12 Channels

ESR Automated Analyzer

USER’S MANUAL

Manual code MAN-075 – Revision 01

Revision date: 06 03, 2008
ESR Automated analyzer - 12 Channels User Manual

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User Manual ESR Automated analyzer – 12 Channels

This user manual follows the directions prescribed by UNI EN 591:2001

(Instructions for use for in vitro diagnostic instruments for professional use)

INSTRUMENT NAME: Automated sed-rate analyzer,

12 measuring channels.

INSTRUMENT
MANUFACTURER: VITAL DIAGNOSTICS s.r.l.
Via Balzella, 41/G/4
47100 FORLI - ITALY
phone: + 39 (0543) 72 12 20
fax: + 39 (0543) 79 60 01

INSTRUMENT
DISTRIBUTOR

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ESR Automated analyzer - 12 Channels User Manual

CONTENT
1. INTENDED USE .......................................................................................................................................... 6

2. IMPROPER USE ......................................................................................................................................... 6

3. SYSTEM DESCRIPTION ........................................................................................................................... 6

3.1 ANALYZER UNIT ........................................................................................................................................ 6
3.2 POWER SUPPLY .......................................................................................................................................... 6
3.3 DISPLAY .................................................................................................................................................... 6
3.4 READING PLATE ........................................................................................................................................ 6
3.5 PRINTER (OPTIONAL).................................................................................................................................. 7
3.6 TEST TUBES .............................................................................................................................................. 7
3.6.1 Tubes Handling requirements ...................................................................................................... 7
3.6.2 Tubes storage requirements ........................................................................................................ 7
4. INSTALLATION ......................................................................................................................................... 7
4.1 POSITIONING OF THE ANALYZER ................................................................................................................. 7
4.2 SWITCH ON ................................................................................................................................................ 7
5. POTENTIAL DANGERS AND SAFETY MEASURES ............................................................................ 8
5.1 USER PRECAUTIONS ................................................................................................................................... 8
5.2 ELECTRICAL EQUIPMENT ........................................................................................................................... 8
5.3 MECHANICAL EQUIPMENT .......................................................................................................................... 8
5.4 SAMPLES ................................................................................................................................................... 8
5.5 NOTES ON SAFETY MEASURES ..................................................................................................................... 9
6 OPERATING PROCEDURE ..................................................................................................................... 9
6.1 READING PRINCIPLE................................................................................................................................... 9
6.2 SAMPLE’S COLLECTION .............................................................................................................................. 9
6.3 TUBES LABELING ....................................................................................................................................... 9
6.4 SAMPLE MIXING ....................................................................................................................................... 10
6.5 SAMPLE INSERTION .................................................................................................................................. 10
6.6 RESULTS PRE-INDICATION ........................................................................................................................ 11
6.7 SAMPLE REMOVAL ................................................................................................................................... 11
6.8 INTERNAL QUALITY CONTROL .................................................................................................................. 11
6.9 REMAINING TIME AND DISPLAY MESSAGES ................................................................................................ 11
7 MEASURING PRINCIPLE ...................................................................................................................... 12
7.1 INSTRUMENT CALIBRATION...................................................................................................................... 12
7.2 SURVEY METHOD .................................................................................................................................... 12
7.3 RESULTS CORRECTION TO 18°C ................................................................................................................ 12
8 MAINTENANCE ...................................................................................................................................... 13
8.1 CLEANING INSTRUCTIONS ........................................................................................................................ 13
9 ASSISTANCE............................................................................................................................................ 13

10 TROUBLESHOOTING GUIDE ................................................................................................................ 14

11 RESIDUAL RISKS ................................................................................................................................... 14

12 PERFORMANCE CRITERIA AND LIMITATIONS ............................................................................. 15

12.1 PERFORMANCE CRITERIA..................................................................................................................... 15
12.2 LIMITATIONS ...................................................................................................................................... 15
13 TECHNICAL SPECIFICATIONS ........................................................................................................... 16

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14 EC DECLARATION................................................................................................................................. 17

15 DISPOSAL AND RECYCLING ............................................................................................................... 18

APPENDIX ......................................................................................................................................................... 19
A THE ERYTHROCYTE SEDIMENTATION RATE .............................................................................................. 19
B DIP SWITCH CONFIGURATION .......................................................................................................... 20

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ESR Automated analyzer - 12 Channels User Manual

1. INTENDED USE

The analyzer is an automatic instrument controlled by a microprocessor and employed only for analysis
of the erythrocyte sedimentation rate.
It constantly and simultaneously scans 12 test tubes which are custom-made for ESR analysis.
The follows the sedimentation of each sample independently, memorizing levels for the whole period of
analysis.

2. IMPROPER USE
Following uses are considered improper:
1) Use of the device to obtain results different from ESR
2) Use tubes different from those specified in this manual
3) Every attempt to open tubes analyzed by the device
4) Use the device to analyze samples different form those specified
The above mentioned uses and every attempt to use the ESR analyzer with a purpose different from the
intended use, must be considered improper.

3. SYSTEM DESCRIPTION

3.1 Analyzer unit

The ESR analyzer is an automatic instrument controlled by a microprocessor and exclusively employed for
analysis of the erythrocyte sedimentation rate. Its total absence of commands, its precision and its ability to
obtain the result already corrected to a temperature of 18°C (according to Manley) in only 30 minutes, make
the ANALYZER the most innovative and versatile system for this kind of analysis. It constantly and
simultaneously scans 12 test tubes which are custom-made for ESR with this system.
The Analyzer follows the sedimentation of each sample independently, memorizing levels for the whole period
of analysis. This allows the instrument to be used for random loading of the samples and for a continuous
loading up to a capacity of 12 test tubes at a time. When the first sample is analyzed, it can be replaced by
another one, so it is possible to achieve up to 24 tests / h.

The Analyzer has been conceived to simplify ESR analysis as much as possible, avoiding sample
manipulation and operator’s infection risk. To perform the analysis, the operator must simply place the sample
test tube directly into the instrument. The result appears on the display in only 30 minutes. When the
compensation of the result is active, the ANALYZER surveys the room temperature and converts the result to
the reference temperature of 18°C. (Manley). This is necessary in order to avoid considerable variations of
values due to different room temperatures.

3.2 Power Supply

The analyzer is provided with an external power supply with low voltage output. The power supply comes
along with the analyzer.

3.3 Display

A two line LCD display with back-lighting, allows constant monitoring of the analyses and visualization of the
results. Sample or system error messages may also be displayed.

3.4 Reading Plate

Two rows of 6 reading channels each, numbered from 1 to 6 and from 7 to 12.

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3.5 Printer (optional)

Can be connected to the instrument through outlet RS232 C, it prints out ESR results, according to the loading
sequence, whenever an analysis is completed. It is external so it can be easily replaced. It can also be
replaced by other printers with serial entry.

3.6 Test Tubes

The unique test tubes that can be used with this instrument are Monosed Vacuum Tube expressly made to be
used with the ANALYZER. They contain sodium citrate at 3,8% and have a fixed vacuum to draw blood (item
PRD-PRV11B/PRD-PRV11V/PRD-PRV11C).

3.6.1 Tubes Handling requirements

The vacuum test tube needs to be inserted properly into its holder to obtain the automatic draw of blood
required for the analysis. Tubes are removed from the holder only after the draw has been terminated
completely, i.e. the required amount of blood for the analysis has been properly evacuated.

If an incorrect blood collection occurs, the Analyzer will refuse to analyze the sample, indicating “err.l” (Level
Error), because the Sedimentation Rate would be incorrect, due to an erroneous ratio with the anticoagulant
present in the tube. All vacuum test tubes need to be mixed gently immediately after blood collection, to
ensure a proper mixing of the sodium citrate with the freshly drawn blood.

Therefore, tubes are gently turned completely upside down five times, ensuring that the air-bubble floats
correctly from one end of the tube to the other. ESR tests should be carried out no later than 3-4 hours after
blood collection, if samples are kept at room temperature:

Refer to Tubes instructions to perform this operation correctly.

3.6.2 Tubes storage requirements

Store the test tubes at room temperature, always below 30°C .Never place the bench top tube container near
a heating device or a window where direct sunlight could create an unwanted heating effect.

4. INSTALLATION

4.1 Positioning of the analyzer

The ANALYZER must not be placed near centrifuges, oscillating agitators or other vibrating instruments which
might cause movement of the bench.
Please, keep in mind that the ESR is very sensitive to vibrations that could cause a false increase of results.
The bench must be flat and level.
Direct light on the instrument and sudden changes of temperature should be avoided.

4.2 Switch on

Connect power supply outlet to the instrument.

Insert the power supply plug in a socket with an earth connection.
If the instrument has an optional printer, it should be connected to the ANALYZER with the appropriate cable
and plugged in. Connect and switch-on first the printer, then the ANALYZER using the switch situated at the
rear side of the instrument.
Each time it is switched on the Analyzer carries out an electronic initialization and an instrument check test.
The following messages will appear:
__________________________________________________________________________

Sedy-12 V.1.0 (software version)

__________________________________________________________________________

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ESR Automated analyzer - 12 Channels User Manual

30' working time

results: 1h mm

or:

60' working time

results: 1h, 2h mm
__________________________________________________________________________

print curve ON…

printer OFF… printer OK…
__________________________________________________________________________

"no message if temp. ref = OFF"

or:

18°C temp. of reference

27.5°C internal temp.
__________________________________________________________________________

starting…

5. POTENTIAL DANGERS AND SAFETY MEASURES

5.1 User Precautions

Before beginning work with the analyzer, the operator, to protect himself from any danger, must know the rules
for handling potentially infectious materials and for the Electro-mechanical systems.

5.2 Electrical Equipment

As in all electrical equipment the power supply is a potential source of danger. For this reason, avoid to handle
parts directly hooked up to the supply without disconnecting them. Never carry out maintenance on the
equipment when it is under electrical tension. Until the equipment remains closed as supplied, the operator is
protected against electric shock. The parts to pay attention to are: the power supply and the printer.

The analyzer, being powered by low voltage, doesn’t present the same dangers of the equipment’s powered by
an electrical line. The analyzer has inside a voltage elevator circuit, so it can provoke strong electrical shocks,
but it is not dangerous for the personnel dedicated to the service assistance. In any case, we suggest to
disconnect the power supply when the operator intervene on the instrument’s internal parts.

5.3 Mechanical equipment

Even for the mechanical part of the analyzer, we suggest you not to open the machine before having
disconnected it from the power supply.
It presents only one handling that it is not dangerous for the operator, but it would damage if brought into
contact with the parts in movement.

5.4 Samples

All the biological fluids must be considered potentially infectious by operators.

Even if for the execution of the analysis the blood is not handled (because the operator must not remove the
tube stopper), the operator has to adopt the national and international standards of precautions to avoid the
biological danger. The same rules must be adopted by the technical-qualified assistance operator when
intervenes on this instrument.

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User Manual ESR Automated analyzer – 12 Channels

5.5 Notes on safety measures

The operator must pay a special attention to the sample collection. Must use the correct vacuum test tubes
described for this equipment in this manual, since these tubes have been studied to aspirate the right level of
blood.

Every attempt to put the blood into test tubes different to the one described, brings serious dangers of infection
due to the risk of sample coming out, and this, moreover, will damage the optical part inside the instrument
and provoke the loss of the guarantee. Refer to the tubes manual to have more detailed.
On the instrument, to assure a correct use of the instrument, may be placed the following symbols:

Attention: read use instruction For in vitro diagnostic use only

ELECTROSTATIC DISCHARGE SENSITIVE DEVICE (ESDS): The device could

be damaged by electrostatic potentials

6 OPERATING PROCEDURE

6.1 Reading Principle

Ten infrared barriers cover vertically the positions of ten test tubes with a cycle of about 60”. Every 0.2 mm all
the ten positions on the reading plate are analyzed. As soon as the reading plate (comprising 12 pairs of I.R.
TX / RX) begins to rise, the indicating system intercepts any positions occupied by samples containing the right
level of blood. At the first rising (when the instrument has ensured that the meniscus is clearly distinct) the level
of the sample collection just inserted is checked and actual analysis begins. The computer records the "zero"
time of each sample and all subsequent readings until 30 minutes have elapsed. During this phase the
instrument also recognizes if the sample is being properly kept in its original position. Functioning and
calculations employed for readings are explained in detail in Chapter 7 of this manual.

6.2 Sample’s collection

Samples must be collected following the vacuum technique, using only the right tube previously defined.
During sample collection, wait until the test tube vacuum has completed the drawing of the blood in order
to be sure of having drawn the right volume. See the tube’s instructions for a correct use.

6.3 Tubes Labeling

Identify the sample by writing on the original test tube label or by applying a bar code label.
Follow the scheme of Fig. (6) to carry out this action correctly. In the figure the test tube “A” has the correct
blood level and the original label on which to write the patient code or any other relevant data if the bar code
label is absent. The part marked “H” shows the transparent zone that must be absolutely free and clear to
allow the infrared rays to recognize the end of the blood column. The next test -tube “B” shows the correct
position for the label. Test- tubes C and D illustrate how erroneous applications of the labels obstruct the
reading of the analysis. If the Analyzer is installed in the surgery, the sample can be immediately analyzed by

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ESR Automated analyzer - 12 Channels User Manual

placing samples in a free position. Anyway the sample should be analyzed within three hours, paying attention
to external agents shown below that might alter ESR in the pre-analysis phase.

A B C D

LABEL
LABEL

YES YES NO NO

Fig. 6

6.4 Sample mixing

If it is not possible to analyze samples immediately after the collection, samples must be mixed delicately by
overturning for at least five minutes. Use a rotating laboratory agitator or a dedicated mixing device.
The recommended rpm-value for the mixer is 15-20 RPM.

6.5 Sample insertion

After mixing, the sample must be promptly transferred to the analyzer.

It is also advisable to follow numerical sequence when loading channels. Every time a sample is inserted into a
free channel an acoustic signal inform the user that the instrument recognized the tube.
After loading the tenth, wait for the results and then remove analyzed samples from their channels before
inserting new tubes.
The sample positions on the plate are numbered from 1 to 12 but numbering is intended progressively in
groups of 12, so when the tube in channel one is analyzed and removed, this position automatically becomes
number 11 and so on.

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6.6 Results Pre-indication

Approximately 12 min after tubes insertion, the following symbols will appear on the display, giving a pre-
indication of the result:

% (12 minutes) | Symbols

---------------------------------------
--- | 1 - 7
--+ | 8 - 16
-++ | 17 - 30
+++ | > 30

This is only a pre-indication and it can’t be used as final result.

6.7 Sample removal

As soon as sample has been analyzed, the result will be automatically printed out if a printer is connected.
Results will stay on the display until the tube removal. Remove tubes carefully, maintaining tubes in vertical
position, in order to avoid tubes breaking.

6.8 Internal Quality control

Good Laboratory Practices suggest to test every day at least one control (1 normal and 1 abnormal) to
check if the instrument is working correctly.
Vital Diagnostics developed a special control for ESR values: Precision Rate (ref.: PRD-ESRQC). This
control simulates the behavior of normal and abnormal human blood and can be used to test the
instrument’s performances. Controls must be tested exactly as normal patient’s samples and results
should be recorded on Quality Control Charts. Each laboratory can establish its own acceptability ranges.
Refer to Precision Rate instructions for more detailed information.

6.9 Remaining time and Display messages

During the analysis, these symbols are displayed for each reading channel. These symbols
change following the reading of the sample and inform the operator on the remaining time. The first
symbol means that the sample has just been inserted, the second one means that the analysis has just
started and so on. If the 2nd hour result is active, on the display will appear alternatively the result
obtained after 1 hour and the result obtained after 2 hours. Results can be recognized by these symbols:

1 hour results (obtained after 30 minutes) are introduced by the symbol

2 hours results (obtained after 60 minutes) are introduced by the symbol

Meaning of other symbols on display

----------------------------------------------
"xxx" Result = xxx
" . " Awaiting sample
">xxx" Sample value higher than "xxx"
"lev" Error: initial level error
"rem" Error: removed sample

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7 MEASURING PRINCIPLE

legend :

P P) test tube support

H) infrared Tx-Rx
BARCODE

hight position

L) infrared Tx-Rx
low position
R) red blood cells
S) plasma
C) course of detectors
K) distance from bottom
test tube and infrared
low position
S L1) course of initial level
H
(at time zero)
L2) course of level after
R C
L1 30 minutes
L2 l3) course of level after
L3 60 minutes
L
K

Figure 7

7.1 Instrument Calibration

Each instrument is calibrated by the manufacturer using specific calibrators. The calibration of each
instrument is traceable from the serial number of the instrument.

7.2 Survey Method

The ESR reading principle used by the instrument is schematized in Fig.7.

The infrared transmitter-receiver pair covers area C of the test tube. The end points of the movement are: L for
the lower and H for the upper. During movement from L to H the infrared ray cannot strike the receiver
because it is obstructed by the high number of erythrocytes. As soon as the ray comes out of the cells, the
receiver captures the signal and transmits a signal to the computer which note the steps required by the motor
to reach the level of the moment.
L1 represents the steps for the erythrocyte level at zero time and L2 the steps for the level after 30'.
K also represents the steps necessary to reach the lower part of the test tube from which the red corpuscles
column begins. Even if the test tubes constantly draw the same quantity of blood,the blood level in the test
tube may be subject to slight variations depending on the sample.
To compensate this variation within certain limits the instrument adopts the principle of the percentage of
sedimentation with regard to the initial level L1.

7.3 Results correction to 18°C

The obtained results are correlated to the method of reference related to the room temperature. THE
ANALYZER, constantly measuring the analysis temperature, further reconverts the values obtained to the

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User Manual ESR Automated analyzer – 12 Channels

reference one of 18 degrees using the Manley table (1) thus ensuring better reproducibility instead of analyses
performed at different temperatures.

(1) Manley table

correct
values ------------ analysis temperatures -----------------------
____ _____________________________________________________________
18 degrees C. 15 degrees C. 18 degrees C. 20 degrees C. 25 degrees C. 30 degrees C.

5 4 5 5 6 8
10 9 10 10 12 16
20 18 20 21 25 31
30 27 30 31 37 45
40 36 40 42 49 58
50 46 50 52 60 71
60 55 60 62 71 82
70 63 70 72 82 93
80 72 80 82 93 104
90 81 90 93 103 114
100 90 100 103 114 125

The Analyzer converts the results to 18 degrees as per the table if analysis room temperature is between 15
and 32 degrees C.
For lower or higher room temperatures the instrument's conversion limits are: 15 degrees for lower
temperatures and 30 degrees for higher.

8 MAINTENANCE

Due to component parts simplicity, the Analyzer does not require special maintenance. The most sensitive part
is the infrared sensors inside the instrument.
Pay attention to the cleanliness of reading plate: when not used, it must be covered with the dust cover
supplied along with the reader.
Do not clean the reading plate with liquids.
The entry of liquids or solid material into channels can cause considerable damage to the instrument.

8.1 Cleaning Instructions

Dust can be removed using an ordinary vacuum cleaner.

It is advisable to clean once a month the instrument externally with a disinfectant solution to reduce the
microbial contamination. Concerning test tubes, they must remain well closed and the cap should absolutely
not be removed. The label must be correctly positioned and well stuck to the test tube surface. Label
fragments could fall into the test tube and obstruct a correct reading function during analysis.

9 ASSISTANCE
In case of malfunctioning of the instrument, assistance can be made only by authorized personnel.
Only technicians with a certificate which states that they have followed an assistance course in Vital
Diagnostics or made by a Vital Diagnostics authorized person, can operate assistance on the
instruments.
If a technician is not available, defective instruments can be sent to Vital Diagnostics after calling the
technical service.

Vital Diagnostics technical service: +39 0543 721220

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10 TROUBLESHOOTING GUIDE

ALARM CAUSE REMEDY

lev a) sample level high or low a) repeat sample collection
b) the label is in a bad position b) replace label and repeat analysis
rem sample has been removed re-insert sample
Thermometer error "T.ERR" Themperature sensor malfunction Replace driver board
System stopped motor or mechanical defect Replace motor or complete group
Data result is not printed Printer setting turned off a) Check dip switch setting
Printer cable b) Check cable
Printer malfunction c) Replace printer
Data result seem to be wrong a) sample clot a) repeat sample collection
b) sample has foam b) re-mix gently
c) sample measured after 4
hours from sample collection
d) bad sample mixing

11 RESIDUAL RISKS
Despite of the measures taken in the designing of the machine to guarantee a safe use of it, there might
happen reasonably predictable occurrences, whose risk was possible to reduce, but not to eliminate
completely.

RESIDUAL RISKS PROTECTION MEAUSRES

The operator must wear always gloves and

Biological contamination protection glasses, as prescribed by laboratory
regulations. Do not ever open tubes

Insert and remove tubes from holes

Tubes breaking maintaining a vertical position, without
applying lateral forces.

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12 PERFORMANCE CRITERIA AND LIMITATIONS

12.1 Performance Criteria

A. Mechanical/ Optical precision of detection: +/- 0.2 mm (Software controlled by encoder

resolution)

B. Reproducibility of analysis: C.V. < 5 % (sample’s depending)

C. Automatic temperature conversion Accepted range:

to 18°C. ( Manley table ): Range 15° - 32° C.

D. Level range for correct analysis: - 10 + 4 mm from normal

E. 2 measuring points: Initial and Final

F. Measuring range: 1 - 140 mm/h

G. Results pre-indication : after 12 minutes

12.2 Limitations

A. Strongly lipemic or haemolytic samples may alter reading capability.

B. Sed rate values > 140 mm/h will be indicated with this mark only.

C. Temperatures outside the given range will be accepted as 15 ° min and 32° max

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13 TECHNICAL SPECIFICATIONS

Area of application: Blood sedimentation rate analysis

Operating Conditions: temperature 15° - 32°C room temperature

humidity: 45% - 85%

Tube employed GE011B / GE011V / GE011C

Analysis time: 30' or 60’

Loading capacity: max 12 samples at a time

Analytical capacity: max 24 tests/h

Loading pattern: random

Results: mm/1h ; mm/2h Westergren (by interpolation)

Temperature correction: automatic compensation referred to 18° C (Manley)

Measuring method: infrared

Reading resolution: +/- 0,2 mm

Results resolution: +/- 1 mm

Display: LCD display with backlight

Interface: RS 232 for printer

Instrument size: Height 200 mm

Width 240 mm
Depth 260 mm

Weight: about 3.5 kg

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14 EC DECLARATION

DICHIARAZIONE DI CONFORMITÁ CE
EC DECLARATION OF CONFORMITY

conforme all’Allegato III della Direttiva 98/79/CE Dispositivi Medico-Diagnostici In Vitro

conforme all’Allegato II della Direttiva 2006/42/CE Direttiva Macchine
according to Annex III of the Directive 98/79/CE In Vitro Diagnostic Medical Devices
according to Annex II of the Directive 2006/42/CE

fabbricante
Vital Diagnostics S.r.l.
manufacturer
Via Balzella 41/G/4
indirizzo
47100 FORLI’
address
ITALIA
telefono fax
0039 0543 721220 0039 0543 796001
phone fax
Identificazione dei prodotti Analizzatore Automatico della VES
Product identification ESR Automated Analyzer
Nome commerciale
SEDY-12
Brand name
Numero/i di catalogo
PRD-ESR-EL12XXX
Part number/s
classificazione dei prodotti dispositivi diversi da quelli elencati nell’Allegato II della Direttiva 98/79/CE
product identification devices other then those mentioned in Annex II of the Directive 98/79/EC
Si dichiara sotto la propria responsabilità che
i dispositivi sopraelencati rispettano le disposizioni applicabili delle seguenti direttive:

Hereby we declare under our sole responsibility that

the above mentioned devices meet the applicable provisions of the following Directives:

Direttiva 98/79/CE
Direttiva 2006/42/CE
Direttiva 2004/108/CE (Compatibilità Elettromagnetica)
Direttiva 2006/95/CE (Bassa Tensione)
Direttiva 2002/96/CE e 2003/108/CE (RAEE)
Direttiva 2002/95/CE (RoHs)

Tutta la documentazione tecnica comprovante il rispetto dei requisiti applicabili delle Direttive elencate,
è conservata a cura del Fabbricante

All the technical documents required to demonstrate the conformity to the listed Directives,
are kept by the Manufacturer

luogo e data anno di immissione in commercio

Forlì, 27/02/2009 2001
place and date year of introduction on the market
firma
signature

timbro della Società

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15 DISPOSAL AND RECYCLING

Herewith we declare that this instrument is subject to the European Directive 2002/96/EC (RAEE
Directive).
Therefore the instrument must be disposed separately, not as urban waste and delivered to the specific
collection center in according to the Directive 2002/96/EC.
The user can ask to the dealer the collection of the instrument if a new instrument is ordered to replace
the old one.
On the instrument there is a label with the symbol shown in this page. The symbol means that the
instrument can not be disposed as urban waste.

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APPENDIX

A The Erythrocyte Sedimentation Rate

Principles of Analysis and Current Usage: The Erythrocyte Sedimentation Rate (ESR) measures the
rate of settling of erythrocytes in their native anti-coagulated plasma. Sedimentation occurs in three
stages: (1) rouleaux formation, (2) sinking of rouleaux at a constant speed, and (3) slowing of
sedimentation as the cells begin to pack.
The length of the fall of the meniscus of the red cell column (measured from the plasma
meniscus) in a unit time is the ESR.
Mechanism of Erythrocyte Sedimentation Rate
The erythrocytes in suspension repel each other because of their negatively charged surface sialic acid
(the z-potential), but increasing amounts of asymmetric macroglobulins, mainly fibrinogen and to a lesser
extent gamma globulins, weaken the repellent forces between adjacent erythrocytes, so that rouleaux
and aggregate formation take place albeit slowly. Since the red cell rouleaux and aggregates have a
relatively large volume, they settle faster than single cells.
The ESR depends on several factors.
1. Plasma factors: Proteins other than fibrinogen and c-globulins also influence the ESR; such as
albumin, retard it, whereas others like "a" and "b-globulins" increase it. The fact that fibrinogen is one of
the acute-phase reactants robs the test of its diagnostic specificity and renders it responsive and
sensitive to a wide variety of abnormal states. Increasing IgM levels in macroglobulinemia are
responsible for maximal rouleaux formation and, at the same time, for increasing plasma viscosity. The
latter tends to retard the ESR and may eventually reach a point where the viscosity exceeds the
accelerating protein effect, so that a normal or near-normal ESR results. The occurrence of rouleaux
formation associated with normal or near-normal ESR suggests the hyper-viscosity syndrome.
Monoclonal gammopathy as seen in plasma cell or lymphoproliferative disorders stimulates rouleaux
formation, thus accelerating the ESR.
2. Red cell factors: The size and number of erythrocytes play a minor role in the ESR. When
normal cells sediment, the downward force is almost counterbalanced by the upward forces generated by
the plasma within the confines of the sedimentation tube. Changes in the shape and size of red cells,
e.g., in microcytosis, anisocytosis, poikilocytosis, sickling, and acanthocytosis, interfere with their ability
to form rouleaux and aggregates, thus slowing the sedimentation rate. Macrocytosis and anemia
accelerate the ESR, whereas polycythemia causes it to slow down considerably. Heparin accelerates the
rate of the fall of the erythrocytes.
3. Physical factors: The temperature, size, and bore of tube, as well as the angle of the tube during
the test influence the ESR.
Reference and Preferred Methods
The International Committee for Standardization in Haematology (ICSH) has standardized the
Westergren method, because the Wintrobe method has major drawbacks, e.g., the 100 mm tube length
and the narrow bore, which limit readings in excess of 60 mm/hr because of packing of red cells.
Specimen
Collect venous blood in a sodium citrate tube and mix it well. Perform the test within 2 hrs. of drawing,
or within 6 hrs., if the blood is kept at 4°C.
Reference Interval
Male <10 mm/hr
Female <20 mm/hr
Children (<12 years) 3 - 13 mm/hr

Interpretation: Physiologically, the ESR is elevated in pregnancy, in the puerperium, and in 10% of
apparently healthy children.
The test is non-specific but sensitive to inflammation, tissue injury, auto-immune disease and
lymphoproliferative disorders. It has been labeled outdated because of its lack of specificity, but
clinically, a normal ESR gives the assurance that the conditions detected by an abnormal ESR are not
present, though there are reasons to prefer the C-reactive protein test over the ESR.
The ESR is increased in the following conditions:
1. Infections, e.g., tuberculosis, pelvis inflammatory disease, systemic lupus erythematosus, and
rheumatoid and pyogenic arthritis, because of the increase in immunoglobulins and acute-phase
reactants (fibrinogen, haptoglobins, transferrin, ceruloplasmin, and a2-macroglobulins)
2. Relative increase of globulins: conditions that lead to loss of albumin and thus to a relative

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ESR Automated analyzer - 12 Channels User Manual

increase of globulins, e.g., kidney disease, chronic liver disease, and enteritis
3. Absolute increase of globulins, e.g., multiple myeloma, cryoglobulinemia, macroglobulinemia,
and lymphomas
4. Extensive tissue necrosis, as seen in malignant tumours and in myocardial infarction
5. Other conditions, e.g., pregnancy (increase in fibrinogen), menstruation, lead poisoning anemia,
and cirrhosis. (In cirrhosis, depression of albumin production is associated with a polyclonal globulin
increase. Severe hypofibrinogenemia may counteract the accelerated ESR.)
6. Coombs-positive haemolytic anemia (The globulin-coated cells exhibit an increased tendency to
agglomerate.)
7. Unexplained causes (On rare occasions, especially in elderly patients, elevated levels may be
found.)
The ESR is normal or near normal in the following conditions:
1. Haematological disorders, e.g., infectious mononucleosis
2. Localized infection
3. Benign neoplasms
The ESR is decreased in the following conditions:
1. Polycythemia vera (may even be zero)
2. Sickle cell anemia
3. Some forms of macroglobulinemia, e.g., hyper-viscosity syndrome.

Procedure: Erythrocyte Sedimentation Rate.

Reagent and equipment:
1. Sodium citrate solution
2. Westergren tube (disposable, glass)
3. Tube-holding device

B DIP SWITCH CONFIGURATION

On the rear side of the Instrument there are 4 DIP-SWITCHES. They enable/disable the followinf
functions: have a specific function :

N° POS FUNCTION POS FUNCTION

1 ON WORKING TIME 60’ OFF WORKING TIME 30’
2 ON PRINTER ENABLE OFF PRINTER DISABLE
3 ON AUTOPRIN SEDIM. GRAPH OFF NO SEDIM. GRAPH
4 ON TEMP. CONVERSION ON OFF TEMP. CONVERSION OFF

DIP SWITCH N° 1 define the working time:

When set on the OFF position results are obtained and displayed after 30 minutes. Results are
expressed in 1 hour Westergren.
When set on the ON position, results are obtained and displayed after 30 and 60 minutes. Results are
expressed in 1 and 2 hours Westergren.

DIP SWITCH N° 2 enables/disables the printer.

DIP SWITCH N° 3 enables/disables the sedimentation curve graph.

When set on the ON position, at the end of the analysis, the sedimentation curve will be printed out (Of
course this function requires a printer connected and enabled).
When set on the OFF position, the sedimentation curve won’t be printed out.

DIP SWITCH N° 4 enables/disables the correction of results to the temperature of 18°C.

When set on the ON position, results will be corrected to the reference temperature of 18° C.
When set on the OFF position, results will be referred to room temperature, therefore results will show
the effects of temperature variation.

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