scil Element i+ User Manual Download Page 2

 

Vers.:20220531ENG 

 

 

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

 
 
 

 

Summary of Contents for Element i+

Page 1: ...User Manual Immunodiagnostic Analyzer Element i For Veterinary In Vitro Diagnostic Use Only...

Page 2: ...t 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 M...

Page 3: ...8 2 3 Calibration 8 3 Transport Unpacking and Installation 9 3 1 Packaging 9 3 2 Unpacking 9 3 3 Parts List 9 4 Analyzer Operation 10 4 1 Turning the Analyzer On and Off 10 4 2 Main Screens and Contro...

Page 4: ...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 includ...

Page 5: ...s 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 l...

Page 6: ...or 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 adjust...

Page 7: ...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 port...

Page 8: ...n 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...

Page 9: ...ement 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 ana...

Page 10: ...hen 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 shoul...

Page 11: ...s you need them If you want to set the reference areas you must first go to the settings Then go to the administrator and there you will find the button reference groups In this menu you can change th...

Page 12: ...until this file is loaded Use the following procedure to load the CDF 1 Insert the provided USB flash drive Figure 1 with cartridge lot calibration information into any of the four USB ports on the b...

Page 13: ...ingerprints smudges and other contamination Fluorescence illumination and imaging are through the clear plastic component on the bottom of the cartridge 4 6 Running a Sample This section assumes that...

Page 14: ...e 6 5 With the cartridge flat on the bench remove the pull tab from the sample inlet port and discard Use the cartridge handle to steady the flat cartridge while removing the pull tab Figure 7 NOTE Ca...

Page 15: ...re Sample screen to open the analyzer door Figure 9 Insert the cartridge until you feel a click and hear a beep Figures 10 11 Figure 9 Figure 10 Figure 11 9 The test will run automatically A status ba...

Page 16: ...n Figure 13 The screen will provide an indication when it is safe to remove the used cartridge Figure 14 4 8 Review Test Results Figure 13 Figure 14 1 Click on the button Review Tests 2 Now you can se...

Page 17: ...the analyzer can be cleaned by wiping with a mild detergent 70 solution of ethanol or isopropyl alcohol in water or 10 bleach solution CAUTION Do not directly spray the Analyzer with cleaner Apply cle...

Page 18: ...new cartridge Unable to read the barcode from the inserted cartridge Barcode not read Verify that barcode is not damaged and retry the cartridge If error persists select a new cartridge The inserted c...

Page 19: ...ed error editing reference range General error Confirm reference ranges are set in the Administrator settings Unexpected error deleting reference range General error Confirm reference ranges are set i...

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