Specifications |
Overview | |
System Description |
Point-of-care immunoassay analyzer |
Quantitative Tests |
Hemoglobin A1c (whole blood): Range: 2.5% to 14% (4mmol/mol to 130 mmol/mol) Microalbumin/Creatinine (urine): Single test reports all three results for: Albumin: 5 to 300 mg/L; Creatinine: 15 to 500 mg/dL (1.3 to 44.2 mmol/L); Albumin-to Creatinine Ratio: 1 to 2000 mg/g (0.11 to 226 mg/mmol) |
Test Format |
Self-contained immunoassay cartridges |
Test Measurement |
Automatic, optional transmission |
Test Method |
HbA1c and Albumin: monoclonal antibody agglutination reaction Creatinine - Benedict Behre chemical reaction |
Time to Test Results |
HbA1c - 6 minutes |
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A:C Ratio - 7 minutes |
Test Handling | |
Sample Volume |
HbA1c - 1µL whole blood Microalbumin/Creatinine - 40µL urine |
Sample Preparation |
No pretreatment; no pipetting required |
Sample ID/Operator ID Entry |
Optional; via touch screen or bar code reader |
Calibration | |
Calibration |
Lot-specific calibration card provides automatic calibration with every cartridge
Traceable to International Federation of Clinical Chemistry (IFCC) reference materials and test methods for measurement of HbA1c
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Onboard Computer | |
Storage Capacity/Memory |
4000 patient and/or control records Up to 1,000 operator IDs |
Display |
Color touch screen with 1/4 VGA resolution |
Data Export |
Via USB flash drive to PC or direct to LIS/HIS or data manager, if interfaced |
Quality Control/Compliance | |
Flexible QC Scheduling |
None, Automatic Reminders or Required |
QC Testing |
Optional lockout if schedule not followed or QC fails |
User/Operator Access |
Restricted, if desired, to protect patient and QC data and prevent unauthorized use |
Matching Lab Results/ Reference Method |
Adjustable correlation to reference methods |
Reference Ranges |
User-definable reference ranges available for HbA1c |
Computer/Peripheral Interfaces | |
Serial Port |
RS232, ASTM |
Ethernet Connection |
ASTM or POCT1-A2 |
Bi-Directional Capabilities |
ASTM: Remote computer can be set up to lock out patient tests POCT1-A2: Remote computer can be set up to lock out patient tests, and send operator list to analyzer |
USB-Port |
Standard USB 2.0 |
External Bar Code Reader (optional) |
Serial (9 pin) |
Onboard Printer |
54 mm (2 in) width, thermal/label stock |
External Printer |
Supports standard PCL printer interface via USB port |
General | |
Dimensions |
9.0 (h) x 11.5 (w) x 10.5 (d) inches 25.4 (h) x 28.7 (w) x 27.7 (d) cm
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Weight |
3.88 kg (9.0 lb)
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Power Requirements |
100 to 240 VAC; 50/60 Hz
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Line Leakage Current |
<0.3 mA in normal condition <0.5 mA in single fault condition
|
Maximum Power Input |
70 VA; 30 watts
|
Ambient Operating Temperature |
18°C to 30°C (64°F to 86°F) (Albumin) 15°C to 32°C (61°F to 88°F) (HbA1c)
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Operating Temperature
|
° |
Safety |
TUV SUD with CB Scheme, CSA-C22.2, EN60601, IEC 60601, UL60601
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EMC Emissions/Immunity |
FCC 47: Part 15 (Class B), EN60601-1-2 (Class B)
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