TriMixGasCompositionVerifier

TriMix Gas Composition Verifier

api Hyperpolarized Xenon RPH Xe-129 medical gases CSV→JSON URS & FS rule-based
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Utility description: TriMix Gas Composition Verifier

TriMix Gas Composition Verifier — TriMix (Xe/N2/O2) Gas Composition Verifier

ℹ️  Utility checks mixing accuracy of Xe / N2 / O2:
    • Deviation of each component from target
    • Absolute oxygen safety level
    • Gas sum balance (100%)

⚠️  CRITICAL: N2/O2 balance error affects T1 and safety!
    Nitrogen extends polarization but displaces oxygen.

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

Input format:
BatchNumber,ProductName,Target_Xe,Target_N2,Target_O2,Measured_Xe,Measured_N2,Measured_O2,Max_Dev,Min_Safe_O2

Example:
  MIX-2026-001,TriMix,70,9,21,69.5,9.2,21.3,1.0,19.0

— WHY IS THIS NEEDED?
Mixture verification is critical for HP-MRI procedure optimization:
• Xenon (Xe) — active imaging agent
• Nitrogen (N2) — buffer gas increasing T1 relaxation time (diamagnetic)
• Oxygen (O2) — necessary for patient life but kills polarization (paramagnetic)
• Precise balance between N2 and O2 allows maximizing signal lifetime while maintaining safety
• Mass Flow Controller (MFC) errors can lead to dangerous hypoxia or signal loss

⚠️  CRITICAL:
• Component deviation ≤1% from target value
• Oxygen ≥19% (absolute safety minimum)
• Sum of all gases must equal 100% ±1% (data integrity check)
• MFC calibration check before each mixing series

Key features:
• Multi-component deviation analysis
• Priority oxygen safety check
• Mixture mass-balance control
• Support for various recipes (Standard, High-N2, Low-O2)

Critical parameters:
• Deviation: ≤1%
• O2 Level: ≥19%
• Balance Error: ≤1%

💡 Usage tips:
1. Use certified gas analyzers to verify mixer output
2. Perform test runs before launching expensive enriched xenon
3. Account for sensor response time during dynamic mixing
4. Maintain deviation log to detect MFC calibration drift
5. Configure emergency alarm for O2 drop below 19%

⚠️ Note: Unlike binary mixtures, here changing one component requires recalculating two others. The utility helps maintain this fragile three-way balance, ensuring both image quality and patient life.

input.csv

BatchNumber,ProductName,Target_Xe,Target_N2,Target_O2,Measured_Xe,Measured_N2,Measured_O2,Max_Dev,Min_Safe_O2
MIX-2026-001,HP-Xe-129 TriMix (Standard),70,9,21,69.5,9.2,21.3,1.0,19.0
MIX-2026-002,HP-Xe-129 TriMix (High N2),60,19,21,58.0,20.5,21.5,1.0,19.0
MIX-2026-003,HP-Xe-129 TriMix (Failed O2),70,9,21,70.0,9.0,18.0,1.0,19.0

URS & FS — user requirements and functional specification

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface and behaviour of TriMixGasCompositionVerifier for “TriMix Gas Composition Verifier”. 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

  • Deviation: ≤1%
  • O2 Level: ≥19%
  • Balance Error: ≤1%

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 “TriMix Gas Composition Verifier”.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: api.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 specifiedMIX-2026-001Batch/lot identifier for traceability.
2ProductNamestringas specifiedHP-Xe-129 TriMix (Standard)Name of the controlled product, gas, procedure or equipment.
3Target_Xedecimalas specified70Xenon parameter: concentration, isotope fraction, activity, volume or purity depending on the field.
4Target_N2decimalas specified9Controlled input.csv field: Target N2.
5Target_O2decimalas specified21Oxygen concentration or flow; a breathing-mixture safety and/or polarization-retention parameter.
6Measured_Xedecimalas specified69.5Xenon parameter: concentration, isotope fraction, activity, volume or purity depending on the field.
7Measured_N2decimalas specified9.2Controlled input.csv field: Measured N2.
8Measured_O2decimalas specified21.3Oxygen concentration or flow; a breathing-mixture safety and/or polarization-retention parameter.
9Max_Devdecimalas specified1.0Controlled input.csv field: Max Dev.
10Min_Safe_O2decimalas specified19.0Oxygen concentration or flow; a breathing-mixture safety and/or polarization-retention parameter.
BatchNumber,ProductName,Target_Xe,Target_N2,Target_O2,Measured_Xe,Measured_N2,Measured_O2,Max_Dev,Min_Safe_O2
MIX-2026-001,HP-Xe-129 TriMix (Standard),70,9,21,69.5,9.2,21.3,1.0,19.0
MIX-2026-002,HP-Xe-129 TriMix (High N2),60,19,21,58.0,20.5,21.5,1.0,19.0
MIX-2026-003,HP-Xe-129 TriMix (Failed O2),70,9,21,70.0,9.0,18.0,1.0,19.0

FS — Functional Specification

IDFunctionImplementation
FS-001CLI executionTriMixGasCompositionVerifier.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 “TriMix Gas Composition Verifier” 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": "tri-mix-gas-composition-verifier",
  "primaryTag": "api",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "MIX-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProductName",
      "value": "HP-Xe-129 TriMix (Standard)",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Target_Xe",
      "value": "70",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Target_N2",
      "value": "9",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Target_O2",
      "value": "21",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Measured_Xe",
      "value": "69.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Measured_N2",
      "value": "9.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Measured_O2",
      "value": "21.3",
      "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

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RPH use case: xenon, ventilation and medical gases

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