HumaClot Pro

| LIS Interface Manual

Version 6

Revision list
Revision Date Description Editor
1 2015/03/18 First revision Mathias Kamprath
2 2017/10/19 Review of "4. Preparation of Host computer" Mathias Kamprath
3 2018/01/10 Correction step 11 in "4. Preparation of Host computer" Mathias Kamprath
4 2018/05/28 Description of test request file added Mathias Kamprath
5 2018/05/28 Example of result file added Mathias Kamprath
6 2018/06/21 Review of result file chapter Mathias Kamprath
HumaClot Pro – LIS Interface Manual Version 6 Page 2 of 16

Contents
1. General ...................................................................................................................................................... 3
2. Operation................................................................................................................................................... 3
2.1. Get a request ......................................................................................................................................... 3
2.2. Resend results ....................................................................................................................................... 4
3. Setup .......................................................................................................................................................... 4
3.1. General .................................................................................................................................................. 4
3.2. LAN button menu .................................................................................................................................. 4
3.3. Host button menu ................................................................................................................................. 5
3.3.1. IP addresses ....................................................................................................................................... 5
3.3.2. Account .............................................................................................................................................. 5
3.3.3. Requests deleted by .......................................................................................................................... 5
3.3.4. Bidirectional....................................................................................................................................... 5
3.3.5. Test it ................................................................................................................................................. 5
3.3.6. Show log ............................................................................................................................................ 5
3.3.7. Init log ................................................................................................................................................ 6
3.3.8. Tools .................................................................................................................................................. 6
3.3.9. Save & Exit ......................................................................................................................................... 6
4. Preparation of Host computer................................................................................................................... 6
5. Workflow of bidirectional Host communication ....................................................................................... 9
6. Procedure to generate a job list at the analyzer ..................................................................................... 11
7. Assigning tests manually (bidirectional Host connection deactivated) .................................................. 11
8. Assigning tests to each sample individually by use of Host communication (bidirectional Host
connection activated) ...................................................................................................................................... 11
9. Tests with valid Host ID can be assigned only when all conditions for performing the measurement on
the analyzer are correct .................................................................................................................................. 11
10. Test request file ................................................................................................................................... 12
11. Result file ............................................................................................................................................. 12
HumaClot Pro – LIS Interface Manual Version 6 Page 3 of 16

1. General
The analyzer is equipped with a Local Area Network (LAN) interface (RJ-45 socket) on the rear side of the analyzer which is
supposed to be used for connecting external Personal Computer (PC) and Laboratory Information System (LIS) systems for
data transfer.

The LAN interface can be used as follows:

Uni-Directional: To transfer analyzer parameters and patient results to a connected PC or LIS System.
Bi-Directional: To receive sample job lists from an LIS and to transfer patient results and analyzer parameters to a
connected LIS or PC.

2. Operation
2.1. Get a request
The Tools menu in the Load Samples & STAT menu offers the Get Request button to verify whether there is a sample
request provided by a connected LIS. (This function is only available with bi-directional LIS software.)
HumaClot Pro – LIS Interface Manual Version 6 Page 4 of 16

2.2. Resend results

The short form Results lists offer the Resend button to send results to LIS software a second time. (This is only possible
with an active connection to LIS software.)

3. Setup
3.1. General
The settings for LAN and LIS (Host) can be done in the Service menu in the Data section.

3.2. LAN button menu

The analyzer is equipped with a 100 MBit LAN port (see “1. General”). The LAN connection is used for the uni- or bi-
directional Host communication to access the hospital LIS system.

The DISCONNECT button is displayed if the LAN connection is already established. An existing LAN connection will be
disconnected if this button is clicked.
HumaClot Pro – LIS Interface Manual Version 6 Page 5 of 16

The CONNECT button is displayed if LAN connection is not present and will connect the analyzer to LAN if clicked.

Select QUIT button to leave this menu.

3.3. Host button menu

3.3.1. IP addresses

To enter IP addresses for analyzer, net mask, host and gateway.

3.3.2. Account

To enter user name and password for host communication. (Maximum length is 15 alphanumeric characters.)

3.3.3. Requests deleted by

If ANALYZER is selected test request files are automatically erased at the host after the corresponding result file is
available.

3.3.4. Bidirectional

If selected the analyzer software searches for test request files in the released host network folder.

3.3.5. Test it

Click to test the bidirectional host communication by writing, reading and deleting several test files in the host directory.

3.3.6. Show log

Click to display the current log file.

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3.3.7. Init log

Click to create a new log file.

3.3.8. Tools

Click to open a new dialog to get a hardcopy of the screen content.

3.3.9. Save & Exit

Click to store the host settings and to close the Host button menu.

4. Preparation of Host computer

This section describes the bidirectional Host communication of the analyzer. The data interchange is taking place via
file transfer.
Follow the step by step instruction below to install setup and test the FTP server access for the analyzer.

1. Connect the analyzer to the Host computer with a crossover network cable (no patch cable).
2. Setup a fixed IP address on the Host computer, e. g. 192.168.077.118.
3. Create a folder (e. g. "BidiHost") and release it for everybody with full read/write/delete access.
4. Download the free Filezilla-FTP-Server software for Windows: http://filezilla-project.org/.
5. Install the downloaded EXE-File. All settings as default. Filezilla is now installed and the interface is active.
6. In the FileZilla Server Interface select USERS (1) in the menu EDIT or select the USER symbol.
7. Click on the ADD button (2) on the right side and enter an account name, e. g. "bidihostuser" (3).
Confirm with OK button.
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8. In the center activate the checkbox "Password" and enter the password, e. g. "hostcom".

9. Click on "Shared folders" on the left side, next select the "Add" button in the center.
10. Select the network folder "HostCom" to enable access to this folder for the analyzer.

11. In the center check all checkboxes for "Files" and "Directories" and click on "Set as home dir".

12. Close the "Users" dialogue with "OK" button

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13. Windows-Firewall settings:

Allow the program "FileZillaServer.exe" access through the firewall.
14. At the analyzer LCD enter the service password and select SETUP\SERVICE\HOST.

15. In the analyzer Host interface enter the following parameters (example):
IP address analyzer: 192.168.077.007
Netmask: 255.255.255.000
IP address HOST: 192.168.077.118
IP address gateway: 192.168.077.118 (example if no gateway is used)
Username: bidihostuser (max. 15 alphanumeric characters)
password: hostcom (max. 15 alphanumeric characters)
16. Select SAVE&EXIT to store the settings.

17. Restart the analyzer. The file transfer directory "cl1k_v2<mainboard-id>" is created during the startup of the analyzer.
<mainboard-id> is a unique number of the analyzer main board and will allow using more than one analyzer in the same
network and with the same shared folder.
18. Enter the service password.

19. Select SETUP\SERVICE\HOST.

20. Select the "Test it" button to check the communication to the host.
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5. Workflow of bidirectional Host communication

Test Request file written by

host
(tr_sample-ID_test-
abbre_xxxx) into Host
directory

Analyzer reads Host directory

for tr-files when entering
LOAD SAMPLES menu.
When scanning sample-IDs
and when manually entering
sample-IDs tests are
assigned

No

tr-file for
sample-ID
1...25 found?

Yes

Assign Test to sample

Open test Display corresponding

requests Yes message and write open test
available? request into log-file

No

Measure and create re-file for

each tr-file in host directory

Requests
deleted by Analyzer deletes
Yes
Analyzer corresponding tr-file
selected?

No

Host reads re--file

Host deletes corresponding

Host reads re--file
tr-file

End
HumaClot Pro – LIS Interface Manual Version 6 Page 10 of 16

 During the start of the analyzer an export file is created which contains the abbreviations of all up to 50 tests
existing in the analyzer parameters. This list can be used by the Host to synchronize the test abbreviations
between analyzer and Host. The file name of this list is "test_abbrev.txt" and it is located in the folder "Host"
which is a subfolder of the shared network folder.
 A unique test request file (tr_-file) must be generated by the Host for each measurement. The filename is
"tr_<sample-id>_<test-abrev>".
 A tr_file does not contain any data all information is coded in the file name.
 The analyzer reads these tr_files and generates the job list in the LOAD SAMPLES menu.
 It is possible to assign or un-assign test requests manually, also in bidirectional host communication mode.
 When selecting LOAD SAMPLES in bidirectional host communication mode the analyzer reads the tr_files.
 After finishing the measurement the analyzer creates a re_file, containing the results of the measurement.
The re_file format is "re_<sample-id>_<test-bbrev>_xxxx.csv".
xxxx is a ring number starting with 0000. This ring number is automatically increased by the analyzer software for
each new result. This avoids overwriting of repeated measurement results.
 If the radio-button "REQUESTS DELETED…" is set to "BY ANALYZER", the corresponding tr_file is removed by the
analyzer. If "BY HOST" is selected, tr_files have to be removed by the Host.
 If tr_files are not removed after the corresponding measurement is finished, the analyzer will do the same
measurements again.
 The Host must allow the analyzer to read, write and to create folders. If the radio-button "REQUESTS DELETED…"
is set to "BY ANALYZER" the Host must also allow the analyzer to remove files. A re_file contains the same data as
in unidirectional host mode.
 Tr_files and re_files contain Sample ID and test abbreviation in their file name, e.g. "tr_<sample-id>_<test-
abbrev>" and "re_<sample-id>_<test-abrev>_xxxx.csv".

Please note:
Scanned Sample IDs may contain special characters. Nevertheless the software reacts safe if not allowed special
characters are in the Patient ID string. Therefore Sample ID and test abbreviation may only consist of standard US
ASCII alphanumeric characters. Some special characters are allowed. Sample IDs and test abbreviations are checked
after entering. If forbidden characters are used a corresponding message is displayed.

The following characters are allowed for the Sample ID:

ABCDEFGHIJKLMNOPQRSTUVWXYZ
abcdefghijklmnopqrstuvwxyz
0123456789
!&()[]{}=#~+-,^@

In case of any error flags the Host can decide to create a new tr_file to repeat the measurement. The analyzer does
not react on error flags.
For manually assigned tests without Host request the re_file is written also. The host can decide to read these files
and/or erase them.
Control measurements will always be loaded manually and cannot be initiated by the host since controls are not
patients.
The Button "Resend Results" is placed in the menu SHORTFORM RESULTS OF THE LAST RUN, accessible by the button
"RESULTS" in the main menu. The analyzer tries to reconnect to the Host if the Connection is closed before resending
the results to the host.
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6. Procedure to generate a job list at the analyzer

A test can be assigned to a sample in two different ways if bidirectional Host connection is activated. In both cases the
software searches for all tr_files on entry to this menu.

7. Assigning tests manually (bidirectional Host connection deactivated)

Tests can be assigned to samples by use of the sample buttons. Only tests that are already loaded to the system can
be assigned. The volume of the test reagents are known to the software. Each assign of a test to a sample subtracts
the required liquid amount from the reagent. It is not possible to assign any more tests to samples when the volume
of the reagent has reached rest volume.

8. Assigning tests to each sample individually by use of Host

communication (bidirectional Host connection activated)
When the load-samples-menu is entered, the software searches in the Host-directory for tr_files. A corresponding
message is displayed.
The user scans a sample by use of the external handheld barcode scanner, attached to the analyzer or by use of the
internal barcode scanner. With each scan the analyzer searches for the corresponding tr_file that has already been
read in. Test requests will automatically be assigned to samples.
The tools-menu has a button GET TEST REQUEST which initiates a new search for tr_files in the Host-directory. This
does the same as if leaving and re-entering the LOAD SAMPLES menu.
If a barcode is not readable the user can enter the sample ID manually and select the sample. In this case the analyzer
works like the barcode has been scanned.
When Host is in bidirectional mode, the next sample button is automatically selected, after a sample ID has been
entered (manually or by scan). In unidirectional mode the next sample button is not selected automatically, so the
user is able to assign tests manually.

9. Tests with valid Host ID can be assigned only when all conditions for
performing the measurement on the analyzer are correct
Software reaction in case of invalid conditions for test assignment:
After entering (manually or by scanner) a sample-ID the analyzer immediately checks:
 Required test is loaded?
 Test reagents are loaded?
 Test is calibrated?
 Test reagents have enough liquid?
 Test reagents are not expired?
 Washer is loaded?
HumaClot Pro – LIS Interface Manual Version 6 Page 12 of 16

10. Test request file

A unique test request file (tr_-file) must be generated by the Host for each measurement.
The syntax of the test request file is as follows:

tr_<sample-id>_<test-abbrev>

A tr_file does not contain any data. All information is coded in the file name, e.g.:

tr-file Description
tr_Patient01_PT-SI Test request file for the sample ID "Patient01" and the test abbreviation "PT-SI"
tr_sample01_PT-SI Test request file for the sample ID "sample01" and the test abbreviation "PT-SI"
tr_12345_aPTT Test request file for the sample ID "12345" and the test abbreviation "aPTT"

The analyzer reads these tr_files and generates the job list in the LOAD SAMPLES menu.

11. Result file

The result file for a sample is generated by the analyzer and is written to the shared network folder at the Host.
Part of the result file name is the sample ID and the test abbreviation.
The syntax of the result file is as follows:

re_<sample-id>_<test-abbrev>_xxxx.csv

The result files are written into the folder "host_<IP-address>" which will be created automatically by the analyzer
software.
Each result file has a unique name and cannot be overwritten by the analyzer.
Each result of a measurement is written into one separate result file.
The result file can be read and then erased by the host.
Result files cannot be erased by the analyzer, only test request files can be erased by the Analyzer.
HumaClot Pro – LIS Interface Manual Version 6 Page 13 of 16

st
If "1 evaluation only" is selected in the test setup the result file has the following content:

Item Description Example

START Indicator for start of information START
sample_name Sample-ID sample01
sample_no 1 … 25 for the 25 sample positions 1
method_abbrev Test name abbreviation of test setup PT-SI
cuvette_no 0 … 31 for the cuvette which is used for measurement 4
channel_no 0 for left photometer channel 1
1 for right photometer channel
lamevi_file For manufacturer only cl180621/mb2b6792.lmv
State OK No problems OK
D Too high deviation in between sub determinations of a multiple
determination result
L Liquid problem with washer, reagent or sample
F Photometer problem
M Photometer mixer problem
S Reagent stirrer problem
Q QC problem (e. g. missing or bad control measurement for a test
which is under QC)
T Temperature problem with pipettor or measuring rotor
date_time Date in "dd,mm,yy" format ";" time in "hh,mm,ss" format 21,06,2018;10:53:33
clot Raw value in seconds 12,6 s
st
clot-conv1 1 clotting conversion (%, mg/dl, …) 1,1549
nd
clot-conv2 2 clotting conversion (INR or ISI) 0,95 INR
END Indicator for end of information END

Example:

re_sample01_PT-SI_0000.csv
START;;<CR><LF>
sample_name ;sample01;<CR><LF>
sample_no ;1;<CR><LF>
method_abbrev;PT-SI;<CR><LF>
cuvette_no ;4;<CR><LF>
channel_no ;1;<CR><LF>
lamevi_file ;cl180621/mb2b6792.lmv;<CR><LF>
State:ok;;<CR><LF>
date_time;21,06,2018;10:53:33<CR><LF>
clot ;= 12,6 s;<CR><LF>
clot-conv1;1,1549;<CR><LF>
clot-conv2;= 0,95 INR;<CR><LF>
END;;<CR><LF>
HumaClot Pro – LIS Interface Manual Version 6 Page 14 of 16

nd
If "2 evaluation DIFFERENCE" also is selected in the test setup the result file has the following two additional items:

Item Description Example

START Indicator for start of information START
sample_name Sample-ID sample01
sample_no 1 … 25 for the 25 sample positions 1
method_abbrev Test name abbreviation of test setup PT-SI
cuvette_no 0 … 31 for the cuvette which is used for measurement 5
channel_no 0 for left photometer channel 1
1 for right photometer channel
lamevi_file For manufacturer only cl180621/mb2b6cfc.lmv
State OK No problems OK
D Too high deviation in between sub determinations of a multiple
determination result
L Liquid problem with washer, reagent or sample
F Photometer problem
M Photometer mixer problem
S Reagent stirrer problem
Q QC problem (e. g. missing or bad control measurement for a test
which is under QC)
T Temperature problem with pipettor or measuring rotor
date_time Date in "dd,mm,yy" format ";" time in "hh,mm,ss" format 21,06,2018;11:16:39
clot Raw value in seconds 18,0 s
st
clot-conv1 1 clotting conversion (%, mg/dl, …) 0,4553
nd
clot-conv2 2 clotting conversion (INR or ISI) 1,36 INR
grad/diff Difference in milli extinction 103,4 mE
kin-konv Converted value in [unit] by use of second calibration graph. The [unit] 103 mg/dl
of the converted value is set in the calibration menu of the analyzer.
END Indicator for end of information END

Example:

re_sample01_PT-SI_0001.csv
START;;<CR><LF>
sample_name ;sample01;<CR><LF>
sample_no ;1;<CR><LF>
method_abbrev;PT-SI;<CR><LF>
cuvette_no ;5;<CR><LF>
channel_no ;1;<CR><LF>
lamevi_file ;cl180621/mb2b6cfc.lmv;<CR><LF>
State:ok;;<CR><LF>
date_time;21,06,2018;11:16:39<CR><LF>
clot ;= 18,0 s;<CR><LF>
clot-conv1;0,4553;<CR><LF>
clot-conv2;= 1,36 INR;<CR><LF>
grad/diff ;= 103,4 mE;<CR><LF>
kin-conv ;= 103 mg/dl;<CR><LF>
END;;<CR><LF>
HumaClot Pro – LIS Interface Manual Version 6 Page 15 of 16

nd
If "2 evaluation KINETIC" also is selected in the test setup the result file has the following three additional items:

Item Description Example

START Indicator for start of information START
sample_name Sample-ID sample01
sample_no 1 … 25 for the 25 sample positions 1
method_abbrev Test name abbreviation of test setup PT-SI
cuvette_no 0 … 31 for the cuvette which is used for measurement 7
channel_no 0 for left photometer channel 1
1 for right photometer channel
lamevi_file For manufacturer only cl180621/mb2b71de.lmv
State OK No problems OK
D Too high deviation in between sub determinations of a multiple
determination result
L Liquid problem with washer, reagent or sample
F Photometer problem
M Photometer mixer problem
S Reagent stirrer problem
Q QC problem (e. g. missing or bad control measurement for a test
which is under QC)
T Temperature problem with pipettor or measuring rotor
date_time Date in "dd,mm,yy" format ";" time in "hh,mm,ss" format 21,06,2018;11:37:29
clot Raw value in seconds 21,0 s
st
clot-conv1 1 clotting conversion (%, mg/dl, …) 34,37 %
nd
clot-conv2 2 clotting conversion (INR or ISI) 1,58 INR
grad/diff Kinetic raw value in milli extinction per minute [mE/min] 106,7 mE/min
korrel Coefficient of correlation for linearity check 0, 781
kin-konv Converted value in [unit] by use of second calibration graph. The 107 mg/dl
[unit] of the converted value is set in the calibration menu of the
analyzer.
END Indicator for end of information END

Example:

re_sample01_PT-SI_0003.csv
START;;<CR><LF>
sample_name ;sample01;<CR><LF>
sample_no ;1;<CR><LF>
method_abbrev;PT-SI;<CR><LF>
cuvette_no ;7;<CR><LF>
channel_no ;1;<CR><LF>
lamevi_file ;cl180621/mb2b71de.lmv;<CR><LF>
State:ok;;<CR><LF>
date_time;21,06,2018;11:37:29<CR><LF>
clot ;= 21,0 s;<CR><LF>
clot-conv1; 34,37 %;<CR><LF>
clot-conv2;= 1,58 INR;<CR><LF>
grad/diff ;= 106,7 mE/min;<CR><LF>
korrel ;= 0,781;
kin-conv ;= 107 mg/dl;<CR><LF>
END;;<CR><LF>
HumaClot Pro – LIS Interface Manual Version 6 Page 16 of 16

nd ST st
If "2 evaluation 1 DERIVATION" is selected (1 Evaluation must be switched off in the test setup) the result file has
the following three additional items:

Item Description Example

START Indicator for start of information START
sample_name Sample-ID sample01
sample_no 1 … 25 for the 25 sample positions 1
method_abbrev Test name abbreviation of test setup PT-SI
cuvette_no 0 … 31 for the cuvette which is used for measurement 9
channel_no 0 for left photometer channel 1
1 for right photometer channel
lamevi_file For manufacturer only cl180621/mb2b74a0.lmv
State OK No problems OK
D Too high deviation in between sub determinations of a multiple
determination result
L Liquid problem with washer, reagent or sample
F Photometer problem
M Photometer mixer problem
S Reagent stirrer problem
Q QC problem (e. g. missing or bad control measurement for a test
which is under QC)
T Temperature problem with pipettor or measuring rotor
date_time Date in "dd,mm,yy" format ";" time in "hh,mm,ss" format 21,06,2018;11:49:15
grad/diff Maximum reaction curve slope in milli extinction per second [mE/s] 34,3 mE/s
st
(1 mathematical derivation)
max-time Time of the maximum reaction curve slope [s] 13,9 s
kin-konv Converted value in [unit] by use of second calibration graph. The [unit] of the 34 mg/dl
converted value is set in the calibration menu of the analyzer.
END Indicator for end of information END

Example:

re_sample01_PT-SI_0005.csv
START;;<CR><LF>
sample_name ;sample01;<CR><LF>
sample_no ;1;<CR><LF>
method_abbrev;PT-SI;<CR><LF>
cuvette_no ;9;<CR><LF>
channel_no ;1;<CR><LF>
lamevi_file ;cl180621/mb2b74a0.lmv;<CR><LF>
State:ok;;<CR><LF>
date_time;21,06,2018;11:49:15<CR><LF>
grad/diff ;= 34,3 mE/s;<CR><LF>
max-time ;= 13,9 s;
kin-conv ;= 34 mg/dl;<CR><LF>
END;;<CR><LF>