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HUMAN SERVICE BULLETIN

HumaStar 600 Software and Setting Update

Subject Software Update Version 2.5.0h and Setting Update Version 4.0
Issue date 31.08.2017
Author Silvia Fischer, Stefan Theimer
Instrument(s) HumaStar 600 (Ref 16660)
Serial number All
range From:
To:
Implementation Immediately
Next service
Upon problem occurrence
Information
Part(s) recall Yes
No
Not applicable

Brief description
In the end of August 2017 software version 2.5.0h will be available. The new software will include a lot of
new features as well as bug fixing. Together with the software we will issue a new setting database
version 4.0. The setting update is not compatible with the old software 1.9.0. It is mandatory to update the
software to 2.5.0h in order to use the new settings version 4.0.

A. Setting update
Compared to the previous database following settings have been changed:
alpha-AMYLASE liquicolor : Calibration stability 21 days
auto-BILIRUBIN-D liquicolor : Calibration stability 7 days; Concentration limit high 6.0 mg/dl
auto-CREATININE liquicolor : Calibration stability 7 days; Interfering method HbA1c-2
CHOLESTEROL liquicolor (LCF) : Concentration limit high 1100 mg/dl
CRP : Calibration stability 14 days
CYSTATIN-C liquidiret : Calibration stability 28 days
GLUCOSE Iiquicolor : Concentration limit low 2 mg/dl
GOT (ASAT) IFCC mod. liquiUV : Concentration limit high 600 U/l
HbA1c liquidirect : Concentration limit low/high 15/140 mmol/mol
HDL CHOLESTEROL liquicolor : Calibration stability 28 days; On board stability 25 days;
Concentration limit high 150 mg/dl
IMMUNOGLOBULIN IgA direct : Calibration stability 14 days
IMMUNOGLOBULIN IgM direct : Calibration stability 21 days
IRON TPTZ liquicolor : Calibration stability 14 days
LIPASE liquicolor : Concentration limit low 5 U/l
MICROALBUMIN : Calibration stability 30 days
TOTAL PROTEIN Iiquicolor : Calibration stability 28 days
UREA liquiUV : Calibration stability 14 days; Concentration limit high 350 mg/dl
URIC ACID liquicolorplus : Calibration stability 30 days; Concentration limit low 1 mg/dl
RHEUMATOID FACTORS : Calibration stability 21 days
Total Iron Binding Capacity : New calculated test

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B. New Features of SW version 2.5.0h

1. Methods:
a. Smaller Kit Sizes for Reagents available
For the following tests the setup in the Database is made
for two different kit sizes.
The kits will be available to order in the end of September 2017.
In the end of the year more tests will be added.

Description Name REF Tests/Kit Ref Tests/Kit


ALKALISCHE PHOSPATASE liquicolor (IFCC) APAMP 12117300 2 x 150 12117600 2 x 250
ALKALISCHE PHOSPATASE opt. liquicolor APDEA 12027300 2 x 150 12027600 2 x 250
alpha-AMYLASE liquicolor AMY 12028300 2 x 100 12028600 2 x 260
auto-BILIRUBIN-D liquicolor BILDA 10741300 2 x 100 10741600 2 x 210
auto-BILIRUBIN-T liquicolor BILTA 10742300 2 x 150 10742600 2 x 210
CALCIUM liquicolor CA 10011300 3 x 100 10011600 3 x 430
CHOLESTEROL liquicolor CHOL 10028300 2 x 100 10028600 2 x 150
auto-CREATININE liquicolor CREAA 10052300 2 x 150 10052600 2 x 250
CRP CRP 11241300 1 x 100 11241600 1 x 250
gamma-GT liquicolor GGT 12023300 2 x 100 12023600 2 x 250
GLUCOSE liquicolor GLU 10260300 2 x 150 10260600 2 x 210
GOT (ASAT) IFCC mod. liquiUV GOT 12021300 2 x 200 12021600 2 x 310
GPT (ALAT) IFCC mod. liquiUV GPT 12022300 2 x 200 12022600 2 x 310
HDL CHOLESTEROL liquicolor HDL 10084300 2 x 100 10084600 2 x 180
IMMUNOGLOBULIN direct IgA IGA 11501300 1 x 100 11501600 1 x 250
IMMUNOGLOBULIN direct IgG IGG 11502300 1 x 100 11502600 1 x 250
IMMUNOGLOBULIN direct IgM IGM 11503300 1 x 100 11503600 1 x 250
LDH SCE mod. liquiUV LDH 12014300 2 x 100 12014600 2 x 180
TOTAL PROTEIN liquicolor PROT 10570300 2 x 150 10570600 2 x 210
mono
TRIGLYCERIDE liquicolor TG 10724300 3 x 60 10724600 3 x 210
UREA liquiUV UREA 10521300 2 x 150 10521600 5 x 250
plus
URIC ACID liquicolor UA 10694300 2 x 100 10694600 5 x 250

b. Minimum reaction volume


The minimum dispensing volume to the cuvette (before the first reading) is decreased to 180 l.

c. Stability Time Display


The display of the stability time has changed from weeks to days (1 to 120) for following
functions:
- Onboard Stability
- Reagent Blank Stability
- calibration Stability

d. Units
The software allows the definition of a method without a Unit.

e. Predilution
The sample pre dilution can be applied to calibrator and QC

f. Calculated methods are now Open Methods

g. Negative Results display/report: If the lower concentration limit is set to zero and no repeat run
is activated, all negative results will reported as zero

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2. Units &Limits:
All function can be changed only by a SuperVisor. The changes are under their responsibility.
Open the menu methods>Units & Limits

a. Keep Using function for reagents:


The on board stability given from Human reagents can be extended, just tick the box for Keep
using.

b. Units conversion was renamed to Method Correlation.

c. The number of default replicas for the Reagent Blank can be changed.

3. QC Menu:
a. QC Statistic Levey Jennings graph display and printout:
- SD was added to the left axis and values/ unit was added to the right axis
- The In-Range (min/max) zone is displayed green
- CV is rounded with 2 decimal position
- results out of concentration validity limits are not taken into calculation of statistics or shown in
the graph
- Date and point number was added to the printout

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b. QC Done screen the option to delete QC results is removed

c. QC Set
- Lot number is mandatory
- Expected mean was added
- changes in limits are applied to already tun tests for the corresponding QC Set and Lot number
- Copy function was implemented to create a new Qc set using an existing set

d. New Statistic Menu was implemented


QC data can be displayed or printed for a special time period

4. Main Screen
a. Estimated time to finalize sample processing was added.

b. An Eventlog for the system and ISE are added to the main screen. The current operation status
will be displayed such as Initialization, Warming up, Tip cleaning, Cuvette Blank, Cuvette Check,
Cuvette Washing, Intensive Cuvette Cleaning, System Flush, Photometer Calibration Clot
Calibration and Intensive Washer Cleaning.

c. User and Service Manuals can be open according to the log-in

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5. Sample/Test Menu
a. Add/Remove samples to/from a tray
It is possible to add or remove samples directly to/from a sample tray in the sample menu. To
remove a sample the tray needs to be unloaded from the system.

b. In the sample menu a manual dilution factor can be programmed. The result will be
automatically corrected by the factor.

c. The dilution date and time is added to the detail screen on the Test Done menu.

d. Accepted results can be rejected on the Test Done screen.

e. Function to remove all samples from a tray was added to the sample tray menu.

6. Calibration Menu
a. The Lot number was added to the calibration set and traced up to the sample result.

b. Time of calibration curve creation was added to the date in the Calibration In Use menu.

c. Calibration Set menu a Diluted from concentrate was added. The new option allows
performing a pre dilution of the standards with user defined dilution rates.

2
d. Mean Error between the concentrations and the calculated concentrations and the R was
added to the Calibration menu.

e. An expiration date was added to the calibration set. It is not possible anymore to run a
calibration with an expired calibration set.

7. Maintenance
a. Maintenance Scheduler
The user can program a remainder for all maintenance task.

b. Cuvette Water Blank


To improve the quality of results the Cuvette Water Blank has been introduced into the weekly
maintenance schedule. It should be done after the intensive cuvette cleaning.
The background measurement of each cuvette at all 12 filters will be obtained and stored. The
process takes approximately 15 min and if acceptance criteria are fulfilled, cuvettes are considered
clean. The optical density of each result will be corrected using the stored value.
In the grid accepted limits are shown and bad cuvettes are displayed in red.

c. In the reaction tray menu, cuvettes which failed the water blank are displayed black and
strikeout with a yellow line.

d. Photometer Calibration
The change of cuvette 1 is not necessary anymore, due of the cuvette water blank

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8. Service / LIS
a. Cuvette Washer
To avoid splashes and drops outside the cuvettes, the washer moves during the dispensing
procedure some step further down.

b. ISE automatic priming


After the user changes the reagent pack of our ISE, the system will now prime automatically 10
time in order to remove bubbles from the tubings.

c. Stress Test Module


All movements of the mechanical parts are now included to the Stress Test Module. This allows an
easier location of cause of a mechanical problem.

d. Database
A shrink procedure of the database remove empty fields and will re-index the database to increase
the performance.

e. LIS
- To handle samples with priority a new field has been implemented to the LIS protocol. The field
needs to contain an S.
- Individual test results can be transmitted using the Test Done menu.
- Time stamp is added to the ErrorsLog communication

f. Debug
The debug section is now available for the SuperVisor of the Lab. It allows deactivating important
checks. If they do so they have to take the responsibility for it.

g. Monitor resolution: Screens were modified to be displayed in a 1366 x 768 monitor.

h. Software 2.5.0 is Windows 10 (32 and 64 bit) compatible.

9. User Manual
According to the new features the user manual has been updated. All chapters have been revised
to improve the usability for the end user.

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Necessary Tools / Software / Hardware
USB Stick min. 1GigaByte Memory
Software 2.5.0 with new Settings Version 4.0
Only for Windows 7 and 10 we dont support Windows XP anymore!

Instruction / Procedure
1. Software Update
Before you could start you have to update Windows and your Virus Scanner with the latest
provided updates. Be aware whiteout the latest update the software could create unexpected
errors. Virus or Trojans could destroy all your datas on the PC. Its in your responsibility to update
your system.

1.1. Complete New Installation

Download the file Rayo 2.5.0.zip from our Homepage and save the zip file on a USB
Stick.
Connect the analyzer with the PC (PC and analyzer should switch off)
Switch on the PC
Copy the zip file from USB Stick to the desktop of the HumaStar 600 Control PC.
Unzip the Rayo 2.5.0.zip
Double click on the Setup. HumaStar 600 v2.5.0 r2017-08-09.exe.


Press Next

Press Next

Press Install

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Press Finish

An Icon named Rayo should placed on the desktop.


Switch on the HumaStar 600
Restart the PC
Double click on the Icon Rayo
The HumaStar 600 User Software will start

1.2. Update from 1.9.X

Download the file Rayo 2.5.0.zip from our Homepage and save the zip file on a USB
Stick.
Connect the analyser with the PC (PC and analyser should switch of)
Switch on the PC
Save the folder c:/program(x86)/rayo to an external drive (USB Stick or Harddisk).
Copy the zip file from USB Stick to the desktop of the HumaStar 600 Control PC.
Unzip the Rayo 2.5.0.zip .
Double click on the Setup. HumaStar 600 v2.5.0 r2017-08-09.exe.


Press Next

Press Next

Press Install

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Press Finish

Switch on the HumaStar 600.


Restart the PC.
Double click on the Icon Rayo.
The HumaStar 600 User Software will start.
Check your Calibrator and Control Setting are correct.

2. Settings Update 4.0 mandatory for 2.5.0


With the New Software HUMAN provide New Settings. Please download the latest setting version
4.0 file from our Homepage

Copy the zip file to a USB Stick


Unzip the file
Switch on the PC
Start the HumaStar 600 Control Software Rayo
LogIn as Supervisor or Service
Put the USB Stick into the HumaStar 600 Control PC
Goto Data Import Methods

Select the drive containing the USB stick (e.g. f:)

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Select the directory Database and confirm with the button O.K.

In the method list displayed all new or changed methods are shown, new methods are already
selected in the check box. Additional selections can be made by activating other method check
boxes.

Confirm the selection with the button O.K. to import the method(s). If the import is
done below message will be displayed.

Notes
The User interface changed on different menus please be aware that all languages have to be updated.

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