What to know
The NIOSH Coal Workers’ Health Surveillance Program (CWHSP) provides respiratory health screening and surveillance to U.S. coal miners. Under this program, coal miners are entitled to respiratory health screening including spirometry when initially employed in coal mining and periodically throughout their careers. This page provides spirometer guidelines for health facilities and clinics.
Regulations for spirometers
CWHSP standards for spirometry testing are provided in the U.S. Code of Federal Regulations 42 Part 37 Approval of Spirometry Facilites. Approved CWHSP health facilities interested in providing respiratory health screening for miners must use spirometers that meet federal regulations.
Electronic spirometry data files must include raw, flow data points, at ≥ 100 Hz, for each forced expiratory maneuver. This allows NIOSH to reconstruct individual maneuver spirometry curves for miner testing quality review.
CWHSP spirometer manufacture table
The table below provides spirometer manufacture and model information that currently meet or are working towards meeting regulatory requirements. This table is periodically updated as changes are made.
NIOSH requires spirometry facilities to submit CWHSP spirometry reports via electronic data transfer in CSV or XML format. Manufacturers interested in this program can participate by ensuring their equipment meets the CWHSP regulatory standards and electronic data capabilities.
Contact NIOSH at NIOSHbreathe@cdc.gov for more information.
| Manufacturer | Model | Software Version | CWHSP PDF report printout approved |
Manufacturer developing electronic data transfer for this model |
Approved for CWHSP Spirometry |
|---|---|---|---|---|---|
| Benson | CCS-200 CCS-200 / Plus |
Version 8.11 Version 8.10 |
X | X | X |
| COSMED | Microquark | OMNIA | X | X | |
| Quark | OMNIA | X | X | ||
| Pony FX | OMNIA | X | X | ||
| Depisteo | SPIROLYSER Q13 | SPIROWIN EXPERT Version: > 3.00 | X | X | X |
| MGC Diagnostics | Platinum Elite Series | BreezeSuite Version > 8.6 SP1 | X | X | X |
| Ultima Series | X | X | X | ||
| CPFS/D | X | X | X | ||
| Morgan Scientific | Pneumotrac | ComPas | X | X | |
| Body | Plethysmograph | X | X | ||
| ndd Medical Technologies, Inc. | Easy on-PC | X | X | X | |
| EasyOne Air | X | X | X | ||
| EasyOne Pro/LAB | X | X | X | ||
| Vitalograph | Pneumotrac | Spirotrac Version 1.19 | X | X | X |
| COMPACT Workstation | Spirotrac Version 1.19 | X | X | ||
| Vyaire Medical (formerly CareFusion) | Vyntus SPIRO, ONE, BODY | Any version ≥ SentrySuite 2.21 | X | X | X |
| Masterscreen | Any version ≥ SentrySuite 2.21 | X | X | X | |
| Masterscreen (with JLAB) | X | ||||
| Vmax Encore (all models) | X |
Table last updated: 4/2023
Minimum spirometry testing equipment capabilities
It is the facility's responsibility to ensure that equipment is set up to meet requirements for testing. Spirometry equipment must meet the 2005 ATS/ERS Standardization of Spirometry specifications for accuracy, precision, and real-time display size. Specifications include:
- Spirometry systems must have routine calibration checks.
- Graphic displays must provide real-time, volume-time, and flow-volume curves during tests. Displays must meet or exceed a minimum size.
- Spirometer software must automatically perform quality assurance checks on expiratory maneuvers during each testing session.
- Each spirometer must store absolute values from at least 8 maneuvers within one testing session.
- Spirometry software must save curves and results from all maneuvers or for three acceptable maneuvers at a minimum.
- Spirometry data files must save a record of the parameters defined in the 2005 ATS/ERS specifications.
- Spirometers that digitally transfer results must use the format, content, and data structure defined in the 2005 ATS/ERS specifications.