Bayer HealthCare Clinitek Status User manual

Operator’s Manual
132387 Rev. D, 2006-06
Analyzer
®

132387 Rev. B, 2004-10
Operator’s Manual
Analyzer

132387 Rev. D, 2006-06
© 2003 Bayer HealthCare. All rights reserved.
Clinitek, Clinitek Status, Multistix, Multistix PRO, Combistix, Uristix,
Labstix, Neostix, Clinitest and Chek-Stix are trademarks of Bayer.
Precept and Cidex are trademarks of Johnson & Johnson.
Theracide is a trademark of Lafayette Pharmaceuticals, Inc.
Amphyl is a trademark of Linden Corporation.
Kimwipes is a trademark of Kimberly-Clark.
US Pats 5,408,535; 5,477,326; 5,877,863; 6,239,445; D456,082;
D489,816
Origin: UK
The information in this manual was correct at the time of printing.
However, Bayer HealthCare 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.
Bayer Diagnostics Mfg (Sudbury) Ltd
Sudbur
y
, CO10 2XQ, UK
Bayer HealthCare LLC
Subsidiary of Bayer Corporation
Tarrytown, NY 10591-5097 USA

iii
132387 Rev. B, 2004-10
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
Inserting Test Strip Table ..................................1-3
Loading Test Table Insert ................................. 1-3
Interfacing to a Computer ................................. 1-3
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 ....................................................4-6
Full Tests ..................................................................... 4-11
Urinalysis Strip Test ........................................ 4-11
Cassette Test ..................................................4-19

iv 132387 Rev. D, 2006-06
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 ...............................................5-10
Test Sequence Number ............................................... 5-12
Instrument Settings ..................................................... 5-13
Restore Default Settings ............................................. 5-21
Diagnostics .................................................................. 5-22
System Information ..................................................... 5-23
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
Information regarding CLIA Waiver ...............................8-2
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 .................................... 10-4
Appendix C: Specifications ....................................... 10-10
Appendix D: Instrument Default Settings – English .. 10-12
Appendix E: System Overview & Principles ..............10-14
Appendix F: CLIA Waiver Performance Characteristics 10-21
Appendix G: Training & Educational Materials ..........10-23
Appendix H: Safety Information ................................ 10-24
11 Index..................................................................................... 11-1

v
A Brief Description
132387 Rev. D, 2006-06
What does the analyzer do?
Your Clinitek Status®analyzer is
a portable instrument for reading
Bayer urinalysis strips and Clinitest®
immunoassay cassettes. No special
training is needed to use this
instrument. Several different Bayer
urinalysis strips (e.g., Multistix®10
SG) can be used with the analyzer
as well as the Clinitest hCG
Pregnancy Test.
The analyzer can be set up to be
as simple or sophisticated as you
prefer. You may simply insert a
dipped urinalysis strip or a Clinitest
cassette into the analyzer and the
result will be reported (this is called
a Quick Test).
Or, you have the option to enter
an Operator ID, Patient Name and
Patient ID. This added information
will be reported along with the test
results (this is called a Full Test).
The touch screen displays
instructions and prompts you
through operation of the analyzer. In
addition, you enter information
through the touch screen.
Do I have to calibrate?
You do not have to do anything to
calibrate. The instrument performs
a system test each time it is turned
on. Then, each time a test is run,
the instrument automatically
calibrates. The white calibration bar
(on the test table) provides NIST
traceable calibration.
How does it work?
Testing starts (in the Quick Test
mode) when either the Strip Test
or Cassette Test is selected on the
main menu screen.
Touching the Strip Test key
prompts you to adjust the test table
to accept a urinalysis strip. Then
you touch the START key. You
have 8 seconds to dip the test strip,
blot the edge of the strip and place
it on the test strip table. The table is
partially pulled into the instrument
for calibration and then pulled
completely into the instrument to
read the test strip.
Touching the Cassette Test key
prompts you to adjust the test table
to accept a cassette. Then you
touch the START key. You have
8seconds to draw the sample into
a pipette and dispense it into the
sample well of the cassette. The
analyzer automatically calibrates
and then pulls the table completely
into the instrument where the
cassette is read.
In the Full Test mode for either a
Strip Test or Cassette Test, you
are prompted to enter an Operator
ID, Patient Name and/or Patient ID
prior to running a test.
A Brief Description

vi
A Brief Description
132387 Rev. D, 2006-06
How do I get results?
Results will be displayed on the
touch screen and printed (if
desired). The results can also be
transferred to a computer using a
9-pin null modem serial cable and
the RS-232 serial port on the back
of the instrument.
The analyzer stores results from
200 patient tests. You are able to
recall past patient test results on
the analyzer using the Recall
Results function.
How is the analyzer powered?
The analyzer can be plugged
into an electrical outlet for use on
the bench top, or it can be powered
by batteries and freely moved from
one testing site to another. The
batteries fit into an opening on the
bottom of the instrument.
What about this Operator’s
Manual?
The Operator’s Manual contains
the directions you need to unpack
the analyzer, use it for your daily
Bayer urinalysis and Clinitest
immunoassay testing and keep it in
good working condition.
As you read through the
Operator’s Manual, you will find
these symbols:
In the Operator’s Manual, you will
notice some text is in bold/italic or
bold.
Bold/italic text identifies screen names.
NOTES: contain useful tips
on using the analyzer. Notes
appear in italicized type.
Bold text identifies a button
(touch – sensitive area) on the
screen.
CAUTION: should be
followed carefully to ensure your
analyzer operates correctly and
is not damaged. Cautions
appear in bold type.

vii
Understanding the Symbols and Display Icons
132387 Rev. D, 2006-06
Instrument and Labeling Symbols
This section describes the symbols that appear on the exterior of the
Clinitek Status instrument, the power supply provided with the instrument,
the carton in which the instrument was delivered and the supplies of reagent
strips and cassettes which you will use with the instrument.
Indicates that the input supply is direct current
Identifies that the instrument is type B equipment, which
provides a particular degree of protection against electric shock
Identifies that the instrument is class 1 type equipment, which
has basic insulation and additional safety grounding precautions
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 device
Consult instructions for use
Understanding the Symbols and Display Icons

viii
Understanding the Symbols and Display Icons
132387 Rev. D, 2006-06
Indicates a serial port
Temperature limitation (18 - 30 C)
Contents sufficient for (n) tests (100)
Use by YYYY-MM
Catalog number
Serial number
Batch code
Biohazard
Indicates that this equipment is classified as Waste Electrical
and Electronic Equipment under the European WEEE
Directive. It must be recycled or disposed of in accordance
with applicable local requirements.
Printed on recycled materials
Indicates compliance with RESY packaging standards
Keep this way up
Fragile, handle with care
100
18
30

ix
Understanding the Symbols and Display Icons
132387 Rev. D, 2006-06
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.
Keep dry
Keep away from sunlight and heat

x
Understanding the Symbols and Display Icons
132387 Rev. B, 2004-10
Display Icons
The Bayer logo is shown in the top left of the display while some of the
system diagnostic tests are being carried out after power-up. There are
seven other icons which display in the same position 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.

1-1
1
Unpacking & Set Up
132387 Rev. D, 2006-06
Clinitek Status®analyzer
Test table
Test table insert
Power Supply
Unpacking
2 Remove each of the wrappings
and check for the following items:
1 Carefully remove the contents
of the shipping carton. Check the
carton and instrument for visible
signs of damage; if seen,
immediately contact the carrier.
4
1
5
3
2
Appendix A, Local Technical Support
Providers and Distributors).
Paper Roll
Clinitek Status®Check Cassette (not
shown)
Depending on the model you have
received, there may also be a Warranty
Registration Card, Unpacking/Setup Guide,
and/or Quick Reference Guide included.
25
6
If you are using a reagent strip
that has 4 or fewer test pads,
e.g., Uristix®4, you must use a short
test table insert. This has to be ordered
separately (for a list of suppliers see
Appendix A, Local Technical Support
Providers and Distributors).
Do not touch the white
calibration bar.
If the power cord is not the style
you need, contact your local Bayer
office (for a list of contacts see
1
Do not remove the Check
Cassette from its foil packaging. The
Check Cassette should be available
if you need to call Bayer for
assistance with an analyzer error.
Store the cassette in the pocket
located inside the back cover of your
Operator’s Manual.
Unpacking
3
4

1-2
1
Unpacking & Set Up
132387 Rev. D, 2006-06
The best temperature for using
the instrument is between 22°C and
26°C (72°F and 79°F). Do not place
the analyzer outside or near
windows, ovens, hot plates, or
radiators.
5
3
4
Set Up
Set Up
Analyzer Set Up
Place the instrument on a level
work surface where the
temperature and humidity are fairly
constant.
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.
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
AA-size batteries into the analyzer.
Replace the battery cover and turn
the instrument back onto its base.

1-3
1
Unpacking & Set Up
132387 Rev. D, 2006-06
Do not touch the white
calibration bar.
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.
Loading Test Table Insert
The test table insert adapts for use
with a Bayer urinalysis strip or
Clinitest immunoassay cassette.
One side is used for a strip test and
the other side is used for a cassette
test.
6
7
8
Set Up
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 Bayer Representative
(for a list of suppliers see
Appendix A, Local Technical
Support Providers and
Distributors).
Do not push the test table fully
into the analyzer as the test table
may become jammed and prevent
the use of the analyzer.

1-4
1
Unpacking & Set Up
132387 Rev. B, 2004-10
Analyzer Software Upgrades
From time to time Bayer HealthCare
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.
Analyzer Software Upgrades
9

1-5
1
Unpacking & Set Up
132387 Rev. B, 2004-10
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.
6. Push the paper holding arm
down in to the closed position.
7. Close the printer and paper roll
covers by clicking them into
position.
The analyzer is set up to
automatically print the results (to
turn off the automatic print function
see Section 5, Instrument Set Up).
paper holding arm
The analyzer uses ordinary
thermal paper as provided, or label
stock (for ordering information see
Appendix A, Local Technical
Support Providers and Distributors).
Set Up
10

1-6
1
Unpacking & Set Up
132387 Rev. B, 2004-10
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
Bayer office (for a contact list see
Appendix A, Local Technical
Support Providers and
Distributors).
11
Set Up

1-7
1
Unpacking & Set Up
132387 Rev. B, 2004-10
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.
Powering Up
Powering Up

1-8
1
Unpacking & Set Up
132387 Rev. D, 2006-06
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).
Do not push the test table fully
into the analyzer as the test table
may become jammed and prevent
the use of the analyzer.