Table of Contents
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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 ........................................................................................................... 5
Test Settings ..........................................................................................................5
Type of Strip ............................................................................................................... 5
Mode .......................................................................................................................... 6
Test Number............................................................................................................... 6
Continuous Test ......................................................................................................... 7
Operator ID ................................................................................................................ 7
Units........................................................................................................................... 7
Analyzer Configuration.........................................................................................7
Printer Setup .............................................................................................................. 7
Sound......................................................................................................................... 8
Barcode reader .......................................................................................................... 9
Language ................................................................................................................... 9
Date/Time................................................................................................................... 9
Auto Number Reset.................................................................................................. 10
Database...............................................................................................................10
Clear all Records.......................................................................................................11
Locate Record...........................................................................................................11
View Current Record.................................................................................................11
Self Test................................................................................................................12
QC Test .................................................................................................................12
QC Setup ................................................................................................................. 12
Run QC Test............................................................................................................. 13
Setting the QC Values.............................................................................................. 14
User Login............................................................................................................14
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 ....................................................23
Strip Test - Single Test Mode with Barcode reader .................................................. 23
Strip Test - Continuous Test Mode with Barcode reader.......................................... 24
Urine Controls QC Testing .................................................................................26
Strip Preparation ...................................................................................................... 26
Urine Control Test Procedures ................................................................................. 27
QC lockout ...........................................................................................................27
Section 6 Data/Communication ............................................................................................... 29
External Printer ........................................................................................................ 29
Barcode reader ........................................................................................................ 29
Section 7 Quality Control ......................................................................................................... 30
Section 8 Maintenance ............................................................................................................. 31
Loading Printer Paper.........................................................................................31
General Cleaning.................................................................................................32
Daily Cleaning......................................................................................................32
Remove the Strip Holder .......................................................................................... 32
Clean the Strip Holder .............................................................................................. 32
Load the Strip Holder ............................................................................................... 32
Return the Strip Holder/Mount to its Internal Position............................................... 33
Sample Deposit Cleaning ...................................................................................33
Strip Holder Sterilization.....................................................................................33
Section 9 Precautions .............................................................................................................. 34
Section 10 Troubleshooting..................................................................................................... 35
Appendix 1 Urine Analyzer Specifications ............................................................................. 36
Appendix 2 Compatible Urinalysis Reagent Strips................................................................ 37
Appendix 3 Urinalysis Reagent Strips Parameter Table ....................................................... 43
Appendix 4 Result Print-Out .................................................................................................... 44
Appendix 5 Barcode reader ..................................................................................................... 45
Appendix 6 Catalog .................................................................................................................. 46
Appendix 7 Index of Symbols.................................................................................................. 47
Appendix 8 Warranty ................................................................................................................ 48
Table of Contents
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Summary of Contents for Fisherbrand AimStrip
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Page 1: Table Of Contents
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 ......................5 Test Settings ......................5 Type of Strip ....................... 5 Mode .......................... -
Page 2: Section 1 Introduction
The AimStrip Urine Analyzer and the CTMI CT-120 Analyzer are intended for use ® ® in conjunction with the AimStrip and Fisherbrand 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. -
Page 3: Section 2 Analyzer Components
Section 2 Analyzer Components Analyzer Component Illustrations Keypad Liquid Crystal Display Printer Cover Paper Release Lever (green color) Printer Roller Printer Paper Printer Cover Pull Printer Paper Access Slot Strip Holder 10. Strip Holder Channel 11. Strip Holder Stop 12. White Calibration Circle 13. -
Page 4: Section 3 Initial Startup
Section 3 Initial Startup 1. Place the analyzer on a level surface. Allow 20 cm on all sides of the analyzer for access. 2. Plug the power cord into a power outlet. Press the power switch (19) located on the back panel to turn the analyzer on. The analyzer will run a self-test. The analyzer will display the screen shown below: 3. - Page 5 Note: The screen will not display if Strip Lockout is not included. 6. If the Self-Test fails, a Failed Screen will be displayed. The analyzer cannot be operated. Press the power switch off then on again to re-test. Refer to Section 10 Troubleshooting to correct the failure.
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Page 6: Section 4 Analyzer Setup
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. -
Page 7: Mode
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. -
Page 8: Continuous Test
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. -
Page 9: Sound
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. -
Page 10: Barcode Reader
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. -
Page 11: Auto Number Reset
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. -
Page 12: Clear All Records
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. -
Page 13: Self Test
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. -
Page 14: Run Qc Test
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. -
Page 15: Setting The Qc Values
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. - Page 16 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.
- Page 17 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.
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Page 18: Section 5 Analyzer Operation
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. - Page 19 During testing, the screens will display icons showing the status, options available and prompts for testing: 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 000001 will be 1.
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Page 20: Entering Canister Code
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. -
Page 21: Normal Operation, No Barcode Reader
Only AimStrip and Fisherbrand Urinalysis Reagent Strips work ® with the AimStrip Urine Analyzer and the CTMI CT-120 Analyzer. Use of any other strips will cause inaccurate results. Remove the strips from the closed canister. Use them as soon as possible. - Page 22 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,...
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Page 23: Strip Test - Continuous Test Mode
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. -
Page 24: Normal Operation, Barcode Reader Installed
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. -
Page 25: Strip Test - Continuous Test Mode With Barcode Reader
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. - Page 26 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.
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Page 27: Urine Controls Qc Testing
2. This allows results to be searched for and found easily. Strip Preparation Allow the strip and urine controls to reach room temperature at 15-30ºC (59-86ºF) prior to testing. ® ® Note: Use AimStrip and Fisherbrand Urinalysis Reagent Strips for proper functioning and accurate results. -
Page 28: Urine Control Test Procedures
The following screen will be displayed. The QC symbol will flash. ® ® Note: Use AimStrip and Fisherbrand 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. - Page 29 The analyzer will run a Level 1 QC test first. Refer to the Strip Test section for details on testing. 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.
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Page 30: Section 6 Data/Communication
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. -
Page 31: Section 7 Quality Control
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. 1. A new canister of strips is opened 2. -
Page 32: Section 8 Maintenance
Section 8 Maintenance Loading Printer Paper 1. Pull up on the finger pull area marked to open the printer cover. 2. Place paper roll in the printer box. 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. -
Page 33: General Cleaning
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. -
Page 34: Return The Strip Holder/Mount To Its Internal Position
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 1. -
Page 35: Section 9 Precautions
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 36: Section 10 Troubleshooting
Section 10 Troubleshooting Problem Solutions • Adjust the strip so the strip end is completely touching the Strip Holder Strip Position Improper Backstop and centered in the Strip Holder Channel • Insert strip Strip Missing • Ensure the type of strip used matches the type of strip setting •... -
Page 37: Appendix 1 Urine Analyzer Specifications
Appendix 1 Urine Analyzer Specifications Feature Specifications Methodology Reflectance Photometer Detection Photosensitive diode Single Test Mode: 60 tests/hour Throughput Continuous Test Mode: 120 tests/hour Memory 2000 results Strip Incubation Time 1 minute Detection Wavelengths 525 nm and 635 nm Standard RS232C Port (cable not included), PC Port USB Port (cable not included) Internal thermal printer... -
Page 38: Appendix 2 Compatible Urinalysis Reagent Strips
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 AimStrip and Fisherbrand Urinalysis Reagent Strips with the AimStrip Urine Analyzer and the CTMI CT-120 Analyzer for proper functioning and obtaining accurate results. - Page 39 Performance Characteristics of Urinalysis Reagent Strips ® ® The performance characteristics of the AimStrip and Fisherbrand Urinalysis Reagent Strips have been determined in both laboratory and clinical tests. The following table indicates performance characteristics for each parameter. Sensitivity – ®...
- Page 40 Bayer’s Clinitek 500 Urine Chemistry Analyzer (CM). ® The CLIA waiver study demonstrated that the following performance data of the AimStrip Urine Analyzer in the hands of non-technical users when using only the Quick Reference Guide.
- Page 41 Agreement within +/- 1 block is 97.7% (547/560) with 95% CI: (96.1%; 98.8%). Leukocyte Bayer Clinitek 500 Urine Chemistry Analyzer Total ® AimStrip Urine Analyzer Total The exact agreement between the CM and the WM is 79.6% (446/560) with 95% CI: (76.0%;...
- Page 42 Nitrite Bayer Clinitek 500 Urine Chemistry Analyzer >0 Total ® AimStrip Urine Analyzer >0 Total 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%). Bayer Clinitek 500 Urine Chemistry Analyzer Total ®...
- Page 43 Urobilinogen Bayer Clinitek 500 Urine Chemistry Analyzer Total ® AimStrip Urine Analyzer Total 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%;...
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Page 44: Appendix 3 Urinalysis Reagent Strips Parameter Table
Appendix 3 Urinalysis Reagent Strips Parameter Table Analyte Name (Abbreviation Arbitrary Conventional on Display) ± 100 mg/dL 5 mmol/L Glucose 250 mg/dL 15 mmol/L (GLU) 500 mg/dL 30 mmol/L 1000 mg/dL 60 mmol/L Bilirubin 1 mg/dL 17 µmol/L (BIL) 2 mg/dL 35 µmol/L 4 mg/dL 70 µmol/L... -
Page 45: Appendix 4 Result Print-Out
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. Depending on the type of strip selected, the analyzer recognizes the parameter order and automatically ranks the display and printing sequence of each parameter. -
Page 46: Appendix 5 Barcode Reader
Appendix 5 Barcode reader ® The AimStrip 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: •... -
Page 47: Appendix 6 Catalog
Appendix 6 Catalog Product REF # Components Name Urine Analyzer Strip Holder ® Printer Paper Rolls AimStrip Fuses (2.0A) 51120 Urine Analyzer Power Cord Quick Start Guide Instruction Manual Urine Analyzer Strip Holder ® AimStrip Printer Paper Rolls Urine Fuses (2.0A) -
Page 48: Appendix 7 Index Of Symbols
Appendix 7 Index of Symbols Consult Authorized instructions for Manufacturer Representative For In vitro diagnostic Lot Number Catalog # medical device Store between Tests per Kit Serial Number 0-40°C Keep away from Use by Serial Port sunlight and heat Fragile, handle Keep Dry This Side Up with care... -
Page 49: Appendix 8 Warranty
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. - Page 50 ® AimStrip 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.
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Where is the canister coded located?
The canister code is located on the strip canister of the Fisherbrand AimStrip.
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Someone added an admin passcode but we don't know what it is. Is there a way to reset the machine or passcode?