GLOBAL PRODUCT SUPPORT

Support Bulletin 24981 Rev. B Action

CLINITEK Status® System December 2010

Availability of CLINITEK Status Software Version 2.300

Purpose
Notifies countries of a new, non-mandatory software version shipped with CLINITEK
Status® instruments, and of the availability of software upgrade kits.
This bulletin replaces 24981 Rev A.

Scope
Applicability: CLINITEK Status Instruments
Business Group: Point of Care
Category: Software
Complete At: Next Failure
Cut-in Serial Number: CLINITEK Status+ serial number 205439
Estimated Time: Approximately 10 minutes
MOD Code: Not applicable
Update Number: PC018/10/R

Disclaimer
The installation and service of equipment described herein is to be performed by
qualified personnel who are employed by Siemens or one of its affiliates or who are
otherwise authorized by Siemens or one of its affiliates to provide such services.
Assemblers and other persons who are not employed by or otherwise directly
affiliated with or authorized by Siemens or one of its affiliates are directed to contact
one of the local offices of Siemens or one of its affiliates before attempting
installation or service procedures.

Bulletin Number: 24981 Rev. B © 2010 Siemens Healthcare Diagnostics Inc. All rights reserved.
GPS-F-002-1 DCM Rev. 2.0 Effective: May, 24th, 2010 Proprietary Information of Siemens Healthcare Diagnostics
Related Procedure: GPS-P-002, DX Support Bulletin Communication Page 1 of 6
Availability of CLINITEK Status® Software Version 2.300

Materials
Ordering Information
Kits for use in the US may be ordered from the Atlanta Parts Center (APC). Outside
the US, contact Elaine Williams (elaine.ew.williams@siemens.com).

Parts
Description Part Number/SMN Qty

Status V2.3 s/w upgrade kit USA 10629773 1

Impact on Spare Parts Inventory

Version 2.3 is a non-mandatory software update. Version 2.2 may still be stocked
and used.

Description
Several reports have been received of CLINITEK Status analyzers at software
version 2.0 and higher misreporting ID-banded urine test strips. Typically
Multistix® 10SG (with ID band) strips have been reported as Multistix PRO® 10LB,
which is not a marketed product. This can be caused by poor dipping technique, and
the analyzer's subsequent misinterpretation of the ID band as a color band due to
urine on the ID band. Software version 2.3 removes Multistix PRO 10LB and other
unused strip types from the instrument menu.
Strip types removed:
• Multistix PRO 6B
• Multistix PRO 6K
• Multistix PRO 10SB
• Multistix PRO 10LB
• Multistix PRO 10
• Multistix PRO 7pH
This change does not affect any of the other strip types.
The instrument will now report an error code (E50 – incorrect strip type or tilted strip)
instead of misreporting the strip type. A future software version will have an improved
algorithm for strip detection.

Next Steps
Offer this software upgrade to customers who complain of misreported strip types.

Bulletin Number: 24981 Rev. B © 2010 Siemens Healthcare Diagnostics Inc. All rights reserved.
GPS-F-002-1 DCM Rev. 2.0 Effective: May, 24th, 2010 Proprietary Information of Siemens Healthcare Diagnostics
Related Procedure: GPS-P-002, DX Support Bulletin Communication Page 2 of 6
Availability of CLINITEK Status® Software Version 2.300

Additional Information
One software kit can be used to update multiple CLINITEK Status analyzers.
Software version 2.300 can be installed over all previous software versions;
however, it will not be possible to revert to software version 1.x unless the final
release test procedure is used to restore calibration data.
A software revision history is included as Appendix A in this bulletin.

Customer Information
Software upgrade instructions (English only) are included in the software upgrade kit.
Customer bulletins 22185rc (outside US) and 22186rc (US only) were issued
describing the features of ID-banded strips and reinforcing correct dipping technique.

Trademark Information
CLINITEK, CLINITEK Status, and Clinitest are trademarks of Siemens Healthcare
Diagnostics. Multistix and Multistix PRO are trademarks of Bayer HealthCare and are
licensed for use by Siemens Healthcare Diagnostics.

Additional Assistance
If you need additional assistance, please contact Global Product Support – Sudbury,
UK.

Bulletin Number: 24981 Rev. B © 2010 Siemens Healthcare Diagnostics Inc. All rights reserved.
GPS-F-002-1 DCM Rev. 2.0 Effective: May, 24th, 2010 Proprietary Information of Siemens Healthcare Diagnostics
Related Procedure: GPS-P-002, DX Support Bulletin Communication Page 3 of 6
Availability of CLINITEK Status® Software Version 2.300

Appendix A: Software Revision History

Each software revision contains the features implemented in previous versions.

Version 1.000
• Initial Release

Version 1.100
• Added Japanese and Chinese Language to UI
• Added JCCLS glucose reported results format for Japan
• Improved error checking for Clinitest® hCG Cassette
• Implemented auto-send to PC connectivity
• Corrected the strip identification issue with Multistix 7
• Improved error detection for misidentification or skewed strip
• Changed the battery auto-shutoff from 30 seconds to 3 minutes

Version 1.200
• Corrected the issue with Clinitest® hCG flow detection instrument lockup

Version 1.300
• Updated decode points for protein (Japan only)
• Enhanced print intensity
• 2003 date removed from each result printout
• Bayer name updated on display and printouts

Version 1.400
• Updated decode points for protein
• Updated decode points for nitrite
• Implemented urine color compensation algorithm for nitrite

Version 1.500
• Improved printer font for Japanese and Chinese characters
• Added ability to print both Patient Name and Patient ID
• Improved strip detection on power down

Bulletin Number: 24981 Rev. B © 2010 Siemens Healthcare Diagnostics Inc. All rights reserved.
GPS-F-002-1 DCM Rev. 2.0 Effective: May, 24th, 2010 Proprietary Information of Siemens Healthcare Diagnostics
Related Procedure: GPS-P-002, DX Support Bulletin Communication Page 4 of 6
Availability of CLINITEK Status® Software Version 2.300

Version 1.600
• Disabled tilted strip algorithm for CLINITEK Microalbumin strips

Version 1.700
• Siemens Diagnostics name change on display and printouts
• Improved password functionality
• Print intensity increased for Chinese and Japanese versions
• Optimized decodes for old/new CCD detector

Version 1.800
• Added CLINITEK Microalbumin 9
• Renamed CLINITEK Microalbumin to CLINITEK Microalbumin 2
• Added “*” flag for Abnormal A:C ratio results for CLINITEK Microalbumin 2

Version 1.900
• Manufacturing release
• Improved timekeeping

Version 2.000 (outside US only)

• Support for ID banded strip Auto-Checks
• Auto strip identification
• Strip integrity check
• Sample interference notes
• Lot number and expiration entry
• Operator ID (lockout)
• Customized results reporting
• Enhanced sample appearance options
• Customizable printouts
• Support for CLINITEK Status connector
• Connectivity (wireless and wired - Ethernet/serial)
• QC testing and lockout
• Barcode capability
• Instrument setup copy/restore functionality

Bulletin Number: 24981 Rev. B © 2010 Siemens Healthcare Diagnostics Inc. All rights reserved.
GPS-F-002-1 DCM Rev. 2.0 Effective: May, 24th, 2010 Proprietary Information of Siemens Healthcare Diagnostics
Related Procedure: GPS-P-002, DX Support Bulletin Communication Page 5 of 6
Availability of CLINITEK Status® Software Version 2.300

Version 2.200
• Introduction of v2.000 features to US
• Introduction of startup code for customers outside US (to allow access to
sample interference notes)

NOTE: Software version number 2.100 was not used.

Bulletin Number: 24981 Rev. B © 2010 Siemens Healthcare Diagnostics Inc. All rights reserved.
GPS-F-002-1 DCM Rev. 2.0 Effective: May, 24th, 2010 Proprietary Information of Siemens Healthcare Diagnostics
Related Procedure: GPS-P-002, DX Support Bulletin Communication Page 6 of 6