Spirometer Manufacturer & Model Information

What to know

The NIOSH Coal Workers’ Health Surveillance Program (CWHSP) provides respiratory screening and surveillance for U.S. coal miners. Spirometry is included in the screening. This page provides spirometer guidelines for health facilities and clinics.

Regulations for spirometers

CWHSP standards for spirometry are provided in the U.S. Code of Federal Regulations 42 Part 37 Approval of Spirometry Facilites. Approved facilities interested in providing respiratory screening for miners must use spirometers meeting 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.

Approved spirometer models & manufactures

Below is a list that provides model and manufacture information that currently meet data transfer requirements and software versions approved for a given manufacture.

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 standards and electronic data transfer capabilities. Contact NIOSH at NIOSHbreathe@cdc.gov for more information.

Benson

  • Models: CCS-200, CCS-200/Plus
  • Software Versions: Version 8.11, Version 8.10

Depisteo

  • Models: SPIROLYSER Q13
  • Software Versions: SPIROWIN EXPERT Version ≥ 3.00

MGC Diagnostics

  • Models: Platinum Elite Series | Ultima Series | CPFS/D | Meridian
  • Software Versions: BreezeSuite 8.6 SP1 or higher | Ascent v2.4.1 or higher

ndd Medical Technologies, Inc.

  • Models: Easy on-PC | EasyOne Air | EasyOne Pro/LAB
  • Software Versions: EasyOne Connect

Vitalograph

  • Models: Pneumotrac | COMPACT Workstation
  • Software Versions: Spirotrac Version 1.19

Vyaire Medical (formerly CareFusion)

  • Models: Vyntus SPIRO, ONE, BODY | Masterscreen
  • Software Versions: Any version ≥ SentrySuite 2.21

Minimum spirometry testing equipment capabilities

It is the facility's responsibility to ensure that equipment meets 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.
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Content Source:
National Institute for Occupational Safety and Health