Zoetis vetscan SA, User Manual

Page 1: ...SA Sediment Analyzer USER S MANUAL v1 2 Software For Veterinary Use Only ...

Page 2: ...973 822 7000 www zoetis com Zoetis Belgium S A Rue Laid Burniat 1 1348 Louvain La Neuve Belgium FOR VETERINARY USE ONLY All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted 2020 Zoetis Services LLC All rights reserved 1550 7013 Rev C ...

Page 3: ...rol 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 Zoetis warrants the VETSCAN Sediment Analyzer System against defects in materials and workmanship for 1 year Contact your Zoetis representative for the details of the warranty If any defects occur in t...

Page 4: ... 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 Measurement Control and Laboratory Use Part 1 General Requirements IEC EN 61010 2 081 Particular Requirements for Automatic and Semi Au...

Page 5: ... Cleaner Reagent Cycle 33 Kit Change 34 Empty Waste Container 34 Clean Fan Filter 35 Software Updates 36 Settings 37 Network Configuration Settings 38 Host Configuration Settings 39 Appendix A Installation Overview 44 Appendix B Date and time Settings 45 Appendix C Printer Installation 46 Appendix D UA Installation 47 Appendix E VETSCAN SA Analyzer Specifications 48 Appendix F Symbols 49 Appendix ...

Page 6: ... the native urine sediment with consistent and efficient high quality images at the point of care Combined with the VETSCAN UA for urine chemistry testing it s the complete solution for your in clinic urinalysis needs When paired with the VETSCAN Urine Analyzer UA the VETSCAN SA UA system provides a comprehensive urinalysis solution ...

Page 7: ...hite 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 Urine sediment evaluation on the VETSCAN SA is intended to help detect renal and urinary tract abnormalities It is designed to be utilized in combination with urine ...

Page 8: ...1 0 Range Above Range Units Squamous Epithelial Cells Sq Epithelial NTR 1 50 50 µL Non Squamous Epithelial Cells Non Sq Epithelial NTR 1 50 50 µL Hyaline Casts Hyaline NTR 1 5 5 µL Non Hyaline Casts Non Hyaline NTR 1 5 5 µL Semi quantitative Results Parameter SA Display Semi quantitative Results Bacteria Rods Bacteria Rods NTR Bacteria Cocci Bacteria Cocci NTR Struvite Crystals Struvite NTR Calciu...

Page 9: ...nce of bacteria Review images urine culture sensitivity and or dry prep and interpreted in conjunction with patient history and clinical signs Review Images Multiple Elements Suspected Any of the following 5 scenarios 1 RBC 500 µL 2 RBC 500 µL abnormal levels of undefined sediment 3 RBC 500 µL detected presence of bacteria 4 RBC 500 µL abnormal levels of undefined sediment detected presence of bac...

Page 10: ...SA Power Cord PN 1550 1005 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 PN 15...

Page 11: ...WARE 1 1 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 12: ...thernet ports 2 USB ports 3 VGA monitor port 4 Mouse port 5 Keyboard port WASTE SENSOR 1 4 Input output panel Reagent connection panel 2 3 5 RINSE A RINSE B Note The HDMI and DVI ports are not supported and should not be used to connect a display monitor ...

Page 13: ...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 14: ...SOFTWARE 1 4 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 15: ...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 16: ...our 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 Dilution For a dilution decision chart see Appendix J If a dilution is performed it should be initiated at 1 2 0 4 mL urine 0 4 mL saline and increased accordingly...

Page 17: ...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 18: ...setting and appropriate for all initial analyses on the SA1 Diluted samples are to be used on the SA analyzer only If diluting a sample reserve undiluted sample for UA testing 7 Click Run 8 Mix urine sample by gently inverting Ensure a thoroughly mixed sample 9 Immediately place tube below sample probe and press blue start paddle 1 Hold the sample below the sample probe leaving a gap to the probe ...

Page 19: ...l begin to slide into the analyzer The UA analyzer will time the reactions and scan when appropriate WARNING Ensure the strip has been placed in the tray before the Strip Tray begins to move into the analyzer If a strip is not present in the Strip Tray at the conclusion of the measurement an error will be reported on the UA and sent to the SA The test will be changed to a SA only test While measur...

Page 20: ...Select Test Type SA 6 Select Dilution if necessary Dilute the sample and select correct dilution Undiluted is the default setting and appropriate for all initial analyses on the SA1 7 Click Run 8 Mix urine sample by gently inverting Ensure a thoroughly mixed sample 9 Immediately place tube below sample probe and press blue start paddle 1 Hold the sample below the sample probe leaving a gap to the ...

Page 21: ...ess Test Test Tube icon button to start test Countdown timer appears Perform the next three steps before the timer reaches 35 9 Mix urine sample by gently inverting Ensure a thoroughly mixed sample 10 Apply urine sample to strip Use a dropper pipette to drop urine over entire strip completely wetting each pad Do not leave excess urine on strip for more than 2 seconds Alternatively strip may be dip...

Page 22: ...omes disconnected during testing the UA test will be canceled automatically on the SA and complete as an SA only test If the UA becomes disconnected from the SA during the measurement wait until the SA completes its measurement to reconnect If desired manually send the UA results from the UA to the SA Database by pushing the USB send icon on the UA The UA analyzer can operate interdependently from...

Page 23: ...rom the Database screen Once results are Saved fields including Comments and the 6 selected images cannot be changed in Database SA Results displayed on Measure screen after test completed Click Save to store results Once results are Saved all fields which include Patient Name Doctor Collection Method Color Clarity Specific Gravity and Comments and the 6 selected images cannot be changed in Databa...

Page 24: ... zoom in on the selected image 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 re...

Page 25: ...th No Warnings 2 No SA test measured where N A represents Not Applicable 3 Review images Unclassified Elements Preset 4 Review Images Bacteria Suspected 5 Review Images Multiple Elements Suspected 6 Results with TNTC Dilute and retest Warning 7 Results Possible short sample SA Warning Area SA Sediment Classifications 2 1 SA Warning Area SA Sediment Classifications 4 5 3 SA Warning Area 6 7 SA Sedi...

Page 26: ...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 UA10 strip test 2 Results from UA14 strip test 3 UA error during a SA UA measurement If parameters are toggled OFF on the UA result will display as N A UA Warning Area 1 2 3 UA Chemistry Result ...

Page 27: ... Rods Bacteria Cocci Struvite CaOx dihydrate Dilution SA Test Results SW Reagent Kit Lot NTR None To Rare Comments Time SA SN Test Result Units Ketones Nitrites Urobilinogen Bilirubin Glucose Protein pH Blood Ascorbic Acid Microalbumin Calcium Creatinine Protein Creatinine Urine chemistry results VETSCAN UA Time SW UA SN Test Type Clarity Specific Gravity Collection Method Color Urinalysis Printou...

Page 28: ...uto printed 1 Click Retest button all the inputs to the sample will automatically be populated Patient ID and Species are unchangeable All other inputs can be revised and comments can be added 2 Select Dilution if necessary Dilute the sample and select correct dilution Undiluted is the default setting and appropriate for all samples prior to initial analysis as overdiluting the sample should be av...

Page 29: ... the sample probe to aspirate 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 ...

Page 30: ...atabase Table Use Search button detailed below if results review of test 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 The oldest and newest record dates are automatically entered into the search date range when the pop up is opened Select the desired d...

Page 31: ...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 32: ... including wiping off any sample spills 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 daily at midnight 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 Alcoh...

Page 33: ...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 of Clea...

Page 34: ... 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 Error E3 Reagent Kit issue Lot not entered or expired Note Reagents are lot specific do not transfer Rinse bottles ...

Page 35: ...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 Zoetis representative ...

Page 36: ...Updates The SA Analyzer supports software updates via USB flash drive Zoetis or a local distributor will contact VETSCAN SA customers when a software update is required The software update will be completed by Zoetis or a local distributor representative ...

Page 37: ...d for setting up external printer printer settings date time format 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 3 UA Connect designed to reconnect the VETSCAN UA to the VETSCAN SA ...

Page 38: ...located on the back of the SA analyzer Either port can be used to connect the VETSCAN SA to a network In the SA Network Device configuration Adapter dropdown the network ports are referred to as Upper NW Port and Lower NW Port to correspond with their physical location on the back of the analyzer The VETSCAN SA offers both DHCP dynamic addressing and Static addressing capabilities The SA will defa...

Page 39: ...twork and then Host 1 Enable Send by network port 2 Input the IP address of the Host into the Remote IP field If VETSCAN FUSE is being installed in conjunction with the VETSCAN SA input the VETSCAN FUSE IP address here 3 Input the Local port of the Host for the VETSCAN FUSE enter 65000 4 Input the Remote port of the Host for the VETSCAN FUSE enter 65100 5 Enable Auto Send 6 Press the Connect butto...

Page 40: ...SCAN SA Work List 1 Select the test from the Work List 2 Use similar formatting and content as found on pg 17 Enter physical characteristics of the sample recommended Use the drop down option lists to select gross examination fields for the sample Collection Method Color and Clarity for the medical record 3 Enter specific gravity of the sample recommended Input specific gravity value of the sample...

Page 41: ...ult has been manually printed or Auto Print is On with Auto Send Off Final Result has been saved but not sent to the PIMS and not printed Auto Send Off and Auto Print is off blank Result has been retested with Retest workflow Result has not been printed and has not been sent to PIMS If desired select Print or Send PIMS Practice Information Management System EMR Electronic Medical Record VETSCAN SA...

Page 42: ...ens connectivity is displayed in the bottom right hand corner On the SA Tools Screen Network connectivity status is displayed on the Left Hand side under the Printer Status Any Network Connectivity Errors will be reported on the Tools Screen along with an explanation of the Error ...

Page 43: ... information about connectivity capabilities contact technical support For assistance in the United States and Canada call 1 800 822 2947 toll free phone and select option 2 For Rest of World dial 49 6155 780 210 or contact local Zoetis distributor ...

Page 44: ...onnectors 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 b...

Page 45: ... button under Tools menu Ensure Date and time is selected 1 Time Zone Select time zone 2 Format Select preferred date format Options include yyyy MM dd MM dd yyyy dd MM yyyy 3 Time format Select preferred time format Options include H mm ss and H mm ss tt 4 Date Select date 5 Time Select time 6 Select Apply The analyzer will prompt to restart the software Click Yes ...

Page 46: ...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 47: ...n 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 section from the top menu you can verify softwa...

Page 48: ...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 49: ...esult 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 procedures Manufacturer of record Date of manufacture Authorized Representative in the European Community Denotes conformity to specific European directives Indicat...

Page 50: ... 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 51: ...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 Zoetis could void the user s authority to operate the equipment Note This equipment has ...

Page 52: ...50 9001 VETSCAN SA Cleaner Kit 1550 9002 VETSCAN 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 Ca...

Page 53: ...rdware is not intended to be serviced by operators Contact a Zoetis authorized representative if you suspect a problem inside the analyzer Familiar problems and corrective actions are listed below Error Failure Potential 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 p...

Page 54: ...re is not running 3 Display VGA cable loose 4 Display has failed 1 Confirm if SA power switch is set to on and lit with green light 2 Check if fan of SA analyzer is running on right side panel vent If fan is off the SA software was shut down but the power switch was not turned off Power the SA analyzer off for 30 seconds and then switch back on 3 Check and reconnect Display VGA cable to SA analyze...

Page 55: ...nter cable 9 Correct Printer popup paper out ink out etc 10 See Printer user manual for details Fuzzy or Blurry Images 1 Thermal conditions have changed need to refocus 2 Bubbles in reagents black lines in Images 3 Chamber needs cleaning 1 Run Auto Focus Contact Zoetis representative 2 Run Flush Contact Zoetis representative 3 Run Cleaner Contact Zoetis representative Bacteria showing up in all sa...

Page 56: ...B 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 VETSCAN UA after clicking Options button under Tools menu and contact Zoetis representative 6 Verify UA Settings by selecting Settings on UA screen USB Send is ON UA results not transferring over to SA 1 UA analyzer operated independently from the SA 2 UA disconnected ...

Page 57: ...s representative 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 changed to solid red during these Warning or Error states Go to Tools section Select the Error s a...

Page 58: ...well as technical resources on a variety of applications related to the VETSCAN SA analyzer Resource How to Contact Local Authorized Zoetis Distributors Find local Zoetis authorized Distributors on the Zoetis website www Zoetis com Technical Information Find technical information package inserts and manuals on the Reference Center on the Zoetis website www Zoetis com Technical Support For technica...

Page 59: ... also input a Specific Gravity of each sample for the medical record Specific Gravity 1 xxx 1 000 minimum 1 199 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 selection options All sample should initially be analyzed as native or undiluted p...

Page 60: ...ferentiate between the potential causes for urine color and urine turbidity Analysis Urine turbidity can be changed or increased for several reasons including the presence of crystals mucus lipids bacteria or casts in the urine 1 To avoid over dilution and underdiagnosis of pathology in urine sediment urine samples should not be diluted prior to initial analysis on the VETSCAN SA 3 Different level...

Page 61: ...vided to determine next appropriate steps Image provides clinical insight Image provides minimal to no clinical insight It is not recommended to perform a dilution prior to initial evaluation with the VETSCAN SA as this could result in missing pathology that is present 1 Bacteriuria and pyuria present in sample No dilution required Calcium oxalate dihydrate crystals present in sample No dilution r...

Page 62: ...linical direction Dilution Ratio Urine Volume Sterile 0 9 NaCl saline Volume 1 2 0 4 mL 0 4 mL 1 4 0 2 mL 0 6 mL 1 8 0 1 mL 0 7 mL When performing dilution Use only sterile 0 9 NaCl to dilute urine samples Invert tube gently 10 15 times immediately prior to running the sample NOTE Diluting a urine sample may alter the sample pH and osmolality which could lead to changes in cellular appearance or t...

Page 63: ...e 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 Zoetis 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 eryt...

Page 64: ...3 100 GLU Semi Quantitative 1 2 3 4 mg dL CON 0 50 100 250 500 1000 mmol L SI 0 2 8 5 5 14 28 55 PRO Semi Quantitative 1 2 3 mg dL CON 15 15 30 100 300 g L SI 0 15 0 15 0 3 1 3 SG no units 1 000 1 010 1 015 1 020 1 030 1 040 1 045 1 050 1 060 pH no units 5 0 5 5 6 0 6 5 7 0 7 5 8 0 8 5 9 0 BLD Semi Quantitative 1 2 3 Cell μL CON 0 10 25 80 200 Cell μL SI 0 10 25 80 200 ASC Semi Quantitative 1 2 3 ...

Page 65: ... ignored include nitrites leukocytes ascorbic acid calcium and urobilinogen 1 For improved precision urine specific gravity is best assessed with a refractometer and color is best assessed visually The primary use of CRE on the UA14 strip is for calculating the urine protein creatinine ratio and CRE should not be evaluated on its own 1 Sink CA and Weinstein NM Routine Urinalysis Chemical Analysis ...

Page 66: ...1550 7013 Rev C Zoetis Services LLC 333 Portage Street Kalamazoo MI 49007 USA www zoetis com Zoetis Belgium S A Rue Laid Burniat 1 1348 Louvain La Neuve Belgium ...