Technical specifications:
Overview
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System Description
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Point-of-care immunoassay analyzer
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Quantitative Tests
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Hemoglobin A1c (whole blood): Range: 2.5% to 14%
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Test Format
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Self-contained immunoassay cartridges
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Test Measurement
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Automatic, optional transmission
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Test Method
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HbA1c and Microalbumin - monoclonal antibody
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Time to Test Results
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HbA1c - 6 min, A:C Ratio - 7 min
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General
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Dimensions
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9.0 (h) x 11.5 (w) x 10.5 (d) in |
Weight
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3.88 kg (9.0 lbs)
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Power Requirements
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100 to 240 VAC; 50/60 Hz
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Line Leakage Current
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<0.3 mA in normal condition
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Maximum Power Input
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70 VA; 30 watts
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Ambient Operating
Temperature
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18°C to 30°C (64°F to 86°F) -
Microalbumin 15°C to 32°C (61°F to 88°F) - HbA1c |
Operating Humidity
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10 to 90%, relative humidity
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Safety
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UL/CUL with CB Scheme, CSA-C22.2, EN60601,
IEC60601, UL60601 |
EMC Emissions/Immunity
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FCC 47 - Part 15 (Class B), EN60601-1-2 (Class B)
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Test Handling
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Sample Volume
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HbA1c - 1µL whole blood
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Sample Preparation
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No pretreatment; no pipetting required
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Sample ID/Operator ID Entry
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Optional; via touch screen or bar code reader
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Calibration
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Calibration
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Lot-specific calibration card provides automatic calibration |
Onboard Computer
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Storage Capacity/Memory
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4000 patient and/or control records
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Display
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Color touch screen with 1/4 VGA resolution
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Data Export
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Via USB flash drive to PC
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Quality Control/Compliance
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Flexible QC Scheduling
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None, Automatic Reminders or Required
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QC Testing
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Optional lockout if schedule not followed or QC fails
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User/Operator Access
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Restricted, if desired
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Matching Lab Results/
Reference Method |
Adjustable correlation to reference methods |
Reference Ranges
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User-definable reference ranges available for HbA1c
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