Icare · Spec-first medical systems
Standardized catalogs, FDA-cleared and CE MDR documentation packs, HL7 FHIR / LIS interfaces, and service tiers your value-analysis committee can score in one sitting.
Reference specifications
Numbers below are catalog baselines for RFP screening. Confirm product-specific IFU, 510(k) summary, and regional registrations before award.
| SpO2 accuracy (1 SD) | ±2% at 70–100% (adult / neonate sensors) |
|---|---|
| NIBP cycle time | Median 28 s adult cuff; STAT mode ≤15 s |
| Telemetry latency | ≤2.5 s end-to-end on hospital WLAN validated profile |
| Interoperability | HL7 FHIR R4 Observation + Epic / Cerner ADT feed |
| Cybersecurity | SBOM publish, IEC 81001-5-1 SDLC, 24h triage / 14d patch window |
| Chair load rating | 182 kg continuous / IEC 60601-1 mechanical |
|---|---|
| Intraoral scan accuracy | ≤20 µm trueness on ISO 12836 full-arch protocol |
| CBCT FOV options | 5×5 to 16×10 cm with DICOM Secondary Capture |
| Autoclave cycle | 134 °C / 2.1 bar / Class B; Bowie-Dick + Class 5 CI |
| Regulatory path | FDA 510(k) cleared line items + CE marked under MDR 2017/745 |
| Chemistry throughput | 400–1,200 tests/h depending on module mix |
|---|---|
| Hematology CV | WBC CV ≤2.5% / RBC CV ≤1.5% (CLSI EP05) |
| LOD / LOQ disclosure | Published per assay; LoB / LoD / LoQ package in DHF |
| LIS interface | HL7 v2.5.1 ORM/ORU + ASTM E1394 middleware |
| QC framework | Westgard multi-rule, Levey-Jennings export, CAP PT ready |
Portfolio
Lean SKU maps for GPO contracting — expand into the full catalog on the products page.
Bedside monitors, central telemetry, wearable biosensors, and RPM kits with FHIR observation push.
Treatment units, intraoral scanners, CBCT, CAD/CAM milling, and Class B autoclaves for DSOs.
Chemistry, hematology, immunoassay, and molecular platforms with CAP / CLIA validation packs.
Why procurement teams shortlist Icare
510(k) substantial equivalence summaries, CE MDR DoC, ISO 13485 cert, and unique device identification (UDI) export in one Spec Library folder.
HL7 FHIR R4, HL7 v2.5.1, DICOM for dental imaging, and LIS middleware notes published per SKU.
MTBF / MTTR targets, remote diagnostics, and spare-parts SLAs in every service quote.
SBOM, CVE triage windows, and FDA premarket cybersecurity guidance mapping per connected device.
Transparent reprocessing limits (steam / ETO / H2O2) versus disposable economics for infection control debates.
Catalog SKUs, GPO contract codes, and quote forms without multi-page storytelling walls.
Share bed count, assay menu, or dental group footprint — we return a TCO worksheet, service tier map, and documentation checklist within two business days. Note operating limits: pulse oximetry SpO2 accuracy depends on perfusion; wearable battery runtime is typically 8 hours continuous monitoring under the validated profile; analyzer coefficient of variation (CV) and limit of detection (LOD) are assay-lot dependent; dental CBCT needs DICOM interoperability with your picture archiving and communication system (PACS) or VNA.