Audited disclosures

Performance Data

Planning metrics for value-analysis committees. Confirm current IFU, model reference, and market labeling before procurement decisions.

Fleet & clinical operations

Year-over-year monitoring performance indicators

Metric	2022	2023	2024	Target 2025
Fleet uptime (contracted Tier-1)	99.42%	99.51%	99.58%	99.60%
Mean time between failures (hours)	18,400	19,200	20,100	21,000
Mean time to repair (hours)	6.8	6.2	5.7	5.4
SpO2 verification pass rate in labeled interval	98.1%	98.4%	98.7%	99.0%
FHIR / HL7 observation delivery success	99.1%	99.3%	99.5%	99.6%
Energy intensity (kWh / monitored bed / yr)	186	174	161	150

Figures are planning ranges for Siemens Healthineers evaluation briefs and do not replace device-specific labeling, clinical studies, or regional registrations. SpO2 verification, FHIR delivery, and uptime rows are method-bound: specimen / patient conditions, network topology, and contract measurement windows must be restated in the acceptance package.

Method boundaries

What these metrics do not claim

Labeled interval only: SpO2 accuracy applies inside the IFU perfusion and motion envelope; low-perfusion or motion cases need separate protocol notes.
Interface ≠ clinical truth: HL7 / FHIR Observation success measures delivery, not waveform fidelity or identity matching under downtime.
Contract measurement windows: Fleet uptime and MTTR exclude force majeure, customer network outages, and unapproved configuration changes unless the SOW says otherwise.
No outcome percentages without study IDs: Clinical efficacy claims require peer-reviewed or labeled evidence attached to the exact model and indication.
Verification path: Hospitals may request IQ/OQ/PQ packets, reference-device SpO2 checks, alarm-priority scripts (IEC 60601-1-8), and interface soak tests before go-live.

Compliance checklist

Certifications and disclosures typically requested in RFP packages

FDA Establishment registration on file — verify by product reference for 510(k) clearance
ISO 13485:2016 quality management system certificate
CE marked under MDR 2017/745 where applicable (Notified Body number on labeling)
IEC 60601-1 / IEC 60601-1-2 electrical safety & EMC evidence
IEC 60601-1-8 alarm system documentation for monitoring fleets
DICOM Conformance Statement / HL7 FHIR implementation notes
Software Bill of Materials (SBOM) and CVE response SLA for connected devices
ISO 14001 / ISO 50001 environmental & energy management where site-certified
RoHS / REACH / WEEE take-back statements for applicable SKUs

Performance Data

Year-over-year monitoring performance indicators

What these metrics do not claim

Certifications and disclosures typically requested in RFP packages

Request the CSV performance pack for your RFP