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Technical Report
MIURA
_____________________________
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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
R&D G. Grifoni
Direction D. Spadaccioli
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Technical Report
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
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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
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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
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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.
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Technical Report
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
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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.
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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.
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Technical Report
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)