Diesse MINI-CUBE User manual

Rev 1.8 07/2020 1/50
USER MANUAL
Software Release No. 1.xx and 1.xx.xx
Rev. 1.8 issued in July 2020
Automatic instrument for ESR determination
with modified Westergren method
Only for in vitro diagnostic use
Rx Only

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This manual is applicable to the following MINI-CUBE instrument models:
Catalog Number
Description
10392
MINI-CUBE (Streck reference number 240401)
Accessories:
Catalog Number
Description
10293
TEST DEVICE NEXT 500 (500 tests)
(Streck reference number 240403)
10294
TEST DEVICE NEXT 1K (1000 tests)
(Streck reference number 240404)
21430320
Bluetooth MINI-CUBE printer (Streck reference number 240402)
20550510
External barcode reader (Streck reference number 240405)
LIST OF MANUAL REVISIONS
REV. USER
MANUAL
(00418)
DESCRIPTION OF CHANGES
0 of
01/06/2016
Original
1 of
01/10/2016
Chapter 3 composition of the instrument
1.1 of
25/01/2017
Modification of the list of manual revisions and drafting of the document software
revisions available at:
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
14/01/2019
Addition of Rx symbol; insertion of Intended Use and Performances sections
1.4 of
18/02/2019
“Capillary blood” phrasing removed from Intended Use, added “semiquantitative”
in Intended Use
1.5 of
19/02/2019
Corrected an error in Intended Use section
1.6 of
31/01/2020
Addition of management of pediatric tubes called Microtainer ® MAP
1.7 of
25/05/2020
Addition of performance data for Microtainer ® MAP tubes
1.8 of
31/07/2020
Revision of the Procedure and performances for BD Microtainer® MAP tubes,
update of WEEE and RAE normative references

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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 ENISO22870 “Point of care testing (IOCT) –Requirementsfor qualityand competence
-Clinical and Laboratory Standards Institute, H02, Procedures for the Erythrocyte
Sedimentation Rate Test; Approved Standard”
The information contained in this manual may be subject to modifications without prior notice. No page
in thismanual maybe reproduced in any form or byany means, electronic, mechanical or otherwise, for
anyuse whatsoever without prior written permission from DIESSE DIAGNOSTICA SENESE S.p.A.

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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
LEGAL REPRESENTATIVE
CHAIRMAN OF THE BOARD OF DIRECTORS
Loic Kubitza
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:
Streck, Inc.
Technical Services 800.843.0912 x7510 or
[email protected]

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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 2012/19/EU Directive
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: potentialrisk of damage to the instrument; all the conditionsindicated
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. Contact Technical Services at 800.843.0912 or
technicalservi[email protected] for further instruction and assistance.
All supplied materials must be disposed of in accordance with local laws.

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CONTENTS
INTENDED USE.............................................................................................................................................. 8
INTRODUCTION............................................................................................................................................. 8
PRESENTATION OF THE INSTRUMENT......................................................................................................................... 8
CLINICAL SIGNIFICANCE OF ESR............................................................................................................................. 10
ESR REFERENCE VALUES (WESTERGREN CITRATED)..................................................................................................... 10
MATERIALS REQUIRED FOR USE OF THE INSTRUMENT.................................................................................................... 11
PRECAUTIONS .................................................................................................................................................. 11
MAINTENANCE PROCEDURE ................................................................................................................................. 12
EXTERNAL CLEANING OF THE INSTRUMENT ................................................................................................................ 12
TECHNICAL DATA....................................................................................................................................... 13
TECHNICAL DESCRIPTION ..................................................................................................................................... 13
EXTERNAL CONNECTIONS OF THE INSTRUMENT ........................................................................................................... 14
UPDATING SOFTWARE ........................................................................................................................................ 14
TECHNICAL FEATURES......................................................................................................................................... 15
UNIT OF MEASURE ............................................................................................................................................ 15
INSTALLATION ............................................................................................................................................ 16
TRANSPORT AND HANDLING ................................................................................................................................. 16
PACKAGING CHARACTERISTICS............................................................................................................................... 16
MATERIALS PROVIDED ........................................................................................................................................ 17
UNPACKING THE INSTRUMENT .............................................................................................................................. 18
SETUP ........................................................................................................................................................... 19
INSTALLATION PROCEDURE................................................................................................................................... 20
LIMITATIONS AND WARNINGS............................................................................................................................... 20
COMPOSITION OF THE INSTRUMENT........................................................................................................................ 20
DISPOSAL ....................................................................................................................................................... 20
USE ...............................................................................................................................................................21
INSTRUCTIONS FOR THE OPERATOR ......................................................................................................................... 21
COMPATIBLE TEST TUBES..................................................................................................................................... 21
SAMPLE REQUIREMENTS ..................................................................................................................................... 21
PREPARATION OF THE SAMPLE .............................................................................................................................. 21
TEST TUBE LABELING .......................................................................................................................................... 22
MAP TEST TUBE LABELING .................................................................................................................................. 22
DESCRIPTION OF THE MINI-CUBE MENU ................................................................................................................ 23
HOME.......................................................................................................................................................... 23
PERFORMING AN ANALYSIS ........................................................................................................................... 24
INSERTING THE TEST TUBES .................................................................................................................................. 25
STARTING THE ANALYSIS CYCLE .............................................................................................................................. 27
ARCHIVE ...................................................................................................................................................... 29
SETTINGS ..................................................................................................................................................... 33
QUALITY CONTROL....................................................................................................................................36
PERFORMING QC ANALYSIS.................................................................................................................................. 38
TROUBLESHOOTING..................................................................................................................................39
MEASURING ABNORMAL SAMPLES......................................................................................................................... 40
CONNECTION TO A HOST COMPUTER....................................................................................................41
PERFORMANCES........................................................................................................................................ 43
MINI-CUBE PRECISION ..................................................................................................................................... 43
MINI-CUBE CORRELATION ................................................................................................................................. 46
BIBLIOGRAPHY........................................................................................................................................... 48

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INTENDED USE
he MINI-CUBE is an automated instrument for the Erythrocyte
Sedimentation Rate (ESR) determination with the modified
Westergren method using venous and capillary whole blood
anticoagulated with K2EDTA or K3EDTA.
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-coagulatedwithEDTA,directlyfrom theEDTAtube.
The instrument analyzes four 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).
Chapter
1
T
T

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Fig. 1.0
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).
Graph 1.0 Manley’s Nomogram

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Clinical Significance 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
loadsfromthenumerousresiduesofsialicacidpresentatamembraneglycoprotein
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
aggregatetoformmicrospheresofauniformradiuswhichsedimentastheirdensity
exceeds that of plasma. The ESR value increases in all conditions with increased
acutephaseproteins,particularlyfibrinogenwhichisconsideredtoaccountfor70%
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),arelative/absoluteincreaseinglobulins(nephroticsyndrome,
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
rheumatoidarthritis,vasculitis, collagenosis,andsepticarthritis.TheESRinusually
higher in females compared tomales and increases in pregnancy and tends to rise
with age in both genders.
ESR Reference 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 plasma meniscus to the top layer of
sedimented red blood cells.

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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.
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
accompanyeachproductbeforeoperating);anyotherpartoraccessoryusedinthe
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 inaccordance with your local waste requirements.

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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.
Inthe eventofbiologicalmaterialleakage,wipethe outersurfacesoftheinstrument
with 70% isopropyl alcohol and immediately contact Technical Services at
800.843.0912 or [e-mail] for further instruction.
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 performing any other operation on the instrument.
Do not attempt to remove any of the screws or open the instrument and/or clean
the interior. Please contact Technical Services at 800.843.0912 or
[e-mail] 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 sample 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 (13x75
mm EDTA tube, BD Microtainer® or BD Microtainer® MAP EDTA tubes).
The function of the alarm is to alert the operator during various stages of the
operating cycle or in the event of errors.
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.
Chapter
2
Reading unit
Detection of the
sample
Alarm
Identification of
the sample

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External connections of the instrument
The MINI-CUBE has a Bluetooth 4.0 connection for an external printer (optional
accessory).
The power supply, serial/USB ports for connection to a computer (A), a USB port
for connection to the USB mass storage device (B) that can be used to update
software or export files and a port for the external bar codereader arepositioned at
the rear of the instrument. The functional units of the module are described below.
Fig 2.1
Updating software
Updating software is a simple, direct procedure:
-Save the new software into a USB mass storage device
-Withthe instrument switched off, insert the USBdevice into the appropriate
port (Fig. 2.2)
Power on the instrument and wait for a few seconds. The instrument will update
automatically.
Software revisions history is available on DIESSE’s website:
https://www.diesse.it/en/download/id:21651/
(A) USB cable
(B) USB stick
Fig. 2.2

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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)
135 x 191 x 125
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 decibels
LEVEL OF POLLUTION
2 pollution degrees
MEASUREMENT
RANGE
4 ml Tube: 0 to >140 mm/hr
Pediatric Tube: 0 to >100 mm/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
I
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 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
optoelectroniccomponents andcause mechanicaldamage. Follow the instructions
in this chapter in order to ensure proper 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 allowthe boxed package to
getwet.If theinstrumenthasbeensubjectedtotemperatureconditionsbelow10°C
formorethan24hours, allowthe instrumenttositat roomtemperatureforone hour
prior to installing/powering on.
Packaging characteristics
The instrument is packed in:
1. an external cardboard box
2. molded housing in CFC and HCFC-free expanded, closed cell
polyethylene.
Chapter
3
Save the original
packaging
including the
internal parts.
33 x 23 x 15
cm
1.5
Kg
Box Dimensions

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Materials provided
The MINI-CUBE is supplied with thefollowing materials:
User Manual
USB mass storage with multi-lingual manual
Non-capacitive touch stylus
DC power Supply (see characteristics in Technical Features section)
OnepowercableforeachmoduleaccordingtoIECInternationalStandards
(Female Plug IEC 320 C-13; Male Plug Schuko EEC 7-VII; Rating: 10A /
250V AC)
USB cable
Fig. 3.0

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Unpacking the instrument
1. Open the box from the top and remove the User Manual, Quick
Reference Guide and accessories.
Fig. 3.1
2. Remove the instrument and power supply unit fromthe 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

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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
levelbench,notsubjecttoshakingorvibrations.The15cmor 6” perimeterdistance
as indicated in figure 3.3must be observed as a safety precaution.
It is advisable to position the instrument to 1 meter away 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 operator is not guaranteed if one or more of the
following conditions are violated.
-The main power source must be compatible with the voltage and
current specifications indicated on the back of the instrument.
-Contact Streck Technical Services for compatibility prior to
attempting to connect any non-Diesse external accessories (i.e.
barcode reader, printer, USB drive).
Fig. 3.3

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Installation procedure
Only use the power supply unit provided
1. Position the instrument on a solid surface.
2. After checking that the power switch is in the “OFF” position, connect the
power supply unit plug provided with the instrument.
3. Connect the power supply unit cable to the main power source.
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
the system recognized the scanner. Follow the printer installation steps in
chapter 4 to enable the printer.
Limitations and Warnings
IN CASE OF FIRE OR GENERAL DANGER, TURN OFF THE INSTRUMENT AND
UNPLUG THE POWER CABLE.
Compositionof the instrument
The instrument is made up of the following materials, expressed in percentages:
Material in %
MINI-CUBE
IRON
10
COPPER
3
ALUMINIUM
60
PLASTIC MATERIALS (PVC, ABS...)
20
SILICON
2
Gold
0,1
Tantalum
0,2
Cadmium
0,2
Others (No Latex)
4,5
Disposal
The MINI-CUBE instrument relies on the use of an electrical power source and
therefore, in compliance with the European Directive 2012/19/EU and later
amendments by the European parliament, it is classified as Electrical-
Electronic Equipment. Disposal of the instrument at the end of its life cycle,
must be executed in accordance with local waste disposal regulations.