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RIDA qLine® Soft

Interface Description

R-Biopharm AG, An der Neuen Bergstraße 17, D-64297 Darmstadt, Germany


Tel: +49 (0) 61 51 81 02-0 / Fax: +49 (0) 61 51 81 02-20
Introduction
®
RIDA qLine Soft is the analysis software for RIDA qLine Allergy, a quantitative line blot system for detection of
specific IgE antibodies for up to 20 individual allergens on a nitrocellulose membrane in the context of in vitro
allergy diagnostics.
The program allows both manual entry and importing of requests from external computer systems, with
compilation of the requests into work lists. The developed strips are measured by a 3D flatbed scanner both
validated and approved by R-Biopharm. The analysis can also optionally be performed with a RIDA® X-Screen
(MATEST Systemtechnik GmbH).
Based on the 5 standards that are present on every membrane, the program creates a standard curve for
analysis of the test results. At the same time, the creation of the standard curve serves as a function check.
After the measurement, the results are either printed out, saved as a PDF or returned online to the laboratory
computer system. RIDA qLine® Soft is therefore a comprehensive program for analysis of the optical density of
a biochemical reaction, measured via scanner or RIDA® X-Screen, compared to the background surrounding the
specimen.
®
The symbols in yellow in the graphics are part of the RIDA qLine Soft system. Either they are modules that go
with the program or data in a specific format that were generated by the program so they can be shared with
other third-party systems.
Symbols in green are third-party products or data generated by those products and linked via interfaces to the
®
RIDA qLine Soft system.

1 Description of Interfaces
The workflow through the software is taken directly from RQL-249 - Overview of processes to be supported by
the software. The process diagram of the UI components seen here shows how the workflow is implemented

Scanned image

save

Sender UI Image UI

Results
New/ Measure print
sender „show measurement“
Create
worklist measure
Requests UI Worklists UI Results UI

print

Export
Export request
result
Worklists

Figure 1 UI workflow

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RQL-202 - Interfaces
The following equipment interfaces are available for measuring devices:
• TWAIN interface for flatbed scanner
The TWAIN interface activates the supported flatbed scanners. Available only in version 1.2.

®
• TWAIN interface for RIDA qLine Scan

®
• RIDA qLine autoBlot interface.
Available from version 2.2.

The following data interfaces are available:


• LIS ASTM interface
Import of test requests and return of test results via the ASTM protocol.

• Import of test requests via CSV file


Test requests are imported via a CSV file. Patient data can also be imported.

• Save recorded image


The image recorded by the scanner can be saved as a JPEG file.

• Export measured test request


Used primarily for support tasks. The test request and the strips recorded by the scanner can be sent
to R-Biopharm. The export is in the form of a readable XML file.
No patient data is transferred.

• Export result of test request


Used to transfer results to a third-party system. The export is in the form of a readable XML file.

• Transfer result to Windows Clipboard


Supports simple exchange with external software, e.g., spreadsheet calculations.

RQL-514 - Overview of interfaces


The interfaces are divided into the following types:
• Device interfaces

• Data interfaces

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1.1 Device interfaces
RQL-479 - Overview of device interfaces

Flatbed scanner

RIDA qLine® Soft

RIDA qLine® Scan

Figure 2 Overview of device interfaces

The following devices are supported:


• Flatbed scanners
The flatbed scanners must be addressable via the TWAIN interface and have a sufficient depth of field.
The Epson Perfection V600 is enabled and recommended for measurement.

®
• RIDA qLine Scan
is a special flatbed scanner that supports the TWAIN interface.

RQL-480 - Flatbed scanners


The flatbed scanners must have a manufacturer-supplied TWAIN driver through which it is addressable.
Sufficient depth of field is required for image recording. The system can be checked via the QC functionality.

RIDA qLine® Flatbed scanner


TWAIN driver
Soft

Figure 3 Connecting the flatbed scanner


®
For the Epson Perfection V600 flatbed scanner, the driver can be installed along with RIDA qLine Soft.

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RQL-481 - RIDA qLine® Scan
®
RIDA qLine Scan is offered as an independent device and is IVD-approved.

RIDA qLine®
RIDA qLine® RIDA qLine®
Scan
Soft Scan driver

®
Figure 4 Connecting the RIDA qLine Scan
® ®
The driver for the RIDA qLine Scan can be installed along with RIDA qLine Soft.

1.2 Data interfaces


RQL-470 - Overview of data interfaces

Recorded image Test request incl. image


Test request result
Test request import
Support import

Figure 5 Overview of data interfaces

The interfaces are divided into 3 different groups:


• Test request import
®
Test requests from a third-party system can be read into the RIDA qLine Soft system. Patient data can
also be processed, if desired.
• Test request result export
The results of test requests are transferred to third-party systems for post-processing. Patient data are
transmitted depending on the interface and configuration.
• Support
Used primarily for support. No patient data is transferred.
Test request import

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• CSV import
Test requests are made available in a defined CSV file from the third-party system and can be read in.

• LIS ASTM interface


The test requests captured in the LIS can be retrieved and imported. The interface is bi-directional for
the subsequent return transmission of results. The ASTM protocol is used for communication.

Test request result export


• XML export
The results data are exported in a defined XML file for each test request. Patient data such as name
and date of birth are not exported. A laboratory ID must be used for allocation.

• LIS ASTM interface


Results data can be sent to a connected LIS via the ASTM interface. Only those test requests imported
via the LIS ASTM interface are considered. The ASTM protocol is used for communication.

• Clipboard
The clipboard can be used for easy exchange of results data with standard applications, such as
spreadsheet calculations for example. No patient data is transferred. A laboratory ID must be used for
allocation.

Support
• Recorded image
The image recorded by the measuring device can be saved. This supports easy assessment in the event
of analysis problems.

• Test request incl. image


The test request data, without patient data, and the test strips cut from the recorded image are saved
to an XML file.
®
Another RIDA qLine Soft installation can read and re-analyze this file.

1.2.1 LIS ASTM


RQL-270 - LIS interface architecture
The ASTM interface is based on the ASTM specifications:
• ASTM E1381 (low level protocol)
• ASTM E1394 (high level protocol)
The only low level protocol supported is TCP/IP, which is described in Chapter 7 of the above-mentioned
specifications.
By using the TCP/IP protocol it underlies the architecture for the entire system, as illustrated in the following:

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Figure 6 LIS interface architecture

Component Description

®
qLine Soft Represents the RIDA qLine Soft software with which the user works.

RLink LIS ASTM This is the interface component that implements the LIS connection
via the ASTM protocol.

®
qLine Soft Central database where RIDA qLine Soft stores all relevant data.
Database The application program as well as RLink LIS ASTM use the database.

LIS The laboratory information system in the laboratory.


Test requests are centrally recorded here and called up by RIDA
®
qLine Soft for further processing in the laboratory environment.

Log files Log files saved by RLink LIS ASTM.

Table 7 LIS connection components

The components are interconnected via standardized interfaces. Both interfaces have to be configured during
installation.

Interface Description

DataSnap An Embarcadero Technologies protocol that transfers data from one


application to another. It supports extremely easy set-up of a multi-
tier environment. TCP/IP is used as the transport protocol.

ASTM (TCP/IP) Protocol that enables access to the LIS.

Table 8 LIS connection protocols

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The following process is implemented during the LIS connection. The ASTM interface supports communication
®
between the RIDA qLine Soft system and the laboratory information system.

ASTM protocol
Lab information system
Create lab IDs Send lab IDs

Compile RIDA qLine® test


requests for lab IDs
Import
test requests
create worklists Send back test requests

Work in the laboratory

Measure/analyze

Send results to LIS


Result

Result import

Figure 9 LIS connection process

RQL-468 - General definitions


Delimiters
The following delimiters are always defined in the message header record:
Table 1 Delimiters

Character Meaning

vertical bar (|) Latin-1 Field delimiter


(124)

backslash (\) Latin-1 (96) Repetition delimiter

caret (^) Latin-1 (94) Component delimiter

ampersand (&) Latin-1 Escape delimiter


(38)

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Date fields
The ASTM specification defines a special date format as well as a format for a time stamp (date and time
specification), see Chapter 6.6.2. The interface also allows a timestamp with plain date fields. The time
specification is not analyzed.

RQL-462 - Message header record


ASTM E1394-97 Chapter 7

No. ASTM field Description From To


LIS LIS

1 Record Type H x x

2 Delimiters Delimiter x x
Definition Standard “|\^&”

5 Sender Name or From LIS: LIS host x x


ID To LIS: qLine “RBIO-Link RqL”

10 Receiver ID From LIS: Currently ignored x x


To LIS: qLine “RBIO-Link RqL”

12 Processing ID Always “P” x x

13 Version Number E 1394 x

14 Message Date Standard format: “YYYYMMDDhhmmss” x x


and Time

Examples:
From LIS to RBIO link
The sender who sent in the following patients, including test requests, is passed.
H|\^&|||MyLis||||| RBIO-Link RqL (1.1)||P| E 1394-97|20170628100713<CR>

From RBIO link to LIS


Response to requests from Example 1. The measurement took place one day later.
H|\^&|||RBIO-Link RqL (1.1)|||||MyLIS||P|E 1394-97|20170628100713<CR>
In the example, lis_name is the name of the LIS system that is entered in the configuration.

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RQL-463 - Patient information record
ASTM E1394-97 Chapter 8

No. ASTM field Description From To


LIS LIS

1 Record Type P x x

2 Sequence Sequential number of the patient x x


Number

3 Practice Assigned Ignored


Patient ID

4 Laboratory External ID from LIS with which the patient can be x x


Assigned Patient referenced.
ID

6 Patient Name Name of patient (x) (x)


Last name^First name

8 Birthdate Format: YYYYMMDD or YYYYMMDDhhmmss (x) (x)

9 Patient Sex Gender (x) (x)


M – Male; F – Female; U – Unknown

11 Patient Address Patient address (x) (x)


Street^City^^ZIP

13 Patient Telephone number (x) (x)


Telephone e.g., 02499 8995

Example 1: Only patient ID is transmitted, no name or address


P|1||P2375511

Example 2: Patient with name and partial address


P|1||P2375511||last-name^first-name||19990510000000|M

or
P|1||P2375511||last-name^first-name||1999051|M

Example 3: Patient with name and full address


P|1||P2375511||last-name^first-name||1999051|M||MyStreet 11^MyCity^^4711||030 11121314

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RQL-464 - Test order record
ASTM E1394-97 Chapter 9

No. ASTM field Description From LIS To LIS

1 Record Type O x x

2 Sequencs Sequential number of the patient request. x x


Number A patient can have multiple test orders

3 Specimen ID Lab ID x x

5 Universal Test ID Test ID x x


^^^test_id
The Test ID can be modified using a mapping
table.

7 Requested Date Creation time stamp, format: YYYYMMDDhhmmss x x


and Time

Example 1: Order for Lab ID 11223344.


O|1|11223344||^^^RqL_Std1||20170216130539

Example 2: Same order, only with recorded date, no time stamp


O|1|11223344||^^^RqL_Std1||20170316

RQL-465 - Result record


ASTM E1394-97 Chapter 10

No. ASTM field Description From To


LIS LIS

1 Record Type R x

2 Sequence Number Sequential number of the result for the test x


request.
One test request can have multiple results.

3 Universal ID ^^^alg_code x
alg_code is the allergen code used in the LIS.
It can be defined using a mapping table.

4 Data Measurement Measurement result x

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For example: 36.8

5 Units Unit of measurement result x


IU/ml

6 Reference Ranges Associated class x

9 Result Status Status of result x


Always F - Final results

13 Date/Time Time stamp of when the finding took place. x


Completed Format: YYYYMMDDhhmmss

Example: Result for allergen D1


R|1|^^^D1|36.10|IU/ml|4.0^High|||F

RQL-466 - Request information record


ASTM E1394-97 Chapter 12

®
The LIS responds to this message exclusively with test requests that can be processed with the RIDA qLine
system.

No. ASTM field Description From To


LIS LIS

1 Record Type Q x

2 Sequence Number Seq. number x

3 Starting Range ID Records the LAB ID used for calling up x


test requests
^labor_id

13 Request Information O - Query for test requests x


Status Code

®
Example 1: The RIDA qLine test requests are queried for Lab ID 11223344.
Q|1|^11223344||||||||||O
®
Example 2: The RIDA qLine test requests are queried for 3 different Lab IDs.
Q|1|^11223344||||||||||O
Q|2|^22223355||||||||||O
Q|3|^33223366||||||||||O

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RQL-467 - Message terminator record
ASTM E1394-97 Chapter 13

No. ASTM field Description From To


LIS LIS

1 Record Type L x x

2 Sequence Number Seq. number x x

3 Termination Code N x x

Example
L|1|N

RQL-469 - Communication examples


Example 1: Querying test requests for specific Lab IDs
H|\^&|||RBIO-Link RqL (1.1)|||||MyLIS||P|E 1394-97|20170220155710
Q|1|^A99887766||||||||||O
Q|2|^A997777||||||||||O
L|1|N

Example 2: Test requests from LIS for the Lab IDs


H|\^&|||MyLis||||| RBIO-Link RqL (1.1)||P| E 1394-97|20170220155810
P|1||998888||last-name^first-name||19580801000000|F
O|1|A99887766||^^^RqL_Std2||20170220160210
O|2|A99887766||^^^RqL_Std1||20170220181748
P|2||997777||last-name-2^first-name-2||19580801000000|F
O|1|A997777||^^^RqL_Std1||20170220170000
O|2|A997777||^^^RqL_Std2||20170220170000
O|3|A997777||^^^RqL_Std1||20170220170000
L|1|N

Example 3: Results to LIS


H|\^&|||RBIO-Link RqL (1.0)|||||MyLis||P|E 1394-97|20170220155810
P|1||998888||last-name^first-name||19580801000000|F
O|1|A99887766||^^^RqL_Std2||20170220160210
R|1|^^^D1|36.10|IU/ml|4.0^High|||F
...
R|25|^^^D2|36.10|IU/ml|4.0^High|||F
O|2|A99887766||^^^RqL_Std1||20170220181748
R|1|...
...
P|2||997777||last-name-2^first-name-2||19580801000000|F
O|1|A997777||^^^RqL_Std1||20170220170000
R|1|...
...
O|2|A997777||^^^RqL_Std2||20170220170000
R|1|...
...
O|3|A997777||^^^RqL_Std1||20170220170000
R|1|...
...
L|1|N

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1.2.2 Other interfaces
RQL-471 - CSV import interface
Test requests can be imported from a CSV file. The columns are separated by tabs. The following table lists the
possible fields.

The following rules must be observed:


• Every row of the file must contain a single test request.
• Every row must end with a carriage return (<CR>) and a line feed (<LF>) character.
• Every column is separated from the next by a tab character (<TAB>).
• The laboratory ID and the test designation must always be provided as the minimum information.
• The fields listed in the table can be left off starting from the back.
• When specifying dates, it must be ensured that the correct date format is used. The system date
format configured in Windows must always be used.

Item Description Data type Width

1 Lab ID character 20

2 Test designation character 21

3 Patient last name character 25

4 Patient first name character 25

5 Patient date of birth date

Example:
The example shows the importing of multiple test requests. Multiple different tests are requested for the Lab
ID “Lab 116”. The delimiter is entered as <TAB>. The end of a row is indicated with <CR><LF>.

Lab100<TAB>Standard 1<TAB>Mustermann<TAB>Peter<CR><LF>
Lab10<TAB>Standard 2<TAB>Musterfrau<TAB>Eva<TAB>05.06.1999<CR><LF>
Lab103<TAB>Standard 3<TAB>Zocker<TAB>Elvira<TAB>01.01.2011<CR><LF>
Lab104<TAB>Standard 4<TAB>Müller<TAB>Heinz<TAB>11.11.1911<CR><LF>
Lab105<TAB>Standard 1<TAB>Mayer<TAB>Karl<TAB>18.02.2000<CR><LF>
Lab106<TAB>Standard 1<TAB>Zocker<TAB>Gerd<TAB>23.05.1950<CR><LF>
Lab107<TAB>Standard 3<TAB>Staup<TAB>Fritz<TAB>01.03.1900<CR><LF>
Lab108<TAB>Standard 2<TAB>Zocker<CR><LF>
Lab109<TAB>Standard 2<TAB>Mustermann<CR><LF>
Lab110<TAB>Standard 2<TAB>Mustermann<TAB>Tinchen<CR><LF>
Lab111<TAB>Standard 3<CR><LF>
Lab112<TAB>Standard 4<CR><LF>
Lab113<TAB>Standard 3<CR><LF>
Lab114<TAB>Standard 4<CR><LF>
Lab115<TAB>Standard 3<CR><LF>
Lab 116<TAB>Standard 1<CR><LF>
Lab 116<TAB>Standard 2<CR><LF>
Lab 116<TAB>Standard 3<CR><LF>

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Lab 116<TAB>Standard 4<CR><LF>
Lab117<TAB>Standard 1<CR><LF>

RQL-474 - XML result export


The result of a test request can be exported to XML format for post-processing by a third-party system. The
table lists the exported fields.

Field Description XML Width


name type

LabId Lab ID of the test request String 20

Code Allergen code String 5

Intens Measured intensity R8

Units Calculated units R8

Rast Calculated RAST class R8

Example:
The example shows a result export from a test strip with 20 allergens.
<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<DATAPACKET Version="2.0">
<METADATA>
<FIELDS>
<FIELD attrname="LabId" fieldtype="string" WIDTH="20"/>
<FIELD attrname="Code" fieldtype="string" WIDTH="5"/>
<FIELD attrname="Intens" fieldtype="r8"/>
<FIELD attrname="Units" fieldtype="r8"/>
<FIELD attrname="Rast" fieldtype="r8"/>
</FIELDS>
<PARAMS/>
</METADATA>
<ROWDATA>
<ROW LabId="ÜP AK 13354 pos2" Code="D1" Intens="203." Units="19.31" Rast="4."/>
<ROW LabId="ÜP AK 13354 pos2" Code="D2" Intens="201." Units="18.4" Rast="4."/>
<ROW LabId="ÜP AK 13354 pos2" Code="T2" Intens="79." Units="0.94" Rast="2."/>

</ROWDATA>
</DATAPACKET>

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RQL-476 - Result to clipboard
There are two options for exporting results to the clipboard:

• Results data incl. standards and the Lab ID (1 - standard)


Exports Lab ID and code and RAST value for each allergen one time. The sequence of the output
matches the order of the allergens on the test strip.
Example:
AK 12345 pos2
D1;0.1
D2;0.5
...
Here, the Lab ID is AK 12345 pos2. The subsequent rows list the allergy code and RAST class for each
allergen contained on the test strip. The RAST class is indicated with one decimal place. The decimal
separator comes from the Windows setting.
• Results data incl. standards (2)
Exports the RAST value for all allergens and the intensity for the standards (5 to 1). No allergen code is
given. The sequence of the output matches the order of the standards/allergens on the test strip.
Example:
84
72
45
26
15
0.1
0.5
...
The intensity of the standards (first 5 values) and the RAST classes are indicated with one decimal
place. The RAST class for each allergen on the test strip is identified. The decimal separator comes
from the Windows setting.
The entry
[Settings]
ClipboardExport=x
in the configuration file determines the selection. x stands for the number of the export option specified above.

1.2.3 Support interfaces


RQL-473 - Saving the measured image
The scanned image can be saved to a JPEG file after the measurement. The saved image can be read with RIDA
®
qLine Soft and analyzed.

RQL-478 - Export/import test request


®
This is used to export a measured test request and import it to another RIDA qLine Soft system. The data is
exchanged via an XML file with the following structure:

16 RIDA qLine® Soft – Interface Description 2017-06-28


Field Description XML type Width
name

ID Unique ID of the test request from the exporting system I4

Date Date on which the test request was entered. DateTime

LabId Lab ID of the test request. String.uni 40

TestId Unique ID of the test strip. I4

Status Status of the test request I4

Color Color of the test strip (RGB value). I4

Device Device used to perform the measurement. I4

Image Scanned image Bin.hex


Binary

Tab Image of the test strip tab. Bin.hex


Binary

YStart Y start position. I4

Gradient Gradient if the test strip is not perpendicular. I8

Surface Gray values for all positions of the analyzed strip. Bin.hex
These values are shown in the 3D representation. Binary
The values are stored in a stream, in which the X and Y
coordinates and then the associated measurement
value are saved as integers.

Intens Intensity values for all positions of the analyzed strip. Bin.hex
These values are shown in the line representation. Binary
The values are stored in a stream, in which the X
coordinate and the measurement value for this point
are stored as integers.

TestName Designation of the test strip. string.uni 42

The analyzed and calculated results are not exported. Only XML result export can be used for this purpose.

17 RIDA qLine® Soft – Interface Description 2017-06-28


Example:
<?xml version="1.0" standalone="true"?>
<DATAPACKET Version="2.0">
<METADATA>
<FIELDS>
<FIELD fieldtype="i4" attrname="ID"/>
<FIELD fieldtype="dateTime" attrname="Datum"/>
<FIELD fieldtype="string.uni" attrname="LabId" WIDTH="40"/>
<FIELD fieldtype="i4" attrname="TestId"/>
<FIELD fieldtype="i4" attrname="Status"/>
<FIELD fieldtype="i4" attrname="Farbe"/>
<FIELD fieldtype="i4" attrname="Device"/>
<FIELD fieldtype="bin.hex" attrname="Bild" WIDTH="1" SUBTYPE="Binary"/>
<FIELD fieldtype="bin.hex" attrname="Lasche" WIDTH="1" SUBTYPE="Binary"/>
<FIELD fieldtype="i4" attrname="YStart"/>
<FIELD fieldtype="r8" attrname="Anstieg"/>
<FIELD fieldtype="bin.hex" attrname="Surface" WIDTH="1" SUBTYPE="Binary"/>
<FIELD fieldtype="bin.hex" attrname="Intens" WIDTH="1" SUBTYPE="Binary"/>
<FIELD fieldtype="string.uni" attrname="TestName" WIDTH="42"/>
</FIELDS>
<PARAMS/>
</METADATA>
<ROWDATA>
<ROW TestName="Standard 3"
Intens="AAAAAAEAAAABAAAAAQAAAAIAAAABAAAAAwA …"
Surface=" ="CgAAADsAAAAIAAAACgAAADo …"
Anstieg="-5.076142027974129e-003"
YStart="15"
Lasche="SkZJRgAAAABvDwAA/9j/4AAQSkZJRgABAQEBLAEsAAD …"
Bild="iVBORw0KGgoAAAANSUhEUgAAAk8AAAAbCAIAAADqJfzxAAAABmJLR0QAAAAAAAD5 …"
Device="0"
Farbe="5989120"
Status="6"
TestId="15"
LabId="#13194 QK2 neg."
Datum="20140702T15:03:27070"
ID="944"/>
</ROWDATA>
</DATAPACKET>

18 RIDA qLine® Soft – Interface Description 2017-06-28


2 Deployment description
RQL-518 - Installation overview
The software is operated as a fully traditional single workplace installation as well as in a network.

• Single workplace installation


The full system is installed on a single computer.

• Network installation
The installation can be distributed across multiple workplaces.

The installation routines take care of automatic updates once the software has been installed. For seamless
updates, all program modules must be furnished with a unique version number.

Older versions of the software cannot be installed over an existing new version.

The installation routines can be invoked via parameters to allow for completely automatic installation requiring
no further user interaction.

RQL-493 - Single workplace installation


®
In single workplace installation, all components of RIDA qLine Soft are installed on a single computer. The
measurement device is also connected to this computer. Either the RIDA qLine Scan or the Epson Perfection is
used.

The connection from the LIS is optional. The LIS server and its services are available on the network.

Workstation PC

Flatbed scanner
Epson perfection

Figure 10 Single workplace installation

19 RIDA qLine® Soft – Interface Description 2017-06-28


RQL-494 - Network installation
In a network installation, the system can be made up of multiple computers. The database must be centrally
stored on a file server. All connected clients require read and write access to the database directory and all the
files it contains.

The driver for the measurement device only has to be installed on the measurement computer. For the sake of
®
simplicity, only the RIDA qLine Scan is shown in the graphic. Multiple measurement computers can be set up in
the system. They can also operate different measurement devices.

®
Only RIDA qLine Soft need be installed on the workplace computers where findings are evaluated;
measurement device drivers need not be installed. In this way, multiple computers can be set up in the system.

If an LIS is connected, the system must have a computer with the configured RLink software. The connection to
®
the LIS is configured on this computer (IP address and LIS port must be known). All RIDA qLine Soft workplaces
involved in generating work lists and findings (returning results to the LIS) must have a configured connection
to the RLink computer. For this purpose, the IP address and the port on which the RLink interface works must
be known.

Measuring PC

Workstation PC

RLink PC

Figure 11 Network installation

20 RIDA qLine® Soft – Interface Description 2017-06-28

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