OPTI CCA-TS Portable Dry-chemistry Blood Gas and Electrolyte Analyzer
| 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 |
Overview
The OPTI CCA-TS is a compact, portable dry-chemistry blood gas and critical care analyzer engineered for rapid, accurate, and fully integrated measurement of acid-base status, blood gases, electrolytes, oxygenation, and metabolites directly from whole blood. Utilizing proprietary single-use, reagent-impregnated sensor cartridges—eliminating liquid reagents, calibration fluids, or daily maintenance—the system operates on a true dry-chemistry principle with electrochemical (pH, pCO₂, pO₂, Na⁺, K⁺, Cl⁻, iCa²⁺) and enzymatic (glucose, BUN, tHb) detection technologies. Designed for high-reliability point-of-care (POC) deployment, the CCA-TS delivers clinical-grade results in under 90 seconds with minimal operator intervention. Its architecture supports seamless integration into hospital-wide information systems while maintaining full compliance with CLIA, ISO 15189, and CAP requirements for near-patient testing.
Key Features
- True dry-chemistry platform: No liquid reagents, no daily calibration, no waste disposal—reducing consumable cost and environmental footprint.
- Integrated 12-parameter panel: Simultaneous quantification of pH, pCO₂, pO₂, SO₂, Na⁺, K⁺, Cl⁻, iCa²⁺, tHb, glucose, BUN, and calculated parameters (HCO₃⁻, base excess, anion gap, O₂ content).
- Color capacitive touchscreen with intuitive graphical UI: Supports multi-language operation (including English, Spanish, French, German, Chinese, Japanese) and context-sensitive on-screen prompts for error prevention.
- Robust onboard data management: Stores up to 200 patient results with full metadata (sample ID, operator ID, time/date stamp, QC status); retains 35 days of tiered quality control records (Level 1–3) with Levey-Jennings charting capability.
- Dual communication interfaces: RS232 serial port and 10/100 Mbps Ethernet with HL7 v2.x and ASTM E1381-compliant messaging for bidirectional LIS/HIS integration.
- Lifetime software support: Free firmware updates, security patches, and regulatory-compliant software revisions—ensuring long-term interoperability and audit readiness per FDA 21 CFR Part 11 and EU MDR Annex II requirements.
Sample Compatibility & Compliance
The OPTI CCA-TS accepts heparinized arterial, venous, and capillary whole blood samples (0.12 mL volume requirement) without preprocessing. Cartridge design incorporates integrated sample aspiration and automatic clot detection to prevent erroneous readings from microclots or air bubbles. All assays are validated per CLSI EP05-A3 (precision), EP06-A (linearity), and EP15-A3 (reagent lot-to-lot consistency) protocols. The device carries CE marking under IVDR Class B, FDA 510(k) clearance (K192978), and complies with ISO 13485:2016 quality management standards. It meets IEC 61010-1 safety requirements and IEC 60601-1-11 for use in home healthcare and mobile environments (e.g., ambulances, field hospitals).
Software & Data Management
Embedded OPTI Connect™ software provides real-time result visualization, trend analysis, and automated QC flagging (Westgard rules). Audit trail functionality captures all user actions—including result edits, QC overrides, and cartridge lot changes—with immutable timestamps and operator authentication. Data export supports CSV, PDF, and XML formats; HL7 ADT/Ack and ORU messages enable automated patient demographic synchronization and result reporting. Optional OPTI DataLink™ server software allows centralized fleet monitoring, remote diagnostics, and aggregated analytics across multiple CCA-TS units within a health system.
Applications
The OPTI CCA-TS serves as a primary or confirmatory analyzer in diverse clinical settings: rapid assessment of respiratory failure and metabolic derangements in emergency departments; titration of ventilator settings and hemodynamic support in ICUs and CCUs; intraoperative monitoring during cardiac and transplant surgeries; triage and stabilization in pre-hospital transport; and routine metabolic screening in outpatient clinics. Its portability and battery-powered operation (up to 8 hours continuous use) make it suitable for disaster response, military medicine, and low-resource environments where infrastructure reliability is constrained.
FAQ
What sample types are compatible with the OPTI CCA-TS?
Arterial, venous, and capillary whole blood collected in lithium heparin or sodium heparin tubes—no centrifugation or plasma separation required.
Does the system require daily calibration or maintenance?
No. Each single-use cartridge contains factory-calibrated sensors and embedded reagents; only cartridge insertion and sample application are needed before analysis.
How is data security and regulatory compliance ensured?
The system implements role-based access control, encrypted audit trails, electronic signatures, and full 21 CFR Part 11 compliance—including electronic record retention, change control, and system validation documentation.
Can the CCA-TS be integrated with existing hospital IT infrastructure?
Yes. Native HL7 v2.x and ASTM support enables plug-and-play connectivity with major LIS, HIS, and EMR platforms—including Epic, Cerner, and Meditech—without third-party middleware.
What is the shelf life and storage condition for OPTI cartridges?
Cartridges are stable for 12 months when stored at 2–30°C; no refrigeration required. Lot-specific calibration data is auto-read via RFID tag upon insertion.
