HyperpolarizedGasDeliverySafetyQC

Hyperpolarized Gas Delivery Safety QC

medical_devices Hyperpolarized Xenon RPH Xe-129 medical gases CSV→JSON URS & FS rule-based
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Utility description: Hyperpolarized Gas Delivery Safety QC

Hyperpolarized Gas Delivery Safety QC — Hyperpolarized Gas Delivery Safety Control

ℹ️  Utility monitors gas administration parameters to patient:
    • Volume dosing accuracy
    • Peak airway pressure
    • Flow rate (turbulence)
    • Oxygen level (hypoxia)

⚠️  CRITICAL: High pressure leads to lung barotrauma!
    Fast flow destroys hyperpolarization before reaching alveoli.

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

Input format:
BatchNumber,ProductName,Delivered_Volume,Target_Volume,Flow_Rate,Peak_Pressure,Max_Pressure,Max_Flow,Min_O2,Measured_O2

Example:
  XE-DELIV-2026-001,HP-Xe-129,0.98,1.0,0.5,15.0,20.0,1.0,19.0,21.0

— WHY IS THIS NEEDED?
Delivery safety is critical for HP-MRI procedures:
• Patient inhales gas under pressure, creating risk of alveolar damage (barotrauma)
• Hyperpolarization is very fragile: turbulent flow (high speed) leads to rapid signal loss
• Dose accuracy is important for quantitative lung ventilation assessment
• Mixture must contain sufficient oxygen to prevent hypoxia

⚠️  CRITICAL:
• Peak pressure ≤20-30 cmH2O (depending on protocol)
• Flow rate must be laminar (usually <1 L/min)
• Volume deviation ≤5%
• Oxygen ≥19%

Key features:
• Real-time pressure monitoring
• Flow rate control for polarization preservation
• Dosing error calculation
• Gas mixture safety check

Critical parameters:
• Peak Pressure: ≤20 cmH2O
• Flow Rate: ≤1.0 L/min
• Volume Error: ≤5%
• O2 Level: ≥19%

💡 Usage tips:
1. Use flow smoothing filters (laminarizers)
2. Calibrate pressure sensors before each study
3. Monitor patient airway resistance (asthma, COPD)
4. Configure emergency shutoff upon pressure exceedance
5. Maintain incident log to improve safety protocols

⚠️ Note: Unlike standard mechanical ventilation, here it is important not only to deliver gas but to do it as "gently" as possible to preserve quantum state of spins. The utility balances between medical safety and physical signal integrity.

input.csv

BatchNumber,ProductName,Delivered_Volume,Target_Volume,Flow_Rate,Peak_Pressure,Max_Pressure,Max_Flow,Min_O2,Measured_O2
XE-DELIV-2026-001,HP-Xe-129 Diagnostic Dose,0.98,1.0,0.5,15.0,20.0,1.0,19.0,21.0
XE-DELIV-2026-002,HP-Xe-129 High Flow,1.0,1.0,1.5,18.0,20.0,1.0,19.0,21.0
XE-DELIV-2026-003,HP-Xe-129 Obstruction,0.8,1.0,0.3,35.0,20.0,1.0,19.0,21.0

URS & FS — user requirements and functional specification

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface and behaviour of HyperpolarizedGasDeliverySafetyQC for “Hyperpolarized Gas Delivery Safety QC”. 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

  • Peak Pressure: ≤20 cmH2O
  • Flow Rate: ≤1.0 L/min
  • Volume Error: ≤5%
  • O2 Level: ≥19%

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 “Hyperpolarized Gas Delivery Safety QC”.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-DELIV-2026-001Batch/lot identifier for traceability.
2ProductNamestringas specifiedHP-Xe-129 Diagnostic DoseName of the controlled product, gas, procedure or equipment.
3Delivered_Volumedecimalas specified0.98Controlled input.csv field: Delivered Volume.
4Target_Volumedecimalas specified1.0Controlled input.csv field: Target Volume.
5Flow_Ratedecimalas specified0.5Gas flow or target flow used to verify blending/delivery.
6Peak_Pressuredecimalas specified15.0Delivery-circuit pressure; a patient and equipment safety parameter.
7Max_Pressuredecimalas specified20.0Delivery-circuit pressure; a patient and equipment safety parameter.
8Max_Flowdecimalas specified1.0Gas flow or target flow used to verify blending/delivery.
9Min_O2decimalas specified19.0Oxygen concentration or flow; a breathing-mixture safety and/or polarization-retention parameter.
10Measured_O2decimalas specified21.0Oxygen concentration or flow; a breathing-mixture safety and/or polarization-retention parameter.
BatchNumber,ProductName,Delivered_Volume,Target_Volume,Flow_Rate,Peak_Pressure,Max_Pressure,Max_Flow,Min_O2,Measured_O2
XE-DELIV-2026-001,HP-Xe-129 Diagnostic Dose,0.98,1.0,0.5,15.0,20.0,1.0,19.0,21.0
XE-DELIV-2026-002,HP-Xe-129 High Flow,1.0,1.0,1.5,18.0,20.0,1.0,19.0,21.0
XE-DELIV-2026-003,HP-Xe-129 Obstruction,0.8,1.0,0.3,35.0,20.0,1.0,19.0,21.0

FS — Functional Specification

IDFunctionImplementation
FS-001CLI executionHyperpolarizedGasDeliverySafetyQC.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 “Hyperpolarized Gas Delivery Safety QC” 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": "hyperpolarized-gas-delivery-safety-qc",
  "primaryTag": "medical_devices",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "XE-DELIV-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProductName",
      "value": "HP-Xe-129 Diagnostic Dose",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Delivered_Volume",
      "value": "0.98",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Target_Volume",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Flow_Rate",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Peak_Pressure",
      "value": "15.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Max_Pressure",
      "value": "20.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Max_Flow",
      "value": "1.0",
      "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

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