Diesse cube 30 touch User manual

USER MANUAL
Rev. 1.1 July 2018
Automated instrument for ESR determination
with modified Westergren method
Only for in vitro diagnostic use

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MANUFACTURER
DIESSE DIAGNOSTICA SENESE S.p.A.
Via delle Rose 10, 53035 Monteriggioni (SI), Italy
Tel. ++39 0577 587111 Fax. ++39 0577 318690
WWW.DIESSE.IT
REGISTERED AND ADMINISTRATIVE OFFICE
Via A. Solari 19, 20144 MILANO,
Tel. ++39 02 4859121 Fax. ++39 02 48008530
For technical assistance please contact your distributor:

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CUBE 30 touch accessories
Catalogue code
Description
10293
Test device NEXT 500 (500 tests)
10294
Test device NEXT 1K (1000 tests)
10296
Test device NEXT 5K (5000 tests)
10297
Test device NEXT 10K (10000 tests)
10403
Thermal paper
20550510
External barcode reader
LIST OF MANUAL REVISIONS
REV. USER
MANUAL (0448)
DESCRIPTION OF CHANGES
1.0 of 03/2018
Initial revision
1.1 of 07/2018
Description of new functions of settings - Troubleshooting update

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Applied directives and regulations:
-Directive 98/79/EC on in vitro diagnostic medical devices
-2014/35/EC “Low voltage directive”
-2014/30/EC “Directive on the harmonisation of the laws of the Member States relating to
electromagnetic compatibility”
-2011/65/EU “Directive on the restriction of the use of certain hazardous substances in
electrical and electronic equipment –RoHS2”
-EN 61010-1 “Safety requirements for electrical equipment for measurement, control
laboratory use –Part1: General requirements (CEI 66-5)”.
-EN 61010-2-081 Safety for electrical equipment for measurement, control, laboratory use
–Part 2-081: Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes (CEI 66-8)”.
-EN 61010-2-101 “Safety for electrical equipment for measurement, control, 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”
-UNI EN ISO 18113-3 Information supplied by the manufacturer (labelling) - Part 3: in vitro
diagnostic instruments for professional use
-UNI CEI EN ISO 14971:2012 –Medical devices –Application of risk management to
medical devices.
-EN ISO 80000-1:2013 Quantities and Units - Part 1: General
No page in this manual may be reproduced in any form or by any means, electronic, mechanical or
otherwise, for any use whatsoever without prior written permission from DIESSE DIAGNOSTICA
SENESE S.p.A.

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SYMBOLS
Legend of symbols used:
The instrument meets the requirements of the European Directive on in vitro
diagnostic medical devices (98/79/EC).
In vitro diagnostic medical device
Date of manufacture
Serial number
Manufacturer
Legend of electrical and safety symbols used.
Earthing
Obligation of separate waste collection according to 2012/19/EU directive
Attention, read the guide, follow the safety symbols.
Caution: risk of electric shock
Legend of symbols used in this document.
WARNING: potential risk of personal injury; all the conditions indicated in the
relative text must be read and understood before proceeding.
CAUTION: potential risk of damage to the instrument; all the conditions indicated
in the relative text must be read and understood before proceeding.
Caution: important information.
BIOHAZARD: risk of contamination with potentially infected substances.
Instrument that complies with MET standards for the Canadian and US markets

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LIMITATIONS AND WARNINGS
Before installation and use of the instrument, for proper and safe use, it is advisable to read
carefully the warnings and instructions in this user manual. It is important that this user manual
be kept together with the instrument for future reference.
In the event of sale or transfer, make sure that this manual accompanies the instrument to allow
new users to be informed about the instrument’s functions and the related warnings.
It is recommended to allow only qualified and skilled personnel to use the instrument.
The safety and performance requirements of the instrument are no longer guaranteed
when the instrument is powered using a different cable type from the one supplied,
which is compatible with the power supply of the country of installation.
BIO-CONTAMINATION HAZARDS
Potentially infected material may be handled. When analyzing patient samples, all
precautions must be taken regarding biological risks. The samples do not require
preparation. The samples must be disposed of in accordance with laboratory
instructions and with local laws.
Observe personal and group safety measures required for the operator and
appropriate for the work environment. Comply with directives on safety and with
applicable laws in force.
In the case of leakage of biological material, during the working cycle, use 70%
isopropyl alcohol to clean external surfaces of the instrument using appropriate
personal protective equipment and observe regulations on sanitization.
All supplied materials must be disposed of in accordance with local laws.

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TABLE OF CONTENTS
INTRODUCTION..........................................................................................................................9
PRESENTATION OF THE INSTRUMENT ......................................................................................................9
CLINICAL SIGNIFICANCE OF ESR ..........................................................................................................10
NORMAL ESR VALUES (WESTERGREN CITRATED)......................................................................................11
MATERIALS REQUIRED FOR USE OF THE INSTRUMENT .................................................................................12
WARNINGS................................................................................................................................12
DECONTAMINATION PROCEDURE ................................................................................................12
EXTERNAL CLEANING OF THE INSTRUMENT .............................................................................................13
TECHNICAL DATA....................................................................................................................14
TECHNICAL DESCRIPTION ..................................................................................................................14
EXTERNAL CONNECTIONS OF THE INSTRUMENT ........................................................................................15
UPDATING SOFTWARE .....................................................................................................................16
TECHNICAL FEATURES ......................................................................................................................16
INSTRUMENT COMPOSITION ..............................................................................................................17
UNIT OF MEASURE..........................................................................................................................17
INSTALLATION .........................................................................................................................18
TRANSPORT AND HANDLING ..............................................................................................................18
PACKAGING CHARACTERISTICS ............................................................................................................18
MATERIALS PROVIDED .....................................................................................................................19
UNPACKING THE INSTRUMENT............................................................................................................20
ENVIRONMENT..............................................................................................................................20
INSTALLATION PROCEDURE ................................................................................................................21
DISPOSAL ....................................................................................................................................22
USE............................................................................................................................................23
SAMPLE PREPARATION.....................................................................................................................23
TEST TUBE COMPATIBILITY ................................................................................................................23
TEST TUBE LABELING .......................................................................................................................24
MENU DESCRIPTION........................................................................................................................26
HOME.......................................................................................................................................27
PERFORMING AN ANALYSIS CYCLE................................................................................................28
INSERTING THE TEST TUBES................................................................................................................30
STARTING THE ANALYSIS CYCLE ...........................................................................................................30
INSERTING A NEW SAMPLE (RANDOM ACCESS).........................................................................................33
ARCHIVE........................................................................................................................................................................................37
SETTINGS ..................................................................................................................................38
QUALITY CONTROL .................................................................................................................41
QC REGISTRATION PROCEDURE...........................................................................................................41
Performing QC analysis..........................................................................................................................................................42
QC ARCHIVE...............................................................................................................................43
USER MANAGEMENT...............................................................................................................45
TROUBLESHOOTING ...............................................................................................................49

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CONNECTION TO HOST COMPUTER......................................................................................51
BIBLIOGRAPHY ........................................................................................................................53

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INTRODUCTION
Presentation of the instrument
he CUBE 30 touch (Fig.1) is an instrument designed to
measure the erythrocyte sedimentation rate (ESR) of blood
samples anticoagulated with EDTA, directly from the EDTA
tube in only 20 minutes. The instrument can analyze a load of
30 samples at once or on a random access and continual
loading basis. By analysing the sample directly from the EDTA
blood collection tube, multiple samples or sample transfers are not necessary.
With its colour touch screen, the user can select various instrument functions,
which are described in more detail inthefollowing sections. The analysis is fully
automated (mixing and reading) and the results provide excellent correlation to
the one-hourWestergren reference method.
Fig. 1
Chapter
1
T

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The instrument is designed to have temperature correction enabled at alltimes;
it relates the results to a temperature of 18°C according to Manley’s
Nomogram. However, it is possible to de-select temperature correction
according to laboratory needs.
Manley’s Nomogram
Clinical significance of ESR
The erythrocyte sedimentation rate test measures the distance travelled by red
blood cells in autologous plasma over a certain period of time. In normal
conditions, red blood cells tend to move apart reciprocally due to the presence
of negative electric charge from the numerous residues of sialic acid present at
a membrane glycoprotein level. When the protein composition of plasma
changes with the production of “acute phase proteins” at a hepatic level,
following an inflammatoryprocess or tissue damage, the bond of these proteins
(fibrinogen, immunoglobulins) with the surface of the red blood cells alters the
negative charge of the membrane potential (Z) and the red blood cells can
bind, forming a rouleaux pattern. These rouleauxed cells aggregate to form
microspheres of a uniform radius, which start to sediment when their density
exceeds that of plasma. The ESR value goes up in all cases where there is an
increase in acute phase proteins, in particular fibrinogen (which is considered

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to account for 70% of the sedimentation phenomenon), and immunoglobulins
(which increase in the case of oncological/hematological diseases and acute
infections). ESR is therefore a non-specific measurement of an inflammatory
state; the rate is high in various pathological conditions such as inflammatory
diseases (infections, rheumatic diseases), a relative/absolute increase in
globulins (nephrotic syndrome, myeloma), tissue necrosis (myocardial
infarction, tumours). ESR is useful for predicting a diagnosis of some diseases,
such as polymyalgia rheumatica, temporal arteritis, rheumatoid arthritis and
Hodgkin’s disease, and is useful as an effective marker for pharmacological
treatment in many diseases such as rheumatoid arthritis, vasculitis,
collagenosis and septic arthritis. The erythrocyte sedimentation rate is usually
higher in women compared to men, increases in pregnancy, and tends to rise
with agein both genders.
Normal ESR values (Westergren citrated)
With the Westergren reference method, the test is performed on blood diluted
in citrate, with 4 parts blood to one part anti-coagulant. The diluted blood is then
aspirated inside a special, graduated, 2.5-mm diameter pipette and kept
upright. The erythrocyte sedimentation level is recorded after exactly one hour,
measuring the distance between the lower side of the plasma meniscus and
the meniscus of the sedimented red blood cells.
Guidelines for ESR Reference Values for the Westergren ESR Method* are
as follows:
Normal 0-20mm/hr
* Follow CLSI Procedures for the Erythrocyte Sedimentation
Rate Test; Approved Standard. CLSI document H02.
Reference values should be established locally in accordance with the
individual laboratory’s accrediting agencies. Refer to CLSI document H02
for age and gender-specific reference values.

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A doctor must interpret the clinical significance of an ESR value obtained from
abnormal samples, including but not limited to icteric or lipemic samples,
samples with anemic conditions, low hemoglobin concentrations, hemolysis, or
any other pathological condition which can interfere or impede a clear reading
of the sedimentation. ESR testing performed on anomalous samples using
manual or automated methods are subject to a high degree of variability. In the
CUBE 30 touch, these samples may be undetected or they may yield varying
results; for this reason, a visual inspection of the sample at the conclusion of
the test is recommended, to verify the presence of a clear interface between
the plasma and sedimented cells.
Materials required for use of the instrument
To use the instrument, materials must come exclusively from those
manufactured by DIESSE DIAGNOSTICA SENESE S.p.A. (Always read the
instructions for use which accompany each product before its use); any other
part or accessory used in the instrument may cause damage or incorrect
results. The manufacturer therefore declines all responsibility for damages
deriving from inappropriate use.
WARNINGS
While the CUBE 30 touch system provides a high level of safety in handling
biological samples, please take all necessary precautions when handling
potentially infected material. Waste material at the end of the cycle must be
processed in accordance with the local waste requirements.
DECONTAMINATION PROCEDURE
The CUBE 30 touch has been designed and constructed to require minimal
maintenance.
Before any maintenance work:
-Power off the instrument and disconnect it from the power source.

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-Use appropriate personal protective equipment during operation.
In the event of biological material leakage during the operating cycle, clean the
outer surfaces of the instrument with 70% isopropyl alcohol and contact
Technical Services immediately.
External cleaning of the instrument
Periodic external cleaning is recommended.
1. With the instrument switched off, clean the instrument with a liquid
disinfectant used in the laboratory and leave it to dry. For the touch
screen use a dry microfibre cloth.
2. Repeat the operation with 70% isopropyl alcohol.
3. Leave the instrument turned off for at least 1 hour before starting a new
operating cycle or carrying out anyother operation on the instrument.
Do not attempt to remove any screws or access the interior of the instrument.
For assistance with the interior of the instrument which is not readily accessible
to the operator, contact Technical Services.
DECONTAMINATION
PROCEDURE:

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TECHNICAL DATA
Technical description
Fig. 2
The CUBE 30 touch consists of a single body containing all the operating
functions necessary for analyzing the sample.
The instrument has 30 positions arranged in two concentric circles of 15
positions each. The test tube carousel is equipped with a plastic adaptor
carousel; required for use with EDTA tubes with conventional closure.
Chapter
2
Test Tube Carousel

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A motor lifts the reading unit, which uses 2 optical sensors to verify the
suitability of the sample and detect the level at time zero and at the end of
sedimentation.
Sample detection happens after the cycle has been started, through the
optical sensors. The instrument carries out a scan of the test tube inserted
in each position, verifying that it contains an adequate volume of blood.
Sample identification is done by an internal barcode reader which reads the
barcode when a sample is detected by an optical sensor. The sample ID code
may be manually entered with a virtual keyboard or by using an external
barcode reader (accessory).
The function of the acoustic warning is to alert the operator during various
stages of the operating cycle or in the event of errors.
This sensor is used to measure the temperature and is fitted in proximity of
the test tube carousel.
The analysis results are printed at the end of each operating cycle or
working session.
Results transmit to the LIS automatically upon completion of the 20-minute
test and/or can be viewed in the Tube view.
External connections of the instrument
The power connector is on the back of the instrument (Fig. 3).
Fig.3
The ON/OFF switch is on the left side of the instrument’s base (Fig.4).
Reading Unit
Sample Detection
Sample
identification
Acoustic
Warning
Temperature Sensor
Printer
LIS
Fig.4

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There are four connection ports on the right side of the instrument’s base.
Two connectors for a Computer/HOST: one is a Serial RS232 (9pin)
type; the other is an USB b-standard type.
A connector for an external barcode reader (EXT. BC).
A USB a-standard port for connecting to a USB mass storage device
(usable for software updates and exporting files) (Fig.5).
Updating software
Updating software is a simple, direct procedure:
-Download the softwarefrom the site www.diesse.it
-Save onto a USB mass storage device
-With the instrument switched off, insert the USB device into the
appropriate port (Fig.6)
-Power on the instrument and wait for a few seconds. The instrument
will update automatically.
Technical features
USE
Internal use
POWER SUPPLY
Europe: 230Vac@50Hz;
USA/Canada: 110-120Vac@60Hz
Power output: 100VA
DIMENSIONS (mm)
310x470x403 (l x w x h)
WEIGHT
15 kg
TEMPERATURE
15-35°C (operating)
5-45°C (storage)
RELATIVE HUMIDITY
(RH)
20%-80% without condensation
ALTITUDE
up to 2000 metres
NOISE LEVEL
below 80 decibel
POLLUTION LEVEL
2 pollution degrees
MEASUREMENT
RANGE
0 to >140 mm/hr
CENTRAL UNIT
ARM Cortex-M4 180 MHz Microprocessor
DISPLAY
10.1” vertical, wide
OPTICAL UNIT
2 pairs of optical elements
INTERFACES
USB Host; USB Client; 2x RS232
Fig.5
Fig.6

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PROTECTION CLASS
I
SAFETY STANDARDS
IEC 61010-1; IEC 6101-2-081; IEC 61010-2-101
CSA C22.2 No. 61010-1-12 / UL 61010-1:2012
EMC
EN 61326-1/EN 61326-2-6
INSTALLATION
CATEGORY
II
Instrument composition
The instrument is composed of the following materials expressed in
percentages:
Material in %
CUBE 30
TOUCH
IRON
60
COPPER
3
ALUMINIUM
10
PLASTIC MATERIALS (PVC, ABS...)
20
SILICON
2
Gold
0.1
Tantalum
0.2
Cadmium
0.2
Others (No Latex)
4.5
Unit of measure
The units of measure are expressed according to the INTERNATIONAL
MEASURING SYSTEM as indicated in the technical standard CEI EN ISO
80000-1:2013.

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INSTALLATION
The CUBE 30 touch is a precision instrument and must handled as such.
Inappropriate operations may damage the internal optoelectronic components
and cause mechanical damage. Follow the instructions in this chapter in order
to ensure the safety of the instrument and of the operator.
Transport and handling
The instrument must be transported and handled in its original packaging. Do
not let the instrument or packaging become wet or be exposed to a damp
environment. If the packaged instrument has been exposed to storage or
transit temperatures below 10°C for more than 24 hours, allow the unit to stand
at room temperature for one hour prior to installation.
Packaging characteristics
The instrument is packed in:
1. an external cardboard box
2. moldedhousing in CFC- and HCFC-free, closed-cell polyethylene foam
External packaging
dimensions
600x400x520
mm:
4,0
Kg
Chapter
3
Keep the original
packaging
including the
materials
supplied in Fig 7.

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Materials provided
The CUBE 30 touch is supplied with the following materials:
User Manual
One power cable adherent to IEC International Standards (Female
Plug IEC 320 C-13; Male Plug Schuko EEC 7-VII; Rating: 10A / 250V
AC).
One power cable SVT PLUG USA/OUTLET VDE UL 2mt
Two Delayed 5x20 mmUL fuse blocks 10A
USB cable
Plastic Adaptor (A in Fig. 7) for use with conventional stopper EDTA
tubes
Touch screen stylus; “CUBE pen”
Inspection Certificate
USB key
Packing list
Fig.7

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Unpacking the instrument
1. Open the box from the top.
Fig. 8
2. Remove the block ofpolyethylene foam covering the instrument.
3. Remove the accessories stored inside.
4. Remove the instrumentfrom the box.
Fig. 9
5. Remove the protective bag which wraps the instrument.
6. Verify that the packing list and supplied materials match.
Environment
For normal safety requirements and given the type of testing it performs, the
instrument must be positioned in a dust-free environment away from heat
sources, and free from any exposure to liquids. Position the instrument on a
perfectly level bench, not subject to shaking or vibrations. Observe a 15 cm or
6” perimeter around the instrument as a safety precaution. In addition, it is