Siemens Clinitek User manual

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Operator’s Manual

REF 10379682

Operator’s Manual

134798 Rev. A, 2009 07

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. How

ever, Siemens Healthcare Diagnostics continues to 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.

improve products

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 ....

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

10-10

A Brief Description

NOTE: Feature availability may vary by geography due to regulatory registration.

NOTE: Due to software changes, some screens on the instrument may appear slightly different from those in this manual.

What does the analyzer do?

Your Clinitek Status portable instrument for reading Siemens Healthcare Diagnostics urinalysis strips and Clinitest immunoassay cassettes. No special training is needed to use this instrument. Several different Siemens urinalysis strips (e.g., Multistix® 10 SG) can be used with the analyzer as well as the Clinitest hCG Pregnancy Test.

The analyzer can be set up to be as simple or sophisticated as you prefer. You may simply insert a dipped urinalysis strip or a Clinitest cassette into the analyzer and the result will be reported (this is called a Quick Test).

Or, you have the option to enter an Operator Name, Patient Name and Patient ID. This added information will be reported along with the test results (this is called a Full Test).

The touch screen displays instructions and prompts you through operation of the analyzer. In addition, you enter information through the touch screen.

analyzer is a

Do I have to calibrate?

You do not have to do anything to calibrate. The instrument performs a system test each time it is turned on. Then, each time a test is run, the instrument automatically calibrates. The white calibration bar (on the test table) provides NIST traceable calibration.

How does it work?

Testing starts (in the Quick Test mode) when either the Strip Test or Cassette Test is selected on the main menu screen.

Touching the Strip Test key prompts you to adjust the test table to accept a urinalysis strip. Then you touch the START key. You have 8 seconds to dip the test strip, blot the edge of the strip and place it on the test strip table. The table is partially pulled into the instrument for calibration and then pulled completely into the instrument to read the test strip.

Touching the Cassette Test key prompts you to adjust the test table to accept a cassette. Then you touch the START key. You have 8 seconds to draw the sample into a pipette and dispense it into the sample well of the cassette. The analyzer automatically calibrates and then pulls the table completely into the instrument where the cassette is read.

In the Full Test mode for either a Strip Test or Cassette Test, you are prompted to enter an Operator Name, Patient Name and/or Patient ID prior to running a test.

A Brief Description

How do I get results?

Results will be displayed on the touch screen and printed (if desired). The results can also be transferred to a computer using a 9-pin null modem serial cable and the RS-232 serial port on the back of the instrument.

The analyzer stores results from 950 patient tests. You are able to recall past patient test results on the analyzer using the Recall Results function.

How is the analyzer powered?

The analyzer can be plugged into an electrical outlet for use on the bench top, or it can be powered by batteries and freely moved from one testing site to another. The batteries fit into an opening on the bottom of the instrument.

the analyzer, use it for your daily Siemens urinalysis and Clinitest immunoassay testing and keep it in good working condition.

As you read through the Operator’s Manual, you will find these symbols:

NOTES: contain useful tips

on using the analyzer. Notes

appear in italicized type.

CAUTION: should be followed carefully to ensure your analyzer operates correctly and is not damaged. Cautions

appear in bold type.

In the Operator’s Manual, you will notice some text is in bold/italic or

bold.

What about this Operator’s Manual?

The Operator’s Manual contains

the directions you need to unpack

Bold text identifies a button (touch sensitive area) on the screen.

Bold/italic text identifies screen names.

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

Understanding the Symbols and Display Icons

Indicates a serial port

This system contains certain toxic or hazardous substances or elements. The environmental protection use period for this system is 50 years. The system can be used safely during its environmental protection use period. The system should be recycled immediately after its environmental protection use period has expired.

100

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

viii

Indicates compliance with RESY packaging standards

Understanding the Symbols and Display Icons

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.

Understanding the Symbols and Display Icons

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.

Unpacking & Set Up

Unpacking

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.

Clinitek Status®+ analyzer

Test table

Do not touch the white

calibration bar.

Test table insert

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).

2 Remove each of the wrappings

and check for the following items:

Power Supply

If the power cord is not the style you need, contact your local representative (for a list of contacts see Appendix A, Local Technical Support Providers and Distributors).

Paper Roll

Depending on the model you have received, there may also be a Warranty Registration Card, Unpacking/Setup Guide, and/or Quick Reference Guide included.

1-1

Unpacking & 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.

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.

Only use the power supply

adapter included with the unit.

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

Unpacking & Set Up

Set Up

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.

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.

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 Providers and Distributors).

1-3

Unpacking & Set Up

Set Up

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.

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

Unpacking & Set Up

Set Up

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.

paper holding arm

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).

The analyzer uses ordinary thermal paper as provided, or label stock (for ordering information see Appendix A, Local Technical Support Providers and Distributors).

1-5

Unpacking & Set Up

Set Up

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

Unpacking & Set 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

Unpacking & Set Up

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.

1-8

Interacting with the Touch Screen

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:

Instrument Set Up Recall Results QC Test Cassette Test Strip Test

Icon

Title Bar

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 5 sections listed on the main Select screen).

Touch Sensitive Area

2-1

Interacting with the Touch Screen

Screens

How to Touch the Screens

The screen needs to be touched lightly in the touch-sensitive area to activate a response.

Where to Touch the Screens

There are three types of areas that 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.

If a touched area does not respond as expected, slide your finger across the appropriate selection area.

Use of anything hard or pointed on the touch screen may cause damage.

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

Interacting with the Touch Screen

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

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.

Unavailable

Option

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

Interacting with the Touch Screen

Keyboards

Press to switch to

Using the Alpha-Numeric Keyboard

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.”

numeric keyboard

Data Entry Box

Back Space/ Erase key

If you require further instruction regarding how to change keyboard priority see Section 5, Instrument Set Up.

To switch between the keyboards, 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

Return to previous screen

Press to switch to alphabetic keyboard

Creates blank space

Confirm data entries

Interacting with the Touch Screen

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

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

Testing

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

Testing

Quick Tests

The next screen that appears is 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

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 nonSiemens reagent strip. Repeat the test using a Siemens reagent strip.

4-3

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

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

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.

If you require further instruction 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

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

screen for 2 minutes. After this time

the 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

Testing

Quick Tests

Cassette 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.

Please refer to the Clinitest 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 86°F) prior to testing.

Touch Cassette Test to conduct the test.

The next screen that appears is

Test Type. Touch the Clinitest hCG cassette button.

The next screen that appears is Prepare Test screen.

If you would like the steps for cassette testing to be shown on the screen then touch Help.

°C to 30°C (68°F to

hCG

4-8

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.

The next screen that appears is 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

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

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

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 the test table and cassette are pushed out of the analyzer.

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.

If the result is positive, an asterisk* will appear next to the result (if “mark positive results” was selected in Instrument Set Up).

The results will automatically be sent to the connected PC if this option is set up in the analyzer.

If you require further instruction regarding how to set up the analyzer so results are automatically printed or sent to a computer see Section 5, Instrument Set Up.

Remove the used cassette and dispose of it according to your 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

The result will be displayed on the screen for 2 minutes. After this time elapses, the display will return to main Select menu.

Testing

Full Tests

Urinalysis Strip Test

BIOHAZARD Wear personal protective

equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials.

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.

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

Testing is started from the main Select screen.

Touch Strip Test to conduct a Siemens urinalysis strip test.

4-13

Testing

Full Tests

The next screen that appears is 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.

If you require further instruction

regarding keyboard usage see Section 2, Interacting with the Touch Screen.

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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.

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Testing

Full Tests

Option 2: Enter New Patient

In order to enter the information for 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.

If you require further instruction regarding keyboard usage see Section 2, Interacting with the Touch Screen.

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Testing

Full Tests

The next screen displayed is 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.

If you require further instruction regarding keyboard usage see Section 2, Interacting with the Touch Screen.

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Testing

Full Tests

The next screen that appears is Prepare Test.

If you require further instruction regarding the procedures for running a Siemens urinalysis strip test see Section 4, Quick Tests.

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.

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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

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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.

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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 selected in Instrument Set Up).

4-21

Testing

Full Tests

Cassette Test

BIOHAZARD Wear personal protective

equipment. Use universal precautions. Refer to Appendix H for recommended precautions when working with biohazardous materials.

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.

If you require further instruction regarding the procedures for running a Siemens Clinitest immunoassay test see Section 4, Quick Tests.

Testing is started from the main Select screen.

Touch Cassette Test to conduct an hCG pregnancy test.

The next screen that appears is Operator Name.

There are two options under Operator Name: Last Operator or

Enter New Operator Name.

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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

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.

If you require further instruction regarding keyboard usage see Section 2, Interacting with the Touch Screen.

The next screen displayed is

Patient Information.

There are two options under Patient Information: Recall Patient or Enter New Patient.

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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.

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Testing

Full Tests

Option 2: Enter New Patient

In order to enter the information for 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.

If you require further instruction regarding keyboard usage see Section 2, Interacting with the Touch Screen.

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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.

If you require further instruction regarding keyboard usage see Section 2, Interacting with the Touch Screen.

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Testing

Full Tests

The next screen that appears is

Test Type.

If you require further instruction

regarding the procedures for running a Clinitest hCG cassette test see Section 4, Quick Tests.

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).

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4-28

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.

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Instrument Set Up

Language Settings

Use the up and down arrows to 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

Instrument Set Up

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.

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Instrument Set Up

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.

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Instrument Set Up

Operator and Patient Information

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

Instrument Set Up

Operator and Patient Information

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.

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Instrument Set Up

Operator and Patient Information

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).

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Instrument Set Up

Operator and Patient Information

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.

If you require further instruction regarding keyboard usage see Section 2, Interacting with the Touch Screen.

5-8

Instrument Set Up

Operator and Patient Information

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

Instrument Set Up

Operator and Patient Information

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.

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Instrument Set Up

Operator and Patient Information

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. The Sample Appearance-Select colors screen 2 of 3 displays.

10. To choose colors, touch the button for the color you want.

11.Touch Next. The Sample Appearance-Select colors screen 3 of 3 displays.

12. Touch Next 3 times. 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.

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Instrument Set Up

Operator and Patient Information

3. Touch Enter. The Sample Appearance-Select colors screen 3 of 3 displays.

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.

4. Touch Next 3 times. The Input Settings-Confirmation screen displays.

5. Touch Done twice to return to 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.

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Instrument Set Up

Intrument Settings

Setting Strip Information Prompt

To set the prompt for strip information, 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 Instrument Settings.

3. Touch Enter. The Instrument Settings screen displays.

4. Use the arrow keys to select 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.

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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.

The next screen displayed is 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.

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Instrument Set Up

Date and Time Settings

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.

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Instrument Set Up

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.

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Instrument Set Up

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.

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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.

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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.

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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.

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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.

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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

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

Instrument Set Up

Instrument Settings

Use the up and down arrows to 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 list (e.g., Clinitek The analyzer will automatically identify them through the color ID band on the strip.

You do not need to select a type of Clinitest within Instrument Set Up.

Microalbumin 2).

immunoassay cassette

the

Touch Done repeatedly to return to the main Select screen.

5-24

Instrument Set Up

Instrument Settings

Edit Reported Chemistries

This section describes how to include or exclude urinalysis tests from the reported results. Tests include GLU, BIL, KET, SG, BLO, pH, PRO, URO, NIT, LEU, ALB, and CRE. The default is all tests are reported and the button is filled.

To set up tests for urinalysis, perform the following steps:

1. At the Select Ready screen, touch Instrument Set Up. The Choose Settings screen displays.

2. Use the arrow keys to select Instrument Settings.

3. Touch Select. The Instrument Settings screen displays.

4. Use the arrow keys to select 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.

8. Touch Next to advance to the next screen. The Reported Chemistries screen 2 of 2 displays.

9. Touch the button for the test you want to remove. Touch the button again to include that test.

10. Touch Done.

11.Touch Next.

12. Touch Done 3 times to return to the Select Ready screen.

The reported results selection applies to all strip types.

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Instrument Set Up

Instrument Settings

Authorized Operator

This section describes how to set up use of operator IDs and add, edit, or delete the list of operator IDs. When 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.

2. Use the arrow keys to select Instrument Settings.

3. Touch Select. The Instrument Settings screen displays.

Setting Operator IDs

To set up operator IDs, perform the following steps:

1. At the Select Ready screen, touch Instrument Set Up. The Choose Settings screen displays.

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Instrument Set Up

Instrument Settings

4. Use the arrow keys to select Authorized Operator.

5. Touch Select. The Authorized operator screen displays.

6. To permit access only by authorized operators, touch 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.

3. Touch Enter. The Authorized Operator screen displays indicating the Operator ID and which functions the operator can perform.

4. To edit this Operator ID, touch

Edit.

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. To enter numeric text, touch 123.

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Instrument Set Up

Instrument Settings

5. To edit which functions this Operator ID can access, touch Edit. The Authorized Operator- Operator access screen 1 of 2 displays.

6. To allow this operator to run patient tests, touch Enabled. To prevent patient tests, touch Disabled.

7. To allow this operator to run 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. The Authorized Operator- Operators list screen displays.

12. Touch Exit.

13. Touch Done 3 times to return to the Select Ready screen.

Viewing, Editing, Printing, and Deleting Operator IDs

You can view, print, or delete the entire operator list or edit individual operators.

NOTE: If you delete the entire operator list, ensure that authorized operators is Disabled. See Setting Operator IDs above.

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Instrument Set Up

Instrument Settings

At the Authorized operator screen, perform the following steps:

1. To delete the entire operators list, touch Delete operators list. The Delete operators list caution screen displays.

2. To delete, touch Yes. 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. The Authorized Operator- 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: Enabling the instrument

password restricts access to Instrument Setup to those who know the password. If both Operator ID and password are enabled, the Operator ID has priority.

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.

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Instrument Set Up

Instrument Settings

Printer Settings

This section describes how to customize the printed test results.

Customizing the Printout

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. The Choose Settings screen displays.

2. Use the arrow keys to select Instrument Settings.

3. Touch Select. The Instrument Settings screen displays.

4. Use the arrow keys to select Printer Settings.

5. Touch Select. The Printer Settings-Included in print-out screen 1 of 4 displays.

6. To select options, for example Operator Name, Serial Number, Patient Name, or Patient ID to include in the printout, touch the option button.

5-30

Instrument Set Up

7. Touch Next.

8. To select options, for example,

9. Select Next.

10. To include a custom header in

11. To edit or create line 1 of a

12. Enter custom header text.

13. Touch Enter.

14. To edit or create line 2 of a

Instrument Settings

To remove a selected option, touch that option button again.

The Printer Settings-Included in print-out screen 2 of 4 displays.

Color, Clarity, or Custom Information to include in the printout, touch the option button. To remove a selected option, touch that option button again.

The Printer Settings-Set Up Custom Header screen 3 of 4 displays.

the printout, touch Enabled. To exclude a custom header, touch Disabled.

custom header, touch Enter Line 1. The Custom Header screen displays.

Use the alphabetic keyboard to enter text. To enter numeric text, touch 123.

The Printer Settings-Set Up Custom Header screen 3 of 4 displays.

custom header, touch Enter

Line 2.

NOTE: Each custom header line

accepts up to 24 alphanumeric characters.

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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.

18. Touch Done 3 times to return 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

Clinitek Status Connect System Operator’s Guide.

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Instrument Set Up

Restore Default Settings

This option lists the analyzer’s original settings.

Use the up and down arrows to 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.

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Instrument Set Up

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 Providers and Distributors).

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Instrument Set Up

Sample Notes

Sample Interference Notes

To include Sample Interference Notes, 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 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.

5. Touch Done twice to return to the Select screen.

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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.

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Instrument Set Up

System Information

This completes the settings and choices within Instrument Set Up. Touch Done to return to the main Select screen.

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Recall 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.

The next screen displayed is 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.

The results will automatically be sent to the connected computer if this option is set up in the analyzer.

If you require further instruction regarding how to set up the analyzer so the results are automatically sent to a computer see Section 5, Instrument Set Up.

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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.

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Recall Results

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

Clinitek Status Connect System Operator's Guide.

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Troubleshooting

General Information

Your Clinitek Status®+ analyzer will operate properly if you follow the directions for using and cleaning the instrument.

Error Messages

Error messages will be displayed to help you when the Clinitek Status+ analyzer detects something which needs your attention. The format of this advisory information depends upon the importance of the problem and the mode in which the instrument is being used.

To correct an error, see the List of Errors and Advisory Messages located at the end of this section.

Errors which Disable the Instrument

If the error is one which prevents the instrument from being used, all 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.

Advisory Messages

Errors of less importance will be presented via a message on the main Select screen when this screen is next displayed. When you have taken corrective action, the message will be removed from the display. If more than one of this class of error occurs, clearing one message will enable the next to be displayed in order of importance to a user.

Results Alert

If an error occurs during testing and the test cannot continue because of the error, this will be presented via the Results Alert screen. This will provide details of the error and show that the test has been cancelled. The test table will be extended so that the urinalysis strip or Clinitest® cassette can be removed.

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.

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Troubleshooting

Battery Power Icon

The battery icon indicates the power level of the battery. Power can be reduced while testing continues, with an advisory message displayed on the main Select screen. If battery level falls too low to power the analyzer, all selection areas on the display will be disabled until the batteries are replaced (if you require detailed instructions regarding how to change the batteries see Section 9, Cleaning and Maintenance).

Paper-out Icon

A paper-out icon appears in the top of the title bar when the printer paper/label roll needs replacing. An advisory message will be displayed on the main Select screen. Replace with new paper or label roll as instructed in Section 1, Loading the Printer Paper or Label Roll.

Dashes may appear next to Color and Clarity on test result printouts. This occurs when the instrument is powered by batteries. Color and Clarity are selected in the Instrument Set Up, but no selections have been recorded on the Select Appearance screens before time-out.

The time-out on these screens is designed to ensure that battery life is preserved. The Color and Clarity description may be added to the printout in writing if needed.

Irregular or Slow Movement of Test Table

If movement of the test table is irregular or slow, this may be caused by:

a) heavy buildup of dried urine on the test table. Clean the test table and insert as described in Section 9, Periodic Cleaning of Test Table.

b) low battery power. Replace the batteries as described in Section 9, 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.

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Siemens Clinitek User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

A Brief Description

Understanding the Symbols and Display Icons

Unpacking & Set Up

Interacting with the Touch Screen

Start-Up Wizard

Testing

Instrument Set Up

Recall Results

Troubleshooting