Diesse MINI-CUBE Bedienungsanleitung

USER MANUAL

Rev. 1.7 –May 2022

Automatic instrument for ESR determination

with modified Westergren method

Software version 1.xx

FOR IN VITRO DIAGNOSTIC USE ONLY

Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 2

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Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 3

MINI-CUBE models:

This manual is applicable to the following MINI-CUBE instrument models:

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)

21430440

Bluetooth Printer

10404

MINI-CUBE Thermal paper (for Bluetooth printer)

20550510

External barcode reader

30006190

MINI CUBE USB-to-Serial adapter

Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 4

Manual revisions list:

MANUAL revisions

Description of changes

0 - 01/06/2016

Initial revision

1 - 01/10/2016

Chapter 3 composition of the instrument

1.1 - 25/01/2017

Modification of the list of manuals revision and drafting of the

document software revisions

1.2 - 22/02/2018

Edit description “Test Device NEXT”

1.3 - 20/06/2018

Modify of controls

1.4 - 31/07/2020

Addition of Intended Use, Updating Software and BD Microtainer®

MAP tubes paragraphs, update of WEEE and RAE normative

references, inserted QR code for connecting to host instructions

1.5 - 17/05/2021

Update of the manual with new logo and new graphic design with

updated brand colors

1.6 - 17/08/2021

Update of the manual following the latest FW release (V. 1.26).

Update of the screen with the new heading.

Adding of APPENDIX MINI-CUBE PRINTER TOOL II –MPT II

INSTALLATION GUIDE

1.7 –05/2022

Update of the intended purpose

Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 5

Manufacturer

DIESSE DIAGNOSTICA SENESE SpA

Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy

Tel. +39 0577 307109, Fax. + 39 0577 307106

www.diesse.it

TECHNICAL SUPPORT

Strada dei Laghi 39, 53035 Monteriggioni (SI) Italy

Tel. +39 0577 307109, Fax. + 39 0577 307106

Numero Verde: 800 606932

e-mail: technicalsupport@diesse.it

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.

Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 6

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

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

Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 7

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.

 
Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 8 
Content 
1INTRODUCTION..............................................................................................................................................................10 
1 Intended purpose............................................................................................................................................10 
2 Presentation of the instrument.........................................................................................................10 
3 Clinical significance of ESR.................................................................................................................... 11 
4 Normal ESR values (Westergren citrated).................................................................................. 12 
5 Materials required for use of the instrument............................................................................ 12 
6 Precautions..................................................................................................................................................... 12 
7 Maintenance procedure......................................................................................................................... 13 
8 External cleaning of the instrument............................................................................................... 13 
2TECHNICAL DATA..........................................................................................................................................................14 
1 Technical description ...............................................................................................................................14 
2 External connections of the instrument...................................................................................... 15 
3 Updating software...................................................................................................................................... 15 
4 Technical features.......................................................................................................................................16 
5 Unit of measure............................................................................................................................................16 
3INSTALLATION.................................................................................................................................................................17 
1 Transport and handling .......................................................................................................................... 17 
2 Packaging characteristics ..................................................................................................................... 17 
3 Materials provided...................................................................................................................................... 17 
4 Unpacking the instrument...................................................................................................................18 
5 Setup...................................................................................................................................................................19 
6 Installation procedure.............................................................................................................................20 
7 Limitations and warnings.....................................................................................................................20 
8 Composition of the instrument........................................................................................................20 
9 Disposal............................................................................................................................................................. 21 
4USE.........................................................................................................................................................................................22 
1 Instructions for the operator............................................................................................................... 22 
2 Compatible test tubes ............................................................................................................................ 22 

 
 
 
 Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 9 
3 Sample requirements ............................................................................................................................. 22 
4 Preparation of the sample ................................................................................................................... 22 
5 Test tube labelling..................................................................................................................................... 22 
6 MAP test tube labeling........................................................................................................................... 23 
7Description of the MINI-CUBE menu............................................................................................24 
7.1 Home........................................................................................................................................................24 
7.2 Performing an analysis..................................................................................................................24 
7.3 Inserting the test tubes.................................................................................................................26 
7.4 Starting the analysis cycle...........................................................................................................28 
7.5 Archive.....................................................................................................................................................29 
7.6 Settings ...................................................................................................................................................34 
5QUALITY CONTROL.....................................................................................................................................................37 
1 Performing QC analysis .........................................................................................................................40 
6TROUBLESHOOTING...................................................................................................................................................41 
1 Measuring abnormal samples...........................................................................................................43 
7CALCULATING THE DAS 28...................................................................................................................................44 
1 Clinical significance of Rheumatoid Arthritis...........................................................................44 
2 The importance of early diagnosis..................................................................................................44 
3 Das 28................................................................................................................................................................46 
8CONNECTION TO A HOST COMPUTER...........................................................................................................51 
9APPENDIX: MINI-CUBE PRINTER TOOL II –MPT II INSTALLATION GUIDE.............................53 
BIBLIOGRAPHY..............................................................................................................................................................54 
 
 
 

Rev. 1.7 (05.2022) MINI-CUBE | USER MANUAL 10

1INTRODUCTION

1.1 Intended purpose

The MINI-CUBE is an automated instrument for the quantitative Erythrocyte

Sedimentation Rate (ESR) determination, measured using modified Westergren

method on venous and capillary 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 MINI-CUBE (Figure 1.1) is an automated instrument designed to measure the

erythrocyte sedimentation rate (ESR) of blood samples anti-coagulated with EDTA,

directly from the EDTA tube. 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. 1.4).

Figure 1.1

The instrument is designed with the temperature correction always activated and

relates the results to a temperature of 18°C according to Manley’s Normogram (Figure

1.2). However, it is possible to de-select the temperature correction for individual

laboratory needs.

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