Technical and Functional Assessment of 10 Office Spirometers: Setting

The study was divided into an in-laboratory study and an assessment of user friendliness of the office spirometers. The in-laboratory study was performed in the pulmonary function laboratories of three academic hospitals in Belgium.
For the user-friendliness assessment, the office spirometers were also presented to three GPs working in the general practice department of the three universities. The same office spirometers were used successively in the three laboratories and by the three GPs according to their availability.
The sales representatives of the office spirometers were asked to demonstrate the devices in each center. At the moment of the study, Sibelmed (Barcelona, Spain) was not represented in Belgium and the two Sibelmed spirometers (Datospir 70 and Datospir 120) were not demonstrated. We scrupulously followed the instructions of the manufacturers, in particular concerning the handling of the devices and the need for calibration checks. According to instruction manuals, the majority of the office spirometers do not need calibration.
The 10 office spirometers were tested independently in the three laboratories following the same protocol. The office spirometers were compared to standard diagnostic spirometers: Vmax 20C (SensorMedics; Bilthoven, the Netherlands; software: 5/2A, 2002) in two centers and Morgan TLC (Morgan Medical; Rainham, UK; software: Mdas 4.01, 1999) in one center. These devices are calibrated daily and used by expert technicians (ETs) only. The Vmax 20C, a flow-sensing spirometer, was calibrated with a 3-L syringe at three different speeds; the Morgan TLC, a volume-sensing device, using a single speed, was calibrated as recommended by the manufacturer. The Morgan TLC was checked daily for leaks. A log of calibration results and leaks checks was maintained.
In each laboratory, three ETs tested all the office spirometers. We first checked the ability of the ETs themselves to perform reproducible pulmonary function tests (PFTs), and the interchangeability of the results between the three centers. Only technicians able to blow five times successively with maximum variations of FEV1 or FVC of 200 mL or 6% were selected. All were nonasthmatic nonsmokers and were free of respiratory symptoms.

This entry was posted in Spirometers and tagged comparative study, COPD detection, pulmonary function tests, spirometer, spirometry.