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Summary of Contents for scil Element i+
- Page 1 User Manual Immunodiagnostic Analyzer Element i+ For Veterinary In-Vitro Diagnostic Use Only...
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Page 2: Introduction
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. -
Page 3: Table Of Contents
Table of Content Introduction ........................2 Safe Usage and Handling Precautions ..............4 Precautions before Operating this Equipment ............4 Biohazards and Waste ..................... 4 Electrical Hazards..................... 5 Declaration of Conformity / Electromagnetic Compatibility (EMC) ......5 Laser Warning ......................6 Other Safety Warnings ..................... -
Page 4: Safe Usage And Handling Precautions
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. -
Page 5: Electrical Hazards
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: •... -
Page 6: Laser Warning
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. -
Page 7: Overview
2 Overview Components and Labeling Front Touch screen Cartridge Status light port/door Analyzer label found on the bottom of analyzer Back Carrying handle Air filter cover and filter Power button Ethernet Power A2.0 port cord jack ports Vers.:20220531ENG... -
Page 8: Specifications
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 100–240 V~ —1.5A Wall Power , 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... -
Page 9: Transport, Unpacking, And Installation
3 Transport, Unpacking, and Installation Packaging The Element i+ Analyzer ships in a custom-designed box. Transportation of the analyzer must only be in this protective box. Unpacking • Unpack the Element i+ Analyzer and place on a level, stable surface. Inspect for any obvious signs of damage. -
Page 10: Analyzer Operation
Analyzer Operation 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”... -
Page 11: Adjust Units And Reference Ranges
ON/OFF Button Settings menu Use a Worklist to run a sample Manually input information to run sample Review previously run samples Back button Home button Adjust Units and Reference Ranges • If you want to set the units, you must first go to the settings. Then go to the Administrator and there you will find the Units button. -
Page 12: Import A Cartridge Type/Calibration Information
Import a Cartridge Type/Calibration Information Each lot of Element i+ Cartridges is factory calibrated and has a unique, lot-specific calibration file that must be loaded into the analyzer software. Lot-specific calibration data are contained on an Figure 1 electronic Cartridge Definition File (CDF) written to a USB flash drive supplied with each cartridge box. -
Page 13: Cartridge Overview
Cartridge Overview The Element i+ Analyzer is designed to run exclusively with test-specific Element i+ Cartridges. Each production lot of cartridges is factory calibrated. Lot-specific calibration data are contained on an electronic Cartridge Definition File (CDF) written to a USB flash drive supplied with each cartridge box. -
Page 14: Running A Test
Running a Test 1. Obtain a serum or lithium heparinized plasma sample. 2. On the main screen, touch Worklist or Manual Test. Figure 3 3. In Worklist Mode, confirm that all fields have correct information and then touch to proceed. In Manual Mode, enter sample information in the required fields. - Page 15 Affix a tip to the 100 µL fixed volume mini-pipette. Aspirate 100 µL of sample, insert the pipette tip into the inlet port hole, and dispense the full sample amount into the hole. Figure 8 Figure 8 ✓ 8. Touch on the Prepare Sample screen to open the analyzer door.
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Page 16: Review Test Results
10. Upon test completion, patient results will display on the screen. Touch HOME to exit results screen. Figure 13 The screen will provide an indication when it is safe to remove the used cartridge. Figure 14 Figure 13 Figure 14 Review Test Results 1. -
Page 17: Maintenance And Cleaning
5 Maintenance and Cleaning The Element i+ Analyzer is a maintenance-free instrument and has no user serviceable parts. When encountering analyzer failures or damage, please contact service. CAUTION Do not try to open the Analyzer for cleaning or servicing. Cleaning Outside Surfaces Use a soft cloth to clean the Element i+ Analyzer. -
Page 18: Troubleshooting
6 Troubleshooting 6.1. Error Handling When an error occurs, a dialog box appears displaying the error message. The table below describes the warnings and error messages that may be displayed, as well as suggested actions to take. If you are unable to resolve the problem by following this troubleshooting guide, please contact you local Technical Support Services. - Page 19 Error Message Error Type Action Error connecting to hardware. Internal instrument Restart the instrument. If communication. problem persists, contact Heska Technical Support Services. Unexpected error editing reference General error. Confirm reference ranges range. are set in the Administrator settings. Unexpected error deleting General error.
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