OPTI
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| Brand | OPTI |
|---|---|
| Origin | USA |
| Model | OPTI CCA |
| Measurement Principles | Fluorescence-based optical sensing (pO₂, pCO₂), Reflectance photometry (pH, tHb, SO₂), Ion-selective field-effect transistor (ISFET) for electrolytes (Na⁺, K⁺, Ca²⁺, Cl⁻), Enzymatic electrochemical detection (Glu) |
| Sample Volume | 95 µL whole blood (arterial, venous, capillary) |
| Test Time | ≤85 seconds |
| Calibration | Factory-calibrated disposable cartridges, no user calibration required |
| Data Storage | Internal memory for ≥10,000 patient results with timestamps, operator IDs, and QC records |
| Connectivity | USB, RS-232, optional HL7 v2.x over Ethernet |
| Regulatory Compliance | FDA 510(k) cleared, CE-IVD, ISO 13485 certified, CLIA-waived for certain test panels |
| Power | Rechargeable Li-ion battery (≥8 hours continuous operation), auto-switching AC/DC |
| Brand | OPTI |
|---|---|
| Origin | USA |
| Model | OPTI CCA-TS |
| Measurement Parameters | pH, pCO₂, pO₂, Na⁺, K⁺, Cl⁻, iCa²⁺, SO₂, tHb, Glucose, BUN |
| Display | Color touchscreen interface |
| Data Storage | 200 patient records + 35-day tiered QC logs |
| Connectivity | RS232 and Ethernet |
| Software | Lifetime free firmware and software updates |
| Regulatory Status | CE-IVD, FDA 510(k)-cleared (K192978), ISO 13485 certified |
| Intended Use | Point-of-care and central laboratory testing of arterial, venous, and capillary whole blood samples |
| Brand | OPTI |
|---|---|
| Origin | USA |
| Model | OPTI LION |
| Type | Dry-chemistry, Single-use Cartridge-based Electrolyte Analyzer |
| Measurement Parameters | pH, Na⁺, K⁺, Cl⁻, Ca²⁺ (including ionized calcium and standardized corrected calcium at pH 7.4) |
| Interface | Color Touchscreen with Multilingual Support (including English) |
| Barcode Scanner | Integrated |
| Quality Control | On-board QC with Statistical Analysis (Mean, SD, CV, Levey-Jennings charts) |
| Software | FDA 21 CFR Part 11–compliant firmware with Lifetime Free Updates |
| Regulatory Status | CE-IVD, FDA 510(k)-cleared |
| Compliance | Meets CLIA, ISO 15197, ISO 22870, and ASTM E2573 standards for point-of-care and core laboratory use |
| Brand | OPTI |
|---|---|
| Origin | USA |
| Model | OPTI R |
| Measurement Principles | Optical Fluorescence (pO₂), Severinghaus-type CO₂ Sensor (pCO₂), Potentiometric Ion-Selective Electrodes (pH, Na⁺, K⁺, Ca²⁺), Spectrophotometric Hemoglobin Detection (tHb, SO₂) |
| Sample Type | Whole blood (arterial, venous, capillary), heparinized |
| Test Time | ≤ 60 seconds per sample |
| Cartridge Capacity | 50 tests per single-use disposable cartridge |
| Onboard QC | Three-level automated quality control with integrated calibrators |
| Data Storage | 300 patient results + 60 days of QC records (3 levels) |
| Interface | Built-in barcode scanner, RS232/USB, LIS/HIS-compatible software |
| Display | 7-inch color touchscreen with intuitive graphical UI |
| Regulatory Compliance | FDA 510(k) cleared, CE IVD, ISO 13485 certified |