| Point-of-care immunoassay analyzer |
| 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) |
| Self-contained immunoassay cartridges |
| Automatic, optional transmission |
| HbA1c: monoclonal antibody agglutination reaction Albumin: polyclonal goat anti-human albumin antiserum Creatinine: Benedict Behre chemical reaction |
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| HbA1c - 1µL whole blood Microalbumin/Creatinine - 40µL urine |
| No pretreatment; no pipetting required |
Sample ID/Operator ID Entry | Optional; via touch screen or bar code reader |
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| 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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| 4000 patient and/or control records Up to 1,000 operator IDs |
| Color touch screen with 1/4 VGA resolution |
| Via USB flash drive to PC or direct to LIS/HIS or data manager, if interfaced |
Quality Control/Compliance | |
| None, Automatic Reminders or Required |
| Optional lockout if schedule not followed or QC fails |
| Restricted, if desired, to protect patient and QC data and prevent unauthorized use |
Matching Lab Results/ Reference Method | Adjustable correlation to reference methods
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| User-definable reference ranges available for HbA1c |
Computer/Peripheral Interfaces | |
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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 |
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External Bar Code Reader (optional) | |
| 54 mm (2 in) width, thermal/label stock |
| Supports standard PCL printer interface via USB port |
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| 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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| <0.3 mA in normal condition <0.5 mA in single fault condition |
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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) |
| 5°C to 40°C (41°F to 104°F); 15% to 90% relative humidity |
| TUV SUD with CB Scheme, CSA-C22.2, EN60601, IEC 60601, UL60601 |
| FCC 47: Part 15 (Class B), EN60601-1-2 (Class B) |