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RPT-10688-00-F

I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 1 / 10
Technical Report

MIURA
_____________________________

Export of Analysis Results

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 2 / 10
Technical Report

Document Identification

Revision: Rev. F
Code: RPT-10688-01-F
Date: 26/04/2010
File Id.: RPT-10688-01-F, MIURA – Results Exporting.doc
Classification: Confidential

Modifications

Rev. Date Description


A 18/10/2006 Emission of document
B 14/12/2006 New fields added
C 25/01/2007 New paragraph added
D 30/04/2008 New fields in MethodList exported file
E 16/09/2008 New field (Date) in exported results
F 26/04/2010 New paragraph (std export)
G

Author and Authorizations

Name Date Signature


Author C. Ruggeri

R&D G. Grifoni

Direction D. Spadaccioli

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Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 3 / 10
Technical Report

Abbreviation and Acronym List

AD Applicable Document
CQ Quality Control
CV Coefficient of Variation
FW Firmware
HW Hardware
OD Optical Density (Absorbance)
SD Standard Deviation
SW Software
TBC To Be Confirmed
TBD To Be Defined
TBV To Be Verified

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 4 / 10
Technical Report

List of Contents
List of Contents................................................................................................................................................4
1. Purpose....................................................................................................................................................5
2. Documentation......................................................................................................................................5
2.1. Applicable Documents................................................................................................................5
2.2. Reference Documents.................................................................................................................5
3. General Description ..............................................................................................................................6
4. Miura Program Root Folder ..................................................................................................................7
5. Location and Format of the Results Export File .................................................................................7
6. Location and Format of the Method Export File...............................................................................8
7. Location and Format of the Quality Control Export File..................................................................9
8. Location and Format of the Standard Export File ..........................................................................10

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 5 / 10
Technical Report

1. Purpose
This document defines format and location of the file listing the analysis session results. It is
generated on request by the MIURA Clinical Chemistry Autoanalyzer and it is useful for the lab
informatic system engineers.

2. Documentation

2.1. Applicable Documents


Not applicable.

2.2. Reference Documents


The following documents must be considered as applicable:
AD1 - MNU-10563-xx-x MIURA – User Manual, last revision
AD2- MNU-10704-xx-x MIURA 200 – User Manual, last revision

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 6 / 10
Technical Report

3. General Description
The Miura User Interface gives the operator the possibility to export the results and the list of
methods into files.
The Results Menu (Result for Patient section) provides the “Export Concluded Samples” command
that automatically generates a file including the results of all concluded patient analysis of the
actual or last working session.
As well, the Memory Files Menu provides the “Export all” command, that allows exporting of the
results given by the sorted research.

Moreover, the system generates automatically a file listing all of the methods stored, any time that
the operator saves or deletes a method. This file over-writes the former one.

These files are exported into special folders for user handling; they can be copied on a media or
accessed by an host computer when the MIURA managing PC has been connected into a LAN.
In case that the MIURA PC has been included into a LAN, the “ExportedResults” folder must be
“shared” in network in order to allow an host computer to download and treat the file itself.

The exported files are *.csv type.

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 7 / 10
Technical Report

4. Miura Program Root Folder


ProgramRoot = %ROOT% \Program Files\Miura

5. Location and Format of the Results Export File


This file includes the working session concluded results and is created for each export operation
and do not over-write the old one.
Its name allows the identification by the actual date and time. The exported file is a *.csv type (with
the semicolon “;” as values separator).
The export file is composed by a series of records, one for each analysis concluded.

Location of the file:


%ProgramRoot% \ExportedResults
File name:
exp_YYYY_MM_DD_hh_mm.csv
(i.e.: exp_2006_10_17_17_23.csv)
File Structure Format:
Record delimiter character: ascii code 10 (Line Feed)
Record Field delimiter: ascii code 59 (‘;’)

Record fields:
Patient Patient Patient Id Method Method Index Result Unit of Minimum Maximum Date
Last Name Code Internal Acronym repeat Measure- Reference Reference
Name Index* ment Value Value
* See Method export file format

Fields meaning:
• Patient Last name: patient family name
• Patient Name: patient first name
• Patient Identification Code: work list identification code of patient
• Method Internal Index: identification code of the analysis method. A list of the methods
linked to the proper identification code is included in the file
methods.csv; it is generated automatically and over-written by
the instrument every time that a method has been saved (SAVE
command in Methods Menu).
• Method Acronym: acronym given to the analysis method.
• Repetition Index: 0 based index to identify multiple execution of same analisys
• Result: result of the analysis
• Unit of measurement: unit of measurement of the result
• Minimum Rreference Value: minimum normal value
• Maximum Reference value: maximum normal value.
• Date: date of execution

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 8 / 10
Technical Report

6. Location and Format of the Method Export File


This file gives the association between methods and their Id Code. This file is created every time a
method is saved and over-writes the last one.

Location:
%ProgramRoot% \ MethodList
File name:
methods.csv
File Structure Format:
Record delimiter character: ascii code 10 (Line Feed)
Record Field delimiter: ascii code 59 (‘;’)

Record fields:
Method Name Method Acronym Method barcode Method Internal
Index

Fields meaning:
• Method Name: name given to the analysis method
• Method Acronym: acronym given to the analysis method.
• Method Barcode Unique barcode for method
• Method Internal Index: identification code of the analysis method.

Note: the field Barcode could be empty.

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 9 / 10
Technical Report

7. Location and Format of the Quality Control Export File


This file includes the concluded quality control results stored in “memory files”, it is created for each
export operation and it doesn’t over-write the old one.
Its name allows the identification by the actual date and time. The exported file is a *.csv type (with
the semicolon “;” as values separator).
The export file is composed by a series of records, one for each analysis concluded.

Location of the file:


%ProgramRoot% \ExportedResults
File name:
expQC_YYYY_MM_DD_hh_mm.csv
(i.e.: expQC_2006_10_17_17_23.csv)
File Structure Format:
Record delimiter character: ascii code 10 (Line Feed)
Record Field delimiter: ascii code 59 (‘;’)

Record fields:
Method Method QC QC Reagent Result Unit of Minimum Theoretical Maximum Date
Internal Acronym Identifier lot lot Measu- Referen- Reference Reference
Index * rement ce Value Value Value
* See Method export file format

Fields meaning:
• Method Internal Index: identification code of the analysis method. A list of the methods linked
to the proper identification code is included in the file methods.csv; it is
generated automatically and over-written by the instrument every time
that a method has been saved (SAVE command in Methods Menu).
• Method Acronym: acronym given to the analysis method.
• QC Identifier: identify if control C1, C2 or C3.
• QC lot: lot number of the QC serum.
• Reagent lot: lot number of the method.
• Result: result of the control.
• Unit of measurement: unit of measurement of the result.
• Minimum Reference minimum normal value of the control.
Value:
• Theoretical Reference theoretical value of the control.
Value:
• Maximum Reference maximum normal value of the control.
value:
• Date: date of the analysis; format YYYY_MM_DD_hh_mm
where
YYYY, year
MM, month
DD, day
hh, hour
mm, minute.

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.
RPT-10688-00-F
I.S.E. S.r.l.
Via delle Driadi, 45 – 00133 Roma Rev. F of 26/04/10

pag. 10 / 10
Technical Report

8. Location and Format of the Standard Export File


This file includes the concluded calibration results stored in “memory files”, it is created for each
export operation and it doesn’t over-write the old one.
Its name allows the identification by the actual date and time. The exported file is a *.csv type (with
the semicolon “;” as values separator).
The export file is composed by a series of records, one for each calibration record. The record has
a fixed length and the number of the standard [Std nr] determines how many valid fields are
included in the record itself.

Location of the file:


%ProgramRoot% \ExportedResults
File name:
expStd_YYYY_MM_DD_hh_mm.csv
(i.e.: expQC_2006_10_17_17_23.csv)
File Structure Format:
Record delimiter character: ascii code 10 (Line Feed)
Record Field delimiter: ascii code 59 (‘;’)

Record fields:
Method Method Cal Std lot Std lot Std nr Factor Std Conc. Std Value Std Od Std Od Cal
Internal Acronym Unique Exp Ratio x x blank x Date
Index * id date x
Repeated n times (n=nr. of standardsÆ”Std nr”)
* See Method export file format

Fields meaning:
• Method Internal Index: identification code of the analysis method. A list of the methods linked
to the proper identification code is included in the file methods.csv; it is
generated automatically and over-written by the instrument every time
that a method has been saved (SAVE command in Methods Menu).
• Method Acronym: acronym given to the analysis method.
• Cal unique id: Unique identifier of calibration record
• QC lot: lot number of the std serum.
• Std lot exp date: Std lot expiration date
• Std nr: number of the standards of current record.
• Factor: Factor
• Std conc ratio x: Concentration ratio of the point “x” of the standard (with x=1-8)*
• Std value x: Std value of the point “x” of the standard (with x=1-8)*
• Std od x: Std optical density of the point “x” of the standard (with x=1-8)*
• Std od blank x: Std blank optical density of the point “x” of the standard (with x=1-8)*
• Cal Date: date of the record; format YYYY_MM_DD_hh_mm
where
YYYY, year
MM, month
DD, day
hh, hour
mm, minute.
* notes: if x=1 Æ mono-standard
if 2≤x≤8 Æ multi-standard (calibration curve)

This document is property of I.S.E. s.r.l.


Unauthorized copies or alterations of its contents could cause legal actions in order
to preserve owner’s interests.

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