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