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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

16660I_HSB_0017 Software and Setting Update_final.docx Form 7.2-02.06-01
Vers. 01
1 / 10 Valid from 04.05.2017

Smaller Kit Sizes for Reagents available For the following tests the setup in the Database is made for two different kit sizes. Stability Time Display The display of the stability time has changed from weeks to days (1 to 120) for following functions: .docx Form 7. liquiUV GOT 12021300 2 x 200 12021600 2 x 310 GPT (ALAT) IFCC mod.06-01 Vers. The kits will be available to order in the end of September 2017.Onboard Stability .0h 1. all negative results will reported as zero 16660I_HSB_0017 Software and Setting Update_final.B. Calculated methods are now “Open Methods” g.05. New Features of SW version 2. In the end of the year more tests will be added. Methods: a. Negative Results display/report: If the lower concentration limit is set to zero and no repeat run is activated. e. Predilution The sample pre dilution can be applied to calibrator and QC f. Minimum reaction volume The minimum dispensing volume to the cuvette (before the first reading) is decreased to 180 µl. 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. 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 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.2-02.2017 . Description Name REF Tests/Kit Ref Tests/Kit ALKALISCHE PHOSPATASE liquicolor (IFCC) APAMP 12117300 2 x 150 12117600 2 x 250 ALKALISCHE PHOSPATASE opt.5. c. 01 2 / 10 Valid from 04.calibration Stability d. Units The software allows the definition of a method without a Unit.Reagent Blank Stability .

CV is rounded with 2 decimal position . 3. just tick the box for “Keep using”. b. The changes are under their responsibility. “Units conversion” was renamed to “Method Correlation”. Units &Limits: All function can be changed only by a SuperVisor. 2.2017 . Open the menu methods>Units & Limits a. The number of default replicas for the “Reagent Blank” can be changed.05. 01 3 / 10 Valid from 04.Date and point number was added to the printout 16660I_HSB_0017 Software and Setting Update_final. QC Statistic Levey Jennings graph display and printout: .docx Form 7. QC Menu: a. “Keep Using” function for reagents: The on board stability given from Human reagents can be extended.The “In-Range” (min/max) zone is displayed green .2-02.results out of concentration validity limits are not taken into calculation of statistics or shown in the graph . c.SD was added to the left axis and values/ unit was added to the right axis .06-01 Vers.

docx Form 7. The current operation status will be displayed such as Initialization. New “Statistic” Menu was implemented QC data can be displayed or printed for a special time period 4. Photometer Calibration Clot Calibration and Intensive Washer Cleaning. Main Screen a.Expected mean was added . User and Service Manuals can be open according to the log-in 16660I_HSB_0017 Software and Setting Update_final.Copy function was implemented to create a new Qc set using an existing set d. 01 4 / 10 Valid from 04.2-02. Intensive Cuvette Cleaning. Cuvette Check. Warming up. b. Tip cleaning. Cuvette Washing. System Flush. An “Eventlog” for the system and ISE are added to the main screen.06-01 Vers.Lot number is mandatory . Cuvette Blank.changes in limits are applied to already tun tests for the corresponding QC Set and Lot number .05. c. b. QC Set . Estimated time to finalize sample processing was added. QC Done screen – the option to delete QC results is removed c.2017 .

due of the cuvette water blank 16660I_HSB_0017 Software and Setting Update_final.2-02. d. In the reaction tray menu. e. The Lot number was added to the calibration set and traced up to the sample result. An expiration date was added to the calibration set. The new option allows performing a pre dilution of the standards with user defined dilution rates. b. 5. The process takes approximately 15 min and if acceptance criteria are fulfilled. 2 d. Accepted results can be rejected on the Test Done screen. Calibration Set menu a “Diluted from concentrate” was added. It is not possible anymore to run a calibration with an expired calibration set.05.06-01 Vers. In the sample menu a manual dilution factor can be programmed. Function to remove all samples from a tray was added to the sample tray menu. The background measurement of each cuvette at all 12 filters will be obtained and stored.2017 . Maintenance Scheduler The user can program a remainder for all maintenance task. The dilution date and time is added to the detail screen on the Test Done menu. Photometer Calibration The change of cuvette 1 is not necessary anymore. c. cuvettes are considered clean. c. b. cuvettes which failed the water blank are displayed black and strikeout with a yellow line. Maintenance a. The optical density of each result will be corrected using the stored value. e. In the grid accepted limits are shown and bad cuvettes are displayed in red. Time of calibration curve creation was added to the date in the “Calibration In Use” menu. Mean Error between the concentrations and the calculated concentrations and the R was added to the Calibration menu.docx Form 7. 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. Sample/Test Menu a. Calibration Menu a. The result will be automatically corrected by the factor. It should be done after the intensive cuvette cleaning. d. 6. Cuvette Water Blank To improve the quality of results the “Cuvette Water Blank” has been introduced into the weekly maintenance schedule. b. 01 5 / 10 Valid from 04. 7. c. To remove a sample the tray needs to be unloaded from the system.

the system will now prime automatically 10 time in order to remove bubbles from the tubing’s.Time stamp is added to the ErrorsLog communication f. Stress Test Module All movements of the mechanical parts are now included to the Stress Test Module. Monitor resolution: Screens were modified to be displayed in a 1366 x 768 monitor. Database A shrink procedure of the database remove empty fields and will re-index the database to increase the performance. 16660I_HSB_0017 Software and Setting Update_final. All chapters have been revised to improve the usability for the end user. b. The field needs to contain an “S”. e.2-02. User Manual According to the new features the user manual has been updated. g.06-01 Vers.05. This allows an easier location of cause of a mechanical problem. h.Individual test results can be transmitted using the “Test Done” menu. Debug The debug section is now available for the SuperVisor of the Lab. . ISE automatic priming After the user changes the reagent pack of our ISE. LIS . It allows deactivating important checks. 9. Service / LIS a. If they do so they have to take the responsibility for it. the washer moves during the dispensing procedure some step further down. Cuvette Washer To avoid splashes and drops outside the cuvettes.0 is Windows 10 (32 and 64 bit) compatible. 01 6 / 10 Valid from 04.docx Form 7.5.To handle samples with priority a new field has been implemented to the LIS protocol. Software 2. .2017 . 8. d. c.

1. It´s in your responsibility to update your system. Complete New Installation  Download the file “Rayo 2.0.5.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.          Press “Next”  Press “Next”  Press “Install” 16660I_HSB_0017 Software and Setting Update_final. Virus or Trojans could destroy all your data’s on the PC.2017 .Necessary Tools / Software / Hardware USB Stick min. 01 7 / 10 Valid from 04.  Unzip the “Rayo 2.5.exe”.5.0 r2017-08-09.05. 1GigaByte Memory Software 2.06-01 Vers. 1.0 with new Settings Version 4. Be aware whiteout the latest update the software could create unexpected errors.zip”  Double click on the “Setup. Software Update Before you could start you have to update Windows and your Virus Scanner with the latest provided updates.docx Form 7.5.0 Only for Windows 7 and 10 – we don’t support Windows XP anymore! Instruction / Procedure 1.2-02.0. HumaStar 600 v2.

5.0 r2017-08-09.05.zip” .exe”. Update from 1.  Press “Finish”  An Icon named “Rayo” should placed on the desktop.2.  Double click on the “Setup.0.zip” from our Homepage and save the zip file on a USB Stick.5. 01 8 / 10 Valid from 04.  Unzip the “Rayo 2.docx Form 7.2017 .2-02.9.5. HumaStar 600 v2.0.  Copy the zip file from USB Stick to the desktop of the HumaStar 600 Control PC.06-01 Vers.  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).          Press “Next”  Press “Next”  Press “Install” 16660I_HSB_0017 Software and Setting Update_final.X  Download the file “Rayo 2.  Switch on the HumaStar 600  Restart the PC  Double click on the Icon “Rayo”  The HumaStar 600 User Software will start 1.

 Check your Calibrator and Control Setting are correct. f:) 16660I_HSB_0017 Software and Setting Update_final.2-02.  Double click on the Icon “Rayo”.  Restart the PC. Settings Update 4.0 mandatory for 2. 2.g.  Press “Finish”  Switch on the HumaStar 600.5.06-01 Vers.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.  The HumaStar 600 User Software will start.0 With the New Software HUMAN provide New Settings. 01 9 / 10 Valid from 04.2017 . Please download the latest setting version 4.05.docx Form 7.

 In the method list displayed all new or changed methods are shown.  Confirm the selection with the button “O.05.K. If the import is done below message will be displayed. new methods are already selected in the check box.2-02. Notes The User interface changed on different menus – please be aware that all languages have to be updated.” to import the method(s).06-01 Vers.  Select the directory “Database” and confirm with the button “O.K”. 16660I_HSB_0017 Software and Setting Update_final.2017 .docx Form 7. Additional selections can be made by activating other method check boxes. 01 10 / 10 Valid from 04.