Spirometer Manufacturer & Model Information

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
NIOSH CWHSP Spirometry Table
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:

  1. Spirometry systems must have routine calibration checks.
  2. Graphic displays must provide real-time, volume-time, and flow-volume curves during tests. Displays must meet or exceed a minimum size.
  3. Spirometer software must automatically perform quality assurance checks on expiratory maneuvers during each testing session.
  4. Each spirometer must store absolute values from at least 8 maneuvers within one testing session.
  5. Spirometry software must save curves and results from all maneuvers or for three acceptable maneuvers at a minimum.
  6. Spirometry data files must save a record of the parameters defined in the 2005 ATS/ERS specifications.
  7. Spirometers that digitally transfer results must use the format, content, and data structure defined in the 2005 ATS/ERS specifications.