HUMAN SERVICE BULLETIN 0001

HumaLyzer 4000

Subject Settings Version 1.02

Issue date 05.04.2019
Author Florian Schardt
Instrument(s) HumaLyzer 4000 (REF 18250)
Serial number  All
range  From: …
 To: …
Implementation  Immediately
 Next service
 Upon problem occurrence
 Information
Part(s) recall  Yes
 No
 Not applicable

Brief description

This HSB provides information of the newest update of the Settings Version 1.02.

The update should be installed immediately, because it avoids false “M”-flags when measuring
controls, calibrators or blanks. Previously also very small bubbles were detected which do not
influence the result. The threshold for triggering this flag is now increased and only relevant bubbles
will be detected.

Furthermore the correlation factors for GOT and LDH have been adjusted. The measuring range of HDL
and ALP is changed.

Details about the new Settings Database

GOT: Correlation factor increased

LDH: Correlation factor decreased
HDL and ALP: Change of measuring range ("Conc. max.")

Increased micro bubble detection threshold for "Others" (QC, CAL, BLANK) to avoid false flags (for all
settings that use micro bubble detection).

HSB HumaLyzer 4000 Form 7.2-02.06-01

Vers. 01
1/4 Valid from 04.05.2017
Installation

Read the user manual for further information.

a. Extract the “methods” folder from the zip-file to a USB-stick.

The USB-stick must have a folder “\methods” which contains all the met-files.

b. Login as “Admin” or above.

c. Insert the USB-Stick into the analyzer.
d. Click “TOOLS”.

e. Click “BACKUP/UPDATE”.

HSB HumaLyzer 4000 Form 7.2-02.06-01

Vers. 01
2/4 Valid from 04.05.2017
 f. Click on the “Methods” tab.

g. Click „COPY ALL“ to update all methods on the instrument. (Click „UPDATE“ if you need to
update only a single method.)
h. Confirm the update for all methods that have a new version compared to the old method on
the instrument. Click “Update”.

i. Methods with the identical version and date/time are not required to be updated, because the
latest version is already installed on the analyzer. Click “Cancel”.

j. The method “VER” should always be updated, because it indicates the version of the complete
settings database.

k. After having updated all methods, click “Yes” to remove the USB stick.

l. Check all new methods and re-insert the information for unit, QC, calibrators, reference range
etc.

HSB HumaLyzer 4000 Form 7.2-02.06-01

Vers. 01
3/4 Valid from 04.05.2017
 m. All new methods must be calibrated and controls must be run to validate the performance.

HSB HumaLyzer 4000 Form 7.2-02.06-01

Vers. 01
4/4 Valid from 04.05.2017