| 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 |
| |
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
|
| 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
|
| Weight |
3.88 kg (9.0 lb)
|
| 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) (Albumin)
15°C to 32°C (61°F to 88°F) (HbA1c)
|
|
Operating Temperature
|
° |
| Safety |
TUV SUD with CB Scheme, CSA-C22.2,
EN60601, IEC 60601, UL60601
|
| EMC Emissions/Immunity |
FCC 47: Part 15 (Class B),
EN60601-1-2 (Class B)
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