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I.S.E.

– Sistemi Intelligenti Elettronici

Miura Instrumentation Series


Random Access Autoanalyzers

L.I.S. Connection – Technical Manual

I.S.E. S.r.l. – Italy Rome MNT-10910-01-B Rev.A ENG


MIURA Instrumentation Series
L.I.S. Connection – Technical Manual

i.1 Identification Data


This document applies to the MIURA Series instrument family, Random Access
direct reading automated laboratory analyzers for Clinical Chemistry.
Refer to the proper instrument User Manual for the detailed operation and
handling.

i.1.1 Document
• Codice del documento: MNT-10910-01-B
• Revisione del documento: B
• Data di revisione: 23 Aprile 2008

i.1.2 Instrument
• MIURA: p/n 10001-xx-A (xx=version)
• MIURA 200: p/n 10674-xx-A (xx=version)
• MIURA 100: p/n 10750-xx-A (xx=version)

i.1.3 Producer
• I.S.E. S.r.l.
Via delle Driadi, 45
00133 Roma – Italy
Phone: +39 06 20610289
Fax: +39 06 2018131
E-mail: info@logotech-ise.com
WEB: www.logotech-ise.com

i.2 Copyright
The content of this document, the pictures, the tables and the graphics included,
is intellectual property of I.S.E. S.r.l.
Unauthorized copies, total or partial, could cause legal actions in order to preserve
owner’s interests.

i.3 Purpose of This Document


This document defines and states the communication protocol used for the
instrument connection to the Laboratory Information System (L.I.S.). It is addressed
to technical personnel expert at Laboratory Information Systems setting up and
programming.

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MIURA Instrumentation Series
L.I.S. Connection – Technical Manual

i.4 Definitions, Acronyms ed Abbreviations


AD Applicable Document
FW Firmware
HW Hardware
L.I.S. Laboratory Information System
SW Software
TBD To Be Defined
TBC To Be Confirmed
TBV To Be Verified

i.5 Documentation

i.5.1 Applicable Documents


The proper MIURA Instrument User Manual.

i.5.2 Reference Documents


NCCLS, code LIS02-A2, Vol.24 Nr.33
“Specification for Transferring Information Between Clinical Laboratory Instruments
and Information Systems; Approved Standard—Second Edition”.

ASTM, code E1381-02


“Standard Specification for Low-Level Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer Systems”.

IEEE, 802.3
“Carrier sense multiple access with collision detection (CSMA/CD) access method
and physical layer specifications”.

ANSI, X3.15-1976
“Bit sequencing of the code for information interchange in serial by bit data
transmission (with ANSI X3.15-1976)”

ANSI, X3.16-1976
“Character structure & character parity sense for serial by bit data communication
in the code for information interchange (with ANSI X3.16-1976/R1983)”.

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L.I.S. Connection – Technical Manual

i.6 List of Contents


i.1 Identification Data .....................................................................................................2
i.1.1 Document ................................................................................................................2
i.1.2 Instrument.................................................................................................................2
i.1.3 Producer...................................................................................................................2
i.2 Copyright .....................................................................................................................2
i.3 Purpose of This Document.........................................................................................2
i.4 Definitions, Acronyms ed Abbreviations .................................................................3
i.5 Documentation ..........................................................................................................3
i.5.1 Applicable Documents..........................................................................................3
i.5.2 Reference Documents...........................................................................................3
i.6 List of Contents............................................................................................................4
1. General ........................................................................................................................5
2. System Configuration.................................................................................................5
3. Structure of This Document .......................................................................................6
3.1. Communication Physical Layer............................................................................6
3.2. Communication Level 1 ........................................................................................7
3.2.1. Connection Establishing Phase .....................................................................7
3.2.2. Conflict Resolution Phase...............................................................................7
3.2.3. Data Transfer Phase ........................................................................................7
3.3. Application Level....................................................................................................9
3.3.1. Header Message .......................................................................................... 10
3.3.2. PatientInformation Message ...................................................................... 11
3.3.3. TestOrder Message....................................................................................... 13
3.3.4. Result Message ............................................................................................. 16
3.3.5. Terminator Message..................................................................................... 18
3.3.6. RequestInformation Message..................................................................... 19
3.4. Communication Scenarios................................................................................. 20
3.4.1. Analysis Request – Communication Sequence....................................... 21
3.4.2. Analysis Results Request – Communication Sequence.......................... 22

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L.I.S. Connection – Technical Manual

1. General
This document describes the electronic transmission of digital data information
between a laboratory instrument and an information computer system. In
particular, in the following of this document the data exchange protocol has been
exposed and the connection schematic between the MIURA instrument (in the
following called Autoanalyzer) and the Host Computer (part of the Laboratory
Information System - in the following called Host) has been shown.
This kind of connection allows the “Autoanalyzer to/from Host” bi-directional
communication to improve automation in data request transmission (i.e.: work-lists
and patient data) and in patient final results data response.
This document finally defines the digital message structure allowing the data
transfer between Autoanalyzer and Host.

2. System Configuration
The communication between the Miura System and the external Host is compliant
to the IEEE 802.3 standard, that regulates the most common local area network
(LAN) technology based on Ethernet standard. The Miura System Personal
Computer is then provided with an internal network interface (Ethernet interface);
it is linked to the laboratory information local area network through a Hub or
through a Switch Hub the connects several other stations for communication
purposes. The Host Computer is obviously part of the same network and it is
connected in the same manner.
The following picture shows the functional diagram of connection.

MIURA FAMILY RS-232C


INSTRUMENT

MIURA PC HUB HOST PC


MIURA SYSTEM AUTOANALYZER

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L.I.S. Connection – Technical Manual

3. Structure of This Document


This document describes the electronic transmission of digital data.
It includes four main parts:
1. Communication Physical Layer
2. Communication Level 1
3. Application Level
4. Communication Scenarios.

3.1. Communication Physical Layer


The electrical connection for TCP/IP data transmission between the instrument and
the L.I.S. Host Computer has been described in the following.
The type of connection is not one-to-one (i.e.: Autoanalyzer-to-Host direct
connection), but a network central hub can be used.
Electrical voltage levels are compliant to the IEEE 802.3 standard.
The transmission exchange method is TCP/IP. The bit sequence, the transmitted
character structure and the parity check are compliant to the ANSI X3.15-1976
and X3.16-1976 standards.
The transmission speed (in accordance with IEEE 802.3) is at least 10MB/sec.

The TCP/IP computer port used for the connection is 4000.


The Host Computer:
• must get in connection,
• must run a “connect TCP/IP”, to the IP address assigned from the network
administrator to the MIURA System, directly on the 4000 port,
• on that port the MIURA Software is listening and ready to communicate.

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MIURA Instrumentation Series
L.I.S. Connection – Technical Manual

3.2. Communication Level 1


This level must guarantee the connection procedure carrying out, the outflow, the
sequence control, the error detection and recovering.
This communication level makes use of a protocol based on ASCII character
coding.
The information, in a defined moment, transfers in one direction only (one
communication element becomes “sender” the other one “receiver”) with the
message confirmation by the side of the receiver.
During the information transfer can be identified three different phases:

1. Connection establishing phase;


2. Conflict resolution phase;
3. Data transfer phase.

Those phases have been exposed in the following paragraphs.

3.2.1. Connection Establishing Phase


The “sender” notifies the “receiver” the need to transmit data by sending a <ENQ>
to the receiver. The receiver answers with <ACK> in order to confirm the availability
to receive data .
In that case the Data transfer phase can start.
On the other hand, in the event that the receiver answers <NACK>, the sender
must wait at least 10 seconds prior to try again to connect.
NOTE: during this phase the receiver can only receive <ENQ>, <ACK> e <NACK>.
Other messages are ignored.

3.2.2. Conflict Resolution Phase


If the receiver gets <ENQ> as the answer to its previous <ENQ> request, the
autoanalyzer (the instrument) has the priority to transmit data informations. The
Host Computer (L.I.S.) cannot send other messages and must wait for the next
<ENQ> coming from the autoanalyzer. In this case it must answer <ACK> and must
become receiver.
The instrument must wait a minimum time of 1 second prior to transmit the second
<ENQ>.

3.2.3. Data Transfer Phase


Messages are transmitted in “blocks”. Each block can contain 64,000 character at
most (including: header, crc, …). The block structure has been described in the
following table:

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L.I.S. Connection – Technical Manual

Chracters Description Value


<STX> Start of text 12H
FN Block number ‘0’-‘7’
text Message content
<ETX> End of text 13H
C1 Checksum Most Significant character ‘0’-‘9’ o ‘A’-‘F’
C2 Checksum Last Significant character ‘0’-‘9’ o ‘A’-‘F’
<CR> Carriage return 0DH
<LF> Line Feed 0AH

The block number hallows the receiver to recognize the block that have been re-
transmitted.
This number is sent as an ASCII character and it is increased for each message (the
number “7” is followed by the number “0”).
The checksum allows the receiver to recognize a message that has not been
correctly received. The checksum can be calculated as the arithmetic sum of all
received bytes without carry-over (the calculation doesn’t take into consideration:
<STX>, the checksum characters and the final <CR> and <LF> ).
The data transfer phase is terminated with the message <EOT> (End of Text) whose
value is: 04 hexadecimal (HEX).

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L.I.S. Connection – Technical Manual

3.3. Application Level


The list of message that can be sent has been shown in the following table:
Message Description Code
Header Defins fields delimiter ’H’
PatientInformation Information about the patient ‘P’
TestOrder Request of analysis ‘O’
Result Results ‘R’
Terminator End of data transmission ‘L’
RequestInformation Request of results ‘Q’

All fields related to the messages described in the following of this document must
always be present in order to allow the correct interpretation of the messages
themselves.
The fields the actually have no meaning for the MIURA System can be “nul value”,
that means: no character is send in between the headers.

Note – In the following Message Description Tables, the column MS (Miura


Sensitive) can get the following values:
• “N” - needed field - the field itself must have a value different from nul
• “O” - option field – the field itself can have any value (as well as nul)
because it is not used.

Note: In the following Message Description Tables, the column “L” defines the
message length for the fixed length fields. No value is inserted for the fields that
have no fixed length.

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L.I.S. Connection – Technical Manual

3.3.1. Header Message


Field Description L Values MS
RecordTypeID Message Identifier 1 ‘H’ N
DelimiterDefinition Delimiter definitions 4 Field delimiter I N
Repet delimiter \
Component delimiter ^
Escape delimiter &
MessageControlID O
AccessPassword O
SenderID “Miura” O
SenderStreetAddress O
ReservedField O
SenderTelephoneNumber O
CharacteristicsOfSender O
ReceiverID O
Comment O
ProcessingID Message 1 ‘P’ N
interpretation mode
(P-production)
VersionNumber 7 “LIS2-A2” N
DateAndTimeOfMessage 14 Format: N
YYYYMMDDHHMMSS

Where:
Field delimiter = vertical bar (|) Latin-1(124)
Repeat delimiter = backslash (\) Latin-1(96)
Component delimiter = caret (^) Latin-1(94)
Escape delimiter = ampersand (&) Latin-1(38).

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L.I.S. Connection – Technical Manual

3.3.2. PatientInformation Message


Field Description L Values MS
RecordTypeID Message Identifier 1 ‘P’ N
SequenceNumber Message sequence N
number
PracticeAssignedPatientID O
LaboratoryAssignedPatientI Patient Barcode N
D
PatientIDNumber3 O
PatientName Patient Name Surname ^ Name N
MotherMaidenName
Birthdate 8 Fomat: YYYYMMDD N
PatientSex 1 M, F, or U N
PatientRaceOrEthnicOrigin W - white O
B - black
O - Asian/Pacific Islander
NA - Native American/Alaskan
Native
H - Hispanic
PatientAddress O
ReservedField O
PatientTelephoneNumber O
AttendingPhysicianID O
SpecialField1 O
SpecialField2 O
PatientHeight O
PatientWeight O
PatientKnownOrSuspected O
Diagnosis
PatientActiveMedications O
PatientDiet O
PracticeFieldNumber1 O
PracticeFieldNumber2 O
AdmissionAndDischargeD O
ates
AdmissionStatus OP - outpatient O
PA - preadmit
IP - inpatient
ER - emergency room
Location O
NatureOfAlternativeDiagn O
osticCodeAndClassifiers
AlternativeDiagnosticCod O
eAndClassification
PatientReligion P - Protestant O

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L.I.S. Connection – Technical Manual

Field Description L Values MS


C - Catholic
M - Church of the Latter Day
Saints (Mormon)
J - Jewish
L - Lutheran
H - Hindu
MaritalStatus M - married O
S - single
D - divorced
W - widowed
A - separated
IsolationStatus ARP - antibiotic resistance O
precautions
BP - blood and needle
precautions
ENP - enteric precautions
NP - precautions for
neutropenic patient
PWP - precautions for
pregnant women
RI - respiratory isolation
SE - secretion/excretion
precautions
SI - strict isolation
WSP - wound and skin
precautions
Language O
HospitalService O
HospitalInstitution O
DosageCategory A - ADULT, N
P1 - PEDIATRIC (one to six
months),
P2 - PEDIATRIC (six months to
three years)
Location O

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L.I.S. Connection – Technical Manual

3.3.3. TestOrder Message


In this message the field UniversalTestID contains the necessary information to
identify the test to be run. It is composed by four elements delimited by the
character “^” (component delimiter).
The first and the third elements are actually not used.
The second element (barcode_test) is the barcode associated to the method to
be run (Note: the barcode have been defined by I.S.E. S.r.l. for all methods used by
the Miura system). See Note below to identify the value to assign to that field.
The last element (dil) symbolizes the code for the sample dilution ratio to be used
during the test execution.
Note: The Miura 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 previous older one.
This files is exported into a special folder for user handling; it can be copied on a
media or accessed by the 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 “MethodList” folder must be “shared” in network in order to allow an host
computer to download and treat the file itself.
The exported file is named method.csv (with delimiter “;”).
IT IS VERY IMPORTANT TO ACCES THIS FILE ANY TIME A NEW METHOD IS ADDED IN
ORDER TO UPDATE THE METHOD LIST.
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 Method Method
Acronym Barcode Internal Index

Fields meaning:
• Method Name: name given to the analysis method
• Method Acronym: acronym given to the analysis method.
• Method Barcode: identification barcode of the analysis method
(placed on the reagent bottle). Associate this value
to the second element of UniversalTestID.
• Method Internal Index: identification code of the analysis method.

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L.I.S. Connection – Technical Manual

Field Description L Values MS


RecordTypeID Message Identifier 1 ‘O’ N
SequenceNumber Message sequence N
number
SpecimenID O
InstrumentSpecimenID Patient Barcode N
UniversalTestID Identification if the ^barcode_test^^dil N
test method to be run
Priority Request priority 1 S stat N
A as soon as possible
R routine
C callback
P preoperative
RequestedDateAndTime Format: N
YYYYMMDDHHMMSS
SpecimenCollectionDateA O
ndTime
CollectionEndTime O
CollectionVolume O
CollectorID O
ActionCode 1 C cancel request for the N
battery or tests named

A add the requested tests or


batteries to the existing
specimen with the patient and
specimen

N new requests
accompanying a new
specimen

P pending specimen

X specimen or test already in


process

Q treat specimen as a Q/C


test specimen
DangerCode O
RelevantClinicalInformation O
DateTimeSpecimenReceiv O
ed
SpecimenDescriptor O
OrderingPhysician O
UserFieldNumber1 O

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L.I.S. Connection – Technical Manual

Field Description L Values MS


UserFieldNumber2 O
LaboratoryFieldNumber1 O
LaboratoryFieldNumber2 O
DateTimeResultsReportedO O
rLastModified
InstrumentChargeToInform O
ationSystem
InstrumentSectionID O
ReportTypes 1 O order record; user asking N
that analysis be performed
ReservedField O
LocationOfSpecimenColle O
ction
NosocomialInfectionFlag O
SpecimenService O
SpecimenInstitution O

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L.I.S. Connection – Technical Manual

3.3.4. Result Message


In this message the field UniversalTestID contains the necessary information to
identify the test and the patient whose result is transmitted. It is composed by four
elements delimited by the character “^” (component delimiter).
The first and the third elements are actually not used.
The second element (barcode_test) is the barcode associated to the method to
be run (Note: the barcode have been defined by I.S.E. S.r.l. for all methods used by
the Miura system).
The last element (barcode_paziente) symbolizes the code associated to the
patient.

Field Description L Values MS


RecordTypeID Message Identifier 1 ‘R’ N
SequenceNumber Message sequence N
number
UniversalTestID ^barcode_test^^barcode_paz N
iente
DataOrMeasurementValue Result value, in float N
format (i.e.: 23.354)
Units Measurement Unit N
(text containing the
used measurement
unit)
ReferenceRanges Reference values, in min-max N
format: min-max (i.e.:
0.2-3.45)
ResultAbnormalFlags L below low normal N

H above high normal

LL below panic normal

HH above panic high

N normal

A abnormal
NatureOfAbnormalityTestin O
g

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L.I.S. Connection – Technical Manual

Field Description L Values MS


ResultStatus 1 F final results N

X order cannot be done

I in instrument, results pending

W Warning: Validity is
questionable
DateOfChangeInInstrumen Standard, execution 14 Format: O
tNormativeValuesOrUnits date YYYYMMDDHHMMSS
OperatorIdentification O
DateTimeTestStarted O
DateTimeTestCompleted 14 Format: N
YYYYMMDDHHMMSS
InstrumentIdentification “Miura” N

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L.I.S. Connection – Technical Manual

3.3.5. Terminator Message


Field Description L Values MS
RecordTypeID Message Identifier 1 ‘L’ N
SequenceNumber N
TerminationCode 1 N normal termination N

T sender aborted

R receiver requested abort

E unknown system error

Q error in last request for


information

I no information available from


last query

F last request for information


processed

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L.I.S. Connection – Technical Manual

3.3.6. RequestInformation Message


In this message the field UniversalTestID contains the necessary information to
identify the test whose result has been requested. It is composed by four elements
delimited by the character “^” (component delimiter).
The first, the third and the fourth elements are actually not used.
The second element (barcode_test) is the barcode associated to the method to
be run (Note: the barcode have been defined by I.S.E. S.r.l. for all methods used by
the Miura system). If this field is empty, it means that all results obtained for the
patient identified by the barcode paziente have been requested. If the patient
barcode field is empty, it means that all results obtained for the method identified
by the field UniversalTestID have been requested.

Field Description L Values MS


RecordTypeID Message Identifier 1 ‘Q’ N
SequenceNumber N
StartingRangeIDNumber Patient Identifier Barcode paziente N
EndingRangeIDNumber O
UniversalTestID ^barcode_test ^^ N
NatureOfRequestTimeLimits O
BeginningRequestResultsDa O
teAndTime
EndingRequestResultsDate O
AndTime
RequestingPhysicianName O
RequestingPhysicianTeleph O
oneNumber
UserFieldNumber1 O
UserFieldNumber2 O
RequestInformationStatusC P preliminary results N
odes
F final results

X results cannot be done,


request cancelled

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L.I.S. Connection – Technical Manual

3.4. Communication Scenarios


In the following sub-paragraphs the communication scenarios under functional
block form have been shown in sequence.

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L.I.S. Connection – Technical Manual

3.4.1. Analysis Request – Communication Sequence

L.I.S.
MIURA MIURA
L.I.S. Server

<ENQ>
Communication
request with
positive feedback
<ACK>

<STX>PatientInfo<ETX>

Patient Info
<ACK>

<STX>TestOrder<ETX>

Add analysis

<ACK>

<STX>Terminator<ETX>
End of
transaction

<ACK>

<EOT>

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L.I.S. Connection – Technical Manual

3.4.2. Analysis Results Request – Communication Sequence

L.I.S.
MIURA MIURA
L.I.S. Server

<ENQ>
Communication
request with
positive feedback
<ACK>

<STX>RequestInfo<ETX>
Query over
results
<ACK>

<STX>Result<ETX> Data
formatting

<ACK>

<STX>Terminator<ETX>

<ACK>

<EOT>

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