Fisherbrand AimStrip, Manual

Page 1: ...ation 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 Cont...

Page 2: ...nalyzer 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...

Page 3: ...r Release Lever green color 5 Printer Roller 6 Printer Paper 7 Printer Cover Pull 8 Printer Paper Access Slot 9 Strip Holder 10 Strip Holder Channel 11 Strip Holder Stop 12 White Calibration Circle 13...

Page 4: ...ailed The Strip Holder Mount will be extended Turn off the Power Switch 4 Remove the Strip Holder from the plastic packaging Position the white Calibration Circle up and towards the back of the analyz...

Page 5: ...again to re test Refer to Section 10 Troubleshooting to correct the failure Ensure the Strip Holder is installed properly 7 Press MENU to access the Test Settings Analyzer Configuration Database func...

Page 6: ...2 for actual Analyzer Read Type of Strips Type of Strip 54100 4LN 58100 51100 10SG Mode Routine STAT QC Test Number User selected number Continuous Test On Off single test Operator ID If User Login i...

Page 7: ...omatically 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 contr...

Page 8: ...d 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 un...

Page 9: ...e Labs Technical Support for a list of printers and printer cables that can be used Print Darkness Print darkness ranges from 1 to 9 The darkest is 9 After 9 it reverts back to 1 The default is 5 Prin...

Page 10: ...ith and press ENTER to save changes The screen will return to the Main Menu Language Select Language and press ENTER to change the current language Each time ENTER is pressed the language changes Sele...

Page 11: ...n 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 Normal STAT or QC modes each day If No the test numb...

Page 12: ...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 curren...

Page 13: ...ults of each test 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...

Page 14: ...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 d...

Page 15: ...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 User Login Press ENTER from the Initial Screen to s...

Page 16: ...scode 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 passcod...

Page 17: ...een 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...

Page 18: ...e Passcode is correct the analyzer will display the Initial Screen The logged in ID will be shown 11 20 or 100 The user ID will be 11 20 for Operators This provides access to operate the analyzer chan...

Page 19: ...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 t...

Page 20: ...umber 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...

Page 21: ...odes 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 st...

Page 22: ...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...

Page 23: ...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 STA...

Page 24: ...ime 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 re...

Page 25: ...e test Press MENU to change the current testing mode After the barcode is entered ID will display Review the ID before testing the strip Press START after the ID has been entered to display the next s...

Page 26: ...ow the next sample to be tested Press START to begin the batch mode 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 re...

Page 27: ...is complete the Results Screen will show briefly The next strip can be placed on the Strip Holder Stop testing by pressing CANCEL when the prompt appears All other testing procedures are the same as t...

Page 28: ...ult will be printed If the QC test Fails please contact Germaine Laboratories Inc Technical Support QC lockout When QC lockout is turned On the user will be notified when a QC test is required The fol...

Page 29: ...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 Le...

Page 30: ...uitable software Please contact Germaine Labs Technical Support for details on the data transfer External Printer The RS232 port can connect to an optional external printer for printing data Please co...

Page 31: ...operator uses the analyzer 3 Test results seem inaccurate 4 After performing maintenance or service on the analyzer If the QC tests do not provide expected results perform the following checks 1 Ensur...

Page 32: ...f the printer paper through the feed and the printer paper will now easily feed through the Printer Roller 3 A green Paper Release Lever is located near the Printer Roller Press and push the back end...

Page 33: ...sing 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 Please contact...

Page 34: ...it to its original position as described above Strip Holder Sterilization 1 Remove the Strip Holder and repeat Daily Cleaning above 2 Clean the Strip Holder using a lint free non absorbent cotton swab...

Page 35: ...id interference with the Strip Holder 6 Keep the unit clean Wipe it frequently with a soft clean and dry cloth Use fresh water when needed 7 Do not clean the unit with substances such as gasoline pain...

Page 36: ...the Power Switch off then on Perform a Self Test Refer to Manual Self Test section Optical Sensor Failed Ensure the Strip Holder is locked onto the Strip Holder Mount correctly The Strip Holder should...

Page 37: ...hermal printer 25 Pin Parallel External Printer Connector Barcode reader Connector USB port External printer optional Barcode reader optional Major Readable Barcodes See Appendix 5 Available Languages...

Page 38: ...kocytes 10 51100 10SG Glucose Bilirubin Ketone Specific Gravity Blood pH Protein Urobilinogen Nitrite and Leukocytes Note Ensure that the type of strip selected corresponds with the strip to be used I...

Page 39: ...thod within 0 005 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 specim...

Page 40: ...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 Bilirubin Bayer Clinitek 500...

Page 41: ...Bayer Clinitek 500 Urine Chemistry Analyzer 0 15 30 100 300 Total 0 265 10 0 0 0 275 15 19 42 13 0 0 74 30 0 9 48 17 0 74 100 0 0 0 42 9 51 AimStrip Urine Analyzer 300 0 0 0 0 86 86 Total 284 61 61 59...

Page 42: ...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 Bayer Clinitek 500 Urine Chemistry Analyzer Specific Gravity 1 0 1 005 1 01 1 015...

Page 43: ...0 0 404 1 0 41 7 1 0 49 2 0 0 22 18 0 40 4 0 0 0 26 19 45 AimStrip Urine Analyzer 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...

Page 44: ...1 020 1 025 1 030 1 000 1 005 1 010 1 015 1 020 1 025 1 030 1 000 1 005 1 010 1 015 1 020 1 025 1 030 Blood BLO 1 2 3 neg 10 Ery L 25 Ery L 80 Ery L 200 Ery L neg 10 Ery L 25 Ery L 80 Ery L 200 Ery L...

Page 45: ...ological significance will be marked with an Arbitrary Results 1 All positive results except pH and Specific Gravity SG will be reported as 1 2 or 3 2 Positive results for pH and Specific Gravity SG w...

Page 46: ...eader 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...

Page 47: ...ter Paper Rolls 2 Fuses 2 0A 2 Power Cord 1 Quick Start Guide 1 Instruction Manual 1 Barcode reader 1 51220 AimStrip Urine Analyzer With Barcode reader Serial Splitter Cable 1 Barcode reader 1 51320 U...

Page 48: ...Kit SN 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 Ext...

Page 49: ...placement due to defects in parts or workmanship Parts required which were not defective shall be replaced at additional cost Germaine shall not be required to make any repairs or replace any parts th...

Page 50: ...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 See label on back of a...