Diesse MINI-CUBE User manual

SERVICE MANUAL
Rev. 1.2 –December 2021
Automatic instrument for ESR determination
with modified Westergren method
Software version 1.xx
FOR IN VITRO DIAGNOSTIC USE ONLY

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MINI-CUBE models:
This manual applies to the following MINI CUBE model:
Catalog number
Description
10392
MINI CUBE
MINI-CUBE Accessories:
Catalog number
Description
10435
ESR CONTROL CUBE 4 x 9 ml (2 x Level I + 2 x Level II)
10436
ESR CONTROL CUBE 2 x 9 ml (1 x Level I + 1 x Level II)
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
Manual revisions list:
MANUAL revisions
Description of changes
1.0 of 30.09.2016
First issue
1.1 of 23.04.2021
Updated manual with new manual layout and new logo.
Replaced MINI-CUBE figures due to new graphic design with
updated brand colors.
1.2 of 13.12.2021
Manual update following the latest FW release (V. 1.26) and new
set of service parameters.
Update of the screen with the new heading.
Adding of Chapter 1.6 “Preventive Maintenance”and of Chapter 5
“Exploded views of the instrument”

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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: [e-mail]
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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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, Procedures for the Erythrocyte
Sedimentation Rate Test; Approved Standard—Fifth Edition

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Symbols:
Key of graphic symbols
Instrument meeting the requirements of the European Directive
98/79/EC on in vitro diagnostic medical devices (98/79/CE).
In vitro diagnostic medical device
Manufacturing date
Serial number
Manufacturer
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.
Instrument that complies with MET standards for the Canadian and
US markets

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LIMITATIONS AND WARNINGS
Revision 1.2 of this manual corresponds to the MINI-CUBE model of the instrument with
the 1.x.x family of installed software.
It was drafted and carefully reviewed and this version is closely related to the instrument
model (data can be obtained from the instrument’s ID plate) and the version of the
software that controls it (data can be obtained through a procedure on the instrument
itself).
It must be read carefully before using the instrument, especially the parts relating to
safety.
ATTENTION
Do not use this manual except in its complete form.
If this manual is used in an incomplete form, DIESSE Diagnostica Senese S.p.A.
declines any responsibility for adverse results.
ATTENTION
Any instrument updating done with the customer’s authorization requires that
the user manual be updated in a corresponding manner.
DIESSE Diagnostica Senese SpA accepts no responsibility for damage caused directly or
indirectly by errors, defects, or incidents due to any use of this manual that does not
correspond with the version of the supplied instrument.

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Content
1GENERAL DESCRIPTION OF THE INSTRUMENT ................................................................................9
1.1 Overall view of the unit ..................................................................................................................................9
1.2 Updating software......................................................................................................................................10
1.3 Technical specifications........................................................................................................................... 11
1.4 Content and package dimensions.................................................................................................... 11
1.5 Shutting down and shipping .............................................................................................................. 12
1.6 Preventive Maintenance ........................................................................................................................14
2DISASSEMBLY PROCEDURE (AND REASSEMBLY) ............................................................................ 15
2.1 Preliminary tasks assigned to the technical service............................................................. 15
2.2 Equipment / instrumentation required........................................................................................ 15
2.3 Disassembly and reassembly procedures................................................................................... 15
3SERVICE MENU...................................................................................................................................................... 21
3.1 Service functions ......................................................................................................................................... 21
3.1.1 Access to the service menu................................................................................. 21
3.1.2 Service menu........................................................................................................ 23
3.1.3 Diagnostics functions .......................................................................................... 26
3.1.4 Reading parameters......................................................................................... 34
3.1.5 Reading viewer..................................................................................................... 37
3.1.6 Special................................................................................................................... 42
4LEARNING ABOUT THE UNIT- DESCRIPTION OF THE MAIN MODULES .........................43
4.1 CPU board connections.........................................................................................................................43
4.1.1 Interconnection board......................................................................................... 44
5EXPLODED VIEWS OF THE INSTRUMENT ..........................................................................................45
6ATTACHMENT A: EXTERNAL CONNECTIONS .................................................................................... 52
6.1 General specifications for connecting to a barcode reader............................................ 52
7ATTACHMENT B: CONNECTION TO A HOST COMPUTER.......................................................... 53
8ATTACHMENT C: SPARE PARTS LIST ......................................................................................................60

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1GENERAL DESCRIPTION OF THE INSTRUMENT
1.1 Overall view of the unit
Figure 1
The MINI CUBE module consists of a single body containing all the operating functions
necessary for analyzing the sample. The instrument has 4 housings to insert the samples.
The motor lifts the reading unit that, with the help of four optical sensors (one per
position) verifies the suitability of the sample and detects the level at baseline and after
20 minutes of sedimentation.
The sample is detected when it is put into the test tube. 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: normal (13x75 mm EDTA tube) or pediatric (BD
Microtainer®, BD Microtainer® MAP, Greiner MiniCollect® or Sarstedt Microvette® APT
EDTA tubes).
The function of the beeper is to alert the operator during various stages of the operating
cycle or in the event of errors.

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The sample is identified by an external barcode reader (accessory). The patient ID code
can be manually entered from a virtual keyboard.
External connections of the instrument
The MINI CUBE has a Bluetooth 4.0 connection for an external printer (accessory) or for
connection to a mobile device (in particular, for connection to the APP).
The power supply, serial/USB port for connection to the computer, a USB port for
connection to the USB mass storage device (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.
Figure 2
1.2 Updating software
Updating software is a simple, direct procedure:
•Save the new software (i.e. mcfw.bin file and System folder) into a USB mass storage
device
•With the instrument switched off, insert the USB device into the appropriate port
Power on the instrument and wait for a few seconds. The instrument will update
automatically.

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1.3 Technical specifications
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 (6562ft)
NOISE LEVEL
below 80 decibel
LEVEL OF POLLUTION
2 pollution degrees
MEASUREMENT RANGE
4 ml Tube: 0 to >140 mm/hr
Pediatric Tube: 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
Safety requirements and functional performances of the instrument are not
assured if you use a different power supply from the one supplied in the package.
1.4 Content and package dimensions
The instrument is packed in:
1. An external cardboard box.
2. Molded housing in CFC and HCFC-free expanded, closed cell polyethylene.
The box has the following characteristics
Dimensions
cm
33x23x15
Weight
Kg
1.5

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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 Specifications 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
Figure 3
Do not throw away the original packaging in case of further transportation of
the instrument in the future.
1.5 Shutting down and shipping
Before shutting down and shipping the instrument, it is recommended
carrying out the following sanitizing procedure:
A) The instrument must be turned off and cleaned internally of all residues or
spillage with a liquid detergent and left to dry.
B) Use one of the ready-to-use spray cans of isopropyl alcohol available on the market.
C) Spray well on the sample-holder.

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D) Leave turned off for at least one hour before beginning a new work cycle or any
other type of operation on the instrument.
Instrument may be damaged if dropped.
Shipping
1. Put the instrument into its plastics bag and place the two the expanded
polyethylene blocks to hold the instrument.
Figure 4
2. Place the Unit contained between the expanded polyethylene blocks and the power
supply into the box.

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Figure 5
If the instrument is being shipped to the manufacturer for repairs, affix a copy of the
“Fault Report” form (contained in this document) to the outside of the box.
1.6 Preventive Maintenance
a) Turn off the instrument.
b) Disconnect the instrument form the power supply in order to prevent risk of
contact with any energized electrical or mechanical parts.
c) Remove the rear plastics panel by unscrewing the four screws in the corners.
d) Clean the motor motion screw with WD40.
e) Lubricate the motor motion screw with CRC66-6.
f) Clean with compressed air the motor home sensor and the emitter and receiver
of the reading sensors unit.

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2DISASSEMBLY PROCEDURE (AND REASSEMBLY)
2.1 Preliminary tasks assigned to the technical service
Before any type of operation on the instrument:
a) TURN OFF THE ON/OFF SWITCH ON THE UNIT.
b) DISCONNECT THE INSTRUMENT FROM THE POWER SUPPLY IN
ORDER TO PREVENT RISK OF CONTACT WITH ANY ENERGISED
ELECTRICAL OR MECHANICAL PARTS.
FAILURE TO OBSERVE THESE INSTRUCTIONS SHALL RELEASE THE
MANUFACTURER OF THE MINI CUBE FROM ALL LIABILITY.
2.2 Equipment / instrumentation required
•Multimeter - Mod.Fluke 8010A or equivalent.
•Set of screwdrivers.
•Set socket-head spanners.
•5.5mm Plug socket spanner.
2.3 Disassembly and reassembly procedures
Disassembly procedure
a) Follow the instructions in paragraph 2.1 points a) and b).
b) Remove the rear plastics panel by unscrewing the four screws in the corners.
Figure 6

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c) To open the front panel, use a screwdriver from the rear side to unscrew the 4
screws anchoring the front panel to the main metal body:
Figure 8
Figure 7

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Figure 9
It is now possible to access the CPU Board and the cables can be disconnected to replace
it.
d) To Access to the Interconnection Board and the Transponder Antenna, remove
the plastics panel from the bottom side by unscrewing the 5 screws:
Figure 10

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Figure 11
e) Unscrew the two screws that fix the board and remove it to access to its
connectors and cables and to access the screw to remove the Base Block
Figure 12
f) To remove the base block unscrew the 4 screws visible below:

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Figure 13
g) Once the Base Block has been removed, it is possible to remove the Motor +
Motion Screw assembly; unscrew the two screws that fix the motor and then
manually rotate the Motion screw to release it from the Reading Sensors
Block
h) Removing the Reading Sensors Unit is now possible, without removing the
Motor, by removing the 4 Sample Tubes Holders. To remove them, access
from the bottom of the metal block to release the screws (do not unscrew
them completely) that fix the Sample Holders. At this point, pull-up the
bottom part out from its site to free it, then make it pass through the upper
round hole on the metal block.
Figure 14

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i) Once the holders have been removed, it is possible to take out the Reading
Sensors Unit. Then, by unscrewing the 4 small screws, it will be released from
the carriage that moves along the Moving Screw:
Figure 15
j) To be able to completely remove the Reading Sensors Unit out of the Instrument,
disconnect the flexible cables from the CPU board
Reassembly procedure
Follow the steps of the disassembly procedure in reverse.
During this phase, make sure to prevent the wires from becoming entangled
in the mechanical parts.