scil Element i+ Manual de usuario
User Manual
Immunodiagnostic Analyzer
Element i+
For Veterinary In-Vitro Diagnostic Use Only
Vers.:20220531ENG 2
Introduction
Thank you for purchasing the Element i+™ Immunodiagnostic Analyzer.
The Element i+ Immunodiagnostic Analyzer is a veterinary diagnostic device used to perform
immunological analyses using proprietary Element i+™ Cartridges.
This product is for veterinary use only.
Before using this equipment, please read this manual carefully and follow the precautions for
correct operation.
The Element i+ Immunodiagnostic Analyzer is manufactured for Heska Corporation by MBio
Diagnostics, Inc. (MBio), Boulder, Colorado, USA.
•No part or all of this manual may be reproduced in any form without prior permission.
•The information contained in this manual may be subject to change without prior notice.
•Heska/MBio shall not be liable for malfunctions and damage resulting from installation,
relocation, remodeling, maintenance, and repair done by other than dealers specified by
Heska.
•Heska/MBio shall not be liable for malfunctions and damage of Heska products due to
the use of products of other manufacturers not supplied by Heska.
•Heska/MBio shall not be liable for malfunctions and damage resulting from negligence of
precautions and operating methods contained in this manual.
•Heska/MBio shall not be liable for malfunctions and damage resulting from use under
environmental conditions outside the range of conditions required for proper use of this
product, such as power supply, installation environment, etc. contained in this manual.
•Heska/MBio shall not be liable for malfunctions and damage resulting from natural
disasters such as fires, earthquakes, floods, lightening, etc.
Vers.:20220531ENG 3
Table of Content
Introduction........................................................................................................................ 2
1Safe Usage and Handling Precautions..................................................................... 4
1.1 Precautions before Operating this Equipment........................................................... 4
1.2 Biohazards and Waste ............................................................................................. 4
1.3 Electrical Hazards..................................................................................................... 5
1.4 Declaration of Conformity / Electromagnetic Compatibility (EMC)............................. 5
1.5 Laser Warning.......................................................................................................... 6
1.6 Other Safety Warnings............................................................................................. 6
1.7 Table of Symbols...................................................................................................... 6
2Overview.................................................................................................................. 7
2.1 Components and Labeling........................................................................................ 7
2.2. Specifications.......................................................................................................... 8
2.3. Calibration............................................................................................................... 8
3Transport, Unpacking, and Installation...................................................................... 9
3.1 Packaging ................................................................................................................ 9
3.2 Unpacking ................................................................................................................ 9
3.3
Parts List
................................................................................................................... 9
4Analyzer Operation..................................................................................................10
4.1 Turning the Analyzer Onand Off ..............................................................................10
4.2 MainScreensandControlsontheUserInterface......................................................10
4.3 Adjust Units and Reference Ranges........................................................................11
4.4 ImportaCartridgeType/CalibrationInformation........................................................12
4.5 CartridgeOverview..................................................................................................13
4.6 Running aSample ...................................................................................................13
4.7 Running aTest.........................................................................................................14
4.8 Review Test Results................................................................................................16
5Maintenance and Cleaning......................................................................................17
5.1 Cleaning Outside Surfaces......................................................................................17
5.2 Cleanable Air Filter..................................................................................................17
6Troubleshooting.......................................................................................................18
6.1. Error Handling........................................................................................................18
6.2. Table of Common Error Messages.........................................................................18
Vers.:20220531ENG 4
1 Safe Usage and Handling Precautions
This section contains safety precautions which must be followed for safe operation of the
Element i+ Immunodiagnostic Analyzer (also called Element i+ Analyzer in this manual).
The Element i+ Analyzer is used in conjunction with Element i+ Cartridges. Please refer to
instructions included in this manual and contained in the Quick Steps Guide for test-specific
information.
1.1 Precautions before Operating this Equipment
CAUTION
Before using this equipment, read this Product Manual carefully to ensure correct operation
of the equipment.
CAUTION
Whenever operating this equipment, observe the precautions described in this manual.
Failure to do so may result in injuries, cause property damage, or produce incorrect results.
CAUTION
The Element i+ Analyzer is for veterinary use only. The intended use is to quantify biological
markers in animal serum or plasma samples using Element i+ Cartridges. Do not use the
equipment for other purposes. Please refer to instructions included in this manual and
contained in the Quick Steps Guide.
CAUTION
This equipment is to be operated by personnel appropriately trained for its intended use and
correct operation.
1.2 Biohazards and Waste
Wear appropriate personal protective equipment for the sample type being tested when
using the Element i+ Analyzer.
Used cartridges, tips, and contaminated swabs or cloths used for cleaning equipment are
potentially infectious waste and disposal must follow applicable local, state, or federal
regulations.
When discarding the equipment that may be contaminated with sample, disposal must follow
applicable local, state, or federal regulations.
When handling samples and cleaning the equipment, always follow biohazard procedures
(e.g., wear gloves, lab coat, and eye protection), referring to the sample handling rules of
your facility.
Vers.:20220531ENG 5
1.3 Electrical Hazards
The power supply voltage applied to the equipment is AC100–240 V–1.5 A, 47–63 Hz.
The Element i+ Analyzer is only to be supplied power from the power
supply included in the package. To avoid electrical shock, observe the
following precautions:
•Avoid installation sites where water or other liquids may splash on the equipment.
•Make sure that the equipment is properly grounded to a protective earth lead for
indoor wiring.
•Make sure that all cables have been properly connected.
Plug the power cable into an outlet with a grounding receptacle.
When plugging the cable in or removing it from an outlet, be sure to hold onto the
plug, not just the cable, to prevent damage to the cable.
The equipment is not designed to be user serviceable. Do not remove covers or
other parts to avoid electrical shock or injury from moving parts.
1.4 Declaration of Conformity / Electromagnetic Compatibility
(EMC)
The Element i+ Immunodiagnostic Analyzer complies with the Essential Requirements of the
Low Voltage Directive 2014/35/ EU and with EMC Directive 2014/30/EU. The Analyzer was
tested according to EN 61010–1, UL 61010–1, and to EN 60825–1. The Element i+ Analyzer
complies with Part 15 of FCC regulations and FDA regulations 21 CFR 1040.10 and
1040.11, except for deviations pursuant to Laser Notice No. 50.
NOTE: This equipment 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 the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be required to correct
the interference at his/her own expense.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
FCC RF Radiation Exposure Statement: This equipment complies with FCC radiation
exposure limits set forth for an uncontrolled environment. End users must follow the specific
operating instructions for satisfying RF exposure limits. This transmitter must not be co-
located or operating with any other antenna or transmitter.
Vers.:20220531ENG 6
1.5 Laser Warning
The equipment includes an embedded laser. The equipment complies with FDA
performance standards for laser products except for deviations pursuant to Laser Notice No.
50, dated June 24, 2007.
The Element i+ Analyzer is considered a Class 1 laser product per IEC 60825–1: 2007.
Do not open the Element i+ Analyzer. The Element i+ Analyzer has no user serviceable
parts. Any unauthorized opening of the instrument can cause potential hazards, can expose
hazardous laser radiation, and will invalidate warranty claims.
The Element i+ Analyzer is a Class 1 laser device that has the following protective
measures: a light-tight enclosure and a safety interlock which prevents the internal laser
source from emitting should the cartridge slot door be opened when a cartridge is not
present.
If the enclosure is damaged, immediately stop using the analyzer to prevent possible
exposure to hazardous laser radiation.
CAUTION
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.
1.6 Other Safety Warnings
EXPLOSIVE HAZARD: Do not use flammable and explosive gas around the equipment.
DonotplacefingersintotheElementi+ Analyzercartridgeopening.
Cartridgesaresingleuseonly.Donotreusecartridges.Usedcartridgesshouldbehandled
aswasteanddisposed of according toall local laws andregulations for disposal of waste.
OnlyinsertcartridgessuppliedbyHeskaCorporation.Donotinsertdamagedcartridges
intotheanalyzer.
1.7 Table of Symbols
FCC mark
Recycle
Caution, consult accompanying instructions for safety related information
Consult instructions for proper use
DC electrical power rating
Biological risks
Serial number
Catalog number
Vers.:20220531ENG 7
2 Overview
2.1 Components and Labeling
Front
Analyzer label found
on the bottom of analyzer
Back
Touch screen
Status light
Cartridge
port/door
Carrying
handle
Air filter cover
and filter
Power
button
USB
A2.0
ports
Ethernet
port
Power
cord jack
Vers.:20220531ENG 8
2.2. Specifications
Detection System
Fluorescence Immunoassay
Cartridge
Element i+ compatible
Procedure time
Specific to test cartridge
Instrument electrical power rating
+15 DC/4.65 A max
Wall Power
100–240 V~ —1.5Amax, 47–63 Hz,
Overvoltage Category II
Laser classification
Laser Class 1 (per IEC 60825–1)
Operating temperature
59–86°F (15–30°C) indoors
Operating relative humidity
25–65%, non-condensing
Storage temperature
32–113°F (0 –45°C)
Storage humidity
5–95%, non-condensing
Physical dimensions
6.5 in (W) x 8.75 in (H) x 9 in (L)
165 mm (W) x 222 mm (H) x 229 mm (L)
Weight
5.51 lbs (2.5 kg)
Pollution Degree
2 max
Altitude
Up to 2000 meters
2.3. Calibration
The Element i+ Analyzer is factory calibrated and does not require any further calibration or
verification operations.
Vers.:20220531ENG 9
3 Transport, Unpacking, and Installation
3.1 Packaging
The Element i+ Analyzer ships in a custom-designed box. Transportation of the analyzer
must only be in this protective box.
3.2 Unpacking
•Unpack the Element i+ Analyzer and place on a level, stable surface. Inspect for any
obvious signs of damage. Report any damage immediately.
•Remove protective film from touchscreen if present.
•Before using, allow the analyzer to equilibrate to the surrounding temperature for at least
30 minutes.
3.3
Parts List
The following items are supplied with your Element i+ Analyzer:
•Element i+Analyzer
•Power supply andcord
•Fixed-volume (100 µL)pipettes
Vers.:20220531ENG 10
4 Analyzer Operation
4.1 Turning the Analyzer On and Off
The power toggle button is located on the lower back side of the analyzer. Press and release
the button one time. The indicator light on the front of the analyzer will turn on and go into
“breathing” mode during the boot-up sequence. When initially powered, the analyzer will run
through a series of self-diagnostic checks. When boot-up is complete, the indicator light will
glow steady and the login screen will appear.
The analyzer should be powered down using . If a hard re-start is required, hold the power
button on the back of the analyzer in for 7 seconds.
4.2 Main Screens and Controls on the User Interface
Power
on/off
Checkboxisenabledon all
screenswhenrequired
data
entryiscomplete
Keyboard appears when a
dataentryfieldisselected
Tabla de contenidos
Otros manuales de Equipo de laboratorio de scil
Manuales populares de Equipo de laboratorio de otras marcas
Agilent Technologies
Agilent Technologies 5800 ICP-OES Manual de usuario
Endress+Hauser
Endress+Hauser Cleanfit CPA875 Manual de usuario
NI
NI PXI-5422 Manual
Collomix
Collomix Aqix Manual de usuario
SPEX SamplePrep
SPEX SamplePrep 6875 Freezer/Mill Series Manual de usuario
Ocean Insight
Ocean Insight FLAME-NIR+ Manual de usuario
