Siemens CLINITEK Status User manual

Operator’s Manual
REF 10379682
+

134798 Rev. A, 2009 07
Operator’s Manual
+

© 2009 Siemens Healthcare Diagnostics Inc.
All rights reserved.
Clinitek, Clinitek Status, Multistix, Multistix PRO, Combistix, Uristix,
Labstix, Neostix, Clinitest and Chek-Stix are trademarks of
Siemens Healthcare Diagnostics.
Presept and Cidex are trademarks of Johnson & Johnson.
Theracide is a trademark of Lafayette Pharmaceuticals, Inc.
Amphyl is a trademark of Linden Corporation.
Kimwipes is a trademark of Kimberly-Clark.
US Pats 5,408,535; 5,477,326; 5,877,863; 6,239,445; D456,082; D489,816
Origin: UK
The information in this manual was correct at the time of printing.
However, Siemens Healthcare Diagnostics continues to improve products
and reserves the right to change specifications, equipment, and
maintenance procedures at any time without notice.
If this instrument is used in a manner differently than specified
in this manual, the protection provided by the equipment may
be impaired.
Siemens Healthcare Diagnostics Ltd.
Sir William Siemens Sq.
Frimley, Camberley, GU16 8QD, UK
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY 10591-5097 USA

iii
Table of Contents
A Brief Description ............................................................ v
Understanding the Symbols and Display Icons .............. vii
1 Unpacking & Set Up ................................................. 1-1
Unpacking .....................................................................1-1
Set Up ...........................................................................1-2
Analyzer Set Up ............................................... 1-2
Plugging Analyzer In ........................................1-2
Installing Batteries ............................................ 1-2
Interfacing to a Computer ................................. 1-3
Inserting Test Strip Table ..................................1-3
Loading Test Table Insert .................................1-3
Interfacing to the Clinitek Status Connector ..... 1-4
Analyzer Software Upgrades ...........................1-4
Loading the Printer Paper or Label Roll ...........1-5
Warranty Registration ....................................... 1-6
Powering Up .................................................................. 1-7
Powering Down ............................................................. 1-8
2 Interacting with the Touch Screen .......................... 2-1
Screens .........................................................................2-1
Keyboards .....................................................................2-4
3 Start-Up Wizard ......................................................... 3-1
4 Testing ....................................................................... 4-1
Quick Tests .................................................................... 4-1
Urinalysis Strip Test .......................................... 4-1
Cassette Test ....................................................4-8
Full Tests ..................................................................... 4-13
Urinalysis Strip Test ........................................ 4-13
Cassette Test ..................................................4-22

iv
5 Instrument Set Up ..................................................... 5-1
Instrument Set Up ......................................................... 5-1
Language Settings ........................................................ 5-2
Password ......................................................................5-3
Operator and Patient Information ..................................5-4
Date and Time Settings ............................................... 5-14
Test Sequence Number ...............................................5-16
Instrument Settings ..................................................... 5-17
Restore Default Settings ............................................. 5-33
Diagnostics .................................................................. 5-34
Sample Interference Notes ......................................... 5-35
System Information ..................................................... 5-36
6 Recall Results ........................................................... 6-1
Patient Results .............................................................. 6-1
Sending Data to a PC ................................................... 6-3
7 Troubleshooting ........................................................ 7-1
List of Errors and Advisory Messages ........................... 7-4
Problem Checklist ......................................................... 7-8
8 Quality Control Testing ............................................ 8-1
9 Cleaning and Maintenance...............................................9-1
Cleaning ........................................................................9-1
Changing Batteries ........................................................ 9-7
10 Appendices............................................................ 10-1
Appendix A: Local Technical Support Providers
and Distributors ........................................................... 10-1
Appendix B: Tables of Results .................................... 10-2
Appendix C: Specifications ......................................... 10-8
Appendix D: Instrument Default Settings – English .... 10-10
Appendix E: System Overview & Principles ..............10-12
Appendix F: Training & Educational Materials ..........10-18
Appendix G: Sample Interference Notes ..................10-19
Appendix H: Safety Information ................................10-20
Appendix I: Clinitek Status®+ Intended Use
and Indications for Use ............................................. 10-22
11 Index..................................................................................... 11-1

v
NOTE: Feature availability may
vary by geography due to regulatory
registration.
NOTE: Due to software changes,
some screens on the instrument
may appear slightly different from
those in this manual.
What does the analyzer do?
Your Clinitek Status
®
+ analyzer is a
portable instrument for reading
Siemens Healthcare Diagnostics
urinalysis strips and Clinitest
®
immunoassay cassettes. No special
training is needed to use this
instrument. Several different Siemens
urinalysis strips (e.g., Multistix
®
10 SG)
can be used with the analyzer as well
as the Clinitest hCG Pregnancy Test.
The analyzer can be set up to be
as simple or sophisticated as you
prefer. You may simply insert a
dipped urinalysis strip or a Clinitest
cassette into the analyzer and the
result will be reported (this is called
a Quick Test).
Or, you have the option to enter
an Operator Name, Patient Name
and Patient ID. This added
information will be reported along
with the test results (this is called a
Full Test).
The touch screen displays
instructions and prompts you
through operation of the analyzer. In
addition, you enter information
through the touch screen.
Do I have to calibrate?
You do not have to do anything
to calibrate. The instrument
performs a system test each time it
is turned on. Then, each time a test
is run, the instrument automatically
calibrates. The white calibration bar
(on the test table) provides NIST
traceable calibration.
How does it work?
Testing starts (in the Quick Test
mode) when either the Strip Test
or Cassette Test is selected on the
main menu screen.
Touching the Strip Test key
prompts you to adjust the test table
to accept a urinalysis strip. Then
you touch the START key. You
have 8 seconds to dip the test strip,
blot the edge of the strip and place
it on the test strip table. The table is
partially pulled into the instrument
for calibration and then pulled
completely into the instrument to
read the test strip.
Touching the Cassette Test key
prompts you to adjust the test table
to accept a cassette. Then you
touch the START key. You have
8 seconds to draw the sample into
a pipette and dispense it into the
sample well of the cassette. The
analyzer automatically calibrates
and then pulls the table completely
into the instrument where the
cassette is read.
In the Full Test mode for either a
Strip Test or Cassette Test, you
are prompted to enter an Operator
Name, Patient Name and/or Patient
ID prior to running a test.
A Brief Description

vi
A Brief Description
How do I get results?
Results will be displayed on the
touch screen and printed (if
desired). The results can also be
transferred to a computer using a
9-pin null modem serial cable and
the RS-232 serial port on the back
of the instrument.
The analyzer stores results from
950 patient tests. You are able to
recall past patient test results on
the analyzer using the Recall
Results function.
How is the analyzer powered?
The analyzer can be plugged
into an electrical outlet for use on
the bench top, or it can be powered
by batteries and freely moved from
one testing site to another. The
batteries fit into an opening on the
bottom of the instrument.
What about this Operator’s
Manual?
The Operator’s Manual contains
the directions you need to unpack
the analyzer, use it for your daily
Siemens urinalysis and Clinitest
immunoassay testing and keep it in
good working condition.
As you read through the
Operator’s Manual, you will find
these symbols:
In the Operator’s Manual, you will
notice some text is in bold/italic or
bold.
Bold/italic text identifies screen names.
NOTES: contain useful tips
on using the analyzer. Notes
appear in italicized type.
Bold text identifies a button
(touch sensitive area) on the
screen.
CAUTION: should be
followed carefully to ensure your
analyzer operates correctly and
is not damaged. Cautions
appear in bold type.

vii
Instrument and Labeling Symbols
This section describes the symbols that appear on the exterior of the
Clinitek Status+ analyzer, the power supply provided with the instrument,
the carton in which the instrument was delivered and the supplies of
reagent strips and cassettes which you will use with the instrument.
Indicates that the input supply is direct current
Identifies that the instrument is type B equipment, which
provides a particular degree of protection against electric shock
Identifies that the instrument is class 111 type equipment,
which is equipment for connection to SELV (Separated Extra
Low Voltage), i.e. a power supply
Double insulated product or transformer may also identify
class 2 equipment (power supply only)
Identifies that the instrument is listed by Underwriters
Laboratories as meeting U.S. and Canadian requirements for
safety
The CE mark identifies that the product complies with the
applicable directives of the European Union
Manufacturer
European authorized representative
Indicates a power on/off button
Caution, consult accompanying documents
In vitro diagnostic medical device
Consult instructions for use
Understanding the Symbols and Display Icons
Class 111

viii
Understanding the Symbols and Display Icons
Indicates a serial port
This system contains certain toxic or hazardous substances or
elements. The environmental protection use period for this
system is 50 years. The system can be used safely during its
environmental protection use period. The system should be
recycled immediately after its environmental protection use
period has expired.
Temperature limitation (18°30°C)
Contents sufficient for (n) tests (100)
Use by YYYY MM
Catalog number
Serial number
Batch code
Biohazard
Indicates that this equipment is classified as Waste Electrical
and Electronic Equipment under the European WEEE
Directive. It must be recycled or disposed of in accordance
with applicable local requirements.
Printed on recycled materials
Indicates compliance with RESY packaging standards
100
18
30