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

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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)