Idexx SediVue Dx Operator's Manual

SediVue Dx* Urine Sediment Analyzer

Operator’s Guide

Proprietary rights notice

Information in this document is subject to change without notice. Companies, names, and data used in examples are fictitious unless otherwise noted. No part of this document may be reproduced or transmitted in any form or by any means, electronic, mechanical, or otherwise, for any purpose, without the express written permission of IDEXX Laboratories. IDEXX Laboratories may have patents or pending patent applications, trademarks, copyrights, or other intellectual or industrial property rights covering this document or subject matter in this document. The furnishing of this document does not give a license to these property rights except as expressly provided in any written license agreement from IDEXX Laboratories.

*SediVue Dx, SediVue, IDEXX VetLab, SmartService, and VetConnect are trademarks or registered trademarks of IDEXX Laboratories, Inc. in the United States and/or other countries. All other product and company names and logos are trademarks of their respective holders.

IDEXX Laboratories, Inc. One IDEXX Drive Westbrook, Maine 04092 USA

IDEXX Europe B.V. P.O. Box 1334 NL-2130 EK Hoofddorp

Contents

Getting started ........................................................................................................................................5

Welcome! .....................................................................................................................................................5

Introduction ..................................................................................................................................................5

SediVue Dx results .......................................................................................................................................6

SediVue Dx images .....................................................................................................................................7

Compatible species .....................................................................................................................................8

SediVue Dx components .............................................................................................................................8

SediVue Dx supplies ....................................................................................................................................9

Pay per Run .................................................................................................................................................9

Analyzer status ............................................................................................................................................9

Including physical/chemical urinalysis results with your

SediVue Dx results ...............................................................................................................................10

Running a sample on the analyzer ......................................................................................................11

Installing/replacing the cartridge sleeve ....................................................................................................11

Preparing samples ....................................................................................................................................12

Analyzing a sample ...................................................................................................................................12

Diluting samples ........................................................................................................................................13

Understanding your results .................................................................................................................14

Dilutions .....................................................................................................................................................14

Out of focus ...............................................................................................................................................15

Bacteria ......................................................................................................................................................15

Crystals ......................................................................................................................................................18

Urine protein:creatinine (UPC) ratio ..........................................................................................................18

Accessing results .................................................................................................................................19

Viewing and printing test results ...............................................................................................................19

Reviewing and selecting images ...............................................................................................................19

Adding comments to results .....................................................................................................................20

Printing images on the patient report ........................................................................................................20

Quality control ......................................................................................................................................22

Overview ....................................................................................................................................................22

Running quality control ..............................................................................................................................22

Maintenance .........................................................................................................................................23

Upgrading the software .............................................................................................................................23

Emptying the waste bin (as needed) .........................................................................................................23

Rebooting the analyzer (weekly) ...............................................................................................................23

Cleaning the fan filter (weekly)...................................................................................................................23

Cleaning the analyzer (monthly or as needed) .........................................................................................24

Frequently asked questions .................................................................................................................27

Cartridge FAQs ..........................................................................................................................................27

Image FAQs ...............................................................................................................................................28

Miscellaneous troubleshooting FAQs ........................................................................................................28

QC FAQs ....................................................................................................................................................29

Pay per Run and auto replenishment FAQs ..............................................................................................29

Appendices ...........................................................................................................................................30

Preparing the installation site ....................................................................................................................30

Installing the SediVue Dx analyzer .............................................................................................................30

Technical specifications .............................................................................................................................31

Safety precautions .....................................................................................................................................31

International symbol descriptions ..............................................................................................................33

Other symbols ...........................................................................................................................................34

IDEXX technical support contact information ............................................................................................35

Getting started

Welcome!

Congratulations on your recent purchase of the SediVue Dx* Urine Sediment Analyzer. The SediVue Dx will seamlessly integrate with your IDEXX VetLab* ecosystem along with your other IDEXX in-house analyzers, IDEXX VetLab* Station, VetConnect* PLUS, all IDEXX practice management software, as well as multiple other leading practice management software.

The SediVue Dx analyzer uses propriety neural network algorithms and machine-learning capabilities to identify and classify elements within urine sediment. Using SmartService* Solutions, the SediVue Dx leverages the collective learnings of millions of patient images to guide confident medical decisions to bring you unparalleled accuracy and reliability. Only with IDEXX can one SediVue Dx customer benefit from the collective learning of all. Leveraging the images and neural network algorithms is unique to IDEXX and is critical in advancing machine-learning capabilities so we can identify the rarest of cases, enhance our offering, and expand our test menu.

Introduction

The SediVue Dx Urine Sediment Analyzer is a semiautomated urine microscopy system that performs a urine sediment analysis from only 165 μL (4–5 drops) of fresh, uncentrifuged urine in approximately 3 minutes. It uses a gentle, low-speed, on-board centrifuge for 30 seconds to preserve the integrity of the sediment and takes 70 high resolution digital images (equivalent to 45 High Power Fields (HPF) of View) for every sample run. The SediVue Dx then leverages proprietary cutting-edge convolutional neural network technology and machine learning to identify, classify, and prioritize clinically significant formed elements within the sediment to increase the reliability, speed, and accuracy of detecting renal and urinary tract abnormalities. The SediVue Dx provides reproducible and sensitive analysis of the following sediment-forming particles in native urine samples:

Blood cells Epithelial cells Bacteria Casts Crystals

• Red blood cells (RBCs)

• White blood cells ( WBCs)

• Squamous

• Nonsquamous (e.g., transitional cells, renal tubular cells)

• Rods

• Cocci

• Hyaline

• Nonhyaline (e.g., cellular casts, granular casts)

• Struvite

• Calcium oxalate dihydrate

• Unclassified (all other crystals)

SediVue Dx results

The SediVue Dx analyzer provides results in the following concentration levels:

Getting Started

Element

type

Blood

Cells

Element

type

Bacteria

Epithelial

Cells

Parameter Quantitative results

WBC

RBC

Parameter Semiquantitative results

Rods

Cocci

Squamous

Nonsquamous

Hyaline

Casts

Nonhyaline

(e.g., granular,

waxy)

Unclassified

(all other

crystals)

Crystals

Oxalate

Dihydrate

Struvites

†

Image tags not available.

<1/HPF Quantitative numerical result/HPF >50/HPF

None to

†

rare

None to

†

rare

None to

†

rare

None to

†

rare

Suspect presence

1–2/HPF 3–5/HPF 6–10/HPF >10/HPF

Suspect presence

1–5/HPF 6–20/HPF 21–50/HPF >50/HPFCalcium

†

Present

>1/LPF

†

The SediVue Dx analyzer is for veterinary use only.

None to Rare—For most sediment, this indicates the neural network detected fewer than 1 element/HPF (or LPF for casts). This generally means that the number found for a particular formed element is below the reporting threshold and is typically not considered clinically significant as published in the majority of veterinary textbooks and academic journals. Since the SediVue Dx is analyzing 45 HPF, which is up to four times more material than the typical 10 HPF reviewed during manual microscopy, there is a potential for finding a single (or very few) element(s) that would have normally been reported as “none seen” by a veterinary or reference laboratory technician with the manual method. For bacteria, none to rare indicates the neural network characterized the sample as unlikely to contain bacteria.

Suspect Presence—The SediVue Dx recognizes some features or attributes of a particular element (cocci, rods, casts, etc.); however, there may not be not enough features present to provide a “present” message. Image review is strongly recommended for confirmation.

Present—There is a high confidence in the presence of the particular element reported (cocci, rods).

SediVue Dx images

The SediVue Dx Urine Sediment Analyzer takes 70 high-resolution digital images for every patient run. These images are equivalent to 45 high-power fields of view using a 40x objective. Using a proprietary neural network algorithm, each of the 70 images is scanned to identify, classify, and count the formed elements. Each image is given a score based on the absence or presence of formed elements and the clinical significance for each found. The images are then sorted, with the highest scoring images displayed first and lowest scoring images displayed last. The top three images are automatically retained by the SediVue Dx and transmitted to VetConnect* PLUS.

Image review

Similar to manual microscopy, the sample images should be reviewed with every sample run in order to arrive at consensus of the results. This process can take as little as a few seconds. The value in reviewing the images is to validate the numerical data provided and potentially supplement the SediVue Dx analysis, if needed.

Image tags

Image tags are abbreviated labels for the reported parameters that appear on the formed elements found in the sample. Image tags may not be available:

• If the image is out of focus or flagged for review.

Getting Started

• If the sample is from an unvalidated species or fluid.

• When the results are None to Rare or Suspect Presence (for casts).

• For bacteria results.

Image tags can be toggled on and off.

Convolutional neural network

SediVue Dx’s convolutional neural network is a proprietary pattern-recognition algorithm that works similar to facial recognition software. The Neural Network leverages a veterinary-specific image library that is used to train and grow the algorithm over time. It is what drives the identification, classification, and count of each of the formed elements.

Bacteria; rods with white and red

blood cells

Bacteria; cocci with white blood

cells

Large struvite crystals

Ammonium biurate (thorn apple)

crystals

Hyaline cast Bilirubin crystal with

RBCs and WBCs

Compatible species

The SediVue Dx analyzer has been validated on canine and feline urine samples.

Note: Urine from other species or other fluid types may be run on the analyzer; however, only images will be included in the report.

SediVue Dx components

Front of the analyzer

Getting Started

Status light

Start button

Inside of the analyzer

Sleeve lock

Optical stage

Pipetting window

Power button Door access

Waste bin

Centrifuge shield

Cartridge holder Drip tray

Optical window

Track

Back of the analyzer

Fan filter

Ethernet port

Power port

SediVue Dx supplies

IDEXX proactively monitors your usage of SediVue Dx supplies via your SmartService connection. You can call IDEXX Technical Support to place an order or order them online.†

Supplies available:

• Cartridges

• Pipette tips

• QC fluid

†

• Syringe tips

• Cleaning supplies (alcohol prep pads and optical tissues)

†

Note: In North America, certain supplies will be sent automatically when your inventory is low.

Pay per Run

Pay per Run for the SediVue Dx Urine Sediment Analyzer is an innovative test billing and inventory management system that increases cash flow by allowing you to bill your clients in advance of paying for the sample analysis. Pay per Run works in conjunction with your SmartService* Solutions connection to monitor patient runs on your SediVue Dx analyzer and bill for those runs on a monthly basis:

Runs are invoiced on a monthly basis according to your localized standard payment terms.

• The first patient run that provides semiquantitative results and/or images in a 24-hour period

Getting Started

‡

• The first quality control (QC) run for each level of QC in a 24-hour period

‡

For specific details on what runs are invoiced for your region, call IDEXX Technical Support.

Note: If your SmartService Solutions is accidentally disconnected, the data for any runs that were completed (or supplies used) during the outage will be corrected once the connection is reestablished.

Analyzer status

The light on the front of the SediVue Dx analyzer indicates the analyzer’s status.

Note: You can also view the analyzer status by viewing its icon on the IDEXX VetLab* Station Home screen.

When light displays this color...

Steady green Ready to process a sample.

Steady yellow Processing a sample.

Flashing yellow Waiting for you to inject sample in a cartridge in the pipetting

Flashing red Experiencing an issue or requires maintenance.

‡

The analyzer is...

window.

Including physical/chemical urinalysis results with your SediVue Dx results

The IDEXX VetLab Station includes a UA icon on the Select Instruments screen that allows you to enter physical and chemical urinalysis results so that they can be included with your SediVue Dx results for a comprehensive urinalysis.

By default, this icon displays in the patient’s job status area when the SediVue Dx icon is selected. If you would like to modify the setting, follow these steps:

1. Tap the SediVue Dx icon on the IDEXX VetLab Station Home screen.

2. Tap Settings.

3. If you do not want to automatically include the UA icon with the SediVue Dx icon in the patient’s job status area, clear the Automatically add UA physical record icon to SediVue Dx runs check box.

If you want to automatically include the UA icon with the SediVue Dx icon in the patient’s job status area, select the Automatically add UA physical record icon to SediVue Dx runs check box.

Getting Started

Running a sample on the analyzer

Installing/replacing the cartridge sleeve

You’ll receive a message on the IDEXX VetLab* Station when the cartridge sleeve is almost empty. You can choose to be reminded again after the next run or when the cartridge sleeve is empty.

1. Tap the SediVue Dx icon on the IDEXX VetLab Station Home screen. OR Tap Replace Cartridges in the alert message.

2. Scan or enter the case-sensitive bar code located on the plastic wrapping on the new cartridge sleeve.

Note: If the bar code is still not accepted, discard the sleeve and try a new cartridge sleeve. If the problem continues, or you need to adjust inventory, call IDEXX Technical Support.

3. Tap Continue.

Note: If the Continue button is not enabled, not all of the bar code characters have been entered.

4. Open the analyzer door.

5. Pinch the sleeve lock to release it and then pull the old cartridge sleeve up to remove it.

6. With the product labeling on the new sleeve facing toward you, push down on the sleeve until it locks into place and then remove the tape from the bottom of the sleeve.

IMPORTANT: Do not remove the tape from the sleeve until it is locked into place.

7. Close the analyzer door.

8. Tap OK to confirm that the loading process is complete.

Note: When handling cartridges, remember:

• Never touch unused cartridges—contamination may interfere with microscopic evaluation.

• Never refill a sleeve with dropped cartridges. Discard the sleeve and install a new cartridge sleeve. Call IDEXX Technical Support to adjust your inventory quantity.

• Never manually remove cartridges from the cartridge sleeve.

+ 25 hidden pages

Idexx SediVue Dx Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual