Table of Contents

Section 1 Introduction .............................................................................................................1

Intended Use ...........................................................................................................1

Section 2

Analyzer Components .............................................................................................2

Analyzer Component Illustrations .............................................................................2

Section 3 Initial Startup ............................................................................................................3

Section 4 Analyzer Setup.........................................................................................................4
Test Settings ....................................................................................................... 4
Type of Strip .............................................................................................................4
Mode .......................................................................................................................5
Test Number ............................................................................................................5
Continuous Test .......................................................................................................6
Operator ID ..............................................................................................................6
Units ........................................................................................................................6

Analyzer Configuration ...................................................................................... 6

Printer Setup ............................................................................................................6
Sound ......................................................................................................................7
Barcode reader ........................................................................................................8
Language .................................................................................................................8
Date/Time ................................................................................................................8
Auto Number Reset ..................................................................................................9

Database ............................................................................................................. 9
Clear all Records.................................................................................................... 10
Locate Record........................................................................................................ 10
View Current Record .............................................................................................. 10

Self Test ............................................................................................................. 11

QC Test .............................................................................................................. 11
QC Setup ............................................................................................................... 11
Run QC Test .......................................................................................................... 12

User Login .........................................................................................................13

ID Admin ................................................................................................................ 13

Section 5

Analyzer Operation ................................................................................................ 16

Entering Canister Code ....................................................................................18
Normal Operation, no Barcode reader .............................................................19
Sample/Strip Preparation........................................................................................ 19
Strip Test Single Test Mode ................................................................................. 19
Strip Test Continuous Test Mode.......................................................................... 21

Normal Operation, Barcode reader installed ...................................................22

Strip Test Single Test Mode with Barcode reader ................................................. 22
Strip Test Continuous Test Mode with Barcode reader.......................................... 23

Urine Controls QC Testing................................................................................25

Strip Preparation .................................................................................................... 25
Urine Control Test Procedures ................................................................................ 25

QC lockout .........................................................................................................26
Section 6 Data/Communication ............................................................................................. 28
External Printer ...................................................................................................... 28
Barcode reader ...................................................................................................... 28

Section 7 Quality Control....................................................................................................... 29

Section 8 Maintenance........................................................................................................... 30
Loading Printer Paper .......................................................................................30
General Cleaning...............................................................................................31
Daily Cleaning ...................................................................................................31
Remove the Strip Holder ........................................................................................ 31
Clean the Strip Holder ............................................................................................ 31
Load the Strip Holder ............................................................................................. 31
Return the Strip Holder/Mount to its Internal Position .............................................. 32

Sample Deposit Cleaning .................................................................................32

Strip Holder Sterilization...................................................................................32
Section 9 Precautions ............................................................................................................ 33
Section 10 Troubleshooting .................................................................................................. 34
Appendix 1 Urine Analyzer Specifications ........................................................................... 35
Appendix 2 Compatible Urinalysis Reagent Strips .............................................................. 36
Appendix 3 Clarity Urinalysis Reagent Strips Parameter Table .......................................... 42
Appendix 4 Result Print-Out.................................................................................................. 43
Appendix 5 Barcode reader ................................................................................................... 44
Appendix 6 Catalog ................................................................................................................ 45
Appendix 7 Index of Symbols................................................................................................ 46
Appendix 8 Warranty ............................................................................................................. 47

Section 1 Introduction
The Clarity Urocheck 120 Urine Analyzer reads urine test strips.
and prints reports without the need for special training.

It stores results

The Clarity Urocheck 120 Urine Analyzer runs a self-test each time the power
switch is turned on. An optional barcode reader records patient ID. The barcode
reader verifies strip canister barcodes. Use only Clarity Urinalysis Reagent Strips
with the canister barcode for correct results.
The Clarity Urocheck 120 Urine Analyzer is CLIA waived when used with strips of
the same brand as the analyzer. Only laboratories with a Certificate of CLIA
Waver may use this analyzer in a waived setting. Users should read this
complete test procedure before performing a test using this analyzer. Failure to
adhere to these instructions for use and for performing QC testing is considered
off-label use. Off-label use is categorized as high complexity and subject to all
CLIA regulations.

Intended Use
The Clarity Urocheck 120 Urine Analyzer is intended for use in conjunction with
the Clarity Urinalysis Reagent Strips for the semi-quantitative detection of the
following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific
Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes as well as the qualitative
detection of Nitrite. The instrument is intended for professional, in vitro diagnostic
use only.
Note:

Keys on the Keypad are listed in bold. Display items on the

screen are listed in bold italics in the manual.

Section 2

Analyzer Components

Analyzer Component Illustrations

1. Keypad
2. Liquid Crystal Display
3. Printer Cover
4. Paper Release Lever
5. Printer Paper
6. Printer Cover Pull
7. Printer Paper Access Slot
8. Strip Holder
9. Strip Holder Channel

10. Strip Holder Stop

11. White Calibration Circle
12. Strip Holder Mount
13. USB Port
14. External Printer Port
15. Standard RS232C Port
16. Power Socket
17. Fuses
18. Power Switch

Section 3 Initial Startup

Place the analyzer on a level surface.
access.

Allow 20cm on all sides of the analyzer for

Plug the power cord into a power outlet. Press the power switch (18) located on
the back panel to turn the Clarity Urocheck 120 Urine Analyzer on. The Clarity
Urocheck 120 Urine Analyzer will run a Self-Test. Optical Sensor Failed will
display due to lack of Strip Holder. The Strip Holder Mount will extend for Strip
Holder installation. Turn off the Power Switch.
Remove the Strip Holder from its plastic packaging. Place the Strip Holder on the
Strip Holder Mount. Position the white Calibration Circle up and towards the back
of the analyzer. It will slide loosely in the locating channel. Push the Strip Holder
in until it clicks into place. It will be held firmly on the Strip Holder Mount. Ensure
the Strip Holder is installed properly. If it is not locked onto the Strip Holder Mount
the analyzer will display Optical Sensor Failed.

Turn the Power Switch on.

shown.

If the Self-Test passes, the Initial Screen will be

If the Self-Test fails, a Failed Screen will be displayed. The analyzer cannot be
operated. Press the power switch off then on to re-test. Refer to Section 10
Troubleshooting to correct a failure.
Press MENU to access the Test Settings, Analyzer Configuration, Database
functions, Self-Test and QC Test.
Note:

Use the arrow keys on the keypad to select Exit or press the
Cancel key when Exit is not available.

Press START to begin strip testing.

Press ENTER for ID Admin.

3

Section 4

Analyzer Setup

Press Menu from the Initial Screen to display the screen below.

Select options by pressing or until the Selection Arrow () is next to the

option. Press ENTER to show the options in a new screen or cycle through the
settings below. Select Exit and press ENTER to return to the Initial Screen.

Test Settings
Select Test Settings to display the menu shown below.

Press or to select an option. Press Enter to show or change the option

settings below. Select Exit and press Enter to return to the Main Menu.
DTG-4OB, DTG-5OB, DTG-URO7 and DTG-10SG are examples of Type of Strips.
Refer to Appendix 2 for actual Analyzer-Read Type of Strips.
Type of Strip
Mode
Test Number
Continuous Test
Operator ID

Units

DTG-4OB, DTG-5OB, DTG-URO7, DTG-10SG

Routine, STAT, QC
User selected number
On, Off (single test)
If User Login is off, Operator ID will be 01 through 10.
If User login is enabled, Operator ID will be 11
through 20, and 100 for the Administrator
Conventional Units or Standard International (SI)

Type of Strip
Select Type of Strip and press ENTER to change the strip type. Each strip type
name defines the number of test parameters. If User Login is enabled and
Operator ID is 11 through 20, this setting cannot be changed.
Refer to Appendix 2 for a detailed list of available parameters.
Note:

Ensure the type of strip selected corresponds with the strip to be

used. If it does not, an error message will be displayed.
4

Mode
There are three test mode options.
change the Mode.
Note:

Press ENTER when Mode is selected to

The Mode can be changed during normal testing for STAT tests.

Routine Test
Use for normal urine testing. The default test number ranges from 1 to 99999.
resets to 1 every day automatically if Auto Number Reset is set to Yes.

It

STAT Test
Use for emergency urine testing. The default test number is from 100001 to
199999. It resets to 100001 each day automatically if Auto Number Reset is set
to Yes. The analyzer will automatically switch to STAT test and can not be
changed if the QC test has failed.
QC Test
Use to test positive/negative controls. If QC lockout is on, this test will be run
automatically. The test number ranges from 200001 to 299999. It resets to
200001 every day automatically if Auto Number Reset is Yes.
Note:

Ensure QC Test mode is used for testing positive and negative

controls. Use of any other mode will report the testing results as a
regular specimen and will not display proper Pass/Fail QC test
results.

Test Number
Select Test Number and press ENTER.

Enter the new Test Number. Press ENTER to confirm.

delete any changes and keep the existing number.

Press CANCEL to

The first digit in the number will depend on the Test Mode. The first digit will be 0
for Routine, 1 for STAT and 2 for QC Test. This first digit is fixed and cannot be
changed from this screen. Tests run after this number is changed will be set
sequentially from the new number.
Note:

Specimens may be assigned the same test number. They will be

distinguished by test date and time in the Database.

Continuous Test
Select Continuous Test and press ENTER to cycle the settings to Off or On.
When the selection is correct, select EXIT and press ENTER to return to the Main
Menu.
Continuous Test Off (Single Test Mode)
Test one strip at a time.

Single Test Mode performs 60 tests / hour.

Continuous Test - On
Test strips one after another. Continuous Test Mode performs up to 120 tests
per hour. When Continuous Test is on, the
symbol will be displayed.

Operator ID
Select Operator ID and press ENTER to increase the number by one. After 10, it
reverts back to 01. If User Login is enabled and Operator ID is 11 through 20,
this setting cannot be changed. Select EXIT and press ENTER to return to the
Main Menu.

Units
Select Units and press ENTER to cycle the units between Conventional or SI
units. If User Login is enabled and Operator ID is 11 through 20, this setting
cannot be changed. Select EXIT and press ENTER to return to the Main Menu.
Note:

Arbitrary results will always be printed.

Analyzer Configuration
Select Analyzer Configuration from the Main Menu to display the screen below.

Press or to move to make changes. After all changes are made, select
EXIT and press ENTER to save changes and return to the Main Menu. If User
Login is enabled and Operator ID is 11 through 20, this Menu cannot be changed.

Printer Setup
Select Printer Setup to display the screen below.

Press or to move to select the options listed below.

change the option as shown below.

Press ENTER to

Select Printer
Internal or External
Print Darkness
1 through 9
Printer Mode
Normal or Expand fonts
Auto-print
On or Off
Print Copies
1 to 3
Select Exit and press ENTER to save changes. The screen will then return to the
previous Menu.
Select Printer
Internal prints the results on the internal printer.
External prints the results on an external printer. The symbol
will display
on all screens. Contact Clarity Diagnostics Technical Support for a list of printers
and printer cables that can be used.
Print Darkness
Print darkness ranges from 1 to 9.
The default is 6.

The darkest is 9.

After 9 it reverts back to 1.

Printer Mode
Normal prints the standard font size and saves paper.
font size and uses more paper.

Expand prints a larger

Auto-print
Auto-print On prints the results after each test.
requires pressing the Print key to print the results.

is displayed. Auto-print Off

is not displayed.

Print Copies
Print Copies defines the number of result copies printed at one time.
Copies can be set from 1 to 3.

Print

Sound
Select Sound and press ENTER to cycle the options to Off, On and Prompts.
These options function as listed below.
Off internal speaker is Off in all cases
7

On Internal speaker is On in all cases (keyboard and prompts)

Prompts Internal speaker is On only for prompts to the operator.
Select Exit with and press ENTER to save changes.
the Main Menu.

The screen will return to

Barcode reader
Select Barcode reader and press ENTER to display Yes to allow Barcode reading.
Press ENTER to cycle between Yes or No. Yes displays prompt for full usage of
the Barcode reader. The Barcode reader icon
will be shown. If the optional
Barcode reader is not present, this setting should be set to No.
Select Exit with and press ENTER to save changes.
the Main Menu.

The screen will return to

Language
Select Language and press ENTER to change the current language.
ENTER is pressed the language changes.
Select Exit with and press ENTER to save changes.
the Main Menu.

Each time

The screen will return to

Date/Time
Select Date/Time and press ENTER to display the screen to change the date/time
as shown below.
Select Exit and press ENTER to save changes.
previous Menu.

Press or to move to the options listed below.

selected option.

The screen will return to the

Press ENTER to change the

Date Format
Select Date Format and press ENTER to cycle to MM-DD-YY, YY-MM-DD or
DD-MM-YY.
Time Format
Select Time Format and press ENTER to cycle to 24 Hour or 12 Hour.
displays the time with am/pm symbols.
8

12 Hour

Set Date and Time

Select Set Date and Time and press ENTER to display a new screen for setting
the current date and time.

The first digit to be changed in the date will be highlighted. Press or to

change the number one at a time. Continue to press or until the correct
number is shown. Press or to progress to the next digit to be changed.
Press or to increase or decrease the number. Change each of the time and
date digits/fields in this manner. Press ENTER to save the changes and exit the
screen. Press CANCEL to not accept any changes and exit the screen. Either
key will return to the previous screen.

Auto Number Reset

Select Auto Number Reset and press Enter to cycle to Yes or No. If Yes, the
test number will reset to 000001, 100001 or 200001 for Routine, STAT or QC
modes each day. If No the test number is unaffected by date.

Database
Select Database and press ENTER to display the screen below.

Press or to move to enter each screen and make changes. After all
changes are made press ENTER to save changes and return to the Main Menu.
Up to 2000 records can be stored in memory. If User Login is enabled and
Operator ID is 11 through 20, the operator can only review data stored in the
analyzer.
Caution:

Use a number higher than the previous test number.

If there are 2000 records stored in memory, the oldest record will be erased and
replaced.
Records may have the same number but different dates and times.
9

Clear all Records

Select Clear all Records and press ENTER. If User Login is enabled and
Operator ID is 11 through 20, the analyzer will not respond.

Press ENTER to delete all records. A prompt will appear. Once records are
deleted they cannot be recovered. The Test Number will reset to 000001,
100001 or 200001 depending on the Test Mode. Press any other key to cancel.
The screen will return to the Database Menu.

Locate Record
Select Locate Record and press ENTER.

Press the number keys to enter the Test Number and/or test Date.
to view the results.

Press Enter

If only the Test Number is entered records with the current Date will be searched.
If there is no Test Number with the current Date, the latest previous Date will be
searched. For example, assume the current date is 2007-03-27. There are two
records with the same Test Number but dates of 2007-03-26 and 2007-03-20.
The test from 2007-03-26 will be displayed.
If there is no record found Record not found will be displayed.
return to the Database Menu.

Press any key to

Press Print to print a record.

Press to view the previous record.

Press to view the next record.

Press CANCEL to return to the previous screen.

located, reviewed or printed.

Additional records can be

View Current Record

Select Current Record and press ENTER to show the data from the current or last
record.
10

Press Print to print a record once it is displayed.

Press to view the previous record.

Press to view the next record.

Press CANCEL to return to the previous screen.

Self Test
Select Self Test and press ENTER to perform self tests.
display the results of each test.

A results screen will

After each test, a pass or fail is displayed on the screen. If any results fail, the
unit will not operate. Refer to Section 10 Troubleshooting.
Press CANCEL to return to the Main Menu.

QC Test
Select QC Test and press ENTER. If User Login is enabled and Operator ID is
11 through 20, the operator can only view settings and run a QC test.

Press or to move to make changes.

save changes.

QC Setup
Select QC Setup and press Enter.

11

Select Exit and press ENTER to

QC Lockout
Select QC Lockout and press ENTER to cycle the options Off or On.
Off disables the QC lockout function.
displayed.

The QC symbol and Setup Options are not

On enables the QC lockout function. The QC symbol is displayed.

timing can be set for Every 8 Hours, Daily, Weekly or Monthly.

QC Lockout

Time
Select Time and press ENTER to set the QC test for Every 8 Hours, Daily,
Weekly or Monthly.
Time Setup
Select Time Setup and press ENTER.

Every 8 Hours / Daily

Weekly / Monthly

The first highlighted digit will be changed. Press or to change. Continue to

press or until the correct number is shown. Press or to progress to the
next digit to be changed. Press or to increase or decrease the number.
Change each of the time and date digits/fields in this manner until the desired date
is shown. Press ENTER to save the changes and exit the screen. Press
CANCEL to not accept changes and exit.
There is no Date Setup if QC tests are set for Every 8 Hours or Daily.
For the Monthly option, Date can be set from 01 to 28.

29, 30 and 31 are invalid.

Run QC Test
Select Run QC Test and press ENTER to perform a QC test before the next
scheduled test time.

12

User Login
Press ENTER from the Initial Screen to show the Administrator login screen.
Operator ID is preset to 100.

On entry to this
time, leave the Passcode blank and press ENTER.

The

screen for the first

Press CANCEL to return to the Initial Screen without enabling User Login.

ID Admin
The Administrator screen is shown.

Press or to move the to make changes. If Passcode is blank, user login

is not yet enabled and only Change Admin Passcode can be chosen. Select
Exit and press ENTER to save changes.
Change Admin Passcode
Change the passcode from blank to a valid passcode, select Change Admin
Passcode and press ENTER.

A non-blank passcode must be entered to enable User Login. If a blank is

entered, a new screen will indicate the passcode is invalid. After 3 seconds, the
screen will return to the login screen.

13

Press CANCEL to keep the existing passcode and exit.

Scan or enter a valid Passcode and press ENTER to accept and exit.
Login will be enabled.

User

Operator Setup
After User Login is enabled, select Operator Setup and press ENTER.

X indicates the ID is enabled. O indicates the ID is not enabled

Press or to move the cursor to the desired ID.
Passcode screen.

Press ENTER for the

Scan or enter a new Passcode. Press ENTER to save the settings and exit.
Press CANCEL to cancel the settings and exit. Enter a blank Passcode to
disable the ID.
Logout
After the User Login is enabled, select Logout and press ENTER to log out. The
normal Login screen will be shown for a new operator login. See Section 5 for
Login procedures.

14

Press CLEAR from the Initial Screen to logout and display the Login Screen shown
above.

15

Section 5

Analyzer Operation

If User Login is not enabled, the Initial Screen will be shown after Self Test.
Refer to Section 3 Initial Startup.
If User login is enabled, the analyzer will display a login screen after Self Test.

Enter the ID and enter or scan the Passcode.

Press CLEAR to return to the login screen.

Press ENTER to run the analyzer.

If the Passcode is incorrect, the analyzer will indicate a passcode error.

seconds, the screen will return to the login screen.

After 3

If the Passcode is correct, the analyzer will display the Initial Screen.
logged-in ID will be shown (11-20, or 100).

The

The user ID will be 11-20 for Operators. This provides access to operate the
analyzer, change test modes and test number, and review settings. Press
CLEAR from the Initial Screen to logout and display the Login Screen.
The user ID will be 100 for the Administrator. This provides full access to operate
the analyzer and change settings. Press ENTER from the Initial Screen to display
the ID Admin Screen. Press CLEAR from the Initial Screen to logout and display
the Login Screen.
Press START on the Initial Screen to test strips.
before testing.
16

Check all settings and strip types

During testing, the screens will display icons showing the status, options available
and prompts for testing:
No.
000001

The sequential test number assigned to the next test to be run. In

Routine Mode, the first digit will be 0. In STAT Mode, the first digit
will be 1. In QC Mode, the first digit will be 2.

DTG-10SG

Indicates the proper strip to be tested has 10 test pads. Standard

strips available are 4, 5, 7, or 10 test parameters, refer to Appendix 2.
Select the strip configuration using the MENU function from the Initial
Screen. The strip type must match the strip being used or result will
not be displayed.

Mode

Indicates the current mode setting. Available modes are Routine,

STAT and QC. Press ENTER from this screen to change the mode.
Continue to press ENTER to cycle through each mode. The mode
may be changed when this prompt appears.
When visible, Continuous Test is set to test up to 120 tests per hour.
If not, Single Test is set to test one strip at a time up to 60 tests per
hour.
When visible, the printer is set to Auto-print. Test data is sent to the
internal printer and data ports after each test. Results are displayed
on the screen. If this icon is not visible, press Print to send results
to the printer and data port.
When visible, Auto-Print is On. Test data is sent to the external
printer and data ports after each test.
When visible, indicates the Barcode reader is enabled.
If only EXT is visible, Auto-Print is Off.
data to the printer and data port.
Strip Lockout is On.
barcodes.

QC

Press Print to send test

The analyzer will only test strips with correct

When visible, indicates QC Lockout is On. When the scheduled test

time arrives, this symbol will flash. A beep will be heard to prompt
that a QC test is required before performing additional tests.

17

Entering Canister Code

When a new canister of strips is required, the analyzer will request that a canister
code is entered from the new canister. The code can be entered manually from
the keypad, or scanned with the Barcode reader, if installed.
At first startup, the Strip Holder will fully extend.
displayed.

The screen below will be

Scan or manually enter the canister code from the strip canister.

Press CLEAR to move the cursor to the proper digit if you entered an incorrect
number. Edit the number as needed. After the last digit of the correct code is
entered, the next screen will be shown. Press CANCEL to cancel the changes and
exit the screen.
If the canister
following screen

code is incorrect, the

will show.

18

Press CANCEL to exit to the previous screen.

If the canister code is correct, the analyzer will proceed to the Initial Screen.

Note:

Refer to Section 4, Analyzer Setup, to change the settings.

When there are only 5 strips remaining,

will flash to prompt that a new canister
of strips is required. The number of strips left can be seen under .
When the current run is completed, enter the new canister code.
under
will be increased accordingly.

The number

Normal Operation, no Barcode reader

Sample/Strip Preparation
Allow the strip, urine specimen, and/or controls to reach room temperature at
15-30C (59-86F) prior to testing.
Note:

Only Clarity Urinalysis Reagent Strips work with the Clarity

Urocheck 120 Urine Analyzer. Use of any other strips will cause
inaccurate results.

Remove the strips from the closed canister. Use them as soon as possible.
Tightly close the canister after removing the strips.

Strip Test Single Test Mode

Press ENTER for the strip prompt. Wait for the audible triple beep to immerse the
strip.

Once START is pressed, the screen below will show.

19

The countdown clock is displayed on the bottom right. The clock will start to count
down from 65. The operator has 3 seconds before the triple beep sounds to
immerse the strip into the urine.
Upon hearing the triple beep and/or seeing the countdown clock reach 62,
completely immerse the reagent areas of the strip in fresh, well-mixed urine.
Immediately remove the strip to avoid dissolving the reagents.

Run the edge of the strip against the rim of the urine specimen container to remove
excess urine. Hold the strip in a horizontal position. Bring the edge of the strip
into contact with an absorbent material (e.g. a paper towel). This prevents mixing
chemicals from adjacent reagent areas.

Place the strip with the reagent area facing up, onto the Strip Holder Channel.
Make sure the strip end touches the Strip Holder Backstop as shown below.

Note:

When the countdown clock on the display reaches 1, the Strip

Holder will carry the strip inside and begin testing.
An automatic calibration is done before each test.
The results will be displayed on the screen and stored in memory
after each test. Any abnormal results will be highlighted on the
screen and flagged on the print out.
If Auto-print is set to on the results will be printed.
is set to off, press Print to print the results.
20

If Auto-print

Remove the used strip from the Strip Holder when the strip carrier moves out.
Discard the used strip according to local regulations.
Repeat the previous steps to test more urine.

Strip Test Continuous Test Mode

Press START when the Strip Holder is fully extended to begin the test. The
following screen will be displayed. Wait for the audible triple beep to immerse the
strip.

Note:

Timing is set up to process a new strip every 30 seconds.

Once START is pressed, the screen will change to the following:

The countdown clock is displayed on the bottom right of the screen. The clock will
start to count down from 65. The operator has 3 seconds before the triple beep
sounds to immerse the strip into the urine.
Upon hearing the triple beep and/or seeing the countdown clock reach 62,
completely immerse the reagent areas of the strip in fresh, well-mixed urine.
Immediately remove the strip to avoid dissolving the reagents. Handle and test
the strips as described in Strip Tests - Single Test Mode above.
Place the first strip onto the Strip Holder Channel. Ensure the reagent pads face
up. Make sure the end of the strip touches the Strip Holder Backstop.
Listen for the next triple beep and/or see the countdown clock reach 32. Immerse
a new second strip in fresh, well-mixed urine. Repeat the strip testing steps
above. Lay the second urine-exposed strip on a paper towel, with reagent pads
up. Wait for the first strip to complete testing and the Strip Holder to move out.
Listen for the next triple beep and/or see the countdown clock reach 2. Immerse
a new third strip in fresh, well-mixed urine. Repeat the strip testing steps above.
Lay the third strip on a paper towel with reagent pads up. Wait for the Strip Holder
to move out.
Note:

When the countdown clock reaches 1, the Strip Holder will carry
21

the first strip inside. The countdown clock also returns to 30.
The results will be displayed on the screen for several seconds and
stored in memory. If Auto-print is on, the results will be printed.
Remove the completed first strip after the Strip Holder moves out. Immediately
place the second strip on the Strip Holder before the countdown clock reaches 1.
The Strip Holder will carry the new strip inside for analysis.
Note:

The operator has about 8 seconds to discard the used strip and
place the next strip on the Strip Holder.

After the first time the countdown clock reaches 1, it will return to 30 instead of 65.
A triple beep occurs every 30 seconds. This prompts the operator to immerse a
new strip.
Discard the used strip according to local regulations.
Repeat the above process for additional urine specimens.
Press Cancel to stop testing when all tests are done.

Normal Operation, Barcode reader installed

Plug the RS232C cable from the Barcode reader into the Standard RS232C Port
in the back of the analyzer. Use the cable supplied with the Barcode reader.
Refer to Appendix 5 Barcode reader for specifications and compatibilities.
If both the optional Barcode reader and external data transmission capability are
used at the same time, use the serial splitter cable to connect both external
computer and Barcode reader to the analyzer Standard RS232C port.
Ensure the analyzer parameters are configured properly as described in Section 4
Analyzer Setup, with Barcode Reader set to Yes. Turn the power switch
located at the back panel of the analyzer on.

Strip Test Single Test Mode with Barcode reader

Press START from the Initial Screen.
A prompt to scan the Barcode ID with the reader will display. If a Barcode reader
is installed, hold the Barcode reader over the barcode on the specimen container,
and press the Scan button on the Barcode reader. A red illuminated line will
appear over the barcode to be read. Move the Barcode reader to align the red
line over the barcode. Position it until the Barcode reader beeps, indicating the
barcode has been scanned. When the reading has been completed, it will appear
next to ID. ID will reflect the last barcode read by the reader. It will change every
time a new barcode is read until START is pressed to begin the test.
If a Barcode reader is not installed, enter the ID manually using the keypad.
Press CANCEL to clear the input, START to begin the test.
Press MENU to change the current testing mode.
After the barcode is entered, ID will display.
strip.
22

Review the ID before testing the

Press START after the ID has been entered to display the next screen.

Press START again to begin strip testing. The strip is tested the same as other
single test modes. The results screen will show the sample ID in the ID field.

If Auto-print is Off, press PRINT from the results screen to print results.
CANCEL to return to the previous barcode entry screen.

Press

Strip Test Continuous Test Mode with Barcode reader

If Barcode reader is On and
is displayed, samples are tested in batch mode.
Holding the Barcode reader over the barcode on the specimen container, press
the Scan button on the Barcode reader. A red illuminated line will appear over
the barcode to be read. Move the Barcode reader to align the red line over the
barcode. When the Barcode reader beeps the barcode has been scanned. All
sample barcode IDs in a batch are read and stored in memory in sequence.
Samples must be run in the same sequence as scanned. This ensures IDs and
samples correspond. Prompts are displayed to show the next sample to be
tested.
Press START to begin the batch mode.

23

Press CANCEL to return to the Initial screen.

Press ENTER to enter a new screen to edit the Barcode ID.

Using the keypad or barcode reader to enter the Barcode ID, press ENTER to
confirm the ID entered and enter the next number.
Press CLEAR to clear the entered ID.
CANCEL to exit to the previous screen.

Press PRINT to print the list of IDs.

Press START to save the IDs and return to the previous screen.

Up to 100 barcodes can be read.

have been read.
Note:

The screen will indicate how many barcodes

Do not change Barcode reader or Test number settings before all

barcodes have been processed. Otherwise remaining barcodes
may be deleted.

Press START to begin strip testing. The testing screen will be displayed as
shown below. This screen example shows a total of 10 strips to be run. It asks
for the first strip to be placed on the Strip Holder.

The next screen shows the barcode of the sample to be run and the next sample
ID to be run. This reduces the possibility of error and mismatch between the
barcode and the sample to be run.

24

When the test is complete, the Results Screen will show briefly.
can be placed on the Strip Holder.

Stop testing by pressing CANCEL when the prompt appears.

procedures are the same as testing with no barcode.

The next strip

All other testing

Urine Controls QC Testing

Ensure the operating Mode is set to QC. All test numbers in QC mode will begin
with 2. This allows results to be searched for and found easily.

Strip Preparation
Allow the strip and urine controls to reach room temperature at 15-30C (59-86F)
prior to testing.
Note:

Use Clarity Urinalysis Reagent Strips and Clarity Urine/HCG

controls for proper functioning and accurate results.

Remove strips from the closed canister and use them as soon as possible.
the canister tightly immediately after removing the strips.

Close

Urine Control Test Procedures

The urine control test procedures are the same as Normal Operation, no Barcode
reader, or Normal Operation, Barcode reader installed. Refer to Section 5
Analyzer Operation.
The results obtained during the Quality Control test will be referenced by the
analyzer with pre -programmed target values and report generated, If Auto-print is
set to On, the result will be printed.
If the QC test "Fails", please contact Clarity Diagnostics Technical/Customer
Support.

25

QC lockout
When QC lockout is turned On, the user will be notified when a QC test is required.
The following screen will be displayed. The QC symbol will flash.

Note:

Use Clarity Urinalysis Reagent Strips and Clarity Urine/HCG

controls for proper functioning and accurate results.

Press CANCEL to return to the Initial Screen. If canceled, the analyzer will
change the test mode to STAT. An E will be displayed after the test number on
all printouts to show QC tests were out of date and pending.
Press ENTER to run QC tests.

The analyzer will run a Level 1 QC test first.

details on testing.

Refer to the Strip Test section for

After testing, the analyzer will display the testing results.

If any parameter is out of range, it will be highlighted and marked with a *.

If Auto-print is set to On, the result will be printed.
Press ENTER to test control Level 2.

The steps are the same as for Level 1.

26

When Both QC Tests pass, the E at the end of the test number will not be shown.

27

Section 6 Data/Communication
The RS232 and USB ports can communicate with an external (optional) PC.
If Auto-print is On, the printed data on the internal printer is also sent to the
RS232 and USB ports. Connect either RS232 or USB cable to the back of the
analyzer to a PC with suitable software.
Please contact Clarity Diagnostics Technical Support for details on the data
transfer.

External Printer
The RS232 port can connect to an optional external printer for printing data.
Please contact Clarity Diagnostics Technical Support for details on external
printing.

Barcode reader
The RS232 port can also connect to an optional Barcode reader.
enter barcoded sample ID information.

It can read and

Please contact Clarity Diagnostics Technical Support for more details on the
Barcode reader.

28

Section 7 Quality Control

Each lab should use its own standard and procedures for performance. Test
known positive and negative specimens/controls at each of the following events in
accordance with local, state, and/or federal regulations or accreditation
requirements. For obtaining accurate results, it is advised to use Clarity
Urine/HCG liquid urine controls.

When a new canister of strips is opened

Test results seem inaccurate

A new operator uses the analyzer

Each new day of testing

or
or
or
or

After performing maintenance or service on the analyzer

If the QC tests do not provide expected results, perform the following checks:

Ensure the strips used are not past their expiration date.

Ensure strips are fresh from a new canister.

Ensure the controls are not past their expiration date.

Repeat the test to ensure no errors were made during the test.

If QC testing still does not provide expected results, call Clarity Diagnostics
Technical Support at 1-(877) 485-7877.

29

Section 8 Maintenance
Loading Printer Paper
Pull up on the finger pull area marked
to open the Printer Cover. Place paper
roll in the printer box. Feed the paper under the printer feed roller until the paper
sensor threads the paper through the printer. Pull the paper out, leaving 10 cm (4
inches) of extra paper above the Printer Roller. Thread the excess paper through the
Printer Paper Slot in the Printer Cover. Return the Printer Cover to its original
closed position.
Caution: The printer will only print on the outside surface of the roll.
placed incorrectly, there will be no printout.

If

If you are encountering difficulty when installing the printer paper or

if the paper roll is not feeding into the printer properly, bend the
leading edge of the paper roll upward toward the back of the
analyzer. Push the leading edge of the paper through the roller.
The paper roll will now easily feed through the Printer Roller.

30

General Cleaning
Keep the surface of the instrument free of dust at all times. If needed, the
external surfaces may be cleaned using a damp cloth. Do not use any type of
solvent, oil, grease, silicone spray, or lubrication on any part of the instrument.

Daily Cleaning
Remove the Strip Holder
Press Start to fully extend the Strip Holder/Mount.
Turn off the Power Switch after the Strip Holder/Mount is fully extended.
Remove the Strip Holder from its mount by pulling out gently by the two sides as
shown below.

Clean the Strip Holder

Clean the Strip Holder using a lint free/non-absorbent cotton swab/ball with distilled
water. Dry with a clean, dry cotton ball.
Examine the White Calibration Circle to ensure there are no nicks or dirt present.
Clean the White Calibration Circle as necessary using a cotton swab or cotton ball
with distilled water. Dry with a clean, dry cotton ball.
Note:

The White Calibration Circle should be replaced if any nicks or

non-removable dirt are found. To replace, please contact Clarity
Diagnostics Technical/Customer Support.

Load the Strip Holder

Grasp the Strip Holder by its sides as shown below. Place the Strip Holder on the
Strip Holder Mount with the white Calibration Circle facing up and positioned
towards the analyzer. It will slide loosely in the locating channel. Push the Strip
Holder in towards the analyzer until it snaps into place. It will be held firmly on the
Strip Holder Mount. Ensure the Strip Holder is installed properly. If it is not
locked onto the Strip Holder Mount, the Calibration Circle will not be in the correct
position. The analyzer will display Optical Sensor Failed.
Note:

When correctly positioned, the Strip Holder will snap into and be
locked in place, with the White Calibration Circle not visible. See
illustration below.

31

Return the Strip Holder/Mount to its Internal Position

Turn the Power Switch on and wait for the Strip Holder/Mount to move inside the
analyzer and stop. Turn the Power Switch off or begin testing strips.
Please refer to Section 5 Analyzer Operation.

Sample Deposit Cleaning

Remove the Strip Holder as above.
Clean the Strip Holder using a lint free/non-absorbent cotton swab or ball
dampened with 0.1 N NaOH.
Warning:

Do not allow the NaOH solution to touch the White Calibration

Circle.

Clean the excess NaOH from the Strip Holder using a cloth moistened with distilled
water.
Dry the Strip Holder with a clean lint free non-absorbent cotton swab or ball.
Replace the Strip Holder and return the Strip Holder/Mount it to its original position
as described above.

Strip Holder Sterilization

Remove the Strip Holder and repeat Daily Cleaning above.
Clean the Strip Holder using a lint free non-absorbent cotton swab or ball with one
of the following sterilizing solutions:
1. 2% Glutaraldehyde (sufficient density): Refer to detailed instructions
on the product label.
2. 0.05% Sodium Hypochlorite Solution: Add 1 mL 5% Sodium
Hypochlorite into 99 mL distilled water, or prepare a 1:100 dilution
ratio with appropriate final volume.
3. Isopropyl alcohol (70-80%).
Pour the sterilizing solution into a narrow vessel 10 cm (4 inches) high.
Dip the Strip Holder into the sterilizing solution
Caution:

Ensure the White Calibration Circle does not touch the solution.

Soak the Strip Holder in the sterilizing solution for 10 minutes.

Remove the Strip Holder, clean and dry it.
Load the Strip Holder and return the Strip Holder/Mount to its original position.

32

Section 9 Precautions
Follow the precautions listed below for accurate results and operation of the
analyzer.

The protection provided by the equipment may be impaired if used in a

manner not defined in this user guide.

Connect to a power connection which contains a working grounding plug.

Wear gloves to avoid contact with potentially hazardous biological

samples during processing strips, or analyzer components.

Avoid storing or operating the analyzer in direct sunlight, excessive

temperature or humidity. Refer to Appendix 1 Urine Analyzer
Specifications for operating condition requirements.

Never place anything within 7 cm of the front of the unit.

interference with the Strip Holder.

Keep the unit clean. Wipe it frequently with a soft, clean and dry cloth.
Use fresh water when needed.

Do not clean the unit with substances such as gasoline; paint thinner,
benzene compounds or other organic solvents. This will avoid any
damage to the Strip Holder, White Calibration Circle, or other
components.

Do not wash the LCD with water.

and dry rag.

The Strip Holder must be kept clean. Wipe the Strip Holder using fresh
water daily. Refer to Daily Cleaning in Section 8.

Follow all local regulations when discarding the unit or its accessories.

Do not use the unit or the strips outside of the operating temperature
ranges listed below.
Analyzer:
Strips:

0-40C (32-104F)

15-30C (59-86F)

33

This will avoid

Lightly wipe the LCD with a clean, soft

Section 10 Troubleshooting
Problem

Solutions

Strip Position Improper

Adjust the strip so the strip end is completely touching the Strip Holder
Backstop and centered in the Strip Holder Channel

Strip Missing

Insert strip

Strip Error

Ensure the type of strip used matches the type of strip setting
Ensure the strip brand is compatible with the analyzer
Ensure all of the test pads on the strip have been immersed in the
specimen

No display on screen

Fuse is damaged

Printer does not work

Main Control Unit Failed

Optical Sensor Failed

Test Accuracy Failed

Mechanism Failed

Excess Light Failed

Canister Code Error

QC Test Fail

Turn the Power Switch on

Make sure power is applied to the Analyzer
Examine the Fuse on the back of the analyzer to determine if it is
damaged and replace if necessary
Turn the Power Switch off, disconnect the plug and replace the damaged
Fuse with a new 2.0A Fuse
(Spare fuse is located in the fuse compartment)
Make sure Auto-Print is set to On. Refer to Printer Setup instructions
Load paper if necessary. Ensure Printer Setup is set for Internal when
an external printer is not connected
Ensure paper roll is placed correctly. If incorrect, there will be no
printout
Clean printer roller with ethanol
See that the proper side of the thermal paper is inserted in the printer
Remove paper jam by lifting up green paper release lever and removing
jammed paper. (See Section 2)
Turn the Power Switch off, then on. Perform a Self-Test. Refer to
Manual Self-Test section
Ensure the Strip Holder is locked onto the Strip Holder Mount correctly.
The Strip Holder should snap into place and locked onto the Strip Holder
Mount.
Ensure the white Calibration Circle is clean
Clean the Strip Holder and refer to Daily Cleaning section
Turn the Power Switch off, then on. Perform a Self-Test. Refer to
Manual Self-Test section
Turn the Power Switch off, then on.
Manual Self-Test section

Perform a Self-Test.

Refer to

Remove any obstacles in the path of the Strip Holder

Do not touch the Strip Holder when it is moving
Turn the Power Switch off, then on. Perform a Self-Test. Refer to
Manual Self-Test section
Ensure the analyzer is kept away from direct light
Ensure the white calibration circle is clean
Ensure the Strip Holder is positioned correctly on the Strip Holder Mount.
Refer to Daily Cleaning section
Turn the Power Switch off, then on. Perform a Self-Test. Refer to
Manual Self-Test section
Ensure the canister code entered is correct
Ensure the type of strip used is the same as the analyzer setting.
Ensure the control is correct
Ensure the type of strip is correct
Ensure the brand of strip is compatible with the analyzer
Ensure all of the reagent pads of the strip have been immersed

Please contact Clarity Diagnostics Technical Support for more information at 1-(877) 485-7877.

34

Appendix 1

Urine Analyzer Specifications

Feature
Methodology
Detection
Throughput
Memory
Strip Incubation Time
Detection Wavelengths

Analyzer Ports

Capabilities

Major Readable Barcodes

Available Languages on Screen
Analyzer Operating Conditions
Strip Operating Conditions
Power Source
Weight
Dimensions (L X W X H)
Display Dimensions (L X W)
This product complies with EN 61326.

Specifications
Reflectance Photometer
Photosensitive diode
Single Test Mode: 60 tests/hour
Continuous Test Mode: 120 tests/hour
Last 2000 results
1 minute
525 nm and 635 nm
Standard RS232C Port for Barcode Reader or Data
Transfer,
USB Port for Data Transfer,
25 Pin Parallel Port for External Printer
Internal Thermal Printer (included),
Optional External Printer (not included),
RS232C Barcode Reader (optional),
USB or RS232C Data Transfer Cable (optional)
See Appendix 5
English, Spanish and French
0-40C (32-104F); 85% Relative Humidity
(non-condensing)
15-30C (59-86F); 85% Relative Humidity
(non-condensing)
100-240V AC, 50/60Hz, 35 W
2.6 Kg (5.73 lbs)
27.2 cm X 26.9 cm X 14.6 cm (10.7 X 10.6 X 5.7)
10.8 cm x 5.7cm (4.2 X 2.2)

35

Appendix 2
No. of
Parameters
4
5

Compatible Urinalysis Reagent Strips

Type of Strip
DTG-4OB
DTG-5OB

DTG-URO7

10

DTG-10SG

Analytes
Blood, Leukocyte, Glucose, Protein
Leukocytes, Blood, Nitrite, Protein and Glucose
Leukocytes, Nitrite, Blood, pH, Protein, Ketone and
Glucose
Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood,
Specific Gravity, Ketone, Bilirubin and Glucose

Note:

Ensure that the type of strip selected corresponds with the strip to be used. If not, it will be
detected and display an error.
Only use Clarity Urinalysis Reagent Strips with the Clarity Urocheck 120 Urine Analyzer for
proper functioning and obtaining accurate results.

36

Performance Characteristics of Urinalysis Reagent Strips

The performance characteristics of the Clarity Urinalysis Reagent Strips have been determined in
both laboratory and clinical tests. The following table indicates performance characteristics for
each parameter.
Reagent

Leukocytes
(LEU)

Composition
derivatized pyrrole
amino acid ester;
diazonium salt; buffer;
non-reactive
ingredients
p-arsanilic acid;
N-(1-naphtyl)
ethylenediamine;
non-reactive
ingredients
p-diethylaminobenzald
ehyde; buffer and
non-reactive
ingredients
tetrabromophenol blue;
buffer and non-reactive
ingredients
methyl red sodium salt;
bromthymol blue;
non-reactive
ingredients

SensitivityVisual Reading

Sensitivity
Clarity Urocheck 120 Urine
Analyzer Reading

Detects leukocytes as low as Detects leukocytes as low as

9-15 white blood cells
12-15 white blood cells
(Leu/L) in clinical urine.
(Leu/L) in clinical urine.
Detects sodium nitrite as low
as 0.05-0.1 mg/dL in urine
with a low specific gravity and
less than 30 mg/dL ascorbic
acid.

Detects sodium nitrite as low

as 0.05 mg/dL in urine with a
low specific gravity and less
than 30 mg/dL ascorbic acid.

Detects urobilinogen as low

as 0.2-1.0 mg/dL (3.5-17
mol/L).

Detects urobilinogen as low

as 0.8-1.0 mg/dL (13.6-17
mol/L).

Detects albumin as low as

7.5-15 mg/dL (0.075-0.15
g/L).

Detects albumin as low as

12-15 mg/dL (0.12-0.15 g/L).

Permits the quantitative

differentiation of pH values
within the range of 5-9.

Permits the quantitative

differentiation of pH values
within the range of 5-9.

Blood
(BLO)

3,3,5,5-tetramethylben
zidine (TMB); cumene
hydroperoxide; buffer
and non-reactive
ingredients

Detects free hemoglobin as

low as 0.018-0.060 mg/dL or
5-10 Ery/L in urine
specimens with ascorbic acid
content of
<50 mg/dL.

Detects free hemoglobin as

low as 0.018-0.030 mg/dL or
5-10 Ery/L in urine
specimens with ascorbic acid
content of
<50 mg/dL.

Specific
Gravity
(SG)

bromthymol blue
indicator; buffer and
non-reactive
ingredients; poly
(methyl vinyl
ether/maleic
anhydride); sodium
hydroxide

Determines urine specific

gravity between 1.000 and
1.030. Results correlate
with values obtained by
refractive index method
within 0.005.

Determines urine specific

gravity between 1.000 and
1.030. Results correlate
with values obtained by
refractive index method
within 0.005.

Ketone
(KET)

sodium nitroprusside;
buffer

Detects acetoacetic acid as

low as 2.5-5 mg/dL (0.25-0.5
mmol/L).

Detects acetoacetic acid as

low as 4-5 mg/dL (0.4-0.5
mmol/L).

Detects bilirubin as low as

0.4-1.0 mg/dL
(6.8-17 mol/L).

Detects bilirubin as low as

0.8-1.0 mg/dL
(13.6-17 mol/L).

Detects glucose as low as

50-100 mg/dL (2.5-5
mmol/L).

Detects glucose as low as

80-100 mg/dL (4-5 mmol/L).

Nitrite
(NIT)

Urobilinogen
(URO)
Protein
(PRO)
pH

Bilirubin
(BIL)

Glucose
(GLU)

2, 4-dichloroaniline
diazonium salt; buffer
and non-reactive
ingredients
glucose oxidase;
peroxidase; potassium
iodide; buffer;
non-reactive
ingredients

37

Results of CLIA Waiver Study

A total of nine untrained non-laboratory users from three clinical sites in the US participated in the
study by testing a total of 560 urine samples using the Clarity Urocheck 120 Urine Analyzer over a
2 month period. The Clarity Urocheck 120 Urine Analyzer is intended for use in conjunction with
the Clarity Urinalysis Reagent Strips for detection of the following analytes in urine: Glucose,
Blood, Protein, Leukocyte, Nitrite, Bilirubin, Ketone, pH, Specific Gravity, and Urobilinogen. At
each study site, approximately 120 clinical urine specimens were tested by three untrained,
non-laboratory participants: phlebotomist, medical assistants, ultrasound technician. The results
(WM) were compared with the same specimens tested by professionally trained operators using
Bayers Clinitek 500 Urine Chemistry Analyzer (CM).
The CLIA waiver study demonstrated that the following performance data of the Clarity Urocheck
120 Urine Analyzer in the hands of non-technical users when using only the Quick Reference
Guide.
Bilirubin
Clarity
Urocheck
120
Urine
Analyzer

Bayer Clinitek 500 Urine Chemistry Analyzer

0

Total

410

419

15

23

12

21

42

74

76

Total

422

36

23

79

560

The exact agreement between the CM and the WM is 92.9% (520/560) with 95% CI: (90.4%;
94.8%). Agreement within +/- 1 block is 96.1% (538/560) with 95% CI: (94.1%; 97.5%).
Blood

Bayer Clinitek 500 Urine Chemistry Analyzer

0

10

25

80

200

Total

Clarity

191

16

208

Urocheck

10

11

37

52

120

25

14

39

61

80

35

42

200

13

184

197

Total

202

67

51

56

184

560

Urine

Analyzer

The exact agreement between the CM and the WM were 86.8% (486/560) with 95% CI: (83.7%;
89.5%). Agreement within +/- 1 block was 95% (532/560) with 95% CI: (92.9%; 96.7%).
Glucose

Bayer Clinitek 500 Urine Chemistry Analyzer

0

100

250

500

1000

Total

Clarity

389

393

Urocheck

100

32

41

120

250

14

45

64

500

18

1000

34

44

Total

396

50

60

45

560

Urine

Analyzer

38

The exact agreement between the CM and the WM is 86.3% (483/560) with 95% CI: (83.2%; 89%).
Agreement within +/- 1 block is 97.7% (547/560) with 95% CI: (96.1%; 98.8%).
Leukocyte

Bayer Clinitek 500 Urine Chemistry Analyzer

0

15

70

125

500

Total

Clarity

268

23

295

Urocheck

15

14

34

17

65

120

70

10

53

81

Urine

125

80

22

107

Analyzer

500

11

12

Total

291

67

78

88

36

560

The exact agreement between the CM and the WM is 79.6% (446/560) with 95% CI: (76.0%;
82.9%). Agreement within +/- 1 block is 90.5% (507/560) with 95% CI: (87.8%; 92.8%).
Protein

Bayer Clinitek 500 Urine Chemistry Analyzer

0

15

30

100

300

Total

Clarity

265

10

275

Urocheck

15

19

42

13

74

120

30

48

17

74

Urine

100

42

51

Analyzer

300

86

86

Total

284

61

61

59

95

560

The exact agreement between the CM and the WM is 86.3% (483/560) with 95% CI: (83.2%; 89%).
Agreement within +/- 1 block is 94.8% (531/560) with 95% CI: (92.7%; 96.5%).
Ketone

Bayer Clinitek 500 Urine Chemistry Analyzer

0

15

40

80

Total

Clarity

317

10

327

Urocheck 120

55

69

Urine

15

52

21

73

Analyzer

40

46

54

80

28

37

Total

322

65

67

76

30

560

The exact agreement between the CM and the WM is 88.9% (498/560) with 95% CI: (86.0%;
91.4%). Agreement within +/- 1 block is 97.3% (545/560) from each other with 95% CI: (95.6%;
98.5%).

39

Nitrite

Bayer Clinitek 500 Urine Chemistry Analyzer

0

>0

Total

Clarity Urocheck 120

387

390

Urine Analyzer

>0

25

145

170

Total

412

148

560

Positive percent agreement was 98.0% (145/148) with 95% CI: (94.2%; 99.6%).
percent agreement was 93.9% (387/412) with 95% CI: (91.2%; 96.0%).
pH

Clarity Urocheck 120

Urine Analyzer

Negative

Bayer Clinitek 500 Urine Chemistry Analyzer

5

5.5

6.5

7.5

8.5

Total

22

30

5.5

49

29

83

15

163

69

249

6.5

18

48

69

88

94

7.5

13

15

10

8.5

Total

86

198

94

139

17

10

560

The exact agreement between the CM and the WM is 62.5% (350/560) with 95% CI: (58.4%;
66.6%). Agreement within +/- 1 block is 98.4% (551/560) from each other with 95% CI: (97.0%;
99.3%).
Specific Gravity

Clarity Urocheck 120

Urine Analyzer

Bayer Clinitek 500 Urine Chemistry Analyzer

1.0

1.005

1.01

1.015

1.02

1.025

1.03

Total

1.0

20

20

1.005

73

75

1.01

32

37

80

1.015

30

69

43

142

1.02

91

24

121

1.025

61

17

78

1.03

43

44

Total

125

69

82

136

87

61

560

The exact agreement between the CM and the WM is 66.8% (374/560) with 95% CI: (62.7%; 70.7%).
Agreement within +/- 1 block is 99.3% (556/560) from each other with 95% CI: (98.2%; 99.8%).

40

Urobilinogen

Bayer Clinitek 500 Urine Chemistry Analyzer

0

Total

Clarity Urocheck 120

390

14

404

Urine Analyzer

41

49

22

18

40

26

19

45

22

22

Total

390

55

29

45

41

560

The exact agreement between the CM and the WM is 89.5% (501/560) with 95% CI: (86.6%;
91.9%). Agreement within +/- 1 block is 97.3% (545/560) from each other with 95% CI: (95.6%;
98.5%).

41

Appendix 3
Parameter Name
(Abbreviation on Display)
Leukocytes
(LEU)
Nitrite
(NIT)
Urobilinogen
(URO)

Protein
(PRO)

pH

Blood
(BLO)

Specific Gravity
(SG)

Ketone
(KET)

Bilirubin
(BIL)

Glucose
(GLU)

Clarity Urinalysis Reagent Strips

Parameter Table
Arbitrary

Conventional

1+
2+
3+
+

1+
2+
3+

1+
2+
3+
5.0
5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0

1+
2+
3+
1.000
1.005
1.010
1.015
1.020
1.025
1.030

1+
2+
3+
1+
2+
3+

1+
2+
3+

neg
15 Leu/L
70 Leu/L
125 Leu/L
500 Leu/L
neg
pos
0.2 mg/dL
1 mg/dL
2 mg/dL
4 mg/dL
8 mg/dL
neg
15 mg/dL
30 mg/dL
100 mg/dL
300 mg/dL
5.0
5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0
neg
10 Ery/L
25 Ery/L
80 Ery/L
200 Ery/L
1.000
1.005
1.010
1.015
1.020
1.025
1.030
neg
5 mg/dL
15 mg/dL
40 mg/dL
80 mg/dL
neg
1 mg/dL
2 mg/dL
4 mg/dL
neg
100 mg/dL
250 mg/dL
500 mg/dL
1000 mg/dL

42

Sl
neg
15 Leu/L
70 Leu/L
125 Leu/L
500 Leu/L
neg
pos
3.5 mol/L
17 mol/L
35 mol/L
70 mol/L
140 mol/L
neg
0.15 g/L
0.3 g/L
1.0 g/L
3.0 g/L
5.0
5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0
neg
10 Ery/L
25 Ery/L
80 Ery/L
200 Ery/L
1.000
1.005
1.010
1.015
1.020
1.025
1.030
neg
0.5 mmol/L
1.5 mmol/L
4.0 mmol/L
8.0 mmol/L
neg
17 mol/L
35 mol/L
70 mol/L
neg
5 mmol/L
15 mmol/L
30 mmol/L
60 mmol/L

Appendix 4

Result Print-Out

The printed results are shown below. Arbitrary units will always be printed.
Either Conventional or SI unit results will also be printed depending on the units
set.
Patient ID
Date/Time
Operator ID
Test Number
Abnormal Results

Test Parameters

ID: 0058164578
Date: 2008-04-19 16:54
Operator: 01
No. 000011
*GLU
1+
250 mg/dL
BIL
neg
KET

5 mg/dL
SG
1.030
BLO
neg
pH
5.5
PRO
neg
URO
0.2 mg/dL
NIT
neg
LEU
neg

Units

Depending on the type of strip selected, the analyzer recognizes the parameter
order and automatically ranks the display and printing sequence of each parameter.
Arbitrary results will always be printed automatically. Conventional or SI results
will be printed based on the units selected. Abnormal results, or results of
pathological significance will be marked with an *.
Arbitrary Results:

All positive results except pH and Specific Gravity (SG) will be reported as 1+,
2+, or 3+.

Positive results for pH and Specific Gravity (SG) will be reported with the
respective data.

Negative results for Leukocyte, Nitrite, Urobilinogen, Protein, Blood, Ketone,

Bilirubin, and Glucose will be reported as -.
Conventional or SI:

All positive results except Nitrite (NIT) will be reported with the respective data
in front of the units. The positive results of Nitrite will be reported as pos

All negative results except Urobilinogen (URO) will be reported as neg. The
negative results of Urobilinogen (URO) will be reported with the respective
data in front of the units.

43

Appendix 5

Barcode reader

The Clarity Urocheck 120 Barcode reader is a laser barcode scanner. The Barcode
reader connects to the analyzer to scan the patient (ID) barcode numbers on the
specimen containers. The Barcode reader can scan the following:

Code 39 (Standard/ Full ASCII)

Codabar (NW-7)

Code 128

Italy Pharmacode

UPCA

EAN 128

French Pharmacode

UPCE

MSI

Industrial 25

EAN8

Plessey

Interleave 25

EAN13

Telepen

Matrix 25

Code 93

RSS

Note:

A maximum of 20 characters can be read by the barcode reader,

displayed, stored, and transmitted by the analyzer.

Warning:

The Barcode reader is a Class 2 LED Product.

DO NOT stare into the beam.

44

Appendix 6
Product Name

Product Code

Catalog
Components

Clarity Urocheck 120 Urine

Clarity Urocheck 120 Urine

Analyzer

Analyzer
Strip Holder
Printer Paper Rolls
Fuses (2.0A)
Power Cord
Quick Start Guide
Instruction Manual

DTG-UAM

Clarity Urocheck 120 Urine

Clarity Urocheck 120 Urine

Analyzer with Barcode reader

Clarity Urocheck Urine

Analyzer Barcode reader
Clarity Urocheck Urine
Analyzer Printer Paper Rolls
Clarity Urocheck Urine
Analyzer Printer Paper Rolls
with Sticky Label
Clarity Urocheck 120 Urine
Analyzer Data Transfer kit

Analyzer
Strip Holder
Printer Paper Rolls
Fuses (2.0A)
Power Cord
Quick Start Guide
Instruction Manual
Barcode reader (RS232C)
Serial Splitter Cable (RS232C)
Barcode reader (RS232C)
Serial Splitter Cable (RS232C)

DTG-UAMB

DTG-UABC

Quantity
1
2
2
2
1
1
1
1
2
2
2
1
1
1
1
1
1
1

DTG-UAPPR

Thermal Paper

DTG-UASPPR

Thermal Paper with Sticky Label

Data Transfer Cable (USB)

Package Insert

DTG-UADTC

45

Appendix 7 Index of Symbols

QC

Attention, see
instructions for
use

Manufacturer

Authorized
Representative

For In vitro
diagnostic use
only

Lot Number

Catalog #

Store between
0-40C

Tests per Kit

Serial Number

Keep away from

sunlight and heat

Use by

Serial Port

Keep Dry

Fragile, handle
with care

This Side Up

Continuous Test

Auto-print is on
Internal printer is
used

Auto-print is off
External printer
is used

Auto-print is on
External printer
is used

USB Port

25 Pin Parallel
External Printer
Port

Fuses type

Power Socket

Grounding

QC Lockout

Barcode reader

Strip Lockout

46

Appendix 8

Warranty

Please complete the warranty card included in the packaging. Mail it to Clarity
Diagnostics, LLC to register your purchase within one year of purchase.
For your records, write the purchase date of your starter kit here:

Note:

This warranty applies only to the analyzer in the original purchase.

It does not apply to the other materials included with the analyzer.

Clarity Diagnostics, LLC warrants to the original purchaser that this analyzer will be
free from defects in materials and workmanship for a period of one year (12 months).
The one year starts from the date of original purchase or installation (except as noted
below). During the stated one year period, Clarity Diagnostics shall replace the unit
under warranty with a reconditioned unit or, at its option, repair at no charge a unit that
is found to be defective. Clarity Diagnostics shall not be responsible for shipping
charges incurred in the repair of such an analyzer.
This Warranty is subject to the following exceptions and limitations:
This warranty is limited to repair or replacement due to defects in parts or workmanship.
Parts required which were not defective shall be replaced at additional cost. Clarity
Diagnostics shall not be required to make any repairs or replace any parts that are
necessitated by abuse, accidents, alteration, misuse, neglect, failure to operate the
analyzer in accordance with the operations manual, or maintenance by anyone other
than Clarity Diagnostics. Furthermore, Clarity Diagnostics assumes no liability
from malfunction or damage to analyzers caused by the use of strips other than strips
manufactured by Clarity Diagnostics. Clarity Diagnostics reserves the right to
make changes in the design of this analyzer without obligation to incorporate such
changes into previously manufactured analyzers.
Disclaimer of Warranties
This warranty is expressly made in lieu of any and all other warranties express or
implied (either in fact or by operation of law) including the warranties of merchantability
and fitness for use, which are expressly excluded, and is the only warranty given by
Clarity Diagnostics.
Limitations of Liability
In no event shall Clarity Diagnostics be liable for indirect, special or consequential
damages, even if Clarity Diagnostics has been advised of the possibility of such
damages.
For warranty service, please contact Clarity Diagnostics
485-7877.

47

Technical Support at 1-(877)

Clarity Urocheck 120 Urine Analyzer Warranty Card

Please complete this warranty card and mail it to Clarity Diagnostics, LLC to
register your purchase within one year of purchase. Refer to Appendix 8
Warranty in the Instruction Manual for details and terms of the product warranty.

Date of
Purchase

Purchaser

Analyzer Serial Number (e.g. SN

0000000. See label on back of
analyzer)

Organization Name

Address

Telephone Number

Email address

Purchased from/Distributor name:

48