Zoetis vetscan SA User manual

SA
Sediment Analyzer
USER’S
MANUAL
v1.2 Software For Veterinary Use Only

VETSCAN SA USER’S MANUAL v1.2 SOFTWARE | 2
Abaxis, Inc., 3240 Whipple Road, Union City, CA 94597 | [phone] | 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

VETSCAN SA USER’S MANUAL v1.2 SOFTWARE | 3
Disclaimer
For Veterinary Use Only.
No part of this publication may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopy, recording, or any information storage or retrieval
system, without permission in writing from Zoetis.
Zoetis reserves the right to modify its products and services at any time. This user’s manual
is subject to change without notice. Although prepared to ensure accuracy, Zoetis assumes
no liability for errors, or for any damages resulting from application or use of this information.
No rights are granted for diagnostic uses. No rights are granted for use of the product for
commercial application of any kind, including but not limited to manufacturing, quality control,
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 the analyzer during this warranty period, Zoetis will repair or replace the
defective parts free of charge. The following defects, however, are specifically excluded:
1. Defects caused by improper operation.
2. Repair or modification done by anyone other than Zoetis or an authorized agent.
3. Use of fittings or other spare parts supplied by anyone other than Zoetis.
4. Damage caused by accident or misuse.
5. Damage caused by disaster.
6. Corrosion due to use of improper solvent or sample.
The device’s protection will be impaired if used in a manner not specified by the manufacturer.

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Declaration Of Conformity
Manufacturer:
Zoetis Inc.
10 Sylvan Way
Parsippany, NJ 07054
The Directives covered by this Declaration
EU Machinery Directive 2006/42/EC
EU RoHS2 Directive 2011/65/EU
The Products Covered by this Declaration
VETSCAN SA sediment analyzer
The Basis on which Conformity is being declared
The manufacturer hereby declares under his sole responsibility that the products identified
above comply with the essential health and safety requirements of the Machinery directive
2006/42/EC.
The manufacturer has applied the following standards:
EN ISO 13485:2016 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-Automatic Laboratory
Equipment for Analysis and Other Purposes
The technical documentation required to demonstrate that the products meet the requirements
of the Machinery directive 2006/42/EC can be made available to relevant authorities within a
reasonable period of time.
EIC/EN 61326-2-6
EN 55011, EN 61000-3-2, EN 61000-3-3
EN 61000-4-2, EN 61000-4-3, EN 61000-4-4, EN 61000-4-5, EN 61000-4-6, EN 61000-4-8,
EN 61000-4-11

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Table of Contents
Introduction .................................................................................................................................................................................................... 6
Intended Use ................................................................................................................................................................................................. 7
Result Classifications ........................................................................................................................................................................... 8
Result Warnings ..................................................................................................................................................................................... 9
System Overview ...................................................................................................................................................................................... 10
Safety ...............................................................................................................................................................................................................13
VETSCAN SA Menu ..................................................................................................................................................................................14
Running a Sample ......................................................................................................................................................................................16
Sample Collection ................................................................................................................................................................................16
Sample Handling ...................................................................................................................................................................................16
Dilution .......................................................................................................................................................................................................16
Running a Test ........................................................................................................................................................................................17
SA+UA Test ..............................................................................................................................................................................................18
SA Only Test .......................................................................................................................................................................................... 20
UA Only Test ...........................................................................................................................................................................................21
Urinalysis Results ......................................................................................................................................................................................23
SA Images Panel ..................................................................................................................................................................................24
SA Results Panel ..................................................................................................................................................................................25
UA Results Panel ..................................................................................................................................................................................26
Urinalysis Printout ...............................................................................................................................................................................27
Retest SA .......................................................................................................................................................................................................28
Database – Reviewing Previous Results ...................................................................................................................................... 30
Maintenance ..................................................................................................................................................................................................31
Maintenance Schedule ......................................................................................................................................................................32
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 G: Safety and Regulatory Compliance ....................................................................................................................51
Appendix H: Part Numbers .................................................................................................................................................................52
Appendix I: Troubleshooting ..............................................................................................................................................................53
Appendix J: Gross Examination, Specific Gravity, and Dilution Fields ...............................................................................59
Appendix K: Understanding Urine Dilutions on the VETSCAN SA ..............................................................................60
Appendix L: VETSCAN SA Suggested Normal Ranges ..........................................................................................................63
Appendix M: VETSCAN UA Results Bins ...................................................................................................................................... 64

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Introduction
The VETSCAN SA enables practitioners to perform urine microscopy by evaluating 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.

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Intended Use
The VETSCAN SA is intended for veterinary use only for testing of urine sediment in mammalian
urine samples, particularly dogs and cats. Urine samples collected from other species may be
run on the analyzer, but have not been validated. The VETSCAN SA will provide quantitative and
semi-quantitative analysis of the following sediment particles 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
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 chemistry testing, physical
evaluation (including urine specific gravity), and other clinical diagnostics to obtain a complete
evaluation of the disease process affecting the patient. It is best practice to review images
provided with every sample run.

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Result Classifications
The VETSCAN SA reports both quantitative and semi-quantitative results.
Quantitative Results
Parameter SA Display ≤ 5.0 Range Above Range Units
Red Blood Cells RBC NTR 5-500 >500 /µL
White Blood Cells WBC NTR 5-500 >500 /µL
Parameter SA Display ≤ 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 + ++ +++ ++++
Calcium Oxalate Crystals CaOx dihydrate NTR + ++ +++ ++++
NTR = None To Rare
Result Bin Definition
+Few
++ Moderate
+++ Many
++++ Numerous

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Result Warnings
The VETSCAN SA also displays warnings above the test results in a section titled SA Test
Results. It is best practice to review the images provided with every sample run.
The SA Test Results section will turn orange if “Review Images—Unclassified Elements Present,”
“Review Images—Bacteria Suspected,” “Review Images—Multiple Elements Suspected,” “TNTC—
Dilute and retest” and “Possible short sample” are indicated.
SA Test Results display text: Description Action
Completed Nothing abnormal or
questionable Review images
Review Images – Unclassified
Elements Present
SA detected abnormal levels of
undefined elements
Review images; review
on manual slide and/or
confirm with send-out
laboratory
Review Images—Bacteria
Suspected SA detected presence 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 bacteria
5. abnormal levels of undefined
sediment & detected presence
of bacteria
Review on manual slide
and/or confirm with send-
out laboratory
TNTC – Dilute and retest
Too numerous to count; too
many particles in image; sample
dilution may be required.
Review images provided
to determine if pathology
can be determined
without dilution. If this is
not possible, the sample
should be diluted to
Lowest dilution ratio and
rerun.
Possible short sample SA may not have received
enough sample to complete test
Retest and ensure sample
probe touches tube
bottom.
Not measured UA only test selected None

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System Overview
The VETSCAN SA Sediment Analyzer Final Assembly includes:
• VETSCAN SA Sediment Analyzer (PN 1550-1000)
• VETSCAN SA Tubing Kit (PN 1550-1001)
• VETSCAN SA Waste Bottle (PN 1550-1002)
• VETSCAN SA USA 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 1550-9001)
• VETSCAN SA Control Kit (PN 1550-9002)

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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
WASTESENSOR
1
2
1
2
1
2
3
3
RINSE A
RINSE B

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Ports
(1) Ethernet ports (2) USB ports (3) VGA monitor port
(4) Mouse port (5) Keyboard port
WASTESENSOR
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.

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Safety
The VETSCAN SA system is designed for maximum user safety and for indoor use only.
The plastic enclosures are made of thick injection-molded acrylic to create a leak-free test
environment. The safety metal cover surrounds the system to protect the user from exposure
to electrical current.
Before use, inspect the VETSCAN SA system for cracks and chips, which may allow the test
sample to leak from the tubes and cause a potential electrical hazard. Additionally, inspect all
electrical cables and plugs for loose connections, cracks, breaks or corrosion. Do not use any part
that is cracked, charred, or corroded. These parts may also cause a potential electrical hazard.
If leaking sample is detected, disconnect the power to the analyzer immediately.
Power to VETSCAN SA system is supplied by an external DC voltage power supply. All Zoetis’s
power supplies have met the safety requirements. Zoetis supplies the recommended power
cords for this unit. Only use Zoetis supplied power supplies specified 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 safety certification
- Create a potential safety hazard
Contact your local Zoetis representative before using a part that may be considered hazardous
or if leaking is detected.
When moving the SA analyzer, 2 people should handle any lifting.
Proper use of gloves is recommended when testing. OSHA requirements for personal protective
Equipment (PPE) are set forth in the code of Federal Regulations (CFR) at 29 CFR 1910.132
(General Requirements); 29 CFR 1910.138 (Hand protection); 29 CFR 1926.95 (Criteria for
standard personal protective equipment). Any gloves with impaired protective ability should be
discarded and replaced. Consider the toxicity of the chemicals and factors such as duration of
exposure, storage, and temperature when deciding to reuse chemically exposed gloves. Please
also consider local Occupational Safety and Health regulations.

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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.

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The Measure menu screen is divided into five different panels.
Measure Menu Screen
1. Left Side Panel: guides 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

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Running a Sample
Sample Collection
Urine samples may be collected by any of these methods for analysis on the SA.
1. Cystocentesis: Insert a small needle into the bladder through the skin and draw urine into
the syringe. The technique is ideal for collecting urine samples for bacterial culture.
2. Catheter: Place a urinary catheter within the urethra and advance it into the bladder.
Collect the sample using a sterile syringe. Sterile technique should be followed both for
the patient’s urinary tract health and integrity of bacterial culture, if needed.1
3. Free catch/voided (mid-stream): Using a sterile urine collection jar, collect a mid-stream
urine sample. Free catch samples are most at risk for contamination by the genital tract,
skin, and hair which can result in a false positive bacterial identification and culture.1
Urine collected from a litter box, floor or exam table will have additional sources of
contamination. Bacteria, hyphal structures, and foreign material if identified, should be
considered as such and another sample collected, especially if bacterial culture is needed.
It is recommended to acquire at least 1 mL of urine sample prior to running a test. The SA
requires approximately 650 µL (0.65 mL) of sample to run a SA test and additional sample
is required for application to UA strip, if also running a UA test.
Sample Handling
Do not centrifuge or stain urine samples before use on the VETSCAN SA and 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.
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 depending on the pathology that can
be identified in the images provided by the VETSCAN SA.2 When performing dilutions, use only
sterile 0.9% NaCl to dilute urine samples. Invert the tube gently 10-15 times immediately prior to
running the sample. The SA will automatically calculate results based on the dilution selected.
SPECIAL CASES: In SA Software v1.1 or higher, if a UA10 or UA14 strip is utilized and run with the
SA for the same patient, pH is factored into the crystal classification to more accurately identify
calcium oxalate crystals and struvites. If a patient with stones or severe crystalluria is currently
on a prescription diet that alters the urine pH to decrease crystal formation or dissolve a urinary
stone, update to the SA Software v1.1 crystal identification that factors in the urine pH should
be disabled for more accurate results. The pH in this case may cause crystals to be misclassified
due to the patient’s clinical status. To disable the pH aspect of the classification, the SA must
be run separately from the UA then combined later in the Database. See Database – Reviewing
Previous Results section for detailed information on this process.
1. Sink CA and Weinstein NM. Practical Veterinary Urinalysis. Ames, IA: John Wiley & Sons Inc. 2012 2. Dennis and DiBartola, Stephen,
Interpretation of Canine and Feline Urinalysis. Nestle Purina, Wilmington, De. 2004.

VETSCAN SA USER’S MANUAL v1.2 SOFTWARE | 17
Running a Test
The VETSCAN SA and UA analyzers can be connected together to produce a full urinalysis
report. The SA analyzer becomes the urinalysis workstation where all data entry will take place
and sample runs are initiated.
Follow on-screen instructions. Patient ID, Species and Test Type are minimum required selections
before the Run button is enabled. These required inputs are locked at the time the Run button
is clicked and may not be changed during and 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.
Analyzers used
Test Workflow (3) SA+UA test SA only test UA only test
Test Type (5) SA+UA10, SA+UA14 SA UA10, UA14
See Appendix I for details on Gross Examination, Specific Gravity, and Dilution fields.
If a SA+UA test is selected, always start the SA test first. Each of the three test workflows are
detailed below.

VETSCAN SA USER’S MANUAL v1.2 SOFTWARE | 18
SA+UA Test
SA Test
1. Enter Patient Information:
Enter Patient ID and select Species (Cat, Dog, Other, Control).
Enter Patient Name and Doctor Name if desired.
2. 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, if available, in format 1.xxx. It is recommended that
specific gravity is measured using a refractometer.
4. Enter any additional details in the comments section.
5. Select Test Type (2 options): SA+UA14, SA+UA10
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. 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 tip to allow 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.
UA Test
10. Confirm Strip Type, Species, and PID (Patient ID) on UA analyzer. Prepare to apply urine to UA
strip. If incorrect, the UA test can be canceled by pressing the UA Back button, and the overall test
will be changed to SA only.
11. Press Test (Test Tube icon) button to start test. Countdown
timer appears. Perform the next three steps before the
timer reaches 35.
1. Zoetis Internal VETSCAN SA Dilution Study – TI-04858

VETSCAN SA USER’S MANUAL v1.2 SOFTWARE | 19
12. Re-mix urine sample by gently inverting. Ensure a thoroughly mixed sample.
13. Immediately 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 dipped into urine
sample, completely wetting every pad. Remove the strip
after 2 seconds.
14. Blot either long edge of strip on absorbent paper to
remove excess urine. DO NOT blot the top surface
of the pads to avoid contamination. Work quickly
to blot excess urine. Delays in blotting may affect
results.
15. Place strip on the UA Strip Tray. The end of the strip
should align with the end of the trough in the Strip Tray,
approximately where the top cover of the UA analyzer
is indented. This step MUST be completed before the
countdown 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! 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 measuring, the SA screen is locked, and navigation to other screens is prohibited. Also,
both the SA status indicator light (top right of the SA Results Panel) and the UA status indicator
light (top right of the UA Results Panel) will display yellow during measurement process. Do not
disconnect UA from SA during testing process. If the UA becomes 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.
UA Test (continued)

VETSCAN SA USER’S MANUAL v1.2 SOFTWARE | 20
SA Only Test
1. Enter Patient Information:
Enter Patient ID and select Species (Cat, Dog, Other, Control).
Enter Patient Name and Doctor Name if desired.
2. 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, if applicable, in format 1.xxx. It is recommended that
specific gravity is measured using a refractometer.
4. Enter any additional details in the comments section.
5. 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 probe tip to allow 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.
1. Zoetis Internal VETSCAN SA Dilution Study – TI-04858