cells.
However, in order to make the measurement of the ESR according to Westergren’s technique follow the
recommendations of the International Committee for Standardization in Haematology (ICSH)12.

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Normal ESR
During the first hour the ESR value is normally found between 1 and 10 mm in males and between 1 and
15 mm in females; in pathological conditions it increases to values of 100 mm and over.
Normal range for the VES-MATIC EASY:
MALES
up to 10 mm first hour
up to 20 mm second hour
FEMALES
up to 15 mm first hour
up to 30 mm second hour
General functioning of the instrument:
The blood collected in the relative cuvettes is manually mixed with the coagulant by repeatedly turning
upside down the cuvette; then the samples are left to stand for a preset period in order for the
sedimentation to take place. By means of a digital sensor (opto-electronic unit) the instrument
automatically determines the sedimentation level of the erythrocytes, obtained results are processed and
then either automatically printed or shown on the display.
The analytical results are calculated from the values set on the instruments and obtained via the
Westergren reference method.
Please note that inthe case of samples with a hematocrit value <15% the instrument will print the message
“(Sample) EMPTY”.
1.2 GENERAL DESCRIPTION OF THE INSTRUMENT

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Legend:
1) Cuvette-holder with 10 numbered positions
2) Display
3) Keyboard
4) Printout-Paper slit
5) EXTERNAL BARCODE connector
(External Barcode Reader)
6) USB connector
7) ON/OFF switch
8) DC IN socket for 9Vdc power supply
9) Paper-holder compartment
1.3 MATERIAL SUPPLIED WITH THE INSTRUMENT
The VES-MATIC EASY is supplied with the following material:
1 Operating Manual [English] [Order Code: P30600650]
1 “VES-MATIC EASY”CD [Order Code: P30650050]
1 Power Supply 9Vdc 2A Mod. ES18A09-P1J [MeanWell] [Order Code: P21440380]
1 Power Cord 3x0.75 L=2m Plug SCHUKO 90° - C13 [Order Code: P21890040]
1 Power Cord SVT L=2m Male Plug USA / Female Plug VDE ‘UL’ [Order Code: P21890370]
1 USB 1.1 A-B M/M Cable (1.5 mt) [Order Code: P21890360]
1 Thermal Roller Paper for Printer [Order Code: P12300000]
1 Packing-list
1 Final Inspection Report
1 Guarantee Certificate (for CAN/USA Market)
1.4 LIST OF MATERIAL REQUIRED BUT NOT PROVIDED
Dispensable pipettes only for VES-TEC cuvettes
Holder
Disposable gloves
Cleaning paper
Solutions for cleaning the instrument
ESR tubes (consult Fig. 1.1.1)
ESR Control 4 x 9 ml (2 x Level I + 2 x Level II) REF 10430
ESR Control 2 x 9 ml (1 x Level I + 1 x Level II) REF 10434

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1.5 TECHNICAL SPECIFICATIONS
Power supply
9Vdc@2A
Dimensions
143 x 218 x146 mm ( w x h x d )
Weigh
1.2 Kg
Ambient temperature
Operational
from +15°C to +35°C
Storage
from + 5°C to + 45°C
Relative humidity
tolerance
from 20 to 80% without condensation
Central unit
AVR ATMEGA128-16AC microprocessor
Display
LCD with Backlight, 16 characters x 1 row
Cuvette-holder
With 10 numbered recesses for the relative cuvettes
Optical unit
10 pairs of opto-electronic elements in solid state (photodiode +
phototransistor).
Printer
Alphanumeric with thermal paper 58 mm wide, 36 characters per
line, speed: 20 mm/sec.
Interfaces
USB
Class
II
Device safety
CEI EN 61010-1 (Ed.2001-11); CAN/CSA-C22.2 Nr.61010-1-04
(Ed.2004-07); UL61010-1 (Ed.2004-07).
EMC
2004/108/EEC “Electromagnetic Compatibility Directive”
Installation category
II
Safety requirements and functional performances of the instrument are not assured if you
use a different power supply from the one supplied in the package.

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1.6 BLOCK DIAGRAM
(Detailed diagrams are contained in the Assistance Manual)
Block diagram –VES-MATIC EASY
LEGEND:
1- C.P.U. board
2- Display
3- Keyboard
4- Reading sensors unit
5- Optical Reader motor unit
6- Printer interface
7- Printer
8- ON/OFF switch
9- External connections Interface
10- External connections [Optional]
1.7 TECHNICAL DESCRIPTION OF THE INSTRUMENT
CENTRAL UNIT
Controls and processes the data arriving from the sensors and manages the connected peripherals,
including the FLASH EPROM containing the programme. It also contains the EEPROM where all the
instrument parameters are stored.
OPTICAL READING UNIT
Unit consisting of 10 photodiode + phototransistor couples.
OPTICAL READER MOTOR UNIT
Takes care of lifting the optical reader unit in order to check the cuvettes present or incorrectly inserted,
with insufficient or excessive blood, and also detects the sedimentation level.
KEYBOARD
Consists of 4 keys used for the implementation of VES-MATIC EASY functions.
CUVETTE-HOLDER
Consists of ten numbered positions with 18° slant axis for inserting the cuvettes.
1
3
5
4
6
7
2
9
8
10

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ACOUSTIC SIGNAL
Serves the purpose of attracting the operator’s attention during specific phases of the work cycle.
It emits a "beep" sound after the keys are pressed on the keyboard.
PRINTER
Prints the results of the analysis at the end of each cycle.
DISPLAY
Displays all the messages of the instrument.
1.8 INFORMATION REGARDING DISPOSAL
The VES-MATIC EASY instrument is operated by mains voltage, therefore has been classified as
Electrical-Electronic Equipment according to the European Directive 2012/19/UE dated July 04 2012, and
subsequent amendments.
At the end of its life cycle, the instrument must be treated as separate collection, potentially infectious,
waste and eliminated according to law.

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CHAPTER 2
2.1 STORAGE AND TRANSPORT
The VES-MATIC EASY is a precision instrument and must be treated as such. Inappropriate
operations could damage the internal opto-electronic components and cause mechanical
damage.
In view of the overall dimensions and weight of the machine, the transport must be carried out manually
by taking all necessary precautions in order to avoid impact or excessive tipping over that could damage
the instrument.
“Complete packaging”
Package dimensions
WIDTH (box)
cm
30
HEIGHT (box)
cm
19
DEPTH (box)
cm
28
GROSS WEIGHT
g
2400
PACKAGING WEIGHT
g
400
Do not throw away the original packaging in case of further transportation of the instrument in
the future.
2.2 PREPARATION AND CHECKS PRIOR TO INSTALLATION
In order to ensure the safety of the instrument and the operator the following conditions must be met:
The power supply system (installation category II), must be “compatible” with the voltage
and current specifications indicated on the nameplate attached to the power supply; and it
is recommended checking the efficiency of the electrical system periodically.
Only use properly grounded outlet.
Before making connections with external instruments (PCs, Barcode readers), it will be
necessary to check the compatibility (refer to the relative instruction manuals) with the

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specifications indicated in chapter 7 and check that there is continuity between the grounding connection
and the external instruments.
The operator must be trained to be familiar with the procedures, restrictions and warnings
indicated in this manual, as well as those pertaining to safety in the work place.
The material for the operator’s safety (gloves, containers for disposing of used expendable
items, detergent solutions for cleaning the instrument) must always be available.
The positioning of the instrument must comply with the instructions indicated in paragraph
2.5.
2.3 UNPACKING THE INSTRUMENT
a. Open the external box
b. Open the box from the top and take out the accessories positioned at the sides of the instrument and
the side band.
c. Lift the instrument out of the box.
d. Remove the protective bag wrapped around the instrument.
e. Check that the material supplied complies with the packing-list.
In case of damage to instrument and/or accessories during transportation notify the Transport
Company.
In case of any shortages notify your distributor.
2.4 POSITIONING
It is expected that the instrument would be used in a diagnostic laboratory.

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For normal safety requirements and in view of the type of examination to be performed, the instrument
must be positioned away from heat sources, in areas that cannot be reached by liquids, in dust-free
environments, on a clean, level surface that is not subject to shocks or vibration.
It is recommended to place the instrument as far away as possible from any generators of electromagnetic
interference (e.g. refrigerators, laboratory centrifuges) as these could compromise the correct operation.
Maintain safety distances described in the figure (front panel free;
rear, left and right side 15 cm).
Positioning VES-MATIC EASY
It is strictly prohibited to place anything on top of the instrument.
Choose a position near a power point, which is free from interference and voltage surges.
Never move the instrument while it is operating. If necessary to move the instrument it is
compulsory to recheck the conditions listed in this paragraph before turning it on again.
Unplug and cover instrument when not in use for long periods.
2.5 INSTALLATION
Use only power supply provided!
a. Place the instrument on a solid surface as described in the previous paragraph.
b. Once the instructions provided in point 2.2 have been fulfilled and the power supply switch has been
put in the OFF position, connect the plug of the power supply unit supplied with the unit.
c. Connect the power cord to the power supply and to the AC outlet.

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2.6 RESTRICTIONS AND WARNINGS
IN CASE OF FIRE OR HAZARDS IN GENERAL, TURN OFF THE INSTRUMENT AND
DISCONNECT THE POWER SUPPLY CABLE.
DISCONNECT the instrument from the power supply system before performing any type of technical
operation or in the case of malfunctioning of the instrument.
It is only possible to enter the commands with a light pressure of the fingers.
Expendable materials [RESTRICTIONS]
Exclusively the DIESSE cuvettes are designed for use with the VES-MATIC EASY and
cannot be substituted with any other container.
The DIESSE cuvettes are disposable and must not be reused.
Cuvettes must be disposed of in compliance with the local regulation.
Treatment of potentially infected material.
All precautions pertaining biological risks must be adopted when using the VES-MATIC
EASY.
The waste material must be disposed of in compliance with the laboratory regulations and the local laws
Observe all operator safety regulation in line with the working environments.

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2.7 SHUTTING DOWN AND SHIPPING
Before shutting down and shipping the instrument it is recommended carrying out the
following sanitising procedure:
a. The instrument must be turned off and cleaned internally of all residues or spillage with a liquid
detergent and left to dry.
b. Use one of the ready-to-use spray cans of isopropyl alcohol available on the market.
c. Spray well on the sample-holder.
d. Leave turned off for at least one hour before beginning a new work cycle or any other type of operation
on the instrument.
Instrument may be damaged if dropped.

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CHAPTER 3
3.1 TURNING ON THE INSTRUMENT
Turning on
After having checked the installation of the instrument as indicated in chapter 2, turn the switch, located
on the back side of the instrument, to the position « ON ».
System start-up
When turned on, the unit will display in a sequence the instrument model and the software version installed
on the unit:
During this phase, the instrument automatically checks the following items of its own system:
Display
Clock
EEPROM data
Handling motor and home sensor
Reading sensors
Printer
In case of malfunctioning, the unit will “beep” and show an error message on the display. See
Chapter 6 - “Self-diagnostics” for help.
If this error message is displayed upon turning on the instrument, do not use the ‘X’ position indicated to
process the samples, as the reading sensor associated to that position may be damaged.
Use key to display a list of damaged sensors and pass to the Main Menu.
Once the initial self-test has been completed, the instrument will “beep” again and show the following
words on the display.
Now the instrument is ready to perform the functions that will be selected.
SW VERS.2.00
SENSOR X KO
SELECT FUNCTION