| Overview | |
|---|---|
| System Description | Point-of-care immunoassay analyzer |
| Quantitative Tests | Hemoglobin A1c (whole blood): Range: 2.5% to 14% 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 Microalbumin - monoclonal antibody agglutination reaction Creatinine - Benedict Behre chemical reaction |
| Time to Test Results | HbA1c - 6 min, A:C Ratio - 7 min |
| General | |
|---|---|
| Dimensions | 9.0 (h) x 11.5 (w) x 10.5 (d) in 25.4 (h) x 28.7 (w) x 27.7 (d) cm |
| Weight | 3.88 kg (9.0 lbs) |
| Power Requirements | 100 to 240 VAC; 50/60 Hz |
| 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) - Microalbumin 15°C to 32°C (61°F to 88°F) - HbA1c |
| Operating Humidity | 10 to 90%, relative humidity |
| Safety | UL/CUL with CB Scheme, CSA-C22.2, EN60601, IEC60601, UL60601 |
| EMC Emissions/Immunity | FCC 47 - Part 15 (Class B), EN60601-1-2 (Class B) |
| 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 |
| Onboard Computer | |
|---|---|
| Storage Capacity/Memory | 4000 patient and/or control records |
| Display | Color touch screen with 1/4 VGA resolution |
| Data Export | Via USB flash drive to PC |
| 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 |
| 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, bi-directional, ASTM |
| Ethernet Connection | 10/100 Mbit, bi-directional, ASTM |
| 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 |