Product Manual

ManualsBrandsClarity Diagnostics ManualsAnalyzersUrocheck 120C Analyzer

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 .................................................................................................................................. 11

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

QC Test ............................................................................................................................................... 11

QC Setup ................................................................................................................................................... 11

Run QC Test ............................................................................................................................................... 13

Setting the QC Values ................................................................................................................................ 13

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

ID Admin..................................................................................................................................................... 14

Section 5 Analyzer Operation ..................................................................................................................... 17

Entering Canister Code ..................................................................................................................... 19

Normal Operation, no Barcode reader ............................................................................................ 20

Sample/Strip Preparation ........................................................................................................................... 20

Strip Test – Single Test Mode ..................................................................................................................... 20

Strip Test – Continuous Test Mode ............................................................................................................. 22

Normal Operation, Barcode reader installed .................................................................................. 24

Strip Test – Single Test Mode with Barcode reader .................................................................................... 24

Strip Test – Continuous Test Mode with Barcode reader ............................................................................ 25

Urine Controls QC Testing ................................................................................................................ 27

Strip Preparation ........................................................................................................................................ 27

Urine Control Test Procedures ................................................................................................................... 27

QC lockout .......................................................................................................................................... 28

Section 6 Data/Communication ................................................................................................................... 30

External Printer .......................................................................................................................................... 30

Barcode Reader ......................................................................................................................................... 30

Service and Support ................................................................................................................................... 30

Section 7 Quality Control ............................................................................................................................ 31

Section 8 Maintenance ................................................................................................................................ 32

Loading Printer Paper ....................................................................................................................... 32

General Cleaning ............................................................................................................................... 33

Daily Cleaning .................................................................................................................................... 33

Remove the Strip Holder ............................................................................................................................ 33

Clean the Strip Holder ................................................................................................................................ 33

Load the Strip Holder ................................................................................................................................. 33

Return the Strip Holder/Mount to its Internal Position ................................................................................. 34

Sample Deposit Cleaning ................................................................................................................. 34

Strip Holder Sterilization ................................................................................................................... 34

Section 9 Precautions .................................................................................................................................. 36

Section 10 Troubleshooting ........................................................................................................................ 37

Appendix 1 Urine Analyzer Specifications ................................................................................................. 38

Appendix 2 Compatible Urinalysis Reagent Strips .................................................................................... 39

Appendix 3 URS Parameter Table ............................................................................................................... 45

Appendix 4 Result Print-Out ....................................................................................................................... 46

Appendix 5 Barcode Reader ....................................................................................................................... 47

Appendix 6 Catalog ...................................................................................................................................... 48

Appendix 7 Index of Symbols ..................................................................................................................... 49

Appendix 8 Warranty ................................................................................................................................... 50

Summary of content (52 pages)

PAGE 1
Table of Contents Section 1 Introduction ................................................................................................................................... 1 Intended Use ................................................................................................................................................ 1 Section 2 Analyzer Components .................................................................................................................
PAGE 2
Section 1 Introduction The Clarity Urocheck 120C Urine Analyzer reads urine test strips. It stores results and prints reports without the need for special training. The Clarity Urocheck 120C 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.
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Section 2 Analyzer Components Analyzer Component Illustrations 1 2 3 4 5 6 7 8 Keypad Liquid Crystal Display Printer Cover Printer Roller Printer Paper Printer Strip Holder Strip Holder Channel 9 10 11 12 13 14 15 16 2 Strip Holder Stop White Calibration Circle Strip Holder Mount USB Port External Printer Port Standard RS232C Port Power Socket Power Switch
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Section 3 Initial Startup Place the analyzer on a level surface. Allow 80x50 cm on all sides of the analyzer for access. Plug the power cord into a power outlet. Press the power switch (16) located on the back panel to turn the Clarity Urocheck 120C Urine Analyzer on. The Clarity Urocheck 120C Urine Analyzer will run a Self-Test. The analyzer will display the screen shown below. Turn the Power Switch on. If the Self-Test passes, the Initial Screen will be shown.
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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.
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Note: Ensure the type of strip selected corresponds with the strip to be used. If it does not, an error message will be displayed. Mode There are three test mode options. Press ENTER when Mode is selected to change the Mode. Note: 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. It resets to 1 every day automatically if Auto Number Reset is set to Yes. STAT Test Use for emergency urine testing.
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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.
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Press ▲ or ▼ to move → to select the options listed below. Press ENTER to change the option as shown below. 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. will display External prints the results on an external printer. The symbol on all screens.
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Off – internal speaker is Off in all cases. 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 screen will return to the Main Menu. 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 will be shown. If the optional Barcode Barcode reader.
PAGE 10
Time Format Select Time Format and press ENTER to cycle to 24 Hour or 12 Hour. 12 Hour displays the time with am/pm symbols. 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.
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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. 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.
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Press CANCEL to return to the previous screen. Additional records can be located, reviewed or printed. View Current Record Select Current Record and press ENTER to show the data from the current or last record. 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. A results screen will display the results of each test.
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QC Lockout Select QC Lockout and press ENTER to cycle the options Off or On. Off disables the QC lockout function. The QC symbol and Setup Options are not displayed. On enables the QC lockout function. The QC symbol is displayed. QC Lockout timing can be set for Every 8 Hours, Daily, Weekly or Monthly. 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.
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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. When a QC test is run for the first time, the analyzer will show the screen below if QC values have not been set up.
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On entry to this screen for the first time, leave the Passcode blank and press ENTER. 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.
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Press CANCEL to keep the existing passcode and exit. Scan or enter a valid Passcode and press ENTER to accept and exit. User Login will be enabled. 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. Press ENTER for the Passcode screen. Scan or enter a new Passcode. Press ENTER to save the settings and exit. Press CANCEL to cancel the settings and exit.
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CLEAR Press CLEAR from the Initial Screen to logout and display the Login Screen shown above. If you forgot the passcode, please call 1-(877) 485-7877 for technical assistance.
PAGE 18
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. CLEAR Enter the ID and enter or scan the Passcode. Press ENTER to run the analyzer. Press CLEAR to return to the login screen. If the Passcode is incorrect, the analyzer will indicate a passcode error. After 3 seconds, the screen will return to the login screen.
PAGE 19
Press START on the Initial Screen to test strips. Check all settings and strip types before testing. 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.
PAGE 20
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. The screen below will be displayed. 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.
PAGE 21
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. The number under will be increased accordingly. Note: Refer to the following for more information on the Strip Lockout function.
PAGE 22
Once START is pressed, the screen below will show. 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.
PAGE 23
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: In order to avoid contamination of the strip holder and/or the optical sensor, make sure that the strip holder is fully extended and at a standstill before placing or removing a urine strip from the strip holder. When the countdown clock on the display reaches 1, the Strip Holder will carry the strip inside and begin testing.
PAGE 24
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.
PAGE 25
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.
PAGE 26
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. 02-16-17 If Auto-print is Off, press PRINT from the results screen to print results. Press CANCEL to return to the previous barcode entry screen. Strip Test – Continuous Test Mode with Barcode reader If Barcode reader is On and is displayed, samples are tested in batch mode.
PAGE 27
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. Press PRINT to print the list of IDs. CANCEL to exit to the previous screen. Press START to save the IDs and return to the previous screen. Up to 100 barcodes can be read. The screen will indicate how many barcodes have been read. Note: Do not change Barcode reader or Test number settings before all barcodes have been processed.
PAGE 28
When the test is complete, the Results Screen will show briefly. The next strip can be placed on the Strip Holder. 02-16-17 Stop testing by pressing CANCEL when the prompt appears. All other testing procedures are the same as testing with no barcode. 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.
PAGE 29
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 for proper functioning and accurate results. If it is the first time to run the QC test, refer to the section on Setting the QC Values to set up QC test values. Press CANCEL to return to the Initial Screen. If canceled, the analyzer will change the test mode to STAT.
PAGE 30
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. When Both QC Tests pass, the “E” at the end of the test number will not be shown.
PAGE 31
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. External Printer The RS232 port can connect to an optional external printer for printing data. Barcode Reader The RS232 port can also connect to an optional Barcode reader.
PAGE 32
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 Liquid Controls, Product code: CD-UCTL30.
PAGE 33
Section 8 Maintenance Loading Printer Paper Open the printer cover by pulling up on the tab. Place the new paper roll into the printer paper compartment with the paper unrolling from underneath and towards the compartment wall. Pull about 4 inches or 10 cm of paper past the top edge of the paper compartment Note: Do not feed paper underneath the paper roller. Close the printer paper compartment by clicking the cover back into its original position.
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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.
PAGE 35
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 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.
PAGE 36
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.
PAGE 37
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.
PAGE 38
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 Printer does not work Main Control Unit Fa
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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.
PAGE 40
Appendix 2 Compatible Urinalysis Reagent Strips No.
PAGE 41
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.
PAGE 42
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 120C Urine Analyzer over 2 month period.
PAGE 43
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%). Leukocytes Bayer Clinitek 500 Urine Chemistry Analyzer 0 15 70 125 500 Total Clarity 0 268 23 4 0 0 295 Urocheck 15 14 34 17 0 0 65 120C Urine 70 8 10 53 7 3 81 Analyzer 125 1 0 4 80 22 107 500 0 0 0 1 11 12 Total 291 67 78 88 36 560 The exact agreement between the CM and the WM is 79.
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Nitrite Bayer Clinitek 500 Urine Chemistry Analyzer 0 >0 Total Clarity Urocheck 0 387 3 390 120C 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%). Negative percent agreement was 93.9% (387/412) with 95% CI: (91.2%; 96.0%). pH Clarity Urocheck 120C Urine Analyzer Bayer Clinitek 500 Urine Chemistry Analyzer 5 5.5 6 6.5 7 7.5 8 8.5 9 Total 5 4 22 3 1 0 0 0 0 0 30 5.
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Urobilinogen Bayer Clinitek 500 Urine Chemistry Analyzer 0 1 2 4 8 Total Clarity Urocheck 0 390 14 0 0 0 404 120C Urine Analyzer 1 0 41 7 1 0 49 2 0 0 22 18 0 40 4 0 0 0 26 19 45 8 0 0 0 0 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%).
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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) URS Parameter Table Arbitrary Conventional neg 15 Leu/µL 70 Leu/µL 125 Leu/µL 500 Leu/µL 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/µL 25 Ery/µL 80 Ery/µL 200 Ery/µL 1.000 1.005 1.010 1.015 1.020 1.025 1.
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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: 02-16-2017 16:54 Operator: 01 No. 000011 *GLU 1+ 250 mg/dL neg BIL KET ± 5 mg/dL SG 1.030 neg BLO pH 5.5 PRO neg URO 0.
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Appendix 5 Barcode Reader The Clarity 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.
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Appendix 6 Product Name Catalog Number Catalog Components Quantity 2 1 1 1 4 Clarity Printer Paper Rolls DTG-UAPPR Clarity Urocheck 120C Urine Analyzer Printer Paper Rolls Power Cord Quick Start Guide Instruction Manual Thermal Paper Clarity Sticker Paper Rolls DTG- UASPPR Sticker Paper 4 10 mL Level 1 3 10 mL Level 2 3 Product Insert 1 Clarity Urocheck 120C Urine Analyzer Clarity Urine Liquid Controls CLA-U120C CD-UCTL30 48 1
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Appendix 7 Index of Symbols Attention, see instructions for use Manufacturer Authorized Representative For In vitro diagnostic use only Lot Number Catalog # Store between 0-40°C 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
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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.
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Clarity Urocheck 120C 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 Analyzer Serial Number (e.g. SN 0000000.