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MEK-9100 Service Seminar

System Connection
System Connection
 Basic knowledge about LAN
 Medical information standardization
 What is HL7?
 Connection test for HL7
 Validation scenario
 Setting the IP address
 Using the validation tool
 Serial connection
 ASTM format
MEK-9100 Service Seminar

BASIC KNOWLEDGE OF LAN


LAN
 A local area network (LAN) is a computer network that
interconnects computers within a limited area such as a
residence, school, laboratory, or office building.

 In modern, LAN is generally used with combination of


physical standards of "Ethernet" and the communication
protocol of "TCP / IP"

 MEK-9100 supports TCP/IP (IPv4). TCP/IP (IPv6) will be


supported later.
TCP/IP (IPv4)
 TCP / IP is a communication protocol used in standard in
the Internet (communication procedure).
 It is TCP (Transmission Control Protocol) and IP a
combination of (Internet Protocol).
 It is the generic name of the entire protocol of Internet
standard which includes the TCP and IP.
 In the TCP / IP properties, there are three main entry.
 IP address
 sub-net mask
 gateway
If they are not set correctly, it is impossible to communicate
with LAN.
TCP/IP (IPv4)
 In the case of IPv4, IP address is the TCP / IP network
numerical value that uniquely identifies a single host with 32
bit (computer or printer or device such as a router) .

 Normally, IP address is represented in decimal format of


dotted, it will consist of four numbers separated by periods
(for example, 192.168.123.132).

 The IP address contains two parts. The first part of the IP


address is used as a network address, and the rest will be
used as the host address.
Subnet Mask
 In the TCP / IP protocol, the subnet mask is used to
discriminate whether the host is on the local subnet, or on
the remote network.
 By comparison of the IP address and subnet mask, you can
separate the network ID and host address.
 IP address (192.168.123.132) :11000000.10101000.01111011.10000100
 Subnet mask(255.255.255.0) :11111111.11111111.11111111.00000000

 In this example, the subnet mask [255.255.255.0] shows,


 Network ID is [192.168.123.0]
 Host address is [0.0.0.132].
Default Gateway
 If a computer needs to communicate with a host on
another network, it usually communicates through a
device called "Router".
 Router that links the subnet of the host to other networks,
is called "Default Gateway" in the TCP / IP terms.

 When a host PC
communicates with other
devices with TCP / IP, the
subnet mask discriminates
whether the host is a local host
, or a remote host.
Subnet Mask and Default Gateway
 If the destination is a local host, the data packet is sent from
host to the local subnet.
 If the destination is a remote host, the packet transferred to a
default gateway that defined in the TCP / IP properties of the
computer.

From http://www.highteck.net/
MEK-9100 Service Seminar

BACKGROUND OF MEDICAL
INFORMATION
STANDARDIZATION
Background of Medical Information Standardization

 Medical care
Previously doctors controlled all the medical practices
and patient information; the current trend is team
medicine, hospital/primary care coordination, remote
diagnosis, regional medicine, home medical care, and
outsourcing
 Information
Previously medical records held by the individual doctors
were sufficient; today the importance of standardization
and objective analysis is recognized as specialization,
coordination, and informed consent becomes more
commonplace
Background of Medical Information Standardization

 Standards
To share information, it must be objectively described,
recorded, and communicated according to certain rules.
That set of rules is the standards.
 Multi-vendor system
No manufacturing company can cover all of the
operational systems. Standardization is imperative for
efficient system development.
Environment Surrounding Celltac

 MEK-9100's target → Small and medium-scale hospital market


 Lower the cost of connecting systems used in different operations
 More upper-level systems are supporting the data transfer standards

Standards are becoming required for testing equipment



To support HL7, the international standard for transfer of clinical
and administrative data
Workflow of Hospital Case in Japan
Blood collection room
labeling sampling
order

Patient
reception
Examination

review

Analyzer

Medical prescription
HL7 workflow
Laboratory
MEK-9100 supports HL7 protocol
MEK-9100 Service Seminar

WHAT IS HL7?
What is HL7?
First standard came out in 1987

International standardization in 2009


(ISO 27931:2009)

Developed a communication network


for all operations in a hospital

From HL7 International <http://www.hl7.org/>


HL7 is...
 A set of standardized rules for the exchange of medical information, including the
following:
 Patient management ■Orders ■Queries
 Financial affairs ■Master files ■Test
reporting
 Information management ■Reservation ■Patient
referral
 Patient care ■Laboratory automation
 Application management ■Personnel management
 HL7 is an abbreviation for Health
Level Seven, and this name is a
reference to the seventh layer of
the ISO OSI Reference model also
known as the application layer for
exchanging information between
medical applications.

From HL7 International <http://www.hl7.org/>


Overview of HL7 (Health Level Seven)
Version 1.0 was published in 1987.
The current version is version 3.0.
Version 2.5 was established as an ISO standard.
• 1972: Duke University became the first to use HIS. Applications are mostly medical tests.
• 1985: Clem McDonald and Ed Hammond begin the standardization of test results as ASTM (E-1238).
• 1987: University of Pennsylvania hosts conference; HL7 is named as the seventh layer of the
ISO Open Systems Interconnect Communication Model.
• 1987: Version 1.0 is released in September, compliant with E1238. HL7 specializes in top priority
standards with a focus on development speed.
• 1989: Version 2.0 is released; No responsible office existed for HL7, with little user support.
• 1990: Version 2.1 is released. Competition for standardization arises among SDOs, with CEN also
making an approach.
• 1994: Version 2.2 is released; HL7 is accredited as ANSI ASC.
• 1995: Version 2.2 becomes an ANSI standard.
• 1997: Version 2.3 is released; Version 3 covers insurance claim attachments.
• 1998: Version 2.3.1 is released.
• 2001: Version 2.4 is released.
• 2002: Version 2.5 ballot; ISO pilot project
• 2004: Version 2.6 ballot
• 2007: Version 2.6 is released.
• 2009: ISO/HL7 27931:2009 Version 2.5
• 2010: Version 2.7 is released.
• 2012: Version 2.8 under development
From HL7 International <http://www.hl7.org/>
Overview of HL7 (Health Level Seven)
The name comes from the encoding rules for the application layer that
deals with health care information, which is the seventh layer of the OSI
Reference model.
OSI Reference Model TCP/IP

(Open Systems Interconnection reference model)


7. Application Layer Provides data communication service to the
application program
HTTP, FTP

6. Presentation layer Converts/Reverses data representation format

5. Session Layer Procedure from the start to the end of data


communication

4. Transport Layer Corrects errors in data transfer and controls re-


transmission
TCP, UDP

3. Network Layer Communication method between two points on a


network (routing)
IP

2. Data Link Layer Data packeting, communication between


adjacent nodes, error checking
ETHERNET

1. Physical Layer Electrical or physical specifications of the


communication line (modulation, etc.)
UTP cable,
RS-232C

From HL7 International <http://www.hl7.org/>


Overview of HL7 (Health Level Seven)
There are more than 30 international offices worldwide.

From HL7 International <http://www.hl7.org/>


The Standard.. yet.
 Problems of standards adoption.
 It allows various interpretations when adopted.
 Lowering of interoperability due to the difference in standards
interpretation.
 It can't connect when different interpretation happens between
companies adoption.
 It does not achieve the expected information cooperation
 Man-hours will be wasted to avoid.
 It may cause problems in the cost and quality.

It needs a unified
interpretation for system
construction

Integrating the Healthcare Enterprise (IHE)


IHE (Integrating the Healthcare Enterprise)
 IHE is an initiative by healthcare professionals and industry to
improve the way computer systems in healthcare share
information.
 IHE promotes the coordinated use of established standards such
as DICOM and HL7 to address specific clinical needs in support of
optimal patient care. Systems developed in accordance with IHE
communicate with one another better, are easier to implement, and
enable care providers to use information more effectively.
 IHE improves healthcare by providing specifications, tools and
services for interoperability. IHE engages clinicians, health
authorities, industry, and users to develop, test, and implement
standards-based solutions to vital health information needs.
IHE is an association who makes a guide how to use the HL7.

MEK-9100 was pass the test of IHE connectathon


test.
Structure of the HL7 Technical Framework

Technical Framework

Consolidated Profile
Defines the test scenario

Transaction

Defines the detailed specifications of the


HL7 messages for implementing the test
scenario
IHE – Integration Profiles
Classifyingand
Classifying andModeling
Modelingthe
thenecessary
necessary
workflow in
workflow ineach
eachinspection
inspectionareas.
areas.
 LTW ・・ Laboratory Testing Workflow
( Order Filler, Order Placer, Order Result Tracker )
 LTW-MB ・ Laboratory Testing Workflow (MicroBiology)
( Order Filler, Order Placer, Order Result Tracker )
 LAW ・・・ Laboratory Analytical Workflow
( Analyzer, Analyzer Manager )
 LDA ・・・ Laboratory Device Automation
( Analyzer, Automation Manager, Pre/Post-processor )
 LBL ・・・ Laboratory Barcode Labeling
( Label Broker, Label Information Provider )
For Cellac
 LPOCT ・・ Laboratory Point Of Care Testing
( Order Filler, Point Of Care Data Manager )
 GIR ・・・・ Graphics and Simple Images in Results
( Order Filler, Order Result Tracker )
LAW actors
 [AM] : Analyzer manager
 It is the System for managing the clinical
laboratory of IVD testing device [Analyzer]
(Ex. Clinical test system).
 It is as a middleware.
 [AM] requests the measurement order
information for the [Analyzer]
 [AM] receives the measurement result from the
[Analyzer]
LAW actors
 [Analyzer] : IVD testing device
 Generic term for the analyzer used for clinical
laboratory.
 It measures the sample in accordance with the
contents of order information [AWOS] which
received from [AM].
 It sends the measurement results to [AM].
Transaction of LAW profile

Order Filler AM ANALAYZER


Test Order
Test Order (LAB-28)
AWOS Broadcast

Sample
Test Order Query(LAB-27) Arrival
Query for AWOS

Test Order (LAB-28)


AWOS Broadcast

Test
Test Result (LAB-29) Done
AWOS Status Change, Change with Results

Test Result

(※) AWOS(Analyzer Work Order Step) :


→ Order that are directed by the AM to the Analyzer
MEK-9100 Service Seminar

HL7 CONNECTION TEST


Test Scenario

 It is necessary to check in accordance with the HL7 technical


framework.

 The HL7 test should be done only the portion that is used for the
actual flow of the blood test.

 Other workflows should be ignored.


Test Scenario
 Test is performed following the scenario below
 CASE1:
If it is possible to read the barcode affixed to the sample tube,
and the analyzer can query the upper-level system for test
orders:
 CASE2:
If not reading the barcode on the sample tube:
 CASE3:
If transmitting order information from the LIS to analyzer:
 CASE4:
If it is possible to receive the analysis results produced by the
analyzer based on an order it received from the LIS.
Test Scenario
 Test is performed following the scenario below
 CASE5:
If receiving analysis results based on an order generated by the
analyzer:
 CASE6:
If receiving manually-analyzed results:
 CASE7:
If performing QC management from the LIS using the control for
QC:
 CASE8:
If using scattergram and histogram images:
Test Scenario
 CASE1:
If it is possible to read the barcode affixed to the sample
tube, and the analyzer can query the upper-level
system for test orders:
 LAB-27 Perform the sample ID query test.

Barcode
reading

Query
Test Scenario
 CASE2:
If not reading the barcode on the sample tube:
 If it is possible for the analyzer to query for test
orders based on the position information of the
sample tube in the rack:
LAB-27 Perform the sample tube position query
test.

Information of Query
Rack position
Test Scenario
 CASE3:
If transmitting order information from the LIS to analyzer:
 LAB-28 Perform the order reception test.

Order
Test Scenario
 CASE4:
If it is possible to receive the analysis results produced by
the analyzer based on an order it received from the LIS:
 LAB-29 Perform the order-based analysis results
transmission test.

Order from LIS

Result
Test Scenario
 CASE5:
If receiving analysis results based on an order
generated by the analyzer:
 LAB-29 Perform the analyzer-generated order-
based analysis results transmission test.

Order from Instrument

Result
Test Scenario
 CASE6:
If receiving manually-analyzed results:
 LAB-29 Perform the manual analysis results
transmission test.

Result
Test Scenario
 CASE7:
If performing QC management from the LIS using the
control for QC:
 LAB-29 Perform the QC results transmission test.

QC

Result of QC
Test Scenario
 CASE8:
If using scattergram and histogram images:
 LAB-29 Perform the image output transmission
test.

scattergram
& histogram

image
output
HL7 Message
 Example of HL7 message
Order Query from [ANALYZER] to [AM] (LAB-27)
MSH|^~¥&|MEK-9100|Laboratory|LIS|Laboratory|20150903143044||QBP^Q11^QBP_
Q11|ID201509031430440003|P|2.5|||NE|AL||UNICODE UTF-8|||LAB-27^IHE<CR>
QPD|WOS_BY_RACK^Work Order Step by Rack^IHELAW|ID201509031430440004||0210|8<CR>
RCP|I||R^Real Time^HL70394<CR>

Order from [AM] to [ANALYZER] (LAB-28)


MSH|^~¥&|LIS|Laboratory|MEK-9100|Laboratory|20150903143047||OML^O33^OML_
O33|LAWAM00000004|P|2.5|||NE|AL||UNICODE UTF-8|||LAB-28^IHE<CR>
PID|||1234567890||Smith^John^^^^^L||19800502|M<CR>
PV1|||Room0001<CR>
SPM|||||||||||P^Patientspecimen^HL70369<CR>
SAC||||||||||0210|8<CR>
ORC|NW<CR>
OBR|1|20150903101333||CBC^CBC order^99UNK||||||||||||12345^Roe^Richard<CR>
ORC|NWCR>
OBR|1|20150903101333||DIFF^WBC Differential order^99UNK||||||||||||12345^Roe^Richard<CR>
MEK-9100 Service Seminar

NETWORK SETTING
Connect LAN cable

 Connect a LAN cable to the connector which is located on


the rear side of the instrument.

LAN connector
IP Address Setting

 Show “Home” screen.

 Press [SYSTEM] button to show


“SYSTEM” screen.

 Press [▼] pull-down button.

 Press “+” mark to show “External output


setting” screen.

 Press “+” mark in the “LAN”


setting. Enter IP address.
IP Address Setting

Host IP address :
Set the IP address of the device
(such as LIS) the analyzer is
connected to.

Device IP Address :
Set the IP address of the
analyzer.
(default : 192.168.2.1)

Default Gateway Address : Device Sub Net Address :


Set the Default Gateway Address of Set the Sub Net Address of the
the analyzer. analyzer.
(default : 192.168.2.1 ) (default : 255.255.255.0)
IP Address Setting
Work order request port
Sets the communication port
number to request orders from a
system such as HIS or LIS.
(default:50001)

Receive work order port


Sets the communication port
number to receive order from a
system such as HIS or LIS.
(default:50002)

Send results port


Sets the communication port
number to send measurement
results to a system such as HIS or
LIS.
(default:50003)
Work Orders settings
 Case of test order
 Analyzer Only

 Linked with HIS,LIS


Work Orders settings

 Show “Home” screen.

 Press [SYSTEM] button to show


“SYSTEM” screen.

 Press [▼] button in right side scroll bar to


show the item of “Work Orders”.

 Press “+” mark to expand


“Work Orders setting” screen.
Work Orders settings

LIS connection :
Set the queried the order.
 None:
No Order connection.
 Order Query + warning:
It automatically queries the
order to the host system,
and report the results.
 Order Reception + warning:
Order cooperation key: It measures by the order of
from the host system, and
Set the conditions of the order
report the results.
inquiry.
 Warning Only:
 Specimen ID It sends the result only to
 Sampling tube location the host system.
Work Orders settings

Unidentified ID:

Set default ID number that the case


of sample has no barcode, and has
no order from host system.

Operation of Order failure:


Set the operation when it fails to
get the order. Default setting
Set the order that the case of order
 Default order
failure.
Measured with a default order  CBC
 Cancel.  CBC+DIFF
Cancel the measurement.
External Output setting

 Show “Home” screen.

 Press [SYSTEM] button to show


“SYSTEM” screen.

 Press [▼] button in right side scroll bar to


show the item of “External Output”.

 Press “+” mark to expand


“External Output setting” screen.
External Output setting
System Setting > External Output > Auto Output After Meas,

If the “Data transfer to LIS


after Measurement” is set to
“Yes” to sent to the external
output after the measurement
is completed.
 Yes :
 No :

(*)To transfer the measured


data, this setting should be set
to “Yes”.
MEK-9100 Service Seminar

ORDER LIST
Order List Window
 The order can be displayed, set or
edited in the Order List window.

 Open the “Home” screen.

 Touch [Orders] on the “Home”


screen to open the “Order List”
window.
Order List Window
Check box
• Touch to select
the order to edit,
print or delete
and display the
check mark.

[▼]
Opens the Order
List Filter window
filter the orders.

Select the order to display. Edit, print or


[Not Done]:Displays unprocessed (not done) orders. delete the
[All]: Displays all orders. selected order.
Order List Window
 Filtering Orders
 Touch [▼] to open the “Work
Orders Filter window.”

Paramaeters Details

Sample ID Touch the measurement item to display a keyboard, and enter the sample ID

Patient ID Touch the measurement item to display a keyboard, and enter the patient ID.

Test Items Touch [▼] to display the pull-down menu, and set the measurement items..

Rack No. Touch [▼] to display the pull-down menu, and set the rack number.

Work Order eceived Touch [▼] to display the pull-down menu, and set the range for the order received
Date and Time date and time. If you touch [Today], today's date is set automatically.
MEK-9100 Service Seminar

HOW TO USE TEST TOOL


System Connection
 System connection with the hospital of LIS or HIS to
MEK-9100 will be tested after installation.

 Device can not operate if there is any trouble.

 By the test tool, it is possible to test the connections to


the hospital LIS or HIS without MEK-9100 .

 Build a state of the system that MEK-9100 can be


connected to LIS before installation.
How to use the tool
 Copy a folder-by-folder basis of
test tool to any directory.

 Click “HL7SIM.EXE”.

 Select [UNICODE UTF-8] from


pull-down list of the character
encoding in the field of "HL7
Receive Message Char Code”.

 Select [Work Order Request from


[Sample ID] or [Aspiration tube Position]
Transaction of LAW profile

Order Filler AM ANALAYZER


Test Order
Test Order (LAB-28)
AWOS Broadcast

Sample
Test Order Query(LAB-27) Arrival
Query for AWOS

Test Order (LAB-28)


AWOS Broadcast

Test
Test Result (LAB-29) Done
AWOS Status Change, Change with Results

Test Result

 It is sufficient to verify the LAB-27, LAB-28, and LAB-29


LAB-27 Test
 LAB27
Do following steps.
 STEP1
Enter “IP address” and “Port
Number” of LIS.
 STEP2
Enter identification of sample

 STEP3
Press “Query Order” button to request order to LIS.
 STEP4
Received message is shown in lower column.
Check all test result are “Pass”. If the result is shown as “Fail”,
correct connection refer from the result message.
LAB-28 Test
 LAB28
Do following steps.
 STEP1
Enter “IP address” and
“Port Number” of your PC.
Press ”Receive” key
 STEP2
Received message is
shown in lower column.

Check all test result are “Pass”.


If the result is shown as “Fail”, correct connection refer from the result
message.
LAB-29 Test
 LAB29
Do following steps.
 STEP1
Enter “IP address” and “Port
Number” of LIS.
 STEP2
Select a data from “Received
Order List” pull-down list.

 SETP3
Select one data from “Measured data” pull-down list.
 STEP4
Press “Send Measured Data” button to send measured data to
LIS.
 STEP5
Check all test result are “Pass”. If the result is shown as “Fail”,
Test result
 Test result is shown at “Result” column.
 Pass
 Fail
Click [Error] radio button to show the error detail on right
side column.
LAB27
Test result
 Test result is shown at “Result” column.
 Pass
 Fail
Click [Message] radio button to show the transferred
message detail on right side column.
LAB27
Judgment

 To pass in all scenarios to adopt.

 Celltac can be connected to LIS


immediately after installation.
MEK-9100 connection with HL7

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