Scil Element AIM Manuel utilisateur

User Manual

Element AIM

Automated Artificial Intelligence Microscopy

For veterinary use

Manual Introduction

This manual contains the following sections.

Preface: General introductory information and explanations of:

•Using this manual

•Contents overview

•Definitions and abbreviations

•Symbols

Safety: Explains the safety labels and precautions.

•Intended use

•User profile

•Application limits

•Information on product liability

•Warnings for intended use

•Safety instructions on the device

•Product description

•Product overview

•Delivery package and contents

•Features

•Analyzer identification

Installation: How to connect power and USB cables and how to accomplish the basic set-up.

Operation: Contains instructions for operating the analyzer.

Maintenance and Care: Explains how to perform basic care activities and regular maintenance tasks

such as opticscleaning. It also contains general advice for storage and shipping.

Troubleshooting: How to troubleshoot error messages that appear on the display, and how to gather

device informationbefore you call service.

Transport, Storage and Disposal: Explains how to transport the analyzer to its intended location, as

well as storage anddisposal guidelines.

Technical Specifications: Lists the technical data for the device described in this manual.Index: Lists

keywords in alphabetical order, with pointers to pages where they occur.

 

Table of Contents 
 
INTRODUCTION 
 
SECTION 1: SAFE USAGE AND HANDLING PRECAUTIONS 
1 Using This Manual ...........................................................................................................................................................1 
2 Definitions, Acronyms and Abbreviations........................................................................................................................1 
3 Symbols ...........................................................................................................................................................................1 
4 SafetyWarnings...............................................................................................................................................................1 
5 Product Liability Information ............................................................................................................................................1 
6 Warnings..........................................................................................................................................................................2 
7 Safety Instructions on the Analyzer.................................................................................................................................3 
8 Declaration of Conformity ................................................................................................................................................3 
9 Disposal ...........................................................................................................................................................................4 
SECTION 2: ELEMENT AIM ANALYZER OVERVIEW 
1 Product Overview.............................................................................................................................................................5 
1.1 Analyzer Identification............................................................................................................................................5 
2 Technical Specifications ..................................................................................................................................................6 
SECTION 3: TRANSPORT, UNPACKING, PACKING AND INSTALLATION 
1 Package Contents............................................................................................................................................................7 
2 Installation Location Requirement ...................................................................................................................................7 
3 Electrical Requirements...................................................................................................................................................8 
4 Moving the Analyzer ........................................................................................................................................................8 
5 Unpacking........................................................................................................................................................................8 
6 Removing Shipping Locks ...............................................................................................................................................8 
7 Connections and Operating Controls ..............................................................................................................................9 
7.1 Computer and Analyzer Connections....................................................................................................................9 
7.2 Mains Connection..................................................................................................................................................9 
8 Repacking for Shipment or Storage ..............................................................................................................................10 
SECTION 4: ANALYZER OPERATION 
1 Materials.........................................................................................................................................................................13 
2 Cartridge Fill Procedure.................................................................................................................................................13 
2.1 Equipment............................................................................................................................................................13 
2.2 Preparation Procedure for Urine Samples ..........................................................................................................13 

4.2.3 Cartridge Filling Procedure for Fecal Samples....................................................................................................15

4.3 Running a Test...............................................................................................................................................................16

4.3.1 Running a Urine Sediment Analysis....................................................................................................................16

4.3.2 Running a Fecal Sample .....................................................................................................................................18

4.4 Confirming and Reviewing Results................................................................................................................................20

4.5 Settings ..........................................................................................................................................................................22

4.5.1 General Settings..................................................................................................................................................22

4.5.2 Administrator Settings..........................................................................................................................................22

SECTION 5: MAINTENANCE AND CLEANING

5.1 Cleaning Outside Surfaces............................................................................................................................................24

5.2 Cleaning Optics..............................................................................................................................................................24

5.2.1 Equipment............................................................................................................................................................24

5.2.2 Cleaning Procedure for Optics ............................................................................................................................24

SECTION 6: TROUBLESHOOTING

6.1 Troubleshooting and Error Handling..............................................................................................................................27

Section 1: Safe Usage and Handling Precautions

a) 1.1 Using This Manual

Before starting to use the Element AIM™ Automated AI Microscopy Analyzer (Element AIM) read

through these instructions for use carefully and follow the instructions. Failure to follow the

instructions and safety information in these instructions for use will result in voiding of the

manufacturer warranty.

b) Definitions, Acronyms and Abbreviations

Acronyms

IFU Instruction for Use RPM Revolutions Per Minute

RCF Relative Centrifugal Force: g-force in m/s2

c) Symbols

CAUTION or WARNING

Electric Shock

Biological Hazard

Important Information

Pinch Point: Risk of Entanglement

Refer to Instruction Manual

d) Safety Warnings

Not following these safety instructions can lead to hazardous situations that, if not avoided, could

result in death or serious injury. Please observe all safety instructions.

Intended Use

The Element AIM is used for analysis of veterinary species’ urine and fecal samples in specifically

designed and approvedcartridges.

The analyzer is exclusively intended for use indoors. All country-specific safety requirements for

operating electricalequipment in the laboratory must be observed.

The analyzer and accessories may only be operated by trained personal.

Before using the analyzer, carefully read this instruction manual in full to familiarize yourself with

safe use and operation. The safety of this analyzer is not guaranteed beyond the service life of

the instrument (estimated 7 years from installation).

e) Product Liability Information

In the following situations, the protective systems and design of the analyzer might be affected.

Liability for any resulting damage or personal injury is transferred to the owner:

•The analyzer is not used in accordance with the Product Manual.

•The analyzer is used outside intended use or intended operator.

•The analyzer is used with accessories or consumables that are not supplied or recommended by

Scil animal care.

•The analyzer is repaired or maintained by persons not authorized by Scil animal care.

•Any unauthorized changes are made to the analyzer.

WARNING. This analyzer contains a centrifuge.

Keep a safety zone of minimum 30 cm around the analyzer. Refer to figure below. Persons and hazardous

substances

mustbekeptoutofthissafetyzonewhileanalyzeisinuse.

Do not test substances or materials other than those indicated in Section 1.4 –Intended Use.

Ensure only approved cartridges are used and filled as per instructions provided in section.

Use of the instrument with flammable, explosive or materials which could react chemically as to cause

a hazard

isprohibited.

f) Safety Instructions on the Analyzer

Indicates the need for the user to consult the instructions before use.

Indicates the need for the user to consult the instructions for use for important cautionary

information such as,

warningsandprecautions.

Indicating risk ofentanglementaround cartridge loading doorandport.

g) Declaration of Conformity

EMC

2014/30/EU EMC Directive EN61326-1: 2013

CFR47 FCC Sub-Chapter A Part 15B

This product has been tested and found to comply with the limits for a Class A digital

device pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable

protection against harmful interference when theequipment is operated in a commercial

environment.

Class A products are intended for use in non-residential/non-domestic environments. Class A

products may also be utilizedin residential/domestic environments, but in these environments the

equipment may cause interference with radio communications services which may require the

user to take adequate corrective measures. If this equipment does cause interference, the user is

encouraged to try to correct the interference by one or more of the following measures:

1. Re-orient the receiving antenna,

2. Relocate the analyzer with respect to the receiver,

3. Move the analyzer away from the receiver,

4. Plug the analyzer into a different outlet so that the analyzer and the receiver are on different

branch circuits.

Scil has reviewed their analyzer product for compliance with REACH - Registration,

Evaluation, Authorisation and Restriction of Chemicals (Regulation no. 1907 /2006 of the

European Parliament and Council) and the presence of the two hundred and eleven (211)

SVHC substances in the EU SVHC Candidate list as of 20th January 2021. The following

assessments are being made:

No SVHC's exceeding 0.1% w/w were present in the product, except as noted below. This

determination is based on engineering evaluation and supplier declarations and is correct to the

best of Scil´s knowledge.

NOTE:

1. Part Numbers A001476 and A001654 from Nikon contain:a. Lead [CAS 7439-92-1]

2. Part Number A001902 from FUR contain: a. Lead [CAS 7439-92-1]

b. BPA [CAS 80-05-7]

3. Part Number A005000 from DOW contains

a. Octamethyl Cyclotetrasiloxane [CAS 556-67-2]

4. Part Number A010247 from Mean Well contain: a. Lead [CAS 7439-92-1]

5. Part Number A007127-000 from Venture contain: a. Lead [CAS 7439-92-1]

b. Diboron trioxide [1303-86-2]

c. Lead monoxide [1317-36-8]

6. Part Number A007110-110 from Tornik contain: a. Lead [CAS 7439-92-1]

7. Part Number A007128-000 from Venture contain: a. Lead [CAS 7439-92-1]

h) Disposal

Cartridges are single use only. Do not reuse cartridges. Used cartridges should be

handled as biohazardous waste and disposed of according to all local laws and

regulations for disposal of biohazardous waste.

Element AIM bears the WEEE symbol to alert customers in the EU that this instrument

should not be disposed of in a landfill or with municipal or household waste. Please contact

Scil or your local dealer for further information regarding proper procedures for discarding

electrical and electronic equipment.

Section 2: Element AIM Analyzer Overview

2.1Product Overview

The Element AIM brings the convenience of automation and the learning capabilities of artificial

intelligence to urine sediment and fecal flotation analysis for veterinary patients. Leveraging a

unique and proprietary cartridge design, custom onboard centrifuge, state-of-the-art nano

positioning precision motor system, premium quality optical components, and high-powered

computational analytics, the Element AIM dynamically captures microscopic images which are

then categorized using artificial intelligence to identify specific objects of interest.

2.1.1. Analyzer Identification

Analyzer identification label can be found on the rear of the analyzer.

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