Diesse cube 30 touch User manual

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USER MANUAL
Rev. 2.3
Automated instrument for ESR determination
with modified Westergren method
Software version 2.xx.xx
FOR IN VITRO DIAGNOSTIC USE ONLY

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This page is intentionally left blank.

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CUBE 30 TOUCH models:
This manual is applicable to the following CUBE 30 TOUCH instrument models:
Catalog number
Description
10395 CUBE 30 TOUCH
CUBE 30 TOUCH Accessories:
Catalog number
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
10435-10436 ESR Control CUBE

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Manual revisions list:
MANUAL revisions
Description of changes
1.0 - 03/2018
Initial revision
1.1 - 07/2018
Description of new functions of settings - Troubleshooting update
1.2 - 01/2019
Addition of Rx symbol; insertion of Intended Use and Performances
sections
1.3 - 02/2019
“Capillary blood” phrasing removed from Intended Use, added
“semiquantitative” in Intended Use
1.4 - 06/2020
Corrected typing mistake in Chapter 4 (fill volume)
1.5 - 07/2021
Update due to new graphic design.
Added section for:
-fusible replacement;
-printer paper roll replacement;
-ordinary cleaning.
Update of the warnings section.
2.0 - 03/2022
Update due to new software release 2.01.00
2.1 – 05/2022 Update of the intended purpose
2.2
Update of:
-list of accessories
-technical features (power input)
-label layout
-installation procedure
-sample preparation procedure
-quality control paragraph
-references
2.3 Disclaimer added at Paragraph 2.1

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Manufacturer
DIESSE DIAGNOSTICA SENESE SpA
Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy
Tel. [phone], Fax. + 39 0577 307106
www.diesse.it
TECHNICAL SUPPORT
Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy
Tel. [phone], Fax. + 39 0577 307106
Numero Verde: 800 606932
e-mail: technicalsuppor[email protected]
If any serious incident in relation to this device has occurred in the European Union
market territory, please report without delay to the manufacturer and competent
authority of your Member State.
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:
Key of graphic symbols
Instrument meeting the requirements of the EC Directive 98/79 on in
vitro diagnostic medical devices.
In vitro diagnostic medical device
Manufacturing date
Serial number
Manufacturer
Instrument that complies with MET standards for the Canadian and US
markets
Key of electric and safety symbols
Protective conductor
WEEE: Waste electrical and electronic equipment – Separate Collection
is required pursuant to Legislative Decree No. 49 of March 14. 2014
(Italy), on “implementation of Directive 2012/19/EC.”
Attention: please read this manual carefully and comply with the safety
symbols.
Caution: risk of electrical shock
Key of graphic 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.
N.B. important information.
BIOHAZARD: risk of contamination with
potentially infected
substances.

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LIMITATIONS AND WARNINGS
Before installation and use of the instrument, for proper and safe use, it is advisable to
carefully read 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 laboratory personnel to use the
instrument.
The safety and performance requirements of the instrument can no longer
be guaranteed when the instrument is powered using a different cable from
the one supplied, 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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Content
1INTRODUCTION..............................................................................................................................................................10
1.1 Intended purpose................................................................................................................................ 10
1.2 Presentation of the instrument ................................................................................................... 10
1.3 Clinical significance of ESR...............................................................................................................11
1.4 Normal ESR values (Westergren citrated)...............................................................................12
1.5 Materials required for use of the instrument.........................................................................13
1.6 Warnings ...................................................................................................................................................13
1.7 Personal protective equipment (PPE).......................................................................................13
1.8 Ordinary maintenance.......................................................................................................................13
1.8.1 Cleaning and decontamination procedure....................................................................... 14
2TECHNICAL DATA.......................................................................................................................................................... 15
2.1 Technical description..........................................................................................................................15
2.2 External connections of the instrument ..................................................................................16
2.3 Updating software ...............................................................................................................................17
2.4 Technical features ............................................................................................................................... 18
2.5 Instrument composition...................................................................................................................19
2.6 Unit of measure .....................................................................................................................................19
2.7 Instrument label....................................................................................................................................19
3INSTALLATION ................................................................................................................................................................. 21
3.1 Transport and handling.....................................................................................................................21
3.2 Packaging characteristics................................................................................................................21
3.3 Materials provided................................................................................................................................21
3.4 Unpacking the instrument.............................................................................................................22
3.5 Environment...........................................................................................................................................23
3.6 Installation procedure...................................................................................................................... 24
3.7 Disposal.................................................................................................................................................... 24
3.8 Replacement of the fuses ...............................................................................................................25
3.9 Printer paper replacement procedure.....................................................................................26

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4USE .........................................................................................................................................................................................28
4.1 Sample preparation............................................................................................................................28
4.2 Test tube compatibility.....................................................................................................................28
4.3 Test tube labelling...............................................................................................................................29
4.4 Home page...............................................................................................................................................31
4.5 START Performing an analysis cycle..........................................................................................33
4.5.1 Inserting the test tubes ................................................................................................................ 35
4.5.2 Starting the analysis cycle........................................................................................................... 35
4.5.3 Type of tube.......................................................................................................................................... 39
4.5.4 Inserting a new sample (random access) .........................................................................42
4.5.5 Results..................................................................................................................................................... 44
4.5.6 Guided reading of the printed results................................................................................. 45
4.5.7 Interruption of a work session..................................................................................................48
5Archive .................................................................................................................................................................................49
5.1 Sample archiving functionality ................................................................................................... 50
5.1.1 ‘Export’ button......................................................................................................................................... 50
5.1.2 Samples selection ................................................................................................................................. 53
6Settings................................................................................................................................................................................56
7QUALITY CONTROL .....................................................................................................................................................60
7.1 QC registration procedure............................................................................................................. 60
7.2 Performing QC analysis.....................................................................................................................61
7.3 QC archive................................................................................................................................................62
8USER MANAGEMENT.................................................................................................................................................67
9TROUBLESHOOTING..................................................................................................................................................70
9.1 Temperature out of range................................................................................................................71
10 CONNECTION TO HOST COMPUTER ..............................................................................................................73
11 PERFORMANCES..........................................................................................................................................................74
11.1 CUBE 30 TOUCH precision ............................................................................................................ 74
11.2 CUBE 30 TOUCH correlation..........................................................................................................75
12 BIBLIOGRAPHY..............................................................................................................................................................77

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1INTRODUCTION
1.1 Intended purpose
The CUBE 30 TOUCH is an automated instrument for the quantitative Erythrocyte
Sedimentation Rate (ESR) determination with the modified Westergren method using
venous whole blood anticoagulated with K2EDTA or K3EDTA.
ESR is a non-specific parameter of an inflammatory status, used as an aid for the
monitoring of the physiological or pathological state of the patient.
The instrument is to be used only by professional laboratory users.
1.2 Presentation of the instrument
The CUBE 30 TOUCH (Figure 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, modify Westergren method (Ref.13) 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 color touch screen, the user can select
various instrument functions, which are described in more detail in the following
sections. The analysis is fully automated (mixing and reading) and the results provide
excellent correlation to the one-hour Westergren reference method (Ref. 1-10).
The maximum system capacity is 60 results per hour.
Figure 1 - CUBE 30 TOUCH
The instrument is designed to have temperature correction always enabled; it relates
the results to a temperature of 18°C according to Manley’s Nomogram (Figure 2).

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However, it is possible to de-select temperature correction according to laboratory
needs.
Figure 2 - Manley Nomogram
1.3 Clinical significance of ESR
The erythrocyte sedimentation rate test measures the distance travelled by red blood
cells over a certain period. 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 inflammatory process 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 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

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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 age in both
genders (Ref. 25).
1.4 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.
International guidelines identify 3 ranges of ESR: low (ESR <20 mm/hr), medium (20 <ESR
<60 mm / hr) and high (ESR> 60 mm/hr) (Ref. 16) regardless of gender and age.
The scientific literature attributes the normal value of ESR for the age of less than 50
years between 1 and 15 mm/hr for men and between 1 and 25 mm /hr for women. For
older ages these values increase and they stand in between 1 and 20 mm/hr for men and
between 1 and 30 mm/hr for women (Ref. 18). In pathological conditions these values
can increase up to values of 100 mm/hr and more.
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.
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.

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1.5 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.
1.6 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.
It’s recommended to restart, switch the instrument off and on again, at the end of the
working day to avoid problems of overloading the CUBE 30 TOUCH memory.
1.7 Personal protective equipment (PPE)
Normal use of the instrument does not require the user to come into contact with a
biological sample. In any case, the user must wear personal protective equipment, in
compliance with the laws of his country. PPE consist of at least:
•Gloves
•Safety glasses
•Lab coat
1.8 Ordinary maintenance
The CUBE 30 TOUCH has been designed and built to require minimal
maintenance.
Before any maintenance work:
•Turn off the instrument and disconnect it from the power source.
•Use suitable personal protective equipment during operation.
It is recommended to restart, turning off and on the instrument at the end of the day to
avoid memory overload problems of the CUBE 30 TOUCH.

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1.8.1 Cleaning and decontamination procedure
External cleaning is recommended for safety reasons.
The decontamination procedure must be carried out by the user in the event of
biological material leakage, displacement of the instrument or when deemed necessary.
In the event of biological material leakage during the operating cycle, clean the
external surfaces of the instrument with personal protective equipment.
Decontamination procedure:
1. With the instrument turned off, clean the instrument with a disinfectant liquid
used in the laboratory and allow it to dry. For the touch screen use a dry microfiber
cloth.
2. Leave the instrument turned off for at least 1 hour before starting a new operating
cycle or performing any other operation on the instrument.
For assistance with the inside of the instrument not easily accessible to the operator,
contact Technical Services.

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2TECHNICAL DATA
2.1 Technical description
Figure 3 - Instrument Layout
The CUBE 30 TOUCH consists of a single body containing all the operating functions
necessary for analyzing the sample.
Test Tube Carousel
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.
Reading unit
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
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.

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Sample identification
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 sample must be identified by barcode only. Do not enter any other type of data (e.g.
patient's name and surname), in case of manual entry using the virtual keyboard.
Acoustic warning
The function of the acoustic warning is to alert the operator during various stages of the
operating cycle or in the event of errors.
Temperature sensor
This sensor is used to measure the temperature and is fitted in proximity of the test tube
carousel. In the event that the temperature is outside the operating range described in
paragraph 2.4, the condition is signaled to the user with a message displayed on the
screen.
Printer
The analysis results are printed at the end of each operating cycle or working session.
2.2 External connections of the instrument
The power connector is on the back of the instrument (Figure 4).
Figure 4 - Power connector
The ON/OFF switch is on the left side of the instrument’s base (Figure 5).
Figure 5 - Power button

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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) (Figure 6).
Figure 6 – Connectors for external supports
2.3 Updating software
Updating software is a simple, direct procedure:
•Save the new software into a USB mass storage device
•Save the contents of “cube_30_touch_version_number” folder in a USB memory
device
Note: the folder “cube_30_touch_version_number” depending on the update can
contain:
a. One file: mcfw.bin
b. Two files: mcfw.bin and System folder which contains the graphic object
necessary for the functioning of the instrument.
c. Three files: mcfw.bin, System folder and Help folder that contains the files
necessary to update the instrument help.
The update of the Help is not an automatic procedure, but the user must use the
appropriate function present in the Service. Refer to the Service Manual for
instructions.
•With the instrument switched off, insert the USB device into the appropriate port
Figure 7)
•Power on the instrument and wait for a few seconds. The instrument will update
automatically.
Figure 7 - USB port

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The version number is visible on the Service page
2.4 Technical features
USE
Internal use
POWER SUPPLY
Europe: 230Vac@50Hz;
USA/Canada: 110-120Vac@60Hz
Power input: 100VA
DIMENSIONS (mm) 310 x 470 x 403 (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 meters
NOISE LEVEL below 80 decibels
POLLUTION LEVEL 2 pollution degrees
MEASUREMENT
RANGE
1 - 140 mm/h
1 -90 (for pediatric tube)
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
PROTECTION CLASS
I
SAFETY STANDARDS
EN 61010-1:2010; EN 61010-2-081:2015; EN
61010-2-101:2015
EMC
EN 61326-1:2013; EN 61326-2-6:2013
INSTALLATION
CATEGORY
II
PRINTER
Alphanumeric with 57 mm wide thermal paper, 36
characters / line, speed XX mm / sec.

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2.5 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
2.6 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.
2.7 Instrument label
Figure 8 - Instrument label
Legend of the information contained on the label:
1. Information about the manufacturer
2. Name and code of the instrument
3. Certification of Conformity to the CE legislation for the European Union
4. Mark of declaration that the instrument is to be used for in vitro diagnosis only
5. Declaration of the power requirements for the US, Canada and Europe
6. Specification of the maximum power consumed and the characteristics of the
protection fuses at the input of the instrument
1
234
5
6
7

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7. Serial number and production date