HSB HR HS 005 Version 2 Page 1 of 13

HUMAN SERVICE BULLETIN

HumaReader HS 005

Subject Software Release 5.4 in English, Russian, Spanish and French

New Settings 1.2
Issue date 2018/01/04
Author Stan Günther / Johannes Hüttinger
Instrument(s) HumaReader HS
Serial number range:  usable for all Instruments with SD/USB platform before SN
451592
Implementation  immediately
 next service
 upon problem occurrence
 information
Part(s) recall  yes
 no
 not applicable

Brief description

We would like to inform you about the release of Software V5.4 in English, Russian, Spanish and French.
We are also happy to offer you the new revision of the User Manual (Rev. 09) as well as the Settings V1.2.

The new software 5.4 is available for all instruments before. 4581592.

The major improvements are:

- Out of calibration curve Calculation
- Optimized 4PL algorithm
- Preset - Save and Load Well definitions
- Multiple controls
- French User Software

For installation instructions refer to chapter A

For further details of changes see chapter B

Please update your installed base with the next service

With the new settings we have also implemented a ”Program” named “.Setting 1.2”.
This will help to ensure that the update was completed successfully.

Details of these settings can be found in chapter B, ‘Change Details or in the ‘Readme’ file that is
included to the installation file.

Please inform your customers about these changes.

The latest manual and quick guide are available in the Download Finder in the login area of HUMAN’s
website.

Please update your Instruments according to the instructions.

The latest application settings files and software build can be found on the HUMAN website after login.
http://login.human.de/en/service/Technical_Downloads/Instruments/HumaReaderHS.php
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Chapter A

Installation procedure –HFSE board software 5.4

Please ensure that all HumaReader HS instruments with serial number lower than 501106015 HFSE are
using operating system WinCE version 1.4!

WARNING: All sample data and applications will be deleted by this update, due to a database change.
Please print out NON Human- and changed applications in order to reprogram those applications after
the software update.

Necessary tools

 SD memory card (included to 16670/75 WinCE Upgrade Kit‘) or USB flash drive pen
 USB Mouse

Instruction

1. Save the system software RT2100.exe to your SD card or USB flash drive

Note: It is recommended to use an SD card to perform the upgrade;

Do not change the software name ‘RT2100.exe’; otherwise the system can’t recognize the software.

2. Out of the settings file V1.2 copy and paste the database global.dat to your SD card or USB flash
drive.
This will be continued in step 33 here in this HSB.

3. Insert the USB flash drive or SD card into the appropriate port/slot on the back of the instrument,
connect a USB mouse and turn the instrument on!

4. Enter the Manufacturer menu by pressing the left mouse several times on the top right corner of the
main menu.
Type in the password (human1).

Click here
several
times. PW:
human1
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5. In manufacturer settings, select Explorer to open the WindowCE interface.

6. Select Exit to close the window and return to the main menu.
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7. Click Power Off and close the current operating software.

Note: The operating software needs to be closed first. Otherwise the installation will fail.

8. A new Window opens. Click the right mouse on the blank frame and confirm to power off the system
by pressing YES.

9. Double click on My Computer

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Note:
If the USB flash drive is not detected, the folder ‘Hard Disk’ will not be displayed in ‘My computer’
In this case, insert the USB flash drive into the second USB port. If the flash drive is still not detected, use an
SD card instead. Then look for the folder ‘Storage Card’.

10. Open the folder Storage Card or Hard Disk and make a Copy of the software file ‘RT2100’

11. Go back to “Resident Flash” folder, select all files inside and Delete them!

12. The following warnings will appear. Confirm the process twice by pressing Yes and Yes to all.
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13. Now that the folder is empty, click the right mouse and Paste HumaReader HS software ‘RT2100’.
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14. Close Resident Flash folder and go back to the main menu.
15. Click Start and Suspend to close the operating system WindowsCE. The screen becomes blue.
16. Switch off the instrument immediately.

17. Wait 2 minutes before turning on again.

18. With the next start up click on HUMAN in main screen and make sure software version 5.4e has
been installed!

19. Enter the Backdoor again see step 3

20. Click Flash user area (to clean up patient results)
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21. Select, ‘History plate data’ and press clear

22. Also clear “History patient data” and “History sample data”.
23. Exit User area.

24. Select Item reset

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25. Say Yes to reset all items (now all new features will be available)

26. Click on User parm to enter Serial Number, click the ID setting

27. Enter the Serial Number from the label on the back of the Instrument and press OK
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28. Click on Exit to leave User Param

29. Click on Exit to finish the update

30. Enter System menu

31. Enter Touch Panel to re calibrate touch screen and follow the commands on the display. Confirm by
pressing Yes
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32. Press Import

33. Press Import Programs depending to the memory device (SD card or USB flash drive)
Now the database global.dat will be imported as mentioned in step 2.

34. Press OK to leave import

35. Enter the hospital name for future print outs.
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36. Press Exit to leave to main menu

37. Enter Programs to ensure the import process was done properly and >Rev 1.2 Setting< is shown at
position 001 under ‘Program’

38. Press Exit finish update

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Chapter B - Change Details:

Software 5.4

1. Out of calibration curve Calculation - See user manual chapter 9.1

a. If a results is outside of the calibration curve the instrument calculates the result by
interpolation, if possible
b. if this is not possible, it will show higher or lower that the value of the highest/lowest
calibrator with three options

c. On value (Default) it will show the value flagged with an * to claim out of calibration
limits - if a positive/negative threshold is set, also this is shown correctly

d. On Sx it will show on higher or lower than the highest and lowest standard and flag
with an * if a positive/negative threshold is set also this is shown correctly

e. Off - No value will be shown only XX flagged with an * to claim out of calibration
limits - Also no positive or negative will be claimed

2. Preset - Save and Load Well definitions – See user manual Chapter 6.6
a. Save 6 presets of a well definition

3. Multiple controls – see user manual chapter 5.2.1 and 5.2.2

a. User can make 3 repetitions from one control e.g. NC1, NC1, NC1
b. Number of controls can vary independent in program e.g. 2xNC and 3x PC

Setting Release 1.2

Details of the settings release:

New application (Name – REF):

-Vitamin D - 55500
-anti HCV - 51250
-Rubella IgG Quant - 51208

Updated application:
- All Application have a Preset for the Controls

Modified acc. latest leaflet – Cut Off & validation criteria

- Rubella IgM µ Capture - 51108
- HIV - 51215 – valid from lot 16502

Validation Criteria adjusted acc. Leaflet

- TSH - 54030
- Testosteron - 55010
- T3 - 54010
- T4 - 54020

Set Cubic spline to 4PL algorithm

- Cardiolipin-Antibodies IgG - 59082
- Liver Screen - 66005
- TPO-Antibodies - 85020
- Gliadin-Antibodies IgA - 30600

Name corrected from IgG to IgA

-Salmonella-Antibodies IgA (cut-off) -40050

Blank Value corrected

- t-Transgultaminase-Antibodies IgA - 30405

Deleted:
-ß-Lactoglobulin-Antibodies - 59350