Atch. 1 Pulmonary Function Test Requirements (1).docx

Pulmonary Function Test (PFT) Equipment Requirements List Dated 25 April 2025 This list outlines the requirements for PFT equipment, categorized for clarity.

I. Essential Features & Functionality

· Measurement Capabilities:

· Must have all requirements for Spirometry according to the European Respiratory Society/American Thoracic Society (ERS/ATS) standards

· Forced Vital Capacity (FVC)

· Slow Vital Capacity (SVC)

· Forced Expiratory Volume in 1 second (FEV1)

· FEV1/FVC ratio

· Maximum Voluntary Ventilation (MVV)

· Peak Expiratory Flow (PEF)

· Peak Inspiratory Flow (PIF)

· Forced Expiratory Flow at 25-75% of FVC (FEF25-75%)

· Flow-volume loops

· Volume-time curves

· Calculation of Z-scores (the number of standard deviations (SD) in which a parameter deviates from the center of the bell, or the predicted value)

· Must have all requirements for Body Plethsmography to measure lung volumes according to the European Respiratory Society/American Thoracic Society (ERS/ATS) standards

· Body plethysmography: For more accurate lung volume measurements, especially in patients with airflow obstruction.

· Total Lung Capacity (TLC) - using either gas dilution or plethysmography techniques

· Residual Volume (RV)

· Functional Residual Capacity (FRC)

· Must have all requirements for Diffusing Capacity according to the European Respiratory Society/American Thoracic Society (ERS/ATS) standards

· Carbon Monoxide Diffusing Capacity (DLCO)

· Single-breath or steady-state methods

· Gas dilution or washout

· Must have for Specialty testing according to the European Respiratory Society/American Thoracic Society (ERS/ATS) standards

· Bronchodilator responsiveness testing: Software with automated protocols for pre- and post-bronchodilator measurements.

· Challenge testing: Capability to perform methacholine challenge tests.

· Integrated cardiopulmonary exercise testing (CPET) system: Combines PFT measurements with ECG, blood pressure, and gas exchange analysis for comprehensive assessment of exercise capacity.

· Forced Oscillation Technique system: measures patented expiratory flow limitation technology (EFL) and quantifies the degree of obstruction through changes in reactance during the breath cycle for adults and pediatric patients.

· Nitrogen Washout: FRC-N2 to measure lung volumes and lung clearance index (LCI) measurement by multi-breath Nitrogen washout.

· Accuracy and Repeatability:

· Compliance with ERS/ATS standards for spirometry and lung volume measurements.

· High signal-to-noise ratio for accurate data acquisition.

· Minimal drift and consistent performance over time.

· Patient Safety:

· Single-patient use or disposable mouthpieces and nose clips to prevent cross-contamination.

· Built-in safety features like automatic leak compensation and effort detection.

· Emergency stop button for immediate test termination.

· Data Management and Reporting:

· Electronic data storage and retrieval.

· Customizable reports with predicted values, z-scores, and graphical representations.

· Ability to export data in various formats (e.g., PDF, CSV).

· Connectivity options for integration with Electronic Medical Records (EMR) systems.

II. Usability and Ergonomics

· User-friendly interface: Intuitive software with clear instructions and real-time feedback.

· Easy to clean and maintain: Durable materials that are resistant to disinfectants.

· Portable and compact design: For use in different clinical settings.

· Adjustable patient chair and mouthpiece positioning: To accommodate patients of different sizes and abilities.

· Quiet operation: To minimize patient discomfort and distractions.

III. Exercise Testing Equipment

· Treadmill:

· Medical grade with adjustable speed and incline.

· Integrated safety features (e.g., emergency stop, heart rate monitoring).

· Capable of accommodating a range of patient sizes and fitness levels.

· Bike:

· Medical grade with adjustable resistance levels to perform exercise induced bronchospasms.

· Recumbent ergometer for easy positioning and access.

· Comfortable and adjustable seating for various patient sizes.

· Integrated safety features (e.g., emergency stop, heart rate monitoring).

IV. Optional Features

· Pulse oximetry integration: For monitoring oxygen saturation levels during testing.

· Advanced reporting features: Interpretation software with customizable templates and automated quality control checks.

V. Purchasing Considerations

· Vendor support and training: No less than 32 hours clinical training on all equipment collectively. Service training for Biomedical Equipment Technicians to allow for maintenance of equipment.

· Warranty agreements: Comprehensive coverage for repairs and maintenance. Minimum standard 1 year Manufacturer’s Warranty.

· Integration with existing systems: Compatibility with existing EMR or practice management software. Active ATO required as determined by CSTAR.

VI. Specific Requirements

· Define the intended patient population: Both, adult and pediatric.

· Consider the specific testing needs: Basic spirometry, body Plethsmography, gas dilution and washout and specialty testing like methacholine challenges, exercise testing, CPEX testing and forced oscillation technique.

· Determine the required testing volume: 5-6 full PFT patients per day, 2-10 spirometry patients per day, 1-4 methacholine challenges per month, 1-2 exercise induced bronchospasms a month and 1 CPEX per quarter

· Evaluate the available space and infrastructure: Adequate Power supply, ventilation, and data connectivity, considering the footprint of the treadmill and bike.