Diesse MINI-CUBE User manual

Rev 1.3 06/2018 1/59
USER MANUAL
Software Release No. 1.xx
Rev. 1.3 issued on June 2018
Automatic 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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This manual is applicable to the following MINI-CUBE instrument models:
Catalog Number
Description
10392
MINI-CUBE
MINI-CUBE 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)
21430320
Bluetooth MINI-CUBE Printer
10404
MINI-CUBE Thermal paper (for Bluetooth MINI-CUBE printer)
20550510
External barcode reader
30006190
MINI CUBE USB-to-Serial adapter
List of User Manual REVISIONS
REV. USER
MANUAL (00417)
DESCRIPTION OF CHANGES
0 of 01/06/2016
Initial revision
1 of 01/10/2016
Chapter 3 composition of the istrument
1.1 of 25/01/2017
Modification of the list of manuals revision and drafting of the
document software revisions
http://www.diesse.it/_files/files_prodotti/File/minicube/MINICUBE_Firmware_History.pdf
1.2 of 22/02/2018
Edit description “Test Device NEXT”
1.3 of 20/06/2018
Modify of controls

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Standards applied to this document:
-Directive 98/79/EC on in vitro diagnostic medical devices
-EN 61010-1 (CEI 66-5) “Safety requirements for electrical equipment for measurement,
control laboratory use –Part 1: General requirements”.
-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”
-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”.
-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”
-UNI EN ISO 18113-3 Information provided by the manufacturer (labeling) - Part 3: in vitro
diagnostic instruments for professional use
-UNI EN ISO 22870 Point of care testing (IOCT) –Requirements for quality and
competence
-Clinical and Laboratory Standards Institute, H02-A5, Procedures for the Erythrocyte
Sedimentation Rate Test; Approved Standard—Fifth Edition
The information contained in this manual may be subject to modifications without prior notice. 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.
Earth (ground) terminal
WEEE: Waste from Electrical and Electronic Equipment - Obligation of separate
waste collection according to L.D. 25/07/2005 no. 151 (Italy), implementation of
the directives 2002/96/EC and 2003/108/EC
Warning, read the manual, observe 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.
Important information.
BIOHAZARD: risk of contamination with potentially infected substances.
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
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
When an analysis system like the MINI-CUBE is used, 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 foreseen for the operator and
appropriate for the work environment. Comply with directives on safety and with
applicable laws.
In the case of leakage of biological material, during the working cycle, 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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CONTENTS
INTRODUCTION..........................................................................................................................9
PRESENTATION OF THE INSTRUMENT ......................................................................................................9
CLINICAL MEANING OF ESR ...............................................................................................................10
NORMAL ESR VALUES (WESTERGREN CITRATED)......................................................................................11
MATERIALS REQUIRED FOR USE OF THE INSTRUMENT .................................................................................12
MAINTENANCE PROCEDURE...............................................................................................................12
EXTERNAL CLEANING OF THE INSTRUMENT .............................................................................................13
TECHNICAL DATA....................................................................................................................14
TECHNICAL DESCRIPTION ..................................................................................................................14
EXTERNAL CONNECTIONS OF THE INSTRUMENT ........................................................................................15
TECHNICAL FEATURES ......................................................................................................................16
INSTALLATION .........................................................................................................................17
TRANSPORT AND HANDLING ..............................................................................................................17
PACKAGING CHARACTERISTICS ............................................................................................................17
MATERIALS PROVIDED .....................................................................................................................18
UNPACKING THE INSTRUMENT............................................................................................................19
SETUP........................................................................................................................................20
INSTALLATION PROCEDURE ................................................................................................................20
LIMITATIONS AND WARNINGS ............................................................................................................21
COMPOSITION OF THE INSTRUMENT.....................................................................................................21
DISPOSAL ....................................................................................................................................21
USE............................................................................................................................................22
COMPATIBLE TEST TUBES ..................................................................................................................22
PREPARATION OF THE SAMPLE............................................................................................................22
TEST TUBE LABELLING ......................................................................................................................23
DESCRIPTION OF THE MINI-CUBE MENU ..............................................................................................24
PERFORMING AN ANALYSIS .........................................................................................................25
INSERTING THE TEST TUBES................................................................................................................26
STARTING THE ANALYSIS CYCLE ...........................................................................................................27
ARCHIVE ...................................................................................................................................29
SETTINGS ..................................................................................................................................33
QUALITY CONTROL .................................................................................................................36
PERFORMING QC ANALYSIS ...............................................................................................................38
TROUBLESHOOTING ...............................................................................................................39
MEASURING ABNORMAL SAMPLES ......................................................................................................40
CALCULATING THE DAS 28 ....................................................................................................41
CLINICAL SIGNIFICANCE OF RHEUMATOID ARTHRITIS ...................................................................41
THE IMPORTANCE OF EARLY DIAGNOSIS......................................................................................41
DAS 28....................................................................................................................................44
CONNECTION TO A HOST COMPUTER ..................................................................................49
BIBLIOGRAPHY ........................................................................................................................58

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INTRODUCTION
Presentation of the instrument
he MINI-CUBE (Fig 1.0) is an automated instrument designed
to measure the erythrocyte sedimentation rate (ESR) of blood
samples anti-coagulatedwith EDTA, directlyfrom the EDTA
tube. The instrument analyzesfour blood samples
simultaneously on a random access and continual loading
basis. The color touch screen allows the user to select various instrument
functions which are described in more detail in the following sections. ESR
results, obtained in only 20 minutes, show excellent correlation to the
Westergren Reference method at one hour (ref. 1-10).
Fig. 1.0
Chapter
1
T

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The instrument is designed with the temperature correction always activated
and relates the results to a temperature of 18°C according to Manley’s
Nomogram (graph 1.0) (ref. 11). However, it is possible to de-select the
temperature correction for individual laboratory needs.
Graph 1.0 Manley’s Nomogram
Clinical meaning of ESR
The erythrocyte sedimentation rate measures the distance travelled by red
blood cells in autologous plasma for a certain period of time. In normal
conditions, red blood cells tend to reciprocally move apart due to the presence
of negative electric loads 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 hepatic level, following
an inflammatory process or tissue damage, the bond of these proteins
(fibrinogen, immunoglobulins) with the surface of the red blood cells, changes
the membrane potential negative load (Z) and the red blood cells can bind,
forming a rouleaux formation. These rouleauxed cells aggregate to form
microspheres of a uniform radius which sediment as their density exceeds that
of plasma. The ESR value increases in all conditions with increased acute
phase proteins, particularly fibrinogen which is considered to account for 70%

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of the sedimentation phenomenon, and increased immunoglobulins observed
with oncological/haematological diseases and acute infections. The ESR is
therefore a non-specific measurement of an inflammatory state; the rate is high
in numerous, different pathological conditions such as inflammatory diseases
(infections, rheumatic diseases), a relative/absolute increase in globulins
(nephrotic syndrome, myeloma), tissue necrosis (myocardial infarction,
tumours). Literature suggests the ESR is useful in diagnosing some diseases,
such as polymyalgia rheumatica, temporal arteritis, rheumatoid arthritis and
Hodgkin’s disease, and is useful as an effective marker of pharmacological
treatment in some diseases including rheumatoid arthritis, vasculitis,
collagenosis and septic arthritis. The ESR in usually higher in females
compared to males and increases in pregnancy and tends to rise with age in
both genders.
Normal ESR values (Westergren citrated)
With the Westergren reference method, the test is performed on blood diluted
in citrate; with four parts blood to one part anti-coagulant. The diluted blood is
then aspirated in a special, graduated, 2.5 mm diameter pipette which is kept
upright. The erythrocyte sedimentation level is recorded after one hour,
measuring the distance between the lower side of the plasma meniscus to the
top layer of 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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Materials required for use of the instrument
Exclusively use the materials of the MINI-CUBE line manufactured by DIESSE
DIAGNOSTICA SENESE S.p.A. (Always read the instructions for use that
accompany each product before operating); 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.
Precautions
The MINI-CUBE system offers a closed tube system which provides less
exposure to potentially infectious samples; however, all necessary precautions
and personal protective equipment for handling biological material apply.
Waste material should be disposed of in accordance with your local waste
requirements.
Maintenance procedure
The MINI-CUBE is designed to require minimal maintenance.
For any type of maintenance activity:
-Switch-off the instrument and disconnect from the power source.
-Use all appropriate personal protective equipment during operation.
In the event of biological material leakage,wipe the outer surfaces of the
instrument with 70% isopropyl alcohol and immediately contact Technical
Services

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External cleaning of the instrument
External cleaning is required for safety reasons.
1. With the instrument turned off, clean with liquid detergent and leave to
dry.
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 any other operation on the instrument.
Do not attempt to remove any of the screws or open the instrument and/or
clean the interior. Pleasecontact Technical Services for further instruction.
DECONTAMINATION
PROCEDURE:

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TECHNICAL DATA
Technical description
Fig. 2.0
The MINI-CUBE module consists of a single body containing all the operating
functions necessary for analyzing the sample.
The motor lifts the reading unit which utilizes four optical sensors (one per
position) to verify the suitability of the sample and detect the level at
baseline and level after 20 minutes of sedimentation.
The optical sensor of each position scans the inserted test tube, checking
that it contains an adequate volume of blood and identifying the type of
tube (4 ml EDTA or 500 µl microtainer EDTA).
The function of the alarm is to alert the operator during various stages of
the operating cycle or in the event of errors.
Chapter
2
Reading unit
Detection of the
sample
Alarm

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The sample is identified by an external bar code reader (optional accessory).
The patient ID code can also be manually entered using a stylus on the keypad
display.
External connections of the instrument
The MINI-CUBE has a Bluetooth 4.0 connection for an external printer (optional
accessory) or for connection to amobile device.
The power supply, serial/USB port for connection to the computer, a USB port
for connection to the USB mass storage device (B) that can be used to update
software or export files) and port for the external bar code reader are positioned
at the rear. The functional units of the module are described below.
Fig 2.1
Identification of
the sample
(A) USB cable
(B) USB stick

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Technical features
USE
Internal use
POWER SUPPLY
Input: 100-240 Vac, 50-60Hz, 0.5A
Output: 9Vdc@2A marked UL
LPS, DC output shall be provided a reinforced
insulation between primary and secondary circuits
DIMENSIONS
(mm)
135x191x125
WEIGHT
1.5 kg (3.31 lbs)
ROOM
TEMPERATURE
Operating temperature From +5° to +40°C
Storage temperature From +5° to +45°C
RELATIVE
HUMIDITY (RH)
20%-80% without condensation
ALTITUDE
Maximum 2000 meters (6562 ft)
NOISE LEVEL
below 80 decibel
LEVEL OF
POLLUTION
2 pollution degrees
MEASUREMENT
RANGE
from 0 to >140 mm/hr
for paediatric tubes from 0 to >60 m/hr
CENTRAL UNIT
ARM Cortex-M4 180 MHz Microprocessor
DISPLAY
480x272 TFT 16.7 Million colors+ Resistive Touch
Panel
OPTICAL UNIT
4 pairs of optical elements (photodiode +
phototransistor)
INTERFACES
USB
CLASS OF
DEVICE
III
SAFETY
STANDARDS
CEI EN 61010-1; CAN/CSA-C22.2 No. 61010-1-12;
ANS/UL 61010-1-2012
EMC
CEI EN61326
INSTALLATION
CATEGORY
II
Unit of measure
The units of measure are expressed according to the INTERNATIONAL
MEASURING SYSTEM as indicated in the technical standard as indicated in
the technical standard CEI EN ISO 80000-1:2013.

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INSTALLATION
The MINI-CUBE is a precision instrument and must be handled with appropriate
care and precautions. Inappropriate operations may damage the internal
optoelectronic components and cause mechanical damage. Follow the
instructions in this chapter in order to guarantee the operation of the instrument
and safety of the operator.
Transport and handling
The instrument must be transported and handled in its original packaging. Do not
leave the packed instrument in a damp environment or allow the boxed package
to get wet. If the instrument has been subjected to temperature conditions below
10°C for more than 24 hours, allow the instrument to sit at room temperature for
one hour prior to installing/powering on.
Packaging characteristics
The instrument is packed in:
1. an external cardboard box
2. moulded housing in CFC and HCFC-free expanded, closed cell
polyethylene.
Box Dimensions
33 x 23 x 15
cm
1.5
Kg
Chapter
3
Save the original
packaging
including the
internal parts.

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Materials provided
The MINI-CUBE is supplied with the following materials:
User Manual.
USB mass storage with multi-lingual manual.
Non-capacitive touch stylus.
DC power Supply (see characteristics in Technical Features section).
One power cable for each module according to IEC International
Standards (Female Plug IEC 320 C-13; Male Plug Schuko EEC 7-VII;
Rating: 10A / 250V AC).
USB cable.
Certificate of Analysis.
Packing list.
Fig.3.0

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Unpacking the instrument
1. Open the box from the top (see the packing labels) and remove the
accessories
Fig.3.1
2. Remove the instrument and power supply unit from the box
3. Remove the expanded polyethylene blocks containing the instrument
and power supply unit
Fig. 3.2
4. Remove the protective pack from the instrument
5. Verify the materials supplied against the packing list

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Setup
For normal safety requirements and given the type of examination it performs, the
instrument must be positioned away from heat sources, in areas unreachable by
liquids and in a dust-free environment. Position the instrument on a solid perfectly
level bench, not subject to shaking or vibrations. The 15 cm or 6” perimeter
distance as indicated in the figure 3.3 must be observed as a safety precaution.
It is advisable to position the instrument to 1 meter from devices that
generate electromagnetic waves (e.g. laboratory fridges, centrifuges) and
instruments that do not have CE marking.
The safety of the instrument and of the operator is not guaranteed if one or more
of the following conditions are violated.
-The mains must be compatible with the voltage and current
specifications indicated on the metal plate affixed below the
instrument.
-Before connecting external accessories (BC reader, printer, USB
sticks), check the compatibility.
Installation procedure
Only use the power supply unit provided
1. Position the instrument on a solid surface, as described above.
2. After checking that the power switch is in the “OFF” position, connect the
power supplyunit plug provided with the instrument.
3. Connect the power supply unit cable to the mains.
4. Optional - connect the barcode scanner and Bluetooth printer. Once the
MINI-CUBE is powered on, a series of beeps will be heard indicating that
Fig.3.3