Clinitek Status Plus Operator Manual PDF

+
Operator’s Manual
REF 10379682
+
Operator’s Manual
134798 Rev. A, 2009 07

© 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
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY 10591-5097 USA
Siemens Healthcare Diagnostics Ltd.

Sir William Siemens Sq.
Frimley, Camberley, GU16 8QD, 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.
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
iii
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
iv
A Brief Description
NOTE: Feature availability may Do I have to calibrate?
vary by geography due to regulatory
registration. You do not have to do anything
to calibrate. The instrument
NOTE: Due to software changes, performs a system test each time it
some screens on the instrument is turned on. Then, each time a test
may appear slightly different from is run, the instrument automatically
those in this manual. calibrates. The white calibration bar
(on the test table) provides NIST
What does the analyzer do? traceable calibration.
Your Clinitek Status®+ analyzer is a How does it work?

portable instrument for reading
Siemens Healthcare Diagnostics Testing starts (in the Quick Test
urinalysis strips and Clinitest® mode) when either the Strip Test
immunoassay cassettes. No special or Cassette Test is selected on the
training is needed to use this main menu screen.
instrument. Several different Siemens Touching the Strip Test key
urinalysis strips (e.g., Multistix® 10 SG) prompts you to adjust the test table
can be used with the analyzer as well to accept a urinalysis strip. Then
as the Clinitest hCG Pregnancy Test. you touch the START key. You
The analyzer can be set up to be have 8 seconds to dip the test strip,
as simple or sophisticated as you blot the edge of the strip and place
prefer. You may simply insert a it on the test strip table. The table is
dipped urinalysis strip or a Clinitest partially pulled into the instrument
cassette into the analyzer and the for calibration and then pulled
result will be reported (this is called completely into the instrument to
a Quick Test). read the test strip.
Or, you have the option to enter Touching the Cassette Test key
an Operator Name, Patient Name prompts you to adjust the test table
and Patient ID. This added to accept a cassette. Then you
information will be reported along touch the START key. You have
with the test results (this is called a 8 seconds to draw the sample into
Full Test). a pipette and dispense it into the
The touch screen displays sample well of the cassette. The
instructions and prompts you analyzer automatically calibrates
through operation of the analyzer. In and then pulls the table completely
addition, you enter information into the instrument where the
through the touch screen. 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.
v
A Brief Description
How do I get results? the analyzer, use it for your daily
Siemens urinalysis and Clinitest
Results will be displayed on the immunoassay testing and keep it in
touch screen and printed (if good working condition.
desired). The results can also be
transferred to a computer using a As you read through the
9-pin null modem serial cable and Operator’s Manual, you will find
the RS-232 serial port on the back these symbols:
of the instrument.
The analyzer stores results from
950 patient tests. You are able to NOTES: contain useful tips
recall past patient test results on on using the analyzer. Notes
the analyzer using the Recall appear in italicized type.
Results function.
CAUTION: should be
How is the analyzer powered? followed carefully to ensure your
analyzer operates correctly and
The analyzer can be plugged is not damaged. Cautions
into an electrical outlet for use on appear in bold type.
the bench top, or it can be powered
by batteries and freely moved from
one testing site to another. The In the Operator’s Manual, you will
batteries fit into an opening on the notice some text is in bold/italic or
bottom of the instrument. bold.
What about this Operator’s Bold/italic text identifies screen names.

Manual?
The Operator’s Manual contains

the directions you need to unpack
Bold text identifies a button

(touch sensitive area) on the
screen.
vi
Understanding the Symbols and Display Icons
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
Class 111 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
vii
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.
30
18 Temperature limitation (18° 30° C)
100 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
viii
Keep this way up
Fragile, handle with care
Keep dry
Keep away from sunlight and heat
VDE Testing and Certification Institute Germany
Manufacturer’s mark (FRIWO) and manufacturing location

(Hong Kong)
Manufacturer’s mark (FRIWO) and manufacturing location

(Geratebau, Germany)
Encapsulated safety isolating transformer (short circuit proof)
Positive Temperature Coefficient (PTC) A thermistor device

used to protect the transformer from short circuits or overload.
This is an auto reset device.
Thermal cut out (TCO) This safety device disconnects the

supply voltage to the transformer at a specific temperature.
The operation temperature is stated below.
Ingress protection rating protected against the entry of solid

objects >1 mm but no protection from liquids.
This symbol indicates a risk of electric shock.
ix
Display Icons
There are seven icons which display in the top left of the display to show
the mode of the instrument. They also appear on the selection area for
each function. The icons are:
Instrument Set Up
This is displayed when the instrument is being set up to suit the
users’ requirements.
Strip Test (e.g., Multistix 10SG)

Shown when a test is being carried out using a reagent strip for
urinalysis, and when results are displayed following a strip test.
Cassette Test (e.g., Clinitest hCG)

Displayed when a cassette test is being carried out and when
results are shown after a cassette test.
Results recall
Used to show that results are being recalled from the
instrument’s memory.
Printer
This icon is displayed when results are being printed.
Data transfer to Personal Computer

Shows that data, including results, is being transferred to a PC.
Alert
Used when an error is being displayed.
There are two icons which may appear in the title bar.
Battery power
This has a maximum of four segments which show the level of
battery power. It will be shown in the top right corner of the title
bar when the instrument is battery powered.
Paper out
Appears in the top of the title bar when the printer paper/label
roll needs replacing.
x
1 Unpacking & Set Up
Unpacking
Unpacking
1 Carefully remove the contents 2 Remove each of the wrappings

of the shipping carton. Check the and check for the following items:
carton and instrument for visible
signs of damage; if seen,
immediately contact the carrier.
1 4
2
3
1 Clinitek Status®+ analyzer 4 Power Supply
2 Test table If the power cord is not the style

Do not touch the white you need, contact your local
calibration bar. representative (for a list of contacts see
Appendix A, Local Technical Support
3 Test table insert Providers and Distributors).
If you are using a reagent strip 5 Paper Roll

that has 4 or fewer test pads,
e.g., Uristix® 4, you must use a short
Depending on the model you have
test table insert. This has to be ordered
received, there may also be a Warranty
separately (for a list of suppliers see
Registration Card, Unpacking/Setup Guide,
Appendix A, Local Technical Support
and/or Quick Reference Guide included.
Providers and Distributors).
1-1
Set Up
Set Up
3 Analyzer Set Up
The best temperature for using
Place the instrument on a level the instrument is between 22°C and
work surface where the 26°C (72°F and 79°F). Do not place
the analyzer outside or near
temperature and humidity are fairly windows, ovens, hot plates, or
constant. radiators.
4 Plugging Analyzer In
Plug the appropriate end of the

power cord into the power inlet
socket located on the rear of the
Clinitek Status+ analyzer. Plug the
other end of the power cord into an
AC electrical wall outlet.
Only use the power supply

adapter included with the unit.
5 Installing Batteries
(Optional)
Place the analyzer on its side and

remove the battery cover by
pressing down on the tab and
pulling out. Place the 6 new
alkaline AA-size batteries into the
analyzer. Replace the battery cover
and turn the instrument back onto
its base.
1-2
Set Up
6 Inserting Test Strip Table
Insert the test strip table into the

analyzer by holding it by the end
opposite the white calibration bar
and with the white bar facing up.
Push the test table into the
analyzer, pushing it in just over
halfway.
Do not push the test table fully

into the analyzer as the test table
may become jammed and prevent
the use of the analyzer.
Do not touch the white

calibration bar.
7 Loading Test Table Insert
The test table insert adapts for use

with a Siemens Healthcare
Diagnostics urinalysis strip or
Clinitest immunoassay cassette.
One side is used for a strip test and
the other side is used for a cassette
test.
8 Interfacing to a Computer
The instrument can send results to

a computer via the serial port
located on the back of the analyzer.
This requires a 9-pin null modem
serial cable that can be purchased
separately at an electronics store or
from your Siemens Representative
(for a list of suppliers see Appendix
A, Local Technical Support
1-3
Set Up
9 Interfacing to the
Clinitek Status Connector
The Clinitek Status connector

allows for Ethernet or wireless
network connectivity, Quality
Control, increased security, bar
code scanning, and additional
features with the Clinitek Status+
analyzer.
This connector provides standard
wired and wireless connectivity of
the Clinitek Status+ system to your
LAN, LIS, HIS, EMR, and allows
for centralized control of all
satellite Point of Care (POC)
Clinitek Status+ analyzers.
Refer to the Clinitek Status
Connect System Operator’s Guide.
10 Analyzer Software Upgrades
From time to time Siemens will add

new features and make improvements
to the Clinitek Status+ instrument
software.
These software updates will be

available on an electronic memory
card which is inserted into the
software update socket. This socket
is located under the printer cover
and is on the left-hand side of the
printer when you face the back of
the instrument.
Updating the software is a simple

procedure. Instructions for updating
the software on your instrument will
be supplied with the memory card.
1-4
Set Up
11 Loading the Printer Paper or

Label Roll
1. Open the printer cover by pulling

up on the tab.
2. Open the paper roll compartment

cover by pressing down on its tab
and pulling out.
3. Lift the paper holding arm into

the open, upright position.
4. Place the new paper roll into the

printer paper compartment with the
paper unrolling from underneath
and toward the compartment wall.
5. Feed the paper up along wall

and through the printer. Once you
have approximately 4 inches (or
10 cm) of paper through the printer
then feed the edge of the paper
through the printer cover.
paper holding arm
6. Push the paper holding arm
down in to the closed position.
7. Close the printer and paper roll The analyzer uses ordinary
covers by clicking them into thermal paper as provided, or label
position. stock (for ordering information see
Appendix A, Local Technical
Support Providers and Distributors).
The analyzer is set up to
automatically print the results (to
turn off the automatic print function
see Section 5, Instrument Set Up).
1-5
Set Up
12 Warranty Registration
1. Lift the printer cover on the

instrument and the serial plate with
the instrument’s serial number will
be visible.
2. Write the serial number and

installation date on the Warranty
Registration Card. After the
instrument has been successfully
installed, complete the information
on the Warranty Registration Card
and return the card to your local
Siemens office (for a contact list
see Appendix A, Local Technical
Support Providers and
Distributors).
1-6
Powering Up
Powering Up
Press the on/off button located

on the front of the instrument.
This is the first screen displayed.

The analyzer will run an automatic
system diagnostic test each time it
is turned on.
If this is the first time you have

turned on the analyzer, you will be
led through a Start-Up Wizard, a
quick set-up procedure. If you
require further instruction regarding
the Start-Up Wizard see Section 3,
page 3-1.
1-7
Powering Down
Powering Down
1. Before turning the analyzer off,

always ensure that there is no strip
or cassette on the test table and
that the table and insert are clean.
2. Press the on/off button for

at least 2 seconds. The test table
will retract into the analyzer. If there
is no strip or cassette on the test
table, the door will close and the
analyzer will switch off.
If a strip or cassette is still on the

test table, the test table will be
pushed out and the analyzer will
turn off. The test table will remain
out. In order to retract the test table
into the analyzer, turn the analyzer
on, and then off (without a strip or
cassette on the test table).

1-8
2 Interacting with the Touch Screen
Screens
Screens
The touch screen will guide you

through the operation of the
Clinitek Status®+ analyzer. The
screen will display messages,
instructions and options to which
you respond by touching the
appropriate area on the screen.
The first main screen you see is the

Select screen. It displays the time
and date, and indicates the
5 possible actions: Title Bar
Icon
Instrument Set Up
Recall Results
QC Test
Cassette Test
Strip Test
Each screen that follows the Select

screen has an icon, title bar and
touch-sensitive active areas.
In some cases, the screen will also

display instructions, messages or
error messages.
The icon indicates the main section

in which you are working (1 of the Touch Sensitive Area
5 sections listed on the main
Select screen).
2-1
Screens
How to Touch the Screens

The screen needs to be touched If a touched area does not
respond as expected, slide your
lightly in the touch-sensitive area to finger across the appropriate
activate a response. selection area.
Use of anything hard or

Where to Touch the Screens pointed on the touch screen
There are three types of areas that may cause damage.
respond to touching the screen.
• Round Buttons
• Boxed Areas
• Scroll Arrows
Round Buttons
These buttons typically appear on
screens that require a selection
among several items. The button
with a filled circle is the current
selection.
To change your selection, touch an

unfilled circle. The newly selected
circle (button) will now be
highlighted. You then touch the
Next button to move to the next
screen. Round Buttons
In order to proceed, you will

always touch the box with a right
pointed arrow labeled Next.
In order to go back, you will

always touch the box with a left
pointed arrow. These “back” option
boxes vary in title.
2-2
Screens
Boxed Areas
These are areas on the screen
enclosed in boxes. Simply touch
any area within the box to activate
that function.
The boxed areas vary in size. The

boxes located on the main Select
screen are examples of larger
areas. Smaller box selections
include boxes such as the
“Previous” and “Next” boxes found
at the bottom of the screen.
Boxed Area Unavailable
Option
Scroll Arrows
Press the up and down arrows on
the right side of the screen to scroll
through the list of information on
the left side of the screen. Once the
information on the left side of the
screen is highlighted, touch the
Select button to confirm your
selection and move to the next
screen.
If there are double arrows on the

screen, these arrows (when
touched) will take you to the top or
bottom of the page.
When an option can be

selected it will be shown with a
thick black frame and will respond
when touched. If an option is not
available, it will be framed with a
thin black line and not respond
when touched.
2-3
Keyboards
Keyboards
Press to switch to
numeric keyboard
Using the Alpha-Numeric
Keyboard Back Space/
Data Entry Box
Erase key
When the screen prompts you to

enter information for Operator,
Patient’s Name and/or Patient
Identification, a keyboard will
appear on the screen.
Depending on how your analyzer is

set up, either an alphabetic or
numeric keyboard will be displayed
first. The first keyboard displayed is
referred to as “keyboard priority.”
If you require further instruction Return to Creates Confirm

regarding how to change keyboard previous blank data
priority see Section 5, Instrument Set screen space entries
Up.
To switch between the keyboards, Press to switch to

alphabetic keyboard
touch the 123 button to get to the
numeric keyboard. Touch the ABC
button to get to the alphabetic
keyboard.
To type in a name, number, birth

date, etc., touch the appropriate
button. Your selections will appear
in the data entry box.
If you switch between keyboards,

all values will be retained in the
data entry box on both keyboard
screens.
2-4
Keyboards
The maximum number of

characters allowed is 32. An
audible tone will sound when you
have exceeded the maximum
number of characters.
Once you have finished entering

the information, touch Enter (from
either keyboard screen).
2-5
2-6
3 Start-Up Wizard
The first time your Clinitek Status®+

analyzer is turned on (following an
automatic system diagnostic test), it
will take you through a quick set up
procedure. This procedure will
allow you to select the basic
functions of the analyzer so you
can use the analyzer with your
choice of settings.
The Start-Up Wizard will allow you

to select the following settings:
Language
Date and time
Preferred test sequence
(e.g., Quick Test or Full
Test)
Type of urinalysis strip
Results format
If you require further instruction

regarding how to change the settings
see Section 5, Instrument Set Up.
Once you have selected your

choices, the analyzer will display a
Confirmation screen which allows
you to check that your preferences
are correct.
3-1
3-2
4 Testing
Quick Tests
Quick Tests
Urinalysis Strip Test

BIOHAZARD Wear personal protective
equipment. Use universal precautions.
Refer to Appendix H for recommended
precautions when working with
biohazardous materials.
Testing is started from the main

Select screen.
If you require more information

regarding use and storage of test
strips, please refer to the strip package
insert.
Touch Strip Test to conduct a

urinalysis strip test.
The next screen that appears is

Prepare Test.
If you would like the steps for

urinalysis testing to be shown on the
screen then touch Help.
Make sure the test table insert has

the reagent strip holder facing
upward.
Also, have the test strip, urine

sample and paper towel ready.
Touch the START button.
4-1
4 Testing
Quick Tests

another Prepare Test. This screen
prompts you through the steps to
prepare the test strip.
A timer displays how much time

you have remaining to complete the
steps.
You have 8 seconds to complete

the following four steps:
1 Dip the reagent strip into the

urine sample, wetting all pads.
Immediately remove the strip from
the urine.
NOTE: Do not dip the automatic

identification band or color band
in the urine sample.
2 Drag the edge of the strip

against the side of the sample
container as you remove it.
4-2
4 Testing
Quick Tests
3 Blot by touching the edge of the

strip to the paper towel to remove
excess urine.
Do not lay the pads on the

paper towel or cover the pads by
the paper towel.
4 Place the reagent strip in the

channel of the table with the test
pads facing up. Slide strip to end of
the channel.
At the end of the 8 second

countdown, the test table and strip
will automatically be pulled into the
analyzer.
Do not push or pull the test

table.
The Clinitek Status®+ analyzer

will perform an automatic calibration
each time a test is run.
Be sure not to move or bump

the table while the instrument is
calibrating.
NOTE: A warning message

displays if you are not using a
Siemens reagent strip. Press OK to
continue. The Results may not
display if you are using a non-
Siemens reagent strip. Repeat the
test using a Siemens reagent strip.
4-3
4 Testing
Quick Tests
The Analyzing screen will be

displayed when the calibration has
been completed and the analysis of
the strip has begun.
A timer will count down the time

remaining in analyzing the strip
results.
If the analyzer has been set up to

automatically print the results, then
the Printing screen will be
displayed until the print out has
been completed (otherwise the
Results screen will appear).
The date, time and test sequence

number will be printed along with
the test results. “Not Entered” will
be printed next to Color and Clarity.
If the results are positive, an

asterisk* will appear next to the
results (if “mark positive results” was
selected in Instrument Set Up).
4-4
4 Testing
Quick Tests
The next screen displayed is the

Results screen. The first page of
the test results are displayed on the
screen and the test table and strip
are automatically pushed out of the
analyzer.
To view the remaining test results,

touch More on the screen.
If you are using reagent strips with

a color strip or auto identification
band, you can view Sample
Interference notes about this test.
From the Results screen, touch
Notes.
If Sample Interference notes are

generated for this test, the
Interference notes screen displays.
Touch the up and down arrows to
scroll through the notes. Touch
Done to return to the main Results
screen.
4-5
4 Testing
Quick Tests
Up to 5 Sample Interference notes

display on the screen. Use the up
and down arrows to scroll through
the notes. If enabled, the notes
print with the test results.
If Sample Interference notes have

been disabled in the setup, the
NOTES button does not display.
NOTE: If you run a test with this

feature disabled, no notes will be
generated at the time of the actual
test. If you enable the sample
interface notes then recall the test
results, the analyzer generates
Sample Interference Notes for this
patient test.
If the analyzer has not been set up

to automatically print the test
results, touch Print to have the
results printed.
The results will automatically be

sent to the connected PC if this
option is set up in the analyzer.

regarding how to set up the analyzer
so the results are printed or sent to a
computer automatically see Section 5,
Instrument Set Up.
4-6
4 Testing
Quick Tests
From the test table, remove the

used urinalysis strip and dispose of
it according to your standard
laboratory procedures. Wipe the
table insert, if necessary.
Report the results to a laboratory

supervisor or physician.
Touch Done to complete the test

and return to main Select screen.
The results will be displayed on
the screen for 2 minutes. After this time
elapses, the display will return to main
Select menu.
Touch Done to return the Strip Test

Prepare screen. You are ready to
start the next test. If testing is
complete, touch Back key to return
to the Select menu.
4-7
4 Testing
Quick Tests
Cassette Test

Select screen.
Please refer to the Clinitest® hCG

cassette test package insert for more
information regarding use and storage
of test cassettes.
Bring the test cassette and
patient sample to room
temperature 20°C to 30°C (68°F to
86°F) prior to testing.
Touch Cassette Test to conduct

the test.

Test Type. Touch the Clinitest
hCG cassette button.

Prepare Test screen.
If you would like the steps for

cassette testing to be shown on the
screen then touch Help.
4-8
4 Testing
Quick Tests
Make sure the test table insert is in

position for a cassette test.
Remove the test cassette from the

foil package and place the cassette
on the test table.
Once you touch the START

button you have 8 seconds to
draw the urine sample into the
pipette and add the urine sample
into the well on the cassette.
Touch START button.

another Prepare Test. This screen
prompts you through the steps to
prepare the cassette test.
A timer displays how much time

you have remaining to complete the
steps.
4-9
4 Testing
Quick Tests
You have 8 seconds to complete

the following two steps:
1 Draw the urine sample to the

line marked on the pipette
(approximately 0.2 mL).
2 Add entire contents of the

pipette into the sample well of the
test cassette.
At the end of the 8 second

countdown, the test table and
cassette will automatically be pulled
into the instrument.
Do not push or pull the test

table.
4-10
4 Testing
Quick Tests
The Clinitek Status+ analyzer will

perform an automatic calibration each
time a test is run.
Be sure not to move or bump

the table while the instrument is
calibrating.
The Analyzing screen will be

displayed when the calibration has
been completed and the analysis of
the cassette has begun.
A timer will count down the time

remaining in analyzing the cassette
results.
The Clinitest hCG test results are

either negative, positive or borderline.
The analyzer takes approximately
5 minutes to confirm a negative
result. If the result is a clear positive,
the analyzer will report it sooner. If
the result is borderline, then you
should retest, with a new sample, in
48 to 72 hours. Please refer to the
Clinitest hCG cassette test package
insert for complete instructions for
use.
4-11
4 Testing
Quick Tests
If the analyzer has been set up to

automatically print the results, the
Printing screen will be displayed
until the print out has been
completed (otherwise the Results
screen will appear).
The date, time and test sequence

number will be printed along with
the test results.
The next screen displayed is the

Results screen. The test results
are displayed on the screen and If the result is positive, an
the test table and cassette are asterisk* will appear next to the result
pushed out of the analyzer. (if “mark positive results” was
The results will be printed automatically
if this option is set up in the
analyzer. If not, touch Print to print
the results on the analyzer’s printer.

sent to the connected PC if this
option is set up in the analyzer.
so results are automatically printed or
sent to a computer see Section 5,
Instrument Set Up. The result will be displayed on
the screen for 2 minutes. After this
Remove the used cassette and time elapses, the display will return to
dispose of it according to your main Select menu.
standard laboratory procedures.
Report the results to a laboratory

supervisor or physician.
Touch Done to complete the test

and return to main Select screen.
4-12
4 Testing
Full Tests
Full Tests
Urinalysis Strip Test

A Full Strip Test allows you the

option to enter an Operator Name,
Patient Name and/or Patient ID
prior to inserting a strip.
The procedures to enter the

Operator and Patient data are
presented in this section.
The strip testing process is identical

to a Quick Strip Test.

regarding the procedures required for
running a Siemens Healthcare
Diagnostics urinalysis strip test see
Section 4, Quick Tests.

Select screen.
Touch Strip Test to conduct a

Siemens urinalysis strip test.
4-13
4 Testing
Full Tests

Operator Name.
There are two options under

Operator Name: Last Operator or
Enter New Operator Name.
Option 1: Last Operator

If this option is enabled, the last
operator that entered his/her Name
will be displayed on the screen in
the lower right side of the box. If
you are this operator, then touch
the Last Operator button to
proceed.
Option 2: Enter New Operator

Name
In order to enter the information for
a new operator, touch Enter New
Operator Name button. The next
screen that is displayed is Enter
Operator Name.
Use the keyboards to enter

Operator Name using a maximum
of 13 characters. Touch Enter
when you have finished entering
the Name and to move to the next
screen.

regarding keyboard usage see
Section 2, Interacting with the Touch
Screen.
4-14
4 Testing
Full Tests
The next screen displayed is

Patient Information.
There are two options under Patient

Information: Recall Patient or
Enter New Patient.
Option 1: Recall Patient

In order to look up previous
patients, touch Recall Patient.
If previous patient identification has

been entered, a list of up to 950
patient results will appear on the
screen. Use the up and down arrow
buttons to scroll through the list of
patients. The most recently
performed test will be shown at the
top. Once the patient is highlighted,
touch Select button.
The next screen will be Prepare

Test.
A total of 950 patient tests can

be stored in the analyzer. The tests
are listed in chronological order.
When the limit of 950 has been
reached, the oldest test will be
deleted from the analyzer. Deleted
information cannot be retrieved from
the analyzer.
4-15
4 Testing
Full Tests
Option 2: Enter New Patient

a new patient, touch Enter New
Patient button. The next screen
displayed is Enter Patient Name.
Use the keyboards to enter Patient

Name using a maximum of 20
characters. Touch Enter when you
have finished entering the patient’s
name and to proceed to the next
screen.

Screen.
4-16
4 Testing
Full Tests

Patient Identification. Use the
keyboards to enter Patient
Identification using a maximum of
13 characters. Touch Enter when
you have finished entering the
patient’s ID and to proceed to the
next screen.

Screen.
4-17
4 Testing
Full Tests

Prepare Test.

regarding the procedures for running
a Siemens urinalysis strip test see
While the strip is being analyzed, a

Select Appearance screen will be
displayed. The urine sample must
be visually observed and then the
appropriate color and clarity must
be selected.
If the urine sample is yellow and

clear, touch the Yellow and Clear
button.
If the urine sample is not yellow

and clear, touch the Other button
for more choices.
If you touched the Other button,

select the appropriate color by
touching the circle button that
corresponds to the correct
description.
NOTE: You can select only one

color for a urine sample.
4-18
4 Testing
Full Tests
Select the clarity by touching the

circle that corresponds to the
correct description. Then touch
Next.
There is a time indicator on the

Select Appearance screen that is
counting down the time remaining
in the analysis of the strip.
After color and clarity have been

entered the next screen displayed
will either be:
Analyzing – if the strip is still

being analyzed
Results – if analyzing the

strip has been completed
4-19
4 Testing
Full Tests
Entering the Strip Lot Number

and Expiration Date
To enter strip lot information for a

second strip test, perform the
following steps:
1. At the Select screen, touch Strip
Test.
The Strip screen displays.
2. To use the last strip number and
begin the test, touch Use Last
Lot.
To enter new strip data, touch
Enter new lot and expiration.
The Strip Lot screen displays.
3. Enter the strip lot number.
Use the alpha keyboard to enter
text.
To enter numeric text, touch 123.
4. Select Enter.
The Strip Expiration screen
displays.
5. Use the arrow keys to indicate
the strip expiration date.
6. Touch Enter.
The Prepare Test screen
displays.
7. Touch Start.
See above.
4-20
4 Testing
Full Tests
The test results displayed on the

screen and the printout will include
the following information:
Patient Name, ID or both

Type of strip used
Test date
Time
Operator
Test Number
Color
Clarity
Results
Sample Interference Notes
If the results are positive, an

asterisk* will appear next to the
results (if “mark positive results” was
4-21
4 Testing
Full Tests
Cassette Test
A Full Cassette Test allows you the

option to enter an Operator, Patient
Name and/or Patient ID prior to
inserting a cassette.
The procedures to enter the

Operator and Patient data are
presented in this section.
The cassette testing process is

identical to a Quick Cassette Test.

regarding the procedures for running
a Siemens Clinitest immunoassay test
see Section 4, Quick Tests.

Select screen.
Touch Cassette Test to conduct an

hCG pregnancy test.

Operator Name.

Operator Name: Last Operator or
Enter New Operator Name.
4-22
4 Testing
Full Tests
Option 1: Last Operator

If this option is enabled, the last
operator that entered his/her Name
will be displayed on the screen in
the lower right side of the box. If
you are this operator, then touch the
Last Operator button to proceed.
Option 2: Enter New Operator
Name
a new operator, touch Enter New
Operator Name button. The next
screen that is displayed is Enter
Operator Name.
Use the keyboards to enter

Operator Name using a maximum
of 13 characters. Touch Enter
when you have finished entering
the name and to move to the next
screen.
Screen.

Patient Information.

Patient Information: Recall Patient
or Enter New Patient.
4-23
4 Testing
Full Tests
Option 1: Recall Patient

In order to look up previous
patients, touch Recall Patient.
If the previous patient identification

has been entered, a list of up to
950 patients will appear on the
screen. Use the up and down arrow
buttons to scroll through the list of
patients. The most recently
performed test will be shown at the
top. Once the patient is highlighted,
touch the Select button. The next
screen will be Test Type.
A total of 950 patient tests can

be stored in the analyzer. The tests
are listed in chronological order.
When the limit of 950 has been
reached, the oldest test will be
deleted from the analyzer. Deleted
information cannot be retrieved from
the analyzer.
4-24
4 Testing
Full Tests
Option 2: Enter New Patient

a new patient, touch the Enter New
Patient button. The next screen
displayed is Enter Patient Name.
Use the keyboards to enter Patient

Name using a maximum of 20
characters. Touch Enter when you
have finished entering the patient’s
name and to move to the next
screen.

Screen.
4-25
4 Testing
Full Tests
The next screen displayed is Enter

Patient ID. Use the keyboards to
enter Patient Identification using a
maximum of 13 characters. Touch
Enter when you have finished
entering the patient’s ID and are
ready to proceed to the next
screen.

Screen.
4-26
4 Testing
Full Tests

Test Type.

regarding the procedures for running a
Clinitest hCG cassette test see
The test results displayed on the

screen and the printout will include
the following information:
Patient Name, ID or both
Type of Clinitest cassette test
Test date
Time
Operator
Test Number
Result
If the result is positive, an

asterisk* will appear next to the result
(if “mark positive results” was selected
in Instrument Set Up).
4-27
4-28
5 Instrument Set Up
Instrument Set Up
Instrument Set Up
Your Clinitek Status®+ analyzer

allows you to change settings to
suit your workplace requirements.
If no customizing is desired, the

analyzer will automatically be
programmed with default settings (to
view default settings please see
Appendix D: Instrument Default
Settings).
Touch Instrument Set Up in order

to initiate changing the settings.
If a password has been set, the

Enter Password screen will be
displayed. Enter the password into
the data entry box. The characters
you enter will be displayed as
asterisks.
Touch Enter to proceed to a list of

settings.
Settings
Use the up and down arrows to
scroll through the Choose
Settings screen.
Touch Select when you have

highlighted the setting you want to
change.
Touch Done to return to the main

Select screen.
5-1
5 Instrument Set Up
Language Settings
Language Settings

scroll through the list of languages.
Touch Select when you have
highlighted the desired language.
Before changing the language an

alert screen will be displayed
requesting you to confirm your
decision.
Touch No to continue with same

language and retain current
settings. The display will return to
Choose Settings.
Touch Yes to change the language.

Changing the language will…
delete all results from the
memory.
change the instrument
settings to the defaults for
the new language (default
settings are listed in
Appendix D: Instrument
Default Settings).
5-2
5 Instrument Set Up
Password
Password
When a password has been set,

no changes can be made to the
Instrument Set Up until the
password has been entered.
Set Password
Enter a password into the data
entry box using the alphabetic and/
or numeric keyboards (maximum
12 characters).
Keep a record of the password to
be sure to have access to Instrument
Set Up when required.
Touch Enter to confirm the

password and return to Choose
Settings.
Touch Done to return to main

Select screen.
Remove Password
Once a password has been entered
the option will change from Set
Password to Remove Password.
Highlight the Remove Password

option and touch Select. The
option displayed will change to Set
Password and a password will no
longer be needed to access
Instrument Set Up.
Touch Done to return to the Select

Menu.
5-3
5 Instrument Set Up
Operator and Patient Information
Operator and Patient

Information
Selecting this option will allow you

to choose display options for data
entry.
The Input Settings screen allows

you to select 1 of 3 test sequences.
Quick Test
A test without any operator or
patient information required. The
test will be identified by a
sequential test number when the
results are displayed or printed.
Full Test
The operator will be prompted to
enter the following data during
testing:
Operator Name
Patient’s Name
Patient Identification
Sample Appearance (Color
and Clarity) of urine
sample, when testing with
a urinalysis strip.
Custom Set Up
This allows you to customize the
data to be entered when
conducting a test.
5-4
5 Instrument Set Up
On the Input Settings screen,

touch a round button in the box of
the preferred test sequence. Then
touch Next for test sequence
confirmation.
Touch Done on the Input Settings

screen to return to the Choose
Settings screen.
5-5
5 Instrument Set Up
Custom Settings
Touch the round button in the
Custom Set Up box to customize
selections for data entry. Touch
Next.
The next 5 screens present choices

for customizing your testing.
Choose settings by touching and

highlighting a round button for each
category.
Proceed through all 5 screens by

touching Next at the bottom of
each screen.
Screen 1 of 5
Operator Name – allows you to
choose whether Operator Name
will be required for running a test –
Enabled (on) or Disabled (off).
Keypad priority – allows you to

select either the Numeric or
Alphabetic keyboard to be
presented as the first keyboard
during data entry.
5-6
5 Instrument Set Up
Screen 2 of 5
Patient Name – allows you to
choose whether patient name will
be required for running a test –
Enabled (on) or Disabled (off).
Patient ID – allows you to choose

whether Patient ID will be required
for running a test – Enabled (on) or
Disabled (off).
A total of 950 patient records

can be stored in the analyzer. When
the limit of 950 has been reached,
the oldest test will be deleted from
the analyzer. Deleted information
cannot be retrieved from the
analyzer. If Patient’s Name and
Patient ID are both disabled, a
sequential test number will be shown
with the test results.
Screen 3 of 5
Choose which to show in
Results list – allows you to choose
whether Patient Name or Patient
ID will be included in the list of
results.
Last Operator’s Name displayed

– allows you to choose whether a
“Select Last Operator” option is
available to the user when you are
prompted to enter an Operator
Name during Strip or Cassette
Testing – Enabled (on) or
Disabled (off).
5-7
5 Instrument Set Up
Screen 4 of 5
Choose which to record during a
strip test – allows you to select
which sample details you would like
to be recorded during a strip test –
Color and Clarity, Color only,
Clarity only or None (no sample
information).
Screen 5 of 5
Custom Field – allows you to
name the custom field in order to
customize data entry.
To name the custom field, touch the

Enter Custom Field box.
The next screen displayed is Enter

Custom Field. Use the keyboards
to enter a custom field
(e.g., Physician Name). Touch
Enter to return to the Custom
Settings screen.

Screen.
5-8
5 Instrument Set Up
Touch the round button next to

Enabled (on) to highlight and
activate this custom setting.
Touch the round button next to

Disabled (off) to deactivate the
custom setting.
Touch Previous to scroll back

through custom setting screens to
review.
Touch Next to proceed to the Input

Settings screen which will provide
a list of the selections made in
Custom Set Up.
Touch Done to confirm and return

to the Choose Settings screen.
5-9
5 Instrument Set Up
Managing Urine Colors
The following sections describe how

to customize and set urine color
choices and urine clarity for Siemens
strip tests. When you print patient
test results, you can include urine
color, clarity, or color and clarity in
the printout. Urine color and clarity
are optional; you can choose not to
print these parameters. Urine color
and clarity are available only in Full
Test or Custom mode.
Setting and Customizing Urine

Colors
You can choose from one of 10

instrument-provided colors and add
up to 4 customized colors to patient
test results.
To include instrument-provided
colors, perform the following steps:
1. At the Select screen, touch
Instrument Set Up.
The Choose Settings screen
displays.
2. Use the arrow keys to select
Operator and Patient
information.
3. Touch Select.
The Input Settings screen
displays.
4. Touch Custom Set Up.
5. Touch Next.
The Custom Settings-Operator
screen 1 of 5 displays.
6. Touch Next 3 times.
The Custom Settings-Sample
Appearance screen 4 of
5 displays.
5-10
5 Instrument Set Up
7. Touch Edit colors.

The Sample Appearance-Select
colors screen 1 of 3 displays.
8. To choose colors, touch the
button for the color you want.
To remove a selected color,
touch that color button again.
9. Touch Next.
10. To choose colors, touch the
button for the color you want.
11. Touch Next.
The Input Settings-Confirmation
screen displays.
13. Touch Done twice to return to
the Select screen.
Adding Customized Colors
To enter up to 4 custom colors,

perform the following steps:
1. At the Sample Appearance-
Select colors screen 3 of 3,
touch Enter custom color 1
(2, 3, or 4) corresponding to
each custom color.
2. Enter the custom color.
Use the alpha keyboard to
enter text.
To enter numeric text, touch
123.
NOTE: The maximum number of

characters for each color is 10.
5-11
5 Instrument Set Up
3. Touch Enter.
CAUTION
Do not edit a custom color that
already exists because doing so
deletes all patient records stored on
the system.
If a custom color exists, the

Sample Appearance screen
displays.
Touch Yes, to edit that custom
color and delete all records.
Touch No, to return to the
Sample Appearance Select
Colors screen 3 of 3.
The Input Settings-Confirmation
screen displays.
the Select screen.
Managing Strip Lot Number and

Expiration Date
You can enter the strip lot number

and expiration date and associate
this information with each patient
record. Once entered, the
information is retained for the next
test, or you can enter a new lot
number and expiration date.
You can set the instrument to
prompt for new strip information or
use the information from the last
strip before each patient test.
5-12
5 Instrument Set Up
Intrument Settings
Setting Strip Information Prompt
To set the prompt for strip

information, perform the following
steps:
Instrument Set Up.
displays.
Instrument Settings.
3. Touch Enter.
The Instrument Settings screen
displays.
Urinalysis Test Settings.
5. Touch Select.
The Urinalysis Test Settings
screen displays.
6. Touch Next.
The Urinalysis Test screen
displays.
7. To prompt for strip information
before each test, touch
Enabled.
To bypass a prompt to enter
strip information before each
test, touch Disabled.
8. Touch Done 3 times to return to
the Select screen.
5-13
5 Instrument Set Up
Date and Time Settings
The date and time are displayed on

the Select screen and are recorded
with test results.
The format of the date and time are

displayed along with specific date
and time values.
If the date and time values are

incorrect, use the up and down
arrow buttons to adjust the date
and time to the correct values.
Touch AM or PM if you are in the
12-hour time format. Touch Set to
confirm your choices and move to
the next screen.
If the format is not correct for your

workplace, for example, you prefer
DD-MM-YY to MM-DD-YY or
24-hour clock to 12-hour clock,
touch Choose Format.

Choose Format. Touch the round
button that corresponds to your
choice of a date format and a time
format. Touch Done to return to
Set Date & Time.
If the date and time are in the

format which you need, select
Done.
5-14
5 Instrument Set Up
The AM and PM selections will

not be available if the time is in the
24 hour format.
The Set Date & Time display will

show the date and time in the
formats selected. Select Set to
confirm your choices and return to
the Choose Settings screen.
5-15
5 Instrument Set Up
Test Sequence Number
Test Sequence Number
The test sequence numbers run

from 0001 to 9999 and can be
reset. The screen shows the next
test number.
Touch the Reset to 0001 round

button if you would like to reset the
numbers to start at 0001 for the
next test.
Touch Done to confirm the reset or

to leave the screen if you have not
selected the option to reset the
number. You will return to the
Choose Settings screen.
5-16
5 Instrument Set Up
Instrument Settings
Instrument Settings
This section has a series of

screens which control the way in
which the Clinitek Status+ analyzer
displays information and operates.
There are 8 Instrument Setting items.
Results Format
System Settings
Display Contrast
Connectivity
Select Urinalysis Test
Authorized Operator
Printer Settings
QC Settings
Use the up and down arrows to highlight

a setting item and touch Select.
Results Format
This allows you to select the format
in which you would like the results
to be displayed and printed.
Choose Format
Screen 1 of 2
Units Selection – allows you to
select the format in which you
would like results by touching the
round button next to the
appropriate type of format.
NOTE: Nordic units are only

available in English and Swedish. If
you set the language to Chinese,
this screen does not display, as only
SI units are available in Chinese.
5-17
5 Instrument Set Up
Instrument Settings
Plus System – select Enabled

(on) if you wish to have results
shown in the Plus System. You will
also see in Appendix B that results
can be recorded in the Plus System
(which uses “+” symbols) instead
of clinical units such as mg/dL
(mmol/L). In some languages there
is no difference between the normal
system and the Plus System.
Screen 2 of 2
Mark Positive Results – allows
you to choose whether positive
results should be marked with an
asterisk (see Appendix B for results
to be shown as positive).
Touch the round button next to Yes

to mark and record positive results.
These will be marked on the
display, on a printout and when the
data is transferred to a host
computer.
Touch No and positive results will

not be marked.
Touch Done to enter your choice

and return to Instrument Settings.
5-18
5 Instrument Set Up
Instrument Settings
System Settings
This allows selections regarding the
printer, power and sound.
System Settings
Screen 1 of 2
Printer – allows you to select the
preferred printing option by
touching the round button.
Automatic – Results for

each test will be printed
automatically when the test
is complete.
Manual – Test results will

not be printed automatically.
They can be printed by
touching the Print selection
area on the Results
screen.
Off – Test results will not

be printed.
Power Save – allows you to enable

and disable this feature. If the
instrument is powered from an
electrical outlet and is not used for
5 minutes, you may choose to have
the test table retract and the
instrument power down. When it is
powered by batteries, Power Save
is always enabled and it will power
down after 5 minutes of non-use.
Touch the Enabled (on) to activate
or Disabled (off) if the Power Save
mode is not desired.
5-19
5 Instrument Set Up
Instrument Settings
Screen 2 of 2
Sound – allows you to adjust the
sound by highlighting and selecting
a level.
Sound on – The instrument
will use a range of audible
tones.
Sound off – No audible

tones will be made by the
instrument.
Key clicks only – Audible

clicks will be heard when
the user touches an active
button or key.
Display Contrast
This allows the contrast of the
display to be increased or
decreased to suit the work area in
which it is being operated. Use the
up and down arrows to sample the
contrast settings and touch Select
to set and return to the Instrument
Settings screen.
5-20
5 Instrument Set Up
Instrument Settings
Connectivity
You can connect the instrument to
a PC or host computer, or, if you
have a Clinitek Status connector, to
an LIS using an Ethernet or
wireless network. If you are using
the connector, refer to the
Clinitek Status Connect System
Operator's Guide for more
information.
Allow results to be sent to PC

If enabled, the system
automatically sends both new and
recalled patient tests to a host or
LIS.
To automatically send new and

recalled patient results to the LIS or
a PC directly connected to the
system, touch Enabled.To prevent
sending new and recalled patient
results to the LIS or PC, touch
Disabled.
NOTE: If there is no connector,

Siemens recommends setting the
connector to Disabled setting.
Setting the connector to the
Enabled setting without a connector
may prevent communication with
an external system.
5-21
5 Instrument Set Up
Instrument Settings
Store instrument serial number

in patient records
Touch round button of either Yes or
No depending on whether you
choose to include the serial number
of your Clinitek Status+ analyzer as
part of the patient results sent to
the computer.
If you have enabled the upload

capability, you will need to ensure
that the connectivity settings are
correct for the data transfer.
Touch Edit Connectivity Settings

and a series of 3 screens for
Connectivity Settings will allow
you to edit the settings.
Connectivity Settings
Screen 1 of 3
Baud rate – Touch a round button
to select the correct Baud rate and
Next to move to the next screen.
5-22
5 Instrument Set Up
Instrument Settings
Screen 2 of 3
Parity rate – Touch a round button
to select the correct Parity rate and
Next to move to the next screen.
Screen 3 of 3
Stop Bits – Touch a round button
to select the number of Stop Bits.
Select Urinalysis Test

This displays a list of some of the
Siemens Healthcare Diagnostics
urinalysis strips which can be used
with the Clinitek Status+ analyzer.
5-23
5 Instrument Set Up
Instrument Settings

scroll through the list until the type
of strip you want to use is
highlighted. Touch Select to
confirm and return to the
Instrument Settings screen.
Do not use any reagent strip

product other than what is shown
on the display. Using the wrong
Reagent Strip will give you
incorrect results.
Some strips do not appear on the

list (e.g., Clinitek® Microalbumin 2).
The analyzer will automatically identify
them through the color ID band on the
strip.
You do not need to select a type

of Clinitest® immunoassay cassette
within Instrument Set Up.
Touch Done repeatedly to return to

the main Select screen.
5-24
5 Instrument Set Up
Instrument Settings
Edit Reported Chemistries 8. Touch Next to advance to the

next screen.
This section describes how to The Reported Chemistries
include or exclude urinalysis tests screen 2 of 2 displays.
from the reported results. Tests 9. Touch the button for the test
include GLU, BIL, KET, SG, BLO, you want to remove.
pH, PRO, URO, NIT, LEU, ALB, Touch the button again to
and CRE. The default is all tests include that test.
are reported and the button is 10. Touch Done.
filled. 11. Touch Next.
12. Touch Done 3 times to return
To set up tests for urinalysis, to the Select Ready screen.
perform the following steps:
1. At the Select Ready screen, The reported results selection
touch Instrument Set Up. applies to all strip types.
displays.
3. Touch Select.
displays.
Urinalysis Test Settings.
5. Touch Select.
The Urinalysis Test screen
displays.
6. Touch Edit reported
chemistries.
The Reported Chemistries
screen 1 of 2 displays.
7. To remove a selected test from
reported results, touch the
button for that test.
To include a test in reported
results, touch that test’s button
again.
5-25
5 Instrument Set Up
Instrument Settings
Authorized Operator 2. Use the arrow keys to select

This section describes how to set up 3. Touch Select.
use of operator IDs and add, edit, or The Instrument Settings screen
delete the list of operator IDs. When displays.
enabled, the system permits only
allowed operators to perform patient
tests, QC tests (when using the
connector), recall results, or modify
system settings. Operators gain
access by entering their ID.
The Clinitek Status+ analyzer

stores 700 operators.
NOTE: The Operator ID is never

printed or displayed with patient
results. If you wish to associate the
Operator’s Name with patient
results, enable Operator Name in
Custom Settings-Operator screen
1 of 5.
CAUTION
Once the Operator ID and Operator
Name settings are made, do not
change the Operator ID setting.
If you change the Operator
ID setting, all patient results are
erased.
Setting Operator IDs
To set up operator IDs, perform the

following steps:
1. At the Select Ready screen,
touch Instrument Set Up.
displays.
5-26
5 Instrument Set Up
Instrument Settings
4. Use the arrow keys to select 3. Touch Enter.

Authorized Operator. The Authorized Operator screen
5. Touch Select. displays indicating the Operator
The Authorized operator screen ID and which functions the
displays. operator can perform.
6. To permit access only by 4. To edit this Operator ID, touch
authorized operators, touch Edit.
Enabled.
To allow all operators access to
the system, touch Disabled.
7. If you selected Enabled, see
Adding Operator IDs below to
add at least one operator.
If you selected Disabled, touch
Done 3 times to return to the
Select Ready screen.
CAUTION
If the instrument uses the operator
list sent by the LIS, do not
power down the system. If the
connector loses power, the
operator names are erased.
NOTE: The operator list sent by the

LIS overwrites an operator list
entered via the analyzer.
Adding Operator IDs
To add operator IDs, perform the

following steps:
1. At the Authorized operator
screen, touch Add operator.
2. Enter the new Operator ID.
Use the alpha keyboard to enter
text.
5-27
5 Instrument Set Up
Instrument Settings
5. To edit which functions this Viewing, Editing, Printing, and

Operator ID can access, touch Deleting Operator IDs
Edit.
The Authorized Operator- You can view, print, or delete the
Operator access screen 1 of 2 entire operator list or edit individual
displays. operators.
6. To allow this operator to run
patient tests, touch Enabled. NOTE: If you delete the entire
To prevent patient tests, touch operator list, ensure that
Disabled. authorized operators is Disabled.
7. To allow this operator to run See Setting Operator IDs above.
QC tests, touch Enabled.
To prevent QC tests, touch
Disabled.
8. Touch Next.
The Authorized Operator-
Operator access screen 2 of
2 displays.
9. To allow this operator to recall
results, touch elect Enabled.
To prevent recall results, touch
Disabled.
10. To allow this operator to set up
the instrument, touch Enabled.
To prevent instrument setup,
touch Disabled.
11. Touch Done twice.
Operators list screen displays.
12. Touch Exit.
to the Select Ready screen.
5-28
5 Instrument Set Up
Instrument Settings
At the Authorized operator screen, NOTE: Enabling the instrument

perform the following steps: password restricts access to
1. To delete the entire operators Instrument Setup to those who
list, touch Delete operators list. know the password. If both
The Delete operators list caution Operator ID and password are
screen displays. enabled, the Operator ID has
2. To delete, touch Yes. priority.
To keep the operators list,
touch No.
If you selected No, the
Authorized operator screen
displays.
If you selected Yes, go to Step 8.
3. To edit or view the operators list,
touch View operators list.
Operators list screen displays.
4. Use the arrow keys to select the
operator you want to delete or
edit.
5. To delete that operator, touch
Delete entry.
To edit or delete that operator,
touch Select.
The Authorized operator screen
displays.
Refer to Adding Operator IDs
above, Step 6.
6. To print all operators, touch
Print.
NOTE: The system prints the first

100 operators listed alphabetically.
7. To return to the Authorized

operator screen, touch Exit.
8. Touch Done 3 times to return to
the Select Ready screen.
5-29
5 Instrument Set Up
Instrument Settings
Printer Settings 6. To select options, for example

Operator Name, Serial
This section describes how to Number, Patient Name, or
customize the printed test results. Patient ID to include in the
printout, touch the option
Customizing the Printout button.
You can customize the test results

printout by including or excluding:
Operator name
Patient name
Patient ID
Instrument serial number
Urine color
Urine clarity
Up to 2 header lines of
customized alphanumeric text
To customize the printout, perform

the following steps:
1. At the Select Ready screen,

touch Instrument Set Up.
displays.
3. Touch Select.
displays.
Printer Settings.
5. Touch Select.
The Printer Settings-Included
in print-out screen 1 of 4
displays.
5-30
5 Instrument Set Up
Instrument Settings
To remove a selected option,

touch that option button again.
7. Touch Next.
The Printer Settings-Included in
print-out screen 2 of 4 displays.
8. To select options, for example,
Color, Clarity, or Custom
Information to include in the
printout, touch the option button.
To remove a selected option,
touch that option button again.
9. Select Next.
The Printer Settings-Set Up
Custom Header screen 3 of 4
displays.
10. To include a custom header in
the printout, touch Enabled.
To exclude a custom header,
touch Disabled.
11. To edit or create line 1 of a
custom header, touch Enter
Line 1.
The Custom Header screen
displays.
12. Enter custom header text.
Use the alphabetic keyboard to
enter text.
13. Touch Enter.
The Printer Settings-Set Up
Custom Header screen 3 of 4
displays.
14. To edit or create line 2 of a
custom header, touch Enter
Line 2.
NOTE: Each custom header line

accepts up to 24 alphanumeric
characters.
5-31
5 Instrument Set Up
Instrument Settings
15. Touch Next.

The Printer Settings screen 4
of 4 displays.
16. To print to the internal printer,
touch Internal printer.
To print to an external printer,
touch External printer.
17. If you selected Internal printer,
to print sample interference
notes, touch Enabled.
To disable printing sample
interference notes, touch
Disabled.
NOTE: If you select External

printer, sample interference notes
are automatically sent to the
printer.

to the Select Ready screen.
NOTE: To use an external printer,

you must connect and enable the
Clinitek Status connector.
Quality Control
For QC instructions, refer to the

Operator’s Guide.
5-32
5 Instrument Set Up
Restore Default Settings
Restore Default Settings
This option lists the analyzer’s

original settings.

view the default settings.
Touch Restore in order to return

the analyzer to the settings listed.
Touch Yes to confirm your decision

or No to maintain the current
settings of your analyzer. You will
then return to the Restore screen.
Select Exit to return to Choose
Settings.
When the original settings are

restored, all results and patient
data will be deleted from the
memory.
5-33
5 Instrument Set Up
Diagnostics
Diagnostics
This option lists 7 diagnostic tests

which can be conducted.
Display
Touch Screen
Printer
Test Table
Light Source
Electronics
Check Cassette
These diagnostics tests should
only be conducted when instructed
by your local representative. The
representative will lead you through
the test procedures (see Appendix
A for Local Technical Support
5-34
5 Instrument Set Up
Sample Notes
Sample Interference Notes
To include Sample Interference

Notes, perform the following steps:

Instrument Set Up.
The Choose Settings screen displays.
Sample Notes.
3. Touch Select.
The Notes Settings screen displays.
4. To enable Sample Interference
Notes, touch Enabled.
To disable Sample Interference
Notes, touch Disabled.
the Select screen.
5-35
5 Instrument Set Up
System Information
This screen has information about

your analyzer.
Touch System Configuration to

view details of the current system
configuration. This screen will show
the current settings for all the items
which can be changed within the
Input Settings and Instrument
Settings screens. Scroll through
the list using the up and down
arrows to view the details and print
the information if required.
If the printer paper roll needs

replacing, Print will be disabled and
you will be able to select Help to
view instructions on replacing the
printer paper (if you require further
instruction see page 1 5, Loading the
Printer Paper or Label Roll).
Select Done once to return to

System Information screen and a
second time to return to Choose
Settings screen.
5-36
5 Instrument Set Up
System Information
This completes the settings and

choices within Instrument Set Up.
Touch Done to return to the main
Select screen.
5-37
5-38
6 Recall Results
Patient Results
Patient Results
Recall results enables you to

search, view, and print patient test
results. These results are stored on
the analyzer. If you are using the
Clinitek Status connector, you
can also recall QC results.
At the Select Screen, touch Recall

Results button.

Select Test Results.
The test results are in chronological

order. The most recent test result is
displayed at the top of the screen
and is highlighted.
Use the up and down arrow keys to

scroll through the list of patient
tests and highlight the patient you
would like to recall.
To view details of a patient result,

touch the Select button.

sent to the connected computer if
this option is set up in the analyzer.
so the results are automatically sent
to a computer see Section 5,
Instrument Set Up.
6-1
6 Recall Results
Patient Results
The first page of the patient’s

results is displayed on the screen.
If more than one page of results

exists for the patient, then the More
button will be present on the
screen.
If you would like to print the results,

touch the Print button. Any
information that was entered in
regard to the patient will be
included on the printout.
When you are finished viewing the

patient’s results, touch Done.
You will return to the Select Test

Results screen. Press Exit to
return to the main Select screen.
6-2
6 Recall Results
Sending Data to a PC
Sending Data to a PC
To send data to a computer; if a

computer has been connected to the
analyzer, all results can be sent to the
computer by touching the Send all
data button.
If you are using a Clinitek Status

connector, refer to the
Operator's Guide.
6-3
6-4
7 Troubleshooting
General Information Advisory Messages

Your Clinitek Status®+ analyzer will Errors of less importance will be
operate properly if you follow the presented via a message on the
directions for using and cleaning main Select screen when this
the instrument. screen is next displayed. When you
have taken corrective action, the
Error Messages message will be removed from the
Error messages will be displayed to display. If more than one of this
help you when the Clinitek Status+ class of error occurs, clearing one
analyzer detects something which message will enable the next to be
needs your attention. The format of displayed in order of importance to
this advisory information depends a user.
upon the importance of the
problem and the mode in which the Results Alert
instrument is being used. If an error occurs during testing and
the test cannot continue because of
To correct an error, see the List of the error, this will be presented via
Errors and Advisory Messages located the Results Alert screen. This will
at the end of this section.
provide details of the error and
show that the test has been
Errors which Disable the cancelled. The test table will be
Instrument extended so that the urinalysis strip
If the error is one which prevents or Clinitest® cassette can be
the instrument from being used, all removed.
selection areas on the screen will
be disabled. Taking the corrective
action shown will remove the error
alert screen and allow you to use
the instrument.
Other Errors
There are certain errors which need
to be corrected to enable testing of
samples but do not prevent other
instrument functions from being
used. You will need to carry out the
corrective action to enable testing.
7-1
7 Troubleshooting
Battery Power Icon Dashes may appear next to Color
and Clarity on test result printouts.
This occurs when the instrument is
powered by batteries. Color and
The battery icon indicates the Clarity are selected in the
power level of the battery. Power Instrument Set Up, but no
can be reduced while testing selections have been recorded on
continues, with an advisory the Select Appearance screens
message displayed on the main before time-out.
Select screen. If battery level falls
too low to power the analyzer, all The time-out on these screens is
selection areas on the display will designed to ensure that battery life
be disabled until the batteries are is preserved. The Color and Clarity
replaced (if you require detailed description may be added to the
instructions regarding how to printout in writing if needed.
change the batteries see Section 9,
Cleaning and Maintenance). Irregular or Slow Movement of
Test Table
Paper-out Icon If movement of the test table is
irregular or slow, this may be
caused by:
A paper-out icon appears in the top a) heavy buildup of dried urine on

of the title bar when the printer the test table. Clean the test table
paper/label roll needs replacing. and insert as described in
An advisory message will be Section 9, Periodic Cleaning of Test
displayed on the main Select Table.
screen. Replace with new paper or
label roll as instructed in Section 1, b) low battery power. Replace the
Loading the Printer Paper or Label batteries as described in Section 9,
Roll. Cleaning and Maintenance.
Dashes in Displays
Dashes are displayed in the
Results screens and on printouts
when no text has been entered for
a field enabled in Instrument Set
Up.
7-2
7 Troubleshooting
Calling for Assistance Warranty

If your Clinitek Status+ analyzer is Your Clinitek Status+ analyzer has
displaying corrective actions for a a one-year warranty period. This
detected problem, please carry out warranty is designed to protect you
the displayed instructions before from the cost associated with
calling for assistance. If this does repairing systems that exhibit
not correct the problem or no malfunctions due to defects in
instructions are displayed, contact materials and/or workmanship
your local technical support during the warranty period.
provider (for contact information
please see Appendix A, Local The warranty period commences
Technical Support Providers and from the date that the instrument is
Distributors). received at your location. Use the
Warranty Registration Card
If you are calling for assistance with provided with the instrument to
a displayed error, please have the register your warranty.
following items ready (this will
assist your local representative to To obtain assistance during the
deal with your inquiry as quickly as warranty period, please contact
possible). your local technical support
a) Error number provider or distributor.
b) Completed Problem
Checklist (found at the end
of this section).
For customer support, please

contact your local technical support
provider or distributor (for contact
information please see Appendix A,
Local Technical Support Providers
and Distributors).
7-3
7 Troubleshooting
Lists of Errors and Advisory Messages
Clinitek Status+ Analyzer: List of Errors and Advisory Messages
Error Code Description Action

E01 Low battery power Replace the batteries: a) To view instructions
on the display, touch the Error Report selection
area, or b) To use the instructions in this
manual, see page 9 7, Changing Batteries.
E02 Failure of Contact your local representative (contact

calibration data information is given in Appendix A).
E10 or E48 Loss of test results 1. Switch the instrument off by pressing the
on/off button for 2 seconds. 2. Switch the
instrument on again by pressing the on/off
button. 3. Repeat the test.
E11 Failure of test table 1. Make sure that the test table is in place.
Move the test table in or out of the instrument
slightly to reposition the test table. 2. If the
error remains, with the instrument powered
on, unplug the power cord from rear of
instrument and plug back in. Turn instrument
on by pressing the gray power button. 3. If the
error remains with the test table in place,
contact your local representative (contact
information is given in Appendix A).
E12 Failure of LED Contact your local representative (contact

E20 Failure of clock Contact your local representative (contact

E23 Low battery power Replace the batteries: a) To view instructions

on the display, touch the Error Report
selection area, or b) To use the instructions in
this manual, see page 1 2, Installing Batteries
and/or page 9 7, Changing Batteries. If the
battery level becomes too low to power the
instrument, Error Code E01 will be displayed.
E24 No printer paper Replace the printer paper a) See instructions

on the inside of the printer paper compartment
cover, or b) To view instructions on the display,
touch the Error Report selection area, or c) To
use the instructions in this manual, see page
1 4, Loading the Printer Paper or Label Roll.
7-4
7 Troubleshooting
E25, Failure of automatic Clean the calibration strip. If the error remains
calibration after cleaning, contact your local representative
E64 or
(contact information is given in Appendix A).
E65
E27 Set Up failure 1. Switch the instrument off by pressing the
on/off button for 2 seconds. 2. Switch the
instrument on again by pressing the on/off
button.
E28 Printer error Lift the printer cover and push the paper
holding arm back into position (see page 1 5,
Loading the Printer Paper or Label Roll for
location of paper holding arm).
Ensure that the strip type selected in Instrument Set
E50 Incorrect strip type
Up is being used (see 5 24, Select Urinalysis Test).
or tilted strip
Check that the strip is placed correctly on the test
table insert. If the correct type of strip is being used
and the strip is placed correctly, check the
instrument operation by running another test using:
a) a yellow and clear sample, or b) Chek Stix® (see
page 8 1, Quality Control Testing).
E52 Invalid barcode Repeat the test using the correct Siemens
cassette.
E53 Strip Test Repeat the test using the Cassette Test
selected but routine (see page 4 6 or 4 19).
cassette detected
E54 Cassette Test Repeat the test using the Strip Test routine
selected but strip (see page 4 1 or 4 11).
detected
E56 Incorrect size test Repeat the test using the correct test table
table (see page 4 1).
E57 Missing strip or Repeat the test ensuring that the strip or
cassette cassette is positioned on the test table (see
page 4 1 or 4 6 for strip or cassette testing).
7-5
7 Troubleshooting
E58 Misplaced strip Repeat the test ensuring that the strip is
correctly positioned on the test table (see
page 4 3). If error remains and you are testing
a urine dip strip, examine the test table insert
to insure that the small, white line located near
the tip of the strip (on strip side of insert) is
present and not damaged. If this line is
damaged or missing contact your local
representative (contact information is given in
Appendix A).
Inverted strip Repeat the test ensuring that the strip is
E59
positioned on the correctly positioned on the test table (see
test table page 4 3).
E60 Tilted strip Repeat the test ensuring that the strip is
page 4 3).
E61 Dry strip Repeat the test ensuring that the strip has been
in contact with the sample (see page 4 2).
E62 Light Ingress Contact your local representative (contact

E63 Failure to find end Repeat the test ensuring that the strip is
of strip
page 4 3).
E67 or Insufficient sample A sample flow issue with the cassette test may
have been detected. One or more of the test
E68 indicator lines may be missing or indiscernible
from the background, or not enough sample
was applied to the cassette. Repeat the test
ensuring the pipette is correctly filled and the
correct volume of sample is dispensed into the
well of the cassette (see page 4 8).
Strip quality When performing the quality check, the strip

E69 quality failed. This means that the strip was not
problem
shipped or stored in the proper humidity,
temperature, or light conditions.
1. Remove the defective strip and discard.
2. Repeat the test ensuring the strip meets
quality requirements.
3. Repeat the test using a new test strip.
7-6
7 Troubleshooting
E03, E04, Failure of Contact your local representative (contact

E05, E06, computer software information is given in Appendix A).
E07, E08,
E21, E22,
E90, E91,
E92 or E93
7-7
7 Troubleshooting
Problem Checklist
Clinitek Status+ Analyzer: Problem Checklist
Serial Number ___________________________
Installation Date___________________________
YES NO
1. Have you reviewed the error messages on pages 7-4
to 7-7?
2. Please record any error messages that have been

displayed:
________________________________________________________________
________________________________________________________________
________________________________________________________________
3. Does the test table move out to the “load” position

when the analyzer is first turned on?
4. If Question #3 is NO –
Is the power cord plugged into a live
electrical outlet, into the transformer, and
then into the analyzer?
If using batteries, are they fully charged and
correctly placed in the analyzer?
5. Does the display show the Select screen or the

Results screen as expected?
6. Does the test table move into and out of the

analyzer?
7. Does a quality control solution give the expected

result?
7-8
7 Troubleshooting
Problem Checklist
YES NO
8. Is the name of the Siemens Healthcare Diagnostics
urinalysis strip or Clinitest immunoassay cassette
shown on the display the same as the product being
used?
9. Does the display or printout show the correct test

names and expected results?
10. Is the white calibration bar on the test table dirty,

scratched, or damaged?
11. Additional problem observations, please describe:

____________________________________________________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________________________________________________________________________________
______________________________________________
7-9
7-10
8 Quality Control Testing
If you are using a Clinitek Status

hCG Please refer to the
connector, refer to the Clinitest® hCG cassette test package
Clinitek Status Connect System insert for the appropriate quality
Operator's Guide. control material.
Quality Control for Urinalysis

Strip Testing
Test negative and positive controls

whenever a new bottle of reagent
strips is first opened.
Water should NOT be used as a

negative control. Contact your
Siemens representative for
additional information on performing
QC testing.
Refer to the quality control

product insert for expected values for
each analyte.
Quality Control for Cassette

Testing
It is recommended that quality

control specimens be used with
each new reagent box opened.
Water should NOT be used as a

negative control. Contact your
Siemens representative for
additional information on performing
QC testing.
8-1
8-2
9 Cleaning and Maintenance
Cleaning
Cleaning
The test table insert and the test

table should be kept clean if the
analyzer is to operate properly.
Do not autoclave the test table
or test table insert.

Routine Cleaning of Test Table

Insert
1 Remove insert and thoroughly

clean.
2 Rinse both sides of the table

insert under running water.
3 Dry and replace insert.
Periodic Cleaning of Test Table

when Required
1 Remove the test table by

pulling it slowly out of the
analyzer. Lift the test table
insert from the test table, drain
the drip tray if necessary.
2 Wet a cotton-tipped stick with

water and carefully clean test
table (except for white
calibration bar).
9-1
Cleaning
3 Dry the test table thoroughly

(except for the white calibration
bar) with a soft cloth or lint-free
tissue.
Care should be taken not to

scratch the white calibration bar.
Instructions for cleaning the white
calibration bar are given later in this
section.
4 Reinsert the test table into the

analyzer by holding the table at
the end opposite the white
calibration bar, with the white
calibration bar facing upwards.
Push the test table firmly but
slowly, just over halfway into
the analyzer.

5 Replace the test table insert.
9-2
Cleaning
Disinfecting the Test Table and 2 Place the insert and/or test
Insert table into the solution, making
sure the white calibration bar on
1 Prepare one of the following the test table remains above
solutions in a tall, narrow the liquid level.
container (e.g., empty Multistix®
Be sure the solution does not
bottle) to a depth of about
come in contact with the white
4 inches (10 cm): calibration bar. Do not cover the
container while the test table is
• Presept, Cidex, soaking.
Theracide and Amphyl
solutions - prepare 3 Soak the table and insert for a
according to product minimum of 2 minutes and
directions. maximum of 10 minutes. Do not
soak longer than 10 minutes.
• Household Bleach (5%
sodium hypochlorite) – this 4 Rinse the test table and insert
can be used either full thoroughly with water.
strength or dilute with water
to as much as 1:20 5 Dry with a soft cloth and
(i.e., mix 5 mL bleach with replace test table and table
95 mL water for a total of insert in the analyzer (as
100 mL). described on the previous
Rinse away all bleach page).
residue, as remaining bleach
will affect several of the reagent
pad chemistries.
• Isopropyl Alcohol (70% to

85%) - this can be used full
strength.
Any solutions other than those

listed above may damage the test
table and insert.
9-3
Cleaning
To enable your Clinitek Status®+

analyzer to perform as intended
and provide reliable test results, it
is recommended that you regularly
check the white calibration bar on
the test table, and always check it
after a strip jam.
In normal use, the white calibration

bar should not become dirty or
discolored.
biohazardous materials. White
Calibration Bar
Cleaning the White Calibration Bar
1 Remove the insert from the test

table.
2 Remove the test table by pulling

it slowly out of the analyzer.
3 Check the white calibration bar

on the test table for dirt or
discoloration.
9-4
Cleaning
4 If the white calibration bar is

clean and unmarked, replace
the table into the analyzer by
holding the table at the end
opposite the white calibration
bar, with the white calibration
bar facing upwards. Push the
test table firmly but slowly, just
over half way into the analyzer.
5 Replace the test table insert.
6 If the white calibration bar is

dirty or discolored, gently wipe
and clean it with a new cotton-
tipped stick or lint-free cloth
wetted with distilled water.
Care should be taken not to
scratch the white calibration bar.
Solvents of any kind must not be
used to clean the bar.
7 Allow the calibration bar to air

dry and then inspect the surface
for dust, foreign material,
scratches or scuffs. If the
calibration bar cannot be
cleaned or is still marked, obtain
a new test table.
8 Reinsert the test table as

described earlier in point 4.
9-5
Cleaning
Always keep the outside of the

Clinitek Status+ analyzer clean and
free of dust.
1 Turn the analyzer off by

pressing the on/off button for
2 seconds.
2 Wipe the outside (including the

display) with a damp (not wet)
cloth and a mild detergent.
Do not use any type of

solvent, oil, grease, silicone spray,
or lubrication on the analyzer.
Do not spray the glass cleaner

directly onto the screen. Do not use
laboratory wipes, such as Kimwipes,
since they may scratch the screen.
Care should be taken to avoid

liquid from entering the printer
compartment.
The display may be disinfected

using the same solutions as for the test
table (see earlier in this section). Wipe
the solution on and allow to remain for
10 minutes. Wipe clean using a clean
cloth dampened with water, then dry.
9-6
Changing Batteries
Changing Batteries
Battery-Powered Operation
The Clinitek Status+ analyzer is
designed to let you carry out the
maximum number of tests
(approximately 100) from a set of
batteries. To achieve this, the
Power Save feature is always
activated when the instrument is
powered by batteries.
If the instrument is not used in

5 minutes when battery-powered, it
will automatically power down.
A battery power icon will be shown

in the top right corner of the title bar
when the analyzer is being
powered by batteries. The number
of segments displayed represents
the amount of power remaining in
the batteries.
When power is reduced but testing

can continue, an advisory message
will be displayed on the main
Select screen.
NOTE: The printout may be lighter

if the analyzer is using battery
power.
If you do not change the batteries
and the level becomes too low to
power the analyzer, the error will
become critical and all selection
areas on the screen will be disabled
until the batteries are replaced.
9-7
Changing Batteries
Remove the test table from the

analyzer. Next, place the analyzer
on its side and remove the battery
cover by pressing down on the tab
and pulling out. Remove current
batteries. Place 6 new AA-size
batteries into the analyzer. Replace
the battery cover and turn the
instrument back onto its base.
9-8
10 Appendices
Appendix A: Local Technical Support Providers and Distributors
Appendix A: Local Technical Support Providers and Distributors
Legal Information
To contact the legal representative for Siemens Healthcare Diagnostics
within the European community, contact the Siemens Authorized
Representative. To order supplies or replacement parts, or to obtain
service, contact your local technical support provider.
Siemens Healthcare Diagnostics Authorized Representative

Frimley, Camberley, GU16 8QD UK
Origin: UK
Tarrytown, NY 10591-5097 USA

Frimley, Camberley, GU16 8QD, UK

511 Benedict Avenue
Tarrytown, NY 10591 5097 USA
Siemens Healthcare Diagnostics Pty Ltd

885 Mountain Highway
Bayswater Victoria 3153
Australia
www.siemens.com/diagnostics
10-1
10 Appendices
Appendix B: Tables of Results
Table 1 English – Conv.

Units – Conventional
Reagent Strip Tests
Test Abbreviation Units Reported Results

Normal System Plus System
Glucose Negative 500 Negative 2+
GLU mg/dL 100 >=1000 Trace 3+
250 1+
Glucose GLU mg/dL Negative 500 Negative 2+
(CT Malb 9*) 100 1000 Trace 3+
250 >=2000 1+ 4+
Bilirubin Negative Moderate Negative 2+
BIL
Small Large 1+ 3+
Ketone Negative 40 Negative 2+
KET mg/dL Trace 80 Trace 3+
15 >=160 1+ 4+
Specific <=1.005 1.020
Gravity SG 1.010 1.025 No Difference
1.015 >=1.030
Occult Blood Negative Small Negative 1+
BLO Trace-lysed Moderate Trace-lysed 2+
Trace-intact Large Trace-intact 3+
pH 5.0 6.5 8.0
pH 5.5 7.0 8.5 No Difference
6.0 7.5 >=9.0
Protein Negative 100 Negative 2+
(Multistix PRO®) PRO mg/dL 15 300 Low 3+
(CT Malb 9*) 30 1+
Protein Negative 100 Negative 2+
(All other
PRO mg/dL Trace >=300 Trace 3+
urinalysis
strips) 30 1+
Urobilinogen 0.2 4.0
URO E.U./dL 1.0 >=8.0 No Difference
2.0
Nitrite NIT Negative Positive No Difference
Leukocytes Negative Moderate Negative 2+
LEU Trace Large Trace 3+
Small 1+
Albumin 10 80
ALB mg/L No Difference
30 150
Creatinine 10 200
CRE mg/dL 50 300 No Difference
100
Albumin: <30 Normal >300 High
Creatinine Abnormal
(Clinitek A:C mg/g 30 – 300 No Difference
Microalbumin 2) Abnormal
10-2
10 Appendices

Albumin: Normal Dilute 30-300
Creatinine <30 Abnormal
(CT Malb 9*) A:C mg/g Normal >300 No Difference
High
Abnormal
Protein: Normal Dilute 300
Creatinine Abnormal
(Multistix PRO) Normal >500
P:C mg/g No Difference
Abnormal
150
Abnormal
Creatinine Normal Abnormal
(CT Malb 9*) 300 >=5000
P:C mg/g No Difference
Abnormal Abnormal
1500
Abnormal
Cassette Test
Test Abbreviation Reported Results

Human Chorionic hCG Negative hCG Positive
Gonadotropin
Borderline hCG
hCG level No Difference
Test fresh sample
in 48-72 hours
The results shown in shaded areas will be marked as positives, if “mark

positive results” is selected in Instrument Set Up. They will be marked by
asterisks when displayed, when printed and when the data is transferred
to a host computer.
* Clinitek Microalbumin 9
10-3
10 Appendices
Table 2 English – S.I.

Units – International (S.I.)
Reagent Strip Tests

GLU mmol/L 5.5 >=55 Trace 3+
14 1+
(CT Malb 9*) GLU mmol/L 5.5 55 Trace 3+
14 >=110 1+ 4+
Bilirubin Negative Moderate Negative 2+
BIL
Small Large 1+ 3+
Ketone Negative 3.9 Negative 2+
KET mmol/L Trace 7.8 Trace 3+
1.5 >=15.6 1+ 4+
Specific Gravity <=1.005 1.020
No Difference
SG 1.010 1.025
1.015 >=1.030
Occult Blood Negative Ca 25 Negative 1+
BLD Ery/µL Trace-lysed Ca 80 Trace-lysed 2+
Trace-intact Ca 200 Trace-intact 3+
pH 5.0 8.0
6.5
5.5 8.5
pH No Difference
7.0
6.0 >=9.0
7.5
Protein Negative 1.0 Negative 2+
®
(Multistix PRO )
(CT Malb 9*) PRO g/L 0.15 3.0 Low 3+
0.3 1+
Protein Negative 1.0 Negative 2+
(All other reagent PRO g/L Trace >=3.0 Trace 3+
strips) 0.3 1+
Urobilinogen 3.2 66
UBG µmol/L 16 >=131 No Difference
33
Leukocytes Negative Ca 125 Negative 2+
LEU Leu/µL Ca 15 Ca 500 Trace 3+
Ca 70 1+
Albumin 10 80
30 150
Creatinine 0.9 17.7
CRE mmol/L 4.4 26.5 No Difference
8.8
Albumin:Creatinine <3.4 >33.9
(Clinitek Normal High
Microalbumin 2) A:C mg/mmol Abnormal No Difference
3.4 – 33.9
Abnormal
Albumin:Creatinine Normal Dilute Abnormal
(CT Malb 9*) <3.4 >33.9
A:C mg/mmol No Difference
Normal High
3.4-33.9 Abnormal
10-4
10 Appendices
Test Reported Results

Abbreviation Units
Protein: Normal Dilute 33.9
Creatinine Abnormal
(Multistix PRO) Normal >56.6
P:C mg/mmol No Difference
Abnormal
17.0
Abnormal
(CT Malb 9*) 33.9 >=566
Abnormal Abnormal
170
Abnormal
Cassette Test
Test Abbreviation Reported Results
Human Chorionic hCG Negative hCG Positive
Gonadotropin
Borderline hCG
hCG No Difference
level
Test fresh sample
in 48-72 hours

to a host computer.
10-5
10 Appendices
Table 3 English – Nordic

Units – Nordic Plus System
Reagent Strip Tests

Glucose Negative 3+ Negative 2+
GLU 1+ 4+ Trace 3+
2+ 1+
Glucose Negative 3+ Negative 2+
(CT Malb 9*) GLU 1+ 4+ Trace 3+
2+ 5+ 1+ 4+
Bilirubin Negative 2+ No Difference
BIL
1+ 3+
Ketone Negative 3+ Negative 2+
KET 1+ 4+ Trace 3+
2+ 5+ 1+ 4+
Specific <=1.005 1.020
No Difference
Gravity SG 1.010 1.025
1.015 >=1.030
Occult Blood Negative 1+
BLD +/- 2+ No Difference
+/- Intact 3+
pH 5.0 6.5 8.0
pH 5.5 7.0 8.5 No Difference
6.0 7.5 >=9.0
Protein Negative 2+
(Multistix PRO®) PRO Low 3+ No Difference
(CT Malb 9*) 1+
Protein Negative 2+ Negative 2+
(All other PRO +/- 3+ Trace 3+
reagent strips) 1+ 1+
Urobilinogen 3.2 66
URO µmol/L 16 >=131 No Difference
33
Leukocytes Negative 3+ Negative 2+
LEU 1+ 4+ Trace 3+
2+ 1+
Albumin 10 80
30 150
Creatinine 0.9 17.7
CRE mmol/L 4.4 26.5 No Difference
8.8
Albumin: <3.4 >33.9 High
(Clinitek A:C mg/mmol 3.4 – 33.9 No Difference
Microalbumin 2) Abnormal
Albumin: Normal Dilute 3.4-33.9
Creatinine <3.4 Abnormal
(CT Malb 9*) A:C mg/mmol Normal >33.9 No Difference
High
Abnormal
Protein: Normal Dilute 33.9
Creatinine Abnormal
(Multistix PRO) Normal >56.6
Abnormal
17.0
Abnormal
Protein: P:C mg/mmol Normal Dilute 339
(CT Malb 9*) 33.9 >=566
No Difference
Abnormal Abnormal
170
Abnormal
10-6
10 Appendices
Cassette Test
Normal System Plus
System
Human hCG Negative hCG Positive
Chorionic hCG
Gonadotropin Borderline hCG
No Difference
level
Test fresh sample
in 48 72 hours

to a host computer.
10-7
10 Appendices
Appendix C: Specifications
Power Required Optimum Operating Temperature

110V AC ± 20%, 45 - 65 Hz Range
(US only) 22°C to 26°C (72°F to 79°F)
220V AC ± 20%, 45 - 65 Hz
(Europe only) Optimum Operating Humidity
240V AC ± 20%, 45 - 65 Hz (UK Range
only) 35% to 55% Relative Humidity
100V - 240V AC ± 20%, 45 - 65 Hz (non-condensing)
(with in-line lead) Optimum ranges insure that the
reagent results are optimized for
Battery Powered Operation performance. At temperatures
Size 6 AA alkaline batteries under 22°C (72°F), urobilinogen
and leukocyte results may be
Dimensions decreased, and at temperatures
Depth - 272 mm (10.7 inches) above 26°C (79°F), increased.
Width - 171 mm (6.7 inches)
Height - 158 mm (6.2 inches) Altitude: 2000 m (6562 ft)
Weight Installation Category: II

Clinitek Status®+ instrument only
(unpacked, without batteries or Pollution Degree: 2
power supply) – 1.66 kg (3.65 lb)
Instrument Memory
Ambient Operating Temperature 950 Patient test results
Range 200 Patient details (Patient’s Name
18°C to 30°C (64°F to 86°F) and/or Patient Identification)
Ambient Operating Humidity Safety Standards

Range The Clinitek Status+ analyzer is
18% to 80% Relative Humidity classed as a Class A computing
(non-condensing) device in accordance with Part 15
of FCC Rules.
10-8
10 Appendices
NOTE: This equipment has been The instrument is certified as

tested and found to comply with meeting the EMC requirements and
the limits for a Class A digital safety specifications of the In Vitro
device, pursuant to Part 15 of the Diagnostic Directive
FCC Rules. These limits are (98/79/EC).
designed to provide reasonable
protection against harmful
interference when the equipment
is operated in a commercial
environment. The equipment
generates, uses, and can radiate
radio frequency energy and, if not
installed and used in accordance
with the instruction manual, may
cause harmful interference to radio
communications. Operation of this
equipment in a residential area is
likely to cause harmful interference
in which case the user will be
required to correct the interference
at his own expense.
The instrument is listed by the

Underwriters’ Laboratories (UL) and
the Canadian Standards
Association (CSA) as certified and
complies with the safety standards
specified in UL 61010A-1 and
CSA-C22, No. 1010.1.
The instrument complies with the

protection requirements of
EN 61010-1,
EN 50082-1 January 1992,
EN 50081-1 January 1992,
and the safety specifications of
IEC 61010-1 A2 1995.
10-9
10 Appendices
Appendix D: Instrument Default Settings – English
Password Time Format

Password protection not set 12 hour
Input Settings Results Format

Quick Test Units Selection
Conventional
Operator Name
Disabled Plus System
Disabled
Keyboard Priority
Alphabetic Mark Positive Results
Disabled
Entry of Patient’s Name
Disabled System Settings
Printer
Entry of Patient ID Automatic
Disabled
Power Save
Include Patient’s Name or ID in Disabled
Results
Patient’s Name Sound
On
Last Operator Name
Disabled Contrast Setting
0 (zero)
Sample Appearance
Disabled Connectivity
Allow Results to be Sent to PC
Custom Data Entry Enabled
Disabled
Instrument Serial Number in
Date Format Patient Records
MM-DD-YYYY Disabled
10-10
10 Appendices
Baud Rate
115200
Parity
None
Stop Bits
1 (one)
Urinalysis Test Selected

Multistix® 10 SG
Sample Notes
Enabled
Authorized Operator
Disabled
10-11
10 Appendices
Appendix E: System Overview & Principles
Description of Optical System When using a Clinitest immunoassay

The optical system consists of six cassette, the detector will scan the
light emitting diodes, a light guide, “read area” for the test, reference
a mirror, a lens and a detector. and control lines that form after
Light from the LEDs travels along urine has been applied. The
the light guide and is reflected off reference and control lines will
the calibration bar, strip or cassette always form whereas the test line
onto the mirror. It is then directed will only form if hCG is present in
through an aperture on the lens, the sample.
from where it is focused onto the
detector. The light intensity Description of Internal Checks
detected is converted into electrical When the analyzer is first turned
impulses, which are processed by on, the instrument performs a
the instrument’s microprocessor series of electronic, signal and
and converted into clinically memory checks, as well as
meaningful results. ensuring there is sufficient battery
voltage to operate the instrument (if
When carrying out analysis on a powered by batteries).
urinalysis strip, the test table
positions strip pads in the “read Each time a urinalysis strip is read,
area”. The light reflected at specific the instrument positions the table
wavelengths (470 nm, 525 nm, correctly and checks the electronics
565 nm, 625 nm, 660 nm and and signals. It then takes reference
845 nm) from the test pad is readings off the white calibration
dependent upon the degree of color bar on the test table. The readings
change in the pad and is directly are taken at all six wavelengths and
related to the concentration of the are then used to calculate the
particular constituent in the urine. sample readings.
The analyzer’s optical system
images the entire strip (i.e., all
reagent pads at once).
10-12
10 Appendices
The table and test strip are pulled Differences between the Human
into the instrument after the correct Eye and Instrumental Optics
placement of the test strip is There are inherent differences
confirmed. The table then moves between the colors that are
completely into the instrument perceived by the human eye and
closing the shutter. All test pads are that are detected by any instrument
read simultaneously at all six optical system. The human eye is
wavelengths. The test and capable of detecting minute
reference readings are then used to differences in shade and very small
determine presence and/or amount areas of color; whereas instrument
of each constituent in the urine optical systems are less sensitive
sample. to such small changes. Conversely,
instrument optics are capable of
Each time a cassette is read, the detecting certain colors that are
instrument positions the table masked by or blended with other
correctly and checks the electronics colors to the human eye.
and signals. It then takes reference
readings of the white calibration bar For this reason, exact agreement
on the test table. The readings are between visual results and
taken at two wavelengths (525 nm instrument results might not be
and 845 nm) and are then used to found. However, agreement is
calculate the sample readings. generally within one visual color
block or reported level and is equal
The table and cassette are pulled to or better than the agreement
into the instrument where the between two visual readers.
presence of the cassette is
confirmed. The table then pulls
completely into the instrument
closing the shutter and the
cassette “read area” is scanned at
two wavelengths. The test and
references readings are then used
to determine presence or absence
of hCG the urine sample.
10-13
10 Appendices
10-14
10 Appendices
10-15
10 Appendices
10-16
10 Appendices
10-17
10 Appendices
Appendix F: Training & Educational Materials
Appendix F: Training & Educational Materials
Chek-Stix® Positive and Negative control strips are

available for use in your training program for routine urine
strip testing (for supply information see Appendix A, Local
Technical Support Providers and Distributors). Follow the
package insert for instruction on preparation and testing.
10-18
10 Appendices
Appendix G: Sample Interference Notes
Appendix G: Sample Interference Notes
Sample Interference Notes inform the user about test results that can be
affected by components detected in the urine sample.
Depending upon the strip and sample, Sample Interference Notes include
the following:
High SG may cause falsely lowered GLU results.
Elevated GLU may cause falsely lowered LEU results.
Visibly bloody urine may cause falsely elevated PRO results.
High SG may cause falsely lowered LEU results.
High pH may cause falsely elevated PRO results.
10-19
10 Appendices
Appendix H: Safety Information

Protecting Yourself from direct contact with superficial
Biohazards cuts, open wounds, and
other skin conditions that
This information summarizes the may permit absorption into
established guidelines for handling subcutaneous skin layers
laboratory biohazards. This splashes or aerosol contact
summary is based on the with skin and eyes
guidelines developed by the
Centers for Disease Control, the To prevent accidental
Clinical and Laboratory Standards contamination in a clinical
Institute, and the Occupational laboratory, strictly adhere to the
Safety and Health Administration. following procedures:
Wear gloves while servicing
Use this summary for general parts of the system that have
information only. It is not intended contact with body fluids such
to replace or supplement your as serum, plasma, urine, or
laboratory or hospital biohazard whole blood.
control procedures.
Wash your hands before
By definition, a biohazardous going from a contaminated
condition is a situation involving area to a noncontaminated
infectious agents biological in area, or when you remove or
nature, such as the hepatitis B change gloves.
virus, the human immunodeficiency Perform procedures carefully
virus, and the tuberculosis to minimize aerosol
bacterium. These infectious agents formation.
may be present in human blood Wear facial protection when
and blood products and in other splatter or aerosol formation
body fluids. are possible.
Wear personal protective
The following are the major sources
equipment such as safety
of contamination when handling
glasses, gloves, lab coats or
potentially infectious agents:
aprons when working with
needlesticks
possible biohazard
hand-to-mouth contact contaminants.
hand-to-eye contact
10-20
10 Appendices
Keep your hands away from References

your face.
Cover all superficial cuts and 1. Centers for Disease Control.
wounds before starting any Update: Universal precautions for
work. prevention of transmission of
human immunodeficiency virus,
Dispose of contaminated hepatitis B virus and other
materials according to your bloodborne pathogens in
laboratory’s biohazard healthcare settings. 1988. MMWR,
control procedures. 37:377-382, 387, 388.
Keep your work area
disinfected. 2. Clinical and Laboratory
Disinfect tools and other Standards Institute (formerly
items that have been near NCCLS). Protection of Laboratory
any part of the system Workers from Occupationally
sample path or waste area Acquired Infections; Approved
with 10% v/v bleach. Guideline - Third Edition. Wayne,
PA: Clinical and Laboratory
Do not eat, drink, smoke, or
Standards Institute; 2005. CLSI
apply cosmetics or contact
Document M29-A3. [ISBN 1-56238-
lenses while in the
567-4].
laboratory.
Do not mouth pipet any 3. Federal Occupational Safety
liquid, including water. and Health Administration.
Do not place tools or any Bloodborne Pathogens Standard.
other items in your mouth. 29 CFR 1910. 1030.
Do not use the biohazard
sink for personal cleaning
such as rinsing coffee cups
or washing hands.
Do not recap, purposely bend, cut,

break, remove from disposable
syringes, or otherwise manipulate
needles by hand. Needlestick
injuries may result.
10-21
10 Appendices
Appendix I: Clinitek Status®+ Intended Use and Indications for Use
Appendix I: Clinitek Status®+ Intended Use and Indications for Use
The Clinitek Status®+ Urine Tests performed using the

Chemistry Analyzer is a portable Clinitek Status®+ Analyzer are
easy to use analyzer. It is intended for in vitro diagnostic
designed to read only Siemens use only.
Reagent Strips for Urinalysis
and Clinitest® hCG tests. The Clinitek Status®+ Analyzer
is intended for near patient
This analyzer is intended for the (point-of-care) facilities and
measurement of the following in centralized laboratory locations.
urine: Albumin, Bilirubin, Blood
(Occult), Creatinine, Glucose,
Ketone, Leukocytes, Nitrite, pH,
Protein, Protein-to-Creatinine
Ratio, Albumin-to-Creatinine
Ratio, Specific Gravity,
Urobilinogen, and human
Chorionic Gonadotropin (hCG).
These measurements are used

to assist diagnosis in the
following areas:
Kidney Function
Urinary tract infections
Metabolic disorders
(e.g. diabetes mellitus)
Liver Function
Pregnancy
10-22
11 Index
A D
Analyzing screen Date and time
strip test, 4-4 settings, 5-14, 5-15
cassette tests, 4-11 Default
restore default settings, 5-33
B settings, 10-10
Batteries Diagnostic tests, 5-34
error messages, 7-5 display contrast, 5-20
installing/changing E
the batteries, 1-2, 9-8
troubleshooting, 7-1 Error(s)
Battery powered operation, 9-7 calling for assistance with an
Baud rate setting, 5-22 error, 7-3
Boxed areas, 2-2 dashes in display, 7-2
error codes, 7-4
C messages, 7-1
Cabling problem checklist, 7-8, 7-9
interfacing to a computer, 1-3 results alert, 7-1
Calibration, 4-3, 4-11 F
error messages, 7-4, 7-6
Cassette Full test
full test, 4-22 cassette test, 4-22
immunoassay cassette, 4-9 set up, 5-4
preparing a cassette, 4-9
testing error messages, 7-4 G
Cleaning General information, 7-1
disinfect the test table
and insert, 9-3 H
exterior cleaning, 9-6
periodic cleaning, 9-1 Help
routine cleaning, 9-1 cassette test, 4-8
Clock error message, 7-6
Connectivity, 5-21, 5-22
Custom
field entry, 5-6
information, 5-6
set up, 5-6
11-1
11 Index
I P
Icons Parity setting, 5-23
battery power icon, 7-2 Password
display icons, vii, viii, x remove password, 5-3
paper-out icon, 7-2 set password, 5-3
Instrument Patient
diagnostics, 5-34 enter new patient
error messages, 7-4 identification, 4-16, 4-17, 4-25
settings, 5-17 information, 4-15, 4-25
Interfacing to a computer, 1-3 patient identification set up, 5-7
connectivity, 5-21, 5-22 recall identification, 4-15, 4-24
Internal checks, 10-12, 10-13 Positive results marked, 5-18
Power
K inlet socket, 1-2
Keyboards on/off button, 1-8
alphabetic, 2-4 plugging analyzer in, 1-2
numeric, 2-4, 2-5 save, 5-19
set keyboard priority 5-6 supply, 1-1
Powering down, 1-8
L Powering up, 1-7
Printer
Language error messages, 7-4
select language, 5-2 loading the printer paper
or label roll, 1-5
M paper holding arm, 1-5
Mark positive results, 5-18 paper-out, 7-2
setting printing to automatic
O manual, 5-19
Printour of results
Operator full strip test, 4-21
last operator quick cassette test, 4-12
identification, 4-14, 4-22 quick strip test, 4-4
new operator identification, 4-23 Problem checklist, 7-8
set up of identification, 5-6
Optical system, 10-12
11-2
11 Index
Q Sound settings, 5-20

Specifications of instrument, 10-8
Quality control Start-up wizard, 3-1
cassette testing, 8-1 Stop bits setting, 5-23
urinalysis strip testing, 8-1 Strip
Quick test blot strip, 4-3
set up, 5-5 changing strip type, 5-23
dip strip 4-2
R holding channel, 4-3
Reagent preparing a urine strip, 4-2
select strip product 5-24 quick strip test, 4-1
Results select strip type, 5-23
choose results format, 5-18 testing error messages, 7-4
error messages, 7-4 Strip Test v
full strip test, 4-21 Supplies, ordering, 10-1
mark positive results, 5-18 Symbols, vii
number stored, 4-15 System
plus system, 5-18 configuration, 5-36
print recalled results, 6-2 settings, 5-19
quick cassette test, 4-12
quick strip test, 4-6
T
recalling, 6-1 Test table
sending results data to a PC, 6-3 irregular movement, 7-2
Round buttons, 2-2 Testing
full cassette test, 4-22
S full strip test, 4-13
Sample Interference help, 4-1, 4-8
Notes 4-5, 5-35, 10-19 prepare strip test, 4-1
Scroll arrows, 2-3 quick strip test, 4-1
Sequence number sequence number, 5-16
reset, 5-16 Touch screen
Serial number of instrument alpha-numeric keypad, 2-4
locating serial plate, 1-6 how and where to touch, 2-2, 2-3
recording serial number, 1-6 layout, 2-1
storing serial number in patient Troubleshooting, 7-1
records, 5-22
Serial port, 1-3
11-3
11 Index
U
Units
conventional units, 5-17
Unpacking, 1-1
Urinalysis test, 5-23, 5-24
Urine sample
clarity, 4-19
color, 4-18
settings, 5-8
visual appearance, 4-18, 4-19
W
Warranty, 7-3
registration card, 1-6
11-4

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134798 Rev. A, 2009 07

Clinitek, Clinitek Status, Multistix, Multistix PRO, Combistix, Uristix,

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

Siemens Healthcare Diagnostics Ltd.

The information in this manual was correct at the time of printing.

If this instrument is used in a manner differently than specified

A Brief Description ............................................................ v

1 Unpacking & Set Up ................................................. 1-1

2 Interacting with the Touch Screen .......................... 2-1

3 Start-Up Wizard ......................................................... 3-1

4 Testing ....................................................................... 4-1

6 Recall Results ........................................................... 6-1

7 Troubleshooting ........................................................ 7-1

8 Quality Control Testing ............................................ 8-1

11 Index ..................................................................................... 11-1

Your Clinitek Status®+ analyzer is a How does it work?

What about this Operator’s Bold/italic text identifies screen names.

The Operator’s Manual contains

Bold text identifies a button

Indicates that the input supply is direct current

Identifies that the instrument is type B equipment, which

Double insulated product or transformer may also identify

Identifies that the instrument is listed by Underwriters

The CE mark identifies that the product complies with the

European authorized representative

Indicates a power on/off button

Caution, consult accompanying documents

In vitro diagnostic medical device

Consult instructions for use

Indicates a serial port

This system contains certain toxic or hazardous substances or

18 Temperature limitation (18° 30° C)

100 Contents sufficient for (n) tests (100)

Indicates that this equipment is classified as Waste Electrical

Printed on recycled materials

Indicates compliance with RESY packaging standards

Keep this way up

Fragile, handle with care

Keep away from sunlight and heat

VDE Testing and Certification Institute Germany

Manufacturer’s mark (FRIWO) and manufacturing location

Manufacturer’s mark (FRIWO) and manufacturing location

Encapsulated safety isolating transformer (short circuit proof)

Positive Temperature Coefficient (PTC) A thermistor device

Thermal cut out (TCO) This safety device disconnects the

Ingress protection rating protected against the entry of solid

This symbol indicates a risk of electric shock.

Strip Test (e.g., Multistix 10SG)

Cassette Test (e.g., Clinitest hCG)

Data transfer to Personal Computer

1 Carefully remove the contents 2 Remove each of the wrappings

1 Clinitek Status®+ analyzer 4 Power Supply

2 Test table If the power cord is not the style

If you are using a reagent strip 5 Paper Roll