GasMixingRatioAndHypoxiaRiskChecker

Gas Mixing Ratio & Hypoxia Risk Checker

medical_devices Hyperpolarized Xenon RPH Xe-129 medical gases CSV→JSON URS & FS rule-based
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Utility description: Gas Mixing Ratio & Hypoxia Risk Checker

Gas Mixing Ratio & Hypoxia Risk Checker — Gas Mixing Ratio and Hypoxia Risk Analyzer

ℹ️  Utility controls breathing mixture safety:
    • Oxygen level (≥19-21%)
    • Xenon level (≤30% for conscious patients)
    • Gas balance (100%)
    • Hypoxia risk index

⚠️  CRITICAL: Xenon displaces oxygen!
    Incorrect mixture leads to rapid loss of consciousness or hypoxia.

Usage:
  GasMixingRatioAndHypoxiaRiskChecker.exe                            → demo mode (console output)
  GasMixingRatioAndHypoxiaRiskChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,ProductName,Xe_Conc_Percent,O2_Conc_Percent,N2_Conc_Percent,Min_O2_Level,Max_Xe_Level

Example:
  XE-MIX-2026-001,HP-Xe-129 Mix,25.0,21.0,54.0,19.0,30.0

— WHY IS THIS NEEDED?
Gas mixture control is critical for patient safety in HP-MRI:
• Xenon is an inert gas but acts as an anesthetic at high concentrations
• Adding xenon to breathing mixture proportionally reduces oxygen share
• If O2 level drops below 19%, tissue hypoxia risk occurs
• If Xe level exceeds 30-35%, patient may lose consciousness directly in scanner
• Nitrogen (N2) is used as buffer gas to balance pressure and concentration

⚠️  CRITICAL:
• Oxygen ≥19-21% — mandatory condition for breathing without support
• Xenon ≤30% — limit for maintaining consciousness in adult patient
• Sum of all gases must equal 100% (gas analyzer integrity check)
• Automatic gas delivery lockout upon parameter deviation

Key features:
• Real-time hypoxia risk index calculation
• Xenon anesthetic threshold control
• Gas analyzer data integrity check (Mass Balance)
• Support for various mixing protocols (binary and ternary mixtures)

Critical parameters:
• O2 Level: ≥19%
• Xe Level: ≤30%
• Total Sum: 100% ± 1%
• Hypoxia Risk Score: < 5

💡 Usage tips:
1. Use certified medical gas analyzers
2. Calibrate oxygen sensors before each working day
3. Configure emergency alarm for O2 drop below 19%
4. Account for patient's physiological oxygen consumption when calculating session duration
5. For patients with pulmonary diseases, increase minimum O2 threshold to 23-25%

⚠️ Note: Unlike standard drugs where dose is measured in milligrams, here dose is percentage content in each breath. Mixer error of even 1-2% can have fatal consequences within minutes. The utility ensures continuous monitoring of this balance.

input.csv

BatchNumber,ProductName,Xe_Conc_Percent,O2_Conc_Percent,N2_Conc_Percent,Min_O2_Level,Max_Xe_Level
XE-MIX-2026-001,HP-Xe-129 Diagnostic Mix,25.0,21.0,54.0,19.0,30.0
XE-MIX-2026-002,HP-Xe-129 High-Conc,35.0,18.0,47.0,19.0,30.0
XE-MIX-2026-003,HP-Xe-129 Safe Mix,20.0,25.0,55.0,19.0,30.0

URS & FS — user requirements and functional specification

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface and behaviour of GasMixingRatioAndHypoxiaRiskChecker for “Gas Mixing Ratio & Hypoxia Risk Checker”. Limits from the source description are an initial configuration and shall be reconciled with the approved specification, study protocol, equipment instructions and local SOPs before production use.

Domain constraints and critical parameters

  • O2 Level: ≥19%
  • Xe Level: ≤30%
  • Total Sum: 100% ± 1%
  • Hypoxia Risk Score: < 5

URS — User Requirements Specification

IDRequirementCriticalityAcceptance criterion
URS-001The utility shall accept input.csv with the exact headers defined by the data contract.HighThe file is processed without manual header renaming.
URS-002The utility shall perform a deterministic assessment for “Gas Mixing Ratio & Hypoxia Risk Checker”.HighPASS / WARNING / FAIL is produced for each row.
URS-003Required fields, types, ranges, units and data consistency shall be validated before domain rules.HighSchema errors are separated from nonconformities.
URS-004Critical limits from the description and approved local configuration shall create a critical finding.HighA critical rule violation results in FAIL.
URS-005The result shall be written to machine-readable output.json.HighJSON contains source values, checks, warnings and failures.
URS-006The conformity decision shall not use machine learning.MediumThe result is reproducible from explicit rules and inputs.
URS-007Traceability of batch, source file, rule version and final status shall be retained.HighQA/QC can reproduce the decision.
URS-008The utility shall have exactly one primary portal tag: medical_devices.MediumThe other api / instrumental / medical_devices tags are absent.
URS-009Documentation shall support IQ/OQ/PQ or equivalent CSA/CSV verification.MediumThe contract, test scenarios and change-control rules are supplied with the utility.

input.csv data contract

#FieldTypeUnitSamplePurpose
1BatchNumberstringas specifiedXE-MIX-2026-001Batch/lot identifier for traceability.
2ProductNamestringas specifiedHP-Xe-129 Diagnostic MixName of the controlled product, gas, procedure or equipment.
3Xe_Conc_Percentdecimal%25.0Xenon parameter: concentration, isotope fraction, activity, volume or purity depending on the field.
4O2_Conc_Percentdecimal%21.0Oxygen concentration or flow; a breathing-mixture safety and/or polarization-retention parameter.
5N2_Conc_Percentdecimal%54.0Controlled input.csv field: N2 Conc Percent.
6Min_O2_LeveldecimalL19.0Oxygen concentration or flow; a breathing-mixture safety and/or polarization-retention parameter.
7Max_Xe_LeveldecimalL30.0Xenon parameter: concentration, isotope fraction, activity, volume or purity depending on the field.
BatchNumber,ProductName,Xe_Conc_Percent,O2_Conc_Percent,N2_Conc_Percent,Min_O2_Level,Max_Xe_Level
XE-MIX-2026-001,HP-Xe-129 Diagnostic Mix,25.0,21.0,54.0,19.0,30.0
XE-MIX-2026-002,HP-Xe-129 High-Conc,35.0,18.0,47.0,19.0,30.0
XE-MIX-2026-003,HP-Xe-129 Safe Mix,20.0,25.0,55.0,19.0,30.0

FS — Functional Specification

IDFunctionImplementation
FS-001CLI executionGasMixingRatioAndHypoxiaRiskChecker.exe supports demo mode and input.csv output.json mode.
FS-002CSV importRead UTF-8 CSV and validate header, column count and order.
FS-003Schema validationValidate required values, empties, types and basic plausibility.
FS-004Domain rule engineApply explicit rules for “Gas Mixing Ratio & Hypoxia Risk Checker” and locally approved limits.
FS-005Status aggregationFAIL for a critical finding; WARNING for a non-critical deviation; PASS for conformity.
FS-006JSON exportWrite source values, applied rules, statuses, warnings, failures and configuration version.
FS-007Audit supportRetain a result structure suitable for review, investigation, IQ/OQ and change control.
FS-008Integration contractLIMS/ELN/MES or an instrument wrapper creates CSV; the utility returns JSON.

output.json example

{
  "utilityId": "gas-mixing-ratio-and-hypoxia-risk-checker",
  "primaryTag": "medical_devices",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "XE-MIX-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProductName",
      "value": "HP-Xe-129 Diagnostic Mix",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Xe_Conc_Percent",
      "value": "25.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "O2_Conc_Percent",
      "value": "21.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "N2_Conc_Percent",
      "value": "54.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Min_O2_Level",
      "value": "19.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Max_Xe_Level",
      "value": "30.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "warnings": [],
  "criticalFindings": []
}

OQ/PQ test scenarios

IDScenarioExpected result
OQ-001Valid example rowPASS or an allowed WARNING under local rules.
OQ-002Required column missingSchema error; domain checks do not mask it.
OQ-003Non-numeric value in numeric fieldType-conversion error.
OQ-004Critical parameter outside its limitFAIL and a critical finding.
OQ-005Boundary valueThe result follows the configured ≤ / ≥ / < / > operator.
PQ-001Real site dataAgreed QA/QC review retaining CSV, JSON, version and checksum.

QA/QC and change control

  • Do not change column names without updating the validator, documentation and test set.
  • Retain input.csv, output.json, executable version, rule version and checksums.
  • Before production use, verify local limits and execute IQ/OQ/PQ or equivalent CSA.
  • Changes affecting patient safety, dosimetry, gas composition, polarization or equipment require documented impact assessment.

Included in packages

Rph Hyperpolarized Xenon Lifecycle QC Suite

29 utilities for the hyperpolarized xenon lifecycle: isotope composition and gas purity, SEOP and polarization, T1/storage/transport, safe blending and delivery, MRI/SPECT QC, dosimetry, scavenging, recovery and recycling.

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RPH isotope family: xenon and gas tracers

Xe-127, Xe-129 and Xe-133 for ventilation, hyperpolarized imaging, gas QC and safety.

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RPH organ/system: hepatobiliary and GI

HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.

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RPH organ/system: pulmonary and ventilation

Lung perfusion, MAA, V/Q, aerosol, xenon ventilation, shunt and pulmonary dosimetry.

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RPH use case: xenon, ventilation and medical gases

Xe-129, Xe-133, Xe-127, hyperpolarization, SEOP, T1, mixing, scavenging, transport, recovery and ventilation imaging.

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