Xe129PolarizationLevelChecker

Xe-129 Polarization Level Checker

instrumental Hyperpolarized Xenon RPH Xe-129 medical gases CSV→JSON URS & FS rule-based

Utility description: Xe-129 Polarization Level Checker

Xe-129 Polarization Level Checker — Xe-129 Polarization Level Analyzer

ℹ️  Utility controls key parameter of hyperpolarized MRI:
    • Absolute polarization level (%)
    • Signal enhancement factor relative to thermal equilibrium
    • Deviation from target value

⚠️  CRITICAL: Low polarization = no signal on image!
    Minimum 10-15% required for quality lung visualization.

Usage:
  Xe129PolarizationLevelChecker.exe                            → demo mode (console output)
  Xe129PolarizationLevelChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,ProductName,Measured_Pol_Percent,Thermal_Signal,HP_Signal,Pumping_Time_Min,Laser_W,Min_Pol,Target_Pol

Example:
  POL-XE129-2026-001,HP-Xe-129,15.5,1.0,45000,45,100,10,20

— WHY IS THIS NEEDED?
Polarization control is critical for HP-MRI procedure success:
• MRI signal is directly proportional to Xe-129 nuclei polarization level
• Without sufficient polarization (>10%), image will be too noisy for diagnostics
• Polarization level depends on laser power, pumping time and gas purity
• Utility allows rejecting poor quality gas batches before patient administration
• Helps optimize polarizer operation time (balance between polarization degree and throughput)

⚠️  CRITICAL:
• Minimum polarization level ≥10% (for standard 1.5T/3T scanners)
• Signal enhancement factor ≥10,000x compared to thermal equilibrium
• Polarimeter reading stability
• Pumping time control (too short = low polarization, too long = time loss)

Key features:
• Enhancement Factor calculation
• Comparison with target efficiency indicators
• Laser system or gas mixture problem detection
• Support for various polarizer operation modes

Critical parameters:
• Polarization Level: ≥10%
• Enhancement Factor: ≥10,000x
• Target Deviation: ≤20%

💡 Usage tips:
1. Calibrate polarimeter before each measurement series
2. Account for gas transport time from polarizer to scanner (T1 decay)
3. Compare current indicators with historical data to detect equipment degradation
4. For high-resolution studies aim for polarization >20%
5. Maintain polarization level log for each gas batch

⚠️ Note: Unlike standard MRI where signal is determined by proton density, here signal is created artificially. The utility guarantees that this "artificial" signal is strong enough to overcome thermal noise.

input.csv

BatchNumber,ProductName,Measured_Pol_Percent,Thermal_Signal,HP_Signal,Pumping_Time_Min,Laser_W,Min_Pol,Target_Pol
POL-XE129-2026-001,HP-Xe-129 (90%),15.5,1.0,45000,45,100,10,20
POL-XE129-2026-002,HP-Xe-129 (Failed),5.0,1.0,12000,45,100,10,20
POL-XE129-2026-003,HP-Xe-129 (High Perf),22.0,1.0,65000,60,120,10,20

URS & FS — user requirements and functional specification

URS & FS — User Requirements and Functional Specification

This document defines the controlled interface and behaviour of Xe129PolarizationLevelChecker for “Xe-129 Polarization Level 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

Polarization Level: ≥10%
Enhancement Factor: ≥10,000x
Target Deviation: ≤20%

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept `input.csv` with the exact headers defined by the data contract.	High	The file is processed without manual header renaming.
URS-002	The utility shall perform a deterministic assessment for “Xe-129 Polarization Level Checker”.	High	PASS / WARNING / FAIL is produced for each row.
URS-003	Required fields, types, ranges, units and data consistency shall be validated before domain rules.	High	Schema errors are separated from nonconformities.
URS-004	Critical limits from the description and approved local configuration shall create a critical finding.	High	A critical rule violation results in FAIL.
URS-005	The result shall be written to machine-readable `output.json`.	High	JSON contains source values, checks, warnings and failures.
URS-006	The conformity decision shall not use machine learning.	Medium	The result is reproducible from explicit rules and inputs.
URS-007	Traceability of batch, source file, rule version and final status shall be retained.	High	QA/QC can reproduce the decision.
URS-008	The utility shall have exactly one primary portal tag: `instrumental`.	Medium	The other api / instrumental / medical_devices tags are absent.
URS-009	Documentation shall support IQ/OQ/PQ or equivalent CSA/CSV verification.	Medium	The contract, test scenarios and change-control rules are supplied with the utility.

input.csv data contract

#	Field	Type	Unit	Sample	Purpose
1	`BatchNumber`	string	as specified	`POL-XE129-2026-001`	Batch/lot identifier for traceability.
2	`ProductName`	string	as specified	`HP-Xe-129 (90%)`	Name of the controlled product, gas, procedure or equipment.
3	`Measured_Pol_Percent`	decimal	%	`15.5`	Xe-129 hyperpolarization level, loss or target parameter.
4	`Thermal_Signal`	decimal	as specified	`1.0`	Measured signal used for SNR, uniformity or polarization-efficiency assessment.
5	`HP_Signal`	decimal	as specified	`45000`	Measured signal used for SNR, uniformity or polarization-efficiency assessment.
6	`Pumping_Time_Min`	decimal	min	`45`	Time parameter for processing, relaxation, pumping or examination.
7	`Laser_W`	decimal	W	`100`	SEOP laser-system parameter.
8	`Min_Pol`	decimal	as specified	`10`	Xe-129 hyperpolarization level, loss or target parameter.
9	`Target_Pol`	decimal	as specified	`20`	Xe-129 hyperpolarization level, loss or target parameter.

BatchNumber,ProductName,Measured_Pol_Percent,Thermal_Signal,HP_Signal,Pumping_Time_Min,Laser_W,Min_Pol,Target_Pol
POL-XE129-2026-001,HP-Xe-129 (90%),15.5,1.0,45000,45,100,10,20
POL-XE129-2026-002,HP-Xe-129 (Failed),5.0,1.0,12000,45,100,10,20
POL-XE129-2026-003,HP-Xe-129 (High Perf),22.0,1.0,65000,60,120,10,20

FS — Functional Specification

ID	Function	Implementation
FS-001	CLI execution	`Xe129PolarizationLevelChecker.exe` supports demo mode and `input.csv output.json` mode.
FS-002	CSV import	Read UTF-8 CSV and validate header, column count and order.
FS-003	Schema validation	Validate required values, empties, types and basic plausibility.
FS-004	Domain rule engine	Apply explicit rules for “Xe-129 Polarization Level Checker” and locally approved limits.
FS-005	Status aggregation	FAIL for a critical finding; WARNING for a non-critical deviation; PASS for conformity.
FS-006	JSON export	Write source values, applied rules, statuses, warnings, failures and configuration version.
FS-007	Audit support	Retain a result structure suitable for review, investigation, IQ/OQ and change control.
FS-008	Integration contract	LIMS/ELN/MES or an instrument wrapper creates CSV; the utility returns JSON.

output.json example

{
  "utilityId": "xe129-polarization-level-checker",
  "primaryTag": "instrumental",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "POL-XE129-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ProductName",
      "value": "HP-Xe-129 (90%)",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Measured_Pol_Percent",
      "value": "15.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Thermal_Signal",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "HP_Signal",
      "value": "45000",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Pumping_Time_Min",
      "value": "45",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Laser_W",
      "value": "100",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Min_Pol",
      "value": "10",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "warnings": [],
  "criticalFindings": []
}

OQ/PQ test scenarios

ID	Scenario	Expected result
OQ-001	Valid example row	PASS or an allowed WARNING under local rules.
OQ-002	Required column missing	Schema error; domain checks do not mask it.
OQ-003	Non-numeric value in numeric field	Type-conversion error.
OQ-004	Critical parameter outside its limit	FAIL and a critical finding.
OQ-005	Boundary value	The result follows the configured ≤ / ≥ / < / > operator.
PQ-001	Real site data	Agreed 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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Xe-127, Xe-129 and Xe-133 for ventilation, hyperpolarized imaging, gas QC and safety.

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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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RPH workflow: dosimetry and therapy planning

Activity planning, absorbed dose, organ dose, lung shunt, preplanning and therapy verification.

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RPH workflow: imaging QC and quantitative interpretation

Acquisition, uptake, clearance, perfusion, transit, ejection fraction, segmentation and quantitative imaging.

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RPH workflow: stability, storage, decay and waste

Kinetic stability, shelf life, decay correction, expiry, storage, trend and radioactive waste.

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