Section 1 Table of Contents Introduction ................................................................................................................ 1 Section 2 Analyzer Components ............................................................................................... 2 Section 3 Section 4 Initial Startup .............................................................................................................. 3 Analyzer Setup ...........................................................
Section 1 Introduction ® The Pro Advantage Urine Analyzer reads urine test strips. It stores results and prints reports without the need for special training. The Pro Advantage® 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 Pro Advantage® Urine Reagent Strips with the canister barcode for correct results.
Section 2 Analyzer Components Analyzer Component Illustrations 1. Keypad 2. Liquid Crystal Display 3. Printer Cover 4. Paper Release Lever 5. Printer Roller 6. Printer Paper 7. Printer Cover Pull 8. Printer Paper Access Slot 9. Strip Holder 10. Strip Holder Channel 11. 12. 13. 14. 15. 16. 17. 18. 19.
Section 3 Initial Startup Place the analyzer on a level surface. for access. Allow 80*50 cm on all sides of the analyzer Plug the power cord into a power outlet. Press the power switch (19) located on ® the back panel to turn the Pro Advantage Urine Analyzer on. The Pro ® Advantage Urine Analyzer will run a Self-Test. The analyzer will display the screen shown below. “Optical Sensor Failed” will display due to lack of Strip Holder. The Strip Holder Mount will extend for Strip Holder installation.
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.
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.
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. The default test number is from 100001 to 199999. It resets to 100001 each day automatically if Auto Number Reset is set to Yes.
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 symbol will be displayed. per hour.
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.
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 Barcode reader. The Barcode reader icon will be shown.
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.
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 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 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.
Setting the QC Values From the Initial Screen, enter the passcode 420024 to show the QC value setup screen. Press ▲ or ▼ to change the highlighted digit. Press ◄ or ► to move to the digit to be changed. Press ▲ or ▼ to increase or decrease the value. Change each of the analyte QC values in this manner until the desired values are shown. Press ENTER to save the changes and exit the screen. Press PRINT to print the current values.
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.
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.
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.
During testing, the screens will display icons showing the status, options available and prompts for testing: No. 000001 10SG Mode 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. Indicates the proper strip to be tested has 10 test pads. Standard strips available are 2, 4, 7 or 10 test parameters, refer to Appendix 2.
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. 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 code is incorrect, the following screen will show. Press CANCEL to exit to the previous screen.
that a new canister code is required, scan or manually enter a canister code from a new canister to be used, or from the one currently in use. The analyzer will not accept canister codes that have already been entered and will lockout the user until a new canister code is entered. One canister code can be entered for each Type of Strip, and will be managed independently of other strip types by the analyzer.
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: 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.
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.
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. 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.
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. 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.
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.
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 Pro Advantage Urine 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.
When Both QC Tests pass, the “E” at the end of the test number will not be shown.
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. For US customers, call customer service toll free at 1-(800)-838-9502 for details on data transfer. For customers outside the US, contact your local distributor.
Section 7 Quality Control Each lab should use its own standard and procedures for performance. Test known positive and negative specimens/controls at the following events in accordance with local, state, and/or federal regulations or accreditation requirements.
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. The paper comes from the bottom of the roll up into the printer. Caution: The printer will only print on the outside surface of the roll. If placed incorrectly, there will be no printout. For easy printer paper loading, bend the leading edge of the printer paper upward toward the back of the analyzer.
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.
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.
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.
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 Mai
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.
Appendix 2 No. of Parameters 2 4 Compatible Urine Reagent Strips Type of Strip 2P 4P 7 7P 10 10SG Analytes Protein and Glucose Leukocytes, 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.
Performance Characteristics of Urine Reagent Strips ® The performance characteristics of the Pro Advantage Urine Reagent Strips have been determined in both laboratory and clinical tests. The following table indicates performance characteristics for each parameter.
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 Pro Advantage Urine Analyzer over 2 ® month period. The Pro Advantage Urine Analyzer is intended for use in conjunction with the Pro ® Advantage Urine Reagent Strips for detection of the following analytes in urine: Glucose, Blood, Protein, Leukocytes, Nitrite, Bilirubin, Ketone, pH, Specific Gravity, and Urobilinogen.
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 0 268 23 4 0 0 295 15 14 34 17 0 0 65 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 Pro Advantage ® The exact agreement between the CM and the WM is 79.
Nitrite Pro Advantage Bayer Clinitek 500 Urine Chemistry Analyzer ® Urine Analyzer 0 >0 Total 0 387 3 390 >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 Pro Advantage Negative Bayer Clinitek 500 Urine Chemistry Analyzer ® Urine 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.
Urobilinogen Pro Advantage Urine Analyzer Bayer Clinitek 500 Urine Chemistry Analyzer ® 0 1 2 4 8 Total 0 390 14 0 0 0 404 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%).
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.
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 Test Parameters Abnormal Results ID: 0058164578 Date: 2011-08-02 16:54 Operator: 01 No. 000011 neg LEU NIT neg URO 0.2 mg/dL PRO neg pH 5.5 neg BLO SG 1.
Appendix 5 Barcode Reader The Pro Advantage® Urine Analyzer 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.
Appendix 6 Product Name Pro Advantage® Urine Analyzer Product Code Components P080000 Urine Analyzer Barcode Reader P080001 Urine Analyzer Liquid Controls P080002 Urine Analyzer Thermal Printer Paper P080004 Urine Analyzer Data Transfer Cable P080005 Catalog 46 Quantity Urine Analyzer Strip Holder Printer Paper Rolls Fuses (2.
Appendix 7 QC Index of Symbols consult instructions for use Manufacturer For In vitro diagnostic use only Lot Number REF Store between 0-40°C Tests per Kit SN 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
Appendix 8 Warranty Please complete the warranty card included in the packaging. Mail it to your local distributor 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. National Distributing & Contracting, Inc.
Pro Advantage® Urine Analyzer Warranty Card Please complete this warranty card and mail it to your local distributor 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.
