Abaxis VetScan SA, User Manual

Page 1: ...USER S MANUAL v1 1 SOFTWARE F O R V E T E R I N A R Y U S E O N LY ...

Page 2: ...xis com ABAXIS Europe GmbH Bunsenstr 9 11 64347 Griesheim Germany 49 6155 780 21 0 FOR VETERINARY USE ONLY Abaxis and VETSCAN are registered trademarks of Abaxis Inc Reproduction in any form either in print or electronic is prohibited without written permission of Abaxis Inc Copyright Abaxis Inc 2018 1550 7013 Rev B ...

Page 3: ...ntrol or commercial services such as contract services or fee for services It is the responsibility of the purchase end user to acquire any additional intellectual property rights that may be required Abaxis warrants the VETSCAN Sediment Analyzer System against defects in materials and workmanship for 1 year Contact your Abaxis representative for the details of the warranty If any defects occur in...

Page 4: ... and safety requirements of the Machinery directive 2006 42 EC The manufacturer has applied the following standards EN ISO 13485 2012 Medical devices Quality Management systems Requirements for regulatory purposes EN 61326 1 Electrical Equipment for Measurement Control and Laboratory Use EMC Requirements Part 1 General Requirements IEC EN 61010 1 Safety Requirements for Electrical Equipment for Me...

Page 5: ... SA and UA Results 29 Maintenance 30 Maintenance Schedule 31 Cleaner Reagent Cycle 32 Kit Change 33 Empty Waste Container 33 Clean Fan Filter 34 Software Updates 35 Settings 36 Appendix A Installation Overview 37 Appendix B Printer Installation 38 Appendix C UA Installation 39 Appendix D VETSCAN SA Analyzer Specifications 40 Appendix E Symbols 41 Appendix F Safety and Regulatory Compliance 43 Appe...

Page 6: ...y with consistency efficiency reliability and accuracy at the point of care Its high resolution urine sediment images and classification capabilities improve laboratory workflow efficiency and precision When paired with the VETSCAN Urine Analyzer UA the VETSCAN SA UA system provides a comprehensive urinalysis solution ...

Page 7: ...s in urine samples Blood Cells 1 Red Blood Cells 2 White Blood Cells Epithelial Cells 3 Squamous Epithelial Cells 4 Non Squamous Epithelial Cells Casts 5 Hyaline Casts 6 Non Hyaline Casts Bacteria 7 Bacteria Rods 8 Bacteria Cocci Crystals 9 Struvite Crystals 10 Calcium Oxalate Crystals 11 Unclassified Crystals Urine testing on the VETSCAN SA is intended to help detect renal and urinary tract abnor...

Page 8: ...Crystals CaOx dihydrate NTR Unclassified Crystals Crystals other NTR NTR None To Rare Result Bin Definition Few Moderate Many Numerous Result Warnings The VETSCAN SA also displays warnings above the test results in a section titled SA Test Results SA Test Results display text Description Action Completed Nothing abnormal or questionable None Review images SA detected abnormal levels of undefined s...

Page 9: ...wer Cord PN 1550 1005 Optional accessories to be ordered separately not included in the system VETSCAN SA Keyboard PN 1550 1003 VETSCAN SA Mouse PN 1550 1004 VETSCAN SA Display Monitor PN 1550 1007 VETSCAN SA International Power Cords see Appendix G for listings The VETSCAN SA analyzer works with the following reagent cleaner and control VETSCAN SA Reagent Kit PN 1550 9000 VETSCAN SA Cleaner Kit P...

Page 10: ...WARE 1 0 Front Panel 1 Sample probe 2 Blue start paddle Rear Panel 1 Input output panel 2 Power connection 3 Reagent connection panel Side Panels 1 Door latch 2 Power switch 3 Fan filter door WASTE SENSOR 1 2 1 2 1 2 3 3 RINSE A RINSE B ...

Page 11: ... Mouse port 5 Keyboard port WASTE SENSOR 1 4 Input output panel Reagent connection panel 2 3 5 RINSE A RINSE B Note The Ethernet ports have not been enabled yet but will be in a future software update The HDMI and DVI ports are not supported and should not be used to connect a display monitor ...

Page 12: ...ed for the VETSCAN SA system Refer to Appendix for listings of power cords for your region Important The VETSCAN SA analyzer is certified to meet IEC 61010 1 safety standards IEC certified products are safe to use when operated in accordance with the instruction manual This analyzer should not be modified in any way Alteration of this analyzer will Void the manufacturer s warranty Void IEC 61010 1...

Page 13: ...SOFTWARE 1 3 VETSCAN SA Menu When the VETSCAN SA powers on the top menu has three selections Measure is for running samples Database is for reviewing previous tests run Tools is for changing settings and maintenance of the analyzer ...

Page 14: ...ides the user through running a test using images and text 2 SA Images Panel images captured at end of sample analysis 3 Sample Entry Panel where a user enters in all the inputs related to the sample 4 SA Results Panel results classification of particles from the images captured 5 UA Results Panel results received from the UA analyzer 2 4 3 5 1 ...

Page 15: ... VETSCAN UA Use fresh well mixed urine Urine samples may be tested immediately after collection up to one hour post collection if stored at room temperature If urine samples are not tested within one hour of collection samples may be refrigerated 36 46 F 2 8 C for up to 4 hours Cold samples must be warmed to room temperature prior to testing Dilute the sample if necessary A dilution should be cons...

Page 16: ...d after the measurement All other inputs are optional and may be edited or entered after the test has been completed Once a test begins the measurement cannot be canceled There are three test workflows that can be initiated on the VETSCAN SA two of which require a VETSCAN UA connected to the SA Since there are two strip types UA10 and UA14 on the VETSCAN UA five unique Test Types can be selected A...

Page 17: ...and appropriate for most samples Diluted samples are to be used on the SA analyzer only If diluting a sample reserve undiluted sample for UA testing 6 Click Run 7 Mix urine sample by gently inverting 8 Place tube below sample probe and press blue start paddle 1 Hold the sample below the sample probe leaving a gap to the probe tip to allow the sample probe to aspirate air prior to moving down for s...

Page 18: ...down timer reaches 35 as the Strip Tray will begin to slide into the analyzer The UA analyzer will time the reactions and scan when appropriate WARNING If the Strip Tray has already moved into the analyzer to start scanning before the strip is placed in the tray an error will be reported on the UA and sent to the SA The test will be changed to a SA only test While measuring the SA screen is locked...

Page 19: ...g a refractometer 4 Select Test Type SA 5 Select Dilution if necessary Dilute the sample and select correct dilution Undiluted is the default setting and appropriate for most samples 6 Click Run 7 Mix urine sample by gently inverting 8 Place tube below sample probe and press blue start paddle 1 Hold the sample below the sample probe leaving a gap to the probe tip to allow the sample probe to aspir...

Page 20: ...er on UA strip If incorrect the UA test can be canceled by pressing the UA Back button 8 Press Test Test Tube icon button to start test Countdown timer appears Perform the next three steps before the timer reaches 35 9 Apply urine sample to strip Use a dropper pipette to drop urine over entire strip completely wetting each pad Alternatively strip may be dipped into urine sample completely wetting ...

Page 21: ...process Do not disconnect UA from SA during testing process The UA analyzer can operate independently from the SA However this is not advised if combined urinalysis reports are desired or if UA test results are needed to be stored in the SA database Operating the UA independently from the SA indicates that the test was not initiated from the SA or that the UA was disconnected from the SA If UA tes...

Page 22: ...nually printed via the Print button at the bottom left of the Measure screen or re printed later from the Database screen SA Results displayed on Measure screen after test completed Click New to run next test Click Save to store changes when inputting or altering optional fields which includes Patient Name Doctor Collection Method Color Clarity and Specific Gravity after run has been completed Cli...

Page 23: ... Use arrows to page through images SA Image Views 1 Full results view 2 x16 image group 3 x4 image group 4 Zoomed in image Up to 6 images will display with red Print text on them These 6 images will be printed on the printout To modify and select different images right click on any image and select Cancel print image or Add print image The newly selected image will replace the first auto selected ...

Page 24: ... Warning 5 Results Possible short sample UA Results Panel The UA results from the urine chemistry test are shown on the UA Results Panel by Parameter Value and Unit The test results are classified into semi quantitative bins See Appendix J for all the bins grouped by test analyte UA Results Panel Examples 1 Results from UA14 strip test 2 Results from UA10 strip test 3 UA error during a SA UA measu...

Page 25: ...re or Database menu Also a PDF may be saved to an external flash drive using Export button from Print preview screen accessed from Measure or Database menu Urinalysis Printout VETSCAN SA images Patient and doctor info Physical characteristics of sample and specific gravity VETSCAN SA results Dilution VETSCAN SA warning VETSCAN UA results Clinic information Time stamp for when report was printed VE...

Page 26: ...ill be saved and displayed with the new SA test values SA Results displayed on Measure screen after test completed If a retest on the SA is not desired just click Save If a retest is desired the initial SA test data will not be saved to the Database Follow these steps to retest 1 Click Retest button all the inputs to the sample will automatically be populated 2 Select Dilution if necessary Dilute ...

Page 27: ...spirate air prior to moving down for sampling 2 Ensure sample probe touches tube bottom and maintains contact until the probe starts to move back up While measuring the SA screen is locked and navigation to other screens is prohibited Also the SA status indicator light top right of the SA Results Panel will display yellow during measurement process During a SA Retest of a SA UA result the complete...

Page 28: ...t ran more than 30 days prior is needed Database Menu 1 No selection 2 Test selected Search allows results stored in the database to be located by date range Patient ID Patient Name or Test Type Save is available to store changes when inputting or altering optional fields which includes Patient Name Doctor Collection Method Color Clarity and Specific Gravity Print provides a print preview of the t...

Page 29: ...result first in the Database Click the Match drop down in the UA Results Panel and select the correct UA patient result Click Save to lock in combining the two tests and the SA Database will automatically update to show a combined result The results can now be printed and viewed together in one complete urinalysis report The UA result will no longer be shown as a row in the Database Combining SA a...

Page 30: ...n information reagent lot and expiration last use of Rinse B last use of Cleaner Auto Focus last use and connection information On the right a Warning and Error Handling Table is displayed with Solve and Ignore functions listed on the bottom These functions are quick shortcuts to complete maintenance requirements or handle error conditions that are automatically alerted through the software to the...

Page 31: ... All VETSCAN SA external component parts should be kept clean The outside and inside of the sample probe will be automatically cleaned with Rinse A after each use Rinse B will be run automatically every midnight also Do not use the following chemicals to clean VETSCAN SA parts Exposure to these chemicals may cause plastic parts to crack craze etch or warp Alcohols o Methanol o Ethanol o Isopropyl ...

Page 32: ... Table and click Solve button or 2 Select the Reagents button in the Maintenance section and select Cleaner Follow pop up screens Place Cleaner reagent bottle under the sample probe and press blue start paddle Ensure sample probe touches bottom of bottle and maintains contact until the probe starts to move back up The Cleaner Reagent Cycle takes approximately 5 minutes to complete Additional runs ...

Page 33: ... Kit on the left side of the Tools screen If the Reagent Kit is used past its 2 month open expiration time the SA software automatically alerts that the kit is expired and a new Reagent Kit needs to be installed with an alert in the Warning and Error Handling Table Type Error No Description Time Error E3 Reagent Kit issue Lot not entered or expired YYYY MM DD HH MM SS Note Reagents are lot specifi...

Page 34: ...ently if the analyzer is in an environment with excessive dust or animal hair 1 Remove the Fan Filter do not run sample measurement during this cleaning 2 Rinse Fan Filter with warm water to remove debris Do not remove the foam from the plastic frame 3 Dry the Fan Filter to remove excess water and place it back into the analyzer For replacement Fan Filter contact your local Abaxis representative ...

Page 35: ...Updates The SA Analyzer supports software updates via USB flash drive Abaxis or a local distributor will contact VETSCAN SA customers when a software update is required The software update will be completed by Abaxis or a local distributor representative ...

Page 36: ...ngs buttons are provided 1 Options designed for setting up external printer printer settings and inputting clinic information to be included on printout Also the UA connection settings can be verified See Appendices B and C for instructions 2 About details on VETSCAN SA software versions and serial number ...

Page 37: ...nectors on the rear panel Rinse A Rinse B and Waste each of which is covered with a cap to avoid contamination along with a coaxial BNC Waste Sensor Ensure containers are placed on the same level as the SA Analyzer and all caps are tight and secure Rinse A Green Rinse B Blue Waste Black BNC plug connects to Sensor Keep the tubes unkinked with slack no distortion or folding All the tubes should be ...

Page 38: ...is already installed No other printer drivers are available at this time After the printer has been powered on and connected using USB cable to the SA click the Options button under Tools menu and click Printer 1 Printer Select Printer Model HP OfficeJet Pro 6230 2 Paper size Select A4 or Letter 3 Click Apply Next go to Clinic information 1 Input clinic information to be included on printout 2 Sel...

Page 39: ...port on the back of the SA Do not connect the USB power charger to the third leg of the Y cable UA power is provided from the SA 3 Plug the micro USB end of Y Cable into the UA 4 Power on the UA analyzer On the SA screen the UA status indicator light top right of the UA Results Panel will turn green if connection is successful Also by clicking on the Tools selection from the top menu you can verif...

Page 40: ...ply AC 100 V 240 V Frequency 50 60 Hz Rated Power 150 VA Operational Requirements Temperature 15 30 C 59 86 F Relative Humidity 85 Barometric Pressure 75 0 kPa 106 0 kPa Transport and Storage Requirements Temperature 10 55 C 14 130 F Relative Humidity 95 Barometric Pressure 75 0 kPa 106 0 kPa Display Monitor VGA connection 17 inch LCD resolution 1280 x 1024 Analyzer Software Language English ...

Page 41: ...hazardous situation which if not avoided could result in minor or moderate injury or damage to the equipment Corrosive Concentrated solution of strong acids or alkalis Wear gloves and eye protection when using corrosive Potential Biohazard Risk Treat as biohazard Use standard safety proce dures Manufacturer of record Date of manufacture Authorized Representative in the European Community Denotes c...

Page 42: ... lift Required 2 people to lift package of estimated 60 80 lbs 27 36 kg FOR VETERINARY USE ONLY For Veterinary Diagnostic Use only Not for use for humans SN Serial number Catalogue number list number or reference Lot number of reagent or control Expiration date of product Expiration date of product once opened 2 months Health Industry Bar Code standards ...

Page 43: ...irements Class A EN 61326 2 6 2013 Electrical Equipment for Measurement Control And Laboratory Use EMC Requirement Part 2 6 Particular Requirements In Vitro Diagnostic IVD Medical Equipment FCC Part 15 Subpart B 2016 FCC Warnings and Notes Warning Changes or modifications to this unit not expressly approved by Abaxis could void the user s authority to operate the equipment Note This equipment has ...

Page 44: ...CAN SA Control Kit 750 1500 VETSCAN External Printer 1980 0026 USB Printer Cable 1550 1006 USB Extension Cable 1100 UK Power Cable UK 1100 JP Power Cable Japan 1100 EU Power Cable Europe 1100 AU Power Cable Australia 1100 DN Power Cable Denmark 1100 CH Power Cable Switzerland 1100 IT Power Cable Italy 1100 IL Power Cable Israel 1500 8020 VETSCAN UA Y Cable 1500 0014 25 VETSCAN UA14 Strips 1550 001...

Page 45: ...Causes Possible Solutions SA analyzer power and Green Light on SA Power Switch is OFF 1 SA analyzer not powered on 2 SA analyzer not plugged in 3 No power from power outlet 4 SA plug or cord damaged 1 Turn on SA power switch 2 Check SA analyzer power cord is firmly connected to back panel of SA and ensure SA analyzer is connected into appropriately grounded power outlet 3 Confirm power outlet by p...

Page 46: ...oard cable 2 Replace keyboard Printer Error 1 Printer power LED not on 2 Printer not selected on Tools screen 3 Printer not shown as option to select in Settings Option Print 4 Printer power cord not plugged in 5 No power at power outlet 6 Power cord damaged 7 USB Printer cable not plugged in correctly 8 USB Printer cable damaged 9 Printer error on SA Display 10 Printer Error only at Printer Flash...

Page 47: ...gging Y Cable into another SA USB port UA analyzer not connecting to SA 1 UA analyzer not powered on 2 UA not plugged into back of SA 3 UA Y Cable damaged 4 SA USB port damaged 5 UA settings not correct on SA analyzer 1 Turn on UA 2 Plug UA connected Y Cable into USB port on back of SA analyzer 3 Try another Y Cable 4 Try plugging Y Cable into another SA USB port 5 Verify settings by selecting VET...

Page 48: ...Insufficient space on the disk Contact Abaxis representative Warning W11 Cleaner use is due Run Cleaner cycle now Warning N A Warning or Error Please go to Tools to correct There is one or more Warnings or Errors shown on the Tools Screen that needs to be corrected before a run can occur After clicking Run or pressing blue start paddle NOTE The SA Status Light color on the Measure screen will be c...

Page 49: ...well as technical resources on a variety of applications related to the VETSCAN SA analyzer Resource How to Contact Local Authorized Abaxis Distributors Find local Abaxis authorized Distributors on the Abaxis website www abaxis com Technical Information Find technical information package inserts and manuals on the Reference Center on the Abaxis website www abaxis com Technical Support For technica...

Page 50: ...her Clarity Clear Slightly turbid Moderately turbid Extremely turbid Users can also input a Specific Gravity of each sample for the medical record Specific Gravity 1 0xx 1 000 minimum 1 099 maximum Also the SA allows the user to dilute the sample with normal saline and will automatically calculate results based on the dilution selected The SA defaults to Undiluted but gives users 3 additional sele...

Page 51: ...8 depending on level of turbidity c Select appropriate dilution from drop down field on the SA Opaque Cloudy Very Cloudy Clear 2 Is the sample brown or red in color a A brown or red color suggests hematuria b If yes dilute 1 8 prior to running the sample c Select 1 8 dilution from drop down field on the SA Post analysis The analyzer will also prompt for a dilution after a sample run if a TNTC resu...

Page 52: ... Due to no prior published veterinary ranges in urinary cells μL suggested ranges are converted from reference 1a using conversion formula with VETSCAN SA specific variables on file at Abaxis Formula cited in Conrad dos Santos Juliana et al Evaluation of Urinalysis Parameters to Predict Urinary Tract Infection Brazilian Journal of Infectious Disease 2007 11 5 479 481 2 An increased number of eryth...

Page 53: ...6 26 4 PRO CR no units CON SI same Dog Other 0 2 0 2 to 0 5 0 5to 2 0 2 0 Cat 0 2 0 2 to 0 4 0 4to 2 0 2 0 Color no units Transparent Yellow Orange Red Green Other Not applicable USER S MANUAL 31 APPENDIX B UA RESULTS BINS ANALYTE RESULT TYPE SPECIES SEMI QUANTITATIVE SYMBOL AND CONCENTRATION LEU Semi Quantitative 1 2 3 Cell μL CON 0 15 70 125 500 Cell μL SI 0 15 70 125 500 KET Semi Quantitative 1...

Page 54: ...Abaxis Inc 3240 Whipple Road Union City CA 94587 USA Tel 1 800 822 2947 ABAXIS Europe GmbH Bunsenstr 9 11 64347 Griesheim Germany Tel 49 6155 780 21 0 1550 7013 Rev B www abaxis com ...